title: Impact of the Covid19 Pandemic on the Organization of Healthcare in France

acronym: IRIS

summary:
The 2020 COVID-19 pandemic, which began spreading on January 24, 2020 in France, has required a profound and rapid reorganization of the health system, based in particular on internal hospital reorganizations of front-line establishments, deprogramming of non-urgent activities, and transfers of non-covid19 patients to 2nd line facilities. Beyond the immediate impact on the management of patients infected with COVID-19, this reorganization may have reduced the capacity of management for patients requiring urgent or semi-urgent intervention, or may have postponed some necessary care. The isolation of patients at home may also have resulted in lower compliance to therapy and medical treatments and may have contributed to decompensation.

At the end of this crisis, the different organizational responses in France should be evaluated to identify the consequences and the areas for improvement in order to be prepared for future exceptional health situations. This investigation on healthcare systems confronted to an exceptional health situation thus seeks to determine if the profound reorganizations implemented during this health crisis have indirect effects on the performance of care, in particular if there is a destabilization of the care systems (emergency, semi-emergency and chronic), a loss of chance for the patients and if innovative care paths have emerged.

location_facility: Assistance Publique Hôpitaux de Marseille


title: Management of Venous Thromboembolism in France: a National Survey Among Vascular Medicine Physicians

acronym: Observ-MTEV

summary: In France, venous thromboembolic (VTE) disease is usually managed by vascular medicine physicians (VMP). The national OPTIMEV study, conducted more than 12 years ago among VMP practicing in hospital and in the community described the management of VTE in routine clinical practice. Since then a large number of practice changing studies have been published. This includes trials that have validated the use of direct oral anticoagulants (DOAC), the new standard of care of VTE, as per new national and international guidelines. Management of VTE in 2019 appears to be significantly different from the one that prevailed more than 10 years ago when the last national survey was conducted. It is therefore important to have an update on the routine clinical practice management of VTE by VMP. In this perspective the investigators aim to conduct a national survey among VMP practicing in France

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire, Amiens

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: Outcomes of Severe Osteoporotic Fractures Hospitalized in France: the CROSS Cohort

acronym: CROSS

summary: The purpose of this study is to determine the outcomes of severe osteoporotic fractures hospitalized in France, the risk of incident severe fracture at 2 years and 5 years and the risk of mortality over 2 and 5 years.

status: Active, not recruiting

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Estimation of Osteoporosis' Prevalence in France: Pilot Study in the Department of the Alpes-Maritimes

summary: The purpose of this study is to estimate Osteoporosis' prevalence in France and is a pilot study in the Department of the Alpes-Maritimes.

status: Completed

study_type: Interventional

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Procedure

status_simplified: Completed


title: " 7 Days Survey of Obstetric Analgesia/Anesthesia in France" (EPIDOL)

acronym: Epidol

summary:
Obstetric analgesia is a requirement of our times. The different applicable methods vary in effectiveness. The essential part is represented by epidural analgesia which remains one of the most effective methods. It is important to know other methods to respond to all requests. The applications of these methods, patient satisfaction and psychic experience, complications or incidents remain poorly or partially evaluated in France.

The main objective is to describe the different techniques of anesthesia/analgesia actually used in France for the management of pain during vaginal deliveries and cesarean sections on a representative sample of all maternity hospitals at a given time(7 days per maternity hospital, 63 maternity hospitals (levels I,II,III), so about 2500 births).

Secondary objectives will be multiple :

Describe the results of analgesic methods on the physical pain of patients during labor by a global visual analog scale
Describe the feeling of pregnant women relative to the different anesthesic and analgesic techniques, by an analysis of the questionnaire responses
Describe the frequency of adverse events of birth

status: Unknown status

lead_sponsor: Hospices Civils de Lyon

intervention_type: Other

status_simplified: Unknown


title: Follow-up Data of Patients Treated With XIGRIS® DROTRECOGIN ALFA (ACTIVATED) in France

summary:
The transparency commission wishes that the laboratory Lilly France sets up a follow-up study describing the conditions of use of Xigris® in France.

The purpose of this study is to describe the characteristics of the treated patients, the conditions of drug use, in particular the conditions of treatment initiation and the clinical development of the patients during normal clinical practice, in particular rate and cause of mortality within one month.

study_completion_date_type: Actual

lead_sponsor: Eli Lilly and Company

location_facility: For additional information regarding investigative sites for this study, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

lead_sponsor_type: industriel


title: Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France

summary:
No structured organization for ovarian first line management emerges in France. Management across France seems to depend on regional contexts.

Regions display no specific organization or delineate regional network for the ovarian cancer management or report centralized management revolving around referent centers. These different templates present a major problem in identifying differences, costs and benefit.

To deal with this issue the Investigators propose a health economic evaluation based on cost-effectiveness analyses, completed with a budget impact analysis. This study will investigate the cost-effective management of patients with initial ovarian cancer using databases representative of different parts of French territories.

time_perspective: Retrospective

lead_sponsor: Centre Leon Berard

location_facility:
Calvados registry
Oveval
Côte d'or registry


title: A Prospective Cohort of Healthcare Workers in France

acronym: ESPERES

summary: ESPERES is a national prospective e-cohort study providing a resource for collecting information on healthcare workers (HCWs) currently working in France. The overall goal of ESPERES is to develop the infrastructure necessary to create and engage a community of HCWs who may be eligible for participation in future research studies. ESPERES is set up to answer research questions, in the field of prevention for HCWs, prevention for their own health, that of their relatives, their colleagues, and users of the hospital. These research questions will be carried out in the context of specific subsequent studies. The first study that will be carried out is related to prevention against COVID-19, in particular vaccination against COVID-19 and more broadly on the COVID-19 pandemic.

ipd_sharing: Undecided


title: Epidemiology of Human Cytomegalovirus Excretion in the Saliva of Children Attending Nursery in France.

acronym: CrèchMV

summary: Direct DNA amplification, viral isolation and specific antibody measurement in saliva from children attending nursery in France Sample collection will be done by the pediatrician the nurse, or one of the authorized investigators of the study.

ReferenceType: derived

ReferenceCitation: Alain S, Garnier-Geoffroy F, Labrunie A, Montané A, Marin B, Gatet M, Grosjean J, Dufour V, Saugeras M, Postil D, Hantz S. Cytomegalovirus (CMV) Shedding in French Day-Care Centers: A Nationwide Study of Epidemiology, Risk Factors, Centers' Practices, and Parents' Awareness of CMV. J Pediatric Infect Dis Soc. 2020 Dec 31;9(6):686-694. doi: 10.1093/jpids/piz097.

name: National Reference Center for Herpesviruses, Limoges, France

name: Inserm U1092 University Limoges, Limoges, France

name: Bacteriology, Virology, Hygiene Department, CHU Limoges, Limoges, France

family: Alain

full_name: Sophie Alain

given: Sophie

sequence: first

family: Garnier-Geoffroy

full_name: Françoise Garnier-Geoffroy

given: Françoise

sequence: additional

name: Centre for Methodology and Data Management (Cebimer Department), CHU Limoges, Limoges, France

family: Labrunie

full_name: Anaïs Labrunie

given: Anaïs

name: Paediatrics Department, CHU Limoges, France

family: Montané

full_name: Amélie Montané

given: Amélie

name: General Directorate for Health, Paris, France

family: Marin

full_name: Benoit Marin

given: Benoit

family: Gatet

full_name: Martine Gatet

given: Martine

name: Biology Department, Chambery Hospital, Chambery, France

family: Grosjean

full_name: Jérôme Grosjean

given: Jérôme

name: Families and Early Childhood Directorate, Infantile Maternal Protection Department, Paris, France

family: Dufour

full_name: Véronique Dufour

given: Véronique

name: Center of Clinical Investigation Department, CHU Limoges, Limoges, France

family: Saugeras

full_name: Mathilde Saugeras

given: Mathilde

family: Postil

full_name: Deborah Postil

given: Deborah

family: Hantz

full_name: Sébastien Hantz

given: Sébastien

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of the Pediatric Infectious Diseases Society

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Cytomegalovirus (CMV) Shedding in French Day-Care Centers: A Nationwide Study of Epidemiology, Risk Factors, Centers’ Practices, and Parents’ Awareness of CMV

lead_sponsor: University Hospital, Limoges


title: Survey for the Initial Treatment of Hypothyroidism in France

acronym: ORCHIDEE

summary: This observational survey with prospective and/or retrospective follow-up is designed to study practices for the initial treatment of hypothyroidism in France without modifying subject treatment.

lead_sponsor: Merck KGaA, Darmstadt, Germany


title: Early Risk Stratification of Patient Hospitalized for SARS-CoV2 Infection: Critical COVID-19 France CCF

acronym: CCF

summary: The COVID-19 pandemic of SARS CoV2 (Severe Acute Respiratory Syndrome, COVID-19) infection, which is currently evolving in France, raises many questions about the clinical and biological profile of infected hospitalized patients. If certain biological factors like troponin, BNP (Brain Natriuretic Peptid), or clinical factors like cardiovascular history or oncological history are associated with a worse prognosis, available data comes from studies in Asia for the majority, or including a limited number of patients. Patient stratification remains a major issue for patient sorting and early referral of patients.

ReferenceCitation: Sutter W, Duceau B, Vignac M, Bonnet G, Carlier A, Roussel R, Trimaille A, Pommier T, Guilleminot P, Sagnard A, Pastier J, Weizman O, Giordano G, Cellier J, Geneste L, Panagides V, Marsou W, Deney A, Karsenty C, Attou S, Delmotte T, Ribeyrolles S, Chemaly P, Gautier A, Fauvel C, Chaumont C, Mika D, Pezel T, Cohen A, Potier L; Critical COVID-19 France Investigators. Association of diabetes and outcomes in patients with COVID-19: Propensity score-matched analyses from a French retrospective cohort. Diabetes Metab. 2021 Jul;47(4):101222. doi: 10.1016/j.diabet.2020.101222. Epub 2020 Dec 31.

family: Sutter

full_name: Willy Sutter

given: Willy

family: Duceau

full_name: Baptiste Duceau

given: Baptiste

family: Vignac

full_name: Maxime Vignac

given: Maxime

family: Bonnet

full_name: Guillaume Bonnet

given: Guillaume

family: Carlier

full_name: Aurélie Carlier

given: Aurélie

family: Roussel

full_name: Ronan Roussel

given: Ronan

family: Trimaille

full_name: Antonin Trimaille

given: Antonin

family: Pommier

full_name: Thibaut Pommier

given: Thibaut

family: Guilleminot

full_name: Pierre Guilleminot

given: Pierre

family: Sagnard

full_name: Audrey Sagnard

given: Audrey

family: Pastier

full_name: Julie Pastier

given: Julie

family: Weizman

full_name: Orianne Weizman

given: Orianne

family: Giordano

full_name: Gauthier Giordano

given: Gauthier

family: Cellier

full_name: Joffrey Cellier

given: Joffrey

family: Geneste

full_name: Laura Geneste

given: Laura

family: Panagides

full_name: Vassili Panagides

given: Vassili

family: Marsou

full_name: Wassima Marsou

given: Wassima

family: Deney

full_name: Antoine Deney

given: Antoine

family: Karsenty

full_name: Clément Karsenty

given: Clément

family: Attou

full_name: Sabir Attou

given: Sabir

family: Delmotte

full_name: Thomas Delmotte

given: Thomas

family: Ribeyrolles

full_name: Sophie Ribeyrolles

family: Chemaly

full_name: Pascale Chemaly

given: Pascale

location_facility: Lille Catholic Institute Hospital Group, Lille

location_facility: Georges Pompidou European Hospital (AP-HP)


title: Are Potentially Avoidable Hospitalizations a Good Measure of Access To Primary Care in France?

acronym: HPE-LR

summary:
Potentially Avoidable Hospitalizations (Pah) Are Studied As An Indirect Measure Of Access To Primary Care And Of The Interface Between Primary And Secondary Care. A Previous Work Unveils Considerable Geographic Variation In The Rate Of Pah In France And Suggest That Primary Care Organization Might Play A Role In This Variation. However, A Limitation Of This Work Lies In The Lack Of Data On Actual Primary Care Utilization.

The Aim Of This Study Is To Analyze The Role Of Primary Care In The Variation Of Potentially Avoidable Hospitalizations At the Zip Code Level, In The French Region Languedoc-Roussillon-Midi-Pyrénées.

The investigator will implement An Ecological Approach In Which The Geographic Variation In The Rate Of Pah Is Analyzed In The French Region Lrmp, Year 2014. Age- And Sex-Adjusted Rate Of Pah By Zip Codes (N=612) Is Modeled Using A Spatial Regression Model.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Montpellier


title: Impact of the COVID-19 Pandemic on Online Gambling in France and Sweden

acronym: CONGA

summary:
The coronavirus disease 2019 (COVID-19) pandemic represents a major threat to global health. Since the beginning of the COVID-19 epidemic, all eyes have been focused on the significant somatic complications of COVID-19, but the impact on behaviors, particularly those that can lead to addictive disorders, remains little studied. A set of factors could explain a change in gambling activities, both in number of gamblers and in intensity of practices, due to the pandemic. On the one hand, the reduction or even the interruption of sporting and horse racing competitions may induce a decrease in these activities (both online and offline). Moreover, the closure of certain gambling venues and travel restrictions may also lead to a decrease of offline gambling activities in general. On the other hand, gamblers who can no longer perform their usual gambling activity could refer to available online gambling activities (poker, lotteries, casinos, etc.). Moreover, the threat of a financial crisis, the negative impact on psychological well-being (due to social isolation, stress of being infected, etc.), and increased time spent freely online, could also very largely motivate an initiation or an exacerbation of the gambling activity, especially online and in people in a situation of vulnerability. Both in France and Sweden, the closing of sports and horse race events has led to a sharp decrease in sports and horse-race betting. In both countries, the increase in other gambling types, including illegal gambling, and their potential for gambling problems is a source of concerns for public health authorities. As a consequence, more research is promptly needed in this area.

The use of gambling tracking data, widely acclaimed in recent years in research on online gambling given its ecological nature, could allow observing longitudinally changes in online gambling practices (both the raw gambling activity and risky behaviors) and in the use of responsible gambling (RG) tools due to the pandemic. Moreover, the combination of French and Swedish data will allow comparing two countries with very distinct politics regarding the pandemics, i.e. a lockdown in France in March - May 2020 and then in November - December 2020 compared to no lockdown in Sweden. Finally, gambling in women is on the rise and women display specific gambling behaviors, especially in early stages of the online gambling practice. The project will include the investigation of gender specificities both in the investigation of the impacts of the pandemic and in the comparison of French and Sweden gambling behaviors. Age, type of gambling activity and country (France / Sweden) will also be taken into account.

lead_sponsor: Nantes University Hospital


title: COVID-19 Critically Ill Patients' Evolution After Medical Transport by Train From Paris Intensive Care Units to West of France Intensive Care Units

acronym: TOCCIP

summary: Since early 2020, France knows a sanitary crisis with a massive influx of COVID-19 patients admitted in Intensive Care Units (ICU). It led to a saturation of the French health system, especially in some geographic areas such as East of France or Paris region. Therefore, authorities decided to transfer some critically ill patients from these crowded ICUs to less busy regional ICUs. it was done for the first time by medical train transportation. Knowing that the investigators lack experience regarding this type of medical evacuation, regarding the high number of transferred patients, with such a logistic effort, the investigators decided to study this phase of the COVID-19 sanitary crisis in order to draw a feedback. So far, there are no data in the literature regarding this topic.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Rennes University Hospital

location_facility:
CHU Poitiers
CHU Tours


title: Prospective/Retrospective Multicenter Registry to Examine the Real-world Performance in France of the E-vita OPEN PLUS Stent Graft System

acronym: FEOR

summary: The FEOR registry is undertaken to examine the real-world data of patients that were treated with the E-vita OPEN Plus Stent Graft System under routine care in France. This registry is a requirement of the Haute Autorité de Santé (HAS).

lead_sponsor: JOTEC GmbH

location_facility: Rennes Pontchaillou University Medical Centre

location_facility: Clinique de l'Infirmerie Protestante à Lyon

intervention_type: Device


title: Evaluation of the Vaccination Coverage in a Prospective Cohort of Cirrhotic Patients Followed in the General Hospitals in France in 2021

acronym: VACCIR

summary: the purpose of this study is to estimate vacinal coverage against hepatitis A and B viruses, pneumococcus, diphtheria/tetanos and poliomyelitis, influenza virus and covid in cirrhotic patients followed in general hospitals of France and to show the

lead_sponsor: Centre Hospitalier Sud Francilien


title: Cabozantinib Real-life Use for Advanced Renal Cell Carcinoma in France: a Retrospective Descriptive Non-interventional Study of 2 Cohorts.

acronym: CABOREAL

summary: The primary objective of the study is to describe the real-life conditions of use and exposure of cabozantinib in France in two cohorts defined by their treatment initiation period.

ReferenceCitation: Albiges L, Fléchon A, Chevreau C, Topart D, Gravis G, Oudard S, Tourani JM, Geoffrois L, Meriaux E, Thiery-Vuillemin A, Barthélémy P, Ladoire S, Laguerre B, Perrot V, Billard A, Escudier B, Gross-Goupil M. Real-world evidence of cabozantinib in patients with metastatic renal cell carcinoma: Results from the CABOREAL Early Access Program. Eur J Cancer. 2021 Jan;142:102-111. doi: 10.1016/j.ejca.2020.09.030. Epub 2020 Nov 27.

family: Albiges

full_name: Laurence Albiges

given: Laurence

family: Fléchon

full_name: Aude Fléchon

given: Aude

family: Chevreau

full_name: Christine Chevreau

given: Christine

family: Topart

full_name: Delphine Topart

given: Delphine

family: Gravis

full_name: Gwenaëlle Gravis

given: Gwenaëlle

family: Oudard

full_name: Stéphane Oudard

given: Stéphane

family: Tourani

full_name: Jean M. Tourani

given: Jean M.

family: Geoffrois

full_name: Lionnel Geoffrois

given: Lionnel

family: Meriaux

full_name: Emeline Meriaux

given: Emeline

family: Thiery-Vuillemin

full_name: Antoine Thiery-Vuillemin

family: Barthélémy

full_name: Philippe Barthélémy

given: Philippe

family: Ladoire

full_name: Sylvain Ladoire

given: Sylvain

family: Laguerre

full_name: Brigitte Laguerre

given: Brigitte

family: Perrot

full_name: Valérie Perrot

given: Valérie

family: Billard

full_name: Anaïs Billard

given: Anaïs

family: Escudier

full_name: Bernard Escudier

given: Bernard

family: Gross-Goupil

full_name: Marine Gross-Goupil

given: Marine

journal_name: European Journal of Cancer

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Ipsen


title: Trans&VIH: National Survey About Trajectory and Life Conditions of HIV Trans People in France

acronym: Trans&VIH

summary: TRANS&VIH is a national survey that will explore condition of vulnerability and trajectory of transgender people living with HIV. To fulfill this purpose, clinical data from medical registry and socio-behavioral information collected through questionnaire, will help to explore this questions about vulnerability and condition of transgender people living with HIV.

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Post-Market Study of the Argus® II Retinal Prosthesis System - France

summary: This is a post-market study of the Argus II Retinal Prosthesis System. The study is being conducted in France. The objective of the study is to obtain data to further demonstrate the effectiveness and evaluate the safety of Argus II System in patients with retinitis pigmentosa who have a bare light perception or worse in both eyes.

lead_sponsor: Second Sight Medical Products

location_facility: Centre hospitalier National d'Ophtalmologie des Quinze-Vingts

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Neuroendocrine Tumors of Patients Aged of 75 y or Over in the West of France

acronym: TANGO

summary:
Neuroendocrine cancer remains a poorly known entity. Comprehensive treatment is multidisciplinary involving surgery, radiological and nuclear medicine, and medical. A national network for the management of sporadic and hereditary malignant neuro-ENdocrine Tumor (RENATEN) is in charged of coordinating this specific care. This is part of the French National Cancer INstitute (INCa) Rare Cancer Plan.

The project is in the form of an analysis of elderly population (75 years or over) with a diagnosis of neuroendocrine cancer in the western part of the France (Brittany, Pays de Loire, Normandy, Center and a part of New Aquitaine areas) representing a population of more than 12 millions of inhabitants. Oncogeriatric evaluations, specialized meetings, ...would be analysed in order to improve the care of rare cancer patients.

lead_sponsor: University Hospital, Brest


title: Causes, Analysis of the Sub-evaluating Coronary Syndromes Acute and Disparities in France in Women

acronym: CASSANDRE

summary:
Despite efforts of learned societies, community cardiology and more generally of most players in the health, cardiovascular diseases continue to be the leading cause of death among women in France and all over the Western world, there where they fell to second place among men. Clinical practice and the disparity between the sexes are still insufficiently known.

Multicenter observational study on a cross-week comparative basis with men

ReferenceType: background

ReferenceCitation: WRITING GROUP MEMBERS, Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-e215. doi: 10.1161/CIRCULATIONAHA.109.192667. Epub 2009 Dec 17. Erratum in: Circulation. 2010 Mar 30;121(12):e260. Stafford, Randall [corrected to Roger, Véronique L]. Circulation. 2011 Oct 18;124(16):e425.

ReferenceCitation: Stramba-Badiale M, Fox KM, Priori SG, Collins P, Daly C, Graham I, Jonsson B, Schenck-Gustafsson K, Tendera M. Cardiovascular diseases in women: a statement from the policy conference of the European Society of Cardiology. Eur Heart J. 2006 Apr;27(8):994-1005. Epub 2006 Mar 7.

ReferenceCitation: Bairey Merz CN, Shaw LJ, Reis SE, Bittner V, Kelsey SF, Olson M, Johnson BD, Pepine CJ, Mankad S, Sharaf BL, Rogers WJ, Pohost GM, Lerman A, Quyyumi AA, Sopko G; WISE Investigators. Insights from the NHLBI-Sponsored Women's Ischemia Syndrome Evaluation (WISE) Study: Part II: gender differences in presentation, diagnosis, and outcome with regard to gender-based pathophysiology of atherosclerosis and macrovascular and microvascular coronary disease. J Am Coll Cardiol. 2006 Feb 7;47(3 Suppl):S21-9. Review.

ReferenceCitation: Lerner DJ, Kannel WB. Patterns of coronary heart disease morbidity and mortality in the sexes: a 26-year follow-up of the Framingham population. Am Heart J. 1986 Feb;111(2):383-90.

ReferenceCitation: Michos ED, Nasir K, Braunstein JB, Rumberger JA, Budoff MJ, Post WS, Blumenthal RS. Framingham risk equation underestimates subclinical atherosclerosis risk in asymptomatic women. Atherosclerosis. 2006 Jan;184(1):201-6.

ReferenceCitation: Kwok Y, Kim C, Grady D, Segal M, Redberg R. Meta-analysis of exercise testing to detect coronary artery disease in women. Am J Cardiol. 1999 Mar 1;83(5):660-6.

ReferenceCitation: Mieres JH, Shaw LJ, Arai A, Budoff MJ, Flamm SD, Hundley WG, Marwick TH, Mosca L, Patel AR, Quinones MA, Redberg RF, Taubert KA, Taylor AJ, Thomas GS, Wenger NK; Cardiac Imaging Committee, Council on Clinical Cardiology, and the Cardiovascular Imaging and Intervention Committee, Council on Cardiovascular Radiology and Intervention, American Heart Association. Role of noninvasive testing in the clinical evaluation of women with suspected coronary artery disease: Consensus statement from the Cardiac Imaging Committee, Council on Clinical Cardiology, and the Cardiovascular Imaging and Intervention Committee, Council on Cardiovascular Radiology and Intervention, American Heart Association. Circulation. 2005 Feb 8;111(5):682-96. Epub 2005 Feb 1.

ReferenceCitation: Einstein AJ, Moser KW, Thompson RC, Cerqueira MD, Henzlova MJ. Radiation dose to patients from cardiac diagnostic imaging. Circulation. 2007 Sep 11;116(11):1290-305. Review.

ReferenceCitation: Alexander KP, Chen AY, Roe MT, Newby LK, Gibson CM, Allen-LaPointe NM, Pollack C, Gibler WB, Ohman EM, Peterson ED; CRUSADE Investigators. Excess dosing of antiplatelet and antithrombin agents in the treatment of non-ST-segment elevation acute coronary syndromes. JAMA. 2005 Dec 28;294(24):3108-16. Erratum in: JAMA. 2006 Feb 8;295(6):628.

lead_sponsor: French Cardiology Society


title: Prospective Cohort of Patients With Hepatocellular Carcinoma in France

acronym: CHIEF

summary:
Hepatocellular carcinoma (HCC) occurs in 90% of cirrhosis primary liver cancers. In France, 8,500 new cases of HCC occur each year, and about 8,000 deaths per year are related to this cancer. The 5-year survival rate is 10%, one of the lowest survival rates of all cancer types. HCC raises a number of major challenges: HCC is discovered at a curable stage in only 25% of cases, reflecting the marked delay in the diagnosis of early stages. The state of knowledge about HCC is well behind that of other cancers (no biomarker, complex carcinogenesis, influence of the aetiology, poorly valorised data, etc.). Rapid technological progress requires large-scale studies to evaluate new diagnostic and therapeutic modalities.

The CHIEF project constitutes a common basis knowledge for research project using prospectively collected data in patients with HCC, regardless of the cause and stage of the cancer.

This project is a Multicentre longitudinal observational study of patients with HCC with prospective data collection on inclusion and patient follow-up. Constitution of a biological resources collection. 5,000 patients will be included over 2 years with a follow-up of patients of 5 years.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Risk Factors Associated With the Global Burden of Disease in Reunion Island and Comparison With Mainland France and Indian Ocean Countries

summary: The question posed by this project is that of the regional estimate of the relative importance of the risk factors of the main pathologies. Our hypothesis is that these risk factors are of different relative importance in Reunion Island compared to metropolitan France.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Evaluation of the "Housing First Program" in Homeless Patients With Severe Mental Disorders in France: a Multicentric Randomized Controlled Study

summary: As mental health care shifted from state psychiatric hospitals to the community in France and western countries, the mental health system became inevitably involved in housing as it strove to meet the broader psychosocial needs of consumers. Simultaneously, as many consumers found themselves unable to find stable living in the community and struggling with addictions, they became a significant subgroup within a larger homeless population, which has received increasing policy attention over the past three decades. There are two distinct service models for adults who have severe mental illness and are homeless: the residential continuum model and the Housing First model.

design_allocation: Randomized

primary_purpose: Other

ReferenceCitation: Tinland A, Loubiere S, Cantiello M, Boucekine M, Girard V, Taylor O, Auquier P. Mortality in homeless people enrolled in the French housing first randomized controlled trial: a secondary outcome analysis of predictors and causes of death. BMC Public Health. 2021 Jul 2;21(1):1294. doi: 10.1186/s12889-021-11310-w.

family: Tinland

full_name: Aurélie Tinland

given: Aurélie

family: Loubiere

full_name: Sandrine Loubiere

given: Sandrine

family: Cantiello

full_name: Matthieu Cantiello

given: Matthieu

family: Boucekine

full_name: Mohamed Boucekine

given: Mohamed

family: Girard

full_name: Vincent Girard

given: Vincent

family: Taylor

full_name: Owen Taylor

given: Owen

family: Auquier

full_name: Pascal Auquier

given: Pascal

currency_apc_doaj: GBP

journal_name: BMC Public Health

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Loubière S, Tinland A, Taylor O, Loundou A, Girard V, Boyer L, Auquier P. Determinants of healthcare use by homeless people with schizophrenia or bipolar disorder: results from the French Housing First Study. Public Health. 2020 Aug;185:224-231. doi: 10.1016/j.puhe.2020.05.019. Epub 2020 Jul 14.

family: Loubière

full_name: S. Loubière

given: S.

full_name: A. Tinland

given: A.

full_name: O. Taylor

given: O.

family: Loundou

full_name: A. Loundou

full_name: V. Girard

given: V.

family: Boyer

full_name: L. Boyer

given: L.

full_name: P. Auquier

given: P.

journal_name: Public Health

evidence: open (author manuscript)

version: acceptedVersion

ReferenceCitation: Fond G, Boyer L, Boucekine M, Girard V, Loubière S, Lenoir C, Auquier P, Tinland A; French Housing First Study Group. Illness and drug modifiable factors associated with violent behavior in homeless people with severe mental illness: results from the French Housing First (FHF) program. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 2;90:92-96. doi: 10.1016/j.pnpbp.2018.11.006. Epub 2018 Nov 10.

journal_name: Progress in Neuro-Psychopharmacology and Biological Psychiatry

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

ReferenceCitation: Rhenter P, Tinland A, Grard J, Laval C, Mantovani J, Moreau D, Vidaud B, Greacen T, Auquier P, Girard V. Problems maintaining collaborative approaches with excluded populations in a randomised control trial: lessons learned implementing Housing First in France. Health Res Policy Syst. 2018 Apr 19;16(1):34. doi: 10.1186/s12961-018-0305-1.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

ReferenceCitation: Tinland A, Zemmour K, Auquier P, Boucekine M, Girard V, Loubière S, Fond G, Boyer L; French Housing First Study Group. Homeless women with schizophrenia reported lower adherence to their medication than men: results from the French Housing First experience. Soc Psychiatry Psychiatr Epidemiol. 2017 Sep;52(9):1113-1122. doi: 10.1007/s00127-017-1411-z. Epub 2017 Jun 27.

journal_name: Social Psychiatry and Psychiatric Epidemiology

ReferenceCitation: Tinland A, Fortanier C, Girard V, Laval C, Videau B, Rhenter P, Greacen T, Falissard B, Apostolidis T, Lançon C, Boyer L, Auquier P. Evaluation of the Housing First program in patients with severe mental disorders in France: study protocol for a randomized controlled trial. Trials. 2013 Sep 24;14:309. doi: 10.1186/1745-6215-14-309.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Cross-sectional, Multicentre, Non-interventional Study to Assess Giant Cell Arteritis Medical Practices in France

acronym: ARTEMIS

summary: The purpose of this study is to describe medical practices in patients with GCA in terms of patient journey, diagnostic methods and specific GCA treatments since diagnosis.

lead_sponsor: Chugai Pharma France


title: Spread Analysis of COVID-19 Outbreak in France by Self-assessment Web-application: an Observational Study

acronym: SourceCOVID

summary:
A coronavirus pandemic began on 12/31/2019 with a first Chinese patient. As of 04/04/2020, the epidemic affects more than 190 countries with more than 50 million official contaminations and 1,251,000 deaths. (Univ J Hopkins). This virus causes a pathology ranging from simple flu-like symptoms in 80% of cases to acute respiratory distress syndromes requiring intensive care in 5% of cases and a death rate of 1.4 to 4% of cases.

Viral contamination is airborne and fecal A first epidemic wave crossed France in March / April 2020 then a second in October / November with a source of contamination which began in mid-August 2020. The sources of propagation are not well known (what places, what times, what contacts…? ) In the context of the health crisis linked to the coronavirus, knowledge of the sources of propagation of this 2nd wave is an important issue to guide end of lockdown and second lockdown policies.

ReferenceCitation: Denis F, Septans AL, Le Goff F, Jeanneau S, Lescure FX. Analysis of COVID-19 Transmission Sources in France by Self-Assessment Before and After the Partial Lockdown: Observational Study. J Med Internet Res. 2021 May 4;23(5):e26932. doi: 10.2196/26932.

family: Denis

full_name: Fabrice Denis

given: Fabrice

family: Septans

full_name: Anne-Lise Septans

given: Anne-Lise

family: Le Goff

full_name: Florian Le Goff

given: Florian

family: Jeanneau

full_name: Stephan Jeanneau

given: Stephan

family: Lescure

full_name: François-Xavier Lescure

given: François-Xavier

currency_apc_doaj: USD

journal_name: Journal of Medical Internet Research

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications

lead_sponsor: Weprom


title: Use and Misuse of Domperidone in Parkinson's Disease in France - Observational

acronym: DUMP-obs

summary:
Parkinson disease is the second most frequent neurodegenerative disease after Alzheimer disease and affect 1% of the population over 60 years. The treatment of PD is based on dopamine replacement therapies (DRT). Nausea is the most frequent adverse event whatever the drug, occurring in 30-40% of patients at the initiation of DRT.

Domperidone, a dopamine D2 receptor antagonist with antiemetic properties, does not readily cross the blood-brain barrier, allowing its used in PD. Domperidone may prolong the duration of the QT interval in predisposed patients, and has been associated with proarrhythmia and arrhythmic deaths. Arrhythmias, sudden death and cardiac arrest were reported with high intravenous doses which has led to withdraw of the parenteral form of the drug in 1984. Two case control studies found an increased risk of sudden death associated with domperidone use. In these reports, the increased risk was depending on age, dose, and the use of domperidone in combination with CYP3A4 inhibitors. Following the discussion created by this alert, the PRAC of the EMA has issued recommendations restricting domperidone use to patients younger than 60 years at doses below 30 mg/day and for a short period (7 days).

Because there is no alternative antiemetic drug to be used in PD, domperidone is commonly prescribed as a preventive therapy in most PD patients initiating DRT. In this population, usually older than 60 years, doses of 60 or 80 mg/day are commonly prescribed, for at least 2 months of the DRT escalating dose period or longer. A particular "niche" of domperidone misuse might be patients treated with continuous subcutaneous administration of apomorphine, a second line therapy in PD, inducing severe and prolonged nausea in almost all patients. Little is known about the use of domperidone in PD in France, but misuse of domperidone in PD patients is probably very high. Data collected from two French PD cohorts, COPARK and DIGPD, showed that 8-14% of PD patients were treated with domperidone.

The aim of this proposal is to conduct a cross sectional observational study performed in consecutive patients followed by the 24 PD expert centers of the NS Park network, general hospitals and private practice neurologists, to describe the actual use of domperidone in PD patients.

status: Enrolling by invitation

ipd_sharing: Yes

ipd_sharing_description:
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Prevalence of Pathologic Gambling in the Workforce: a Cross-sectional Study in Brittany, France

acronym: PJPAP

summary:
Introduction: To date, very few studies about links between work and addictive disorders concern behavioral addictive disorders such as gambling. Such behaviours may be adaptative strategy for unsatisfied workers. The common physiopathology of addictive disorders allows us to hypothesize that it is possible that such troubles at work could promote gambling. Our aim was to evaluate the prevalence of gambling among workers and its links with work.

Patients and methods: We performed a descriptive cross-sectional monocentric study among all workers who consulted one physician between November 2016 and April 2017, from an occupational health service in Brittany, France. The first step was to ask whether they have gambled during the last year and if it was related to their occupation. The second step was a screening for risky gamblers (using the "Lie or Bet" questionnaire) among these and then to assess more precisely the severity (using the Indice Canadien du Jeu Excessif, ICJE questionnaire).


title: Use and Misuse of Domperidone in Parkinson's Disease in France - Dump Investigation

acronym: DUMP-invest

summary:
Parkinson disease is the second most frequent neurodegenerative disease after Alzheimer disease and affect 1% of the population over 60 years. The treatment of PD is based on dopamine replacement therapies (DRT). Nausea is the most frequent adverse event whatever the drug, occurring in 30-40% of patients at the initiation of DRT.

Domperidone, a dopamine D2 receptor antagonist with antiemetic properties, does not readily cross the blood-brain barrier, allowing its used in PD. Domperidone may prolong the duration of the QT interval in predisposed patients, and has been associated with proarrhythmia and arrhythmic deaths. Arrhythmias, sudden death and cardiac arrest were reported with high intravenous doses which has led to withdraw of the parenteral form of the drug in 1984. Two case control studies found an increased risk of sudden death associated with domperidone use. In these reports, the increased risk was depending on age, dose, and the use of domperidone in combination with CYP3A4 inhibitors. Following the discussion created by this alert, the PRAC of the EMA has issued recommendations restricting domperidone use to patients younger than 60 years at doses below 30 mg/day and for a short period (7 days).

Because there is no alternative antiemetic drug to be used in PD, domperidone is commonly prescribed as a preventive therapy in most PD patients initiating DRT. In this population, usually older than 60 years, doses of 60 or 80 mg/day are commonly prescribed, for at least 2 months of the DRT escalating dose period or longer. A particular "niche" of domperidone misuse might be patients treated with continuous subcutaneous administration of apomorphine, a second line therapy in PD, inducing severe and prolonged nausea in almost all patients. Little is known about the use of domperidone in PD in France, but misuse of domperidone in PD patients is probably very high. Data collected from two French PD cohorts, COPARK and DIGPD, showed that 8-14% of PD patients were treated with domperidone.

The aim of this proposal is to investigate the practices and beliefs of French neurologists regarding use and misuse of domperidone in PD, by a qualitative approach.


title: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in France

acronym: OPALE

summary: This study seeks to determine the effectiveness of the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) in participants with chronic hepatitis C (CHC) virus in clinical practices across France.

ReferenceCitation: Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.

name: Medical University of Vienna Vienna Austria

family: Ferenci

full_name: Peter Ferenci

given: Peter

name: Department of Gastroenterology and HepatologyZNA Stuivenberg Antwerp Belgium

family: Bourgeois

full_name: Stefan Bourgeois

given: Stefan

name: IFI Institut für Interdisziplinäre Medizin Hamburg Germany

family: Buggisch

full_name: Peter Buggisch

name: School of MedicineTrinity College Dublin Dublin Ireland

family: Norris

full_name: Suzanne Norris

given: Suzanne

name: Clinic of Infectious DiseasesUniversity of Medicine and Pharmacy Timişoara Timişoara Romania

family: Curescu

full_name: Manuela Curescu

given: Manuela

name: Hépato‐GastroentérologieHôpital Saint‐Eloi Montpellier France

family: Larrey

full_name: Dominique Larrey

given: Dominique

name: Department of Molecular and Clinical PharmacologyUniversity of Liverpool Liverpool UK

family: Marra

full_name: Fiona Marra

given: Fiona

name: AbbVie Deutschland GmbH & Co. KG Wiesbaden Germany

family: Kleine

full_name: Henning Kleine

given: Henning

family: Dorr

full_name: Patrick Dorr

given: Patrick

family: Charafeddine

full_name: Mariem Charafeddine

given: Mariem

family: Crown

full_name: Eric Crown

given: Eric

family: Bondin

full_name: Mark Bondin

given: Mark

family: Back

full_name: David Back

given: David

name: Department of Infectious Diseases and HepatologyMedical University of Białystok Białystok Poland

family: Flisiak

full_name: Robert Flisiak

given: Robert

journal_name: Journal of Viral Hepatitis

oa_colors: green hybrid

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: PubMed Central - Europe PMC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_normalized: HAL

title: Real‐world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1‐ and 4‐infected patients with diverse comorbidities and comedications: A pooled analysis of post‐marketing observational studies from 13 countries

location_facility: Centre Hospitalier Victor Dupo /ID# 147241

location_facility: Cabinet Medical, Dr. Verdier, /ID# 145575

location_facility: CHR Orleans - Hopital de la Source /ID# 147250

location_facility: Cabinet Medical, Boyer Darrigr /ID# 145562

location_facility: Charles Nicolle Hosp chu rouen /ID# 145557

location_facility: Ctre Hospitalier de Tourcoing /ID# 145568

location_facility: CH Des Deux Vallees Longumeau /ID# 149336

location_facility: Hopital Universitaire Purpan /ID# 145869

location_facility: CHU Strasbourg Hautepierre Hos /ID# 147246

location_facility: Centre Hospitalier Universitai /ID# 147568

location_facility: Centre Hospitalier D'Avignon /ID# 151343

location_facility: CHU de Grenoble - Albet Michal /ID# 145881

location_facility: Ctr Consultations La Sauvegard /ID# 147236

location_facility: Hopital Bichat Claude Bernard /ID# 145886

location_facility: Centre Hospitalier D'Avignon /ID# 151098

location_facility: Hopital Bichat-Claude Bernard /ID# 149246

location_facility: Centre Hospitalier de Libourne /ID# 145564

location_facility: CHU de Besancon - Jean Minjoz /ID# 145884

location_facility: Cabinet Medical, Dr. Constant, /ID# 145561

location_facility: Hopital Universitaire Purpan /ID# 150141


title: Screening for Postpartum Depression and Associated Risk Factors Among Women Who Deliver in Four Hospital in France During the COVID-19 Epidemic

summary: Postpartum depression (PPD) represent around 15% of birth in developed countries. The context of the COVID-19 epidemy represents a possible source of additional emotional distress. The objective of this study is to determine the screening prevalence and risk factors of postpartum depression, among women who deliver in fourth hospital in the North of France in the context of the COVID epidemy.


title: The ESPERES Prospective Cohort of Healthcare Workers in France: Study on COVID-19 Vaccine and the COVID-19 Pandemic

summary:
This is the first study performed within the ESPERES cohort, related to prevention against COVID-19, in particular vaccination against COVID-19 and more broadly on the COVID-19 pandemic.

ESPERES is a national prospective e-cohort study providing a resource for collecting information on healthcare workers (HCWs) currently working in France. The overall goal of ESPERES is to develop the infrastructure necessary to create and engage a community of HCWs who may be eligible for participation in future research studies. ESPERES is set up to answer research questions, in the field of prevention for HCWs, prevention for their own health, that of their relatives, their colleagues, and users of the hospital. These research questions will be carried out in the context of specific subsequent studies.


title: Retrospective Study to Describe Carfilzomib Use on Patients With Relapsed Multiple Myeloma in France in the Context of Carfilzomib Nominative Expanded Access and Compassionate Use

acronym: CARMYN

summary: This retrospective multicenter observational study will provide real-life efficacy and tolerance data for patients with relapsed multiple myeloma (RMM) treated with carfilzomib in the context of nominative expanded access and compassionate use in France, and will allow to evaluate healthcare practices from data obtained during the use of carfilzomib for routine care. Nominative expanded access was open in February 2014 and stopped in march 2016, then relayed by the compassionate program (march 2016- February 2017).

lead_sponsor: Centre Hospitalier le Mans


title: Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France

acronym: FAST

summary: Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir with new HIV patients in France

primary_purpose: Treatment

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

location_facility: Hôpital Côte de Nacre - Service des Maladies Infectieuses

location_facility: Hôpital Henri Mondor - Service d'Immunologie Clinique

location_facility: Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales

location_facility: Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses

intervention_type: Drug


title: Apixaban in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France - Cross-sectional Study

summary:
The present study will be conducted to assess the following research questions in real-life conditions in France:

What are the patient and disease characteristics, comorbidities and treatment history in NVAF patients initiating a new Anticoagulant (AC) treatment, according to treatment currently available and prescribed (apixaban, other NOACs, VKAs), and are the AC-naive patient profiles different from one treatment pattern to another when initiating a new AC treatment?

What are the HCP's reasons for discontinuing the previous AC strategy for initiating and choosing the newly initiated AC treatment in NVAF patients?

What are the conditions of newly-initiated apixaban prescriptions in NVAF patients: prescriber, proportion of naïve/experienced patients, daily dosage and number of daily doses?

lead_sponsor: Bristol-Myers Squibb


title: Clinical Characteristics of Patients Referred to a Substance Abuse Liaison Department in an Academic Hospital, France

acronym: AddictUrge

summary: The Coalition on Psychiatric Emergencies (CPE) stressed in 2016 that emergency providers were increasingly recognizing the important role of the Emergency Department (ED) in reducing adverse outcomes associated with untreated with substance abuse liaison department (SUDs). Additional research is required to close identified knowledge gaps and improve care of ED patients with SUD. Of the more than 4.5 million ED visits in 2009 in US for drug-related causes,34-32% involved alcohol use alone or in combination with other drugs. Few studies investigated the clinical characteristics of patients referred to an addiction liaison department in a general hospital. The present study will be retrospective in a sample of 700 patients consecutively admitted for addictive behaviors in the emergency department and in the Medicine or Surgery departments of the Amiens University Hospital Center, France.


title: Parental Compliance After Telephone Triage Advice During and After Confinement During the COVID-19 Epidemic in France

acronym: COVIDTEL

summary:
Novel Coronavirus disease 2019 (COVID-19) outbreak seriously challenges worldwide health care systems. The current climate of anxiety due to COVID-19 and home confinement limiting access to emergency departments (ED) have induced an increase of phone calls to the emergency call center "15" medical advices.

To determine if a pediatric telephone triage protocol may improve patient's pathways during COVID-19 outbreak, parental compliance is assessed after telephone advice, during and after home confinement (the end of home confinement in France was on May 11th 2020).

From 14th April 2020 to 7th June 2020, all calls received by the platform of telephone calls at Children's Lenval Hospital during open hours and open days are collected. For each call, symptoms are recorded by trained physicians and trained residents using a telephonic triage tool through a directed interview. A medical orientation is recommended to parents at the end of their call. Follow-up are conducted 2 to 4 days after with their consent by telephone interview in order to evaluate their compliance

status: Withdrawn

lead_sponsor: Fondation Lenval


title: Multicenter Retrospective Study From 5 Hemostasis Treatment Centers in Western France: Severe Hemorrhagic Treated Occurrences' Patterns and Global Substitutive COagulation Factors THerapy in the Inherited Von WILLebrand Disease

summary:
Von Willebrand disease (VWD) is the most common constitutional bleeding disorder in the world, caused by missing or defective von Willebrand factor (VWF). In France, VWD affects approximatively 7,000 patients.

There are many types of VWD. The severest forms are characterized by the occurrence of extremely serious bleedings, requiring in-stays with clotting factors (CF) treatments in specialized hospital units and/or an ambulatory substitutive therapy; both of them are highly expensive.

In France, Hemostasis Treatment Centers (HTC) have the opportunity to record these kinds of data in a database called NHEMO (Net-Hemostasis = care database for constitutional bleeding disorders). Further ahead, the data can be coded, dumped into and extracted from the research database BERHLINGO and analyzed.

The HOPSCOTcH-WILL study will be a retrospective, non-interventional, multicenter (national) cohort study & will provide an overview of the real-life management of patients with VWD in western France requiring a substitutive treatment with VWF, as well as a description of the characteristics of their hemorrhagic events.

Model : Observationnal, real world evidence study. Time Horizon : 2015-2018. HTC (France): Western University Hospitals (BERHLINGO network) = Nantes University Hospital (promotion), Angers University Hospital, Brest University Hospital, Le Mans Regional Hospital & Rennes University Hospital

lead_sponsor: Nantes University Hospital

location_facility:
Brest University Hospital
Rennes University Hospital
Le Mans Regional Hospital
Angers University Hospital
Nantes University Hospital


title: Association Between Long-term Hydroxychloroquine Treatment and Outcome of a History of Symptoms Suggestive of COVID-19 Infection During the Epidemic Period in France in Patients With Autoimmune Disease

acronym: COVCALL

summary: This epidemiological, transversal, cohort study aims to determine the potential influence of an active long-term hydroxychloroquine intake over the prevalence of a history of symptoms evocative of a COVID-19 infection in patients with a history of systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome or psoriatic arthritis, during the epidemic period in France. The information is gathered using a standardized questionnaire, by phone call.

ReferenceCitation: Guillaume D, Magalie B, Sina E, Imène SM, Frédéric V, Mathieu D, Aurore M, Yoni G, Emma E, Charlotte B, Laura F, Alain S, Steven N, Pierre Z, Jean-Luc F, Romain C, Alice GD, Adrien M, Wassim G, Pierre-Emmanuel R, Christophe P, Catherine C, Kevin B, Thomas S, Damien G. Antirheumatic Drug Intake Influence on Occurrence of COVID-19 Infection in Ambulatory Patients with Immune-Mediated Inflammatory Diseases: A Cohort Study. Rheumatol Ther. 2021 Dec;8(4):1887-1895. doi: 10.1007/s40744-021-00373-1. Epub 2021 Sep 16.

family: Guillaume

full_name: Debellemanière Guillaume

given: Debellemanière

family: Magalie

full_name: Bouvet Magalie

given: Bouvet

family: Sina

full_name: Elahi Sina

given: Elahi

family: Imène

full_name: Salah-Mabed Imène

given: Salah-Mabed

family: Frédéric

full_name: Vayr Frédéric

given: Vayr

family: Mathieu

full_name: Dubois Mathieu

given: Dubois

family: Aurore

full_name: Muselier Aurore

given: Muselier

family: Yoni

full_name: Gozlan Yoni

given: Gozlan

family: Emma

full_name: Elbaz Emma

given: Elbaz

family: Charlotte

full_name: Badatcheff Charlotte

given: Badatcheff

family: Laura

full_name: Fabre Laura

given: Fabre

family: Alain

full_name: Saad Alain

given: Saad

family: Steven

full_name: Nahaisi Steven

given: Nahaisi

family: Pierre

full_name: Zeboulon Pierre

given: Zeboulon

family: Jean-Luc

full_name: Febbraro Jean-Luc

given: Febbraro

family: Romain

full_name: Courtin Romain

given: Courtin

family: Alice

full_name: Grise-Dulac Alice

given: Grise-Dulac

family: Adrien

full_name: Mazharian Adrien

given: Mazharian

family: Wassim

full_name: Ghazal Wassim

given: Ghazal

family: Pierre-Emmanuel

full_name: Remongin Pierre-Emmanuel

given: Remongin

family: Christophe

full_name: Panthier Christophe

given: Panthier

family: Catherine

full_name: Chirouze Catherine

given: Chirouze

family: Kevin

full_name: Bertrand Kevin

given: Bertrand

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Medical Treatment of Solid Tumors at the Lyon University Hospital Cancer Institute During the First Wave of COVID-19 in France: A Conservative Approach

acronym: COCA

summary:
An article to present how cancer patients were taken in charge at Lyon University Hospital Cancer Institute (France) during the first peak of the COVID-19 pandemic between March and May 2020 is under writing.

It will present strategies that were set-up to avoid cross-contamination between patients and caregivers, patients treatment adaptation (timing, dosage,..) and how consultations, multidisciplinary team meetings, surgical procedures and clinical trials were impacted.

Part of this article will also illustrate the characteristics of patients with a solid tumor(s) that have been hospitalized during this timeframe for the COVID-19. How cancer type and stage affect Covid severity and mortality.will be described for a small sample of patients (44). These qualitative figures will be compared to literature current state of the art.

lead_sponsor: Hospices Civils de Lyon


title: Current Incidence and Treatments Performed of Fractures of the Acetabulum and Pelvis in France in 2013

acronym: ACETABULUM

summary: Fractures of the acetabulum and pelvis are serious injuries to vital prognostic can play in cases of severe bleeding. In all cases the functional is a major issue with a potential reach of walking ability and maintaining the seated and standing positions. The treatment of such lesions requires management to a specialist, or the ability to use such centers for advice or transferring patients. This organization was recommended after the symposium of the French Society of Orthopedic Surgery (SOFCOT) in 2009. With the aging population, the incidence and clinical features of these fractures have evolved to worsening the functional prognosis. Club Basin acetabulum, body SOFCOT, wants to achieve an observational study assessing needs and practices at national and regional level. The long-term objective is to propose a regional organization of care of these patients in order to reduce morbidity and mortality associated.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Feasibility Study on Estimating the Prevalence and Management of Stage 4 Chronic Kidney Disease in Adults Via Laboratories and Nephrologists in the Gard, France

acronym: MRC-Gard

summary: The main objective of this study is to evaluate the feasibility of estimating the prevalence of stage 4 and 5 chronic kidney disease in the Gard department of France from data obtained via laboratory databases. To verifiy if the demand for care thus authenticated by laboratory tests is adapted to nephrology care delivery, as recommended by the French High Authority of Health (HAS), laboratory data will be compared with those of patients seen by nephrologists in the department.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: AIDER - Unité de Dialyse de Nîmes, CHU Carémeau


title: CIRSE Registry for SIR-Spheres in France (CIRT-FR)

acronym: CIRT-FR

summary: Selective Internal Radiation Therapy (SIRT), also known as radioembolisation, is a minimal invasive, endovascular treatment for primary and secondary liver tumours. In France, SIR-Spheres are listed as reimbursable by the national health authorities (Haute Autorité de Santé [HAS]). In order to evaluate the reimbursement after five years, all patients treated with SIR-Spheres will be entered into a registry that collects data on the real-life clinical application of SIRT and reports to the national authorities.

ReferenceCitation: Loffroy R, Ronot M, Greget M, Bouvier A, Mastier C, Sengel C, Tselikas L, Arnold D, Maleux G, Pelage JP, Pellerin O, Peynircioglu B, Sangro B, Schaefer N, Urdániz M, Kaufmann N, Bilbao JI, Helmberger T, Vilgrain V; CIRT-FR Principal Investigators. Short-term Safety and Quality of Life Outcomes Following Radioembolization in Primary and Secondary Liver Tumours: a Multi-centre Analysis of 200 Patients in France. Cardiovasc Intervent Radiol. 2021 Jan;44(1):36-49. doi: 10.1007/s00270-020-02643-x. Epub 2020 Sep 25.

family: Loffroy

full_name: Romaric Loffroy

given: Romaric

family: Ronot

full_name: Maxime Ronot

given: Maxime

family: Greget

full_name: Michel Greget

given: Michel

family: Bouvier

full_name: Antoine Bouvier

given: Antoine

family: Mastier

full_name: Charles Mastier

given: Charles

family: Sengel

full_name: Christian Sengel

given: Christian

family: Tselikas

full_name: Lambros Tselikas

given: Lambros

family: Arnold

full_name: Dirk Arnold

given: Dirk

family: Maleux

full_name: Geert Maleux

given: Geert

family: Pelage

full_name: Jean-Pierre Pelage

given: Jean-Pierre

family: Pellerin

full_name: Olivier Pellerin

given: Olivier

family: Peynircioglu

full_name: Bora Peynircioglu

given: Bora

family: Sangro

full_name: Bruno Sangro

given: Bruno

family: Schaefer

full_name: Niklaus Schaefer

given: Niklaus

family: Urdániz

full_name: María Urdániz

given: María

family: Kaufmann

full_name: Nathalie Kaufmann

given: Nathalie

family: Bilbao

full_name: José Ignacio Bilbao

given: José Ignacio

family: Helmberger

full_name: Thomas Helmberger

given: Thomas

family: Vilgrain

full_name: Valérie Vilgrain

given: Valérie

family: Piana

full_name: Gilles Piana

given: Gilles

family: Frandon

full_name: Julien Frandon

given: Julien

family: Tasu

full_name: Jean-Pierre Tasu

family: Kobeiter

full_name: Hicham Kobeiter

given: Hicham

name: On behalf of the CIRT-FR Principal Investigators

journal_name: CardioVascular and Interventional Radiology

lead_sponsor: Cardiovascular and Interventional Radiological Society of Europe

location_facility:
Hôpital Henri Mondor
Centre Léon Bérard
CHU d'Angers
CHU de Bordeaux
Institut Paoli-Calmettes
Chu de Dijon
CHU de Poitiers
CHU de Nimes
CHRU de Strasbourg
CHU de Grenoble Alpes
CHU de Lyon
Institut Gustave Roussy
Hôpital Beaujon


title: The Offer of Neurosurgery Care in the Grand Est of France During the Health Crisis Linked to Covid-19

acronym: NeurochirCOVID

summary:
During this exceptional health crisis, this study of the current care of a neurosurgical activity, which is essential in a University Hospital Centre, will enable us to better understand how we function, the response given to a population with the means at our disposal, the implementation of new therapeutic strategies and their limits, ethical reflection, and, how to pursue a distributive and quality medicine.

The restriction of conventional medical resources to our care activity (resuscitation, personnel, operating theatre, constraints linked to the risk of contamination...) is leading to a new medical organisation imposing new Covid-19 standards, the description of which seems essential to us.

A knowledge of the strategies to be adopted during a disaster health situation in order to continue providing care to the civilian population. How can we prevent the setting up of health care systems outside the cause of the health crisis? n triage medicine, Avoiding the "burn-out" of doctors struck by the health crisis.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Department of Neurosurgery - Strasbourg University Hospitals


title: Study of the Seroprevalence of SARS-CoV-2 in Hospital Staff in Strasbourg University Hospital, Strasbourg, France

acronym: SeroCoV-HUS

summary:
COVID-19 is a new emerging disease caused by infection with the SARS-CoV-2 coronavirus, with no specific therapeutic options.

Since the end of February 2020, the Strasbourg University Hospital (HUS) had faced a sudden increase of patients with COVID-19 resulted from a SARS-CoV-2 superspreading event (religious meeting). Infected individuals went to regional hospitals, and this led to a cluster of infected healthcare workers at the Strasbourg University Hospitals from the first week of March. To date, several hundred Strasbourg hospital workers have presented a SARS-CoV-2 infection confirmed by the RT-PCR test from a nasopharyngeal sample. Most of them developed a mild form of COVID-19.

It is important to understand how far the infection has spread in the hospital staff, and to which extent the individuals who have been infected develop antibodies against SARS-CoV-2.

design_allocation: Non-Randomized

location_facility: Hôpitaux Universitaires de Strasbourg - Centre d'Investigation Clinique - Nouvel Hôpital Civil et Hautepierre

intervention_type: Diagnostic Test


title: How Point-of-care Ultrasound Affects the Diagnostic and Therapeutic Process in General Practice. A Prospective Follow-up Study in France

acronym: Echo-MG

summary:
This study explores how Point of Care Ultrasound (POC-US) is used in general practice in France and how it affects the diagnostic process and treatment of patients.

General practitioners (GPs) will register information each time they use POC-US during a one month period.

The aim of this study is to describe the use of POCUS and its role in the diagnostic and therapeutic process in general medicine.

Description of the use of POCUS through indication, organs scanned, findings, frequency , time consumption.
Analysis of the role of POCUS in the diagnostic process: change of diagnostic hypotheses and change of certainty in the main diagnostic hypothesis.
Analysis of the role of POCUS in the therapeutic process: change in the care pathway and the therapeutic initial plan.

This is an observational study without any intervention.

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ReferenceCitation: Wagner M, Shen-Wagner J, Zhang KX, Flynn T, Bergman K. Point-of-Care Ultrasound Applications in the Outpatient Clinic. South Med J. 2018 Jul;111(7):404-410. doi: 10.14423/SMJ.0000000000000835. Review.

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ReferenceCitation: Mayordomo-Colunga J, González-Cortés R, Bravo MC, Martínez-Mas R, Vázquez-Martínez JL, Renter-Valdovinos L, Conlon TW, Nishisaki A, Cabañas F, Bilbao-Sustacha JÁ, Oulego-Erroz I. [Point-of-care ultrasound: Is it time to include it in the paediatric specialist training program?]. An Pediatr (Engl Ed). 2019 Sep;91(3):206.e1-206.e13. doi: 10.1016/j.anpedi.2019.06.012. Epub 2019 Aug 6. Spanish.

ReferenceCitation: Torres-Macho J, Aro T, Bruckner I, Cogliati C, Gilja OH, Gurghean A, Karlafti E, Krsek M, Monhart Z, Müller-Marbach A, Neves J, Sabio R, Serra C, Smallwood N, Tana C, Uyaroğlu OA, Von Wowern F, Bosch FH; EFIM´s ultrasound working group. Point-of-care ultrasound in internal medicine: A position paper by the ultrasound working group of the European federation of internal medicine. Eur J Intern Med. 2020 Mar;73:67-71. doi: 10.1016/j.ejim.2019.11.016. Epub 2019 Dec 11.

ReferenceCitation: Bhagra A, Tierney DM, Sekiguchi H, Soni NJ. Point-of-Care Ultrasonography for Primary Care Physicians and General Internists. Mayo Clin Proc. 2016 Dec;91(12):1811-1827. doi: 10.1016/j.mayocp.2016.08.023. Epub 2016 Nov 5. Review.

ReferenceCitation: Liu RB, Donroe JH, McNamara RL, Forman HP, Moore CL. The Practice and Implications of Finding Fluid During Point-of-Care Ultrasonography: A Review. JAMA Intern Med. 2017 Dec 1;177(12):1818-1825. doi: 10.1001/jamainternmed.2017.5048. Review.

ReferenceCitation: Vinayak S, Sande J, Nisenbaum H, Nolsøe CP. Training Midwives to Perform Basic Obstetric Point-of-Care Ultrasound in Rural Areas Using a Tablet Platform and Mobile Phone Transmission Technology-A WFUMB COE Project. Ultrasound Med Biol. 2017 Oct;43(10):2125-2132. doi: 10.1016/j.ultrasmedbio.2017.05.024. Epub 2017 Jul 14.

ReferenceCitation: Ma IWY, Arishenkoff S, Wiseman J, Desy J, Ailon J, Martin L, Otremba M, Halman S, Willemot P, Blouw M; Canadian Internal Medicine Ultrasound (CIMUS) Group*. Internal Medicine Point-of-Care Ultrasound Curriculum: Consensus Recommendations from the Canadian Internal Medicine Ultrasound (CIMUS) Group. J Gen Intern Med. 2017 Sep;32(9):1052-1057. doi: 10.1007/s11606-017-4071-5. Epub 2017 May 11.

ReferenceCitation: Kimura BJ. Point-of-care cardiac ultrasound techniques in the physical examination: better at the bedside. Heart. 2017 Jul;103(13):987-994. doi: 10.1136/heartjnl-2016-309915. Epub 2017 Mar 4. Review.

ReferenceCitation: Arora S, Cheung AC, Tarique U, Agarwal A, Firdouse M, Ailon J. First-year medical students use of ultrasound or physical examination to diagnose hepatomegaly and ascites: a randomized controlled trial. J Ultrasound. 2017 Aug 19;20(3):199-204. doi: 10.1007/s40477-017-0261-6. eCollection 2017 Sep.

ReferenceCitation: Buonsenso D, Pata D, Chiaretti A. COVID-19 outbreak: less stethoscope, more ultrasound. Lancet Respir Med. 2020 May;8(5):e27. doi: 10.1016/S2213-2600(20)30120-X. Epub 2020 Mar 20.

ReferenceCitation: Hocine S. Part de l'échoscopie dans la pratique de l'échographie par les médecins généralistes français. Faculté de sciences médicales et paramédicales de Marseille; 2019.

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ReferenceCitation: Sorensen B, Hunskaar S. Point-of-care ultrasound in primary care: a systematic review of generalist performed point-of-care ultrasound in unselected populations. Ultrasound J. 2019 Nov 19;11(1):31. doi: 10.1186/s13089-019-0145-4. Review.

ReferenceCitation: Andersen CA, Davidsen AS, Brodersen J, Graumann O, Jensen MB. Danish general practitioners have found their own way of using point-of-care ultrasonography in primary care: a qualitative study. BMC Fam Pract. 2019 Jun 28;20(1):89. doi: 10.1186/s12875-019-0984-x.

ReferenceCitation: Løkkegaard T, Todsen T, Nayahangan LJ, Andersen CA, Jensen MB, Konge L. Point-of-care ultrasound for general practitioners: a systematic needs assessment. Scand J Prim Health Care. 2020 Mar;38(1):3-11. doi: 10.1080/02813432.2020.1711572. Epub 2020 Jan 20.

ReferenceCitation: Rempell JS, Saldana F, DiSalvo D, Kumar N, Stone MB, Chan W, Luz J, Noble VE, Liteplo A, Kimberly H, Kohler MJ. Pilot Point-of-Care Ultrasound Curriculum at Harvard Medical School: Early Experience. West J Emerg Med. 2016 Nov;17(6):734-740. Epub 2016 Sep 12.

ReferenceCitation: American Academy of Family Physicians. Recommended Curriculum Guidelines for Family Medicine Residents. Point of Care Ultrasound [Internet]. [cité 28 avr 2020]. Disponible sur: https://www.aafp.org/dam/AAFP/documents/medical_education_residency/program_directors/Reprint290D_POCUS.pdf

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ReferenceCitation: Van Gansbeke V. [Sonography : a future imaging modality for the general practitioner ?]. Rev Med Brux. 2018;37(4):205-213. French.

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ReferenceCitation: Myklestul HC, Skonnord T, Brekke M. Point-of-care ultrasound (POCUS) in Norwegian general practice. Scand J Prim Health Care. 2020 Jun;38(2):219-225. doi: 10.1080/02813432.2020.1753385. Epub 2020 Apr 21.

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ReferenceCitation: Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104.

ReferenceCitation: Lemanissier M. L'échographe, deuxième stéthoscope du médecin généraliste ? Validation d'une première liste d'indications d'échographies réalisables par le médecin généraliste. [Thèse d'exercice]. Université Paul Sabatier Toulouse III; 2013.

ReferenceCitation: Aakjær Andersen C, Brodersen J, Davidsen AS, Graumann O, Jensen MBB. Use and impact of point-of-care ultrasonography in general practice: a prospective observational study. BMJ Open. 2020 Sep 17;10(9):e037664. doi: 10.1136/bmjopen-2020-037664.

ipd_sharing_description: The data registered are available for the cooperating researchers at the university in Aalborg Denmark. The purpose of further analyses is to compare the external validity of the questionnaire.

lead_sponsor: Sorbonne University

location_facility: Departement de Medecine Generale Sorbonne


title: A Multi-Center, Longitudinal, Prospective, Observational, Multi-Cohort Study of Patients With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment (LIST, Lung Initiative on Sequence Therapy)

acronym: LIST

summary:
The purpose of this trial is to describe the following, for each cohort, in real world conditions in France:

The characteristics and treatment sequence of patients treated with nivolumab
The effectiveness of nivolumab treatment
The safety profile of nivolumab
Treatment patterns (e.g. duration of treatment, subsequent treatments) of nivolumab
The patient-reported outcomes (PRO) in patients treated with nivolumab, at baseline and during follow up using the EuroQoL-5D-3L


title: Real-life Data of Constitutional Von Willebrand Disease in Western France: Treatment Outcomes With the Recombinant Von Willebrand Factor

acronym: HOPSCOTCH-II

summary:
The objective of this observational study HOPSCOTcH-WILL II is to provide an accurate and detailed account of current Von Willebrand Disease (VWD) therapeutic management by collecting real-life data on hemorrhagic treated events in the 5 Western French Hemophilia Treatment Center.

The HOPSCOTCH-WILL II study aims to describe therapeutic management of patients with VWD, following the provision of a recombinant drug in France; It will also permit to carry out a budget impact analysis to quantify the economic significance of this new era.

location_facility:
CHU Angers
CH Le Mans
CHU de Nantes
CHR de Brest
CHU Rennes


title: An Exploratory Study to Evaluate the Acceptability of PKU Explore, a Food for Special Medical Purposes, for Use in the Dietary Management of Phenylketonuria in Infants From 6 Months to 3 Years of Age With Regard to Product-acceptability, Tolerance, Phe Levels and Growth

summary: PKU explore France is an exploratory study to evaluate the acceptability of PKU explore, a food for special medical purposes, for use in the dietary management of phenylketonuria in infants from 6 months to 3 years of age, assessing participant adherence, GI tolerance, phe levels, growth and product palatability.

primary_purpose: Supportive Care

lead_sponsor: Vitaflo International, Ltd

intervention_type: Dietary Supplement


title: Proposal of a Method Using the PMSI and SNIIRAM National Databases to Estimate the Frequency of Physical Abuse and to Identify th Eassociated At-risk Situations and Consequences in Children Aged 0 to 5 Years in France

acronym: MENFIS

summary: The epidemiological data currently available on child abuse in France are very inadequate. They do not make it possible to know the number of child victims, nor the precise context and impact of this violence. Very often, the figures put forward are underestimated. Improving the knowledge of these situations would make it possible to develop targeted primary and secondary prevention programs. In this study, is proposed an innovative method of exploiting existing national databases, the PMSI and SNIIRAM, with the aim of 1) approaching an order of magnitude of the frequency of physical abuse in children and 2) evaluating its contexts and consequences. The PMSI is a high-quality database that has been used for many years for medical research purposes. It provides a large amount of epidemiological information and can be used to create cohorts large enough to detect rare events. The SNIIRAM/EGB data allows the recovery of all data on reimbursed consumption, such as drug treatments, biological examinations carried out or consultations (with general practitioners or specialists).

lead_sponsor: Centre Hospitalier Universitaire Dijon


type: Registry Identifier

title: Syndrome Fibromyalgique en France : Place de l'évaluation et de la Prise en Charge Des Troubles du Sommeil

acronym: FIBOBS

summary: The FIBOBS study is a multi-center, interventional, prospective study carried out within specialized chronic pain structures (CPS) in metropolitan France. It will estimate the prevalence of sleep disorders, divided into three categories (poor quality of sleep in general, sleep apnea syndrome, restless legs syndrome), using self-questionnaires in patients with Fibromyalgia Syndrome consulting within a CPS. The interaction between these sleep disorders and other symptoms of Fibromyalgia Syndrome will also be analyzed using self-administered questionnaires. Based on the hypothesis that sleep disorders associated with Fibromyalgia syndrome are only imperfectly assessed and/or treated in CPS, the FIBOBS study will also interview algologists in order to know both the diagnostic tools used and the recommended management when sleep disorders are suspected in the context of Fibromyalgia syndrome. In addition, this study will provide a better understanding of the symptoms of Fibromyalgia syndrome, their impact and how patients feel.

lead_sponsor: Centre Hospitalier Emile Roux

location_facility: Hôpital Nord Ouest - Site Villefranche-sur-Saône

location_facility: Clinique Mutualiste de la Porte de Lorient

location_facility: Hôpital Pierre Paul Riquet - CHU Toulouse

location_facility: CHU Dupuytren 2 - Centre de la douleur chronique


title: The MiniMed™ 780G Glycemic Control and Quality of Life Study for the Treatment of Pediatric and Adult Subjects With Type 1 Diabetes in France (EQOL Study)

summary: The purpose of the study is to evaluate the efficacy in glycemic control and the impact on the quality of life of patients using the MiniMed™ 780G System for the treatment of Type 1 diabetes, in real life settings in France.

lead_sponsor: Medtronic Diabetes

location_facility: APHM Marseille (Hôpital de la Conception)


title: INTHEMO: Occupational Integration of Adults With Severe Haemophilia in France: a Study Based on the FranceCoag Cohort

acronym: INTHEMO

summary: Severe haemophilia and subsequent arthropathy result in joint pain, disability and impaired health-related quality of life. Improvements in haemophilia care over the last decades might lead to expectation of a near-normal quality of life for adults with haemophilia. However, little is known about the impact of haemophilia and its treatment on social functioning. A study based on a national US cohort of 141 young men (18-34 y.o.) showed that, compared to the general US population, this cohort experienced social burdens such as unemployment and lower high-school graduation rates. Another study conducted in the framework of the HERO (Haemophilia Experiences, Results and Opportunities) international initiative showed that a majority of the 230 young adults aged 18-30 years (including 16 French participants) were employed at least part-time (62%) and most of them reported that haemophilia has had a negative impact on employment (76%) which was reported as moderate or very large by 47% of the participants. The replicability of these results could be limited by the specific socio-economic national context. In France, a survey was conducted in 2008 to assess quality of life and its determinants in children, adolescents and adults with moderate and severe haemophilia. Descriptive results on the socio-economic characteristics of the included adults showed that 51.3% of them had access to higher education (which was higher than the observed rate in the French general population in 2005, i.e. 32.5%), and that 52.1% were employed among whom 44.3% had an at-risk activity. In spite of these results which were presented in a descriptive report by the InVS (Institut de veille sanitaire - French Institute for Public Health Surveillance), some limitations could be discussed:

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital de la Timone Assistance Publique Hôpitaux de Marseille


title: Impact Evaluation at 3 Months Follow-up of a Brief Motivational Intervention in Reducing Alcohol Consumption Versus Simple Written Advice Only Among Adolescents Aged 16-24 in Pontchaillou Hospital Emergency Department in Rennes, France

acronym: AURAIA

summary:
The purpose of this study is to evaluate the effectiveness of a Brief Motivational Intervention (BMI), in reducing alcohol consumption among patients with hazardous or harmful drinking admitted in emergency department (ED). Patients aged 16 to 24 and who tested positive for blood alcohol content (BAC) of 0.5g/l. or above are enrolled.

Patients receive either an information leaflet or an information leaflet plus a referral to a psychologist. BMI is provided by the psychologist. BMI consists in a first face-to-face interview (35-45 minutes) plus a telephone interview, at 1 and 2 months. Minors' parents are also invited to attend the BMI session. If necessary, patients can be referred to relevant care and treatment services for alcohol misuse.

In a simple blind, randomised controlled clinical trial of 280 patients, 140 patients are allocated to the treatment group and 140 to the control group. Randomisation is stratified according to patient's age (16-17 or 18-24). Opaque and sealed randomized envelops are used for randomisation.

Alcohol consumption is measured by self-report at 3 months. The principal criteria used to assess the reduction of alcohol use at 3 months follow-up is the number of alcoholic drinks in the last week. Other events such as ED readmission, quarrels related to alcohol, drinking and driving, sexual intercourse without protection will also be assessed. It is the first clinical trial in France comparing these two interventions among young patients in ED with this design.

primary_purpose: Prevention

lead_sponsor: Rennes University Hospital

intervention_type: Behavioral


title: Baclocur® Post-Authorisation Safety Study in Real-life Settings in France

acronym: BACLOLIFE

summary: The overall goal of the study is to further characterize the risks and the safety profile of Baclocur® in real life settings, over a 12-month follow-up period.

lead_sponsor: Ethypharm


title: Severity of Periodontal Recession by Patient and Associated Risk Factors in France.

acronym: Recession

summary: The severity of periodontal recessions for each examined patient during dental consultation was evaluated. Moreover, the description of the number of periodontal recessions in patients with good health during dental consultation, the associated risk factors and evaluation of the number of recessions which need surgical therapy were realized.

lead_sponsor: Central Hospital, Nancy, France

location_facility:
CHU Ragueil
CHU Saint Roch
CHU
CHU Henri Mondor


title: Evaluation of a XIENCE V® Endoprothesis Used for Coronary Angioplasty, for LPPR (List of Reimbursable Products and Services) Indications in Patients Monitored for 2 Years in France

acronym: Far XIENCE V®

summary: The objective of this study is to prepare elements of response to the Haute Autorité de Santé (High Health Authority) of France, which is expecting data relating to the routine use of XIENCE V® endoprothesis within the 5 years following its marketing.

lead_sponsor: Abbott Medical Devices

location_facility:
Association Clinique Bizet
CH Prive Saint-Martin
Clinique Generale De Marignane
Polyclinique Du Bois
CH General Marechal Joffre
Clinique Saint-Pierre
CH Jean Minjoz
Polyclinique de Poitiers
Polyclinique St. Laurent
Hopital Pontchaillou
CH DE Lagny- Marne La Valee
Clinique Du Tonkin
Polyclinique Du Bois Bernard
CH Saint Louis
Clinique Les Fontaines
Hopital Foch
Institut Hospitalier Jacques Cartier
Clinique Saint Gatien
CH Universitaire
CMC De Parly II
CH Prive Beauregard
Hopital Charles Nicolle-CHU
Centre Cardilogique du Nord
Clinique Pasteur
Clinique De L'Europe
Hopital Prive Les Franciscaines
Hôpital de la Cavale Blanche-CHU
Clinique LaFourcade
Hopital Emile Muller
Clinique De L'Orangerie
Hôpital Européen Georges Pompidou
C.M.C.O De La Cote D'Opale
Clinque Pasteur
Polyclinique De Vauban
Clinique Des Cedres
Institut Mutualiste Montsouris
Hopital Albert Schweitzer
Clinique Du Millenaire
Centre Cardiologique D'Evecquemont
Centre Cardio-Vasculaire Valmante
Hopital de Brabois_CHU Nancy
CH ST Joseph St. Luc
Clinique La Casamance - UCV
Clinique Ambroise Pare
Clinicque St. Martin
Hopital Claude Gallien - ICPS
Clinique De L'Ormeau-CCV Des Pyrenees
Hopital De Rangueil - CHU
CH Jacques Coeur
Hopital Prive D'Antony
NCN-Nouvelles Cliniques Nantaises
Centre Hospitalier De Valenciennes
Polyclinique Louis Pasteur
Clnique Rhone-Durance
Polyclinique les Fleurs
Clinique La Casamance-Vista
CH Bretagne Atlantique


title: Sero-epidemiological Study of the SARS-CoV-2 Virus in France: Constitution of a Collection of Human Biological Samples

acronym: CORSER

summary:
On January 2020, the discovery of a new coronavirus (SARS-CoV-2) was officially announced by the Chinese health authorities and the World Health Organization (WHO). Its complete genome was sequenced by the laboratory of respiratory infection viruses at the Institut Pasteur on 29 January 2020 in France. This will allow the identification of antigenic structures involved in the immune response and the development of serological diagnostic tests.

Many questions are being asked about this new virus and the infection it causes, including questions about the percentage of asymptomatic and pauci-symptomatic forms. Serological studies can provide answers to these questions. There is no serological test for SARS-COV-2 yet, but the laboratory of respiratory infection viruses at the Institut Pasteur is working on its development.

This study proposes to carry out a collection of samples taken from subjects who travelled to China before the epidemic outbreak or suspected of being infected with SARS-CoV-2.

As soon as it is available, serology will be performed on the collected samples.

ReferenceCitation: Benetos A, Lai TP, Toupance S, Labat C, Verhulst S, Gautier S, Ungeheuer MN, Perret-Guillaume C, Levy D, Susser E, Aviv A. The Nexus Between Telomere Length and Lymphocyte Count in Seniors Hospitalized With COVID-19. J Gerontol A Biol Sci Med Sci. 2021 Jul 13;76(8):e97-e101. doi: 10.1093/gerona/glab026.

name: Université de Lorraine, Inserm, DCAC, Nancy, France

name: Université de Lorraine, CHRU-Nancy, Pôle “Maladies du Vieillissement, Gérontologie et Soins Palliatifs,” France

family: Benetos

full_name: Athanase Benetos

given: Athanase

name: Center of Human Development and Aging, Rutgers New Jersey Medical School, The State University of New Jersey, Newark, USA

family: Lai

full_name: Tsung-Po Lai

given: Tsung-Po

family: Toupance

full_name: Simon Toupance

given: Simon

family: Labat

full_name: Carlos Labat

given: Carlos

name: Groningen Institute for Evolutionary Life Sciences, University of Groningen, the Netherlands

family: Verhulst

full_name: Simon Verhulst

family: Gautier

full_name: Sylvie Gautier

given: Sylvie

name: Institut Pasteur, Clinical Investigation and Access to Bioresources Department, Paris, France

family: Ungeheuer

full_name: Marie-Noelle Ungeheuer

given: Marie-Noelle

family: Perret-Guillaume

full_name: Christine Perret-Guillaume

given: Christine

name: National Heart, Lung, and Blood Institute’s Framingham Heart Study, Massachusetts, USA

name: Population Research Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA

family: Levy

full_name: Daniel Levy

given: Daniel

name: Mailman School of Public Health, Columbia University, New York, New York, USA

name: New York State Psychiatric Institute, USA

family: Susser

full_name: Ezra Susser

given: Ezra

family: Aviv

full_name: Abraham Aviv

given: Abraham

journal_name: The Journals of Gerontology: Series A

lead_sponsor: Institut Pasteur

location_facility: Centre Hospitalier Départemental de Vendée


title: Prevalence of Covid-19 in Children Admitted to Paediatric Emergency Departments During the Pandemic Period in France

acronym: INCOVPED

summary: Arriving in December 2019, Coronavirus COVID-19 infection is causing a global pandemic with high morbidity and mortality among adults and especially seniors. The child appears little or no affected by this infection. It is estimated that the child could be asymptomatic or pauci-symptomatic carrier and thus be vector of the disease. For this reason, measures have been taken to close schools and contain populations in a large number of countries, including France. However, there are no data on the prevalence of COVID-19 in children.

lead_sponsor: University Hospital, Lille

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval


title: A Post-Authorisation Non-Interventional Observational, Multi-Site Study of Patients in France With Primary Biliary Cholangitis Treated With Obeticholic Acid in Real Life (OCARELIFE)

acronym: OCARELIFE

summary: Post-authorisation non-interventional observational study of patients with Primary Biliary Cholangitis who started Ocaliva® treatment between October 1st, 2016 and December 31, 2017.

time_perspective: Other

lead_sponsor: SAMEY

location_facility:
Hopital Saint Antoine
Chu Grenoble


title: Clinical and Medico-economical Assessment of Deep Brain Stimulation of the Anterior Nucleus of the Thalamus for the Treatment of Pharmacoresistant Partial Epilepsy

acronym: FRANCE

summary:
The main objective of the study is twofold:

Assess the clinical efficacy of DBS on epilepsy according to their number and severity at 1 year follow up.
Perform a cost-effectiveness analysis from the perspective of Medicare at 1 and 2 years.

The study hypothesis is that thalamic DBS (neurostimulation of the anterior nucleus of the thalamus) will decrease significantly, the frequency (potentially 50% reduction in severe crises) of the most severe seizures, in at least 50% of patients who have drug-resistant partial epilepsy; and should also improve significantly the quality of life through a gain of independence in activities of daily life, the possible recovery of functional abilities, recovery of social or professional activities.

ReferenceCitation: Chabardès S, Kahane P, Minotti L, Koudsie A, Hirsch E, Benabid AL. Deep brain stimulation in epilepsy with particular reference to the subthalamic nucleus. Epileptic Disord. 2002 Dec;4 Suppl 3:S83-93.

ReferenceCitation: Chabardès S, Minotti L, Chassagnon S, Piallat B, Torres N, Seigneuret E, Vercueil L, Carron R, Hirsch E, Kahane P, Benabid AL. [Basal ganglia deep-brain stimulation for treatment of drug-resistant epilepsy: review and current data]. Neurochirurgie. 2008 May;54(3):436-40. doi: 10.1016/j.neuchi.2008.02.039. Epub 2008 May 2. Review. French.

ReferenceCitation: Fisher R, Salanova V, Witt T, Worth R, Henry T, Gross R, Oommen K, Osorio I, Nazzaro J, Labar D, Kaplitt M, Sperling M, Sandok E, Neal J, Handforth A, Stern J, DeSalles A, Chung S, Shetter A, Bergen D, Bakay R, Henderson J, French J, Baltuch G, Rosenfeld W, Youkilis A, Marks W, Garcia P, Barbaro N, Fountain N, Bazil C, Goodman R, McKhann G, Babu Krishnamurthy K, Papavassiliou S, Epstein C, Pollard J, Tonder L, Grebin J, Coffey R, Graves N; SANTE Study Group. Electrical stimulation of the anterior nucleus of thalamus for treatment of refractory epilepsy. Epilepsia. 2010 May;51(5):899-908. doi: 10.1111/j.1528-1167.2010.02536.x. Epub 2010 Mar 17.

ReferenceCitation: Lim SN, Lee ST, Tsai YT, Chen IA, Tu PH, Chen JL, Chang HW, Su YC, Wu T. Electrical stimulation of the anterior nucleus of the thalamus for intractable epilepsy: a long-term follow-up study. Epilepsia. 2007 Feb;48(2):342-7.

lead_sponsor: University Hospital, Grenoble

location_facility: University Hospital of Grenoble Michallon

location_facility: University Hospital of La Pitié-Salpétrière

location_facility: University Hospital of Pierre Wertheimer


title: Non-interventional Study on the Safety and Use of Allergy Immunotherapy ACARIZAX® 12 SQ-HDM in Real-life Clinical Practice in Adult Patients With House Dust Mite Allergy in France

acronym: CARIOCA

summary: Non-interventional study to investigate the safety and tolerability of allergy immunotherapy ACARIZAX® 12 SQ-HDM in real-life clinical practice in adults patients (>18 years) with house dust mite allergy over a period of 12 months.

lead_sponsor: ALK-Abelló A/S