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Effectiveness and Cost-effectiveness of Transmural Collaborative care with Consultation Letter (TCCCL) and Duloxetine for major depressive disorder (MDD) and (sub)chronic pain in collaboration with primary care: A randomized placebo-controlled Multi-Centre trial. TCC:PAINDIP.

The objective of this study is to establish the (cost) effectiveness of transmural collaborative care including a Consultation Letter for the GP and duloxetine (TCCCL) versus Duloxetine in patients with depression that present themselves with (sub)…

A double-blind, randomized, mulicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 1.25 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis

The purpose of this study in patients with primary progressive multiple sclerosis (PPMS) is to evaluatewhether FTY720 is effective in delaying MS disability progression in the absence of relapsescompared to placebo. Furthermore, safety and…

The airway smooth muscle cell in asthma:
A genomics approach

To examine the difference in gene expression profiles of ASM in bronchial biopsy specimens between asthmatic patients, non-asthmatic allergic and non-asthmatic non-allergic controls.To associate the gene expression profiles with airway…

Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

BAY 63 2521 is a direct stimulator of the soluble Guanylate Cyclase (sGC) and is intended for the treatment of cardiovascular diseases, especially Pulmonary Hypertension (PH).To assess the efficacy and safety of oral BAY 63 2521 in the treatment of…

Maraviroc Immune Recovery Study (MIRS):
A multicentre, randomized, placebo-controlled, exploratory mechanistic study into the role of Maraviroc on immune recovery

The primary objective is to confirm the hypothesis that Maraviroc stimulates immune recovery; the ssecondary objective is to explore, by virologic and immunologic investigations, the underlying mechanisms of this hypothesis.

Double-blind, randomized, placebo-controlled, parallel group, multi-centre phase III clinical study on the efficacy and tolerability of mesalazine granules vs. placebo for the prevention of recurrence of diverticulitis

The objective of the study is to compare the efficacy and tolerability of mesalazine granules (3 g 5*ASA/d) vs. placebo for the prevention of recurrence of diverticulitis. Additionally, the safety and tolerability in the form of adverse events and…

A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension

Primary: To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 12) in subjects with PAH who are not currently receiving ERA, PDE-5…

The effect of a multispecies probiotic on hypersensitivity in IBS patients

The effect of a specially developed multispecies probiotic on visceral perception, as well as on general symptom scores and inflammatory and microbiological parameters will be studied in a pilot study of IBS patients with an increased visceral…

A Phase 1, Double Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 388626 Administered to Healthy Volunteers

To evaluate the safety and tolerability of a single subcutaneous (s.c.) injection of ISIS 388626 administered at four increasing dose levels (50, 100, 200, 400 mg) and to evaluate the safety and tolerability of multiple doses of ISIS 388626…

Sitagliptin prophylaxis for glucocorticoid-induced impairment of glucose metabolism and beta-cell function in males with the metabolic syndrome-X: a randomized, placebo controlled, double blind, 2x2 factorial designed intervention trial.

The objective of this study is to assess whether sitagliptin may prevent prednisolone-induced impairment of glucose metabolism and beta-cell function.

RAAS-blockade in type II diabetes: added effects of a low sodium diet and diuretics.

Determinination of the added effects of dietary sodium restriction or diuretic use to antihypertensive and antialbuminuric therapy.

Exploratory trial on intra-articular etanercept treatment in inflammatory arthritis

The primary objective is to determine if intra-articular etanercept therapy reduces the clinical signs and symptoms of inflammatory arthritis and improve outcome (beneficial effect). The secondary objective is to study safety and to analyse…

A Phase IIa, multi-centre, randomised, double-blind, placebo controlled, clinical study investigating the safety, tolerability and pharmacokinetics of two different infusion doses over 72 hours of a new regimen and new formulation of MCI-186 in subjects with acute ischemic stroke

STUDY OBJECTIVESPrimary objectiveTo assess the safety, tolerability and local tolerance of two different intravenous infusion doses over 72 hours of a new dosing regimen and a new formulation of MCI-186 in subjects with acute ischemic stroke.…

The influence of supplementary regional infiltration anesthesia with ropivacaine on postoperative pain, nausea and vomiting in patients undergoing mamma surgery under general anesthesia

To investigate that in mamma surgery, regional infiltration with ropivacaine 0,75% added to general anaesthesia causes less postoperative pain, nausea and vomiting compared to general anaesthesia alone.

Randomized, single-blind, placebo controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn*s disease.

The primary objective of the study is to evaluate the efficacy of intralesional administration of eASCs (CX-401) when added to standard surgical care and drainage for the treatment of complex perianal fistulas in patients with Crohn*s disease (CD).

Acute effects of growth hormone on cognitive functioning and related brain physiology in healthy subjects

We will evaluate the acute effects of GH on, and its relation with, cognition in healthy subjects. The present proposal focuses on the following questions:1. Does an acute rise of plasma GH levels have a (beneficial) effect on cognitive performance…

A double-blind, placebo-controlled, dose-escalation, parallel-group study to evaluate the efficacy and safety of E2007 (perampanel) given as adjunctive therapy in subjects with refractory partial seizures.

Primary Objective: The primary objective is to evaluate the efficacy of 2 doses ofperampanel (8 and 12 mg) in comparison to placebo given as an adjunctive therapy insubjects with refractory partial seizures.Secondary Objective: The secondary…

Insulin-induced microvascular dilatation during a physiological stimulus - Studies in hypertension and obesity.

1 : Will the intake of a liquid meal lead to insulin-induced microvascular dilatation in healthy subjects? 2: Does meal composition (high fat meal vs. high carb meal) play a role in the occurence of insulin-induced microvascular dilatation in…

Effects of N-3 fatty acids (DHA and EPA) on cognitive control and associated brain activity in ADHD: A double-blind placebo controlled study

The objective of the present study is to investigate whether a diet rich in n-3 fatty acids (DHA/EPA) can improve brain activation patterns assiociated with cognitive control in children with ADHD .

An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 versus Placebo in Subjects with Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer

To evaluate PFS with XL184 treatment as compared with placebo in subjects with unresectable, locally advanced, or metastatic MTC to see if the investigational drug XL184 is effective in delaying the growth of the tumor.