title: Differential Vulnerability of Individual Thalamic Nuclei: Toward New Biomarkers in Multiple Sclerosis

acronym: THALNUC-MS

summary: The thalamus is composed of several nuclei interlocked in a complex anatomy. In multiple sclerosis (MS), the thalamus can be altered due to disconnection by white matter lesions and due to direct damages that could be partly mediated by CSF. Due to such pathophysiology and complex anatomy, some nuclei could be more vulnerable to multiple sclerosis than others. We will test this hypothesis by using a new algorithm to automatically segment several nuclei that we will be applied to the French national MS database

time_perspective: Other

lead_sponsor: University Hospital, Bordeaux


title: Involvement of Polymorphonuclear Neutrophils and Platelets in Severe Form of COVID-19

acronym: NeutroVID

summary: The main objective is to quantify the population of reverse migrating neutrophils in patients with COVID-19.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

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

location_facility: Intensive care department, Hôpital Saint Antoine

lead_sponsor_type: academique

status_simplified: Unknown


title: Set up a Community Online in a Virtual Community Game for Tobacco Prevention in Teenagers

acronym: SCOTT

summary:
The main objective of the SCOTT project is to reduce tobacco experimentation of teenagers through an online intervention based on social networking and empowerment of users.

Specific objectives of this emerging project are : 1. To develop or identify an online community dedicated to teenagers where the investigators will develop anti-smoking skills and norms. It will be based on social cognitive theory and will combine multiple functionalities based on the current practices and preferences of adolescents on internet and mobile; ensuring user safety, regulatory and ethical issues ; 2. To analyse the adoption, acceptance and the usability of SCOTT among users in a limited scale 3.To develop SCOTT process and impact assessment methodology.

Research hypothesis Providing access to prevention in an online community will: 1) Strengthen anti-smoking skills 2) Enhance the empowerment of users 3) Allow the implementation of health interventions 4) Improve indicators of tobacco consumption in young people Methods The overall methodology of the project relies on a multidisciplinary approach with a consortium of French experts in public health (health promotion and epidemiology), education science, information and communication technologies, medical informatics, adolescent medicine, adolescent addictology, social sciences, ethics and law. The project will be led in 3 parts: 1) Development of the intervention - using the Integrate, Design, Assess, and Share (IDEAS) framework. Using qualitative methods (individual interview, focus groups), multidisciplinary team brainstorming, works meeting and quantitative assessment of SCOTT quality; the investigators will (a) empathize with target users, (b) specify target behavior, (c) ground in behavioral theory, (d) ideate implementation strategies, (e) prototype potential products, (f) gather user feedback, (g) build a minimum viable product, 2) Pilot study : (h) SCOTT will be deploying on a small scale to assess its usability; 3) Development of the large-scale evaluation protocol - following the recommendations of the Medical Research Council concerning the evaluation of complex interventions. The investigators will (i) develop, based on the results of the pilot test, the SCOTT process evaluation methodology, (j) develop the SCOTT impact / effectiveness evaluation methodology.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ipd_sharing: No

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

intervention_type: Behavioral

status_simplified: Completed


title: Risk of Contamination by COVID-19 During Oral Care With Aerosolization

acronym: Bu-Covid

summary:
The sudden Covid-19 pandemic has led all healthcare workers to adapt to an unprecedented situation by continuing to provide care while protecting themselves and their patients. Medical care with aerosolization systems is particularly of risk because of the strong propagation of the droplets they generate, especially during oral care. Considering the high risk of transmission of the SARS-CoV-2 virus in dental structures remain essential and still very challenging. The need to put in place care procedures to protect the nursing staff and patients is definitely more than necessary. Dental protection equipments against this emergent virus have progressively integrated daily practice, but, to the knowledge of the investigators, no study has precisely evaluated their efficiency.

The main objective of this study is to estimate the risk of dental practitioners to be contaminated by SARS-CoV-2 during dental procedures with or without aerosolization procedures.

For this, after their informed consent, vaccinated dental practitioners or practitioners with a positive covid serological tests of the dental department of Charles Foix hospital will receive individually forty to fifty COVID+ patients. COVID + patients will be included a maximum of one week after the diagnosis of the pathology. Patient care will be determined and performed according to standard practice as part of their standard management and without interference with the study. The usual measures to protect caregivers. The included patients will undergo an oral dental procedure either with aerosolisation or not. Then, SARS-CoV 2 samples will be collected using viral swabs on different spots, followed by detection and quantification by PCR. Swabbing will be achieved on:

The facial skin, nasal, ocular and oral mucosa of the practitioners.
The protection equipment of the practitioners (FFP2 masks, visors,surgical calot,gloves) .
The environment (dental Chair, surgical light, turbine, contra-angle, on the ground..) The presence of viral loads in areas used by COVID + patients will be evaluated by PCR after swabbing.

The study will provide insight into the risk of SARS-CoV 2 contamination for practitioners performing dental procedures in COVID + patients. This risk will be assessed at the level of the facial skin and oral mucous membranes, which are the doors of entry of the virus.

This study will thus make it possible to assess the protective capacity of the protection protocol implemented in investigators' department in this epidemic situation. This will be assessed depending on whether or not aerosolization is used, its type and the nature of the ventilation in the operating room.

location_facility: service d'odontologie, Hôpital Charles Foix

intervention_type: Procedure


title: Specific Effect of Foot Reflexology on Diaphragm Function: Comparison Between Different Biomarkers Upon Stimulation of the Reflex Area

acronym: FOOT

summary: Diaphragm dysfunction, are refractory to drug therapy. This encourage investigators to explore new non-drug therapeutic paths, such as plantar reflexology (RP). The investigators proposed a comparison of the evolution of different parameters, quantitative and qualitative, to identify biomarkers and highlight the specific effect of RP on the diaphragm function, compared to placebo.

primary_purpose: Other

lead_sponsor: University Hospital, Toulouse

intervention_type: Other


title: Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI (SOUCHY) Brain Changes Due to Hypertension: a Multimodal MRI

acronym: SOUCHY

summary: Investigators propose here to study the brain consequences of hypertension in patients without cognitive complaints and neurological signs. The evaluation of brain suffering requires considering various possible brain damage. The team developed a multimodal MRI approach capable of detecting and quantifying numerous indices (e.g. morphometric, microstructural) to evaluate possible brain suffering. This project aims to identify individually signs of cerebral suffering in hypertensive patients compared to a population of normotensive volunteers, using advanced multiparametric MRI methods.

status: Recruiting

design_allocation: Non-Randomized

primary_purpose: Diagnostic

intervention_type: Diagnostic Test

status_simplified: Ongoing


title: Postoperative Painful Chronicization After Knee Replacement Surgery : Exploratory Study of BDNF's Kinetics

acronym: KNEE BDNF

summary:
Chronic pain is an extremely disabling disease. It is a major public health problem due to the lack of effective therapy.

Chronic postoperative pain (CPOP) is defined by a painful symptomatology in the operated area unrelated to previous pain, present for more than 3 months, and without any link to surgical complication.

The prevalence of chronicization of postoperative pain is 30% after total knee arthroplasty.

Identification of clinical, biological and psychological profiles are crucial to prevent CPOP.

A biologic factor, Brain Derived Neurotrophic Factor (BDNF) produced by a variety of cells is a key regulator of neuroplasticity. BDNF is increasingly studied in the mechanisms of cerebral sensitization and pain chronicization. The role of BDNF in pain of patients remains to be explored in a prospective study. The aim of this observational study is to compare the kinetics of BDNF after total knee arthroplasty in patients with and without CPOP.

Patients will be included in the study at the preanesthetic consultation. Serum BDNF levels will be measured preoperatively, 48h postoperatively, 3 and 6 months after surgery.

status: Active, not recruiting

lead_sponsor: University Hospital, Montpellier

location_facility: Department of Anesthesiology and critical care, Lapeyronie University Hospital


type: Other Identifier

title: Use of "BUBOLight®" Device as an Innovative Phototherapy Device for the Treatment of Newborn's Jaundice. A Monocentric, Descriptive Pilot Study, for the Feasibility, Safety and Tolerance of the BUBOLight® Device

acronym: BUBO

summary:
About 50% of full-term newborns and 80% of premature infants develop jaundice which is due to hyperbilirubinemia. In the majority of cases, jaundice disappears naturally without treatment within three weeks of birth, but the bilirubin level may remain too high, which can lead to a serious neurological disease: kernicterus. To avoid this, a therapeutic management must be instituted, and in some cases, one or more phototherapy sessions (PT) may be prescribed.

The aim of this trial is to evaluate the safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy BUBOLight® included two removable strips of luminous textile incorporating optical fibers.

10 newborns requiring phototherapy, will be illuminated during four hours in one session of PT Bilirubin levels is taken at the start of phototherapy H0 and Controls are made at H+6 hours.

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Lecomte F, Thecua E, Ziane L, Deleporte P, Duhamel A, Vamour C, Mordon S, Rakza T. Phototherapy Using a Light-Emitting Fabric (BUBOLight) Device in the Treatment of Newborn Jaundice: Protocol for an Interventional Feasibility and Safety Study. JMIR Res Protoc. 2021 May 25;10(5):e24808. doi: 10.2196/24808.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: JMIR Publications

lead_sponsor: University Hospital, Lille

intervention_type: Device


title: Qualitative Study of the Experience of Adolescents and Health Professionals Faced With the Necessity for Changing to Remote Care During the COVID-19 Outbreak Quarantine

summary: The Maison des Adolescents (MDA) at Cochin Hospital (Paris) is a multidisciplinary service which welcomes adolescents in three different units: consultation, day care and hospitalization. However, the epidemic of coronavirus (COVID-19) in March 2020 which imposed the extreme limitation of contacts and then the confinement of the entire population, required urgent adaptation of care practices. Teleconsultation quickly became essential for most consultations (psychiatrists, psychologists, nurses, but also pediatricians and somatic physicians). In day hospital, daily reception could not be carried out, therapeutic workshops, family interviews, or speaking groups were organized remotely. In hospital unit, the interruption of visits required the organization of remote interviews with families. Far from the comfort of an organized and structured telepsychiatry, the use of videoconferencing was done in an emergency and without preparation. The objective is to explore the experience of adolescents, doctors and psychologists regarding emergency changes in the methods of their follow-up by setting up teleconsultation in the context of the COVID-19 epidemic.

study_start_date_type: Anticipated

lead_sponsor: Hôpital Cochin


title: Ultrasonographic and MRI Explorations of Infraspinatus Muscle in Postero-superior Rotator Cuff Tear

acronym: VISUMIR

summary: The project aims to evaluate the contribution of texture analysis on MRI sections, and the technical feasibility, reproducibility, and clinical relevance of quantitative ultrasound and elastography to characterize the composition and volume of infraspinatus muscle in postero-superior rotator cuff tears. The perspectives are to optimize the imaging to allow a quantitative, objective and reproducible analysis of the muscle tissue and its characteristics.

lead_sponsor: University Hospital, Tours


title: Impact of a Mobile Geriatric Team With a Pharmacist on the Optimisation of Prescriptions in Elderly Inpatients

acronym: PHARMOG

summary: In patients aged 75 years and older, polypathology is frequent and often associated with polypharmacy. This polypharmacy coupled with a lack of proactive elderly care can sometimes lead to hospitalisation. Due to comorbidities and complex problems, management of geriatric patients usually requires a multidisciplinary approach. In Toulouse University Hospital, elderly inpatients can benefit from a geriatric assessment by a Geriatric Mobile Team. Whether this team improve the prescriptions through the advice of a clinical pharmacist has not been demonstrated yet.

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Pages A, Roland C, Qassemi S, Abdeljalil AB, Houles M, Romain M, Toulza O, Belloc A, McCambridge C, Voisin T, Cestac P, Juillard-Condat B; PharMoG study group. Impact of a Pharmacist-included Mobile Geriatrics team intervention on potentially inappropriate drug prescribing: protocol for a prospective feasibility study (PharMoG study). BMJ Open. 2020 Dec 2;10(12):e040917. doi: 10.1136/bmjopen-2020-040917.


title: Phenotypic and Functional Characterisation of Human B-cell Response in Pemphigus and Application to Other Auto-immune Diseases

acronym: CaReLyBP

summary: Pemphigus is a rare autoimmune disease involving skin and mucous membranes characterized by the production of pathogenic autoantibodies directed against desmosomal transmembrane glycoproteins belonging to the cadherin family,responsible for the disruption of desmosomes leading to the acantholysis phenomenon.Two main classical subtypes of pemphigus have been individualized:pemphigus vulgaris and foliaceus,in which pathogenic autoantibodies are directed against desmoglein 3 and 1 respectively.The knowledge about B-cell populations responsible for pemphigus activity increased a lot.In pemphigus patients,B-cell population was shown to comprise auto-reactive B lymphocytes producing antibodies targeting desmogleins,directly responsible for disease activity,and regulatory B lymphocytes.After rituximab treatment,clinical activity was proved to be associated with circulating auto-antibodies high titers and an increase of auto-reactive B-cells,whereas clinical remission was associated with a change in B-cell populations,as B cell repertoire changed from oligoclonal to polyclonal when reconstituting after treatment,with an increase of immatures and transitional B-cells producing IL-10.The mechanisms leading to autoreactive B-cells appearance,the precise role of B-reg in immune tolerance and the factors triggering the imbalance between pro autoimmune and regulatory immune B-cells leading to pemphigus activity remain to be discovered.Polymorphonuclear neutrophil granulocytes(PMN) are the first responders of the immune system to threats by invading microorganisms.Since 2004, PMN were shown to produce neutrophil extracellular traps(NET),structures consisting of decondensed chromatin embedded with histones,granular and cytoplasmic proteins that trap and kill microbes.In lupus recent works demonstrated evidences that NETs components are found in immune complexes responsible for tissue inflammation and that polyclonal activation of B-cell as well as memory B-cell activation could be obtain in presence of immune complexes derived from NET.Besides lupus,other works showed evidence of NETs implication in inflammatory and auto-immune states in rheumatoid arthritis and small vessel vasculitis.The hypotheses is that B-cell activation by NET might not be restricted to autoimmune diseases of which antibodies target NETs components.The aim is to assess the effects on B-cell activation and the phenotypic changes in B-cell population from pemphigus patients after stimulation by NET.

primary_purpose: Basic Science

ReferenceCitation: Langan SM, Smeeth L, Hubbard R, Fleming KM, Smith CJ, West J. Bullous pemphigoid and pemphigus vulgaris--incidence and mortality in the UK: population based cohort study. BMJ. 2008 Jul 9;337(7662):a180. doi: 10.1136/bmj.a180.

ReferenceCitation: Hashimoto T, Amagai M, Garrod DR, Nishikawa T. Immunofluorescence and immunoblot studies on the reactivity of pemphigus vulgaris and pemphigus foliaceus sera with desmoglein 3 and desmoglein 1. Epithelial Cell Biol. 1995;4(2):63-9.

ReferenceCitation: Martel P, Joly P. Pemphigus: autoimmune diseases of keratinocyte's adhesion molecules. Clin Dermatol. 2001 Nov-Dec;19(6):662-74. doi: 10.1016/s0738-081x(00)00191-7. No abstract available.

ReferenceCitation: Amagai M, Tsunoda K, Zillikens D, Nagai T, Nishikawa T. The clinical phenotype of pemphigus is defined by the anti-desmoglein autoantibody profile. J Am Acad Dermatol. 1999 Feb;40(2 Pt 1):167-70. doi: 10.1016/s0190-9622(99)70183-0.

ReferenceCitation: Mahoney MG, Wang Z, Rothenberger K, Koch PJ, Amagai M, Stanley JR. Explanations for the clinical and microscopic localization of lesions in pemphigus foliaceus and vulgaris. J Clin Invest. 1999 Feb;103(4):461-8. doi: 10.1172/JCI5252.


title: Interaction of HIV/Platelets and HIV-platelets/Lymphocytes in HIV Patients Under cART Treatment But Immunological Non Responders

acronym: PLAQUEVIH

summary:
The investigators propose that the lack of immune response in InR is driven by HIV-containing platelets that might interact with macrophages and CD4+ T-cells although by different mechanisms. In the one hand, HIV-sheltering platelets might fuel tissue HIV macrophage and in turn T cell reservoirs as observed in InRs and/or maintain a low-level viral replication in macrophages, sustaining a persistent inflammatory profile on in these cells. In the other hand,HIV-sheltering platelets might induce CD4+ T-cells dysfunctions via platelets/ectosomes, although without promoting platelet-to-T-cell HIV transfer/infection, thereby increasing the number of peripheral inflammatory TH17 cells and a TH17/Treg unbalance as observed in InRs.

Main Objectives:

i) To characterize and the molecular and functional level the platelet factors implicated in HIV transfer to tissue-like macrophages as well as in the immunomodulatory activity of HIV-containing platelets on macrophages and CD4+ T-cells.

ii) To interrogate the transfer of HIV-containing platelet-derived mRNA and microRNA to tissue-like macrophages and CD4+ T-cells as one major mechanism of target cell immunomodulation.

iii) To investigate the therapeutic potential of anti-platelet aggregation/activation agents (e.g. Abciximab), known to block platelet-immune cell interaction, in improving immune cell functions in vitro and promoting immunological recovery in vivo.

ReferenceCitation: Ganor Y, Real F, Sennepin A, Dutertre CA, Prevedel L, Xu L, Tudor D, Charmeteau B, Couedel-Courteille A, Marion S, Zenak AR, Jourdain JP, Zhou Z, Schmitt A, Capron C, Eugenin EA, Cheynier R, Revol M, Cristofari S, Hosmalin A, Bomsel M. HIV-1 reservoirs in urethral macrophages of patients under suppressive antiretroviral therapy. Nat Microbiol. 2019 Apr;4(4):633-644. doi: 10.1038/s41564-018-0335-z. Epub 2019 Feb 4.

ReferenceCitation: Real F, Sennepin A, Ganor Y, Schmitt A, Bomsel M. Live Imaging of HIV-1 Transfer across T Cell Virological Synapse to Epithelial Cells that Promotes Stromal Macrophage Infection. Cell Rep. 2018 May 8;23(6):1794-1805. doi: 10.1016/j.celrep.2018.04.028.

ReferenceCitation: Kaufmann GR, Perrin L, Pantaleo G, Opravil M, Furrer H, Telenti A, Hirschel B, Ledergerber B, Vernazza P, Bernasconi E, Rickenbach M, Egger M, Battegay M; Swiss HIV Cohort Study Group. CD4 T-lymphocyte recovery in individuals with advanced HIV-1 infection receiving potent antiretroviral therapy for 4 years: the Swiss HIV Cohort Study. Arch Intern Med. 2003 Oct 13;163(18):2187-95. doi: 10.1001/archinte.163.18.2187.

ReferenceCitation: Baker JV, Peng G, Rapkin J, Krason D, Reilly C, Cavert WP, Abrams DI, MacArthur RD, Henry K, Neaton JD; Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). Poor initial CD4+ recovery with antiretroviral therapy prolongs immune depletion and increases risk for AIDS and non-AIDS diseases. J Acquir Immune Defic Syndr. 2008 Aug 15;48(5):541-6. doi: 10.1097/QAI.0b013e31817bebb3.

ReferenceCitation: Kelley CF, Kitchen CM, Hunt PW, Rodriguez B, Hecht FM, Kitahata M, Crane HM, Willig J, Mugavero M, Saag M, Martin JN, Deeks SG. Incomplete peripheral CD4+ cell count restoration in HIV-infected patients receiving long-term antiretroviral treatment. Clin Infect Dis. 2009 Mar 15;48(6):787-94. doi: 10.1086/597093.

ReferenceCitation: Chene G, Sterne JA, May M, Costagliola D, Ledergerber B, Phillips AN, Dabis F, Lundgren J, D'Arminio Monforte A, de Wolf F, Hogg R, Reiss P, Justice A, Leport C, Staszewski S, Gill J, Fatkenheuer G, Egger ME; Antiretroviral Therapy Cohort Collaboration. Prognostic importance of initial response in HIV-1 infected patients starting potent antiretroviral therapy: analysis of prospective studies. Lancet. 2003 Aug 30;362(9385):679-86. doi: 10.1016/s0140-6736(03)14229-8.

ReferenceCitation: Deeks SG, Kitchen CM, Liu L, Guo H, Gascon R, Narvaez AB, Hunt P, Martin JN, Kahn JO, Levy J, McGrath MS, Hecht FM. Immune activation set point during early HIV infection predicts subsequent CD4+ T-cell changes independent of viral load. Blood. 2004 Aug 15;104(4):942-7. doi: 10.1182/blood-2003-09-3333. Epub 2004 Apr 29.

ReferenceCitation: Hunt PW, Martin JN, Sinclair E, Bredt B, Hagos E, Lampiris H, Deeks SG. T cell activation is associated with lower CD4+ T cell gains in human immunodeficiency virus-infected patients with sustained viral suppression during antiretroviral therapy. J Infect Dis. 2003 May 15;187(10):1534-43. doi: 10.1086/374786. Epub 2003 Apr 23.

ReferenceCitation: Marziali M, De Santis W, Carello R, Leti W, Esposito A, Isgro A, Fimiani C, Sirianni MC, Mezzaroma I, Aiuti F. T-cell homeostasis alteration in HIV-1 infected subjects with low CD4 T-cell count despite undetectable virus load during HAART. AIDS. 2006 Oct 24;20(16):2033-41. doi: 10.1097/01.aids.0000247588.69438.fd.

ReferenceCitation: Nunes-Alves C, Nobrega C, Behar SM, Correia-Neves M. Tolerance has its limits: how the thymus copes with infection. Trends Immunol. 2013 Oct;34(10):502-10. doi: 10.1016/j.it.2013.06.004. Epub 2013 Jul 16.

ReferenceCitation: Wilson EM, Singh A, Hullsiek KH, Gibson D, Henry WK, Lichtenstein K, Onen NF, Kojic E, Patel P, Brooks JT, Sereti I, Baker JV; Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy (SUN Study) Investigators. Monocyte-activation phenotypes are associated with biomarkers of inflammation and coagulation in chronic HIV infection. J Infect Dis. 2014 Nov 1;210(9):1396-406. doi: 10.1093/infdis/jiu275. Epub 2014 May 9.

ReferenceCitation: Ballem PJ, Belzberg A, Devine DV, Lyster D, Spruston B, Chambers H, Doubroff P, Mikulash K. Kinetic studies of the mechanism of thrombocytopenia in patients with human immunodeficiency virus infection. N Engl J Med. 1992 Dec 17;327(25):1779-84. doi: 10.1056/NEJM199212173272503.

ReferenceCitation: Grozovsky R, Hoffmeister KM, Falet H. Novel clearance mechanisms of platelets. Curr Opin Hematol. 2010 Nov;17(6):585-9. doi: 10.1097/MOH.0b013e32833e7561.

ReferenceCitation: Hatano H, Hayes TL, Dahl V, Sinclair E, Lee TH, Hoh R, Lampiris H, Hunt PW, Palmer S, McCune JM, Martin JN, Busch MP, Shacklett BL, Deeks SG. A randomized, controlled trial of raltegravir intensification in antiretroviral-treated, HIV-infected patients with a suboptimal CD4+ T cell response. J Infect Dis. 2011 Apr 1;203(7):960-8. doi: 10.1093/infdis/jiq138.

ReferenceCitation: Green SA, Smith M, Hasley RB, Stephany D, Harned A, Nagashima K, Abdullah S, Pittaluga S, Imamichi T, Qin J, Rupert A, Ober A, Lane HC, Catalfamo M. Activated platelet-T-cell conjugates in peripheral blood of patients with HIV infection: coupling coagulation/inflammation and T cells. AIDS. 2015 Jul 17;29(11):1297-308. doi: 10.1097/QAD.0000000000000701.

ReferenceCitation: Starossom SC, Veremeyko T, Yung AW, Dukhinova M, Au C, Lau AY, Weiner HL, Ponomarev ED. Platelets Play Differential Role During the Initiation and Progression of Autoimmune Neuroinflammation. Circ Res. 2015 Oct 9;117(9):779-92. doi: 10.1161/CIRCRESAHA.115.306847. Epub 2015 Aug 20.

ReferenceCitation: Miossec P, Kolls JK. Targeting IL-17 and TH17 cells in chronic inflammation. Nat Rev Drug Discov. 2012 Oct;11(10):763-76. doi: 10.1038/nrd3794.

ReferenceCitation: Rodriguez-Munoz A, Martinez-Hernandez R, Ramos-Levi AM, Serrano-Somavilla A, Gonzalez-Amaro R, Sanchez-Madrid F, de la Fuente H, Marazuela M. Circulating Microvesicles Regulate Treg and Th17 Differentiation in Human Autoimmune Thyroid Disorders. J Clin Endocrinol Metab. 2015 Dec;100(12):E1531-9. doi: 10.1210/jc.2015-3146. Epub 2015 Oct 19.

ReferenceCitation: De Benedetto I, Masetti M, Fabbiani M, Biasin M, Muscatello A, Squillace N, Clerici M, Trabattoni D, Gori A, Bandera A. Higher Levels of Peripheral Th17 T CD4+ Cells Are Associated With Immunological Non Response in HIV-Infected Patients Under Effective ART. J Acquir Immune Defic Syndr. 2018 Apr 15;77(5):e45-e47. doi: 10.1097/QAI.0000000000001627. No abstract available.

ReferenceCitation: Deeks SG. HIV infection, inflammation, immunosenescence, and aging. Annu Rev Med. 2011;62:141-55. doi: 10.1146/annurev-med-042909-093756.

ReferenceCitation: Joosse SA, Pantel K. Tumor-Educated Platelets as Liquid Biopsy in Cancer Patients. Cancer Cell. 2015 Nov 9;28(5):552-554. doi: 10.1016/j.ccell.2015.10.007.

ReferenceCitation: Laffont B, Corduan A, Ple H, Duchez AC, Cloutier N, Boilard E, Provost P. Activated platelets can deliver mRNA regulatory Ago2*microRNA complexes to endothelial cells via microparticles. Blood. 2013 Jul 11;122(2):253-61. doi: 10.1182/blood-2013-03-492801. Epub 2013 May 7.

ReferenceCitation: Risitano A, Beaulieu LM, Vitseva O, Freedman JE. Platelets and platelet-like particles mediate intercellular RNA transfer. Blood. 2012 Jun 28;119(26):6288-95. doi: 10.1182/blood-2011-12-396440. Epub 2012 May 17.

ReferenceCitation: Mann M, Mehta A, Zhao JL, Lee K, Marinov GK, Garcia-Flores Y, Lu LF, Rudensky AY, Baltimore D. An NF-kappaB-microRNA regulatory network tunes macrophage inflammatory responses. Nat Commun. 2017 Oct 11;8(1):851. doi: 10.1038/s41467-017-00972-z. Erratum In: Nat Commun. 2018 Aug 16;9(1):3338.

ReferenceCitation: Rowley JW, Chappaz S, Corduan A, Chong MM, Campbell R, Khoury A, Manne BK, Wurtzel JG, Michael JV, Goldfinger LE, Mumaw MM, Nieman MT, Kile BT, Provost P, Weyrich AS. Dicer1-mediated miRNA processing shapes the mRNA profile and function of murine platelets. Blood. 2016 Apr 7;127(14):1743-51. doi: 10.1182/blood-2015-07-661371. Epub 2016 Jan 14.

ReferenceCitation: Du C, Liu C, Kang J, Zhao G, Ye Z, Huang S, Li Z, Wu Z, Pei G. MicroRNA miR-326 regulates TH-17 differentiation and is associated with the pathogenesis of multiple sclerosis. Nat Immunol. 2009 Dec;10(12):1252-9. doi: 10.1038/ni.1798. Epub 2009 Oct 18. Erratum In: Nat Immunol. 2010 Jun;11(6):543.

ReferenceCitation: Ple H, Landry P, Benham A, Coarfa C, Gunaratne PH, Provost P. The repertoire and features of human platelet microRNAs. PLoS One. 2012;7(12):e50746. doi: 10.1371/journal.pone.0050746. Epub 2012 Dec 4.

ReferenceCitation: Podshivalova K, Salomon DR. MicroRNA regulation of T-lymphocyte immunity: modulation of molecular networks responsible for T-cell activation, differentiation, and development. Crit Rev Immunol. 2013;33(5):435-76. doi: 10.1615/critrevimmunol.2013006858.

ReferenceCitation: Fink L, Holschermann H, Kwapiszewska G, Muyal JP, Lengemann B, Bohle RM, Santoso S. Characterization of platelet-specific mRNA by real-time PCR after laser-assisted microdissection. Thromb Haemost. 2003 Oct;90(4):749-56. doi: 10.1160/TH03-02-0095.

ReferenceCitation: Zhu A, Real F, Zhu J, Greffe S, de Truchis P, Rouveix E, Bomsel M, Capron C. HIV-Sheltering Platelets From Immunological Non-Responders Induce a Dysfunctional Glycolytic CD4+ T-Cell Profile. Front Immunol. 2022 Feb 11;12:781923. doi: 10.3389/fimmu.2021.781923. eCollection 2021.

ReferenceCitation: Real F, Capron C, Sennepin A, Arrigucci R, Zhu A, Sannier G, Zheng J, Xu L, Masse JM, Greffe S, Cazabat M, Donoso M, Delobel P, Izopet J, Eugenin E, Gennaro ML, Rouveix E, Cramer Borde E, Bomsel M. Platelets from HIV-infected individuals on antiretroviral drug therapy with poor CD4+ T cell recovery can harbor replication-competent HIV despite viral suppression. Sci Transl Med. 2020 Mar 18;12(535):eaat6263. doi: 10.1126/scitranslmed.aat6263.

location_facility: Service Hématologie Immunologie, Hôpital Ambroise Paré


title: Characterization of the Subclass of Donor-specific Antibody Determined in Mass Spectrometry as a Risk Factor of Antibody Mediated Rejection in Renal Transplantation

acronym: COR-HUM

summary:
Antibody-mediated rejection is now recognized as the first cause of long-term kidney transplant loss. This type of rejection is mediated by the presence of graft-specific antibodies, usually directed against HLA (Human Leukocyte Antigens), called DSA (Donor Specific Antibody).

De novo DSA (ie, post-transplantation) is detected in approximately 20% of transplant recipients in the first five years, and is a major risk factor for antibody mediated rejection and graft loss.

All anti-HLA antibodies therefore do not have the same pathogenicity. Some teams have shown that the detection of IgG3 anti-HLA by cytometry is associated with a higher risk of humoral rejection but these results have not been confirmed by others. One of the limitations of the cytometry by Luminex technique is that it only informs the detection of each subclass but does not allow analysis of the distribution of the different subclasses of a DSA.

A method has been developed for the relative detection and quantification of different subclasses of the DSA using the mass spectrometry technique and will be tested during this study. This new quantification method therefore opens up the prospect of studying whether, not only the presence but especially the distribution of IgG subclasses, in particular IgG3, could constitute a reliable and robust marker of humoral rejection.

ReferenceType: result

ReferenceCitation: Pernin V, Bec N, Beyze A, Bourgeois A, Szwarc I, Champion C, Chauvin A, Rene C, Mourad G, Merville P, Visentin J, Perrochia H, Couzi L, Larroque C, Le Quintrec M. IgG3 donor-specific antibodies with a proinflammatory glycosylation profile may be associated with the risk of antibody-mediated rejection after kidney transplantation. Am J Transplant. 2022 Mar;22(3):865-875. doi: 10.1111/ajt.16904. Epub 2021 Dec 18.

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Pernin V, Beyze A, Szwarc I, Bec N, Salsac C, Perez-Garcia E, Mourad G, Merville P, Visentin J, Perrochia H, Larroque C, Couzi L, Le Quintrec M. Distribution of de novo Donor-Specific Antibody Subclasses Quantified by Mass Spectrometry: High IgG3 Proportion Is Associated With Antibody-Mediated Rejection Occurrence and Severity. Front Immunol. 2020 Jun 2;11:919. doi: 10.3389/fimmu.2020.00919. eCollection 2020.

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

repository_institution: PubMed Central - Europe PMC

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: Frontiers


title: Angiogenic Function at Normal Term on Placenta

acronym: ANNOTEP

summary: In vivo and ex vivo study of trophoblastic angiogenic trophoblastic function in placentas from normal pregnancies, at term

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Treatment by Anti GP IIb/IIIa in the Setting of a Strategy of Early Coronarography to Patients With an Acute Coronary Syndrome Without ST Elevation

acronym: SISCA

summary:
The acute coronary syndrome (ACS) without ST elevation is a frequent pathology. The main evolutionary risk of these patients is the coronary thrombosis and its self complications. The platelets aggregation plays a major role in the physiopathology of the ACS. The therapeutic arsenal of the anti-thrombosis essentially resting on aspirin and heparin has been reinforced lately by the inhibitors of the glycoprotein anti GP IIb/IIIa. The profit of these products in the ACS with or without ST elevation, associated or not to coronarography, has clearly been demonstrated. This profit is more marked when patients are at high risk of complications. Thus, the use of an anti GP IIb/IIIa is recommended among patients at "high risk" for whom a coronarography is planned, in the last international recommendations of the European Cardiology Society (ESC), the American Heart Association and the American College of Chest Physician. Otherwise, some authors have proposed An early invasive strategy based on coronarography with discordant results. The ideal delay of realization of this coronarography is unknown. It varies according to the studies between 2.5 hours to 48 hours. Once again, patients at high risk seem to benefit the more of such a strategy if it is set precociously.

Objective To compare an invasive strategy associating an early administration of tirofiban and a coronarography achieved in the 6 hours after the randomization to a conservative strategy in a population of high risk patients with ACS without ST elevation.

Design Multicentric, prospective, randomized study.

status: Terminated

lead_sponsor: Hospital Avicenne

intervention_type: Drug


summary: A randomized trial comparing radiotherapy with supportive care in patients aged 70 years or older with newly diagnosed, histologically confirmed anaplastic astrocytoma or glioblastoma, and a Karnofsky performance status > 70.

ReferenceCitation: Keime-Guibert F, Chinot O, Taillandier L, Cartalat-Carel S, Frenay M, Kantor G, Guillamo JS, Jadaud E, Colin P, Bondiau PY, Menei P, Loiseau H, Bernier V, Honnorat J, Barrie M, Mokhtari K, Mazeron JJ, Bissery A, Delattre JY; Association of French-Speaking Neuro-Oncologists. Radiotherapy for glioblastoma in the elderly. N Engl J Med. 2007 Apr 12;356(15):1527-35. doi: 10.1056/NEJMoa065901.


title: MK III Trial: Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine

summary: Hypothesis : Low dose ketamine has an analgesic effect in children with mucositis treated by patient-controlled analgesia with morphine

location_facility: Hôpital Robert Debré Service Pédiatrie-Hémato-immunologie


summary: To assess the potential benefits on mechanical ventilation plateau pressure of pressure controlled mode versus volume controlled mode for laparoscopic bariatric surgery in obese patients (BMI > 35). High plateau pressures encountered in obese patients due to their reduced pulmonary compliance could be lowered using pressure controlled mechanical ventilation.

ReferenceCitation: Frappier J, Guenoun T, Journois D, Philippe H, Aka E, Cadi P, Silleran-Chassany J, Safran D. Airway management using the intubating laryngeal mask airway for the morbidly obese patient. Anesth Analg. 2003 May;96(5):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.


title: Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer (HNPCC) Syndrome: Assessment of Coloscopy With Chromoscopy Benefit

summary: The aim of the study is to test the hypothesis that a chromoscopy colonoscopy is able to increase by 50 % the number of pre-cancer lesions or early cancer detected in patients with HNPCC syndrome, compared to a routine colonoscopy without chromoscopy.

ReferenceCitation: Mention JJ, Ben Ahmed M, Begue B, Barbe U, Verkarre V, Asnafi V, Colombel JF, Cugnenc PH, Ruemmele FM, McIntyre E, Brousse N, Cellier C, Cerf-Bensussan N. Interleukin 15: a key to disrupted intraepithelial lymphocyte homeostasis and lymphomagenesis in celiac disease. Gastroenterology. 2003 Sep;125(3):730-45. doi: 10.1016/s0016-5085(03)01047-3.


title: Management of Resistant Hypertension -Pharmacokinetic Assessment of Different Antihypertensive Regimen -Comparison of Two Treatment Strategies: Increase Sodium Depletion or Combined Blockage of Renin-angiotensin System (RAS)

summary: The purpose of this study is to assess the efficacy of two different treatment regimens for treating resistant hypertension previously uncontrolled with at least 3 antihypertensive treatments. The study hypothesis is that these two regimens (one based on increasing diuretics and the other based on increasing renin angiotensin system blockage) may not differ in terms of efficacy.

ReferenceCitation: Mendes M, Dubourg J, Blanchard A, Bergerot D, Courand PY, Forni V, Frank M, Bobrie G, Menard J, Azizi M. Copeptin is increased in resistant hypertension. J Hypertens. 2016 Dec;34(12):2458-2464. doi: 10.1097/HJH.0000000000001106.

oa_host_type: closed

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Frank M, Peyrard S, Bobrie G, Azizi M. Method of mean value calculation as an additional source of variability in ambulatory blood pressure measurement. Am J Hypertens. 2010 Jul;23(7):725-31. doi: 10.1038/ajh.2010.47. Epub 2010 Mar 25.

location_facility: Investigation Clinical Center European Georges Pompidou Hospital


title: The Strategy Antifungal Empirical Traditional is Again Justified in Prolonged Neutropenias ". Study "PREVERT"

summary: Empirical antifungal treatment is the gold standard for patients who are neutropenic and have persistent fever under broad-spectrum antibiotics. The rational is that fungal infections are difficult to early diagnose, and are life-threatening. Historical trials have shown a small benefit of survival when this strategy is used. According to the drug usde for this strategy, safety and costs may be concerns. However, since this routine practice has been implemented in hematology, new non-invasive biological diagnostic methods are available to early diagnose fungal infections, such as galactomannan antigenemia for aspergillosis. The goal of our study is to show that limiting the administration of antifungals in this setting to patients with clinical foci of infection, or to patients with a positive galactomannan antigenemia reduces the risk of toxicity of the antifungal drug, and has no impact on the overall mortality of patients treated with chemotherapy for hematologic malignancies.

ReferenceCitation: Hughes WT, Armstrong D, Bodey GP, Bow EJ, Brown AE, Calandra T, Feld R, Pizzo PA, Rolston KV, Shenep JL, Young LS. 2002 guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis. 2002 Mar 15;34(6):730-51. doi: 10.1086/339215. Epub 2002 Feb 13. No abstract available.


acronym: MIG-HD

summary: The aim of this study is to assess the clinical benefit of intrastriatal grafting of human cells from the foetal ganglionic eminence in patients with Huntington's disease. The duration of the study will be 52 months. A first group of patients will be grafted at M13-14 (early G group) and a second group of patients will be grafted at M33-34 (late G group). The principal criterion is the comparison of the progression between M12 and M32 of the motor score (TMS) of the UHDRS between grafted patients (early G group) and not yet grafted patients (late G group). An additional evaluation will be performed to compare the progression in individual patients over the 52-month study period. We will thus be able to compare the pre and post-graft TMS progression for all patients.

ReferenceCitation: Bachoud-Levi AC, Remy P, Nguyen JP, Brugieres P, Lefaucheur JP, Bourdet C, Baudic S, Gaura V, Maison P, Haddad B, Boisse MF, Grandmougin T, Jeny R, Bartolomeo P, Dalla Barba G, Degos JD, Lisovoski F, Ergis AM, Pailhous E, Cesaro P, Hantraye P, Peschanski M. Motor and cognitive improvements in patients with Huntington's disease after neural transplantation. Lancet. 2000 Dec 9;356(9246):1975-9. doi: 10.1016/s0140-6736(00)03310-9.

ReferenceCitation: Riad R, Lunven M, Titeux H, Cao XN, Hamet Bagnou J, Lemoine L, Montillot J, Sliwinski A, Youssov K, Cleret de Langavant L, Dupoux E, Bachoud-Levi AC. Predicting clinical scores in Huntington's disease: a lightweight speech test. J Neurol. 2022 Sep;269(9):5008-5021. doi: 10.1007/s00415-022-11148-1. Epub 2022 May 14.

oa_colors: green hybrid

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

version: submittedVersion

publisher_dissemination: Springer-Nature

ReferenceCitation: Bachoud-Levi AC; on behalf the Multicentric Intracerebral Grafting in Huntington's Disease Group. Human Fetal Cell Therapy in Huntington's Disease: A Randomized, Multicenter, Phase II Trial. Mov Disord. 2020 Aug;35(8):1323-1335. doi: 10.1002/mds.28201. Epub 2020 Jul 15.

oa_host_type: repository

repository_institution: Cardiff University - ORCA Online Research @Cardiff

version: acceptedVersion

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Schramm C, Katsahian S, Youssov K, Demonet JF, Krystkowiak P, Supiot F, Verny C, Cleret de Langavant L, Bachoud-Levi AC; European Huntington's Disease Initiative Study Group and the Multicentre Intracerebral Grafting in Huntington's Disease Group. How to Capitalize on the Retest Effect in Future Trials on Huntington's Disease. PLoS One. 2015 Dec 29;10(12):e0145842. doi: 10.1371/journal.pone.0145842. eCollection 2015.

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

repository_institution: Université de Lausanne - SERVAL

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

evidence: oa repository (semantic scholar lookup)

publisher_dissemination: Public Library of Science

ReferenceCitation: Teichmann M, Gaura V, Demonet JF, Supiot F, Delliaux M, Verny C, Renou P, Remy P, Bachoud-Levi AC. Language processing within the striatum: evidence from a PET correlation study in Huntington's disease. Brain. 2008 Apr;131(Pt 4):1046-56. doi: 10.1093/brain/awn036. Epub 2008 Mar 11.

intervention_type: Biological


title: Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis

summary:
The purpose of this study is to evaluate whether carotid angioplasty with stent (CAS) is as safe and effective as carotid surgery in regards to:

the risk of stroke and death within 30 days of the procedure;
the long-term risk of ipsilateral carotid territory stroke, in patients with recently symptomatic, severe carotid stenosis suitable for both CAS and carotid endarterectomy.

ReferenceCitation: Mas JL, Chatellier G, Beyssen B, Branchereau A, Moulin T, Becquemin JP, Larrue V, Lievre M, Leys D, Bonneville JF, Watelet J, Pruvo JP, Albucher JF, Viguier A, Piquet P, Garnier P, Viader F, Touze E, Giroud M, Hosseini H, Pillet JC, Favrole P, Neau JP, Ducrocq X; EVA-3S Investigators. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med. 2006 Oct 19;355(16):1660-71. doi: 10.1056/NEJMoa061752.

ReferenceCitation: Howard VJ, Algra A, Howard G, Bonati LH, de Borst GJ, Bulbulia R, Calvet D, Eckstein HH, Fraedrich G, Greving JP, Halliday A, Hendrikse J, Jansen O, Brown MM, Mas JL, Ringleb PA, Brott TG; Carotid Stenosis Trialists' Collaboration. Absence of Consistent Sex Differences in Outcomes From Symptomatic Carotid Endarterectomy and Stenting Randomized Trials. Stroke. 2021 Jan;52(2):416-423. doi: 10.1161/STROKEAHA.120.030184. Epub 2021 Jan 25.

oa_colors: green other

evidence: open (via free pdf)

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

unpaywall_oa_status: bronze

ReferenceCitation: Muller MD, von Felten S, Algra A, Becquemin JP, Bulbulia R, Calvet D, Eckstein HH, Fraedrich G, Halliday A, Hendrikse J, Howard G, Gregson J, Jansen O, Brown MM, Mas JL, Brott TG, Ringleb PA, Bonati LH. Secular Trends in Procedural Stroke or Death Risks of Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis. Circ Cardiovasc Interv. 2019 Aug;12(8):e007870. doi: 10.1161/CIRCINTERVENTIONS.119.007870. Epub 2019 Aug 5.

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories:
PubMed Central
UCL Discovery
www.zora.uzh.ch

ReferenceCitation: Muller MD, von Felten S, Algra A, Becquemin JP, Brown M, Bulbulia R, Calvet D, Eckstein HH, Fraedrich G, Halliday A, Hendrikse J, Gregson J, Howard G, Jansen O, Mas JL, Brott TG, Ringleb PA, Bonati LH; Carotid Stenosis Trialists' Collaboration. Immediate and Delayed Procedural Stroke or Death in Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis. Stroke. 2018 Nov;49(11):2715-2722. doi: 10.1161/STROKEAHA.118.020684.

ReferenceCitation: Rantner B, Kollerits B, Roubin GS, Ringleb PA, Jansen O, Howard G, Hendrikse J, Halliday A, Gregson J, Eckstein HH, Calvet D, Bulbulia R, Bonati LH, Becquemin JP, Algra A, Brown MM, Mas JL, Brott TG, Fraedrich G; Carotid Stenosis Trialists' Collaboration. Early Endarterectomy Carries a Lower Procedural Risk Than Early Stenting in Patients With Symptomatic Stenosis of the Internal Carotid Artery: Results From 4 Randomized Controlled Trials. Stroke. 2017 Jun;48(6):1580-1587. doi: 10.1161/STROKEAHA.116.016233. Epub 2017 Apr 28.

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

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

ReferenceCitation: Mas JL, Arquizan C, Calvet D, Viguier A, Albucher JF, Piquet P, Garnier P, Viader F, Giroud M, Hosseini H, Hinzelin G, Favrole P, Henon H, Neau JP, Ducrocq X, Padovani R, Milandre L, Rouanet F, Wolff V, Saudeau D, Mahagne MH, Sablot D, Amarenco P, Larrue V, Beyssen B, Leys D, Moulin T, Lievre M, Chatellier G; EVA-3S Investigators. Long-term follow-up study of endarterectomy versus angioplasty in patients with symptomatic severe carotid stenosis trial. Stroke. 2014 Sep;45(9):2750-6. doi: 10.1161/STROKEAHA.114.005671. Epub 2014 Jul 31.

ReferenceCitation: Rantner B, Goebel G, Bonati LH, Ringleb PA, Mas JL, Fraedrich G; Carotid Stenting Trialists' Collaboration. The risk of carotid artery stenting compared with carotid endarterectomy is greatest in patients treated within 7 days of symptoms. J Vasc Surg. 2013 Mar;57(3):619-626.e2; discussion 625-6. doi: 10.1016/j.jvs.2012.08.107. Epub 2012 Dec 11.

ReferenceCitation: Mas JL, Trinquart L, Leys D, Albucher JF, Rousseau H, Viguier A, Bossavy JP, Denis B, Piquet P, Garnier P, Viader F, Touze E, Julia P, Giroud M, Krause D, Hosseini H, Becquemin JP, Hinzelin G, Houdart E, Henon H, Neau JP, Bracard S, Onnient Y, Padovani R, Chatellier G; EVA-3S investigators. Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial. Lancet Neurol. 2008 Oct;7(10):885-92. doi: 10.1016/S1474-4422(08)70195-9. Epub 2008 Sep 5.

location_facility: Sainte-Anne Hospital: Department of Neurology


title: Contribution of a Psycho-Educational Program of Help to Help in the Pharmacological Assumption of Responsibility of the Disease of Alzheimer

summary: The aim of the project is to demonstrate that a psycho-educational programme designed to support and train carers of Alzheimer's disease (AD) patients induces a significantly higher benefit than anticholinesterase drug treatment alone or associated to memantine treatment. This training programme focuses on the explanation/description of behavioral, cognitive and functional disorders induced by the disease, as well as principles of cognitive and psycho-social stimulation of the patients in daily life.

primary_purpose: Health Services Research

ReferenceCitation: Wenisch E, Stoker A, Bourrellis C, Pasquet C, Gauthier E, Corcos E, Banchi MT, De Rotrou J, Rigaud AS. [A global intervention program for institutionalized demented patients]. Rev Neurol (Paris). 2005 Mar;161(3):290-8. doi: 10.1016/s0035-3787(05)85035-0. French.


title: Contrast-Enhanced US of Spleen, Liver and Kidney in Patients With Acute Infection (Malaria and Other Infectious Diseases: a Functional Study

summary:
To evaluate the changes in the microcirculation of the liver, kidney and spleen during acute infection in patients with malaria (cohorts 1 and 3) and other infectious diseases such as acute pyelonephritis at day 0 (within 8 hours of the treatment start), day 2 to 4 and day 28-32, using functional US with continuous infusion of a contrast agent (SonoVue, Bracco, Italy).

Study hypothesis: malaria patients should exhibit a different pattern of enhancement, particularly when quantitative measurements of the SU signals is performed with destruction reperfusion kinetics.

location_facility: Department of Adult Radiology, Necker University Hospital


type: Registry Identifier

title: SIRCUS : Social Information pRocessing in Children:an ocUlo-pupillometric Tool for Standard Evaluation

acronym: SIRCUS

summary: The goal of this observational study is to identify behavioral and physiological markers of social alterations in Autism Spectrum Disorders compared to Typically Developping peers. This single-centre study plan to use eye tracking to evaluate social disorders in Autism Spectrum Disorders (ASD). The investigators will estimate oculometric and pupillometric indices as potential ASD biomarkers. The study will last 4 years and will be organized in two phases.

collaborators: UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.

collaborators: Laboratory of Fundamental and Applied Computer Science of Tours, EA6300

appel_a_projets: PRTS

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

type_etablissement: CHUR

acronyme: SIRCUS

titre: Outil standardisé d'oculo-pupillométrie pour l'évaluation du traitement de l'information sociale chez les enfants

discipline_principale: autre

nom_porteur: BONNET-BRILHAULT

prenom_porteur: Frédérique


title: Assessment of the Determinants of the Thoracic Fluid Content Measured by the Bioimpedance-based Starling System in Critically Ill Patients

acronym: TFC-Bio

summary: The Starling system is a completely non-invasive hemodynamic monitoring technique. It is able to measure the thoracic fluid content (TFC). The TFC is supposed to reflect the total content of fluid in the thorax. Thus, TFC may include two of the variables that are commonly used for hemodynamic monitoring: the extravascular lung water (EVLW), and the global end-diastolic volume (GEDV). However, whether the TFC actually reflects GEDV and EVLW has not been clearly established. The objective of the study is to establish the determinants of TFC among hemodynamic variables including EVLW and GEDV.

lead_sponsor: Bicetre Hospital


title: A Single Center Post-market Clinical Follow-up (PMCF) Observational Study Evaluating the Clinical Performance and the Safety Profile of the JuniOrtho™ Telescopic Intramedullary Nail (JTIN) for the Treatment of Pediatric Patients Suffering From Osteogenesis Imperfecta

acronym: JTIN

summary:
This study has been planned as part of the Orthofix Srl post-market active surveillance plan for the collection of data on both the clinical performance and the safety profile of the JTIN.

The rationale of the proposed study is to update and support the pre-market clinical evaluation of the JTIN with Real World Evidence clinical data in a real-life surgical setting, in order to confirm the benefit/risk ratio of this medical device and to keep the CE mark under Medical Device Regulation (MDR) requirements. One selected site, experienced in the treatment of pediatric patients with OI, where the usage of JTIN is already part of the normal clinical practice, will participate in this study.

status: Not yet recruiting

time_perspective: Retrospective

ReferenceCitation: Azzam KA, Rush ET, Burke BR, Nabower AM, Esposito PW. Mid-term Results of Femoral and Tibial Osteotomies and Fassier-Duval Nailing in Children With Osteogenesis Imperfecta. J Pediatr Orthop. 2018 Jul;38(6):331-336. doi: 10.1097/BPO.0000000000000824.

ReferenceCitation: Birke O, Davies N, Latimer M, Little DG, Bellemore M. Experience with the Fassier-Duval telescopic rod: first 24 consecutive cases with a minimum of 1-year follow-up. J Pediatr Orthop. 2011 Jun;31(4):458-64. doi: 10.1097/BPO.0b013e31821bfb50.

ReferenceCitation: Novacheck TF, Stout JL, Tervo R. Reliability and validity of the Gillette Functional Assessment Questionnaire as an outcome measure in children with walking disabilities. J Pediatr Orthop. 2000 Jan-Feb;20(1):75-81.

lead_sponsor: Orthofix s.r.l.

lead_sponsor_type: industriel


title: Development, Application, and Validation of a Comprehensive Classification Automation System for Allograft Precision Diagnostics in Adult and Pediatric Kidney Transplant Biopsies

summary:
Since 1991, the Banff classification has been the gold standard for defining antibody-mediated rejection (AMR) and T-cell mediated rejection (TCMR), thereby guiding the treatment and management of transplant recipients. Starting from a pure histological approach, the classification has moved over the past three decades towards an integrated precision diagnosis system, which encompasses other expertise, such as immunology, immunogenetic, other basic sciences, biostatistics, data science, and artificial intelligence The counterpart of this constant refinement is that Banff rules are becoming complex to follow, with numerous possible scenarios leading to a high degree of inter-observer variability and misclassifications, which may lead to therapeutic consequences.

The aims of this study are:

To integrate and decode all Banff rules and develop a computer-based application - the Banff Automation System - which provides automated and reproducible diagnoses
To validate the ability of the Banff Automation System to reclassify rejection diagnoses in multicenter cohort studies and clinical trials.

ReferenceCitation: Loupy A, Haas M, Roufosse C, Naesens M, Adam B, Afrouzian M, Akalin E, Alachkar N, Bagnasco S, Becker JU, Cornell LD, Clahsen-van Groningen MC, Demetris AJ, Dragun D, Duong van Huyen JP, Farris AB, Fogo AB, Gibson IW, Glotz D, Gueguen J, Kikic Z, Kozakowski N, Kraus E, Lefaucheur C, Liapis H, Mannon RB, Montgomery RA, Nankivell BJ, Nickeleit V, Nickerson P, Rabant M, Racusen L, Randhawa P, Robin B, Rosales IA, Sapir-Pichhadze R, Schinstock CA, Seron D, Singh HK, Smith RN, Stegall MD, Zeevi A, Solez K, Colvin RB, Mengel M. The Banff 2019 Kidney Meeting Report (I): Updates on and clarification of criteria for T cell- and antibody-mediated rejection. Am J Transplant. 2020 Sep;20(9):2318-2331. doi: 10.1111/ajt.15898. Epub 2020 May 28.

ReferenceCitation: Haas M, Loupy A, Lefaucheur C, Roufosse C, Glotz D, Seron D, Nankivell BJ, Halloran PF, Colvin RB, Akalin E, Alachkar N, Bagnasco S, Bouatou Y, Becker JU, Cornell LD, Duong van Huyen JP, Gibson IW, Kraus ES, Mannon RB, Naesens M, Nickeleit V, Nickerson P, Segev DL, Singh HK, Stegall M, Randhawa P, Racusen L, Solez K, Mengel M. The Banff 2017 Kidney Meeting Report: Revised diagnostic criteria for chronic active T cell-mediated rejection, antibody-mediated rejection, and prospects for integrative endpoints for next-generation clinical trials. Am J Transplant. 2018 Feb;18(2):293-307. doi: 10.1111/ajt.14625. Epub 2018 Jan 21.

ReferenceCitation: Loupy A, Haas M, Solez K, Racusen L, Glotz D, Seron D, Nankivell BJ, Colvin RB, Afrouzian M, Akalin E, Alachkar N, Bagnasco S, Becker JU, Cornell L, Drachenberg C, Dragun D, de Kort H, Gibson IW, Kraus ES, Lefaucheur C, Legendre C, Liapis H, Muthukumar T, Nickeleit V, Orandi B, Park W, Rabant M, Randhawa P, Reed EF, Roufosse C, Seshan SV, Sis B, Singh HK, Schinstock C, Tambur A, Zeevi A, Mengel M. The Banff 2015 Kidney Meeting Report: Current Challenges in Rejection Classification and Prospects for Adopting Molecular Pathology. Am J Transplant. 2017 Jan;17(1):28-41. doi: 10.1111/ajt.14107.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: Imperial College London - Spiral

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

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Mengel M, Loupy A, Haas M, Roufosse C, Naesens M, Akalin E, Clahsen-van Groningen MC, Dagobert J, Demetris AJ, Duong van Huyen JP, Gueguen J, Issa F, Robin B, Rosales I, Von der Thusen JH, Sanchez-Fueyo A, Smith RN, Wood K, Adam B, Colvin RB. Banff 2019 Meeting Report: Molecular diagnostics in solid organ transplantation-Consensus for the Banff Human Organ Transplant (B-HOT) gene panel and open source multicenter validation. Am J Transplant. 2020 Sep;20(9):2305-2317. doi: 10.1111/ajt.16059. Epub 2020 Jun 27.

ReferenceCitation: Haas M, Sis B, Racusen LC, Solez K, Glotz D, Colvin RB, Castro MC, David DS, David-Neto E, Bagnasco SM, Cendales LC, Cornell LD, Demetris AJ, Drachenberg CB, Farver CF, Farris AB 3rd, Gibson IW, Kraus E, Liapis H, Loupy A, Nickeleit V, Randhawa P, Rodriguez ER, Rush D, Smith RN, Tan CD, Wallace WD, Mengel M; Banff meeting report writing committee. Banff 2013 meeting report: inclusion of c4d-negative antibody-mediated rejection and antibody-associated arterial lesions. Am J Transplant. 2014 Feb;14(2):272-83. doi: 10.1111/ajt.12590. Erratum In: Am J Transplant. 2015 Oct;15(10):2784. Rangel, Erika [corrected to Rangel, Erika B].

ReferenceCitation: Mengel M, Sis B, Haas M, Colvin RB, Halloran PF, Racusen LC, Solez K, Cendales L, Demetris AJ, Drachenberg CB, Farver CF, Rodriguez ER, Wallace WD, Glotz D; Banff meeting report writing committee. Banff 2011 Meeting report: new concepts in antibody-mediated rejection. Am J Transplant. 2012 Mar;12(3):563-70. doi: 10.1111/j.1600-6143.2011.03926.x. Epub 2012 Feb 2.

ReferenceCitation: Sis B, Mengel M, Haas M, Colvin RB, Halloran PF, Racusen LC, Solez K, Baldwin WM 3rd, Bracamonte ER, Broecker V, Cosio F, Demetris AJ, Drachenberg C, Einecke G, Gloor J, Glotz D, Kraus E, Legendre C, Liapis H, Mannon RB, Nankivell BJ, Nickeleit V, Papadimitriou JC, Randhawa P, Regele H, Renaudin K, Rodriguez ER, Seron D, Seshan S, Suthanthiran M, Wasowska BA, Zachary A, Zeevi A. Banff '09 meeting report: antibody mediated graft deterioration and implementation of Banff working groups. Am J Transplant. 2010 Mar;10(3):464-71. doi: 10.1111/j.1600-6143.2009.02987.x. Epub 2010 Jan 29.

ReferenceCitation: Solez K, Colvin RB, Racusen LC, Sis B, Halloran PF, Birk PE, Campbell PM, Cascalho M, Collins AB, Demetris AJ, Drachenberg CB, Gibson IW, Grimm PC, Haas M, Lerut E, Liapis H, Mannon RB, Marcus PB, Mengel M, Mihatsch MJ, Nankivell BJ, Nickeleit V, Papadimitriou JC, Platt JL, Randhawa P, Roberts I, Salinas-Madriga L, Salomon DR, Seron D, Sheaff M, Weening JJ. Banff '05 Meeting Report: differential diagnosis of chronic allograft injury and elimination of chronic allograft nephropathy ('CAN'). Am J Transplant. 2007 Mar;7(3):518-26. doi: 10.1111/j.1600-6143.2006.01688.x.

ReferenceCitation: Racusen LC, Halloran PF, Solez K. Banff 2003 meeting report: new diagnostic insights and standards. Am J Transplant. 2004 Oct;4(10):1562-6. doi: 10.1111/j.1600-6143.2004.00585.x.

ReferenceCitation: Solez K, Axelsen RA, Benediktsson H, Burdick JF, Cohen AH, Colvin RB, Croker BP, Droz D, Dunnill MS, Halloran PF, et al. International standardization of criteria for the histologic diagnosis of renal allograft rejection: the Banff working classification of kidney transplant pathology. Kidney Int. 1993 Aug;44(2):411-22. doi: 10.1038/ki.1993.259.

ReferenceCitation: Loupy A, Mengel M, Haas M. Thirty years of the International Banff Classification for Allograft Pathology: the past, present, and future of kidney transplant diagnostics. Kidney Int. 2022 Apr;101(4):678-691. doi: 10.1016/j.kint.2021.11.028. Epub 2021 Dec 17.

ReferenceCitation: Solez K, Colvin RB, Racusen LC, Haas M, Sis B, Mengel M, Halloran PF, Baldwin W, Banfi G, Collins AB, Cosio F, David DS, Drachenberg C, Einecke G, Fogo AB, Gibson IW, Glotz D, Iskandar SS, Kraus E, Lerut E, Mannon RB, Mihatsch M, Nankivell BJ, Nickeleit V, Papadimitriou JC, Randhawa P, Regele H, Renaudin K, Roberts I, Seron D, Smith RN, Valente M. Banff 07 classification of renal allograft pathology: updates and future directions. Am J Transplant. 2008 Apr;8(4):753-60. doi: 10.1111/j.1600-6143.2008.02159.x. Epub 2008 Feb 19.

ReferenceCitation: Racusen LC, Solez K, Colvin RB, Bonsib SM, Castro MC, Cavallo T, Croker BP, Demetris AJ, Drachenberg CB, Fogo AB, Furness P, Gaber LW, Gibson IW, Glotz D, Goldberg JC, Grande J, Halloran PF, Hansen HE, Hartley B, Hayry PJ, Hill CM, Hoffman EO, Hunsicker LG, Lindblad AS, Yamaguchi Y, et al. The Banff 97 working classification of renal allograft pathology. Kidney Int. 1999 Feb;55(2):713-23. doi: 10.1046/j.1523-1755.1999.00299.x.

ReferenceCitation: Racusen LC, Colvin RB, Solez K, Mihatsch MJ, Halloran PF, Campbell PM, Cecka MJ, Cosyns JP, Demetris AJ, Fishbein MC, Fogo A, Furness P, Gibson IW, Glotz D, Hayry P, Hunsickern L, Kashgarian M, Kerman R, Magil AJ, Montgomery R, Morozumi K, Nickeleit V, Randhawa P, Regele H, Seron D, Seshan S, Sund S, Trpkov K. Antibody-mediated rejection criteria - an addition to the Banff 97 classification of renal allograft rejection. Am J Transplant. 2003 Jun;3(6):708-14. doi: 10.1034/j.1600-6143.2003.00072.x.

ReferenceCitation: Solez K, Hansen HE, Kornerup HJ, Madsen S, Sorensen AW, Pedersen EB, Marcussen N, Benediktsson H, Racusen LC, Olsen S. Clinical validation and reproducibility of the Banff schema for renal allograft pathology. Transplant Proc. 1995 Feb;27(1):1009-11. No abstract available.

ReferenceCitation: Solez K, Benediktsson H, Cavallo T, Croker B, Demetris AJ, Drachenberg C, Emancipator S, Furness PN, Gaber LW, Gibson IW, Gough J, Gupta R, Halloran P, Hayry P, Kashgarian M, Marcussen N, Massy ZA, Mihatsch MJ, Morozumi K, Noronha I, Olsen S, Papadimitriou J, Paul LC, Picken M, Racusen LC, Ramos EL, Randhawa P, Rayner DC, Rush D, Sanfilippo F, Taskinen E, Trpkov K, Truong L, Yamaguchi Y, Yilmaz S. Report of the Third Banff Conference on Allograft Pathology (July 20-24, 1995) on classification and lesion scoring in renal allograft pathology. Transplant Proc. 1996 Feb;28(1):441-4. No abstract available.

ipd_sharing_description: The data analyzed during the current study are available from the Principal investigator on reasonable request including standards for General Data Protection Regulation and Institutional Review Board approval.

lead_sponsor: Paris Translational Research Center for Organ Transplantation

location_facility: Paris Translational Centre for Organ Transplantation


title: Longitudinal Cohort Study of Patients With Birdshot Chorioretinopathy.

acronym: CO-BIRD

summary:
The purpose of this study is twofold:

To analyze the clinical features of a cohort of patients with birdshot chorioretinopathy (BCR), an inflammatory bilateral ocular disease, affecting the choroid and the retina.

Various imaging techniques will be used to assess the effect of the disease on the retina and the choroid.

A standardized assessment of the visual function will be performed with visual acuity, visual field and color vision testing. The quality of life of the patients will be evaluated with the VFQ-25 questionnaire.

These analyses will help delineating different forms of the disease among its heterogeneous presentations.

To identify predisposing factors for the disease. The condition is unique from the immunogenetic standpoint by its association with the HLA-A29 allele, which is the strongest link between an HLA class I antigen and a disease. To date, however, the mechanisms leading to birdshot chorioretinopathy remain unknown. GWAS (Genome Wide association Study) based on DNA of the cohort patients will be performed with the aim to identify other susceptibility genes associated with BCR.

ReferenceCitation: Levinson RD, Brezin A, Rothova A, Accorinti M, Holland GN. Research criteria for the diagnosis of birdshot chorioretinopathy: results of an international consensus conference. Am J Ophthalmol. 2006 Jan;141(1):185-7. doi: 10.1016/j.ajo.2005.08.025.

ReferenceCitation: Monnet D, Brezin AP, Holland GN, Yu F, Mahr A, Gordon LK, Levinson RD. Longitudinal cohort study of patients with birdshot chorioretinopathy. I. Baseline clinical characteristics. Am J Ophthalmol. 2006 Jan;141(1):135-42. doi: 10.1016/j.ajo.2005.08.067.

ReferenceCitation: Monnet D, Brezin AP. Birdshot chorioretinopathy. Curr Opin Ophthalmol. 2006 Dec;17(6):545-50. doi: 10.1097/ICU.0b013e3280109479.

ReferenceCitation: Holland GN, Shah KH, Monnet D, Brezin AP, Yu F, Nusinowitz S, Levinson RD. Longitudinal cohort study of patients with birdshot chorioretinopathy II: color vision at baseline. Am J Ophthalmol. 2006 Dec;142(6):1013-8. doi: 10.1016/j.ajo.2006.06.065. Epub 2006 Aug 2.

ReferenceCitation: Monnet D, Levinson RD, Holland GN, Haddad L, Yu F, Brezin AP. Longitudinal cohort study of patients with birdshot chorioretinopathy. III. Macular imaging at baseline. Am J Ophthalmol. 2007 Dec;144(6):818-828. doi: 10.1016/j.ajo.2007.08.011. Epub 2007 Oct 18.

ReferenceCitation: Gordon LK, Monnet D, Holland GN, Brezin AP, Yu F, Levinson RD. Longitudinal cohort study of patients with birdshot chorioretinopathy. IV. Visual field results at baseline. Am J Ophthalmol. 2007 Dec;144(6):829-837. doi: 10.1016/j.ajo.2007.08.010. Epub 2007 Oct 15.

ReferenceCitation: Levinson RD, Du Z, Luo L, Monnet D, Tabary T, Brezin AP, Zhao L, Gjertson DW, Holland GN, Reed EF, Cohen JH, Rajalingam R. Combination of KIR and HLA gene variants augments the risk of developing birdshot chorioretinopathy in HLA-A*29-positive individuals. Genes Immun. 2008 Apr;9(3):249-58. doi: 10.1038/gene.2008.13. Epub 2008 Mar 13.

ReferenceCitation: Kappel PJ, Monnet D, Yu F, Brezin AP, Levinson RD, Holland GN. Contrast sensitivity among patients with birdshot chorioretinopathy. Am J Ophthalmol. 2009 Feb;147(2):351-356.e2. doi: 10.1016/j.ajo.2008.08.021. Epub 2008 Oct 29.

ReferenceCitation: Levinson RD, Monnet D, Yu F, Holland GN, Gutierrez P, Brezin AP. Longitudinal cohort study of patients with birdshot chorioretinopathy. V. Quality of life at baseline. Am J Ophthalmol. 2009 Feb;147(2):346-350.e2. doi: 10.1016/j.ajo.2008.08.011. Epub 2008 Oct 9.

ReferenceCitation: Pagnoux C, Mahr A, Aouba A, Berezne A, Monnet D, Cohen P, Levinson RD, Brezin AP, Guillevin L. Extraocular manifestations of birdshot chorioretinopathy in 118 French patients. Presse Med. 2010 May;39(5):e97-e102. doi: 10.1016/j.lpm.2009.12.005. Epub 2010 Mar 10.

ReferenceCitation: Brezin AP, Monnet D, Cohen JH, Levinson RD. HLA-A29 and birdshot chorioretinopathy. Ocul Immunol Inflamm. 2011 Dec;19(6):397-400. doi: 10.3109/09273948.2011.619295.

ReferenceCitation: Dastiridou AI, Bousquet E, Kuehlewein L, Tepelus T, Monnet D, Salah S, Brezin A, Sadda SR. Choroidal Imaging with Swept-Source Optical Coherence Tomography in Patients with Birdshot Chorioretinopathy: Choroidal Reflectivity and Thickness. Ophthalmology. 2017 Aug;124(8):1186-1195. doi: 10.1016/j.ophtha.2017.03.047. Epub 2017 Apr 26.

ReferenceCitation: Cunningham ET, Levinson RD, Denniston AK, Brezin AP, Zierhut M. Birdshot Chorioretinopathy. Ocul Immunol Inflamm. 2017 Oct;25(5):589-593. doi: 10.1080/09273948.2017.1400800. No abstract available.

ReferenceCitation: Bousquet E, Khandelwal N, Seminel M, Mehanna C, Salah S, Eymard P, Bodin Hassani S, Monnet D, Brezin A, Agrawal R. Choroidal Structural Changes in Patients with Birdshot Chorioretinopathy. Ocul Immunol Inflamm. 2021 Feb 17;29(2):346-351. doi: 10.1080/09273948.2019.1681472. Epub 2019 Nov 12.

ipd_sharing: Yes

ipd_sharing_description: Sharing of anonymized clinical data with other investigators experienced in the care of patients with birdshot chorioretinopathy.


title: Impact of Sport Practice and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects. Physiological Pilot Study

acronym: ASRHACOLS

summary: The study of circulating tumoral DNA makes it possible to study, without invasive procedures or pathological studies, the tumoral DNA circulating in the blood of a patient and its various alterations. In patients with colon-rectal cancer with resected tumor, circulating tumor DNA can be used as a predictive biomarker of metastatic relapse of cancer. However, the routine extension of circulating tumoral DNA remains limited due to several difficulties. One of the pifalls that circulating tumor DNA is greatly diluted by healthy circulating DNA from non-tumor cells. The amount of healthy circulating DNA has been described as being influenced by certain physiological parameters. The aim of the study is to increase knowledge on the influence of physiological factors associated with sports activity and meal on the release kinetics of circulating DNA.

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

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Eurofins Biomnis

location_facility: Assistance Publique Hôpitaux de Paris, Hôpital européen Georges Pompidou


title: Evaluation of the Radiological Dose Delivered to Risky Interventional Cardiology Patients (Optidose)

acronym: Optidose

summary: The purpose of this study is therefore to study the actual doses of X-rays delivered to the patient's skin during recanalization of a coronary artery in a context of Chronic Total Occlusion

lead_sponsor: Ramsay Générale de Santé

sponsor_collaborators:
Ramsay Générale de Santé
European Clinical Trial Experts Network

intervention_type: Radiation


title: Dissociative Disorders in Obesity

acronym: Dissobe

summary: THe aim of this study is to determine the frequency of dissociative tendencies in the obese population treated at the CELIOBE (Liberal Center for Obesity Support) at Hôpital Privé La Louvière among patients consulting for the first time and looking for a medical or surgical course. The DES scale of Carlson and Putman will be used.


title: Study of the Impact of a Social Telepresence Robot on Social Isolation and Loneliness of the Elderly at Home

acronym: DOMIROB

summary: The main purpose of this monocentric, prospective study is to measure the impact of the implementation of a robotic social telepresence tool, during three months at home, on the feeling of loneliness and social isolation of the elderly

ReferenceCitation: Isabet B, Rigaud AS, Li W, Pino M. Telepresence Robot Intervention to Reduce Loneliness and Social Isolation in Older Adults Living at Home (Project DOMIROB): Protocol for a Clinical Nonrandomized Study. JMIR Res Protoc. 2022 Oct 31;11(10):e40528. doi: 10.2196/40528.

lead_sponsor: Gérond'if


title: Impact of Omalizumab Withdrawal After a 3 Year Duration Treatment in Well Controlled Severe Allergic Asthma : a Multicentric Randomized Controlled Trial

acronym: SHORTEN

summary:
The optimal duration of the treatment by OMA remains unclear when asthma is well controlled. Data suggest that a large part of patients with well controlled asthma can discontinue OMA therapy without any asthma control deterioration or with an acceptable decrease in asthma control, therefore French experts propose that omalizumab can be given for "3 to 5 yrs if asthma remains well controlled".

The costs related to OMA are high and frequent injections represent severe constraints for patients. For all these reasons, evaluating whether shortening duration of OMA therapy is feasible while maintaining acceptable asthma control is a critical point. Therefore, the aim of this study is to evaluate asthma control after OMA discontinuation after 33 to 63 months of treatment when asthma is well controlled.

ipd_sharing_description:
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: shorten

titre: Arrêt de l'omalizumab après 3 ans de traitement chez des patients asthmatiques sévères allergiques bien contrôlés : une étude randomisée multicentrique.

discipline_principale: pneumology

nom_porteur: TAILLÉ

prenom_porteur: Camille


title: Survival and Quality of Life After Liver Transplantation in Patients Aged 65 and Over

summary: The main objective of this non-interventional, single-center study is to assess survival and associated factors at 1 year in patients aged 65 and over who received liver transplantation

location_facility: Geriatric Department, Paul Brousse Hospital


type: Other Grant/Funding Number

title: Observational Multicenter Registry to Assess the Enefits of Active Sentry Handpiece During Cataract Surgery With the Centurion Phacoemulsifier (SASCA)

acronym: SASCA

summary:
Each new generation of phacoemulsification system has aimed to optimize the control of fluidics and the delivery of energy during phacoemulsification. Nicoli CM et al., (J Cataract Refract Surg 2016;42:157-162) suggested a better anterior chamber stability when using an active fluidics system. Malik PK et al., (Eye and Vision 2017;4:22) showed that using an IOP based phacoemulsification system in association with the use of an Intrepid balanced tip provides a reduction in CDE (Cumulated Dissipated Energy and EFU (Estimated Fluid Usage). It has also been shown that a lower CDE provides obvious benefits: less endothelium cells damages and lower complication rates (Mady MA et al., Clin.Ophthalmol. 2012; 6:503-10).

The latest technologies, i.e. the Active Sentry Handpiece and Hybrid tips, have been introduced to further improve the safety of phacoemulsification. The Active Sentry system has moved pressure sensors closer to the operated eye, hence further reducing the risk of surge during procedures. (Thorne A et al. Phacoemulsifier occlusion break surge volume reduction, J Cataract Refract Surg. 2018;44:1491-1496). The Hybrid tips have been designed to prevent posterior capsule rupture in the event of contact with the capsule.

This new technology allows phacoemulsification procedures under reduced infusion pressures and a "high-vacuum - low energy" strategy which may lead to a safer procedure.

Data from this study will try to demonstrate that cataract surgeries with Active Sentry will need less CDE and therefore may be safer, due to the surge effects decrease. This CDE parameter will be analysed according to differents subgroups: Presence of hybrid tip or balanced tip, cataract score based on the WHO nuclear grading recommendation (Thylefors B et al., (2002) The WHO Cataract Grading Group, Ophthalmic Epidemiology, 9:2, 83-95) The recent experiences conducted in real world condition in different sites have suggested that Centurion with AS was able to improved settings: maximum vacuum and UltraSound (US) time reduction and as a consequence a 20 to 30% CDE reduction.


title: Study of the Immunological and Virological Response of Patients Infected With SARS-CoV-2 and Presenting an Asymptomatic or Pauci-symptomatic Form

acronym: AMBUCOV

summary:
The purpose of this study is to describe the immunological and virological response of patients infected with CoV-2-SARS and presenting an asymptomatic or mildly symptomatic form, in particular the innate and adaptive response as well as the virological clearance kinetics.

The research hypothesis is that patients with an ambulatory form of SARS-CoV-2 infection, whether asymptomatic or mildly symptomatic, are able to mount an innate and adaptive immunological response capable of rapidly clearing the virus, in contrast to severe forms in which an early deficit of type 1 IFN response has been demonstrated, possibly responsible for a defect in the control of viral replication in the blood.

ReferenceCitation: Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.

evidence: open (via free article)

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: PubMed Central - Europe PMC

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repositories_concat: PubMed Central;repositorio.unal.edu.co

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum In: Lancet Respir Med. 2020 Apr;8(4):e26.

ReferenceCitation: Hadjadj J, Yatim N, Barnabei L, Corneau A, Boussier J, Smith N, Pere H, Charbit B, Bondet V, Chenevier-Gobeaux C, Breillat P, Carlier N, Gauzit R, Morbieu C, Pene F, Marin N, Roche N, Szwebel TA, Merkling SH, Treluyer JM, Veyer D, Mouthon L, Blanc C, Tharaux PL, Rozenberg F, Fischer A, Duffy D, Rieux-Laucat F, Kerneis S, Terrier B. Impaired type I interferon activity and inflammatory responses in severe COVID-19 patients. Science. 2020 Aug 7;369(6504):718-724. doi: 10.1126/science.abc6027. Epub 2020 Jul 13.

ReferenceCitation: Lucas C, Wong P, Klein J, Castro TBR, Silva J, Sundaram M, Ellingson MK, Mao T, Oh JE, Israelow B, Takahashi T, Tokuyama M, Lu P, Venkataraman A, Park A, Mohanty S, Wang H, Wyllie AL, Vogels CBF, Earnest R, Lapidus S, Ott IM, Moore AJ, Muenker MC, Fournier JB, Campbell M, Odio CD, Casanovas-Massana A; Yale IMPACT Team; Herbst R, Shaw AC, Medzhitov R, Schulz WL, Grubaugh ND, Dela Cruz C, Farhadian S, Ko AI, Omer SB, Iwasaki A. Longitudinal analyses reveal immunological misfiring in severe COVID-19. Nature. 2020 Aug;584(7821):463-469. doi: 10.1038/s41586-020-2588-y. Epub 2020 Jul 27.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Fonds IMMUNOV


title: Study of the Robustness Predictive Factors in People Aged Over 75 Years After Going to the Emergency Room

acronym: ROB-U

summary: After emergency room visits, the elderly patients can increase their dependence and functional decline. In this context the goal of this study is to demonstrate that there are robustness predictive factors after visit to the emergency room.

lead_sponsor: Lille Catholic University


title: A Pilot Study of Proprioception Stimulation by Repeated Multi-site Tendon Vibrations, on Upper Limb Motor Skills Recovery After Recent Stroke

acronym: VIBRAMOT

summary:
Stroke is the leading cause of severe acquired disabilities in adults. It can affect sensory and motor functions which are closely entangled. Among them, upper limb function is often strongly impaired. In this study the investigators are interested in the eventuality to improve motor recovery by the mean of stimulating the proprioception.

Proprioception can be stimulated by tendinous vibrations in order to act on the neuromuscular system through the vibratory tonic reflex and by movement illusion.

Stimulation by tendinous vibrations, applied to the musculotendinous endings, has been already proposed in post stroke rehabilitation, but only at late stages. Thus the aim of our study is to observe the effects of repeated tendon vibrations, applied in the early post stroke phase, the effect being measured on the excitability of the motor cortex by the Motor Evoked Potentials and on the motor recovery (motor control and activities).

ReferenceCitation: Reinkensmeyer DJ, Boninger ML. Technologies and combination therapies for enhancing movement training for people with a disability. J Neuroeng Rehabil. 2012 Mar 30;9:17. doi: 10.1186/1743-0003-9-17.

ReferenceCitation: Kitago T, Krakauer JW. Motor learning principles for neurorehabilitation. Handb Clin Neurol. 2013;110:93-103. doi: 10.1016/B978-0-444-52901-5.00008-3.

ReferenceCitation: Nudo RJ, McNeal D. Plasticity of cerebral functions. Handb Clin Neurol. 2013;110:13-21. doi: 10.1016/B978-0-444-52901-5.00002-2.

ReferenceCitation: Edin BB, Johansson N. Skin strain patterns provide kinaesthetic information to the human central nervous system. J Physiol. 1995 Aug 15;487(1):243-51. doi: 10.1113/jphysiol.1995.sp020875.

ReferenceCitation: Hagbarth KE, Eklund G. The muscle vibrator--a useful tool in neurological therapeutic work. Scand J Rehabil Med. 1969;1(1):26-34. No abstract available.

ReferenceCitation: Goodwin GM, McCloskey DI, Matthews PB. Proprioceptive illusions induced by muscle vibration: contribution by muscle spindles to perception? Science. 1972 Mar 24;175(4028):1382-4. doi: 10.1126/science.175.4028.1382.

ReferenceCitation: Roll JP, Vedel JP. Kinaesthetic role of muscle afferents in man, studied by tendon vibration and microneurography. Exp Brain Res. 1982;47(2):177-90. doi: 10.1007/BF00239377.

ReferenceCitation: Roll JP, Albert F, Thyrion C, Ribot-Ciscar E, Bergenheim M, Mattei B. Inducing any virtual two-dimensional movement in humans by applying muscle tendon vibration. J Neurophysiol. 2009 Feb;101(2):816-23. doi: 10.1152/jn.91075.2008. Epub 2008 Dec 3.

ReferenceCitation: Heath CJ, Hore J, Phillips CG. Inputs from low threshold muscle and cutaneous afferents of hand and forearm to areas 3a and 3b of baboon's cerebral cortex. J Physiol. 1976 May;257(1):199-227. doi: 10.1113/jphysiol.1976.sp011364.

ReferenceCitation: Forner-Cordero A, Steyvers M, Levin O, Alaerts K, Swinnen SP. Changes in corticomotor excitability following prolonged muscle tendon vibration. Behav Brain Res. 2008 Jun 26;190(1):41-9. doi: 10.1016/j.bbr.2008.02.019. Epub 2008 Feb 20.

ReferenceCitation: Marconi B, Filippi GM, Koch G, Pecchioli C, Salerno S, Don R, Camerota F, Saraceni VM, Caltagirone C. Long-term effects on motor cortical excitability induced by repeated muscle vibration during contraction in healthy subjects. J Neurol Sci. 2008 Dec 15;275(1-2):51-9. doi: 10.1016/j.jns.2008.07.025. Epub 2008 Aug 29.

ReferenceCitation: Rosenkranz K, Rothwell JC. The effect of sensory input and attention on the sensorimotor organization of the hand area of the human motor cortex. J Physiol. 2004 Nov 15;561(Pt 1):307-20. doi: 10.1113/jphysiol.2004.069328. Epub 2004 Sep 23.

ReferenceCitation: Noma T, Matsumoto S, Shimodozono M, Etoh S, Kawahira K. Anti-spastic effects of the direct application of vibratory stimuli to the spastic muscles of hemiplegic limbs in post-stroke patients: a proof-of-principle study. J Rehabil Med. 2012 Apr;44(4):325-30. doi: 10.2340/16501977-0946.

ReferenceCitation: Celnik P, Hummel F, Harris-Love M, Wolk R, Cohen LG. Somatosensory stimulation enhances the effects of training functional hand tasks in patients with chronic stroke. Arch Phys Med Rehabil. 2007 Nov;88(11):1369-76. doi: 10.1016/j.apmr.2007.08.001.

ReferenceCitation: Liepert J, Binder C. Vibration-induced effects in stroke patients with spastic hemiparesis--a pilot study. Restor Neurol Neurosci. 2010;28(6):729-35. doi: 10.3233/RNN-2010-0541.

ReferenceCitation: Tavernese E, Paoloni M, Mangone M, Mandic V, Sale P, Franceschini M, Santilli V. Segmental muscle vibration improves reaching movement in patients with chronic stroke. A randomized controlled trial. NeuroRehabilitation. 2013;32(3):591-9. doi: 10.3233/NRE-130881.

publisher_dissemination: IOS Press

ReferenceCitation: Marconi B, Filippi GM, Koch G, Giacobbe V, Pecchioli C, Versace V, Camerota F, Saraceni VM, Caltagirone C. Long-term effects on cortical excitability and motor recovery induced by repeated muscle vibration in chronic stroke patients. Neurorehabil Neural Repair. 2011 Jan;25(1):48-60. doi: 10.1177/1545968310376757. Epub 2010 Sep 12.

ReferenceCitation: Conrad MO, Gadhoke B, Scheidt RA, Schmit BD. Effect of Tendon Vibration on Hemiparetic Arm Stability in Unstable Workspaces. PLoS One. 2015 Dec 3;10(12):e0144377. doi: 10.1371/journal.pone.0144377. eCollection 2015.

repository_institution: Marquette University - e-Publications@Marquette

ReferenceCitation: Ribot-Ciscar E, Butler JE, Thomas CK. Facilitation of triceps brachii muscle contraction by tendon vibration after chronic cervical spinal cord injury. J Appl Physiol (1985). 2003 Jun;94(6):2358-67. doi: 10.1152/japplphysiol.00894.2002. Epub 2003 Feb 14.

ReferenceCitation: Kawahira K, Higashihara K, Matsumoto S, Shimodozono M, Etoh S, Tanaka N, Sueyoshi Y. New functional vibratory stimulation device for extremities in patients with stroke. Int J Rehabil Res. 2004 Dec;27(4):335-7. doi: 10.1097/00004356-200412000-00015.

ReferenceCitation: Field-Fote E, Ness LL, Ionno M. Vibration elicits involuntary, step-like behavior in individuals with spinal cord injury. Neurorehabil Neural Repair. 2012 Sep;26(7):861-9. doi: 10.1177/1545968311433603. Epub 2012 Feb 9.

ReferenceCitation: Schindler I, Kerkhoff G, Karnath HO, Keller I, Goldenberg G. Neck muscle vibration induces lasting recovery in spatial neglect. J Neurol Neurosurg Psychiatry. 2002 Oct;73(4):412-9. doi: 10.1136/jnnp.73.4.412.

ReferenceCitation: Kamada K, Shimodozono M, Hamada H, Kawahira K. Effects of 5 minutes of neck-muscle vibration immediately before occupational therapy on unilateral spatial neglect. Disabil Rehabil. 2011;33(23-24):2322-8. doi: 10.3109/09638288.2011.570411. Epub 2011 Apr 12.

ReferenceCitation: Murillo N, Valls-Sole J, Vidal J, Opisso E, Medina J, Kumru H. Focal vibration in neurorehabilitation. Eur J Phys Rehabil Med. 2014 Apr;50(2):231-42.

lead_sponsor: Centre Borelli UMR 9010

sponsor_collaborators:
Centre Borelli UMR 9010
Hopital Lariboisière

location_facility: Physical and Rehabilitation Medicine department of Hôpital Fernand Widal


title: Use of Multispectral Imaging in Digestive Inflammation Diagnosis

acronym: ENDOSPECTRALE

summary:
The study aims as principal objective to show the association between reflectance intensity of mucosa at different wave lengths and

the presence of acute or chronic inflammation in stomach or rectum and normal mucosa;
the presence of glandular atrophy in stomach or intestinal metaplasia.

The secondary objectives are:

to identify reflectance profile which characterize an acute or a chronic inflammation, a glandular atrophy or an intestinal metaplasia, respectively;
to find a correlation between the reflectance to different frequencies and intensity of inflammation according to Sydney Classification in stomach (Dixon M F 1994) and in rectum (Erben U 2014).

location_facility: Service Hépato-Gastroentérologie, Hôpital Ambroise Paré


title: Impact of Bariatric Surgery in Obese Patients With and Without Obstructive Sleep Apnea Syndrome - COLOSS

acronym: COLOSS

summary: It has been shown to date that obesity is associated with increased mortality and that weight loss significantly improves cardiovascular risk factors. Among patients receiving bariatric surgery, 30-90% have moderate to severe obstructive sleep apnea (OSA) syndrome. Given the strong associations between OSA and cardiometabolic comorbidities, this project is based on the hypothesis of a lower improvement of cardiovascular risk factors and a higher number of post-surgical complications in OSAS patients.

sponsor_collaborators:
Ramsay Générale de Santé
Dr CODRON


acronym: AIR

summary:
Primary aim: to demonstrate that stopping antibiotic treatment in patients diagnosed with acute community acquired pneumonia (CAP) based on clinical response has a non-inferior efficacy 15 days after start of treatment, compared to a conventional predetermined duration left to the physician's judgement, in adults treated in the community setting.

Secondary aims: To compare the 2 study arms on:

Clinical success at late follow up (Day 30),
Duration of antibiotic treatment,
Frequency and severity of adverse events,
Patient's pneumonia symptoms and quality of life.

location_facility: Unité des Maladies Infectieuses, CHU Raymond Poincaré

title: A Controlled Randomized, Open Label, Multicenter, Non-inferiority Trial Evaluating an Individualized Antibiotic Duration Treatment Based on Patient Clinical Response, Evaluated Through Connected Devices, for Community Acquired Pneumonia in the Community Setting

type: EudraCT Number

source: euctr

acronyme: AIR

titre: Interruption de l'antibiothérapie des infections respiratoires orientée par la réponse clinique

discipline_principale: médecine générale

nom_porteur: DINH

prenom_porteur: Aurélien


title: A Phase III, Multinational, Multicenter, Investigator-Masked, Randomised, Active-Controlled Trial, Comparing the Efficacy and Safety of DE-130A With Xalatan® in Patients With Open-Angle Glaucoma or Ocular Hypertension

summary: A Phase III, Multinational, Multicenter, Investigator-Masked, Randomised, Active-Controlled Trial, comparing the efficacy and safety of DE-130A with Xalatan® in Patients with Open-Angle Glaucoma or Ocular Hypertension over a 3-Month period, followed by a 12-Month Follow-Up with Open-Label DE-130A Treatment

lead_sponsor: Santen SAS


title: Home-based Cycling Using Connected Ergometric Bicycles for People With Lumbar Spinal Stenosis: a Randomized Controlled Trial

acronym: FLEXCAL

summary: The main objective of the study is to compare the efficacy on back-specific activity limitations at 4 months after-randomisation of home-based cycling using connected ergometric bicycles associated with usual care to usual care.

ReferenceCitation: Nguyen C, Boutron I, Roren A, Baron G, Pauwels C, Lefevre-Colau MM, Poiraudeau S, Dupeyron A, Coudeyre E, Rannou F. Home-based cycling using connected ergometric bicycles for people with lumbar spinal stenosis (FLEXCAL): Protocol for a randomised trial. Ann Phys Rehabil Med. 2021 Mar;64(2):101351. doi: 10.1016/j.rehab.2019.12.006. Epub 2020 Jan 23. No abstract available.

location_facility: Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin

acronyme: FLEXCAL

titre: Programme personnalisé de travail aérobie en cyphose sur vélos ergométriques connectés dans le canal lombaire rétréci : essai randomisé contrôlé pragmatique

discipline_principale: médecine physique et réadaptation

nom_porteur: NGUYEN

prenom_porteur: Christelle


title: Determinant of the Risk of the Becoming Frail in the Non-dependent Elederly

acronym: DEPART

summary: As an active and healthy ageing, "Successful Ageing" is a societal challenge for all countries members according to the European Commission. This study is intended to contribute to increase healthy, active and non-dependent lifetime. To this end the main goal is to highlight clinical and biological frailty determinants in elderly with potential weaknesses.


title: Dose Reduction and Acquisition Parameters Optimization for PEDiatric Digital Radiography

acronym: DRAPOPED

summary: To reduce "As Low As Diagnostically Acceptable" (ALADA) the X ray exposure of pediatric radiology by using a new post treatment processing algorithm (S-Vue, Samsung table GC85A).

location_facility: Service de Radiologie Pédiatrique, C.H.U. Bicêtre, APHP


title: Impact of a Pharmacist's Intervention on Knowledge and Adherence to Biologic Disease-modifying Drugs in Patients With Spondyloarthritis: a Randomised Controlled Trial.

acronym: SPADHESION

summary:
There is a lack of knowledge among patients concerning their treatment with bDMARDs, which could lead to low adherence.

The objective of this study is to assess the impact of a pharmacist's intervention on the adherence to bDMARDs in patients with Spondyloarthritis.

lead_sponsor: Dr Ornella Conort


title: Impacts on Health Outcomes and Resources Utilization of Hospital-at-home for Elderly Patients With Multiple Myeloma

summary:
The study aims to compare the overall survival adjusted to quality of life of 2 groups of patients with multiple myeloma, depending on the type of care: (1) day hospitalization exclusively or (2) day hospitalization combined with hospital-at-home.

As secondary objectives, the study aims to compare the impacts of the two types of care organization on:

the survival of patients and response to treatments according to criteria of the International Myeloma Working Group,
psychological status of patients,
specific toxicity related to treatment used (haematological and infectious toxicity, neurotoxicity, ...),
health outcomes,
the caregiver's burden,

This study is combined with a qualitative study about the incentives and the barriers, and in order to set up the patient's typology.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

appel_a_projets: PREPS

acronyme: PAMM HAD1

titre: Impacts de la prise en charge en Hospitalisation A Domicile des Patients Agés atteints de Myélome multiple sur l'état de santé et l'utilisation des ressources

discipline_principale: organisation des soins

nom_porteur: MITTAINE MARZAC

prenom_porteur: Bénédicte


title: Endocrine and Absorptive Intestinal Function in Patients at Two Years of Bariatric Surgery: Omega Loop Gastric Bypass Versus Roux-en-Y Gastric Bypass

acronym: MINIBHO

summary:
Gastric bypass with omega loop technic (OLGB) seems to be as effective as gastric bypass roux-en-Y (RYGB the reference) for the management of obesity and type 2 diabetes, but with less early surgical complications and more undernutrition in long terms.

This study aims to explore the profile of secretion of entero-insular hormone after a meal test in OLGB patient vs RYGB to understand the mechanisms of the improvement of type 2 diabetes after OLGB.

Secondary objectives are to better understand the absorptive function of the gut after a gastric bypass, to understand why is there more undernutrition in long term after OLGB than after RYGB.

time_perspective: Cross-Sectional

ReferenceCitation: De Bandt D, Rives-Lange C, Frigout Y, Bergerot D, Blanchard A, Le Gall M, Lacorte JM, Chevallier JM, Czernichow S, Poghosyan T, Carette C, Le Beyec J. Similar Gut Hormone Secretions Two Years After One Anastomosis Gastric Bypass and Roux-en-Y Gastric Bypass: a Pilot Study. Obes Surg. 2022 Mar;32(3):757-762. doi: 10.1007/s11695-021-05837-5. Epub 2022 Jan 7.

collaborators: Société Francophone Nutrition Clinique et Métabolisme

location_facility: AP-HP - Hôpital Européen Georges-Pompidou