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NCT ID: NCT01108510 Completed - HIV Infections Clinical Trials

Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

Start date: April 2010
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the safety and efficacy of a regimen containing Cobicistat (COBI)-boosted atazanavir (ATV/co) plus emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus FTC/TDF in HIV-1-infected, antiretroviral treatment-naive adults. Development of COBI as a "pharmacoenhancer" could provide a beneficial alternative to RTV for use in combination with protease inhibitors.

NCT ID: NCT01107886 Completed - Clinical trials for Type 2 Diabetes Mellitus

Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications

SAVOR- TIMI 53
Start date: May 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications

NCT ID: NCT01107418 Completed - Malignant Melanoma Clinical Trials

A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma

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

This open-label study will assess the pharmacokinetics, efficacy and safety of RO5185426 administered as 240mg tablets in previously treated patients with metastatic melanoma. Patients will be randomized to receive one of four dose-levels of RO5185426 [RG7204; PLEXXIKON; PLX4032] orally twice daily on days 1 to 15 (morning dose). Starting on day 22, treatment with RO5185426 may be resumed at a dose of 960 mg twice daily and continued until disease progression. Target sample size is <100 patients.

NCT ID: NCT01106716 Completed - Clinical trials for Postherpetic Neuralgia

Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Postherpetic Neuralgia

Start date: March 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postherpetic neuralgia pain

NCT ID: NCT01106651 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus

Start date: June 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.

NCT ID: NCT01106625 Completed - Clinical trials for Diabetes Mellitus, Type 2

The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)

Start date: May 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.

NCT ID: NCT01106586 Completed - HIV Infections Clinical Trials

Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Start date: April 2010
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.

NCT ID: NCT01106417 Completed - Spinal Stenosis Clinical Trials

Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion

Start date: June 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) at 2 or more adjacent cervical vertebral levels between C3-C4 to C7-T1. All subjects in this study will undergo 2 or 3 level anterior cervical discectomy and fusion with Anterior Cervical Plate Fixation.

NCT ID: NCT01106014 Completed - Clinical trials for Pulmonary Arterial Hypertension

Selexipag (ACT-293987) in Pulmonary Arterial Hypertension

GRIPHON
Start date: December 1, 2009
Phase: Phase 3
Study type: Interventional

The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of selexipag on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.

NCT ID: NCT01105156 Not yet recruiting - Morbid Obesity Clinical Trials

Outcomes of Gastric Band Fills as Found With a Patient Self-reported Questionnaire: The Vomiting, Eating, and Weight Loss (VEW) Questionnaire

Start date: April 2010
Phase: N/A
Study type: Observational

1. Background / Scientific Rationale The VEW (Vomiting, Eating, and Weight Loss) Questionnaire has been developed as a method for the assessment of post bariatric surgery patients, as well as a research tool into the eating behaviour of these patients. Objective VEW Questionnaire Premise If used optimally the VEW score is a valuable tool for patients who have had Laparoscopic Gastric Band Surgery (LAGB). The VEW score will be able to assist clinicians treating patients with a LAGB, specifically the Swedish Adjustable Gastric Band (SAGB), by providing them a tool to enhance patient outcomes. By using the information gained from the VEW questionnaire we can assess many areas of the eating behavior, and adjustment outcomes in patients with Gastric Bands. Hypotheses: - The VEW questionnaire aids in the assessment of the need for gastric band adjustment (up or down in volume) - Comparison of patient factors in those who have had a 1. good outcome (increased weight loss) 2. bad outcomes (vomiting, low weight loss, maladaption), from a gastric band fluid addition - In patients who have had a bad outcome, which factors are more predictive? - Fewer Complications associated with Gastric Band Adjustments - Obstruction - Need for urgent deflation - Pain on eating - Lowering incidence of inappropriate fills - Lower incidence of maladaption - Eating behavior can predict long term outcomes o By comparison of factors in the different quartiles of weight loss (particularly top 25% cf. bottom 25%) - Maintenance of weight loss after 12 months is best achieved by use of behavior modification via improved food tolerances and better eating behavior than by increasing restriction of the band by further adjustments. 12 months is chosen as an arbitrary time where the majority of expected weight loss (45% of expected 50-55% 0f EWL) has been achieved. It is also a time frame by which patients have learnt to use the band appropriately, and the gastric band has had time to be adjusted into its optimal range. - The VEW questionnaire can help predict poor outcomes from a SAGB adjustment. - By analyzing the factors in patients who have returned both acutely (days) or at subsequent visits (weeks) and had fluid removed from their bands. These factors would include pain, vomiting, length of meals, maladaption score, fluid added, etc.