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NCT ID: NCT04605978 Completed - Clinical trials for Primary Sjögren's Syndrome

Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients

Start date: August 3, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the effect of multiple intravenous infusions of S95011 compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.

NCT ID: NCT04605172 Completed - Premature Birth Clinical Trials

Lockdown Impact on Spontaneous Premature Birth in a Level III NICU

CONFINéo
Start date: November 2, 2020
Phase:
Study type: Observational

Preterm labor (PL) is the leading cause of hospitalization during pregnancy and premature birth the leading cause of fetal morbidity and mortality in France. PL is defined by regular and painful uterine contractions associated with a change in the cervix, between 22 and 36 weeks of gestation. It has been shown that the risk of spontaneous prematurity increases particularly in case of working over 40 hours per week, hard physically conditions, or prolonged daily transport time. Rest is one of the most efficient measure to prevent PL and should be proposed to all pregnant women, and combined with other therapies such as tocolysis or cerclage when needed. The very particular period of lockdown during the COVID-19 pandemic had pregnant women to drastically reduce their activity. They suspended their work and stayed home for various reasons such as pregnancy in progress, children at home, and also collective reasons such as teleworking or workplace closure. During the lockdown period from March 17th to May 11th 2020, fewer preterm labor and less spontaneous prematurity have been suspected by the neonatology and obstetrics teams throughout the Lorraine region. Our study aims to objectively confirm this observation. In this investigation we aim to find a relationship between lockdown, PL and spontaneous prematurity which would need to re-evaluate public health recommendations for pregnant women outside the lockdown.

NCT ID: NCT04603755 Completed - Clinical trials for Acute Respiratory Distress Syndrome

Electrical Impedance Tomography: Collapse in Dependent Areas as a Predictor of Response to Prone Position Ventilation in COVID-19 Acute Respiratory Distress Syndrome

COVIDEIT
Start date: October 26, 2020
Phase:
Study type: Observational

There are several clinical presentations of SARS-CoV-2 infection. Among the severe forms, pulmonary involvement with respiratory failure is common. Although severe lung involvement with SARS-CoV-2 meets the Berlin criteria for Acute Respiratory Distress Syndrome (ARDS), it differs from classic ARDS in that compliance (reflecting distensibility of the lung parenchyma) is frequently preserved. If the interest of Electrical Impedance Tomography has been demonstrated in classical ARDS, this is not the case in ARDS with COVID-19. However, the use of this technique in this particular patient population would make it possible to distinguish patients with severe hypoxemia linked to derecruitment from those without derecruitment, in whom hypoxemia is more likely to be linked to the loss of hypoxic vasoconstriction.

NCT ID: NCT04603313 Completed - Clinical trials for Communicable Diseases

Opinion of the Infectious Disease Specialist Referent for the Good Use of AnTiBiotics

AIRBUS-ATB
Start date: April 15, 2019
Phase:
Study type: Observational

The increase in bacterial resistance and the overuse of antibiotics have led health authorities to propose incentives for the proper use of antibiotics. Among these measures, the introduction of referring physicians for antibiotic therapy and tele-advisory devices for infectious diseases have shown positive effects on antibiotic prescriptions in hospitals. Today, an increase is observed in the consumption of antibiotics linked to ambulatory prescriptions. The objective of the project is to deploy tele-advice devices for general practitioners and to evaluate the effects on ambulatory antibiotic dispensing. AIRBUS-ATB is a prospective, multi-center, population-based, interrupted time-series observational study with a control group with 12 points before and 24 points after the deployment of the intervention in voluntary territories.

NCT ID: NCT04602559 Completed - Clinical trials for Lymphedema of Genitalia

Exploratory Study : to Evaluate the Panty MOBIDERM in Patients With Pelvic and/or Genital Lymphedema

OLYMPY
Start date: December 3, 2020
Phase: N/A
Study type: Interventional

Lymphedema (LO) is a chronic and disabling condition that affects quality of life. This pathology has a physical, psychological, social and professional impact. Pelvic or genital lymphedema (LP/LG) is the result of a dysfunction of the lymphatic system in the genital area that can occur following surgery, radiation therapy, tumor, infections affecting the inguinal lymph nodes or related lymphatic pathways (secondary LP/LG). Urogenital cancers are the major cause of secondary LP/LG. It is difficult to have an accurate estimate of the prevalence of LP/LG. LP/LG can be painful, the edema very bulky and disharmonious. The patient is facing with significant physical and psychological difficulties. The volume of the lymphedema can be important, causing discomfort, rubbing when walking or during physical activities, disrupting daily life and may constitute a major handicap.

NCT ID: NCT04602364 Completed - Fabry Disease Clinical Trials

French Prospective, Observational Cohort Study of Patients With Fabry Disease Treated With Migalastat

Start date: October 15, 2020
Phase:
Study type: Observational

This is a noninterventional cohort study to evaluate the effects of migalastat, on long-term safety, effectiveness, and quality of life (QOL) in patients with Fabry disease.

NCT ID: NCT04602234 Completed - Clinical trials for Ultrasound Therapy; Complications

Diagnostic of Lower Respiratory Tract Infection by Lung Ultrasonography in General Practice

AmbuLUS
Start date: December 30, 2019
Phase: N/A
Study type: Interventional

Lower Respiratory Tract Infection (LRTI) is a frequent motive of consultation in General Practice. Cost, irradiation and availability of traditional imagery make it difficult to perform in every patient with suspected LRTI. The objective is to evaluate the performance of LUS realized by family physicians into the usual LRTI diagnostic pathway. This study is a prospective, interventional, multi-centric and open study conducted in 3 different centers by 15 General Practitioners (GP) in France. Patient complaining of dyspnea or cough were recruited from December 2019 to March 2020. GP received a training course by LUS expert before the study. The primary outcome measure was diagnosis modification after LUS. Secondary measures were therapeutic modification after LUS, decision of imagery prescription after LUS, decision of hospitalization or not after LUS, medical evolution and result of imagery initially prescribed by GP.

NCT ID: NCT04602208 Completed - Prostate Cancer Clinical Trials

FOCAL HIGH-INTENSITY FOCUSED ULTRASOUND FOR PRIMARY LOCALIZED PROSTATE CANCER: MIDTERM ONCOLOGICAL OUTCOMES

Focal HIFU for
Start date: March 1, 2020
Phase:
Study type: Observational

Single-center evaluation of all patients treated for primary localized prostate cancer with focal HIFU from November 2009 to December 2016. To evaluate midterm oncological outcomes of focal HIFU therapy in low an intermediate risk prostate cancer.

NCT ID: NCT04602195 Completed - Clinical trials for Spinal Muscular Atrophy

Responsiveness and Validation Study of MFM-32 in SMA Patients Treated With Nusinersen

NusiMFM
Start date: January 19, 2021
Phase:
Study type: Observational

The Motor Function Measure (MFM), a reliable tool assessing motor function and its progression in most neuromuscular diseases, is widely used in France in many teams. It can be used regardless of the severity of the motor impairment or the ambulatory status of the patient, allowing its use throughout the whole follow-up period of the patient, even in case of the loss of walking. Two versions of the MFM exist, one composed of 32 items originally validated for patients from 6 years old (MFM-32) and a shorter version composed of 20 items originally validated for patients between 2 and 6 years old (MFM-20). In order to prove the possible use of MFM-32 as early as the age of 2 years to validly and reliably monitor the evolution of the motor function of children treated with Nusinersen, we propose in this project to study the sensitivity to treatment-induced change of MFM-32 and the validity of the scale in this population.

NCT ID: NCT04601896 Completed - Clinical trials for Refractory Cardiac Arrest

Evaluation of Quality of Life and Its Influencing Factors After VA-ECMO in Refractory Cardiac Arrest Based on SF-36 Score : A Grenoble Cohort Study From 2006 Through 2018

AQUA
Start date: October 16, 2020
Phase:
Study type: Observational [Patient Registry]

If the ExtraCorporeal Membrane Oxygenation (ECMO) improves survival in the management of refractory cardiac arrest (RCA), this technique is still an invasive technique, not devoid of complications and requiring intensive care that can have serious consequences for patients. If the studies so far show an acceptable quality of life post ECMO in refractory cardiac arrest, the study looks about the quality of life of our patients in Grenoble who survived a refractory cardiac arrest between 2006 and 2018 at the hospital university Grenoble Alps and the factors influencing this quality of life.