Clinical Trials Logo

Filter by:
NCT ID: NCT01155661 Completed - Clinical trials for Depressive Disorder, Major

A Safety Study in Participants With Major Depressive Disorder

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

The primary objective of this study is to evaluate the long-term safety and tolerability of LY2216684 administered once daily (QD) in the adjunctive treatment with a selective serotonin reuptake inhibitor (SSRI) for up to approximately 1 year in participants with major depressive disorder (MDD) who are partial responders to their SSRI treatment.

NCT ID: NCT01155648 Completed - Critical Care Clinical Trials

Pressure Support During Chest Wall Compression

Start date: May 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to compare two physiotherapy techniques: chest wall compression versus chest wall compression plus increase of 10 cmH2O in inspiratory pressure.

NCT ID: NCT01155297 Not yet recruiting - Clinical trials for Kidney Failure, Chronic

Effect of PT on QL, FC, PWV and Biochemical Markers in CRF on Conservative Treatment

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

Introduction: Chronic Kidney Disease (CKD) is considered an important public health problem, with prevalence of 9.6% in our population. The CKD has as main symptoms fatigue, muscle weakness and poor exercise tolerance, which directly contribute to physical inactivity and low mobility, increasing the risk of morbidity and mortality in CKD patients with significant impact on quality of life of these patients. Thus, patients with CKD have poor quality of life, high incidence of cardiovascular diseases, high prevalence of endothelial dysfunction, the consequent increase in arterial stiffness and serum concentration of asymmetric dimethylarginine (ADMA). It is believed that the conditioning of these patients may reduce cardiovascular risks and improve the quality of life. Aim of the study: Evaluate the impact of exercise training in relation to functional capacity, quality of life, pulse wave velocity and ADMA in patients with CKD on dialysis. Materials and methods: Is a randomized controlled study, with 34 CKD patients on conservative treatment, divided into control group (with stretching exercises and metabolic exercises) and training group, those undergoing physical training, aerobic and resistance during six months. Before and after exercise training, patients will be assessed using the SF-36 and IPAQ. Also be held assessment of pulse wave velocity, measurement of serum ADMA and spirometry testing. Statistical analysis consisted of t test for independent data or chi-square when appropriate.

NCT ID: NCT01155128 Enrolling by invitation - Hypertension Clinical Trials

Effects of an Exercise Program in Patients With Hypertensive Chronic Kidney Disease

Start date: September 2011
Phase: Phase 4
Study type: Interventional

Introduction: Chronic kidney disease (CKD) is now an important public health issue. While 0.1% of the population is on dialysis, approximately 4.5% of subjects have renal dysfunction (glomerular filtration rate <60 ml/min/1.73 m2). These patients have a high mortality of cardiovascular disease (CVD) with low quality of life and survival, despite high expenditure on their treatment. Hypertension (SAH) is both a cause and a complication of CKD. In addition, CKD and hypertension are risk factors for CVD. The nephropathy that are not on dialysis are less studied than those on dialysis. Strategies are needed to maintain renal function in these patients and mitigate the risk factors for CVD. A sedentary lifestyle can be an important determinant of morbidity of mortality. This study aims to determine the effect of exercise in patients with CKD not yet on dialysis. Methodology: A randomized clinical trial in hypertensive patients with CRF. After recruitment of participants and completed baseline surveys, those eligible for inclusion and consented to participate in the study will be randomly assigned. We use the technique of randomization in blocks of fixed size of six persons. Variables to be collected: demographic, socioeconomic, behavioral, anthropometric, blood pressure, laboratory tests (anemia, the lipid profile, blood glucose, inflammatory markers and number of peripheral endothelial progenitor cells) and quality of life. These patients will be re-interviewed in the middle period of the study (10 weeks) at the end of the intervention (20 weeks) and 10 weeks after the end of the intervention. The intervention group will participate in two weekly sessions of exercise. Therefore, facing the epidemic of CKD, this study intends to fill the data gaps about the impact of physical activity in patients with CKD on dialysis.

NCT ID: NCT01155037 Completed - HIV Infection Clinical Trials

Safety of and Immunogenicity to an H1N1 Influenza Vaccine in HIV-infected Adults

VIP-H1N1
Start date: March 2010
Phase: Phase 2
Study type: Interventional

This is a randomized, open label, phase II trial to evaluate the safety and immunogenicity of two different schedules of vaccination against influenza A H1N1 in HIV-infected individuals, in which each of the randomized groups will be compared with HIV-negative volunteers vaccinated with the regimen indicated by the Brazilian National Immunization Program. Will be included in the study HIV-infected patients, stratified by CD4 count (< 200 cells/mm3 or > 200 cells/mm3) at the time of screening for the study, not receiving antiretroviral therapy treatment or receiving stable treatment for at least 8 weeks, with no plans to change over the next 6 months, eligible to receive vaccine against influenza A H1N1. The control group will be formed by HIV-negative individuals, confirmed by serology performed at screening, eligible to receive vaccine against influenza A H1N1. Patients infected with HIV will receive one of two possible vaccination regimens: 1) 3.75 µg in two applications 21 days apart, 2) 7.5 µg in two applications 21 days apart. The volunteers in the control group will receive a single application of 3.75 µg dose of the vaccine. The study's hypotheses are: 1) The vaccine against the H1N1 virus promotes antibody titers above the level specified for protection (seroconversion), being as safe and well tolerated in patients HIV-1 infected as in non HIV-infected volunteers; 2) The proportion of seroconversion for H1N1 virus vaccine at a dose of 3.75 µg in HIV-1-infected patients is similar to the proportion of seroconversion induced by the same vaccine at a dose of 7.5 µg; 3)The proportion of seroconversion with one dose of the vaccine against H1N1 virus is similar to the proportion after the second dose.

NCT ID: NCT01154504 Withdrawn - Heart Failure Clinical Trials

The Role of Adrenomedullin on the Outcome of Severe Heart Failure: a Clinical Randomized Study

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

1. Study Hypothesis: - The decrease of plasma adrenomedullin (ADM) concentration by ultrafiltration and isovolumetric hemofiltration in patients with acute III and IV Class New York Heart Association Functional(NYHA) heart failure is more pronounced than a standard diuretic treatment and is related with clinical improvement. 2. Outcome Measurements: To correlate the adrenomedullin plasma levels with clinical treatment, ultrafiltration and hemofiltration related to: - Brain natriuretic peptide (BNP) level - angiotensin II level - sympathetic nervous activity - oxydative stress - clinical outcome at the beginning, at discharge and 90 days after randomization.

NCT ID: NCT01154140 Completed - Clinical trials for Non Squamous Lung Cancer

A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung

PROFILE 1014
Start date: January 13, 2011
Phase: Phase 3
Study type: Interventional

This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.

NCT ID: NCT01154049 Completed - Schistosomiasis Clinical Trials

Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis

Start date: March 2011
Phase: Phase 1
Study type: Interventional

This is a phase I, open-label, single arm trial, which aims to assess the safety of the vaccine prepared sm14 in healthy subjects. The product immunogenicity will be evaluated by conducting serology (anti-sm14 antibodies) and testing of cellular response to the antigen by the method ELI-SPOT. Each participant will remain in the study for approximately 4 months. The total study duration is 10 months, considering a period of 6 months for inclusion. Will be included in the study subjects male and female, between 18 and 49 years, that manifest their will to participate in the research by signing an Informed Consent Form. Eligible population for the study are subjects who do not present at screening significant changes in renal, cardiac and liver functions, complete blood count, clotting, present no acute or chronic illnesses, are not in the chronic use of any medication, do not have HIV infection or other immunodeficiency. Pregnant or breastfeeding women will not be included. Volunteers will receive three doses of vaccine prepared sm14, in doses containing 50 mcg of the antigen, associated with adjuvant GLA-SE at a dose of 10 mcg, with an interval of 30 days between each application. Twenty volunteers will be included in the study. This is a convenience sample, established for the first test of the product in humans, for the initial safety assessment.

NCT ID: NCT01153074 Completed - Clinical trials for Bronchopleural Fistula

Bronchoscopic Closure of Bronchopleural Fistulas With Occlutech Figulla ASD N Occluder Device

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

The purpose of this study is to evaluate the feasibility of closing bronchopleural fistulas with devices originally developed for correction of cardiac septal defects deployed through bronchoscopic procedures.

NCT ID: NCT01153061 Terminated - Clinical trials for Acquired Tracheo-esophageal Fistula

Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device

TEFGoreHelex
Start date: June 2010
Phase: Phase 4
Study type: Interventional

Endoscopic closure of tracheoesophageal fistulas with a device used for closure of cardiac septal defects.