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A phase 1 multicenter, open label, dose-escalation study of oral LEE011 in patients with advanced solid tumors or lymphomas.

Primary To determine the maximum tolerated dose (MTD) and characterize the dose-limiting toxicities (DLT) of LEE011 when administered orally once daily for 21 consecutive days followed by a 7 day break.Secondary *Safety and tolerability of LEE011.*…

An open-label, multi-center, three arm randomized, phase III study to compare the efficacy and safety of RO5072759 + chlorambucil (GClb), rituximab + chlorambucil (RClb)or chlorambucil (Clb) alone in previously untreated CLL patients with comorbidities.

The primary objective of the study is to demonstrate clinically relevant statistical superiority in progression-free survival (PFS) with GClb compared to RClb and Clb alone and RClb compared to Clb [GClb vs Clb; GClb vs RClb; RClb vs Clb] in…

A double-blind, placebo-controlled, randomized trial to study the Viaskin® Peanut*s Efficacy and Safety for treating peanut allergy in children and adults.

· To determine the efficacy of several doses of Viaskin® Peanut to significantlydesensitize peanut-allergic subjects to peanut after 12 months of EPIT treatment .· To evaluate the safety of a long-term EPIT with Viaskin® Peanut.

A randomized, controlled, open-label, parallel-group, multi-center study to compare the effect of Intrathecal Baclofen Therapy (ITB Therapy®) versus Best Medical Treatment (BMT) on spasticity in post-stroke patients after 6 months active treatment

The objective is to determine whether ITB Therapy is more effective than oral anti-spasticity agents in reducing the spasticity.

Joint distraction in treatment of knee osteoarthritis: a comparison with a presently applied surgical alternative: total knee prosthesis

Primary:- To test the hypothesis that the clinical effect of KJD (determined by WOMAC) is not (clinically relevant) different from TKP at 2 years post treatment (equivalence hypothesis). Secondary:- To describe and compare the clinical efficacy over…

Perioperative antibiotic use in the treatment of acute calculous cholecystitis

To demonstrate that extended postoperative antibiotic treatment does not decrease the infectious complication rate in laparoscopic cholecystectomy for acute cholecystitis.

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).

Physical fitness levels of wheelchair-bound children and adolescents with osteogenesis imperfecta: a feasibility and reliability study

To investigate whether children with OI who use a wheelchair (for long distances) can reliably perform a valid shuttle ride test in order to assess the levels of health-related fitness in this group.

Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD)

The objective of this extension study is to find out the potential long-term benefits and safety of tolvaptan. During this study all participants will receive tolvaptan.PRIMARY OBJECTIVE is to demonstrate whether tolvaptan modifies ADPKD progression…

Weekly administration of Oral Docetaxel in combination with Ritonavir

To determine the maximum tolerated dose (MTD), dose limiting toxicities (DLT), and optimal dose of docetaxel that can safely be administered to patients with cancer in a weekly schedule. amendment 1The objective of the first amendment is to…

In vivo analysis of tibial rotation after anatomical versus trans-tibial anterior cruciate ligament reconstruction surgery

Theoretically the anatomical reconstruction technique should give better results in rotational stability due to a more anatomical placement of the ACL-graft. Though it is difficult to test this correlating to functional outcome, because in current…

Development of Tools (and prediction rules) to time and select therapy in treatment of pre-clinical, early and established Rheumatoid Arthritis: Creating Enhanced Remedy (TRACER): established reumatoid arthritis

to combine and validate diagnostic tests for the prediction of clinical response to therapy with biologics in patients with reumatoid artritis.

Effectiveness of Autonomy-Groups in Patients with Anxiety Disorders: A RCT

ObjectiveTo investigate the effectiveness of autonomygroups for (Dutch) patients with anxiety disorders.Research questions(1) *Do patients with anxiety disorders show a significant increase of autonomy after the autonomygroup?*(2) *Do patients with…

A Randomized, Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy.

Primary Objective* To compare the objective response rate and overall survival of BMS-936558 to investigator*s choice in subjects with advanced melanoma.Secondary Objectives* To compare the progression-free survival (PFS) of BMS-936558 to…

MINIMAL INVASIVE MONITORING OF VOLUME STATUS IN PATIENTS AFTER MAJOR ABDOMINAL SURGERY.

The primary objectives of this study consist of:1. To assess the accuracy of different pulse contour methods to measure CO compared to thermodilution CO measured with a PAC in major abdominal surgery patients.2. To assess the effect of propofol…

Vitamin D and non-specific musculoskeletal complaints in non-Western immigrants

We aim to assess the effect of high-dose vitamin D supplementation on non-specific musculoskeletal complaints in non-Western vitamin D-deficient immigrants and to determine whether improvement of mood is associated with this effect.

Improvement of working memory, attention and concentration after neonatal intensive care: a randomized controlled intervention study

• To evaluate short-term (directly after training) and long-term (12 months) effects of cognitive rehabilitation on (working)memory, attention, concentration, and quality of life; measured by neuropsychological assessments, and reports by parents…

A phase III, randomized, controlled, single-blind, multicentre, parallel arm trial to assess the efficacy and safety of Pergoveris® (follitropin alfa and lutropin alfa) and GONAL-f® (follitropin alfa) for multifollicular development as part of an assisted reproductive technology treatment cycle in poor ovarian responders, as defined by the European Society of Human Reproduction and Embryology criteria

The primary objective of the trial is to demonstrate superiority of Pergoveris® versus GONAL-f® in poorovarian response (POR) patients defined according to modified criteria set forth by the European Society of Human Reproduction and Embryology (…

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…

A prospective Randomized Single Blinded Clinical Study on TKA
with and without Orthosensor

The current study evaluates the OrthoSensor and investigates whether the combination of the Vanguard® Knee System with the OrthoSensor results in a faster recovery and better clinical outcomes during short follow up compared to conventional TKA (…