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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…

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.

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?

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.

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…

The efficacy of radioguided occult lesion localisation (ROLL) versus wire guided lesion localisation (WGL) in breast conserving surgery for non palpable breast cancer: a randomised controlled trial

To evaluate the efficacy of ROLL versus WGL in breast conserving surgery for non-palpable breast cancer.

Timing of PEG tube placement in patients with amyotrophic lateral sclerosis: soon or later?

Early PEG placement in ALS patients with dysphagia is associated with longer survival, better nutritional and functional status, and better quality of life

Reducing bilirubin induced neurological dysfunction in preterm infants:
additional use of the bilirubin:albumin ratio in the treatment of hyperbilirubinemia.

Neonatal jaundice due to unconjugated hyperbilirubinemia occurs in almost all preterm infants and is potentially neurotoxic. The current treatment modalities (phototherapy and exchange transfusion) are based on total serum bilirubin (TSB) levels,…

A randomized multicenter study of carboplatin-gemcitabine versus carboplatin-paclitaxel in elderly patients with non-small cell lung cancer with emphasis on geriatric assessment and quality of life:
The NVALT-3 study.

Gemcitabine-carboplatin is better tolerable than paclitaxel-carboplatin in elderly patients having advanced NSCLC as assessed with quality of life questionnairs.

CEMENTED VERSUS NON CEMENTED HEMIARTHROPLASTY OF THE HIP AS A TREATMENT FOR A DISPLACED FEMORAL NECK FRACTURE; A RANDOMISED TRIAL

Objective: The main objectives of this study are technical and functional outcome of the hemiarthroplasty

COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis.

Are there differences is efficacy, side effects, tolerance en costs in patients with early RA in treatment with COBRA-light compared with COBRA according to BeSt?

Treatment in the Rotterdam Early Arthritis CoHort

5. Study objective(s) and hypothesis:The aim of this study is to assess the value of early, intensive and efficient treatment of patients with recent acquired arthritis, in preventing progression into destructive RA

High-dose versus standard-dose weight-based ribavirin in combination with peginterferon alfa-2a for patients infected with hepatitis C virus genotype 1 or 4

To investigate if high-dose ribavirin in combination with peginterferon alfa-2a can improve outcome in treatment naïve hepatitis C patients with genotype 1 or 4 and a high viral load (>400.000 IU/ml).

A randomized, double-blind placebo-controlled, multicenter phase III study in patients with advanced carcinoid tumor receiving Sandostatin LAR and RAD001 10 mg/Day or Sandostatin LAR and Placebo

To determine whether treatment with RAD001 10 mg/d plus Sandostatin LAR® prolongs the progression free survival (PFS) compared to treatment with Sandostatin LAR® alone in patients with advanced carcinoid tumor.