title: Epidemiology of Congenital Heart Disease in France : EPIDEMIO-CHD

acronym: EPIDEMIO-CHD

summary:
Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Since the 1980s, France has been a pioneer in neonatal CHD surgery (Pr. Fontan, Pr. Lecomte, Pr. Serraf, etc.), in prenatal diagnosis, and in interventional cardiac catheterization.

Actually, first children operated for complex CHD have reached adulthood and a new epidemiology of CHD is emerging. Currently, one of the public health challenges is the need to maintain appropriate follow-up and to avoid disruption of care during the transition from adolescence to adulthood. Thus, the national health authorities (DGOS) recently certified a national network of expert centers for complex CHD (M3C).

In addition, under the leadership of the French Society of Cardiology, the sub-specialty of Pediatric and Congenital Cardiology has been recognized.

However, while North American and North European countries have published their updated data on the main indicators of CHD morbidity and mortality, no study has reported epidemiology of CHD in France.

Currently, available data are approximate, estimating that 200,000 children and 250,000 adults would be living in France with a CHD. Nevertheless, no information is available on hospitalizations, type of CHD, their follow-up, possible disruption in care, and morbidity and mortality in patients with CHD in France. This epidemiological study will use the national health insurance hospital database to answer these questions.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

collaborators: National Reference Center for Complex Congenital Heart Disease, Marie-Lannelongue Medical and Surgical Center, Le Plessis Robinson

collaborators: National Reference Center for Complex Congenital Heart Disease, University Hospital of Bordeaux


title: Evaluation of Impact of Disease and Visual Disability on Quality of Life and Loss of Independence of Patients Living in France With Leber's Hereditary Optic Neuropathy (LHON) Through Qualitative and Quantitative Data Collection

summary:
Leber's hereditary optic neuropathy (LHON) is a rare mitochondrial genetic disorder characterized by optic nerve atrophy due to the degeneration of retinal ganglion cells, which leads to acute visual loss.

Males are more likely to develop optic neuropathy than women. They experience blurring or clouding of vision in one eye. The fellow eye develops similar symptoms sequentially with a delay of weeks.

This sudden vision loss has devastating consequences on the life course of young men, with the impact of LHON on their quality of life and loss of independence.

Yet, data describing the impacts of LHON on the life-course of patients is lacking, with very little data available in the literature.

This study aims to understand the life of patients living with LHON disease through the analysis of the impact of LHON on the quality of life and loss of independence of patients living in France and to accurately describe the consequences of the disease on their social, familial and professional life.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Cui S, Jiang H, Peng J, Wang J, Zhang X. Evaluation of Vision-Related Quality of Life in Chinese Patients With Leber Hereditary Optic Neuropathy and the G11778A Mutation. J Neuroophthalmol. 2019 Mar;39(1):56-59. doi: 10.1097/WNO.0000000000000644.

ReferenceCitation: Kirkman MA, Korsten A, Leonhardt M, Dimitriadis K, De Coo IF, Klopstock T, Griffiths PG, Hudson G, Chinnery PF, Yu-Wai-Man P. Quality of life in patients with leber hereditary optic neuropathy. Invest Ophthalmol Vis Sci. 2009 Jul;50(7):3112-5. doi: 10.1167/iovs.08-3166. Epub 2009 Feb 28.

ReferenceCitation: Newman NJ. Hereditary optic neuropathies: from the mitochondria to the optic nerve. Am J Ophthalmol. 2005 Sep;140(3):517-23. doi: 10.1016/j.ajo.2005.03.017.

ReferenceCitation: Newman NJ, Yu-Wai-Man P, Carelli V, Biousse V, Moster ML, Vignal-Clermont C, Sergott RC, Klopstock T, Sadun AA, Girmens JF, La Morgia C, DeBusk AA, Jurkute N, Priglinger C, Karanjia R, Josse C, Salzmann J, Montestruc F, Roux M, Taiel M, Sahel JA. Intravitreal Gene Therapy vs. Natural History in Patients With Leber Hereditary Optic Neuropathy Carrying the m.11778G>A ND4 Mutation: Systematic Review and Indirect Comparison. Front Neurol. 2021 May 24;12:662838. doi: 10.3389/fneur.2021.662838. eCollection 2021.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

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

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: California Digital Library - eScholarship

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central
UCL Discovery
escholarship.org

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

ReferenceCitation: Yu-Wai-Man P, Turnbull DM, Chinnery PF. Leber hereditary optic neuropathy. J Med Genet. 2002 Mar;39(3):162-9. doi: 10.1136/jmg.39.3.162.

ipd_sharing: No

lead_sponsor: Argo Sante

sponsor_collaborators:
Argo Sante
GenSight Biologics

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Impact of COVID-19 on Unplanned Admissions for Acute Cardiovascular and Neurovascular Conditions in France

acronym: COVUSI

summary:
The COVID-19 pandemic has had dramatic effects on health systems and on non-COVID health care.

Using French inpatient claims data and retrospectively collected clinical data, the investigators will assess the changes in hospital admissions for acute cardiovascular and neurovascular conditions in France during and after the national lockdown.

status: Terminated

study_completion_date_type: Actual

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor_type: academique

status_simplified: Unknown


type: Registry Identifier

title: Epidémiologie et Conditions de Vide liées au Covid-19 STUDY OF THE COVID-19 (SARS-CoV-2) EPIDEMIC AND SOCIO-ECONOMIC LIVING

acronym: EpiCov

summary: EpiCov is a population-based cohort which aims to provide national and regional estimates of seroprevalence of SARS-CoV-2 infection and analyse relations between living conditions and the dynamics of the epidemic in France. The study population is a random sample of individuals aged 15 years and older, excluding people living in residences for the elderly and living in jail. The participants are recruited from the French national tax register and is representative of the population living in France. Home self-samples on Dried Blood Spots (DBS) for IgG and neutralizing antibodies detection were offered to a random national sub-sample of 12,114 in the 1st round of the EPICOV survey (May 2020) and to all respondents in the 2nd round (November 2020), including also serological testing for all members (≥ 6 years old) of household for 20% of index participants. A third round was perfomed in June-July 2021, without serological measurements. Overall, 134,391 participants have been enrolled in first-round (May 2020). Among them, 107 759 participated to the second round (November 2020) and 85 074 in third round (June 2021). The next wave is expected in March-april 2022.

time_perspective: Prospective

ipd_sharing: Yes

ipd_sharing_description:
The EpiCov data is available for research purpose, 9 months after overall completion of one round. Access to anonymized individual data may be available before the planned period of open access : specific project has to be presented to the EpiCov exploitation committee : if accepted, it needs approval of ethics and reglementary Committee for researchers who meet the criteria for access to data.

The first round, and will be available by March 2022 concerning the second round for research purpose on CASD (https://www.casd.eu/), after submission to approval of French Ethics and Regulatory Committee procedure (Comité du Secret Statistique, CESREES and CNIL).

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


title: Non-interventional Study Describing Epidemiology, Clinical Characteristics, Prognosis and Healthcare Costs of PF-ILD and SSc-ILD Patients in France, 2010-2017

acronym: PROGRESS

summary:
Interstitial lung diseases (ILDs) are a heterogeneous group of disorders, which encompass a wide range of conditions. In some patients with fibrosing ILDs, a progressive phenotype similar to that observed in idiopathic pulmonary fibrosis (IPF) may develop during the course of the disease (PF-ILD), including patients with systemic sclerosis (SSc)-related ILD.

The aim of the study is to estimate the incidence and prevalence and to describe the characteristics of patients diagnosed with non-IPF PF-ILD and SSc-ILD, to describe the natural course of disease, and to explore the correlation between mortality and Forced Vital Capacity (FVC) of the patients with non-IPF PF-ILD.

This study will be based on two data sources: the French national medico administrative database (SNDS) and the ILD cohort from the National French center for rare pulmonary diseases in Lyon, France.

study_start_date_type: Anticipated

status: Unknown status

ReferenceType: derived

ReferenceCitation: Cottin V, Larrieu S, Boussel L, Si-Mohamed S, Bazin F, Marque S, Massol J, Thivolet-Bejui F, Chalabreysse L, Maucort-Boulch D, Jouneau S, Hachulla E, Chollet J, Nasser M. Epidemiology, Mortality and Healthcare Resource Utilization Associated With Systemic Sclerosis-Associated Interstitial Lung Disease in France. Front Med (Lausanne). 2021 Aug 30;8:699532. doi: 10.3389/fmed.2021.699532. eCollection 2021.

repository_institution: PubMed Central - Europe PMC

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

ReferenceCitation: Nasser M, Larrieu S, Boussel L, Si-Mohamed S, Bazin F, Marque S, Massol J, Thivolet-Bejui F, Chalabreysse L, Maucort-Boulch D, Hachulla E, Jouneau S, Le Lay K, Cottin V. Estimates of epidemiology, mortality and disease burden associated with progressive fibrosing interstitial lung disease in France (the PROGRESS study). Respir Res. 2021 May 24;22(1):162. doi: 10.1186/s12931-021-01749-1.

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

publisher_dissemination: Springer-Nature

ReferenceCitation: Nasser M, Larrieu S, Si-Mohamed S, Ahmad K, Boussel L, Brevet M, Chalabreysse L, Fabre C, Marque S, Revel D, Thivolet-Bejui F, Traclet J, Zeghmar S, Maucort-Boulch D, Cottin V. Progressive fibrosing interstitial lung disease: a clinical cohort (the PROGRESS study). Eur Respir J. 2021 Feb 11;57(2):2002718. doi: 10.1183/13993003.02718-2020. Print 2021 Feb.

oa_colors: green hybrid

evidence: open (via crossref license)


title: Statins and Risk of Myocardial Infarction in Real Life in France

summary: The main objective of this case-referent study is to assess the impact of statins usage on the risk of having a first myocardial infarction (MI) in a real life situation in France

status: Completed

lead_sponsor: AstraZeneca

status_simplified: Completed


title: Genetic Polymorphisms in Idiopathic Mitral Valve Prolapse :A French Prospective Study Using a Genome Wide Analysis

acronym: MVP-France

summary: This prospective nation-wide (France) study aims to search for susceptibility genes in MVP using a genome wide analysis and comparing results obtained in 1000 patients with MVP and 1000 non-MVP subjects.

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Screening

lead_sponsor: French Cardiology Society

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

location_facility:
Hôpital Ambroise Paré
Hôpital Européen Georges Pompidou
Hôpital Front-Pré
Hôpital de la Cavale Blanche
Hôpital Sud
Hôpital du Bocage
Hôpital Pitié Salpêtrière
Hôpital Bichat
Hôpital G and R Laennec
Clinique Saint Augustin
Hôpital de la Timone
Hôpital Charles Nicolle
CHU Nancy
Groupement Hospitalier Est
Hôpital Rangueil
Hôpital Cochin
Hôpital Cardiologique du Haut Lévêque
Hôpital Pontchaillou
Hôpital Gabriel Montpied
Hôpital Henri Mondor
Hôpital Saint Antoine
Hôpital Arnaud de Villeneuve
Hôpital Lariboisière
Hôpital Dupuytren
Institut Hospitalier Jacques Cartier
Hôpital Cardiologique

intervention_type: Genetic


title: Evaluation of Impact of Disease on Quality of Life, Education and Socio-professional Integration of Adults and Parents of Children Living With Sickle- Cell Disease in France

acronym: DREPAtient

summary:
Sickle cell disease (SCD) is the most common genetic disease in France. Its consequences on patient's life-course and quality of life need to be precisely identified among French patients and their family to be able to improve patients care according to their specific needs.

The aim of the study is to accurately describe the impact of SCD on quality of life of patients living in France, or their family (for minor patients). The consequences of the disease on professional life, education and material condition of patients or their parents will be described by the patients themselves.

ReferenceCitation: Crosby LE, Joffe NE, Irwin MK, Strong H, Peugh J, Shook L, Kalinyak KA, Mitchell MJ. School Performance and Disease Interference in Adolescents with Sickle Cell Disease. Phys Disabil. 2015;34(1):14-30. doi: 10.14434/pders.v34i1.13918.

ReferenceCitation: Dos Santos JP, Gomes Neto M. Sociodemographic aspects and quality of life of patients with sickle cell anemia. Rev Bras Hematol Hemoter. 2013;35(4):242-5. doi: 10.5581/1516-8484.20130093.

ReferenceCitation: Gardner K, Douiri A, Drasar E, Allman M, Mwirigi A, Awogbade M, Thein SL. Survival in adults with sickle cell disease in a high-income setting. Blood. 2016 Sep 8;128(10):1436-8. doi: 10.1182/blood-2016-05-716910. Epub 2016 Jul 20. No abstract available.

ReferenceCitation: Habibi A, Arlet JB, Stankovic K, Gellen-Dautremer J, Ribeil JA, Bartolucci P, Lionnet F; centre de reference maladies rares << syndromes drepanocytaires majeurs >>. [French guidelines for the management of adult sickle cell disease: 2015 update]. Rev Med Interne. 2015 May 11;36(5 Suppl 1):5S3-84. doi: 10.1016/S0248-8663(15)60002-9. French.

ReferenceCitation: Chapelon E, Garabedian M, Brousse V, Souberbielle JC, Bresson JL, de Montalembert M. Osteopenia and vitamin D deficiency in children with sickle cell disease. Eur J Haematol. 2009 Dec 1;83(6):572-8. doi: 10.1111/j.1600-0609.2009.01333.x. Epub 2009 Aug 13.

ReferenceCitation: Godeau B, Noel V, Habibi A, Schaeffer A, Bachir D, Galacteros F. [Sickle cell disease in adults: which emergency care by the internists?]. Rev Med Interne. 2001 May;22(5):440-51. doi: 10.1016/s0248-8663(01)00369-1. French.

ReferenceCitation: LINDENBAUM J, KLIPSTEIN FA. FOLIC ACID DEFICIENCY IN SICKLE-CELL ANEMIA. N Engl J Med. 1963 Oct 24;269:875-82. doi: 10.1056/NEJM196310242691701. No abstract available.

ReferenceCitation: Noll RB, Vannatta K, Koontz K, Kalinyak K, Bukowski WM, Davies WH. Peer relationships and emotional well-being of youngsters with sickle cell disease. Child Dev. 1996 Apr;67(2):423-36. doi: 10.1111/j.1467-8624.1996.tb01743.x.

ReferenceCitation: Salih KMA. The impact of sickle cell anemia on the quality of life of sicklers at school age. J Family Med Prim Care. 2019 Feb;8(2):468-471. doi: 10.4103/jfmpc.jfmpc_444_18.

ReferenceCitation: Sehlo MG, Kamfar HZ. Depression and quality of life in children with sickle cell disease: the effect of social support. BMC Psychiatry. 2015 Apr 11;15:78. doi: 10.1186/s12888-015-0461-6.

collaborators: Fédération des malades drépanocytaires et thalassémiques SOS Globi

location_facility: Centre de références syndromes drépanocytaires majeurs thalassémie et autres maladies rares du globule rouge et de l'érythropoïése


title: Serotype Distribution in Hospitalized Adult With Pneumococcal Community Acquired Pneumonia in France

acronym: CAP'Hospi

summary: CAP'Hospi is an observational, multicentric study in France which primary objective is to describe the proportion of Community Acquired Pneumonia due to serotypes included in PCV20 among adults hospitalized for CAP

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


title: Validation of the Hospital Frailty Risk Score in Combination With Charlson/Elixhauser Comorbidity Coding Algorithms on French Hospital Databases

acronym: HFRS France

summary: Older people are increasing users of health care globally. Constraints in bed capacity and resources raise important challenges with regards to management of older people with complex needs, which usually require assertive and holistic assessment. It is important, therefore, to identify aged patients most likely to benefit from such frailty-attuned approaches of care. A previous study using national Hospital Episodes Statistics conducted in the United Kingdom (UK) showed that patients aged over 75 years with characteristics of frailty and at risk of adverse health-care outcomes can be identified using routinely collected data (Gilbert T et al., Lancet 2018). This study lead to the development of the Hospital Frailty Risk Score (HFRS), which is based on International Statistical Classification of Diseases and Related Health Problems 10 (ICD-10) diagnosis codes and has the potential to be used in other countries worldwide, using the ICD-10 coding framework, to identify patients at risk of frailty at the hospital and commissioners levels, as well as for database research purposes. This score has successfully been validated in Canada, Australia and Switzerland. The aim of the present study is to evaluate the ability of the HFRS to predict 30-day in-patient mortality of patients aged 75 years and older admitted to French hospitals as an emergency.

ReferenceCitation: Gilbert T, Cordier Q, Polazzi S, Bonnefoy M, Keeble E, Street A, Conroy S, Duclos A. External validation of the Hospital Frailty Risk Score in France. Age Ageing. 2022 Jan 6;51(1):afab126. doi: 10.1093/ageing/afab126.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repository_institution: London School of Economics and Political Science - London School of Economics and Political Science Research Online

version: acceptedVersion

repositories_institution: University College London - UCL Discovery

unpaywall_oa_status: hybrid

publisher_dissemination: Oxford University Press

lead_sponsor: Hospices Civils de Lyon

location_facility: service de court séjour gériatrique, Hôpital Lyon Sud

intervention_type: Other


title: Acid Sphingomyelinase Deficiency (ASMD): Data Analysis of Adult and Pediatric Patients on Early Access to Olipudase Alfa in France

acronym: OPERA

summary:
Primary Objective:

To describe the lung, spleen and liver outcomes of olipudase alfa

Secondary Objectives:

To describe the patient's characteristics
To describe conditions of olipudase alfa use
To describe safety data related to the use of olipudase alfa
To describe complementary effectiveness outcomes parameters

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi

intervention_type: Drug


title: Epidemiological Data on Mast Cell Pathologies in France

acronym: DATAMAST

summary:
Mast cell disorders constitute a heterogeneous group of diseases, including :

mastocytosis, i.e. cutaneous, indolent and severe forms of the disease, such as aggressive mastocytosis and mast cell leukemia) ;
mast cell-associated diseases such as mast cell activation syndrome (idiopathic, secondary or clonal), affecting both children and adults.

No epidemiological data are currently available in France.

In France, medical care of mast cell disorders is mainly provided by a rare disease network (CEREMAST), whose CRMR is located at the Necker Enfants Malades hospital in Paris. A total of 20 centers are located throughout France.

Our aim is to use this network to study patients suffering from these diseases. The overall aim of the study is to improve the understanding, diagnosis, prognosis, recognition and management of patients with mastocytosis.

status: Not yet recruiting

time_perspective: Cross-Sectional

lead_sponsor: Imagine Institute


title: Cardiovascular Risk in General Practice in France

summary: The purpose of this study is to evaluate the proportion of patients which present a high cardiovascular risk estimated by the SCORE scale, in general practice consultations of the 7 French regions (Paris area, North-East, Paris basin, West, South-West, South- East, Mediterranean area)


type: Other Identifier

title: Feasibility in France of a Mindfulness-based Group Therapy for Adolescents With Chronic Pain

acronym: PEACEFULL

summary: The main objective is to study the feasibility of a program for the management of chronic painful adolescents in meditation groups. This program is an adaptation of the MBI-A (Mindfulness-based intervention for adolescent) program developed in another socio-cultural context (i.e. in Canada). The secondary objectives will be to study the effect of a mindfulness meditation program for adolescents on pain, quality of life, acceptance of pain, functional disability, catastrophism, anxiety-depression, emotional repercussions and acceptance of mindfulness

primary_purpose: Other

ReferenceCitation: Bawa FL, Mercer SW, Atherton RJ, Clague F, Keen A, Scott NW, Bond CM. Does mindfulness improve outcomes in patients with chronic pain? Systematic review and meta-analysis. Br J Gen Pract. 2015 Jun;65(635):e387-400. doi: 10.3399/bjgp15X685297.

ReferenceCitation: Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.

ReferenceCitation: Zenner C, Herrnleben-Kurz S, Walach H. Mindfulness-based interventions in schools-a systematic review and meta-analysis. Front Psychol. 2014 Jun 30;5:603. doi: 10.3389/fpsyg.2014.00603. eCollection 2014.

ReferenceCitation: Hesse T, Holmes LG, Kennedy-Overfelt V, Kerr LM, Giles LL. Mindfulness-Based Intervention for Adolescents with Recurrent Headaches: A Pilot Feasibility Study. Evid Based Complement Alternat Med. 2015;2015:508958. doi: 10.1155/2015/508958. Epub 2015 Dec 22.

ReferenceCitation: Chadi N, McMahon A, Vadnais M, Malboeuf-Hurtubise C, Djemli A, Dobkin PL, Lacroix J, Luu TM, Haley N. Mindfulness-based Intervention for Female Adolescents with Chronic Pain: A Pilot Randomized Trial. J Can Acad Child Adolesc Psychiatry. 2016 Fall;25(3):159-168. Epub 2016 Nov 1.

ReferenceCitation: Ruskin D, Harris L, Stinson J, Kohut SA, Walker K, McCarthy E. "I Learned to Let Go of My Pain". The Effects of Mindfulness Meditation on Adolescents with Chronic Pain: An Analysis of Participants' Treatment Experience. Children (Basel). 2017 Dec 15;4(12):110. doi: 10.3390/children4120110.

ReferenceCitation: Ruskin DA, Gagnon MM, Kohut SA, Stinson JN, Walker KS. A Mindfulness Program Adapted for Adolescents With Chronic Pain: Feasibility, Acceptability, and Initial Outcomes. Clin J Pain. 2017 Nov;33(11):1019-1029. doi: 10.1097/AJP.0000000000000490.

lead_sponsor: University Hospital, Toulouse


title: Awareness, Care & Treatment In Obesity Management - An Observation in France

acronym: ACTION-France

summary:
ACTION France is a cross-sectional, observational, descriptive, and exploratory survey-based study without collection of laboratory data. The study is not related to any specific treatment options or pharmaceutical product. Collection of data will be performed via quantitative online survey by a third-party vendor.

The goal of this study is to provide insights to drive awareness around the needs of People Living with Obesity (PLwO) and Health Care Professionals (HCPs) involved in obesity treatment and management.

ipd_sharing_description: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

lead_sponsor: Novo Nordisk A/S


title: Registre Wilson France

acronym: WIL-FR

summary: This registry concerns adults and children with Wilson's disease. The collection of a large amount of data will allow a better understanding of the epidemiology of this rare disease, in particular the age of onset according to the hepatic or hepato-neurological forms, but also the geographical distribution of patients consulting in France. This database will also make it possible to know all the therapies prescribed to "Wilsonian" patients. The genetic study of these patients will make it possible to specify the various genetic mutations involved in Wilson's disease. The information (clinical, biological, radiological and genetic) relating to the disease will be entered by a doctor or a professional specialising in Wilson's disease.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Epi-Hypo: Survey on Epidemiology of Hypoparathyroidism in France

acronym: Epi-Hypo

summary: Very few data has been published on the epidemiology of hypoparathyroidism worldwide: none exists specifically for France. Hypoparathyroidism could led to complications. Here, the investigators plan to collect data about both epidemiology, medication and complication of hypoparathyroidism in France.

lead_sponsor: European Georges Pompidou Hospital

sponsor_collaborators:
European Georges Pompidou Hospital
Oscar - Filière Santé Maladies Rares

location_facility: European Georges Pompidou Hospital, APHP


title: Retrospective Study of Clinical Practice and Management of Imported Schistosomiasis in France

acronym: RETROBIZH

summary: Schistosomiasis is a major public health issue. Clinical guidelines for the management of imported schistosomiasis are heterogeneous. The objective of this study is to describe the clinical management of schistosomiasis imported cases in France, regarding diagnosis, treatment and follow-up.

ipd_sharing_description: No sharing

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Perceptions, Representations and Experiences of Malaria Prophylaxis in Patients Born in Endemic Areas and Living in France.

acronym: PREPAP

summary:
The aim of this study is to analyze the perceptions, representations and expe-riences of malaria prophylaxis in patients born in endemic areas and living in France.

This analysis could lead to better understanding and communication between the medical profession and patients in malaria. It would also provide patient-specific responses to their expectations, as to their families.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre hospitalier intercommunal de Villeneuve St Georges


title: Prevalence Survey in France of Unintentional Perioperative Hypothermia and Its Impact on Two Outcomes: Blood Loss, Myocardial Injury After Non Cardiac Surgery

acronym: HYPOTHERMIE

summary:
The primary objectives of the study are

to perform a survey on the clinical management of unintentional hypothermia during surgery in France.
to assess the impact of perioperative hypothermia on anemia and myocardial injury.

lead_sponsor: Société Française d'Anesthésie et de Réanimation

location_facility: Service d'Anesthésie-Réanimation Chirurgicale, Hôpital Cochin


title: Epidemiology and Clinical Presentation of Human Anaplasmosis in Eastern France

summary: Anaplasmosis is a tick-borne transmitted infection. Its clinical expression include fever, cytopenia and hepatitis.This infection was initially described in United States. In Europe, its epidemiology is not well known. Some isolated cases have been diagnosed in several country, were the tick Ixodes ricinus is known to transmitted another infection :the Lyme borreliosis.The purpose of our study is to look systematically for Anaplasmosis, in patient living in Eastern France, and presenting with compatible clinical symptoms using a new diagnosis tool : PCR in blood samples. So we will have new data about epidemiology in our country and the clinical symptoms that are associated with Anaplasmosis.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service de Médecine Interne et Maladies Infectieuses - CHU de Reims

location_facility: Service des Maladies Infectieuses et Tropicales Hôpitaux Universitaires de Strasbourg

location_facility: Département d'Infectiologie CHU de Dijon

location_facility: Service des Maladies Infectieuses et Tropicales - CHU de Besançon

location_facility: Service des Maladies Infectieuses et Tropicales - CHU de Nancy

intervention_type: Procedure


title: Prevalence and Risk Factors for Coxiella Burnetii Seropositivity (Q Fever) Among Adults in Western France

acronym: MEDVETFQ

summary:
Diseases naturally transmitted between animals and humans (zoonoses) are one of the leading causes of emergence or re-emergence of human infectious diseases. Non-foodborne zoonoses are commonly transmitted to human directly by contact with infected animals or contaminated environment. People working with animals such as farmers and veterinarians are particularly at risk of infection. Some zoonoses can also be transmitted indirectly thought the air and therefore can affect the general population. Example is Q fever, a disease caused by Coxiella burnetii, a bacterium highly resistant in the environment.

In Western France, Q fever is endemic in cattle herds. To improve human zoonotic disease surveillance, the investigators will conduct a population based study in this area.

The aims of the study are:

To assess seroprevalence of Coxiella burnetii infection among general population, farmers and veterinarians in Western France
To identify risk factors for Coxiella burnetii seropositivity in these populations

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
ONIRIS


title: Prospective Observational Study to Describe Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France and Its Use in Routine Clinical Practice

acronym: PILOTE

summary: The purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with Prolia in France, and examine the use of Prolia in routine clinical practice in France

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen


title: Population Genomic Diversity of France

acronym: POPGEN

summary:
Having access to DNA sequences from individuals that share common ancestry with patients is of interest when analysing individual genomes for diagnoses. Information regarding allele frequency distribution in the same geographic areas where patients have ancestry will be necessary to help select the variants that are the most likely involved in disease and should hence be tested in functional assays.

To provide such a general population panel for France, the POPGEN project will select 10,000 individuals from CONSTANCES cohort with ancestry in different regions of France outside western part. These participants will have their DNA extracted from salivary kits and genotyped using SNP-chip. Among these 10,000 individuals, 4,000 individuals will have their whole genome sequenced. This study is one of the four pilot projects of the France Genomic Medicine plan (FMG 2025). The FMG2025 plan aims at introducing genome sequencing in the routine clinical practice to accelerate and improve diagnoses. The POPGEN project will provide the required references from the general French population to help filter out common variants from the genomes of patients.

status: Active, not recruiting


title: Kidney Transplant Outcome and Organ Acceptance Practice Pattern: A Nationwide Analyses in the US and France

acronym: USFRKT

summary:
Despite the considerable advances in short-term outcomes, kidney transplant recipients continue to suffer from late allograft failure, and little improvement has been made over the past 15 years. The worldwide scarcity of donated kidneys and the decline in the number of living donor transplants have prompted a variety of efforts to expand the organ supply, such as accepting organs from donors who were older or had comorbidities or other injuries.

Two major initiatives from the United Network for Organ Sharing (UNOS), the organization responsible for organ allocation in the US, failed to improve the kidney acceptance rate. First, UNOS introduced the Kidney Donor Risk Index (KDRI) for all kidney offers in 2012. The KDRI is a score that predicts survival of deceased donor kidneys based on 10 donor characteristics and was intended to simplify the process of judging organ quality for clinicians. Second, in 2014, UNOS changed the kidney allocation system so that lower-quality kidneys are offered over wider geographic areas. Despite the ongoing severe organ shortage and these allocation initiatives, the number of discarded kidneys rose from 2,127 (14.9%) in 2006 to 3,631 (20%) in 2016. In this context, the experience of transplant programs outside the US could offer novel approaches to making organ utilization more efficient through the examination of the disposition of organs that are usually discarded in the US.

This project aims:

To evaluate the potential benefit of transplanting kidneys that would have been discarded otherwise in the US
Computer simulation models on real life data to estimate the number of kidney transplants that would have taken place using data from a nationwide cohort study in two countries (France, the US);
To evaluate the potential gains in allograft survival years that would result in the US from a less restrictive kidney acceptance practice such as the one from France.

time_perspective: Other

ReferenceCitation: Aubert O, Reese PP, Audry B, Bouatou Y, Raynaud M, Viglietti D, Legendre C, Glotz D, Empana JP, Jouven X, Lefaucheur C, Jacquelinet C, Loupy A. Disparities in Acceptance of Deceased Donor Kidneys Between the United States and France and Estimated Effects of Increased US Acceptance. JAMA Intern Med. 2019 Oct 1;179(10):1365-1374. doi: 10.1001/jamainternmed.2019.2322.

evidence: open (via free pdf)

repositories_concat: PubMed Central

publisher_dissemination: American Medical Association

lead_sponsor: Paris Translational Research Center for Organ Transplantation

collaborators:
University of Pennsylvania
Agence de La Biomédecine

location_country:
United States
France

location_facility: Kidney Transplantation Care at Veteran's Affairs Medical Center


title: Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France

acronym: SALTO

summary:
Childhood cancers are rare, and today 75% of patients survive them. An estimated one out of 850 French persons has survived childhood cancer. However, the complications of chemotherapy, radiotherapy or surgery can lead to a higher risk of secondary mortality, which the literature estimates is at 14%. Regular care has a positive impact on the quality of life and health of adults who survived cancer during their childhoods. It aims to detect the potential long-lasting effects of cancer and to provide therapeutic education and psychological care. Thanks to cancer registries, several countries (USA, Canada, UK, Germany, the Netherlands) have developed long-term care structures which function with specially trained adult medicine practitioners. There are only two structures in France: the Long-Term Oncology/Hematology Follow-Up Clinic, headed by Dr François Pein, in Nantes (France), and the LEA program for the follow-up of children treated for leukemia in the PACA-Corse and Lorraine regions of France, which began in 2003 and has since been extended to other centers.

The Rhône-Alpes and Auvergne regions have had childhood cancer registries since 1987; they compile about 200 new cases a year. The Rhône-Alpes registry has conducted a preliminary trial on children (0-15 years old) diagnosed with cancer between 1987 and 1992. They analyzed the correlation between patients' quality of life and the long-term medical effect of cancer and treatment, both recorded in patients' medical files and declared by patients. These young adults who survived pediatric cancer appear to suffer from and declare many complications, although this does not impact their global quality of life much. There is a negative correlation between the number of complications (observed or declared) and the global quality of life score, but only three types of complications play a significant role (motor function complications, auditory complications, and alopecia.) In addition, there is a significant mismatch between patients's perceived health (what they say they experience), and the information contained in their medical files. These young adults expressed the need for their impressions to be better taken into account by health care professionals. This study does not assess patients' psychopathological characteristics.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
IHOP
CHU de Clermont-Ferrand
CHU de Saint-Etienne
CHU de Grenoble


title: TIBOLA : Multicenter Descriptive Study in Eastern France

summary:
TIBOLA (TIck-BOrne LymphAdenopathy) is a tick-borne disease. The pathogen is most often rickettsia (R. slovaca or R. raoultii), but other strict intracellular bacteria have been described (Francisella tularensis, Coxiella burnetii, Bartonella hensenlae).

Transmitted by ticks (Dermacentor), it is characterized by an inoculation eschar at the tick bite site, accompanied by painful loco-regional lymphadenopathy. It is most often a benign pathology, which can nevertheless leave sequellar alopecia or persistent asthenia.

In spring 2021, an impression of increased cases was reported by clinicians in Eastern France. The study aims to clarify the clinical-biological presentation and the evolution of the number of cases of TIBOLA in this region between 2016 and 2021.

At the same time, entomologists have noted an upsurge in this tick in certain biotopes in recent years.

lead_sponsor: Central Hospital, Nancy, France

location_facility:
Elisabeth Baux
Yves Hansmann


title: Medically Assisted Procreation and Choice of the Embryo: How Far Would French People Like to go - An Opinion Survey Among Patients Resorting to in Vitro Fertilization (IVF) in France.

summary:
In today's context of bioethics laws revision concerning Medically Assisted Procreation, the investigators focus on the opinion of couples resorting to In Vitro Fertilization on a fundamental, much debated issue ; the choice of the embryo.

French lawmakers fear the investigators might be drifting towards embryo selection procedures, but no study allows us to state this is what patients request. This study aims at determining, among the population of patients who resort to Medically Assisted Procreation in France, the ratio of patients who are willing to select the embryo due to its genetic characteristics.

lead_sponsor: University Hospital, Montpellier


title: Impact of E-reporting by Patients With Relapsing-remitting Multiple Sclerosis on the Reporting of Adverse Drug Reactions in France: a Randomized Controlled Trial.

acronym: VigiP-SEP

summary:
Adverse drug reactions are collected exhaustively during the experimental development phase of the drug, but the trial population is not representative. In post-marketing authorization, the use in the real life of medicines requires to specify the profile of adverse effects through pharmacovigilance. However, in clinical practice, under-reporting of adverse drug reactions prevents a satisfactory knowledge of the risks. For example, in the multiple sclerosis (MS) patients population in 2015, only 1 case of congestive flushing was reported by physicians, none by patients, for approximately 7,800 patients treated with Tecfidera® dimethyl-fumarate, while trials reported 39% of flush.

The investigators propose a study measuring the impact of the deployment of e-reporting to patients in a population suffering from multiple sclerosis in initiation of first line drug therapy. The study design will be a randomized controlled trial. Twenty-four direct or indirect partner centers of the OFSEP will be randomized in 2 arms (1 standard arm without intervention, and one interventional arm), Each arm including 6 CHU, 3 CHG and 3 liberal neurologists. CHUs will include 10 patients in 6 months, and CHGs and liberal neurologists 5 patients, a total of 180 patients will be included. The expected duration of this study is 12 months, 6 months of inclusion of patients, and one 6-month follow-up period for each patient. At 1 month (+/- 15 days) of the follow-up period of each patient, a questionnaire will be made by telephone call to each patient.

The study is part of the pharmacovigilance system in place in France and aims to improve its efficiency by increasing declarations and therefore earlier detection of signals in order to prevent and minimize risks.

The comparison of the two arms should make it possible to decide on the usefulness of national support for e-reporting, while respecting a good integration with the French pharmacovigilance system.

design_allocation: Randomized

ReferenceCitation: Defer G, Fedrizzi S, Chevanne D, Montastruc F, Briant AR, Parienti JJ, Peyro-Saint-Paul L; French VigipSEP Study Group; Societe Francophone de la Sclerose en Plaques (SFSEP). Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial. Drug Saf. 2021 Feb;44(2):223-233. doi: 10.1007/s40264-020-01009-z. Epub 2020 Oct 13.

oa_host_type: closed

repositories_concat: closed

lead_sponsor: University Hospital, Caen


title: Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France

acronym: SISTOLA

summary: The purpose of this study is to describe the way candesartan is used in heart failure treatment in France (treatment initiation and monitoring), treatment stops occurrence and reasons for and patients clinical evolution

lead_sponsor: AstraZeneca

sponsor_collaborators: AstraZeneca Takeda


title: Study of Symptoms Linked to Covid-19 in Residents and Professionals in EHPAD, Associated With a Dual Diagnostic Approach by PCR and Serology: a Cohort in Île-de-France.

acronym: COVID - EHPAD

summary: The main purpose is to study the prevalence of Covid-19 in EHPAD. The primary endpoint will be the combination of PCR results and symptomatology, making it possible to define positive cases in EHPAD, in residents and professionals in contact with them. The prevalence obtained can be compared with the results of serology if these are performed.

lead_sponsor: Gérond'if


title: Specificities of Quality of Life and Influence of Participation on the Quality of Life of the Adult With Spinal Muscular Atrophy in France: a Cross-sectional Study

acronym: QOLSMA

summary:
Spinal muscular atrophy is a hereditary motorneuron disease caused by a mutation of the SMN1 gene, which is at the origin of a progressive limb and axial motor deficiency. It concerns 1200 individuals in France, including 700 adults in 2018. The main objective of this study is to assess the quality of life of SMA patients in France.

The secondary objectives are, in one hand, to compare the quality of life of SMA patients to a population of neuromuscular diseases patients. And on the other hand to evaluate the determinants of participation and the impact of participation on quality of life in adult SMA patients.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service L'Escale - Médecine Physique et de Réadaptation Pédiatrique Groupement Hospitalier Est des Hospices Civils de Lyon


title: Descriptive Pharmacoepidemiological Study on the Use of Symbicort Turbuhaler in the Treatment of Asthma in France and Impact of a New Therapeutic Strategy on the Compliance and Control of Asthma

acronym: SYMBIOSE

summary: Descriptive pharmacoepidemiological study on the use of Symbicort Turbuhaler in the treatment of asthma in France and impact of a new therapeutic strategy on the compliance and control of asthma


title: Prevalence of Geophagy and Knowledge About Its Health Effects Among Native Sub-Saharan Africa, Caribbean and South America Healthy Adults Living in France

acronym: Prevalgeophagy

summary: Since geophagy is widespread among women from Sub-Saharan Africa, South America and the Caribbean, we aimed to determine the frequency of geophagy and the level of knowledge about its health effects among healthy adults originating from these countries and attending a travel medicine and international vaccination consultation in France.

ReferenceCitation: Decaudin P, Kanagaratnam L, Kmiec I, Nguyen Y, Migault C, Lebrun D, Hentzien M, Bertin E, Drame M, Bani-Sadr F. Prevalence of geophagy and knowledge about its health effects among native Sub-Saharan Africa, Caribbean and South America healthy adults living in France. Eat Weight Disord. 2020 Apr;25(2):465-469. doi: 10.1007/s40519-018-0624-9. Epub 2018 Dec 13.

lead_sponsor: CHU de Reims


title: Multicentric Cohort of Melanoma Patients in Ile de France Area

acronym: Melan-Cohort

summary: This is a multicentric prospective cohort of all stage melanoma patients from AP-HP ,the largest consortium of University hospitals over Europe. 7 investigation sites (7 dermatological services of AP-HP) in Ile de France region are involved. 1300 patients will be enrolled and be followed during 10 years.


title: Overdiagnosis of Thyroid Cancer in the Marne and Ardennes Departments of France From 1975 to 2014

acronym: OTCancer

summary:
Introduction - Incidence of thyroid cancer has increased considerably in France in recent years, but the mortality rate has declined only slightly. Part of this increased incidence could be attributable to overdiagnosis. We aimed to estimate the contribution of overdiagnosis to the incidence of papillary thyroid cancer.

Material and methods. - Incidence rates were calculated based on data from the specialised Marnes-Ardennes thyroid cancer registry, for cancers diagnosed between 1975 and 2014, by age category and by five-year period. The population was divided into two groups according to pTNM classification at diagnosis (i.e. localised or invasive). Overdiagnosis was defined as the difference in incidence rates between the invasive cancer and localised cancer groups. This rate was then divided by the incidence rate in the localised cancer group for the most recent period (2010-2014) to obtain the proportion of cancers attributable to overdiagnosis.

ReferenceCitation: Saint-Martin C, Drame M, Dabakuyo S, Kanagaratnam L, Arveux P, Schvartz C. Overdiagnosis of thyroid cancer in the Marne and Ardennes Departments of France from 1975 to 2014. Ann Endocrinol (Paris). 2017 Feb;78(1):27-32. doi: 10.1016/j.ando.2016.07.005. Epub 2016 Sep 15.


title: Epidemiological Description of the Kaposi's Disease in France's Southeast

summary: The purpose of this study is to evaluate the prevalence of the Kaposi's disease in France's southeast on 10 years (from 2007 to 2017)

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Sainte-Anne


title: Portrayal of Hospital Alcohol Detoxifications and Factors Associated With Longer or Ulterior Hospitalizations in France From 2011 to 2020

acronym: Alcostop

summary: Even if hospital alcohol detoxifications are frequent in France, their caracteristicscharacteristics remain unknown. The investigators aim to describe the clinical and paraclinical caracteristicscharacteristics of their patients, their length and geographical repartition, etc… The investigators also aim to evaluate factors associated with longer stays or ulterior re-hospitalization for the same reason. Finally, The investigators aim to compare the stays by facility type.


title: Study of the Interest of ECG Teletransmission in Retirement Home (EHPAD) In the Ile-de-France Region.

acronym: TEECAD

summary: The aim of the study is to evaluate the interest and the workability of ECG teletranmission in EHPAD in Île-de-France. ECG for the elderly is beneficial to detect or monitor cardiovascular disease.

location_facility: Psychiatric Geriatric Department, Broca hospital


title: Study of Diabetes' Risk Factors and Accelerated Aging According to Socio-economic Status in a Population From the North of France

acronym: PREVENDIAB

summary:
Populations in precarious situations or with low socio-economic status have an increased risk of diabetes and accelerated aging. According to the population studied, the elements that can explain these health inequalities are not unequivocal and remain poorly known.

The north of France, particularly affected by socio-economic disparities, has a prevalence of diabetes among the highest in metropolitan France. This is why investigators want to study the clinical, biological, social and behavioural risk factors of the entry into diabetes and accelerated aging among a large population in the North of France.

This study aims to characterize the population (among which a majority (55%) suffers from precarious conditions) who come to carry out their health examination at the Pasteur Institute in Lille in order to study the risk factors to better explain these health inequalities.

This research consists of a main descriptive observational, cross-sectional study carried out on 2233 volunteers (main group) over 18 months, and a complementary analytical case-control study that will be offered to 216 participants (sub-group).

lead_sponsor: Institut Pasteur de Lille

collaborators: National Center for Precision Diabetic Medicine,PreciDIAB


title: Prevention of HIV in "Île-de-France"

acronym: ANRS-PREVENIR

summary:
Interventional HIV prevention strategy based on pre-exposure prophylaxis (PrEP) with Truvada® for people in the Île-de-France area (or Paris region) who don't have HIV but who are at high risk of becoming infected with HIV (men who have sex with men (MSM), transgender men and women, heterosexual men and women, sex workers, migrants) in combination with overall prevention services (communautary-based or educational counselling; addiction, social and psychological care; condoms and lubricating gel; clean injection equipment; sexually transmitted diseases (STD) screening and treatment; hepatitis A virus (HAV), hepatitis B virus (HBV) and hepatitis C virus (HCV) vaccinations and post-exposure treatment of HIV infection as soon as possible after diagnosis using an antiretroviral combination recommended by the French Guidelines on HIV treatment).

The individual benefit being already demonstrated in clinical trials, the aim is to demonstrate the public health impact of the interventional HIV prevention strategy by reducing the risk of getting HIV-1 infection of at least 15% of new diagnosis of HIV infections among MSM/transgender in the Ile-de-France area after a 3-year period.

primary_purpose: Prevention

ReferenceCitation: Molina JM, Ghosn J, Assoumou L, Delaugerre C, Algarte-Genin M, Pialoux G, Katlama C, Slama L, Liegeon G, Beniguel L, Ohayon M, Mouhim H, Goldwirt L, Spire B, Loze B, Surgers L, Pavie J, Lourenco J, Ben-Mechlia M, Le Mestre S, Rojas-Castro D, Costagliola D; ANRS PREVENIR Study Group. Daily and on-demand HIV pre-exposure prophylaxis with emtricitabine and tenofovir disoproxil (ANRS PREVENIR): a prospective observational cohort study. Lancet HIV. 2022 Aug;9(8):e554-e562. doi: 10.1016/S2352-3018(22)00133-3. Epub 2022 Jun 27.

publisher_dissemination: Elsevier

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility:
Hôpital Avicenne
Hôpital Antoine Béclère
Hôpital Européen Georges Pompidou
Hôpital Jean Verdier
Hôpital Raymond Poincaré
Centre Hospitalier Marc Jacquet
Hôpital Louis Mourier
Hôpital Bichat-Claude-Bernard
Hôpital Saint-Louis
Hôpital Hôtel Dieu
Hôpital Tenon
CHI Poissy Saint Germain en Laye
Hôpital Henry Mondor
Hôpital Cochin
Hôpital Necker-Enfants Malades
Hôpital Ambroise-Paré
Hôpital Pitié-Salpétrière
Hôpital Foch
Hôpital de Bicêtre
Hôpital André Mignot
Hôpital Saint-Antoine


title: Follow-up of Heart Failure Patients With an Implantable Cardiac Defibrillator Enabled With the HeartLogic Algorithm - HeartLogic France Study

summary:
Heart Failure (HF) is a chronic disease that leads to numerous rehospitalisations and affects more than one million people in France.

The main objective of this prospective multicentric French study is to describe the annual rate of unplanned hospitalisations for heart failure in a cohort of patients managed by a HeartLogic algorithm.

Patients will be included if they fulfill the following requirements 1/Patient implanted with a cardiac defibrillator with or without resynchronisation with the HeartLogic index (RESONATE family, Boston Scientific); 2/History of heart failure (left ventricular ejection fraction ≤40 %; or at least one episode of clinical heart failure with elevated NT pro BNP≥450 ng/L).

If a HeartLogic index ≥16 is noticed, the investigator will contact the patient to assess the patient's clinical condition and possibly adjust the heart failure treatment.

lead_sponsor: Poitiers University Hospital

location_facility:
University Hospital of Nantes
Clinique du Confluent
Hopital Europeen G Pompidou
University hospital of Grenoble
University Hospital of Tours
Hopital La Salpétrière
Hospital of Lorient
University hospital of Brest
Clinique Pasteur
University Hospital of Poitiers

intervention_type: Diagnostic Test


title: Hepatitis E Infection : Emergence Mechanisms in North-Eastern France of Polymorphic Clinical Forms.

acronym: VHENE

summary: The present research aims to collect virological and clinical data on hepatitis E virus (HEV) infections, either in acute or chronic forms of HEV infection in North-Eastern France, with liver- or non liver-related symptoms, plus data on HEV circulation in the outside environment. The purpose of this study is to improve the diagnosis and care of HEV-infected patients, as well as the preventive features to take into account in order to avoid food- and environment-borne infections. At last, we will investigate HEV molecular characteristics, with the hypothesis that some advantageous HEV strains coul be more pathogenic for some tissues and/or organs.


title: Evaluation of Covid-19 Vaccination in Elderly Subjects in Retirement Home (EHPAD) and Long-term Care Units (USLD) in Ile-de-France

acronym: COGEVAX

summary:
The main objective of this non-interventional, multi-center study is to compare the incidence of serious health events (death, unscheduled hospitalizations) in subjects vaccinated against Coronavirus with that of unvaccinated subjects, in Retirement Home (EHPAD) and Long-term Care Units (USLD) in Ile-De-France during the same observation period 12-months minimun and up to18 months according vaccinal schedule.

The primary outcome will be the incidence of serious health events (death and unscheduled hospitalizations) in subjects vaccinated against Coronavirus compared to that of unvaccinated subjects.


title: National Lymphangioleiomyomatosis Registry, France

acronym: RE-LAM-CE

summary:
RE-LAM-CE is a registry of lymphangioleiomyomatosis cases in France. its aim is to determine the incidence and prevalence of lymphangioleiomyomatosis in France, including demographic information and information concerning the timing and modalities of diagnosis.

Based on the registry, we will set up a prospective cohort of patients. The database will include detailed medical information, particularly regarding progression of the respiratory function.

lead_sponsor: Vincent COTTIN

sponsor_collaborators:
Vincent COTTIN
Hospices Civils de Lyon


title: Observational Study on the Use of Xydalba: A Multicenter, Prospective Study to Characterize the Use of Xydalba in France

summary:
This observational study will collect data on the use of the drug Xydalba® in daily clinical practice in France. Such observational studies are also referred to as registries. The sponsor of the study is Correvio International Sárl, based in Switzerland.

Xydalba® contains the active substance dalbavancin, a remedy for a certain type of bacterial pathogens (so-called "gram positive bacteria") which cause the disease. Active ingredients against bacteria are also called antibiotics.

Correvio wants to know which patients received the drug and how the disease went. The treatment places where you got Xydalba, ie clinic, intensive care unit or elsewhere should be recorded. In addition, it is important in this type of medication to track whether the pathogens are changing in any way. Any safety-relevant events (such as side effects) that have occurred during treatment should be investigated by the sponsor and submitted to the competent European authorities.

lead_sponsor: Correvio International Sarl

collaborators:
Universal Medical Group
PrimeVigilance

sponsor_collaborators:
Correvio International Sarl
Universal Medical Group
PrimeVigilance

location_facility: Centre Hospitalier de Tourcoing,Service des Maladies Infectieuses et du Voyageur

location_facility: CHU GRENOBLE, Maladies infectieuses et tropicales

location_facility: Centre hospitalier d'Ajaccio, Maladies infectieuses et tropicales

location_facility: Centre hospitalier régional et universitaire de Nancy

location_facility: Centre hospitalier universitaire de Nice

location_facility: Centre Hospitalier Universitaire de Nîmes (CHU)

location_facility: Pontchaillou University Hospital, Infectious Diseases and Intensive Care Unit

location_facility: Centre hospitalier universitaire de Saint-Étienne

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Saint-André

location_facility: Hôpital de la Croix-Rousse, Service des maladies infectieuses et tropicales


title: Puumala Hantavirus Infection in France: Evaluation of Commercial Assays for the Detection of Antibodies Against This Virus and the Use of Urine Samples for the Molecular Detection of This Infection

acronym: HANTADIAG

summary: Routine Puumala virus (PUUV) infection diagnosis is performed using serological commercial kits of which performances have not been established in real life, which use recombinant protein from strains from Central or North Europe. Molecular diagnostic of these infection is not the rule. Consequently the objectives of the project are to evaluate the performances of the serological commercial assays in real life in France and to assess the use of urine versus plasma for the molecular diagnostic of this infection.

ReferenceCitation: Plyusnin A, Horling J, Kanerva M, Mustonen J, Cheng Y, Partanen J, Vapalahti O, Kukkonen SK, Niemimaa J, Henttonen H, Niklasson B, Lundkvist A, Vaheri A. Puumala hantavirus genome in patients with nephropathia epidemica: correlation of PCR positivity with HLA haplotype and link to viral sequences in local rodents. J Clin Microbiol. 1997 May;35(5):1090-6. doi: 10.1128/jcm.35.5.1090-1096.1997.

ReferenceCitation: Prince HE, Lieberman JM. Impact of the Yosemite hantavirus outbreak on hantavirus antibody testing at a national reference laboratory. Clin Vaccine Immunol. 2013 Aug;20(8):1213-6. doi: 10.1128/CVI.00326-13. Epub 2013 Jun 5.

ReferenceCitation: Lederer S, Lattwein E, Hanke M, Sonnenberg K, Stoecker W, Lundkvist A, Vaheri A, Vapalahti O, Chan PK, Feldmann H, Dick D, Schmidt-Chanasit J, Padula P, Vial PA, Panculescu-Gatej R, Ceianu C, Heyman P, Avsic-Zupanc T, Niedrig M. Indirect immunofluorescence assay for the simultaneous detection of antibodies against clinically important old and new world hantaviruses. PLoS Negl Trop Dis. 2013 Apr 4;7(4):e2157. doi: 10.1371/journal.pntd.0002157. Print 2013. Erratum In: PLoS Negl Trop Dis. 2020 Nov 9;14(11):e0008864.

ReferenceCitation: Hentzien M, Mestrallet S, Halin P, Pannet LA, Lebrun D, Drame M, Bani-Sadr F, Galempoix JM, Strady C, Reynes JM, Penalba C, Servettaz A. Bioclinical Test to Predict Nephropathia Epidemica Severity at Hospital Admission. Emerg Infect Dis. 2018 Jun;24(6):1045-1054. doi: 10.3201/eid2406.172160.

ReferenceType: result

ReferenceCitation: Reynes JM, Schaeffer L, Papadopoulos P, Ait-Ahmed M, Siby-Diakite D, Ripaux-Lefevre M, Buivan TP, Lechat S, Vray M, Galempoix JM; HANTADIAG Study Group. Molecular Detection of Orthohantavirus puumalaense in Plasma and Urine Samples from Hospitalized Patients Presenting with a Serologically Confirmed Acute Hantavirus Infection in France. J Clin Microbiol. 2023 Aug 23;61(8):e0037223. doi: 10.1128/jcm.00372-23. Epub 2023 Jul 24.

publisher_dissemination: American Society for Microbiology

lead_sponsor: Centre Hospitalier de Charleville-Mézières

location_facility:
CH Belfort-Montbéliard
CHU Reims
CH de Laon
CH de Saint Claude
CH Charleville Mézières
CHU Besançon
CH de Verdun
CHU Dijon
CHP Sud de l'Oise
CHU Nancy

appel_a_projets: PHRCN

region: Grand Est

nom_etablissement: CHI NORD ARDENNES

type_etablissement: CH

acronyme: HANTADIAG

titre: Infection par l'hantavirus Puumala en France : évaluation de trousses de diagnostic sérologique et de l'emploi d'un prélèvement d'urine pour le diagnostic moléculaire de cette hantavirose

discipline_principale: biologie

nom_porteur: PENALBA

prenom_porteur: Christian


title: Multicenter, Non-interventional Study, Describing Patients With Inherited Retinal Disease (IRD) in France

acronym: EPI-genRET

summary:
Genetic diagnostic testing becomes increasingly important for enhancing our understanding of the disease notably the genetics and providing the best care to the patients, and several initiatives seek to gather more data in order to better understand and treat those diseases.

Within this context, Novartis and SENSGENE/Strasbourg University Hospitals (HUS) want to set up, through a research collaboration, a non-interventional study in France to better understand the epidemiology of IRDs, particularly the distribution of pathogenic variants in patients. This study aims to serve as a starter study to implement an IRD national registry led by SENSGENE/Strasbourg University Hospitals (HUS). The data collected might also be used to populate global European registries. The primary objective has been defined in a sufficient broad way to address this perspective of registries.

As IRDs can present from birth to late middle age, this study will include both children and adult patients regardless of age, sex, and the type of IRD.

lead_sponsor: University Hospital, Strasbourg, France


title: Cutaneous Diphtheria in France : an Observational, Retrospective Study of Epidemiological, Clinical, Microbiological and Therapeutic Characteristics

acronym: OEDIPE

summary: Toxigenic cutaneous diphtheria is a notifiable disease that is re-emerging in the world and particularly in France. A better description of the epidemiological characteristics, as well as a refinement of the clinical characteristics of patients with cutaneous diphtheria, are essential to better understand this pathology, which has important public health issues and whose diagnosis absence can have catastrophic consequences for the patient and their contacts. Microbiological data (species identification, toxigenicity or not, resistance profile...) will be transmitted by the national reference center for corynebacteria of the diphtheriae complex and then caregivers who have managed the corresponding patients with cutaneous diphtheria will be contacted.

ReferenceCitation: Bernard KA, Pacheco AL, Burdz T, Wiebe D. Increase in detection of Corynebacterium diphtheriae in Canada: 2006-2019. Can Commun Dis Rep. 2019 Nov 7;45(11):296-301. doi: 10.14745/ccdr.v45i11a04. eCollection 2019 Nov 7.

ReferenceCitation: Martini H, Soetens O, Litt D, Fry NK, Detemmerman L, Wybo I, Desombere I, Efstratiou A, Pierard D. Diphtheria in Belgium: 2010-2017. J Med Microbiol. 2019 Oct;68(10):1517-1525. doi: 10.1099/jmm.0.001039.

ReferenceCitation: Jaton L, Kritikos A, Bodenmann P, Greub G, Merz L. [European migrant crisis and reemergence of infections in Switzerland]. Rev Med Suisse. 2016 Apr 13;12(514):749-53. French.

ReferenceCitation: Morgado-Carrasco D, Riquelme-Mc Loughlin C, Fusta-Novell X, Fernandez-Pittol MJ, Bosch J, Mascaro JM Jr. Cutaneous Diphtheria Mimicking Pyoderma Gangrenosum. JAMA Dermatol. 2018 Feb 1;154(2):227-228. doi: 10.1001/jamadermatol.2017.4786. No abstract available.

ReferenceCitation: Pandit N, Yeshwanth M. Cutaneous diphtheria in a child. Int J Dermatol. 1999 Apr;38(4):298-9. doi: 10.1046/j.1365-4362.1999.00658.x. No abstract available.

ReferenceCitation: Wagner KS, White JM, Lucenko I, Mercer D, Crowcroft NS, Neal S, Efstratiou A; Diphtheria Surveillance Network. Diphtheria in the postepidemic period, Europe, 2000-2009. Emerg Infect Dis. 2012 Feb;18(2):217-25. doi: 10.3201/eid1802.110987.

ReferenceCitation: Gower CM, Scobie A, Fry NK, Litt DJ, Cameron JC, Chand MA, Brown CS, Collins S, White JM, Ramsay ME, Amirthalingam G. The changing epidemiology of diphtheria in the United Kingdom, 2009 to 2017. Euro Surveill. 2020 Mar;25(11):1900462. doi: 10.2807/1560-7917.ES.2020.25.11.1900462.

ReferenceCitation: Koopman JS, Campbell J. The role of cutaneous diphtheria infections in a diphtheria epidemic. J Infect Dis. 1975 Mar;131(3):239-44. doi: 10.1093/infdis/131.3.239.

ReferenceCitation: de Benoist AC, White JM, Efstratiou A, Kelly C, Mann G, Nazareth B, Irish CJ, Kumar D, Crowcroft NS. Imported cutaneous diphtheria, United Kingdom. Emerg Infect Dis. 2004 Mar;10(3):511-3. doi: 10.3201/eid1003.030524.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

collaborators: Centre d'Epidémiologie et de Santé Publique des Armées

location_facility: Groupement Hospitalier Diaconesses Croix Saint Simon

location_facility: Institut Hospitalo-Universitaire de Marseille

location_facility: Centre Hospitalier Départemental de Vendée


title: Impact of Containment and Quarantine During COVID-19 Outbreack on Psychotic Symptoms in the General Population in France

summary: Study the impact of containment related to COVID-19 pandemic on psychotic experiences in the general population in France.

collaborators: Epsylon Laboratory, EA 4556, University Paul Valéry Montpellier 3, France

collaborators: Laboratoy LIP/PC2S, University Grenobles-Alpes, Grenoble, France

collaborators: Centre référent de réhabilitation psychosociale de Grenoble, Grenoble, France


title: Study of Acute Autoimmune Encephalitis With Positive Antibodies in Eastern France Between 2006 and 2018

acronym: Encephalitis

summary:
The number of acute encephalitides diagnosed each year is gradually increasing, reaching approximately 5 to 10/100,000 per year; more than 50% of etiologies currently remain unknown. The majority of them are acute encephalitis of infectious origin, but it is estimated that 20% of encephalitis in northern Europe is related to an autoimmune mechanism with the majority of encephalitis with anti-NMDA Ac discovered recently in 2007. The study of a large American encephalitis cohort showed a death rate of 3% to 7% in cases of autoimmune encephalitis. Furthermore, delay in the initiation of effective treatment (tumor removal or immunotherapy) beyond 4 weeks is associated with a poor prognosis at 1 year.

It is therefore necessary to better understand the signs of autoimmune encephalitis in order to recognize the disease quickly and to start a treatment quickly; in order to improve the management and the prognosis of these children.

location_facility: Service de Pédiatrie 1 - CHU de Strasbourg - France


summary: The aim is to document viral etiologies of isolated fevers and inlfuenza-like syndromes during summertime in South of France in order to better understand the role of known vector-borne viruses such as Toscana virus, West Nile virus during seasonal activity of the arthropod vector. In each of the four cities, a network of general practitioners will be associated in the project to recruit patients who are not hospitalized. The combined involvement of infectious disease specialists and general practitioner will augment the range of patients (mild disease and sever cases) in the study.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Service des Maladies Infectieuses et Tropicales de l'Hôpital Nord, AP-HM


title: Registry of Congenital Anomalies in Nouvelle-Aquitaine, France

acronym: ATENA

summary: Regional population-based registry for the epidemiological surveillance of congenital anomalies

lead_sponsor: University Hospital, Bordeaux

collaborators: Institut de Recherche en Santé Publique, France


title: Feasibility of a Newborn Screening for Spinal Muscular Atrophy (SMA) in France: DEPISMA Prefigurator Project in Grand Est and Nouvelle Aquitaine

acronym: DEPISMA

summary:
Spinal muscular atrophy (SMA) is a genetic disease of the nervous system that affects about 1 in 7,0001.2 births and results in very high mortality for patients with the disease. There are about 120 new cases in France each year and an estimated total of 2500 patients. It is the leading cause of genetic mortality in children in France. Until 2017, no etiological treatment was available. Currently, three treatments have been approved and have authorizations in France. The current clinical developments in SMA show the importance of an early treatment for patients. 3. The identification of pre-symptomatic patients is therefore essential to improve the effectiveness of treatments on an individual level and to avoid any loss of chance, as well as to reduce the societal cost of disability for patients treated in post-symptomatic. Several countries in Europe and around the world have implemented regional pilot screening programs for the disease. The screening test is based on a molecular genetic analysis that has been performed for many years, and which is highly reliable; there is currently no biochemical marker that can be used.

The objective of our project is to demonstrate the feasibility of neonatal screening for spinal amyotrophy in two French regions before being able to propose to extend it to the whole of France. The management of all screened patients will be decided outside the pilot study, by the existing national multidisciplinary consultation meeting, according to the best available standards of care and will be based on the national network of neuromuscular disease reference centers The objective of the project is not the evaluation of the efficacy of treatments or neonatal screening: these objectives are being studied by existing or otherwise ongoing studies around the world.

This project has been set up to be in line with the existing structures in France that are responsible for neonatal screening (via the regional neonatal screening centers (CRDN) and the regional perinatal networks) and for the management of rare diseases (via the neuromuscular disease reference centers and their FILNEMUS network). This project is performed in collaboration with AFM Telethon, Directorate of Health Care Supply, Regional Health Agency (ARS), FILNEMUS network, Novartis Gene Therapies, Roche Pharma AG,Biogen.

Investigator wish, as far as possible, to bring this study closer to real life and to be able to generate as much information as possible that can be used directly to prefigure the potential generalization of this screening strategy to the entire national territory.

location_facility: Ch de Verdun St Mihiel Hôpitalst Nicolas

location_facility: Hôpital Albert Schweitzer - Clinique Du Diaconat de Colmar


title: Impact of HPV Vaccination on the Distribution of HPV in High Grade Lesions of the Cervix in France

acronym: IMPACT

summary: The objective is to estimate the prevalence of the different genotypes of human papillomaviruses (HPV) in histologically proven high-grade lesions of the cervix in patients born between 1972 and 1993. It is plan to determine if the prevalence of HPV16 and HPV18 is lower in the population born between 1983 and 1993 and potentially exposed to HPV vaccination compared to those born between 1972 and 1982 who were not exposed to vaccination. Thus the investigators should be able to determine whether the introduction of HPV vaccination in France in 2007 has had an impact on the development of high-grade lesions associated with HPV16 and HPV18.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Real-life Study of the Characteristics of Patients Treated With Ilaris® (Canakinumab) for Gouty Arthritis in France

summary:
This was a non-interventional, retrospective, cross-sectional, descriptive study, conducted on the National Health Data System (Système National des Données de Santé, SNDS).

The study did not modify the doctor-patient relationship, nor the management or follow-up of patients. Patients with dispensation of canakinumab for gouty arthritis were selected over the period from 08 April 2018 to 07 April 2020; index date was defined as date of the first dispensation of canakinumab in community pharmacy during study period.

Patients were described at index date. Medical history and comorbidities, and previous treatments for gouty arthritis were assessed during 3 years prior to index date. Co-treatments of interest for which standard treatments for gouty arthritis were contraindicated or required precautions for use were assessed during 6 months prior to index date.

lead_sponsor: Novartis Pharmaceuticals


title: France PCI Registry : National Observatory of Interventional Cardiology

summary:
Rigorous clinical practice assessment is a key factor to improve patient's care and prognosis in interventional cardiology (IC). A multicentric IC observational study (CRAC), fully integrated to usual coronary activity report software, started in Centre Val de Loire (CVL) region in 2014.

CRAC observatory was conduced on five IC CathLab of CVL region. Quality of collected data is regularly evaluated and allowed building an exhaustive, and reliable database. This solution could easily be developed in other French regions.

lead_sponsor: Club Régional des Angioplasticiens de la région Centre

collaborators:
Agence Régional de Santé du Centre
Direction Générale de l'Offre de Soins
France PCI Association

location_facility: CHU Gabriel-Montpied de Clermont-Ferrand

location_facility: Centre Hospitalier Jacques Coeur de Bourges

location_facility: Research Cardiology Unit / Les hopitaux de Chartres

location_facility: Groupe Hospitalier du Havre - Hôpital Jacques Monod

location_facility: Pôle Santé Oréliance - Clinique de la Reine Blanche

location_facility: Centre Hospitalier Henri Mondor d'Aurillac


title: A Multi-centre, Prospective, Noninterventional Study Investigating the Effectiveness of Once-weekly Subcutaneous Semaglutide in a Real World Adult Population With Type 2 Diabetes

acronym: SURE FRANCE

summary: The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by their study doctor. The study will last for about 6 to 8 months. The participants will be asked to complete some questionnaires about their health and their diabetes treatment. Participants will complete these during their normally scheduled visits with their study doctor.

ReferenceCitation: Mohammedi K, Belhatem N, Berentzen TL, Catarig AM, Potier L. Once-weekly semaglutide use in patients with type 2 diabetes: Results from the SURE France multicentre, prospective, observational study. Diabetes Obes Metab. 2023 Jul;25(7):1855-1864. doi: 10.1111/dom.15045. Epub 2023 Mar 28.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S


title: HCV Care Pathway in Ile-de-France

acronym: ParcoursVHC

summary: The main objective of this research is to evaluate a care pathway adapted to different category populations at risk of being infected with the hepatitis C virus in order to improve both the diagnosis turnaround times and the access to treatment. The aim is to allow a quick and effective access to diagnosis and treatment of HCV by strengthening the city hospital networks, access to early consultations and coordination of medical social actors.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: Agence Regionale de Sante d'Ile de France


title: Myocardial Infarction Rates Overview During COVID-19 Pandemic In France: MODIF Study

acronym: MODIF

summary: In late December 2019, an emerging disease due to a novel coronavirus (named SARS-CoV-2) rapidly spread in China and outside. France is currently facing the COVID-19 wave with more than 131 863 confirmed cases and almost 25 201 deaths. Systems of care have been reorganized in an effort to preserve hospital bed capacity, resources, and avoid exposure of patients to the hospital environment where COVID-19 may be more prevalent. Therefore, elective procedures of catheterization and programmed hospitalizations have been delayed. However, a significant proportion of procedures within the catheterization laboratory such as ST-elevation myocardial infarction (STEMI), non ST elevation myocardial infarction or unstable angina are mandatory and cannot be postponed. Surprisingly, invasive cardiologist noticed a drop in STEMI volume without reliable data to confirm this impression. Furthermore, a recent single center report in Hong Kong pointed out longer delays of taking care when compared to patients with STEMI treated with percutaneous intervention the previous year. These data are at major concern because delay in seeking care or not seeking care could have detrimental impact on outcomes.

lead_sponsor: French Cardiology Society


title: Gastroprotective Agent Utilization and Compliance in Elderly Patients Taking Non-steroidal Anti-inflammatory Drug (NSAID) in France

summary: The purpose of this study is to assess in general population NSAID and gastroprotective agent utilization and compliance in elderly people.

lead_sponsor: AstraZeneca


title: BIO|STREAM.ICM France, Submodule of the BIO|STREAM.ICM Registry

summary: The main objective of the BIO│STREAM.ICM France submodule is to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR system

lead_sponsor: Biotronik SE & Co. KG

location_facility:
CHRU de Tours, Hopital Trousseau
Hôpital Gabriel Montpied
CH Villefranche Sur Saone


title: Long Term Follow up of Patients Under 5 Years of Age With High Grade Glioma Diagnosed in France Between 1990 and 2015

summary: High grade glioma is a rare disorder affecting children at all ages with a high mortality rate. Overall survival is estimated at 40%, depending on the type of treatment administered. Major late sequelaes are experienced with the irradiation in this population under 5 years. Therefore, the current recommendations by The French Society for Childhood Cancers are based on a treatment including surgery followed by chemotherapy and avoiding radiotherapy as long as patients present no sign of treatment failure. The results published in 2006, underlying the fact that some patients treated exclusively with surgical resection and chemotherapy can achieve long term survival, are showing evidence of an acceptable long-term strategy. Few studies concerning evaluation of treatment toxicity and long term outcomes are available. Therefore, it is important to collect retrospective data concerning those small patients with high grade glioma in order to understand the reasons of treatment success or failure and treatment toxicities. This retrospective study will evaluate long term survivals comparatively to clinical, radiological and histological features at diagnosis and the treatment toxicities including neurological, endocrine and hearing impairment to go further and propose new potential guidelines and chemotherapy schedules


title: Connection Between GP's Estimation of Cardiovascular Risk and Theoretical Calculation in France

summary: The purpose of this study is to evaluate connection between GP's estimation of cardiovascular risk and theoretical calculation.


title: Evaluation of Vitamin D Deficiency Distribution in Children With Sickle Cell Disease Followed in Lyon, France

acronym: EVADDREP

summary: Vitamin D deficiency may be under-diagnosed in sickle cell disease French children. Therefore, the investigator need an epidemiologic study about the prevalence of vitamin D deficiency in this specific population. There are not specific guidelines neither testing nor treatment. The investigator propose to test vitamin D status in all children with sickle cell disease who are consulting their referring haematologist doctor or in the emergency ward.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Femme Mère enfant - Urgences pédiatriques

intervention_type: Biological


title: Use of Methylphenidate in Children and Adolescents in France

summary: The use of methylphenidate in children and adolescents in France from 2010 to 2015


title: Observational Study of the Use of the Service Giving Access to Teleconsultation in France by Telemedicine Companies

acronym: TELET

summary:
Teleconsultation is a telemedicine medical act carried out remotely via information and communication technologies. This medical procedure has been legal in France since 2010 and reimbursed by the National Health Insurance under certain conditions since 2018. In 2020, following the COVID-19 epidemic, the lockdowns and the extension of the scope of financial coverage, 17 million teleconsultations have been reimbursed.

To date, few scientific studies have been published in France to precisely describe the use of the service giving access to outpatient teleconsultation, in particular since the major increase in activity linked to the COVID-19 epidemic.

The objective is to describe the use of the service giving access to outpatient teleconsultation carried out in France by teleconsultation companies and compare the use of the teleconsultation service according to the medical density of the territory.

lead_sponsor: Les Entreprises de Télémédecine


title: Outpatient Use of Analgesics in Children and Adolescents in France

summary: outpatient use of analgesics in children and adolescents in France from 2012 to 2015


title: C.O.R.P.U.S. : Observational Cohort of Active Rheumatoid Arthritis, Spondylarthropathy and Idiopathic Juvenile Arthritis in France

summary:
C.O.R.P.U.S. is the first French observatory of care practices in active inflammatory rheumatism of children and adults: rheumatoid arthritis, spondylarthropathy, and idiopathic juvenile arthritis, established under the auspices of national health authorities.

Its goal is to document safety, effectiveness in routine practice of various therapy, including biotherapy, of prescription or non-prescription over 5 years.

A cohort will be constituted including any new case of active disease (DAS 28 > 3,2, BASDAI > 4, failure of methotrexate), without previous prescription of biotherapy. Therefore, it will be possible to have patients non exposed to biotherapy (non indication, refusal, contraindication) compared to patients exposed to biotherapy, and to monitor adverse events occurrence as well as effectiveness in routine practice over time, according to prescription, maintenance or switch of various therapies.

ipd_sharing_description: open to partnership

lead_sponsor: Central Hospital, Nancy, France


title: Living Conditions After Non-Hodgkin's Lymphoma in France

acronym: LymphoVie 2

summary:
This is an innovative project, allowing to study for the first time the long-term living conditions of patients after diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) from population data in France. Patients will be selected from the three specialized hematology registries in France: Côte-d'Or, Gironde and Basse-Normandie.

This is also one of the first studies to look at epidemiological indicators of net survival after diagnosis of follicular lymphoma and diffuse large B-cell lymphoma, adjusted for clinical factors such as disease stage, therapeutic management, and comorbidities, apart from the standard adjustment factors of age, sex, and time of diagnosis in real life. In addition, the proportion of cured patients will be estimated.

For component 1, this will be the survival analysis on the initial data. For part 2, questionnaires will be sent out followed by a follow-up if necessary one month after the mailing. There is no physical interview nor any specific biological or imaging examination.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Intensive Care Unit Activity in France From the National Database Between 2013 and 2019: More Critically Ill Patients, Shorter Stay and Lower Mortality Rate

summary:
Using data from the French National Uniform Hospital Discharge Database (systematically collecting administrative and medical information related to all hospitalized patients in France for care reimbursement purposes), the present study retrospectively assesses the activity of the French Intensive Care Unit (ICU)(1,594,801 ICU admissions):

In-ICU and in-hospital mortality rates
Length of stay in ICU and hospital
Mortality-associated factors during the study period.
Number of organ failures
Bed occupancy,
Regional variations in previous indicators

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France: the FEERIC Study

acronym: FEERIC

summary: FErtility, PrEgnancy, contRaceptIon after breast Cancer in France

lead_sponsor: Institut Curie

sponsor_collaborators:
Institut Curie
seintinelles network


title: Gynaecological Follow-up of Women With Down Syndrom Aged 18 to 30 in France

summary:
Gynaecological check-ups for women are recommended in France. However, some groups of the population are affected by a lack or absence of medical surveillance.

In France, there are one million people with an intellectual disability, including 50,000 with Down syndrome.

Although this disability causes numerous physical and psychological deficits, no gynaecological consequences have yet been demonstrated.

Regular gynaecological check-ups are therefore necessary, according to French recommendations.

However, several studies have shown that women with mental illness receive less or no gynaecological care.

lead_sponsor: Université de Reims Champagne-Ardenne


type: Other Grant/Funding Number

title: Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy (France)

summary: An unblinded, randomized, cross-over design with each patient participating in two 40-hour outpatient admissions: (a) Experimental involving automated Control-to-Range (CTR) and (b) Control using Continuous Glucose Monitor (CGM)-augmented insulin pump treatment outside of a hospital based clinical research center.

primary_purpose: Treatment

ReferenceCitation: Kovatchev BP, Renard E, Cobelli C, Zisser HC, Keith-Hynes P, Anderson SM, Brown SA, Chernavvsky DR, Breton MD, Mize LB, Farret A, Place J, Bruttomesso D, Del Favero S, Boscari F, Galasso S, Avogaro A, Magni L, Di Palma F, Toffanin C, Messori M, Dassau E, Doyle FJ 3rd. Safety of outpatient closed-loop control: first randomized crossover trials of a wearable artificial pancreas. Diabetes Care. 2014 Jul;37(7):1789-96. doi: 10.2337/dc13-2076. Epub 2014 Jun 14.

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: American Diabetes Association

lead_sponsor: University of Virginia

sponsor_collaborators:
University of Virginia
Juvenile Diabetes Research Foundation
University of Padova
University of California, Santa Barbara

location_facility: Centre d'Investigation Clinique CHU Montipellier

intervention_type: Device


title: Prospective, Multicentric Observational Study Evaluating the Management of Chronic Coronary Occlusions In France

acronym: ENCOCHE

summary:
Data from the literature on the management of Chronic Coronary Occlusions (CTO) in France highlight a lack of epidemiological data on these patients at the national level.

For this reason, it was decided to set up this large-scale survey in order to have a picture of the management of patients with chronic coronary occlusion in France, to study the prevalence of CTOs in France as well as their management (medical, surgical or interventional), and then by analysing more precisely, over a second survey period, CTO angioplasties in terms of success rates, complications, medico-economic impact.

ReferenceCitation: Di Mario C, Werner GS, Sianos G, Galassi AR, Buttner J, Dudek D, Chevalier B, Lefevre T, Schofer J, Koolen J, Sievert H, Reimers B, Fajadet J, Colombo A, Gershlick A, Serruys PW, Reifart N. European perspective in the recanalisation of Chronic Total Occlusions (CTO): consensus document from the EuroCTO Club. EuroIntervention. 2007 May;3(1):30-43. No abstract available.

ReferenceCitation: Kahn JK. Angiographic suitability for catheter revascularization of total coronary occlusions in patients from a community hospital setting. Am Heart J. 1993 Sep;126(3 Pt 1):561-4. doi: 10.1016/0002-8703(93)90404-w.

ReferenceCitation: Werner GS, Gitt AK, Zeymer U, Juenger C, Towae F, Wienbergen H, Senges J. Chronic total coronary occlusions in patients with stable angina pectoris: impact on therapy and outcome in present day clinical practice. Clin Res Cardiol. 2009 Jul;98(7):435-41. doi: 10.1007/s00392-009-0013-5. Epub 2009 Mar 18.

ReferenceCitation: Fefer P, Knudtson ML, Cheema AN, Galbraith PD, Osherov AB, Yalonetsky S, Gannot S, Samuel M, Weisbrod M, Bierstone D, Sparkes JD, Wright GA, Strauss BH. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am Coll Cardiol. 2012 Mar 13;59(11):991-7. doi: 10.1016/j.jacc.2011.12.007.

ReferenceCitation: Garcia S, Sandoval Y, Roukoz H, Adabag S, Canoniero M, Yannopoulos D, Brilakis ES. Outcomes after complete versus incomplete revascularization of patients with multivessel coronary artery disease: a meta-analysis of 89,883 patients enrolled in randomized clinical trials and observational studies. J Am Coll Cardiol. 2013 Oct 15;62(16):1421-31. doi: 10.1016/j.jacc.2013.05.033. Epub 2013 Jun 7.

ReferenceCitation: Sachdeva R. Effect of revascularization of chronic total occlusion on tandem stenoses in a "donor" artery. Tex Heart Inst J. 2014 Oct 1;41(5):547-50. doi: 10.14503/THIJ-13-3569. eCollection 2014 Oct.

ReferenceCitation: Stone GW, Reifart NJ, Moussa I, Hoye A, Cox DA, Colombo A, Baim DS, Teirstein PS, Strauss BH, Selmon M, Mintz GS, Katoh O, Mitsudo K, Suzuki T, Tamai H, Grube E, Cannon LA, Kandzari DE, Reisman M, Schwartz RS, Bailey S, Dangas G, Mehran R, Abizaid A, Moses JW, Leon MB, Serruys PW. Percutaneous recanalization of chronically occluded coronary arteries: a consensus document: part II. Circulation. 2005 Oct 18;112(16):2530-7. doi: 10.1161/CIRCULATIONAHA.105.583716. No abstract available.

ReferenceCitation: Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18. Erratum In: N Engl J Med. 2013 Feb 7;368(6):584.

ReferenceCitation: Olivari Z, Rubartelli P, Piscione F, Ettori F, Fontanelli A, Salemme L, Giachero C, Di Mario C, Gabrielli G, Spedicato L, Bedogni F; TOAST-GISE Investigators. Immediate results and one-year clinical outcome after percutaneous coronary interventions in chronic total occlusions: data from a multicenter, prospective, observational study (TOAST-GISE). J Am Coll Cardiol. 2003 May 21;41(10):1672-8. doi: 10.1016/s0735-1097(03)00312-7.

ReferenceCitation: Srivatsa SS, Edwards WD, Boos CM, Grill DE, Sangiorgi GM, Garratt KN, Schwartz RS, Holmes DR Jr. Histologic correlates of angiographic chronic total coronary artery occlusions: influence of occlusion duration on neovascular channel patterns and intimal plaque composition. J Am Coll Cardiol. 1997 Apr;29(5):955-63. doi: 10.1016/s0735-1097(97)00035-1.

ReferenceCitation: Katsuragawa M, Fujiwara H, Miyamae M, Sasayama S. Histologic studies in percutaneous transluminal coronary angioplasty for chronic total occlusion: comparison of tapering and abrupt types of occlusion and short and long occluded segments. J Am Coll Cardiol. 1993 Mar 1;21(3):604-11. doi: 10.1016/0735-1097(93)90091-e.

ReferenceCitation: Rathore S, Matsuo H, Terashima M, Kinoshita Y, Kimura M, Tsuchikane E, Nasu K, Ehara M, Asakura Y, Katoh O, Suzuki T. Procedural and in-hospital outcomes after percutaneous coronary intervention for chronic total occlusions of coronary arteries 2002 to 2008: impact of novel guidewire techniques. JACC Cardiovasc Interv. 2009 Jun;2(6):489-97. doi: 10.1016/j.jcin.2009.04.008.

ReferenceCitation: de Labriolle A, Bonello L, Roy P, Lemesle G, Steinberg DH, Xue Z, Kaneshige K, Suddath WO, Satler LF, Kent KM, Pichard AD, Lindsay J, Waksman R. Comparison of safety, efficacy, and outcome of successful versus unsuccessful percutaneous coronary intervention in "true" chronic total occlusions. Am J Cardiol. 2008 Nov 1;102(9):1175-81. doi: 10.1016/j.amjcard.2008.06.059. Epub 2008 Aug 27.

ReferenceCitation: Suero JA, Marso SP, Jones PG, Laster SB, Huber KC, Giorgi LV, Johnson WL, Rutherford BD. Procedural outcomes and long-term survival among patients undergoing percutaneous coronary intervention of a chronic total occlusion in native coronary arteries: a 20-year experience. J Am Coll Cardiol. 2001 Aug;38(2):409-14. doi: 10.1016/s0735-1097(01)01349-3.

ReferenceCitation: Hoye A, van Domburg RT, Sonnenschein K, Serruys PW. Percutaneous coronary intervention for chronic total occlusions: the Thoraxcenter experience 1992-2002. Eur Heart J. 2005 Dec;26(24):2630-6. doi: 10.1093/eurheartj/ehi498. Epub 2005 Sep 23.

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title: Fabry Disease Prevalence in End-stage Renal Disease (ESRD) Patients on Dialysis or Transplant in West of France

acronym: SNOUFY

summary: Screening of Fabry disease in end-stage renal disease (ESRD) patients on dialysis or transplant in west of France.

lead_sponsor: Rennes University Hospital