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NCT ID: NCT03231943 Completed - HIV Infections Clinical Trials

GSK3640254 First Time in Human (FTIH) Study in Healthy Volunteers

Start date: September 19, 2017
Phase: Phase 1
Study type: Interventional

Human immuno deficiency virus 1 (HIV-1) infections continues to be a serious health threat throughout the world and development of medicines with new mechanism of action have an important role to play. GSK3640254 is a maturation inhibitor (MI) and can be effective in HIV-1 treatment. This randomized, 2-part, single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of in healthy subjects for GSK3640254. The information collected in this study will help in further clinical development of GSK3640254, including a Phase IIA Proof of Concept (PoC) study in HIV-infected subjects. Approximately 16 healthy subjects will be randomized to receive single oral dose of GSK3640254 and placebo in Part 1 and approximately 56 healthy subjects will be randomized to receive repeat oral dose of GSK3640254 or placebo in Part 2. All doses will be given immediately after a moderate fat meal. Maximum duration of study participation will be approximately 12 weeks.

NCT ID: NCT03229824 Completed - Breast Cancer Clinical Trials

Use of Clorhexidine Dressings to Reduce Surgical Site Infections in Breast Cancer Surgery. A Controlled Clinical Trial

Start date: October 3, 2016
Phase: N/A
Study type: Interventional

Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of sick woman could delay the adjuvant therapy and result increase morbidity and mortality. Also this increased costs associated with health care.Surgical drains have been noted as a potential source for surgical site infections. The primary aim of the study is to determine if chlorhexidine occlusive dressings applied to the intervention drain sites effectively decreases rates of bacterial colonization in drain fluid and drain tips compared to standard care.

NCT ID: NCT03228108 Completed - Prostate Cancer Clinical Trials

Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy.

pro-SWAP
Start date: April 3, 2018
Phase: Phase 4
Study type: Interventional

This study aims to assess the effectiveness and cost-effectiveness of rectal swab culture-guided antimicrobial prophylaxis to reduce infectious complications after transrectal prostate biopsy. Half of participants will receive routine empirical prophylaxis with oral ciprofloxacin (control group), while the other half will receive rectal culture-guided oral antibiotic prophylaxis (intervention group). In the intervention group, men whose rectal swabs do not show ciprofloxacin-resistant bacteria will receive ciprofloxacin prophylaxis, comparable to the control group. In case of ciprofloxacin-resistant bacteria an alternative oral antibiotic based on the culture results will be prescribed (trimethoprim/sulfamethoxazole, fosfomycin or pivmecillinam/augmentin). The investigators hypothesise that the targeted prophylaxis group (intervention group) will have a lower rate of post-biopsy infectious complications compared to the control group.

NCT ID: NCT03228095 Enrolling by invitation - Colorectal Cancer Clinical Trials

Volatiles in Breath and Headspace Analysis - Diagnostic Markers

Volatolome
Start date: July 24, 2017
Phase:
Study type: Observational

Detection of Volatile Organic Compounds (VOC) directly from tissue by headspace analysis (skin, surgery material, other tissue) and exhaled breath is feasible using affordable user-friendly novel nano-chemo sensors that can accurately be used for screening and monitoring purpose

NCT ID: NCT03226626 Not yet recruiting - Sepsis Clinical Trials

Tumescent Anesthesia Antibiotic Delivery (TAAD)

TAAD
Start date: December 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This is a multicenter randomized clinical trial (RCT) comparing two modes of antibiotic delivery: Control: Intravenous Antibiotic Delivery (IVAD) Treatment: IVAD + TAAD The Food & Drug Administration (FDA) has approved our Investigational New Drug (IND) application to conduct this RCT. An IND application was necessary because subcutaneous injection of antibiotics in general, and cefazolin and metronidazole in particular are considered to be "off-label". In addition, the tumescent formulation of cefazolin (1gm) and metronidazole (500mg/100ml) in a dilute solution of lidocaine (1gm), epinephrine (1mg) in 100ml and sodium bicarbonate (10mEq/10ml) added a 1000ml bag of 0.9% sodium chloride (total volume 1210ml) is also considered "off-label." This trial will also prospectively study the HK Surgical SubQKath, an over-the-needle subcutaneous catheter specifically designed to deliver relatively large volumes of a relatively dilute TAAD solution. The TAAD trial will document the safety and efficacy of the HK SubQKath

NCT ID: NCT03226119 Completed - HTLV-I Infections Clinical Trials

MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

Start date: January 15, 2018
Phase: Phase 4
Study type: Interventional

This post-market study is intended to assess the performance of the HTLV Blot 2.4 in repository serum/plasma specimens with neurological disorders (n=100) or an HTLV known positive infection (n=50).

NCT ID: NCT03225079 Terminated - Clinical trials for Severe Bacterial Infection

PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring

PERFORM
Start date: November 8, 2017
Phase:
Study type: Observational [Patient Registry]

International registry on the use of Pentaglobin® in patients with severe bacterial infections; multicentric, international registry, non-interventional trial

NCT ID: NCT03223415 Completed - Clinical trials for Clostridium Difficile

Effectiveness of Isolating Clostridium Difficile Asymptomatic Carriers on the Incidence of Infections

EFFICACI
Start date: August 25, 2017
Phase: N/A
Study type: Interventional

Background: There is an urgent need to develop new strategies to prevent Clostridium difficile infections (CDI). A recent study suggests that a novel infection control bundle (IC bundle) can lead to a significant decrease in the incidence of CDI in acute-care hospitals. This IC bundle consists in screening patients for C. difficile carriage upon their admission combined with implementation of isolation precautions for carriers. Further investigations are required to confirm these findings. Objective: To evaluate the feasibility of implementing a multicenter interventional study to further to investigate the efficacy of this IC bundle. Methods: Prospective, cluster randomized feasibility trial of 2 infection control strategies (a "standard" and an "experimental" strategy) to reduce transmission of C. difficile among patients in 20 medical wards in 5 acute-care facilities in Quebec. Wards will be randomized (1:1) to one of the 2 interventions. Each intervention will be applied to all patients present on selected wards. The study will be divided into (1) a 3-month baseline period; (2) a 2-week randomization and implementation period; and (3) an 8-week intervention period. Intervention: The "experimental strategy" includes the components of the above-mentioned IC bundle. The "standard strategy" will not implement the IC bundle. Outcomes: As a feasibility study, process evaluation will form the primary and secondary outcomes. These outcomes will allow to determine whether a future main trial is possible and desirable. Hypothesis: We hypothesize that the intervention will be implementable across the study wards. Significance: This study is essential to plan a subsequent definitive trial to determine whether the IC bundle can prevent CDI.

NCT ID: NCT03223402 Completed - HIV Infections Clinical Trials

Nevirapine + 3TC Based Maintenance Therapy for HIV Infection

NVP+3TC
Start date: December 23, 2016
Phase: N/A
Study type: Interventional

Type of study: Investigator initiated clinical study Study design: One arm, open label, pilot study (n=10) Research question Is treatment with Nevirapine + 3TC sufficient for HIV maintenance Risk Category B (no investigational drugs, non standard Tx) Therapies with 2 drugs are often done in HIV-maintenance. This is a systematical evaluation of such a two drug trial. Rescue therapy is well defined within the protocol. Centers (n) St. Gallen only Participants 10 HIV Patients already on nevirapine + 2 non-nuke RT-Inhibitors Study duration 24 weeks primary observation period after study termination, patients may opt to continue on the bi-therapy. Clinical follow up will then continue Sponsor/Investigator Pietro Vernazza, Kantonsspital St. Gallen Principal investigator Pietro Vernazza, MD. Kantonsspital St. Gallen Co-Investigators Patrick Schmid, MD, Matthias Hoffmann, MD Financial source None (Pilot Study) If study demonstrates good results, an SNF grant proposal will be submitted

NCT ID: NCT03223233 Completed - Wound Infection Clinical Trials

Predicting the Severity of Post-cesarean Wound Infections Using Serum Procalcitonin Levels

Start date: May 2, 2017
Phase: N/A
Study type: Observational [Patient Registry]

The serum procalcitonin levels are important during infections and sepsis. The investigators aimed to assess its predictive value in terms of post-cesarean wound infection.