title: Evaluation of the Impact of the Use of the Digital Solution NewSpringForMe on Transplanted Patients' Quality of Life and Support (Bone Marrow or Peripheral Stem Cells Allotransplantation)

acronym: NSFM

summary:
Bone marrow transplantation is both a great treatment for patients with hematological diseases. It is also one of the only hopes of staying alive by "starting from scratch". It is a trying life experience, at all its stages. To support these patients and increase their success in healing and returning to a "normal life", quality of life is an ally of choice for the success of care.

NewSpringForMe is an innovative tool designed for the benefit of transplant patients, through the deployment of unprecedented interdisciplinary support benefiting from the best digital technologies. This digital solution is aimed at all patients, adults and pediatrics, before, during and after bone marrow transplantation, in a long-term approach. NewSpringForMe results from the multidisciplinary collaboration of medical and paramedical experts in the field of hematology and transplantation, as well as in the field of psychology.

With NewSpringForMe, each transplant patient has a personalized and scalable space accessible via a web platform, constantly offering, according to their needs and at their own pace, a range of recommendations, tools and exercises in psychology, nutrition / dietetics and physical activity, the three pillars of overall well-being. Perfectly integrated into the care pathway and the transplant protocol, from the announcement of the treatment to the long-term follow-up, several years after the intervention, NewSpringForMe complements the medical treatments provided by the medical profession: the communication of the assessments from the platform as well as patient data for caregivers allows adaptation of therapies and optimization of medical care. Thanks to the consideration of individual parameters and their evolution, and thanks to specific algorithms, each tool is adapted to the course of care and to the life of each patient, as well as to their personal health situation throughout their transplant journey.

In order to demonstrate the benefits of using NewSpringForMe, the project plans to evaluate the platform and its impact on the quality of life in patients with hematological diseases. This evaluation will be done by the patients themselves and by the nursing staff. The evaluation will be carried out using a monocentric approach on a pilot cohort. The objective is to demonstrate that integrative health ensuring simultaneous care of body and mind increases the chances of success of the transplant while limiting post-transplant complications.

ReferenceCitation: Dirou S, Chambellan A, Chevallier P, Germaud P, Lamirault G, Gourraud PA, Perrot B, Delasalle B, Forestier B, Guillaume T, Peterlin P, Garnier A, Magnan A, Blanc FX, Lemarchand P. Deconditioning, fatigue and impaired quality of life in long-term survivors after allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2018 Mar;53(3):281-290. doi: 10.1038/s41409-017-0057-5. Epub 2017 Dec 21.

ReferenceCitation: Brotelle T, Lemal R, Cabrespine A, Combal C, Hermet E, Ravinet A, Bay JO, Bouteloup C. Prevalence of malnutrition in adult patients previously treated with allogeneic hematopoietic stem-cell transplantation. Clin Nutr. 2018 Apr;37(2):739-745. doi: 10.1016/j.clnu.2017.03.016. Epub 2017 Mar 28.

ReferenceCitation: Corman M, Rubio MT, Cabrespine A, Brindel I, Bay JO, Peffault De La Tour R, Dambrun M. Mental health and quality of life of patients undergoing hematopoietic stem cell transplantation (HSCT) prior to hospitalization: a cross-sectional complete state health study. Health Psychol Behav Med. 2021 Jan 28;9(1):70-83. doi: 10.1080/21642850.2021.1873140.

ReferenceCitation: Hoodin F, Uberti JP, Lynch TJ, Steele P, Ratanatharathorn V. Do negative or positive emotions differentially impact mortality after adult stem cell transplant? Bone Marrow Transplant. 2006 Aug;38(4):255-64. doi: 10.1038/sj.bmt.1705419. Epub 2006 Jun 19.

ReferenceCitation: Kisch A, Lenhoff S, Zdravkovic S, Bolmsjo I. Factors associated with changes in quality of life in patients undergoing allogeneic haematopoietic stem cell transplantation. Eur J Cancer Care (Engl). 2012 Nov;21(6):735-46. doi: 10.1111/j.1365-2354.2012.01354.x. Epub 2012 Apr 23.

ReferenceCitation: Snowden JA, Sanchez-Ortega I, Corbacioglu S, Basak GW, Chabannon C, de la Camara R, Dolstra H, Duarte RF, Glass B, Greco R, Lankester AC, Mohty M, Neven B, de Latour RP, Pedrazzoli P, Peric Z, Yakoub-Agha I, Sureda A, Kroger N; European Society for Blood and Marrow Transplantation (EBMT). Indications for haematopoietic cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2022. Bone Marrow Transplant. 2022 Aug;57(8):1217-1239. doi: 10.1038/s41409-022-01691-w. Epub 2022 May 19.

ipd_sharing_description: Would depend on the results obtained from the pilot study

lead_sponsor: Fonds de Dotation HTC Project

sponsor_collaborators:
Fonds de Dotation HTC Project
Saint-Louis Hospital, Paris, France
Nutricia Nutrition Clinique
Clinicprosport
ELLYE
Association Aïda
Gilead Sciences
Pfizer
Groupe Apicil
Association Laurette Fugain
Fondation du LEEM
Fondation AFNIC
Pierre Fabre Medicament
Novartis Pharmaceuticals
University Hospital, Clermont-Ferrand
LAPSCO, Université Clermont-Auvergne

location_facility: Service Hématologie Greffe Trèfle 3, Hôpital Saint-Louis, AP-HP


study_start_date_type: Actual

acronym: RECORDS

intervention_type: Drug

lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary:
Main objective and primary endpoint: To compare the effect hydrocortisone plus fludrocortisone vs. placebo on a composite of death or persistent organ dysfunction - defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors - assessed at 90 days on intensive care unit (ICU) adults and having different biological profiles for immune responses and corticosteroids bioactivity.

Secondary objectives and endpoints:

Mortality and health-related quality of life at 6 months;
Daily organ function (SOFA score days 1, 2, 3, 4, 7, 10, 14, 28, and 90);
Daily secondary infections (up to 90 days)
Daily blood and urinary levels of glucose, sodium and potassium (up to 28 day)
Daily gastroduodenal bleeding (up to 28 day)
Daily cognitive function and muscles' strength (days 1 to 28, 90 and 180 days).

ReferenceType: background

ReferenceCitation: Annane D, Pastores SM, Rochwerg B, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Umberto Meduri G, Olsen KM, Rodgers S, Russell JA, Van den Berghe G. Guidelines for the diagnosis and management of critical illness-related corticosteroid insufficiency (CIRCI) in critically ill patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Intensive Care Med. 2017 Dec;43(12):1751-1763. doi: 10.1007/s00134-017-4919-5. Epub 2017 Sep 21. Erratum In: Intensive Care Med. 2018 Feb 23;:

ReferenceCitation: Lamontagne F, Rochwerg B, Lytvyn L, Guyatt GH, Moller MH, Annane D, Kho ME, Adhikari NKJ, Machado F, Vandvik PO, Dodek P, Leboeuf R, Briel M, Hashmi M, Camsooksai J, Shankar-Hari M, Baraki MK, Fugate K, Chua S, Marti C, Cohen D, Botton E, Agoritsas T, Siemieniuk RAC. Corticosteroid therapy for sepsis: a clinical practice guideline. BMJ. 2018 Aug 10;362:k3284. doi: 10.1136/bmj.k3284. No abstract available.

ReferenceCitation: Rochwerg B, Oczkowski SJ, Siemieniuk RAC, Agoritsas T, Belley-Cote E, D'Aragon F, Duan E, English S, Gossack-Keenan K, Alghuroba M, Szczeklik W, Menon K, Alhazzani W, Sevransky J, Vandvik PO, Annane D, Guyatt G. Corticosteroids in Sepsis: An Updated Systematic Review and Meta-Analysis. Crit Care Med. 2018 Sep;46(9):1411-1420. doi: 10.1097/CCM.0000000000003262.

ReferenceCitation: Nishida O, Ogura H, Egi M, Fujishima S, Hayashi Y, Iba T, Imaizumi H, Inoue S, Kakihana Y, Kotani J, Kushimoto S, Masuda Y, Matsuda N, Matsushima A, Nakada TA, Nakagawa S, Nunomiya S, Sadahiro T, Shime N, Yatabe T, Hara Y, Hayashida K, Kondo Y, Sumi Y, Yasuda H, Aoyama K, Azuhata T, Doi K, Doi M, Fujimura N, Fuke R, Fukuda T, Goto K, Hasegawa R, Hashimoto S, Hatakeyama J, Hayakawa M, Hifumi T, Higashibeppu N, Hirai K, Hirose T, Ide K, Kaizuka Y, Kan'o T, Kawasaki T, Kuroda H, Matsuda A, Matsumoto S, Nagae M, Onodera M, Ohnuma T, Oshima K, Saito N, Sakamoto S, Sakuraya M, Sasano M, Sato N, Sawamura A, Shimizu K, Shirai K, Takei T, Takeuchi M, Takimoto K, Taniguchi T, Tatsumi H, Tsuruta R, Yama N, Yamakawa K, Yamashita C, Yamashita K, Yoshida T, Tanaka H, Oda S. The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J-SSCG 2016). Acute Med Surg. 2018 Feb 5;5(1):3-89. doi: 10.1002/ams2.322. eCollection 2018 Jan.

ReferenceCitation: Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

ReferenceCitation: Tavare A, O'Flynn N. Recognition, diagnosis, and early management of sepsis: NICE guideline. Br J Gen Pract. 2017 Apr;67(657):185-186. doi: 10.3399/bjgp17X690401. No abstract available.

ReferenceCitation: van der Poll T, van de Veerdonk FL, Scicluna BP, Netea MG. The immunopathology of sepsis and potential therapeutic targets. Nat Rev Immunol. 2017 Jul;17(7):407-420. doi: 10.1038/nri.2017.36. Epub 2017 Apr 24.

ReferenceCitation: Wong HR, Cvijanovich NZ, Anas N, Allen GL, Thomas NJ, Bigham MT, Weiss SL, Fitzgerald J, Checchia PA, Meyer K, Shanley TP, Quasney M, Hall M, Gedeit R, Freishtat RJ, Nowak J, Shekhar RS, Gertz S, Dawson E, Howard K, Harmon K, Beckman E, Frank E, Lindsell CJ. Developing a clinically feasible personalized medicine approach to pediatric septic shock. Am J Respir Crit Care Med. 2015 Feb 1;191(3):309-15. doi: 10.1164/rccm.201410-1864OC.

ReferenceCitation: Antcliffe DB, Burnham KL, Al-Beidh F, Santhakumaran S, Brett SJ, Hinds CJ, Ashby D, Knight JC, Gordon AC. Transcriptomic Signatures in Sepsis and a Differential Response to Steroids. From the VANISH Randomized Trial. Am J Respir Crit Care Med. 2019 Apr 15;199(8):980-986. doi: 10.1164/rccm.201807-1419OC. Erratum In: Am J Respir Crit Care Med. 2022 Dec 15;206(12):1572-1573.

ReferenceCitation: Annane D, Pastores SM, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Meduri GU, Olsen KM, Rochwerg B, Rodgers SC, Russell JA, Van den Berghe G. Critical illness-related corticosteroid insufficiency (CIRCI): a narrative review from a Multispecialty Task Force of the Society of Critical Care Medicine (SCCM) and the European Society of Intensive Care Medicine (ESICM). Intensive Care Med. 2017 Dec;43(12):1781-1792. doi: 10.1007/s00134-017-4914-x. Epub 2017 Sep 21.

ReferenceCitation: Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

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

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

repository_institution: King's College London - Research Portal

version: submittedVersion

repositories:
PubMed Central
UCL Discovery
kclpure.kcl.ac.uk

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

ReferenceCitation: ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

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

location_facility: Department of medical and surgical Intensive Care Unit, Raymond Poincaré Hospital - APHP

status: Recruiting

title: A Multicentre Concealed-Allocation Multi-arms Blinded Randomized Controlled Trial to Identify the Best Sepsis Population for Corticotherapy

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Anticipated

design_allocation: Randomized

study_completion_date_type: Anticipated

study_type: Interventional

ipd_sharing: No

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: Multi-center Prospective European Cohort Study in Patients With Rheumatoid Arthritis or Juvenile Idiopathic Arthritis Planned to be Treated Independently of the Present Study, With the First Line of Adalimumab, Etanercept, Infliximab Therapy or With Rituximab or Tocilizumab (After Anti-Tumor Necrosis Factor Therapy or Another Biotherapy or in First Line)

acronym: ABI-RA

summary: One of the main potential causes of these failures of BP therapy response is the development of Anti-drug Anti-body (ADAb) in some patients. ADAb may decrease the efficacy of BPs by neutralizing them or modifying their clearance and they may be associated with BP-specific hypersensitivity reactions. The prediction, prevention and cure of anti-drug (AD) immunization are thus major goals in BP development. This prospective study (ABI-RA) will assess the occurrence of ADAb using standardized and validated assay(s) and also cellular, genetic and molecular parameters in RA/JIA patients treated with adalimumab, etanercept, infliximab and rituximab or tocilizumab, to address the mechanism of immunogenicity. Patient-related factors that might predispose an individual to an immune response will be taken into account: underlying disease, genetic background, immune status, including immunomodulating therapy and dosing schedule.

status: Unknown status

primary_purpose: Health Services Research

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Paoletti A, Ly B, Bitoun S, Nocturne G, Riviere E, Manson JJ, Matucci A, Pallardy M, De Vries N, Mariette X. Restoration of Default Blood Monocyte-Derived Macrophage Polarization With Adalimumab But Not Etanercept in Rheumatoid Arthritis. Front Immunol. 2022 Feb 23;13:832117. doi: 10.3389/fimmu.2022.832117. eCollection 2022.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

ReferenceCitation: Duhaze J, Caubet M, Hassler S, Bachelet D, Allez M, Deisenhammer F, Fogdell-Hahn A, Gleizes A, Hacein-Bey-Abina S, Mariette X, Pallardy M, Broet P; ABIRISK Consortium. Assessing the effect of genetic markers on drug immunogenicity from a mechanistic model-based approach. BMC Med Res Methodol. 2020 Mar 20;20(1):69. doi: 10.1186/s12874-020-00941-z.

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: Springer-Nature

ReferenceCitation: Bitoun S, Nocturne G, Ly B, Krzysiek R, Roques P, Pruvost A, Paoletti A, Pascaud J, Donnes P, Florence K, Gleizes A, Hincelin-Mery A, Allez M, Hacein-Bey-Abina S, Mackay F, Pallardy M, Le Grand R, Mariette X. Methotrexate and BAFF interaction prevents immunization against TNF inhibitors. Ann Rheum Dis. 2018 Oct;77(10):1463-1470. doi: 10.1136/annrheumdis-2018-213403. Epub 2018 Jun 23. Erratum In: Ann Rheum Dis. 2021 May;80(5):e84.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: British Medical Journal

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

collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

collaborators: University College London (UCL) Cancer Institute

collaborators: Pediatric Rheumatology International Trials Organization

intervention_type: Procedure

status_simplified: Unknown


title: Investigating Minimal Residual Disease in Autopreserved Ovarian Tissue in Cases of Neoplastic Pathology

acronym: OVAGRAFT

summary: Cryopreservation of ovarian tissue is offered to young girls and women aged under 35 who have to undergo sterilizing gonadotoxic treatment, with the aim of preserving their fertility. The main part of the ovary is preserved, as primordial and primary follicles are resistant to freezing / thawing protocols. In the absence of other techniques (in vivo maturation, injecting isolated ovarian follicles, etc.) autografting this cryopreserved tissue is currently the only technique allowing fertility to be restored. Autograft is possible only if the indication for ovary cryopreservation is a non-neoplastic pathology or a malignant pathology with a low risk of ovarian metastasis. In other cases of neoplastic pathologies, particularly in cases of acute leukemia, tissue cannot as yet be re-used due to the lack of any codified technique for evaluating residual disease (MRD). The team has for two years been developing and validating a technique to look for residual disease in fragments of ovarian cortex in cases of acute leukemia. This technique is based on an original protocol for dissociating ovarian tissue to obtain a population of isolated ovarian cells that may be analyzed by multicolor flow cytometry. The specificity and sensitivity of the technique have been demonstrated in an experimental model. This model consists in using 8 color flow cytometry to look for characterizable leukemia cells added in different dilutions to a population of isolated ovarian cells taken from model ovarian cortex and up to a dilution of 10-5. When the molecular markers were present on diagnosis, they were found by RQ-PCR (Real-Time Quantitative Polymerase Chain Reaction) with the same dilutions. The model tissue came from laparoscopic ovarian drilling in patients with polycystic ovary syndrome. The main objective of this project is to validate techniques that have been previously codified with different populations of leukemia cells that may be characterized. We then aim to adapt and validate this technique to look for MRD using 8 color flow cytometry on cryopreserved fragments of ovarian cortex from leukemia patients that are at risk of metastasis. Secondary objectives will be to implement procedures for oncological qualification of grafts in cases of malignant pathology and to consider the recommendations for using this cryopreserved ovarian tissue through the autograft technique for these indications.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Other

ReferenceCitation: Roux C, Amiot C, Agnani G, Aubard Y, Rohrlich PS, Piver P. Live birth after ovarian tissue autograft in a patient with sickle cell disease treated by allogeneic bone marrow transplantation. Fertil Steril. 2010 May 1;93(7):2413.e15-9. doi: 10.1016/j.fertnstert.2009.12.022. Epub 2010 Feb 1.

ReferenceCitation: Amiot C, Angelot-Delettre F, Zver T, Alvergnas-Vieille M, Saas P, Garnache-Ottou F, Roux C. Minimal residual disease detection of leukemic cells in ovarian cortex by eight-color flow cytometry. Hum Reprod. 2013 Aug;28(8):2157-67. doi: 10.1093/humrep/det126. Epub 2013 Apr 30.

ReferenceCitation: Fauque P, Ben Amor A, Joanne C, Agnani G, Bresson JL, Roux C. Use of trypan blue staining to assess the quality of ovarian cryopreservation. Fertil Steril. 2007 May;87(5):1200-7. doi: 10.1016/j.fertnstert.2006.08.115. Epub 2007 Feb 20.

ReferenceCitation: Zver T, Alvergnas-Vieille M, Garnache-Ottou F, Roux C, Amiot C. A new method for evaluating the risk of transferring leukemic cells with transplanted cryopreserved ovarian tissue. J Assist Reprod Genet. 2015 Aug;32(8):1263-6. doi: 10.1007/s10815-015-0512-4. Epub 2015 Jul 3.

ReferenceCitation: Zver T, Alvergnas-Vieille M, Garnache-Ottou F, Ferrand C, Roux C, Amiot C. Minimal residual disease detection in cryopreserved ovarian tissue by multicolor flow cytometry in acute myeloid leukemia. Haematologica. 2014 Dec;99(12):e249-52. doi: 10.3324/haematol.2014.113373. Epub 2014 Sep 19. No abstract available.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

collaborators:
CHU de Reims
University Hospital, Marseille
University Hospital, Lille
Central Hospital, Nancy, France
University Hospital, Grenoble
CMCO SIHCUS, Schiltingheim
University Hospital, Bordeaux
University Hospital, Limoges
Nantes University Hospital
University Hospital, Toulouse
University Hospital, Rouen

status_simplified: Completed


title: Cognitive, Morphological and Neurobiological Progressive Aspects in Bipolar Disorders in the Elderly: Toward to a Neurodegenerescence Detection?

acronym: BIPAGE

summary: The purpose of this study is to identify association between cerebrospinal fluid Alzheimer's Disease's neurodegenerescence biomarkers (tau, ptau, Aß40 and Aß1-42) and occurrence of cognitive deficits in older patients with bipolar disorders.

design_allocation: Non-Randomized

primary_purpose: Screening

ReferenceCitation: Ali SO, Denicoff KD, Altshuler LL, Hauser P, Li X, Conrad AJ, Smith-Jackson EE, Leverich GS, Post RM. Relationship between prior course of illness and neuroanatomic structures in bipolar disorder: a preliminary study. Neuropsychiatry Neuropsychol Behav Neurol. 2001 Oct-Dec;14(4):227-32.

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ReferenceCitation: Bora E, Vahip S, Gonul AS, Akdeniz F, Alkan M, Ogut M, Eryavuz A. Evidence for theory of mind deficits in euthymic patients with bipolar disorder. Acta Psychiatr Scand. 2005 Aug;112(2):110-6. doi: 10.1111/j.1600-0447.2005.00570.x.

ReferenceCitation: Chetelat G, Eustache F, Viader F, De La Sayette V, Pelerin A, Mezenge F, Hannequin D, Dupuy B, Baron JC, Desgranges B. FDG-PET measurement is more accurate than neuropsychological assessments to predict global cognitive deterioration in patients with mild cognitive impairment. Neurocase. 2005 Feb;11(1):14-25. doi: 10.1080/13554790490896938.

ReferenceCitation: Chetelat G, Desgranges B, Eustache F. [Brain profile of hypometabolism in early Alzheimer's disease: relationships with cognitive deficits and atrophy]. Rev Neurol (Paris). 2006 Oct;162(10):945-51. doi: 10.1016/s0035-3787(06)75104-9. French.

ReferenceCitation: Corder EH, Saunders AM, Strittmatter WJ, Schmechel DE, Gaskell PC, Small GW, Roses AD, Haines JL, Pericak-Vance MA. Gene dose of apolipoprotein E type 4 allele and the risk of Alzheimer's disease in late onset families. Science. 1993 Aug 13;261(5123):921-3. doi: 10.1126/science.8346443.

ReferenceCitation: Delaloye C, Moy G, Baudois S, de Bilbao F, Remund CD, Hofer F, Ragno Paquier C, Campos L, Weber K, Gold G, Moussa A, Meiler CC, Giannakopoulos P. Cognitive features in euthymic bipolar patients in old age. Bipolar Disord. 2009 Nov;11(7):735-43. doi: 10.1111/j.1399-5618.2009.00741.x. Epub 2009 Aug 28.

ReferenceCitation: Delaloye C, Moy G, de Bilbao F, Weber K, Baudois S, Haller S, Xekardaki A, Canuto A, Giardini U, Lovblad KO, Gold G, Giannakopoulos P. Longitudinal analysis of cognitive performances and structural brain changes in late-life bipolar disorder. Int J Geriatr Psychiatry. 2011 Dec;26(12):1309-18. doi: 10.1002/gps.2683. Epub 2011 Mar 10.

ReferenceCitation: Doring TM, Kubo TT, Cruz LC Jr, Juruena MF, Fainberg J, Domingues RC, Gasparetto EL. Evaluation of hippocampal volume based on MR imaging in patients with bipolar affective disorder applying manual and automatic segmentation techniques. J Magn Reson Imaging. 2011 Mar;33(3):565-72. doi: 10.1002/jmri.22473.

ReferenceCitation: Ewers M, Buerger K, Teipel SJ, Scheltens P, Schroder J, Zinkowski RP, Bouwman FH, Schonknecht P, Schoonenboom NS, Andreasen N, Wallin A, DeBernardis JF, Kerkman DJ, Heindl B, Blennow K, Hampel H. Multicenter assessment of CSF-phosphorylated tau for the prediction of conversion of MCI. Neurology. 2007 Dec 11;69(24):2205-12. doi: 10.1212/01.wnl.0000286944.22262.ff.

ReferenceCitation: Fagan AM, Mintun MA, Shah AR, Aldea P, Roe CM, Mach RH, Marcus D, Morris JC, Holtzman DM. Cerebrospinal fluid tau and ptau(181) increase with cortical amyloid deposition in cognitively normal individuals: implications for future clinical trials of Alzheimer's disease. EMBO Mol Med. 2009 Nov;1(8-9):371-80. doi: 10.1002/emmm.200900048.

ReferenceCitation: Hindley NJ, Jobst KA, King E, Barnetson L, Smith A, Haigh AM. High acceptability and low morbidity of diagnostic lumbar puncture in elderly subjects of mixed cognitive status. Acta Neurol Scand. 1995 May;91(5):405-11. doi: 10.1111/j.1600-0404.1995.tb07029.x.

ReferenceCitation: Jones LD, Payne ME, Messer DF, Beyer JL, MacFall JR, Krishnan KR, Taylor WD. Temporal lobe volume in bipolar disorder: relationship with diagnosis and antipsychotic medication use. J Affect Disord. 2009 Apr;114(1-3):50-7. doi: 10.1016/j.jad.2008.07.003. Epub 2008 Aug 8.

ReferenceCitation: Kessing LV, Nilsson FM. Increased risk of developing dementia in patients with major affective disorders compared to patients with other medical illnesses. J Affect Disord. 2003 Feb;73(3):261-9. doi: 10.1016/s0165-0327(02)00004-6.

ReferenceCitation: Kessing LV, Andersen PK. Does the risk of developing dementia increase with the number of episodes in patients with depressive disorder and in patients with bipolar disorder? J Neurol Neurosurg Psychiatry. 2004 Dec;75(12):1662-6. doi: 10.1136/jnnp.2003.031773.

ReferenceCitation: Li G, Sokal I, Quinn JF, Leverenz JB, Brodey M, Schellenberg GD, Kaye JA, Raskind MA, Zhang J, Peskind ER, Montine TJ. CSF tau/Abeta42 ratio for increased risk of mild cognitive impairment: a follow-up study. Neurology. 2007 Aug 14;69(7):631-9. doi: 10.1212/01.wnl.0000267428.62582.aa.

ReferenceCitation: Masouy A, Chopard G, Vandel P, Magnin E, Rumbach L, Sechter D, Haffen E. Bipolar disorder and dementia: where is the link? Psychogeriatrics. 2011 Mar;11(1):60-7. doi: 10.1111/j.1479-8301.2010.00348.x.

ReferenceCitation: Martino DJ, Igoa A, Marengo E, Scapola M, Ais ED, Strejilevich SA. Cognitive and motor features in elderly people with bipolar disorder. J Affect Disord. 2008 Jan;105(1-3):291-5. doi: 10.1016/j.jad.2007.05.014. Epub 2007 Jun 18.

ReferenceCitation: Meeks S. Bipolar disorder in the latter half of life: symptom presentation, global functioning and age of onset. J Affect Disord. 1999 Jan-Mar;52(1-3):161-7. doi: 10.1016/s0165-0327(98)00069-x.

ReferenceCitation: Peskind E, Nordberg A, Darreh-Shori T, Soininen H. Safety of lumbar puncture procedures in patients with Alzheimer's disease. Curr Alzheimer Res. 2009 Jun;6(3):290-2. doi: 10.2174/156720509788486509.

ReferenceCitation: Peskind ER, Riekse R, Quinn JF, Kaye J, Clark CM, Farlow MR, Decarli C, Chabal C, Vavrek D, Raskind MA, Galasko D. Safety and acceptability of the research lumbar puncture. Alzheimer Dis Assoc Disord. 2005 Oct-Dec;19(4):220-5. doi: 10.1097/01.wad.0000194014.43575.fd.

ReferenceCitation: Preuss UW, Watzke S, Choi JH. Diagnostic correlates of Alzheimer dementia in a U.S. Nationwide inpatient sample. Am J Geriatr Psychiatry. 2010 Sep;18(9):821-9. doi: 10.1097/JGP.0b013e3181ca3a13.

ReferenceCitation: Saunders AM, Strittmatter WJ, Schmechel D, George-Hyslop PH, Pericak-Vance MA, Joo SH, Rosi BL, Gusella JF, Crapper-MacLachlan DR, Alberts MJ, et al. Association of apolipoprotein E allele epsilon 4 with late-onset familial and sporadic Alzheimer's disease. Neurology. 1993 Aug;43(8):1467-72. doi: 10.1212/wnl.43.8.1467.

ReferenceCitation: Tapiola T, Alafuzoff I, Herukka SK, Parkkinen L, Hartikainen P, Soininen H, Pirttila T. Cerebrospinal fluid beta-amyloid 42 and tau proteins as biomarkers of Alzheimer-type pathologic changes in the brain. Arch Neurol. 2009 Mar;66(3):382-9. doi: 10.1001/archneurol.2008.596.

ReferenceCitation: Thomann PA, Kaiser E, Schonknecht P, Pantel J, Essig M, Schroder J. Association of total tau and phosphorylated tau 181 protein levels in cerebrospinal fluid with cerebral atrophy in mild cognitive impairment and Alzheimer disease. J Psychiatry Neurosci. 2009 Mar;34(2):136-42.

ReferenceCitation: Vemuri P, Wiste HJ, Weigand SD, Knopman DS, Trojanowski JQ, Shaw LM, Bernstein MA, Aisen PS, Weiner M, Petersen RC, Jack CR Jr; Alzheimer's Disease Neuroimaging Initiative. Serial MRI and CSF biomarkers in normal aging, MCI, and AD. Neurology. 2010 Jul 13;75(2):143-51. doi: 10.1212/WNL.0b013e3181e7ca82.

ReferenceCitation: Verghese PB, Castellano JM, Holtzman DM. Apolipoprotein E in Alzheimer's disease and other neurological disorders. Lancet Neurol. 2011 Mar;10(3):241-52. doi: 10.1016/S1474-4422(10)70325-2.

ReferenceCitation: Wingo AP, Harvey PD, Baldessarini RJ. Neurocognitive impairment in bipolar disorder patients: functional implications. Bipolar Disord. 2009 Mar;11(2):113-25. doi: 10.1111/j.1399-5618.2009.00665.x.

ReferenceCitation: Zetterberg H, Tullhog K, Hansson O, Minthon L, Londos E, Blennow K. Low incidence of post-lumbar puncture headache in 1,089 consecutive memory clinic patients. Eur Neurol. 2010;63(6):326-30. doi: 10.1159/000311703. Epub 2010 Jun 3.

lead_sponsor: University Hospital, Grenoble

collaborators: Centre Hospitalier Universitaire de Besancon


title: Impact of Body Mass Index on the Agreement Between Ultrasound- and Clinical Assessments of Disease Activity in RA : Cross-sectionnal Study

acronym: RABODI

summary: Comparison of the level of agreement between Power Doppler ultrasound measured number of synovitis (≥ grade 1 on a semi-quantitative scale) and clinically defined number of swollen joints in obese (i.e. BMI>30) versus normally weighted RA patients.

time_perspective: Prospective

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
Pitié-Salpêtrière Hospital
Hospital Ambroise Paré Paris
Nantes University Hospital
Rennes University Hospital
University Hospital, Grenoble
CHU Brest Hôpital La Cavale Blanche
Hospital Purpan
Centre Hospitalier Lyon Sud
Central Hospital, Nancy, France
Centre Hospitalier de la côte Basque

intervention_type: Other


title: Looking For Genetic and Environmental Risk Factors and Therapeutic Aspects in Cervical Artery Dissections

acronym: CADISP

summary: The main purpose of this study is to look for genetic and environmental risk factors of cervical artery dissections, a major cause of ischemic stroke in young adults, in a large multicenter case-control trial

ReferenceCitation: Engelter ST, Brandt T, Debette S, Caso V, Lichy C, Pezzini A, Abboud S, Bersano A, Dittrich R, Grond-Ginsbach C, Hausser I, Kloss M, Grau AJ, Tatlisumak T, Leys D, Lyrer PA; Cervical Artery Dissection in Ischemic Stroke Patients (CADISP) Study Group. Antiplatelets versus anticoagulation in cervical artery dissection. Stroke. 2007 Sep;38(9):2605-11. doi: 10.1161/STROKEAHA.107.489666. Epub 2007 Jul 26.

ReferenceCitation: Debette S, Metso TM, Pezzini A, Engelter ST, Leys D, Lyrer P, Metso AJ, Brandt T, Kloss M, Lichy C, Hausser I, Touze E, Markus HS, Abboud S, Caso V, Bersano A, Grau A, Altintas A, Amouyel P, Tatlisumak T, Dallongeville J, Grond-Ginsbach C; CADISP-group. CADISP-genetics: an International project searching for genetic risk factors of cervical artery dissections. Int J Stroke. 2009 Jun;4(3):224-30. doi: 10.1111/j.1747-4949.2009.00281.x.

lead_sponsor: Cervical Artery Dissections and Ischemic Stroke Patients - Consortium

location_country:
Germany
Finland
Italy
United Kingdom
Argentina
Switzerland
Belgium
Turkey
France

location_facility: Department of Neurology, Ospedale Maggiore Policlinico di Milano

location_facility: Department of Neurology, University Hospital of Leuven

location_facility: Department of Neurology, University Hospital of Perugia

location_facility: Department of Neurology, University Hospital of Besançon

location_facility: Department of Neurology, University Hospital Sainte-Anne

location_facility: Department of Neurology, University Hospital of Amiens

location_facility: Department of Neurology, University Hospital Pitié-Salpêtrière

location_facility: Department of Neurology, University Hospital of Basel

location_facility: Department of Neurology, Hospital of Ludwigshafen

location_facility: Department of Neurology, University Hospital of Munich

location_facility: Department of Neurology, University Hospital of Lille

location_facility: Department of Neurology, University Hospital of Brescia

location_facility: Department of Neurology, University Hospital Milano-Bicocca

location_facility: Department of Neurology, University Hospital of Brussels (ULB)

location_facility: Department of Neurology, Cerrahpasa Medical Faculty, Istanbul University

location_facility: Department of Neurology, University Hospital of Dijon

location_facility: Department of Neurology, Helsinki University Central Hospital

location_facility: Department of Neuroscience, St George's University Hospital of London

location_facility: Rehabilitation Center, IRCCS Santa Lucia, Roma

location_facility: Department of Neurology, University Hospital of Heidelberg

lead_sponsor_type: industriel


title: Cost-utility Analysis of the Follow-up of Exclusive Telemedicine Pacemakers, Compared to Conventional Pacemakers

acronym: TELEPACE

summary: TELEPACE is an economic evaluation that aims to determine the probability at which Home Monitoring without physical examinations, could be cost effective, compared to the conventional treatment by face to face consultations. Patient will be randomized in a control group followed according to the current guidelines and and active group exclusively followed by remote monitoring. The study will end after a 4 year follow-up.

status: Active, not recruiting

primary_purpose: Other

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
Tours University Hospital
University Hospital, Marseille
Rennes University Hospital
Toulouse University Hospital
University Hospital, Clermont-Ferrand
Angers University Hospital
Lille University Hospital
University Hospital, Strasbourg, France
Rouen University Hospital
Montpellier University Hospital
University Hospital, Brest
Pau University Hospital


title: Prevention of New Onset Diabetes After Transplantation by a Short Term Treatment of Vildagliptin in the Early Post-transplant Period

acronym: PRODIG

summary:
Post-transplant diabetes affects 15 to 20% of renal transplant patients and contributes to increased morbidity and reduced survival of transplants and patients. Corticosteroids, anti-calcineurin and mammilian Target OF Rapamycin (mTOR) inhibitors have a major diabetogenic impact and greatly contribute to the increase in diabetes prevalence after transplantation.

There are to date few studies concerning the pharmacological prevention of post-transplant diabetes. Hecking et al. have recently reported that a short treatment with insulin, administered immediately after transplantation, reduce the incidence of de novo diabetes one-year post-transplant. This study included 50 renal transplant patients and showed that a three months treatment of (Neutral Protamine Hagedorn) NPH insulin decreased HbA1c. The occurrence of diabetes, a secondary end-point, was reduced by 73% in the treated group.

No further pharmacological strategy has been developed to date. Relevant experimental evidences suggest that gliptins could be used in the pharmacological prevention of post-transplant diabetes. These drugs are inhibitors of dipeptidyl peptidase-4 (DPP-4), which inactivates the incretins, the glucagon-like peptide-1 (GLP-1) and the gastric inhibitory polypeptide (GIP). DPP-4 inhibition causes an increase in the GLP-1 and GIP concentrations which induce insulin secretion and inhibition of glucagon secretion. The gliptins are approved for the treatment of type 2 diabetes. Beyond the effects on blood glucose, gliptins have pleiotropic effects including a protective effect on β cells and anti-inflammatory effect.

The additional cost associated with new-onset diabetes after transplantation could be also significantly reduced by efficient prevention. A US study found that, for the period between 1994 and 1998, a newly diagnosed diabetic patient has cost $21,500 of medical expenses 2 years after transplantation. Moreover, transplantation resulting in one of the best increases of patients' quality of life, its estimate is essential in the treatment evaluation of this population.

primary_purpose: Prevention

ReferenceCitation: Gaiffe E, Crepin T, Bamoulid J, Courivaud C, Buchler M, Cassuto E, Albano L, Chemouny JM, Choukroun G, Hazzan M, Kessler L, Legendre C, Le Meur Y, Ouali N, Thierry A, Anota A, Nerich V, Limat S, Bonnetain F, Vernerey D, Ducloux D. PRODIG (Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early renal post-transplant period) study: study protocol for a randomized controlled study. Trials. 2019 Jun 21;20(1):375. doi: 10.1186/s13063-019-3392-6.

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

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

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

repository_institution: Research Square - Research Square

repository_normalized: Research Square

repositories:
HAL
PubMed Central
Research Square
univOAK

collaborators: Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

collaborators: Centre Hospitalier Universitaire de Nice

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon

appel_a_projets: PHRCN

region: Bourgogne-Franche-Comté

nom_etablissement: CHU BESANCON

type_etablissement: CH

acronyme: Prodig

titre: Prévention du diabète post-transplantation par la Vidagliptine chez les patients greffés rénaux

discipline_principale: néphrologie

nom_porteur: DUCLOUX

prenom_porteur: Didier


title: PERCING : Ovarian Drilling Versus Ovarian Stimulation + Intra Uterine Insemination (IUI) + Metformin in the PCOS (PolyCystic Ovaries Syndrome) Treatment

acronym: PERCING

summary:
PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination (IUI) which lead to 50% pregnancies each. However, surgical treatment could be associated to surgical complications, and medical treatment could be associated to ovarian hyperstimulation syndrome and/or multiple pregnancies.

The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments. After an ambulatory surgery we will observe the spontaneous fertility during 9 months. For the medical treatment, Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal

ReferenceCitation: Fernandez H, Watrelot A, Alby JD, Kadoch J, Gervaise A, deTayrac R, Frydman R. Fertility after ovarian drilling by transvaginal fertiloscopy for treatment of polycystic ovary syndrome. J Am Assoc Gynecol Laparosc. 2004 Aug;11(3):374-8. doi: 10.1016/s1074-3804(05)60054-0.

collaborators: Centre Hospitalier Universitaire, Amiens

collaborators: Lille Hospital : Jeanne de Flandre Hospital

collaborators: Study and research center of sterility (Lyon)


title: French National Cohort of People With Type 1 Diabètes: the SFDT1 Study

summary:
Cardiovascular (CV) diseases are the most frequent type 1 diabetes (T1D) complications. A recent epidemiological study showed that patients with T1D have a two-fold CV mortality risk, even in case of good glycemic control. In addition, it has been shown that patients with T1D with no traditional CV risk factors had about a 80% higher risk of cardiovascular event compared to non-diabetic individuals. This indicates that further modifiable risk factors in relation to CV mortality remain to be identified.

One of the candidates that could help to disentangle the factors associated with the increased CV mortality in T1D patients is glycemic variability which could contribute to diabetes complications. Indeed, severe hypoglycaemia, one of the most severe consequence of glycaemic variability, are associated with a higher mortality in patients with type 1 and type 2 diabetes.

In order to evaluate the relation between glycemic variability, insulin therapy modalities and CV risk as well as some other questions related to health determinants of T1D, we are building up a large observational, prospective, multi-centric cohort study of patients gathering 15,000 patients with T1D, age above 6 years old, to perform the following:

Collecting clinical information
Evaluating Glycemic variability (assessed by the coefficient of variation of glucose (CV) calculated from automatically downloaded continuous glucose monitoring data (CGM)
Biobanking including plasma, DNA, urine, saliva and hair.
Collecting patients' reported outcomes through auto-questionnaires (online questionnaires).
Doing an active follow-up for a period of 10 years with an intermediate visit every 3 years.
Passive follow-up: link to national Health data system (Système National de Données de Santé, SNDS) in order to exhaustively collect health events as death, CV events and hospitalizations (including severe hypoglycemia).

ipd_sharing: Undecided

lead_sponsor: Fondation Francophone pour la Recherche sur le Diabete


title: Management of Prenatally Diagnosed Isolated Right Aortic Arch: the ARCADE Study

acronym: ARCADE

summary:
The existence of a right aortic arch integrates nosologically into the group of aortic vascular arch anomalies. In the majority of cases, a right aortic arch is associated with cono-truncal congenital heart diseases (CHD), such as tetralogy of Fallot, pulmonary atresia with ventricular septal defect, and truncus arteriosus. Sometimes, a right aortic arch can be isolated, with an incidence of 0.05% to 0.1 %. Therefore, an assessment of the anatomy is necessary because an isolated right aortic arch can be associated with an encircling aortic arch anomaly and may subsequently have a functional repercussion, creating a digestive obstacle (oesophageal compression) and/or a respiratory obstacle (tracheal compression).

Furthermore, indications for surgery in this type of abnormalities are not well-established.

The diagnosis of a vascular artery anomaly is currently mostly made prenatally, with increasing diagnostic accuracy. Indeed, the application of the "3VT view" (e.g. three vessels and tracheae view) in routine prenatal sonographic screening for CHD has contributed to a better identification of such anomalies.

Prenatal diagnosis of an isolated right aortic arch involves the identification of the following aspects: the existence of a left ductus arteriosus may relate to an increased risk of an encircling aortic arch anomaly at birth; the analysis of the different vessels of the aortic arch, which can be difficult because of the fetal circulation and the maternal-fetal conditions of the examination; and the absence of a thymus, which suggests the existence of a genetic anomaly, such as DiGeorge syndrome.

After birth, the evaluation of the functional repercussion of the anomaly remains complex. The incidence of secondary symptoms to encircling abnormalities is estimated at 25%, but varies according to the anomaly: it is very frequent in case of a double aortic arch, variable in case of a right aortic arch with left ductus arteriosus (from 9% to 47% in the literature), absent in case of right aortic arch with right ductus arteriosus. Postnatal echocardiography can only assess the existence of a right aortic arch and check ductus arteriosus closure. The complete anatomical diagnosis of a vascular artery anomaly can only be made by slice cardiac imaging (CT scan or MRI), but in practice these examinations are not routinely performed in the absence of neonatal symptoms.

The aim of this study is to evaluate the accuracy of prenatally diagnosed isolated right aortic arch in terms of anatomy and functional prognosis.

The secondary aims are :

to specify the association of an isolated right aortic arch with a genetic anomaly,
to define the role of CT scan in children prenatally diagnosed with right aortic arch, in terms of diagnosis, prognosis and follow-up,
to evaluate the incidence of respiratory and digestive complications in the first year of life,
to evaluate the indications for surgical management during the first year of life.

time_perspective: Retrospective

ipd_sharing_description: NC

collaborators: Congeital heart disease explorations unit - UE3C Lowendal - Paris


title: Assessment of Survival and Autonomy With Rituximab Plus Chemotherapy or Rituximab Plus Lenalidomide for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma

acronym: Relyage

summary:
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma. Annual incidence increases with age and achieves more than 30 per 100 000 patients 65 years old or over.

Despite high response rates with conventional regimen as R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone), 30% to 40% of patients develop a relapse or a refractory disease, with a poor prognosis. There is no standard chemotherapy in second line for elderly patients, which are not eligible to receive a salvage treatment by high-dose therapy followed by autologous stem cell transplantation. The median progression-free-survival (PFS) is less than one year with the most commonly used regimens including R-Gemcitabine-Oxaliplatin (R-GEMOX) and R-Bendamustine. One the other side, Rituximab plus Lenalidomide, an immunomodulatory agent, is an active new therapeutic approach, with an efficacy proved in a phase II trial with a patients with a prolonged disease-free-survival of 32 months for responders in patients with a median age of 74 years old. This combination is also efficient in the ABC phenotype DLBCL which is more common in elderly patients.

For elderly patients, a management of the geriatric impairment together with lymphoma is required. Indeed, a comprehensive geriatric assessment detects frailty and vulnerability in elderly with a lymphoma and predicts severe treatment related toxicity, treatment settings and progression free survival. Moreover, geriatric intervention improved outcome, autonomy and quality of life. Functional status, assessed by Activities of patients Daily Living (ADL) is an independent predictive factor for feasibility of chemotherapy in elderly patients with cancer. The mini Data Set of DIALOG group is a new simplified geriatric assessment for oncologist.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

collaborators:
cimiez hospital Nice
Institut Bergonié
groupe hospitalier public sud de l'oise
Henri Mondor University Hospital
Centre Henri Becquerel
Hôpital Charles Foix
Saint-Louis Hospital, Paris, France

appel_a_projets: PHRCK

region: Hauts-de-France

nom_etablissement: CHU AMIENS PICARDIE

acronyme: RELYAGE

titre: RELYAGE : Evaluation de la survie avec maintien de l'autonomie avec Rituximab plus chimiothérapie ou Rituximab-Revlimid dans une population de patients âgés atteints d'un lymphome diffus à grandes cellules B en rechute

discipline_principale: cancer

nom_porteur: MAROLLEAU

prenom_porteur: Jean-Pierre


title: Multidisciplinary Development of the Geriatric Core Dataset for Clinical Research in Older Patients With Cancer: A French Initiative With International Survey

acronym: G-CODE

summary:
Older adults with cancer remain underrepresented in cancer clinical trials that establish new standards of care. Geriatric assessment (GA) is defined by geriatricians as a multidimensional interdisciplinary assessment of the general health stat us of the older patient, reviewing the medical, psychosocial, functional and environmental domains. For each domain, several tools are available, but consensus is lacking on which tool to use and the optimal cut-offs or threshold scores. The literature supports the prognostic value of the GA and its utility in weighing the benefits and risks of cancer treatments in older adults. However, GA has not been implemented in routine oncology practice or in cancer clinical trials.

The objective of this project is to develop a set of geriatric data, the Geriatric Core Dataset (G-CODE), to be collected in cancer trials of older patients. The methods rely on a consensus process involving international experts in the field of oncology and geriatrics.

ReferenceType: result

ReferenceCitation: Paillaud E, Soubeyran P, Caillet P, Cudennec T, Brain E, Terret C, Etchepare F, Mourey L, Aparicio T, Pamoukdjian F, Audisio RA, Rostoft S, Hurria A, Bellera C, Mathoulin-Pelissier S; G-CODE collaborators. Multidisciplinary development of the Geriatric Core Dataset for clinical research in older patients with cancer: A French initiative with international survey. Eur J Cancer. 2018 Nov;103:61-68. doi: 10.1016/j.ejca.2018.07.137. Epub 2018 Sep 11.

publisher_dissemination: Elsevier

lead_sponsor: Institut Bergonié

collaborators: Plate-forme PACAN (Elderly and Cancer Platform)

collaborators: City of Hope Comprehensive Cancer Center

location_facility: Institut Bergonié, Comprehensive Cancer Center


title: National Survey on Missed Opportunities to Pre-exposure Prophylaxis for Prevention of Human Immunodeficiency Virus-infection.

summary: Missed opportunity to pre-exposure prophylaxis is a survey study that will be addressed to newly infected with human immunodeficiency virus (HIV) persons. The purposes of this study is to understand why despite the fact that pre-exposure prophylaxis exist, these persons have been contaminated with HIV.

ipd_sharing_description: We need to make a concertation with PI and scientists.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

collaborators: University Hospital Center of Martinique

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility: Centre d'Informations et de soins de l'Immunodéficience Humaine et des hépatites Virales- CHU Sainte-Marguerite

intervention_type: Behavioral


title: A Multisite Randomized Clinical Trial Evaluating Efficacy and Safety of BP1.3656 vs Placebo in Patients With Fatigue Following Ischemic Stroke

summary: Multicenter, randomized, double blind, parallel-group, placebo-controlled proof of concept study evaluating efficacy and safety of BP1.3656 in patients with fatigue following ischemic stroke.

lead_sponsor: Bioprojet

location_country: Switzerland France

location_facility:
Inselspital Berne
Hôpital Pellegrin - CHU BORDEAUX


title: Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherapy and Nivolumab Combination Therapy in Subjects With Virus-Positive and Virus-Negative Solid Tumors

summary:
The purpose of this study to investigate the safety and effectiveness of nivolumab, and nivolumab combination therapy, to treat patients who have virus-associated tumors. Certain viruses have been known to play a role in tumor formation and growth. This study will investigate the effects of the study drugs, in patients who have the following types of tumors:

Anal canal cancer-No longer enrolling this tumor type
Cervical cancer
Epstein Barr Virus (EBV) positive gastric cancer-No longer enrolling this tumor type
Merkel Cell Cancer
Penile cancer-No longer enrolling this tumor type
Vaginal and vulvar cancer-No longer enrolling this tumor type
Nasopharyngeal Cancer - No longer enrolling this tumor type
Head and Neck Cancer - No longer enrolling this tumor type

ReferenceCitation: Ferris RL, Spanos WC, Leidner R, Goncalves A, Martens UM, Kyi C, Sharfman W, Chung CH, Devriese LA, Gauthier H, Chiosea SI, Vujanovic L, Taube JM, Stein JE, Li J, Li B, Chen T, Barrows A, Topalian SL. Neoadjuvant nivolumab for patients with resectable HPV-positive and HPV-negative squamous cell carcinomas of the head and neck in the CheckMate 358 trial. J Immunother Cancer. 2021 Jun;9(6):e002568. doi: 10.1136/jitc-2021-002568. Erratum In: J Immunother Cancer. 2021 Aug;9(8):

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Topalian SL, Bhatia S, Amin A, Kudchadkar RR, Sharfman WH, Lebbe C, Delord JP, Dunn LA, Shinohara MM, Kulikauskas R, Chung CH, Martens UM, Ferris RL, Stein JE, Engle EL, Devriese LA, Lao CD, Gu J, Li B, Chen T, Barrows A, Horvath A, Taube JM, Nghiem P. Neoadjuvant Nivolumab for Patients With Resectable Merkel Cell Carcinoma in the CheckMate 358 Trial. J Clin Oncol. 2020 Aug 1;38(22):2476-2487. doi: 10.1200/JCO.20.00201. Epub 2020 Apr 23.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Naumann RW, Hollebecque A, Meyer T, Devlin MJ, Oaknin A, Kerger J, Lopez-Picazo JM, Machiels JP, Delord JP, Evans TRJ, Boni V, Calvo E, Topalian SL, Chen T, Soumaoro I, Li B, Gu J, Zwirtes R, Moore KN. Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results From the Phase I/II CheckMate 358 Trial. J Clin Oncol. 2019 Nov 1;37(31):2825-2834. doi: 10.1200/JCO.19.00739. Epub 2019 Sep 5.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Navarra - Deposito Adademico Digital Universidad De Navarra

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: University College London - UCL Discovery

unpaywall_oa_status: hybrid

ReferenceCitation: Appelbaum J, Wells D, Hiatt JB, Steinbach G, Stewart FM, Thomas H, Nghiem P, Kapur RP, Thompson JA, Bhatia S. Fatal enteric plexus neuropathy after one dose of ipilimumab plus nivolumab: a case report. J Immunother Cancer. 2018 Aug 31;6(1):82. doi: 10.1186/s40425-018-0396-9.

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_country:
Germany
United Kingdom
Japan
Netherlands
Mexico
Belgium
United States
Korea, Republic of
Spain
Taiwan
France

location_facility:
Local Institution - 0017
Local Institution - 0029
Local Institution - 0031
Local Institution - 0030
Local Institution - 0003
Local Institution - 0021
Local Institution - 0018
Local Institution - 0011
Local Institution - 0041
Local Institution - 0035
Local Institution - 0027
Local Institution - 0002
Local Institution - 0040
Local Institution - 0032
Local Institution - 0039
Local Institution - 0038
Local Institution - 0024
Local Institution - 0028
Local Institution - 0005
Local Institution - 0014
Local Institution - 0034
Local Institution - 0012
Local Institution - 0016
Local Institution - 0037
Local Institution - 0020
Local Institution - 0023
Local Institution - 0033
Local Institution - 0022
Local Institution - 0001
Local Institution
Local Institution - 0008
Local Institution - 0013
Local Institution - 0056
Local Institution - 0004
Local Institution - 0026
Local Institution - 0010
Local Institution - 0019
Local Institution - 0006
Local Institution - 0046
Local Institution - 0036


title: Efficacy and Safety of Plitidepsin in Patients With Advanced Unresectable or Metastatic, Relapsed/Refractory, Dedifferentiated Liposarcoma (DLPS): an Exploratory Phase II Multicenter Trial

acronym: APLIPO

summary: Liposarcomas are soft tissue sarcomas most frequent. We distinguish three subtypes on the basis of their histological and cytogenetic characteristics: well-differentiated liposarcoma / dedifferentiated, myxoid liposarcoma and / or round cell liposarcoma and pleomorphic. Dedifferentiated liposarcomas (LDD) represent 20% of liposarcomas and are characterized by well-differentiated component associated with a contingent sarcomatous differentiation and fat-usually high grade. The LDD are most often rétropértionéal seat. Thus, their development is very long asymptomatic. At diagnosis, tumor volume is often very important making surgical removal impossible in a high proportion of cases. Operable tumors have also a risk of local recurrence by about 50% and about 20% metastatic. Chemotherapy is the only treatment of these advanced forms. However, the currently available drugs (adriamycin, ifosfamide) have only very limited effectiveness. Progression-free survival of patients does not exceed 2 months. The LDD is characterized cytogenetically by the constant presence of two amplicons (1p32 and 6q23) respectively targeting genes MAP3K5 and JUN. These two genes encode proteins involved in the signaling pathway Jun N-terminal kinase (JNK). Activation of JNK is involved in the loss of adipose differentiation and tumor aggressiveness of LDD. The plitidepsin is a drug capable of inducing apoptosis of tumor cells carrying a functional activation of the JNK pathway. This drug has such a pro-apoptotic and anti-proliferative in vitro models of LDD. plitidepsin could represent the treatment of choice for patients with advanced LDD. The objective of this study is to evaluate the anti-tumor activity of plitidepsin patients with locally advanced dedifferentiated liposarcomas and / or metastatic.

status: Terminated

ReferenceCitation: Toulmonde M, Le Cesne A, Piperno-Neumann S, Penel N, Chevreau C, Duffaud F, Bellera C, Italiano A. Aplidin in patients with advanced dedifferentiated liposarcomas: a French Sarcoma Group Single-Arm Phase II study. Ann Oncol. 2015 Jul;26(7):1465-70. doi: 10.1093/annonc/mdv195. Epub 2015 Jun 3.

oa_host_type: repository

unpaywall_oa_status: green

collaborators:
Ministry of Health, France
PharmaMar

sponsor_collaborators:
Institut Bergonié
Ministry of Health, France
PharmaMar

location_facility:
Centre Léon Bérard
Institut Claudius Regaud
Centre Oscar Lambret
Institut Gustave Roussy
Hôpital de la Timone
Institut Curie


title: Interest of a Treatment With the alpha1-blocker Tamsulosin in the Elimination of Pelvis Ureteral Stones

acronym: TAMSULOSINE

summary: Ureteral stones have an important place in daily urological practice, usually causing acute episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to evaluate whether repeated administration of tamsulosin, a drug routinely used in the treatment of lower urinary tract symptoms, could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis.

ReferenceCitation: Resim S, Ekerbicer H, Ciftci A. Effect of tamsulosin on the number and intensity of ureteral colic in patients with lower ureteral calculus. Int J Urol. 2005 Jul;12(7):615-20. doi: 10.1111/j.1442-2042.2005.01116.x.

ReferenceCitation: Wilde MI, McTavish D. Tamsulosin. A review of its pharmacological properties and therapeutic potential in the management of symptomatic benign prostatic hyperplasia. Drugs. 1996 Dec;52(6):883-98. doi: 10.2165/00003495-199652060-00012.

ReferenceCitation: Vincendeau S, Bellissant E, Houlgatte A, Dore B, Bruyere F, Renault A, Mouchel C, Bensalah K, Guille F; Tamsulosin Study Group. Tamsulosin hydrochloride vs placebo for management of distal ureteral stones: a multicentric, randomized, double-blind trial. Arch Intern Med. 2010 Dec 13;170(22):2021-7. doi: 10.1001/archinternmed.2010.447.

lead_sponsor: Rennes University Hospital

collaborators:
Ministry of Health, France
Yamanouchi

sponsor_collaborators:
Rennes University Hospital
Ministry of Health, France
Yamanouchi

location_facility: Service d'Urologie- Hôpital Pontchaillou

location_facility: Service d'Urologie- Hôpital du Val de Grâce

location_facility: Service d'Urologie - Hôpital de La Milétrie

location_facility: Service d'Urologie- Hôpital Robert Debré


title: Cerebral Autoregulation in Pediatric ECMO (ECMOX 2) : Autoregul ECMO - ECMOX2

summary: Children supported by Extra-Corporeal Membrane Oxygenation (ECMO) present a high risk of neurological complications and cerebral autoregulation (CA) impairment may be a risk factor. The first objective is to investigate the association between CA impairments and neurological outcome assessed by the onset of an ANE. The secondary objective is to study the underlying mechanisms influencing CA.

collaborators: Pediatric Intensive Care Unit, Trousseau University Hospital, France

collaborators: Pediatric Intensive Care Unit, Necker University Hospital, France

collaborators: Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, UK

location_country: Italy France

location_facility:
AP-HP Necker Hospital
CHU de Nantes
AP-HP Trousseau Hospital
Giannina Gaslini Institute (IRCCS)


title: French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence

summary:
The aim of this observational study is to evaluate the utilization in the clinical practice, effectiveness, explantation and re-intervention rate, complications and adverse events of InterStim system in patients indicated to Sacral Neuromodulation therapy for fecal incontinence.

This study will provide additional data about safety and effectiveness of the usage of InterStim system in fecal incontinence environment and at the same time will confirm that results from clinical trials can be transposed to clinical practice.

ReferenceCitation: Matzel KE, Kamm MA, Stosser M, Baeten CG, Christiansen J, Madoff R, Mellgren A, Nicholls RJ, Rius J, Rosen H. Sacral spinal nerve stimulation for faecal incontinence: multicentre study. Lancet. 2004 Apr 17;363(9417):1270-6. doi: 10.1016/S0140-6736(04)15999-0.

ReferenceCitation: Jarrett ME, Varma JS, Duthie GS, Nicholls RJ, Kamm MA. Sacral nerve stimulation for faecal incontinence in the UK. Br J Surg. 2004 Jun;91(6):755-61. doi: 10.1002/bjs.4545.

ReferenceCitation: Uludag O, Koch SM, van Gemert WG, Dejong CH, Baeten CG. Sacral neuromodulation in patients with fecal incontinence: a single-center study. Dis Colon Rectum. 2004 Aug;47(8):1350-7. doi: 10.1007/s10350-004-0589-9.

ReferenceCitation: Altomare DF, Rinaldi M, Lobascio P, Marino F, Giuliani RT, Cuccia F. Factors affecting the outcome of temporary sacral nerve stimulation for faecal incontinence. The value of the new tined lead electrode. Colorectal Dis. 2011 Feb;13(2):198-202. doi: 10.1111/j.1463-1318.2009.02088.x.

ReferenceCitation: Mellgren A, Wexner SD, Coller JA, Devroede G, Lerew DR, Madoff RD, Hull T; SNS Study Group. Long-term efficacy and safety of sacral nerve stimulation for fecal incontinence. Dis Colon Rectum. 2011 Sep;54(9):1065-75. doi: 10.1097/DCR.0b013e31822155e9.

ReferenceCitation: Altomare DF, Ratto C, Ganio E, Lolli P, Masin A, Villani RD. Long-term outcome of sacral nerve stimulation for fecal incontinence. Dis Colon Rectum. 2009 Jan;52(1):11-7. doi: 10.1007/DCR.0b013e3181974444.

ReferenceCitation: Wexner SD, Coller JA, Devroede G, Hull T, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. 2010 Mar;251(3):441-9. doi: 10.1097/SLA.0b013e3181cf8ed0.

ReferenceCitation: Tjandra JJ, Chan MK, Yeh CH, Murray-Green C. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study. Dis Colon Rectum. 2008 May;51(5):494-502. doi: 10.1007/s10350-007-9103-5. Epub 2008 Feb 16.

ReferenceCitation: Leroi AM, Parc Y, Lehur PA, Mion F, Barth X, Rullier E, Bresler L, Portier G, Michot F; Study Group. Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter double-blind crossover study. Ann Surg. 2005 Nov;242(5):662-9. doi: 10.1097/01.sla.0000186281.09475.db.

ReferenceCitation: Tan E, Ngo NT, Darzi A, Shenouda M, Tekkis PP. Meta-analysis: sacral nerve stimulation versus conservative therapy in the treatment of faecal incontinence. Int J Colorectal Dis. 2011 Mar;26(3):275-94. doi: 10.1007/s00384-010-1119-y. Epub 2011 Jan 29.

ReferenceCitation: Matzel KE, Lux P, Heuer S, Besendorfer M, Zhang W. Sacral nerve stimulation for faecal incontinence: long-term outcome. Colorectal Dis. 2009 Jul;11(6):636-41. doi: 10.1111/j.1463-1318.2008.01673.x. Epub 2008 Aug 21.

ReferenceCitation: Meurette G, Siproudhis L, Leroi AM, Damon H, Urs Josef Keller D, Faucheron JL; French Faecal Registry Study Group. Sacral neuromodulation with the InterStim system for faecal incontinence: results from a prospective French multicentre observational study. Colorectal Dis. 2021 Jun;23(6):1463-1473. doi: 10.1111/codi.15507. Epub 2021 Mar 12.

publisher_dissemination: Wiley

lead_sponsor: MedtronicNeuro

collaborators:
Medtronic France SAS
Medtronic MCRI

sponsor_collaborators:
MedtronicNeuro
Medtronic France SAS
Medtronic MCRI

location_facility:
CHU Dupuytren
CHU Estaing
APM Hopital Nord
CHU La Milétrie
CHU Rennes - Hôpital Pontchaillou
Polyclinique Pays Basque Sud
CHU Toulouse - Hotel Dieu PURPAN
CHU Charles Nicolle
CHU Grenoble - Hôpital Michallon
Hôpital Saint Joseph
CHU Hautepierre
CHU Nantes - Hotel Dieu
Clinique St Jean du Languedoc
Hopital Edouard Herriot
GH Diaconesses Croix St Simon
CHRU Lille - Hôpital Claude Huriez

intervention_type: Device


title: Immuno-Génétique, Inflammation, Retro-Virus, Environnement

acronym: I-Give

summary:
Immunology combined to neurobiology now offer prominent tools to yield biomarkers, so far missing in psychiatry, and to design innovative treatment approaches based on the discovery of new molecular and cellular targets. As Bipolar Disorder and Schizophrenia are now known to be significantly associated with neuro-inflammation, the project I-GIVE will combine multidisciplinary approaches (clinical, viral, immunological, genetic) to explore a global hypothesis placing the Human Endogenous Retro-Virus, HERV-W, at the crossroads between susceptibility to environmental factors (such as winter-spring births, infections, urbanicity…) and genetic factors controlling immune responses.

Thus I-GIVE will allow identification of new biomarkers and their correlation with clinical profiles and immuno-inflammatory/immuno-genetic markers, and description of patho-physiological mechanisms of a psychiatric disorder. In addition, I-GIVE should help to design innovative treatments and foster personalized psychiatry tailored to the needs of each patient. Notably, monoclonal antibodies anti-HERV-W Env will be assessed in a preclinical model for their ability to slow, stop, or even reverse the progression of the psychosis in patients. I-GIVE project should thus lead to major results that will have strong impacts on the scientific community, pharmaceutical industries and, in a longer term, on improvement of patients suffering Bipolar Disorder or Schizophrenia and their family.

primary_purpose: Basic Science

lead_sponsor: Pr. Marion Leboyer

sponsor_collaborators:
Pr. Marion Leboyer
National Research Agency, France
Assistance Publique - Hôpitaux de Paris

location_facility: Psychiatry Department of R. Dubos Hospital

location_facility: Psychiatry Department of Perrens Hospital

location_facility: Psychiatry Department of Mondor Hospital

location_facility: Clinical Investigations Center of Mondor Hospital

intervention_type: Genetic


title: Phase I/II Study of LY2228820 With Radiotherapy Plus Concomitant TMZ in the Treatment of Newly Diagnosed Glioblastoma

acronym: GLYRad

summary:
Glioblastomas are extremely resistant to treatment, including radiotherapy and/or chemotherapy. Mitogen-activated protein kinase (MAPK) cascades are key signaling pathways involved in the regulation of normal cell proliferation, survival and differentiation. Activation of p38 MAPK has been associated with a poor prognosis among patients with glioblastoma during the temozolomide (TMZ) era and represents a compensatory response by tumor cell to environmental stress such as radiation or chemotherapy.

LY2228820 is a potent and selective inhibitor of p38 MAPK, and reduces phosphorylation of its cellular target, MAPK-activated protein kinase 2 (MAPKAPK-2) . LY2228820 is a good candidate to target malignant glioma resistance to the gold standard treatment combining radiation and TMZ by acting on both tumor and stromal cells.

The primary objectives of this study were to determine the recommended dose of LY2228820 in combination with TMZ and radiotherapy during chemoradiotherapy period (phase I) and to estimate the 6-month progression free survival (PFS) rate of patients treated with LY2228820 when administered at the recommended dose in combination with radiotherapy and concomitant TMZ (phase II)

lead_sponsor: Centre Jean Perrin

sponsor_collaborators:
Centre Jean Perrin
National Cancer Institute, France
ARC Foundation for Cancer Research

location_facility:
Institut Bergonié
Centre François Baclesse
Centre Paul Strauss
CHU Amiens Sud-Salouel
Centre Georges François Leclerc
Centre Jean Perrin


title: Acrobat Coronary Stent System Effectiveness European Study (European Multicenter Effectiveness Randomized Study of Svelte Medical Systems Acrobat Stent on a Wire Compared to Other BMS PCI in de Novo Coronary Lesions) ACES Trial

acronym: ACES

summary: The purpose of this randomized controlled trial (RCT) is to demonstrate the clinical benefit and impact on resource utilization of percutaneous coronary interventions (PCI) with the Svelte Acrobat Stent System compared to any other CE marked bare metal stent (BMS) implantable via direct stenting or after lesion pre-dilation, in patients with coronary lesions that are eligible for direct stenting and who are recruited and treated so as to reflect real-life routine practice.

ReferenceCitation: Piscione F, Piccolo R, Cassese S, Galasso G, D'Andrea C, De Rosa R, Chiariello M. Is direct stenting superior to stenting with predilation in patients treated with percutaneous coronary intervention? Results from a meta-analysis of 24 randomised controlled trials. Heart. 2010 Apr;96(8):588-94. doi: 10.1136/hrt.2009.183277.

ReferenceCitation: Shao C, Stella PR, Agostoni P. Complex made easy: left anterior descending artery trifurcation lesion completely treated with a single device. J Invasive Cardiol. 2012 Aug;24(8):E164-6.

ReferenceCitation: de Ribamar Costa J, Abizaid A, Stella P, Fernandez A, Granada J, Feres F, Serruys P. Preliminary results of the svelte trial: first-in-man assessment of the novel acrobat™ SOAW (Stent-On-A-Wire) coronary system. J Am Coll Cardiol. 2011;57(14s1):E1658-E1658. doi:10.1016/S0735-1097(11)61658-6

lead_sponsor: Svelte Medical Systems Europe

location_country: Spain Belgium France

location_facility: CHU Bordeaux Sud - Hôpital Cardiologique Haut Lévêque


title: Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years

acronym: CAPSULE

summary:
Patients aged less than 18-y with validated 8% capsaicin patch treatment in routine healthcare will be offered to participate the study. If they accept it as well as their parents, they will be included in the study .

Medical data will be recorded and at home, the child or his family will collect pain assessment data.

Tolerance will be monitored at home by phone call from investigational team every 24 hours until normalization. (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.) Children will be assessed via scales at inclusion and 1-month, 3-month and 6-month.

lead_sponsor: University Hospital, Brest

collaborators:
Fondation de France
Fondation Apicil

sponsor_collaborators:
University Hospital, Brest
Fondation de France
Fondation Apicil

location_facility:
CHU Toulouse
CHU Limoges
CHR Bourg en Bresse
CHU Lyon
CHU Marseille
CHRU Strasbourg
CHU Rouen
Institut Gustave Roussy
CHU Robert Debré
CHU Nancy
CHU Angers
CHU Nantes
CHU Montpellier
CHU de Brest
CHU Caen
CHU Trousseau
CHU Grenoble
CHU Bordeaux
CHU Lille


title: Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia

acronym: CLEAN-MARGIN

summary:
This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE).

It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.

primary_purpose: Diagnostic

ReferenceCitation: Wallace MB, Crook JE, Saunders M, Lovat L, Coron E, Waxman I, Sharma P, Hwang JH, Banks M, DePreville M, Galmiche JP, Konda V, Diehl NN, Wolfsen HC. Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus. Gastrointest Endosc. 2012 Sep;76(3):539-47.e1. doi: 10.1016/j.gie.2012.05.004. Epub 2012 Jun 28.

lead_sponsor: Mauna Kea Technologies

sponsor_collaborators:
Mauna Kea Technologies
Cellvizio Inc.

location_country:
United States
United Kingdom
France

location_facility:
Mayo Clinic
Veterans Affairs Hospital
University of Washington Medical Center
University of Chicago Hospital
Centre Hospitalier Universitaire
University College London Hospital


type: Registry Identifier

title: New Strategies to Detect Cancers in Carriers of Mutations in RB1: Blood Tests Based on Tumor-educated Platelets, or Extracellular Vesicles.

acronym: NIRBTEST

summary:
Rationale: Individuals with a cancer predisposition due to a mutation in the paradigm tumor suppressor gene RB1, have a high risk to develop the childhood cancer retinoblastoma (Rb). Biopsies are not possible in Rb, before treatment selection. Heritable Rb patients have also a high risk to develop other types of second primary, either childhood or adult, malignancies (SPMs), notably sarcomas and melanomas. Remarkably, SPMs are now the leading cause of death in heritable-Rb-survivors. Unfortunately, there are no well-developed regular surveillance protocols for SPMs in Rb survivors available right now. Recently, new non-invasive cancer test have been developed, based on either RNA-sequencing data from platelets (ThromboSeq), or on extracellular membrane vesicles (EVs) derived from tumor cells present in blood.

Objective:

Determine the non-cancerous baseline in adult RB1-mutation carriers (heritable-Rb-survivors).
Contribute to the biobanking of blood and cancerous tissues from RB1-mutation carriers with SPMs.
The development of blood-based tests, either platelet or EV-based, for the detection of (the type of) tumors in RB1-mutation carriers.

Study design: Cross-sectional multicenter trial.

Study population:

40 Rb patients (children),
40 controls (children),
153 Rb survivors (adults),
153 controls (adults),
10 Rb survivors with SPM (children/adults).

Main study parameters/endpoints:

Determine the non-cancerous baseline in adult RB1-mutation carriers (heritable-Rb-survivors).
Contribute to the biobanking of blood and cancerous tissues from RB1-mutation carriers with SPMs.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Two blood samples totalling 10ml blood will be collected for every participant. Additionally, a short questionnaire has to be filled in concerning their and their family's cancer history. Blood draws will be done, when participants are already present in the hospital for other appointments, and thus no extra visits are required. For all children, blood will be collected through an already present IV, and so no extra venepuncture is required. Children have to be included because Rb is a tumor only present in this patient group.

time_perspective: Cross-Sectional

lead_sponsor: Amsterdam UMC, location VUmc

sponsor_collaborators:
Amsterdam UMC, location VUmc
University Hospital, Essen
Institut Curie
Ligue contre le cancer, France

location_country: Germany Netherlands France

location_facility:
Amsterdam UMC, location VUmc
University Hospital Essen (UHE)
Institute Curie


title: Evaluation of the Beckman Coulter Access HIV Ag/Ab Combo Assay as an Aid in the Diagnosis of HIV-1 and/or HIV-2 Infection: EU Clinical Trial Protocol

summary: The objective of this study is the collection and testing of clinical samples to determine the clinical performance of the Access HIV Ag/Ab Combo assay on the DxI 9000 Access Immunoassay Analyzer

lead_sponsor: Beckman Coulter, Inc.

location_facility: Etablissement Français du Sang (EFS) Hauts-de-France - Normandie

location_facility: UPR Lille, Établissement français du sang Hauts-de-France - Normandie

location_facility: Laboratoire de Virologie, Laboratoire associé au CNR du VIH

intervention_type: Diagnostic Test


title: Phase II Trial Assessing the Efficacy of Immuno-Radiation Abscopal Effect in Patients With Metastatic Cancers (IRAM)

acronym: IRAM

summary: The proposed theory is based on combination of radiation therapy with usual targeted therapies capable of ADCC (Antibody-Dependant Cell Cytotoxicity). This association could enhance in a additive/synergistic way the benefic impact of immune system activation on tumor control. Stereotactic Body Radio-Therapy (SBRT) will be combined with the first line chemotherapy for metastatic breast, colorectal or VADS (upper aerodigestive tract) cancers. The IRAM study objective is to highlight a possible abscopal effect of this combination for metastatic cancer patients.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Institut de Cancérologie de la Loire

collaborators: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Institut de Cancérologie Lucien Neuwirth


acronym: CIRSARC

summary: The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy) improves the outcome of high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is metastatic progression-free survival (M-PFS, after 3 years of follow-up).

sponsor_collaborators:
Institut Bergonié
Novartis
Chugai Pharma France

location_facility: Institut de Cancérologie de l'Ouest - Site René Gauducheau

title: Phase III Trial Investigating the Potential Benefit of Intensified Peri-operative Chemotherapy With in High-risk CINSARC Patients With Resectable Soft-tissue SARComas

collaborators:
Novartis
Chugai Pharma France


title: Lead Time of the Methotrexate Establishment and Vaccinal Protection Against the Pneumococcal Agent in Patients Affected With Rheumatoid Polyarthritis

acronym: VACIMRA

summary: To estimate the rate of immunological answer 1 month after antipneumococcal vaccination by the conjugated vaccine Prevenar13 ® in patients suffered from rheumatoid polyarthritis and who begin a treatement by methotrexate either in the same time, either 1 month later.

lead_sponsor: University Hospital, Montpellier

collaborators:
Hôpital Cochin
Pfizer

sponsor_collaborators:
University Hospital, Montpellier
Hôpital Cochin
Pfizer

location_country: Monaco France

location_facility: CHPG Monaco - Hôpital Prince Grace de Monaco


title: A Phase I Placebo-controlled, Double-blind, Dose Escalation Clinical Trial to Evaluate the Safety and Immune Responses of Imcyse's IMCY-0098 in Patients With Recent Onset Type 1 Diabetes

summary: This clinical study will evaluate the safety of an innovative approach expected to be disease-modifying by stopping the auto-immune-mediated destruction of islet β-cells in the pancreas. Three doses of the investigational product will be tested in successive cohorts. Although safety is the first objective of this study, we will gather efficacy data and perform a set of immunological tests to further understand the mechanism of action of this new approach in young adults with recent onset type 1 diabetes.

ReferenceCitation: Carlier VA, VanderElst L, Janssens W, Jacquemin MG, Saint-Remy JM. Increased synapse formation obtained by T cell epitopes containing a CxxC motif in flanking residues convert CD4+ T cells into cytolytic effectors. PLoS One. 2012;7(10):e45366. doi: 10.1371/journal.pone.0045366. Epub 2012 Oct 9.

ReferenceCitation: Malek Abrahimians E, Carlier VA, Vander Elst L, Saint-Remy JM. MHC Class II-Restricted Epitopes Containing an Oxidoreductase Activity Prompt CD4(+) T Cells with Apoptosis-Inducing Properties. Front Immunol. 2015 Sep 2;6:449. doi: 10.3389/fimmu.2015.00449. eCollection 2015.

ReferenceCitation: Malek Abrahimians E, Vander Elst L, Carlier VA, Saint-Remy JM. Thioreductase-Containing Epitopes Inhibit the Development of Type 1 Diabetes in the NOD Mouse Model. Front Immunol. 2016 Mar 2;7:67. doi: 10.3389/fimmu.2016.00067. eCollection 2016. Erratum In: Front Immunol. 2018 Jul 09;9:1600.

lead_sponsor: Imcyse SA

location_country:
Germany
Lithuania
United Kingdom
Denmark
Sweden
Belgium
France

location_facility: St. Bartholomew's Hospital (Barts Health NHS Trust)

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Oxford University Hospitals NHS Foundation Trust


title: A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

summary: The primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.

ReferenceCitation: Goubard A, Humbert M, Mansfield C, Hermine O, Dubreuil P, et al. In Vivo Assessment of the Next Generation Microtubule-Destabilizing Agent AB8939 in Patient-derived Xenograft Models of Acute Myeloid Leukemia. Blood (2019) 134 (Supplement_1): 5142. doi.org/10.1182/blood-2019-127143

ReferenceCitation: Goubard A, Humbert M, Mansfield C, Hermine O, Dubreuil P, et al. AB8939, a Microtubule-Destabilizing Agent with Potential to Overcome Multidrug Resistance, is Active Across the Range (M0-M7) of Acute Myeloid Leukemia Subtypes. Blood (2019) 134 (Supplement_1): 5154. doi.org/10.1182/blood-2019-127021

ReferenceCitation: Humbert M, Goubard A, Mansfield C, Hermine O, Dubreuil P, et al. Anticancer Activity of a Highly Potent Small Molecule Tubulin Polymerization Inhibitor, AB8939. Blood (2019) 134 (Supplement_1): 2075. doi.org/10.1182/blood-2019-122540

lead_sponsor: AB Science

location_country:
United States
Spain
Greece
France

location_facility: National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation Unit

location_facility: General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante)

location_facility: Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío)


title: Impact of Early Palliative Care on Overall Survival of Patients With Metastatic Upper Gastrointestinal Cancers, Treated With First-line Chemotherapy: a Randomized Phase III Trial

summary: This prospective, randomized, open-label and multicenter phase III study is aimed to estimate the survival benefit of Early Palliative Care (EPC) combined with standard oncology care including first-line chemotherapy (experimental arm) over standard oncology care only (standard arm), in patients with metastatic upper gastrointestinal cancers (gastric cancer, pancreatic cancer, biliary tract cancers).

primary_purpose: Supportive Care

ReferenceCitation: Hutt E, Da Silva A, Bogart E, Le Lay-Diomande S, Pannier D, Delaine-Clisant S, Le Deley MC, Adenis A. Impact of early palliative care on overall survival of patients with metastatic upper gastrointestinal cancers treated with first-line chemotherapy: a randomised phase III trial. BMJ Open. 2018 Jan 23;8(1):e015904. doi: 10.1136/bmjopen-2017-015904. Erratum In: BMJ Open. 2019 May 30;9(5):e015904corr1.

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

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

lead_sponsor: Centre Oscar Lambret

sponsor_collaborators:
Centre Oscar Lambret
Ligue contre le cancer, France
Région Nord-Pas de Calais, France
National Cancer Institute, France

location_facility: Institut de cancérologie de Lorraine, Nancy

location_facility: Institut de cancérologie de l'Ouest, Nantes

location_facility: Institut Curie, site de Saint Cloud, Hopital

location_facility: Centre Hospitalier Universitaire de STRASBOURG

location_facility: Institut de cancérologie de l'Ouest-site PAUL

location_facility: CHU de Nantes, CHU - hôpital Nord Laennec,

location_facility: Centre Georges Francois Leclerc de DIJON


title: Impact of Early Enteral vs. Parenteral Nutrition on Preservation of Gut Mucosa Integrity in Patients Requiring Mechanical Ventilation and Catecholamines: an Ancillary Study of the NUTRIREA2 Trial (NCT01802099)

summary: To demonstrate that a strategy involving early first-line enteral nutrition is associated with improved preservation of gut mucosa integrity, as assessed based on the plasma citrulline level at H72, compared to a strategy involving early first-line parenteral nutrition

lead_sponsor: Centre Hospitalier Departemental Vendee

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

location_facility:
CH de Dieppe
Centre hospitalier d'Annecy
CHU Lille
CHU Tours
CHU Saint Louis
CHU Amiens


title: Impact of Early Enteral vs. Parenteral Nutrition on Risk of Gastric-Content Aspiration in Patients Requiring Mechanical Ventilation and Catecholamines: an Ancillary Study of the NUTRIREA2 Trial (NCT01802099)

summary: To evaluate the impact of enteral nutrition on microaspiration of gastric content and pharyngeal secretions

ReferenceCitation: Nseir S, Le Gouge A, Lascarrou JB, Lacherade JC, Jaillette E, Mira JP, Mercier E, Declercq PL, Sirodot M, Piton G, Tinturier F, Coupez E, Gaudry S, Djibre M, Thevenin D, Pasco J, Balduyck M, Zerimech F, Reignier J. Impact of nutrition route on microaspiration in critically ill patients with shock: a planned ancillary study of the NUTRIREA-2 trial. Crit Care. 2019 Apr 5;23(1):111. doi: 10.1186/s13054-019-2403-z.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

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

location_facility:
CHU Louis Mourier
Centre hospitalier d'Annecy
CHU Lille
CHU Tours
CHU Saint Louis
CHU Amiens


acronym: Inter-B-NHL ritux 2010

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

summary: Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children and adolescent with primary mediastinal large B cell lymphoma in terms of event free survival.

ReferenceCitation: Burke GAA, Minard-Colin V, Auperin A, Alexander S, Pillon M, Delgado R, Zsiros J, Uyttebroeck A, Dartigues P, Miles RR, Kazanowska B, Chiang AK, Haouy S, Bollard CM, Csoka M, Wheatley K, Barkauskas DA, Adamson PC, Vassal G, Patte C, Gross TG. Dose-Adjusted Etoposide, Doxorubicin, and Cyclophosphamide With Vincristine and Prednisone Plus Rituximab Therapy in Children and Adolescents With Primary Mediastinal B-Cell Lymphoma: A Multicenter Phase II Trial. J Clin Oncol. 2021 Nov 20;39(33):3716-3724. doi: 10.1200/JCO.21.00920. Epub 2021 Sep 27.

location_facility: Associazione Italiana di Ematologia ed Oncologia Pediatrica

location_facility: 2nd Dept. of Pediatrics Semmelweis Univ.

location_facility: Children Oncology Group Operations centres

location_facility: Sociedad Española de Hematología y Oncología Pediátricas

title: Intergroup Trial for Children or Adolescents With B-Cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase II Trial of DA-EPOCH-Rituximab in PMLBL

location_country:
Italy
Poland
Hungary
United Kingdom
Netherlands
Belgium
Spain
Canada
France


title: A Randomized, Phase 3 Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment of Patients With Pancreatic Adenocarcinoma

summary: This is an open-label, multicenter, randomized, Phase 3 study in patients with ductal adenocarcinoma of the pancreas who have failed only one prior line of systemic anti-cancer therapy for advanced pancreatic cancer and have measurable disease.

lead_sponsor: ERYtech Pharma

location_facility: University of Minnesota Health Clinics and Surgery Center

location_facility: University of California Davis Medical Center


summary: The aim of the trial is to test whether adding 6 injections of rituximab to standard "Lymphome malin B" LMB chemotherapy regimen improves the Event Free Survival (EFS) compared with LMB chemotherapy alone in children / adolescents with advanced stage B-cell Non-Hodgkin Lymphoma (NHL) / B-Acute Leukemia (B-AL)(stage III and LDH > Nx2, any stage IV or B-AL).

ReferenceCitation: Minard-Colin V, Auperin A, Pillon M, Burke GAA, Barkauskas DA, Wheatley K, Delgado RF, Alexander S, Uyttebroeck A, Bollard CM, Zsiros J, Csoka M, Kazanowska B, Chiang AK, Miles RR, Wotherspoon A, Adamson PC, Vassal G, Patte C, Gross TG; European Intergroup for Childhood Non-Hodgkin Lymphoma; Children's Oncology Group. Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children. N Engl J Med. 2020 Jun 4;382(23):2207-2219. doi: 10.1056/NEJMoa1915315.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: The University of Hong Kong (Clinical Trials Centre)

title: Intergroup Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase III Trial

location_country:
Italy
Poland
Hungary
United Kingdom
Netherlands
Belgium
China
Spain
Canada
France


acronym: SAVE-VEMED

lead_sponsor: Sanofi

summary:
The primary objective was to compare the efficacy of once daily [q.d] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the primary prevention of Venous Thromboembolic Events [VTE] in patients hospitalized for acute medical illness.

The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.

location_facility: sanofi-aventis Australia & New Zealand administrative office

title: A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Primary Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility

location_country:
Germany
New Zealand
Australia
Canada
France
Czech Republic
Lithuania
Hungary
United States
Latvia
Ukraine
India
Romania
Estonia
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Russian Federation


title: Impact of a Personalized Video in Oral Hygiene Motivation

acronym: GOPERIO

summary: Impact of a personalized video in oral hygiene motivation: The study hypothesis is that the use of a personalized oral hygiene video, made available to the patient via a cloud-based system, in conjunction with a text-based two-way recall system will increase patient compliance, hence leading to improvement or oral hygiene.

ReferenceCitation: Garyga V, Pochelu F, Thivichon-Prince B, Aouini W, Santamaria J, Lambert F, Maucort-Boulch D, Gueyffier F, Gritsch K, Grosgogeat B. GoPerio - impact of a personalized video and an automated two-way text-messaging system in oral hygiene motivation: study protocol for a randomized controlled trial. Trials. 2019 Dec 10;20(1):699. doi: 10.1186/s13063-019-3738-0.

lead_sponsor: Hospices Civils de Lyon

sponsor_collaborators:
Hospices Civils de Lyon
University of Liege

location_country: Belgium France

location_facility: Hospices Civils de Lyon - Service de Consultations et de Traitements Dentaires


title: Short Duration Therapy of Acute Hepatitis C Genotypes 1 or 4: Efficacy and Tolerability of Grazoprevir 100mg/Elbasvir 50mg During 8 Weeks

acronym: SAHIV

summary: The purpose of this study is to assess the rate of sustained virological response (SVR) 12 weeks after 8-week oral treatment with grazoprevir 100mg/elbasvir 50mg (MRK-combo) in patients with acute hepatitis C genotype1 or 4.

ReferenceCitation: Gambotti L, Batisse D, Colin-de-Verdiere N, Delaroque-Astagneau E, Desenclos JC, Dominguez S, Dupont C, Duval X, Gervais A, Ghosn J, Larsen C, Pol S, Serpaggi J, Simon A, Valantin MA, Velter A; Acute hepatitis C collaborating group. Acute hepatitis C infection in HIV positive men who have sex with men in Paris, France, 2001-2004. Euro Surveill. 2005 May;10(5):115-7.

ReferenceCitation: Fierer DS, Dieterich DT, Fiel MI, Branch AD, Marks KM, Fusco DN, Hsu R, Smith DM, Fierer J. Rapid progression to decompensated cirrhosis, liver transplant, and death in HIV-infected men after primary hepatitis C virus infection. Clin Infect Dis. 2013 Apr;56(7):1038-43. doi: 10.1093/cid/cis1206. Epub 2012 Dec 21.

ReferenceCitation: European AIDS Treatment Network (NEAT) Acute Hepatitis C Infection Consensus Panel. Acute hepatitis C in HIV-infected individuals: recommendations from the European AIDS Treatment Network (NEAT) consensus conference. AIDS. 2011 Feb 20;25(4):399-409. doi: 10.1097/QAD.0b013e328343443b. No abstract available.

ReferenceCitation: Rockstroh JK, Nelson M, Katlama C, Lalezari J, Mallolas J, Bloch M, Matthews GV, Saag MS, Zamor PJ, Orkin C, Gress J, Klopfer S, Shaughnessy M, Wahl J, Nguyen BY, Barr E, Platt HL, Robertson MN, Sulkowski M. Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. Lancet HIV. 2015 Aug;2(8):e319-27. doi: 10.1016/S2352-3018(15)00114-9. Epub 2015 Jul 9. Erratum In: Lancet HIV. 2015 Aug;2(8):e316. Lancet HIV. 2015 Oct;2(10):e416.

ipd_sharing: Yes

ipd_sharing_description: All data are available as IPD. An official request must be made to the Principal Investigator. The request will be reviewed by the Scientific Committee. If approved, data will be exchanged according to European Union General Data Protection Regulation.

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

location_facility:
Hôpital Tenon
CHU de Lyon
CHU de Nice
Hôpital La Pitié-Salpêtrière
Hôpital Bichat
Hôpital Saint-Antoine


title: A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions

summary: The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

ReferenceCitation: Morice MC. XIENCE V SPIRIT WOMEN clinical trial: characterization of the female population undergoing stent implantation. Womens Health (Lond). 2008 Sep;4(5):439-43. doi: 10.2217/17455057.4.5.439.

ReferenceCitation: Franzone A, Zaugg S, Piccolo R, Modena MG, Mikhail GW, Ferre JM, Strasser R, Grinfeld L, Heg D, Juni P, Windecker S, Morice MC. A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study. PLoS One. 2017 Aug 10;12(8):e0182632. doi: 10.1371/journal.pone.0182632. eCollection 2017.

endpoint_id: nbfzapbzoypsdcgeiryx

repository_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

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

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

evidence: oa repository (semantic scholar lookup)

publisher_dissemination: Public Library of Science

lead_sponsor: Abbott Medical Devices

location_country: Germany Italy Poland Hungary Argentina Denmark Norway Brazil Netherlands Austria Belgium Switzerland Latvia Spain France

location_facility: Semmelweis University, Department of Cardiovascular Surgery

location_facility: Hosital Italiano de Buenos Aires - Cardiologia

location_facility: Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud

location_facility: Technische Universität Dresden, Medizinische Klinik II - Kardiologie

location_facility: Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II

location_facility: Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia

location_facility: Instituto Cardiovascular de Buenos Aires-ICBA

location_facility: Latvian Center of Cardiology, P. Stradina University Hospital

location_facility: Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO

location_facility: Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Kardiologische Klinik Herz- und Diabeteszentrum