ReferenceCitation: Idiopathic Pulmonary Fibrosis Clinical Research Network, Raghu G, Anstrom KJ, King TE Jr, Lasky JA, Martinez FJ. Prednisone, azathioprine, and N-acetylcysteine for pulmonary fibrosis. N Engl J Med. 2012 May 24;366(21):1968-77. doi: 10.1056/NEJMoa1113354. Epub 2012 May 20.

ReferenceCitation: Collard HR, Moore BB, Flaherty KR, Brown KK, Kaner RJ, King TE Jr, Lasky JA, Loyd JE, Noth I, Olman MA, Raghu G, Roman J, Ryu JH, Zisman DA, Hunninghake GW, Colby TV, Egan JJ, Hansell DM, Johkoh T, Kaminski N, Kim DS, Kondoh Y, Lynch DA, Müller-Quernheim J, Myers JL, Nicholson AG, Selman M, Toews GB, Wells AU, Martinez FJ; Idiopathic Pulmonary Fibrosis Clinical Research Network Investigators. Acute exacerbations of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2007 Oct 1;176(7):636-43. Epub 2007 Jun 21. Review.

ReferenceCitation: Oishi K, Mimura-Kimura Y, Miyasho T, Aoe K, Ogata Y, Katayama H, Murata Y, Ueoka H, Matsumoto T, Mimura Y. Association between cytokine removal by polymyxin B hemoperfusion and improved pulmonary oxygenation in patients with acute exacerbation of idiopathic pulmonary fibrosis. Cytokine. 2013 Jan;61(1):84-9. doi: 10.1016/j.cyto.2012.08.032. Epub 2012 Sep 26.

ReferenceCitation: Morawiec E, Tillie-Leblond I, Pansini V, Salleron J, Remy-Jardin M, Wallaert B. Exacerbations of idiopathic pulmonary fibrosis treated with corticosteroids and cyclophosphamide pulses. Eur Respir J. 2011 Dec;38(6):1487-9. doi: 10.1183/09031936.00127311.

ReferenceCitation: Simon-Blancal V, Freynet O, Nunes H, Bouvry D, Naggara N, Brillet PY, Denis D, Cohen Y, Vincent F, Valeyre D, Naccache JM. Acute exacerbation of idiopathic pulmonary fibrosis: outcome and prognostic factors. Respiration. 2012;83(1):28-35. doi: 10.1159/000329891. Epub 2011 Aug 23.

ReferenceCitation: Agarwal R, Jindal SK. Acute exacerbation of idiopathic pulmonary fibrosis: a systematic review. Eur J Intern Med. 2008 Jun;19(4):227-35. doi: 10.1016/j.ejim.2007.04.024. Epub 2008 Jan 16. Review.

ReferenceCitation: Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Müller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schünemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.

family: Raghu

full_name: Ganesh Raghu

given: Ganesh

family: Collard

full_name: Harold R. Collard

given: Harold R.

family: Egan

full_name: Jim J. Egan

given: Jim J.

family: Martinez

full_name: Fernando J. Martinez

given: Fernando J.

family: Behr

full_name: Juergen Behr

given: Juergen

family: Brown

full_name: Kevin K. Brown

given: Kevin K.

family: Colby

full_name: Thomas V. Colby

given: Thomas V.

family: Cordier

full_name: Jean-François Cordier

given: Jean-François

family: Flaherty

full_name: Kevin R. Flaherty

given: Kevin R.

family: Lasky

full_name: Joseph A. Lasky

given: Joseph A.

family: Lynch

full_name: David A. Lynch

given: David A.

family: Ryu

full_name: Jay H. Ryu

given: Jay H.

family: Swigris

full_name: Jeffrey J. Swigris

given: Jeffrey J.

family: Wells

full_name: Athol U. Wells

given: Athol U.

family: Ancochea

full_name: Julio Ancochea

given: Julio

family: Bouros

full_name: Demosthenes Bouros

given: Demosthenes

family: Carvalho

full_name: Carlos Carvalho

given: Carlos

family: Costabel

full_name: Ulrich Costabel

given: Ulrich

family: Ebina

full_name: Masahito Ebina

given: Masahito

family: Hansell

full_name: David M. Hansell

given: David M.

family: Johkoh

full_name: Takeshi Johkoh

given: Takeshi

family: Kim

full_name: Dong Soon Kim

given: Dong Soon

family: King

full_name: Talmadge E. King

given: Talmadge E.

suffix: Jr.

journal_name: American Journal of Respiratory and Critical Care Medicine

title: An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management

ReferenceCitation: Cottin V, Crestani B, Valeyre D, Wallaert B, Cadranel J, Dalphin JC, Delaval P, Israel-Biet D, Kessler R, Reynaud-Gaubert M, Cordier JF, Aguilaniu B, Bouquillon B, Carré P, Danel C, Faivre JB, Ferreti G, Just N, Kouzan S, Lebargy F, Marchand Adam S, Philippe B, Prévot G, Stach B, Thivolet-Béjui F; French National Reference and Competence Centers for Rare Diseases; Societe de Pneumologies de Langue Francaise. [French practical guidelines for the diagnosis and management of idiopathic pulmonary fibrosis. From the National Reference and the Competence centers for rare diseases and the Société de Pneumologie de Langue Française]. Rev Mal Respir. 2013 Dec;30(10):879-902. doi: 10.1016/j.rmr.2013.09.007. Epub 2013 Oct 25. French. Erratum in: Rev Mal Respir. 2014 Feb;31(2):194-5.

title: Recommandations pratiques pour le diagnostic et la prise en charge de la fibrose pulmonaire idiopathique. Élaborées par le centre national de référence et les centres de compétence pour les maladies pulmonaires rares sous l’égide de la Société de pneumologie de langue française

ReferenceCitation: Nalysnyk L, Cid-Ruzafa J, Rotella P, Esser D. Incidence and prevalence of idiopathic pulmonary fibrosis: review of the literature. Eur Respir Rev. 2012 Dec 1;21(126):355-61. doi: 10.1183/09059180.00002512. Review.

ReferenceCitation: Wuyts WA, Agostini C, Antoniou KM, Bouros D, Chambers RC, Cottin V, Egan JJ, Lambrecht BN, Lories R, Parfrey H, Prasse A, Robalo-Cordeiro C, Verbeken E, Verschakelen JA, Wells AU, Verleden GM. The pathogenesis of pulmonary fibrosis: a moving target. Eur Respir J. 2013 May;41(5):1207-18. doi: 10.1183/09031936.00073012. Epub 2012 Oct 25. Review.

ReferenceCitation: Martinez FJ, Safrin S, Weycker D, Starko KM, Bradford WZ, King TE Jr, Flaherty KR, Schwartz DA, Noble PW, Raghu G, Brown KK; IPF Study Group. The clinical course of patients with idiopathic pulmonary fibrosis. Ann Intern Med. 2005 Jun 21;142(12 Pt 1):963-7.

ReferenceCitation: Collard HR, Yow E, Richeldi L, Anstrom KJ, Glazer C; IPFnet investigators. Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials. Respir Res. 2013 Jul 13;14:73. doi: 10.1186/1465-9921-14-73.

ReferenceCitation: Churg A, Müller NL, Silva CI, Wright JL. Acute exacerbation (acute lung injury of unknown cause) in UIP and other forms of fibrotic interstitial pneumonias. Am J Surg Pathol. 2007 Feb;31(2):277-84.

ReferenceCitation: Papiris SA, Manali ED, Kolilekas L, Kagouridis K, Triantafillidou C, Tsangaris I, Roussos C. Clinical review: idiopathic pulmonary fibrosis acute exacerbations--unravelling Ariadne's thread. Crit Care. 2010;14(6):246. doi: 10.1186/cc9241. Epub 2010 Dec 22. Review.

ReferenceCitation: Song JW, Hong SB, Lim CM, Koh Y, Kim DS. Acute exacerbation of idiopathic pulmonary fibrosis: incidence, risk factors and outcome. Eur Respir J. 2011 Feb;37(2):356-63. doi: 10.1183/09031936.00159709. Epub 2010 Jul 1.

ReferenceCitation: Akira M, Kozuka T, Yamamoto S, Sakatani M. Computed tomography findings in acute exacerbation of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2008 Aug 15;178(4):372-8. doi: 10.1164/rccm.200709-1365OC. Epub 2008 May 1.

ReferenceCitation: Ambrosini V, Cancellieri A, Chilosi M, Zompatori M, Trisolini R, Saragoni L, Poletti V. Acute exacerbation of idiopathic pulmonary fibrosis: report of a series. Eur Respir J. 2003 Nov;22(5):821-6.

ReferenceCitation: Kim DS, Park JH, Park BK, Lee JS, Nicholson AG, Colby T. Acute exacerbation of idiopathic pulmonary fibrosis: frequency and clinical features. Eur Respir J. 2006 Jan;27(1):143-50.

ReferenceCitation: Fujimoto K, Taniguchi H, Johkoh T, Kondoh Y, Ichikado K, Sumikawa H, Ogura T, Kataoka K, Endo T, Kawaguchi A, Müller NL. Acute exacerbation of idiopathic pulmonary fibrosis: high-resolution CT scores predict mortality. Eur Radiol. 2012 Jan;22(1):83-92. doi: 10.1007/s00330-011-2211-6. Epub 2011 Aug 7.

ReferenceCitation: Kondoh Y, Taniguchi H, Kitaichi M, Yokoi T, Johkoh T, Oishi T, Kimura T, Nishiyama O, Kato K, du Bois RM. Acute exacerbation of interstitial pneumonia following surgical lung biopsy. Respir Med. 2006 Oct;100(10):1753-9. Epub 2006 Apr 3.

ReferenceCitation: Rice AJ, Wells AU, Bouros D, du Bois RM, Hansell DM, Polychronopoulos V, Vassilakis D, Kerr JR, Evans TW, Nicholson AG. Terminal diffuse alveolar damage in relation to interstitial pneumonias. An autopsy study. Am J Clin Pathol. 2003 May;119(5):709-14.

ReferenceCitation: Tomioka H, Sakurai T, Hashimoto K, Iwasaki H. Acute exacerbation of idiopathic pulmonary fibrosis: role of Chlamydophila pneumoniae infection. Respirology. 2007 Sep;12(5):700-6.

ReferenceCitation: de Groot K, Harper L, Jayne DR, Flores Suarez LF, Gregorini G, Gross WL, Luqmani R, Pusey CD, Rasmussen N, Sinico RA, Tesar V, Vanhille P, Westman K, Savage CO; EUVAS (European Vasculitis Study Group). Pulse versus daily oral cyclophosphamide for induction of remission in antineutrophil cytoplasmic antibody-associated vasculitis: a randomized trial. Ann Intern Med. 2009 May 19;150(10):670-80.

ReferenceCitation: Tashkin DP, Elashoff R, Clements PJ, Goldin J, Roth MD, Furst DE, Arriola E, Silver R, Strange C, Bolster M, Seibold JR, Riley DJ, Hsu VM, Varga J, Schraufnagel DE, Theodore A, Simms R, Wise R, Wigley F, White B, Steen V, Read C, Mayes M, Parsley E, Mubarak K, Connolly MK, Golden J, Olman M, Fessler B, Rothfield N, Metersky M; Scleroderma Lung Study Research Group. Cyclophosphamide versus placebo in scleroderma lung disease. N Engl J Med. 2006 Jun 22;354(25):2655-66.

ReferenceCitation: Cottin V, Cadranel J, Crestani B, Dalphin JC, Delaval P, Israel-Biet D, Kessler R, Reynaud-Gaubert M, Valeyre D, Wallaert B, Bouquillon B, Cordier JF. Management of idiopathic pulmonary fibrosis in France: a survey of 1244 pulmonologists. Respir Med. 2014 Jan;108(1):195-202. doi: 10.1016/j.rmed.2013.11.017. Epub 2013 Dec 3.

ReferenceCitation: Naccache JM, Jouneau S, Didier M, Borie R, Cachanado M, Bourdin A, Reynaud-Gaubert M, Bonniaud P, Israël-Biet D, Prévot G, Hirschi S, Lebargy F, Marchand-Adam S, Bautin N, Traclet J, Gomez E, Leroy S, Gagnadoux F, Rivière F, Bergot E, Gondouin A, Blanchard E, Parrot A, Blanc FX, Chabrol A, Dominique S, Gibelin A, Tazi A, Berard L, Brillet PY, Debray MP, Rousseau A, Kerjouan M, Freynet O, Dombret MC, Gamez AS, Nieves A, Beltramo G, Pastré J, Le Borgne-Krams A, Dégot T, Launois C, Plantier L, Wémeau-Stervinou L, Cadranel J, Chenivesse C, Valeyre D, Crestani B, Cottin V, Simon T, Nunes H; EXAFIP investigators and the OrphaLung network. Cyclophosphamide added to glucocorticoids in acute exacerbation of idiopathic pulmonary fibrosis (EXAFIP): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021 Sep 7. pii: S2213-2600(21)00354-4. doi: 10.1016/S2213-2600(21)00354-4. [Epub ahead of print]

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

ReferenceCitation: Naccache JM, Montil M, Cadranel J, Cachanado M, Cottin V, Crestani B, Valeyre D, Wallaert B, Simon T, Nunes H. Study protocol: exploring the efficacy of cyclophosphamide added to corticosteroids for treating acute exacerbation of idiopathic pulmonary fibrosis; a randomized double-blind, placebo-controlled, multi-center phase III trial (EXAFIP). BMC Pulm Med. 2019 Apr 11;19(1):75. doi: 10.1186/s12890-019-0830-x.

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

title: Cyclophosphamide Added to Corticosteroid in the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Placebo-controlled Randomized Trial

summary: Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is a major event of IPF with an annual incidence between 5 and 10% and is responsible for the death of one third of IPF patients. When AE-IPF occurs, it is associated with poor survival with an overall mortality at 3 months upper of 50%. To date, no treatment has been proved to be effective in AE-IPF but the efficacy of cyclophosphamide (CYC) on survival has been suggested, mainly by retrospective series and needs to be confirmed. This confirmation is mandatory to improve prognosis of AE-IPF but also to avoid unsuspected deleterious effect as it as been shown with immunosuppressor in stable IPF.


title: Reintroduction of Small Doses of Food in Allergic Children to Lightening the Elimination Diet.

acronym: MANOE

summary: Reintroduction of small doses of food in allergic children to lightening the elimination diet.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

enrollment_type: Anticipated

lead_sponsor: University Hospital, Angers

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: CALVIH: Determination of Kidney Stone Risk Factors in Patients Infected With HIV

acronym: CALVIH

summary: The purpose of this study is to define the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in HIV1 patients.

study_type: Observational

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Abgrall S, Rachas A, Tourret J, Isnard-Bagnis C, Billaud E, Tattevin P, Costagliola D, Guiguet M, Durieux P; French Hospital Database on HIV. A multifaceted intervention designed to improve medical management of moderate to advanced chronic kidney disease in HIV-infected patients: a cluster randomized trial. Clin Infect Dis. 2015 Aug 1;61(3):375-84. doi: 10.1093/cid/civ310. Epub 2015 Apr 22.

family: Abgrall

full_name: Sophie Abgrall

given: Sophie

sequence: first

family: Rachas

full_name: Antoine Rachas

given: Antoine

sequence: additional

family: Tourret

full_name: Jérome Tourret

given: Jérome

family: Isnard-Bagnis

full_name: Corinne Isnard-Bagnis

given: Corinne

family: Billaud

full_name: Eric Billaud

given: Eric

family: Tattevin

full_name: Pierre Tattevin

given: Pierre

family: Costagliola

full_name: Dominique Costagliola

given: Dominique

family: Guiguet

full_name: Marguerite Guiguet

given: Marguerite

family: Durieux

full_name: Pierre Durieux

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Infectious Diseases

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: A Multifaceted Intervention Designed to Improve Medical Management of Moderate to Advanced Chronic Kidney Disease in HIV-Infected Patients: A Cluster Randomized Trial

ReferenceCitation: Tourret J, Deray G, Isnard-Bagnis C. Tenofovir effect on the kidneys of HIV-infected patients: a double-edged sword? J Am Soc Nephrol. 2013 Oct;24(10):1519-27. doi: 10.1681/ASN.2012080857. Epub 2013 Sep 19. Review.

full_name: Jérôme Tourret

given: Jérôme

family: Deray

full_name: Gilbert Deray

given: Gilbert

journal_name: Journal of the American Society of Nephrology

oa_colors: green other

oa_host_type: publisher;repository

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: American Society of Nephrology (ASN)

publisher_dissemination: American Society of Nephrology

publisher_group: American Society of Nephrology

publisher_normalized: American Society of Nephrology

title: Tenofovir Effect on the Kidneys of HIV-Infected Patients: A Double-Edged Sword?

ReferenceCitation: Bigé N, Lanternier F, Viard JP, Kamgang P, Daugas E, Elie C, Jidar K, Walker-Combrouze F, Peraldi MN, Isnard-Bagnis C, Servais A, Lortholary O, Noël LH, Bollée G. Presentation of HIV-associated nephropathy and outcome in HAART-treated patients. Nephrol Dial Transplant. 2012 Mar;27(3):1114-21. doi: 10.1093/ndt/gfr376. Epub 2011 Jul 10.

family: Bige

full_name: N. Bige

given: N.

ReferenceCitation: Tourret J, Tostivint I, Deray G, Isnard-Bagnis C. [Kidney diseases in HIV-infected patients]. Nephrol Ther. 2009 Nov;5(6):576-91. doi: 10.1016/j.nephro.2009.02.007. Epub 2009 Apr 16. French.

title: Néphropathies rencontrées au cours de l’infection par le virus de l’immunodéficience humaine (VIH)


type: Registry Identifier

title: Impact of a Transportable Customizable and Scalable Sitting Positioning Device on Swallowing Disorders

acronym: DATP-DEG

summary:
When the seat is a vehicle for disabled person, postural adaptation methodology is known and, on prescription, there is possibility of financial support for technical posture assists. For people who use a standard seat, a chair for example, there is no satisfactory existing hardware.

A transportable customisable and scalable sitting positioning device (DATP device), to be placed on a standard seat, is a solution that might fit in the home, in specialized foster homes or in institutions for the elderly. Such a device has been developed but earnings on swallowing disorders have to be validated.

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Actual

lead_sponsor: University Hospital, Toulouse

intervention_type: Device

status_simplified: Completed


title: Interest of High Flow Nasal Cannula (HFNC) Versus Non Invasive Ventilation During the Initial Management of Severe Bronchiolitis in Infants

acronym: TRAMONTANE

summary:
The purpose of the study is to evaluate prospectively the clinical benefits of High flow nasal canula (HFNC: 2l/kg/min) versus nasal CPAP( continuous positive airway pressure) (n-CPAP: 7 cmH2O) in the initial management of bronchiolitis in infants.
Design: non-inferiority study, prospective, controlled, randomized, multi-center.
Design: Infants less than 6 month admitted in pediatric intensive care unit for respiratory distress (mWCAS >3) secondary to bronchiolitis but not requiring mechanical ventilation will be randomized in two groups: "n-CPAP"(nasal continuous positive airway pressure) or "HFNC" during 24 hours.

Conditions of measurements:

Primary endpoint: Proportion of failure in both arms during the first 24 hours. Failure criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea.

Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate, EDIN score, skin lesions, FiO2 (fraction of inspired oxygen

) required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2 (carbon dioxide partial pressure) (correlated to an initial gas analysis), Report SpO2 / FiO2

Statistic: Intention to treat Analysis. Expected number of patients: 71 per arm: 142 children.
Study Schedule: October 2014-April 2016

primary_purpose: Treatment

lead_sponsor: University Hospital, Montpellier


acronym: DysA

summary: The main objective of this trial is to evaluate the prevalence of alpha-1 antitrypsin quantitative and functional deficiency in an adult French population presenting with pulmonary emphysema. Phenotypic and genotypic studies will be carried whenever quantitative and/or functional deficiency will be displayed.

primary_purpose: Diagnostic

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Louis Pradel - service de pneumologie


title: Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition Assessed by F-FDG Petscan

acronym: PETANC

summary: Evaluate the feasability to determine the difference of tumoral metabolism before and after artificial nutrition.

study_start_date_type: Actual

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

lead_sponsor_type: industriel


title: Determine the Main Muscle Participant in the Deformation of the Elbow in Hemiplegic Patients

acronym: FLEXELBOW

summary: The aim of this study is to determinate what are the main muscles regularly involved in the spastic pattern in flexion of the elbow using the selective motor nerve blocks of the elbow flexors. Three selective motor block nerves will be carry out in order to assess the gain of the range of motion (passive and active) of the elbow after each Motor Block Nerve.

primary_purpose: Prevention

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

intervention_type: Procedure


title: Myocardial Dysfunction at Early Phase of Traumatic Brain Injury : Evaluation by Two Dimensional and Speckle Tracking Transthoracic Echocardiography

acronym: Echo-TC

summary: Traumatic brain injury (TBI) is a frequent pathology leading to major morbidity and mortality in young people. Cerebral flood flow maintenance is a major goal directed therapy to improve the prognosis of the patient. Due to cerebral-myocardial interaction, a myocardial dysfunction might occur at the early phase of the traumatic brain injury. This myocardial dysfunction could be partly responsible for a decrease in cerebral blood flow. In such case, improving myocardial dysfunction may help to increase cerebral blood flow and improve patient prognosis. In clinical practice the easiest and non invasive way to explore myocardial dysfunction is with transthoracic echocardiography. The objective of this trial is to investigate myocardial dysfunction at the early phase of traumatic brain injury, compared with a controlled group without TBI.

design_allocation: Non-Randomized

ReferenceType: background

ReferenceCitation: Bahloul M, Chaari AN, Kallel H, Khabir A, Ayadi A, Charfeddine H, Hergafi L, Chaari AD, Chelly HE, Ben Hamida C, Rekik N, Bouaziz M. Neurogenic pulmonary edema due to traumatic brain injury: evidence of cardiac dysfunction. Am J Crit Care. 2006 Sep;15(5):462-70.

ReferenceCitation: Eagle KA, Berger PB, Calkins H, Chaitman BR, Ewy GA, Fleischmann KE, Fleisher LA, Froehlich JB, Gusberg RJ, Leppo JA, Ryan T, Schlant RC, Winters WL Jr, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Jacobs AK, Hiratzka LF, Russell RO, Smith SC Jr; American College of Cardiology; American Heart Association. ACC/AHA guideline update for perioperative cardiovascular evaluation for noncardiac surgery--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1996 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery). J Am Coll Cardiol. 2002 Feb 6;39(3):542-53. Erratum in: J Am Coll Cardiol. 2006 Jun 6;47(11):2356.

ReferenceCitation: Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63.

ReferenceCitation: Mor-Avi V, Lang RM, Badano LP, Belohlavek M, Cardim NM, Derumeaux G, Galderisi M, Marwick T, Nagueh SF, Sengupta PP, Sicari R, Smiseth OA, Smulevitz B, Takeuchi M, Thomas JD, Vannan M, Voigt JU, Zamorano JL. Current and evolving echocardiographic techniques for the quantitative evaluation of cardiac mechanics: ASE/EAE consensus statement on methodology and indications endorsed by the Japanese Society of Echocardiography. J Am Soc Echocardiogr. 2011 Mar;24(3):277-313. doi: 10.1016/j.echo.2011.01.015.

ReferenceCitation: Moussouttas M, Lai EW, Khoury J, Huynh TT, Dombrowski K, Pacak K. Determinants of central sympathetic activation in spontaneous primary subarachnoid hemorrhage. Neurocrit Care. 2012 Jun;16(3):381-8. doi: 10.1007/s12028-012-9673-5.

ReferenceCitation: Prathep S, Sharma D, Hallman M, Joffe A, Krishnamoorthy V, Mackensen GB, Vavilala MS. Preliminary report on cardiac dysfunction after isolated traumatic brain injury. Crit Care Med. 2014 Jan;42(1):142-7. doi: 10.1097/CCM.0b013e318298a890.

ReferenceCitation: Rosenthal G, Hemphill JC 3rd, Sorani M, Martin C, Morabito D, Obrist WD, Manley GT. Brain tissue oxygen tension is more indicative of oxygen diffusion than oxygen delivery and metabolism in patients with traumatic brain injury. Crit Care Med. 2008 Jun;36(6):1917-24. doi: 10.1097/CCM.0b013e3181743d77.

ReferenceCitation: Schrader H, Hall C, Zwetnow NN. Effects of prolonged supratentorial mass expansion on regional blood flow and cardiovascular parameters during the Cushing response. Acta Neurol Scand. 1985 Sep;72(3):283-94.

ReferenceCitation: Shanlin RJ, Sole MJ, Rahimifar M, Tator CH, Factor SM. Increased intracranial pressure elicits hypertension, increased sympathetic activity, electrocardiographic abnormalities and myocardial damage in rats. J Am Coll Cardiol. 1988 Sep;12(3):727-36.

ReferenceCitation: Shivalkar B, Van Loon J, Wieland W, Tjandra-Maga TB, Borgers M, Plets C, Flameng W. Variable effects of explosive or gradual increase of intracranial pressure on myocardial structure and function. Circulation. 1993 Jan;87(1):230-9.

ReferenceCitation: Song HS, Back JH, Jin DK, Chung PW, Moon HS, Suh BC, Kim YB, Kim BM, Woo HY, Lee YT, Park KY. Cardiac troponin T elevation after stroke: relationships between elevated serum troponin T, stroke location, and prognosis. J Clin Neurol. 2008 Jun;4(2):75-83. doi: 10.3988/jcn.2008.4.2.75. Epub 2008 Jun 20.

ReferenceCitation: Sosin DM, Sniezek JE, Waxweiler RJ. Trends in death associated with traumatic brain injury, 1979 through 1992. Success and failure. JAMA. 1995 Jun 14;273(22):1778-80.

ReferenceType: derived

ReferenceCitation: Cuisinier A, Maufrais C, Payen JF, Nottin S, Walther G, Bouzat P. Myocardial function at the early phase of traumatic brain injury: a prospective controlled study. Scand J Trauma Resusc Emerg Med. 2016 Oct 28;24(1):129.

lead_sponsor: University Hospital, Grenoble


title: Development of a Therapeutic Education Intervention Improving Sexuality in Patients With Prostate Cancer Treated With Radical Prostatectomy

acronym: PEPs PROSTATE

summary:
The aim is to built a Therapeutic Education Program for patients treated with radical prostatectomy in order to improve their sexuality.

This study is carried out in two steps :

Identification of specific educational objectives through a sociological study, with interviews and focus groups conducted and analyzed by a sociologist. Patients from the urology department of the hospital center (CH) Lyon Sud - Hospices Civils de Lyon (HCL) will be included
Development of the program by a caregiver education expert (Centre Hygée), adapted partly from results of the qualitative study and partly from concepts and tools from the Education Sciences.

lead_sponsor: Institut de Cancérologie de la Loire


title: SIMulation for HEmofiltration in Intensive caRe Unit

acronym: SIMHeR

summary:
Continuous Veno-Veinous Hemofiltration (CVVH) is a frequently used renal replacement therapy in intensive care units for patients with acute renal failure. In theory, this therapy should be continuous, 24 hours/day.

However, it is wellknown that actual duration of CVVH sessions is much lower than scheduled, with frequent "circuit down-times" (between 1 to 6 hours/day). There are many reasons for premature ending of CVVH sessions (i.e. catheter dysfunction, wrong settings, low anticoagulation…), but early detection of any dysfunction may prevent (at least in part) the CVVH circuit coagulation. ICU Nurses are on the first line to manage CVVH sessions, particularly in case of alarms.

High-fidelity simulation has been recently proposed for health care provider education. It has been consistently associated with large effects for outcomes of knowledge, skills, and behaviors but with moderate effects for patient related outcomes. Indeed, few studies have assess the impact of simulation on patient outcome following complexe procedures, that implies team work in addition to individual skills.

In our 12-bed surgical ICU, investigators have decided to implement CVVH technics (in addition to the dialysis that we already used). Before implementing this new technic in the ICU, investigators designed this study in order assess wether a high-fidelity based ICU-nurses education program would improve the outcome of CVVH sessions, compared to the conventional education program, proposed by the CVVH manufacturer.

ReferenceCitation: Lemarie P, Husser Vidal S, Gergaud S, Verger X, Rineau E, Berton J, Parot-Schinkel E, Hamel JF, Lasocki S. High-Fidelity Simulation Nurse Training Reduces Unplanned Interruption of Continuous Renal Replacement Therapy Sessions in Critically Ill Patients: The SimHeR Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):121-128. doi: 10.1213/ANE.0000000000003581.

family: Lemarie

full_name: Pierre Lemarie

family: Husser Vidal

full_name: Solenne Husser Vidal

given: Solenne

family: Gergaud

full_name: Soizic Gergaud

given: Soizic

family: Verger

full_name: Xavier Verger

given: Xavier

family: Rineau

full_name: Emmanuel Rineau

given: Emmanuel

family: Berton

full_name: Jerome Berton

given: Jerome

family: Parot-Schinkel

full_name: Elsa Parot-Schinkel

given: Elsa

family: Hamel

full_name: Jean-François Hamel

given: Jean-François

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

journal_name: Anesthesia & Analgesia

evidence: open (via free article)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health


title: SCHIZOBAT/DEPBAT : Characterization of the Motivational Deficit in Schizophrenia and Depression

acronym: SCHIZOBAT

summary: This research focuses on disorders of motivation, responsible for a disability that patients experience daily. It is a disorder that affects behavior, especially social. Mechanisms, which result in these disorders, are poorly understood. This ignorance is responsible for the lack of effective therapy. The investigators realize this work in order to better understand the motivational deficits. The objective of the study is to characterize the cognitive mechanisms of motivational deficits in schizophrenia and depression. To answer the question posed in the research, it is planned to include 35 people with schizophrenia, 35 people with depression and 70 heathy volunteers in the Hospital of Sainte-Anne .

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier St Anne

intervention_type: Behavioral


type: Other Identifier

title: Practices and Risk Factors for Weaning and Extubation Airway Failure in Adult Intensive Care Unit: a Multicenter Trial

acronym: Free-Rea

summary:
Airway management in intensive care unit (ICU) patients is challenging. Benefit risk ratio of extubation has to be daily assessed in intubated patients.

The investigators aimed to assess incidence and risk factors of airway failure after extubation procedure in critically ill patients in a prospective multicenter study.

ReferenceCitation: Marini JJ, Smith TC, Lamb VJ. External work output and force generation during synchronized intermittent mechanical ventilation. Effect of machine assistance on breathing effort. Am Rev Respir Dis. 1988 Nov;138(5):1169-79.

ReferenceCitation: Moschietto S, Doyen D, Grech L, Dellamonica J, Hyvernat H, Bernardin G. Transthoracic Echocardiography with Doppler Tissue Imaging predicts weaning failure from mechanical ventilation: evolution of the left ventricle relaxation rate during a spontaneous breathing trial is the key factor in weaning outcome. Crit Care. 2012 May 14;16(3):R81. doi: 10.1186/cc11339.

family: Moschietto

full_name: Sébastien Moschietto

given: Sébastien

family: Doyen

full_name: Denis Doyen

given: Denis

family: Grech

full_name: Ludovic Grech

given: Ludovic

family: Dellamonica

full_name: Jean Dellamonica

given: Jean

family: Hyvernat

full_name: Hervé Hyvernat

given: Hervé

family: Bernardin

full_name: Gilles Bernardin

given: Gilles

currency_apc_doaj: GBP

journal_name: Critical Care

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Montgomery AB, Holle RH, Neagley SR, Pierson DJ, Schoene RB. Prediction of successful ventilator weaning using airway occlusion pressure and hypercapnic challenge. Chest. 1987 Apr;91(4):496-9.

ReferenceCitation: Epstein SK, Ciubotaru RL. Independent effects of etiology of failure and time to reintubation on outcome for patients failing extubation. Am J Respir Crit Care Med. 1998 Aug;158(2):489-93.

ReferenceCitation: Witt NJ, Zochodne DW, Bolton CF, Grand'Maison F, Wells G, Young GB, Sibbald WJ. Peripheral nerve function in sepsis and multiple organ failure. Chest. 1991 Jan;99(1):176-84.

ReferenceCitation: Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62.

ReferenceCitation: Annane D, Sébille V, Charpentier C, Bollaert PE, François B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troché G, Chaumet-Riffaud P, Bellissant E. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002 Aug 21;288(7):862-71. Erratum in: JAMA. 2008 Oct 8;300(14):1652. Chaumet-Riffaut, Philippe [corrected to Chaumet-Riffaud, Philippe].

ReferenceCitation: Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56.

ReferenceCitation: Epstein SK, Ciubotaru RL, Wong JB. Effect of failed extubation on the outcome of mechanical ventilation. Chest. 1997 Jul;112(1):186-92.

ReferenceCitation: Rothaar RC, Epstein SK. Extubation failure: magnitude of the problem, impact on outcomes, and prevention. Curr Opin Crit Care. 2003 Feb;9(1):59-66. Review.

ReferenceCitation: Francon D, Jaber S, Pean D, Bally B, Marciniak B. [Difficult extubation: extubation criteria and management of risk situations: question 6. Société Française d'Anesthésie et de Réanimation]. Ann Fr Anesth Reanim. 2008 Jan;27(1):46-53. doi: 10.1016/j.annfar.2007.10.026. Epub 2007 Dec 31. French.

family: Francon

full_name: D. Francon

given: D.

family: Jaber

full_name: S. Jaber

given: S.

family: Pean

full_name: D. Pean

family: Bally

full_name: B. Bally

given: B.

family: Marciniak

full_name: B. Marciniak

journal_name: Annales Françaises d'Anesthésie et de Réanimation

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Extubation difficile : critères d’extubation et gestion des situations à risque

ReferenceCitation: Jaber S, Chanques G, Matecki S, Ramonatxo M, Vergne C, Souche B, Perrigault PF, Eledjam JJ. Post-extubation stridor in intensive care unit patients. Risk factors evaluation and importance of the cuff-leak test. Intensive Care Med. 2003 Jan;29(1):69-74. Epub 2002 Nov 22.

ReferenceCitation: Tanaka A, Isono S, Ishikawa T, Nishino T. Laryngeal reflex before and after placement of airway interventions: endotracheal tube and laryngeal mask airway. Anesthesiology. 2005 Jan;102(1):20-5.

ReferenceCitation: Jaber S, Jung B, Matecki S, Petrof BJ. Clinical review: ventilator-induced diaphragmatic dysfunction--human studies confirm animal model findings! Crit Care. 2011 Mar 11;15(2):206. doi: 10.1186/cc10023. Review.

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

title: Clinical review: Ventilator-induced diaphragmatic dysfunction - human studies confirm animal model findings!

ReferenceCitation: Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.

title: Rapidly Progressive Diaphragmatic Weakness and Injury during Mechanical Ventilation in Humans

ReferenceCitation: Jaber S, Quintard H, Cinotti R, Asehnoune K, Arnal JM, Guitton C, Paugam-Burtz C, Abback P, Mekontso Dessap A, Lakhal K, Lasocki S, Plantefeve G, Claud B, Pottecher J, Corne P, Ichai C, Hajjej Z, Molinari N, Chanques G, Papazian L, Azoulay E, De Jong A. Risk factors and outcomes for airway failure versus non-airway failure in the intensive care unit: a multicenter observational study of 1514 extubation procedures. Crit Care. 2018 Sep 23;22(1):236. doi: 10.1186/s13054-018-2150-6.

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

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


title: Prospective Observational Study About Pregnancy and Medically Assisted Conception in Rare Diseases

summary:
Rare diseases frequently affect women of childbearing age. Pregnancy in these women has become less rare, but remains associated with high levels of complications. One obstacle to their optimal management during pregnancy is that there are no prospective studies of pregnancy during rare diseases and several connective tissue diseases. As a consequence, the management of these pregnancies is non-standardised in terms of treatment, monitoring (frequency of consultations, laboratory tests and ultrasound), and organisation of care.

Moreover, although these women (all diseases combined) are frequently exposed to medications potentially incompatible with pregnancy, little is known about the frequency of these exposures and especially their consequences to mother and child.

For these reasons, researchers and clinicians from different specialties created an interdisciplinary research group on pregnancy and rare diseases (GR2), intended to improve the management of these patients' pregnancies. Using a single computer server, the investigators plan to set up a large prospective study of pregnancies in patients with rare diseases: various forms of myositis, lupus, antiphospholipid syndrome, Sjogren syndrome, scleroderma, and inflammatory rheumatic diseases. The investigators objective is to analyse the complications of pregnancies in women with rare diseases and then to improve their management and their quality of life.

status: Recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

status_simplified: Ongoing


title: Assessment of Lung Involvement in Cystic Fibrosis Patients Using 1.5T MR Imaging With Ultrashort Echo Time (UTE) Pulse Sequences

acronym: MucoIRM

summary: Non-invasive assessment of lung involvement is a crucial issue for the follow-up of cystic fibrosis patients. Currently, CT is the method of reference to evaluate and quantify the lung morphological changes in cystic fibrosis adults but it remains a radiation-based technique. MRI with ultrashort echo time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. The investigators' objective is to evaluate cystic fibrosis lung involvement using CT and MRI-UTE, and to test the agreement between both techniques.

ReferenceCitation: Benlala I, Point S, Leung C, Berger P, Woods JC, Raherison C, Laurent F, Macey J, Dournes G. Volumetric quantification of lung MR signal intensities using ultrashort TE as an automated score in cystic fibrosis. Eur Radiol. 2020 Oct;30(10):5479-5488. doi: 10.1007/s00330-020-06910-w. Epub 2020 May 15.

family: Benlala

full_name: Ilyes Benlala

given: Ilyes

family: Point

full_name: Sophie Point

given: Sophie

family: Leung

full_name: Cédric Leung

given: Cédric

family: Berger

full_name: Patrick Berger

given: Patrick

family: Woods

full_name: Jason C. Woods

given: Jason C.

family: Raherison

full_name: Chantal Raherison

given: Chantal

family: Laurent

full_name: François Laurent

given: François

family: Macey

full_name: Julie Macey

given: Julie

family: Dournes

full_name: Gaël Dournes

given: Gaël

journal_name: European Radiology

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

lead_sponsor: University Hospital, Bordeaux


title: Accuracy of Point-of-Care Measurement of Electrolytes, Glucose, Hemoglobin and Hematocrit With the RapidPoint 500 Blood Gas Analyser

acronym: (POCREA)

summary: ICU patients are at high risk of ionic or metabolic disturbances during the course of their critical illness. Some of these disturbances might be life-threatening and require rapid response from physicians. Point-of-Care determination of electrolytes, glucose, hemoglobin and hematocrit ensures early detection (within 1 minute) of abnormal values and allows rapid and appropriate therapy. This technology has largely improved the quality of care in ICU. However, the accuracy of the measurement of those parameters had to be close enough to the reference method, usually perfomed in the central lab but time consuming. Recently, a novel generation of blood gas analyser has been released. Among them, the RapidPoint 500 is mounted with a 28-day cartridge which provides automatic calibrations and quality controls several times a day. Such a technology dramatically decreases the need for labs technical interventions. To date, there is no data reporting the accuracy of this device. Therefore, the investigators' aim is to compare the accuracy of the RapidPoint 500 with a reference measurement performed at the central laboratory (Beckman&Coulter AU5800 for electrolytes and Beckman&Coulter DXH for hemoglobin).

ReferenceCitation: Ehrmeyer SS, Laessig RH, Leinweber JE, Oryall JJ. 1990 Medicare/CLIA final rules for proficiency testing: minimum intralaboratory performance characteristics (CV and bias) needed to pass. Clin Chem. 1990 Oct;36(10):1736-40.

ReferenceCitation: Clinical and Laboratory Standards Institute (CLSI). Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Third Edition. CLSI document EP9-A3 (ISBN 1-56238-887-8). Wayne, Pennsylvania, USA, 2013.

lead_sponsor: Hôpital Européen Marseille

location_facility: Service de REANIMATION, HOPITAL EUROPEEN MARSEILLE


title: Assessment the Dosage of Troponin T Hypersensitive Dosage in a Patient Population Hemodialysis and Peritoneal Dialysis (ECHOTnT)

acronym: ECHOTnT

summary:
"Troponin T (TnT) is a component of the contractile apparatus of the striated musculature. Although the function of TnT is the same in all striated muscles found in the heart to form a TNT (cardiac TnT) differing significantly TnT of the skeletal muscles. Because of its high tissue specificity, cardiac TnT is a specific marker and highly sensitive of myocardial injury.

Asymptomatic elevations of troponins is frequently found in patients with chronic renal failure in stage V, which present no clinical signs of acute or electrical myocardial injury.

Many studies have been conducted in recent years to explain the origin and clinical significance of this elevation, but the results are controversial: cardiac dysfunction, left ventricular hypertrophy or chronic inflammation.

Besides the effect of the dialysis session was evaluated on this biological parameter in different studies which together do not find Impact hemodialysis session on the value of troponin Achieving dosages rate hypersensitive serum troponin T in a dialysis population, will:

to determine the evolution of TnT in time and what are the characteristics of the patients for whom this rate varies
to know what its evolution during the session,
to identify if possible the criteria that are responsible for the variation in the direction of increasing and / or its reduction
and to characterize patients whose base rate is higher than the 99 percentile in the absence of clinical symptoms which could lead to establish reference population for this specific normal values. The Purpose of this study is to evaluate the serum troponin T in a hypersensitive dialysis population and verify what is the influence of the hemodialysis session, the session parameters and intradialytic events on changes in serum troponin T hypersensitive after a hemodialysis session. "

lead_sponsor: Nantes University Hospital


title: The Official Title is in French: Microbiote, Acides Biliaires et Athérome Coronaire (MABAC)

acronym: MABAC

summary:
The purpose of this study is to describe the composition of bile acids and the gut microbiota comparing two populations: patients with coronary atheroma and the healthy subjects.

Our hypothesis is based on the demonstration of the anti atherogenic and anti inflammatory effect of certain bile acids, and the role of the gut microbiota in the metabolic regulation.


title: Tolerance and Acceptability of Glibentek in Patients With Neonatale Diabetes Secondary to Mutations in K+-ATP Channels

acronym: NEOGLI

summary: The understanding of the molecular mechanisms of neonatal diabetes has deeply changed the therapy of patients carrying mutations in the K-ATP channel. Indeed, those patients are not treated anymore by insulin injections but by glibenclamide an oral anti-diabetic drug widely used in type 2 diabetes. Anyway, its galenic form (pills of 5 mg) is not suitable for children and difficult to administrate to infants or young children. The purpose of this study is to determine if a new galenic form of this durg is more suitable and as efficient as pills in children with neonatal diabetes.

ReferenceCitation: Busiah K, Drunat S, Vaivre-Douret L, Bonnefond A, Simon A, Flechtner I, Gérard B, Pouvreau N, Elie C, Nimri R, De Vries L, Tubiana-Rufi N, Metz C, Bertrand AM, Nivot-Adamiak S, de Kerdanet M, Stuckens C, Jennane F, Souchon PF, Le Tallec C, Désirée C, Pereira S, Dechaume A, Robert JJ, Phillip M, Scharfmann R, Czernichow P, Froguel P, Vaxillaire M, Polak M, Cavé H; French NDM study group. Neuropsychological dysfunction and developmental defects associated with genetic changes in infants with neonatal diabetes mellitus: a prospective cohort study [corrected]. Lancet Diabetes Endocrinol. 2013 Nov;1(3):199-207. doi: 10.1016/S2213-8587(13)70059-7. Epub 2013 Sep 6. Erratum in: Lancet Diabetes Endocrinol. 2013 Nov;1(3):e14.

ReferenceCitation: Pearson ER, Flechtner I, Njølstad PR, Malecki MT, Flanagan SE, Larkin B, Ashcroft FM, Klimes I, Codner E, Iotova V, Slingerland AS, Shield J, Robert JJ, Holst JJ, Clark PM, Ellard S, Søvik O, Polak M, Hattersley AT; Neonatal Diabetes International Collaborative Group. Switching from insulin to oral sulfonylureas in patients with diabetes due to Kir6.2 mutations. N Engl J Med. 2006 Aug 3;355(5):467-77.

ReferenceCitation: Babenko AP, Polak M, Cavé H, Busiah K, Czernichow P, Scharfmann R, Bryan J, Aguilar-Bryan L, Vaxillaire M, Froguel P. Activating mutations in the ABCC8 gene in neonatal diabetes mellitus. N Engl J Med. 2006 Aug 3;355(5):456-66.

ReferenceCitation: Beltrand J, Baptiste A, Busiah K, Bouazza N, Godot C, Boucheron A, Djerada Z, Gozalo C, Berdugo M, Tréluyer JM, Elie C, Polak M; GLID-KIR study group. Glibenclamide oral suspension: Suitable and effective in patients with neonatal diabetes. Pediatr Diabetes. 2019 May;20(3):246-254. doi: 10.1111/pedi.12823. Epub 2019 Feb 21.

name: Pediatric diabetes and endocrinologyNecker Enfants Malades Hospital, Assistance Publique‐Hôpitaux de Paris Paris France

name: Paris Descartes Medical School –Sorbonne Paris Cité university Paris France

name: Inserm U1016Cochin Institute Paris France

name: Imagine Institute, Sorbonne Paris Cité university Paris France

name: Centre deréférence national des maladies rares de la sécrétion d'insuline et de lasensibilité à l'insuline, PRISIS, Saint‐Antoine hospital Paris France

family: Beltrand

full_name: Jacques Beltrand

given: Jacques

name: Clinical research unit Paris Descartes Necker Cochin, Necker Enfants Malades HospitalAssistance Publique‐Hôpitaux de Paris Paris France

family: Baptiste

full_name: Amandine Baptiste

given: Amandine

family: Busiah

full_name: Kanetee Busiah

given: Kanetee

family: Bouazza

full_name: Naim Bouazza

given: Naim

family: Godot

full_name: Cecile Godot

given: Cecile

family: Boucheron

full_name: Adeline Boucheron

given: Adeline

name: CHU Reims, Maison Blanche hospitalLaboratoire de Pharmacologie ‐Toxicologie Reims France

family: Djerada

full_name: Zoubir Djerada

given: Zoubir

family: Gozalo

full_name: Claire Gozalo

given: Claire

name: Inserm U1138, Cordeliers research centrePierre et Marie Curie university Paris France

family: Berdugo

full_name: Marianne Berdugo

given: Marianne

name: Clinical pharmacology unit, AP‐HPCochin‐Broca‐Hôtel‐Dieu hospital Paris France

family: Tréluyer

full_name: Jean‐Marc Tréluyer

given: Jean‐Marc

family: Elie

full_name: Caroline Elie

given: Caroline

family: Polak

full_name: Michel Polak

given: Michel

journal_name: Pediatric Diabetes

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

location_facility: Hôpital Universitaire Necker Enfants Malades

intervention_type: Drug


title: A Randomized Trial of Delayed Radiotherapy in Patients With Newly Diagnosed 1p/19q Codeleted Anaplastic Oligodendroglial Tumors: the POLCA Trial.

acronym: POLCA

summary: Patients with 1p/19q-codeleted anaplastic gliomas treated with RT + PCV are at risk of neurocognitive deterioration. Treating these patients with PCV alone (could reduce the risk of neurocognitive deterioration without impairing overall survival.

ipd_sharing: No


title: Co-operative Behavior and Decision-making in Frontal Lobe Epilepsy

summary:
Epilepsy is a frequent neurological disorder with about a third of patients having seizures despite treatment. At least some of these seizures can be linked to a low compliance and therapy adherence of patients. Compliance is defined as "the extent to which a person's behavior (in terms of taking medication, following diets, or executing life style changes) coincides with medical or health advice". Therapy adherence of patients suffering from epilepsy is low with reported rates between 30 and 50%, although adherence to anticonvulsive drug therapy is critical for effective disease management and low therapy adherence is associated to higher mortality in epilepsy. The reasons for low therapy adherence are still a matter of research. Some known factors influencing compliance in epilepsy are related to its chronic nature, but others seem to lie in a complex interaction between psychiatric comorbidity and an impairment of neural systems underlying behavior. Furthermore, therapy adherence rests a variable difficult to measure, especially in epileptic patients where classical tools such as questionnaires and electronic monitoring devices have been shown to be imprecise. It has been argued that the term 'compliance' should be replaced by 'co-operative behavior' and non-compliance can therefore be interpreted as troubled co-operative behavior. This behavioral approach offers the potential of using tools and methods of the latest developments in behavioral neuroscience. Neuroeconomics, a scientific field on the border of psychology, economics and neuroscience, has used economic game paradigms in order to operationalize cooperative behavior and to identify several brain areas by functional brain imaging that have been linked to social co-operative behavior. The majority of these brain areas are located in the frontal cortex [ventromedial frontal/orbitofrontal cortex, and rostral anterior cingulate cortex. Epilepsies originating in the frontal lobe are subsumed under the term "frontal lobe epilepsy" (FLE) and represent 20-30% of all partial seizures and 25% of all refractory focal epilepsies referred to epilepsy surgery.

The investigator's project plans to study compliance and cooperative behavior of patients suffering from frontal lobe epilepsies through a neuroeconomic approach by (1) comparing the behavior of these patients in the prisoners' dilemma game to the behavior of age-, gender-, and education-matched healthy controls, (2) correlation of game behavior to brain activation measured by functional magnetic resonance imaging in both patients and healthy controls and (3) studying the link between cooperative behavior to compliance captured by pill counts and questionnaires.

intervention_type: Radiation


title: COmorbidities and EDucation in SpondyloArthritis Study (COMEDSPA) Evaluation of Standardized Follow-up in Axial Spondyloarthritis

acronym: COMEDSPA

summary:
Giving both the gap existing between the current recommendations to prevent/detect comorbidities and the clinical practice in patients suffering from spondyloarthritis and also the specificity of some recommendations to rheumatic diseases, it seems logical to check these recommendations in a rheumatologic "environment".

This study with its two parts should be able to demonstrate:

The importance of a systematic evaluation of comorbidities in Spondyloarthritis,
The utility of a nurse-led program of self-assessment and self-management of the disease

primary_purpose: Other

ReferenceCitation: Molto A, Gossec L, Poiraudeau S, Claudepierre P, Soubrier M, Fayet F, Wendling D, Gaudin P, Dernis E, Guis S, Pouplin S, Ruyssen A, Chales G, Mariette X, Beauvais C, Combe B, Flipo RM, Richette P, Chary-Valckenaere I, Saraux A, Sibilia J, Schaeverbeke T, Dougados M. Evaluation of the impact of a nurse-led program of systematic screening of comorbidities in patients with axial spondyloarthritis: The results of the COMEDSPA prospective, controlled, one year randomized trial. Semin Arthritis Rheum. 2020 Aug;50(4):701-708. doi: 10.1016/j.semarthrit.2020.05.012. Epub 2020 May 27.

family: Molto

full_name: Anna Molto

given: Anna

family: Gossec

full_name: Laure Gossec

given: Laure

family: Poiraudeau

full_name: Serge Poiraudeau

given: Serge

family: Claudepierre

full_name: Pascal Claudepierre

given: Pascal

family: Soubrier

full_name: Martin Soubrier

given: Martin

family: Fayet

full_name: Françoise Fayet

given: Françoise

family: Wendling

full_name: Daniel Wendling

given: Daniel

family: Gaudin

full_name: Philippe Gaudin

given: Philippe

family: Dernis

full_name: Emmanuelle Dernis

given: Emmanuelle

family: GUIS

full_name: Sandrine GUIS

given: Sandrine

family: Pouplin

full_name: Sophie Pouplin

given: Sophie

family: Ruyssen

full_name: Adeline Ruyssen

family: Chales

full_name: Gerard Chales

given: Gerard

family: Mariette

full_name: Xavier Mariette

given: Xavier

family: Beauvais

full_name: Catherine Beauvais

given: Catherine

family: Combe

full_name: Bernard Combe

given: Bernard

family: Flipo

full_name: René-Marc Flipo

given: René-Marc

family: Richette

full_name: Pascal Richette

family: Chary-Valckenaere

full_name: Isabelle Chary-Valckenaere

given: Isabelle

family: Saraux

full_name: Alain Saraux

given: Alain

family: Sibilia

full_name: Jean Sibilia

given: Jean

family: Schaeverbeke

full_name: Thierry Schaeverbeke

given: Thierry

family: Dougados

full_name: Maxime Dougados

given: Maxime


lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

acronym: BBSUCROSE

type: EudraCT Number

source: euctr

title: Autonomic Nervous System Reactivity of the Newborn After a Nociceptive Stress: Interest of Sucrose and Non-nutritive Sucking : A Controlled Randomized Single-center Study.

summary:
The management of the pain is a constant care concern in neonatal and maternity units. Many studies show an interest in the use of sugar solutions to reduce nociception during painful events in infants. However, these studies are based mainly on behavioral observation of the newborn but intrinsic mechanisms of analgesic power are not clearly understood for sucrose solutions.

Our hypothesis is that the analgesic mechanism of sucrose solutions in infants involves a subcortical reactivity notably by action via the brain stem. To explore the intensity of pain and evaluate the subcortical activity, we will use 1) the analysis of heart rate variability (frequency indices whose HFnu) as a peripheral witness of subcortical functioning of the autonomic nervous system 2) electroacoustic analysis of the intensity of crying baby, 3) a composite pain score (DAN score).


title: Correlation Between the Pulse Pressure / Heart Rate Ratio Variations and Stroke Volume Variations During Fluid Challenge.

acronym: ΔPP/HRvsΔSV

summary:
In high perioperative risk patients, guidelines suggest intraoperative haemodynamic optimization by measurement of stroke volume (SV) to guide fluid resucitation.This strategy requires an invasive monitoring and learning. Some studies tried to find SV surrogates based on haemodynamic usual parameters. In an experimental hemorrhagic shock, SV was correlated to the pulse pressure (PP) / heart rate (HR) ratio.

The investigators hypothesized that SV variations (ΔSV) would be correlated to the PP/HR ratio variations (ΔPP / HR) during fluid challenge, and ΔPP / HR would be able to detect a ΔSV greater than 10%.

lead_sponsor: University Hospital, Caen


lead_sponsor: University Hospital, Limoges

acronym: Metvix®, Natural Daylight Photodynamic Therapy, Actinic keratosis

title: Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses

summary: The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy in subjects with mild actinic keratoses (intra-individual comparison)


title: Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response

summary: This study will follow-up immune cell populations, secreted factors and released nanovesicles in the blood before, during and after high dose radiation therapy which should give new information of the efficacy of the hypofractionated high dose radiation therapy and a rationale for adjuvant immunotherapy.

status: Terminated

lead_sponsor: Centre Oscar Lambret


title: High Flow Oxygen Therapy in Patients Suffering From Chronic Obstructive Pulmonary Disease Exacerbation: Effects and Mechanisms of Action

acronym: Oh BPCO

summary:
Acute exacerbation of chronic obstructive pulmonary disease (COPD) is associated with poor outcome, especially when intubation is required, thus underlining the importance of optimizing non-invasive ventilatory support to avoid intubation. Practically, because of treatment intolerance, non-invasive ventilation (NIV) cannot be administered 24-hour a day for a long period of time and alternative solutions must be found to deliver oxygen as efficiently as possible to allow NIV interruptions. High flow humidified oxygen therapy (HFHO) consists of delivering a high-flow (15-60 L/minute) heated air-oxygen mixture (FIO2 21-100%) through a dedicated nasal cannula and can be interesting in this context. This well tolerated technique improves oxygenation and decreases respiratory rate and dyspnea in patients suffering from acute hypoxemic respiratory failure. In chronic COPD patients, using HFHO can decrease respiratory rate and PaCO2. In COPD exacerbation, using HFHO can conceptually be interesting. First, the high air-oxygen flow delivered well matches the patient's inspiratory demand and should decrease the work of breathing. Second, as during HFHO a high flow is continuously delivered in the airways, a wash-out of the anatomical dead space should occur and CO2 clearance should be enhanced. Despite this strong physiological rational for the use of HFHO in patients suffering from COPD exacerbation, the effects of using HFHO instead of conventional oxygenotherapy in combination with non-invasive ventilation (NIV) in this context has never been explored.

The main objective of the study is to explore the effects of using HFHO in combination with NIV in acute COPD exacerbation and to assess the underlying mechanisms of action.

lead_sponsor: University Hospital, Angers


title: Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis

acronym: PASEO

summary:
Hand osteoarthritis is a common phenotype of osteoarthritis which affects about 70 % of the elderly population. Usually considered as a minor illness, it nevertheless leads to an important functional impairment. The mechanism of this disease is still poorly known. Furthermore there are 2 different subtypes : erosive and non erosive hand osteoarthritis from which mechanisms may differ.

Methods:

This is a cross-sectional study recruiting patients with hand osteoarthritis addressed in consultation of rheumatology and plastic surgery in Rouen University Hospital.

Two groups of patients will be studied: 20 patients with non erosive subtype of hand osteoarthritis and 20 patients with erosive subtype of hand osteoarthritis.

A clinical evaluation of hand osteoarthritis will be performed. Blood sample for proteomic analysis will be taken. Hand MRI and Bone Mineral Analyser will be performed.

lead_sponsor: University Hospital, Rouen


title: Screening for Social Weaknesses and Coordination Course of Cancer Patients: A New Approach by an Expert System IT

acronym: DEFCOCANCERO

summary:
The main objective of the study is to validate a methodology with Psychometric tool to measure levels of patients social fragility.

This tool will be dematerialized on a tablet. The answers will be then processed by a decision support algorithm, which automatically send an alert to detection of social fragility of the patient to the nurse navigators.

primary_purpose: Screening


title: Patients Navigator for Organized Colorectal Cancer Screening in Underserved Population

acronym: COLONAV

summary: The main objective is to evaluate the impact of the recruitment and training of a peer-navigator on the participation rate of colorectal cancer screening among underserved area. The role of the navigator is to establish an intervention culturally-tailored to the inhabitants in order to promote the Fecal Occult Blood test (FOBT) and accompany the inhabitants to complementary exams, if needed.

ReferenceCitation: Allary C, Bourmaud A, Tinquaut F, Oriol M, Kalecinski J, Dutertre V, Lechopier N, Pommier M, Benoist Y, Rousseau S, Regnier V, Buthion V, Chauvin F. ColoNav: patient navigation for colorectal cancer screening in deprived areas - Study protocol. BMC Cancer. 2016 Jul 7;16:416. doi: 10.1186/s12885-016-2469-9.

family: Allary

full_name: C. Allary

given: C.

family: Bourmaud

full_name: A. Bourmaud

given: A.

family: Tinquaut

full_name: F. Tinquaut

given: F.

family: Oriol

full_name: M. Oriol

given: M.

family: Kalecinski

full_name: J. Kalecinski

given: J.

family: Dutertre

full_name: V. Dutertre

given: V.

family: Lechopier

full_name: N. Lechopier

given: N.

family: Pommier

full_name: M. Pommier

family: Benoist

full_name: Y. Benoist

given: Y.

family: Rousseau

full_name: S. Rousseau

given: S.

family: Regnier

full_name: V. Regnier

family: Buthion

full_name: V. Buthion

family: Chauvin

full_name: F. Chauvin

journal_name: BMC Cancer

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

title: ColoNav: patient navigation for colorectal cancer screening in deprived areas – Study protocol

location_facility: Institut de cancérologie Lucien Neuwirth


title: Consequences of Aging and Dirtying of Microphones on the Performances of Cochlear Implants. Influence of Signal Coding

summary: Cochlear implant microphones are subject to aging and dirtying. The evolution may affect their efficiency. Several signal coding strategies are used in cochlear implants and their behaviour may be more or less affected by the aging process. In this work the investigators wish to assess this phenomenon.

location_facility: Pavillon ORL (U) - Hôpital Edouard Herriot


title: Embolization Procedures in the Peripheral Vasculature Using the Magellan™ Robotic System

summary:
The purpose of this prospective study is to gather procedural use and safety data on the initial use of the Magellan Robotic System with the Magellan Robotic Catheter 6 Fr, Vascular Accessories 6 Fr and Microcatheter Driver This study will focus on, but not be limited to, endovascular embolization procedures in the peripheral vascular, for example, embolization of the splenic and hepatic arteries, uterine arterial embolization (UAE), prostatic arterial embolization (PAE), and trans-arterial chemoembolization (TACE).

The data will be analyzed for medical education, societal presentation and/or publication by the investigator.

lead_sponsor: Hansen Medical


title: Interventional, Randomised, Double-blind, Placebo- and Positive Controlled, Single-dose, Cross-over Study Investigating the Effect of Idalopirdine on Cardiac Repolarisation in Healthy Men

summary: To evaluate the effect of idalopirdine (120 and 360 mg) on cardiac repolarisation in healthy men.

lead_sponsor: H. Lundbeck A/S


title: Evaluation of an Iris Dilatation Ring in Cataract Surgery

acronym: ADICC-ID

summary:
During cataract surgery, it is necessary to dilate the iris in order to remove the crystalline lens and position the implant. The diameter of the optical implant being 6 mm, in case of capsulorhexis crystalline access 5.5 mm, the expansion should be at least 6 mm.

At pre-operative consultation, the iris is always dilated by instillation of eye drops and measured at the slitlamp. For patients with an inadequate dilation, the intervention requires the use of a mechanical dilatation device.

This study aims to assess the value of an alternative dilatation ring to Malyugin ring, which can be inserted and removed through an incision of less than 2 mm in diameter, due to its size smaller than that of the Malyugin ring.

Our hypothesis is that this Bhattacharjee ring ensures sufficient and stable iris dilation during surgery, enabling implant placement in good conditions.

ReferenceCitation: Salviat F, Febbraro JL, Zuber K, Yavchitz A, Moran S, Gatinel D. Evaluation of a uniplanar pupil expansion ring in small-pupil cataract surgery: a feasibility study. Int Ophthalmol. 2021 Oct 16. doi: 10.1007/s10792-021-02065-9. [Epub ahead of print]

family: Salviat

full_name: Flore Salviat

given: Flore

family: Febbraro

full_name: Jean-Luc Febbraro

given: Jean-Luc

family: Zuber

full_name: Kevin Zuber

given: Kevin

family: Yavchitz

full_name: Amélie Yavchitz

given: Amélie

family: Moran

full_name: Sarah Moran

given: Sarah

family: Gatinel

full_name: Damien Gatinel

given: Damien

journal_name: International Ophthalmology

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rotchschild


title: Volume Restoration of Plantar Pad With a Hyaluronic Acid Dermal Filler in Treatment of Metatarsalgia of Forefeet Further Use of High Heel Shoes

acronym: ELFE

summary: Aim of this study is to evaluate the decrease of plantar pain of forefeet due to restoration of plantar pad tissue density and of cushioning function with an hyaluronic acid dermal filler as mechanical-supplementation in subjects with metatarsalgia further use of high heel shoes

lead_sponsor: Galderma R&D


title: Extended Follow Up of the Mainritsan 2 Study. Comparison Between a Long Term and a Conventional Maintenance Treatment With Rituximab: a Placebo- Controlled Randomized Trial

summary:
MAINRITSAN study compared Rituximab and azathioprine as maintenance therapy for ANCA-associated vasculitides. In this study, Rituximab (5 infusions at D1, D15, M6, M12, M18) was superior to azathioprine (2 mg/kg/day) to prevent relapses of AAV 28 months after the inclusion (Guillevin et al. NEJM 2014). Nevertheless, in the follow-up study of MAINRITSAN, up to 30% of patients experienced a relapse 38 months after the last rituximab infusion (unpublished data). Right now, no randomized controlled study has been carried in order to evaluate the best duration of the maintenance treatment with rituximab.

The investigators objective is to evaluate the efficacy of a long term rituximab treatment to prevent relapses of ANCA-associated vasculitis in patients in remission after a first phase of rituximab maintenance treatment.

The investigators will conduct a randomized placebo-controlled trial of a long term rituximab maintenance treatment (46 months) against a conventional maintenance treatment (18 months).

ReferenceCitation: Pagnoux C, Guillevin L; French Vasculitis Study Group; MAINRITSAN investigators. Rituximab or azathioprine maintenance in ANCA-associated vasculitis. N Engl J Med. 2015 Jan 22;372(4):386-7. doi: 10.1056/NEJMc1414728.

ReferenceCitation: Charles P, Perrodeau É, Samson M, Bonnotte B, Néel A, Agard C, Huart A, Karras A, Lifermann F, Godmer P, Cohen P, Hanrotel-Saliou C, Martin-Silva N, Pugnet G, Maurier F, Sibilia J, Carron PL, Gobert P, Meaux-Ruault N, Le Gallou T, Vinzio S, Viallard JF, Hachulla E, Vinter C, Puéchal X, Terrier B, Ravaud P, Mouthon L, Guillevin L; French Vasculitis Study Group. Long-Term Rituximab Use to Maintain Remission of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: A Randomized Trial. Ann Intern Med. 2020 Aug 4;173(3):179-187. doi: 10.7326/M19-3827. Epub 2020 Jun 2.

name: Cochin Hospital, Paris Descartes University, and Institut Mutualiste Montsouris, Paris, France (P.C.)

family: Charles

full_name: Pierre Charles

given: Pierre

name: Centre d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Université Paris Descartes, Sorbonne Paris Cité INSERM Unité 1153, Paris, France (É.P., P.R.)

family: Perrodeau

full_name: Élodie Perrodeau

given: Élodie

name: Centre Hospitalier Universitaire de Dijon, INSERM, UMR 1098, University of Bourgogne Franche-Comté, FHU INCREASE, Dijon, France (M.S., B.B.)

family: Samson

full_name: Maxime Samson

family: Bonnotte

full_name: Bernard Bonnotte

given: Bernard

name: CRTI UMR 1064, INSERM, Université de Nantes, and Centre Hospitalier Universitaire Nantes, Nantes, France (A.N.)

family: Néel

full_name: Antoine Néel

given: Antoine

name: Centre Hospitalier Universitaire Nantes, Nantes, France (C.A.)

family: Agard

full_name: Christian Agard

given: Christian

name: Centre Hospitalier Universitaire de Toulouse, Toulouse, France (A.H., G.P.)

family: Huart

full_name: Antoine Huart

name: Hôpital Européen Georges-Pompidou, Université Paris Descartes, Paris, France (A.K.)

family: Karras

full_name: Alexandre Karras

given: Alexandre

name: Centre Hospitalier de Dax, Dax, France (F.L.)

family: Lifermann

full_name: François Lifermann

given: François

name: Centre Hospitalier Bretagne Atlantique de Vannes, Vannes, France (P.G.)

family: Godmer

full_name: Pascal Godmer

given: Pascal

name: Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., B.T., L.M., L.G.)

family: Cohen

full_name: Pascal Cohen

name: Hôpital la Cavale Blanche, Centre Hospitalier Universitaire Brest, Brest, France (C.H.)

family: Hanrotel-Saliou

full_name: Catherine Hanrotel-Saliou

given: Catherine

name: Centre Hospitalier Universitaire de Caen, Caen, France (N.M.)

family: Martin-Silva

full_name: Nicolas Martin-Silva

given: Nicolas

family: Pugnet

full_name: Grégory Pugnet

given: Grégory

name: Hôpitaux Privés de Metz, Metz, France (F.M.)

family: Maurier

full_name: François Maurier

name: Hôpital de Hautepierre, Centre Hospitalier Universitaire de Strasbourg, Strasbourg, France (J.S.)

family: Sibilia

full_name: Jean Sibilia

given: Jean

name: Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, France (P.C.)

family: Carron

full_name: Pierre-Louis Carron

given: Pierre-Louis

name: Clinique Rhône Durance, Avignon, France (P.G.)

family: Gobert

full_name: Pierre Gobert

name: Centre Hospitalier Universitaire Jean-Minjoz, Besançon, France (N.M.)

family: Meaux-Ruault

full_name: Nadine Meaux-Ruault

given: Nadine

name: Centre Hospitalier Universitaire de Rennes, Rennes, France (T.L.)

family: Le Gallou

full_name: Thomas Le Gallou

given: Thomas

name: Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France (S.V.)

family: Vinzio

full_name: Stéphane Vinzio

given: Stéphane

name: Centre Hospitalier Universitaire de Bordeaux, Pessac, France (J.V.)

family: Viallard

full_name: Jean-François Viallard

given: Jean-François

name: Centre Hospitalier Universitaire de Lille, Lille, France (E.H.)

family: Hachulla

full_name: Eric Hachulla

title: Long-Term Rituximab Use to Maintain Remission of Antineutrophil Cytoplasmic Antibody–Associated Vasculitis


title: Assessment of Feasibility and Benefit of the Use of Less Than 3 Millimeter Diameter's Instruments Compared to Standard Size Instruments in Laparoscopic Hysterectomy: a Randomized Single-center Comparative Study

summary: Hysterectomy for benign uterine disease is often intended to young perimenopausal patients. Currently laparoscopic hysterectomy is commonly used in this indication. We are wondering if decreasing the diameter of laparoscopic instruments could reduce postoperative pain and improve esthetic result without increasing operative time. The purpose of the study is to improve patients' care.

lead_sponsor: University Hospital, Clermont-Ferrand


title: A Prospective Randomized Controlled Study Comparing the Efficacy of Pelvic Floor Muscle Training and Oral Duloxetine in the Recovery of Continence After Robotic Assisted Radical Prostatectomy

summary:
Objectives:

Primary: Comparison of proportion of patient achieving continence between the four arms at 6 months.

Secondary:

Comparison of time to achieve continence between the four arms.
Comparison of urinary symptoms and quality of life improvement between the four arms.
Assessment of adverse events in Duloxetine arms.

Primary outcome/ time frame: Proportion of patient achieving continence at 6 months. Continence is defined as "using no pad"or "only security pad".

Secondary outcome:

time to achieve continence
Quality of life tested in relation to incontinence according to Visual Analog Scale (VAS) and King's Health Questionnaire (KQH).
Urinary symptoms measured with International Prostate Symptom Score (IPSS).

No. of subjects entered: 300 patients informed and included, 240 patients will be randomized.

Statistical methods

Proportion of patients who achieve continence and time to achieve continence will be compared between the four arms.
Comparison of quality of life outcomes between the four arms
Comparison of clinical variables that can affect the primary/secondary outcome - univariate and multivariate analysis (ITT).

lead_sponsor: Institut Mutualiste Montsouris


title: Impact of Intravenous Exenatide Versus Insulin on Quality of Life in Cardiac Surgery Patients: an Ancillary Study of the ExSTRESS Phase II/III Clinical Trial

acronym: ExeQOL

summary:
A diminution of quality of life is often reported by patients after coronary artery bypass graft (CABG) surgery. A part of this diminution could be explain by postoperative left ventricular (LV) dysfunction.

Exenatide (Byetta®) is an incretin mimetic, characterized by an anti-hyperglycemic effect that depends on the blood glucose level. Recent data have suggested that exenatide could improve LV function by an inotropic effect in patients suffering from cardiogenic shock or from congestive heart failure. Moreover, patients suffering from congestive heart failure reported a better quality of life when they were treated with exenatide compared to placebo.

The investigators hypothesize that perioperative exenatide infusion could improve postoperative quality of life in CABG surgery patients.

ReferenceCitation: Goldberg PA, Sakharova OV, Barrett PW, Falko LN, Roussel MG, Bak L, Blake-Holmes D, Marieb NJ, Inzucchi SE. Improving glycemic control in the cardiothoracic intensive care unit: clinical experience in two hospital settings. J Cardiothorac Vasc Anesth. 2004 Dec;18(6):690-7.

ReferenceCitation: Studer C, Sankou W, Penfornis A, Pili-Floury S, Puyraveau M, Cordier A, Etievent JP, Samain E. Efficacy and safety of an insulin infusion protocol during and after cardiac surgery. Diabetes Metab. 2010 Feb;36(1):71-8. doi: 10.1016/j.diabet.2009.05.008. Epub 2010 Jan 25.

ReferenceCitation: Perneger TV, Leplège A, Etter JF, Rougemont A. Validation of a French-language version of the MOS 36-Item Short Form Health Survey (SF-36) in young healthy adults. J Clin Epidemiol. 1995 Aug;48(8):1051-60.

ReferenceCitation: Sokos GG, Nikolaidis LA, Mankad S, Elahi D, Shannon RP. Glucagon-like peptide-1 infusion improves left ventricular ejection fraction and functional status in patients with chronic heart failure. J Card Fail. 2006 Dec;12(9):694-9.

ReferenceCitation: Sokos GG, Bolukoglu H, German J, Hentosz T, Magovern GJ Jr, Maher TD, Dean DA, Bailey SH, Marrone G, Benckart DH, Elahi D, Shannon RP. Effect of glucagon-like peptide-1 (GLP-1) on glycemic control and left ventricular function in patients undergoing coronary artery bypass grafting. Am J Cardiol. 2007 Sep 1;100(5):824-9. Epub 2007 Jun 14.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Post operative intensive care unit of the cardiac surgery department


title: Study of the Mechanisms of the Arterial Calcification of the Members Subordinates in the Diabetes (Implication of the System RANK / RANKL / OSTEOPROTEGERINE)

acronym: DIACART

summary: The blood concentration of the protein RANKL could be predictive of the calcification of the leg arteries, which is a major complication occurring during diabetes. The objective of the DIACART study is to show that blood RANKL concentration predict the progression of calcification of the leg arteries in diabetic patients, independently of other cardiovascular risk factors.

ReferenceCitation: Bourron O, Phan F, Diallo MH, Hajage D, Aubert CE, Carlier A, Salem JE, Funck-Brentano C, Kemel S, Cluzel P, Redheuil A, Davaine JM, Massy Z, Mentaverri R, Bonnefont-Rousselot D, Gillery P, Jaisson S, Vermeer C, Lacorte JM, Bouziri N, Laroche S, Amouyal C, Hartemann A. Circulating Receptor Activator of Nuclear Factor kB Ligand and triglycerides are associated with progression of lower limb arterial calcification in type 2 diabetes: a prospective, observational cohort study. Cardiovasc Diabetol. 2020 Sep 18;19(1):140. doi: 10.1186/s12933-020-01122-4.

family: Bourron

full_name: Olivier Bourron

given: Olivier

family: Phan

full_name: Franck Phan

given: Franck

family: Diallo

full_name: Mamadou Hassimiou Diallo

given: Mamadou Hassimiou

family: Hajage

full_name: David Hajage

given: David

family: Aubert

full_name: Carole-Elodie Aubert

given: Carole-Elodie

family: Carlier

full_name: Aurélie Carlier

given: Aurélie

family: Salem

full_name: Joe-Elie Salem

given: Joe-Elie

family: Funck-Brentano

full_name: Christian Funck-Brentano

family: Kemel

full_name: Salim Kemel

given: Salim

family: Cluzel

full_name: Philippe Cluzel

given: Philippe

family: Redheuil

full_name: Alban Redheuil

given: Alban

family: Davaine

full_name: Jean-Michel Davaine

given: Jean-Michel

family: Massy

full_name: Ziad Massy

given: Ziad

family: Mentaverri

full_name: Romuald Mentaverri

given: Romuald

family: Bonnefont-Rousselot

full_name: Dominique Bonnefont-Rousselot

given: Dominique

family: Gillery

full_name: Philippe Gillery

family: Jaisson

full_name: Stéphane Jaisson

family: Vermeer

full_name: Cees Vermeer

given: Cees

family: Lacorte

full_name: Jean-Marc Lacorte

given: Jean-Marc

family: Bouziri

full_name: Nesrine Bouziri

given: Nesrine

family: Laroche

full_name: Suzanne Laroche

given: Suzanne

family: Amouyal

full_name: Chloé Amouyal

given: Chloé

family: Hartemann

full_name: Agnes Hartemann

given: Agnes

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

ReferenceCitation: Aubert CE, Liabeuf S, Amouyal C, Kemel S, Lajat-Kiss F, Lacorte JM, Halbron M, Carlier A, Salem JE, Funck-Brentano C, Perisic Matic L, Witasp A, Stenvinkel P, Phan F, Massy ZA, Hartemann A, Bourron O. Serum concentration and vascular expression of adiponectin are differentially associated with the diabetic calcifying peripheral arteriopathy. Diabetol Metab Syndr. 2019 Apr 29;11:32. doi: 10.1186/s13098-019-0429-7. eCollection 2019.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech


title: Analysis of Changes in Eating Behaviors and Physical Activity on Post Bariatric Surgery Patients and Their Family Members : Comparison Between Men and Women

acronym: SOCIOB

summary: The main objective of this study is to identify changes in eating behaviors and physical activity in patients after bariatric surgery and their family members living in same household: children aged between 11-17 years, spouse, parents, cohabitee or partner in a civil union.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Department of Nutrition, CHU Ambroise Paré


title: Cross Checking to Reduce Adverse Events Resulting From Medical Errors in the Emergency Department

acronym: Charmed

summary: Multicenter cluster randomized study to evaluate the reduction of the rate of severe medical errors with implementation of systematic cross checkings between emergency physician.

ReferenceCitation: Freund Y, Goulet H, Leblanc J, Bokobza J, Ray P, Maignan M, Guinemer S, Truchot J, Féral-Pierssens AL, Yordanov Y, Philippon AL, Rouff E, Bloom B, Cachanado M, Rousseau A, Simon T, Riou B. Effect of Systematic Physician Cross-checking on Reducing Adverse Events in the Emergency Department: The CHARMED Cluster Randomized Trial. JAMA Intern Med. 2018 Jun 1;178(6):812-819. doi: 10.1001/jamainternmed.2018.0607.

name: Emergency department, Hôpital Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris (APHP), Paris, France

family: Freund

full_name: Yonathan Freund

given: Yonathan

family: Goulet

full_name: Hélène Goulet

given: Hélène

name: Plateforme de recherche clinique (URC-CRC-CRB), Hôpital Saint-Antoine, APHP, Paris, France

family: Leblanc

full_name: Judith Leblanc

given: Judith

name: Emergency department, Hôpital Cochin, APHP, Paris, France

family: Bokobza

full_name: Jérôme Bokobza

given: Jérôme

name: Emergency department, Hôpital Tenon, APHP, Paris, France

family: Ray

full_name: Patrick Ray

given: Patrick

name: Emergency department, University Grenoble Alps, Hôpital Michallon, Grenoble, France

family: Maignan

full_name: Maxime Maignan

given: Maxime

name: Emergency department, Hôpital Avicenne, APHP, Paris, France

family: Guinemer

full_name: Sabine Guinemer

given: Sabine

name: Emergency department, Hôpital Lariboisière, APHP, Paris, France

family: Truchot

full_name: Jennifer Truchot

given: Jennifer

name: Emergency department, Hôpital Européen Georges Pompidou, APHP, Paris, France

family: Féral-Pierssens

full_name: Anne-Laure Féral-Pierssens

given: Anne-Laure

name: Emergency department, Hôpital Saint-Antoine, APHP, Paris, France

family: Yordanov

full_name: Youri Yordanov

given: Youri

family: Philippon

full_name: Anne-Laure Philippon

family: Rouff

full_name: Edwin Rouff

given: Edwin

name: Emergency department, Barts Health NHS Trust, London, England.

family: Bloom

full_name: Ben Bloom

given: Ben

family: Cachanado

full_name: Marine Cachanado

given: Marine

family: Rousseau

full_name: Alexandra Rousseau

given: Alexandra

family: Simon

full_name: Tabassome Simon

given: Tabassome

family: Riou

full_name: Bruno Riou

given: Bruno

journal_name: JAMA Internal Medicine

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

ReferenceCitation: Freund Y, Rousseau A, Berard L, Goulet H, Ray P, Bloom B, Simon T, Riou B. Cross-checking to reduce adverse events resulting from medical errors in the emergency department: study protocol of the CHARMED cluster randomized study. BMC Emerg Med. 2015 Sep 4;15:21. doi: 10.1186/s12873-015-0046-1.

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


title: Cancer and Deafness Associated With the Use of Platinum Derivatives in Children

acronym: OTOPLAT

summary: A limited number of relatively contradictory studies have suggested that the development of serious ototoxicity in children treated with cisplatin or, more rarely, carboplatin could be partly related to genetic risk factors affecting detoxification enzymes and membrane transporters of platinum derivatives. The objective of this study is therefore to identify genetic variants associated with the development of platinum ototoxicity in patients treated with cisplatin or carboplatin (minimum follow-up of 3 years) for one of the following diseases: neuroblastoma, hepatoblastoma, retinoblastoma, malignant germ cell tumour, osteosarcoma, high-risk or recurrent Wilms' tumour, non-parameningealrhabdomyosarcoma. A total of 180 patients, corresponding to 60 cases with grade 3 or 4 ototoxicity and 120 controls with no signs of ototoxicity (separate complete audiograms for each ear) will be included. A saliva sample will be used to obtain DNA for pharmacogenetic studies. The value of this study will be to define a population at high risk of developing ototoxicity in order to adapt treatment, or even develop preventive treatment of ototoxicity based on antioxidant medications

time_perspective: Retrospective

intervention_type: Genetic


title: Study of the Cutaneous Reinnervation After Burn With the Aim of a Better Care of Neuropathic Pain and Pruritus After Healing

acronym: NERVAL

summary:
The aim of this study is to understand why the regeneration of the cutaneous sensory nerve fibers is poor in post-burn scar.

The presence or the lack of several molecular factors known to regulate neuronal cell development will be evaluate and compared within biopsies from healthy skin and post-burn scar.

lead_sponsor: University Hospital, Brest


title: Effects of Geriatric Inclusive Art Activity in Nursing Home Residents (GIA)

summary: The study aimed to compare the changes in health and functional status between nursing home residents practicing GIA activity and a control group of residents, and to examine the changes in residents' abilities to participate in GIA activity.


title: Comparison of Two Surgical Strategies of Total Knee Arthroplasty : Cemented Versus Uncemented HLS Knee-Tec Prosthesis System. A Prospective Randomized Study.

acronym: HLS

summary:
The goal of this prospective randomized double-blind study is to compare clinical and radiological results of cemented and uncemented total knee arthroplasty (TKA).

Two hundred and fifty patients will be randomized in two groups : cemented TKA and uncemented TKA.

The primary outcome is the comparison of the International Knee Society (IKS) Score revised in 2011 at one year postoperative.

The second outcome is the comparison of standard one year-postoperative x-rays looking for signs of loosening.

status: Withdrawn

lead_sponsor: Hospices Civils de Lyon


title: Accuracy of Unenhanced CT in Elderly Patients Admitted to the Emergency Department With Acute Abdominal Symptoms

summary: The purpose of this study is to determine whether non-contrast abdominal computed tomography (CT) impacts management (diagnosis, need for surgery and treatment) in elderly patients admitted to the emergency department with abdominal pain.

lead_sponsor: University Hospital, Montpellier


summary: The objective of this randomized trial is to study the effect of stress on performance and the effect of repetition of simulation sessions on performance and stress. This study is a randomized controlled trial including 48 participants who composed 12 multidisciplinary teams (MDTs). Each MDT was made up of 4 persons: an emergency physician, a resident, a nurse, and an ambulance driver who usually compose an emergency team of the French Emergency Medical Service (EMS). 6 MDTs underwent 9 simulation sessions over 1 year (Repetitive SIm Group). 6 MDTs underwent 3 simulation sessions over 1 year (Control Group). Evidence of the existence of stress was assessed in 3 ways: salivary cortisol, Holter parameters, and psychological stress questionnaires. The impact of stress on overall team performance, on technical procedure, and on teamwork, is evaluated by specific validated scales. Detection of post-traumatic stress (PTSD) is performed by self-evaluation on the 7th day and after one month. The perspective is to concomitantly evaluate technical and non-technical performance, and the impact of stress on both. This is the first randomized trial studying repetition of simulation sessions and its impact on both clinical performance and stress as explored by objective and subjective assessments. The investigators expect that stress decreases team performance and that repeated simulation increases team performance. The investigators expect no variation of stress parameters regardless of level of performance.

ReferenceCitation: Ghazali DA, Breque C, Sosner P, Lesbordes M, Chavagnat JJ, Ragot S, Oriot D. Stress response in the daily lives of simulation repeaters. A randomized controlled trial assessing stress evolution over one year of repetitive immersive simulations. PLoS One. 2019 Jul 25;14(7):e0220111. doi: 10.1371/journal.pone.0220111. eCollection 2019.

family: Ghazali

full_name: Daniel Aiham Ghazali

given: Daniel Aiham

family: Breque

full_name: Cyril Breque

given: Cyril

family: Sosner

full_name: Philippe Sosner

given: Philippe

family: Lesbordes

full_name: Mathieu Lesbordes

given: Mathieu

family: Chavagnat

full_name: Jean-Jacques Chavagnat

given: Jean-Jacques

family: Ragot

full_name: Stéphanie Ragot

given: Stéphanie

family: Oriot

full_name: Denis Oriot

given: Denis

currency_apc_doaj: USD

journal_name: PLOS ONE

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

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

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

ReferenceCitation: Ghazali DA, Darmian-Rafei I, Ragot S, Oriot D. Performance Under Stress Conditions During Multidisciplinary Team Immersive Pediatric Simulations. Pediatr Crit Care Med. 2018 Jun;19(6):e270-e278. doi: 10.1097/PCC.0000000000001473.

family: Darmian-Rafei

full_name: Ivan Darmian-Rafei

given: Ivan

journal_name: Pediatric Critical Care Medicine

title: Performance Under Stress Conditions During Multidisciplinary Team Immersive Pediatric Simulations*

ReferenceCitation: Ghazali DA, Ragot S, Breque C, Guechi Y, Boureau-Voultoury A, Petitpas F, Oriot D. Randomized controlled trial of multidisciplinary team stress and performance in immersive simulation for management of infant in shock: study protocol. Scand J Trauma Resusc Emerg Med. 2016 Mar 25;24:36. doi: 10.1186/s13049-016-0229-0.

journal_name: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine


title: Benefits of Sleep Extension on Cognitive and Physical Performances During Baseline, Total Sleep Deprivation and Recovery (BankingSleep)

acronym: BankingSleep

summary:
Objectives: investigate the effects of 6 nights of sleep extension on physical and cognitive performances before, during total sleep deprivation (39 hours continuous awaking) and after a subsequent recovery sleep.

Design: Subjects participated in two experimental conditions (randomized cross-over design): extended sleep (10-h in bed, EXT) and habitual sleep (8-h in bed, HAB). In each condition, subjects performed two consecutive phases: (1) six nights of either EXT or HAB (2) three experiments days in-laboratory:baseline (BASE), sleep deprivation (TSD) and after 10 h of recovery sleep(REC). Performance tests were administered every 3 hours over the 3-d in laboratory.

Setting: This cross-over and randomized study was conducted under standardized laboratory conditions with continuous polysomnographic recording Participants: 14 healthy men (age range: 26-37 years) participated in the study.

Interventions: EXT vs. HAB sleep durations prior to total sleep deprivation (39 hr continuous awaking).

ReferenceCitation: Rupp TL, Wesensten NJ, Bliese PD, Balkin TJ. Banking sleep: realization of benefits during subsequent sleep restriction and recovery. Sleep. 2009 Mar;32(3):311-21.

ReferenceCitation: Chennaoui M, Sauvet F, Drogou C, Van Beers P, Langrume C, Guillard M, Gourby B, Bourrilhon C, Florence G, Gomez-Merino D. Effect of one night of sleep loss on changes in tumor necrosis factor alpha (TNF-α) levels in healthy men. Cytokine. 2011 Nov;56(2):318-24. doi: 10.1016/j.cyto.2011.06.002. Epub 2011 Jul 6.

ReferenceCitation: Sauvet F, Leftheriotis G, Gomez-Merino D, Langrume C, Drogou C, Van Beers P, Bourrilhon C, Florence G, Chennaoui M. Effect of acute sleep deprivation on vascular function in healthy subjects. J Appl Physiol (1985). 2010 Jan;108(1):68-75. doi: 10.1152/japplphysiol.00851.2009. Epub 2009 Nov 12.

ReferenceCitation: Chennaoui M, Arnal PJ, Sauvet F, Léger D. Sleep and exercise: a reciprocal issue? Sleep Med Rev. 2015 Apr;20:59-72. doi: 10.1016/j.smrv.2014.06.008. Epub 2014 Jun 30. Review.

ReferenceCitation: Temesi J, Arnal PJ, Davranche K, Bonnefoy R, Levy P, Verges S, Millet GY. Does central fatigue explain reduced cycling after complete sleep deprivation? Med Sci Sports Exerc. 2013 Dec;45(12):2243-53. doi: 10.1249/MSS.0b013e31829ce379.

ReferenceCitation: Rabat A, Arnal PJ, Monnard H, Erblang M, Van Beers P, Bougard C, Drogou C, Guillard M, Sauvet F, Leger D, Gomez-Merino D, Chennaoui M. Limited Benefit of Sleep Extension on Cognitive Deficits During Total Sleep Deprivation: Illustration With Two Executive Processes. Front Neurosci. 2019 Jun 19;13:591. doi: 10.3389/fnins.2019.00591. eCollection 2019.

family: Rabat

full_name: Arnaud Rabat

given: Arnaud

family: Arnal

full_name: Pierrick J. Arnal

given: Pierrick J.

family: Monnard

full_name: Hortense Monnard

given: Hortense

family: Erblang

full_name: Mégane Erblang

given: Mégane

family: Van Beers

full_name: Pascal Van Beers

given: Pascal

family: Bougard

full_name: Clément Bougard

given: Clément

family: Drogou

full_name: Catherine Drogou

given: Catherine

family: Guillard

full_name: Mathias Guillard

given: Mathias

family: Sauvet

full_name: Fabien Sauvet

given: Fabien

family: Leger

full_name: Damien Leger

given: Damien

family: Gomez-Merino

full_name: Danielle Gomez-Merino

given: Danielle

family: Chennaoui

full_name: Mounir Chennaoui

given: Mounir

bso_classification: Biology (fond.)

journal_name: Frontiers in Neuroscience

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

lead_sponsor: Institut de Recherche Biomedicale des Armees


title: Effect of High-Intensity Intermittent Exercise on Abdominal Fat Mass in Type 2 Diabetes Postmenopausal Women.

summary:
Postmenopausal women, as men, are more prone to central or android obesity. Abdominal fat mass is associated with an increase of cardiovascular diseases (CVD). In type 2 diabetic (T2D) patients, the risk of CVD mortality is more than double compared with that in age-matched subjects.

Most exercise programs designed for weight loss have focused on steady-state exercise (SEE) of around 30 min at a moderate intensity several times a week. Disappointingly, these kinds of exercise programs have led to little or no fat loss (Shaw et al. 2006). Accumulating evidence suggests that high intensity intermittent exercise (HIIE) has the potential to be an effective exercise protocol for reducing fat of overweight individuals, especially at the abdominal level (Boutcher 2011, Kessler 2012). Despite these results, HIIE program has never been used in TD2 postmenopausal women to favor a specific decrease of abdominal fat mass.

The aim of our study was to compare the effects of 16-week steady-state exercise (SSE) program with high intensity intermittent exercise (HIIE) program on total abdominal and visceral fat mass in T2D postmenopausal women.

It is hypothesized that HIIE compared to SSE program would result in significantly greater reductions in total abdominal and visceral fat mass.


title: Prognostic Value of Myocardial Fibrosis Quantified Using CMR in Patient With Dilated Cardiomyopathy

summary:
: Fibrosis, in general, is a scarring process, which is characterized by fibroblast accumulation and excess deposition of extracellular matrix (ECM) proteins, which leads to distorted organ architecture and function. The contribution of fibrogenesis to impaired cardiac function is increasingly recognized. The fibrotic ECM causes increased stiffness and induces pathological signaling within cardiomyocytes resulting in progressive cardiac failure. Also, the excessive ECM impairs mechano-electric coupling of cardiomyocytes and increases the risk of arrhythmias. But today patient treatment and prognosis is based on ejection fraction quantification, QRS duration, and symptoms.

Hypothesis: the increased level of fibrosis quantified using T1 mapping technique, compared with normal value, is of prognostic value in patient with dilated cardiomyopathies under optimal treatment.

Methods: 330 patients are planned to be included and followed for 2 years

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille