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A phase III randomized study of preoperative radiotherapy plus surgery versus surgery alone for patients with retroperitoneal sarcoma (RPS)

To assess whether preoperative radiotherapy, as an adjunct to curative-intent surgery, improves the abdominal local recurrence-free survival.

Efficacy of EMDR Resource Development and Installation in the stabilization phase of treatment of complex posttraumatic stress disorder

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A prospective Randomized Controlled Trial to Evaluate the Primary Prevention of sudden cardiac death using implantable cardioverter defibrillators in dialysis patients.

The main objective of this study is to assess whether ICD therapy in dialysis patients reduces sudden (arrhythmogenic) cardiac death. The first secondary end point is to compare total mortality death between the two groups. An other is to evaluate…

Reducing symptoms of depression and anxiety in adolescents with inflammatory bowel disease in order to improve quality of life and the clinical course of disease

The primary objective is to determine the efficacy of a disease specific cognitive behavioral therapy program in adolescents with IBD and increased symptoms of depression or anxiety on reducing symptoms of depression. Secondary objectives are to…

The use of Fibrin sealant In total knee Replacement Surgery Trial. A prospective randomised multicentre study.

Is the application of CryoSeal (CS) in primary total knee replacement surgery beneficial for the patient with respect to a faster track and improved postoperative rehabilitation. The beneficial effect may be due to quicker functional knee…

Explaining plasticity after stroke

EXPLICIT aims tot obtain better functional outcome by early intensive rehabilitation. Next to clinical tests to measure improvement in function, neuroplasticity is assessed by fMRI, TMS and haptic robots. The combination of clinical outcome measures…

Augmenting response to entecavir using a temporary peginterferon alpha-2a add-on strategy for the treatment of HBeAg-positive chronic hepatitis B (ARES study)
- Long-term follow-up of a peginterferon alpha-2a add-on strategy in chronic hepatitis B patients treated with entecavir

To investigate the use of a temporary peginterferon alpha-2a add-on strategy during entecavir therapy in patients with HBeAg-positive chronic hepatitis B by comparing the efficacy of this regimen versus entecavir monotherapy.To evaluate the long-…

Disrupting the rythm of depression: effectiveness and cost-effectiveness and mediating factors of preventive cognitive therapy, with or without antidepressants and compared to antidepressants alone, in the prevention of recurrent major depressive disorder.

The objective of this study is threefold:1) compare the effectiveness and cost-effectiveness of brief CT added to maintenance AD versus maintenance AD alone versus guided tapering or discontinuation of AD with brief CT.2) examine whether the…

Pulmonary Rehabilitation of COPD: a trial of sustained internet based self-management support

Research QuestionWhat is the long-term effectiveness and cost-effectiveness of self-management support via an internet based service in addition to usual care as compared to usual care alone in patients with COPD who have completed pulmonary…

TELEHYPE TELEmonitoring and self-management of uncontrolled HYPErtension

To assess the one-year (cost)effectiveness of telemonitoring of blood pressure and self-management support via an internet-based service in addition to usual care as compared to usual care alone in a pragmatic trial in patients with uncontrolled…

(Cost) Effectiveness of Surgery versus Prolonged Conservative Treatment in Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis

Intermittent neurogenic claudication due to lumbar stenosis is frequently diagnosed among older persons. Due to an aging population it is to be expected the incidence of lumbar stenosis will increase over time. Patients are operated on because of…

HARP II-trial: Right-sided hand-assisted retroperitoneoscopic live donor nephrectomy versus standard laparoscopic living donor nephrectomy.

To determine the best approach for right-sided live donor nephrectomy i.e. to optimise donor*s safety and comfort .

Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn*s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

Primary ObjectiveThe primary objective of this study will be to compare the efficacy of infliximab with that of placebo in the prevention of clinical recurrence of CD through Week 76, defined as a composite endpoint that requires endoscopic…

Double-blind, placebo-controlled, multiple ascending-dose study to investigate the safety and tolerability of AZ01 in healthy volunteers.

Primary:- assess safety and tolerability and determine the maximum tolerated dose (MTD) of repeated doses or a single dose of AZ01 given as a subcutaneous (SC) or intravenous (IV) dose in healthy subjects. Dosing will not exceed the maximum feasible…

Sking hardening in polymorphic light eruption. Comparison of therapeutic effect of UVB hardening in the hospital with treatment at home with Sunshower

In this study we will evaluate the effect of Sunshower Medical device at home and compare it with the effect of customary UV hardening performed in the hospital to assess whether the former is not inferior to the latter treatment. The ultimate goal…

A randomized, open-label, comparative, multicenter trial to compare the effects on metabolic parameters of two NOMAC-E2 batches (pivotal phase III and commercial batch) and a monophasic COC containing 150 µg LNG and 30 µg EE (Phase III, Protocol No. P06447)

To compare the effects on the APC- (Activated Protein C) resistance ratio (ETP-[endogenous throbin potential] based) between the pivotal phase III NOMAC-E2 batch and a commercial NOMAC-E2 batchTo compare the effects on all other metabolic parameters…

Cost-effectiveness of treatment strategies for intermittent claudication

To evaluate the cost-effectiveness, from the perspectives of the health care system and of society at large, of supervised exercise compared to endovascular revascularization plus supervised exercise as first-line treatment of IC.

A pilot randomized controlled trial comparing the effect of a percutaneous and lipofilling technique in patients with a secondary Dupuytren*s contracture with standard fasciectomy surgery on convalenscence, contracture correction and recurrence rate.

To compare treatment of secondary Dupuytren*s contracture by standard limited (dermo)fasciectomy and by the modified percutaneous release combined with fat grafting. We focus specifically on return to function and if applicable to return to work (…

Influence of hyperglycaemia and sustained hypoxia on the hypoxic ventilatory response and the hypoxic pulmonary vasoconstriction.

In this study we want to investigate the effects of sustained hyperglycaemia and hypoxia on the hypoxic pulmonary vasoconstriction and hypoxic ventilatory response

A Clinical Safety and Efficacy Comparison of NEVANAC® 0.1% to Vehicle
Following Cataract Surgery in Diabetic Retinopathy Patients

Demonstrate superiority of NEVANAC® (nepafenac ophthalmic suspension) 0.1% relative to nepafenac vehicle based on the percentage of diabetic retinopathy patients who develop macular edema (defined as >=30% increase from pre-operative baseline…