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A Six Month Phase II/III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Telcagepant (MK-0974) for Prevention of Menstrually Related Migraine in Female Patients with Episodic Migraine

• Test the safety of the research drug, telcagepant (MK-0974)• Test the safety of the research study drug telcagepant (MK-0974) in the prevention of menstrually related migraines. • Compare the effectiveness of the research study drug telcagepant (…

Thrombolysis Or Anticoagulation for Cerebral venous Thrombosis

The objective of this study is to determine the clinical efficacy of endovascular thrombolytic treatment (ET) as compared to standard treatment (any therapeutic heparin regimen) in patients with proven cerebral venous sinus thrombosis and a high…

An open, multicentre, randomised, inter-individual comparative, prospective clinical trial with MD-3511356 versus standard sun protection measures in immunosuppressed outpatients after solid organ transplantations for the prevention of UV-induced infections and carcinogenic skin alterations

3. TRIAL OBJECTIVES AND PURPOSE3.1 Primary ObjectiveThe primary objective is the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immuno-suppressed…

Postprandial FGF-19 response after fat challenge in patients with cholestatic liver disease

Hypothetically, in patients with PBC or PSC the FGF-19 production or -response could be altered. The goal of this research is to study the FGF19 production after a standardized oral fat challenge and the effect of this FGF19 production on bile acid…

LEADER: Liraglutide Effect and Action in Diabetes Evaluation of cardiovascular outcome Results;A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events.

Primary objective:To assess the effect of treatment with liraglutide compared to placebo for at least 3.5 yearand up to 5 years on the incidence of cardiovascular events, as defined by the belowprimary and secondary endpoints, in adults with type 2…

The effect of isoflavone supplement intake on gene-expression in postmenopausal women

Primary objective: to determine the effect of intake of one dose of isoflavones, as compared to placebo, for eight weeks on gene-expression in Peripheral Blood Mononuclear Cells (PBMCs) in post-menopausal, equol-producing women.Secondary Objectives…

Dutch National Food Consumption Survey - Non-institutionalized Elderly 2010/2011

The food consumption survey aims to provide insight in the intake of energy, macro and micronutrients, and foodgroups by non-institutionalized elderly people (age 70 y and over) and the percentage of this population group that meets the nutritional…

A Kaletra ONCE daily Randomised Trial of the
pharmacokinetics, safety and efficacy of twice-daily
versus once-daily lopinavir/ritonavir tablets dosed by
weight as part of combination antiretroviral therapy in
HIV-1 infected children (PENTA 18).

Evaluating the current dosing guidelines in children taking the half-strength paediatric tablets will provide reassurance that the recommended lopinavir/ritonavir dose provides adequate drug exposure and maintains efficacy.This trial will evaluate…

The identification of causal factors for premature delivery in placenta and myometrium

To obtain a durable biobank of placenta, placental bed and myometrium, combined with a good clinical database. The tissue will be used to investigate differences in tissue specific expression between woman who have not gone into labour and deliver…

A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Elective Hepatic Surgery

The objective of this study is to evaluate the safety and hemostatic effectiveness of FP versus SoCtreatment in controlling parenchymal bleeding during hepatic surgery.

Two-Center, In-Patient, Randomized, Placebo and Active Comparator Evaluation of the Pharmacokinetics (PK) and Safety, Along with Initial Pharmacodynamic (PD) Efficacy of Three Dose Levels of TBS-2 Intranasal Gel Applied Twice-Daily (BID) for up to Three Days in Female Patients with Hypoactive Sexual Desire Disorder (HSDD) or Anorgasmia (ANOR).

This clinical trial is being performed to evaluate the PK profile of TBS-2 administered as single and multiple (BID) doses in patients with HSDD or ANOR. In addition, the study will evaluate the initial PD efficacy and safety of intranasal TBS-2 BID…

Palliation through physical training

This pilot study focuses mainly on the feasibility and safety of the study (inclusion, randomization, testing procedure, evaluation of the training).The main objective of the intended study is to investigate whether a 12-week, group wise supervised…

Postprandial insulin release and the impact on muscle perfusion

We hypothesize, that during an oral glucose tolerance test, the OPS arterial flow measured sublingual will be comparable within the same subject, but different between young, elderly and type 2 diabetic patients. Objective is to quantify differences…

An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers

Primary:To compare total radioactivity (drug-related material) in plasma relative to parent plasma GW642444 concentration following a single oral dose (200µg) of [14C]-GW642444 in healthy male subjects.To determine the rate and extent of excretion…

HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease

To determine the safety and efficacy of Dimebon in patients with mild to moderate Huntington Disease

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SEQUENTIAL DOSE ESCALATION STUDY OF THE SAFETY, TOLERABILITY, PHARMACODYNAMICS AND PHARMACOKINETICS OF SINGLE SUBCUTANEOUS DOSES OF HM11260C IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS

Primary:To evaluate the safety and tolerability profile of single escalating subcutaneous (sc) dose levels of HM11260C in adult patients with type 2 diabetes mellitusSecondary:To evaluate the dose response relationship of single escalating sc dose…

Validity of strength measurements with the KinCom and Biodex dynamometer in PPS patients

To investigate the validity the dynamometer the KinCom in comparison to the Biodex dynamometer.

Which muscles are critical for abnormal posture, balance and gait in patients with FSHD?

The primary aim of this study is to identify the muscles that are most critical to the abnormal standing posture, standing balance and gait in FSHD patients and to elucidate the most important mechanisms of falls. The ultimate goals are (1) to…

The effect of vinegar co-ingestion on postprandial glucose control in type 2 diabetes patients.

The main objective of this study is to assess the acute effect of co-ingested vinegar on postprandial plasma glucose levels in type 2 diabetes patients.

A 24-month, multi-center, open-label, randomized, controlled trial to investigate efficacy, safety and evolution of cardiovascular parameters in de novo renal transplant recipients after early calcineurin inhibitor to everolimus conversion (CRAD001A2429, ELEVATE study)

Primary objective: To demonstrate superior renal allograft function in de novo renal transplant recipients after early CNI to everolimus conversion assessed by Glomerular Filtration Rate (eGFR) estimated by the Modification of Diet in Renal Disease…