title: Prospective Study of Staphylococcus Aureus Clinical Isolates Versus Colonization: RNAs as Potential Biomarkers for Bloodstream Infections

acronym: PROSAC

summary: The primary objective is to demonstrate that the risk of S. aureus bacteremia (SAB) is correlated to the RNA III and SprD RNAs expression

location_facility: Centre Hospitalier Universitaire de Rennes


title: Analgesia Nociception Index (ANI) After Unilateral Radical Mastectomy as an Evaluation of Paravertebral Block Failure

acronym: ANIBPV

summary: Paravertebral Block (PVB) combined with general anesthesia (GA) is a conventional pain treatment for breast surgery but sometimes failures can occurs. The efficacy of this block has to be evaluated. Also, for the intra-operative analgesic evaluation of this block, it is necessary to measure intra-operative analgesia index. A monitor of nociception for patients under GA, the PhysiodolorisTM device, offers an index for measuring nociceptive inputs during surgery in anesthetized patients : the ANI index (based on the single R-R interval analysis). The purpose of this observational and prospective study is to assess the variations of this ANI index during breast surgery with or without axillary node dissection with a PVB. This will allow us to quantify the analgesic effect of a PVB during GA for unilateral radical breast surgery with or without axillary node dissection.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility: Institut de Cancérologie de Lorraine (ICL)

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation

acronym: GENEPSO

summary: Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers

status: Recruiting

enrollment_type: Anticipated

ReferenceType: background

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ReferenceType: result

ReferenceCitation: Andrieu N, Easton DF, Chang-Claude J, Rookus MA, Brohet R, Cardis E, Antoniou AC, Wagner T, Simard J, Evans G, Peock S, Fricker JP, Nogues C, Van't Veer L, Van Leeuwen FE, Goldgar DE. Effect of chest X-rays on the risk of breast cancer among BRCA1/2 mutation carriers in the international BRCA1/2 carrier cohort study: a report from the EMBRACE, GENEPSO, GEO-HEBON, and IBCCS Collaborators' Group. J Clin Oncol. 2006 Jul 20;24(21):3361-6. Epub 2006 Jun 26.

ReferenceCitation: Lecarpentier J, Noguès C, Mouret-Fourme E, Gauthier-Villars M, Lasset C, Fricker JP, Caron O, Stoppa-Lyonnet D, Berthet P, Faivre L, Bonadona V, Buecher B, Coupier I, Gladieff L, Gesta P, Eisinger F, Frénay M, Luporsi E, Lortholary A, Colas C, Dugast C, Longy M, Pujol P, Tinat J; GENEPSO, Lidereau R, Andrieu N. Variation in breast cancer risk associated with factors related to pregnancies according to truncating mutation location, in the French National BRCA1 and BRCA2 mutations carrier cohort (GENEPSO). Breast Cancer Res. 2012 Jul 3;14(4):R99. doi: 10.1186/bcr3218.

family: Lecarpentier

full_name: Julie Lecarpentier

given: Julie

sequence: first

family: Noguès

full_name: Catherine Noguès

given: Catherine

sequence: additional

family: Mouret-Fourme

full_name: Emmanuelle Mouret-Fourme

given: Emmanuelle

family: Gauthier-Villars

full_name: Marion Gauthier-Villars

given: Marion

family: Lasset

full_name: Christine Lasset

given: Christine

family: Fricker

full_name: Jean-Pierre Fricker

given: Jean-Pierre

family: Caron

full_name: Olivier Caron

given: Olivier

family: Stoppa-Lyonnet

full_name: Dominique Stoppa-Lyonnet

given: Dominique

family: Berthet

full_name: Pascaline Berthet

given: Pascaline

family: Faivre

full_name: Laurence Faivre

given: Laurence

family: Bonadona

full_name: Valérie Bonadona

given: Valérie

family: Buecher

full_name: Bruno Buecher

given: Bruno

family: Coupier

full_name: Isabelle Coupier

given: Isabelle

family: Gladieff

full_name: Laurence Gladieff

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

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

ReferenceCitation: GENEPSO : cohorte nationale prospective de personnes porteuses d'une mutation sur les gènes BRCA1 et BRCA2 GENEPSO: French BRCA1/2 carrier cohort study E. Fourme, C. Picard, M.L. Manche-Thévenot, C. Noguès, groupe Génétique et cancer* La Lettre du Sénologue • n° 43 - janvier-février-mars 2009

ReferenceCitation: Bonaïti B, Alarcon F, Bonadona V, Pennec S, Andrieu N, Stoppa-Lyonnet D, Perdry H, Bonaïti-Pellié C; Groupe Génétique et Cancer. [A new scoring system for the diagnosis of BRCA1/2 associated breast-ovarian cancer predisposition]. Bull Cancer. 2011 Jul;98(7):779-95. doi: 10.1684/bdc.2011.1397. French.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Audencia Business School

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Audencia Business School

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

title: Nouveau système de score pour le diagnostic des prédispositions aux cancers du sein et de l’ovaire associées à BRCA1/2

ReferenceCitation: Eisinger F, Bressac B, Castaigne D, Cottu PH, Lansac J, Lefranc JP, Lesur A, Noguès C, Pierret J, Puy-Pernias S, Sobol H, Tardivon A, Tristant H, Villet R. [Identification and management of hereditary predisposition to cancer of the breast and the ovary (update 2004)]. Bull Cancer. 2004 Mar;91(3):219-37. Review. French.

ReferenceCitation: Kuchenbaecker KB, Hopper JL, Barnes DR, Phillips KA, Mooij TM, Roos-Blom MJ, Jervis S, van Leeuwen FE, Milne RL, Andrieu N, Goldgar DE, Terry MB, Rookus MA, Easton DF, Antoniou AC; BRCA1 and BRCA2 Cohort Consortium, McGuffog L, Evans DG, Barrowdale D, Frost D, Adlard J, Ong KR, Izatt L, Tischkowitz M, Eeles R, Davidson R, Hodgson S, Ellis S, Nogues C, Lasset C, Stoppa-Lyonnet D, Fricker JP, Faivre L, Berthet P, Hooning MJ, van der Kolk LE, Kets CM, Adank MA, John EM, Chung WK, Andrulis IL, Southey M, Daly MB, Buys SS, Osorio A, Engel C, Kast K, Schmutzler RK, Caldes T, Jakubowska A, Simard J, Friedlander ML, McLachlan SA, Machackova E, Foretova L, Tan YY, Singer CF, Olah E, Gerdes AM, Arver B, Olsson H. Risks of Breast, Ovarian, and Contralateral Breast Cancer for BRCA1 and BRCA2 Mutation Carriers. JAMA. 2017 Jun 20;317(23):2402-2416. doi: 10.1001/jama.2017.7112.

name: Centre for Cancer Genetic Epidemiology, Department of Public Health and Primary Care, University of Cambridge, Cambridge, England2Wellcome Trust Sanger Institute, Wellcome Trust Genome Campus, Hinxton, Cambridge, England

name: Centre for Epidemiology and Biostatistics, Melbourne School of Population Health, University of Melbourne, Melbourne, Australia

name: Centre for Cancer Genetic Epidemiology, Department of Public Health and Primary Care, University of Cambridge, Cambridge, England

name: Centre for Epidemiology and Biostatistics, Melbourne School of Population Health, University of Melbourne, Melbourne, Australia4Division of Cancer Medicine, Peter MacCallum Cancer Centre, Melbourne, Australia5Department of Medicine, St Vincent’s Hospital, University of Melbourne, Parkville, Australia6Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, Australia

name: Department of Epidemiology, Netherlands Cancer Institute, Amsterdam, the Netherlands

name: Department of Epidemiology, Netherlands Cancer Institute, Amsterdam, the Netherlands8Department of Medical Informatics, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands

name: Centre for Cancer Genetic Epidemiology, Department of Public Health and Primary Care, University of Cambridge, Cambridge, England9Mathematics Institute, University of Warwick, Coventry, England

name: Centre for Epidemiology and Biostatistics, Melbourne School of Population Health, University of Melbourne, Melbourne, Australia10Cancer Epidemiology and Intelligence Division, Cancer Council Victoria, Melbourne, Australia

name: Inserm U900, Paris, France12Institut Curie, Paris, France13Mines ParisTech, Fontainebleau, France14PSL Research University, Paris, France

name: Department of Dermatology, University of Utah School of Medicine, Salt Lake City, Utah

name: Department of Epidemiology, Columbia University, New York, New York

name: Genomic Medicine, Manchester Academic Health Sciences Centre, Institute of Human Development, Manchester University, Central Manchester University Hospitals NHS Foundation Trust, Manchester, England

name: Yorkshire Regional Genetics Service, Chapel Allerton Hospital, Leeds, England

name: West Midlands Regional Genetics Service, Birmingham Women’s Hospital Healthcare NHS Trust, Birmingham, England

name: Clinical Genetics, Guy’s and St Thomas’ NHS Foundation Trust, London, England

name: Department of Medical Genetics and National Institute for Health Research Cambridge Biomedical Research Centre, University of Cambridge, Cambridge, England

name: Oncogenetics Team, Institute of Cancer Research and Royal Marsden NHS Foundation Trust, Sutton, England

name: Department of Clinical Genetics, South Glasgow University Hospitals, Glasgow, Scotland

name: Department of Clinical Genetics, St George’s, University of London, London, England

name: Oncogénétique Clinique, Hôpital René Huguenin/Institut Curie, Saint-Cloud, France

name: Unité de Prévention et d’Epidémiologie Génétique, Centre Léon Bérard, Lyon, France

name: Institut Curie, Department of Tumour Biology, Paris, France28Institut Curie, INSERM U830, Paris, France29Université Paris Descartes, Sorbonne Paris Cité, Paris, France

name: Unité d’Oncogénétique, Centre Paul Strauss, Strasbourg, France

name: Centre de Lutte Contre le Cancer Georges François Leclerc, Dijon, France32Centre de Génétique, Hôpital d’Enfants, CHU Dijon, Dijon, France

name: Department of Medical Oncology, Family Cancer Clinic, Erasmus MC Cancer Institute, Rotterdam, the Netherlands

name: Family Cancer Clinic, Netherlands Cancer Institute, Amsterdam, the Netherlands

name: Department of Human Genetics, Radboud University Medical Center, Nijmegen, the Netherlands

name: Department of Clinical Genetics, VU University Medical Center, Amsterdam, the Netherlands

name: Department of Epidemiology, Cancer Prevention Institute of California, Fremont

name: Departments of Pedicatrics and Medicine, Columbia University, New York, New York

name: Department of Molecular Genetics, University of Toronto, Toronto, Ontario, Canada41Lunenfeld-Tanenbaum Research Institute, Sinai Health System, Toronto, Ontario, Canada

name: Genetic Epidemiology Laboratory, Department of Pathology, University of Melbourne, Parkville, Australia

name: Department of Clinical Genetics, Fox Chase Cancer Center, Philadelphia, Pennsylvania

name: Department of Medicine, Huntsman Cancer Institute, Salt Lake City, Utah

name: Human Genetics Group, Spanish National Cancer Centre, Madrid, Spain46Biomedical Network on Rare Diseases (CIBERER), Madrid, Spain

name: Institute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Leipzig, Germany48LIFE–Leipzig Research Centre for Civilization Diseases, University of Leipzig, Leipzig, Germany

name: Department of Gynaecology and Obstetrics, University Hospital Carl Gustav Carus, Dresden, Germany50National Center for Tumor Diseases, Partner Site Dresden, Dresden, Germany51German Cancer Consortium, Dresden and German Cancer Research Center, Heidelberg, Germany

name: Center for Familial Breast and Ovarian Cancer, Center for Integrated Oncology, Medical Faculty, University of Cologne and University Hospital Cologne, Cologne, Germany

name: Molecular Oncology Laboratory, Hospital Clinico San Carlos, Instituto de Investigación Sanitaria San Carlos, Madrid, Spain

name: Department of Genetics and Pathology, Pomeranian Medical University, Szczecin, Poland

name: Genomics Center, Centre Hospitalier Universitaire de Québec Research Center and Laval University, Québec City, Québec, Canada

name: Prince of Wales Clinical School, University of New South Wales, Sydney, Australia57Department of Medical Oncology, Prince of Wales Hospital, Randwick, Australia

name: Division of Cancer Medicine, Peter MacCallum Cancer Centre, Melbourne, Australia58Department of Medical Oncology, St Vincent’s Hospital, Fitzroy, Australia

name: Department of Cancer Epidemiology and Genetics, Masaryk Memorial Cancer Institute, Brno, Czech Republic

name: Department of Obstetrics and Gynecology and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria61QIMR Berghofer Medical Research Institute, Herston, Australia

name: Department of Obstetrics and Gynecology and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria

name: Department of Molecular Genetics, National Institute of Oncology, Budapest, Hungary

name: Department of Clinical Genetics, Copenhagen University Hospital Rigshospital, Copenhagen, Denmark

name: Department of Oncology and Pathology, Karolinska Institute, Stockholm, Sweden

name: Department of Oncology, Lund University Hospital, Lund, Sweden

name: and the BRCA1 and BRCA2 Cohort Consortium

repository_institution: The University of Manchester - Research Explorer

repositories_institution: The University of Manchester - Research Explorer

title: Risks of Breast, Ovarian, and Contralateral Breast Cancer for BRCA1 and BRCA2 Mutation Carriers

ReferenceCitation: Mancini J, Le Cozannet E, Bouhnik AD, Resseguier N, Lasset C, Mouret-Fourme E, Noguès C, Julian-Reynier C. Disclosure of research results: a randomized study on GENEPSO-PS cohort participants. Health Expect. 2016 Oct;19(5):1023-35. doi: 10.1111/hex.12390. Epub 2015 Jul 23.

name: Aix Marseille Université; UMR_S912; IRD; SESSTIM; Marseille France

name: INSERM; UMR912 (SESSTIM); Marseille France

name: APHM; Hôpital de la Timone; BiosTIC; Marseille France

name: Institut Curie; Hôpital René Huguenin; Saint-Cloud France

name: Institut Paoli-Calmettes; Marseille France

title: Disclosure of research results: a randomized study on GENEPSO-PS cohort participants

ReferenceCitation: Lecarpentier J, Noguès C, Mouret-Fourme E, Buecher B, Gauthier-Villars M, Stoppa-Lyonnet D, Bonadona V, Fricker JP, Berthet P, Caron O, Coupier I, Pujol P, Faivre L, Gesta P, Eisinger F, Mari V, Gladieff L, Lortholary A, Luporsi E, Leroux D, Venat-Bouvet L, Maugard CM, Colas C, Tinat J, Lasset C, Andrieu N; GENEPSO. Breast Cancer Risk Associated with Estrogen Exposure and Truncating Mutation Location in BRCA1/2 Carriers. Cancer Epidemiol Biomarkers Prev. 2015 Apr;24(4):698-707. doi: 10.1158/1055-9965.EPI-14-0884. Epub 2015 Jan 22.

journal_name: Cancer Epidemiology Biomarkers & Prevention

publisher: American Association for Cancer Research (AACR)

publisher_dissemination: American Association for Cancer Research

publisher_group: American Association for Cancer Research

publisher_normalized: American Association for Cancer Research

title: Breast Cancer Risk Associated with Estrogen Exposure and Truncating Mutation Location in BRCA1/2 Carriers

ReferenceCitation: Julian-Reynier C, Resseguier N, Bouhnik AD, Eisinger F, Lasset C, Fourme E, Noguès C. Cigarette smoking in women after BRCA1/2 genetic test disclosure: a 5-year follow-up study of the GENEPSO PS cohort. Genet Med. 2015 Feb;17(2):117-24. doi: 10.1038/gim.2014.82. Epub 2014 Jul 10.

title: Cigarette smoking in women after BRCA1/2 genetic test disclosure: a 5-year follow-up study of the GENEPSO PS cohort

ReferenceCitation: Bureau E, Pellegrini I, Noguès C, Lasset C, Julian-Reynier C. "Maybe they have found something new" participants' views on returning cohort psychosocial survey results. Health Expect. 2015 Dec;18(6):2425-36. doi: 10.1111/hex.12211. Epub 2014 May 30.

name: Aix-Marseille Université; UMR 912; Marseille France

name: Hôpital René Huguenin; Saint Cloud France

name: Institut Paoli-Calmettes; UMR 912; Marseille France

title: “Maybe they have found something new” participants’ views on returning cohort psychosocial survey results

ReferenceCitation: Lapointe J, Dorval M, Noguès C, Fabre R; GENEPSO Cohort, Julian-Reynier C. Is the psychological impact of genetic testing moderated by support and sharing of test results to family and friends? Fam Cancer. 2013 Dec;12(4):601-10. doi: 10.1007/s10689-013-9621-3.

title: Is the psychological impact of genetic testing moderated by support and sharing of test results to family and friends?

ReferenceCitation: Pijpe A, Andrieu N, Easton DF, Kesminiene A, Cardis E, Noguès C, Gauthier-Villars M, Lasset C, Fricker JP, Peock S, Frost D, Evans DG, Eeles RA, Paterson J, Manders P, van Asperen CJ, Ausems MG, Meijers-Heijboer H, Thierry-Chef I, Hauptmann M, Goldgar D, Rookus MA, van Leeuwen FE; GENEPSO; EMBRACE; HEBON. Exposure to diagnostic radiation and risk of breast cancer among carriers of BRCA1/2 mutations: retrospective cohort study (GENE-RAD-RISK). BMJ. 2012 Sep 6;345:e5660. doi: 10.1136/bmj.e5660.

name: on behalf of GENEPSO, EMBRACE, and HEBON

title: Exposure to diagnostic radiation and risk of breast cancer among carriers of BRCA1/2 mutations: retrospective cohort study (GENE-RAD-RISK)

ReferenceCitation: Eisinger F, Fabre R, Lasset C, Stoppa-Lyonnet D, Julian-Reynier C, Nogues C. Spontaneous disclosure of BRCA1/2 genetic test results to employers: a French prospective study. Eur J Hum Genet. 2012 Sep;20(9):981-3. doi: 10.1038/ejhg.2012.37. Epub 2012 Feb 29.

title: Spontaneous disclosure of BRCA1/2 genetic test results to employers: a French prospective study

ReferenceCitation: Pujol P, Lasset C, Berthet P, Dugast C, Delaloge S, Fricker JP, Tennevet I, Chabbert-Buffet N, This P, Baudry K, Lemonnier J, Roca L, Mijonnet S, Gesta P, Chiesa J, Dreyfus H, Vennin P, Delnatte C, Bignon YJ, Lortholary A, Prieur F, Gladieff L, Lesur A, Clough KB, Nogues C, Martin AL; French Federation of Cancer Centres (FNCLCC). Uptake of a randomized breast cancer prevention trial comparing letrozole to placebo in BRCA1/2 mutations carriers: the LIBER trial. Fam Cancer. 2012 Mar;11(1):77-84. doi: 10.1007/s10689-011-9484-4.

name: On behalf the French Federation of Cancer Centres (FNCLCC)

title: Uptake of a randomized breast cancer prevention trial comparing letrozole to placebo in BRCA1/2 mutations carriers: the LIBER trial

ReferenceCitation: Lecarpentier J, Noguès C, Mouret-Fourme E, Stoppa-Lyonnet D, Lasset C, Caron O, Fricker JP, Gladieff L, Faivre L, Sobol H, Gesta P, Frenay M, Luporsi E, Coupier I; GENEPSO, Lidereau R, Andrieu N. Variation in breast cancer risk with mutation position, smoking, alcohol, and chest X-ray history, in the French National BRCA1/2 carrier cohort (GENEPSO). Breast Cancer Res Treat. 2011 Dec;130(3):927-38. doi: 10.1007/s10549-011-1655-3. Epub 2011 Jul 15.

title: Variation in breast cancer risk with mutation position, smoking, alcohol, and chest X-ray history, in the French National BRCA1/2 carrier cohort (GENEPSO)

ReferenceCitation: Dorval M, Noguès C, Berthet P, Chiquette J, Gauthier-Villars M, Lasset C, Picard C, Plante M; INHERIT BRCAs; GENEPSO Cohort, Simard J, Julian-Reynier C. Breast and ovarian cancer screening of non-carriers from BRCA1/2 mutation-positive families: 2-year follow-up of cohorts from France and Quebec. Eur J Hum Genet. 2011 May;19(5):494-9. doi: 10.1038/ejhg.2010.227. Epub 2011 Jan 19.

title: Breast and ovarian cancer screening of non-carriers from BRCA1/2 mutation-positive families: 2-year follow-up of cohorts from France and Quebec

ReferenceCitation: Antoniou AC, Rookus M, Andrieu N, Brohet R, Chang-Claude J, Peock S, Cook M, Evans DG, Eeles R; EMBRACE, Nogues C, Faivre L, Gesta P; GENEPSO, van Leeuwen FE, Ausems MG, Osorio A; GEO-HEBON, Caldes T, Simard J, Lubinski J, Gerdes AM, Olah E, Fürhauser C, Olsson H, Arver B, Radice P, Easton DF, Goldgar DE. Reproductive and hormonal factors, and ovarian cancer risk for BRCA1 and BRCA2 mutation carriers: results from the International BRCA1/2 Carrier Cohort Study. Cancer Epidemiol Biomarkers Prev. 2009 Feb;18(2):601-10. doi: 10.1158/1055-9965.EPI-08-0546. Epub 2009 Feb 3.

title: Reproductive and Hormonal Factors, and Ovarian Cancer Risk for BRCA1 and BRCA2 Mutation Carriers: Results from the International BRCA1/2 Carrier Cohort Study

ReferenceCitation: Brohet RM, Goldgar DE, Easton DF, Antoniou AC, Andrieu N, Chang-Claude J, Peock S, Eeles RA, Cook M, Chu C, Noguès C, Lasset C, Berthet P, Meijers-Heijboer H, Gerdes AM, Olsson H, Caldes T, van Leeuwen FE, Rookus MA. Oral contraceptives and breast cancer risk in the international BRCA1/2 carrier cohort study: a report from EMBRACE, GENEPSO, GEO-HEBON, and the IBCCS Collaborating Group. J Clin Oncol. 2007 Sep 1;25(25):3831-6. Epub 2007 Jul 16.

ReferenceCitation: Chang-Claude J, Andrieu N, Rookus M, Brohet R, Antoniou AC, Peock S, Davidson R, Izatt L, Cole T, Noguès C, Luporsi E, Huiart L, Hoogerbrugge N, Van Leeuwen FE, Osorio A, Eyfjord J, Radice P, Goldgar DE, Easton DF; Epidemiological Study of Familial Breast Cancer (EMBRACE); Gene Etude Prospective Sein Ovaire (GENEPSO); Genen Omgeving studie van de werkgroep Hereditiair Borstkanker Onderzoek Nederland (GEO-HEBON); International BRCA1/2 Carrier Cohort Study (IBCCS) collaborators group. Age at menarche and menopause and breast cancer risk in the International BRCA1/2 Carrier Cohort Study. Cancer Epidemiol Biomarkers Prev. 2007 Apr;16(4):740-6.

ReferenceCitation: Andrieu N, Goldgar DE, Easton DF, Rookus M, Brohet R, Antoniou AC, Peock S, Evans G, Eccles D, Douglas F, Noguès C, Gauthier-Villars M, Chompret A, Van Leeuwen FE, Kluijt I, Benitez J, Arver B, Olah E, Chang-Claude J; EMBRACE; GENEPSO; GEO-HEBON; IBCCS Collaborators Group. Pregnancies, breast-feeding, and breast cancer risk in the International BRCA1/2 Carrier Cohort Study (IBCCS). J Natl Cancer Inst. 2006 Apr 19;98(8):535-44.

ReferenceCitation: Jégu M, Some Der A, Morcel K, Abadie C, Fritel X, Levêque J. [Breast and ovarian cancer due to BRCA1&2 hereditary cancer predisposition syndrome and reproduction: literature review]. J Gynecol Obstet Biol Reprod (Paris). 2015 Jan;44(1):10-7. doi: 10.1016/j.jgyn.2014.10.011. Epub 2014 Nov 18. Review. French.

journal_name: Journal de Gynécologie Obstétrique et Biologie de la Reproduction

title: Cancers du sein et de l’ovaire liés aux mutations constitutionnelles délétères BRCA1&2 et reproduction : revue de la littérature

ReferenceCitation: Feunteun J. [A paradox and three egnimas about the role of BRCA1 in breast and ovarian cancers]. J Soc Biol. 2004;198(2):123-6. Review. French.

ReferenceCitation: Suivi prospectif à 5 ans des tests de prédisposition génétique au cancer du sein et/ou de l'ovaire : comportements de prévention, attentes envers la recherche et inégalités sociales (cohorte nationale Genepso) Institut National du Cancer (INCa) dans le cadre de l'appel à projets 2011 Projets libres de recherché en sciences humaines et sociales, épidémiologie et santé publique.

ReferenceCitation: Bonaïti-Pellié C, Andrieu N, Arveux P, Bonadona V, Buecher B, Delpech M, Jolly D, Julian-Reynier C, Luporsi E, Noguès C, Nowak F, Olschwang S, Orsi F, Pujol P, Saurin JC, Sinilnikova O, Stoppa-Lyonnet D, Thépot F. [Cancer genetics: estimation of the needs of the population in France for the next ten years]. Bull Cancer. 2009 Sep;96(9):875-900. doi: 10.1684/bdc.2009.0943. Review. French.

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

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

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

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

title: Oncogénétique: estimation des besoins de la population en France pour les dix ans à venir


title: Direct Anterior Total Hip Arthroplasty (THA), in Versus Outpatients : A Prospective Monocentric Study in Rennes University Hospital.

acronym: AHVACA

summary: The main objective is to show that cumulative length of stay over the first 45 post operative days (i.e. : primary length of stay and readmission) is significantly lower in the outpatients group than in the inpatients group

status: Unknown status

lead_sponsor: Rennes University Hospital

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


title: Pilot Study for Measuring Molecular Biomarkers and Their Capacity to Characterize Radionuclide Therapy With Lu-177 DOTATATE) in Metastatic G1-G2 Neuroendocrine Midgut Tumors

acronym: GENEBIOLuNET

summary: Midgut neuroendocrine tumours present an increasing incidence and poor survival at 5 years with limited therapeutic options for metastatic, non-operable cases. Lu-177 Dotatate, targeting somatostatin receptors, is an internal vectorized radiotherapy using Lu-177, an ideal radionuclide for peptide radionuclide therapy. In NETTER-1 phase III randomized clinical trial, Lu-177 Dotatate proved its superiority in increasing progression free survival for midgut neuroendocrine tumors. This study hypothesize that finding biomarkers of individual radio sensitivity for this type of internal vectorized therapy would allow treatment personalization. The protocol aim at studying transcript variations induced by this therapy.

study_type: Interventional

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Toulouse

intervention_type: Biological


title: NEURANESTH General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematomas: A Prospective Randomized Trial

summary: This study compare general anesthesia versus locoregional anesthesia for evacuation of chronic subdural hematoma. Half of participant will be operated under general anesthesia, while the other half will be operated under locoregional anesthesia.

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: Undecided

lead_sponsor: University Hospital, Caen

intervention_type: Drug


title: Comprehensive Management of Drug Prescriptions Throughout the Elderly Person's Hospital Care, From Hospital to Home: Impact on Readmission at 30 Days After Delivery

acronym: OPTISORT

summary: This study evaluates the impact of optimizing drug prescriptions on re-admissions of elderly patients within 30 days after hospital discharge. It compares a group of patients receiving comprehensive care (medication reconciliation at hospital entry, multidisciplinary medication review, and medication reconciliation at discharge), versus another group that does not benefit from the program.

status: Completed

study_completion_date_type: Actual

primary_purpose: Prevention

lead_sponsor: Lille Catholic University

status_simplified: Completed


lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronym: AGIR

type: EudraCT Number

source: euctr

title: Treatment With Azacitidine of Recurrent Gliomas With IDH1/2 Mutation

summary:
Glioma are the most commun frequent brain tumour. Mutation of Isocitrate DeHydrogenase IDH1 or IDH2 genes affect 40% of gliomas, mostly grade II and III gliomas. Despite IDH mutated gliomas (IDHm glioma) have a better prognosis compared to the IDH wild type counterparts, they invariably recur after standard treatment with radiotherapy and alkylating agent. IDH mutation results in the accumulation of D-2 hydroxyglutarate (D2HG) produced by the IDH mutant enzyme. D2HG acts as a competitive inhibitor of the alphaketoglutarate cofactor in a wide range of cellular reactions, including Ten-eleven translocation (TET) family enzymes and histone demethylases, resulting in DNA hypermethylation (CIMP phenotype) and histone hypermethylation. Preclinical data have shown a dramatic anti-tumor effect of hypomethylating drugs as 5-azacytidine on IDH1 mutated human gliomas. These hypomethylating drugs are routinely used in myelodysplasic syndrome (MDS) and are well tolerated.

The AGIR Trial will be a phase II, non-comparative, open label, non randomised monocentric trial evaluating efficacy of a treatment by azacitidine in recurrent IDHm gliomas. The main objective is to evaluate the efficacy of azacitidine according to the RANO criteria on progression-free survival at 6 months, evaluated according to the RANO criteria. Given the slow mode of action of treatment, it is proposed to include only patients whose life expectancy at inclusion is greater than 9 months.

A 6-month progression-free survival of less than 15% will be inefficient. The minimum efficiency must be at least 30%. An interim analysis (according to Fleming's method) will be performed when 19 patients have been included and followed up to 6 months. If the interim analysis is inconclusive, 36 additional patients will be included. The maximum number of analysable patients to include is 55.


title: Comparison of the Clinical Effectiveness of the Quadratus Lumborum Block and Femoral Block in the Analgesia of Total Posterior Hip Arthroplasty

acronym: ATHAQLuB

summary:
Patients are painful after total hip arthroplasty. These patients have significant co-morbidities. Analgesics cause significant side effects in this population. Locoregional analgesia is therefore an effective means of reducing the consumption of opioids in this surgery.

The "gold standard" of locoregional analgesia after Total Hip Arthroplasty is the femoral block. However, a new technique has recently been described: the Quadratus Lumborum Block.

The comparison of these two techniques is lacking in the literature. The comparison of the Quadratus Lumborum Block to the femoral block in Total Hip arthroplasty is important in the analgesic strategy of patients undergoing this surgery.

lead_sponsor: CHU de Reims


title: Atrial Function and Supraventricular Arrhythmia of the Veteran Athlete.

summary:
Supraventricular arrhythmias (including atrial fibrillation) are the most common arrhythmias of the veteran athlete and have a major impact in terms of morbidity and mortality. Although moderate sports practice has been shown to decrease the occurrence of these arrhythmias, it has also been shown that very intense athletic activity is associated with an increased risk of developing atrial fibrillation. The pathophysiological mechanism is not clearly understood. However, it has already been shown that intensive sports practice leads to electrical and morphological atrial remodeling, which could be the cause of the occurrence of supraventricular arrhythmias for these athletes.

For sedentary patients, two major tools predict the risk of the onset of supraventricular arrhythmia: the electrocardiogram (ECG) and transthoracic echocardiography (ETT), particularly with the study of atrial function by the analysis of myocardial deformities.

time_perspective: Retrospective

ipd_sharing: No


title: Crystalline Exposition During Pediatric Cranial CT Imaging

acronym: ECTOPIC

summary: This study focuses on reduction of X-rays dose applied to eye's lens during cranial CT in children. Principal objective is to analyse the efficiency of ocular bismuth masks, which are associated with an eye's lens dose modulation

lead_sponsor: University Hospital, Bordeaux


title: Detection of Anti-glomerular Basement Membrane Antibodies (Anti-GBM): a Promising Biomarker for Lupus Nephritis (LN) Screening in Systemic Lupus Erythematosus (SLE) Patients?

acronym: GOODLUPUS

summary:
Introduction and background :

Glomerulonephritis and auto-immune diseases are often associated. Lupus nephritis (LN) is one of the major clinical manifestations of systemic lupus erythematosus (SLE) which have a severe impact on prognosis. This complication is a real challenge for clinicians because of insidious-onset and no predictable relapses. Biomarker use is therefore essential, but conventional biomarkers such as proteinuria have poor sensivity and low specificity to predict LN occurrence, and new more reliable biomarkers (genetic, epigenetic or protein biomarkers) are difficult to use for daily medical practice.

Anti-glomerular membrane basement disease (anti-GBM disease) is a rare (0.5 to 1/millions of inhabitants) and severe illness, characterised by rapidly progressive glomerulonephritis, pulmonary haemorrhage and the presence of anti-GBM antibodies, which are highly sensible (100%) and specific (92-100%) of this condition

. Our experience and literature review

In our department of internal medicine, we report one case of anti-GBM glomerulonephritis associated to an active SLE. After literature review, we note the following studies:

some similar association cases had been reported.
In 2006, a Chinese cohort study highlighted important rates of anti-GBM antibodies, in serum samples from patients with SLE (14 positives/157patients (8.9%) using ELISA method). Moreover, every SLE patient with positive circulating anti-GMB antibodies LN and a severer SLE (with significantly more anemias, pulmonary hemorrhage). According to histological data's, they also had more important kidney damages (10/14 had necrotizing crescentic glomerulonephritis lesions and 5/14 fulfil criteria's for anti-GBM disease diagnosis).

We also note that some authors published experimental studies showing that immunological and genetic links exist between LN and anti-GBM disease, which could explain this association.

3. Main Hypothesis: Based on these findings, we suspect that detection of significant levels of circulating anti-GBM antibodies may be more frequent in SLE followed patients than in general population, and that it could be an interesting biomarker of LN in patient with SLE.

4. Objectives First objective: based on 2 SLE patient groups (one having lupus nephritis and the other without it) we would like to compare the ratio of positive anti-GBM antibodies in each group, expecting a higher rate in SLE patients with LN.

Second objective: will be to study the positive anti-GBM group patients in their clinical aspects, serological features and renal characteristics, in this SLE population.

5. Materials and methods We suggest a retrospective analytic transversal controlled study, based on serum samples from the Lupus Biobank of Upper Rhine (LBBR project), and based on serum samples from healthy voluntary blood donors (control group). We will then perform tests in each serum sample group in our immunology laboratory and compare the ratio of positive anti-GBM in each arm.

design_allocation: Non-Randomized

primary_purpose: Screening


title: The Opinion of Patients With Cancer on the Claeys-Leonetti Law, on Euthanasia and the Search for Determining Factors

acronym: EPAL

summary:
The law of February 2nd 2016, known as Claeys-Leonetti, reformed the legislation of the end of life. It establishes in particular a right of the patient to deep and continuous sedation, makes advance directives binding but refuses access to euthanasia. It states that artificial hydration and nutrition are treatments and not cares, which means that they can be stopped once they are deemed unnecessary, disproportionate or have no other effect than artificial maintenance of life.

While a number of personalities from all walks of life were heard during the parliamentary debate, it was found that patients were not asked about main issues under discussion. Therefore, the investigators found it useful to collect their opinions in the context of individual interviews.

A feasibility study was carried out among 40 patients, which demonstrated the feasibility of such project. This study is the subject of an article which is currently submitted to the BMC Palliative Care Journal.

The main objective is to contribute to the elaboration of the legislation on the end of life, to its adaptation to the wishes of the patients. Patients with cancer and palliative care are directly affected by the legislation on end-of-life, and it seems legitimate that these legislative provisions correspond to their expectations. The aims also to help caregivers to act in accordance with their wishes.

study_start_date_type: Anticipated

primary_purpose: Other

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hopitaux de Marseille


title: Pharmacogenetics of Veno-Occlusive Disease (VOD) in Children With Haematological Stem Cell Transplantation (HSCT)

acronym: MVO

summary:
This project aims to identify common pharmacogenetic biomarkers predisposing children with cancer to develop hepatic VOD during their cancer treatment including HSCT. The impact of VOD occurrence and significant biomarkers will also be evaluated on outcome at day 100 and one year after HSCT. It should help to highlight factors that can contribute to the initiation of hepatic VOD.

Understanding mechanisms of this toxicity and to know individual parameters of disease susceptibility becomes an important issue in the care of these children. The ultimate goal of research in this area would be to develop a personalized predictive medicine and, hopefully, prevent the occurrence of VOD from a therapeutic adaptation to each patient according to his pharmacogenetic profile (adapted prophylaxis, dose adjustment, drug combinations ...). A prospective identification of patients at risk of hepatic VOD will increase the safe use of anticancer.


title: Refractory Diffuse Large B-cell Lymphoma After First-line Immuno-CT: Treatment Options and Outcomes

summary: In the rituximab era, one-third of diffuse large B-cell lymphoma (DLBCL) patients experience relapse/refractory disease after first-line anthracycline-based immunochemotherapy (IChemo). Optimal management remains an unmet medical need. The aim of this study was to report the outcomes of a cohort of refractory patients according to their patterns of refractoriness and the type of salvage option. The investigators performed a retrospective analysis, which included 104 DLBCL patients treated at Lyon Sud University Hospital (2002-2017) who presented with refractory disease. The investigators retrospectively evaluated the outcomes of a cohort of 104 refractory patients according to their patterns of refractoriness and the type of salvage option.

lead_sponsor: Hospices Civils de Lyon


title: Efficacy of Chemotherapy or Chemo-anti-PD-1 Combination After Failed Anti-PD-1 Therapy for Relapsed and Refractory Hodgkin Lymphoma: a Series From Lysa Centers.

summary:
Anti-PD-1 therapy provides high response rates in Hodgkin lymphoma (HL) patients who have relapsed or are refractory (R/R) to autologous stem cell transplantation (ASCT) and brentuximab vedotin (BV), but median progression free survival (PFS) is only one year. The efficacy of treatment following anti-PD-1 is not well known.

In this context, the optimal treatment for patients who failed after anti-PD-1 therapy is an issue. To better assess their outcome, the investigators retrospectively analyzed the characteristics and outcome of patients from 14 LYSA (The Lymphoma Study Association) centers who lost response to anti-PD-1 therapy and received additional CT.


title: DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care (DIANA Study)

acronym: DIANA

summary:
Appropriate initial antibiotic therapy is crucial in the treatment of severe infections in patients with intensive care. Adequate spectrum and appropriate doses are the keys to achieving the therapeutic goal. Despite broad consensus on the spectrum and timing of antimicrobial therapy, antibiotic use varies according to various parameters including choice, dose, method of administration, duration of antibiotic therapy and de-escalation. an empirical attitude.

Therapeutic de-escalation is considered essential for the use of antibiotics and is now clearly established by different consensus. However, routine de-escalation has recently been questioned in a randomized, controlled study that did not demonstrate non-inferiority of de-escalation with an increase in the number of days of antibiotic therapy associated with an increased number of days. superinfection.

The components of the de-escalation described in the literature, are based on the reduction of the number of antibiotics, the strict observance of the spectrum of the antibiotic, the reduction of use of the antibiotic, the stopping of any inappropriate antibiotic treatment ( lack of in vitro activity).

De-escalation can be considered in different ways; there are significant variations between hospitals, countries, teams. A large European multicenter cohort is needed.

The main objective of this study is to describe empiric antibiotic therapy in intensive care and the modalities of de-escalation.


title: FALCOn (Facteur AnthropoLogique Cancer Orl) Evaluation Des Facteurs Anthropologiques, Socio-culturels et Psychologiques Des Praticiens Qui Conditionnent la Prise de décision Pour Les Patients Atteints de Cancer Des VADS

acronym: FALCOn

summary:
There are no studies on practitioner-related factors influencing decision-making in the field of carcinology of aerodigestive carcinomas. The objective of the study is to determine what are the anthropo-sociological factors in the surgeon, the oncologists and radiotherapists influencing decision making in ear, nose, and throat carcinology. Special attention will be paid to the practitioner's gender, age, geographical origin, place and institution of training, place of practice, volume of patients treated, access to or without reconstruction by microsurgery, his tendency or aversion to risk taking.

Main objectives : To determine the individual professional and non-professional characteristics influencing physicians' decision-making in oncology of aerodigestive carcinomas between choices:

Surgery
Radio and / or chemotherapy
Support care
Neo-adjuvant chemotherapy and reassessment
Secondary objectives : Identify if certain patient profiles may lead to heterogeneous treatment decisions i.e. Human Papillomavirus status, age, comorbidities, autonomy, etc.

ReferenceCitation: Krähenmann-Müller S, Virgini VS, Blum MR, da Costa BR, Collet TH, Martin Y, Cornuz J, Zimmerli L, Gaspoz JM, Bauer DC, Kerr EA, Aujesky D, Rodondi N. Patient and physician gender concordance in preventive care in university primary care settings. Prev Med. 2014 Oct;67:242-7. doi: 10.1016/j.ypmed.2014.08.004. Epub 2014 Aug 10.

family: Krähenmann-Müller

full_name: Simone Krähenmann-Müller

given: Simone

family: Virgini

full_name: Vanessa S. Virgini

given: Vanessa S.

family: Blum

full_name: Manuel R. Blum

given: Manuel R.

family: da Costa

full_name: Bruno R. da Costa

given: Bruno R.

family: Collet

full_name: Tinh-Hai Collet

given: Tinh-Hai

family: Martin

full_name: Yonas Martin

given: Yonas

family: Cornuz

full_name: Jacques Cornuz

given: Jacques

family: Zimmerli

full_name: Lukas Zimmerli

given: Lukas

family: Gaspoz

full_name: Jean-Michel Gaspoz

given: Jean-Michel

family: Bauer

full_name: Douglas C. Bauer

given: Douglas C.

family: Kerr

full_name: Eve A. Kerr

given: Eve A.

family: Aujesky

full_name: Drahomir Aujesky

given: Drahomir

family: Rodondi

full_name: Nicolas Rodondi

given: Nicolas

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Preventive Medicine

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: Université de Lausanne - SERVAL

version: acceptedVersion

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: submittedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Andersen MR, Urban N. Physician gender and screening: do patient differences account for differences in mammography use? Women Health. 1997;26(1):29-39.

ReferenceCitation: Franks P, Clancy CM. Physician gender bias in clinical decisionmaking: screening for cancer in primary care. Med Care. 1993 Mar;31(3):213-8.

ReferenceCitation: Frank E, Harvey LK. Prevention advice rates of women and men physicians. Arch Fam Med. 1996 Apr;5(4):215-9.

ReferenceCitation: Arrington AK, Jarosek SL, Virnig BA, Habermann EB, Tuttle TM. Patient and surgeon characteristics associated with increased use of contralateral prophylactic mastectomy in patients with breast cancer. Ann Surg Oncol. 2009 Oct;16(10):2697-704. doi: 10.1245/s10434-009-0641-z. Epub 2009 Aug 4.

family: Arrington

full_name: Amanda K. Arrington

given: Amanda K.

family: Jarosek

full_name: Stephanie L. Jarosek

given: Stephanie L.

family: Virnig

full_name: Beth A. Virnig

given: Beth A.

family: Habermann

full_name: Elizabeth B. Habermann

given: Elizabeth B.

family: Tuttle

full_name: Todd M. Tuttle

title: Patient and Surgeon Characteristics Associated with Increased Use of Contralateral Prophylactic Mastectomy in Patients with Breast Cancer

ReferenceCitation: Tsugawa Y, Jena AB, Figueroa JF, Orav EJ, Blumenthal DM, Jha AK. Comparison of Hospital Mortality and Readmission Rates for Medicare Patients Treated by Male vs Female Physicians. JAMA Intern Med. 2017 Feb 1;177(2):206-213. doi: 10.1001/jamainternmed.2016.7875.

name: Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts4Department of Medicine, Massachusetts General Hospital, Boston5National Bureau of Economic Research, Cambridge, Massachusetts

name: Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts6Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts

name: Division of Cardiology, Massachusetts General Hospital, Boston

name: Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, Massachusetts2Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts8Veterans Affairs Healthcare System, Boston, Massachusetts

ReferenceCitation: Mehrotra A, Reid RO, Adams JL, Friedberg MW, McGlynn EA, Hussey PS. Physicians with the least experience have higher cost profiles than do physicians with the most experience. Health Aff (Millwood). 2012 Nov;31(11):2453-63. doi: 10.1377/hlthaff.2011.0252.

name: Ateev Mehrotra (         ) is an associate professor of medicine, Division of General Internal Medicine, University of Pittsburgh School of Medicine, and a policy analyst at the RAND Corporation in Pittsburgh, Pennsylvania.

name: Rachel O. Reid is a medical student at the University of Pittsburgh.

name: John L. Adams is principal senior statistician at the Kaiser Permanente Center for Effectiveness and Safety Research, in Pasadena, California.

name: Mark W. Friedberg is a natural scientist at the RAND Corporation, a practicing general internist, and a clinical instructor at Brigham and Women’s Hospital and Harvard Medical School, in Boston, Massachusetts.

name: Elizabeth A. McGlynn is director of the Kaiser Permanente Center for Effectiveness and Safety Research, in Pasadena, California.

name: Peter S. Hussey is a policy researcher at the RAND Corporation in Arlington, Virginia.

title: Physicians With The Least Experience Have Higher Cost Profiles Than Do Physicians With The Most Experience

ReferenceCitation: Meier P, Duvernoy CS. Influence of gender of physicians and patients on guideline-recommended treatment of chronic heart failure in a cross-sectional study. Eur J Heart Fail. 2009 Jun;11(6):631; author reply 631-2. doi: 10.1093/eurjhf/hfp056. Epub 2009 Apr 27.

name: Department of Cardiology; University Hospital of the Saarland; Kirrbergerstr 66421 Homburg/Saar Germany

name: AWD.pharma GmbH & Co. KG; Wasastraße 50 01445 Radebeul Germany

title: Influence of gender of physicians and patients on guideline-recommended treatment of chronic heart failure in a cross-sectional study: reply

ReferenceCitation: Berthold HK, Gouni-Berthold I, Bestehorn KP, Böhm M, Krone W. Physician gender is associated with the quality of type 2 diabetes care. J Intern Med. 2008 Oct;264(4):340-50. doi: 10.1111/j.1365-2796.2008.01967.x. Epub 2008 Apr 4.

ReferenceCitation: Reid RO, Friedberg MW, Adams JL, McGlynn EA, Mehrotra A. Associations between physician characteristics and quality of care. Arch Intern Med. 2010 Sep 13;170(16):1442-9. doi: 10.1001/archinternmed.2010.307.

title: Associations Between Physician Characteristics and Quality of Care

ReferenceCitation: Schieber AC, Delpierre C, Lepage B, Afrite A, Pascal J, Cases C, Lombrail P, Lang T, Kelly-Irving M; INTERMEDE group. Do gender differences affect the doctor-patient interaction during consultations in general practice? Results from the INTERMEDE study. Fam Pract. 2014 Dec;31(6):706-13. doi: 10.1093/fampra/cmu057. Epub 2014 Sep 11.

ReferenceCitation: Allais, M. (1953). L'extension des théories de l'équilibre économique général et du rendement social au cas du risque. Econometrica, Journal of the Econometric Society, 269-290.


title: Clinical Characteristics and Outcomes of Relapsed Follicular Lymphoma After Autologous Stem Cell Transplantation at Rituximab Era

summary:
Introduction High dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT) is a therapeutic option in follicular Lymphoma after first line treatment failure. The clinical characteristics and outcome of FL patients who relapsed after HDT+ASCT and therapeutic management in the rituximab era are not well known and may represent a difficult challenge.

Patients and Methods: The investigators conducted a retrospective analysis of FL patients who relapsed after HDT+ASCT in four French centers treated between 2000 and 2014. Clinical records were reviewed for clinical characteristics and treatment strategy at relapse. The investigators aimed to identify prognostic factors related to patient's outcome.

location_facility: Centre Hospitalier Lyon Sud, Hematology department


title: Strain Echocardiography During Septic Shock : an Observational Pilot Study

acronym: Sepsistrain

summary:
The mortality of septic shock remains high nowadays despite a trend toward improvement.Septic cardiomyopathy has been reported in most experimental models of sepsis shock. Its relationship with mortality is unclear. A decrease in mortality have been reported in patients with decreased left ventricular ejection fraction (LVEF), but a recent meta-analysis did not support such results. In fact, it appears that high LVEF are linked to profound vasoplegia which is associated to bad outcome.

In the other hand, alterations of Strain echocardiography, a new method allowing a more sensitive evaluation of heart function, have been associated with a worse outcome in sepsis patients. Only few studies have examined echocardiographic strain during sepsis shock in human, and its natural history was only described in pigs. Moreover, the right ventricular strain was reported only by Orde et al whereas the evolution of strain during fluid infusion have never been studied. The aim of the present study is to describe the natural history of echocardiographic strain during sepsis shock and to determine its prognosis value.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

intervention_type: Device


title: Parents' Experience of Their Children Stay in a Pediatric Intensive Care Unit.

acronym: VECUREA

summary:
Children recovered in pediatric intensive care unit (PICU) suffer from severe conditions, sometimes life-threatening. Thus, priority is given to urgent somatic care, children medicalization is strong, invasive technics have to be used, and medical monitoring is close.

A stay in PICU often leaves a painful memory to the child and family, and can lead to psychological morbidity such as post-traumatic stress disease.

This study aims to assess parents' experience during their child hospitalization in PICU, and the impact of this stay on the entire family in the following month.

location_facility: Pediatric intensive care unit of Women-Mother-Children Hospital


title: Correlation Between Clinical Signs and High-resolution Manometry Data in Children

summary:
High resolution oesophageal manometry (HRM) is the gold standard for the diagnosis of oesophageal motility disorder.

Standard esophageal manometry has been replaced since 2000 by high resolution manometry. This one allows a more precise study with a spatio-temporal representation of the esophageal pressure values as well as an easier realization with in particular a better tolerance of the examination which is important in pediatrics.

Over a period of 10 years only a dozen studies were conducted in children. No study to date has evaluated the global place of MHR in current practice in children across all indications.

The indications that lead to the realization of a manometry in children are given by some experts but there is currently no clinical study to define the sensitivities, specificity and predictive values of clinical symptoms leading to the completion of this examination and endoscopic signs found upstream.

In addition, the link between certain underlying conditions and the manometric result has never been evaluated.

II / Objective: The objective of our study is to calculate the sensitivity, the specificity and the predictive values of each clinical and endoscopic sign according to the manometric result found and this by age group. The goal is to better define the predictive signs of the selected manometric diagnoses and therefore the indications to remember in the child.

III / Methodology:

Bi-centric retrospective collection of data on patient records in Marseille and Lille. Collection dates: from 2012 (beginning of high resolution manometry in Marseille and Lille) to December 2016.

The clinical and endoscopic signs selected will be decided a priori by an expert committee consisting of 2 adult gastroenterologists specializing in manometry, 1 pediatrician specialist in manometry, and 3 gastro-pediatricians.

Inclusion Criteria: All minor patients (<18 years old) referred for 1 st high-resolution manometry (or 2 nd or more examination if performed in the presence of a new symptom).

Number of subjects planned: all the patients who had a manometry (about 300 patients) over the given period


title: Assessment of Professional Practices - Arterial Doppler Waveforms Analysis in PAD

acronym: APP-Wave-PAD

summary:
The main objective is to evaluate the differences of terminology used when describing arterial doppler waveforms.

To assess the impact of an educational process

status: Enrolling by invitation

time_perspective: Cross-Sectional


title: Incidence and Severity of Acute Respiratory Distress Syndrome (ARDS) in the French Wounded Soldiers

acronym: SDRA-OPEX

summary: The purpose of this study is to evaluate the incidence of the ARDS in the French wounded soldiers.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Sainte Anne


title: Comprehensive Assessment of Motor Imagery Ability After Stroke

acronym: AVCIM

summary: Individuals with stroke may experience sensory-motor deficit and/or neglect, with possible reduction in motor imagery ability (MI). To our knowledge, no study completely investigated MI ability in one individual whereas MI practice can be performed using visual or kinesthetic modalities (respectively visualizing with mind's eyes or imagining movement using sensation) and internal or external perspectives (performing action as spectator or as actor). This study aims to investigate MI ability in patients with stroke as compared to aged-matched healthy individuals. The investigators will assess explicit MI ability using 3 questionnaires (Movement Imagery Questionnaire-RS - MIQ-RS, Kinesthetic and Visual Imagery Questionnaire-20 - KVIQ-20, Vividness of Movement Imagery Questionnaire-2 - VMIQ-2) and 2 tests (imagined Time Up and Go - iTUG, imagined Box and Block test - iBBT). Outcome parameters will be i) the composite score of vividness measured for all tests using Likert scales, ii) the temporal equivalence between MI and Physical practice (PP - where MI/PP ratio equal to 1 indicate good MI ability and respect of temporal equivalence between MI and PP) and iii) the amplitude of electrodermal activity. The investigators will also study implicit MI ability using a hand laterality judgment task. Outcomes parameters will be response time (i.e. the duration to identify the hand laterality) and the percentage of correct responses.

primary_purpose: Basic Science

intervention_type: Behavioral


title: Better Understanding Slow Language Impairment: Cognitive and Genetic Mechanisms

summary: This study was designed to examine the development of children aged 6 to 10 with slow language impairment (SLI). The aim was threefold: (1) to investigate language skills of children with SLI at different levels - formal, semantic, pragmatic- in comparison with those of control children; (2) to test a procedural deficit hypothesis: abnormal development in the procedural memory system could account for some language deficits; (3) to make genotype-phenotype comparisons, focusing on the different levels of language development and on procedural skills. The main hypothesis is that genetic mutations, contingently epistatique, will lead to procedural learning deficit, which will have a negative impact on language skills at the formal level and consequently on semantic and pragmatic levels.


status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

acronym: BIGGER

title: Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects Commencing Antiretroviral Therapy: the BIGgeR Study.

summary: Co-morbidities, including low bone mineral density, increased visceral adiposity and chronic kidney disease (CKD) are frequent in people living with HIV, and may be driven by ongoing inflammation and immune activation. Initiation of ART reduces inflammation and immune activation and is associated with changes in bone and renal biomarkers and gut microbiota. Investigators hypothesise that changes in gut microbiome when starting antiretroviral therapy correlate to changes in bone and renal biomarkers and wish to explore possible mechanisms linking these by investigating changes in markers of inflammation and immune activation.


title: Interventional Trial in Primary Care of Medico-social Mediation on the Prevention of the Return to Emergencies Among People in a Precarious Social Situation

summary:
This research aims to evaluate a new mode of care for precarious public through a medico-social mediation device after emergencies, with the aim of improving their care and to prevent possible complications.

The main objective is to evaluate the effectiveness of management by a medico-social mediation device set up within 48 hours after leaving emergency on the 90-day emergency readmission rate. people living in precarious situations.

prospective randomized interventional trial with two arms. Patients will complete questionnaires assessing precariousness, quality of life, health literacy, and time perspective. Eligible patients (726 subjects) are randomized : control group (usual management) or experimental group (patient is contacted within 48 hours by a medico-social mediator familiar with the territory), and followed for 90 days by the latter, in order to optimize and secure the care path.

Readmissions are identified from emergency database and Regional Emergency Terminal and documented.

Patients in the experimental group benefit from the support of a local health mediator who carries out a diagnosis of the person's needs in order to follow his or her care path in an optimal way. It implements and ensures with the patient and his entourage the follow-up of the care through his network of professionals of the social sector and the health.

The study will be under the responsibility of a multidisciplinary scientific committee experienced in public health, epidemiology and social psychology of health, in the field of emergencies, precariousness and medico-social mediation, and excellent knowledge. territories concerned.


title: Effects of Butyrate Enemas on Postoperative Intestinal Mobility Disorders in Hirschsprung's

acronym: Buty-Hirsch

summary:
Hirschsprung's disease (HD) is a rare disease defined as a congenital absence of enteric ganglia, resulting usually in neonatal bowel obstruction. The current treatment is the operative removal of the aganglionic bowel and anastomosis to the ganglionic zone considered as 'healthy'. However, postoperative course remains unpredictable.

Functional intestinal disorders are present in up to 45% of patients and can occur in the immediate postoperative period or few weeks/years later.

Until now, there are neither predictive factors of postoperative digestive complications nor established treatment for postoperative dysmotility in HD. Abnormalities in enteric nervous system (ENS) phenotype and functions in the 'healthy' ganglionic segment are increasingly suspected to be directly responsible for postoperative intestinal dysfunctions in HD. Therefore, approaches aimed at restoring the nitrergic phenotype could be of major therapeutical interest. Among targets regulating the nitrergic phenotype of ENS are the microbiota and/or derived metabolites. Indeed preclinical animal models deficient in bacterial sensing molecules have a loss of nitrergic neurons and reduced colonic transit. Conversely, microbiota transfer to newborn germ-free mice restored colonic transit time. Alternatively the investigators has shown that bacterial metabolites such as short-chain fatty acids, in particular butyrate, can increase nitrergic phenotype and enhance colonic motility in a gut immaturity animal model. Therefore the investigators hypothesize preoperative butyrate enema will reduce postoperative intestinal complications at short-term and medium/long-term.


title: Evaluation of Long-term Health-related Quality of Life After Massive Burn Injury : A Twenty Years' Experience in a Burn Center

acronym: HR - QOL MR

summary: Massive burns are serious life-threatening conditions. Recent advances in their management now allow the survival of a growing number of patients. The burn care paradigm is transformed: the evaluation of survival at the end of acute care is no longer sufficient for a good evaluation of practices; the attention now focuses on long-term health-related quality of life (HR-QOL).The recently validated French translation of the burn specific health scale brief version makes this evaluation now feasible in French burn centers. The objectives of this study are to evaluate the HR-QOL of massive burn survivors, to compare it to another chronic condition (necrotizing fasciitis) and to determine the main predictive factor of health-related quality of life. This study is retrospectively conducted in 18 patients who survived a massive burn injury involving more than 80% of the total body surface area, or more than 70% of the total body surface area if the injury occured during childhood and who were treated between 1997 and 2017 in our Lyon burn center. Short Form-36 Medical Outcomes Survey (SF-36), and Brief Version of Burn Speciﬁc Health Scale (BSHS-B) are used for the present evaluation.

location_facility: Hospices Civils de Lyon, Croix-Rousse Hospital


title: Grey Matter Damage at the Earliest Phase of Multiple Sclerosis : a Longitudinal 7T Magnetic Resonance Imaging Study

summary: The present study is an opportunity to assess grey matter damage at the earliest phase of Multiple Sclerosis (MS) allowing to a better understanding of its origins and its impact and disease severity. This study is a preliminary longitudinal study to precisely depict the kinetic of grey matter damage and the links with disease aggravation. Thirty MS patients without time and spatial dissemination criteria (only one symptomatic MRI lesion detected) but with oligoclonal bands detected on cerebro spinal fluid analysis will be included for a monocentric transversal MRI study at 7T to assess grey matter injury. Clinical and neuropsychological assessments will be performed in the population the same day of a multi-parametric MRI. A longitudinal clinical and MRI follow up will be performed during 2 years.


type: Other Identifier

title: A Monocentric, Comparative and Randomized Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery

acronym: MEPICARD

summary:
The study is a randomised controlled trial of patients admitted for a scheduled cardiac surgery at the Clermont-Ferrand hospital.

Patients meeting the study inclusion criteria will be allocated to either the control group that will receive pressure ulcer prevention standard care or the intervention group that will receive pressure ulcer prevention standard care plus have a Mepilex® Border dressing applied to their sacrum.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Combination Product


title: Body Composition and Bone Mineral Density in Patients With Psoriatic Arthritis and Changes After 6 Months of Treatment With Ustekinumab

acronym: STELARA-CC

summary:
There is not much body composition and bone mineral density data available for patients with psoriatic arthritis (rheumatoid arthritis) compared to control subjects.

The evaluation of the total fat mass and in particular of its abdominal distribution (visceral adiposity) is important because an excessive adiposity generates adverse effects on the health (hypertension, dyslipidemia, cardiovascular risk and resistance to the insulin).

In addition, data on changes in body composition and bone mineral density were not available under a new psA treatment, namely ustekinumab (anti-IL12 / 23 antibody).

It is proposed to conduct a pilot study to evaluate body composition, distribution (visceral adiposity) and bone mineral density in patients with psoriatic arthritis (versus control subjects) and their changes after 6 months of treatment with ustekinumab

lead_sponsor: University Hospital, Lille


title: Dose Study of Tranexamic Acid in Total Hip Replacement to Reduce Post-operative Hemoglobin Loss: A Phase 2 Randomized Double-blind Monocentric Study

acronym: PRADO

summary: A single preoperative dose of tranexamic acid (TXA) reduces blood loss and red blood cell transfusion in primary hip arthroplasty. Numerous regimens have been tested, ranging from 10mg/kg up to 3g. However the optimal dose to administer is unknown.


title: Effects of Combined Treatment by Botulinum Toxin A and Robot-Assisted Gait Training (Lokomat®) on Walking Ability in Patients With Chronic Stroke: a Prospective, Controlled, Randomized Study

acronym: Lokomat

summary:
75% patients in the chronic phase of a stroke keep walking disabilities. Focal spasticity in the paretic lower limb frequently causes these walking disabilities, and the gold standard treatment is intramuscular injection of Botulinum toxin A in the spastic muscles.

To potentiate the effects of toxin, walking rehabilitation is usually prescribed in the weeks following injection, but the protocols vary and few have been evaluated in the medical literature.

In particular, the effect on walking ability of combined treatment by botulinum toxin A and robot-assisted gait training has never been evaluated.

Tested hypothesis: Robot-assisted gait training by Lokomat® motorized exoskeleton potentiates botulinum toxin's effects better than conventional walking therapy.

The aim of this study was to evaluate the effects on walking ability of the association of focal spasticity treatment by Botulinum toxin and Lokomat-assisted walking rehabilitation in patients suffering from spastic hemiparesia after stroke in the chronic phase.

Outcome:

-Primary: distance walked (meters) in the six-minute walk test (SMWT)

Prospective, randomized, controlled, opened, monocentric study with a crossover design.

Recruitment of patients over 18 years of age, in the chronic phase of stroke, who have already been treated by Botulinum toxin injection for focal spasticity in our PMR ward.

Assessment at Day one (D0), Week four (W4) and Week eight (W8).

Following a preliminary study which had the six-minute walk test as a secondary outcome, the expected results are a significant improvement of the distance walked in the SMWT after robotic rehabilitation, and a lack of significant improvement following conventional therapy.

The study should serve to further harmonize and optimize rehabilitation protocols after toxin injections, and to justify the use of robotic rehabilitation for patients in the chronic phase of stroke.


title: Impact of the Introduction of ORKAMBI on Anxiety, Depression, Quality of Life and Adherence of Adolescents and Young Adults

acronym: ORK-AJA

summary: The aim of this project is to evaluate the psychological reshuffle induced by ORKAMBI. The particular focus of this study is the consequence of its introduction on anxiety, depression, quality of life and adherence to all cystic fibrosis (CF) treatment. To answer this question investigators will monitor the psychological function of CF adolescents and young adults treated with ORKAMBI and compare them to CF adolescents and young adults not treated with ORKAMBI.

ReferenceCitation: Pendleton DA, David TJ. The compliance conundrum in cystic fibrosis. J R Soc Med. 2000;93 Suppl 38:9-13. Review.

ReferenceCitation: Bucks RS, Hawkins K, Skinner TC, Horn S, Seddon P, Horne R. Adherence to treatment in adolescents with cystic fibrosis: the role of illness perceptions and treatment beliefs. J Pediatr Psychol. 2009 Sep;34(8):893-902. doi: 10.1093/jpepsy/jsn135. Epub 2009 Feb 5.

ReferenceCitation: Zindani GN, Streetman DD, Streetman DS, Nasr SZ. Adherence to treatment in children and adolescent patients with cystic fibrosis. J Adolesc Health. 2006 Jan;38(1):13-7.

ReferenceCitation: Butner J, Berg CA, Osborn P, Butler JM, Godri C, Fortenberry KT, Barach I, Le H, Wiebe DJ. Parent-adolescent discrepancies in adolescents' competence and the balance of adolescent autonomy and adolescent and parent well-being in the context of Type 1 diabetes. Dev Psychol. 2009 May;45(3):835-49. doi: 10.1037/a0015363.

ReferenceCitation: Arias Llorente RP, Bousoño García C, Díaz Martín JJ. Treatment compliance in children and adults with cystic fibrosis. J Cyst Fibros. 2008 Sep;7(5):359-67. doi: 10.1016/j.jcf.2008.01.003. Epub 2008 Mar 4.

family: Arias Llorente

full_name: Rosa Patricia Arias Llorente

given: Rosa Patricia

family: Bousoño García

full_name: Carlos Bousoño García

given: Carlos

family: Díaz Martín

full_name: Juan José Díaz Martín

given: Juan José

journal_name: Journal of Cystic Fibrosis

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

title: Treatment compliance in children and adults with Cystic Fibrosis

ReferenceCitation: Marciel KK, Saiman L, Quittell LM, Dawkins K, Quittner AL. Cell phone intervention to improve adherence: cystic fibrosis care team, patient, and parent perspectives. Pediatr Pulmonol. 2010 Feb;45(2):157-64. doi: 10.1002/ppul.21164.

ReferenceCitation: Blackwell LS, Marciel KK, Quittner AL. Utilization of patient-reported outcomes as a step towards collaborative medicine. Paediatr Respir Rev. 2013 Sep;14(3):146-51. doi: 10.1016/j.prrv.2013.04.003. Epub 2013 May 27.

ReferenceCitation: Girerd X, Radauceanu A, Achard JM, Fourcade J, Tournier B, Brillet G, Silhol F, Hanon O. [Evaluation of patient compliance among hypertensive patients treated by specialists]. Arch Mal Coeur Vaiss. 2001 Aug;94(8):839-42. French.

ReferenceCitation: Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7.

ReferenceCitation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13.

location_facility: Department of Pneumology -CRCM - Necker - Enfants maladies Hospital (AP-HP)


title: Multicenter Prospective Observational Study of the Outcome of Patients With Acute Myeloblastic Leukemia (AML) and Myelodysplastic Syndrome (MDS) Receiving Iron Chelation Therapy (Exjade) After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)

acronym: GREFFE

summary:
Iron chelation, mostly associated with multiple red blood cell transfusion, is relatively common in patients with hematological malignancies receiving allo-HSCT.

This multicenter prospective observational study is designed to establish the impact of iron chelation on relapse after allo-HSCT in patients with acute myeloid leukemia and myelodysplastic syndrome. The investigators will compare the results obtained in the prospective study to those observed in a historical retrospective cohort of paired patients who did not receive chelation. Given our clinical experience and literature results, the investigators will evaluate the Exjade chelator. Although not demonstrated, the presence of mutations of the HFE gene could play an indirect role on leukemogenesis by promoting overload. It is therefore important to evaluate the status in this patient population.


title: Identification of Predictive Neuroinflammatory Biomarkers of Neuro-radiological Evolution in Severe Traumatic Brain Injury

acronym: ICON-TBI

summary:
Tertiary lesions responsible of the neurological decline after severe traumatic brain injury (TBI) are partially due to a persistent neuro-inflammation directly modulated by inflammatory mediators during the acute phase and detectable by using both multimodal MRI imaging and biological biomarkers during the acute phase after traumatic brain injury.

The main objective is to identify if the level of IL-1beta in cerebrospinal fluid predict in a reliable and reproducible way, the neuro-radiological evolution evaluated by the comparison of a quantitative MRI performed in post-resuscitation and at one year (quantitative ΔIRM) in traumatic brain injuried patients.

The secondary objectives are:

To understand the links between the acute and chronic neuro-inflammatory phase in a population of TBI,
To explore the contribution of the adaptive immune response in the persistent activation of the immune response,
To Examine the links between persistent neuroinflammation, clinical deterioration and neuroimaging,
To establish a correlation between the pathology and the physio-pathology of TBI.

location_facility: Anesthesy department - Hôpital Pitié Salpêtrière


title: Population-Based Pharmacokinetic / Pharmacodynamic Modeling of the Effect of Free Ticagrelor Fraction on the Platelet Membrane in Post Myocardial Infarction Patients

acronym: PLATIME

summary:
The purpose of this study is to assess:

the population pharmacokinetics of unbound ticagrelor and its metabolite in acute coronary syndrome patients treated by ticagrelor
ticagrelor and its metabolite levels by LC-MS/MS

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Time Trend Analysis of Pulmonary Embolism Diagnosis With SPECT V/Q: a Single Institution Observational Study From 2011 to 2016

acronym: TOMOBS

summary: Following the implementation of SPECT V/Q imaging for PE diagnosis, the investigators previously conducted an observational study over the period 2011-2013 that showed the safety of a diagnostic management based on SPECT V/Q to rule out PE. However, PE prevalence was high (28%), which may seem a bit high as compared with other recent studies. The hypothesis was that the use of SPECT V/Q may be responsible for an overdiagnosis of PE, especially at the implementation phase of the test. The aim of this study was to perform a time trend analysis of the evolution over the years of PE diagnosis with SPECT V/Q.

lead_sponsor: University Hospital, Brest


title: Transversus Abdominis Plane (TAP) Block in Open Abdominal Aortic Surgery : Randomized Controlled Doubled-blind Trial Comparing Ropivacaine 0.2% Versus Placebo

acronym: TAP-CACAO

summary: The primary outcome of this study was the evaluation of the efficacy of TAP block on pain intensity following open abdominal aortic surgery.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Cardiovascular and thoracic surgery unit, CHU Dijon


title: Combined Thoracic Ultrasound Using Speckle Tracking for the Prediction of Weaning Failure : a Prospective Multicenter Study

summary: Deciding the optimal timing for extubation in patients who are mechanically ventilated can be challenging, and traditional weaning predictor tools are not accurate. Recent studies suggest that isolated sonographic assessment of the respiratory and cardiac function (ie diastolic function and filling pressure), in mechanically ventilated patients may assist in identifying patients at risk of weaning failure. Recently, the association of conventional echocardiography and lung ultrasound showed promising results for the prediction of post extubation distress. Speckle Tracking is an emerging tool in intensive care medicine that has never been investiguated for the prediction of weaning failure. It could early detects diastolic dysfunction and and elevated filling pressure. Of more, speckle tracking is known to be less operator dependant. The main objective of our study is to evaluate the diagnosis accuracy of speckle tracking echocardiography performed during a weaning trial to predict weaning failure. The secondary objectives are to assess the diagnosis accuracy of combined heart and lung ultrasound to predict weaning failure.

location_facility: Assistance Publique Hôpitaux de Marseille


title: Monocentric Pilot Study, for a Randomized, Crossover, Blinded Trial: Comparison of the Therapeutic Efficacy of Low Frequency Repeated Transcranial Magnetic Stimulation on Cortical Area 9 Compared to Brodmann Area 46 in the Treatment of Depressive Disorders.

acronym: rTMS

summary:
Repetitive transcranial magnetic stimulation (rTMS) is a new therapeutic tool used in psychiatry. Non-invasive, well tolerated and requiring no premedication, it is performed on an outpatient basis. The principle of this technique is to stimulate the cerebral cortex from an electromagnetic coil placed on the scalp. Unlike electroconvulsive therapy, rTMS induces an electrical current on a well-defined region of the cerebral cortex.

In psychiatry, this technique is mainly considered in the treatment of depressive disorders resistant to antidepressant medication. The brain target, obtained from brain imaging data in depressed patients, is the dorsolateral prefrontal cortex (DLPFC). The Food and Drug Administration (FDA) has recognized the interest of rTMS for treating depressive disorders (October 7, 2008).

However, some stimulation parameters still need to be optimized before rTMS can be considered a therapeutic method in its own right and used routinely. Indeed, its effectiveness over time has not yet been evaluated, and rTMS has shown a lack of reproducibility between subjects [Foucher, 2007]. Finally, the therapeutic results of rTMS are very modest whatever the study [Daskalakis, 2008]. Additional studies are therefore needed to optimize stimulation parameters.


title: Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.

acronym: HAGED

summary:
Diabetes is a major public health problem that has been growing steadily in recent years. Its prevalence is very high in the elderly, in whom there is an increased risk of hypoglycemia.

Hypoglycaemia in elderly diabetics has serious consequences:

increased mortality,
increased cardiovascular morbidity,
increased risk of falling,
impairment of quality of life.
Hypoglycaemia is also a risk factor for dementia in type 2 diabetes. The frequency of asymptomatic and atypical hypoglycemia has been shown to be greater in the elderly, but the exact prevalence of hypoglycemia in the elderly remains unknown.

Elderly diabetic patients in institutions are particularly fragile and have more frequent cognitive problems than non-diabetic subjects. A study conducted in this population of patients showed that a third of them had HbA1C <6.5%, which suggests a higher frequency of hypoglycemia though the figures were not available.

We therefore decided to conduct a study to assess the frequency of hypoglycemia in order to better understand the contributing factors and to improve the management of this fragile population.


title: Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia (ART-CONNECT)

acronym: ART-CONNECT

summary: A stroke located in the left parieto-temporal junction is associated, in aphasic right-handed patients, with a poor prognosis for language recovery. The role of the right hemisphere in recovering post-stroke aphasia is still controversial. Our hypothesis, based on recent work in imaging, is that early activation of the right hemisphere linked to the practice of the visual arts could facilitate language recovery in extended posterior left strokes that completely disrupt language areas.

location_facility: Groupe Hospitalier Pitié-Salpêtrière, Soins de Suite et Réadaptation


title: External Validation of the RESAS (REnnes Septic Arthritis Score) Septic Arthritis Prognosis Score in an Acute Arthritis Cohort of Less Than 30 Days

acronym: SYNOLACTATES +

summary: Observational study

lead_sponsor: Rennes University Hospital


title: Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections

acronym: Predict-UTI

summary: Urinary tract infections affect more than 130 million people worldwide each year. Almost 50% of women will have at least one urinary tract infection during their lifetime, usually cystitis. Half of them will have recurrent cystitis. Antibiotics are the first-line treatment for cystitis, but their effectiveness is decreasing due to the rapid spread of multi-resistant uro-pathogenic bacteria. The objective of this study is to identify blood biomarkers associated with a high risk of recurrent cystitis. Immune system cells, and more specifically innate immunity cells, play a key role in controlling urinary tract infections. In addition, clinical studies have shown that there is a high inter-individual variability in the ability of innate immune cells to respond to different stimuli. We therefore hypothesized that there was an association between the risk of recurrent cystitis and a deficiency of certain immune cell types in producing certain pro-inflammatory cytokines, including TNF-α, in response to one or more bacterial stimuli, particularly flagellin.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Hôpital de l'Archet 1 - CHU de Nice - Service d'Infectiologie


title: Evaluation of Kidney Graft's Fibrosis With Real Time Shear-wave Elastography

acronym: Elastogreffe

summary:
Kidney graft's fibrosis is correlated with prognostic of kidney's graft, wathever the initial etiology. Actually, that evaluation is based on histologic score of Banff FI/AT (0 to III). It is obtained thanks to punction-biopsy, which is invasive and can lead complications. This exam is systematic on M3 of the transplantation.

Tissue's fibrosis is a proliferation of extracellular matrix, leading to an increase of fibrosed tissue rigidity.

Elastography is an ultrasound technique allowing evaluation of tissues' rigidity.

The purpose is the validation of elastograhpy, innovative and non -invasive technique, and more specifically Shear Wave Elastography (SWE). For this, strain ratio (SR) could improve intra-operator variability and estimate fibrosis' degree of kidney's graft.

lead_sponsor: University Hospital, Tours


title: Study of the Link Between Retinal Atrophy and Demyelinating Inflammatory Processes on Visual Pathways in Relapsing Multiple Sclerosis in Magnetic Resonance Imaging and Optical Coherence Tomography

acronym: VWIMS

summary: This study will interest in the pathophysiology of silent retinal axonal loss in multiple sclerosis. Recent studies have suggested that silent retinal axonal loss (no past history of optic neuritis [ON]) may be due to inflammatory lesions within the optic radiations and a transsynaptic degenerative process. The objective is to measure the exact role of silent optic nerve lesion in the occurrence of silent retinal axonal loss by performing OCT, brain and optic nerve MRI in a cohort of patients without recent disease activity.

ReferenceCitation: Hodel J, Outteryck O, Bocher AL, Zéphir H, Lambert O, Benadjaoud MA, Chechin D, Pruvo JP, Vermersch P, Leclerc X. Comparison of 3D double inversion recovery and 2D STIR FLAIR MR sequences for the imaging of optic neuritis: pilot study. Eur Radiol. 2014 Dec;24(12):3069-75. doi: 10.1007/s00330-014-3342-3. Epub 2014 Aug 23.

ReferenceCitation: Hadhoum N, Hodel J, Defoort-Dhellemmes S, Duhamel A, Drumez E, Zéphir H, Pruvo JP, Leclerc X, Vermersch P, Outteryck O. Length of optic nerve double inversion recovery hypersignal is associated with retinal axonal loss. Mult Scler. 2016 Apr;22(5):649-58. doi: 10.1177/1352458515598021. Epub 2015 Jul 30.

ReferenceCitation: Gabilondo I, Martínez-Lapiscina EH, Martínez-Heras E, Fraga-Pumar E, Llufriu S, Ortiz S, Bullich S, Sepulveda M, Falcon C, Berenguer J, Saiz A, Sanchez-Dalmau B, Villoslada P. Trans-synaptic axonal degeneration in the visual pathway in multiple sclerosis. Ann Neurol. 2014 Jan;75(1):98-107. doi: 10.1002/ana.24030. Epub 2014 Jan 2.

ReferenceCitation: Jindahra P, Petrie A, Plant GT. The time course of retrograde trans-synaptic degeneration following occipital lobe damage in humans. Brain. 2012 Feb;135(Pt 2):534-41. doi: 10.1093/brain/awr324. Epub 2012 Feb 1.

ReferenceCitation: Petzold A, Balcer LJ, Calabresi PA, Costello F, Frohman TC, Frohman EM, Martinez-Lapiscina EH, Green AJ, Kardon R, Outteryck O, Paul F, Schippling S, Vermersch P, Villoslada P, Balk LJ; ERN-EYE IMSVISUAL. Retinal layer segmentation in multiple sclerosis: a systematic review and meta-analysis. Lancet Neurol. 2017 Oct;16(10):797-812. doi: 10.1016/S1474-4422(17)30278-8. Epub 2017 Sep 12. Review.

ReferenceCitation: Martinez-Lapiscina EH, Arnow S, Wilson JA, Saidha S, Preiningerova JL, Oberwahrenbrock T, Brandt AU, Pablo LE, Guerrieri S, Gonzalez I, Outteryck O, Mueller AK, Albrecht P, Chan W, Lukas S, Balk LJ, Fraser C, Frederiksen JL, Resto J, Frohman T, Cordano C, Zubizarreta I, Andorra M, Sanchez-Dalmau B, Saiz A, Bermel R, Klistorner A, Petzold A, Schippling S, Costello F, Aktas O, Vermersch P, Oreja-Guevara C, Comi G, Leocani L, Garcia-Martin E, Paul F, Havrdova E, Frohman E, Balcer LJ, Green AJ, Calabresi PA, Villoslada P; IMSVISUAL consortium. Retinal thickness measured with optical coherence tomography and risk of disability worsening in multiple sclerosis: a cohort study. Lancet Neurol. 2016 May;15(6):574-84. doi: 10.1016/S1474-4422(16)00068-5. Epub 2016 Mar 18.


title: Efficacity of a Sustained Weekly Psychological Intervention for Adolescents and Young Adults Attending to Local Missions for Reinsertion, on Reducing the Suicidal Ideations, Depression Level and Improving Reinsertion Compared to Usual Care

acronym: MLADO

summary:
Suicide is the third leading cause of death in adolescents and young adults in the United States and the second leading cause in European countries.

Depressive disorders are consistently the most prevalent psychiatric disorder among adolescents who attempt suicide with a prevalence ranging from 49% to 64%. Depression in adolescent and young adults is a multifactorial phenomenon, as is the risk of suicidal attempt. To address such problems, effective and accessible treatment is needed, as recommended by the French Health Authority (HAS).

Our primary objective is to demonstrate that a weekly psychotherapeutic intervention reduces the depression level.

The primary assessment criterion is the variation of the clinician Adolescent Depression Rating Scale (ADRSc) from randomisation to month 6.

The study also aims comparing in the 2 randomised groups

ADRS depression global score (clinician and subject) at 0, 3, 9 and 12 months
Number of suicidal attempts and self-harm attempts at 6 and 12 months
Number of drop-out at 6 and 12 months
Beck's Hopelessness Scale at 0, 3, 6, 9 and 12 months
Global score on the GHQ-28 and scores on the 4 subscales (Somatization, Anxiety and Insomnia, Social dysfunction, Depressive mood) at 0, 3, 6, 9 and 12 months.
Working AIliance Inventory (WAI) score at 0, 3, 6, 9 and 12 months


title: Validation of a Self-questionnaire in French on the Use of the Upper Limbs in Patients With Multiple Sclerosis

acronym: MS-SEP

summary: Multiple sclerosis (MS) is an inflammatory and demyelinating disease of the central nervous system that causes disability in young adults. This disability can take many forms depending on the neurological systems affected: disability walking, cognitive impairment or disability in the upper limbs. The development of validated measurement tools for these different disabilities is essential for the follow-up of patients in clinical routine and for the evaluation of new therapies.

ReferenceCitation: Samejima F. Estimation of latent ability using a response pattern of graded scores. Richmond, VA: The Psychometric Society, 1969.