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Prospective, randomized, pharmacological intervention study; evaluating the effect of the angiotensin II-receptor (AT1) blocker candesartan versus placebo in prevention of trastuzumab-associated cardiotoxicity in patients with primary breast cancer treated with trastuzumab

Primary objectives:1) To determine whether concurrent ATII-antagonist treatment can prevent trastuzumab-related cardiotoxicity, defined as a decline in LVEF of more than 15% or a decrease to an absolute value <45%Secondary objectives:1) To…

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 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.

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…

Organ protection by noble gases * Helium induced Early and Late Preconditioning (HELP) in human endothelium

The aim of this clinical study is to investigate whether the non-anaesthetic noble gas helium induces EPC and LPC of human endothelium in vivo.

The effect of the α7nACh receptor agonist GTS-21 on inflammation and end-organ dysfunction during human endotoxemia

to study the effect of pre-treatment with the specific a7nAChR agonist GTS-21 on cytokine production and the effects on the subsequent subclinical organ dysfunction in the human endotoxemia model. to measure the effect of LPS administration in the…

The development and examination of an intervention aimed at youths who have to be treated at the emergency department of a hospital as a result of excessive alcohol use.

Aim of the study is to develop and test a brief intervention for adolescents who have to be treated in the emergency department of a hospital due to excessive alcohol use.

Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism.

For the Einstein-DVT evaluation. The primary efficacy objective is to evaluate whether rivaroxaban is at least as effective as enoxaparin/VKA in the treatment of patients with acute symptomatic deep-vein thrombosis (DVT) without symptomatic…

The effect of an exercise program on insulin sensitivity and plasma glucose levels in women at risk for gestational diabetes mellitus.

The overall aim of the study: To assess whether an exercise program can improve insulin sensitivity and fasting plasma glucose levels of women at high risk for gestational diabetes, assuming that this will normalise their risk of gestational…

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 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…

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…

Comparing the effects of a new method to prevent constipation according to the usual method to prevent and to treat constipation bij patients lying in the hospital with a neurological disease.

The effectivity of a standard preventing constipation and treatment list, designed by the hospital nutritionteam, will show that neurological patients during their stay in the hospital develop less constipation.

Sexuality and the self: studying gender-, social- and cultural differences in sexual self-concept as an explanation for unplanned pregnancies and abortion in teenagers

Aim of the research is the development and evaluation of an intervention to promote the sexual and reproductive health of adolescents who differ in cultural background. Fundamental idea is that sex education is more effective if the information is…

Does Misoprostol facilitate insertion of an Intra Uterine Device (IUD), both copper-containing as well as levonorgestrel-releasing, among nulli- and multipara?

To investigate whether Misoprostol (compared to placebo) will diminish the amount of insertion failures. To investigate whether Misoprostol (compared to placebo) will diminish the amount of insertion related complications (eg. syncope, perforation…

Blood glucose homeostasis in type 2 diabetes: the effects of sacharose

The aim of this study is to investigate the glycemic effects of the consumption of soft drinks, under fully standardized nutritional conditions, in obese type 2 diabetes patients and non-obese and obese normoglycemic control subjects.

Prospective cohort study on the effect of surgical treatment of obstructive sleep apnea syndrome on blood pressure (and other cardiovascular risk factors).

In The Netherlands 2% of women and 4% of men suffer from Obstructive Sleep Apnea Syndrome (OSAS). NCPAP, the gold standard therapy for moderate to severe OSAS has been shown to reduce blood pressure in OSAS. NCPAP therapy is however hampered by…

RANDOMIZED CONTROLLED TRIAL TO REDUCE FALLS AND FEAR OF FALLING IN FRAIL ELDERLY

-To test the efficacy and determine the costs of a multifaceted intervention program to reduce falls incidence rate and fear of falling, and thereby improve mental wellbeing in community dwelling frail elders, with high level of comorbidity and…

Participatory interventions for return-to-work for temporary agency workers and unemployed workers sicklisted due to musculoskeletal disorders.
A randomised controlled trial and cost-effectiveness evaluation.

For this study the aim was first to adjust the parcipatory return-to-work method for employees with nonspecific LBP to the working methods and procedures of the national organisation, responsible for counseling, disability management and activating…