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NCT ID: NCT02527460 Terminated - HIV Infections Clinical Trials

Anakinra, A Recombinant Human IL-1 Receptor Antagonist for Neuroinflammation in HIV-1 Infection

Start date: August 17, 2015
Phase: Phase 1
Study type: Interventional

Background: HIV can sometimes cause HIV-associated neurocognitive disorder, or HAND. HAND is HIV-associated neurocognitive disorder. It can affect memory, thinking, or concentration. It can cause mood changes. HAND may be caused by HIV hiding in the central nervous system then causing inflammation. Researchers want to see if a drug for inflammation (Anakinra) can help people with HIV. Objective: To see if a drug for inflammatory diseases is safe for people with HIV-infection on antiretroviral therapy. Eligibility: Adults 18-61 years old with HIV who are enrolled in another study. Design: Participants will be screened with medical history, physical exam, and blood and urine tests. Participants will have up to 15 study visits over 16 weeks. At study visit 1, participants will have: - Screening tests repeated. - Brain magnetic resonance imaging (MRI) scans. They will lie on a table that slides into a metal cylinder in a strong magnetic field. They will get a dye inserted by a thin plastic tube in a vein. - Lumbar puncture. The lower back will be numbed. A needle will collect fluid from between bones in the back. - Tests of memory, thinking, and attention. Participants may also fill out forms and do tasks. Participants will learn how to inject the study drug. Over 8 weeks, they will give themselves the study drug at home every day. They will do up to 3 injections at once. They will write down their injections and any side effects. Participants will have 5 weekly visits while taking the study drug. They will answer questions and have blood drawn. At weeks 8 and 16, they will have a visit that repeats visit 1.

NCT ID: NCT02504099 Terminated - Clinical trials for Chronic Hepatitis C Infection

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma

GEODE - I
Start date: July 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or genotype 4 chronic HCV infection and treated early stage Hepatocellular Carcinoma with compensated cirrhosis.

NCT ID: NCT02474706 Terminated - Clinical trials for Urinary Tract Infections

Evaluation of the Non-inferiority of Cefoxitin Versus Imipenem/Cilastatin in the Treatment of Urinary Tract Infections Caused by ESBL-producing Escherichia Coli

COLIFOX
Start date: March 2016
Phase: Phase 4
Study type: Interventional

Background Information: Infections caused by extended-spectrum β-lactamase (ESBL)-producing Escherichia coli are becoming increasingly common owing to incorrect use of antibiotics and cross-transmission in healthcare establishments. These give rise to major problems in standard clinical practice: penicillins and cephalosporins cannot be used, and resistance to the other classes of antibiotics normally used, such as fluoroquinolones or cotrimoxazole, is very frequently observed. The current therapeutic strategy involves the use of a carbapenem, which represents the last effective solution on an individual level. However, the growing use thereof is contributing, collectively, to the development of resistance due to the production of carbapenemases, which will become a major public health problem, with a potential therapeutic dead-end. This observation is particularly worrying due to the very small number of antibiotic agents currently in development. Infectious disease specialists and microbiologists are thus examining alternative agents to carbapenems in the management of infections caused by ESBL-producing E. coli. One of the avenues which could be developed is the use of known agents, already on the market, which are active in vitro on ESBL-producing E. coli, but which are not currently recommended for this indication in standard practice due to the lack of conclusive studies. Cefoxitin, an antibiotic belonging to the cephamycin group, could thus represent an alternative of particular interest in the treatment of infections caused by ESBL-producing E. coli, and help limit the use of carbapenems. The implementation of a prospective, randomized, non-inferiority study on ertapenem and cefoxitin is of the most interest from a methodological perspective. It will enable recommendations to be drawn up, with a high level of evidence, very long-awaited in the field. Primary objective: To evaluate the bacteriological non-inferiority of cefoxitin versus imipenem in the treatment of non-severe urinary tract infections (other than cystitis) caused by ESBL-producing E. coli susceptible in vitro to cefoxitin. Secondary objectives: - To evaluate the clinical non-inferiority of cefoxitin versus imipenem in the treatment of non-severe urinary tract infections (other than cystitis) caused by ESBL-producing E. coli susceptible in vitro to cefoxitin. - To evaluate the impact of cefoxitin and imipenem on the emergence of multiresistant bacteria in the gut flora.

NCT ID: NCT02469311 Terminated - Osteoarthritis Clinical Trials

Prospective, Randomized Study Evaluating The Efficacy of Chlorhexidine Gluconate Impregnated No-Rinse Cloths.

SAGE
Start date: March 2012
Phase: Phase 2
Study type: Interventional

Subjects in the study were randomized to a treatment group using Chlorhexidine cloths or a standard-of-care group who only had a bath with antibacterial soap and water. Both groups received standard infection control practices during admission.

NCT ID: NCT02463669 Terminated - Splenomegaly Clinical Trials

The Use of Point-of-Care Ultrasound in the Diagnosis of Acute Infectious Mononucleosis in the Emergency Department

Start date: April 2016
Phase:
Study type: Observational

The purpose of this study is to determine if splenomegaly on point-of-care ultrasound (POCUS) is an accurate and user-friendly surrogate to the heterophile antibody test and Epstein-Barr Virus (EBV) serologies to diagnose acute mononucleosis infection in patients presenting with sore throat to the Emergency Department (ED).

NCT ID: NCT02460016 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

A Study of AK0529 in Infants Hospitalized With RSV

Start date: August 28, 2015
Phase: Phase 1
Study type: Interventional

This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single dose of AK0529 in infants hospitalized with respiratory syncytial virus (RSV).

NCT ID: NCT02392689 Terminated - Heart Failure Clinical Trials

Improve Management of Heart Failure With Procalcitonin

IMPACT-EU
Start date: March 2015
Phase: N/A
Study type: Interventional

Patients presenting to the Emergency Department with shortness of breath and (suspected) heart failure will be screened and randomized to either a standard of care or a procalcitonin-guided arm. Procalcitonin-guided arm: a procalcitonin level (cutoff 0.2 ng/ml) will be used to support decision on antibiotic therapy initiation. Standard of care arm: the decision on antibiotic therapy will be based on the physicians intent to treat. The patients will be followed up 30 and 90 days after randomization to evaluate the survival status, re-hospitalizations and further antibiotic therapies.

NCT ID: NCT02374853 Terminated - INFECTION Clinical Trials

Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)

SWI
Start date: March 2015
Phase: Phase 2
Study type: Interventional

The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection.

NCT ID: NCT02371538 Terminated - Clinical trials for Norovirus Infections

Human Breastmilk in Young Children With Norovirus Infection of the Gut

Start date: October 2014
Phase: N/A
Study type: Interventional

Human Breast milk in young children with Norovirus Infection

NCT ID: NCT02354144 Terminated - Clinical trials for Human Papillomavirus Infection

Lubricant Investigation in Men to Inhibit Transmission of HPV Infection

LIMIT-HPV
Start date: February 2016
Phase: Phase 2/Phase 3
Study type: Interventional

The LIMIT-Study is a placebo-controlled, double-blinded randomized controlled trial designed to explore the efficacy of a carrageenan-based lubricant as a topical microbicide for preventing HPV acquisition. Individuals at high risk for infection (men who have sex with men, or MSM, and especially those with HIV) will be included in the trial. Participants will complete a self-administered baseline questionnaire during the enrollment visit, and follow-up questionnaires during all other six visits. The shorter follow-up questionnaires are intended to evaluate recent sexual behaviours and to corroborate the responses given during the baseline visit. These questionnaires will measure HPV risk factors, compliance, and monitor safety and tolerability of the gels. Between follow-up visits, participants will be asked to log into a secure web module at least once a week to answer questions on daily sexual activities, condom and study gel use, and adverse events. Individuals will be screened for eligibility over the telephone or in person and eligible men will attend an enrollment visit, where the nurse will obtain informed consent and instruct the participant on gel use. They will receive a one month's supply of gel and provide the first specimen. Random number sets will be assigned to the treatment and control gel. Each participant will be assigned an individual code, which will be used to match him to the study arm. Lastly, the nurse will provide details about HPV infection and advice about condom use and sexual health. HPV infection status will be measured using anal specimens at baseline (enrollment/time 0), and at all follow-up clinic visits (1, 2, 3, 6, 9 and 12 months).