title: Angioplasty of Distal Lesions for Carriers of Inoperable Post-embolic HTP

summary:
Currently, the standard treatment for proximal thromboses lesions responsible for post-embolic pulmonary hypertension, is the surgical thromboendarterectomy. When the ravages are judged too distal or the patient is judged inoperable for a curative surgical gesture, there is no evidence of any therapeutic option, exept for K anti-vitamins for recurrent embolism. Prognosis is then pejorative with a 60% mortality at 5 years.

This study propose an alternative treatment for these patients in therapeutic "dead end". This is about applying arterial thrombosis technique to the pulmonary circulation.

ReferenceCitation: Mizoguchi H, Ogawa A, Munemasa M, Mikouchi H, Ito H, Matsubara H. Refined balloon pulmonary angioplasty for inoperable patients with chronic thromboembolic pulmonary hypertension. Circ Cardiovasc Interv. 2012 Dec;5(6):748-55. doi: 10.1161/CIRCINTERVENTIONS.112.971077. Epub 2012 Nov 27.

ReferenceCitation: Sugimura K, Fukumoto Y, Satoh K, Nochioka K, Miura Y, Aoki T, Tatebe S, Miyamichi-Yamamoto S, Shimokawa H. Percutaneous transluminal pulmonary angioplasty markedly improves pulmonary hemodynamics and long-term prognosis in patients with chronic thromboembolic pulmonary hypertension. Circ J. 2012;76(2):485-8. Epub 2011 Dec 15.

ReferenceCitation: Fukumoto Y, Shimokawa H. Recent progress in the management of pulmonary hypertension. Circ J. 2011;75(8):1801-10. Epub 2011 Jul 11. Review.

ReferenceCitation: Feinstein JA, Goldhaber SZ, Lock JE, Ferndandes SM, Landzberg MJ. Balloon pulmonary angioplasty for treatment of chronic thromboembolic pulmonary hypertension. Circulation. 2001 Jan 2;103(1):10-3.

ReferenceCitation: Jaïs X, D'Armini AM, Jansa P, Torbicki A, Delcroix M, Ghofrani HA, Hoeper MM, Lang IM, Mayer E, Pepke-Zaba J, Perchenet L, Morganti A, Simonneau G, Rubin LJ; Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension Study Group. Bosentan for treatment of inoperable chronic thromboembolic pulmonary hypertension: BENEFiT (Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension), a randomized, placebo-controlled trial. J Am Coll Cardiol. 2008 Dec 16;52(25):2127-34. doi: 10.1016/j.jacc.2008.08.059.

family: Jaïs

full_name: Xavier Jaïs

given: Xavier

family: D'Armini

full_name: Andrea M. D'Armini

given: Andrea M.

family: Jansa

full_name: Pavel Jansa

given: Pavel

family: Torbicki

full_name: Adam Torbicki

given: Adam

family: Delcroix

full_name: Marion Delcroix

given: Marion

family: Ghofrani

full_name: Hossein A. Ghofrani

given: Hossein A.

family: Hoeper

full_name: Marius M. Hoeper

given: Marius M.

family: Lang

full_name: Irene M. Lang

given: Irene M.

family: Mayer

full_name: Eckhard Mayer

given: Eckhard

family: Pepke-Zaba

full_name: Joanna Pepke-Zaba

given: Joanna

family: Perchenet

full_name: Loïc Perchenet

given: Loïc

family: Morganti

full_name: Adele Morganti

given: Adele

family: Simonneau

full_name: Gérald Simonneau

given: Gérald

family: Rubin

full_name: Lewis J. Rubin

given: Lewis J.

journal_name: Journal of the American College of Cardiology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: Bosentan for Treatment of Inoperable Chronic Thromboembolic Pulmonary Hypertension

ReferenceCitation: Diggle PJ, Liang KY, Zeger SL. Analysis of longitudinal data. New York: Oxfiord University Press, 2000.

ReferenceCitation: Twisk JWR. Applied longitudinal analysis for epidemiology. Cambridge: Cambridge University Press, 2003.

ReferenceCitation: Mayer E, Jenkins D, Lindner J, D'Armini A, Kloek J, Meyns B, Ilkjaer LB, Klepetko W, Delcroix M, Lang I, Pepke-Zaba J, Simonneau G, Dartevelle P. Surgical management and outcome of patients with chronic thromboembolic pulmonary hypertension: results from an international prospective registry. J Thorac Cardiovasc Surg. 2011 Mar;141(3):702-10. doi: 10.1016/j.jtcvs.2010.11.024.

ReferenceCitation: Pepke-Zaba J, Jansa P, Kim NH, Naeije R, Simonneau G. Chronic thromboembolic pulmonary hypertension: role of medical therapy. Eur Respir J. 2013 Apr;41(4):985-90. doi: 10.1183/09031936.00201612. Epub 2013 Feb 8. Review.

ReferenceCitation: de Perrot M, McRae K, Shargall Y, Pletsch L, Tan K, Slinger P, Ma M, Paul N, Moric J, Thenganatt J, Mak S, Granton JT. Pulmonary endarterectomy for chronic thromboembolic pulmonary hypertension: the Toronto experience. Can J Cardiol. 2011 Nov-Dec;27(6):692-7. doi: 10.1016/j.cjca.2011.09.009. Epub 2011 Oct 21.

ReferenceCitation: Inami T, Kataoka M, Shimura N, Ishiguro H, Yanagisawa R, Taguchi H, Fukuda K, Yoshino H, Satoh T. Pulmonary edema predictive scoring index (PEPSI), a new index to predict risk of reperfusion pulmonary edema and improvement of hemodynamics in percutaneous transluminal pulmonary angioplasty. JACC Cardiovasc Interv. 2013 Jul;6(7):725-36. doi: 10.1016/j.jcin.2013.03.009. Epub 2013 Jun 14.

lead_sponsor: University Hospital, Grenoble


title: Biomarkers in Giant Cells Arteritis

acronym: BioACG

summary:
Giant cells arteritis or Horton disease is a vasculitis that affects great vessels. This is the most frequent vasculitis of the population over the age of 50. This vasculitis is at the origin of an inflammatory infiltrate of arterial tunics, essentially composed of lymphocytes. Clinical signs are a deterioration of general state, unusual cephalgias, jaw pain, scalp hyperesthesia, but can also be serious ischemic complication, especially ophthalmologic with the possibility to go blind. Until now, the standard treatment is a high dosage corticosteroid therapy.

Diagnosis is based on criterias of the American College of Rheumatology, dating back to 1990. The relapse rate is important, ranging from 10 to 64 % according to studies. There are also issues of becoming dependent on steroid.

So it is important to determine new diagnosis markers and a therapeutic following of giant cells arteritis.

With this study several biomarkers of inflammation will be studied in order to determine if one ore many of them have a good sensitivity and special feature for diagnosis and following of giant cells arteritis.

The main goal is to determine a new diagnosis marker for giant cells arteritis.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Hachulla E, Boivin V, Pasturel-Michon U, Fauchais AL, Bouroz-Joly J, Perez-Cousin M, Hatron PY, Devulder B. Prognostic factors and long-term evolution in a cohort of 133 patients with giant cell arteritis. Clin Exp Rheumatol. 2001 Mar-Apr;19(2):171-6.

ReferenceCitation: Graham E, Holland A, Avery A, Russell RW. Prognosis in giant-cell arteritis. Br Med J (Clin Res Ed). 1981 Jan 24;282(6260):269-71.

ReferenceCitation: Alba MA, García-Martínez A, Prieto-González S, Tavera-Bahillo I, Corbera-Bellalta M, Planas-Rigol E, Espígol-Frigolé G, Butjosa M, Hernández-Rodríguez J, Cid MC. Relapses in patients with giant cell arteritis: prevalence, characteristics, and associated clinical findings in a longitudinally followed cohort of 106 patients. Medicine (Baltimore). 2014 Jul;93(5):194-201. doi: 10.1097/MD.0000000000000033.

ReferenceCitation: Proven A, Gabriel SE, Orces C, O'Fallon WM, Hunder GG. Glucocorticoid therapy in giant cell arteritis: duration and adverse outcomes. Arthritis Rheum. 2003 Oct 15;49(5):703-8.

ReferenceCitation: Maffioli L, Mazzone A. Giant-cell arteritis and polymyalgia rheumatica. N Engl J Med. 2014 Oct 23;371(17):1652-3. doi: 10.1056/NEJMc1409206.

ReferenceCitation: Kermani TA, Schmidt J, Crowson CS, Ytterberg SR, Hunder GG, Matteson EL, Warrington KJ. Utility of erythrocyte sedimentation rate and C-reactive protein for the diagnosis of giant cell arteritis. Semin Arthritis Rheum. 2012 Jun;41(6):866-71. doi: 10.1016/j.semarthrit.2011.10.005. Epub 2011 Nov 25.

ReferenceCitation: Laria A, Zoli A, Bocci M, Castri F, Federico F, Ferraccioli GF. Systematic review of the literature and a case report informing biopsy-proven giant cell arteritis (GCA) with normal C-reactive protein. Clin Rheumatol. 2012 Sep;31(9):1389-93. doi: 10.1007/s10067-012-2031-3. Epub 2012 Jul 22. Review.

ReferenceCitation: Yoeruek E, Szurman P, Tatar O, Weckerle P, Wilhelm H. Anterior ischemic optic neuropathy due to giant cell arteritis with normal inflammatory markers. Graefes Arch Clin Exp Ophthalmol. 2008 Jun;246(6):913-5. doi: 10.1007/s00417-007-0762-7. Epub 2008 Apr 2.

ReferenceCitation: Kyle V, Cawston TE, Hazleman BL. Erythrocyte sedimentation rate and C reactive protein in the assessment of polymyalgia rheumatica/giant cell arteritis on presentation and during follow up. Ann Rheum Dis. 1989 Aug;48(8):667-71.

ReferenceCitation: Kieffer P, Hinschberger O, Ciobanu E, Jaeger-Bizet F, Drabo A, Mostoufizadeh T, Martzolff L. [Clinical and biological efficacy of tocilizumab in giant cell arteritis: report of three patients and literature review]. Rev Med Interne. 2014 Jan;35(1):56-9. doi: 10.1016/j.revmed.2012.12.012. Epub 2013 Sep 26. Review. French.

ReferenceCitation: Salvarani C, Magnani L, Catanoso M, Pipitone N, Versari A, Dardani L, Pulsatelli L, Meliconi R, Boiardi L. Tocilizumab: a novel therapy for patients with large-vessel vasculitis. Rheumatology (Oxford). 2012 Jan;51(1):151-6. doi: 10.1093/rheumatology/ker296. Epub 2011 Nov 10.

ReferenceCitation: Unizony S, Arias-Urdaneta L, Miloslavsky E, Arvikar S, Khosroshahi A, Keroack B, Stone JR, Stone JH. Tocilizumab for the treatment of large-vessel vasculitis (giant cell arteritis, Takayasu arteritis) and polymyalgia rheumatica. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1720-9. doi: 10.1002/acr.21750.

ReferenceCitation: Samson M, Bonnotte B. [Giant-cell arteritis pathogenesis]. Presse Med. 2012 Oct;41(10):937-47. doi: 10.1016/j.lpm.2012.07.005. Epub 2012 Aug 14. Review. French.

ReferenceCitation: Martinez-Taboada VM, Alvarez L, RuizSoto M, Marin-Vidalled MJ, Lopez-Hoyos M. Giant cell arteritis and polymyalgia rheumatica: role of cytokines in the pathogenesis and implications for treatment. Cytokine. 2008 Nov;44(2):207-20. doi: 10.1016/j.cyto.2008.09.004. Epub 2008 Nov 4. Review.

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

family: Ly

full_name: K.-H. Ly

sequence: first

family: Liozon

full_name: E. Liozon

given: E.

sequence: additional

family: Fauchais

full_name: A.-L. Fauchais

family: Vidal

full_name: E. Vidal

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: La Revue de Médecine Interne

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Physiopathologie de l’artérite à cellules géantes

ReferenceCitation: Ly KH, Régent A, Tamby MC, Mouthon L. Pathogenesis of giant cell arteritis: More than just an inflammatory condition? Autoimmun Rev. 2010 Aug;9(10):635-45. doi: 10.1016/j.autrev.2010.05.002. Epub 2010 May 8. Review.

ReferenceCitation: Weyand CM, Younge BR, Goronzy JJ. IFN-γ and IL-17: the two faces of T-cell pathology in giant cell arteritis. Curr Opin Rheumatol. 2011 Jan;23(1):43-9. doi: 10.1097/BOR.0b013e32833ee946. Review.

ReferenceCitation: Visvanathan S, Rahman MU, Hoffman GS, Xu S, García-Martínez A, Segarra M, Lozano E, Espígol-Frigolé G, Hernández-Rodríguez J, Cid MC. Tissue and serum markers of inflammation during the follow-up of patients with giant-cell arteritis--a prospective longitudinal study. Rheumatology (Oxford). 2011 Nov;50(11):2061-70. doi: 10.1093/rheumatology/ker163. Epub 2011 Aug 25.

ReferenceCitation: García-Martínez A, Hernández-Rodríguez J, Espígol-Frigolé G, Prieto-González S, Butjosa M, Segarra M, Lozano E, Cid MC. Clinical relevance of persistently elevated circulating cytokines (tumor necrosis factor alpha and interleukin-6) in the long-term followup of patients with giant cell arteritis. Arthritis Care Res (Hoboken). 2010 Jun;62(6):835-41. doi: 10.1002/acr.20043.

ReferenceCitation: Ma-Krupa W, Jeon MS, Spoerl S, Tedder TF, Goronzy JJ, Weyand CM. Activation of arterial wall dendritic cells and breakdown of self-tolerance in giant cell arteritis. J Exp Med. 2004 Jan 19;199(2):173-83.

ReferenceCitation: Samson M, Audia S, Martin L, Janikashvili N, Bonnotte B. Pathogenesis of giant cell arteritis: new insight into the implication of CD161+ T cells. Clin Exp Rheumatol. 2013 Jan-Feb;31(1 Suppl 75):S65-73. Epub 2013 Apr 19. Review.

ReferenceCitation: Samson M, Audia S, Fraszczak J, Trad M, Ornetti P, Lakomy D, Ciudad M, Leguy V, Berthier S, Vinit J, Manckoundia P, Maillefert JF, Besancenot JF, Aho-Glele S, Olsson NO, Lorcerie B, Guillevin L, Mouthon L, Saas P, Bateman A, Martin L, Janikashvili N, Larmonier N, Bonnotte B. Th1 and Th17 lymphocytes expressing CD161 are implicated in giant cell arteritis and polymyalgia rheumatica pathogenesis. Arthritis Rheum. 2012 Nov;64(11):3788-98. doi: 10.1002/art.34647.

ReferenceCitation: Lachmann HJ, Goodman HJ, Gilbertson JA, Gallimore JR, Sabin CA, Gillmore JD, Hawkins PN. Natural history and outcome in systemic AA amyloidosis. N Engl J Med. 2007 Jun 7;356(23):2361-71.

ReferenceCitation: Hachulla E, Saile R, Parra HJ, Hatron PY, Gosset D, Fruchart JC, Devulder B. Serum amyloid A concentrations in giant-cell arteritis and polymyalgia rheumatica: a useful test in the management of the disease. Clin Exp Rheumatol. 1991 Mar-Apr;9(2):157-63.

ReferenceCitation: Blume JD. Bounding Sample Size Projections for the Area Under a ROC Curve. J Stat Plan Inference. 2009 Mar 1;139(1):711-721.

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Prospective Study to Quantify the Change in Weight at a Pneumonia

acronym: PneumoniePoids

summary:
This study is based on the change in weight of hospitalized patients knowing that the diagnosis of malnutrition based on the presence of at least one clinical or laboratory test which anthropometric measures (Evaluation of diagnostic protein energy malnutrition in hospitalized adults ANAES , Guidelines Department, September 2003; HAS Strategy supported in cases of wasting energy and protein in the elderly April 2007).

The goal of this study is to find the correlation between hospitalization and weight loss, significant risk factors for malnutrition in a situation of community-acquired pneumonia infection.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceCitation: Arnone D, Cavanagh J, Gerber D, Lawrie SM, Ebmeier KP, McIntosh AM. Magnetic resonance imaging studies in bipolar disorder and schizophrenia: meta-analysis. Br J Psychiatry. 2009 Sep;195(3):194-201. doi: 10.1192/bjp.bp.108.059717. Review.

ReferenceCitation: Bamford S, Ward R. Predispositions to approach and avoid are contextually sensitive and goal dependent. Emotion. 2008 Apr;8(2):174-83. doi: 10.1037/1528-3542.8.2.174.

ReferenceCitation: Bradley MM, Sabatinelli D, Lang PJ, Fitzsimmons JR, King W, Desai P. Activation of the visual cortex in motivated attention. Behav Neurosci. 2003 Apr;117(2):369-80.

ReferenceCitation: Bradley MM. Natural selective attention: orienting and emotion. Psychophysiology. 2009 Jan;46(1):1-11. doi: 10.1111/j.1469-8986.2008.00702.x. Epub 2008 Sep 5. Review.

ReferenceCitation: Briggs KE, Martin FH. Target processing is facilitated by motivationally relevant cues. Biol Psychol. 2008 Apr;78(1):29-42. doi: 10.1016/j.biopsycho.2007.12.007. Epub 2008 Jan 4.

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ReferenceCitation: Cirillo MA, Seidman LJ. Verbal declarative memory dysfunction in schizophrenia: from clinical assessment to genetics and brain mechanisms. Neuropsychol Rev. 2003 Jun;13(2):43-77. Review.

ReferenceCitation: Delplanque S, Lavoie ME, Hot P, Silvert L, Sequeira H. Modulation of cognitive processing by emotional valence studied through event-related potentials in humans. Neurosci Lett. 2004 Feb 6;356(1):1-4.

ReferenceCitation: Ellison-Wright I, Glahn DC, Laird AR, Thelen SM, Bullmore E. The anatomy of first-episode and chronic schizophrenia: an anatomical likelihood estimation meta-analysis. Am J Psychiatry. 2008 Aug;165(8):1015-23. doi: 10.1176/appi.ajp.2008.07101562. Epub 2008 Apr 1.

ReferenceCitation: Goldman-Rakic PS. Working memory dysfunction in schizophrenia. J Neuropsychiatry Clin Neurosci. 1994 Fall;6(4):348-57. Review.

ReferenceCitation: Frijda, N.H. (1986). The emotions. Cambridge et New-York: Cambridge University Press.

ReferenceCitation: Frijda, N.H. (1987). Emotions, cognitive structure, and action tendency. Cognition and Emotion, 1, 115-143.

ReferenceCitation: Glahn DC, Laird AR, Ellison-Wright I, Thelen SM, Robinson JL, Lancaster JL, Bullmore E, Fox PT. Meta-analysis of gray matter anomalies in schizophrenia: application of anatomic likelihood estimation and network analysis. Biol Psychiatry. 2008 Nov 1;64(9):774-81. doi: 10.1016/j.biopsych.2008.03.031. Epub 2008 May 16.

ReferenceCitation: Hajcak G, Dunning JP, Foti D. Motivated and controlled attention to emotion: time-course of the late positive potential. Clin Neurophysiol. 2009 Mar;120(3):505-10. doi: 10.1016/j.clinph.2008.11.028. Epub 2009 Jan 20.

ReferenceCitation: Hajcak G, Moser JS, Simons RF. Attending to affect: appraisal strategies modulate the electrocortical response to arousing pictures. Emotion. 2006 Aug;6(3):517-22.

ReferenceCitation: Hajcak G, Molnar C, George MS, Bolger K, Koola J, Nahas Z. Emotion facilitates action: a transcranial magnetic stimulation study of motor cortex excitability during picture viewing. Psychophysiology. 2007 Jan;44(1):91-7.

ReferenceCitation: Harmon-Jones E, Lueck L, Fearn M, Harmon-Jones C. The effect of personal relevance and approach-related action expectation on relative left frontal cortical activity. Psychol Sci. 2006 May;17(5):434-40.

ReferenceCitation: Honea R, Crow TJ, Passingham D, Mackay CE. Regional deficits in brain volume in schizophrenia: a meta-analysis of voxel-based morphometry studies. Am J Psychiatry. 2005 Dec;162(12):2233-45. Review.

ReferenceCitation: Ha TH, Youn T, Ha KS, Rho KS, Lee JM, Kim IY, Kim SI, Kwon JS. Gray matter abnormalities in paranoid schizophrenia and their clinical correlations. Psychiatry Res. 2004 Dec 30;132(3):251-60.

ReferenceCitation: Ito TA, Larsen JT, Smith NK, Cacioppo JT. Negative information weighs more heavily on the brain: the negativity bias in evaluative categorizations. J Pers Soc Psychol. 1998 Oct;75(4):887-900.

ReferenceCitation: Kasanin J. The acute schizoaffective psychoses. 1933. Am J Psychiatry. 1994 Jun;151(6 Suppl):144-54.

ReferenceCitation: Maier W, Zobel A, Wagner M. Schizophrenia and bipolar disorder: differences and overlaps. Curr Opin Psychiatry. 2006 Mar;19(2):165-70. Review.

ReferenceCitation: McDonald C, Bullmore E, Sham P, Chitnis X, Suckling J, MacCabe J, Walshe M, Murray RM. Regional volume deviations of brain structure in schizophrenia and psychotic bipolar disorder: computational morphometry study. Br J Psychiatry. 2005 May;186:369-77.

ReferenceCitation: Ochsner KN, Gross JJ. The cognitive control of emotion. Trends Cogn Sci. 2005 May;9(5):242-9. Review.

ReferenceCitation: Peterson CK, Shackman AJ, Harmon-Jones E. The role of asymmetrical frontal cortical activity in aggression. Psychophysiology. 2008 Jan;45(1):86-92. Epub 2007 Sep 10.

ReferenceCitation: Phan KL, Taylor SF, Welsh RC, Decker LR, Noll DC, Nichols TE, Britton JC, Liberzon I. Activation of the medial prefrontal cortex and extended amygdala by individual ratings of emotional arousal: a fMRI study. Biol Psychiatry. 2003 Feb 1;53(3):211-5.

ReferenceCitation: Phillips ML, Drevets WC, Rauch SL, Lane R. Neurobiology of emotion perception I: The neural basis of normal emotion perception. Biol Psychiatry. 2003 Sep 1;54(5):504-14. Review.

ReferenceCitation: Phillips ML, Ladouceur CD, Drevets WC. A neural model of voluntary and automatic emotion regulation: implications for understanding the pathophysiology and neurodevelopment of bipolar disorder. Mol Psychiatry. 2008 Sep;13(9):829, 833-57. doi: 10.1038/mp.2008.65. Epub 2008 Jun 24. Review.

ReferenceCitation: Rich BA, Schmajuk M, Perez-Edgar KE, Pine DS, Fox NA, Leibenluft E. The impact of reward, punishment, and frustration on attention in pediatric bipolar disorder. Biol Psychiatry. 2005 Oct 1;58(7):532-9. Epub 2005 Jun 13.

ReferenceCitation: Sander D. et Scherer K.R. (2009). Traité de psychologie des émotions. Dunod édition.

ReferenceCitation: Savitz J, Drevets WC. Bipolar and major depressive disorder: neuroimaging the developmental-degenerative divide. Neurosci Biobehav Rev. 2009 May;33(5):699-771. doi: 10.1016/j.neubiorev.2009.01.004. Epub 2009 Jan 21. Review.

ReferenceCitation: Scherer, K.R. (2001). " Appraisal considered as a process of multilevel sequential checking ". In K.R. Scherer, A. Schorr, T. Johm-Stone (éd.), Appraisal Processes in Emotion: Theory, Methods, Research. New York: Oxforf University Press.

ReferenceCitation: Schiff BB, Guirguis M, Kenwood C, Herman CP. Asymmetrical hemispheric activation and behavioral persistence: effects of unilateral muscle contractions. Neuropsychology. 1998 Oct;12(4):526-32.

ReferenceCitation: Shenton ME, Dickey CC, Frumin M, McCarley RW. A review of MRI findings in schizophrenia. Schizophr Res. 2001 Apr 15;49(1-2):1-52. Review.

ReferenceCitation: Taylor JG. A neural model of the loss of self in schizophrenia. Schizophr Bull. 2011 Nov;37(6):1229-47. doi: 10.1093/schbul/sbq033. Epub 2010 Apr 23. Review.

ReferenceCitation: Vita A, De Peri L, Silenzi C, Dieci M. Brain morphology in first-episode schizophrenia: a meta-analysis of quantitative magnetic resonance imaging studies. Schizophr Res. 2006 Feb 15;82(1):75-88. Epub 2005 Dec 27.

ReferenceCitation: Vuilleumier P, Armony JL, Driver J, Dolan RJ. Distinct spatial frequency sensitivities for processing faces and emotional expressions. Nat Neurosci. 2003 Jun;6(6):624-31.

ReferenceCitation: Wright IC, Rabe-Hesketh S, Woodruff PW, David AS, Murray RM, Bullmore ET. Meta-analysis of regional brain volumes in schizophrenia. Am J Psychiatry. 2000 Jan;157(1):16-25.

ipd_sharing: Undecided


title: Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer (FLUO-BREAST)

summary: This is a single-center prospective study evaluating the diagnostic performance and safety of Infracyanine in women with early breast cancer whose the research of sentinel node(s) combines isotopes and Infracyanine.

status: Completed

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Ngô C, Sharifzadehgan S, Lecurieux-Lafayette C, Belhouari H, Rousseau D, Bonsang-Kitzis H, Crouillebois L, Balaya V, Oudard S, Lécuru F, Elaidi RT. Indocyanine green for sentinel lymph node detection in early breast cancer: Prospective evaluation of detection rate and toxicity-The FLUOBREAST trial. Breast J. 2020 Dec;26(12):2357-2363. doi: 10.1111/tbj.14100. Epub 2020 Oct 22.

name: Hôpital Privé des Peupliers Ramsay Santé  Paris France

family: Ngô

full_name: Charlotte Ngô

given: Charlotte

name: Service de chirurgie cancérologique gynécologique et du sein Hôpital Européen Georges Pompidou AP‐HP  Paris France

family: Sharifzadehgan

full_name: Shervine Sharifzadehgan

given: Shervine

family: Lecurieux‐Lafayette

full_name: Cynthia Lecurieux‐Lafayette

given: Cynthia

name: ARTIC Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie  Paris France

family: Belhouari

full_name: Houda Belhouari

given: Houda

name: Département de pharmacie Hôpital Européen Georges Pompidou AP‐HP  Paris France

family: Rousseau

full_name: Dominique Rousseau

given: Dominique

family: Bonsang‐Kitzis

full_name: Hélène Bonsang‐Kitzis

given: Hélène

family: Crouillebois

full_name: Laurence Crouillebois

given: Laurence

name: Service de Gynécologie‐obstétrique et chirurgie gynécologique et mammaire Centre hospitalier Universitaire Vaudois  Lausanne Switzerland

family: Balaya

full_name: Vincent Balaya

given: Vincent

name: Faculty of Medicine Paris Descartes University  Paris France

name: Service d’oncologie médicale Hôpital Européen Georges Pompidou AP‐HP  Paris France

family: Oudard

full_name: Stéphane Oudard

given: Stéphane

name: Département de chirurgie oncologique Institut Curie  Paris France

family: Lécuru

full_name: Fabrice Lécuru

given: Fabrice

family: Elaidi

full_name: Reza‐Thierry Elaidi

given: Reza‐Thierry

journal_name: The Breast Journal

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Indocyanine green for sentinel lymph node detection in early breast cancer: Prospective evaluation of detection rate and toxicity—The FLUOBREAST trial

ipd_sharing: No

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Measurement of Maximum Diameter of Native Abdominal Aortic Aneurysm by Angio-computed Tomography

acronym: AAA-angioCT

summary:
Screening for an abdominal aortic aneurysm, monitoring its growth and evaluation of its risk of rupture are based on the measure of its maximum diameter. The abdominal aortic aneurysm's treatment to prevent its rupture is recommended from a threshold of 50-55 mm in men and of 45-50 mm in women.

The importance of this measure for patient management justify a specific and homogeneous protocol of measure. However, the diversity of methods of measuring the maximum diameter with scanner and ultrasound was shown.

The impact of various angio-CT based measures of maximum AAA diameter, and the impact of reproducibility limits on the decision to operate have never been investigated.

time_perspective: Retrospective

lead_sponsor: CHU de Reims


title: Comparative Study of Anterior Tibial Translation Measurement by Four Different Laximeters in Anterior Cruciate Ligament Ruptures

acronym: LAXIMETRIE

summary: Actually, there are several laximeters for measuring anterior tibial translational in case of anterior cruciate ligament rupture. The most commonly used are telos, KT-1000, GnrB and Rolimeter. Results of these instrumented tests, which expressed in differential (millimeters values), have a bad correlation between them and so are not comparable in current literature. The aim of this study was to compare results of these tests and establish a ratio (pathologic knee laxity/ healthy knee laxity) to reduce differences between each instrumented test.

lead_sponsor: Versailles Hospital

intervention_type: Procedure


title: Assessment of Global Longitudinal Strain at Low Dose Anthracycline-based Chemotherapy for the Prediction of Subsequent Cardiotoxicity

acronym: Anthracardio

summary:
Anthracycline therapy is well-known for its adverse cardiac effects. Anthracycline-induced cardiotoxicity (AIC) is associated with a poor prognosis; since classical heart failure treatment can potentially reverse cardiac dysfunction at the early stage of cardiac toxicity, early detection of AIC is crucial.

Transthoracic echocardiography is recommended for monitoring left ventricular function in patients receiving these molecules. In routine practice, left ventricular systolic function is mainly assessed by the left ventricular ejection fraction (LVEF), measured by two-dimensional echocardiography imaging. However, LVEF depends on the operator's experience and is not sensitive enough to detect subclinical myocardial dysfunction.

To overcome these limitations, two-dimensional speckle-tracking imaging has been proposed. This technique allows for a study of global and regional myocardial deformation, especially the longitudinal component, which appears to be the most sensitive one. Several studies have already emphasized the role of global longitudinal strain (GLS) to detect slight alterations in systolic function, especially in the setting of potentially cardiotoxic drugs and even after low to moderate doses of anthracyclines. A recent expert consensus paper strongly recommends GLS assessment for the detection of subclinical left ventricular dysfunction due to anthracycline therapy.

Although there is growing evidence that GLS can predict subsequent alterations in LVEF, few data exist on the optimal timing to perform echocardiography.

The investigators hypothesized that very early measurement of GLS in the time course of anthracycline therapy could predict subsequent left ventricular systolic dysfunction.

The aim of this study was, therefore, to determine whether assessment of GLS after 150 mg/m² of anthracyclines can predict AIC.


title: Impact of Cataract Surgery on Keratoplasty Graft Survival

acronym: IGREC

summary:
The follow up time after keratoplasty now routinely exceeds multiple decades. It is common for keratoplasty patients to also undergo cataract surgery at a later date in their lives.

Keratoplasties and cataract surgery both result in local inflammation. This may influence the density of endothelial cells, and on average there is a loss of 10% in endothelial cells within 3 months of the cataract surgery. Yet, a sufficient density of endothelial cells is required to maintain graft transparency. It may be therefore difficult to strike a balance between loss of visual acuity due to the cataract of to the loss of graft transparency over the long term.

The investigators aim to compare graft survival in patients with clear crystalline lens with and without cataract surgery.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


type: Other Identifier

title: Evaluation of the Functional Remission Occurrence and Predictive Factors in Schizophrenia

summary: In a population of patients suffering from schizophrenia being treated for an episode of clinical destabilization and followed for a period of twelve months, the main objective is to evaluate the proportion of patients achieving functional remission and its relationship to clinical remission.

lead_sponsor: Janssen-Cilag Ltd.


title: Evaluation of the Water Drinking Test Response in Supine and Sitting Position Using the Continuous Intraocular Pressure Measurement Device Sensimed Triggerfish in Healthy Subjects

acronym: PIO-WDT

summary: Monocentric, prospective study, comparison of the water drinking test response in the supine and in the sitting position using the intraocular pressure monitoring device Sensimed Triggerfish in healthy subjects.

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intervention_type: Device


title: Validation of a Portable Medical Device for Diagnostic in Vitro, Designed to Measure Blood Coagulation's Biological Parameters

acronym: HEMOPTIC

summary:
This clinical trial is about a new technology, named HEMOPTIC. It enables to mesure time of blood coagulation for monitoring of patients under Vitamin K antagonist (VKA).

This device was created as an alternative to blood sample, that have to be done in a medical laboratory.

The main goal is to evaluate the accuracy of the International Normalized Ratio (INR) measurement of this new portable device for diagnostic in vitro, among healthy patients and patients under anti-vitamin K treatment.

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ReferenceCitation: Faivre M, Peltié P, Planat-Chrétien A, Cosnier ML, Cubizolles M, Nougier C, Négrier C, Pouteau P. Coagulation dynamics of a blood sample by multiple scattering analysis. J Biomed Opt. 2011 May;16(5):057001. doi: 10.1117/1.3573813.

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ReferenceCitation: Riberolles, C. (2009). Résultats du PHRC autocontôle de l'anticoagulation. Conférence. XIXes Journées européennes de la Société française de cardiologie, Paris.


title: Characterization of Independant Task Neural Correlates of Different Levels of Mental Workload

acronym: CARACOg

summary:
The goal is to identify neuro-physiological signatures at several levels of mental workload during the realisation of tasks, performed by all the subjects.

In parallel, there will be a methodological work consisting to develop the classification algorithms, predictives of these levels of mental workload in real time, in purpose to implement a passive brain-machine interface in the best interest of operators that accomplish complex tasks.

Mesures of electro-physiological activity will be recorded in order to approve states of charge in addition to behavioral performances.

primary_purpose: Basic Science

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title: Evaluation of Pupillary Distension Reflexes, as a Tool for the Monitoring of Analgesia for Patients in Intensive Care.

acronym: PUPILLO REA

summary:
Sedation-analgesia is an important therapy for patients in resuscitation. It requires a surveillance, in order to avoid excessive or insufficient dosages of sedative or nonmorphinics, sources of side effects. Yet, means of surveillance are limited in resuscitation care : variations of blood pressure and heart rate are not very sensitive criterias. Clinical scales to measure the sedation and analgesia level were proposed for patients in resuscitation, including the Richmond (RASS) sedation scale and the behavioural pain scale (BPS). The study of pupillary dilatation's reflex (RDP) due to a nociceptive stimulation is a tool proposed for the monitoring of the analgesia peroperative for patients under general anaesthetic. Yet, there isn't any study that measured the analgesia threshold by pupillometry for patients in resuscitation receiving a sedation-analgesia.

The main goal of this study is to measure the minimum intensity of a painful stimulation (tetanus), leading to a 10% raise of RDP in a cohort of patients in resuscitation care receiving sedation-analgesia continuously.

ReferenceCitation: Sauder P, Andreoletti M, Cambonie G, Capellier G, Feissel M, Gall O, Goldran-Toledano D, Kierzek G, Mateo J, Mentec H, Mion G, Rigaud JP, Seguin P. [Sedation and analgesia in intensive care (with the exception of new-born babies). French Society of Anesthesia and Resuscitation. French-speaking Resuscitation Society]. Ann Fr Anesth Reanim. 2008 Jul-Aug;27(7-8):541-51. doi: 10.1016/j.annfar.2008.04.021. Epub 2008 Jun 24. French.

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ReferenceCitation: The management of the agitated ICU patient. Crit Care Med. 2002 Jan;30(1 Suppl Management):S97-123; quiz S124-25.

ReferenceCitation: Kollef MH, Levy NT, Ahrens TS, Schaiff R, Prentice D, Sherman G. The use of continuous i.v. sedation is associated with prolongation of mechanical ventilation. Chest. 1998 Aug;114(2):541-8.

ReferenceCitation: Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44.

ReferenceCitation: Chanques G, Jaber S, Barbotte E, Verdier R, Henriette K, Lefrant JY, Eledjam JJ. [Validation of the french translated Richmond vigilance-agitation scale]. Ann Fr Anesth Reanim. 2006 Jul;25(7):696-701. Epub 2006 May 15. French.

ReferenceCitation: Puntillo KA, Morris AB, Thompson CL, Stanik-Hutt J, White CA, Wild LR. Pain behaviors observed during six common procedures: results from Thunder Project II. Crit Care Med. 2004 Feb;32(2):421-7.

ReferenceCitation: Payen JF, Bru O, Bosson JL, Lagrasta A, Novel E, Deschaux I, Lavagne P, Jacquot C. Assessing pain in critically ill sedated patients by using a behavioral pain scale. Crit Care Med. 2001 Dec;29(12):2258-63.

ReferenceCitation: Yang LL, Niemann CU, Larson MD. Mechanism of pupillary reflex dilation in awake volunteers and in organ donors. Anesthesiology. 2003 Dec;99(6):1281-6.

ReferenceCitation: Barvais L, Engelman E, Eba JM, Coussaert E, Cantraine F, Kenny GN. Effect site concentrations of remifentanil and pupil response to noxious stimulation. Br J Anaesth. 2003 Sep;91(3):347-52.

ReferenceCitation: Constant I, Nghe MC, Boudet L, Berniere J, Schrayer S, Seeman R, Murat I. Reflex pupillary dilatation in response to skin incision and alfentanil in children anaesthetized with sevoflurane: a more sensitive measure of noxious stimulation than the commonly used variables. Br J Anaesth. 2006 May;96(5):614-9. Epub 2006 Mar 24.

ReferenceCitation: Larson MD, Sessler DI, Washington DE, Merrifield BR, Hynson JA, McGuire J. Pupillary response to noxious stimulation during isoflurane and propofol anesthesia. Anesth Analg. 1993 May;76(5):1072-8.

ReferenceCitation: Jeanne M, Joulin O. [The 18th meeting of the Société Francophone d'Informatique et de Monitorage en Anesthésie-Réanimation (Sfimar)]. Ann Fr Anesth Reanim. 2011 Oct;30(10):770-1. doi: 10.1016/j.annfar.2011.08.007. Epub 2011 Sep 23. French.

ReferenceCitation: Larson MD, Talke PO. Effect of dexmedetomidine, an alpha2-adrenoceptor agonist, on human pupillary reflexes during general anaesthesia. Br J Clin Pharmacol. 2001 Jan;51(1):27-33.

ReferenceCitation: Li D, Miaskowski C, Burkhardt D, Puntillo K. Evaluations of physiologic reactivity and reflexive behaviors during noxious procedures in sedated critically ill patients. J Crit Care. 2009 Sep;24(3):472.e9-13. doi: 10.1016/j.jcrc.2008.07.005. Epub 2009 Jan 17.


title: Genetic Susceptibility and Influence of the Microbiomae in Bullous Pemphigoid

acronym: MICROPB

summary:
Autoimmune bullous dermatoses include pemphigus, bullous pemphigoid, pemphigoid gestationis, linear IgA dermatosis, mucous membrane pemphigoid, lichen planus pemphigoid, anti-p200 pemphigoid, epidermolysis bullosa acquisita and dermatitis herpetiformis. Autoimmune bullous dermatoses are rare and have an incidence of 20-60 new cases per 1 million person- year in Europe. The incidence of the individual entities is slight significantly different within Europe, but strongly also in comparison to other countries such as Kuwait, Singapore, USA and South America. The most common of these disorders is the bullous pemphigoid.

A considerable progress has been made in the last years to elucidate the pathogenic role of autoantibodies in these diseases. To this end, various in vitro and animal experiments have been used to understand some basic pathophysiological mechanisms in these diseases. Further studies are currently being carried out to explain a precise elucidation of the disease process and to be able to treat the patients targeted later.

At present, however, no data are available to explain why certain individuals develop the autoimmune disease and others do not. Epidemiological studies showed some triggers to the development of autoimmune dysregulation, e.g. drugs.

Furthermore, it has been shown that genetic factors play a role in the pathogenesis of the disease. A clear association with certain HLA regions have been shown in patients with pemphigus, e.g. about 95% of pemphigus patients from the group of Ashkenazi Jews have the HLA-DRB1*0402 haplotype. Recently, the first non-HLA gene associated with pemphigus was described. For other conditions such as bullous pemphigoid, pemphigoid gestationis or linear IgA dermatosis the association with HLA antigens is less pronounced. Another indication of the importance of the genetic background in these diseases can be elucidated from the observation of autoantibodies at a low concentration in healthy relatives of pemphigus patients.

design_allocation: Non-Randomized


title: Polyclonal Antilymphocyte Globulin (ATG) & Intestinal Immune Barrier After Kidney Transplantation

acronym: GABII

summary:
The prevention of allograft rejection in kidney transplantation requires administering to the patient an immunosuppressive regimen of induction. The induction strategy is based on an injection of polyclonal anti-lymphocyte globulin (ATG-FLAG or fresenius®) driving a lymphocyte lysis, or an injection of monoclonal antibodies directed against non-lymphopenic the α chain of the IL-receptor 2 (anti-CD25 antibody, basiliximab), by immunological risk patients. Our group showed a significant increase in death rates in transplant patients with lymphopenia CD4 continued beyond 2 years of transplantation. This excess mortality is related to complications following chronic inflammation observed in some patients lymphopenic.

Preliminary studies have shown that the induced lymphodéplétion ATG appears to be accompanied by an increase of the bacterial products in the blood of transplanted since a significant increase in the sCD14 is observed in these patients one year. We also observed increased concentrations of LPS in patients in the ATG group. This could indicate a secondary bacterial intestinal translocation to a weakening of intestinal immunity linked to the ATG.

The main objective of the study is to assess the impact of anti-lymphocyte globulin polyclonal on intestinal permeability, estimated by the rate lipopolysaccharide (LPS, a constituent of the cell wall of Gram-negative bacteria) blood after kidney transplantation.

The secondary objectives are to evaluate bacterial translocation, the effect of bacterial translocation on structural and metabolic functions of the intestinal epithelium, chronic inflammation, immune reconstitution, regeneration, activation and proliferation of T lymphocytes, the polymorphism of the LPS receptor that causes the activation of innate immunity and the composition of the intestinal microbiota.

The study population consists of renal transplant patients of Nephrology of the University Hospital of Besancon. Patients will be divided into 2 groups according to induction immunosuppressive therapy prescribed the day of renal transplantation as part of their usual care, ie treatment with anti-lymphocyte globulin polyclonal (ATG-Fresenius®) or antibody treatment monoclonal anti-CD25 (basiliximab Simulect). The patient group treated with anti-CD25 antibody will serve as a control group (no depletion of the immune system) to the group of patients treated with ATG.

primary_purpose: Treatment


title: Acceptability of Products and Eating Pleasure in Elderly People Living at Home or in an EHPAD

acronym: OPTIFEL

summary:
In independent elderly people, the aim is to test recipes for different types of food from different countries (starter, main course with culinary aids, carrot purees, desserts and smoothies) likely to improve sensory acceptability of foods for elderly people who are dependent for their meals (persons for whom at least one meal per day is provided by a catering service - meals at home, old people's home). All of the recipes were developed thanks to the first two parts of the OPTIFEL project so as to take into account the needs of elderly people and recommendations in each country. The interest is to increase the sapidity/ attractiveness of meals by optimizing sensory properties and the nutritional content of the foods, to meet the nutritional needs of this specific population with enriched recipes (with leguminous proteins and/or vitamins and minerals and/or fibre) suitable for different cultures. This ongoing research is being conducted on 2-4 different variants of each type of product: the starter (a soup of legumes), the main dish (diced chicken with culinary aids) and garnished (carrot puree), an apple-based dessert and fruit smoothies.

For each product family, two products will be selected for each country: the preferred product (highest hedonic value of recipes enriched with leguminous proteins and/or vitamins and minerals) and the standard product without enrichment.

Finally, at the end of this study, nine products will have been chosen: 2 soups, 2 culinary aids, 2 carrot purees, 2 desserts and 1 smoothie

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Dietary Supplement


title: Study of Specific CD4 Tumors Th1 Responses in Renal Transplant After Occurrence of Cancer

acronym: TRAK

summary:
As early complications of transplantation (acute rejection and infections) were better controlled and that the survival of kidney transplants has increased, chronic complications of immunosuppression became increasing challenges. The incidence of cancer is greatly increased in transplant and cancer is now the first cause of death. The iatrogenic immunosuppression plays a major role in the increased incidence of cancer. If it is accepted that the incidence of cancer is generally increased after transplantation, the increased risk is very different from a specific cancer to another. Furthermore the specific treatment of the tumor (surgery, radiotherapy, chemotherapy, biotherapy), the specificity of the context of transplantation is related to the possibility of modulation of immunosuppression. However, there is no immunological marker for predicting the effectiveness of a modification of the immunosuppression.

Several studies point to the important role of CD4 T cells into Th1 anti-tumor immunosurveillance group cancers. Identified "helper" degenerate peptides, called Universal Cancer Peptide (UCP) derivative of telomerase, a type of tumor antigen universal. These UCP peptides bind most HLA-DR alleles most frequent of the population and have the particularity of specifically stimulate CD4 T cells of type Th1. Using a test based on the UCP, it possible to detect the presence of spontaneous CD4 Th1 anti-UCP answers in several types of human cancers.

The main objective of this study is to determine whether, in renal transplant patients, the occurrence of cancer is associated with a deficiency of CD4 Th1 response anti-hTERT.

status: Recruiting

primary_purpose: Screening

status_simplified: Ongoing


title: Molecular Analysis of 150 Lung Adenocarcinoma With Corresponding Histopathological and Clinical Data Available

acronym: LUNG-EST

summary:
LUNG-EST is a retrospective study including 152 patients who benefit from lung surgery during the years 2012 to 2013 at Hospices civils de Lyon and with a diagnosis of lung adenocarcinomas. For all patients, clinical data and histopathological data are available. The objective of this study is to characterize these lung adenocarcinomas by the LungCarta Panel using the mass spectrometry array Sequenom. This panel could identify 214 DNA mutations and/or frameshift insert/deletion among 26 oncogenes. Once included in the study, the adenocarcinomas are also included in a Tissue MicroArray (TMA) in order to perform immunohistochemical analysis. Immunohistochemical staining with innovative antibodies are correlated with clinical, histopathological and molecular data.

Our hypothesis is that this TMA could constitute a good tool to screen interesting protein's expression.

lead_sponsor: Hospices Civils de Lyon

location_facility: Anatomie et cytologie pathologiques Groupement hospitalier Est, Institut de cancérologie des Hospices civils de Lyon,

intervention_type: Genetic


title: Efficacy of Heat-shock Protein (HSP) Inhibitors in Myeloproliferative Syndromes (MPS): Fundamental Observational in Vitro Study Using Samples From a Collection

acronym: HSP-SMP

summary:
Heat-shock proteins (HSP) have been very highly conserved throughout the evolution of species and are characterized by their chaperone function, thanks to their ability to prevent aggregation and to promote the renaturation/break down of damaged proteins. Among other targets, they also chaperone JAK2, a key step that is deregulated in signalling in myeloproliferative syndromes (MPS) because of the JAK2V617F mutation. These HSP also have a potent cytoprotective action through their multiples inhibiting effects on apoptotic processes.

Little is known about levels of HSP expression, in particular for HSP70 and HSP27, in MPS cells.

However, in vitro studies of different cell models have shown the interest of HSP90 inhibitors in slowing cell proliferation in MPS. These results have been confirmed in animal models with results in terms of blood counts and overall survival. In addition, it seems that the V617F mutated form of JAK2 is more sensitive than the wild-type to HSP90 inhibitors. Finally, inhibitors of HSP90 remain efficacious with regard to the inhibition of cell growth, even in cases of resistance to JAK2 inhibitors. Nonetheless, HSP90 inhibitors are known to stimulate the expression of other HSP, notably HSP27 and HSP70, which are, through their properties, tumorigenic and could lead to an escape phenomenon. Thus the combined use of several HSP inhibitors could be beneficial, and eventually present synergistic effects on the inhibition of tumour processes.


title: Evaluation of Biological Biomarkers Diagnostic of Toxoplasmosis Uveitis

acronym: BIOLUVE

summary:
Toxoplasmosis affects one to two newborn each 10000 births. Among them, 1 to 2 % develop learning disabilities or die, and 4 to 27 % develop a chorioretinitis sometimes leading to an amblyopia responsible for visual impairment. Toxoplasmosis uveitis affects too adults immunocompetent and immunodepressed who have had an acquired toxoplasmosis. Clinical diagnosis of ocular toxoplasmosis is more complicated in presence of posterior neuro-retinitis, inflammation of the papilla, uveitis without chorioretinitis, fuchs heterochromic iridocyclitis, scleritis, diffuse necrotizing or multifocal retinitis. In this situation biological markers diagnostic and prognostic of toxoplasmosis uveitis are useful.

Highly kept molecules (during evolution) like stress proteins (Hsp) are are found in the host and the pathogen and there can trigger a crossed immune response. Stress proteins haven't been explored yet, in the context of toxoplasmosis uveitis on humans.

The hypothesis is that Hsp70 and antibodies anti-Hsp70 are diagnostic and prognostic markers of ocular toxoplasmosis.

The goal is to evaluate diagnosis value of biological markers (Hsp70 and antibodies IgG anti-Hsp70) in toxoplasmosis uveitis.

ReferenceCitation: Bonfioli AA, Orefice F. Toxoplasmosis. Semin Ophthalmol. 2005 Jul-Sep;20(3):129-41. Review.

ReferenceCitation: Bouillet L, Sarrot-Reynauld F, Gonzalvez B, Massot C, Romanet J, Mouillon M. [Diagnostic strategy in uveitis: a prospective study in 125 cases]. J Fr Ophtalmol. 2000 Jun;23(6):569-75. French.

ReferenceCitation: Brenier-Pinchart MP, Morand-Bui V, Fricker-Hidalgo H, Equy V, Marlu R, Pelloux H. Adapting a conventional PCR assay for Toxoplasma gondii detection to real-time quantitative PCR including a competitive internal control. Parasite. 2007 Jun;14(2):149-54.

ReferenceCitation: Chen M, Aosai F, Norose K, Mun HS, Yano A. The role of anti-HSP70 autoantibody-forming V(H)1-J(H)1 B-1 cells in Toxoplasma gondii-infected mice. Int Immunol. 2003 Jan;15(1):39-47.

ReferenceCitation: Chumpitazi BF, Boussaid A, Pelloux H, Racinet C, Bost M, Goullier-Fleuret A. Diagnosis of congenital toxoplasmosis by immunoblotting and relationship with other methods. J Clin Microbiol. 1995 Jun;33(6):1479-85.

ReferenceCitation: Chumpitazi BF, Bouillet L, Drouet MT, Kuhn L, Garin J, Zarski JP, Drouet C. Biological autoimmunity screening in hepatitis C patients by anti-HepG2 lysate and anti-heat shock protein 70.1 autoantibodies. Eur J Clin Microbiol Infect Dis. 2009 Feb;28(2):137-46. doi: 10.1007/s10096-008-0599-y. Epub 2008 Aug 12.

ReferenceCitation: Delair E, Monnet D, Grabar S, Dupouy-Camet J, Yera H, Brézin AP. Respective roles of acquired and congenital infections in presumed ocular toxoplasmosis. Am J Ophthalmol. 2008 Dec;146(6):851-5. doi: 10.1016/j.ajo.2008.06.027. Epub 2008 Aug 23.

ReferenceCitation: Derouin F, Bultel C, Roze S. (Coordination rédactionnelle). Toxoplasmose: état des connaissances et évaluation du risque lié à l'alimentation. Rapport du groupe de travail " Toxoplasma gondii " de l'Afssa. Coordination éditoriale : Thomann C & Ribeiro F. AFSSA Déc. 2005, pp318.

ReferenceCitation: Desmonts G. Definitive serological diagnosis of ocular toxoplasmosis. Arch Ophthalmol. 1966 Dec;76(6):839-51.

ReferenceCitation: Direskeneli H, Saruhan-Direskeneli G. The role of heat shock proteins in Behçet's disease. Clin Exp Rheumatol. 2003 Jul-Aug;21(4 Suppl 30):S44-8. Review.

ReferenceCitation: Echeverria PC, Matrajt M, Harb OS, Zappia MP, Costas MA, Roos DS, Dubremetz JF, Angel SO. Toxoplasma gondii Hsp90 is a potential drug target whose expression and subcellular localization are developmentally regulated. J Mol Biol. 2005 Jul 22;350(4):723-34.

ReferenceCitation: Fang H, Aosai F, Mun HS, Norose K, Ahmed AK, Furuya M, Yano A. Anaphylactic reaction induced by Toxoplasma gondii-derived heat shock protein 70. Int Immunol. 2006 Oct;18(10):1487-97. Epub 2006 Aug 30.

ReferenceCitation: Holland GN. Reconsidering the pathogenesis of ocular toxoplasmosis. Am J Ophthalmol. 1999 Oct;128(4):502-5. Review.

ReferenceCitation: Imamura Y, Kurokawa MS, Yoshikawa H, Nara K, Takada E, Masuda C, Tsukikawa S, Ozaki S, Matsuda T, Suzuki N. Involvement of Th1 cells and heat shock protein 60 in the pathogenesis of intestinal Behcet's disease. Clin Exp Immunol. 2005 Feb;139(2):371-8.

ReferenceCitation: Kodjikian L, Wallon M, Fleury J, Denis P, Binquet C, Peyron F, Garweg JG. Ocular manifestations in congenital toxoplasmosis. Graefes Arch Clin Exp Ophthalmol. 2006 Jan;244(1):14-21. Epub 2005 May 20.

ReferenceCitation: Lyons RE, Johnson AM. Heat shock proteins of Toxoplasma gondii. Parasite Immunol. 1995 Jul;17(7):353-9.

ReferenceCitation: Maubon D, Ajzenberg D, Brenier-Pinchart MP, Dardé ML, Pelloux H. What are the respective host and parasite contributions to toxoplasmosis? Trends Parasitol. 2008 Jul;24(7):299-303. doi: 10.1016/j.pt.2008.03.012. Epub 2008 May 29.

ReferenceCitation: Pelloux H, Mouillon M, Romanet JP, Reynier P, Ligeon P, Goullier-Fleuret A, Ambroise-Thomas P. [Ocular toxoplasmosis. Comparison between two biological methods to study aqueous humor]. Presse Med. 1991 Oct 26;20(34):1655-8. French.

ReferenceCitation: Quintana FJ, Cohen IR. Heat shock proteins as endogenous adjuvants in sterile and septic inflammation. J Immunol. 2005 Sep 1;175(5):2777-82. Review.

ReferenceCitation: SenGupta D, Norris PJ, Suscovich TJ, Hassan-Zahraee M, Moffett HF, Trocha A, Draenert R, Goulder PJ, Binder RJ, Levey DL, Walker BD, Srivastava PK, Brander C. Heat shock protein-mediated cross-presentation of exogenous HIV antigen on HLA class I and class II. J Immunol. 2004 Aug 1;173(3):1987-93.

ReferenceCitation: Silva NM, Gazzinelli RT, Silva DA, Ferro EA, Kasper LH, Mineo JR. Expression of Toxoplasma gondii-specific heat shock protein 70 during In vivo conversion of bradyzoites to tachyzoites. Infect Immun. 1998 Aug;66(8):3959-63.

ReferenceCitation: Wang XH, Qin Y, Hu MH, Xie Y. Dendritic cells pulsed with gp96-peptide complexes derived from human hepatocellular carcinoma (HCC) induce specific cytotoxic T lymphocytes. Cancer Immunol Immunother. 2005 Oct;54(10):971-80. Epub 2005 Jun 18.


title: Catalytic Antibodies to Predict Uninvasively Late Transplant Failure

acronym: CATAPULT

summary: Chronic Allograft Nephropathy (CAN), a major cause of late allograft failure, is characterized by a progressive decline in graft function correlating with tissue destruction. Recent data suggest that it may be possible to delay graft destruction if adequate management is initiated early (ie, at the stage of subclinical CAN). It is therefore essential to design new tests allowing physicians to predict transplant recipients prone to develop CAN


title: Weaning From Mechanical Ventilation Comparison of Open-loop Decision Support System and Routine Care

acronym: BEACON

summary: The purpose of this study is to compare mechanical ventilation following advice from the Beacon Caresystem to that of routine care in patients from the state of requiring invasive mechanical ventilation until successful extubation. The Beacon Caresystem will be compared to routine care to investigate whether use of the system results in similar care and reduced time for weaning from mechanical ventilation.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Orthopedic Digital Planning for Total Hip Arthroplasties

acronym: ORTHOPLAN

summary:
Preoperative planning has been carried out to allow for response preparedness . A layer technique is usually used with standard radiography .The investigators have a record of routine preoperative radiographs by standard recognized as having an advantage over the reproducibility of measurements compared with plain radiography . The Toulouse Hospitals have developed this technology and is part of the routine assessment of hip prothesis pre and postoperatively.

The TraumaCad software can superimpose implants on Picture Archiving and Communication System and evaluate digital and reproducible size of the implants and their correct position .

This is to demonstrate the superiority of modern digital tools in the preoperative preparation in Orthopaedics set.

lead_sponsor: University Hospital, Toulouse


title: Impedance Cardiography by PhysioFlow® for Non-invasive Cardiac Output Monitoring: a Comparison With Trans-thoracic Echocardiography in Pediatric Intensive Care Patients.

acronym: PF-ECHO

summary: PhysioFlow® (PF®) is a new cardiac output (CO) monitoring method by impedance cardiography (IC), never studied in pediatric intensive care unit (PICU). The aim of the study was to compare CO and cardiac index (CI) measurements (IC) by trans-thoracic Doppler echocardiography (TTE) (COTTE and CITTE) and PF® (COIC and CIIC) in PICU.

lead_sponsor: University Hospital, Lille


title: Evaluation of the Potential Association Between 5α-reductase Inhibitors Prescription and Occurrence of High Grade Prostate Cancers

acronym: CANARI

summary: This is a multicenter, cohort study based on medico-administrative data from pathology laboratory registries and drug reimbursement files (CNAM-TS).

lead_sponsor: Rennes University Hospital


title: Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Patients Carriers of Leg Ulcers

acronym: MecaSkin

summary: This study deals with the feasibility of an ATMP (Advanced Therapy Medicinal Product) production for the treatment of chronic wounds ulcer. Recruitment concerns patients (n=7) with leg ulcers and receiving a skin pellet graft. During surgical procedure, supernumerary biopsies are planned to be done in order to be transferred to laboratory. Then, the possibility of cell extraction (keratinocytes and fibroblasts), expansion, banking and use for skin substitute production in clinical condition is evaluated (primary outcome).

ipd_sharing: Yes


title: Etude de Cohorte évaluant l'Impact de l'Association chimiothérapie et Bevacizumab en 1ère Ligne du Cancer Colorectal métastatique Sur la qualité de Vie Relative Des Patients. Etude COBEQOL

acronym: COBEQOL

summary: The primary aim of this french multicenter national study is to assess and compare time to quality of life score deterioration (targeted dimensions : global health, fatigue and emotional functionning of EORTC QLQC30 according to the first line chemotherapy associated with bevacizumab in metastatic colorectal patients.


title: Diagnosis Accuracy of Noninvasive Screening by PCR Digital for Down Syndrom

summary:
The main objective of this study is to estimate the intrinsic diagnostic qualities of the digital dPCR in the screening of T21 from a multicentrique sample of patients with pregnancies at high risk of T21 (risk > 1/250).

The profit expected from this technique is to propose to the encircled women a screening more successful than that of the screening combined(organized) of the 1st quarter, simple of realization and in a moderate cost. We thus propose here an original alternative(alternate) method to the exclusive, expensive and binding techniques of top-debit(-flow). The recent technical improvements and his(her,its) advantages medical - economic allow to envisage a reliable, strong and long-lasting use of the dPCR in clinical routine in the DPNI of T21 in most of the laboratories. This pilot project could serve for the later development of a study of clinical validation multicentrique of large scale(big turntable ladder).

ReferenceCitation: Cans C, Amblard F, Devillard F, Pison H, Jalbert P, Jouk PS. Population screening for aneuploidy using maternal age and ultrasound. Prenat Diagn. 1998 Jul;18(7):683-92.

ReferenceType: result

ReferenceCitation: Coutton C, Abada F, Karaouzene T, Sanlaville D, Satre V, Lunardi J, Jouk PS, Arnoult C, Thierry-Mieg N, Ray PF. Fine characterisation of a recombination hotspot at the DPY19L2 locus and resolution of the paradoxical excess of duplications over deletions in the general population. PLoS Genet. 2013 Mar;9(3):e1003363. doi: 10.1371/journal.pgen.1003363. Epub 2013 Mar 21.

family: Coutton

full_name: Charles Coutton

given: Charles

family: Abada

full_name: Farid Abada

given: Farid

family: Karaouzene

full_name: Thomas Karaouzene

given: Thomas

family: Sanlaville

full_name: Damien Sanlaville

given: Damien

family: Satre

full_name: Véronique Satre

given: Véronique

family: Lunardi

full_name: Joël Lunardi

given: Joël

family: Jouk

full_name: Pierre-Simon Jouk

given: Pierre-Simon

family: Arnoult

full_name: Christophe Arnoult

given: Christophe

family: Thierry-Mieg

full_name: Nicolas Thierry-Mieg

given: Nicolas

family: Ray

full_name: Pierre F. Ray

given: Pierre F.

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: PLoS Genetics

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Fine Characterisation of a Recombination Hotspot at the DPY19L2 Locus and Resolution of the Paradoxical Excess of Duplications over Deletions in the General Population

ReferenceCitation: Nadeau G, Coutton C, Amblard F, Michalowicz G, Frasca S, Fertin A, Devillard F, Satre V, Usson Y, Jouk PS. Interphase fluorescent in situ hybridization detection of the 7q11.23 chromosomal inversion in a clinical laboratory: automated versus manual scoring. Clin Chem Lab Med. 2013 Apr;51(4):e41-4.

ReferenceCitation: Coutton C, Bidart M, Rendu J, Devillard F, Vieville G, Amblard F, Lopez G, Jouk PS, Satre V. 190-kb duplication in 1p36.11 including PIGV and ARID1A genes in a girl with intellectual disability and hexadactyly. Clin Genet. 2013 Dec;84(6):596-9. doi: 10.1111/cge.12113. Epub 2013 Mar 25.

name: Laboratoire de Génétique Chromosomique, Département de Génétique et Procréation; Hôpital Couple Enfant, CHU Grenoble; Grenoble France

name: Equipe “Génétique, Infertilité et Thérapeutique”; Laboratoire AGIM, CNRS FRE3405; Grenoble France

name: Université Joseph Fourier; Grenoble France

full_name: C Coutton

given: C

name: INSERM, U836, Team7 Nanomedicine and Brain, BP 170; Grenoble France

name: Biology and Pathology Institute; University Hospital Centre; Grenoble France

family: Bidart

full_name: M Bidart

given: M

name: Laboratoire de Biochimie et Génétique Moléculaire; CHU Grenoble; Grenoble France

family: Rendu

full_name: J Rendu

given: J

family: Devillard

full_name: F Devillard

given: F

family: Vieville

name: Service de Génétique Clinique, Département de Génétique et Procréation; Hôpital Couple Enfant, CHU Grenoble; Grenoble France

title: 190-kb duplication in 1p36.11 includingPIGVandARID1Agenes in a girl with intellectual disability and hexadactyly

ReferenceCitation: Ben Khelifa M, Coutton C, Zouari R, Karaouzène T, Rendu J, Bidart M, Yassine S, Pierre V, Delaroche J, Hennebicq S, Grunwald D, Escalier D, Pernet-Gallay K, Jouk PS, Thierry-Mieg N, Touré A, Arnoult C, Ray PF. Mutations in DNAH1, which encodes an inner arm heavy chain dynein, lead to male infertility from multiple morphological abnormalities of the sperm flagella. Am J Hum Genet. 2014 Jan 2;94(1):95-104. doi: 10.1016/j.ajhg.2013.11.017. Epub 2013 Dec 19.

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

title: Mutations in DNAH1, which Encodes an Inner Arm Heavy Chain Dynein, Lead to Male Infertility from Multiple Morphological Abnormalities of the Sperm Flagella


title: Evaluation and Modeling of the G-CSF Effect on the Evolution of Neutrophils During Chemotherapy Based on Eribulin

summary:
The anti-cancer cytotoxic chemotherapy is often the cause of neutropenia of grade IV or febrile neutropenia. Those neutropenia, in addition to being a comorbidity factor, result in dose reductions and/or temporary or permanent stop of chemotherapy, thus impacting clinical response. To avoid those episodes, or to shorten the duration and reduce the associated risk, administration of Granulocyte Colony Stimulating Factor (G-CSF) is recommended. Recombinant G-CSF reproduces the physiological effects of endogenous G-CSF by increasing the proliferation of granulocytes progenitors. Different forms of G-CSF are available: daily administration (such as filgrastim, lenograstim) and a single administration (pegfilgrastim).

Various international learned societies offer recommendations for primary care, secondary or curative neutropenia induced by chemotherapy based on G-CSF. However, guidance on the ideal time for the administration of growth factors and duration of administration are not very clear. If it seems clear that the treatment should not be initiated within the first 24 hours following administration of chemotherapy, summaries of the characteristics of different products do not provide evidence to optimize the administration day depending on the kinetics evolution of neutrophils. In addition, no information is given as to the choice of a formulation with respect to the other.

The pilot study the investigator propose aims to model the effect of exogenous G-CSF on the evolution of neutrophil function of time and explain the pharmacodynamic variability during the administration of chemotherapy based on eribulin. The description of the evolution of neutrophils when growth factors are administered give the opportunity to streamline administration regimens of these factors and to provide guidance on the circumstances in which they should or should not be given while weekly chemotherapy.

Expected benefits and foreseeable risks With the exception of surplus withdrawals during the first 2 cycles of treatment, this study will have no impact on the care of patients.

primary_purpose: Prevention

lead_sponsor: Centre Georges Francois Leclerc


title: Correlation Between Circulating Tumour Markers Early Variations and Clinical Response in First Line Treatment of Metastatic Colorectal Cancer

acronym: COCA-MACS

summary:
The chemotherapy monitoring is currently based on radiological (RECIST 1.1 guideline) and clinical evaluation every 3 months. Circulating markers as Carcino Embryonic Antigen (CEA), circulating tumour DNA and total cell free DNA represent an alternative approach to evaluate the response. In the field of metastatic colorectal cancer (mCRC) recent studies suggest that early evaluation could be clinically relevant. Indeed, early tumoral response seems to be correlated to overall survival. Moreover, post-operative morbidity increases with the number of prior chemotherapy treatments. Early evaluation could allow to modify chemotherapy regimens when response appears to be insufficient.

The aim of the present study is to evaluate, in a prospective cohort of patients treated with systemic IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy as first line treatment for a mCRC, the correlation between early variations of circulating tumour markers including CEA, circulating tumour DNA and total cell free DNA, and the 3 months objective response as defined in the RECIST 1.1 guideline.

lead_sponsor: University Hospital, Rouen


title: Enteric Nervous System in Alzheimer Disease

acronym: ENTEROMA

summary:
The close homology between the central and enteric nervous systems suggests that a disease process affecting the central nervous system could also involve its enteric counterpart. The investigators have recently shown in that the enteric neurons can be readily analyzed using routine colonic biopsies. This led us to propose that the enteric nervous system could represent a unique window to assess the neuropathology in living patients with a neurodegenerative disorder. The investigators have already used this approach to show that Parkinson's disease pathology was recapitulated in a single colonic biopsy. By contrast to Parkinson's disease, the detection of Alzheimer's disease (AD) pathology in the enteric neurons has so far failed. This may be due to the low number of human tissue samples in addition to the low sensitivity of the immunohistochemical methods that were used. The aim of the current research project will be therefore to reevaluate AD pathology in a large number of human colonic samples using both a morphological and biochemical approach .

The enteric nervous system could represent a unique window to assess the neuropathology in living patients with AD. This might open the way to the development of novel AD biomarkers that will directly assess the neuropathological process.

Main Aim : To Analyze the presence of beta-amyloid pathology in the enteric nervous system (ENS) in AD patients

Secondary Aim(s):

To analyze and describe the presence of tau in the enteric nervous system (ENS) in AD patients
To assess neuronal loss in submucosal tissue in AD patients.
To examine Glia cells in the enteric nervous system in AD patients..

lead_sponsor: Nantes University Hospital


title: Genetic Susceptibility Factors Involved in Candidemia: Case-control Study.

summary: This is a prospective case-control physiopathological study, which main objective is to determine the genetic host factors predisposing to candidemia. Secondary objectives are to develop new diagnosis tools using the biological collection, to describe and update epidemiology, to analyse the influence of genetic polymorphisms on prognosis.

location_facility: Hôpital Salengro, Intensive care departement, CHRU


title: Postoperative Cognitive Dysfunction After Intravenous Anesthesia or Closed-loop Coadministration of Propofol and Remifentanil Guided by Bispectral Index for Noncardiac Surgery : a Randomized Monocenter Study

acronym: POCD ELA

summary:
Background: Postoperative cognitive dysfunction (POCD) in elderly patients after noncardiac surgery is a common problem.

Therefore,this study was designed to assess POCD after closed-loop coadministration of propofol and remifentanil guided by bispectral index in comparison to intravenous anesthesia in elderly patients undergoing major noncardiac surgery. Methods: After approval of the local ethical committee was obtained, 204 patients (American Society of Anesthesiologists physical status I-III; age, > 55 yr) undergoing surgery (duration, > 1 h) were enrolled into this pospective randomized monocenter study. Patients received anesthesia 3 days after using a neuropsychological test battery.

ReferenceCitation: Besch G, Vettoretti L, Claveau M, Boichut N, Mahr N, Bouhake Y, Liu N, Chazot T, Samain E, Pili-Floury S. Early post-operative cognitive dysfunction after closed-loop versus manual target controlled-infusion of propofol and remifentanil in patients undergoing elective major non-cardiac surgery: Protocol of the randomized controlled single-blind POCD-ELA trial. Medicine (Baltimore). 2018 Oct;97(40):e12558. doi: 10.1097/MD.0000000000012558.

family: Besch

full_name: Guillaume Besch

given: Guillaume

family: Vettoretti

full_name: Lucie Vettoretti

given: Lucie

family: Claveau

full_name: Melanie Claveau

given: Melanie

family: Boichut

full_name: Nathalie Boichut

given: Nathalie

family: Mahr

full_name: Nicolas Mahr

family: Bouhake

full_name: Yannis Bouhake

given: Yannis

family: Liu

full_name: Ngai Liu

given: Ngai

family: Chazot

full_name: Thierry Chazot

given: Thierry

family: Samain

full_name: Emmanuel Samain

given: Emmanuel

family: Pili-Floury

full_name: Sebastien Pili-Floury

given: Sebastien

journal_name: Medicine

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health