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NCT ID: NCT04252690 Completed - Lymphedema of Leg Clinical Trials

Physiological Study to Assess Mechanism of Action of MOBIDERM® in Lower-limb Lymphedema Patients

ACTIODERM
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

MOBIDERM® demonstrated his interest through clinical studies on the treatment of lower or upper limb lymphedema (Mestre et al 2017; Quéré et al. 2014). This CE (Conformity European)-marking device is well established both in ambulatory and hospitalisation. Nevertheless, the mechanism of action of this device had never been confirmed and no experimental clinical studies had been performed. The hypothesis is that the MOBIDERM system creates a pressure differential between the contact zone underneath the foam cubes composing the system and their surrounding area, leading to a shear effect on the subcutaneous tissues treated. The aim of this study is thus to assess the mechanism of action of MOBIDERM on the lymphatic system by evaluating quantitative and qualitative effects of this medical device on lymphatic system, oedema volume and cutaneous parameters in 10 lymphoedema patients during their hospitalisation for reduction phase.

NCT ID: NCT04252404 Completed - Acute Heart Failure Clinical Trials

FranceLEVO - Zimino Registry (FZR)

FZR
Start date: February 3, 2020
Phase:
Study type: Observational

The French National Authority for Health (Haute Autorité de santé) requested a registry study to obtain post-market surveillance data to describe baseline clinical profiles, management and outcome of patients treated with Zimino®. This study is designed to provide real-life data on the use, safety and clinical outcomes of Zimino® in routine clinical practice in France.

NCT ID: NCT04251949 Completed - Oral Cancer Clinical Trials

Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis.

MuciLight
Start date: March 19, 2021
Phase: Phase 2
Study type: Interventional

This is a monocentric, prospective, non-comparative phase II study with minimal risks and constraints. The study will aim to assess the curative treatment of radio-induced mucositis by photobiomodulation using LED lamp.

NCT ID: NCT04251637 Completed - Surgery Clinical Trials

Non Invasive Cardiac Output Evaluation With Starling SV for Lung Elective Surgery

NICOLE
Start date: September 25, 2020
Phase:
Study type: Observational

Intraoperative hemodynamic optimization decreases postoperative complications and length of stay in high risk patient. Therefore, continuous monitoring of cardiac output (Qc) is recommended to guide fluid management. Thoracic bio-reactance is a recent technique that allows cardiac output non-invasive monitoring. However, additional clinical validation studies in humans are required to better define the typologies of patients for whom this monitoring could be proposed routinely. Lung surgery is defined as an intermediate or high risk surgery regarding postoperative cardiac complications. However, surgical patients rarely benefit from continuous monitoring of cardiac output, the available methods being considered too invasive or insufficiently reliable in daily practice. Thoracic bio-reactance (Non Invasive Cardiac Output Monitor (NICOM) Starling SV) has not been studied in this subgroup of clinically relevant patients.

NCT ID: NCT04251013 Completed - Biliary Stricture Clinical Trials

Multicenter RCT for BIliary Brushing: RX Cytology, BOSTON vs. Infinity®, US Endoscopy

BIB
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

The aim of this prospective national multicenter randomized study is to compare, during an ERCP for VBP stenosis, the sensitivity of two biliary brushes: the INFINITY® vs the RX Cytology Brush® The main objective is the comparison of the rates of positive diagnosis of biliary brushing in cases of adenocarcinoma stenosis The total number of subjects required: 50 (25 patients per group) Duration of the inclusion period: 2 years Duration of participation for each subject: from 7 days to 12 months (in case of negative initial withdrawal) Total duration of the study: 3 years

NCT ID: NCT04250714 Completed - Atrial Fibrillation Clinical Trials

POLARx Cardiac Cryoablation System Study

POLAR ICE
Start date: August 6, 2020
Phase:
Study type: Observational

This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.

NCT ID: NCT04250532 Completed - Drowning Clinical Trials

Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN.

POSEIDON
Start date: June 26, 2020
Phase:
Study type: Observational

Drowning is the 3rd leading cause of accidental death in the world. One of the tools used by lifeguards to help ER assess gravity, is pulse oximetry. Its measure is variable even in optimal condition and its accuracy can be altered by factors specific to the patient and by environmental factors. The conditions gathered during a drowning rescue are thus propitious to a misleading evaluation. Assessing its reliability and looking for influencing factors of the measure of pulse oximetry could help for pre-hospital care management.

NCT ID: NCT04250389 Completed - Clinical trials for Acute Circulatory Failure

Microcirculatory Effects of Methylene Blue

MAGIC BLUE
Start date: January 1, 2017
Phase:
Study type: Observational

International guidelines recommend Methylene Blue (MB) as a second-line drug in the treatment of norepinephrine refractory vasoplegic shock (VS) after Cardiopulmonary Bypass CPB. Macrocirculatory effects of MB in this setting are now well established but microcirculatory effects of MB remain unknown. The purpose of this study is to assess the micro vascular effects of a single administration of methylene blue (1.5 mg/kg over 30 minutes) for norepinephrine-refractory VS post CPB. Microcirculatory effect will be monitored before and one hour after MB infusion through cutaneous refill time, video microscopy measurements of the sublingual microcirculation and tissue oxygen saturation combined with vascular occlusion test (VOT).

NCT ID: NCT04249466 Completed - Cystic Fibrosis Clinical Trials

Diet, Physical Activity and Glucose Tolerance in Cystic Fibrosis. Exploratory Study.

MONA
Start date: June 5, 2020
Phase:
Study type: Observational

Background : Diabetes is correlated to an increase in patient morbidity and mortality. The pathophysiology of diabetes is still poorly understood. Significant variations in blood sugar have been shown over time in patients with cystic fibrosis with or without diabetes. No study has evaluated the association between the nutritional profile and the glucose tolerance in adult with cystic fibrosis, by integrating data on energy consumption (detailed nutritional profile) and energy expenditure (rest energy expenditure, body composition, and physical activity). Given the epidemiological changes in cystic fibrosis correlated to the increased prevalence of diabetes and the clinical impact of nutritional status, the association between these factors remains to be studied. Objectives of the study : - Main objective : To describe adult patients with cystic fibrosis in terms of : - Nutritional profile - Food behaviour - Physical activity - Rest energy expenditure - Body composition - Secondary objectives : To research the association between the nutritional profile and the glucose tolerance.

NCT ID: NCT04249362 Completed - Clinical trials for Non-small Cell Lung Cancer

Study of Durvalumab Following Radiation Therapy in Patients With Stage 3 Unresectable NSCLC Ineligible for Chemotherapy

DUART
Start date: November 26, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase II open-label, single-arm, multicenter, international study to evaluate the clinical activity of durvalumab in patients with Stage III unresectable NSCLC who are deemed to be ineligible for chemotherapy per Investigator assessment. Patients will be enrolled into 2 cohorts according to radiotherapy pretreatment dose (Cohort A: standard radiation therapy [60 gray (Gy) ± 10% or hypofractionated bioequivalent dose (BED)]; Cohort B: palliative radiation therapy [40 to < 54 Gy or hypofractionated BED])