title: French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS

acronym: FRANCE-ABSORB

summary:
Observational Study, French, prospective, multicenter rated using intravascular prosthesis ABSORB BVS.

ABSORB BVS is a prosthesis of a new type. This study will prospectively evaluate all procedures for coronary angioplasty with implantation of at least one BVS with a clinical follow-up of all patients implanted with ABSORB BVS. This national observatory will collect all the events related to product and / or to procedure

ReferenceCitation: Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6.

ReferenceCitation: Grüntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979 Jul 12;301(2):61-8.

ReferenceCitation: Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95.

ReferenceCitation: Serruys PW, Kutryk MJ, Ong AT. Coronary-artery stents. N Engl J Med. 2006 Feb 2;354(5):483-95. Review.

ReferenceCitation: Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnàr F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80.

ReferenceCitation: Abbott JD, Voss MR, Nakamura M, Cohen HA, Selzer F, Kip KE, Vlachos HA, Wilensky RL, Williams DO. Unrestricted use of drug-eluting stents compared with bare-metal stents in routine clinical practice: findings from the National Heart, Lung, and Blood Institute Dynamic Registry. J Am Coll Cardiol. 2007 Nov 20;50(21):2029-36.

ReferenceCitation: Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008 Mar 15;371(9616):899-907. doi: 10.1016/S0140-6736(08)60415-8.

ReferenceCitation: Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hébert K, Veldhof S, Webster M, Thuesen L, Dudek D. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009 Mar 14;373(9667):897-910. doi: 10.1016/S0140-6736(09)60325-1.

ReferenceCitation: Serruys PW, Onuma Y, Ormiston JA, de Bruyne B, Regar E, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Miquel-Hebert K, Rapoza R, García-García HM. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes. Circulation. 2010 Nov 30;122(22):2301-12. doi: 10.1161/CIRCULATIONAHA.110.970772. Epub 2010 Nov 15.

name: From the ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands (P.W.S., Y.O., E.R., H.M.G.-G.); Cardiovascular Center, Aalst, Belgium (B.d.B.); Jagiellonian University, Krakow, Poland (D.D.); Skejby Sygehus, Aarhus University Hospital, Skejby, Denmark (L.T.); Maasstad Hospital, Rotterdam, the Netherlands (P.C.S.); Institut Jacques Cartier, Massy, France (B.C.); Christchurch Hospital, Christchurch, New Zealand (D.M.); Catharina Hospital, Eindhoven, the Netherlands (J.K.); Bern University...

family: Serruys

full_name: Patrick W. Serruys

given: Patrick W.

family: Onuma

full_name: Yoshinobu Onuma

given: Yoshinobu

family: Ormiston

full_name: John A. Ormiston

given: John A.

family: de Bruyne

full_name: Bernard de Bruyne

given: Bernard

family: Regar

full_name: Evelyn Regar

given: Evelyn

family: Dudek

full_name: Dariusz Dudek

given: Dariusz

family: Thuesen

full_name: Leif Thuesen

given: Leif

family: Smits

full_name: Pieter C. Smits

given: Pieter C.

family: Chevalier

full_name: Bernard Chevalier

family: McClean

full_name: Dougal McClean

given: Dougal

family: Koolen

full_name: Jacques Koolen

given: Jacques

family: Windecker

full_name: Stephan Windecker

given: Stephan

family: Whitbourn

full_name: Robert Whitbourn

given: Robert

family: Meredith

full_name: Ian Meredith

given: Ian

family: Dorange

full_name: Cécile Dorange

given: Cécile

family: Veldhof

full_name: Susan Veldhof

given: Susan

family: Miquel-Hebert

full_name: Karine Miquel-Hebert

given: Karine

family: Rapoza

full_name: Richard Rapoza

given: Richard

family: García-García

full_name: Hector M. García-García

given: Hector M.

journal_name: Circulation

oa_host_type: publisher

title: Evaluation of the Second Generation of a Bioresorbable Everolimus Drug-Eluting Vascular Scaffold for Treatment of De Novo Coronary Artery Stenosis

ReferenceCitation: Serruys PW, Onuma Y, Dudek D, Smits PC, Koolen J, Chevalier B, de Bruyne B, Thuesen L, McClean D, van Geuns RJ, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Sudhir K, Garcia-Garcia HM, Ormiston JA. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol. 2011 Oct 4;58(15):1578-88. doi: 10.1016/j.jacc.2011.05.050.

title: Evaluation of the Second Generation of a Bioresorbable Everolimus-Eluting Vascular Scaffold for the Treatment of De Novo Coronary Artery Stenosis

ReferenceCitation: Dudek D, Onuma Y, Ormiston JA, Thuesen L, Miquel-Hebert K, Serruys PW. Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2012 Jan;7(9):1060-1. doi: 10.4244/EIJV7I9A168.

ReferenceCitation: Ramcharitar S, Serruys PW. Fully biodegradable coronary stents : progress to date. Am J Cardiovasc Drugs. 2008;8(5):305-14. Review.

ReferenceCitation: Macaya C, Moreno R. Bioabsorbable drug-eluting stents: the future of coronary angioplasty? Nat Clin Pract Cardiovasc Med. 2008 Oct;5(10):598-9. doi: 10.1038/ncpcardio1306. Epub 2008 Aug 5.

ReferenceCitation: Colombo A, Sharp AS. The bioabsorbable stent as a virtual prosthesis. Lancet. 2009 Mar 14;373(9667):869-70. doi: 10.1016/S0140-6736(09)60521-3.

ReferenceCitation: Ormiston JA, Serruys PW. Bioabsorbable coronary stents. Circ Cardiovasc Interv. 2009 Jun;2(3):255-60. doi: 10.1161/CIRCINTERVENTIONS.109.859173. Review.

ReferenceCitation: Onuma Y, Piazza N, Ormiston JA, Serruys PW. Everolimus-eluting bioabsorbable stent--Abbot Vascular programme. EuroIntervention. 2009 Dec 15;5 Suppl F:F98-F102. doi: 10.4244/EIJV5IFA17. Review.

ReferenceCitation: Oberhauser JP, Hossainy S, Rapoza RJ. Design principles and performance of bioresorbable polymeric vascular scaffolds. EuroIntervention. 2009 Dec 15;5 Suppl F:F15-22. doi: 10.4244/EIJV5IFA3. Review.

ReferenceCitation: Onuma Y, Serruys PW, Ormiston JA, Regar E, Webster M, Thuesen L, Dudek D, Veldhof S, Rapoza R. Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2010 Sep;6(4):447-53. doi: 10.4244/EIJ30V6I4A76.

ReferenceCitation: Bittl JA. Bioresorbable stents: the next revolution. Circulation. 2010 Nov 30;122(22):2236-8. doi: 10.1161/CIRCULATIONAHA.110.988469. Epub 2010 Nov 15.

ReferenceCitation: Diletti R, Onuma Y, Farooq V, Gomez-Lara J, Brugaletta S, van Geuns RJ, Regar E, de Bruyne B, Dudek D, Thuesen L, Chevalier B, McClean D, Windecker S, Whitbourn R, Smits P, Koolen J, Meredith I, Li D, Veldhof S, Rapoza R, Garcia-Garcia HM, Ormiston JA, Serruys PW. 6-month clinical outcomes following implantation of the bioresorbable everolimus-eluting vascular scaffold in vessels smaller or larger than 2.5 mm. J Am Coll Cardiol. 2011 Jul 12;58(3):258-64. doi: 10.1016/j.jacc.2011.02.052.

ReferenceCitation: Gori T, Schulz E, Hink U, Wenzel P, Post F, Jabs A, Münzel T. Early outcome after implantation of Absorb bioresorbable drug-eluting scaffolds in patients with acute coronary syndromes. EuroIntervention. 2014 Jan 22;9(9):1036-41. doi: 10.4244/EIJV9I9A176.

ReferenceCitation: Simsek C, Magro M, Onuma Y, Boersma E, Smits P, Dorange C, Veldhof S, Regar E, Serruys PW, van Geuns RJ. Procedural and clinical outcomes of the Absorb everolimus-eluting bioresorbable vascular scaffold: one-month results of the Bioresorbable vascular Scaffold Evaluated At Rotterdam Cardiology Hospitals (B-SEARCH). EuroIntervention. 2014 Jun;10(2):236-40. doi: 10.4244/EIJV10I2A38.

ReferenceCitation: Meincke F, Kuck KH, Bergmann MW. Delivery of a bioresorbable vascular scaffold to complex lesions. Catheter Cardiovasc Interv. 2014 Nov 1;84(5):774-8. doi: 10.1002/ccd.25105. Epub 2014 Jul 30.

ReferenceCitation: Kajiya T, Liang M, Sharma RK, Lee CH, Chan MY, Tay E, Chan KH, Tan HC, Low AF. Everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in patients with ST-segment elevation myocardial infarction (STEMI). EuroIntervention. 2013 Aug 22;9(4):501-4. doi: 10.4244/EIJV9I4A80.

ReferenceCitation: Gogas BD, Bourantas CV, Garcia-Garcia HM, Onuma Y, Muramatsu T, Farooq V, Diletti R, van Geuns RJ, De Bruyne B, Chevalier B, Thuesen L, Smits PC, Dudek D, Koolen J, Windecker S, Whitbourn R, McClean D, Dorange C, Miquel-Hebert K, Veldhof S, Rapoza R, Ormiston JA, Serruys PW. The edge vascular response following implantation of the Absorb everolimus-eluting bioresorbable vascular scaffold and the XIENCE V metallic everolimus-eluting stent. First serial follow-up assessment at six months and two years: insights from the first-in-man ABSORB Cohort B and SPIRIT II trials. EuroIntervention. 2013 Oct;9(6):709-20. doi: 10.4244/EIJV9I6A115.

ReferenceCitation: Diletti R, Serruys PW, Farooq V, Sudhir K, Dorange C, Miquel-Hebert K, Veldhof S, Rapoza R, Onuma Y, Garcia-Garcia HM, Chevalier B. ABSORB II randomized controlled trial: a clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: rationale and study design. Am Heart J. 2012 Nov;164(5):654-63. doi: 10.1016/j.ahj.2012.08.010.

ReferenceCitation: Diletti R, Farooq V, Girasis C, Bourantas C, Onuma Y, Heo JH, Gogas BD, van Geuns RJ, Regar E, de Bruyne B, Dudek D, Thuesen L, Chevalier B, McClean D, Windecker S, Whitbourn RJ, Smits P, Koolen J, Meredith I, Li X, Miquel-Hebert K, Veldhof S, Garcia-Garcia HM, Ormiston JA, Serruys PW. Clinical and intravascular imaging outcomes at 1 and 2 years after implantation of absorb everolimus eluting bioresorbable vascular scaffolds in small vessels. Late lumen enlargement: does bioresorption matter with small vessel size? Insight from the ABSORB cohort B trial. Heart. 2013 Jan;99(2):98-105. doi: 10.1136/heartjnl-2012-302598. Epub 2012 Oct 31.

ReferenceCitation: García-García HM, Schultz C, Duckers E, Regar E, Ligthart J, Serruys PW, van Geuns RJ. Five-year follow-up of the ABSORB bioresorbable everolimus-eluting vascular scaffold system: multimodality imaging assessment. EuroIntervention. 2013 Feb 22;8(10):1126-7. doi: 10.4244/EIJV8I10A187.

ReferenceCitation: Gogas BD, Farooq V, Onuma Y, Serruys PW. The ABSORB bioresorbable vascular scaffold: an evolution or revolution in interventional cardiology? Hellenic J Cardiol. 2012 Jul-Aug;53(4):301-9. Review.

ReferenceCitation: Brugaletta S, Garcia-Garcia HM, Onuma Y, Serruys PW. Everolimus-eluting ABSORB bioresorbable vascular scaffold: present and future perspectives. Expert Rev Med Devices. 2012 Jul;9(4):327-38. doi: 10.1586/erd.12.17. Epub 2012 Mar 16. Review.

ReferenceCitation: Gomez-Lara J, Diletti R, Brugaletta S, Onuma Y, Farooq V, Thuesen L, McClean D, Koolen J, Ormiston JA, Windecker S, Whitbourn R, Dudek D, Dorange C, Veldhof S, Rapoza R, Regar E, Garcia-Garcia HM, Serruys PW. Angiographic maximal luminal diameter and appropriate deployment of the everolimus-eluting bioresorbable vascular scaffold as assessed by optical coherence tomography: an ABSORB cohort B trial sub-study. EuroIntervention. 2012 Jun 20;8(2):214-24. doi: 10.4244/EIJV8I2A35.

ReferenceCitation: Sarno G, Bruining N, Onuma Y, Garg S, Brugaletta S, De Winter S, Regar E, Thuesen L, Dudek D, Veldhof S, Dorange C, Garcia-Garcia HM, Ormiston JA, Serruys PW. Morphological and functional evaluation of the bioresorption of the bioresorbable everolimus-eluting vascular scaffold using IVUS, echogenicity and vasomotion testing at two year follow-up: a patient level insight into the ABSORB A clinical trial. Int J Cardiovasc Imaging. 2012 Jan;28(1):51-8. doi: 10.1007/s10554-010-9769-y. Epub 2011 Jan 7.

ReferenceCitation: Cayla G, Koning R, Fajadet J, Sainsous J, Carrié D, Elhadad S, Tarragano F, Lefévre T, Ranc S, Ghostine S, Garot P, Marco F, Maillard L, Motreff P, Le Breton H; FRANCE ABSORB investigators. Percutaneous coronary interventions with the Absorb Bioresorbable vascular scaffold in real life: 1-year results from the FRANCE ABSORB registry. Arch Cardiovasc Dis. 2019 Feb;112(2):113-123. doi: 10.1016/j.acvd.2018.09.007. Epub 2019 Jan 7.

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


title: Incidence of Thromboembolic Events and Prognosis of COVID-19 Patients Hospitalized in Intensive Care Units in France

acronym: COVICLOT

summary: The main objective of this study is to describe the incidence of thromboembolic events in a population of patients hospitalized in intensive care units in France for severe COVID-19. The secondary objective of this study is to describe the evolution of hemostasis parameters during the first two weeks of intensive care hospitalization and to evaluate the influence of different anticoagulation regimens on these parameters and on the incidence of thromboembolic events

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Tacquard C, Mansour A, Godon A, Godet J, Poissy J, Garrigue D, Kipnis E, Rym Hamada S, Mertes PM, Steib A, Ulliel-Roche M, Bouhemad B, Nguyen M, Reizine F, Gouin-Thibault I, Besse MC, Collercandy N, Mankikian S, Levy JH, Gruel Y, Albaladejo P, Susen S, Godier A; French Working Group on Perioperative Hemostasis. Impact of High-Dose Prophylactic Anticoagulation in Critically Ill Patients With COVID-19 Pneumonia. Chest. 2021 Jun;159(6):2417-2427. doi: 10.1016/j.chest.2021.01.017. Epub 2021 Jan 16.

family: Tacquard

full_name: Charles Tacquard

given: Charles

sequence: first

family: Mansour

full_name: Alexandre Mansour

given: Alexandre

sequence: additional

family: Godon

full_name: Alexandre Godon

family: Godet

full_name: Julien Godet

given: Julien

family: Poissy

full_name: Julien Poissy

family: Garrigue

full_name: Delphine Garrigue

given: Delphine

family: Kipnis

full_name: Eric Kipnis

given: Eric

family: Rym Hamada

full_name: Sophie Rym Hamada

given: Sophie

family: Mertes

full_name: Paul Michel Mertes

given: Paul Michel

family: Steib

full_name: Annick Steib

given: Annick

family: Ulliel-Roche

full_name: Mathilde Ulliel-Roche

given: Mathilde

family: Bouhemad

full_name: Bélaïd Bouhemad

given: Bélaïd

family: Nguyen

full_name: Maxime Nguyen

given: Maxime

family: Reizine

full_name: Florian Reizine

given: Florian

family: Gouin-Thibault

full_name: Isabelle Gouin-Thibault

given: Isabelle

family: Besse

full_name: Marie Charlotte Besse

given: Marie Charlotte

family: Collercandy

full_name: Nived Collercandy

given: Nived

family: Mankikian

full_name: Stefan Mankikian

given: Stefan

family: Levy

full_name: Jerrold H. Levy

given: Jerrold H.

family: Gruel

full_name: Yves Gruel

given: Yves

family: Albaladejo

full_name: Pierre Albaladejo

given: Pierre

family: Susen

full_name: Sophie Susen

family: Godier

full_name: Anne Godier

given: Anne

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


title: Validation of "AVICENNE's ELAL": Instrument of Mother Tongue Assessment and Impact of Familial and Transcultural Factors on Early Bilingualism in Migrants' Children Born in France

acronym: BILINGUISME

summary: The primary purpose is the validation of an instrument of the first language assessment. The second purpose is to study the impact of familial and transcultural factors on early bilingualism in migrant children born in France.

status: Completed

study_completion_date_type: Actual

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: The ESPERES Prospective Cohort of Healthcare Workers in France: Study on the Impact of a Chatbot on COVID-19 Vaccine Perceptions and Intentions

summary: Vaccine hesitancy also concerns healthcare workers (HCWs). However, HCWs are at the frontline of the COVID-19 pandemic and identified as a priority target group for COVID-19 vaccines. Thus, the identification of interventions likely to improve COVID-19 vaccine attitudes and intentions among HCWs is of interests to increase the vaccine coverage among HCWs. The study hypothesis is that the use of the same chatbot as the one tested in the general population in France could also improve the COVID-19 vaccine intentions and perceptions in HCWs.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Health Services Research

ipd_sharing: Undecided

status_simplified: Ongoing


acronym: PELVICARE

summary: The incidence of rectal cancers is at 15,000 new cases per year in France of which 10 to 15% are locally advanced (T4bNxM0) at the moment of diagnosis. The rate of invaded resection margins (R1) for these locally advanced and fixed rectal tumours varies from 10 to 20%. The invasion of the resection margins triples the risk of local recurrence. In the absence of surgical treatment, the 5-year survival rate for patients having had pelvic recurrence of rectal cancer is lower than 4% whereas it varies from 35 to 40% in cases of curative resection. The care and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal cancer constitutes, therefore, in the absence of recommendation, a difficult therapeutic problem with great variability in the methods of care and management around the world. These variations in practice can be explained by structural and organizational differences, as well as cultural dissimilarities. With regards to the organization of its healthcare system, Australia is shown to be a leader as regards the care and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal cancer.

ReferenceCitation: Denost Q, Saillour F, Masya L, Martinaud HM, Guillon S, Kret M, Rullier E, Quintard B, Solomon M. Benchmarking trial between France and Australia comparing management of primary rectal cancer beyond TME and locally recurrent rectal cancer (PelviCare Trial): rationale and design. BMC Cancer. 2016 Apr 4;16:262. doi: 10.1186/s12885-016-2286-1.

family: Denost

full_name: Quentin Denost

given: Quentin

family: Saillour

full_name: Florence Saillour

given: Florence

family: Masya

full_name: Lindy Masya

given: Lindy

family: Martinaud

full_name: Helene Maillou Martinaud

given: Helene Maillou

family: Guillon

full_name: Stephanie Guillon

given: Stephanie

family: Kret

full_name: Marion Kret

given: Marion

family: Rullier

full_name: Eric Rullier

family: Quintard

full_name: Bruno Quintard

given: Bruno

family: Solomon

full_name: Michael Solomon

given: Michael

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMC Cancer

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Bordeaux

location_country: Australia France

location_facility:
Hôpital Saint-André
CLCC Val d'Aurelle
Royal Prince Alfred Hospital Sydney
Hopital Lyon Sud
Hôpital Saint-Antoine
Hôpital Purpan
Peter Maccallum Cancer centre
Hopital Beaujon
Hopital Charles Nicolle
Hopital A.Michallon
Institut Paoli Calmette
Centre Oscar Lambret CLCC


title: Prospective Comparative Multicenter Study on the Medico-economical Impact of the Brindley Technique in the Management of Neurogenic Bladder in Patients With Injured Spinal Cord

acronym: BRINDLEY

summary:
Bladder dysfunction is a major problem in patients with complete spinal cord lesions. For patients presenting incontinence or risk for kidney, two major conventional alternatives are possible : conservative therapies (muscarinic receptor antagonists, vanilloids drugs and botulinum toxin in association with catheterization) and surgical techniques intervening in the nervous and urinary system.

Among these last alternatives, the Brindley technique (anterior sacral root stimulation with posterior rhizotomy) is the only technique allowing for the restauration of bladder function, continence, and micturition. The purpose of the study is to compare the Brindley technique with the first conventional approach in France from a medical and economical point of view.

design_allocation: Non-Randomized

primary_purpose: Prevention

location_facility: Neurochirurgie A - Hôpital Pellegrin , Place Amélie Raba-Léon

intervention_type: Device


title: Assessment of Routine Oral Screening Programs for New Prisoners in France

acronym: DepiDent

summary: In 2018, 10 detention centers in France will start organisational programs to improve the quality of screening of oral diseases, relatively to French recommendations, among new prisoners in France. Our study aims 1) to assess the prevalence and nosology of oral diseases ; 2) to describe the care pathway of participants during their stay in the detention center where they were included ; 3) to assess the cost of care per patient, from a societal perspective, using a top-down method.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Post-market Study on Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms

summary: The purpose of this study is to assess the benefits of endovascular repair with Endurant Stent Graft System by documenting overall mortality, complications, the rate of conversion to open surgical repair, and the development and rupture of the aneurysm on a long term, i.e. at 5 years, in a cohort of patients representative of the population treated under real-life conditions of use in France.

lead_sponsor: Medtronic Cardiovascular

location_facility:
Médipôle de Savoie
CHU Limoges
Clinique Claude Bernard
Clinique de la Présentation
CHU Nice, Hôpital Saint-Roch
Hôpital Privé Sainte Marie
Clinique du Millenaire
CHl Toulon - La Seyne sur Mer
Groupe Hospitalier Henri-Mondor
Clinique Sarrus Teinturiers
Clinique Saint Joseph
Hôpital Saint Joseph
Hôpital Paul Desbief
Polyclinique Quimper Sud
Clinique du Mousseau
Hôpital Privé Jean Mermoz
CHU de Besancon, Hôpital Jean Minjoz
Clinique Belledonne
Hôpital Ambroise Paré
Centre Hospitalier d'Avignon

lead_sponsor_type: industriel


title: Post-market Study on Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases

summary: The objective of this study is to assess the benefits of endovascular technique in terms of efficacy and safety of Valiant Thoracic Stent Graft with the Captivia Delivery System in the treatment of thoracic aortic disease, in a cohort of patients representative of the population treated under real-life conditions of use in France for up to 5 years.

status: Active, not recruiting

ipd_sharing: No

ipd_sharing_description: Only multi center data will be available

lead_sponsor: Medtronic Endovascular

location_facility: CHU de Bordeaux, Groupe Hospitalier Pellegrin


type: Other Identifier

title: Does Exercise Consultation Have a Realistic Chance of Increasing the Physical Activity Level of Type 2 Diabetes Patients in Real Life?

acronym: APDT 2

summary:
The prevalence of type 2 diabetes is high and expected to increase dramatically in worldwide, in France and especially in the French West Indies.This chronic disease is associated with premature mortality and various debilitating complications which can be prevented by optimal control of glycaemia, blood pressure and lipids. Diabetes management includes lifestyle modification and medication. Despite numerous studies supporting the benefits of frequent physical activity for people with Type 2 diabetes, an estimated 60±80% of this population remain sedentary. Promotion of physical activity in current diabetes care seems to be inadequate.

The aim of this randomized controlled trial is to evaluate the medium-term effectiveness (after 3 and 6months) of exercise consultation in promoting physical activity in outpatients with Type 2 diabetes.

status: Unknown status

lead_sponsor: University Hospital Center of Martinique

location_facility: CHU de Fort-de-France- Hôpital Pierre Zobda Quitman

intervention_type: Behavioral

status_simplified: Unknown


title: Breast Cancer and Precariousness: Influence of Socio-demographic Inequalities in Cancer Stage at Diagnosis, Treatment Management and Rehabilitation in the Ile de France Area

acronym: DESSEIN

summary:
Precariousness is a multifactorial concept that can be broken down in the form of economic insecurity, and / or social insecurity and / or territorial insecurity. Precariousness has an impact on health that is difficult to assess precisely because it also impacts on other factors that may themselves influence health. Therefore, the understanding of the impact of precariousness on health involves studying individuals in their context.

Our study is designed to assess the impact of precariousness on the history of breast cancer, on care pathways, on treatment and rehabilitation in a multidisciplinary contextual analysis. Indeed, the socio -economic and geographical inequalities affect the history of breast cancer, treatment and its delay and post- treatment rehabilitation.

The main objective of this project is to compare the stage of disease at diagnosis (according to the TNM classification) in deprived and non deprived patients. The secondary objectives are to compare in the two groups - the socio-economic and geographical inequalities - the direct and indirect costs related to the management, the out-of pocket costs and to describe, based on individual inequalities identified, the pathway of care of the patient.

These objectives will be pursued in the framework of an observational cohort study, prospective, multicenter (Ile de France) comparative exposed / unexposed category. Each precarious patient will be matched to a non- precarious patient in the same age group, regardless of the center. The study will include any patient resident in Ile de France seeking treatment for breast cancer, regardless of the stage.

ReferenceCitation: Ngô C, Dinut A, Bochaton A, Charreire H, Desprès C, Baffert S, Lécuru F, Chatellier G. From prospective clinical trial to reducing social inequalities in health: The DESSEIN trial, concept and design of a multidisciplinary study in precarious patients with breast cancer. BMC Public Health. 2019 Nov 4;19(1):1450. doi: 10.1186/s12889-019-7611-6.

family: Ngô

full_name: Charlotte Ngô

given: Charlotte

family: Dinut

full_name: Aurélia Dinut

given: Aurélia

family: Bochaton

full_name: Audrey Bochaton

given: Audrey

family: Charreire

full_name: Hélène Charreire

given: Hélène

family: Desprès

full_name: Caroline Desprès

given: Caroline

family: Baffert

full_name: Sandrine Baffert

given: Sandrine

family: Lécuru

full_name: Fabrice Lécuru

given: Fabrice

family: Chatellier

full_name: Gilles Chatellier

given: Gilles

journal_name: BMC Public Health

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

location_facility: Centre Hopitalier Victor Dupouy Argenteuil

location_facility: Centre Hospitalier Intercommunal Poissy Saint Germain en Laye

location_facility: Centre Hospitalier Intercommunal Créteil

location_facility: Institut Curie Hôpital René-Huguenin site Saint-Cloud


title: Observatory of Pulmonary Arterial Hypertension of Congenital Heart Disease

acronym: ItinerAir

summary:
The complex congenital cardiac malformations are a significant number of different diseases, each having specific natural histories. The interface with pulmonary arterial hypertension (HTAP) is high since the physiology of many of these disorders comprises alterations in pulmonary vasculature.

This observatory is a cohort of 400 patients enrolled in 3 years, older than one month, having been informed and have agreed to participate in the study and with congenital heart disease other than patent foramen ovale as well as a diagnosis of pulmonary hypertension confirmed by cardiac catheterization.

The main objectives of this report are to know

Incidence of congenital heart disease in HTAP France.
Describe the natural history of HTAP in a large population of patients Congenital heart disease in France
The characteristics of HTAP congenital heart disease
Having a cohort study

ReferenceType: background

ReferenceCitation: Berger RM, Beghetti M, Humpl T, Raskob GE, Ivy DD, Jing ZC, Bonnet D, Schulze-Neick I, Barst RJ. Clinical features of paediatric pulmonary hypertension: a registry study. Lancet. 2012 Feb 11;379(9815):537-46. doi: 10.1016/S0140-6736(11)61621-8. Epub 2012 Jan 11.

ReferenceCitation: Barst RJ, McGoon MD, Elliott CG, Foreman AJ, Miller DP, Ivy DD. Survival in childhood pulmonary arterial hypertension: insights from the registry to evaluate early and long-term pulmonary arterial hypertension disease management. Circulation. 2012 Jan 3;125(1):113-22. doi: 10.1161/CIRCULATIONAHA.111.026591. Epub 2011 Nov 15.

ReferenceCitation: Barst RJ, Ivy DD, Foreman AJ, McGoon MD, Rosenzweig EB. Four- and seven-year outcomes of patients with congenital heart disease-associated pulmonary arterial hypertension (from the REVEAL Registry). Am J Cardiol. 2014 Jan 1;113(1):147-55. doi: 10.1016/j.amjcard.2013.09.032. Epub 2013 Oct 4.

ReferenceCitation: Humbert M, Sitbon O, Chaouat A, Bertocchi M, Habib G, Gressin V, Yaici A, Weitzenblum E, Cordier JF, Chabot F, Dromer C, Pison C, Reynaud-Gaubert M, Haloun A, Laurent M, Hachulla E, Simonneau G. Pulmonary arterial hypertension in France: results from a national registry. Am J Respir Crit Care Med. 2006 May 1;173(9):1023-30. Epub 2006 Feb 2.

ReferenceCitation: Fraisse A, Jais X, Schleich JM, di Filippo S, Maragnès P, Beghetti M, Gressin V, Voisin M, Dauphin C, Clerson P, Godart F, Bonnet D. Characteristics and prospective 2-year follow-up of children with pulmonary arterial hypertension in France. Arch Cardiovasc Dis. 2010 Feb;103(2):66-74. doi: 10.1016/j.acvd.2009.12.001. Epub 2010 Feb 11.

ReferenceCitation: van Loon RL, Roofthooft MT, Hillege HL, ten Harkel AD, van Osch-Gevers M, Delhaas T, Kapusta L, Strengers JL, Rammeloo L, Clur SA, Mulder BJ, Berger RM. Pediatric pulmonary hypertension in the Netherlands: epidemiology and characterization during the period 1991 to 2005. Circulation. 2011 Oct 18;124(16):1755-64. doi: 10.1161/CIRCULATIONAHA.110.969584. Epub 2011 Sep 26.

ReferenceCitation: Duffels MG, Engelfriet PM, Berger RM, van Loon RL, Hoendermis E, Vriend JW, van der Velde ET, Bresser P, Mulder BJ. Pulmonary arterial hypertension in congenital heart disease: an epidemiologic perspective from a Dutch registry. Int J Cardiol. 2007 Aug 21;120(2):198-204. Epub 2006 Dec 19.

lead_sponsor: French Cardiology Society


title: Assessment of Practices and of Immunization Programs Against Flu and Pertussis in Maternity Hospitals

acronym: GriCoVax

summary: Implementation of organizational adjustments can enhance involvement of healthcare teams in carrying out flu and pertussis vaccinations, and optimizing access to vaccines for women and their families. Pertussis vaccination of pregnant women is envisaged by the French Health Autority, considering that, given international experiences, vaccination during the second trimester of pregnancy is safe, effective, and would aim to protect babies during the first months of their life. Before considering such a recommendation in France, the acceptability of this strategy by pregnant women and health professionals must be considered.

lead_sponsor: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

location_facility: Maternité Notre Dame de Bon Secours - GH Paris St Joseph


title: Pre-Surgery Assessing HCV, HBV, HIV Status and Revealing During Consultation With Anesthesiologist

acronym: SAHARA

summary: The aim of the study is to assess the feasibility of HCV, HBV, HIV testing (according to the national guidelines) during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France. The feasibility will be the number of tested patients divided by the number of patients who should have been tested according to the national guidelines (for each virus).

status: Terminated

primary_purpose: Diagnostic

intervention_type: Procedure


title: DiabeNord: A 5-year Prospective Follow-up Cohort Study in Pre-diabetic Subjects for the Identification of New Biomarkers

acronym: DiabeNord

summary: The purpose of this study is to identify in prediabetic subjects, physiopathological changes involved in the evolution to type 2 diabetes mellitus and to identify new biomarkers of type 2 diabetes risk in this population.

ReferenceCitation: Wargny M, Smati S, Pichelin M, Bigot-Corbel E, Authier C, Dierry V, Zaïr Y, Jacquin V, Hadjadj S, Boursier J, Cariou B. Fatty liver index is a strong predictor of changes in glycemic status in people with prediabetes: The IT-DIAB study. PLoS One. 2019 Aug 29;14(8):e0221524. doi: 10.1371/journal.pone.0221524. eCollection 2019.

family: Wargny

full_name: Matthieu Wargny

given: Matthieu

family: Smati

full_name: Sarra Smati

given: Sarra

family: Pichelin

full_name: Matthieu Pichelin

family: Bigot-Corbel

full_name: Edith Bigot-Corbel

given: Edith

family: Authier

full_name: Charlotte Authier

family: Dierry

full_name: Violette Dierry

given: Violette

family: Zaïr

full_name: Yassine Zaïr

given: Yassine

family: Jacquin

full_name: Vincent Jacquin

given: Vincent

family: Hadjadj

full_name: Samy Hadjadj

given: Samy

family: Boursier

full_name: Jérôme Boursier

given: Jérôme

family: Cariou

full_name: Bertrand Cariou

given: Bertrand

currency_apc_doaj: USD

journal_name: PLOS ONE

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

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

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

lead_sponsor: Nantes University Hospital

location_facility: Clinical Nutrition Center Naturalpha (CNCN)


title: Iron Deficiency in Infants : Population-wide Study of the Protective Role of Toddler Milk Formula

acronym: CARMA

summary:
ID in children is the most frequent micronutrient deficiency in industrialized countries, including France. ID induces neurological impairment reducing cognitive, motor, and behavioral capacities in children in the short and long term.

The purpose of this study is to evaluate the principal determinants of ID in France in two-year-old children and to improve strategies for prevention and screening.

The main objective is to study the association between iron status in two-year-old infants living in France and the consumption of toddler milk formula after taking non-dairy iron ingestion, parental socioeconomic status and educational level into account.

The secondary objectives are the following :

to estimate the prevalence of ID and ID anemia in 2-year-old children living in France.
to improve clinical tools for ID screening. to improve strategies for laboratory screening.

ReferenceCitation: Baker RD, Greer FR; Committee on Nutrition American Academy of Pediatrics. Diagnosis and prevention of iron deficiency and iron-deficiency anemia in infants and young children (0-3 years of age). Pediatrics. 2010 Nov;126(5):1040-50. doi: 10.1542/peds.2010-2576. Epub 2010 Oct 5.

ReferenceCitation: Domellöf M, Braegger C, Campoy C, Colomb V, Decsi T, Fewtrell M, Hojsak I, Mihatsch W, Molgaard C, Shamir R, Turck D, van Goudoever J; ESPGHAN Committee on Nutrition. Iron requirements of infants and toddlers. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):119-29. doi: 10.1097/MPG.0000000000000206. Review.

ReferenceCitation: Ghisolfi J, Fantino M, Turck D, de Courcy GP, Vidailhet M. Nutrient intakes of children aged 1-2 years as a function of milk consumption, cows' milk or growing-up milk. Public Health Nutr. 2013 Mar;16(3):524-34. doi: 10.1017/S1368980012002893. Epub 2012 Jul 4.

ReferenceCitation: Guivarch C, Sacri AS, Levy C, Bocquet A, Lapidus N, Hercberg S, Hebel P, Chevé A, Copin C, Zouari M, Gouya L, de Montalembert M, Cohen JF, Chalumeau M. Clinical Prediction of Iron Deficiency at Age 2 Years: A National Cross-sectional Study in France. J Pediatr. 2021 Aug;235:212-219. doi: 10.1016/j.jpeds.2021.03.072. Epub 2021 Apr 6.

family: Guivarch

full_name: Claire Guivarch

given: Claire

family: Sacri

full_name: Anne-Sylvia Sacri

given: Anne-Sylvia

family: Levy

full_name: Corinne Levy

given: Corinne

family: Bocquet

full_name: Alain Bocquet

given: Alain

family: Lapidus

full_name: Nathanaël Lapidus

given: Nathanaël

family: Hercberg

full_name: Serge Hercberg

given: Serge

family: Hebel

full_name: Pascale Hebel

given: Pascale

family: Chevé

full_name: Anne Chevé

given: Anne

family: Copin

full_name: Christian Copin

given: Christian

family: Zouari

full_name: Morched Zouari

given: Morched

family: Gouya

full_name: Laurent Gouya

given: Laurent

family: de Montalembert

full_name: Mariane de Montalembert

given: Mariane

family: Cohen

full_name: Jérémie F. Cohen

given: Jérémie F.

family: Chalumeau

full_name: Martin Chalumeau

given: Martin

journal_name: The Journal of Pediatrics

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Sacri AS, Bocquet A, de Montalembert M, Hercberg S, Gouya L, Blondel B, Ganon A, Hebel P, Vincelet C, Thollot F, Rallo M, Gembara P, Levy C, Chalumeau M. Young children formula consumption and iron deficiency at 24 months in the general population: A national-level study. Clin Nutr. 2021 Jan;40(1):166-173. doi: 10.1016/j.clnu.2020.04.041. Epub 2020 May 7.

family: Blondel

full_name: Béatrice Blondel

given: Béatrice


title: Epidemiology and Treatment of Multidrug-resistant (MDR TB) and Extensively Drug- Resistant (XDR TB) Tuberculosis in Strasbourg, France; a 10 Years Retrospective Study

summary: The purpose of this study is to examine the epidemiology of TB MR in Strasbourg and evaluate the second-line anti-tuberculosis treatments effectiveness, and the relevance and adequacy of the treatments with WHO recommendations. During years 2006-2016, all new cases of MDR TB or XDR TB diagnosed Strasbourg University Hospital will be included in the study (22 cases). Data were collected from the Center for Tuberculosis Control (CLAT) records, the patient's medical records.

time_perspective: Retrospective

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service de Maladies Infectieuses et Tropicales


title: Subjective Experience of Adolescents Suffering From Anorexia Nervosa With Antidepressants

summary: The purpose of this study is to explore the experience of adolescents suffering from anorexia nervosa confronted with the prescription of antidepressants

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceCitation: Leblé N, Radon L, Rabot M, Godart N. [Depressive symptoms during anorexia nervosa: State of the art and consequences for an appropriate use of antidepressants]. Encephale. 2017 Feb;43(1):62-68. doi: 10.1016/j.encep.2016.02.017. Epub 2016 Jul 21. Review. French.

ReferenceCitation: Anderson C, Roy T. Patient experiences of taking antidepressants for depression: a secondary qualitative analysis. Res Social Adm Pharm. 2013 Nov-Dec;9(6):884-902. doi: 10.1016/j.sapharm.2012.11.002. Epub 2012 Dec 4.

ipd_sharing: Yes

ipd_sharing_description:
Use of a treatment database, named Actipidos
Interview recording on a Dictaphone [kept all over the study in a locked drawer in a medical office at the Maison de Solenn, and then destroyed].
Verbatim transcription, on a word-formatted file from a computer in a medical office at the Maison de Solenn; computer secured by a password.
Transcripts will be anonymized with an identical number as soon as they are created; no non-anonymized data records will be kept beyond the end of the study.


title: Flows of Emergency Surgery and Delay in Admission to the Operating Room: a Multicenter Prospective Observational Study in France

acronym: ACUTE-FLOW

summary: French hospitals treat non-elective surgery according to three organizational models: in a dedicated multi-specialty emergency operative room (OR), in a dedicated OR within a specialized surgical platform or in any available OR from a list of non-dedicated OR. Some triage algorithms for the classification of non-elective surgery have been described but are not routinely applied. The rate of delay in the management of non-elective surgery in France is not known. Reducing this delay decreased mortality and morbidity in urgent surgery (McIsaac D, et al., CMAJ 2017). Optimizing the flow of non-elective surgery represents a major challenge. The main objective of this study is to determine the rate of delay in admission to the OR in emergency surgery through a multicenter prospective observational study in France. All patients requiring urgent surgical management (<72 hours) will be included. The ideal time for surgery was previously defined by surgeons according to the NEST classification (NEST 1: within minutes; NEST 2: < 1 hour; NEST 3: < 4 hours; NEST 4: < 12 hours; NEST 5: < 48 hours; NEST 6: < 72 hours). For each patient, the ratio between the observed time (actual Time To Surgery [aTTS] ) and the ideal time (ideal Time To Surgery [iTTS]) will be determined. The delay is identified by aTTS/iTTS ratio >1.

lead_sponsor: University Hospital, Lille

location_facility:
Edouard Herriot Hospital
Henri Mondor Hospital
Beaujon Hospital
University Hospital
University hospital
Hôpital sud
Clinique
HEGP


title: EVIDENS: Lung Cancer Patients TrEated With NiVolumab: A LongItuDinal, ProspEctive, ObservatioNal, Multicentric Study

acronym: EVIDENS

summary: This study will describe the characteristics of patients initiating nivolumab treatment for lung cancer and their outcomes over 3 years in France

ReferenceCitation: Barlesi F, Dixmier A, Debieuvre D, Raspaud C, Auliac JB, Benoit N, Bombaron P, Moro-Sibilot D, Audigier-Valette C, Asselain B, Egenod T, Rabeau A, Fayette J, Sanchez ML, Labourey JL, Westeel V, Lamoureux P, Cotte FE, Allan V, Daumont M, Dumanoir J, Reynaud D, Calvet CY, Ozan N, Pérol M. Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study. Oncoimmunology. 2020 Apr 12;9(1):1744898. doi: 10.1080/2162402X.2020.1744898.

name: CNRS, INSERM, CRCM, Assistance Publique Hôpitaux de Marseille, Hopital Nord, Pavillon Mistral, 6ème Étage A, Chemin des Bourrely, Aix Marseille University, Marseille, France

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

name: Department of Pulmonology, Centre Hospitalier Régional d’Orléans, Orléans, France

family: Dixmier

full_name: Adrien Dixmier

given: Adrien

name: Respiratory Medicine Department, Groupe Hospitalier De La Région Mulhouse Sud-Alsace, Hopital Emile Muller, Mulhouse, France

family: Debieuvre

full_name: Didier Debieuvre

given: Didier

name: Department of Pulmonology, Clinique Pasteur, Toulouse, France

family: Raspaud

full_name: Christophe Raspaud

given: Christophe

name: Department of Pulmonology, Centre Hospitalier Intercommunal de Créteil, Créteil, France

family: Auliac

full_name: Jean-Bernard Auliac

given: Jean-Bernard

name: Department of Pulmonology, Clinique de l’Europe, Amiens, France

family: Benoit

full_name: Nicolas Benoit

given: Nicolas

name: Department of Pulmonology, Hôpital Privé Jean Mermoz, Lyon, France

family: Bombaron

full_name: Pierre Bombaron

given: Pierre

name: Thoracic Oncology Unit, SHUPP, Centre Hospitalier Universitaire Grenoble-Alpes, Grenoble Cedex, France

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

name: Department of Pulmonology, Hôpital Sainte-Musse, Toulon, France

family: Audigier-Valette

full_name: Clarisse Audigier-Valette

given: Clarisse

name: Department of Biostatistics, Institut Curie, Paris, France

family: Asselain

full_name: Bernard Asselain

given: Bernard

name: Department of Cutaneous and Thoracic Oncology, Centre Hospitalier Universitaire Dupuytren, Limoges, France

family: Egenod

full_name: Thomas Egenod

given: Thomas

name: Thoracic Oncology Department, Centre Hospitalier Universitaire de Toulouse, Hopital Rangueil, Toulouse, France

family: Rabeau

full_name: Audrey Rabeau

given: Audrey

name: Department of Medicine, Centre Léon Bérard, Lyon, France

family: Fayette

full_name: Jérôme Fayette

given: Jérôme

name: Department of Thoracic Oncology, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Lyon, France

family: Sanchez

full_name: Myriam Locatelli Sanchez

given: Myriam Locatelli

name: Department of Oncology, Hôpital de Carcassonne, Carcasonne, France

family: Labourey

full_name: Jean-Luc Labourey

given: Jean-Luc

name: Chest Disease Department, University Hospital, INSERM UMR 1098, University of Bourgogne Franche-Comté, Besançon, France

family: Westeel

full_name: Virginie Westeel

given: Virginie

name: Bristol-Myers Squibb, Rueil-Malmaison, France

family: Lamoureux

full_name: Pauline Lamoureux

given: Pauline

family: Cotte

full_name: François-Emery Cotte

given: François-Emery

family: Allan

full_name: Victoria Allan

given: Victoria

name: Bristol-Myers Squibb, Braine-l’alleud, Belgium

family: Daumont

full_name: Melinda Daumont

given: Melinda

family: Dumanoir

full_name: Juliette Dumanoir

given: Juliette

family: Reynaud

full_name: Dorothée Reynaud

given: Dorothée

family: Calvet

full_name: Christophe Yannick Calvet

given: Christophe Yannick

name: Department of Medical Oncology, Centre Léon Bérard, Lyon, France


title: Observatoire Des Assistances Monoventriculaires Gauches du Grand Sud

acronym: SOFCAR

summary:
Chronic heart failure is a common disease. It is also a serious disease with a mortality of 50% at 5 years, representing a significant cost in terms of public health expenditure.

Heart transplantation represents the "gold standard" of care for terminal heart failure patients reached the end of the disease despite optimal medical and surgical management of their disease, with a survival rate of transplant patients by 90% at 1 year and 82% at 3 years.

Long term LVAD are an innovative technology available for more than a decade, developed in part because of the shortage of cardiac grafts and high mortality among patients waiting for transplants due to an important pending.

This technique is used substantially only for ten to fifteen years in the world. Survival after implantation of latest devices reaches 80% at 1 year.

In France, this technique is intended for patients with terminal heart failure who ended different pharmacological and invasive therapeutic resources available.

Currently, academic centers that offer the possibility of long-term LVAD support are organized unicentric in order to centralize specialized care for these patients.

Indeed, patients candidates for the establishment of a long-term LVAD are rigorously selected to ensure an acceptable survival.

However, practices vary considerably from one center to another in particular regarding:

Implantation indications,
Pre-implantation patient assessment,
Monitoring,
Implementation of pharmacological treatments, particularly anticoagulants or betablockers.

ipd_sharing_description: ND


acronym: FIBROFRANCE

summary:
"Mortality related to complications of cirrhosis, (hemorrhage, hepatic insufficiency and primary liver cancer) is 15,000 per year in France. These mortality increases, despite that advanced fibrosis can be identified by non-invasive biomarkers and treated, more than 10 years before the onset of complications and cancer. The main goals of the FIBROFRANCE project which started in 1997 (initially called the MULTIVIRC group) were to demonstrate the performance of serum biomarkers in the more frequent chronic liver diseases, to estimate the dynamic of fibrosis progression and finally to demonstrate the feasibility of the fibrosis screening in French people.

The different cohorts of the FIBROFRANCE (HCV, HBV, ALD, NAFLD) permitted many publications among the 186 publications of our group since 1986 in the field of liver fibrosis. These publications included discovery and validation of non-invasive biomarkers (Poynard Gastroenterology 1997, Imbert-Bismut Lancet 2001, Poynard BMC Gastro 2007), modelling fibrosis progression or regression (Poynard Lancet 1997, Poynard Gastroenterology 2002, Poynard J Hepatol 2003) and fibrosis screening (Ratziu APT 2007, Jacqueminet Clin Gastrenterol Hepatol 2008). This research was conducted in Pitié-Salpêtrière hospital for the biochemical and clinical part in connection with national and international networks. Several panels have been identified and the most predictive FibroTest has been patented (US Patent Office 6.631.330) and launched in 2002. This is the first fibrosis biomarker available worldwide (50 countries including USA as FibroSURE) with more than 1 million prescriptions between 2002-2013. FibroTest, has been validated first in hepatitis C and then in hepatitis B alcoholic liver disease and metabolic syndrome. Therefore it is now possible to screen advanced fibrosis in the 4 most frequent liver diseases: alcohol, hepatitis C and B, and metabolic syndrome (diabetes, overweight, and hyperlipemia). For all the patients detected there are therapeutic options to cure the fibrosis or to reduce the progression to cirrhosis and cancer.

FibroTest has been recommended as alternative to biopsy in several guidelines (AFEF, APASL, EASL and CASLD) and more recently in US overview (Chou Annals 2013). It reimbursed in France in chronic hepatitis C. Several factors of fibrosis progression can be present in the same subject, i.e. an overweight and an excessive alcohol consumption. Therefore no realistic screenng strategy can be conducted without taking into account the Interdependence of the different risk factors. Three biomarkers of fibrosis-associated liver injuries have been developed and validated in FIBROFRANCE cohorts: SteatoTest for steatosis (Poynard Comp Hepatol 2005), NashTest for non-alcoholic steatohepatitis (Poynard EASL 2006), and AshTest for alcoholic steatohepatitis (Naveau J Hepatol 2006). For this purpose different cohorts already used for diagnostic validation will be followed at long term for prognostic validations: FIBROFRANCE-ALD (Naveau Hepatology 2010), FIBROFRANCE-NAFLD including dyslipidemia cohort (Ratziu APT 2007) and diabetes cohort (Jacqueminet Clin Gastrenterol Hepatol 2008). These cohorts will allow assessing the prevalence of fibrosis and the specific risks of fibrosis progression imputable to steatosis and steatohepatitis.

ReferenceCitation: Poynard T, Deckmyn O, Rudler M, Peta V, Ngo Y, Vautier M, Akhavan S, Calvez V, Franc C, Castille JM, Drane F, Sakka M, Bonnefont-Rousselot D, Lacorte JM, Saadoun D, Allenbach Y, Benveniste O, Gandjbakhch F, Mayaux J, Lucidarme O, Fautrel B, Ratziu V, Housset C, Thabut D, Cacoub P. Performance of serum apolipoprotein-A1 as a sentinel of Covid-19. PLoS One. 2020 Nov 20;15(11):e0242306. doi: 10.1371/journal.pone.0242306. eCollection 2020.

family: Poynard

full_name: Thierry Poynard

given: Thierry

family: Deckmyn

full_name: Olivier Deckmyn

given: Olivier

family: Rudler

full_name: Marika Rudler

given: Marika

family: Peta

full_name: Valentina Peta

given: Valentina

family: Ngo

full_name: Yen Ngo

given: Yen

family: Vautier

full_name: Mathieu Vautier

given: Mathieu

family: Akhavan

full_name: Sepideh Akhavan

given: Sepideh

family: Calvez

full_name: Vincent Calvez

given: Vincent

family: Franc

full_name: Clemence Franc

given: Clemence

family: Castille

full_name: Jean Marie Castille

given: Jean Marie

family: Drane

full_name: Fabienne Drane

given: Fabienne

family: Sakka

full_name: Mehdi Sakka

given: Mehdi

family: Bonnefont-Rousselot

full_name: Dominique Bonnefont-Rousselot

given: Dominique

family: Lacorte

full_name: Jean Marc Lacorte

given: Jean Marc

family: Saadoun

full_name: David Saadoun

given: David

family: Allenbach

full_name: Yves Allenbach

given: Yves

family: Benveniste

full_name: Olivier Benveniste

family: Gandjbakhch

full_name: Frederique Gandjbakhch

given: Frederique

family: Mayaux

full_name: Julien Mayaux

given: Julien

family: Lucidarme

full_name: Olivier Lucidarme

family: Fautrel

full_name: Bruno Fautrel

given: Bruno

family: Ratziu

full_name: Vlad Ratziu

given: Vlad

family: Housset

full_name: Chantal Housset

given: Chantal

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

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

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

ReferenceCitation: Poynard T, Peta V, Deckmyn O, Pais R, Ngo Y, Charlotte F, Ngo A, Munteanu M, Imbert-Bismut F, Monneret D, Housset C, Thabut D, Valla D, Boitard C, Castera L, Ratziu V; FLIP consortium, the FibroFrance Group, the EPIC-3 program and the QUID-NASH group. Performance of liver biomarkers, in patients at risk of nonalcoholic steato-hepatitis, according to presence of type-2 diabetes. Eur J Gastroenterol Hepatol. 2020 Aug;32(8):998-1007. doi: 10.1097/MEG.0000000000001606.

journal_name: European Journal of Gastroenterology & Hepatology

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Poynard T, Peta V, Deckmyn O, Munteanu M, Moussalli J, Ngo Y, Rudler M, Lebray P, Pais R, Bonyhay L, Charlotte F, Thibault V, Fartoux L, Lucidarme O, Eyraud D, Scatton O, Savier E, Valantin MA, Ngo A, Drane F, Rosmorduc O, Imbert-Bismut F, Housset C, Thabut D, Ratziu V; HECAM-FibroFrance Group. LCR1 and LCR2, two multi-analyte blood tests to assess liver cancer risk in patients without or with cirrhosis. Aliment Pharmacol Ther. 2019 Feb;49(3):308-320. doi: 10.1111/apt.15082. Epub 2018 Dec 19.

name: Hepatology Department; Assistance Publique-Hôpitaux de Paris, Pitié-Salpêtrière Hospital; Paris France

name: Sorbonne Université, INSERM, Saint-Antoine Research Center & Institute of Cardiometabolism and Nutrition (ICAN); Paris France

ReferenceCitation: Munteanu M, Pais R, Peta V, Deckmyn O, Moussalli J, Ngo Y, Rudler M, Lebray P, Charlotte F, Thibault V, Lucidarme O, Ngo A, Imbert-Bismut F, Housset C, Thabut D, Ratziu V, Poynard T; FibroFrance Group. Long-term prognostic value of the FibroTest in patients with non-alcoholic fatty liver disease, compared to chronic hepatitis C, B, and alcoholic liver disease. Aliment Pharmacol Ther. 2018 Nov;48(10):1117-1127. doi: 10.1111/apt.14990. Epub 2018 Oct 17.

name: Hepatology Department; Assistance Publique-Hôpitaux de Paris; Pitié-Salpêtrière Hospital; Paris France

name: Sorbonne Université; INSERM, Saint-Antoine Research Center & Institute of Cardiometabolism and Nutrition (ICAN); Paris France

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

ReferenceCitation: Poynard T, Munteanu M, Charlotte F, Perazzo H, Ngo Y, Deckmyn O, Pais R, Mathurin P, Ratziu V; FLIP consortium, the FibroFrance-CPAM group; FibroFrance-Obese group. Impact of steatosis and inflammation definitions on the performance of NASH tests. Eur J Gastroenterol Hepatol. 2018 Apr;30(4):384-391. doi: 10.1097/MEG.0000000000001033.

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

ReferenceCitation: Poynard T, Pham T, Perazzo H, Munteanu M, Luckina E, Elaribi D, Ngo Y, Bonyhay L, Seurat N, Legroux M, Ngo A, Deckmyn O, Thabut D, Ratziu V, Lucidarme O; FIBROFRANCE-HECAM. Real-Time Shear Wave versus Transient Elastography for Predicting Fibrosis: Applicability, and Impact of Inflammation and Steatosis. A Non-Invasive Comparison. PLoS One. 2016 Oct 5;11(10):e0163276. doi: 10.1371/journal.pone.0163276. eCollection 2016.

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


title: Impact of COVID-19 Infection in Patients With Hepatocellular Carcinoma: An Ambispective Study Nestled in the CHIEF Cohort

summary: Since December 2019, a new disease named COVID-19 linked to a new coronavirus, SARS-CoV2 has emerged in China in the city of Wuhan, Hubei province, spreading very quickly to all 5 continents, and responsible for a pandemic. France is the third most affected country in Europe after Italy and Spain. Groups of patients at a higher risk of developing a severe form of COVID-19 have been defined: this include patients with immunosuppressive disease as cancer or patients with advanced cirrhosis of the liver. Coronavirus liver injury had been described with SARS-CoV 1 and MERS-CoV. There is no data on liver damage associated with COVID-19 infection for compensated or decompensated cirrhotic patients. The objectives of this project are to estimate the incidence of COVID-19 in hepatocellular carcinoma population, both hospital and ambulatory, and to study the impact on the frequency of severe forms, the prognosis, but also liver function, and the management of hepatocellular carcinoma, in this context of pandemic

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Diagnostic Test


title: Observational Study of Bilateral Upper Limb Amputees in France

acronym: ARMOBS

summary:
In France, there is currently no data to directly estimate the number of bilateral upper limb amputations, their characteristics and therapeutic care.

By extrapolation from the Regional Institute of Physical Medicine and Rehabilitation (PMR) Nancy in 2005, the number of new cases of amputated patients with prosthetic fitting of the upper limb was estimated at 355. Epidemiological data from the 2009-2010 Annual Report of the LIMBLESS STATISTICS database (collection of quantitative clinical data and demographic of amputees patients referred by orthopaedic centres in the United Kingdom , whose population's characteristics are similar to France) identified 395 incident cases of upper limb amputation with, 6 bilateral amputations observed. The causes are varied: traumatic, infectious or related to diabetes. The population was relatively young, aged between 15 and 54 year old.

On this basis, the estimated number of new cases of bilateral upper limb amputations throughout France should therefore be about 40 incident cases over a 5-year period.

This observational study is aimed at collecting comprehensive and high quality data to describe the French population of bilateral upper limb amputees.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon, Hôpital Edouard Herriot


type: Other Grant/Funding Number

title: Dysarthria in Parkinson's Disease: Lusophony vs. Francophony Comparison

acronym: FraLusoPark

summary:
Parkinson's disease (PD) affects between 1% and 2% of the world's population aged 60 and older; in Europe the prevalence is around 150 PD patients per 100,000 individuals. PD is classically characterized by a symptomatic triad that includes rest tremor, akinesia and hypertonia and although the motor expression of the symptoms involves mainly the limbs, the muscles implicated in speech production are also subject to specific dysfunctions. Motor speech disorders, so-called dysarthria, can thus be developed by PD patients. The main objective of our project is to evaluate the physiological parameters (acoustics), perceptual markers (intelligibility) and psychosocial impact of dysarthric speech in PD, in the context of language (French vs. Portuguese) modulations. Acoustic parameters are expected to be physiologically-based, linked with the motoric aspects of dysarthric speech. The same degree of impairment of such parameters should be associated with the pathology and be present universally in all patients, even if they speak different languages; that should be also the case of prosodic markers, whereas impairment of speech intelligibility may participate to the psychosocial impact in communication alteration.

PD patients will be enrolled in the study in Aix-en-Provence (N = 60) and Lisbon (N = 60). Their global motor disability will be assessed with dedicated clinical rating scales, without (off) and with (on) pharmacological treatment. Two groups of 60 healthy age-matched volunteers will provide the normal reference for between-group comparisons. Along with the off and on medication clinical examinations, several speech tasks will be recorded. Moreover, speech organ functions will also be assessed during the same examination. The psychosocial impact of dysarthria will be evaluated via self-questionnaires; it will be analysed a posteriori, as well as the speech intelligibility evaluation, and both will strengthen the overall speech assessments. This global investigation will represent a unique opportunity to provide the most precise and reliable description of PD patients' speech and its impacts on intelligibility and quality of life. Challenging and interdisciplinary aspects are combined in our project, which original cross-linguistic approach involves an international collaboration definitely new in the field of motor speech disorders.

ReferenceCitation: Pinto S, Cardoso R, Sadat J, Guimarães I, Mercier C, Santos H, Atkinson-Clement C, Carvalho J, Welby P, Oliveira P, D'Imperio M, Frota S, Letanneux A, Vigario M, Cruz M, Martins IP, Viallet F, Ferreira JJ. Dysarthria in individuals with Parkinson's disease: a protocol for a binational, cross-sectional, case-controlled study in French and European Portuguese (FraLusoPark). BMJ Open. 2016 Nov 17;6(11):e012885. doi: 10.1136/bmjopen-2016-012885.

family: Pinto

full_name: Serge Pinto

given: Serge

family: Cardoso

full_name: Rita Cardoso

given: Rita

family: Sadat

full_name: Jasmin Sadat

given: Jasmin

family: Guimarães

full_name: Isabel Guimarães

given: Isabel

family: Mercier

full_name: Céline Mercier

given: Céline

family: Santos

full_name: Helena Santos

given: Helena

family: Atkinson-Clement

full_name: Cyril Atkinson-Clement

given: Cyril

family: Carvalho

full_name: Joana Carvalho

given: Joana

family: Welby

full_name: Pauline Welby

given: Pauline

family: Oliveira

full_name: Pedro Oliveira

given: Pedro

family: D'Imperio

full_name: Mariapaola D'Imperio

given: Mariapaola

family: Frota

full_name: Sónia Frota

given: Sónia

family: Letanneux

full_name: Alban Letanneux

given: Alban

family: Vigario

full_name: Marina Vigario

given: Marina

family: Cruz

full_name: Marisa Cruz

given: Marisa

family: Martins

full_name: Isabel Pavão Martins

given: Isabel Pavão

family: Viallet

full_name: François Viallet

given: François

family: Ferreira

full_name: Joaquim J Ferreira

given: Joaquim J

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

lead_sponsor: Centre National de la Recherche Scientifique, France

location_facility: Centre Hospitalier du Pays d'Aix - Service de Neurologie


title: Anxiety and Work Resilience Among Tertiary University Hospital Workers During the COVID-19 Outbreak: An Online Survey

summary:
For limiting COVID-19 spreading, the World Health Organisation (WHO) recommended worldwide confinement on 2010. In France, unessential institutions were closed on March 14th and population confinement was decided on March 17th.

Quarantine and/or confinement could lead to psychological effects such as confusion, suicide ideation, post-traumatic stress symptoms or anger COVID-19 outbreak highlighted a considerable proportion of health care workers (HCW) with depression, insomnia, anxiety and distress symptoms. In front line, facing the virus with the fear of contracting it and contaminate their closest. During previous outbreaks (H1N1, SARS), HCWs have been shown to experience such negative psychological effects of confinement as well as work avoidance behaviour and physical interaction reduction with infected patients (4-7).

In France, Covid 19 outbeak led to increase ICU bed capacity with a full reorganization of the human resources. Some caregivers were reassigned to newly setup units admitting or not Covid-19 patients. In the same time, non-caregivers were also encouraged to work at home whenever possible. Thus, every hospital staff member's private and professional life could be altered by the Covid-19 outbreak.

As all these changes in the daily life could induce psychological disturbances, the present study was aimed at assessing the acute anxiety level (main objective) of the staff in our Tertiary University Hospital, (6300 employees). Secondarily, the self-reported insomnia, pain, catastrophism and work avoidance behaviour levels were assessed

ReferenceCitation: Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26. Review.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Phase 3 Study Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty

acronym: Cartipatch

summary: Numerous surgical techniques have been developped for the treatment of chondral and osteochondral defects of the knee. Among those techniques autologous chondrocyte transplantation (ACT) was promising but have potential drawbacks. A novel development by TBF is available. The aim of this randomized trial is to compared this new ACT technique to mosaicoplasty. Final outcomes were measured at 2 years using clinical evaluation scoring system (International Knee Documentation Committee), MRI and arthroscopy with biopsy. 64 patients are needed to detect a mean IKDC difference of at least 15 points with 90% power at a 5% alpha level. Twelve surgical centers in France are involved.

primary_purpose: Treatment

lead_sponsor: University Hospital, Brest

location_facility: Orthopaedic surgery Departement Brest University Hospital

location_facility: Centre médico chirurgical de Dracy-Le-Fort


title: Knowledge and Perception of Resistance to Antimicrobials in French Healthcare Facilities

acronym: PerceptR

summary: The objectives of this survey are to determine the level of antimicrobial resistance knowledge and perception of health care workers (HCW) in France, to measure the impact of health care facilities (HCF) and to identify the drivers and barriers to change. To achieve this goal, a cross-sectional survey on one day with a self-administered questionnaire and semi-structured interviews with HCWs is proposed. This study will be planned in 60 different HCFs randomly selected and expected to include of 2,100 to 10,000 respondents.

time_perspective: Cross-Sectional

ReferenceCitation: Vaillant L, Birgand G, Esposito-Farese M, Astagneau P, Pulcini C, Robert J, Zahar JR, Sales-Wuillemin E, Tubach F, Lucet JC; PerceptR Study group. Awareness among French healthcare workers of the transmission of multidrug resistant organisms: a large cross-sectional survey. Antimicrob Resist Infect Control. 2019 Nov 12;8:173. doi: 10.1186/s13756-019-0625-0. eCollection 2019.

family: Vaillant

full_name: L. Vaillant

given: L.

family: Birgand

full_name: G. Birgand

given: G.

family: Esposito-Farese

full_name: M. Esposito-Farese

given: M.

family: Astagneau

full_name: P. Astagneau

given: P.

family: Pulcini

full_name: C. Pulcini

given: C.

family: Robert

full_name: J. Robert

given: J.

family: Zahar

full_name: J. R. Zahar

given: J. R.

family: Sales-Wuillemin

full_name: E. Sales-Wuillemin

given: E.

family: Tubach

full_name: F. Tubach

given: F.

family: Lucet

full_name: J. C. Lucet

given: J. C.

journal_name: Antimicrobial Resistance & Infection Control

repository_institution: Imperial College London - Spiral

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC


acronym: OFICE

summary:
Brief Summary: The purpose of the OFICE registry is to characterize and describe the CLL patients' population from the Finistere area and evaluates the association between different patient characteristics, prognosis and treatment patterns.

Detailed Description: OFICE is a single center, prospective, observational registry of CLL patients designed to provide a general description of the CLL patients' population from the Finistere area, France. The registry will also provide information on the association of cytogenetic and immunophenotypic characteristics with disease progression, as well as treatment patterns and healthcare resource utilization. These data will be accessible and beneficial for researchers and physicians and will help guide clinical practice and future clinical or fundamental studies.

ReferenceCitation: Debant M, Burgos M, Hemon P, Buscaglia P, Fali T, Melayah S, Le Goux N, Vandier C, Potier-Cartereau M, Pers JO, Tempescul A, Berthou C, Bagacean C, Mignen O, Renaudineau Y. STIM1 at the plasma membrane as a new target in progressive chronic lymphocytic leukemia. J Immunother Cancer. 2019 Apr 23;7(1):111. doi: 10.1186/s40425-019-0591-3.

family: Debant

full_name: Marjolaine Debant

given: Marjolaine

family: Burgos

full_name: Miguel Burgos

given: Miguel

family: Hemon

full_name: Patrice Hemon

given: Patrice

family: Buscaglia

full_name: Paul Buscaglia

given: Paul

family: Fali

full_name: Tinhinane Fali

given: Tinhinane

family: Melayah

full_name: Sarra Melayah

given: Sarra

family: Le Goux

full_name: Nelig Le Goux

given: Nelig

family: Vandier

full_name: Christophe Vandier

given: Christophe

family: Potier-Cartereau

full_name: Marie Potier-Cartereau

given: Marie

family: Pers

full_name: Jacques-Olivier Pers

given: Jacques-Olivier

family: Tempescul

full_name: Adrian Tempescul

given: Adrian

family: Berthou

full_name: Christian Berthou

given: Christian

family: Bagacean

full_name: Cristina Bagacean

given: Cristina

family: Mignen

full_name: Olivier Mignen

given: Olivier

family: Renaudineau

full_name: Yves Renaudineau

given: Yves

journal_name: Journal for ImmunoTherapy of Cancer

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Bagacean C, Tempescul A, Ternant D, Banet A, Douet-Guilbert N, Bordron A, Bendaoud B, Saad H, Zdrenghea M, Berthou C, Paintaud G, Renaudineau Y. 17p deletion strongly influences rituximab elimination in chronic lymphocytic leukemia. J Immunother Cancer. 2019 Jan 29;7(1):22. doi: 10.1186/s40425-019-0509-0.


title: Screening for Cancers in the Oral CAvity Targeting Tobacco Users in Somme, France

acronym: IDECAB

summary:
In the Somme region of France, cancer registry data showed an increasing incidence of oral cancer. The Incidence Rates in Somme as compared to the national rates for Lip, Oral Cavity and Pharynx Cancer were in 2010: 31,4/100 000 Standard population versus 18,2 /100 000 for male and 8,2/100 000 versus 5,5/100 000 for female, disaster area where action to improve early detection for smokers will be assessed. This target population consults late (as 70% of oral cavity cancers are diagnosed at a late stage (T3 or T4). This project is an innovative incentive strategy for screening among general practitioners based on unusual information vectors (tobacconist, local media).

The main objective of this study is a screening of oral cavity cancers in tobacco users aged 30-75 years in the Somme region of France.

ReferenceCitation: Bailey EE, Marghoob AA, Orengo IF, Testa MA, White VR, Geller AC. Skin cancer knowledge, attitudes, and behaviors in the salon: a survey of working hair professionals in Houston, Texas. Arch Dermatol. 2011 Oct;147(10):1159-65. doi: 10.1001/archdermatol.2011.184.

ReferenceCitation: Subramanian S, Sankaranarayanan R, Bapat B, Somanathan T, Thomas G, Mathew B, Vinoda J, Ramadas K. Cost-effectiveness of oral cancer screening: results from a cluster randomized controlled trial in India. Bull World Health Organ. 2009 Mar;87(3):200-6.

ReferenceCitation: Epstein JB, Silverman S Jr, Epstein JD, Lonky SA, Bride MA. Analysis of oral lesion biopsies identified and evaluated by visual examination, chemiluminescence and toluidine blue. Oral Oncol. 2008 Jun;44(6):538-44. Epub 2007 Nov 8. Erratum in: Oral Oncol. 2008 Jun;44(6):615.

ReferenceCitation: Hubert A, Lapôtre B, Raverdy N, Ganry O. Incidence et mortalité 2002-2004 Evolution de 1982 à 2004. Registre du Cancer de la Somme. Juin 2009. 138 p.

ReferenceCitation: Réseau Francim, service de biostatistique des hospices civils de Lyon. Survie des patients atteints de Cancer en France : étude des registres du réseau Francim, Paris 2007, springer, 406

ReferenceCitation: Reyt E, Righini C. Les cancers du plancher buccal. La chirurgie mini-invasive. Société française de carcinologie cervico-faciale.EDK


title: Epidémiologie Des Gestes Douloureux ou Stressants Chez Les Nouveau-nés Pris en Charge Dans Les unités de réanimation néonatale et pédiatrique et Par Les équipes de SMUR de la région d'Ile de France

acronym: EPIPPAIN

summary:
Sick or premature neonates are exposed to frequent painful and stressful procedures during their stay in neonatal intensive care units. Although neonates do feel pain and may have long term effects induced by painful experiences, prevention and treatment of neonatal pain is far from optimal in many units. An epidemiological study (EPIPPAIN) conducted in neonatal and pediatric intensive care units in France in 2005 showed that painful procedures were extremely frequent and that analgesics treatments varied a lot among units. Since many guidelines have been issued by international scientific societies to manage neonatal pain, one may expect that the prevention and treatment of neonatal pain has improved over the last 6 years.

Although awake endotracheal intubations are extremely difficult or impossible in older children or adults, such intubations are still frequently performed without sedation/analgesia in neonates. Recent studies have shown that premedications facilitate intubation conditions and greatly improve neonates tolerance of the procedure. Studies aimed at assessing the risks and benefits of different sedations/analgesia strategies are urgently needed in neonates. We also need a tool to assess at the same time the technical conditions of intubations and the tolerance of the neonate to the procedure so that data from different studies can be compared.

The objectives of the present study are:

To describe the incidence of painful and stressful procedures performed in the neonate in intensive care units as well as in neonates transported by the medical emergency system (SMUR) of the Ile-de-France region 6 years after the first EPPIPAIN study conducted in the same region and same type of population in order to assess the evolution of practices. The description of painful and stressful procedures will be completed with a real-time around-the-clock assessment of the pain induced by procedures using a validated behavioral pain scale.
To link this study with The Epipage study 2 in order to look for associations between the number of painful and stressful procedures and/or analgesic treatments of the neonatal period and the neurological outcome of children that will be followed in the Epipage cohort. The Epipage study is a separate study that will follow for 13 years a cohort of premature neonates recruited in 2011.
To describe the incidence of painful or stressful procedures and analgesic treatments in neonates transported by the pediatric emergency system (SMUR) of the Ile-de-France region in France.
To obtain initial validity of a tool permitting to assess intubations in neonates. An observational detailed description of endotracheal intubations conditions will be conducted in neonates transported and intubated by SMUR and in neonates intubated in intensive care units
To describe continuous sedation and analgesia practices in ventilated neonates in intensive care units. For these neonates, data from medical records will be recovered up to 2 months of admission in intensive care units
To describe the frequency of heel sticks for glycemia measurement and blood gazes practices among centers. Relate heel stick practices to the normality or abnormality of glycemia results

ReferenceCitation: Carbajal R, Lode N, Ayachi A, Chouakri O, Henry-Larzul V, Kessous K, Normand A, Courtois E, Rousseau J, Cimerman P, Chabernaud JL. Premedication practices for tracheal intubation in neonates transported by French medical transport teams: a prospective observational study. BMJ Open. 2019 Nov 14;9(11):e034052. doi: 10.1136/bmjopen-2019-034052.

family: Carbajal

full_name: Ricardo Carbajal

given: Ricardo

family: Lode

full_name: Noella Lode

given: Noella

family: Ayachi

full_name: Azzedine Ayachi

given: Azzedine

family: Chouakri

full_name: Ourida Chouakri

given: Ourida

family: Henry-Larzul

full_name: Véronique Henry-Larzul

given: Véronique

family: Kessous

full_name: Katia Kessous

given: Katia

family: Normand

full_name: Audrey Normand

given: Audrey

family: Courtois

full_name: Emilie Courtois

given: Emilie

family: Rousseau

full_name: Jessica Rousseau

given: Jessica

family: Cimerman

full_name: Patricia Cimerman

given: Patricia

family: Chabernaud

full_name: Jean-Louis Chabernaud

given: Jean-Louis

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

ReferenceCitation: Courtois E, Cimerman P, Dubuche V, Goiset MF, Orfèvre C, Lagarde A, Sgaggero B, Guiot C, Goussot M, Huraux E, Nanquette MC, Butel C, Ferreira AM, Lacoste S, Séjourné S, Jolly V, Lajoie G, Maillard V, Guedj R, Chappuy H, Carbajal R. The burden of venipuncture pain in neonatal intensive care units: EPIPPAIN 2, a prospective observational study. Int J Nurs Stud. 2016 May;57:48-59. doi: 10.1016/j.ijnurstu.2016.01.014. Epub 2016 Feb 8.

journal_name: International Journal of Nursing Studies

location_facility: Hôpital Louis Mourier. Service de réanimation néonatale

location_facility: Centre Hospitalier René Dubos. Service de réanimation néonatale

location_facility: Hôpital de Bicêtre. Service de réanimation pédiatrique et néonatale

location_facility: Hôpital Necker Enfants Malades. Service de réanimation pédiatrique et néonatale

location_facility: Hôpital Victor Dupouy. Service de réanimation néonatale

location_facility: Hôpital Armand Trousseau. Service de Réanimation Pédiatrique

location_facility: Hôpital du Sud Francilien. Service de réanimation néonatale

location_facility: Institut de Puériculture et de Périnatalogie. Service de réanimation néonatale

location_facility: CHI Créteil. Service de réanimation néonatale

location_facility: Hôpital Delafontaine. Service de réanimation néonatale

location_facility: Hôpital Robert Debré. Service de réanimation néonatale

location_facility: Centre Hospitalier Intercommunal de Poissy Saint Germain en Laye Service de réanimation néonatale

location_facility: Hôpital Cochin-Port Royal. Service de médecine néonatale

location_facility: Hôpital de Meaux. Service de réanimation néonatale

location_facility: CHI André Grégoire. Service de réanimation néonatale

location_facility: Hôpital Antoine Béclère. Service de réanimation néonatale


title: A National, Prospective, Non- Interventional Study (NIS) in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma and Subsequent Treatments in Case of Relapse

acronym: AdjuMel

summary: This is an observational prospective study to estimate in real world conditions the effectiveness, the safety profile and the pattern of use of adjuvant nivolumab in adults participants with stage III/IV resected melanoma, and subsequent treatments administered in case of relapse.

lead_sponsor: Bristol-Myers Squibb


title: Morbidity and Mortality Associated With the Care Journey in Children and Adolescents With Hyperthyroidism

acronym: MOTHYRE

summary:
"Early paediatric Basedow disease is one of the rare endocrine diseases for which the Reference Centre for Rare Endocrine Growth Diseases, was approved by the Ministry of Health in 2005. In addition, the study will benefit from the expertise of public Health France (SFP). This study is therefore part of the missions of these partners (reference centre for endocrine growth diseases and Public Health France).

For several years, our group has been interested in defining the evolutionary profile of these patients. A national study on short- and long-term patient follow-up has already been conducted, which has been the subject of two international publications29,30, as well as a study on a specific clinical form of the disease 24. This work was made possible thanks to the collaboration of paediatric clinical centres within the Reference Centre and Competence Centre for Rare Endocrine Diseases Network. The present study planned in France will make it possible to accurately characterize the care pathway and the frequency of complications associated with it at the national level.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: The Use of Complementary Medicine in Palliative/Supportive Care Centres in Lyon, France

summary:
Palliative care centres in Lyon, France as well as the disclosure of Complementary and Alternative Medicine and conventional healthcare use to conventional and Complementary and Alternative Medicine practitioners respectively.

These aims will be achieved through the following objectives:

Describe the prevalence of Complementary and Alternative Medicine practitioner and product use in the outpatient population of palliative care centres in Lyon, France
Describe the characteristics of Complementary and Alternative Medicine users the outpatient population of palliative care centres in Lyon, France
Estimate the Complementary and Alternative Medicine expenditure of the outpatient population of palliative care centres in Lyon, France
Describe the rates of disclosure of both Complementary and Alternative Medicine and conventional health care to health professionals by the outpatient population of palliative care centres in Lyon, France
Describe the reasons for disclosure or non-disclosure of both Complementary and Alternative Medicine and conventional health care to health professionals by the outpatient population of palliative care centres in Lyon, France

location_facility: USP de Charmettes - Croix rouge française

location_facility: Centre de Soins Palliatifs Lyon-Sud Pavillon 1K - Centre Hospitalier Lyon-Sud

location_facility: Service E.M.S.P. Groupement Hospitalier Nord - Hôpital de la Croix-Rousse


title: National SFCE Cohort of SARS-CoV-2 Infections (COVID-19) in Pediatric Oncology and Hematology

acronym: PEDONCOVID

summary: Since the description of the first cases of infection in December 2019 in the Hubei province in China, a new coronavirus, called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), emerged and caused a pandemic. This new virus is responsible for an infectious disease with respiratory and potent severe symptoms, called COVID-19 (coronavirus disease 2019). The first data concerned essentially the adult population and gave a clinical description of the disease. However, data is missing in the pediatric population. The first published studies indicate that children seem to have a lower risk to get a severe form of COVID-19. Except the case of a child with leukemia recently described with the diagnosis of COVID-19, there is currently no data about pediatric patients with an oncology history or under chemotherapeutic drugs. Cancers are rare among children and is estimated to concern about 1700 new cases in a year in France. Malignant tumor or its treatment can affect self-immunity, which could favor SARS-CoV-2 infection or its aggravation. Thus, the investigators propose in this study to collect data about French children with a cancer and diagnosed with COVID-19.The analysis of the collected data will refine clinical characteristics of SARS-CoV-2 infection in this population. It will be critical for elaborating recommendations for the management of COVID-19 in children with cancer.

lead_sponsor: University Hospital, Caen


title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in France.

summary: The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccines in France.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

intervention_type: Drug


title: Automatic Remifentanil Administration Guided by the Analgesia Nociception Index During Propofol Anesthesia

acronym: ANI-LOOP

summary: Prospective Randomized Monocentric Clinical Trial during propofol anesthesia. The aim of the study is to test whether the use of a medical device designed to automatically administer remifentanil during surgery based on expert rules and continuous reading of heart rate, blood pressure and the Analgesia Nociception Index results in lower overall remifentanil administration versus standard practice.


title: Comparison of Patient Care Management Strategies of Heart Failure in the Rhône-Alpes Region. A Clinical and Economic Study.

acronym: EFFICARD

summary:
The heart failure is a chronic pathology with prevalence from 2 to 3% of general population, a death rate of 50% at 6 months for patients with stage IV, and a probability of death or hospitalization or emergency consultation of 40% at 3 years. The care of patients is heterogeneous, especially in light of the organization of therapeutic education offered to patients and patient monitoring modalities.

The aim of this study is to investigate the management strategies for patients with chronic heart failure stage III or IV NYHA, and heart failure patients with stage II NYHA with previous hospitalization for heart failure.

This is a longitudinal observational multicenter study comparing a management strategy including patient education and monitoring as part of a hospital dedicated organization and an organization of care as usually done in France.

The primary endpoint was a composite endpoint of morbidity and mortality involving deaths, unplanned readmissions and emergency visits for heart failure.

The expected number of patients is 720 patients (360 per strategy). The follow-up duration of 24 months.


ReferenceCitation: Shimono K, Tung WE, Macolino C, Chi AH, Didizian JH, Mundy C, Chandraratna RA, Mishina Y, Enomoto-Iwamoto M, Pacifici M, Iwamoto M. Potent inhibition of heterotopic ossification by nuclear retinoic acid receptor-γ agonists. Nat Med. 2011 Apr;17(4):454-60. doi: 10.1038/nm.2334. Epub 2011 Apr 3. Erratum in: Nat Med. 2012 Oct;18(10):1592.

lead_sponsor: Clementia Pharmaceuticals Inc.

location_facility: Hôpital Necker-Enfants Malades, Department of Genetics

type: EudraCT Number

source: euctr

title: A Phase 2, Open-Label Extension, Efficacy and Safety Study of a Retinoic Acid Receptor Gamma (RARγ)-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects With Fibrodysplasia Ossificans Progressiva (FOP)

summary:
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO), i.e., abnormal bone formation, often associated with painful, recurrent episodes of soft tissue swelling (flare-ups). Lesions begin in early childhood and lead to progressive ankyloses of major joints with resultant loss of movement.

In this study, the ability of different palovarotene dosing regimens to prevent the formation of new HO will be evaluated in adult and pediatric participants with FOP in France.


type: Registry Identifier

title: RApid Fluid Volume EXpansion (RVE) in Critically Ill Patients With Acute Circulatory Failure After the Initial Phase of Resuscitation. A Single-center, Open-label, Randomized Study Comparing 3 Strategies of RVE in Orléans, France.

acronym: RAVEXO

summary: Rapid volume expansion using repeated intravenous fluid boluses is a very common intervention performed in the intensive care unit (ICU) in the early days of resuscitation of patients with shock. Once passed the initial phase of resuscitation, the fluid boluses administered fail to effectively increase the patients' cardiac output in about 50% of cases. Pulse pressure changes or stroke volume changes induced by a Passive Leg Raising (PLR) test have acceptable/good ability to predict fluid responsiveness (in terms of cardiac output change) and may be systematically used in patients with persistent shock with the aim of limiting the total amount of fluid administered to patients by avoiding undue fluid boluses. One may suppose that such a volume expansion management policy could impact morbidity and mortality of shocked patients. Among the predictive indices available in clinical practice, the PLR test has the advantages of being usable regardless of the patients' respiratory status and cardiac rhythm. Changes in left ventricular stroke volume during the PLR test perform better that changes in pulse pressure to predict fluid responsiveness. However, in counterpart, pulse pressure changes during PLR can be assessed without the need of other hemodynamic exploration such central venous pressure measurement or cardiac output monitoring. The investigators hypothesized that strategies using either stroke volume changes or pulse pressure changes induced by the PLR test to decide wether a fluid bolus clinically deemed indicated should or should not be administered, may limit the amount of fluid received by the patients during the first 5 days of shock, improve their oxygenation index, and shorten the time passed under mechanical ventilation, as compared to a "liberal" strategy (usual care) that does not use predictive indices of fluid responsiveness.

ReferenceCitation: Annane D, Sébille V, Charpentier C, Bollaert PE, François B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troché G, Chaumet-Riffaud P, Bellissant E. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002 Aug 21;288(7):862-71. Erratum in: JAMA. 2008 Oct 8;300(14):1652. Chaumet-Riffaut, Philippe [corrected to Chaumet-Riffaud, Philippe].

ReferenceCitation: Annane D, Sébille V, Duboc D, Le Heuzey JY, Sadoul N, Bouvier E, Bellissant E. Incidence and prognosis of sustained arrhythmias in critically ill patients. Am J Respir Crit Care Med. 2008 Jul 1;178(1):20-5. doi: 10.1164/rccm.200701-031OC. Epub 2008 Apr 3.

ReferenceCitation: Antonelli M, Levy M, Andrews PJ, Chastre J, Hudson LD, Manthous C, Meduri GU, Moreno RP, Putensen C, Stewart T, Torres A. Hemodynamic monitoring in shock and implications for management. International Consensus Conference, Paris, France, 27-28 April 2006. Intensive Care Med. 2007 Apr;33(4):575-90.

ReferenceCitation: Benes J, Chytra I, Altmann P, Hluchy M, Kasal E, Svitak R, Pradl R, Stepan M. Intraoperative fluid optimization using stroke volume variation in high risk surgical patients: results of prospective randomized study. Crit Care. 2010;14(3):R118. doi: 10.1186/cc9070. Epub 2010 Jun 16.

ReferenceCitation: Boulain T, Achard JM, Teboul JL, Richard C, Perrotin D, Ginies G. Changes in BP induced by passive leg raising predict response to fluid loading in critically ill patients. Chest. 2002 Apr;121(4):1245-52.

ReferenceCitation: Boulain T, Garot D, Vignon P, Lascarrou JB, Desachy A, Botoc V, Follin A, Frat JP, Bellec F, Quenot JP, Mathonnet A, Dequin PF; Clinical Research in Intensive Care and Sepsis Group. Prevalence of low central venous oxygen saturation in the first hours of intensive care unit admission and associated mortality in septic shock patients: a prospective multicentre study. Crit Care. 2014 Nov 6;18(6):609. doi: 10.1186/s13054-014-0609-7.

ReferenceCitation: Boulain T, Boisrame-Helms J, Ehrmann S, Lascarrou JB, Bouglé A, Chiche A, Lakhal K, Gaudry S, Perbet S, Desachy A, Cabasson S, Geneau I, Courouble P, Clavieras N, Massanet PL, Bellec F, Falquet Y, Réminiac F, Vignon P, Dequin PF, Meziani F. Volume expansion in the first 4 days of shock: a prospective multicentre study in 19 French intensive care units. Intensive Care Med. 2015 Feb;41(2):248-56. doi: 10.1007/s00134-014-3576-1. Epub 2014 Dec 2.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility: Centre Hospitalier Régional d'Orléans, France


title: Epidemiological, Prospective, Multicentric, Open Study To Assess The Characteristics And Frequency Of Adenoviral Conjunctivitis As Diagnosed With The Point Of Care AdenoPlus® Test In Patients Suffering From Acute Conjunctivitis

summary: The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.

lead_sponsor: NicOx

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

location_facility: Groupe Hospitalier La Pitié Salpêtrière-Charles Foix


title: Prevalence Study Evaluating the Acquisition of Carriage of Resistant Bacteria in the Gut Flora in Volunteers From French Armed Forces Coming Back From External Operations

acronym: MARC

summary: Prevalence Study evaluating the acquisition of carriage of multidrug-resistant Gram-negative bacteria (MDRGNB) in the gut flora in volunteers of French Armed Forces staying from 4 to 6 months outside France.

lead_sponsor: Da Volterra

location_facility: Centre d'épidémiologie et de santé publique des armées


title: Antitetanus Vaccination for People Older Than 65 Years in the Auvergne-Rhône-Alpes (France) Region Depending on the Demographic and Medical Practice of Their Medical Practitioner.

summary:
In the last ten years, more than one hundred generalized tetanus cases were declared in France. Most of them were affecting people older than 70 years with an important mortality (around 28%). It is know that the only way to protect ourselves from this disease is the vaccination. In France tetanus vaccination is mandatory since 1940.

Nowaday none study looked specifically for the vaccination of people older than 65 years. The hypothesis is: there is a difference in the tetanus vaccination coverage for people older than 65 years depending on the demographic and medical practice of their general practitioner.

location_facility: Service Urgence et Réanimation Pédiatrique Hôpital Femme Mère Enfant Groupement Hospitalier Est