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NCT ID: NCT00978952 Completed - Clinical trials for Coarctation of the Aorta

Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta

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

This study is designed as a prospective, multicenter, non-randomized, single arm study to assess the safety and effectiveness of the Large Diameter Advanta™ V12 Covered Stent for stent implantation in coarctations of the aorta.

NCT ID: NCT00978510 Completed - Tuberculosis Clinical Trials

Study of Health Personnel and the Assistance to Patients With Tuberculosis in Hospital Environment

Start date: January 2004
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate in hospital environment the knowledge of the health care professionals about fundamental concepts on tuberculosis and the accomplishment to respiratory isolation practices for patients with pulmonary tuberculosis hospitalized in a public hospital in Fortaleza, Ceará, Brazil.

NCT ID: NCT00976937 Completed - Clinical trials for Type 2 Diabetes Mellitus

24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years

Start date: August 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate benefits and risks of lixisenatide (AVE0010), in comparison to sitagliptin, as an add-on treatment to metformin, in obese (body mass index [BMI] greater than or equal to 30 kilogram per square meter [kg/m^2]) type 2 diabetic patients less than 50 years of age, over a period of 24 weeks of treatment. The primary objective of this study is to assess the efficacy of lixisenatide, in comparison to sitagliptin, as an add-on treatment to metformin on a composite endpoint of glycemic control in terms of glycosylated hemoglobin (HbA1c) and body weight, at Week 24. Secondary objectives are to assess the effects of lixisenatide, in comparison to sitagliptin, as an add-on treatment to metformin on absolute changes in HbA1c values and body weight; fasting plasma glucose (FPG); plasma glucose, insulin, C-peptide, glucagon, and proinsulin during a 2-hour standardized meal test; insulin resistance assessed by homeostatic model assessment of insulin resistance (HOMA-IR); beta cell function assessed by homeostatic model assessment of beta-cell function (HOMA-beta); to evaluate safety, tolerability, and anti-lixisenatide antibody development.

NCT ID: NCT00976794 Completed - Bipolar I Disorder Clinical Trials

Efficacy of Combined Treatment for Young Bipolar I Disorder

LICAVAL
Start date: January 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the efficacy of the combination of lithium and carbamazepine compared with lithium and valproate treating young bipolar patients.

NCT ID: NCT00976547 Completed - Depression Clinical Trials

Correlation Analysis of Hearing Thresholds, Validated Questionnaires and Psychoacoustic Measurements in Tinnitus Patients

Start date: January 2009
Phase: N/A
Study type: Observational

Objective: To evaluate the correlation between audiometric thresholds, pitch matching (PM), minimum masking level (MML), Tinnitus Handicap Inventory (THI) and the Beck Depression Inventory (BDI) in tinnitus patients. Subjects: 48 patients with tinnitus as the main complaint from OTOSUL, Otorrinolaringologia Sul-Fluminense, Volta Redonda, RJ, Brasil and Centro de Tratamento e Pesquisa em Zumbido, Belo Horizonte, MG, Brasil. Method: Subjects performed tonal audiometry, Pitch Matching (PM) and Minimum Masking Level (MML) for tinnitus. They also fulfilled the Tinnitus Handicap Inventory (THI) and Beck Depression Inventory (BDI). Data was statistically compared for correlation between audiometric thresholds, psycho-acoustic measures and questionnaires.

NCT ID: NCT00976391 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine

Start date: September 2009
Phase: Phase 3
Study type: Interventional

This study will examine the safety and efficacy of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes.

NCT ID: NCT00975741 Completed - Asthma Clinical Trials

Efficacy and Safety of Two Dry Power Inhalers (DPIs) Used for the Application of Mometasone in the Treatment of Asthma

Start date: October 2002
Phase: Phase 3
Study type: Interventional

Mometasone furoate (MF) is a new potent synthetic corticosteroid. Internationally, MF is administered by a breath-actuated DPI and supplied in multidose devices. Capsules to be administered through a monodose device that would offer an alternative to MF DPI multidose treatment in terms of cost-effectiveness were developed in Brazil. The aim of the present non-inferiority clinical study was to evaluate both devices in terms of efficacy and safety.

NCT ID: NCT00975286 Completed - Clinical trials for Type 2 Diabetes Mellitus

24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

GetGoal Duo1
Start date: October 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment. The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (<) 7 percent (%) and less than or equal to (<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.

NCT ID: NCT00975195 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease

Start date: February 2009
Phase: Phase 4
Study type: Interventional

This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.

NCT ID: NCT00973128 Completed - Clinical trials for Cutaneous Leishmaniasis

Reduced Doses of Antimony Plus Ranulocyte Monocyte Colony Stimulating Factor (GM-CSF) for Cutaneous Leishmaniasis

GMCSFSbv
Start date: February 2004
Phase: Phase 2
Study type: Interventional

The present study was designed as a randomized, single blind, placebo-controlled, study to evaluate the effect of 400 µg of recombinant human GM-CSF applied intralesionally and associated with half of the total dose of antimony in a reduced time schedule (20mgSbV/Kg/d for 10 days) as compared to the full dose of antimony (20mgSbV/Kg/d for 20 days) to treat cutaneous leishmaniasis ulcers.