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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…

A randomized, double-blinded, regimen controlled, phase II, multicenter study to assess the efficacy and safety of two different vismodegib regimens in patients with multiple basal cell carcinomas (BCCs).

The primairy objective of this fase II study, is to compare two treatment regimens of vismodegib in two populations of patients with multiple BCC's (patients with Gorlin syndrome and patients who do not have Gorlin syndrome). Primary to assess…

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…

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…

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…

A Randomized, Double Blind, Single Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of ONS-3010 (Adalimumab, Oncobiologics, Inc.) Compared to Two Reference Products of Humira® (Abbvie) in Healthy Adult Subjects

Primary ObjectiveTo demonstrate pharmacokinetic comparability of ONS-3010 (Oncobiologics), US-licensed Humira®, and EU-licensed Humira® following a single 40-mg subcutaneous (SC) dose in healthy adult subjects.Secondary ObjectiveTo evaluate the…

A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC-0156-0000-0009 when used for Treatment and Prophylaxis of Bleeding Episodes in Patients with Haemophilia B

Primary Objective: To evaluate the immunogenicity of N9-GP.Key Secondary Objectives: * To evaluate clinical efficacy of haemostasis (treatment of bleeding episodes) of N9-GP.* To evaluate clinical efficacy of N9-GP in long term bleeding prophylaxis…

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…

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…

PEEP resuscitation in preterm neonates, a double blinded, randomized, controlled trial comparing 5cmH2O and 8cmH2O PEEP.

In this multicenter trial we compare resuscitation of preterm neonates with either 5 cm H2O PEEP or 8 cmH2O PEEP. We think resuscitation with 8 cmH2O PEEP results in a better outcome compared to resuscitation with 5 cmH2O PEEP.

Sweet and Salt preferences in children that started weaning exclusively with fruit or with vegetables.

Objective: The main objective is to test the preference for sweet and saltwater solutions in infants that started weaning exclusively with fruit or with vegetables. Acceptance of sweet and salt intensity is compared between the fruit and vegetable…

An Investigator Initiated, Controlled, Prospective, Non-Inferiority, Parallel-Group, randomised, Interventional, Open, Blinded Outcome Assessment (PROBE-Design), Multi-centre Trial, Comparing Efficacy and Safety of Isolation of the Pulmonary Veins with a Cryoballoon Catheter Versus a Radiofrequency Ablation with a ThermoCool Catheter in Patients with Paroxysmal Atrial Fibrillation

Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation (AF).