title: Risk-stratified Randomized Controlled Trial in Paediatric Crohn Disease:Methotrexate vs Azathioprine or Adalimumab for Maintaining Remission in Patients at Low or High Risk for Aggressive Disease Course, respectively-a Treatment Strategy

acronym: RCT

summary:
The purpose of this study is to compare the effectiveness of weekly subcutaneously administered Methotrexate for maintaining relapse-free sustained steroid/Enteral Nutrition -free 1-year remission compared with:

daily oral Azathioprine / 6 mercaptopurine in low risk paediatric Crohn's disease
subcutaneously administered adalimumab in high risk paediatric Crohn's disease

ReferenceCitation: Pearson DC, May GR, Fick G, Sutherland LR. Azathioprine for maintaining remission of Crohn's disease. Cochrane Database Syst Rev. 2000;(2):CD000067. Review. Update in: Cochrane Database Syst Rev. 2009;(1):CD000067.

ReferenceCitation: Faubion WA Jr, Bousvaros A. Medical therapy for refractory pediatric Crohn's disease. Clin Gastroenterol Hepatol. 2006 Oct;4(10):1199-213. Epub 2006 Jul 26. Review.

ReferenceCitation: Candy S, Wright J, Gerber M, Adams G, Gerig M, Goodman R. A controlled double blind study of azathioprine in the management of Crohn's disease. Gut. 1995 Nov;37(5):674-8.

ReferenceCitation: Markowitz J, Grancher K, Kohn N, Lesser M, Daum F. A multicenter trial of 6-mercaptopurine and prednisone in children with newly diagnosed Crohn's disease. Gastroenterology. 2000 Oct;119(4):895-902.

ReferenceCitation: D'Haens G, Geboes K, Rutgeerts P. Endoscopic and histologic healing of Crohn's (ileo-) colitis with azathioprine. Gastrointest Endosc. 1999 Nov;50(5):667-71.

ReferenceCitation: Chatu S, Subramanian V, Saxena S, Pollok RC. The role of thiopurines in reducing the need for surgical resection in Crohn's disease: a systematic review and meta-analysis. Am J Gastroenterol. 2014 Jan;109(1):23-34; quiz 35. doi: 10.1038/ajg.2013.402. Epub 2013 Dec 10.

ReferenceCitation: Panés J, López-Sanromán A, Bermejo F, García-Sánchez V, Esteve M, Torres Y, Domènech E, Piqueras M, Gomez-García M, Gutiérrez A, Taxonera C, Sans M; AZTEC Study Group. Early azathioprine therapy is no more effective than placebo for newly diagnosed Crohn's disease. Gastroenterology. 2013 Oct;145(4):766-74.e1. doi: 10.1053/j.gastro.2013.06.009. Epub 2013 Jun 13.

ReferenceCitation: Cosnes J, Bourrier A, Laharie D, Nahon S, Bouhnik Y, Carbonnel F, Allez M, Dupas JL, Reimund JM, Savoye G, Jouet P, Moreau J, Mary JY, Colombel JF; Groupe d'Etude Thérapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Early administration of azathioprine vs conventional management of Crohn's Disease: a randomized controlled trial. Gastroenterology. 2013 Oct;145(4):758-65.e2; quiz e14-5. doi: 10.1053/j.gastro.2013.04.048. Epub 2013 Apr 30.

family: Cosnes

full_name: Jacques Cosnes

given: Jacques

family: Bourrier

full_name: Anne Bourrier

given: Anne

family: Laharie

full_name: David Laharie

given: David

family: Nahon

full_name: Stéphane Nahon

given: Stéphane

family: Bouhnik

full_name: Yoram Bouhnik

given: Yoram

family: Carbonnel

full_name: Franck Carbonnel

given: Franck

family: Allez

full_name: Matthieu Allez

given: Matthieu

family: Dupas

full_name: Jean–Louis Dupas

given: Jean–Louis

family: Reimund

full_name: Jean–Marie Reimund

given: Jean–Marie

family: Savoye

full_name: Guillaume Savoye

given: Guillaume

family: Jouet

full_name: Pauline Jouet

given: Pauline

family: Moreau

full_name: Jacques Moreau

family: Mary

full_name: Jean–Yves Mary

given: Jean–Yves

family: Colombel

full_name: Jean–Frédéric Colombel

given: Jean–Frédéric

journal_name: Gastroenterology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Early Administration of Azathioprine vs Conventional Management of Crohn's Disease: A Randomized Controlled Trial

ReferenceCitation: Alfadhli AA, McDonald JW, Feagan BG. Methotrexate for induction of remission in refractory Crohn's disease. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD003459. Review. Update in: Cochrane Database Syst Rev. 2012;12:CD003459.

ReferenceCitation: Feagan BG, Fedorak RN, Irvine EJ, Wild G, Sutherland L, Steinhart AH, Greenberg GR, Koval J, Wong CJ, Hopkins M, Hanauer SB, McDonald JW. A comparison of methotrexate with placebo for the maintenance of remission in Crohn's disease. North American Crohn's Study Group Investigators. N Engl J Med. 2000 Jun 1;342(22):1627-32.

ReferenceCitation: Feagan BG, Rochon J, Fedorak RN, Irvine EJ, Wild G, Sutherland L, Steinhart AH, Greenberg GR, Gillies R, Hopkins M, et al. Methotrexate for the treatment of Crohn's disease. The North American Crohn's Study Group Investigators. N Engl J Med. 1995 Feb 2;332(5):292-7.

ReferenceCitation: Kozarek RA, Patterson DJ, Gelfand MD, Botoman VA, Ball TJ, Wilske KR. Methotrexate induces clinical and histologic remission in patients with refractory inflammatory bowel disease. Ann Intern Med. 1989 Mar 1;110(5):353-6.

ReferenceCitation: Holtmann MH, Krummenauer F, Claas C, Kremeyer K, Lorenz D, Rainer O, Vogel I, Böcker U, Böhm S, Büning C, Duchmann R, Gerken G, Herfarth H, Lügering N, Kruis W, Reinshagen M, Schmidt J, Stallmach A, Stein J, Sturm A, Galle PR, Hommes DW, D'Haens G, Rutgeerts P, Neurath MF. Long-term effectiveness of azathioprine in IBD beyond 4 years: a European multicenter study in 1176 patients. Dig Dis Sci. 2006 Sep;51(9):1516-24. Epub 2006 Aug 22.

ReferenceCitation: Lémann M, Mary JY, Colombel JF, Duclos B, Soule JC, Lerebours E, Modigliani R, Bouhnik Y; Groupe D'Etude Thérapeutique des Affections Inflammatoires du Tube Digestif. A randomized, double-blind, controlled withdrawal trial in Crohn's disease patients in long-term remission on azathioprine. Gastroenterology. 2005 Jun;128(7):1812-8.

ReferenceCitation: Lémann M, Zenjari T, Bouhnik Y, Cosnes J, Mesnard B, Rambaud JC, Modigliani R, Cortot A, Colombel JF. Methotrexate in Crohn's disease: long-term efficacy and toxicity. Am J Gastroenterol. 2000 Jul;95(7):1730-4.

ReferenceCitation: Ardizzone S, Bollani S, Manzionna G, Imbesi V, Colombo E, Bianchi Porro G. Comparison between methotrexate and azathioprine in the treatment of chronic active Crohn's disease: a randomised, investigator-blind study. Dig Liver Dis. 2003 Sep;35(9):619-27.

ReferenceCitation: Oren R, Moshkowitz M, Odes S, Becker S, Keter D, Pomeranz I, Shirin H, Reisfeld I, Broide E, Lavy A, Fich A, Eliakim R, Patz J, Villa Y, Arber N, Gilat T. Methotrexate in chronic active Crohn's disease: a double-blind, randomized, Israeli multicenter trial. Am J Gastroenterol. 1997 Dec;92(12):2203-9. Erratum in: Am J Gastroenterol. 2015 Apr;110(4):608. Shirin, C [corrected to Shirin, H].

ReferenceCitation: Ravikumara M, Hinsberger A, Spray CH. Role of methotrexate in the management of Crohn disease. J Pediatr Gastroenterol Nutr. 2007 Apr;44(4):427-30.

ReferenceCitation: Mack DR, Young R, Kaufman SS, Ramey L, Vanderhoof JA. Methotrexate in patients with Crohn's disease after 6-mercaptopurine. J Pediatr. 1998 May;132(5):830-5.

ReferenceCitation: Uhlen S, Belbouab R, Narebski K, Goulet O, Schmitz J, Cézard JP, Turck D, Ruemmele FM. Efficacy of methotrexate in pediatric Crohn's disease: a French multicenter study. Inflamm Bowel Dis. 2006 Nov;12(11):1053-7.

ReferenceCitation: Turner D, Grossman AB, Rosh J, Kugathasan S, Gilman AR, Baldassano R, Griffiths AM. Methotrexate following unsuccessful thiopurine therapy in pediatric Crohn's disease. Am J Gastroenterol. 2007 Dec;102(12):2804-12; quiz 2803, 2813.

ReferenceCitation: Hyams J, Crandall W, Kugathasan S, Griffiths A, Olson A, Johanns J, Liu G, Travers S, Heuschkel R, Markowitz J, Cohen S, Winter H, Veereman-Wauters G, Ferry G, Baldassano R; REACH Study Group. Induction and maintenance infliximab therapy for the treatment of moderate-to-severe Crohn's disease in children. Gastroenterology. 2007 Mar;132(3):863-73; quiz 1165-6. Epub 2006 Dec 3.

ReferenceCitation: Hyams JS, Griffiths A, Markowitz J, Baldassano RN, Faubion WA Jr, Colletti RB, Dubinsky M, Kierkus J, Rosh J, Wang Y, Huang B, Bittle B, Marshall M, Lazar A. Safety and efficacy of adalimumab for moderate to severe Crohn's disease in children. Gastroenterology. 2012 Aug;143(2):365-74.e2. doi: 10.1053/j.gastro.2012.04.046. Epub 2012 May 2.

family: Hyams

full_name: Jeffrey S. Hyams

given: Jeffrey S.

title: Safety and Efficacy of Adalimumab for Moderate to Severe Crohn's Disease in Children

ReferenceCitation: D'Haens G, Baert F, van Assche G, Caenepeel P, Vergauwe P, Tuynman H, De Vos M, van Deventer S, Stitt L, Donner A, Vermeire S, Van De Mierop FJ, Coche JR, van der Woude J, Ochsenkühn T, van Bodegraven AA, Van Hootegem PP, Lambrecht GL, Mana F, Rutgeerts P, Feagan BG, Hommes D; Belgian Inflammatory Bowel Disease Research Group; North-Holland Gut Club. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn's disease: an open randomised trial. Lancet. 2008 Feb 23;371(9613):660-667. doi: 10.1016/S0140-6736(08)60304-9.

ReferenceCitation: Prideaux L, De Cruz P, Ng SC, Kamm MA. Serological antibodies in inflammatory bowel disease: a systematic review. Inflamm Bowel Dis. 2012 Jul;18(7):1340-55. doi: 10.1002/ibd.21903. Epub 2011 Nov 8. Review.

ReferenceCitation: North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition; Colitis Foundation of America, Bousvaros A, Antonioli DA, Colletti RB, Dubinsky MC, Glickman JN, Gold BD, Griffiths AM, Jevon GP, Higuchi LM, Hyams JS, Kirschner BS, Kugathasan S, Baldassano RN, Russo PA. Differentiating ulcerative colitis from Crohn disease in children and young adults: report of a working group of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the Crohn's and Colitis Foundation of America. J Pediatr Gastroenterol Nutr. 2007 May;44(5):653-74.

ReferenceCitation: Winther KV, Føgh P, Thomsen OØ, Brynskov J. Inflammatory bowel disease (ulcerative colitis and Crohn's disease): diagnostic criteria and differential diagnosis. Drugs Today (Barc). 1998 Nov;34(11):935-42.

ReferenceCitation: Rosh JR. Methotrexate. In: Mamula P, Baldassano RN, Markowitz JE, editors. Pediatric inflammatory bowel disease2007. p. In press.

ReferenceCitation: Ruemmele FM, Veres G, Kolho KL, Griffiths A, Levine A, Escher JC, Amil Dias J, Barabino A, Braegger CP, Bronsky J, Buderus S, Martín-de-Carpi J, De Ridder L, Fagerberg UL, Hugot JP, Kierkus J, Kolacek S, Koletzko S, Lionetti P, Miele E, Navas López VM, Paerregaard A, Russell RK, Serban DE, Shaoul R, Van Rheenen P, Veereman G, Weiss B, Wilson D, Dignass A, Eliakim A, Winter H, Turner D; European Crohn's and Colitis Organisation; European Society of Pediatric Gastroenterology, Hepatology and Nutrition. Consensus guidelines of ECCO/ESPGHAN on the medical management of pediatric Crohn's disease. J Crohns Colitis. 2014 Oct;8(10):1179-207. doi: 10.1016/j.crohns.2014.04.005. Epub 2014 Jun 6.

ReferenceCitation: Frøslie KF, Jahnsen J, Moum BA, Vatn MH; IBSEN Group. Mucosal healing in inflammatory bowel disease: results from a Norwegian population-based cohort. Gastroenterology. 2007 Aug;133(2):412-22. Epub 2007 Jun 2.

ReferenceCitation: Vernier-Massouille G, Balde M, Salleron J, Turck D, Dupas JL, Mouterde O, Merle V, Salomez JL, Branche J, Marti R, Lerebours E, Cortot A, Gower-Rousseau C, Colombel JF. Natural history of pediatric Crohn's disease: a population-based cohort study. Gastroenterology. 2008 Oct;135(4):1106-13. doi: 10.1053/j.gastro.2008.06.079. Epub 2008 Jul 3.

ReferenceCitation: Van Limbergen J, Russell RK, Drummond HE, Aldhous MC, Round NK, Nimmo ER, Smith L, Gillett PM, McGrogan P, Weaver LT, Bisset WM, Mahdi G, Arnott ID, Satsangi J, Wilson DC. Definition of phenotypic characteristics of childhood-onset inflammatory bowel disease. Gastroenterology. 2008 Oct;135(4):1114-22. doi: 10.1053/j.gastro.2008.06.081. Epub 2008 Jul 3.

ReferenceCitation: Pigneur B, Escher J, Elawad M, Lima R, Buderus S, Kierkus J, Guariso G, Canioni D, Lambot K, Talbotec C, Shah N, Begue B, Rieux-Laucat F, Goulet O, Cerf-Bensussan N, Neven B, Ruemmele FM. Phenotypic characterization of very early-onset IBD due to mutations in the IL10, IL10 receptor alpha or beta gene: a survey of the Genius Working Group. Inflamm Bowel Dis. 2013 Dec;19(13):2820-8. doi: 10.1097/01.MIB.0000435439.22484.d3.

ReferenceCitation: Pigneur B, Seksik P, Viola S, Viala J, Beaugerie L, Girardet JP, Ruemmele FM, Cosnes J. Natural history of Crohn's disease: comparison between childhood- and adult-onset disease. Inflamm Bowel Dis. 2010 Jun;16(6):953-61. doi: 10.1002/ibd.21152.

ReferenceCitation: Ruemmele FM, Lachaux A, Cézard JP, Morali A, Maurage C, Giniès JL, Viola S, Goulet O, Lamireau T, Scaillon M, Breton A, Sarles J; Groupe Francophone d'Hépatologie, Gastroentérologie et Nutrition Pédiatrique. Efficacy of infliximab in pediatric Crohn's disease: a randomized multicenter open-label trial comparing scheduled to on demand maintenance therapy. Inflamm Bowel Dis. 2009 Mar;15(3):388-94. doi: 10.1002/ibd.20788.

ReferenceCitation: Sharma S, Eckert D, Hyams JS, Mensing S, Thakkar RB, Robinson AM, Rosh JR, Ruemmele FM, Awni WM. Pharmacokinetics and exposure-efficacy relationship of adalimumab in pediatric patients with moderate to severe Crohn's disease: results from a randomized, multicenter, phase-3 study. Inflamm Bowel Dis. 2015 Apr;21(4):783-92. doi: 10.1097/MIB.0000000000000327.

ReferenceCitation: Khanna R, Bressler B, Levesque BG, Zou G, Stitt LW, Greenberg GR, Panaccione R, Bitton A, Paré P, Vermeire S, D'Haens G, MacIntosh D, Sandborn WJ, Donner A, Vandervoort MK, Morris JC, Feagan BG; REACT Study Investigators. Early combined immunosuppression for the management of Crohn's disease (REACT): a cluster randomised controlled trial. Lancet. 2015 Nov 7;386(10006):1825-34. doi: 10.1016/S0140-6736(15)00068-9. Epub 2015 Sep 3.

ReferenceCitation: Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.

title: Infliximab, Azathioprine, or Combination Therapy for Crohn's Disease

ReferenceCitation: Torres J, Caprioli F, Katsanos KH, Lobatón T, Micic D, Zerôncio M, Van Assche G, Lee JC, Lindsay JO, Rubin DT, Panaccione R, Colombel JF. Predicting Outcomes to Optimize Disease Management in Inflammatory Bowel Diseases. J Crohns Colitis. 2016 Dec;10(12):1385-1394. Epub 2016 Jun 9. Erratum in: J Crohns Colitis. 2016 Dec;10 (12 ):1457.

ReferenceCitation: Neyt M, Christiaens A, Aloi M, de Ridder L, Croft NM, Koletzko S, Levine A, Turner D, Russell RK, Ruemmele FM, Veereman G. Identifying Health Economic Considerations to Include in the Research Protocol of a Randomized Controlled Trial (the REDUCE-RISK Trial): Systematic Literature Review and Assessment. JMIR Form Res. 2021 Jan 25;5(1):e13888. doi: 10.2196/13888. Review.

repository_institution: Queen Mary University of London - Queen Mary Research Online

ReferenceCitation: Harris RE, Aloi M, de Ridder L, Croft NM, Koletzko S, Levine A, Turner D, Veereman G, Neyt M, Bigot L, Ruemmele FM, Russell RK; PIBD SETQuality consortium and PIBDnet. Protocol for a multinational risk-stratified randomised controlled trial in paediatric Crohn's disease: methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or high risk for aggressive disease course. BMJ Open. 2020 Jul 1;10(7):e034892. doi: 10.1136/bmjopen-2019-034892.

repository_institution: The University of Glasgow - Enlighten: Publications

title: Protocol for a multinational risk-stratified randomised controlled trial in paediatric Crohn’s disease: methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or high risk for aggressive disease course

location_facility: Hôpital Necker -Enfants Malades (Service de gastro-enterologie)


title: Assessment of a Tool for Decision Making in Case of Worsening Condition of Cancer Patients

acronym: CBP-Aggrav

summary: Observational two year study to evaluate the utility of a decision-support sheet on how to proceed in case of aggravation of a patient's condition with advanced disease.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Toffart AC, Sakhri L, Girard N, Couraud S, Merle P, Fournel P, Perol M, Souquet PJ, Timsit JF, Moro-Sibilot D. [Assessment of a tool for decision making in case of worsening condition of cancer patients]. Rev Mal Respir. 2015 Jan;32(1):66-72. doi: 10.1016/j.rmr.2014.02.006. Epub 2014 Mar 20. French.

ReferenceCitation: Toffart AC, Pizarro CA, Schwebel C, Sakhri L, Minet C, Duruisseaux M, Azoulay E, Moro-Sibilot D, Timsit JF. Selection criteria for intensive care unit referral of lung cancer patients: a pilot study. Eur Respir J. 2015 Feb;45(2):491-500. doi: 10.1183/09031936.00118114. Epub 2014 Oct 16.

family: Toffart

full_name: Anne-Claire Toffart

given: Anne-Claire

sequence: first

family: Pizarro

full_name: Carola Alegria Pizarro

given: Carola Alegria

sequence: additional

family: Schwebel

full_name: Carole Schwebel

given: Carole

family: Sakhri

full_name: Linda Sakhri

given: Linda

family: Minet

full_name: Clemence Minet

given: Clemence

family: Duruisseaux

full_name: Michaël Duruisseaux

given: Michaël

family: Azoulay

full_name: Elie Azoulay

given: Elie

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Respiratory Journal

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

ReferenceCitation: Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010 Mar 23;340:c1345. doi: 10.1136/bmj.c1345.

ReferenceCitation: Garrouste-Orgeas M, Tabah A, Vesin A, Philippart F, Kpodji A, Bruel C, Grégoire C, Max A, Timsit JF, Misset B. The ETHICA study (part II): simulation study of determinants and variability of ICU physician decisions in patients aged 80 or over. Intensive Care Med. 2013 Sep;39(9):1574-83. doi: 10.1007/s00134-013-2977-x. Epub 2013 Jun 14.

ReferenceType: derived

ReferenceCitation: Denis N, Timsit JF, Giaj Levra M, Sakhri L, Duruisseaux M, Schwebel C, Merle P, Pinsolle J, Ferrer L, Moro-Sibilot D, Toffart AC. Impact of systematic advanced care planning in lung cancer patients: A prospective study. Respir Med Res. 2020 Mar;77:11-17. doi: 10.1016/j.resmer.2019.09.003. Epub 2019 Oct 28.

family: Denis

full_name: N. Denis

given: N.

full_name: J.-F. Timsit

family: Giaj Levra

full_name: M. Giaj Levra

given: M.

full_name: L. Sakhri

given: L.

full_name: M. Duruisseaux

full_name: C. Schwebel

given: C.

family: Merle

full_name: P. Merle

given: P.

family: Pinsolle

full_name: J. Pinsolle

given: J.

family: Ferrer

full_name: L. Ferrer

full_name: D. Moro-Sibilot

given: D.


title: Etude de Concordance Entre la Technique OSNA et Les Techniques Classiques Pour la Recherche de métastases Ganglionnaires Des Cancers Des VADS

acronym: OSNA-ORL

summary: The investigators main objective is to show that OSNA technique is as accurate as pathological analysis (frozen section / HE staining and immunochemistry) to detect occult lymph node metastasis (micro and macrometastasis).

ReferenceCitation: Peigné L, Godey F, Le Gallo M, Le Gall F, Fautrel A, Morcet J, Jégoux F. One-step nucleic acid amplification for detecting lymph node metastasis of head and neck squamous cell carcinoma. Oral Oncol. 2020 Mar;102:104553. doi: 10.1016/j.oraloncology.2019.104553. Epub 2020 Jan 28.

family: Peigné

full_name: Lucie Peigné

given: Lucie

family: Godey

full_name: Florence Godey

given: Florence

family: Le Gallo

full_name: Mathieu Le Gallo

given: Mathieu

family: Le Gall

full_name: François Le Gall

given: François

family: Fautrel

full_name: Alain Fautrel

given: Alain

family: Morcet

full_name: Jeff Morcet

given: Jeff

family: Jégoux

full_name: Franck Jégoux

given: Franck

journal_name: Oral Oncology

lead_sponsor: Rennes University Hospital

location_facility: Centre hospitalier universitaire de Rennes

lead_sponsor_type: academique

status_simplified: Completed


title: Urinary Markers of Detrusor Overactivity in Spina Bifida Patients

acronym: BUHD-SPINA

summary: The purpose of this study is to assess diagnostic performance of urinary markers of detrusor overactivity (Nerve Growth Factor (NGF), Brain-Derived Neurotrophic Factor (BDNF), adenosine triphosphate (ATP), Prostaglandine E2) in detected high pressure bladder un spina bifida patients.


title: Assessment of the Prevalence of Lysosomal Acid Lipase Deficiency in Patients Waiting for a Liver Transplant.

summary:
Lysosomal Acid Lipase (LAL) deficiency is a rare, autosomal recessive storage disease linked to decrease enzymatic activity of LAL, responsible for intracellular accumulation of cholesterol esters and triglycerides.

The accumulation of lipid is in hepatocytes, Kupffer cells and macrophages leading to a fatty liver, hepatic fibrosis that can evolve up to cirrhosis.

LAL deficiency is responsible for significant morbidity and early mortality in children, adolescents and adults in connection with a multi visceral disease reaching the liver, gastrointestinal tract and the vascular endothelium. The disease is caused by homozygous or heterozygous mutations in the gene (LIPA chromosome 10q23.2-23.3) which is responsible for the synthesis of the LAL.

The disease can be diagnosed by enzymatic analysis using few drops of blood absorbed onto blotting paper .

Patients with this deficiency LAL, have no or reduced activity of this enzyme. Because of its rarity, the deficit in LAL is under diagnosed or is diagnosed in patients with liver biological disturbances and / or lipid profile disturbances, steatohepatitis-hepatitis (NASH), the steatosis (NAFLD), the cryptogenic cirrhosis or Wilson disease.

Inclusion period of 12 to 18 months (100 patients).

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

location_facility: Hépato-Gastro-Entérologie, Hôpital de la Croix Rousse, 103 gde rue de la Croix Rousse

status_simplified: Unknown


title: Screening for Frailty in Elderly Subjects Living at Home : Validation of the Modified Short Emergency Geriatric Assessment (SEGAm) Instrument

acronym: SEGAm

summary:
"Many tools to evaluate frailty have been developed. However, at the time our study was designed, none of these instruments had been validated in terms of psychometric properties. The aim of this study was to validate the modified version of the Short Emergency Geriatric Assessment (SEGAm) frailty instrument in elderly people living at home.

It was an observational, longitudinal, prospective, multicentre study, set up in four departments (Ardennes, Marne, Meurthe-et-Moselle, Meuse) in two French regions (Champagne-Ardenne and Lorraine). Subjects was aged 65 years or more, living at home, and was able to read and understand French, with a degree of autonomy corresponding to groups 5, or 6 in the AGGIR autonomy evaluation scale. Assessment included demographic characteristics, comprehensive geriatric assessment, and the SEGAm instrument. Psychometric validation was used to study feasibility and acceptability, internal structure validity, reliability, and discriminant validity of the SEGAm instrument. "

status: Terminated

time_perspective: Other

ReferenceCitation: Oubaya N, Mahmoudi R, Jolly D, Zulfiqar AA, Quignard E, Cunin C, Nazeyrollas P, Novella JL, Dramé M. Screening for frailty in elderly subjects living at home: validation of the Modified Short Emergency Geriatric Assessment (SEGAm) instrument. J Nutr Health Aging. 2014;18(8):757-64. doi: 10.1007/s12603-014-0466-8.

lead_sponsor: CHU de Reims

intervention_type: Other


title: Validation of an Attachment Picture Set in School-adolescent

summary: this study aims to validate a picture data set that particularly activates the attachment process and that could be used in attachment studies.

study_type: Interventional

ReferenceType: result

ReferenceCitation: Szymanska M, Monnin J, Noiret N, Tio G, Galdon L, Laurent E, Nezelof S, Vulliez-Coady L. The Besançon Affective Picture Set-Adolescents (the BAPS-Ado): Development and validation. Psychiatry Res. 2015 Aug 30;228(3):576-84. doi: 10.1016/j.psychres.2015.04.055. Epub 2015 Jun 20.

family: Szymanska

full_name: Monika Szymanska

given: Monika

family: Monnin

full_name: Julie Monnin

given: Julie

family: Noiret

full_name: Nicolas Noiret

given: Nicolas

family: Tio

full_name: Grégory Tio

given: Grégory

family: Galdon

full_name: Lucie Galdon

family: Laurent

full_name: Eric Laurent

given: Eric

family: Nezelof

full_name: Sylvie Nezelof

given: Sylvie

family: Vulliez-Coady

full_name: Lauriane Vulliez-Coady

given: Lauriane

bso_classification: Social sciences

journal_name: Psychiatry Research

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Behavioral


title: Oculomotor and Neurophysiological Markers of Emotion Regulation and Attachment Styles in Adolescence

summary: The study aims to identify specific visual scanning patterns of attachment pictures in adolescent with different attachment style.

primary_purpose: Basic Science

ReferenceCitation: Szymanska M, Monnin J, Tio G, Vidal C, Girard F, Galdon L, Smith CC, Bifulco A, Nezelof S, Vulliez-Coady L. How do adolescents regulate distress according to attachment style? A combined eye-tracking and neurophysiological approach. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 8;89:39-47. doi: 10.1016/j.pnpbp.2018.08.019. Epub 2018 Aug 27.

family: Vidal

full_name: Chrystelle Vidal

given: Chrystelle

family: Girard

full_name: Frédérique Girard

given: Frédérique

family: Smith

full_name: Carmela Chateau Smith

given: Carmela Chateau

family: Bifulco

full_name: Antonia Bifulco

given: Antonia

journal_name: Progress in Neuro-Psychopharmacology and Biological Psychiatry

ipd_sharing: Undecided


title: Prospective Study on the Interest of ß 1-3 D Glucan Assays in Screening for the Onset of Invasive Aspergillosis in Neutropenic Patients With Acute Leukaemia.

acronym: BETA GLUCAN

summary: In the context of screening for infectious fungal diseases in patients with malignant haemopathy, and particularly patients with acute leukaemia, the investigator aims to evaluate the performance of an already commercialized but little used serum screening test (Fungitell® test) and to determine its place in the management strategy for invasive aspergillosis.

design_allocation: Non-Randomized

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Biological


title: Interest of Eye Movement Measurements in the Comprehension of Dry Eyes Symptoms (BOSO)

acronym: BOSO

summary: Dry eye syndrome is a benign situation however its impact on patient's quality of live and on health system is not trivial. One problem is the lack of correlation between patient's symptoms and physical sign observed on slit lamp examination. Eye blinking is a parameter of increased interest in this pathology particularly its frequency. To date no treatment of dry eye syndrome has a proven impact on eye blinking frequency. However recording of blinks has mostly been performed on short duration (3 to 5 minutes) and the distribution of intervals between 2 blinks is not gaussian but exponential. In this study, it is proposed to use modern eye-movement recorder to measure the blink frequency on longer duration (12 minutes) while reading on a screen computer and during a face-to-face interview before and after treatment of meibomian gland dysfunction responsible of moderate to severe dry eye syndrome.

location_facility: Fondation Ophtalmologique Adolphe de Rothschild (FOR)

intervention_type: Device

lead_sponsor_type: industriel


acronym: CANALHEMO

summary:
The aim of the study is to evaluate the risk in intra-operative nasal hemorrhage when using a "pushed" probe (Master Ka) in the treatment of naso lacrimal duct obstruction (NLDO).

In the investigator's experience, this risk seemed to minus using a pushed probe rather than the classical pulled-type probes.

A lower risk of hemorrhage could lead to a change in the anesthetic procedure. The gold standard in NLDO is the use of an orotracheal intubation. It could then be replaced by the use of an orolaryngeal mask. A forthcoming study will evaluate the results of this anesthetic change.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild

intervention_type: Procedure


title: Phospholipid and Sphingolipid Composition of High-density Lipoproteins (HDL) in Obese Non-diabetic Patients With Metabolic Syndrome

acronym: SPHINGO

summary:
HDL in obese non-diabetic patients show major alterations in their function and thus their cardio-protective effects. These alterations could be explained by the quantitative and qualitative anomalies in the phospholipids and sphingolipids in the HDL. These molecules play a major role in HDL function and probably present early modifications in obesity, even before the onset of glycaemia deregulation.

The aim of this study is to show the presence of qualitative and quantitative modifications of phospholipids and sphingolipids in HDL from obese patients compared with HDL from non-obese controls.

primary_purpose: Other


title: Assessement of the Prevalence of Lysosomal Acid Lipase Deficiency in Liver Post-transplant Patients

summary:
Lysosomal Acid Lipase (LAL) deficiency is a rare, autosomal recessive storage disease linked to decrease enzymatic activity of LAL, responsible for intracellular accumulation of cholesterol esters and triglycerides.

The accumulation of lipid is in hepatocytes, Kupffer cells and macrophages leading to a fatty liver, hepatic fibrosis that can evolve up to cirrhosis.

LAL deficiency is responsible for significant morbidity and early mortality in children, adolescents and adults in connection with a multi visceral disease reaching the liver, gastrointestinal tract and the vascular endothelium. The disease is caused by homozygous or heterozygous mutations in the gene (LIPA chromosome 10q23.2-23.3) which is responsible for the synthesis of the LAL.

The disease can be diagnosed by enzymatic analysis using few drops of blood absorbed onto blotting paper.

Patients with this deficiency LAL, have no or reduced activity of this enzyme. Because of its rarity, the deficit in LAL is under diagnosed or is diagnosed in patients with liver biological disturbances and / or lipid profile disturbances, steatohepatitis-hepatitis (NASH), the steatosis (NAFLD), the cryptogenic cirrhosis or Wilson disease.

Inclusion period of 12 to 18 months (100 patients).


title: Proof of Concept Study Concerning Vestibular Stimulation Using a New Method of Dynamic Posturography.

acronym: POSTURODYN

summary:
Falls in the elderly population are a major public health problem because of their frequency and their consequences, notably in terms of dependence their cost to society. In most cases, balance disorders related to an impaired vestibular system are blamed, even though there is no formal evidence that this is the case.

Vestibular tests in routine otoneurological practice are based on the exploration of vestibulo-ocular or even vestibulo-cortical reflexes. They are not particularly suitable to screen for vestibular disorders in falls.

A prototype rocking chair has been developed to test psycho-vestibular pathways, defined as the pathways via which vestibular afferents are transported to the subject's conscience. Thanks to this apparatus, a stimulus of body movement will be generated, but with limited tactile, visual and proprioceptive afferents, in such a way that the vestibular system alone is able to indicate to subjects their position in space. The subject will be required to detect oscillatory movement, and then to distinguish between a vestibular stimulus and a pulsed auditory stimulus.

The study hypothesis is that the movement stimulation generated by our prototype will be sufficient to stimulate the vestibular system, which will manifest itself as a conscious sensation of movement and by a vestibulo-ocular reflex causing oculomotor manifestations.


title: Prevalence and Risk Factors of Dreentilation Syndrome in a Population of Patients Under Ventilation for Whatever Reason

acronym: DEVENTILATION

summary:
Non-invasive nocturnal ventilation is an effective treatment for chronic respiratory failure, whether due to obstructive (COPD), restrictive or neuromuscular causes, notably for patients in the last two categories for whom it significantly prolongs life expectancy. Overall, the treatment is well tolerated, its principal adverse effects being discomfort related to the mask.

In certain patients, morning dyspnoea when the mask is removed has been described. This is disabling as it limits everyday activities for at least 30 minutes, and defines deventilation syndrome. The pathophysiology of this syndrome is uncertain, notably the roles of hyperinflation, patient/ventilator asynchrony, or the sudden increase in diaphragmatic work after a night of rest.

The aim of this study is to investigate the prevalence of and factors associated with reventilation syndrome (DS) in a population of patients with ventilation whatever the reason, in a stable state, and followed by the medical devices department of Dijon CHU, so as to better understand the mechanisms. Patients with DS will subsequently be invited to participate in a therapeutic trial.


title: Evaluate the Protective Effect of Conditioning With Sevoflurane Versus Propofol on the Myocardium in Scheduled Aortic Valve Replacement Surgery

acronym: SUPRA

summary:
Heart surgery is a considerable source of stress for the myocardium that must be minimized.

Troponin Ic is a reliable marker to determine the level of this myocardial stress.

Studies have shown that post-conditioning with AVH has a protective effect on the myocardium, if the treatment is initiated at the start of the ischemia.

The aim of this study is to evaluate the protective effect on the myocardium (by measuring troponin levels) of the association of pre-conditioning and post-conditioning with Sevoflurane (AVH) sedation administered during and after scheduled surgery for valve replacement, via sternotomy or thoracotomy compared with total intravenous anaesthesia with Propofol.

design_allocation: Randomized

primary_purpose: Treatment

intervention_type: Drug


title: Interest of Spectroscopy in the Diagnosis of Cancerous and Precancerous Lesions of the Upper Airways (UA): Pilot Study

summary:
The detection of suspect lesions is based on the clinical examination of the oral cavity and pharyngolaryngeal endoscopy, but the examination to confirm the diagnosis is a pathology examination of the biopsy taken during the endoscopy. Taking the biopsy, however, can be difficult. On the one hand , it is an invasive procedure, and may engender complications, and on the other hand, certain modifications of the mucosa may be discrete, or not particularly specific or, on the contrary, disseminated or extremely widespread.

Non-invasive tools to help the diagnosis could prove to be particularly interesting 1) to restrict the use of biopsies to patients in whom it is really necessary 2) and to identify the area where the biopsy should be done in cases of multiple lesions. In this context, spectroscopy could be a promising alternative.

The investigator puts forward the hypothesis that cancerous and precancerous lesions of the mucosa of the upper airways and digestive tract present a characteristic spectrometric profile. Indeed, as malignant tumours are hypervascularized and as precancerous tumours show signs of angiogenesis, investigators expect that the reflectance of haemoglobin will be diminished in the specific wavelengths of 540 and 575 nm, corresponding to the principal wavelengths absorbed by haemoglobin.

This pilot study will make it possible to construct an algorithm that could be used to classify lesions of the upper airways and digestive tract as either seemingly benign or cancerous.

primary_purpose: Diagnostic


title: Evaluation Of The Efficacy Of A Bolus Infiltration Of The Anaesthetic Tramadol Associated With Continuous Local Anaesthesia Administered Via A Wound Catheter Following Heart Surgery Via Sternotomy At Dijon Chu Single-Centre, Double-Blind, Randomized, Controlled Clinical Trial

acronym: ATLAS

summary:
Sternotomy, the reference approach for heart surgery, may induce profound and intense post-operative pain. One method of analgesia used is patient-controlled intravenous morphine.

The analgesic efficacy of continuous wound infiltration at the sternum following heart surgery has been demonstrated.

The analgesic catheter placed near the sternotomy wound reduces the consumption of morphine.

The aim of this study is to determine whether a bolus of tramadol associated with the continuous administration of levobupivacaine via the wound catheter could potentiate the local anaesthetic effects, thus leading to a decreased consumption of postoperative intravenous morphine, and a decrease in morphine-related side effects.

ReferenceCitation: Bethenod F, Ellouze O, Berthoud V, Missaoui A, Cransac A, Aho S, Bouchot O, Girard C, Guinot PG, Bouhemad B. A single dose of tramadol in continuous wound analgesia with levobupivacaine does not reduce post-sternotomy pain: a randomized controlled trial. J Pain Res. 2019 Sep 18;12:2733-2741. doi: 10.2147/JPR.S211042. eCollection 2019. Review.

family: Bethenod

full_name: Floriane Bethenod

given: Floriane

family: Ellouze

full_name: Omar Ellouze

given: Omar

family: Berthoud

full_name: Vivien Berthoud

given: Vivien

family: Missaoui

full_name: Anis Missaoui

given: Anis

family: Cransac

full_name: Amélie Cransac

given: Amélie

family: Aho

full_name: Serge Aho

given: Serge

family: Bouchot

full_name: Olivier Bouchot

given: Olivier

full_name: Claude Girard

given: Claude

family: Guinot

full_name: Pierre Grégoire Guinot

given: Pierre Grégoire

family: Bouhemad

full_name: Belaid Bouhemad

given: Belaid

currency_apc_doaj: USD

journal_name: Journal of Pain Research

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa


title: Coordinate Regulation of Transfusions by Uploading

acronym: RTT

summary:
Currently in the Toulouse University Hospital, the organization of transfusion care for patients requiring regular transfusions is based on reading the biological results received by fax before confirming or disproving a planned hospitalization or program a new hospital if needed.

Remote transmission of laboratory results, replacing fax communication might facilitate the coordination of care that results from these laboratory results and provide a better respect of the Plan Custom Care Transfusion (PPST).

The investigators offer organization of transfusion supportive care for patients with conditions requiring biological monitoring using the techniques of information and communication telemedicine.

Primary objective

- Assess the feasibility of setting up an upload procedure biological results in the treatment of transfusion supportive care.

Secondary objectives

Assess the evolution of the quality of life of patients during the treatment
Assess changes in patient satisfaction over the support
Assess the evolution of the satisfaction of the medical team at home and at Toulouse University Hospital
Describe the programming time (hospitalization, consultations)
Estimate the loss of biological results
Assessment of the descriptive use of hospitalization, consultation and biological examinations in both groups. This remedy shall be valued in Euros thanks to GHS rates for hospitalizations, general nomenclature for Professional acts (NGAP) and biology nomenclature (NABM) for biological tests.

lead_sponsor: University Hospital, Toulouse


type: Other Identifier

title: Search for New Genetic Mutations Major Effect in Crohn's Disease

acronym: MC-WES

summary: This study highlight genetics mutations with major effect in Crohn's Disease (CD) by WES in individuals affected and healthy individuals from EPIMAD Inserm InVS registry families.

ReferenceCitation: Frade-Proud'Hon-Clerc S, Smol T, Frenois F, Sand O, Vaillant E, Dhennin V, Bonnefond A, Froguel P, Fumery M, Guillon-Dellac N, Gower-Rousseau C, Vasseur F. A Novel Rare Missense Variation of the NOD2 Gene: Evidencesof Implication in Crohn's Disease. Int J Mol Sci. 2019 Feb 15;20(4). pii: E835. doi: 10.3390/ijms20040835.

apc_source: openAPC

family: Frade-Proud’Hon-Clerc

full_name: Sara Frade-Proud’Hon-Clerc

given: Sara

family: Smol

full_name: Thomas Smol

given: Thomas

family: Frenois

full_name: Frédéric Frenois

given: Frédéric

family: Sand

full_name: Olivier Sand

family: Vaillant

full_name: Emmanuel Vaillant

given: Emmanuel

family: Dhennin

full_name: Véronique Dhennin

given: Véronique

family: Bonnefond

full_name: Amélie Bonnefond

family: Froguel

full_name: Philippe Froguel

given: Philippe

family: Fumery

full_name: Mathurin Fumery

given: Mathurin

family: Guillon-Dellac

full_name: Nathalie Guillon-Dellac

given: Nathalie

family: Gower-Rousseau

full_name: Corinne Gower-Rousseau

given: Corinne

family: Vasseur

full_name: Francis Vasseur

given: Francis

currency_apc_doaj: CHF

journal_name: International Journal of Molecular Sciences

license: cc-by

license_normalized: cc-by

evidence: oa repository (via page says license)

version: submittedVersion

repository_institution: Imperial College London - Spiral

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

repository_normalized: HAL

repository_institution: Université de Lille (University Of Lille) - LillOA

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

title: A Novel Rare Missense Variation of the NOD2 Gene: Evidencesof Implication in Crohn’s Disease


title: Study of Neurophysiological Correlates of the Link Between Perception and Action Through Varied Protocols of Sensorimotor Studies

summary: The main goal of this study is to better understand the link between motor system (action) and perception in variable sensorial forms by examining the time course and the dynamic of electroencephalography (EEG) activations. To do so, differents sensimotor study protocols in linguistics and in the fiels of emotional and spatial perception will be realised in order to study prcisely differents links parception-action.

status: Recruiting

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ReferenceCitation: Vermeulen N, Pleyers G, Mermillod M. Second-person social neuroscience: connections to past and future theories, methods, and findings. Behav Brain Sci. 2013 Aug;36(4):440-1. doi: 10.1017/S0140525X12002075.

ReferenceCitation: Vermeulen N, Chang B, Corneille O, Pleyers G, Mermillod M. Verifying properties of concepts spontaneously requires sharing resources with same-modality percept. Cogn Process. 2013 Mar;14(1):81-7. doi: 10.1007/s10339-012-0533-1. Epub 2013 Feb 15.

lead_sponsor: University Hospital, Grenoble

status_simplified: Ongoing


title: Protected by Nature: Could Physical Activity Help to Counteract the Blood Haemophilia Disturbance? A Pilot Study.

acronym: END-HEMO

summary:
Physical activity is lower in patients with haemophilia than in their healthy peers. Nevertheless, exercize is recommended for those patients and supported by evidence. Until 2013, scientific and medical evidence to encourage physical activity for patients with haemophilia were listed to increase their locomotor function, their metabolic status, their fitness level and their well-being. In 2013, an original publication by Groen et al. suggested that physical activity could also interact with the specific and biological disturbance of the disease.

We propose to consider that regular endurance exercize prescription should be encouraged in patients with haemophilia not only for a healthier lifestyle but also because it could positively alter the specific biological blood disturbance seen in haemophilia. Nevertheless, before planning a well powered intervention trial we need to determine the acceptability of regular exercize and the expected value of factor Factor VIII, von Willebrand factor and von Willebrand propeptide after an endurance training program.


title: Portal Hypertension and Systemic Endothelial Function: Investigation of Systemic Endothelial Dysfunction in Case of Portal Hypertension Associated With Cystic Fibrosis.

acronym: ENDOTH-MUCO

summary:
Cystic fibrosis can affect organs other than the lungs. Liver disease affects about 30% of patients: its main manifestation is the development of portal hypertension (PHT). The pathophysiology of this comorbidity is still poorly understood. It was previously considered secondary to the formation of biliary cirrhosis but another hypothesis would be that of a primitive pathology of venous vessels may cause the gradual emergence of portal hypertension without cirrhosis. Evidence indiscutly suggest that cystic fibrosis is associated with a specific endothelial dysfunction, especially as the CFTR (Cystic Fibrosis Transmembrane conductance Regulator) protein is expressed on the surface of endothelial cells. The investigators hypothesize that liver disease related to PHT-associated cystic fibrosis is associated with systemic endothelial dysfunction.

The aim is:

To demonstrate a systemic endothelial dysfunction in patients with cystic fibrosis when associated with PHT.

To study the correlations between measures of systemic endothelial function and serum markers of endothelial dysfunction and between measures of liver stiffness and systemic endothelial function.

primary_purpose: Prevention

lead_sponsor: Hopital Foch


title: Contribution of Fast Molecular Bacterial Identification by Real-time PCR in Managing of Postoperative Acute Endophthalmitis

acronym: Targeted PCR

summary:
Endophthalmitis is a serious eye infection of exogenous origin (post-operational, post-traumatic) or endogenous origin (metastatic). This is a diagnostic and therapeutic emergency.

Each patient suffering from endophthalmitis must have immediately an ocular sampling, an intra ocular injection of antibiotics and a systemic antibiotic cover.

The etiological treatment will be adapted according to the infectious agent.

ReferenceCitation: Microbiologic factors and visual outcome in the endophthalmitis vitrectomy study. Am J Ophthalmol. 1996 Dec;122(6):830-46.

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title: Spatial Orientation and Motor Skills: How to Flip Switches "Down" in Weightlessness?

acronym: Down

summary:
The purpose of the study is to investigate spatial orientation in weightlessness as it manifests not in perception but rather in motor performance by direction and reaction time of flip switch.

Hypotheses are that flip switch:

will be biased towards visual allocentric cues when those are available;
will be biased towards the egocentric reference when tactile cues are added;
will be dominated by egocentric cues when visual cues are not available;
will be delayed and more variable when confirmatory gravitational cues are absent;
will be faster and more reliable in absence of conflicting gravitational cues, and even more so when tactile cues are added;
The difference will be more pronounce when tested under Dual-task condition

lead_sponsor: University Hospital, Caen


title: The Effect of NO Precursors on Physiological Responses to Exercise

acronym: NO-SUP

summary: NO is an ubiquitous molecule contributing to many physiological functions such as vasodilation, immune and oxidative stress responses. NO production can be supplemented either by providing substrate to the NO-synthase (L-Arginine and L-Citruline) or by providing nitrate which can lead to NO. In the present project the investigators evaluate the effect of various acute and chronic oral NO precursors supplementation on exercise performance and responses in healthy young and older subjects.

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intervention_type: Dietary Supplement


title: Gas Exchange and Cardiovascular Kinetics of Regulation - Effects of Short Term Changes in Gravity

acronym: GasEx

summary:
The regulation of the cardiovascular respiratory system after changing environmental conditions or changes in work rates are essential for cognitive as well as physical functioning. For decades, it is known that high level of headward acceleration (+Gz) impairs cardiovascular function that may cause loss of consciousness. Some "anti-g" maneuvers, such as muscle contraction of the lower extremities and buttocks or intermittent exhalation on exertion (i.e., exhalation against a closed airway) have been proved to increase tolerance to high +Gz.

Main objective of this experiment is to investigate the effects of anti-g maneuvers on cardiovascular and respiratory tolerance to the push-pull-effect.

Cardiovascular and respiratory functions will be evaluated with the following parameters: heart rate, stroke volume, cardiac output, blood pressure, oxygen uptake, carbon dioxide output, ventilation, breathing frequency, body core temperature.

Electromyography (EMG) will not be a judgment criteria but will be used to check the quality of 'muscle contraction' anti-g maneuver.

The main hypothesis is that anti-g maneuvers will increase cardiovascular and respiratory tolerance to the push-pull effect, especially when they are combined.


title: Muscular Force Generation in Microgravity (ForceGeneration)

acronym: ForceGeneratio

summary:
The aim of this study is to evaluate the applicability of high-load resistance training as a countermeasure for long term space flights, the current project has two scientific goals.

The main objective is to perform a deeper examination of muscle function and MVC in weightlessness (parabolic flight).

The secondary objective is to gather further insight into the underlying mechanisms and structures based on investigations targeting the neuromuscular and musculotendinous systems and their interaction.


title: Assessment Of Intracoronary Thrombus By Optical Frequency Domain Imaging During Percutaneous Coronary Intervention After Successful Fibrinolysis And Its Impact On Myocardial Reperfusion

acronym: AODIS

summary:
The pharmacoinvasive approach after thrombolysis is the standard treatment of myocardial infarction when deadlines are too long for primary angioplasty. Coronary angioplasty is then carried out within 3 to 24 hours following thrombolysis. The adjuvant antiplatelet therapy of thrombolysis combines aspirin with clopidogrel (75 or 300 mg depending on age). These clopidogrel doses are associated with a very low anti-platelet aggregation response within 24 hours following administration. However, the antiplatelet agregation that inhibits the progression of intracoronary thrombus must be optimal at the time of angioplasty to reduce the risk of thrombotic events. Intracoronary thrombus residual angiographic post-thrombolysis was associated with impaired myocardial reperfusion but coronary angiography has a very low sensitivity for detecting the thrombus. The optical coherence tomography (OCT) is currently the method of choice to visualize and quantify the intracoronary thrombus. It is used routinely in the presence of a thrombus to correctly estimate the size of the artery and for the evaluation of good stent apposition.

The thrombectomy at the time of angioplasty improves myocardial reperfusion, particularly in case of major thrombotic mass. Intracoronary thrombus residual post-thrombolysis could be a marker for the quality of reperfusion itself correlated to the quality of the antiplatelet post-thrombolysis.

The investigators therefore hypothesize that the systematic use of the OCT before elective angioplasty (within 3 to 24 hours) after successful thrombolysis could be used to guide the use of thrombectomy and adequate stenting and thus improve myocardial reperfusion. Our study will also correlate the importance of the residual thrombus before angioplasty myocardial reperfusion one hand and to the inhibition of platelet activity observed other.

time_perspective: Cross-Sectional


title: Use of Genetically Modified T-lymphocytes Expressing the Inducible Human Caspase 9 Gene (iCASP9) and the Selection Gene ΔCD19 in Allogeneic Haematopoietic Transplantation.

summary: This study evaluates the frequency of occurrence, severity, and response to treatment by a chemical agent, notably the dimerizer AP1903 (Bellicum Pharmaceuticals compagny), in the case of acute Graft versus Host Disease (aGvHD) occurring after the administration of T-lymphocytes expressing iCASP9 and concomitantly to a bone marrow graft depleted in B- and T-lymphocytes

ipd_sharing: Yes


title: Long Term Cornea Graft Survival Study (Étude Bisontine d'Estimation de la Survie à Long Terme à Partir Des données de Suivi Internes au CHRU : Evaluation Epidémiologie Clinique)

acronym: BELIEvE

summary:
Corneal transplantation have been performed for several decades, follow-up time in some centers now exceeds 30 years. Published long term (10 years and up) graft survivals vary considerably from center to center. These variations may be explained by differences in case-mix and surgical techniques used.

The investigators aim to better understand the factors associated with long term graft survival.

ReferenceCitation: Bidaut-Garnier M, Monnet E, Prongué A, Montard R, Gauthier AS, Desmarets M, Mariet AS, Ratajczak C, Binda D, Saleh M, Delbosc B. Evolution of Corneal Graft Survival Over a 30-Year Period and Comparison of Surgical Techniques: A Cohort Study. Am J Ophthalmol. 2016 Mar;163:59-69. doi: 10.1016/j.ajo.2015.12.014. Epub 2015 Dec 17.

family: Bidaut-Garnier

full_name: Mélanie Bidaut-Garnier

given: Mélanie

family: Monnet

full_name: Elisabeth Monnet

given: Elisabeth

family: Prongué

full_name: Aurélien Prongué

given: Aurélien

family: Montard

full_name: Romain Montard

given: Romain

family: Gauthier

full_name: Anne-Sophie Gauthier

given: Anne-Sophie

family: Desmarets

full_name: Maxime Desmarets

given: Maxime

family: Mariet

full_name: Anne-Sophie Mariet

family: Ratajczak

full_name: Charlène Ratajczak

given: Charlène

family: Binda

full_name: Delphine Binda

given: Delphine

family: Saleh

full_name: Maher Saleh

given: Maher

family: Delbosc

full_name: Bernard Delbosc

given: Bernard

journal_name: American Journal of Ophthalmology


title: Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis and Assessment of Their Relations With the Risk of Cardiovascular Disease

acronym: ADIPSO

summary:
Body composition analysis and especially body fat distribution in regions of interest (android and in particular intra-abdominal region) provides some information on the risk of cardiovascular disease. There is little data available on the body composition analysis in psoriasis and psoriatic arthritis (diseases with higher risk of cardiovascular disease), in particular data on fat distribution in regions of interest regarding the risk of cardiovascular disease.

Adipokines, secreted by the adipose tissue, have pro or anti-inflammatory and metabolic properties that are interesting to explore in pathologies with a higher risk of cardiovascular disease like psoriasis or psoriatic arthritis.

Adipokines have been investigated in psoriasis but fat tissue and in particular its distribution (android/visceral or intra-abdominal) has not been studied in parallel. Moreover, relation between adipokines and psoriasis area or severity has been studied but the relation between adipokines and cardiovascular risk factors has not yet been investigated.

The aim of this study is to investigate relations between the body fat distribution, adipokines rates and the risk of cardiovascular disease of these patients.

ReferenceCitation: Toussirot E, Aubin F, Desmarets M, Wendling D, Augé B, Gillard J, Messica O, Guillot X, Laheurte C, Monnet E, Dumoulin G. Visceral adiposity in patients with psoriatic arthritis and psoriasis alone and its relationship with metabolic and cardiovascular risk. Rheumatology (Oxford). 2021 Jun 18;60(6):2816-2825. doi: 10.1093/rheumatology/keaa720.

name: INSERM CIC-1431, Centre d’Investigation Clinique Biothérapie, Pôle Recherche, Besançon, France

name: Fédération Hospitalo-Universitaire INCREASE, Besançon, France

name: Rhumatologie, Pôle PACTE (Pathologies Aiguës Chroniques Transplantation Éducation), CHU de Besançon, Besançon, France

name: Département Universitaire de Thérapeutique, Université de Bourgogne Franche-Comté, Besançon, France

name: INSERM UMR1098 “Relations Hôte Greffon Tumeurs, ingénierie cellulaire et génique”, Université de Bourgogne Franche-Comté, Besançon, France

family: Toussirot

full_name: Eric Toussirot

given: Eric

name: Dermatologie, CHU de Besançon, Besançon, France

family: Aubin

full_name: François Aubin

given: François

name: Unité de méthodologie uMETh, INSERM CIC-1431, Centre d’Investigation Clinique, CHU de Besançon, Besançon, France

name: EA 4266 EPILAB, Université Bourgogne Franche-Comté, Besançon, France

family: Wendling

full_name: Daniel Wendling

given: Daniel

name: Cabinet de rhumatologie de Palente, Besançon, France

family: Augé

full_name: Benoit  Augé

given: Benoit

name: Rhumatologie, Centre Hospitalier Jura Sud, Lons le Saunier, France

family: Gillard

full_name: Jérome Gillard

given: Jérome

name: Rhumatologie, Groupe Hospitalier de Haute Saône, Vesoul, France

family: Messica

full_name: Olivier Messica

given: Olivier

name: Rhumatologie, CHU de la Réunion, Saint Denis de la Réunion, France

family: Guillot

full_name: Xavier Guillot

given: Xavier

family: Laheurte

full_name: Caroline Laheurte

given: Caroline

full_name: Elisabeth  Monnet

name: Laboratoire de Biochimie Médicale, UF de Biochimie Endocrinienne et Métabolique, CHU de Besançon et EA 3920 Marqueurs pronostiques et facteurs de régulation des pathologies cardiaques et vasculaires, Université de Bourgogne Franche Comté, Besançon, France

family: Dumoulin

full_name: Gilles Dumoulin

given: Gilles

journal_name: Rheumatology

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press