Clinical Trials

An Open, Non-comparative Study of the Efficacy and Safety of Treatment of Acne Scars With Restylane Vital Lidocaine

Clinicaltrials.gov (Mar 2013)

The purpose of this study is to demonstrate the efficacy and safety of Restylane Vital Lidocaine when acne scars are treated

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Effects of Omega-3 Fatty Acid Supplementation in Acne Patients

Clinicaltrials.gov (Jan 2013)

60 patients receiving isotretinoin and 90 subjects receiving oral antibiotic therapy will be recruited from the UCLA acne specialty clinic. Subjects will be randomized in a 1:1 ratio to receive placebo or omega-3 1200mg twice a day for 24 weeks.

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Treatment of Atrophic Acne Scars With a Fractional CO2 Laser at 1 Versus 3 Months Intervals

Clinicaltrials.gov (Jan 2013)

To compare efficacy and adverse effects of fractional CO2 laser of acne scars treatment with 1 versus 3 months intervals

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A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients

Clinicaltrials.gov (Sep 2012)

Exploratory, international, multi-centre, randomized, investigator blinded study in acne

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A Proof of Concept Study to Evaluate the Effectiveness of Ustekinumab in Hidradenitis Suppurativa (HiTS)

Clinicaltrials.gov (Aug 2012)

The purpose of this study is to determine whether ustekinumab is effective in the treatment of moderate to severe hidradenitis suppurativa.

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A Clinical Trial Evaluating the Safety and Efficacy of the KLOX Biophotonic System in Moderate to Severe Acne

Clinicaltrials.gov (Apr 2012)

The purpose of this study is to evaluate the safety and efficacy of the KLOX Biophotonic System in patients with moderate to severe facial acne vulgaris using a split-face design (treated hemiface vs untreated hemiface).

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A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne

Clinicaltrials.gov (Aug 2011)

There are many different factors that cause acne. So combination treatment using different medications that can address these different factors is commonly used to treat acne. Fixed-dose combination clindamycin phosphate 1.2% and tretinoin 0.025% gel and

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Exploratory study to assess facial tolerability after daily application of several concentrations and formulations containing CD5789 in acne subjects

Clinical Trials Register.eu (Apr 2011)

To evaluate the facial tolerability and subject’s adherence to treatment of different formulations of CD 5789 when applied QD over 4 weeks by acne subjects, in comparison with Tazarotene 0.1%.

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Efficacy and Safety comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Lymecycline 300mg Capsules versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules in the Treatment of Moderate to Severe Acne Vulgaris.

Clinical Trials Register.eu (Mar 2009)

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris.

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Exploratory Study to Evaluate the Efficacy and Safety of CD5789 in Subjects with Acne

Clinical Trials Register.eu (Mar 2009)

The objective of this study is to evaluate the efficacy on acne lesions and the safety of CD5789 0.01% and 0.005% after four weeks of once daily application compared to its gel vehicle using clinical and photographic evaluations.

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International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010

Clinicaltrials.gov (Feb 2013)

The main goal of this study is to improve the outcome of children and adolescents with standard risk first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a large international study group platform allowing for optimization of standard treatment strategies and integration of new agents.

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Retrospective Evaluation of the Clinical Results Obtained in Patients With Acute Lymphoblastic Leukemia Treated at the San Giovanni Battista Hospital. (ALL)

Clinicaltrials.gov (Feb 2013)

This study provides for the collection of a series composed by patients with newly diagnosed of acute lymphoblastic leukemia in the period 1999-2011. This collection is carried out with retrospective investigation, through the review of paper and electronic records and data cards in large part already collected as part of study protocols "GIMEMA" or "BFM" or "NILG" approved by the Ethics Committee of Hospital. The purpose of data collection is to check with retrospective predictability of classical risk factors in relation to disease response, and overall survival of the event-free survival, to estimate the cumulative incidence of competitive events such as the emergence of disease, acute and chronic transplant, the transplant-related mortality and relapse of disease.

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Effect of Bovine Colostrum on Toxicity and Inflammatory Responses (CALL)

Clinicaltrials.gov (Jan 2013)

The aim of the present study is to evaluate the ability a colostrum containing diet to limit gastrointestinal toxicity including chemotherapy induced inflammation in children treated for acute lymphoblastic leukemia.

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A Phase I, Dose-finding Study of BEZ235 in Adult Patients With Relapsed or Refractory Acute Leukemia

Clinicaltrials.gov (Dec 2012)

To establish the maximum tolerated dose (MTD), and the recommended Phase 2 dose (RP2D) of BEZ235 when administered twice daily (BID) as a single agent in patients with relapsed or refractory acute leukemia To determine the dose-limiting toxicity (DLT)

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Protocol ALL-11:Treatment study protocol of the Dutch Childhood Oncology Group for children and adolescents (1-19 year) with newly diagnosed acute lymphoblastic leukemia

Clinical Trials Register.eu (Jul 2012)

To treat children with ALL with the best available treatment as possible, based upon the risk factors of the patient at diagnosis.

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A Phase II study with a sequential clofarabine-cyclophosphamide combination schedule as salvage therapy for refractory and relapsed acute lymphoblastic leukemia (ALL) in adult patients

Clinical Trials Register.eu (Jun 2012)

The primary objective of this trial is to assess the activity - in terms of percentage of CR - of Clofarabine in combination with Cyclophosphamide in adult patients with refractory and relapsed (≤24 months from first CR) ALL.

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Double blind placebo controlled randomized intervention study aiming at reducing dexamethasone related side effects in children with acute lymphoblastic leukemia (ALL).

Clinical Trials Register.eu (May 2012)

To reduce dexamethasone induced cerebral side-effects on mood, behaviour, and cognition by intervention treatment with physiological doses of cortisol compared to placebo.

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An Open-label, Randomized Phase 3 Study of Inotuzumab Ozogamicin Compared to a Defined Investigator’s Choice in Adult Patients with Relapsed or Refractory CD22-Positive Acute Lymphoblastic Leukemia (ALL)

Clinical Trials Register.eu (May 2012)

To compare the hematological remission, defined as CR (both CR and CRi), as reported by the external independent endpoint adjudication committee, in patients with relapsed/refractory ALL randomized to receive inotuzumab ozogamicin (Arm A) versus patients randomized to receive active comparator (Arm B).

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United Kingdom National Randomised Trial for Children and Young Adults with Acute Lymphoblastic Leukaemia and Lymphoma 2011

Clinical Trials Register.eu (Sep 2011)

The UKALL 2011 trial will examine whether three changes to current standard therapy improves survival and reduces side effects in patients suffering from acute lymphoblastic leukaemia and lymphoblastic lymphoma. The following questions will be answered: 1) Does exposure to the steroid dexamethasone for a shorter period but at a similar total dosage than is currently used during the first month of treatment, result in fewer side effects whilst maintaining efficacy of treatment. 2) Does the use of methotrexate in high dose, reduce risk of relapse involving the central nervous system. 3) Is it possible to omit monthly pulses of vincristine and dexamethasone, currently given for up to 30 months, without increasing the risk of relapse, thereby reducing side effects and improving health related quality of life.

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Phase 1 Study of Combotox With Cytarabine in Relapsed/Refractory B-lineage Acute Lymphoblastic Leukemia (ALL)

Clinicaltrials.gov (Jul 2011)

This study will test different doses of combotox in your disease to find out what dose of this drug can be given safely to patients. Combotox will be given with cytarabine. You might have been given cytarabine as part of your treatment for ALL before; even if you have received cytarabine before, it usually still works when it is given if the leukemia has not completely disappeared with the first treatment (or is "refractory") or if the leukemia has come back (or has "relapsed"). Another purpose of this study is to find out what effects (good and bad) the experimental drug Combotox has on you and your disease (ALL) when combined with cytarabine.

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Prediction and Prevention of PEG-Asparaginase Associated Pancreatitis, Hepatotoxicity and Hyperlipidemia in Children With Acute Lymphoblastic Leukemia

Clinicaltrials.gov (Jul 2011)

The purpose of this study is to create a model enabling us to predict pancreatitis, hyperlipidemia and hepatotoxicity during treatment with PEG-Asparaginase in children with Acute Lymphoblastic Leukemia.

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Utility of XCL1 as a Prognostic Marker in Acute Lymphoblastic Leukemia

Clinicaltrials.gov (Jun 2011)

The purpose of the study is to determine the utility of XCL1 in the prognosis of acute lymphoblastic leukemia.

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Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph 'Negative in Elderly Patients (> 55 Years)

National Cancer Institute (Jun 2011)

The protocol objective is providing adequate treatment and based on broad consensus in elderly patients with Acute Lymphoblastic Leukemia (ALL). Apply uniform treatment that enables a joint analysis of results strong enough to make conclusions on specific subgroups of patients (genotypic subtypes, particularly LAL Bcr/abl positive, phenotype, or strata of age or associated diseases). Provide results of a treatment to consider standard against which to compare the results of phase II trials of experimental drugs that undoubtedly will be activated in the coming years.

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PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph' Negative Over 55 Years

National Cancer Institute (May 2011)

The biological characteristics of the adult LAL, karyotypic and phenotypic particular, are fundamentally different from those of Acute Lymphoblastic Leukemia (ALL) children and, consequently, the results of treatment are substantially lower. Additionally, elderly patients tolerate the drugs considered relatively low-key in the management of the LAL and suffer more toxicity. Although the LAL is much more common in patients over 60 years of age than in younger adults, older adults with ALL are clearly underrepresented in prospective controlled studies. A good portion of elderly patients are not able to tolerate the intensity of the standard treatment applied to children or young adults and a significant portion of them receive only palliative or supportive treatment. The data in the literature relating specifically to the elderly population are scarce and most of them have obtained a stratification by age of study designed for young people (CALGB, GMALL, PETHEMA). To date, the group's recommendation was to treat PETHEMA the LAL-96RI protocol for elderly patients because this protocol less aggressive than those used in high-risk ALL. However, the development of inhibitors of tyrosine kinases LAL effective in Bcr / abl positive, a relatively common type of LAL in the older patient, requires a differentiated treat these patients. Moreover, analysis of data from patients treated so far with the LAL-96RI protocol has shown mediocre results even for LAL Bcr / abl negative. This analysis also showed a significant benefit in survival related to the reduction of treatment (removal of the L-asparaginase during induction and cyclophosphamide at the end of induction) attributed to a reduction in toxicity.

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German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

National Cancer Institute (May 2011)

The study evaluates the efficacy and tolerability of a dose-reduced chemotherapy for the treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression of CD20 on leukemic cells the efficacy and tolerability of additional application of Rituximab together with chemotherapy is evaluated.

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Trial for the Treatment of Newly Diagnosed Mature B-Cell Acute Lymphoblastic Leukemia (B-ALL), Burkitt's Non-Hodgkin's Lymphoma (NHL) and Other High-Grade Lymphoma in Adults

National Cancer Institute (May 2011)

The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.

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Patient Activation, Consultation and Exercise - Acute Leukemia (PACE-AL)

National Cancer Institute (May 2011)

The purpose of this study is to test a new preventive and restorative intervention for patients with acute leukaemia undergoing consolidation chemotherapy, to measure and delineate the patients' treatment related symptom burden and to explore the effect of the intervention on length of hospital stay, duration of sick leave and return to work status. Further, to examine the relationship of the symptom profile with clinical indicators, physiological response, physical performance and survival.

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Treatment Protocol for young adults (18-45 years of age) with Acute Lymphoblastic Leukemia

Clinical Trials Register.eu (Mar 2011)

To increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualised intensification of the 6MP-dosage days 30-85. We will additionally measure EFS and toxicity as secondary end points of effect. To test if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of EFS. As secondary endpoints asparaginase antibody production and toxicity including allergic reactions in the treatment-arms will be analysed. To test if replacing six doses of conventional triple i.t. therapy with DepoCyte® during maintenance therapy for HR-ALL will yield an equal or reduced rate of serious toxicity (SAEs and SUSARs) with a similar or decreased CNS- and overall relapse rate

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Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia (Vandevol)

Clinicaltrials.gov (Jan 2011)

The purpose of this study is to determine Maximum Tolerated Dosage (MTD), Dosage Limited Toxicities (DLT), and the Rate Phase 2 Dosage of clofarabine when used in combination with etoposide, asparaginase, mitoxantrone and dexamethasone and to assess the feasibility and safety of this combination regimen to treat children with high risk relapsed or refractory acute lymphoblastic leukemia (ALL).

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Optimized Radiological Diagnosis of Hepatic Candidiasis During the Treatment of Acute Leukemias

National Cancer Institute (Sep 2010)

Hepatic candidiasis is a frequent complication in patients receiving intensive chemotherapy for acute leukemia. Hepatic lesions may be detected by computerized tomographic (CT) scans, but there is no standardized CT protocol for the diagnosis and follow-up of hepatic candidiasis. The investigators compared the size of the fungal lesions in the chest and abdomen CT. The current analysis aimed to increase the value of CT for the diagnosis and the follow-up of hepatic candidiasis in daily routine.

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Efficacy of Dexamethasone Switch in Prednisolone Resistant Adult ALL and Prolonged L-asparaginase in Non-interrupted Schedule

National Cancer Institute (Aug 2010)

Evaluation of blast clearance in b/m after 7 days of prednisolone prephase and the efficacy of its substitution by dexamethasone if blast count is 25% and more. Feasibility for adults of "no interruptions" protocol with 8 weeks induction and 14 weeks consolidation followed by 2-years maintenance. Tolerability and efficacy in adults of the prolonged L-asparaginase application (total proposed dose 560.000 IU) Feasibility and efficacy of autologous HSCT for T-cell ALL.

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A randomized, multi-centre, parallel-group, open label, Oncaspar® controlled dose ranging trial of three doses of pegylated recombinant asparaginase in adult patients with newly diagnosed acute lymphoblastic leukaemia.

Clinical Trials Register.eu (Aug 2010)

Assessment of efficacy and safety of three different doses of pegylated recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults with de novo acute lymphoblastic leukaemia (ALL) primary objective:-To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.

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A confirmatory multicenter, single-arm study to assess the efficacy, safety, and tolerability of the BiTE® antibody blinatumomab in adult patients with minimal residual disease (MRD) of B-precursor acute lymphoblastic leukemia

Clinical Trials Register.eu (Jun 2010)

To evaluate the efficacy of blinatumomab to induce complete MRD response

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Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Clinicaltrials.gov (Jun 2010)

This research study is developing a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia.

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Osteonecrosis in Children With Acute Lymphoblastic Leukemia

Clinicaltrials.gov (Apr 2010)

Acute lymphoblastic leukemia is the most common form of childhood cancer with current treatment survival rates approaching 80%. Improved outcomes show an increased number of survivors at risk for long-term treatment related side effects including osteonecrosis. Osteonecrosis, or bone death, is caused by blood supply loss to the bone causing pain and poor quality of life. The hips, shoulders, knees and ankles may be affected. Pain is the usual presenting symptom and may become severe requiring surgical decompression or replacement of the affected joint. Long-term effects including arthritis and progressive joint difficulties will not be known for decades. This study aims to determine the risk factors for developing osteonecrosis that will lead to information for earlier detection and prevention. The study will be the basis for future intervention and prevention trials.

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Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients

National Cancer Institute (Mar 2010)

This is a study to compare the efficacy and tolerability of two laxatives for treatment of opioid-induced constipation in adult outpatients with cancer treated at the BC Cancer Agency Pain and Symptom Management/Palliative Care clinics. Each participating patient will be randomly assigned to one of two treatment groups.

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UKALL14 - A randomized trial for adults with newly diagnosed acute lymphoblastic leukemia

Clinical Trials Register.eu (Mar 2010)

To determine if the addition of monoclonal antibody to standard induction chemotherapy results in improved event free survival in patients with precursor B-cell ALL (aim 1B). To determine if the addition of nelarabine improves outcome for patients with T cell ALL (aim 1T)

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A non-randomized, open-label study to characterize the pharmacokinetics of Glivec/Gleevec® (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)

Clinical Trials Register.eu (Mar 2010)

To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated physiologically-based pharmacokinetic (PBPK) and population pharmacokinetics (pop PK) approaches. To assess the safety and tolerability of imatinib in pediatric patients age 1 to less than 4 during the study period.

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An open-label, randomised crossover pharmacokinetic, palatability and safety study to assess the bioavailability of a new 6MP oral liquid formulation by comparison to a currently registered 6MP 50 mg adult tablet (part A) followed by an open, non-randomised multiple-doses study with adjusted doses of 6MP oral liquid formulation (part B) in children with acute lymphoblastic leukaemia.

Clinical Trials Register.eu (Feb 2010)

To characterise the bioavailability of a single 50 mg fixed dose of the O4CP innovative oral liquid formulation versus 50mg registered adult tablets and to assess the pharmacokinetics of an adjusted dose of the O4CP innovative oral liquid formulation given daily for 6 weeks

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Front-line treatment of Ph positive (Ph+)/Bcr-Abl positive Acute Lymphoblastic Leukemia (ALL) with two tyrosine kinase inhibitors (TKI) (Imatinib and Nilotinib). A phase II exploratory multicentric study in elderly patients and in patients unfit for program of intensive therapy and allogeneic stem cell transplantation

Clinical Trials Register.eu (Nov 2009)

The objective of the trial is to evaluate the therapeutic effects of NIL and IM given in turn (in rotation) in terms of Disease-Free Survival (DFS) at 24 weeks (after 4 courses of treatment).

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Treatment of High Risk Adult Acute Lymphoblastic Leukemia

National Cancer Institute (Feb 2009)

Current therapeutic protocols for adult ALL consider MRD together with the baseline risk factors (age, WBC count, immunophenotype, cytogenetics) and speed in response to therapy for treatment decisions. On the other hand, the systematic use of allogeneic SCT for all adult patients (pts) with Ph- HR-ALL is still a matter of debate. The aim of the prospective study ALL-AR-03 from the Spanish PETHEMA Group was to evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels (assessed by cytofluorometry at the end of induction and consolidation therapy) in HR Ph- adult ALL patients.

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Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults

National Cancer Institute (Dec 2008)

All patients are treated according to the same therapy regimen. Therapy duration (number of cycles) and radiotherapy vary according to age group, stage and response. Chemotherapy consists of a pre-phase-treatment (for all patients) and varying A, B and C cycles.

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ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy (ALL2008con)

Clinicaltrials.gov (Dec 2008)

Nordic Society of Paediatric Haematology and Oncology (NOPHO) Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults With Acute Lymphoblastic Leukemia. Efficacy of Individualised 6MP Dosing During Consolidation Therapy.

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Intrathecal DepoCyte and Lineage-targeted Minimal Residual Disease-oriented Therapy of Acute Lymphoblastic Leukemia

National Cancer Institute (Nov 2008)

In this multicentric prospective pilot randomized phase II trial on CNS prophylaxis, all patients receive induction/consolidation therapy incorporating lineage-targeted high-dose methotrexate plus other drugs (with additional imatinib in Ph/BCR-ABL+ ALL), for the achievement of an early negative MRD status. The MRD study supports a risk/MRD-oriented final consolidation phase

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Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia

Clinicaltrials.gov (Apr 2008)

The goal of this clinical research study is to learn if intensive chemotherapy (with monoclonal antibody therapy in some patients) given for 8 courses over 5 to 6 months followed by monthly maintenance chemotherapy for 2 ½ years can improve or cure acute lymphoblastic leukemia or lymphoblastic lymphoma.

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Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who are Experiencing Clinical Benefit on Current START Protocols: Long Term Safety and Efficacy Analysis.

Clinical Trials Register.eu (Oct 2007)

The primary objective is to determine the long term safety and tolerability of dasatinib. The secondary objective of this study is to collect long term efficacy in terms of molecular response.

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An open label phase II study to evaluate the efficacy and safety of induction and consolidation therapy with dasatinib in combination with chemotherapy in patients aged 55 years and over with philadelphia chromosome positive (PH+ or BCR-ABL+) acute lymphoblastic leukemia (ALL).

Clinical Trials Register.eu (Jun 2007)

To evaluate the efficacy of a dasatinib-based induction and consolidation therapy

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A Phase II Study of MK-0457 in Patients With BCR-ABL T315I Mutant Chronic Myelogenous Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Clinical Trials Register.eu (Jan 2007)

To evaluate the efficacy of MK-0457, as defined by major cytogenetic response in chronic phase CML and as major hematological response in accelerated phase CML, blastic phase CML, and Ph+-ALL, when given as a 5-day CIV infusion every 14 days. To evaluate the safety of MK-0457 with this dose and regimen.

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Allogenic stem cell transplantation in children and adolescents with acute lymphoblastic leukaemia

Clinical Trials Register.eu (Jan 2007)

To evaluate whether HSCT from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). To evaluate the efficacy of HSCT from mismatched family or unrelated donors (MMD) as compared to HSCT from MSD/MD. To determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. To prospectively evaluate and compare the incidence of acute and chronic GvHD after HSCT from MSD, from MD and from MMD.

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A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (CGX-635) in the Treatment of Refractory or Relapsed Acute Myeloid Leukemia (AML)

Clinical Trials Register.eu (Oct 2006)

To evaluate the safety and efficacy of the subcutaneous administration of homoharringtonine (HHT) in the treatment of patients with refractory or relapsed acute myeloid leukemia (AML). Secondary endpoints include duration of treatment response, survival, induction mortality and hospitalizations.

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NOPHO-DBH AML 2012 Protocol Research study for treatment of children and adolescents with acute myeloid leukaemia 0-18 years

Clinical Trials Register.eu (Mar 2013)

The AML 2012 study is a treatment and research protocol with the overall aim of improving prognosis for children and adolescents with AML. This is to be achieved by better risk stratification based on MRD quantification and more intensive induction compared to previous NOPHO protocols. Specific research aims are 1) To investigate if DaunoXome® has a higher efficacy than Mitoxantrone, when given in course 1 for treatment of pediatric AML 2) To investigate if FLADx has a higher efficacy than ADxE when given as the second induction course for treatment of pediatric AML 3) To investigate the correlation between MRD measurement by PCR and flow cytometry and the prognostic impact of MRD with either method after course 1 and 2 respectively.

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Respiratory Viral Infections During Acute Myeloid Leukemia (AML)Chemotherapy Related Aplasia (LAMVIRE)

Clinicaltrials.gov (Mar 2013)

Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia) induction and consolidation chemotherapies related aplasia. The main aim of this study is to measure incidence of respiratory viral infections during AML induction and consolidation chemotherapy related aplasia. Primary end point is a positive polymerase chain reaction(PCR)associated with clinical signs.

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A phase III randomised, double-blind, controlled, parallel group study of intravenous volasertib in combination with subcutaneous low-dose cytarabine vs. placebo + low-dose cytarabine in patients ≥ 65 years with previously untreated acute myeloid leukaemia, who are ineligible for intensive remission induction therapy.

Clinical Trials Register.eu (Feb 2013)

To investigate the efficacy, of intravenous volasertib + subcutaneous low-dose cytarabine in patients ≥ 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy. Efficacy will be determined primarily based on remission rate (CR+CRi) and overall survival (OS).

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Conventional and Experimental Chemotherapy With Allogeneic Transplant in Young Patients With Acute Myeloid Leukaemia (AML)

Clinicaltrials.gov (Feb 2013)

The purpose of this study is evaluate patients with acute myeloid leukemia (<=66 years), treated with conventional and experimental chemotherapy following allogeneic transplantation. THis patients have been enrolled from 2000 to 2011 at the Division of Hematology, Molinette University Hospital. The purpose of data collection is to assess, with retrospective analysis, the clinical outcome divided by risk class and evaluated in patients who achieve complete remission after induction therapy and consolidation.

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A phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects with Acute Myeloid Leukemia in Complete Remission

Clinical Trials Register.eu (Dec 2012)

The primary objective of the study is to demonstrate if maintenance therapy with oral azacitidine improves OS compared with placebo in subjects with AML, age >= 55 years, who have achieved first CR or CRi after induction with intensive chemotherapy with or without consolidation chemotherapy

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Phase II Randomised Trial of 5-Azacitidine versus 5-Azacitidine in combination with Vorinostat in patients with Relapsed Acute Myeloid Leukaemia ineligible for Intensive Chemotherapy

Clinical Trials Register.eu (May 2012)

To evaluate the activity of azacitidine and vorinostat combined therapy, in terms of overall response (OR) (complete remission (CR), complete remission with incomplete blood count recovery (CRi) and partial remission (PR), as defined by Cheson criteria) and overall survival (OS) in patients with relapsed AML who are ineligible for intensive chemotherapy.

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A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects with FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Clinical Trials Register.eu (May 2012)

The primary objectives are to evaluate the rate of Grade 2 or higher QTcF prolongation and to evaluate the composite complete remission rate (CRc), defined as the confirmed rate of complete remission (CR) plus complete remission with incomplete platelet recovery (CRp) or incomplete hematological recovery (CRi) at different doses of AC220.

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Response-Adapted Sequential Azacitidine And Chemotherapy in Patients > 60 Years Old With Newly Diagnosed AML Eligible for Chemotherapy and allogeneic hematopoietic cell transplantation: A Multicentre Phase I/II study of the East German Hematology and Oncology Study Group (OSHO)

Clinical Trials Register.eu (Apr 2012)

The objective of the trial is to assess efficacy and safety of induction therapy with response-adapted sequential azacitidine and conventional AML induction chemotherapy in patients > 60 years with newly diagnosed AML (at the dose level resulting from the dose evaluation phase of the trial).

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A double-blind, placebo-controlled, randomized, multicenter phase II trial to assess the efficacy of temsirolimus added to standard primary therapy in elderly patients with newly diagnosed AML

Clinical Trials Register.eu (Jan 2012)

To compare the median Event Free Survival (EFS)* and the EFS probability of all AML patients between the temsirolimus and the control group * EFS defined as: Time interval from day 1 of study treatment until treatment failure, relapse from CR or CRi, or death from any cause, whichever occurs first. The time point at which the patient is resistant to therapy or survives induction without a CR, CRi or morphologic leukemia-free state will be recorded.

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Phase-II study evaluating midostaurin in induction, consolidation and maintenance therapy also after allogeneic blood stem cell transplantation in patients with newly diagnosed acute myeloid leukemia exhibiting a FLT3 internal tandem duplication AMLSG 16-10

Clinical Trials Register.eu (Jan 2012)

To evaluate the impact of midostaurin given in combination with intensive induction, consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on event-free survival (EFS) in adult patients with AML exhibiting a FLT3-ITD.

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NK Cell Based Non-Myeloablative Transplantation in (AML) Acute Myeloid Leukemia

Clinicaltrials.gov (Jun 2011)

This is a phase II multi-institutional therapeutic study of NK-cell based nonmyeloablative haploidentical transplantation for the treatment of high-risk acute myeloid leukemia (AML). Enrollment will use a two-stage design. Stage 1 will enroll 15 patients unless an early stopping rule is met. If 9 or more of these first 15 patients achieve leukemia free neutrophil engraftment at day +28 accrual will move to stage 2. In stage 2, an additional 28 patients will be enrolled for a total of 43 patients. Patients will be followed for disease response for 2 years.

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Lenalidomide, Lenalidomide + Azacitidine, or Standard Treatment Therapies in Newly Diagnosed Acute Myeloid Leukemia

Clinicaltrials.gov (May 2011)

The aim of the study is to investigate the effect of a lenalidomide regimen or a sequential azacitidine plus lenalidomide regimen relative to the conventional care regimens in subjects 65 years or older with newly diagnosed Acute Myeloid Leukemia (AML).

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Study of Maintenance Therapy With Ceplene® (Histamine) and IL-2 on Minimal Residual Disease in Acute Myeloid Leukemia

National Cancer Institute (May 2011)

Ceplene/IL-2 remission maintenance therapy has been shown to significantly prolong Leukemia Free Survival in patients with Acute Myeloid Leukemia (AML) in first complete remission. This is an international, multicenter, open-label study to evaluate the effects of remission maintenance therapy with Ceplene/IL-2 in adult patients with AML in CR1 on specific immune system cells (T and NK cells) and prospectively defined markers of immune response that are known to reflect T and NK cell ability to combat AML.

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Pre-hospital Risk Factors for Invasive Fungal Infection (SEIFEM 2010)

Clinicaltrials.gov (Mar 2011)

SEIFEM 2010 study is a prospective, multicenter registry designed to identify and analyze risk factors for developing an invasive fungal infection in patients with newly diagnosed Acute Myeloid Leukemia, with particular interest on pre-hospital risk factors (i.e. those related to normal activities of daily life, such as occupation, location and type of residence, consume of tobacco, alcohol and others).

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Caspofungin Acetate or Fluconazole in Preventing Invasive Fungal Infections in Patients With Acute Myeloid Leukemia Who Are Undergoing Chemotherapy

Clinicaltrials.gov (Mar 2011)

This randomized phase III clinical trial is studying caspofungin acetate to see how it works compared to fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy.

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Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome

National Cancer Institute (Sep 2010)

The purpose of this study is to compare the effects, good and/or bad, of posaconazole and micafungin in preventing fungal infections after chemotherapy for acute leukemia or myelodysplastic syndrome. When people take chemotherapy, they are more likely to get infections. Posaconazole has been approved for the prevention of fungal infections in patients who receive induction chemotherapy for acute leukemia and myelodysplastic syndrome. Posaconazole is available only as an oral suspension and has to be given with food. After chemotherapy, many patients are not able to tolerate food or oral medication because of severe mucositis. Patients unable to tolerate food and oral medications cannot take posaconazole.

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LENA-LMA-5:Lenalidomide in Acute Myeloid Leukemia (AML)

National Cancer Institute (Jul 2010)

The purpose of this study is to evaluate the effectiveness of post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5), who obtained complete remission after conventional induction chemotherapy. So, too, for those who no obtained response treatment (total resistance) or partial remission.

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Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients

Clinicaltrials.gov (Jun 2010)

The study aims at determining the feasibility of using maintenance Decitabine therapy following remission induction and consolidation in elderly Acute Myeloid Leukemia patients who are fit for aggressive therapy. Primary: Safety and tolerability of the decitabine regimen in the post remission state. Secondary: Disease-free survival - To determine the one-year disease-free survival in elderly patients with acute myeloid leukemia (AML) in complete remission treated with Decitabine as post-consolidation maintenance therapy.

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A Randomized Study to Evaluate the Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients (QoLESS AZA-AMLE)

Clinical Trials Register.eu (Jun 2010)

To evaluate 1. Overall survival (OS) at 2 years. Event for OS in both arms is death and patients are censored at the date of last contact if alive. 2. Disease-free survival (DFS) at 2 years. Events for DFS in both arms are death and first relapse (either AML or MDS recurrence). 3. Changes in quality of life from diagnosis in both arms.

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Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients

National Cancer Institute (Mar 2010)

This is a study to compare the efficacy and tolerability of two laxatives for treatment of opioid-induced constipation in adult outpatients with cancer treated at the BC Cancer Agency Pain and Symptom Management/Palliative Care clinics. Each participating patient will be randomly assigned to one of two treatment groups.

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LAM07: Study to Analyze the Efficacy of a Risk Adapted Treatment Strategy, Including Gemtuzumab Ozogamicin (GO) During Consolidation, for Patients With Acute Myeloid Leukemia (AML)

Clinicaltrials.gov (Dec 2009)

Prospective, multicenter, uncontrolled cohort study to analyze the efficacy of a risk adapted treatment strategy, including gemtuzumab ozogamicin (GO) during consolidation, for patients with acute myeloid leukemia (AML).

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A phase Ib, open-label, multi-center dose-finding study of oral panobinostat (LBH589) in combination with ara-C and mitoxantrone as salvage therapy for refractory or relapsed acute myeloid leukemia

Clinical Trials Register.eu (Nov 2009)

To determine the maximum-tolerated dose (MTD) in terms of the incidence of dose-limiting toxicity (DLT) of panobinostat in combination with ara-C and mitoxantrone at a fixed dose in adult patients with relapsed or is primary refractory acute myeloid leukemia (AML).

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Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)

National Cancer Institute (May 2009)

This is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for treatment of newly diagnosed AML patients, younger than 66 years.

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An open label phase II trial of Clofarabine and Temsirolimus in older patients with relapsed or refractory Acute Myeloid Leukemia (AML)

Clinical Trials Register.eu (Mar 2009)

The primary objective of the trial is to determine the complete response rate (CR/CRi) of older patients with relapsed or refractory AML when given 1 or 2 courses of low-dose Clofarabine combined with Temsirolimus.

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A Randomized Phase II Study of Clofarabine / Intermediate-Dose Cytarabine (CLARA) versus High-Dose Cytarabine (HDAC) as Consolidation in Younger Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML).

Clinical Trials Register.eu (Mar 2009)

2 years diease free survival following first remission achievement (CR or CRp) in younger patients with intermediate-risk or unfavorable-risk AML

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A Randomized, Risk and Age Adapted Comparison of the Dose-Dense Regimen S-HAM (sequential high dose cytosine arabinoside and mitoxantrone) versus Standard Double Induction for Initial Chemotherapy of Adult Patients with Acute Myeloid Leukemia

Clinical Trials Register.eu (Aug 2008)

Overall response rate (ORR), aiming at a 15% increase in the CR (complete remission)/CRi (incomplete peripheral recovery) rate by S-HAM induction versus conventional double induction [TAD – HAM for younger patients, HAM (- HAM) for elderly patients].

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ALFA 0703 : A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid (ATRA) in Combination with Chemotherapy or azacitidine as salvage therapy and Azacitidine as Maintenance Therapy in Older Patients with Acute Myeloblastic Leukemia (AML)

Clinical Trials Register.eu (Jun 2008)

Untreated AML patients aged more than 65 will be subjected to two randomizations (R1 and R2), in this study. The primary objective of the first randomization (R1) is to assess the benefit in terms of Event Free Survival (EFS) of untreated AML patients aged more than 65 years, treated with induction and consolidation chemotherapy courses, in one arm or with the same chemotherapy courses combined with ATRA in the other arm. The primary objective of the second randomization (R2) is to assess the benefit in terms of Relapse Free Interval (RFI) of maintenance with azacitidine in AML patients in CR, after induction and 4 to 6 consolidation courses of chemotherapy +/- ATRA.

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Phase I/II Study of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

Clinicaltrials.gov (Apr 2008)

The purpose of this study is to investigate the combination of gemtuzumab ozogamicin, mitoxantrone and etoposide as second line therapy in patients with acute myeloid leukemia.

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Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia

National Cancer Institute (Mar 2008)

This clinical trial is studying how well an autologous stem cell transplant works in treating patients with acute myeloid leukemia.

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Phase ll Study of the Adjunctive Use of Azacitidine in Patients Undergoing Reduced Intensity Allogeneic Transplantation for Acute Myeloid Leukaemia

Clinical Trials Register.eu (Feb 2008)

To assess the safety and tolerability of Azacitidine in patients following reduced intensity conditioned allogeneic transplantation for AML.

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Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia (UPCC 04407)

Clinicaltrials.gov (Feb 2008)

The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant to standard chemotherapy or are otherwise not eligible for conventional chemotherapy. Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects within normal and malignant cells that affect cell growth and cell death.

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Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation and Donor Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia or High-Risk Myelodysplastic Syndrome

Clinicaltrials.gov (Jan 2008)

This phase II trial studies the side effects and best dose of iodine I 131monoclonal antibody BC8 when given together with fludarabine phosphate, cyclophosphamide, total-body irradiation and donor bone marrow transplant and to see how well they work in treating patients with advanced acute myeloid leukemia or acute lymphoblastic leukemia or high-risk myelodysplastic syndrome.

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A Phase II multicenter study to assess the tolerability and efficacy of the addition of Bevacizumab to standard induction therapy in AML and high risk MDS above 60 years.

Clinical Trials Register.eu (Aug 2007)

The main objectives of this study are: to assess the safety and tolerability of bevacizumab added to standard induction chemotherapy for AML (frequency and severity of toxicities and the durations of neutropenia and thrombocytopenia) and to assess in a randomized comparison the effect of bevacizumab on the CR rate.

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Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)

National Cancer Institute (Jul 2007)

Previous studies shows that risk of relapse is higher in patients treated with ATO postremission in monotherapy , than in other that receive ATO plus chemotherapy or transplantation (TPH). Also, compared with chemotherapy, ATO induction and consolidation has a favorable impact in posterior response to transplantation. It is due to a low toxicity or a best quality of remission to TPH. It seems better, for these reasons, the intensification with TPH (autologous or allogenic) in patients with relapsed APL treated with ATO. For another hand, patients no candidates to TPH can be treated with ATO combined with other active agents in APL, as ATRA, anthracyclines o Mylotarg

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Phase II/III Randomized Study of Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

National Cancer Institute (Mar 2007)

Primary (patients considered fit for intensive treatment) Objectives: Compare the efficacy and toxicity of daunorubicin hydrochloride and cytarabine (DA) vs daunorubicin hydrochloride and clofarabine (DClo) as induction therapy in older patients with acute myeloid leukemia or high-risk myelodysplastic syndromes. Assess the value of gemtuzumab ozogamicin when given in combination with DA or DClo during course 1 of induction therapy. Compare a total of two vs three courses of treatment in patients who achieve at least partial remission (< 15% blasts) after course 1 of induction therapy. Compare the use of demethylation maintenance therapy comprising azacitidine vs no maintenance therapy in these patients. Assess the value of reduced-intensity allogeneic stem cell transplantation as consolidation in patients with matched donors.

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Timed-Sequential Induction in CBF-AML

Clinicaltrials.gov (Jan 2007)

The primary purpose of the protocol is to compare two modalities of timed-sequential induction in order to improve the results of the treatment of CBF-AML patients. This protocol also includes the biological characterization of the heterogeneity of these diseases (gene mutation and transcription profiles), as well as a centralized minimal residual disease monitoring and centralized evaluation of pharmacogenetic polymorphisms.

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Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)

National Cancer Institute (Dec 2006)

Primary objectives: To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL. To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival, as well as on the duration of remission and cumulative incidence of relapse in low- and intermediate-risk patients with APL. To evaluate the impact of the addition of ara-C to idarubicin courses of consolidation for high-risk patients (administered as in the original GIMEMA protocols) on the event-free, disease-free, and overall survival, as well as on the duration of remission and cumulative incidence of relapse. To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy in the whole series and in each treatment group in patients with APL.

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A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (CGX-635) in the Treatment of Refractory or Relapsed Acute Myeloid Leukemia (AML)

Clinical Trials Register.eu (Oct 2006)

To evaluate the safety and efficacy of the subcutaneous administration of homoharringtonine (HHT) in the treatment of patients with refractory or relapsed acute myeloid leukemia (AML)

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Cognitive Remediation in ADHD Children : Comparison Between Three Therapeutic Strategies : Cognitive Remediation With a Virtual Classroom Software and Methylphenidate and Supportive Psychotherapy (RECOGNITA)

Clinicaltrials.gov (Mar 2013)

The Attention Deficit Disorder with or without Hyperactivity (ADHD) is one of the most frequently found disorder in children. It is characterized by a triad of symptoms involving attention deficit, hyperactivity and impulsivity and having an impact on the functioning of the subject especially in terms of learning. Currently, main interventions to treat ADHD in children are stimulant medication or supportive psychotherapy. Data from recent studies highlight the use of stimulant drugs (amphetamine derivatives such as methylphenidate) to treat the core symptoms of ADHD children. These drugs are generally effective but their nature (psychostimulants) and adverse effects they cause (appetite suppression, sleep disturbances, headaches, motor tics, abdominal pain, irritability, nausea and fatigue) encourage the development of new therapeutic approaches. The use of supportive psychotherapy alone would have limited effect on symptoms of children with ADHD. Our aim is to test the use a cognitive remediation program using a virtual classroom in children suffering from ADHD.

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Essential Fatty Acids in Adult ADHD (OCEAN-GER)

Clinicaltrials.gov (Feb 2013)

The aim of this project is to investigate the effect of a dietary supplementation with essential fatty acids in adults on cognitive functions related to attention and impulse control in the general population and in individuals with a diagnosis of attention deficit hyperactivity disorder (ADHD).

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Efficacy of Omega-3/Omega-6 Fatty Acids in Pre-school Children at Risk for ADHD

Clinicaltrials.gov (Feb 2013)

The efficacy of PUFAs (as nutritional supplement) in/for pre-school children with ADHS symptoms will be evaluated in a randomised controlled doubleblind trail with children aged 3-6 years.

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The Effects of DHA on Attention Deficit and Hyperactivity Disorder (DADA)

Clinicaltrials.gov (Feb 2013)

The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in reducing Attention Deficit/Hyperactivity Disorder (ADHD) core symptoms in a clinical sample of children and adolescents with ADHD.

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Omega-3 Fatty Acids Supplementation in ADHD

Clinicaltrials.gov (Jan 2013)

The overarching aim of the proposed study is to assess whether omega-3 fatty acids supplementation can augment the effects of methylphenidate in children with ADHD. The investigators hypothesized that omega-3 fatty acids supplementation will be associated with improved ADHD symptoms.

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The Relationship of Essential Fatty Acids to Adult ADHD: The OCEAN Study (Oils and Cognitive Effects in Adult ADHD Neurodevelopment)

Clinicaltrials.gov (Dec 2012)

The aim of the study is to provide preliminary data on the relationship of Essential Fatty Acids (EFAs) to cognitive and electrophysiological measures of brain and behavioural functions in adults with attention deficit hyperactivity disorder (ADHD) and controls. This main aim will be achieved in two ways. First the investigators will measure the relationship of the various measures to blood levels of EFAs in ADHD cases and controls. Secondly, the potential effects of dietary supplementation with EFAs on cognitive-electrophysiological and behavioural measures in ADHD cases will be investigated. We will evaluate the extent to which changes in neuronal activity and cognitive performance are related to behavioural and functional measures over time. This is to be carried out by conducting a randomised controlled trial of fish oil supplementation in adults with ADHD (The OCEAN study: Oils and Cognitive Effects in Adult Neurodevelopment).

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Relapse prevention in children and adolescents with DSM-IV-TR conduct disorder treated with risperidone: a randomised, double-blind, placebo-controlled discontinuation study.

Clinical Trials Register.eu (Nov 2012)

The primary objective is to test the hypothesis that, after at least 16 weeks of daily administration (4 for titration, 12 of relatively stable dose, 4 of which at fixed doses; Study Period 1), risperidone given orally at a dose of 0.25-3.0 mg/day depending on body weight (equivalent to approximately 0.01-0.04 mg/kg/day is superior to placebo in preventing relapse of the symptoms of conduct disorder as assessed through a 12 week double-blind discontinuation trial (Study Period 2) of children and adolescents with conduct disorder and no developmental delay/mental retardation. This will be measured by comparing the mean change from the double-blind baseline to endpoint in the Nisonger Child Behaviour Rating Form Typical IQ version-ODD/CD disruptive behaviour composite total score (Aman et al., 2008) using all investigator ratings, based on all available information.

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A pilot study of Concerta XL in adult offenders with ADHD

Clinical Trials Register.eu (Oct 2012)

The main question is to evaluate the effectiveness of a standard treatment for ADHD on behavioural problems, that are associated with ADHD in young male prisoners. The primary question is whether there is a decrease in aggressive behaviour following treatment of ADHD in a prison setting. Aggression is one of the main problem behaviours within the prison and previous research has shown the strong link between ADHD and aggression within adult prison populations.

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Phase shift in adult ADHD of sleep and apetite.

Clinical Trials Register.eu (Sep 2012)

To investigate the best treatment of the Delayed Sleep Phase Syndrome in adults with ADHD.

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Guided Self-Help for Parents of Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

Clinicaltrials.gov (Aug 2012)

Cognitive-behavioral based guided self-help for parents of adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and effectiveness study. The treatment is offered under routine-care conditions of the health-care system in Germany. Practicability, treatment participation and effectiveness is documented and tested in a one-group pre-test/post-test design.

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Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support

Clinicaltrials.gov (Jun 2012)

The main purpose of this study is to evaluate the effectiveness of a parenting enhancement training (PET) for parents with children diagnosed with Attention Deficit-/Hyperactivity Disorder (ADHD) who are already medicated with methylphenidate.

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The Effects of Long-acting Methylphenidate on Academic Activity and Related Constructs in Children with ADHD: A Randomised Placebo Controlled Trial

Clinical Trials Register.eu (Mar 2012)

The primary objective of this study is to explore the relationship between MPH and academic activity and the mediating roles of ADHD behaviours, cognitive deficits and motivational deficits in this relationship. Therefore, the direct effects of MPH on ADHD behaviours, cognitive deficits and motivational deficits are taken into account. In particular, evidence on the effects of MPH on motivational deficits in ADHD is scarce. It is hypothesized that treatment with MPH results in increased academic activity as compared to placebo control. If MPH improves academic activity, comparisons with the control group will be made to see if academic activity in children with ADHD normalises when treated with MPH.

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Adults With Attention Deficit Hyperactivity Disorder (ADHD): Validation of a Clinical Interview and Screening Instruments in French

Clinicaltrials.gov (Jan 2012)

ADHD is a neurodevelopmental disorder that affects about 5% of school-age children and 3.5% of adults worldwide. This condition is under-recognised in France and other European countries and, therefore, under-diagnosed. As part of the European Network for Adult ADHD, the investigators translated into French a structure interview called the Diagnostic Interview for Adult ADHD (DIVA). The investigators also translated rating scales such as the ASRS and the WURS. Validation studies are rare in France. The aim of this study is to include two groups of 50 adults whether they have or not ADHD with respect of Diagnostic and Statistical Manual - Revision 4(DSM-IV) criteria as implemented in the DIVA (i.e. actual at adulthood and past in childhood). Subjects have to fill out a booklet of questionnaires including the WHO's Adult ADHD Symptom Rating Scale (ASRS) (screening tool for actual diagnosis) and the Wender Utah Rating Scale (WURS, a screening tool for ADHD in childhood with respect of the Utah criteria). The investigator will be able to compare the actual criteria for ADHD between the ASRS and the DIVA, and the past criteria for ADHD between the WURS and the DIVA. Finally, an estimate of the prevalence of ADHD in adults will be computed.

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A Phase 3, Open-label, Multicentre, Protocol to Provide Access to Guanfacine Hydrochloride Extended Release for European Subjects with Attention-deficit/Hyperactivity Disorder (ADHD) who Participated in Study SPD503-315 or SPD503-316

Clinical Trials Register.eu (Nov 2011)

The primary objective of this study is to evaluate the long term saftey of SPD503.

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International Study to Predict Optimized Treatment - in Attention-Deficit and Hyperactivity Disorder

Clinical Trials Register.eu (Nov 2011)

The primary objectives of the iSPOT-A trial are to use Brain Resource's standardized 'Integrative Neuroscience' test batteries to 1) Identify objective markers of ADHD compared with healthy controls, using cognitive, brain and genetic markers

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Investigating Cognitive Behavioral Therapy in Patients With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders

Clinicaltrials.gov (Sep 2011)

The purpose of this study is to determine if cognitive behavioral therapy is effective in treating ADHD symptoms in patients with substance use disorders and comorbid ADHD.

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A 6-month, open-label extension to a 40-week, randomized, double-blind, placebo-controlled, multicenter efficacy and safety study of Ritalin® LA in the treatment of adult patients with childhood-onset ADHD

Clinical Trials Register.eu (May 2011)

To evaluate the long-term safety of Ritalin LA administered once daily for six months during open-label treatment in adults with ADHD.

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Toolkit for School Behavior Modification in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

Clinicaltrials.gov (Apr 2011)

The purpose of this study is to examine the efficacy of the ADHD-Toolkit (a toolkit for school behaviour modification in primary school children with ADHD-behaviours) in terms of general improvement in ADHD symptoms, specific targeted school-related problem behaviours, other disruptive behaviour disorder symptoms, teacher attitudes towards ADHD, teacher-child relationship and child self-esteem.

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A randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of Ritalin® LA in adult patients with childhood-onset ADHD

Clinical Trials Register.eu (Nov 2010)

Main objectives of the trial are; To confirm the clinically effective dose range of Ritalin LA in adults with childhood onset ADHD as measured by the change from Baseline to the end of a 9-week, fixed-dose treatment period in DSM-IV Attention-Deficit/Hyperactive Disorder Rating Scale (DSM-IV ADHD RS) total score. To evaluate improvement in functional impairment will be measured by the change from baseline in total score on the Sheehan Disability (SDS) is a self-rating scale designed to assess the functional impairment of patients with ADHD at the end of a 9-week fixed-dose treatment period. To evaluate the maintenance of effect of Ritalin LA in adults with childhood onset ADHD as measured by the percentage of Ritalin LA vs. placebo treatment failures at the end of a 6-month treatment withdrawal period. To evaluate the safety of Ritalin LA in adults with childhood onset ADHD as measured by the frequency of AEs, the results of laboratory tests, and the measurement of vital signs and ECGs.

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Effects of methylphenidate on the development of the dopaminergic system in the brain

Clinical Trials Register.eu (Nov 2010)

To report on the age-dependency of the effect(s) of MPH treatment on the outgrowth of the DA system using state-of-the-art Magnetic Resonance Imaging (MRI) techniques

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A Phase 4, Open-label, Multicentre, 2-Year Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents Aged 6-17 Years with Attention-Deficit/Hyperactivity Disorder (ADHD)

Clinical Trials Register.eu (Oct 2010)

To evaluate the long-term safety of SPD489 administered as a daily morning dose (30, 50, and 70mg) in the treatment of children and adolescents (6-17 years of age inclusive at the time of consent in this study or a previous SPD489 study (SPD489-317, SPD489-325, or SPD489-326) diagnosed with moderately to severely symptomatic ADHD.

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A Phase 3, Randomised, Double-blind, Multicentre, Parallel-group, Placebo- and Active-reference, Dose-optimisation Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents aged 6-17 years with Attention-Deficit/Hyperactivity Disorder

Clinical Trials Register.eu (Oct 2010)

The primary efficacy analysis will be performed on the change from baseline for the ADHD-RS-IV total score at Visit 15 using Last-Observation-Carried Forward (LOCF) methodology, for all subjects randomised and receiving study drug. The mean change from baseline will be compared between treatments using an Analysis of Covariance (ANCOVA) model. The primary treatment comparison is SPD503 versus placebo. The ANCOVA model will include treatment group (the effect of interest), the corresponding baseline score (the covariate), and the blocking factors age group (6-12 years or 13-17 years) and country. The null hypothesis states that there is no difference between SPD503 and placebo, with the 2-sided alternative of a non-zero difference between groups.

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A Phase 3, Double-blind, Placebo-controlled, Multicentre, Randomised withdrawal, Long-term Maintenance of Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 With Attention deficit/Hyperactivity Disorder

Clinical Trials Register.eu (Aug 2010)

The primary efficacy outcome for each subject is treatment failure during the double-blind randomised-withdrawal phase (Phase 2). The primary efficacy analysis will compare treatment failure rates between treatments (SPD503 and placebo) for all subjects who enter Phase 2 using a Cochran-Mantel-Haenszel (CMH) test stratified by age group and country. Subjects who discontinue for any reason during the randomised-withdrawal phase will be classed as treatment failures for the primary analysis. The null hypothesis states that there is no difference in treatment failure rate between SPD503 and placebo, with the 2-sided alternative of a non-zero difference between groups.

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Attention Deficit Hyperactivity Disorder (ADHD) and opioid maintenance therapy. A randomized, placebo-controlled study of the efficacy of atomoxetine for treating adult ADHD in patients receiving opioid maintenance therapy

Clinical Trials Register.eu (Jul 2010)

To estimate the efficacy of atomoxetine when treating ADHD in patients with comorbid opioid dependence.

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Evaluation of an Intervention for Improving Community-based Pediatric Attention-Deficit Hyperactivity Disorder (ADHD) Care

Clinicaltrials.gov (Jun 2010)

Evaluation of an Intervention for Improving Community-based Pediatric ADHD Care

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A Single Centre, Open-Label, Randomised Multi-Dose Study to Assess Changes in the Brain Metabolism of Juvenile ADHD Patients After Thirteen Weeks of Daily Intake of 4 g Superba Krill Oil or 4 g omega-3 Enriched Fish Oil

Clinical Trials Register.eu (May 2010)

To evaluate changes in the brain metabolism of juvenile ADHD patients after thirteen weeks of daily doses of 4 g Superba krill oil or 4 g omega-3 enriched fish oil

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ADHD - Voice Analysis, Vocal Acoustic Biomarkers in Attention Deficit Hyperactivity Disorder

Clinicaltrials.gov (Apr 2010)

The purpose of this study is to detect specific vocal acoustic patterns in the voice of attention deficit hyperactivity disorder (ADHD) patients.

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The effectiveness of Parent-Child Interaction Therapy versus methylphenidate in preschool children with ADHD and disruptive behavior problems with insufficient improvement through Parent Management Training.

Clinical Trials Register.eu (Mar 2010)

The primary aim of our study will be to investigate the effectiveness of PCIT in comparison with methylphenidate in children with ADHD and disruptive behavior problems aged 2;6 till 6 years who have not responded sufficiently to previously offered PMT.

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A Phase 3b, Double-blind, Randomised, Active-controlled, Parallel-group Study to Compare the Time to Response of Lisdexamfetamine Dimesylate to Atomoxetine Hydrochloride in Children and Adolescents aged 6-17 years with Attention Deficit/Hyperactivity Disorder (ADHD) Who Have Had an Inadequate Response to Methylphenidate Therapy.

Clinical Trials Register.eu (Jul 2009)

The primary objective of this study is to compare the time to response of lisdexamfetamine dimesylate (SPD489) with that of atomoxetine hydrochloride (STRATTERA) in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate (MPH) treatment where inadequate response includes, but is not limited to, the presence of some residual symptoms, inadequate duration of action and/or variability of symptom control, and/or Investigator feels that the subject may derive benefit from an alternative treatment to MPH therapy. The primary efficacy measure is time to response; where individual subject response is assessed using the Clinical Global Impressions – Global Improvement (CGI-I) Scale.

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Why methylphenidate is not successful in cocaine-dependent ADHD patients: a SPECT study comparing DAT before and after methylphenidate treatment in ADHD patients with and without cocaine dependence

Clinical Trials Register.eu (May 2009)

To determine why methylphenidate is not successful in cocaine-dependent ADHD patients, using SPECT to comparing DAT before and after methylphenidate treatment in ADHD patients with and without cocaine dependence

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Neurocognitive testing in children with ADHD

Clinical Trials Register.eu (Jun 2008)

Main objectives of the trial are; 1. to measure the effects of methylphenidate using the Neurocart test battery, to establish if these effects can be differentiated from placebo and to determine circadian variation in effect, 2. to describe the drug concentrations of methylphenidate in saliva, 3. to describe the PK/PD relationship using the obtained saliva samples, 4. to describe cardiovascular effects of methylphenidate (blood pressure and heart rate); 5. to evaluate clinical treatment effect during the trial, 6. to evaluate how children have experienced trial participation.

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A Phase III, Open-Label, Extension, Multicentre, Safety Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 with Attention-Deficit/Hyperactivity Disorder (ADHD)

Clinical Trials Register.eu (May 2008)

The primary objective of this study is to evaluate the long-term safety of LDX administered as a daily morning dose (30, 50, and 70mg/day) in the treatment of children and adolescents (6 -17 years of age inclusive at the time of consent for the antecedent study, SPD489-325) diagnosed with moderately symptomatic ADHD. The evaluation of safety will be based on the occurrence of treatment-emergent adverse events (TEAEs), specific evaluation of blood pressure and pulse, electrocardiogram (ECG) results, clinical laboratory test results, and physical examination findings.

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Influence of methylphenidate on sleep and circadian rhythm in children with Attention-Deficit/Hyperactivity Disorder (ADHD)

Clinical Trials Register.eu (Nov 2007)

Determine the influence of methylphenidate treatment on sleep-wake rhythm and endogenous melatonin rhythm in children with ADHD.

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A Randomized, Controlled, Open-Label Study of the Long-Term Impact on Functioning using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Treatment-Naïve Children and Adolescents. (ADHD-LIFE Study)

Clinical Trials Register.eu (Feb 2007)

The primary objective is to test the hypothesis that atomoxetine given at individually titrated doses for 6 months is superior to other early standard therapy in improving quality of life as measured by the mean change in the achievement domain of the Child Health and Illness Profile – Child Edition, Parent Report Form (CHIP-CE PRF), in pharmacologically naïve children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).

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Omega-3 Fatty Acids Supplementation for Adolescent Boys with Attention Deficit Hyperactivity Disorder : a double-blind, randomized controlled trial

Clinical Trials Register.eu (Apr 2006)

ADHD symptoms are often carried through to the adolescent period and long-term intervention is often needed. Patients and their parents often choose alternative treatments for ADHD. Omega-3 fatty acids supplementation is one popular alternative treatment, and relatively safe, but the effectiveness has not been assessed enough . This study aims to evaluate whether EFA supplementation improves ADHD symptoms in ADHD male adolescents.

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The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk, and Nut Allergy in Adults

Clinicaltrials.gov (Mar 2013)

In Finland, the estimated prevalence of physician-diagnosed food allergy in 1-4 year old children is 9%, and the most common allergen is milk. The overall food allergy has been reported to be 3.7%. Hen's egg allergy is among the most common food allergies in childhood. In addition, it predicts later development of allergic disease such as asthma. Most of the egg and milk allergy is transient and disappears in childhood. Currently, the standard of care for food allergy includes strict allergen avoidance. However, oral immunotherapy has been under investigation in children milk, egg, and wheat allergy. Previously, induction of clinical egg tolerance has been reported with egg oral immunotherapy in children aged from 3 to 13 years. In adults, strict avoidance is still the standard care but there is also growing interest in treatment of severe food allergy with oral immunotherapy or anti-IgE. The investigators aim to analyse the results of per oral immunotherapy treatment in severe IgE-mediated egg, milk, and nut allergy in adults. Could severe egg, milk and nut allergy be treated with oral immunotherapy treatment in stead of total allergen avoidance and could desensitization thus be achieved?

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Application of FSME-Immun® and Epaxal® in allergic patients

Clinical Trials Register.eu (Jan 2013)

To assess the humoral immunity, based on TBE Neutralisationstest-Titers one month +/- 7 days after booster

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Evaluation of the Sphingolipid Metabolite S1P as a Novel Biomarker in Food Allergy

Clinicaltrials.gov (Jan 2013)

Food allergies represent an increasing health concern in the industrialized countries and especially affect pediatric patients. In this population adverse reactions against food compounds can lead to anaphylactic reactions. Despite substantial research efforts, clinical markers predicting disease severity and symptoms are missing to date. Recent studies have revealed that sphingolipids, especially sphingosine-1-phosphate (S1P), play an essential role in allergy. It was reported that asthmatic patients have higher S1P levels in bronchiallavage fluids after allergen challenge. First experimental studies revealed a correlation of S1P and the outcome of anaphylaxis. Furthermore, we have shown in our recent mouse study that S1P homeostasis is pivotal for food allergy induction and effector cell response. Therefore, it is the aim of the presented pilot project to evaluate whether S1P serum titers are altered in food allergic children and if the S1P levels correlate with the outcome of anaphylaxis during double blind placebo controlled food challenges (DBPCFCs).

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Tree Nuts Allergies: Does a Single Nut Allergy Necessitate the Dietary Eviction of Other Tree Nuts? (ProNut)

Clinicaltrials.gov (Dec 2012)

The aim of this study is to identify, based on standardized food provocation tests, which nuts allergic patients need a selective, or a complete dietary eviction of all kind of nuts (nuts being defined as peanut, all tree nuts, pine nut and sesame). The investigators postulate that predictive factors of multiple nut allergy are high specific immunoglobulin E level, positive skin tests and/or clinical markers, such as atopic dermatitis, presence of other food allergies or a history of a severe previous reaction

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Prevalence of Food Allergies to Proteins From Different Legumes

Clinicaltrials.gov (Nov 2012)

The objective of the study is to assess the prevalence of a sensitization to proteins from legumes by skin prick test using commercial extracts (peanut, soy, and pea) and raw material (lupin) in atopic and healthy subjects.

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In-vivo biological standardization of Dermatophagoides, Betulaceae and Graminaceae extracts for the determination of the biological activity in HEP units

Clinical Trials Register.eu (Oct 2012)

Determination of the biological activity of allergenic extracts of Dermatophagoides, Betulaceae and Graminaceae in HEP units (histamine equivalent prick) in order to define an in-house reference preparation (IHRP).

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The effect of BM32, a recombinant hypoallergenic vaccine for immunotherapy of grass pollen allergy, on immunoglobulin levels in nasal secretions of patients suffering from seasonal allergic rhinitis

Clinical Trials Register.eu (Oct 2012)

To evaluate the effect of immunotherapy with the recombinant hypoallergenic vaccine, BM32, compared to placebo, on allergen-specific Ig levels in nasal secretion during 2 consecutive treatment years.

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Pilot study to downregulate allergic responses in adults with allergic rhinoconjunctivitis by using three intralymphatic injections of grass or birch allergen one month in between during the non-seasonal period.

Clinical Trials Register.eu (Oct 2012)

Effect on subjective symptoms following conjunctival allergen provocation before treatment compared to two months after the end of the first season.

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Efficacy of gencydo nasal spray on early nasal response after allergen exposition in patients with grass pollen allergy: a randomized, placebo controlled cross over study

Clinical Trials Register.eu (Aug 2012)

Clinical efficacy of Gencydo nasal spray on early allergic response to grass pollen in patients with grass pollen allergy

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Biological standardization of Chenopodium album allergen extract to determine the biological activity in HEP units.

Clinical Trials Register.eu (Aug 2012)

The primary objective is to assess the concentration of Chenopodium album allergen extract that elicits a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.

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A multicentre, double-blind, placebo-controlled, randomized trial to assess the efficacy and tolerability of two dosing regimens of AllerT, a combination of contiguous overlapping peptides derived from Bet v 1, in adult subjects allergic to birch pollen

Clinical Trials Register.eu (Aug 2012)

To demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season

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A Randomised, Double-blind, Single-centre, Controlled Trial of Low Dose Intradermal Allergen Immunotherapy in Adults with Seasonal Allergic Rhinitis

Clinical Trials Register.eu (Jul 2012)

The primary objective is to determine if pre-seasonal low dose intradermal grass pollen allergen immunotherapy (either 7 or 8 two-weekly injections of 10 Biological Units (33.333 SQ-U)) reduces symptoms and requirements for anti-allergic drugs in seasonal allergic rhinitis during the 2013 grass pollen season compared to the control intervention (histamine only).

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Biological standardization of allergen extracts of pollen of Artemisa vulgaris and Platanus acerifolia and the acarus Dermatophagoides farinae in patients sensitized to them.

Clinical Trials Register.eu (Jun 2012)

In-vivo determination of the biological activity of pollen extracts of Artemisa vulgaris, Platanus acerifoia and Dermatophagoides farinae.

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A randomized, double-blind, placebo-controlled study to determine safety, tolerability and the optimal effective dose of SUBLIVAC FIX Birch in patients with allergic rhinitis/rhinoconjunctivitis caused by birch pollen

Clinical Trials Register.eu (Apr 2012)

Determination of the optimal effective dose of SUBLIVAC FIX Birch (SB) based on reduction of upper airways reactivity assessed by TNPT after 5 months of treatment with different dosages of SB compared to placebo. Coprimary objective: Difference in proportions of patients not reaching maintenance dose within 10 days due to related AEs of different dosages of SB compared to placebo.

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Phase II study on the safety and efficacy of BM32, a recombinant hypoallergenic vaccine for immunotherapy of grass pollen allergy

Clinical Trials Register.eu (Feb 2012)

To assess the sustained clinical effect of BM32 during 2 consecutive treatment years compared to placebo. The clinical effect of 2 different dose levels of BM32 is evaluated by a combined Symptom-Medication-Score (SMS) which is recorded during the peak of the grass pollen season of each treatment year.

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Mechanistic study assessing the immunological response of subjects after treatment with different formulations of sublingual immunotherapy.

Clinical Trials Register.eu (Jan 2012)

To evaluate the immunological response in subjects with grass pollen induced allergic rhinoconjunctivitis after 8 weeks of once daily dosing with sublingual immunotherapy, either Alutard SQ Phleum pratense, 25,000 SQ-U, ALK Grass tablet Phleum pratense 25,000 SQ-T, or Aquagen Phleum pratense, 25,000 SQ-U.

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A double blind placebo controlled randomised trial to study the effects of birch pollen specific immunotherapy (BP-SIT) on the symptoms of the oral allergy syndrome in adult patients.

Clinical Trials Register.eu (Oct 2011)

Does immunotherapy (the process of giving small but increasing doses of birch pollen as injections under the skin) improve symptoms of mouth and throat itch, irritation and swelling on eating apples in patients with oral allergy syndrome?

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Efficacy of ALK house dust mite allergy immunotherapy tablet in subjects with house dust mite induced asthma.

Clinical Trials Register.eu (Jun 2010)

The primary objective of the trial is to evaluate the efficacy of the the house dust mite Allergy Immunotherapy Tablet (6 DU and 12 DU) given once daily compared to placebo in subjects with house dust mite induced asthma, as measured by reducing the risk for an asthma exacerbation.

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Sensory Support Care for Elderly Patients Suffering From Alzheimer'S-type Neurodegenerative Disease (SensiCare)

Clinicaltrials.gov (Mar 2013)

The main objective of this study is to evaluate the effect of 3 months of "Snoezelen-type" multi-sensory care sessions on NeuroPsychiatric Inventory Questionnaire (NPI-Q) scores for patients with Alzheimer's-type neurodegenerative disease.

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Early Diagnosis of Alzheimer-like Dementia: Benefit of MRI and PET Imaging

Clinicaltrials.gov (Mar 2013)

The physio-pathology of Alzheimer's disease (AD) remains unknown and there is no cure. Thus, the search for objective markers of preclinical first signs of cognitive impairment, is currently a major public health issue. Early detection of the disease is a major challenge to hope to slow or even stop the neurodegenerative process before the stage of dementia. In AD the investigators observe: A reduction in the volume of brain hippocampi associated with an alteration of the diffusion of water molecules in the white matter. A structural brain degeneration coupled with a decrease in cerebral glucose metabolism. Recent publications show that cerebrospinal fluid (CSF)flow is also altered, probably due to dysfunction of the choroid plexus. Hence the potential interest to study is, in addition to conventional imaging, the imaging of CSF dynamics and choroid plexus metabolism. In that aim,the investigators use two imaging modalities: Magnetic resonance imaging (MRI) is used to assess blood and CSF flow in the brain Positron emission tomography (PET) is used to assess glucose metabolism in grey/white matter and also in choroid plexus. The investigators expect that, because of choroid plexus atrophy in AD, CSF flow would be altered as well as glucose metabolism dynamic in choroid plexus.

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Impact of Therapeutic Educational Programme on the Alzheimer's Disease Affected Patient's Quality of Life (THERAD)

Clinicaltrials.gov (Feb 2013)

Therapeutic education expands in Alzheimer's Disease management in France. Several studies revealed a positive impact on caregiver's burden and/or quality of life. The purpose of this study, is to determine whether a therapeutic educational programme for both AD patients and primary caregivers, in community dwelling, improves patient's quality of life.

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Central and Systemic Inflammation in Alzheimer's Disease (IMABio3)

Clinicaltrials.gov (Jan 2013)

The main objective of this study is to investigate the central and peripheral inflammatory, as well as the spontaneous Aβ-specific, immune responses at the asymptomatic stage and early stages of AD by combining molecular imaging techniques with blood biomarker analyses. The early and preclinical stages of AD will be studied in the relatives of patients with PSEN1, PSEN2 or APP mutations that are at-risk (50%) to be mutation carriers. This study will evaluate the contribution of Inflammatory and immune anti-Aβ responses (I2ARs) in AD progression. Inclusion of sporadic and familial forms of AD will aid in studying the chronology of pathological events. Clinical follow-ups will be conducted annually for two years and will include an MRI and a blood draw on the last visit. We expect I2ARs to appear in the early stages of the disease and to constitute new prognostic factors. I2ARs could also become therapeutic markers for the assessment of novel anti-amyloid treatments and may offer new insights to the development of Aβ-specific immunotherapy strategies.

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A Randomised, Placebo-Controlled, Parellel-Group, Double-Blind Efficacy and Safety Trial of MK-8931 in Subjects with Mild to Moderate Alzheimer's Disease

Clinical Trials Register.eu (Jan 2013)

To assess the efficacy of two doses of MK-8931 on cognition in sugjects with mild to moderate AD To assess the efficacy of two doses of MK8931 on functional ability in activities of daily living in subjects with mild to moderate AD To assess the safety and tolerability of threee doses of MK-8931 in the treatment of subjects with mild to moderate AD

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A randomized, controlled, parallel group, double-blind, multi-centre, phase IIb study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations of patients who participated in the AFFITOPE® AD02 phase II study AFF006.

Clinical Trials Register.eu (Jan 2013)

To assess the longterm safety and tolerability of continued AFFITOPE® AD02 administrations following a predefined vaccination schedule (boosts at regular intervals after priming) over a total period of 37 months (includes the 18 months of the preceding AFF006 study). To assess the clinical activity (parameters for cognition and function) of vaccination with AFFITOPE® AD02 when extending the vaccination schedule applied within the preceding phase II study AFF006 by boosts at regular intervals (comparison to previous placebo patients now being vaccinated with verum).

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A European multicenre double-blind placebo controlled phase III trial of nilvadipine in mild to moderate Alzheimer's disease.

Clinical Trials Register.eu (Nov 2012)

To investigate the efficacy of Nilvadipine as a disease course modifying treatment for mild to moderate AD in a phase III double-blind placebo-controlled study. To investigate the safety profile of Nilvadipine in patients with mild to moderate AD.

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Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 18-Month Safety and Efficacy Study of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Mild Alzheimer’s Disease

Clinical Trials Register.eu (Nov 2012)

1. To demonstrate the clinical efficacy of leuco-methylthioninium bis(hydromethanesulfonate) (also known as LMTM, TRx0237) in mild Alzheimer’s disease as assessed by change from baseline on: • Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-cog11) • Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (ADCS-CGIC) - independently rated 2. To evaluate the effect of LMTM on Alzheimer’s disease modification as evidenced by reduction in decline in glucose uptake in the temporal lobe on 18F-flurodeoxyglucose positron emission tomography (FDG-PET) / computerized tomography (CT) imaging 3. To assess the safety and tolerability of LMTM 200 mg/day given for up to 78 weeks

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Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Month Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Mild to Moderate Alzheimer's Disease

Clinical Trials Register.eu (Nov 2012)

1. To demonstrate the clinical efficacy of at least one dose level of TRx0237 in mild to moderate Alzheimer’s disease as assessed by change from baseline on: • Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-cog11) • Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (ADCS-CGIC) - independently rated 2. To determine the safety and tolerability of TRx0237 150 and 250 mg/day

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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT 126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

Clinical Trials Register.eu (Sep 2012)

The objective of this study is to evaluate the efficacy and safety of two doses of ABT-126 in subjects with mild-to-moderate Alzheimer's disease (AD) taking doses of AChEIs

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A multicenter, open-label, long-term safety extension of phase II studies ABE4869G and ABE4955G in patients with mild to moderate alzheimer’s disease

Clinical Trials Register.eu (Sep 2012)

To assess the long-term safety and tolerability of crenezumab administered subcutaneously (SC) every 2 weeks (q2w) or intravenously (IV) every 4 weeks (q4w), in eligible patients with Alzheimer’s disease who participated in Study ABE4869g or ABE4955g and completed the Week 73 study visit, including brain MRI.

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Efficacy and safety of 3 doses of S 38093 (2, 5 and 20 mg/day) versus placebo, in co-administration with donepezil (10 mg/day) in patients with moderate Alzheimer’s Disease. A 24-week international, multi-centre, randomised, double-blind, placebo-controlled phase IIb study.

Clinical Trials Register.eu (Jul 2012)

To assess the efficacy of 3 fixed doses of S 38093 (2, 5 and 20mg/ day) versus placebo, in co-administration with donepezil 10 mg/day, after 24 weeks of treatment, on cognitive performance measured with the ADAS-Cog 11-items in patients with moderate Alzheimers' Disease

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A Double-Blind, Placebo-Controlled, Randomised, 4-Week Safety and Tolerability Study of LMTM in Subjects with Mild to Moderate Alzheimer’s Disease on Pre-Existing Stable Acetylcholinesterase Inhibitor and/or Memantine Therapy

Clinical Trials Register.eu (Jun 2012)

To assess the safety and tolerability of leuco-methylthioninium bis(hydromethanesulfonate) (LMTM) 250 mg daily when co-administered with an acetylcholinesterase inhibitor (AChEI) and/or memantine to patients with mild to moderate Alzheimer’s disease. As exploratory objectives, markers of monoamine oxidase (MAO) inhibition will be assessed and blood samples collected for separate population pharmacokinetic analysis.

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Assessment of Safety, Tolerability, and Pharmacodynamic Effects of LY2886721 in Patients with Mild Cognitive Impairment Due to Alzheimer’s Disease or Mild Alzheimer's Disease

Clinical Trials Register.eu (Jun 2012)

The primary objective of this study is to assess the CSF PD effect of different LY2886721 doses in patients with MCI due to AD or mild AD compared to placebo, measured by change of CSF Aβ1-40 and Aβ1-42 concentrations from baseline to Week 12 and Week 26.

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Long-Term Safety and Tolerability of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: An Open-Label Extension Study for Subjects Completing Study M11-793

Clinical Trials Register.eu (Jun 2012)

Evaluate the long-term safety and tolerability of ABT-126 in subjects with mild-to-moderate Alzheimer's disease (AD) taking doses of AChEIs in a 28-week open-label extension of Study M11-793.

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Long-Term Safety and Tolerability of ABT-126 in Subjects with Mild-to-Moderate Alzheimer’s Disease: An Open-Label Extension Study for Subjects Completing Study M10-985.

Clinical Trials Register.eu (May 2012)

The objective of this study is to evaluate the long-term safety and tolerability of ABT-126 in subjects with mild-to-moderate AD in a 28-week, open-label extension of Study M10-985.

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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT 126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

Clinical Trials Register.eu (Mar 2012)

The objective of this study is to evaluate the efficacy and safety of two doses of ABT-126 in subjects with mild-to-moderate Alzheimer's disease (AD) taking doses of AChEIs.

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Efficacy and safety of delta-9-tetrahydrocannabinol (delta-THC) in pain and pain related behavioural disturbances in dementia

Clinical Trials Register.eu (Mar 2012)

The primary objective is to evaluate the efficacy of Namisol® on pain related behavioural disturbances, such as agitation, aggression and aberrant motor disturbances in patients with dementia, when added to an analgesic treatment with acetaminophen.

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Rationalisation of antipsychotic drug use in older people, using [18F]-Fallypride PET

Clinical Trials Register.eu (Feb 2012)

(i)To investigate differences in regional dopamine D2/3 receptor occupancy between Alzheimer's Disease, Schizophrenia Like Psychosis and Healthy Controls after 4 days treatment with amisulpride 50mg daily (ii)To investigate differences in the threshold of dopamine D2/3 receptor occupancy required for 25% symptom reduction and emergence of motor side effects in SLP and AD during 4-10 weeks treatment with amisulpride (50-200mg daily) (iii) To determine dose-response relationships (dose/plasma level/clinical outcome) in SLP and AD during dose-titration of amisulpride (50-200mg) over 4-10 weeks

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An open-label study to compare the prognostic value of (18F)Flutemetamol PET-imaging with longitudinal biomarker data in healthy volunteers and patients with mild cognitive impairment

Clinical Trials Register.eu (Jan 2012)

To examine the efficacy of raised [18F]Flutemetamol brain uptake for differentiating subjects with mild cognitive impairment (MCI), who subsequently will develop Alzheimer’s disease (AD), from patients with MCI who will be cognitively stable or develop other dementias than AD

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The ACER-study - the effects of galantamine on the variability and stability of walking among patients with Alzheimer's disease.

Clinical Trials Register.eu (Jan 2012)

The main objective of the present study is to examine the effects of treatment with galantamine among patients with AD on the variability and stability of walking (with and without dual-task), functional mobility, standing balance, and cognitive functions (e.g. attention and executive functions).

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A Randomized, Double-Blind, Placebo- and Active-Controlled Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects with Mild to Moderate Alzheimer's Disease

Clinical Trials Register.eu (Oct 2011)

Evaluate the dose-response relationship with respect to the efficacy of symptomatic treatment and safety of three doses of ABT-126 in subjects with mild to moderate AD. The primary efficacy measure is the Alzheimer's Disease Assessment Scale – cognitive subscale (ADAS-Cog)

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Efficacy and safety of 3 doses of S 38093 (2, 5 and 20 mg/day) versus placebo in patients with mild to moderate Alzheimer’s disease. A 24- week international, multi-centre, randomised, double-blind, placebo-controlled phase IIb study followed by a 24-week extension period

Clinical Trials Register.eu (Jul 2011)

Main objective of the trial to assess the efficacy of S 38093 versus placebo after 24 weeks of treatment, on cognitive performance measured with the ADAS-Cog 11-items in patients with mild to moderate Alzheimer's disease.

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Neurodegenerative Changes in Alzheimer’s Disease: Identifying potential effects of Victoza® on degenerative changes

Clinical Trials Register.eu (Jun 2011)

To examine the effect of a 6 month treatment course with Victoza, a GLP-1 receptor agonist, on intracerebral amyloid aggregations determined by Pittsburgh Compound B PET-scans.

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Safety and Efficacy Study of Ladostigil in Mild to Moderate Probable Alzheimer's Disease

Clinicaltrials.gov (May 2011)

For many, Alzheimer's disease is the number one medical issue facing our aging society. It is a late onset neurodegenerative disease, frequently under diagnosed, that impairs memory and cognitive performance. There are no known treatments that can either prevent or reverse its progression. Consequently, there still remains a need to evaluate treatments which can better stabilize the symptoms of this disease. These symptoms frequently include decreased functional capacity and negative psychological attributes (e,g, depression, anxiety) in association with the memory and cognition deficits. This current study is being done to assess an investigational compound that has been designed to not only improved the cognitive status of affected patients but to also better manage all symptoms. Hence, the ultimate goal is to provide patients with an improved quality of life by slowing the progression of this neurodegenerative disease

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A randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase II study to evaluate the efficacy and safety of MABT5102A in patients with mild to moderate alzheimer’s disease

Clinical Trials Register.eu (Jan 2011)

•To evaluate the efficacy of MABT5102A compared with placebo, when administered over 68 weeks to patients with mild to moderate AD, in inhibiting disease progression using the Alzheimer’s Disease Assessment Scale Cognitive Subscale (ADAS-Cog [12-item]) •To evaluate the safety and tolerability of MABT5102A compared with placebo when administered over 68 weeks to patients with mild to moderate AD

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Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients with Alzheimer’s Disease

Clinical Trials Register.eu (Dec 2010)

The primary objective of the study is to assess the safety of solanezumab in Alzheimer’s disease (AD) patients during 24 months of open-label treatment following completion of 18 months of treatment with solanezumab or placebo in a double-blind registration study (H8A-MC-LZAM [LZAM] or H8A-MC-LZAN [LZAN], “feeder studies”) through analysis of AEs, vital signs, laboratory evaluations, electrocardiograms (ECGs), and MRIs.

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A Clinical Trial of Exendin-4 for the Treatment of Alzheimer's Disease

Clinicaltrials.gov (Dec 2010)

To determine the safety and effectiveness of twice daily administration of Exendin-4 as a treatment for early-stage Alzheimer's disease or mild cognitive impairment.

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A Single-Arm Open-Label Multi-Center Study to Determine the Specificity of Flutemetamol (18F) Injection for Excluding the Presence of Brain Amyloid in Healthy Young Adult Subjects Aged 18 to 40

Clinical Trials Register.eu (Nov 2010)

To determine the overall specificity of Flutemetamol (18F) Injection for excluding the presence of brain amyloid based on the visual assessment of a positron emission tomography (PET) scan by independent blinded readers reviewing images from a population of healthy young adult subjects aged 18 to 40.

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Alzheimer's Disease Neuroimaging Initiative 2 (ADNI2)

Clinicaltrials.gov (Oct 2010)

The purpose of this study is to build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO (Grand Opportunity; a study funded through an NIH grant under the American Recovery and Reinvestment Act), to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). ADNI2 seeks to inform the neuroscience of AD. This information will aid in the early detection of AD, and in measuring the effectiveness of treatments in future clinical trials.

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A 6-month prospective, multi-center, double-blind, placebo-controlled, randomized, adaptive-trial-design study to evaluate the safety and efficacy of 80mg b.i.d. ladostigil in patients with mild to moderate probable Alzheimer’s Disease with a 6-month open label follow-up period

Clinical Trials Register.eu (Sep 2010)

To evaluate the efficacy of ladostigil (80mg b.i.d) administered for 26 weeks versus matched placebo and the safety of ladostigil (80mg b.i.d) following administration for up to 52 weeks - Alzheimer’s Disease Assessment Scale-Cognitive Subscale (Unmodified, 11 Item, total score = 70): (ADAS-Cog) - Safety evaluation: 26-week and 52-week assessment of safety and tolerability of ladostigil dosing.

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CONCERT PLUS: An Open-Label Extension of the CONCERT Protocol (DIM18) Evaluating Dimebon (Latrepirdine) in Patients with Alzheimer's Disease

Clinical Trials Register.eu (Jun 2010)

To evaluate the long-term safety and tolerability of dimebon (latrepirdine) in Alzheimer’s disease (AD) patients who have completed 52 weeks of blinded treatment in the DIM18 (CONCERT) protocol.

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A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Pharmacodynamic Effect of Single and Multiple Oral Doses of AZD1446/ Placebo and a Single Dose of Donepezil on Quantified Electroencephalography (qEEG) and Event-Related Potentials (ERP) in Patients with Mild-to-Moderate Alzheimer's Disease

Clinical Trials Register.eu (Feb 2010)

To evaluate the effect of single and multiple dosing of AZD1446 and a single dose of donepezil on Quantified electroencephalography (qEEG) and Event-related potentials (ERP) in patients with mild-to-moderate AD.

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A Phase 3 Extension, Multicenter, Double-blind, Parallel-Group, Long-term Safety and Tolerability Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer Disease Who Are Apolipoprotein E ε4 Noncarriers and Participated in Study 3133K1-3000-WW

Clinical Trials Register.eu (Nov 2009)

The primary objective of study 3133K1-3002-WW is to evaluate the long term safety and tolerability of intravenously administered bapineuzumab in subjects with Alzheimer Disease (AD) based on adverse events, scheduled vital signs, electrocardiogram parameters, clinical laboratory tests, brain MRI scans, physical and neurological examinations, and infusion site assessment. In addition, the studies will be continuously monitored by an independent safety monitoring committee.

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Clinical Trial of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia

Clinicaltrials.gov (Oct 2009)

To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia.

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Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION)

Clinicaltrials.gov (Jul 2009)

This study will assess the efficacy of a higher dose of rivastigmine patch (15 cm2) compared to a lower dose of the rivastigmine patch (5 cm2), in patients with severe dementia of the Alzheimer's type.

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Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease

Clinicaltrials.gov (Apr 2009)

The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment of Alzheimer's disease. CERE-110 is an experimental drug that is designed to help nerve cells in the brain function better. CERE-110 uses a virus to transfer a gene that makes Nerve Growth Factor (NGF), a protein that may make nerve cells in the brain healthier and protect them from dying. The virus used in CERE-110 does not cause disease in people. CERE-110 has been carefully studied in laboratory animals and is in the early stages of being tested in people.

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CONNECTION PLUS: An Open-Label Extension of the CONNECTION Protocol (DIM14) Evaluating Oral Dimebon in Patients with Alzheimer’s Disease

Clinical Trials Register.eu (Mar 2009)

To evaluate the long-term safety and tolerability of Dimebon in Alzheimer’s Disease (AD) patients who have successfully completed 26 weeks of blinded treatment in the CONNECTION protocol (DIM14).

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A randomised, double-blind, double-dummy, oral donepezil controlled study on the safety and efficacy of repeated monthly subcutaneaous injections of a sustained-release implant of ZT-1 in patients with moderate Alzheimer’s Disease (AD)

Clinical Trials Register.eu (Feb 2008)

The main objectives of this study are to assess the efficacy of the ZT-1 implant in improving cognitive function, behavioural and overall outcomes, compared to oral daily doses of donepezil and to assess the safety of the ZT-1 implant, compared to oral daily doses of donepezil.

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Open Label Study of the Effect of Daily Treatment with MPC-7869 in Subjects with Dementia of the Alzheimer’s Type

Clinical Trials Register.eu (Nov 2007)

Main objective of the trial is to evaluate the safety of long term treatment with MPC-7869

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A 52-week, multi-center, randomized, double-blind, placebo-controlled, parallel group study in patients with mild Alzheimer’s Disease (AD) to investigate the safety and tolerability of repeated subcutaneous injections of CAD106

Clinical Trials Register.eu (Sep 2007)

To evaluate the safety and tolerability of repeated subcutaneous (s.c.) injections of 150μg CAD106 in patients with mild AD over the 52 weeks of the study.

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An Open-Label Extension of the Phase III Study CL-758010 with Alzhemed™ in Patients with Alzheimer’s Disease.

Clinical Trials Register.eu (Mar 2007)

The primary objective of this open-label study is to evaluate the long-term safety of Alzhemed™ in patients with Alzheimer’s Disease (AD).

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A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of FG-4592 for the Treatment of Anemia in Chronic Kidney Disease Patients not on Dialysis

Clinical Trials Register.eu (Feb 2013)

To evaluate the efficacy of FG-4592 in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) subjects.

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Study of ACE-536 for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS)

Clinicaltrials.gov (Dec 2012)

The purpose of this study is to evaluate the effects of ACE-536 on anemia in patients with low or intermediate-1 risk MDS.

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A four-week, Phase IIa, randomized, active-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of switching subjects from a stable dose of recombinant human erythropoietin to GSK1278863 in hemodialysis-dependent subjects with anaemia associated with chronic kidney disease

Clinical Trials Register.eu (Oct 2012)

Estimate the relationship between dose of GSK1278863 and hemoglobin (Hgb) response following switching from a stable dose of rhEPO in subjects undergoing HDD.

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Study to Assess S303 RBCs and Evaluate Safety and Efficacy in Patients Requiring Transfusion Support of Acute Anemia

Clinicaltrials.gov (Oct 2012)

The clinical study will assess the in-vitro characteristics of red blood cells (RBCs) per the European Union (EU) criteria for leukocyte depleted RBCs in additive solution and evaluate the safety and efficacy of S-303 treated RBCs in a patient population requiring RBC transfusion support for acute anemia.

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A randomised double-blind controlled phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose with placebo in patients with anaemia undergoing major open abdominal surgery

Clinical Trials Register.eu (Sep 2012)

To determine if a single dose of intravenous iron given to patients with anaemia prior to major open abdominal surgery, reduces the need for peri-operative blood transfusion (the peri-operative period is defined as from randomisation to the trial until 30 days following operation)

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An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Darbepoetin alfa in Paediatric Subjects From Birth to Less than 1 Year of Age With Anemia due to Chronic Kidney Disease

Clinical Trials Register.eu (Sep 2012)

To evaluate the safety and tolerability of darbepoetin alfa following single 1.5 microgram/kg subcutaneous (SC) dose administration in paediatric subjects < 1 year of age with anaemia due to chronic kidney disease

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The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients – a pilot study

Clinical Trials Register.eu (Jan 2012)

To determine whether intravenous iron given in the first few days following hip fracture is effective in stimulating red cell production.

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Open label, single arm, multicenter study to evaluate the safety and immunogenicity of HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in pre-dialysis and dialysis patients

Clinical Trials Register.eu (Nov 2011)

To demonstrate the lack of immunogenicity of HX575 administered s.c. in the treatment of anemia associated with CKD

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An open label study to determine the efficacy of ferric carboxymaltose in preoperative colorectal cancer related anaemia, and to develop biomarkers to predict response to this treatment strategy

Clinical Trials Register.eu (Sep 2011)

The principal research question is can we reduce the need for peri-operative allogeneic blood transfusion in the treatment group (intravenous ferric carboxymaltose) compared to the control group (oral ferrous sulphate)?

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A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn’s Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2)

Clinical Trials Register.eu (May 2011)

To demonstrate the effectiveness of oral ST10-021 in the treatment of iron deficiency anaemia in patients with non-active Crohn's Disease where oral ferrous preparations have failed or cannot be used.

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A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1).

Clinical Trials Register.eu (May 2011)

To demonstrate the effectiveness of oral ST10-021 in the treatment of iron deficiency anaemia in patients with non-active ulcerative colitis where oral ferrous preparations have failed or cannot be used.

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An Open-label, Multi-Centre, Non-Randomised Extension Study to Assess the Ability to Maintain a Stable Haemoglobin and to Assess Safety of Iron Isomaltoside 1000 (Monofer®) in Subjects with Inflammatory Bowel Disease

Clinical Trials Register.eu (Apr 2011)

1. To assess the long term efficacy of iron isomaltoside 1000 (Monofer®) by means of the ability to maintain stable Hb (defined as Hb ≥ 12.0 g/dL) in subjects with Hb ≥ 12.0 g/dL at the Baseline of Extension Study. 2. To assess the ability to achieve stable Hb (Hb ≥ 12.0 g/dL) at Month 3 Visit of Extension Study, and then to maintain the stable Hb thereafter in subjects with Hb < 12.0 g/dL at Baseline of Extension Study.

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Eltrombopag for Moderate Aplastic Anemia

Clinicaltrials.gov (Apr 2011)

To evaluate the safety and effectiveness of eltrombopag in people with moderate aplastic anemia who need treatment for significantly low blood cell counts.

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Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients with Orthopaedic Surgery and High Risk of Blood Loss

Clinical Trials Register.eu (Mar 2011)

The main objective of this study is to evaluate the effect of the administration of ferric carboxymaltose on transfusion requirements (units of packed cells)

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A prospective open-label randomized study to determine the effects of intravenous Iron administration on markers of kidney injury in chronic kidney disease (CKD)

Clinical Trials Register.eu (Oct 2010)

To assess whether two preparations of intravenous iron therapy affect markers of kidney injury including NGAL levels in serum and urine as a result of intravenous Iron therapy in patients with chronic kidney disease (CKD). The primary objectives of this study are to: To assess the effects of two preparations of intravenous (IV) iron in a cohort of CKD patients with biochemical functional or absolute iron deficiency (ferritin level less than 200 g/l or/and transferrin saturation of <20%) on measures renal injury. To determine whether iron sucrose and iron dextran differ in their effects on markers of renal injury in comparison to baseline measures during the lead in period. To determine whether IVI iron leads to potential transient AKI from assessment of changes in markers of renal injury from baseline markers prior to iron administration.

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The effectiveness and tolerability of GlobiFer (haem iron) tablets compared to ferrous sulphate tablets in inflammatory bowel disease: a randomised-controlled trial.

Clinical Trials Register.eu (Mar 2010)

To test the hypothesis that Globifer Forte treatment leads to a better resolution of anaemia compared to ferrous sulphate in inflammatory bowel disease patients in 12 weeks.

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An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject® High- and Low-dosage Regimens) versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Subjects with Non-dialysis-dependent Chronic Kidney Disease

Clinical Trials Register.eu (Nov 2009)

To evaluate the long-term efficacy of FCM (using targeted ferritin levels to determine dosing) or oral iron to delay and/or reduce erythropoiesis stimulating agent (ESA) use and/or other anaemia management options in NDD-CKD subjects with iron deficiency anaemia (IDA).

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Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in End Stage Renal Disease (ESRD)

Clinicaltrials.gov (Nov 2009)

The investigators hypothesize that the post-hospitalized patient status is characterized by subacute and reversible metabolic and hematological changes that, if addressed and treated in a timely manner, would result in a reduced risk for repeat hospitalization. Consequently, a structured quality improvement program, focused on increasing adherence to company wide anemia management policies (ie hemoglobin monitoring within the first 3-5 days post-hospitalization, followed by an appropriate EPO dose modification within the 7 days post-hospitalization), will significantly decrease the risk of hospital re-admission in the 30 days after discharge.

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A phase III, randomized, comparative, open-label study of intravenous iron oligosaccharide (Monofer®) administered by infusions or repeated bolus injections in comparison with oral iron sulphate in inflammatory bowel disease subjects with iron deficiency anaemia

Clinical Trials Register.eu (Jul 2009)

To demonstrate that intravenous iron oligosaccharides is non-inferior to oral iron sulphate in reducing iron deficiency anaemia secondary to IBD, evaluated as the ability to increase haemoglobin (Hb).

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Tissue Sample Collection From Patients With Fanconi Anemia

Clinicaltrials.gov (May 2009)

This laboratory study is collecting and storing tumor tissue samples from patients with Fanconi anemia.

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Intravenous Iron: biomarkers and treatment strategies in anaemic Colorectal cancer patients.

Clinical Trials Register.eu (May 2009)

Does the use of intravenous iron provide a safe and effective treatment for anaemia in surgical patients and does the use of intravenous iron lead to a reduction in allogenic blood transfusion?

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A clinical open, randomised study of oral iron (Duroferon®) vs. intravenous iron (Ferinject®) for iron substitution in blood donors.

Clinical Trials Register.eu (Feb 2009)

To investigate whether there is a difference in the change of blood haemoglobin (Hb) levels between blood donors receiving intravenous iron (Ferinject®) vs. the Swedish standard iron substitution regimen of oral iron (Duroferon®) at visit 2, compared to baseline.

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A randomized, controlled, open-label, multi-centre, parallel-group study to assess all-cause mortality and cardiovascular morbidity in patients with chronic kidney disease on dialysis and those not on renal replacement therapy under treatment with MIRCERA® or reference ESAs.

Clinical Trials Register.eu (Oct 2008)

To demonstrate non-inferiority of MIRCERA® versus reference ESAs in terms of a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction (MI), stroke).

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Prospective Phase II Pilot study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin

Clinical Trials Register.eu (Oct 2007)

To assess the tolerability and efficacy of rabbit antithymocyte globulin (ATG, Thymoglobuline®) with Ciclosporin (CSA) in the first line treatment of patients with acquired severe aplastic anaemia (SAA), and patients with non-severe aplastic anaemia (NSAA) and who are transfusion dependent.

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The Effect of Treating Patients with Anaemia in Diabetic Nephropathy to different target haemoglobin levels with Epoetin Beta

Clinical Trials Register.eu (Nov 2006)

To determine whether treating patients with Anaemia and Diabetic Nephropathy with EPOETIN BETA to different target haemoglobin ranges has an effect on rate of deterioration of renal function, need for dialysis and death.

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Preoperative Patient Warming for Prevention of Perioperative Hypothermia in Major Abdominal Surgery (THER-6)

Clinicaltrials.gov (Feb 2013)

The study should evaluate how long patients undergoing major abdominal surgery under combined general/epidural anaesthesia have to be actively warmed preoperatively to prevent perioperative hypothermia and postoperative shivering. 99 patients will receive forced-air skin-surface warming for different duration. Body temperature will be measured at the tympanic membrane, in the urinary bladder and sublingually. Shivering will be graded by visual inspection. The investigators hypothesize that active warming before starting the epidural anaesthesia will decrease the incidence of perioperative hypothermia.

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Prediction of Hemodynamic Reactivity During Suspension Laryngoscopy Using Analgesia/Nociception Index (ANI)

Clinicaltrials.gov (Feb 2013)

The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the prediction of hemodynamic reactivity in adult patients undergoing suspension laryngoscopy on general anesthesia.

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Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture

Clinicaltrials.gov (Feb 2013)

There is a elevated risk of acute compartment syndrome (ACS) related to tibial shaft fractures due to oedema and reduced blood flow in traumatised tissues. This may lead to lack of oxygen and even necrosis. Symptoms of ACS are severe pain, hypoaesthesia, pain during flexion of the ankle and swollen leg in clinical examination. Paralysis and lack of distal pulses are late symptoms of ACS. Many experts think that effective relief of pain caused by regional anaesthesia (RA) may hide the symptoms of the ACS. This may be incorrect. The evidence of dangers related to RA is based on old patient-series and single case-reports. Some of these studies report the symptoms of ACS (hypaesthesia and even pain) being caused by RA. Majority of the conclusions in these studies cannot be confirmed by an expert of RA. It is also possible that there are more hemodynamic changes related to general anaesthesia (GA) which may predispose to ACS. There are no modern, randomized and controlled studies of the safety of RA in patients with tibial shaft fracture.

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Evaluation of Nexfin During Anesthesia and in Intensive Care (NexfinEval)

Clinicaltrials.gov (Aug 2012)

The purpose of this study is to compare the non invasive measurement of arterial pressure (Nexfin monitor)with the invasive measurement of arterial pressure (radial artery catheter) - during induction of general anesthesia, - during a leg raising test in the Intensive Care Unit

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Hypnosis and Closed-Loop Anesthesia System (LoopHypnosis)

Clinicaltrials.gov (Jul 2012)

Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what extent, hypnosis decreases propofol requirement to induce induction of general anesthesia. A particular aspect of this study is that induction is provided by a closed-loop system which delivers propofol according to bispectral index.

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Efficacy of Preemptive Volume Loading to Prevent Arterial Hypotension During Induction of General Anesthesia (NICOM-MAP)

Clinicaltrials.gov (May 2012)

Induction of general anesthesia induces frequently arterial hypotension. The short term goal of this study is to evaluate if preemptive volume loading prevents such complication.

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Improvement of Needle Visibility in Ultrasound Guided Regional Anaesthesia

Clinicaltrials.gov (Apr 2012)

Needle tip visualization, although fundamental to the safety and efficacy of ultrasound-guided regional anesthesia (UGRA), can be extremely challenging. This problem is most marked at steep insertion angles. Studies in patients with UGRA demonstrate that echogenic needle designs have the potential to offer improved visibility and accuracy. Our study pursues another approach. We use (for differentiation) echogenic nerve block needles with ANV®, a new SonoSite software-upgrade (Advanced Needle Visualization Technology®). We will compare UGRA with ANV® against standard UGRA without using this SonoSite software-upgrade. Patients undergoing femoral, supraclavicular or other nerve blocks as part of their routine anesthetic management are included. This work represents the first randomized controlled double blinded clinical trial of ANV® in patients undergoing UGRA. We hypothesize, that we can decrease the time without needle visualization (Loss of needle time in percentage of procedure time) during in-line regional anaesthesia. Furthermore we will record quality of visibility, duration of procedure and insertion angle of the needle.

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Comparison of Different Propofol Formulations With or Without Remifentanil (PropofolRemi)

Clinicaltrials.gov (Apr 2012)

The objective of this study is to evaluate the influence of different propofol formulations (plain or with remifentanil) on anesthetic induction. Propofol plain or with remifentanil is administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.

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Evaluation of Analgesia Nociception Index (ANI) During Propofol/Remifentanil and Sevoflurane/Remifentanil Anesthesia

Clinicaltrials.gov (Jan 2012)

The aim of this prospective randomized study was to evaluate the ability of the new Analgesia Nociception Index ANI, derived by heart rate variability, to detect painful stimulation during either propofol or sevoflurane anesthesia and changing remifentanil concentrations.

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General Anesthesia vs. Local Anesthesia in Stereotaxy (GALAXY)

Clinicaltrials.gov (Jan 2012)

Examination of stress level in general anesthesia in comparison to local anesthesia in stereotactic biopsy

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Succinylcholine or Rocuronium for Rigid Bronchoscopy Under General Anesthesia (Broncho-SR)

Clinicaltrials.gov (Jan 2012)

Myorelaxation is generally used as a part of general anesthesia for interventional rigid bronchoscopy. Succinylcholine is most often used because its short duration of action but rocuronium can be used since sugammadex permits a rapid and complete reversal of the neuromuscular block. The aim of ths study is to compare both agents.

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Thoraco-abdominal Volume Variations During Recovery From Total Intravenous Anesthesia Studied by Opto-electronic Plethysmography

Clinicaltrials.gov (Nov 2011)

The aim of this study is to examine chest wall volume changes monitored by opto-electronic plethysmography during recovery from anesthesia and early postoperative period.

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Street Fitness in Surgical Patients Undergoing General Anesthesia After Reversal of Neuromuscular Blockade (SFINX)

Clinicaltrials.gov (Oct 2011)

The main aim of the present study is to assess whether sugammadex has a positive effect on the post-operative alertness of the patients, to assess the nature, magnitude and the time of onset of this effect and if a clinically relevant effect has been observed to enable the sample size calculation for a formal well-powered efficacy study.

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Rebreathing of Carbon Dioxide With a Device Used for Giving Inhalational Anaesthesia

Clinicaltrials.gov (Apr 2011)

The anesthesia gas reflector (AnaConDa) is built on the adsorptive capacity of active carbon which also adsorbs carbon dioxide in exhaled air. Rebreathing of carbon dioxide thus occurs and must be compensated for by increased ventilation. This study aims at determining how much compensation must be given, based on the hypothesis that rebreathing depends on carbon dioxide level in blood and exhaled air.

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Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery

Clinicaltrials.gov (Feb 2011)

Xenon is a gaseous anaesthetic agent registered in several European countries. It has been administered safely during cardiac surgery in pilot studies. In animal studies, xenon decreases the size of experimental myocardial infarction. This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered before and after extracorporeal circulation. Propofol will be administered during extracorporeal circulation in the three groups of patients. The study will compare the postoperative myocardial damage observed 24 hours after surgery from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The main hypothesis is that the myocardial damage observed after xenon administration will not be superior to the damage observed after sevoflurane administration (non-inferiority). The second hypothesis is that the myocardial damage observed after xenon administration will be inferior to the damage observed after total intravenous anaesthesia.

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Lidocaine and Closed-Loop Anesthesia System (LoopLido)

Clinicaltrials.gov (Jun 2010)

The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.

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Factors Influencing Anesthetic Drug Requirement (PosoAnes)

Clinicaltrials.gov (May 2009)

The main objective of the study is to analyze the influence of several environmental (i.e., timing: seasonal, circadian) and demographic conditions (i.e., age, gender, menstrual cycle) on anesthetic drug requirements (hypnotic and opiate).

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Influence of Muscle Relaxation on a Closed-loop Anesthesia System (Drone-Curare)

Clinicaltrials.gov (Apr 2009)

Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning.

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Anesthesic Propofol and Remifentanil Requirements in Obese Patients (LoopObese)

Clinicaltrials.gov (Oct 2008)

Pharmacokinetic models for anesthetic agents are questionable. The objective of the study is to compare the propofol and remifentanil doses required to maintain the bispectral index in the range 40-60 in two groups of patients: obese patients and lean patients

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Atrial Fibrillation (AF) and Physical Exercise (EXAF)

Clinicaltrials.gov (Mar 2013)

To explore the role of alternative treatment strategies and to renew handling of cardiac arrhythmia, we have therefore set out to study the role of physical exercise in AF patients. Our specific study aims are to examine: - The effect of physical exercise on AF burden - The effect of physical exercise on the risk of cardiovascular hospitalization

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Satisfaction/Quality of Life With Rivaroxaban in SPAF (Stroke Prevention in Atrial Fibrillation) Indication (SAFARI)

Clinicaltrials.gov (Mar 2013)

National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues for stroke prevention in non valvular atrial fibrillation is associated with an improvement of the treatment satisfaction after 3 months. The treatment satisfaction will be measured by the Anti Clot Treatment Scale (ACTS) score.

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Canakinumab for the Prevention of Recurrences After Electrical Cardioversion: CONVERT-AF

Clinicaltrials.gov (Mar 2013)

The purpose of this study is to test the efficacy of a single injection of Canakinumab on AF recurrences within 6 months after electrical cardioversion in patients with persistent AF.

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Atrial Fibrillation/Sinus Rhythm Before and After Cardioversion

Clinicaltrials.gov (Jan 2013)

This study´s aim is to collect scientific data about patients with atrial inflammation by two principles of sensors measuring congestive heart failure.

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Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems (MATRIX)

Clinicaltrials.gov (Jan 2013)

This is an observational registry study aiming to collect data on efficacy and safety of the single chamber Biotronik DX system with enhanced atrial diagnostics. The minimal follow-up period is 24 months. All analyses on the data will be done post-hoc; the study does not intend to confirm any pre-specified hypotheses.

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Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment (STARLIGHT)

Clinicaltrials.gov (Jan 2013)

The purpose of the study is to gather electrophysiological data using a multi-electrode mapping catheter during a clinically indicated cardiac ablation procedure for the treatment of persistent atrial fibrillation.

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Dantrolene in catecholaminiergic polymorphic ventricular tachycardia

Clinical Trials Register.eu (Dec 2012)

The aim of this trial is to assess the antiarrhythmic effects of dantrolene

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Dabigatran and rivaroxaban: prediction of anticoagulant effect

Clinical Trials Register.eu (Jun 2012)

The aim of this study is to investigate the in-vivo variability of hemostasis between patients when treated with a direct thrombin inhibitor (Dabigatran) or a direct Factor Xa (FXa) inhibitor (Rivaroxaban) by measuring thrombin generation. In addition, we want to investigate whether there is a correlation between the in-vivo effect and ex- vivo effect in a patient by spiking blood of patients before treatment with rivaroxaban or the active metabolite of dabigatran.

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A Phase 2 Study to Assess the Antiarrhythmic and Symptomatic Effect of the Second Generation Antisense Oligonucleotide ISIS 329993 Targeting CRP in Patients with Paroxysmal Atrial Fibrillation

Clinical Trials Register.eu (May 2012)

To evaluate whether treatment with ISIS 329993 can reduce AF (Atrial Fibrillation) burden (percentage of time spent in AF as derived from continuous pacemaker monitoring) in subjects with paroxysmal AF.

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Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)

Clinical Trials Register.eu (Apr 2012)

The primary hypothesis of the CABANA trial is that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) is superior to current state-of-the-art medical therapy with either rate control or rhythm control drugs for reducing total mortality (primary endpoint) and decreasing the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest (key secondary endpoint) in patients with untreated or incompletely treated AF warranting therapy. It is anticipated that treatment with percutaneous left atrial catheter ablation will reduce mortality with ≥ 30% compared to drug therapy. All endpoints will be carefully assessed and analyzed on an intention to treat basis.

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A Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Once-Daily Oral Doses of 75 mg Azimilide Dihydrochloride on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients with an Implantable Cardioverter Defibrillator

Clinical Trials Register.eu (Jan 2012)

The primary objective of this study is to assess the impact of 75 mg azimilide versus placebo on the occurrence of unplanned (non-elective) cardiovascular hospitalizations, unplanned cardiovascular emergency department visits, or cardiovascular death in patients with an ICD. Analysis of efficacy will be done by comparing the effect of azimilide versus placebo on the time-to-first-occurrence of a qualifying event.

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A phase 2, proof of concept, randomised, placebo-controlled, parallel group study to evaluate the effect of ranolazine and dronedarone when given alone and in combination on atrial fibrillation burden in subjects with paroxysmal atrial fibrillation

Clinical Trials Register.eu (Dec 2011)

To evaluate the effect of ranolazine and of low dose dronedarone when given alone and in combination at different dose levels on AFB over 12 weeks of treatment. AFB is defined as the total time a subject is in atrial tachycardia/atrial fibrillation (AT/AF) expressed as a percentage of total recording time.

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Effects of acute and chronic oral administration of S 44121 versus placebo on cardiac arrhythmia during exercise testing in patients with catecholaminergic polymorphic ventricular tachycardia type 1 - A randomized, parallel-group, international multicentre study including a 8-week double-blind placebo controlled period followed by a 8-week single-blind period - Phase II exploratory study

Clinical Trials Register.eu (Dec 2011)

Evaluation of the effects on the occurrence of cardiac arrhythmia during standardized exercise tests (ETs)

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Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation

Clinical Trials Register.eu (Jun 2011)

To compare the time duration and the efficacy of cardioversion between the two rapid-acting antiarrhythmic drugs vernakalant and ibutilide in patients with recent-onset atrial fibrillation admitted to the emergency medicine ward of a tertiary care hospital.

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A Randomized, international, multi-center, open-label study to document optimal timing of initiation of dronedarone TreatmEnt after conversion with loading dose of aMIodarone in patients with perSistent Atrial Fibrillation requiring conversion of AF

Clinical Trials Register.eu (Apr 2010)

The primary objective of the study is to evaluate the rate of AF recurrences one month after randomization according to different timings of initiation of dronedarone.

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MEA115661: A multi-centre, open-label, long-term safety study of mepolizumab in asthmatic subjects who participated in the MEA115588 or MEA115575 trials.

Clinical Trials Register.eu (Feb 2013)

To describe the safety profile of mepolizumab in subjects receiving long-term treatment

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Acid-suppressing Drugs Pregnancy Asthma Offspring Study

Clinicaltrials.gov (Feb 2013)

The purpose of this study is - To estimate the association between prenatal exposure to proton pump inhibitors (PPIs) and the risk of asthma during childhood. - To estimate the association between prenatal exposure to H2-receptor antagonists (H2RAs) and the risk of asthma during childhood.

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Compare the Effects of Seretide® Evohaler and a Generic Salmeterol/Fluticasone Hydrofluoroalkane (HFA) Pressurized Metered-dose Inhaler (pMDI) on Functional Respiratory Imaging Parameters in Asthmatic Patients

Clinicaltrials.gov (Jan 2013)

The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)

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Bicentric Prospective Study, Evaluating Bronchial THERMOPLASTY in a Patient Presenting Severe Uncontrolled Asthma (ASMATHERM)

Clinicaltrials.gov (Jan 2013)

To determine, from patients presenting severe asthma and an increase in bronchial smooth muscle mass, those who would be the best candidates for bronchial THERMOPLASTY. THERMOPLASTY should improve control of the asthma, reduce day-to-day symptoms and severe exacerbations, and improve respiratory function

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Control and Burden of Asthma and Rhinitis (ICAR)

Clinicaltrials.gov (Jan 2013)

An observational cross-sectional study will include 750 individuals of all ages, divided in 4 groups: 1) Patients with a self-reported diagnosis of asthma alone (n=150), 2) Patients with a self-reported diagnosis of rhinitis alone (n=150), 3) Patients with a self-reported diagnosis of asthma and rhinitis (n=150) and 4) Patients with no history of respiratory symptoms or diseases (n=300)

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Optimization of Inhaled Corticosteroid Treatment in Adult Patients With Asthma Guided by Exhaled NO Measurement at Home (OCTAGEN)

Clinicaltrials.gov (Jan 2013)

To compare the clinical outcome (effectiveness) of single inhaled corticosteroid (ICS) controller treatment guided by exhaled NO measurement made at home with usual care asthma management with regard to asthma control (primary outcome), asthma-related quality of life, lung function, airway inflammation, medication use, and asthma events. To understand changes in patient behaviour triggered by daily FENO measurement at home, for example treatment adherence and voluntary allergen exposure.

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A 26 week, randomized, double-blind, parallel-group, active controlled, multicenter, multinational safety study evaluating the risk of serious asthma-related events during treatment with Symbicort®, a fixed combination of inhaled corticosteroid (ICS) (budesonide) and a long acting β2-agonist (LABA) (formoterol) as compared to treatment with ICS (budesonide) alone in adult and adolescent (≥12 years of age) patients with asthma.

Clinical Trials Register.eu (Jan 2013)

To evaluate the risk of serious asthma related events during treatment with Symbicort pMDI or budesonide pMDI alone (asthma-related deaths, intubations, hospitalizations).

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Roflumilast Plus Montelukast in Adults With Severe Asthma

Clinicaltrials.gov (Jan 2013)

The purpose of this study is to evaluate the effect of roflumilast alone and in combination with montelukast on forced expiratory volume in 1 second (FEV1) in patients with inadequately controlled asthma.

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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Inadequately Controlled Asthma and High Bronchodilator Reversibility

Clinical Trials Register.eu (Dec 2012)

To evaluate the efficacy of brodalumab compared with placebo as measured by the change in asthma control (based on the Asthma Control Questionnaire [ACQ]) from baseline at week 24 in subjects with inadequately controlled asthma and high reversibility despite standard of care.

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A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Adaptive-Design, Dose-Ranging Study of MK-1029 in Adult Subjects with Persistent Asthma

Clinical Trials Register.eu (Dec 2012)

This adaptive design, dose-ranging study of MK-1029 will assess the dose-related efficacy and safety of MK-1029 compared with placebo using measures of lung function (forced expiratory volume in 1 second (FEV1). The primary objectives are (1) To demonstrate that MK-1029, compared with placebo, results in dose-related improvements in FEV1 over the last 6 weeks of the 12-week active-treatment period; (2) To determine the dose-related safety and tolerability of MK-1029 as monotherapy and as concomitant dosing with monteulkast over 12 weeks.

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A randomized, double-blind, placebo- and comparator-controlled study evaluating the effect of multiple doses of QGE031 compared to omalizumab in asthma induced by allergen bronchial provocation

Clinical Trials Register.eu (Oct 2012)

To compare the effects of treatment every two weeks with 240 mg QGE031 versus omalizumab in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at 12 weeks compared to baseline

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A Randomized, Placebo-Controlled, Phase IIb Dose-Finding Study of CYT003-QbG10, a TLR9-Agonist, in Patients with Moderate to Severe Allergic Asthma not Sufficiently Controlled on Current Standard Therapy (GINA Steps 3+4)

Clinical Trials Register.eu (Sep 2012)

The primary objective of this study is to assess the therapeutic potential and safety/tolerability of QbG10 at 3 dose levels versus placebo in patients with persistent moderate to severe allergic asthma not sufficiently controlled on current standard inhaled corticosteroids (ICS) with or without long-acting β2 agonist (±LABA) therapy (Global Initiative for Asthma [GINA] steps 3 and 4)

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A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled, Persistent Asthma

Clinical Trials Register.eu (Aug 2012)

To determine the efficacy of 3 different doses of AZD5069 compared with placebo on the rate of severe asthma exacerbations over 6 months in adults with uncontrolled persistent asthma, despite treatment with medium to high dose inhaled corticosteroids (≥fluticasone 500 µg or the equivalent daily) and long acting β2 agonists.

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A multicenter, randomized, double-blind, placebo controlled, 12-week treatment, parallel-group study to assess the efficacy, safety and pharmacokinetics of indacaterol acetate (75 and 150 μg o.d.) in patients with persistent asthma

Clinical Trials Register.eu (Aug 2012)

To demonstrate superiority of indacaterol acetate 75 or 150 μg to placebo with respect to 24 h postdose trough FEV1 after 12 weeks of treatment in patient with persistent asthma.

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Exercise induced bronchoconstriction in children – a single dose of montelukast as alternative to regular daily doses.

Clinical Trials Register.eu (Jul 2012)

To compare the effect of a single dose of montelukast and regular daily use of montelukast in children with exercise induced bronchoconstriction.

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MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects with Severe Refractory Asthma

Clinical Trials Register.eu (Jul 2012)

To compare the effects of mepolizumab adjunctive therapy with placebo on reducing the use of maintenance oral corticosteroids (OCS) in systemic corticosteroid dependent subjects with severe refractory asthma with elevated eosinophils.

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A Phase 2, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of KB003 in Subjects with Asthma Inadequately Controlled by Corticosteroids

Clinical Trials Register.eu (Jun 2012)

The primary objective of study KB003-04 is to evaluate the effect of KB003 on lung function in subjects with asthma inadequately controlled by corticosteroids, as measured by absolute change in percent predicted FEV1.

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A randomised double-blind, parallel group, dose-ranging study to evaluate the efficacy and safety of three different total daily doses of fluticasone propionate inhaled from a new dry powder inhaler in subjects with severe persistent asthma requiring oral corticosteroid therapy

Clinical Trials Register.eu (Jun 2012)

To evaluate the clinical efficacy and dose-response relationship, using oral corticosteroid (OCS) modulation, of 3 different total daily doses of Fluticasone Propionate Inhalation Powder taken using a twice daily regimen from nDPI for 16 weeks in subjects with severe persistent asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative for Asthma (GINA) guidelines (GINA 2011).

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A phase IIb, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and dosing regimens of MEMP1972A in adults with allergic asthma who are inadequately controlled on inhaled corticosteroids and a second controller (COSTA)

Clinical Trials Register.eu (Jun 2012)

The primary objectives of this study are to evaluate the efficacy and safety of MEMP1972A in adult patients with allergic asthma inadequately controlled despite high dose inhaled corticosteroids ( ICS) (≥ 400 μg/day total daily dose of fluticasone propionate [FP] or equivalent) and a second controller after 36 weeks of treatment.

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A randomized, double-blind, double-dummy, 4-week treatment, parallel-group study to evaluate the efficacy and safety of two doses of mometasone furoate delivered via Concept1 or Twisthaler® in adult and adolescent patients with persistent asthma

Clinical Trials Register.eu (Jun 2012)

To demonstrate the non-inferiority of MF 80 µg and 320 µg delivered via Concept1 to MF 200 µg and 800 µg delivered via Twisthaler® in terms of 24 h post-dose trough FEV1 after 4 weeks treatment.

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A 12-month, open label, randomised, effectiveness study to evaluate fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) Inhalation Powder delivered once daily via a Novel Dry Powder Inhaler compared with usual maintenance therapy in subjects with Asthma

Clinical Trials Register.eu (Apr 2012)

The objective of the study is to compare the effectiveness of fluticasone furoate(FF)/vilanterol (VI) Inhalation Powder (FF 100mcg/VI 25mcg or FF 200mcg/VI 25mcg) with usual asthma maintenance therapy over twelve months in a large UK primary care population of subjects with Asthma. FF/VI will be administered once-daily (QD) via the Novel Dry Powder Inhaler (NDPI).

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A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No. P06241 also known as P202)

Clinical Trials Register.eu (Mar 2012)

To compare serious asthma outcomes (a composite endpoint defined as asthmarelated: hospitalizations, intubations, and deaths) in subjects treated with MF/F MDI BID versus subjects treated with MF MDI BID.

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A 12-Week, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Mometasone Furoate Metered Dose Inhaler in the Treatment of Children Ages 5 to 11 Years With Persistent Asthma

Clinical Trials Register.eu (Feb 2012)

To demonstrate the dose-related efficacy by evaluating morning lung function at the end of the dosing interval (AM pre-dose percent predicted forced expiratory volume in one second [FEV1]) after 12 weeks of treatment, of three doses (50 mcg, 100 mcg, and 200 mcg) of mometasone furoate (MF) metered dose inhaler (MDI) twice a day (BID) compared with placebo in children 5 to 11 years of age, inclusive, with persistent asthma.

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Tolerance and effect of an add-on therapy with an ivy leaves dry extract syrup on lung function in children with asthma.

Clinical Trials Register.eu (Feb 2012)

To evaluate the effect of an additional therapy with Prospan on the lung function parameters MEF75-25 and FEV1 (relative change)

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Evaluation of any steroid sparing effect of beta blocker therapy on airway hyper-responsiveness in stable, mild to moderate, asthmatics.

Clinical Trials Register.eu (Dec 2011)

Do any effects on airway 'twitchiness' in asthma with chronic dosing of beta blockers and low dose steroid inhaler differ with being on a high dose steroid inhaler?

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SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects with Asthma.

Clinical Trials Register.eu (Dec 2011)

The primary objective of the study is to evaluate whether the addition of LABA to ICS therapy (FSC) is non-inferior to ICS therapy alone (FP) in terms of the risk of serious asthma related events (asthma-related hospitalization, endotracheal intubation, and death).

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HZA106853: A dose-ranging study of vilanterol (VI) inhalation powder in children aged 5-11 years with asthma on a background of inhaled corticosteroid therapy.

Clinical Trials Register.eu (Nov 2011)

The primary objective is to evaluate the dose response, efficacy and safety of three doses of VI inhalation powder administered once daily in the evening in children aged 5-11 years with persistent uncontrolled asthma over a 4 week treatment period.

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A 6-month safety and benefit study of inhaled fluticasone propionate/ salmeterol combination versus inhaled fluticasone propionate in the treatment of 6,200 pediatric subjects 4-11 years old with persistent asthma

Clinical Trials Register.eu (Nov 2011)

The primary objective is to evaluate whether the addition of a LABA to an ICS (FSC) therapy is non-inferior in terms of risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) compared with ICS alone (FP) in pediatric subjects (age 4-11 years) with persistent asthma.

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A double-blind, placebo-controlled, study examining the effect of orally administered QAW039 on sputum eosinophil levels and other efficacy outcomes in patients with sputum eosinophilia and persistent asthma

Clinical Trials Register.eu (Nov 2011)

To demonstrate a statistically significant reduction in sputum eosinophil levels in inadequately controlled, moderate-to-severe asthmatics (GINA 2- 5), with sputum eosinophilia after treatment with QAW039 for 12 weeks compared to placebo.

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E-support for Healthcare Processes - ASTHMA (E-ASTHMA)

Clinicaltrials.gov (Oct 2011)

The purpose of the study is to establish and clinically evaluate a new approach to treating asthma by using information and communication technologies (ICT). A mobile environment, and organizational interventions to improve the process of an integrated treatment of people with asthma will be identified, developed, introduced and clinically evaluated.

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Assessing Decision Maker Tools for Asthma: the Asthma APGAR

Clinicaltrials.gov (Oct 2011)

This study provides one half of the enrolled primary care offices with the Asthma APGAR which is a system of patient completed questions and a care flow sheet. The other half of the enrolled practices will continue to provide "usual" care without the support of the Asthma APGAR system. The research questions is whether or not asthma control and asthma related quality of life will be improved in people with asthma who are cared for in the intervention practices that use the Asthma APGAR system.

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Reduce IDentified UNcontrolled Asthma (RIDUNA)

Clinicaltrials.gov (Oct 2011)

The purpose of Reduce IDentified UNcontrolled Asthma (RIDUNA) is to determine the benefit of real-time identification of uncontrolled asthma by electronic administrative records linked to real-time notification of uncontrolled status to patients and asthma specialists with recommended guideline directed intervention by physicians. The investigators hypothesize that real-time outreach following National guideline asthma care recommendations, after real-time identification of an uncontrolled asthma event in persistent asthmatics on inhaled corticosteroids will lead to better improvements in asthma control (impairment and risk) compared to standard asthma care outreach.

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Effects of Educational Intervention on Long-Term Outcomes of Hospitalized Children With Asthma (IHOP)

Clinicaltrials.gov (Sep 2011)

The investigators hypothesize that reinforced asthma education improves long-term outcomes in children with asthma.

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Control of moderate or severe asthma with 160, 320 and 640μg ciclesonide/day. A one-year randomised, double-blind, multicenter trial.

Clinical Trials Register.eu (Jun 2011)

The aim of the trial is to investigate whether long-term treatment with 320 and 640μg ciclesonide/day for one year improves asthma control in subjects with lack of asthma control while on 160μg ciclesonide/day. Additionally, the trial will provide further data on the long-term safety and tolerability of ciclesonide.

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A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults with Uncontrolled, Severe Asthma

Clinical Trials Register.eu (May 2011)

To evaluate two SC treatment regimens of 300 mg tralokinumab compared with placebo by assessing the effect on asthma exacerbation rate over 52 weeks in adults with uncontrolled, severe asthma requiring high-dose ICS and LABA with or without additional asthma controller medications.

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Influence of an Asthma Education Programme on Asthma Control During Pregnancy

Clinicaltrials.gov (Apr 2011)

Asthma is the most frequent respiratory disease during pregnancy. In a third of cases, the level of asthma control can decrease during the pregnancy, especially between the 29th and the 36th week. The occurrence of such complications are linked with a high asthma severity level just before the conception and an history of respiratory complications in a previous pregnancy. Many reviews and recommendations claim that pregnant women with asthma should be included in an educational progamme. However, this is poorly studied. The purpose of this study is to observe if an educational programme given before the 20th weeks of gestation has an effect on asthma control until the end of gestation.

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Predicting Response to Azithromycin Therapy in Asthma

Clinical Trials Register.eu (Mar 2011)

The purpose of this study is to better understand the mechanistic effects of Azithromycin (AZM) in asthma, and to establish if AZM therapy is effective in a subgroup of patients with chronic asthma who have phenotypically distinct disease

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Smoking young asthmatics: Change of inflammation and quitting cessation rate – effect of Champix

Clinical Trials Register.eu (Jan 2011)

Research of changes in the asthmatic bronchial inflammation before and after tobacco cessation. Success rate of Champix in young asthmatics.

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Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics (GLITZ Asthma)

Clinicaltrials.gov (Jan 2011)

Asthmatics who are significantly overweight tend to have more severe symptoms, more flare ups, and are more likely to have poorly-controlled asthma when compared to other asthmatics. Researchers believe this occurs because excess adipose tissue (fat) in the body can cause higher-than-normal levels of leptin and lower-than-normal levels of adiponectin in the blood. The researchers of this study are testing a medication called pioglitazone in overweight asthmatics because they believe it can help regulate leptin and adiponectin and that this may improve symptoms of asthma.

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Randomised, multi-centre, double-blind, placebo-controlled trial of vitamin d supplementation in adult and adolescent patients with asthma

Clinical Trials Register.eu (Oct 2010)

Does vitamin D supplementation influence time to first severe exacerbation and time to first upper respiratory tract infection in patients with asthma?

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Promoting Asthma Wellness in Rural Communities

Clinicaltrials.gov (May 2010)

This is a research study that compares the effectiveness of a web-based program (known as Puff City) and another web-based program (of internet sites such as the American Lung Association, American Academy of Asthma, Allergy, and Immunology, etc) that targets five key asthma management issues among rural youth: 1. Improving adherence to asthma controller medication use; 2. Improving compliance of carrying a rescue inhaler at all times for use at the first sign of asthma symptoms; 3. Improving inhaler technique; 4. Smoking reduction or cessation in those who are smokers; and 5. Avoidance of second-hand smoke exposure.

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Small Particle Inhaled Steroids in Refractory Steroid-responsive Asthma

Clinical Trials Register.eu (Mar 2010)

In patients with poorly controlled asthma with evidence of persistent eosinophilic inflammation can the addition of extra inhaled corticosteroid that targets the distal airways improve asthma control and reduce the eosinophilic airway inflammation? The primary endpoint will be the difference in sputum eosinophil count between active and placebo groups at 8 weeks.

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Evaluation of Beta Blockers for the Treatment of Asthma. A randomised controlled trial of propranolol

Clinical Trials Register.eu (Mar 2010)

To establish whether chronic dosing with beta-blockers reduces airway inflammation in mild-to-moderate asthmatics on inhaled corticosteriods.

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The predictive value of the acute effect of beclomethasone on a mannitol challenge test for the outcome of lomgterm treatment with beclomethasone

Clinical Trials Register.eu (Mar 2010)

What is the correlation between change in Mannitol PD15 (provoking dose of mannitol to cause a ≥ 15% fall in FEV1 ) 6h after a single dose of beclomethasone and after 4 weeks of treatment with beclomethasone?

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The predictive value of the acute effect of montelukast on an exercise challenge test for the outcome of longterm treatment with montelukast

Clinical Trials Register.eu (Dec 2009)

What is the correlation between change in % fall in FEV1 (∆FEV1) after an exercise challenge 2h after a single dose of montelukast and after 8 weeks of treatment with montelukast?

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Impact of Aerobic Exercise on Asthma Morbidity (Ex-Asthma)

Clinicaltrials.gov (Aug 2009)

The current proposed study will assess the effects of aerobic exercise in sedentary patients with poorly controlled asthma. In addition to usual medical care, 52 patients will participate in a supervised aerobic exercise program. The program will consist of 3 X 1hr sessions of supervised exercise per week for 12 weeks. Another 52 patients will only maintain usual medical care. The asthma control, quality of life, and inflammatory profile will be evaluated at baseline and following the 12 weeks of treatment. The investigators believe that: (1) The exercise intervention will significant improve asthma control and asthma quality of life; (2) The exercise intervention will result in significant improvements in inflammatory profiles; and (3) These changes in the inflammatory profile will be directly related to the improvements in asthma control and quality of life.

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Effect of macrolides on asthma control, airway inflammation and bacterial colonisation in smokers with asthma

Clinical Trials Register.eu (Apr 2009)

This randomised controlled trial will test the hypothesis that macrolides improve asthma control and reduce sputum neutrophil counts of smokers with chronic asthma.

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Pediatric Asthma Alert Intervention for Minority Children With Asthma (PAAL)

Clinicaltrials.gov (Mar 2009)

Young inner-city children with asthma have the highest emergency department (ED) visit rates. Relying on the emergency department for asthma care can be a dangerous sign of poorly controlled asthma. This research will focus on whether having a specialized asthma nurse join the family at a child's doctor visit after an ED visit for asthma to make sure the child and parent keep the follow-up appointment and have the nurse remind the child's doctor to prescribe preventive asthma medicines and an asthma action plan for home (PAAL intervention) will result in young children with asthma having fewer days with wheezing and cough. The investigators hypothesize that: Significantly more children receiving the PAAL intervention will attend greater than 2 non-urgent visits and greater than 6 refills for the child's anti-inflammatory medications over 12 months when compared to children in the control or standard asthma education group. Also children in the PAAL intervention group will experience less morbidity and caregivers will experience increased quality of life compared to children in the control of standard asthma education group.

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Parents, Pediatricians, and Asthma Telephone Coaches Partner to Improve Control of Asthma in Children (The PARTNER Study)

Clinicaltrials.gov (Mar 2009)

Parents of children with asthma must work with their child's pediatrician to ensure that their child's asthma is managed well. Asthma coaches are one way to facilitate and support the relationship between parents and pediatricians. This study will evaluate whether access to a 12-month telephone asthma coaching program for parents is an effective way to improve asthma outcomes in children.

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Effect of montelukast on levels of metalloproteinase-9 (MMP-9), MMP-12, tissue inhibitor metalloproteinase-1 (TIMP-1), procollagen peptide type 1 C-terminal (PICP) and TGF-beta1 on induced sputum of children suffering from intermittent asthma.

Clinical Trials Register.eu (Dec 2008)

To evaluate if 4-weeks treatment with montelukast in children affected by intermittent asthma can significantly reduce levels of TIMP-1 on induced sputum.

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PPAR-gamma: A noval therapeutic target for asthma

Clinical Trials Register.eu (Jul 2008)

To test the hypothesis that stimulation of the PPAR-gamma receptor has a therapeutic role in the treatment of asthma

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Macrolides in Refractory Asthma

Clinical Trials Register.eu (May 2008)

To determine whether macrolides improve bronchial hyperresponsiveness in patients with refractory asthma

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A Multicenter, Randomized, Double-Blind, Parallel-Group 6-Month Study to Evaluate the Efficacy and Safety of Oral Montelukast Sodium, Fluticasone Propionate and Placebo in Patients with Chronic Asthma Who Smoke Cigarettes

Clinical Trials Register.eu (Feb 2006)

To compare the treatment effect of montelukast 10 mg vs. placebo in asthmatic patients who smoke cigarettes, over a 6 month treatment period on the percentage of asthma-control days.

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Efficacy and Safety Study of QAW039 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis.

Clinicaltrials.gov (Feb 2013)

The purpose of this study is to determine whether QAW039 is safe and has beneficial effects in people who have moderate to severe atopic dermatitis (AD).

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Efficacy of KAM2904 Face Cream and KAM3008 Body Lotion Treatment in Children With Atopic Dermatitis (AD)

Clinicaltrials.gov (Jan 2013)

The main purpose of this study is to demonstrate the safety and efficacy of KAM2904 Face Cream and KAM3008 Body Lotion in reducing the symptoms of mild to moderate AD. Efficacy will be evaluated by comparing SCORAD and Eczema Area Severity Index (EASI) in a group of subjects treated with KAM2904 Face Cream and KAM3008 Body Lotion (the treatment group), versus a group of subjects treated with a petrolatum-based moisturizer (the control group). Safety will be determined by the number and severity of Adverse Events Device-Related.

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Emollients in the Management of Atopic Dermatitis

Clinicaltrials.gov (Jan 2013)

The purpose of this study is to confirm that emollients play a major role in the maintenance therapy after clearing of inflammatory lesions and can reduce occurrence of flares in children with atopic dermatitis.

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Efficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in Children

Clinicaltrials.gov (Jan 2013)

The main objective is to investigate long-term management (16 weeks) of AD with fluticasone propionate (FP) 0,05% cream twice weekly in addition to an emollient (vehicle) after stabilization of an acute flare of AD with FP cream.

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Emollients in the management of atopic dermatitis in children: prevention of flares.

Clinical Trials Register.eu (Nov 2012)

To assess the ability of DEXERYL to prevent flares after treatment of a previous flare by a topical corticosteroid.

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A Randomised, Double-blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Topically Applied DGLA Cream in Patients with Mild to Moderate Atopic Dermatitis

Clinical Trials Register.eu (Oct 2012)

To compare the effectiveness of three doses of topically applied DGLA cream, versus placebo, in the treatment of adult patients with mild to moderate dermatitis

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A randomized, double-blind, parallel-group, placebo-controlled study to assess the safety of REGN668 administered concomitantly with topical corticosteroids to patients with moderate-to-severe Atopic dermatitis

Clinical Trials Register.eu (Apr 2012)

The primary objective of the study is to assess the safety of repeated subcutaneous (SC) doses of REGN668 administered concomitantly with topical corticosteroids (TCS) in adult patients with moderate-to-severe atopic dermatitis (AD).

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A Randomized, Double-Blind, Placebo-controlled, Three-arm, Parallel Assignment, Multi-centre, Therapeutic Equivalence Study of Two Tacrolimus 0.1% Topical Ointment Formulations in Adult Patients with Moderate to Severe Atopic Dermatitis

Clinical Trials Register.eu (Apr 2012)

The primary objective is to establish the therapeutic equivalence between tacrolimus ointment 0.1%, manufactured by Intas Pharmaceuticals Ltd., India and Protopic® (tacrolimus), 0.1% topical ointment manufactured by Astellas Pharma B.V., The Netherlands and marketed by Astellas Pharma Europe Ltd. and to show superiority over vehicle in the treatment of moderate to severe Atopic Dermatitis in adult population.

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A randomized, double-blind, placebo-controlled, repeat-dose study of the efficacy, safety, tolerability, and pharmacodynamics of subcutaneously-administered REGN668 in adult patients with extrinsic moderate-to-severe atopic dermatitis

Clinical Trials Register.eu (Dec 2011)

The primary objective is to assess the clinical efficacy of repeated subcutaneous (SC) doses of REGN668 in adult patients with moderate-to-severe atopic dermatitis (AD).

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A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome

Clinicaltrials.gov (Aug 2011)

The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will be assessed in two different patients groups to evaluate safety and efficacy in atopic dermatitis (Part 2) and in Netherton syndrome (Part 3).

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Interferon Responses in Eczema Herpeticum (ADEH) (IFN)

Clinicaltrials.gov (Jul 2011)

Atopic dermatitis (AD) is a chronic skin disorder characterized by recurrent viral skin infections. A small subset of patients with AD suffer from disseminated viral infections, e.g., eczema herpeticum (ADEH+), after herpes simplex infection (HSV) or eczema vaccinatum (EV) after smallpox vaccination. Interferon (IFN)-γ plays a critical role in the innate and acquired immune responses by activating macrophages, enhancing natural killer cell activation, and promoting T cell differentiation, as well as regulating B cell isotype switching to immunoglobulin (Ig) G2a. Recent studies have demonstrated that IFN-γ generation was significantly decreased after stimulation with HSV ex vivo. The purpose of this study is to determine if deficient IFN-γ induction leads to susceptibility to HSV infection in ADEH+ patients.

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Comparison of Moisturisers for the Prevention of Atopic Dermatitis Relapse– a Randomised, Double Blind Controlled Study (COMPADRE)

Clinical Trials Register.eu (Jun 2011)

The primary objective is to show that a barrier strengthening moisturiser is superior to a base cream in preventing eczema relapse in patients with AD.

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The role of anti-IgE (omalizumab) in the management of severe recalcitrant paediatric atopic eczema

Clinical Trials Register.eu (Apr 2011)

To determine if anti-IgE can improve very severe eczema in children, who have not responded to the usual 1st and 2nd line treatments for eczema (assessed by the eczema severity score, SCORAD), as compared to a placebo.

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Proof of concept study of combined allergen immunotherapy and antibiotics for the treatment of chronic atopic eczema

Clinical Trials Register.eu (Oct 2010)

To test whether combined antibiotics and allergen-immunotherapy (desensitisation to the allergen house dust mite) lead to clinical improvement in adults with severe atopic eczema.

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Evaluate Reversal of Pathological Epidermal Phenotype in Severe Atopic Dermatitis (AD) With Suppression of Immune Activation During Cyclosporine A Therapy

Clinicaltrials.gov (Jun 2010)

Atopic Dermatitis (AD) or eczema is a chronic relapsing inflammatory disease that affects 1-3% of the adults and up to 25% of the children in the United States. Patients with severe AD will be studied during a 24-week study with systemic cyclosporine (Neoral, capsule form) to evaluate the immune suppression and pathological correlation of cyclosporine A in these patients in order to determine the extent to which immune activation drives the pathological epidermal phenotype.

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A Pilot Study Using Anakinra/Kineret for the Treatment of Patients With Severe Atopic Dermatitis

Clinicaltrials.gov (May 2010)

To assess the safety and effectiveness of using anakinra to treat severe atopic dermatitis in children.

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A multicenter, randomized, intra-individual, double blind, vehicle-controlled study to evaluate the efficacy and safety of CD2027 ointment 9µg/g applied twice daily over 4 weeks in the treatment of target lesions in adults subjects with atopic dermatitis

Clinical Trials Register.eu (May 2009)

To evaluate the efficacy and safety of CD2027 ointment 9µg/g applied twice daily over 4 weeks versus its vehicle on target lesions in adult subjects with Atopic dermatitis.

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A multi-centre, double-blind, placebo-controlled, randomised group-comparative study to evaluate the efficacy and safety of Altoderm, a topically applied sodium cromoglicate lotion, in the treatment of atopic dermatitis in children.

Clinical Trials Register.eu (Jan 2009)

To evaluate the efficacy and safety of topically applied Altoderm in the treatment of atopic dermatitis in children.

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Impact of the V0034CR 01B emollient on atopic dermatitis symptoms in children. A randomised, placebo-controlled, parallel-groups, double-blind study

Clinical Trials Register.eu (Aug 2008)

To evaluate, in children presenting with atopic dermatitis, the impact of a daily treatment by the emollient V0034CR 01B on the disease symptoms: evolution of the POEM (Patient-Oriented Eczema Measure) score.

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Studies of Skin Microbes in Healthy People and in People With Skin Conditions

Clinicaltrials.gov (Jan 2008)

This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema.

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Phase IIa, randomized, double-blind, placebo-controlled, intra-individual left-right limb comparison trial in 25 patients with moderate atopic dermatitis to investigate the efficacy, local irritation, safety, tolerability and pharmacokinetics of twice daily topical applications with 10% ImCOOH cream for 14 days with an additional morning application on Day 15.

Clinical Trials Register.eu (Nov 2007)

Main objectives of the trial are to determine the efficacy of topical applications of ImCOOH cream administered for 14 days with an additional morning application on Day 15 in patients with atopic dermatitis; and to determine the safety and tolerability of topical applications of ImCOOH cream administered for 14 days with an additional morning application on Day 15 in patients with atopic dermatitis.

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A multicenter, randomized, double-blind clinical study to examine the efficacy and safety of Zarzenda® in comparison to Elidel® in the management of mild to moderate atopic dermatitis in children and adolescents.

Clinical Trials Register.eu (Sep 2007)

The primary objective of the study is to show therapeutic efficacy of Zarzenda® cream versus Elidel® 1% cream in children and adolescents with mild to moderate atopic dermatitis.

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Double-Blind, Randomised, Active And Placebo Controlled Study To Assess The Clinical Efficacy, Skin Tolerability And Pharmacological Activity Of A New Topical Compound (Ur-1505 0.5%, 1% And 2%) In Patients With Mild To Moderate Atopic Dermatitis

Clinical Trials Register.eu (Jun 2007)

To explore the clinical efficacy of UR-1505 (0,5%, 1% and 2%) applied once daily during 4 weeks, compared with a vehicle without active ingredients and with an active treatment, in adult patients with mild to moderate atopic dermatitis.

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Risk of Asthma in Infants With Atopic Dermatitis

Clinicaltrials.gov (Apr 2007)

Infants will be enrolled in this study if they have never been diagnosed with asthma or wheezing and have been diagnosed with atopic dermatitis or eczema. Infants with some types of skin rashes are at high risk for developing asthma by 6 years of age. The purpose of this study is to determine whether we can identify infants who will develop asthma.

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LEO19123 Cream in the Treatment of Atopic Dermatitis A Phase II, proof of concept study, testing once daily use of two dose-combinations of LEO19123 cream (calcipotriol and LEO80122) in the treatment of atopic dermatitis

Clinical Trials Register.eu (Jan 2007)

To compare the clinical efficacy of LEO19123 cream (calcipotriol 50 mcg/g and LEO80122 0.6 mg/g), LEO19123 cream (calcipotriol 15 mcg/g and LEO80122 0.2 mg/g), and LEO19123 cream vehicle alone, in patients with atopic dermatitis after once daily treatment for three weeks.

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A study to evaluate the role of tacrolimus ointment (Protopic®) 0.1% in the treatment of chronic otitis externa.

Clinical Trials Register.eu (Dec 2006)

To establish the effectiveness of Tacrolimus ointment as a treatment for chronic eczematous otitis externa. This will be evaluated by treatment group comparisons of the patient diary cards, the ENT Specialist’s evaluation and overall assessment.

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A two months study of the utility of Elidel cream 1% (pimecrolimus) in the long term management of atopic hand eczema.

Clinical Trials Register.eu (Aug 2006)

To investigate if an Pimecrolimus (pimecrolimus) based treatment regime prolongs the time to relapse after control of a flare compared with a treatment with Pimecrolimus vehicle plus emollients in patients with chronically relapsing atopic hand eczema.

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A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders

Clinicaltrials.gov (Feb 2013)

This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of concept study will investigate the efficacy and safety of RG7314 in adult patients with autism spectrum disorders. In stage I of the study, patients will be randomized to receive daily oral doses of 1.5 mg RG7314or placebo for 12 weeks. After an independent safety review, the study may proceed to stage II. In stage II of the study, additional patients will be randomized to receive daily oral doses of 1.5mg, 4 mg of RG7314 or placebo for 12 weeks. After an interim efficacy and safety analysis, additional patients may be randomized to receive daily oral doses of 1.5 mg, 4 mg of RG7314 or placebo for 12 weeks. The anticipated time on study treatment is 12 weeks.

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Melatonin Dose-effect Relation in Childhood Autism (MELADOSE)

Clinicaltrials.gov (Jan 2013)

Melatonin is a neurohormone produced from serotonin which promotes sleep. The alterations in central and peripheral serotonin neurobiology and in circadian sleep-wake rhythms observed in autistic disorder suggest abnormalities in melatonin secretion. Several studies have reported a decrease in melatonin secretion in individuals with autism. Furthermore, nocturnal excretion of 6-Sulphatoxymelatonin (the predominant melatonin metabolite) was significantly negatively correlated with severity of autistic impairments in verbal communication and play. Melatonin could therefore have a therapeutic effect on sleep problems and may play a role in the pathophysiology of autistic disorder. These data highlight the possible therapeutic interest of an oral administration of melatonin in patients with autistic disorder. Thus, the objective of this clinical trial is to study the relation between the melatonin dose administered and its effect on severity of autistic impairments especially in verbal communication and play.

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Neurophysiological Molecular and Developmental Analysis of the Glutamate Synapse in Autism (NMDA-Autism)

Clinicaltrials.gov (Jan 2013)

Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism

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A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients with Autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated with Memantine

Clinical Trials Register.eu (Jun 2012)

To evaluate the safety, tolerability, and efficacy of memantine therapy compared with placebo in pediatric patients with autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) previously on stable memantine therapy utilizing a randomized withdrawal paradigm.

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An Open-Label Study Of The Safety And Tolerability Of Memantine In Pediatric Patients With Autism, Asperger’s Disorder, Or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Clinical Trials Register.eu (Jun 2012)

The objective of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in the follow-up randomized withdrawal study

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Adipose Derived Stem Cell Therapy for Autism

Clinicaltrials.gov (Dec 2011)

The intent of this clinical study is to answer the questions: - Is the proposed treatment safe - Is treatment effective in improving the disease pathology of patients with Autism.

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Efficacy of RAD001/everolimus in Autism and NeuroPsychological deficits in children with TSC (RAPIT-trial)

Clinical Trials Register.eu (Dec 2011)

The primary objective is to determine the effect of Everolimus on the cognition of children with TSC, measured by IQ.

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Efficacy of agomelatine on sleep disturbance in Autism Spectrum Disorder (ASD)

Clinical Trials Register.eu (Nov 2011)

To study the efficacy of agomelatine in improving the quantity and quality of sleep in patients with ASD as recorded by an integrated variable TAP.

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Social Cognitive Development in Young Children With Autism

Clinicaltrials.gov (Jun 2011)

Through the development of a novel treatment targeting core Autism Spectrum Disorder (ASD) social deficits and studying the efficacy of this intervention, the investigators hope to provide a means for children with ASD to more effectively and efficiently process social information and enable them to more successfully engage in social interactions. Children between the ages of 24 and 36 months and their families may join.

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Behavioral effects and neural correlates of oxytocin on social attention

Clinical Trials Register.eu (Dec 2010)

The overall aim of the proposed project is to investigate attentional processes in a social context and to modulate these processes by OXT. Based on the literature to date, it seems plausible that OXT modulates social cognitive processes such as the attention to emotional facial expressions differentially in ASD and neurotypical controls. Thus, the present study aims to investigate the modulatory role of OXT on attentional capture of social stimuli with varying emotional valence on the behavioral level in both typically developing adults as well as individuals with ASD. Participants will receive either OXT or a placebo in a randomized, double-blind group design.

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Genetic Contributions to Autism Spectrum Disorders

Clinicaltrials.gov (Jul 2010)

This study is working towards gaining a better understanding of the genetic and environmental factors involved in autism spectrum disorders (ASD), which includes autism, pervasive developmental disorder (PDD), and Asperger's syndrome. The investigators hope that information gained from this study will lead to new ways of diagnosing and treating ASDs.

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Short- and long-term effects of oxytocin on empathy and social behaviour in autistic and antisocial male adults.

Clinical Trials Register.eu (Apr 2010)

To investigate the effectiveness of 4-weeks treatment with intranasally adminsitered oxytocin twice a day versus placebo in improving social behaviour in patients with antisocial personality disorder and in those with autism spectrum disorder

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Craniosacral Therapy to Treat Chronic Low Back Pain

Clinicaltrials.gov (Mar 2013)

The purpose of this study is to determine whether a craniosacral therapy program are effective on disability, quality of life, autonomic nervous system and oxidative stress indicators in patients with chronic low back pain.

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Efficacy Study of Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain (POETS)

Clinicaltrials.gov (Feb 2013)

The objective of this study is to investigate the short- and long-term efficacy of a Cognitive Behavioural Treatment program for chronic low back pain supported by information and communication technologies

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Study of the Efficacy of Manual Therapy for a Subgroup of Acute Non-specific Low Back Pain

Clinicaltrials.gov (Feb 2013)

The purpose of this study is to validate or not the interest of the classification using the pragmatic application of clinical predictive rule for low back pain to identify patients with good prognosis following a brief spinal manipulation intervention.

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Manipulative Therapy Techniques to Treat Chronic Low Back Pain

Clinicaltrials.gov (Feb 2013)

The purpose of this study is to analyze the effectiveness of a three manipulative therapy techniques in People with Chronic Low Back Pain.

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Lumbar Proprioception in Lower Back Pain Patients Versus Healthy Subjects : a Comparative Study on the Effects of Low- and High-frequency Muscle Vibrations (Vibrioception)

Clinicaltrials.gov (Feb 2013)

The primary objective of this study is to compare the lumbar proprioception of patients with chronic back pain to that of healthy volunteers during low- and high-frequency muscle vibration.

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"Cognitive Functional Therapy" vs. Manual Therapy for Non-specific Low Back Pain

Clinicaltrials.gov (Jan 2013)

This is a pilot study. Chronic LBP is a major health care problem in Denmark. Few patients receive a specific diagnosis, leaving the majority of patients diagnosed with non specific low back pain(NSLBP). Classification systems can help to guide the treatment of NSLBP. This pilot study will compare manual therapy (manipulation and soft tissue treatment)and exercises to a classification based biopsychosocial intervention (a cognitive/functional approach) as described by Peter O`Sullivan, on a subgroup called "flexion pattern" This pilot study has three specific aims: (i) To determine the mean and standard deviation on the numerical rating scale of participants in this setting who have a motor control flexion pattern, so that sample size calculations for a fully powered randomized controlled trial could be performed. (ii) To test the logistical and practical procedures that will be required to perform a fully powered randomized controlled trial using these two treatments. (iii) To gain a preliminary estimate of any difference in the effect of these two treatments, so as to determine if the results of a fully powered randomized controlled trial might be clinically important and therefore worthwhile undertaking

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Pilot Evaluation to Assess the Clinical and Economic Impact of Pfizer's Pain Management Program (painPREMIER) in the Treatment of Low Back Pain, in an Occupational Health Care Setting in Finland

Clinicaltrials.gov (Jan 2013)

The aim of this investigation is to determine whether the use of painPREMIER will significantly improve function in patients with low back pain in an occupational health clinical setting. painPREMIER is a tool that assists clinicians in the accurate diagnosis of back pain and associated problems in order to treat them most effectively.

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Decoding Chronic Pain With fMRI

Clinicaltrials.gov (Jan 2013)

Recent evidence suggests that chronic pain is associated with abnormal connectivity between brain regions associated with the processing of pain. We aim to test the diagnostic power of resting state functional magnetic resonance imaging (MRI) to diagnose patients with chronic back pain. Using new methods of image acquisition and analysis we aim to develop a computational method to correctly classify patients and matched control subjects.

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The effect of dexamethasone in combination with paracetamol and ibuprofen as adjuvant, postoperative pain after herniated disk surgery

Clinical Trials Register.eu (Nov 2012)

To investigate the effect of dexamethasone in combination with paracetamol and ibuprofen as adjuvant, postoperative pain after herniated disk surgery

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Nonivamide/Nicoboxil Ointment in Acute Low Back Pain

Clinicaltrials.gov (Oct 2012)

The aim of this study is to assess the efficacy and tolerability of Nicoboxil/Nonivamide ointment in comparison to Nicoboxil, Nonivamide, and placebo ointments for the treatment of acute low back pain to obtain a market authorization in Germany for this indication.

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Efficacy, safety, and tolerability of GRT6005 in subjects with moderate to severe chronic low back pain

Clinical Trials Register.eu (Oct 2012)

The objective of this trial is to assess the analgesic efficacy, safety, and tolerability of once daily orally administered GRT6005 in a total of 3 fixed doses (i.e., 200 μg, 400 μg, and 600 μg GRT6005) compared to placebo in subjects with moderate to severe chronic LBP.

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Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies. (MODISC)

Clinicaltrials.gov (Sep 2012)

The treatment of chronic low back pain is a major objective of public healthcare, because it causes an important number of sick leaves. A correlation between clinical observations and an inflammatory discopathy has been underlined, but there is currently any reference treatment. In this study, the main objective is to assess the efficacy of an intradiscal injection of corticoids versus local anaesthetic on the treatment of pain of patients with low back pain associated to a Modic I discopathy.

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Efficacy, safety, and tolerability of GRT6005 in subjects with moderate to severe chronic low back pain

Clinical Trials Register.eu (Aug 2012)

The objective of this trial is to assess the analgesic efficacy, safety, and tolerability of once daily orally administered GRT6005 in a total of 3 fixed doses (i.e., 200 μg, 400 μg, and 600 μg GRT6005) compared to placebo in subjects with moderate to severe chronic LBP.

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The effect of a single skin treatment with Capsaicine 8% in low back pain

Clinical Trials Register.eu (Apr 2012)

We want to demonstrate the efficacy of a single skin treatment with capsaicin 8% patch (Qutenza®) in patients suffering from low back pain with a neuropathic pain component according to the classification of symptoms with the Pain Detect questionnaire (scores > 18, neuropathic pain) compared to patients without a clear neuropathic pain component (scores ≤ 18 -13).

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A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects with Controlled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation who Require Around-the-clock Opioid Therapy

Clinical Trials Register.eu (Apr 2012)

To assess the analgesic efficacy of OXN compared to placebo in opioid-experienced subjects with moderate to severe low back pain and opioid-induced constipation who require around-the-clock opioid therapy and To assess the efficacy of OXN for the management of opioid-induced constipation (OIC) compared with OXY in subjects with moderate to severe low back pain and opioid-induced constipation who require around-the clock opioid therapy.

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A multi-centre, double-blind, randomised, parallel group study to assess the efficacy and safety of multiple doses of topically applied hyperemisation-inducing ointment (2 cm ointment line per application; up to 3 times daily for up to 4 days) containing 2.5% Nicoboxil/0.4% Nonivamide versus 2.5% Nicoboxil, 0.4% Nonivamide and placebo in patients 18 to 65 years of age with acute low back pain

Clinical Trials Register.eu (Mar 2012)

The objective of this trial is to demonstrate superior efficacy of a hyperemisation-inducing ointment containing 2.5% Nicoboxil/0.4% Nonivamide over 2.5% Nicoboxil and 0.4% Nonivamide and placebo for the treatment of acute low back pain in patients aged 18 to 65 years

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Effectiveness of leech therapy in treatment of chronic low back pain - a randomised controlled clinical study

Clinical Trials Register.eu (Dec 2011)

Changes in the VAS (100mm) pain score 7 days after leech treatment

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Acupuncture in Acute Nonspecific Low Back Pain (Acuback)

Clinicaltrials.gov (Sep 2011)

The investigators aim to explore whether acupuncture treatment has effect on time to recovery as an addition to the standard treatment in general practice according to national guidelines.

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Collaborative Care for Older Adults With Back Pain (COCOA)

Clinicaltrials.gov (Jun 2011)

The purpose of the Collaborative Care for Older Adults with Back Pain (COCOA) Clinical Trial is to evaluate the clinical effectiveness and feasibility of a collaborative care model (medical and chiropractic care) through a pragmatic, prospective pilot trial conducted with 120 older adults over the age of 65 with low back pain of at least 1 month duration.

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Observational Cohort Study of Chronic Low Back Pain

Clinicaltrials.gov (May 2011)

This research study is being done to understand the outcomes of back pain treatment and costs associated with it in an academic hospital outpatient setting. The investigators will conduct a prospective observational cohort study to assess the clinical outcomes and utilization of health care services of 150 Osher Clinical Center (OCC) patients with chronic low back pain (CLBP) compared with a comparison group of 150 non-OCC CLBP patients treated within Brigham and Women's Hospital. Outcomes will include assessment of functional status, symptom relief, satisfaction with care, health-related quality of life, and worker productivity, and will be measured in person at baseline, and by phone by an interviewer blinded to cohort group at 3, 6, and 12 months.

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Yoga vs. Physical Therapy for Chronic Low Back Pain in Minority Populations

Clinicaltrials.gov (Apr 2011)

The application's primary aim is to determine the comparative effectiveness of yoga, physical therapy, and education for three outcomes at 12 weeks: pain intensity, back-specific function, and use of pain medication. For each of these outcomes, patients randomized to the yoga group are hypothesized to demonstrate clinically and statistically greater improvements than patients in the physical therapy or education groups. After the 12 week intervention period, half of the yoga and physical therapy participants will be randomly selected to participate in a 40 week ongoing structured yoga or physical therapy maintenance program. Pain, function, and pain medication use will be compared between maintenance and non-maintenance groups. Cost and utilization data will also be collected so cost effectiveness analyses from the perspective of society, the third party payer, and the patient can be performed. Together, results from these studies will help determine whether it is justifiable for yoga, currently a "complementary" therapy, to become an acceptable "mainstream" treatment for chronic low back pain.

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Intradiscal Methylene Blue Injection Treatment for Chronic Discogenic Low back pain A prospective Clinical Series followed by a Randomised Placebo-Controlled Clinical Trial

Clinical Trials Register.eu (Jul 2010)

The Randomized Clinical Trial (RCT) aims to prove the hypothesis that Intradiscal Methylene blue Injection is capable of better pain reduction than the best available treatment in patients suffering from axial low back pain of discogenic origin

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Randomized Double-blind Study Comparing the Efficacy of Duloxetine with Placebo in Patients with Chronic Low Back Pain

Clinical Trials Register.eu (Apr 2010)

• Weekly mean of VAS-Score in the last week of each treatment period • Use of rescue medication

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A multicentre, double-blind, randomised, active- and placebo-controlled clinical trial on the pain relieving effects of the modfied-release formulation of flupirtine in patients suffering from moderate to severe chronic low back pain

Clinical Trials Register.eu (Jul 2009)

The primary objectives of this study are to demonstrate either non-inferior pain relieving effects of the modified-release formulation of flupirtine (400mg OD in the evening) in comparison to extended-release tramadol (200mg OD in the evening) as well as a superior analgesic efficacy of flupirtine MR (400mg OD in the evening) in comparison to placebo in patients suffering from moderate to severe chronic low back pain (CLBP) after a four week treatment course.

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Association Between Low Back Pain and Quality of Sleep

Clinicaltrials.gov (May 2009)

A prospective study to assess the association between the change in quality of sleep and the change in intensity of pain in Spanish patients seen for subacute or chronic low back pain. The objective is to determine the prevalence of sleep alterations, the association between quality of sleep and intensity of pain, degree of disability, intensity of catastrophizing and depression.

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Effect of Interventions in Return to Work for Patients With Neck and Low Back Pain

Clinicaltrials.gov (Feb 2009)

The main purposes of this study: to investigate if rehabilitation programs specifically focusing on the return to work process will reduce sickness absence and disability pension in patients with neck and low back pain. To assess the work-, individual- and health factors and their interrelationship predicting sickness absence and work disability. To compare results from the rehabilitation program with results from rehabilitation program in Toronto. To which extent are the patients met by actions from employers and employment services, and does is influence sickness absence and disability and do these actions represent favourable cost benefit for the work places and the society?

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An Educational and Exercise Program as Secondary Prevention of Recurrent Lower Back Pain in Healthcare Workers (PRESLO)

Clinicaltrials.gov (Oct 2008)

The purpose of this randomized controlled trial is to assess the effectiveness of physical exercise combined with an educational program and self-led exercise for Lyon University Medical Center workers with lower back pain. We hope this intervention will reduce the risk of recurrence and chronic lower back pain.

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Antibiotic treatment of patients with low back pain and Modic changes after a lumbar disc herniation. A randomized clinical controlled trial.

Clinical Trials Register.eu (May 2008)

The aim of this study is to evaluate the efficacy of antibiotic treatment to patients with Low Back Pain and Modic changes after a lumbar disc herniation, and to evaluate if there is a dose-response relationship in different doses of antibiotics.

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Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients with Chronic Low Back Pain

Clinical Trials Register.eu (Nov 2006)

The primary objective of this study is to assess the efficacy of duloxetine 60 mg once daily (QD) to 120 mg QD compared with placebo on the reduction of pain severity as measured by the weekly mean of the 24-hour average pain scores in patients with chronic low back pain (CLBP) during a 13-week, double-blind acute treatment period using an 11-point Likert scale and an electronic patient diary.

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Epidural steroid injection in chronic, lumbar back pain; a cross-over, single-blinded study of Methyl-prednisolone 80mg versus Methyl-prednisolone 40mg.

Clinical Trials Register.eu (May 2006)

Epidural steroid injection in chronic, lumbar back pain; a cross-over, single-blinded study of Methyl-prednisolone 80mg versus Methyl-prednisolone 40mg.

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A randomised, double-blind, double-dummy, parallel-group multicenter study to demonstrate improvement in symptoms of constipation in subjects with non-malignant pain taking oxycodone equivalent of 60 - 80 mg/day as oxycodone / naloxone prolonged release (OXN) compared to subjects taking oxycodone prolonged release tablets alone.

Clinical Trials Register.eu (Jan 2006)

The primary objective of this study is to demonstrate that subjects with moderate to severe non malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation as measured by the bowel function index (BFI) compared to subjects taking oxycodone prolonged release tablets alone.

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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375 (Ramelteon) Tablet for Sublingual Administration (TAK-375SL Tablet) 0.1 mg and 0.4 mg as an Adjunctive Therapy in the Treatment of Acute Depressive Episodes Associated With Bipolar 1 Disorder in Adult Subjects

Clinical Trials Register.eu (Oct 2012)

To evaluate the efficacy of TAK-375SL tablet 0.1 mg and 0.4 mg once daily at bedtime (QHS) compared with placebo as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) after 6 weeks of treatment in subjects with acute depressive episodes associated with Bipolar 1 Disorder.

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A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Safety and Efficacy Study of Oral ELND005 as an Adjunctive Maintenance Treatment in Patients with Bipolar I Disorder

Clinical Trials Register.eu (Oct 2012)

To assess the efficacy of ELND005 compared to placebo as adjunctive maintenance therapy in patients with BPD I. To assess the safety and tolerability of ELND005 in BPD I patients.

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Propofol vs. Ketamin

Clinical Trials Register.eu (Jun 2012)

Better therapeutic effect of ketamin in the treatment of ECT

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A Multicenter, Open-Label, Flexible-Dose Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects with Bipolar I Disorder

Clinical Trials Register.eu (May 2012)

The primary objective of the study is to evaluate the longer term safety and tolerability of lurasidone flexibly dosed at 20, 40, 60 or 80 mg/day over a 12-week period in subjects with bipolar I disorder who have previously been treated with lurasidone.

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A randomized, double-blind, placebocontrolled, flexible-dose, parallel-group, Study of Lurasidone adjunctive to Lithium or Divalproex for the prevention of recurrence in subjects with bipolar I disorder

Clinical Trials Register.eu (Aug 2011)

To evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and/or psychotic features.

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Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication according to the the ABCB1 Gene

Clinical Trials Register.eu (Aug 2011)

To evaluate the ABCB1-genotype dependent efficacy of a quick dose-escalation strategy within 21 days of treatment with approved antidepressants that are known substrates of the P-glycoprotein, an efflux pump of the blood-brain barrier expressed by ABCB1

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A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study

Clinical Trials Register.eu (Aug 2011)

To evaluate the long-term safety, tolerability and effectiveness of lurasidone in eligible subjects who have completed a prior lurasidone extension study.

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A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Clinical Trials Register.eu (Jun 2011)

The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder. Efficacy will be assessed by the mean change from baseline in the total score from the 30-Item Inventory of Depressive Symptomatology–Clinician-Rated (IDS-C30).

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Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder

Clinical Trials Register.eu (Mar 2011)

The goal of this work is to identify genes associated with good response of bipolar patients to two commonly used mood stabilizing agents, lithium and valproate. 1. All patients will be started on lithium, then enter the maintenance phase where they will be followed for 2 years or until relapse. Those that fail lithium will be crossed over to valproic acid (VPA). Those that fail on VPA will be again crossed-over to a standardized treatment as usual (TAU) arm.

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A 6-Month, Open-Label, Flexible-Dosage (150 to 200 mg/day) Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Clinical Trials Register.eu (Jun 2010)

The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder whose most recent episode was a depressive episode.

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Study of Weekly Radiotherapy for Bladder Cancer (HYBRID)

Clinicaltrials.gov (Mar 2013)

In patients with muscle invasive bladder cancer not suitable for cystectomy or daily radiotherapy we aim to assess: - whether treatment using adaptive planning can be successfully delivered at multiple sites across the UK and results in acceptable levels of toxicity - the local tumour control rate achieved by hypofractionated weekly radiotherapy - the requirement to treat with adaptive planning.

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Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC) (NMIBC TURBT HG)

Clinicaltrials.gov (Feb 2013)

In the proposed study the investigators aim to evaluate the effect of the standard of care dose (40mg) of MMC mixed with TC-3 gel (with sustained release mechanism on the drug) on low risk recurrent NMIBC lesions and to compare our findings to instillation with the standard mode of instillation- 40mg MMC in water in order to examine our hypothesis that MMC mixed with TC-3 gel will have at least non-inferior and even superior results over the standard instillation mode

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Perioperative Chemotherapy for Patients With Locally Advanced Bladder Cancer (VESPER)

Clinicaltrials.gov (Jan 2013)

Radical cystectomy remains the gold standard treatment for invasive non metastatic transitional cell cancer (TCC) of the bladder. In contemporary series, specific survival rates are about 60 to 65% at 5 years, decreasing for locally advanced disease to 45-50% in patients with nonorgan-confined lymph-node negative tumours and to 30-35% in patients with lymph node positive tumours. Perioperative chemotherapy (adjuvant ou neoadjuvant) has been developed in order to improve these results. Thanks to randomized trials and meta-analysis, it can be concluded that perioperative chemotherapy increases overall survival with an absolute benefit of 5%, equating to a survival rate of 50% at 5 years for nonorgan-confined tumours. However, the chemotherapy administration time and the optimal chemotherapy regimen to be delivered are not yet determined. Meta-analyses have shown that the benefit is only observed for chemotherapy regimens including cisplatin. In daily management 4 to 6 cycles of gemcitabine and cisplatin are delivered since this combination has been shown to yield a similar efficacy with a better tolerance as compared to the MVAC regimen (methotrexate, vinblastine, doxorubicin and cisplatin) in the metastatic setting. As HD-MVAC has been shown to be associated with higher response rates than MVAC in bladder metastatic disease, also a better efficacy of HD-MVAC can be suspected in the perioperative setting. Investigators therefore designed a randomized phase III study to compare the efficacy of GC and HD-MVAC in term of progression-free survival in patients for whom chemotherapy has been decided, before or after radical cystectomy. Secondary endpoints include overall survival, side effects, response rate in the neoadjuvant setting and ancillary studies focusing on gemcitabine and cisplatin sensitivity. The total number of patients projected is 500. The number of patients is based on the median progression-free survival rate of 50% at 3 years observed in patients treated with GC (standard arm A) in the perioperative setting. An absolute improvement of 10% (HR=0.74) is expected with HD-MVAC (experimental arm B) with a=0.05 and b=0.20. An interim analysis is planned after the occurrence of 174 events. With an estimated uniform accrual rate of 140 patients per year for 3.5 years and exponential survival, the final analysis is expected to occur 8 years after the start of the trial.

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Effect of Macrodex versus lactated Ringer on coagulation in major surgery. A randomised clincal trial.

Clinical Trials Register.eu (Jan 2013)

The objective is to assess the coagulation competence of the fluids

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Adaptive Radiotherapy Using Plan Selection for Bladder Cancer (plan selection)

Clinicaltrials.gov (Jan 2013)

This protocol describes a Phase 2 clinical trial of online adaptive Radiotherapy, using a library of 3 dose plans corresponding to Small, Medium and Large size bladder. The procedure includes 'Common Toxicity Criteria for Adverse Effects'(CTCAE) for registration of adverse effects (baseline, every 2'nd week during RT, 2 weeks, 3, 6, 12 and 24 month after RT) as well as cineMR for intra-fractional motion (baseline and every week during RT). Patients receive standard non-adaptive RT in the first week. Delineations of the bladder on the Cone-Beam scans (CBCT) from first week of treatment are used for planning the Small and Medium size bladder plans. Large size plan are the standard non-adaptive treatment plan used for the first week of treatment. A margin of 5 mm for intra fractional movement is used.

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A Double Blind Randomised Study of Lapatinib and Placebo in Metastatic TCC of the Urothelium

National Cancer Institute (Nov 2012)

To compare progression-free survival in patients with HER1- and/or HER2-overexpressing stage IV bladder cancer who have been randomized to maintenance therapy with lapatinib ditosylate or placebo following first-line chemotherapy.

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Treatment of TA Bladder cancer with high risk of recurrence – fluorescence cystoscopy with optimized adjuvant mitomycin-c

Clinical Trials Register.eu (Aug 2012)

1) To evaluate whether the adjuvant 6-weekly optimized MMC instillation therapy is better than single immediate postoperative instillation therapy in reducing recurrences. 2) To evaluate whether the PDD-guided TUR-BT is better than the conventional white light TUR-BT in reducing recurrence, which implies evaluation of whether the effect of PDD-guided TUR-BT is additive to MMC instillation therapy

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A randomised Phase II/III study of cabazitaxel versus vinflunine in metastatic or locally advanced transitional cell carcinoma of the urothelium

Clinical Trials Register.eu (Jul 2012)

Phase II part: -efficacy of cabazitaxel compared to vinflunine in terms of improved objective response rate (ORR) of subjects with metastatic or locally advanced previously treated TCCU. Phase III part: -efficacy of cabazitaxel compared to vinflunine in terms of improved OS of subjects with metastatic or locally advanced, previously treated TCCU.

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FGFR Inhibition for Epithelial Solid Tumours: a Phase Ib trial of AZD4547 in combination with gemcitabine and cisplatin

Clinical Trials Register.eu (May 2012)

Dose Escalation Cohort: To investigate the safety, tolerability and feasibility of the novel AGC (AZD4547 with gemcitabine and cisplatin) combination in advanced non-haematological malignancies. Randomised Expansion Cohort: To obtain a preliminary indication of the relative toxicities of AGC compared to GC in locally-advanced/metastatic TCC of the urinary bladder (and other urothelial) cancers.

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Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer

National Cancer Institute (May 2012)

The use of a designed viral vector that can destroy cancer cells while leaving normal cells largely unharmed. The virus also stimulates an immunological response by producing a special factor (GM-CSF) to attract and promote the development of dendritic and T effector cells. It forms the hypothesis that this regimen may be used for people who have failed current forms of treatment and are recommended for cystectomy. It is with hope that this novel therapy will be able to delay or potentially avoid cystectomy for this patient population. Bladder instillation of this agent causes little long lasting side effects and may drastically improve the stimulation of the immune system for local cancer cell death as well as destroying those tumor cells that may have travelled to regional lymph nodes or distant organs.

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PlasmaKinetic (PK) Button Vaporization Electrode for Treatment of Bladder Tumors

National Cancer Institute (Apr 2012)

The purpose of this study is to compare the uses of two types of equipment during transurethral resection of bladder tumors (TURBT). The two types of surgical devices are: the monopolar loop electrocautery and the PlasmaKinetic (PK) Button Vaporization Electrode. These two devices do the same task but differ in the way they create electric current when removing cancerous tissue. The investigators hope to examine and compare the uses of these two surgical devices to see if any advantages do exist or whether they actually are similar. The goal of the study will be to prove similarity in outcomes between the two techniques and analyze the outcomes resulting from each case.

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A Phase II Trial of Combination Cabazitaxel and Cisplatin Chemotherapy in the Neoadjuvant Treatment of Transitional Cell Carcinoma of the Urinary Bladder

Clinical Trials Register.eu (Feb 2012)

To record the proportion of patients whose cancer responds to chemotherapy using the drugs cabazitaxel and cisplatin before surgery in the treatment of transitional cell carcinoma of the urinary bladder. This small study of about 30 patients will help to establish whether this treatment should be studied further in a larger group of patients in future.

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Single Immediate Instillation of EO9 After TURBT in Patients With Non-muscle-invasive Bladder Cancer (NMIBC)

National Cancer Institute (Feb 2012)

The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were randomized into either an EO9 or placebo group after TURBT.

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Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

National Cancer Institute (Jan 2012)

This is a single-center, prospective, randomized, controlled trial comparing two established transurethral electrical resection methods of urinary bladder tumors regarding their risk of stimulating the obturator nerve.

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Adjuvant Versus Progression-Triggered Gemcitabine Monotherapy for Locally Advanced Bladder Cancer

National Cancer Institute (Dec 2011)

To analyse time to tumor progression in patients cystectomized for locally advanced transitional cell carcinoma (TCC) of the bladder, who are not suitable for cisplatin-based chemotherapy (i.e. postoperative reduced renal function, advanced age). Patients are randomized to receive either adjuvant gemcitabine immediately after radical operation (treatment arm A) or no treatment (control arm B). Patients in the control arm are to be treated with gemcitabine as soon as tumor progression becomes evident clinically and/or radiologically.

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A Phase III randomised trial of Peri-Operative chemotherapy versus sUrveillance in upper Tract urothelial cancer

Clinical Trials Register.eu (Dec 2011)

Does chemotherapy given around the time of surgery (peri-operative) extend the amount of time for which participants remain free of recurrent disease?

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Detection of non-muscle invasive bladder cancer using PVP-Hypericin (Vidon®) fluorescence cystoscopy (Hypericin PDD)

Clinical Trials Register.eu (Jul 2011)

To collect preliminary data on the diagnostic performance of Hypericin-guided cystoscopy regarding the detection of non-muscle invasive bladder cancer . Standard, white light cystoscopy will be compared with Hypericin assisted cystoscopy (PVP-Hypericin instillation; white light followed by blue light (Hypericin PDD)) using a within-patient design by inspecting the bladder under white light first, followed by blue light.

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Multimodal Rehabilitation Program to Bladder Cancer Patients (MRPBC)

Clinicaltrials.gov (Mar 2011)

The aim of the study is to investigate the efficacy of a multiprofessional rehabilitation programme for patients with invasive bladder cancer referred to surgery.

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A phase I/II multicentric Belgian prospective novel sequential chemo-immunotherapy regimen for adjuvant treatment in non-muscle invasive bladder cancer.

Clinical Trials Register.eu (Feb 2011)

The purpose of this trial is to evaluate the toxicity for intermediate and high risk NMIBC, after complete transurethral resection of all papillary tumours, of an intravesical sequential treatment combining MMC (mitomycine c) 40mg and BCG (Bacillus Calmette-Guérin) 1/10th , 1/6th and 1/4 dose. MMC will act as an apoptosis inductor and BCG as a recruiter of immune effectors, among which DCs. We then hope to obtain, in addition to the classical response to MMC, an immune response with a presentation of TAA in association with MHC class I able to induce a specific CTL-mediated response directed against the tumour. The study is designed to evaluate the safety and severity of acute side effects of the treatment.

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Phase III Randomized Study of Standard Versus Extended Pelvic Lymphadenectomy During Radical Cystectomy in Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder

National Cancer Institute (Oct 2010)

To compare disease-free survival (DFS) of patients with muscle-invasive urothelial carcinoma of the bladder undergoing radical cystectomy with extended pelvic lymph node dissection (PLND) or standard pelvic lymphadenectomy.

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Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder Cancer

Clinicaltrials.gov (Sep 2010)

This randomized phase II trial is studying standard surgery to see how well it works compared with minimal-access surgery in treating patients with bladder cancer.

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Comparison Study of Narrow Band Imaging Versus White Lite Resection in Patients With Bladder Tumors/Cancer

Clinicaltrials.gov (Aug 2010)

The purpose of this study is to compare the recurrence rate at 1 year following Narrow Band Imaging and trans-urethral resection of bladder tumor with White Light and TURB in patients with non-muscle invasive bladder cancer.

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Phase II trial evaluating combined image guided radiotherapy with Panitumumab (Vectibix®) in patients with muscle invasive transitional cell carcinoma of the bladder

Clinical Trials Register.eu (May 2010)

Primary objective is to evaluate the safety of combined radiotherapy with Panitumumab in bladder preservation in invasive bladder cancer.

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Study of the Efficacy of Maintenance Therapy Using Uracil-tegafur (UFT) or Bacille Calmette-Guerin (BCG) for the Prevention of Recurrences of Superficial Bladder Cancer (EMBARK Study)

National Cancer Institute (Mar 2010)

The purpose of this prospective randomized controlled study is to prove the non-inferiority of UFT maintenance therapy to BCG maintenance therapy for preventing recurrences of superficial bladder cancer.

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Prospective multicentric evaluation of a bladder preservation strategy using a combination of neoadjuvant chemotherapy with intensified MVAC (Méthotrexate + vinblastine + adriamicine + Cisplatine) and optimal bladder transurethral resection in patients with a localized muscle infiltrative urothelial carcinoma (protocol ReChiVe)

Clinical Trials Register.eu (Nov 2009)

The 5 years bladder preservation rate in patients with a localized infiltrative bladder treated with a double optimal transurethral bladder resection (TURB) combined with a neoadjuvant chemotherapy.

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ONCOFID-P (Paclitaxel-hyaluronic acid) in the intravesical therapy of patients with non-muscle invasive cancer of the bladder. A phase II marker lesion study

Clinical Trials Register.eu (Oct 2009)

To assess, at control visit (V8), the ablative activity of intravesical administration of Oncofid-P-B on a papillary marker tumor on patients suffering from multiple recurrent Ta G1-G2 papillary cancer of the bladder after 6 weeks of weekly study drug administration, through number and percentage of patients with Complete Response.

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Pilot study of Lapatinib (Tyverb®) in néoadjuvant treatment for patients with locally bladder carcinoma before cystectomy

Clinical Trials Register.eu (Sep 2009)

The primary objective of the study is to evaluate the effect at a molecular level, of 3 weeks of neoadjuvant lapatinib, in locally advanced muscle-invasive transitional cell carcinoma of the bladder. A comparison of tissue from the original biopsy and cystectomy after lapatinib will allow this to occur. This effect will be evaluated by studying proliferation and apoptotic markers as well as the phosphorylation of proteins which are components of the egf signalling pathway.

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Phase II/III Randomized Study of Lapatinib Ditosylate in Patients With HER1- and/or HER2-Overexpressing Stage IV Transitional Cell Carcinoma of the Bladder

National Cancer Institute (Jul 2009)

Compare progression-free survival in patients with HER1- and/or HER2-overexpressing stage IV bladder cancer who have been randomized to maintenance therapy with lapatinib ditosylate or placebo following first-line chemotherapy.

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Evaluation of Non-Invasive Assay(s) for the Detection of Bladder Cancer

Clinicaltrials.gov (Mar 2009)

The purpose of this study is to determine if analysis of DNA and protein material found in urine will be useful in the detection of bladder cancer progression. This analysis may be helpful to determine if how a particular cancer will act regarding remission and recurrence.

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Genetic Susceptibility to Bladder Cancer

Clinicaltrials.gov (Feb 2009)

This clinical research study will identify biologic and lifestyle factors which increase a person's risk of developing specific cancer. We propose to conduct a case-control study examining interindividual differences in susceptibility to tobacco carcinogenesis as predictors of bladder cancer risk. We will measure susceptibility to tobacco carcinogenesis and this will include studies of the genetic modulation of carcinogen activation and detoxification and of chromosome sensitivity to tobacco mutagens.

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A Phase II single-arm trial to evaluate cisplatin and gemcitabine chemotherapy in combination with sunitinib for first-line treatment of patients with advanced transitional carcinoma of the urothelium.

Clinical Trials Register.eu (Oct 2008)

The objective of this trial is to assess whether the addition of sunitinib to standard cisplatin / gemcitabine (CG) cancer chemotherapy improves outcome for participants with advanced cancer of the urinary system (urothelial cancer). The primary objective is to assess the activity, safety and feasibility of using the 3−drug combination (SCG) in patients with advanced transitional cell carcinoma of the urothelium. The primary outcome measure is progression−free survival (PFS) at 6 months from date of enrolment. This is the proportion of participants who are alive at 6 months without disease progression, according to RECIST (Response Evaluation Criteria In Solid Tumours).

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Phase III Randomized Chemoprevention Study Of Selenium On The Recurrence Of Non-Invasive Bladder Cancer

Clinical Trials Register.eu (Sep 2008)

The primary objective of the study is to determine the effect of selenium, in addition to standard care, on the recurrence of bladder cancer.

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Quality of Life in Patients With Bladder Cancer

Clinicaltrials.gov (Aug 2008)

The purpose of this study is to learn about the quality of life of people living with bladder cancer. We are interested in learning about how the treatments for bladder cancer affect people. We plan to use the findings from this study to help doctors provide better care and information to patients with bladder cancer.

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Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer

Clinicaltrials.gov (Aug 2008)

This randomized phase III trial is studying selenium to see how well it works compared with a placebo in preventing cancer recurrence in patients with bladder cancer.

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A Phase 2, Single-Arm Study of Pralatrexate in Patients with Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder

Clinical Trials Register.eu (Mar 2008)

To determine the objective response rate (CR + PR) for pralatrexate with concurrent vitamin B12 and folic acid supplementation in the treatment of patients with advanced or metastatic relapsed TCC (Transitional Cell Carcinoma) of the urinary bladder.

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Genetic Susceptibility to Tumor Recurrence and Progression in Patients With Non-Muscle Invasive Bladder Cancer

Clinicaltrials.gov (Dec 2007)

The purpose of the study is to see if we will be more able to tell what the risk is for bladder cancer to reoccur or worsen when genetics and risk factors are examined along with the stage and grade of the tumor. Superficial bladder cancer is a cancer that does not grow into the muscle layer of the bladder wall. Even though it is a superficial cancer, this type of cancer tends to come back after being treated and is often more aggressive when it returns. We already know, that the "stage" or how deeply the tumor grows into the bladder wall and the "grade" or how fast the tumor grows affect whether the tumor will come back or get worse over time. Now we use information about the stage and grade of your tumor to decide how to treat the tumor and how often you should be checked after the treatment is over. However, this has not been very reliable, because each person has unique genetic characteristics and other factors that are likely to affect what happens to the tumor over time. For instance, we know the risk for developing a cancer may be affected by your surroundings and other factors such as what you eat, the type of habits you have such as smoking, and the type of job you have, but not everyone exposed to the same risk factors gets a cancer. We believe this is due to unique genetic characteristics in each person which may help their body fight cancer.

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Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer.

Clinical Trials Register.eu (Nov 2007)

To compare Overall Survival (OS) of patients administered Larotaxel in combination with cisplatin for the treatment of locally advanced/metastatic urothelial tract or bladder cancer

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A phase II/III, randomised, two-arm comparison of maintenance lapatinib versus placebo after firrst-line chemotherapy in patients with HER1 and/or HER2 over expressing locally advanced or metastatic bladder cancer.

Clinical Trials Register.eu (Aug 2007)

The main objective of the study is to compare progression-free survival (PFS) in patients with HER1 and/or HER2 over expressing stage IV bladder cancer who have been randomised to maintenance therapy with lapatinib or placebo following first-line chemotherapy

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Pharmacokinetical-clinical study of intravescical gemcitabine in patients with marker lesion of superficial transitional cell carcinoma of the bladder

Clinical Trials Register.eu (Jun 2007)

The aim of this study is to define the optimal values of the next parameters for the intravescical administration of gemcitabine 20000 mg: pH of the instilled solution: pH 2.7-3.2 (unbuffered solution) or pH 5.5 (buffered solution) dwell time: 1 hour or 2 houres concentration of gemcitabine (20 mg/ml or 40 mg/ml)

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Oral Celecoxib combined with BCG instillation therapy in treatment of carcinoma in situ (CIS), TaG3 and T1 disease of urinary bladder

Clinical Trials Register.eu (Oct 2006)

The aim of this study is to assess the efficacy of Oral Celecoxib combined with BCG instillation therapy in treatment of carcinoma in situ (CIS), TaG3 and T1 disease of urinary bladder

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Hyperthermia Treatment in Conjunction With Mitomycin C Versus BCG for Superficial Bladder Cancer

National Cancer Institute (Oct 2006)

The study is a randomized controlled study, designed to test the efficacy and safety of a new treatment modality for the prevention of tumor recurrence in superficial bladder cancer.

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A randomised phase III placebo-controlled trial evaluating the addition of celecoxib to standard treatment of transitional cell carcinoma of the bladder

Clinical Trials Register.eu (Jul 2006)

The main objectives of the trial are to determine if the addition of the oral COX-2 inhibitor celecoxib to standard therapy is more effective in terms of disease recurrence at 3 years than standard therapy alone for the treatment of superficial TCC of the bladder at high risk of recurrence. To determine if the addition of the oral COX-2 inhibitor celecoxib to standard therapy is more effective in terms of disease recurrence at 3 years than standard therapy alone for the treatment of superficial TCC of the bladder at intermediate risk of recurrence.

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Phase II Open Label, Non-randomized Study of Sorafenib and Everolimus in Relapsed and Non-resectable Osteosarcoma (SERIO)

Clinicaltrials.gov (Mar 2013)

This is a trial for patients affected by metastatic or relapsed osteosarcoma which progressed after first or further line treatments. In this trial, all patients will be treated until progression or unacceptable toxicity with sorafenib and everolimus. The treatment with sorafenib and everolimus aimed to obtain a 50% rate of patients free from further progression of the disease after 6 months from study entry.

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Osteosarcoma and Ewing Sarcoma Treatment Response Assessment With Functional MRI Imaging in Children and Young Adults (FUBEO)

Clinicaltrials.gov (Jan 2013)

The purpose of the study was to investigate whether functional MRI imaging (diffusion weighted imaging) is useful for monitoring the therapeutic response of bone sarcomas in children and young adults. All patients will be scanned before, during and after chemotherapy. The findings on MRI will be correlated with histological finding after surgery. Second purpose : to define apparent diffusion coefficient value of the bone sarcoma. Third purpose : to try define prognostic factors, to investigate if there is a correlation between early treatment response and outcome.

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A multicenter, prospective, randomized clinical trial for patients with relapsed osteosarcoma

Clinical Trials Register.eu (Aug 2012)

To compare the efficacy and tollerability of two chemotherapeutic regimens (either Cyclophosphamide+ Etoposide or high dose Ifosfamide) currently used to treat relapsed Osteosarcoma patients

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Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastasis

Clinical Trials Register.eu (Jun 2012)

To assess acute and long-term safety and overall survival in patients with castration-resistant (hormone-refractory) prostate cancer.

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Phase II multicentric and prospective trial with gemcitabine and rapamycin in second line of metastatic osteosarcoma

Clinical Trials Register.eu (Apr 2012)

Analyze progression free survival (PFS), measured as SLP index at 4 months, in patients with metastatic osteosarcoma who have previously received the more active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide) and are in metastatic progression or cannot be operated.

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Pharmacokinetics and Pharmacodynamics of Doxorubicin in Children, Adolescents and young adults with Newly Diagnosed Osteosarcoma, Ewing Family of Tumours and Hodgkin Lymphoma A Multi-Institutional Cross-Discipline Non-Therapeutic Study

Clinical Trials Register.eu (Mar 2012)

To evaluate the effect of gender on the pharmacokinetics (PK) of doxorubicin in AYA* patients with newly diagnosed: -Ewing family of tumours (EFT)** -Osteosarcoma (OS); or -Hodgkin lymphoma (HL) *AYA is defined as young people who have entered puberty (Tanner stage ≥2) or are pubertally mature, regardless of whether they are being treated on an adult chemotherapy regimen or a children’s chemotherapy regimen. **EFT includes Ewing’s sarcoma of bone, extra-osseous Ewing Sarcoma, and PNET (primitive neuroectodermal tumour) outside the central nervous system.

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Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma

Clinical Trials Register.eu (Dec 2011)

This trial will be a pilot study to find out if zoledronic acid improves the response to chemotherapy in high grade osteosarcoma.

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ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma

Clinical Trials Register.eu (Dec 2011)

The main objective of the study is to assess the survival in patient with non metastatic osteosarcoma of the extremities treated with different chemotherapy protocols, according to the expression of ABCB1/P-glycoprotein

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ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma (ISG/OS-2)

Clinicaltrials.gov (Oct 2011)

The main objective of the study is to assess the survival in patient with non metastatic osteosarcoma of the extremities treated with different chemotherapy protocols, according to the expression of ABCB1/P-glycoprotein

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Open-Label Access Protocol of Denosumab for Subjects with Advanced Cancer

Clinical Trials Register.eu (Aug 2011)

To facilitate the access of denosumab for subjects with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale

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Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy

National Cancer Institute (Oct 2010)

The purpose of this study is to find out which way of giving high-dose radiation works best for treatment of cancer that has spread to bone, the spine, soft tissue, or lymph nodes. This study will look at the effects, good and/or bad, of giving 27 Gy in three fractions (3 days) or 24 Gy in one fraction (1 day) using image-guided intensity-modulated radiotherapy (IG-IMRT). IG-IMRT is radiation that is given directly to the cancer site and reduces the exposure to normal tissue. Currently there are no studies that compare the effects of giving radiation in either hypofractionated doses (higher total doses of radiation spread out over several treatment days) or a single-fraction dose (entire radiation dose given in one treatment session).

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An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab for Prolonging Bone Metastasis-Free Survival in Men with Hormone-Refractory Prostate Cancer

Clinical Trials Register.eu (Sep 2010)

To describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab

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Surveillance Study of Patients With Newly Diagnosed Osteosarcoma

Clinicaltrials.gov (Sep 2010)

This study is an observational safety surveillance study designed to prospectively assess patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice

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Study Comparing the Safety and Effectiveness of Magnetic Resonance Guided Focused Ultrasound (MRgFUS) and External Beam Radiation (EBRT) for Treatment of Metastatic Bone Tumors and Multiple Myeloma

Clinicaltrials.gov (Mar 2010)

The goal of this study is to collect comparative data on safety and efficacy of MR Guided Focused Ultrasound and External Beam Radiation for treatment of metastatic bone tumors or multiple myeloma.

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Effect of aminobisphosphonates and statins on circulating Vy9Vd2-T cells

Clinical Trials Register.eu (Mar 2010)

To study (in patients who have an indication for treatment with an intravenous aminobisphosponate because of bone metastases of a malignant tumor) the effects of aminobisphophonate treatment on the phenotype and function on circulating Vy9Vd2-T cells and to determine whether these effects are inhibited by simultaneous treatment with statins.

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Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System

Clinicaltrials.gov (Mar 2010)

The goal of this prospective, non-randomized, single-arm, phase 2 study is to evaluate the safety and effectiveness of this treatment using this ExAblate conformal system in the treatment of pain resulting from metastatic bone tumors Up to Fifty (50) patients will be recruited in this feasibility study. The treated patients will be followed for 3-Months post their last treatment, patients with the standard contraindications to MRI examination, such as implanted metal devices (pacemakers, etc.), will be excluded.

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Genomic Analysis of Pediatric Bone Tumors

Clinicaltrials.gov (Jan 2010)

To determine whether gene expression analysis of primary tumor samples before and after chemotherapy are predictive of long-term survival in pediatric patients with bone sarcomas (Ewings sarcoma (ES) and Osteosarcoma(OS)).

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An open-label Phase IIa, non-randomised, study of Alpharadin in breast cancer patients with bone dominant disease who are no longer considered suitable for endocrine therapy

Clinical Trials Register.eu (Jul 2009)

To investigate if multiple intravenous injections of Alpharadin have any clinically relevant effect on bone markers in breast cancer patients with bone dominant disease who have progressed on endocrine therapy and are no longer considered suitable for endocrine therapy.

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Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma

Clinicaltrials.gov (May 2009)

The purpose of this study is to collect and store samples of blood and tumor tissue from patients with osteosarcoma.

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An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab in the Treatment of Bone Metastases in Subjects with Advanced Cancer or Multiple Myeloma

Clinical Trials Register.eu (May 2009)

To describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.

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A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung

National Cancer Institute (Sep 2008)

The purpose of this study is to determine how long patients who undergo complete surgical removal of recurrent osteosarcoma in the lung will remain free of cancer after taking Saracatinib compared to patients taking placebo (a sugar pill).

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A Phase III Study to Assess the Tolerability and Efficacy of MK-0822 (Odanacatib) in Reducing the Risk of Bone Metastases and Prolonging Disease-Free Survival in Women with Breast Cancer

Clinical Trials Register.eu (Jul 2008)

The main objectives of the trial are: To assess the effect of treatment with MK-0822 5 mg once daily on the risk of developing a first bone metastasis (first disease recurrence) compared to placebo. To assess the effect of treatment with MK-0822 5 mg once daily on disease-free survival compared to placebo. To assess the effect of treatment with MK-0822 5 mg once daily in a subset of 250 patients on lumbar spine, total hip, femoral neck, trochanter and total body bone mineral density (BMD) compared to placebo. To assess the tolerability of treatment with MK-0822 5 mg once daily compared to placebo

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Development of Indices Predicting Response to Pre-operative Chemotherapy in Osteosarcoma Patients

Clinicaltrials.gov (May 2008)

The purpose of this study is to develop indices predicting response to pre-operative chemotherapy in osteosarcoma patients. Histologic response to pre-operative chemotherapy is very important for the ultimate outcome of osteosarcoma patients. Conventional methods such as CT or MRI evaluating tumor response to chemotherapy is not so efficient in tumors like osteosarcoma. Instead, the investigators will test whether blood TGF-b1 levels, PET/CT findings, MRS findings as well as the level of NF-kB expression in tumor tissues can predict chemotherapy response in osteosarcoma.

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A double-blind, randomised, multiple dose, Phase III, multicentre study of Alpharadin in the treatment of patients with symptomatic hormone refractory prostate cancer with skeletal metastases.

Clinical Trials Register.eu (Mar 2008)

To compare, in patients with symptomatic HRPC and skeletal metastases, the efficacy of best standard of care plus Alpharadin versus best standard of care plus placebo, with the primary efficacy endpoint being overall survival (OS).

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A Phase II, Randomised, Open-label, Pilot Study to Evaluate the Safety and the Effects on Bone Resorption of AZD0530 in Patients with Prostate Cancer or Breast Cancer with Metastatic Bone Disease

Clinical Trials Register.eu (Feb 2008)

To estimate the effect of AZD0530 plus standard of care (SoC) compared with zoledronic acid plus SoC on bone resorption by assessment of serum beta Cterminal cross-linking telopeptide of Type I collagen (βCTx)

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Inheritance of Osteosarcoma & Paget's Disease Through Chromosome 18: Examination of Osteosarcoma Tissue Samples From Two Family Members for Loss of Heterozygosity in the Chromosome 18 Region, Genetically Linked With Paget's Disease of Bone

Clinicaltrials.gov (Feb 2008)

Researchers have previously demonstrated loss of heterozygosity in a region on chromosome 18q, associated with osteogenic sarcomas in bone affected by Paget's disease. The loci used in this study are specifically described by those authors as showing loss of heterozygosity in 6 of 7 affected families.

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Open label study to establish the efficacy of intravenous loading doses of Ibandronate 6 mg in patients with lung cancer and skeletal metastased experiencing moderate to severe bone pain.

Clinical Trials Register.eu (May 2007)

The primary objective is to establish the efficacy of ibandronic acid in patients with lung cancer and painful metastatic bone disease and pain responses over a 7 day period.

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Phase III Randomized Study of Combination Chemotherapy With or Without Zoledronic Acid in Patients With Osteosarcoma

National Cancer Institute (May 2007)

Compare the progression-free survival of patients with osteosarcoma treated with combination chemotherapy with or without zoledronic acid.

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A Phase II Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Women with Breast Cancer and Established Bone Metastases (MBD)

Clinical Trials Register.eu (Sep 2006)

Main objective: To assess the safety, tolerability, and biochemical efficacy (changes in urinary NTx) of MK-0822 in women with breast cancer and MBD. Secondary objectives: To assess the efficacy of MK-0822 on additional biochemical parameters and its pharmakokinetic properties

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A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma

Clinical Trials Register.eu (Jul 2006)

To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with advanced cancer and bone metastases (or lytic bone lesions from multiple myeloma). SRE is defined as pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.

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A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Breast Cancer.

Clinical Trials Register.eu (May 2006)

To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal related event (SRE). SRE is defined as pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression in subjects with advanced breast cancer and bone metastases.

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A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men with Hormone-Refractory Prostate Cancer

Clinical Trials Register.eu (Feb 2006)

To compare the treatment effect of AMG 162 with placebo on prolonging bone metastasis-free survival in men with hormone refractory (androgen independent) prostate cancer who have no bone metastasis at baseline.

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Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery (IMAGER)

Clinicaltrials.gov (Feb 2013)

The investigators hypothesize that the rate of radiologically complete resections of contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to surgeries aided by 5-ALA induced fluorescene alone.

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Risk Factors of Complications Regarding Patients Undergoing Brain Tumour Neuro-surgery (Cranioscore).

Clinicaltrials.gov (Feb 2013)

Patients undergoing a brain tumour neurosurgery with craniotomy may present rare but lifethreatening post-operative complications. There are currently no strong recommendations to help the clinician in an attempt to properly hospitalise these patients after their intervention (Neuro-ICU, ICU,surgical ward). Determining risk factors of post-operative complications could optimise resources. Therefore hospitalisation in Neuro-ICU would be mandatory in only a little number of patients.

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Presurgical Language Mapping With fMRI: Comparison of BOLD and fASL Techniques (MALTA)

Clinicaltrials.gov (Feb 2013)

One of the aim of the neurosurgical treatment of brain tumor is to offer the maximal resection with the minimal neurological risk. The presurgical mapping of eloquent areas with functional magnetic resonance imaging (fMRI) is helpful to plan the surgery. BOLD fMRI is now the gold standard to map language areas. However, BOLD signal is diminished near the brain tumor. It is now possible to detect cortical activation with arterial spin labeling (ASL) techniques, detecting variations of perfusion during an activation paradigm (fASL), fASL could be interesting to detect eloquent areas near a brain tumor.

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iMRI-guided Brain Biopsies

Clinicaltrials.gov (Jan 2013)

The aim of the study was to assess the safety and effectiveness of stereotactic brain tumour biopsy (STx biopsy) guided by low-field intraoperative MRI (iMRI) in comparison with its frameless classic analogue based on a prospective randomized trial.

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Re-irradiation of High Grade Gliomas: a Quality of Life Study

Clinicaltrials.gov (Oct 2012)

Patients with a high grade glioma have an increasing overall survival and progression free survival after initial treatment. Because of a better performance status these patients are more often eligible for re-treatment with for example radiotherapy. However, to date only a few prospective studies on re-irradiation of gliomas exist and very little is known about the effects of re-irradiation on quality of life and cognition. This trial is designed to longitudinally establish the effects of re-irradiation on quality of life, cognition and physical performance in patients with a high grade glioma. Based on the currently available information the investigators hypothesize that quality of life after re-irradiation can be kept stable until further tumour progression.

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Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging (TeDi-C2)

Clinicaltrials.gov (Sep 2012)

This study will examine the use of a variation of standard magnetic resonance imaging (MRI) called diffusion tensor MRI (DT-MRI), in order to evaluate the peripheral white matter infiltration of high grade brain tumors. Organized architecture is destroyed once brain tumor cells are infiltrating surrounding tissue. The infiltrated tissue is then isotropic (or less anisotropic). DT-MRI can assess anisotropy after datasets post treatment. Primary outcome is to find if a correlation exists between GA (generalized anisotropy) and the infiltration percentage of stereotactic peritumoral biopsies.

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Phase-1 Study of Folinic Acid to Modulate MGMT Gene in Glioblastoma (FOLAGLI)

Clinicaltrials.gov (Sep 2012)

O6-méthylguanine méthyltransférase (MGMT) is the main repair gene after DNA lesion induced by Temozolomide in combination with radiation therapy of Glioblastoma (GBM) in Stupp.R et al published regimen. In preclinical models, it has been demonstrated that MGMT methylation (which is silencing the DNA repair process) is achievable by folic acid. About half of the patients with operated GBM have an un-methylated MGMT gene status and therefore a poorer prognosis. A phase-1 dose escalation study is proposed with pharmacologic doses of folinic acid in combination with temozolomide and radiotherapy of operated GBM.

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NOA-12: BIBF1120 and R-RT in Glioblastoma

Clinicaltrials.gov (Jul 2012)

Patients with glioblastoma at first or second progression who have failed standard treatment that must have included radiochemotherapy with temozolomide and who are a candidate for a reirradiation can be included into the trial. In the phase I part the minimal tolerated dose (MTD)of BIBF 1120 in combination with radiotherapy will be investigated. Subjects in phase II will be randomised to receive reirradiation alone or reirradiation + 2 x MTD BIBF1120.

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A randomised phase 2 trial investigating the additional benefit of hydroxychloroquine(HCQ) to short course radiotherapy (SCRT) in patients aged 70 years and older with high grade gliomas (HGG)

Clinical Trials Register.eu (Jul 2012)

To examine the effect on one year survival of giving hydroxychloroquine (HCQ) with short course radiotherapy (SCRT) to high grade gliomas (HGG) patients aged ≥ 70 years

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A Phase III clinical trial evaluating DCVax®-L, autologous dendritic cells (DC) pulsed with tumor lysate antigen for the treatment of glioblastoma multiforme (GBM)

Clinical Trials Register.eu (Jul 2012)

The primary objective of this study is to compare progression free survival (PFS) between patients in the DCVax-L cohort and patients in the placebo cohort

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MRI-perfusion and FLT- and FET-PET during bevacizumab monotherapy for patients with recurrent Glioblastoma Multiforme

Clinical Trials Register.eu (Jun 2012)

Determine changes in tumor perfusion parameters defined by perfusion MRI and changes in tumor proliferation defined by FLT- and FET-PET

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An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma (The “ACT IV” Study)

Clinical Trials Register.eu (May 2012)

The primary objective of the study is to confirm that the addition of rindopepimut/GM-CSF to adjuvant temozolomide improves overall survival in patients with newly diagnosed, resected, EGFRvIII positive glioblastoma who have undergone gross-total resection.

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A randomized, double-blind, placebo-controlled, multicenter phase II study evaluating the efficacy and safety of onartuzumab in combination with bevacizumab or onartuzumab monotherapy in patients with recurrent glioblastoma

Clinical Trials Register.eu (Apr 2012)

• To evaluate the efficacy of onartuzumab + bevacizumab relative to placebo + bevacizumab as measured by investigator-assessed progression-free survival (PFS) • To evaluate the efficacy of onartuzumab + bevacizumab relative to placebo + bevacizumab as measured by investigator-assessed PFS in the subgroup of patients with Met-positive (Met+) glioblastoma

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A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate plus Lomustine Therapy compared to Lomustine Monotherapy in Patients with Recurrent Glioblastoma

Clinical Trials Register.eu (Jan 2012)

Overall Survival

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Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy

National Cancer Institute (Dec 2011)

The purpose of this study is to investigate the correlation of SV2A expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with their clinical response to levetiracetam.

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A phase I/II, randomized, open-label, multi-centre study of BIBF1120 + reirradiation (R-RT) versus reirradiation in the treatment of patients with first or second progression of glioblastoma

Clinical Trials Register.eu (Nov 2011)

Phase I - Maximal tolerated dose of BIBF1120 in combination reirradiation - Safety and tolerability of BIBF1120 in conjunction with radiotherapy - Pharmacokinetic studies in plasma and cerebrospinal fluid Phase II Primary objective: - 6 months rate of progression-free survival (PFS6)

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Phase II pilot, prospective, open label, multicenter Clinical Trial, to evaluate the safety and efficacy of PF299804, a pan-HER irreversible inhibitor, in patients with recurrent glioblastoma with EGFR amplification or presence of EGFRvIII mutation

Clinical Trials Register.eu (Nov 2011)

To assess progression-free survival (PFS) at six months (PFS6m) in patients with recurrent glioblastoma with EGFR amplification or presence of EGFRvIII mutation.

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FLT-PET Imaging of Brain Tumors in Children

Clinicaltrials.gov (Oct 2011)

Brain tumors are the leading cause of death from solid tumors in children. Tumor imaging is important in the management of these tumors, but current imaging methods have limitations in providing the necessary information for optimal treatment of these patients. The goal of this study is to evaluate the potential utility of positron emission tomography (PET) with 3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) in the medical management of brain tumors in children.

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Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT

National Cancer Institute (Oct 2011)

The purpose of this study is to characterize tumour uptake of somatostatin analog 68Ga-DOTATOC in patients with either primary or recurrent malignant glioma. The investigators hypothesis is that some primary and recurrent malignant gliomas overexpress SST2 receptor which can be imaged with 68Ga-DOTATOC PET/CT. The investigators also hypothesize that tumor uptake of 68Ga-DOTATOC correlates with immunohistochemically determined SST2 receptor status of the tumor specimen.

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Short Course vs. Standard Course Radiotherapy in Elderly and/or Frail Patients With Glioblastoma Multiforme

National Cancer Institute (Oct 2011)

This is a multi-centre prospective, non-inferiority trial. Patients will be randomized to two treatment groups in a 1:1 ratio and will be stratified by age, Karnofsky Performance Status and extent of the surgical resection. This study will assess the effect of a one-week radiotherapy regimen in comparison with a three-week radiotherapy regimen on the survival of elderly and/or frail patients with glioblastoma multiforme (Frail: ≥>50 years old and with a KPS of 50% or less50%-70%; Elderly and frail: ≥65 years and with a KPS of 50% - 70%; Elderly: ≥65 years and with a KPS of 80% - 100%).

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More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery

Clinicaltrials.gov (Sep 2011)

The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time. When the investigators remove the tumor from your brain, it is important that they remove all of the tumor and not remove parts of normal brain. Sometimes this can be difficult because the tumor can look like normal brain. In some brain tumors, 5-ALA can make the tumors glow red under blue light.

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An open-label, single-arm, phase II, multicenter study to evaluate the efficacy of vemurafenib in metastatic melanoma patients with brain metastases

Clinical Trials Register.eu (May 2011)

To evaluate the efficacy of vemurafenib using Best Overall Response Rate (BORR), as assessed by an Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST, v1.1) in the brain of metastatic melanoma patients with previously untreated brain metastases

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An open-label, Phase I/IIa, dose escalating study of 2B3-101 in patients with solid tumors with or without brain metastases.

Clinical Trials Register.eu (Apr 2011)

To assess the safety and tolerability of 2B3-101 when administered intravenously (IV) in patients with solid tumors with our without brain metastases in order to determine the Maximum Tolerated Dose (MTD).

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Electrochemotherapy as a palliative treatment for brain metastases

Clinical Trials Register.eu (Nov 2010)

Primary endpoint is safety of the trial treatment, electrochemotherapy for brain metastases. This is evaluated by regularly registrations of adverse events (serious adverse events and adverse events) using the CTCAE criteria version 4.0.

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Phase III Randomized Study of Adding Vincristine Sulfate, Topotecan Hydrochloride, and Cyclophosphamide to Standard Chemotherapy in Patients With Non-Metastatic Extracranial Ewing Sarcoma

National Cancer Institute (Oct 2010)

The primary objective of this trial is to test the effect of the combination of vincristine, cyclophosphamide, and topotecan (VTC) added to the standard 5-drug chemotherapy interval-compressed backbone on event-free survival (EFS) and overall survival of children and young adults with Ewing sarcoma.

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Efficacy and Safety Study of Lomustine/Temozolomide Combination Therapy vs. Standard Therapy for Glioblastoma Patients

National Cancer Institute (Jun 2010)

The prognosis of patients with newly diagnosed glioblastoma is dismal despite recent therapeutic improvements Using standard therapy with temozolomide (TMZ) and radiotherapy (60 Gy), the median overall survival time (mOS) is 14.6 months (Stupp et al., 2005). Since in a previous non-randomized bicentric phase II trial, primary combination chemotherapy with lomustine (CCNU) and TMZ was highly effective (mOS 23 months; UKT-03 trial; Herrlinger et al., 2006; Glas et al., 2009) the proposed trial further investigates the efficacy of CCNU/TMZ in a randomized multicenter phase III setting against standard therapy. In case the projected phase III trial confirms the phase II data, CCNU/TMZ combination would be significantly better than TMZ monotherapy and would thus be the new standard treatment for newly diagnosed GBM patients with a methylated MGMT promotor. Thus, this trial has the potential to profoundly change the standard therapy of this most aggressive brain tumor. Since in the previous trial only patients with a methylated MGMT (mMGMT) promoter had a benefit from CCNU/TMZ (mOS in the mMGMT group 34 months, in the non-mMGMT group 12.5 months; Glas et al., 2009) while patients with a non-methylated MGMT did not have any benefit, the trial is restricted to mMGMT patients.The CeTeG trial randomizes in a 1:1 fashion newly diagnosed GBM patients (18-70 years) for either standard TMZ therapy (concomitant and 6 courses à 4 weeks of adjuvant TMZ therapy) or experimental CCNU/TMZ therapy (6 courses à 6 weeks). Both arms include standard radiotherapy (RT) of the tumor site (30 x 2 Gy). Assuming that CCNU/TMZ therapy increases the median overall survival (mOS) from 48.9% (standard TMZ) to 70% (CCNU/TMZ; 75% in the previous phase II trial, Glas et al., 2009), 2 x 68 patients have to be accrued. Patients will be accrued over 24 months and each patient will be followed for at least 24 months adding up to a total minimal duration of the time from first patient in until the end of the follow-up time of 48 months. The primary endpoint is overall survival; secondary endpoints include progression-free survival, response rate, acute and late toxicity, and quality of life.

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BIRN (Biomedical Informatics Research Network) Resources Facilitate the Personalization of Malignant Brain Tumor (CONDR)

Clinicaltrials.gov (May 2010)

The goal of this study is to create a comprehensive database of Magnetic Resonance Imaging (MRI) and of pathology for patients with brain tumors. Both standard, advanced, and research MRI components may be included, these will be analyzed in comparison with pathology results if/when a biopsy is obtained, and also used to predict/evaluate responses to therapy. This study will create a database of de-identified MRI images which include these techniques so that brain tumors can be studied over time (longitudinally) in an organized manner.

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Assessment of Sleep Complaints in Brain Tumor Survivors

Clinicaltrials.gov (Apr 2010)

Survivors of pediatric brain tumors are noted to have increased rates of excessive daytime sleepiness.However, very little data are available regarding the specific sleep disturbances of pediatric brain tumor survivors.Children ages 8 to 18 years of age who are active patients in the After Completion of Therapy Clinic and are at least 5 years from diagnosis and at least 2 years post treatment or observation only for a brain tumor will be targeted to assess the prevalence of sleep complaints.

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Lapatinib and Whole Brain Radiotherapy for patients with brain metastases from lung and breast tumors. A phase II study of the Hellenic Cooperative Oncology Group (HeCOG).

Clinical Trials Register.eu (Oct 2009)

The main objective of the study is to measure the response rate in brain as assessed by volumetric analysis of brain MRI.

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Phase III Randomized Study of Radiotherapy With Versus Without Temozolomide in Patients With Symptomatic or Progressive Low-Grade Gliomas

National Cancer Institute (Sep 2009)

Primary Objectives: 1. To determine whether the addition of temozolomide to fractionated radiotherapy improves the progression-free survival (PFS) of patients with symptomatic or progressive low-grade gliomas. 2. To determine whether the addition of temozolomide to fractionated radiotherapy improves the median overall survival (OS) of these patients.

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The effect of drugs used to reverse neuromuscular blockade on intra-cranial pressure

Clinical Trials Register.eu (Sep 2009)

To determine whether sugammadex (Bridion) or neostigmine methylsulphate have any effect on intracranial pressure following elective neurosurgery

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A single arm, open-label trial assessing the effect of Capecitabine (Xeloda®) on progression-free survival rate at four months in breast cancer patients with CNS progression after whole brain radiotherapy

Clinical Trials Register.eu (Jul 2009)

To evaluate the efficacy of capecitabine in terms of Progression Free Survival (PFS) rate at 4 months, reviewed by centralized independent expert, in treatment of brain metastases secondary to breast cancer in patients with CNS progression after whole brain radiotherapy (WBRT).

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Radiation therapy and concurrent plus adjuvant Temsirolimus (CCI-779) versus chemo-irradiation with Temozolomide in newly diagnosed glioblastoma without methylation of the MGMT gene promoter – a randomized multicenter, open-label, Phase II study

Clinical Trials Register.eu (Jul 2009)

The study’s primary objective is to document the activity profile of CCI-779 by the evaluation of OS12 in patients with newly diagnosed glioblastoma (GBM) without methylation of the MGMT gene promoter, treated with CCI-779 before and concomitantly to RT, followed by CCI-779 maintenance therapy.

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Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)

National Cancer Institute (Jun 2009)

The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care in the treatment of newly diagnosed GBM patients. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields) to the region of the malignant tumor, by means of surface, insulated electrodes.

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Phase III Randomized Study of Radiotherapy Alone Versus Radiotherapy With Concurrent and Adjuvant Temozolomide Versus Temozolomide Alone in Patients With Newly Diagnosed 1p/19q Codeleted Anaplastic Glioma

National Cancer Institute (Apr 2009)

The primary objective of this trial is to determine whether there is a survival advantage for patients with newly diagnosed 1p/19q codeleted anaplastic glioma who receive concurrent temozolomide and radiotherapy (RT) followed by adjuvant temozolomide over that observed in patients treated with RT alone (control).

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Open-label, phase II, randomized, comparative, multicentre trial of concurrent Whole Brain Radiation Therapy (WBRT) and capecitabine (Xeloda®) followed by maintenance capecitabine compared with standard WBRT in breast cancer patients with newly diagnosed brain metastasis

Clinical Trials Register.eu (Mar 2009)

To demonstrate the superiority of WBRT with concurrent capecitabine followed by maintenance capecitabine versus WBRT in best objective CNS response (CR + PR) in breast cancer patients with newly diagnoses CNS metastasis.

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Florida Center for Brain Tumor Research (FCBTR)

Clinicaltrials.gov (Dec 2008)

The purpose of this research study is to collect and store brain tumor tissue samples for future research. The samples will become part of the University of Florida Brain Tumor Tissue Bank/Florida Center for Brain Tumor Research. The goal is to find improved treatments and cures for brain tumors.

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High-dose Chemotherapy With Autologous Stem Cell Rescue in Pediatric High-risk Brain Tumors

Clinicaltrials.gov (Nov 2008)

Reduced-dose Craniospinal Radiotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Newly Diagnosed High-risk Brain Tumor; High-dose Chemotherapy and Autologous Stem Cell Rescue in Infants and Young Children with Newly Diagnosed High-risk Brain Tumor To Avoid or Reduce Craniospinal Radiation; High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Recurrent Brain Tumor or Non-germinomatous Germ Cell Tumor with Inadequate Response to Conventional Treatment

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A multicenter phase II clinical trial assessing the efficacy of the combination of lapatinib and capecitabine in patients with non pretreated brain metastasis from HER2 positive breast cancer.

Clinical Trials Register.eu (Oct 2008)

To assess the objective response rate by volumetric analysis of the combination lapatinib and capecitabine on brain metastasis as assessed by MRI, in metastatic HER2 positive breast cancer patients, prior to any brain radiotherapy.

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Adjunctive Donepezil Therapy and Genetic Risk Factors of Cognitive Dysfunction in Brain Tumor Survivors

Clinicaltrials.gov (Jan 2008)

A significant number of brain tumor patients who received radiation or chemotherapy have thinking problems as a result of their treatment. The purpose of this study is to find out if treatment with Aricept (donepezil) may improve some aspects of thinking abilities in patients with brain tumors who received radiation or chemotherapy. This research will also study whether persons having particular genes for a blood-borne substance called apolipoprotein E (APOE) are more likely to have thinking problems after radiation or chemotherapy treatment for their brain tumors. The findings of this study will help us find out whether Aricept can improve thinking abilities after cancer treatment, and whether some of the thinking difficulties may be in part related to having certain genes.

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Risk Factors for Adult-Onset Brain Tumors

Clinicaltrials.gov (Jan 2008)

This is a case-control investigation. Persons affected with a brain tumor are compared to unaffected persons on previous medical history, diet and other factors. Those enrolled in the study will participate in an interview on general background, diet, medical history and lifestyle, and will provide a sample of DNA, clippings of your toenails, and a tap water sample from your home. All procedures are performed in the clinic or through the mail.

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Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme

National Cancer Institute (Jun 2007)

This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared with radiation therapy alone in treating patients with newly diagnosed glioblastoma multiforme.

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Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy

National Cancer Institute (Mar 2007)

The purpose of this study is to investigate the correlation of SV2A expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with their clinical response to levetiracetam.

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A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy

Clinical Trials Register.eu (Mar 2007)

In each of the two study arms (lapatinib plus topotecan or lapatinib plus capecitabine), the primary objective is to determine the CNS objective response rates in subjects with progressive brain metastases from ErbB2-overexpressing breast cancer. A CNS objective response is defined as either a Complete Response (CR) or Partial Response (PR), as assessed by volumetric analysis of brain magnetic resonance imaging (MRI), provided there is no progression of systemic disease outside of the CNS or increasing steroid requirements.

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Gliogene: Brain Tumor Linkage Study

Clinicaltrials.gov (Jan 2007)

The goal of this research study is to investigate the role of genes that may point to a higher risk of developing a glioma. Researchers will use new gene mapping techniques to study how high-risk factors are passed on through a family's genes and increase the risk of developing gliomas. We propose an international multi-center, multidisciplinary study consortium, GLIOGENE, to identify susceptibility genes in high-risk familial brain tumor pedigrees using the most sophisticated genetic analysis methods available.

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Safety Study of Intracerebral Topotecan for Recurrent Brain Tumors

Clinicaltrials.gov (Mar 2006)

This study will evaluate the safety and efficacy of a chemotherapeutic drug (topotecan) as it is given directly into brain tumors by a delivery technique called convection-enhanced delivery. This drug has been used for different types of cancer, but in this study it will be given by an experimental delivery technique designed to maximize the amount of drug delivered to the brain tumor and minimize the side effects in other parts of the body. This study will also evaluate advanced MR imaging techniques. The study will assess quality of life parameters throughout the follow-up period.

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Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer (ADAPT)

Clinicaltrials.gov (Mar 2013)

The trial will evaluate the optimal treatment with nab-paclitaxel in combination with either carboplatin or gemcitabine for patients with triple negative breast cancer.

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NeoPHOEBE: Neoadjuvant Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive Primary Breast Cancer

Clinicaltrials.gov (Mar 2013)

This randomized, parallel cohort, two stage, double-blind, placebo-controlled study will evaluate the oral PI3K inhibitor BKM120 in combination with trastuzumab and paclitaxel in HER2-positive primary breast cancer prior to definitive surgery (neo-adjuvant setting).

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A three-arm, randomized, open label, phase II study of everolimus in combination with exemestane versus everolimus alone versus capecitabine in the treatment of postmenopausal women with estrogen receptor positive, locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on prior letrozole or anastrozole

Clinical Trials Register.eu (Mar 2013)

To estimate the hazard ratio of PFS for everolimus plus exemestane versus everolimus alone in postmenopausal women with ER positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole

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Functional Anatomical Examination of Axillary Sentinel Lymph Node Drainage in the Axillary Subregions in Early Breast Cancer

Clinicaltrials.gov (Mar 2013)

To examine the location of SLN in the axillary subregion (anterior, posterior, central, lateral, apical) in patients with early breast cancer (T <5 cm). To statistically assess correlations between the location, size, histological parameters of primary breast tumor and the subregion of the SLN. To statistically assess SLN positivity and its location within the sbregion. To statistically assess subregional localisation of positive SLN and the number of all positive regional lymph nodes, to predict a limited number of cases with lymph node metastasis, based on the test results of the ACOSOG Z-11 trial, by which ALND could be omitted.

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A randomized, multicenter, open label phase III study to evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy for patients with HER2-positive primary breast cancer who have residual tumor present pathologically in the breast or axillary lymph nodes following preoperative therapy.

Clinical Trials Register.eu (Feb 2013)

To compare the length of time it takes for the primary breast cancer to recur after treatment with preoperative chemotherapy followed by surgery between the 2 treatment arms.

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Randomised, open-label phase II study to compare the safety and efficacy of lapatinib plus trastuzumab or lapatinib plus capecitabine in trastuzumab-resistant HER2-overexpressing metastatic breast cancer

Clinical Trials Register.eu (Feb 2013)

Estimate the clinical benefit of lapatinib plus trastuzumab compared to lapatinib plus capecitabine as measured by investigator-assessed progression-free survival (PFS)

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A Trial of AZD4547 for Breast Cancer That is Oestrogen Receptor Positive and Has Got Worse Despite Having Anastrozole or Letrozole (RADICAL)

Clinicaltrials.gov (Feb 2013)

This study is looking at a new drug called AZD4547 which is being tested for the treatment of oestrogen receptor positive breast cancer. AZD4547 is a drug which specifically "blocks" proteins called fibroblast growth factor receptors (FGFR1) that are involved in the processes that help cancer cells to grow. These proteins may also be responsible for the development of resistance to hormonal therapies used to treat some breast cancers. AZD4547 is not yet approved for use in breast cancer and is therefore being used in this study as a research drug.

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A phase II, randomized study of paclitaxel with gdc-0941 versus paclitaxel with placebo in patients with locally recurrent or metastatic breast cancer

Clinical Trials Register.eu (Feb 2013)

To evaluate the efficacy (as measured by progression-free survival [PFS]) of paclitaxel + GDC-0941 versus paclitaxel + placebo in patients with and without PIK3CA mutations and in all treated patients

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Feasibility Study Of Identification Of Sentinel Node(s) In Breast Cancer (SENTIMAG)

Clinicaltrials.gov (Feb 2013)

The study is based on the identification of sentinel node(s) by SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product). This is a feasibility study

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A Study of the Safety and Effectiveness of Irosustat When Added to an AI in ER+ve Locally Advanced or Metastatic Breast Cancer. (IRIS)

Clinicaltrials.gov (Feb 2013)

70% of breast cancers that occur in postmenopausal women rely on the hormone oestrogen to grow and are likely to respond to hormone treatment. This type of treatment reduces the amount of oestrogen in the body, slowing the growth of cancer or stopping it altogether. One type of hormone treatment, aromatase inhibitors (AIs), works by stopping the body from making oestrogen. Currently, women with locally advanced or metastatic breast cancer that is not being controlled by one class of AI are switched to the other class of AI. The reason for this is that some cancer cells can become resistant to one class but are still sensitive to the other class. However, oestrogen can be made in the body by two pathways and AIs block only one of these pathways. A new drug called Irosustat can reduce the production of oestrogen in the body by blocking the second pathway. This study is investigating whether adding Irosustat to AI treatment i.e. blocking both pathways at the same time, can further reduce the amount of oestrogen in the body and therefore control the breast cancer better. 27 postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer that is not being controlled by their current AI treatment will be recruited in this study from 9 United Kindgom (UK) hospitals. Eligible patients will receive 40mg of Irosustat once daily in addition to the AI on which they progressed. Patients will receive Irosustat for as long as it controls their cancer or until they have side effects that stop them from taking treatment. Patients will be seen monthly for the first 6 months and every 3 months thereafter. Participating patients will also be given the option to take part in the exploratory part of this study by donating tissue and blood samples.

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Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer (ADAPT)

Clinicaltrials.gov (Jan 2013)

Trial for the optimization of risk assessment and therapy success prediction in patients with early breast cancer by the use of biomarkers in advance to therapy decision-making to personalize therapies.

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Efficacy and Safety of Cabazitaxel Versus Weekly Paclitaxel as Neo-adjuvant Treatment in Patients With Triple Negative or Luminal B/HER2 Normal BC (GENEVIEVE)

Clinicaltrials.gov (Jan 2013)

Cabazitaxel is a new taxoid which promotes the tubulin assembly in vitro and stabilizes microtubules against cold-induced depolymerization as efficiently as docetaxel and was selected for development based on a better antiproliferative activity on resistant cell lines than docetaxel. It has shown superior survival against mitoxantrone (MTX) plus prednisone in docetaxel pre-treated hormone refractory metastatic prostate cancer patients leading to registration of the compound. It showed a favorable toxicity profile with an interestingly low rate of alopecia. In the Genevieve study it will be compared against weekly paclitaxel which is currently most widely used treatment of breast cancer patients. A head-to-head comparison in the neoadjuvant setting will allow a rapid and precise comparison of efficacy and tolerability of cabacitaxel versus paclitaxel to decide in how far further development of this taxoid in breast cancer is reasonable.

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A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)

Clinicaltrials.gov (Jan 2013)

This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.

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Everolimus Beyond Progress for Patients Who Had Progress Under Everolimus and Exemestane (Evelyn)

Clinicaltrials.gov (Jan 2013)

Everolimus will be given to patients with metastatic breast cancer who already has a progress taking Everolimus but with a change in the endocrine treatment.

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Randomised phase II study evaluating, as first-line chemotherapy, weekly oral vinorelbine as a single-agent versus weekly paclitaxel as a single-agent in estrogen receptor positive, HER2 negative patients with advanced breast cancer.

Clinical Trials Register.eu (Nov 2012)

To evaluate, as a first-line chemotherapy, the disease control rate (DCR) of weekly oral vinorelbine as a single-agent versus weekly paclitaxel as a single-agent in estrogen receptor positive, HER2 negative patients with advanced breast cancer.

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MicroBubble detection and Ultrasound guided Biopsy of axillary Lymph nodes in patients with Early breast cancer.

Clinical Trials Register.eu (Sep 2012)

To see if using an ultrasound visible "dye" (microbubble) to detect the sentinel lymph node draining the breast and to comprehensively biopsy the node once identified can significantly improve the pre-operative diagnosis of axillary (armpit) lymph gland (node) cancer deposits in patients with breast cancer.

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Phase II study of cabazitaxel as 2nd-line treatment in patients with HER-2 negative metastatic breast cancer previously treated with taxanes

Clinical Trials Register.eu (Aug 2012)

The primary objective is to assess the clinical activity of cabazitaxel regarding the objective response rate (ORR).

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Neurotoxicity characterization phase II randomized study of nab-paclitaxel versus conventional paclitaxel as first-line therapy of metastatic HER2-negative breast cancer.

Clinical Trials Register.eu (Jul 2012)

To characterize neurotoxicity according to Total Neuropathy Score

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Phase II study of irinotecan weekly in combination with trastuzumab in patients with locally advanced or metastatic HER2-positive breast cancer and increased cancer cell copy number of TOP1

Clinical Trials Register.eu (Jun 2012)

Response rate according to RECIST 1.1

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A phase III randomized, double-blind placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer which progressed on or after aromatase inhibitor treatment.

Clinical Trials Register.eu (Jun 2012)

To assess the treatment effect of BKM120 once daily plus fulvestrant versus BKM120 matching placebo once daily plus fulvestrant on progression-free survival (PFS)

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A phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of bevacizumab, and associated biomarkers, in combination with paclitaxel compared with paclitaxel plus placebo as first-line treatment of patients with HER2-negative metastatic breast cancer

Clinical Trials Register.eu (May 2012)

To evaluate the efficacy of bevacizumab + paclitaxel compared with placebo + paclitaxel as first-line treatment in patients with HER2-negative metastatic breast cancer as measured by: - PFS based on investigator tumor assessment in the intent-to treat (ITT) patient population - PFS based on investigator tumor assessment in ITT patients with high plasma VEGF-A levels

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A randomized, double-blind, placebo controlled, phase II study of BKM120 plus paclitaxel in patients with HER2 negative inoperable locally advanced or metastatic breast cancer, with or without PI3K pathway activation.

Clinical Trials Register.eu (May 2012)

To assess the treatment effect of BKM120 once daily plus weekly paclitaxel versus BKM120 matching placebo once daily plus weekly paclitaxel on progression-free survival (PFS)

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High-dose alkylating chemotherapy in oligo-metastatic breast cancer harboring homologous recombination deficiency

Clinical Trials Register.eu (May 2012)

This study will investigates the effect of high dose alkylating chemotherapy compared to standard dose chemotherapy as part of a multimodality approach in patients with oligometastatic HRD positive or BRCA1/2 related breast cancer.

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A Phase III randomized trial of metformin versus placebo on recurrence and survival in early stage breast cancer.

Clinical Trials Register.eu (May 2012)

The MA.32 study will investigate whether adding 5 years of metformin treatment to standard of care treatment for breast cancer, decreases the likelihood of breast cancer returning.

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EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

National Cancer Institute (Apr 2012)

This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies

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Adjuvant phase III trial to compare intense dose-dense adjuvant treatment with EnPC to dose dense, tailored therapy with dtEC-dtD for patients with high-risk early breast cancer

Clinical Trials Register.eu (Apr 2012)

Comparison of disease-free survival

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A randomized phase III trial comparing nanoparticle-based paclitaxel with solvent-based paclitaxel as part of neoadjuvant chemotherapy for patients with early breast cancer (GeparSepto)

Clinical Trials Register.eu (Apr 2012)

To compare the pathological complete response (pCR=ypT0 ypN0) rates of neoadjuvant treatment of nab-paclitaxel with solvent-based paclitaxel as part of neoadjuvant treatment of operable or locally advanced primary breast cancer.

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The BEACON Study (BrEAst Cancer Outcomes with NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 versus Treatment of Physician’s Choice (TPC) in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracycline, a Taxane, and Capecitabine

Clinical Trials Register.eu (Mar 2012)

To compare the Overall Survival (OS) of patients who receive NKTR-102 given once every 21 days to patients who receive TPC selected from the following list of seven single-agent intravenous therapies: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel or nab-paclitaxel.

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A Phase IIIB, Multi-Center, Open Label Study For Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Treated With Everolimus (RAD001) in Combination With Exemestane

Clinical Trials Register.eu (Mar 2012)

To assess the Overall Response Rate (ORR) in postmenopausal women with hormone receptor positive breast cancer progressing following prior therapy with NSAIs treated with the combination of Everolimus and Exemestane.

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A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less.

Clinical Trials Register.eu (Feb 2012)

To determine the effect of chemotherapy in breast cancer patients with lymph node that do not have the Recurrence Score (RS) high by Oncotype DX® test.

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Effect of oral administration of red clover on menopausal symptoms of the syndrome induced by adjuvant hormonal treatment in women diagnosed with breast cancer

Clinical Trials Register.eu (Feb 2012)

Decrease of menapausal symptoms in women treated with tamoxifen for breast cancer after surgery

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A Multicenter Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer.

Clinical Trials Register.eu (Feb 2012)

To assess the antitumor activity of PM01183 in terms of overall response rate (ORR) according to RECIST vs 1.1 in each cohort of metastatic breast cancer (MBC) patients.

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A phase II trial of BKM120 (a PI3K inhibitor) in patients with triple negative metastatic breast cancer

Clinical Trials Register.eu (Jan 2012)

To determine clinical activity of BKM120 in patients with metastatic triple negative breast cancer that have developed disease progression after standard chemotherapy in the adjuvant or metastatic setting.

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Assessment of multidrug resistance in breast cancer with [11c]Tariquidar PET

Clinical Trials Register.eu (Jan 2012)

To correlate PET imaging outcome parameters (e.g. volume of distribution (VT) of [11C]tariquidar in tumor tissue) at staging with Pgp expression levels measured by IHC at baseline (diagnostic biopsy)

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A prospective, randomised multi-centre phase II study evaluating the adjuvant, neoadjuvant or palliative treatment with tamoxifen +/- GnRH analogue versus aromatase inhibitor + GnRH analogue in male breast cancer patients.

Clinical Trials Register.eu (Jan 2012)

To determine the estradiol suppression between the three treatment arms after three months.

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A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

Clinical Trials Register.eu (Jan 2012)

To assess the progression-free survival of oral veliparib in combination with temozolomide or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and metastatic breast cancer.

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National Screening in Denmark With MR Versus Mammography and Ultrasound of Women With BRCA1 or BRCA2 Mutations

National Cancer Institute (Dec 2011)

The purpose of the study is to determine whether MR of the breast is a better screening tool than mammography combined with ultrasound of the breast in women with BRCA1 or BRCA2 gene mutations.

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STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing Pilot)

National Cancer Institute (Dec 2011)

This is a randomized study comparing the use of Anastrozole before and continuing during radiotherapy for breast cancer compared to the use of anastrozole after irradiation.

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A randomised phase II trial of [18F]fluorothymidine and the standard tracer [18F]Fluorodeoxyglucose in the assessment of systemic therapy response in triple negative breast cancer and their utility compared to conventional MRI imaging response, early ADC change and biopsy derived biomarkers

Clinical Trials Register.eu (Dec 2011)

Part A: To confirm repeatability of Positron Emission Tomography (PET) scan SUV measurement before chemotherapy in triple negative breast cancer using [18F]FLT and [18F]FDG tracers Parts A and B: To evaluate PET imaging using each of the two randomly allocated PET tracers ([18F]FLT and [18F]FDG) as a method for evaluating response to systemic therapy in primary triple negative breast cancer at an earlier timepoint than is possible with standard imaging using MRI scans

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Randomised phase II window study of short-term preoperative treatment with the PI3K inhibitor GDC-0941 plus Anastrozole versus Anastrozole alone in patients with ER-positive primary breast cancer

Clinical Trials Register.eu (Nov 2011)

In women with ER-positive breast cancer about to undergo surgery, does two week's pretreatment with a new drug (the PI3K inhibitor GDC-0941, given in combination with the estrogen-blocker anastrozole) increase the benefits of anastrozole in slowing down tumour cell growth, as measured by laboratory measurements on tumour cells?

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A randomized, double-blind, parallel-group, multi-center Phase III study comparing the efficacy and safety of EP2006 and Neupogen® in breast cancer patients treated with myelosuppressive chemotherapy

Clinical Trials Register.eu (Nov 2011)

To assess the efficacy of EP2006 compared to Neupogen® (US-licensed) with respect to the mean duration of severe neutropenia (DSN), defined as the number of consecutive days with Grade 4 neutropenia (absolute neutrophil count [ANC] less than 0.5 x 10 9/L), during Cycle 1 of the neoadjuvant or adjuvant TAC regimen (Taxotere® [docetaxel 75 mg/m2] in combination with Adriamycin® [doxorubicin 50 mg/m2] and Cytoxan® [cyclophosphamide 500 mg/m2]) in breast cancer patients.

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Genomic Testing for Primary Breast Cancer

Clinicaltrials.gov (Apr 2011)

The goal of this research study is to find out if researchers can use genetic testing on tumor samples to predict if tumors will respond to breast cancer treatments. The tumor sample will be tested to learn if certain genes are activated (turned on) in the tumor. Researchers hope that the activation of these genes may predict if the tumor will be sensitive or resistant to routine breast cancer treatments, such as chemotherapy or hormonal therapy.

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Breast Cancer Prevention Education

Clinicaltrials.gov (Feb 2011)

We will develop and evaluate a community-based approach for disseminating comparative effective reviews (CERs) about breast cancer prevention to African American women. The specific aims of our research, as shown below, will target this population because of persistent disparities in breast cancer morbidity and mortality among this population. Our primary aims are: To evaluate uptake of a community-based strategy for disseminating CERs about breast cancer prevention to African American women based on sociodemographic characteristics, beliefs about medical research, and medical history. We predict that participation in a community forum will be higher among women with greater socioeconomic resources, those who have a family history of breast cancer, and women who have more positive beliefs about research. Secondly to evaluate the impact of evidential versus non-evidential content about breast cancer prevention on psychological and behavioral outcomes that include: knowledge of breast cancer risk factors and prevention strategies, communication with individuals in their social and medical network, and distrust of medical research. We predict that women who receive evidential content that is specific for African American women will report greater knowledge about breast cancer risk factors and prevention strategies, will be more likely to discuss breast cancer prevention strategies with individuals in their social and medical network, and will report greater reductions in distrust of medical research compared to those who receive non-evidential content.

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Fulvestrant with or without AZD6244, a mitogen-activated protein kinase kinase (MEK) 1/2 inhibitor, in advanced stage breast cancer progressing after aromatase inhibitor: a randomized placebo-controlled double-blind phase II trial.

Clinical Trials Register.eu (Nov 2010)

The primary objective of the trial is to assess the efficacy of the combination AZD6244-fulvestrant in patients with endocrine sensitive breast cancer progressing after aromatase inhibitors.

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Optimizing tamoxifen therapy through the induction of CYP3A4, CYP2C and CYP2D6 mediated metabolism

Clinical Trials Register.eu (Nov 2010)

To determine the influence of cytochrome P450 enzyme induction (including CYP3A4, CYP2C and CYP2D6) by rifampicin on the metabolism and plasma pharmacokinetics of tamoxifen and its metabolites in breast cancer patients.

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MIRNA Profiling of Breast Cancer in Patients Undergoing Neoadjuvant or Adjuvant Treatment for Locally Advanced & Inflammatory Breast Cancer

Clinicaltrials.gov (Oct 2010)

MicroRNAs (MiRNAs) regulate the translation of RNAs and are implicated in cell proliferation and renewal both under physiologically normal as well as in malignant conditions. Dysregulation of specific miRNAs may be associated with either gaining oncogenic or loosing tumor suppressing functions. MiRNA dysregulation has been implicated in breast cancer tumorigenic (stem cell) and non-tumorigenic development. Therefore, miRNA profiling of treatment naïve and treatment-exposed breast tumors and sequential samples of blood/serum will allow for identification of miRNA markers of prognosis and as indicators and potential targets for personalized therapies. In this proposal, specimens from patients treated in the clinical breast cancer program on already existing protocols (IRB 05091 and 05015) will be characterized by Dr. Rossi's laboratory and collaborators, and the information gained will be applied to develop specific therapies.

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An open label, phase II trial of BIBW 2992 (afatinib) in patients with metastatic HER2-overexpressing breast cancer failing HER2-targeted treatment in the neoadjuvant and/or adjuvant treatment setting

Clinical Trials Register.eu (Oct 2010)

To investigate the efficacy and safety of BIBW 2992 (afatinib) alone and in combination with weekly treatment with paclitaxel or vinorelbine (in patients who progress on BIBW 2992 (afatinib) monotherapy only) as a new treatment algorithm in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the neoadjuvant and/or adjuvant setting. The primary endpoint is Objective Response (OR) assessed by RECIST 1.1

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Pre-Surgery Positron Emission Mammography in Patients With Newly Diagnosed Breast Cancer

Clinicaltrials.gov (Oct 2010)

The purpose of the study is to determine the optimal, lowest dose of radioactive tracer required for Positron Emission Mammography (PEM), and the accuracy and reliability of PEM in pre-surgical evaluations for patients with newly diagnosed breast cancer anticipating breast-conserving surgery but identified to have a second unsuspected breast cancer by MRI.

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Etude de phase II randomisée multicentrique évaluant l'efficacité d’estramustine phosphate (Estracyt ®) chez des patientes présentant un cancer du sein métastatique HER2- / RH+ ayant déjà reçu un traitement par inhibiteur d’aromatase

Clinical Trials Register.eu (Sep 2010)

To determine the percentage of progression free survival after a 6-month monotherapy of Estramustine in patients with HER2-/RH+ breast cancer progressing after having already undergone either a first line adjuvant treatment by aromatase inhibitors (AI)

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A Randomised Double-blind Phase IIa Study (with Combination Safety Run-in) to Assess the Safety and Efficacy of AZD4547 in Combination with Exemestane vs. Exemestane Alone in ER + Breast Cancer Patients with EGFR Polysomy or Gene Amplification Who Have Progressed Following Treatment with One Prior Endocrine Therapy (Adjuvant or First-line Metastatic). (GLOW)

Clinical Trials Register.eu (Jul 2010)

The main objectives of this trial are to assess the safety and tolerability and to determine a dose of AZD4547 in combination with a standard dose of exemestane. Also to assess the relative efficacy of AZD4547 in combination with exemestane compared with exemestane alone by comparison of the change in tumour size at 12 weeks.

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Use of Metformin to reduce serum level of Testosterone and improve the metabolic picture in women treated for breast cancer.

Clinical Trials Register.eu (Jun 2010)

Relatively high level of Testosterone, due to insulin resistance, are asociated with higher risk of breast cancer (BC) and even of recurrences of BC. The main objective is to define the smallest dose of Metformin able to reduce augmented serum level of T and to modify other metabolic parameters in menopausal women on treatment for BC (randomised comparison of two doses)

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Breast Cancer Rehabilitation Program in Improving Quality of Life in Breast Cancer Survivors

Clinicaltrials.gov (Apr 2010)

This clinical trial studies a breast cancer rehabilitation program in improving quality of life in breast cancer survivors.

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Brain Metastasis in Breast Cancer Patients

Clinicaltrials.gov (Feb 2010)

The purpose of this epidemiologic study is to establish a population-based cohort of women with advanced stage breast cancer which can be used to quantify the frequency and timing of brain metastases, and other distant metastases, in this patient population.

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Evaluation of the effect of pasireotide LAR administration in the lymphocele prevention after axillary node dissection for breast cancer

Clinical Trials Register.eu (Feb 2010)

The primary objective of this study is to assess the efficacy of a preoperative prolonged release pasireotide injection in the reduction in the incidence of symptomatic, postoperative axillary lymphoceles following mastectomy-axillary node dissection.

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Open-Label study of bevacizumab (Avastin®) and taxane monotherapy for the first-line treatment of patients with advanced triple-negative breast cancer

Clinical Trials Register.eu (Oct 2009)

Tolerability and safety profile of bevacizumab when combined with weekly paclitaxel as first line treatment of metastatic triple negative breast cancer.

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A multi-center, open label Phase II trial of TKI258 in FGFR1 amplified and non-amplified metastatic HER2 negative breast cancer.

Clinical Trials Register.eu (May 2009)

The purpose of this study is to determine the Overall Response Rate (ORR) in 4 groups of patients with (FGFR1+, HR+),(FGFR1+, HR-),(FGFR1-, HR+) or (FGFR1-, HR-) breast tumors treated with TKI258.

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Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer (SN-FNAC)

Clinicaltrials.gov (May 2009)

The primary objective is to evaluate the accuracy of sentinel node biopsy in breast cancer patients presenting with positive nodal disease, proven by ultrasound guided fine needle aspiration, following neoadjuvant chemotherapy. While the secondary objectives are to evaluate the technical success of sentinel node biopsy following neoadjuvant chemotherapy, and evaluate the accuracy of clinical examination and ultrasound examination of the axilla in identifying the presence of residual disease in the axilla following neoadjuvant chemotherapy in biopsy proven node positive breast cancer patients.

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Use of the Contura™ Catheter in Intermediate-Risk, Pathological Stage 0, I, or II (Up to 3.0 cm) Breast Cancer Patients

National Cancer Institute (Apr 2009)

The purpose of this study is to determine if a Contura catheter can avoid a radiation "hot spot" in the skin and improve tissue-balloon conformance in early-stage breast cancer patients undergoing accelerated partial breast irradiation.

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Autologous Vaccination With Lethally Irradiated, Autologous Breast Cancer Cells Engineered to Secrete GM-CSF in Women With Operable Breast Cancer

Clinicaltrials.gov (Apr 2009)

The purpose of this trial is to test the safety of a vaccine made from a patient's own breast cancer cells, and determine if this vaccine will delay or stop the growth of the cancer. The vaccine is made by genetically modifying a patient's own tumor cells to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF) to activate the immune response

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An Observational Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Herceptin During Pregnancy or Within 6 Months Prior to Conception

National Cancer Institute (Jan 2009)

The Herceptin Pregnancy Registry is a U.S.-based, prospective, observational cohort study established to obtain data on pregnancy outcomes in women with breast cancer who were treated with a Herceptin-containing regimen during pregnancy or within 6 months prior to conception.

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A Phase II Study of Neo-Adjuvant Statin Therapy in Postmenopausal Primary Breast Cancer - a Window-of Opportunity Study

Clinical Trials Register.eu (Oct 2008)

The primary objective of the current study is to evaluate statin induced effects on tumour proliferation response.

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Randomized placebo-controlled phase III trial of low-dose tamoxifen women whit IntraEphitelial Neoplasia(IEN)

Clinical Trials Register.eu (Jul 2008)

The primary endpoint of the proposed trial is to assess if tamoxifen at a low dose, 5mg/day, reduces the incidence of invasive breast cancer and ductal carcinoma in situ (DIN 1c, 2, 3) of the breast, in women operated on for lobular intraepithelial neoplasia (LIN1, 2 and 3) or ER-positive ductal intraepithelial neoplasia (DIN1b, DIN 2, DIN3, 1a excluded) of the breast.

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Yunzhi as Dietary Supplement in Breast Cancer (YUNZHI-BC)

National Cancer Institute (Apr 2008)

The purpose of this study is to assess the effects of a dietary supplement, the traditional Asian mushroom Yunzhi, as adjuvant in the treatment of patients with breast cancer.

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A Breast Cancer Information Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer (BCCR)

Clinicaltrials.gov (Apr 2008)

This clinical trial is gathering information about patients with breast cancer and their families.

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A phase II study of metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with bevacizumab and erlotinib (BEXE), plus trastuzumab in HER2/neu positive tumors (BEXET), in advanced breast cancer

Clinical Trials Register.eu (Feb 2008)

Main objective of the trial is to assess the activity of the proposed regimen.

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SHORT-HER: Multicentric randomised phase III trial of adjuvant chemotherapy plus 3 vs 12 months of trastuzumab in breast cancer patients with HER2 positive disease

Clinical Trials Register.eu (Nov 2007)

Primary objective is to evaluate if 3 months (9 weekly administrations) of Herceptin (H) administered according to the Finnish protocol are not inferior to 12 months (18 three-weekly administrations) in a standard chemotherapy protocol in term of disease free survival, in patients with HER2 positive early breast cancer.

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A phase II, randomized, multi-center study, assessing value of adding RAD 001 to Trastuzumab as preoperative therapy of HER-2 positive primary breast cancer amenable to surgery

Clinical Trials Register.eu (Oct 2007)

To evaluate the added efficacy obtained by the association of Trastuzumab with RAD001 as preoperative therapy of primary HER-2 positive breast cancer as shown by increased clinical tumor response rate.

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Evaluation de l'efficacité et de la tolérance du Lanreotide LP 90 mg versus placebo dans la diminution de la lyphorrhée post curage axillaire dans les cancers du sein.

Clinical Trials Register.eu (Aug 2007)

Evaluer l'efficacité du Lanréotide LP dans la diminution de la lymphorrhée entre H0 et H0 + 96h après curage axillaire.

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A randomized, multicentral, phase III study of parallel groups to compare the efficiency and tolerance of Fulvestrant (Faslodex) administered for three years in combination with Anastrozol (Arimidex) for 5 years versus Anastrozol for 5 years as adjuvant hormonotherapy in postmenopausal women with early breast cancer and positive hormonal receptors.

Clinical Trials Register.eu (Aug 2007)

To compare free disease survival of patients treated with Fulvestrant for 3 years and anastrozol for 5 years vesus free disease survival of patients treated with anastrozol for 5 years.

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A randomized phase III study comparing trastuzumab plus docetaxel (HT) followed by 5-FU, epirubicin, and cyclophosphamide (FEC) to the same regimen followed by single-agent trastuzumab as adjuvant treatments for early breast cancer

Clinical Trials Register.eu (Jun 2007)

The aim of this study is to compare to compare trastuzumab plus docetaxel (HT) followed by 5-FU, epirubicin, and cyclophosphamide (FEC) to the same regimen followed by single-agent trastuzumab as adjuvant treatments for early breast cancer

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Prospective, Randomized, Single-Blinded, Multi-Center Phase II Trial of the HER2/neu Peptide GP2 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2+ OR the Modified HER2/neu Peptide AE37 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients to Prevent Recurrence

Clinical Trials Register.eu (Jun 2007)

The main objectives of the trial are to determine if the GP2 + GM-CSF vaccine reduces the recurrence rate in HLA-A2+, HER2/neu+, node-positive or high-risk node-negative breast cancer patients randomized to receive either the vaccine versus the immunoadjuvant, GM-CSF, alone. Also to determine if the AE37 + GM-CSF vaccine reduces the recurrence rate in HLA-A2-, HER2/neu+, node-positive or high-risk node-negative breast cancer patients randomized to receive either the vaccine versus the immunoadjuvant, GM-CSF, alone.

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ANZAC: A Randomised Phase II Feasibility Study Investigating The Biological Effects of the Addition of Zoledronic Acid To Neoadjuvant Comnination Chemotherapy On Invasive Breast Cancer

Clinical Trials Register.eu (May 2007)

The principle objective is to study the short-term biological effects of treatment and whether the addition of zoledronic acid to combination neoadjuvant (pre-operative) chemotherapy causes additive or synergistic efects on tumour growth ininvasive breast cancer; specifically assessing apoptosis (programmed cancer cell death) and proliferation (cancer activity). It is hoped the study will determine whether the addition of zoledronic acid to neoadjuvant chemotherapy causes an increase in apoptosis between the diagnostic core biopsy and an additional core biopsy for research purposes on day 5, compared to neoadjuvant chemotherapy alone.

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Pharmacogenetic study of FcγRIIIa and HER2 genes in relation to treatment of breast cancer

Clinical Trials Register.eu (Apr 2007)

Primary objectives are: to determine the influence and frequency of polymorphisms in the FcγRIIIa, HER2 and other related genes on response to trastuzumab with respect to time-to-progression (TTP) and outcome (in patients with advanced/ metastatic breast cancer). To determine the frequency of polymorphisms in the HER2 gene and their association with HER2 expression in tumour samples in both the adjuvant and metastatic setting.

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Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women

Clinicaltrials.gov (Mar 2007)

This natural history study is looking at changes in breast density and gathering health information over time to assess breast cancer risk in women with breast cancer and in healthy women.

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A Study to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Blood of Stage IV Breast Cancer Patients

Clinicaltrials.gov (Jul 2006)

This study is designed to determine whether molecular detection of breast cancer cells in the peripheral blood of Stage IV breast cancer patients is a clinically relevant predictor of progression-free and overall survival. Stage IV breast cancer patients who have measurable breast cancer metastases and are initiating a regimen of systemic therapy are eligible for enrollment. Multi-marker real-time RT-PCR analysis will be performed on peripheral blood specimens from 92 breast cancer patients and 120 healthy volunteers. Peripheral blood specimens from breast cancer patients will be obtained at the time of study entry (prior to initiation of systemic therapy) and at serial time points during follow-up. Subjects will be followed longitudinally until death, although the study has been powered so that the primary objective can be addressed after 12 months of follow-up. Healthy volunteers will be asked to provide a blood sample at time of enrollment but will not be followed.

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EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

National Cancer Institute (Jun 2006)

This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies.

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Vaccination With Autologous Breast Cancer Cells Engineered to Secrete Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Metastatic Breast Cancer Patients

Clinicaltrials.gov (Apr 2006)

The purpose of this trial is to test the safety of a vaccine made from a patient's own breast cancer cells, and determine if this vaccine will delay or stop the growth of the cancer. The vaccine is made by genetically modifying a patient's own tumor cells to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF) to activate the immune response.

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TMMR Register Study (TMMR-RS)

Clinicaltrials.gov (Mar 2013)

TMMR/tLNE was shown to result in very low locoregional recurrence rates and low morbidity in surgical treatment of cervical cancer stage IB-IIA without any adjuvant radiotherapy even in high risk situations. More and more this therapeutic strategy is implemented in clinical routine in specialized cancer centres, thus, treatment of cervical cancer could be performed for these stages in a systematically defined and reproducible radicality; adjuvant radiotherapy could be spared for recurrent disease, thus lowering morbidity and resource assignment in primary treatment dramatically. Due to the nerve-sparing character of the procedure bladder, bowel and sexual dysfunction would also be minimized and markedly benefit the patient. This study is designed to follow up the results of this therapeutic concept adapted to clinical routine in a multiinstitutional register study accompanied by detailed assessment of pathological work-up, quality of life and bladder and sexual function following surgery.

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Intensity-modulated Radiotherapy for Locally Advanced Cervical Cancer (DEPICT)

Clinicaltrials.gov (Feb 2013)

This will be the first study to assess the clinical feasibility of dose escalation with simultaneous integrated boost intensity-modulated radiotherapy for patients with locally advanced cervical cancer. Following screening to confirm eligibility patients will commence a six week treatment period. After this, patients will be followed up by visits to clinic every 3 months for a period of 24 months (2 years). End of study is defined as 24 months after treatment. Patients will be followed up for a minimum of 5 years (as per local policy) after treatment.

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Predicting Outcome in Cervix Carcinoma: a Prospective Study (POCER)

Clinicaltrials.gov (Feb 2013)

The main aim is to validate and improve the predictive model for survival and toxicity in patients with cervical cancer through multicentric prospective data collection. The data contain information on patient, tumor and treatment characteristics. For this study, additional health related QOL scores will be assessed using the EORTC Quality of Life Questionair-CX24 and C30. The long term aim, beyond this specific study, is to build a Decision Support System based on the predictive model validated in this study.

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The Value of Preoperative Sentinel Lymph Node Mapping by Pelvic MR Lymphangiography and SPECT-CT in Cervical Cancer

Clinicaltrials.gov (Jan 2013)

To study the concordance of sentinel node (SN) localization between preoperative Magnetic Resonance Lymphangiography and SPECT-CT SN mapping and the intra-operative SN procedure for low stage cervical cancer.

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Clinica trial PHASE I-II of LEDC (Liposomal Encapsulated Doxorubicin Cytrate, Myocet®) + CARBOPLATIN IN EPITHELIAL ginecological CANCER

Clinical Trials Register.eu (Oct 2012)

Phase I (Dose escalation) To determine the maximum-tolerated dose (MTD) and recommended phase II dose of the combination of Carboplatin + Myocet every three weeks Phase II (Expansion) To evaluate the activity (objective responses) of the combination of Carboplatin+Myocet every 3weeks in patients with PS and PPS relapse.

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Sparing of Organs at Risk in High Dose Rate Brachytherapy

Clinicaltrials.gov (Sep 2012)

Cervix carcinoma is a common malignancy. Radiation therapy still remains a major treatment for patients with carcinoma cervix. Conventional treatment with radiation therapy includes a combination of external beam radiation therapy and intracavitary treatment. Low dose rate intracavitary brachytherapy treatment is already well studied. But high dose rate brachytherapy is a relatively new alternative. In brachytherapy, major developments have been made in the integration of 3D imaging and computerized 3D treatment planning. Medical imaging improvements allowed for better definition of tumoral volumes and organs at risk. The GYN GEC-ESTRO published recommendations on the 3D imaging for better characterization of these volumes. Improvements in CT-SCan and lately in RMN had lead to a better definition of volums of interest (tumor and his extensions and organs at risk : bladder, rectum, sigmoidis, small bowels). RMN is the imaging standard in the evaluation of tumoral extension in cervix cancer. However its use is not easy in many brachytherapy departments. This study will evaluate the feasability and sparing of organs at risk for high dose rate brachytherapy if volume delineation is done at each of the two sessions performed with 3D RMN.

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Diagnostic Performance of 18F-FDG-PET and Diffusion-weighted MRI in the Assessment of Stage IB to IIB2 Cervical Squamous-cell Carcinoma Response to Concomitant Radiochemotherapy and Brachytherapy (ERRICC)

Clinicaltrials.gov (Aug 2012)

The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET in the assessment of cervical cancer response to radiochemotherapy and brachytherapy. Secondary objectives focus on 18F-FDG-PET specificity and likehood ratios as well as diffusion-weighted MRI diagnostic performances.

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Study of a Predictor for Cervix Cancer (ANOXICOL)

Clinicaltrials.gov (Jul 2012)

Non operated cervix cancer (diameter > 4 cm) and stade Ib2-IIb are usually treated by radio-chemotherapy. Non control local rate is inexplicably close to 30%. However, important volume of those tumors and their hypoxia degree induce phenomenon of pathologic angiogenesis, explaining these therapeutic failures. Persistence of tumor hypoxia could be a predictive factor of local control

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A Collagen-Fibrin Patch (Tachosil®) for the Prevention of Lymphoceles after Pelvic Lymphadenectomy in Women with Gynecologic Malignancies: a Randomized Clinical Trial

Clinical Trials Register.eu (May 2012)

We intend to assesswhether or not the intraoperative application of two collagen-fibrin patches (Tachosil®) to the obturator fossa and the femoral canal will reduce the number of sonographically detected pelvic lymphoceles by at least 50% (primary study end point) in women with endometrial or cervical cancer undergoing perlvic lymphadenectomy.

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Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer

National Cancer Institute (Mar 2012)

The purpose of this study is to find out whether patients with cervical cancer treated with IMRT have less side effects with equal cancer control compared to standard radiation techniques. With standard radiation techniques, normal pelvic organs near the tumor receive radiation dose, which leads to side effects. IMRT is a new radiation technique that can reduce radiation dose to these organs and may reduce side effects.

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Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls

National Cancer Institute (Mar 2012)

This is a phase IV study to evaluate the body's immune response of participants to the Cervarix and Gardasil vaccines against the Human Papilloma Virus (HPV) types associated with increased risk of cervical cancer.

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Chemotherapy Followed By Surgery Vs Radiotherapy Plus Chemotherapy in Patients With Stage IB or II Cervical Cancer

National Cancer Institute (Mar 2012)

Randomized phase III trial to compare the effectiveness of chemotherapy followed by radical hysterectomy with that of chemotherapy plus radiation therapy in treating patients who have stage IB or stage II cervical cancer.

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Laparoscopic Approach to Cervical Cancer

National Cancer Institute (Dec 2011)

The goal of this clinical research study is to compare the long-term outcomes of different surgical methods for the treatment of cervical cancer. The long-term outcome of a total abdominal radical hysterectomy (TARH) will be compared against laparoscopy. In this study, the laparoscopy will be done with or without robotic technology.

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Neoadjuvant Chemotherapy Followed by Surgery Versus Concurrent Chemoradiation in Carcinoma of the Cervix

National Cancer Institute (Dec 2011)

Carcinoma cervix is a common malignancy in women in developing countries including India. The standard treatment of locally advanced cervical cancer (Stages IB2 to IIIB)is concomitant chemoradiation (CT RT) using platinum based chemotherapy. Some studies, including a meta-analysis conducted by the Cochrane group, have indicated that few courses of neoadjuvant chemotherapy (NACT) followed by surgery may be superior to radical radiation alone for these patients. However NACT-Surgery approach has never been compared to the current standard of concomitant CT RT. The present study is undertaken to compare, in a randomized trial, NACT(3 courses of paclitaxel-carboplatin) followed by surgery to concomitant CT RT in stages IB2 to IIB squamous cell carcinoma of the uterine cervix.

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Concomitant Chemoradiation in Advanced Stage Carcinoma Cervix

National Cancer Institute (Dec 2011)

A study to evaluate the efficacy of concomitant chemoradiation as compared to radiotherapy alone. Concomitant chemoradiation is not a new treatment modality for carcinoma cervix. Studies have shown improvement in survivals with chemoradiation, but majority of the patients was in early stages. Since this treatment modality has not been tested adequately in advanced stages in our setting, the present study is being undertaken. The study arm of chemoradiation has the potential to improve the survivals by 10%, but is associated with additional 5% risk of toxicities, which are treatable. In the study arm, apart form the standard radiotherapy treatment, you will receive weekly chemotherapy injections (Cisplatin) during external radiation therapy. The study arm is associated with additional 5% acute hematological and gastrointestinal toxicities, which are treatable with medications, blood transfusions, modifications in the ongoing treatment etc.

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Diagnostic accuracy of MRI, diffusion-weighted MRI, FDG-PET/CT and Fluoro-ethyl-choline PET/CT in the detection of lymph node metastases in surgically staged endometrial and cervical carcinoma

Clinical Trials Register.eu (Dec 2011)

This study will evaluate three new imaging techniques that may be used to identify malignant nodes preoperatively: (1) Diffusion Weighted MRI, (2) FDG-PET/CT and (3) FEC-PET/CT. The principal objective is to compare the diagnostic performance of each test (detection and false-positive rates) with that of the standard method (size criteria) with histology as the reference standard.

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A phase III multicentre trial of weekly induction chemotherapy followed by standard chemoradiation versus standard chemoradiation alone in patients with locally advanced cervical cancer

Clinical Trials Register.eu (Nov 2011)

In women with locally advanced cervical cancer, does the addition of weekly chemotherapy prior to chemoradiation alone improve overall survival compared with chemoradiation alone?

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Distribution of Human Papillomavirus (HPV) Genotypes in Patients With Cervical Cancer From Croatia (HPV-cancer)

Clinicaltrials.gov (Jun 2011)

The aim of this study is to describe the pre-vaccination distribution of HPV genotypes in women with high grade cervical squamous intraepithelial lesion (HSIL) and cervical cancer in Croatia.

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Economic Evaluation of Three Populational Screening Strategies for Cervical Cancer (CRICERVA)

Clinicaltrials.gov (Jun 2011)

The aim of this study was to compare the effectiveness and the costs of three types of population interventions to increase the number of female participants in the screening programmes for cancer of the cervix carried out by Primary Care in four Basic Health Care Areas.

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Psychosocial Support for African-American, Latina-American, or European-American Cervical Cancer Survivors

Clinicaltrials.gov (Mar 2011)

This randomized clinical trial is studying how well psychosocial support works in African-American, Latina-American, or European-American cervical cancer survivors.

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A randomized, double-blind, multi-centre, placebo controlled phase II clinical study to evaluate the efficacy, tolerance and safety of an aqueous gel containing 2% (w/w) of cidofovir, directly applied on the cervix exhibiting high grade intraepithelial lesion(s) (CIN 2 and 3)

Clinical Trials Register.eu (Dec 2010)

To evaluate the efficacy and the safety of an aqueous gel containing 2 % (w/w) of cidofovir, directly applied on the cervix exhibiting high grade intraepithelial lesion(s) (CIN 2 and 3).

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Sentinel Concept in Early Stage Cervical Cancer

Clinicaltrials.gov (Jun 2010)

Aim of present study is to inspect, if the removal alone of sentinel lymph nodes in women with early Cervix Carcinoma lead to, at equal length, overall survival like entire systematic dissection of lymph node and at the same time is accompanied with a considerably reduction of associated intra and post operative complications of lymph node dissection.

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A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects

Clinical Trials Register.eu (Jun 2010)

To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of the HPV-015 study so that no cervical sample could be collected.

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Topical Imiquimod in Treating Patients with Persistent HPV-Infection after Surgical or Radiation Treatment of Cervical Cancer

Clinical Trials Register.eu (Apr 2010)

HPV-clearance 20 weeks after randomization.

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A phase III, double-blind, randomized, controlled study to evaluate the efficacy of GlaxoSmithKline Biologicals’ HPV-16/18 VLP/AS04 vaccine compared to hepatitis A vaccines as control in prevention of persistent HPV-16 or HPV-18 cervical infection and cervical neoplasia, administered intramuscularly according to a 0, 1, 6 month schedule in healthy female subjects aged 15 – 25 years or age.

Clinical Trials Register.eu (Apr 2010)

The primary objectives are to demonstrate efficacy of the candidate vaccine compared with control in the prevention of histopathologically confirmed CIN2+ associated with HPV-16 or HPV-18 cervical infection detected in the preceding cytological specimen (by PCR) post dose 3 (after Month 6 to Month 48) in adolescent and young adult women who are negative for HPV DNA (by PCR) at Months 0 and 6 for the corresponding HPV type.

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CIRCCa (Cediranib In Recurrent Cervical Cancer) A Randomised Double Blind Phase II trial of carboplatin-paclitaxel plus cediranib versus carboplatin-paclitaxel plus placebo in metastatic/recurrent cervical cancer

Clinical Trials Register.eu (Mar 2010)

The aim of the study is to provide preliminary evidence regarding whether the addition of cediranib to a combination of carboplatin and paclitaxel will increase progression free survival by 50% in patients with metastatic recurrent cervical cancer.

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Mapatumumab, Cisplatin and Radiotherapy for Advanced Cervical Cancer

Clinicaltrials.gov (Mar 2010)

In this phase 1b/2 study, the investigators will evaluate the safety, tolerability and efficacy of mapatumumab in combination with cisplatin and radiotherapy in patients with locally advanced cervical cancer.

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A Two Part, Phase I-IIa Study Evaluating MK-1775 in Combination With Topotecan/Cisplatin in Adult Patients With Cervical Cancer

Clinical Trials Register.eu (Feb 2010)

Part 1: (1) To determine the safety and tolerability of MK-1775 in combination with topotecan and cisplatin in patients with advanced, metastatic, and recurrent cervical cancer. (2) To establish a Phase II / Maximum Tolerated Dose for MK 1775 in combination with topotecan + cisplatin. (3) To determine the preliminary efficacy of MK-1775 in combination with topotecan and cisplatin in patients with advanced, metastatic, and recurrent cervical cancer. Part 2: (1) To evaluate the effect of the combination of topotecan/cisplatin + MK-1775 versus topotecan/cisplatin alone on PFS in patients with advanced, metastatic, and recurrent cervical cancer. (2) To determine the safety and tolerability of MK-1775 in combination with topotecan and cisplatin in patients with advanced, metastatic, and recurrent cervical cancer.

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A phase 1b/2 study with the agonistic TRAIL-R1 antibody, mapatumumab, in combination with cisplatin and radiotherapy as a first line therapy in patients with advanced cervical cancer

Clinical Trials Register.eu (Sep 2009)

Phase 1b: To evaluate the safety and tolerability of escalating doses of mapatumumab in combination with cisplatin and radiotherapy in subjects with locally advanced cervical cancer. Phase 2: To evaluate the efficacy of mapatumumab in combination with cisplatin and radiotherapy in subjects with locally advanced cervical cancer.

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Prophylactic Irradiation of the Para-Aortic Lymph Nodes in Locally Advanced Uterine Cervical Cancer

Clinicaltrials.gov (Sep 2009)

This study is an open-label, multi-institutional, randomized phase II study, which is designed to investigate the efficacy of Extended-field irradiation (EFI) on reducing recurrences at the para-aortic lymph node (PAN), and also on improving disease-free survival of locally advanced uterine cervical cancer. Radiotherapy is given as a conformal technique based on the individually taken CT scan and cisplatin is given concomitantly with radiotherapy in both PAN + pelvis arm and pelvis only arm. This study includes a translational research component in that all the primary tumors are stained with CA9, a hypoxia marker, before randomization. According to our study result, patients with more hypoxic tumors are more likely to develop distant metastasis including the recurrences at PAN (1-3). Primary cervical cancer tissues are examined for expression of CA9 just after registration, and before the patients are randomized to each arm (pelvis only vs. EFI). We expect a higher benefit of EFI in patients with CA9-positive tumors.

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Significance of prognostic and predictive factors for the efficacy and safety of neoadjuvant chemotherapy in combination with chemoradiation administered in patients with locally advanced cervical cancer.

Clinical Trials Register.eu (Jun 2009)

The main objective are: 1. To evaluate the efficacy of treatment with neoadjuvant cisplatin+gemcitabine based chemotherapy and with concurrent cisplatin+gemcitabine+radiotherapy in locally advanced cervical cancer (defined as response to treatment and progression free survival); 2. To evaluate treatment safety.

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Ixabepilone to Treat Cervical Cancer

Clinicaltrials.gov (Jun 2009)

Objective is to determine whether ixabepilone is effective for treating cervical cancer.

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An International Study on Magnetic Resonance Imaging (MRI)-Guided Brachytherapy in Locally Advanced Cervical Cancer (EMBRACE)

Clinicaltrials.gov (Jun 2009)

Aims: To introduce MRI based 3D-4D BT in locally advanced cervical cancer in a multicenter setting within the frame of a prospective observational study. To establish a bench-mark for clinical outcome with image based BT in a large patient population with respect to local control, survival, morbidity and QoL. To establish a reference material with regard to image based DVH parameters according to the guidelines from the GEC ESTRO working group. To correlate image based DVH parameters for CTV and for OAR with outcome. To develop prognostic and predictive statistical models for clinical outcome including volumetric, dosimetric, clinical and biological risk factors. To establish radiobiological parameter estimates that will allow a precise risk estimation in individual patients and aid in the development of new treatment protocols.

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A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5x10E7pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infection

Clinical Trials Register.eu (May 2009)

To assess the efficacy, in the IA population, of RO5217790 compared to placebo in achieving histologic resolution at Month 6 (determined by evaluation of tissue derived from surgical excision of the entire lesion area). Full analysis: To assess the efficacy of RO5217790 compared to placebo in achieving histologic resolution at Month 6 (determined by evaluation of tissue derived from surgical excision of the entire lesion area) in patients with CIN2/3 associated with HPV16 single infection i.e. stratum 1

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A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR-102 (PEG-Irinotecan) When Given on a Q14 Day or a Q21 Day Schedule in Patients with Metastatic or Locally Advanced Cervical Cancer

Clinical Trials Register.eu (Apr 2009)

To determine the objective response rate (ORR) with NKTR-102 given on one of two schedules: once every 14 days (q14d) and once every 21 days (q21d)

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A Randomized Phase II Study Of Carboplatin And Paclitaxel +/- Cetuximab, In Advanced And/Or Recurrent Cervical Cancer

Clinical Trials Register.eu (Apr 2009)

To assess the activity of a combination of cetuximab (weekly) with carboplatin + paclitaxel (every three weeks) comparing it to chemotherapy alone in terms of event-free survival (EFS).

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Topical Imiquimod in Treating Patients with Grade 2/3 Cervical Intraepithelial Neoplasia

Clinical Trials Register.eu (Jan 2009)

To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3.

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Radical Trachelectomy for Cervical Cancer

Clinicaltrials.gov (Dec 2008)

The primary objective of this study is to longitudinally assess quality of life, sexual functioning, symptoms, and satisfaction with healthcare decisions in women who have undergone abdominal radical trachelectomy for cervical cancer. The secondary objectives are: To determine long-term fecundity and pregnancy outcomes in women who have undergone abdominal radical trachelectomy for cervical cancer, to determine short- and long-term operative outcomes in women who have undergone abdominal radical trachelectomy for cervical cancer, and to determine disease-free and overall survival in women who have undergone abdominal radical trachelectomy for cervical cancer.

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Development & Validation of Utilities for Health States Relevant to Cervical Cancer Patients

Clinicaltrials.gov (Nov 2008)

Purposes of this study: 1) To define comprehensive set of descriptive health states related to treatment of cervical cancer (e.g. radical hysterectomy, whole pelvic radiation, brachytherapy, chemoradiation) 2) To define set of descriptive health states related to adverse events associated w treatment of cervical cancer (i.e. bladder dysfunction, pain, enteritis, fistula formation) & 3) To derive, using a validated method, a set of QoL related utility scores corresponding to these health states.

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Sexual Functioning in Cervical Cancer Survivors

Clinicaltrials.gov (Aug 2007)

Primary Objectives: 1. To assess the entire range of sexual functioning (desire, arousal, orgasmic capacity, dyspareunia, and sexual satisfaction) over the course of treatment and early follow-up in patients with local and locally advanced cervical cancer; 2. To assess general cancer-related QOL over the course of treatment and early follow-up in patients with local and locally advanced cervical cancer; 3. To characterize the relationship between sexual dysfunction and overall cancer-related QOL over time; and 4. To identify factors that may predict better sexual function outcomes in patients treated for cervical cancer.

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DNA Array Analysis of Patients With Cervical Cancer

Clinicaltrials.gov (Aug 2007)

The primary objectives of this study are: To obtain preliminary descriptive data on early changes in tumor DNA array expression following chemo-radiation of cervical cancer. These data will permit the design a future studies to correlate array expression changes with clinical outcome. To quantify the degree of therapy-induced apoptosis following chemo-radiation of cervical cancer in order to design future studies to correlate apoptosis levels with clinical outcome. To store material to later correlate the tumor DNA array expression with specific strains of tumor-related human papilloma virus (HPV) and finally to correlate changes in biomarker expression with clinical outcome and findings of the DNA array analyses.

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A Phase I/II Study of Cisplatin and Radiation in Combination With Sorafenib in Cervical Cancer

Clinicaltrials.gov (Jul 2007)

This will be a multi-institution, single-arm, open-label, phase I/II trial. Eligible patients will have pathologically-proven T1b-3b, N0/1, M0 epithelial carcinoma of the cervix. We hypothesize that sorafenib in combination with chemotherapy and radiotherapy may have anti-tumor activity in patients with cervical cancer. Sorafenib has not previously been combined with conventional RT-CT to treat cervix cancer.

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Simple Versus Radical Hysterectomy for Stage I Cervical Cancer

Clinicaltrials.gov (Jul 2007)

The primary objective of this study is to assess the preferences (values and utilities) of women for complications and recurrences associated with the surgical treatment of cervical cancer. A secondary objective of this study is to compare the preferences of women at high-risk for developing cervix cancer with the preferences of women who have already been diagnosed with cervix cancer.

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HPV Testing for Cervical Cancer Screening Study

Clinicaltrials.gov (Apr 2007)

This is a randomised controlled trial of HPV testing with cytology triage for HPV positive women compared to liquid-based cervical cytology (LBC). Although LBC is not widely used for cervical cancer screening in Canada at present, the Pan-Canadian Cervical Cancer Forum has recommended its use and as it is likely to be the standard of care by the time these data are published, the trial has been designed to account for this. Further, LBC will improve the cost-effectiveness of HPV testing because the LBC medium is suitable for both HPV testing as well as cytology and thereby allows the triage testing to be undertaken from the same sample without having to recall the women.

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Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive Cervical Cancer

Clinicaltrials.gov (Apr 2007)

This clinical trial is studying genes that may predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer.

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Fludeoxyglucose F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer

Clinicaltrials.gov (Dec 2006)

This phase I/II trial is studying how well fludeoxyglucose F 18 PET scan, CT scan, and ferumoxtran-10 MRI scan finds lymph node metastasis before undergoing chemotherapy and radiation therapy in patients with locally advanced cervical cancer or high-risk endometrial cancer.

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A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination with Lapatinib (GW572016) Compared to Pazopanib Montherapy and Lapatinib Monotherapy in Subjects with FIGO Stage IVB or Recurrent or Persistent Cervical Cancer with Zero or One Prior Chemotherapy Regimen for Advanced/Recurrent Disease

Clinical Trials Register.eu (Nov 2006)

To evaluate progression-free survival (PFS) of the combination regimen versus each of the monotherapy arms in subjects with FIGO Stage IVB, or recurrent or persistent cervical cancer who have had zero or one prior chemotherapy regimen for advanced disease

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Congenital Transmission of Lineages I and II of Trypanosoma Cruzi

Clinicaltrials.gov (Feb 2013)

T. cruzi has been divided into two main lineages: T. cruzi I (TcI) and T. cruzi II (TcII, including all non-TcI). TcI is predominant in Mexico and Central America, while TcII (non-TcI) is predominant in most of South America, including Argentina. In recent studies from Argentina, the risk of congenital transmission has been estimated to vary between 2.6 percent and 7.9 percent. By contrast, we know very little about the congenital transmission of TcI. It has been suggested that congenital transmission of T. cruzi is strain related, and there is an urgent need to know if TcI transmits differently than TcII (non-TcI). Our primary hypothesis is that congenital transmission rates are different for TcI versus TcII. Our secondary hypothesis is that the characteristics of T. cruzi infected mothers (e.g., age, parity, transmission in previous pregnancies) and their exposure to vectors are different in regions where TcI is predominant versus regions where TcII (non-TcI) is predominant. To test these hypotheses, we propose to conduct a prospective study to enroll at delivery 13,000 women in Mexico, 7,500 women in Honduras, and 10,000 women in Argentina. We will measure transmitted maternal T. cruzi antibodies in cord blood, and, if the results are positive, we will identify infants who are congenitally infected by performing parasitological examinations on cord blood and at 4-8 weeks, and serological follow-up at 10 months. We will also perform standard PCR, real-time quantitative PCR, and T. cruzi genotyping on maternal blood, standard PCR and T. cruzi genotyping on the cord blood of congenitally infected newborns, and serological examinations on siblings. We will estimate the exposure to vectors in the household. In addition, we will measure prenatal outcomes among infected and uninfected infants with seropositive mothers, and the birth weight of their siblings. The specific aims of this study are: 1) To determine the rate of congenital transmission of TcI compared to TcII (non-TcI); 2) To compare the T. cruzi infected mothers' characteristics and exposure to vectors in regions where TcI is predominant and regions where TcII (non-TcI) is predominant; and 3) To describe the birth outcomes of infected and uninfected infants born to TcI and TcII seropositive women.

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Evolution of serologic biomarkers and diastolic function and segmentary contractility determined by echocardiography after treatment in Chagas diseases

Clinical Trials Register.eu (Aug 2012)

Chagas disease (CD), caused by Trypanosoma cruzi, is endemic to Latin America, and is of emerging importance in non-endemic countries because migration of people infected with T. cruzi. Current methods for diagnosis of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce severe side-effects, and their effectiveness cannot be properly evaluated. Reliable biomarkers for prognosis, early diagnosis and effectiveness of treatment will be investigated.

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Population Pharmacokinetics in Benznidazol-treated adults with Chronic Chagas Disease. Benznidazol Pharmacokinetics and adverse reactions relationship.

Clinical Trials Register.eu (Dec 2011)

To study population pharmacokinetics in Benznidazol-treated adult patients with Chronic Chagas Disease to get information to optimaze drug doses.

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Assessment of Therapeutic Response to Benznidazole in patients with Chronic Chagas Disease by Measuring Plasma Parasite Load and the Specific Immune Response against Trypanosoma cruzi. A Randomized, open label, Pilot Clinical Trial

Clinical Trials Register.eu (Jul 2011)

To compare the evolution of the parasite load at baseline and during therapy with benznidazole and in the following 16 months after therapy, in treated and untreated patients. To compare the evolution of the specific immune response against T. cruzi at baseline and during therapy with benznidazole and in the following 16 months after therapy, in treated and untreated patients.

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The Pharmacokinetics of MK-7145 Following Single Dose Administration in Participants With Moderate Renal Insufficiency (MK-7145-018)

Clinicaltrials.gov (Apr 2013)

The primary purpose of this study is to obtain a preliminary pharmacokinetic profile of MK-7145 2 mg immediate release (IR) following single-dose administration in male participants with moderate renal insufficiency. In addition, the study will evaluate the pharmacodynamic effect of a single dose of MK-7145 2 mg IR on 24-hour net natriuresis in male participants with moderate renal insufficiency.

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Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients (SENPARIC)

Clinicaltrials.gov (Mar 2013)

Use of Paricalcitol in stage Vd Chronic Kidney Disease patients, over the effect of inflammatory and oxidative stress parameters.

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Study of Safety and Tolerability of BPS804 in Patients With Late-stage Chronic Kidney Disease

Clinicaltrials.gov (Mar 2013)

The purpose of the study is to evaluate the safety, tolerability, and PK following a single administration of BPS804 in patients with chronic kidney disease stage 5D (CKD-5D) on hemodialysis.

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RAS Blockade at Bedtime Versus on Awakening for Aldosterone Breakthrough (IRAB2)

Clinicaltrials.gov (Feb 2013)

The objective is to show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough.

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The Impact Of Periodontal Disease Treatment On The General Health Status In Chronic Haemodialyzed Patients (PAROHEM)

Clinicaltrials.gov (Jan 2013)

Several studies revealed a direct relationship between the severity of periodontal inflammation and CRP (NHANES III, Dumitriu HT et al, 1998). In patients without any other source of inflammation but PDD, proper dental treatment of the disease decreased CRP to normal levels (Dumitriu H.T. et al., 1998; D'Aiuto F. et al, 2004; Borawski J. et al., 2007) Moreover, a direct link between high levels of CRP and atherosclerotic complications has been found in studies conducted both in general population (Ridker PM, et al., 1998; Koenig W, et al., 1999) and in HD subjects (Westhuyzen J, et al., 2000; Iseki K., et al., 1999; Zimmermann J, et al. 1998).

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Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)

Clinicaltrials.gov (Jan 2013)

Evodial +hemodialyzer consists of an evolution of the existing CE marked Evodial device, with respect to the hemodialyzer membrane removal characteristics. Different membrane prototypes configurations are proposed (3 versions in total), with the objective to modulate the hemodialyzer removal capacities (convective and adsorptive capacities). Materials(including heparin grafted specifications) as well as the sterilization process are identical to the Evodial hemodialyzer. Based on available preclinical data , a clinical study is requested to document in vivo the different prototypes removal capacities with respect to middle Molecular Weight (MW) reference toxins such as b2 Microglobulin and collect data with regards to protein loss.

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A four-week, Phase IIa, randomized, active-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of switching subjects from a stable dose of recombinant human erythropoietin to GSK1278863 in hemodialysis-dependent subjects with anaemia associated with chronic kidney disease

Clinical Trials Register.eu (Oct 2012)

Estimate the relationship between dose of GSK1278863 and hemoglobin (Hgb) response following switching from a stable dose of rhEPO in subjects undergoing HDD.

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Does oral sodium bicarbonate therapy improve function and quality of life in older patients with chronic kidney disease and low-grade acidosis? A multicentre randomized placebo controlled trial

Clinical Trials Register.eu (Oct 2012)

To determine whether oral bicarbonate therapy improves physical function and health-related quality of life compared to placebo in older people with Chronic Kidney Disease (CKD) and mild acidosis

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An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Darbepoetin alfa in Paediatric Subjects From Birth to Less than 1 Year of Age With Anemia due to Chronic Kidney Disease

Clinical Trials Register.eu (Sep 2012)

To evaluate the safety and tolerability of darbepoetin alfa following single 1.5 microgram/kg subcutaneous (SC) dose administration in paediatric subjects < 1 year of age with anaemia due to chronic kidney disease

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A phase III, randomized, assessor-blinded, active-controlled, multicenter study of the efficacy and safety of APO-EPO as compared to Procrit® when given intravenously to patients with anemia and chronic kidney disease stage 5 on hemodialysis, currently not on epoetin replacement therapy

Clinical Trials Register.eu (Aug 2012)

To assess the therapeutic equivalence of Apotex’s epoetin alfa (APO-EPO) versus US licensed epoetin alfa (Procrit®) for correction of the hemoglobin (Hb) concentration in patients with anemia and chronic kidney disease (CKD) stage 5 maintained on stable hemodialysis.

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Safety, Tolerability and Effectiveness of Glocophage®SR in patients with type-2 Diabetes and Chronic Kidney Disease (eGFR 30 to 45mL/minute/1.73m2)

Clinical Trials Register.eu (Aug 2012)

1% Change in HbA1c at the end of study from baseline in the Glucophage® SR group of the study, compared to placebo.

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Renin-Angiotensin System Quantification in patients treated with Aliskiren or Candesartan (RASQAL)

Clinical Trials Register.eu (Jun 2012)

To demonstrate the quantity of differences in the renin-angiotensin peptide profiles in patients receiving direct renin inhibition or angiotensin receptor blockade.

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Oral sodium bicarbonate supplementation in patients with chronic metabolic acidosis and chronic kidney disease

Clinical Trials Register.eu (Jun 2012)

Metabolic acidosis in chronic kidney disease is thought to be the result of an insufficient production of bicarbonate in the renal tubular system. Thus, the intervention of an oral exogenous bicarbonate supplementation to substitute the lacking endogenous bicarbonate seems to be rational. Patients with chronic kidney disease stage III and IV and chronic metabolic acidosis should be randomized to either receive a high dose of oral sodium bicarbonate with a serum target HCO3- level of 24±1 mmol/L or receive a rescue therapy of sodium bicarbonate with a serum target level of 20±1 mmol/L. After two years decline of renal function, as well as mortality rates and time of initiation of renal replacement therapy should be compared across study groups.

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Spironolactone to Prevent Cardiovascular Events in Early Stage Chronic Kidney Disease (CKD): A Pilot Trial

Clinical Trials Register.eu (May 2012)

Patients with reduced kidney function (kidney disease) have high rates of hardening of the blood vessels, which leads to early heart disease and strokes. Previous research has shown that using low dosage of a 'water tablet', spironolactone in patients with early kidney disease in a hospital outpatient setting improved heart structure and function as well as reduced blood vessel stiffness. STOP-CKD study aims to determine if blood vessel stiffness can be safely reduced with the use of low dose spironolactine in people with early stage kidney disease managed at general practices.

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Study of the Safety and Efficacy of LY2623091 in Chronic Kidney Disease Patients

Clinical Trials Register.eu (Mar 2012)

To investigate the effect of LY2623091 on change from baseline in proteinuria after 3 weeks of daily oral dosing in CKD patients.

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DABIRENAL STUDY A study to investigate the pharmacokinetics and effects of Dabigatran in patients with stable severe chronic kidney disease

Clinical Trials Register.eu (Feb 2012)

To analyze the pharmacokinetics and dynamics of Dabigatran 75 mg twice daily in patients with severe CKD (eGFR 15 - 30 ml/min) until steady state of the drug is established.

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Calcitonin stimulation: pentagastrin vs. calcium gluconate - potency, feasibility and tolerance in chronic kidney disease.

Clinical Trials Register.eu (Jan 2012)

Comparison of the two calcitonin stimulation tests pentagastrin and calcium gluconate regarding potency, feasibility and tolerance.

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Open label, single arm, multicenter study to evaluate the safety and immunogenicity of HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in pre-dialysis and dialysis patients

Clinical Trials Register.eu (Nov 2011)

To demonstrate the lack of immunogenicity of HX575 administered s.c. in the treatment of anemia associated with CKD

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A randomised, placebo controlled trial to study the effect of heme-arginate on heme-oxygenase-1 induction and renal function in recipients of deceased donor renal transplants.

Clinical Trials Register.eu (Nov 2011)

Does treating the recipients of deceased donor kidneys with heme-arginate (HA) increase the amount of HO-1 protein in the recipient’s white blood cells compared to placebo treatment?

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A 12-week clinical double-blind, randomised study of cholecalciferol versus placebo in patients with chronic kidney disease stage 3-4 (CHICK).

Clinical Trials Register.eu (Aug 2011)

To investigate whether there is a difference in the mean change from baseline of the blood levels of parathyroid hormone (PTH) between patients receiving cholecalciferol compared with patients receiving cholecalciferol placebo after 12 weeks’ treatment.

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Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients

Clinicaltrials.gov (May 2011)

The primary objective of the study is to determine the prevalence of aspirin resistance in chronic kidney disease patients. The secondary objectives are to determine possible risk factors contributing to aspirin resistance in this population.

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A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety and Renal Efficacy of LY2382770 in Patients with Diabetic Kidney Disease due to Type 1 or Type 2 Diabetes

Clinical Trials Register.eu (Jan 2011)

Primary objective is to determine if LY2382770, administered monthly for 1 year is more effective than placebo at slowing the progression of diabetic kidney disease in patients treated with angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB)

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Does phosphate binding with sevelamer carbonate improve cardiovascular structure and function in patients with early chronic kidney disease?

Clinical Trials Register.eu (Dec 2010)

Reduction of left ventricular mass by reducing dietary phosphate intake with sevelamer carbonate.

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Effect of N-acetylcysteine on hydrogen sulfide in chronic kidney disease

Clinical Trials Register.eu (Nov 2010)

The main objectives of the trial are to investigate the effect of NAC on plasma H2S levels. Secondly to investigate differences in plasma H2S levels between healthy volunteers, CKD patients, and dialysis patients.

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A Risk Based Approach to Improving Chronic Kidney Disease Management

Clinicaltrials.gov (Sep 2010)

Aim 1: To assess whether quality of care for stage 3 chronic kidney disease can be substantially improved over 18 months by: Point of care electronic alerts to primary care physicians recommending risk-appropriate care, and Quarterly mailings to patients providing self management support materials, including tailored recommendations based on personalized data from an electronic disease registry. Aim 2: To assess the relationship between utilization of the intervention components and primary care physician attitudes towards both chronic kidney disease management and electronic reminder systems.

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Effects of an Exercise Program in Patients With Hypertensive Chronic Kidney Disease

Clinicaltrials.gov (Jun 2010)

This study aims to determine the effect of exercise in patients with CKD not yet on dialysis.

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A Proof of Concept, Phase 2a, Double-blind, Parallel Group, Randomised, Placebo controlled Study to Assess the Effect of Lanthanum Carbonate on intact FGF23 in Normo-phosphataemic Subjects with Stage 3 Chronic Kidney Disease

Clinical Trials Register.eu (Mar 2010)

A Proof of Concept, Phase 2a, Double-blind, Parallel Group, Randomised, Placebo controlled Study to Assess the Effect of Lanthanum Carbonate on intact FGF23 in Normo-phosphataemic Subjects with Stage 3 Chronic Kidney Disease

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Study to Evaluate the Effect of Zemplar on Cardiac Morbidity in Patients With Chronic Kidney Disease (CKD) Stage 5 Over 2 Years

Clinicaltrials.gov (Feb 2010)

Hypercalcemia is a well - known factor for cardiac disease. No data are available in Austria for a cohort with cardiac disease treated with Zemplar (Paricalcitol I.V.)

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Weight Loss Interventions in Obese Patients With Stages 3-4 Chronic Kidney Disease: a Randomised Controlled Trial

Clinicaltrials.gov (Jan 2010)

This randomised trial will allocate patients to either lifestyle modification with diet, exercise and pharmacotherapy, or weight loss surgery to remove two thirds of the stomach using the laparoscopic sleeve gastrectomy procedure. This study aims to evaluate weight loss surgery vs lifestyle modification in patients with chronic kidney disease with estimated kidney function of 20-60% and morbid obesity (BMI 35-45) in terms of kidney function, cardiovascular disease risk factors and all-cause mortality.

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Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children 10-16 With Chronic Kidney Disease (CKD).

Clinicaltrials.gov (Nov 2009)

Safety and efficacy study using Paricalcitol capsules to decrease parathyroid hormone levels in children ages 10-16 with Chronic Kidney Disease.

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Vitamin D in addition to RAAS blockade and dietary sodium for the Treatment of Urinary Excretion of albumin: the ViRTUE-study

Clinical Trials Register.eu (Oct 2009)

Does paricalcitol have an additive antiproteinuric respons to RAAS blockade and low sodium diet?

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Immunogenicity and Safety of HEPLISAV™ Hepatitis B Virus Vaccine in Chronic Kidney Disease (CKD) Patients

Clinicaltrials.gov (Sep 2009)

The purpose of the study is to explore the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV™, in patients 18 to 75 years of age who have progressive loss of kidney function.

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Chronic Kidney Disease Antidepressant Sertraline Trial (CAST)

Clinicaltrials.gov (Jul 2009)

This is a randomized double-blinded placebo-controlled trial to see if treatment with sertraline as compared with placebo tablets will improve depression symptoms in patients with chronic kidney disease who have not yet started dialysis or received a kidney transplant. The investigators will also investigate whether sertraline treatment will improve quality of life and whether it is safe to use in patients with kidney disease. The study subject will be randomly assigned to take either sertraline or a placebo tablet for 12 weeks.

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Myocardial Glucose Uptake (MGU) in Patients With Chronic Kidney Disease

Clinicaltrials.gov (Apr 2009)

This study examines patients with chronic kidney disease-related anemia and measures changes in the metabolism of the heart using FDG/PET scanning, before and 6 months after their health-care provider has initiated anemia management therapy with the FDA-approved drug darbepoetin alfa (Aranesp), which is approved for chronic kidney disease-related anemia.

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Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease

Clinicaltrials.gov (Apr 2009)

The goal of this proposal is to investigate the potential for ACE-inhibitors (ACE-I)(drugs primarily used to treat hypertension or congestive heart failure) to prevent or delay cardiovascular disease (CVD) in older adults with chronic kidney disease (CKD) by examining their impact on aortic stiffness in people with stage 3 CKD in a randomized, controlled study.

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Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease

Clinicaltrials.gov (Dec 2008)

People with chronic kidney disease are known to have immune response abnormalities, including a diminished response to some vaccinations. Those with chronic kidney disease have a disproportionate burden of HPV 6-, 11-, 16- and/or 18-related genital tract disease. Due to immune response abnormalities, the CKD population may or may not respond to the recommended three-dose regimen of Gardasil®, a vaccine intended to protect against HPV 6-, 11-, 16-, and 18-related genital tract disease. The objective of this study is to measure the antibody response to Gardasil® in female patients 9-21 years of age with chronic kidney disease (CKD) (Stage 1-4), end-stage kidney disease (Stage 5 CKD), and status-post kidney transplant. Gardasil® vaccine will be administered according to the FDA-approved schedule. Blood samples to measure antibody levels to vaccine strains of human papillomavirus (HPV) will be obtained at months 0, 7 and 24.

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Effects of the dose of erythropoiesis stimulating agents on cardiac-cerebrovascular outcomes and quality of life in hemodialysis patients. The DOSe of Erythropoietins (DOSE) trial.

Clinical Trials Register.eu (Nov 2008)

To evaluate the benefits and harms of high versus low EPOS doses for major patient-level outcomes (mortality, cardiac and cerebrovascular events, safety),quality of life and costs in a population of prevalent outpatient hemodialysis patients.

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Intensive Dietary Education to Lower Serum Phosphorus in Patients With Chronic Kidney Disease

Clinicaltrials.gov (Apr 2008)

The purpose of this study is to determine the effects of a more intensive, innovative dietary phosphorus educational intervention on reducing serum phosphorus levels, as well as improving dietary adherence, dietary satisfaction and phosphorus knowledge level in patients with chronic kidney disease.

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A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AST-120 for Prevention of Chronic Kidney Disease Progression in Patients with Moderate to Severe Chronic Kidney Disease

Clinical Trials Register.eu (Sep 2007)

To demonstrate AST-120, added to standard-of-care therapy in moderate to severe CKD, reduces the risk of progression of CKD as assessed by the development of a component of a triple composite endpoint (initiation of dialysis, kidney transplant, or doubling of sCr), when compared with placebo; and to demonstrate the general safety and tolerability of long-term AST-120 therapy in CKD patients.

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Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Subjects With Chronic Kidney Disease

Clinicaltrials.gov (Feb 2007)

The primary objectives of this study are the following: 1. To test if the proportion of subjects achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa QW for treatment of anemia in pediatric subjects with chronic kidney disease receiving and not receiving dialysis, and 2. To test if the proportion of subjects achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa Q2W for treatment of anemia in pediatric subjects with chronic kidney disease receiving and not receiving dialysis.

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Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney Disease

Clinicaltrials.gov (Oct 2006)

The aim of the trial is to assess the efficiency of intravenous iron therapy in the management of mild to moderate anemia associated with CHF NYHA III class and concomitant moderate CKD.

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Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (DASAPOST)

Clinicaltrials.gov (Feb 2013)

Trial try to assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600.

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Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients (ENESTFreedom)

Clinicaltrials.gov (Jan 2013)

The main purpose of the study is to investigate whether nilotinib treatment can be safely suspended with no recurrence of CML in selected patients who responded optimally on this treatment

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Multicenter Single-arm Pilot Study Evaluating Efficacy of Nilotinib in CML Patients With Molecular Relapse After Glivec Discontinuation Within the Context of the STIM Trials (STIM and STIM2) (Nilo Post-STIM)

Clinicaltrials.gov (Jan 2013)

The objective of this pilot trial is to assess if Nilotinib can rescue STIM patients in molecular relapse after IM discontinuation and to provide an estimation about duration of CMR after nilotinib discontinuation in 2nd line therapy among patients experiencing 2 years of stable CMR with nilotinib.

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A prospective, randomized, open label two arm Phase III study to evaluate treatment free remission (TFR) rate in patients with Philadelphia-positive CML after two different durations of consolidation treatment with nilotinib 300mg BID.

Clinical Trials Register.eu (Jan 2013)

To assess the optimal duration of consolidation treatment with nilotinib 300 mg BID in order that patients remain in treatment free remission (≥MR4.0) without molecular relapse 12 months after cessation of nilotinib.

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Front-line Treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) With Dasatinib (CML1113)

Clinicaltrials.gov (Jan 2013)

The GIMEMA CML Working Party promotes a multicentric, observational, non company sponsored, prospective study of Chronic Myeloid Leukemia (CML) patients treated frontline with dasatinib. Patients will be followed for 5 years. This study will help the definition of guidelines for the treatment of CML patients in early phases. The primary objective of the study is to describe, in the clinical practice, the rate of events leading to permanent discontinuation after 2 years of treatment with dasatinib as frontline therapy in newly diagnosed CML patients.

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A phase II, single arm, open label study of treatment-free remission after achieving sustained MR4.5 on nilotinib

Clinical Trials Register.eu (Dec 2012)

The purpose of this study is to determine the rate of successful treatment-free remission (TFR) within the first 12 months following cessation of treatment in patients who achieved and maintained a molecular response (MR) 4.5 on nilotinib after a switch from imatinib. TFR phase is often referred to as discontinuation phase in other studies.

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Multicenter, open-label, non-randomized Phase II trial of dasatinib in patients with Chronic Myeloid Leukemia in Chronic Phase (CP-CML) who meet criteria for late suboptimal response after prior imatinib treatment.

Clinical Trials Register.eu (Nov 2012)

To assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600.

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An open label, randomized (2:1) Phase 2b study of Dasatinib vs. Imatinib in patients with Chronic Phase Chronic Myeloid Leukemia who have not achieved an optimal response to 3 months of therapy with 400 mg Imatinib

Clinical Trials Register.eu (Nov 2012)

To compare the rate of major molecular response (MMR) at 12 months after Day 1initiation of first line treatment with imatinib, in patients randomized at month 3 to treatment with dasatinib 100mg QD or imatinib at any dose, after less than optimal response to 1st line imatinib

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An international collaborative study to discontinue Imatinib/Glivec® in pediatric CML patients with sustained complete molecular response (STOPIMAPED)

Clinical Trials Register.eu (Oct 2012)

To estimate the percentage of quantitative RT-PCR negative pediatric CML patients in which Imatinib discontinuation result in sustained complete molecular remission

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A safety and efficacy study of adding low dose pegylated ifn-alpha 2b to standard dose dasatinib in patients with newly diagnosed chronic myeloid leukemia

Clinical Trials Register.eu (Aug 2012)

Observe toxicity of drug combination (see protocol) Observe effect measured as response by molecular assessment of BCR-ABL transcript fraction in so called major molecular remission (i.e 3 long below debut levels)

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A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

Clinical Trials Register.eu (Jul 2012)

To compare the efficacy of ponatinib with imatinib as measured by major molecular response (MMR) rate at 12 months (1 month or cycle = 28 days)

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A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies

Clinical Trials Register.eu (Jul 2012)

To investigate whether it is possible to carry out haploidentical/HLA mismatched donor peripheral blood stem cell transplants using high dose cyclophosphamide safely and effectively

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Treatment optimization of newly diagnosed Ph/BCR-ABL positive patients with chronic myeloid leukemia (CML) in chronic phase with nilotinib vs. nilotinib plus interferon alpha induction and nilotinib or interferon alpha maintenance therapy.

Clinical Trials Register.eu (May 2012)

Co-primary objectives are: 1. To evaluate the rate of MMR at 18 months of nilotinib 300 mg BID monotherapy vs. nilotinib 300 mg BID + pegylated interferon alpha (Peginterferon alpha-2b) 2. To evaluate the rate of continuous MMR after discontinuation of nilotinib vs. interferon alpha.

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Study of Nilotinib as First Line Treatment in Philadelphia Chromosome Positive(Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

National Cancer Institute (May 2012)

This study is designed to investigate the molecular and cytogenetic effects and safety profile of nilotinib in the treatment of early chronic phase of Ph+ CML among different risk groups of patients and to compare patients with high Socal risk score with patients having intermediate and low Socal risk score.

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Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients

National Cancer Institute (Apr 2012)

The purpose of this study is to assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months.

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CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib

National Cancer Institute (Apr 2012)

This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients

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Compliance: Role Emerges for Success in Chronic Myelogenous Leukaemia (CML): Evaluation aND Optimisation

National Cancer Institute (Feb 2012)

This study on patient's compliance in clinical workaday life aims to assess and to improve CML treatment in Germany by means of adherence supporting measures and to increase adherence awareness by physicians and patients.

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Registration of Children With CML and Treatment With Imatinib (CML-paed II)

Clinicaltrials.gov (Jan 2012)

Protocol for Standardized Diagnostic Procedures, Registration, and Treatment Recommendations in Children and Adolescents With Philadelphia Chromosome-positive Chronic Myeloid Leukemia (CML)

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Tasigna in Glivec-resistant or Intolerant Patients in CML

National Cancer Institute (Dec 2011)

The purpose of this study is to evaluate efficacy and safety of nilotinib in patients with Imatinib resistant or intolerant CML-CP or AC. Efficacy evaluation will be made by Complete cytogenetic response rate(CCyR) at 12 months after nilotinib administration.

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Patient Reported Outcomes in Chronic Myeloid Leukemia

Clinicaltrials.gov (Dec 2010)

The main scope of this project is develop to an international validated questionnaire for the purpose of HRQOL assessment; such a tool will then be used to provide important data, from the patients' perspective, to make more informed treatment decisions.

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Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting (SIMPLICITY)

Clinicaltrials.gov (Nov 2010)

The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI) in patients newly diagnosed with CML and their quality of life in a real-world setting.

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Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)

Clinicaltrials.gov (Oct 2010)

The purpose of this study is to evaluate the hematological, cytogenetic and molecular response to continuous-use of Imatinib in children with CML Ph+.

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Determining the Maximum Tolerated Dose of Low Dose Interferon-alfa in Conjunction With Nilotinib in Imatinib Resistant and/or Intolerant Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Patients in Chronic Phase (CML-CP) (NICOLI)

Clinicaltrials.gov (Oct 2010)

This study will assess the maximum tolerated dose of low dose interferon in conjunction with nilotinib in imatinib resistant and/or intolerant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia patients in chronic phase (CML-CP).

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PONATINIB for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL) (PACE)

Clinicaltrials.gov (Sep 2010)

The purpose of this study is to determine the efficacy of ponatinib in patients with chronic myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with Ph positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or intolerant to either dasatinib or nilotinib, or have the T315I mutation.

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Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia Patients

Clinicaltrials.gov (Jul 2010)

The goal of this clinical research study is to learn if Nuvigil (armodafinil) can help to control fatigue in patients with chronic myeloid leukemia (CML). The safety of this drug will also be studied.

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Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response (SENSOR)

Clinicaltrials.gov (May 2010)

To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have a suboptimal molecular response to imatinib at 18 months or later.

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A randomised Phase II trial of Imatinib (IM) versus Hydroxychloroquine (HCQ) and Imatinib (IM) for patients with Chronic Myeloid Leukaemia (CML) in Cytogenetic Response (CyR) with residual disease detectable by quantitative polymerase chain reaction (Q-PCR)

Clinical Trials Register.eu (Mar 2010)

To provide preliminary evidence that HCQ given in combination with imatinib is more effective than imatinib alone in terms of BCR/ABL levels in CML patients who are in major cytogenetic response with residual BCR/ABL+ cells after at least one year of imatinib treatment. To determine the safety and tolerability of HCQ given in combination with imatinib in these patients.

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A non-randomized, open-label study to characterize the pharmacokinetics of Glivec/Gleevec® (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)

Clinical Trials Register.eu (Mar 2010)

To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated physiologically-based pharmacokinetic (PBPK) and population pharmacokinetics (pop PK) approaches.

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Phase II efficacy and safety study of Dasatinib in Patients with Chronic and Accelerated Phase Chronic Myeloid Leukaemia Relapsing after Allogeneic Blood or Bone Marrow Transplantation

Clinical Trials Register.eu (Jun 2009)

To assess the efficacy of Dasatinib therapy in chronic and accelerated phase BCR-ABL (+) CML patients that undergo molecular, cytogenetic or haematological relapse following SCT.

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CML-SCT -IBFM Study Allogeneic stem cell transplantation for children and Adolescents with CML: Conditioning regimen, donor selection, supportive care and diagnostic procedures.

Clinical Trials Register.eu (Feb 2009)

To evaluate whether transplant related mortality following allogeneic stem cell transplantation from unrelated donors for CML can be reduced by using a reduced intensity conditioning regimen. To prospectively evaluate the overall survival, the event free survival and the current leukemia free survival in patients undergoing allogeneic stem cell transplantation for CML using a standardised post-transplant monitoring and early intervention

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Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial

Clinicaltrials.gov (Dec 2008)

Investigators thus plan to conduct a chart review of these patients to study their treatment course before their initial evaluation at MDACC, and between and during visits to MDACC.

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Front-line treatment of Philadelphia positive (Ph pos), BCR-ABL positive, chronic myeloid leukemia (CML) with two tyrosine kinase inhibitors (TKI) (Nilotinib and Imatinib). A phase II exploratory multicentric study.

Clinical Trials Register.eu (Jul 2008)

To assess the complete cytogenetic response rate at 12 months

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A phase II multi-center, open-label, study of Nilotinib at a dose of 300mg twice daily in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)

Clinical Trials Register.eu (Jul 2008)

To establish the Complete Cytogenetic Response Rate at 6 months.

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A Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

Clinical Trials Register.eu (Jan 2008)

Compare the rate of complete cytogenetic response (CCyR) at one year in chronic phase subjects receiving bosutinib alone versus chronic phase subjects receiving imatinib alone.

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A Combination of Imatinib Mesylate and Pegylated Interferon α2a in Chronic-Phase Chronic Myeloid Leukemia (UMCC 2006-128)

Clinicaltrials.gov (Dec 2007)

A Phase II Pilot Study Targeting Both the Primitive and Differentiated CML Progenitor Populations: A Combination of Imatinib Mesylate & Pegylated Interferon α2a in Chronic-Phase Chronic Myeloid Leukemia.

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A Phase I/II open label study to assess efficacy and safety of IPH1101 associated with low dose of interleukin 2, as add-on therapy to imatinib in CML patients with residual molecular disease

Clinical Trials Register.eu (Aug 2007)

The primary objective is to assess the efficacy of IPH1101 associated with low dose of IL-2 as add-on therapy to imatinib in CML patients with residual molecular disease after at least 2 years of imatinib monotherapy.

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A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (CGX-635) in the Treatment of Patients with Chronic Myeloid Leukemia (CML) who have failed or are intolerant to tyrosine kinase inhibitor therapy

Clinical Trials Register.eu (May 2007)

To evaluate the safety and efficacy of subcutaneous administration of homoharringtonine (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have failed or are intolerant to tyrosine kinase inhibitor therapy.

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The protein tyrosine kinase inhibitor nilotinib as first-line treatment of Ph+ chronic myeloid leucemia (CML) in early chronic phase: a Phase II exploratory, multicenter study

Clinical Trials Register.eu (May 2007)

To investigate the cytogenetic and molecular effects of the protein tyrosine kinase (PTK) inhibitor nilotinib in the treatment of early chronic phase Ph+ CML.

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A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) (ENESTnd)

Clinicaltrials.gov (May 2007)

In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

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Phase II Multicenter Study Of P210-B3A2 Derived Peptide Vaccine In Chronic Myeloid Leukemia Patients In Complete Cytogenetic Response With Persistent Molecular Residual Disease During Imatinib Treatment

Clinical Trials Register.eu (Apr 2007)

The primary objective of the trial is to evaluate the activity of p210-derived peptides vaccinations in terms of BCR-ABL/ ABL ratio reduction at 6 months from the starting of the vaccination program.

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An extension to a phase II open label study to determine the safety and anti-leukemic effects of STI571 in patients with Philadelphia chromosome positive chronic myeloid leukemia in myeloid blast crisis

Clinical Trials Register.eu (Mar 2007)

The objective of this study is to determine the safety and anti-leukemic effects of STI571 in patients with Philadelphia chromosome positive chronic myeloid leukemia in myeloid blast crisis.

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A Phase II Study Of Velcade Bortezomib - PS341 In The Treatment Of Patients Over 18 Years With Ph Leukemia

Clinical Trials Register.eu (Feb 2007)

The objective of this study is to assess the efficacy and safety of Velcade Bortezomib - PS341 tn the treatment of patients over 18 Years with Ph leukemia.

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A phase II, multicentre study of oral LBH589 in patients with accelerated phase or blast phase (blast crisis) chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors

Clinical Trials Register.eu (Jan 2007)

To assess the hematologic response (complete hematologic response (CHR) / no evidence of leukemia (NEL) / return to chronic phase (RTC)) rate

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A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (CGX-635) in the Treatment of Patients with Chronic Myeloid Leukemia (CML) with the T315I BCR-ABL Gene Mutation

Clinical Trials Register.eu (Sep 2006)

To evaluate the safety and efficacy of subcutaneous administration of homoharringtonine (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have the T315I BCR-ABL gene mutation.

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Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation

Clinicaltrials.gov (Sep 2006)

To evaluate the safety and efficacy of subcutaneous administration of omacetaxine mepesuccinate (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have failed prior imatinib therapy and have the T315I kinase domain gene mutation.

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A randomized two-by-two, multi-center, open-label phase 3 study of BMS-354825

Clinicalstudyresults.org (Jul 2005)

The primary objective of this study was to compare the major cytogenetic response

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Physiotherapy in Exacerbation Chronic Obstructive Pulmonary Disease

Clinicaltrials.gov (Mar 2013)

Chronic Obstructive Pulmonary Disease (COPD) is a chronic condition. Its evolution can be aggravated in some periods by an increase of the symptoms (above all the cough, the dyspnoea and the quantity of sputum purulence). This is known as exacerbation and it is the most frequent cause of hospital stay, urgences services and death in COPD. A physiotherapy program is carrying out in patients attending to the Hospital because of an exacerbation. The hypothesis of this study is that a physiotherapy program added to a medical treatment increase the ventilatory function, the physiques variables, decrease depression and anxiety and improve the quality of life. Additionally, it is going to be assessed the effect of physiotherapy in time using phone calls and visits to the patient's home.

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A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol and Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Clinicaltrials.gov (Mar 2013)

This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with COPD. Subjects who meet the eligibility criteria at Screening will complete a 7 to 14 day Run-in period. At the end of the run-in period, approximately 710 eligible subjects will be equally randomized (to complete at least 568 evaluable subjects) to one of the 2 treatment groups for 12 weeks: 1. UMEC/VI 62.5/25 micrograms (mcg) administered as one inhalation once-daily in the morning via the Novel dry powder inhaler (NDPI) + placebo administered as one inhalation each morning and evening via single multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC 250/50 mcg administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once-daily in the morning via NDPI. A safety Follow-up assessment will be conducted approximately 7 days after the end of the study treatment (Early Withdrawal, if applicable). The total duration of subject participation will be approximately 15 weeks.

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A randomized, double blind, placebo controlled, multi-centre study to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in chronic obstructive pulmonary disease patients with cachexia

Clinical Trials Register.eu (Feb 2013)

Assess the effect of i.v. infusion of BYM338 on muscle volume of the thigh (assessed by MRI) compared to placebo

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To Compare the Pharmacokinetics of Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Clinicaltrials.gov (Feb 2013)

The primary objective of this study is to assess and compare the pharmacokinetics (PK) of Tiotropium delivered via Breath Actuated Inhaler (BAI) (4.5 mcg/day or 9.0 mcg/day), SPIRIVA®, HandiHaler®, (18 mcg/day) and Respimat® Soft Mist™ Inhaler (SMI) (5.0 mcg/day) following repeat dosing for 7 days in subjects with COPD.

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A randomized, multi-center, double-blind, doubledummy, parallel group study to evaluate the efficacy and safety of umeclidinium bromide/vilanterol compared with fluticasone propionate/salmeterol over 12 weeks in subjects with COPD

Clinical Trials Register.eu (Jan 2013)

Compare the efficacy and safety of UMEC/VI Inhalation Powder (62.5/25mcg once daily) with fluticasone propionate/salmeterol (500/50mcg twice-daily) over 12 weeks in subjects with COPD who have a history of infrequent COPD exacerbations

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Effect of Glococorticosteroids on physical performance in patients with chronic obstructive pulmonary disease and acute inflammatory response after exercise

Clinical Trials Register.eu (Jan 2013)

The purpose of this trial is to investigate the effects of the drugs prednisone and Solu-Medrol on physical performance in patients with COPD

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A 52-week treatment, multi-center, randomized, double-blind, double-dummy, parallel-group, active controlled study to compare the effect of QVA149 (indacaterol maleate / glycopyrronium bromide) with salmeterol/fluticasone on the rate of exacerbations in subjects with moderate to very severe COPD.

Clinical Trials Register.eu (Jan 2013)

To demonstrate that QVA149 (110/50 μg o.d.) is at least noninferior to salmeterol/fluticasone (50/500 μg b.i.d.) in terms of rate of COPD exacerbations (mild/moderate/severe) during 52 weeks of treatment.

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Intervention Study to Investigate Supplemental Oxygen in COPD

Clinicaltrials.gov (Jan 2013)

The purpose of this trial is to study the effects on exercise capacity, physical activity, inflammatory markers and quality of life of supplemental ambulatory oxygen, to be used during physical activity, in patients with COPD who are normoxic at rest but hypoxemic during a six-min walk test. Our hypothesis is that if patients are able to use supplemental oxygen they will be more physically active and thereby improve health related quality of life.

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A 12-week treatment, multi-center, randomized, double-blind, parallel group, placebo and active controlled study to assess the efficacy, safety, and tolerability of QVA149 (indacaterol maleate /glycopyrronium bromide) in COPD patients with moderate to severe airflow limitation

Clinical Trials Register.eu (Jan 2013)

To demonstrate the superiority of QVA149 27.5/12.5 μg b.i.d. compared to monotherapy components, QAB149 27.5 μg b.i.d. and NVA237 12.5 μg b.i.d., in terms of standardized FEV1AUC0-12 at Week 12.

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A Multicenter Trial Comparing the Efficacy and Safety of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily with Tiotropium 18 mcg Once Daily over 24 Weeks in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trials Register.eu (Dec 2012)

The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg) once-daily with tiotropium (18 mcg) once-daily over 24 weeks for the treatment of subjects with COPD.

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The Effects of Atorvastatin Treatment in COPD Patients

Clinicaltrials.gov (Dec 2012)

This study aims to determine whether statins have an anti-inflammatory effect on the lungs of patients with COPD.

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Ambulatory Oxygen Effects on Muscles in COPD (OM-COPD)

Clinicaltrials.gov (Nov 2012)

Patients with chronic obstructive pulmonary disease (COPD) may develop low oxygen levels, because of damage to their lungs. Long term oxygen therapy (LTOT) is given for at least 15 hours per day, and has established indications and benefits in COPD. However, the indications for and benefits from ambulatory oxygen supplementation (oxygen just when walking or exercising) are less well understood, in part due to heterogeneity of previous study designs, and lack of long term follow up. This is a pilot study of supplementary ambulatory oxygen in COPD, which allows us to ascertain mechanisms of disease by measuring their degree of systemic inflammation pre and post oxygen supplementation, and measuring changes in gene expression in muscles by means of microarray profiling. Secondly, our study will utilise follow up of clinical parameters including home activity monitoring to ascertain medium/long term benefits of oxygen supplementation in a real life setting. Our hypothesis is that exertional hypoxia results in muscle dysfunction and this could be prevented by oxygenation.

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Nitrate, Chronic Obstructive Pulmonary Disease (COPD) and Exercise

Clinicaltrials.gov (Oct 2012)

Patients with moderate chronic obstructive pulmonary disease (COPD) typically have reduced exercise capacity. This is because their lungs are damaged and because of increased work of breathing. In some patients, exercise capacity is reduced to such a level that even simple activities of daily living, such as washing and dressing, may impose a challenge. Recent findings in healthy young people suggest that increasing the amount of nitrate in our diet in the form of beetroot juice can improve the ability to exercise. Studies involving cycling have shown that less oxygen is needed to perform the same level of exercise after taking more nitrate in the diet. Nitrate (found in abundance in beetroot) is known to be converted in the body to nitric oxide (NO), a substance which increases blood flow and may affect the energy-producing mechanisms inside muscle cells. A recent exciting finding is that such dietary nitrate supplementation appears to reduce the amount of oxygen needed to complete moderate intensity exercise (walking) in healthy individuals. It is the purpose of this study to see if such effects could be seen in COPD patients. If this is indeed the case, then it may suggest that a period of dietary supplementation of a relatively cheap, widely available, and natural food product may improve the ability of patients to undergo everyday tasks and ultimately improve their quality of life. To help investigators understand the effects of dietary nitrate supplementation on the ability to exercise in COPD patients, the investigators will recruit 15 people with mild to moderate disease. They will complete a series of undemanding exercise tests on three separate occasions. On one occasion they will have had a course of nitrate rich beetroot juice leading up to the tests, and on the other occasion they will have had a course of beetroot juice with the nitrate removed. The investigators will monitor blood pressure, levels of nitrate and nitrite in the blood, oxygen uptake and functional capacity during the tests which will allow us to assess any effects that may have occurred as a result of increased nitrate intake.

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Prognosis and Treatment of COPD in Primary Care-use of Biomarkers (PROTECCT-M)

Clinicaltrials.gov (Sep 2012)

This is an observational study in primary care aiming to validate biomarkers for chronic obstructive pulmonary disease (COPD).

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Effects of Sulfur Thermal Water Inhalation on Airway Oxidative Stress in COPD Patients

Clinicaltrials.gov (Aug 2012)

The aim of this in vivo study is to evaluate the modulatory effects of sulfur thermal water inhalation on oxidant stress in the airways of stable COPD patients.

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Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)

Clinicaltrials.gov (Aug 2012)

Patients with chronic obstructive pulmonary disease (COPD) have an increased risk of cardiovascular disease,osteoporosis, muscle wasting and diabetes mellitus. Cardiovascular disease is a major cause of death in such patients and it may be related to excess stiffening of the walls of major arteries, such as the aorta, and it has been suggested to represent premature aging. However, there is little known of the development of these problems, which were previously considered to be due to smoking and which is now known not to be the only factor. The investigators will study a large group of patients with mild to very severe airflow obstruction based on the NICE 2010 classification of severity and a matched comparator group free of COPD. This study involves three assessments of the development of the complications of COPD over a five year period. The key measure will be the rate of change in the aortic wall stiffness, an accepted indicator of the risk of heart disease. Changes in wall stiffness will be related to the severity of lung disease; other known cardiovascular risk factors, such as high blood pressure, increased blood cholesterol and to cardiovascular events including heart attacks and death; and to the presence of other complications, such as osteoporosis, muscle wasting and diabetes mellitus. These measures will be analysed in the context of changes in bodywide inflammation and metabolic function and the changes in the rate of ageing. This increased knowledge of interacting factors in the complications of COPD is likely to lead to studies of treatments to avoid their development.

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Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With COPD

Clinicaltrials.gov (Jul 2012)

The purpose of this project is to investigate whether a 12-week, fulltime pulmonary rehabilitation program can enhance cognitive functioning, mood, anxiety, and quality of life in patients with Chronic Obstructive Pulmonary Disease (COPD).

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Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Clinicaltrials.gov (Jul 2012)

To compare the efficacy, safety and pharmacokinetics of QMF149 delivered via Concept1 to salmeterol xinafoate/fluticasone propionate delivered via Accuhaler in adult patients with COPD

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Estimation of the VQ11 Auto-questionnaire, to Follow Patients With Chronic Obstructive Pulmonary Disease (EPIC)

Clinicaltrials.gov (Jun 2012)

The main objective is to compare the total Score of the VQ11 auto-questionnaire before and after LABD. A decrease of 5 points of the total score mimicking an improvement in the quality of life linked to health, specifically in the COPD.

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AVAPS-AE Algorithm in Chronic Obstructive Pulmonary Disease (COPD)Patients (AVAPS-AE COPD)

Clinicaltrials.gov (May 2012)

The purpose of this study is to evaluate the performance of AVAPS AE therapy in COPD patients during nocturnal ventilation.

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Multi-centre Study to Assess the Efficacy and Safety of AZD5423 in COPD Patients on a Background Therapy of Formoterol

Clinicaltrials.gov (Mar 2012)

The purpose of the study is to assess the efficacy and safety of two staggered dose levels of inhaled once daily AZD5423 or twice daily budesonide for 12 weeks in COPD patients on a background therapy of formoterol.

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Monitoring Chronic Obstructive Pulmonary Disease Patients at Home by a Forced Oscillation Technique Device

Clinicaltrials.gov (Mar 2012)

The purpose of this study is to measure daily variability of FOT data measured at home of a group of COPD patients in order to identify possible correlations between symptoms change, breathing pattern, lung mechanical impedance and occurrence of exacerbation.

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Exploratory Phase II Clinical Trial Comprising Biomarker Analysis of Oxaliplatin Plus Fluorouracil/Leucovorin (FOLFOX) in Combination With Bevacizumab (Bvz) in First Line Treatment of Metastatic Colorectal Cancer (CRC) Expressing Mutant K-ras - AC-ANGIOPREDICT

Clinicaltrials.gov (Feb 2013)

The primary objective is to validate previously identified predictive/prognostic genomic DNA and expression biomarkers of response to combination bvz treatments in K-ras mutant advanced CRC (a CRC) or metastatic CRC (mCRC).

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Assessment of Clinical Practice Administration of Chemotherapy and Anti-angiogenic Agent (Bevacizumab) in Colorectal Cancer

Clinicaltrials.gov (Feb 2013)

Investigators propose to assess, retrospectively (from 1/7/2009) and prospectively (up to 31/12/2013,) the safety and tolerability profile (number of participants with adverse events) of standard chemotherapy and anti-angiogenic agent bevacizumab (Avastin) as first line treatment of patients with metastatic Colorectal Cacner with or without KRAS mutation. All treatment schedules that are going to be assessed are considered by the international guidelines as standard therapy for patients with metastatic Colorectal Cacner.

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Feasibility of Microdialysis (MTM COLON I)

Clinicaltrials.gov (Feb 2013)

The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery.

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Physiological Effects of Altering Cancer-related Inflammation

Clinicaltrials.gov (Jan 2013)

This prospective pilot study will examine whether the previously reported effects of NSAIDs on colorectal cancer may be modulated through alterations in tissue gene expression, up regulation of local immune cell infiltrates or down-regulation of the systemic inflammatory response.

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An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (Koralle)

Clinicaltrials.gov (Jan 2013)

This observastonal multicenter study will evaluate the differences of progression-free survival in defined subgroups of patients with metastatic colorectal cancer receiving Avastin (bevacizumab). Further, safety and efficacy in daily routine will be assessed. Data will be collected for up to 5 years.

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Laparoscopic Surgery Equivalent to Open Surgery in Right Colon Cancer Surgery? (CHIRCOL)

Clinicaltrials.gov (Jan 2013)

The primary goal of this study is to compare in the long-term costs of laparoscopic or open right colectomy in patients sustaining a colon cancer controling for the carcinologic equivalence of the two surgical strategies. The secondary goals to compare long-term mortality, morbidity as well as quality of life of the two groups.The present study is an prospective multicentric observational trial taking into account the usual surgical strategy of every centers

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A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer (PACER)

Clinicaltrials.gov (Jan 2013)

The purpose of this study is to assess if panitumumab is active enough to warrant comparative studies in patients with metastatic colorectal cancer that has progressed after treatment with cetuximab.

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Tumor Bank for Blood Samples

Clinicaltrials.gov (Jan 2013)

Establishment of a tumor bank, consisting of blood samples of tumor patients and healthy people as controls. The blood samples will be collected systematically together with the corresponding clinical data. The biological samples, the clinical date together with prospective experimental date constitute the entity of the tumor bank.

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Endocuff Adenoma Detection Rate Pilot Study

Clinicaltrials.gov (Jan 2013)

Colorectal cancer is the second leading cause of cancer deaths in the UK(1) . Detection of cancer at an early stage, as well as detection and removal of polyps through gold standard colonoscopy examination decreases mortality from the disease. However colonoscopy has a well documented miss rate, with some areas of the bowel difficult to visualise and neoplastic lesions potentially hidden behind folds in the colon. The Endocuff© is a disposable polymer sleeve with hinged lateral arms. The arms flatten mucosal folds and fix the colonoscope centrally in the bowel lumen allowing controlled withdrawal and improving mucosal visualization. The cap easily attaches to the tip of current colonoscopes without modification. In this single centre, randomised controlled trial, the investigators aim to assess the performance of the current gold standard colonoscopic examination against the current gold standard colonoscopic examination with the Endocuff© attached to the colonoscope.

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Assessment of Clinically Related Outcomes and Biomarker Analysis for Translational Integration in Colorectal Cancer (ACROBATICC)

Clinicaltrials.gov (Jan 2013)

A prospective, observational study on clinical outcomes of surgical management of primary and metastatic colorectal cancer Prospective collection of tissues to explore potential biomarkers in blood and/or primary or secondary cancers and/or normal colon Prospective collection of patient reported outcome measures (PROMs)

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A Phase II Study to evaluate activity and toxicity of Gemcitabine in Combination with Pemetrexed long term infusion in the Treatment of pretreated Metastatic Colorectal Cancer Patients

Clinical Trials Register.eu (Aug 2012)

The primary objective of the study is to determine the objective response rate (ORR: CR+PR+SD)

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A phase II, multicenter, open-label, randomized study evaluating the efficacy and safety of folfiri + MEHD7945QA versus folfiri + cetuximab in second line in patients with KRAS wild-type metastatic colorectal cancer

Clinical Trials Register.eu (Jul 2012)

1-To evaluate the efficacy, as measured by PFS, of FOLFIRI + MEHD7945A (administered every 2 weeks) versus FOLFIRI + cetuximab (administered weekly) in patients with KRAS wild-type mCRC 2- To evaluate the efficacy, as measured by PFS, of FOLFIRI + MEHD7945A (administered every 2 weeks) versus FOLFIRI + cetuximab (administered weekly) in patients with KRAS wild-type mCRC whose tumors express low levels of HER3

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Open-Label, Phase II Study of Trastuzumab in Combination with Lapatinib or Pertuzumab in Combination with Trastuzumab in Patients with HER2-positive Metastatic Colorectal Cancer: the HERACLES Trial (HER2 Amplification for Colo-rectaL Cancer Enhanced Stratification)

Clinical Trials Register.eu (Jul 2012)

Define the antitumor activity of the anti-HER2 combinations of lapatinib + trastuzumab and pertuzumab + trastuzumab given to two separate, sequential cohorts of patients with chemo-refractory advanced disease and HER2 amplified tumours.

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Randomized, double-blind, phase 3 study of TAS-102 plus best supportive care (bsc) versus placebo plus bsc in patients with metastatic colorectal cancer refractory to standard chemotherapies

Clinical Trials Register.eu (Jun 2012)

To compare the following endpoints for the TAS-102 (experimental) arm with the placebo (control) arm in patients with refractory metastatic colorectal cancer: Overall survival (OS) Progression-free survival (PFS) Safety and tolerability

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A Phase I / II Dose Escalation and Randomised Controlled Trial of ColoAd1 Administered by Sub-acute Fractionated Intravenous Injection to Patients with Metastatic Colorectal Cancer

Clinical Trials Register.eu (Jun 2012)

Phase I: - To evaluate the safety and tolerability of ColoAd1, when administered by sub-acute fractionated IV injection to patients with advanced or metastatic epithelial solid tumours not responding to standard therapy or for whom no standard treatment exists - To determine the maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of ColoAd1 when administered by sub-acute fractionated intravenous (IV) injection to patients with advanced or metastatic epithelial solid tumours not responding to standard therapy or for whom no standard treatment exists, and to recommend a dose for phase II studies. Phase II: - To evaluate the progression free survival (PFS) in patients with metastatic colorectal cancer, who receive ColoAd1 administered by sub-acute fractionated IV injection as an intensification of first line chemotherapy compared with first line chemotherapy alone.

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A Multicenter, Single arm, Open Label Clinical Trial to Evaluate the Safety and Health-Related Quality of Life of Aflibercept in Patients with Metastatic Colorectal Cancer (mCRC) Previously Treated with an Oxaliplatin-Containing Regimen

Clinical Trials Register.eu (Jun 2012)

To evaluate the safety of aflibercept in patients with metastatic Colorectal Cancer (mCRC) treated with irinotecan/5FU combination (FOLFIRI) after failure of an oxaliplatin based regimen (patients similar to those evaluated in the VELOUR trial)

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Use of acetylsalicylic acid (ASA) for enhanced early detection of colorectal neoplasms

Clinical Trials Register.eu (May 2012)

To evaluate diagnostic performance (sensitivity, specificity, positive and negative predictive values, likelihood ratios, area under the curve) of 2 immunochemical Fecal Occult Blood Tests (iFOBTs) for detecting advanced colorectal neoplasms after a single dose of acetylsalicylic acid as compared to placebo

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A randomized phase II study of Bevacizumab/mFOLFOX6 vs. Bevacizumab/FOLFIRI with biomarker stratification in patients with previously untreated metastatic colorectal cancer

Clinical Trials Register.eu (May 2012)

To assess whether: • Expression of chemotherapy resistance marker ERCC-1 is associated with progression-free survival (PFS) in first-line metastatic colorectal cancer (CRC) patients treated with bevacizumab in combination with mFOLFOX6 or FOLFIRI • Plasma level of vascular endothelial growth factor A (VEGF-A) as a potential biomarker for bevacizumab, and in combination with ERCC-1 expression as a chemotherapy regimen biomarker, is associated with different PFS

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A Phase IIA Open Label, Adaptive, Randomized Clinical Trial of Dalotuzumab (MK-0646) Treatment in Combination with Irinotecan Versus Cetuximab and Irinotecan for Patients with Metastatic Rectal Cancers (mRC) Expressing High IGF-1/Low IGF-2 Levels

Clinical Trials Register.eu (May 2012)

To compare PFS of patients with wtKRAS mRC with High IGF-1/Low IGF-2 levels when treated with Dalo + Irino relative to patients treated with Cetux + Irino

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A perioperative, single-arm multicenter Phase II academic trial to investigate the efficacy and safety of panitumumab in combination with irinotecan/5-fluorouracil/leucovorin (FOLFIRI) in patients with previously untreated, wild-type KRAS, potentially resectable colorectal cancer liver metastases

Clinical Trials Register.eu (May 2012)

Objective response rate (ORR) and safety

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A Phase IIA Open Label, Adaptive, Randomized Clinical Trial of Dalotuzumab (MK-0646) Treatment in Combination with Irinotecan Versus Cetuximab and Irinotecan for Patients with Metastatic Rectal Cancers (mRC) Expressing High IGF-1/Low IGF-2 Levels

Clinical Trials Register.eu (Apr 2012)

To compare PFS of patients with wtKRAS mRC with High IGF-1/Low IGF-2 levels when treated with Dalo + Irino relative to patients treated with Cetux + Irino

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FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema

National Cancer Institute (Apr 2012)

The purpose of this interventional study is to assess the progression free survival (one year) of patients with treatment of FOLFIRI and cetuximab, combined with an optional dermal prophylaxis.

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Individualised first line chemotherapy in metastatic colo-rectal cancer (mCRC). Is plasma TIMP-1 a predictive factor for best choise of first line chemotherapy in mCRC?

Clinical Trials Register.eu (Apr 2012)

Aim is to investigate whether or not the cancer marker plasma TIMP-1 is related to probability of treatment response on chemotherapy with or without irinotecan

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New Adjuvant Chemotherapy of Non Resectable Liver Metastasis of Colorectal Cancer Without Bleeding, Obstruction

National Cancer Institute (Apr 2012)

Evaluation of new adjuvant chemotherapy for unresectable liver metastasis of colorectal cancer without bleeding, obstruction, etc.

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An open-label phase IIIb study of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy

Clinical Trials Register.eu (Mar 2012)

To provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed all approved standard therapies and to assess the safety of regorafenib

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A Phase II study of neoadjuvant chemotherapy given before SCPRT as treatment for patients with MRI-staged operable rectal cancer at high risk of metastatic relapse

Clinical Trials Register.eu (Mar 2012)

The principal reasearch question is whether in MRI-defined operable rectal cancer patients, it is feasible to treat for eight weeks with oxaliplatin/5-Fluorouracil chemotherapy and then give a short course of preoperative radiotherapy (SCPRT)immediately before surgical removal of the tumour. This will be measured by calculating the proportion of patients successfully completing surgery.

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An open-label phase IIIb study of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy

Clinical Trials Register.eu (Mar 2012)

The main objectives of this study are (I) to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed all approved standard therapies and (II) to assess the safety of regorafenib

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A single arm study in metastatic colorectal cancer patients treated with pharmacokinetically (PK) dose adjusted weekly or biweekly 5-fluorouracil (5-FU) regimes.

Clinical Trials Register.eu (Feb 2012)

To determine whether pharmacokinetically-guided dose adjustment of 5-FU provides a stable intrapatient dose level of 20-30 mg.h /l. The primary analysis will be the comparison of the proportion of patients with AUC within 20 to 30 mg.h/L after the first 5-FU application versus the fourth application.

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Iron Therapy in Colo-Rectal Neoplasm and Iron Deficiency Anemia: Intravenous Iron Sucrose Versus Oral Ferrous Sulphate.

National Cancer Institute (Jan 2012)

The main objective of this study is to evaluate the efficacy of intravenous iron sucrose in increasing preoperative haemoglobin values in patients with colo-rectal neoplasm and iron deficiency anemia, compared to the standard treatment with oral iron. It will also determine whether intravenous iron sucrose administration improves outcomes such as postoperative haemoglobin values, serum ferritin values, transfusional needs, postoperative complications, or length of hospital stay.

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Transhepatic Arterial Chemotherapy (TAC) Versus Transcatheter Arterial Chemoembolization (TACE) Plus Folfox4 as the Treatment of Unresectable Liver Metastasis of Colorectal Cancer

National Cancer Institute (Jan 2012)

The purpose of this study is to investigate whether TAC plus FOLFOX4 or TACE plus folfox4 are able to improve resection rate and overall survival in patients receiving primary colorectal tumor resection than given FOLFOX4 only.

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Potentially resectable metastatic colorectal cancer with wild-type KRAS and BRAF: alternating chemotherapy plus cetuximab - A randomised phase II trial - Nordic 8

Clinical Trials Register.eu (Jan 2012)

The purpose of this study is to assess the response rate

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Perioperative FOLFOXIRI and bevacizumab compared with postoperative FOLFOX in patients with resectable liver metastases from colorectal cancer (PERIMAX).

Clinical Trials Register.eu (Dec 2011)

The primary objective of this study is to evaluate the efficacy of 5-Fluorouracil (5-FU) and oxaliplatin (FOLFOX-Regimen) for 6 months postoperatively compared to 5-FU, oxaliplatin and irinotecan (FOLFOXIRI-Regimen) with bevacizumab for three months pre- and three months postoperatively for resectable liver metastases from colorectal cancer.

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Correlation Between RECIST-conventional Imaging Techniques, Morphologic Response by CT- Histopathologic Response in Hepatic Metastasis Secondary to Colorectal Cancer

National Cancer Institute (Dec 2011)

The purpose of this study is to to evaluate the correlation of overall objective response according to RECIST v1.1. criteria evaluated by conventional imaging techniques, morphologic response by CT, and histopathologic response in patients with resectable hepatic metastasis secondary to colorectal cancer treated with bevacizumab in combination with XELOX.

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Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia

National Cancer Institute (Dec 2011)

The investigators seek to compare two techniques of removing pre-cancerous lesions from the colon. The investigators also will compare two solutions used during the procedure to determine if either solution allows for an improved removal of the tumors.

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Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer

National Cancer Institute (Dec 2011)

The purpose of this study is to investigate whether preoperative TAC is able to improve progression free survival and overall survival in patients receiving liver metastasis resection of colorectal cancer.

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Preoperative Assessment of Colon Tumor

National Cancer Institute (Dec 2011)

The purpose of this study is to determine whether a colonic tumor can be classified as malignant or benign with magnetic resonance (MR) colonography. Patients with a verified colon carcinoma or benign tumor based on diverticulitis are offered a MR colonography with intravenous (I.V.) contrast. The tumor is classified as malignant or benign by assessing the dynamic contrast uptake and morphology. The Investigator is blinded from the verified diagnosis and the MR classification is compared to the histological diagnosis.

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A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination with mFOLFOX6 with Bevacizumab in Combination with mFOLFOX6 in Stage IV Metastatic Corectal Cancer (mCRC) Subjects

Clinical Trials Register.eu (Dec 2011)

To compare progression-free survival (PFS) between tivozanib in combination with mFOLFOX6 with bevacizumab in combination with mFOLFOX6 based on investigator radiological tumor assessment.

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A Phase II, Single Arm, Investigative Study of IMM-101 in Combination with Radiation Induced Tumour Necrosis in Patients with Previously Treated Colorectal Cancer

Clinical Trials Register.eu (Dec 2011)

To investigate the efficacy of IMM-101 in combination with radiation induced tumour necrosis (induced by CyberKnife treatment) in patients with colorectal cancer with metastatic disease who have received prior chemotherapy.

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A multi-center, randomized, open-label, mechanism of action trial on the biological effects of the therapeutic cancer vaccine Stimuvax® (L-BLP25) in rectal cancer subjects undergoing neoadjuvant chemoradiotherapy. Stimuvax® (L-BLP25) in rectal cancer in neoadjuvant chemoradiotherapy (SPRINT)

Clinical Trials Register.eu (Jun 2011)

The primary objective of the trial is to evaluate whether L-BLP25 administered as weekly subcutaneous vaccinations with or without pretreatment with intravenous cyclophosphamide (CPA) induces a change in immune response parameters (ELISpot against carcinoembryonic antigen [CEA] and mucinous glycoprotein 1 [MUC1], tumor-infiltrating lymphocytes [TILs]) in subjects with rectal cancer undergoing neoadjuvant chemoradiotherapy. The immune response will be evaluated based on the local response in the tumor and the MUC1- and CEA-specific response tested in blood. CEA-specific immune response will indicate antigen spreading.

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Ultrasound Elastography in Patients With Rectal Cancer

Clinicaltrials.gov (Jun 2011)

The purpose is to elucidate ultrasonic elastography's ability to predict treatment response at an early stage by comparing quantitative ultrasound parameters before, during and after treatment with MR scan results and histopathological Tumor Regression Grade (TRG score) after operation.

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Randomized Multicentre Phase III study of short course radiation therapy followed by prolonged pre-operative chemotherapy and surgery in primary high risk rectal cancer compared to standard chemoradiotherapy and surgery

Clinical Trials Register.eu (Apr 2011)

To increase the disease-free survival after 3 years follow-up

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Optimal Surgery and MRI Based Radiochemotherapy in Rectal Carcinoma (OCUM)

Clinicaltrials.gov (Mar 2011)

The objective of the study is to provide proof that a MRI based preoperative radiochemotherapy in patients with locally advanced rectal carcinoma allows limiting RCT to high risk patients without increase of locoregional recurrence rate and decrease of overall survival provided there is a high quality of mesorectal excision.

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Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery Versus Total Mesorectal Excision in T2-T3s N0, M0 Rectal Cancer

Clinicaltrials.gov (Mar 2011)

To compare the results of local recurrence at 2 years in patients treated with preoperative chemoradiotherapy and TEM and in patients treated with conventional radical surgery (TME).

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Colorectal Cancer Detection by Means of Optical Fluoroscopy

Clinicaltrials.gov (Jan 2011)

The aim of the present prospective study was to investigate the fluorescence emission of human blood plasma of patients with colorectal cancer. For years, serum tumor markers have been studied for the diagnosis and follow-up of colorectal cancer, among which carcinoembryonic antigen (CEA) has achieved promising results. However, the sensitivity of CEA for colorectal cancer is less than 25% and elevated CEA levels also occur in patients with benign disease, as well as in patients with other carcinomas. Nevertheless, surveillance programs are often based on the CEA test and combination with other markers is at present a matter of research. Alternative methods based on optical fluoroscopy have been introduced in experimental stages for clinical diagnosis of cancer. Few studies have been reported on the application of native fluorescence spectroscopy of biofluids in the diagnosis of tumoral diseases. The above reported findings prompted us to investigate the fluorescence emission of human blood plasma of patients with colorectal cancer. For this purpose, the blood of patients was collected and the fluorescence Preliminary measurements on plasma of patients bearing colon cancer showed that the fluorescence spectra were mainly characterized by the presence of an emission peaking at 620-630 nm, whose excitation spectrum peaked at 405 nm. Hence, an excitation wavelength of 405 nm was selected for the study. The fluorescence emission spectra were recorded in the range of 430-700 nm.

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Neoadjuvant radiotherapy combined with capecitabine and sorafenib in patients with advanced, K-ras mutated rectal cancer. A randomized multicenter phase I/II trial.

Clinical Trials Register.eu (Dec 2010)

Part I: to determine the recommended dose of the neoadjuvant regimen of capecitabine, sorafenib and external beam radiotherapy in patients with advanced K-ras mutated rectal cancer. Part IIa: to assess the efficacy and safety of the neoadjuvant regimen of capecitabine, sorafenib and external beam radiotherapy in patients with advanced K-ras mutated rectal cancer.

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Cytokine Changes After Colorectal Cancer Resection

Clinicaltrials.gov (Nov 2010)

Based on our previous research, this study aims to determine reliable surgical stress response markers in patients undergoing radical resection of colorectal cancer.

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AIO KRK 0109 - An open-label 2:1 randomized phase II study of panitumumab plus FOLFOXIRI or FOLFOXIRI alone as first-line treatment of patients with non-resectable metastatic colorectal cancer and k-ras wild type (VOLFI)

Clinical Trials Register.eu (Oct 2010)

To assess efficacy (overall response rate, ORR) of adding panitumumab to FOLFOXIRI in selected. I) patients with definitively unresectable metastatic disease, with a focus on symptomatic metastatic disease and/or large tumor load, or II) patients with chance of secondary resection with curative intent according to recent S3 guidelines of the German Cancer Society. The ORR will be compared to expectations derived from historical data, which are verified by a randomised control group without the antibody.

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ARISTOTLE - A phase III trial comparing standard versus novel CRT as pre-operative treatment for MRI defined locally advanced rectal cancer.

Clinical Trials Register.eu (Aug 2010)

This trial will determine whether the addition of a second drug (irinotecan) to the standard treatment of oral chemotherapy using capecitabine and radiotherapy will result in fewer cancer recurrences (regrowth) after the operation and if patients live longer.

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SONATINA: A Phase II Multi-Centre Randomised Controlled Study of Nelfinavir Addition to Radiotherapy Treatment in Neo-Adjuvant Therapy for Rectal Cancer

Clinical Trials Register.eu (Aug 2010)

To investigate the activity of the drug, Nelfinavir, when it is used to sensitise rectal cancer to radiotherapy treatment to try to make the radiotherapy more effective.

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Intérêt d'un traitement par cyclines dans la prévention de la toxicité cutanée du Cétuximab lors de son association à un FOLFIRI intensifié chez des patients avec un cancer colorectal en première ou deuxième ligne métastatique. Etude ouverte, multicentrique, randomisée, de phase III : SKINUX

Clinical Trials Register.eu (Jul 2010)

Diminution de 30% de l'incidence de la toxicité cutanée à type d'éruption acnéiforme de grade supérieur ou égal à 2 lors d'un traitement préventif par cyclines pendant 6 semaines.

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Quality of Life in Patients After Combined Modality Treatment of Rectal Cancer

Clinicaltrials.gov (Jun 2010)

The goal of this study is gathering informations about patients' quality of life after combined modality treatment of rectal cancer to evaluate how combined modality treatment for rectal cancer affects patients' quality of life

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Panitumimab in combination with radiotherapy in patients with locally advanced KRAS wildtype rectal cancer (clinical stages II and III)

Clinical Trials Register.eu (Jun 2010)

The primary objective of the study is to estimate the efficacy of panitumumab concurrent to radiotherapy in patients with wild-type KRAS. The rate of pathological complete remissions will be compared to expectations derived from historical data.

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Chemoradiotherapy for rectal cancer in the distal rectum followed by organ-sparing transanal endoscopic microsurgery

Clinical Trials Register.eu (Apr 2010)

The primary objective of the study is to determine the number of patients with minimal residual disease (ypT0-1) after neoadjuvant chemoradiation followed by TEM surgery. The resection specimen should be complete (> 2 mm margin) without evidence of nodal metastases (if nodes are found).

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A randomized, double-blind, placebo-controlled phase III study of regorafenib plus BSC versus placebo plus BSC in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy

Clinical Trials Register.eu (Apr 2010)

To evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapies. The primary efficacy endpoint of this study is Overall survival

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Estudio fase II de Bevacizumab en combinación con Capecitabina y radioterapia como tratamiento preoperatorio en pacinetes con cáncer rectal localmente avanzado resecable.

Clinical Trials Register.eu (Mar 2010)

Evaluar la eficacia del tratamiento neoadyuvante con Bevacizumab, administrado bisemanalmente de forma concomitante con capecitabina y radioterapia externa, medida como tasa de respuesta patológica completa.

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A randomized, double-blind, placebo-controlled phase III study of regorafenib plus BSC versus placebo plus BSC in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy

Clinical Trials Register.eu (Feb 2010)

To evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapies. The primary efficacy endpoint of this study is Overall survival.

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Safety and efficacy of the addition of simvastatin to cetuximab in k-ras mutant advanced or metastatic colorectal cancer patients. A single-arm, multicenter, phase II study using a Simon two stage design.

Clinical Trials Register.eu (Feb 2010)

To investigate the efficacy of the addition of simvastatin to cetuximab in k-ras mutant advanced or metastatic colorectal cancer patients.

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Onderzoek naar de farmacokinetiek van uracil na orale toediening bij patiënten met colorectaal carcinoom : KINURA-2

Clinical Trials Register.eu (Jan 2010)

To determine that de PK of an oral uracil loading dose in patients with colorectal cancer and normal DPD activity does not differ from the PK in healthy volunteers.

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An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate an Pemetrexed Single Agent given as Neoadjuvant Treatment in Patients with Resectable Rectal Cancer

Clinical Trials Register.eu (Jan 2010)

Evaluation of optimal dose of Methylenetetrahydrofolate (Modufolin) in combination with a fixed dose of Pemetrexed (Alimta) 500mg/m2 related to the safety margins as described.

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El-porCEA: Assessment of safety and immunogenicity of intradermal electroporation of tetwtCEA DNA in patients with colorectal cancer.

Clinical Trials Register.eu (Jun 2009)

To evaluate the safety and immunogenicity of a DNA immunisation approach where tetwtCEA DNA will be administered in combination with electroporation

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Phase II Study of Preoperative Panitumumab and External Beam Radiotherapy in Patients with Locally Advanced Rectal Cancer

Clinical Trials Register.eu (May 2009)

To investigate the antitumor activity of panitumumab in combination with preoperative external beam radiotherapy in patients with locally advanced rectal cancer, followed by surgery and adjuvant chemotherapy.The primary objective is the complete pathological response of the tumor.

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A randomized phase II study of oxaliplatin and capecitabine combination vs irinotecan and capecitabine combination for the treatment of elderly patients with advanced colorectal cancer.

Clinical Trials Register.eu (May 2009)

The objective of this study is to compare the effectiveness of oxaliplatin and capecitabine combination vs irinotecan and capecitabine combination for the treatment of elderly patients with advanced colorectal cancer.

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A phase I/II trial testing nelfinavir, an inhibitor of Akt signaling, in combination with preoperative chemoradiotherapy in patients with locally advanced rectal cancer

Clinical Trials Register.eu (Sep 2008)

To investigate the safety and the activity of nelfinavir, administered before and during preoperative chemoradiotherapy, 28x1.8 Gy in combination with Xeloda 825 mg/m2 BID, in patients with locally advanced rectal carcinoma.

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A randomized phase II of bevacizumab, capecitabine and radiation therapy with or without oxaliplatin in the preoperative treatment of locally advanced rectal cancer

Clinical Trials Register.eu (Sep 2008)

This phase II trial assesses the activity of bevacizumab (Avastin) in combination with capecitabine (Xeloda) and radiation therapy with or without oxaliplatin (Eloxatin) in the pre-operative treatment of locally advanced rectal cancer, followed by TME resection, in a multicenter setting.

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Preoperative Radiotherapy and Local Excision in Rectal Cancer

Clinicaltrials.gov (Aug 2008)

The investigators aim to compare the short-course radiotherapy schedule with the chemoradiation in order to determine an optimal scheme. The study hypothesis is that the chemoradiation assures 25% more patients who do not require conversion to an open surgery. In addition, the aim is to asses safety and efficiency of preoperative radiotherapy and local excision for radiosensitive rectal cancer.

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Collecting Information From Patients and Family Members With Hereditary Colorectal Cancer Syndromes or Who Are at High Risk of Developing Colorectal Cancer

Clinicaltrials.gov (May 2008)

RATIONALE: Gathering medical and family history information from patients and family members may help doctors better understand hereditary colorectal cancer and hereditary polyposis syndrome and identify patients at high risk of developing hereditary colorectal cancer. PURPOSE: This research study is collecting information from patients and family members with hereditary colorectal cancer or polyposis syndrome or who are at high risk of developing hereditary colorectal cancer.

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Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer (PETACC-6)

Clinical Trials Register.eu (Apr 2008)

To investigate whether the addition of oxaliplatin to preoperative fluoropyrimidine-based chemoradiation and postoperative fluoropyrimidine-based chemotherapy improves disease-free survival in patients with locally advanced rectal cancer.

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Treatment Monitoring of Advanced Colorectal cancer with 18F-FDG PET/CT

Clinical Trials Register.eu (Mar 2008)

The objective of this study is to assess the efficacy and safety of 18F-FDG PET/CT in the treatment of patients with colorectal cancer.

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Biological, Genetic, and Lifestyle Risk Factors for Developing Colorectal Adenomas or Polyps in Participants Undergoing Colonoscopy

National Cancer Institute (Feb 2008)

This clinical trial is looking at biological, genetic, and lifestyle risk factors for developing colorectal adenomas or polyps in participants undergoing colonoscopy.

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FLOX + Erbitux. 1. line treatment to patients with metastatic colorectal cancer and wild type K-RAS tumor. A phase II study.

Clinical Trials Register.eu (Feb 2008)

The main objective to the trial is response rate.

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A phase II, double-blind, placebo controlled, randomised study to assess the efficacy and safety of 2 doses of ZACTIMA (ZD6474) in combination with FOLFIRI vs. FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen

Clinical Trials Register.eu (Feb 2008)

The primary objective of this study is to assess the efficacy of ZD6474 (100 mg and 300 mg) in combination with FOLFIRI versus FOLFIRI alone for the treatment of patients with colorectal cancer that have failed prior treatment with oxaliplatin and a fluoropyrimidine by assessment of disease progression.

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Trial of Aspirin and Arginine Restriction in Colorectal Cancer

Clinicaltrials.gov (Dec 2007)

This study is a Phase IIa clinical biomarker study, using oral aspirin 325 mg taken daily with an arginine-restricted diet designed to reduce arginine intake by at least 30% during the 12-week study period. The biomarkers will be obtained from patient by performing endoscopy (a procedure used to look at the inside of the bowel, rectum and colon) and biopsy (taking samples of tissue), phlebotomy (drawing blood), and urine collection. Biopsies are done to evaluate changes in tissue content that may relate to early events in colon cancer formation. This was the procedure used to diagnose your condition initially. There will be 24 patients enrolled into this study performed through University of California Irvine Medical Center.

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Open-label, efficacy and safety study of bevacizumab (Avastin) in combination with XELOX (Oxaliplatin plus Xeloda) for the first-line treatment of patients with locally advanced or metastatic cancer of the colon or rectum -"OBELIX"

Clinical Trials Register.eu (Nov 2007)

To confirm the efficacy of bevacizumab in combination with oxaliplatin and capecitabine (XELOX) based regimen, based on progression free survival

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Pharmacokinetic Perspective Study In Colorectal Cancer Patients And Candidate For Fluoropyrimidine Therapy: 5-Fluoro Test

Clinical Trials Register.eu (Oct 2007)

To evaluate 5-FU e 5-FDHU pharmacokinetic parameters after a test-dose administration (5-FU 250 mg/mq ev. bolus). To analyse possible correlations between pharmacokinetic results and adjuvant or first line treatment tolerability in colorectal cancer patients. To exclude from fluoropyrimidine therapy patients with significant alterations of 5-FU and 5-FDHU pharmacokinetics (CL<1 l/h/mq, T1/2β>5 h, and Cmax<0.1 µg/ml, Tmax>60 min, respectively) after the administration of the 5-FU test-dose.

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Phase II study of neoadjuvant chemoradio therapy in locally advanced rectal cancer

Clinical Trials Register.eu (Sep 2007)

Efficacy evaluation in terms of pathological complete response to neoadjuvant capecitabine, oxaliplatinum and radiation in locally advanced rectal cancer

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Effect of mechanical bowel preparation with polyethylene glycol plus bowel enema (glycerin 5%) vs bowel enema alone in patients candidates to colorectal resection for malignancy. Prospective randomized clinical trial.

Clinical Trials Register.eu (Jul 2007)

The main objective is to determine the incidence of post operative complications.

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Applicability of TachoSil® in sealing rectal anastomoses. A feasibility trial.

Clinical Trials Register.eu (Jul 2007)

The primary objective is to establish a procedure for the application of TachoSil® following establishment of rectal anastomoses. For this purpose a number of no more than15 patients will be included who will all have TachoSil® applied to their rectal anastomoses. If data from less than 15 patients are sufficient to establish a procedure for application of TachoSil® the trial will be stopped before 15 patients are included for evaluation.

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Bevacizumab+folfiri in untreated patients with advanced colorectal cancer. A phase II multicenter study of the Gruppo Oncologico dell'Italia Meridionale. (GOIM).

Clinical Trials Register.eu (Jun 2007)

The main objectives are to determine the objectively confirmed response rate and time-to- progression.

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A Phase II Study of Panitumumab 5-Fluorouracil and Oxaliplatin in combination with pelvic radiotherapy as treatment of resectable and locally advanced rectal cancer (StarPan Study ﾖ STAR 02)

Clinical Trials Register.eu (May 2007)

To assess the complete pathological response rate over the treatment period when panitumumab, 5-fluorouracil and oxaliplatin are administered in combination with external beam radiotherapy in Subjects with untreated resectable and locally advanced rectal cancer

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Proteomic and genetic analysis of neurotoxicity predicting markers in oxaliplatine treated patients with colorectal carcinoma.

Clinical Trials Register.eu (Apr 2007)

Genetic and proteomic analysis of markers looking for relation to neurotoxicity and predictive value.

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A triplet combination with Irinotecan (CPT-11) plus Oxaliplatin (L-OHP), continuous infusion 5-fluorouracil (5-FU) and Leucovorin (LV) (FOLFOXIRI) plus Cetuximab (C-225) as first line treatment in metastatic colorectal cancer (MCC) : A pilot phase II trial.

Clinical Trials Register.eu (Feb 2007)

The main objectives of this trial are to access the following: Objective Response Rate, Resectability Rates, Time to Tumor Progression (TTP), Median Overall Survival (mOS), Toxicity Profile, Pharmacogenomic Analysis, and Q-Twist analysis of Quality of Life.

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NGR006 A phase II study of NGR-hTNF administered as single agent every 3 weeks in patients affected by colorectal cancer CRC , previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens.

Clinical Trials Register.eu (Jan 2007)

Antitumour activity defined as Progression Free Survival.

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A Phase II, Double-Blind, Placebo Controlled, Randomised Study To Assess The Efficacy And Safety Of 2 Doses Of ZACTIMA (ZD6474) In Combination With FOLFOX vs FOLFOX Alone For The Treatment Of Colorectal Cancer In Patients Who Have Failed Therapy With An Irinotecan And Fluoropyrimidine Containing Regimen.

Clinical Trials Register.eu (Jan 2007)

The primary objective of this study is to assess the efficacy of ZD6474 (100 mg and 300 mg) in combination with the modified FOLFOX 6 regimen (mFOLFOX6) versus mFOLFOX6 alone for the treatment of patients with colorectal cancer that have failed prior treatment with irinotecan and a fluoropyrimidine by assessment of disease progression.

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Radio-controlled Surgery RGS in the cancer of the rectum clinical study of feasibility to improve the treatment and prognosis

Clinical Trials Register.eu (Nov 2006)

To demonstrate the effectiveness, the accuracy and sensibility of the technology of the radioisotope in the finding of LS in the cancer of the rectum or its relapses

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Pharmacodynamic study of oral mirtoselect in patients with suspected colorectal disease

Clinical Trials Register.eu (Sep 2006)

The main primary objective is to assess levels of anthocyanins and their metabolites achieved in biomatrices from patients following a seven-day course of oral Mirtoselect.

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An open-label, non-randomized phase I/II trial of neoadjuvant radio-immunochemotherapy with cetuximab and 5-FU for advanced rectal cancer

Clinical Trials Register.eu (Mar 2006)

Phase I part of the trial: define the safe dose of infusional 5-FU in combination with Cetuximab and RT in this setting. Phase II part of the trial: Assessment of the pathological complete response (pCR)

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5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in Stage I/II Rectal Cancer

Clinicaltrials.gov (Mar 2006)

This phase II trial will investigate the combination of adjuvant 5-fluorouracil, radiation, and bevacizumab in patients with stage II and III rectal cancer, followed by FOLFOX6 and bevacizumab. Fluorouracil (FU) has proven to be an effective and safe regimen in the treatment of stage II and III rectal cancer

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INTEnsification Radiotherapy with Accelerated fractionation or ChemoTherapy And Local Excision After 3D External Radio-chemotherapy

Clinical Trials Register.eu (Jan 2006)

Evaluation of T pathological major downstaging, considered as the overall rate of any TRG1 or TRG 2 scored patients; -to evaluate the impact on local control of local excision in patients who had a major clinical response, evaluated by EUS/ MRI, yN0 evaluated by multislice CT / MRI, and confirmed by TRG 1-2 score.

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Acupuncture in Infantile Colic - a Three Armed Randomized Multi Center Trial (ACU-COL)

Clinicaltrials.gov (Dec 2012)

The purpose of this prospective randomized three armed, multi center study is to compare the effect of two types of acupuncture and no acupuncture in 2-8 weeks old infants with infantile colic. Group A will get standardized minimal acupuncture in LI4, group B will get individualized acupuncture in different points according to symptoms and group C will not get acupuncture. Parents (who register the infants crying) and the nurse they meet at the study CHC are blinded.

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Acupuncture Trial for Post Anaesthetic Recovery and Postoperative Pain

Clinicaltrials.gov (Oct 2012)

In the present study, the investigators want to evaluate if press needle acupuncture applied prior to surgery may contribute to the anaesthesiologic outcome. Acupuncture might improve fast-track anaesthesia in the PACU after general surgery.

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Effects of Meditation Awareness Training on Psychosocial Functioning in Prison Participants

Clinicaltrials.gov (Aug 2012)

The purpose of this study is to investigate the effects of an eight-week long group-based secular intervention known as Meditation Awareness Training (MAT) on psychosocial functioning in prison participants.

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Efficacy and Safety Study of Homeopathic Oral Antibodies to Treat Viral Upper Respiratory Tract Infections (ESTUAR)

Clinicaltrials.gov (Jul 2012)

The purpose of this study is to determine whether early self-treatment with homeopathic dilutions of oral antibodies to a key-protein of the immune system are effective and safe in the treatment of viral upper respiratory tract infections

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Hypnosis and Closed-Loop Anesthesia System (LoopHypnosis)

Clinicaltrials.gov (Jul 2012)

Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what extent, hypnosis decreases propofol requirement to induce induction of general anesthesia. A particular aspect of this study is that induction is provided by a closed-loop system which delivers propofol according to bispectral index.

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Hypnotherapy in Patients With Chest Pain & Unobstructed Coronaries

Clinicaltrials.gov (Mar 2012)

This study will investigate whether clinical hypnotherapy can effectively treat chest pain symptoms, improve emotional wellbeing and quality of life in postmenopausal women with chest pain and coronary arteries without any narrowings. The diagnosis of chest pain with 'normal' coronary arteries is found in 25% of patients undergoing investigation of chest pain using coronary angiography (when dye is injected into the coronary arteries whilst xray pictures are taken), and the majority of these patients are postmenopausal women. Often there is no obvious physical cause. Despite symptoms being treated using conventional drugs, and life expectancy is not affected, many patients continue to suffer from debilitating chest pain symptoms, frequently resulting in visits to hospital, increased psychological illness and poor quality of life. The investigators are interested in finding ways of improving not only chest pain symptoms but also psychological wellbeing and quality of life in these patients. Previous studies of ours have found improvement in these patients after taking part in a support group, and using a relaxation technique called Autogenic training. Recently the investigators conducted a pilot study which showed a favourable effect of hypnotherapy on physical ability, well-being and quality of life. The investigators would now like to extend this study, performing a larger randomised, controlled trial. The investigators hypothesise that hypnotherapy will beneficially affect symptoms and quality of life in patients with cardiac Syndrome X.

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Efficacy of Arnica D1 Ointment After Upper Blepharoplasty (ARINE)

Clinicaltrials.gov (Mar 2012)

Arnica ointment is currently used in homeopathic preparations for strains and bruises. In the field of plastic surgery, some surgeons advise patients undergoing blepharoplasty to use Arnica in order to prevent postoperative ecchymosis, swelling and pain. Thus far, no decent study evaluated the efficacy of topical Arnica ointment in reducing ecchymosis or surgical outcome after upper blepharoplasty. We hypothesize that application of Arnica ointment postoperatively will reduce the development of ecchymosis and improve outcome.

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Effectiveness of homeopathic treatment (Agraphis nutans 5CH, Thuya occidentalis 5CH, Kalium muriaticum and Arsenicum iodatum 9CH 9CH) as adjuvant secretory otitis in children

Clinical Trials Register.eu (Feb 2012)

Evaluate the effectiveness of homeopathy coadyuvancia of aerosol treatment (mucolytics, corticosteroids), secretory otitis in pediatric patients 2 months to 12 years, making an intervention group who receive homeopathy and the control group will receive placebo. It will compare the effectiveness measured by pneumatic otoscopy

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Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance (HYPNOC)

Clinicaltrials.gov (Jan 2012)

The study examines prospects of hypnotherapy in reducing agitation in patients after cardiac or spinal column surgery. A particular aim is to point out the effects on postoperative cognitive outcome. Additional blood and urine tests are conducted(concerning cardiac stratum; in cooperation with "Immundiagnostik AG")

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Additive Homeopathy in Cancer Patients (HIC)

Clinicaltrials.gov (Jan 2012)

The investigators aim to investigate the validity of their previous results in a randomized prospective, placebo-controlled, double-blind, multicenter controlled evaluation of questionnaires in patients with advanced malignant tumors. The investigators plan to compare the treatment outcome (quality of life and survival) in tumor patients, receiving standard or "add-on" homeopathic treatment. The null hypothesis is that "add-on" homeopathic treatment does not create a benefit for cancer patients. In addition the investigators evaluate survival time.

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Clinical Value of Homeopathic Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury

Clinicaltrials.gov (Nov 2011)

Recurrent symptomatic urinary tracts infections (UTI) in persons with spinal cord injury are a frequent problem, leading to significant morbidity and to a decreased quality of life. - until today, there is no effective prophylaxis for UTI for patients with spinal cord injury. - homeopathy has been shown to be an effective treatment option in several chronic diseases - study hypothesis: the addition of homeopathic assessment and treatment to a standard prevention strategy for recurrent UTI will significantly reduce the number of symptomatic UTI per year in this group of patients compared to standard prevention alone

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Acupuncture in Acute Nonspecific Low Back Pain (Acuback)

Clinicaltrials.gov (Sep 2011)

Acute low back pain is a common disorder in general practice. Many general practitioners have experienced good effect of acupuncture in the treatment of low back pain, but the evidence is poor. The investigators aim to explore whether acupuncture treatment has effect on time to recovery as an addition to the standard treatment in general practice according to national guidelines. The investigators hypotheses are: - Acupuncture treatment contributes to faster pain reduction in acute low back pain than the standard treatment in general practice provided in accordance with national guidelines. - Acupuncture treatment for acute low back pain improves function, and reduces drug use and sick leave, compared with the standard treatment in general practice provided in accordance with national guidelines. The investigators intend to include a total of 236 patients, 118 in the intervention group and 118 in the control group.

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Prospective, randomized, controlled, open-label study evaluating quality of life in patients with advanced malignant tumors with and without “add-on” homeopathy

Clinical Trials Register.eu (Apr 2011)

Reveal and describe the difference in Qol and SWB, in patient groups receiving standard treatment and “add on” homeopathic treatment. The null hypothesis is that “add-on” homeopathic treatment does not create a benefit for cancer patients with regard to QoL and SWB.

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Study of the Effects of Hypnosis Before Undergoing Surgery, on Anxiety in Children Aged 10 to 18 Years (HYPOPANX)

Clinicaltrials.gov (Mar 2011)

This study aims to find how hypnosis performed just before a painful surgery can change anxiety level, in children aged 10 to 18 years.

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Evaluation of Homeopathic Treatment for Hot Flashes in Non Metastatic Breast Cancer (HBC)

Clinicaltrials.gov (Nov 2010)

The purpose of this study is to evaluate the efficacy of a homeopathic treatment (BRN01) in reducing hot flash scores after 4 weeks of treatment.

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CardioPET as PET Imaging Agent to Assess Myocardial Perfusion and Fatty Acid Uptake in Known or Suspected CAD Subjects

Clinicaltrials.gov (Apr 2013)

The study is designed to evaluate how safe and how well an investigational imaging product CardioPET™ performs as compared to standard approved imaging products in assessing the function of heart muscle in coronary artery disease patients.

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The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent (BIOHELIX-II)

Clinicaltrials.gov (Mar 2013)

The purpose of this study is to the assess the clinical performance of the BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries.

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Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) Trial

Clinicaltrials.gov (Mar 2013)

This is prospective, randomized, multicenter, multinational, randomized (1:1) study. The aim of this study is to assess the importance of functional assessment of coronary artery disease prior to bypass surgery. In particular, an FFR-guided strategy will be compared to the traditional Angio-guided strategy in the guidance of surgical revascularization by aorto-coronary bypass grafting.

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Effects of oral chronic administration of ivabradine (7.5 mg bid) in comparison to placebo (bid) on top of beta-blockers, on central aortic blood pressure. Randomized, cross-over, double blind, multicentre, study over 10 weeks in patients with stable coronary artery disease, type II diabetes and a resting heart rate equal or superior to 70 bpm, already treated with beta-blockers.

Clinical Trials Register.eu (Mar 2013)

To evaluate the effect of ivabradine on central aortic systolic blood pressure (CASBP) in comparison to placebo in patients with stable CAD, type II diabetes, and a resting HR≥ 70 bpm, treated by beta-blockers.

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Cholesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant Patients (CHOLESS)

Clinicaltrials.gov (Mar 2013)

The primary objective of this study is to compare the efficacy and tolerability of ezetimibe vs. a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.

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Non-invasive and Invasive Assessment of Coronary Artery Disease (COMFORT)

Clinicaltrials.gov (Mar 2013)

The purpose of the study is to assess the diagnostic accuracy of a combined use of non-invasive coronary angiography with multi-slice computed tomography (MSCT) and stress cardiac magnetic resonance (CMR) imaging in patients with obstructive lesions on MSCT and with low to intermediate pre-test likelihood of coronary artery disease (CAD) as compared to invasive coronary angiography (CAG) and Fractional Flow Reserve (FFR) measurements.

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GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation

Clinicaltrials.gov (Feb 2013)

After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications.

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Mainz Registry of Flow-mediated Constriction

Clinicaltrials.gov (Feb 2013)

The goal of the flow-mediated constriction/ FMC-registry is to investigate whether the measurement of endothelial function using flow-mediated dilation and flow-mediated constriction provides on the presence of coronary atherosclerosis and on the prognosis of patients undergoing coronary angiography.

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Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System (DIRECT II)

Clinicaltrials.gov (Feb 2013)

The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting Stent in patients with single, never previously treated coronary artery lesions

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Validation of Myocardial Perfusion Imaging (CameraCZT)

Clinicaltrials.gov (Jan 2013)

The new cadmium-zinc-telluride (CZT) technology is a powerful tool for cardiac nuclear medicine. The increased photon counting sensitivity of camera can be used to explore novel protocols like dual isotope (rapid stress Tl-201/rest Tc-99m protocol for use with high-speed SPECT MPI). The use of dual isotope imaging is very interesting because this imaging combines the use of thallium-201 with technetium-99m agents permitting optimal image resolution and simultaneous assessment of viability, all with an exam duration of approximately 20 minutes. However, no study compares stress thallium-201/rest technetium-99m sequential dual isotope high-speed myocardial perfusion imaging versus invasive coronary angiography. The investigators report here the first validation of high-speed protocol with dual isotope for myocardial perfusion imaging using invasive coronary angiography as the standard of reference.

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Drug-Eluting Balloon in Stable and Unstable Angina (DEBUT)

Clinicaltrials.gov (Jan 2013)

The purpose of this study is to compare DEB with BMS in CAD patients who are at high risk of bleeding and in whom the use of DES is therefore avoided. Our hypothesis is that PCI with DEB is non-inferior to BMS in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients at high risk of bleeding.

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Standard Clopidogrel Versus Prasugrel Low Dose Therapy in Elderly Patients With Acute Coronary Syndrome (RESET ELDERLY)

Clinicaltrials.gov (Jan 2013)

The elderly represent a growing segment of the coronary population treated by dual antiplatelet therapy for percutaneous coronary intervention (PCI). These patients bear a higher risk of both ischemic events and bleeding complications than younger patients, with a subsequently higher rate of mortality.Recentprogress in antithrombotic treatment demonstrated the efficacy of adding a P2Y12 receptor antagonist to low-dose aspirin. Whether this benefit is also present in the elderly remains a debated issue due to the lack of specific data in this sub-population. The present study was realized to provide specific data on platelet response to clopidogrel, standard dose (75 mg) or prasugrel 5 mg in elderly patients (≥75 years old) whereas the superiority in PR response of the latter should allows the Prasugrel therapy in elderly patients with the better clinical efficacy and therapeutical safety already showed compared with Clopidogrel.

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The Prediction of Extent and Risk Profile of Coronary Atherosclerosis and Their Changes During Lipid-lowering Therapy Based on Non-invasive Techniques (PREDICT)

Clinicaltrials.gov (Jan 2013)

The prediction of extent and risk profile of coronary atherosclerosis based on clinical evaluation and non-invasive techniques. Detailed analysis of plaque volume, plaque composition, risk plaque features and shear stress (WSS) changes during lipid lowering therapy (rosuvastatin 40mg) from 3D vessel reconstruction. Prediction of changes in coronary arteries based on changes in non-invasive examinations. Examination of WSS influence on atherosclerosis development and changes of WSS during lipid lowering therapy.

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Study to Investigate the Effect of Heart Rate Reduction With Ivabradine on Vascular Elastic Properties and Endothelial Function in Patients With Stable Coronary Heart Disease

Clinicaltrials.gov (Jan 2013)

This study investigates whether chronic heart rate reduction with ivabradine (Procoralan®, Servier, France) affects aortic compliance and endothelial function in patients with chronic stable coronary artery disease.

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ARTDIVA Study : First in Man Safety Evaluation of the ART18Z Bioresorbable Stent

Clinicaltrials.gov (Jan 2013)

This prospective, multicentre, open labeled, single arm, first in man interventional investigation aims to evaluate the safety of the ART18Z bioresorbable stent for the treatment of patients with single de novo lesion of a native coronary artery with mandatory balloon predilatation.

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Safety of oral chronic administration of ivabradine modified release formulation compared to ivabradine immediate release formulation, in patients with stable coronary artery disease. A 6 to 12-month randomised double blind parallel groups multicentre study

Clinical Trials Register.eu (Aug 2012)

To compare the safety profiles of the ivabradine modified release (MR) formulation and ivabradine immediate release (IR) formulation over a 6-month period

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Effects of clopidogrel vs prasugel vs ticagrelor on endothelial function, inflammatory and oxidative stress parameters and platelet function in patients undergoing coronary artery stenting. A randomised, prospective study.

Clinical Trials Register.eu (Apr 2012)

The primary objective of the trial is to investigate the impact of the three treatments under study on endothelial function as assessed by flowmediated dilation (FMD) in patients who have undergone stenting.

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Effects of oral administration of ivabradine (7.5 mg bid) on post-ischaemic stunning induced by exercise stress in patients with coronary artery disease and exercise inducible ischaemia.

Clinical Trials Register.eu (Mar 2012)

To assess the effects of Ivabradine on post-ischaemic stunning induced by exercise stress in patients with stable coronary artery disease and exercise-inducible ischaemia

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Ranolazine on Major Adverse Cardiovascular Events in Subjects with a History of Chronic Angina Who Undergo Percutaneous Coronary Intervention with Incomplete Revascularization

Clinical Trials Register.eu (Dec 2011)

The primary objective of this study is to evaluate the efficacy of ranolazine as compared with placebo when used as part of standard medical therapy in chronic angina subjects with incomplete revascularization post-PCI on the composite of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization.

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Pneumococcal vaccination of Crohn patients - A randomized, non-blinded phase 4 clinical trial with the purpose of investigating the immune response against two different pneumococcal vaccines in patients with Crohn's disease

Clinical Trials Register.eu (Feb 2013)

To evaluate the impact of immunosuppressive drugs on the vaccination response in patients with Crohn's disease

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Antibiotics and Hydroxychloroquine in Crohn's

Clinicaltrials.gov (Jan 2013)

There is growing evidence that Crohn's disease may be caused by replication of bacteria, perhaps particularly E. coli, within macrophages (a specialized sort of white blood cell). Laboratory studies show that a combination of antibiotics that can penetrate macrophages (such as ciprofloxacin and doxycycline) together with the anti-malarial drug hydroxychloroquine (which makes the contents of macrophage vesicles more alkaline and helps them to kill intracellular bacteria) is particularly effective at killing the E. coli within macrophages.

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A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

Clinical Trials Register.eu (Jan 2013)

To evaluate the efficacy of MEDI2070 versus placebo to induce a clinical effect (defined as at least a 100-point reduction in Crohn’s Disease Activity Index [CDAI] from baseline) or remission at Week 8 in subjects with moderate to severe Crohn’s disease.

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A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease

Clinical Trials Register.eu (Jan 2013)

To compare the effect on disease activity of a single i.v. dose of NNC0114-0006 with placebo in subjects with moderately to severely active Crohn’s disease

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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease

Clinical Trials Register.eu (Sep 2012)

To evaluate the efficacy of AMG 181 as measured by the proportion of subjects achieving Crohn’s Disease Activity Index (CDAI) remission (CDAI < 150) at week 8

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Safe evaluation of obstructive crohns disease using bloodflow Time-intensity curves and Elastography correlated to Neutrocytes and collagen counts and biomechanical properties Obtained in Stenotic Intestine after Surgery (STENOSIS)

Clinical Trials Register.eu (Jul 2012)

To evaluate if intestinal wall perfusion, elasticity or peristaltics in patients with CD assessed with the modalities a) dynamic MRI, b) Contrast Enhanced UltraSound (CEUS) or c) Elastography UltraSound (EUS) are correlated to the degree of active or chronic disease and stiffness of tissue.

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Infliximab Top-down Study in Kids with Crohn’s disease

Clinical Trials Register.eu (Jul 2012)

The primary objective of our study is to determine the efficacy and safety of top-down IFX treatment in moderate-to-severe pediatric CD.

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A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12) + Pharmacogenetics Blood Sample Amendment 01 + UK-specific Amendment 04 (dated 23-Apr-12)

Clinical Trials Register.eu (Jun 2012)

The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn’s disease and who have had an insufficient response to conventional therapy or have failed anti-TNF therapy

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A randomized controlled trial investigating tailored treatment with infliximab for active luminal crohn's disease

Clinical Trials Register.eu (May 2012)

To investigate whether sustained trough levels of IFX can be achieved using IFX trough level measurements and adjustment of dosing based upon these levels by means of two different standardized algorythms in comparison with ‘standard of care’ IFX treatment and its effects on clinical and endoscopic outcomes

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A open-label extension study of CP-690,550 as maintenance therapy in patients with crohn’s disease

Clinical Trials Register.eu (Mar 2012)

The primary objective of the study is to assess the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with CD.

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Prospective pharmacodynamic study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets.

Clinical Trials Register.eu (Feb 2012)

To evaluate the effect of Rifaximin-EIR, administered at a daily dosage of 1,600 mg (2 x 400 mg tablet twice a day) for three months in patients with a moderately active Crohn's disease in terms of clinical response and correlation with endoscopic improvement to Rifaximin-EIR treatment.

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Phase II, open-label clinical trial to evaluate the safety and efficacy of platelet-rich plasma and fibrin clot processed with PRGF-System tecnology in the treatment of anal fistulas in Crohn's patients

Clinical Trials Register.eu (Feb 2012)

To evaluate the safety and feasibility of intralesional platelet-rich plasma and fibrin clot from autologous origin, processed with PRGF-System tecnology (BTI), for the treatment of perianal fistulas in Crohn's disease.

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A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease

Clinical Trials Register.eu (Dec 2011)

To induce clinical response (CDAI decrease from baseline ≥ 100 points) and/or remission (CDAI <150) following 12 weeks of treatment with one of two active doses of GSK1605786A for qualification of subjects for enrolment into a follow-on 52-week maintenance study (CCX114157).

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A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's Disease Revised Protocol 01 incorporating Protocol Amendment 02; Pharmacogenetics Blood Sample Amendment 01

Clinical Trials Register.eu (Dec 2011)

The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn’s Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn’s Disease

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A Pharmacokinetic Study Of The Combined Use Of Recombinant Human GH And IGF-1 In Children With Inflammatory Bowel (Crohn’s) Disease

Clinical Trials Register.eu (Jun 2011)

The objective of this study is to perform a short-term study to assess how well tolerated combined recombinant growth hormone therapy (rhGH) and insulin-like growth factor (rhIGF-1) therapy is compared to rhGh alone in children/adolescents with Crohn's disease. i.e. will it be acceptable to a child to give two injections in the morning? It is hoped that the results from this phase II study will provide the scientific and safety data to allow us to apply for regulatory permission to move on to a Phase III study of long term growth in children/adolescents whose growth is affected by their inflammatory bowel disease.

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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease

Clinical Trials Register.eu (Jun 2011)

The primary objectives are: - To evaluate clinical remission for the 2 SC maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn’s disease induced into clinical response with ustekinumab in the induction studies, CNTO1275CRD3001 and CNTO1275CRD3002. - To evaluate the safety of 2 SC maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn’s disease.

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A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease

Clinical Trials Register.eu (Jun 2011)

The primary objective: Part A / To evaluate the effect of TRK-170 on mucosal healing as measured by Crohn's Disease Endoscopic Index of Severity (CDEIS) score based on ileocolonoscopy and use this evaluation to decide which dose(s) of TRK-170 should be used in Part B Part B / To evaluate the efficacy of TRK-170 in patients with active CD as measured by CDAI score

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Correlation Between Haptoglobin Phenotypes and Infectious and Other Complications in Cystic Fibrosis Patients (Hp-in-CF)

Clinicaltrials.gov (Mar 2013)

Cystic Fibrosis is a genetic disease with variable severity, and a predisposition for lung infection. Usually severity is determined by the class of CF mutations, but even among patients with the same severity of mutations there is a variation of the severity of CF. Haptoglobin has several types (phenotypes), one of them was found to be related to infectious complications. In this study the investigators aim to find a correlation between Haptoglobin phenotypes in patients with CF and frequency of infectious complications. To this end the investigators will collect serum from CF patients, and determine their Haptoglobin protein phenotype. The investigators will correlate Haptoglobin phenotype to retrospectively gathered data on infectious complications.

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Bone Microarchitecture in Young Cystic Fibrosis Patients

Clinicaltrials.gov (Feb 2013)

The aim of this study is to evaluate bone microarchitecture of paediatric CF patients matched to sex-age-pubertal status-healthy volonteers. In the meantime, biological markers will be collected and DXA (Dual-energy x-ray absorptiometry) will be performed in order to explore potential correlations HR-pQCT parameters.

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Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic Fibrosis

Clinicaltrials.gov (Jan 2013)

Cystic Fibrosis (CF) is a congenital disease secondary to the abnormal function of CFTR. Patients with CF have an alteration of essential fatty acids, Arachidonic Acid (AA) is increased and Docosahexanoic Acid (DHA) is decrease and the ratio ω-6/ ω-3 is elevated, all these alterations stimulated a chronic and bad regulated state of inflammation. For this porpoise, a fase IV trial, multicentric, controlled, double blind, placebo and parallel in patients elder than two months old and randomized to received every day a dietetically supplement with DHA or placebo, will be done during 12 months. The trial has as a principal objective to proved if this long term supplementation could decrease in contrast with placebo.

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Ext. Long-term Safety Study in CF Patients: Single Arm TIP

Clinicaltrials.gov (Jan 2013)

The purpose of this extension study is to collect additional 48 weeks of safety data from patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting second year safety data through this study is to obtain long-term (2 years) safety data of TIP.

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Azole Therapy in Cystic Fibrosis (ATCF) : Efficacy of itraconazole and of voriconazole in patients with cystic fibrosis and presenting with persistent positive sputums for Aspergillus

Clinical Trials Register.eu (Aug 2012)

We wish to ascertain the effectiveness of the two possible treatments for Aspergillus infection in CF (voriconazole and itraconazole) and compare these to each other. Effectiveness will be assessed by the effect on growth of Aspergillus in the sputum, which we will also confirm with more sensitive techniques based on detecting Aspergillus DNA.

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A randomized placebo-controlled study to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and cystic fibrosis patients.

Clinical Trials Register.eu (May 2012)

To assess the safety and tolerability of single and and multiple doses of QBW251 in healthy subjects and cystic fibrosis patients To evaluate the pharmacodynamic response to multiple doses of QBW251 in cystic fibrosis patients as reflected in changes in lung function (forced expiratory volume in one second, FEV1 - Part4 only)

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis who Have the R117H-CFTR Mutation

Clinical Trials Register.eu (Apr 2012)

To evaluate the efficacy of ivacaftor in subjects with cystic fibrosis (CF) who have the R117H-CF transmembrane conductance regulator (CFTR) mutation

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A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-Term Ivacaftor Treatment in Subjects 6 Years of Age and Older with Cystic Fibrosis and a Non-G551D CFTR Mutation

Clinical Trials Register.eu (Apr 2012)

To evaluate the safety of long-term ivacaftor treatment in subjects with cystic fibrosis (CF)

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A Phase 2, multicenter, double-blinded, placebo-controlled, 3-part study to evaluate safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of VX 661 monotherapy and VX 661/VX 770 cotherapy in subjects with cystic fibrosis (CF), homozygous for the F508del-cystic fibrosis transmembrane conductance regulator gene (CFTR) mutation

Clinical Trials Register.eu (Apr 2012)

-To evaluate the safety and tolerability of VX 661 monotherapy and VX 661/VX 770 cotherapy -To evaluate the effect of VX 661 monotherapy and VX 661/VX 770 cotherapy on CFTR function

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Insulin therapy in non-diabetic adults with cystic fibrosis

Clinical Trials Register.eu (Feb 2012)

This study aims to investigate the effect of low dose insulin therapy on nutritional status en body weight.

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Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways

Clinical Trials Register.eu (Dec 2011)

The objective of this study is to evaluate safety of treatment with AZLI 75 mg 3 times daily (TID) for 3 courses of therapy (28 days on/28 days off) in female and male children less than 13 years of age with CF and chronic PA infection/colonization.

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Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients

Clinical Trials Register.eu (Dec 2011)

The primary objective is to find out, if continuous long-term local application of specific egg yolk antibodies (IgY) directed against PA - initiated after successfully treated acute PA infection - can prolong the time to recurrence of a sputum culture positive for PA. The objective to prevent infections with PA is also to diminish the need of antibiotics and minimize the problem of bacterial resistance against antibiotics.

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Exocrine Pancreatic Function Testing in Cystic Fibrosis

Clinicaltrials.gov (Oct 2011)

The purpose of this study is to develop and validate multimodal testing of exocrine pancreatic function. The investigators will be testing exocrine pancreatic function in patients with cystic fibrosis. Exocrine pancreatic function and imaging will be correlated to age group, genotype, nutritional status and quality of life. Earlier detection of exocrine pancreatic failure in the non classical form of CF may be of therapeutically benefit.

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Effect of Glycine in Cystic Fibrosis

Clinicaltrials.gov (Aug 2011)

The aim of this study is to evaluate if glycine, orally administered in a daily dose of 0.5 g/kg during 8 weeks, can ameliorate the airway inflammation in children with cystic fibrosis, as compared with placebo. During all of the study children will receive their usual treatment for cystic fibrosis.

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Costimulatory Molecules as Biomarkers in Cystic Fibrosis

Clinicaltrials.gov (May 2011)

The purpose of this study is to investigate the expression of a certain class of molecules, called costimulatory molecules, in humans with Cystic Fibrosis. Cystic Fibrosis is a genetic disorder which renders the lung susceptible to persistent inflammation which, at times, can worsen, resulting in accelerated decline in lung function and eventually death or transplant. Our goal is to determine if the levels of costimulatory markers can be used to predict exacerbation and subsequent lung function decline in subjects with Cystic Fibrosis.

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A Phase 2, Multicenter, Double Blinded, Placebo Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of VX-809 Alone and in Combination with VX-770 in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

Clinical Trials Register.eu (Oct 2010)

To evaluate the safety and tolerability when VX-809 is administered alone and when VX-809 is coadministered with VX-770. To evaluate the effect of VX-809 administered alone and VX-809 coadministered with VX-770 on sweat chloride.

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A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®

Clinical Trials Register.eu (May 2010)

To determine the long-term safety and efficacy of inhaled Nacystelyn®, in the presence or absence of rhDNase, in patients with CF as reflected in a change per treatment group in the time to first pulmonary exacerbation (PE) during the study period.

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An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis

Clinical Trials Register.eu (Apr 2010)

To evaluate the safety of long-term VX-770 treatment in subjects with cystic fibrosis (CF)

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Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients (DOXY)

Clinicaltrials.gov (Apr 2010)

The purpose of this study is to examine the role of a well-known and well-tolerated antibiotic, doxycycline, in the treatment of cystic fibrosis patients who are hospitalized. This antibiotic does not effectively treat the bacteria in airways of cystic fibrosis patients, but may reduce the activity of inflammatory molecules in the disease.

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A Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation

Clinical Trials Register.eu (Jul 2009)

Part A: To evaluate the pharmacokinetics of a single dose of orally administered VX 770 treatment in subjects 6 to 11 years of age with cystic fibrosis (CF) who have the G551D cystic fibrosis transmembrane conductance regulator (CFTR) mutation on at least 1 allele. Part B: To evaluate the efficacy of VX 770 after 24 weeks of treatment in subjects 6 to 11 years of age with CF who have the G551D CFTR mutation on at least 1 allele.

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation

Clinical Trials Register.eu (Jun 2009)

To evaluate the efficacy of VX 770 after 24 weeks of treatment in subjects with cystic fibrosis (CF) who have the G551D cystic fibrosis transmembrane conductance regulator (CFTR) mutation on at least 1 allele.

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Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study

Clinical Trials Register.eu (Mar 2009)

To determine whether inhaled mannitol compared to control improves FEV1 in patients with Cystic Fibrosis.

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Exercise-Induced Bronchospasm in Cystic Fibrosis

Clinicaltrials.gov (Dec 2008)

Exercise is an important clinical feature in cystic fibrosis. Better exercise capacity has been associated with better patient outcomes and quality of life. Exercise-induced bronchospasm is a condition, often associated with asthma, which may make exercise difficult. The role that exercise-induced bronchospasm has in people with cystic fibrosis is unknown. This study is designed to determine how often exercise-induced bronchospasm occurs in cystic fibrosis.

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A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.

Clinical Trials Register.eu (Jun 2008)

This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 μg q.d. and 5 μg q.d.) compared to placebo administered via the Respimat® device on lung function in patients with CF.

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Glutamine supplementation for cystic fibrosis: a parallel group randomized controlled trial

Clinical Trials Register.eu (May 2008)

To assess the impact of glutamine supplementation on markers of infection and lung function in patients with cystic fibrosis and previous pseudomonas infection

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Efficacy and safety of Intra-erythrocytes dexamethasone in cystic fibrosis

Clinical Trials Register.eu (Jul 2007)

The main objective is to determine the improvement or worsening lt; 2 of FEV1 in front of 18 months precedents the enrolnment.

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Peripheral targeting of inhaled rhDNase in stable CF patients.

Clinical Trials Register.eu (Apr 2007)

To investigate the effect of treatment with nebulized rhDNase targeted to the peripheral airways compared to rhDNase targeted to the central airways on FEF75 (a lung function parameter for peripheral airflow limitation) in children with CF who are on maintenance treatment with rhDNase.

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An open study on the pharmacokinetics and safety of oral voriconazole in adult patients with cystic fibrosis

Clinical Trials Register.eu (Mar 2007)

The primary endpoints of the trial are to determine the pharmacokinetic parameters for oral voriconazole and to determine if voriconazole serum levels >1.0mg L-1 are achieved in adult patients with cystic fibrosis using a standard oral dosing regimen.

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To investigate the effect of vitamin K supplementation on markers of bone turnover and bone density in adolescents and adults with cystic fibrosis

Clinical Trials Register.eu (Sep 2006)

To establish whether vitamin K supplementation in adolescent and adult patients with CF improves markers of bone formation.

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Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support

Clinicaltrials.gov (Mar 2013)

The purpose of this study is to investigate whether face-to-face Cognitive Behavioral Therapy (CBT) with a smartphone application, focused on providing support in homework assignments and an increase in behavioral activation, is effective in treating mild to moderate depression. The study will be conducted as a randomized controlled treatment study investigating the effect of the current blended treatment compared to treatment as usual.

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The Effect of Minocycline on Relapse After Successful Intravenous Ketamine/Minocycline-induced Symptoms Response in Subjects With Depression

Clinicaltrials.gov (Mar 2013)

The purpose of this study is to assess whether the antidepressant effect from intravenous (IV) ketamine treatment can be maintained by minocycline compared to placebo after IV ketamine treatment is stopped.

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Internetbased Relapse Prevention for Partially Remitted Depression (ISAK)

Clinicaltrials.gov (Mar 2013)

The main purpose of the study is to test whether Internet-based relapse prevention plus medication has a better protective effect compared to medication only, for persons with residual depressive symptoms who are currently in paid employment or in education.

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iCBT for Depression - Standard Versus Condensed Treatment Material (KONRAD)

Clinicaltrials.gov (Feb 2013)

In this study the investigators will assess reading speed and the ability to concentrate in all patients and then randomise them to an internet-based treatment for depression using either a standard material or a condensed one. The condensed material consists of 30000 words and will be available as text files and on audio files. The standard material consists of 60000 words and is only available as text files. Both groups will have the possibility of e-mail contact with a personal therapist during the treatment.

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Cytochrome P450-2D6 Screening Among Elderly Using Antidepressants (CYSCE)

Clinicaltrials.gov (Jan 2013)

Depression is common among elderly with an estimated prevalence of 5%. Due to ageing the national burden will double in the coming decade. Antidepressants as TCAs and SSRIs are effective in reducing symptoms, especially in people with severe depression. To optimize treatment efficacy and reduce side effects, the Pharmacogenetics Working Group of the Royal Dutch Pharmacists Association developed guidelines for dose-adaptation, for instance for antidepressants such as nortriptyline and venlafaxine based on their main relevant genotype (CYP2D6) accompanied by Therapeutic Drug Monitoring. Such personalized drug dosing based on pharmacogenetic information at the start of therapy can speed up the titration phase of antidepressants to establish an adequate maintenance dose. However, pharmacogenetic screening programs are expensive and evidence on effects and costs of such a program among elderly antidepressant starters from randomized controlled studies is lacking. The investigators will conduct a pragmatic randomized controlled trial to determine the effects and costs of pharmacogenetic screening information to optimize drug dosing in depressed elderly patients who start with nortriptyline or venlafaxine. Objective: The primary objective is to determine the effects of pharmacogenetic screening for CYP2D6 on the time to reach adequate blood levels as an accepted proxy for adequate treatment. Secondary objectives include adverse drug reactions and cost-effectiveness

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Deep Brain Stimulation of the Superolateral Branch of the Medial Forebrain Bundle (slMFB) for the Treatment of Refractory Major Depression (FORESEEII)

Clinicaltrials.gov (Jan 2013)

The investigators will investigate in a sham controlled staggered onset design antidepressant effects and safety of deep brain stimulation (DBS) to the superolateral branch of the main medial forebrain bundle (slMFB).

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Pharmacokinetics and safety of agomelatine in children (from 7 to less than 12 years) and adolescents (from 12 to less than 18 years) with Major Depressive Disorder. An open-labelled, multicenter, three-dose level, non-comparative study.

Clinical Trials Register.eu (Jan 2013)

The primary objective is to evaluate pharmacokinetics of 3 doses of agomelatine in patients from 7 to less than 18 years suffering from Major Depressive Disorder.

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Prevention of depression and poor physical function in older persons with vitamin D supplementation

Clinical Trials Register.eu (Jan 2013)

The primary objective of the D-Vitaal trial is to answer the following two questions: 1. Does vitamin D supplementation decrease depressive symptoms in older persons? 2. Does vitamin D supplementation improve physical performance and decrease functional limitations in older persons?

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Trial of Telephone-based Psychotherapy for Depression With and Without Adjunctive Supportive Mail (Tel-PT)

Clinicaltrials.gov (Jan 2013)

This study aims to compare the effectiveness of two telephone-based psychotherapy (Tel-PT) interventions for patients with mild to moderate depression. Both interventions consist of one personal session and weekly to bi-weekly 8-10 telephone sessions with a licensed cognitive-behavioral psychotherapist accompanied by the study of educational materials and the completion of regular monitoring questionnaires (total treatment duration: approximately 3 months). Patients are randomized into one of two conditions: Patients in the condition "Tel-PT including mail" additionally receive a motivating letter from their psychotherapist after each telephone session, while patients in the condition "Tel-PT without mail" receive no further interventions. Patients refusing to be randomized are to be assigned to the condition "Tel-PT without mail". This study takes place within a larger study evaluating a stepped care model for depression (01KQ1002B-TP7).

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The SPD489-322 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination with an Antidepressant in the Treatment of Adults with Major Depressive Disorder with Inadequate Response to Prospective Treatment with an Antidepressant

Clinical Trials Register.eu (Aug 2012)

The primary objective is to demonstrate the efficacy of SPD489 when used as augmentation therapy in the treatment of major depressive disorder (MDD) in inadequate responders following an 8-week course of treatment with an antidepressant, as measured by the mean change in Montgomery-?sberg Depression Rating Scale (MADRS) total scores.

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Ketamine augmentation of ECT to improve outcomes in depression

Clinical Trials Register.eu (May 2012)

Ketamine vs saline treatment will reduce ECT-induced cognitive impairments as measured by being able to learn new verbal information (anterograde verbal memory), remember personal events from their past (autobiographical memory) and saying the names of objects fluently (verbal fluency)

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A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Flexible Dose Study on the Efficacy of Lu AA21004 on Cognitive Dysfunction in Adult Subjects with Major Depressive Disorder (MDD)

Clinical Trials Register.eu (Apr 2012)

To evaluate the efficacy of treatment with flexible doses of Lu AA21004 (10 or 20 mg QD) versus placebo on cognitive dysfunction in patients with MDD.

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Interventional randomised, double-blind, parallel-group, placebo-controlled, exploratory study investigating the effects of Lu AA21004 on cognition and BOLD fMRI signals in subjects remitted from depression and controls

Clinical Trials Register.eu (Apr 2012)

• to determine whether Lu AA21004 compared to placebo in subjects remitted from depression modulates the blood oxygen level dependent (BOLD) signal in functional magnetic resonance imaging (fMRI) of the brain areas associated with executive function (working memory) during performance of the N-back task. The regions of interest are within the prefrontal cortex and anterior cingulate • to determine whether Lu AA21004 compared to placebo in subjects remitted from depression modulates the blood oxygen level dependent (BOLD) signal in functional magnetic resonance imaging (fMRI) of the brain areas associated with spatial memory during performance of the Arena task., The region of interest is hippocampus • to evaluate the effects of Lu AA21004 compared to placebo in subjects remitted from depression on the BOLD signal in fMRI in other brain regions involved in the regulation of cognitive processes during working memory and planning performance (N-back and Arena task)

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A Multicenter, Double-Blind, Placebo-Controlled Study of JNJ-40411813 as Adjunctive Treatment to an Antidepressant in Adults with Major Depressive Disorder with Anxiety Symptoms

Clinical Trials Register.eu (Apr 2012)

To evaluate the efficacy, as assessed by the change from baseline on a 6-item subscale derived from the Hamilton Anxiety Scale (HAM-A6), and overall safety and tolerability of treatment with adjunctive JNJ-40411813 compared to placebo in patients with MDD with anxiety symptoms being treated with an antidepressant.

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Ketamine in treatment resistant major depression (TRD)

Clinical Trials Register.eu (Mar 2012)

Effectiveness of a single i.v. application of the NMDA antagonist ketamine at subanaesthetic doses will be tested The study will extend prior reports of open label studies in exploratory sample sizes to a double blinded placebo controlled study on a larger sample of 40 patients.

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Effects of agomelatine versus escitalopram on emotional experiences in outpatients suffering from Major Depressive Disorder. An exploratory, randomised, double-blind, international, multicentre study with parallel groups: agomelatine (25 to 50 mg/day) versus escitalopram (10 to 20 mg/day) over a 6- month period.

Clinical Trials Register.eu (Mar 2012)

The purpose of this exploratory study is to differentiate the effect of two antidepressants, agomelatine versus escitalopram, on the emotional experiences in outpatients suffering from Major Depressive Disorder.

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A Double-Blind, Double-Randomization, Placebo-Controlled Study of the Efficacy of Intravenous Esketamine in Adult Subjects with Treatment-Resistant Depression

Clinical Trials Register.eu (Mar 2012)

The primary objective of the study is to evaluate the efficacy, safety, and tolerability of esketamine in subjects with treatment resistant depression. Efficacy in improving symptoms compared with a placebo will be assessed by the changes from randomisation to end of week 1 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.

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Effects of agomelatine (25 to 50 mg/day) on circadian rhythms in patients with Major Depressive Disorder. An exploratory 6-week open, flexible dose, international multicentre, non comparative study.

Clinical Trials Register.eu (Feb 2012)

Assess the effect of agomelatine on the circadian rhythms in Major Depressive Disorder patients by evaluating circadian parameters.

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A Phase IIa, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-6096 for Treatment Augmentation in Patients with Major Depressive Disorder.

Clinical Trials Register.eu (Jan 2012)

(1) To evaluate the efficacy of MK-6096 in comparison with placebo as treatment augmentation for patients with MDD, based on change from baseline to week 6 in MADRS total score. (2) To assess the safety and tolerability of MK-6096 as augmentation therapy for patients with MDD.

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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of RO4995819 Versus Placebo, as Adjunctive Therapy in Patients with Major Depressive Disorder Having Inadequate Response to Ongoing Antidepressant Treatment

Clinical Trials Register.eu (Jan 2012)

To evaluate the efficacy of 6 weeks treatment of RO4995819 versus placebo as adjunctive therapy in patients with MDD having inadequate response to ongoing antidepressant treatment based on mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline to end of treatment.

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A Double-blind, Placebo-controlled Study of Cariprazine (RGH-188) as Adjunctive Therapy In Major Depressive Disorder.

Clinical Trials Register.eu (Dec 2011)

The objectives of this study are to evaluate the efficacy, safety, and tolerability of cariprazine adjunctive to ADT in patients with major depressive disorder who have an inadequate response to ADT.

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A multicenter, Double-blind 58 week Rollover Study to assess the Safety and Tolerability of BMS-820836 in Patients with Treatment Resistant Major Depression.

Clinical Trials Register.eu (Oct 2011)

The purpose of this study is to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.

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A Preliminary Study of Intravenous Ketamine in Selective Serotonin Reuptake Inhibitor (SSRI)-Resistant Depression

Clinical Trials Register.eu (Aug 2011)

To evaluate if IV ketamine treatment given weekly over 3 weeks relieves depressive symptoms in patients who have not responded to SSRI (Selective Serotoninn Reuptake Inhibitors) Antidepressants.

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LY2216684 compared to Placebo as Adjunctive Therapy to SSRI in the Prevention of Symptom Re-emergence in Major Depressive Disorder

Clinical Trials Register.eu (Mar 2011)

The aim of the study is to assess the time to re-emergence of depressive symptoms

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Effect of Vildagliptin vs. Glibenclamide on Circulating Endothelial Progenitor Cell Number Type 2 Diabetes1

Clinicaltrials.gov (Mar 2013)

The purpose of this study is to evaluate the effect of DPP-IV inhibitor Vildagliptin vs. Glibenclamide on circulating endothelial progenitor cells (EPCs) number in type 2 diabetes patients in metformin failure. Subjects will be followed for 12 months after randomization.

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Effects of metformin on hepatic free fatty acid metabolism in type 2 diabetes asssessed by positron emission tomography

Clinical Trials Register.eu (Mar 2013)

It is the general purpose of the trial to investigate whether the positive effects of metformin on blood lipids are caused by improved glycemic control and changes in body composition or if they are caused by direct effects on lipid metabolism. We specifically plan to: - investigate hepatic fatty acid uptake, reesterification and oxidation assessed by positron emission tomography (PET) - investigate the effect of metformin on whole body VLDL-TG oxidation and redeposition in adipose tissue.

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GLP-1 Receptor Targeting in Diabetic and Healthy Individuals (GLP-1-CPOP)

Clinicaltrials.gov (Mar 2013)

The purpose of the study is to determine whether there are differences in pancreatic uptake of the radiotracer between healthy individuals and patients with type 1 diabetes. If T1D patients have a markedly reduced uptake, the compound may be suitable for estimation of pancreatic beta cell mass, i.e. the cells in the pancreas that produce insulin.

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A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily (BOOST®)

Clinicaltrials.gov (Mar 2013)

This trial is conducted globally. The aim of the trial is to compare efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c).

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Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management (AIRPEDIA)

Clinicaltrials.gov (Mar 2013)

The aim of the study is to assess the cost-effectiveness of telemedicine in the care of chronic diabetic foot ulcers.

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Acute Exercise and Pancreatic Endocrine Function

Clinicaltrials.gov (Mar 2013)

Subjects with type 2 diabetes will be stratified into two-quantiles based on ambient hyperglycemia (fasting glucose and HbA1c) and then the effects of a single aerobic exercise bout (1-hour at 50%VO2max) on pancreatic endocrine function will be determined.

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Twentyfour Ambulatory Pulse Wave Velocity and Central Augmentation Index in Type 2 Diabetes

Clinicaltrials.gov (Mar 2013)

The functionality and reproducibility of pulse wave analysis is investigated in 20 type 2 diabetic patients who had two 24 hour measurements performed within one week with the Arteriograph24 equipment.

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A Randomized, Multicenter Study to Evaluate Cardiovascular Outcomes with ITCA 650 in Patients Treated with Standard of Care for Type 2 Diabetes

Clinical Trials Register.eu (Feb 2013)

The primary objective of Study 107 is to obtain CV event data that will be pooled with CV event data from other pivotal Phase 3 studies in a meta-analysis to demonstrate that the upper limit of the 95% confidence interval of the hazard ratio of major adverse cardiac events (MACE) in adult patients on Standard of Care for T2D receiving either ITCA 650 or control, based on the time to first occurrence of any event in the MACE1 CV composite endpoint (CV death, non-fatal myocardial infarction [MI], non-fatal stroke, or hospitalization for unstable angina), does not exceed 1.8.

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A Comparison of LY2605541 versus Human Insulin NPH as Basal Insulin Treatment in Insulin-Naïve Patients with Type 2 Diabetes Mellitus not Adequately Controlled with 2 or more Oral Antihyperglycemic Medications: An Open-Label, Randomized Study.

Clinical Trials Register.eu (Feb 2013)

To demonstrate that LY2605541 (pooled before morning meal [AM] administration and at bedtime [PM] administration) is noninferior to human insulin NPH for change in hemoglobin A1c (HbA1c) from baseline to 26 weeks

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The Effects of RT-CGM on Glycemia and QoL in Patients With T1DM and IHA (IN CONTROL)

Clinicaltrials.gov (Feb 2013)

The purpose of this study is to determine what the effects are of real-time continuous glucose monitoring on glycemia and quality of life in patients with type 1 diabetes mellitus and impaired hypoglycemia awareness.

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A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Efficacy of the Addition of MK-3102 to Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

Clinical Trials Register.eu (Feb 2013)

After 24 weeks, to assess the effect of the addition of treatment with MK- 3102 compared to placebo on A1C. To assess the safety and tolerability of MK-3102.

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Closing the Loop in Children and Adolescents With Type 1 Diabetes in the Home Setting (APCam08)

Clinicaltrials.gov (Jan 2013)

Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring lifelong insulin therapy. Children and adolescents with T1D need regular insulin injections or the continuous insulin delivery using an insulin pump in order to keep blood glucose levels normal. We know that keeping blood sugars in the normal range will help prevent longterm diabetes-related complications involving the eyes, kidneys and heart. However, achieving treatment goals can be very difficult as the tighter we try to control blood glucose levels, the greater the risk to develop symptoms and signs of low glucose levels (hypoglycaemia). This is a particular problem at night and one solution is to develop a system whereby the amount of insulin injected is controlled by a computer and is very closely matched to the blood sugar levels on a continuous basis. This can be achieved by what is known as a "closed-loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives an insulin pump. We have been testing such a system in Cambridge over the last five years in children and have found that this system is effective at maintaining tight glucose control and preventing nocturnal hypoglycaemia. More recently the system has been tested in real life conditions in the home setting for three weeks during a pilot single-centre study. The next step is to extend the evaluation of closed-loop over a prolonged period of three months. In the present study we are planning to study 24 young people aged 6-18 years on insulin pump therapy. During three months glucose will be controlled by the computer and during the other three months the subjects will make their own adjustments to the insulin therapy. We aim to to determine the effect of the computer algorithm in keeping glucose levels between 3.9 and 8 mmol/L (normal levels) and reducing the time they spent with glucose below 3.9 mmol/L (hypoglycaemia). Participants' response to the use of the system in terms of lifestyle change, daily diabetes management and fear of hypoglycaemia will be assessed. We will also test for longer term glucose control by measuring glycated haemoglobin (HbA1c).

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Study of LY3016859 in Participants With Diabetic Nephropathy

Clinicaltrials.gov (Jan 2013)

The purpose of this two-part study is to investigate the safety, tolerability and efficacy of LY3016859 after multiple intravenous (IV) dosing's in participants with diabetic nephropathy (DN). Part A will be dose escalation for safety and tolerability and Part B will evaluate Proteinuria.

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Closed-loop Insulin Delivery in the General Ward (ANGIE02)

Clinicaltrials.gov (Jan 2013)

The main study objective is to compare conventional insulin therapy with automated closed-loop glucose control over 72 hours in achieving target glucose levels in hospitalised insulin-treated Type 2 diabetes (T2D) subjects. This is an open-label, two-arm, randomised, parallel design study in hospitalised insulin-treated T2D subjects, during which target glucose levels will be controlled either by closed-loop system combined with real-time continuous subcutaneous glucose monitoring (CGM) or by conventional insulin therapy.

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An open, single-centre, non-controlled feasibility study using a softwarealgorithm based insulin therapy to control blood glucose in type 1 diabetic patients

Clinical Trials Register.eu (Jan 2013)

To investigate the performance of a software-algorithm based insulin therapy to control blood glucose in Type 1 diabetic patients

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Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients. (Pascal)

Clinicaltrials.gov (Jan 2013)

The aim of this study is to show that PRPC performed in a single session using a Pascal laser leads to better management of the disease (better rate of regression of neovessels, lower risk of a loss of visual acuity in the long term related to macular edema), a saving of time and better comfort for both patient and doctor.

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A Phase III, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-3102 Versus Placebo in Subjects with Type 2 Diabetes Mellitus with Moderate or Severe Chronic Kidney Disease or Kidney Failure on Dialysis Who Have Inadequate Glycemic Control

Clinical Trials Register.eu (Jan 2013)

After 24 weeks, to assess the safety (incidence of adverse events) and tolerability (discontinuation rate) of MK-3102. After 54 weeks, to assess the safety (incidence of adverse events) and tolerability (discontinuation rate) of MK-3102.

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Protocol H9X-MC-GBDG A Randomized, Parallel-Arm, Double-Blinded Study Comparing the Effect of Once-Weekly Dulaglutide with Placebo in Patients with Type 2 Diabetes Mellitus on Sulfonylurea Therapy (AWARD-8: Assessment of Weekly AdministRation of LY2189265 in Diabetes – 8)

Clinical Trials Register.eu (Jan 2013)

The primary objective of this study is to demonstrate that once-weekly dulaglutide 1.5 mg is superior to placebo as measured by glycosylated hemoglobin A1c (HbA1c) at 24 weeks (change from baseline) in patients with type 2 diabetes mellitus on concomitant sulfonylurea therapy

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REVISE-Diabesity: Randomisation to Endoluminal intestinal liner alone Versus with Incretin analogue in SustainEd Diabesity

Clinical Trials Register.eu (Jan 2013)

In an NHS setting, what is the impact of Endobarrier (a device inserted into the intestine to coat its inside and prevent absorption of food where it is sited) alone versus combined Endobarrier-Liraglutide therapy (a daily injectable medication for type 2 diabetes) in patients with obesity and type 2 diabetes mellitus who have not yet met national treatment targets despite at least 6 months of Liraglutide treatment alone?

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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment with MK-3102 in Subjects with Type 2 Diabetes Mellitus

Clinical Trials Register.eu (Nov 2012)

To assess the impact of MK-3102 25 mg q.w. on time to confirmed CV outcomes across the MK-3102 program To assess the safety and tolerability of MK-3102 25 mg q.w.

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A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in Patients with Type 2 Diabetes

Clinical Trials Register.eu (Nov 2012)

Demonstrate that ITCA 650 is non-inferior to sitagliptin in reducing HbA1c in patients with type 2 diabetes following 52 weeks of treatment. The non-inferiority margin is 0.3%. If non-inferiority is demonstrated, then ITCA 650 will be tested for superiority in reducing HbA1c

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A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

Clinical Trials Register.eu (Oct 2012)

After 54 weeks, to assess the A1C-lowering efficacy of MK-3102 compared to glimepiride. To assess the safety and tolerability of MK-3102.

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Therapy with Dapagliflozin added to Saxagliptin in Combination with Metformin compared to Therapy with Placebo added to Saxagliptin in Combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and Saxagliptin Pharmacogenetics Blood Sample Amendment 01 - Site Specific, (V1.0, dated 22-June-2012)

Clinical Trials Register.eu (Oct 2012)

The purpose of this study is to learn if BMS-512148 (dapagliflozin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.

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A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy with Saxagliptin and Dapagliflozin added to Metformin compared to Add-On Therapy with Saxagliptin in combination with Metformin or Dapagliflozin in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone

Clinical Trials Register.eu (Oct 2012)

To compare the mean change from baseline in glycosylated hemoglobin (HbA1c) achieved with concurrent addition of saxagliptin and dapagliflozin to metformin versus the addition of placebo & saxagliptin to metformin & versus the addition of placebo plus dapagliflozin to metformin after 24 weeks of double-blind treatment.

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6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients with Type 2 Diabetes Mellitus not Adequately Controlled with Non-Insulin Antihyperglycemic Drugs with a 6-month Safety Extension Period

Clinical Trials Register.eu (Aug 2012)

To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6, week 26) in patients with type 2 diabetes mellitus.

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A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-875 25 mg and 50 mg Compared to Glimepiride When Used in Combination with Metformin in Subjects with Type 2 Diabetes

Clinical Trials Register.eu (Jul 2012)

To evaluate the efficacy of TAK-875 plus metformin compared to glimepiride plus metformin on glycemic control as assessed by change from baseline in HbA1c at Weeks 78 and 104.

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A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-875 25 mg and 50 mg Compared to Placebo and Sitagliptin 100 mg When Used in Combination with Metformin in Subjects with Type 2 Diabetes

Clinical Trials Register.eu (Jul 2012)

To evaluate the efficacy of TAK-875 plus metformin compared to placebo plus metformin and sitagliptin plus metformin on glycemic control as measured by change from baseline in HbA1c over a 24-week Treatment Period.

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects with Type 2 Diabetes and with Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events

Clinical Trials Register.eu (Jul 2012)

The primary objective is to demonstrate that no excess risk of CV composite events exists following treatment with TAK-875 compared with placebo when given in combination with Standard of Care in subjects with T2DM and clinically evident CV disease or multiple risk factors for CV events. For purposes of this study, the primary MACE composite comprises CV death, nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina (with or without revascularization).

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The effect of insulin degludec in combination with liraglutide and metformin in subjects with type 2 diabetes qualifying for treatment intensification

Clinical Trials Register.eu (Jul 2012)

To confirm the efficacy of IDeg compared to placebo, both in combination with liraglutide and metformin, in controlling glycaemia

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Treatment with Liraglutide in type 1 diabetic patients. Effects on glycemic control and counterregulation and cognitive performance during hypoglycaemia.

Clinical Trials Register.eu (Jul 2012)

Part 1: To investigate how long-term treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate. Part 2: To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide or placebo, respectively, affects counterregulatory hormones and cognitive performance during hypoglycemia.

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The influence of liraglutide on hypoglycaemia counterregulation and pulsatile insulin secretion in type 2 diabetics

Clinical Trials Register.eu (Jun 2012)

To establish, whether liraglutide improves the glucagon concentration under hypoglycaemic conditions in patients with type 2 diabetes

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A randomised, double blind, placebo controlled, parallel group efficacy and safety study of oral administration of empagliflozin twice daily versus once daily in two different daily doses over 16 weeks as add-on therapy to a twice daily dosing regimen of metformin in patients with type 2 diabetes mellitus and insufficient glycaemic control

Clinical Trials Register.eu (Jun 2012)

To investigate the efficacy and safety of different dosage regimens of empagliflozin, 5mg twice daily compared to 10 mg once daily versus placebo and 12.5 mg twice daily compared to 25 mg once daily versus placebo, administered orally as add-on therapy to metformin in patients with T2DM and insufficient glycaemic control

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Clinical proof-of-principle of the determination of the beta cell mass in vivo by SPECT imaging with the 111In-labeled GLP-1 analogue DTPA-[K40]-Exendin 4

Clinical Trials Register.eu (Jun 2012)

The primary objective is to proof that the pancreatic uptake of EX in patients with long-standing DM1 and non-measurable production of C-peptide, i.e. patients with no relevant beta-cell mass left, is clearly lower than in healthy individuals with intact glucose homeostasis and insulin production.

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Effects of Linagliptin on Renal Endothelium Function in Patients with Type 2 Diabetes.

Clinical Trials Register.eu (Jun 2012)

To determine the effect of linagliptin compared to placebo on basal production and release of nitric oxide (NO) from renal vasculature, as assessed by changes of renal plasma flow due to L-NMMA infusion.

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Efficacy and safety of liraglutide in combination with metformin versus metformin monotherapy on glycaemic control in children and adolescents with type 2 diabetes

Clinical Trials Register.eu (May 2012)

To confirm the superiority of liraglutide at the maximum tolerated dose (0.6 mg, 1.2 mg, 1.8 mg) in combination with metformin in controlling glycaemia versus metformin and liraglutide placebo in children and adolescent (ages 10–17 years) with type 2 diabetes.

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A single center, double-blind, placebo-controlled, randomized, crossover, phase II study to assess the effect of Aleglitazar on cardiac energetics and function in patients with uncomplicated type 2 diabetes mellitus and no history of coronary artery disease who are drug-naïve or treated with stable metformin monotherapy.

Clinical Trials Register.eu (May 2012)

To evaluate if aleglitazar improves cardiac energetics, by means of MRS, in uncomplicated T2D patients with no history of CAD, after 6 weeks of treatment

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The efficacy of insulin degludec/liraglutide as add-on therapy in controlling glycaemia in adults with type 2 diabetes inadequately controlled on sulphonylurea with or without metformin therapy

Clinical Trials Register.eu (May 2012)

To confirm superiority of insulin degludec/liraglutide compared to insulin degludec/liraglutide placebo in controlling glycaemia as add-on treatment in insulin naïve subjects with Type 2 Diabetes Mellitus (T2DM) inadequately controlled on sulphonylurea (SU) with or without metformin therapy after 26 weeks of treatment.

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A randomized open-label study to compare safety and efficacy of vildagliptin versus NPH insulin add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy

Clinical Trials Register.eu (Apr 2012)

1. To demonstrate that add-on to glimeperide vildagliptin is superior to NPH insulin with respect to the incidence of the combined endpoint, defined as a blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events (BG measurement < 3.9mM (71mg/dL)) and weight gain (+3%) in T2DM patients. 2. To demonstrate that add-on to glimepiride vildagliptin is superior to NPH insulin with respect to the rate of of confirmed hypoglycemic events (BG measurement < 3.9mM (71mg/dL)) in T2DM patients.

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A randomized, double-blind, placebo controlled trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of lixisenatide in paediatric (10 - 17 years old) and adult patients with type 2 diabetes

Clinical Trials Register.eu (Mar 2012)

To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric population (10-17 years old) and adults as controls

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A 24 week randomised, open label, 3 parallel-group comparison of once and twice daily biphasic insulin aspart (BIAsp) 30 plus sitagliptin and twice daily BIAsp 30, all in combination with metformin in insulin naïve type 2 diabetic subjects inadequately controlled on sitagliptin and metformin

Clinical Trials Register.eu (Mar 2012)

To compare the efficacy in terms of glycaemic control of biphasic insulin aspart 30 (BIAsp 30) twice daily + sitagliptin + metformin, BIAsp 30 twice daily + metformin and BIAsp 30 once daily + sitagliptin + metformin in subjects with type 2 diabetes inadequately controlled on sitagliptin and metformin (± other oral anti-diabetic drugs (OADs))

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Efficacy and safety of liraglutide versus placebo as add-on to existing diabetes medication in subjects with type 2 diabetes and moderate renal impairment

Clinical Trials Register.eu (Feb 2012)

To confirm the superiority of liraglutide versus placebo as add-on to existing oral antidiabetic drug (OAD) and/or insulin therapy on glycaemic control after 26 weeks treatment in subjects with type 2 diabetes and moderate renal impairment

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A 24-week, open-label, randomized, 2-arm parallel group, multinational, multi-center clinical trial to compare the efficacy and safety of lixisenatide injected prior to the main meal of the day versus lixisenatide injected prior to breakfast in type 2 diabetic patients not adequately controlled on metformin

Clinical Trials Register.eu (Jan 2012)

To compare the two treatment regimens in terms of change of HbA1c from baseline to endpoint (week 24)

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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 mg and 50 mg Compared with Placebo in Subjects with Type 2 Diabetes

Clinical Trials Register.eu (Jan 2012)

To evaluate the efficacy of TAK-875 compared with placebo on glycemic control as assessed by change from baseline in HbA1c over a 24-week Treatment Period.

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Adding liraglutide to the backbone therapy of biguanide in patients with coronary artery disease and newly diagnosed type-2 diabetes

Clinical Trials Register.eu (Jan 2012)

The main objective of the trial is to investigate whether glucagon-like peptide-1 (GLP-1) analogue combined with metformin therapy compared to metformin monotherapy a) improves betacell function b) improves left ventricular ejection fraction (LVEF) during stress test in newly diagnosed type-2 diabetes mellitus (T2D) patients, who exhibit stable coronary artery disease (CAD)

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A phase IIa study to characterize the effects of CCL2 inhibition with the Spiegelmer® NOX-E36 in patients with type 2 diabetes mellitus and albuminuria.

Clinical Trials Register.eu (Dec 2011)

To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio (ACR) in patients with type 2 diabetes and albuminuria

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A Phase III, Multicenter, Double-Blind, Randomized, Placebo- and Metformin-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Sitagliptin in Pediatric Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control

Clinical Trials Register.eu (Oct 2011)

In pediatric patients (ages 10-17 years) with T2DM with inadequate glycemic control: (1) after 16 weeks, to assess the effect of treatment with sitagliptin compared with placebo on A1C (2) to assess the safety and tolerability of sitagliptin

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6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both plus Mealtime Insulin in Patients with Type 2 Diabetes Mellitus with a 6-month Safety Extension Period

Clinical Trials Register.eu (Aug 2011)

Change in HbA1c from baseline to endpoint (scheduled month 6)

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Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)

Clinicaltrials.gov (Oct 2010)

The main objective of the study is to follow prospectively a cohort of patients with pre-diabetes to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in this population.

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A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control

Clinical Trials Register.eu (Oct 2010)

After 12 weeks, to assess the effect of treatment with MK-3102 compared with placebo on A1C.

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Prospective Study on Diabetes Mellitus and Its Complications in Newly Diagnosed Adult Patients (GDC)

Clinicaltrials.gov (Jan 2010)

The aim of the prospective observational GDC-Study in patients with newly diagnosed diabetes mellitus aged 18-69 years at inclusion into the study is to characterize in detail the clinical, metabolical and immunological phenotype and monitor the progression of the disease.

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Effects of EXEnatide on Glycemic Control and Weight over 26 weeks in Continuous Subcutaneous Insulin Infusion (CSII) Treated Patients with Type 2 Diabetes: a phase 2/3 doUble blind randoMized Placebo-controlled trial.

Clinical Trials Register.eu (Jan 2010)

Change from baseline to 6 months of centrally measured HbA1c

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Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"

Clinicaltrials.gov (Dec 2009)

The study will determine whether the anti-CD3 monoclonal antibody, teplizumab, can help to prevent or delay the onset of type 1 diabetes (T1D) in relatives determined to be at very high risk for developing the disease. Teplizumab has been studied in new onset type 1 diabetes for testing of efficacy and safety in previous studies; other studies are currently in progress. The results of previous studies indicate that teplizumab reduces the loss of insulin production during the first year after diagnosis in individuals with type 1 diabetes. The purpose of this study is to determine if teplizumab can interdict the immune process that causes the destruction of insulin secreting beta cells in the pancreas during the "pre-diabetic" state and thereby prevent or delay the onset of type 1 diabetes.

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The effect of sitagliptin on postprandial lipoprotein metabolism in patients with diabetes mellitus type 2

Clinical Trials Register.eu (Sep 2009)

The main objective of the study is to evaluate whether treatment with sitagliptin (100 mg/d) for 10 weeks will result in an improvement of postprandial lipoprotein metabolism compared to glimepiride (1 mg/d) despite similar HbA1c reduction in drug naive type 2 diabetic patients.

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A Phase III, randomised, double-blind, placebo-controlled parallel group efficacy and safety study of linagliptin 5 mg administered orally once daily over 24 weeks in type 2 diabetic patients with insufficient glycaemic control despite a therapy of metformin in combination with pioglitazone

Clinical Trials Register.eu (Sep 2009)

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.

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A randomized, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week double-blind treatment period assessing the efficacy and safety of lixisenatide in patients with Type 2 diabetes insufficiently controlled with insulin glargine and metformin

Clinical Trials Register.eu (Aug 2009)

The primary objective of this study is to assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to insulin glargine and metformin in terms of HbA1c change over a period of 24 weeks.

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A phase III randomised, double-blind parallel group extension study to investigate the safety and efficacy of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46

Clinical Trials Register.eu (May 2009)

The objective of the current study is to investigate the safety and efficacy of linagliptin 2.5 mg plus metformin either 500 mg or 1000 mg, twice daily in comparison to metformin 1000 mg monotherapy twice daily given for 54 weeks.

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A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination with Metformin in Subjects with Type 2 Diabetes

Clinical Trials Register.eu (May 2009)

To evaluate the durability (for up to approximately 2 years) of the efficacy of alogliptin plus metformin as compared to glipizide plus metformin as measured by HbA1c change from baseline to Week 52 or 104 in adults with type 2 diabetes mellitus.

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A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week main treatment period and an extension assessing the efficacy and safety of AVE0010 on top of pioglitazone in patients with type 2 diabetes not adequately controlled with pioglitazone.

Clinical Trials Register.eu (Aug 2008)

The primary objective of this study is to assess the efficacy of AVE0010 on glycemic control in comparison to placebo as an add-on treatment to pioglitazone in Type 2 Diabetes patients treated with pioglitazone in terms of absolute HbA1c reduction over a period of 24 weeks.

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of 12-Week Administration Of Pf-00734200 To Subjects With Type 2 Diabetes Mellitus And Insufficient Glycemic Control On Metformin Treatment

Clinical Trials Register.eu (Feb 2008)

To evaluate the effect of two oral doses of PF-00734200 on change from baseline to 12 weeks in HbA1c levels in subjects with T2DM on metformin.

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A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of Sitagliptin Compared With Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control

Clinical Trials Register.eu (Feb 2008)

To assess the HbA1c-lowering efficacy of sitagliptin compared to metformin after 24 weeks of treatment. To assess the safety and tolerability of sitagliptin over 24 weeks of treatment.

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Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial

Clinical Trials Register.eu (Jan 2008)

To determine whether intervention with Angiotensin Converting Enzyme Inhibitors (ACEI), Statins, or a combination of both, when compared with placebo, will reduce urinary albumin excretion, decline in renal function and the risk for diabetic nephropathy (DN) and cardiovascular disease (CVD)

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A randomized, double-blind, placebo-controlled, parallel-group study to determine whether, in patients with type 2 diabetes at high risk for cardiovascular and renal events, aliskiren, on top of conventional treatment, reduces cardiovascular and renal morbidity and mortality.

Clinical Trials Register.eu (Sep 2007)

The primary objective of this study is to determine whether aliskiren, when added to conventional treatment, compared to placebo, delays the occurrence of cardiovascular and /or renal complications in patients with type 2 diabetes at high risk for cardiovascular and renal events.

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Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes

Clinicaltrials.gov (Jul 2007)

The aim of this study is to determine if early and tight restoration of metabolic control at the onset of Type 1 diabetes (T1DM) will improve insulin secretion (C-peptide production) versus routine diabetes management.

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The effect of Pioglitazone on vascular and ventricular function in people with type 2 diabetes PICCOLA

Clinical Trials Register.eu (May 2007)

This study aims to use a novel, sensitive, non-invasive scanning technique to investigate the effects of insulin-sensitizing agent pioglitazone, on heart and artery function.

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The Effect of a Diabetes Action Team in Patients Post Infrainguinal Bypass Surgery With and Without Diabetes

Clinicaltrials.gov (Apr 2007)

Diabetes is a very common illness. Approximately 4% of British Columbians have diabetes. However, at least 20% of people admitted to acute care hospitals have diabetes. People with diabetes are at a higher risk for developing complications after surgery including infection and prolonged hospital stay, especially if blood sugars are high. The researchers are testing a Diabetes Action Team to see if their involvement in patient care after surgery improves blood glucose control, duration of stay in hospital, and infection rates.

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Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus

Clinicaltrials.gov (Jan 2007)

The Type 1 Diabetes TrialNet study group will further explore the potential role of oral insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also include a secondary group of individuals at different levels of risk than those in the primary cohort to gather information for future studies.

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A 52-week multicenter, open-label, randomized, parallel, two - arm study comparing Exubera® (inhaled human insulin) vs. Humalog® (insulin lispro), both in combination with insulin glargine in subjects with type 1 diabetes mellitus - protocol A2171035.

Clinical Trials Register.eu (Nov 2006)

The primary objective of the study is to demonstrate non-inferiority of an insulin regimen using insulin glargine as the basal insulin with Exubera as the mealtime insulin, compared to a regimen using insulin glargine as the basal insulin and insulin lispro as the mealtime insulin in terms of glycemic control (HbA1c) after 52 weeks of treatment with each treatment regimen.

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Normalization of dyrk1A and APP Function as an Approach to Improve Cognitive Performance and Decelerate AD Progression in DS Subjects: Epigallocatechin Gallate as Therapeutic Tool

Clinicaltrials.gov (Sep 2012)

Epigallocatechin-3-gallate (EGCG), the major catechin in green tea, is postulated to modulate dual specificity tyrosine-phosphorylation-regulated kinase 1A (DYRK1A) and amyloid beta precursor protein (APP) gene overexpression in the brains of Down syndrome mouse models. The clinical study is aimed at demonstrating that normalization of Dyrk1A and APP functions is a therapeutic approach to improve cognitive performance and decelerate AD (Alzheimer's disease) like progression.

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A Molecular and Functional Brain Imaging Study in Individuals With Down Syndrome and Healthy Controls Following Single Dose RG1662

Clinicaltrials.gov (Aug 2012)

This single-center, double-blind, placebo-controlled, parallel-group study with crossover component will evaluate the GABAAalpha5 receptor expression, occupancy and functional connectivity in the brains of individuals with Down syndrome and healthy controls following single dose RG1662. On two separate visits, no less than 96 hours and no more than 6 weeks apart, subjects will receive a single oral dose of either RG1662 or placebo followed by positron emission tomography (PET) and magnetic resonance imaging (MRI) scans.

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A Non-Drug Study of The Suitability of Neurocognitive Tests And Functioning Scales For The Measurement of Cognitive And Functioning Changes in Individuals With Down Syndrome

Clinicaltrials.gov (Mar 2012)

This non-drug, longitudinal, multi-center, multi-national study will evaluate the suitability of neurocognitive tests and functioning scales for the measurement of cognitive and functioning changes in individuals with Down Syndrome. Tests will be administered at clinic visits in Weeks 1, (4) and 24. The duration of the study for each individual will be between 24 and 27 weeks.

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Towards Onset Prevention of COGnitive decline in adults with Down syndrome (the TOP-COG study)

Clinical Trials Register.eu (Aug 2011)

The aims of the study are to gather the data needed to design a full-scale multi-centred RCT of oral simvastatin 40mg a day.

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Genetically determined brain abnormalities in Down’s Syndrome.- towards a treatment: A randomised, single-blind, placebo-controlled trial of lithium carbonate in Down’s Syndrome (DownsLit).

Clinical Trials Register.eu (Jul 2009)

Our primary objective is to determine if brain myo-inositol concentration is significantly reduced in non-demented DS individuals by brief 4 week treatment with lithium carbonate at normal therapeutic doses with full monitoring of potential side effects in all participants.

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An open-label study of two single oral doses of galantamine, examining the pharmacokinetics, safety, and tolerability in children with Down syndrome

Clinical Trials Register.eu (Dec 2006)

To determine the pharmacokinetic characteristics of glantamine after 2 single oral doses in children with Down syndrome.

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Cortical Excitability Changes Induced by Retigabine: a Transcranial Magnetic Stimulation Study (CERETI)

Clinicaltrials.gov (Mar 2013)

The objective of this study is to characterize the effects of a single-dose of retigabine on cortical excitability in healthy subjects, as quantified by means of TMS.

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Neurodevelopmental Outcome of Early Dietary Lysine Restriction in Pyridoxine Dependent Epilepsy Patients (NOEL)

Clinicaltrials.gov (Feb 2013)

Restricting dietary lysine intake in infants from age 3 months or less with confirmed diagnosis of pyridoxine-dependent epilepsy due to Antiquitin (ATQ) deficiency will: reduce the accumulation of neurotoxic substratesα-aminoadipicsemialdehydeandits cyclic equivalent 1-piperideine-6-carboxylate;and will improve overall neurodevelopmental outcome at 3 years of age by acting as an effective intervention into the complex pathophysiology of the condition.

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Study of [11C]DPA-713 for Temporal Lobe Epilepsy

Clinicaltrials.gov (Feb 2013)

Some people with epilepsy have an epileptic focus, a small part of the brain that is the starting point of the seizure. This focus is like an irritant or an inflammation, and helps cause the seizure. People with epilepsy that affects the temporal lobe of the brain often have an epileptic focus. Researchers want to look at the epileptic focus by using a drug that attaches to a protein associated with inflammation. An imaging study with the drug will show how much inflammation is in the area of the brain where the seizures start. The drug, called [11C]DPA-713, will be tested for its effectiveness in people with temporal lobe epilepsy. Its effects will be compared with imaging studies given to healthy volunteers. The aim is to see if [11C]DPA-713 can show the inflammation in the epileptic focus of seizures.

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Biomarkers In Seizure To Predict Recurrence and Severe Outcomes (BISTRO)

Clinicaltrials.gov (Jan 2013)

We study the hypothesis that combination of Proteine S100 beta and Copeptin within normal ranges can rule out seizure recurrences and severe outcome, and allow early discharge from the emergency department

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A Controlled Clinical Trial of Cathodal Transcranial Direct Current Stimulation in Patients With Refractory Epilepsy

Clinicaltrials.gov (Jan 2013)

There is a continuous necessity for the search of new alternatives for safe, affordable and effective noninvasive therapies for patients that are not eligible for focal resective or palliative surgery. The transcranial direct current stimulation (tDCS) therapy has demonstrated to be safe, noninvasive, simple and effective with promising results in case series, case reports and animals models for the treatment of intractable epilepsy. tDCS is a feasible and low cost method to modify cortical excitability in a non-invasive procedure. Its effects on cortical excitability seem to be similar to the effects induced by repetitive transcranial magnetic stimulation. The aim of this study is determine the safety and efficacy in the reduction of the number of seizures (>50%) and epileptiform activity in patients with refractory and multifocal epilepsy after different protocols of tDCS compared with placebo.

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Contribution of High Resolution EEG Functional Connectivity Measures to Presurgical Evaluation of Patients With Intractable Epilepsy (conneXion)

Clinicaltrials.gov (Nov 2012)

Electroencephalography (EEG) with very high spatial resolution (HR-EEG, 256 electrodes) allow for better analysis of local and global activity of the cerebral cortex, as compared with conventional EEG. Since January 2012, the Neurology Department of CHU Rennes is the first clinical service in France equipped with such a system. Applied to HR-EEG recordings, brain connectivity methods are likely to provide essential information (in the form of "connectivity graphs") on cortical networks, either dysfunctional or not, involved in the generation of interictal paroxysms (like spikes or spike-waves) and during seizures. So far, many methods have been proposed (see for a review: Wendling et al., 2009; Wendling et al., 2010). However, since each method is highly sensitive to the type of model that is assumed for the underlying relationship between distinct brain regions (Ansari-Asl et al., 2006), none of them has yet demonstrated its effectiveness.

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Multimodal Imaging in Pre-surgical Evaluation of Epilepsy (EPIMAGE)

Clinicaltrials.gov (Oct 2012)

Epilepsy is the most common chronic neurological disorder in the world, affecting more than 50 million people worldwide. Approximately 35% of patients with epilepsy are refractory to all available antiepileptic drugs. Drug-resistant epilepsies are often partial or focal. Patients with drug-resistant focal epilepsy suffer from an increased risk of death, primarily due to seizure-related fatalities, in comparison with the general population. The only therapeutic option for this form of epilepsy is the surgical removal of the region of the brain responsible for seizures, called the epileptogenic zone (EZ). This requires the precise localization of the EZ based on a comprehensive pre-surgical evaluation of patients. Today the gold standard for localizing the EZ and validating a non-invasive technique for localization of the EZ remains intracerebral stereo-EEG (stereo-electroencephalography or SEEG) recordings of spontaneous seizures. The implementation strategy of the intracerebral depth electrodes is guided by clinical and neuroimaging data, including anatomical Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) with FDG (fluoro-Deoxy-Glucose) and MagnetoEncephaloGraphy (MEG). Although the contribution of each technique in the pre-surgical localization of the EZ has already been shown, no wide-scale study has examined the cumulative contribution of these three techniques.

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Effect of Brivaracetam (BRV) on Nonpsychotic Behavioral Side Effects in Subjects Treated Previously With Levetiracetam (LEV)

Clinicaltrials.gov (Jul 2012)

Trial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such side effects; as well as the efficacy, safety and tolerability of BRV. No statistical hypothesis testing will be performed.

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An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects with Seizure Clusters

Clinical Trials Register.eu (Jun 2012)

To evaluate the long-term safety and tolerability of USL-261 in the treatment of seizure clusters using the following: • Occurrence of respiratory depression after study drug administration (defined as < 8 breaths per minute and/or a sustained decrease in respiratory effort requiring emergency rescue treatment with assisted breathing or intubation). • AEs • Clinical laboratory measurements. • OAA/S Sum Score and Composite Scores at the end of the seizure cluster (within 6 hours after study drug administration). • Physical, nasal, and neurological examinations. • Vital sign measurements. • C-SSRS • Requirement for ER or EMS visits.

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A pragmatic randomised controlled trial comparing the effectiveness and cost effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: a comparison of Standard And New Antiepileptic Drugs (SANAD-II)

Clinical Trials Register.eu (May 2012)

Arm A - To compare the clinical and cost-effectiveness of initiating monotherapy with lamotrigine, levetiracetam or zonisamide in patients with untreated focal onset seizures. Arm B - To compare the clinical and cost-effectiveness of initiating monotherapy with levetiracetam or valproate in patients with untreated generalised onset seizures or untreated seizures that are difficult to classify.

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An Open-Label, Multicenter, Single-Arm Study to Evaluate the Reduction in Nonpsychotic Behavioral Side Effects in Subjects with Epilepsy Switching from Levetiracetam to Brivaracetam due to Nonpsychotic Behavioral Side Effects

Clinical Trials Register.eu (Apr 2012)

To evaluate the reduction of nonpsychotic behavioral side effects in subjects with epilepsy who switched to BRV 200mg/day after discontinuing LEV 1g/day to 3g/day due to these nonpsychotic behavioral side effects

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Medication Adherence in Individuals With Epilepsy

Clinicaltrials.gov (Mar 2012)

The specific aims of the proposed research are: - To test the hypothesis that there will be a main effect of information, motivation and behavioral skills, on adherence behavior, and that a mediation model will show that information and motivation effects are partially mediated through behavioral skills. - To identify self regulation strategies and their situational cues (good opportunities, facilitators, and barriers) for medication adherence among individuals with epilepsy to better describe best practices and challenges.

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Serum Profile of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy: New Targets for Diagnosis and Prediction of Drug Resistance

Clinicaltrials.gov (Mar 2012)

Epilepsy affects 0.7% of the general population and 15-20% of patients develop drug resistance. The temporal lobe epilepsy (TLE) is the most common symptomatic focal epilepsies with a particularly high rate of drug (about 20 to 30%). In this type of epilepsy, where feasible, surgical removal of the home is the best therapeutic outcome. Mechanisms of epileptogenesis and drug resistance are still mysterious. Of recent clinical and experimental studies have shown that dysfunction of the blood-brain barrier (BBB) contributes to epileptogenesis and drug resistance. It is now recognized that cytokines exacerbate the excitability and permeability of the BBB, which was recently confirmed by studies showing that treatment of inflammation reduces epileptogenesis. Moreover, we have described an association between pathological angiogenesis and BBB permeability in the tissue of patients with excision of drug-resistant TLE. With experimental models, it was revealed an activation of the VEGF-VEGFR2 by seizures leading to rapid degradation of the BBB. The investigators hypothesis is that the identification of factors involved in BBB permeability may designate potential targets for drug-resistant partial epilepsy.

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An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects with Seizure Clusters

Clinical Trials Register.eu (Mar 2012)

To evaluate the long-term safety and tolerability of USL-261 in the treatment of seizure clusters using the following: - Occurrence of respiratory depression after study drug administration (defined as < 8 breaths per minute and/or a sustained decrease in respiratory effort requiring emergency rescue treatment with assisted breathing or intubation). - AEs - Clinical laboratory measurements. - OAA/S Sum Score and Composite Scores at the end of the seizure cluster (within 6 hours after study drug administration). - Physical, nasal, and neurological examinations. - Vital sign measurements. - C-SSRS - Requirement for ER or EMS visits.

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A Phase 2b, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Ranging Study to Evaluate the Efficacy and Safety of VX-765 in Subjects With Treatment Resistant Partial Epilepsy With a 24-Week Open-Label Extension

Clinical Trials Register.eu (Feb 2012)

To evaluate the efficacy, safety, and tolerability of VX-765 to treat seizures in subjects with treatment resistant partial epilepsy

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Buspirone Therapy for Localized Epilepsy

Clinicaltrials.gov (Dec 2011)

The obective of this study is to test whether buspirone can reduce the frequency of seizures in people whose seizures seem to start from one part of the brain.

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A prospective, multinational, open-label, single-arm, explorative study to evaluate the tolerability and efficacy of Lacosamide when added to Levetiracetam with withdrawal of the concomitant sodium channel blocking antiepileptic drug in subjects with uncontrolled partial-onset seizures

Clinical Trials Register.eu (Dec 2011)

The primary objective of this study is to assess the overall effectiveness of LCM (optimized within the range of 200mg/day to 600mg/day) when added to a stable dose of LEV (in the label range of 1000mg/day to 3000mg/day) with withdrawal of the concomitant SCB-AED in subjects with partial-onset seizures not adequately controlled on their dual LEV and SCB-AED regimen.

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Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy

National Cancer Institute (Dec 2011)

The purpose of this study is to investigate the correlation of SV2A expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with their clinical response to levetiracetam.

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Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy (EFA)

Clinicaltrials.gov (Oct 2011)

This study is carried through as a randomized controlled trial which investigates the effect of participation in a 10-week cardio exercise program in people with Juvenile Myoclonic Epilepsy aged 15-50.

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Epidemiologic Follow Up Study of Newly Diagnosed Epilepsy Among Seniors

Clinicaltrials.gov (May 2011)

The purpose of this proposed research is to identify individuals in southeastern Arizona aged 65 years and older who have new onset seizures (or newly diagnosed epilepsy) and monitor them for at least two years. In doing so the investigators will be able to describe the public health burden of this condition and to identify factors that predict clinical outcomes and health care needs in this population, using quantitative, administrative, and qualitative data. The aims of this proposed research are 1) to determine the two-year incidence of newly diagnosed epilepsy in the target population, 2) describe health care resource utilization of the target population using Medicare data, 3) validate the use of Medicare beneficiary data to estimate incidence of epilepsy, and 4) describe the burden of this condition in different ethnic groups.

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Double-Blind, Randomized, Historical Control Study of the Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects with Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs

Clinical Trials Register.eu (Feb 2011)

To evaluate the efficacy of eslicarbazepine acetate monotherapy at a dose of 1600 mg/day in subjects with partial epilepsy not well controlled by current antiepileptic drugs (AED), in comparison to a historical pseudo-placebo control group in accordance with the White Paper on Alternative Monotherapy Design in the Treatment of Epilepsy.

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A multi-center, open-label, single-arm study to evaluate hormone and lipid levels in male subjects with partial onset seizures after a switch of treatment from carbamazepine as adjunctive treatment to levetiracetam to lacosamide as adjunctive treatment to levetiracetam.

Clinical Trials Register.eu (Feb 2011)

The objective of this study is to evaluate the change in hormonal parameters and lipid parameters in serum after switching from Carbamazepine treatment to Lacosamide treatment as adjunctive therapy to Levetiracetam.

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Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD)

Clinicaltrials.gov (Dec 2010)

This is a three-center prospective case-control study to examine the patterns of fertility among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy (WWoE).

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A Multicenter, Double Blind, Double Dummy, Randomized, Positive Controlled Study Comparing The Efficacy And Safety Of Lacosamide (200 To 600mg/Day) To Controlled Release Carbamazepine (400 To 1200mg/Day), Used As Monotherapy In Subjects (≥16 Years) Newly Or Recently Diagnosed With Epilepsy And Experiencing Partial Onset Or Generalized Tonic Clonic Seizures

Clinical Trials Register.eu (Sep 2010)

The objective of this study is to compare the efficacy and safety of Lacosamide (LCM) (200 to 600mg/day) to Carbamazepine Controlled release CBZ CR (400 to 1200mg/day) used as monotherapy for at least 1 year, efficacy being measured as a primary endpoint by 6 month seizure freedom, in newly or recently diagnosed epilepsy subjects. The study will employ a noninferiority design to show at least a similar benefit risk balance for LCM compared with CBZ CR, using 6-month seizure freedom as primary endpoint.

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Effects Of Eslicarbazepine Acetate (Bia 2-093) On Cognitive Function In Children With Partial Onset Seizures: An Add-On, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Multicentre Clinical Trial

Clinical Trials Register.eu (Jun 2010)

The primary study objective is to evaluate the effects of ESL on cognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures (double blind 12 weeks)

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Epilepsy Birth Control Registry (EBCR)

Clinicaltrials.gov (Mar 2010)

Despite the importance of birth control to women of reproductive age, there has been little formal investigation of the safety and effectiveness of birth control methods in women with epilepsy. To remedy this, doctors from Harvard and Columbia University Medical Schools have developed a website that offers a survey to help us gain more knowledge and some educational material that will be updated regularly to provide the latest information. The ultimate goal is to develop guidelines for the selection of safe and effective birth control methods and to make sure that the best forms of birth control become available to women with epilepsy in all communities of our society.

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A Multi-Center, Open-Label Study To Evaluate The Tolerability, Safety And Efficacy Of Lacosamide (200 Mg - 400mg/Day) As Add-On Therapy For Patients With Partial Onset Epilepsy Using A Flexible Dose-Escalation Schedule And Individualized Maintenance Doses

Clinical Trials Register.eu (Mar 2010)

The objective is to evaluate if a flexible dose escalation, up to 400mg/day (maximum recommended dose), or to a lower dose, clinically effective for an individual patient, improves lacosamide (Vimpat) tolerability.

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Prospective Randomized 12-Week Controlled Study Of Visual Field Change In Subjects With Partial Seizures Receiving Pregabalin Or Placebo

Clinical Trials Register.eu (Oct 2009)

To evaluate visual fields in subjects with partial epilepsy receiving 12 weeks treatment of pregabalin compared to placebo.

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A superiority, randomized, open-label, multi-center study to compare the efficacy and safety of adjunctive zonisamide vs replacement with zonisamide of the last added antiepileptic drug in patients with partial onset seizures.

Clinical Trials Register.eu (Apr 2009)

The primary objective of this study is to assess, in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy, the safety and efficacy of the triple therapy vs the double therapy.

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A randomised, double blind, placebo-controlled study to evaluate the safety, tolerability and explore the efficacy of zonisamide as add-on therapy in elderly patients with refractory partial seizures.

Clinical Trials Register.eu (Oct 2008)

To compare the effect of add-on treatment with zonisamide to that of placebo on cognition and sedation in an elderly population with refractory partial seizures.

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An open-label, multinational, multicenter, follow-up study to evaluate the long-term safety and efficacy of brivaracetam, used at a flexible dose up to a maximum of 200 mg/day, in subjects aged 16 years or older suffering from epilepsy.

Clinical Trials Register.eu (Jun 2008)

To evaluate the long-term safety and tolerability of brivaracetam at individualized doses with a maximum of 200 mg/day in subjects suffering from epilepsy.

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A Non-Randomized, Within Subject Placebo-Controlled Exploratory Study of the Effects of JNJ-26489112 on the Photic Induced Paroxysmal EEG Response in Subjects with Photosensitive Epilepsy

Clinical Trials Register.eu (Sep 2007)

To determine oral doses of JNJ-26489112 that result in complete suppression or reduction of IPS induced photoparoxysmal-EEG response, a marker of antiepileptic activity. To assess the safety, tolerability, pharmacokinetics and pharmacokinetic/pharmacodynamic relationship of JNJ-26489112 in subjects with photosensitive epilepsy.

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A double-blind, randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of adjunctive zonisamide in paediatric partial onset seizures

Clinical Trials Register.eu (Sep 2007)

To assess the efficacy of zonisamide in paediatric epilepsy subjects with partial onset seizures treated with one or two other AEDs.

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A Prospective Study to Determine the Adverse Drug Reactions Profile of Anticonvulsants in Children

Clinical Trials Register.eu (Jul 2007)

To prospectively determine the nature and rate of adverse drug reactions, or side effects, in children on anticonvulsants.

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Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)

Clinicaltrials.gov (Mar 2013)

To study the safety and efficacy of the combination of LJM716 and BYL719 against currently available treatments of physician's choice in previously treated esophageal squamous cell carcinoma patients.

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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG 102) with Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

Clinical Trials Register.eu (Feb 2013)

To determine if the treatment of rilotumumab in combination with ECX significantly improves overall survival (OS) as compared with rilotumumab-placebo in combination with ECX in subjects with unresectable locally advanced or metastatic MET-positive gastric or GEJ adenocarcinoma.

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Definitive Radiochemotherapy Plus/Minus Cetuximab in Unresectable Locally Advanced Esophageal Cancer

Clinicaltrials.gov (Feb 2013)

Esophageal cancer is a highly aggressive tumor. Treatment options are various and range from chemotherapy to radiotherapy and several surgical techniques. Nevertheless, the overall survival rates for this disease remain poor. During the last years the combination of cetuximab with standard chemotherapy or radiotherapy has mainly be investigated in clinical trials focusing on colorectal and/or head and neck cancer. The results obtained from theses studies were very encouraging and led to the initiation of active clinical research in esophageal cancer patients with antibody inhibition of the EGFR. The first data in this indication are encouraging showing that cetuximab can safely be added to chemoradiation for esophageal cancer patients with first hints of efficacy. Based on the experiences with cetuximab in colorectal cancer and in combination with radiotherapy in head and neck cancer, the aim of the present study is to evaluate the feasibility of a combined treatment of cetuximab with continuous infusional 5-FU, cisplatin and radiotherapy in patients with esophageal cancer and to assess if the overall survival rates can be increased by addition of an EGFR-targeted therapy.

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Comparison Study of Brachytherapy and Endoscopic Stenting for Dysphagia in Esophago-Gastric Junction Cancer (BRASTEGAC)

Clinicaltrials.gov (Feb 2013)

The objective of the study is comparison of the efficacy and safety of palliative therapy with single-dose brachytherapy or selfexpanding metal stents (SEMS) in malignant dysphagia resulting from adenocarcinoma of the esophago-gastric junction.

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Phase II clinical trial of a sequential therapy involving the FLOT regiment in palliative first-line treatment followed by AIO plus irinotecan in second-line treatment combined with supportive parenteral nutrition and physical activity in patients with advanced non-resectable adenocarcinoma of the stomach and the gastro-oesophageal junction - impact on quality of life and fatigue: FLOTIRI - gastric cancer trial

Clinical Trials Register.eu (Jan 2013)

To assess the median survival

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NY-ESO-1 T Cells in OG Cancer (NY-ESO-1 OG)

Clinicaltrials.gov (Jan 2013)

This is a trial of adoptive T cell therapy using the patient's own T cells, genetically engineered to target the tumour associated antigen NY-ESO-1 (New York esophageal squamous cell carcinoma 1). Eligible patients will undergo leukapheresis (a process to remove white blood cells) to retrieve sufficient T cells which will be gene modified and expanded in the laboratory. Patients will undergo preconditioning chemotherapy with cyclophosphamide (60mg/kg) day -7 and day -6, followed by fludarabine (25mg/m2) day -5 to day -1. The NY-ESO-1 gene modified cells will be re-infused on day 0 and the patients will receive up to 14 doses of intravenous Interleukin2 (100000 U/kg) from day 0 to day 4. The primary objective of response rate according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria will be assessed by CT scans carried out at week 6, week 12 and at 12 weekly intervals thereafter.

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Effects of Chemotherapy on Muscle Mass and Exercise Performance in Patients With Oesophageal Cancer. (Oeso-Chemo)

Clinicaltrials.gov (Dec 2012)

Curative treatment for oesophageal cancer involves undertaking chemotherapy followed by an operation to remove the tumour. Chemotherapy has several effects upon the body, including effects upon the systems that control the creation and breakdown of muscle. We aim to review these effects by recording changes in the amount of exercise patients are able to undertake after chemotherapy and reviewing changes in muscle mass.

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Barrett's Intervention for Dysplasia by Endoscopy (BRIDE)

Clinicaltrials.gov (Nov 2012)

This feasibility study is a vital step towards two trials: (a) a trial to compare the two non-surgical techniques and (b) a trial comparing surgery with endoscopic treatment. It will help us find out whether it will be possible to enroll and retain enough patients by using several centres, and to identify/resolve any other potential barriers to recruitment and retention, including exploring viewpoints of patients and surgeons.

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A randomized Phase II multicenter, Open Label Study Evaluating the Efficacy and Safety of IMAB362 in Combination with the EOX (Epirubicin, Oxaliplatin, Capecitabine) regimen (plus Zoledronic acid/Interleukin-2) as First-Line Treatment of Patients with CLDN18.2-positive advanced Adenocarcinomas of the Stomach, the esophagus or the gastroesophageal junction. (FAST)

Clinical Trials Register.eu (Sep 2012)

• Progression-free survival (PFS) • Safety and tolerability of IMAB362 in combination with EOX and in case arm 3 is activated with ZA and IL-2

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Cisplatin and 5-FU +/- Panitumumab for Patients With Nonresectable,Advanced or Metastatic Esophageal Squamous Cell Cancer (POWER)

Clinicaltrials.gov (Jun 2012)

The primary objective is to demonstrate superiority of 5-FU, Cisplatin and Panitumumab over 5-FU and Cisplatin alone in terms of overall survival in esophageal cancer.

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A randomized, open-label, two-arm phase II trial comparing the efficacy of sequential ipilimumab versus best supportive care following first-line chemotherapy in subjects with unresectable locally advanced/metastatic gastric or gastro-esophageal junction cancer. Protocol Amendment 01-Pharmacogenetics Blood Sample Amendment (dated 12-Jan-2012), site specific, and administrative letter 01dated 07-Feb-2012 Protocol Amendment 02: Biomarker substudy (dated 12-Jan-2012), site specific

Clinical Trials Register.eu (May 2012)

The purpose of the study is to compare the efficacy of ipilimumab and standard of care immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.

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Study to Evaluate the Efficacy of Pravastatin on Survival and Recurrence of Advanced Gastroesophageal Cancer

National Cancer Institute (Dec 2011)

The survival of esophageal cancer and stomach cancer (EGC) at 5 years is less than 30%. Pravastatin is a potent inhibitor of HMG-CoA reductase inhibitor that has shown increased survival in patients with advanced hepatocellular carcinoma. The objective is to evaluate the efficacy of treatment (increase in survival and recurrence-free period of the disease) with pravastatin in patients with advanced EGC.

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Influence of N-Acetylcysteine on Morbidity, Oxygenation and Cytokine Levels in Partial or Total Esophagectomy for Cancer

National Cancer Institute (Dec 2011)

The purpose of this study is to evaluate the effect of high-dose n-acetylcysteine on inflammatory reaction, pulmonary morbidity, oxygenation and quality of life in patients undergoing transthoracic, partial or total resection of the esophagus for cancer.

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Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment Trial

National Cancer Institute (Dec 2011)

The purpose of this study is to compare the results of preoperative chemotherapy and radiation followed by surgery to surgery followed by postoperative chemotherapy and radiation for esophageal cancer.

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A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma

National Cancer Institute (Dec 2011)

This multicentered clinical trial is going to find out the radio-sensitization action of sodium glycididazole in radiochemotherapy for esophageal cancer.

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An open-label, randomized phase III trial of cisplatin and 5-fluorouracil with or without panitumumab for patients with nonresectable, advanced or metastatic esophageal squamous cell cancer

National Cancer Institute (Dec 2011)

To demonstrate superiority of 5-fluorouracil, cisplatin and panitumumab over 5-fluorouracil and cisplatin alone in terms of overall survival in esophageal cancer

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A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE)

Clinical Trials Register.eu (Aug 2011)

To assess the relative efficacy of AZD4547 compared with paclitaxel by comparison of the change in tumour size at 8 weeks in all randomised patients and also in the patients with tumours that have FGFR2 amplification (FISH score 6) alone.

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Explorative trial to investigate catumaxomab (anti-EpCAM x anti-CD3) for treatment of peritoneal carcinomatosis in patients with gastric adenocarcinomas prior to gastrectomy

Clinical Trials Register.eu (Feb 2011)

The main objective of this trial is to investigate the efficacy of catumaxomab by determination of the rate of macroscopic complete remissions of peritoneal carcinomatosis after treatment with one cycle (four doses) of catumaxomab followed by six cycles of fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) chemotherapy. The primary endpoint is the rate of macroscopic complete remissions of peritoneal carcinomatosis at the second diagnostic laparoscopy or laparotomy.

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Dose determination of Taxotere®, Eloxatin® and Xeloda® (TEX) in combination with Herpectin® as first line treatment to patients with HER2-positive non-resectable esophagus, cardia or gastric cancer

Clinical Trials Register.eu (Dec 2010)

To determine maximum tolerable dose (MTD) for the combination regime TEX (docetaxel, oxaliplatin and capecitabine) + trastuzumab and to evaluate the toxicity

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Multimodal therapy with and without cetuximab in patients with locally advanced esophageal carcinoma. An open-label phase III trial

Clinical Trials Register.eu (Apr 2010)

Determine the efficacy of neoadjuvant radiochemotherapy (RCT) combined with immunotherapy followed by adjuvant immunotherapy compared with the same schedule without immunotherapy (neoadjuvant and adjuvant).

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A randomised phase II study of radio-chemotherapy with or without panitumumab (Vectibix®) in irresectable squamous cell carcinoma or adenocarcinoma of the oesophagus (Panoramic)

Clinical Trials Register.eu (Apr 2010)

Description of the 1-year overall survival after chemo-radiation therapy with or without panitumumab in irresectable carcinoma of the oesophagus. The control arm is used to validate whether the historical cohort used for comparison is similar to our success-rate

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Genetic and Environmental Risk Factors Related to Esophageal Cancer

Clinicaltrials.gov (Dec 2009)

This clinical trial is studying genetic and environmental risk factors related to esophageal cancer.

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Oesophageal squamous cell cancer: chemoradiotherapy versus chemotherapy and surgery - a feasibility study

Clinical Trials Register.eu (Oct 2009)

The principal research question is to determine whether a randomised controlled trial comparing induction chemotherapy followed by oesophagectomy and induction chemotherapy followed by definitive chemoradiotherapy for oesophageal squamous cell carcinoma is feasible in terms of recruiting and randomising sufficient numbers.

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Double-blind, placebo-controlled, randomized phase II-study investigating the efficacy of Bevacizumab for symptom control in patients with malignant ascites due to advanced-stage gastrointestinal cancers

Clinical Trials Register.eu (Sep 2009)

To evaluate the paracentesis-free survival (ParFS) following intraperitoneal application of Bevacizumab/Placebo

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Chemoradiation combined with panitumumab followed by surgery for patients with operable esophageal cancer

Clinical Trials Register.eu (Dec 2008)

A consistent finding in many studies in patients with operable esophageal and gastro-esophageal junction (GEJ) cancer is that response to preoperative therapy, particularly the absence of residual disease in the surgical specimen, is an indicator of better disease-free and overall survival. Therefore in our trial we will evaluate the pathologic response of panitumumab in combination with neoadjuvant chemoradiation as first line treatment of operable adenocarcinomas, undifferentiated or squamous cell carcinomas of the esophagus.

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Cancer Oesophagus Gefitinib(COG) - Phase III randomised, double-blind, placebo-controlled trial of gefitinib (Iressa®) versus placebo in oesophageal cancer progressing after chemotherapy.

Clinical Trials Register.eu (Oct 2008)

To assess whether gefitinib will improve overall survival in patients with oesophageal cancer when compared to a placebo.

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Activity of sunitinib in esophageal cancer, melanoma and sarcoma

Clinical Trials Register.eu (Apr 2008)

Evaluate the objective respons rate as defined by the RECIST method for patients with advanced esophageal cancer, melanoma and sarcoma.

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Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer

Clinicaltrials.gov (Apr 2008)

This randomized phase III trial is comparing how well giving paclitaxel and cisplatin together with radiation therapy works with or without cetuximab in treating patients with locally advanced esophageal cancer.

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A randomised open-labelled multicentre trial of the efficacy of epirubicin, oxaliplatin and capecitabine (EOX) with or without panitumumab in previously untreated advanced oesophago-gastric cancer (REAL3)

Clinical Trials Register.eu (Feb 2008)

To determine whether adding panitumumab to standard chemotherapy with epirubicin, oxaliplatin and capecitabine (EOX), improves the median overall survival of patients with advanced oesophago-gastric cancer.

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COUGAR-02: A randomised phase III study of docetaxel vs active symptom control in patients with relapsed oesophago-gastric adenocarcinoma

Clinical Trials Register.eu (Nov 2007)

To assess whether chemotherapy with docetaxel improves survival in patients with advanced gastric cancer previously treated with platinum/fluoropyrimidine or raltitrexed therapy.

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p53-Adjusted Neoadjuvant Chemotherapy for potentially resectable Oesophageal Cancer "pANCHO".

Clinical Trials Register.eu (May 2007)

The objective of this prospective randomized predictive marker study is to evaluate the interaction between a predictive marker and response to induction chemotherapy in patients with potentially resectable esophageal cancer. This study is designed to demonstrate the significant interaction of the two p53 genotypes (mutant versus normal) and response to 2 different neoadjuvant chemotherapies.

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A randomised phase II/III multi-centre clinical trial of definitive chemo-radiation, with or without cetuximab, in carcinoma of the oesophagus

Clinical Trials Register.eu (Feb 2007)

To determine whether the addition of cetuximab to definitive chemo-radiation (CRT) results in increased survivial, and is safe and feasible to use in the treatment of patients with non-metastatic carcinoma of the oesophagus.

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Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer

Clinicaltrials.gov (Nov 2006)

The purpose of this study is to see whether or not the combination of cisplatin, irinotecan and radiation, followed by surgery, followed by oral Sutent, is effective and safe for patients with resectable esophageal cancer.

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A phase I/II study of Docetaxel (Taxotere, TM), Cisplatinum and Capecitabine (Xeloda, TM) (TCX) in patients with advanced oesophago-gastric cancer.

Clinical Trials Register.eu (Jul 2006)

The phase I objective is to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of a chemotherapy regime called 'TCX' (Taxotere,TM, cisplatinum and Xeloda,TM) when it is given every 3 weeks in patients with advanced oesophagogastric cancer. The phase II objective is to determine the efficacy of the regime based on response rate using RECIST criteria and to confirm a recommended dose.

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Risk of Falls in Fibromyalgia (FM)

Clinicaltrials.gov (Mar 2013)

Fibromyalgia is a chronic illness characterized by persistent widespread muscle pain with generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms: fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. The prevalence has been reported to be between 2 and 5%. The hypothesis of this study is that women with fibromyalgia present high risk of falls and balance disorders compared with healthy women. The objective of this study was to investigate wether gait pattern changes in single and dual task conditions were associated with the risk of falling in women with fibromyalgia.

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Neurodynamic Intervention in Fibromyalgia (FM)

Clinicaltrials.gov (Mar 2013)

Fibromyalgia is a chronic illness characterised by persistent,widespread muscle pain with generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. This condition is very prevalent. It has been reported to be about 2-5% of the general global population. Fibromyalgia have been reported to have neurodynamic disorders. The purpose of this prospective study was to examine the combined effects of soft tissue mobilization and nerve slider neurodynamic technique on pain and pressure sensitivity in women with fibromyalgia.

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Randomized, placebo-controlled and double blind clinical trial to assess the efficacy of ubidecarenone in patients diagnosed with fibromyalgia

Clinical Trials Register.eu (Oct 2012)

To compare the efficacy of coenzyme Q10 versus placebo in patients diagnosed with fibromyalgia in terms of clinical response measured by means of the Fibromyalgia Impact Questionnaire (FIQ)

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Cupping in Fibromyalgia (CuFib)

Clinicaltrials.gov (Jul 2012)

The purpose of this randomized controlled study is to determine the effectiveness of cupping in patients with fibromyalgia compared to sham cupping.

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Efficacy Study of Relaxation to 12 Weeks Against Placebo in the Overall Care Chronic Pain in Patients With Fibromyalgia (Sophrodol-1)

Clinicaltrials.gov (Jun 2012)

The main objective of this protocol is to measure the improvement of the overall situation of patients with diffuse chronic pain or fibromyalgia to 12 weeks by non-drug treatment relaxation. Secondarily,is to evaluate the evolution of physical variables, psychological and social improvement of the quality of life. To evaluate the evolution of drug consumption

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Evaluation of the efficacy of memantine in the treatment of fibromyalgia: a double-blind randomized control clinical trial.

Clinical Trials Register.eu (Apr 2012)

To evaluate the efficacy of memantine in the treatment of pain

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Efficacy of memantine in the treatment of fibromyalgia: an open, uncontrolled, exploratory 3-months follow-up study

Clinical Trials Register.eu (Nov 2011)

Evaluate the efficacy of memantine in the reduction of glutamate brain levels in patients with fibromialgia

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A 15 week, randomized, double blind, parallel-group, placebo-controlled, flexible-dose, safety and efficacy study of pregabalin in adolescents (12-16 years old) with fibromyalgia

Clinical Trials Register.eu (Jun 2010)

To evaluate the safety and efficacy of pregabalin (75-450 mg/day) compared with placebo in an adolescent fibromyalgia population.

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Efficacy and safety of Eslicarbazepine acetate as therapy in patients with fibromyalgia: a double blind, randomised, placebo controlled, parallel group, multicentre clinical trial

Clinical Trials Register.eu (Mar 2009)

The primary objective of this study is to assess the efficacy of Eslicarbazepine Acetate as therapy in patients with fibromyalgia syndrome (FMS).

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Pharmacokinetic-pharmacodynamic modeling of S(+)-ketamine in fibromyalgia

Clinical Trials Register.eu (Jun 2008)

The main objectives of this study are : pain reduction of fibromyalgia related pain and improvement of quality of life

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A Long-Term, Open-Label Safety and Efficacy Study of Xyrem (sodium oxybate) in Subjects with Fibromyalgia

Clinical Trials Register.eu (Aug 2007)

The primary objective of this study is to assess the safety of Xyrem (sodium oxybate) in long term use (up to 38 weeks) in subjects completing a double-blind controlled trial of Xyrem for the treatment of fibromyalgia.

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A multicenter, multiple dose, double-blind, randomized, placebo-controlled, parallel group study of the safety and efficacy of AGN 203818 in female patients with fibromyalgia syndrome.

Clinical Trials Register.eu (Mar 2007)

To evaluate the safety and efficacy of AGN 203818 oral capsules administered twice-daily as compared with placebo in female patients with fibromyalgia syndrome.

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A european phase III, multicentre, double-blind, randomised, monotherapy, 12-month study of Milnacipran for the treatment of the Fibromyalgia Syndrome

Clinical Trials Register.eu (Oct 2006)

To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100, 150 and 200 mg daily.

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Mortality Following Surgery for Proximal Femoral Fractures (HipMo)

Clinicaltrials.gov (Mar 2013)

Proximal femoral fractures are most frequent traumatologic and orthopedic diagnoses undergoing surgery. It affect most seniors and accompanied by a series of complications. The aim of our retrospective clinical trial is to establish a thirty-day mortality rate after surgical solutions, mortality during hospitalization and compare the types of anesthesia chosen during the performance (general vs. subarachnoid anesthesia).

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Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures (1-2-KiWI)

Clinicaltrials.gov (Mar 2013)

Metacarpal V fractures are injuries of the upper extremities. They occur frequent