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Web-based attention bias modification treatment for childhood anxiety disorders: a randomized, double-blind, controlled trial

Specific AimsAs reviewed above, childhood anxiety disorders are highly prevalent and debilitating, and there is an urgent need for improvement of current treatment strategies. An innovative, but scarcely examined, treatment option for childhood…

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.

Immunomodulatory effects of Inulin-type fructans in a hepatitis B vaccination study

The present study has 1 primary and 1 secondary objective:1: The primary objective of the present study is to analyse the effects of supplementation with ITFs of different chain lengths and RSC on hepatitis B vaccination efficacy. The main parameter…

Laser therapy for onychomycosis in patients with diabetes at risk for diabetic foot complications
A randomized, double blind controlled trial.

To determine the efficacy and safety of laser therapy in diabetes patients with risk factors for developing diabetic foot complications.

Effects of prophylactic use of haloperidol in critically ill patients with a high risk for delirium

In this study we aim to examine the effects of a low dosage of prophylactic haloperidol in patients with an expected ICU length of stay of >1 day. We use two different dosages of haloperidol in this study to compare with placebo. A dosage of…

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,…

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Alirocumab in Patients with Primary Hypercholesterolemia Not Treated With a Statin

The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen including an alirocumab starting dose of 150 mg Q4W as add-on to non-statin lipid modifying background therapy or as…

Treating cocaine dependence by targeting underlying cognitive processes

The objective of this study is to investigate the effectivity on reducing or cessation of cocaine use of 1) working memory training, 2) N-acetylcysteine, 3) the combination of working memory training and N-acetylcysteine. Clinical measures (cocaine…

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC AND ADULT SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES

Determine efficiency and safety of two different doses of pregabalin as compared to placebo.

A randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III study to evaluate the efficacy, safety and tolerability of intravenous BYM338 at 52 weeks on physical function, muscle strength, and mobility and additional long-term safety up to 2 years in patients with sporadic inclusion body myositis (CBYM338B2203)

Primary: to demonstrate that at least one dose regimen of BYM338 in sporadic inclusion body myositis patients will increase the distance traveled as measured by change from baseline at Week 52 of the 6 minute walking distance test relative to…

(Grand)parenting, oxytocin, and the oxytocin receptor gene: an fMRI and observational study

With the proposed study we aim to gain insight into the effects of oxytocin (OT) on both parents* and grandparents* sensitive, empathic, and protective responses to their (grand)children, and in the neural origins of these responses.The primary…

A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-
Controlled, Multi-center Study to Evaluate the Efficacy, Safety and
Tolerability of Combinations of Solifenacin Succinate and Mirabegron
Compared to Solifenacin Succinate and Mirabegron Monotherapy in the
Treatment of Overactive Bladder

Primary objective *To evaluate the efficacy of 2 dose combinations of solifenacin and mirabegron compared to solifenacin and mirabegron monotherapySecondary objectives*To evaluate the efficacy of 2 dose combinations of solifenacin and mirabegron…

Preservation of metabolic flexibility by acetylcarnitine formation

To test the hypothesis that metabolic inflexibility in pre-diabetic subjects and diabetic patients is due to a reduced capacity to form acetylcarnitines: We aim to investigate whether glucose intolerant subjects have a lower capacity to form acetyl-…

Symptomatic treatment of vascular cognitive impairment

Primary Objective: To study the change on performance on executive function and memory function (as measured on Neurocart), after an active challenge with methylphenidate (monoaminergic) and galantamine (cholinergic), compared to placebo, in…

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia

To evaluate the efficacy (superiority) and safety of BAY 41-6551 as measured by the comparison of the clinical cure rate of aerosolized BAY 41-6551, administered via the PDDS Clinical, versus placebo (normal saline) at the Test-of-Cure (TOC0 visit…

Cholinesterase inhibitors to slow progression of visual hallucinations in Parkinson*s disease: a multi-center placebo-controlled trial (CHEVAL)

investigate whether early treatment with ChEI delays the progression of minor VH to major VH without insight or PDP. In addition, we will measure motor control, psychotic symptoms, cognitive impairment, mood disorders, adverse events and compliance…

Magnetic Resonance Assessment of Victoza Efficacy in the Regression of Cardiovascular Dysfunction In Type 2 Diabetes Mellitus

Study 1:1) To test the hypothesis that Liraglutide improves cardiovascular function in DM2 patients and whether the improvement is associated with redistribution of ectopic fat stores. 2) To test the hypothesis that Liraglutide activates BAT in DM2…

A randomized, double-blind, placebo-controlled, multicenter study to demonstrate the efficacy at 16 weeks of secukinumab 150 and 300 mg s.c. and to assess safety, tolerability and long-term efficacy up to 132 weeks in subjects with moderate to severe palmoplantar psoriasis (CAIN457A2312)

Primary: To demonstrate the superiority of secukinumab 150 mg and/or 300 mg to placebo in subjects with moderate to severe palmoplantar psoriasis as assessed by the palmoplantar Investigator*s Global Assessment (ppIGA) at Week 16.Secondary: Efficacy…

A multicenter, international, randomized, parallel group, double-blind, placebo-controlled, cardiovascular safety and renal microvascular outcome study with linagliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA

The primary objective is to demonstrate non-inferiority (by means of comparing the upper limit of a two-sided 95% confidence interval with the non-inferiority margin of 1.3) of treatment with linagliptin in comparison to placebo (as add-on therapy…

Quadrivalent HPV vaccination after effective treatment of Anal Intraepithelial Neoplasia in HIV+ men (VACCAIN-P)

The primary objective of the current study is to assess the efficacy of qHPV vaccination in preventing recurrence of high-grade AIN in HIV+ MSM with CD4 counts >350 x 10E6/l who were successfully treated for high-grade intra-anal AIN in the…