title: Prevention of Mental Health Problems Among Persons Without Personal Housing in the Context of the COVID-19 Epidemic: a Randomized Controlled Trial

acronym: RESPOND-FR

summary:
The Covid-19 pandemic is having a great impact on the long-term mental health and well-being. Reports on the levels of psychological distress are concerning. This can be due to the pandemic, as well as social distancing, employment and economic consequences.

Healthcare workers, the elderly, youths, and persons experiencing socio-economic adversity are at risk of developing psychological distress. In this context, healthcare systems risk being overcharged, facing a growing demand.

Cognitive Behaviour Therapies managing psychological distress have been formally recommended. WHO has implemented different escalated psychosocial interventions, such as Problem Management Plus, PM+; Doing What Matters in Times of Stress, DWM; and Psychological First Aid, PFA. Their aim is to help individuals manage their stress in order to decrease the occurrence of psychological problems. They do not replace care for severe mental health disorders, but can prevent the deterioration of individuals' mental health.

PM+ has previously been found to be effective in situations of endemic conflict or violence in Pakistan and Kenya. The implementation of this program in Europe is being evaluated in the EU H2020 project STRENGHTS, focused in migrants from Syria. In the present trail, the investigators aim to further test its effectiveness in the context of psychological distress resulting from the COVID-19 pandemic.

Prior to the present trial, the investigators conducted a qualitative research study among potential beneficiaries and healthcare workers to evaluate the feasibility of DWM and PM+, which showed interest in stepped-care interventions in mental health, particularly if they are technology-based (mobile phones).

Our study is embedded in the larger, EU H2020 CORONAVIRUS-funded RESPOND project (Grant Agreement No 101016127). This project granted funding for a multicentric, single-blinded, randomised, controlled trial to evaluate the effectiveness of the stepped-care DWM and PM+ program vs. Care as Usual (CAU). In France, the investigators will focus on persons experiencing socioeconomic adversity, as defined by unstable housing conditions. A recent study showed that most of them are migrants. All subjects (210) will receive PFA and CAU. In addition to PFA and CAU, the treatment group (105 subjects) will receive the intervention DWM (with or without PM+). The primary outcome will be the decrease in symptoms of anxiety and depression from baseline to two-months follow-up.

ReferenceCitation: A-Tjak JG, Davis ML, Morina N, Powers MB, Smits JA, Emmelkamp PM. A meta-analysis of the efficacy of acceptance and commitment therapy for clinically relevant mental and physical health problems. Psychother Psychosom. 2015;84(1):30-6. doi: 10.1159/000365764. Epub 2014 Dec 24.

ReferenceCitation: Altman DG. Endorsement of the CONSORT statement by high impact medical journals: survey of instructions for authors. BMJ. 2005 May 7;330(7499):1056-7.

ReferenceCitation: Ashbaugh AR, Houle-Johnson S, Herbert C, El-Hage W, Brunet A. Psychometric Validation of the English and French Versions of the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). PLoS One. 2016 Oct 10;11(10):e0161645. doi: 10.1371/journal.pone.0161645. eCollection 2016.

ReferenceCitation: Ashworth M, Shepherd M, Christey J, Matthews V, Wright K, Parmentier H, et al. A client-generated psychometric instrument: The development of 'PSYCHLOPS.' Couns Psychother Res [Internet]. 2004;4(2):27-31. Available from: https://www.tandfonline.com/doi/abs/10.1080/14733140412331383913

ReferenceCitation: Baggaley RF, Ganaba R, Filippi V, Kere M, Marshall T, Sombié I, Storeng KT, Patel V. Detecting depression after pregnancy: the validity of the K10 and K6 in Burkina Faso. Trop Med Int Health. 2007 Oct;12(10):1225-9.

ReferenceCitation: Baillie AJ. Predictive gender and education bias in Kessler's psychological distress Scale (k10). Soc Psychiatry Psychiatr Epidemiol. 2005 Sep;40(9):743-8. Epub 2005 Sep 5.

ReferenceCitation: Banbury A, Nancarrow S, Dart J, Gray L, Parkinson L. Telehealth Interventions Delivering Home-based Support Group Videoconferencing: Systematic Review. J Med Internet Res. 2018 Feb 2;20(2):e25. doi: 10.2196/jmir.8090.

ReferenceCitation: Blavatnik School of Government University of Oxford,

ReferenceCitation: Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.

ReferenceCitation: Boyd L, Baker E, Reilly J. Impact of a progressive stepped care approach in an improving access to psychological therapies service: An observational study. PLoS One. 2019 Apr 9;14(4):e0214715. doi: 10.1371/journal.pone.0214715. eCollection 2019.

ReferenceCitation: Bryant RA, Schafer A, Dawson KS, Anjuri D, Mulili C, Ndogoni L, Koyiet P, Sijbrandij M, Ulate J, Harper Shehadeh M, Hadzi-Pavlovic D, van Ommeren M. Effectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: A randomised clinical trial. PLoS Med. 2017 Aug 15;14(8):e1002371. doi: 10.1371/journal.pmed.1002371. eCollection 2017 Aug.

ReferenceCitation: Busch-Geertsema V, Edgar W. Homelessness and homeless policies in Europe: Lessons from research [Internet]. Brussels; 2010. Available from: http://www.sociallabel.be/sites/default/files/doc/116829_pod_broch_homelessnes_eng_v3_0.pdf

ReferenceCitation: Cambridge University Press. Bootstrap Methods and Their Applications. Cambridge; 1997. 582 p.

ReferenceCitation: Campion J, Bhugra D, Bailey S, Marmot M. Inequality and mental disorders: opportunities for action. Lancet. 2013 Jul 20;382(9888):183-4. doi: 10.1016/S0140-6736(13)61411-7.

ReferenceCitation: Chisholm D, Knapp MR, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B. Client Socio-Demographic and Service Receipt Inventory--European Version: development of an instrument for international research. EPSILON Study 5. European Psychiatric Services: Inputs Linked to Outcome Domains and Needs. Br J Psychiatry Suppl. 2000;(39):s28-33.

ReferenceCitation: Chmitorz A, Kurth K, Mey LK, Wenzel M, Lieb K, Tüscher O, Kubiak T, Kalisch R. Assessment of Microstressors in Adults: Questionnaire Development and Ecological Validation of the Mainz Inventory of Microstressors. JMIR Ment Health. 2020 Feb 24;7(2):e14566. doi: 10.2196/14566. Erratum in: JMIR Ment Health. 2020 May 4;7(5):e18626.

ReferenceCitation: Cohen S, Williamson G. Perceived stress in a probability sample of the United States [Internet]. Vol. 13, The Social Psychology of Health. 1988. p. 31-67. Available from: http://doi.apa.org/psycinfo/1988-98838-002

ReferenceCitation: Cuijpers P, Muñoz RF, Clarke GN, Lewinsohn PM. Psychoeducational treatment and prevention of depression: the "Coping with Depression" course thirty years later. Clin Psychol Rev. 2009 Jul;29(5):449-58. doi: 10.1016/j.cpr.2009.04.005. Epub 2009 Apr 18. Review.

ReferenceCitation: Czachowski S, Seed P, Schofield P, Ashworth M. Measuring psychological change during cognitive behaviour therapy in primary care: a Polish study using 'PSYCHLOPS' (Psychological Outcome Profiles). PLoS One. 2011;6(12):e27378. doi: 10.1371/journal.pone.0027378. Epub 2011 Dec 15.

ReferenceCitation: Dawson KS, Schafer A, Anjuri D, Ndogoni L, Musyoki C, Sijbrandij M, van Ommeren M, Bryant RA. Feasibility trial of a scalable psychological intervention for women affected by urban adversity and gender-based violence in Nairobi. BMC Psychiatry. 2016 Nov 18;16(1):410.

ReferenceCitation: de Graaff AM, Cuijpers P, Acarturk C, Bryant R, Burchert S, Fuhr DC, Huizink AC, de Jong J, Kieft B, Knaevelsrud C, McDaid D, Morina N, Park AL, Uppendahl J, Ventevogel P, Whitney C, Wiedemann N, Woodward A, Sijbrandij M. Effectiveness of a peer-refugee delivered psychological intervention to reduce psychological distress among adult Syrian refugees in the Netherlands: study protocol. Eur J Psychotraumatol. 2020 Jan 20;11(1):1694347. doi: 10.1080/20008198.2019.1694347. eCollection 2020.

ReferenceCitation: Department of Mental Health and Substance Abuse. PROBLEM MANAGEMENT PLUS (PM+): Individual psychological help for adults impaired by distress in communities exposed to adversity [Internet]. Geneva; 2016. Available from: https://www.who.int/publications/i/item/WHO-MSD-MER-16.2%0Awww.who.int

ReferenceCitation: den Boer PC, Wiersma D, Van den Bosch RJ. Why is self-help neglected in the treatment of emotional disorders? A meta-analysis. Psychol Med. 2004 Aug;34(6):959-71.

ReferenceCitation: Department of Mental Health and Substance Abuse. Scalable psychological interventions for people in communities affected by adversity. A new area of mental health and psychosocial work at WHO [Internet]. 2017. Available from: https://apps.who.int/iris/handle/10665/254581

ReferenceCitation: Donker T, Comijs H, Cuijpers P, Terluin B, Nolen W, Zitman F, Penninx B. The validity of the Dutch K10 and extended K10 screening scales for depressive and anxiety disorders. Psychiatry Res. 2010 Mar 30;176(1):45-50. doi: 10.1016/j.psychres.2009.01.012. Epub 2010 Jan 13.

ReferenceCitation: Donker T, van Straten A, Marks I, Cuijpers P. Quick and easy self-rating of Generalized Anxiety Disorder: validity of the Dutch web-based GAD-7, GAD-2 and GAD-SI. Psychiatry Res. 2011 Jun 30;188(1):58-64. doi: 10.1016/j.psychres.2011.01.016. Epub 2011 Feb 19.

ReferenceCitation: Dragan M, Grajewski P, Shevlin M. Adjustment disorder, traumatic stress, depression and anxiety in Poland during an early phase of the COVID-19 pandemic. Eur J Psychotraumatol. 2021 Jan 26;12(1):1860356. doi: 10.1080/20008198.2020.1860356. eCollection 2021.

ReferenceCitation: Dua T, Barbui C, Clark N, Fleischmann A, Poznyak V, van Ommeren M, Yasamy MT, Ayuso-Mateos JL, Birbeck GL, Drummond C, Freeman M, Giannakopoulos P, Levav I, Obot IS, Omigbodun O, Patel V, Phillips M, Prince M, Rahimi-Movaghar A, Rahman A, Sander JW, Saunders JB, Servili C, Rangaswamy T, Unützer J, Ventevogel P, Vijayakumar L, Thornicroft G, Saxena S. Evidence-based guidelines for mental, neurological, and substance use disorders in low- and middle-income countries: summary of WHO recommendations. PLoS Med. 2011 Nov;8(11):e1001122. doi: 10.1371/journal.pmed.1001122. Epub 2011 Nov 15.

ReferenceCitation: Edgar, B., Doherty, J. & Meert, H. 2004. Immigration And Homelessness In Europe, Policy Press.

ReferenceCitation: Epping-Jordan JE, Harris R, Brown FL, Carswell K, Foley C, García-Moreno C, Kogan C, van Ommeren M. Self-Help Plus (SH+): a new WHO stress management package. World Psychiatry. 2016 Oct;15(3):295-296. doi: 10.1002/wps.20355.

ReferenceCitation: Fledderus M, Bohlmeijer ET, Pieterse ME, Schreurs KM. Acceptance and commitment therapy as guided self-help for psychological distress and positive mental health: a randomized controlled trial. Psychol Med. 2012 Mar;42(3):485-95. doi: 10.1017/S0033291711001206. Epub 2011 Jul 11.

ReferenceCitation: Foa, E. B. (1995) Posttraumatic stress diagnostic scale (PDS);, Minneapolis: National Computer Systems.

ReferenceCitation: Galenkamp H, Stronks K, Snijder MB, Derks EM. Measurement invariance testing of the PHQ-9 in a multi-ethnic population in Europe: the HELIUS study. BMC Psychiatry. 2017 Oct 24;17(1):349. doi: 10.1186/s12888-017-1506-9.

ReferenceCitation: Gambin M, Sękowski M, Woźniak-Prus M, Wnuk A, Oleksy T, Cudo A, Hansen K, Huflejt-Łukasik M, Kubicka K, Łyś AE, Gorgol J, Holas P, Kmita G, Łojek E, Maison D. Generalized anxiety and depressive symptoms in various age groups during the COVID-19 lockdown in Poland. Specific predictors and differences in symptoms severity. Compr Psychiatry. 2021 Feb;105:152222. doi: 10.1016/j.comppsych.2020.152222. Epub 2020 Dec 25.

ReferenceCitation: Gandubert C, Scali J, Ancelin ML, Carrière I, Dupuy AM, Bagnolini G, Ritchie K, Sebanne M, Martrille L, Baccino E, Hermès A, Attal J, Chaudieu I. Biological and psychological predictors of posttraumatic stress disorder onset and chronicity. A one-year prospective study. Neurobiol Stress. 2016 Feb 4;3:61-67. eCollection 2016 Jun.

ReferenceCitation: Garcy AM, Vågerö D. Unemployment and suicide during and after a deep recession: a longitudinal study of 3.4 million Swedish men and women. Am J Public Health. 2013 Jun;103(6):1031-8. doi: 10.2105/AJPH.2013.301210. Epub 2013 Apr 18.

ReferenceCitation: Gurría A. Virtual 2020 G20 Digital Ministers Summit on COVID-19. Vol. April. Paris: OECD; 2020.

ReferenceCitation: Hayes SC, Levin ME, Plumb-Vilardaga J, Villatte JL, Pistorello J. Acceptance and commitment therapy and contextual behavioral science: examining the progress of a distinctive model of behavioral and cognitive therapy. Behav Ther. 2013 Jun;44(2):180-98. doi: 10.1016/j.beth.2009.08.002. Epub 2011 Jun 1. Review.

ReferenceCitation: Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

ReferenceCitation: Hinz A, Klein AM, Brähler E, Glaesmer H, Luck T, Riedel-Heller SG, Wirkner K, Hilbert A. Psychometric evaluation of the Generalized Anxiety Disorder Screener GAD-7, based on a large German general population sample. J Affect Disord. 2017 Mar 1;210:338-344. doi: 10.1016/j.jad.2016.12.012. Epub 2016 Dec 18.

ReferenceCitation: Ho FY, Yeung WF, Ng TH, Chan CS. The Efficacy and Cost-Effectiveness of Stepped Care Prevention and Treatment for Depressive and/or Anxiety Disorders: A Systematic Review and Meta-Analysis. Sci Rep. 2016 Jul 5;6:29281. doi: 10.1038/srep29281. Review.

ReferenceCitation: Hobfoll SE, Watson P, Bell CC, Bryant RA, Brymer MJ, Friedman MJ, Friedman M, Gersons BP, de Jong JT, Layne CM, Maguen S, Neria Y, Norwood AE, Pynoos RS, Reissman D, Ruzek JI, Shalev AY, Solomon Z, Steinberg AM, Ursano RJ. Five essential elements of immediate and mid-term mass trauma intervention: empirical evidence. Psychiatry. 2007 Winter;70(4):283-315; discussion 316-69. doi: 10.1521/psyc.2007.70.4.283. Review.

ReferenceCitation: Inter-Agency Standing Committee. IASC Guidelines on Mental Health and Psychosocial Support in Emergency Settings [Internet]. Geneva; 2007. Available from: http://www.humanitarianinfo.org/iasc/content/products%0Ahttp://www.humanitarianinfo.org/iasc/content/products%0Ahttp://scholar.google.com/scholar?hl=en&btnG=Search&q=intitle:Iasc+Guidelines+on+Mental+Health+and+Psychosocial+support+in+Emergency+settings#0

ReferenceCitation: Kertz S, Bigda-Peyton J, Bjorgvinsson T. Validity of the Generalized Anxiety Disorder-7 scale in an acute psychiatric sample. Clin Psychol Psychother. 2013 Sep-Oct;20(5):456-64. doi: 10.1002/cpp.1802. Epub 2012 May 17.

ReferenceCitation: Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002 Aug;32(6):959-76.

ReferenceCitation: Kroenke K, Baye F, Lourens SG. Comparative validity and responsiveness of PHQ-ADS and other composite anxiety-depression measures. J Affect Disord. 2019 Mar 1;246:437-443. doi: 10.1016/j.jad.2018.12.098. Epub 2018 Dec 25.

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.

ReferenceCitation: Kroenke K, Wu J, Yu Z, Bair MJ, Kean J, Stump T, Monahan PO. Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials. Psychosom Med. 2016 Jul-Aug;78(6):716-27. doi: 10.1097/PSY.0000000000000322.

ReferenceCitation: Lace JW, Greif TR, McGrath A, Grant AF, Merz ZC, Teague CL, et al. Investigating the factor structure of the K10 and identifying cutoff scores denoting nonspecific psychological distress and need for treatment. Ment Heal Prev [Internet]. 2019;13(January):100-6. Available from: https://doi.org/10.1016/j.mhp.2019.01.008

ReferenceCitation: Lamers F, Jonkers CC, Bosma H, Penninx BW, Knottnerus JA, van Eijk JT. Summed score of the Patient Health Questionnaire-9 was a reliable and valid method for depression screening in chronically ill elderly patients. J Clin Epidemiol. 2008 Jul;61(7):679-87. doi: 10.1016/j.jclinepi.2007.07.018. Epub 2008 Feb 14.

ReferenceCitation: Le Méner E, Oppenchaim N. The Temporary Accommodation of Homeless Families in Ile-de-France: Between Social Emergency and Immigration Management 1. Eur J Homelessness [Internet]. 2012;6(1):83-103. Available from: https://www.feantsaresearch.org/download/article-4-31158086039476347447.pdf

ReferenceCitation: Legleye S, Karila L, Beck F, Reynaud M. Validation of the CAST, a general population Cannabis Abuse Screening Test. J Subst Use [Internet]. 2007;12(4):233-42. Available from: https://www.tandfonline.com/doi/abs/10.1080/14659890701476532

ReferenceCitation: Longchamps C, Ducarroz S, Crouzet L, El Aarbaoui T, Allaire C, Colleville A-C, et al. Connaissances, attitudes et pratiques liées à L'épidémie de Covid-19 et son impact chez les personnes en situation de précarité vivant en centre d'hébergement en France : Premiers Résultats de l'étude Echo. BEH [Internet]. 2021;(1):2-9. Available from: http://beh.santepubliquefrance.fr/beh/2021/Cov_1/2021_Cov_1_1.html

ReferenceCitation: Löwe B, Decker O, Müller S, Brähler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.

ReferenceCitation: Manea L, Gilbody S, McMillan D. Optimal cut-off score for diagnosing depression with the Patient Health Questionnaire (PHQ-9): a meta-analysis. CMAJ. 2012 Feb 21;184(3):E191-6. doi: 10.1503/cmaj.110829. Epub 2011 Dec 19.

ReferenceCitation: McGinty EE, Presskreischer R, Han H, Barry CL. Psychological Distress and Loneliness Reported by US Adults in 2018 and April 2020. JAMA. 2020 Jul 7;324(1):93-94. doi: 10.1001/jama.2020.9740.

ReferenceCitation: Morgan C, Knowles G, Hutchinson G. Migration, ethnicity and psychoses: evidence, models and future directions. World Psychiatry. 2019 Oct;18(3):247-258. doi: 10.1002/wps.20655.

ReferenceCitation: Murray LK, Dorsey S, Bolton P, Jordans MJ, Rahman A, Bass J, Verdeli H. Building capacity in mental health interventions in low resource countries: an apprenticeship model for training local providers. Int J Ment Health Syst. 2011 Nov 18;5(1):30. doi: 10.1186/1752-4458-5-30.

ReferenceCitation: Nosè M, Ballette F, Bighelli I, Turrini G, Purgato M, Tol W, Priebe S, Barbui C. Psychosocial interventions for post-traumatic stress disorder in refugees and asylum seekers resettled in high-income countries: Systematic review and meta-analysis. PLoS One. 2017 Feb 2;12(2):e0171030. doi: 10.1371/journal.pone.0171030. eCollection 2017.

ReferenceCitation: Okruszek Ł, Aniszewska-Stańczuk A, Piejka A, Wiśniewska M, Żurek K. Safe but Lonely? Loneliness, Anxiety, and Depression Symptoms and COVID-19. Front Psychol. 2020 Dec 4;11:579181. doi: 10.3389/fpsyg.2020.579181. eCollection 2020.

ReferenceCitation: Organisation Mondiale de la Santé. Gestion des problèmes Plus (PM+). Soutien psychosocial individuel pour adultes affectés par la détresse dans les communautés exposées à l'adversité [Internet]. Geneva; 2018. Available from: https://apps.who.int/iris/handle/10665/275831

ReferenceCitation: Organisation Mondiale de la Santé. Faire ce qui compte en période de stress : Un guide illustré [Internet]. Geneva: World Health Organisation; 2020. 132 p. Available from: https://cdn.who.int/media/docs/default-source/mental-health/sh-2020-fre-5-web.pdf?sfvrsn=90a35ada_2

ReferenceCitation: Organisation Mondiale de la santé, War Trauma Foundation, World Vision International. Les premiers secours psychologiques guide pour les travailleurs humanitaires sur le terrain [Internet]. Geneva; 2012. Available from: https://apps.who.int/iris/handle/10665/44779

ReferenceCitation: Pomerleau CS, Majchrzak MJ, Pomerleau OF. Nicotine dependence and the Fagerström Tolerance Questionnaire: a brief review. J Subst Abuse. 1989;1(4):471-7. Review.

ReferenceCitation: Price M, Szafranski DD, van Stolk-Cooke K, Gros DF. Investigation of abbreviated 4 and 8 item versions of the PTSD Checklist 5. Psychiatry Res. 2016 May 30;239:124-30. doi: 10.1016/j.psychres.2016.03.014. Epub 2016 Mar 8.

ReferenceCitation: Public Health England. Disparities in the risk and outcomes of COVID-19 [Internet]. PHE Publications. London; 2020. Available from: https://www.gov.uk/government/publications/covid-19-review-of-disparities-in-risks-and-outcomes

ReferenceCitation: Purgato M, Carswell K, Acarturk C, Au T, Akbai S, Anttila M, Baumgartner J, Bailey D, Biondi M, Bird M, Churchill R, Eskici S, Hansen LJ, Heron P, Ilkkursun Z, Kilian R, Koesters M, Lantta T, Nosè M, Ostuzzi G, Papola D, Popa M, Sijbrandij M, Tarsitani L, Tedeschi F, Turrini G, Uygun E, Välimäki MA, Wancata J, White R, Zanini E, Cuijpers P, Barbui C, Van Ommeren M. Effectiveness and cost-effectiveness of Self-Help Plus (SH+) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey: study protocols for two randomised controlled trials. BMJ Open. 2019 May 14;9(5):e030259. doi: 10.1136/bmjopen-2019-030259.

ReferenceCitation: Purić D, Vukčević Marković M. Development and validation of the Stressful Experiences in Transit Questionnaire (SET-Q) and its Short Form (SET-SF). Eur J Psychotraumatol. 2019 May 16;10(1):1611091. doi: 10.1080/20008198.2019.1611091. eCollection 2019.

ReferenceCitation: Rahman A, Hamdani SU, Awan NR, Bryant RA, Dawson KS, Khan MF, Azeemi MM, Akhtar P, Nazir H, Chiumento A, Sijbrandij M, Wang D, Farooq S, van Ommeren M. Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2609-2617. doi: 10.1001/jama.2016.17165.

ReferenceCitation: Rahman A, Riaz N, Dawson KS, Usman Hamdani S, Chiumento A, Sijbrandij M, Minhas F, Bryant RA, Saeed K, van Ommeren M, Farooq S. Problem Management Plus (PM+): pilot trial of a WHO transdiagnostic psychological intervention in conflict-affected Pakistan. World Psychiatry. 2016 Jun;15(2):182-3. doi: 10.1002/wps.20312.

ReferenceCitation: Rutter LA, Brown TA. Psychometric Properties of the Generalized Anxiety Disorder Scale-7 (GAD-7) in Outpatients with Anxiety and Mood Disorders. J Psychopathol Behav Assess. 2017 Mar;39(1):140-146. doi: 10.1007/s10862-016-9571-9. Epub 2016 Sep 10.

ReferenceCitation: Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804.

ReferenceCitation: Seeman TE, Singer BH, Rowe JW, Horwitz RI, McEwen BS. Price of adaptation--allostatic load and its health consequences. MacArthur studies of successful aging. Arch Intern Med. 1997 Oct 27;157(19):2259-68. Erratum in: Arch Intern Med 1999 Jun 14;159(11):1176.

ReferenceCitation: Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57. Review.

ReferenceCitation: Shim RS, Compton MT. The Social Determinants of Mental Health: Psychiatrists' Roles in Addressing Discrimination and Food Insecurity. Focus (Am Psychiatr Publ). 2020 Jan;18(1):25-30. doi: 10.1176/appi.focus.20190035. Epub 2020 Jan 24.

ReferenceCitation: Shoeb M, Weinstein H, Mollica R. The Harvard trauma questionnaire: adapting a cross-cultural instrument for measuring torture, trauma and posttraumatic stress disorder in Iraqi refugees. Int J Soc Psychiatry. 2007 Sep;53(5):447-63.

ReferenceCitation: Sijbrandij M, Horn R, Esliker R, O'May F, Reiffers R, Ruttenberg L, Stam K, de Jong J, Ager A. The Effect of Psychological First Aid Training on Knowledge and Understanding about Psychosocial Support Principles: A Cluster-Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Jan 11;17(2). pii: E484. doi: 10.3390/ijerph17020484.

ReferenceCitation: Smits N, Smit F, Cuijpers P, De Graaf R. Using decision theory to derive optimal cut-off scores of screening instruments: an illustration explicating costs and benefits of mental health screening. Int J Methods Psychiatr Res. 2007;16(4):219-29. doi: 10.1002/mpr.230.

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: Staufenbiel SM, Penninx BW, de Rijke YB, van den Akker EL, van Rossum EF. Determinants of hair cortisol and hair cortisone concentrations in adults. Psychoneuroendocrinology. 2015 Oct;60:182-94. doi: 10.1016/j.psyneuen.2015.06.011. Epub 2015 Jun 25.

ReferenceCitation: Sterling P, Eyer J. Biological basis of stress-related mortality. Soc Sci Med E. 1981 Feb;15(1):3-42. Review.

ReferenceCitation: Stickley A, Koyanagi A. Loneliness, common mental disorders and suicidal behavior: Findings from a general population survey. J Affect Disord. 2016 Jun;197:81-7. doi: 10.1016/j.jad.2016.02.054. Epub 2016 Mar 2.

ReferenceCitation: Sulaiman-Hill CM, Thompson SC. Selecting instruments for assessing psychological wellbeing in Afghan and Kurdish refugee groups. BMC Res Notes. 2010 Sep 8;3:237. doi: 10.1186/1756-0500-3-237.

ReferenceCitation: Suri H. Purposeful sampling in qualitative research synthesis. Qual Res J [Internet]. 2011;11(2):63-75. Available from: https://www.emerald.com/insight/content/doi/10.3316/QRJ1102063/full/html#loginreload

ReferenceCitation: Thabet AA, Abu Tawahina A, El Sarraj E, Vostanis P. Exposure to war trauma and PTSD among parents and children in the Gaza strip. Eur Child Adolesc Psychiatry. 2008 Jun;17(4):191-9. doi: 10.1007/s00787-007-0653-9.

ReferenceCitation: Young H, Harvey P. The sphere project: the humanitarian charter and minimum standards in disaster response: introduction. Disasters. 2004 Jun;28(2):99. doi: 10.1111/j.0361-3666.2004.00245.x.

ReferenceCitation: Thomson RM, Katikireddi SV. Mental health and the jilted generation: Using age-period-cohort analysis to assess differential trends in young people's mental health following the Great Recession and austerity in England. Soc Sci Med. 2018 Oct;214:133-143. doi: 10.1016/j.socscimed.2018.08.034. Epub 2018 Aug 29.

ReferenceCitation: Tol WA, Leku MR, Lakin DP, Carswell K, Augustinavicius J, Adaku A, Au TM, Brown FL, Bryant RA, Garcia-Moreno C, Musci RJ, Ventevogel P, White RG, van Ommeren M. Guided self-help to reduce psychological distress in South Sudanese female refugees in Uganda: a cluster randomised trial. Lancet Glob Health. 2020 Feb;8(2):e254-e263. doi: 10.1016/S2214-109X(19)30504-2.

ReferenceCitation: Tortelli A, Perquier F, Melchior M, Lair F, Encatassamy F, Masson C, K'ourio H, Gourevitch R, Mercuel A. Mental Health and Service Use of Migrants in Contact with the Public Psychiatry System in Paris. Int J Environ Res Public Health. 2020 Dec 15;17(24). pii: E9397. doi: 10.3390/ijerph17249397.

ReferenceCitation: Turrini G, Purgato M, Acarturk C, Anttila M, Au T, Ballette F, Bird M, Carswell K, Churchill R, Cuijpers P, Hall J, Hansen LJ, Kösters M, Lantta T, Nosè M, Ostuzzi G, Sijbrandij M, Tedeschi F, Valimaki M, Wancata J, White R, van Ommeren M, Barbui C. Efficacy and acceptability of psychosocial interventions in asylum seekers and refugees: systematic review and meta-analysis. Epidemiol Psychiatr Sci. 2019 Aug;28(4):376-388. doi: 10.1017/S2045796019000027. Epub 2019 Feb 11.

ReferenceCitation: United Nations. Policy Brief: Covid-19 and the Need for Action on Mental Health [Internet]. Geneva; 2020. Available from: https://unsdg.un.org/sites/default/files/2020-05/UN-Policy-Brief-COVID-19-and-mental-health.pdf

ReferenceCitation: University of Kent. The Unit Costs of Health and Social Care [Internet]. 2003. Available from: http://kar.kent.ac.uk/26657/

ReferenceCitation: Usher K, Bhullar N, Durkin J, Gyamfi N, Jackson D. Family violence and COVID-19: Increased vulnerability and reduced options for support. Int J Ment Health Nurs. 2020 Aug;29(4):549-552. doi: 10.1111/inm.12735. Epub 2020 May 7.

ReferenceCitation: van Spijker BA, Batterham PJ, Calear AL, Farrer L, Christensen H, Reynolds J, Kerkhof AJ. The suicidal ideation attributes scale (SIDAS): Community-based validation study of a new scale for the measurement of suicidal ideation. Suicide Life Threat Behav. 2014 Aug;44(4):408-19. doi: 10.1111/sltb.12084. Epub 2014 Feb 24.

ReferenceCitation: van Straten A, Hill J, Richards DA, Cuijpers P. Stepped care treatment delivery for depression: a systematic review and meta-analysis. Psychol Med. 2015 Jan;45(2):231-46. doi: 10.1017/S0033291714000701. Epub 2014 Mar 26. Review.

ReferenceCitation: van 't Hof E, Heim E, Abi Ramia J, Burchert S, Cornelisz I, Cuijpers P, El Chammay R, Harper Shehadeh M, Noun P, Smit F, van Klaveren C, van Ommeren M, Zoghbi E, Carswell K. Evaluating the Effectiveness of an E-Mental Health Intervention for People Living in Lebanon: Protocol for Two Randomized Controlled Trials. JMIR Res Protoc. 2021 Jan 28;10(1):e21585. doi: 10.2196/21585.

ReferenceCitation: Veer IM, Riepenhausen A, Zerban M, Wackerhagen C, Puhlmann LMC, Engen H, Köber G, Bögemann SA, Weermeijer J, Uściłko A, Mor N, Marciniak MA, Askelund AD, Al-Kamel A, Ayash S, Barsuola G, Bartkute-Norkuniene V, Battaglia S, Bobko Y, Bölte S, Cardone P, Chvojková E, Damnjanović K, De Calheiros Velozo J, de Thurah L, Deza-Araujo YI, Dimitrov A, Farkas K, Feller C, Gazea M, Gilan D, Gnjidić V, Hajduk M, Hiekkaranta AP, Hofgaard LS, Ilen L, Kasanova Z, Khanpour M, Lau BHP, Lenferink DB, Lindhardt TB, Magas DÁ, Mituniewicz J, Moreno-López L, Muzychka S, Ntafouli M, O'Leary A, Paparella I, Põldver N, Rintala A, Robak N, Rosická AM, Røysamb E, Sadeghi S, Schneider M, Siugzdaite R, Stantić M, Teixeira A, Todorovic A, Wan WWN, van Dick R, Lieb K, Kleim B, Hermans EJ, Kobylińska D, Hendler T, Binder H, Myin-Germeys I, van Leeuwen JMC, Tüscher O, Yuen KSL, Walter H, Kalisch R. Psycho-social factors associated with mental resilience in the Corona lockdown. Transl Psychiatry. 2021 Jan 21;11(1):67. doi: 10.1038/s41398-020-01150-4.

ReferenceCitation: Weathers FW, Blake DD, Schnurr PP, Marx BP, Keane TM. Clinician-administered PTSD scale for DSM-5 (CAPS-5) [Internet]. 2015. Available from: http://www.ptsd.va.gov/professional/assessment/adult-int/caps.asp

ReferenceCitation: World Health Organisation. Measuring Health and Disability. Manual for WHO Disability Assessment Schedule (WHODAS 2.0) [Internet]. Geneva; 2010. Available from: https://apps.who.int/iris/handle/10665/43974

ReferenceCitation: World Health Organization. in the COVID-19 response in the WHO European Region Vulnerable populations during COVID-19 response [Internet]. Geneva; 2020. Available from: https://www.euro.who.int/__data/assets/pdf_file/0003/446340/Factsheet-May-2020-Vulnerable-populations-during-COVID-19-response-eng.pdf

ipd_sharing_description: All data that underlie results in a publication will be shared on the RESPOND website (https://respond-project.eu/). At the end of the randomised trial, other meta-analysis can be conducted in the framework of research with individuals in unstable housing. For this reason, all data will be stocked during 15 years by the sponsor of the research (ANRS|MIE) and the investigator centre (INSERM).


title: Almitrine and Severe COVID-19 Patients in ICU [Almitrine et Patients COVID-19 en Reanimation (French)]

summary:
In severe COVID-19 pulmonary failure, the profound hypoxemia is mainly related to pulmonary vasodilation with altered hypoxic pulmonary vasoconstriction (HPV). Besides prone positioning, other non-ventilatory strategies may reduce the intrapulmonary shunt. This study has investigated almitrine, a pharmacological option used in standard care to improve oxygenation.

A case control series of mechanically ventilated confirmed COVID-19 patients was recorded.

At stable ventilatory settings, consecutive patients received two doses of almitrine (4 and 12 mcg/kg/min) at 30-45 min interval each, and were compared to 7 "control" COVID-matched patients conventionally treated.

The end-point was the reduction of intra-pulmonary shunt, with an increase in partial pressure of arterial oxygen (PaO2) and central venous oxygen saturation (ScvO2).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

ReferenceCitation: Gattinoni L, Coppola S, Cressoni M, Busana M, Rossi S, Chiumello D. COVID-19 Does Not Lead to a "Typical" Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2020 May 15;201(10):1299-1300. doi: 10.1164/rccm.202003-0817LE.

ReferenceCitation: Payen DM, Gatecel C, Plaisance P. Almitrine effect on nitric oxide inhalation in adult respiratory distress syndrome. Lancet. 1993 Jun 26;341(8861):1664.

ReferenceCitation: B'chir A, Mebazaa A, Losser MR, Romieu M, Payen D. Intravenous almitrine bismesylate reversibly induces lactic acidosis and hepatic dysfunction in patients with acute lung injury. Anesthesiology. 1998 Oct;89(4):823-30.

ipd_sharing: Undecided

ipd_sharing_description: Collaborative register on COVID-19 having benn treated with almitrine

lead_sponsor: Central Hospital, Nancy, France

lead_sponsor_type: academique

status_simplified: Completed


title: Randomized Multicentre Prospective Study of Procalcitonin-guided Treatment on Antibiotic Use and Outcome in Severe Sepsis ICU Patients Without Obvious Infection

acronym: Pro-SEPS

summary:
A recent study has demonstrated that in low respiratory infections, a strategy using prescription of antibiotics based on the pro-calcitonin level allows decreasing recourse to antibiotics by 47% without prognostic modification.

The aim is to evaluate the impact on antibiotics consumption of an algorithm using procalcitonin level in patients exhibiting severe sepsis symptomatology but without clearly identified hosted germs or infectious centre.

This multicenter study is a randomized prospective open study involving 9 ICU departments in France, comparing two strategies on antibiotherapy treatment period one based on procalcitonin level(experimental group) the other on physician's appreciation(control group)

140 adult patients should be included with a severe sepsis symptomatology, whose infectious etiology has not been proven. The main non-inclusion criterium is: the presence of a pathogen agent or infectious centre clearly identified.

The primary outcome is the rate of patients undergoing antibiotic treatment at D5.

Secondary outcomes: duration of the antibiotic treatment, mortality rate and duration in stay in intensive care ward and evolution of the SOFA score between D0, D3 and D5.

Duration of patient enrollment is 30 days.

status: Terminated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

lead_sponsor: Brahms France

location_facility:
ICU in St Etienne hospital
ICU in Rangueil hospital
ICU in Purpan hospital
ICU in Avicenne hospital
ICU in Raymond Poincaré hospital
ICU in J.Minjoz hospital
ICU in Ambroise Paré hospital
ICU in André Boulloche hospital
ICU in Centre hospitalier général

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Prospective Observational Study Conducted in France to Describe Routine Clinical Practice for Treatment naïve or Previously Treated Patients With Diabetic Macular Edema (DME) Who Are Starting IVT Aflibercept

acronym: APOLLON

summary:
The main objectives of this observational study were to describe outcomes, monitoring and treatment patterns of patients with diabetic macular edema in routine clinical practice who are either treatment naïve patients or previously treated patients. The total study population was evaluated as well as the two subgroups (previously treated patients and treatment naïve patients).

This study was designated to answer French Health Authority (HAS Haute Autorité de Santé) requirements.

ReferenceType: derived

ReferenceCitation: Korobelnik JF, Daien V, Faure C, Tadayoni R, Giocanti-Auregan A, Dot C, Kodjikian L, Massin P; APOLLON study investigators. Two-year outcomes of the APOLLON observational study of intravitreal aflibercept monotherapy in France in patients with diabetic macular edema. Sci Rep. 2022 Oct 29;12(1):18242. doi: 10.1038/s41598-022-22838-1.

lead_sponsor: Bayer

intervention_type: Drug


title: Effect of Smoking on Activated Clotting Time Values During Coronary Angioplasty

summary: analyzing influence of smoking on patients anti-coagulation status as assessed by ACT measurements during coronary angioplasty

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

intervention_type: Procedure

status_simplified: Ongoing


title: Combined Determination of sTREM-1, PCT and CD64 in Diagnosing Sepsis: a Prospective, Bicentric Study

summary: The purpose of this study is to determine wether the combined measurement of the soluble form of TREM-1, PCT and the determination of neutrophils CD64 expression could diagnose sepsis in critically ill patients.

location_facility:
Bocage Hospital
Central hospital


title: A Multi-Center, Longitudinal, Prospective, Observational, Multi-Cohort Study of Patients With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment (LIST, Lung Initiative on Sequence Therapy)

acronym: LIST

summary:
The purpose of this trial is to describe the following, for each cohort, in real world conditions in France:

The characteristics and treatment sequence of patients treated with nivolumab
The effectiveness of nivolumab treatment
The safety profile of nivolumab
Treatment patterns (e.g. duration of treatment, subsequent treatments) of nivolumab
The patient-reported outcomes (PRO) in patients treated with nivolumab, at baseline and during follow up using the EuroQoL-5D-3L

lead_sponsor: Bristol-Myers Squibb


title: Evaluation of a New Intraoperative Gamma Camera for the Sentinel Lymph Node Procedure in Breast Cancer

summary: Aim: This study aims at evaluating the performances of an intraoperative gamma camera (field of view 10X10 cm), named CarolIReS, to detect axillary drainage and to assess the removal of sentinel lymph nodes (SLN) in breast surgery. Patients and Methods: SLN biopsy will be performed on 110 patients and the CarolIReS camera will be used preoperatively to localize SLNs. During surgery, individual removal of SLNs will be performed using a gamma probe named CarolIReS and their activity will be measured with a gamma ray counter. At the end of surgery, the CarolIReS camera will be used again to check the quality of surgery which will be followed by a surgical excision in case of remaining SLNs. Objectives: The main objective of this study is to evaluate the performances of the CarolIReS camera in assessing the axillary drainage of breast tumors and the surgical removal of SLNs. In addition, the possible correlation between the activity, the size, and the metastatic involvement of the SLNs will also be studied.Study hypothesis: Intraoperative cameras could be used to improve the efficiency of the SLN procedure

primary_purpose: Treatment

lead_sponsor: University Hospital, Strasbourg, France

location_facility: CHRU, Hôpital Civil ,Service de Gynécologie-obstétrique

intervention_type: Device


title: An Exploratory Study to Evaluate the Acceptability of PKU Explore, a Food for Special Medical Purposes, for Use in the Dietary Management of Phenylketonuria in Infants From 6 Months to 3 Years of Age With Regard to Product-acceptability, Tolerance, Phe Levels and Growth

summary: PKU explore France is an exploratory study to evaluate the acceptability of PKU explore, a food for special medical purposes, for use in the dietary management of phenylketonuria in infants from 6 months to 3 years of age, assessing participant adherence, GI tolerance, phe levels, growth and product palatability.

lead_sponsor: Vitaflo International, Ltd

intervention_type: Dietary Supplement


title: Proposal of a Method Using the PMSI and SNIIRAM National Databases to Estimate the Frequency of Physical Abuse and to Identify th Eassociated At-risk Situations and Consequences in Children Aged 0 to 5 Years in France

acronym: MENFIS

summary: The epidemiological data currently available on child abuse in France are very inadequate. They do not make it possible to know the number of child victims, nor the precise context and impact of this violence. Very often, the figures put forward are underestimated. Improving the knowledge of these situations would make it possible to develop targeted primary and secondary prevention programs. In this study, is proposed an innovative method of exploiting existing national databases, the PMSI and SNIIRAM, with the aim of 1) approaching an order of magnitude of the frequency of physical abuse in children and 2) evaluating its contexts and consequences. The PMSI is a high-quality database that has been used for many years for medical research purposes. It provides a large amount of epidemiological information and can be used to create cohorts large enough to detect rare events. The SNIIRAM/EGB data allows the recovery of all data on reimbursed consumption, such as drug treatments, biological examinations carried out or consultations (with general practitioners or specialists).

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Multidisciplinary Consultation at the GHM Hospital of Grenoble (France) for the Establishment of an Oral Anti-cancer Drug Therapy : Feasibility, Security, and Evaluation of Patients' and City Health Professionals' Satisfaction.

acronym: MinOS

summary:
During the last few years, the medical care of oncohematologic cancers diagnosed patients was shaken by the arrival of new therapies : targeted therapies. Very efficient, these therapies use the oral pathway in most cases, and are taken at home. These treatments show plenty of drug interactions and side effects aren't rare and require, in their own, a rigorous follow up in order to reduce their occurrence, intensity and their impact on patients' quality of life. A bad management of the treatment could lead to an inacceptable toxicity, or to its premature interruption.

With all the new administration and follow up strains in mind, we want to elaborate the medical pathway structure for these patients by reinforcing the nurse coordination and by integrating another healthcare professional : the hospital pharmacist, which is a professional especially implicated in the drug delivery, the control of drug interactions and medical advices relative to the given drug.

Private healthcare professionals (referring physicians, pharmacists, private nurses), unsufficiently trained and informed about these new treatments and their side effects, are asking for further information concerning the drugs prescribed to their patients, and are willing to keep open a communication line for the home follow up.

These patients, who are autonomously taking their medication, are in need to be informed and supported to insure the good management of the drug, while taking in account their environment, their knowledge of their cancer and treatment and also of all the issues that could occur during their therapy, in order to resolve them.

We propose a multidisciplinary medical care taking place at the very beginning of an oral therapy treatment, in order to ensure the security of the drug administration. Patients and healthcare professionals will be closely followed during the first two treatment cycles. After this, side-effects incidence are less frequent and the usual oncohematologic follow up is sufficient.

primary_purpose: Health Services Research

ReferenceCitation: Liu G, Franssen E, Fitch MI, Warner E. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol. 1997 Jan;15(1):110-5.

ReferenceCitation: Noens L, van Lierde MA, De Bock R, Verhoef G, Zachée P, Berneman Z, Martiat P, Mineur P, Van Eygen K, MacDonald K, De Geest S, Albrecht T, Abraham I. Prevalence, determinants, and outcomes of nonadherence to imatinib therapy in patients with chronic myeloid leukemia: the ADAGIO study. Blood. 2009 May 28;113(22):5401-11. doi: 10.1182/blood-2008-12-196543. Epub 2009 Apr 6.

ReferenceCitation: Eliasson L, Clifford S, Barber N, Marin D. Exploring chronic myeloid leukemia patients' reasons for not adhering to the oral anticancer drug imatinib as prescribed. Leuk Res. 2011 May;35(5):626-30. doi: 10.1016/j.leukres.2010.10.017. Epub 2010 Nov 20.

ReferenceCitation: Compaci G, Ysebaert L, Obéric L, Derumeaux H, Laurent G. Effectiveness of telephone support during chemotherapy in patients with diffuse large B cell lymphoma: the Ambulatory Medical Assistance (AMA) experience. Int J Nurs Stud. 2011 Aug;48(8):926-32. doi: 10.1016/j.ijnurstu.2011.01.008. Epub 2011 Feb 23.

ReferenceCitation: Compaci G, Rueter M, Lamy S, Oberic L, Recher C, Lapeyre-Mestre M, Laurent G, Despas F. Ambulatory Medical Assistance--After Cancer (AMA-AC): A model for an early trajectory survivorship survey of lymphoma patients treated with anthracycline-based chemotherapy. BMC Cancer. 2015 Oct 24;15:781. doi: 10.1186/s12885-015-1815-7.

lead_sponsor: Groupe Hospitalier Mutualiste de Grenoble


title: Evaluation by Oncologists of Strategies for the Prevention and Treatment of Chemotherapy-induced Peripheral Neuropathies: Observational and Cross-sectional Study

acronym: EVANEURO

summary:
Chemotherapy induced peripheral neuropathy (CIPN) is one of the most deleterious adverse effect of neurotoxic anticancer drugs affecting up to 40% of patients. These neurotoxic anticancer agents include mainly: cisplatin (bronchopulmonary cancers), oxaliplatin (colorectal cancers), paclitaxel (breast cancers and bronchopulmonary cancers), docetaxel (breast cancers and bronchopulmonary cancers) and bortezomib (multiple myeloma).

CIPN affects not only the quality of life of patients, it also has a major impact on oncology strategy, forcing oncologists to reduce dose-intensity, to stop an ongoing chemotherapy regimen and to change therapeutic strategies, with a risk of compromising patients' survival.

There is no real preventive or curative treatment (except duloxetine) for CIPN and it is not known what is the practice of oncologists in France? However, it is essential to know the degree of sensitivity of oncologists to this problem and their practice.

With this study, the investigators propose to assess the current practices of management by oncologists in France in 2019, for any type of practitioners of university hospital, or general hospital, for all type of neurotoxic anticancer drugs.

time_perspective: Cross-Sectional

ReferenceCitation: Selvy M, Pereira B, Kerckhove N, Busserolles J, Farsi F, Guastella V, Merle P, Pezet D, Balayssac D. Prevention, diagnosis and management of chemotherapy-induced peripheral neuropathy: a cross-sectional study of French oncologists' professional practices. Support Care Cancer. 2021 Jul;29(7):4033-4043. doi: 10.1007/s00520-020-05928-6. Epub 2021 Jan 5.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Leukemia Cell Cultures for Research of New Anti-cancer Therapies

summary:
The main objective of this project is not only a better understanding of the human leukemic disease but also to find new anti-leukemic or improve existing ones. This study has, the following aims:

To analyze the genetic and epigenetic regulation of the retinoic acid induced cascade which leads to the expression of TRAIL in blood cells of patients with acute leukemia. This study will be complemented by the analysis of global gene expression (DNA chips) and of the DNA methylation state, and by chromatin immunoprecipitation experiences.
To determine the efficiency of inhibitors of enzymes responsible for the modification of chromatin (existing and new developments within the European consortium EPITRON coordinated by Dr Gronemeyer) as inducers of differentiation and / or apoptosis of leukemic blasts.
To explore Ikaros genic and functional abnormalities (genomic deletions, mutations, abnormal transcripts and proteins) in acute leukemia. The aim is to determine if these abnormalities may play a prognosis role.

status: Unknown status

primary_purpose: Basic Science

location_facility: Service de Pédiaterie - Hôpital de Hautepierre


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

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

lead_sponsor: Medtronic Diabetes

location_facility: APHM Marseille (Hôpital de la Conception)


title: SARS-CoV-2 in Stools Compared to Respiratory Viral Strains, in Patients Hospitalized for COVID-19.

acronym: Spread-COVID

summary: The aim of the study is to characterize and to quantify SARS-CoV-2 strains in stools, in comparison with the viral strains in respiratory samples, from patients hospitalized for COVID-19. The methods will be standard ddPCR quantifying SARS-CoV-2 RNA and next generation sequencing-whole genome sequencing. The expected results will allow us to better understand SARS-CoV-2 dynamics and compartmentalization, both in the respiratory tract and in digestive-related tissues, according to the evolution of SARS-CoV-2 variants.

study_start_date_type: Anticipated

status: Not yet recruiting

intervention_type: Diagnostic Test


type: Other Identifier

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

acronym: AURAIA

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

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

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

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

primary_purpose: Prevention

lead_sponsor: Rennes University Hospital

intervention_type: Behavioral


title: Efficacy of Alfentanyl Versus Sufentanyl in Children for Pain During Treatment by Tracheal Suction in an Intensive Care Unit.

acronym: DOLOREAPEDIA

summary: The main objective is to assess the efficacy of Alfentanil for pain in children treated by tracheal suction in pediatric intensive care units in France, compared to Sufentanyl, the current standard treatment.

ReferenceCitation: Stanik-Hutt JA, Soeken KL, Belcher AE, Fontaine DK, Gift AG. Pain experiences of traumatically injured patients in a critical care setting. Am J Crit Care. 2001 Jul;10(4):252-9.

ReferenceCitation: Ista E, van Dijk M, Tibboel D, de Hoog M. Assessment of sedation levels in pediatric intensive care patients can be improved by using the COMFORT "behavior" scale. Pediatr Crit Care Med. 2005 Jan;6(1):58-63.

ReferenceCitation: Triltsch AE, Nestmann G, Orawa H, Moshirzadeh M, Sander M, Grosse J, Genähr A, Konertz W, Spies CD. Bispectral index versus COMFORT score to determine the level of sedation in paediatric intensive care unit patients: a prospective study. Crit Care. 2005 Feb;9(1):R9-17. Epub 2004 Nov 10. Erratum in: Crit Care. 2005 Oct 5;9(5):426.

ReferenceCitation: Brocas E, Dupont H, Paugam-Burtz C, Servin F, Mantz J, Desmonts JM. Bispectral index variations during tracheal suction in mechanically ventilated critically ill patients: effect of an alfentanil bolus. Intensive Care Med. 2002 Feb;28(2):211-3. Epub 2002 Jan 12.

ReferenceCitation: Veyckemans F. [Sedation in children: how and for who?]. Arch Pediatr. 2006 Jun;13(6):835-7. Epub 2006 May 12. French.

lead_sponsor: University Hospital, Grenoble


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

acronym: Recession

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

location_facility:
CHU
CHU Henri Mondor
CHU Saint Roch
CHU Ragueil


title: Effectiveness of VistaO2 Device in Screening of Sleep Apnea/Hypopnea Syndrome

summary:
The high prevalence (9% in men and 4% in women) of sleep apnea / hypopnea syndrome (SAHS) in adults is now well documented as well as its cardiovascular repercussions. Previous studies showed a conclusive link between SAHS and severe cardiovascular diseases such as hypertension, myocardial infarction, heart failure and stroke.Then, SAHS is a public health issue in adults.

In this context, early detection of such a disease is crucial if the management is tailored to the patient, the practitioner's choice of therapy moving towards continuous positive airway pressure (CPAP) or mandibular advancement device. The detection is based on full nocturnal polysomnography or polygraphic recordings. Polysomnography remains the gold standard but it is a time consuming and costly examination. Polygraphic recording is a test that allows simplified the diagnosis of severe patients, but may not be sufficient for mild form of SAHS. Thus, the SAHS is a pathology under-diagnosed and under-treated. The validation of a technique for identifying patients most at risk to either limit the number of polysomnographic examination is requested.

primary_purpose: Diagnostic

ReferenceCitation: Chouchou F, Poupard L, Philippe C, Court-Fortune I, Barthélémy JC, Roche F. Thoracic impedance, in association with oximetry, in a multi-modal ECG Holter system is useful for screening sleep disordered breathing. Int J Cardiol. 2013 Feb 10;163(1):100-2. doi: 10.1016/j.ijcard.2012.06.082. Epub 2012 Jul 16.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de Saint-Etienne
Hôpital TENON - APHP


title: Effects of Combined Ventricular Unloading and Pharmacological Therapy on Left Ventricular Metabolic Dysfunction in Heart Failure

summary:
Cardiac function may improve in patients with end-stage heart failure who receive long-term support with ventricular assist devices (VAD). Reverse left ventricular remodeling may be sufficient in some cases to allow explantation of the VAD. However, some questions continue to await definitive answers. This study is designed to assess the myocardial recovery under VAD support with optimal pharmacological therapy (high doses [group I] of statins, beta-blockers, angiotensin-converting enzyme inhibitors versus standard doses [group II]).

The study is a randomized, single-blind trial performed at the Department of Cardiac Surgery, University of Strasbourg, France. Twenty patients with end-stage heart failure who will be supported by VAD (Thoratec paracorporeal device) as a bridge to heart transplantation will be included. Reverse left ventricular remodeling and myocardial function will be studied by: echocardiography, respiratory mitochondrial function, exercise testing, cardiac hormonal function, and inflammatory response. Myocardial biopsies will be obtained at the time of VAD implantation and heart transplantation. The follow-up will be performed every 4 weeks during the VAD support period. The hypothesis of this trial is that reverse left ventricular remodeling and myocardial function will improve under optimal medical therapy especially by a high dose statin.

location_facility: Service de Physiologie Clinique - Hôpital Civil

location_facility: Service de Chirurgie Cardiovasculaire - Hôpital Civil


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

acronym: CORSER

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

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

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

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

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

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

lead_sponsor: Institut Pasteur

location_facility: Centre Hospitalier Départemental de Vendée


title: The Contribution of Intra-arterial Thrombectomy in Acute Ischemic Stroke in Patients Treated With Intravenous Thrombolysis

acronym: THRACE

summary:
THRACE is a controled, multicenter and randomized trial.

The primary objective of this study is to determine whether a combined approach intravenous thrombolysis (IV) + Mechanical thrombectomy is superior to the reference treatment with IV thrombolysis alone, in the 3 hours of onset of symptoms in patients with occlusion of proximal cerebral arteries and with a neurological impairment accident (National Institutes of Health Stroke Scale [NIHSS] ≥ 10).

The second objective is to determine the cost-effectiveness of this procedure compared to the standard (IV thrombolysis). The assumption is that the combined approach, by improving the clinical outcome and speed recovery, allows for lower overall costs to the IV thrombolysis in 3 months and less than or at worst neutral to 1 year.

ReferenceCitation: Janvier P, Kerleroux B, Turc G, Pasi M, Farhat W, Bricout N, Benzakoun J, Legrand L, Clarençon F, Bracard S, Oppenheim C, Boulouis G, Henon H, Naggara O, Ben Hassen W. TAGE Score for Symptomatic Intracranial Hemorrhage Prediction After Successful Endovascular Treatment in Acute Ischemic Stroke. Stroke. 2022 Sep;53(9):2809-2817. doi: 10.1161/STROKEAHA.121.038088. Epub 2022 Jun 14.

ReferenceCitation: Riou-Comte N, Gory B, Soudant M, Zhu F, Xie Y, Humbertjean L, Mione G, Oppenheim C, Guillemin F, Bracard S, Richard S; THRACE investigators. Clinical imaging factors of excellent outcome after thrombolysis in large-vessel stroke: a THRACE subgroup analysis. Stroke Vasc Neurol. 2021 Dec;6(4):631-639. doi: 10.1136/svn-2020-000852. Epub 2021 Jun 8.

ReferenceCitation: Derraz I, Pou M, Labreuche J, Legrand L, Soize S, Tisserand M, Rosso C, Piotin M, Boulouis G, Oppenheim C, Naggara O, Bracard S, Clarençon F, Lapergue B, Bourcier R; ASTER and the THRACE Trials Investigators. Clot Burden Score and Collateral Status and Their Impact on Functional Outcome in Acute Ischemic Stroke. AJNR Am J Neuroradiol. 2021 Jan;42(1):42-48. doi: 10.3174/ajnr.A6865. Epub 2020 Nov 12.

ReferenceCitation: Boulouis G, Bricout N, Benhassen W, Ferrigno M, Turc G, Bretzner M, Benzakoun J, Seners P, Personnic T, Legrand L, Trystram D, Rodriguez-Regent C, Charidimou A, Rost NS, Bracard S, Cordonnier C, Oppenheim C, Naggara O, Henon H. White matter hyperintensity burden in patients with ischemic stroke treated with thrombectomy. Neurology. 2019 Oct 15;93(16):e1498-e1506. doi: 10.1212/WNL.0000000000008317. Epub 2019 Sep 13.

ReferenceCitation: Provost C, Soudant M, Legrand L, Ben Hassen W, Xie Y, Soize S, Bourcier R, Benzakoun J, Edjlali M, Boulouis G, Raoult H, Guillemin F, Naggara O, Bracard S, Oppenheim C. Magnetic Resonance Imaging or Computed Tomography Before Treatment in Acute Ischemic Stroke. Stroke. 2019 Mar;50(3):659-664. doi: 10.1161/STROKEAHA.118.023882.

ReferenceCitation: Achit H, Soudant M, Hosseini K, Bannay A, Epstein J, Bracard S, Guillemin F; THRACE Investigators. Cost-Effectiveness of Thrombectomy in Patients With Acute Ischemic Stroke: The THRACE Randomized Controlled Trial. Stroke. 2017 Oct;48(10):2843-2847. doi: 10.1161/STROKEAHA.117.017856. Epub 2017 Sep 15.

ReferenceCitation: Bracard S, Ducrocq X, Mas JL, Soudant M, Oppenheim C, Moulin T, Guillemin F; THRACE investigators. Mechanical thrombectomy after intravenous alteplase versus alteplase alone after stroke (THRACE): a randomised controlled trial. Lancet Neurol. 2016 Oct;15(11):1138-47. doi: 10.1016/S1474-4422(16)30177-6. Epub 2016 Aug 23. Erratum in: Lancet Neurol. 2016 Nov;15(12):1203.


title: Efficacy of Infusions of Mesenchymal Stem Cells From Wharton Jelly in the Moderate to Severe SARS-Cov-2 Related Acute Respiratory Distress Syndrome (COVID-19): A Phase IIa Double-blind Randomized Controlled Trial

summary:
Mesenchymal stem cells (MSCs) are of potential help in acute respiratory distress syndrome (ARDS), due to their anti-inflammatory properties.

The investigators will analyze the effect of 3 iterative infusions of ex vivo expanded Wharton's Jelly MSCs (total dose 2.10^6/kg) in patients with ARDS due to COVID19, who require mechanical ventilation.

intervention_type: Biological


title: Assessment of the Impact of Body Position on Diaphragmatic Excursion in Obese Patients to Improve Proactice in Respiratory Kinesitherapy

acronym: EXDECHO

summary:
The EXDECHO study is the first randomized study evaluating the effect of four body positions on diaphragmatic excursion in obese patients by ultrasound.

The investigators suppose that the course of the right diaphragmatic hemicupola would be increased by an increasingly horizontal position (gradual increase in the diaphragmatic excursion from standing to lying down).

If this hypothesis is confirmed, kinesitherapists will have more informed positioning choices to improve the effectiveness of respiratory rehabilitation.

primary_purpose: Other

location_facility: Centre Hospitalier Régional Universitaire de Nancy


title: Evolution of Aqueous Flare in Rhegmatogenous Retinal Detachments Treated With Gas or Silicone Oil Tamponade.

acronym: FLADESIL

summary:
To examine and to compare the evolution of aqueous flare from presentation until the third postoperative month in a series of consecutive patients who underwent primary vitrectomy for rhegmatogenous retinal detachment (RRD), in 4 groups of patients :

Group 1 : 48 eyes primarily treated with gas tamponade
Group 2 : 11 eyes primarily treated with silicone oil tamponade
Sub-Group G1RG : 8 eyes among Group 1 treated with gas after relapse
Sub-Group G1RS : 3 eyes among Group 1 treated with silicone oil after relapse


summary: Tourette syndrome is rare. In France, about 3000 patients have a severe form of the disease. The aim of this study is to collect clinical characteristics in 200 patients with Tourette syndrome.

ReferenceCitation: Worbe Y, Mallet L, Golmard JL, Béhar C, Durif F, Jalenques I, Damier P, Derkinderen P, Pollak P, Anheim M, Broussolle E, Xie J, Mesnage V, Mondon K, Viallet F, Jedynak P, Ben Djebara M, Schüpbach M, Pelissolo A, Vidailhet M, Agid Y, Houeto JL, Hartmann A. Repetitive behaviours in patients with Gilles de la Tourette syndrome: tics, compulsions, or both? PLoS One. 2010 Sep 24;5(9):e12959. doi: 10.1371/journal.pone.0012959.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: Centre d'Investigation Clinique-HÔPITAL PITIÉ-SALPETRIERE


title: Neuropsychological Assessment of Remediation for Cognitive Impairment in Schizophrénie

acronym: NARCIS

summary: This study evaluates the effect of a cognitive remediation program designed for patients suffering from a schizophrenia spectrum disorder ; on neurocognitive, social cognitive and metacognitive functions. In this double-blind (patients, outcomes assessors) controlled randomized trial the investigators compare patients receiving Ecological Cognitive training program for schizophrenia spectrum disorder [ECo-Sz] to patients benefiting from recovery-oriented therapy [ThOR]. Patients are treated for two months and monitored for four months.

lead_sponsor: Centre hospitalier de Ville-Evrard, France

location_facility:
Ch Ville Evrard
URC Ville Evrard


type: Registry Identifier

title: Uterine Artery Embolization For Uterine Pathology: What Impact On Fertility?

acronym: FERTI-EMBOL

summary:
Uterine leiomyomas (or fibroids) are a common disease (30% of women over 35 years of age) in women of childbearing age and can cause various symptoms such as menometrorrhagia, dysmenorrhoea, pelvic pain and heaviness, and infertility.

Uterine artery embolisation, first used in France in 1990, is a safe, effective and less invasive therapeutic technique than surgical treatment (myomectomy or hysterectomy), particularly in the case of numerous and large fibroids. This technique is validated by the French National College of Gynaecologists-Obstetricians (CNGOF) as an alternative treatment for women who do not wish to become pregnant (grade A recommendation), but at present there is little reliable data concerning fertility, the occurrence of pregnancy and the obstetrical prognosis after uterine artery embolisation for fibroids. A recent systematic review of the literature with meta-analysis published very recently showed that 40.5% of patients with a desire for pregnancy were able to become pregnant after embolisation (CI: 33.3%-48.2%) but that the rates of miscarriage, obstetric complications and low birth weight were not negligible (respectively 33.5% (95% CI: 26.3-41%), 25.4% (95% CI = 13-40.2%) and 10% (95% CI = 6.2-14.6%) (Ghanaati et al. 2020).

In France, uterine artery embolisation is performed in more than thirty centres in women who have completed their parental project. On the other hand, in the absence of consistent literature, it is performed in patients of childbearing age, when it represents the only acceptable alternative or in the event of contraindication or refusal of surgery by the patient. To our knowledge, there is no large-scale French study to date on the impact of embolisation on fertility and pregnancy outcomes.

The aim of this study is to compile a retrospective database of all cases of uterine artery embolisation for uterine pathology performed at the Georges-Pompidou European Hospital (HEGP) since 2007 and to assess the impact of embolisation on fertility in patients of childbearing age.

ipd_sharing: Yes

ipd_sharing_description: Individual participant data (IPD) that underlies results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Impact of Physiotherapy Session With or Without Non Invasive Ventilation in the Patient Benefiting From High Nasal Flow Oxygenation After Cardiac Surgery: a Pilot Study

summary:
This work consists, first of all, in making an inventory of the physiotherapy of the patient undergoing cardiac surgery under high flow oxygenation at the CHRU NANCY.

Then, in a second step, the impact of the physiotherapy on the lung ultrasound score associated or not with the NIV of the patient under OHD after cardiac surgery will be studied.

The objective is therefore to answer the following research question: what is the impact of a physiotherapy session with or without non-invasive ventilation in patients receiving high flow oxygenation after cardiac surgery on the lung ultrasound score measured by ultrasound?

Main hypothesis: Physiotherapy is associated with NIV when it is prescribed in patients undergoing high flow oxygenation after cardiac surgery.

Secondary hypothesis: Physiotherapy + NIV further improves pulmonary aeration versus physiotherapy + high flow oxygenation.

lead_sponsor: Central Hospital, Nancy, France


title: Post-operative CRP Trend May Lead to Early Diagnosis of Anastomotic Leak After Ileocolic Resection in Crohn's Disease Patients.

summary: Our aim is to analyze C-Reactive Protein trends during the post-operative course in Crohn's Disease patients having undergone ileocolic resection and primary anastomosis, for the purpose of anastomotic leak early diagnosis.


title: Remédiation Orthophonique couplée à Une Prise en Charge Proprioceptive de la Dyslexie. Etude Comparative randomisée

acronym: Pro-Pho-Dys

summary:
To show the interest of the association of proprioceptive and orthophonic care of dyslexic children. The assumption is that proprioceptive support by correcting a centrally located spatial localization instability restores the ability to automate.

It allows a gain of effectiveness of the orthophonic remediation of the reading of dyslexic children.

Interventional comparative study over 9 months, of three modes of care: Speech-language, or proprioceptive, or combined (speech therapy or proprioceptive)

ReferenceCitation: Quercia P, Quercia M, Feiss LJ, Allaert F. The distinctive vertical heterophoria of dyslexics. Clin Ophthalmol. 2015 Sep 25;9:1785-97. doi: 10.2147/OPTH.S88497. eCollection 2015.

lead_sponsor: Scalab CNRS 9193


title: Phase IV Study Comparing Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Intravenous Chemotherapy

acronym: PACPAC-EPOC

summary:
The aim of this study is to compare the humeral and thoracic implantation of a central venous access by an implantable device in patients with solids tumors who require intravenous chemotherapy. This is a monocentric randomized study. 572 patients will be recruited for 2 years. They will be randomized either in the thoracic implantation, either in the humeral implantation Due to the 1:3 randomization, 143 patients will be randomized in the humeral arm and 429 into the thoracic one. Number of complications related to the implantable device, medico-economic analysis as well as patient satisfaction will be assessed.

Every patients with solid tumor requiring medical device implantation for intravenous chemotherapy treatment will be eligible.

Both humeral and thoracic implantation of medical device are standard procedures. The randomization in a specific arm is the study procedure and is considered as an interventional study in France.

lead_sponsor: Center Eugene Marquis


title: French Renal Epidemiology and Information Network (REIN) Registry in Lorraine

acronym: REIN-LOR

summary: The Renal Epidemiology and Information Network (REIN) Registry was created in 2002 (after study pilot in 2001) to contribute to the development and evaluation of health strategies aiming at improving prevention and management of end-stage renal disease, and promoting clinical and epidemiological research in this field. It relies on a network of nephrologists, epidemiologists, patients and public health representatives, coordinated regionally and nationally.

ReferenceCitation: Lassalle M, Ayav C, Frimat L, Jacquelinet C, Couchoud C; Au Nom du Registre REIN. The essential of 2012 results from the French Renal Epidemiology and Information Network (REIN) ESRD registry. Nephrol Ther. 2015 Apr;11(2):78-87. doi: 10.1016/j.nephro.2014.08.002. Epub 2014 Nov 1.

ReferenceCitation: Couchoud C, Stengel B, Landais P, Aldigier JC, de Cornelissen F, Dabot C, Maheut H, Joyeux V, Kessler M, Labeeuw M, Isnard H, Jacquelinet C. The renal epidemiology and information network (REIN): a new registry for end-stage renal disease in France. Nephrol Dial Transplant. 2006 Feb;21(2):411-8. Epub 2005 Oct 18.

ipd_sharing_description: Open to partnership


title: Impact of a Child-Parent Preoperative Accompanying Procedure on the Anxiety of Children Aged 5 to 12 With Scheduled Surgery

acronym: I-PPOP

summary: In France, during surgery, only 4% of parents are present at induction, most often for children with disabilities with iterative interventions. Some studies have shown that the presence of parents during induction decreases the anxiety of children, while others do not. Their conclusions all advocate preparing parents for this presence in the operating room in an accompanying course.

lead_sponsor: University Hospital, Limoges


title: Evaluation of the Clinical and Biological Consequences of Levothyrox® Formula Modification

acronym: FORTHYROX

summary: The purpose of this study is to determine whether the recent excipient modification of Levothyrox® in France for a bioequivalent formula has clinical and biological consequence for the patients. The investigators also plan to describe the patient journey in terms of levothyroxine based drugs since this formula modification of Levothyrox®.


title: Trans-RosaLEE Study: a Biomarker-directed, Translational Study of High-throughput Molecular Profiling of HR+/HER2- Metastatic Breast Cancer Treated With Endocrine Therapy and Ribociclib.

acronym: TransRosaLEE

summary:
Hormone receptor (HR)-positive and HER2-negative (HR+/HER2-) metastatic/advanced breast cancer (mBC) is a major public health issue. During the last decades, a therapeutic challenge was to overcome the tumor's resistance to endocrine therapy (ET). Thanks to a better understanding of the molecular mechanisms of this resistance, effective new treatments have been developed, such as Kisqali® (ribociclib), a molecularly targeted therapy. This treatment blocks the growth and division of cancer cells by blocking proteins called CDK4/6 located inside the cell. This treatment, taken in combination with ET, blocks the harmful effect of hormones (estrogen) on cancer cell proliferation, and represent the standard first-line treatment of patients with HR+/HER2- mBC.

But, as with any treatment, it is expected that some patients will have a good response and their disease will be stabilized or even in remission, while other patients will not benefit from treatment and will relapse. In order to make progress, it is necessary to identify pre-therapeutic markers predictive of response to this treatment and the molecular mechanisms of this resistance set up by the tumor before or under the effect of the treatment.

The Trans-RosaLEE study aims to fill this gap by providing high-throughput molecular profiling (DNA and RNA) of a collection of tumor and blood samples from patients with RH+/HER2- mBC scheduled to start treatment with Kisqali® + ET. Samples will be collected just prior to initiation of therapy (pre-therapy) and just after discontinuation of therapy in the event of disease progression (post-therapy).

The main objectives of the TransRosaLEE study are :

to determine if Kisqali® + ET treatment causes changes in the DNA and/or RNA genes of tumor;
to identify whether there is a molecular signature that would predict clinical outcome of patients treated with Kisqali® + ET (tumor response, survival);
to identify alterations in tumor's genes that could be targeted by a specific treatment and that would allow, in case of progression of the disease, to set up a new adapted treatment.

The TransRosaLEE study is a collaborative study between the Paoli-Calmettes Institute (France, Marseille) and the pharmaceutical group Novartis. It will take place in up to 90 healthcare institutions in France, and 241 patients will be enrolled. It is closely linked to the non-interventional study RosaLEE promoted by Novartis.

lead_sponsor: Institut Paoli-Calmettes

intervention_type: Genetic


title: Evaluation of the Safety of Ambulatory Surgery in Senology and Gynecology Within the Paris Saint-Joseph Hospital Group

acronym: AMBUGYN

summary:
Ambulatory surgery is defined as "surgical procedures scheduled and performed under technical conditions that imperatively require the safety of an operating room, under an anesthesia of variable mode and followed by a postoperative monitoring allowing, without increased risk, the discharge of the patient on the same day of his intervention.

It therefore does not include hospital accommodation and represents an alternative to traditional hospitalization.

Ambulatory surgery is of interest in a growing number of situations. Its interest lies on the one hand in the obvious economic interest and in the fact that this model corresponds to the expectations of patients in 2021, allowing them to return to their usual living environment as soon as possible. It also reduces the risk of infections associated with care, due to the short duration of the stay and the minimally invasive surgical techniques, without compromising safety conditions.

It therefore requires a well-designed circuit, ensuring the quality and safety of care at all stages, to allow an early return home without risk.

Since 2011, the French National Authority for Health has defined outpatient surgery as a priority objective in France, setting a target of 70% of surgeries performed as outpatient procedures by 2022.

Currently, less than 50% of surgery in France is performed on an outpatient basis, compared to 65% in Belgium, in Northern European countries and even 85% in the United States.

As early as 2001, the Assurance Maladie identified gynecological surgery as a surgery with a high potential for development in ambulatory care, particularly breast surgery and gynecological laparoscopy.

Many gynecological surgeries benefit from this type of management, in particular because of the low level of patient comorbidity, but the risks of failure are difficult to predict because of the small amount of data available in the literature, particularly in gynecology.

Paris Saint-Joseph Hospital inaugurated the Ambulatory Surgery Unit (ASU) in 2018, with a well-defined patient pathway, and outpatient surgical activity in gynecology represents 15% of activity among the 9 surgical disciplines.

The aim of this study is therefore to evaluate the safety of ambulatory management of patients operated on at the GHPSJ in the ambulatory surgery unit, in the context of breast surgery or gynaecological surgery, by assessing complications and their risk factors.

status: Active, not recruiting

ReferenceCitation: Brédart A, Bottomley A, Blazeby JM, Conroy T, Coens C, D'Haese S, Chie WC, Hammerlid E, Arraras JI, Efficace F, Rodary C, Schraub S, Costantini M, Costantini A, Joly F, Sezer O, Razavi D, Mehlitz M, Bielska-Lasota M, Aaronson NK; European Organisation for Research and Treatment of Cancer Quality of Life Group and Quality of Life Unit. An international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32). Eur J Cancer. 2005 Sep;41(14):2120-31.

ReferenceCitation: Marchal F, Dravet F, Classe JM, Campion L, François T, Labbe D, Robard S, Théard JL, Pioud R. Post-operative care and patient satisfaction after ambulatory surgery for breast cancer patients. Eur J Surg Oncol. 2005 Jun;31(5):495-9.

ReferenceCitation: Hejl L, Raft J, Leufflen L, Rauch P, Buhler J, Abel-Decollogne F, Routiot T, Hotton J, Salleron J, Marchal F. Quality of life, anxiety, and postoperative complications of patients undergoing breast cancer surgery as ambulatory surgery compared to non-ambulatory surgery: A prospective non-randomized study. J Gynecol Obstet Hum Reprod. 2021 Feb;50(2):101779. doi: 10.1016/j.jogoh.2020.101779. Epub 2020 May 11.

ReferenceCitation: Engbaek J, Bartholdy J, Hjortsø NC. Return hospital visits and morbidity within 60 days after day surgery: a retrospective study of 18,736 day surgical procedures. Acta Anaesthesiol Scand. 2006 Sep;50(8):911-9.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Dataids Prospective Observational Cohort on Quality of Care of French HIV Infected Patients

summary:
The objective of the Dataids cohort is to continue a long-term, prospective collection of clinical, laboratory and therapeutic data on a large cohort of HIV infected patients seeking care in 15 HIV centers in France in order :

to provide and develop a surveillance system to describe clinical practice and temporal changes in the clinical course of HIV and HIV-related co-infections and co-morbidities in France.
to assess the factors associated with the clinical, immunological and virological course of HIV infection and HIV-related co-infections and co-morbidities

The specific objectives are as follows

To continue surveillance of HIV infection in France to describe temporal changes
To evaluate the efficacy of ART and factors associated with ART efficacy
To monitor the uptake and outcome of HCV therapy

ReferenceType: result

ReferenceCitation: Pugliese P, Cuzin L, Cabié A, Poizot-Martin I, Allavena C, Duvivier C, El Guedj M, de la Tribonnière X, Valantin MA, Dellamonica P; Nadis Group. A large French prospective cohort of HIV-infected patients: the Nadis Cohort. HIV Med. 2009 Sep;10(8):504-11. doi: 10.1111/j.1468-1293.2009.00719.x. Epub 2009 May 19.

ReferenceCitation: Cuzin L, Allavena C, Cotte L, Delpierre C, Huleux T, Palich R, Delobel P, Raffi F, Cabié A; Dat'AIDS Study Group. No barrier to care, yet disparities in the HIV care continuum in France: a nationwide population study. J Antimicrob Chemother. 2021 May 12;76(6):1573-1579. doi: 10.1093/jac/dkab061.

ReferenceCitation: Cotte L, Hocqueloux L, Lefebvre M, Pradat P, Bani-Sadr F, Huleux T, Poizot-Martin I, Pugliese P, Rey D, Cabié A; Dat'AIDS Study Group. Microelimination or Not? The Changing Epidemiology of Human Immunodeficiency Virus-Hepatitis C Virus Coinfection in France 2012-2018. Clin Infect Dis. 2021 Nov 2;73(9):e3266-e3274. doi: 10.1093/cid/ciaa1940.

ReferenceCitation: Ursenbach A, Max V, Maurel M, Bani-Sadr F, Gagneux-Brunon A, Garraffo R, Ravaux I, Robineau O, Makinson A, Rey D; Dat'AIDS Study Group. Incidence of diabetes in HIV-infected patients treated with first-line integrase strand transfer inhibitors: a French multicentre retrospective study. J Antimicrob Chemother. 2020 Nov 1;75(11):3344-3348. doi: 10.1093/jac/dkaa330.

ReferenceCitation: Le Guillou A, Pugliese P, Raffi F, Cabie A, Cuzin L, Katlama C, Allavena C, Drame M, Cotte L, Bani-Sadr F; Dat'AIDS Study Group. Reaching the Second and Third Joint United Nations Programme on HIV/AIDS 90-90-90 Targets Is Accompanied by a Dramatic Reduction in Primary Human Immunodeficiency Virus (HIV) Infection and in Recent HIV Infections in a Large French Nationwide HIV Cohort. Clin Infect Dis. 2020 Jul 11;71(2):293-300. doi: 10.1093/cid/ciz800.

ReferenceCitation: Gantner P, Cotte L, Allavena C, Bani-Sadr F, Huleux T, Duvivier C, Valantin MA, Jacomet C, Joly V, Chéret A, Pugliese P, Delobel P, Cabié A, Rey D; Dat'AIDS Study Group. Higher rates of HBsAg clearance with tenofovir-containing therapy in HBV/HIV co-infection. PLoS One. 2019 Apr 18;14(4):e0215464. doi: 10.1371/journal.pone.0215464. eCollection 2019.

ReferenceCitation: Hentzien M, Dramé M, Delpierre C, Allavena C, Cabié A, Cuzin L, Rey D, Pugliese P, Hédelin G, Bani-Sadr F; Dat'AIDS Study Group. HIV-related excess mortality and age-related comorbidities in patients with HIV aged ≥60: a relative survival analysis in the French Dat'AIDS cohort. BMJ Open. 2019 Jan 25;9(1):e024841. doi: 10.1136/bmjopen-2018-024841.

ReferenceCitation: Virlogeux V, Zoulim F, Pugliese P, Poizot-Martin I, Valantin MA, Cuzin L, Reynes J, Billaud E, Huleux T, Bani-Sadr F, Rey D, Frésard A, Jacomet C, Duvivier C, Cheret A, Hustache-Mathieu L, Hoen B, Cabié A, Cotte L; Dat'AIDS Study Group. Modeling HIV-HCV coinfection epidemiology in the direct-acting antiviral era: the road to elimination. BMC Med. 2017 Dec 18;15(1):217. doi: 10.1186/s12916-017-0979-1.

lead_sponsor: DatAids

location_country: France Guadeloupe Martinique

location_facility: Hôpital Bichat - Assistance Publique des Hôpitaux de Paris

location_facility: Hôpital Bicêtre - Assistance Publique des Hôpitaux de Paris

location_facility: CHU Clermont-Ferrand - Hôpital Gabriel-Montpied

location_facility: Hôpital Necker-Pasteur - Assistance Publique des Hôpitaux de Paris

location_facility: Hôpital de la Conception - Assistance Publique des Hôpitaux de Marseille

location_facility: Groupe Hospitalier Pitié Salpêtrière - Assistance Publique des Hôpitaux de Paris

location_facility: Hôpital de la Croix-Rousse - Hospices Civils de Lyon

location_facility: Hôpital Sainte Marguerite - Assistance Publique des Hôpitaux de Marseille


title: A Pilot, Prospective Study Assessing the Evolution of Cardiovascular Function and Quality of Life in Patients With Acute Coronary Syndrome, Included in the SCArabée Therapeutic Education Program

acronym: SCArabée

summary:
Coronary artery disease is defined as a disease of the arteries that vascularize the heart, resulting in myocardial ischemia, i.e. insufficient blood supply to the heart muscle. Eventually, it may be responsible for acute coronary syndrome that includes unstable angina (chest pain) and myocardial infarction (necrosis of the heart muscle).

The main cause of this disease is atheroma, and management involves reducing modifiable cardiovascular risk factors (sedentary lifestyle, smoking, obesity, high blood pressure, diabetes, dyslipidemia). Every year, this disease affects more than 120 000 people in France, aging 65 years on average.

In this real public health problem, there is a significant discrepancy between the excellence of the management of the acute incident and the inadequacy of the re-adaptive and educational management of the care suites. In fact, it is noted that hospitalization times are short given the progress of myocardial revascularization, associated with a low intra-hospital mortality rate, 3% but the places in rehabilitation programs ("Soins de Suite et de Réadaptation" or "SSR") are too limited (25% of the patients are included in these programs). Physical rehabilitation has proven effective for decades, with robust evidence of decreased recurrence and mortality (-20%).

At the Groupe Hospitalier Mutualiste of Grenoble, France, patients are offered two courses of treatment in post-myocardial infarction:

A therapeutic education program: SCarabée,
A rehabilitation program (SSR) The therapeutic education program aims to help the patient identify his needs, acquire knowledge, strengthen his resources and finally develop with him a project to improve his quality of life.

SSR offers physical rehabilitation as a treatment for infarction, which improves cardiovascular function, which is assessed by the cardiorespiratory test.

Is the Scarabée therapeutic education program is sufficient to help the patient improve his physical abilities? This study aims to answer this question, by setting up a reinforced monitoring of the evolution of the cardiovascular function of the patients included in the SCArabée program, via cardiorespiratory tests. The results of this first pilot study will potentially lead to a second randomized study comparing therapeutic education associated with Adapted Physical Education versus therapeutic education alone for the improvement of cardiorespiratory functions and the quality of life of these patients.

ReferenceCitation: Puymirat E, Simon T, Cayla G, Cottin Y, Elbaz M, Coste P, Lemesle G, Motreff P, Popovic B, Khalife K, Labèque JN, Perret T, Le Ray C, Orion L, Jouve B, Blanchard D, Peycher P, Silvain J, Steg PG, Goldstein P, Guéret P, Belle L, Aissaoui N, Ferrières J, Schiele F, Danchin N; USIK, USIC 2000, and FAST-MI investigators. Acute Myocardial Infarction: Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015. Circulation. 2017 Nov 14;136(20):1908-1919. doi: 10.1161/CIRCULATIONAHA.117.030798. Epub 2017 Aug 27.

ReferenceCitation: Kotseva K, De Bacquer D, De Backer G, Rydén L, Jennings C, Gyberg V, Abreu A, Aguiar C, Conde AC, Davletov K, Dilic M, Dolzhenko M, Gaita D, Georgiev B, Gotcheva N, Lalic N, Laucevicius A, Lovic D, Mancas S, Miličić D, Oganov R, Pajak A, Pogosova N, Reiner Ž, Vulic D, Wood D, On Behalf Of The Euroaspire Investigators. Lifestyle and risk factor management in people at high risk of cardiovascular disease. A report from the European Society of Cardiology European Action on Secondary and Primary Prevention by Intervention to Reduce Events (EUROASPIRE) IV cross-sectional survey in 14 European regions. Eur J Prev Cardiol. 2016 Dec;23(18):2007-2018. doi: 10.1177/2047487316667784. Epub 2016 Sep 27.

ReferenceCitation: Belle L, Cayla G, Cottin Y, Coste P, Khalife K, Labèque JN, Farah B, Perret T, Goldstein P, Gueugniaud PY, Braun F, Gauthier J, Gilard M, Le Heuzey JY, Naccache N, Drouet E, Bataille V, Ferrières J, Puymirat E, Schiele F, Simon T, Danchin N; FAST-MI 2015 investigators. French Registry on Acute ST-elevation and non-ST-elevation Myocardial Infarction 2015 (FAST-MI 2015). Design and baseline data. Arch Cardiovasc Dis. 2017 Jun - Jul;110(6-7):366-378. doi: 10.1016/j.acvd.2017.05.001. Epub 2017 Jun 21.

ReferenceCitation: Fox KA, Carruthers KF, Dunbar DR, Graham C, Manning JR, De Raedt H, Buysschaert I, Lambrechts D, Van de Werf F. Underestimated and under-recognized: the late consequences of acute coronary syndrome (GRACE UK-Belgian Study). Eur Heart J. 2010 Nov;31(22):2755-64. doi: 10.1093/eurheartj/ehq326. Epub 2010 Aug 30.

ReferenceCitation: Pavy B, Barbet R, Carré F, Champion C, Iliou MC, Jourdain P, Juillière Y, Monpère C, Brion R; Working Group of Exercise Rehabilitation and Sport; Therapeutic Education Commission of the French Society of Cardiology. Therapeutic education in coronary heart disease: position paper from the Working Group of Exercise Rehabilitation and Sport (GERS) and the Therapeutic Education Commission of the French Society of Cardiology. Arch Cardiovasc Dis. 2013 Dec;106(12):680-9. doi: 10.1016/j.acvd.2013.10.002. Epub 2013 Nov 15. Review.

ReferenceCitation: Nocon M, Hiemann T, Müller-Riemenschneider F, Thalau F, Roll S, Willich SN. Association of physical activity with all-cause and cardiovascular mortality: a systematic review and meta-analysis. Eur J Cardiovasc Prev Rehabil. 2008 Jun;15(3):239-46. doi: 10.1097/HJR.0b013e3282f55e09. Review.

ReferenceCitation: Hambrecht R, Walther C, Möbius-Winkler S, Gielen S, Linke A, Conradi K, Erbs S, Kluge R, Kendziorra K, Sabri O, Sick P, Schuler G. Percutaneous coronary angioplasty compared with exercise training in patients with stable coronary artery disease: a randomized trial. Circulation. 2004 Mar 23;109(11):1371-8. Epub 2004 Mar 8.

ReferenceCitation: Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016 Jan 5;(1):CD001800. doi: 10.1002/14651858.CD001800.pub3. Review. Update in: Cochrane Database Syst Rev. 2021 Nov 6;11:CD001800.

ReferenceCitation: Wood DA, Kotseva K, Connolly S, Jennings C, Mead A, Jones J, Holden A, De Bacquer D, Collier T, De Backer G, Faergeman O; EUROACTION Study Group. Nurse-coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial. Lancet. 2008 Jun 14;371(9629):1999-2012. doi: 10.1016/S0140-6736(08)60868-5.

ReferenceCitation: Giannuzzi P, Temporelli PL, Marchioli R, Maggioni AP, Balestroni G, Ceci V, Chieffo C, Gattone M, Griffo R, Schweiger C, Tavazzi L, Urbinati S, Valagussa F, Vanuzzo D; GOSPEL Investigators. Global secondary prevention strategies to limit event recurrence after myocardial infarction: results of the GOSPEL study, a multicenter, randomized controlled trial from the Italian Cardiac Rehabilitation Network. Arch Intern Med. 2008 Nov 10;168(20):2194-204. doi: 10.1001/archinte.168.20.2194.

ReferenceCitation: Wasserman K, Hansen JE, Sue DY, Whipp BJ, Froelicher VF. Principles of Exercise Testing and Interpretation. Journal of Cardiopulmonary Rehabilitation and Prevention. avr 1987;7(4):189.

ReferenceCitation: Pavy B, Iliou MC, Meurin P, Tabet JY, Corone S; Functional Evaluation and Cardiac Rehabilitation Working Group of the French Society of Cardiology. Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation. Arch Intern Med. 2006 Nov 27;166(21):2329-34.

ReferenceCitation: Cerretelli P. Traité de physiologie de l'exercice et du sport. Elsevier Masson; 2002. 504 p.

ReferenceCitation: Wilmore JH, Costill DL, Kenney L. Physiologie du sport et de l'exercice. De Boeck Superieur; 2017. 644 p.

lead_sponsor: Groupe Hospitalier Mutualiste de Grenoble


title: Study of the Impact of Adjuvant Hormone Therapy on Bone and Cardiovascular Risk After Initial Treatment in Patients With Non-metastatic Breast Cancer

acronym: IMPACTTHKS

summary: Breast cancer is the most frequently observed cancer in women in France.The mortality rate is still decreasing with a decrease of 1.6% per year between 2010 and 2018, explained by the improvement in available treatments.For patients with breast cancer expressing hormone receptors, treatment with Tamoxifen or anti-aromatase can have the risk of the cancer coming back.However, these treatments have many side effects, including the risk of osteoporosis and metabolic disorders with anti-aromatases; and arterial and thromboembolic accidents with Tamoxifen.These effects have been well studied while taking hormone therapy.However, very few studies have analyzed the impact of these treatments after stopping them in women who have had non-metastatic hormone-sensitive breast cancer and uncertainties persist on the evolution of the health risk after initial treatment.

lead_sponsor: University Hospital, Toulouse