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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…

Use of guided imagery in patients with fibromyalgia: effects on pain, self agency and physical functioning

The main objective is to gain insight into the effects of guided imagery on pain, self efficacy and functional status of people with fibromyalgia and into the relationships between these outcome variables.

Rotational malalignment of the lower leg after intramedullary osteosynthesis (ROMIO).

Is the present malrotation of the tibia, 15 degrees exorotation and 10 degrees endorotation, after intramedullary nailing acceptabel. Furthermore, we want to know which technique could reduce the possible malalignment in patients. In present there…

Prospective, randomised, open-label study to skin-friendliness and usability of Delta-dry vs. regular padding at lower-arm cast, scaphoïd cast and lower-leg cast.

How friendly is Delta-dry to the skin versus regular padding?Will Delta-dry be more functional than regular padding in patient experience? (Functional as in daily activity's concentrated to getting wet of the cast) How is the processability of…

Effects of drama therapy on anxiety and mood disorders of adolescents compared to care as usual.

The objectives of the study are:Developing an experimental design to obtain empirical data about the effects of a drama intervention on anxiety and mood disorders of adolescents.

Clinical and immunological effects of imiquimod and HPV-vaccination compared to imiquimod alone in female patients with Usual type VIN: proof of principle.

Primary objectives: (1) Evaluation of the efficacy of vaccination against HPV 16, 18, 6 and 11 followed by local applications of imiquimod 5% cream compared to treatment with imiquimod alone for usual type VIN, (2) evaluation of the systemic and…

Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination with Methotrexate, Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Primary Objective:To preliminarily evaluate the efficacy of GLPG0259 compared with placebo in terms of the proportion of subjects achieving ACR20 at Week 12 (Visit [V]7).Secondary Objectives:•To evaluate the efficacy of GLPG0259 compared with…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Evaluating the Efficacy and Safety of IPI-504 in Patients with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors Following Failure of at Least Imatinib and Sunitinib

The primary objective of this study is to compare the progression free survival (PFS) following administration of IPI-504 plus best supportive care versus placebo plus best supportive care in patients with metastatic and/or unresectable…

A Prospective, randomized , placebo, controlled trial ( double blinded) to assess the potential role of vitamin D treatment in breast cancer patients

To assess impact of high doses vitamin D on tumour histology in breast cancer patients

A randomized trial of shortterm inpatient Dialectic Behaviour Treatment (DBT)versus longterm outpatient DBT

This document aims to be a proposal for a research into the efficacy of inpatient DGT. Research results of standard outpatient DGT (executed within minimal one year, without aftercare) in treating chronically impulsive and/or self harming behaviour…

Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% for Prevention and Treatment of Ocular Inflammation and Pain after Cataract Surgery

The objectives of this study are to demonstrate that Nepafenac Ophthalmic Suspension, 0.3% is not inferior to Nepafenac Ophthalmic Suspension, 0.1% (NEVANAC®); Nepafenac Ophthalmic Suspension, 0.3% is superior to Nepafenac 0.3% Vehicle and NEVANAC…

Self-reported influenza-like symptoms among elderly

Primary Objective: • To determine the efficacy of 13vPnC in preventing a first episode of self-reported ILI.Secondary Objectives: • To determine the efficacy of 13vPnC in preventing a first episode of self-reported LRTI.• To determine the incidence…

The effects of plant stanols on the immune function of asthma patients

The major research objective is to prove that the consumption of plant stanol ester enriched yogurts can improve immune function in vivo in asthma patients

Glenohumeral translation and range of movement analysis in patients following surgical open and arthroscopic Bankart repair

Evaluation of pre- and postoperative glenohumeral translation and function (especially exorotation) after open (modified) Bankart procedure versus arthroscopic stabilizing surgery for posttraumatic recurrent shoulder instability.

A better view of your Self: strengthening your self-image in order to counter anxiety and depression. A randomized trial of the effectiveness of a guided self-help intervention.

To study the effectiveness of a low-threshold guided self-help intervention targeted at improving one's self image in people with anxiety and/or depressive symptoms and low self esteem. We expect to find both a significant improvement of self-…

Joint distraction (KJD) in treatment of knee osteoarthritis: a comparison with a presently applied surgical alternative: high tibial osteotomy (HTO)

1. To compare cartilage repair between KJD and HTO, evaluated 2 years post treatment. The hypothesis is that KJD results in (more) cartilage repair compared to HTO. 2. To compare cartilage tissue repair over 2 year follow-up compared to baseline and…

Optimalisation of fluid balance with Flowtrac/Vigileo during HIPEC procedures

reduction of fluid administration of 30%

Wear rate of a Highly Cross-Linked polyethylene stabilized with vitamin E in Total Hip Arthroplasty.;A Randomized Controlled Trial

2.1 Primary objectiveTo compare the wear rate 24 months after THA of HXLPE stabilized with vitamin E versus conventional UHMWPE for total joint arthroplasty.2.2 Secondary objectives1. To compare the wear rate at 3,12 and 24 months after THA between…

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.

A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy

Part A:To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeksPart B:• To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of RA at 24…