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, Carrié 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.

ReferenceType: result

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, Rodés-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.

family: Auffret

full_name: Vincent Auffret

given: Vincent

family: Lefevre

full_name: Thierry Lefevre

given: Thierry

family: Van Belle

full_name: Eric Van Belle

given: Eric

family: Eltchaninoff

full_name: Hélène Eltchaninoff

given: Hélène

family: Iung

full_name: Bernard Iung

given: Bernard

family: Koning

full_name: René Koning

given: René

family: Motreff

full_name: Pascal Motreff

given: Pascal

family: Leprince

full_name: Pascal Leprince

family: Verhoye

full_name: Jean Philippe Verhoye

given: Jean Philippe

family: Manigold

full_name: Thibaut Manigold

given: Thibaut

family: Souteyrand

full_name: Geraud Souteyrand

given: Geraud

family: Boulmier

full_name: Dominique Boulmier

given: Dominique

family: Joly

full_name: Patrick Joly

given: Patrick

family: Pinaud

full_name: Frédéric Pinaud

given: Frédéric

family: Himbert

full_name: Dominique Himbert

family: Collet

full_name: Jean Philippe Collet

family: Rioufol

full_name: Gilles Rioufol

family: Ghostine

full_name: Said Ghostine

given: Said

family: Bar

full_name: Olivier Bar

given: Olivier

family: Dibie

full_name: Alain Dibie

given: Alain

family: Champagnac

full_name: Didier Champagnac

given: Didier

family: Leroux

full_name: Lionel Leroux

given: Lionel

full_name: Frédéric Collet

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Auffret V, Bedossa M, Boulmier D, Verhoye JP, Ruggieri VG, Koning R, Laskar M, Van Belle É, Leprince P, Collet JP, Iung B, Lefèvre 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. Review. French.

title: De FRANCE 2 à FRANCE TAVI : les indications, la technique et les résultats du remplacement valvulaire aortique percutané sont-ils les mêmes ?

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.

name: Department of Cardiac Surgery and Cardiology, Assistance Publique-Hôpitaux de Paris, Hospital Henri Mondor, University Paris 12 UPEC, Creteil, France

name: Cardiac Surgery Department, Saint Joseph Hospital, Marseille, France

name: Cardiac Surgery Department, Cardiologic University Hospital, Lille, France

name: Paris South Cardio-vascular Institute, Jacques-Cartier Private Hospital, Massy, France

name: Department of Cardiology, University of Lille 2, Regional University Hospital Center of Lille, National Institute of Health and Medical Research U1011, University Hospital Federation Integra, Lille, France

name: Department of Cardiology, La Cavale Blanche University Hospital Center, Optimization of Physiological Regulations, Science and Technical Training and Research Unit, University of Western Brittany, Brest, France

name: Cardiology Service, Rouen–Charles-Nicolle University Hospital Center, National Institute of Health and Medical Research U644, Rouen, France

name: Cardiology Service, Saint Hilaire Clinic, Rouen, France

name: Department of Cardiology, University Hospital Department and Paris-Diderot University, Public Assistance Hospitals of Paris, Bichat Hospital, Paris, France

name: Thoracic and Cardiovascular Surgery Service, Pontchaillou University Hospital Center, University of Rennes 1, Signal and Image Treatment Laboratory (LTSI), National Institute of Health and Medical Research U1099, Rennes, France

name: Cardiac Surgery Department, Sorbonne–Pierre-et-Marie-Curie University, Public Assistance Hospitals of Paris, Groupe Hospitalier de la Pitié Salpêtrière (GHPS), Paris, France

name: Cardiology and Vascular Diseases Service, Pontchaillou University Hospital Center, Center for Clinical Investigation 804, University of Rennes 1, Signal and Image Treatment Laboratory (LTSI), National Institute of Health and Medical Research U1099, Rennes, France

name: Paris Cardiovascular Research Center, INSERM Unit 970, Paris, France

name: Université Paris Descartes, Sorbonne Paris Cité, Paris, France

name: Cardiology Department, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Paris, France

name: Universitary Cardiac Surgery, Policlinico S. Donato IRCCS, University of Milan, Milan, Italy

name: Department of Cardiovascular Surgery, S. Croce Hospital, Cuneo, Italy

journal_name: European Journal of Cardio-Thoracic Surgery

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, Lefèvre 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, Lefèvre 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.

name: Département de Cardiologie, Institut Coeur Poumon, Inserm U1011, Institut Pasteur de Lille, EGID (E.V.B., F.V., N.D., A. Cosenza, G. Schurtz, S.P., E.R., A. Coisne, T. Modine, M.R., C.D.)

name: Department of Biostatistics, EA 2694-Santé Publique: épidémiologie et Qualité des Soins (J.L., A.D.)

name: CHU de Lille, Université de Lille, France. CHU Pontchaillou, Service de Cardiologie et Maladies Vasculaires, CIC-IT 804, Université de Rennes 1, Laboratoire de Traitement du Signal et de l’Image, Inserm U1099, Rennes, France (V.A., J.P.-V., H.L.B.).

name: Institut Cardiovasculaire Paris-Sud, Hôpital Privé Jacques-Cartier, Massy, France (T. Lefèvre).

name: CHU Rouen–Charles-Nicolle, Service de Cardiologie, Inserm U644, Rouen, France (H.E.).

name: CHU Guillaume et René Laennec, Institut du Thorax, Service de Cardiologie, Nantes, France (T. Manigold).

name: CHU La Cavale Blanche, Département de Cardiologie, Optimisation des Régulations Physiologiques, UFR Sciences et Techniques, Brest, France (M.G.).

name: AP–HP, Hôpital Bichat, Département de Cardiologie, Université Paris-Diderot, France (D.H., B.I.).

name: Clinique Saint-Hilaire, Service de Cardiologie, Rouen, France (R.K.).

name: AP–HP, CHU La Pitié-Salpêtrière, Service de Cardiologie, Paris, France (J.-P.C., P.L.).

name: Hôpital Henri-Mondor Assistance Publique Hôpitaux de Paris, Département de Cardiologie, Créteil, France (E.T.).

name: CHU Nîmes, Cardiologie, Université Montpellier, Nimes, France (B.L., G.C.).

name: Hopital Saint-Joseph, Fédération de Cardiologie, Marseille, France (P.J.).

name: CHU Louis Pradel, Division de Cardiologie, Centre d’Investigation Clinique de Lyon (CIC), Bron, France (G.R.).

name: Centre Marie Lannelongue, Département de Cardiologie, Le Plessis Robinson, France (S.G.).

name: Clinique Saint Gatien, Service de Cardiologie, Tours, France (O.B.).

name: Institut Mutualiste Montsouris, Département de Cardiologie, Paris, France (N.A.).

name: Clinique du Tonkin, Service de Cardiologie, Villeurbanne, France (D.C.).

name: CHU de Strasbourg, Nouvel Hôpital Civil, Département de Cardiologie, Université de Strasbourg, France (P.O.).

name: CHU Besançon, Cardiologie, Hopital Jean Minjoz, Besançon, France (N.M.).

name: CHU de Toulouse, Département de Cardiologie, Inserm U1048, Université de Toulouse 3, France (T. Lhermusier).

name: Hôpital Cardiologique du Haut-Lévêque, Département de Cardiologie Interventionnelle, Université de Bordeaux, Pessac, France (L.L.).

name: CHU Arnaud de Villeneuve, Service de Cardiologie, Montpellier, France (F.L., T.G.).

name: CHU d’Angers, Service de Chirurgie Cardiaque, CNRS UMR 6214, INSERM 1083, Université d’Angers, France (F.P.).

name: CHU La Timone Assistance Publique Hôpitaux de Marseille, Département de Cardiologie, Inserm UMR1062, INRA UMR 1260, Université d’Aix-Marseille, France (T.C.).

name: CHU Gabriel Montpied, Département de Cardiologie, ISIT, CaVITI, CNRS (UMR-6284), Université d’Auvergne, Clermont-Ferrand, France (P.M., G. Souteyrand).

name: CHU de Nancy, Service de Chirurgie Cardiovasculaire, Vandoeuvre-lès-Nancy, France (T.F.).

name: Polyclinique les Fleurs, Cardiologie, Ollioules, France (P.C.).

name: Hôpital Privé Clairval, Service de Cardiologie, Marseille, France (G.B.).

name: Clinique Saint Augustin, Service de Cardiologie, Bordeaux, France (O.D.).

name: Hôpital Européen Georges Pompidou, Paris, France (C.S.).

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

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

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

publisher: Ovid Technologies (Wolters Kluwer Health)


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.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


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

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

ipd_sharing: Yes

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)

intervention_type: Behavioral

lead_sponsor_type: industriel

status_simplified: Unknown


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.

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: Nantes University Hospital

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

status_simplified: Completed


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: 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.

ReferenceType: derived

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 Bourdellès G, Proust A, Rosencher L, Garcia G, Bourdin A, Chenivesse C, Didier A, Couffignal C, Taillé 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.

name: Groupe Hospitalier Universitaire AP‐HP Nord‐Université de Paris Hôpital Bichat Service de Pneumologie et Centre de Référence constitutif des Maladies Pulmonaires Rares Inserm UMR 1152 Paris France

family: Dupin

full_name: Clairelyne Dupin

given: Clairelyne

sequence: first

name: Groupe Hospitalier Universitaire AP‐HP Nord‐Université de Paris Hôpital Bichat Département d’Epidémiologie Biostatistiques et Recherche Clinique Unité de Recherche Clinique Paris France

name: Clinical Investigation Center CIC‐EC 1425 Inserm Paris France

family: Belhadi

full_name: Drifa Belhadi

given: Drifa

sequence: additional

name: Pôle des Voies Respiratoires Hôpital Larrey CHU de Toulouse Toulouse France

name: Centre de Physiopathologie Toulouse Purpan INSERM U1043 CNRS UMR 5282 Université Toulouse III Toulouse France

name: INSERM, F‐CRIN Clinical Research Initiative In Severe Asthma: a Lever for Innovation & Science (CRISALIS) Toulouse France

family: Guilleminault

full_name: Laurent Guilleminault

given: Laurent

name: Département de Pneumologie et Addictologie Hôpital Arnaud de Villeneuve CHU Montpellier Montpellier France

family: Gamez

full_name: Anne‐Sophie Gamez

given: Anne‐Sophie

name: Service de Pneumologie Inserm CIC1401 CHU de Bordeaux Université de Bordeaux Bordeaux France

family: Berger

full_name: Patrick Berger

name: Département de Pathologie Thoracique CHU de Strasbourg Université de Strabsourg Strasbourg France

family: De Blay

full_name: Frédéric De Blay

name: Service de Pneumologie et Soins Intensifs Respiratoires Centre Hospitalo‐Universitaire de Dijon‐Bourgogne Dijon France

name: Faculté de Médecine et Pharmacie Université de Bourgogne‐Franche Comté Dijon France

family: Bonniaud

full_name: Philippe Bonniaud

given: Philippe

name: Département de Médecine Interne et Pneumologie Hôpital La Cavale Blanche Brest France

name: EA3878 Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO) Université Européenne de Bretagne Brest France

family: Leroyer

full_name: Christophe Leroyer

given: Christophe

name: Service de Pneumologie Oncologie Thoracique et Soins Intensifs Respiratoires CHU de Rouen Rouen France

family: Mahay

full_name: Guillaume Mahay

given: Guillaume

family: Girodet

full_name: Pierre‐Olivier Girodet

given: Pierre‐Olivier

family: Raherison

full_name: Chantal Raherison

given: Chantal

name: CHU Lille Service de Pneumologie et Immuno‐allergologie Institut Pasteur Lille Univ Lille Lille France

family: Fry

full_name: Stéphanie Fry

given: Stéphanie

name: Service de Pneumologie Hôpital Foch Suresnes France

family: Le Bourdellès

full_name: Geneviève Le Bourdellès

given: Geneviève

name: Service de Pneumologie CH de Nîmes Nîmes France

family: Proust

full_name: Alain Proust

name: Hôpital Tenon AP‐HP Département de Pneumologie et Réanimation Respiratoire Unité Fonctionnelle D’oncologie Thoracique Paris France

family: Rosencher

full_name: Lise Rosencher

given: Lise

name: Université Paris‐Sud and Université Paris‐Saclay Le Kremlin‐Bicêtre France

name: Service de Pneumologie AP‐ HP Hôpital Bicêtre Le Kremlin‐Bicêtre France

family: Garcia

full_name: Gilles Garcia

given: Gilles

family: Bourdin

full_name: Arnaud Bourdin

given: Arnaud

family: Chenivesse

full_name: Cécile Chenivesse

given: Cécile

family: Didier

full_name: Alain Didier

family: Couffignal

full_name: Camille Couffignal

given: Camille

family: Taillé

full_name: Camille Taillé

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical & Experimental Allergy

oa_host_type: repository

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

host_type: repository

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

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

title: Effectiveness and safety of dupilumab for the treatment of severe asthma in a real‐life French multi‐centre adult cohort

location_facility: Bichat-Claude Bernard University Hospital


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.

family: Wargny

full_name: Matthieu Wargny

given: Matthieu

family: Gallini

full_name: Adeline Gallini

given: Adeline

family: Hanaire

full_name: Hélène Hanaire

given: Hélène

family: Nourhashemi

full_name: Fati Nourhashemi

given: Fati

family: Andrieu

full_name: Sandrine Andrieu

given: Sandrine

family: Gardette

full_name: Virginie Gardette

given: Virginie

journal_name: Journal of the American Medical Directors Association

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: University Hospital, Toulouse


type: Other Identifier

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.

status: Unknown status

primary_purpose: Prevention

lead_sponsor: Centre Oscar Lambret

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


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: Hotel Dieu Hospital, Dermatologic Clinic

location_facility: Private Practice 2, Chalons-en-Champagne

location_facility: Private Practice, La Varenne Saint Hilaire

location_facility: Emile Durkheim Hospital - Saint Jean Health Center

intervention_type: Drug


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


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


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.

time_perspective: Other

lead_sponsor: University Hospital, Caen

location_facility: University Hospital Centre of Saint-Etienne


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.

family: Al-Gobari

full_name: Muaamar Al-Gobari

given: Muaamar

family: Agrinier

full_name: Nelly Agrinier

given: Nelly

family: Soudant

full_name: Marc Soudant

given: Marc

family: Burnand

full_name: Bernard Burnand

given: Bernard

family: Thilly

full_name: Nathalie Thilly

given: Nathalie

journal_name: American Journal of Cardiovascular Drugs

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

license_normalized: no license

repository_institution: reroDoc Digital Library

version: submittedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer


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.

study_start_date_type: Anticipated

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hopitaux de Marseille


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


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
Reserach Site
research Site


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

time_perspective: Cross-Sectional

ipd_sharing: Undecided

lead_sponsor: University Hospital, Montpellier


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

status: Terminated

primary_purpose: Supportive Care

ReferenceType: background

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.

family: Temel

full_name: Jennifer S. Temel

given: Jennifer S.

family: Greer

full_name: Joseph A. Greer

given: Joseph A.

family: Muzikansky

full_name: Alona Muzikansky

given: Alona

family: Gallagher

full_name: Emily R. Gallagher

given: Emily R.

family: Admane

full_name: Sonal Admane

given: Sonal

family: Jackson

full_name: Vicki A. Jackson

given: Vicki A.

family: Dahlin

full_name: Constance M. Dahlin

given: Constance M.

family: Blinderman

full_name: Craig D. Blinderman

given: Craig D.

family: Jacobsen

full_name: Juliet Jacobsen

given: Juliet

family: Pirl

full_name: William F. Pirl

given: William F.

family: Billings

full_name: J. Andrew Billings

given: J. Andrew

family: Lynch

full_name: Thomas J. Lynch

given: Thomas J.

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Early Palliative Care for Patients with Metastatic Non–Small-Cell Lung Cancer

lead_sponsor: University Hospital, Lille


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


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

intervention_type: Device


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: Weber M, Kodjikian L, Coscas F, Faure C, Aubry I, Dufour I, Cohen SY. Impact of intravitreal aflibercept dosing regimens in treatment-naïve 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.

family: Weber

full_name: Michel Weber

given: Michel

family: Kodjikian

full_name: Laurent Kodjikian

given: Laurent

family: Coscas

full_name: Florence Coscas

given: Florence

family: Faure

full_name: Céline Faure

given: Céline

family: Aubry

full_name: Isabelle Aubry

given: Isabelle

family: Dufour

full_name: Ingrid Dufour

given: Ingrid

family: Cohen

full_name: Salomon Y Cohen

given: Salomon Y

currency_apc_doaj: GBP

journal_name: BMJ Open Ophthalmology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: 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-naïve 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.

family: Dominguez

full_name: Marcel Dominguez

given: Marcel

family: Baillif

full_name: Stéphanie Baillif

given: Stéphanie

full_name: Salomon-Yves Cohen

given: Salomon-Yves

ReferenceCitation: Weber M, Velasque L, Coscas F, Faure C, Aubry I, Cohen SY. 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.


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: 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 Brest
CHU Rennes


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: 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: Roué 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.

name: Brest University Hospital, Pediatrics Department, Brest, France

name: Brest University, Faculty of Medicine, Brest, France

family: Roué

full_name: Jean-Michel Roué

given: Jean-Michel

name: Brest University Hospital, Clinical Investigation Center, INSERM 0502, Brest, France

family: Nowak

full_name: Emmanuel Nowak

given: Emmanuel

family: Le Gal

full_name: Grégoire Le Gal

given: Grégoire

family: Lemaitre

full_name: Thomas Lemaitre

given: Thomas

name: Rennes 1 University, Pharmacology Department, Rennes, France

family: Oger

full_name: Emmanuel Oger

family: Poulhazan

full_name: Elise Poulhazan

given: Elise

family: Giroux

full_name: Jean-Dominique Giroux

given: Jean-Dominique

family: Garenne

full_name: Armelle Garenne

given: Armelle

name: Sherbrooke University Hospital, Pediatrics Department, Sherbrooke, Quebec, Canada

family: Gagneur

full_name: Arnaud Gagneur

given: Arnaud

journal_name: Clinical and Vaccine Immunology

evidence: open (via free pdf)

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

title: Impact of Rotavirus Vaccine on Premature Infants

ReferenceCitation: Gagneur A, Nowak E, Lemaitre T, Segura JF, Delaperrière 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.

family: Segura

full_name: Jean-Francois Segura

given: Jean-Francois

family: Delaperrière

full_name: Nadège Delaperrière

given: Nadège

family: Abalea

full_name: Lydie Abalea

given: Lydie

family: Jossens

full_name: Anne Jossens

title: Impact of rotavirus vaccination on hospitalizations for rotavirus diarrhea: The IVANHOE study


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.

status: Active, not recruiting

ipd_sharing_description: NC


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: 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.


type: EudraCT Number

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.

primary_purpose: Treatment

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


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: 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.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Centre Hospitalier Intercommunal St. Aubin les Elbeuf


title: Staff Opinions and Knowledge Concerning Organ and Tissue Harvesting: an Investigation Among the Patient Care Personnel in the South-Mediterranean Region of France

summary: The goal of this study is to evaluate the knowledge of paramedical and medical care personnel concerning organ and tissue donations, as well as their opinions on this activity.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Hôpital Guy de Chauliac, CHU de Montpellier


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.

ReferenceCitation: Frable DE, Wortman C, Joseph J. Predicting self-esteem, well-being, and distress in a cohort of gay men: the importance of cultural stigma, personal visibility, community networks, and positive identity. J Pers. 1997 Sep;65(3):599-624.

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. Review.

lead_sponsor: Centre Hospitalier St Anne

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


title: Outcome of Cardiac Arrest Survivors: Prospective Cohort of Ile-de-France

acronym: DESAC

summary:
Early prognosis of cardiac arrest - nearly 40000 new cases per year in France - has been extensively studied, highlighting a poor outcome (less than 8% at hospital discharge). However, little is known on mid and long-term prognostic factors and how these patients do survive from the event.

Using a regional cohort, the aim of the study is to describe long-term survival rate of cardiac arrest survivors, and to assess the influence of treatment strategies on survival and functional outcome.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: INSERM U970 Centre de Recherche Cardiovasculaire de Paris Equipe 4, Epidémiologie Cardiovasculaire et Mort Subite


title: Prospective Study of the Diagnostic and Therapeutic Management of Congenital Glaucoma in France

acronym: Conglau

summary:
Evidence of a relationship between age at discovery of congenital glaucoma and visual acuity at 4 years of age.

The delay in diagnosis is a factor of poor visual acuity. Will justify the implementation of information programs with health and education professionals in order to improve the functional prognosis of patients with congenital glaucoma.

location_facility: Hu Necker Enfants Malades Aphp - Paris 15

location_facility: Hopital Civil / Nouvel Hopital Civil - Strasbourg

intervention_type: Procedure


title: A Pan-European Non-interventional, Retrospective Observational Cohort Study of Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Treated With Olaparib Tablets in the First-line Maintenance Setting

summary: This is a retrospective observational medical records review study of BRCA mutated advanced (FIGO stage III-IV) ovarian cancer patients who received first dose maintenance olaparib in 1L setting in France, Italy and the UK. Physicians who treated ovarian cancer patients with olaparib in 1L setting will be requested to recruit patients to have their clinical data abstracted from their clinical records in line with local laws

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: AstraZeneca

location_country:
United Kingdom
France


title: Strategic Screening for Infectious Diseases (Tuberculosis, HIV, HBV, HCV) Amongst Migrants in France

acronym: STRADA

summary: To evaluate the efficacy of a new screening for infectious diseases: tuberculosis, HIV, HBV and HCV, based on risk factors questionnaires (TB screen for tuberculosis and TROD screen for HIV and hepatitis) amongst a population of legal migrants during their mandatory medical check-up. This study aims for a global improvement of screening and care for migrants.

ReferenceCitation: Meffre C, Le Strat Y, Delarocque-Astagneau E, Dubois F, Antona D, Lemasson JM, Warszawski J, Steinmetz J, Coste D, Meyer JF, Leiser S, Giordanella JP, Gueguen R, Desenclos JC. Prevalence of hepatitis B and hepatitis C virus infections in France in 2004: social factors are important predictors after adjusting for known risk factors. J Med Virol. 2010 Apr;82(4):546-55. doi: 10.1002/jmv.21734.

ReferenceCitation: Schneeberger Geisler S, Helbling P, Zellweger JP, Altpeter ES. Screening for tuberculosis in asylum seekers: comparison of chest radiography with an interview-based system. Int J Tuberc Lung Dis. 2010 Nov;14(11):1388-94.

ReferenceCitation: d'Almeida KW, Kierzek G, de Truchis P, Le Vu S, Pateron D, Renaud B, Semaille C, Bousquet V, Simon F, Guillemot D, Lert F, Crémieux AC; Emergency Department HIV-Screening Group. Modest public health impact of nontargeted human immunodeficiency virus screening in 29 emergency departments. Arch Intern Med. 2012 Jan 9;172(1):12-20. doi: 10.1001/archinternmed.2011.535. Epub 2011 Oct 24.

ReferenceCitation: d'Almeida KW, Pateron D, Kierzek G, Renaud B, Semaille C, de Truchis P, Simon F, Leblanc J, Lert F, Le Vu S, Crémieux AC. Understanding providers' offering and patients' acceptance of HIV screening in emergency departments: a multilevel analysis. ANRS 95008, Paris, France. PLoS One. 2013 Apr 29;8(4):e62686. doi: 10.1371/journal.pone.0062686. Print 2013.

ReferenceCitation: Bottero J, Boyd A, Gozlan J, Carrat F, Nau J, Pauti MD, Rougier H, Girard PM, Lacombe K. Simultaneous Human Immunodeficiency Virus-Hepatitis B-Hepatitis C Point-of-Care Tests Improve Outcomes in Linkage-to-Care: Results of a Randomized Control Trial in Persons Without Healthcare Coverage. Open Forum Infect Dis. 2015 Oct 26;2(4):ofv162. doi: 10.1093/ofid/ofv162. eCollection 2015 Dec.

name: Sorbonne Universités, Université Pierre-et-Marie-Curie Paris 06, Institut National de la Sante et de la Recherche Medicale (INSERM), Institut Pierre Louis d’Épidémiologie et de Santé Publique

name: Service de Maladies Infectieuses, Centre Hospitalier Universitaire (CHU) St. Antoine

family: Bottero

full_name: Julie Bottero

given: Julie

family: Boyd

full_name: Anders Boyd

given: Anders

name: Laboratoire de Virologie, CHU St. Antoine

name: INSERM U1135 Centre d'Immunologie et des Maladies Infectieuses

family: Gozlan

full_name: Joel Gozlan

given: Joel

name: Département de Santé Publique, Hôpital St-Antoine, Assistance Publique-Hôpitaux de Paris

family: Carrat

full_name: Fabrice Carrat

given: Fabrice

name: Médecins du Monde, Centre d'Accueil de Soins et d'Orientation

family: Nau

full_name: Jean Nau

given: Jean

name: Médecins du Monde, Direction des Missions France, Paris, France

family: Pauti

full_name: Marie-Dominique Pauti

given: Marie-Dominique

family: Rougier

full_name: Hayette Rougier

given: Hayette

family: Girard

full_name: Pierre-Marie Girard

given: Pierre-Marie

family: Lacombe

full_name: Karine Lacombe

given: Karine

currency_apc_doaj: USD

journal_name: Open Forum Infectious Diseases

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (semantic scholar lookup)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Haukoos JS, Lyons MS, Lindsell CJ, Hopkins E, Bender B, Rothman RE, Hsieh YH, Maclaren LA, Thrun MW, Sasson C, Byyny RL. Derivation and validation of the Denver Human Immunodeficiency Virus (HIV) risk score for targeted HIV screening. Am J Epidemiol. 2012 Apr 15;175(8):838-46. doi: 10.1093/aje/kwr389. Epub 2012 Mar 19.

lead_sponsor: University Paris 7 - Denis Diderot

location_facility:
OFII Grenoble
OFII Rouen
OFII Bordeaux
OFII Cergy
OFII Lille
OFII Montrouge
OFII Toulouse
OFII Nice
OFII Metz
OFII Reims
OFII Clermont-Ferrand
OFII Melun
OFII Montpellier
OFII Rennes
OFII Marseille
OFII Orléans
OFII Nantes
OFII Lyon


title: A Prospective, Observational, Monocentre 5-year Follow-up Clinical Trial on a Historical Consecutive Cohort of Unicompartmental Knee Arthroplasty Patients Treated With the Mobile Bearing Unicondylar Knee Prosthesis Univation XM

summary:
The study is set up due to regulatory purposes and to collect routine clinical data of the mobile-bearing implant univation XM. The study is designed as a prospective follow-up study with a historic patient cohort who have been treated with the product under investigation two years ago. This design is selected to quicker realize follow-up data as patients have already been treated in the past.

As the mobile version of the implant is not widely used, the study will be set up as a monocentric study in France. The clinical hypothesis of the study is that patients who are treated with the product under investigation have a similar outcome and survival rate in comparison to other established unicondylar knee systems on the market. Comparison for the later evaluation will be taken out of recent orthopaedic registries.

status: Withdrawn

lead_sponsor: Aesculap AG


title: Prevalence of Clinical Strains of Enterobacteria With Reduced Susceptibility to Carbapenems in the North-West Region of France

acronym: ERC

summary:
Enterobacteria constitute a family of Gram negative bacilli of the gastrointestinal flora. These micro-organisms are frequently responsible for nosocomial or community-acquired infections, for which treatment is essentially based on the use of beta-lactam antibiotics. This class of antibiotics comprises penicillins, cephalosporins, monobactams and carbapenems. Carbapenems have the advantage of possessing a broad antibacterial spectrum and the capacity to resist the hydrolytic action of a large number of beta-lactamases, widespread inactivating enzymes.

However, new enzymes, called carbapenemases, able to confer resistance to carbapenems either alone or in combination with additional resistance mechanisms such as loss of membrane permeability or overexpression of efflux systems, are currently emerging all over the world. Carbapenemases represent a major public health problem because of the risk of therapeutic impasse and their high epidemic potential.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHRU Lille
CHU Caen
CHU Amiens
CH Beauvais
CH Abbeville
CHU Compiegne


title: Cohort of Patients Infected With SARS-CoV2 or Suspected of Being (COVID-19 in Ile-de-France)

acronym: COVIDeF

summary:
On 17th March 2020, 198 193 confirmed cases (7 730 in France) of COVID-19 infections and 7 854 deaths (175 in France) have been reported from 8th December 2019 in 157 countries. The rapid increase in cases on french territory has led to the transition of France to level 3 of the epidemic on 14th March 2020.

The natural history of the disease is still poorly understood, especially prognostic factors, which are crucial for the best medical care of patients in times of epidemics, when hospital capacities are under pressure.

A better knowledge of natural history, of prognostic factors, the development and validation of new diagnostic tests, the evaluation of medical care, will lead to a better medical care of patients infected with COVID-19.

design_allocation: Non-Randomized

primary_purpose: Basic Science

location_facility: GH Pitié-Salpêtrière / Service d'Accueil des Urgences


title: Efficient Treatments for ACE-I and ARB-induced Angioedema Exist and Should be Available to All Patients. Analysis of Their Availability and Influencing Factors in the Area Around Lyon, France

summary: Specific treatments for angiotensin-converting-enzyme inhibitor (ACE-I) and angiotensin-receptor-blocker (ARB)-induced angioedema exist. Early access to these treatments is challenging because they are expensive and have short shelf lives making it illusory that all emergency department (ED) stock them. The aim of this retrospective study was to define, for each patient with a confirmed ACE-I or ARB-induced angioedema, at which step of the care, the specific treatment was administered. The second objective was to analyse the availability of these treatment in the area around Lyon, France and the factors that may influence it.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon, Département d'Anesthésie-Réanimation, Hôpital Edouard Herriot, Lyon, France.


title: A Multicentre, Randomised, Open-label, Active-controlled Trial of the Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France

acronym: RIME

summary:
Patients who admit to using buprenorphine by the intravenous route will be randomized to either Subutex or Suboxone and be followed up for 3 months to determine if there is less injection with Suboxone than with Subutex based primarily on patient diaries.

Patients randomized to Suboxone may continue to receive the product for a further 9 months at their request and will be monitored at 3 month intervals.

Patients will receive a payment for the inconvenience of keeping a daily diary and to cover their travel expenses.

lead_sponsor: Indivior Inc.

location_facility: CSST Centre Port Bretagne CH Charles Perrens

location_facility: CHU de Clermont-Ferrand, Centre Méthadone

location_facility: Centre Hospitalier Esquirol - Intersecteur, Regional Soins en Addictologie


title: DIVERSITY OF BORRELIA SPECIES INVOLVED IN CUTANEOUS MANIFESTATIONS OF LYME BORRELIOSIS IN FRANCE

summary: The aim of this study is to identify the species of Borrelia involved in the dermatologic manifestations of Lyme borreliosis in France. Indeed, in Europe, as opposed to North America, many bacterial species are involved in Lyme borreliosis. Yet, very few is known about the prevalence and distribution of different bacteriological species that account for the disease in France. Thus, this a nation-wide study in which all French dermatologists are invited to participate. Every adult patient presenting with one of the cutaneous manifestation of Lyme borreliosis: erythema migrans, lymphocytoma or acrodermatitis chronica atrophicans can be included in the study. If the patient agrees participating, after information and written consent, a cutaneous biopsy will be performed in order to isolate Borrelia by means of culture and PCR. An estimated 400 biopsies should be performed within 2 years.

location_facility: Service des Maladies infectieuses et tropicales, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg


title: A 24-month Prospective, Non-interventional, Multicentre Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France

acronym: B-SURE

summary: Alprolix (rFIXFc) is a recombinant extended half-life coagulation factor product. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Alprolix in the on-demand and prophylactic treatment of haemophilia B.

lead_sponsor: Swedish Orphan Biovitrum

location_facility:
Swedish Orphan Biovitrum Research Site
Swedish Orphan Biovitrum research site


title: Prospective Registry in Young Women Presenting Acute Myocardial Infarction in France: Clinical, Morphological and Biological Descriptive Analysis: WAMIF Study

acronym: WAMIF

summary:
MI in elderly women seems to share the same pathophysiology than in men, especially plaque rupture associated with conventional risk factors. Therefore the questions is not solved on the pathophysiology and specific risk factors in young women whose prognosis is more severe. A complete descriptive analysis appears mandatory to understand the peculiarities, including not only morphological but also biological explorations as well.

To date no systematic descriptive analysis has been performed including clinical characteristics, cardiac and extra-cardiac morphological exploration and hormonal and immunological assays, particularly in young premenopausal women presenting MI.

This study will provide for the first time a complete analysis, including hormonal assays, never made in an "acute" population.

The main objective of this clinical study is to systematically pool clinical, morphological and biological data of young women (< 50 years) presenting an Acute MI and to assess their short-term (in-hospital) and mid-term (12 months) prognosis. The definition of MI is the one adopted in the Third definition published in 2012. As such an event occurs in a young patient, diagnostic and treatment may vary among centres. The incidence of such cases in each centre being low and practice inhomogeneous, no conclusion could be advanced concerning the study of associated, indeed predisposing factors.

The work aims to comprehensively and systematically collect all the clinical and laboratory data and the results of the all morphological explorations carried out during the care of these young women admitted for acute MI in high-volume centres.

No additional invasive act, without any direct benefit for the care of patients will be realized for research purposes.

All these examinations, in particular invasive morphological, are more and more integrated in the practice of modern interventional cardiology especially for complex or infrequent situations, like this setting. They afford accurate diagnosis of coronary disease on one hand and on the second hand they determine the causal or at least participating factor.

A comprehensive and systematic analysis of this particular entity that is MI in young woman, would improve our knowledge of this disease and then enable to offer patients a more appropriate treatment and monitoring. It is necessary to progress in the understanding of the mechanisms of the early onset of coronary artery disease in its most acute and most serious presentation and to clearly define the specificities of coronary disease in young women. Moreover, a more precise identification of risk factors of MI in a woman under 50 will allow a better screening and even introduction of preventive strategies.

lead_sponsor: French Cardiology Society

location_facility: Centre Hospitalier D'Antibes Juan-Les-Pins


title: Reorganization of Care in Patients Hospitalized in Child Psychiatry for Anorexia Nervosa at the Time of the Coronavirus-19 Epidemic in France: Qualitative Study Carried Out on Patients and Their Parents

acronym: QUALICOVID

summary:
Anorexia nervosa is a severe psychiatric condition. On the nutritional level, one of the objectives recommended by the High Authority of Health is to "achieve and maintain an appropriate weight and nutritional status". It is recommended that, in the event of hospitalisation, this should be "as long as necessary" and be based on a weight contract as a condition for discharge. Within the Pôle Universitaire de Psychiatrie de l'Enfant et de l'Adolescent of the Centre Psychothérapique de Nancy, an inpatient unit takes care of children and adolescents with a specific valence in the management of patients suffering from eating disorders.

Since the first quarter of 2020, France has been progressively affected by the pandemic of the coronavirus 2019, Covid-19. This pandemic has led to unprecedented containment measures in France and around the world.

At the time of the announcement of the implementation of containment, the investigators proposed to the parents of patients hospitalized in the Child and Adolescent Psychiatry Department of the Nancy Psychotherapy Center who were approaching their discharge weight to be able to end their hospitalization prematurely. As a follow-up to this hospitalisation, intensive outpatient care was offered to the families, in accordance with State recommendations in connection with the pandemic. In this hospitalized unit, weekly outpatient consultations were maintained and coupled with telephone interviews, teleconsultation interviews and a telephone hotline for the healthcare team.

The objective of the study is to explore, in a qualitative way, the experiences of patients hospitalized in the child psychiatry department for anorexia nervosa at the time of the coronavirus epidemic in France and those of their parents, in relation to the reorganization of care.

lead_sponsor: Centre Psychothérapique de Nancy


title: Description of Pneumococcal Community-acquired Pneumonia in General Practice in France

acronym: PneumoCAP

summary:
Statement of the problem:

Overprescription of antibiotics raises important public health issues because of the emergence of multiresistant bacteria by selection pressure. The results of the observational prospective study entitled "CAPA" on the description of 886 suspected cases of acute community-acquired pneumonia (CAP) treated in general practices in France confirm that, whatever the etiologic hypothesis and the results of the chest X-ray, these patients routinely receive antibiotics. Therefore, it is important to be able to distinguish cases of pneumococcal CAP in which early antibiotic treatment is justified from those cases for which another strategy could be considered.

Primary objective:

To identify the clinical, biological and radiological characteristics of patients with pneumococcal CAP amongst all patients with CAP radiologically confirmed, in general practice in France.

Design :

Prospective cross-sectional descriptive study.

Inclusion criteria. Adults older than 18 showing clinical signs suggestive of CAP (at least one sign of infection and at least one pulmonary sign) and able to realize chest X ray within 6 hours after prescription.

Patient follow-up procedures. Patients will be treated by standard of care according to French recommendations. After observing clinical signs suggestive of CAP, the physician prescribes a chest X-ray. Then, protocol-specific examinations (blood sample, oropharyngeal sample for multiplex polymerase chain reaction (PCR), sputum sample testing (induced expectoration if possible), urinary sample) will be performed on all out patients. Patients will be contacted again on day 28 to increase diagnostic certainty. For patients with clinical signs of CAP and hospitalized, the investigator will ask their consent to retrieve the hospital report, on or before day 28 and to be contacted on day 90.

ReferenceCitation: Hosker H, Cooke NJ, Hawkey P. Antibiotics in chronic obstructive pulmonary disease. BMJ. 1994 Apr 2;308(6933):871-2.

ReferenceCitation: Wipf JE, Lipsky BA, Hirschmann JV, Boyko EJ, Takasugi J, Peugeot RL, Davis CL. Diagnosing pneumonia by physical examination: relevant or relic? Arch Intern Med. 1999 May 24;159(10):1082-7.

ReferenceCitation: Jackson ML, Neuzil KM, Thompson WW, Shay DK, Yu O, Hanson CA, Jackson LA. The burden of community-acquired pneumonia in seniors: results of a population-based study. Clin Infect Dis. 2004 Dec 1;39(11):1642-50. Epub 2004 Nov 8.

ReferenceCitation: Holm A, Nexoe J, Bistrup LA, Pedersen SS, Obel N, Nielsen LP, Pedersen C. Aetiology and prediction of pneumonia in lower respiratory tract infection in primary care. Br J Gen Pract. 2007 Jul;57(540):547-54.

ReferenceCitation: Porath A, Schlaeffer F, Lieberman D. The epidemiology of community-acquired pneumonia among hospitalized adults. J Infect. 1997 Jan;34(1):41-8.

ReferenceCitation: Said MA, Johnson HL, Nonyane BA, Deloria-Knoll M, O'Brien KL; AGEDD Adult Pneumococcal Burden Study Team, Andreo F, Beovic B, Blanco S, Boersma WG, Boulware DR, Butler JC, Carratalà J, Chang FY, Charles PG, Diaz AA, Domínguez J, Ehara N, Endeman H, Falcó V, Falguera M, Fukushima K, Garcia-Vidal C, Genne D, Guchev IA, Gutierrez F, Hernes SS, Hoepelman AI, Hohenthal U, Johansson N, Kolek V, Kozlov RS, Lauderdale TL, Mareković I, Masiá M, Matta MA, Miró Ò, Murdoch DR, Nuermberger E, Paolini R, Perelló R, Snijders D, Plečko V, Sordé R, Strålin K, van der Eerden MM, Vila-Corcoles A, Watt JP. Estimating the burden of pneumococcal pneumonia among adults: a systematic review and meta-analysis of diagnostic techniques. PLoS One. 2013;8(4):e60273. doi: 10.1371/journal.pone.0060273. Epub 2013 Apr 2. Review.

ReferenceCitation: Musher DM, Thorner AR. Community-acquired pneumonia. N Engl J Med. 2014 Oct 23;371(17):1619-28. doi: 10.1056/NEJMra1312885. Review.

ReferenceCitation: Dorca J, Torres A. Lower respiratory tract infections in the community: towards a more rational approach. Eur Respir J. 1996 Aug;9(8):1588-9. Review.

ReferenceCitation: Gennis P, Gallagher J, Falvo C, Baker S, Than W. Clinical criteria for the detection of pneumonia in adults: guidelines for ordering chest roentgenograms in the emergency department. J Emerg Med. 1989 May-Jun;7(3):263-8.

ReferenceCitation: Metlay JP, Fine MJ. Testing strategies in the initial management of patients with community-acquired pneumonia. Ann Intern Med. 2003 Jan 21;138(2):109-18. Review.

ReferenceCitation: Partouche H, Buffel du Vaure C, Personne V, Le Cossec C, Garcin C, Lorenzo A, Ghasarossian C, Landais P, Toubiana L, Gilberg S. Suspected community-acquired pneumonia in an ambulatory setting (CAPA): a French prospective observational cohort study in general practice. NPJ Prim Care Respir Med. 2015 Mar 12;25:15010. doi: 10.1038/npjpcrm.2015.10.

ReferenceCitation: Young M, Marrie TJ. Interobserver variability in the interpretation of chest roentgenograms of patients with possible pneumonia. Arch Intern Med. 1994 Dec 12-26;154(23):2729-32.

ReferenceCitation: Claessens YE, Debray MP, Tubach F, Brun AL, Rammaert B, Hausfater P, Naccache JM, Ray P, Choquet C, Carette MF, Mayaud C, Leport C, Duval X. Early Chest Computed Tomography Scan to Assist Diagnosis and Guide Treatment Decision for Suspected Community-acquired Pneumonia. Am J Respir Crit Care Med. 2015 Oct 15;192(8):974-82. doi: 10.1164/rccm.201501-0017OC.

family: Claessens

full_name: Yann-Erick Claessens

given: Yann-Erick

family: Debray

full_name: Marie-Pierre Debray

given: Marie-Pierre

family: Tubach

full_name: Florence Tubach

given: Florence

family: Brun

full_name: Anne-Laure Brun

given: Anne-Laure

family: Rammaert

full_name: Blandine Rammaert

given: Blandine

family: Hausfater

full_name: Pierre Hausfater

given: Pierre

family: Naccache

full_name: Jean-Marc Naccache

given: Jean-Marc

family: Ray

full_name: Patrick Ray

given: Patrick

family: Choquet

full_name: Christophe Choquet

given: Christophe

family: Carette

full_name: Marie-France Carette

given: Marie-France

family: Mayaud

full_name: Charles Mayaud

given: Charles

family: Leport

full_name: Catherine Leport

given: Catherine

family: Duval

full_name: Xavier Duval

given: Xavier

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

ReferenceCitation: Ortqvist A, Hedlund J, Wretlind B, Carlström A, Kalin M. Diagnostic and prognostic value of interleukin-6 and C-reactive protein in community-acquired pneumonia. Scand J Infect Dis. 1995;27(5):457-62.

ReferenceCitation: Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Müller B. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet. 2004 Feb 21;363(9409):600-7.

ReferenceCitation: Le Bel J, Hausfater P, Chenevier-Gobeaux C, Blanc FX, Benjoar M, Ficko C, Ray P, Choquet C, Duval X, Claessens YE; ESCAPED study group. Diagnostic accuracy of C-reactive protein and procalcitonin in suspected community-acquired pneumonia adults visiting emergency department and having a systematic thoracic CT scan. Crit Care. 2015 Oct 16;19:366. doi: 10.1186/s13054-015-1083-6.

apc_source: openAPC

family: Le Bel

full_name: Josselin Le Bel

given: Josselin

family: Chenevier-Gobeaux

full_name: Camille Chenevier-Gobeaux

given: Camille

family: Blanc

full_name: François-Xavier Blanc

given: François-Xavier

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

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

ReferenceCitation: van Vugt SF, Broekhuizen BD, Lammens C, Zuithoff NP, de Jong PA, Coenen S, Ieven M, Butler CC, Goossens H, Little P, Verheij TJ; GRACE consortium. Use of serum C reactive protein and procalcitonin concentrations in addition to symptoms and signs to predict pneumonia in patients presenting to primary care with acute cough: diagnostic study. BMJ. 2013 Apr 30;346:f2450. doi: 10.1136/bmj.f2450.

ReferenceCitation: van der Meer V, Neven AK, van den Broek PJ, Assendelft WJ. Diagnostic value of C reactive protein in infections of the lower respiratory tract: systematic review. BMJ. 2005 Jul 2;331(7507):26. Epub 2005 Jun 24. Review.

ReferenceCitation: Holm A, Pedersen SS, Nexoe J, Obel N, Nielsen LP, Koldkjaer O, Pedersen C. Procalcitonin versus C-reactive protein for predicting pneumonia in adults with lower respiratory tract infection in primary care. Br J Gen Pract. 2007 Jul;57(540):555-60.

ReferenceCitation: Niederman MS. Biological markers to determine eligibility in trials for community-acquired pneumonia: a focus on procalcitonin. Clin Infect Dis. 2008 Dec 1;47 Suppl 3:S127-32. doi: 10.1086/591393. Review.

ReferenceCitation: Melbye H, Stocks N. Point of care testing for C-reactive protein - a new path for Australian GPs? Aust Fam Physician. 2006 Jul;35(7):513-7. Review.

ReferenceCitation: Christ-Crain M, Müller B. Procalcitonin and pneumonia: is it a useful marker? Curr Infect Dis Rep. 2007 May;9(3):233-40.

ReferenceCitation: Rosón B, Fernández-Sabé N, Carratalà J, Verdaguer R, Dorca J, Manresa F, Gudiol F. Contribution of a urinary antigen assay (Binax NOW) to the early diagnosis of pneumococcal pneumonia. Clin Infect Dis. 2004 Jan 15;38(2):222-6. Epub 2003 Dec 18.

ReferenceCitation: Guchev IA, Yu VL, Sinopalnikov A, Klochkov OI, Kozlov RS, Stratchounski LS. Management of nonsevere pneumonia in military trainees with the urinary antigen test for Streptococcus pneumoniae: an innovative approach to targeted therapy. Clin Infect Dis. 2005 Jun 1;40(11):1608-16. Epub 2005 May 2. Erratum in: Clin Infect Dis. 2005 Aug 15;41(4):580-1.

ReferenceCitation: Song JY, Eun BW, Nahm MH. Diagnosis of pneumococcal pneumonia: current pitfalls and the way forward. Infect Chemother. 2013 Dec;45(4):351-66. doi: 10.3947/ic.2013.45.4.351. Epub 2013 Dec 27. Review.

ReferenceCitation: Pride MW, Huijts SM, Wu K, Souza V, Passador S, Tinder C, Song E, Elfassy A, McNeil L, Menton R, French R, Callahan J, Webber C, Gruber WC, Bonten MJ, Jansen KU. Validation of an immunodiagnostic assay for detection of 13 Streptococcus pneumoniae serotype-specific polysaccharides in human urine. Clin Vaccine Immunol. 2012 Aug;19(8):1131-41. doi: 10.1128/CVI.00064-12. Epub 2012 Jun 6.

ReferenceCitation: Reddington K, Tuite N, Barry T, O'Grady J, Zumla A. Advances in multiparametric molecular diagnostics technologies for respiratory tract infections. Curr Opin Pulm Med. 2013 May;19(3):298-304. doi: 10.1097/MCP.0b013e32835f1b32. Review.

ReferenceCitation: Jain S, Self WH, Wunderink RG, Fakhran S, Balk R, Bramley AM, Reed C, Grijalva CG, Anderson EJ, Courtney DM, Chappell JD, Qi C, Hart EM, Carroll F, Trabue C, Donnelly HK, Williams DJ, Zhu Y, Arnold SR, Ampofo K, Waterer GW, Levine M, Lindstrom S, Winchell JM, Katz JM, Erdman D, Schneider E, Hicks LA, McCullers JA, Pavia AT, Edwards KM, Finelli L; CDC EPIC Study Team. Community-Acquired Pneumonia Requiring Hospitalization among U.S. Adults. N Engl J Med. 2015 Jul 30;373(5):415-27. doi: 10.1056/NEJMoa1500245. Epub 2015 Jul 14.

ReferenceCitation: Houck PM, Bratzler DW, Nsa W, Ma A, Bartlett JG. Timing of antibiotic administration and outcomes for Medicare patients hospitalized with community-acquired pneumonia. Arch Intern Med. 2004 Mar 22;164(6):637-44.

ReferenceCitation: Flamaing J, De Backer W, Van Laethem Y, Heijmans S, Mignon A. Pneumococcal lower respiratory tract infections in adults: an observational case-control study in primary care in Belgium. BMC Fam Pract. 2015 May 27;16:66. doi: 10.1186/s12875-015-0282-1. Erratum in: BMC Fam Pract. 2016;17:25.


title: Benefits of a Long Term Implantable Continuous Glucose Monitoring System for Adults With Diabetes - France Randomized Clinical Trial

summary: This study will be conducted in France and will evaluate the usefulness of using a long-term subcutaneously inserted continuous glucose monitoring (CGM) sensor (the Eversense XL CGM System) to improve glycemic control in patients with either Type 1 or Type 2 diabetes mellitus under insulin therapy. Participants will be enrolled into one of two cohorts (Cohorts 1 and 2). Cohort 1 will be focused on participants with Type 1 or Type 2 diabetes with hemoglobin A1C (HbA1c) >8%. Cohort 2 will be focused on participants with Type 1 diabetes spending more than 1.5 hours per day with mean glucose <70 mg/dL, including excursions below 54 mg/dL, for at least 28 days. Within each cohort, participants will be randomized in a 2:1 ratio to one of two groups: the Enabled and Control groups, respectively. The Enabled group will be trained to use the CGM system, whereas the Control group will continue with their usual glucose monitoring system (self-monitoring of blood glucose [SMBG] or flash glucose monitoring [FGM]).

primary_purpose: Diagnostic

location_facility: Institut de diabétologie et Nutrition du Centre