title: Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Data Platform: Evolution of the Therapeutic Care in Lung Cancer in France Since 2015

summary: The ESME LC Data Platform is a multicenter real life database using a retrospective data collection process in France over 38 sites. This database compiles data from Patient's Electronic medical records (EMR), inpatient Hospitalisation records and Pharmacy records.

ReferenceCitation: Robain M, Pérol M, Girard N, Debieuvre D, Coudert B, Madroszyk A, et al. Programme épidémio-stratégie médicoéconomique : une base nationale de données de vie réelle pour mieux comprendre la prise en charge du cancer bronchopulmonaire en France. Revue des Maladies Respiratoires. 2018 Jan;35:A106.

ReferenceType: result

ReferenceCitation: Girard, N., M. Pérol, G. Simon, C. Audigier Valette, R. Gervais, D. Debieuvre, R. Schott, et al. " 90P - Real-world treatment patterns, clinical practice and outcomes for locally advanced, non resectable, non-small cell lung cancer from the French ESME Lung database ". Abstract Book of the European Lung Cancer Congress (ELCC) 10-13 April 2019, Geneva, Switzerland 30 (1 avril 2019): ii34. https://doi.org/10.1093/annonc/mdz067.006.

ReferenceCitation: Chouaid C, Filleron T, Debieuvre D, Perol M, Girard N, Dansin E, Lena H, Gervais R, Cousin S, Otto J, Schott R, Planchard D, Madroszyk A, Kaderbhai C, Dubray-Longeras P, Hiret S, Pichon E, Clement-Duchene C, Chenuc G, Simon G, Bosquet L, QUantin X. A Real-World Study of Patients with Advanced Non-squamous Non-small Cell Lung Cancer with EGFR Exon 20 Insertion: Clinical Characteristics and Outcomes. Target Oncol. 2021 Nov;16(6):801-811. doi: 10.1007/s11523-021-00848-9. Epub 2021 Oct 18.

ReferenceCitation: Lamy T, Cabarrou B, Planchard D, Quantin X, Schneider S, Bringuier M, Besse B, Girard N, Chouaid C, Filleron T, Simon G, Baldini C. Biomarker Testing in Older Patients Treated for an Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer: The French ESME Real-Life Multicenter Cohort Experience. Cancers (Basel). 2021 Dec 24;14(1):92. doi: 10.3390/cancers14010092.

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

ReferenceCitation: Griesinger F, Perol M, Girard N, Durand-Zaleski I, Zacharias S, Bosquet L, Janicke M, Quantin X, Groth A, Fleitz A, Calleja A, Patel S, Lacoin L, Daumont MJ, Penrod JR, Carroll R, Waldenberger D, Reynaud D, Thomas M, Chouaid C. Impact of immune checkpoint inhibitors on the management of locally advanced or metastatic non-small cell lung cancer in real-life practice in patients initiating treatment between 2015 and 2018 in France and Germany. Lung Cancer. 2022 Oct;172:65-74. doi: 10.1016/j.lungcan.2022.08.001. Epub 2022 Aug 6.

ReferenceCitation: Chouaid C, Thomas M, Debieuvre D, Durand-Zaleski I, Zacharias S, Bosquet L, Groth A, Fleitz A, Calleja A, Patel S, Lacoin L, Daumont MJ, Penrod JR, Carroll R, Waldenberger D, Cotte FE, Audigier-Valette C, Griesinger F. Effectiveness of Nivolumab in Second-Line and Later in Patients with Advanced Non-Small Cell Lung Cancer in Real-Life Practice in France and Germany: Analysis of the ESME-AMLC and CRISP Cohorts. Cancers (Basel). 2022 Dec 13;14(24):6148. doi: 10.3390/cancers14246148.

repository_institution: Conservatoire national des arts et métiers - HAL CNAM

ReferenceCitation: Bringuier M, Carton M, Debieuvre D, Pasquier D, Perol M, Filleron T, Lena H, Quantin X, Simon G, Baldini C. Enrolment of older adults with advanced or metastatic non-small cell lung cancer in first-line clinical trials in the multicentre ESME cohort. J Geriatr Oncol. 2023 Mar;14(2):101423. doi: 10.1016/j.jgo.2022.101423. Epub 2023 Jan 17.

ReferenceCitation: Chouaid C, Bosquet L, Girard N, Kron A, Scheffler M, Griesinger F, Sebastian M, Trigo J, Viteri S, Knott C, Rodrigues B, Rahhali N, Cabrieto J, Diels J, Perualila NJ, Schioppa CA, Sermon J, Toueg R, Erdmann N, Mielke J, Nematian-Samani M, Martin-Fernandez C, Pfaira I, Li T, Mahadevia P, Wolf J. An Adjusted Treatment Comparison Comparing Amivantamab Versus Real-World Clinical Practice in Europe and the United States for Patients with Advanced Non-Small Cell Lung Cancer with Activating Epidermal Growth Factor Receptor Exon 20 Insertion Mutations. Adv Ther. 2023 Mar;40(3):1187-1203. doi: 10.1007/s12325-022-02408-7. Epub 2023 Jan 18.

ReferenceCitation: Belaroussi Y, Bouteiller F, Bellera C, Pasquier D, Perol M, Debieuvre D, Filleron T, Girard N, Schott R, Mathoulin-Pelissier S, Martin AL, Cousin S. Survival outcomes of patients with metastatic non-small cell lung cancer receiving chemotherapy or immunotherapy as first-line in a real-life setting. Sci Rep. 2023 Jun 13;13(1):9584. doi: 10.1038/s41598-023-36623-1.

ReferenceCitation: Valette CA, Filleron T, Debieuvre D, Lena H, Perol M, Chouaid C, Simon G, Quantin X, Girard N. Treatment patterns and clinical outcomes of extensive stage small cell lung cancer (SCLC) in the real-world evidence ESME cohort before the era of immunotherapy. Respir Med Res. 2023 Nov;84:101012. doi: 10.1016/j.resmer.2023.101012. Epub 2023 Mar 27.

ReferenceCitation: Heudel PE, de Montfort A, Debieuvre D, Chouaid C, Carton M, Audigier-Valette C, Filleron T, Chabaud S, Stancu A, Quantin X, Hiret S, Bosquet L, Blay JY. Reduced risk of secondary primary extra pulmonary cancer in advanced/metastatic lung cancer patients treated with immune checkpoint inhibitors. Lung Cancer. 2023 Aug;182:107280. doi: 10.1016/j.lungcan.2023.107280. Epub 2023 Jun 16.

sponsor_collaborators:
UNICANCER
AstraZeneca
Merck Sharp & Dohme LLC
Roche Pharma AG
Pfizer
Bristol-Myers Squibb
Janssen, LP
Amgen
Sanofi
Daiichi Sankyo, Inc.

location_facility: Institut régional du Cancer Montpellier / Val d'Aurelle

location_facility: Institut de cancérologie de l'Ouest - René Gauducheau

location_facility: Groupe Hospitalier Région Mulhouse et Sud Alsace - Hôpital Emile Muller

location_facility: Institut de Cancérologie de l'Ouest - Paul Papin


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

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

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Medtronic Diabetes

location_facility: APHM Marseille (Hôpital de la Conception)

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


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

acronym: INTHEMO

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

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital de la Timone Assistance Publique Hôpitaux de Marseille

lead_sponsor_type: academique


type: Other Identifier

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

acronym: AURAIA

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

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

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

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

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

ReferenceCitation: Diaz Gomez C, Ngantcha M, Le Garjean N, Brouard N, Lasbleiz M, Perennes M, Kerdiles FJ, Le Lan C, Moirand R, Bellou A. Effect of a brief motivational intervention in reducing alcohol consumption in the emergency department: a randomized controlled trial. Eur J Emerg Med. 2019 Feb;26(1):59-64. doi: 10.1097/MEJ.0000000000000488.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Rennes University Hospital

collaborators: Observatoire Français des Drogues et des Toxicomanies (OFDT)

intervention_type: Behavioral


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

acronym: BACLOLIFE

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

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Ethypharm

intervention_type: Drug

status_simplified: Ongoing


title: Objective and Perceived Health Status of Elderly People With Moderate or Severe Haemophilia in France: an Ancillary Study of the FranceCoag Registry

acronym: SENIORHEMO

summary:
Background:

Elderly people with serious haemophilia (PwSH), i.e., with moderate or severe haemophilia, have major comorbidities due to consequences of haemophilia. Also, the comorbidities related to age are added. Despite the existence of numerous studies on the objective health status of elderly PwSH, some limitations may be stated (need to update the results in a more contemporary context, no studies conducted in France, highlighted determinants focused on demographic and clinical factors).

On the contrary, the perceived health status of elderly PwSH has been little described. Only two studies specifically addressed the quality of life (QoL) of elderly PwSH. These studies reported an altered QoL in some domains, in comparison with reference values from the general population. However, some limitations may also be stated (need to bring results in a more contemporary context, no studies conducted in France, highlighted determinants focused on clinical factors).

Since serious haemophilia is a rare disease, studies are often performed on a small number of subjects. The present project relies on the FranceCoag registry, a unique exhaustive national cohort of PwSH followed over time among whom 612 are elderly PwSH.

Objectives:

Main objective: to describe the objective and perceived health status of elderly (≥60 y.o.) PwSH from of a French exhaustive national registry, and to compare their health status with that of the French general elderly population.

Secondary objective: to identify individual (demographic, clinical, social, psycho-cognitive) and collective characteristics (related to healthcare organisation), associated with the objective and perceived health status of elderly PwSH in France.

Materials and Methods:

A national, multicentric, observational, cross-sectional study will be conducted. It will be based on the participation of elderly PwSH already included in the FranceCoag registry. Each eligible participant will receive a questionnaire to complete concerning: objective health status; perceived health status (QoL assessed by the WHOQOL-Old questionnaire); demographic data; social data; psycho-cognitive data (anxious symptoms, depressive symptoms, use of coping strategies, time perspective). Therapeutic and clinical data related to haemophilia will be collected via the FranceCoag registry database. Data concerning healthcare organisation will be collected directly from investigators of Haemophilia Treatment Centres.

The main analysis will consist in the description and comparison of the health status with reference data from the French general elderly population. Standardisation methods will be used to take into account a potential imbalance between the study population and the reference population, related to age and especially to sex, as haemophilia is a predominantly male disease.

The secondary analysis will consist in the identification of potential determinants of the health status. Structural equation models will be performed to take into account the complexity of the relationships between the determinants.

Impact of the proposal Better understanding the impact of the disease on patients' experience is essential in a systematic global perspective of health, that aims to care and support the individual not only as a patient but also as a person in his/her environment. This study based on a registry will allow to improve the knowledge by updating literature data on the health status of elderly PwSH, adding elements to the rare literature data on the perceived health status, providing data in the French specific context, and identifying both classical and more original determinants of health status of elderly PwSH. These results will be used to better identify elderly PwSH at high risk of poor health status, to propose recommendations and to set up actions to offer them an adapted support, and to elaborate new versions of public health plans dedicated to haemophilia or to rare diseases.

time_perspective: Cross-Sectional

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility:
Chu de Besancon
Chu de Bordeaux
Ap-Hm
Chu Le Mans
Chru de Tours
Chu Nantes
Chu de Rennes
Chu Clermont-Ferrand
AP-HP
Chu La Reunion
Chu Brest
Chu de Caen
Chu de Dijon
Centre hospitalier Métropole Savoie
Chu Amiens
Ch Versailles
Chu Toulouse
Chu de Nice
Chu St Etienne
Chu Strasbourg
Chu de Rouen
Chu Poitiers
Chu Montpellier
Chu Reims
Ch Annecy - St Julien
Hospices Civils de Lyon
Chru de Lille
Chu de Nancy

intervention_type: Other


title: Long-term Follow-up of a Multicentre, Non-interventional, Prospective Cohort of Participants Prescribed Epidyolex in France in a Real-life Setting

acronym: OPERA

summary: This is a multi-center, non-interventional and prospective study of patients receiving Epidyolex as part of standard clinical practice in France. The study will state an overview of patient characteristics and clinical history (including age, sex, diagnosis, duration of epilepsy, predominant seizure type, previous medications, current co-medications and Epidyolex dose), and an evaluation of retention rates, safety profile, seizure activity, changes in executive function and quality of life measured in a 2-year follow-up period.

lead_sponsor: Jazz Pharmaceuticals

location_facility: CHU Gabriel Montpied - service neurologie


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

acronym: Recession

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

status: Unknown status

lead_sponsor: Central Hospital, Nancy, France

location_facility:
CHU Ragueil
CHU
CHU Henri Mondor
CHU Saint Roch

status_simplified: Unknown


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

acronym: Far XIENCE V®

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

lead_sponsor: Abbott Medical Devices

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


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

acronym: FRANCE

summary:
The main objective of the study is twofold:

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

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

primary_purpose: Treatment

ReferenceType: background

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

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

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

ReferenceCitation: Lim SN, Lee ST, Tsai YT, Chen IA, Tu PH, Chen JL, Chang HW, Su YC, Wu T. Electrical stimulation of the anterior nucleus of the thalamus for intractable epilepsy: a long-term follow-up study. Epilepsia. 2007 Feb;48(2):342-7. doi: 10.1111/j.1528-1167.2006.00898.x.

lead_sponsor: University Hospital, Grenoble

location_facility: University Hospital of La Pitié-Salpétrière

location_facility: University Hospital of Grenoble Michallon

location_facility: University Hospital of Pierre Wertheimer

intervention_type: Procedure


title: Adherence to Lung Cancer Screening by Low-dose Thoracic CT in Haut-Rhin Department, France.

acronym: DECANPHAR

summary: The main objective of the study is to measure adherence to a lung cancer screening program using low-dose thoracic CT.

primary_purpose: Diagnostic

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace


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

acronym: CORSER

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

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

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

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

ReferenceType: derived

ReferenceCitation: Garcia L, Woudenberg T, Rosado J, Dyer AH, Donnadieu F, Planas D, Bruel T, Schwartz O, Prazuck T, Velay A, Fafi-Kremer S, Batten I, Reddy C, Connolly E, McElheron M, Kennelly SP, Bourke NM, White MT, Pelleau S. Kinetics of the SARS-CoV-2 Antibody Avidity Response Following Infection and Vaccination. Viruses. 2022 Jul 8;14(7):1491. doi: 10.3390/v14071491.

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 - Institut Pasteur

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: MDPI

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

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repositories_concat: PubMed Central;pure.rug.nl

unpaywall_oa_status: hybrid

publisher_dissemination: Oxford University Press

ipd_sharing: Undecided

lead_sponsor: Institut Pasteur

location_facility: Centre Hospitalier Départemental de Vendée


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

acronym: INCOVPED

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

lead_sponsor: University Hospital, Lille

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval

intervention_type: Diagnostic Test


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

acronym: OCARELIFE

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

time_perspective: Other

lead_sponsor: SAMEY

sponsor_collaborators: SAMEY Axonal-Biostatem

location_facility:
Hopital Saint Antoine
Chu Grenoble


title: Registry of Aortic Valve Bioprostheses Established by Catheter

acronym: FRANCE-TAVI

summary: Register multicenter, prospective, open, non-randomized implantation of percutaneous aortic bioprostheses through for the treatment of severe degenerative aortic stenosis Epidemiological data and the 1-year survival of aortic bioprostheses implanted by percutaneous.

ReferenceCitation: Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrie D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012 May 3;366(18):1705-15. doi: 10.1056/NEJMoa1114705.

ReferenceCitation: Auffret V, Lefevre T, Van Belle E, Eltchaninoff H, Iung B, Koning R, Motreff P, Leprince P, Verhoye JP, Manigold T, Souteyrand G, Boulmier D, Joly P, Pinaud F, Himbert D, Collet JP, Rioufol G, Ghostine S, Bar O, Dibie A, Champagnac D, Leroux L, Collet F, Teiger E, Darremont O, Folliguet T, Leclercq F, Lhermusier T, Olhmann P, Huret B, Lorgis L, Drogoul L, Bertrand B, Spaulding C, Quilliet L, Cuisset T, Delomez M, Beygui F, Claudel JP, Hepp A, Jegou A, Gommeaux A, Mirode A, Christiaens L, Christophe C, Cassat C, Metz D, Mangin L, Isaaz K, Jacquemin L, Guyon P, Pouillot C, Makowski S, Bataille V, Rodes-Cabau J, Gilard M, Le Breton H; FRANCE TAVI Investigators. Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI. J Am Coll Cardiol. 2017 Jul 4;70(1):42-55. doi: 10.1016/j.jacc.2017.04.053.

oa_host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

publisher_dissemination: Elsevier

ReferenceCitation: Auffret V, Bedossa M, Boulmier D, Verhoye JP, Ruggieri VG, Koning R, Laskar M, Van Belle E, Leprince P, Collet JP, Iung B, Lefevre T, Eltchaninoff H, Gilard M, Le Breton H. [From FRANCE 2 to FRANCE TAVI: are indications, technique and results of transcatheter aortic valve replacement the same?]. Presse Med. 2015 Jul-Aug;44(7-8):752-60. doi: 10.1016/j.lpm.2015.05.004. Epub 2015 Jul 22. French.

ReferenceCitation: Folliguet TA, Teiger E, Beurtheret S, Modine T, Lefevre T, Van Belle E, Gilard M, Eltchaninoff H, Koning R, Iung B, Verhoye JP, Leprince P, Le Breton H, Lafont A, Parolari A, Barili F. Carotid versus femoral access for transcatheter aortic valve implantation: a propensity score inverse probability weighting study. Eur J Cardiothorac Surg. 2019 Dec 1;56(6):1140-1146. doi: 10.1093/ejcts/ezz216.

evidence: open (via free article)

unpaywall_oa_status: bronze

ReferenceCitation: Benamer H, Auffret V, Cayla G, Chevalier B, Dupouy P, Eltchaninoff H, Gilard M, Guerin P, Iung B, Koning R, Monsegu J, Lantelme P, Le Breton H, Lefevre T, Verhoye JP, Commeau P, Motreff P. Position paper of French Interventional Group (GACI) for TAVI in France in 2018. Ann Cardiol Angeiol (Paris). 2018 Dec;67(6):455-465. doi: 10.1016/j.ancard.2018.09.021. Epub 2018 Oct 28.

ReferenceCitation: Deharo P, Jaussaud N, Grisoli D, Camus O, Resseguier N, Le Breton H, Auffret V, Verhoye JP, Koning R, Lefevre T, Van Belle E, Eltchaninoff H, Gilard M, Leprince P, Iung B, Lambert M, Collart F, Cuisset T. Impact of Direct Transcatheter Aortic Valve Replacement Without Balloon Aortic Valvuloplasty on Procedural and Clinical Outcomes: Insights From the FRANCE TAVI Registry. JACC Cardiovasc Interv. 2018 Oct 8;11(19):1956-1965. doi: 10.1016/j.jcin.2018.06.023. Epub 2018 Sep 12.

ReferenceCitation: Didier R, Gouysse M, Eltchaninoff H, Le Breton H, Commeau P, Cayla G, Glatt N, Glatt B, Gabbas M, Tuppin P, Liepchitz L, Boussac M, Iung B, Gilard M. Successful linkage of French large-scale national registry populations to national reimbursement data: Improved data completeness and minimized loss to follow-up. Arch Cardiovasc Dis. 2020 Aug-Sep;113(8-9):534-541. doi: 10.1016/j.acvd.2020.04.006. Epub 2020 Jul 22.

ReferenceCitation: Van Belle E, Vincent F, Labreuche J, Auffret V, Debry N, Lefevre T, Eltchaninoff H, Manigold T, Gilard M, Verhoye JP, Himbert D, Koning R, Collet JP, Leprince P, Teiger E, Duhamel A, Cosenza A, Schurtz G, Porouchani S, Lattuca B, Robin E, Coisne A, Modine T, Richardson M, Joly P, Rioufol G, Ghostine S, Bar O, Amabile N, Champagnac D, Ohlmann P, Meneveau N, Lhermusier T, Leroux L, Leclercq F, Gandet T, Pinaud F, Cuisset T, Motreff P, Souteyrand G, Iung B, Folliguet T, Commeau P, Cayla G, Bayet G, Darremont O, Spaulding C, Le Breton H, Delhaye C. Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the FRANCE-TAVI Registry. Circulation. 2020 Jan 28;141(4):243-259. doi: 10.1161/CIRCULATIONAHA.119.043785. Epub 2019 Nov 16.

oa_colors: green other

evidence: open (via free pdf)

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

version: submittedVersion

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

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

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories:
HAL
LillOA (Lille Open Archive)

repositories_concat: HAL;LillOA (Lille Open Archive)

lead_sponsor: French Cardiology Society


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

acronym: CARIOCA

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

lead_sponsor: ALK-Abelló A/S

sponsor_collaborators:
ALK-Abelló A/S
ITEC Services


title: Retrospective Study on the Use of CENOBAMATE as Adjunctive Treatment in a Cohort of Patients Suffering From Epilepsy With Focal Onset Seizure (FOS) and Enrolled Into the Early Access Program (EAP) in Germany, France and UK

acronym: CENOR

summary:
Cenobamate is a newly-FDA and EMA approved drug used to treat -focal-onset seizures in adult patients.

The aim of the current study is to analyse retrospectively the overall effectiveness and tolerability of cenobamate from real-world data collected in patients who partecipated in the Early Access Program (EAP) and were treated with cenobamate as adjunctive ASM.

time_perspective: Retrospective

lead_sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A

location_country:
Germany
United Kingdom
France

location_facility: CHRU de Nancy -Hopital Central, Service de Neurologie

location_facility: Epilepsiezentrum Hessen, Klinik für Neurologie, Philipps Universität Marburg - Standort Marburg

location_facility: Centre Hospitalier Universitaire (CHU) de Marseille - Hopital de la Timone

location_facility: Klinik für Neurochirurgie Uniklinik Freiburg -

location_facility: Neurologie - Stroke Unit - Zentrum für Epilepsie

location_facility: Hôpital Pierre Wertheimer - Hopsices Civils de Lyon

location_facility: Epilepsy Center Frankfurt Rhine-Main Neurocenter

location_facility: Klinik und Poliklinik für Epileptologie, Universitätsklinikum Bonn

location_facility: King's College Hospital NHS Foundation Trust

location_facility: CHU de Rouen Hôpital Charles-NicolleService de Neurophysiologie

location_facility: CHRU de Lille - Hôpital Roger Salengro (LILLE)

location_facility: CHU de Strasbourg - Hôpital de Hautepierre


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

acronym: Echo-MG

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

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

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

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

This is an observational study without any intervention.

ReferenceCitation: Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available.

ReferenceCitation: Dietrich CF, Goudie A, Chiorean L, Cui XW, Gilja OH, Dong Y, Abramowicz JS, Vinayak S, Westerway SC, Nolsoe CP, Chou YH, Blaivas M. Point of Care Ultrasound: A WFUMB Position Paper. Ultrasound Med Biol. 2017 Jan;43(1):49-58. doi: 10.1016/j.ultrasmedbio.2016.06.021. Epub 2016 Jul 26.

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

ReferenceCitation: Échographie ciblée pour les cliniciens de soins de première ligne [Internet]. Département de médecine de famille. [Internet]. [cité 1 mai 2020]. Disponible sur: https://www.mcgill.ca/familymed/fr/formation/programme-residence/echographie-ciblee-pour-les-cliniciens-de-soins-de-premiere-ligne

ReferenceCitation: Bécotte G, Garner M, Lanctôt J-F, Parent MC. Position conjointe de l'Association des médecins d'urgence du Québec (AMUQ) et de l'Association des spécialistes en médecine d'urgence du Québec (ASMUQ) adoptée le 7 novembre 2012. :16.

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

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

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

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

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

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

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

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

ReferenceCitation: Buonsenso D, Pata D, Chiaretti A. COVID-19 outbreak: less stethoscope, more ultrasound. Lancet Respir Med. 2020 May;8(5):e27. doi: 10.1016/S2213-2600(20)30120-X. Epub 2020 Mar 20. No abstract available.

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

ReferenceCitation: Delannoy Q. Quel est l'impact diagnostique et thérapeutique de l'échoscopie en pratique courante de Médecine Générale : Étude observationnelle et transversale. [Thèse d'exercice]. Sorbonne Université; 2018.

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

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

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

ReferenceCitation: Rempell JS, Saldana F, DiSalvo D, Kumar N, Stone MB, Chan W, Luz J, Noble VE, Liteplo A, Kimberly H, Kohler MJ. Pilot Point-of-Care Ultrasound Curriculum at Harvard Medical School: Early Experience. West J Emerg Med. 2016 Nov;17(6):734-740. doi: 10.5811/westjem.2016.8.31387. Epub 2016 Sep 12.

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

ReferenceCitation: Bornemann P. Assessment of a Novel Point-of-Care Ultrasound Curriculum's Effect on Competency Measures in Family Medicine Graduate Medical Education. J Ultrasound Med. 2017 Jun;36(6):1205-1211. doi: 10.7863/ultra.16.05002. Epub 2017 Feb 16.

ReferenceCitation: Hoppmann RA, Rao VV, Bell F, Poston MB, Howe DB, Riffle S, Harris S, Riley R, McMahon C, Wilson LB, Blanck E, Richeson NA, Thomas LK, Hartman C, Neuffer FH, Keisler BD, Sims KM, Garber MD, Shuler CO, Blaivas M, Chillag SA, Wagner M, Barron K, Davis D, Wells JR, Kenney DJ, Hall JW, Bornemann PH, Schrift D, Hunt PS, Owens WB, Smith RS, Jackson AG, Hagon K, Wilson SP, Fowler SD, Catroppo JF, Rizvi AA, Powell CK, Cook T, Brown E, Navarro FA, Thornhill J, Burgis J, Jennings WR, McCallum JB, Nottingham JM, Kreiner J, Haddad R, Augustine JR, Pedigo NW, Catalana PV. The evolution of an integrated ultrasound curriculum (iUSC) for medical students: 9-year experience. Crit Ultrasound J. 2015 Dec;7(1):18. doi: 10.1186/s13089-015-0035-3. Epub 2015 Nov 21.

ReferenceCitation: Andersen CA, Holden S, Vela J, Rathleff MS, Jensen MB. Point-of-Care Ultrasound in General Practice: A Systematic Review. Ann Fam Med. 2019 Jan;17(1):61-69. doi: 10.1370/afm.2330.

ReferenceCitation: Steinmetz P, Oleskevich S. The benefits of doing ultrasound exams in your office. J Fam Pract. 2016 Aug;65(8):517-23.

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

ReferenceCitation: Bornemann P, Jayasekera N, Bergman K, Ramos M, Gerhart J. Point-of-care ultrasound: Coming soon to primary care? J Fam Pract. 2018 Feb;67(2):70-80.

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

ReferenceCitation: Zayyan M. Objective structured clinical examination: the assessment of choice. Oman Med J. 2011 Jul;26(4):219-22. doi: 10.5001/omj.2011.55.

ReferenceCitation: Todsen T, Tolsgaard MG, Olsen BH, Henriksen BM, Hillingso JG, Konge L, Jensen ML, Ringsted C. Reliable and valid assessment of point-of-care ultrasonography. Ann Surg. 2015 Feb;261(2):309-15. doi: 10.1097/SLA.0000000000000552.

ReferenceCitation: Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.

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

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

ipd_sharing: Yes

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

lead_sponsor: Sorbonne University

sponsor_collaborators:
Sorbonne University
Aalborg University

location_facility:
Cabinet de médecine générale
Maison Médicale
Maison médicale
Centre Erdian SOS Médecins
CMS Salvador Allende
Cabinet IPSO
Cabinet médical Le Vallet
Cabinet médical
Maison de santé
SOS médecins


type: EudraCT Number

title: A Randomized Controlled Trial to Evaluate the Efficacy, Acceptability and Safety of Event-driven Pre-exposure Prophylaxis for HIV Using TAF/FTC in Men Who Have Sex With Men in Thailand and France

acronym: SimpPrEP

summary:
The purpose of this study is to evaluate the efficacy, acceptability, and safety of a simplified event-driven pre-exposure prophylaxis of HIV based on oral TAF/FTC in HIV-uninfected cisgender men who have sex with men (MSM).

Primary objective: To assess the efficacy of emtricitabine 200 mg + tenofovir alafenamide 25 mg (F/TAF), taken 2 to 24 hours before sexual intercourse followed by a second dose 24 hours after the first intake, in reducing the risk of HIV acquisition in MSM relative to the background HIV incidence rate.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: ANRS, Emerging Infectious Diseases

collaborators: Assistance Publique - Hôpitaux de Paris, FRANCE

location_country: Thailand France

location_facility: STIs Clinic of the Office of Disease Prevention and Control Region 1


title: OCTOPUS: An Observational, Non-interventional, Non-comparative, Retrospective, Multicentre Study in Patients With Advanced Renal Cell Carcinoma (aRCC) Who Initiated Cabozantinib in 2nd Line Under Real-life Setting in France.

acronym: OCTOPUS

summary:
Cabozantinib is an orally bioavailable tyrosine kinase inhibitor (TKI) approved in patients with aRCC previously treated with a Vascular Endothelial Growth Factor (VEGF)-targeted therapy. Cabozantinib has been increasingly used in routine care in second line and more in advanced or metastatic RCC in France.

Cabozantinib effectiveness and safety notably in a real-word setting are now well known, but too many questions that arise during the routine care of patients with aRCC remain unanswered by the current literature.

Obtaining data on cabozantinib effectiveness and treatment pattern in those participants subpopulations will allow physicians to improve patients care.

The aims of this study are to describe the effectiveness - in terms of Duration of Treatment (DOT), Best Overall Response (BOR) and Progression-Free Survival (PFS) - and the safety of second line cabozantinib a real-life setting in France and to address the unanswered questions that arise during the routine care of patients with aRCC treated with cabozantinib in order to improve the care of these participants.

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, annotated 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 study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

lead_sponsor: Ipsen

location_facility: Centre Chirurgie Urinaire et d'Andrologie


title: Cohort Follow-up at 6-12 Months of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic From a University Hospital in France

acronym: COMEBAC 2

summary: From July to September 2020, in a first uncontrolled cohort study, 478 patients who were hospitalized at Bicêtre hospital for COVID-19 and who survived were evaluated at 4 months (publication accepted at JAMA). The current project aims to bring together the means to continue this work during the 2nd epidemic wave.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Dupilumab Effectiveness in Severe Asthma: a Cohort Study From a Nationwide Early Access

acronym: DUPI-France

summary: Dupilumab is a monoclonal anti-IL-4/13Rα antibody developed for severe asthma (SA). In France, mepolizumab was commercialized in February 2018. Before this date, many SA patients had reached a therapeutic dead end, with uncontrolled disease despite maximal available treatment. Upon the request of lung specialists involved in SA, French health authorities approved an early access program (temporary Use Authorization) allowing early access to dupilumab (before EMA's decision) from September 2017 to January 2018, for SA patients demonstrating unacceptable steroids side effects and/or life-threatening exacerbations, irrespective of their T2 status.The aim of this retrospective study was to describe the characteristics of SA patients included in the early access program and to assess changes in asthma control after a 12 months treatment.

ReferenceCitation: Dupin C, Belhadi D, Guilleminault L, Gamez AS, Berger P, De Blay F, Bonniaud P, Leroyer C, Mahay G, Girodet PO, Raherison C, Fry S, Le Bourdelles G, Proust A, Rosencher L, Garcia G, Bourdin A, Chenivesse C, Didier A, Couffignal C, Taille C. Effectiveness and safety of dupilumab for the treatment of severe asthma in a real-life French multi-centre adult cohort. Clin Exp Allergy. 2020 Jul;50(7):789-798. doi: 10.1111/cea.13614. Epub 2020 May 29.

oa_host_type: repository

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

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

repositories_concat: HAL

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

unpaywall_oa_status: green

publisher_dissemination: Wiley

location_facility: Bichat-Claude Bernard University Hospital


title: Prevention At PRImary CAre Level - Increasing HPV Vaccination in Lyon.

acronym: PAPRICA

summary: The PAPRICA implementation trial aims to test the efficacy of an educational intervention about HPV vaccination and targeting general practitioners in Lyon

status: Enrolling by invitation

primary_purpose: Other

ipd_sharing_description: all IPD that underlie results in a publication will be shared after anonymization performed by the PI

location_facility: International Agency for Research on Cancer (IARC)


title: Prevention of Hepatitis B Virus (HBV) Mother-to-child Transmission (MTCT): Impact of Serovaccination in Lariboisiere Hospital, Paris, France.

summary: The prevalence of HBsAg carriage in pregnant women varies in France, according to the native country, with highest rates in those originating from sub-Saharan Africa and Asia (5 to 8 % in Parisian area). The level of HBV-DNA varies according to HBe status and geographical origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). It has been shown that the rate of vertical transmission (Chinese study by Yuan J et al) was 0 % in newborns to mothers whom HBV-DNA was < 105 copies/mL and up to more than 40 % in newborns to mothers with high viral loads > 108 copies/mL, despite HBIg and vaccine at birth. Thus, data are needed concerning the current practices about the prevention of HBV MTCT in France, and their results.

lead_sponsor: Hopital Lariboisière


title: Retrospective and Descriptive Analysis of the Regimens of Treatment With FVIII, FIX and By-passing Agents for Hemophiliacs A or B With or Without Inhibitors, From the Existing Registry BERHLINGO, Before and After the Launch of New Entended Half-life Clotting Factors in Seven Haemophilia Treatment Centers in France

acronym: MOTHIF II

summary: MOTHIF II is a non-interventional, multicenter, retrospective, observational data collection in seven French Haemophilia Treatment Centers of the BERHLINGO network. In the context of the arrival of new extended half-life products, the MOTHIF II study aims to describe the changes in therapeutic management of patients with hemophilia A & B, following the provision of FVIII and FIX extended half-life factors in France; it will also permit to carry out a budget impact analysis to quantify the economic significance of this new era.

lead_sponsor: Nantes University Hospital

location_facility:
Le Mans University Hospital
Nantes University Hospital
Caen university Hospital
Tours University Hospital
Angers University Hospital
Brest University Hospital
Rennes University Hospital


title: Labor Induction in Low-risk Nulliparous Women at 39 Weeks of Gestation to Reduce Cesarean: A Randomized Trial of Induction Versus Expectant Management in France (FRENCH-ARRIVE)

acronym: FRENCH-ARRIVE

summary: The recent ARRIVE trial conducted in United States of America in 2014-2017 demonstrates that elective induction of labor at 39 weeks for nulliparous women did result in a significantly lower frequency of cesarean delivery with no significant differences of adverse perinatal outcomes. But the expected benefits of elective labor induction at 39 weeks have to be confirmed in other settings outside US before considering routine induction of labor for all low-risk nulliparous women at 39 weeks of gestation worldwide.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Ministry of Health, France

appel_a_projets: PHRCN

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

type_etablissement: CH

titre: Déclenchement du travail chez les femmes nullipares à bas risque à partir de 39 semaines d'aménorrhée afin de réduire le taux de césarienne : essai randomisé contrôlé

discipline_principale: obstétrique

nom_porteur: SENTILHES

prenom_porteur: Loic


title: Quality of the Management of Diabetes in Elderly People With Dementia in France. Longitudinal Study in the French National Health System Database During 2010-2015

acronym: DIA-FRADEM

summary: Along with population ageing, the association of chronic conditions such as Alzheimer's Disease and Related Syndromes (ADRS) and diabetes mellitus is increasing in clinical practice. According to ADRS severity, guidelines of diabetes care may be adapted for a personalized monitoring and treatment. The consequences on diabetes complications are not known and can also threaten dementia progression. Based on a nationwide healthcare reimbursement database, the present study aimed to compare diabetes care and the incidence of acute complications between patients with or without ADRS, in a longitudinal perspective focusing on the pivotal period of ADRS identification by the healthcare system.

ReferenceCitation: Wargny M, Gallini A, Hanaire H, Nourhashemi F, Andrieu S, Gardette V. Diabetes Care and Dementia Among Older Adults: A Nationwide 3-Year Longitudinal Study. J Am Med Dir Assoc. 2018 Jul;19(7):601-606.e2. doi: 10.1016/j.jamda.2017.12.006. Epub 2018 Feb 1.

lead_sponsor: University Hospital, Toulouse

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


title: Identification, Molecular Epidemiology Angiosarcoma of the Liver France

acronym: ANGIHE

summary: The purpose of this study is to test the feasibility of identifying incident cases of angiosarcoma of the liver from the network NetSarc.

lead_sponsor: Centre Oscar Lambret

sponsor_collaborators:
Centre Oscar Lambret
Institut de Veille Sanitaire

location_facility:
Institut Bergonié
Centre Léon Bérard
CRLCC Montpellier
Centre Georges François
Institut de Cancérologie Lucien
CHU Strasbourg
Institut Claudius Regaud
Chu / Hopital Trousseau
Hopital Tenon
Centre Oscar Lambret
Hôpital de la TIMONE
Centre Jean Perrin

intervention_type: Biological


type: Registry Identifier

title: Real Life Data for Otezla Evidence: Assessing Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France

acronym: REALIZE

summary:
REALIZE study will include a representative sample of 500 patients with moderate to severe plaque psoriasis for whom the treating dermatologist has decided to begin apremilast treatment in accordance with the local label reimbursement criteria. Patients may be enrolled into the study up to 4 weeks after starting the study treatment.

REALIZE is a longitudinal, multicenter, observational study under real life settings in patients with moderate to severe chronic plaque psoriasis after failure or contra-indication or intolerance to other systemic therapy including ciclosporin, methotrexate, or phototherapy UVA + psoralen (PUVA therapy).

lead_sponsor: Amgen

location_facility: Emile Durkheim Hospital - Saint Jean Health Center

location_facility: Hotel Dieu Hospital, Dermatologic Clinic

location_facility: Private Practice, La Varenne Saint Hilaire

location_facility: Private Practice 2, Chalons-en-Champagne


title: InFocus France Epidemiological Study of Health Burden in Major Hypertriglyceridemia

acronym: InFocus

summary: FCS and MCS patients recruited from 7 academic reference centers were invited to answer a paper or a web questionnaire. Questions encompassed demographics, physical, cognitive and mental symptoms, health care circuit, past and current disease management, satisfaction regarding healthcare providers and impact on daily life.

ipd_sharing_description: according agreement of PI, NSFA Board and complience with CNIL

lead_sponsor: New French Society of Atherosclerosis

sponsor_collaborators:
New French Society of Atherosclerosis
Akcea Therapeutics


title: Knee and Hip OsteoArthritis Long Term Assessment. Prevalence, Natural History, Prognosis Factor, Quality of Life, Health Care Consumption and Social Consequences of Symptomatic Knee and Hip Osteoarthritis in France

acronym: KHOALA

summary:
The aim of the project is to assemble and to follow on a 10-year period a nationwide representative sample of lower limb OA patients.

General objectives: To document the natural history and to identify predictive factors of the evolution and consequences of hip and knee OA in terms of pain, functional disability, structural damage, quality of life, autonomy, medical and health care use and cost of disease.

lead_sponsor: Central Hospital, Nancy, France

location_facility:
Patrice Fardellone
CHU Rangueil
CHU l'Archet
CHU de la Cavale Blanche
CHU Nancy, hopital brabois
Hôpital de la Pitié-Salpêtrière


title: Ibd CAncer and seRious Infections in France (I-CARE 2)

acronym: I-CARE 2

summary:
This is a French prospective longitudinal observational multicentre cohort study.

Primary objective : to assess prospectively the presence and the extent of safety concerns (cancer, serious infections, arterial and venous thrombotic events) in patients with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
APHP Hôpital Saint Antoine
CHU Amiens Picardie


title: Influence of Socio-Economic Factor on Net Survival in Patients With Multiple Sclerosis in France ( ECOVIMUS).

acronym: ECOVIMUS

summary:
Background: In comparison to general population, persons with Multiple Sclerosis have a higher risk to premature death with an estimate reduced life expectancy from 7 to 14 years. However, risk factors of mortality in MS are not well identified and well known. Following the example of studies carry on cancers survival, socioeconomic status (SES) may have an influence on survival in MS.

Objective: The main objective of ECOVIMUS is to estimate net survival according to SES using the European Deprivation Index as a proxy and other major covariates (gender, initial clinical phase and years of disease onset).

Methods: In order to answer to our main objective, we will use a retrospective cohort of MS patients with a medical follow-up in one of the 18 centers included in SURVIMUS II, with a MS onset between 1960 and 2015 and with an informed vital at the date of December 31st, 2015.

The ecological score of deprivation EDI will be used as a proxy of the socioeconomic status and will be attributed from the geolocalisation to patient's residence address. Net survival is directly associated to the notion of "mortality in excess". This mortality will be estimated comparing the observed mortality in MS patients to mortality in the general population. The advantage of this methodological approach is that cause of death is not needed.

Statistical analysis: The influence of socioeconomic status on the excess of mortality will be estimated thanks to a parametric multivariate model of excess rate mortality. This model will be adjusted on other major covariates (gender, age at disease onset, and initial clinical phase) and will include potential complex effects as non-linearity, non-proportionality and interactions.

Expected results: We expect to highlight some differences of net survival in MS patients according to socioeconomic group as it was already shown in cancers. This study will complete information on factors of mortality excess in MS and knowledge on socioeconomic inequalities encountered all along MS disease course.

lead_sponsor: University Hospital, Caen

collaborators: Ecole des Hautes Etudes en Santé Publique

location_facility: University Hospital Centre of Saint-Etienne


title: Nanoparticles Emitted by Aircraft Engines, Impact on the Respiratory Function: Cohort Follow-up Study

summary: The object of this new project is to proceed with investigations with the employees of the cohort for the first study so as to obtain a remote evolution (5 years) of their respiratory function while measuring their nanoparticle exposure. This will enable us to assess the possible link between exposure and respiratory function evolution in the employees

status: Terminated

lead_sponsor: University Hospital, Montpellier

collaborators: LBM- Nanosecurity platform - CEA Grenoble

collaborators: LR2N - Nanosecurity platform - CEA Grenoble


title: Study of the Cannabis Use of Minors Imprisoned in the PACA Region (France)

summary:
To date, there is little data on the consumption of young adults in detention.

The main objective of this project is to document the prevalence of problematic cannabis use before incarceration among juveniles detained in the various detention centers in the PACA

Secondary objectives are to document:

the prevalence of cannabis use over the course of life, last year and last month;
the prevalence of harm and risky behavior associated with the use of a psychoactive substance
associated addictions and first and foremost tobacco
the determinants (socio-demographic, socio-economic, environmental, etc.) of problem use and cannabis use.

This is a multicenter cross-sectional study aimed at establishing an exhaustive picture of the defined population region over a 12-month period.

The holder of the parental authority exercise and the individual agreeing to participate in the study must:

sign an informed consent a no objection card
complete a car book and hetero-questionnaires. The time of handover is evaluated at 30 minutes.

The CAST questionnaire will be used to answer the main purpose of the study and to identify consumers with problematic cannabis use.

CAST scores will be calculated. Abnormal CAST proportions will be presented along with their 95% confidence intervals. The links between the score and the various variables identified as determinants will be tested using uni and multivariate analyzes.

The assessment of the health status and needs of this extremely vulnerable population is a prerequisite for defining specific regional objectives and for establishing a coherent and coordinated effective health intervention within the community. prisoner in France.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hopitaux de Marseille


title: Epidemiology and Prognostic of the Acute Heart Failure in Northeast of France

summary:
EPICAL 2 (Epidemiology and prognostic of the Acute Heart Failure) is an epidemiological, observational, prospective and multicenter study. This study includes at first an exhaustive recording of the cases on a geographic area at East of France, then the recorded patients are followed up in a cohort at least 3 years. This study follows the experiences of the EPICAL study led by our team.

Main objective: To describe the characteristics of the patients affected by acute heart failure and to identify prognostic factors, in particular related to care. More exactly :

To describe the sociodemographic, clinical, biological and therapeutic characteristics of the patients presenting an acute heart failure during hospitalisation and living at East of France ;
To study the short and medium-term morbi-mortality of these patients, and identify the main factors determining the prognosis for survival ;
To evaluate the prognostic impact of the intra and extra-hospital care ;
To identify the evolution of the care's practices of the decompensated heart failure since the EPICAL study (15 years) and their influence on the prognosis of the disease.

Secondary objective: to constitute a biological collection of serum, plasma and urine of patients' sample presenting an acute heart failure.

ReferenceCitation: Al-Gobari M, Agrinier N, Soudant M, Burnand B, Thilly N. Effects of Statins to Reduce All-Cause Mortality in Heart Failure Patients: Findings from the EPICAL2 Cohort Study. Am J Cardiovasc Drugs. 2019 Oct;19(5):497-508. doi: 10.1007/s40256-019-00346-4.

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

repository_institution: reroDoc Digital Library

publisher_dissemination: Springer-Nature


title: Impact of Air Pollution on Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Haut de France. BePoPi Project.

acronym: BePoPi

summary: There is an excess of hospitalization rates for acute exacerbation of COPD in Picardy compared to the national data. A first study realized in Picardy has shown a link between air quality and COPD. Nevertheless, the particles type is unknown and according to it, impact on COPD could be different. The investigator goal is to find a correlation between acute exacerbation of COPD consultation rate and daily ultra thin particles in Haut de France. The investigators will correlate the particles composition with daily acute exacerbation of COPD rate. All COPD patients with a diagnosis of acute exacerbation in emergency room in University Hospital of Amiens-Picardie and Lille, and Clinique de l'Europe between 01/01/2020 and 31/12/2020 will be included. For each patient, home and work address will be collected. The duration of 1 year was chosen to take into account seasonal variations. In parallel, a daily report of the rate of ozone, particles (PM2.5 and PM10), dioxide nitrogen but also odours and pollens will be done by ATMO Haut de France.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

collaborators:
Clinique de l'Europe, Amiens
University Hospital, Lille

appel_a_projets: PHRCI

region: Hauts-de-France

nom_etablissement: CHU AMIENS PICARDIE

acronyme: BEpoPi

titre: Evaluation du rôle de la pollution atmosphérique sur les exacerbations de bronchopneumopathie chronique obstructive (BPCO) dans la région Hauts de France

discipline_principale: prévention pollution bpco exacerbation particule ultrafine combustion

nom_porteur: BASILLE

prenom_porteur: Damien


title: Caries Risk Assessment in Children and Adolescents in the Alpes Maritimes (France)

summary: Identification of caries high risk subjects. Studying the relevance and the distribution of caries risk factors as defined by the HAS, and the part played by the zone of schooling (priority education area or not) Studying the interest of bacteriological tests using the technique of real-time PCR and the laser fluorescence device in the caries risk assessment Thanks to a prospective cohort study conducted over a period of 4 years on a representative sample of pupils and students chosen at random from the 360 primary schools and 89 high schools in the Alpes Maritimes (678 subjects).

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Service d'Odontologie - Hôpital St Roch
Haute Autorité de Santé


title: Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France: a National, Multicenter, Prospective, Non-interventional Study

acronym: RosaLEE

summary: This study is a national, multicenter, prospective, non-interventional study in women with HR+/HER2- locally advanced or metastatic breast cancer (BC), for which a prior clinical decision to initiate ribociclib + endocrine therapy (ET) treatment according to the marketing authorization has been taken and was taken independent and prior to study participation decision.

lead_sponsor: Novartis Pharmaceuticals


title: Description of the Use of Quetiapine Extended Release (XR) in Real-life Practice in France

summary: The aim of the study is to describe patient characteristics (demographic and clinical) and the patterns of use of Quetiapine XR in patients receiving the drug for the first time in real-life practice regardless the final diagnosis.

lead_sponsor: AstraZeneca

location_facility:
Research SIte
research Site
Research Site
Reserach Site


title: Additional Autoimmune Diseases With Type 1 Diabetes in Children and Adolescents at Diabetes Diagnostic and During Follow-up : a Monocentric Study in France

summary: This study aims to describe the prevalence of additional autoimmune diseases and their specific antibodies at type 1 diabetes (T1D) diagnosis, and their incidence rate during follow-up, for children and adolescents. It also aims to describe the characteristics of the pediatric cohort followed since 2014 for type 1 diabetes by one of France's centers of reference for paediatric diabetes.


title: Epidemiology of Gunshot Wounds Injuries Admitted in Intensive Care Unit in France: a Retrospective Multicenter Observational Study

summary:
In civilian practice, the incidence of firearm violence depends on the country. In high income countries, most cases are reported in the USA or South Africa. In these countries, gunshot wounds (GSW) represent 20% of death cases in trauma centers, more than motor vehicle collisions.

The mortality in civilian practice occurs during the first 24 hours following GSW, mainly due to hemorrhage and traumatic brain injury, though long term effects on physical and psychological outcomes have also been shown.

Some factors of mortality specific to GSW have been established: multiples wounds, homicide vs suicide attempt, impact zone, or firearm caliber.

Few specific guidelines have been published concerning civilian GSW management. These cases are mostly treated in standard guidelines, such as hemorrhagic shock or traumatic brain injury guidelines. As in other trauma mechanisms, the "platinum ten minutes and golden hour" concept is applicable.

In Europe, the incidence of civilian GSW is much lower and few European studies have been published recently. Penetrating injuries in Europe are less likely to be GSW, and are more often self-inflicted than in the USA. In addition, European studies are heterogeneous, due to the difference in populations, healthcare systems and GSW being grouped with stabbing wounds under the label "penetrating trauma".

However, there is a global concern in Europe regarding a potential rise of GSW, with higher severity score than conventional trauma patients and often necessitate ICU admission. Studies analyzing data from different European countries show significantly different ICU admission rates for overall GSW, ranging from 17% up to 30%.

Therefore, the investigators conducted a multicenter, retrospective study on four French University Hospitals aiming to describe the epidemiology (mortality and type of organ damage) and identify prognosis factors of civilian GSW admitted in ICU.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Impact of Early Palliative Care on Quality of Life and Survival of Patients With Non-small-cell Metastatic Lung Cancer in Northern France

acronym: IMPAQ

summary: Single-center, prospective, controlled, open-label, randomized, two parallel arms comparing early Palliative care versus Standard care in patients with non-small-cell metastatic lung cancer

primary_purpose: Supportive Care

ReferenceCitation: Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.

lead_sponsor: University Hospital, Lille

collaborators:
Santelys Association
Novartis

sponsor_collaborators:
University Hospital, Lille
Santelys Association
Novartis


title: Evaluation of the Daily Practices of ECMO Veino-arterial and Their Ethical Implications in France: Multicenter Observational Study (Evaluation of Professional Practice)

acronym: EVAPE

summary:
Short-term circulatory support (ECMO/ECLS) has become a common emergency resuscitation support.

Currently, the indication of the ECMO/ECLS relies more on clinic, biological and imagery arguments than on a real consensus.During the care of a patient under ECMO/ECLS, various stakeholders are involved in the implementation and its medical and paramedical management. Everyone, with their knowledge and experience, has an opinion on the relevance of this therapy.

ipd_sharing_description: The data will not be disclosed individually to other researchers. The analysis is done in a global way

lead_sponsor: Centre Hospitalier La Chartreuse

sponsor_collaborators:
Centre Hospitalier La Chartreuse
Elodie BERG


title: Implant-Associated P. Aeruginosa Bone And Joint Infections : Experience In A Regional Reference Center In France

summary: The aim of this study is to describe the bone or joint infection due to Pseudomonas aeruginosa in patients having implant.

lead_sponsor: Hospices Civils de Lyon


title: Easypod Connect: A National, Multicentre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using Easypod™ Electromechanical Device for Growth Hormone Treatment

acronym: ECOS FRA

summary: This is a National, Multicentre, Observational Registry to study adherence and long term outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment from hospitals in France and to assess the level of adherence of subjects receiving SAIZEN® via Easypod™.

ReferenceCitation: Koledova, E. et al. (2017) Analysis of results from the global, 5-year Easypod™ Connect Observational Study (ECOS) study in children with growth disorders. 10th International Meeting for Pediatric Endocrinology; 2017 Sep 14-17; Washington, DC.

ReferenceCitation: Wit, JM. et al. (2017) Effect of adherence on the 2-year growth response to growth hormone treatment in prepubertal children with idiopathic isolated growth hormone deficiency participating in the EasypodTM Connect Observational Study (ECOS). 10th International Meeting of Paediatric Endocrinology; 2017 Sep 14-17; Washington, DC.

lead_sponsor: Merck KGaA, Darmstadt, Germany

sponsor_collaborators:
Merck KGaA, Darmstadt, Germany
Merck Serono S.A.S, France


title: Evaluation of a Mobile Mammography Unit. A Randomized Cluster Trial Protocol of a Population Health Intervention Research to Reduce Breast Cancer Screening Disparities in Normandy, France (Mammobile)

acronym: Mammobile

summary: Organized breast cancer screening (OBCS) has been implemented nationwide since 2004 inFrance, but the participation rate remains low (51%) and inequities in participation were reported. Strategies as mobile mammography units could be effective to increase participation in OBCS and reduce inequities, especially in underserved areas in regard to this screening. Our main objective is to evaluate this device and to identify how to incorporate a mobile unit in the OBCS with a view to tackle territorial inequities in OBCS participation. The project will be conducted as a randomized controlled cluster trial in 2022-2024, in remote areas of 4 French departments. The main intervention is to propose an appointment at the mobile unit in complement to the current OBCS in these remote areas. In addition, few weeks before this intervention, local actors will carry out actions to promote OBCS with mobile unit specific information tools. This randomized controlled trial will provide a high level of evidence in assessing the mobile unit effects on participation and inequities.

ReferenceCitation: Guillaume E, Rollet Q, Launay L, Beuriot S, Dejardin O, Notari A, Crevel E, Benhammouda A, Verzaux L, Quertier MC, Launoy G. Evaluation of a mobile mammography unit: concepts and randomized cluster trial protocol of a population health intervention research to reduce breast cancer screening inequalities. Trials. 2022 Jul 8;23(1):562. doi: 10.1186/s13063-022-06480-w.

repository_institution: Research Square - Research Square

repository_normalized: Research Square

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

ipd_sharing_description: Individual data is collected as part of the usual organization of organized breast cancer screening. It is the authorized structure that manages these data.

lead_sponsor: Université de Caen Normandie

collaborators: Normandy regional cancer screening coordination center


title: A Retrospective and Prospective Non-interventional Open Label Study to Assess the Real Life of Treatment-naive Patients With Wet Age-related Macular Degeneration in Routine Clinical Practice in France and Starting an Anti VEGF Therapy With Aflibercept

acronym: RAINBOW

summary: The purpose of this study is to collect real-life data on patients with wet age related macular degeneration (AMD) for whom treatment with Eylea was initiated

ReferenceCitation: Cohen SY, Dominguez M, Coscas F, Faure C, Baillif S, Oubraham H, Kodjikian L, Weber M; RAINBOW study investigators. Final 4-year results of the RAINBOW real-world study: intravitreal aflibercept dosing regimens in France in treatment-naive patients with neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2023 Apr;261(4):959-969. doi: 10.1007/s00417-022-05900-6. Epub 2022 Nov 18.

repositories_concat: PubMed Central

ReferenceCitation: Weber M, Kodjikian L, Coscas F, Faure C, Aubry I, Dufour I, Cohen SY. Impact of intravitreal aflibercept dosing regimens in treatment-naive patients with neovascular age-related macular degeneration in routine clinical practice in France: results from the RAINBOW study. BMJ Open Ophthalmol. 2020 Apr 6;5(1):e000377. doi: 10.1136/bmjophth-2019-000377. eCollection 2020.

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: British Medical Journal

ReferenceCitation: Weber M, Dominguez M, Coscas F, Faure C, Baillif S, Kodjikian L, Cohen SY. Impact of intravitreal aflibercept dosing regimens in treatment-naive patients with neovascular age-related macular degeneration: 2-year results of RAINBOW. BMC Ophthalmol. 2020 May 25;20(1):206. doi: 10.1186/s12886-020-01468-z.

ReferenceCitation: Weber M, Velasque L, Coscas F, Faure C, Aubry I, Cohen SY; RAINBOW study investigators. Effectiveness and safety of intravitreal aflibercept in patients with wet age-related macular degeneration treated in routine clinical practices across France: 12-month outcomes of the RAINBOW study. BMJ Open Ophthalmol. 2019 Apr 9;4(1):e000109. doi: 10.1136/bmjophth-2017-000109. eCollection 2019.

lead_sponsor: Bayer

sponsor_collaborators:
Bayer
Regeneron Pharmaceuticals


title: Research for Genetic Factors Involved in Congenital Dislocation of Hip: Genome-wide Association Study in Grand West France

acronym: GENETHIP

summary:
The main objective is to identify the genes involved in congenital dislocation of the hip.

The secondary objectives are to measure the association between mechanical risk factors and congenital dislocation of hip and study the interactions between these factors and genetic factors.

lead_sponsor: University Hospital, Brest


title: Follow-up of Patients Referred to Unscheduled Care Centers by the Emergency Call Center in the Haut-Rhin Department, France

summary: The objective of this study is to determine the follow-up of patients who were referred by the Emergency Call Center of the Haut-Rhin department to an Unscheduled Care Centers (UCC) and to determine whether they actuallly went to a UCC following their call, or if they were taken in charge by another care facility.

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace


title: Clinical Presentation and Renal Outcome of Patients With Tuberous Sclerosis Complex and/or Renal Angiomyolipoma in the Great West Region of France

acronym: TSAR

summary: This study aims to investigate the factors (clinical, care-related and genetic) affecting renal outcome in patients with TSC (Tuberous sclerosis complex)

location_facility:
CHU Rennes
CHU Brest


title: Acceptability and Persistence of the Use of a Patient-centred E-health Tool for Lupus Patients Followed in a Specialised Centre in France

acronym: e-LUPUS

summary:
Systemic lupus erythematosus (SLE) is a complex disease whose evaluation in daily practice and clinical research requires consideration of several aspects, in particular disease activity and quality of life.

Health systems are increasingly using Patient Reported Outcome measures (PRO) data to measure different dimensions of the disease and its experience.

In addition, there is a growing number of "e-health" tools for patients. Indeed, the collection of health-related data via an electronic system makes it possible to modernise and facilitate communication between patients and doctors within the framework of medical follow-up and therapeutic education. Nevertheless, very few studies measure the acceptability and effective long-term use of such tools, particularly in the context of SLE.

The Sanoïa patient platform is a digital tool already used in therapeutic areas similar to SLE (discoid lupus erythematosus and rheumatoid arthritis), offering a guarantee of safety and a reduced individual cost.

The availability of this health-related quality of life data collection tool via a site and a mobile application adapted to patients with SLE should:

Facilitate the collection by patients of their quality of life as part of their routine follow-up (patient access)
Limit the impact of patients' clinical profiles on the frequency of the collection of quality of life data
Enable internal medicine specialists to systematically use their patients' quality of life data during consultation (physician access).

This study therefore proposes to evaluate this digital platform within the framework of SLE by measuring the distribution of access by physicians according to the data reported by patients and according to the characteristics of the facilities where the subjects were recruited for the study. These data will allow us to evaluate the influence of factors extrinsic to patients on the adoption of the tool. This area has been very poorly evaluated in the few studies that have focused on the adoption of such tools.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Study of the Relation Between the Consumption of Psychoactive Substances and Pain, in Patients Suffering or Surviving From Cancer and Followed in France: Cross-sectional Pilot Study

acronym: CAPS

summary:
Pain is one of the most prevalent symptoms during and after cancer. Pain can be the consequence of several situations (disease progression, surgery, and anticancer drugs). However, pain can frequently be associated with a substance use disorder (alcohol, tobacco, drugs, and illicit products such as cannabis). The relationship between substance use and pain is known to be complex and interdependent, i.e. pain can reinforce substance use and substance use can promote pain. However, few data in the literature are available on the use of psychoactive substances in relation to pain in the context of cancer (cancer patients and cancer survivors). Moreover, the scientific literature agrees on the fact that these elements are little studied and underestimated in the clinic.

The investigators hypothesize that, in cancer patients or cancer survivors, the prevalence of the use of psychoactive substances would be higher in the presence of pain, and would be associated with its intensity and its impact on the quality Health-Related Living (HRQoL).

The main objective of this study will be to compare, in an adult population of patients suffering from cancer or having had cancer, the prevalence of the consumption of psychoactive substances in painful patients compared to non-painful patients.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.

acronym: IVANHOE

summary:
Universal rotavirus vaccination program for infants born in Brest after February 2007, applied by the Centers for Maternal and Infant Health Protection, pediatricians and general practitioners.

Prospective surveillance of hospitalizations for gastroenteritis within the Pediatric Units of Brest University Hospital with systematic testing for Rotavirus.

Evaluation of the impact of the vaccination program on rotaviral gastroenteritis hospitalizations from 2007-2008 and 2008-2009, by comparison with epidemiological data from 2002-2007 in the absence of vaccination.

The principal judgement criterion is the number of pediatric hospitalizations for rotaviral GEA during the 2008-2009 epidemic in children A) under the age of 2 and B) residing in the suburbs of Brest.

ReferenceCitation: Roue JM, Nowak E, Le Gal G, Lemaitre T, Oger E, Poulhazan E, Giroux JD, Garenne A, Gagneur A. Impact of rotavirus vaccine on premature infants. Clin Vaccine Immunol. 2014 Oct;21(10):1404-9. doi: 10.1128/CVI.00265-14. Epub 2014 Jul 30.

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Gagneur A, Nowak E, Lemaitre T, Segura JF, Delaperriere N, Abalea L, Poulhazan E, Jossens A, Auzanneau L, Tran A, Payan C, Jay N, de Parscau L, Oger E; IVANHOE investigators. Impact of rotavirus vaccination on hospitalizations for rotavirus diarrhea: the IVANHOE study. Vaccine. 2011 May 12;29(21):3753-9. doi: 10.1016/j.vaccine.2011.03.035. Epub 2011 Apr 13.

sponsor_collaborators:
University Hospital, Brest
MCM Vaccines B.V.


title: Multicentric Study of Comparison of the Effectiveness of a Web Fracture Liaison Service (e_FLS) to Fracture Liaison Services in France: the evAB Study

acronym: evAB

summary: The purpose of this study is to compare web FLS model (e_FLS) to conventional FLS in terms of increasing the proportion of patients receiving an antiosteoporotic treatment in the year after a low trauma fracture.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
French Society of Rheumatology

location_facility: Cochin Hospital, Rheumatology Department


title: Estimation Des années de Vie ajustées Sur l'incapacité à La réunion et Comparaison à la France métropolitaine et Aux Pays de la Zone Océan Indien

acronym: AVIRON

summary: AVIRON study aims at estimating the burden of various causes of death and morbidity in the Reunion Island population.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Intra Hospital Mortality Risk Factors in Patients Admitted to Cardiac Intensive Care Units in 2017 in France: A Nationwide Retrospective Observational Cohort Study Using Data From the French Hospital Discharge Database

acronym: USIC -BNAT

summary:
Retrospective, observational cohort study.

Objectives:

To identify intra hospital mortality risk factors in patients admitted admitted to cardiac intensive care units (CICU). The clinical main endpoint will be the observed percentage of deaths that occured during the year 2017 in french CICU.

To identify the length of stay key determiners of patients admitted in french CICU.

The study will use data from one of the french nationwide healthcare systems database (SNDS) : the national hospital discharge database (PMSI) to be precise.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Predictive Factors of Recurrence of Non Functioning Pituitary Adenomas : a Retrospective Study of 220 Patients in the Reims University Hospital, France

summary: Non functioning pituitary adenomas (NFPAs) are the most common pituitary adenomas. Their growth is usually slow and diagnosis is often made in the context of masse effect .The therapeutic alternatives are surgery and radiotherapy such as fractionated stereotactic radiotherapy. Nowadays, there is no clinical or histological prognostic factor to allow an individualized follow-up and recurrence could happen 10 or 15 years after the first surgery. In this study, the investigators evaluate NFPAs recurrence rate after surgery and try to find predictive factors of recurrence to personalized the follow-up of each patient.

lead_sponsor: CHU de Reims


title: Coordinated Research on Prolonged Symptoms and Reasons for Consultation in Town Medicine Associated With SARS-COV-2 Infection: a Transversal Study in Town in the Hauts de France Region

summary:
Several publications document the occurrence of prolonged or late-onset symptoms beyond 3 weeks after the first clinical manifestations of SARS-COV2 infection. These manifestations may be related to thromboembolic or inflammatory events or other mechanisms that are not yet well understood. The psychosomatic origin secondary to psychiatric disorders prior to the infection or in reaction to it is also to be evoked. The identification of the clinical manifestations observed, and their clinical and paraclinical evolution are essential to better understand the natural evolution of COVID-19, to specify the physiopathological mechanisms and to identify potential avenues of management for the patients. In addition, the impact of COVID-19 infection on primary care visits is not known. In general practice, these patients benefit from explorations and even diagnoses that may explain the persistence of symptoms (autoimmune diseases, thrombosis, somatoform disorders, hyperventilation syndrome, etc.).

The objective of the COCO_Vi_LATE project is to carry out a cross-sectional study of patients presenting persistent and/or recurrent symptoms after an infection with SARS-COV-2 who will be compared to individuals with a short form of infection with COVID-19

lead_sponsor: Tourcoing Hospital


title: Vascular Access Complications for Therapeutic Apheresis in Nephrology : a Retrospective Observational Study in North-East France.

acronym: VACTANE

summary: The aim of this study is to describe vascular access complications which are used for therapeutic apheresis in Nephrology.

lead_sponsor: Central Hospital, Nancy, France


title: Comparison of Environmental Factors Between the Areas of Over- and Under-incidence of Crohn's Disease in the Haut de France Region, by the Study of Dental Exposomes

acronym: EXPOSOMES

summary: the aim of this preliminary observational study is to compare external exposomes from 10 teeth issued through 10 subjects living in high incidence of crohn's disease area and 10 teeth issued through 10 subjects living in low incidence of crohn's disease area.


title: Retrospective Study on the Relationship Between Social Status and Use of Healthcare Services During the Confinement Period Linked to the COVID-19 Epidemic in Bas-Rhin, France

summary: Epidemics have always affected the most disadvantaged social categories more intensely. This social inequality is expressed in the use of care and emergencies: greater frequency but also greater seriousness. Our hypothesis is that, during a period of confinement, the most disadvantaged populations are more affected by the COVID-19 infection than the rest of the population. The number of remedies is greater, as is the severity of the forms of infection.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Adult Emergency Department - Strasbourg University Hospitals


title: Long-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis From France Who Completed the Global, Multinational Trial (WA19977)

summary: This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study. Patients will continue to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.

lead_sponsor: Hoffmann-La Roche


title: Analysis of the Genotype/Phenotype Relationship in the Fuchs' Corneal Endothelial Dystrophy in France. The French Fuchs' Follow-up Study, F3S

summary: The pathophysiology of the most common corneal endothelial dystrophies (Fuchs' Corneal Endothelial Dystrophy (FECD)) is beginning to be dismembered. One of the most common genetic anomalies is a triplet repetition in one of the introns of the Transcription Factor 4 (TCF4) gene located on chromosome 18. However, the number of repetitions varies greatly from one patient to another.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

collaborators: Kyoto University, Graduate School of Medicine


title: Analysis of the Genotype/Phenotype Relationship in the Fuchs' Corneal Endothelial Dystrophy in France. The French Fuchs' Follow-up Study (Phase 2), F3S2

summary: The pathophysiology of the most common corneal endothelial dystrophies (Fuchs' Corneal Endothelial Dystrophy, FECD) is beginning to be dismembered. There is a significant heterogeneity in the clinical forms and the investigators have just highlighted a great diversity of histological forms that seem to define distinct groups.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

sponsor_collaborators: Kyoto University, Graduate School of Medicine


title: Influence of Food Preferences on the Occurrence of Undernutrition in Treated Patients for Bronchopulmonary Carcinoma Non-small Cell Stage IV

acronym: ONCOGOU

summary:
The study will be offered to patients with non-small cell lung carcinoma diagnosed at stage IV and receiving first-line treatment.

The patient will benefit from a complete assessment at inclusion (clinical exam, imagery, biological exam, dietary consultation, test LFQP.

At the end of this 1st evaluation, patients in whom the diagnosis of undernutrition is made will benefit from dietary management with personalized advice that will take into account the symptoms of cancer, the possible side effects of treatments as well as the social environment.

Every two cures, i.e. every 4 to 6 weeks, these examens will be performed until the occurrence of an event (progression of the disease according to the RECIST criteria, death or change of therapeutic line). At the end of these assessments, patients will benefit from dietary management with a readjustment of personalized advice that will take into account the difficulties highlighted during the assessment.

lead_sponsor: Centre Georges Francois Leclerc


title: Study of the Practice of Debiri in France: Indications, Associations to Systemic Treatments, Efficiency, Tolerance - Prospective Practice Survey

summary: In order to extract the profiles of patients receiving DEBIRI treatment at best, the investigators proposed the establishment of a national prospective cohort to collect information on the greatest number of patients treated with DEBIRI. This cohort will allow a better understanding of the effectiveness, tolerance, feasibility and differences of practices at national level for this approach. These data will assist in the development of clinical trials in situations that appear to be most promising in clinical practice.

status: Active, not recruiting

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Centre Hospitalier Intercommunal St. Aubin les Elbeuf


title: Family Experiences After International Adoption

acronym: VF-ADIN

summary: The purpose of this study is to determine the types of experiences faced by families in France who have adopted a child internationally. In addition, internationally adopted adolescents are invited to respond to questions about their own personal experiences.

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ReferenceCitation: Sue DW, Capodilupo CM, Torino GC, Bucceri JM, Holder AM, Nadal KL, Esquilin M. Racial microaggressions in everyday life: implications for clinical practice. Am Psychol. 2007 May-Jun;62(4):271-86. doi: 10.1037/0003-066X.62.4.271.

lead_sponsor: Centre Hospitalier St Anne

location_facility:
Hospital MIGNOT
Hospital Enfants CHU du BOCAGE
Hospital NECKER
Hospital SAINTE ANNE