Clinical Trials

The Effect of Cancer Therapies and Exercise on Mitochondrial Energetics and Fitness

The present study is a randomised control trial investigating the effects of a short six week exercise training program in rectal cancer patients following neoadjuvant chemoradiotherapy prior to elective rectal cancer surgery.

Randomized Study Comparing Different Chemotherapy + Immune Therapy on the Pathological Response on Metastases From Colorectal Cancer

Patient who's suffering from colorectal cancer with resectable metastases are invited to participate at this study. As often it is realized actually the treatment will be chemotherapy (FOLFOX or FOLFIRI) combining with Bevacizumab, before the resection of their metastases. The goal of the study is to demonstrate the superiority of combining FOLFOX + Bevacizumab comparing FOLFIRI + Bevacizumab for the pathological response on the resected metastases. Actually the pathological response of the metastases after chemotherapy is a validated prognostic tool. All the chemotherapy treatments are proved they efficacy in the field of metastatic colorectal cancer, and they are reimbursed in this indication. The study wants to demonstrate the best association with Bevacizumab in the way of pathological response. They will be two group of patient (Randomized, open label study), one of these will received Bevacizumab + FOLFOX and the other one will received Bevacizumab + FOLFIRI. Patients of the 2 groups will be treating surgically as define in the protocol and on the MD indication. A post operative follow up will be realised to observe the progression free survival (PFS) and the overall survival (OS). A translational research will be process also, but only in a few patients, to try to characterize other predictive or prognosis factors. The study will open the recruiting period during 3 years and one more year for the follow up period. Since the patient signed his informed consent, he will randomized and reach one of the 2 arms. The screening period must be under 29 days and than there is the inclusion visit. After the inclusion visit he begin the cycle 1 to 6 before surgery, according his randomized arm. After 6 cycles the surgery will process and than there is a post-operative period begin. During this post operative period, he's able to receive more chemotherapy and/or target therapy at the discretion of the local investigator. The operative period correspond of the primary end point because of the metastases resection. After 3 month of post operative period he begin the follow-up period who's approximatively of 30 months.

Degarelix Before Radical Prostatectomy

The biological effects of castration on prostate cancers will be studies by administration of degarelix prior to radical prostatectomy. The effects will be studied by analysis of gene expression and immunohistochemistry focusing on markers of proliferation and apoptosis of samples taken at the time of radical prostatectomy (7-14 days after administration of degarelix). Tumours from patients treated with neo-adjuvant degarelix will be compared with tumours from patients who have not been medically castrated.

A Study Of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This multicenter, single-arm study will evaluate the efficacy and safety of MPDL3280A in patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients will receive an intravenous dose of 1200 mg MPDL3280A on Day 1 of 21-day cycles for a maximum of 16 cycles.

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.

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.

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.

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.

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.

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.

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

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.

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).

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.

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.

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.

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).

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.

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 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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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%.

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.

Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery (IMAGER)

The investigators hypothesize that the rate of radiologically complete resections of contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to surgeries aided by 5-ALA induced fluorescene alone.

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

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

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.

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

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

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.

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.

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)

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.

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.

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)

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.

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.

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 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.

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

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.

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.

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.

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.

Congenital Transmission of Lineages I and II of Trypanosoma Cruzi

T. cruzi has been divided into two main lineages: T. cruzi I (TcI) and T. cruzi II (TcII, including all non-TcI). TcI is predominant in Mexico and Central America, while TcII (non-TcI) is predominant in most of South America, including Argentina. In recent studies from Argentina, the risk of congenital transmission has been estimated to vary between 2.6 percent and 7.9 percent. By contrast, we know very little about the congenital transmission of TcI. It has been suggested that congenital transmission of T. cruzi is strain related, and there is an urgent need to know if TcI transmits differently than TcII (non-TcI). Our primary hypothesis is that congenital transmission rates are different for TcI versus TcII. Our secondary hypothesis is that the characteristics of T. cruzi infected mothers (e.g., age, parity, transmission in previous pregnancies) and their exposure to vectors are different in regions where TcI is predominant versus regions where TcII (non-TcI) is predominant. To test these hypotheses, we propose to conduct a prospective study to enroll at delivery 13,000 women in Mexico, 7,500 women in Honduras, and 10,000 women in Argentina. We will measure transmitted maternal T. cruzi antibodies in cord blood, and, if the results are positive, we will identify infants who are congenitally infected by performing parasitological examinations on cord blood and at 4-8 weeks, and serological follow-up at 10 months. We will also perform standard PCR, real-time quantitative PCR, and T. cruzi genotyping on maternal blood, standard PCR and T. cruzi genotyping on the cord blood of congenitally infected newborns, and serological examinations on siblings. We will estimate the exposure to vectors in the household. In addition, we will measure prenatal outcomes among infected and uninfected infants with seropositive mothers, and the birth weight of their siblings. The specific aims of this study are: 1) To determine the rate of congenital transmission of TcI compared to TcII (non-TcI); 2) To compare the T. cruzi infected mothers' characteristics and exposure to vectors in regions where TcI is predominant and regions where TcII (non-TcI) is predominant; and 3) To describe the birth outcomes of infected and uninfected infants born to TcI and TcII seropositive women.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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 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.

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.

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.

An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184

This is an adaptive, dose ranging, Phase II study to investigate the relationship between repeat doses of GSK2586184 and the pharmacodynamic effect and clinical efficacy in patients with active systemic lupus erythematosus (SLE). This study will also investigate the safety and tolerability of repeat doses of GSK2586184.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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

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.

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.

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.

iMRI-guided Brain Biopsies

The aim of the study was to assess the safety and effectiveness of stereotactic brain tumour biopsy (STx biopsy) guided by low-field intraoperative MRI (iMRI) in comparison with its frameless classic analogue based on a prospective randomized trial.

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.

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.

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.

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.

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

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.

Study Comparing AEZS-108 to Doxorubicin as a Second Line Therapy of Endometrial Cancer

Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin. The study will include about 500 patients with endometrial cancer resistant to platinum/taxane-based chemotherapy.

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.

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.

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.

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.

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.

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.

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.

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)

Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus

To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

Treatment of antipsychotic associated obesity with a GLP-1 Analogue: the TAO study

To investigate if 3 months treatment with a GLP-1-analogue can reduce antipsychotic associated obesity in non-diabetic patients with a diagnosis within the schizophrenic spectrum

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 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.

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.

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.

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.

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 Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus

To evaluate the efficacy of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active SLE with an inadequate response to SOC SLE at Day 169 (Week 24).

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 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.

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 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)

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 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

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 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.

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

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.

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.

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.

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 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.

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.

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.

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)

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.

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

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.

An adaptive, placebo-controlled, Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with mild to moderate systemic lupus erythematosus.

• To estimate the relationship between dose of GSK2586184 and pharmacodynamic effect on expression of selected messenger ribonucleic acid (mRNA) transcripts following 2 weeks of treatment in SLE patients • To estimate the relationship between dose of GSK2586184 and clinical response as assessed by SELENA SLEDAI score following 12 weeks of treatment in SLE patients • To evaluate the safety and tolerability of repeat doses of GSK2586184 in SLE patients.

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.

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 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).

A prospective randomised controlled phase II/III clinical trial of rivaroxaban versus warfarin in patients with thrombotic antiphospholipid syndrome, with or without SLE.

The primary aim of the trial is to assess whether the anticoagulant effects of rivaroxaban are not inferior to those of warfarin. This will be achieved by comparing the percentage change in endogenous thrombin potential (ETP), assessed by the thrombin generation test (TGT), from randomisation to day 42. The TGT is a global measure of anticoagulation, which can assess the anticoagulant effects of both rivaroxaban and warfarin (drugs with very different modes of action on the coagulation mechanism). The TGTs will be performed in the UCL Haemostasis Research Unit.

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

Effect of fingolimod on cardiac autonomic regulation in MS-patients

To evaluate whether fingolimod has an effect on the heart rate variability or myocardial ventricular repolarisation in patients with multiple sclerosis?

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.

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.

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.

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

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 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).

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 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.

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

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

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.

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

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.

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

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 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.

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.

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)

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 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 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

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.

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.

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.

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

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 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)

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.

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.

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).

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.

Evolution of serologic biomarkers and diastolic function and segmentary contractility determined by echocardiography after treatment in Chagas diseases

Chagas disease (CD), caused by Trypanosoma cruzi, is endemic to Latin America, and is of emerging importance in non-endemic countries because migration of people infected with T. cruzi. Current methods for diagnosis of T. cruzi infection are not ideal. Existing drugs for treatment are very limited, produce severe side-effects, and their effectiveness cannot be properly evaluated. Reliable biomarkers for prognosis, early diagnosis and effectiveness of treatment will be investigated.

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

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 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).

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.

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.

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.

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.

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

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.

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

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 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

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.

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.

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 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 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 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).

Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer (TOMOGYN)

Comparison of radiotherapy tolerance (two types of radiotherapy) for patients over 70 years with a endometrial cancer.

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

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.

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.

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

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.

A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus

To evaluate the efficacy of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active SLE with an inadequate response to SOC SLE at Day 169 (Week 24).

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

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.

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 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 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.

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.

An open, prospective, single arm study investigating efficacy and safety of human hepatitis B immunoglobulin Zutectra in liver transplanted patients - the ZEUS Study

To investigate the efficacy of Zutectra in orthotopic liver transplanted 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.

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.

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.

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

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).

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.

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.

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

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.

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.

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.

The Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas

This is a Phase III study about the effects of the addition of polychemotherapy to adjuvant radiotherapy in the treatment of non-metastatic uterine sarcomas.

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 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)

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 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 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.

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.

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

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.

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

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?

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.

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.

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.

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.

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

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

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 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).

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.

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.

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 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 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

An Open-Label Study to Explore the Clinical Efficacy of GS-7977 with Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant

The primary objective of this study is to determine if the administration of a combination of GS-7977 and ribavirin to HCV-infected subjects with hepatocellular carcinoma (HCC) meeting the MILAN criteria prior to undergoing liver transplantation for up to 24 weeks can prevent post-transplant reinfection as determined by a sustained post-transplant virological response (HCV RNA

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.

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.

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 Survivorship Care Plan for Gynaecological Cancer Patients

The primary objective of this study is to determine if there is any additional benefit, over usual rehabilitation care, of additional rehabilitation appointments to develop a survivorship care plan on cancer specific health related quality of life.

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.

A phase II, open-label, single-arm, non-randomized, multi-center study to evaluate the efficacy of oral TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer

To assess the antitumor activity of TKI258, as measured by an 18-week progression free survival (PFS) rate, in patients with pre-treated endometrial cancer, with or without FGFR2 mutation.

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 Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE)

• To evaluate the efficacy of belimumab administered SC in adult subjects with SLE. • To evaluate the safety and tolerability of belimumab administered SC in adult subjects with SLE.

A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE)

• Evaluate the safety and tolerability of belimumab in the pediatric SLE population • Evaluate the pharmacokinetics of belimumab in the pediatric SLE population. • Evaluate the efficacy of belimumab in the pediatric SLE population • Evaluate the effects of belimumab on the quality of life in the pediatric SLE population.

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.

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

Study to evaluate the efficacy and safety of Anakinra in the treatment of articular manifestations refractory to conventional therapy in Systemic Lupus Erythematosus patients

The primary objective of this study is to evaluate the efficacy of Anakinra in patients with SLE and articular manifestations refractory to conventional treatment.

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).

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 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

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.

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

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.

Randomized Trial of Radiation Therapy With or Without Chemotherapy for Endometrial Cancer

This randomized phase III trial is studying chemotherapy and radiation therapy to see how well they work compared with radiation therapy alone in treating patients with high-risk, stage I, stage II, or stage III endometrial cancer.

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

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X)

The primary objective of this study is to evaluate the safety and tolerability of LY2127399 (120 mg every 4 weeks [Q4W] + SoC or 120 mg every 2 weeks [Q2W] + SoC) in patients with SLE who have completed 52 weeks of treatment in either Study BCDS or Study BCDT. Safety and tolerability assessments for Study BCDX include the following: - Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) - Laboratory evaluations (including chemistry, immunoglobulins, hematology, B cell counts, and urinalysis) - Immunogenicity (anti-LY2127399 antibodies)

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.

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.

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.

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

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 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 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 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.

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

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.

Multicenter, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, Tolerability, and Immunogenicity of a Single, Subcutaneous Dose of 100μg/kg XM22 in 21 Children with Ewing Family of Tumors or Rhabdomyosarcoma

The primary objective of the study is to assess the pharmacokinetics (PK) of a single subcutaneous (SC) injection of XM22, 100 μg/kg body weight (BW), in children with Ewing family of tumors or rhabdomyosarcoma.

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 randomized, double-blind, placebo controlled trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of lixisenatide in paediatric (10 - 17 years old) and adult patients with type 2 diabetes

To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric population (10-17 years old) and adults as controls

Effects of a Walking Program and Inspiratory Muscle Training on Individuals With Chronic Heart Failure

Patients with chronic heart failure need a "safe and effective" exercise program that will improve their quality of life. For this study, we will determine if adult chronic heart failure patents assigned to an experimental exercise group of walking and Inspiratory Muscle Training (IMT) program will have an additional effect on respiratory muscle strength (PImax), cardiovascular endurance, quality of life, walking speed, heart rate variability, and physical activity level compared to subjects who are assigned to the home walking and "sham" Inspiratory Muscle Training (IMT) program.

Study of the Safety and Efficacy of LY2623091 in Chronic Kidney Disease Patients

To investigate the effect of LY2623091 on change from baseline in proteinuria after 3 weeks of daily oral dosing in CKD patients.

Linsitinib in Treating Patients With Gastrointestinal Stromal Tumors

This phase II trial studies how well linsitinib works in treating younger and adult patients with gastrointestinal stromal tumors.

Reproducibility of Plasma Nucleosomes and Free DNA as Markers for Venous Thromboembolism

The main objective of this study is to evaluate, for 15 healthy volunteers and for 15 patients with a history of venous thromboembolism (VTE), the monthly variation (over 6 months) of plasma nucleosome and free DNA concentrations.

Randomized double-blind placebo controlled Phase II study to evaluate the efficacy and safety of Sorafenib treatment in patients with advanced (recurrent, persistent and/or metastasizing) medullary thyroid carcinoma (SUMMIT).

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

Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma

In previous studies, the investigators found that in patients with Hodgkin's lymphoma (HL) treated with ABVD (adriamycin, bleomycin, vinblastine and decarbazine) the absence of alopecia may predict for a poor response to treatment [complete remission (CR) rate 79% versus 31%, P < 0.0005, respectively]. Also, patients without alopecia had fewer episodes of either leucopenia, neutropenia, deferral of treatment courses or number of courses with dose reduction [88% vs. 62.5%, P=0.05, for the presence of at least one of them]. One of the explanations for this phenomenon is related to a lower systemic exposure of chemotherapeutic drugs in patients who retain their hair. There is a wide interpatient variability in the pharmacokinetic and pharmacodynamic parameters of doxorubicin systemic exposure and the degree of myelosuppression. In a pilot study on 18 patients the investigators could not find the previous association between alopecia, response to chemotherapy and bone marrow depression. However, when analyzing doxorubicin pharmacokinetics, patients who had no remission had 2 fold lower AUC (area under the curve) and 3 fold lower peaks (p=0.06). The investigators' lack to approve the previous findings might be explained by the small study group.

A randomized, phase II, multicenter, double-blind, placebo-controlled study evaluating the efficacy and safety of metmab in combination with either bevacizumab + platinum + paclitaxel or pemetrexed + platinum as first-line treatment in patients with stage IIIb or IV Non-Squamous Non−Small Cell Lung Cancer (NSCLC)

To evaluate the efficacy of MetMAb compared with placebo by PFS in all patients and in the subgroup of patients with Met diagnostic–positive tumors in each of two combination treatment cohorts: Cohort 1: MetMAb + bevacizumab + platinum + paclitaxel vs. placebo + bevacizumab + platinum + paclitaxel Cohort 2: MetMAb + platinum + pemetrexed vs. placebo + platinum + pemetrexed

A Prospective, Randomized, Double-Blind, Parallel-Group Study to Compare the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Subjects with Essential Hypertension

To assess the therapeutic equivalence of eprosartan (a new formulation containing only the active moiety eprosartan) with eprosartan mesylate (currently marketed formulation) on sitting diastolic blood pressure (DBP) in ambulatory subjects with mild to moderate essential hypertension after 8 weeks of treatment (monotherapy).

Perindopril Amlodipine for the Treatment of Hypertension (PATH)

The purpose of the study is to evaluate the safety and efficacy of a fixed-dose combination drug compared to two other drugs (monotherapies) in controlling hypertension

A Phase I/II Trial of Crolibulin (EPC2407) Plus Cisplatin in Adults With Solid Tumors With a Focus on Anaplastic Thyroid Cancer (ATC)

The primary objective in the Phase I portion is to assess the safety and tolerability of cisplatin and crolibulin given in a 21-day cycle in dose-seeking cohorts.

Vandetanib to Treat Children and Adolescents With Medullary Thyroid Cancer

To study the activity of Vandetanib in children and adolescents with MEN-related MTC by measuring the change in tumor size, in blood levels of proteins produced the tumor (calcitonin and CEA) and in tumor-related diarrhea. To determine the safety and tolerability of Vandetanib in children and adolescents. To study how the body handles Vandetanib in children and adolescents. To determine the effect of Vandetanib on the survival of children and adolescents with MTC.

Multi-centre Study to Assess the Efficacy and Safety of AZD5423 in COPD Patients on a Background Therapy of Formoterol

The purpose of the study is to assess the efficacy and safety of two staggered dose levels of inhaled once daily AZD5423 or twice daily budesonide for 12 weeks in COPD patients on a background therapy of formoterol.

Multicenter, Open-Label Study of Telaprevir in Combination With Peginterferon Alfa and Ribavirin in Human Immunodeficiency Virus/Genotype 1 Chronic Hepatitis C Coinfected Subjects With Severe Fibrosis or Compensated Cirrhosis

The objective of this open-label safety study is to collect safety and tolerability data on telaprevir treatment in combination with Peg-IFNalfa and RBV in subjects with HIV/genotype 1 chronic HCV coinfection with severe fibrosis or compensated cirrhosis who are not eligible for enrollment into an ongoing clinical study of telaprevir.

A Randomized Phase 2 Placebo-Controlled Study of LY2495655 in Patients with Advanced or Metastatic Pancreatic Cancer Receiving Chemotherapy

To determine if LY2495655 administered in combination with chemotherapy improves overall survival (OS), compared to chemotherapy in combination with placebo in patients with Stage II-IV unresectable pancreatic cancer

Chemotherapy Followed By Surgery Vs Radiotherapy Plus Chemotherapy in Patients With Stage IB or II Cervical Cancer

Randomized phase III trial to compare the effectiveness of chemotherapy followed by radical hysterectomy with that of chemotherapy plus radiation therapy in treating patients who have stage IB or stage II cervical cancer.

A Long-Term Follow-Up Study of Subjects Who Participated in a Clinical Trial in which BMS-914143 was Administered for the Treatment of Chronic Hepatitis C

To determine the durability of virologic response in subjects treated in a previous study with Lambda (BMS-91413) with or without ribavirin (RBV) and/or Direct Acting Antivirals (DAA), who have HCV RNA less than the limit of quantitation of the assay (< LOQ) at the completion of the required post-treatment follow-up in the previous (parent) study.

To determine the feasibility of using Microbubble technology to detect sentinel nodes in vulvar cancer.

To determine the feasibility of using Microbubble technology to detect sentinel nodes in vulvar cancer 1. Identification of one or more inguinofemoral lymph nodes 2. Correct intraoperative identification of the sentinel node as verified by Technetium 99m & patent blue dye

TOPARP: Phase II Trial of Olaparib in Patients with Advanced Castration Resistant Prostate Cancer.

The primary objective of this study is to evaluate the activity of olaparib in patients with advanced prostate cancer who have progressed following one or two chemotherapy regimens including docetaxel.

A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination with Carboplatin and Etoposide (PaCE) Chemotherapy versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients with Extensive-Stage Small Cell Lung Cancer.

The primary objective of this study is to compare the efficacy of palifosfamide-tris in combination with carboplatin and etoposide (PaCE) chemotherapy to carboplatin and etoposide (CE) alone, as measured by overall survival (OS), in chemotherapy naïve subjects with extensive-stage SCLC.

Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d) (Protocol JNJ-27018966IBS3001)

The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of JNJ-27018966 compared with placebo in the treatment of patients with diarrhea-predominant irritable bowel syndrome.

Effects of morning vs evening dosing on the pharmacokinetics and pharmacodynamics of sunitinib.

To determine the influence of morning versus evening administration on the pharmacokinetics of sunitinib and its metabolite

A randomized, phase II, multicenter, double-blind, placebo-controlled study evaluating the efficacy and safety of metmab in combination with paclitaxel + cisplatin or carboplatin as first-line treatment for patients with stage IIIb (T4 disease) or IV squamous non-small cell lung cancer (NSCLC)

To evaluate the duration of progression-free survival of MetMAb + paclitaxel + platinum (cisplatin or carboplatin) relative to placebo + paclitaxel + platinum in all enrolled patients and in the subgroup of patients with Met diagnostic–positive tumors

A phase II Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as treatment re-challenge in Patients, who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non- Small Cell Lung Cancer (NSCLC) and who previously responded to gefitinib and received subsequent chemotherapy or other active anti-cancer therapy excluding EGFR-TKIs

To characterise the impact of gefitinib on the Response Evaluation Criteria in Solid Tumours (RECIST) based assessments; objective response rate (ORR ; confirmed complete response(CR) or partial response (PR)) and disease control rate (DCR; confirmed complete response(CR) or partial response (PR) or stable disease (SD)) in patients with EGFR M+ NSCLC

Effects of morning vs evening dosing on the pharmacokinetics and pharmacodynamics of sunitinib.

To determine the influence of morning versus evening administration on the pharmacokinetics of sunitinib and its metabolite

Effects of oral administration of ivabradine (7.5 mg bid) on post-ischaemic stunning induced by exercise stress in patients with coronary artery disease and exercise inducible ischaemia.

To assess the effects of Ivabradine on post-ischaemic stunning induced by exercise stress in patients with stable coronary artery disease and exercise-inducible ischaemia

Randomized Phase II Study of Cabazitaxel versus Topotecan in Small Cell Lung Cancer Patients with Progressive Disease during or after a First Line Platinum Based Chemotherapy

To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in patients with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy.

Study to evaluate the pharmacokinetic of vitamin D (cholecalciferol) in patients with obesity after bariatric surgery in vitamin D deficiency and after normalization

Establish vitamin D supplementation in obese patients after bariatric surgery.

Phase II study on ET-743 in BRCA1 and BRCA2 mutation carrie and BRCAness phenotype advanced ovarian cancer patients.

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.

Monitoring Chronic Obstructive Pulmonary Disease Patients at Home by a Forced Oscillation Technique Device

The purpose of this study is to measure daily variability of FOT data measured at home of a group of COPD patients in order to identify possible correlations between symptoms change, breathing pattern, lung mechanical impedance and occurrence of exacerbation.

An Open Label Phase II Study on the Use of Panobinostat in Combination with Bortezomib and Dexamethasone as Induction in Multiple Myeloma Patients Candidate to High-Dose Therapy

To evaluate if the combination of Panobinostat, Bortezomib and high-dose Dexamethasone as induction therapy can increase the complete response (CR) rate in subjects with previously untreated multiple myeloma who are candidates to autologous stem cell transplantation (ASCT).

CD2 Lozenges in Preventing Acute Oral Mucositis in Patients With Head and Neck Cancer Receiving Radiotherapy and Chemotherapy

This phase III trial studies how well Lactobacillus bevis CD2 lozenge prevents oral mucositis in patients with head and neck cancer who are being treated with cisplatin and radiation therapy. These results will be compared to results in patients using placebo lozenges.

A Phase 1/2 Study of Lenalidomide in combination with Bendamustine (LEBEN) in relapsed and primary refractory Hodgkin Lymphoma

To determine the best tolerated and effective dose (dose finding) for oral Lenalidomide among 10, 15, 20 e 25 mg dose levels in a 28-day cycle, as associated to a fixed dose of weekly bendamustine (60 mg/m2 on days 1, 8 and 15), based on the best trade-off between toxicity and efficacy according to the Bayesian phase I/II dose finding method of Thall and Cook in subjects with Recurrent Hodgkin Lymphoma

An open-label phase IIIb study of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy

The main objectives of this study are (I) to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed all approved standard therapies and (II) to assess the safety of regorafenib

A 24 week randomised, open label, 3 parallel-group comparison of once and twice daily biphasic insulin aspart (BIAsp) 30 plus sitagliptin and twice daily BIAsp 30, all in combination with metformin in insulin naïve type 2 diabetic subjects inadequately controlled on sitagliptin and metformin

To compare the efficacy in terms of glycaemic control of biphasic insulin aspart 30 (BIAsp 30) twice daily + sitagliptin + metformin, BIAsp 30 twice daily + metformin and BIAsp 30 once daily + sitagliptin + metformin in subjects with type 2 diabetes inadequately controlled on sitagliptin and metformin (± other oral anti-diabetic drugs (OADs))

Prospective study of 18F-RGD PET-CT in assessment of response to antiangiogenic treatment in patients with renal cancer and comparison with perfusion CT

To evaluate whether changes of uptake on 18F-RGD PET-CT before, during and after anti-angiogenic therapy are associated with tumour response in patients with cancer.

Magnetic resonance with gadoxetic acid for the diagnosis of hepatocellular carcinoma in patients with liver cirrhosis. Evaluation of its impact for the non-invasive diagnosis.

To establish the diagnostic accuracy of magnetic resonance imaging with gadoxetate disodium for the diagnosis of hepatocellular carcinoma that do not fulfil the established diagnostic criteria as per current guidelines of AASLD (American Association for the Study of Liver Diseases)

Phase 2a Single-Arm Safety Study of Elotuzumab in Combination with Thalidomide and Dexamethasone in Subjects with Relapsed and/or Refractory Multiple Myeloma

To determine the safety and tolerability of Thalidomide-dexamethasone-Elotuzumab (TdE) in subjects with relapsed and/or refractory MM as assessed by the incidence of severe (Grade 3 or higher) non-hematologic adverse events (AEs).

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

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

A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Study of LY2228820, a p38MAPK Inhibitor, plus Gemcitabine and Carboplatin versus Gemcitabine and Carboplatin for Women with Platinum-Sensitive Ovarian Cancer

Phase 1b - to determine the recommended Phase 2 dose of LY2228820 that can be safely administered with gemcitabine and carboplatin Phase 2 - to compare the progression-free survival in patients treated with LY2228820 plus gemcitabine and carboplatin versus placebo plus gemcitabine and carboplatin

Prospective pharmacodynamic study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets.

To evaluate the effect of Rifaximin-EIR, administered at a daily dosage of 1,600 mg (2 x 400 mg tablet twice a day) for three months in patients with a moderately active Crohn's disease in terms of clinical response and correlation with endoscopic improvement to Rifaximin-EIR treatment.

Chemotherapy or Observation in Stage I-II Intermediate or High Risk Endometrial Cancer

This study evaluates if one can improve survival in intermediate and high risk early-stage patients by offering them postoperative chemotherapy. This is a randomized phase 3 trial where effect of postoperative chemotherapy is compared with postoperative observation alone (standard strategy).

Dynamic Contrast Enhanced Computed Tomography (CT) for Head and Neck Cancer

For patients undergoing treatment for head and neck cancer, this study will use dynamic contrast-enhanced CT scans to try to determine which lymph nodes in the neck contain cancer and require surgical removal.

DABIRENAL STUDY A study to investigate the pharmacokinetics and effects of Dabigatran in patients with stable severe chronic kidney disease

To analyze the pharmacokinetics and dynamics of Dabigatran 75 mg twice daily in patients with severe CKD (eGFR 15 - 30 ml/min) until steady state of the drug is established.

Studies of the effects of a one week course of either azithromycin or metronidazole on plasma concentration of procalcitonin in patients with heart failure and elevated plasma procalcitonin concentrations

In patients with heart failure who have an elevated concentration of procalcitonin (a marker of infection) which is not explained by clinical evidence of infection, can treatment for one week with azithromycin or with metronidazole reduce plasma concentrations of procalcitonin compared to a control group who receive no antibiotics. Procalcitonin is associated with a poor prognosis so understanding the mechanism for an elevated concentration in those without infection may provide a therapeutic target.

Medico-economic Evaluation Comparing the Use of Ultrasonic Scissors to the Conventional Techniques of Haemostasis in Thyroid Surgery by Cervicotomy (FOThyr)

The aim of our study is to evaluate the ultrasonic scissors (Harmonic Focus Ethicon Endo-Surgery Laboratory) as a device of hemostasis in thyroid surgery (total thyroidectomy) by cervicotomy, and to show a decrease in transient hypoparathyroidism compared to conventional techniques of haemostasis (clips, ligatures, and bipolar coagulation). Secondary objectives of the study are the evaluation of (i) recurrent nerve morbidity, (ii) postoperative bleeding, (iii) postoperative pain, (iv) cost of both techniques (microcosting), (v) the overall cost of the techniques at six months, (vi) a linking of costs and medical outcomes and (vii) an estimation of the potential impact of new technology on the organization of operating rooms (operating time).

A randomized double blind placebo controlled study on the effects of fenretinide Lym-X-Sorb on insulin sensitivity in obese insulin resistant subjects

To assess the effects of fenretinide on hepatic and peripheral insulin sensitivity in obese, insulin resistant subjects

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less.

To determine the effect of chemotherapy in breast cancer patients with lymph node that do not have the Recurrence Score (RS) high by Oncotype DX® test.

A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination with Doxorubicin vs. Doxorubicin Alone in Subjects with Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

1. To evaluate the efficacy of TH-302 in combination with doxorubicin as determined by overall survival in subjects with locally advanced unresectable or metastatic soft tissue sarcoma previously untreated with chemotherapy (neoadjuvant and adjuvant chemotherpapy permitted) compared with doxorubicin alone 2. To assess the safety of TH-302 in combination with doxorubicin in subjects with locally advanced unresectable or metastatic soft tissue sarcoma compared with doxorubicin alone

A multicenter, randomized, double-blind, placebo-controlled Phase IIb Efficacy Study of Vx-001, a peptide-based cancer vaccine aimed to maintain disease control after first line treatment in HLA-A*0201 positive patients with TERT positive NSCLC (stage IV or recurrent stage I-III)

The primary objective is to compare survival rate at 12 months in Vx-001 treated vs placebo treated patients.

Efficacy and safety of liraglutide versus placebo as add-on to existing diabetes medication in subjects with type 2 diabetes and moderate renal impairment

To confirm the superiority of liraglutide versus placebo as add-on to existing oral antidiabetic drug (OAD) and/or insulin therapy on glycaemic control after 26 weeks treatment in subjects with type 2 diabetes and moderate renal impairment

An Open-label, Multicenter Phase 1/2 Study of JNJ-40346527, a FMS Inhibitor, in Subjects with Relapsed or Refractory Hodgkin’s Lymphoma

Phase 1: To establish the recommended Phase 2 dose for JNJ-40346527. Phase 2: To determine the overall response rate (complete response [CR] + partial response [PR]) in subjects with relapsed or refractory cHL.

Renal Denervation in Patients With Advanced Heart Failure

Sympathetic system has important role occurrence of symptoms in heart failure. Renal denervation that is ablated some of sympathetic nerves is affected pathology of heart failure. This interventional therapy improves symptoms and life quality.

A Study of JNJ-40346527 in Patients With Relapsed or Refractory Hodgkin Lymphoma

The purpose of this study is to determine the safety, pharmacokinetics, and preliminary efficacy information of JNJ-40346527 in patients with relapsed or refractory Hodgkin lymphoma.

Study of Hepatitis C Virus (HCV) Entry Inhibitor in Liver Transplant Recipients With HCV Infection

This study will test the safety and tolerability of HCV Entry Inhibitor ITX 5061 in Liver Transplant Recipients with Hepatitis C infection. The investigators hypothesize that ITX 5061 oral monotherapy will be safe in adults during and after liver transplantation and that therapy will also inhibit HCV infection of newly transplanted livers in adults with prior HCV infection.

Effect of oral administration of red clover on menopausal symptoms of the syndrome induced by adjuvant hormonal treatment in women diagnosed with breast cancer

Decrease of menapausal symptoms in women treated with tamoxifen for breast cancer after surgery

Phase II, open-label clinical trial to evaluate the safety and efficacy of platelet-rich plasma and fibrin clot processed with PRGF-System tecnology in the treatment of anal fistulas in Crohn's patients

To evaluate the safety and feasibility of intralesional platelet-rich plasma and fibrin clot from autologous origin, processed with PRGF-System tecnology (BTI), for the treatment of perianal fistulas in Crohn's disease.

A Phase III, randomized, double-blind trial to evaluate the efficacy, safety and tolerability of TMC435 vs. telaprevir, both in combination with PegIFNα-2a and ribavirin, in chronic hepatitis C genotype-1 infected subjects who were null or partial responders to prior PegIFNα and ribavirin therapy.

To demonstrate the non-inferiority of TMC435 versus TVR, both given in combination with PegIFNα-2a and RBV, by less than 12%, with respect to the proportion of subjects with SVR 12 weeks after the planned end of treatment (SVR12).

A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared with Telaprevir in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis-C + Pharmacogenetics Blood Sample Amendment 01 (version 1.0 dated 23-Nov-11)

To compare rates of SVR12, defined as HCV RNA < LOQ (detectable or undetectable) at follow-up Week 12, for genotype 1 patients treated with either BMS-790052 or TVR in combination with pegIFNα-2a/RBV

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

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

Small and Large Bowel Transit Tests Using MRI (Study 1)

Evidence shows that anxiety plays a part in IBS and can speed up transit time in the small bowel. In this study, the investigators hypothesise that since anxiety is a common feature of IBS, then fast small bowel transit is likely to be found in all subtypes of IBS and the difference in stool frequency and consistency in IBS subgroups are therefore likely to reflect differences in colonic function. The investigator wish to test this by measuring both small and large bowel transit times using Magnetic Resonance Imaging (MRI) and validate the results of the MRI with two methods currently used in clinical practice -The previously validated lactose-C13 Ureide breath test (for small bowel transit) and the standard radio-opaque pellet method to assess the whole gut transit (WGT) time.

Application of High Resolution Diffusion-Weighted MR Imaging Plus Sequence in Head and Neck Cancer

Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. The purpose of this study is to determine if a new MR imaging method can help tumor evaluation in head and neck cancer. The extra images will be obtained using Diffusion-weighted Magnetic Resonance Imaging which provides image contrast through detection of small restrictions in the movement of water molecules. This study may help us provide additional information about the tumor along with the picture of the organ.

A phase IV, multicenter, randomized, double-blind, placebo-controlled study of efficacy and safety of Sorafenib in patients with hepatocellular carcinoma after radiological progression

To determine efficacy of Sorafenib in advanced hepatocellular carcinoma (stage C of BCLC classification) after radiological progression.

Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery

This randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel followed by doxorubicin hydrochloride work compared to observation in treating patients with high-risk uterine leiomyosarcoma previously removed by surgery.

A Multicenter Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer.

To assess the antitumor activity of PM01183 in terms of overall response rate (ORR) according to RECIST vs 1.1 in each cohort of metastatic breast cancer (MBC) patients.

A 16 Week, Open Label, Multi-Centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects with Pulmonary Arterial Hypertension

The primary objective of this study is to evaluate the safety and tolerability of a rapid dose titration regimen of SC (subcutaneous) Remodulin therapy in patients with PAH. Safety and tolerability of the rapid dose titration regimen will be considered to be demonstrated by all clinical trial subjects that complete the 16 week treatment period of the study without experiencing any serious adverse events considered by the investigator to be possibly related to Remodulin.

A double blind, randomized, placebo controlled, crossover study of the effectiveness of oral fampridine in improving upper limb function in progressive multiple sclerosis.

To assess the effect of treatment with fampridine in patients with secondary progressive MS (SPMS) or primary progressive MS (PPMS) with upper limb dysfunction (as defined by a 9-HPT time of between 15-90 seconds) and Kurtzke EDSS scores in the range 4.0-7.0 on 1. Upper limb function assessed by the nine-hole peg test (9-HPT) and the Jebson Taylor Hand Function Test (JTT). 2. Scores of the MSIS-29 (physical), MSWS-12 and the Disabilities of the Arm, Shoulder and Hand Score (DASH)

CANVAS: A Randomized, Double-Blinded, Placebo-Controlled Trial of Cvac (Autologous Dendritic Cells Pulsed with Recombinant Human Fusion Protein [Mucin 1-Glutathione S Transferase] Coupled to Oxidized Polymannose) as Maintenance Treatment in Patients with Epithelial Ovarian Cancer (EOC) in Complete Remission Following First-Line Chemotherapy

To assess the efficacy, in terms of progression-free survival (PFS), of Cvac as compared with placebo for the maintenance treatment of patients with epithelial ovarian cancer (EOC) in complete remission (CR) following first-line chemotherapy

Lean Body Mass as a determinant of docetaxel pharmacokinetics and toxicity (LEANDOC)

To determine which anthropometric parameters Lean body mass, total body mass or body surface area correlates best to docetaxel exposure (AUC) .

Insulin therapy in non-diabetic adults with cystic fibrosis

This study aims to investigate the effect of low dose insulin therapy on nutritional status en body weight.

Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma

This phase I/II trial studies the side effects and best dose of bendamustine hydrochloride when given together with gemcitabine hydrochloride and to see how well it works in treating patients with relapsed or refractory Hodgkin lymphoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy, may kill more cancer cells.

An open label, multiple dose Phase III clinical study in patients with prostate cancer to investigate the clinical efficacy and safety of a new GnRH implant (AMW Leuprorelin 10.72 mg implant) applied twice every 84 days

Overall objective: to investigate the clinical efficacy and safety of the new GnRH implant (AMW Leuprorelin 10.72 mg implant) applied twice in every 84 days. Primary objective: to demonstrate that AMW Leuprorelin 10.72 mg implant leads to a consistent suppression of testosterone levels below castrate level (0.5 ng/mL).

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

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

Entecavir and Peginterferon for Immune-Tolerant Adults With Chronic Hepatitis

To determine whether entecavir and peginterferon can be used to treat people in the immune-tolerant phase of chronic hepatitis B.

A single arm study in metastatic colorectal cancer patients treated with pharmacokinetically (PK) dose adjusted weekly or biweekly 5-fluorouracil (5-FU) regimes.

To determine whether pharmacokinetically-guided dose adjustment of 5-FU provides a stable intrapatient dose level of 20-30 mg.h /l. The primary analysis will be the comparison of the proportion of patients with AUC within 20 to 30 mg.h/L after the first 5-FU application versus the fourth application.

Efficacy of Prophylactic Treatment With Antibiotics During Concomitant Chemoradiotherapy in Patients With Head and Neck Cancer to Prevent Aspiration Pneumonia (PANTAP)

The purpose of the study, is to determine whether prophylactic antibiotics may decrease the development of pneumonia. Prophylactic antibiotics means that there are no signs of pneumonia are already

Compliance: Role Emerges for Success in Chronic Myelogenous Leukaemia (CML): Evaluation aND Optimisation

This study on patient's compliance in clinical workaday life aims to assess and to improve CML treatment in Germany by means of adherence supporting measures and to increase adherence awareness by physicians and patients.

Randomised, Multicenter Phase III Clinical Study of Lipoplatin plus Gemcitabine Versus Gemcitabine as First-Line Treatment in Inoperable, Locally Advanced or Metastatic Pancreatic Cancer

To compare the activity and safety between the two arms of treatment.

A phase II trial of BKM120 (a PI3K inhibitor) in patients with triple negative metastatic breast cancer

To determine clinical activity of BKM120 in patients with metastatic triple negative breast cancer that have developed disease progression after standard chemotherapy in the adjuvant or metastatic setting.

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

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

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. - To correlate a pre-specified five biomarker panel reflective of ErbB3 signaling activity with the clinical outcome of patients (correlation between PFS and other clinical efficacy criteria with biomarker signature)

A 24-week, open-label, randomized, 2-arm parallel group, multinational, multi-center clinical trial to compare the efficacy and safety of lixisenatide injected prior to the main meal of the day versus lixisenatide injected prior to breakfast in type 2 diabetic patients not adequately controlled on metformin

To compare the two treatment regimens in terms of change of HbA1c from baseline to endpoint (week 24)

Effects of bosentan in a HOMogenEous population of SSc subjects with an early or active SSc nailfold capillaroscopic pattern (HOME II)

Evaluate the effect of bosentan on the blood flow in the hands from baseline to 12 weeks, measured by laser Doppler imaging, in SSc subjects with an early or active SSc pattern, measured with nailfold capillaroscopy (NFM), with ongoing digital ulcer disease and a history of DU disease in the past 2 years.

A multicentre, randomised, double-blind, two arm, parallel group, pilot study to assess the effect of Gaviscon Advance as add-on therapy in GORD patients with inadequate response to once daily proton pump inhibitor treatment.

The primary objective of the study is to assess the efficacy of Gaviscon Advance (an aniseed flavoured oral suspension) compared with placebo in the suppression of GORD symptoms in patients whose symptoms are inadequately controlled by once daily PPI therapy alone.

Taste, Smell and Chemotherapy (TASTY)

Taste and smell abnormalities are common in cancer patients undergoing chemotherapy, with a prevalence ranging from 46% to 77% for taste changes, and 35% to 75% for smell changes. These chemosensory changes are distressing for patients and can lead to changes in appetite, food choice, and nutrient intake. These changes can result in malnutrition and weight loss. Possibly, also unhealthy eating patterns can be developed due to these taste and smell changes, given the high prevalence of obesity among survivors of certain cancer types. The primary objective is to investigate the nature, prevalence, and duration of taste and smell changes in patients with disseminated testicular cancer treated with cisplatin based chemotherapy.

A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate plus Lomustine Therapy compared to Lomustine Monotherapy in Patients with Recurrent Glioblastoma

Overall Survival

Assessment of multidrug resistance in breast cancer with [11c]Tariquidar PET

To correlate PET imaging outcome parameters (e.g. volume of distribution (VT) of [11C]tariquidar in tumor tissue) at staging with Pgp expression levels measured by IHC at baseline (diagnostic biopsy)

Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib (PAGIST)

Patients with metastatic or locally advanced gastrointestinal stromal tumors (GIST) who develop resistance against the two hitherto approved drugs for this disease, the tyrosin kinase inhibitors (TKIs) imatinib and sunitinib, have a poor prognosis. Sometimes a further response may be achieved by other drugs, mainly other TKIs, which have been explored in different studies but not yet have been approved for clinical use. Pazopanib is a TKI inhibiting the tyrosin kinases KIT, PDGFRA, and VEGF 1-3, all of which have important roles in the pathogenesis of GIST. Theoretically, it may function in GIST, and it deserves investigational trials. The drug is approved for metastatic renal cancer and is relatively well tolerated. In this trial (SSG XXI), the disease control rate (DCR) = (CR+PR+SD) after 12 weeks of treatment will be assessed as the primary endpoint, and at the same time trough levels will be measured. Secondary endpoints include ORR, PFS, toxicity, and disease control rate in relation to trough level week 12 and in relation to the primary mutation of the tumor (if known). The goal is to include 72 patients in the trial, which is open and single arm.

Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers

This multicenter phase II trial is studying the side effects of weekly paclitaxel/carboplatin when given with prophylactic G-SCF in patients with recurrent epithelial ovarian-, primary peritoneal or fallopian tube cancers, endometrial carcinoma or cervical carcinoma.

a single arm open label international multi center study of the efficacy and safety of sunitinib malate (su011248, sutent®) in patients with progressive advanced metastatic well differentiated unresectable pancreatic neuroendocrine tumors.

To confirm sunitinib treatment effect on progression-free survival (PFS) per investigator assessment in subjects with advanced/metastatic, well differentiated, unresectable, pancreatic neuroendocrine tumors per RECIST.

Optimal Tube Feeding Method in Head and Neck Cancer Patients

The purpose of this study is to assess the optimal tube feeding method (bolus, gravity or pump) by analyzing percent weight loss, tolerance of enteral feeds, and percent of estimated calorie and protein needs in 60 patients with squamous cell carcinoma of the head and neck undergoing chemoradiation therapy.

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 mg and 50 mg Compared with Placebo in Subjects with Type 2 Diabetes

To evaluate the efficacy of TAK-875 compared with placebo on glycemic control as assessed by change from baseline in HbA1c over a 24-week Treatment Period.

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

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

Calcitonin stimulation: pentagastrin vs. calcium gluconate - potency, feasibility and tolerance in chronic kidney disease.

Comparison of the two calcitonin stimulation tests pentagastrin and calcium gluconate regarding potency, feasibility and tolerance.

Pharmacokinetics of Caspofungin (Cancidas ®) Given Intravenously as Therapy to Patients With an Invasive Fungal Infection in the Intensive Care Unit - a Search for Co-variates (CASCADE)

The pharmacokinetics of caspofungin are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine caspofungin concentrations in 20 ICU patients, who will get caspofungin as standard care.

Pseudohyponatremia of Multiple Myeloma is True Hyponatremia

Hypothesis: the hyponatremia of multiple myeloma (m.m.)is true and not pseudohyponatremia by using the stewart approach to acid - base interpretation, would like to show that the positive charged m- proteins produced in m.m.result in true hyponatremia.

Melanoma Margins Excision Trial

Recent data analysis has shown that data are seriously lacking on the safety and efficacy of margins less than 2cm for melanomas >2mm in Breslow thickness, and arguably insufficient for melanomas >1mm in thickness, for loco-regional control of melanoma recurrence. No RCT currently addresses 1 vs 2cm margins for melanomas in the >1mm thickness group. A trial is needed to answer this question.

Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

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

Iron Therapy in Colo-Rectal Neoplasm and Iron Deficiency Anemia: Intravenous Iron Sucrose Versus Oral Ferrous Sulphate.

The main objective of this study is to evaluate the efficacy of intravenous iron sucrose in increasing preoperative haemoglobin values in patients with colo-rectal neoplasm and iron deficiency anemia, compared to the standard treatment with oral iron. It will also determine whether intravenous iron sucrose administration improves outcomes such as postoperative haemoglobin values, serum ferritin values, transfusional needs, postoperative complications, or length of hospital stay.

Remote Monitoring of Chronic Heart Failure in Veneto Region

The purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. In addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.

A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP).

To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of ≥ 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period.

A prospective, randomised multi-centre phase II study evaluating the adjuvant, neoadjuvant or palliative treatment with tamoxifen +/- GnRH analogue versus aromatase inhibitor + GnRH analogue in male breast cancer patients.

To determine the estradiol suppression between the three treatment arms after three months.

A phaseI/II study of Sunitinib in young patients

To characterize the plasma PK profile of sunitinib and its active metabolite SU012662 in children and young adults with advanced (defined as unresectable without major morbidity, metastatic or recurrent) GIST.

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

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

Effect of Pentoxifylline on the Tight Junctions (TJS) of the intestinal mucosa in patients with Irritable Bowel syndrome (IBS).

Determine the therapeutic effectiveness of treatment with oral pentoxifiline in the severity and the clinic evolution of patient with IBS.

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

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

Transhepatic Arterial Chemotherapy (TAC) Versus Transcatheter Arterial Chemoembolization (TACE) Plus Folfox4 as the Treatment of Unresectable Liver Metastasis of Colorectal Cancer

The purpose of this study is to investigate whether TAC plus FOLFOX4 or TACE plus folfox4 are able to improve resection rate and overall survival in patients receiving primary colorectal tumor resection than given FOLFOX4 only.

Early Access Program of Telaprevir With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects

The purpose of this early access program is to provide telaprevir to patients with a specific type of hepatitis C viral infection (termed 'genotype 1') who are expected to benefit from telaprevir-based therapy but who reside in countries in which telaprevir is not yet commercially available and who are not eligible for enrollment into a clinical study of telaprevir. The study also aims to collect information on the safety and adverse events with telaprevir treatment in combination with peginterferon alfa and ribavirin, which is typically used to treat patients with hepatitis C. In addition to hepatitis C viral infection, patients in this study will also have a diagnosis of liver fibrosis and compensated liver disease.

Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient

Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer.

A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma

The primary objective of this study is to determine the preliminary efficacy of administration of INNO-206 compared to doxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcoma as measured by progression-free survival, progression-free survival at 4 and 6 months, tumor response and overall survival.

Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse

Assessment of the antitumour effect of zoledronic acid in patients with multiple myeloma and asymptomatic biochemical relapse. It´s proposed to investigate the use of Zoledronic acid as single therapy in patients with Multiple Myeloma in biochemical relapse.

Study for prevention of peritoneal carcinomatosis in patients with stomach cancer

Reducing the risk of peritoneal carcinosis in patients with stomach cancer with following treatment: gastrectomy incl. HIPEC vs. gastrectomy excl. HIPEC

Study for prevention of peritoneal carcinomatosis in patients with stomach cancer

Reducing the risk of peritoneal carcinosis in patients with stomach cancer with following treatment: gastrectomy incl. HIPEC vs. gastrectomy excl. HIPEC

A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

To assess the progression-free survival of oral veliparib in combination with temozolomide or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and metastatic breast cancer.

A Phase I/II Study of Cabazitaxel Combined with Abiraterone Acetate and Prednisone in Patients with Metastatic Castrate-Resistant Prostate Cancer (CRPC) whose Disease has Progressed after Docetaxel Chemotherapy

To determine the maximum tolerated dose, and dose limiting toxicities of cabazitaxel administered as a 1-hour infusion every 3 weeks in combination with oral daily abiraterone acetate and prednisone in patients with metastatic CRPC To estimate the anti-tumor activity of cabazitaxel in combination with abiraterone acetate and prednisone in terms of PSA response rate

Phase II trial of palliative Epirubicin, Oxaliplatin & Capecitabine (EOX) Chemotherapy combined with omega-3 fish oil infusion (omegaven) in patients with oesophago-gastric carcinoma

To see whether adding intravenous ω-3 FA emulsion to standard palliative chemotherapy (EOX) improves quality of life and/or prognosis, in patients with incurable gastric or oesophageal carcinoma.

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

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

Adding liraglutide to the backbone therapy of biguanide in patients with coronary artery disease and newly diagnosed type-2 diabetes

The main objective of the trial is to investigate whether glucagon-like peptide-1 (GLP-1) analogue combined with metformin therapy compared to metformin monotherapy a) improves betacell function b) improves left ventricular ejection fraction (LVEF) during stress test in newly diagnosed type-2 diabetes mellitus (T2D) patients, who exhibit stable coronary artery disease (CAD)

Narrow-band Imaging, Autofluorescence Imaging and Gastroesophageal Reflux Disease

Aim of this study is to compare the efficacy of narrow band imaging (NBI) and autofluorescence imaging (AFI) to distinguish subtle mucosal change related to acid reflux that is not visible in standard white light imaging (WLI) endoscopy, and help indicating the diagnosis of gastroesophageal reflux disease (GERD).

Masitinib in Gastro-intestinal Stromal Tumor (GIST) Resistant to Imatinib

The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to imatinib.

A Multicenter, Randomized, Double-Blind Placebo-Controlled, Phase 2b Study to Compare the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2, Ribavirin) to Triple Therapy (with VX-222-Placebo) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis

To compare the antiviral efficacy of a quadruple drug regimen (VX-222, telaprevir, pegylated interferon [Peg-IFN], and ribavirin [RBV]) to a triple drug regimen (placebo, telaprevir, Peg-IFN, and RBV) in subjects with genotype 1 chronic hepatitis C (CHC) with compensated cirrhosis, who are treatment naive or were nonresponders or relapsers to previous Peg-IFN/RBV therapy.

Phase II Study for the Evaluation of the Efficacy of Gemcitabine plus Erlotinib in Rash-positive Patients with metastatic pancreatic cancer and good risk factors

1-year survival rate of "good risk" patients who develop Rash under treatment with gemcitabine/erlotinib

Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma

This trial seeks to determine if WBRT reduces the spread of brain metastases and lengthens the time to recurrence. The trial also examines the effect of WBRT on quality of life and brain functions such as memory, speech and concentration.

Potentially resectable metastatic colorectal cancer with wild-type KRAS and BRAF: alternating chemotherapy plus cetuximab - A randomised phase II trial - Nordic 7.6

Response rate (RR) estimate by the investigator

Potentially resectable metastatic colorectal cancer with wild-type KRAS and BRAF: alternating chemotherapy plus cetuximab - A randomised phase II trial - Nordic 8

The purpose of this study is to assess the response rate

A Study of [F-18]HX4 (PET Imaging)Evaluated in Head and Neck Cancer Patients

The purpose of this trial is to determine what will be the optimal imaging protocol for Head and Neck Cancer patients after [F-18] HX4 injection. This study will provide guidance for future studies involving [F-18]HX4 in cancer patients.

A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease

To induce clinical response (CDAI decrease from baseline ≥ 100 points) and/or remission (CDAI <150) following 12 weeks of treatment with one of two active doses of GSK1605786A for qualification of subjects for enrolment into a follow-on 52-week maintenance study (CCX114157).

A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's Disease Revised Protocol 01 incorporating Protocol Amendment 02; Pharmacogenetics Blood Sample Amendment 01

The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn’s Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn’s Disease

Superficial vein thrombosis (SVT) treated for forty-five days with Rivaroxaban versus Fondaparinux

Evaluation of efficacy and safety of 45 days of rivaroxaban 10 mg vs. fondaparinux 2.5 mg in the treatment of superficial vein thrombosis of risk patients for major VTE complications to prove non-inferiority of oral rivaroxaban treatment

Role of PET/CT with 18F-choline in biochemical relapse in prostate cancer patients treated with radical intent. Pet Col study.

To assess the sensitivity of Pet Ct

Perioperative FOLFOXIRI and bevacizumab compared with postoperative FOLFOX in patients with resectable liver metastases from colorectal cancer (PERIMAX).

The primary objective of this study is to evaluate the efficacy of 5-Fluorouracil (5-FU) and oxaliplatin (FOLFOX-Regimen) for 6 months postoperatively compared to 5-FU, oxaliplatin and irinotecan (FOLFOXIRI-Regimen) with bevacizumab for three months pre- and three months postoperatively for resectable liver metastases from colorectal cancer.

Population Pharmacokinetics in Benznidazol-treated adults with Chronic Chagas Disease. Benznidazol Pharmacokinetics and adverse reactions relationship.

To study population pharmacokinetics in Benznidazol-treated adult patients with Chronic Chagas Disease to get information to optimaze drug doses.

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

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

Surgery With or Without Radiation Therapy in Treating Patients With Previously Untreated Nonmetastatic Retroperitoneal Soft Tissue Sarcoma

This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma.

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

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Ranolazine on Major Adverse Cardiovascular Events in Subjects with a History of Chronic Angina Who Undergo Percutaneous Coronary Intervention with Incomplete Revascularization

The primary objective of this study is to evaluate the efficacy of ranolazine as compared with placebo when used as part of standard medical therapy in chronic angina subjects with incomplete revascularization post-PCI on the composite of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization.

A Randomized, Open Label, Multicenter, Phase II, 2-Arm Study comparing the conventional 3 weekly schedule of Jevtana (Cabazitaxel) with a weekly regimen in patients with Metastastic Castration Resistant Prostate Cancer ConWeCab

To determine if a weekly regime improves tolerability of cabazitaxel compared to the standard 3 week regimen

Lowering viral load with nucleos(t)ide analogues prior to peginterferon alfa-2b treatment to increase sustained response in HBeAg-positive chronic hepatitis B (PEGON-STUDY)

To investigate sustained HBeAg response to peg-interferon alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide analogues, thereby lowering viral load

A Phase 1b/2 Randomized Study of MEDI-575 in Combination With Carboplatin Plus Paclitaxel Versus Carboplatin Plus Paclitaxel Alone in Adult Subjects With Previously Untreated, Advanced Non-Small Cell Lung Cancer

Evaluation of progression-free survival of subjects following treatment with MEDI-575 when used in combination with paclitaxel/carboplatin versus paclitaxel/carboplatin alone in subjects with previously untreated, advanced non-small cell lung cancer

A prospective, multicenter, open-label, patients with non-erosive gastroesophageal reflux disease (NERD) non-responders to therapy with PPIs

The prospective evaluation of the prevalence data - based on proper compliance, timing, type and dose of PPI - of NERD patients with typical symptoms (vs. atypical and extra-esophageal) resistant or poorly responsive to treatment with esomeprazole 40mg for 8 weeks / day

Adaptive Radiation Treatment for Head and Neck Cancer (ARTFORCE)

This Phase II trial aims to explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN.

Correlation Between RECIST-conventional Imaging Techniques, Morphologic Response by CT- Histopathologic Response in Hepatic Metastasis Secondary to Colorectal Cancer

The purpose of this study is to to evaluate the correlation of overall objective response according to RECIST v1.1. criteria evaluated by conventional imaging techniques, morphologic response by CT, and histopathologic response in patients with resectable hepatic metastasis secondary to colorectal cancer treated with bevacizumab in combination with XELOX.

Biological, Pathological and Imagery Markers in the First-Line Treatment of Metastatic Clear-Cell Renal Cell Carcinoma

The aim of this study is to identify and/or validate biomarkers and imaging markers to predict and monitor the activity of a new class of therapeutic agents called antiangiogenics for the treatment of metastatic renal cell carcinoma (mRCC). Suntinib, approved for this indication, will be administred before and after nephrectomy and biomarkers sampling and imaging will be operated to monitor the activity and identify prognostic factors in mRCC.

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

All patients are treated according to the same therapy regimen. Therapy duration (number of cycles) and radiotherapy vary according to age group, stage and response. Chemotherapy consists of a pre-phase-treatment (for all patients) and varying A, B and C cycles. Therapy for Patients in the 18-55 Age Group Patients in stages III-IV and all patients with mediastinal tumors or extranodal involvement are administered 6 cycles (A1, B1, A2, B2, A3, B3). Chemotherapy is stopped after 4 cycles (A1, B1, A2, B2) for patients with stage I/ II if a clear CR has been achieved and there is initially no mediastinal or extranodal involvement. In cases of refractory or progressive disease after 4 cycles, study therapy is stopped. These patients are to be given salvage therapy with subsequent stem cell transplantation. Therapy for Patients older than 55 years The course corresponds to that of patients in the younger age group, but the regimen is dose reduced (A1*, B1*,A2*, B2*, A3*, B3*). Antibody therapy with anti-CD20 is to be administered on day 1 of each chemotherapy cycle (A, B). After end of chemotherapy (6 or 4 cycles) 2 more cycles of anti-CD 20 are to be administered to reach a total number of 8 resp. 6 cycles antibody therapy.

Prophylactic Use of Entecavir for Non-Hodgkin's Lymphoma Patients With Resolved Hepatitis B

Hepatitis B (HBV) reactivation and hepatitis flare induced by cytotoxic chemotherapy is common in cancer patients who have chronic HBV infection. Lymphoma patients who had previous infected by HBV but negative for HBsAg have a the risk of HBV reactivation during chemotherapy, but prophylactic antiviral treatment is not a routine by current American Association for the Study of Liver Diseases (AASLD) guideline. Prophylactic entecavir might reduce the risk of HBV reactivation in such patients.

HD-R3i - A prospective, randomized, placebo-controlled, international, multicenter phase I/II trial of RAD001 (everolimus) in combination with DHAP as induction therapy in patients with relapsed or refractory Hodgkin Lymphoma

The main objectives of this study are to identify the RPTD (recommended phase II dose) of RAD001 in combination with DHAP (Ever-DHAP) and to demonstrate the efficacy of Ever-DHAP as induction therapy

Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery

Recent findings have suggested that laparoscopic surgery is safe and effective, as well as laparotomic one, for treating patients with early stage endometrial cancer (ESEC). Moreover, our long-term previous data have shown a trend in vaginal cuff recurrence in subjects who underwent laparoscopic approach to ESEC consisting of extrafascial hysterectomy, bilateral salpingo-oophorectomy, pelvic +/- para-aortic nodes dissections, regardless grading or lymphovascular space invasion. Based on these considerations, the aim of the current protocol-study will be to compare two different strategies for vaginal cuff recurrences prevention in patients affected by ESEC treated with laparoscopic surgery. In particular, upper vaginectomy followed by observation will be compared to post-operative brachytherapy.

Trial Between Two Follow up Regimens With Different Test Intensity in Endometrial Cancer Treated Patients

This study aims to compare two different follow up regimens with different test intensity in endometrial cancer treated patients.

Letrozole as a Treatment of Endometrial Cancer

The purpose of this study is to determine if the investigators can predict which patients might benefit from Letrozole treatment by studying the many different forms of the estrogen receptor molecule that exist within the cancer tissues.

Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma

The purpose of this multicenter study is to examine whether the proposed randomized treatment regime results in a significantly longer survival time and higher quality of life than any additionally applied multiple chemotherapy according to the CVD- scheme. So far neither established treatment regimes nor reliable data exist for the second-line chemotherapy of metastatic malignant melanoma. Patients are therefore mostly treated with single or multiple chemotherapeutics or/and immunomodulatory therapeutics. These regimes however imply often not only a higher toxicity but show rarely a response rate higher than 10%.

Characterization of the Melanoma-Specific Immune Response

The aim of this study is to study T-cells. Blood will be collected and the samples will be used to generate T cell clones. Two separate blood draws will be required at the maximum.

Neurotropic Melanoma of the Head and Neck

This is a 2-armed randomised controlled trial comparing surgery alone with surgery plus post-operative radiation therapy for patients with completely resected primary melanoma showing histological features of neurotropism. Uncontrolled studies suggest that this form of primary melanoma has a high risk of local recurrence and that postoperative radiation therapy may substantially reduce that risk. Patients who are eligible on the basis of the pathology of the excised melanoma will be offered the opportunity to take part in the trial. Those randomised to receive radiation therapy will be treated with a simple technique encompassing the surgical bed plus a margin. Radiation will commence within 3 months of surgery

Cisplatin, Etoposide, and Two Different Schedules of Radiation Therapy in Treating Patients With Limited Stage Small Cell Lung Cancer

This randomized phase III trial is studying two different schedules of radiation therapy to compare how well they work when given together with cisplatin and etoposide in treating patients with limited stage small cell lung cancer.

A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage

Comparison of two combination chemotherapies in the treatment of patients with SLCL

Phase I-II Trial of Sorafenib in Combination With Ifosfamide in Soft Tissue Sarcoma

A recent trial, however, reported an unexpected incidence of cardiac toxicity in patients with STS treated with Bevacizumab, a monoclonal antibody that binds VEGF, in combination with Doxorubicin. This finding suggest that the possibility of potentiation of the cardiotoxicity of Doxorubicin when inhibiting the VEGF pathway cannot be ruled out. The association of Sorafenib with Ifosfamide, the other established active agent against STS, could improve the efficacy of single-agent Ifosfamide minimizing the risk of cardiac toxicity .

Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma

The purpose of this study is to find out whether treatment with a new drug, sunitinib, can increase the effectiveness of radiotherapy at killing cancer cells; to test the safety of the combination of sunitinib and radiotherapy.

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

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

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

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

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

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

Correlation Between SV2A Expression in Tumour Tissue and Efficacy of Levetiracetam in Glioma Patients With Epilepsy

The purpose of this study is to investigate the correlation of SV2A expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with their clinical response to levetiracetam.

National Screening in Denmark With MR Versus Mammography and Ultrasound of Women With BRCA1 or BRCA2 Mutations

The purpose of the study is to determine whether MR of the breast is a better screening tool than mammography combined with ultrasound of the breast in women with BRCA1 or BRCA2 gene mutations.

STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing Pilot)

This is a randomized study comparing the use of Anastrozole before and continuing during radiotherapy for breast cancer compared to the use of anastrozole after irradiation.

Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

The purpose of this study is to determine whether the prophylactic ipsilateral central lymph node dissection is equally effective in the management of papillary thyroid microcarcinoma(PTMC) to the bilateral central lymph node dissection.

Laparoscopic Approach to Cervical Cancer

The goal of this clinical research study is to compare the long-term outcomes of different surgical methods for the treatment of cervical cancer. The long-term outcome of a total abdominal radical hysterectomy (TARH) will be compared against laparoscopy. In this study, the laparoscopy will be done with or without robotic technology.

Neoadjuvant Chemotherapy Followed by Surgery Versus Concurrent Chemoradiation in Carcinoma of the Cervix

Carcinoma cervix is a common malignancy in women in developing countries including India. The standard treatment of locally advanced cervical cancer (Stages IB2 to IIIB)is concomitant chemoradiation (CT RT) using platinum based chemotherapy. Some studies, including a meta-analysis conducted by the Cochrane group, have indicated that few courses of neoadjuvant chemotherapy (NACT) followed by surgery may be superior to radical radiation alone for these patients. However NACT-Surgery approach has never been compared to the current standard of concomitant CT RT. The present study is undertaken to compare, in a randomized trial, NACT(3 courses of paclitaxel-carboplatin) followed by surgery to concomitant CT RT in stages IB2 to IIB squamous cell carcinoma of the uterine cervix.

Concomitant Chemoradiation in Advanced Stage Carcinoma Cervix

A study to evaluate the efficacy of concomitant chemoradiation as compared to radiotherapy alone. Concomitant chemoradiation is not a new treatment modality for carcinoma cervix. Studies have shown improvement in survivals with chemoradiation, but majority of the patients was in early stages. Since this treatment modality has not been tested adequately in advanced stages in our setting, the present study is being undertaken. The study arm of chemoradiation has the potential to improve the survivals by 10%, but is associated with additional 5% risk of toxicities, which are treatable. In the study arm, apart form the standard radiotherapy treatment, you will receive weekly chemotherapy injections (Cisplatin) during external radiation therapy. The study arm is associated with additional 5% acute hematological and gastrointestinal toxicities, which are treatable with medications, blood transfusions, modifications in the ongoing treatment etc.

Tasigna in Glivec-resistant or Intolerant Patients in CML

The purpose of this study is to evaluate efficacy and safety of nilotinib in patients with Imatinib resistant or intolerant CML-CP or AC. Efficacy evaluation will be made by Complete cytogenetic response rate(CCyR) at 12 months after nilotinib administration.

Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia

The investigators seek to compare two techniques of removing pre-cancerous lesions from the colon. The investigators also will compare two solutions used during the procedure to determine if either solution allows for an improved removal of the tumors.

Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer

The purpose of this study is to investigate whether preoperative TAC is able to improve progression free survival and overall survival in patients receiving liver metastasis resection of colorectal cancer.

Preoperative Assessment of Colon Tumor

The purpose of this study is to determine whether a colonic tumor can be classified as malignant or benign with magnetic resonance (MR) colonography. Patients with a verified colon carcinoma or benign tumor based on diverticulitis are offered a MR colonography with intravenous (I.V.) contrast. The tumor is classified as malignant or benign by assessing the dynamic contrast uptake and morphology. The Investigator is blinded from the verified diagnosis and the MR classification is compared to the histological diagnosis.

Study to Evaluate the Efficacy of Pravastatin on Survival and Recurrence of Advanced Gastroesophageal Cancer

The survival of esophageal cancer and stomach cancer (EGC) at 5 years is less than 30%. Pravastatin is a potent inhibitor of HMG-CoA reductase inhibitor that has shown increased survival in patients with advanced hepatocellular carcinoma. The objective is to evaluate the efficacy of treatment (increase in survival and recurrence-free period of the disease) with pravastatin in patients with advanced EGC.

Influence of N-Acetylcysteine on Morbidity, Oxygenation and Cytokine Levels in Partial or Total Esophagectomy for Cancer

The purpose of this study is to evaluate the effect of high-dose n-acetylcysteine on inflammatory reaction, pulmonary morbidity, oxygenation and quality of life in patients undergoing transthoracic, partial or total resection of the esophagus for cancer.

Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment Trial

The purpose of this study is to compare the results of preoperative chemotherapy and radiation followed by surgery to surgery followed by postoperative chemotherapy and radiation for esophageal cancer.

A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma

This multicentered clinical trial is going to find out the radio-sensitization action of sodium glycididazole in radiochemotherapy for esophageal cancer.

Endovascular renal sympathetic denervation versus spironolactone for treatment-resistant hypertension: a randomized, multicentric study

To compare the effect of renal sympathetic denervation with the spironolactone in treatment-resistant hypertension on blood pressure

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

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

An Open-Label, Phase 3 Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Coinfected With Genotype 1 Hepatitis C Virus and Human Immunodeficiency Virus Type 1(HCV/HIV-1)

To assess the hepatitis C antiviral efficacy of telaprevir, peginterferon alfa-2a, and ribavirin

A Phase 2, Randomized Study of Bortezomib/dexamethasone With or Without Elotuzumab in Subjects with Relapsed/Refractory Multiple Myeloma.

To compare Progression Free Survival between treatment arms in the overall population.

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

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

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

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

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

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

A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination with mFOLFOX6 with Bevacizumab in Combination with mFOLFOX6 in Stage IV Metastatic Corectal Cancer (mCRC) Subjects

To compare progression-free survival (PFS) between tivozanib in combination with mFOLFOX6 with bevacizumab in combination with mFOLFOX6 based on investigator radiological tumor assessment.

An 8-week randomized, open label, multi-center study to study to evaluate the efficacy and safety of oral aliskiren 300 mg once daily under light meal versus fasted condition in patients with hypertension

To evaluate the efficacy of oral aliskiren 300 mg given once daily in reduction of mean 24 hour ambulatory systolic blood pressure (maSBP) from baseline to end of 8 week treatment under light meal (fed) versus fasted conditions in patients with mild to moderate hypertension.

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

To evaluate the analgesic efficacy of pregabalin in pancreatic cancer induced abdominal pain

A phase IIa study to characterize the effects of CCL2 inhibition with the Spiegelmer® NOX-E36 in patients with type 2 diabetes mellitus and albuminuria.

To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio (ACR) in patients with type 2 diabetes and albuminuria

An open-label, single arm, multi-centre, Phase II study to evaluate the safety and efficacy of PC-A11 with superficial and interstitial laser light application in patients with recurrent head and neck squamous cell carcinoma unsuitable for surgery and radiotherapy and without distant metastases

To assess the efficacy of PC-A11 with superficial and/or interstitial laser light application in patients with recurrent SCCHN without distant metastases by means of non-progression rate at 6 months

A Randomised, Double Blind, Placebo Controlled, Multi-centre, Parallel Group, Interventional Study of Mesalazine (Asacol®) Treatment in IBS and the Evaluation of Rectal Inflammatory Status using the Mucosal Patch Technique

To assess the effect of mesalazine (Asacol®) treatment compared to placebo on IBS symptoms.

A Randomized, 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 PFS per enhanced 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 Randomised Controlled Double-Blind Trial of Intranasal Fentanyl versus Intravenous Morphine in the Emergency Department Treatment of Severe Painful Sickle Cell Crises in Children

The primary objective of this study is to illustrate the comparative efficacy of intranasal fentanyl to IV morphine in reducing severe pain associated with Painful Sickle Cell Crises in the Emergency Department.

A randomised phase II trial of [18F]fluorothymidine and the standard tracer [18F]Fluorodeoxyglucose in the assessment of systemic therapy response in triple negative breast cancer and their utility compared to conventional MRI imaging response, early ADC change and biopsy derived biomarkers

Part A: To confirm repeatability of Positron Emission Tomography (PET) scan SUV measurement before chemotherapy in triple negative breast cancer using [18F]FLT and [18F]FDG tracers Parts A and B: To evaluate PET imaging using each of the two randomly allocated PET tracers ([18F]FLT and [18F]FDG) as a method for evaluating response to systemic therapy in primary triple negative breast cancer at an earlier timepoint than is possible with standard imaging using MRI scans

Diagnostic accuracy of MRI, diffusion-weighted MRI, FDG-PET/CT and Fluoro-ethyl-choline PET/CT in the detection of lymph node metastases in surgically staged endometrial and cervical carcinoma

This study will evaluate three new imaging techniques that may be used to identify malignant nodes preoperatively: (1) Diffusion Weighted MRI, (2) FDG-PET/CT and (3) FEC-PET/CT. The principal objective is to compare the diagnostic performance of each test (detection and false-positive rates) with that of the standard method (size criteria) with histology as the reference standard.

A Phase II, Single Arm, Investigative Study of IMM-101 in Combination with Radiation Induced Tumour Necrosis in Patients with Previously Treated Colorectal Cancer

To investigate the efficacy of IMM-101 in combination with radiation induced tumour necrosis (induced by CyberKnife treatment) in patients with colorectal cancer with metastatic disease who have received prior chemotherapy.

An open-label, randomized phase III trial of cisplatin and 5-fluorouracil with or without panitumumab for patients with nonresectable, advanced or metastatic esophageal squamous cell cancer

To demonstrate superiority of 5-fluorouracil, cisplatin and panitumumab over 5-fluorouracil and cisplatin alone in terms of overall survival in esophageal cancer

Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus

Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and normalizes serum ALT in chronic hepatitis B patients (CHB) with few adverse effects. Two aspects on tenofovir use in pregnancy will be evaluated prospectively in this study: - the data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA > 6log10 copies/mL during late pregnancy and infants - Its efficacy in the reduction of HBV vertical transmission rate

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

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

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

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

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

A phase III multicentre trial of weekly induction chemotherapy followed by standard chemoradiation versus standard chemoradiation alone in patients with locally advanced cervical cancer

In women with locally advanced cervical cancer, does the addition of weekly chemotherapy prior to chemoradiation alone improve overall survival compared with chemoradiation alone?

A randomised phase 2 study of paclitaxel with or without GSK1120212 in advanced wt BRAF melanoma

Phase 1 - To establish the maximum tolerated dose of GSK1120212 in combination with paclitaxel in the treatment of patients with advanced melanoma. Phase 2 - To compare the efficacy of GSK1120212 in combination with paclitaxel, compared with paclitaxel alone in the treatment of patients with advanced or metastatic melanoma.

LUX-Lung 7: A randomised, open-label Phase IIb Trial of afatinib versus gefitinib as first-line treatment of patients with EGFR mutation positive advanced adenocarcinoma of the lung

To compare the progression-free survival (PFS) and disease control rate (at 12 months) of afatinib with gefitinib among patients with adenocarcinoma of the lung harbouring activating EGFR mutations who have no prior systemic chemotherapy in advanced setting (stage IIIB or IV)

A phase III, randomized, active controlled, assessorblinded study of safety and efficacy of Pegylated Apofilgrastim versus US and EU licensed Neulasta® in subjects with stage IIa, IIb or IIIa breast cancer receiving TAC anticancer chemotherapy in adjuvant setting

To demonstrate an equivalent efficacy of Pegylated Apo‐Filgrastim as compared to each of the commercially available US and EU licensed Neulasta® in patients suffering from early breast cancer and receiving TAC (docetaxel, doxorubicin, cyclophosphamide) anticancer chemotherapy in adjuvant setting.

A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer

To ascertain whether the survival of patients randomized to Arm V+G (PROSTVAC plus GM-CSF) or to Arm V (PROSTVAC) is superior to that from patients randomized to Arm P (placebo control).

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

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

Randomised phase II window study of short-term preoperative treatment with the PI3K inhibitor GDC-0941 plus Anastrozole versus Anastrozole alone in patients with ER-positive primary breast cancer

In women with ER-positive breast cancer about to undergo surgery, does two week's pretreatment with a new drug (the PI3K inhibitor GDC-0941, given in combination with the estrogen-blocker anastrozole) increase the benefits of anastrozole in slowing down tumour cell growth, as measured by laboratory measurements on tumour cells?

The effects of neoadjuvant hormonal therapy on the course of PSA and testosterone in patients with low and intermediate-risk prostate carcinoma (NEO-ONE); A randomized controlled trial

To assess the effects of 3-month NHT with Eligard 22.5 mg once and Bicalutamide 50 mg daily on the course of PSA in patients treated with BT for low-intermediate risk localized prostate carcinoma

A phase I/II, randomized, open-label, multi-centre study of BIBF1120 + reirradiation (R-RT) versus reirradiation in the treatment of patients with first or second progression of glioblastoma

Phase I - Maximal tolerated dose of BIBF1120 in combination reirradiation - Safety and tolerability of BIBF1120 in conjunction with radiotherapy - Pharmacokinetic studies in plasma and cerebrospinal fluid Phase II Primary objective: - 6 months rate of progression-free survival (PFS6)

Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis

There is a need to evaluate the current diagnostic and treatment practices in Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) in Central and Eastern European Countries, with special focus on the use of conventional disease modifying antirheumatic drugs (DMARDs) and biologic agents. Further, it is necessary to establish the long-term clinical outcomes of adalimumab therapy in routine clinical practice, in particular its sustained effectiveness, impact on extra-articular manifestations (EAMs), co-medication with Nonsteroidal anti-inflammatory drugs (NSAIDs) and work productivity.

Non invasive imaging of [18F]HX4 with Positron-Emission-Tomography (PET) in Head and Neck Cancer.

Determine if tumor hypoxia can be accurately visualised with [18F]HX4 PET imaging in head and neck cancer tumors

Gulf Acute Heart Failure Registry (GulfCARE)

The Gulf Heart Association (GHA) sponsored Gulf acute heart failure registry (Gulf CARE)is a multinational , multicentre, prospective, observational, hospital-based registry of patients with acute heart failure(AHF) with 3 month and one year follow-up. Study Hypothesis: Due to variations in age at presentation, risk factors for heart failure particularly high prevalence of rheumatic heart disease in certain Gulf countries, variable medical practices and heart failure management setup in the Gulf region, AHF patients in the Gulf states are expected to have different presentation and receive different management than patients in European countries resulting in different outcome. It is also hypothesized that there is considerable gap between heart failure management guidelines and clinical practices in the Gulf region.

A Multi-center, Randomized, Open-label study for Induction of HBsAg decline using an add-on treatment of peginterferon alfa-2a in HBeAg-negative chronic hepatitis B patients treated with nucleos(t)ide analogues

To investigate whether addition of PEG-IFN alfa-2a in HBeAg-negative chronic hepatitis B patients who are pretreated with NA enhances the degree of HBsAg decline.

Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin's Lymphoma

The objective of this study is to see if yttrium-90 daclizumab, high-dose chemotherapy, and stem cell transplants can treat HL that has not responded to earlier treatments.

Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure (IDENTIFY-HF)

The purpose of this study is to characterize the feasibility and impact of a diagnostic tool that may help clinicians identify when patients are at higher risk of visiting the hospital for a heart failure event. The study will use a non-experimental device that is inserted just under the skin of the chest, which continuously monitors the heart rhythm in combination with an experimental web-based heart failure risk status. Patients with atrial fibrillation and heart failure with preserved ejection fraction (ejection fraction > 40%) will be evaluated to collect data about the potential of this risk status to help improve patient outcome.

A multi-center, open label, uncontrolled, Phase IIa clinical trial evaluating the safety and efficacy of NOX-A12 in combination with a background therapy of bortezomib and dexamethasone (VD) in previously treated patients with multiple myeloma (MM)

To assess the safety and tolerability of NOX-A12 alone (pilot group only) and in combination with VD To determine the overall response rate according to IMWG uniform response criteria (ORR = best response at least partial response(PR))

Phase II pilot, prospective, open label, multicenter Clinical Trial, to evaluate the safety and efficacy of PF299804, a pan-HER irreversible inhibitor, in patients with recurrent glioblastoma with EGFR amplification or presence of EGFRvIII mutation

To assess progression-free survival (PFS) at six months (PFS6m) in patients with recurrent glioblastoma with EGFR amplification or presence of EGFRvIII mutation.

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 of memantine in the treatment of fibromyalgia: an open, uncontrolled, exploratory 3-months follow-up study

Evaluate the efficacy of memantine in the reduction of glutamate brain levels in patients with fibromialgia

A Phase 3 Evaluation of BMS-790052 in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Subjects with Chronic Hepatitis C Genotype 4 + Pharmacogenetics Blood Sample Amendment 01 (version 1.0 dated 12-Aug-11)

To compare rates of SVR12 for Genotype 4 subjects treated with either BMS-790052 or placebo in combination with pegIFNα-2a/RBV.

A randomized, double-blind, parallel-group, multi-center Phase III study comparing the efficacy and safety of EP2006 and Neupogen® in breast cancer patients treated with myelosuppressive chemotherapy

To assess the efficacy of EP2006 compared to Neupogen® (US-licensed) with respect to the mean duration of severe neutropenia (DSN), defined as the number of consecutive days with Grade 4 neutropenia (absolute neutrophil count [ANC] less than 0.5 x 10 9/L), during Cycle 1 of the neoadjuvant or adjuvant TAC regimen (Taxotere® [docetaxel 75 mg/m2] in combination with Adriamycin® [doxorubicin 50 mg/m2] and Cytoxan® [cyclophosphamide 500 mg/m2]) in breast cancer patients.

A Randomised, Double-blind Controlled Phase 4 Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose with Placebo in Patients with Chronic Heart Failure and Iron Deficiency

To determine, relative to placebo, the effect of iron repletion therapy using intrravenous (IV) FCM on exercise capacity assessed by 6-minute walk test (6MWT) at 24 weeks after initiation of therapy in subjects with CHF and ID

A randomised, placebo controlled trial to study the effect of heme-arginate on heme-oxygenase-1 induction and renal function in recipients of deceased donor renal transplants.

Does treating the recipients of deceased donor kidneys with heme-arginate (HA) increase the amount of HO-1 protein in the recipient’s white blood cells compared to placebo treatment?

Everolimus in Refractory Testicular Germ Cell Cancer

Everolimus in refractory testicular germ cell cancer. Everolimus 10 mg /day/ is administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements. Feasibility of surgical resection will be assessed after every 2 cycles of the treatment in patients with partial response.

Phase II Study of Weekly Cabazitaxel for Advanced Prostate Cancer in "Unfit" Hormone-Refractory Patients Previously Treated with Docetaxel.

Evaluate the activity of the weekly administration of cabazitaxel as time to PSA progression according to the PCCTWG II criteria.

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

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

Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT

The purpose of this study is to characterize tumour uptake of somatostatin analog 68Ga-DOTATOC in patients with either primary or recurrent malignant glioma. The investigators hypothesis is that some primary and recurrent malignant gliomas overexpress SST2 receptor which can be imaged with 68Ga-DOTATOC PET/CT. The investigators also hypothesize that tumor uptake of 68Ga-DOTATOC correlates with immunohistochemically determined SST2 receptor status of the tumor specimen.

An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with Multiple Sclerosis

The primary objective of the study is to assess the effect of long-term treatment with prolonged-release fampridine 10 mg twice daily on the physical component scale (PCS) of the Short Form (36) Health Status Questionnaire (SF-36) as reported by treatment responders.

DOVIGIST: Phase II trial to evaluate the efficacy and safety of Dovitinib (TKI258) in patients with gastrointestinal stromal tumors refractory and/or intolerant to imatinib

To assess the antitumor activity of Dovitinib (TKI258) in terms of disease control rate (DCR): CR+PR+SD, at 12 weeks in adult patients with documented disease progression while on therapy with imatinib for unresectable and/or metastatic GIST, recurrent GIST on adjuvant imatinib or within the first 3 months after discontinuation of adjuvant imatinib or, unresectable and/or metastatic GIST intolerant to imatinib

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

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

A phase I/IIa study of the safety, tolerability and biological effect of single and repeat administration of the selectively replication-competent herpes simplex virus HSV1716 into the tumour-bearing pleural cavity (intrapleural) in patients with inoperable malignant pleural mesothelioma.

The principal research objective is to investigate whether HSV1716 is safe and well-tolerated when administered directly into the cavity that surrounds and protects the lungs (pleural cavity) of patients with a type of cancer that originates from the linings of the pleural cavity (malignant pleural mesothelioma). The study will assess this question in the context of three groups of patients. One group will receive a single dose of HSV1716, the second group will receive two doses and the third group will receive four doses.

A Phase II Trial of Panobinostat and Lenalidomide in Patients With Relapsed or Refractory Hodgkin's Lymphoma

This phase II trial studies how well giving panobinostat together with lenalidomide works in treating patients with relapsed or refractory Hodgkin lymphoma.

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

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

Short Course vs. Standard Course Radiotherapy in Elderly and/or Frail Patients With Glioblastoma Multiforme

This is a multi-centre prospective, non-inferiority trial. Patients will be randomized to two treatment groups in a 1:1 ratio and will be stratified by age, Karnofsky Performance Status and extent of the surgical resection. This study will assess the effect of a one-week radiotherapy regimen in comparison with a three-week radiotherapy regimen on the survival of elderly and/or frail patients with glioblastoma multiforme (Frail: ≥>50 years old and with a KPS of 50% or less50%-70%; Elderly and frail: ≥65 years and with a KPS of 50% - 70%; Elderly: ≥65 years and with a KPS of 80% - 100%).

An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)

To assess the efficacy of I10E in increasing platelet count and controlling bleedings in patients suffering from primary Immune ThrombocytoPenia (ITP).

A feasibility study of Multimodal Exercise/Nutrition/Anti-inflammatory treatment for Cachexia – the pre-MENAC study

Is a multimodal intervention for cancer cacheixa feasible? Specific indiviudal treatments such as exercise, nutritional advice, dietary supplements and anti-inflammatory medications have been shown to be beneficial in isolation in the treatment of cancer cachexia. It is hypothesized that combining all of these as a "multimodal intervention" may be beneficial. Before a definitive study is conducted to assess this, it is important that the feasibility of delivering such an intervention is assessed - which is the purpose of the proposed study. The feasibility will be assessed by: Enrolment rate, Compliance with study intervention, study procedures and data collection, Contamination-rate in the control group with respect to any of the interventions in the intervention group, and Provide an estimate of the sample size required in futures studies in cachexia.

Exocrine Pancreatic Function Testing in Cystic Fibrosis

The purpose of this study is to develop and validate multimodal testing of exocrine pancreatic function. The investigators will be testing exocrine pancreatic function in patients with cystic fibrosis. Exocrine pancreatic function and imaging will be correlated to age group, genotype, nutritional status and quality of life. Earlier detection of exocrine pancreatic failure in the non classical form of CF may be of therapeutically benefit.

Assessing Decision Maker Tools for Asthma: the Asthma APGAR

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

Reduce IDentified UNcontrolled Asthma (RIDUNA)

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

AZD2281 Plus Carboplatin to Treat Breast and Ovarian Cancer

To determine the optimum doses of AZD2281 and carboplatin that can safely be used in patients with breast and ovarian cancer. To evaluate the response of the tumor to the drug combination and determine the side effects of the treatment.

More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery

The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time. When the investigators remove the tumor from your brain, it is important that they remove all of the tumor and not remove parts of normal brain. Sometimes this can be difficult because the tumor can look like normal brain. In some brain tumors, 5-ALA can make the tumors glow red under blue light.

Safety and Efficacy Study of Romiplostim to Treat ITP in Pediatric Subjects

The purpose of this study is to evaluate the efficacy of romiplostim in the treatment of thrombocytopenia in pediatric subjects with Immune Thrombocytopenia Purpura (ITP) as measured by durable platelet response.

Cytoreduction with or without intraoperative intraperitoneal hyperthermic chemotherapy (HIPEC) in patients with peritoneal carcinomatosis from ovarian cancer , fallopian tube or primary peritoneal carcinoma : randomized clinical trial.

Investigate whether the administration of HIPEC with Cisplatin (75 miligrams per square meter of body surface) after surgical cytoreduction in women with ovarian , tubal or primary peritoneal carcinoma increased disease-free survival period compared with patients without HIPEC treatment.

Tapentadol PR vs Oxycodon CR A pilotstudiy for a mechanism-orientated Therapy of peripheral chronic neuropathic pain syndrom

It shall be answered if Tapentadol PR compared to Oxycodon CR leads to a normalization of abnormal QST-Parameters (MPT, MPS, DMA and/or WUR with a Z-Value > 1,5 and/or a pathological side difference for these Parameters)

An open-label study to evaluate biomarkers and safety in systemic sclerosis patients treated with ABR-215757 (paquinimod)

To study changes in disease related biomarkers in patients with progressive SSc during treatment with ABR-215757

Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer

The purpose of this study is to help us learn how to lower the risk of a blood transfusion during surgery to remove ovarian cancer. Acute normovolemic hemodilution (ANH) is a technique performed in the operating room before the procedure begins that may reduce the risk of needing a transfusion during ovarian cancer surgery.

Home Delivery of Pemetrexed as Maintenance Treatment in Patients Who Have Not Progressed after Induction Therapy for Advanced Nonsquamous Nonsmall Cell Lung Cancer: A Feasibility Study

To assess the adherence rate to pemetrexed administered in a domiciliary setting.

Rubber Band Ligation and Mucosectomy for Gastroesophageal Reflux Disease (GERD)

The purpose of this study is to determine the safety and effectiveness of two separate procedures to treat gastroesophageal reflux disease (GERD) also known as heartburn. The two therapies are: 1) a banding procedure alone using the Cook® 6 Shooter™ Saeed Multi-Band Ligator or 2) a banding/shaving procedure called Endoscopic Mucosal Resection (EMR) using the Cook® Duette™ Multi-Band Mucosectomy device.

Evaluation of the efficacy, tolerability, and safety of 7 days of treatment with GRT6010 or pregabalin in comparison to placebo in subjects with peripheral neuropathic pain.

To explore the efficacy of GRT010 oral solution on spontaneous and evoked pain in subjects with persistent moderate to severe peripheral neuropathic pain due to post-herpetic neuralgia, post-operative neuropathic pain, or post-traumatic nerve injury

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).

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, and to characterize plasma eltrombopag pharmacokinetics (steady-state plasma eltrombopag Cmax, tmax, AUC(0-?), 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 the study are to evaluate the long-term durability of clinical benefit and the long-term safety and tolerability of eltrombopag in subjects with MDS and AML.

An open-label, single-arm, multi-center phase II study to evaluate the efficacy and safety of AUY922 in combination with trastuzumab standard therapy as second-line treatment in patients with HER2-positive advanced gastric cancer

To assess the preliminary efficacy of AUY922 in combination with trastuzumab standard therapy, using Objective Response Rate (ORR), as per investigator, in advanced HER2+ gastric cancer patients progressing on 1st line trastuzumab containing treatment

FES-PET to Determine ER-expression in Epithelial Ovarian Cancer

In this study the investigators will evaluate whether FES-PET can be used to visualize and quantify ER-expression in ovarian cancer. If these results are positive, this would warrant further exploration of FES-PET imaging in ovarian cancer.

Pazopanib in advanced gastrointestinal stromal tumors refractory to imatinib and sunitinib . A non-comparative phase II multicenter study by the Scandinavian Sarcoma Group

Calculate the disease control rate (DCR)=complete remission (CR)+partial remission (PR) + stable disease (SD) at 12 weeks

Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia

Approximately 84 subjects 18 years of age and over who meet all the eligibility requirements will be randomized. Splenectomized subjects must make up at least 35% of the study population. No single platelet count should be greater than 35x109/L. Subjects will be centrally stratified at randomization by splenectomy status, baseline platelet count, and use of concomitant Idiopathic Thrombocytopenia Purpura (ITP) medication at baseline and will be randomized to receive either double-blind E5501 or placebo in a 2:1 ratio. Subjects will receive blinded therapy at a starting dose of 20mg E5501 or placebo once daily. Subjects will be allowed to have their dose titrated up (maximum dose 40mg E5501 or matching placebo) or down (minimum dose 5mg for E5501 or matching placebo) depending on their response to study drug. The goal of dose modification is to maintain the platelet count at levels greater than or equal to 50x109/L and less than or equal to 150x109/L, and to decrease the need for ITP-directed concomitant medications. The study will consist of three phases: prerandomization, Randomization (Core Study) and the extension study. The duration of treatment in the Core study is 26 weeks and the extension study is up to 2 years.

Phase II trial of individualized selection of chemotherapy in patients with advanced pancreatic carcinoma based on the identification of therapeutic targets in tumor tissue

Determination of the percentage of alive patients after 12 months since the beginning of the trial, in patients with advanced pancreatic carcinoma individually selected and grouped according to tumor tissue expression of therapeutic targets / Determinación de la proporción de pacientes vivos tras 12 meses del inicio del ensayo en enfermos con carcinoma de páncreas avanzado seleccionados de forma individualizada y agrupados en función de la expresión en tejido tumoral de Dianas Terapéuticas.

Phase II trial of individualized selection of chemotherapy in patients with advanced pancreatic carcinoma based on the identification of therapeutic targets in tumor tissue

Determination of the percentage of alive patients after 12 months since the beginning of the trial, in patients with advanced pancreatic carcinoma individually selected and grouped according to tumor tissue expression of therapeutic targets.

Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer death worldwide and in the United States. The majority of lung cancers are non-small cell lung cancer (NSCLC). The majority of NSCLC cases are advanced at the time of diagnosis. Chemotherapy has improved overall survival but remains limited at < 12 months median overall survival. New approaches are needed for second line chemotherapy treatment. Cabazitaxel-XRP6258 has shown increased overall survival in metastatic prostate cancer and it is hopeful it can do the same in advanced NSCLC.

Q-Trial in Patients With Hepatitis C

The goal of this study is to translate laboratory findings that Quercetin, a bioflavonoid, is safe and has antiviral activity in people with hepatitis C.

Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects with Chronic Hepatitis C Genotype 1 (Phase 1b)

To determine weight based doses of boceprevir for children 3 to 17 years of age.

A randomized, double-blind study of capecitabine plus tesetaxel versus capecitabine plus placebo as second-line therapy in subjects with gastric cancer

To evaluate the efficacy and safety of capecitabine plus tesetaxel (capecitabine-tesetaxel) versus capecitabine plus placebo (capecitabine-placebo) as second-line therapy in subjects with gastric cancer

First Line Pazopanib in Poor Risk Patients with Metastatic Renal Cell Carcinoma

Primary analysis will focus on the rate of poor risk patients as defined by the MSKCC criteria who are free of disease progression at 6 months after start of first line treatment with pazopanib.

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Oral E7080 in Addition to Best Supportive Care (BSC) versus BSC Alone in Patients with Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Who Have Failed at Least Two Systemic Anticancer Regimens

Compare the overall survival (OS) of patients receiving E7080 + BSC with those receiving placebo + best supportive care (BSC)

Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery (DARINA)

The primary objective of this study is to compare the clinical safety with long term use of the oral once daily unmonitored thrombin inhibitors dabigatran and rivaroxaban versus subcutaneous administered nadroparin by observing the incidence of major bleeding and clinical relevant non-major bleeding in patients after knee arthroplasty surgery.

Cyp3A4 metabolism before and after surgery induced weight loss in morbidly obese patients, using midazolam as a model drug

To compare midazolam pharmacokinetics in morbidly obese patients before/during a gastric bypass and 0.5-2 year after surgery.

A randomized, open-label, multicenter Phase IIIb study comparing two trastuzumab dosing regimens, each in combination with cisplatin/ capecitabine chemotherapy, as first-line therapy in patients with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

To compare the duration of overall survival in patients who are randomized at enrollment to treatment with one of two trastuzumab dosing regimens (loading dose of 8mg/kg) followed by either 6mg/kg or 10mg/kg maintenance doses given every 3 weeks, plus cisplatin and capecitabine.

Prospective, explorative trial for the detection of circulating cell-free tumor DNA in the plasma of patients with gastrointestinal stromal tumors (GIST) harboring activating mutations of CKIT or PDGFRA pre/post surgery or pre/under treatment with a tyrosine kinase inhibitor or progressive disease irrespective of current or planned treatment. An open-label, non-randomized, multicenter phase IIIb clinical trial.

Goal of the study is to investigate whether tumor-specific CKIT or PDGFRA DNA fragments can be detected and quantified in the plasma of patients with active GIST as defined as GIST lesions that can be measured by diagnostic imaging.

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

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

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

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

Effects of beta-blockers on exercise performance in uncomplicated hypertension

Evaluation of peak VO2, maximal exercise capacity and tollerance in hypertensive patients with 2 treatments versus vasodilator drugs of routine treatment (ACE inhibitors, sartans, Calcium-antagonists, doxazosina).

Chloroquine for Malaria in Pregnancy

The purpose of this study is to test prevention strategies for pregnancy-related malaria. Researchers will compare different malaria treatments and treatment schedules which include chloroquine therapy (weekly doses versus being dosed twice during pregnancy for 3 days each time) to the standard practice of preventive treatment intervals in pregnancy (with the drug sulfadoxine-pyrimethamine given twice during pregnancy).

Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment

The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of fondaparinux injection in patients with venous thromboembolism (VTE).

A Phase 1/2 Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT-464 in Chemotherapy-Naïve Patients with Castration-Refractory Prostate Cancer

The primary objective of the study is to determine the safety and tolerability of orally-administered VT-464 in chemotherapy-naïve patients with castration-refractory prostate cancer (CRPC).

A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE)

To assess the relative efficacy of AZD4547 compared with paclitaxel by comparison of the change in tumour size at 8 weeks in all randomised patients and also in the patients with tumours that have FGFR2 amplification (FISH score 6) alone.

A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE)

To assess the relative efficacy of AZD4547 compared with paclitaxel by comparison of the change in tumour size at 8 weeks in all randomised patients and also in the patients with tumours that have FGFR2 amplification (FISH score 6) alone.

A Phase 2, Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel-Group Study, with an Open-Label Extension to Evaluate the Efficacy, Safety, and Pharmacokinetics of E5501 in Subjects with Chronic Hepatitis C Virus Related Thrombocytopenia who are Potential Candidates for Antiviral Treatment

To evaluate the efficacy of E5501 by measuring platelet response in subjects with chronic hepatitis C virus (HCV)-related thrombocytopenia who require antiviral treatment

A phase IIIb parallel group, open label study of pegylated interferon alfa-2a monotherapy (PEG-IFN, Ro 25-8310) compared to untreated control in children with HBeAg positive chronic hepatitis B.

To compare HBeAg seroconversion (loss of HBeAg and presence of anti-HBe) between a group treated with PEG-IFN monotherapy and an untreated control group.

A Phase 1b/2 Study with Gemcitabine and LY2157299 for Patients with Metastatic Cancer (Phase 1b) and Advanced or Metastatic Unresectable Pancreatic Cancer (Phase 2)

Phase 1b: To determine a safe/tolerable Phase 2 dose of LY2157299 for combination with gemcitabine in patients with solid malignancy, who failed previous approved therapies and/or are amenable to gemcitabine therapy (eg, pancreatic cancer, biliary tract, sarcoma). Phase 2: To compare overall survival (OS) in patients with Stage II-IV unresectable pancreatic cancer when treated with the combination of LY2157299 and gemcitabine with that of gemcitabine plus placebo.

Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor (Monitor-GCSF)

This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for febrile neutropenia (FN) who are receiving filgrastim biosimilar for primary or secondary FN prophylaxis to better describe the patient population at risk for FN, to describe prophylaxis patterns involving filgrastim biosimilar, and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy and surgery, and mortality.

STOMP: Small cell lung cancer Trial of Olaparib (AZD2281) as Maintenance Programme: a randomised, double blind, multicentre phase II trial

To compare the time it takes for the patient's cancer to get worse (tumour gets bigger) when treated with olaparib, as opposed to those patients that receive placebo.

A 12-week clinical double-blind, randomised study of cholecalciferol versus placebo in patients with chronic kidney disease stage 3-4 (CHICK).

To investigate whether there is a difference in the mean change from baseline of the blood levels of parathyroid hormone (PTH) between patients receiving cholecalciferol compared with patients receiving cholecalciferol placebo after 12 weeks’ treatment.

PARAGON: Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological neoplasms

The principal objective of the study is clinical benefit rate determined by the proportion of patients experiencing either stable disease or response within 3 months of commencing treatment.

Study Determining the Safety and Tolerability of Combination Therapy With Pazopanib and GSK1120212 in Advanced Solid Tumors Enriched With Patients With Advanced Differentiated Thyroid Cancer

The purpose of this study is to determine the safety and toxicity of the combination of pazopanib and GSK1120212 in patients with solid tumors and advanced thyroid cancer and identify the maximum tolerated dose (MTD) of this combination for phase II study.

6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both plus Mealtime Insulin in Patients with Type 2 Diabetes Mellitus with a 6-month Safety Extension Period

Change in HbA1c from baseline to endpoint (scheduled month 6)

Effect of Glycine in Cystic Fibrosis

The aim of this study is to evaluate if glycine, orally administered in a daily dose of 0.5 g/kg during 8 weeks, can ameliorate the airway inflammation in children with cystic fibrosis, as compared with placebo. During all of the study children will receive their usual treatment for cystic fibrosis.

An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients with Prostate Cancer Requiring Androgen Ablation Therapy

To evaluate safety and tolerability during long-term treatment with degarelix one-month dosing regimen in prostate cancer patients

The effect of NEU-P11 on symptoms in patients with D-IBS

The purpose of this study is to evaluate the effect of NEU-P11 on symptoms in patients with D-IBS

Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant

This phase II trial studies how well giving lenalidomide with or without rituximab works in treating patients with progressive or relapsed chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), prolymphocytic leukemia (PLL), or non-Hodgkin lymphoma (NHL). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide together with or without rituximab may kill more cancer cells.

Trial of pasireotideLAR and Topotecan in Relapsed or Refractory Small Cell Lung Cancer

The majority of small cell lung cancer(SCLC)(50-100%) express somatostatin receptors(type 1-5) with some small cell lung cancer express more than one subtypes. Stimulation of these SSTR's lead to inhibition of angiogenesis and cell growth. SOM230 also lower levels of IGF which is known to contribute to SCLC proliferation. Topotecan is approved for second line therapy in relapsed small cell lung cancer. We hypothesized that combination of both agents should yield greater antitumor activity.

Proof of mechanism pre-surgical window trial of metformin in non-diabetic women with endometrial carcinoma: a feasibility study

To determine whether metformin exerts any effect in endometrial cancer.

A phase 1/2a, dose escalation study of CHR-3996 in combination with tosedostat in subjects with relapsed, refractory multiple myeloma

During the dose escalation phase, the purpose of the study is to determine the maximum tolerated dose (MTD) of CHR-3996 and tosedostat administered in combination in subjects with relapsed or refractory multiple myeloma. In the dose expansion phase the purpose of the study is to determine the safety profile of CHR-3996 and tosedostat administered in combination and to estimate the response rate.

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

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

A phase II study in mCRPC on the pharmacodynamic effects of budesonide on cabazitaxel (Jevtana®): A randomised, open-label multicenter study: CABARESC

To study the effects of budesonide on the incidence of cabazitaxel induced diarrhea

An open label, one-arm, multiple dose study in patients with prostate cancer to demonstrate efficacy of a one month goserelin 3.6 mg implant in a two months treatment (2 application periods) and PK/PD analysis of Zoladex® 3.6 mg implant in additional 12 patients.

To demonstrate that Acino Goserelin 3.6 mg implant is effective in achieving and maintaining castration levels of testosterone.

Testosterone Replacement in Young Male cancer Survivors

The principal research question is to find out whether testosterone replacement therapy can reduce body fat and improve quality of life in young male cancer survivors who have a borderline low level of testosterone.

Veliparib (ABT888) Monotherapy for Patients with BRCA germline mutation and Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer

Phase I: To determine: • Maximum-tolerated dose (MTD) • Dose-limiting toxicities (DLT) • Recommended phase II dose Phase II: To investigate the response rate in platinum-resistant and partially platinum sensitive ovarian cancer patients with known BRCA mutations treated with veliparib monotherapy.

A randomized double-blind phase 3 trial comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/doxil®/caelyx®) in combination versus PLD in participants with platinum-resistant ovarian cancer

Compare progression-free survival (PFS), based upon investigator assessment using RECIST v 1.1 in participants with platinum-resistant ovarian cancer who receive combination therapy with EC145 and pegylated liposomal doxorubicin (PLD) (i.e., EC145 + PLD) with that of participants with platinum-resistant ovarian cancer who receive PLD and placebo.

Association Between Hepatitis C Infection and Renal Cell Carcinoma

The purpose of this study is to determine if there is an association between hepatitis C infection and kidney cancer. All patients who are diagnosed with kidney cancer and who will either have a biopsy or surgery will be offered to be tested for hepatitis C. The control group will be colon cancer patients. Both groups would be of recent diagnosis (6 months).

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

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

ION– Is ablative radiOiodine Necessary for low risk differentiated thyroid cancer patients

The principal research question for the phase III trial is to determine whether patient survival rates are no worse (non-inferior) for patients that do not receive Radioactive Iodine (RAI) ablation compared to those that do.

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

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

LUX-Head & Neck 1 - A randomised, open-label, phase III study to evaluate the efficacy and safety of oral afatinib (BIBW 2992) versus intravenous methotrexate in patients with recurrent and/or metastatic head and neck squamous cell carcinoma who have progressed after platinum-based therapy

To investigate the efficacy of afatinib versus methotrexate therapy in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy given for R/M HNSCC

A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis

To demonstrate that the efficacy of each secukinumab regimen at Week 16 is superior to placebo in patients with active Ankylosing Spondylitis based on the proportion of patients achieving an ASAS 20 (Assessment of Spondyloarthritis International Society criteria) response in the subgroup of patients who are TNFα inhibitor naïve

A Multicenter, Randomized, Double- Blind, Placebo-Controlled, Phase 3 Trial of E7080 in 131I- Refractory Differentiated Thyroid Cancer

To compare the progression-free survival of subjects with 131I-refractory differentiated thyroid cancer with radiographic evidence of disease progression within the prior 12 months treated with E7080 versus placebo.

Prognostic Potential of Cell Surface Markers and Pim Kinases in Multiple Myeloma

The purpose of this study is to understand if small proteins found on the surface of myeloma cells (called CXCR4, CD47, and beta 2 adrenergic receptors) can predict how patients will respond to chemotherapy-treatment and if a small molecule inside the myeloma cells (called Pim kinase) can be used as a treatment target for myeloma.

Assessment of Therapeutic Response to Benznidazole in patients with Chronic Chagas Disease by Measuring Plasma Parasite Load and the Specific Immune Response against Trypanosoma cruzi. A Randomized, open label, Pilot Clinical Trial

To compare the evolution of the parasite load at baseline and during therapy with benznidazole and in the following 16 months after therapy, in treated and untreated patients. To compare the evolution of the specific immune response against T. cruzi at baseline and during therapy with benznidazole and in the following 16 months after therapy, in treated and untreated patients.

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

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

An efficacy, safety and pharmacokinetic study on the short-term and long-term use of METFORMIN in obese children and adolescents

The primary objective of the METFORMIN study is to determine the efficacy of metformin in combination with lifestyle-intervention in obese children and adolescents with insulin resistance versus placebo with lifestyle-intervention.

A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead Sponsored Trials in Subjects with Chronic Hepatitis C Infection

To assess the durability of sustained virologic response (SVR) following treatment in a Gilead-sponsored Hepatitis C Study

A Phase III, open-label trial of TMC435 in combination with peginterferon alpha-2a and ribavirin for HCV genotype-1 infected subjects who participated in the placebo group of a Phase II/III TMC435 study (C201, C205, C206, C208, C216 or HPC3007), or who received short-term (up to 14 days) direct-acting antiviral treatment for hepatitis C infection in a selected Tibotec-sponsored Phase I study.

The primary objective is to evaluate the antiviral efficacy of TMC435 in combination with PegIFNalpha-2a and RBV, with respect to the proportion of subjects with SVR24 (1) in the subjects who participated in the placebo group of a Phase II/III TMC435 study, and (2) in the subjects who participated in a selected Tibotec-sponsored Phase I study.

A Phase IIIb, randomized study comparing maintenance therapy with subcutaneous rituximab continued until progression and observation in patients with relapsed or refractory, indolent non-Hodgkin’s lymphoma who completed and responded to a 6-month rituximab-based immunochemotherapy induction and initial 2-year rituximab maintenance therapy administered subcutaneously.

To evaluate the efficacy in term of progression-free survival after randomization (PFSrand) of a subcutaneous (SC) formulation of rituximab in patients who responded to Induction and initial 2 years maintenance therapy (Maintenance I), and were randomized to either prolonged rituximab maintenance until progression (Maintenance II) or observation.

Natural History of Individuals With Immune System Problems That Lead to Fungal Infections

To collect medical information and samples for a long-term study of people with immune system problems that lead to fungal infections.

LUX-Head & Neck 2. A randomised, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemoradiotherapy in primary unresected patients with stage III, IVa, or IVb loco-regionally advanced head and neck squamous cell carcinoma

To investigate the efficacy and safety of afatinib compared to placebo as adjuvant therapy after chemo-radiotherapy in patients with loco-regionally advanced head and neck squamous cell carcinoma. Efficacy will be measured by comparing Disease Free Survival (DFS) between the two arms.

An open-label, multi-center, expanded access study of everolimus in patients with advanced neuroendocrine tumors

To evaluate additional safety of everolimus in patients with advanced neuroendocrine tumors of pancreatic origin.

A trial of Prostate Radiotherapy in Conjunction with Carbogen and Nicotinamide (PROCON)

We propose a study to test whether it is possible to improve the outcome of prostate radiotherapy using simple, cost-effective measures. Carbogen gas (98% oxygen and 2% carbon dioxide) and nicotinamide (vitamin B3) will be given in conjunction with standard prostate radiotherapy. Disease control, survival and toxicity will be measured. The study aims to determine the efficacy of carbogen gas breathing and nicotinamide tablets, given during a course of intensity-modulated radiotherapy to the prostate gland in previously untreated patients with prostate cancer.

Distribution of Human Papillomavirus (HPV) Genotypes in Patients With Cervical Cancer From Croatia (HPV-cancer)

The aim of this study is to describe the pre-vaccination distribution of HPV genotypes in women with high grade cervical squamous intraepithelial lesion (HSIL) and cervical cancer in Croatia.

Efficacy, tolerability and safety of Temsirolimus in women with platinum-refractory ovarian carcinoma or advanced endometrial carcinoma

To assess the progression-free survival rate after 4 months (recurrent ovarian cancer) or 6 months (endometrial cancer)

Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation

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

Utility of XCL1 as a Prognostic Marker in Acute Lymphoblastic Leukemia

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

A Phase III, open-label, multicentre, randomised trial to establish safety and efficacy of an EGF cancer vaccine in inoperable, late stage (IIIb/IV) NSCLC patients eligible to receive standard treatment and supportive care

To assess overall survival (OS) of an EGF cancer vaccine in inoperable, late stage (IIIb/IV) NSCLC patients when compared to the control group receiving best treatment and supportive care.

Characterization of focal liver lesions with Sonovue(R)-enhanced ultrasound imaging: a phase III, intrapatient comparative study versus unenhanced ultrasound imaging using histology or combined imaging/clinical data as truth standard.

To demonstrate the sensitivity and specificity of Sonovue-enhanced ultrasound is superior to that of unenhanced ultrasound for the characterization of benign versus malignant focal liver lesions (FLLs) using final diagnosis based on histology or combiend imaging (CE-CT and/or CE-MRI)/clinical data as truth standard.

A multi-center, randomized, open-label, mechanism of action trial on the biological effects of the therapeutic cancer vaccine Stimuvax® (L-BLP25) in rectal cancer subjects undergoing neoadjuvant chemoradiotherapy. Stimuvax® (L-BLP25) in rectal cancer in neoadjuvant chemoradiotherapy (SPRINT)

The primary objective of the trial is to evaluate whether L-BLP25 administered as weekly subcutaneous vaccinations with or without pretreatment with intravenous cyclophosphamide (CPA) induces a change in immune response parameters (ELISpot against carcinoembryonic antigen [CEA] and mucinous glycoprotein 1 [MUC1], tumor-infiltrating lymphocytes [TILs]) in subjects with rectal cancer undergoing neoadjuvant chemoradiotherapy. The immune response will be evaluated based on the local response in the tumor and the MUC1- and CEA-specific response tested in blood. CEA-specific immune response will indicate antigen spreading.

MR Image Guided Therapy in Prostate Cancer

To test the safety and effectiveness of treating prostate tumors with laser therapy guided by magnetic resonance imaging.

A prospective randomised Phase III trial to evaluate optimal treatment duration of first-line bevacizumab in combination with carboplatin and paclitaxel in patients with primary epithelial ovarian, fallopian tube or peritoneal cancer.

To compare progression-free survival (PFS) (by RECIST v1.1, clinical or symptomatic) of patients randomized to front-line paclitaxel/carboplatin with bevacizumab for 15 months or 30 months.

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

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

Dopamine on top of standard treatment for patients with exacerbation of Heart Failure, at home situation

The main objective of this trial is to compare dopamine versus no dopamine on top of standard treatment in patients with exacerbation of severe heart failure (NYHA class III-IV) in home situation. This study will investigate whether 24 hour dopamine infusion reduces the need of hospital admission for patients with exacerbation heart failure

Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer

This is a pilot study which primary end point is evaluating the effect of Abraxane in combination with gemcitabine on tumor stroma, and the secondary end-point is correlating these changing with treatment activity.

Economic Evaluation of Three Populational Screening Strategies for Cervical Cancer (CRICERVA)

The aim of this study was to compare the effectiveness and the costs of three types of population interventions to increase the number of female participants in the screening programmes for cancer of the cervix carried out by Primary Care in four Basic Health Care Areas.

Evaluation of the efficacy of Pregabalin for the treatment of evoked and non-evoked neuropathic pain at the level of the spinal cord injury during the early and late sub-acute phase of the spinal cord injury.

To evaluate the efficacy of Pregabalin for the treatment of evoked and non-evoked neuropathic pain at the level of the spinal cord injury.

UsTekinumab for the treatment Of Patients with active Ankylosing Spondylitis (TOPAS) – a 28-week, prospective, open-label, proof-of-concept study

Evaluation of efficacy and safety of ustekinumab 90 mg administered subcutaneosly at week 0, week 4 and week 16 in patients with active AS (the Bath Ancylosing Spondylitis Disease Activity Index – BASDAI ≥4) fulfilling the modified New York criteria who have had an inadequate response to ≥2 NSAIDs or do not tolerate or have a contraindication for NSAIDs.

Safety and Efficacy Study of PEA and Polydatin on Intestinal Inflammation and Visceral Hyperalgesia in Irritable Bowel Syndrome (IBS) Patients (CMD-IBS09(2))

The aim of this pilot study is to provide evidence of: - intestinal mast cell (MC) infiltration and activation in IBS patients; - down-modulation of MC activation by the oral administration of the association of palmitoylethanolamide (PEA) and polydatin in IBS patients.

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

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

Ultrasound Elastography in Patients With Rectal Cancer

The purpose is to elucidate ultrasonic elastography's ability to predict treatment response at an early stage by comparing quantitative ultrasound parameters before, during and after treatment with MR scan results and histopathological Tumor Regression Grade (TRG score) after operation.

A randomized, double-blind, placebo-controlled multi-center study of BYM338 for treatment of cachexia in patients with stage IV non-small cell lung cancer or stage III/IV adenocarcinoma of the pancreas

To assess the preliminary efficacy of a single intravenous dose of BYM338 in increasing thigh muscle volume as assessed by Magnetic Resonance Imaging compared to placebo.

Trial of Radiation Therapy "Sandwiched" Between Chemotherapy to Treat Uterine Carcinosarcoma

The purpose of this study is to determine whether radiation therapy "sandwiched" between paclitaxel/carboplatin chemotherapy is effective in the treatment of uterine carcinosarcoma,and particularly whether this treatment will lessen the chance of the cancer returning in the pelvis or elsewhere in the body.

Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study

The purpose of this observational study is to prospectively monitor the outcome associated with men who meet the eligibility criteria for low risk prostate cancer and elected to participate in the active surveillance program at The Center for Cancer Prevention and Treatment at St. Joseph Hospital.

Trial of Radiation Therapy "Sandwiched" Between Chemotherapy to Treat Uterine Carcinosarcoma (MMMT)

The purpose of this study is to determine whether radiation therapy "sandwiched" between paclitaxel/carboplatin chemotherapy is effective in the treatment of uterine carcinosarcoma,and particularly whether this treatment will lessen the chance of the cancer returning in the pelvis or elsewhere in the body.

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease

The primary objectives are: - To evaluate clinical remission for the 2 SC maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn’s disease induced into clinical response with ustekinumab in the induction studies, CNTO1275CRD3001 and CNTO1275CRD3002. - To evaluate the safety of 2 SC maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn’s disease.

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

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

Sexual Behavior in Head and Neck Cancer Patients

The goal of this behavioral research study is to learn if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (HPV-16). Knowing this information could help doctors better teach patients about avoiding certain risk factors, which may help to prevent the disease.

A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease

The primary objective: Part A / To evaluate the effect of TRK-170 on mucosal healing as measured by Crohn's Disease Endoscopic Index of Severity (CDEIS) score based on ileocolonoscopy and use this evaluation to decide which dose(s) of TRK-170 should be used in Part B Part B / To evaluate the efficacy of TRK-170 in patients with active CD as measured by CDAI score

An open-label, single-arm, phase II, multicenter study to evaluate the efficacy of vemurafenib in metastatic melanoma patients with brain metastases

To evaluate the efficacy of vemurafenib using Best Overall Response Rate (BORR), as assessed by an Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST, v1.1) in the brain of metastatic melanoma patients with previously untreated brain metastases

Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients

The primary objective of the study is to determine the prevalence of aspirin resistance in chronic kidney disease patients. The secondary objectives are to determine possible risk factors contributing to aspirin resistance in this population.

Randomized, Open Label, Multi-Center Study comparing Cabazitaxel at 25 mg/m2 and at 20 mg/m² in Combination with Prednisone Every 3 Weeks to Docetaxel in Combination with Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer not Pretreated with Chemotherapy

To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m² (Arm A) or 20 mg/m² (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in patients with metastatic castration resistant prostate cancer (MCRPC) and not previously treated with chemotherapy

Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer

The primary objective of this study is to estimate whether the addition of trastuzumab to paclitaxel and carboplatin chemotherapy improves progression free survival when compared to paclitaxel and carboplatin alone in Uterine Serous Papillary Carcinoma (USPC) patients overexpressing Her2/neu at 3+ level by immunohistochemistry (IHC)or positive by fluorescence in situ hybridization (FISH).

A clinical and mechanistic proof of efficacy study with belimumab in chronic immune thrombocytopenia (ITP) patients

To evaluate whether belimumab can demonstrate clinical efficacy in ITP and To evaluate whether belimumab can modulate anti-platelet autoantibodies in patients with detectable baseline levels of these antibodies

Panitumumab after Resection of Liver Metastases from Colorectal Cancer in KRAS Wild-type Patients -PARLIM-

The study aims to assess the efficacy of postoperative therapy with FOLFOX plus panitumumab followed by maintenance with panitumumab for 3 months in KRAS wild-type patients, compared to the historical data for standard FOLFOX chemotherapy alone, which are verified by a randomised control group without the antibody.

A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma

This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with and without gemcitabine.

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

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

Phase 2 Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects with Locally-advanced Pancreatic Cancer

The main objective of the trial is to compare overall survival (OS) of subjects with locallyadvanced pancreatic cancer (LAPC) who are randomized to receive dasatinib added to standard of care (gemcitabine [GEM]) versus standard of care (GEM) plus placebo

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

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

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

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

Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE) (ROCITP2)

This multicentre, prospective cohort study aims to test the following hypotheses: - Antepartum prophylaxis with fixed-dose low molecular-weight heparin (LMWH) is safe, convenient and associated with an acceptably low risk of recurrent VTE in women with a single prior episode of VTE that was either unprovoked or associated with a minor transient risk factor. (Moderate risk cohort) - Withholding antepartum prophylaxis is safe (recurrence risk <1%) in pregnant women with a single prior episode of VTE provoked by a major transient risk factor. (Low risk cohort)

A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus

The primary objective of this study is to evaluate the efficacy of sifalimumab compared to placebo in subjects with chronic, moderately-to-severely active SLE.

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

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

NGR018: Randomized phase II study of NGR-hTNF plus pegylated liposomal doxorubicin (PLD) versus PLD in platinum-resistant ovarian cancer

To compare progression-free survival (PFS) in patients randomized to NGR-hTNF plus PLD versus patients randomized to PLD

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

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

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

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

An Open-Label, Multi-Center Phase II Study of the BRAF Inhibitor RO5185426 in Patients with Metastatic or Unresectable Papillary Thyroid Cancer (PTC) positive for the BRAF V600 Mutation and Resistant to Radioactive Iodine

To evaluate best overall response rate (BORR) (complete + partial response) in Cohort 1 (sorafenib-naïve patients).

Intra-hepatic and systemic chemotherapy with or without antibody for patients with non-resectable liver metastasis from solid tumours

This study aims to evaluate the tumour response

Costimulatory Molecules as Biomarkers in Cystic Fibrosis

The purpose of this study is to investigate the expression of a certain class of molecules, called costimulatory molecules, in humans with Cystic Fibrosis. Cystic Fibrosis is a genetic disorder which renders the lung susceptible to persistent inflammation which, at times, can worsen, resulting in accelerated decline in lung function and eventually death or transplant. Our goal is to determine if the levels of costimulatory markers can be used to predict exacerbation and subsequent lung function decline in subjects with Cystic Fibrosis.

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

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

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

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

Radiofrequency Ablation Versus Hepatic Resection for the Treatment of Hepatocellular Carcinomas Smaller Than 2 cm

Recently, a clinical trial has shown that PRFA is as effective as HR for small HCC in terms of overall survival and disease-free survival. This has prompted some authors to suggest that PRFA could be more suitable than HR for early stage HCC. Some authors also have suggested that PRFA can be considered the treatment of choice for patients with single HCC ≤ 2.0 cm, even when HR is possible. On the other hand, some tumors (subcapsular location, adjacent to intestinal loops or main bile ducts) may be unsuitable for PRFA because of the risk of bleeding, tumor seeding, bile leakage, perforation, and so on. Furthermore, in our previous experience, some tumors (with deep locations, which were included as "central HCC") may be also unsuitable for HR because of risks of more injury of normal liver tissue, blood loss after resection, and so on. Therefore, the appropriate therapeutic option for these HCC tumors ≤ 2 cm, especially for central HCC, is still under debate. To clarify this issue, the investigators conducted a study that included a consecutive series of patients with single resectable HCC < 2.0 cm in diameter, who underwent PRFA or HR.

A multicenter, phase III, open-label, randomized study in previously untreated patients with advanced indolent non-hodgkin's lymphoma evaluating the benefit of GA101 (RO5072759) plus chemotherapy compared with rituximab plus chemotherapy followed by GA101 or rituximab maintenance therapy in responders

Progression-free survival in patients with follicular lymphoma, investigator-assessed according to the Revised Response Criteria for Malignant Lymphoma up to 7.5 years

A Trial to Evaluate the Improvement in Lung Cancer Patients Receiving Radiation With or Without Brachytherapy (BRACHY)

A trial to improve the quality of life of patients with advanced non-small cell lung cancer (NSCLC) by evaluating the symptomatic improvements in lung cancer patients receiving external radiation with or without high dose internal radiation.

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

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

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

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

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

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

Rasagiline treatment for Sleep disorders in Parkinson´s disease

Reduction of sleep disturbances

Biomarkers in Blood and Tissue Samples From Patients With Uterine Cancer

This research study is studying biomarkers in blood and tissue samples from patients with uterine cancer.

Twelve-month study on the immunogenicity, safety, and efficacy of Zarzio®/Filgrastim HEXAL® in patients with severe chronic neutropenia

The primary objective of this study is to evaluate the immunogenicity of long-term treatment of SCN patients with Sandoz’ filgrastim in terms of the incidence of anti-rhG-CSF antibodies.

Randomized Multicentre Phase III study of short course radiation therapy followed by prolonged pre-operative chemotherapy and surgery in primary high risk rectal cancer compared to standard chemoradiotherapy and surgery

To increase the disease-free survival after 3 years follow-up

A Phase I/II, Multi-centre Trial to Assess the Safety, Efficacy, and Pharmacokinetics of Eltrombopag, Administered to Thrombocytopenic Chronic Lymphocytic Leukemia Patients Prior to Alkylating Agents and/or Purine Analogue-based Therapy

Phase I: The primary objective is to find the safe and potentially efficacious dose of eltrombopag to achieve a durable increase in platelet count. Phase II: The primary objective of phase II is to confirm the effect of the selected dose from Phase I in correcting thrombocytopenia to enable patients to receive alkylating agents and/or purine analogue-based therapy.

A Phase 2 Study of a Human Anti-PDGFRα Monoclonal Antibody (IMC-3G3) in Previously Treated Patients with Unresectable and/or Metastatic Gastrointestinal Stromal Tumors (GIST)

The primary objective of this study is to evaluate the tumor response of stable disease (SD) or better at 12 weeks in two separate cohorts representing molecularly distinct subsets of previously treated patients with GIST when treated with IMC-3G3: Cohort 1 includes patients with GIST harboring PDGFRα mutations (D842V and any others), while Cohort 2 includes patients with GIST not harboring PDGFRα mutations.

A Study of the Safety and Efficacy of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia

The primary objective of this study is to evaluate the safety and tolerability of ONO-7746 across multiple doses in patients with solid tumors and chemotherapy induced thrombocytopenia (CIT) receiving the combination of carboplatin and paclitaxel chemotherapy (with or without trastuzumab for breast cancer patients).

An open-label, multicenter Phase Ib/2 study of E7080 alone, and in combination with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted treatment.

Phase Ib: To determine the dose limiting toxicities and maximally tolerated dose and establish the recommended phase 2 (RP2) dose for E7080 incombination with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma (RCC). Phase 2: To compare the progression free survival of 1) E7080 in combination with everolimus at the RP2 dose once daily (Arm A) and 2) single agent E7080 24 mg once daily (Arm B) to single agent everolimus 10 mg once daily (Arm C) in subjects with unresectable advanced or metastatic RCC and disease progression following one prior VEGF targeted treatment.

A single-arm, open-label, phase 2 clinical trial evaluating disease response following treatment with intravenous BHQ880, a fully human, anti-Dickkopf1 (DKK1) neutralizing antibody in previously untreated patients with high-risk, smoldering multiple myeloma

Assess the overall response rate after BHQ880 treatment in previously untreated patients with high-risk SMM

Randomised controlled open-label trial of TPF induction chemotherapy in the surgical management of locally advanced head and neck cancer

The primary aim is to determine whether enough patients agree to be randomised in this feasibility study so that the full phase III would be able to recruit the target sample size within 4 more years. This will be determined by setting up at least 4 centres, each of which should recruit an average of 1 patient per month during a 12 month period.

Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer

This study is intended to assess the feasibility of adjusting a radiation plan during its course to accommodate for a shrinking tumor target. The investigators hypothesize that an adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with chest-confined disease will allow for safe delivery of higher doses of chest RT than a non-adaptive RT planning approach without subjecting normal critical structures to unacceptable doses of radiotherapy.

An open-label, Phase I/IIa, dose escalating study of 2B3-101 in patients with solid tumors with or without brain metastases.

To assess the safety and tolerability of 2B3-101 when administered intravenously (IV) in patients with solid tumors with our without brain metastases in order to determine the Maximum Tolerated Dose (MTD).

A phase III, open-label study of once daily BI 201335 240 mg for 24 weeks in combination with pegylated interferon-α (PegIFN) and ribavirin (RBV) in patients with genotype 1 chronic hepatitis C infection who failed a prior PegIFN / RBV treatment

To offer patients with virological failure in the placebo controls of the Phase III trials 1220.7, 1220.30 and 1220.47 open label treatment with BI 201335, PegIFN and RBV.

Safety of Vorinostat in combination with Bortezomib, Doxorubicin and Dexamethasone (VBDD) in patients with refractory or relapsed multiple myeloma

Primary objective of the study is the determination of the maximum tolerated dose (MTD) of Vorinostat (V), given in combination with fixed doses of Doxorubicin (D), Bortezomib (B) and Dexamethasone (D).

Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia