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NCT ID: NCT02578706 Completed - HIV-1 Infection Clinical Trials

Targeting Platelets in Chronic HIV Infection

Start date: October 2015
Phase: Phase 2
Study type: Interventional

Advances in antiretroviral therapy (ART) have resulted in increased survival of the HIV-infected population; however, this gain in longevity is associated with an increased risk of cardiovascular disease (CVD). Although ART and traditional risk factors contribute to CVD in this population, heightened markers of immune activation, inflammation, and coagulation independently predict morbidity and mortality, suggesting that dysregulation of these systems plays a significant role in the increased risk of CVD. The investigators believe that platelet activation is an important driver in HIV-associated immune activation, inflammation, and coagulation, leading to an increased CVD pathophysiology and risk. Platelets initiate thrombus formation and also play a key role in vascular inflammation by releasing pro-inflammatory mediators and cross-talking with other relevant cell types including leukocytes. Researchers have described platelet hyperreactivity in chronic HIV infection. Importantly, the investigators demonstrated that one week of anti-platelet therapy (aspirin) decreased platelet activation and immune activation, with an improved trend in inflammation and immune parameters. The overall hypothesis is that platelet activation is a major driver of immune activation, inflammation, and thrombosis in ART-treated HIV infected patients. The purpose of the proposed proof-of-concept study is to understand the mechanism(s) by which anti-platelet therapy improves immune and inflammatory parameters in chronic HIV infection. To test this, the immune modulating and anti-inflammatory effects of 24 weeks of the anti-platelet drug aspirin as compared to the anti-platelet drug clopidogrel will be evaluated. Given their different mechanisms of action and inhibitory potency, the investigators can differentiate whether the potential benefits are mediated via inhibition of arachidonic acid (aspirin) or inhibition of ADP (clopidogrel) or by the antithrombotic activity. A secondary goal is to perform multidimensional assays of platelet activity and thrombogenicity alongside immune activation assays and careful assessments of traditional risk factors and medication regimens, to understand which parameters are highly associated with thrombogenicity.

NCT ID: NCT02577718 Completed - Clinical trials for Catheter-Related Infections

Safety and Effectiveness of Novel Nitroglycerin Based Catheter Lock Solution

Start date: November 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this Phase I/II pilot study is to evaluate the safety and effectiveness of a non- antibiotic chelator based lock solution that contains nitroglycerin in combination with sodium citrate and ethanol (NiCE lock solution) for prevention of central line associated bloodstream infection (CLABSI). - The primary objective of this study is to evaluate the safety and estimate the rate of adverse events associated with the NiCE lock solution. - The second primary objective is to estimate the rate of CLABSI in patients receiving the NiCE lock solution.

NCT ID: NCT02576314 Completed - Clinical trials for Chronic Hepatitis C Infection

Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients

Start date: May 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotype 3 infection.

NCT ID: NCT02576236 Recruiting - Clinical trials for H Pylori Eradication

Therapeutic Trial Comparing Triple Therapy Guided by the PCR Detection of Clarithromycin Resistance vs Empiric Concomitant Quadruple Therapy for Helicobacter Pylori Infection

Hepysé
Start date: May 2016
Phase: N/A
Study type: Interventional

The H pylori infection remains a public health problem. The eradication rate with the first line triple therapy (PPI-amoxicillin-clarithromycin) is insufficient (estimated at 70%) due to the frequency of resistance to clarithromycin, which reaches 21% in France. Until now,European and French consensus recomended tofavor sequential therapy (5 days PPI-amoxicillin and 5 days PPI-clarithromycin-metronidazole) or quadruple bismuth therapy ( 10 days PPI-tetracyclin,-metronidazole- bismuth). Studies in countries with low prevalence of clarithromycin resistance reported eradication rate of 85% with sequential therapy and reported a low impact of clarithromycin resistance on the effectiveness of this treatment. However, recent studies suggest a greater impact of clarithromycin resistance. Recent meta-analysis shows that empiric sequential therapy is less efficacious than concomitant quadruple therapy. Therefore, recent Maastricht V / Florence meeting October 7-8 2015) recommended to abandon sequential therapy and to favor 14 days concomitant therapy in first line in order to reach an eradication rate >90%. In a multicenter randomized clinical trial (HELICOSTIC 2010-2011 AO ICST 2009), we compared a triple therapy guided by the results of a PCR test that detects resistance to clarithromycin and levofloxacin (HelicoDR ®) to empirical triple therapy (PPI-amoxicillin-clarithromycin). 1384 patients and among them 526 infected patients were enrolled in 10 centers. The results in 415 patients were 73.1% for the empirical treatment versus 85.5% (p <0.001) for the treatment guided by PCR HelicoDR®. This study also demonstrated the limits of the test HelicoDR®: onerous, possibility of contamination, little practical contribution of the determination of resistance to quinolones. Moreover, it has been shown that triple therapy efficiency could be optimized by increasing duration up to 14 days and increasing dose of PPI to 40mg b.d;.and eradications rates > 90% were reported with susceptible to clarithromycin strains. Adverse events are less common with optimized triple therapy than with concomitant quadruple therapy. The main objective is to compare the efficacy of optimized triple therapy guided by the results of a PCR test (eradication rates 90% hypothesized) with quadruple concomitant therapy (eradication rate 90% hypothesized). The secondary objective is to determine side effects of optimized guided triple therapy as well as the quadruple concomitant therapy in France.

NCT ID: NCT02575079 Completed - Clinical trials for Bone Marrow Transplant

Parafilm to Prevent CLABSI in Pediatric Patients Undergoing HCT

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

The purpose of this study is to see if applying parafilm as an external barrier on the central line in children having a bone marrow transplant helps to prevent central line associated bloodstream infection(s) and also to assess the ease of use of parafilm.

NCT ID: NCT02574702 Completed - Clinical trials for Surgical Wound Infection

Trial to Reduce Wound Infection With Contralateral Drainage in Loop Ileostomy Closure

Start date: February 2013
Phase: N/A
Study type: Interventional

1. Introduction: The most common complication of loop ileostomies closure for rectal cancer patients undergoing a low anterior rectum resection, is the superficial surgical site infection (incidence 2-40%). There are various techniques related to closing loop ileostomy. In a retrospective study at our center, the investigators objectify that superficial surgical site infection rate was reduced by more than a half by the application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure. 2. Objectives and Hypothesis: Hypothesis: The application of a contralateral drainage (Penrose ®) in primary loop ileostomy closure (in carriers of loop ileostomy by a low anterior rectum resection for rectal cancer) reduces the superficial surgical site infection. Main objective: To reduce the rate of superficial surgical site infection by the application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure. 3. Methodology: Prospective and randomized clinical trial on the effectiveness of contralateral Penrose® drainage implementation in those patients that have a primary loop ileostomy (by low anterior rectum resection) closure to be able to know if the investigators can reduce the superficial surgical site infection rate. Monitorization until 30 days after surgery

NCT ID: NCT02572895 Recruiting - Clinical trials for Urinary Tract Infections

Cranberry Extract and Urinary Infection Prevention: a Clinical Trial

PACCANN
Start date: August 2015
Phase: Phase 1
Study type: Interventional

The purpose of this clinical trial study is to assess, among young and sexually active women presenting recurrent urinary tract infection (UTIs), efficacy of an optimal dose of cranberry extract quantified and standardized to 37 mg/day of Proanthocyanidins (PACs), compared to a control dose quantified and standardized to 2 mg/day of PACs on mean number of new UTIs during a 6-month follow-up period.

NCT ID: NCT02571374 Recruiting - Colorectal Cancer Clinical Trials

Symbiotics to Prevent Postoperative Infection in Colorectal Cancer

Start date: October 2013
Phase: N/A
Study type: Interventional

This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be selected to receive either a symbiotic formulation or placebo. The researchers will compare incidence of surgical site infection between the study groups.

NCT ID: NCT02570490 Completed - Clinical trials for Acute Bacterial Skin and Skin Structure Infections

Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Start date: November 2015
Phase: Phase 3
Study type: Interventional

Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects with ABSSSI

NCT ID: NCT02570321 Recruiting - Corneal Ulcer Clinical Trials

Cross-linking for Corneal Ulcers Treatment Trial

CLAIR
Start date: November 2015
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to determine if patients randomized to corneal collagen cross-linking plus medical therapy will have a lower prevalence of positive bacterial or fungal cultures immediately after the procedure than patients who received medical therapy alone. The secondary purpose of this study is to determine if patients randomized to corneal collagen cross-linking will have a better visual acuity at 3 and 12 months than patients who receive medical therapy alone.