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NCT ID: NCT01793896 Terminated - Metabolic Syndrome Clinical Trials

Beneficial Effects of Exercise and Healthy Diets on Muscle and Adipose Tissue

Start date: July 2013
Phase: N/A
Study type: Interventional

Both dietary caloric restriction (CR) and physical exercise (PE) exert beneficial effects, which retard or prevent age-related diseases and prolong life span. Subjects with the metabolic syndrome age prematurely, therefore preventive measures should be initiated early. The present study intends to demonstrate that physical exercise and/or Mediterranean diet, in middle aged volunteers with the metabolic syndrome, preserve adequate adipose tissue functionality and retard skeletal muscle aging (assessed by mitochondrial biogenesis and accumulation of ROS), by activating several pathways, homologous to CR. The investigators plan to study this by using two approaches: 1) A cross- sectional model, in which the expression of the mentioned metabolic mediators, indicators of muscle mitochondrial biogenesis and muscle oxidative damage will be compared between men with different body compositions, fat distribution, muscle strength and exercise capacity (VO2max). Also, in these men the investigators will assess the expression of uncoupling protein 1 (UCP1) in subcutaneous white adipose tissue (as a measure of adaptive thermogenesis), and inflammatory markers (Interleukin 1-6, Interleukin 1ß and CCL2 chemokine (C-C motif ligand 2)) in preperitoneal adipose tissue, plus inflammation and adipogenesis potential of their cultured preadipocytes. Moreover, in vitro studies will evaluate the functional effects of exposure of a cell lyne of human adipocyte cells (LS14)to factors secreted by media conditioned by the patients´ adipose tissue explants. 2) A prospective intervention in overweight/moderately obese middle aged volunteers that will be assigned to a weight-maintenance period (as a control group), and then randomly y assigned to a Mediterranean diet, exercise training or diet plus training. Before and after 3 months of intervention the investigators will obtain muscle tissue samples to study the expression of Peroxisome proliferator activated receptor (PPAR) gamma coactivator 1 alpha (PGC1), uncoupling protein 3 (UCP3), AMP activated protein kinase (AMPK), Sirtuin 1 (SIRT-1), mitochondrial DNA and oxidative damage indicators (8-oxo-7,8-dihydro-2-deoxyguanosine (oxodG), carboxymethyllysine (CML and its receptor (RAGE)). In vitro studies will evaluate the effect of circulating factors from the patients (serum) on LS14 inflammatory and adipogenic potential, at baseline and after 3 months of intervention.

NCT ID: NCT01782326 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study

Start date: July 2013
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.

NCT ID: NCT01778829 Recruiting - Clinical trials for Neonatal Respiratory Failure

Non Invasive Ventilation Versus Continuous Positive Airway Pressure After Extubation of Very Low Birth Weight Infants.

VNINS
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Nasal intermittent positive pressure ventilation (NIPPV) non synchronized is better than continuous positive airway pressure (NCPAP)in preventing extubation failure within 72 h, after extubation of very low birth weight infants at the NEOCOSUR Network.

NCT ID: NCT01777256 Terminated - Clinical trials for Systemic Lupus Erythematosus

An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184

Start date: March 1, 2013
Phase: Phase 2
Study type: Interventional

This is an adaptive, dose ranging, Phase II study to investigate the relationship between repeat doses of GSK2586184 and the pharmacodynamic effect and clinical efficacy in patients with active systemic lupus erythematosus (SLE). This study will also investigate the safety and tolerability of repeat doses of GSK2586184. During the study, up to 3 Interim Analyses will be conducted. These are to monitor the pharmacodynamic effect and safety following 2 weeks of therapy (Interim Analysis 1); and the clinical efficacy and safety of GSK2586184 following 12 weeks of therapy (Interim Analyses 2 and 3). Subjects who meet the entry criteria (approximately 150 to 250) will be randomized in a 1:1:1:1:1 ratio to receive GSK2586184 at doses of 50 milligram (mg) twice daily (b.i.d), 100 mg b.i.d, 200 mg b.i.d, 400 mg b.i.d or Placebo b.i.d. GSK2586184 tablets available in 50 and 200 mg dose strength will be administered orally up to 12 weeks. Subjects who complete the study will participate in the study for approximately 21 weeks.

NCT ID: NCT01776424 Completed - Clinical trials for Prevention & Control

Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease

COMPASS
Start date: February 28, 2013
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are: - To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD); - To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.

NCT ID: NCT01774266 Recruiting - Clinical trials for Early Gastric Cancer

Detection of Methylated Reprimo in Plasma for Asymptomatic Gastric Cancer

DEMRAC
Start date: September 2012
Phase: N/A
Study type: Observational

In this proposal the investigators aim to develop a commercial kit to be used in primary screening and non-invasive triage for early detection of gastric cancer. This kit will be cost-effective and more accessible to the general population. In addition, the investigators would like to expand our current patent already submitted to INAPI (National Institute for Intellectual Property) and propose royalties to biomedical diagnostic companies for the use of our product at international level.

NCT ID: NCT01772147 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Efficacy and Safety of the Addition of Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily to 2 Doses of Umeclidinium Bromide Inhalation Powder (62.5 or 125mcg) Once-daily Over 12 Weeks.

Start date: January 2013
Phase: Phase 3
Study type: Interventional

The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily and umeclidinium bromide (125mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily with placebo when added to fluticasone propionate (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.

NCT ID: NCT01768559 Completed - Type 2 Diabetes Clinical Trials

Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients

GetGoal Duo-2
Start date: January 2013
Phase: Phase 3
Study type: Interventional

Primary Objective: - To compare lixisenatide versus insulin glulisine in terms of HbA1c reduction and body weight change at week 26 in type 2 diabetic patients not adequately controlled on insulin glargine ± metformin. Secondary Objectives: - To compare the treatments/regimens on: - The percentage of patients reaching the target of HbA1c <7% or ≤6.5% - Body weight - Self-Monitored Glucose profiles - Fasting Plasma Glucose (FPG) - Post-prandial plasma glucose /glucose excursions during a standardized meal test (subset of patients) - Daily doses of insulins - Safety and tolerability

NCT ID: NCT01766817 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis

Start date: January 31, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if study drug (BMS-986020) dose of 600 mg once daily or 600 mg twice daily for 26 weeks compared with placebo will reduce the decline in forced vital capacity (FVC) and will be well tolerated in subjects with idiopathic pulmonary fibrosis (IPF).

NCT ID: NCT01764997 Terminated - Clinical trials for Rheumatoid Arthritis

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

RA-COMPARE
Start date: April 2013
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and methotrexate (MTX) in patients with rheumatoid arthritis (RA) and an inadequate response to adalimumab and methotrexate by evaluation of the Disease Activity Score for 28 joints (DAS28). Secondary Objectives: To assess the signs and symptoms of rheumatoid arthritis (RA) in patients taking sarilumab in combination with methotrexate (MTX). To assess the quality of life of patients with rheumatoid arthritis (RA) taking sarilumab in combination with methotrexate (MTX). To assess the safety and tolerability of sarilumab in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA).