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NCT ID: NCT01112423 Completed - Dyslipidemia Clinical Trials

Safety Study of BMS-823778 in Subjects With Hypercholesterolemia

Start date: June 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)

NCT ID: NCT01112306 Completed - Clinical trials for Pulmonary Arterial Hypertension

ACT-293987 in Pulmonary Arterial Hypertension

Start date: July 7, 2010
Phase: Phase 3
Study type: Interventional

Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)

NCT ID: NCT01111955 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety Study of BMS-823778 in Subjects With Type 2 Diabetes

Start date: July 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on fasting plasma glucose (FPG).

NCT ID: NCT01111552 Terminated - Clinical trials for Major Depressive Disorder (MDD)

Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

Start date: July 29, 2010
Phase: Phase 3
Study type: Interventional

This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for the current MDD episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant other than Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive symptom severity as assessed by the participant's self-report on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the investigator as part of the participant's medical and psychiatric history. An adequate trial is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for combination treatments) at an approved dose as specified in the ATRQ.

NCT ID: NCT01111409 Completed - Clinical trials for Pelvic Organ Prolapse

A Pilot Study to Evaluate the Clinical Effectiveness and Safety of the VFIX Device as Treatment for Apical Prolapse

Start date: March 2010
Phase: N/A
Study type: Interventional

The primary objective of this pilot study is to evaluate the safety and effectiveness of the VFIX device in maintaining vaginal apical support for at least 6 months in women with symptomatic apical prolapse (upper vaginal or uterine prolapse).

NCT ID: NCT01110915 Completed - Clinical trials for Magnetic Resonance Imaging

Advisa MRI Clinical Study

Start date: June 2010
Phase: N/A
Study type: Interventional

The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body including the chest).

NCT ID: NCT01110720 Completed - Clinical trials for Progressive Supranuclear Palsy

Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy

Start date: October 2010
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of davunetide for the treatment of Progressive Supranuclear Palsy.

NCT ID: NCT01110265 Completed - Clinical trials for Body Dissatisfaction

Attention Training and Its Effects on Body Image Disturbance

Start date: June 2009
Phase: N/A
Study type: Interventional

Research has consistently found attentional biases towards negative weight-related stimuli in individuals with eating disorders. It has been suggested that these biases may act as a vulnerability factor for the development and maintenance of body dissatisfaction and may therefore be an important target for intervention. Previous studies have demonstrated the capacity to modify the patterns of attention allocation to threatening stimuli in a variety of anxiety disorders, with a subsequent and sustained reduction in anxiety symptoms. Thus, the present study aimed at testing the efficacy of attention training in reducing attentional biases and eating disorder symptoms in individuals with elevated levels of body image disturbance and eating disorder symptomatology of clinical severity. Thirty-two participants were randomly allocated to receive eight sessions of a 10-minute computer task aimed at training their attention away from weight-related stimuli or a control placebo training condition. Results showed that participants in the attention training group had a significantly greater reduction in their attentional bias and body dissatisfaction from pre- to post-training relative to the placebo condition. At follow-up, both groups showed a significant decrease in body dissatisfaction from their pre-training levels. The only significant difference between groups in eating disorder symptoms at follow-up was in terms of the attention training group experiencing a greater reduction in weight and shape concerns.

NCT ID: NCT01110031 Completed - Clinical trials for Leukaemia, Lymphocytic, Chronic

Ofatumumab Cardiac Repolarization (QTc) Study in Fludarabine-Refractory Chronic Lymphocytic Leukemia Subjects

Start date: May 13, 2010
Phase: Phase 1
Study type: Interventional

Ofatumumab is a fully-human monoclonal antibody that exhibits high binding affinity to an antigen on the surface of B lymphocytes. Antigen engagement by ofatumumab results in maximal B-cell killing through complement-dependent cytotoxicity and antigen-dependent cellular cytotoxicity in both antigen high- and low-expressing cells. Recent research has shown that ofatumumab-dependent B-cell depletion provides clinical benefit to subjects with CD20-positive cancers such as chronic lymphocytic leukemia (CLL). The purpose of the current study is to assess the impact of ofatumumab on electrocardiographic parameters with particular focus on cardiac repolarization (QTc interval duration) in subjects with refractory CLL. Subjects enrolled in this open-label, single-arm trial will receive ofatumumab at the highest clinical dose (2000 mg) studied or planned for study. Ofatumumab will be administered as eight weekly intravenous (IV) infusions followed by four monthly infusions, beginning in Week 13, across a 25-week treatment period. Cardiovascular effects will be evaluated during treatment through routine 12-lead electrocardiographic (ECG) monitoring. The pharmacokinetic relationship between plasma concentration of ofatumumab and its effect on QTc interval duration will be examined. Specifically, ECG assessments will be collected in triplicate at baseline, at the time of maximum ofatumumab concentrations periodically on-therapy, and at the end of treatment. After completion of the final ofatumumab infusion, subjects will continue to be followed for safety and efficacy for six months relative to the last ofatumumab dose.

NCT ID: NCT01109056 Completed - Pterygium Clinical Trials

Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium

Start date: June 2010
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).