title: Ultrasound Guidance in Nerve Block Anaesthesia: Classic Nerve Stimulation Technique Versus Ultrasound-Neurostimulation Combination in Four Blocks: Interscalene, Humeral, Parasacral and Lumbar Blocks

summary: Nerve block anaesthesia is wildly practised in France, avoiding general anaesthesia in a number of cases and producing excellent post-operative analgesia in trauma and orthopaedic surgeries. Even realised by experimented anaesthetists, 5-15% of failures and rare complications (such as vascular puncture, paresthesia, systemic local anaesthetic toxicity, epidural and spinal anaesthesia, neuropathy) are noticed. The aim of the study is the evaluation of an ultrasound-guidance technique in the four predetermined blocks and the incidence of their complications.

location_facility: Unité d'Anesthésiologie et de Réanimation Chirurgicale, Hôpital de Hautepierre


type: Registry Identifier

title: Multidomain Intervention to Prevent Disability in Elders

acronym: MINDED

summary: Prevention of physical disability represents a major priority for the public health system. Physical disability is the final result of a complex cascade of negative events occurring at different levels (i.e., environmental, social, biological, and clinical). The heterogeneity of the underlying mechanisms responsible for the onset of physical disability may require the adoption of preventive interventions affecting multiple domains. Although several studies suggest that single or different combinations of preventive interventions (in particular, physical activity, cognitive training, and healthy diet) might provide beneficial effects in preventing functional loss (and its related features, such as pain or reduced quality of life), very limited evidence coming from clinical trials is currently available on the topic. Intervention trials are usually designed to test the effect of a specific monodimensional intervention on a very selected population, so to reduce the risk of biased results. This approach, although legitimate and methodologically correct, may 1) be insufficient to target the multiple and heterogeneous physiopathological mechanisms underlying the onset of physical disability, and 2) cause a population selection bias leading to difficulties in implementing the study results to the overall older population (thus, determining the "evidence-based medicine" issue in the elderly). To our knowledge, there are no available data from clinical trials evaluating the effects of a multidomain intervention based on lifestyle modifications (e.g., physical activity, cognitive training, nutritional modification) for preventing mobility disability (a very early phase of the disabling process) in community-dwelling older persons. In the present project (Multidomain Intervention to preveNt Disability in ElDers, MINDED), we propose to conduct a pilot study aimed at estimating the effects of a multidomain person-tailored preventive intervention (based on physical activity, cognitive training, and nutritional modifications) on frailty status, physical performance, cognitive function, nutritional status, health-related quality of life, and use of health care services. In addition, we will perform cost-effectiveness analyses of the proposed intervention. The project will yield the necessary preliminary data to design a definitive full-scale Phase 3 randomized clinical trial. By providing a conclusive answer about the effectiveness of a multidimensional preventive program in the primary prevention of major health-related outcomes, the results of the full-scale trial will have relevant clinical and public health implications, and will promote the practicing of a truly evidence-based geriatric medicine.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: Centre de Rééducation Fonctionnelle "La Roseraie"

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Contribution of a Prone Team in Intensive Care During the Covid-19 Epidemic

acronym: COVID-PRONE

summary:
SARS-CoV-2 induced by COVID 19, involved the hospitalization of 101,932 patients in France, including 4,007 in intensive care (source: Santé Publique France). Alsace was one of the most affected regions on the metropolitan territory with a large number of patients hospitalized at the University Hospital of Strasbourg.

In view of the seriousness of the epidemic and the rapid arrival of new patients requiring mechanical ventilation, 3 new intensive care units have been created on the NHC site alone, making it possible to accommodate a maximum of 111 patients (compared to 52 during normal periods).

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

enrollment_type: Anticipated

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service d'Anesthésie-Réanimation - Nouvel Hôpital Civil

status_simplified: Ongoing


title: Integrative Molecular Analysis of Individual Radiosensitivity Among a Population of Pediatric Patients Treated With Radiation in Eastern France.

acronym: ARPEGE BioM

summary: This study aims to explore prospectively the distribution of individual radiosensitivity in the pediatric population and to determine the predictive power of individual radiosensitivity biomarkers from an immunofluorescence technique on primary dermal fibroblasts

status: Terminated

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Bernier-Chastagner V, Hettal L, Gillon V, Fernandes L, Huin-Schohn C, Vazel M, Tosti P, Salleron J, François A, Cérimèle E, Perreira S, Peiffert D, Chastagner P, Vogin G. Validation of a high performance functional assay for individual radiosensitivity in pediatric oncology: a prospective cohort study (ARPEGE). BMC Cancer. 2018 Jul 6;18(1):719. doi: 10.1186/s12885-018-4652-7.

family: Bernier-chastagner

full_name: Valérie Bernier-chastagner

given: Valérie

sequence: first

family: Hettal

full_name: Liza Hettal

given: Liza

sequence: additional

family: Gillon

full_name: Véronique Gillon

given: Véronique

family: Fernandes

full_name: Laurinda Fernandes

given: Laurinda

family: Huin-schohn

full_name: Cécile Huin-schohn

given: Cécile

family: Vazel

full_name: Marion Vazel

given: Marion

family: Tosti

full_name: Priscillia Tosti

given: Priscillia

family: Salleron

full_name: Julia Salleron

given: Julia

family: François

full_name: Aurélie François

given: Aurélie

family: Cérimèle

full_name: Elise Cérimèle

given: Elise

family: Perreira

full_name: Sandrine Perreira

given: Sandrine

family: Peiffert

full_name: Didier Peiffert

given: Didier

family: Chastagner

full_name: Pascal Chastagner

given: Pascal

family: Vogin

full_name: Guillaume Vogin

given: Guillaume

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMC Cancer

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing: No

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
Centre Léon Bérard
CHU de Reims
CHU de Dijon
Hôpital de Hautepierre
CHRU Nancy
Centre Paul Strauss
Institut de Cancérologie de Lorraine
Georges-François-Leclerc
IUCT Oncopole
CHRU toulouse
CHU de Besançon

lead_sponsor_type: industriel

status_simplified: Unknown


title: Screening for Sexually Transmitted Diseases (STDs) in Women Admitted in Family Planning, Lariboisière Hospital, for a Termination of Pregnancy: a Prospective Systematic Survey.

acronym: DEP-IST-IVG

summary: Epidemiology of Sexually Transmitted Diseases (STDs) in women admitted in a Family Planning for a termination of pregnancy is poorly defined currently in France. Only one bi-centre study (Bourgeois-Nicolaos, 2015), performed in two Family Planning suburban centres located within University Hospital (Assistance Publique-Hôpitaux de Paris), found high prevalence: C. trachomatis 15.1%, N. gonorrhoeae 3.1%. Moreover, heterogeneity can occur between centres. In students in Sweden, 26% had one or several previous STDs, mainly C. trachomatis and Human Papilloma Virus (HPV). Having previously a termination of pregnancy was a risk factor of STDs. Systematic screening for STDs in Women Admitted in Family Planning for a Termination of Pregnancy appears thus a logical strategy.

status: Unknown status

time_perspective: Prospective

lead_sponsor: Hopital Lariboisière

location_facility: Family Planning Centre, Obstetrics Dpt, Lariboisière Hosp,


title: Interest of a Steroid Pre-treatment Prior to IVF Protocol With Ovarian Stimulation by Recombinant FSH and With LH Surge Blockage by Daily GnRH Antagonist

summary: The purpose of this study is to assess whether estrogen pre-treatment can allow retrieval of 2 additional oocytes in GnRH antagonist protocol.

primary_purpose: Treatment

ReferenceCitation: Cédrin-Durnerin I, Guivarc'h-Levêque A, Hugues JN; Groupe d'Etude en Médecine et Endocrinologie de la Reproduction. Pretreatment with estrogen does not affect IVF-ICSI cycle outcome compared with no pretreatment in GnRH antagonist protocol: a prospective randomized trial. Fertil Steril. 2012 Jun;97(6):1359-64.e1. doi: 10.1016/j.fertnstert.2012.02.028. Epub 2012 Mar 28.

family: Cédrin-Durnerin

full_name: Isabelle Cédrin-Durnerin

given: Isabelle

family: Guivarc'h-Levêque

full_name: Anne Guivarc'h-Levêque

given: Anne

family: Hugues

full_name: Jean-Noël Hugues

given: Jean-Noël

journal_name: Fertility and Sterility

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Gemer

location_facility: Service de Medecine de la Reproduction, Hôpital Jean Verdier

intervention_type: Drug


title: Construction of a Multidimensional Score for the Functional Prognosis of Cerebral Infarctions

acronym: ICDIM 1

summary:
In France, stroke is the leading cause of non-traumatic acquired motor disability in adults, the second leading cause of major cognitive impairment, and the third leading cause of death in men and women. The average age of onset is 73 years (70 years for men, 76 years for women). All types combined, approximately 100,000 patients are hospitalized for stroke each year, approximately 40,000 people die and 30,000 have serious after-effects at one year. The spectrum of functional sequelae ranges from motor and sensory impairment to cognitive impairment; moreover, 30 to 50% of patients have a recurrence within 5 years.

Data from the Dijon Stroke Registry showed in 2011 that only 36% of people who had a stroke between 2000 and 2009 were symptom-free 1 month after the event; 22% of patients had mild or moderate disability according to the modified Rankin Scale (mRS); and 42% were unable to walk without assistance or had died. Based on 2009 self-reported data, more than one in two (51%) of those with a history of stroke with sequelae reported significant difficulty or inability to walk 500 meters; 45% had difficulty with at least one activity of daily living. The mortality rate was 44.7 per 100 000 persons in 2013.

Cerebral infarctions (CIs) account for the majority of strokes (70-75%). In 2014, despite a 12.5% decrease from 2008, hospital case fatality for CIs remained high at 9%. In 2015, the case fatality rate was 10.7% at 30 days and 11.9% at 1 year. Thirty-day mortality alone concentrated nearly half (47%) of the 1-year mortality.

study_start_date_type: Anticipated

status: Not yet recruiting

time_perspective: Retrospective

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Effects of Levosimendan Pretreatment in Patients With Low Ejection Fraction (40 % or Less) Undergoing CABG: a Randomised, Double Blind, Multicenter Trial

acronym: LICORN

summary: The investigators want to test the hypothesis that an infusion of levosimendan started prior to CABG surgery can reduce incidence and severity of low cardiac output syndrome in patients with poor LV function (EF 40% or less).

ReferenceType: background

ReferenceCitation: Levin R, Degrange M, Del Mazo C, Tanus E, Porcile R. Preoperative levosimendan decreases mortality and the development of low cardiac output in high-risk patients with severe left ventricular dysfunction undergoing coronary artery bypass grafting with cardiopulmonary bypass. Exp Clin Cardiol. 2012 Sep;17(3):125-30.

ReferenceCitation: De Hert SG, Lorsomradee S, Cromheecke S, Van der Linden PJ. The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg. 2007 Apr;104(4):766-73. Erratum in: Anesth Analg. 2007 Jun;104(6):1544. Dosage error in article text.

ReferenceCitation: Tritapepe L, De Santis V, Vitale D, Santulli M, Morelli A, Nofroni I, Puddu PE, Singer M, Pietropaoli P. Preconditioning effects of levosimendan in coronary artery bypass grafting--a pilot study. Br J Anaesth. 2006 Jun;96(6):694-700. Epub 2006 Apr 4.

ReferenceCitation: Cholley B, Caruba T, Grosjean S, Amour J, Ouattara A, Villacorta J, Miguet B, Guinet P, Lévy F, Squara P, Aït Hamou N, Carillion A, Boyer J, Boughenou MF, Rosier S, Robin E, Radutoiu M, Durand M, Guidon C, Desebbe O, Charles-Nelson A, Menasché P, Rozec B, Girard C, Fellahi JL, Pirracchio R, Chatellier G; -. Effect of Levosimendan on Low Cardiac Output Syndrome in Patients With Low Ejection Fraction Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass: The LICORN Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):548-556. doi: 10.1001/jama.2017.9973.

name: Department of Anesthesiology and Critical Care Medicine, Hôpital Européen Georges Pompidou, AP-HP, and University Paris Descartes-Sorbonne Paris Cité, Paris, France

family: Cholley

full_name: Bernard Cholley

given: Bernard

name: Department of Pharmacy, Hôpital Européen Georges Pompidou, AP-HP, and University Paris Descartes-Sorbonne Paris Cité, Paris, France

family: Caruba

full_name: Thibaut Caruba

given: Thibaut

name: Department of Anesthesiology and Critical Care Medicine, Centre Hospitalo-Universitaire de Dijon-Bourgogne, France

family: Grosjean

full_name: Sandrine Grosjean

name: Department of Anesthesiology and Critical Care Medicine, Hôpital de La Pitié Salpêtrière, AP-HP, and University Pierre & Marie Curie, Paris, France

family: Amour

full_name: Julien Amour

given: Julien

name: Department Department of Anaesthesiology and Critical Care II, Magellan Medico-Surgical Center, and University of Bordeaux, INSERM, UMR 1034, Biology of Cardiovascular Diseases, Bordeaux, France

family: Ouattara

full_name: Alexandre Ouattara

given: Alexandre

name: Department of Anesthesiology and Critical Care, CHU La Timone, Marseille, France

family: Villacorta

full_name: Judith Villacorta

given: Judith

name: Department of Anesthesiology and Critical Care Medicine, Hôpital Laënnec, Nantes, France

family: Miguet

full_name: Bertrand Miguet

given: Bertrand

name: Department of Anesthesiology and Critical Care Medicine, Hôpital Pontchaillou, Rennes, France

family: Guinet

full_name: Patrick Guinet

given: Patrick

name: Department of Anesthesiology and Critical Care, Nouvel Hôpital Civil, Strasbourg, France

family: Lévy

full_name: François Lévy

given: François

name: Department of Anesthesiology and Critical Care, Clinique Ambroise Paré, Neuilly, France

family: Squara

full_name: Pierre Squara

given: Pierre

family: Aït Hamou

full_name: Nora Aït Hamou

given: Nora

family: Carillon

full_name: Aude Carillon

given: Aude

family: Boyer

full_name: Julie Boyer

given: Julie

family: Boughenou

full_name: Marie-Fazia Boughenou

given: Marie-Fazia

family: Rosier

full_name: Sebastien Rosier

given: Sebastien

name: Department of Anesthesiology and Critical Care, Hôpital Claude Huriez, Lille, France

family: Robin

full_name: Emmanuel Robin

given: Emmanuel

name: Department of Anesthesiology and Critical Care, CHU Côte de Nacre, Caen, France

family: Radutoiu

full_name: Mihail Radutoiu

given: Mihail

name: Department of Anesthesiology and Critical Care, CHU Grenoble Alpes, Grenoble, France

family: Durand

full_name: Michel Durand

given: Michel

family: Guidon

full_name: Catherine Guidon

given: Catherine

name: Department of Anesthesiology and Critical Care, Hôpital Cardiologique Louis Pradel and INSERM U1060, University Claude Bernard, Lyon, France

family: Desebbe

full_name: Olivier Desebbe

given: Olivier

name: Department of Biostatistics, Hôpital Européen Georges Pompidou, AP-HP, and University Paris Descartes-Sorbonne Paris Cité, Paris, France

family: Charles-Nelson

full_name: Anaïs Charles-Nelson

given: Anaïs

name: Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou, AP-HP, and University Paris Descartes-Sorbonne Paris Cité, Paris, France

family: Menasché

full_name: Philippe Menasché

given: Philippe

family: Rozec

ReferenceCitation: Caruba T, Hourton D, Sabatier B, Rousseau D, Tibi A, Hoffart-Jourdain C, Souag A, Freitas N, Yjjou M, Almeida C, Gomes N, Aucouturier P, Djadi-Prat J, Menasché P, Chatellier G, Cholley B. Rationale and design of the multicenter randomized trial investigating the effects of levosimendan pretreatment in patients with low ejection fraction (≤40 %) undergoing CABG with cardiopulmonary bypass (LICORN study). J Cardiothorac Surg. 2016 Aug 5;11(1):127. doi: 10.1186/s13019-016-0530-z.

location_facility: Hôpital Européen Georges Pompidou, Assistance Publique Hôpitaux de Paris, France


title: Multicentre Observational Study on Management COVID 19 Positive Outpatients in a French Cluster.

acronym: COVID AMBU 60

summary:
Since December 2019, a new agent, the coronavirus SARS-Cov-2, has spread from China to the rest of the world causing an international epidemic of respiratory diseases called COVID-19. Oise was one of the first clusters in France, with more than 4,000 confirmed cases. A significant proportion (80%) of patients with COVID-19 are ambulatory. However, few data are available for this particular population in France. Thus, few clear recommendations are available.

We propose to conduct a large cohort of observation of suspected or confirmed COVID-19 patients on an ambulatory basis in the Oise region. This observatory will make it possible to describe the epidemiological characteristics and initial management of COVID-19 patients and to identify early severity factors.

ipd_sharing: Undecided

lead_sponsor: Maison de Sante Pluridisciplinaire de Creil


title: Non Interventional Study on Pulmonary Valve Replacement by Thranscatheter Pulmonary Valve Melody™

acronym: Melody™FR

summary:
Prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period.

This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in France.

lead_sponsor: Medtronic Bakken Research Center

location_facility:
Hôpital Laënnec
Hôpital Louis Pradel
Hôpital de La Timone Enfants
Hôpital Gabriel Montpied
Centre chirurgical Marie Lannelongue
Hôpital des enfants Purpan
Clinique Pasteur
Hôpital Cardiologique
Hôpital des enfants Malades Necker
Hôpital Cardiologique du Haut-Lévêque

intervention_type: Device


title: Urological Management of Complications of Penile Constriction Devices: French National Retrospective Study and Literature Review

acronym: PCD

summary:
Wearing a penile ring is justified by international societies of Urology (AFU, EAU, AUA) only for the treatment of erectile dysfunction with vacuum. In this case, it is a constriction rubber band that can only be worn for 30 minutes.

Nowadays, wearing a cockring device for recreational purposes can lead to complications secondary to ischemia caused by strangulation of the penis and/or scrotum.

The variety of devices and materials used (metallic and/or alloys in particular) sometimes makes it difficult to remove them, requiring expensive surgery and dedicated equipment.

There is no official recommendation for the management of these complications.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Evaluation of the Modalities of Administration of Synthetic Oxytocin During Spontaneous Labor

acronym: LAMA

summary:
Syntocinon was granted marketing authorization in France in 1970. Since the 1960s, it has been frequently used during childbirth, particularly in cases of stagnation of cervical dilatation due to a lack of uterine contractility. According to the latest National Perinatal Survey of 2010, 66.5% of patients go into labor spontaneously and 58% of them receive Syntocinon during labor.

The reported maternal effects associated with the use of synthetic oxytocin include uterine hyperactivity, postpartum hemorrhage (PPH) and severe PPH. The administration of oxytocin increases the risk of uterine hyperactivity in a dose-dependent manner. Regarding fetal risk, the reported adverse effects concern fetal heart rate abnormalities related to uterine hyperactivity. However, no study has shown an association between oxytocin administration and excess neonatal morbidity and mortality, except in the subpopulation of patients with a scarred uterus.


title: Restoring Vision With the Intelligent Retinal Implant System (IRIS V1)in Patients With Retinal Dystrophy (Title in France: Compensation of Vision With the Intelligent Retinal Implant System (IRIS V1) in Patients With Retinal Dystrophy)

summary: This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V1)

lead_sponsor: Pixium Vision SA

location_country: Austria Germany France

location_facility: Dept. of Ophthalmology, University of Bonn

location_facility: Hopital des Quinze Vingts/Fondation Ophtalmologique A. De Rothschild

location_facility: Klinik und Poliklinik für Augenheilkunde Hamburg-Eppendorf

location_facility: Clinique Ophtalmologique du CHU de Nantes


title: Prospective Evaluation of Outpatient Surgery in the Anterior Cruciate Ligament Reconstructions With Hamstring Hospital

acronym: DIDTGENOU

summary:
Care in ambulatory surgery (CA) is growing in France, despite lagging behind other countries in North or US Europe. Arthroscopic knee surgery is a minimally invasive surgery eligible for CA. Currently 71.8% of knee arthroscopy are made in this context. However ligamentoplasties anterior cruciate are still carried out predominantly in conventional hospitalization (HC) with a median of 3 to 5.5 days of stay.

Two recent prospective studies French single-operator shows the feasibility of reconstruction of the anterior cruciate ligament (ACL) in ambulatory: no serious events were recorded, the risks are comparable to those of a HC.

However, this support requires a structure and a coordinated network between different medical and paramedical (surgeons, anesthetists, nurse frame, City nurse, doctor, physiotherapist).

The objective of the study is to evaluate (i.e. EPP or "feasibility") ACL reconstruction in CA in hospitals, multi-operator.

intervention_type: Procedure


title: Computer Based, vs Human Based Assessment of Kidney Allograft Failure Prediction and Stratification

acronym: iBox vs Human

summary: The clinical decision-making after kidney transplantation is mainly driven by patient individual assessment. However, this task remains difficult and uncertain due to the integration of complex and numerous parameters. We aim to evaluate and compare the ability of transplant physicians to predict long term allograft survival compared with a computer-based survival prediction algorithm (iBox system).

ReferenceCitation: Loupy A, Aubert O, Orandi BJ, Naesens M, Bouatou Y, Raynaud M, Divard G, Jackson AM, Viglietti D, Giral M, Kamar N, Thaunat O, Morelon E, Delahousse M, Kuypers D, Hertig A, Rondeau E, Bailly E, Eskandary F, Böhmig G, Gupta G, Glotz D, Legendre C, Montgomery RA, Stegall MD, Empana JP, Jouven X, Segev DL, Lefaucheur C. Prediction system for risk of allograft loss in patients receiving kidney transplants: international derivation and validation study. BMJ. 2019 Sep 17;366:l4923. doi: 10.1136/bmj.l4923.

apc_source: openAPC

family: Loupy

full_name: Alexandre Loupy

given: Alexandre

family: Aubert

full_name: Olivier Aubert

family: Orandi

full_name: Babak J Orandi

given: Babak J

family: Naesens

full_name: Maarten Naesens

given: Maarten

family: Bouatou

full_name: Yassine Bouatou

given: Yassine

family: Raynaud

full_name: Marc Raynaud

given: Marc

family: Divard

full_name: Gillian Divard

given: Gillian

family: Jackson

full_name: Annette M Jackson

given: Annette M

family: Viglietti

full_name: Denis Viglietti

given: Denis

family: Giral

full_name: Magali Giral

given: Magali

family: Kamar

full_name: Nassim Kamar

given: Nassim

family: Thaunat

full_name: Olivier Thaunat

family: Morelon

full_name: Emmanuel Morelon

family: Delahousse

full_name: Michel Delahousse

family: Kuypers

full_name: Dirk Kuypers

given: Dirk

family: Hertig

full_name: Alexandre Hertig

family: Rondeau

full_name: Eric Rondeau

given: Eric

family: Bailly

full_name: Elodie Bailly

given: Elodie

family: Eskandary

full_name: Farsad Eskandary

given: Farsad

family: Böhmig

full_name: Georg Böhmig

given: Georg

family: Gupta

full_name: Gaurav Gupta

given: Gaurav

family: Glotz

full_name: Denis Glotz

family: Legendre

full_name: Christophe Legendre

given: Christophe

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

lead_sponsor: Paris Translational Research Center for Organ Transplantation

location_facility: Paris Translational Centre for Organ Transplantation


title: A Community Pharmacist-led Intervention to Improve Screening of Sleep Apnea in Primary Care

summary: The purpose of this study is to evaluate the feasibility and the effectiveness of sleep apnea screening program for patients at risk in community pharmacies.

primary_purpose: Screening


title: French National Registry of Bone Marrow Failures: Prospective and Retrospective Database Associated to a Collection of Biological Samples: RIME Project

acronym: RIME

summary:
This is a unique clinical and biological database that collects standardized clinical information during the management of all patients with bone marrow failure syndromes (BMF) in France (multicenter registry), from diagnosis and throughout follow-up during the natural history of the disease, treated or not. In parallel, biological samples (blood and/or bone marrow and/or skin) are collected during clinical care and are biobanked in Saint-Louis Hospital (Hematology laboratory) in order to be used in translational research related to bone marrow failure diseases.

This registry has two main objectives:

Public health care evaluation and improvement: to assess the medical and social needs inherent to the management of these rare diseases; to precisely assess the level of diagnosis and management of bone marrow failure syndromes in France; to evaluate the impact and guidance of the French reference center guidelines for diagnosis and treatment; to evaluate the real-life efficacy and tolerance of any given specific treatments; to analyze treatment's cost-effectiveness according to each situation.

Research:

Epidemiology: to determine the incidence, prevalence, and distribution of different bone marrow failure syndromes at the national level;
Biology: to better understand the pathophysiology of BMF; to identify and to study complications within each entity, such as mechanisms underlying clonal evolution, new forms of inherited BMF and acute myeloid leukemia (AML)/MDS-predisposition syndromes, and to better and deeper characterize known entities;
Treatment: to identify prognostic factors and predictors of response; to identify side effects and impact of treatment on others organs and natural functions; to assess patients' quality of life as early as possible since diagnosis and throughout follow-up.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: ImPROving prenaTal carE During ConfinemenT: Impact of Confinement on the Quality of Prenatal Care Perceived in Low-risk Pregnancy

acronym: PROTECT

summary: This study is a non-randomized, quasi-experimental, monocentric study comparing two prenatal monitoring modes in low-risk pregnancy: including at least one remote consultation (phone or teleconsultation) versus face-to-face adapted to confinement. The quality of care perceived by the pregnant women were evaluated according to monitoring modes set up during the COVID-19 pandemic confinement period. The women included planned to give birth at the regional academic Maternity of Nancy, France.

status: Active, not recruiting

lead_sponsor: Central Hospital, Nancy, France

location_facility: Maternité Régionale Universitaire de Nancy


acronym: PUFPAE

summary:
The purposes of this study are :

To know and to understand frequency and variability (quantitative and qualitative) of end-of-life emergencies in nursing homes.
To know and to understand practices applied in these situations depending on the institution and the different reasons of hospital use.
To know and to understand the practical and organizational elements, in nursing homes, that can determine a (re) hospitalization or an end-of-life

lead_sponsor: Rennes University Hospital


title: Etude 3000 ARTHROSES Symptomatic Knee and Hip Osteoarthritis Prevalence Survey. Programme de Recherche du Groupe Qualité de Vie, de la Section Epidémiologie et de la Section Arthrose de la Société Française de Rhumatologie

summary: Nationwide descriptive epidemiology survey aiming to determine lower limb OA prevalence, based on a validated method previously used to assess inflammatory rheumatism (rheumatoid arthritis and spondylarthropathy) prevalence in France.

time_perspective: Cross-Sectional

ReferenceCitation: Guillemin F, Rat AC, Mazieres B, Pouchot J, Fautrel B, Euller-Ziegler L, Fardellone P, Morvan J, Roux CH, Verrouil E, Saraux A, Coste J; 3000 Osteoarthritis group. Prevalence of symptomatic hip and knee osteoarthritis: a two-phase population-based survey. Osteoarthritis Cartilage. 2011 Nov;19(11):1314-22. doi: 10.1016/j.joca.2011.08.004. Epub 2011 Aug 16.

family: Guillemin

full_name: F. Guillemin

given: F.

family: Rat

full_name: A.C. Rat

family: Mazieres

full_name: B. Mazieres

given: B.

family: Pouchot

full_name: J. Pouchot

given: J.

family: Fautrel

full_name: B. Fautrel

family: Euller-Ziegler

full_name: L. Euller-Ziegler

given: L.

family: Fardellone

full_name: P. Fardellone

given: P.

family: Morvan

full_name: J. Morvan

family: Roux

full_name: C.H. Roux

family: Verrouil

full_name: E. Verrouil

given: E.

family: Saraux

full_name: A. Saraux

given: A.

family: Coste

full_name: J. Coste

journal_name: Osteoarthritis and Cartilage

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: Prevalence of symptomatic hip and knee osteoarthritis: a two-phase population-based survey1

location_facility: Service de Rhumatologie. CHU de la Cavale Blanche

location_facility: Centre d'Epidémiologie Clinique. Service de rhumatologie. CHU Nancy

location_facility: Service de Rhumatologie. Hôpital de la Pitié-Salpêtrière

location_facility: Service de Rhumatologie. Hôpital Rangueil


title: Acceptability of Human Papillomavirus Self-sampling in Women Living With HIV

acronym: AUTOCol

summary: Women living with HIV are unsufficiently screened for cervix cancer although they have a higher risk of developping it, resulting of many obstacles. Offering a new screening technique, more accessible and which doesn't require gynecologic examination, could help improving this coverage rate. HPV screening have a higher-performance for cervix cancer than smear test. Self-collected vaginal swabs are as efficient as vaginal swabs collected by clinicians. They are also proved acceptable among general population but only one study in South Africa is about women living with HIV. The main hypothesis is that self-collected vaginal swabs are also acceptable among women living with HIV in the CoreVIH IDF Nord cohort.


title: Positioning, Utilization and Effectiveness of Osimertinib in First Line in Real-life Therapeutic Strategy in France Prospective Cohort of Locally Advanced and Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations

acronym: POSITHES

summary:
This is an observational multicenter study. A cross-sectional descriptive study of patients with locally advanced or metastatic Non Small Cell Lung Cancer with activating EGFR mutation treated by any first line therapy will be used to identify cohort with a prospective follow-up of patients initiating a treatment by osimertinib in first line

A cross-sectional descriptive study of all patients with locally advanced or metastatic NSCLC with activating EGFR mutation treated by any first line therapy will be collected at the study participating sites. The study which is transversal will allow to characterize the population of patients with locally advanced or metastatic NSCLC with activating EGFR mutation treated in first line, the day of first line initiation.
Additionally, a prospective study targeting a cohort of patients focusing on patients with locally advanced or metastatic NSCLC with activating EGFR mutation initiating a treatment by osimertinib in first line will be conducted to address describe in real life conditions the 36-months overall survival, patients baseline characteristics, disease evolution, sequencing and treatment patterns, and quality of life.

lead_sponsor: AstraZeneca


title: Retrospective Clinical Study of Malaria in Strasbourg University

acronym: ACMUS

summary: The primary purpose is to describe the anamnestic, clinical, biological, and therapeutic characteristics of imported malaria in people originated from endemic areas. Indeed, clinicians have observed that people from such areas start malaria just after their arrival in France. Such observation needed to be confirmed. In addition, The investigators observed a variation in the laboratory diagnostic performance of malaria between hospital and private laboratories. Such observation also needed to be analyzed objectively

location_facility: Service de Maladies Infectieuses et Tropicales


title: Etude de la Performance Diagnostique de l'EEG-Haute Résolution Sur la Localisation de la Zone épileptogène Pour le Traitement Chirurgical Des épilepsies Partielles Pharmaco-résistantes

acronym: EEG-HR

summary: Multicenter prospective study comparing the diagnosis value of high-resolution EEG and depth-EEG to localize the epileptogenic zone in drug resistant partial epilepsies.

design_allocation: Non-Randomized

ReferenceCitation: Maillard L, Koessler L, Colnat-Coulbois S, Vignal JP, Louis-Dorr V, Marie PY, Vespignani H. Combined SEEG and source localisation study of temporal lobe schizencephaly and polymicrogyria. Clin Neurophysiol. 2009 Sep;120(9):1628-36. doi: 10.1016/j.clinph.2009.06.022. Epub 2009 Jul 24.

ReferenceCitation: Koessler L, Benar C, Maillard L, Badier JM, Vignal JP, Bartolomei F, Chauvel P, Gavaret M. Source localization of ictal epileptic activity investigated by high resolution EEG and validated by SEEG. Neuroimage. 2010 Jun;51(2):642-53. doi: 10.1016/j.neuroimage.2010.02.067. Epub 2010 Mar 4.

ReferenceType: result

ReferenceCitation: Koessler L, Cecchin T, Caspary O, Benhadid A, Vespignani H, Maillard L. EEG-MRI co-registration and sensor labeling using a 3D laser scanner. Ann Biomed Eng. 2011 Mar;39(3):983-95. doi: 10.1007/s10439-010-0230-0. Epub 2010 Dec 8.

family: Koessler

full_name: L. Koessler

family: Cecchin

full_name: T. Cecchin

given: T.

family: Caspary

full_name: O. Caspary

given: O.

family: Benhadid

full_name: A. Benhadid

family: Vespignani

full_name: H. Vespignani

given: H.

family: Maillard

full_name: L. Maillard

journal_name: Annals of Biomedical Engineering

publisher_dissemination: Springer

publisher_group: Springer

title: EEG–MRI Co-registration and Sensor Labeling Using a 3D Laser Scanner

ReferenceCitation: Koessler L, Salido-Ruiz R, Ranta R, Louis-Dorr V, Gavaret M, Maillard L. Influence of source separation and montage on ictal source localization. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:2898-901. doi: 10.1109/IEMBS.2010.5626321.

full_name: L Koessler

given: L

family: Salido-Ruiz

full_name: R Salido-Ruiz

given: R

family: Ranta

full_name: R Ranta

family: Louis-Dorr

full_name: V Louis-Dorr

given: V

family: Gavaret

full_name: M Gavaret

given: M

full_name: L Maillard

bso_classification:
Computer and
 information sciences

genre: proceedings

genre_raw: proceedings-article

journal_name: 2010 Annual International Conference of the IEEE Engineering in Medicine and Biology

publisher: IEEE

publisher_dissemination: IEEE

publisher_group: IEEE

publisher_normalized: IEEE

location_facility:
University Hospital of Marseille
Central Hospital


title: Treatment of Resistant Depression by Repetitive Transcranial Magnetic Stimulation (rTMS) Multicentric Naturalistic Study

acronym: DSNATUR

summary: Repetitive Transcranial Magnetic Stimulation (rTMS) for repetitive Transcranial Magnetic Stimulation) is a a recent technique to stimulate the brain in a way that non-invasive, for therapeutic purposes. The first trials of analgesic use of rTMS date back to about 15 years ago. years and clinical use has now entered the practice of some specialized centers. Used at a frequency less than or equal to 1 Hertz (Hz; a stimulation per second), it is called bass rTMS. frequency and results in inhibition of cortical excitability at the level of the stimulated area. Conversely, a stimulation with a frequency higher than 5 Hz, called high-frequency rTMS, will have an excitatory effect on the targeted neurons. In addition to its local effects at the stimulation site, rTMS can also have effects on distance on regions other than those directly targeted. The impact of this treatment would be the local modulation of the cerebral plasticity and also act on the anatomical connectivity and functional brain function in both healthy subjects and those who are patients with psychiatric disorders

lead_sponsor: Centre hospitalier de Ville-Evrard, France

location_facility:
Youcef Bencherif
Unité de recherche clinique


title: A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection in France and Belgium

summary: Comparison of the effects of CYT107 vs Placebo administered IM at 10μg/ kg twice a week for two weeks on immune reconstitution of lymphopenic COVID-19 patients.

ReferenceCitation: Francois B, Jeannet R, Daix T, Walton AH, Shotwell MS, Unsinger J, Monneret G, Rimmelé T, Blood T, Morre M, Gregoire A, Mayo GA, Blood J, Durum SK, Sherwood ER, Hotchkiss RS. Interleukin-7 restores lymphocytes in septic shock: the IRIS-7 randomized clinical trial. JCI Insight. 2018 Mar 8;3(5). pii: 98960. doi: 10.1172/jci.insight.98960.

family: Francois

full_name: Bruno Francois

given: Bruno

family: Jeannet

full_name: Robin Jeannet

given: Robin

family: Daix

full_name: Thomas Daix

given: Thomas

family: Walton

full_name: Andrew H. Walton

given: Andrew H.

family: Shotwell

full_name: Matthew S. Shotwell

given: Matthew S.

family: Unsinger

full_name: Jacqueline Unsinger

given: Jacqueline

family: Monneret

full_name: Guillaume Monneret

given: Guillaume

family: Rimmelé

full_name: Thomas Rimmelé

family: Blood

full_name: Teresa Blood

given: Teresa

family: Morre

full_name: Michel Morre

given: Michel

family: Gregoire

full_name: Anne Gregoire

given: Anne

family: Mayo

full_name: Gail A. Mayo

given: Gail A.

full_name: Jane Blood

given: Jane

family: Durum

full_name: Scott K. Durum

given: Scott K.

family: Sherwood

full_name: Edward R. Sherwood

given: Edward R.

family: Hotchkiss

full_name: Richard S. Hotchkiss

given: Richard S.

currency_apc_doaj: USD

journal_name: JCI Insight

evidence: open (via free pdf)

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: Washington University School of Medicine - Digital Commons@Becker

version: submittedVersion

publisher: American Society for Clinical Investigation

ReferenceCitation: Venet F, Foray AP, Villars-Méchin A, Malcus C, Poitevin-Later F, Lepape A, Monneret G. IL-7 restores lymphocyte functions in septic patients. J Immunol. 2012 Nov 15;189(10):5073-81. doi: 10.4049/jimmunol.1202062. Epub 2012 Oct 10.

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

ReferenceCitation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum in: JAMA. 2021 Mar 16;325(11):1113.

name: Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Pulmonary Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Infectious Disease, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Emergency Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Laboratory Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

title: Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus–Infected Pneumonia in Wuhan, China

location_facility:
Hôpital Edouard Herriot
hopital Edouard Herriot
Chr Orleans La Source
Chru Tours
hopital COCHIN
University Hospital of Limoges


title: Follicular Flushing for Poor Responder Patient in an Assisted Reproductive Technology Program: Flush Study

summary: The object of this study is to determine the benefit of follicular flushing with a double channel needle in a poor responder population for a maximum number of oocytes to be retrieved. The investigators compare two methods of oocyte retrieval with or without flushing. 220 patients undergoing an in vitro fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) have to be included. All patients with less than 5 follicles of 14 mm and more the day of ovulation induction will be included, following a randomized protocol in two groups, Group A: Oocyte retrieval is performed with a single lumen aspiration needle 17G. Group B: Oocyte retrieval is performed with a double lumen aspiration needle 17G. all follicles are flushed with flushing solution in addition to direct aspiration of the follicular fluid, 20CC of flushing medium is provided for all the procedure and flushing medium is collected separately from direct fluid aspiration in order to follow up each oocyte one by one. First criterion of our comparison is the number of oocyte retrieved. Second criteria are: oocyte quality, fertilization rate, number and quality of embryos obtained, clinical pregnancy rate. In Group B the investigators will compare two subgroups: oocytes collected in flush medium and oocytes from direct follicle fluid. Then the investigators will know the capability of oocyte collected after follicular flushing to be fertilized and to increase the success chance of pregnancy for poor responder patients.

primary_purpose: Other

location_facility: Centre d'Assistance Médicale à la Procréation, CMCO-SIHCUS


title: Epidemiological Study on Mental Health of Migrant Population in the Retention Center of Geispolsheim

summary:
In 2019, the lack of studies about mental health of the detained population at retention centers in France is pointed out by the report of Controller-General for Places of Deprivation of Liberty. The aim of this study is to contribute to this relatively untouched field by describing which psychiatric pathologies are encountered in this population who went through migration and retention. Having a clearer picture of the situation can help to provide a more adapted psychiatric care in retention centers.

The results are expected to show a higher rate of psychiatric disease than in the general population including addiction to substance, anxiety disorder and post-traumatic stress disorder (PTSD).

location_facility: Les Hôpitaux Universitaires de Strasbourg

intervention_type: Behavioral


title: Evaluation of Intestinal and Hepatic Parts in Fasting Postprandial Hypertriglyceridemia in Patients With or Without Metabolic Syndrome

acronym: TRIGPP

summary:
Fasting and postprandial hypertriglyceridemia (HTG) depends on increased production of intestinal triglyceride rich lipoproteins in patients with isolated fasting hypertriglyceridemia.

The objective of this study is to compare the serum apoB48 rate after a standardized load test, among patients with isolated hypertriglyceridemia and patients with metabolic syndrome.

ReferenceCitation: Giral P, Simon D, Chapman MJ. Letter by Giral et al regarding article, "lipoprotein(a) concentrations, rosuvastatin therapy, and residual vascular risk: an analysis from the JUPITER trial (justification for the use of statins in prevention: an intervention trial evaluating rosuvastatin)". Circulation. 2014 Oct 21;130(17):e151. doi: 10.1161/CIRCULATIONAHA.114.009590.


title: Efficiency of the Imaging Strategy for the Management of Suspected Covid-19

summary: Emergency departments have been placed at the heart of the patient triage strategy during the COVID-19 epidemic. In the absence of scientific knowledge on the most efficient strategy to put in place in emergency structures, the centers have proposed very heterogeneous protocols resulting from collaboration with local radiology and virology teams. While the pandemic in France appears to be currently under control, it is important to assess the sorting strategies put in place to deal with a new epidemic.

location_facility: Service d'accueil des urgences - Hôpitaux Universitaires de Strasbourg


title: Seroprevalence of SARS-CoV-2 Antibodies Among Adult Patients Living With HIV

acronym: SeCoVIHA

summary: North-east area of France was hit in February 2020 by the new coronavirus disease, more severely than other French regions. Factors affecting the evolution of the disease and its severity have been quickly identified, among them figuring different kinds of immune deficiency. Even if nowadays HIV infection is usually well controlled by ARV drugs, those patients with uncontrolled viral load and/or low CD4 cell counts, remain at higher risk of severe COVID infection. In this context, the primary objective of our study is aimed at evaluating the prevalence of SARS-CoV-2 antibodies in a cohort of HIV-infected patients followed-up in an HIV-infection care center. Secondary objectives are: evaluating whether the antibodies are protective or not, the kinetic of these antibodies, and HIV associated factors with the presence of antibodies.


title: Patient Satisfaction During Artificial Induction of Labor by Cervical Ripening

acronym: CERVICAL

summary:
20% of deliveries take place following an artificial induction of labor. The latter sometimes requires prior cervical ripening, of which the two most widely used methods in France are oral misoprostol and the balloon catheter, left to the discretion of clinicians.

The objective of this study is to observe which cervical maturation method patients choose when an artificial induction of labor with an unfavorable cervical status must be carried out, and to observe the patient's criteria as to the choice made, as well as their experience and their satisfaction with artificial induction of labor, in order to improve our clinical practices, the experience of childbirth, and promote patient autonomy.

location_facility: Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg


title: Pilot, Interventional Study of the Specific Anti-HBV Vaccine Response After Vaccination in Patients Requiring Anti-CD20 Monoclonal Antibodies

summary:
Vaccination coverage against HBV in France is around 30% in the adult population. Treatment with anti-CD20 is associated with a risk of reactivation of hepatitis B or acute or fulminant hepatitis in first-infected patients. HBV vaccination is recommended as before any anti-CD20 treatment in unimmunized patients.

However, there is no recommendation on which vaccination regimen to choose in patients on immunosuppressants / corticosteroids or with inflammatory or autoimmune disease.

For patients who have a need for rapid immunosuppressive therapy, the use of a standard vaccination schedule (D0, M1, M6) would be responsible for a loss of chance vis-à-vis the underlying disease with a delay of more than 6 months to start treatment with anti-CD20. An accelerated regimen (D0, D7, D21 and M12) allows healthy adults to obtain very rapid vaccine protection between 77 and 90.8%. The accelerated regimen can also be considered on a case-by-case basis in those adults with neurological pathologies, systemic vasculitis or autoimmune disease and who need to receive anti-CD20 antibodies if the combination of injections over a short period is likely to promote immunization.

The advantage of the accelerated regimen is to obtain 4 weeks, after the third dose of vaccine, anti-HBs antibodies at a protective level (> 10 IU / L) in approximately 77 to 90.8% of patients and in the general population. The booster injection at 12 months is essential for long-term protection.

lead_sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

intervention_type: Biological


title: Comparison of Fissurectomy to Fissurectomy With Anoplasty

acronym: ANOFIS

summary: Surgery is sometimes necessary to relieve patients with chronic anal fissure. It consists of resecting the edges of the fissure to make a wound larger than the initial fissure, in order to obtain healing. Thus, the edges of the wound do not stick together and the healing is done from the bottom of the wound. This procedure is widely performed in France with results that seem satisfactory. In addition to resection of the fissure, a partial closure of the wound can be associated with a small flap of rectal mucosa which is sutured with a few absorbable stitches: this is anoplasty.


title: Evaluation of the Impact of the Use of Hypnotherapy Performed by a Virtual Reality Tool Along the Care Pathway of Patients Undergoing Breast Cancer Treatment: Randomized Controlled Trial.

acronym: HYGEE

summary:
In 2017, it is estimated that nearly 60,000 new cases of breast cancer will be diagnosed in France. Although several treatments are indicated in this context, chemotherapy remains a curability option whose place today extends to small tumors to support its increasingly approved administration contributing to a continuous increase in survival rates.

However, diagnostic procedures and anti-cancer treatments are frequently responsible for toxicity that can reach high levels of severity and even generate sequelae.

These physical and psychological after-effects of breast cancer treatment have a short and medium-term impact on the quality of life of the patients treated: anxiety, fear, pain, job loss, and the onset of precariousness.

In addition, surgical procedures such as PAC and pic-line surgery are often associated with anxiety and pain. Chemotherapy is particularly associated with anxiety, stress, fatigue, nausea and vomiting.

Some immediate, delayed or even anticipated side effects are not always effectively controlled by the medication available to us. Anti-nausea medications can lead to drug interactions and/or other adverse effects. The interest of a non-drug approach is to get rid of these adverse effects. However, it is underestimated and therefore currently not integrated into current practice.

Its benefits must therefore be explored within the framework of in-depth research protocols that justify our study.

primary_purpose: Supportive Care


title: Evaluation of Post-vaccination Anti-SARS-CoV-2 Serological Response in Health Care Workers With a History of COVID-19.

acronym: VACCICOVID

summary:
Since the beginning of 2020, a major pandemic due to the new emerging coronavirus (SARS-CoV-2) has been spreading around the world. Today, the hope to contain this pandemic lies in the development and use of vaccines directed against this virus. Different strategies aim to maximize the early impact of vaccination in a context where few doses are available.

In early January 2021, large-scale vaccination began in France, first for populations at risk of severe COVID-19, but also for healthcare workers over 50 years of age or with an underlying pathology, and then for all voluntary healthcare workers.


title: Nutritional Care Influences Head Growth at Discharge in Extremely Low Birth Weight Infants.

acronym: KARLY

summary:
As extremely low birth weight infants are high-risk patients, the study aimed to compare neonatal care, nutritional strategy and postnatal growth of these infants in two European neonatal units. A retrospective study included extremely low birth weight infants born in Lyon, France or in Stockholm, Sweden. Data on morbidity, treatments, care practices, macro-nutrient intakes and postnatal growth were collected to determine risk factors of extra uterine growth restriction at discharge.

By comparing postnatal growth in ELBW infants hospitalized in two European neonatal intensive care units with different nutritional and extra nutritional care,our objective was to evaluate the role of nutrition in this population of preterm infants.

lead_sponsor: Hôpital de la Croix-Rousse


title: Non-interventional Study Evaluating Efficacy and Tolerance on TEAM Conditioning (Thiotepa/Etoposide/Aracytin/Melphalan) Followed by Autologous Haematopoietic Stem Cells Transplantation in Patients With Lymphoma

acronym: TEAM

summary:
Lymphoma is a malignant blood disease sensitive to chemotherapy. In case of relapse after first-line treatment, high-dose chemotherapy conditioning followed by autologous hematopoietic stem cell transplantation (auto-HSCT) improves patient survival and reduces the risk of relapse. Auto-HSCT may also be indicated in the first line in case of aggressive lymphoma at high risk of relapse. BEAM (Carmustine, Etoposide, Aracytine and Melphalan) is the more frequently used high-dose conditioning regimen. Nevertheless, Carmustine is no longer available in Europe.

The investigators have therefore chosen to replace Carmustine by Thiotepa and use the TEAM regimen as the new conditioning. Indeed, Thiotepa is approved by french national agency for the security of drugs (ANSM) for use as part of auto-HSCT conditioning regimen. The results of TEAM regimen in terms of efficacy and toxicity appear similar to those of BEAM. However, no study have been performed prospectively. Only small series and case reports have been reported.

If the study confirms the results of retrospective studies, conditioning by TEAM could become a new standard in auto-HSCT for the treatment of lymphoma.

This study is non-interventional, prospective with 3 centers.

All included patients will receive, according to standard practice and drug label in France, the following diagram:

Conditioning:

Thiotepa 8 mg / kg to J-6
Etoposide 100 mg / m² / 12 h for 4 days (J-5 to D-2)
Aracytine 200 mg / m² / 12 h for 4 days (J-5 to D-2)
Melphalan 140 mg / m² on day-1
Transfusion graft: the day D0 with autologous peripheral stem cell transplant
Care supports: Patients will be treated according to the usual procedures of centers participating in the study at the discretion of the investigator.
Follow-up of patients will not be changed by the study.

The main objective of the study is to evaluate the progression-free survival (PFS) of lymphoma patients treated with autologous stem cells after conditioning by TEAM

Secondary objectives are:

To evaluate overall survival;
To assess the response to treatment;
to evaluate the incidence of relapse;
to assess the toxic transplant related mortality;
to study transplant-related morbidity (infections, nutritional and gastrointestinal toxicity, immune reconstitution).

lead_sponsor: Association for Training, Education, and Research in Hematology, Immunology, and Transplantation


title: Prevalence of Autoantibodies in the Gaucher Disease and the Role of CD1 Molecules in Immune Manifestations of This Disease

summary:
Hypergammaglobulinaemia is frequently observed in type 1 Gaucher disease (GD1), being either polyclonal or monoclonal gammopathies. Polyclonal hypergammaglobulinemia may be related to the presence of autoantibodies. The clinical significance of such antibodies is questioned in Gaucher disease (GD), as some cases of immunologic thrombocytopenia and autoimmune hemolytic anemia have also been reported.

Objectives:

To evaluate the prevalence of autoantibodies and autoimmune diseases in GD1 patients, we conducted a multicenter national study. The investigators investigated whether there was a link between splenectomy, genotype, therapeutic options and the presence of these autoantibodies.They also investigated whether there was a correlation with some clinical manifestations of GD1

lead_sponsor: Hospital St. Joseph, Marseille, France

location_facility: Internal Medicine Department, Hôpital Beaujon,

location_facility: Internal Medicine Department, Hôpital Minjoz,

location_facility: Internal Medicine Department, Catholic University,

location_facility: Intensive Care Department, Hôpital Pellegrin,

location_facility: Internal Medicine Department, CHU la Pitié Salpêtrière,

location_facility: Internal Medicine and Immunology Department, CHU Hôpital Brabois,

location_facility: CHRU de Tours, Université François Rabelais, INSERM 1069,

location_facility: Internal Medicine Department, CHU, Nantes

location_facility: Internal Medicine and Rheumatology Department, Hôpital La Croix Saint Simon,

location_facility: Internal Medicine and Clinical Immunology Department, CHU,

intervention_type: Genetic


title: Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic: Retrospective and Prospective Multicentric Study.

acronym: COVID-EP

summary: The purpose of the study COVID-EP is to classify all the complications occurring after the diagnosis of pulmonary embolism in patients tested initially COVID-19 positive and negative by RT-PCR (on nasopharyngeal sample) during the peak of the pandemic in France (April 2020). The patients will be followed for 1 year in order to provide clinical and paraclinical data not yet published in the literature. In order to secondarily confirm the COVID-19 status of initially negative COVID-19 patients (by RT-PCR), a serology test will be performed. The collected complications will then be compared between each of the 3 following groups: [PCR-COVID 19-Neg & Sero-COVID 19-Neg] versus [PCR-COVID 19-Neg & Sero-COVID 19-Pos] versus [PCR-COVID 19-Pos].

intervention_type: Diagnostic Test


title: Evaluation of Post-operative Respiratory Complications After Thoracic Surgery in Patients With COPD

summary:
Evaluation of post-operative respiratory complications after thoracic surgery for pulmonary resection in patients with COPD

Introduction: Postoperative pulmonary complications following pulmonary resection occur in 12-40% of cases. Some risk factors such as COPD are well identified. It has been shown that COPD patients with a history of frequent exacerbations are more likely to develop exacerbations. No study has evaluated the rate of patients called 'frequent exacerbators' among COPD patients requiring pulmonary resection and the relations between exacerbations history and incidence of acute respiratory postoperative complications.

The main objective is to determine the frequency of pulmonary postoperative complications (atelectasis, acute respiratory failure, pneumonia) following lung resection in COPD patients. The secondary objectives are to determine the frequency of extra pulmonary postoperative complications and the prevalence of the 'frequent exacerbator' phenotype in this population, as well as its relation with the risk of post-operative complications.

Materials and Methods: This is a prospective, observational, single-center study, of patients with COPD hospitalized for elective thoracic surgery in the center of Thoracic Surgery, Hôpital Cochin. The inclusion criteria are: male or female aged more than 40 years, permanent airflow obstruction as defined by an FEV/FVC ratio < 70% after bronchodilator. Collected data will be: COPD symptoms (dyspnea score, exacerbations) by a questionnaire given to the patient during the anesthesia consultation, COPD severity scores, comorbidities, per operative data, postoperative complications, hospitalization and intra-hospital mortality.

Perspectives: This work will provide information on the risk of postoperative complications in patients with COPD and the influence of the 'frequent exacerbator' phenotype. This will help adapting preventive care to the COPD subtype .

ReferenceCitation: Hurst JR, Vestbo J, Anzueto A, Locantore N, Müllerova H, Tal-Singer R, Miller B, Lomas DA, Agusti A, Macnee W, Calverley P, Rennard S, Wouters EF, Wedzicha JA; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med. 2010 Sep 16;363(12):1128-38. doi: 10.1056/NEJMoa0909883.

ReferenceCitation: Wedzicha JA, Seemungal TA. COPD exacerbations: defining their cause and prevention. Lancet. 2007 Sep 1;370(9589):786-96. Review.

ReferenceCitation: Wan ES, DeMeo DL, Hersh CP, Shapiro SD, Rosiello RA, Sama SR, Fuhlbrigge AL, Foreman MG, Silverman EK. Clinical predictors of frequent exacerbations in subjects with severe chronic obstructive pulmonary disease (COPD). Respir Med. 2011 Apr;105(4):588-94. doi: 10.1016/j.rmed.2010.11.015. Epub 2010 Dec 10.

family: Wan

full_name: Emily S. Wan

given: Emily S.

family: DeMeo

full_name: Dawn L. DeMeo

given: Dawn L.

family: Hersh

full_name: Craig P. Hersh

given: Craig P.

family: Shapiro

full_name: Steven D. Shapiro

given: Steven D.

family: Rosiello

full_name: Richard A. Rosiello

given: Richard A.

family: Sama

full_name: Susan R. Sama

given: Susan R.

family: Fuhlbrigge

full_name: Anne L. Fuhlbrigge

given: Anne L.

family: Foreman

full_name: Marilyn G. Foreman

given: Marilyn G.

family: Silverman

full_name: Edwin K. Silverman

given: Edwin K.

journal_name: Respiratory Medicine

oa_colors: green other

version: acceptedVersion

lead_sponsor: Hôpital Cochin

location_facility: Réanimation chirurgicale thoracique Hôpital Cochin


title: Evaluation of METAglut1 Diagnostic Test Performances in Patients With a Clinical Suspicion of GLUT1 Deficiency Syndrome

summary:
The study aims at validating the diagnostic performances of the METAglut1, a blood in vitro diagnostic test, for the simple and early diagnosis of the GLUT1 deficiency syndrome (GLUT1DS, or De Vivo disease).

The blood test will be carried out prospectively on patients presenting with a clinical suspicion of GLUT1DS, blindly from the reference strategy, which consists in a lumbar puncture for glycorrhachia measurement, completed by a molecular analysis.

The study will be conducted in more than 40 centers in France on up to 3,000 patients for 2 years.

ReferenceCitation: Gras D, Cousin C, Kappeler C, Fung CW, Auvin S, Essid N, Chung BH, Da Costa L, Hainque E, Luton MP, Petit V, Vuillaumier-Barrot S, Boespflug-Tanguy O, Roze E, Mochel F. A simple blood test expedites the diagnosis of glucose transporter type 1 deficiency syndrome. Ann Neurol. 2017 Jul;82(1):133-138. doi: 10.1002/ana.24970.

lead_sponsor: METAFORA biosystems

location_facility: Hôpital Gui de Chauliac- CHU Montpellier

location_facility: Hôpital de la mère et de l'enfant- CHU Limoges

location_facility: Centre hospitalier Pellegrin_ CHU Bordeaux


title: Retrospective Clinical Study of the Care and Follow-up in the First Month of Life of Newborns in Level III Services in Alsace From Mothers With COVID-19

acronym: COVID-Néo

summary:
Very little is known about the impact on the newborn of late pre-partum maternal SARS-CoV-2 infection.

Care without separation of the mother and her newborn with continued breastfeeding has been advocated in France and by the WHO but is being debated in some countries.

Assessment of the development of newborns in their first month of life with this strategy associated with close and secure follow-up.

Importance of reporting the potential benefits / risks of this treatment to guide the care of newborns in a persistent epidemic context in a particularly affected region.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service de Médecine et Réanimation du Nouveau-né - Hôpitaux Universitaires de Strasbourg


title: Proof-of-concept Study for a New Intraocular Lens, MODEL C0001

summary:
This study is a 12-month, prospective, 2-arm (1 test & 1 control), randomized (1 test:1 control), bilateral, subject/evaluator-masked clinical investigation of the EPV IOL versus the standard TECNIS monofocal control IOL.

The study will be conducted at a minimum of one to a maximum of five sites in France, with a total of 40 evaluable subjects for the investigational lens group and 40 evaluable subjects for the control lens group participating in the sub-study. The peripheral and functional testing will be conducted on a sub-group of subjects who achieve binocular uncorrected distance visual acuity (UCDVA) of 0.2 logMAR or better and/or are able to perform the driving simulator-sickness testing as determined by patient response to the SSQ (Appendix D) at the first 1-month visit.

The eye implanted first will be considered the primary study eye (first eye). Subjects will be randomized to either the investigational IOL Model C0001 or the control IOL Model ZCB00 in both eyes.

ipd_sharing: Yes

ipd_sharing_description: Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu

lead_sponsor: Johnson & Johnson Surgical Vision, Inc.

location_facility: Centre Hospitalier National d'Ophtalmologie


title: Nervous System Infections Among Patients With Febrile Seizure : Retrospective Cohort Review of Consecutive Patients Admitted in 7 Pediatric Emergency Departments in Ile-de-France Between 2007 and 2011

summary:
Few studies dealing with the risk of infectious of nervous system and the utility of lumbar puncture and of emergent neuroimaging among patients with simple febrile seizure between 3 and 11 months age and with complex seizure has been reported. None of these studies was multicentric. Recommendations about management of these children are heterogeneous.

The investigators aim to study by an observational retrospective multicentric study the rate of infectious of central nervous system among patients with a complex febrile seizure and among patients between 3 and 11 months age with simple febrile seizure.

lead_sponsor: Hôpital Armand Trousseau

location_facility: Centre hospitalier intercommunal de Poissy

location_facility: Centre hospitalier intercommunal de creteil

location_facility: Centre hospitalier Lagny-Marne la Vallée


title: Role of Mitochondrial Dysfunction in the Occurrence of Acute Kidney Injury(AKI) in Postoperative Cardiac Surgery

acronym: MIT-CEC

summary:
Cardiac Surgery and Acute Kidney Failure (AKI) post Surgery:

AKI is a frequent complication in the immediate aftermath of cardiac surgery with an incidence varying from 5 to 40%. KDIGO criteria (Kidney Disease: Improving Global Outcomes) are used to define the AKI in cardiac surgery because of their validated prognostic value in this patient population. The occurrence of a postoperative AKI, even of low severity, is accompanied by a significant increase in the duration of hospitalization and mortality. The AKI risk factors in cardiac surgery are related to the precarious clinical conditions of the patient before the surgery, to the complex surgical context, to the surgical procedures particularly the duration of extracorporeal circulation (ECC) greater than 120 min and the occurrence of a postoperative circulatory insufficiency.

AKI and inflammatory response:

The mechanisms involved in postoperative AKI in cardiac surgery, are low cardiac output, ischemia reperfusion injury (IRI), mechanical intravascular hemolysis, hypothermia, and activation of the neuroendocrine system by the ECC.

In addition, ECC triggers a secondary inflammatory response to blood contact with the ECC circuit and membranes. The secondary stimulation of immunocompetent cells accompanies secretion of many cytokines and proinflammatory mediators via the activation of nuclear transcription factors as the NFκB factor.

Of the 50 000 ECC performed per year in France, about 25% of the patients develop a Systemic Inflammatory Response Syndrome (SIRS). Although most often transient, SIRS can intensify and lead to a multi-visceral failure and to death, especially if the patient presents medical history of type 2 diabete. Increase of postoperative plasma cytokine levels has a positive predictive value on the occurrence of AKI and the risk of death.

Priming of the NLRP3 inflammasome and post ECC inflammatory response:

In addition to activation by nuclear transcription factors (NFκB), the inflammatory syndrome may develop secondarily to the activation of multi-protein platforms, called inflammasomes.

The activation of the NLRP3 inflammasome has been particularly studied in humans because of its association with multiple chronic inflammatory pathologies, infectious and cardio-metabolic diseases. Its activation is the combination of intracellular receptors like NOD-like receptors (NLR) types, ASC-like adapter proteins and pro caspase-1.

This assembly activates inflammatory caspases (caspase-1, in particular) responsible for the cleavage of pro-interleukins IL-1β and IL-18 in mature pro-inflammatory cytokines that participate in the orchestration of the inflammatory response.

Activation of the NLRP3 inflammasome requires prior priming which allows increase of NLRP3 and pro-cytokines IL1β and IL18 expressions. This priming is particularly intense in the presence of a mitochondrial dysfunction and of an increase in reactive oxygen species (ROS). Next, the activation of the NLRP3 inflammasome may be secondary to the presence of danger signals from cellular damages, such as cellular and mitochondrial debris (including mitochondrial DNA) recognized by NLRP3 receptors. Thus, preoperative mitochondrial dysfunction and its postoperative aggravation by ECC due to IRI induced by ECC represents powerful signals ,of the NLRP3 inflammasome activation.

Research hypothesis:

The hypothesis is that the preoperative priming of the NLRP3 inflammasome by a preoperative mitochondrial dysfunction is a factor favoring the occurrence of postoperative AKI after cardiac surgery with ECC.

For type 2 diabetic patients, the investigators think that preoperative mitochondrial dysfunction (mitochondrial respiration abnormalities and hyperpermeability of mitochondrial membranes) is accentuated worsening IRI induced by the ECC.

This increases postoperative release of cells and mitochondrial debris that maintain the activation of the NLRP3 inflammasome, exacerbating the inflammatory response and favoring the occurrence of AKI.

ReferenceCitation: Zakkar M, Ascione R, James AF, Angelini GD, Suleiman MS. Inflammation, oxidative stress and postoperative atrial fibrillation in cardiac surgery. Pharmacol Ther. 2015 Oct;154:13-20. doi: 10.1016/j.pharmthera.2015.06.009. Epub 2015 Jun 24. Review.

ReferenceCitation: Corral-Velez V, Lopez-Delgado JC, Betancur-Zambrano NL, Lopez-Suñe N, Rojas-Lora M, Torrado H, Ballus J. The inflammatory response in cardiac surgery: an overview of the pathophysiology and clinical implications. Inflamm Allergy Drug Targets. 2015;13(6):367-70. Review.

ReferenceCitation: Hoste EAJ, Vandenberghe W. Epidemiology of cardiac surgery-associated acute kidney injury. Best Pract Res Clin Anaesthesiol. 2017 Sep;31(3):299-303. doi: 10.1016/j.bpa.2017.11.001. Epub 2017 Nov 8. Review.

ReferenceCitation: Wang Y, Bellomo R. Cardiac surgery-associated acute kidney injury: risk factors, pathophysiology and treatment. Nat Rev Nephrol. 2017 Nov;13(11):697-711. doi: 10.1038/nrneph.2017.119. Epub 2017 Sep 4. Review.

ReferenceCitation: Patel SS, Palant CE, Mahajan V, Chawla LS. Sequelae of AKI. Best Pract Res Clin Anaesthesiol. 2017 Sep;31(3):415-425. doi: 10.1016/j.bpa.2017.08.004. Epub 2017 Sep 6. Review.

ReferenceCitation: O'Neal JB, Shaw AD, Billings FT 4th. Acute kidney injury following cardiac surgery: current understanding and future directions. Crit Care. 2016 Jul 4;20(1):187. doi: 10.1186/s13054-016-1352-z. Review.

ReferenceCitation: Ortega-Loubon C, Fernández-Molina M, Carrascal-Hinojal Y, Fulquet-Carreras E. Cardiac surgery-associated acute kidney injury. Ann Card Anaesth. 2016 Oct-Dec;19(4):687-698. doi: 10.4103/0971-9784.191578. Review.

ReferenceCitation: Rheinheimer J, de Souza BM, Cardoso NS, Bauer AC, Crispim D. Current role of the NLRP3 inflammasome on obesity and insulin resistance: A systematic review. Metabolism. 2017 Sep;74:1-9. doi: 10.1016/j.metabol.2017.06.002. Epub 2017 Jun 11. Review.

ReferenceCitation: Próchnicki T, Latz E. Inflammasomes on the Crossroads of Innate Immune Recognition and Metabolic Control. Cell Metab. 2017 Jul 5;26(1):71-93. doi: 10.1016/j.cmet.2017.06.018. Review.

ReferenceCitation: Feldman N, Rotter-Maskowitz A, Okun E. DAMPs as mediators of sterile inflammation in aging-related pathologies. Ageing Res Rev. 2015 Nov;24(Pt A):29-39. doi: 10.1016/j.arr.2015.01.003. Epub 2015 Jan 29. Review.

ReferenceCitation: Traba J, Sack MN. The role of caloric load and mitochondrial homeostasis in the regulation of the NLRP3 inflammasome. Cell Mol Life Sci. 2017 May;74(10):1777-1791. doi: 10.1007/s00018-016-2431-7. Epub 2016 Dec 10. Review.

lead_sponsor: University Hospital Center of Martinique


title: Salvage HIFU for Local Recurrence in the Prostatic Bed After Prostatectomy and External Beam Radiation Therapy : Preliminary Results

acronym: Salvage HIFU

summary: Retrospective monocentric analysis performed on patients treated with salvage HIFU for isolated macroscopic recurrence in the prostatic bed after radical prostatectomy and salvage or adjuvant EBRT. The oncological outcomes (treatment failure-free survival, progression-free survival), the adverse events and urinary incontinence will be evaluated.

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of Urology and Transplantation Surgery, Edouard Herriot Hospital,


acronym: PRADO-IC

summary:
Heart failure (HF) is a serious chronic disease with frequent readmissions, some of which can be prevented by early action. The management of HF is complex: long, often difficult and costly. In France, nearly one million people suffer from HF and 120,000 new cases are diagnosed every year. With the aging population, this number will continue to evolve and become a real public health problem. Within 10 to 20 years ahead, WHO projects that heart failure in either the 3 most common diseases in industrialized countries.

Investigators goals are to make an inventory of PRADO-IC project in terms of its effectiveness on readmission of patients with heart failure.

location_facility: Service de Médecine Interne, diabète et maladies métaboliques - Médicale B


title: Impact of Burden in Caregivers of Patients Hospitalized for a Psychotic Episode: a Multicenter Study

acronym: AFP

summary:
Family support is a positive predictor for psychiatric patients. For example, since the 1980s, it has been shown that family psychoeducation improves patient adherence to care and statistically decreases patient relapse and hospitalization rates by half, resulting in lower care costs. Yet, the stress of hospitalizing a patient, seeing the feelings of shame or guilt of caregiver and the impact on their quality of life are rarely taken into account by caregivers during the first weeks hospitalization in a patient's psychiatry.

Barrelet emphasizes the importance of organizing the meeting in the first hours of hospitalization with the family in order to strengthen the alliance, to improve communication.


title: Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study

acronym: TMS/DEP

summary:
number of center : 1

duration of study : 24 months
recruitement time : 23 months
Aim :Principal

Evaluate the interest of maintenance rTMS in a one-year double blind randomized controlled study for TRD patients.

Secondary

Evaluate the impact of rTMS on cognitive functions.


title: French National Observatory of the Patients With Non-small Cell Lung (NSCLC) Benefiting From a Molecular Test on the Hospital Platforms of Molecular Genetics.

summary:
The French National Cancer Institute (INCa) support a 28 hospital platforms network for molecular testing of cancer patients. These platforms routinely assess a panel of biomarkers in order to speed up access of French cancer patients to targeted therapies (commercially available or through clinical trials).

The objective of the BIOMARKERS-France study is to describe the epidemiological, clinical and molecular characteristics of these patients and their tumors and to assess the impact of these analyzes on their treatment (ie bio-guided therapy) as well as outcomes (response rate, progression free and overall survival).

ReferenceCitation: Barlesi F, Mazieres J, Merlio JP, Debieuvre D, Mosser J, Lena H, Ouafik L, Besse B, Rouquette I, Westeel V, Escande F, Monnet I, Lemoine A, Veillon R, Blons H, Audigier-Valette C, Bringuier PP, Lamy R, Beau-Faller M, Pujol JL, Sabourin JC, Penault-Llorca F, Denis MG, Lantuejoul S, Morin F, Tran Q, Missy P, Langlais A, Milleron B, Cadranel J, Soria JC, Zalcman G; Biomarkers France contributors. Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT). Lancet. 2016 Apr 2;387(10026):1415-1426. doi: 10.1016/S0140-6736(16)00004-0. Epub 2016 Jan 15.

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Mazieres

full_name: Julien Mazieres

given: Julien

family: Merlio

full_name: Jean-Philippe Merlio

given: Jean-Philippe

family: Debieuvre

full_name: Didier Debieuvre

given: Didier

family: Mosser

full_name: Jean Mosser

given: Jean

family: Lena

full_name: Hervé Lena

given: Hervé

family: Ouafik

full_name: L'Houcine Ouafik

given: L'Houcine

family: Besse

full_name: Benjamin Besse

given: Benjamin

family: Rouquette

full_name: Isabelle Rouquette

given: Isabelle

family: Westeel

full_name: Virginie Westeel

given: Virginie

family: Escande

full_name: Fabienne Escande

given: Fabienne

family: Monnet

full_name: Isabelle Monnet

family: Lemoine

full_name: Antoinette Lemoine

given: Antoinette

family: Veillon

full_name: Rémi Veillon

given: Rémi

family: Blons

full_name: Hélène Blons

given: Hélène

family: Audigier-Valette

full_name: Clarisse Audigier-Valette

given: Clarisse

family: Bringuier

full_name: Pierre-Paul Bringuier

given: Pierre-Paul

family: Lamy

full_name: Régine Lamy

given: Régine

family: Beau-Faller

full_name: Michèle Beau-Faller

given: Michèle

family: Pujol

full_name: Jean-Louis Pujol

given: Jean-Louis

family: Sabourin

full_name: Jean-Christophe Sabourin

given: Jean-Christophe

family: Penault-Llorca

full_name: Frédérique Penault-Llorca

given: Frédérique

family: Denis

full_name: Marc G Denis

given: Marc G

family: Lantuejoul

full_name: Sylvie Lantuejoul

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - TEL - Thèses en ligne

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

ReferenceCitation: Tomasini P, Brosseau S, Mazières J, Merlio JP, Beau-Faller M, Mosser J, Wislez M, Ouafik L, Besse B, Rouquette I, Debieuvre D, Escande F, Westeel V, Audigier-Valette C, Missy P, Langlais A, Morin F, Moro-Sibilot D, Zalcman G, Barlesi F. EGFR tyrosine kinase inhibitors versus chemotherapy in EGFR wild-type pre-treated advanced nonsmall cell lung cancer in daily practice. Eur Respir J. 2017 Aug 10;50(2). pii: 1700514. doi: 10.1183/13993003.00514-2017. Print 2017 Aug.

title: EGFR tyrosine kinase inhibitorsversuschemotherapy inEGFRwild-type pre-treated advanced nonsmall cell lung cancer in daily practice

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Clinique Calabet - Centre de Radiothérapie et d'Oncologie

location_facility: Lyon - Hôpital Louis Pradel (Pneumologie)

location_facility: Chambray Les Tours - Clinique Léonard de Vinci


title: Evaluation of Calcium Homeostasis and Mitochondrial Function in Skeletal Muscle in Subjects With Heart Failure, Before and After Exercise Training

acronym: Calcicard

summary:
The aim of this project is to investigate the impact of heart failure (HF) on calcium homeostasis, mitochondrial function and oxidative stress in human skeletal muscle, before and after exercise training. The role playing by circulating factors such as cytokines and catecholamines will also be evaluated.

24 HF patients will be enrolled in the study: 12 class II NYHA HF volunteers with a fraction of ejection between 40% and 30 %, and 12 class III NYHA HF volunteers with a fraction of ejection lower than 30 %. They will be compared to 24 sedentary healthy volunteers, matched on age and physical activity.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: Centre Hospitalier Régional Universitaire


title: Randomized Controlled Trial Comparing Botulin Toxin Versus Hyaluronic Acid by Intra-articular Injection for the Treatment of Painful Knee Osteoarthritis

acronym: GOTOX

summary:
In France, osteoarthritis affects about 10 million people and knee osteoarthritis represents 35% of cases. It is thought that more than 2.5 million people older than 65 years have knee osteoarthritis.

Currently, osteoarthritis management is based on three major axes:

Non-pharmacological means, such as patient education, loss of weight and physical activity
General pharmacological treatments: mainly paracetamol and then schedule II and III painkillers as well as nonsteroidal anti-inflammatory agent.

Intra-articular pharmacological treatments:

Intra-articular injections of corticosteroids: they are recommended during hydarthrotic flare-ups
Intra-articular injections of hyaluronic acid (HA) (viscosupplementation) in the absence of intra-articular effusion. However, their efficacy is questioned by most experts in the case of symptomatic knee osteoarthrosis.
Sometimes, surgery is the only therapeutic option. However, besides the fact of exposing patients, who are sometimes frail, to several peri- and post-operative complications, the recovery rate (variable according to the prosthesis type and ranging from 5% to 25% at 9 years) in an ageing population justifies waiting as much as possible before surgery. Therefore, it is important to test new therapeutic options for symptomatic osteoarthrosis that will allow postponing the surgical treatment.
The use of botulinum toxin (BoNT-A) could thus represents an interesting alternative. BoNT-A is habitually used by intra-muscular injection for its myorelaxant effect in the management of painful reactive periarticular muscle contractures. However, BoNT-A has also antalgic activity independently of the myorelaxant effect. This allows explaining in part the antalgic effect of intra-articular BoNT-A injection. In the literature, six randomized controlled studies (RCS) have compared BoNT-A and intra-articular injections of corticosteroids, hyaluronic acid, or placebo. Only two RCS concerned knee osteoarthritis and compared BoNT-A to corticosteroids and a placebo, respectively, with a significant antalgic effect only in the groups treated with BoNT-A. No study has compared yet the intra-articular injection of BoNT-A to the viscosupplementation by HA in knee osteoarthritis and this is the aim of this trial.


title: Links Between Depression, Anxiety, Coping and Quality of Life After a Stroke: Depressive and Anxiety Symptoms and Individual Coping Strategies of the Acute Phase in the Fourth Month as a Factor Influencing Mental Health and Quality of Life

acronym: COPING

summary:
Introduction and literature review With 130 000 cases per year in France in 2010, stroke is one of the most common neurological diseases, often leaving many disabling sequelae physical and cognitive levels (currently live 500 000 disabled following a stroke) and leading and a loss of significant autonomy in these patients. However, many stroke survivors soon find a range comparable to their previous state. Investigators can then ask ourselves about the impact of this life event in these people who apparently do not show visible effects: what about the psychological repercussions of stroke in these patients healthy; what is changed in their daily lives, particularly in their mental functioning after this brutal confrontation with their own mortality?

Objectives Our project aims to better understand the psychological repercussions of stroke in patients who quickly find a health and autonomy comparable to their previous state. The objective will be to investigate the relationship between depressive symptoms and anxiety, coping strategies and quality of life from the acute phase and during the first months after the onset of stroke. This period is particularly demanding for these patients must therefore adapt and readjust continuously: shock stroke, hospitalization in several services (intensive care, neurology, rehabilitation), back home, "new" life with the changes related stroke, resumption of a professional activity, etc ...

Our methodology will combine tools conventionally used (standardized interview, validated questionnaires) to newer, ecological and true methods (Experience Sampling Method applied by the use of a smarphone application) to assess different variables studied.

This initially be determined whether the various symptoms of the depression on the one hand and anxiety on the other hand, depending on their mode of expression (vs. outsourced internalized; ie emotional, cognitive, somatic), observed from the acute phase of stroke, are related and predict the quality of life, depression and anxiety in the longer term (four months after the stroke).

Furthermore, our study will observe if the individual coping strategies (coping) daily and evolution influence the psychological status and quality of life during the months following the stroke.

primary_purpose: Basic Science

ReferenceCitation: Alpers GW. Ambulatory assessment in panic disorder and specific phobia. Psychol Assess. 2009 Dec;21(4):476-85. doi: 10.1037/a0017489. Review.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility: Groupe Hopitalier Paris Saint Joseph Service de neurologie


title: Assessment of Age-related Hearing Loss in HIV-1 Patients

acronym: HELO

summary:
The ageing process is known to be accelerated in HIV-infected patients, compared to the general population.

Normal age-related hearing loss (presbyacusia) is a frequent phenomenon, affecting more than 70% of people above 65 years. It is believed to be mostly the consequence of a mitochondrial damage caused by oxidative stress.

Risk factors for accelerated age-related hearing loss are present in many HIV-infected patients : chronic inflammation, smoking, diabetes, etc.

The global aim is to measure the prevalence of presbyacusia in a well controlled HIV positive population in France, and to compare it to HIV negative controls matched for age and sex.

90 HIV positive patients and 90 age- and sex- matched HIV negative controls will undergo a screening for presbyacusia (pure-tone, speech and evoked-response audiometry).

We expect to find an increased prevalence of presbyacusia in HIV-infected patients, as compared to controls matched for age and sex.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Evaluation of the Impact of the Epidemic of COVID-19 Infection Among People Living With HIV (SARS-CoV-2)

summary: The non-essential and non-urgent follow-up consultations of patients living with HIV were postponed or transformed into "teleconsultation" or exchanges of e-mails between practitioners and patients during COVID-19 epidemic. This change in care can have an impact on follow-up and access to treatment for PVVIH.

lead_sponsor: Tourcoing Hospital

location_facility:
CHU Amiens Picardie
CH Lens
CH Tourcoing


title: Abatacept Versus Tocilizumab by Subcutaneous Administration for the Treatment of Rheumatoid Arthritis in TNF Alpha Inhibitor Inadequate Responder Patients: A Randomized, Open-labeled, Superiority Trial

acronym: SUNSTAR

summary:
Rheumatoid arthritis (RA) is the most common inflammatory rheumatoid disease in France, affecting 0.3% of the general population. Without effective treatment, the persistent inflammation causes invalidating pain and joint destruction, leading to major functional disability.

Biological agents have been proposed for patients with RA who have the most severe form of the disease and that are inadequate responder patients to conventional synthetic Disease-modifying antirheumatic drugs (csDMARDs). TNF inhibitors (TNFi) are historically proposed as the first biological DAMRD for inadequate responder patients to csDMARDs. A diverse therapeutic arsenal has become available in recent years with the development of non-anti-TNFα drugs whose mechanisms of action are different from the classical TNFi. This new biotherapy class includes tocilizumab and abatacept, two drugs recently available for subcutaneous administration that enables ambulatory care for patients who would otherwise require repeated in-hospital care.

The role of these new treatments in the therapeutic strategy has been emphasized by studies that demonstrated their efficacy as first-line treatments. However, in clinical practice, TNFi remain the most common first-line treatment for the majority of patients, non-anti-TNFα biological agents being reserved for inadequate responder patients.

In second line, several studies have investigated therapeutic strategies for inadequate responder patients to TNFi. Current data suggest that it could be wise to change the therapeutic target after failure of a first-line treatment with TNFi.

Data about the comparative efficacy of different biologics proposed after failure of a first-line treatment with TNFi are in progress. Meta-analyses from registries and academic trials conducted in France and The Netherlands suggest that non-anti-TNFα agents would have equivalent or superior efficacy compared with a second TNFi. This finding suggests clinicians to switch for an alternate therapeutic target after failure of a first-line TNFi.

Data comparing different non-anti-TNFα biologics in inadequate responder patients to TNFi are scare. Industrial trials have demonstrated sustained biological efficacy of non-anti-TNFα biologics after failure of a TNFi. However, there is very little solid data on the direct comparison between them.

lead_sponsor: Lille Catholic University


title: Immunological Follow-up After COVID 19 Vaccination in Kidney Transplant Recipients

acronym: COVATRHUS

summary:
The investigators goal is to assess the vaccine response of kidney transplant patients following vaccination against SARS-CoV-2.

The study population will be derived from cohorts of kidney transplant patients who have been transplanted for more than 3 months and have no contraindications to vaccination. These patients will be vaccinated as part of routine care with a CoV-2 SARS vaccine licensed in France.

In this cohort, the investigators wish to study the post-vaccination humoral response by assaying neutralizing antibodies against SARS CoV-2 and the specific cellular response of SARS Cov-2 by quantiferon and in vitro lymphocyte stimulation assays.


title: Cohort of the French Clinical Research Network for Parkinson's Disease (NS-PARK Cohort)

acronym: NS-PARK

summary: The aim of NS-PARK cohort are to describe the natural history of Parkinson's disease (PD), and to propose patients stratification models based on PD pathophysiological mechanisms. Patients are included at all PD expert centers in France. Standardized demographic, diagnosis, motor and non-motor symptoms evaluation, and treatment information are collected, and clinical data are updated at each visit of the patient at the center. A blood sampling is perform at baseline for genetic testing and implement an associated biocollection.


title: EVENDOL Scale Validation for at Term New-born

summary:
Maternity and neonatology, caregivers are regularly confronted with the pain of the newborn, especially after a birth injury, but it is sometimes difficult ti define.

There is not, to our knowledge, any prevalence study of pain in newborn motherhood. The data available are those of the perinatal survey 2010, with the number of operative vaginal deliveries (5.3% of suction, forceps 3.9%, 2.9% spatulas) and the number of extractions the seat (4.7%). These delivery modes can be purveyors of pain.

At St. Joseph's Hospital, there were in 2013: 259 instrumental deliveries and 90 extractions by headquarters. Fifty five paracetamol bottles were consumed in the layer sequence in 2013, and 15 in the delivery room. But this consumption is a poor reflection of the pain because treatment could be given pain-authenticated (measured with the EDIN scale), and because a bottle is discarded one month after opening.

The scales measuring pain used in the new-born at term based on the assessment of change in behavior; two specific scores of the newborn are used in France: Pain and Discomfort Scale Newborn (EDIN) for prolonged pain and Acute Pain scale Newborn (DAN) for acute pain related to health care.

The EVENDOL scale (Child Pain Evaluation) has been validated for pediatric emergencies in children 0-7 years, as well as pre-hospital, to measure the intensity of pain whether acute or prolonged (8 ). It is easy and fast to use. validation cohorts included a significant proportion of newborns. This scale appears suitable for evaluation of the newborn to term maternity

location_facility:
Groupe Hospitalier Paris Saint Joseph
Hôpital Armand Trousseau