title: Effect of Tai Chi Protocol on Total Physical Activity in Patients With Rheumatoid Arthritis, in Comparison With a Control Group Without Tai Chi.

acronym: TaiChiRA

summary: The investigator's hypothesis is that tai chi sessions would increase physical activity of patients with Rheumatoid Arthritis. The main objective is to study the effect of tai chi sessions (16 vs.0) on total physical activity of Rheumatoid Arthritis patients, compared to a control group without tai chi.

ReferenceCitation: Biswas A, Oh PI, Faulkner GE, Bajaj RR, Silver MA, Mitchell MS, Alter DA. Sedentary time and its association with risk for disease incidence, mortality, and hospitalization in adults: a systematic review and meta-analysis. Ann Intern Med. 2015 Jan 20;162(2):123-32. doi: 10.7326/M14-1651. Review. Erratum in: Ann Intern Med. 2015 Sep 1;163(5):400.

ReferenceCitation: Cleland CL, Hunter RF, Kee F, Cupples ME, Sallis JF, Tully MA. Validity of the global physical activity questionnaire (GPAQ) in assessing levels and change in moderate-vigorous physical activity and sedentary behaviour. BMC Public Health. 2014 Dec 10;14:1255. doi: 10.1186/1471-2458-14-1255.

ReferenceCitation: Ekelund U, Steene-Johannessen J, Brown WJ, Fagerland MW, Owen N, Powell KE, Bauman A, Lee IM; Lancet Physical Activity Series 2 Executive Committe; Lancet Sedentary Behaviour Working Group. Does physical activity attenuate, or even eliminate, the detrimental association of sitting time with mortality? A harmonised meta-analysis of data from more than 1 million men and women. Lancet. 2016 Sep 24;388(10051):1302-10. doi: 10.1016/S0140-6736(16)30370-1. Epub 2016 Jul 28. Erratum in: Lancet. 2016 Sep 24;388(10051):e6.

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ReferenceCitation: Guidoux R, Duclos M, Fleury G, Lacomme P, Lamaudière N, Manenq PH, Paris L, Ren L, Rousset S. A smartphone-driven methodology for estimating physical activities and energy expenditure in free living conditions. J Biomed Inform. 2014 Dec;52:271-8. doi: 10.1016/j.jbi.2014.07.009. Epub 2014 Jul 15.

ReferenceCitation: Guidoux R, Duclos M, Fleury G, Lacomme P, Lamaudière N, Saboul D, Ren L, Rousset S. The eMouveRecherche application competes with research devices to evaluate energy expenditure, physical activity and still time in free-living conditions. J Biomed Inform. 2017 May;69:128-134. doi: 10.1016/j.jbi.2017.04.005. Epub 2017 Apr 9.

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ReferenceCitation: Uhlig T. Tai Chi and yoga as complementary therapies in rheumatologic conditions. Best Pract Res Clin Rheumatol. 2012 Jun;26(3):387-98. doi: 10.1016/j.berh.2012.05.006. Review.

ReferenceCitation: Veldhuijzen van Zanten JJ, Rouse PC, Hale ED, Ntoumanis N, Metsios GS, Duda JL, Kitas GD. Perceived Barriers, Facilitators and Benefits for Regular Physical Activity and Exercise in Patients with Rheumatoid Arthritis: A Review of the Literature. Sports Med. 2015 Oct;45(10):1401-12. doi: 10.1007/s40279-015-0363-2. Review.

ReferenceCitation: Waite-Jones JM, Hale CA, Lee HY. Psychosocial effects of Tai Chi exercise on people with rheumatoid arthritis. J Clin Nurs. 2013 Nov;22(21-22):3053-61. doi: 10.1111/jocn.12327. Epub 2013 Sep 13.

ReferenceCitation: Wang C. Role of Tai Chi in the treatment of rheumatologic diseases. Curr Rheumatol Rep. 2012 Dec;14(6):598-603. doi: 10.1007/s11926-012-0294-y. Review.

ReferenceCitation: Wang C. Tai Chi improves pain and functional status in adults with rheumatoid arthritis: results of a pilot single-blinded randomized controlled trial. Med Sport Sci. 2008;52:218-229. doi: 10.1159/000134302.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Prevention and Pharmacological Management of Cardiac Adverse Drug Reactions Induced by Drugs Used in Oncology. The PICARO Cohort

acronym: PICARO

summary:
Recently, the medical management of cancer patients has considerably improved the prognosis of these patients and today some cancers are becoming "chronic diseases". As a result, new adverse effects (AEs) are observed, particularly cardiac.

These "new" cardiac AEs are the consequence of a significant increase in patients life expectancy (delayed AEs not previously seen) but also the use of new pharmacological classes of anticancer drugs such as kinase inhibitors. The incidence of these cardiac AEs varies according to the patient profile and the anticancer molecules used, but their impact on the morbidity and mortality of the patients is significant.

In this context, we started at the University Hospital of Caen Normandy in September 2017 a cardio-oncology program entitled "prevention and pharmacological management of cardiac adverse effects induced by drugs used in Oncology" (PICARO program). This program involves the pharmacology department (opening of a dedicated consultation), the cardiology department (opening of a dedicated ultrasound consultation), vascular medicine departement (opening of a dedicated consultation) and the oncology federation. This program aims to be regional in the future. We therefore propose to build a cohort backed up to the PICARO program to assess the regional impact of cardiac AEs of anticancer drugs and thus to be better able to specify the number of AEs, the incidence and regional prevalence of these drugs. .

The constitution of this cohort is only the first step towards the constitution in the near future (2 years) of an observatory and then a regional registry of cardiac AEs induced by anticancer drugs. The objectives associated with the establishment of such a registry would be to reduce the number of cardiac AEs, the hospitalizations caused by these AEs, a better information of health professionals and patients, an improvement in the screening of patients at risk, all coming back in the context of health, clinical, epidemiological and pharmacological surveillance.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Dolladille C, Ederhy S, Allouche S, Dupas Q, Gervais R, Madelaine J, Sassier M, Plane AF, Comoz F, Cohen AA, Thuny FR, Cautela J, Alexandre J. Late cardiac adverse events in patients with cancer treated with immune checkpoint inhibitors. J Immunother Cancer. 2020 Jan;8(1). pii: e000261. doi: 10.1136/jitc-2019-000261.

family: Dolladille

full_name: Charles Dolladille

given: Charles

sequence: first

family: Ederhy

full_name: Stephane Ederhy

given: Stephane

sequence: additional

family: Allouche

full_name: Stéphane Allouche

given: Stéphane

family: Dupas

full_name: Querntin Dupas

given: Querntin

family: Gervais

full_name: Radj Gervais

given: Radj

family: Madelaine

full_name: Jeannick Madelaine

given: Jeannick

family: Sassier

full_name: Marion Sassier

given: Marion

family: Plane

full_name: Anne-Flore Plane

given: Anne-Flore

family: Comoz

full_name: Francois Comoz

given: Francois

family: Cohen

full_name: Ariel Aron Cohen

given: Ariel Aron

family: Thuny

full_name: Franck Roland Thuny

given: Franck Roland

family: Cautela

full_name: Jennifer Cautela

given: Jennifer

family: Alexandre

full_name: Joachim Alexandre

given: Joachim

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal for ImmunoTherapy of Cancer

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal


type: Other Identifier

title: Efficacy of Testosterone Gel to Restore Normal Serum Values of Testosterone During the Acute Phase of Critical Illness in Adult ICU Patients

acronym: TestICUs

summary:
Critically ill patients experience major insults that lead to increased protein catabolism. Hypermetabolism occurs early and rapidly during the first week of critical illness to provide amino acids for the production of energy via gluconeogenesis, and also for the synthesis of acute phase proteins and repair of tissue damage. During acute phase, neuroendocrine and inflammatory responses promote protein breakdown and amino acid release. Under stress conditions, protein synthesis cannot match the increased rate of muscle proteolysis because of a state of anabolism resistance, which limits uptake of amino acids into muscles. Hypermetabolism results in a significant loss of lean body mass with an impact on weaning from the ventilator and muscle recovery. Functional disability may be long term sometimes with no full return to normal.

In critically ill patients, severe and persistent testosterone deficiency is very common and is observed early after ICU admission. This acquired hypogonadism promotes the persistent loss of skeletal muscle protein and is related to poor outcome.

Administration of testosterone induces skeletal muscle fiber hypertrophy, decreases protein breakdown in healthy young men and burned patients. It has been repeatedly shown that testosterone treatment enhances muscle mass and strength in young and older hypogonadal men and women and can improve physical performance.

study_start_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

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family: Levine

full_name: Sanford Levine

given: Sanford

family: Nguyen

full_name: Taitan Nguyen

given: Taitan

family: Taylor

full_name: Nyali Taylor

given: Nyali

family: Friscia

full_name: Michael E. Friscia

given: Michael E.

family: Budak

full_name: Murat T. Budak

given: Murat T.

family: Rothenberg

full_name: Pamela Rothenberg

given: Pamela

family: Zhu

full_name: Jianliang Zhu

given: Jianliang

family: Sachdeva

full_name: Rajeev Sachdeva

given: Rajeev

family: Sonnad

full_name: Seema Sonnad

given: Seema

family: Kaiser

full_name: Larry R. Kaiser

given: Larry R.

family: Rubinstein

full_name: Neal A. Rubinstein

given: Neal A.

family: Powers

full_name: Scott K. Powers

given: Scott K.

family: Shrager

full_name: Joseph B. Shrager

given: Joseph B.

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Rapid Disuse Atrophy of Diaphragm Fibers in Mechanically Ventilated Humans

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ReferenceCitation: Vigen R, O'Donnell CI, Barón AE, Grunwald GK, Maddox TM, Bradley SM, Barqawi A, Woning G, Wierman ME, Plomondon ME, Rumsfeld JS, Ho PM. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 2013 Nov 6;310(17):1829-36. doi: 10.1001/jama.2013.280386. Erratum in: JAMA. 2014 Mar 5;311(9):967.

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ReferenceCitation: Snyder PJ, Bhasin S, Cunningham GR, Matsumoto AM, Stephens-Shields AJ, Cauley JA, Gill TM, Barrett-Connor E, Swerdloff RS, Wang C, Ensrud KE, Lewis CE, Farrar JT, Cella D, Rosen RC, Pahor M, Crandall JP, Molitch ME, Cifelli D, Dougar D, Fluharty L, Resnick SM, Storer TW, Anton S, Basaria S, Diem SJ, Hou X, Mohler ER 3rd, Parsons JK, Wenger NK, Zeldow B, Landis JR, Ellenberg SS; Testosterone Trials Investigators. Effects of Testosterone Treatment in Older Men. N Engl J Med. 2016 Feb 18;374(7):611-24. doi: 10.1056/NEJMoa1506119.

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title: Study of the Benefit of Early Treatment With an Endothelin Inhibitor (Bosentan) in Patients With Sudden Blindness Due to Giant Cell Arteritis: CECIBO

acronym: CECIBO

summary:
Giant cell arteritis , also named Horton's disease, is the most common vasculitis in subjects over 50 years old. The incidence increases with age : from 188 to 290 cases per million inhabitants per year, with a North-South gradient.

The major risk of Horton's disease is blindness, unilateral, occurring in 15 to 20% of cases, sometimes preceded by episodes of transient amaurosis. The decrease in visual acuity is often brutal, irreversible and bilateral in 25 to 50% of cases. The mechanism of this blindness is an arterial ischemia: Acute Anterior Ischemic Optic Neuropathy acute anterior ischaemic optic neuropathy (90%), acute retro-bulbar ischaemic optic neuropathy (5%), occlusion of the central artery of the retina (5%).

The pathogenesis of this brutal ischemia is not fully understood. One of the hypotheses suggests that, during stimulation by an antigen of the environment, preactivated dendritic cells of the arterial wall would stimulate T lymphocytes. These will recruit cells that cause an inflammatory infiltrate polymorphic predominant at the media level. These lesions may be accompanied by destruction of the internal elastic lamina, with inconstant but pathognomonic presence of multinucleated giant cells. All arteries with internal elastic lamina can be affected by parietal inflammation, which results in stenosis and occlusion, explaining the ischemia.

The visual loss is usually abrupt and very severe, leaving the patient with definitely very low or no residual visual acuity.

Conventional treatment currently recommended includes systemic corticosteroid therapy at 1 mg / kg / day, preceded or not by 500 mg pulses of methylprednisolone , and associated with antiplatelet and anticoagulant therapy (LMWH). Despite the decline in visual acuity thus occurred is then always final. Certainly loss of vision has a major impact on the quality of life of patients.

Apart from this lymphocytic inflammation, a process of vascular remodeling is at the origin of the vascular occlusion phenomenon. The endothelin system is a family of amino acids including 3 members: ET1, ET2 and ET3. ET1 is a potent vasoconstrictor. ET1 receptors (ETA and ETB) are expressed in the arteries of patients with giant cell arteritis . The expression of ET1 associated with proliferation of muscle cells in arteries will decrease under the effect of endothelin inhibitors. This has been shown during treatment of pulmonary hypertension. In giant cell arteritis , the endothelin system continues to be very active up to 8 days despite the introduction of systemic corticosteroids. Bosentan is a mixed endothelin receptor antagonist with affinity for both ETA and ETB receptors. This inhibitor is used in treatment of pulmonary artery hypertension, digital ulcerations of systemic sclerosis and critical peripheral arterial ischemia.

ReferenceCitation: Chaigne-Delalande S, de Menthon M, Lazaro E, Mahr A. [Giant-cell arteritis and Takayasu arteritis: epidemiological, diagnostic and treatment aspects]. Presse Med. 2012 Oct;41(10):955-65. doi: 10.1016/j.lpm.2012.07.011. Epub 2012 Aug 31. Review. French.

ReferenceCitation: Watelet B, Samson M, de Boysson H, Bienvenu B. Treatment of giant-cell arteritis, a literature review. Mod Rheumatol. 2017 Sep;27(5):747-754. doi: 10.1080/14397595.2016.1266070. Epub 2017 Jan 13. Review.

ReferenceCitation: Salvarani C, Cantini F, Hunder GG. Polymyalgia rheumatica and giant-cell arteritis. Lancet. 2008 Jul 19;372(9634):234-45. doi: 10.1016/S0140-6736(08)61077-6. Review.

ReferenceCitation: González-Gay MA, García-Porrúa C, Llorca J, Hajeer AH, Brañas F, Dababneh A, González-Louzao C, Rodriguez-Gil E, Rodríguez-Ledo P, Ollier WE. Visual manifestations of giant cell arteritis. Trends and clinical spectrum in 161 patients. Medicine (Baltimore). 2000 Sep;79(5):283-92.

ReferenceCitation: Weyand CM, Goronzy JJ. Medium- and large-vessel vasculitis. N Engl J Med. 2003 Jul 10;349(2):160-9. Review.

ReferenceCitation: Bienvenu B, Ly KH, Lambert M, Agard C, André M, Benhamou Y, Bonnotte B, de Boysson H, Espitia O, Fau G, Fauchais AL, Galateau-Sallé F, Haroche J, Héron E, Lapébie FX, Liozon E, Luong Nguyen LB, Magnant J, Manrique A, Matt M, de Menthon M, Mouthon L, Puéchal X, Pugnet G, Quemeneur T, Régent A, Saadoun D, Samson M, Sène D, Smets P, Yelnik C, Sailler L, Mahr A; Groupe d'Étude Français des Artérites des gros Vaisseaux, under the Aegis of the Filière des Maladies Auto-Immunes et Auto-Inflammatoires Rares. Management of giant cell arteritis: Recommendations of the French Study Group for Large Vessel Vasculitis (GEFA). Rev Med Interne. 2016 Mar;37(3):154-65. doi: 10.1016/j.revmed.2015.12.015. Epub 2016 Jan 29.

ReferenceCitation: Weyand CM, Schönberger J, Oppitz U, Hunder NN, Hicok KC, Goronzy JJ. Distinct vascular lesions in giant cell arteritis share identical T cell clonotypes. J Exp Med. 1994 Mar 1;179(3):951-60.

ReferenceCitation: Terrades-Garcia N, Cid MC. Pathogenesis of giant-cell arteritis: how targeted therapies are influencing our understanding of the mechanisms involved. Rheumatology (Oxford). 2018 Feb 1;57(suppl_2):ii51-ii62. doi: 10.1093/rheumatology/kex423. Review.

ReferenceCitation: Lozano E, Segarra M, Corbera-Bellalta M, García-Martínez A, Espígol-Frigolé G, Plà-Campo A, Hernández-Rodríguez J, Cid MC. Increased expression of the endothelin system in arterial lesions from patients with giant-cell arteritis: association between elevated plasma endothelin levels and the development of ischaemic events. Ann Rheum Dis. 2010 Feb;69(2):434-42. doi: 10.1136/ard.2008.105692. Epub 2009 Mar 15.

ReferenceCitation: Dimitrijevic I, Andersson C, Rissler P, Edvinsson L. Increased tissue endothelin-1 and endothelin-B receptor expression in temporal arteries from patients with giant cell arteritis. Ophthalmology. 2010 Mar;117(3):628-36. doi: 10.1016/j.ophtha.2009.07.043. Epub 2009 Dec 24.

ReferenceCitation: Planas-Rigol E, Terrades-Garcia N, Corbera-Bellalta M, Lozano E, Alba MA, Segarra M, Espígol-Frigolé G, Prieto-González S, Hernández-Rodríguez J, Preciado S, Lavilla R, Cid MC. Endothelin-1 promotes vascular smooth muscle cell migration across the artery wall: a mechanism contributing to vascular remodelling and intimal hyperplasia in giant-cell arteritis. Ann Rheum Dis. 2017 Sep;76(9):1624-1634. doi: 10.1136/annrheumdis-2016-210792. Epub 2017 Jun 12.

ReferenceCitation: Régent A, Ly KH, Groh M, Khifer C, Lofek S, Clary G, Chafey P, Baud V, Broussard C, Federici C, Labrousse F, Mesturoux L, Le Jeunne C, Vidal E, Brezin A, Witko-Sarsat V, Guillevin L, Mouthon L. Molecular analysis of vascular smooth muscle cells from patients with giant cell arteritis: Targeting endothelin-1 receptor to control proliferation. Autoimmun Rev. 2017 Apr;16(4):398-406. doi: 10.1016/j.autrev.2017.02.006. Epub 2017 Feb 14. Review.

ReferenceCitation: Matucci-Cerinic M, Denton CP, Furst DE, Mayes MD, Hsu VM, Carpentier P, Wigley FM, Black CM, Fessler BJ, Merkel PA, Pope JE, Sweiss NJ, Doyle MK, Hellmich B, Medsger TA Jr, Morganti A, Kramer F, Korn JH, Seibold JR. Bosentan treatment of digital ulcers related to systemic sclerosis: results from the RAPIDS-2 randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2011 Jan;70(1):32-8. doi: 10.1136/ard.2010.130658. Epub 2010 Aug 30.

ReferenceCitation: Narváez J, García-Gómez C, Álvarez L, Santo P, Aparicio M, Pascual M, López de Recalde M, Borrell H, Nolla JM. Efficacy of bosentan in patients with refractory thromboangiitis obliterans (Buerger disease): A case series and review of the literature. Medicine (Baltimore). 2016 Nov;95(48):e5511. doi: 10.1097/MD.0000000000005511. Review.

ReferenceType: result

ReferenceCitation: Ly KH, Liozon E, Fauchais AL, Vidal E. [Pathophysiology of giant cell arteritis]. Rev Med Interne. 2013 Jul;34(7):392-402. doi: 10.1016/j.revmed.2013.02.037. Epub 2013 Mar 23. Review. French.

family: Ly

full_name: K.-H. Ly

family: Liozon

full_name: E. Liozon

given: E.

family: Fauchais

full_name: A.-L. Fauchais

family: Vidal

full_name: E. Vidal

journal_name: La Revue de Médecine Interne

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Physiopathologie de l’artérite à cellules géantes

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


title: Evaluation of the Interest of the Neurorrhaphy in the Resensitisation of Free Flaps in Maxillofacial Reconstructive Surgery. Randomized Prospective Study.

summary:
The surgical procedure consists in removing a tumor of the oral cavity and then repairing the oral defect by the use of a free flap. A free flap is tissue composed of skin and aponeurosis taken from the thigh or forearm, or tissue composed of bone taken from the leg to fill in tissue loss. This tissue is vascularized by a vein and an artery that are removed with the flap to ensure its survival. Investigator would also like to harvest the nerve involved in the sensitivity of the skin flap to suture it to a nerve which will be located near the reconstructed area, and this to enhance sensitivity of the reconstructed oral cavity. Thanks to this, investigator also wish to highlight that this resensitization would improve the patient's quality of life particularly regarding his major oral functions (swallowing, phonation, sensation of cold and hot felt, chewing).

Investigator therefore seek to demonstrate that suturing the nerve will give to the patient the ability back to feel tactile and thermal sensations This is the purpose of the study.

status: Recruiting

intervention_type: Procedure

status_simplified: Ongoing


title: Determinants of the Recovery of Diaphragm Dysfunction in Patients With Prolonged Mechanical Ventilation

acronym: DD-SRPR

summary: The transition to unassisted breathing after invasive ventilation often proves challenging. Persistent ventilator dependence predisposes patients to nosocomial complications and death and increases the economic burden of critical illness. Ventilator-dependence results from an imbalance between the load and capacity of the respiratory muscle pump. Patients who fail a trial of spontaneous breathing commonly exhibit excess respiratory loads secondary to weaning-induced pulmonary edema, atelectasis or dynamic hyperinflation. At the same time, many ventilator-dependent patients exhibit striking loss of respiratory pump capacity due to diaphragm dysfunction which predisposes to prolonged ventilator dependence. Diaphragm dysfunction is common in ventilated patients. By prolonging ventilator dependence it may be an important contributor to the poor long-term clinical and functional outcomes of survivors of critical illness. While some main risk factors for diaphragm dysfunction have been already described (diaphragm disuse induced by mechanical ventilation, sepsis, initial severity upon admission), the determinants of recovery of diaphragm dysfunction are unknown, as well it has not been elucidated whether diaphragm function can simply improve after the acute phase of ICU admission. Therefore, the goal of this study is to investigate the time course evolution of diaphragm function in patients exposed to prolonged duration of mechanical ventilation (i.e. in a weaning center) and to determine which factors are associated with an improvement of the diaphragm function leading to a safe mechanical ventilation discontinuation.

primary_purpose: Diagnostic

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Device


title: Effect of Argentine Tango Protocol on Total Physical Activity in Patients With Chronic Inflammatory Arthritis

acronym: IATANGO

summary: The hypothesis is that pleasure brought by argentine tango practice would increase total physical activity of patients with chronic inflammatory arthritis.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceCitation: Biswas A, Oh PI, Faulkner GE, Bajaj RR, Silver MA, Mitchell MS, Alter DA. Sedentary time and its association with risk for disease incidence, mortality, and hospitalization in adults: a systematic review and meta-analysis. Ann Intern Med. 2015 Jan 20;162(2):123-32. doi: 10.7326/M14-1651. Review. Erratum in: Ann Intern Med. 2015 Sep 1;163(5):400.

ReferenceCitation: Sokka T, Häkkinen A. Poor physical fitness and performance as predictors of mortality in normal populations and patients with rheumatic and other diseases. Clin Exp Rheumatol. 2008 Sep-Oct;26(5 Suppl 51):S14-20. Review.

ReferenceCitation: Garner S, Fenton T, Martin L, Creaser C, Johns C, Barnabe C. Personalized diet and exercise recommendations in early rheumatoid arthritis: A feasibility trial. Musculoskeletal Care. 2018 Mar;16(1):167-172. doi: 10.1002/msc.1214. Epub 2017 Oct 2.

ReferenceCitation: van der Heijde D, Ramiro S, Landewé R, Baraliakos X, Van den Bosch F, Sepriano A, Regel A, Ciurea A, Dagfinrud H, Dougados M, van Gaalen F, Géher P, van der Horst-Bruinsma I, Inman RD, Jongkees M, Kiltz U, Kvien TK, Machado PM, Marzo-Ortega H, Molto A, Navarro-Compàn V, Ozgocmen S, Pimentel-Santos FM, Reveille J, Rudwaleit M, Sieper J, Sampaio-Barros P, Wiek D, Braun J. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017 Jun;76(6):978-991. doi: 10.1136/annrheumdis-2016-210770. Epub 2017 Jan 13. Review.

ReferenceCitation: Wendling D, Lukas C, Prati C, Claudepierre P, Gossec L, Goupille P, Hudry C, Miceli-Richard C, Molto A, Pham T, Saraux A, Dougados M. 2018 update of French Society for Rheumatology (SFR) recommendations about the everyday management of patients with spondyloarthritis. Joint Bone Spine. 2018 May;85(3):275-284. doi: 10.1016/j.jbspin.2018.01.006. Epub 2018 Mar 8. Review.

ReferenceCitation: Veldhuijzen van Zanten JJ, Rouse PC, Hale ED, Ntoumanis N, Metsios GS, Duda JL, Kitas GD. Perceived Barriers, Facilitators and Benefits for Regular Physical Activity and Exercise in Patients with Rheumatoid Arthritis: A Review of the Literature. Sports Med. 2015 Oct;45(10):1401-12. doi: 10.1007/s40279-015-0363-2. Review.

ReferenceCitation: Fongen C, Sveaas SH, Dagfinrud H. Barriers and Facilitators for Being Physically Active in Patients with Ankylosing Spondylitis: A Cross-sectional Comparative Study. Musculoskeletal Care. 2015 Jun;13(2):76-83. doi: 10.1002/msc.1088. Epub 2014 Nov 5.

ReferenceCitation: Larkin L, Gallagher S, Fraser A, Kennedy N. Community-based intervention to promote physical activity in rheumatoid arthritis (CIPPA-RA): a study protocol for a pilot randomised control trial. Rheumatol Int. 2017 Dec;37(12):2095-2103. doi: 10.1007/s00296-017-3850-y. Epub 2017 Oct 17.

ReferenceCitation: Lötzke D, Ostermann T, Büssing A. Argentine tango in Parkinson disease--a systematic review and meta-analysis. BMC Neurol. 2015 Nov 5;15:226. doi: 10.1186/s12883-015-0484-0. Review.

ReferenceCitation: Cleland CL, Hunter RF, Kee F, Cupples ME, Sallis JF, Tully MA. Validity of the global physical activity questionnaire (GPAQ) in assessing levels and change in moderate-vigorous physical activity and sedentary behaviour. BMC Public Health. 2014 Dec 10;14:1255. doi: 10.1186/1471-2458-14-1255.

intervention_type: Other

status_simplified: Completed


acronym: Phase 1

summary: Overview of response rate published in recent oncology phase I trials

time_perspective: Retrospective

ReferenceCitation: Chakiba C, Grellety T, Bellera C, Italiano A. Encouraging Trends in Modern Phase 1 Oncology Trials. N Engl J Med. 2018 Jun 7;378(23):2242-2243. doi: 10.1056/NEJMc1803837.

family: Chakiba

full_name: Camille Chakiba

given: Camille

family: Grellety

full_name: Thomas Grellety

given: Thomas

family: Bellera

full_name: Carine Bellera

given: Carine

family: Italiano

full_name: Antoine Italiano

given: Antoine

lead_sponsor: Institut Bergonié

lead_sponsor_type: industriel


title: International Consensus Process to Provide Guidelines for the Definition of Efficacy Endpoints to Assess Treatment Efficacy in Randomized Controlled Trials in Elderly Cancer Patients

acronym: DATECANelderly

summary:
Context and hypothesis: In cancer randomized controlled trials (RCT), the validated and most objective criterion to assess treatment efficacy is overall survival (OS). In the elderly population, OS presents limitations as it can be affected by factors other than treatment such as comorbidity or severe toxicity. Although mortality reduction is important for patients of all ages, alternative outcomes such as the ability to live independently or with a better quality of life, may be more important for older patients.

Reviews of RCT have highlighted (i) the heterogeneity of such alternative efficacy outcomes and (ii) an absence of standardized definitions for these endpoints. As a result, this may limit the quality of RCT as well as the comparison of results across trials. Our objective is to provide guidelines for standardized definitions of such alternative endpoints to assess treatment efficacy in cancer RCT in elderly populations.

The development of guidelines will follow a formal consensus method (questionnaires + in-person meetings). A large panel of international experts will participate.

Guidelines are awaited due to the heterogeneity of endpoints and absence of standardized definitions. Standardizing definitions will improve the quality and design of future trials and enhance comparison between trials.

status: Active, not recruiting


title: Impact of Biological Point of Care Devices Implementation on the Length of Stay of Patients in Emergency Room

acronym: SUPOC

summary:
"Main objective: to demonstrate that the implementation of an extended panel solution for the point of care analysis of biological parameters (point of care : POC) in an emergency department (ED) reduces the length of stay (LOS) of patients Secondary objectives: to demonstrate the feasibility of implementing an expanded panel of POC solutions in an ED and the reduction of emergency overcrowding in the POC group.

To determine the medico-economic impact of the extended implementation of POC solutions (cost-efficiency and health-economic study), to collect the satisfaction of medical (emergency physicians, medical biologists) and paramedical personnel as well as the satisfaction of patients.

Inclusion criteria: Any patient consulting in the emergency department during the study period Non-inclusion criteria: Patients attending the emergency departments as part of dressing or trauma follow-up consultations Main criteria of judgment: Time between administrative registration and the patient's discharge or hospitalization decision, compared between the control period and the intervention period (POC).

Design: Prospective, monocentric, controlled, cluster- randomized per week. Duration of center preparation (technical preparation and training of laboratory staff): 4 weeks Duration of inclusion period: 18 weeks Duration of patient participation: 1 day Total trial duration time: 22 weeks"

ReferenceCitation: Hausfater P, Hajage D, Bulsei J, Canavaggio P, Lafourcade A, Paquet AL, Arock M, Durand-Zaleski I, Riou B, Oueidat N. Impact of Point-of-care Testing on Length of Stay of Patients in the Emergency Department: A Cluster-randomized Controlled Study. Acad Emerg Med. 2020 Oct;27(10):974-983. doi: 10.1111/acem.14072. Epub 2020 Jul 27.

name: From the Emergency DepartmentHôpital Pitié‐SalpêtrièreAPHP ParisFrance

name: the UMR INSERM 1166 IHU ICAN Sorbonne Université, GRC‐14 BIOSFAST ParisFrance

family: Hausfater

full_name: Pierre Hausfater

given: Pierre

name: the Département Biostatistique Santé Publique et Information Médicale Centre de Pharmacoépidémiologie (Cephepi) Sorbonne UniversitéAPHP ParisFrance

family: Hajage

full_name: David Hajage

given: David

name: the AP‐HP URC Eco Ile de France Hôpital de l'Hôtel Dieu ParisFrance

name: the CRESS INSERM INRA Université de Paris ParisFrance

family: Bulsei

full_name: Julie Bulsei

given: Julie

family: Canavaggio

full_name: Pauline Canavaggio

given: Pauline

name: the Unité de Recherche Clinique Salpêtrière–Charles Foix APHP ParisFrance

family: Lafourcade

full_name: Alexandre Lafourcade

given: Alexandre

family: Paquet

full_name: Anne Laure Paquet

given: Anne Laure

name: and the Biochemisty and Emergency Biology Department Hôpital Pitié‐SalpêtrièreAPHP Paris France

family: Arock

full_name: Michel Arock

given: Michel

family: Durand‐Zaleski

full_name: Isabelle Durand‐Zaleski

given: Isabelle

family: Riou

full_name: Bruno Riou

given: Bruno

family: Oueidat

full_name: Nathalie Oueidat

given: Nathalie

journal_name: Academic Emergency Medicine

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Impact of Point‐of‐care Testing on Length of Stay of Patients in the Emergency Department: A Cluster‐randomized Controlled Study


title: Status of Superficial Esophageal Cancers Treated by Endoscopy

acronym: OESOFARE

summary:
In 2013, esophageal cancer was the 9th cause of cancer in the world and the 6th in terms of cancer mortality. The prognosis of this cancer varies according to geographical areas, but in Europe and the USA, the 5-year survival rate has risen from less than 5% in the 1960s to around 20% in the 2000s. In the United States, however, the survival rate has risen from 5% in the 1960s to around 20% in the 2000s.

Increased the detection of premalignant lesions and early stages may improve prognosis. The presence of esophageal cancer is determined by endoscopy, biopsy and histological confirmation. However, endoscopic techniques (mucosectomy and sub mucosal dissection) are also used as curative treatment for early esophageal lesions.

Now, due to the low number of diagnoses of esophageal tumours at the superficial stage, few studies are available in Europe on the efficacy of these endoscopic techniques and on the complications resulting from their use. Similarly, little is known about the complications of endoscopic techniques and about therapeutic strategies for managing these superficial lesions. In particular, no data are available concerning the adequacy between the treatment proposed in multidisciplinary consultation meetings and the actual management of patients.

Our study is therefore fundamental to make an inventory of superficial esophageal cancers treated by endoscopy, and their management

lead_sponsor: Nantes University Hospital


title: COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure (COLONIA)

acronym: COLONIA

summary:
Chronic Compartment Syndrome (CCS) is a pathology that affects more specifically subjects exposed to repeated movements, particularly in a professional life or sports. The diagnosis is difficult and often delayed.

Currently, the reference technique is invasive. It consists of measuring by a intramuscular puncture (IMP) pressure in the offending compartment early after effort (usually between 1 and 5 minutes post-exercise). A value greater than or equal to 30 mmHg in the first 5 minutes is used as a diagnostic criterion for CCS.

Other less invasive techniques (scintigraphy) exist but are subject to certain discordances of interpretation. The advent of new assessment tools, like the MyotonPRO, pave the way for a non-invasive diagnostic approach.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Angers

intervention_type: Diagnostic Test


title: Impairment of the Cognitive Flow in the Development of a Depressive Disorder and Suicidal Ideas

acronym: AQUARIUM

summary: The study consists in estimating the mental load (cognitive saturation) and the production of driving cognition to suicidal patients.

lead_sponsor: Centre Hospitalier René Dubos

intervention_type: Behavioral


title: Efficacy of Hypnoanalgesia by a Radiological Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology

acronym: HYP-ANGE

summary:
This study highlights the global management of the various components of outpatient pain by hypnoanalgesia (pain management by hypnosis) in radiopediatrics.

Indeed, pain is induced by sclerosis of cutaneous angiomas in interventional radiology. It is managed by MEOPA (an equimolar mixture of oxygen nitrous oxide) or by general anesthesia.

For four years, the medical electroradiology technologist of the Mother and Child Hospital (HFME) of the Hospices Civils de Lyon offer patients in addition a pain management by hypnoanalgesia.

The investigator propose a multicenter open randomized study comparing two pain management strategies, in children aged 7 to 18 years treated for cutaneous angioma by sclerosis in interventional radiology at the HFME. The two strategies studied are: Hypnoanalgesia and MEOPA (the reference strategy).

The main objective is to evaluate the efficacy of hypnoanalgesia compared to the standard of care of pain, which is the use of MEOPA, in the treatment of sclerosis of cutaneous angioma in pediatric interventional radiology.

status: Not yet recruiting

lead_sponsor: Hospices Civils de Lyon


title: Impact on Performance of the Use of a Digital Cognitive Aid in Simulated Crisis and Stress Situations

summary:
The previous investigators' studies (MAX, Lelaidier et al, BJA 2017, & SIMMAXMARCHERYAN) clearly showed that the use of a digital cognitive aid in the hand of the leader significantly improves the management of anaesthesia and intensive care emergencies as well as basic combat casualty care.

The present study exclusively deals with the advanced management of simulated combat casualties by military doctors and nurses using the same digital cognitive aid adapted for MARCHE RYAN algorithm.

lead_sponsor: CEJKA Jean-Christophe


title: Cognitive Control Training in Online Problem Gambling: an Online Randomized Controlled Trial Among Non-treatment Seeking Problem Gamblers

acronym: TRAIN-ONLINE

summary: An online single blinding, randomized, comparative therapeutic web-based, controlled trial. The main objective of the study is to assess the clinical efficacy of an online computerized cognitive training program targeted on cognitive control, namely on inhibition, measured with the PGSI-recent, a modified version of Problem Gambling Severity Index (PGSI) with a 30 days recall period in patients with problem gambling, at 6 weeks, as compared to a control program with a similar setting.

ReferenceCitation: Santiago A, Carré A, Miranda R, Lemogne C, LeStrat Y, Benyamina A, Perney P, Luquiens A. Study protocol for an online randomised controlled trial among non-treatment seeking problem gamblers: training inhibition in online problem gambling (TRAIN-online) trial. BMJ Open. 2021 Nov 30;11(11):e051641. doi: 10.1136/bmjopen-2021-051641.

family: Santiago

full_name: Antoine Santiago

family: Carré

full_name: Arnaud Carré

given: Arnaud

family: Miranda

full_name: Ruben Miranda

given: Ruben

family: Lemogne

full_name: Cédric Lemogne

given: Cédric

family: LeStrat

full_name: Yann LeStrat

given: Yann

family: Benyamina

full_name: Amine Benyamina

given: Amine

family: Perney

full_name: Pascal Perney

given: Pascal

family: Luquiens

full_name: Amandine Luquiens

given: Amandine

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_host_type: publisher

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal


title: Prognostic Value of Cardiac Output Measured by Impedancemetry in Patients Monitored for Pulmonary Hypertension

acronym: HPepic

summary: Monocentric cohort study, prospective, evaluating the variability of cardiac output measurement by resting and stress impedancemetry as a prognostic factor for Pulmonary Hypertension

primary_purpose: Prevention

lead_sponsor: University Hospital, Toulouse


ipd_sharing_description: All IPD that underlie results in a publication

lead_sponsor: Regeneron Pharmaceuticals

ipd_sharing: Yes

type: EudraCT Number

source: euctr

title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study in Cat-Allergic Patients With Asthma to Evaluate the Efficacy of a Single Dose of REGN1908-1909 to Reduce Bronchoconstriction Upon Cat Allergen Challenge

summary:
The primary objective is to evaluate the prophylactic efficacy of REGN1908-1909 (anti-Fel d 1) administered as a single dose on day 1 in cat-allergic asthmatic patients not living with a cat in the prevention of a Controlled Cat Allergen Challenge-induced early asthmatic response (EAR) assessed by measures of lung function (FEV1) compared to placebo-treated patients.

Secondary Efficacy Objectives:

To evaluate the prophylactic efficacy of REGN1908-1909 administered as a single dose on day 1 in cat-allergic asthmatic patients not living with a cat, in the prevention of a Controlled Cat Allergen Challenge-induced: Allergic rhinitis and Ocular symptoms
To evaluate the prophylactic efficacy of REGN1908-1909 administered as a single dose on day 1 in cat-allergic asthmatic patients not living with a cat to increase the exposure to cat allergen, measured as a product of minute ventilation and time, required to induce EAR in a Controlled Cat Allergen Challenge as compared to placebo patients

Secondary Safety Objective:

To evaluate the safety and tolerability of REGN1908-1909 vs. placebo in patients with cat allergen-triggered asthma


title: Non-inferiority of Virtual Reality Compared to Other Forms of Optokinetic Stimulation in the Rehabilitation of Vestibular Syndromes. Randomized Controlled Trial.

acronym: EquiRV

summary:
Context and justification: Vertigo leads to medical consultation, interruption of daily activities or work stoppage in 80% of cases. Optokinetic stimulation is used in awareness and adaptation exercises. The technology of three-dimensional head-mounted provides a strong immersion allowing optokinetic stimulation but studies interested in virtual reality in the context of balance rehabilitation have not been able to highlight the superiority of this therapy. The investigators therefore propose a non-inferiority trial because of the affordable price and small size of three-dimensional head-mounted.

Objectives : The objective of this study is to evaluate whether a rehabilitation program using virtual reality is as effective as a reference program using Smart Equitest and an optokinetic stimulator to improve the balance of patients with vestibular syndrome after 3 or 4 weeks of rehabilitation.

The investigators also assess the disability related to vertigo and balance disorders as well as the tolerance of virtual reality Methodology: Prospective, randomized controlled non-inferiority trial, monocentric, 2 parallel arm, with blind assessed after 3 or 4 weeks of follow-up.

The inclusion criteria are the pathologies eligible for a vestibular rehabilitation program and the possible standing position.

The criteria for non-inclusion are visually impaired or blind subjects, lack of relief vision, history of epilepsy, significant strabismus, permanent bilateral vestibular areflexes and Ménière's disease.

The main evaluation criterion is the balance score obtained with eyes closed on an unstable plane during a sensory organization test performed on a dynamic posturology platform, obtained during the final evaluation.

The secondary judgment criteria are:

The balance scores obtained in the sensory organization test under other conditions.
The Dizziness Handicap Inventory obtained during the final evaluation and three months after the end of the program.
The tolerance of virtual reality will be measured weekly by the Simulator Sickness Questionnaire.

Statistics: The number of subjects to be included is 76, the analysis will first be performed per-protocol, the difference in scores between the two groups will be calculated, as well as its 95% confidence interval. If the lower bound of this interval is above the non-inferiority threshold, the same analysis will be performed on the population intending to treat (all randomized patients).

Process: Recruitment and rehabilitation take place at the CH Coste Floret. The duration of inclusions is 27 months, The duration of patient participation in the protocol is 4 months. Patients are cared for 21 or 28 days with two sessions of physiotherapy per day, five days a week, then resolved by telephone 3 months after the rehabilitation Feasibility: CH Coste Floret has the human and material resources necessary to carry out the protocol. The PMSI data show that the department receives about 40 patients per year who are likely to participate in the protocol.

Outcomes / perspectives: In the event of a result validating the non-inferiority of virtual reality, this study could provide further evidence of the value of this type of tool for the rehabilitation of subjects suffering from vestibular disorders. In addition, a medico-economic study would be possible in order to reinforce the advantages of virtual reality helmets.

lead_sponsor: University Hospital, Montpellier

location_facility: CH Paul Coste Floret/ Pavillon Jeanne d'Arc/ Leroy


title: Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication

acronym: MRIMOP

summary: Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume. Current techniques involve partial or total coverage of the implant with the pectoralis major muscle, to prevent exposure or infection. The muscle dissection technique applied has functional and cosmetic consequences. In this study, an endoscopic approach will be evaluated. This new surgical technique, using a single-port endoscopic way, will put the scar is in the axillary area, away from the breast. The hypothesis is that this delocalized scar potentially reduces the risk of exposure and allows placement of the implant in the subcutaneous space, with no manipulation of the pectoralis major muscle.


title: French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator

summary: National french registry of patients with tetralogy of Fallot and implantable cardioverter defibrillator.

ReferenceCitation: Bessière F, Gardey K, Bouzeman A, Duthoit G, Koutbi L, Labombarda F, Marquié C, Gourraud JB, Mondoly P, Sellal JM, Bordachar P, Hermida A, Anselme F, Asselin A, Audinet C, Bernard Y, Boveda S, Chevalier P, Clerici G, da Costa A, de Guillebon M, Defaye P, Eschalier R, Garcia R, Guenancia C, Guy-Moyat B, Henaine R, Irles D, Iserin L, Jourda F, Ladouceur M, Lagrange P, Laredo M, Mansourati J, Massoulié G, Mathiron A, Maury P, Nguyen C, Ninni S, Perier MC, Pierre B, Sacher F, Walton C, Winum P, Martins R, Pasquié JL, Thambo JB, Jouven X, Combes N, Di Filippo S, Marijon E, Waldmann V. Impact of Pulmonary Valve Replacement on Ventricular Arrhythmias in Patients With Tetralogy of Fallot and Implantable Cardioverter-Defibrillator. JACC Clin Electrophysiol. 2021 Oct;7(10):1285-1293. doi: 10.1016/j.jacep.2021.02.022. Epub 2021 Apr 28.

family: Bessière

full_name: Francis Bessière

given: Francis

family: Gardey

full_name: Kévin Gardey

given: Kévin

family: Bouzeman

full_name: Abdeslam Bouzeman

given: Abdeslam

family: Duthoit

full_name: Guillaume Duthoit

given: Guillaume

family: Koutbi

full_name: Linda Koutbi

given: Linda

family: Labombarda

full_name: Fabien Labombarda

given: Fabien

family: Marquié

full_name: Christelle Marquié

given: Christelle

family: Gourraud

full_name: Jean Baptiste Gourraud

given: Jean Baptiste

family: Mondoly

full_name: Pierre Mondoly

given: Pierre

family: Sellal

full_name: Jean Marc Sellal

given: Jean Marc

family: Bordachar

full_name: Pierre Bordachar

family: Hermida

full_name: Alexis Hermida

given: Alexis

family: Anselme

full_name: Frédéric Anselme

given: Frédéric

family: Asselin

full_name: Anouk Asselin

given: Anouk

family: Audinet

full_name: Caroline Audinet

given: Caroline

family: Bernard

full_name: Yvette Bernard

given: Yvette

family: Boveda

full_name: Serge Boveda

given: Serge

family: Chevalier

full_name: Philippe Chevalier

given: Philippe

family: Clerici

full_name: Gael Clerici

given: Gael

family: da Costa

full_name: Antoine da Costa

given: Antoine

family: de Guillebon

full_name: Maxime de Guillebon

given: Maxime

family: Defaye

full_name: Pascal Defaye

family: Eschalier

full_name: Romain Eschalier

given: Romain

family: Garcia

ReferenceCitation: Waldmann V, Bouzeman A, Duthoit G, Koutbi L, Bessiere F, Labombarda F, Marquié C, Gourraud JB, Mondoly P, Sellal JM, Bordachar P, Hermida A, Anselme F, Asselin A, Audinet C, Bernard Y, Boveda S, Bru P, Bun SS, Clerici G, Da Costa A, de Guillebon M, Defaye P, Elbaz N, Eschalier R, Garcia R, Guenancia C, Guy-Moyat B, Halimi F, Irles D, Iserin L, Jourda F, Ladouceur M, Lagrange P, Laredo M, Mansourati J, Massoulié G, Mathiron A, Maury P, Messali A, Narayanan K, Nguyen C, Ninni S, Perier MC, Pierre B, Pujadas P, Sacher F, Sagnol P, Sharifzadehgan A, Walton C, Winum P, Zakine C, Fauchier L, Martins R, Pasquié JL, Thambo JB, Jouven X, Combes N, Marijon E; DAI-T4F Investigators*. Long-Term Follow-Up of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator: The DAI-T4F Nationwide Registry. Circulation. 2020 Oct 27;142(17):1612-1622. doi: 10.1161/CIRCULATIONAHA.120.046745. Epub 2020 Oct 1.

name: Université de Paris, Institut National de la Santé et de la Recherche Médicale, Paris Cardiovascular Research Centre, France (V.W., A.A., S.B., M. Ladouceur, K.N., M.-C.P., A.S., X.J., E.M.).

name: Adult Congenital Heart Disease Medico-Surgical Unit (V.W., L.I., M. Ladouceur), European Georges Pompidou Hospital, Paris, France.

name: Cardiac Electrophysiology Unit (V.W., A.S., X.J., E.M.), European Georges Pompidou Hospital, Paris, France.

name: Parly II Private Hospital, Le Chesnay, France (A.B., F.H.).

name: La Pitié-Salpêtrière University Hospital, Paris, France (G.D., M. Laredo).

name: La Timone Hospital, Marseille, France (L.K.).

name: Louis Pradel Hospital, Lyon, France (F.B., C.W.).

name: Caen University Hospital, France (F.L.).

name: Lille University Hospital, France (C.M., S.N.).

name: Nantes University Hospital, France (J.B.G.).

name: Toulouse University Hospital, France (P. Mondoly, P. Maury).

name: Nancy University Hospital, France (J.M.S.).

name: Bordeaux University Hospital, France (P. Bordachar, F.S., J.B.T.).

name: LIRYC Institute, Université de Bordeaux, France (P. Bordachar).

name: Amiens University Hospital, France (A.H., A. Mathiron).

name: Rouen University Hospital, France (F.A.).

name: Bretagne Sud Hospital, Lorient, France (C.A.).

name: Besançon University Hospital, France (Y.B.).

name: Brussel University (VUB), Belgium (S.B).

name: Pasteur Clinic, Toulouse, France (S.B., N.C.).

name: Pasteur Nice University Hospital, France (S.S.B.).

name: Saint Pierre University Hospital, La Réunion, France (G.C.).

name: Saint Etienne University Hospital, France (A.D.C.).

name: Grenoble University Hospital, France (P.D.).

name: Henri-Mondor University Hospital, Créteil, France (N.E.).

name: Cardiology Department, CHU Clermont-Ferrand, France (R.E., G.M.).

name: Université Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA Clermont, Institut Pascal, F-63000 Clermont-Ferrand, France (R.E.).

name: Poitiers University Hospital, France (R.G.).

name: Dijon University Hospital, France (C.G.).

name: Limoges University Hospital, France (B.G.-M.).

name: Saint-Pierre Clinic, Perpignan, France (P.L.).

name: Brest University Hospital, France (J.M.).

name: Bichat University Hospital, Paris, France (A. Messali).

name: Chalon sur Saône Hospital, France (C.N., P.S.).

name: Tours University Hospital, France (B.P., L.F.).

name: Les Franciscaines Clinic, Nîmes, France (P.P.).

name: Nîmes University Hospital, France (P.W.).

name: Saint-Gatien Clinic, Tours, France (C.Z.).

name: Rennes University Hospital, France (R.M.).

name: CHU de Montpellier and CNRS UMR9214 – Inserm U1046 – PHYMEDEXP, Montpellier, France (J.L.P.).

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

publisher: Ovid Technologies (Wolters Kluwer Health)


title: Stratégie Transfusionnelle érythrocytaire Dans la réanimation du Choc Septique du Patient d'Onco-hématologie : Essai randomisé Multicentrique TRANSPORT [TRANSfusion in Patients With Onco-hematological Malignancies ResusciTated From Septic Shock]

acronym: TRANSPORT

summary:
Septic shock is a frequent complication associated with high mortality in patients with malignancies. The best transfusion strategy (restrictive or liberal) for the resuscitation of septic shock remains a controversial issue, in relation with potentially discrepant goals of tissue oxygenation and transfusion sparing.

In this study, the investigators propose to address the efficacy of two RBC transfusion strategies (liberal or restrictive) in restoring appropriate tissue oxygenation as well as their tolerance.

The investigators designed a prospective randomized multicenter trial aimed at comparing liberal and restrictive RBC transfusion strategies applied during the first 48 hours of resuscitation in cancer patients with septic shock and anemia.

intervention_type: Biological


title: Evaluation of the Efficiency of Lina LibrataTM System in the Treatment of Functional Idiopathic Menometrorrhagia

acronym: THERMOLIB

summary:
Menometrorrhagia is the first cause of consultation in gynecology. Etiology of menometrorrhagia is varied, but in majority of cases no underlying pathology is found, they are said functional idiopathic menometrorrhagia .

In case of failure of medical treatment, for women who do not wish to preserve reproduction possibilities, a surgical treatment by endometrectomy (destruction of the uterine endometrial epithelial) can be proposed. Currently, a new system, Lina LibrataTM is available on the market. This system allows destructing endometrial membrane with a balloon which offer several advantages compared to present used system. Specially, it does not require dilatation of uterus's cervix and it reduces the pain. The investigator make hypothesis that the use of the system Lina LibrataTM does not cause pain and can be thus used under local anesthetic in ambulatory surgery. With the aim of developing ambulatory care, the main objective of this prospective monocentric study is to estimate the efficiency of Lina LibrataTM system in the treatment of functional idiopathic menometrorrhagia. Secondary objectives are to estimate the pain during the procedure, the rate of per and post-complications and quality of life.


title: Multicentric Prospective Study of the Observance of Outpatient Treatments in Reims During the Care Continuum

summary:
The investigators would like to include patients consulting in a Accident and Emergency Department (AED) during the permanence of care the week of March 11 to 17, 2018. The data collection would concern socio-demographic data, their consultation to the AED, the follow-up given to the consultation and would take place by telephone contact of patients within 48 hours of the consultation.

why patients come to the emergency room, what are they waiting for? what are their main motivations? what do they do in emergencies, do they follow the treatments and recommendations?

lead_sponsor: CHU de Reims


title: Appréciation de la Prise en Charge de la Fibrillation Atriale Aux Urgences

acronym: ACFA

summary: Atrial Fibrillation (AF) is the most common disorder of the rhythm disturbance, especially in older adults. The incidence and prevalence of AF increases significantly with age: less than one new case per 1000/year before age 40 to 20/1000 per year after the age of eighty. AF represents 1% of emergency department (ED) visits a third of which are inaugural or recurrent. The causes are varied from cardiac (ischemic cardiac disease, valvular, high blood pressure, heart failure, pericarditis, myocarditis) to extra cardiac etiologies (pulmonary embolism, thyroid disorders, thyrotoxicosis, alcohol, shock, chest trauma, electrolyte disorders, dehydration). While the diagnosis is given quickly by reading the electrocardiogram (ECG), its management both in terms of therapeutic strategy that of choice of care pathway is complex as evidenced by the diversity of possibilities and the difference in practice. Specific recommendations have been published by the French Society of Emergency Medicine in 2015. Our study aims to investigate guidelines implementation in French ED, especially the contribution of diagnostic tests and initiated treatments. Therapeutic strategies are evaluated with a follow up at 3 months, 6 months and 1 year, reporting cardiovascular events and long-term treatment.

lead_sponsor: RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône


title: Medication Reconciliation for Patients Over 65 Years Old : Cost Analysis of the Process Implemented in the Polyvalent Internal Medical Unit of Rennes University Hospital

acronym: CONTEMPS

summary: Among the strategies to secure the patient's care path, medication reconciliation is a powerful approach for the prevention and interception of medication errors.

lead_sponsor: Rennes University Hospital


title: Impact of Personalized SMS in Relay of Therapeutic Education Programs to Improve the Physical Activity of Patients in Rheumatology

summary: Therapeutic patient education is an approach that has shown its usefulness in rheumatology, but the duration of its impact is limited, and therapeutic revisions are regularly necessary. The practice of physical activity is one of the goals of TPE in rheumatology and new technologies, such as SMS messages represent a possible complementary tool to amplify behavioral changes The study primary objective is to evaluate the impact of individualized SMS compared to standard SMS messages on the physical activity of patients with chronic inflammatory rheumatism or osteoporosis, included in a therapeutic education program. Our hypothesis is that individualized SMS has a higher efficiency compared to standard SMS messages to increase the practice of physical activity in these patients.

lead_sponsor: Hôpital Cochin


title: Endovascular Procedures With Computer Assistance in the Chronic Occlusive Arthritis of the Lower Limbs on the Femoro-popliteal Stage.

acronym: PANORAMIC

summary: Pilot study to assess the feasibility of creation of a bone and arterial panorama by 2D-2D registration technique during endovascular femoro-popliteal procedures with a mobile C-arm X-ray system using EndoNaut® software.


intervention_type: Combination Product

acronym: CONFIRM

location_facility: Saint Antoine Hospital - Hematology Department

title: A Multi-center Phase III Randomized Study Comparing Continuous Versus Fixed Duration Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma

summary:
The incorporation of proteasome inhibitors and immunomodulatory drugs into the standard of care has improved the outcome for patients with multiple myeloma (MM) over the past 10 years. However, most patients (>85%) still eventually relapse around 3-4 years after diagnosis, and ultimately die of their disease, despite salvage therapies. Relapse can occur even when complete remission is achieved after first-line therapy.

Currently, daratumumab (Dara) is approved by the american FDA and EMA in combination with lenalidomide (Len) and dexamethasone (Dex) or bortezomib and Dex for the treatment of MM patients who have received at least one prior therapy. Therefore, the Dara-Len-Dex combination is likely to become the most widely used standard of care regimen for MM at the time of first relapse.

However, although approval of the latter combination is meant for until disease progression (PD) ("continuous therapy") (CT), the actual optimal duration of relapse treatment is still unknown. Of note, many experts advocate that a "fixed duration" of therapy should be favored, especially if one can show that CT does not translate into a significant overall survival (OS) benefit. As a matter of fact, given the extremely high cost of such novel agents (>100 KEuros/year/patient), the pharmacoeconomic consequences of a "continuous" versus "fixed" duration therapy are also of utmost importance.

Based on this background, the investigator propose to conduct a non-inferiority phase III randomized, multicenter, open label trial for treatment of MM at first relapse, comparing the Dara-Len-Dex combination administered continuously until PD, versus a fixed duration of 24 months. The choice of this duration is justified by the currently available evidence with respect to achievement of a plateau in terms of deep disease response, patients' compliance, and physicians' preference according to different surveys. The primary objective of this study is to estimate the OS rate at 4 years after diagnosis of relapse and initiation of salvage therapy. The primary endpoint is OS at 4 years after randomization. The analysis will be performed on both per-protocol and intent-to-treat sets of patients.


title: Feasibility Study - The Place of Surgical Management by Fatty Autograft in Patients With Healed Pelvic Eschar. Interest in Secondary Prevention.

acronym: FATSCAR

summary:
Autografting of fat cells is widely used in plastic surgery in breast reconstruction, burn scars, unsightly scars etc. It is known that the autografting of fat cells not only makes it possible to bring adipocytes, and thus to create a volume, but also promotes neo-angiogenesis by providing the growth factors which allows an improvement of the local cutaneous tissue.

Currently the investigators perform this action in their service on healed eschars, by analogy with burn scars that are also dystrophic, so as to improve cutaneous trophicity, and reduce the recurrence of eschars on these scars. However, the literature on the autografting of fat cells on eschars is limited.


title: Evaluation of Pain and Postoperative Nausea Vomiting Incidence in Outpatient Surgery at IUCT-Oncopole Hospital

summary:
The effectiveness of the analgesic and anti-nausea prevention techniques of the investigators justifies being evaluated regularly in order to adapt the management strategy to the specificities of each surgical act.

A first evaluation took place in June 2016 and allowed to identify a category of patients (partial breast surgery with or without axillary gesture) not benefiting from an ideal algological management because justifying in 30% of the cases of a level 3 analgesic remedy in the postoperative recovery room. This use of morphine results in a significant incidence of postoperative nausea and prolonged recovery time before return home harmful to the patient.

With their experience in locoregional anesthesia technique in complete breast surgery (total mastectomy) and aware of the effectiveness of this type of anesthesia on the management of immediate and chronic pain, the investigators have extended their indications of ALR to partial breast surgery in ambulatory.

ReferenceCitation: Gärtner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. Erratum in: JAMA. 2012 Nov 21;308(19):1973.

family: Gärtner

full_name: Rune Gärtner

given: Rune

family: Jensen

full_name: Maj-Britt Jensen

given: Maj-Britt

family: Nielsen

full_name: Jeanette Nielsen

given: Jeanette

family: Ewertz

full_name: Marianne Ewertz

given: Marianne

family: Kroman

full_name: Niels Kroman

given: Niels

family: Kehlet

full_name: Henrik Kehlet

given: Henrik

journal_name: JAMA

evidence: open (via free pdf)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Prevalence of and Factors Associated With Persistent Pain Following Breast Cancer Surgery

ReferenceCitation: Fuzier R, Puel F, Izard P, Sommet A, Pierre S. Prospective cohort study assessing chronic pain in patients following minor surgery for breast cancer. J Anesth. 2017 Apr;31(2):246-254. doi: 10.1007/s00540-016-2288-9. Epub 2016 Nov 24.

family: Fuzier

full_name: Régis Fuzier

given: Régis

family: Puel

full_name: Floriane Puel

given: Floriane

family: Izard

full_name: Philippe Izard

family: Sommet

full_name: Agnès Sommet

given: Agnès

family: Pierre

full_name: Sébastien Pierre

given: Sébastien

journal_name: Journal of Anesthesia

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.

family: Blanco

full_name: R. Blanco

given: R.

family: Fajardo

full_name: M. Fajardo

given: M.

family: Parras Maldonado

full_name: T. Parras Maldonado

given: T.

journal_name: Revista Española de Anestesiología y Reanimación

title: Ultrasound description of Pecs II (modified Pecs I): A novel approach to breast surgery

ReferenceCitation: Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lantéri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. Epub 2005 Jan 26.

ReferenceCitation: Kumar SP. Utilization of brief pain inventory as an assessment tool for pain in patients with cancer: a focused review. Indian J Palliat Care. 2011 May;17(2):108-15. doi: 10.4103/0973-1075.84531.

family: Kumar

full_name: SenthilP Kumar

title: Utilization of brief pain inventory as an assessment tool for pain in patients with cancer: A focused review


title: Interest of Intravenous Dexmedetomidine (Dexdor®) in the Knee Replacement Surgery Performed Under Locoregional Anesthesia: a Randomized, Double Blind, Controlled Clinical Trial

acronym: DIVA

summary: Intravenous dexmedetomidine is a drug used in reanimation with sedative, anxiolytic and sympatholytic properties. Recent studies showed useful properties for anaesthesia : decrease of morphine consumption after a various type of surgery, sedative effect on patients under regional anaesthesia, prolongation of central or peripheral regional block. Dose-ranging study for intravenous dexmedetomidine showed that 2 µg/kg is an effective dose to prolong interscalene block. This study aims to determine if intravenous dexmedetomidine at 2 µg/kg allows a longer analgesic duration after a quadri-block (femoral, subgluteal sciatic, obturator and alateral cutaneous nerve blocks) with ropivacaine 0.32% for total knee replacement under regional anaesthesia.

ReferenceCitation: Chassery C, Marty P, Rontes O, Chaubard M, Vuillaume C, Basset B, Merouani M, Marquis C, De Lussy A, Delbos MC, Casalprim J, Bataille B, Naudin C, Ferre F, Delbos A. Total knee arthroplasty under quadruple nerve block with ropivacaine 0.32%: effect of addition of intravenous dexmedetomidine to intravenous dexamethasone on analgesic duration. Reg Anesth Pain Med. 2021 Feb;46(2):104-110. doi: 10.1136/rapm-2020-101749. Epub 2020 Oct 21.

family: Chassery

full_name: Clement Chassery

given: Clement

family: Marty

full_name: Philippe Marty

given: Philippe

family: Rontes

full_name: Olivier Rontes

given: Olivier

family: Chaubard

full_name: Martine Chaubard

given: Martine

family: Vuillaume

full_name: Corine Vuillaume

given: Corine

family: Basset

full_name: Bertrand Basset

given: Bertrand

family: Merouani

full_name: Mehdi Merouani

given: Mehdi

family: Marquis

full_name: Constance Marquis

given: Constance

family: De Lussy

full_name: Anne De Lussy

given: Anne

family: Delbos

full_name: Marie-Claude Delbos

given: Marie-Claude

family: Casalprim

full_name: Julie Casalprim

given: Julie

family: Bataille

full_name: Benoit Bataille

given: Benoit

family: Naudin

full_name: Cecile Naudin

given: Cecile

family: Ferre

full_name: Fabrice Ferre

given: Fabrice

full_name: Alain Delbos

given: Alain

journal_name: Regional Anesthesia & Pain Medicine

lead_sponsor: CMC Ambroise Paré


title: Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement.

acronym: ICTUS

summary: Management of NSTEMI in emergency departements represent 10% of the global activity. Since the the last European Society of Cardiology recommendation the use of an 1 hour rule-in and rule-out protocol is recommended combined with high-sensitivity troponin. But studies show 3% of the patients are false negative using this protocol. This study aims at analysing the feasibility of this protocol in an Emergency Departement and the security of this protocol if combined with a pre-troponin probability score.


title: Evaluation of the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus

acronym: CALIGALOC

summary: To assess the benefit of an anti-varus ankle foot orthosis (CALIGALOC, Bauerfeind) on gait and balance parameters in hemiparetic patients.

lead_sponsor: University Hospital, Lille


title: Children Peritonitis Ecology at CHU de Rennes - (IIAPEDIA)

acronym: IIAPEDIA

summary: The main objectif is assess the germs (species + antibiograms) implicated in children intra-abdominal infections (community acquired or nosocomial ) at CHU de Rennes.


title: Prevention Study, on Loss of Autonomy and Physical Dependence, Based on Physical Exercises and Nutrition Counseling Applied to 70 Years Old and More People.

acronym: PREPA

summary:
According to several reports, the percentage of persons aged of more than 80 years is going to be doubled for the 25 years, to reach 10 % of the population. This implies an adaptation of practices of taken care for elderly people. Furthermore, the expectancy of life without any disability at 65 years old is 10.4 years and remains much lower than the general expectancy of life, which is of 24.4 years for women and 19.1 years for men.

Among predictive factors of loss of autonomy, the loss of mobility and muscular weakness are major components (OR=3.28 up to 3 years). These two factors are the origins for disabilities being responsible of falls, fractures, which lead to quality of life diminution, and increase of mortality.

The only components easily employed in a preventive manner and which have proved their efficacy are physical exercise and nutrition. But programs nowadays are still not implemented into primary taken care.

A multimodal program including these two components for patients at risk of loss of mobility is an imperative of public health.

location_facility: Service de Médecine Gériatrique Groupement Hospitalier Sud


title: Evaluation of the Uses of a Digital-assisted Self-rehabilitation Device Coupled With a Tele-reeducative Follow-up in Patients With Parkinson's Disease on a Defined Health Area (TELE-PARK)

acronym: TELE-PARK

summary: Evaluate the use by the patient and his family and professional environment of a self-rehabilitation device with follow-up in tele-rehabilitation in people with Parkinson's disease taking into account the different actors within a health area (health professionals and paramedics in structure and in liberal).

lead_sponsor: Pôle Saint Hélier


title: Sudden Cardiac Death in Congenital Heart Diseases With a Systemic Right Ventricle

acronym: STARSII

summary:
In complete transposition of the great arteries (TGA) with previous atrial switch repair, and congenitally corrected transposition of the great arteries (ccTGA), the morphological right ventricle and its tricuspid valve continue to support the systemic circulation. This results in late complications including including sudden death.

This retrospective multicentric study aims to evaluate the prevalence of SCD in a contemporary population of patients with a systemic RV and identify specific risk factors for SCD and hemodynamically significant ventricular arrhythmia This registry records demographics, clinical, imaging data, electrophysiological and laboratory of patients with a sRV and a transposition of the great arteries Primary end points are defined by sudden cardiac death, near-miss sudden death, as well as sustained VT requiring defibrillation.

ReferenceCitation: Kammeraad JA, van Deurzen CH, Sreeram N, Bink-Boelkens MT, Ottenkamp J, Helbing WA, Lam J, Sobotka-Plojhar MA, Daniels O, Balaji S. Predictors of sudden cardiac death after Mustard or Senning repair for transposition of the great arteries. J Am Coll Cardiol. 2004 Sep 1;44(5):1095-102.

ReferenceCitation: Schwerzmann M, Salehian O, Harris L, Siu SC, Williams WG, Webb GD, Colman JM, Redington A, Silversides CK. Ventricular arrhythmias and sudden death in adults after a Mustard operation for transposition of the great arteries. Eur Heart J. 2009 Aug;30(15):1873-9. doi: 10.1093/eurheartj/ehp179. Epub 2009 May 22.

family: Schwerzmann

full_name: M. Schwerzmann

given: M.

family: Salehian

full_name: O. Salehian

given: O.

family: Harris

full_name: L. Harris

given: L.

family: Siu

full_name: S. C. Siu

given: S. C.

family: Williams

full_name: W. G. Williams

given: W. G.

family: Webb

full_name: G. D. Webb

given: G. D.

family: Colman

full_name: J. M. Colman

given: J. M.

family: Redington

full_name: A. Redington

given: A.

family: Silversides

full_name: C. K. Silversides

given: C. K.

journal_name: European Heart Journal

oa_colors: green hybrid

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

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

repository_institution: reroDoc Digital Library

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Khairy P, Harris L, Landzberg MJ, Fernandes SM, Barlow A, Mercier LA, Viswanathan S, Chetaille P, Gordon E, Dore A, Cecchin F. Sudden death and defibrillators in transposition of the great arteries with intra-atrial baffles: a multicenter study. Circ Arrhythm Electrophysiol. 2008 Oct;1(4):250-7. doi: 10.1161/CIRCEP.108.776120. Epub 2008 Sep 12.

name: From the Canadian Adult Congenital Heart Network, Montreal, Quebec, Canada (P.K., L.H., A.B., L.A.M., P.C., E.G., A.D.); Leeds General Infirmary, Leeds, United Kingdom (S.V., P.C.); and Children’s Hospital, Boston, Mass (P.K., M.J.L., S.M.F., F.C.).

family: Khairy

full_name: Paul Khairy

given: Paul

full_name: Louise Harris

given: Louise

family: Landzberg

full_name: Michael J. Landzberg

given: Michael J.

family: Fernandes

full_name: Susan M. Fernandes

given: Susan M.

family: Barlow

full_name: Amanda Barlow

given: Amanda

family: Mercier

full_name: Lise-Andrée Mercier

given: Lise-Andrée

family: Viswanathan

full_name: Sangeetha Viswanathan

given: Sangeetha

family: Chetaille

full_name: Philippe Chetaille

journal_name: Circulation: Arrhythmia and Electrophysiology

title: Sudden Death and Defibrillators in Transposition of the Great Arteries With Intra-atrial Baffles


title: Monitoring the HePAtological TOXicity of Drugs

acronym: HePATOX

summary: Several drugs and chemotherapies seem to have an impact on the hepatological system. This study investigates reports of hepatological toxicities, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

time_perspective: Cross-Sectional

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM