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Phase III trial on Concurrent and Adjuvant Temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma. The CATNON Intergroup trial.

PRIMARY OBJECTIVESthe assessment if survival in grade III glioma without combined 1p/19q loss is improved by - daily temozolomide chemotherapy during radiotherapy - the administration of temozolomide after the end of radiotherapy SECONDARY…

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…

Transjugular Intrahepatic Porto-systemic Shunt (TIPS) with Gore-tex covered stent-graft versus endoscopic treatment for acute bleeding of esophageal varices.

The aim of this study is to compare the new (covered) TIPS stent with the standard treatment, local band ligation and/or sclerosing of the bleeding vessel under endoscopic guidance, in patients with acute bleeding of esophageal varices, with regard…

Primary Mesh Closure of Abdominal Midline Wounds
A double blind Randomized Controlled Trial

The objective of this study is to evaluate the usefulness of closing the abdomen with a prosthetic mesh after laparotomy for aortic aneurysm repair or in patients with a BMI larger than 27 in order to prevent an incisional hernia. The aim is to…

Comparative roentgen stereophotogrammetry analysis (RSA) between the conventional Mallory- Head stem in primary uncemented total hip replacement compared to two shorter variations

Objective: To perform a comparative assessment between the clinical, bone remodelling, and radiographic outcomes (as measured with RSA) of the conventional Mallory-Head stem compared two shorter versions of Mallory-Head stems in patients undergoing…

Primary Baerveldt glaucoma implant versus trabeculectomy study.

Demonstrate that compared to trabeculectomy, at 12 months follow-up:- a Baerveldt implant is not inferior with respect to IOP and- a Baerveldt implant is superior with respect to failure.

START * Stimulating Targeted Antigenic Responses To NSCLC A multi-center phase III randomized, double-blind placebo-controlled study of the cancer vaccine Stimuvax® (L-BLP25 or BLP25 liposome vaccine) in non-small cell lung cancer (NSCLC) subjects with unresectable stage III disease

Primary objective:* To compare survival duration of all randomized subjects by treatment arm.Secondary objectives of this trial are to compare all randomized subjects by treatment arm for:* Time to symptom progression (TTSP) as measured by the Lung…

Primary stability of cemented vs uncemented stems in revision total knee arthroplasty measured with RSA: a randomised controlled trial.

Which technique, cementing or press-fit implanting, of the tibial and femoral stem of the Legion revision total knee prosthesis provides the most primary stability?

A multi-centre randomised double blind, placebo and active controlled parallel group study to investigate efficacy and safety of ONO-5334 in post menopausal women with osteopenia or osteoporosis.

The objective of this study is to investigate if use of ONO-5334 has a more positive effect on bone density and biochemical markers of bone turnover than Alendronate (a bisphosphonate) and placebo.

Adalimumab for the treatment of perianal fistulas in Crohnâ¤*s disease more effective alone or combined to ciprofloxacin (ADAFI study)

To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone.

Protocol CV185030: A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of Apixaban In Preventing Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation

Primary objective: To determine if apixaban is noninferior to warfarin (INR target range 2.0-3.0) in the combined endpoint of stroke (ischemic or hemorrhagic) and systemic embolism, in subjects with AF and at lease one additional risk factor for…

A randomised clinical trial comparing minimal invasive (MIS) total knee replacement (TKR) with conventional total knee replacement

Objective: Does minimal invasive total knee replacement has (at least) comparable or better results to conventional total knee replacement if looked at functional recovery, complications and pain.Amendement 1: measure the accuracy of the cementing…

A randomized European Study Comparing Endoluminal Stent grafting and best medical Therapy (BMT) to BMT Alone in the Traetment of Acute Uncomplicated Type B Aortic Dissection

Objective of the study: The primary objective of this study is to assess the efficacy See primary endpoints, section 7.1 of endoluminal stent grafting and BMT compared to BMT alone in the treatment of uncomplicated acute type B aortic dissections.

Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo. Having finished this proof-of-concept
study it is intended that patients will continuously be treated in an open label
extension on a voluntary basis.

The aim of this Phase II proof of concept study is to assess efficacy, haemodynamics and safety of Terguride vs. placebo in patients with pulmonary arterial hypertension (PAH). Having finished this proof-of-concept study it is intended that patients…

Protocol for the clinical evaluation of wounds after topical administration of OTR4120 to ulcers.

To validate that OTR4120 will improve the healing of chronic ulcers.

Life After Cardiac Arrest

1. To determine the level of cognitive, emotional and cardiorespiratory impairment, daily functioning, participation in society, quality of life and partner strain up to one year after the survival of a cardiac arrest.2. To determine prognostic…

Dexamethasone infusion in community-acquired pneumonia

Primary objective:1. Reduction of hospitality duration in patients with CAP treated with intravenous dexamethasone. Secondary objective:1. Reduction of the use of intravenous antibiotics in patients with CAP treated with intravenous dexamethasone.2…

Dutch Arthoscopy Association Rotator Cuff Study

The objective is to evaluate and compare the outcome of conventional open or arthroscopic rotator cuff surgery, by means of clinical scores and biomechanical studies (range of motion, scapulohumeral rhythm, muscle activation patterns).

A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-inferiority Study Comparing the Efficacy and Safety of Once Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation (39039039AFL3001)

The primary objective of this study is to demonstrate that the efficacy of rivaroxaban, a direct FXa inhibitor, is non-inferior to that of dose-adjusted warfarin for the prevention of thromboembolic events in subjects with non-valvular atrial…

Group training for Hepatitis C patients to improve quality of life

The objective of the study is to improve quality of life of patients with Hepatitis C, by teaching patients psychological skills that aid in coping with the consequences of the disease.