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NCT ID: NCT01306214 Completed - Obesity Clinical Trials

Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus

Start date: February 2011
Phase: Phase 3
Study type: Interventional

This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.

NCT ID: NCT01305746 Completed - Clinical trials for Systemic Lupus Erythematosus

A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321

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

The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.

NCT ID: NCT01299324 Completed - Clinical trials for Congestive Heart Failure

Retrograde Delivery of BMAC (Bone Marrow Aspirate Concentrate) for Congestive Heart Failure

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

The primary objective of this feasibility study is to provide clinical data to demonstrate the safety and activity of a concentrate of nucleated cells from bone marrow aspirate (BMAC) produced with the Harvest Bone Marrow Aspirate Concentrate System for treating patients diagnosed with congestive heart failure (CHF).

NCT ID: NCT01297504 Completed - Clinical trials for Respiratory Syncytial Virus Infection

A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America

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

The study was designed to gather information regarding the use of palivizumab for the prophylaxis for respiratory syncytial virus (RSV) infection in high-risk infants in selected countries within Latin America.

NCT ID: NCT01296958 Completed - Clinical trials for Taenia Solium Taeniasis

Targeted Screening for Taenia Solium Tapeworms

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

The purpose of this study is to determine whether screening and treatment of tapeworm carriers can decrease community transmission of Taenia solium parasitic infection.

NCT ID: NCT01295216 Terminated - Hypertension Clinical Trials

Use of Mobile Technology to Prevent Progression of Pre-hypertension in Latin American Urban Settings

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

Nearly half of the adult population in Latin American urban settings has abnormally high blood pressure. Although half of these subjects with high blood pressure are still in the pre-hypertensive stage (systolic blood pressure values in the 120-139 mmHg range or diastolic blood pressure in the 80-89 mmHg range), the rate of progression to hypertension is high (10-20% per year), according to studies done in other settings. The main objective of this proposal is to evaluate the effectiveness of an affordable and sustainable primary health care intervention to reduce blood pressure and prevent progression from pre-hypertensive status to hypertension in individuals at poor urban clinics in Argentina, Guatemala, and Peru. Our primary hypotheses are that pre-hypertensive subjects who receive mHealth (mobile health) support for 12 months (intervention group) will have lower blood pressure compared to individuals who receive the usual primary health care (control group); and that pre-hypertensive subjects will maintain lower blood pressure six months after receiving mHealth support. The investigators will determine the effects of an intervention using mHealth technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants. The intervention also aims to help participants become better informed, motivated, and encouraged to practice self-management of their own health; to improve patient satisfaction levels; provide tailored targeted interventions; and to improve patient-provider relationships. The proposal is designed as a proof-of-concept intervention in three Latin American countries that encompass a wide range of environments and health care settings. A total of 212 subjects (30-60 years old) per country will be recruited in primary health clinics and randomized to study groups. Blood pressure, anthropometry, and behavioral risk factors (physical activity, diet, stress, alcohol and tobacco use) will be measured at baseline and at months 6 and 12 during the intervention, and six months after the end of the intervention. The investigators will also evaluate feasibility, acceptability, cost-effectiveness, and process implementation of the intervention.

NCT ID: NCT01290887 Terminated - Eosinophilic Asthma Clinical Trials

Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma

Start date: June 2011
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed by adverse events, physical examination findings, vital sign measurements, and concomitant medication usage throughout the study (every 4 weeks), clinical laboratory test results, and measurement of antidrug antibodies.

NCT ID: NCT01287741 Terminated - Clinical trials for Diffuse Large B-Cell Lymphoma

A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)

Start date: July 26, 2011
Phase: Phase 3
Study type: Interventional

This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.

NCT ID: NCT01285609 Completed - Clinical trials for Lung Cancer - Non Small Cell Squamous

Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin

Start date: January 16, 2011
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.

NCT ID: NCT01285323 Completed - Eosinophilic Asthma Clinical Trials

A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma

Start date: March 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine whether reslizumab is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.