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NCT ID: NCT01011049 Completed - Influenza Clinical Trials

Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM

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

The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine. Primary Objective: - To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants. Secondary Objective: - To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.

NCT ID: NCT01009827 Completed - HIV Clinical Trials

Managerial Database II

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

This study will collect information on health status and risk behaviors, as well as basic demographic and biomedical information for a group of HIV positive adolescents receiving care at the ATN sites.

NCT ID: NCT01009749 Completed - HIV Clinical Trials

Motivational Enhancement System for Adherence

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

This is a two-phase study, consisting of the following plan: Phase I - This is a pre-test of the feasibility and acceptability of the beta version of a computer-delivered intervention, Motivational Enhancement System for Adherence (MESA), as well as the control intervention Motivational Enhancement System for Health (MESH) at three selected AMTUs. Following analysis of the responses in Phase I and further modification of the intervention, Phase II will be initiated. Phase II - This is a pilot, randomized, controlled trial (RCT) testing a two-session computer-delivered intervention, MESA, designed to increase motivation for adherence to Highly Active Antiretroviral Therapy (HAART) among youth newly recommended to begin medications, as well as an attention control, MESH, matched for dose and delivery format. Phase II is open to all 15 AMTUs.

NCT ID: NCT01008150 Completed - Breast Cancer Clinical Trials

Phase II Randomized Trial Evaluating Neoadjuvant Therapy With Neratinib and/or Trastuzumab Followed by Postoperative Trastuzumab in Women With Locally Advanced HER2-positive Breast Cancer

Start date: October 2010
Phase: Phase 2
Study type: Interventional

FB-7 is a Phase II, multi-center randomized study of neratinib in combination with weekly paclitaxel with or without trastuzumab followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for women with HER2-positive locally advanced breast cancer. Patients in the control arm will receive neoadjuvant trastuzumab in combination with weekly paclitaxel followed by AC. The primary aim of the study is to determine the pathologic complete response (pCR) rate in breast and axillary nodes following the neoadjuvant therapy regimens. The secondary aims include determination of the pCR rate in breast only, clinical complete response (cCR) rate, two-year recurrence-free interval, two-year overall survival, toxicity of the neoadjuvant regimens, and exploration of molecular and genetic correlates of response.

NCT ID: NCT01007435 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis

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

This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.

NCT ID: NCT01003990 Completed - HIV Clinical Trials

Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access

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

The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial

NCT ID: NCT01000805 Completed - Clinical trials for Major Depressive Disorder

A Study of Duloxetine in Major Depressive Disorder (MDD) and Associated Painful Symptoms

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

The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.

NCT ID: NCT01000753 Completed - Clinical trials for Mantle Cell Lymphoma

Collecting and Storing Tissue Samples From Patients With Rare or Cutaneous Non-Hodgkin Lymphoma

Start date: May 30, 2005
Phase:
Study type: Observational

This research study is collecting and storing tissue samples from patients with rare or cutaneous non-Hodgkin lymphoma. Collecting and storing samples of tissue from patients with cancer to test in the laboratory may help the study of cancer in the future.

NCT ID: NCT00993447 Completed - Dengue Clinical Trials

Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America

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

Primary objectives: - To describe the immune response to each dengue serotype before and after each vaccination with sanofi pasteur's CYD dengue vaccine. - To evaluate the safety of each vaccination with sanofi pasteur's CYD dengue vaccine.

NCT ID: NCT00992836 Completed - HIV Infections Clinical Trials

Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth

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

Children and people infected with HIV are particularly susceptible to influenza infections. This study testED the safety and effectiveness of a vaccine for the new H1N1 influenza virus in children and youth infected with HIV.