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NCT ID: NCT00242840 Completed - HIV Infection Clinical Trials

Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)

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

This study will assess the efficacy of subsequent protease inhibitor (PI)-containing therapy in subjects who have acquired HIV-1 protease mutations whilst receiving a GW433908 (fosamprenavir)-containing regimen.

NCT ID: NCT00240461 Completed - Clinical trials for Respiratory Tract Infection

Use of COLD-fX to Prevent Respiratory Infections in Community Dwelling Seniors

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

Seniors are a population vulnerable to respiratory infections. It is hypothesized that regular use of COLD-fX following an influenza vaccination would potentially augment immune response in the elderly. Use of COLD-fX may also provide additional protection again respiratory infection and reduce the incidence and severity of respiratory infections in otherwise healthy seniors.

NCT ID: NCT00239213 Completed - Influenza Infection Clinical Trials

Catechin Gargling for Influenza Infection

Start date: November 2005
Phase: N/A
Study type: Interventional

The purpose of this study is to clarify the preventive effects of catechin gargling on the influenza infection.

NCT ID: NCT00238459 Completed - HIV Infections Clinical Trials

Controlling Acute or Early HIV Infection With Antiretroviral Drugs, Without a Candidate Vaccine.As Reported Previously, the Candidate Vaccie Was Not Provided by the Maufacturer as Promised

Start date: July 2005
Phase: Phase 1
Study type: Observational

The purpose of this study is to determine the role of HIV-specific CD4 T cell responses and immune responses dependent upon these CD4 responses that develop when antiretroviral drugs are started during acute or recent HIV infection, whether these CD4 responses can be enhanced with a therapeutic HIV vaccine (HIV-1 immunogen), and what pattern of HIV-specific immune responses is associated with control of HIV upon discontinuation of antiretroviral drugs during an analytical therapeutic interruption. Participants will be treatment-naive adults with acute or early HIV infection who will choose to start or not start anti-HIV drugs at the beginning of the study. NOTE: In August 2007 we were notified by the manufacturer of the candidate vaccine that they were no longer making the vaccine, and that the vaccine would no longer be available. Unfortunately too few participants have received either the vaccine or placebo to conclude anything about efficacy. No safety problems occurred.

NCT ID: NCT00237055 Completed - Crohn's Disease Clinical Trials

Infectious Agents in Pediatric Crohn's

Start date: August 2004
Phase: N/A
Study type: Observational

Six sites of the Pediatric Inflammatory Bowel Disease Consortium (plus 2 additional sites) will participate in this study. The participating sites will be that of the Principal Investigator (PI), Emory University School of Medicine, Atlanta, GA (Benjamin D. Gold, MD); Texas Children's Hospital / Baylor College of Medicine (George Ferry, MD and Tony Olive, MD); Children's Hospital of Philadelphia, Philadelphia, PA (Bob Baldassano, MD); University of Chicago Children's Hospital, Chicago, IL (Barbara Kirschner, MD); University of California, San Francisco (Mel Heyman, MD); Mass General Hospital / Harvard University (Harland Winter, MD); V.A. Stanford University School of Medicine, Stanford, CA (David Relman, MD); Children's Center For Digestive Healthcare, Atlanta, GA (Stanley Cohen, MD); and Centers for Disease Control and Prevention, Atlanta, GA (Drs. Jeannette Guarner, Siobhan O'Connor and Thomas Shinnick) The duration of study is 2 yrs. Objectives: 1. Improve the methods to collect biopsies from the colon and ileum, tissue storage techniques and best methods to detect specific infections in children with Crohn's disease; 2. Determine if there are specific infectious agents that are more common in children with Crohn's disease, and; 3. Determine if there are types of children with Crohn's disease (e.g., children living in Boston, African American children) who may be more at risk for getting the infections. The study design involves children ages 6 months through 17 11/12 years of age who are undergoing a clinically-indicated colonoscopy. Subjects will be grouped into cases and controls. - Any child ages 6 mos through 17 11/12 years of age, undergoing a clinically-indicated colonoscopy as determined by the treating physician, is eligible for enrollment. About 500 patients will be enrolled in this study. - Cases will consist of those children within the defined age group, who are undergoing diagnostic colonoscopy and have the definitive diagnosis of Crohn's disease. - Children who have the diagnosis of indeterminate colitis or ulcerative colitis for the purpose of this R03, will be excluded as cases and from initial analysis, but will have tissue specimens banked for subsequent evaluation for infectious agents. - Controls will consists of children within the defined age group, undergoing clinically indicated colonoscopy and who are not diagnosed with Crohn's disease, ulcerative colitis or indeterminate colitis (e.g., juvenile polyps, irritable bowel syndrome or functional bowel disease). - Stool specimen (5ml/1 tsp) will be collected to test for different types of bacteria - A questionnaire will be administered to each research volunteer. - Each subject's medical information (i.e. diagnosis, disease stage, and laboratory results) will be stored electronically in a separate access-based database. A unique identifier will be assigned to each patient entered into the study and will also be used for blinding of the specimens analyzed by the pathologist and by molecular assays for infectious agents. - Colonoscopy will be performed by the treating pediatric gastroenterologist and biopsies obtained in the usual standard of care. - Clinical biopsies from the rectum, left, right, transverse colon and cecum will be placed in formalin containing vials as per standard of care for the clinical pathologist and diagnostic evaluation.

NCT ID: NCT00235456 Completed - Wound Infection Clinical Trials

Supplemental Oxygen Reduces Surgical Infection

Start date: March 2003
Phase: Phase 2/Phase 3
Study type: Interventional

Supplemental perioperative oxygen has been reported to halve or double the risk of surgical wound infection. We tested the hypothesis that supplemental oxygen reduces infection risk following colorectal surgery. Colorectal surgery patients (n=300) were randomly assigned to 30% or 80% FiO2 intraoperatively and 6 hours postoperatively. Wound infections were diagnosed by blinded investigators using Centers for Disease Control criteria. Baseline patient characteristics, anesthetic management, and potential confounding factors were recorded. Wound infection rates were compared with chi-square analysis. Logistic regression identified the contribution of potential confounding factors. Surgical wound infection occurred in 24.4% of patients receiving 30% oxygen, but only 14.9% of those receiving 80% oxygen (P<0.039). According to logistic regression, the relative risk of infection in patients given supplemental oxygen was 0.46 (P=0.035). Supplemental inspired oxygen reduced wound infection risk by roughly a factor of two. We thus recommend that supplemental oxygen be provided to patients undergoing colorectal surgery.

NCT ID: NCT00235040 Completed - Clinical trials for Respiratory Tract Infections

Evaluating the Effectiveness of the Acute Respiratory Infection Smart Form

Start date: November 2005
Phase: N/A
Study type: Interventional

To evaluate the effectiveness of the Acute Respiratory Infection Smart Form

NCT ID: NCT00234949 Completed - Clinical trials for Mild to Moderate Uncomplicated Skin and Skin Structure Infections

A Study to Compare Cefdinir and Cephalexin for the Treatment of Mild to Moderate Uncomplicated Skin Infections

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

The purpose of this study is to compare the efficacy and tolerability of cefdinir to that of cephalexin in patients with mild to moderate uncomplicated skin/skin structure infections.

NCT ID: NCT00233376 Completed - Cross Infection Clinical Trials

Computerized Decision Support System for Antibiotic Treatment

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

We developed a computerized decision support system for prescription of antibiotics to inpatients. The purpose of the study is to assess the performance of the system in different wards, in three different hospitals, in three countries.

NCT ID: NCT00232908 Completed - HIV Infections Clinical Trials

QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection

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

This study will evaluate patient quality of life and tolerability of a HAART (highly active antiretroviral therapy) regimen containing twice-daily subcutaneous injections of Fuzeon in clinically stable, treatment-experienced patients with HIV-1 infection. All patients will use a 31-gauge thin-walled 8mm needle to administer Fuzeon. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.