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NCT ID: NCT03287089 Completed - Clinical trials for Catheter-Associated Urinary Tract Infection

Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery

NAUTICA
Start date: September 29, 2017
Phase: Phase 4
Study type: Interventional

The specific aim of this randomized double-blind placebo-controlled trial is to evaluate the efficacy of administration of nitrofurantoin prophylaxis after catheter discontinuation for the prevention of catheter-associated urinary tract infections in patients with postoperative short-term catheterization following pelvic reconstructive surgery and/or urinary incontinence surgery. Patients that undergo pelvic organ prolapse and/or urinary incontinence surgery and fail their post-operative voiding trial will be included in the study. Upon successfully passing and in-office voiding trial at the time of catheter removal, they will be randomized to either nitrofurantoin 100mg twice daily or an identical appearing placebo capsule twice daily for 5 days following catheter removal. The primary outcome will be the treatment of clinically suspected and/or culture-proven UTI within 30 days of surgery. Secondary outcomes include adverse events associated with nitrofurantoin use and medication compliance. Primary and secondary outcomes will be evaluated with Student t test and chi squared or Fisher exact test as appropriate. Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 32% to 14%, with 80% power, and a two-sided alpha of 0.05, we should recruit a total of 164 patients.

NCT ID: NCT03283969 Completed - Obesity Clinical Trials

Influence of Freeze Dried Strawberry Consumption on Gut Microbiota and Cardiovascular Health.

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

This proposal seeks to build upon studies, including ours, on the favorable effects of California strawberries on vascular health. Freeze dried strawberry powder (FDSP) contains a number of nutrients that may have beneficial effects on plasma lipids and vascular function, as well as on the composition of the gut microbiota; changes in the gut microbiota can in turn have secondary positive effects on the vascular system as well as on other physiological functions that are important determinants of health and disease. The proposed project will seek to determine the influence of short-term FDSP intake on the gut microbiota composition, and select microbial-derived metabolites from stool, serum and urine, and their relationship to microvascular function. Secondary outcomes will include the influence of the FDSP on circulating levels of nitrate and nitrite and trimethylamine oxide (TMAO) as markers of vascular health that are influenced by both dietary intake and the oral and gut microflora, with blood pressure as an additional vascular outcome.

NCT ID: NCT03274466 Completed - Clinical trials for Postoperative Complications

Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty

PROMISES
Start date: December 5, 2017
Phase: N/A
Study type: Interventional

This study evaluates surgical site complications in subjects undergoing revision of a total knee arthroplasty when closed incision negative pressure therapy is used to manage the closed incision, as compared to a standard of care dressing.

NCT ID: NCT03261804 Completed - Vaginal Infection Clinical Trials

Relation Between Internal Vaginal Douching and Vaginal Infections in Intrauterine Contraceptive Device Users

Start date: June 1, 2018
Phase:
Study type: Observational

To determine the effect of performing internal vaginal douching on the frequency and severity and type of vaginal infections in IUD users

NCT ID: NCT03258502 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Learn About the Effects of Multiple Doses of Sisunatovir on People With Respiratory Syncytial Virus (RSV) Infection

Start date: July 19, 2017
Phase: Phase 2
Study type: Interventional

The purpose of the study is to learn about the safety, pharmacokinetics and antiviral activity of the study medicine (called sisunatovir/RV521) for the potential treatment of respiratory syncytial virus (RSV). Sisunatovir will be given as multiple doses during the treatment period. RSV is a highly contagious virus that can lead to serious lung infections in patients with reduced ability to fight infection. Most vulnerable populations include babies, the elderly and patients that have received a bone marrow transplant. This study is seeking healthy participants who are: 1. Aged 18 to 45 years old and will agree to the use of highly effective methods of contraception. 2. with a body mass index (BMI) of 18.0 to 30.0 Kg/m2 This study will consist of 2 cohorts of 33 participants each. In both cohorts participants will be exposed to the challenge virus on study day 0. Cohort 1 will receive either 200 mg of sisunatovir or placebo (looks the same as sisunatovir but contains no active medicine) 2 times a day for 5 days. Cohort 2 will receive either 350 mg of sisunatovir or placebo 2 times a day for 5 days. Participants will start taking the study medicine upon confirmation of RSV infection (or evening of Day 5 if not positive to RSV). The study medicine will be administered 12 hours apart (or twice daily). Each participant will remain in the quarantine unit until discharge on Day 12.

NCT ID: NCT03244644 Completed - Clinical trials for Clostridium Difficile Infection (CDI)

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)

Start date: July 31, 2017
Phase: Phase 3
Study type: Interventional

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe Clostridioides difficile infection (CDI) resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded dose of RBX2660.

NCT ID: NCT03239899 Completed - HIV Infections Clinical Trials

PD-1 Inhibition to Determine CNS Reservoir of HIV-Infection

Start date: April 9, 2018
Phase: Phase 1
Study type: Interventional

Background: HIV affects millions of people. The disease may "hide" in the brain, even in people with well-controlled HIV without cancer. Then it may "wake up" and continue. The drug pembrolizumab uses the body's immune system to fight cells like cancer cells. It is approved to treat some cancers but not HIV. Researchers want to see if it is safe for HIV-positive people without cancer. This study is not for HIV treatment; only one dose of the drug will be used. Objective: To learn if the drug pembrolizumab, used to treat certain cancers, is safe for HIV-positive people. Eligibility: Adults ages 18 and older with HIV who are in another NIH protocol Design: Participants will be screened with: - Medical history - Physical and neurological exams - Blood tests - Lumbar puncture. The lower back will be numbed. A needle will remove fluid from between back bones. - FDG-PET/CT. A radioactive sugar will be injected in a thin plastic tube (catheter) inserted in an arm vein. Participants will rest for an hour, urinate, then lie in the scanner. A mask will hold the head still. - Leukapheresis. An optional procedure at baseline. White blood cells are removed from you using a serum cell separator machine Women who can become pregnant cannot take pembrolizumab. Men who take it must use 2 kinds of contraception. Participants will have up to 7 more visits, which repeat some screening tests. At 1 visit, participants will get one dose of pembrolizumab by catheter for 30 minutes. They will get allergy and pain medicines. At 2 visits, participants will have a brain MRI. They will get a contrast agent by catheter. They will lie in a metal cylinder that takes pictures for 1-2 hours. They will get earplugs for loud sounds.

NCT ID: NCT03230916 Completed - Clinical trials for Suspected or Documented Gram-negative Bacterial Infection

A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)

Start date: November 6, 2017
Phase: Phase 1
Study type: Interventional

This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single intravenous (IV) dose of MK-7655A (a fixed ratio combination of imipenem/cilastatin/relebactam), hereafter referred to as IMI/REL.

NCT ID: NCT03230838 Completed - Pyelonephritis Clinical Trials

MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)

Start date: April 26, 2018
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) compared with that of meropenem in pediatric participants with cUTI, including pyelonephritis.

NCT ID: NCT03226379 Completed - Clinical trials for Cryptococcal Meningitis

Driving Reduced AIDS-associated Meningo-encephalitis Mortality

DREAMM
Start date: April 23, 2016
Phase: N/A
Study type: Interventional

The DREAMM project is investigating whether the DREAMM interventions (1) Health system strengthening, 2) Co-designed education programs tailored to frontline healthcare workers, 3) Implementation of a diagnostic and treatment algorithm and, 4) Communities of practice in infectious diseases and laboratory capacity building) when combined reduce two week all-cause mortality of HIV-associated meningo-encephalitis in African LMICs.