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The effect of vitamin D-supplementation on insulin sensitivity in non-western immigrants in the Netherlands

To assess whether supplemention of vitamin D3 (1200 IU/day) in vitamin-D deficient non-western immigrants at risk for type 2 diabetes mellitus can improve the insulin resistance and betacell function as well.

Prednisolone Rhinosinusitis Efficacy Trial (PRET) study

To assess the effects of a 7-day course of 30 mg prednisolone daily in addition to usual care (symptomatic) treatment in adults with RS.

Randomised, double-blind, placebo-controlled single ascending dose study investigating the safety, tolerability, pharmacokinetic and pharmacodynamic properties of the research medication in healthy young and elderly men, and open-label three-period crossover food interaction study of the research medication in healthy elderly men

- to examine the safety and tolerability of the research medication- to examine how the research medication is absorbed, broken down and excreted by the body.

Randomized double blind multi-centre study of the effects on low-dose pegvisomant treatment in acromegalic subjects in whom the IGF1 levels has been normalized by long-acting somatostatin analogues

Primary Study Objective:To assess the efficacy and safety of the co-administration of low-dose pegvisomant (40 mg, administered via subcutaneous injection given once a week) and long-acting somatostatin analogs (administered once monthly) on the…

Effect of high frequency transcranial magnetic stimulation on negative symptoms and cognitive functioning in schizophrenia: a combined treatment and neuroimaging study

Transcranial magnetic stimulation (TMS) is a non-invasive, save method to stimulate the cerebral cortex and thereby alter neuronal function. In TMS a coil, which delivers brief magnetic pulses is placed adjacent to the scalp. The magnetic field…

Neuro-cognitive effects of tyrosine supplementation in healthy older adults:
A fNIRS-EEG study

We aim to assess the effects of tyrosine supplementation on prefrontal brain activation, as measured by a combination of fNIRS and EEG, during response inhibition and working-memory performance in older adults. We will also assess whether…

Effectiveness of probiotics in the treatment of children with chronic abdominal pain and small intestinal bacterial overgrowth. A randomized placebo-controlled trial.

The aim of this study is to find a succesful treatment for chronic abdominal pain and small intestinal bacterial overgrowth in children and at the same time improve the quality of life of these children. A second aim is to reduce the hospital visits…

Treatment of severe acute GVHD after allogeneic hematopoietic stem cell transplantation with steroids versus MSC and steroids.
A prospective double-blind placebo-controlled randomized phase III trial

To improve the response rate to treatment of severe acute GVHD (grade II-IV with gut involvement ) by adding infusion of Mesenchymal Stroma Cells to standard high dose prednisolone.

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation

2.1 Primary Objectives• Evaluate the safety and tolerability of 2 fixed doses of FRM-0334 (300 and 500 mg daily in 2 sequential periods) over 28 days in subjects with prodromal to moderate FTD-GRN• Assess the PD effects of FRM-0334 on the change…

A double blind, randomized, placebo controlled, cross-over study to validate the predictive power of the demarcation formula for Lybrido and Lybridos efficacy in women with female sexual interest/arousal disorder, in the domestic situation.

Primary Objective• To validate the existing demarcation formula (consisting of psychometric and biological markers) which predicts the sensitivity to Lybrido or Lybridos in women with female sexual interest/arousal disorder (FSIAD with or without…

A Phase 2b, double-blind, randomized, placebo-controlled study of RVT-101 in subjects with dementia with Lewy bodies (DLB).

Primary• To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician*s Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment• To assess the effects of RVT-101 versus…

A randomized, double-blind, placebo-controlled, parallel-group study to investigate the safety, tolerability, and pharmacodynamics of JNJ-54175446 in subjects with major depressive disorder.

Primary objective:-To investigate the safety and tolerability of JNJ-54175446 in subjects with major depressive disorder.Secondary objectives:-Investigate the effect of JNJ-54175446 versus placebo on total sleep deprivation-induced changes in…

A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION

Objectives: For patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) enrolled in this study, the objectives are as follows:Primary: -To assess the efficacy of bardoxolone methyl relative to placebo.Secondary…

Effects of BCG vaccination on immunological characteristics of hematopoetic stem cells: an explorative study

To examine the effect of BCG vaccination on the composition and function of the bone marrow.

Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and
Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or
Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

The primary objective of the study is to assess whether the addition of oral veliparib to carboplatin and paclitaxel will improve overall survival (OS) in current smokers when compared to the addition of placebo to carboplatin and paclitaxel, in…

A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of LTI-291 in Healthy Middle-Aged to Elderly Subjects

- To evaluate the safety and tolerability of four oral dose levels of LTI-291 following multiple administrations in healthy middle-aged to elderly subjects. - To characterize the plasma and cerebrospinal fluid (CSF) pharmacokinetics (PK) of LTI-291…

Randomized, double-blind, double-dummy, placebo-controlled, four-way crossover single dose
study to determine the test-retest reliability of, and the effect of oral valproic acid, levetiracetam and
lorazepam on, cortical excitability measurements in healthy volunteers as measured by TMS-EEG and TMS-EMG.

Primary Objective- To investigate the ability of TMS-EEG measures to detect effects on cortical excitability of valproic acid, levetiracetam and lorazepam in healthy subjects- To investigate the ability of TMS-EMG measures to detect effects on…

A phase 2, double-blind, randomized, placebo-controlled pharmacokinetic trial in two parallel groups to investigate possible drug- drug interactions between stiripentol or valproate and GWP42003-P in patients with epilepsy.

Primary Objective: To determine whether GWP42003-P affects the pharmacokinetic (PK) profile of stiripentol (STP) or valproate (VPA).Secondary Objective: To assess the safety and tolerability of GWP42003-P in the presence of STP or VPA.To assess…

A First-in-Human Randomized, Placebo-controlled, Double-blind, Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of LTI-291 in Healthy Subjects

- To evaluate the safety and tolerability of four different single oral doses of LTI-291 in healthy subjects.- To characterize the plasma pharmacokinetics (PK) of LTI-291 following single oral dosing in healthy subjects.- To evaluate the…

Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event
International, multi-centre, randomized, double-blind placebo-controlled phase II study.

Efficacy and safety trial with S 44819 after recent ischemic cerebral Event