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NCT ID: NCT00140738 Completed - Neoplasms, Breast Clinical Trials

Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast Cancer

Start date: March 10, 2005
Phase: Phase 1
Study type: Interventional

Patients will receive a maximum of 18 injections of dHER2 vaccine in a treatment schedule that will last for up to about a year, and thereafter there will be a follow-up period of about one more year.

NCT ID: NCT00140673 Completed - Clinical trials for Infections, Rotavirus

A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.

Start date: August 5, 2003
Phase: Phase 3
Study type: Interventional

The main objectives of this study are: 1) In a subset (N = 20 000), to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age. 2) In all subjects (N = 60 000), to determine the safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.

NCT ID: NCT00140582 Completed - Follicular Lymphoma Clinical Trials

Primary Rituximab and Maintenance

Start date: December 2004
Phase: Phase 3
Study type: Interventional

- Objectives - Primary objective: To evaluate in patients with advanced follicular lymphoma the benefit of maintenance therapy with rituximab after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy - Secondary objective: To evaluate response rates, event driven survival endpoints (EFS, PFS, OS) and quality of life of four different chemotherapy regimens combined with rituximab, with or without maintenance with rituximab, for first line treatment of advanced stage follicular lymphoma. - Study Design This is an international open-label, multicentre, randomized study with two treatment phases. In the induction phase patients have to respond to 1st line induction treatment in order to be eligible for randomization to the second phase of maintenance treatment or observation. After the maintenance period patients will be included in the follow up phase for 3 years.

NCT ID: NCT00139776 Completed - Clinical trials for Osteoarthritis, Knee

Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"

Start date: July 2005
Phase: Phase 4
Study type: Interventional

To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.

NCT ID: NCT00139698 Completed - Clinical trials for Essential Hypertension

Olmesartan Alone or in Combination With Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension

OSCAR
Start date: September 2005
Phase: Phase 3
Study type: Interventional

Efficacy, tolerability and safety of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension

NCT ID: NCT00139594 Completed - Bipolar Disorder Clinical Trials

Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder

Start date: December 2004
Phase: Phase 4
Study type: Interventional

This extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.

NCT ID: NCT00139347 Completed - Clinical trials for Infections, Rotavirus

Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants

Start date: December 2003
Phase: Phase 3
Study type: Interventional

The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.

NCT ID: NCT00138437 Completed - Leprosy Clinical Trials

Molecular and Immunological Tools for Detection of Strain Diversity, Drug Resistance and Immunological Responses

Start date: April 2006
Phase: N/A
Study type: Observational

The purpose of this study is to determine what factors contribute to the continued incidence of leprosy in Colombia. Study participants will include volunteering and consenting individuals, older than 4 years of age, representing three study groups: 1. healthy persons with no known contact with leprosy patients 2. patients reporting at Instituto Colombiano de Medicina Tropical-CES and Impresa Social del Estado Sanatorio Agua de Dios with a new diagnosis of leprosy or relapse of leprosy 3. household contacts of leprosy patients described in group 2. Blood, nasal swabs, slit skin smears, and biopsies will be taken from the volunteers to learn the strains of leprosy-causing bacteria in the area, the immune responses (body's response to disease) in local residents against the bacteria, and the pattern of leprosy transmission. Individuals will participate in this study for 1-10 days, and the study will last for 3 years.

NCT ID: NCT00123916 Completed - Heart Disease Clinical Trials

BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas' Disease

BENEFIT
Start date: November 2004
Phase: Phase 3
Study type: Interventional

Evaluate if benznidazole, an antiparasite drug, given at a dose calculated as 5mg/kg/day for 60 days, now administered as a fixed daily dose of 300mg during 40 to 80 days of treatment - period adjusted according to the patient's body weight to a total minimum dose of 12g (corresponding to 40kg) and a total maximum dose of 24g (corresponding to 80kg) - reduces morbidity and mortality in patients with Chronic Chagas' Cardiomyopathy (CCC). The BENEFIT study is being conducted by the Population Health Research Institute (in Hamilton, Canada) and the Institute Dante Pazzanese de Cardiologia (Sao Paulo, Brazil) together with a Steering Committee, and an independent Safety Monitoring Board.

NCT ID: NCT00121862 Completed - Clinical trials for Cutaneous Leishmaniasis

Study to Evaluate the Leish-111f + MPL-SE Vaccine in Healthy Adults Not Previously Exposed to Leishmania Parasite

Start date: August 2005
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and immunogenicity of the Leish-111f + MPL-SE vaccine in adult subjects who have no evidence of previous exposure to the Leishmania parasite.