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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…

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.

Treatment in patients with recurrent infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response.

The primary objective of the study is to compare the efficacy of intravenous immunoglobulin product with the efficacy of antibiotic treatment in patients with recurrent respiratory infections and IgG-subclass deficiency and/or selective anti-…

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…

Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Athritis: Safety and efficacy of vaccination with live attenuated Measles, Mumps, Rubella vaccine

The primary goal of the current study is to study the safety of and serological response to the MMR booster vaccination in JIA patients. Based on a retrospective analysis we hypothesize that MMR vaccination does not aggravate JIA disease and that…

Induction and waning of specific immune mechanisms against Bordetella Pertussis after infection.

I. Evaluation of the nature and maintenance of specific cellular immune mechanisms after infection with Bordetella pertussis in different age groups, to identify critical parameters for pertussis re-emergenceII. To relate individual patient*s…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With a History of Atherosclerotic Disease: Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2*P - TIMI 50)

Objectives:The following objectives are designed to address the effects of SCH 530348 when administered orally in addition to the standard of care for a minimum of 1 year in subjects with documented atherosclerotic disease.Primary Objective: The…

Evaluation of a newly developed spineboard in anaesthetized patients.

We want to study whether there is a difference with respect to the pressure exerted onto the body when using a normal spineboard and a newly developed spineboard, related to the level of consciousness of the volunteer. Also the experienced comfort…

Evaluating the effectiveness of an in-home self-management intervention to prevent psychological distress in frail older people living in the community

In the light of the aforementioned the current study has three objectives: 1) to study the effectiveness of an in-home self-management intervention to reduce fear of falling, avoidance behavior, catastrophizing about falls in order to prevent…

Grip op je dip online (Master your mood online): development and effectiveness

The aim of the project is to further develop and study the effectiveness of the Internet groupcourse Gripop Je Dip Online for young people (16-25 years) with depressive symptoms.Development objective:The eight-session groupcourse will be adapted…

A Phase 3 Randomized, Double-blind, Parallel-group, Multi-center Study of the Safety
and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill
Medical Subjects During and Following Hospitalization

To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total venous thromboembolism (VTE) and VTE-related death compared to standard, subcutaneous administration of enoxaparin 40 mg QD for a recommended…

A multi-center, randomized, controlled trial with programmed introduction of Sirolimus-based, Calcineurin inhibitor free immunosuppression in recipients of non-heart-beating donor kidney grafts.

To investigate the safety and efficacy of a programmed introduction of a sirolimus based calcineurin inhibitor free maintenance immunosuppressive regime three months after renal transplantation in recipients of a non-heart-beating donor kidney graft…

A randomized double-blind study of N-Acetylcysteine vs. placebo to Prevent Neurotoxicity induced by Platinum containing chemotherapy in patients treated for (Non)Small Cell Lung Cancer and Malignant Mesothelioma.

The primary objective is to establish the neuroprotective efficacy of NAC against cisplatin-induced neurotoxicity. Mainly the sensory neuronal guidance will be assessed before and after treatment with cisplatin in a group of patients receiving NAC…

On-line: Web-based Cognitive Behavioural Therapy (CBT) for Diabetic Adults with Minor to Moderately Severe Depression. A Randomised Controlled Trial.

This study aims to test the effectiveness and appreciation of a web-based cognitive behavioural therapy (CBT) program for adult diabetic persons with minor to moderately severe depression in a randomized controlled trial.

Effects of a high-fat and a low-fat diet on early biomarkers of metabolic stress in blood and gene expression in the small intestine of healthy subjects

The objective of this study is to compare in healthy subjects the effects of a HF diet (40 En% fat) with those of a LF diet (20 En% fat) on early biomarkers and parameters of metabolic stress in blood and on expression of genes in the small…

Prevention of neutrophil induced extracellular matrix damage following skin exposure to solar simulating radiation (SSR)

To investigate the effect of a sunscreen, a topical antioxidant and a topical corticosteroid on erythema, infiltrating neutrophils and oxidative stress following exposure of the skin to SSR.

Analyses of pathogen and host determinants in hospitalized patients with a laboratory confirmed Staphylococcus aureus infection: The PATHOS Study

Objective: to study host and pathogen determinants of S. aureus infection to identify a putative antigen as target for the development of a prophylactic vaccine against S. aureus.

Protocol CKI-301 KW-3902IV in the treatment of subjects with acute heart failure syndrome
A multicenter, randomized, double-blind, placebo-controlled study of the effects of KW-3902 injectable emulsion on heart failure signs and symptoms and renal function in subjects with acute heart failure syndrome and renal impairment who are hospitalized for volume overload and require intravenous diuretic therapy

To evaluate the effect of KW-3902IV in addition to IV loop diuretic therapy on heart failure signs and symptoms, persistent renal dysfunction, morbidity and mortality, and safety in subjects hospitalized with acute heart failure syndrome, volume…

Immune effects of acidic and neutral oligosaccharides in the nutrition of preterm infants.

Investigate the effect of acidic and neutral oligosaccharides supplemented enteral nutrition on infectious morbidity, feeding tolerance and short-term outcome in VLBW infants. Furthermore, an attempt is made to elucidate the role of acidic and…

Cefazolin, 1 gram fits all?

Objective: 1) to assess whether adequate serum and interstitial fluid levels of cefazolin are reached during surgery in obese and non-obese patients, 2) to develop a population pharmacokinetic model for cefazolin which allows the characterization of…