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The analgesic efficacy of perioperative delta-9-THC (Namisol) in patients undergoing major abdominal surgery: a randomized, double blinded, placebo-controlled, parallel design

The primary aim of this study is to investigate the analgesic effect of perioperatively administered Namisol® to reduce postsurgical pain on the day of surgery and in the first five days after major abdominal surgery. A secondary aim is to…

Autologous BM derived MSCs in combination with everolimus to preserve renal structure and function in renal recipients

A 6-month study of efficacy and safety comparing concentration-controlled Certican® with MSCs to Certican® with standard tacrolimus in renal transplant recipients

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.

Protein supplementation after biliopancreatic diversion surgery

Correcting or preventing deficiencies of protein, by means of a protein supplement after a biliopancreatic diversion.

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…

Efficacy and safety of Haemocomplettan® P in patients experiencing microvascular bleeding while undergoing elective complex cardiac surgery

To determine whether fibrinogen concentrate infusion reduces perioperative blood loss and transfusion in patient experiencing clinically relevant microvascular bleeding during elective complex cardiac surgery and to determine whether its use is safe…

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…

In vivo induction of heme oxygenase-1 (HO-1) in the metabolic syndrome (MetS).
Influence of heme arginate (Normosang) infusion on heme oxygenase-1 activity, endothelial dysfunction, insulin resistance and adipose tissue inflammation related to the metabolic syndrome

Our main objective is to determine the effect of HO-1 induction by heme arginate infusion on insulin resistance and endothelial dysfunction related to MetS. Secondary objectives are to determine the effect on adipose tissue, adiponectin plasma level…

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…

The effect of helium on the immune system ex vivo

The aim of this study is to evaluate whether a 30-minute episode of helium breathing in humans affects the ability of the immune system to respond to ex vivo stimulation in whole blood taken from healthy volunteers.

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…

The effect of high dose cholecalciferol orally on serum of vitamin D in elderly with osteoarthritis of the hip

A pilot study the effect of high dose oral cholecalciferol suppletion on serum 25-OHD in elderly with osteoarthritis of the hip.

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 with these agents on ACF number, size and rate of dysplasia. 2) Gain mechanistic insight into the chemopreventive properties of 5-ASA and UDCA by…

Organ protection by noble gases * A clinical study to investigate Helium induced Pre- and Postconditioning in patients undergoing coronary artery bypass surgery.

The aim of this clinical study is to investigate whether the non-anaesthetic noble gas helium induces preconditioning (PreC) and postconditioning (PostC) in patients undergoing coronary artery bypass graft (CABG) surgery