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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…

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

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

A randomized, placebo-controlled, double blind, 4-period, cross-over trial, to study the effects of aliskiren, hydrochlorothiazide and moxonidine on endothelial dysfunction in obesity related hypertension

Primary objective: to compare changes in endothelial function in patients with obesity related hypertension after 8 weeks of treatment with aliskiren, moxonidine and HCTZ.Secondary objectives: to compare changes in the following parameters in…

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…

Durable-Response Therapy Evaluation For Early -or New-Onset Type 1 Diabetes.

Primary objective:* To demonstrate that subjects who receive an 8-day series of Otelixizumab infusions have greater improvement than subjects who receive placebo in endogenous insulin secretion at 12 months after study drug administration. Secondary…

A randomized, double-blind, placebo-controlled, serial-cohort, single ascending dose of Xen2174 with bupivacaine interaction study administered intrathecally in healthy volunteers.

The objectives of the study are:To determine the pharmacokinetic and pharmacodynamic interaction of a single ascending dose of Xen2174 with bupivacaine, and in one cohort of Xen2174 alone, when administered intrathecally to healthy volunteers and…

The role of the endocannabinoid system in Attention-Deficit/Hyperactivity Disorder and symptoms: a pharmacological fMRI study

To establish if and how the endocannabinoid system is involved in ADHD and related symptoms. This will be investigated by assessing the acute effects of a cannabinoid agonist (THC) on brain function related to ADHD and ADHD symptoms.

A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus

Primary: The primary objective of this study is to assess relative to placebo, the efficacyof teplizumab when administered according to 3 different teplizumab dosing regimens in subjects with recent-onset T1DM (within 12 weeks of presentation of…

Women*s Hormonal Intervention Study in early Postmenopause of Estradiol-progesterone Replacement therapy - effects on quality of life

The primary objective is to evaluate health related QoL under an oral sequential treatment with natural steroid hormones: Duogestan®. The secondary objective is to evaluate the bleeding patterns over a one-year period.

STUDY TO INVESTIGATE THE EFFECTS OF LEVOCETIRIZINE AND DIPHENHYDRAMINE ON COGNITIVE AND PSYCHOMOTOR FUNCTIONING DURING SIMULATED DIVING AT 2 BAR AND 4 BAR IN PROFESSIONAL NAVY DIVERS

Investigate the effects of levocetirizine, diphenhydramine and placebo on cognitive and psychomotor functioning during controlled simulated diving in a recompression chamber in professional navy divers at 10 mt (2 bar) and 30 mt (4 bar).

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis.

1. Primary Objectives of the study: The primary objectives of this study are to evaluate the efficacy and safety of 2 SC dosing tiers of ustekinumab in the treatment of adolescent subjects * 12 to < 18 years of age with moderate to severe…

Naltrexone as anti-craving medication in cannabis addicts

The goal of the proposed study is to build knowledge about the effect of Naltrexone in a regular sample of cannabis addicts in a mid-size town. To accomplish this, we propose to: a) do a double blind randomized controlled trial with Naltrexone in…

Navigation ability after stroke

Primary objective: To create diagnostic and treatment tools for navigation ability in stroke patients, that can be used in clinical practice.Secondary objective: To increase knowledge about the cognitive structure and neuroanatomical correlates of…