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To compare the feasibility and safety of surface cooling to 34, 34.5, and 35*C, started within 4.5 hours after the onset of acute ischaemic stroke and maintained for 24 hours, in awake patients on a stroke unit.
To investigate the effect of cholic acid supplementation on the clinical and biochemical parameters of Zellweger spectrum disorder
The goal of this trial is to collect long-term observational data on the tolerability, safety and efficacy of dabigatran etexilate in a spectrum of patients receiving bileaflet mechanical heart valves. All patients that have completed study 1160.113…
Run-in phase I: To confirm the safety and tolerability of BIBF 1120 up to a dose level of 200 mg b.i.d added to a standard dose of cisplatin/gemcitabine in first line NSCLC patients with squamous cell histology. Pharmacokinetics of BIBF 1120 and…
The purpose of this study is to confirm/validate predicted dabigatran trough plasma levels gained after individual dose assignment based on simulations by means of PK data from the RE-LY trial. Based on this validation a final appropriate dosing…
To assess the impact of 7 daily subcutaneous gifts of GH on circulating Klotho levels in human sugjects with CKD stage III and healthy age-matched controls.
To assess the impact of six IV infusions of 3, 6, or 12 mg/kg of CER-001 or placebo, given at weekly intervals, on atherosclerotic plaque volume, as measured by coronary IVUS.
The main objective of this study is to investigate of the drug EMD 525797 is better then no treatment with subjects with metastasized asymptomatic or mild symptomatic mCRPC. The efficacy and safety of the drug EMD 525797 is evaluated.Primary…
Primary Objective: * Is CBM-I successful in changing the cognitive bias in patients with cluster-C personality disorders or personality disorder NOS?Secondary Objective(s): * Will patients following CBM-I show a significant reduction in symptoms and…
Primary objective:To show that concomitant use of telaprevir (1125 mg BID) does not lead to a relevant decrease (> 20%) in the paroxetine parameter AUC0-24h compared to paroxetine alone.Secondary objectives:To determine the ratio of the…
Primary objective of the study is•To investigate the change of Urinary Albumin-to-Creatinine ratio (UCAR) after 90 days treatment Secondary objectives of the study are•To assess safety and tolerability of these doses by assessing the effects on…
The objectives of this study are to evaluate the safety and efficacy of AGN-214868 compared with placebo in the treatment of patients with IOAB and urinary incontinence.The clinical hypotheses for this study are:• AGN-214868 has an acceptable safety…
Primary: To compare the pharmacokinetics of raltegravir 400 mg twice daily vs. ralte-gravir 800 mg once daily (QD) by intrasubject comparison. Secondary: To determine the efficacy of an antiretroviral regimen consisting of raltegravir 800mg QD,…
The primary goal is to show the capability of monocyte-derived DC after RNA electroporation for melanoma antigens to induce an immune response.The secondary objective is to show clinical response.
To evaluate the safety and efficacy of the REG1 Anticoagulation System in Acute Coronary Syndrome patients undergoing cardiac catheterization by determination of the clinically acceptable dose range of RB007, which can be used to reliably reverse…
To assess efficacy and safety of temoporfin (Foscan*) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases.
To demonstrate the safety, efficacy, and performance of the Edwards Lifesciences MONARCTM system for the treatment of functional mitral regurgitation
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…
The main objective of the study was to prove the effectiveness of cryoablation in palliating pain and correlate the patients with a matched group of the Dutch bone metastasis study. The secondary objectives are to determine the accuracy of cryoprobe…
The primary objective of this study is to establish the sensitivity and specificity of an oral uracil loading test as a potential screening tool for DPD deficiency