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NCT ID: NCT01317524 Completed - Inflammation Clinical Trials

The Effects of Homogenized and Unhomogenized Milk on Postprandial Metabolism in Healthy Overweight Men

Start date: February 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effects of homogenized, unhomogenized and skimmed milk on postprandial metabolism in healthy overweight men

NCT ID: NCT01317511 Completed - Muscle Synthesis Clinical Trials

Protein Supply in Elderly

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

Stimulating overnight muscle protein synthesis, might augment muscle hypertrophy, increase mitochondrial mass, and/or improve muscle tissue repair. The goal of this proposal will be to provide further insight into the responsiveness of the muscle protein synthetic machinery to food intake in relation to age.

NCT ID: NCT01316731 Completed - Exercise Clinical Trials

MyoGene: Effects of Acute Exercise on (Myokine) Gene Expression in Human Skeletal Muscle

Start date: February 2011
Phase: N/A
Study type: Interventional

Rationale: Proteins released from muscle during and shortly after exercise, often referred to as myokines, may be central to our understanding of the cross-talk during and after exercise between skeletal muscles and other organs, in particular the liver. So far only a few myokines are identified (e.g. IL-6, IL-8, IL-15, TNF-alpha). Taking into account the role of these several known myokines in developing insulin resistance, revealing new putative myokines might provide valuable information and a direction for future research on the pathogenesis and treatment of type 2 diabetes mellitus. Objective: The objective of the present study is to identify novel myokines, expression of which is altered in skeletal muscle after a single bout of exercise. Study design: experimental study. Study population: Ten healthy, male subjects between 40 and 60 years of age and BMI < 30 kg/m2, will participate in this study. Intervention: A single exercise bout that consists of one hour one-legged cycling on a adapted recumbent cycle ergometer at a submaximal rate. The non-exercising leg will serve as control for the exercising leg. Main study outcomes: Main study outcomes include upregulation of genes in skeletal muscle after exercise (with a focus on genes encoding myokines) and changes of blood plasma levels of selected proteins after exercise.

NCT ID: NCT01316276 Completed - Cystic Fibrosis Clinical Trials

Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection

Start date: October 5, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long term safety and tolerability of Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic infection due to pseudomonas aeruginosa. This long-term, open-label, multi-cycle extension study enrolled subjects who had successfully completed study TR02-108, were compliant with the study protocol, and did not meet any of the listed study discontinuation criteria. The safety and tolerability of LAI were evaluated for up to approximately 2 years.

NCT ID: NCT01316263 Completed - Clinical trials for Gastrointestinal Stromal Tumor (GIST)

A Study of IMC-3G3 in Previously Treated Patients With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors

Start date: August 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the tumor response of stable disease (SD) partial response, or complete response (according to RECIST 1.1 criteria) at 12 weeks in patients with Gastrointestinal Stromal Tumors (GIST) harboring PDGFRα mutations and patients with GIST not harboring PDGFRα mutations.

NCT ID: NCT01315678 Completed - Clinical trials for Pseudomonas Aeruginosa Infection

Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections

Start date: February 29, 2012
Phase: Phase 3
Study type: Interventional

A major factor in the respiratory health of Cystic Fibrosis (CF) participants is the prevalence of chronic Pseudomonas aeruginosa (Pa) infections. The Pa infection rate in CF patients increases with age and by age 18 years approximately 85% of CF patients in the US are infected. Liposomal amikacin for inhalation (Arikayce™) was developed as a possible treatment for chronic infection due to Pa in CF patients. The purpose of this study is to determine whether Arikayce™ is effective in treating chronic lung infections caused by Pa in CF participants. The effectiveness, safety, and tolerability of Arikayce™ will be compared to Tobramycin TOBI®, an inhalation antibiotic already available for use.

NCT ID: NCT01314716 Completed - Bronchiectasis Clinical Trials

Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis

AIR-BX2
Start date: April 2011
Phase: Phase 3
Study type: Interventional

The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.

NCT ID: NCT01314040 Completed - Clinical trials for Identify New Biomarkers in Blood or Urine After Consumption of Meat Protein, Dairy Protein and Grain Protein in Healthy Subjects.

Study to Identify Biomarkers for Protein Intake

Biomarker
Start date: March 2011
Phase: N/A
Study type: Interventional

Results from observational studies suggest a small beneficial association between protein and blood pressure that may be mainly attributable to the intake of protein from plant sources. In epidemiological studies biomarkers of dietary intake are useful to estimate intake more reliably. Dietary studies using biomarkers of protein intake generally show stronger associations with health outcomes. However, data on biomarkers for specific types of protein (e.g. from dairy, meat, grain and legumes) are scarce. Therefore the purpose of this study is to identify new biomarkers for the intake of protein from meat, dairy and grain. In addition the secondary purpose is to investigate whether intake of protein from these sources influences kidney filtration rate and urinary acid excretion differentially.

NCT ID: NCT01313676 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease

Start date: January 25, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease.

NCT ID: NCT01313637 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD

DB2113361
Start date: March 1, 2011
Phase: Phase 3
Study type: Interventional

This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).