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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

Prevention of breast cancer in high risk women by monitoring microrna expression in nipple aspirate fluid.

To establish biomarkers in nipple aspirate fluid, follow them in time and link them to breast cancer development at its earliest stage in women at high risk for breast cancer. Threshold values of biomarkers will be determined that point to a…

Oral function after oncological intervention, reconstruction and rehabilitation in the oral cavity

The aim of this study is to objectively and subjectively characterise different aspects of oral function for malignancy of the oral cavity.

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…

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…

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…

A study to determine the effect of post-infusion scalp cooling time in the high dose FEC-regimen

The primary aim of current study is to assess the effect of different cooling times on the efficacy of scalp cooling, thereby improving the results of scalp cooling in the high dose 5-Fluorouracil - Epirubicin - Cyclophosphamide (FEC) regimen. A…

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?

An open label, randomized phase III trial comparing 2.5 year duration of letrozole (Femara) treatment with 5 year duration in patients previously treated for endocrine sensitive early breast cancer

PrimaryTo investigate whether 5 years of extended adjuvant treatment with letrozole results in an improved DFS compared to 2.5 years treatment in patients with early breast cancer previously treated with endocrine agents for 5 yearsSecondaryTo…

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.

Prognostic factors in chronic rejection after human lungtransplantation

The primary objective is acquiring insights in the development of BOS in patients after human lung transplantation in an early phase of the disease which can be used to improve immunotherapeutic handling in order to prevent or delay the onset of BOS…

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…