title: Ependymomics: Multiomic Approach to Radioresistance of Ependymomas in Children and Adolescents

acronym: EPENDYMOMICS

summary:
Treatment of childhood ependymoma, the second most frequent pediatric brain tumor, is based on surgery and radiation therapy. However, 50% relapse, mainly locally. Progress in imaging, molecular biology and radiotherapy ballistics has led us to propose the EPENDYMOMICS project, a multi-omics approach using artificial intelligence to detect the predictive characteristics of relapse, and to define innovative radiotherapy targets using multimodal imaging. We previously reported that the relapse sites are mainly located in the high-dose radiotherapy zone and that there appear to be prognostic factors for relapse based on anatomical and functional MRI abnormalities by diffusion and perfusion. In addition, recent studies in molecular biology have identified significant prognostic factors. The challenge now is to use and correlate all these findings in larger cohorts to tackle the radio-resistance of this disease.

Our objective is to collate in a single database called NETSPARE (Network to Structure and Share Pediatric data to Accelerate Research on Ependymoma) the clinical, histological, biological, imaging and radiotherapy data from two consecutive studies that included 370 children and adolescents with ependymoma since 2000 in France. The EPENDYMOMICS project will comprise a clinical research team, three imaging research teams, two histopathology teams, and a biostatistics team working on NETSPARE. Our goal is to obtain a radiogenomic signature of our data, which will be validated with the English external cohort of 200 patients that is currently being analyzed. The perspective is to optimize the indications and volumes of irradiation that could in the future be used in a European translational research trial to tackle radioresistance.

ReferenceCitation: Tensaouti F, Ducassou A, Chaltiel L, Bolle S, Muracciole X, Coche-Dequeant B, Alapetite C, Bernier V, Claude L, Supiot S, Huchet A, Kerr C, le Prise E, Laprie A; radiotherapy committee of the French Society for Childhood Cancer (SFCE). Patterns of failure after radiotherapy for pediatric patients with intracranial ependymoma. Radiother Oncol. 2017 Mar;122(3):362-367. doi: 10.1016/j.radonc.2016.12.025. Epub 2017 Jan 12.

ReferenceCitation: Ducassou A, Padovani L, Chaltiel L, Bolle S, Habrand JL, Claude L, Carrie C, Muracciole X, Coche-Dequeant B, Alapetite C, Supiot S, Demoor-Goldschmidt C, Bernier-Chastagner V, Huchet A, Leseur J, Le Prise E, Kerr C, Truc G, Nguyen TD, Bertozzi AI, Frappaz D, Boetto S, Sevely A, Tensaouti F, Laprie A; Pediatric French Radiation Oncologist Group (GFRP) and the French Society of Children With Cancer (SFCE). Pediatric Localized Intracranial Ependymomas: A Multicenter Analysis of the Societe Francaise de lutte contre les Cancers de l'Enfant (SFCE) from 2000 to 2013. Int J Radiat Oncol Biol Phys. 2018 Sep 1;102(1):166-173. doi: 10.1016/j.ijrobp.2018.05.036. Epub 2018 May 24.

ReferenceCitation: Tensaouti F, Ducassou A, Chaltiel L, Sevely A, Bolle S, Muracciole X, Coche-Dequant B, Alapetite C, Supiot S, Huchet A, Bernier V, Claude L, Bertozzi-Salamon AI, Liceaga S, Lotterie JA, Peran P, Payoux P, Laprie A; radiotherapy committee of the French Society for Childhood Cancer (SFCE). Prognostic and predictive values of diffusion and perfusion MRI in paediatric intracranial ependymomas in a large national study. Br J Radiol. 2016 Oct;89(1066):20160537. doi: 10.1259/bjr.20160537. Epub 2016 Aug 23.

ReferenceCitation: Tensaouti F, Ducassou A, Chaltiel L, Sevely A, Bolle S, Padovani L, Jouin A, Alapetite C, Supiot S, Huchet A, Bernier V, Claude L, Kerr C, Le Prise E, Bertozzi-Salamon AI, Liceaga S, Lotterie JA, Peran P, Laprie A; French Society for Childhood Cancer (SFCE). Imaging biomarkers of outcome after radiotherapy for pediatric ependymoma. Radiother Oncol. 2018 Apr;127(1):103-107. doi: 10.1016/j.radonc.2018.02.008. Epub 2018 Mar 2.

ReferenceCitation: Tensaouti F, Ducassou A, Chaltiel L, Bolle S, Habrand JL, Alapetite C, Coche-Dequeant B, Bernier V, Claude L, Carrie C, Padovani L, Muracciole X, Supiot S, Huchet A, Leseur J, Kerr C, Hangard G, Lisbona A, Goudjil F, Ferrand R, Laprie A. Feasibility of Dose Escalation in Patients With Intracranial Pediatric Ependymoma. Front Oncol. 2019 Jun 21;9:531. doi: 10.3389/fonc.2019.00531. eCollection 2019.

ReferenceCitation: Pajtler KW, Mack SC, Ramaswamy V, Smith CA, Witt H, Smith A, Hansford JR, von Hoff K, Wright KD, Hwang E, Frappaz D, Kanemura Y, Massimino M, Faure-Conter C, Modena P, Tabori U, Warren KE, Holland EC, Ichimura K, Giangaspero F, Castel D, von Deimling A, Kool M, Dirks PB, Grundy RG, Foreman NK, Gajjar A, Korshunov A, Finlay J, Gilbertson RJ, Ellison DW, Aldape KD, Merchant TE, Bouffet E, Pfister SM, Taylor MD. The current consensus on the clinical management of intracranial ependymoma and its distinct molecular variants. Acta Neuropathol. 2017 Jan;133(1):5-12. doi: 10.1007/s00401-016-1643-0. Epub 2016 Nov 17.

ReferenceCitation: Da-Ano R, Visvikis D, Hatt M. Harmonization strategies for multicenter radiomics investigations. Phys Med Biol. 2020 Dec 17;65(24):24TR02. doi: 10.1088/1361-6560/aba798.

ReferenceCitation: Johnson WE, Li C, Rabinovic A. Adjusting batch effects in microarray expression data using empirical Bayes methods. Biostatistics. 2007 Jan;8(1):118-27. doi: 10.1093/biostatistics/kxj037. Epub 2006 Apr 21.

ReferenceCitation: Chen C, Grennan K, Badner J, Zhang D, Gershon E, Jin L, Liu C. Removing batch effects in analysis of expression microarray data: an evaluation of six batch adjustment methods. PLoS One. 2011 Feb 28;6(2):e17238. doi: 10.1371/journal.pone.0017238.

ReferenceCitation: Da-Ano R, Masson I, Lucia F, Dore M, Robin P, Alfieri J, Rousseau C, Mervoyer A, Reinhold C, Castelli J, De Crevoisier R, Ramee JF, Pradier O, Schick U, Visvikis D, Hatt M. Performance comparison of modified ComBat for harmonization of radiomic features for multicenter studies. Sci Rep. 2020 Jun 24;10(1):10248. doi: 10.1038/s41598-020-66110-w.

ReferenceCitation: Louis DN, Wesseling P, Aldape K, Brat DJ, Capper D, Cree IA, Eberhart C, Figarella-Branger D, Fouladi M, Fuller GN, Giannini C, Haberler C, Hawkins C, Komori T, Kros JM, Ng HK, Orr BA, Park SH, Paulus W, Perry A, Pietsch T, Reifenberger G, Rosenblum M, Rous B, Sahm F, Sarkar C, Solomon DA, Tabori U, van den Bent MJ, von Deimling A, Weller M, White VA, Ellison DW. cIMPACT-NOW update 6: new entity and diagnostic principle recommendations of the cIMPACT-Utrecht meeting on future CNS tumor classification and grading. Brain Pathol. 2020 Jul;30(4):844-856. doi: 10.1111/bpa.12832. Epub 2020 Apr 19.

ReferenceCitation: Louis DN, Perry A, Reifenberger G, von Deimling A, Figarella-Branger D, Cavenee WK, Ohgaki H, Wiestler OD, Kleihues P, Ellison DW. The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathol. 2016 Jun;131(6):803-20. doi: 10.1007/s00401-016-1545-1. Epub 2016 May 9.

evidence: open (via free pdf)

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

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

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

unpaywall_oa_status: bronze

ReferenceCitation: Parker M, Mohankumar KM, Punchihewa C, Weinlich R, Dalton JD, Li Y, Lee R, Tatevossian RG, Phoenix TN, Thiruvenkatam R, White E, Tang B, Orisme W, Gupta K, Rusch M, Chen X, Li Y, Nagahawhatte P, Hedlund E, Finkelstein D, Wu G, Shurtleff S, Easton J, Boggs K, Yergeau D, Vadodaria B, Mulder HL, Becksfort J, Gupta P, Huether R, Ma J, Song G, Gajjar A, Merchant T, Boop F, Smith AA, Ding L, Lu C, Ochoa K, Zhao D, Fulton RS, Fulton LL, Mardis ER, Wilson RK, Downing JR, Green DR, Zhang J, Ellison DW, Gilbertson RJ. C11orf95-RELA fusions drive oncogenic NF-kappaB signalling in ependymoma. Nature. 2014 Feb 27;506(7489):451-5. doi: 10.1038/nature13109. Epub 2014 Feb 19. Erratum In: Nature. 2014 Apr 24;508(7497):554. Becksford, Jared [corrected to Becksfort, Jared].

ReferenceCitation: Panwalkar P, Clark J, Ramaswamy V, Hawes D, Yang F, Dunham C, Yip S, Hukin J, Sun Y, Schipper MJ, Chavez L, Margol A, Pekmezci M, Chung C, Banda A, Bayliss JM, Curry SJ, Santi M, Rodriguez FJ, Snuderl M, Karajannis MA, Saratsis AM, Horbinski CM, Carret AS, Wilson B, Johnston D, Lafay-Cousin L, Zelcer S, Eisenstat D, Silva M, Scheinemann K, Jabado N, McNeely PD, Kool M, Pfister SM, Taylor MD, Hawkins C, Korshunov A, Judkins AR, Venneti S. Immunohistochemical analysis of H3K27me3 demonstrates global reduction in group-A childhood posterior fossa ependymoma and is a powerful predictor of outcome. Acta Neuropathol. 2017 Nov;134(5):705-714. doi: 10.1007/s00401-017-1752-4. Epub 2017 Jul 21.

ReferenceCitation: Pajtler KW, Witt H, Sill M, Jones DT, Hovestadt V, Kratochwil F, Wani K, Tatevossian R, Punchihewa C, Johann P, Reimand J, Warnatz HJ, Ryzhova M, Mack S, Ramaswamy V, Capper D, Schweizer L, Sieber L, Wittmann A, Huang Z, van Sluis P, Volckmann R, Koster J, Versteeg R, Fults D, Toledano H, Avigad S, Hoffman LM, Donson AM, Foreman N, Hewer E, Zitterbart K, Gilbert M, Armstrong TS, Gupta N, Allen JC, Karajannis MA, Zagzag D, Hasselblatt M, Kulozik AE, Witt O, Collins VP, von Hoff K, Rutkowski S, Pietsch T, Bader G, Yaspo ML, von Deimling A, Lichter P, Taylor MD, Gilbertson R, Ellison DW, Aldape K, Korshunov A, Kool M, Pfister SM. Molecular Classification of Ependymal Tumors across All CNS Compartments, Histopathological Grades, and Age Groups. Cancer Cell. 2015 May 11;27(5):728-43. doi: 10.1016/j.ccell.2015.04.002.

ReferenceCitation: Pajtler KW, Wen J, Sill M, Lin T, Orisme W, Tang B, Hubner JM, Ramaswamy V, Jia S, Dalton JD, Haupfear K, Rogers HA, Punchihewa C, Lee R, Easton J, Wu G, Ritzmann TA, Chapman R, Chavez L, Boop FA, Klimo P, Sabin ND, Ogg R, Mack SC, Freibaum BD, Kim HJ, Witt H, Jones DTW, Vo B, Gajjar A, Pounds S, Onar-Thomas A, Roussel MF, Zhang J, Taylor JP, Merchant TE, Grundy R, Tatevossian RG, Taylor MD, Pfister SM, Korshunov A, Kool M, Ellison DW. Molecular heterogeneity and CXorf67 alterations in posterior fossa group A (PFA) ependymomas. Acta Neuropathol. 2018 Aug;136(2):211-226. doi: 10.1007/s00401-018-1877-0. Epub 2018 Jun 16.

ReferenceCitation: Siegfried A, Rousseau A, Maurage CA, Pericart S, Nicaise Y, Escudie F, Grand D, Delrieu A, Gomez-Brouchet A, Le Guellec S, Franchet C, Boetto S, Vinchon M, Sol JC, Roux FE, Rigau V, Bertozzi AI, Jones DTW, Figarella-Branger D, Uro-Coste E. EWSR1-PATZ1 gene fusion may define a new glioneuronal tumor entity. Brain Pathol. 2019 Jan;29(1):53-62. doi: 10.1111/bpa.12619. Epub 2018 Jul 13.

ReferenceCitation: Siegfried A, Masliah-Planchon J, Roux FE, Larrieu-Ciron D, Pierron G, Nicaise Y, Gambart M, Catalaa I, Pericart S, Dubucs C, Mohand-Oumoussa B, Tirode F, Bourdeaut F, Uro-Coste E. Brain tumor with an ATXN1-NUTM1 fusion gene expands the histologic spectrum of NUTM1-rearranged neoplasia. Acta Neuropathol Commun. 2019 Dec 30;7(1):220. doi: 10.1186/s40478-019-0870-8. No abstract available.

ReferenceCitation: Kermany DS, Goldbaum M, Cai W, Valentim CCS, Liang H, Baxter SL, McKeown A, Yang G, Wu X, Yan F, Dong J, Prasadha MK, Pei J, Ting MYL, Zhu J, Li C, Hewett S, Dong J, Ziyar I, Shi A, Zhang R, Zheng L, Hou R, Shi W, Fu X, Duan Y, Huu VAN, Wen C, Zhang ED, Zhang CL, Li O, Wang X, Singer MA, Sun X, Xu J, Tafreshi A, Lewis MA, Xia H, Zhang K. Identifying Medical Diagnoses and Treatable Diseases by Image-Based Deep Learning. Cell. 2018 Feb 22;172(5):1122-1131.e9. doi: 10.1016/j.cell.2018.02.010.

ReferenceCitation: Coudray N, Ocampo PS, Sakellaropoulos T, Narula N, Snuderl M, Fenyo D, Moreira AL, Razavian N, Tsirigos A. Classification and mutation prediction from non-small cell lung cancer histopathology images using deep learning. Nat Med. 2018 Oct;24(10):1559-1567. doi: 10.1038/s41591-018-0177-5. Epub 2018 Sep 17.

ReferenceCitation: Vahadane A, Peng T, Sethi A, Albarqouni S, Wang L, Baust M, Steiger K, Schlitter AM, Esposito I, Navab N. Structure-Preserving Color Normalization and Sparse Stain Separation for Histological Images. IEEE Trans Med Imaging. 2016 Aug;35(8):1962-71. doi: 10.1109/TMI.2016.2529665. Epub 2016 Apr 27.

ReferenceCitation: Ouyang W, Mueller F, Hjelmare M, Lundberg E, Zimmer C. ImJoy: an open-source computational platform for the deep learning era. Nat Methods. 2019 Dec;16(12):1199-1200. doi: 10.1038/s41592-019-0627-0. No abstract available.

ReferenceCitation: Moons KG, Altman DG, Vergouwe Y, Royston P. Prognosis and prognostic research: application and impact of prognostic models in clinical practice. BMJ. 2009 Jun 4;338:b606. doi: 10.1136/bmj.b606. No abstract available.

ReferenceCitation: Deist TM, Dankers FJWM, Valdes G, Wijsman R, Hsu IC, Oberije C, Lustberg T, van Soest J, Hoebers F, Jochems A, El Naqa I, Wee L, Morin O, Raleigh DR, Bots W, Kaanders JH, Belderbos J, Kwint M, Solberg T, Monshouwer R, Bussink J, Dekker A, Lambin P. Machine learning algorithms for outcome prediction in (chemo)radiotherapy: An empirical comparison of classifiers. Med Phys. 2018 Jul;45(7):3449-3459. doi: 10.1002/mp.12967. Epub 2018 Jun 13. Erratum In: Med Phys. 2019 Feb;46(2):1080-1087.

ReferenceCitation: Cozzi L, Dinapoli N, Fogliata A, Hsu WC, Reggiori G, Lobefalo F, Kirienko M, Sollini M, Franceschini D, Comito T, Franzese C, Scorsetti M, Wang PM. Radiomics based analysis to predict local control and survival in hepatocellular carcinoma patients treated with volumetric modulated arc therapy. BMC Cancer. 2017 Dec 6;17(1):829. doi: 10.1186/s12885-017-3847-7.

ReferenceCitation: Collins GS, Reitsma JB, Altman DG, Moons KG. Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD statement. BMJ. 2015 Jan 7;350:g7594. doi: 10.1136/bmj.g7594.

ReferenceCitation: Royston P, Sauerbrei W. A new measure of prognostic separation in survival data. Stat Med. 2004 Mar 15;23(5):723-48. doi: 10.1002/sim.1621.

ReferenceCitation: Heagerty PJ, Zheng Y. Survival model predictive accuracy and ROC curves. Biometrics. 2005 Mar;61(1):92-105. doi: 10.1111/j.0006-341X.2005.030814.x.

ReferenceCitation: De Bin R, Sauerbrei W, Boulesteix AL. Investigating the prediction ability of survival models based on both clinical and omics data: two case studies. Stat Med. 2014 Dec 30;33(30):5310-29. doi: 10.1002/sim.6246. Epub 2014 Jul 9.

ReferenceCitation: Laprie A, Ken S, Filleron T, Lubrano V, Vieillevigne L, Tensaouti F, Catalaa I, Boetto S, Khalifa J, Attal J, Peyraga G, Gomez-Roca C, Uro-Coste E, Noel G, Truc G, Sunyach MP, Magne N, Charissoux M, Supiot S, Bernier V, Mounier M, Poublanc M, Fabre A, Delord JP, Cohen-Jonathan Moyal E. Dose-painting multicenter phase III trial in newly diagnosed glioblastoma: the SPECTRO-GLIO trial comparing arm A standard radiochemotherapy to arm B radiochemotherapy with simultaneous integrated boost guided by MR spectroscopic imaging. BMC Cancer. 2019 Feb 21;19(1):167. doi: 10.1186/s12885-019-5317-x.

ReferenceCitation: Khalifa J, Tensaouti F, Lotterie JA, Catalaa I, Chaltiel L, Benouaich-Amiel A, Gomez-Roca C, Noel G, Truc G, Peran P, Berry I, Sunyach MP, Charissoux M, Johnson C, Cohen-Jonathan Moyal E, Laprie A. Do perfusion and diffusion MRI predict glioblastoma relapse sites following chemoradiation? J Neurooncol. 2016 Oct;130(1):181-192. doi: 10.1007/s11060-016-2232-8. Epub 2016 Aug 8.

ReferenceCitation: Laprie A, Catalaa I, Cassol E, McKnight TR, Berchery D, Marre D, Bachaud JM, Berry I, Moyal EC. Proton magnetic resonance spectroscopic imaging in newly diagnosed glioblastoma: predictive value for the site of postradiotherapy relapse in a prospective longitudinal study. Int J Radiat Oncol Biol Phys. 2008 Mar 1;70(3):773-81. doi: 10.1016/j.ijrobp.2007.10.039.

lead_sponsor: Institut Claudius Regaud

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

collaborators: Assistance Publique Hopitaux De Marseille

appel_a_projets: PRTK

region: Occitanie

nom_etablissement: INSTITUT CLAUDIUS REGAUD ONCOPOLE

type_etablissement: CLCC

acronyme: EPENDYMOMICS

titre: Approche multiomique de la radiorésistance des ependymomes de l'enfant et adolescent.

discipline_principale: cancer


type: Other Grant/Funding Number

title: Impact of a Therapeutic Educational Programme for Alzheimer's Disease Patients and Their Caregiver in Community Dwelling, on the AD Patient's Quality of Life

acronym: THERAD

summary: Therapeutic education expands in Alzheimer's Disease management in France. Several studies revealed a positive impact on caregiver's burden and/or quality of life. The purpose of this study, is to determine whether a therapeutic educational programme for both AD patients and primary caregivers, in community dwelling, improves patient's quality of life.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Villars H, Cantet C, de Peretti E, Perrin A, Soto-Martin M, Gardette V. Impact of an educational programme on Alzheimer's disease patients' quality of life: results of the randomized controlled trial THERAD. Alzheimers Res Ther. 2021 Sep 12;13(1):152. doi: 10.1186/s13195-021-00896-3.

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 pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceType: derived

ReferenceCitation: Villars H, Gardette V, Perrin A, Hein C, Elmalem S, de Peretti E, Zueras A, Vellas B, Nourhashemi F. Study protocol: Randomised controlled trial to evaluate the impact of an educational programme on Alzheimer's disease patients' quality of life. Alzheimers Res Ther. 2014 Oct 27;6(5-8):66. doi: 10.1186/s13195-014-0066-1. eCollection 2014.

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

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Springer

lead_sponsor: University Hospital, Toulouse

location_facility: CHU de Toulouse, Hôtel-Dieu, 2 rue Viguerie

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Completed


title: Safety and Efficacy in a ReAl-Life Study in Patients With Haemophilia Treated wIth NovoEight® for Surgery

acronym: SERAPHINE

summary: the aim of the SERAPHINE study is to gather data stemming from the French research database BERHLINGO (= Base d'Etude et de Recherche en Hémostase pour Les Investigateurs du Grand-Ouest, i.e. Database for Research on Hemostasis for the Investigators of Western France), in order to get a detailed report about the therapeutic management and use of turoctocog alfa (NovoEight®) in surgery in pwHA (Patient with inherited Hemophilia A).

study_start_date_type: Actual

study_type: Observational

time_perspective: Retrospective

ipd_sharing: Undecided

lead_sponsor: Nantes University Hospital

location_facility:
CH Le Mans
CHU de Nantes
CHU Angers

intervention_type: Other


title: A Randomized Trial to Evaluate Effectiveness of Acetazolamide in COPD Patients Developing Metabolic Alkalosis During Invasive Mechanical Ventilation

acronym: DIABOLO

summary: The purpose of this study is to determine whether acetazolamide are effective to reduce the length of mechanical ventilation in decompensated Chronic Obstructive Pulmonary Disease (COPD) patients developing pure or mixed metabolic alkalosis.

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Heming N, Faisy C, Urien S. Population pharmacodynamic model of bicarbonate response to acetazolamide in mechanically ventilated chronic obstructive pulmonary disease patients. Crit Care. 2011;15(5):R213. doi: 10.1186/cc10448. Epub 2011 Sep 14.

ReferenceCitation: Chang WT, Thayer DW. The cellulase system of a Cytophaga species. Can J Microbiol. 1977 Sep;23(9):1285-92. doi: 10.1139/m77-192.

ReferenceCitation: Faisy C, Meziani F, Planquette B, Clavel M, Gacouin A, Bornstain C, Schneider F, Duguet A, Gibot S, Lerolle N, Ricard JD, Sanchez O, Djibre M, Ricome JL, Rabbat A, Heming N, Urien S, Esvan M, Katsahian S; DIABOLO Investigators. Effect of Acetazolamide vs Placebo on Duration of Invasive Mechanical Ventilation Among Patients With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial. JAMA. 2016 Feb 2;315(5):480-8. doi: 10.1001/jama.2016.0019.

oa_host_type: publisher

repositories_concat: closed

publisher_dissemination: American Medical Association

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France

location_facility: Clinical Research Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris

intervention_type: Drug


title: A Transversal Study for the French Validation of Two Assessment Tools of Gambling Related Cognitions.

summary: This study is divided into two stages. In the first stage, students from the University of Nantes completed the two assessment tools of gambling related cognitions (GABS : Gambling Attitudes and Beliefs Survey ; GRCS : Gambling Related Cognitions Scale), and a reference tool for gambling problem severity (SOGS : South Oaks Gambling Screen). In the second stage, consecutive pathological gamblers seeking treatment at the University Hospital of Nantes completed the three questionnaires. Only questionnaires from participants who reported gambling at least one time in the past year were kept for analyses.Responses of students gamblers and pathological gamblers presenting for treatment have been compiled for analysis.The main objective of the study is to validate the French adaptations of the GABS and the GRCS, and to explore their psychometric properties and structures.

time_perspective: Prospective


type: Registry Identifier

title: National, Multicenter, Non-interventional, Prospective Study to Explore the Quality of Life of Patients With Severe Asthma Starting Treatment With Dupilumab (Dupixent®) in a Real-world Setting

acronym: PROVERB

summary:
Primary Objective:

- To describe dupilumab health-related quality of life (HRQoL) effectiveness at 52 weeks compared to baseline.

Secondary Objectives:

To describe dupilumab HRQoL effectiveness at 12 and 24 weeks compared to baseline.
To assess the safety during the year of treatment in a real-world setting.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: Yes

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

lead_sponsor: Sanofi

lead_sponsor_type: industriel

status_simplified: Ongoing


title: CD160 Expression in Retinal Vessels is Associated With Retinal Neovascular Diseases

summary:
The aims of this study were

to analyze CD160 expression in both normal and pathological eyes from human adults
to evaluate association between CD160 presence on endothelial cells from blood vessels and retinal vascular disease

ReferenceCitation: Henry A, Boulagnon-Rombi C, Menguy T, Giustiniani J, Garbar C, Mascaux C, Labrousse M, Milas C, Barbe C, Bensussan A, Durlach V, Arndt C. CD160 Expression in Retinal Vessels Is Associated With Retinal Neovascular Diseases. Invest Ophthalmol Vis Sci. 2018 Jun 1;59(7):2679-2686. doi: 10.1167/iovs.18-24021.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Association for Research in Vision and Ophthalmology (ARVO)

lead_sponsor: CHU de Reims


title: Prediction of Appearance of Late Cutaneous Side Effects After RadioTherapy

acronym: PAESCART

summary: Search for blood predictive marker (s) for cutaneous radiosensitivity

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Centre Francois Baclesse

intervention_type: Diagnostic Test


title: Cross-cultural and Psychometric Validation Version of the Xerostomia Inventory Into French Language

acronym: XIvf

summary: The main objective of this study is to achieve cross-cultural and psychometric validation of the Xerostomia Inventory initially developed in English language into French Language. This will be achieved in two stages: First, cross-cultural validation, and a second, psychometric validation The cross-cultural validation will be performed according to the methodology of the Institute for Work and Health, according to the recommended six phases. In a second step, the psychometric validation will be done using longitudinal study. Indeed, an observational, longitudinal, and prospective study will be set up. Analysis of the results will help define the feasibility and acceptability of the tool, its validity (content validity, perceived validity, construct validity, concurrent validity, and discriminant validity), its reliability (internal consistency and reproducibility over time). Longitudinal follow-up of patients is expected to also assess the predictive validity and responsiveness.

status: Unknown status

status_simplified: Unknown


title: Tumor Mutation Profiling in Bile Samples From Patients With Biliary Strictures Related to Pancreatico-biliary Cancers

acronym: ONCOBIL

summary:
The differential diagnosis between benign and malignant bile duct strictures is a difficult and demanding task for clinicians. Clinical, biochemical, and radiological characteristics of malignant biliary strictures are non-specific and tissue diagnosis is difficult to obtain preoperatively. For this reason, there is a need for the development of new diagnostic modalities. Of particular interest is the quest of tumor markers secreted or shed in bile by tumor cells developing in the biliary tract.

In addition, patient's tumor molecular profile is the basis for selecting personalized therapy. Cholangiocarcinomas are characterized by a large genetic heterogeneity. The most frequent mutations are TP53, KRAS, BRAF, EGFR, MET, NRAS, PIK3CA, ERBB2, SMAD4, FBXW7, ARID1A, PBRM1, BAP1 et IDH1/2. In the case of pancreatic cancers, the most frequent are KRAS mutation detected in 90 % of the patients and CDKN2A, SMAD4, TGFBR1, TGFBR2, ATM, BRCA2, MLL2, MLL3, KDM6A, ARID1A, ARID1B, SMARC1, GNAS and RNF43 mutations.

It is well established that KRAS and P53 mutations can be detected in bile samples from patients with biliary strictures related to cholangiocarcinoma and cancer of the head of the pancreas. The main objective is to determine if bile sample analysis from patients with malignant biliary stricture may allow to identify tumor mutation profile and determine tumor genotype. A secondary objective is to evaluate the diagnostic value of Vascular Endothelial Growth Factor (VEGF) and metallo-proteinases (MMPs) levels in bile samples.

Tumor genotyping will be performed in bile samples (supernatant and cell pellet) and tumor tissues in a series of 10 patients surgically treated for malignant biliary stricture related to cholangiocarcinoma or cancer of the head of the pancreas. The biochemical markers, VEGF and MMPs, will be assessed in bile samples obtained during endoscopic retrograde cholangiopancreatography in 50 patients with malignant biliary stricture and 50 patients treated for benign biliary diseases.

intervention_type: Biological


title: Markers of Vascular Aging and Coronary Syndrome

acronym: MAVASCOR

summary:
Atherosclerosis and aging are associated to the raise of biochemical alterations of proteins grouped under the name of " non-enzymatic post-translational modifications ". They often correspond to the irreversible binding of glucose or other oses (glycation) or urea derivatives (carbamylation) on proteins and lead to the formation of complex compounds (post-translational modifications derived products, PTMD) that can accumulate in tissues and be responsible for deleterious effects. The specific role of these compounds in the pathophysiology of aging and atherosclerosis remains unknown, as are the molecular and cellular mechanisms implicated.

This project is based on the hypothesis that non-enzymatic post-translational modifications may cause changes in the genesis of complication of coronary atherosclerosis and that PTMD could therefore constitute relevant biomarkers in this specific clinical situation.

To explore these potential new biomarkers, the investigators designed a study in patients having experienced an acute coronary syndrome and followed during a year. The concentrations of PTMD assayed at 0, 1, 3, 12 months, will be correlated to clinical (severity and evolution) and paraclinical (cutaneous autofluorescence) data and the effect of cardiac rehabilitation will be assessed.

This should help to identify new (and non-traditional) biomarkers of coronary heart disease and determine some of the implicated pathophysiological mechanisms.

primary_purpose: Basic Science


title: Comparison of Lung Concentrations of Ceftazidime Administered by Continuous Versus Intermittent Infusion in Patients With Ventilator-associated Pneumonia

acronym: CEFTALC

summary: Ceftazidime is a beta-lactam compound that exerts a time-dependent bactericidal effect. Numerous arguments are in favor of continuous administration of ceftazidime, both for reasons of clinical efficacy and to preserve bacteriological mutation. The investigators report a prospective, single-center, parallel-group, randomized, controlled trial comparing two modes of administration of ceftazidime, namely, continuous administration (loading dose of 20 mg/kg of body weight followed by 60 mg/kg/day) versus intermittent administration (20 mg/kg over 30 min every 8 h) in 34 patients with ventilator-associated pneumonia due to Gram-negative bacilli. The study was performed over 48 h with 13 and 18 assessments of serum ceftazidime in the continuous-infusion group (group A) and the intermittent-fusion group (group B), respectively. Bronchoalveolar lavage (BAL) was performed at steady state in both groups at 44 h to determine ceftazidime levels in the epithelial lining fluid. The investigators chose a predefined threshold of 20 mg/liter for serum concentrations of ceftazidime because of ecological conditions in our center.

ReferenceCitation: Cousson J, Floch T, Guillard T, Vernet V, Raclot P, Wolak-Thierry A, Jolly D. Lung concentrations of ceftazidime administered by continuous versus intermittent infusion in patients with ventilator-associated pneumonia. Antimicrob Agents Chemother. 2015 Apr;59(4):1905-9. doi: 10.1128/AAC.04232-14. Epub 2015 Jan 12.

oa_colors: green other

publisher_dissemination: American Society for Microbiology


title: Prevalence, Characterization and Risk Factors of Acquiring Qnr Genes in Extended Spectrum Beta-lactamase Producing Enterobacteriaceae Isolated in East Inter-region.

summary:
Enterobacteriaceae are bacteria of the gastrointestinal tract which are also the most frequently involved in bacterial infections, especially urinary tract infections. Because of their presence in the gut, these bacteria are the most exposed to antibiotic treatment administered to patients.

Therefore, many antibiotic resistance mechanisms are observed in some of them. Quinolone antibiotics are often used because of their distribution in the body, of the great number of bacterial species that are sensitive to these antibiotics and the possibility to give oral treatments.

For a long time no transferable resistance gene to quinolones from one bacterium to another had been observed. This phenomenon has been demonstrated in 1998 in a bacterium of the Klebsiella pneumoniae species carrying a qnrA gene which encodes a protein that protects the target of the antibiotic in the bacteria. Since several genes have been observed. These genes reduce the sensitivity of the bacteria without ever reach detectable resistance levels on the tests commonly used in the laboratory. However, these genes are often found among enterobacteria in combination with other mechanisms of resistance to other classes of antibiotics including beta-lactam antibiotics that are widely used antibiotics.

Moreover, it is considered that quinolone administration to bacteria carrying these qnr genes could promote the emergence of mutants resistant to quinolones to a more high-level. That furthers multiresistance emergence when the bacteria is already resistant to beta-lactam antibiotics.

The aim of this study performed between April 2008 and March 2009 was to collect strains resistant to beta-lactams because of the production of enzymes, called extended-spectrum beta-lactamase to determine quinolone resistance gene frequency in these bacteria.

Meanwhile, control patients were selected to seek the emergence of these genes risk factors.

The clinical study failed to identify specific risk factors, however, the biological study enhanced the knowledge on this issue with the setting-up of a method for rapid detection of these plasmidic mediated quinolones resistance genes and the description a new plasmid containing a qnr gene, qnrD, whose study is still ongoing.


title: Frail Elderly Subjects: Inhospital Pathways and Adverse Outcome After Hospitalisation Via Emergency Department

acronym: SAFES Cohort

summary: This was a prospective multicenter cohort study of elderly people admitted to medical wards via emergency departments. Subjects were followed up to 36 months. It aimed to study the inhospital pathways and adverse geriatric outcomes. In all, 1306 subjects were included : 85+/-5 years, and mainly women (65%).

ReferenceCitation: Tardieu E, Mahmoudi R, Novella JL, Oubaya N, Blanchard F, Jolly D, Drame M. [External validation of the short emergency geriatric assessment (SEGA) instrument on the SAFES cohort]. Geriatr Psychol Neuropsychiatr Vieil. 2016 Mar;14(1):49-55. doi: 10.1684/pnv.2016.0592. French.

oa_host_type: closed

publisher_dissemination: John Libbey Eurotext

ReferenceCitation: de Boissieu P, Mahmoudi R, Hentzien M, Toquet S, Novella JL, Blanchard F, Jolly D, Drame M. Predictors of Long-Term Mortality in Oldest Old Patients (90+) Hospitalized to Medical Wards via the Emergency Department: The SAFES Cohort. J Nutr Health Aging. 2015 Jun;19(6):702-7. doi: 10.1007/s12603-015-0515-y.

ReferenceCitation: Lang PO, Mahmoudi R, Novella JL, Tardieu E, Bertholon LA, Nazeyrollas P, Blanchard F, Jolly D, Drame M. Is obesity a marker of robustness in vulnerable hospitalized aged populations? Prospective, multicenter cohort study of 1 306 acutely ill patients. J Nutr Health Aging. 2014 Jan;18(1):66-74. doi: 10.1007/s12603-013-0352-9.

ReferenceCitation: Narbey D, Jolly D, Mahmoudi R, Trenque T, Blanchard F, Novella JL, Drame M. Relationship between anticholinergic drug use and one-year outcome among elderly people hospitalised in medical wards via emergency department: the SAFES cohort study. J Nutr Health Aging. 2013 Sep;17(9):766-71. doi: 10.1007/s12603-013-0349-4.

ReferenceCitation: Drame M, Lang PO, Novella JL, Narbey D, Mahmoudi R, Laniece I, Somme D, Gauvain JB, Heitz D, Voisin T, de Wazieres B, Gonthier R, Ankri J, Saint-Jean O, Jeandel C, Couturier P, Blanchard F, Jolly D. Six-month outcome of elderly people hospitalized via the emergency department: the SAFES cohort. Rev Epidemiol Sante Publique. 2012 Jun;60(3):189-96. doi: 10.1016/j.respe.2011.11.004. Epub 2012 May 16.

ReferenceCitation: Dhaussy G, Drame M, Jolly D, Mahmoudi R, Barbe C, Kanagaratnam L, Nazeyrollas P, Blanchard F, Novella JL; SAFES Group. Is health-related quality of life an independent prognostic factor for 12-month mortality and nursing home placement among elderly patients hospitalized via the emergency department? J Am Med Dir Assoc. 2012 Jun;13(5):453-8. doi: 10.1016/j.jamda.2011.10.002. Epub 2011 Nov 13.

ReferenceCitation: Drame M, Novella JL, Jolly D, Laniece I, Somme D, Heitz D, Gauvain JB, Voisin T, De Wazieres B, Gonthier R, Jeandel C, Couturier P, Saint-Jean O, Ankri J, Blanchard F, Lang PO. Rapid cognitive decline, one-year institutional admission and one-year mortality: analysis of the ability to predict and inter-tool agreement of four validated clinical frailty indexes in the SAFEs cohort. J Nutr Health Aging. 2011 Aug;15(8):699-705. doi: 10.1007/s12603-011-0164-8.

ReferenceCitation: Lang PO, Drame M, Mahmoudi R, Jolly D, Laniece I, Saint-Jean O, Somme D, Heitz D, Gauvain JB, Voisin T, de Wazieres B, Gonthier R, Jeandel C, Couturier P, Ankri J, Blanchard F, Novella JL. [Frailty: learnings from the SAFEs cohort study and future perspectives for the research]. Geriatr Psychol Neuropsychiatr Vieil. 2011 Jun;9(2):135-49. doi: 10.1684/pnv.2011.0279. French.

ReferenceCitation: Drame M, Fierobe F, Lang PO, Jolly D, Boyer F, Mahmoudi R, Somme D, Laniece I, Heitz D, Gauvain JB, Voisin T, De Wazieres B, Gonthier R, Ankri J, Saint-Jean O, Couturier P, Jeandel C, Blanchard F, Novella JL. Predictors of institution admission in the year following acute hospitalisation of elderly people. J Nutr Health Aging. 2011 May;15(5):399-403. doi: 10.1007/s12603-011-0004-x.

ReferenceCitation: Drame M, Lang PO, Jolly D, Narbey D, Mahmoudi R, Laniece I, Somme D, Gauvain JB, Heitz D, Voisin T, de Wazieres B, Gonthier R, Ankri J, Saint-Jean O, Jeandel C, Couturier P, Blanchard F, Novella JL. Nursing home admission in elderly subjects with dementia: predictive factors and future challenges. J Am Med Dir Assoc. 2012 Jan;13(1):83.e17-20. doi: 10.1016/j.jamda.2011.03.002. Epub 2011 Apr 13.

ReferenceCitation: Lang PO, Drame M, Jolly D, Novella JL, Blanchard F, Michel JP. [What do we learn from the SAFEs cohort to fit hospital care models for aged inpatient?]. Presse Med. 2010 Nov;39(11):1132-42. doi: 10.1016/j.lpm.2010.05.009. Epub 2010 Jul 1. French.

ReferenceCitation: Somme D, Lazarovici C, Drame M, Blanc P, Lang PO, Gauvain JB, Voisin T, Gonthier R, De Wazieres B, Jeandel C, Couturier P, Blanchard F, Saint-Jean O. The geriatric patient: use of acute geriatrics units in the emergency care of elderly patients in France. Arch Gerontol Geriatr. 2011 Jan-Feb;52(1):40-5. doi: 10.1016/j.archger.2010.01.018. Epub 2010 Mar 3.

ReferenceCitation: Lang PO, Zekry D, Michel JP, Drame M, Novella JL, Jolly D, Blanchard F. Early markers of prolonged hospital stay in demented inpatients: a multicentre and prospective study. J Nutr Health Aging. 2010 Feb;14(2):141-7. doi: 10.1007/s12603-009-0182-y.

ReferenceCitation: Drame M, Dia PA, Jolly D, Lang PO, Mahmoudi R, Schwebel G, Kack M, Debart A, Courtaigne B, Laniece I, Blanchard F, Novella JL. [Factors predictive of long-term mortality in patients aged 75 years or older hospitalized from the emergency department: the SAFES cohort]. Presse Med. 2009 Jul-Aug;38(7-8):1068-75. doi: 10.1016/j.lpm.2009.01.019. Epub 2009 Apr 18. French.

ReferenceCitation: Viatonou S, Drame M, Jolly D, Morrone I, Lang PO, Voisin T, Boyer FC, Schwebel G, Somme D, Blanchard F, Novella JL. Predictors of rapid cognitive decline among demented subjects aged 75 or more: ('Sujet Age Fragile--Evaluation et Suivi' Cohort-SAFES). Int J Geriatr Psychiatry. 2009 Jul;24(7):709-15. doi: 10.1002/gps.2183.

ReferenceCitation: Prudent M, Drame M, Jolly D, Trenque T, Parjoie R, Mahmoudi R, Lang PO, Somme D, Boyer F, Laniece I, Gauvain JB, Blanchard F, Novella JL. Potentially inappropriate use of psychotropic medications in hospitalized elderly patients in France: cross-sectional analysis of the prospective, multicentre SAFEs cohort. Drugs Aging. 2008;25(11):933-46. doi: 10.2165/0002512-200825110-00004.

ReferenceCitation: Drame M, Novella JL, Lang PO, Somme D, Jovenin N, Laniece I, Couturier P, Heitz D, Gauvain JB, Voisin T, De Wazieres B, Gonthier R, Ankri J, Jeandel C, Saint-Jean O, Blanchard F, Jolly D. Derivation and validation of a mortality-risk index from a cohort of frail elderly patients hospitalised in medical wards via emergencies: the SAFES study. Eur J Epidemiol. 2008;23(12):783-91. doi: 10.1007/s10654-008-9290-y. Epub 2008 Oct 21.

ReferenceCitation: Drame M, Jovenin N, Novella JL, Lang PO, Somme D, Laniece I, Voisin T, Blanc P, Couturier P, Gauvain JB, Blanchard F, Jolly D. Predicting early mortality among elderly patients hospitalised in medical wards via emergency department: the SAFES cohort study. J Nutr Health Aging. 2008 Oct;12(8):599-604. doi: 10.1007/BF02983207.

ReferenceCitation: Laniece I, Couturier P, Drame M, Gavazzi G, Lehman S, Jolly D, Voisin T, Lang PO, Jovenin N, Gauvain JB, Novella JL, Saint-Jean O, Blanchard F. Incidence and main factors associated with early unplanned hospital readmission among French medical inpatients aged 75 and over admitted through emergency units. Age Ageing. 2008 Jul;37(4):416-22. doi: 10.1093/ageing/afn093. Epub 2008 May 16.

ReferenceCitation: Lang PO, Meyer N, Heitz D, Drame M, Jovenin N, Ankri J, Somme D, Novella JL, Gauvain JB, Couturier P, Laniece I, Voisin T, de Wazieres B, Gonthier R, Jeandel C, Jolly D, Saint-Jean O, Blanchard F. Loss of independence in Katz's ADL ability in connection with an acute hospitalization: early clinical markers in French older people. Eur J Epidemiol. 2007;22(9):621-30. doi: 10.1007/s10654-007-9150-1. Epub 2007 Jul 25.

ReferenceCitation: Lang PO, Heitz D, Meyer N, Drame M, Jovenin N, Ankri J, Somme D, Novella JL, Gauvain JB, Colvez A, Couturier P, Laniece I, Voisin T, de Wazieres B, Gonthier R, Jeandel C, Jolly D, Saint-Jean O, Blanchard F. [Early indicators of prolonged hospitalization of the elderly: pilot study at Strasbourg University Hospital]. Presse Med. 2007 Mar;36(3 Pt 1):389-98. doi: 10.1016/j.lpm.2006.12.020. Epub 2007 Jan 17. French.

ReferenceCitation: Lang PO, Heitz D, Hedelin G, Drame M, Jovenin N, Ankri J, Somme D, Novella JL, Gauvain JB, Couturier P, Voisin T, De Waziere B, Gonthier R, Jeandel C, Jolly D, Saint-Jean O, Blanchard F. Early markers of prolonged hospital stays in older people: a prospective, multicenter study of 908 inpatients in French acute hospitals. J Am Geriatr Soc. 2006 Jul;54(7):1031-9. doi: 10.1111/j.1532-5415.2006.00767.x. Erratum In: J Am Geriatr Soc. 2006 Sep;54(9):1479-80.


title: ex Vivo Study of the Inflammatory Response Associated With Hidradenitis Suppurativa

summary:
The objective is to investigate ex vivo the inflammatory response in hidradenitis suppurativa (HS) (activation of an inflammasome, role of pro-inflammatory cytokines) in the skin of patients treated surgically for this disease.

The investigators hypothesize that Th17-derived cytokines, especially Interleukin (IL) IL-17, could serve as a relay in the inflammatory process leading to HS severity and recurrences.


title: Endometrial Cancer: Evaluation of Genetic Imbalances in the Carcinogenesis Process

summary:
Medical context:

Several molecular studies showed chromosomal alterations in patients with endometrial cancer, with gains in 1q, 19p, 19q, 8q, 10q and 10p and loss of 4q, 16q and 18q. Several genes of interest have been dentified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...). It is thus conceivable that like that enable genomic tools used in breast cancer today (Oncotype DX, MammaPrint), correlation between the tumor profile and life project in the case of cancer the endometrium could be done. A study is already underway at the Reims University Hospital with funding from the League against cancer and AOL in 2010 CHU Reims. It should identify the specific alterations of nosologic continuum of pathology and characterize areas of interest on the genome. To date, 39 patients with endometrial cancer and 15 patients with endometrial hyperplasia (patients 'cases') were included in the study. For this study, 10 patients exhibiting neither cancer nor endometrial hyperplasia were also included. Samples of these 10 patients 'witnesses' were pooled to serve as a reference for analyzing patients 'cases'.

objectives: In continuation of the study began in November 2009, refine the study of genomic imbalances highlighted hyperplasia and endometrial cancer by studying the in correlation between genomics and proteomics by immunohistochemical studies and analyzing the microsatellite instability.

To study the prognostic role of genetic factors in patients carriers of a disease endometrial (cancer or hyperplasia).

Material and methods :

Experimental Design: Cross-sectional study in inclusion prospective multi-center followed by a cohort study of patients 'cases'.

Population / patients: in total, it is planned to include 72 patients with hyperplasia or endometrial cancer (22 patients included in the pre-study part funded by the League against cancer 50 patients included in the scope of the study funded by the 2010 AOL Chu Reims).

Plan of investigation: the study includes two phases:

Sectional study:

The inclusion of 10 patients "witnesses" has already been completed in the first project.

During the consultation in the obstetrics and gynecology department of the Reims University Hospital and the surgical department of the institute Jean Godinot, terms and objectives of the study have been and will be presented to patients where cancer or hyperplasia endometrial was diagnosed by achieving endometrial biopsy.

If the patient agrees to participate in the study, the management of its pathology (hysterectomy, hysteroscopy and curettage resection) will not be changed.

The samples taken during the surgery were analyzed and will be as provided in the first research project. Tumor karyotype, DNA extraction are performed on each sample fresh. A comparative genomic hybridization is conducted using the DNAs thus obtained.

Additional analyzes (immunohistochemistry and analysis of microsatellite instability) will be performed on all samples already obtained and on future withdrawals.

intervention_type: Genetic


title: Laparoscopic Surgery and Abdominal Compliance Factors Including Neuromuscular Blocking Agents

acronym: COELIOCUR

summary: The objective of the study is to describe factors influencing abdominal compliance during laparoscopic surgery, including neuromuscular blocking agents (NMBA). The use of NMBA is randomized and blinded from the surgeons and the anesthesiologist. The abdominal compliance is measured by pressure/volume relationship.


title: Children Toxine Botulinum Detrusor Injection in Neurogenic Vesical Hyperactivity Syndrom: Non Inferiority Multicenter Controlled Therapeutic Study Between Two Reported Weight's Doses

acronym: TBIDE

summary: Detrusor hyperactivity is an urodynamic observation defined by involuntary detrusor contractions during the vesical filling. Within neurological bladders childs, especially related to spinal dysraphisms, this hyperactivity, associated or not with vesical compliance disorders, can involve a urinary incontinence obstructing social integration and possibly vesical pressure rise in the intra- potentially generating the high urinary tract lesions. Anticholinergic drugs possibly associated with a vesical draining constitute the treatment of first intention. In approximately 15 to 20% of the cases, intradetrusor iterative injections of type A Botulinum Toxin are proposed fault of satisfactory results. Largely used according to the European consensus of 2008 without AM, actual studies remain realized on small numbers with low level of proof. Posology remains discussed between pharmaceutical laboratories (derivative of the effective maximum amount per adult kg of weight) and weaker amounts used with clinical results.


title: Study of the Effects of the Bone Tissue on the Generation of Thrombine

summary: The research for a haemostasis and for an effective osseous healing are a major stake in oral surgery. The use of glues of fibrin, amplifying the polymerization of the fibrin during the haemostasis is known to reduce the risk of post-operative bruise and accelerate the healing but these glues present the inconvenience to be by-products of the blood, not devoid of infectious risk.


title: Clinical Outcomes After Arthroscopic Tenotomy or Tenodesis of the Long Head of the Biceps

summary:
Degenerative changes of the long head of the biceps brachii (LHB) are frequent and often associated with cuff tendinopathy. The function of the LHB in the shoulder is still controversial and uncertain, whereas its function in the elbow is certain. The biceps brachii is a flexor of the elbow and supinator of the forearm. Suppression of the pathologic long head of the biceps permits pain relief and is very reliable in the literature. Two options are available for the remaining tendon : simple tenotomy or tenodesis which consists to reattach the tendon to the humerus. Our hypothesis is that there is no difference in strength or endurance of the biceps brachii after tenotomy or tenodesis of the LHB. The aim of this study was to compare the strength and the endurance of the biceps brachii during supination and flexion after tenotomy or tenodesis of the LHB.

the investigators proposed a prospective and randomized study. All the patients treated in our department for an arthroscopic rotator cuff repair were included in this study after signed consent. Participants will complete isokinetic strength and endurance testing for elbow flexion and supination on the operative and nonoperative sides a minimum of 1 year after biceps tenotomy or tenodesis. The clinical evaluation included the range of motion measurement, Constant Score, Quick-DASH and SSV at 6 weeks, 3 months, 6 months and one year.

intervention_type: Procedure


title: Prevalence of Mutations of Glucocorticoid Receptors in Bilateral Adrenal Hyperplasia

acronym: MUTA-GR

summary: As the investigators observed a case of glucocorticoid mutation revealed by incidentally discovered bilateral adrenal nodular hyperplasia, it was postulated that this molecular anormality could be more frequent than previously described. To validate this hypothesis, it was decided to study 150 multicenter consecutive patients, presenting with incidentally discovered bilateral adrenal masses without clinical signs of Cushing's disease. In all these patients GR gene will be studied, mutations will be detected and described, functional disturbance will be tested. Usual polymorphisms will be described. Correlation between clinical signs, hormonal and morphological abnormalities and presence or absence of GR mutations will be searched.

ReferenceCitation: Vitellius G, Delemer B, Caron P, Chabre O, Bouligand J, Pussard E, Trabado S, Lombes M. Impaired 11beta-Hydroxysteroid Dehydrogenase Type 2 in Glucocorticoid-Resistant Patients. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5205-5216. doi: 10.1210/jc.2019-00800.

evidence: open (via free article)

publisher_dissemination: The Endocrine Society


title: Prevalence of Antiphospholipid Antibodies in Ankylosing Spondylitis: A Study of 80 Patients

acronym: ASAA

summary:
The main objective is to evaluate the prevalence of anti-phospholipid antibodies (APLA) in patients with ankylosing spondylitis (AS).

The secondary objectives are: (1) To determine whether the presence of these antibodies is symptomatic (thrombosis or not); (2) Identify a possible relationship between the presence of APLA and a particular form of SA (axial or peripheral); (3) To determine whether the presence of APLA is more frequent in patients receiving anti-tumor necrosis factor (TNF) alpha therapy.


title: Assessment of the Predictive Value of Fecal Calprotectin for the Outcome of Severe Alcoholic Hepatitis

acronym: CALPRO-HAA

summary:
Severe alcoholic hepatitis, defined by a "Maddrey discriminant function" above 32, is associated with significant short-term mortality. In patients with liver disease, studies have shown alterations of intestinal bacterial flora and an increase in intestinal permeability leading to bacterial translocation across the intestinal barrier. The mechanism involved may be an activation of intestinal macrophages with a local release of cytokines like interleukin-8 (IL-8).

Calprotectin is a protein present in large amounts in the cytosol of neutrophils. Its presence in feces is related to neutrophil migration in intestinal lumen. Thus, fecal calprotectin may be used as a marker of intestinal inflammation. There is evidence that fecal calprotectin levels are increased in cirrhotic patients dependent on the severity of the disease. The predictive value of fecal calprotectin for the outcome of severe alcoholic hepatitis has never been evaluated.

The main objective of this study was to determine if the initial level of fecal calprotectin and its variation after 7 days had a predictive value for the outcome of severe alcoholic hepatitis. Secondary objectives were to determine if fecal calprotectin concentration was correlated with blood concentration of Lipopolysaccharide (LPS) binding protein and predictive of infections.

primary_purpose: Other


title: Epidural Anesthesia Versus General Anesthesia for Elective Lumbar Disk Surgery in a Outpatient Basis

summary: Primary Goal: To compare the clinical outcomes of spinal anesthesia and general anesthesia in surgery for lumbar disc herniation.


title: Fragmentation of Elastin as a Biological Marker of Frailty and Impact in Tumor Progression in Elderly Patients With Cancer

acronym: AgElOn

summary:
The aim of the study is to evaluate frailty in patients aged ≥ 65 years with cancer. The elderly population is very heterogeneous, it is necessary to evaluate these elderly patients before treatment to assess the risk-benefit balance. To date, this assessment relies on subjective clinical methods often not optimal, and slow to implement. An innovative method of evaluation could be the determination of elastin peptides. Indeed, the rate of these peptides, which are linked to serious conditions associated with age, rising inexorably with age and dose could help determine more objectively the type of treatment to offer older patients.

Expected results : This study will allow better identification of the group of frail elderly through more relevant biological marker that clinical assessment, often subjective and not available within a period compatible with the treatment of newly diagnosed cancer. This biological assessment will also enable optimal management of elderly patients in particular by allowing the geriatrician better efficiency.


title: Interaction Emotion-cognition in the Study of Literal and Figurative Language in Schizophrenia and Bipolar Disorders: Behavioral and Electrophysiological Studies

acronym: ELISE

summary: The initial aim of the project was to gain an understanding of the comprehension of "language-oriented" emotions among schizophrenic and bipolar patients. By "language-oriented" emotions, the investigators mean the emotions that are conveyed by means of language, whether through the emotional valence of the words, the expression of an emotional state or emotional prosody. Although they involve different diagnostic categories, schizophrenic and bipolar disorders nevertheless share a number of symptoms, in particular in the emotional sphere, and do so to such an extent that the question of whether there may, at the clinical, cognitive and etiopathogenic levels, exist a continuum between these disorders is frequently raised. Taking this hypothesis of a clinical continuum as our starting point, the investigators explored the understanding of emotions contextualized by language in these two clinical populations, namely patients exhibiting schizophrenic and bipolar disorders. To these populations, the investigators also added the dimension of vulnerability in the form of non-clinical participants varying in terms of their traits of schizotypy and hypomania, thus orienting this project toward the early identification of cognitive-emotional markers and possibly also their prevention.

ReferenceCitation: Terrien S, Gobin P, Iakimova G, Coutte A, Thuaire F, Baltazart V, Mazzola-Pomietto P, Besche-Richard C. Electrophysiological correlates of emotional meaning in context in relation to facets of schizotypal personality traits: A dimensional study. Psychiatry Clin Neurosci. 2016 Mar;70(3):141-50. doi: 10.1111/pcn.12366. Epub 2015 Dec 22.

publisher_dissemination: Wiley

ReferenceCitation: Terrien S, Gobin P, Coutte A, Thuaire F, Iakimova G, Mazzola-Pomietto P, Besche-Richard C. Emotional Meaning in Context in Relation to Hypomanic Personality Traits: An ERP Study. PLoS One. 2015 Sep 22;10(9):e0138877. doi: 10.1371/journal.pone.0138877. eCollection 2015.

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

repository_normalized: HAL

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

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

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

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

publisher_dissemination: Public Library of Science

ReferenceCitation: Terrien S, Stefaniak N, Morvan Y, Besche-Richard C. Factor structure of the French version of the Hypomanic Personality Scale (HPS) in non-clinical young adults. Compr Psychiatry. 2015 Oct;62:105-13. doi: 10.1016/j.comppsych.2015.07.001. Epub 2015 Jul 8.

oa_host_type: repository

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

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

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: Elsevier


summary: The main objective of our study is to determine if the evaluation of ingesta of cancer patients by VAS (on the day of hospitalization) is able to predict the actual ingesta of patients during hospitalization (for patients malnourished, at risk of malnutrition or risk free).

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Monitoring Combining Neurostimulation and Ultrasound Guidance During the Realization of a Peripheral Nerve Block: Value of Objective Measurement of the Pressure of Injection of the Local Anesthetic

summary:
In clinical practice, local anesthetic injection pressure monitoring is performed manually or by a pressure transducer according to the availability of the equipment or preferences of clinicians. To date, no comparative study has measured the advantages of this measure during PNB.

The aim of this study is to evaluate injection pressure monitoring in order to reduce the risk of intraneural injection during peripheral nerve blocks

lead_sponsor: University Hospital, Montpellier


title: Linguistic, Anatomic/Metabolic and Biologic Characterisation of the Three Main Variants of Primary Progressive Aphasia : Towards the Rationale for Drug Trials and Specific Language Rehabilitations

acronym: CAPP

summary:
Primary progressive aphasias (PPA) represent a challenging group of degenerative language diseases that has led to growing interest in the scientific and medical community. However, a full-blown cognitive/linguistic, anatomic and biologic characterization of the three main variants remains incomplete given that the available data derive from relatively small patient samples. Such a three-fold characterisation will be an major milestone with the prospective of providing the rationale for therapeutic interventions comprising specific rehabilitations protocols and pharmacological trials.

The present study addresses theses issues in the three PPA main variants through a cross-sectional and longitudinal investigation exploring 1) cognitive/linguistic features, 2) anatomic/metabolic specifications (MRI-VBM, MRI-fiber tracking, functional connectivity - MRI resting state, PET), and 3) biologic aspects (CSF biomarkers, genetic screening).

location_facility: Département de Neurologie - Centre des maladies neurologiques, cognitives et comportementales


title: A Pilot, Single-blind, Forced-titration Study to Assess the Hemodynamic and Hormonal Effects, Safety and Tolerability of the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism

summary: The purpose of this study is to determine if LCI699, thorough reductions in aldosterone, can lower BP in patients with Primary hyperaldosteronism.

ReferenceCitation: Schumacher CD, Steele RE, Brunner HR. Aldosterone synthase inhibition for the treatment of hypertension and the derived mechanistic requirements for a new therapeutic strategy. J Hypertens. 2013 Oct;31(10):2085-93. doi: 10.1097/HJH.0b013e328363570c.

oa_colors: green hybrid

evidence: open (via page says license)

unpaywall_oa_status: hybrid

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Amar L, Azizi M, Menard J, Peyrard S, Watson C, Plouin PF. Aldosterone synthase inhibition with LCI699: a proof-of-concept study in patients with primary aldosteronism. Hypertension. 2010 Nov;56(5):831-8. doi: 10.1161/HYPERTENSIONAHA.110.157271. Epub 2010 Sep 13.

lead_sponsor: Novartis


title: Sedation Faisability by Inhalation of Kalinox 170 Bar During Therapeutic Cares in Primary Care Dental Centers

summary: A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of dental cares. This openly clinical trial is done in 36 French primary care dental centers, especially on anxious and phobic patients but also on infants or mental deficient adults. At least 480 patients will be included in this clinical protocol.

lead_sponsor: Air Liquide Santé International


title: Evaluation of an Educational Hand Washing Intervention With a Single-dose Hydroalcoholic Solution on Abscesses in People Who Self-inject Drugs

acronym: HAWA

summary:
The goal of this cluster randomised controlled trial (cRCT) is to to evaluate the effectiveness of an educational intervention combining training in hand-washing with the supply of MONO-RUBs on the reduction of skin abscesses (both observed and self-reported) in people who inject drugs (PWID).

The main questions it aims to answer are:

does an educational intervention change the incidence of injection-related skin and soft tissue infection (SSTI) like abscesses in PWID?
does the educational hand-washing intervention improve injection practices in terms of hand-hygiene in PWID?

According to cluster randomisation, PWID will be assigned to:

Standard harm reduction (HR) services to reduce abscesses plus an educational hand-washing intervention (intervention arm)
Standard HR services only (control arm)

To measure the effectiveness of the educational hand-washing intervention, the primary outcome will be the reduction in abscess prevalence compared in both groups. Statistical analyses for the primary outcome will involve comparing the reduction in abscess prevalence in the intervention arm with that in the control arm. This prevalence will be measured from observed and self-declared data, collected from the injection-site photographs and the face-to-face injection-related SSTI questionnaire, respectively.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Prevention

ReferenceCitation: Hrycko A, Mateu-Gelabert P, Ciervo C, Linn-Walton R, Eckhardt B. Severe bacterial infections in people who inject drugs: the role of injection-related tissue damage. Harm Reduct J. 2022 May 2;19(1):41. doi: 10.1186/s12954-022-00624-6.

ReferenceCitation: Dahlman D, Hakansson A, Kral AH, Wenger L, Ball EL, Novak SP. Behavioral characteristics and injection practices associated with skin and soft tissue infections among people who inject drugs: A community-based observational study. Subst Abus. 2017 Jan-Mar;38(1):105-112. doi: 10.1080/08897077.2016.1263592. Epub 2016 Nov 29.

ReferenceCitation: Sartelli M, Guirao X, Hardcastle TC, Kluger Y, Boermeester MA, Rasa K, Ansaloni L, Coccolini F, Montravers P, Abu-Zidan FM, Bartoletti M, Bassetti M, Ben-Ishay O, Biffl WL, Chiara O, Chiarugi M, Coimbra R, De Rosa FG, De Simone B, Di Saverio S, Giannella M, Gkiokas G, Khokha V, Labricciosa FM, Leppaniemi A, Litvin A, Moore EE, Negoi I, Pagani L, Peghin M, Picetti E, Pintar T, Pupelis G, Rubio-Perez I, Sakakushev B, Segovia-Lohse H, Sganga G, Shelat V, Sugrue M, Tarasconi A, Trana C, Ulrych J, Viale P, Catena F. 2018 WSES/SIS-E consensus conference: recommendations for the management of skin and soft-tissue infections. World J Emerg Surg. 2018 Dec 14;13:58. doi: 10.1186/s13017-018-0219-9. eCollection 2018.

ReferenceCitation: Allegranzi B, Tartari E, Pittet D. "Seconds save lives - clean your hands": the 5 May 2021 World Health Organization SAVE LIVES: Clean Your Hands campaign. J Hosp Infect. 2021 May;111:1-3. doi: 10.1016/j.jhin.2021.03.001. Epub 2021 Mar 7.

ReferenceCitation: Rosenfeld J, Berggren R, Frerichs L. A Review of the Community Health Club Literature Describing Water, Sanitation, and Hygiene Outcomes. Int J Environ Res Public Health. 2021 Feb 15;18(4):1880. doi: 10.3390/ijerph18041880.

ReferenceCitation: Stein MD, Phillips KT, Herman DS, Keosaian J, Stewart C, Anderson BJ, Weinstein Z, Liebschutz J. Skin-cleaning among hospitalized people who inject drugs: a randomized controlled trial. Addiction. 2021 May;116(5):1122-1130. doi: 10.1111/add.15236. Epub 2020 Sep 21.

ReferenceCitation: Phillips KT. Barriers to practicing risk reduction strategies among people who inject drugs. Addict Res Theory. 2016;24(1):62-68. doi: 10.3109/16066359.2015.1068301. Epub 2015 Jul 21.

ReferenceCitation: Degenhardt L, Peacock A, Colledge S, Leung J, Grebely J, Vickerman P, Stone J, Cunningham EB, Trickey A, Dumchev K, Lynskey M, Griffiths P, Mattick RP, Hickman M, Larney S. Global prevalence of injecting drug use and sociodemographic characteristics and prevalence of HIV, HBV, and HCV in people who inject drugs: a multistage systematic review. Lancet Glob Health. 2017 Dec;5(12):e1192-e1207. doi: 10.1016/S2214-109X(17)30375-3. Epub 2017 Oct 23. Erratum In: Lancet Glob Health. 2017 Nov 15;:

ReferenceCitation: Mezaache S, Briand-Madrid L, Rahni L, Poireau J, Branchu F, Moudachirou K, Wendzinski Y, Carrieri P, Roux P. A two-component intervention to improve hand hygiene practices and promote alcohol-based hand rub use among people who inject drugs: a mixed-methods evaluation. BMC Infect Dis. 2021 Feb 25;21(1):211. doi: 10.1186/s12879-021-05895-1.

ReferenceCitation: Roux P, Le Gall JM, Debrus M, Protopopescu C, Ndiaye K, Demoulin B, Lions C, Haas A, Mora M, Spire B, Suzan-Monti M, Carrieri MP. Innovative community-based educational face-to-face intervention to reduce HIV, hepatitis C virus and other blood-borne infectious risks in difficult-to-reach people who inject drugs: results from the ANRS-AERLI intervention study. Addiction. 2016 Jan;111(1):94-106. doi: 10.1111/add.13089. Epub 2015 Sep 28.

ReferenceCitation: Mezaache S, Protopopescu C, Debrus M, Morel S, Mora M, Suzan-Monti M, Rojas Castro D, Carrieri P, Roux P. Changes in supervised drug-injecting practices following a community-based educational intervention: A longitudinal analysis. Drug Alcohol Depend. 2018 Nov 1;192:1-7. doi: 10.1016/j.drugalcdep.2018.07.028. Epub 2018 Sep 5.

ReferenceCitation: Tschudin-Sutter S, Sepulcri D, Dangel M, Ulrich A, Frei R, Widmer AF. Simplifying the World Health Organization Protocol: 3 Steps Versus 6 Steps for Performance of Hand Hygiene in a Cluster-randomized Trial. Clin Infect Dis. 2019 Aug 1;69(4):614-620. doi: 10.1093/cid/ciy948.

ReferenceCitation: Pires D, Soule H, Bellissimo-Rodrigues F, Gayet-Ageron A, Pittet D. Hand Hygiene With Alcohol-Based Hand Rub: How Long Is Long Enough? Infect Control Hosp Epidemiol. 2017 May;38(5):547-552. doi: 10.1017/ice.2017.25. Epub 2017 Mar 7.

ipd_sharing_description: Data obtained through the HaWa study may be provided to qualified researchers with academic interest in harm reduction for PWID. Data or samples shared will be coded, and deidentified. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.

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

collaborators:
AIDES
Nouvelle Aube
IAME INSERM UMR1137


title: Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. (CoV-CONTACT-SERO)

summary:
In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020.

Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital.

Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action.

Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection.

In this study, we aim to evaluate the virological and clinical outcomes of subjects following a contact at high/moderate risk of SARS-CoV-2 acquisition, in community-subjects and/or healthcare workers.

The study population is represented by all subjects who had a contact with laboratory-confirmed SARS-CoV-2 cases and whose contact was considered to be at high/moderate risk of SARS-CoV-2 acquisition.

This include both children and adult subjects, subject without social security, and healthcare workers.

status: Suspended

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

location_country:
French Guiana
France

location_facility: Hôpital Cochin CIC 1417 Bâtiment Lavoisier

location_facility: Centre d'Investigation Clinique Hôpital Saint Louis

location_facility: Centre d'investigation clinique 1432 Hôpital François Mitterrand CHU Bourgogne

location_facility: Service des Maladies infectieuses et tropicales, Pôle Spécialités médicales, CHU Pellegrin

location_facility: Centre d'investigation Clinique 1425, Hôpital Bichat Claude Bernard

location_facility: Centre Investigation Clinique 1415 CHRU Tours - Hôpital Bretonneau

location_facility: Centre d'Investigation Clinique 1403 -CHU Lille

location_facility: Centre d'investigation clinique 1406 CHU Grenoble

location_facility: Service de Maladies infectieuses et tropicales Centre hospitalier

location_facility: Centre Hospitalier Félix Guyon Ile de la Réunion CHU nord

location_facility: Centre d'Investigation Clinique Ile de la Réunion CHU sud

location_facility: Département maladie infectieux CHU Saint Etienne

location_facility: Service de maladies infectieuses et tropicales Hôpital Jean Minjoz CHRU Besançon

location_facility: Centre d'investigation clinique 1414 Service de Pharmacologie clinique CHU Rennes Hôpital Pontchaillou

location_facility: Service des maladies infectieuses Hôpital Gabriel Montpied CHU de Clermont Ferrand

location_facility: Centre Investigation Clinique 1433 CHRU de NANCY


title: Viral Excretion in Contact Subjects at High/Moderate Risk of Coronavirus 2019-nCoV Infection

acronym: Cov-CONTACT

summary:
In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020.

Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital.

Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action.

Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection.

location_facility: Centre Investigation Clinique 1417 Hôpital Cochin Bâtiment Lavoisier


title: E-Compared: Comparative Effectiveness Research on Internet Based Depression Treatment- French Trial

acronym: E-COMPARED

summary: To compare the clinical impact and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU). Within the French context the TAU is considered as the traditional face to face CBT.

ReferenceCitation: van Genugten CR, Schuurmans J, Hoogendoorn AW, Araya R, Andersson G, Banos R, Botella C, Cerga Pashoja A, Cieslak R, Ebert DD, Garcia-Palacios A, Hazo JB, Herrero R, Holtzmann J, Kemmeren L, Kleiboer A, Krieger T, Smoktunowicz E, Titzler I, Topooco N, Urech A, Smit JH, Riper H. Examining the Theoretical Framework of Behavioral Activation for Major Depressive Disorder: Smartphone-Based Ecological Momentary Assessment Study. JMIR Ment Health. 2021 Dec 6;8(12):e32007. doi: 10.2196/32007.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

license: cc-by-sa

license_normalized: cc-by-sa

repository_institution: Universitat Jaume I - Repositori UJI

version: acceptedVersion

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: Technische Universität München - mediaTUM Gesamtbestand

repository_institution: University of Turku - UTUPub

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repository_institution: Linkoping University - DiVA

publisher_dissemination: JMIR Publications

ReferenceCitation: Kleiboer A, Smit J, Bosmans J, Ruwaard J, Andersson G, Topooco N, Berger T, Krieger T, Botella C, Banos R, Chevreul K, Araya R, Cerga-Pashoja A, Cieslak R, Rogala A, Vis C, Draisma S, van Schaik A, Kemmeren L, Ebert D, Berking M, Funk B, Cuijpers P, Riper H. European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries. Trials. 2016 Aug 3;17(1):387. doi: 10.1186/s13063-016-1511-1.

repository_institution: University of Michigan - Deep Blue

repository_institution: Channel View Publications - Multilingual Matters

repository_institution: University of Bern - Bern Open Repository and Information System

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

collaborators:
European Commission
Fondation FondaMental
Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital de la conception Pôle Psychiatrie Centre


title: Effects of Serial Plotting on Fundal Height Charts on Identification and Outcomes of Small for Gestational Age Infants

acronym: HPAG

summary:
Fetal Growth Restriction (FGR) remains a challenging topic for clinicians, researchers and policy makers, and a central question is how to improve the performance of screening during pregnancy in order to provide appropriate care. The recent recommendations and reporting of French results have raised awareness of the need to improve growth screening in France. Based on the existing literature, the hypothesis is that a greater investment in growth monitoring based on a more rigorous interpretation of information available from routinely implemented clinical assessment and ultrasound will allow for significant gains in detection. The current context provides the opportunity to evaluate the application of a training program for serial plotting of Symphysis Fundal Height (SFH) and Estimated Fetal Weight (EFW) on customised charts. This intervention is consistent with French guidelines which support the monthly measurement of SFH, the use of Customised Fetal Weight Reference (CFWR), in particular for referral US (Ultrasound) examinations, and the longitudinal interpretation of growth. These guidelines were recently restated in the clinical practice recommendations issued by the French College of Obstetricians and Gynecologists.

The intervention tested in the trial will include training of professionals for standardization of SFH measurement, introduction of software, and recommendations for growth interpretation and referral examinations. Expected benefits are an increase in antenatal identification of growth restricted fetuses without an increase in the FP rate. Such a program will allow identified Small for Gestational Age (SGA) fetuses to receive appropriate antenatal care. This intervention could double the detection rate of SGA births from 20 to 40%, corresponding to 32 000 infants nationwide annually for whom antenatal care could be improved.

Main objective: To test the effectiveness of the serial plotting of SFH and EFW measures on customised percentile charts supported by provider training, versus standard antenatal care, to improve the detection of FGR. The aim of the investigators is to double rates of antenatal detection from 20 to 40% among SGA infants, defined as a birthweight under the 10th percentile for GA.

ReferenceCitation: Ego A, Prunet C, Lebreton E, Blondel B, Kaminski M, Goffinet F, Zeitlin J. [Customized and non-customized French intrauterine growth curves. I - Methodology]. J Gynecol Obstet Biol Reprod (Paris). 2016 Feb;45(2):155-64. doi: 10.1016/j.jgyn.2015.08.009. Epub 2015 Sep 28. French.

ReferenceCitation: Ego A, Prunet C, Blondel B, Kaminski M, Goffinet F, Zeitlin J. [Customized and non-customized French intrauterine growth curves. II - Comparison with existing curves and benefits of customization]. J Gynecol Obstet Biol Reprod (Paris). 2016 Feb;45(2):165-76. doi: 10.1016/j.jgyn.2015.08.008. Epub 2015 Oct 1. French.

ReferenceCitation: Monier I, Blondel B, Ego A, Kaminiski M, Goffinet F, Zeitlin J. Poor effectiveness of antenatal detection of fetal growth restriction and consequences for obstetric management and neonatal outcomes: a French national study. BJOG. 2015 Mar;122(4):518-27. doi: 10.1111/1471-0528.13148. Epub 2014 Oct 27.

ReferenceCitation: Ego A. [Definitions: small for gestational age and intrauterine growth retardation]. J Gynecol Obstet Biol Reprod (Paris). 2013 Dec;42(8):872-94. doi: 10.1016/j.jgyn.2013.09.012. Epub 2013 Nov 7. French.

ReferenceCitation: Ego A, Subtil D, Grange G, Thiebaugeorges O, Senat MV, Vayssiere C, Zeitlin J. Customized versus population-based birth weight standards for identifying growth restricted infants: a French multicenter study. Am J Obstet Gynecol. 2006 Apr;194(4):1042-9. doi: 10.1016/j.ajog.2005.10.816.

lead_sponsor: University Hospital, Grenoble

location_facility: Department of Obstetrics and Gynecology, Robert Debré Hospital, Assistance Publique-Paris Hospitals (APHP), Paris

location_facility: Department of Obstetrics and Gynecology, North Hospital, Assistance Publique-Marseille Hospitals (APHM), Marseille

location_facility: Department of Obstetrics and Gynecology, Tours University Hospital,

location_facility: Department of Obstetrics and Gynecology, Caen University Hospital, Caen

location_facility: Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux

location_facility: Department of Obstetrics and Gynecology, Antoine Béclère Hospital, Assistance Publique-Paris Hospitals (APHP), Kremlin-Bicêtre

location_facility: Department of Obstetrics and Gynecology, Cochin Hospital, Assistance Publique-Paris Hospitals (APHP), Port Royal

location_facility: Department of Obstetrics and Gynecology, Rouen University Hospital

location_facility: Department of Obstetrics and Gynecology, Paule de Viguier Hospital, Toulouse University Hospital

location_facility: Department of Perinatality, Obstetrics and Neonatology, Civil hospice Lyon

location_facility: Department of Obstetrics and Gynecology, Grenoble University Hospital

location_facility: Department of Obstetrics and Gynecology, Trousseau Hospital, Assistance Publique-Paris Hospitals (APHP)

location_facility: Department of Obstetrics, Gynecology, and Neonatal Care, Hôpital Jeanne de Flandre, University of Lille

location_facility: Department of Obstetrics, Hôpital Poissy-Saint Germain, Versailles-St Quentin University

location_facility: Department of Obstetrics and Gynecology, Hautepierre Hospital, Strasbourg University Hospital, Strasbourg

location_facility: Department of Obstetrics and Gynecology, Louis Mourier Hospital, Assistance Publique-Paris Hospitals (APHP)

appel_a_projets: PHRCN

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU GRENOBLE ALPES

type_etablissement: CH

acronyme: HPAG

titre: Impact sur le dépistage des enfants de petit poids pour l'âge gestationnel, d'une surveillance longitudinale de la croissance foetale par utilisation d'une courbe de hauteur utérine ajustée individuelle au 3ème trimestre

discipline_principale: obstétrique

nom_porteur: EGO

prenom_porteur: Anne


acronym: VIDADO

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

summary: The main objective of this study is to analyze in a population of obese adolescents, the effect of vitamin D3 supplementation in addition to lifestyle and dietary management on vascular function assessed by the change between M0 and M3 of endothelium-dependent vasorelaxation measured at the brachial artery (Flow-Mediated Dilation).

ReferenceCitation: Vinet A, Morrissey C, Perez-Martin A, Goncalves A, Raverdy C, Masson D, Gayrard S, Carrere M, Landrier JF, Amiot MJ. Effect of vitamin D supplementation on microvascular reactivity in obese adolescents: A randomized controlled trial. Nutr Metab Cardiovasc Dis. 2021 Jul 22;31(8):2474-2483. doi: 10.1016/j.numecd.2021.04.025. Epub 2021 May 10.

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

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

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

sponsor_collaborators: UMR1260 NORT Nutrition, Obésité et Risque Thrombotique

sponsor_collaborators: EA4278 PEC Laboratoire de Pharm-Ecologie Cardiovasculaire

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

title: Vascular and Metabolic Effects of Vitamin D Supplementation Associated With Lifestyle Management in Obese Adolescents: Prospective, Randomized, Controlled Trial

type: EudraCT Number

source: euctr


title: Randomized, Double-blinded, Placebo Controlled Study to Assess Efficacy of Oral 35 mg Per Week Risedronate in Preventing Bone Loss in Postmenopausal Women With Aromatase Inhibitor Therapy for Breast Cancer.

acronym: RISAROS

summary:
Aromatase inhibitor therapy is in France the adjuvant reference treatment for postmenopausal women with early-stage breast cancer. This treatment induces bone loss and a higher risk of fractures.

This study aimed to document the effect of bisphosphonate therapy in preventing bone loss and osteoporotic fractures in postmenopausal women with aromatase inhibitor treatment for breast cancer

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Rhumatology et de Pathologie Osseuse, Hôpital Edouard Herriot


title: Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue: Single-center, Controlled, Randomized, Blinded Study

acronym: PAF-tVNS

summary: Chronic fatigue is enhanced by adapted physical activity (APA) programs. Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid benefit from a 4-6 week APA program, with 2 sessions per week. While most patients are improved by these exercise-training programs, for some the benefits remain very modest, and patients describe persistent fatigue. The literature unanimously describes the necessity of longer APA protocols (8-12 weeks, 2-3 sessions/week) for fatigue reduction in fibromyalgia and long Covid. However, it seems difficult to adhere to an optimal program as described in the literature for these fatigued patients. The investigators want to test a device that would both reduce fatigue and improve recovery between APA sessions, in order to gradually reach the recommendations for APA practice. Transcutaneous vagal nerve stimulation (tVNS) seems to be a promising approach. Thus, combining an APA intervention with a tVNS protocol could potentiate the expected and now well-known effect of exercise.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


acronym: DIAVOY

summary:
Traveler's diarrhoea or turista is the most common disease in travelers. It has been reported based on studies in 20 to 60% of travelers, depending among other conditions and travel destinations. Currently, less than 30% of the etiology of diarrhoea is identified by bacteriological v,irological and parasitology traditional techniques. This ignorance of the diarrhoea etiology causes difficulties in the establishment of a specific and rapid management in this extremely common condition and having a significant cost to society. Technological advances in laboratory diagnosis, such as quantitative real-time Polymerase Chain Reaction (PCR), can allow us now to improve the etiological diagnosis of traveler's diarrhoea using simple rectal swabs.

So, the principal objective of this study is to assess the efficacy of a new diagnosis strategy in order to establissh the etiological diagnosis of traveler's diarrhoea. The hypothesis consists in improving the number of patients with a confirmed etiological diagnosis of traveler's diarrhoea by 5%.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Incidence of Iatrogenic Diseases on Toulon-La Seyne Sur Mer Hospital Emergency Consultations During Summer 2018

acronym: EIU

summary:
French population grows older year after year: 24.3% people were over 60 years old in 2006 against 20.6% in 2000 and the expected number might be over 33% in 2050.

The elderly suffer from lots of illnesses, so they usually take lots of drugs. Therefore, this drug use is most likely to have adverse drug reactions.

Finally, according to Health Ministry, the number of emergency department consultations doubled from 1996 to 2016.

Consequently, it is interesting to study the impact of drug iatrogenic effects on emergency consultations.

It would help to prevent these adverse drug reactions as we prescribe those drugs : First, do not harm.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer


title: Acute Dose-response Effect of a Proprietary Botanical Blend Rich in Polyphenols on Flow-mediated Dilation in Healthy Subjects: Randomized, Cross-over, Double-blind Clinical Study

summary:
It is well established that endothelial dysfunction is an early predictor of cardiovascular events in at-risk patients. Finding safe and effective product able to improve endothelial function is of public health interest.

Many clinical studies have shown that monomer of flavanols from cocoa significantly improved endothelial function, in particular endothelium-dependent flow-mediated dilation (ED-FMD) after a single dose. Grape is also a main source of flavanol monomers, that's why many human studies have shown significant effects of grape-derived products on endothelial function within 2 hours following a single dose intake.

The objective of this study is to assess the effect of 2 doses of a proprietary and standardised botanical blend rich in polyphenols (SBRP), on ED-FMD in fasting conditions, in comparison to a placebo, in healthy adults. This blend is made of two botanical extracts: a grape extract and a blueberry extract. In order to provide supportive evidence on the mechanisms and biological plausibility to the clinical effects of the product, appropriate biological parameters and circulating metabolites will be assayed.

lead_sponsor: Activ'inside

collaborators: CIC Inserm 1405, University Hospital Clermont-Ferrand, France

intervention_type: Dietary Supplement


title: Screening for the Hepatitis C Virus by TROD Paired With Mammography and Management of Chronic Hepatitis C in Women Aged 50 to 74 in the Agglomeration of Montpellier

acronym: Mammo'C

summary: In France, a breast cancer screening is organized since 2004 for women aged 50-74. On the other hand, even though the seroprevalence of hepatitis C in the general French population is less than 1%, it is estimated that more than 75,000 people live with the virus without knowing it. To answer the WHO objective of eliminating hepatitis C by 2030 and in France by 2025, the investigators need to organize targeted screening. Women aged more than 50 years old, by their possible antecedents in life, are an exposed population. The investigators propose to pair the already organized breast cancer screening with a hepatitis-screening test by rapid diagnostic orientation test (TROD) and evaluate the adherence of women in this paired screening. For women with positive TROD, a specialized care will be organized.

sponsor_collaborators:
University Hospital, Montpellier
Gilead Sciences

location_facility: Lapeyronie radiology ward (Montpellier University hospital)


title: Optimization of Drug Prescriptions in the Care Pathway for the Elderly, With the Final Objective of Reducing the Iatrogenic Risk.

acronym: IATROPREV

summary: The IATROPREV project is an organizational innovation experimentation project, carried out in Hauts-de-France by the University hospitals of Amiens and Lille, the ARS and the URPS Doctors and Pharmacists of Hauts-de-France and following to the social security financing law of 2018, allowing experimentation with new organizations in the health sector, according to article 51. The objectives of this course are to improve the relevance of prescription in elderly people with multiple drugs as well as, the coordination of care between the city and the hospital through the sharing of information and the establishment of multi-professional consultations between the various care actors.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Health-economic Impact of Pulse Oximetry Systematic Screening of Critical Congenital Heart Disease in Asymptomatic Newborns

acronym: OXYNAT

summary:
Persistant hypoxemia in the newborn confers, even isolated, an abnormal clinical situation, that needs to be addressed for an adequate diagnosis and an optimal treatment.

If during the first hours of life, hypoxemia is frequent and often transient, beyond that, it is necessary to search the various etiological conditions such as a critical congenital heart disease (CCHD) or a non cardiac affection (sepsis, anemia, respiratory disease).

Newborn pulse oximetry screening identifies babies with critical congenital heart disease (CCHD) based on the rational that they frequently have a degree of hypoxemia that may be clinically undetectable. CCHDs are life-threatening forms of congenital heart disease (CHD) occuring in 2-3/1000 live births but accounting for 3%-7.5% of infant deaths.

Early detection is beneficial because of acute collapse, if not resulting in death, is associated with a worse surgical and neurodevelopmental outcome.

Currently, screening for CCHD involves antenatal ultrasound scanning and post-natal physical examination. Although antenatal detection rates have improved over recent years and can be as high as 70%-80% in some centers, this is not consistent. Indeed, in "Nouvelle Aquitaine" overall <50% of CCHDs are detected before birth. In addition, up to a third of infants with CCHD may be missed on post-natal examination. Pulse oximetry screening can help to close the "diagnostic gap' that is, increase the detection of babies who slip through the current screening net.

Several large European studies and a subsequent meta-analysis have shown that pulse oximetry screening is a highly specific (99.9%) and moderately sensitive (76.5%) test which increases CCHD detection rates. The high specificity results in a low false-positive rate 0.05% to 0.5%. But those babies with a Positive Test, if they may not have CCHD, they may be diagnosed with other causes of hypoxemia (congenital pneumonia, sepsis, persistent pulmonary hypertension,...). As with CCHD, delayed recognition of these conditions can result in postnatal collapse and significant morbidity and mortality. It is also more useful to consider these conditions as secondary targets of screening and to remember they constitute 30%-70% of false positives. In 2011, the US Health and Human Services Secretary recommended that pulse oximetry screening for CCHD be added to the Recommended Uniform Screening Panel. In Europe, implementation is advanced in such countries as North European Countries, and Switzerland. There isn't yet any European guidance. In France, the implementation is limited to local and transient experiments. The feasibility, usefulness and cost-effectiveness of routine pulse oximetry screening have not been evaluated so far. The French setting has two specificities : 1/ the antenatal detection rate is considered to be rather high. 2/ in contrast to a lot of other European countries, early discharge from the maternity ward before 48 hours of life is not common, decreasing the risk of discharging a baby with undiagnosed CCHD, but not saving babies from collapse.

- The Investigators hypothesis is that routine pulse oximetry screening in asymptomatic newborns would allow to reduce the incidence of complications related to CCHDs as well as those related to non cardiac pathologies for a reasonable cost for the French Health Care System.

lead_sponsor: University Hospital, Bordeaux

location_facility: Maternité Pernelle d'Aufrédy CH de La Rochelle - Ré - Aunis

location_facility: Maison de Santé Protestante de Bordeaux Bagatelle

appel_a_projets: PRME

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

acronyme: OXYNAT

titre: Etude comparative de l'impact médico-économique du dépistage systématique des pathologies cardiaques critiques par l'oxymétrie de pouls chez le nouveau-né asymptomatique.

discipline_principale: néonatalogie

nom_porteur: Thomas

prenom_porteur: Julie


title: Echocardiographic Standards and Sub-Saharian Africans (SSA) Migrants' in New Aquitaine Region: NEMANA

acronym: NEMANA

summary: Standards Echocardiographic have been defined mainly on caucasian or Asian populations. In the EchoNoRMAL study the criteria for African populations were based solely on data from 198 subjects. This study suggests the presence of different standards depending on the ethnic origin of the subjects. The aims of this study is to describe the proportion of subjects reclassified (normal-pathological) according to the use of echocardiographic norm differences showed in TAHES population (Sub Saharian Africans) with those routinely used

lead_sponsor: University Hospital, Limoges

sponsor_collaborators:
University Hospital, Limoges
University Hospital, Bordeaux

location_facility: Explorations fonctionnelles vasculaires et angiologie (Hôpital Dupuytren)


title: Cytomegalovirus in Perilymphatic Fluid During Cochlear Implantation of Children Presenting a Sensorineural Hearing Loss

acronym: CMVP

summary: In France, children cochlear implantation (CI) is performed 400 times per year. Causes of profound sensorineural hearing loss (SNHL) are represented by congenital malformation of the inner ear for 50 to 60%. Most of the remaining cases of CI in children are caused by congenital CMV infection. The proportion of CMV inducing SNHL with a CI in children is not clearly defined. During CI, we aim to collect a very small sample of perilymphatic fluid and to analyse it with a CMV polymerised-chain-reaction to evaluate the involvement of CMV in SNHL.

ReferenceCitation: Chebib E, Vauloup-Fellous C, Benoit C, Noel Petroff N, Van Den Abbeele T, Maudoux A, Teissier N. Is CMV PCR of inner ear fluid during cochlear implantation a way to diagnose CMV-related hearing loss? Eur J Pediatr. 2023 Jan;182(1):375-383. doi: 10.1007/s00431-022-04691-6. Epub 2022 Nov 12.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Prognostic Positron Emission Tomography/Computed Tomogrpahy Model in Non Small Cell Lung Cancer

summary: Prospective validation of a prognostic model based on advanced PET/CT image analysis in non small cell lung cancer

lead_sponsor: Poitiers University Hospital