Clinical Trials

The Pharmacokinetics of MK-7145 Following Single Dose Administration in Participants With Moderate Renal Insufficiency (MK-7145-018)

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.

A Retrospective Observational Study on the Use of Biologics in Monotherapy in Patients With Rheumatoid Arthritis

This retrospective, observational, multi-center study will evaluate the use of biological agents (e.g. RoActemra/Actemra [tocilizumab]) in monotherapy in patients with rheumatoid arthritis. Data from medical record files will be collected of patients currently treated with a biologic in monotherapy.

A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in Subjects With Rheumatoid Arthritis

This study is designed to evaluate the long-term safety and tolerability of VX-509 in subjects with active rheumatoid arthritis (RA) on DMARD therapy. This study will enroll subjects who completed a previous designated study with VX-509 (e.g., Study VX12-509-103).

Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis

The aim of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG0974 in subjects with mild to moderate Ulcerative Colitis

Non-invasive Diagnostics of Pulmonary Hypertension With Dual Energy Computed Tomography

The aim of the study is to determine relevant hemodynamic parameters for the diagnostics of pulmonary arterial hypertension (PAH) by dynamic contrast enhanced dual-energy CT (DE-CT). In this prospective study the investigators validate DE-CT results of patients against hemodynamic parameters from right heart catheterisation and control the results by other clinical investigations. The investigators expect that using this non-invasive method, parameters relevant for the diagnosis of the patients with PAH, like pulmonary blood volume, blood flow and perfusion heterogeneity, can be determined.

Multi-Center Randomized Clinical Trial Irreversible Electroporation for the Ablation of Localized Prostate Cancer

Multi-centre Randomized Clinical Trial: 200 patients with confirmed unilateral high-volume low risk (Gleason score 3 + 3) or intermediate risk prostate cancer (Gleason score 3 + 4) will undergo an IRE treatment. These patients will be randomized into one of the two groups of the study. Group 1: Hemi-ablation of the prostate at the side of the positive biopsies (hemi-ablation) Group 2: Total ablation of the prostate (total ablation) Patients will have an ultrasound of the prostate and the imaging data will be entered into the Planning Software system of the IRE-device. The volume of the prostate is measured and a specified ablation zone will be determined. The patients will be admitted for overnight stay in the hospital on the morning of the scheduled IRE procedure. The IRE will be performed under general anaesthetic and the specified zone identified in the planning stage will be ablated. Two to four IRE electrode needles will be placed into the prostate under ultrasound image guidance with a perineal approach using a brachytherapy grid. When the needles are in place, electric pulses of one to two minutes duration are used to ablate the specified zone. The total procedure time will be approximately 1 hour. Safety data will be collected and patients will be followed up at 1 day post-operatively, 1 month, 3 months, 6 months and 1, 2 and 3 year(s) post IRE.

Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy

This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy.

CardioPET as PET Imaging Agent to Assess Myocardial Perfusion and Fatty Acid Uptake in Known or Suspected CAD Subjects

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.

A Multicenter Phase II Pilot Open Label (BKM120)

Due to the high frequency of activation of PI3K and downstream effectors in progressive, recurrent and poorly differentiated cancers, inhibition of the PI3K signaling pathway with BKM120, a potent pan class I PI3K inhibitor, represents a particularly relevant therapeutic target and should be properly evaluated in advanced follicular and poorly differentiated thyroid carcinomas

Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy (CONKO-007)

This randomized trial examines the effectiveness of chemoradiotherapy compared to chemotherapy alone after induction chemotherapy with 3 cycles of gemcitabine or 6 cycles of FOLFIRINOX in patients with locally advanced, non resectable and non-metastatic pancreatic cancer. Chemotherapeutic agent in chemoradiotherapy is gemcitabine administered in 5 cycles, the agent and its administration for sole chemotherapy is determined by induction chemotherapy. Operability of tumor is evaluated four weeks after end of treatment. Patients will be followed for the duration of therapy and for 5 years after the last study treatment. Overall survival at the end of follow up is defined as primary endpoint. Secondary endpoints are tumor-free survival, rate of local recurrence or local progression, rate of distant metastasis, acute and late toxicity of the chemoradiotherapy, quality of life, rate of remission, rate of curative resections (R0) after chemotherapy and chemoradiotherapy. It is planned to include a total number of 830 patients.

A Multicenter Phase II Pilot Open Label (BKM120)

Due to the high frequency of activation of PI3K and downstream effectors in progressive, recurrent and poorly differentiated cancers, inhibition of the PI3K signaling pathway with BKM120, a potent pan class I PI3K inhibitor, represents a particularly relevant therapeutic target and should be properly evaluated in advanced follicular and poorly differentiated thyroid carcinomas

Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy (CONKO-007)

This randomized trial examines the effectiveness of chemoradiotherapy compared to chemotherapy alone after induction chemotherapy with 3 cycles of gemcitabine or 6 cycles of FOLFIRINOX in patients with locally advanced, non resectable and non-metastatic pancreatic cancer. Chemotherapeutic agent in chemoradiotherapy is gemcitabine administered in 5 cycles, the agent and its administration for sole chemotherapy is determined by induction chemotherapy. Operability of tumor is evaluated four weeks after end of treatment. Patients will be followed for the duration of therapy and for 5 years after the last study treatment. Overall survival at the end of follow up is defined as primary endpoint. Secondary endpoints are tumor-free survival, rate of local recurrence or local progression, rate of distant metastasis, acute and late toxicity of the chemoradiotherapy, quality of life, rate of remission, rate of curative resections (R0) after chemotherapy and chemoradiotherapy. It is planned to include a total number of 830 patients.

Short-term Investigation of Resveratrol on Fat Metabolism in Morbidly Obese Women Undergoing Gastric Bypass Surgery

The purpose of this study is to investigate potential metabolic effects of resveratrol in morbidly obese women undergoing gastric bypass surgery.

A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma

The purpose of this research study is to test the safety of an investigational new drug called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose levels. Vemurafenib has been approved by the United States Food and Drug Administration (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of unresectable or metastatic melanoma.

A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma

The purpose of this research study is to test the safety of an investigational new drug called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose levels. Vemurafenib has been approved by the United States Food and Drug Administration (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of unresectable or metastatic melanoma.

Evaluation Effects of Treatment With IL-6R Inhibitor on Clinical Response and Biomarkers in Patients With Rheumatoid Arthritis (RA) Not Responding to DMARDs and/or a First Biological Agent.

The purpose of this study is to assess the clinical response to IL-6 inhibition defined as Low Disease Activity (DAS44) <2.4) at the follow-up visit at 12 months and the correlation between the biomarkers and treatment response.

Risk of Falls in Fibromyalgia (FM)

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.

Neurodynamic Intervention in Fibromyalgia (FM)

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.

Effect of Vildagliptin vs. Glibenclamide on Circulating Endothelial Progenitor Cell Number Type 2 Diabetes1

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.

Physiotherapy in Exacerbation Chronic Obstructive Pulmonary Disease

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.

Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma

Preclinical studies at our institution, based on a genetic mouse model of stomach cancer, strongly suggest that innervation of the stomach wall is deeply involved in tumorigenesis of stomach cancer. The data indicate that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®)in the stomach wall inhibits the development of cancer as well as reduces already established tumor volume in the stomach in this mouse model. Gene expression data indicate that vagotomy suppresses protein gene product 9.5 (PGP9.5). The expression of PGP9.5 is highly specific for the density of neurons and the diffuse neuroendocrine system. The investigators will take biopsies from tumors and adjacent normal mucosa either by means of endoscopy and/or from operative specimens from participants treated or evaluated for stomach cancer at the Department of Gastrointestinal Surgery, St Olavs Hospital, Trondheim University Hospital. The biopsies will be evaluated with immunohistochemistry and gene expression studies for the presence and density of PGP9.5. These data will be correlated to stage evaluation (TNM) and survival.

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

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.

Vincristine or cis-platin, both in combination with gemcitabine or pemetrexed for the treatment of advanced non-small cell lung cancer – VIP trial

Primary objectives of the trial: quality of life; treatment side effects

Gastric Electrical Stimulation (GES) for the Treatment of Obesity

The purpose of this feasibility study is to provide safety data on the implantable Exilis gastric electrical stimulation (GES) system, to individually adjust stimulation parameters to levels that are comfortable for implanted subjects during chronic daily treatment, and to collect data on acute gastrointestinal function and food intake responses to GES during in-clinic testing.

Bone Healing in Healthy and Post-menopausal Osteoporotic Women

Both the pathogenesis and the treatment of osteoporosis may potentially interfere at different levels on the multi-stage complex cascade of events involved in bone healing/regeneration. To our knowledge no human studies have been performed to clarify the potential effect of osteoporosis on post-extraction alveolar healing. The primary outcome of the study is to compare alveolar bone changes in width and height 3 months after tooth extraction in 15 post-menopausal osteoporotic women and 15 healthy pre or post menopausal women by the use of cone-beam computer tomography (CBCT) images. As secondary outcome the investigators put: changes in the external contour of the ridge together with periodontal parameters in the neighbouring teeth, tissue blood perfusion changes during the initial healing (assessed by laser doppler flowmetry) and levels of serum bone resorption/formation markers.

Sutent Rechallenge In mRCC Patients (RESUME)

Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.

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

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.

Sutent Rechallenge In mRCC Patients (RESUME)

Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.

Safety and Efficacy of Buparlisib (BKM120) in Patients With Untreated Squamous Non-small Cell Lung Cancer (BASALT-2)

The Phase Ib part of the study aims to determine the maximum tolerated dose/recommended Phase II dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin and paclitaxel in patients with previously untreated metastatic squamous NSCLC. The purpose of the Phase II portion of the study is to assess the treatment effect of adding buparlisib versus buparlisib-matching placebo to every-three-week carboplatin and paclitaxel on progression free survival (PFS) in patients with previously untreated metastatic squamous NSCLC.

Cortical Excitability Changes Induced by Retigabine: a Transcranial Magnetic Stimulation Study (CERETI)

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.

Craniosacral Therapy to Treat Chronic Low Back Pain

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.

Obstructive Sleep Apneas in Elderly:Neuroimaging Changes and Neurocognitive Function Before and After Treatment

In the near future more than 20% of the European population will be over 65 years old and the prevalence of obstructive sleep apnea (OSA) in this aged population is known to be higher than 50%. OSA is a risk factor for cognitive dysfunction in middle-aged subjects, but the relationship between cognitive impairment and sleep breathing disorders (SBD) in the elderly has scarcely been observed. The aim of this study is to investigate cognitive performance in elderly OSA patients, the corresponding brain morphology changes and biological markers and their reversibility with continuous positive airway pressure (CPAP) treatment.

Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support

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.

Effects of metformin on hepatic free fatty acid metabolism in type 2 diabetes asssessed by positron emission tomography

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.

Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)

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.

A Study of Local Effect and Safety of a Single PPC-5650 Dose on Reflux Pain During Pain Stimulation in the Esophagus

The purpose of this trial is to evaluate the effect of a single PPC‐5650 dose in a human pain model including multimodal (mechanical, thermal, electrical, chemical) stimulations of the esophagus.

Atorvastatin and Prostate Cancer (ESTO1)

This single-center, randomized, double-blind trial assesses the impact of short-term atorvastatin administration on proliferation activity, apoptotic rate and histological inflammation in prostate tissue.

Effect of Rotigotine Patch Treatment on Cardiovascular Markers in Idiopathic Restless Legs Syndrome

The main aim of this study was to evaluate the impact of rotigotine patch treatment on validated cardiovascular risk factors ambulatory BP during night, day and night-to-day ratio, and endothelial function in patients with idiopathic RLS compared to placebo.

Executive Dysfunction in Restless Legs Syndrome: Clinical Correlates and Outcome After Therapeutic Management

Restless leg syndrome (RLS) is a common neurological disorder whose diagnosis is only clinical. The efficacy of dopaminergic agents in improvement of sensorimotor symptoms advance the hypothesis that altered dopaminergic transmission is at the origin of this condition. RLS usually leads to a sleep fragmentation, which induces sometimes severe insomnia most often associated, in clinical practice, to a cognitive complaint (attentional in nature). Executive functions in which dopaminergic transmission is heavily involved refer to a set of complex functions. At least three of them should be considered during their evaluation (ie flexibility, inhibition, and the updating of working memory). These functions are among the targets of the alteration of the quality and quantity of sleep. The few studies that have focused on the study of the integrity of executive functions in RLS have discordant results. The lack of control of key variables in the assessment of executive functioning (ie intellectual performance, depressive symptomatology, generalized slowing in information processing) and the lack of reference in the theoretical approach in executive functions are certainly the two main reasons. Moreover, the question of polysomnographic correlates and the reversibility of these cognitive abnormalities after pharmacological management of RLS remains unanswered today. The main objective of this study is to compare the executive performance of untreated RLS patients with a group of matched controls.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX 509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs

The main objectives are to evaluate the efficacy of VX 509 across a range of doses and to evaluate the early effect of VX 509 administration on joint structures as assessed by magnetic resonance imaging (MRI)

Botulinum Toxin for Stomach Cancer Treatment

Preclinical studies at our institution, using a genetic mouse model of gastric cancer, strongly suggest that innervation of the stomach wall is required not only for the development, but also for the progression of gastric cancer, and that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®) in the stomach wall may represent an effective therapeutic intervention. New treatment options for inoperable cancer in the stomach are urgently needed, and local treatment with botulinum toxin seems to be an attractive possibility. In this pilot study Botox injections will be given by gastroscopy in both the tumor and the surrounding stomach wall. The purpose of the study is to obtain data needed to calculate sample size in a larger controlled trial.

Atrial Fibrillation (AF) and Physical Exercise (EXAF)

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

Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients

Many decisions involve the possibility of gaining or losing relative to the status quo. The loss aversion behaviour is a cognitive concept explaining that people are more sensitive to the possibility of losing objects or money than they are to the possibility of gaining the same objects or amounts of money. We hypothesised that dopamine could be involved in the loss aversion behaviour. To highlight this, we have chosen a model of dopaminergic depletion : the Parkinson's disease The primary purpose of this protocol is to study the role of dopamine in the loss aversion phenomenon by comparing brain activity in parkinsonian patient with and without treatment with L Dopa, when they are exposed to mixed (gain/loss) gambles using money. The second purpose is to highlight the role of a dopamine depletion by comparing patient without treatment vs healthy paired control.

A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol and Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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.

The Effect of n-3 Polyunsaturated Fatty Acids in Patients With Psoriatic Arthritis

The aim of this study is to investigate the effect of daily supplementation with 3 g n-3 polyunsaturated fatty acids on risk markers for cardiovascular disease and inflammation in patients with psoriatic arthritis.

A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.

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

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.

Efficacy of Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of MS After a Clinically Isolated Syndrome (D-Lay-MS)

The main objective of this study is to evaluate the efficacy and tolerance of 2 years of treatment with cholecalciferol (vitamin D3) in patients with a clinically isolated syndrome at high risk for MS (CIS).

Sub-thalamic Nucleus Stimulation in Parkinson Disease (PARKEO)

Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of Parkinson's disease. This procedure performed in two steps using electrophysiology. This study is a prospective, randomized and monocentric study to compare two DBS procedures with or without electrophysiology. A better control of targeting and trajectory is necessary before not using electrophysiology, which is the reference procedure. A new definition of sub thalamic nuclei with new MRI stereotactic landmarks, the use of surgical robot (Neuromata Renishaw) and the use of operative imaging (O-arm) could allow the implantation of electrode in sub-thalamic nuclei without the need of electrophysiology. Two groups of patients will be followed: a first group of patients with a procedure under general anesthesia alone without electrophysiological stimulation and a second smaller group of patients with a first step of electrode implantation under awake surgery with electrophysiological stimulation followed by a second step under general anesthesia for the implantation of stimulator. Clinical results will be assessed at 6 months after implantation.

Phase I Trial: T4 Immunotherapy of Head and Neck Cancer

The overall goal of this study is to investigate the safety of T4 immunotherapy when administered to treat loco-regional disease in Squamous Cell Cancer of the Head and Neck (SCCHN) that is not suitable for conventional active therapy. The investigators propose to conduct an open-labelled, non-randomized, dose-escalation phase I trial in which autologous T4+ T-cells are administered to patients with SCCHN. T-cells will be engineered to express a second generation chimeric antigen receptor (CAR) named T1E28z. Engineered T-cells will be injected directly into the tumour site. Patients will not be lymphodepleted. A classical 3+3 design will be employed, with dose escalation from 10^7 through to 10^9 transduced T4+ T-cells, dependent upon toxicity monitoring. It is anticipated that up to 30 patients will be enrolled over the course of the study.

A Pilot Study of a Novel Technique for Cardiac Resynchronisation Therapy to Treat Heart Failure (LV-CONSEPT)

Cardiac resynchronisation therapy (CRT) is known to result in significant improvement in the symptoms of selected patients with heart failure, and to reduce hospital admission and death rates in these patients. CRT can improve cardiac function by improving the coordination of the heart beat using a special pacemaker. This requires a wire in the coronary sinus, one of the veins running around the outside of the heart, to stimulate the outside of the left ventricle (main pumping chamber). There are two particular issues with this standard technique. In some patients it is not possible to get the wire into the coronary sinus due to difficult vein shapes, and in others the wire can be put there, but it does not end up in a suitable position to act on the heart enough to improve heart function. This is thought to be a major part of the reasons why one in four patients does not improve with CRT ("non-responders"). The investigators have developed a novel method of pacing the left ventricle of the heart by putting the wire through a tiny hole made in the muscle between the left and right ventricles and pacing the inside surface of the left ventricular chamber. This will allow patients in whom the coronary sinus cannot be used to have CRT. The investigators will also offer it to patients who have not improved with CRT, as there is evidence that they may respond to this procedure due to physiological benefits from pacing the inside rather than the outside and also the ability to steer the lead anywhere on the inner surface. The investigators have performed this new procedure in a small number of patients already. This study will allow closer follow-up of more patients, and also investigation of ways to optimize results of the procedure for these patients.

Assessment of Bone Marrow-derived Cellular Therapy in Progressive Multiple Sclerosis (ACTiMuS)

The investigators recently completed one of the first feasibility/safety trials in the world of reparative bone marrow cell therapy in 6 patients with longstanding MS (www.nature.com/clpt/journal/v87/n6/full/clpt201044a.html). Safety was confirmed, and intensive repeated tests on the patients measuring nerve conduction in various pathways in the brain and in the spinal cord showed statistically significant improvements at 12 months in every patient. While highly preliminary and involving only a very small number of patients, these results at least raise the possibility of a significant (though very partial) underlying repair effect within the damaged nervous system. The investigators believe this urgently requires further testing - both to accelerate benefit for patients, and to begin improving therapeutic efficacy. The investigators therefore propose a programme of translational and clinical stem cell research, aiming (1) to continue translation with a phase two controlled trial of bone marrow cells in patients with longstanding MS; and (2) to explore in parallel the potential mechanisms of action, by studying bone marrow cells from treated patients and control subjects, aiming to establish which of the various relevant bone marrow subpopulations contribute to efficacy, and which particular reparative mechanism(s) are important. The investigators hope these studies will not only confirm the therapeutic benefit of this approach, but also provide the basis for improving the magnitude and impact of this novel and exciting treatment modality.

Cologne Cohort of Neutropenic Patients (CoCoNut)

The Cologne Cohort of Neutropenic Patients (CoCoNut) is a non-interventional cohort study assessing risk factors, interventions, and outcome of immunosuppressed patients with or without opportunistic infections.

TMMR Register Study (TMMR-RS)

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.

Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients (SENPARIC)

Use of Paricalcitol in stage Vd Chronic Kidney Disease patients, over the effect of inflammatory and oxidative stress parameters.

GLP-1 Receptor Targeting in Diabetic and Healthy Individuals (GLP-1-CPOP)

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.

New Methods to Measure the Immune Response to Hepatitis B Vaccine

Hepatitis B vaccine is a safe and effective vaccine used widely throughout the world. Because of this it is a useful vaccine in which to develop new methods for studying immune responses. Measuring the immune response to vaccines helps us to understand how they work and whether they are likely to protect any individual against infection. For most vaccines we measure the immune system's production of antibody after a vaccine has been given. The investigators want to develop new methods that give a far more detailed picture of the antibody response to vaccines than has previously been possible. These methods will investigate the genetic instructions used by each antibody producing cell to make antibody. These methods have the potential to give new insights into the way vaccines work, which could be applied to studying vaccines and vaccine schedules in the future.

A Phase I Study of Candidate Influenza Vaccines MVA-NP+M1 and ChAdOx1 NP+M1

This will be a randomised observational phase 1 study in 48 healthy volunteers aged 18-50. The study is assessing safety and immunogenicity of viral vectored vaccines ChAdOx1 NP+M1 and MVA NP+M1 in heterologous prime-boost regimens. A crossover design will allow comparison of the two vaccines. Volunteers will be divided into 4 groups (n=12 in each group). Groups will be recruited simultaneously to control for seasonal changes in influenza. This is because at certain times of year there is likely to be a higher naturally acquired T cell response to influenza than at other times due to circulating influenza virus in the community.

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

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.

Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer (ADAPT)

The trial will evaluate the optimal treatment with nab-paclitaxel in combination with either carboplatin or gemcitabine for patients with triple negative breast cancer.

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®)

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).

Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management (AIRPEDIA)

The aim of the study is to assess the cost-effectiveness of telemedicine in the care of chronic diabetic foot ulcers.

An Open,Single-centre Pilot Study of Efficacy and Safety of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO)

Assess efficacy and safety of topical MOB015B, applied daily during 48 weeks, in adults with fungal nail infection.

Acute Exercise and Pancreatic Endocrine Function

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.

Twentyfour Ambulatory Pulse Wave Velocity and Central Augmentation Index in Type 2 Diabetes

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.

Feasibility and Clinical Activity of Initial Intraperitoneal Catumaxomab Followed by Chemotherapy in Patients With Recurrent Ovarian Cancer

Single -arm, multicenter phase-II trial for catumaxomab and chemotherapy in patients with recurrent ovarian cancer to investigate the feasibility and clinical activity of initial intraperitoneal catumaxomab followed by chemotherapy regimes.

Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease and Progressive Supranuclear Palsy (GONDOPARK)

The purpose of this research study is to evaluate safety and effectiveness of Foot Mechanical stimulation to improving Gait and Gait Related Disorders in Parkinson Disease and Progressive Supranuclear Palsy both stable and with motor fluctuation.

A Pivotal Bioequivalence Study of DOXIL/CAELYX (Doxorubicin HCL) in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer

The purpose of this study is to support the qualification of a replacement manufacturing site for DOXIL/CAELYX (doxorubicin HCL).

NeoPHOEBE: Neoadjuvant Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive Primary Breast Cancer

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).

Economic Evaluation of Systemic Treatments for Moderate-to-severe Psoriasis

This study is health economic analysis of medicinal treatment options for moderate-to-severe psoriasis vulgaris from the societal perspective. Efficacy data and other clinical outcomes will be derived from an up-to-date meta-analysis of randomized clinical trials (RCTs) for moderate-to-severe psoriasis. Direct and indirect costs will be extracted from various different sources, including summary of product characteristics (SPCs) and the German S3 guideline on psoriasis care, health care utilization data and official statistics. The study aims to investigate the comparative cost-effectiveness of biologic and conventional systemic treatments currently (as of June 1st, 2012) approved for moderate-to-severe plaque-type psoriasis in Germany. Effectiveness will be measured by means of the pooled (Psoriasis Area and Severity Index) PASI-75 response rates as reported in RCTs Direct cost as well as indirect cost will be considered.

Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3% Inhalations

Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with no inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of hospital stay will be analyzed.

Effect of Andosan in Patients With Rheumatoid Arthritis (Andosan-RA)

Rheumatoid Arthritis (RA) is a chronic, autoimmune inflammatory disease that leads to significant pain, joint destruction and functional decline, and has a substantial economic impact both for sufferers and society. Although the etiology of RA is unknown, it is generally accepted that it arises from an interplay of genetic predisposition (in particular, HLA-DR allele subtypes and specific gene polymorphisms), immunological deregulation (e. g. autoantibody production), and environmental factors. The prevalence and incidence of RA in Norway is estimated to 0,4-0,5 % and 0,020-0,025 %, respectively, and incidence rates are 2-4-fold higher in women. Synovitis and bone resorption are key pathogenetic factors in RA and these patients have elevated cytokine levels in joints and blood (i.e. TNF, IL-1, IL-6). RA is also associated with significant comorbidity; the most important is premature cardiovascular disease that significantly contributes to increased mortality. Compared with the general population, mortality in RA is from 1,57-2,0-fold higher in Norway and Sweden, and their mean life expectancy is reduced by an average of 5-10 years. Medical treatment of RA consists of nonsteroidal anti-inflammatory drugs, systemic glucocorticosteroids, traditional disease modifying antirheumatic drugs (including methotrexate) and biologic therapies (including anti-tumor necrosis factor (TNF) α, anti-IL 6 and anti-CD20 therapy). Also, a considerable portion of the patients are in need of joint replacement surgery and in need of rehabilitation. However, the treatment opportunities are still not optimal. In a large proportion of the patients, full control of the disease is not possible due to limited effect of available therapies and/or intolerance to these therapies. Therefore, there is a huge need to find new therapeutic alternatives to treat RA. Since studies on healthy volunteers and IBD-patients support that the mushroom extract AndoSanTM exert an anti-inflammatory effect in vivo, the investigators wanted to examine in a pilot study whether this effect also was evident in patients with RA. A potential anti-inflammatory effect could prove beneficial in these seriously ill patients, who accordingly could experience less side effects (edema, granulocytopenia, diminished tissue repair) due to potential reduction number and dose of disease modifying drugs.

The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent (BIOHELIX-II)

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.

Painful Knee Prosthesis. Relationship Between Endogenous Analgesia and Persistent Post Surgical Pain.

This is a prospective, observational study, aimed to establish the relationship between an inefficient endogenous pain modulation before surgery (total knee arthroplasty; TKA) and the probability to develop chronic pain after surgery (persistent post surgical pain). Endogenous analgesia efficiency will be measured during the month previous to surgery using quantitative sensory testing (QST). Persistent post surgical pain will be defined as presence of pain in movement greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.

Phase Ia Study of ChAd63/MVA PvDBP

This is an open label phase Ia study, to assess the safety of two novel malaria vaccines, ChAd63 PvDBP, with or without MVA PvDBP. Heterologous prime-boost with ChAd63-MVA is, to our knowledge, one of the most potent T cell-inducing subunit vaccine regimens which can importantly also induce antibodies. Previous clinical trials using this regimen expressing ME-TRAP, AMA1 & MSP1, have shown that administering ChAd63 as a prime followed 8 weeks later by MVA as a boost is a very immunogenic schedule (32-34). For this reason, and to provide comparability with previous ChAd63-MVA trials, we propose to use a similar administration schedule.

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

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

A Phase 2b/3 Multicenter, Randomized, Double-Masked, Dose-Ranging Study Comparing the Efficacy and Safety of Emixustat Hydrochloride (ACU-4429) with Placebo for the Treatment of Geographic Atrophy Associated with Dry Age-Related Macular Degeneration

To determine if ACU-4429 reduces the rate of progression of geographic atrophy (GA) compared to placebo in subjects with dry age-related macular degeneration (AMD).

Agomelatine Treatment of Depression in Schizophrenia (AGOPSYCH)

Major depressive episodes (MDEs) occur frequently during the course of psychotic disorders, and several antidepressive agents have been successfully applied. The new melatonergic antidepressant agomelatine (AGO) appears promising for the treatment of MDEs in schizophrenia for several reasons. The investigators plan to test the efficacy and tolerability of AGO for antidepressive treatment in schizophrenia. For this task, the investigators plan to enrol 27 schizophrenic patients into an open, single-armed, prospective clinical trial with agomelatine.

Impact of CPAP Therapy in Obstructive Sleep Apnea on Parameters of Nocturnal Pulse Wave Analysis

The present study aims to document and assess changes in single parameters of pulse wave analysis (ASI single parameters) as well as to evaluate ASI cardiovascular risk assessment before initiation of CPAP therapy and after 6 months of CPAP therapy in patients with obstructive sleep apnea.

Phase II Study of the Optimal Scheme of Administration of Pazopanib in Thyroid Carcinoma

The objective of this study is to determine the feasibility of pazopanib treatment interruption with reintroduction at progression in iodine refractory progressive Differentiated Thyroid Cancer (DTC) patients as compared to pazopanib continuous administration.

Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®.

Total knee arthroplasty represents over 70 000 surgical procedures per year in France, increasing about 10% each year since the early 1990s. Clinical experience shows a strong rate of success on pain relieve and improvement of knee articular function for these patients. Longevity of the implants had been proved to depend on the biomechanical design and implantation techniques, particularly the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta company allows to adapt bone cuts to the patient anatomy improving the reliability of these procedure. A reduction of surgical time and bleeding would be another benefit expected with this type of ancillary. The objective of this study is to demonstrate the advantage of patient matched cutting blocks for total knee arthroplasty on realiability for both clinical and radiological criteria, morbidity reduction during and after the procedure and also a benefit on an economic point of view.

Autologous Adipose Tissue Derived Mesenchymal Progenitor Cells Therapy for Patients With Knee Osteoarthritis

Three injections each of 3 ml autologous adipose tissue derived progenitor cells, time-points for intervention: 1) initial injection; 2) 1 months following initial injection and 3) 3 months following initial injection. This result in a total treatment duration of 3 months.

Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) Trial

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.

Does Posterior Reconstruction of the Rhabdosphincter Improve Early Recovery of Continence After Robotic-Assisted Radical Prostatectomy? (PRR)

The present study is a multicenter randomized, controlled trial, whose aim is to verify the effect of the posterior reconstruction of the rhabdosphincter after robot-assisted radical prostatectomy on early recovery of urinary continence.

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.

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.

The Effect of Minocycline on Relapse After Successful Intravenous Ketamine/Minocycline-induced Symptoms Response in Subjects With Depression

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.

THISTLE - The HIV-HCV Silibinin Trial

Chronic hepatitis C virus (HCV) is a major cause of morbidity and mortality worldwide with an estimated number of 180 million infected patients. Until 2012 the current standard of care (SOC) treatment of patients with chronic hepatitis C was a 24 to 72 weeks therapy with pegylated interferon- and ribavirin (PR). In 2012, the protease-inhibitors (PI's) telaprevir and boceprevir as first directly acting HCV drugs have been approved by the local Swiss authority for hepatitis C mono-infected and HCV-HIV-co-infected individuals. However, therapy success is strongly limited in null-responders (NR) to previous PR. Treatment of HCV-HIV co-infected individuals with the new PI's is accompanied by additional challenges (e.g. drug-drug interactions, toxicity, high pill burden). Patients with advanced fibrosis are at highest risk for decompensated liver disease and hepatocellular carcinoma (HCC) and prompt initiation of treatment is strongly recommended. Recently, data in mono-infected patients showed, that in prior non responders a 12 week course of a triple therapy (TT) with telaprevir and PR followed by another 24 weeks of PR resulted in an sustained virologic response (SVR) of only 29%. In HCV-HIV co-infected non-responders with unfavourable preconditions (e.g. HCV-genotype 1, interleukin 28 B non-CC genotype, advanced liver fibrosis, high baseline HCV viral load) SVR after TT is even expected to be lower. These patients urgently need additional therapeutic options with the goal to eradicate HCV in order to prevent further fibrosis progression and to reduce morbidity and mortality. A promising substance in the field of drugs targeting the HCV replication is silibinin. Silibinin is the main component of silymarin, an extract of the milk thistle Silybum marianum. Intravenous silibinin (iSIL) targets multiple steps in the virus life cycle and exhibits anti-oxidant, anti-inflammatory, anti-viral and immunomodulatory properties. iSIL inhibits the HCV NS5B polymerase activity directly or by interfering with the binding of RNA to this enzyme. In addition, iSIL appears to block virus entry, virus transmission and virus secretion.In 2008 Ferenci et al. for the first time reported the substantial clinical antiviral-effect of intravenous silibinin (iSIL) against HCV in PR non-responders. The administration of 20mg/kg iSIL in 20 patients led to a highly significant decrease in viral load. We intend to investigate the effect and tolerability of iSIL in HIV-HCV co-infected individuals with advanced liver fibrosis and previous non- or partial response to SOC. All included study-subjects will receive a lead-in therapy with iSIL in a dosage of 20mg/kg/day (expressed as silibinin concentration) once a day for 14 days. At the end of the THISTLE study, i.e. after the day of completion of the 14-day iSIL administration (day 15), the patients will be considered for eligibility to receive standard of care. We assume that the decline in HCV viral load would substantially improve the chances of SVR as the reduction of viral load should both increase the efficacy of PR and reduce the odds of drug resistance to HCV-specific protease inhibitor.

Intraperitoneal Aerosol High-pressure Chemotherapy for Women With Recurrent Ovarian Cancer

This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure chemotherapy in women with recurrent ovarian cancer

Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions (TPVB)

Percutaneous radiofrequency ablation of liver lesions causes patients acute pain during and after the procedure. During the procedure patients need deep sedation and cannot be collaborative. Furthermore post-operative analgesia is necessary. The aim of this study is to evaluate if the ultrasound-guided paravertebral block (TPVB)with a single injection can provide anesthesia and post-operative analgesia in these patients.

Assess Safety & Efficacy of Selumetinib When Given in Combination With Standard First Line Treatment for Advanced Non-small Cell Lung Cancer (NSCLC)

This study will treat patients with advanced NSCLC with a combination of standard first line platinum-containing doublet chemotherapy and selumetinib. It will help to understand what is the best tolerated combination of doses of the three agents, and what type of side effects may occur when the three agents are given in combination. In addition all patients will be assessed for anti-cancer efficacy of the combination of selumetinib and chemotherapy.

Study of Weekly Radiotherapy for Bladder Cancer (HYBRID)

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.

A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia

To determine noninferiority (NI) in early clinical response rate (defined as improvement at 72 [±12] hours after the first dose of study drug), in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production, (without worsening of any) of oral solithromycin compared to oral moxifloxacin in adult patients with community-acquired bacterial pneumonia (CABP) in the Intent to Treat (ITT) population.

A Randomized, Open-Label Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Single and Multiple Doses of Armodafinil (50, 100, and 150 mg/day) in Children and Adolescents with Excessive Sleepiness Associated With Narcolepsy

The primary objective of this study is to characterize the single- and multiple-dose pharmacokinetics of armodafinil and its major circulating metabolites (R-modafinil acid and modafinil sulfone) in children and adolescents with excessive sleepiness associated with narcolepsy.

Study Comparing the Efficacy and Safety of Continuing Versus Withdrawing Adalimumab Therapy in Maintaining Remission in Subjects With Non-Radiographic Axial Spondyloarthritis

This is a Multicenter, randomized, double-blind study in subjects with moderate to severe non-radiographic Axial Spondyloarthritis. There is a 28-week open-label period followed by a 40-week double-blind, placebo-controlled period for subjects who meet the randomization criteria. Subjects who flare during the double-blind period will have an opportunity to receive at least 12-weeks of rescue therapy.

A Follow-up Study on Safety and Tolerability of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease

The purpose of this study is to document the long-term safety and tolerability after intracerebroventricular (ICV) administration of sNN0031 (PDGF-BB) in patients who participated in study sNN0031-001

ICCM of Common Childhood Diseases: Mozambique and Uganda (inSCALE)

The aim of the inSCALE project is to test the effect of innovative approaches to increase coverage of integrated community case management, which provides community based-care for diarrhoea, pneumonia and malaria, resulting in more children receiving timely and appropriate care for these three most common childhood illnesses

A First Time in Human Study Exploring Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis (RRMS)

This is a 3-part study where Parts A, B (single-blind - investigator and subject blind) will enrol healthy volunteers and Part C (open-label) will enrol RRMS patients. Parts A (single ascending dose) and B (repeat ascending dose) will assess safety, tolerability, PK and PD of GSK2618960. Part C (repeat doses) will assess safety, tolerability, PK, PD, immunogenicity, paraclinical (magnetic resonance imaging [MRI] lesion counts) disease activity and markers of Th1 and Th17 mechanisms. Part A: Each of the 24 healthy volunteers (divided in 5 groups), will take part in only 2 of the planned 8 dosing sessions (A-active, P-placebo). Subjects in each group of Part A will be randomized in a 2:1:1 ratio to one of the following sequences: AA, AP or PA such that in each dosing session they will receive study treatment in a 3:1 ratio of active: placebo respectively. Part B: Dosing levels and regimen are dependent upon safety tolerability and PK/receptor occupancy (RO) data from Part A. In Cohort 1, 12 subjects will be randomized in a 3:1 ratio to A or P. Each subject will receive the same study treatment for repeated doses. If the duration of full RO from highest dose in Part A is less than 4 weeks, a second cohort of 12 subjects in Part B may be recruited, based on Dose Escalation Committee (DEC) decision Part C: The 20 RRMS patients will be assigned to active treatments for 2 to 4 repeated doses. Safety/tolerability and PK data monitoring and the decision to proceed to the next dose level of GSK2618960, and the decisions to proceed to Part B and Part C of the study will be made by a dose escalation committee.

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

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?

Cholesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant Patients (CHOLESS)

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.

Internetbased Relapse Prevention for Partially Remitted Depression (ISAK)

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.

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

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

Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on Periodontium (ParoPAR)

Rheumatoid arthritis and periodontitis are two inflammatory diseases that share many pathophysiological similarities as some inflammatory mediators like TNF-alpha, IL-1, Il-6, Il-17, Il-12 et Il-17, RANK-L, or OPG The most severe or progressive forms of rheumatoid arthritis require in 10-30% of cases, the use of biotherapies such as anti-TNF-alpha, anti CD-20 and anti-lL-6. All these treatments results in, among other things, an increased risk of infection, both viral and bacterial. These new biotherapies could have an impact on periodontal status - either by favouring sub gingival colonization of root surfaces by periodontal pathogenic bacteria and initiate periodontitis or exacerbate pre-existing periodontitis, - or a positive modulation of the host response by inhibiting bone resorption of the alveolar process. To date, very few studies have been conducted on this subject which is really a translational research, involving several medical specialties.

Correlation Between Haptoglobin Phenotypes and Infectious and Other Complications in Cystic Fibrosis Patients (Hp-in-CF)

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.

Satisfaction/Quality of Life With Rivaroxaban in DVT (Deep Venous Thrombosis) Indication (SATORI)

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 in deep venous thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) 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.

Open-label, Single Arm, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered with Ribavirin (RBV) in Adult Liver Transplant Recipients with Genotype 1 Hepatitis C Virus (HCV) Infection

The primary objectives of this study are to assess safety and efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 (HCV ribonucleic acid [RNA] < lower limit of quantification [LLOQ] 12 weeks following treatment) of coformulated ABT-450/r and ABT-267 (ABT-450/r/ABT-267) and ABT-333 coadministered with RBV for 24 weeks in HCV genotype 1-infected adult liver transplant recipients.

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

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.

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

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.

Non-invasive and Invasive Assessment of Coronary Artery Disease (COMFORT)

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.

Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Normal Population (CONTROL)

This study intends to explore the levels of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum in the normal population. This study is important for establishing a baseline to analyze results obtained in MS patients (another dedicated study is performed in parallel in MS patients). The study will be conducted over one year in a cohort of healthy subjects. The MSRV RNA level, MSRV-Env protein levels, reverse transcriptase activity, inflammatory markers assessed by cytokines levels will be analysed to define control levels in the normal population and their variation during one year. The data obtained in this study in healthy controls will be compared to those obtained in a parallel similar study, GN-E-002, conducted in different types of MS patients.

Atu027 Plus Gemcitabine in Advanced or Metastatic Pancreatic Cancer (Atu027-I-02)

The purpose of the study is to evaluate a new treatment strategy for advanced pancreatic cancer disease by combining the new investigational medicinal product Atu027 with the standard chemotherapeutic gemcitabine. This combination aims at enhancing gemcitabine´s anti-tumor activity with Atu027. The objectives of this clinical trial are to evaluate safety and activity of two Atu027 schedules in combination with standard gemcitabine treatment in patients with advanced or metastatic pancreatic adenocarcinoma.

Study of Safety and Tolerability of BPS804 in Patients With Late-stage Chronic Kidney Disease

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.

Efficacy Study of Neridronate to Treat Painful Osteoarthritis of the Knee With Bone Marrow Lesions.

The purpose of this study is to determine whether neridronate is effective in the treatment of pain related to bone marrow oedema in patients with osteoarthritis of the knee.

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

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.

Functional Anatomical Examination of Axillary Sentinel Lymph Node Drainage in the Axillary Subregions in Early Breast Cancer

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.

RAS Blockade at Bedtime Versus on Awakening for Aldosterone Breakthrough (IRAB2)

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.

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.

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).

Study of Association Between Digital Osteoarthritis and Lower Limb Osteoarthritis (Khoala)

Among the risk factors for lower limb osteoarthritis, if obesity is probably the most studied, digital osteoarthritis received increasing interest in recent years. Recent publications have highlighted a link between obesity and digital osteoarthritis, but also a very probable link between digital osteoarthritis and structural progression of knee osteoarthritis. Few data including hip exist and need to be confirmed on larger scale studies. We have with "Khoala" a national multiregional cohort of symptomatic gonarthrosis and coxarthrosis representative of the general population (which is rarely the case in the literature) including X ray, clinical and biological follow-up (hips and / or knees).

RAS Blockade at Bedtime Versus on Awakening for Aldosterone Breakthrough (IRAB2)

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.

A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia

The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia

MIBRAIN - Migraine and the Brain: Consequences, Causes, and Vascular Interaction

Migraine is a very common, chronic/intermittent and disabling neurovascular headache disorder that has long believed to have no severe consequences. Recent evidence, however, strongly suggest that migraine is associated with increased risk of ischemic stroke and there is initial evidence that migraine is associated with structural brain changes independent of the occurrence of stroke. As migraine has strong links with the vascular system, it is plausible that vascular functions interact on the association between migraine and structural brain changes as well as cognition. Our primary objectives are to investigate: (i) the relationship of migraine and migraine subtypes on magnetic resonance imaging (MRI) changes in a cohort of patients with active migraine; (ii) the relationship of migraine on cognitive performance among patients with active migraine; and (iii) the relationship of migraine and migraine specifics with vascular functions and morbidity. As secondary objective, we investigate whether the association of migraine on structural brain changes or cognitive performance is modified by vascular functions.

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

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

Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer (MITO16MANGO2b)

Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab. Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined. This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.

Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (DASAPOST)

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.

Pharmacokinetic and Pharmacodynamic Evaluation of Linezolid Administered Intravenously in MRSA-positive, Morbidly Obese Patients With Pneumonia (UGENT_LIMOP)

The objectives of the study are: (i) to evaluate the proportion of patients who attain a T>MIC (Minimum Inhibitory Concentration) of 100% and the time frame in which they do so. The investigators therefore plan to measure unbound linezolid trough concentrations before administration of the second, third, fourth and fifth dose. Furthermore, the investigators will assess the AUC0 - 24h/MIC in all study subjects. Therefore, multiple plasma samples will be drawn after the fourth or fifth dose, when steady state conditions are reached. (ii) to describe the pharmacokinetic variability of unbound linezolid concentrations in this cohort using a population pharmacokinetic model and to assess the expected probability of target attainment (PTA) by MIC against MRSA.

Prescription and Utilization of Low Molecular Weight Heparin in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism in Patients With Cancer

The study purpose is to document the prescription and the use of Low Molecular Weight Heparin in usual medical practice in patients with cancer and established Venous Thromboembolism. This study also aims at gathering epidemiological data on the Low Molecular Weight Heparin therapy of Venous Thromboembolism in patients with cancer.

A Randomized, Multicenter Study to Evaluate Cardiovascular Outcomes with ITCA 650 in Patients Treated with Standard of Care for Type 2 Diabetes

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.

Assessment of Attentional and Executive Disorders in Multiple Sclerosis Using Techniques of Virtual Reality (SEPREV)

Since many years cognitive disorders are a main topic of clinical research in Multiple Sclerosis (MS) as there could be observed early on in the disease and could induce with time in patients significant socio-professional burden. Today assessment of cognitive dysfunction in MS is still based on traditional pencil-paper task tests which are not able to give a true representation of functional burden observed in patients in real life situations. The development of new tools close to these "life situations", i.e. more ecological, are needed to better assess and take in charge cognitive impairment in MS patients. One way to reach this goal is Virtual Reality (VR). VR offers a new human-computer interface paradigm that simulates a realistic 3D environment where the user become immersed and interacts with it. These last ten years VR has known a rapid development in the health domain and has been applied with success to motor rehabilitation, psychiatry and neuropsychology. In this last domain, virtual environment (VE) reproducing activities of daily living have been used to evaluate executive and memory functions as well as attentional or visuospatial processes. Among main VE developed, driving assessment system, navigation skills, cooking behaviors, virtual supermarket have shown better sensitivity to detect functional consequences of cognitive impairment in various neurological and psychiatric disorders than traditional evaluations. In Caen University Hospital, investigators used VE driving system and developed the use of the Virtual Action Planning in a supermarket (VAP-S ; Klinger et al 2004) where a user move to select and buy groceries and other things inside an interactive virtual supermarket using a shopping cart. In a preliminary study investigators have used this virtual interactive tool to evaluate executive functioning in small group of Parkinson's disease and MS patients. Analysis of initial data shows the feasibility of the VAP-S for use with these two kinds of diseases. According to these results investigators planned a new study in Relapsing-Remitting(RR)- MS patients where they compare the use of VE (driving system and the VAP-S) to traditional attentional and executive evaluation for estimate their respective sensitivity to detect cognitive/functional impairment in MS patients. Investigators hope to shown that VR will demonstrate its interest to assess cognitive functions in MS and to develop cognitive rehabilitation.

A prospective, open, randomized, academic phase II, two-arm trial evaluating the effect of fibrin-coated collagen (TachoSil®) on postoperative pancreatic leakage and fistula formation from the pancreato-enteric anastomosis in patients undergoing partial pancreaticoduodenectomy

To demonstrate that fibrin-coated collagen patch (TachoSil) significantly decreases postoperative pancreatic leakage and prevents pancreatic fistula formation in patients undergoing partial pancreatico-duodenectomy with pancreato-enteric anastomosis

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

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).

Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy (NEURISK)

The purpose of this study is to identify prognostic factors and to develop predictive models of risk of febrile neutropenia and neutropenia grade 3/4 in patients with solid tumors receiving chemotherapy with schemas that have an inherent risk of febrile neutropenia of 10-20%.

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

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.

Assessment of the Subcutaneous Reinjection of Human Autologous Adipose-derived Stromal Vascular Fraction (Celution® System) in the Hands of Patients Suffering From Systemic Sclerosis

This is a clinical study evaluating an innovative cell therapy procedure. The objective of this study was to evaluate the effects of injection of autologous stromal vascular fraction of adipose origin according to the system Celution ® (Cytori Therapeutics, Inc.., United Kingdom) in digital in patients with scleroderma cutaneous hands.

A Study to Assess the Pharmacokinetics and Pharmacodynamics of JNJ-54452840 in Participants With Heart Failure and Anti-beta1-adrenergic Receptor Autoantibodies

The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of JNJ-54452840 in participants with heart failure and anti-beta1-adrenergic receptor autoantibodies. The safety and tolerability of JNJ-54452840 will also be assessed.

Trial of Autonomic neuroModulation for trEatment of Chronic Heart Failure (TAME-HF)

The purpose of this clinical investigation is to evaluate the safety and efficacy of Spinal Cord Stimulation (SCS) in advanced heart failure (HF) patients with Implantable Cardioverter Defibrillator (ICD) but not indicated for Cardiac Resynchronization Therapy (CRT).

An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Ribavirin Based Regimens in Patients With Chronic Hepatitis C With Previous Treatment Failure

This prospective, national, multicenter, observational study will evaluate in routine clinical practice the efficacy and safety of re-treatment with Pegasys (peginterferon alfa-2a) plus ribavirin or regimens containing direct-acting antivirals in patients with chronic hepatitis C who failed previous treatment. Patients will be followed for the duration of their treatment (24, 48 or 72 weeks) and for 24 weeks of follow-up.

A Rising Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics of MK-8892 (MK-8892-001)

This study will evaluate safety, tolerability and effects on central diastolic blood pressure (cDBP) of MK-8892 given as single oral doses in healthy male participants (Panel A and B) and in male participants with mild-to-moderate hypertension (Panel C).

A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma

A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 30 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed

Vision Restoration Training in Glaucoma (VRT-G)

Importance: Visual field loss after retinal damage in glaucoma is considered irreversible and methods are needed to achieve vision restoration. Behavioral vision restoration training (VRT), shown to improve visual fields in hemianopia and optic nerve damage, might comprise such a method. Objective: To determine if behaviorally activating areas of residual visual (ARV) using VRT by daily one hour training for 3 months improves detection performance in perimetry compared to a vision discrimination task in the intact visual field sector.

Study of Cartilage Relaxometry and Physical Activity in Osteoarthritis

This study is the radiological component of an earlier registered RCT under the title: Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee Osteoarthritis. The main purpose in this component of the study is to evaluate the efficacy of aerobic exercise and strength training on the T2 and T1 rho relaxation times of the articular cartilage. It has been proven that exercise can improve function and reduce the need for analgesics in patients with osteoarthritis. With this study, we wish to investigate if different kinds of exercise can cause measurable improvements in T2 and T1 rho relaxation times of the articular cartilage, and also if this improvements are transient or permanent.

Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip

The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip

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)

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

Assessment of Clinical Practice Administration of Chemotherapy and Anti-angiogenic Agent (Bevacizumab) in Colorectal Cancer

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.

Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin (D-LITE)

Substudy C: The purpose of this substudy is to determine whether Lambda combined with Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with genotype 1b chronic HCV infection

Follow-up Study After 11 Years of Patients Who Were Included in the BENEFIT Trial (304747) With a First Demyelinating Event Suggestive of Multiple Sclerosis

This study assesses clinical and imaging long-term data, after early or delayed interferon-beta-1b treatment in patients with a first demyelinating event suggestive of multiple sclerosis (MS), 11 years after enrollment in the Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study (304747). The main objectives are to describe the disease course, change in disability, cognitive function, resource use and employment status, in relation to Interferon beta-1b in the long term.

A Single-Arm, Multicenter, Open-Label, Phase 2 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

The primary objective of this study is to estimate the best objective response rates (ORR; complete response [CR] + partial response [PR]) associated with gemcitabine-cisplatin plus necitumumab in chemotherapy-naïve patients with Stage IV squamous cell NSCLC.

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

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

Manipulative Therapy Techniques to Treat Chronic Low Back Pain

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

A Phase I/II Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-01)

This study is a phase I/II, open-label study in patients with relapsed CD37 positive non-Hodgkin lymphoma. The Phase I part of the study is a dose escalating study to define the maximum tolerable dose of 177Lu-DOTA-HH1 (Betalutin), assess safety and toxicity, pharmacokinetics, biodistribution and efficacy. After completion of the phase I study, a dose will be selected for the phase II part of the study which is designed to investigate tumour response rate, progression free survival, confirmation of the selected dose as well as safety and toxicity.

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

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.

Obstructive Sleep Apnoea in Patients With Intermittent Claudication (WITH-SAS)

The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication.

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.

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

Prospective Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.

The primary objective of the present trial is to investigate, clinical feasibility of the GERDx™ device, evaluating surgical aspects, quality of life, and symptom sores. Secondary objective of the trail is to evaluate objective data before and after the procedure, using manometry and 24h impedeance measurement

Neurodevelopmental Outcome of Early Dietary Lysine Restriction in Pyridoxine Dependent Epilepsy Patients (NOEL)

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.

International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010

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.

LungTech: Stereotactic Body Radiotherapy (SBRT) of Inoperable Centrally Located NSCLC

The main purpose of this trial is to assess the effectiveness of IG-SBRT (Image guided stereotactic body radiotherapy) in patients with medically inoperable early stage, centrally located NSCLC and in those who are not willing to undergo surgical treatment. Secondary objectives of the study are - to assess safety of the treatment modality by collecting data about acute and late toxicity - patterns of local and distant recurrence and relation between the site of local recurrence and the clinical (CTV) and planning target volume (PTV) - survival and cause of death

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

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.

Phase I Study Evaluating the Treatment of Patients With Locally Advanced Pancreatic Cancer With Carbon Ion Radiotherapy: The PHOENIX-01 Trial

The physical and biological properties of the carbon ion beam promise to improve the therapeutic ratio in patients with pancreatic cancer: Due to the inverted dose profile dose deposition in the entry channel of the beam leads to sparing of normal tissue; the Bragg peak can be directed into the defined target volume, and the sharp dose fall-off thereafter again spares normal tissue behind the target volume. The higher RBE of carbon ions, which has been shown also for pancreatic cancer cell lines in the preclinical setting, is likely to contribute to an increase in local control, and perhaps in OS. Early data from Japanese centers have shown convincing results. The PHOENIX-01 trial is the first trial to evaluate actively delivered carbon ion beams in patients with locally advanced pancreatic cancer within a dose-escalation strategy.

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.

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.

An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues

This observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues. Data will be collected from patients treated according to the current Summary of Product Characteristics and local standard of care and regulations during 48 weeks of treatment and 24 weeks of follow-up.

Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving CPAP Compliance in Low Cardiovascular Risk Sleep Apnea Patients : OPTISAS 1 Study

To compare 6-months CPAP compliance when Sleep Apnea patients at low cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform

Phase 1-2 Study of Total Bone Marrow Irradiation With Helicoidal Tomotherapy in 1st Myeloma Relapse (TOMMY)

In Multiple Myeloma, an adult hematological malignancy, mainly located in the Bone Marrow (BM), dramatic recent progresses have been observed, thanks to new agents (proteasome inhibitors and IMIDs). However, at time of first relapse, high-dose therapy followed by Stem Cell Rescue (SCR) is frequently mandatory as a consolidation in minimal residual disease, to healthy patients under 65 yo, combining Melphalan (MPH) and/or Total Body Irradiation. Modern irradiation modalities are now available by the use of HI-ART Tomotherapy system to realize a Total Bone Marrow Irradiation (TBMI), in order both to limit the dose administered to Organ at Risk (lungs, oral cavity) and to focus efficacy on BM. In this phase-1 study, the conditioning regimen before SCR will combine a fixed high-dose MPH (140 mg/m²) and a dose escalated TBMI, so as to define its Maximal Tolerated Dose (MTD) and the Dose Limiting Toxicities (DLT). An extended cohort will further in a phase-2 setting.

Influence of Muscle Strength on the Energy Cost of Walking in Obese Subjects (OBELIX)

The purpose of this study is to evaluate the efficacy of 2 physical exercise training programs, with a supplementation in fruits and vegetables, on energy cost of walking. 60 subjects will be randomized into 2 groups. The first program will be consist of an interval strength training for 30 min on bicycle ergometer (which include strengthening exercises in an high intensity interval training). The second program will be conducted at a relatively low intensity of effort, corresponding to 50% of oxygen uptake (VO2) peak measured by indirect calorimetry. All subjects will receive a free supplement of 5 fruits and vegetables per day during all the intervention. The intervention will last 10 months in total : 5 month at the hospital fallow by 5 month at home.

Study on Ocular Blood Flow and the Orbital Cerebrospinal Fluid Pressure in Glaucoma

Ocular blood flow has been consistently demonstrated to be altered in glaucoma patients when compared to otherwise healthy individuals. Numerous Doppler studies have shown a decrease in flow velocities in the retrobulbar arteries in what appears to be related to the degree of the glaucomatous disease. The anatomic pathway of the several arteries into the eye is intricately complicate, with at least one of them (the central retina artery) penetrating the optic nerve before entering the eye and supplying the innermost structures of the globe. As the optic nerve is surrounded by a layer of cerebrospinal fluid (CSF) which is in continuity with the rest of the central nervous system, this central retinal artery has also to cross this CSF containing compartment. Because of the intrinsic pressure this CSF - corresponding to the intracranial pressure at the orbital level - the possibility exists that this pressure around the optic disc could affect the blood flow of the arteries that go through it. The investigators will try to detect if a correlation exists between the optic nerve sheath diameter and the blood flow in the retrobulbar vessels of glaucoma patients.

Occupational Therapy and Surgery in Carpometacarpal Osteoarthritis

The purpose of the study is to investigate if occupational therapy may delay or prevent the need for surgery in the patients with carpometacarpal(CMC) osteoarthritis who are scheduled for surgery in the CMC-joint. Our study hypothesis is that compared to participants in the intervention group, significantly more participants in the control group have received CMC-surgery after two years.

Risk Factors of Complications Regarding Patients Undergoing Brain Tumour Neuro-surgery (Cranioscore).

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.

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

Estimate the clinical benefit of lapatinib plus trastuzumab compared to lapatinib plus capecitabine as measured by investigator-assessed progression-free survival (PFS)

Monitoring of Lung Sounds of Patients With Pneumonia

The aim of this study is to investigate if any correlation between lung sounds of pneumonia patients and the clinical development or therapy of the pneumonia exists.

A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)

The main purpose of the study is to evaluate the efficacy and safety of the study drug known as prasugrel for the reduction of Vaso-Occlusive Crisis events in pediatric participants with sickle cell disease. The study will also investigate reduction in daily pain in children who have sickle cell disease.

A Study Comparing AZD2014 vs Everolimus in Patients With Metastatic Renal Cancer (ZEBRA)

When kidney cancer spreads beyond the kidney, it is known as metastatic kidney cancer. This is very difficult to treat and almost all patients will die of their disease within 2 years of the dignosis. Sunitinib and other related drugs (e.g. pazopanib) have become standard therapy for untreated patients with metastatic kidney cancer. They target a growth factor known as VEGF which is important in treating kidney cancer. Although the results with this drug are impressive, patients develop resistance to the drug and stop therapy. It is currently standard practice is to give everolimus when resistance to sunitinib occurs; this is associated with clear clinical benefit. However the average time to cancer regrowth with everolimus is only 5 months. It is thought this might be because, everolimus only partially inhibits its target (TORC 1 and TORC 2). Therefore further improvement in treating patients is required. AZD2014 is a promising new drug which does inhibit both TORC 1 and TORC 2 and is therefore worthy of investigation in renal cancer as it theoretically could may have advantages over everolimus. Therefore study compares AZD2014 to everolimus in the setting where everolimus is used as standard of care. (e.g. in patients who have failed drug like sunitinib). The study is a randomised trial allowing us to quantify the benefit and potential for further development of AZD2014. Repeat Xrays (CT scans) will be used to assess if the new drug delays tumour growth. Patients will be closely followed up in clinic to ensure safety. A maximum of 122 patients will be recruited into this multi centre national trial. The primary goal of the study is to investigate if AZ2014 delays the time for cancer regrowth (time to progression) compared to everolimus.

Targeted Hypoglossal Neurostimulation Study #2 (THN2)

The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).

Study of [11C]DPA-713 for Temporal Lobe Epilepsy

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.

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

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.

Intensity-modulated Radiotherapy for Locally Advanced Cervical Cancer (DEPICT)

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.

Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)

The primary objective of this study is to assess the number of patients preferring the methotrexate pre-filled pen to the methotrexate pre-filled syringe after 6 weeks of treatment based on a questionnaire

Ultrasound by Nurses in Heart Failure Patients

Cross-over study aimed to study the diagnostic and clinical impact of routinely adding a pocket-size ultrasound examination to traditional care at a outpatient heart failure clinic.

Observational, Non-interventional, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients (TREMODI)

Observational, Non-interventional, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients (TREMODI)

Circular Cyclocoagulation Using HIFU With EYEOP1 Device in Glaucoma Patients

The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients

EEG and Pharmacological Exploration of Executive Dysfunctions Induced by STN-DBS in PD (EEGDBSNAd)

Deep brain stimulation (DBS) of the subthalamic nucleus (STN) remarkably improves motor functions in patients with Parkinson disease (PD). However, growing evidence suggests that STN-DBS also causes executive inhibitory deficits and impulsive behaviour (Jahanshahi et al 2000; Schroeder et al 2002; Hershey et al 2004; Thobois et al 2007; Frank et al 2007; Ballanger et al., 2009). Despite a widespread use, the mechanisms of action of STN-DBS are still unclear. Two reasons might explain this. 1) From a theoretical point of view, cognitive models of executive control mechanisms are incomplete. 2) From a methodological point of view, investigating cerebral activity during STN-DBS is very limited because most techniques are incompatible with locally implanted electrodes. This project relies on a double opportunity to answer these questions offered by recent theoretical and methodological advances. First, investigations in healthy subjects (Jaffard et al 2007, 2008, Boulinguez et al 2009) revealed an essential function of inhibitory control, so far ignored, consisting in locking in advance movement triggering processes to prevent undesired automatic or anticipated responses to unattended stimuli. In other words, key processes of executive control may act tonically before stimulation occurs, calling brain imaging studies to look at proactive and not only reactive activations. Second, recent advances in EEG signal processing now allow suppressing from the electroencephalogram DBS-related artifacts (Allen et al. 2010), providing a tremendous opportunity to use a non-invasive technique with the high temporal resolution necessary to disentangle proactive from reactive brain activity. To our knowledge, up to date no study has been published using EEG with STN-DBS patients since Allen et al.'s paper. The first operational purpose of this project is to identify the anatomo-functional origin of STN-DBS-induced executive dysfunction using EEG recordings in classical stimulus-response tasks. Results expected from this first part of the project may help resolving other long-lasting issues. Indeed, reactivity as assessed by simple reaction time in non-implanted patients as well as impulsivity in STN-DBS patients are known to remain insensitive to dopaminergic medication. Since the proactive activity related to executive, inhibitory, control may be supported by the noradrenergic (NA) system, the second purpose of this project is to test the original hypothesis according to which NA plays a central role in both akinesia and STN-DBS side effects.

A Trial of AZD4547 for Breast Cancer That is Oestrogen Receptor Positive and Has Got Worse Despite Having Anastrozole or Letrozole (RADICAL)

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.

GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation

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.

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

To evaluate the impact of immunosuppressive drugs on the vaccination response in patients with Crohn's disease

Eltrombopag in Patients With Delayed Post Transplant Thrombocytopenia. (ITP0511)

This is a Phase II multicentre study. Patients will be administered eltrombopag 50 mg/daily. If patients don't achieve response after 2 months of therapy they will stop eltrombopag; if patients will achieve response after 2 months of therapy, they will continue eltrombopag for a maximum period of 24 months; 40 patients are needed. In stage I, 22 patients will be enrolled; if ≤ 4 responses at the first evaluation after 2 months (18%) will be seen, the trial will be stopped; if 5 or more responses will be seen, the accrual will continue. In stage II, 18 more patients will be enrolled. If ≤ 12 (30%) responses will be observed out of 40 patients, it will be concluded that the study drug is not active enough. If ≥ 13 responses will be observed, it will be concluded that eltrombopag is worth of further studies.

Role of Mesocorticolimbic Pathway in Apathy of Patients With Parkinson's Disease. - Study Using Diffusion Tensor Imaging and Fibres Tracking

The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods

A Phase 4 Study to Assess the Impact of Patient Support Program on Health Related Quality of Life and Adherence in Subjects With Relapsing-Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart™ Device (RebiQoL)

This is a randomized, comparative, and multicenter study to assess the impact of a patient support program (MinSupport Plus) on health related quality of life (HRQoL) and adherence in subjects with relapsing-remitting multiple sclerosis administered Rebif® with the RebiSmart™ device.

Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta. (MSREPAIR)

This is a 24-week phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter safety study comparing the tolerance profile of olesoxime (495 mg, od) when administered on top of Interferon beta in patients with stable Relapsing Remitting Multiple Sclerosis. Patients will be randomly allocated to olesoxime (495 mg, od) or placebo in a 1:1 ratio.

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

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.

The More & Less Study: A Trial Testing Different Treatment Approaches to Obesity in Preschoolers (M&L)

Obesity has been shown to be resistant to treatment in adults, adolescents, and in school age children, but not during early childhood. Yet knowledge on the effectiveness of early childhood treatment programs for obesity is still very limited, preventing the widespread implementation of such programs. The overarching purpose of this study is to evaluate the effectiveness of early treatment of childhood obesity. The investigators plan to perform a carefully-designed randomized controlled trial that will evaluate different treatment options offered to families with children with obesity, organized within the healthcare system and followed up for at least 1 year post-baseline. Participants will be children aged 4-6 years (N=180) with obesity and their parents. This study will facilitate a close examination of key treatment components and mechanisms of change. Results from this study will lead to better healthcare options for obesity treatment during childhood and ultimately to the prevention of obesity later in life from a public health perspective.

Correlation of Orbital Cerebrospinal Fluid Pressure and Retinal Venous Outflow in Primary Open-angle Glaucoma

A spontaneous venous pulsation over the optic disc is an ophthalmological sign that can potentially be found in up to 98% of healthy individuals. In fact, the lack of this spontaneous retinal venous pulse has been consistently implicated as an indicator of a more advanced form of certain ocular diseases, specifically open-angle glaucoma. However, the mechanisms behind these change in the retinal venous system are not clear. Some evidence suggests that extraocular features such as intracranial pressure (ICP) may play a role in regulating the intraocular venous outflow. The reasons for this hypothetical downstream resistance to venous outflow are not fully understood, with advances in this field being limited by our technological-imposed difficulties in assessing the structures behind the globe. However, it has been established that the volume of cerebrospinal fluid surrounding the optic nerve correlates with the ICP at the orbital level. Recent studies have suggested that non-invasive ultrasound-based recordings have correlated this surrogate for orbital ICP with the intraocular pressure (IOP) in glaucoma patients with an otherwise normal IOP range (normal tension glaucoma - NTG). The investigators will therefore conduct a test to determine if this cerebrospinal volume surrounding the optic nerve correlates with the frequency of observation of an otherwise signal of venous dysfunction (i.e. the lack of a visible pulse in the retinal central vein) Additionally, the investigators will assess if this correlation is different between healthy individuals, hypertensive primary-open angle glaucoma or NTG patients.

Study on the Oxygen Saturation in Pulsating and Non-pulsating Central Retinal Veins

Retinal ischemia is thought to play an important role in the pathogenesis of glaucoma. Recent findings have confirmed that there is a direct correlation between the levels of venous oxygen saturation and the degree of the glaucomatous disease, presumably due to a decrease in retinal cell metabolism. However, glaucoma patients have been suggested to have a different pattern in retinal venous circulation. For instance, the observation of a visible pulsating central retinal vein is a phenomenon that can be seen in up to 98% of the healthy individuals but is identifiable in less than 50% of glaucoma patients. While the nature of these venous changes are not year clear, the lack of a visible pulsating flow could suggest an increased intraluminal venous pressure due to some obstruction from both ocular or extraocular structures. This undetermined increase in venous pulse pressure could then significantly decrease perfusion pressures and therefore further decrease oxygen supply to the retinal tissues. The investigators will therefore try to determine if there is a significant difference between the oxygen saturation of the retinal vessels in both glaucoma patients with and without a visible pulsating central vein

STELLA Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer

The purpose of this study is to determine whether the extraperitoneal approach is better than the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer.

A phase II, randomized study of paclitaxel with gdc-0941 versus paclitaxel with placebo in patients with locally recurrent or metastatic breast cancer

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

Predicting Outcome in Cervix Carcinoma: a Prospective Study (POCER)

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.

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

Assess the effect of i.v. infusion of BYM338 on muscle volume of the thigh (assessed by MRI) compared to placebo

ARMONIA: An Observational Study of Biologic Drugs in Monotherapy or Combination With DMARDs in Italian Clinical Practice and the Efficacy and Safety of RoActemra/Actemra (Tocilizumab) Monotherapy in Patients With Rheumatoid Arthritis

This is a multicenter observational study in patients with rheumatoid arthritis in routine clinical practice in Italy. In the retrospective Part 1 of the study, clinical and demographic factors associated with the use of a biologic drug in monotherapy as compared to therapy in combination with DMARDs will be evaluated. In the retrospective/prospective Part 2 of the study, efficacy and safety of the use of RoActemra/Actemra (tocilizumab) in monotherapy will be evaluated. Patients will be followed for up to18 months.

A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects

The primary objectives of this study are: • To determine the efficacy of treatment with SOF + RBV as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR12) • To evaluate the safety and tolerability of SOF + RBV as assessed by review of the accumulated safety data, including HIV-RNA and CD4 T-cell percent

A Phase I Trial of AZD3965 in Patients With Advanced Cancer

The main aims of this clinical study are to find out the maximum dose that can be given safely to patients, the potential side effects of the drug and how they can be managed and what happens to AZD3965 inside the body.

The NEMO trial (NRAS melanoma and MEK inhibitor): A randomized Phase III, open label, multicenter, two-arm study comparing MEK162 versus dacarbazine in patients with advanced unresectable or metastatic NRAS mutation-positive melanoma

To determine whether treatment with MEK162 prolongs PFS as compared to dacarbazine in patients with advanced unresectable, or metastatic NRAS mutation-positive melanoma who are previously untreated or who have progressed on or after prior first-line immunotherapy for metastatic disease.

An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer (GERTAC)

This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in first-line therapy in patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer. Eligible patients, for whom the treating physician has decided to initiate treatment with Tarceva according to the local label will be followed for 18 months.

Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV)

This is a multicentric international phase III, double blind randomized study assessing efficacy and safety in parallel group of BF2.649 (pitolisant) compared to placebo in add-on to sodium oxybate of narcoleptic patients with residual Excessive Daytime Sleepiness (EDS) during 8 weeks

Evaluation of the Efficacy of Platelets Treated With Pathogen Inactivation Process (EFFIPAP)

This study is a multicentre, double-blind, randomized therapeutic trial. The primary objective of this study is to evaluate non-inferiority with regard to prevention and control of haemorrhage: - of platelet concentrates treated by pathogen inactivation (Intercept amotosalen and UVA procedure) - compared with the usual platelet concentrates (in additive solution intersol), reference arm, and - compared with platelet concentrates re-suspended in autologous plasma (historic arm) These three products are available and authorised by ANSM (formerly AFSSAPS). The secondary objectives is to evaluate the transfusion needs, transfusion outcomes and safety and the decreased frequency of grade 2 or higher side effects related to transfusion allergy to platelets.

A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of Liraglutide in Obese Adolescent Subjects Aged 12 to 17 Years

This trial is conducted in Europe. The purpose of the trial is to assess safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of liraglutide in obese adolescent subjects aged 12 to 17 years.

Nintedanib(BIBF1120) in Thyroid Cancer

Angiogenesis pathway represents a set of potential targets for targeted therapies in thyroid cancer. VEGF receptors (VEGFR) and especially VEGFR-2 is considered to be the crucial receptor involved in initiation of the formation as well as the maintenance of tumor vasculature. Vascular endothelial growth factor (VEGF) and VEGF receptors (VEGFR-1, VEGFR-2) as well as receptors of the fibroblast growth factor (FGF) and for the platelet-derived growth factor (PDGF) are often overexpressed in thyroid cancer. These receptors are also expressed on perivascular cells, such as pericytes and smooth muscle cells, that are also involved in tumor angiogenesis. Tyrosine kinase inhibitors of the VEGFR or PDGFR pathway have been tested in thyroid cancer with positive results. Vandetanib is approved for MTC and it is expected soon that sorafenib will be approved for differentiated thyroid cancer. The treatment options for patients with DTC and MTC who have progressed on one line of therapy are limited and there is no treatment that is generally considered as standard of care. No clinically meaningful benefit has yet been demonstrated with cytotoxic chemotherapy. On the other hand patients are still in good general condition and may still benefit from treatment and experience survival prolongation. Nintedanib is a triple angiogenesis inhibitor which inhibits receptors of VEGF, FGF and PDGF therefore acting potentially not only on endothelial cells but also on pericytes and smooth muscle cells. Nintedanib also interacts with other kinases such as RET. Because of its multi-kinase activity rationale exists to develop it in both MTC and DTC. By targeting these three major angiogenesis signaling pathways it is believed that nintedanib can prevent further tumor growth and related tumor escape mechanisms. This also means that nintedanib may be active in patients who have progressed on agents that target only one pathway.

Effect of ivabradine versus placebo on cardiac function, exercise capacity, and neuroendocrine activation in patients with Chronic Heart Failure with Preserved left ventricular Ejection Fraction An 8-month, randomised double-blind, placebo controlled, international, multicentre study.

To assess the effect of ivabradine compared to placebo on the diastolic function, the exercise capacity and the neuroendocrine activation over an 8-month treatment period.

Gut-derived Neuropeptides in Cerebrospinal Fluid of Patients With Parkinson's Disease and Healthy Controls

Collection of CSF and serum samples in a standardized way in order to quantitatively measure the concentration of gut-derived peptides (ghrelin, leptin, glucose-dependent insulinotropic peptide [GIP], GLP-1, amylin, PP, peptide YY [PYY], and insulin). Scientific questions: Do CSF (and serum) concentrations of these gut peptides differ between PD patients and controls? Do CSF (and serum) concentrations of the investigated peptides correlate with clinical and / or epidemiological characteristics of the investigated subjects (age, gender, BMI, disease duration, severity of motor impairments, presence of non-motor symptoms, co-morbidities, medication, etc.)?

Monitoring Natural Killer Cells in Multiple Sclerosis Patients Treated With Fingolimod

Data on fingolimod effects on NK cells are so far conflicting. A longitudinal study on fingolimod treated kidney transplant patients showed that NK cells were not influenced in any of the treatment groups. However, more recent reports indicate an increased frequency of NK cells in peripheral blood and CSF of MS patients treated with fingolimod and a relative reduction of immature CD56bright NK cells in fingolimod-treated MS patients. It has been demonstrated that the expression of NK cell relevant sphingosine 1-phosphate (S1P) receptors seems to increase during NK cell maturation. Thus, different NK cell sub-types may response differently to S1P-receptor agonist such as fingolimod. Therefore, the investigators aim to investigate longitudinally (baseline vs. treatment) the effects of fingolimod on NK cell maturation/differentiation.

A Phase IIa, Open-Label, Multicenter Study of Single-Agent MOR00208, an Fc-Optimized Anti-CD19 Antibody, in Patients with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma

To assess the antitumor activity of single-agent MOR00208 in adult patients with relapsed or refractory NHL who have received at least one prior therapy containing rituximab as one of the treatments.

A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer. (UV1-hTERT2012L)

In this study, up to 21 patients with lung cancer will receive UV1 (a therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability of UV1 as well as immunological response will be assessed. The purpose of this study is to select a biological dose of peptides for further clinical trials.

Feasibility Study Of Identification Of Sentinel Node(s) In Breast Cancer (SENTIMAG)

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

BOVARI: A Non-Interventional Study of Avastin (Bevacizumab) as Front-Line Treatment in Patients With Ovarian Cancer

This non-interventional study will evaluate the routine use and the safety and efficacy of Avastin (bevacizumab) as first-line treatment in patients with advanced ovarian cancer (epithelial ovarian cancer, fallopian tube carcinoma, primary peritoneal carcinoma). Newly diagnosed patients who are initiated on carboplatin/paclitaxel chemotherapy in combination with Avastin will be followed for up to 15 months of treatment and 12 months of follow-up.

Safety and Efficacy of Irreversible Electroporation in Ablation of Prostate Cancer in Humans

Up to 16 patients with confirmed low- or intermediate risk prostate cancer scheduled for a radical prostatectomy will be asked to have the Irreversible Electroporation (IRE) procedure approximately 30 days prior to the prostatectomy. Ablation with IRE will be performed using similar planning criteria, procedure protocol, instruments and software used for brachytherapy, a conventional targeted radiation therapy where radioactive seeds are implanted into prostate tumours. Patients will have an ultrasound of the prostate and the imaging data will be entered into the Planning Software system. The volume of the prostate is measured and a specified ablation zone will be determined. The IRE will be performed under general anaesthetic and the specified zone identified in the planning stage will be ablated. Four IRE electrode needles will be placed into the prostate under ultrasound image guidance. When the needles are in place, electric pulses of one to two minutes duration are used to ablate the specified zone. The total procedure time will be approximately 1 hour. Safety data will be collected and patients will be followed up at 1 week, 2 weeks post IRE, pre- prostatectomy, post prostatectomy and 1 week post prostatectomy. The safety data collection is at 2 weeks post IRE. Before the IRE procedure, patients will have a Magnetic Resonance Imaging (MRI) and Contrast Enhanced Ultrasound (CEUS) of the prostate. The patients will have their scheduled prostatectomy at approximately 30 days after the IRE procedure. Pre-prostatectomy, the ablation zone will be radiologically assessed by a control MRI/CEUS. Post prostatectomy, efficacy of ablation will be determined by histological examination of the prostate by the Pathology Department and measured as complete or incomplete ablation. The primary outcome is safety as measured by the composite of procedural device and post procedural adverse events, measured with the Common Terminology Criteria for Adverse Events v 4 (CTCAE), Expanded Prostate Cancer Index Composite (EPIC) score, International Prostate Symptom Score (IPSS) or required catheterization time and International Index of Erectile Function (IIEF) and efficacy of ablation determined by histological examination post prostatectomy. Secondary outcomes will be patients procedure satisfaction measured by patient satisfaction questionnaire, post procedural pain management and Visual Analogue Scale (VAS) pain score, time to ambulation, length of hospital stay.

Trial of RNActive®-Derived Prostate Cancer Vaccine in Metastatic Castrate-refractory Prostate Cancer

The purpose of this study is to determine whether the new RNActive-derived prostate cancer vaccine CV9104 prolongs survival in patients with asymptomatic or minimally symptomatic metastatic prostate cancer that is castrate resistant.

TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)

The ACHIEVE study is a single-arm, open-label, prospective, post-market follow-up study to be conducted on fifty (50) eligible patients with a twelve month follow-up period.

Aspirin Resistance and Sleep Apnea (AREAS)

The main objective of our study is to analyze the influence of sleep apnea on the response to antiplatelet therapy in stable aspirin-treated type-2 diabetes patients.

A phase IV, postmarketing, open-label, extension (rollover) study of vemurafenib in patients with BRAFV600 mutation−positive malignancies previously enrolled in an antecedent vemurafenib protocol

To provide continued access to vemurafenib for eligible patients with BRAFV600 mutation-positive malignancy who were previously treated for an antecedent vemurafenib protocol without meetings its definite criteria for disease progression there and may potentially benefit from continued treatment with vemurafenib

Preoperative Oral Immunonutrition for Patients With Pancreatic Cancer Undergoing Elective Surgery - Effect on Complications and Length of Hospital Stay

The purpose of this study is to investigate the effect of preoperative immunonutrition on complications and length of hospital stay in patients with pancreatic cancer undergoing elective surgery.

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

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.

Pilot Study Evaluating the Use of Simultaneous HBV, HCV, and HIV Rapid Tests (OPTISCREEN-III)

This is a pilot, monocentric, prospective, randomized control trial looking at the use of rapid tests as a part of normal care. The investigators will be testing for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Testing will be proposed to all persons seeking care at the Centre d'Accueil, de Soins et d'Orientation from the organization Médecin du Monde (CASO, MDM). Infection status of participants will be determined by either the standard test (ELISA) or rapid test. The choice between tests will be determined randomly. The overall goal is to determine the general acceptability and feasibility of rapid tests and to see if they can help individuals increase their awareness of infection status when compared to longer, routine methods of testing. In addition, results from these tests will allow the medical doctor to guide participants to appropriate care. All positive tests will be confirmed at a specialized hospital (Hôptial Saint-Antoine, Paris, France) and health-specific information will be obtained four months after testing.

Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension

This study examines the long term safety and efficacy of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan primarily at the highest dose in development) in patients with moderate to severe hypertension.

Identification, Molecular Epidemiology Angiosarcoma of the Liver France (ANGIHE)

The purpose of this study is to test the feasibility of identifying incident cases of angiosarcoma of the liver from the network NetSarc

Mainz Registry of Flow-mediated Constriction

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.

The Role of Postoperative Cycles in the Perioperative Chemotherapy for Gastric Cancer (STOPEROPCHEM)

Taking into account the substantial doubts concerning the potential benefit of postoperative part in the perioperative chemotherapy regimen we designed a study assessing value of this approach in gastric cancer. To improve compliance with a protocol regimen of this aggressive combined therapy we replaced tested in the MAGIC trial ECF regimen with more effective and better tolerable EOX chemotherapy regimen. The value of postoperative three-cycle EOX regimen will be tested in patients with locoregionally advanced gastric cancer with positive pathological response to preoperative three-cycle EOX chemotherapy regimen. The patients will be randomized to the postoperative chemotherapy or to the follow-up arm.

To Evaluate the Technique and Effects of Separating the Prostate and Rectum With Hyaluronic Acid During Radiotherapy (NoHarm)

The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the rectum could be completely moved out of the treated volume, a substantial decrease of rectal toxicity seems reasonable. In this study we will develop and evaluate a new transrectal injection technique where hyaluronic acid (HA) is injected in the space between the prostate and the rectum prior to external beam radiotherapy to increase the physical distance between prostate and rectum.

Acid-suppressing Drugs Pregnancy Asthma Offspring Study

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.

Study of Meloxicam Capsules to Treat Osteoarthritis Pain

The purpose of this study is to determine whether Meloxicam [Test] Capsules are safe and effective for the treatment of osteoarthritis pain of the knee or hip.

The Effects of RT-CGM on Glycemia and QoL in Patients With T1DM and IHA (IN CONTROL)

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.

Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System (DIRECT II)

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

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

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.

Definitive Radiochemotherapy Plus/Minus Cetuximab in Unresectable Locally Advanced Esophageal Cancer

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.

Comparison Study of Brachytherapy and Endoscopic Stenting for Dysphagia in Esophago-Gastric Junction Cancer (BRASTEGAC)

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.

RCT: Added Value of Coordinator for the Management of Hip Fracture Patients

To evaluate whether a coordinator increases the optimal management of osteoporotic fracture patients and hip fracture patients.

Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer

Patients with unresectable pancreatic cancer in most of cases cannot benefit from percutaneous ablation modalities, due to high risk of procedure-related complications. Ultrasound-guided high intensity focused ultrasound (HIFU) ablation has been introduced as a feasible treatment option in these patients. However, in other anatomical regions US-guided HIFU has been replaced by the more accurate MR-guided focused ultrasound (MRgFUS) ablation, but the applicability of this latter technique to the treatment of pancreatic cancer is still unexplored. The aim of this study is to explore feasibility and clinical performance of MRgFUS ablation of unresectable pancreatic cancer. Two are the main end-points: Pain palliation and local tumor control. As compared to conventional US-guided HIFU, MRgFUS could represent a more accurate, non-invasive ablation modality even for unresectable pancreatic cancer although, to date, no cases of pancreatic MRgFUS ablation have been reported.

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

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.

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

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.

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

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

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

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).

Bone Microarchitecture in Young Cystic Fibrosis Patients

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.

Lenalidomide, MTX, Ara-C and Rituximab in Relapsed Aggressive B-cell Lymphomas (LeMLAR)

Multicenter prospective open-label non-randomised phase I/II study in patients with relapsed or refractory CD20-positive aggressive lymphomas

Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab (IIPOP)

Treatment by association of complete surgical excision of the lesions and intraperitoneal immunotherapy using Catumaxomab for patients with gastric peritoneal carcinomatosis

First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02 (FMG-MM02)

The purpose of this study is to determinate the efficacy and safety of the 3-drug induction treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance. Primary endpoint is the immunophenotypic remission rate.During the randomized mobilization phase two active comparator arms Cyclophosphamide (CY)2g/m2 + Granylocyte-colony stimulating factor)G-CSF vrs G-CSF will be compared regarding efficacy, costs and safety.

A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC (Galaxy 2)

The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.

Parp Inhibitor in Advanced Non-Small Cell Lung Cancer (PIN)

The purpose of this clinical trial is to find out whether or not giving a drug called Olaparib following chemotherapy will benefit patients with NSCLC who have responded to initial chemotherapy treatment by prolonging the time before the tumour regrows. Olaparib is a new, oral drug developed by AstraZeneca which may help to slow down cancer growth. The rationale for this clinical trial is that chemotherapy damages tumour cell DNA and NSCLC tumours that respond to chemotherapy are less able to repair this damage. This can be exploited by using Olaparib as it blocks an enzyme called Poly (ADP-ribose) polymerase (PARP) which is essential for DNA repair. This will prevent DNA repair and cause cancer cell death by a mechanism known as synthetic lethality. Synthetic lethality arises when a combination of mutation in two or more genes leads to cell death.

A Study of the Safety and Effectiveness of Irosustat When Added to an AI in ER+ve Locally Advanced or Metastatic Breast Cancer. (IRIS)

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.

NEPTUNE: A Randomised Phase II Study of Neoadjuvant TAK-700 and Leuprorelin Acetate versus Surgery Alone in Intermediate and High Risk Clinically Localized Prostate Cancer

To investigate if neoadjuvant TAK-700 with LHRH agonists and prostatectomy is associated with a delay in progression- free survival compared to prostatectomy alone. The primary endpoint will assess the 3 year biochemical progression free survival (PSA)

Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer (ARAFOR)

A study to investigate which of two different tablet formulations of ODM-201 is best suited for use in the further development of the compound in the treatment of metastatic chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the bioavailability study will be able to receive further treatment with the current capsule formulation of ODM-201 until progression of their disease with the safety and tolerability of ODM-201 being assessed throughout.

To Compare the Pharmacokinetics of Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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.

Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (EAS)

The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.

The Swedish Trial of Isolated Hepatic Perfusion for Uveal Melanoma Liver Metastases (SCANDIUM)

A randomized controlled, open-label, multi-centre study evaluating if Isolated Hepatic Perfusion (IHP) increases Overall Survival compared with Best Alternative Care (BAC) in patients with isolated liver metastases from uveal melanoma.

iCBT for Depression - Standard Versus Condensed Treatment Material (KONRAD)

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.

Micropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm)

This study will investigate if micropulse laser trabeculoplasty (532nm) is as effecttive as or better than the conventional laser trabeculoplasty (532nm), it might be a new treatment strategy for glaucoma patients. It is done with a laser device that can also be used for many other ophthalmic applications, thus reducing the economic burden of treatment.

Feasibility of Microdialysis (MTM COLON I)

The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery.

Increasing Exercise Capacity of Patients With Heart Failure by Wii Gaming (HF-Wii)

The study objectives are to determine the effectiveness of structured access to a Wii game computer compared to motivational support only in heart failure patients on exercise capacity and daily activity. Secondly, to determine the effectiveness of structured access to a Wii game computer compared to motivational support only in heart failure patients on the combined endpoint of death, readmission and quality of life.

An Observational Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer

This observational study will evaluate the impact of rash on survival of patients with metastatic pancreatic cancer treated with Tarceva (erlotinib) plus gemcitabine. Further, clinical effectiveness, efficacy and safety will be assessed. Data will be collected for 12 months.

A Dose Ranging Study to Evaluate the Safety and Efficacy of GSK2586184 in Patients With Chronic Plaque Psoriasis

A multi-centre, randomised, dose ranging study to evaluate the safety and clinical efficacy of GSK2586184 in patients with chronic plaque psoriasis. There will be 2 study cohorts (Cohorts A and B). Cohort A is the main study cohort, and this part of the study will be randomised, double-blind and placebo-controlled. Fifty-six subjects will be randomised in Cohort A: 14 subjects in each treatment group: 100 mg, 200 mg or 400 mg GSK2586184, or placebo. Cohort B is an exploratory, open-label investigation of the effect of 400 mg GSK2586184 on inflammatory gene expression in the skin and whole blood, and GSK2586184 concentrations in the skin. A maximum of 8 subjects will be included, and all subjects will take 400 mg GSK2586184.

Immunization With Plasmodium Falciparum Sporozoites Under Chloroquine or Chloroquine/Azithromycin Prophylaxis (MMV)

This study will assess the superior protective immunity of the combination of chloroquine and azithromycin prophylaxis under Chemoprophylaxis Sporozoites (CPS) immunization versus a standard chloroquine prophylactic regimen.

Randomized Comparison of Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity

Bariatric surgery is the most effective treatment for morbid obesity. Roux-en-Y gastric bypass (RYGB) is a bariatric procedure with known safety and effectiveness. Laparoscopic sleeve gastrectomy (LSG) is a newer procedure gaining popularity. The aim of the study is to compare outcomes of these two surgical methods in terms of weight loss, improvement of common comorbidities of obesity and influence on metabolic and hormonal status.

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

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)

Antibiotics and Hydroxychloroquine in Crohn's

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.

Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic Fibrosis

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.

Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart Failure

The primary aim of the study is to determine safety, tolerability and feasibility of bilateral carotid body resection in patients with systolic heart failure and peripheral chemoreceptor hypersensitivity. The secondary aim is to assess potential efficacy of bilateral carotid body resection.

Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate (SERUM)

The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or adalimumab plus methotrexate. This comparison will be performed for all subjects and separately for subjects who are anti-drug antibody positive for one of these medications. From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of etanercept in these subjects will also be evaluated throughout the study.

Interventional, open-label, flexible-dose extension study of brexpiprazole in patients with schizophrenia

The primary objective is to evaluate long-term safety and tolerability of brexpiprazole

A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the combination regimen of MK-5172 and MK-8742 +/-Ribavirin (RBV) in Subjects with Chronic Hepatitis C Virus Infection

In treatment naïve (TN) subjects with chronic HCV GT 1 infection with pre-treatment HCV RNA of at least 10,000 IU/mL: (1)To evaluate the efficacy of each treatment arm of MK-5172 in combination with MK-8742 +/- RBV as assessed by the proportion of subjects achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy). (2)To evaluate the relative safety and tolerability of MK-5172 in combination with MK-8742 +/- RBV.

Study on the Clinical Course Of Pulmonary Embolism (SCOPE)

The course of both pulmonary embolism (PE) and one of its more relevant late complications, i.e. chronic thromboembolic pulmonary hypertension (CTEPH) is still substantially unknown. Recent evidence has shown that the incidence of CTEPH is higher than previously believed, but this has not been confirmed by other studies. A clear link between PE and CTEPH has been questioned by some experts. A great number of patients affected by PE persistently have residual chronic thromboembolic material the meaning of which is a matter of debate. The evidence sustaining a link between chronic residual PE and subsequent PE recurrences or CTEPH is insufficient. Thus, a nationwide, multicentre, prospective cohort study was designed with the following aims: - to ascertain the actual incidence of symptomatic CTEPH after a first episode of acute PE; - to ascertain the actual incidence of venous thromboembolic (VTE) recurrences after a first episode of acute PE; - to evaluate whether a relation exists between chronic residual PE and CTEPH - to evaluate whether a relation exists between chronic residual PE and VTE recurrences; - to evaluate whether a relation exists between persistent right ventricular dysfunction and CTEPH; - to evaluate whether a relation exists between persistent right ventricular dysfunction and PE recurrences. For each enrolling centre, consecutive outpatients or inpatients with an objectively diagnosed first acute PE episode are considered eligible.

Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients (ENESTFreedom)

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

Validation of Myocardial Perfusion Imaging (CameraCZT)

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.

Drug-Eluting Balloon in Stable and Unstable Angina (DEBUT)

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.

Impact Of Closure Of Patent Foramen Ovale On Apnoea-Hypopnoea-Index, Nocturnal Hypoxemia And Systemic Vascular Function In Patients With Obstructive Sleep Apnoea

The purpose of this study in patients with obstructive sleep apnoea (OSA) and concomitant patent foramen ovale (PFO) is to assess the impact of percutaneous PFO closure on nocturnal hypoxemia and apnea/hypopnea, pulmonary and systemic artery pressure, endothelial function and arterial stiffness.

Safety and Efficacy of Radiotherapy Combined With a 6-month LH-RH Agonist and Abiraterone Hormone Therapy Treatment in Biochemically-relapsing Prostate Cancer Following Surgery (CARLHA)

As there is no prospective data on the combination of abiraterone and salvage radiotherapy, the aim of this study is to further evaluate the safety profile of abiraterone acetate plus prednisone in patients with prostate cancer who are biochemically relapsing after surgery and undergo salvage radiotherapy with 6-months LH-RH agonist. The investigators hypothesize that the toxicity profile of both treatments should not potentiate each other. This study will also provide preliminary data on the efficacy of this combination.

A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) versus Docetaxel in Previously Treated Subjects with Squamous Histology Non-Small Cell Lung Cancer

The main objectives of this study are: - to compare the overall survival of previously treated subjects with squamous non-small cell lung cancer treated with MK3475 compared to docetaxel. - to compare overall response rate as determined by immunerelated response criteria of previously treated subjects with squamous non-small cell lung cancer treated with MK3475 compared to docetaxel. - Evaluate safety and tolerability profile of MK3475 in previously treated subjects with squamous non-small cell lung cancer

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

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.

The Impact Of Periodontal Disease Treatment On The General Health Status In Chronic Haemodialyzed Patients (PAROHEM)

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).

Physiological Effects of Altering Cancer-related Inflammation

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.

Evaluation of an Osteoporosis Prevention Strategy in Women With Osteoporotic Fracture of the Upper Limb (PREVOST)

The aim of the PREVOST program is to assess the efficiency of patient-centered osteoporosis prevention program, after a fragility fracture of the upper limb, to improve post-fracture management of osteoporosis (ie BMD test and / or osteoporosis treatment) in women over 50 years old. This open randomized controlled trial aims to compare the BMD or osteoporosis treatment prescription rate at 6 months after inclusion between two groups: "intervention" receiving information on fracture and osteoporosis (oral and written), phone call reminders and written information to give to their family physician, and "control" receiving usual care without information.

Very early FDG-PET/CT-response adapted therapy for advanced stage Hodgkin Lymphoma, a randomized phase III non-inferiority study of the EORTC Lymphoma Group.

The main objective of the trial is to show that ABVD-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification in case of a positive FDG-PET/CT after one cycle of ABVD, has non-inferior efficacy compared with the intensive BEACOPPesc regimen.

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

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

Atrial Fibrillation/Sinus Rhythm Before and After Cardioversion

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

Emollients in the Management of Atopic Dermatitis

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.

Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)

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.

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

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

Shared Care Follow-up After Chemotherapy for Testicular Cancer (SCFU-TC)

The aim of this study is to develop and evaluate a shared care survivorship care plan (SCP) to follow-up patients with metastatic testicular cancer after completion of chemotherapy that resulted in complete remission.

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

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

Circulating Exosomes As Potential Prognostic And Predictive Biomarkers In Advanced Gastric Cancer Patients ("EXO-PPP Study")

Exosomes are formed by inward budding of late endosomes, producing multivesicular bodies (MVBs), and are released into the environment by fusion of the MVBs with the plasma membrane. It has been demonstrated that the content and function of exosomes depends on the originating cell and the conditions under which they are produced. Tumor exosome production, transfer and education of bone marrow cells supports tumor growth and metastasis. In this prospective translational study, preclinical and clinical phases have been designed. On the first step, the main goal is to characterize the molecular profile of gastric cancer derived exosomes. This exosome biosignature may provide a useful diagnostic tool. As a second step, the study will evaluate the prognostic and predictive value of gastric cancer exosomes levels in plasma and kinetics in a prospectively recruited cohort of advanced gastric cancer patients during first-line chemotherapy.

Whole Body MRI Imaging in Multiple Myeloma at 3 Tesla MRI : Added Value of Diffusion Weighted Imaging

Whole body MRI with diffusion weighted imaging is a useful imaging tool - staging and diagnosis - therapy monitoring All patients will be scanned before and during treatment. The findings on diffusion weighted imaging will be correlated to the golden standard (computer tomography and MRI (T1 and STIR)).

Circulating Exosomes As Potential Prognostic And Predictive Biomarkers In Advanced Gastric Cancer Patients ("EXO-PPP Study")

Exosomes are formed by inward budding of late endosomes, producing multivesicular bodies (MVBs), and are released into the environment by fusion of the MVBs with the plasma membrane. It has been demonstrated that the content and function of exosomes depends on the originating cell and the conditions under which they are produced. Tumor exosome production, transfer and education of bone marrow cells supports tumor growth and metastasis. In this prospective translational study, a preclinical and a clinical phase are designed. As a first step, the main goal is to define the characteristic molecular profile of gastric cancer derived exosomes. This exosome biosignature may provide a useful diagnostic tool. As a second step, the study will evaluate the prognostic and predictive value of gastric cancer exosomes plasma levels and kinetics in a prospectively recruited cohort of advanced gastric cancer patients during first-line chemotherapy.

A 26-week, Multicenter, Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients with Schizophrenia

The primary objective of this open-label trial is to evaluate the safety and tolerability of aripiprazole intramuscular (IM) depot administered for 26 weeks to subjects with schizophrenia.

A Study of PCI-32765 (Ibrutinib) in Patients With Refractory Follicular Lymphoma

The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL).

Early Care After Discharge of HF Patients (ECAD-HF)

After decompensated heart failure, a number of patients have high risk of early rehospitalization as well as death. Specialized medical management for a short period but very early after discharge could be critical for optimizing care and improving early outcome. This study aims to compare such early intensive medical management with usual care in high-risk patients after discharge.

Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy

The primary objective of this crossover trial is to compare the 3-month, mean 24-hour intraocular pressure (IOP) control and safety obtained with two popular fixed combinations in glaucoma patients insufficiently controlled with latanoprost monotherapy. This study will compare the 24-hour efficacy of travoprost/timolol fixed combination without benzalkonium chloride given once in the evening, versus the latanoprost/timolol fixed combination given in the evening. It is assumed that travoprost/timolol fixed combination will provide better quality of 24-hour pressure control.

Impact of Incision Size and Architecture on Wound Stability and Astigmatism in Cataract Surgery: an Exploratory Study (INCISIONS)

One aim of the study is to assess the influence of the intra-operative wound architecture using a similar grading system as used by Calladine and Packard (2007)7 on the resistance to deformation of the wound and the surgically induced astigmatism in MICS and small incision cataract surgery (SICS). In a second part of this exploratory study the effect of a hinged incision with a pre-cut should be assessed along the same line

Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer (ADAPT)

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.

Efficacy and Safety of Cabazitaxel Versus Weekly Paclitaxel as Neo-adjuvant Treatment in Patients With Triple Negative or Luminal B/HER2 Normal BC (GENEVIEVE)

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.

Melatonin Dose-effect Relation in Childhood Autism (MELADOSE)

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.

Closing the Loop in Children and Adolescents With Type 1 Diabetes in the Home Setting (APCam08)

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).

Assessment of Hearts Deemed Unsuitable for Transplant With the Aim of Expanding the Donor Heart Pool.

The main question to be asked in this study is what is the potential for human hearts that have been deemed unacceptable for transplant, to be explanted and re-animated in a controlled, external environment to be assessed? Furthermore would the reanimated hearts be able to undergo improvement in their function in this external environment. Ultimately this may lead to an increase the number of hearts available for transplantation.

Standard Clopidogrel Versus Prasugrel Low Dose Therapy in Elderly Patients With Acute Coronary Syndrome (RESET ELDERLY)

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.

Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy (SME)

Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over 2 years following SCS implant. This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for SCS in approved indication in France.

Subcutaneous Stimulation as Add on Therapy to Spinal Cord Stimulation (SCS) to Treat Low Back Pain in Failed Back Surgery Syndrome (FBSS) (SubQ Study)

Aim of the study Failed back surgery syndrome (FBSS) is a clinical entity consisting of chronic leg and /or back pain due to radicular nerve damage. The effectiveness of Spinal Cord Stimulation (SCS) in the pain management of patients with FBSS is proven. Patients mostly have dominant leg pain, however a significant percentage of FBSS patients has a more pronounced back pain and are commonly excluded from SCS as it is often inadequate in relieving both the back and leg pain components. Recently some reports showed the benefit of subcutaneous stimulation (SubQ) for low back pain in patients with FBSS. This has been confirmed by a feasibility study performed by our group. The aim of the randomized controlled study is to evaluate the effect of SubQ on low back pain in FBSS patients for whom SCS gives an inadequate back pain relief.

A phase Ib/II open-label, multi-center study of the combination of BYL719 plus AMG 479 (ganitumab) in adult patients with selected advanced solid tumors

Phase IB To estimate the maximum tolerated dose MTD(s) and/or identify the recommended phase II dose(s) of BYL719 in combination with AMG 479 (ganitumab) in selected patients with solid tumors Phase II To estimate the antitumor activity of BYL719 in combination with AMG 479 (ganitumab) in the following Phase II populations: Arm 1: Patients with PIK3CA mutated or amplified hormone receptor positive breast cancer Arm 2: Patients with PIK3CA mutated or amplified ovarian cancer

An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (Koralle)

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.

Fructose and Fructans in IBS (FABS)

The purpose of the study is to investigate if patients with Irritable Bowel Syndrome (IBS) who also report bloating are more likely to report clinically important gastrointestinal symptoms after consuming fructose or fructans than after consuming glucose. We will also use MRI imaging to investigate the mechanisms by which those symptoms might be caused.

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

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.

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

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

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

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.

Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes

This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.

A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer (UV1/hTERT2012P)

In this study, up to 21 patients with metastatic prostate cancer will receive UV1 (a therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability of UV1 as well as immunological response will be assessed. The purpose of this study is to select a biological dose of peptides for further clinical trials.

Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis (TRANSFIGURE)

To demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess long-term efficacy, safety and tolerability of secukinumab.

Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis (GESTURE)

To demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess long term efficacy, safety and tolerability of secukinumab.

An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (Koralle)

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.

Safety and Efficacy of LEE011 and LGX818 in Patients With BRAF Mutant Melanoma.

To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered orally to patients with BRAF mutant melanoma.

Kinematics of Obese Patients Perambulation (MARCHOBESE)

The aim of this study is to evaluate the consequences of sleeve gastrectomy on functional parameters of patients perambulation.

Randomised Phase II Pilot Studiy: Induction Chemotherapy with Docetaxel, Cisplatin und Cetuximab versus Docetaxel, Cisplatin und 5 FU followed by Radiotherapy with Cetuximab for locally advanced or not resectable Carcinoma of the Head and Neck

Response Rate (CR, PR) 3 months after end of therapy (RECIST)

ALLPS VERSUS PVO Randomized Controlled Trial (ALPPS)

This randomized phase II trial compares how well associating liver partition with portal vein ligation for staged hepatectomy (ALPPS) or portal vein occlusion (PVO) works in treating patients with liver cancer. Both treatments are types of 2-stage hepatectomies for removing liver cancer. ALPPS may be more effective than PVO in patients whose disease would traditionally be considered inoperable.

Response of Hepatic Tumors to Radioembolization (RESRAD)

The study enrolls patients with non-resectable or borderline resectable hepatocellular carcinoma (HCC), intraheaptic choalngiocarcinoma (IHCC) or colorectal cancer metastasis. Patients are not a candidates for liver transplantation and have only limited extrahepatic disease. All patients are treated with radioembolization. Primary endpoint is the percentage of patients that can be downstaged to resectability. Secondary endpoints are radiologic response to radioembolization,tissue response to radiomembolization and systemic immune response and intra-tumoral T-cell response to radioembolization.

Sleep Apnoea Syndrome Without Chronic Heart Failure

It is the objective of this study to collect scientific data of sleep apnoea syndrome patients´ cardiac and respiratory function by additional sensors.

Intravitreal Tissue Plasminogen Activator (tPA), Perfluoropropane (C3F8), and Ranibizumab for Neovascular Age-Related Macular Degeneration and Submacular Haemorrhage (TAPAS): A Randomized, Double-Masked, Controlled, Factorial, Feasibility Study

To determine if intravitreal tissue plasminogen activator (tPA), gas (C3F8) and ranibizumab promote the resolution of submacular haemorrhage (SMH) due to neovascular (wet) age-related macular degeneration, and improve the visual outcome. The primary outcome measure will be the change in mean ETDRS visual acuity at 3 months following treatment.

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

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.

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

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.

Ext. Long-term Safety Study in CF Patients: Single Arm TIP

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.

Cytochrome P450-2D6 Screening Among Elderly Using Antidepressants (CYSCE)

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

Study of LY3016859 in Participants With Diabetic Nephropathy

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.

Biomarkers In Seizure To Predict Recurrence and Severe Outcomes (BISTRO)

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

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)

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.

A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in Treatment-Naïve Subjects with Chronic Genotype 1 HCV Infection

The primary objectives of this study are: • To determine the antiviral efficacy of combination treatment with sofosbuvir/GS-5885 fixed-dose combination ± RBV as measured by the proportion of subjects with SVR 12 weeks after discontinuation of therapy (SVR12). • To evaluate the safety and tolerability of each treatment regimen as assessed by review of the accumulated safety data

Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients (DAILY)

This prospective, non-interventional, multi-center study documents observational data on subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. The observation period for each subject covers a one year treatment period with inhaled Ventavis. For each subject, the investigator or a delegate collects data as defined in the case report form at an initial visit, routine follow-up visit at 6 months and final visit at 12 months.

Cerebral Reorganization in Schizophrenia

The purpose of this study is to reveal the specific effects of computer-aided cognitive training on cerebral reorganization in schizophrenia

Neuroplasticity-oriented Cognitive Intervention in Early Onset and First Admission Schizophrenia

The purpose of this study is to reveal the specific effects of computer-aided cognitive training on course and rehabilitation in early onset schizophrenia

Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma (RESORCE)

This clinical study evaluates the efficacy and safety of regorafenib in patients with advanced liver cancer who have progressed on sorafenib treatment.

Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer

The results of previous studies suggest further development of [18F]EF5 as a PET tracer for imaging hypoxia. This is a non-randomized prospective study to obtain information on reproducibility of [18F]EF5 intratumor distribution using repeated pretreatment PET/CT scans.

Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area

Deep brain stimulation of STN (subthalamic nucleus) at high frequencies generally improved gait in parkinsonian patients. However, sometimes the investigators observed a gait aggravation either with using high voltage and high frequencies, either because of suboptimal placement of electrode inside Forel H2 field. The most frequent hypothesise to explain this gait aggravation is a modulation of the activity of pedunculopontine nucleus due to a diffusion of the electric stimulation current to the fibbers going near STN area. The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency versus low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment).

Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients

The primary purpose of this protocol is to study the role of dopamine in the loss aversion phenomenon by comparing brain activity in parkinsonian patient with and without treatment with L Dopa, when they are exposed to mixed (gain/loss) gambles using money. The second purpose is to highlight the role of a dopamine depletion by comparing patient without treatment vs healthy paired control.

A phase II randomised, double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin in patients with moderate hepatic impairment (Child-Pugh B) with genotype 1b chronic hepatitis C infection

The objective of Cohort A is to evaluate the safety and pharmacokinetic (PK) profile of BI 207127 (potentially two doses) in combination with 120 mg once daily (q.d.) FDV and weight-based RBV in a small group of patients with moderate hepatic impairment (Child-Pugh B [CPB]) compared to patients with mild hepatic impairment (Child-Pugh A [CPA]) to define the BI 207127 dose to be used in Cohort B. The objective of Cohort B is to assess efficacy, safety, and pharmacokinetics of 24-week treatment of the BI 207127 dose selected in Cohort A in combination with 120 mg once daily (q.d.) FDV and weight –based RBV in a larger group of chronically infected HCV GT1b patients with moderate hepatic impairment (CPB).

IQP-CL-101 in IBS Management

After 2 weeks of run-in period, subjects are randomized to either IQP-CL-101 or a matching placebo. Over 8 weeks, the subjects are monitored for improvements in IBS symptoms

A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction or Gastric Cancer

This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab), fluoropyrimidine and cisplatin as first-line treatment in patients with HER2-positive metastatic gastroesophageal junction or gastric cancer. Patients will be randomized to receive Perjeta 840 mg or placebo intravenously (iv) every 3 weeks in combination with Herceptin (initial dose of 8 mg/kg iv followed by 6 mg/kg iv every 3 weeks) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Patients will continue to receive Perjeta or placebo and Herceptin until disease progression or unacceptable toxicity occurs.

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

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).

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

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.

Deep Brain Stimulation of the Superolateral Branch of the Medial Forebrain Bundle (slMFB) for the Treatment of Refractory Major Depression (FORESEEII)

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).

National Anaplastic Thyroid Cancer Tissue Bank and Database (NATT)

The primary objective of this project is to establish a national anaplastic thyroid cancer tissue collection to help facilitate both basic and translational research opportunities.

Environmental Chemicals and Their Role in Obesity (ENDORUP)

Hormonal disruption is the inappropriate alteration of the hormonal system by chemical substances that are present in our environment. Some chemical substances are capable of replicating, enhancing or reducing the production, release, transport or action of natural hormones. Therefore, they are called hormonal or endocrine disrupters. Some 'classic' endocrine disrupters such as pesticides and dioxins are considered responsible for infertility, cancer and thyroid problems. Recently, a number of additional chemical substances were stipulated to have endocrine disrupting capabilities. The industrial production of these substances in large quantities has led to an accumulation in our environment and thus possible negative consequences on human health. The aim of this study is to investigate the rol of these chemical substances in the occurence of overweight and obesity.

A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose Escalation Study to Select and Evaluate an Oral Modified Release Formulation of Omecamtiv Mecarbil in Subjects with Heart Failure and Left Ventricular Systolic Dysfunction

The aim of this study is to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in subjects with HF and left ventricular systolic dysfunction and (ii) to characterize its pharmacokinetics (PK) after 12 weeks of treatment.

A Multi-Center, Randomized, Controlled, Two-Arm, Pivotal Phase III Study to Evaluate the Safety and Efficacy of MK-3475 Compared to Ipilimumab in Patients with Advanced Melanoma

To evaluate the overall survival (OS) in patients with advanced MEL receiving either MK-3475 or IPI.

Respiratory Function and Walking Capacity in Multiple Sclerosis

Multiple sclerosis (MS) is a chronic progressive neurological disease. Respiratory dysfunction due to weakness in the respiratory musculature has been described in MS. This leads to increased morbidity and mortality in late stages of the disease. It is possible that respiratory dysfunction influence physical fitness in earlier stages as well. Walking disability and fatigue causes significant impact on health in patients with MS, even in earlier stages. The hypothesis is that there is a relationship between respiratory function, walking capacity and fatigue and that daily deep breathing exercise during two months will improve respiratory function, walking capacity and fatigue.

fMRI analysis of the visual cortex in neovascular age-related macular degeneration

To evaluate the activation pattern of the primary visual cortex in nAMD patients before and after ranibizumab therapy and to compare it with healthy controls.

Closed-loop Insulin Delivery in the General Ward (ANGIE02)

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.

Effect of Glococorticosteroids on physical performance in patients with chronic obstructive pulmonary disease and acute inflammatory response after exercise

The purpose of this trial is to investigate the effects of the drugs prednisone and Solu-Medrol on physical performance in patients with COPD

MACCE in Hospitalized Patients With Community-acquired Pneumonia

Community-acquired pneumonia is the most common infection leading to hospitalization in intensive care units and the most common cause of death associated with infection disease. Epidemiological studies have shown that respiratory tract infections are associated with an increased risk for the development of acute cardiovascular and cerebrovascular events. This link is further supported by studies indicating that influenza vaccination is associated with a reduced risk of hospitalization for pneumonia as well as heart disease and cerebrovascular disease. Data connecting acute respiratory tract infections and cardiovascular events stem almost exclusively from cross-sectional or retrospective studies. Thus the real incidence and the prognostic impact of AMI, as well as the pathophysiological relationship between pneumonia and cardiovascular damage is still elusive. Inflammation plays a major role in the pathogenesis of coronary artery disease. The increased concentrations of proinflammatory cytokines together with the activation of coagulation, the down-regulation of anticoagulant mechanisms and the enhanced platelet aggregation may trigger atheroma's instability, plaque rupture and thrombus formation. Inflammation and coagulopathy are also considered universal host responses to infection in patients with severe sepsis. Thus far limited data are available on the changes in these high regulated systems, together with platelet activity in patients with CAP and their potential relationship with cardiovascular risk. This project will consist in a prospective multicenter study to investigate the incidence of major adverse cardiac and cerebrovascular events (MACCE) in hospitalized patients with CAP, its prognostic relevance and the potential relationship between enhanced cardiovascular risk and the activation of inflammation, coagulation and platelet aggregation in this setting.

Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle

The purpose of the study is to investigate if treatment with ciprofloxacin for one week followed by therapy with E. Coli Nissle (EcN) for seven weeks can influence disease activity among ulcerative colitis patients with disease flare-ups compared to placebo controls.

Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis

This is a randomized, parallel group, placebo-controlled study designed to assess whether GSK239512 can enhance lesion remyelination in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). Subjects with RRMS on stable background treatment with either Avonex (Interferon-beta1a) or Copaxone (Glatiramer Acetate) are eligible to participate. Subjects will be randomized in a 1:1 ratio between placebo and GSK239512, and will continue to be managed with their current standard of care therapy (Copaxone or Avonex). The total treatment period is 48 weeks, including a standard 4 week titration period and 44 week maintenance treatment period (which could be adapted to a 5-week titration and 43 week maintenance period, if needed). Titration doses start at 10 micrograms (mcg) and increase up to 80 mcg (10 mcg first week, 20 mcg second week, 40 mcg third week, 80 mcg fourth week). Subjects will be titrated to the maximum tolerated dose with the objective of titrating to the highest dose (80 mcg GSK239512), whenever possible, based on investigator judgement of tolerability. The post-treatment follow-up period will be a minimum of 2 weeks in duration following the end of treatment at Week 48 or early withdrawal, as appropriate.

NSCLC Burden of Illness Study (LuCaBIS)

The aim of this observational study is to identify and quantify the humanistic and economic burden of illness of patients with complete resection (no residual disease) of stage IB-IIIA NSCLC in three European countries (France, Germany, and the United Kingdom [UK]). Data collection will be conducted through patient medical record abstraction and patient survey.

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)

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.

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

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

Laparoscopic Surgery Equivalent to Open Surgery in Right Colon Cancer Surgery? (CHIRCOL)

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

The Value of Preoperative Sentinel Lymph Node Mapping by Pelvic MR Lymphangiography and SPECT-CT in Cervical Cancer

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.

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

To assess the median survival

A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

This multicenter, open-label, single arm, long-term extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have completed the 97-week WA22762 or the 96-week NA25220 core study. Patients will receive RoActemra/Actemra 162 mg subcutaneously weekly (for patients entering from WA22762) or every two weeks (for patients entering from NA25220) for 96 weeks, with telephone call follow-up visits at Weeks 100 and 104.

The Prediction of Extent and Risk Profile of Coronary Atherosclerosis and Their Changes During Lipid-lowering Therapy Based on Non-invasive Techniques (PREDICT)

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.

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

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.

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.

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.

Intervention Study to Investigate Supplemental Oxygen in COPD

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.

A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists

To assess, in the same study, the safety of sarilumab and tocilizumab in patients with rheumatoid arthritis (RA) who are inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.

Oxford Ovarian Cancer Predict Chemotherapy Response 01 (OXO-PCR-01)

The purpose of the study is to understand why there are differences between individuals in the way they respond to paclitaxel chemotherapy.

A Study of Viral Response to Triple Therapy in Hepatitis C Virus-Infected Participants With Insulin Resistance Who Failed Dual Therapy (MK-3034-113)

This study is being done to find out if participants with insulin resistance and hepatitis C virus genotype 1 (HCV GT1) infections who failed dual therapy with peginterferon alfa (PegIFN) + ribavirin (RBV) will benefit from the addition of boceprevir to PegIFN + RBV (triple therapy).

Control and Burden of Asthma and Rhinitis (ICAR)

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)

Everolimus Beyond Progress for Patients Who Had Progress Under Everolimus and Exemestane (Evelyn)

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.

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

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

A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer (PACER)

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.

Multicenter, Open-Label, Long-Term Safety and Efficacy Study of the Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Adult Subjects with Moderate to Severe Essential Hypertension

The primary objective is to evaluate the long-term safety and tolerability of FDC of nifedipine GITS / candesartan cilexetil (primarily the highest dose) once daily in subjects with moderate to severe essential hypertension.

Training Study to Characterize Biomarkers to Flu Vaccines

It is thought that vaccines trigger innate inflammatory responses to induce antigen-specific adaptive immunity (the desired effect), but excessive inflammation may lead to serious inflammatory complications or unwanted side effects. Currently there is a lack of reliable biomarkers (a measurable biological response that predicts something) able to predict severe inflammation and this has resulted in the development of several vaccines being terminated and the withdrawal of some licensed vaccines which were associated with inflammatory complications. This study is part of the BIOVACSAFE project which is a 5-year 30 million Euro project funded by the Innovative Medicines Initiative. The project involves a series of clinical studies using licensed vaccines as benchmarks to generate clinical data on inflammation and identify biomarkers that can be used to predict acceptable reactogenicity. The target is to identify biomarkers that can predict the occurrence of beneficial and detrimental effects in response to a vaccine. Such biomarkers could be used in future vaccine development programs to optimise selection of vaccine candidates with a profile that will be unlikely to generate worrisome safety signals once they are in generalised use.

The Efficacy and Safety of Valsartan and Combination of Valsartan and Hydrochlorothiazide in the Treatment of Patients with mild to moderate Arterial Hypertension.

The aim of the study is to establish the efficacy and safety of Valsacor (valsartan) and Valsacombi (combination of valsartan and hydrochlorothiazide) in wide populations of patients with mild to moderate arterial hypertension.

A Randomized, Controlled Phase 3 Study to Evaluate Optimized Retreatment and Prolonged Therapy with Bortezomib (Velcade) in Patients with Multiple Myeloma in First or Second Relapse

The objective of this study is to explore the effect of optimized retreatment with bortezomib in combination with dexamethasone followed by prolonged therapy with bortezomib, versus standard retreatment with bortezomib in combination with dexamethasone on PFS

A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer

The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone.

A Single Centre Study to Analyze Cataract Surgery Following Femtosecond Laser-Assisted and Manual Cataract Surgery

This clinical study (non AMG/non MPG) is a contralateral, comparative, randomized, prospective, single-center, multi-surgeon, investigator masked study to investigate whether the femtolaser cataract surgery causes any significant differences in the resulting Intra Ocular Lens overlap (ΔROverlap) as compared to the conventional, manual continuous curvilinear capsulorhexis (CCC). The Intra Ocular Lens overlap (ΔROverlap) is defined as the difference between the Intra Ocular Lens center of mass to the capsulotomy aperture center of mass.

Evaluation of the Efficacy and Safety of Entelon Tab. 150mg in Patients With Osteoarthritis of Knee

This clinical trial is planned to prove Entelon tab. arm is not inferior to Celebrex cap. arm in terms of the efficacy and safety through the change of K-WOMAC's total score sum in patients with osteoarthritis of knee.

Phase 2 Efficacy Trial of OLT1177 Gel in Subjects With Moderate to Severe Pain Associated With OA of the Knee

The purpose of this trial is to investigate the efficacy and safety of OLT1177 Gel in subjects with moderate to severe pain associated with osteoarthritis of the knee following cessation of pain therapy.

Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study

This is a randomized, double blind controlled, parallel arms trial, aimed to assess the efficacy of pregabalin on pancreatic cancer induced abdominal pain. The goals of this study include (1) assessing the analgesic effect of pregabalin in comparison to placebo; assessing the presence of central sensitization and its potential reversion by Pregabalin; (3) assessing quality of life of patients treated with pregabalin in comparison to placebo; (4) to compare adverse effects in patients treated with Pregabalin in comparison to placebo; (5) to compare anxiety and depression in patients treated with pregabalin in comparison to placebo.

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.

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.

Empirical Antifungal Treatment in ICUS (EMPIRICUS)

Invasive Candida infections are burdened with a high mortality rate and is very common in intensive care units. This study aims to evaluate the efficacy of empirical treatment with micafungin in adult patients with suspected invasive candidiasis.

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

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.

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

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.

To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients

This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and Joins tablet in the treatment of osteoarthritis of the knee.

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

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.

NY-ESO-1 T Cells in OG Cancer (NY-ESO-1 OG)

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.

An open, single-centre, non-controlled feasibility study using a softwarealgorithm based insulin therapy to control blood glucose in type 1 diabetic patients

To investigate the performance of a software-algorithm based insulin therapy to control blood glucose in Type 1 diabetic patients

IOP Fluctuations in Patients With Primary Open-angle Glaucoma, Before and After Selective Laser Trabeculoplasty

Selective laser trabeculoplasty (SLT) is an increasingly popular treatment modality in early-to-moderate glaucoma patients. SLT has been suggested to reduce IOP more consistently during the nocturnal period than during the diurnal period in a group of medically-treated patients with primary open angle glaucoma (POAG). At present, there is scarce data on SLT effects on the 24-hour IOP pattern in patients with glaucoma and there is no data on the 24-hour effect of SLT in untreated glaucoma patients. The purpose of this study is to assess the changes of IOP over a 24-hour period in patients with glaucoma undergoing SLT.

Relationship Between 24-hour IOP Pattern and the 24-hour Blood Pressure Pattern in Patients With POAG

Interplay between the increasing IOP and decreasing blood pressure (BP) during the 24-hour period, especially in the nocturnal period, may lead to insufficient perfusion pressure of the optic nerve and contribute to the glaucomatous damage in adjunct to the antero-posterior vectorial mechanical impact on the lamina cribrosa, the translaminar pressure. Patients with progressive VF loss showed greater nocturnal BP dips than patients with stable VF. Reduced mean intraocular perfusion pressure (IOPP) was significantly associated with the extent of glaucomatous damage. How the nycthemeral IOP fluctuation influences glaucoma progression has not been studied in a prospective manner and remains to be elucidated. The purpose of this study is to assess the relationship between the 24-hour IOP fluctuation pattern and the 24-hour BP pattern in patients with primary open angle glaucoma (POAG). IOP fluctuations will be monitored with SENSIMED Triggerfish®, a portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.

Decoding Chronic Pain With fMRI

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.

Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients. (Pascal)

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.

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

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

MAGNITUDE - A Phase 3 Evaluation of the Safety and Efficacy of Lambda/RBV/DCV in Treatment Naïve Subjects with Chronic HCV Infection, who have Underlying Mild or Moderate Hemophilia or Patients who are Prior Relapsers to Pegylated interferon alfa/RBV Revised Protocol 01, incorporating Amendment 02 and Administartive Letter 01 + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 11-Sep-12)

To evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with GT-1b, -4 and GT-2, -3.

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

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.

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.

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).

Prognostic and Predictive Value of HE4 Biomarker in Metastatic Ovarian Cancer (Meta-Four)

HE4 is a new marker that could improve the detection of ovarian cancer. The HE4 assay may have an advantage over the CA-125 assay in that it is less frequently positive in patients with non malignant disease. Since the evaluation of HE4 for detection and diagnosis of ovarian cancer is well known, the behaviour of the marker during chemotherapy and follow-up period after treatment in metastatic ovarian cancer should be studied. It could be used in patient with non CA-125 secretary tumors. Prognosis and predictive value of HE4 should be compared with information provided by CA-125. The kinetics of HE4 values after treatment should be also analysed to determine the role that HE4 could play in the detection of recurrences during the follow-up of metastatic patients.

Prevention of depression and poor physical function in older persons with vitamin D supplementation

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?

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.

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.

Pharmacokinetics of Micafungin in Patients Intensive Care Unit (MIMIC)

In this trial, our goal is to determine the pharmacokinetics of micafungin in a non-selected cohort of patients with suspected or proven invasive fungal infections. Patients will receive micafungin for the period necessary to achieve clinical and / or mycological cure. An attempt will be made to have 2 PK curves, one full and one limited sampling on days 3 (n=9) and 7 (n=5). Furthermore, we will be able to determine intra-individual variability. On non-PK days, trough samples will be taken to determine the time to steady state. All samples will be taken just prior to the morning dose of micafungin. All infusion rates will be according to the SPC label information. Patients are considered to be evaluable if at least the first PK curve has been completed. Two moments of PK analysis will enable us to determine whether there is an increase over time in exposure if steady state has not been reached.

A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab

The study objective is to assess the long-term safety, tolerability, efficacy, and the immunogenicity of the 100 mg/mL adalimumab formulation.

Zonisamide for the Treatment of Obstructive Sleep Apnea in Overweight/Obese Patients

This RCT explores the efficacy of Zonisamide (Zonegran®)on overweight/obese in patients with moderate to severe obstructive sleep apnea. Patients will be randomized to receive zonisamide, placebo or nasal continuous positive airway pressure (nCPAP) during 4 weeks. A 5 month open extension part will follow when patients in the tablet groups will all receive zonisamide. Patients in the open CPAP group will continue with CPAP treatment. Study hypothesis: Controlled pharmacological weight reduction with Zonisamide will result in elimination of OSA and OSA sequels more effectively than nCPAP due to incomplete compliance with the mechanical treatment and a lack of direct beneficial metabolic effects after nCPAP. Further it is hypothesized that zonisamide has a direct pharmacological effect on respiratory control during sleep by its carbonic anhydrase inhibitory effects and this will result in a reduction of sleep disordered breathing.

Auricular Acupuncture and Cognitive Behavioral Therapy Treatment for Insomnia (NADA)

The aim of the study is to investigate if AA is as effective as CBT to treat insomnia for patients who have stopped using benzodiazepine-like sleep medicine.

Trial of Telephone-based Psychotherapy for Depression With and Without Adjunctive Supportive Mail (Tel-PT)

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).

Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study

Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD) and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the neuropathological bases of apathy are still unknown. However, recent data suggests that apathy could be linked to a more specific dopaminergic denervation in the ventral striatum. Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in Parkinson's disease. The primary outcome is to demonstrate a significant reduction of apathy using the Lille apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease, using a treatment by rasagiline.

Can Creatine Supplementation Improve Body Composition and Physical Function in Rheumatoid Arthritis Patients?

Rheumatoid arthritis (RA) patients typically experience a significant loss of muscle. In healthy individuals, food supplementation with creatine (Cr) increases muscle size and improves physical function and quality of life. The aim of this study is to investigate whether RA patients may benefit similarly.

Optimization of Controlled Human Malarial Infection by Injection of P. Falciparum Sporozoites in Non-Immune Adults

The study is designed to establish the best dose to safely infect healthy individuals with Plasmodium falciparum sporozoites (PfSPZ) by injection. The goal of this study is to achieve infections in human volunteers with infection rates of 100% and pre-patent periods of less than 12 days.

Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.

This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy. Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest. Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited. This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.

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

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.

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.

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

Roflumilast Plus Montelukast in Adults With Severe Asthma

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.

Phase III Study of CG100649 in Osteoarthritis Patients

6-week Efficacy Study The objective of this study is to prove the safety and non-inferiority of analgesic efficacy of CG100649 2 mg vs. celecoxib 200 mg, and analgesic superiority of CG100649 2 mg vs. placebo, when administered once a day in patients with osteoarthritis of the hip or knee over the 6 week Treatment period. The primary efficacy parameter is the difference from Baseline to Week 6 in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC)-Pain subscale. Extended Safety Study The objective of the Extended Safety Study is to collect a total of 24 weeks of safety data for CG100649 including the initial 6 weeks of safety data, and an additional 18 weeks of safety data for those subjects who agree on the consent form to continue into the Extended Safety Study. Subjects will be administered CG100649 2 mg only during 18 weeks of Extended Safety Study.

Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study

Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD) and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the neuropathological bases of apathy are still unknown. However, recent data suggests that apathy could be linked to a more specific dopaminergic denervation in the ventral striatum. Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in Parkinson's disease. The primary outcome is to demonstrate a significant reduction of apathy using the Lille apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease, using a treatment by rasagiline.

Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma (AIMM)

The objective of the present trial is: - to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic melanoma. - to determine the local and general safety of intramuscular electrotransferred Plasmid AMEP - to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP

Effect of chemotherapy on endothelial function in patients with testicular cancer

The aim is to study possible adverse effects of chemotherapy on endothelial function1

Resistance Exercise, Muscle Mass, Strength and Body Composition

A plethora of trials reported the positive effect of resistance exercise on functional and morphological parameters. Although a large amount of the studies used suboptimum devices and obsolete methods the results of these older studies were still considered as golden standard. The aim of the present study is thus to determine the proper effect of different resistance exercise protocols with and without adjuvant protein supplementation on functional and morphological muscle and body composition parameters in male untrained subjects 30-50 years old under special regard of modern medical imaging and segmentation technologies. Our general study hypothesis is that HIT-resistance exercise significantly impact relevant muscular parameters of the upper leg.

Evaluation of Intra-articular Injection of Autologous Protein Solution ("CertuSyn") for the Treatment of Osteoarthritis (OA)

This prospective single-center study will evaluate the safety and tolerability of a single dose of "CertuSyn" treated patients with OA of the knee who have failed conservative OA therapy. The study will also evaluate efficacy by assesing patient pain and functionality.

A prospective, single-centre, feasibility study evaluating the prevalence of diagnostic clinical imaging features of subclinical enthesitis in patients with moderate to severe plaque psoriasis and the response to skin directed treatment with Ustekinumab

Do the imaging features of subclinical enthesopathy (the earliest change seen in psoriatic arthritis), as measured by peripheral joint ultrasound (USS) and whole body MRI, in patients with moderate-to-severe psoriasis (PASI>10), change when treated for 24 weeks with ustekinumab (at standard dose) for their psoriatic skin disease?

SST0001 in Advanced Multiple Myeloma

Heparanase cleaves heparan sulfate (HS) chains, a natural substrate for heparanase, and participates in degradation and remodelling of the extra-cellular matrix (ECM) facilitating, among other activities, cell invasion associated with cancer metastasis, angiogenesis, and inflammation. The heparanase enzyme is a promising target for development of new anticancer drugs. HS and the structurally related heparin are present in most animal species. As an analogue of the natural substrate of heparanase HS, heparin is considered to be a potent inhibitor of heparanase. SST0001 is a polymer with a heparin-like structure. It is a reduced oxidized N-acetyl heparin, these modifications cause the reduction of anticoagulant activity and are strictly related to the anti-heparanase activity. In preclinical murine models SST0001 showed a significant anti myeloma effect in multiple myeloma mice xenograft models, with a significant reduction of subcutaneous growth of different multiple myeloma cell lines, when SST0001 was administered either alone or in combination with dexamethasone. The purpose of this study is to determine the safety and tolerability of escalating doses of SST0001 in the treatment of advanced refractory multiple myeloma.

A pilot, exploratory, randomized, phase 2 safety study evaluating tumor cell (plasma cell) mobilization and apheresis product contamination in plerixafor plus non-pegylated G-CSF mobilized patients and in non-pegylated G-CSF alone mobilized patients

To evaluate tumor cell mobilization (TCM) with non-pegylated G-CSF alone compared with non pegylated G-CSF plus plerixafor in patients with multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC).

Raltegravir (Isentress) Pilot Study in Relapsing Multiple Sclerosis (INSPIRE)

The purpose of this study is to determine whether raltegravir is effective in preventing progression of relapsing remitting multiple sclerosis as determined by gadolinium- enhanced MRI.

Effects of Omega-3 Fatty Acid Supplementation in Acne Patients

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.

Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet (NEUROXAPOL)

Use lay language. Oxaliplatin is a reference anticancer drug in the treatment of colorectal cancer. However, its use is hampered by a specific neurotoxicity, which is characterized by acute thermal hypersensitivity, notably to cold temperatures, and by chronic neuropathy appearing with the repetition of chemotherapy cycles. To this date there is no effective therapy able to prevent and/or to treat these adverse drug reactions. So oncologists are sometimes strained to decrease anticancer doses or to stop chemotherapy; Previously, a polyamine deficient diet has been able to prevent acute oxaliplatin-induced hypersensitivity in animals. So we hypothesizes that a specific nutritional therapy, a polyamine deprived diet, may prevent acute oxaliplatin-induced hypersensitivity in patients.

Characterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders (EnteroNeurObesity)

60 patients scheduled for bariatric surgery will be included into 3 categories (20 patients with non complicated obesity, 20 patients with metabolic syndrome and 20 patients with a type 2 diabetes or hypertension). 20 volunteers will be enrolled as normal referents. The patients and the volunteers will have a classical pre-operative check-up (fibroscopy, oesophageal pHmetry and manometry) and extra investigations as isotopic gastric empty exam, lactulose oro-caecal transit exam, intestinal permeability test calculated by lactulose-manitol ratio urinary excretion. Intestinal and colonic biopsies will be also provided for studying permeability. For only patients, samples from the gastric resection will be provided for analysing the enteric nervous system and motricity.

PRevention of Macular EDema After Cataract Surgery (PREMED)

Cystoid macular edema (CME) is a swelling of the central and most important part of the retina. It is a common cause of vision loss after cataract surgery. In the last few years, several new treatments have been tried to address the problem of CME after cataract surgery in diabetic and non-diabetic patients. However, no randomised controlled clinical trial (RCT) has compared all the currently existing preventive interventions and no study has been conducted to investigate whether combining different preventive strategies has an additional effect. Therefore, the investigators will perform a large RCT with the aim to provide more definite evidence-based recommendations for clinical guidelines to prevent the occurrence of CME after cataract surgery in patients with and without diabetes mellitus (DM). This is a non-inferiority trial and for that reason our null hypothesis states that all treatment options are equally effective. The outcomes of this RCT will be of benefit to all cataract surgeons.

Noninterventional Examination of Subcutaneous (sc) Tumor Necrosis Factor (TNF) Inhibitors (NexT)

This prospective, post marketing, observational, Noninterventional Study (NIS) is designed to compare drug persistence in patients treated with Certolizumab Pegol (CZP) and patients treated with any other subcutaneously (sc) administered Tumor Necrosis Factor (TNF) inhibitor.

Safety,PK/PD, Food Effect Study of Orally Administered HM71224 in Healthy Adult Male Volunteers

HM71224 is a potent small molecule inhibitor of Bruton's tyrosine kinase (BTK). BTK is a member of the Tec family of non-receptor protein tyrosine kinases. BTK is mostly expressed in hematopoietic cells such as B cells, mast cells and macrophages. BTK plays key roles in multiple cell signaling pathways including B-Cell Receptor (BCR) and Fc receptor (FcR) signaling cascades and is an essential mediator not only in B-cell dependent but also in myeloid cell dependent inflammatory arthritis. HM71224 has been selected as a novel therapeutic agent for the treatment of autoimmune diseases such as RA. In view of the above, further development of HM71224 for the treatment of RA is warranted. In this first-in-man (FIM) study, a single and multiple dose escalation design will be employed, in which the primary objective is to evaluate the safety and tolerability of the compound. The biomarkers included as pharmacodynamic (PD) variables are chosen as they are indicators for any effects of HM71224 on the expected mode of action (pBTK, pPLCγ, and pERK).

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

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.

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)

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

REVISE-Diabesity: Randomisation to Endoluminal intestinal liner alone Versus with Incretin analogue in SustainEd Diabesity

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?

Renal Denervation in Treatment Resistant Hypertension (ReSET-2)

The purpose of this double-blind, randomized and sham controlled study is to investigate the blood pressure lowering effect of renal denervation by catheter based ablation in the renal arteries in patients with milder forms of treatment resistant hypertension. The effect on blood pressure will be evaluated by 24-hour ambulatory blood pressure measurements at baseline and after 3 and 6 months of follow up. Secondary endpoint evaluation comprises hemodynamic assessment by applanation tonometry and the cold pressor response.

Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma

Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and prior first-line therapy (Ipilimumab-immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival

Tumor Bank for Blood Samples

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.

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

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.

Training With Whole Body Vibration Device in Patients With PAH (GALILEO-PAH)

Title of study / project: Influence of training with whole body vibration device on Quality of Life (QoL), exercise capacity, as well as on the effects of muscle power and muscle function in patients with pulmonal arterial hypertension (PAH). Background and rationale for the proposal:Capacity and the ability to exercise, in patients with PAH is limited. There is a few investigations evaluating the effects of the training with whole body vibration (wbv) in adults. It was shown that wbv-training could improve muscle power, QoL, body balance and had positive effects on the neuromuscular system. Primary scientific question addressed:Changes in muscle power, changes in 6-Minute Walk Distance (6MWD) and changes in QoL are to be evaluated.

ARTDIVA Study : First in Man Safety Evaluation of the ART18Z Bioresorbable Stent

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.

A Randomized Double Blind Placebo Controlled Parallel Group Study of the Efficacy and Safety of Pregabalin (BID) in Subjects with Post-Traumatic Peripheral Neuropathic Pain

To evaluate the efficacy of pregabalin (150-600 mg/day) compared with placebo in the treatment of chronic post-traumatic peripheral neuropatic pain

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

The objective is to assess the coagulation competence of the fluids

Endocuff Adenoma Detection Rate Pilot Study

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.

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

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.

Front-line Treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) With Dasatinib (CML1113)

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.

Assessment of Clinically Related Outcomes and Biomarker Analysis for Translational Integration in Colorectal Cancer (ACROBATICC)

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)

A Controlled Clinical Trial of Cathodal Transcranial Direct Current Stimulation in Patients With Refractory Epilepsy

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.

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

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

Efficacy Study of Neridronate to Treat Painful Osteoarthritis of the Knee With Bone Marrow Lesions.

The purpose of this study is to determine whether neridronate is effective in the treatment of pain related to bone marrow oedema in patients with osteoarthritis of the knee.

Effectiveness of Betaserc® (Betahistine Dihydrochloride) in Patients With Vestibular Vertigo in Routine Practice (VIRTUOSO)

The purposes of this international post-marketing observational program is to investigate effectiveness of betahistine dihydrochloride (Betaserc®) tablets and assess the course of vestibular vertigo after treatment discontinuation in population of Russia and Ukraine outpatients suffering from vestibular vertigo in pragmatic clinical settings. Exploratory analyses of results from both participating countries may be expected to provide insights about the subjective circumstances of vestibular vertigo patients in a wider than usual range of gender, underlying ICD-10 diagnosis, national and cultural situations.

A phase I/II study of first line Ganetespib with pemetrexed/cisplatin, in patients with malignant pleural mesothelioma

The principal research question for the phase I study is to find the maximum tolerated dose of Ganetespib, and use this information with the number of chemotherapy cycles administered to determine the most appropriate dose of Ganetespib for the phase II trial. For the phase II study, the principle research question is to determine whether adding Ganetespib to pemetrexed and cisplatin using the dose from the Phase I part of the study, versus pemetrexed and cisplatin chemotherapy improves progression free survival (first disease progression or death of any cause).

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs

Determine whether baricitinib monotherapy is noninferior to MTX monotherapy in the treatment of patients with moderate to severe active RA who have had limited or no treatment with MTX and are naive to other conventional or biologic DMARDs, as assessed by the proportion of patients achieving a 20% improvement in American College of Rheumatology criteria (ACR20) at Week 24.

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

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

Effects on Exercise Hemodynamics of Vasopressin Blockade by Conivaptan Infusion in Heart Failure

To test if infusion of the V1A/V2-receptor blocker conivaptan improves hemodynamics and physical capacity in HF patients on optimal HF medical therapy and to improve understanding of the role of vasopressin in HF.

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

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)

Spectroscopy From Duodenum

Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to adenocarcinoma patients.

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

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.

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)

The main aim of this project is to test the hypothesis that the presence or absence of specific synovial cellular and molecular signatures(B cells and B cell-associated signatures), assessed following a synovial tissue biopsy, will enrich for response / non-response to the B cell depleting anti-CD20 monoclonal antibody (mAb) Rituximab. The primary aim of this project is to show that in patients failing anti-TNF therapy, with a B cell poor synovial pathotype, Rituximab is inferior to Tocilizumab therapy.

BOTOX® for the Treatment of Urinary Incontinence due to Neurogenic Detrusor Overactivity in Patients with Multiple Sclerosis

Evaluate the safety and efficacy of 100 U BOTOX compared to placebo injected into the detrusor for the treatment of urinary incontinence due to NDO resulting from MS, in patients who are not catheterizing at baseline, and whose symptoms have not been adequately managed with an anticholinergic therapy.

An open-label, multi-arm, non-comparative safety and tolerability study of canakinumab (ACZ885) in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA)

Part I: To evaluate the long-term safety and tolerability of canakinumab and to assess the retention rate of canakinumab treated patients Part II: To assess the long-term safety and tolerability of canakinumab

Efficacy Study of Sunitinib and Everolimus (Rotational Versus Sequential Arm) in Patients With Metastatic Clear Cell Renal Cancer (SUNRISES)

The objective of this study is to assess the progression-free survival, of patients who receive rotations of sunitinib and everolimus versus patients who receive sunitinib as a first line treatment followed by everolimus when progression occurs.

A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)

To determine whether abiraterone acetate in combination with low-dose prednisone and ADT is superior to ADT alone in improving survival in subjects with mHNPC with high risk prognostic factors.

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)

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.

Multicentre, randomised, double-blind, parallel group, placebo-controlled study on the therapeutic efficacy and safety of beclomethasone dipropionate suspension for inhalation 800 micrograms twice daily vs placebo added to antibiotic therapy in patients with acute rhinosinusitis

To demonstrate that BDP suspension for inhalation twice a day for 14 days added to antibiotic therapy improves clinical success rate and accelerates recovery in patients with acute rhinosinusitis.

Rituximab in Systemic Sclerosis (RECOVER)

The purpose of this study is to determine whether rituximab is effective in the treatment of articular symptoms that occur in systemic sclerosis related polyarthritis

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

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

The Effects of Atorvastatin Treatment in COPD Patients

This study aims to determine whether statins have an anti-inflammatory effect on the lungs of patients with COPD.

Once versus twice daily mesalazine to introduce remission in pediatric ulcerative colitis: a randomized controlled trial

To compare once daily dosing to twice daily dosing

Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma (MAESTRO)

This Phase 3 trial is a randomized, double-blind, placebo-controlled trial of gemcitabine in combination with TH-302 compared to gemcitabine in combination with placebo in subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma. Randomized subjects will receive TH-302 plus gemcitabine or gemcitabine plus placebo in 4-week cycles until there is evidence of progressive disease, intolerable toxicity, or the subject discontinues from the trial for other reasons (for example, withdrawal of consent). The primary efficacy endpoint is overall survival (OS) time. The data cut-off for statistical analyses of the primary and secondary endpoints will be reached when 508 events (deaths) will be reported. No planned interim analyses will be conducted. An Independent Safety Monitoring Board (ISMB) will provide periodic evaluations of the unblinded safety data to ensure subject safety and the validity and scientific merit of the study. A total of 660 subjects will be enrolled.

A Randomized, Open-Label, Multicenter Phase II Study of Ipilimumab Retreatment versus Chemotherapy for Subjects with Advanced Melanoma who Progressed after Initially Achieving Disease Control with Ipilimumab Therapy Protocol Amendment 01- Pharmacogenetics Blood Sample Amendment, site specific (version 1.0, dated 27-Aug-2012)

The purpose of the study is to compare the 18-month overall survival rate in subjects with advanced melanoma receiving ipilimumab monotherapy (3 mg/kg) as retreatment versus chemotherapy of investigator’s choice in subjects who are randomized at the time of ipilimumab retreatment eligibility. This comparison will be done after the last randomized subject had the chance to be followed for 18 months.

A single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With BI-505, a Human Anti–Intercellular Adhesion Molecule 1 Monoclonal Antibody, In Patients With Smoldering Multiple Myeloma

To assess the tumor response rate (defined according to the IMWG uniform response criteria)

A Phase II Trial of combination treatment with Vorinostat, Bortezomib and Dexamethasone in participants with Relapsed Multiple Myeloma

To assess the overall response rate (partial response or better) of patients with relapsed multiple myeloma, after combination treatment with vorinostat, bortezomib and dexamethasone.

RETREAT(F) (REmoval of Treatment for patients in REmission in psoriatic ArThritis – Feasibility study). A randomised controlled trial to compare withdrawal of therapy versus continuing therapy in low disease states in psoriatic arthritis – feasibility study, RCT Arm

For this feasibility study we wish to know the proportion of eligible patients who are willing to undergo treatment withdrawal and the proportion remaining in minimal disease at the end of the study period. Within the three month treatment withdrawal period, a minimal disease activity (MDA) score of 5 or more (achievement of the minimal disease activity criteria) will be used to confirm continuing low disease activity. A person not achieving the MDA criteria at any of the monthly assessment time points will be deemed to be experiencing a flare of their disease. The proportion of patients who flare will also be used to inform the full study.

Laser Speckle Contrast Imaging for Cutaneous Microvascular Dysfunction Detection in Systemic Sclerosis. (SPECIES)

The aim of the study is to determine if postocclusive hyperemia of palmar and dorsal face of the hand with Laser speckle contrast imaging discriminate between patients with systemic sclerosis, subjects with primary Raynaud's phenomenon and healthy subjects.

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

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.

Dantrolene in catecholaminiergic polymorphic ventricular tachycardia

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

A phase II, single arm, open label study of treatment-free remission after achieving sustained MR4.5 on nilotinib

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.

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

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

Phase II trial of oral vinorelbine in Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) positive mutation after a failure to treatment with EGFR Tyrosine Kinase Inhibitors (TKI) in first line.

To evaluate the disease control rate (CR, PR, SD) of oral vinorelbine as a single agent in patients with lung cancer and a EGFR positive mutation, previously treated with tyrosine kinase inhibitor

Effects of Chemotherapy on Muscle Mass and Exercise Performance in Patients With Oesophageal Cancer. (Oeso-Chemo)

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.

A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.

Adoptive T cell therapy plus vaccination in metastatic melanoma patients

The primary objective of this study is to demonstrate safety of ACT plus low does IFN-alpha followed by vaccination with autologous tumor cells.

A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood

To assess the effects of rotigotine over placebo on improvement of apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic Parkinson?s disease

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment with MK-3102 in Subjects with Type 2 Diabetes Mellitus

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.

A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects with Previously Untreated Unresectable or Metastatic Melanoma Pharmacogenetics Blood Sample Amendment 01- dated 20-sep-12, version 1.0

The purpose of this study is to compare the clinical benefit, as measured by duration of overall survival, of BMS-936558 vs. Dacarbazine in subjects with previously untreated, unresectable or metastatic melanoma

EURAD-MR Classification : European Multicenter Study

An adnexal mass is the most common indication for gynaecological surgery . Pre operative characterization is crucial and a scoring system would be useful to standardize the imaging report and thus, improve patient management. Recently, our center developed the first MR scoring system named ADNEXMR SCORING system in a retrospective study which is accurate and reproducible (1). Our objectives are to perform an external prospective validation of this scoring system, to evaluate its potential impact on therapeutic strategy and to test its reproducibility. This is a prospective large multicenter study. All patients with a sonographically indeterminate adnexal mass referred for MR imaging will be consecutively included in each center. Then, patients will undergo a routine pelvic MR imaging. Prospectively, one senior and one junior radiologists independently analyze the different MR criteria to characterize adnexal masses. The MR report will be issued as standard and the patient will be managed accordingly. Then, the reader will classify the mass using ADNEXMR SCORING system. The classification will be compared to the reference standard as defined below. The reproducibility of the classification will be tested between the junior and the senior radiologist. After anonymisation, images will be analyzed by another senior radiologist of another center blinded from any clinical or ultrasonographical data and correlated with the reference standard.

Treatment of Urge Urinary Incontinence in Women After Failure of Cesa or Vasa (URGE II)

Urge urinary incontinence can be a disorder caused by destroyed pelvic structures. We repaired the uteri-sacral ligaments (USL) by cesa or vasa. The study evaluates if solifenacin can lead to continence after surgery or if also the pubo-urethral ligaments (PUL) need to be repaired.

Contribution of High Resolution EEG Functional Connectivity Measures to Presurgical Evaluation of Patients With Intractable Epilepsy (conneXion)

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.

Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women (URGE I)

The purpose of this study is to determine if pelvic surgery can improve urge urinary incontinence in women more than standard medical treatment.

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

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

Adjuvant peginterferon alfa-2b for 2 years vs Observation in patients with an ulcerated primary cutaneous melanoma with T(2-4)bN0M0: a randomized phase III trial of the EORTC Melanoma Group.

The main objective of the trial is to prospectively assess the efficacy, toxicity, quality of life with PEG IFN alfa-2b as compared to observation after adequate surgery for ulcerated primary cutaneous melanomas with T(2-4)bN0M0. The primary objective is to determine whether post-operative adjuvant therapy with PEG IFN alfa-2b improves relapse-free survival (PFS) as compared to observation.

A Phase IV Acceptability and Feasibility Trial of the Effects of Medication on Memory in Idiopathic Nondementing Parkinson’s Disease.

This is a feasibility study designed to inform the following process / primary outcomes: • to obtain estimates of memory performance which will inform a power calculation; • to explore with patient-participants and carers barriers to participation which include management of symptoms during washout period. This will be achieved formally using the end of study focus group as well as informally during mid-and end of study clinic visits with clinical members of research team, and during ON/OFF research visits with the PhD student/assessor.

Simvastatin as adjuvant therapy to correct neutrophil dysfunction in older pneumonia patients - a randomised double blind placebo controlled trial

Pneumonia (severe lung infection) is one of the commonest causes of death and the death rate has not fallen for many years. Elderly patients are at greater risk of pneumonia and its complications such as sepsis. Usually the immune system works cooperatively to clear infection and prevent organ damage. Neutrophils are cells of the immune system that are critical in clearing bacteria. These cells are the foot soldiers of the immune system and move from the blood into infected tissues/organs to locate and kill the invading bacteria using an arsenal of toxic products. Sepsis occurs when the bodies normally helpful reaction to infection becomes harmful. As part of this process, neutrophils stop working properly, they become less able to clear bacteria and release their toxic products indiscriminately, causing organ damage. Defects in the efficiency of these cells is associated with a poor outcome from pneumonia and sepsis.

A single center, randomized parallel group pilot study to investigate the mechanism of action of tapentadol PR and oxycodone CR in subjects with osteoarthritis knee pain

To assess which pain mechanisms (with specific focus on the descending inhibition) are modulated by daily administration of 2 x 100-250 mg tapentadol PR compared to 2 x 20-50 mg oxycodone CR in subjects with osteoarthritic (OA) knee pain during a treatment period of 4-weeks (preceded to a titration period of up to 15 days).

Efficacy and safety of a fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg vs betahistine dihydrochloride 16 mg in patients with vertigo of peripheral origin. A multi-centre, double-blind, randomised, active-controlled, stratified two-parallel group clinical study

The main objective is to demonstrate that the antivertiginous efficacy of the fixed combination cinnarizine/dimenhydrinate is non-inferior to betahistine dihydrochloride 16 mg in patients suffering from vertigo of peripheral origin.

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

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

A multicentre, randomised, double-blind, parallel group study on the therapeutic efficacy and safety of Febuxostat (taken once daily) and the therapeutic efficacy and safety of Allopurinol on serum urate concentration in subjects suffering from hyperuricemia and gout.

The primary study objective is to determine whether Febuxostat 80 mg, given once a day, is better than Allopurinol 300 mg/die considering the proportion of subjects, at visit 1 (week 4), whose serum urate concentrations will be below 6 mg/dL (357 µmol/L).

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis

Determine whether baricitinib 4 mg QD is superior to placebo in the treatment of patients with moderately to severely active RA who have had inadequate response to or are intolerant to at least 1 cDMARD (cDMARD-IR [inadequate response] patients) and who have not received a biologic DMARD, as assessed by the proportion of patients achieving ACR20 at Week 12.

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

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

A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma

Modified progression free survival (mPFS) per independent review facility (IRF)

A Study of Decreased Dose Frequency in Patients With Systemic Juvenile Arthritis Who Experience Laboratory Abnormalities During Treatment With RoActemra/Actemra (Tocilizumab)

This open-label Phase IV study will evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of RoActemra/Actemra (tocilizumab) in reduced dose frequency in patients with adequately controlled systemic juvenile idiopathic arthritis who have experienced a laboratory abnormality on twice weekly RoActemra/Actemra dosing. Patients will receive RoActemra/Actemra 12 mg/kg or 8 mg/kg intravenously every 3 weeks. After 4 consecutive infusions, patients who experience an event of neutropenia, thrombocytopenia or liver enzyme abnormality will move to every 4 weeks RoActemra/Actemra administration. Anticipated time on study treatment is 52 weeks.

COMBI-AD: A phase III randomized double blind study of dabrafenib (GSK2118436) in COMBInation with trametinib (GSK1120212) versus two placebos in the ADjuvant treatment of high-risk BRAF V600 mutation-positive melanoma after surgical resection.

To evaluate the efficacy of dabrafenib and trametinib combination therapy compared to two placebos with respect to relapse-free survival (RFS) in patients with completely resected, histologically confirmed, BRAF V600E/K high-risk, stage III cutaneous melanoma

A Randomized Double-blind Study to Evaluate the Safety and Efficacy of Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates

The primary objective of this study is to evaluate if the effect of administering denosumab (60 mg subcutaneously [SC] every 6 months [Q6M]) is not inferior to that of zoledronic acid (5 mg intravenously [IV] once yearly) in postmenopausal women with osteoporosis previously treated with oral bisphosphonates with respect to change in bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA) of lumbar spine at 12 months.

The Efficacy of EMDR in Patients With PTSD in Multiple Sclerosis

The primary aim is to evaluate the efficacy of the treatment with Eyes Movement Desensitization and Reprocessing(EMDR) in PTSD secondary to MS. EMDR is the elective treatment (together with Cognitive Behavioural Therapy) for PTSD according to international guidelines. The secondary aims are to evaluate the efficacy of EMDR on the PTSD-associated symptoms of anxiety and depression and Quality of Life. The study design is a randomized clinical trial.

Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis

This study will compare the effectiveness of Denosumab treatment Q6M with once yearly Zoledronic Acid treatment on Bone Mineral Density (BMD) at various skeletal sites.

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

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.

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

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.

Barrett's Intervention for Dysplasia by Endoscopy (BRIDE)

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.

A randomized, double blind, placebo-controlled, multicenter phase III study of regorafenib in patients with hepatocellular carcinoma (HCC) after sorafenib

The objective of this study is to evaluate efficacy and safety of regorafenib in patients with HCC who have progressed after sorafenib

A Phase I/IIa Sporozoite Challenge Study to Assess the Efficacy of Candidate Combination Malaria Vaccine Approaches using the ChAd63 and MVA vectors encoding the antigens ME-TRAP, CS and AMA1.

This is a clinical trial in which healthy volunteers will be administered experimental malaria vaccines. One group of volunteers will receive a vaccination composed of a mixture of the ChAd63 ME-TRAP and ChAd63 CS vaccines, followed by another vaccination 8 weeks later with a mixture of the MVA CS and MVA ME-TRAP vaccines. Another group will receive a vaccination composed of a mixture of the ChAd63 ME-TRAP, ChAd63 CS and ChAd63 AMA1 vaccines, followed by another vaccination 8 weeks later with a mixture of the MVA CS, MVA ME-TRAP and MVA AMA1 vaccines. The principal research objective is to measure how well each of these two new malaria vaccine strategies act to prevent malaria disease. This is called efficacy. We will measure it by infecting volunteers with malaria and seeing whether the vaccines change how long it takes for malaria disease to develope.

Pneumonia treated with rifampicine attenuates inflammation

To demonstrate reduced release of inflammatory components from the bacterial cell wall by adding a short course of rifampicin to standard medical treatment of community acquired pneumonia. In this way less inflammatory biomarkers will be released and less inflammation may lead to shorter duration of hospitalization en more rapid improvement of symptoms (morbidity).

Study With Trabectedin in BRCA1 and BRCA2 Mutation Carrier and BRCAness Phenotype Ovarian Cancer (MITO15)

This is a multicenter phase II study on trabectedin in advanced or recurrent ovarian cancer patients with BRCA mutation and BRCAness phenotype. The purpose of this study is to determine the feasibility in terms of objective response rate by RECIST version 1.1 (Complete and Partial Response [CR + PR]) with trabectedin in patients with BRCA1 or BRCA2 mutation carrier or BRCAness phenotype advanced ovarian cancer patients.

A 12-week, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia

To evaluate the overall efficacy of aripiprazole IM depot as acute treatment in subjects with schizophrenia.

A Dose-finding Study of a Combination of Imatinib and BYL719 in the Treatment of 3rd Line GIST Patients

The purpose of this study is to determine a maximum tolerated dose and/or recommended phase 2 dose of a combination of imatinib and BYL719 in the treatment of 3rd line GIST patients.

Fungiscope - A Global Emerging Fungal Infection Registry

The objective of this registry is to broaden the knowledge on epidemiology, diagnostic procedures and clinical course of emerging invasive fungal infections.

A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-α Antagonists

To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) is effective for: • reduction of signs and symptoms at week 24 and • improvement of physical function over 24 weeks in patients with active rheumatoid arthritis (RA) who are inadequate responders or intolerant to tumor necrosis factor alpha (TNF-α) antagonists

Bevacizumab and Trabectedin +/- Carboplatin in Advanced Ovarian Cancer

This study is aimed at assessing the efficacy and the safety of the combination of bevacizumab and trabectedin with or without carboplatin in adult women with epithelial ovarian cancer at first recurrence occurred 6-12 months after the end of the first platinum-containing regimen. According to the Bryant and Day design the primary endpoints will be the proportion of progression-free patients at 6 months for the efficacy, and the proportion of patients with severe toxicity for the safety at the same time-point.

TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors (68-DOTANOC-GEP)

Evaluation of the diagnostic performance of PET / CT with 68Ga-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors with comparison with other techniques used in routine clinical practice (octreoscan ® ; multiphase SPECT / CT, MRI or endoscopy). Therapeutic impact and safety of PET / CT with 68Ga-DOTANOC will also be assessed. Expected results are a confirmation of the superiority of 68Ga-PET DOTANOC versus scintigraphy octreoscan ®, with a potential impact on the therapeutic management of patients.

Activity and Safety Study ok BKM120 in Monotherapy in Patient With Metastatic Head and Neck Cancer Recurrent or Progressive (PIK-ORL)

The aim of this study is to determine the activity , to assess the safety and tolerance of BKM120 in adult patients with recurrent or metastatic head and neck cancer progressive under patin and cetuximab-based chemotherapy.

ImmunoTEP for Patients With Medullary Thyroid Carcinoma. (iTEP-CMT)

The aim of this study is to optimize pretargeting parameters using pharmacokinetic and imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288 peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at least one abnormal lesion

A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain

To assess the effects of Rotigotine over placebo on improvement of Parkinson’s disease associated chronic pain in subjects with advanced-stage Parkinson’s disease experiencing Parkinson’s disease associated chronic pain.

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.

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.

Double blind randomized study to assess the efficacy of BF2.649 compared to placebo in add-on to sodium oxybate in the treatment of narcoleptic patients with residual excessive daytime sleepiness (EDS) during 8 weeks.

To show relevant beneficial effect of BF2.649 on EDS compared to placebo in add on to sodium oxybate in narcoleptic patients with residual EDS. This trial will characterize the efficacy of BF2.649 compared to placebo in showing an incremental improvement to the situation achieved by the use of sodium oxybate particularly in terms of a reduction of EDS as measured by the Epworth Sleepiness scale (ESS). In addition the change in the average number of cataplexy attacks per week will be assessed.

Prevalence of Food Allergies to Proteins From Different Legumes

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.

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.

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.

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

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

Trial of 1 Cycle of Adjuvant BEP Chemotherapy in High Risk, Stage 1 Non-seminomatous Germ Cell Testis Tumours

High-risk stage 1 NSGCTTs are curable with careful surveillance followed by 3 cycles of BEP (bleomycin, etoposide, cisplatin with 500mg/m2 of etoposide per cycle) chemotherapy for the 40-50% of cases experiencing recurrence. Alternatively, adjuvant chemotherapy with 2 cycles of BEP(at a lower dose than that used for advanced disease - etoposide 360mg/m2) for these patients achieves the same outcome and avoids intensive surveillance, but delivers 33% more chemotherapy cycles on a population basis. If a single cycle of BEP at the dose used in advanced disease had a similar high rate of relapse-free survival (cure) to that seen with two lower dose cycles, this would reduce the overall burden of chemotherapy and healthcare resource usage and would be likely to lead to a change in practice globally.

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

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.

LYmphadenectomy After NeoAdjuvant Chemotherapy (LYANA)

The purpose of this study is to determine the role of lymphadenectomy in advenced ovarian cancer patients at the time of interval debulking surgery after neoadjuvant chemiotherapy. Moreover it is a prospective trial, aimed to investigate the prognostic role of sistematic lymphadenectomy in terms of percentage of micrometastases detected, morbidity (complications rate), progression free interval, overall survival, recurrence pattern.

A Study to Assess Learning Performance in Patients With Schizophrenia and Young and Elderly Healthy Volunteers

The purpose of this study is to measure and contrast implicit and explicit learning performance in patients with schizophrenia relative to young and elderly healthy volunteers.

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

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

Ascending Multiple-Doses of AMG 334 in Healthy Subjects and in Migraine Patients

The primary purpose of this study is to determine whether AMG 334 is safe and well tolerated in healthy subjects and migraine patients. As part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (PK) profile of AMG 334 after multiple SC doses in healthy subjects and migraine patients, as well as to characterize the effect of AMG 334 on the capsaicin induced increase in dermal blood flow after multiple SC doses in healthy subjects and migraine patients.

A multi-centre, randomised, double-blind, placebo-controlled, dose ranging study to evaluate the safety and efficacy of GSK2586184 in patients with chronic plaque psoriasis

To estimate the relationship between dose of GSK2586184 and clinical response as assessed by PASI score after 12 weeks of treatment in patients with moderate to severe plaque-type psoriasis.

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co administered with Ribavirin (RBV) in Treatment-Experienced Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)

The primary objectives of this study are to assess the efficacy (the percentage of subjects achieving SVR12, HCV RNA < lower limit of quantification [LLOQ] 12 weeks following treatment) and safety of ABT-450/r/ABT-267, and ABT-333 co-administered with RBV for 12 weeks in pegIFN/RBV treatment-experienced HCV genotype 1-infected adults.

A Phase I-II Study of PAXG in Stage III-IV Pancreatic Adenocarcinoma (PACT-19)

The aim of this trial is to determine the recommended dose of nab-paclitaxel in combination with cisplatin, capecitabine, and gemcitabine, PAXG regimen (Phase I), and to evaluate the feasibility and the activity of the PAXG regimen in patients with stage III and IV pancreatic cancer.

Randomized phase II trial with irinotecan as monotherapy compared to irinotecan and bevacizumab (BevIri) for patietns with platinum resistant non-resectable esophagus-, cardia or gastric cancer

To evaluate the efficacy of bevacizumab and irinotecan in combination compared to irinotecan alone in patients with esophagus, cardia or gastric cancer.

Improving Work Outcome for People With Severe Mental Illness

The purpose of this study is to investigate the efficacy of IPS in Denmark and compare effects of 1. Individual Placement and Support (IPS) vs. 2. IPS + cognitive remediation and work-related social skills training vs. 3. standard intervention, among individuals with severe mental illness.

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

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

Ambulatory Oxygen Effects on Muscles in COPD (OM-COPD)

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.

Sentinel Node in Ovarian Cancer (SONAR)

As most cancers, ovarian cancer also spreads to regional lymph nodes. The concept of sentinel lymph node surgery is to see whether the cancer has spread to the very first lymph node or sentinel node. If the sentinel node does not contain cancer, there is a high likelihood that the cancer has not spread to other lymph nodes. This means that, at least theoretically, a radical lymphadenectomy could be omitted and thus the associated morbidity. The sentinel node technique has been proven to be effective in different cancers such as breast cancer and malignant melanoma. In gynaecological tumors it has been shown to be effective in vulvar cancer. Currently sentinel node studies are done for cervix and uterine cancer. The present study determines whether or not a sentinel node procedure in patients with ovarian cancer is feasible when the tracers are injected in the ovarian ligaments.

Obstructive Sleep Apnea Syndrome (OSA) and Getemed (GETEMED)

It is often clinically impossible to differentiate children with an isolated snoring from those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based polysomnography. This expensive examination is poorly accessible due to appointments delays at hospital. Our study is designed to compare the characteristics of a home polysomnography versus standard polysomnography for the diagnosis of pediatric OSA.

A pilot study of Concerta XL in adult offenders with ADHD

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.

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

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).

A randomized, double-blind, parallel group, placebo controlled Phase II study to evaluate the safety and efficacy of two inhaled LASAG regimens and Placebo, applied three times daily in adult hospitalized patients with acute serious influenza

The primary objective of this study is to evaluate the clinical efficacy of two different doses of inhaled LASAG plus standard of care compared to placebo plus standard of care in patients hospitalized due to acute serious influenza OR an influenza caused worsening of a primary medical condition measured by time to alleviation of influenza symptoms.

A phase II, multicenter, single-arm study of oral LDK378 in crizotinib naïve adult patients with ALK-activated non-small cell lung cancer

To demonstrate the antitumor activity of LDK378, as measured by overall response rate (ORR) to LDK378 by investigator assessment

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

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

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

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

Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy

The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin

Variations in plasma concentration in patients with non-small cell lung cancer on fixed-dose erlotinib

The hypothesis of the project is that erlotinib given as at a fixed dose of 150mg to all patients’ results in a variable plasma concentration of the drug. This would in turn lead to a variation in anticancer effect and toxicity. The project will determine the size of this person-person variability. Should a sizeable difference be found, it would indicate the need for further studies of potential differences in anticancer activity and toxicity and a re-assessment of drug dosage.Erlotinib hydrochloride is the active substance of Tarceva, which is used to treat advanced stage non small cell lung cancer and pancreatic cancer. This project deals with non small cell lung cancer (NSCLC) patients only. Erlotinib is a reversible tyrosine kinase inhibitor (TKI), that specifically targets the epidermal growth factor receptor (EGFR), which is sometimes highly expressed and occasionally mutated in various forms of cancer.

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

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.

Funen's strategy in the prevention of Blood clots in critically ill patients with acute kidney Injury

To reduce the incidence of venous thromboembolism(VTE) among patients on continuous renal replacement therapy (CRRT) by using 1 mg/kg enoxaparin, versus the standard dose of 40 mg enoxaparin.

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

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

A Phase II/III, Multi-center, Randomized, Controlled Study to Compare the Efficacy and Safety of Gemcitabine Alone vs. ON 01910.Na Combined with Gemcitabine in Patients with Previously Untreated Metastatic Pancreatic Cancer

The primary objective of the study is to compare overall survival in chemotherapy-naive patients with metastatic pancreatic cancer receiving gemcitabine 1000 mg/m2 weekly combined with ON 01910.Na at 1800 mg/m2 via 2-hour continuous intravenous infusions administered twice weekly for 3 weeks of a 4-week cycle vs. gemcitabine alone at 1000 mg/m2 weekly for 3 weeks of a 4-week cycle.

What is the clinical and cost effectiveness of oral steroids in the treatment of acute lower respiratory tract infection (LRTI)? A placebo controlled randomised trial

Does the use of oral prednisolone reduce the duration of moderately bad or worse cough and / or the severity of all its associated symptoms on days 2 to 4 by at least 20% when compared to no steroid treatment in adults ≥18 years presenting to primary care with acute LRTI?

Randomized, placebo-controlled and double blind clinical trial to assess the efficacy of ubidecarenone in patients diagnosed with fibromyalgia

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)

Alemtuzumab and rheumatoid arthritis - an immunisation study

To compare the ability to mount immune responses (to measure the function of the immune system) in patients who received alemtuzumab for rheumatoid arthritis between 1991 and 1994 and a matched control group with long-standing rheumatoid arthritis. The control group will be matched for disease duration (within 5 years of matched case), age (within 10 years of matched case) and gender.

A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579 AM3)

The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and tolerability of oral posaconazole in immunocompromised children with neutropenia or expected neutropenia.

Efficacy and Safety Study of Sorafenib to Treat Advanced Medullary Thyroid Carcinoma (SUMMIT)

The purpose of his study is to evaluate the efficacy and safety of Sorafenib versus placebo in subjects with locally advanced medullary thyroid cancer (MTC). The primary study objective is to compare the Progression-free Survival (PFS) of the Sorafenib treatment group with the placebo treatment group in patients with advanced MTC.

Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma (STRATUS)

The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.

A Dose-escalation Study to Investigate Safety and Toleration of OZ439

A randomised, placebo-controlled, dose-escalation study to investigate safety and toleration of OZ439 OD for 3 days to healthy male and female volunteers. The study aims: To determine the safety and tolerability of ascending doses of OZ439 OD for three days. To assess pharmacokinetic parameters of ascending doses of OZ439 given OD. To identify the maximum tolerated dose of OZ439 administered.

Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma. (1716-12)

This study seeks to evaluate the safety and biological effects of single and multiple administrations of HSV1716 in the treatment of malignant pleural mesothelioma.

Multimodal Imaging in Pre-surgical Evaluation of Epilepsy (EPIMAGE)

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.

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

After 54 weeks, to assess the A1C-lowering efficacy of MK-3102 compared to glimepiride. To assess the safety and tolerability of MK-3102.

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

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

Pharmacokinetics of Levosimendan in children with acute heart failure

To describe the pharmacokinetic profile of levosimendan in children

A phase III, double-blind, placebo-controlled study of vemurafenib versus vemurafenib plus GDC-0973 in previously untreated BRAFV600-mutation positive patients with unresectable locally advanced or metastatic melanoma

To evaluate the efficacy of vemurafenib in combination with GDC-0973, compared with vemurafenib and placebo, in previously untreated BRAFV600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by prolongation of progression-free survival (PFS), as assessed by the study site investigator.

An Open-label, Randomized, Active Comparator-Controlled, Adaptive Parallel-group Phase 2 Study to Assess the Safety and Efficacy of Multiple Doses of ISIS 416858 Administered Subcutaneously to Patients Undergoing Total Knee Arthroplasty

• To assess the safety and efficacy profile of ISIS 416858, including incidence of bleeding and VTE, in patients undergoing total knee arthroplasty • To assess a potential dose-response relationship of ISIS 416858 with respect to the reduction of VTE incidence in patients undergoing total knee arthroplasty

Localized High-Risk Soft Tissue Sarcomas Of The Extremities And Trunk Wall In Adults: An Integrating Approach Comprising Standard Vs Histotype-Tailored Neoadjuvant Chemotherapy

This is a randomized Phase III clinical trial in the setting of localized high-risk soft tissue sarcomas (STS). This study will compare a standard neoadjuvant chemotherapy with epirubicin plus ifosfamide versus a histology-driven chemotherapy, i.e. a chemotherapy tailored to the specific histology within the family of adult STS. Chemotherapy will be administered for 3 cycles. There will be five histological groups (representing 80% of STS), as follows: leiomyosarcoma, myxoid liposarcoma with hypercellularity (round cell MLPS), synovial sarcoma, malignant peripheral nerve sheath tumor (MPNST) and undifferentiated pleomorphic sarcoma. The histology-driven chemotherapy for these groups will be, respectively, gemcitabine plus dacarbazine, trabectedin, high-dose ifosfamide, ifosfamide plus etoposide, gemcitabine plus docetaxel. Other histological groups will also be included and registered, but treated only by standard chemotherapy. Patients who have already undergone definitive surgery will receive treatment post-operatively and patients needing a re-excision after inadequate surgery will be treated as patients in the two groups, but of course will not be evaluable for response. A centralized pathological review will be performed. Radiological response will be evaluated according to RECIST and to Choi criteria. Pathological response will also be recorded.

ITT-PMS Extension An extension study of intrathecal therapy with monoclonal antibodies in progressive multiple sclerosis

To assess long-term stabilising effects of on neurological symptoms by regular IT administered monoclonal antibodies in MS.

VERtebral Fracture Treatment Comparisons in Osteoporotic Women (VERO)

The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy.

Nonivamide/Nicoboxil Ointment in Acute Low Back Pain

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.

A Randomized Multicenter Study Comparing Pixantrone + Rituximab with Gemcitabine + Rituximab in Patients with Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed after Therapy with CHOP-R or an Equivalent Regimen and are Ineligible for Stem Cell Transplant

To evaluate the efficacy (as measured by overall survival) of pixantrone plus rituximab compared to gemcitabine plus rituximab in patients with a diagnosis of de novo DLBCL, DLBCL transformed from indolent lymphoma, or follicular grade 3 lymphoma who have relapsed after at least 1 prior chemotherapy regimen and who are not currently eligible for high-dose (myeloablative) chemotherapy and stem cell transplant.

Re-irradiation of High Grade Gliomas: a Quality of Life Study

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.

Nitrate, Chronic Obstructive Pulmonary Disease (COPD) and Exercise

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.

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)

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.

Study of Clinical and Biological Prognostic Factors in Patients With Ovarian Cancer Receiving Carboplatin +Paclitaxel With Bevacizumab (MITO16/MANGO-2)

The addition of bevacizumab to first-line chemotherapy has been shown to improve progression free survival for patients with ovarian cancer. The purpose of this study is to explore the potential role of clinical and biologic factors in identifying those patients who benefit most from this combined therapy in terms of progression free and overall survival.

A multicenter, single-arm, open-label study with pomalidomide in combination with low dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma

Evaluate the safety of the combination of pomalidomide (POM) and low dose dexamethasone(LD-DEX) in a large cohort of subjects with refractory MM or relapsed and refractory MM.

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

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.

A Study of the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease

A random controlled study to investigate the effect of a new drug, ONO-8539, on oesophageal pain hypersensitivity in patients with gastric reflux disease

A 6 months, randomized, multicenter, parallel-group, open-label study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosis

To evaluate the effect of an individualized patient support program vs. a standard patient support program on treatment satisfaction, measured by a treatment satisfaction questionnaire (TSQM-9) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.

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

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

A phase III single arm study to evaluate the efficacy, safety and local tolerability of a subcutaneous 3‑month formulation of triptorelin pamoate (11.25 mg) in patients with locally advanced or metastatic prostate cancer.

To confirm the efficacy of triptorelin pamoate (11.25 mg)prolonged release (PR) formulation by inducing castration (defined as serum testosterone level of <50 ng/dL or <1.735 nmol/L) at Day 29 and maintaining castration at Day 183 (after receiving two subcutaneous (s.c.) administrations of triptorelin pamoate, 3 months apart).

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

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.

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)

To demonstrate that the efficacy of E5501 (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic thrombocytopenic purpura) (ITP) as measured by durable platelet response

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

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.

A Phase II, single-arm clinical trial of administration of cisplatin and 5-fluorouracil with afatinib as first-line therapy in patients with inoperable gastric or gastroesophageal junction cancer

The primary objective of this study is to evaluate the activity of the combination mCisFU-A (modified cisplatin, 5FU, afatinib) in patients with inoperable, locally advanced or metastatic gastric or gastroesophageal adenocarcinoma in terms of objective response, in accordance with RECIST 1.1.

A Randomized, Double-blind, Comparative Study of ZYTIGA (Abiraterone Acetate) Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)

To determine whether ZYTIGA in combination with low-dose prednisone and ADT is superior to ADT alone in improving survival in subjects with mHNPC with high risk prognostic factors.

A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis

To explore the efficacy of mavrilimumab compared to an anti-TNF antibody in adult subjects with moderate-to-severe active RA who have had an inadequate response to one or two other anti-TNF agents.

I-124 PET/CT Based Remnant Radioiodine Ablation Decision Concept in Differentiated Thyroid Cancer (CLERAD-PROBE)

This study is designed to compare effectiveness of treatments following and evaluating guideline recommendations in two assignment arms.

Efficacy and safety of fixed-dose combination Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg versus Perindopril 5 mg / Indapamide 1.25 mg single pill in patients with uncontrolled essential hypertension after 1 month of treatment by Perindopril 5 mg / Indapamide 1.25 mg single pill with conditional titration based on blood pressure control up to Perindopril 10 mg/ Indapamide 2.5 mg / Amlodipine 10 mg. An international, multicentre, randomised, double blind, 12-weeks superiority study.

To demonstrate the superiority effect of fixed-dose combination Perindopril / Indapamide / Amlodipine in single-pill versus bi-therapy in single pill in lowering office systolic blood pressure at the end of one month of treatment.

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

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.

An international collaborative study to discontinue Imatinib/Glivec® in pediatric CML patients with sustained complete molecular response (STOPIMAPED)

To estimate the percentage of quantitative RT-PCR negative pediatric CML patients in which Imatinib discontinuation result in sustained complete molecular remission

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

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.

Clinica trial PHASE I-II of LEDC (Liposomal Encapsulated Doxorubicin Cytrate, Myocet®) + CARBOPLATIN IN EPITHELIAL ginecological CANCER

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.

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.

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

A Phase 2b, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects with Heart Failure

Determine the efficacy of a single intracoronary infusion of 1 x 10e13 DRP MYDICAR® added to an optimal HF regimen in patients with ischemic or dilated cardiomyopathy and NYHA class III/IV symptoms of heart failure (HF) by reducing the frequency and/or delaying HF-related hospitalizations compared to placebo-treated patients

Randomised double-blind, placebo-controlled, cross-over study comparing the effects of single dose and repeated dosing treatment for 14 days of vestipitant / paroxetine combination in an enriched population of subjects with tinnitus and hearing loss

To measure the change in tinnitus loudness (VAS) after single (Day 1) and repeated (Day 14) administration of either vestipitant-paroxetine combination, or vestipitant alone vs. placebo.

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)

• 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

A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis

Safety Objective: • To examine the safety and tolerability of up to 24 weeks’ treatment with VB-201 or placebo in subjects with UC Efficacy Objective: • Base Phase: To examine the effect of treatment with VB-201 80 mg BID compared to placebo (initial 12 weeks) on measures of disease activity in subjects with UC. • Extension Phase: To examine the effect of longer-term treatment with VB-201 (24 weeks) on measures of disease activity in subjects with UC.

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety and Efficacy of a Single Treatment of AGN-214868 in Patients With Postherpetic Neuralgia

To evaluate the safety, tolerability, and efficacy of AGN-214868 compared with placebo in the treatment of postherpetic neuralgia (PHN).

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)

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)

Hyperthermic intra-peritoneal chemotherapy (HIPEC) in Ovarian cancer recurrence: Randomized trial on Survival Evaluation.

To assess disease progression-free interval after surgery combined with intraperitoneal chemo-hyperthermia with respect to the exclusive secondary cytoreduction.

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)

• 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

A Pharmacokinetic Analysis of Posaconazole in the Plasma and Alveolar Compartment of Lung Transplant Recipients

a) To estimate the time taken to achieve a steady level (steady state) of posaconazole in the blood in cystic fibrosis (CF) and non-CF transplant recipients. b) To examine the relationship between blood posaconazole levels and posaconazole levels in the lungs in cystic fibrosis (CF) and non-CF transplant recipients.

Prognosis and Treatment of COPD in Primary Care-use of Biomarkers (PROTECCT-M)

This is an observational study in primary care aiming to validate biomarkers for chronic obstructive pulmonary disease (COPD).

Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Northern Hemisphere Season 2012/2013. An Open-Label, Baseline-Controlled Study in Two Age Groups: Adult Subjects ≥ 18 and ≤ 60 Years and Elderly Subjects ≥ 61 Years of Age.

The primary objective of this study is to determine the immunogenicity of the trivalent influenza subunit vaccine Influvac® for the northern hemisphere season 2012/2013, three weeks after vaccination according to the CHMP Note for Guidance on Harmonization of Requirements for Influenza Vaccines (CPMP/BWP/214/96) in two age groups: - Adult subjects aged ≥18 and ≤ 60 years. - Elderly subjects ≥ 61 years of age. Safety Objective: To collect evidence on the safety (unsolicited adverse events) and tolerability (reactogenicity and overall inconvenience) of Influvac®.

An Open-Label Study of the Effect of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus

The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with HCV on a telaprevir-based regimen in Part A and with dose adjustments if needed before Part B.

Randomized, double-blind, placebo-controlled trial to compare the effect, three months of follow-on pulse pressure and vascular function of isosorbide mononitrate extended release, associated with antihypertensive treatment in patients over 65 years refractory isolated systolic hypertension

To compare the effect on clinic pulse pressure of extended release isosorbide mononitrate vs placebo, added to the usual treatment of patients over 65 with refractory ISH, after 3 months of treatment.

A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients with Active Psoriatic Arthritis

Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on ACR20 at 24 Weeks

A prospective phase II study to assess immunophenotypic remission after three-drug in-duction followed by randomized stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance in patients with newly diagnosed multiple myeloma

The objectives of this study is to determinate the rate of immunophenotypic remission after induction treatment with Revlimid Velcade Dexamethasone (RVD) prior to high-dose melphalan and autologous stem cell transplantation (HDT-ASCT), after HDT-ASCT, and during lenalidomide maintenance in patients with multiple myeloma.

Phase shift in adult ADHD of sleep and apetite.

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

A Study of Ixekizumab in Participants With Active Psoriatic Arthritis (SPIRIT-P1)

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.

Intervention Trial in Early Age-related Macular Degeneration (I-TEAM)

The purpose of the I-TEAM project is to assess whether there is a change in visual function and status of the retina after a year of intervention in subjects with early signs of Age-related Macular Degeneration.

An exploratory study evaluating the efficacy of cromoglicate cream compared to cream vehicle in the treatment of itch in psoriasis

To investigate the clinical efficacy on itch of treatment with cromoglicate cream in subjects with itchy psoriasis

A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis

To evaluate the long-term efficacy of secukinumab with respect to ACR20, ACR50 and ACR70 response over time up to Month 60 in patients who completed the phase III study CAIN457F2309

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

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

Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.

The objective of this study is to establish if the effectiveness of the SIMS Ajust® is non-inferior to that of a standard TOT, as well as to compare the comorbidity of both procedures. Owing to the new appearance and fast evolution of these procedures, randomized comparative studies with SIMS are required in order to determine its place in the treatment of SUI.

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

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.

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

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

Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ularitide (Urodilatin) Intravenous Infusion in Patients Suffering from Acute Decompensated Heart Failure [TRUE-AHF]

To evaluate the effect of a continuous intravenous (IV) ularitide infusion on the clinical status of patients with ADHF.

MicroBubble detection and Ultrasound guided Biopsy of axillary Lymph nodes in patients with Early breast cancer.

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.

Significance of COX-2 inhibition in first line treatment of extensive disease small-cell lung cancer (ED-SCLC)

Investigate the efficacy of combination of celecoxib and standard chemotherapy as first line treatment for ED-SCLC

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

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

Sumatriptan non-responders: evaluation of a possible biomarker

Investigate the effect of sumatriptan and placebo on the rise of dermal blood flow caused by capsaicin application and iontophoresis of normal saline.

Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging (TeDi-C2)

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.

Biomarkers Before and After Nephrectomy of Locally Advanced or Metastatic Renal Cell Carcinoma Treated With Everolimus (NEORAD)

A Comparison of Blood and Tissue Biomarkers Before and After Nephrectomy in the First-line Setting With Everolimus in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma

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

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.

A randomized phase II trial comparing bevacizumab monotherapy with dacarbazine (DTIC) in treatment of malignant melanoma, focusing on angiogenic markers and prevention of hypertension.

The primary objective of this trial is to compare efficacy of bevacizumab monotherapy with standard chemotherapy (DTIC) in patients with metastatic or unresectable malignant melanoma.

Phase-1 Study of Folinic Acid to Modulate MGMT Gene in Glioblastoma (FOLAGLI)

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.

An Extension Study to Evaluate Six Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003

• Provide additional information on safety in study subjects receiving six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo. • Provide information on the vertebral fracture rate in subjects receiving six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo. • Provide additional information on non-vertebral fractures and BMD change associated with six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo.

A 6 Week, Randomized, Multicenter, Double-blind, Double-dummy Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 1-5 Years Old With Hypertension, With or Without Chronic Kidney Disease, Followed by a 20 Week Openlabel Titration Phase

To evaluate if a dose dependent reduction in MSBP exists when comparing two doses of valsartan solution over a 6wk period in children 1-5 years old with hypertension with or without CKD.

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

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)

30 day, open-label, active-controlled, randomized study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in children with various manifestations of venous thrombosis

The primary objective is to assess the incidence of major bleeding and clinically relevant non-major bleeding

Apathy in Schizophrenia

Apathy, defined as a quantitative reduction of voluntary, goal-directed behaviours (GDB), is a core component of negative symptoms. It has been suggested that the physiopathology of apathy is not a single entity but may be multiple, depending on which specific process or macrofunction is disrupted during completion of GDB. In line with this notion, Levy and Dubois proposed dividing apathic syndromes into three subtypes of disrupted processing: 'a-motivation', 'cognitive inertia', and 'uncoupling'. In schizophrenia, apathy has been associated with executive dysfunction, functional impairment and poor outcome. However, the neurobiological underpinnings of apathy in schizophrenia are poorly understood. Primary objective: confirm that chronic schizophrenic patients are apathic compared to healthy volunteers

The Most Effective Treatment Strategy for Diabetic Macular Edema.

To evaluate whether laser photocoagulation prolongs treatment effect of anti-VEGF for DME.

Sparing of Organs at Risk in High Dose Rate Brachytherapy

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.

Stretta In Reflux Uncontrolled by IPP (SIRUP)

The aim of the study is to compare the Stretta procedure and the Sham procedure efficiency 6months post-procedure in reflux uncontrolled by intake of Inhibitors of Protons Pump (IPP) patients.

Mesacol: The effect of mesalazine on molecular pathways of cell adhesion in ulcerative colitis

To evaluate the changes in molecular pathways of cell adhesion (cellular localization of E-cadherin and ß-catenin) in ulcerative colitis prior to and after treatment with mesalazine (5-ASA)

Stem Cells Treatment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)

Evaluate the feasability and security of the autologous ASC for the femenine stress urinary incontinence

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

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

A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy

The primary objective is to assess the efficacy (as measured by the reduction of the signs and symptoms of RA) of JNJ-38518168-ZBQ at doses of 3, 10, and 30 mg/d compared with placebo in subjects with active RA despite concomitant MTX therapy.

Potentiating clinical and immunological effects of chemotherapy by neutralizing acidic pH at tumor site: a phase II randomized study in melanoma patients

1. Significant increase in the systemic anti-tumor immune response (evaluated as IFN gamma Elispost in response to autologous melanoma cells or HLA-compatible antigenic peptides and phenotypic profile leukocyte, including of immunosoppressorie subpopulations immunosoppressorie as Treg and MDSC) in the arms of combination ECT IL2 and ECT LANS, compared to ECT as a single treatment; 2. Increase of pathological tumor response and of the anti-tumor immune infiltrate T, possibly associated with a decrease of negative regulatory cells (Treg and MDSC) in ECT treated lesions, in the arms of combination ECT IL2 and ECT LANS, compared to ECT as a single treatment

A multicenter, randomized, doubleblinded, parallel-group, placebocontrolled study to assess the efficacy and safety of skeletal muscle-derived cell implantation in female patients with stress urinary incontinence

The aim of this clinical study is to show clinical efficacy and safety of SMDCs in patients suffering from SUI and to show superiority of SMDCs in female patients with moderately severe SUI over placebo.

A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis

To evaluate the safety, tolerability and effects of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI parameters.

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

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.

A Randomised, Phase II Study Evaluating MK-1775 in Combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin Alone in Adult Patients with Platinum Sensitive p53 Mutant Ovarian Cancer

(1) To evaluate the effect of MK-1775 in combination with paclitaxel + carboplatin compared with placebo in combination with paclitaxel + carboplatin on progression free survival (PFS) per enhanced Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 in patients with platinum sensitive p53 mutant ovarian cancer. (2) To determine the safety and tolerability of MK-1775 in combination with paclitaxel + carboplatin in patients with platinum sensitive p53 mutant ovarian cancer.

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

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.

An open label study with objective sleepregistration on the effects of Doxazosin as treatment for PTSD, especially for sleep disturbance

The purpose of this study is to evaluate the effect on sleep and ptsd of the drug doxazosin in patients with PTSD who also have sleep problems.

A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, with and without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination with Ribavirin, in the Treatment of Naìve Genotype 2 and 3 Chronic Hepatitis C Subjects

The primary objective is to evaluate, in treatment-naive subjects with chronic HCV GT-2 or -3 infection: • SVR12 following 24 weeks of treatment with Lambda/RBV and the SVR12 following 24 weeks of treatment with alfa-2a/RBV • SVR12 following 12 weeks of treatment with Lambda/RBV/DCV and the SVR12 following 24 weeks of treatment with alfa-2a/RBV

A Phase I/II Trial of TG01 and Gemcitabine as Adjuvant Therapy for Treating Patients with Resected Adenocarcinoma of the Pancreas

To assess the potential for interference of Gemcitabine on immune response to TG01 as determined by TG01 specific DTH skin test reaction and T-cell function in peripheral blood in patients receiving TG01 and GM-CSF after primary resection of pancreatic adenocarcinoma

Randomized, Double-Blind, Placebo-Controlled Trial of Ferric Carboxymaltose Versus Placebo in Patients with Congestive Heart Failure

The hypothesis to be tested is whether treatment with intravenous iron (ferric carboxymaltose) will improve LV-EF in patients with CHF and iron deficiency as determined by cardiac MRI.

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

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

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)

An extension open-label safety study of a 24-month 20mg dose regimen of tasimelteon for the treatment of non-24-hour sleep-wake disorder (n24hswd) in blind individuals with no light perception who have enrolled in other tasimelteon clinical trials

The primary objective of this study is to characterize the effect of tasimelteon, 20 mg/night for 24 months, on standard measures of subject safety.

A multi-center, randomized, double-blind, three-arm, 16 week, adaptive phase III clinical study to investigate the efficacy and safety of LAS41008 vs LASW1835 and vs Placebo in patients with moderate to severe plaque psoriasis

The primary objectives of the study are: - Superiority of LAS41008 versus placebo based on the proportion of subjects achieving PASI 75 at week 16 (a 75% reduction in the Psoriasis Area and Severity Index, PASI, compared to baseline. - Superiority of LAS41008 versus placebo based on the proportion of subjects achieving a score of “clear” or ”almost clear” in the Physician’s Global Assessment (PGA) after 16 weeks of treatment. - Non-inferiority of LAS41008 compared to LASW1835 (internal code for Fumaderm®) regarding PASI 75 after 16 weeks of treatment.

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

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.

Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices (CAPTURE)

To monitor post-market performance through evaluation of short and long-term performance via: Efficacy / Safety / Patient reported outcomes

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

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

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

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.

A phase 2 multi-center, randomized, double-masked, placebo controlled, multi-dose study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of RN6G (PF 04382923) in subjects with geographic atrophy secondary to age-related macular degeneration

To determine the efficacy of RN6G in subjects with geographic atrophy in the study eye.

A Three-part Study of Eltrombopag in Thrombocytopenic Subjects with Myelodysplastic Syndromes or Acute Myeloid Leukemia (Part 1: open-label, Part 2: randomized, double-blind, Part 3: extension). ASPIRE: A Study of EltromboPag In Myelodysplastic SyndRomes and AcutE Myeloid Leukemia

Part 1 open-label, 8 week first part of the study are: • To evaluate the safety and tolerability of eltrombopag. • To determine optimal dose escalation scheme for use in Part 2 of the study by assessing the dose of eltrombopag required to achieve platelet count response. • To characterize plasma eltrombopag pharmacokinetics (steady-state plasma eltrombopag Cmax, tmax, AUC(0-τ), CL/F, and half-life). Part 2: • The primary objective of this study is to determine reduction in the number of clinically relevant thrombocytopenic events (CRTE) in subjects with MDS or AML who have Grade 4 thrombocytopenia (<25 Gi/L) and are treated with eltrombopag compared to those treated with placebo. Part 3: The objectives of Part 3 of the study are to evaluate the long-term durability of clinical benefit as well as overall survival, the long-term safety and tolerability of eltrombopag in subjects with MDS and AML.”

A Phase III placebo-controlled, double-blind, randomized trial to evaluate the efficacy and safety of TMC207 in subjects with sputum smear-positive pulmonary infection with multi-drug resistant Mycobacterium tuberculosis (MDR-TB)

The primary objective is to demonstrate that TMC207 added to a BR is superior to this BR plus placebo in regard to the proportion of subjects with favourable treatment outcome 60 weeks after randomization (i.e., 36 weeks of treatment and 24 weeks of treatment-free follow-up). A favourable treatment outcome requires confirmed culture conversion at Week 60.

A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Sunitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day

A phase IV study to evaluate decreased dose frequency in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA) who experience laboratory abnormalities during treatment with tocilizumab

Efficacy: • To explore the efficacy of TCZ in reduced dosing frequency regimens (Q3W and Q4W, as appropriate) using Juvenile Arthritis Disease Activity Score (JADAS)-71, JIA flare, and fever Pharmacodynamic: • To describe the pharmacodynamics, using sIL-6R and C-reactive protein (CRP), and immunogenicity of TCZ in reduced dosing frequency regimens.

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

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.

The Efficacy of Continuous Intra-articular Infusion of Local Anaesthetic Agent following Elective Primary Hip Arthroplasty

To determine whether the use of a continuous intra-articular infusion of local anaesthetic might reduce the need for post-operative opiate use in patients undergoing hip replacement.

Pain management in osteoarthritis using the centrally acting analgesics duloxetine and pregabalin

The proposed study is based on the hypothesis that pain in hand osteoarthritis is due to local changes in the joint and the switching on of pain pathways in the brain that mediate chronic pain. The overall aim of this study is to determine whether drugs which influence central brain pain processing pathways can improve pain management in hand osteoarthritis. The primary objective of this study is to determine the effects of centrally acting drugs duloxetine and pregabalin versus placebo on pain perception in hand osteoarthritis using clinical pain scores.

A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs. Prednisone in Metastatic Castration-resistant Prostate Cancer Patients who have Received Prior Docetaxel and Prior Abiraterone or MDV3100

The objective of this study is to evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-α Therapy

To determine the effects of MK-8457 100 mg BID compared to placebo over 12 weeks of treatment as measured by ACR20 response. To determine the safety and tolerability of MK-8457 100 mg BID compared to placebo over 12 weeks of treatment.

Safety, Tolerability and Effectiveness of Glocophage®SR in patients with type-2 Diabetes and Chronic Kidney Disease (eGFR 30 to 45mL/minute/1.73m2)

1% Change in HbA1c at the end of study from baseline in the Glucophage® SR group of the study, compared to placebo.

A phase III, open-label, multicentre study to evaluate the immunogenicity, safety and reactogenicity of a revaccination dose of the GlaxoSmithKline Biologicals' quadrivalent seasonal influenza candidate vaccine GSK2321138A, administered to children who previously participated in study 115345 (FLU D-QIV-004 PRI).

To assess the immune response in terms of Haemagglutination Inhibition (HI) antibody titre at Day 7 after one dose of FLU D-QIV vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all strains included in the vaccine.

A phase II observer blind, randomised, controlled study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ candidate tuberculosis vaccine GSK 692342 when administered to adults aged 18 to 59 years with TB disease

To assess the safety and reactogenicity of GSK Biologicals’ candidate TB vaccine M72/AS01E in the study population.

Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis

The main objective of the trial is to proof the non-inferiority of an 8-week treatment with three times daily 1000mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis

Observational Study of Prolia® in Postmenopausal Women With Osteoporosis

The study is being performed to describe Prolia® patients' medication-taking behavior in a non-interventional routine clinical care setting

A Long-Term Open-Label Extension Study for Subjects Completing a Phase 3 Efficacy and Safety Study of Lesinurad Monotherapy in Subjects with Gout

To determine the long-term efficacy and safety of lesinurad monotherapy.

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

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

Adjuvanting Viral Vectored Malaria Vaccines With Matrix M

ChAd63 METRAP and MVA METRAP are investigational vaccines for malaria which have been studied in clinical trials for 4 years, and 10 years, respectively. These vaccines are inactivated viruses which have been modified so that they cannot reproduce in humans. Genetic information has been added to make them express proteins of the malaria parasite so that they stimulate an immune response against malaria. This trial examines whether a compound called Matrix M™ can be used in efforts to improve on how well the vaccines work at preventing malaria. Matrix M™ is a vaccine adjuvant, a compound used to improve the immune responses to vaccines. In this trial, Matrix M™ will be combined with each of the vaccines. The objectives are to assess the safety of the vaccines when combined with Matrix M™, and to determine what effect Matrix M™ has on the immune responses to the vaccines.

Safety of oral chronic administration of ivabradine modified release formulation compared to ivabradine immediate release formulation in patients with chronic heart failure and left ventricular systolic dysfunction. A 6 to 12-month randomised double blind parallel groups multicentre study.

To compare the safety profiles of the ivabradine modified release (MR) formulation and ivabradine immediate release (IR) formulation over a 6-month period

Doppler quantitative evaluation and follow-up over 12 months in RA patients with moderate and high disease activity who are candidates for biologic add-on therapy with Adalimumab

To study the relationship between RA disease activity based on Doppler quantification and the subsequent clinical response (EULAR response) to treatment with Adalimumab during 12 months.

A Phase 3 Study to Assess the Efficacy and Safety of Boceprevir in Combination with Peginterferon alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1

• To assess the efficacy of boceprevir used in combination with peginterferon alfa-2b (PEG2b) plus ribavirin (RBV) in non-cirrhotic, treatment naïve pediatric subjects with chronic hepatitis C (CHC) genotype 1. • To evaluate the safety and tolerability of BOC/PR in pediatric subjects. • To assess in pediatric subjects who are non-cirrhotic, treatment failures or who are cirrhotics the proportion of subjects who achieve SVR when they are retreated with BOC/PR. • To evaluate the safety and tolerability of BOC/PR in pediatric subjects who are non-cirrhotic, treatment failures or who are cirrhotics. • To confirm the durability of the virologic response in the subjects who were sustained responders at 24 weeks posttreatment in Part A or Part B. • To characterize the long-term safety of boceprevir, including growth assessment and sexual maturation, in subjects who received treatment in Part A or Part B.

A Phase II, Open-Label, Multicentre, Extension Safety and Tolerability Study for Transfusionally Iron Overloaded Children, Adolescents and Adults using FBS0701 (SSP-004184 ).

Measure the extent and durability of FBS0701 treatment effects; continue to assess the safety, tolerability and efficacy of FBS0701 (SSP-004184) in subjects who received FBS0701(SSP-004184) in prior Ferrokin sponsored study; allow access and assess response to FBS0701 (SSP-004184) in subjects randomised to another chelating therapy in a prior FerroKin-sponsored FBS0701(SSP-004184) study.

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

To compare the safety profiles of the ivabradine modified release (MR) formulation and ivabradine immediate release (IR) formulation over a 6-month period

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

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.

A randomized, double blind study comparing BF2.649 (Pitolisant) to placebo in two parallel groups on the weekly frequency of cataplexy attacks and Excessive Daytime Sleepiness in narcoleptic patients with cataplexy

The main objective is the measure of the anticataplectic efficacy of BF2.649 compared to placebo, assessed by the change in the average number of cataplexy attacks per week between the 2 weeks of baseline and the 4 weeks of stable treatment period.

A multicenter, two stage, phase II study, evaluating the efficacy of oral BEZ235 plus best supportive care (BSC) versus placebo plus BSC in the treatment of patients with advanced pancreatic neuroendocrine tumors (pNET) after failure of mTOR inhibitor therapy

To estimate the efficacy of BEZ235 in adult patients with advanced (unresectable or metastatic) pNET (PFS)

A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Ceftaroline fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects with Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus aureus

• Evaluate the efficacy of ceftaroline and azithromycin versus ceftriaxone and azithromycin plus vancomycin in adult subjects with community-acquired bacterial pneumonia (CABP) at risk for infection due to methicillin-resistant taphylococcus aureus (MRSA) • Evaluate the safety of ceftaroline and azithromycin versus ceftriaxone and azithromycin plus vancomycin in adult subjects with CABP at risk for infection due to MRSA • Evaluate the pharmacokinetics of ceftaroline in adult subjects with CABP at risk for infection due to MRSA

Effects of Sulfur Thermal Water Inhalation on Airway Oxidative Stress in COPD Patients

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.

A randomized phase II study to explore the efficacy and feasibility of upfront rotations between sunitinib and everolimus versus sequential treatment of first line sunitinib and second line everolimus until progression in patients with metastatic clear cell renal cancer.

Progression-free survival (PFS)

Multicenter, randomized, double-blind clinical trial to compare the clinical and radiological efficacy of 625 mg vs 1250 mg of oral methylprednisolone in patients with multiple sclerosis in relapse.

To assess the non-inferiority of clinical and radiological efficacy of the treatment with lower-high dose of oMP (625mg/day for 3 days) vs high dose of oMP (1250mg/day for 3 days) in patients in relapse of MS, 28 days after the treatment.

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)

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.

A randomized phase III trial of erlotinib versus docetaxel in patients with advanced squamous cell non-small cell lung cancer who failed first line platinum based doublet chemotherapy stratified by VeriStrat Good vs VeriStrat Poor

Explore the predictive ability of VeriStrat signature, by testing for interaction between treatment arms (Arm A: erlotinib vs Arm B: docetaxel) and VeriStrat status (Good vs Poor) using progression free survival as outcome.

Randomized phase II study of BEZ235 or everolimus in advanced pancreatic neuroendocrine tumors

To assess the treatment effect of BEZ235 relative to everolimus on progression free survival in patients with advanced pancreatic neuroendocrine tumors who have not been previously treated with an mTOR inhibitor.

FDDNP-PET for in vivo diagnosis of Tauopathy in unclassifiable parkinsonism

To assess the ability to detect in vivo underlying tau pathology in unclassifiable parkinsonism by means of [18F]-FDDNP

A randomised, multi-centre, parallel group, double-blind, placebo- and active-controlled clinical study to assess the efficacy and safety of Octenidine lozenges in the treatment of acute sore throat.

The primary objectives are to demonstrate superiority of Octenidine lozenges compared with placebo in terms of rate of responders, and to demonstrate non-inferiority of Octenidine lozenges compared with active comparator (neo angin®) in terms of the rate of responders.

A Multicenter, Phase II, Single-Arm Clinical Trial of nab-Paclitaxel as salvage treatment for patients with Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal junction

To evaluate the objective response (CR and PR) rates of nab-Paclitaxel as salvage treatment in patients with metastatic/locally advanced gastric or GEJ cancer previously treated with DCF.

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MT-1303 in Subjects With Inflammatory Bowel Disease

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral dose of MT-1303 in subjects with inflammatory bowel disease.

Phase II study of cabazitaxel as 2nd-line treatment in patients with HER-2 negative metastatic breast cancer previously treated with taxanes

The primary objective is to assess the clinical activity of cabazitaxel regarding the objective response rate (ORR).

A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-3

Primary Placebo-family Objectives Compared with placebo: • To evaluate the efficacy of brodalumab (210 mg every 2 weeks [Q2W]; and 140 mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index (PASI; PASI 75) at week 12 • To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving success (clear [0] or almost clear [1]) on the static physician’s global assessment (sPGA) at week 12

Open-label, uncontrolled Phase II trial of intravenous PI3K inhibitor BAY 80-6946 in patients with relapsed, indolent or aggressive Non-Hodgkin’s lymphomas

The objective of this study is to evaluate the efficacy and safety of BAY 80 6946 in patients with indolent or aggressive Non-Hodgkin’s Lymphoma (NHL) who have progressed after standard therapy.

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

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.

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

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.

Combined intra articular corticosteroid and exercise in patients with osteoarthritis of the knee: a randomised trial

To investigate the effect of phsyiotherapeutic exercise in combination with pharmacological antiinflammatory treatment on patient reported pain in patients with knee osteoarthritis.

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

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

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

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

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

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.

Urethral Length Measurement in Women Undergoing Suburethral Sling Operative Procedure

This is a prospective, non-randomized, observational, multicenter study in which urethral length is measured in women with surgically-correctable stress urinary incontinence who undergo a suburethral sling operative procedure.

Efficacy and feasibility of first-line treatment with risk-adapted dose-adjusted EPOCH-R (DA-EPOCH-R) in patients with Burkitt lymphoma. A phase II clinical trial.

• Determine efficacy, defined as PFS and OS at 2 years of risk-adaptive DA-EPOCH-R in newly diagnosed Burkitt lymphoma patients 18-75 years. • Determine feasibility, defined as > 60% of cycles of the DA-EPOCH-R scheme on an outpatient-clinic basis

A second-line, single arm, phase II clinical study with tremelimumab, a fully humanized anti-CTLA-4 monoclonal antibody, as monotherapy in patients with unresectable malignant mesothelioma

To assess the rate of objective clinical complete response (CR) or partial response (PR)

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

The primary objective of the study is to determine the objective response rate (ORR: CR+PR+SD)

A Phase III, International, Multi-Center, Randomised, Double-Blind, Placebo-Controlled, Event Driven Study to compare the Time to First Clinical Worsening in Subjects with Pulmonary Arterial Hypertension receiving UT-15C in Combination with a PDE5-I or ERA compared with a PDE5-I or ERA Alone

To assess the effect of oral UT-15C with ERA or PDE5-I therapy compared to placebo with ERA or PDE5-I therapy on time to first clinical worsening event, as defined by at least one of the events: Death (all causes),Hospitalization due to worsening PAH, Initiation of an inhaled or infused prostacyclin for the treatment of worsening PAH, Disease progression (all criteria required), Unsatisfactory long-term clinical response(all criteria required). To assess effect of UT-15C combined with oral ERA or PDE5-I therapy compared with placebo combined with oral ERA or PDE5-I therapy on the change in Baseline 6MWD measured at Week 24

A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis

To assess the effects of rFXIII on mucosal healing

A Phase 2, 24 Week, Randomized, Open Label, Multi-Center Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two FBS0701 Doses in the Treatment of Chronic Iron Overload Requiring Chelation Therapy

Evaluate, in patients with transfusion-dependent iron overload, whose primary diagnosis is hereditary or congenital anemia: - Pharmacokinetic parameters provided a constant (steady state) of two doses of FBS0701; - Changes in the concentrations of iron in the liver, after 12 and 24 weeks following administration of two doses of FBS0701; - The safety and tolerability of two doses of FBS0701, administered daily for 24 weeks.

A phase I/II trial of Cabazitaxel +/- Rhenium-188 HEDP in patients with metastatic castration resistant prostate cancer who progressed on or after a docetaxel containing treatment. The ReCab trial

To establish a safe and effective dosing schedule for repeated administration of Rhenium-188 HEDP combined with cabazitaxel in order to proceed with a Randomized Phase 2 trial designed to determine the clinical value of Rhenium-188 HEDP/cabazitaxel using overall survival as the primary endpoint. Patients included in the phase1 part with the dose schedule selected for the phase 2 part will be integrated in the final phase 2 analysis.

Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)

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.

A Phase II Multicenter, Parallel-Group, Randomized, Dose-Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following 12 Weeks of Oral Administration of GSK2336805 With Pegylated Interferon and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 or 4 Hepatitis C Infection.

The primary objectives of this study are: • To evaluate the 12-week safety and tolerability of 40 and 60 mg of GSK2336805 when given in combination with pegylated interferon alfa-2a (PEG) and ribavirin (RIBA). • To evaluate 12-week antiviral activity of 40 and 60 mg of GSK2336805 when given in combination with PEG and RIBA as measured by eRVR (defined as undetectable plasma HCV RNA at Weeks 4 and 12)

An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310

The primary objective of this study is to provide UT-15C sustained release tablets for eligible subjects who participated in TDE-PH-310 (A phase III, International multi-center, randomised, double-blind, placebo-controlled, event-driven study to compare the time to first clinical worsening in subjects with PAH receiving UT-15C in combination with a PDE5-I or ERA compared with a PDE5-I or ERA alone).

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

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

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

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

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)

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.

A Multicenter, Double-masked, Randomized Study to Compare the Safety and Efficacy of an Investigational Eye Drop Formulation with OPTIVE™ Unit-Dose for 3 Months in Subjects with Dry Eye Disease

To evaluate the safety and efficacy of Eye Drops New Platform Unit-Dose (EDNP UD) in subjects with signs and symptoms of dry eye disease

Procalcitonin-guided Detection of Streptococcal Acute Tonsillitis

The primary purpose of the present study is to investigate the usefulness of Procalcitonin as a supplement to the Streptococcal antigen test and Centor criteria in the differential diagnose making between Streptococcal and non-Streptococcal acute tonsillitis.

BMS_PD-L1_onco : Assessment of the PD-L1 Protein as a Biomarker in Oncology and Hematology

The aim of this study is to identify cells producing soluble PD-L1 in DLBCL patients at diagnosis in comparison to others tumours known to express PD-L1 (breast cancer, Hodgkin's lymphoma).

A signal seeking window trial of AZD8931 in patients with resectable non-small cell lung cancer

The primary objective of the study is to determine whether a 40mg twice daily dose of AZD8931 administered for 10-14 days (up to 18 days if surgery recheduled) results in suppression of cancer cell growth, by looking at changes in a marker called Ki67, which represents proliferation of tumour cells, before and after treatment with AZD8931.

Teriparatide and Risedronate in the Treatment of Patients with Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures

The primary objective of this study is to evaluate if teriparatide 20 μg subcutaneously once daily is superior in reducing the incidence of new vertebral fractures during 24 months of therapy, when compared with risedronate 35 mg orally once weekly, in postmenopausal women with prevalent vertebral fragility fractures.

Cabazitaxel in platinum refractory ovarian cancer. A phase II trial

To investigate the response rate of cabazitaxel in platinum refractory, ovarian cancer.

Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia (PAPALDO)

The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile neutropenia among patients with breast cancer, treated with chemotherapy and presenting with a low to moderate risk of developing febrile neutropenia.

A Phase IIa Exploratory Study of OCZ103-OS in Combination with Platinum-Gemcitabine based Doublet First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC) Patients

To obtain a preliminary evidence of the clinical efficacy of OCZ103-OS used in combination with platinum-gemcitabine based doublet first line therapy in adult NSCLC patients, by assessing primarily Overall Response Rate (ORR), as well as Duration of Response (DR), Progression Free Survival (PFS), Overall Survival (OS), Time to progression (TP) and Time to Distant Metastasis (TDM)

A Single-Arm, Open-Label Phase 2 Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus plus GM-CSF) Administered by Weekly Intravenous (IV) Infusions in Sorafenib-naïve Patients with Advanced Hepatocellular Carcinoma (HCC).

Determine radiographic response rate (based on mRECIST for HCC and mChoi criteria).

A Phase 2b Randomized Open-Label Trial of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) Plus Best Supportive Care Versus Best Supportive Care in Patients with Advanced Hepatocellular Carcinoma Who Have Failed Sorafenib Treatment.

Determine and compare overall survival for patients receiving JX-594 plus best supportive care (BSC) (Arm A) versus those receiving BSC (Arm B) in patients with advanced hepatocellular carcinoma (HCC) who have failed sorafenib treatment.

A phase II study of intratumoral application of L19IL2/L19TNF in melanoma patients in clinical stage III or stage IV M1a with presence of injectable cutaneous and/or subcutaneous lesions.

Efficacy of L19IL2/L19TNF-treated lesions measured as : Rate of patients with complete response (CR) of L19IL2/L19TNF-treated lesions at week 12 (day 85).

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

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.

Neurotoxicity characterization phase II randomized study of nab-paclitaxel versus conventional paclitaxel as first-line therapy of metastatic HER2-negative breast cancer.

To characterize neurotoxicity according to Total Neuropathy Score

Phase Ib dose finding study of abiraterone acetate plus BEZ235 or BKM120 in patients with castration-resistant prostate cancer

Dose escalation part: Define maximum tolerated dose (MTD) and /or recommended dose for expansion (RDE) of the combinations abiraterone acetate + BEZ235 and abiraterone acetate + BKM120 by assessing the incidence of dose limiting toxicities (DLTs) in cycle 1. Dose expansion part: Assess anti-tumor activity of the combinations (abiraterone acetate + BEZ235 and abiraterone acetate + BKM120) in castration-resistant prostate cancer patients with abiraterone acetate failure as on treatment Prostate specific antigen (PSA) progression according to prostate cancer working group 2 criteria (PCWG2) by assessing PSA decline ? 30% at Week 12 or later.

A 12-Week Multicenter, Randomized, Double-Blind, Placebo Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients with Moderate to Severe Plaque Psoriasis with a Long-Term Extension Period

Efficacy of ixekizumab vs. etanercept and placebo in subjects with moderate to severe chronic plaque psoriasis based on sPGA and PASI at week 12

Effect of Brivaracetam (BRV) on Nonpsychotic Behavioral Side Effects in Subjects Treated Previously With Levetiracetam (LEV)

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.

Alcohol and Tobacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support

This is a multicenter, interventional, randomized study for preventive and therapeutic strategies for patients with head and neck or Lung cancer; contribution of an addiction support

A Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Antiviral Activity of the Combination of ABT-450 with Ritonavir (ABT-450/r), ABT-267, and ABT-333 With and Without Ribavirin in Treatment-Experienced Subjects with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (PEARL-II)

The primary objectives of this study are to evaluate the safety of both arms and to compare the efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12, {HCV RNA < LLOQ 12 weeks following therapy}) with 3 DAAs with and without RBV.

Efficacy and Safety Study of Homeopathic Oral Antibodies to Treat Viral Upper Respiratory Tract Infections (ESTUAR)

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

Proof of Biological Activity of SAR100842 in Systemic Sclerosis

The primary objective is to evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse, cutaneous systemic sclerosis.

A Randomized, Open-Label, Phase 3 Study of BMS-936558 vs. Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy Pharmacogenetics Blood Sample Amendment 01- dated 18-jun-12, version 1.0

The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of BMS-936558 vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy.

An Open-Label Randomized Phase III Trial of BMS-936558 versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) Pharmacogenetics Blood Sample Protocol Amendment 01 version 1.0 dated 12-Jun-12

The purpose of the study is to compare the change in tumor size, and overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy

A Phase 2 Open-Label, Multicenter, 4-Week Study to Assess the safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Relief of Heartburn, in Adolescent subjects Aged 12 to 17 Years With Symptomatic Non-Erosive Gastroesophageal Reflux Disease

To assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules (30 mg) in adolescent subjects aged 12 to 17 years, with symptomatic non-erosive GERD.

A Randomized Phase III Study Of Low-Docetaxel Oxaliplatin, Capecitabine (Low-Tox) Vs Epirubicin, Oxaliplatin And Capecitabine (Eox) In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer

To compare the therapeutic efficacy of Docetaxel, Oxaliplatin and Capecitabine (low-TOX) vs. Epirubicin, Oxaliplatin and Capecitabine (EOX) as measured by the duration of overall survival (OS) in patient with locally advanced/metastatic gastric cancer.

Radiotherapy as an immunological booster in patients with metastatic melanoma or renal cell carcinoma treated with High-dose Interleukin-2: evaluation of biomarkers of immunologic and therapeutic response

To determine the tumor antigen-specific immune response induced by the treatment and to prospectively determine the predictive/prognostic value of pretreatment biological features in identifying patients who will benefit from HDIL-2-based therapy

Repetitive Transcranial Magnetic Stimulation With Double Cone Coil in Chronic Tinnitus (Ti-CDC)

Transcranial Magnetic Stimulation is used to modulate both the auditory neural pathways contributing to the perception of phantom sounds, and the regulatory neural network responsible for the generation of the individual amount of suffering caused by chronic tinnitus.

Radiotherapy as an immunological booster in patients with metastatic melanoma or renal cell carcinoma treated with High-dose Interleukin-2: evaluation of biomarkers of immunologic and therapeutic response

To determine the tumor antigen-specific immune response induced by the treatment 2. to prospectively determine the predictive/prognostic value of pretreatment biological features in identifying patients who will benefit from HDIL-2-based therapy

A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

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)

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)

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.

efficacy of rotigotine on gait performance of parkinsonian patients

Patients suffering for Idiopathic Parkinson’s Disease. H&Y stage > or = 2 with un-satisfactory control by on-going pharmacological therapy (Levodopa, COMT & MAO-inhibitors), characterised by an incomplete control of motor signs, in particular presence of early morning akinesia, as well as gait deficits in the morning.

A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis

Measure the proportion of subjects achieving an ASAS 20 (Assessment of SpondyloArthritis International Society criteria) response at week 16 in subgroup of patients who are TNFα inhibitor naïve compared to placebo

Comparison of the Efficacy of Diclofenac Sodium Topical Gel, 1% (Mylan) to Voltaren® Gel, 1% (Novartis US) and Placebo in Adult Subjects with Knee Osteoarthritis

The objective of this study is to investigate the clinical endpoint bioequivalence of Mylan's Diclofenac Sodium Topical Gel, 1% compared to Novartis US’ Voltaren® Gel, 1% and placebo (vehicle, Mylan) following multiple topical applications of 4 g to a single osteoarthritic knee (4 g four times daily for 4 weeks).

Radiotherapy in Association With Cetuximab in Patients Treated for an Epidermoid Cancer

This study evaluates the skin toxicities in patients with epidermoid cancer, treated by Radiotherapy in association with Cetuximab.

A double-blind, placebo controlled, parallel-group, randomised study of safety, tolerability and efficacy of AMAP102 in patients with osteoarthritis.

To assess the efficacy of AMAP102 in patients with pain secondary to osteoarthritis (OA) over 28 days of dosing

A prospective randomized phase II trial of FOLFIRINOX, and radiation therapy versus FOLFIRINOX alone in patients with locally advanced pancreatic cancer that cannot be removed by surgery

R0 resection rate

A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2

Primary Placebo-family Objectives Compared with placebo: • To evaluate the efficacy of brodalumab (210 mg every 2 weeks [Q2W]; and 140 mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index (PASI; PASI 75) at week 12 • To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving success (clear [0] or almost clear [1]) on the static physician’s global assessment (sPGA) at week 12

The Head and Neck TUMOR Biobank

The purpose of the biobank is to enable future genomic based research on this Head and Neck Cancer patient population. The investigators will try to identify tumor factors that will predict cancer-related outcome in order to improve the outcome prediction after treatment in a patient-individualized manner.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2B Trial to Evaluate the Safety and Efficacy of BMS-823778 in Overweight and Obese Subjects with Inadequately Controlled Hypertension + Pharmacogenetics Blood Sample Protocol Amendment 01- version 2.0, dated 05-Apr-2012

The purpose of this study is to determine whether BMS-823778 is safe and effective in the treatment of hypertension in overweight and obese patients.

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.

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

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

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.

Oxytocin in PTSD: effectiveness as addition to Narrative Exposure Therapy

The primary objective is to assess the effectiveness of the administration of intranasal oxytocin in addition to Narrative Exposure therapy (NET) in reducing PTSD and co-morbid depressive symptoms in patients with chronic PTSD, compared to administration of placebo. We hypothesize that both groups will show a reduction in PTSD and depressive symptoms over the course of the treatment, but that the reduction in symptoms will be faster and larger in the oxytocin group.

Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With COPD

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).

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

To evaluate the effect of AMG 181 on induction of remission in subjects with moderate to severe UC at week 8 as assessed by a total Mayo Score ≤ 2 points, with no individual subscore > 1 point

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

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

A randomized, phase III, multicenter, double-blind, placebo-controlled study evaluating the efficacy and safety of onartuzumab (metmab) in combination with 5-fluorouracil, folinic acid, and oxaliplatin (MFOLFOX6) in patients with metastatic HER2-negative, MET-positive gastroesophageal cancer

• To evaluate the efficacy of onartuzumab + mFOLFOX6 compared with placebo + mFOLFOX6 as measured by overall survival (OS) in patients with previously untreated HER2–negative metastatic gastroesophageal cancer (GEC) classified as Met IHC 2+ or 3+ (Met 2+/3+ subgroup) • To evaluate the efficacy of onartuzumab + mFOLFOX6 compared with placebo + mFOLFOX6 as measured by OS in patients with previously untreated HER2 negative metastatic GEC classified as Met-IHC 1+, 2+, or 3+ (intent-to-treat [ITT] population)

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

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.

An open-label phase II trial of erlotinib and bevacizumab in patients with advanced non-small cell lung cancer and activating EGFR mutations

To determine progression free survival (PFS) of patients with advanced non-squamous NSCLC harbouring at diagnosis EGFR mutations with and without T790M mutation, treated with the combination of erlotinib and bevacizumab. Hypotheses of interest: When treated with bevacizumab and erlotinib a. Median PFS increases to 18 months for patients with EGFR T790M mutation b. Median PFS is approximately 18 months or more in patients without EGFR T790M mutation.

Infliximab Top-down Study in Kids with Crohn’s disease

The primary objective of our study is to determine the efficacy and safety of top-down IFX treatment in moderate-to-severe pediatric CD.

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

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.

NOA-12: BIBF1120 and R-RT in Glioblastoma

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.

An Open-Label Phase I/II Study of GSK2110183 in Combination with Carboplatin and Paclitaxel in Subjects with Platinum-Resistant Ovarian Cancer

Primary Phase I To determine the safety and tolerability of GSK2110183 administered in combination with carboplatin and paclitaxel in subjects with ovarian cancer--which will be used to identify the dosing regimen to be evaluated in Phase II. Primary Phase II To evaluate the clinical efficacy (as measured by overall response rate) of GSK2110183 administered in combination with carboplatin and paclitaxel in subjects with recurrent platinum-resistant ovarian cancer.

An open label, three-period, single sequence study to evaluate the pharmacokinetic drug-drug interaction between LCZ696 and sildenafil in subjects with mild to moderate hypertension

To investigate the effect of LCZ696 on single dose pharmacokinetics of sildenafil in subjects with mild To moderate hypertension. To investigate the effect of sildenafil on the steady-state pharmacokinetics of the LCZ696 analytes in subjects with mild To moderate Hypertension

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects with Multiple Sclerosis (MOBILE)

The objectives of this study in MS subjects treated with prolonged-release fampridine 10 mg twice daily compared with subjects treated with placebo are: To assess the effect of prolonged-release fampridine over 24 weeks on the following parameters to explore endpoints for the Phase 3 study: self-assessed walking disability, dynamic and static balance, subjective impression of well-being, subjects’ global impression of change in walking To evaluate the safety and tolerability of prolonged-release fampridine.

A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies

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

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)

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

A single arm Pharmacokinetic/Pharmacodynamic Study of Sunitinib in Patients with Metastasized Renal Cell Carcinoma

Develop PK/PD models for sunitinib including biomarker response (blood pressure, sVEGFR-2, sVEGFR-3) as PD marker

A Phase III clinical trial evaluating DCVax®-L, autologous dendritic cells (DC) pulsed with tumor lysate antigen for the treatment of glioblastoma multiforme (GBM)

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

A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel-group Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS)

Evaluate the efficacy and safety of ABT-126 in the treatment of cognitive deficits in schizophrenia (CDS).

A two-part, randomized Phase II, double-blind, multicenter trial assessing the efficacy and safety of pertuzumab in combination with standard chemotherapy vs. placebo plus standard chemotherapy in women with recurrent platinum resistant epithelial ovarian cancer and low HER3 mRNA expression

Part 1: Safety Run-in Phase The primary objective for Part 1 of this study is as follows: -To determine the safety and tolerability of pertuzumab in combination with either topotecan or paclitaxel. Part 2: The primary objective for Part 2 of this study is as follows: -To determine if pertuzumab plus chemotherapy is superior to placebo plus chemotherapy as measured by progression-free survival (PFS).

Study of a Predictor for Cervix Cancer (ANOXICOL)

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

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

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).

Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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

Efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain

The primary objective is to assess the superiority of the analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic post-operative neuropathic pain (PoNP).

The effect of insulin degludec in combination with liraglutide and metformin in subjects with type 2 diabetes qualifying for treatment intensification

To confirm the efficacy of IDeg compared to placebo, both in combination with liraglutide and metformin, in controlling glycaemia

Open-label, Phase 4 Study, investigating the Incidence of Extra-Articular Manifestations in Subjects with Ankylosing Spondylitis treated with Golimumab

Determine the difference in the incidence rate of uveitis in subjects with Ankylosing Spondylitis (AS), before and after treatment with golimumab

An Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia

This multicenter, prospective, non-interventional study will evaluate the prevalence and characteristics of patients with persistent symptoms of schizophrenia and the course of their illness over 24 months.

Cupping in Fibromyalgia (CuFib)

The purpose of this randomized controlled study is to determine the effectiveness of cupping in patients with fibromyalgia compared to sham cupping.

A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate

To investigate the clinical efficacy of NNC0109-0012 compared to placebo when administered as weekly repeat s.c. injections in patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate (MTX) while on a stable background of MTX therapy.

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

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).

Treatment with Liraglutide in type 1 diabetic patients. Effects on glycemic control and counterregulation and cognitive performance during hypoglycaemia.

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.

Treatment of Diabetic Macular Edema With 0.5mg Intraocular Ranibizumab (Lucentis)

In this prospective, open-label clinical study is to investigate the behavior of the retinal functions during development of diabetic macular disease (DME) under the influence of Lucentis. Measurements with the multifocal electroretinogram (ERG) and microperimetry is used here as an objective criteria to information about the retinal function obtain.

Evaluation of the effects of the addition of atropine during propofol/remifentanil induction of anesthesia on hemodynamics, microvascular blood flow and tissue oxygenenation in patients undergoing ophthalmic surgery

Evaluation of the effects of the addition of atropine during propofol/remifentanil induction of anesthesia on hemodynamics, microvascular blood flow and tissue oxygenenation in patients undergoing ophthalmic surgery

The influence of liraglutide on hypoglycaemia counterregulation and pulsatile insulin secretion in type 2 diabetics

To establish, whether liraglutide improves the glucagon concentration under hypoglycaemic conditions in patients with type 2 diabetes

Dabigatran and rivaroxaban: prediction of anticoagulant effect

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.

Treatment of Cancer in the head and Neck: The Role of Hyperbaric Oxygen in Reducing Swallowing Problems

Potential benefit of prophylactic HBOT in terms of reducing / limiting the amount of dysphagia and / or xerostomia for tumors in the head and neck

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

The primary objective is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of RA in subjects with active RA who are refractory to an anti-TNF alpha agent.

A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects

The objective of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe Rheumatoid Arthritis (RA) subjects.

Estimation of the VQ11 Auto-questionnaire, to Follow Patients With Chronic Obstructive Pulmonary Disease (EPIC)

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.

Phase II Trial of CAP7.1 in adult patients with refractory malignancies Small cell lung carcinoma, Non-small cell lung carcinoma Biliary carcinoma

To assess the antitumor activity of CAP7.1 based on the observed objective rersponse rate and rate of disease stabilization using Recist.

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

Response rate according to RECIST 1.1

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

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

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

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.

Propofol vs. Ketamin

Better therapeutic effect of ketamin in the treatment of ECT

Prospective, open-label, non-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of octagam 10% in primary immune thrombocytopenia

To assess the efficacy of Octagam 10% in correcting the platelet count (PC).

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

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

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)

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

A Phase 2, Open-Label Study of Daclatasvir (BMS-790052) and TMC435 in Combination With or Without Ribavirin (RBV) For Treatment-Naive Subjects or Null Responders to Prior Peginterferon Alfa (PegIFN)/RBV Therapy with Genotype 1 Chronic Hepatitis C +Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, dated 14-May-12)

To assess efficacy of daclatasvir and TMC435 with and without ribavirin, as determined by the proportion of subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12.

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

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.

A Phase 2, 4 Week Randomized, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients with Painful Diabetic Peripheral Neuropathy

To assess the efficacy of GRC 17536 in the treatment of pain associated with diabetic peripheral neuropathy (DPN).

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

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.

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

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

Efficacy Study of Relaxation to 12 Weeks Against Placebo in the Overall Care Chronic Pain in Patients With Fibromyalgia (Sophrodol-1)

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

Immunomodulating and neuroprotective properties of autologous multipotent mesenchymal stem cells in patients with multiple sclerosis - A randomised placebo-controlled double-blinded phase II study

To assess the effect of intra-venously applied autologous MSCs on cerebral inflammation in multiple sclerosis patients

Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

Occult lymph node metastasis is common in micro papillary thyroid cancer. However, the role of lymph node dissection in the treatment of microPTC remains controversial. The investigators want to investigate the usefulness routine central dissection and sentinel lymph node biopsy in prognosis of micro PTC. This is a prospective randomized control study.

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

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.

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)

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

A phase II randomised trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) vs cyclophosphamide, velcade and dexamethasone (CVD) for first relapse or primary refractory multiple myeloma.

To compare the activity of carfilzomib in combination with cyclophosphamide and low dose dexamethasone (CCD) to that of the control treatment of bortezomib, cyclophosphamide and dexamethasone (CVD) in patients with multiple myeloma at first relapse. Specifically the study will assess whether CVD provides non-inferior activity with regard to the short-term outcome measure of ≥Very Good Partial Response rates at 24 weeks, and superior activity in terms of the longer-term outcome measure of progression-free survival.

Validation Study for an Unobtrusive Online Sleep Measurement System

The purpose of the study is to determine the precision of an unobtrusive sleep measurement system. The system measures a force sensor signal under the mattress and analyzes sleep quality. The system measures: time in bed, sleep stages, sleep fragmentation, heart rate, respiration rate, sleep related breathing disorders, and limb movements.

A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFα biologics

To investigate the clinical efficacy of NNC0109-0012 compared to placebo when administered as weekly repeat s.c. injections in patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFα biologics and are on a stable background of methotrexate (MTX) therapy.

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome

To evaluate the clinical response of patients with IBS-d to JNJ-27018966 relative to placebo. To evaluate the overall safety and tolerability of JNJ-27018966 in the treatment of IBS-d.

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

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.

Controlled Human Malarial Infection by Intravenous Injection of Plasmodium Falciparum Sporozoites in Non-Immune Adults

The study is designed to establish the best dose to safely infect healthy individuals with Plasmodium falciparum sporozoites (PfSPZ) via intravenous (IV) injection.

Veliparib (ABT888) and Topotecan (Hycamtin®) for Patients with Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer with Negative or Unknown BRCA Status

Phase I: To determine: Maximum-tolerated dose (MTD) Dose-limiting toxicities (DLT) Recommended phase II dose Phase II: To investigate response rates (based on either CA125 GCIG or RECIST criteria) of combination topotecan and veliparib (ABT888) in relapsed ovarian cancer with negative or unknown BRCA status.

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

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.

To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer

The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients.

The use of Tachosil as sealant in the prevention of lymphorrea after groin lymphadenectomy for vulvar cancer: a clinical controlled prospective trial

Reduction of grade 2 and grade 3 lymphedema incidence 3 months after the surgery in patients treated with TachoSil after groin Lymphadenectomy for vulvar cancer

Double-blind, randomized, 8-week placebo-controlled and 16-week open label extension study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis

To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse, cutaneous systemic sclerosis.

Double-blind, randomized, placebo-controlled, 8-week study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis

To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse, cutaneous systemic sclerosis.

Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis.

To compare the new adalimumab formulation to the currently approved (current) adalimumab formulation in a dosing regimen of 40 mg eow for 24 weeks

Effects of Linagliptin on Renal Endothelium Function in Patients with Type 2 Diabetes.

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.

An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects with Seizure Clusters

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.

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

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.

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

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).

Cisplatin and 5-FU +/- Panitumumab for Patients With Nonresectable,Advanced or Metastatic Esophageal Squamous Cell Cancer (POWER)

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.

A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men with High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology

. Assess the ability of 99mTc-MIP-1404 to detect prostate cancer within the prostate gland . Assess the clinical safety of 99mTc-MIP-1404

Study to Observe Safety and Efficacy of Nexavar in Treatment of Kidney Cancer

The objective of this Non-Interventional study is to evaluate the effectiveness & safety of Nexavar in advanced Renal Cell Carcinoma (RCC) patients under daily-life treatment conditions based on age of the patient (older (age >70 years) and younger patients (age <70 years). Specifically investigated are the tumor status, duration of Nexavar ® treatment (number of cycles) and incidence of Hand foot Skin Reaction.

Prospective feasibility study for the evaluation of indocyanine green and near-infrared imaging in sentinel lymph node biopsy for cutaneous melanoma patients: The "RED-GREEN-BLUE" melanoma study.

The principal research question is to assess the sensitivity of indocyanine green (ICG) for Sentinel lymph node detection in cutaneous melanoma in combination with technetium radio­isotope and patent blue dye.

An evaluation of adherence to LTBI treatment with 12 doses of once weekly rifapentine and isoniazid given as self-administered versus directly-observed therapy: iAdhere

To compare the treatment completion rates between participants randomized to DOT vs SAT without reminders and DOT versus SAT with weekly SMS reminders. Treatment completion is defined as taking at least 90% of the doses (11/12 doses of each drug) within 16 weeks of treatment initiation.

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

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

MRI-perfusion and FLT- and FET-PET during bevacizumab monotherapy for patients with recurrent Glioblastoma Multiforme

Determine changes in tumor perfusion parameters defined by perfusion MRI and changes in tumor proliferation defined by FLT- and FET-PET

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.

To assess the treatment effect of BKM120 once daily plus fulvestrant versus BKM120 matching placebo once daily plus fulvestrant on progression-free survival (PFS)

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

Provide radium-223 chloride to patients diagnosed with CRPC/HRPC with bone metastasis To assess acute and long-term safety of radium-223 chloride

Study of a National Cohort of Adult Patients With Phenylketonuria (ECOPHEN)

Phenylketonuria (PKU) is a metabolic disease of genetic origin. This is a rare disease (incidence 1 / 16000 births) which is the subject of a systematic neonatal screening in France, because it is treatable by a diet low in phenylalanine. This plan is required upon confirmation of diagnosis and continued until the age of 8 years. The current trend is to continue the scheme at least until adolescence. Unlike other countries, in France there are no recommendations for a plan "for life". Knowledge about the natural history of PKU in adulthood, the effects of pediatric age, the frequency of complicated shapes, and prognostic factors are poorly documented. On the other hand, there is no consensus on the therapeutic management of this disease in adulthood and monitoring that could be directed towards the detection of neurological disorders and nutrition. Social integration and quality of life of adults PKU patients living in France have not been studied.

A multicenter, double-blind, randomized withdrawal extension study of subcutaneous secukinumab in prefilled syringes to demonstrate long-term efficacy, safety and tolerability up to 2 years in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab

To demonstrate the efficacy of secukinumab 150 mg or 300 mg in subjects with moderate to severe chronic plaque-type psoriasis, who were PASI 75 responders at Week 52 of the core study, with respect to loss of PASI 75 up to Week 68, compared to placebo.

A phase II, open-label, randomized study of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum based chemotherapy

This is a phase II, open-label, randomized study of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum-based chemotherapy. The main objective is to evaluate the efficacy of MEHD7945A (administered every 2 weeks) versus cetuximab (administered weekly) in all and in biomarker positive patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN), as measured by progression-free survival (PFS).

Sympathetic renal denervation versus increment of pharmacological treatment in resistant arterial hypertension

To determine the effect of a percutaneous catheter-based renal sympathetic denervation (RSD) procedure to disrupt renal afferent and efferent nerves using radiofrequency ablation, on 24h ambulatory systolic blood pressure (SBP), in subjects with resistant hypertension (RH), as compared to the addition of spironolactone, an aldosterone receptor blocker, to the baseline pharmacological treatment, from baseline (Visit 0) to Final Examination (Week 24).

A long-term, open-label follow-up study of CP-690,550 for treatment of juvenile idiopathic arthritis (jia)

The objective of this study is to determine the long term safety and tolerability of CP 690,550 for treatment of the signs and symptoms of JIA.

Renin-Angiotensin System Quantification in patients treated with Aliskiren or Candesartan (RASQAL)

To demonstrate the quantity of differences in the renin-angiotensin peptide profiles in patients receiving direct renin inhibition or angiotensin receptor blockade.

Oral sodium bicarbonate supplementation in patients with chronic metabolic acidosis and chronic kidney disease

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.

Renin-Angiotensin System Quantification in patients treated with Aliskiren or Candesartan (RASQAL)

To demonstrate the quantity of differences in the renin-angiotensin peptide profiles in patients receiving direct renin inhibition or angiotensin receptor blockade.

Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support

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.

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)

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.

A Single Arm, Phase 2 Study of Ganetespib in Subjects with Advanced Non- Small-Cell Lung Cancer with Anaplastic Lymphoma Kinase Gene Rearrangement (ALK-Positive NSCLC)

Determine the objective response rate (ORR) of ganetespib in subjects with advanced ALK-positive NSCLC

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

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.

Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome

The main purpose of this study is the effect of the probiotic yeast Saccharomyces cerevisiae CNCM I-3856 on abdominal pain or intestinal discomfort in patients presenting with the irritable bowel syndrome (IBS)

A randomized multicenter study of accelerated fractionated radiotherapy with or without the hypoxic radiosensitizer nimorazole in the treatment of squamous cell carcinoma of the head and neck

The aim of the study is to determine the possible therapeutic gain of using nimorazole given as a hypoxic radiosensitizer in conjunction with accelerated fractionated radiotherapy of invasive squamous cell carcinoma of the larynx, pharynx and oral cavity, and evaluate the tolerance, compliance and toxicity of using nimorazole

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

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.

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

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)

Phase I Hybrid study: combined stereotactic radiotherapy and conventional fractionation in stage II and III non small cell lung cancer with peripheral tumors smaller than 5 cm

To define the recommended phase II mean-lung dose (MLD) to treat peripheral stage II or III non small cell lung cancer (NSCLC) using stereotactic ablative radiotherapy (SABR) for the primary tumor and conventional fractionated radiotherapy (CFRT) for the mediastinal lymph nodes while given concurrent chemotherapy

A randomized phase II trial comparing pazopanib with doxorubicin as first line treatment in elderly patients with metastatic or advanced soft tissue sarcoma

To show that progression-free survival in the pazopanib group is not inferior to that in the doxorubicin group

Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma

This randomized phase II/III trial is studying the safety of trabectedin compared with doxorubicin hydrochloride and to see how well they work in treating patients with advanced or metastatic soft tissue sarcoma.

Randomized Phase II Trial of Three-weekly Cisplatinum and Pemetrexed versus Split-dose d1 and d8 Cisplatinum and Pemetrexed In Advanced and Inoperable Non-squamous Non-small-cell lung cancer (NSCLC)

To evaluate and compare objective response rates in both arms while defining toxicity profiles of both application schedules. Additionally, evaluation of biologically validated, potentially predictive biomarkers and identification of new biomarkers for therapy response, therapy resistance, and course of disease in formalin-fixed paraffin-embedded (FFPE) and fresh tumour specimens as well as circulating tumour cells (CTCs), obtained before treatment and, if applicable, during and after study treatment.

A Phase 3, Randomized, Double-Blind, Multi-Center Study to Compare the Efficacy and Safety of Micafungin Versus Amphotericin B Deoxycholate for the Treatment of Neonatal Candidiasis

To evaluate the efficacy and safety of Micafungin in comparison to amphotericin B deoxycholate (CAB) in the treatment of proven neonatal candidiasis

An international, multicenter, open-label study evaluating sustained virological response and safety with Boceprevir in triple combination therapy with Peginterferon alfa-2a (40KD) and Ribavirin in treatment-naïve patients with genotype 1 chronic hepatitis C.

To evaluate the efficacy of boceprevir in triple combination therapy with peginterferon alfa-2a and ribavirin given as response guided treatment regimen (total of 28 or 48 treatment weeks) on the clearance of HCV 12 weeks after treatment end (sustained virological response) in treatment-naïve patients with genotype 1 chronic HCV infection

Cross-tumoral Phase 2 clinical trial exploring Crizotinib (PF-02341066) in patients with advanced tumours induced by causal alterations of either ALK or MET.

The study will primarily assess the efficacy of crizotinib in a variety of tumors with alterations in ALK and/or MET pathways. The targeted patient population will include patients with tumors harboring specific alterations leading to ALK and/or MET activation, where tyrosine kinase inhibitors against these targets have not yet been adequately explored.

Chronification and reversibility of migraine

We want to study the success rate of OAHM withdrawal in patients with chronic migraine related to support by a headache nurse, and onabotulinum toxin A injections during the withdrawal period, and the influence of comorbid depression.

A randomized controlled trial investigating tailored treatment with infliximab for active luminal crohn's disease

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

OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (EVOLVE)

This is an Open-label, prospective, randomized, multi-center post-market study.

A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma.

Use of acetylsalicylic acid (ASA) for enhanced early detection of colorectal neoplasms

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

An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Direct-Acting Antiviral Agent (DAA) Treatment in Combination with Peginterferon α-2a and Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects Who Have Experienced Virologic Failure in a Previous Abbott DAA Combination Study

The primary objective of this study is to evaluate the safety and antiviral efficacy, defined as the percentage of subjects with sustained virologic response 12 weeks post-dosing (SVR12; HCV RNA < LLOQ 12 weeks after the last dose of study drug).

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

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.

Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy (XALIA)

Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute deep vein thrombosis (DVT). The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT in routine clinical practice.

A Phase I/IIa trial of VTD-panobinostat treatment and panobinostat maintenance in relapsed and relapsed/refractory multiple myeloma patients

During the dose escalation phase, the purpose of the study is to determine the maximum tolerated dose (MTD) of panobinostat, administered in combination with VTD, in subjects with relapsed and relapsed/refractory multiple myeloma. In the dose expansion phase the purpose of the study is to estimate the response rate (partial response or better) within 16 cycles of VTD-pano at the RD identified in the dose escalation phase.

Insight in Persons Presenting Schizophrenia or Related Troubles During Hospitalization in Psychiatry

Therapeutic alliance, and drug observance are major difficulties in the care of persons presenting schizophrenic symptomatology. They appear to be linked to insight, the consciousness that one has of his troubles. Nurse care in psychiatry aims at improving it, but usually without using specific evaluation tool. Insight is usually not evaluated during care, and its evolution is also not known, although it is highly probable that a positive evolution of insight for a person in hospital correlated to an adapted and optimal care by the medical and nursing teams. The investigators do not know examples of insight evaluation during a sequence of hospital care, or any evidence of insight variation in relation to evolution abilities of some schizophrenic patients cared in hospital. The investigators propose here to evaluate insight in people presenting schizophrenia or related troubles, at the beginning of hospitalization (I1) and 1 month later (I2), to better characterize insight variations, and identify the sociodemographic, clinical and therapeutic variables linked to it.

An exploratory, randomized, double blind, placebo controlled, parallel groups Phase II clinical trial to evaluate the efficacy and safety of E-52862 (400 mg) by oral route, in patients with postherpetic neuralgia (PHN).

The primary objective of this study is to assess the analgesic efficacy of E-52862 in subjects with moderate to severe postherpetic neuralgia

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.

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.

A Prospective, Randomized, Doubled-masked, Single Center, Clinical Comparison of Autologous Serum, Heterologous Serum and Umbilical Cord Serum Eye Drops in the Management of Dry Eye Syndrome

To valuate tear film and ocular surface changes after autologous serum therapy, heterologous serum therapy and umbilical cord therapy in patients with severe dry eye syndrome. To accomplish clinical comparison of the effects between the three therapies.

Adjuvant PEG Intron in Ulcerated Melanoma

The purpose of this study is to evaluate the effectiveness and safety when treated with PEG IFN alfa-2b for 2 years as compared to observation (no treatment), administered after adequate surgery has been performed for ulcerated primary cutaneous melanomas.

Observation Versus Post-surgery Radiotherapy After Complete Exeresis in Soft Tissues Members Sarcoma

The main objective is to achieve a low recurrence rate while maintaining the function. The question remains the possibility of an absence of irradiation in selected cases in a de-escalation therapy order.

Randomized Study of Cisplatin-Etoposide Versus an Etoposide Regimen Without Cisplatin in Extensive Small-Cell Lung Cancer

The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival in comparison to a regimen containing etoposide and without platinum derivative.

Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors

This is a prospective multicenter phase II trial of gemcitabine, cisplatin, and ifosfamide (GIP) in patients with relapsed non-seminomatous germ-cell tumors (NSGCT) and a predicted favorable prognosis.

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

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.

Predictive Value of Whole Blood Coagulation Parameters for Post-discharge Venous Thromboembolism After Cancer Resection

This study plans to learn more about the role of 2 blood tests in predicting who might develop a blood clot in their arm or leg after major surgery. The investigators know that patients who have cancer and major surgery have a higher than normal risk of getting blood clots in the veins of their arms or legs. This can be very dangerous because the clot can move into your lungs.

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

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

A Randomized, Open-Label Phase 2 Study of EC145 Single-agent and the Combination of EC145 plus Docetaxel Versus Docetaxel Alone in Participants with Folate-Receptor Positive [FR(++)] Second Line NSCLC

This study tests the activity of single-agent EC145 and the combination of EC145 plus docetaxel against the current standard docetaxel in second line NSCLC in participants with all target lesions expressing the folate receptor [FR(++)]. Primary objective: progression free survival (PFS)

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

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.

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)

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.

A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of AMG 785 in the Treatment of Postmenopausal Women With Osteoporosis

For the overall study period (12-month double-blind alendronate [ALN]-controlled study period followed by the open-label ALN study period) • To assess the effect of AMG 785 treatment for 12 months followed by ALN treatment compared with ALN treatment alone on the subject incidence of clinical fracture (nonvertebral fracture and clinical vertebral fracture) in women with PMO • To assess the effect of AMG 785 treatment for 12 months followed by ALN treatment compared with ALN treatment alone on the subject incidence of new vertebral fracture in women with PMO

The efficacy and safety of adding tocilizumab to methotrexate and intra-articular glucocorticosteroid treatment in early rheumatoid arthritis. A randomized, double-blinded, placebo-controlled trial.

In a multicentre, randomized, two-armed, parallel group, double-blind design in patients with early rheumatoid arthritis to investigate whether it is possible by adding tocilizumab to achieve: 1. Inflammatory control as assessed by number of patients who achieve remission (DAS28<2.6) after 12 months of and 2. Sustained remission (DAS28 < 2.6 for 6 consecutive months) after 12 months of treatment and 3. Radiological control assessed by number of patients without radiological progression of the hands/wrists and upper feet from baseline to 12 months of treatment (Increase in total Sharp score (TSS), joint spacing narrowing (JSN) or joint erosions (JE) > 0.5 units)

A Phase 2 Study of Hsp90 Inhibitor AT13387 Alone or in Combination with Abiraterone Acetate in the Treatment of Castration-Resistant Prostate Cancer (CRPC) no Longer Responding to Abiraterone

Part A: • To assess the safety and tolerability (incidence and severity of adverse events [AEs]) of the combination of AT13387 and abiraterone acetate and to select the most promising treatment regimen for the combination in subjects with castration-resistant prostate cancer (CRPC) who are no longer responding to treatment with abiraterone acetate alone, based on the overall assessment of safety and antitumor activity. Part B: • To assess and compare the antitumor activity (response rate per the Prostate Cancer Working Group 2 [PCWG2] recommendations) between single-agent AT13387 and the combination of AT13387 plus abiraterone acetate in subjects who are no longer responding to treatment with abiraterone acetate alone.

A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination with Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men with Metastatic Castrate Resistant Prostate Cancer

To ascertain whether the survival time distribution for patients randomized to the investigational arm is consistent with longer survival as compared to patients randomized to the control arm

A Phase 3, randomized, double-blind, controlled trial of cabozantinib (XL184) vs. mitoxantrone plus prednisone in men with previously treated symptomatic castration-resistant prostate cancer

The objective of this study is to evaluate the safety and efficacy of cabozantinib compared with mitoxantrone plus prednisone.

Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity (SPACING)

Patients with spondyloarthritis, already treated by TNF blocker (adalimumab, etanercept or infliximab), and in stable low disease activity for at least 6 months, will be randomized into 2 groups: either keeping on their usual treatment with stable doses or progressive spacing of injections of their treatment. Follow-up will be done every 3 months during 12 months, with regular monitoring of disease activity and, in patients from the group "spacing", modification of the rhythm of injections according to health state and predefined protocol.

Safety and efficacy of intramuscular electrotransfer of plasmid AMEP in patients suffering from advanced or metastatic melanoma: an open-label phase I/II clinical trial the AIMM Study (AMEP in metastatic melanoma)

Part 1: Phase I Patients with advanced or metastatic melanoma will receive intramuscularly increasing doses of plasmid AMEP Primary objective: - To determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic melanoma. Part 2: Extension Phase I/II Patients with advanced or metastatic melanoma will receive intramuscularly the recommended dose of plasmid AMEP either alone or in combination with dacarbazine Primary objective: - To confirm the safety and tolerability of intramuscular electrotransferred Plasmid AMEP at the established recommended dose, alone or in combination.

A randomized phase II study of Bevacizumab/mFOLFOX6 vs. Bevacizumab/FOLFIRI with biomarker stratification in patients with previously untreated metastatic colorectal cancer

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

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.

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)

Study to Determine the Efficacy and Safety of AMG 785 in the Treatment of Postmenopausal Women With Osteoporosis

The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis

A Phase II Randomized Open Label Study of MM-121 in combination with Paclitaxel versus Paclitaxel alone in patient with Platinum Resistant/Refractory Advanced Ovarian Cancers.

To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone based on Progression Free Survival (PFS) in advanced ovarian cancers resistant or refractory to platinum agents.

A randomized pilot study comparing the safety of DAbigatran and RIvaroxaban versus NAdroparin in the prevention of venous thromboembolism after knee arthroplasty surgery. DARINA

After total knee arthroplasty (TKA) surgery, patients are at risk to develop venous thromboembolism (VTE). Two novel agents, dabigatran and rivaroxaban, recently gained market authorisation for prevention of venous thromboembolism after knee arthroplasty. Our aim is to compare the long term use of dabigatran and rivaroxaban versus nadroparin on safety after total knee arthroplasty (TKA)

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

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.

A Phase 3 Study with Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects with Chronic Hepatitis C Genotype 1b Infection. Revised Protocol 02 incorporating Protocol Amendments 02 and 03

The purpose of this study is; For prior null or partial responders to P/R cohort: To estimate efficacy, as determined by the proportion of subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive. For treatment naive cohort: To determine whether the SVR12 rate in subjects treated with DUAL therapy is similar to the historical SVR rate for TVR in combination with P/R in previously untreated, genotype 1b, HCV patients.

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.

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)

A Collagen-Fibrin Patch (Tachosil®) for the Prevention of Lymphoceles after Pelvic Lymphadenectomy in Women with Gynecologic Malignancies: a Randomized Clinical Trial

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.

A Randomized, Open-Label, Multicenter Study of the Safety, Efficacy, and Tolerability of Combination Treatment of Setrobuvir, Danoprevir, Ritonavir, and Copegus® with or without Mericitabine in HCV Genotype 1−Infected Patients Who are Either Treatment Naïve or Have Previously Experienced a Null Response to Interferon-Based Treatment

• To evaluate the safety, tolerability and efficacy (SVR-12) of 12 or 24 weeks of treatment with an IFN-free regimen of STV, DNV/r, and RBV, with or without MCB, in treatment-naïve CHC genotype 1 patients. • To evaluate the safety, tolerability and efficacy (SVR-12) of 12 or 24 weeks of treatment with an IFN free regimen of STV, DNV/r, and RBV, with or without MCB, in patients who have previously experienced a null response to interferon-based treatment.

PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma

The PIT (Prophylactic Irradiation of Tracts) trial will determine whether or not PIT radiotherapy is effective in preventing or delaying the onset of chest nodules in patients with Mesothelioma.

A Study of RO5185426 in Patients With Metastatic Melanoma

This open-label, multicenter study will evaluate the safety and efficacy of RO5185426 in patients with BRAF V600 mutation-positive, surgically incurable and unresectable stage IIIC or IV metastatic melanoma. Eligible patients will receive RO5185426 (960 mg twice daily orally) until disease progression or unacceptable toxicity occurs, with a safety follow-up of 24 months after discontinuation of the study drug.

Evaluation of a Standardized Protocol for Dose Reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF Therapy

The purpose of this study is to demonstrate that patients with Spondylarthropathies in remission under antiTNF therapy, can maintain the remission with a maintenance dose inferior to the currently recommended dose schedule.

An open-label multiple dose study to evaluate the pharmacokinetics, safety and tolerability of CP-690,550 in pediatric patients from 2 to less than 18 years of age with Juvenile Idiopathic Arthritis (JIA)

To characterize the PK and safety of CP 690,550 following multiple oral doses in pediatric patients (from 2 to less than 18 years) with active JIA.

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Disease in Subjects with Newly Diagnosed Multiple Myeloma

To determine if denosumab is non-inferior to zoledronic acid with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with multiple myeloma

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

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.

A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease

To evaluate the effect of 8 weeks treatment with AZD3241 on microglia activation as measured by [11C]PBR28 binding to TSPO.

Pro-coagulant Markers and Anticoagulant Failure in Cancer Patients at High-risk for Recurrence of Venous Thromboembolism

The presence of clots in the veins of arms and/or legs or lungs of Cancer patients decreases their quality of life, delays their treatment and may cause death. The best way to avoid new clots is by giving blood thinners before clots are formed, but even some patients who are taking blood thinners may form blood clots. A major problem is that it is difficult to know which patients form clots while they are receiving blood thinners, a situation called treatment failure. Several studies have shown that by doing blood tests that measure the formation of clots, the investigators could know if the patient is responding to the blood thinners. If this is proven, the investigators will be able to apply these tests to all patients

AVAPS-AE Algorithm in Chronic Obstructive Pulmonary Disease (COPD)Patients (AVAPS-AE COPD)

The purpose of this study is to evaluate the performance of AVAPS AE therapy in COPD patients during nocturnal ventilation.

Implementing a Tool to Identify Risk for Venous Thromboembolism in Cancer Patients

Cancer increases the risk of deep vein blood clots and clots traveling to the lungs (emboli) which cause morbidity (leg swelling, pain, and shortness of breath), sudden death, delays cancer treatment, and decreases cancer survival by 66% compared to similar cancer patients without blood clots. Blood thinners may prevent clots but major bleeding is also a problem, so preventive therapies are not used routinely. Identifying patients at highest risk for clots is critical. A tool exists but it has not been used outside of research. We propose to study how to apply this tool in clinical practice and test if it works.

A Prospective, Open-label, Exploratory Study to Investigate the Safety, Efficacy, and Haemodynamics of Lisuride Subcutaneous Infusion as Add-on to Conventional Treatment in Patients with Pulmonary Arterial Hypertension

To investigate the safety of continuous treatment with sc lisuride infusions as add-on treatment to stable conventional therapy in patients with pulmonary arterial hypertension (PAH).

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.

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.

A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

To determine whether the addition of oral MLN9708 to the background therapy of lenalidomide and dexamethasone improves progression-free survival (PFS) in patients with relapsed and/or refractory multiple myeloma (RRMM)

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

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

A Phase II study of the selective BRAF kinase inhibitor GSK2118436 in subjects with advanced non-small cell lung cancer and BRAF mutations

To assess the overall response rate (ORR) in subjects with stage IV or relapsed BRAF V600E mutant non-small cell lung cancer administered GSK2118436 as a single agent.

Efficacy and safety of liraglutide in combination with metformin versus metformin monotherapy on glycaemic control in children and adolescents with type 2 diabetes

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.

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

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.

Study of Nilotinib as First Line Treatment in Philadelphia Chromosome Positive(Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

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.

The Effects of Inorganic Nitrite on cardiac and skeletal muscle: Physiology, Pharmacology and Therapeutic Potential in patients with Chronic Heart Failure

The primary outcome is Peak VO2O2 consumption/workload relation during submaximal exercise.

Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients

Demonstrate the superiority of extended duration (35 days + 7 day window, i.e. 35-42 days allowed) anticoagulation with betrixaban as compared to the standard of care (10 ± 4 days) with enoxaparin for prevention of VTE in patients who are at risk due to acute medical illness

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

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

A randomized, double-blind, placebo controlled, multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate efficacy after twelve weeks of treatment, and to assess the safety, tolerability, usability and long-term efficacy in subjects with chronic plaque-type psoriasis

To demonstrate the efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.

A Phase I/II Dose Escalation Trial Of HDAC Inhibitor Tefinostat (CHR2845) For Cancer Associated Inflammation In Hepatocellular Carcinoma

Phase I: To determine the safety, tolerability and dose-limiting toxicities (DLT) of tefinostat when administered orally to patients with advanced HCC To determine the recommended Phase II dose (RP2D) of tefinostat in patients with advanced HCC Phase II: To perform a preliminary assessment of the anti-disease activity of tefinostat as measured by mRECIST.

Spironolactone to Prevent Cardiovascular Events in Early Stage Chronic Kidney Disease (CKD): A Pilot Trial

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.

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis

To evaluate the long-term safety of mavrilimumab in adult subjects with moderate-to-severe active RA who were previously treated in a qualifying study.

A phase II trial to evaluate safety and efficacy of combined trastuzumab and AUY922 in advanced non-small cell lung cancer (NSCLC) with HER2 - overexpression or - amplification or - mutation.

To evaluate efficacy of combined trastuzumab and AUY922 in HER2 - overexpressed or - amplified or - mutated NSCLC

HERO:Hydroxychloroquine Effectiveness in Reducing Symptoms of hand OA, a randomised, double-blind, placebo-controlled trial

The primary question to be answered by this study is whether hydroxychloroquine is an effective treatment for relieving pain in hand OA.

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.

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

A multi-centre 3-year follow-up study to assess the durability of sustained virologic response in alisporivir treated chronic hepatitis C patients

To assess the durability of sustained virologic response after SVR24 has been achieved in patients treated with alisporivir in a Novartis-sponsored chronic Hepatitis C study.

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)

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).

A Phase II Study of Axitinib in Patients with Metastatic Renal Cell Cancer Unsuitable for Nephrectomy

Does treatment with axitinib stop previously untreated widespread kidney cancer that can't be surgically removed from getting worse for at least 6 months?

A multi-center, randomized, double-blind, parallel group, placebo controlled, study in patients with non-chronic migraine to assess the efficacy, safety and tolerability of BID oral doses of BGG492 in migraine prevention

To assess the efficacy of BGG492 vs. placebo in terms of 50% responder rate (defined by ≥ 50% reduction in attack frequency during the last 4-weeks of the 12-weeks treatment period compared with the 4-weeks Baseline period).

High-dose alkylating chemotherapy in oligo-metastatic breast cancer harboring homologous recombination deficiency

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.

A Phase III randomized trial of metformin versus placebo on recurrence and survival in early stage breast cancer.

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.

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

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.

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)

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.

Lenalidomide and Dexamethasone With/Without Transplant in Patients With Multiple Myeloma

The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will include how many subjects respond to each study treatment combination, how long their responses last, whether they live longer, and what side effects are caused by each combination.

FTO-genotype dependent weight reduction under treatment with bromocriptin in obese patients

Reduction of BMI

Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer

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.

Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Vulva

This phase II trial studies how well giving radiation therapy together with gemcitabine hydrochloride and cisplatin work in treating patients with locally advanced squamous cell carcinoma of the vulva.

A Ph II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety & Immuno. of AGRIPPAL® S1 Vaccine, Formulation 2012-2013, in Non-elderly Adult and Elderly Subjects

Safety Objectives: To evaluate the safety of a single intramuscular (IM) injection of Agrippal in adult and elderly subjects. in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96). Immunogenicity Objectives: Primary To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at approximately 21 days post-immunization in adult and elderly subjects. in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines. Antibodies maybe additionally quantified using the hemagglutination inhibition (HI) test for confirmation purposes (Note for Guidance on Harmonization of Requirements for Influenza Vaccines CPMP/BWP/214/96: 12 March 1997).

A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of FLUAD® Surface Antigen, Inactivated, Adjuvanted with MF59C.1 Influenza Vaccine, Formulation 2012-2013, when Administered to Elderly Subjects

Safety Objectives: To evaluate the safety of a single intramuscular (IM) injection of Fluad in elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96). Immunogenicity Objectives: Primary To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at approximately 21 days post-immunization in elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines. Antibodies maybe additionally quantified using the hemagglutination inhibition (HI) test for confirmation purposes (Note for Guidance on Harmonization of Requirements for Influenza Vaccines CPMP/BWP/214/96: 12 March 1997).

Effects of short-term atorvastatin treatment on prostate cancer - a pre-surgical pilot trial

Reduction of intraprostatic inflammation and inhibition of prostate cancer growth with short-term atorvastatin treatment.

Therapeutic effectiveness, safety and tolerability of Tonsilotren tablets in patients (6 to 60 years old) with chronic tonsillitis. A randomized, international, multicenter, controlled clinical trial.

The primary objective of the study is to assess the therapeutic effectiveness of Tonsilotren in the treatment of chronic tonsillitis when used in addition to conventional symptomatic treatment (test group) in comparison to conventional symptomatic treatment alone (control group).

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)

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.

Safety and Tolerability of Intravenous LFG316 in Wet Age-related Macular Degeneration (AMD).

This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of successive intravenous (IV) doses of LFG316 in eligible patients with neovascular age-related macular degeneration (AMD)

A phase Ib/II open-label, multi-center study of the combination of MEK162 plus AMG 479 (ganitumab) in adult patients with selected advanced solid tumors

Phase Ib: Estimation of Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) by measuring incidence of dose limiting toxicities Phase II: Antitumor activity of MEK162 in combination with AMG 479 by evaluating Objective Response Rate (ORR) in colorectal carcinoma and melanoma and by evaluating Disease Control Rate (DCR) at week 10 in pancreatic carcinoma

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Disease in Subjects with Newly Diagnosed Multiple Myeloma

To determine if denosumab is non-inferior to zoledronic acid with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with multiple myeloma

Diagnosis community-acquired pneumonia in emergency unit

To identify surrogat markes to identify community-acquired pneumonia among adultpatients having lower respiratory tract infection

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

Objective response rate (ORR) and safety

Influence of obesity and gastric bypass on medication absorption: pharmacokinetic study

To evaluate the influence of obesity and a gastric bypass on the absorption of drugs

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy

The primary objective of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in reducing the signs and symptoms of disease in subjects with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and CNTO 1959 in this population.

Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma

This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have disease progression within 6 months prior to study enrolment following standard therapies which must have included an anthracycline, unless contraindicated and then at least one additional regimen after failure of the anthracycline.

Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients

Demonstrate the superiority of extended duration (35 days + 7 day window, i.e. 35-42 days allowed) anticoagulation with betrixaban as compared to the standard of care (10 ± 4 days) with enoxaparin for prevention of VTE in patients who are at risk due to acute medical illness

A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension

To evaluate the long-term safety and tolerability of the pediatric formulation of bosentan at a dose of 2 mg/kg b.i.d. in children with pulmonary arterial hypertension (PAH).

A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma

To compare progression-free survival (PFS) in patients with multiple myeloma relapsed after 1 to 3 prior therapies treated with either carfilzomib plus dexamethasone (Cd) or bortezomib (Velcade®) plus dexamethasone (Vd).

A randomised, double blind, placebo controlled trial to evaluate the effect of Rivastigmine on gait in people with Parkinson’s disease who have fallen.

This study seeks to assess the benefit of rivastigmine (a drug which augments mental function) on gait (walking) dysfunction in patients with Parkinson’s disease (PD) with a past history of a fall. The primary aim is to determine the effect of the cholinesterase inhibitor (ChEi) rivastigmine on step time variability in patients with PD. Step time variability is a marker of how stable an individual's walking is and a prognostic marker for future falls risk.

Ketamine augmentation of ECT to improve outcomes in depression

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)

A Placebo-Controlled, Randomised, Double-Blind Trial to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via Convection Enhanced Delivery (CED) in Subjects with Parkinson’s Disease

To assess the effect of q2 weekly intermittent bilateral intraputamenal GDNF infusions on OFF-state motor function at 9 months.

Phase II Study of ADI-PEG 20 in Patients with Relapsed Sensitive or Refractory Small Cell Lung Cancer

To determine whether treatment with ADI-PEG 20 will shrink small cell lung cancer.

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

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).

Ganetespib With Pemetrexed-cisplatin, in Patients With Malignant Pleural Mesothelioma (MESO-02)

Malignant pleural mesothelioma (MPM) is a rapidly lethal cancer arising from the parietal pleural mesothelium, and is associated with exposure to asbestos. Once a rare disease, it is increasing in incidence in the UK and is presently more common than cervical cancer. MPM is characterized by local invasion of adjacent structures including the chest wall, mediastinum, diaphragm and pericardium resulting in progressive shortness of breath. Median survival with best supportive care alone is approximately 6-9 months and most cases of mesothelioma present in the advanced setting. Therefore this trial will be looking at whether a new drug, Ganetespib has any improvement on survival for these types of patients.

The effect of intravenous glucocorticoids on the tearfilm in eyes with thyroid-associated ophthalmopathy

To assess the change in tear film thickness in eyes with thyroid-associated ophthalmopathy treated with intravenous glucocorticoids

Proton Beam Radiation Therapy for Intraocular and Periocular Retinoblastoma

The purpose of this trial is to evaluate proton beam radiation therapy as an alternative to external photon beam irradiation in children with retinoblastoma as a means of local tumor control and ocular retention.

EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies

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)

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.

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

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.

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

To determine if 6 cycles of paclitaxel and carboplatin plus AMG 386 followed by 18 months of AMG 386 maintenance improves progression-free survival (PFS) compared to 6 cycles of paclitaxel and carboplatin plus AMG 386 placebo followed by 18 months of AMG 386 placebo maintenance in the first-line treatment of subjects with FIGO Stage III-IV epithelial ovarian, primary peritoneal or fallopian tube cancers

An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease

To assess the objective response rates (ORR) for 150 mg and 300 mg/day of vandetanib in patients with advanced & progressive MTC. ORR = % of patients with a best response of complete or partial response (CR/PR) as per RECIST Version1.1

A phase II, randomized, controlled, partially-blind study to demonstrate immunogenicity and assess safety of GlaxoSmithKline (GSK) Biologicals’ pneumococcal vaccines (2830929A and 2830930A) administered as a 3-dose primary vaccination course during the first 6 months of life and as a booster dose at 12-15 months of age.

• To demonstrate that 2830929A vaccine co-administered with DTPa-HBV-IPV/Hib as a three-dose primary vaccination course at approximately 2, 3, 4 months of age is non-inferior to Prevenar 13 or Synflorix in terms of percentage of subjects with antibody concentrations greater or equal to the seropositivity threshold AND in terms of ELISA Geometric Mean Concentrations (GMCs). • To demonstrate that 2830930A vaccine co-administered with DTPa-HBV-IPV/Hib at approximately 2, 3, 4 months of age is non-inferior to Prevenar 13 or Synflorix in terms of percentage of subjects with antibody concentrations greater or equal to the seropositivity threshold AND in terms of ELISA GMCs.

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

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

Arteos II Study: Relationship Between Osteoporosis and Arterial Rigidity Within Fractured Patients Cohort (ARTEOS2)

The investigators planned to study relationship between osteoporosis and arterial rigidity within fractured patients cohort.

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

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

A phase 2a, double-blind, placebo-controlled study of TCN-032 (human monoclonal antibody directed against the M2 protein of Influenza A Virus) in subjects challenged with H3N2 Influenza A Virus

The primary objective is to evaluate the effect of TCN-032 compared to placebo in the development of influenza symptoms Grade 2 or higher, or pyrexia, from Day 1 to Day 7, after viral challenge.

Diagnosing Thyroid Cancer Using a Blood Test

Thyroid cancer is a relatively rare disease but its incidence is increasing in many countries.. Early and accurate diagnosis leading to earlier treatment and intervention is recognised as a major factor in determining a good outcomes. This study will investigate new ways of diagnosing thyroid cancer from blood samples using proteomic and genetic markers. The study will take samples from patients with differentiated thyroid cancer and measure relative quantities of 1000s of proteins within the blood. These measures will be explored to see if, when used in combination they can accurately diagnose thyroid cancer. If successful this technique could be extended to routine screening and could replace more invasive tests currently used. Participants will be required to supply a small sample of blood, answer questions on their medical history and also consent for their medical records to be examined. A lifestyle questionnaire will also be supplied to each participant. In the case where a diagnosis is predicted for a condition the participant was not aware of the medical team will discuss the best interests of the patient with their GP and if required refer them to a suitable specialist. The study will run for 24 months and will routinely process around 15 and 20 participants with a history of thyroid cancer per month. All patient details will be kept confidential and only non identifiable information will leave the clinic. The work will be published and if successful will be validated on another site, commercialised and made available for routine clinical use.

A phase III, randomised, open-label study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to the BRAF inhibitor vemurafenib in subjects with unresectable (stage IIIc) or metastatic (stage IV) BRAF V600E/K mutation positive cutaneous melanoma

To establish the superiority of dabrafenib and trametinib combination therapy with vemurafenib monotherapy with respect to overall survival (OS) for subjects with advanced/metastatic BRAF V600E/K mutation-positive cutaneous melanoma.

Treatment of osteopenia with melatonin: Effects on BMD, muscle strength and quality of life

The aim of the study is to assess the effect of melatonin treatment in patients with osteopenia on BMD, muscle function, quality of life and calcium homeostasis.

FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema

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.

Efficacy and Safety of an Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence: A Placebo Controlled, Randomized, Double-blinded Parallel-Group Comparison for Superiority

To prove the superiority of Otovowen to placebo in the prevention of acute otitis media

Palliative Care in Heart Failure (PAL-HF)

The primary aim of the PAL-HF trial is to assess the impact of an interdisciplinary palliative care intervention combined with usual heart failure management on health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale.

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

• 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

Pharmacokinetics of intravenous acetaminophen and its metabolites in morbidly obese patients

To study the pharmacokinetics of acetaminophen and metabolites in morbidly obese patients and compare with normal weight patients.

MelaViD: A Trial on Vitamin D Supplementation for Resected Stage II Melanoma Patients

The purpose of this trial is to assess the effect of vitamin D supplementation on recurrence in resected stage II melanoma patients.

Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis (POSTURE)

Apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.

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

To evaluate the efficacy of ivacaftor in subjects with cystic fibrosis (CF) who have the R117H-CF transmembrane conductance regulator (CFTR) mutation

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

To evaluate the safety of long-term ivacaftor treatment in subjects with cystic fibrosis (CF)

A Phase 3, Open-Label Study with Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin with Chronic Hepatitis C Genotypes 1 or 4 Infection + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 13-Mar-12) Revised Protocol 01 incorporating Protocol Amendment 02 dated 31-May-2012

To assess efficacy, as determined by the proportion of subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12.

A Phase 3bMulticenter, Open-label Abiraterone Acetate Long-term Safety Study

To collect follow-up safety data from patients in completed abiraterone acetate studies. Consideration will be given to extending the duration of the study following review of the safety data at 3 years.

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

• 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)

Effect of Ranolazine in Heart Failure Patients with Preserved Ejection Fraction

The primary objective is to demonstrate that ranolazine treatment results in a placebo corrected improvement in the 6-minute walk test (6MWT) after 28 weeks of treatment

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

-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

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

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).

Phase II multicenter single-arm study evaluating the safety and efficacy of everolimus as a first-line treatment in newly-diagnosed patients with advanced GI neuroendocrine tumors.

To evaluate 15month progression-free survival rate (15month PFS rate) (according to RECIST 1.1) in newly-diagnosed patients with advanced or unresectable GI and pancreatic neuroendocrine tumors treated with everolimus as a first-line treatment.

A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying

To measure the effect of co-administration of GSK962040 on levodopa pharmacokinetic exposure in subjects with Parkinson’s disease with delayed gastric emptying

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?

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

Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab plus Etoposide/Platinum versus Etoposide/Platinum in Subjects with Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) Revised Protocol 01 incorporating administrative letter 04 and protocol amendment 04 (dated 09-Feb-2012)

To compare overall survival (OS) of subjects randomized to ipilimumab in addition to platinum and etoposide (Arm A) to that of subjects randomized to placebo in addition to platinum and etoposide (Arm B) in subjects with newly diagnosed extensive stage SCLC.

QUTENZA versus pregabalin in subjects with peripheral neuropathic pain: an open-label, randomized, multicenter, noninferiority efficacy and tolerability study

To compare the efficacy of QUTENZA versus pregabalin in subjects with peripheral neuropathic pain (PNP) after 8 weeks

Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma

The primary purpose of this study is to evaluate the efficacy of PAD-regimen and TAD-regimen in newly diagnosed multiple myeloma(MM).

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

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.

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

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).

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

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.

Study to Reduce Duration of Antibiotic Therapy in Haematological Patients With Fever and Neutropenia (HOWLONG)

Clinical trial intended to reduce the antibiotic therapy duration in "in-hospital" patients with haematological diseases who develop fever and low white blood cell count (neutropenia).

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

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.

A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate Efficacy of a Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in subjects with Gastroesophageal Reflux Disease (GERD) with Persistent Regurgitation With or Without Heartburn.

To evaluate the effect of 3 doses of SSP-002358 on the symptom of regurgitation compared with placebo

A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Febuxostat Compared to Febuxostat Alone at Lowering Serum Uric Acid and Resolving Tophi in Subjects with Tophaceous Gout

To determine the efficacy of lesinurad by Month 6 when used in combination with febuxostat compared to febuxostat monotherapy

New Adjuvant Chemotherapy of Non Resectable Liver Metastasis of Colorectal Cancer Without Bleeding, Obstruction

Evaluation of new adjuvant chemotherapy for unresectable liver metastasis of colorectal cancer without bleeding, obstruction, etc.

Acute Upper Respiratory Tract Infection - When is Bacteria Involved?

The purpose of this study is to find out if we can predict the progress of acute upper respiratory tract infection to acute bacterial rhinosinusitis in Finnish conscripts by symptoms, clinical, endoscopic or radiological findings, middle meatal swab samples or nitric oxide measurement.

An exploratory, randomized, double blind, placebo controlled, parallel groups Phase II clinical trial to evaluate the efficacy and safety of E-52862 (400 mg) by oral route, in patients with painful diabetic neuropathy.

The primary objective of this study is to assess the analgesic efficacy of E-52862 in subjects with moderate to severe painful diabetic neuropathy.

A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis

To evaluate the efficacy of apremilast 30 mg twice a day (BID), compared with placebo, in the reduction of signs and symptoms in subjects with active AS at 16 weeks of treatment

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

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.

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

Comparison of disease-free survival

Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients

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.

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

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).

A Phase III, randomized, double-blinded study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to dabrafenib and placebo as first-line therapy in subjects with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma

To establish the superiority of dabrafenib and trametinib combination therapy over dabrafenib and trametinib placebo (dabrafenib monotherapy) with respect to progression-free survival (PFS) for subjects with advanced/metastatic BRAF V600E/K mutation-positive cutaneous melanoma.

A Randomized, Open-Label, Phase 3 Trial of brentuximab vedotin (SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma

To determine ORR, lasting at least 4 months, with brentuximab vedotin in patients with CD30+ MF or pcALCL compared to that achieved with therapy in the control arm

A 1-week, open-label, multi-center study to explore conduction abnormalities during first dose administration of fingolimod in patients with relapsing-remitting multiple sclerosis (START)

To evaluate the incidence of patients with bradycardia (heart rate < 40 beats per min) and bradyarrhythmic ECG events during 6-hour monitoring period as measured by heart rate and second and third-degree AV blocks after treatment initiation of fingolimod 0.5 mg.

A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer

The endpoint is to investigate if the addition of low molecular heparin - enoxaparin, will result in a significant increase of overall survival in patients with small cell lung cancer, receiving standard chemotherapy.

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

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.

Evaluation of the efficacy of memantine in the treatment of fibromyalgia: a double-blind randomized control clinical trial.

To evaluate the efficacy of memantine in the treatment of pain

Effect of V0251 in Acute Vertigo

Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.

A double-blind, placebo-controlled, multicenter, parallel group study to assess efficacy, safety and tolerability of TC-5619 as augmentation therapy to improve negative symptoms and cognition in outpatients with schizophrenia

To assess the efficacy of TC-5619 to improve negative symptoms and cognition when used as augmentation therapy to atypical antipsychotics in stable outpatients with schizophrenia

A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.

To evaluate the efficacy of mavrilimumab in subjects with moderate-to-severe adult onset RA.

Molecular Analysis of Retinoblastoma

The objective of this protocol is to begin to identify the mutations and gene expression changes that occur in retinoblastoma cells following RB1 gene inactivation in order to more effectively target chemotherapy for treating bilateral retinoblastoma.

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

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.

Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration

The purpose of this study is to determine the efficacy, safety and tolerability of multiple doses of RN6G in subjects with Geographic Atrophy Secondary to Age-related Macular Degeneration.

A Phase 2, Open-Label, Single-Arm, Multidose Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer

To evaluate the effects of orteronel, when administered with prednisone, on the QT/QTc interval in patients with metastatic castration-resistant prostate cancer (mCRPC)

A Phase 1/2 Study to Evaluate the Safety, Tolerability, Immune Response, and Clinical Efficacy of Cancer Peptide Vaccine S-488210 in Patients with Unresectable Locoregionally Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Phase 1 part: To evaluate the safety and tolerability of S-488210 in HLA A*02:01-positive patients with head and neck squamous cell carcinoma (HNSCC) receiving 4 vaccinations of S-488210 Phase 2 part: To compare the overall survival between HLA-A*02:01-positive and HLA-A*02:01-negative patients receiving S-488210

CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib

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

rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors

This is multicenter, open-label, randomized, active-controled, phase IV study of local direct intra-tumor injection of rAd-p53 monotherapy, with concurrent radioactive iodine , or combination with surgery for treatment of advanced malignant thyroid tumors.

Prospective, open-label, non-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of octagam 10% in primary immune thrombocytopenia

To assess the efficacy of Octagam 10% in correcting the platelet count (PC).

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.

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.

Molecular Biomarkers for Colorectal Liver Metastases Resectability after Chemotherapy with Cetuximab

Complete liver resection after chemotherapy

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)

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.

A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

The primary objective in the glucocorticoid-continuing subpopulation of men and women treated with chronic glucocorticoid therapy is to demonstrate that treatment with denosumab 60 mg subcutaneously (SC) every 6 months (Q6M) is not inferior to treatment with oral risedronate 5 mg every day (QD) with respect to the percent change from baseline in lumbar spine bone mineral density (BMD) by dual X-ray absorptiometry (DXA) at 12 months. The primary objective in the glucocorticoid-initiating subpopulation of men and women treated with glucocorticoid therapy is to demonstrate that treatment with denosumab 60 mg SC Q6M is not inferior to treatment with oral risedronate 5 mg QD with respect to the percent change from baseline in lumbar spine BMD by DXA at 12 months.

Multicenter phase 1/2a study using T-cell receptor gene therapy in metastatic melanoma

To study the efficacy of this treatment strategy in inducing tumor-specific T cell immunity as measured by the presence of Mart-1 specific T cells in peripheral blood samples on several time points following adoptive transfer.

A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase 2/3 Study of LY2127399 in Combination with Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma

The primary objective of Phase 2 is to select a dose of LY2127399 to assess with bortezomib and dexamethasone in Phase 3. The primary objective of Phase 3 is to compare PFS after treatment with the dose of LY2127399 selected in Phase 2, bortezomib, and dexamethasone, to that of placebo, bortezomib, and dexamethasone in patients with relapsed/refractory MM.

A phase II window-of-opportunity study of preoperative therapy with pazopanib (votrient®) in high-risk soft tissue sarcoma

To evaluate whether neoadjuvant treatment with pazopanib in patients with soft-tissue sarcoma has therapeutic effects, measured as metabolic response.

Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma

The Purpose of this trial is: to determine complete response rate (CRR) after six cycles of chemotherapy to determine complete remission rate (CR/CRr) as final treatment outcome after completion of treatment

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

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.

The effect of treatment of traumatised refugees with Traume-Focused Cognitive Behavioural Therapy and antidepressants - a randomised controlled clinical trial.

To evaluate the treatment effect of pharmacotherapy with Mianserine and Sertraline and trauma-focused cognitive behavioural therapy in traumatised refugees

A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg vs at 10 mg/kg in Subjects with Previously Treated or Untreated Unresectable or Metastatic Melanoma Revised Protocol 02 incorporating Protocol Amendments 05 and 09 + Pharmacogenetics Blood Sample Amendment- Site Specific (version 1.0 dated 10-Nov-11) + Protocol Amendment 03- Site Specific (version 1.0 dated 09-nov-2011) + Protocol Amendment 07- Site Specific (version 1.0 dated 21-mar-2012) + Biomarker Sub-Study Protocol amendment 06 version 1.0, dated 29-May-2012- Site-specific

The purpose of this study is to determine whether giving ipilimumab at a dose of 10 mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving ipilimumab at a dose of 3 mg/kg

NAPOLI 1: A Randomized, Open Label Phase 3 Study of MM-398 versus 5- Fluorouracil and Leucovorin in Patients with Metastatic Pancreatic Cancer

To compare overall survival following treatment with MM-398 versus 5-fluorouracil and leucovorin in patients with metastatic pancreatic cancer that have progressed on gemcitabine based therapy.

An Open-label Study of Sipuleucel-T in European Men with Metastatic, Castrate Resistant Prostate Cancer

The purpose of the study is to demonstrate that sipuleucel-T can be successfully manufactured at a European manufacturing facility. Sipuleucel-T (Provenge®) is approved for use in the US by the Food and Drug Administration for the treatment of metastatic castrate resistant prostate cancer. The study sponsor, Dendreon Corporation is applying for Manufacturing Authorization in Europe. The intent of this study is to demonstrate that sipuleucel-T manufactured in Europe results in the same cellular activation as seen in sipuleucel-T produced in the US.

A open-label extension study of CP-690,550 as maintenance therapy in patients with crohn’s disease

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.

The treatment of traumatized refugees with Setraline versus Venlafaxine - a randomized trial.

To investigate whether or not there is a difference in the treament effect of Venlafaxine and Sertraline on PTSD symptoms in traumatized refugees.

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

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.

An Open-label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination with Bortezomib and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma

To establish the safety profile of daratumumab when given in combination with bortezomib and dexamethasone in subjects with relapsed or refractory MM

Hellenic Anglo Research into Morning Or Night antihypertensive drug deliverY trial.

To detect if there is a 3mm Hg difference in average 24 hour systolic blood pressure when blood pressure lowering medications are taken in the evening compared with same medications taken in the morning.

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

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.

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

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.

An open-label phase IIIb study of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy

To provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed all approved standard therapies and to assess the safety of regorafenib

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis

To evaluate the change in disease activity following intravenous (i.v.) administration of two doses of NNC0114-0006 compared to placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy

Intra-arterial Chemotherapy With Melphalan for the Treatment of Retinoblastoma (RTB) in Advanced Intraocular Stage

For selected cases with advanced Retinoblastoma (RTB) intraocular involvement(stage V of the Reese-Ellsworth classification) in which enucleation would usually be the standard therapeutic approach, in this project the investigators propose an alternative conservative treatment using intra-arterial chemotherapy with melphalan, via direct administration by catheterization of the ophthalmic artery.

Pharmacokinetics of micafungin during continuous venovenous hemofiltration

Measuring pharmakokinetecs of micafungin during continuous renal replacement therapy

Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer

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.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients with Moderate-to-Severe Plaque Psoriasis

Efficacy of ixekizumab vs. etanercept in subjects with moderate to severe chronic plaque psoriasis based on sPGA and PASI at 12 weeks.

A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis

The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 capsules containing either 45 mg DM and 10 mg Q (AVP-923-45) or 30 mg DM 10 mg Q (AVP-923-30) or 20 mg DM and 10 mg Q (AVP-923-20) compared to placebo, for the treatment of central neuropathic pain in a population of patients with multiple sclerosis (MS) over a 12-week period.

A multi centre, double blind, randomised, placebo controlled crossover study to evaluate the efficacy and tolerability of picotamide in the prophylaxis of migraine in patients presenting with migraine with aura

To investigate the efficacy of picotamide compared to placebo in the reduction of the number of auras in patients with migraine with aura

A Phase II Trial to Assess TroVax® Plus Chemotherapy in Patients With Malignant Pleural Mesothelioma (SKOPOS)

This study is for patients with malignant mesothelioma of the lung lining (called pleura) who are planning to have pemetrexed-cisplatin chemotherapy. We are investigating whether giving a vaccine called TroVax® with pemetrexed-cisplatin chemotherapy is both safe and potentially beneficial in patients with mesothelioma. This vaccine has been used in combination with chemotherapy in other types of cancer and has been shown to be safe. Cancer vaccines work by stimulating the person's immune system to fight the disease, in a similar way to the immune system fighting infection. In laboratory experiments, the vaccine has been shown to stimulate an immune response to a particular protein widely found on mesothelioma cells called 5T4. In patients with mesothelioma it is hoped that the vaccine will stimulate the immune system to attack mesothelioma cells carrying the 5T4 protein.

A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy

The primary objectives are to assess the safety, tolerability, and efficacy (change from baseline in Disease Activity Score 28 [DAS28] using C-reactive protein [CRP]) of JNJ-40346527 200 mg/day (100 mg twice daily) for 12 weeks compared with placebo in subjects with active RA despite DMARD therapy.

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)

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.

Evaluation of the efficacy of sildenafil on the functional capacity of patients with heart failure with preserved ejection fraction. A randomized, double blind, parallel group and placebo-controlled clinical trial.

To demonstrate an increase in the total distance walked in the six-minute walk test after 12 weeks of treatment with Sildenafil in patients with HFpEF.

Medication Adherence in Individuals With Epilepsy

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.

A randomized study with Cisplatinum or Cetuximab and standard or adaptive high dose radiotherapy for advanced head and neck cancer.

To determine the predictive value of median Cetuximab uptake for response to concomitant Cisplatinum or Cetixumab together with radiation

A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects with Schizophrenia

To demonstrate, in patients stabilized on the paliperidone palmitate 1 month formulation (PP1M), that paliperidone palmitate 3 month formulation (PP3M) is not less effective than PP1M in the treatment of symptoms of schizophrenia, based on the Kaplan-Meier 48-week cumulative estimate of survival (ie, percentage of subjects remaining relapse free).

Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls

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.

Boosting oxytocin after trauma: The effects of intranasal oxytocin administration on emotional and motivational brain processes in PTSD

In this functional Magnetic Resonance Imaging (fMRI) study, the primary objective is to examine the acute effects of intranasal OT administration on emotional- and reward-related brain processes in PTSD patients compared to traumatized healthy controls. Furthermore, we aim to examine gender differences in the effects of intranasal OT administration on functional (task-specific) brain activation and in structural anatomy (i.e. volume and white matter integrity) between PTSD patients and traumatized healthy controls.

Neuro-Music Therapy for Recent Onset Tinnitus: Evaluation of a Therapy Concept

To date, the pharmacological treatment options for tinnitus are unsatisfactory. For acute tinnitus drug treatments are only rated as being successful in approximately half of all cases. Therefore, the purpose of this study is to evaluate a neuro-music therapeutic approach (the "Heidelberg Model of Music Therapy") as a new treatment option for patients with recent onset tinnitus after initial medical treatment has failed.

A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia

The main objective of this study is to investigate the safety, pharmacokinetics (PK) and the relationship between PK and pharmacodynamics (Minimum Inhibitory Concentration [MIC] and Mutant Prevention Concentration [MPC]) of intravenous BAYQ3939 (400 mg BID and 400 mg TID) in hospitalized patients with severe pneumonia or patients who did not respond to other antibiotics used for the treatment of bacterial pneumonia. In addition, the efficacy of the ciprofloxacin, in terms of clinical response and microbiological response, will be investigated, but as a secondary endpoint.

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

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.

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

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.

A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis

The primary objective of the study is to assess the effect of tralokinumab compared with placebo in patients with active UC by assessment of clinical response, as defined by the Mayo score, at week 8.

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms