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Dose-escalation by boosting radiation dose within the primary tumor on the basis of a pre-treatment FDG-PET-CT scan in stage IB, II and III NSCLC: A randomized phase II trial

The primary objective of this study is to determine the freedom from local failure in patients alive at 1 year

Employing dynamic kinetic responses to demonstrate the effectiveness of dietary intervention: A challenge-based study using a low-glycaemic load diet

Primary objective: To assess the impact of a low glycaemic load (GL) diet as compared to a *Western* diet on metabolic flexibility (the change in RQ) upon a hyperinsulinemic euglycemic clamp. Secondary objectives: 1) To assess the impact of low GL…

An open-label, parallel-group, single-dose study to evaluate the absolute bioavailability and tolerability of subcutaneous UCB4940 in healthy subjects

The purpose of the study is to investigate how quickly and to what extent an injection under the skin (subcutaneous [sc]) of UCB4940 is absorbed and eliminated from the body (this is called pharmacokinetics) in comparison with the absorption and…

An open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA)

Primary:To evaluate if the proportion of patients in clinical remission on canakinumab 4mg/kg (+/- concomitant NSAID only) who are able toremain on a reduced canakinumab dose (2mg/kg every 4 weeks) or prolonged canakinumab dose interval (4mg/kg…

RCT to investigate the quality of the of endometrial sample obtained by aspiration when performed before or after the SIS in postmenopausal women.

The primary objective is to investigate the quality (whether assessable by a pathologist or not) of the endometrial sample obtained by aspiration when performed directly before or after the SIS in postmenopausal women. Secondary objectives are to…

A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients with Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses

Primary Objective:To characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in patients with CP-CML who are resistant to at least 2 TKIs, as measured by MCyR by 12 months.Key Secondary Objectives:* To…

PROMOTION-trial: A PROspective randomized Multicenter trial for the treatment of dislocated 3- and 4-part proximal humerus fractures: Open reduction and internal plate fixaTION versus intramedullary nailing.

Goal of this trial is to point out the surgical intervention with the best functional outcome.

The effect of blood flow restriction with and without resistance exercise on muscle protein synthesis

The main aim of the current study will be to assess the effect of acute blood flow restriction and blood flow restriction combined with resistance exercise on the muscle protein synthetic rate in healthy young male subjects

Mitochondrial Oxygen Tension Improves not upon Fluid Administration but after Transfusion of Erythrocytes (MOTIFATE)
in chronic anemia patients
(a pilot study)

The study will compare the change in cutaneous cellular oxygen availability, measured as mitochondrial PO2 (mitoPO2) between a fluid challenge and a blood transfusion in chronic anemia patients.

Managing Thrombocyte transfusions in a Special Subgroup: NEonates

To assess whether a higher prophylactic platelet transfusion threshold is superior to the lower thresholds in reducing the proportion of patients who experience a major bleed or death up to study day 28.

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

The primary objective of this trial is to evaluate the efficacy of vemurafenib using BestOverall Response Rate (BORR), as assessed by an Independent Review Committee (IRC)using RECIST, v1.1 criteria in the brain of metastatic melanoma patients with…

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 Incorporates Amendment 02 and Administrative Letter 01 and 02;+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 11-Sep-12)

Primary Objectives:The primary objective for this study is 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.Secondary…

Skin sparing mastectomy with implant reconstruction: clinical outcomes and cost effectiveness of reconstruction in one stage with the use of a collagen matrix. A randomized clinical trial.

A novel one-stage procedure where definitive implants are combined with a collagen matrix is compared to the traditional two-staged procedure where a tissue expander is placed before an implant. Our hypotheses are the following:The use of a collagen…

BRALAV-study: Breast Reconstruction; Added Layer, Added Value?

The aim of this study is to compare clinical outcomes and cost-effectiveness of two procedures for skin sparing mastectomy with implant reconstruction in a randomized clinical trial. The customary method for one-stage breast reconstruction with…

An Extension Protocol for Participants of Genzyme-Sponsored;Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study of Matrix-Induced Autologous Chondrocyte Implantation (MACI® implant) for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea

The objective of this study is to examine the 5-year efficacy and safety of Matrix-Induced Autologous Chondrocyte Implantation (MACI® Implant), compared with arthroscopic microfracture, in patients who received study treatment in Genzyme-sponsored…

Investigating the role of the Extrastriate Body Area in motor planning - an explorative TMS-study

Here, we want to investigate the role of EBA in planning and control of goal-directed actions using transcranial magnetic stimulation (TMS) and investigate whether EBA plays a crucial role in planning of goal-directed action by providing an early…

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

PrimaryThe primary objective of the study is to evaluate the rate of AF recurrences one month after randomization according to different timings of initiation of dronedaroSecondaryThe secondary efficacy objective is to evaluate the rate of AF…

A randomized phase II study for the evaluation of T cell depleted non-myeloablative
allogeneic stem cell transplantation followed by early consolidation with lenalidomide
or lenalidomide combined with bortezomib and subsequent DLI for patients with
multiple myeloma in progression or relapse following first line therapy

Primary objective:Assesment of feasibility and toxicity of T cell depleted NMA Allo-SCT followed by lenalidomide or lenalidomide combined with bortezomib,and subsequent DLI; as treatment of relapsed multiple myeloma.Secondary objectives:To…

A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symptoms

The objectives of this open-label study are to evaluate the efficacy (GL-3 clearance), pharmacokinetics (PK), and safety parameters (including immunogenicity) for 2 alternative dose regimens of Fabrazyme (0.5 mg/kg every 2 weeks [q2w] and 1.0 mg/kg…

An Open-Label, Randomized, Multicenter Phase IIa Study;Evaluating Pertuzumab in Combination with Trastuzumab and;Chemotherapy in Patients with HER2-Positive Advanced;Gastric Cancer

Pertuzumab is an investigational agent being studied for the treatment of HER2-positive gastric cancer. This study intends to provide a dose of pertuzumab to find an acceptable minimum pertuzumabconcentratie pertuzumab effective when administered in…