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NCT ID: NCT01290679 Completed - Hepatitis C Clinical Trials

An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants

QUEST-2
Start date: March 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.

NCT ID: NCT01289782 Completed - Hepatitis C Clinical Trials

An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients

QUEST-1
Start date: February 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alpha-2a and ribavirin as part of their treatment.

NCT ID: NCT01289015 Completed - Tinea Pedis Clinical Trials

Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

NAFT-600
Start date: February 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of NAFT-600, applied once daily for 2 weeks, when compared to placebo for 2 weeks in the treatment of subjects with tinea pedis.

NCT ID: NCT01286012 Completed - Clinical trials for End Stage Renal Disease

Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients

PRIME
Start date: January 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the clinical safety and efficacy of SFP in sparing the need for erythropoiesis stimulating agents (ESAs) required to maintain hemoglobin (hgb) levels in chronic hemodialysis subjects who receive SFP via the dialysate versus subjects who receive conventional dialysate without iron.

NCT ID: NCT01284556 Completed - Epilepsy Clinical Trials

Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures

Start date: November 2010
Phase: Phase 3
Study type: Interventional

Primary: - to evaluate the efficacy of phenobarbital in reducing seizure frequency. Secondary: - to confirm dose response relationship, - to assess the effects on Type I seizures, - to assess the safety of phenobarbital - to assess the drug tolerability.

NCT ID: NCT01283360 Completed - HIV Negative Clinical Trials

Microbicide Safety and Acceptability in Young Men

Project Gel
Start date: October 2010
Phase: Phase 1
Study type: Interventional

After completing a screening evaluation, 280 eligible participants, including 40 sex workers, will be enrolled into Stage 1A of the study during which they will undergo a baseline medical evaluation for both history and presence of STIs and anorectal health pathologies or injuries, as well as a detailed Web-based baseline behavioral assessment. The first 140 eligible participants, including 20 sex workers, reporting at least one occasion of unprotected RAI in the previous 3 months will be invited to enroll into Stage 1B. In Stage 1B participants will apply the universal placebo gel (HEC) rectally prior to each episode of RAI over a 3-month period, reporting each use via a phone reporting system; they will complete a Web-based questionnaire and take part in a video teleconference at the end of the 3 months. The first 24 eligible participants completing Stage 1B will be invited to enroll in Stage 2. The subset of sex workers who took part in Stages 1A and 1B will terminate participation at the end of 1B. Eligible participants will be randomized to receive either tenofovir 1% gel or HEC placebo gel as part of Stage 2, the Phase 1 safety study. Following a baseline visit, participants will return to the clinic, where a single dose of the study gel will be administered. Within approximately 30 minutes, rectal swab and rectal biopsy specimens will be obtained via anoscopy. After a one-week recovery period participants will return to the clinic for assessment. If no significant adverse events (AEs) are reported they will begin to self-administer once-daily outpatient doses of the study gel for 7 days, after which they will return to the clinic for evaluation and specimen collection.

NCT ID: NCT01283009 Completed - Clinical trials for Community Acquired Respiratory Disease Syndrome

Extended Steroid in Use in Community Acquired Pneumonia (CAP)(e)

ESCAPe
Start date: January 9, 2012
Phase: Phase 3
Study type: Interventional

The goal of the study is to determine whether providing early treatment with a glucocorticoid drug, called methylprednisolone, will improve survival in critically ill patients with severe community-acquired pneumonia (CAP). Pneumonia develops when bacteria and other agents invade the lungs. The body's immune system creates a response to produce inflammation to kill the bacteria. A moderate amount of inflammation is beneficial. But, in patients sick enough to be admitted to the ICU, inflammation is frequently out of control. When the body cannot regulate inflammation vital organs (brain, heart, lung, kidney, liver) may be damaged, contributing to death or residual organ damage for those who survive. Glucocorticoids help reduce inflammation. Recent studies have shown that when the body is unable to produce sufficient amounts of glucocorticoids, inflammation can get out of control. Under these circumstances, glucocorticoids given in small doses may help aid the body's ability to reduce inflammation and improve recovery. In a small preliminary trial, glucocorticoid treatment, in addition to standard antibiotic treatment, sped up recovery from pneumonia. It also decreased the length of hospital stay, and increased survival. This Cooperative Studies Program (CSP) study will be the first large-scale, prospective, randomized clinical trial evaluating whether or not this treatment improves recovery. In this study, at each site, patients with severe CAP will be assigned to one of two treatment groups. One group will receive methylprednisolone and the other will receive a placebo (an inert substance that will look like the drug). The investigators have chosen a total duration of treatment of 20 days (7 days full dose followed by slow reduction over 13 days) to prevent relapse of inflammation and allow the body to recover its own ability to produce glucocorticoid. All patients will also receive standardized management of CAP in accordance with current practice guidelines. The study will take into consideration when assigning the treatment each participating site, and whether or not the patient requires mechanical ventilation at the time of assignment. Patients will be followed clinically for 180 days. The primary outcome is all cause 60-day mortality. Secondary outcomes are (1) in-hospital morbidity-mortality, including ventilator-free days, multiorgan dysfunction syndrome (MODS)-free days, duration of ICU and hospital stay, and hospital discharge; and (2) posthospital discharge morbidity-mortality, including cardiovascular complications, functional and general health status in the first 180 days, rehospitalization, and mortality at 1 year. Serial blood samples will also be collected and stored for future translational research relating longitudinal inflammation markers to clinical outcomes. This study will advance knowledge on the relationship between inflammation and long-term outcome in severe CAP.

NCT ID: NCT01281839 Completed - Hepatitis C Clinical Trials

An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy

PROMISE
Start date: February 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy. Patients will also receive peginterferon alfa-2a and ribavirin as part of their treatment.

NCT ID: NCT01272232 Completed - Obesity Clinical Trials

Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALEā„¢ - Diabetes

Start date: June 1, 2011
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the potential of liraglutide to induce and maintain weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added onto subject's pre-trial background diabetes treatment of either diet and exercise only or single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea [SU] or glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The duration of the trial will be 56 weeks followed by a 12 week observational follow-up period.

NCT ID: NCT01266902 Completed - HIV-1 Infection Clinical Trials

A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1

Start date: February 2011
Phase: Phase 3
Study type: Interventional

The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.