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NCT ID: NCT03560193 Completed - Clinical trials for Cardiac Surgery in Adult Patient

Randomized Trial of 2% Chlorhexidine-70% Isopropanol vs 5% Povidone Iodine-69% Ethanol for Skin Antisepsis in Reducing Surgical-site Infection After Cardiac Surgery

CLEAN2
Start date: September 10, 2018
Phase: Phase 4
Study type: Interventional

Despite completion of more than 9 million procedures each year in France, the best antiseptic solution to be used for preparing the skin to reduce risk of surgical site infection (SSI) remains unknown. 2% Chlorhexidine gluconate (CHG)-alcohol is superior to Povidone Iodine (PVI)-alcohol for short term vascular catheter care (Mimoz O, Lancet 2015; Pages J, Intensive Care Med 2016), but studies comparing both antiseptic solutions for clean-contaminated surgical procedures led to conflicting results. The present study will be the first large scale multicenter randomized controlled trial adequately powered to compare efficacy and safety of CHG-alcohol over PVI-alcohol in reducing SSI after clean surgery. A clean surgery was chosen because pathogens involved in SSI mostly originate from skin. Therefore, optimisation of skin disinfection before surgery has the potential to reduce the incidence of SSI. Cardiac surgery was chosen because SSI may be severe, diagnosis of SSI is easy to monitor and to define and infections arise earlier than other frequent clean surgeries using implants such as orthopaedic or vascular surgery. The incidence of reoperation for any purpose will be used as the main objective because there are easy to track and define and are less susceptible to interpretation in an open trial than superficial SSI. According to CDC criteria, patients will be monitored up to Day 90 because mediastinitis after cardiac surgery may occur after the usual 30-day SSI surveillance period.

NCT ID: NCT03559998 Completed - Clinical trials for Undergraduate Medical Students' Learning Process in Doctor-patient Relationship Training

Learning Process of Fourth Year Medical Students During a Doctor-patient Relationship Training

APTHERA
Start date: June 2, 2018
Phase:
Study type: Observational

This study aims to explore learning process for undergraduate students in this doctor-patient relationship course. This study is one of the 3 studies included in a PhD on learning process during simulation training in psychiatry. The results of this 3 studies will aim at building a formative and summative assessment tool of competences specific to this pedagogic context.

NCT ID: NCT03559699 Completed - Clinical trials for Pyruvate Kinase Deficiency

A Study Evaluating the Efficacy and Safety of AG-348 in Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)

Start date: June 26, 2018
Phase: Phase 3
Study type: Interventional

Study AG348-C-007 was a multicenter study designed to evaluate the efficacy and safety of treatment with AG-348 in a minimum of 20, with up to 40, participants with pyruvate kinase (PK) deficiency, who were regularly receiving blood transfusions. The study was composed of two parts. During Part 1, Dose Optimization Period, participants started on a dose of 5 mg AG-348 administered twice daily. Over the course of Part 1 each participant's dose of AG-348 was sequentially increased to 20 mg twice a day, followed by 50 mg twice a day depending on their tolerance. During Part 2, Fixed-Dose Period, participants received AG-348 at their optimized dose from Part 1.

NCT ID: NCT03559283 Completed - D020521 Clinical Trials

fNIRS in the Evaluation of Cognitive-motor Interference in Post-stroke Patients

ICM-AVC
Start date: November 26, 2018
Phase: N/A
Study type: Interventional

This study evaluates cognitive-motor interference in stroke patients who is responsible an alteration of spatio-temporal gait parameters. It's proved in the literature but the underlying pathophysiological mechanisms remain poorly understood. fNIRS is a functional imaging technique that evaluates this interference under optimal conditions. The purpose of this study is to evaluate the hemodynamic activity of the CPF in walking post-stroke patients under different DT conditions.

NCT ID: NCT03559257 Completed - Migraine Clinical Trials

A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine

CONQUER
Start date: July 31, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.

NCT ID: NCT03559062 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis

Start date: May 17, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the F508del mutation (F/F) or heterozygous for F508del with an eligible residual function mutation (F/RF).

NCT ID: NCT03558789 Completed - Metallic Taste Clinical Trials

Metallic Taste Before, During and After Treatment of Head and Neck Cancer

TORCAD
Start date: April 26, 2018
Phase:
Study type: Observational

Metallic taste in head and neck cancer is widely under-estimated in the literature. Its causes are multiple and poorly defined. Though it has a strong impact on the nutritional status. The main objective of the TORCAD project is to test the hypothesis that intraoral lipoperoxidation is associated to metallic taste onset before, during and after treatment of head and neck cancer (HNC). The secondary goals are to evaluate the involvement of others physiopathological factors in metallic taste: (i) additional chemical modification in the saliva; (ii) release of inhibition of the facial nerve on the glossopharyngeal nerve; presence of an intraoral electric current; food pleasantness and acceptability; quality of life.

NCT ID: NCT03558646 Completed - Clinical trials for Smoke Inhalation Patients

Impact of Hydroxocobalamine on Outcome of Smoke Inhalation Injury Admitted to the ICU

COB-AKI
Start date: June 1, 2017
Phase:
Study type: Observational

In Europe, hydroxocobalamin (cyanokit) has been used for suspicion of cyanide intoxication associated with the inhalation of fire smoke (1). However, the impact of hydroxocobalamin on outcome has never been thoroughly evaluated. While hydroxocobalamin has long been presented as being side-effect free, recent data suggest that in patients with severe burns, its use was associated with the occurrence of acute renal failure by intra tubular precipitation of oxalate crystals (2, 3). The purpose of this observational study is to investigate the association between use of hydroxocobalamin and outcome after smoke inhalation.

NCT ID: NCT03558490 Completed - Breast Cancer Clinical Trials

A Study to Assess the Feasibility of an E-Health System (ZEMY) Designed to Manage Symptoms in Participants With Breast Cancer Under Anti-Cancer Treatment

ZEMY
Start date: June 12, 2018
Phase: Phase 2
Study type: Interventional

This is a three-month open-label, multicenter, interventional, single arm study located in France, designed to assess feasibility and reliability of the e-Health ZEMY software medical device under investigation for use by participants with breast cancer, who are starting an anti-cancer treatment at any stage of the disease, to manage disease symptoms and anti-cancer treatment-related toxicities while at home.

NCT ID: NCT03557671 Completed - Cow Milk Allergy Clinical Trials

Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins

Start date: August 23, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to show the hypoallergenicity of a new thickened rice based formula (TRHF) through a double blind placebo controlled food challenge (DBPCFC), as recommended by the American Academy of Pediatrics, in subjects with IgE-mediated CMA and in subjects with non-IgE-mediated CMA.