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NCT ID: NCT04138238 Completed - Clinical trials for Coronary Artery Disease

Cruz HBR Registry - Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz Stent

Start date: February 19, 2020
Phase:
Study type: Observational [Patient Registry]

This is a prospective, multicenter, open-label, single-arm registry. The primary objective of this registry is to confirm the results of the Supraflex Cruz stent in real life all-comer patients (800 patients as in the Supraflex arm of the TALENT trial) and demonstrate that the Supraflex Cruz stent is not inferior to the BioFreedom stent in High Bleeding Risk (HBR) patients (400 patients) with respect to device oriented composite endpoint (DOCE) at 12 months. All patients will be followed up to 12 months after the index procedure.

NCT ID: NCT04137510 Completed - Clinical trials for Coronary Artery Disease

Bioflow-DAPT Study

Start date: February 24, 2020
Phase: Phase 4
Study type: Interventional

BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study. A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro Mission or Resolute Onyx. After index procedure, all patients will receive DAPT (ASA + P2Y12 inhibitor) for 30 days, followed by monotherapy with either P2Y12 inhibitor or ASA only until the end of the study. Clinical follow-up visits will be scheduled at 1, 6 and 12 months post-procedure.

NCT ID: NCT04137484 Completed - Knee Arthropathy Clinical Trials

Patient Blood Management Program in Total Hip or Total Knee Arthroplasty

Start date: July 1, 2014
Phase:
Study type: Observational

Total hip and knee arthroplasty are among the most common surgical procedures for which blood transfusion is prescribed. Patient blood management program has been proposed to decrease the need for transfusion. This program involve three pillars: preoperative improvement of erythropoiesis, intraoperative reduction of bleeding and postoperative management of anemia. Among the different steps of this program, reduction of bleeding and optimization of anemia are gaining popularity, but preoperative improvement of erythropoiesis is underused. The preoperative step of the blood management program is not systematically used because it requires a complex organization, is considered expensive, and finally because the others available techniques to reduce blood transfusion are easier to implement. The aim of this study was to assess, within a patient blood management program, the effectiveness of erythropoietin on reducing allogenic blood transfusion and anemia in patients requiring elective total hip or knee arthroplasty. "

NCT ID: NCT04137471 Completed - Mood Disorders Clinical Trials

Validation of the Ontological Addiction Scale

OAS
Start date: November 1, 2019
Phase:
Study type: Observational

Background: Bypassing a reductionist view of existing diagnostic categories, ontological addiction theory (OAT) is a new psychological model of human functioning and mental illness. Ontological addiction is a maladaptive condition that stems from an erroneous belief in an inherently existing Self or "I", which is deemed to be the root of all suffering. Five experts from four different countries have created the Ontological Addiction Scale (OAS) to measure the condition and its impact on people's lives. The purpose of this study is to test this scale, evaluating levels of ontological addiction in individuals suffering from emotional or mood disorder, and assess its psychometric properties. Methods: This trial will be conducted in compliance with the COSMIN Guidelines. The investigators will collect data from 400 individuals, aged 18 to 70, suffering from emotional or mood disorder, referred to the Therapeutic Center for Mood and Emotional Disorders for an 8-week-mindfulness-based-intervention. Patients will complete the OAS at three time points: one month before the beginning of the therapy, within one week prior to the beginning of therapy, and one year after the end of the therapy. This scale will be completed in conjunction with other practice assessments relating to the psychotherapeutic program. The psychometric properties of the OAS will be assessed. Discussion: The Investigators aim to validate a scale assessing a psychological dimension as the root of all mental disorders. The present study may contribute to overcoming limitations of categorical understanding of mental disorders, thus moving toward a more encompassing dimensional comprehension. The scale is responsive to current thinking in modern psychiatry, and it is envisaged that its validation will deeply impact research and care perspectives

NCT ID: NCT04137302 Completed - Clinical trials for Anti-doping Campaign, Detection of Hydrocortisone

Administration of Hydrocortisone in Young Healthy Male Volunteers

H-CORT
Start date: November 13, 2019
Phase: Phase 4
Study type: Interventional

The misuse of cortisone or hydrocortisone for doping purpose in sport has been widely reported in the literature, but to date, no formal testing procedure is available and applicable in an anti-doping laboratory to detect hydrocortisone doping abuse , i.e., administration by systemic way. The investigators therefore propose to identify biomarkers that clearly distinguish between an authorized local administration of hydrocortisone and a prohibited systemic administration, by studying the impact of 5-day administration of hydrocortisone per 2 different routes.

NCT ID: NCT04137289 Completed - Cholangiocarcinoma Clinical Trials

A Study to Find a Safe and Effective Dose of BI 905711 in Patients With Advanced Gastrointestinal Cancer

Start date: March 11, 2020
Phase: Phase 1
Study type: Interventional

Phase Ia - Explore safety and establish the maximum tolerated dose (MTD)/recommended dose levels for phase Ib expansion phase of BI 905711 based on the frequency of patients experiencing dose limiting toxicities (DLTs) during the MTD evaluation period. The MTD evaluation period is defined as the first two treatment cycles (from first dose administration until the day preceding the third dose administration or end of REP in case of discontinuation before start of Cycle 3). Phase Ia - Explore pharmacokinetics/pharmacodynamics, and efficacy to guide the determination of a potentially effective dose range for phase Ib in the absence of MTD. Phase Ib - Evaluate efficacy and safety of BI 905711 at a potentially effective dose range and determine the Recommended Phase 2 Dose (RP2D)

NCT ID: NCT04136925 Completed - Intensive Sport Clinical Trials

Evaluation of the Preparation of Runners and the Impact of an Ultra-trail Event in a Hot and Humid Environment

ERUPTION1
Start date: October 11, 2019
Phase:
Study type: Observational

Human beings are characterized by their extraordinary ability to thermoregulate. During a physical exercise, only 25% of the energy provided by the substrates is converted into muscular mechanical work. The remaining 75% is released as heat. In fact, thermoregulation has always been an integral part of exercise's physiology. Due to current climate change, study and understand the mechanisms of thermoregulation and the practices of runners to cope with these constraints becomes increasingly necessary in order to optimize the sports performance and protect the health of athletes of all levels. Heat stroke is responsible for more deaths than any other environmental disaster and is the second leading cause of sport mortality after heart problems. The exercise-related hyperthermia and malignant hyperthermia, dehydration and hyponatremia problems have been relatively well studied in several sports. For ultra endurance disciplines, the data remains very fragmentary.

NCT ID: NCT04136899 Completed - Clinical trials for Cross-Sectional Studies

Burn Out and Quality of Life at French General Practioners

Start date: August 20, 2019
Phase:
Study type: Observational

The suffering of caregivers is constantly increasing. General medicine, because of its primary role in primary care, is particularly exposed to the risk of burn-out and must protect itself. The aim of this study was to find an inverse relationship between health-related quality of life and being severely burned by French general practitioners.

NCT ID: NCT04136574 Completed - Hand Dermatoses Clinical Trials

Hand Dermatitis in the Care and Hospital Staff

MANUS-PRO
Start date: July 1, 2019
Phase:
Study type: Observational

Study of the prevalence and risk factors of occupational dermatitis in the hands of caregivers and hospital staff of the Brest CHRU.

NCT ID: NCT04136184 Completed - Clinical trials for Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

NEURO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

Start date: January 15, 2020
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of eplontersen after administration for 65 weeks to patients with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN), as compared to the NEURO-TTR trial (NCT01737398). For more information, please visit http://www.neuro-ttransform.com/.