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A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients with Locally Advanced or Metastatic Adrenocortical Carcinoma

The primary objective of this study is to determine the overall survival (OS) of single agent OSI-906 (Arm A) versus placebo (Arm B) in patients with adrenocortical carcinoma (ACC) who received at least 1 but no more than 2 prior drug regimens.

A randomized, double-blind, placebo controlled, parallel group, multi-centre, 2-week treatment study to evaluate the safety and efficacy of fluticasone furoate nasal spray (FFNS) 110 mcg, administered either once daily or twice daily, compared with placebo, as effective monotherapy in the treatment of uncomplicated acute rhinosinusitis (ARS) in adult and adolescent subjects 12 years of age and older.

The objective of this study is to evaluate the safety and efficacy of two doses of FFNS (110 mcg once daily and 110 mcg twice daily) compared to placebo as monotherapy in the treatment of adult and adolescent subjects 12 years of age and older with…

RAndomized comParison between the Stentys self-exPanding COronary Stent and a balloon-expandable stent In AcuTe MyocardIal InfarctiON

The primary objective is to assess the safety and operation of the Stentys coronary stent system in patients with acute myocardial infarction compared with a balloon-expanding stent. These are the effect and safety in the short term (the procedure…

A Microdose Study to Describe the Intravenous Pharmacokinetics of [14C]-GSK2239633 in Healthy Male Subjects.

Primary:To investigate the intravenous pharmacokinetics of [14C]-GSK2239633 in healthy male subjectsTo compare total radioactivity (drug-related material) in plasma relative to parent plasma concentrationTo determine total radioactivity (drug-…

Effects of levosimendan on diaphragm contractility in healthy subjects

The primary objective of this proof of principle study is to determine the effect of levosimendan on the strength and endurance of the diaphragm in healthy subjects. The secondary objective is to gain insight in the neural activation and efficiency…

Does local application of betamethasonvalerate 0.1% cream twice a day reduce the complaints of chronic chilblains?

Research question:Does thin application of betamethasonvaleraat cream 0,1% on perniones lesions twice a day reduce the symptoms of patients as determined in 1st. line health care, with at least 10 mm expressed on a visual analogue scale, together…

The effects of oral dipyridamole treatment on the innate immune response during human endotoxemia.

Primary objective: The primary objective of the study is to determine the effect of oral dipyridamole treatment on the innate immune response induced by a lipopolysaccharide (LPS) challenge. Various pro- and anti-inflammatory cytokines will be…

An Open-label, Randomized Phase 3 Study of the Efficacy and Tolerability of Linifanib (ABT-869) versus Sorafenib in Subjects with Advanced Hepatocellular Carcinoma (HCC)

The primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC. The…

A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS)

The purpose of this study is to determine if SAR153191 SC (subcutaneous) injection once a week or every other week is safe and effective compared to placebo (an inactive solution injection ) in reducing the recurrence and symptoms of Ankylosing…

A Randomized Phase 3 Study of Tasisulam Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle vs. Paclitaxel as Second-Line Treatment in Patients with Metastatic Melanoma

The primary objective of this study is to compare the overall survival (OS) of patients whohave received one prior regimen of dacarbazine or temozolomide-based chemotherapy for metastaticmelanoma when treated with either tasisulam or paclitaxel.The…

A phase I, open-label, randomized, three-way cross-over study to determine the relative bioavailability of an oral capsule formulation, given both in the fasted state and after a high fat meal, compared to an oral suspension of PSN821 in healthy male volunteers.

Primary:- to determine the relative bioavailability of a solid formulation (capsule) of PSN821 compared with an oral suspension of the drug.Secondary :- to determine the effect of food on to determine the effect of a high fat meal or light breakfast…

A first-in-human single-dose escalation study of the safety, pharmacokinetics and pharmacodynamics of the test drug including brain Serotonin Receptor Transporter (SERT) occupancy by Positron Emission Tomography (PET).

Part A: to investigate the safety and tolerability of the drug after a single oral dose in healthy male volunteersPart B: to explore the relationship between dose/exposure of the drug and brain serotonin receptor transporter (SERT) occupancy after a…

A double blind, randomized, parallel, study to assess the effects of aliskiren/amlodipine and amlodipine monotherapy on ankle foot volume (AFV) in patients naïve to trial drugs with mild to moderate hypertension.

Primary objective:To assess and compare the effects of aliskiren/amlodipine and amlodipine on pedal edema after 4 weeks of treatment as measured by ankle foot volume (AFV) (water displacement method) in patients with mild to moderate hypertension.…

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATION STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF SINGLE AND MULTIPLE DOSES OF 2-IMINOBIOTINE (2-IB) IN HEALTHY MALE SUBJECTS

Primary objectives- to investigate the safety and tolerability of single and multiple doses of 2-IB pulse iv infusion in healthy male subjects - to determine the pharmacokinetics after single and multiple doses of 2-IB pulse iv infusion in healthy…

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 prospective, double-blind, placebo-controlled trial investigating the efficacy and safety of Org 25935 in relapse prevention in subjects with alcohol dependence

Primary objective- To assess the effects of Org 25935 on heavy drinking in subjects with alcohol dependence.Secondary objectives- assess the effects of Org 25935 on the amount of drinking- To assess the effects of Org 25935 on the first relapse to…

The level of physical activity and participation in society of adolescents with chronic musculoskeletal pain.

1. Is there a difference between the level of activities and participation among adolescents with chronic musculoskeletal pain as compared with the activity and participation level of adolescents not suffering from chronic pain?2. What is the impact…

DCE MRI in the follow-up of prostate cancer patients after radiotherapy; a matched case control stuy (Pilot)

To measure the differences of DCE MR images between patients with and without local recurrent prostate cancer in the follow up after primary treatment.

An open phase 1, dose-escalating, clinical trial on the safety of a new liposomal adjuvant system, CAF01, when given with the tuberculosis subunit vaccine Ag85B-ESAT-6 as two injections with two months interval to healthy adult volunteers.

Primary:The primary objective is to evaluate the safety profile of an adjuvated Tb subunit vaccine (CAF01) administered in 50 µg Ag85B-Esat-6 alone, 50 µg Ag85B-Esat-6 alone with three escalating CAF01 dose levels, to four groups of healthy…

Pilot Study: are human intestinal biopsies usefull as in vitro model for the small intestine

Human intestinal biopsies will be used to further develop an in vitro intestinal model. This model will the be used for future research to study the effect of nutreints and drugs on intestinal function. The human biopsies will be compared with…