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NCT ID: NCT01611402 Completed - Tuberculosis Clinical Trials

Gene Expression in HIV and Tuberculosis Co-infection

Start date: May 29, 2012
Phase:
Study type: Observational

Background: - Tuberculosis (TB) infection is particularly deadly when it happens in people who are also infected with the human immunodeficiency virus (HIV). However, not much is known about how these two infections affect each other. Some people who have HIV or TB infections develop health problems after they start taking either HIV or TB medications or both. These drugs can improve the body s ability to fight infections, but sometimes this sudden improvement can make the infected person initially become sicker. Researchers want to study how these infections affect the immune system and the gene expression of people who have TB and may or may not have HIV, to see if there is a pattern of gene expression that may predict whether people starting treatment may get sicker initially. Objectives: - To study the gene expression and immune systems of people with TB who may or may not also have HIV. Eligibility: - Adults at least 18 years of age who have tuberculosis. - Participants will be drawn from study sites in the United States and China. Design: - Participants will be divided into three study groups. The first group will have TB but not HIV. The second group will have both TB and HIV that have not been treated. The third group will have both TB and HIV that are currently being treated. - All participants will have a single study visit. Blood samples will be collected at this visit. A medical history will also be collected. - No treatment will be provided as part of this study.

NCT ID: NCT01610271 Completed - Clinical trials for Surgical Site Infection

Air Barrier System for the Prevention of Surgical Site Infection

ABS
Start date: January 2012
Phase: N/A
Study type: Interventional

Airborne particles are present in all indoor environments including the operating room. Most of these particles come from the surgical staff moving around in the room, positioning of the patient during surgery, and the movement of surgical equipment and supplies. While the amount of particulate in an operating room is much, much less than is found in a typical home or public space, some particulate is usually present no matter how the room and air are cleaned and filtered. Typically these few particulate cause no problems, but the goal is always to have the cleanest air possible during surgery. The Air Barrier System (ABS) consists of a reusable blower and a sterile nozzle. The blower feeds filtered air into the sterile disposable nozzle, which disperses a constant stream of gentle, high purity air over the surgical incision. This stream of air forms a shield over the surgical area to prevent airborne particulate from settling into the open wound. This is particularly critical for long-duration surgeries, such as procedures that involve the implantation of a prosthesis. The main objective of this research study is to determine whether the ABS can reduce the potential for surgical site infection during total hip replacement, spinal fusion, or lower extremity bypass grafting procedures. These procedures were chosen because each is a long-duration procedure which involves implantation of prosthesis.

NCT ID: NCT01608815 Completed - Clinical trials for Bacterial Infections

Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects

Start date: May 2012
Phase: Phase 3
Study type: Interventional

This study is designed to assess the immunogenicity and safety of typhoid Vi polysaccharide vaccine in Japanese participants to support registration of the product in Japan. Primary Objective: To describe the seroconversion rate (percentage of subjects with at least a 4-fold increase of their Vi antibody titer) between Day 0 before vaccination and Day 28 after vaccination with typhoid Vi polysaccharide (SP093) vaccine in subjects aged 2 years and above. Secondary Objectives: - To describe the safety profile of a single dose of typhoid Vi polysaccharide vaccine up to 28 days after vaccination, in subjects aged 2 years and above. - To describe the immune response following a single dose of typhoid Vi polysaccharide vaccine in subjects aged 2 years and above.

NCT ID: NCT01608685 Completed - Clinical trials for Latent Tuberculosis Infection

Interferon Gamma Release Assays (IGRA) Testing Versus Tuberculin Skin Test in Renal Transplant Recipients

Start date: January 2010
Phase: N/A
Study type: Observational

Interferon gamma release assays (IGRA) have been shown to be more specific and sensitive for the detection of tuberculosis (latent or active infection) than the tuberculin skin test (TST) in immunocompetent individuals. However, very little data are available concerning the relative performance of IGRA and TST in immunosuppressed individuals from other causes than HIV. The investigators hypothesize that IGRAs would be more sensitive and specific than the TST in a group of renal transplant recipients under chronic immunosuppressive treatment for detecting latent tuberculosis infection.

NCT ID: NCT01602614 Completed - Clinical trials for Cytomegalovirus Infections

Evaluation of the Pharmacokinetics (PK) and Pharmacodymamics (PD) of Ganciclovir (GCV) in Premature Infants Receiving Treatment for Cytomegalorivus (CMV) Infection

Start date: April 2013
Phase:
Study type: Observational

This is a clinical sampling study, and no study drugs will be administered under this protocol. Premature infants who receive intravenous ganciclovir as part of clinical care will be eligible for participation in this study. Intravenous ganciclovir will not be provided under this protocol.

NCT ID: NCT01601041 Completed - Clinical trials for Urinary Tract Infection

Role of Residual Urine and Asymptomatic Prostatitis in the Development of Urinary Tract Infections in Spinal Cord Injury

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

The purpose of this prospective study is to investigate the association between the amount of residual urine and asymptomatic bacterial prostate infection with the occurrence of recurrent (>2 /year) symptomatic urinary tract infections in patients suffering from chronic (> 1 year) spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction performing intermittent catheterization. The following hypotheses will be tested: 1. The amount of residual urine after intermittent catheterization is significantly greater in SCI patients suffering from frequent (>2 /year) urinary tract infections compared to those without. 2. The incidence of asymptomatic bacterial prostate infections is significantly higher in SCI patients suffering from frequent (>2 /year) urinary tract infections compared to those without.

NCT ID: NCT01599806 Completed - Clinical trials for Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis

Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

Start date: October 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis

NCT ID: NCT01599416 Completed - Clinical trials for Human Papillomavirus

Influence of U-relax on Vaginal Health Promotion and HPV DNA Test Change From Positive to Negative

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

The purpose of this study is to understand the effect of using oral U-relax on HPV infected women for vaginal environment health promotion, and the HPV DNA Test Index change from positive to negative. Long-term infection of HPV is associated with cervical cancer. U-relax contains Lactobacillus GR-1 and Lactobacillus RC-14 and has been approved of its benefits on treatment of BV, UTI, IBD and can improve vaginal environment health. Patients with positive result of HPV DNA test have no appropriate and aggressive treatment to reduce the risk of cervical cancer. This clinical trial tries to reveal the influence of oral U-relax and patients with HPV DNA test positive result.

NCT ID: NCT01597687 Completed - Pertussis Clinical Trials

Pertussis Infection in Adolescents and Adults With Prolonged Cough

Start date: June 20, 2012
Phase: N/A
Study type: Interventional

This study aims to determine the burden of pertussis infection among adolescents and adults with prolonged cough in four Asian countries, namely Malaysia, Philippines, Taiwan and Thailand. This study also aims to assess the health economic (HE) impact of pertussis.

NCT ID: NCT01595529 Completed - Clinical trials for Urinary Tract Infection

The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"

Start date: May 18, 2012
Phase: Phase 2
Study type: Interventional

The SCOUT study is a multi-center, centrally randomized, double-blind, placebo-controlled non-inferiority clinical trial. 746 participants will be enrolled over a 4.5 year period. 672 will be evaluated for the study's primary outcome measure. After the first 5 days of primary care physician initiated antimicrobial therapy, patients who are afebrile and asymptomatic will then be randomized (1:1) to the standard course therapy arm of 5 more days of the same antibiotic therapy or the short course therapy arm of a placebo for 5 more days (for 10 days total). The primary objective of this study is to determine if halting antimicrobial therapy in subjects who have exhibited clinical improvement 5 days after starting antibiotic therapy (short course therapy) have the same failure rate (symptomatic UTI) through visit Day 11-14 as subjects who continue to take antibiotics for an additional 5 days (standard course therapy).