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NCT ID: NCT01085591 Completed - Diarrhea Clinical Trials

Study of CB-183,315 in Participants With Clostridium Difficile Infection

Start date: April 1, 2010
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, single-placebo, active-controlled, dose ranging parallel group design with 3 arms. Two dose regimens of CB-183,315 dosed twice daily will be compared with the active comparator oral vancomycin (125 milligrams (mg ) four times daily). Participants with diarrhea at risk for Clostridium difficile infection (CDI) [for example, received prior or concomitant antibiotic(s)] will be identified and tested for C. difficile toxin in stool using an enzyme immunoassay (EIA), or polymerase chain reaction (PCR) per the usual standard of care. Eligible participants will be consented, undergo baseline evaluations, and will be randomized in a blinded fashion to one of 3 treatment arms. Participants will be randomized to receive either 125 mg CB-183,315 twice daily alternating with placebo tablets twice daily, 250 mg CB-183,315 twice daily alternating with placebo tablets twice daily or 125 mg oral vancomycin four times dailyover a period of 10 days in a 1:1:1 fashion.

NCT ID: NCT01082692 Completed - HIV Infections Clinical Trials

Study of PENNVAX™-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants

HIV-001
Start date: January 2011
Phase: Phase 1
Study type: Interventional

DNA vaccines consist of small pieces of DNA also known as plasmids, and have several potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well tolerated in humans. We have developed DNA vaccine, PENNVAX-B, which includes plasmids targeting the gag, pol, and env proteins of HIV-1. The vaccine will be delivered via electroporation (EP) which uses the CELLECTRA constant current device to deliver a small electric charge following injection, since animal studies have shown that this delivery method increases the immune response to vaccine. The vaccine will be given to HIV-1 infected subjects whose viral load is undetectable on a HAART regimen, with CD4 lymphocyte count above 400 cells/µL of blood. It is hypothesized that PENNVAX-B + EP will be safe and well tolerated.

NCT ID: NCT01080989 Completed - Hypertension Clinical Trials

The Sero-Prevalence and Genetic Study for the Infectious Diseases and Metabolic Syndrome in Solomon Islands

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

The study project can be divided into two parts: (1) health screening for the community and (2) clinical diagnosis and treatment for patients at National Referral Hospital (NRH) in Solomon islands. The health screening includes a questionnaire, stool parasitic screening and blood laboratory tests. A total of 800 subjects will participate in this study. The collected samples are venous blood (20 ml/per subject) and stool in order to conduct the related tests mentioned above. As for the collection of target patients, KMUH will cooperate with NRH to collect two kinds of blood samples: the blood samples of confirmed malarial cases and those of cases suspicious of Flaviviral, Alpha-viral, Rickettsial, and Leptospiral infections. The expected received cases are 600 each year. The venous blood samples (20 ml/per subject) will be used to conduct related tests mentioned above. At the same time, the subjects will also have to fill out a related questionnaire which includes height, weight, waist line, heath behavior and habit, and past history, etc.

NCT ID: NCT01080963 Completed - Wound Infection Clinical Trials

Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections

DaPro
Start date: November 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to show that the incidence of sternal wound infections at day 30 after cardiac surgery is 50% lower with the additional use of Daptomycin on top of a standard antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone.

NCT ID: NCT01077765 Completed - HIV Infection Clinical Trials

Polyacrylamide Hydrogel Injection in HIV-related Lipoatrophy

LIPOPHILL
Start date: November 2005
Phase: Phase 3
Study type: Interventional

Combined antiretroviral therapy (cART) is associated with facial lipoatrophy, which is potentially stigmatizing for HIV-positive patients. Eutrophill is a 2.5% polyacrylamide hydrogel obtained by polymerization of acrylamide monomers with an official half-life of 5 years. Preliminary encouraging results with the use of polyacrylamide hydrogel for reconstruction of facial lipoatrophy in HIV-infected patients have been previously reported. The primary objective of the study was to evaluate the long-term efficacy and safety of subcutaneous facial injections of Eutrophill in HIV-infected patients with severe facial lipoatrophy as assessed by facial ultrasonography at screening , after 6, 12 and 24 months

NCT ID: NCT01077557 Completed - Fracture Clinical Trials

Fractures Stratified by HIV and Antiretroviral Therapy (ART) Status

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

This US population-based study will explore the incidence of and risks for fracture among adults with and without human immunodeficiency virus (HIV) infection. The objectives are to determine the incidence of fracture among persons with and without HIV infection, compare risk factors for fracture among persons with and without HIV infection, and to examine the associations of antiretroviral (ARV) treatment exposure for incidence and risk of fracture among persons with HIV infection.

NCT ID: NCT01076166 Completed - Clinical trials for Lower Respiratory Tract Infection

Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension.

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

Klacid Granules for Oral Suspension provides short symptoms' recovery time in Thai children with lower respiratory tract infections.

NCT ID: NCT01076153 Completed - Clinical trials for Respiratory Tract Infection

Recovery Time in Thai Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR

Start date: December 2008
Phase: N/A
Study type: Observational

The investigators hypothesize that Klacid modified release (MR) shortens symptom recovery time in Thai patients with upper or lower respiratory tract infections.

NCT ID: NCT01075984 Completed - Fungal Infection Clinical Trials

Pharmacokinetics, Safety, and Tolerability of Intravenous Posaconazole Solution Followed by Oral Posaconazole Suspension in Subjects at High Risk for Invasive Fungal Infections (P05520)

Start date: February 23, 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to collect pharmacokinetic (PK) information related to how well intravenous Posaconazole (POS IV), is distributed in the body and to determine the safety and tolerability of this new formulation. In addition, the PK, safety, and tolerability of switching from taking POS IV to taking Posaconazole Oral Suspension (POS Oral) will be evaluated. The data collected in this study will be compared to data collected in previous studies. Individuals who have been diagnosed by their physicians with a blood disease or cancer that can affect their infection-fighting white blood cells will be asked to participate in the trial. Since these blood diseases and their treatments can weaken the immune system, they may put these individuals at a high risk for getting a serious fungal infection of their internal organs or blood (invasive fungal infection). As these fungal infections can be hard to detect early and can be life-threatening, many physicians believe that individuals diagnosed with these diseases should receive antifungal therapy to try to lower their risk of getting this type of infection. Enrollment into this study will take place in several stages (cohorts). The determination of which cohort an individual will be asked to participate in is based on which cohort is open at the site at the time the individual is approached to consider study participation.

NCT ID: NCT01074775 Completed - Clinical trials for Bacterial Infections

Human Innate Immune Responses To Mycobacterial Aerodigestive Tract Infection

UBC-INNATE01
Start date: September 2006
Phase: N/A
Study type: Interventional

The approach we will use is to employ measurement of the activation of white blood cells, to look at patterns of responses during a controlled infection of the gut with Mycobacterium bovis. M. bovis can be conveniently obtained in a safe and pure form as an oral vaccine. By giving three challenges of M bovis to the gut, we will simulate repeated gut infections with this organism. We can then compare the activation of cells in the blood to the immune responses seen after each challenge, to determine whether the non-specific defences of the gut can block each subsequent infection.