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Stenting of symptomatic vertebral artery stenosis. A randomised safety and feasibility study

The primary aim of the proposed study is to assess whether stenting for symptomatic vertebral artery stenosis >= 50% is feasible and safe. A secondary aim is to assess the rate of new vascular events in the territory of the vertebrobasilar…

Local Infiltration Anaesthesia in Total Hip Arthroplasty by Anterior Supine Intermuscular Approach

Determining the outcome of reversed and antegrade LIA in THA with ASI by analysing postoperative pain with the 100 mm Visual Analogue Scale (NRS), length of hospital stay, the amount of postoperative consumption of opioid pain medication as well as…

Pilot study of everolimus in the treatment of advanced malignancies in patients with Peutz-Jeghers syndrome

To determine the efficacy (as measured by objective tumor response) of single agent everolimus in the treatment of advanced malignancies or high risk polyps of patients known with PJS .

Prevention of the progression of very early symptoms into ankylosing spondylitis

The general aim of this project is the primary prevention of the development of AS in patients with IBP, additional (SpA) features and inflammation on MRI of the SI joint and/or spine (but still no sacroiliitis on X-ray) by giving them, a short…

Urethral suspension using vas deferens for prevention of urine incontinence after robot-assisted laparoscopic prostatectomy (RALP)

Improve postoperative urine continence after prostatectomy for prostate cancer.

A Randomized, Double - Masked, Placebo - Controlled Study of PRM - 151 in the Prevention of Postoperative Scarring in Glaucoma Patients Following Primary Trabeculectomy.

Primary: To assess the effects of PRM-151 compared to placebo on the success of trabeculectomy by reducing post-surgical scarring in glaucoma patients who have undergone primary trabeculectomy, evaluated at day 120.Secondary: To assess the safety…

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.

Local infiltration anesthesia in total knee arthroplasty

Optimizing the amount of ropivacain and gabapentin, used for local infiltration (LIA) during TKA procedures by measuring the outcomes of pain (by using the 100 mm Visual Analogue Scale (VAS)), adverse effects, length of hospital stay, cumulative…

Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:
A Double-blind, Randomized Placebo-controlled Pilot Study

1) Study the chemopreventive potential of 5-ASA and UDCA in UC by evaluating the effect of treatment on ACF number, size and rate of dysplasia, relative to the placebo group. 2) Gain mechanistic insight into the chemopreventive properties of 5-ASA…

Metabolic modulation with metformin to reduce heart failure after acute myocardial infarction: Glycometabolic Intervention as adjunct to Primary percutaneous coronary intervention in ST elevation myocardial infarction (GIPS-III)

To evaluate the efficacy of metformin 500mg 2dd1 treatment compared with placebo 2dd1 in adjunction to optimal reperfusion therapy for acute MI on left ventricular ejection fraction at 4 months.

Improving primary care for relatives bereaved by suicide

1 to describe the long term effects of FGT and mutual support among first-degree relatives and spouses of suicide victims.2 inventarisation of help seeking behaviour of first-degree relatives and spouses of suicide victims during the first year…

EMR 200136-532: A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®

Primary objective: To assess the efficacy of Vigantol oil versus placebo as add-on therapy in subjects with relapsing-RemittingMultiple sclerosis receiving treatment with Rebif.Secondary objective:To assess changes on clinical parametersto assess…

Efficacy and safety of forced diuresis and guided fluid replacement
therapy on contrast media induced nephropathy; a feasibility study

2.1 Primary Objective: To evaluate the feasibility of RenalGuard for diuresis-guided fluid replacement therapy (ability to match in and output) (time to desired diuresis>200ml/hour) To evaluate the safety of forced diuresis and fluid…

A randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination with Aspirin Alone or with Aspirin and a Thienopyridine in Subjects with Acute Coronary Syndromes

There are two phases in this trial with 2 objectives:In phase I of the trial it will be assessed which dose of rivaroxaban is the most safe and effective (most optimal benefit:risk profile). In phase II this dose will be further investigated to…

LIMIT: Lowering the Incidence of vascular complications with Metformin in patients with Impaired glucose tolerance and a recent TIA or minor ischemic stroke: a phase 2, randomized, controlled trial

To examine the safety, tolerability, and effect on glucose metabolism of metformin treatment in non-diabetic patients with TIA or minor ischemic stroke and impaired glucose tolerance.

Efficacy of a health care program aimed at improving physical activity among older adults with an intellectual disability.

Objectives:1: Increasing the awareness of the older adults of the importance of physical activities2: Introducing the elderly to physical activities and familiarizing them with the fun of it3: Increasing physical activity, improving or maintaining…

The C-Seal study: Colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler: a phase II study.

The primary objective of this second phase study is to estimate the occurrence of anastomotic leakage when the C-seal is used.Secondary objectives are:* Feasibility of applying the C-seal, especially considering the improved attachement to the…

The adenosine receptor; a new pharmacological tool in the treatment of sepsis.

Does antagonism of the adenosine receptor by caffeine lead to an increased LPS-induced inflammatory reaction and an increase in (subclinical) tissuedamage?Does the C34T-polymorphism of the enzyme AMP-deaminase lead to a decreased inflammatory…

Effect of CAlcium on intestinal PErmeability and Diarrhea in Ulcerative Colitis

PRIMARY• To investigate whether calcium supplementation, in addition to standard induction therapy, decreases intestinal permeability (Chroom EDTA) in patients with active ulcerative colitis.• To observe whether calcium supplementation, in addition…

Investigation of posaconazole prophylaxis in children with chronic granulomatous disease (CGD): pharmacokinetics and tolerability (iPOD).

Primary: Dose finding for a twice daily regimen for PSZ as prophylactic treatment in children with CGD, based on the exposure to PSZ measured by PSZ trough levels.Secondary:To determine the tolerability of PSZ as prophylactic treatment in children…