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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 1, placebo-controlled, single ascending-dose study to assess the safety, tolerability and pharmacokinetics of OTL-038 injection in healthy volunteers

Primary objective:To assess the safety, tolerability and pharmacokinetics of a single IV dosages of OTL-038. Selected doses of OTL-038 will be studied in the absence and presence of prophylactic treatment with the antihistamine clemastine to be…

Evaluation of Sorafenib in combination with local micro-therapy guided by Gd-EOB-DTPA enhanced MRI in patients with inoperable hepatocellular carcinoma

Treatment strategy in early HCC aims at the local removal of the tumor and represents a potentially curative treatment option (resection, liver transplantation, PEI, RFA, BT). Patients in intermediate and advanced stage of HCC receive treatment with…

Randomized, double-blind, placebo-controlled, three way crossover, double dummy, single centre study evaluating the effect of haloperidol 2 mg and lorazepam 1 mg on posturography and underlying systems involved in standing balance in 12 healthy elderly subjects.

• To assess the effect of lorazepam compared to placebo on stability (Body Sway) in relation to stabilizing subsystems (BalRoom) in healthy elderly.• To assess the effect of haloperidol compared to placebo on stability (Body Sway) in relation to…

Effect of Gelofusine on 111In-DTPA-AHX-Lys40-Exendin 4 uptake in the kidney

Primary Objective: The primary objective is to determine whether the administration of Gelofusine will reduce the kidney uptake of 111In-labeled exendin in humans by enhancing the excretion of 111In-labeled exendin. These highly relevant data can…

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF LAMPALIZUMAB ADMINISTERED INTRAVITREALLY TO PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION

EFFICACY OBJECTIVESThe primary efficacy objective of this study is to evaluate the efficacy of intravitreal injections of 10 mg lampalizumab administered Q4W or Q6W in CFI profile biomarker positive and CFI profile biomarker-negative patients…

The safety and efficacy of Methylene Blue MMX® modified release tablets administered to subjects undergoing screening or surveillance colonoscopy.

Evaluation of the histologically proven adenoma or carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets. The lack of mucosal contrast,…

Putting resistance under the microscope

Main objectiveLorazepam is frequently used as an anaesthesiological premedication before surgery in order to reduce patients resistance. Does lorazepam also improve the quality of recovery in patients scheduled for day-case-surgery?Secondary…

A prospective cohort study to investigate the use of αvβ3-integrin scintigraphic imaging with 99mTc-NC100692 injection as a surrogate endpoint for therapeutic interventions in patients with myocardial infarction.

To investigate whether the extent of myocardial αvβ3 expression visualized by imaging with 99mTc -NC100692 Injection can be used as a surrogate endpoint for the outcome of therapeutic interventions, using standard and novel treatments (ACE-I vs. ACE…

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 ASPECT-2 Trial: A Phase 3, Randomized, Double-Blind Trial of Apadenoson for the Detection of Myocardial Perfusion Defects Using Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)

Primary:* To demonstrate non-inferiority between the level of agreement in diagnosis (i.e. patient classification of normal, mild/moderate or severe ischemic disease based on the number of reversible perfusion segments) between sequential adenosine…

A randomized double-blind placebo controlled trial to evaluate the value of a single bolus intravenous alfentanil in CT-colonography

Primary Objective: To evaluate whether a single intravenous alfentanil bolus (7.5 mcg/kg) has a clinically significant analgesic effect in clinical patients who undergo an elective CT-colonography compared to placebo. We have defined a clinically…

The effect of N-acetylcysteine and ascorbic acid on pulmonary arterial pressure and ventilation during normoxia, hypoxia and hyperoxia and total oxidant capacity.

In this study we will therefore investigate the influence of hypoxia and anti oxidants on HVR and HPV.

Oxytocin addition to cognitive behavioural therapy in PTSD

The main objective of this study is to assess the efficiency of oxytocin compared to placebo as an addition to the exposure sessions in the treatment of PTSD. We hypothesize that adding oxytocin to exposure in TF-CBT produces acute changes in…

Monosodium glutamate as a potential trigger for atrial fibrillation

To demonstrate the arrhythmogenic action of MSG in a single blinded placebo controlled test on these patients with reported MSG induced AF and to investigate the possibility of MSG as a potential trigger for AF.

A randomised, double-blind, placebo-controlled, parallel group, single centre study investigating the brain processing of visual stimuli in pre-menopausal women with generalized acquired hypoactive sexual desire disorder after 8 weeks of flibanserin (100 mg) treatment.

Change from baseline in regional cerebral blood flow in response to various visual stimuli ascertained by Positron Emission Tomography scan after 8 weeks of flibanserin 100 mg treatment.

Effects of postprandial hyperglycemia on aortic elasticity in impaired glucose tolerance and diabetes mellitus type 2

We aim to study the short-term effects of postprandial hyperglycemia in patients with impaired fasting glucose and in patients with T2DM on aortic stiffness as measured by PWV. Secondly, we study the effects of postprandial hyperglycemia on the…

UPFRONT - Prospective cohort study on early identification and treatment of adaptive deficits in mild to moderate traumatic brain injury - the impact of frontal network dysfunction for longterm outcome.

Objectives of the study: Project 1 - To assess early adaptive deficits in a multicentre cohort of mild to moderate TBI patients and their relation to outcome. Project 2 - Early intervention study of Cognitive Behavioural Therapy (CBT) to assess…

The effects of interferon-gamma on sepsis-induced immunoparalysis, a randomised double-blind placebo-controlled pilot (Phase IIIb) study

The primary aim of this pilot-study is to assess safety and the effects on immune function in patients with septic shock of adjunctive therapy with IFN-gamma, in a placebo-controlled manner. The data obtained will allow us to do a powercalculation…

The development of a thirst provocation test using the AVP receptor antagonist Tolvaptan for quantification of thirst sensation in various patient groups (obese patients with and without a history of bariatric surgery, patients with congestive heart failure and patients with cranial diabetes insipidus as compared to healthy controls) and genotyping of the AVP receptor 2.

We aim to investigate thirst in the above mentioned patient groups, applying a Visual Analogue Scale (VAS) and, where ethically acceptable, a new thirst provocation test which we will develop in a group of healthy probands. Using these tools, we aim…