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NCT ID: NCT01034345 Recruiting - Clinical trials for Liver Transplantation

Effect of Rapamycin on Tolerance-related Biomarkers on Stable Liver Transplant Recipients

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

In contrast to calcineurin inhibitors, sirolimus is known to exert remarkable tolerance-promoting properties in multiple animal transplant models. Whether sirolimus is capable of enhancing tolerance-related pathways and/or promoting complete withdrawal of immunosuppressive drugs in human transplant recipients has not been previously addressed. The goal of the investigators study is to evaluate the effects of sirolimus on previously identified tolerogenic pathways in humans and, indirectly, to assess the capacity of this drug to enhance the proportion of liver recipients undergoing successful immunosuppression weaning.

NCT ID: NCT01025947 Recruiting - Stroke Clinical Trials

"Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder (ILR)"

CRYPTONITE
Start date: March 2009
Phase: N/A
Study type: Observational

STUDY TYPE: Prospective, national , multicenter, and observational study. OBJECTIVE: To assess the incidence of AF in patients with cryptogenic stroke who have implanted an AF detection device during a period of 2 years. DEVICE: Reveal XT 9529 (SQDM) SAMPLE SIZE AND STUDY DURATION: 100 patients enrolled which will be followed during a period of 2 years.

NCT ID: NCT01006213 Recruiting - Obesity Clinical Trials

Group Motivational Intervention in Overweight/Obese Patients

IMOAP
Start date: January 2008
Phase: N/A
Study type: Interventional

Overall mortality, such as that caused by cardiovascular disease, increases as weight increases. In the Framingham Study, it was shown that obesity is a cardiovascular risk factor independent of other risk factors such as type 2 diabetes mellitus, dyslipidemia and smoking. Objectives: 1. To determine whether a group motivational intervention is more effective than the standard intervention for treatment of overweight and obesity and most importantly to maintain the attained weight loss on a permanent basis. 2. To assess whether this intervention is more effective than reducing cardiovascular risk factors (lipid profile, apo B-100, apo A-1, fibrinogen, C-reactive protein, hypertension, diabetes mellitus) associated with overweight and obesity, and the overall cardiovascular risk in these patients. Design: Randomized, multicenter, interventional clinical trial in patients with overweight and obesity. Randomized assignment of the intervention by Basic Health Areas (BHAs). Two groups will be established in geographically separate areas, one of which will receive the group motivational intervention (intervention group) and the other will receive standard follow-up (control group). BHAs located in the same building will be assigned the same group (control or intervention) to avoid potential contamination. hypertensive treatment or with a diagnosis of hypertension in their clinical history. Study Scope: Primary care. The study will be conducted in 24 BHAs of Hospitalet de Llobregat and Barcelona during 26months follow-up period. Haematic analyses will be in the carried out at the reference laboratory.

NCT ID: NCT01000233 Recruiting - Aortic Stenosis Clinical Trials

Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications

CALCIFICA
Start date: August 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Intervention study focused on preventing the progression of aortic valve calcification. Vascular and cardiac calcifications are a marker of risk and poor outcome, especially the severe calcified aortic stenosis and coronary calcification. Its increasing prevalence is now a health problem. The knowledge and the therapeutic objective of this condition have changed in recent years and pathophysiological aspects at present, focus on atherosclerotic disease and inflammation. Several clinical trials have failed to demonstrate that statins or ACE inhibitors prevent the progression of cardiovascular calcification. Taking into account the new concepts of ectopic calcification and research results from our group, the most logical approach to prevent progression would be an early intervention and management of the calcification inhibiting agents such as phytate (inositol six-phosphate -- InsP6). Hypothesis: The phytate prevents or delays the progression of cardiovascular calcification. It is a clinical trial of intervention of oral phytate (InsP6) in patients with mild to moderate cardiovascular calcification (aortic valve and / or coronary arteries) compared with placebo over a period of 24 months. It is a prospective, randomized minimization of variables to ensure homogeneity of the groups. The primary analysis will be the time evolution of the extent of calcium in the aortic valve and coronary arteries made with CT. Secondary variables are the degree of progression of aortic stenosis and clinical events (death, stroke, angina, stroke and cancer of any type).

NCT ID: NCT00999739 Recruiting - HIV Infections Clinical Trials

Conjugate And Polysaccharide Vaccines Compared With Polysaccharide Vaccine In Hiv-Infected Adults

Start date: December 2007
Phase: Phase 3
Study type: Interventional

Randomised study comparing two pneumococcal vaccination strategies in HIV-infected adults with moderate immunossupression (CD4 between 200 and 500 cells/uL and viral load under 5logs), one with conjugated heptavalent vaccine(Prevenar, Wyeth-Lederle) followed by polysaccharide vaccine 4 weeks after (Aventis-Pasteur), and two with one dose of polysaccharide vaccine. Determination of secondary effects related to both vaccines and determination of antibody concentration (ELISA) and avidity (ELISA with thiocyanate) and opsonophagocytosis killing activity against the seven serotypes included in the heptavalent vaccine before vaccination, at 4 weeks, at 8 weeks, at48 weeks and 96 weeks. A sample of 220 HIV-infected adults (110 in each group) will be needed to detect differences of 10% for a type I error o 5% for a limited population of 2500 HIV-infected adults. The main hypothesis are :the immunogenicity of pneumococcal vaccination with conjugate and polysaccharide vaccines is superior to immunogenicity induced by polysaccharide vaccination alone(antibody concentration), the avidity and opsonophagocytosis induced by two vaccines is better than the one after polysaccharide vaccine alone, both vaccinations are safe.

NCT ID: NCT00984178 Recruiting - Clinical trials for Reperfused Acute Myocardial Infarction

Trial of Hematopoietic Stem Cells in Acute Myocardial Infarction

TECAM2
Start date: November 2005
Phase: Phase 2
Study type: Interventional

The aim of this study is to compare the effectiveness of four different strategies for preventing the ventricular postinfarction remodelling: 1) Conventional treatment for reperfunded extensive acute myocardial infarction, 2) Autologous bone marrow stem-cells intracoronary transplantation 3) mobilization of bone marrow stem-cells induced by granulocyte colony-stimulating factors (G-CSF); and 4) combined treatment (stem-cells transplantation plus mobilization with G-CSF).

NCT ID: NCT00941083 Recruiting - HIV Infections Clinical Trials

Simplification From Protease Inhibitors to Raltegravir

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

A switch from protease inhibitors (PIs) to raltegravir (RAL) will be effective virologically and immunologically. Moreover, it will be associated with significant improvements in the lipid profile in HIV patients with undetectable viremia on PIs. In this setting, RAL once a day (QD) will perform as well as RAL twice a day (BID).

NCT ID: NCT00931450 Recruiting - Breast Cancer Clinical Trials

Sunitinib Malate and Exemestane in Treating Postmenopausal Women With Breast Cancer

Start date: March 2009
Phase: Phase 1/Phase 2
Study type: Interventional

RATIONALE: Sunitinib malate and exemestane may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving sunitinib malate and exemestane before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of sunitinib malate to see how well it works when given together with exemestane in treating postmenopausal women with breast cancer.

NCT ID: NCT00916695 Recruiting - Clinical trials for Coronary Artery Disease

Everolimus-Eluting Stent for Bifurcation Coronary Lesions: Comparison of Simple Versus Complex Techniques

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

The purpose of this study is to evaluate the efficacy and safety of the treatment of true bifurcation lesions with the XIENCE V stent using the simple strategy (stent in main vessel and provisional T-stenting in the side branch) compared to the complex strategy (stent in main vessel and T-stenting in the side branch).

NCT ID: NCT00908336 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

Erlotinib and Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of One Chemotherapy Regimen

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

Erlotinib has demonstrated efficacy as a single agent in patients with NSCLC and the addition of erlotinib to chemotherapy has not achieved better results in the general population. However, several preclinical and phase I studies have shown that a sequential treatment of erlotinib and chemotherapy could avoid a possible negative interaction between both drugs when administrated concomitantly, and therefore, it could improve the benefit of the combination therapy. This study will investigate if the intermittent treatment of a chemotherapy drug, such as docetaxel, with erlotinib could achieve a clinical benefit.