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Study of the relation between biomarker patterns and the incidence of recurrent coronary events during 1-year follow-up in patients who were hospitalised for an acute coronary syndrome; BIOMarker Study to identify the Acute risk of a Coronary Syndrome (BIOMArCS)

Describe the relation between patterns in biomarkers of vascular inflammation, plaque instability and hypercoagulability and the incidence of recurrent ACS

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…

The relationship between pain and cognitive functioning, of patients with neurodegenerative diseases such as Parkinson's disease, Multiple Sclerosis and Huntington's disease
Substudy: The relationship between pain, cognitive functioning, and motor activity in patients with multiple sclerosis

Various brain areas play a crucial role in both pain and cognition, supporting the existence of a close relationship between pain and cognition. Consequently, it is important to examine whether pain experience changes at the moment the patient shows…

7 Tesla MRI protocol development

To further optimize 7.0 Tesla MRI techniques and to develop new MRI techniques that will enable state-of-the-art clinical and cognitive research leading to improved patient care. Whereas some applications of 7.0 Tesla MRI already show improvements…

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…

A 4-Year Open-Label Extension (OLE) Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E2007 as an Adjunctive Therapy in Patients With Refractory Partial Seizures

To evaluate the safety of E2007 given as adjunctive, long-term treatment in patients with refractory partial onset seizures with or without secondary generalization that completed the E2007-A001-206 or the E2007-G000-208 studies (revised per…

Amendment on the CYPTAM documentation study: effect of CYP2D6 genotype on pharmacokinetics and clinical outcome in tamoxifen treated breast cancer patients:;(P07.234 CYPTAM study)
Validation and optimization of 13C-dextrometorphan breath test (DM-BT) for CYP2D6 phenotyping

-To optimize DM-BT by addition of multiple breath sampling and improve it for use in clinical practice-To create a population based pharmacokinetic model based on DM-BT predicting endoxifen serum levels-To identify ideal single or two time points…

Course in functioning and care needs in young onset dementia

The present study will examine how young-onset-dementia patients and their families can be supported in their home environment as long as possible and institutionalisation can be delayed. For this the functioning and care needs of young-onset-…

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…

Comparison of celite activated clotting time with kaolin activated clotting time during cardiac surgery.

We want to compare duplicate measurements of celite ACT and kaolin ACT in patients undergoing cardiac surgery. In addition we want to measure heparin use during surgery in patients monitored with celite ACT and with kaolin ACT.In addition,…

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…

The present proposal contains three separate research questions with a different background that both will be an extension of the Wheezing Illnesses Study Leidsche Rijn (WHISTLER).
Study 1: The relations between early childhood obesity and arterial disease.
Study 2: Low lung function in early childhood: nature or nurture?
Study 3: The relation between Diabetes type I during pregnancy and vascular characteristics in the offspring.

Study 1: The purpose of this study is to gain more insight in the characteristics that are related to vascular damage at a young age, and particularly to detect if obesity is related to vascular damage (and thus the risk of cardiovascular disease in…

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?

Brain-Computer Interface based on Cortical Electrodes

The present protocol addresses these issues, with a systematic approach where we first assess optimal settings for BCI, and then test the quality of BCI application in adequately sized groups of subjects. The whole project is aimed at obtaining a…

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…