title: Evaluation of the Efficiency of a Therapeutic Education Program in Standardized Thermal Cure for Fibromyalgia Patients

acronym: FiETT

summary: The study evaluates the efficiency, in terms of quality of life improvement, of a patient's therapeutic education program (ETP), based on long term commitment in adapted physical activities carried out during a standardized thermal cure (CTS) for fibromyalgia among patients continuing regular drug treatment or not

ReferenceCitation: Diatchenko L, Nackley AG, Slade GD, Fillingim RB, Maixner W. Idiopathic pain disorders--pathways of vulnerability. Pain. 2006 Aug;123(3):226-230. doi: 10.1016/j.pain.2006.04.015. Epub 2006 Jun 13. Review.

ReferenceCitation: Branco JC, Saraiva F et al. Fibromyalgia Syndrom : A european epidemiological survey. Abstract Sat 0452 Eular 2005

ReferenceCitation: Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum. 1995 Jan;38(1):19-28.

ReferenceCitation: Haute Autorité de Santé. Le syndrome fibromyalgique de l'adulte. Rapport d'orientation. Juillet 2010. 124p

ReferenceCitation: Laroche F. Actualités de la fibromyalgie. Rev Rhum 2009;76:529-36.

ReferenceCitation: Boureau F. Modèles théoriques cognitifs et comportementaux de la douleur chronique Doul et Analg 1999 ; 4 : 265-72

ReferenceCitation: Vlaeyen JWS. Place du concept de " peur de bouger " (ré) apparition du " mal " dans l'analyse et la réhabilitation comportementale des lombalgiques chroniques. Doul et Analg, 1999 ; 4 :281-8

ReferenceCitation: Pincus T, Burton AK, Vogel S, Field AP. A systematic review of psychological factors as predictors of chronicity/disability in prospective cohorts of low back pain. Spine (Phila Pa 1976). 2002 Mar 1;27(5):E109-20. Review.

ReferenceCitation: Bannwarth B, Blotman F, Le Lay K, Boussetta S, Caubère JP, André E, Taïeb C. Prévalence of fibromyalgia : a large-scale european survey : results in France Eular 2008, Paris, THU0392

ReferenceCitation: Maugars Y, Lamotte M, De Vos C C, Girard L, Caubère JP, André E, Le Lay K, Taïeb C. Fibromyalgia : the avoied cost of the non-diagnosed patient in France. Eular 2008, Paris, THU0386

ReferenceCitation: Boureau F. in Pratique du Traitement de la Douleur. Doin ed. 1988, 402p

ReferenceCitation: Weigent DA, Bradley LA, Blalock JE, Alarcón GS. Current concepts in the pathophysiology of abnormal pain perception in fibromyalgia. Am J Med Sci. 1998 Jun;315(6):405-12. Review.

ReferenceCitation: Mountz JM, Bradley LA, Modell JG, Alexander RW, Triana-Alexander M, Aaron LA, Stewart KE, Alarcón GS, Mountz JD. Fibromyalgia in women. Abnormalities of regional cerebral blood flow in the thalamus and the caudate nucleus are associated with low pain threshold levels. Arthritis Rheum. 1995 Jul;38(7):926-38.

ReferenceCitation: Valverde O, Micó JA, Maldonado R, Mellado M, Gibert-Rahola J. Participation of opioid and monoaminergic mechanisms on the antinociceptive effect induced by tricyclic antidepressants in two behavioural pain tests in mice. Prog Neuropsychopharmacol Biol Psychiatry. 1994 Oct;18(6):1073-92.

ReferenceCitation: Van Houdenove B, Luyten P. Fibromyalgia and related syndromes characterised by stress intolerance and pain hypersensitivity: do we need a new nosology ? Curr Rheumatol Rev 2007; 3: 304-308

ReferenceCitation: Marchand S. Influences des hormones sexuelles sur les mécanismes endogens impliqués dans le développement et la persistance de la douleur. Congrès SFETD, Nantes, 2006, Douleurs, nov.2006, CS04

ReferenceCitation: Ablin JN, Cohen H, Buskila D. Mechanisms of Disease: genetics of fibromyalgia. Nat Clin Pract Rheumatol. 2006 Dec;2(12):671-8. Review.

ReferenceCitation: Houvenagel E. Physiopathologie de la douleur de la fibromyalgie. Rev.Rhum.70(2003) :314-320

ReferenceCitation: Perrot S, Dumont D, Guillemin F, Pouchot J, Coste J; French Group for Quality of Life Research. Quality of life in women with fibromyalgia syndrome: validation of the QIF, the French version of the fibromyalgia impact questionnaire. J Rheumatol. 2003 May;30(5):1054-9.

ReferenceCitation: Mothe B, Etude comparée de l'efficacité thérapeutique de l'hypnose et de la relaxation dans la fibromyalgie. Universite de Paris VIII - Vincennes - Saint-Denis. Ecole Doctorale Cognition Langage Interaction. Laboratoire de

ReferenceCitation: Gerin P, Dazord A, Cialdella P, Leizorovicz A, Boissel JP. [The questionnaire "Profile of the subjective quality of life". First data of validation]. Therapie. 1991 Mar-Apr;46(2):131-8. French.

ReferenceCitation: Mailhan L. (2005). Qualité de vie après traumatisme crânien sévère. Pratiques psychologiques, 11, 343-357

ReferenceCitation: Dazord A, Mercier C, Manificat S, Nicolas J. (1995), Evaluation de la qualité de la vie : mise au point d'un instrument d'évaluation dans un contexte francophone, Revue Européenne de Psychologie Appliquée, 45, 4, 271-278

ReferenceCitation: Geenen R. Psychological approaches to management of fibromyalgia. Eular 2008, Paris, SP0124

ReferenceCitation: Mease P. Fibromyalgia syndrome: review of clinical presentation, pathogenesis, outcome measures, and treatment. J Rheumatol Suppl. 2005 Aug;75:6-21. Review. Erratum in: J Rheumatol Suppl. 2005 Oct;32(10):2063.

ReferenceCitation: Coichard CG, Cabane J et al.Intérêt d'une prise en charge multidisciplinaire du patient fibromyalgique. Rev.Rhum. (2003) ; 70 :354-7

ReferenceCitation: Cedraschi C, Desmeules J, Rapiti E, Baumgartner E, Cohen P, Finckh A, Allaz AF, Vischer TL. Fibromyalgia: a randomised, controlled trial of a treatment programme based on self management. Ann Rheum Dis. 2004 Mar;63(3):290-6.

ReferenceCitation: Goldenberg DL, Felson DT, Dinerman H. A randomized, controlled trial of amitriptyline and naproxen in the treatment of patients with fibromyalgia. Arthritis Rheum. 1986 Nov;29(11):1371-7.

ReferenceCitation: Miadsi D, Juniper MD. et al. The pharmacological management of fibromyalgia syndrome in the UK primary care setting. Eular, 2008, Paris. OP0076

ReferenceCitation: Russell IJ, Kamin M, Bennett RM, Schnitzer TJ, Green JA, Katz WA. Efficacy of tramadol in treatment of pain in fibromyalgia. J Clin Rheumatol. 2000 Oct;6(5):250-7.

ReferenceCitation: Biasi G, Manca S, Manganelli S, Marcolongo R. Tramadol in the fibromyalgia syndrome: a controlled clinical trial versus placebo. Int J Clin Pharmacol Res. 1998;18(1):13-9.

ReferenceCitation: Bennett RM, Kamin M, Karim R, Rosenthal N. Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled study. Am J Med. 2003 May;114(7):537-45.

ReferenceCitation: Sörensen J, Bengtsson A, Bäckman E, Henriksson KG, Bengtsson M. Pain analysis in patients with fibromyalgia. Effects of intravenous morphine, lidocaine, and ketamine. Scand J Rheumatol. 1995;24(6):360-5.

ReferenceCitation: Trèves R, Bannwarth B, Bertin P, Javier RM, Glowinski J, Le Bars M, Perrot S. Les Recommandations de Limoges. Usage de la morphine dans les douleurs rhumatismales non cancéreuses. Douleurs, 2000, 1,1, 33-38

ReferenceCitation: Moldofsky H, Scarisbrick P. Induction of neurasthenic musculoskeletal pain syndrome by selective sleep stage deprivation. Psychosom Med. 1976 Jan-Feb;38(1):35-44.

ReferenceCitation: Arnold LM. Biology and therapy of fibromyalgia. New therapies in fibromyalgia. Arthritis Res Ther. 2006;8(4):212. Review.

ReferenceCitation: Goldenberg DL. Management of fibromyalgia syndrome. Rheum Dis Clin North Am. 1989 Aug;15(3):499-512. Review.

ReferenceCitation: Tofferi JK, Jackson JL, O'Malley PG. Treatment of fibromyalgia with cyclobenzaprine: A meta-analysis. Arthritis Rheum. 2004 Feb 15;51(1):9-13.

ReferenceCitation: Wolfe F, Cathey MA, Hawley DJ. A double-blind placebo controlled trial of fluoxetine in fibromyalgia. Scand J Rheumatol. 1994;23(5):255-9.

ReferenceCitation: Arnold LM, Hess EV, Hudson JI, Welge JA, Berno SE, Keck PE Jr. A randomized, placebo-controlled, double-blind, flexible-dose study of fluoxetine in the treatment of women with fibromyalgia. Am J Med. 2002 Feb 15;112(3):191-7.

ReferenceCitation: Anderberg UM, Marteinsdottir I, von Knorring L. Citalopram in patients with fibromyalgia--a randomized, double-blind, placebo-controlled study. Eur J Pain. 2000;4(1):27-35.

ReferenceCitation: O'Malley PG, Balden E, Tomkins G, Santoro J, Kroenke K, Jackson JL. Treatment of fibromyalgia with antidepressants: a meta-analysis. J Gen Intern Med. 2000 Sep;15(9):659-66.

ReferenceCitation: Arnold LM, Keck PE Jr, Welge JA. Antidepressant treatment of fibromyalgia. A meta-analysis and review. Psychosomatics. 2000 Mar-Apr;41(2):104-13.

ReferenceCitation: Goldenberg DL, Clauw DJ, Palmer RH, Mease P, Chen W, Gendreau RM. Durability of therapeutic response to milnacipran treatment for fibromyalgia. Results of a randomized, double-blind, monotherapy 6-month extension study. Pain Med. 2010 Feb;11(2):180-94. doi: 10.1111/j.1526-4637.2009.00755.x. Epub 2009 Dec 9.

ReferenceCitation: Branco JC, Zachrisson O, Perrot S, Mainguy Y; Multinational Coordinator Study Group. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia. J Rheumatol. 2010 Apr;37(4):851-9. doi: 10.3899/jrheum.090884. Epub 2010 Feb 15.

ReferenceCitation: Chappell AS, Littlejohn G, Kajdasz DK, Scheinberg M, D'Souza DN, Moldofsky H. A 1-year safety and efficacy study of duloxetine in patients with fibromyalgia. Clin J Pain. 2009 Jun;25(5):365-75. doi: 10.1097/AJP.0b013e31819be587.

ReferenceCitation: Russell JI, Mease PJ, Smith TR, Kajdasz DK, Wohlreich MM, Detke MJ, Walker DJ, Chappell AS, Arnold LM. Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: Results from a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial. Pain. 2008 Jun;136(3):432-444. doi: 10.1016/j.pain.2008.02.024. Epub 2008 Apr 18.

ReferenceCitation: Zijlstra TR, Barendregt PJ, van De Laar MA. Venlafaxine in fibromyalgia: results of a randomized placebo-controlled, double-blind trial. Arthritis Rheum. 2002;46:S105

ReferenceCitation: Clère F, Henry F, Perriot M. Quelle place pour le clonazepam dans la douleur chronique ? Douleurs, vol7n°6 dec 2006 :314-317

ReferenceCitation: Arnold LM, Goldenberg DL, Stanford SB, Lalonde JK, Sandhu HS, Keck PE Jr, Welge JA, Bishop F, Stanford KE, Hess EV, Hudson JI. Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial. Arthritis Rheum. 2007 Apr;56(4):1336-44.

ReferenceCitation: Crofford LJ, Rowbotham MC, Mease PJ, Russell IJ, Dworkin RH, Corbin AE, Young JP Jr, LaMoreaux LK, Martin SA, Sharma U; Pregabalin 1008-105 Study Group. Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2005 Apr;52(4):1264-73.

ReferenceCitation: Arnold LM, Crofford LJ, Martin SA, Young JP, Sharma U. The effect of anxiety and depression on improvements in pain in a randomized, controlled trial of pregabalin for treatment of fibromyalgia. Pain Med. 2007 Nov-Dec;8(8):633-8.

ReferenceCitation: Barrett J, Russell J, Pauer L, Whalen E, Leon T, Zeiher B. The effect of pregabalin treatment on changes in pain and sleep quality in fibromyalgia patients.Eular 2008, Paris, THU0362

ReferenceCitation: Arkfeld DG, Setoodeh KM, Abrahim J, Cole SE, Metyas S. The inability of most us patients to tolerate the recommended doses of pregabalin in the treatment of fibromyalgia ;: a case study. Elar 2008, Paris, THU0396

ReferenceCitation: Wood PB, Schweinhardt P, Jaeger E, Dagher A, Hakyemez H, Rabiner EA, Bushnell MC, Chizh BA. Fibromyalgia patients show an abnormal dopamine response to pain. Eur J Neurosci. 2007 Jun;25(12):3576-82.

ReferenceCitation: Holman AJ, Myers RR. A randomized, double-blind, placebo-controlled trial of pramipexole, a dopamine agonist, in patients with fibromyalgia receiving concomitant medications. Arthritis Rheum. 2005 Aug;52(8):2495-505.

ReferenceCitation: Bennett RM, Clark SC, Walczyk J. A randomized, double-blind, placebo-controlled study of growth hormone in the treatment of fibromyalgia. Am J Med. 1998 Mar;104(3):227-31.

ReferenceCitation: Clark S, Tindall E, Bennett RM. A double blind crossover trial of prednisone versus placebo in the treatment of fibrositis. J Rheumatol. 1985 Oct;12(5):980-3.

ReferenceCitation: Russell u, Bennett RM, Michalek JE. Sodium oxybrate relieves pain and improves sleep in fibromyalgia syndrome. A randomized, double-blind, placebo-controlled, multi-center clinical trial. ACR/ARHP Scientific Meeting. 2005; programm book supplement:late-breaking abstracts

ReferenceCitation: Holdcraft LC, Assefi N, Buchwald D. Complementary and alternative medicine in fibromyalgia and related syndromes. Best Pract Res Clin Rheumatol. 2003 Aug;17(4):667-83. Review.

ReferenceCitation: Sarac AJ, Gur A. Complementary and alternative medical therapies in fibromyalgia. Curr Pharm Des. 2006;12(1):47-57. Review.

ReferenceCitation: Perrot S, Maheu E, Javier RM, Eschalier A, Coutaux A, LeBars M, Bertin P, Bannwarth B, Trèves R. Guidelines for the use of antidepressants in painful rheumatic conditions. Eur J Pain. 2006 Apr;10(3):185-92. Epub 2005 Apr 18. Review.

ReferenceCitation: Journal Officiel de la République Française, 9 août 2006. Arrêté du 1er août 2006 portant approbation d'un avenant à la convention nationale thermale.

ReferenceCitation: Thermalisme et santé publique vers de nouvelles convergences. Livre Blanc CNETH 2008.

ReferenceCitation: Rapport 2011 du Conseil National du Tourisme pour le Ministre chargé du Tourisme " réflexions et propositions sur la diversification des stationsThermales ".

ReferenceCitation: Bellometti S, Galzigna L. Function of the hypothalamic adrenal axis in patients with fibromyalgia syndrome undergoing mud-pack treatment. Int J Clin Pharmacol Res. 1999;19(1):27-33.

ReferenceCitation: Adler GK, Geenen R. Hypothalamic-pituitary-adrenal and autonomic nervous system functioning in fibromyalgia. Rheum Dis Clin North Am. 2005 Feb;31(1):187-202, xi. Review.

ReferenceCitation: McLean SA, Williams DA, Harris RE, Kop WJ, Groner KH, Ambrose K, Lyden AK, Gracely RH, Crofford LJ, Geisser ME, Sen A, Biswas P, Clauw DJ. Momentary relationship between cortisol secretion and symptoms in patients with fibromyalgia. Arthritis Rheum. 2005 Nov;52(11):3660-9.

ReferenceCitation: Dönmez A, Karagülle MZ, Tercan N, Dinler M, Işsever H, Karagülle M, Turan M. SPA therapy in fibromyalgia: a randomised controlled clinic study. Rheumatol Int. 2005 Dec;26(2):168-72. Epub 2005 Jun 17.

ReferenceCitation: Zijlstra TR, van de Laar MA, Bernelot Moens HJ, Taal E, Zakraoui L, Rasker JJ. Spa treatment for primary fibromyalgia syndrome: a combination of thalassotherapy, exercise and patient education improves symptoms and quality of life. Rheumatology (Oxford). 2005 Apr;44(4):539-46. Epub 2005 Feb 3.

ReferenceCitation: Fioravanti A, Perpignano G, Tirri G, Cardinale G, Gianniti C, Lanza CE, Loi A, Tirri E, Sfriso P, Cozzi F. Effects of mud-bath treatment on fibromyalgia patients: a randomized clinical trial. Rheumatol Int. 2007 Oct;27(12):1157-61. Epub 2007 May 23.

ReferenceCitation: C. Robert, Fibromyalgie et cures thermales. Journée d'Automne de l'Institut du thermalisme Dax 27/11/2009

ReferenceCitation: Carville SF, Arendt-Nielsen L, Bliddal H, Blotman F, Branco JC, Buskila D, Da Silva JA, Danneskiold-Samsøe B, Dincer F, Henriksson C, Henriksson KG, Kosek E, Longley K, McCarthy GM, Perrot S, Puszczewicz M, Sarzi-Puttini P, Silman A, Späth M, Choy EH; EULAR. EULAR evidence-based recommendations for the management of fibromyalgia syndrome. Ann Rheum Dis. 2008 Apr;67(4):536-41. Epub 2007 Jul 20. Review. Erratum in: Ann Rheum Dis. 2015 Feb;74(2):476. Arendt-Nielsen, S [corrected to Arendt-Nielsen, L].

ReferenceCitation: Simon D, Traynard PY, Bourdillon F, Gagnaire R, Grimaldi A. Education thérapeutique, prévention et maladies chroniques. Masson. 2ème édition 2011.

ReferenceCitation: Résultats de l'étude TNS Healthcare auprès de 112 000 curistes 2006 source CNETH 1 rue Cels 75016 Paris.

ReferenceCitation: Ducamp Ph.Le thermalisme peut-il être le lieu idéal de la prise en charge des patients fibromyalgiques ? Mémoire de fin d'études du diplôme universitaire d'éducation thérapeutique de formation et de coordination d'équipe. UMFMC Université Bordeaux Segalen 2012.

ReferenceCitation: Ducamp Ph. Journées Nationales du thermalisme Luchon Nov 2012. La place des médecins thermaux dans l'éducation thérapeutique.

ReferenceCitation: Haute Autorité de Santé. Guide méthodologique

ReferenceCitation: Sichère P. Fibromyalgie, éducation thérapeutique, thermalisme. Mémoire de fin d'études et de formation à l'éducation thérapeutique IPCEM. IPCEM 2012.

ReferenceCitation: Sichère P, Ducamp P. Fibromyalgie, éducation thérapeutique, thermalisme. Congrès national de la Société Française de Rhumatologie (M149) Paris 8-12 décembre 2012.

ReferenceCitation: Ducamp Ph. Fibromyalgie, éducation thérapeutique et thermalisme. La presse thermale et climatique, Nov 2011.

ReferenceCitation: Sichère P. Evaluation, diagnostics, traitements. Douleurs 2012; 13: 244-6: Douleurs et thermalisme: questions posées au Dr Philippe Ducamp.

ReferenceCitation: Sichère P et Ducamp P. Éducation thérapeutique, fibromyalgie et thermalisme. Douleurs 2013; 14: 22-9.

ReferenceCitation: Françon A, Queneau P. Quelle place pour la crénothérapie dans la fibromyalgie ? Abrégé " Médecine thermale. Faits et preuves ". P. Queneau et coll. Edition Masson 2000, p 75-77

ReferenceCitation: Françon A. Fibromyalgie et thermalisme. N°125-14-janvier 2010-reflexions Rhumato.p15-18

ReferenceCitation: D'Ivernois JF, Gagnayre R. Propositions pour l'évaluation de l'éducation thérapeutique. In ADSP, n°58, mars 2007

ReferenceCitation: Foucaud J, Bury JA, Balcou-Debussche M, Eymard C. Education thérapeutique du patient : Modèles, pratiques et évaluation. Dir. Saint Denis INPES, collection Santé en Action, 2010 : 412p.

ReferenceCitation: Roberts PJ, Roberts C, Sibbald B, Torgerson DJ. Increasing response rates to postal questionnaires. Effect of incentives on response rates must be considered. BMJ. 2002 Aug 24;325(7361):444.

ReferenceCitation: Perrot S, Bouhassira D, Fermanian J; CEDR (Cercle d'Etude de la Douleur en Rhumatologie). Development and validation of the Fibromyalgia Rapid Screening Tool (FiRST). Pain. 2010 Aug;150(2):250-256. doi: 10.1016/j.pain.2010.03.034. Epub 2010 May 21.

ReferenceCitation: Huet AG. Une expérience d'Art-Thérapie, à dominante danse, auprès des personnes fibromyalgiques. Université François Rabelais ; UFR médecine Tours. 2011.

ReferenceCitation: Graber-Duvernay B. Dix ans de surveillance épidémiologique des pneumopathies à Aix-les-Bains (1990 - 1999). Presse Therm Clim 2001; 138: 13-25

ReferenceCitation: Gerbaud L, Maire A, Devaux I, Chadès C, Riguidel Ph, Vidal A, Glanddier Ph Y. La surveillance des incidents infectieux chez les curistes thermaux en auvergne synthèse de 8 années d'expérience de réseaux sentinelles. Presse Therm Clim 2001; 138: 41-50

ReferenceCitation: Fournet D. La surveillance des incidents infectieux chez les curistes de Balaruc-les-Bains. Presse Therm Clim 2001; 138: 51-53

ReferenceCitation: Françon A, Graber-Duvernay B, Forestier R, Palmer M. Incidence des évènements infectieux dans une population de curistes présumés vulnérables. Presse Therm Clim 2001; 138: 55-65

ReferenceCitation: Leclerc H. Bactériologie de Pseudomonas aeruginosa. Presse Therm Clim 2002; 139: 9-13

ReferenceCitation: Ruimy R. Pathogénicité de Pseudomonas aeruginosa en dehors de la mucoviscidose. Presse Therm Clim 2002; 139: 15-21

ReferenceCitation: Tancréde-Bohin E. Pseudomonas et infections cutanées. Presse Therm Clim 2002; 139: 23-28

ReferenceCitation: Barry B. Pseudomonas aeruginosa et infections ORL. Presse Therm Clim 2002; 139: 29-33

ReferenceCitation: Graber-Duvernay B. Pseudomonas aeruginosa et infections broncho-pulmonaires. Presse Therm Clim 2002; 139: 35-40

ReferenceCitation: Morin J.P, Graber-Duvernay B. Surveillance des pseudomonas et expériences de désinfection. Presse Therm Clim 2002; 139: 41-51

ReferenceCitation: Hartemann Ph. Quelles mesures préconiser pour une gestion raisonnée du risque dû a Pseudomonas aeruginosa ? Presse therm climat 2002; 139: 53-57

ReferenceCitation: Nguyen Ba B, Dubourg K, Pécastaings S, Optimisation de la lutte contre les légionnelles et autres opportunistes dans les réseaux d'eau minérale naturelle, grâce à un pilote "eau thermale". Press Therm Clim 2006;143:7-123

ReferenceCitation: R Forestier, A Françon, Graber-Duvernay B, Palmer M, sevez JF, Guillemot A, BErnard JP, Souchon JF, Gerrud S, Le Provost C, Joly J, Rogeaux O, Deschamps O. Incidence des événements infectieux survenus en cure thermale dans une population de curistes présu- més vulnérables : étude contrôlée longitudinale sur 738 patients. Press Therm Clim 2008;145:9-21

ReferenceCitation: Dubourg K, Grégoire P, Lagière J. La désinfection des piscines thermales de Dax. Press Therm Clim 2008;145:61-71

ReferenceCitation: Ducamp P. Fibromyalgie et thermalisme. 10ème Congrès National de la Fibromyalgie FNAFF. Nîmes, 13 octobre 2012.

ReferenceCitation: Grille OPTIMON évaluant le risque patient dans les études de recherche clinique institutionnelles

ReferenceCitation: Sous-groupe de travail Qualité de la promotion - Plan de monitoring adapté - DRCI Hospices Civils de Lyon. Elaboration du plan de monitoring adapté pour une recherche biomédicale à promotion institutionnelle

ReferenceCitation: Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol. 2009 Jun;36(6):1304-11. doi: 10.3899/jrheum.081090. Epub 2009 Apr 15.

lead_sponsor: Association Francaise pour la Recherche Thermale


type: Other Identifier

title: Characterisation by Electric Impedance Measurements of the Different Wound Healing Phases of Diabetic Foot Ulcers

acronym: BIPPED

summary: The BIPPED study seeks to determine whether wound healing, in particular diabetic foot ulcers, can be monitored using electrical bioimpedance analysis (BIA). BIA measures the resistance of biological tissue to the passage of a very small electric current applied with electrodes. Different types of tissue, due to cell structure, hydration and vascularization, have specific electrical characteristics. The BIPPED study aims to provide experimental data for the development of a BIA sensor for monitoring of wound healing in chronic wounds.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Lukaski HC, Moore M. Bioelectrical impedance assessment of wound healing. J Diabetes Sci Technol. 2012 Jan 1;6(1):209-12. Review.

lead_sponsor: University Hospital, Grenoble

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


type: Registry Identifier

title: Identification of the Blood Microbiota in Patient Suffering From Myocardial Infraction

acronym: FLORINF

summary: The investigators want to compare blood microbiota profile between patients with documented coronary lesions and patients free of coronary disease.

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Amar J, Lelouvier B, Servant F, Lluch J, Burcelin R, Bongard V, Elbaz M. Blood Microbiota Modification After Myocardial Infarction Depends Upon Low-Density Lipoprotein Cholesterol Levels. J Am Heart Assoc. 2019 Oct;8(19):e011797. doi: 10.1161/JAHA.118.011797. Epub 2019 Sep 28.

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse


title: Microglial Activation Role In ALS (MARIA)

acronym: MARIA

summary:
Neuroinflammation, characterized in particular by microglia activation, is an essential component of Amyotrophic Lateral Sclerosis (ALS) pathogenesis. Translocator Protein (TSPO) is recognized as a specific and sensitive biomarker of neuroinflammation, reflecting disease activity. An experimental radiopharmaceutical specific of TSPO expression, namely [18F]DPA714, allow to quantify this microglial activation using Positon Emission Tomography (PET) imaging.

The purpose of this study is to longitudinally correlate the spatial distribution of neuroinflammation with the pro- or anti-inflammatory state of activated microglia cells in ALS, in order to evaluate neurotoxic or neuroprotective microglia activity, by complementary approaches in 20 ALS patients:

in vitro: measuring concentrations of several pro- and anti-inflammatory cytokines secreted by microglial cells in the cerebrospinal fluid (CSF).
in vivo: [18F]DPA714 PET imaging. These assays will be performed in the framework of the clinical follow-up of ALS patients, at the diagnosis of ALS disease and 6 months latter.

study_start_date_type: Anticipated

status: Withdrawn

study_completion_date_type: Anticipated

ReferenceType: result

ReferenceCitation: Corcia P, Valdmanis P, Millecamps S, Lionnet C, Blasco H, Mouzat K, Daoud H, Belzil V, Morales R, Pageot N, Danel-Brunaud V, Vandenberghe N, Pradat PF, Couratier P, Salachas F, Lumbroso S, Rouleau GA, Meininger V, Camu W. Phenotype and genotype analysis in amyotrophic lateral sclerosis with TARDBP gene mutations. Neurology. 2012 May 8;78(19):1519-26. doi: 10.1212/WNL.0b013e3182553c88. Epub 2012 Apr 25.

ReferenceCitation: Blasco H, Corcia P, Moreau C, Veau S, Fournier C, Vourc'h P, Emond P, Gordon P, Pradat PF, Praline J, Devos D, Nadal-Desbarats L, Andres CR. 1H-NMR-based metabolomic profiling of CSF in early amyotrophic lateral sclerosis. PLoS One. 2010 Oct 8;5(10):e13223. doi: 10.1371/journal.pone.0013223.

ReferenceCitation: Arlicot N, Vercouillie J, Ribeiro MJ, Tauber C, Venel Y, Baulieu JL, Maia S, Corcia P, Stabin MG, Reynolds A, Kassiou M, Guilloteau D. Initial evaluation in healthy humans of [18F]DPA-714, a potential PET biomarker for neuroinflammation. Nucl Med Biol. 2012 May;39(4):570-8. doi: 10.1016/j.nucmedbio.2011.10.012. Epub 2011 Dec 14.

ReferenceCitation: Corcia P, Ingre C, Blasco H, Press R, Praline J, Antar C, Veyrat-Durebex C, Guettard YO, Camu W, Andersen PM, Vourc'h P, Andres CR. Homozygous SMN2 deletion is a protective factor in the Swedish ALS population. Eur J Hum Genet. 2012 May;20(5):588-91. doi: 10.1038/ejhg.2011.255. Epub 2012 Jan 25.

ReferenceCitation: Corcia P, Tauber C, Vercoullie J, Arlicot N, Prunier C, Praline J, Nicolas G, Venel Y, Hommet C, Baulieu JL, Cottier JP, Roussel C, Kassiou M, Guilloteau D, Ribeiro MJ. Molecular imaging of microglial activation in amyotrophic lateral sclerosis. PLoS One. 2012;7(12):e52941. doi: 10.1371/journal.pone.0052941. Epub 2012 Dec 31.

lead_sponsor: University Hospital, Tours

intervention_type: Drug

status_simplified: Unknown


title: Evaluation Des rééducations Neuropsychologiques Des Troubles de l'Inhibition Chez l'Enfant Avec un TDAH

acronym: ERNTITDAH

summary: This research aims to assess the cognitives rehabilitations in attention deficit disorder (ADHD) in children. the objective is to demonstrate what are the most relevant cognitive factors for rehabilitative to improve the inhibition of disorders in ADHD.

status: Unknown status

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône


title: A Novel BCI-controlled Pneumatic Glove System for Neurorehabilitation Post-stroke

acronym: BCI-stroke

summary: The goal is to evaluate the potential of a EEG based BCI (Brain-Computer-Interface) connected to a non-invasive pneumatic glove for rehabilitation of hand-movements post-stroke.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Montpellier

intervention_type: Device


acronym: THIC Cu

title: Treatment of Intracranial Hypertension of Severe Tramatic Brain Injured Patients. Physiopathologic Effects of Neuromuscular Blocking Agents. A Controlled Randomized Study Versus Placebo

lead_sponsor: University Hospital, Clermont-Ferrand

type: EudraCT Number

source: euctr

study_start_date_type: Actual

summary:
Severely brain injured patients are at high risk of intracranial hypertension. Among medical treatments (sedatives), neuromuscular blocking agents (NMBA) are recommended by french but not english speaking societies.

Effects of NMBA are unknown. The present study is designed to compare the effects of NMBA versus placebo in the treatment of intracranial hypertension, and the underlying physiopathologic effects.


status: Terminated

acronym: PANCREADOGREL

title: A Phase III Multi-centre Double-blind Placebo Controlled Study Analysing the Efficacy and Safety of Daily Administration of a P2Y12 Inhibitor (Clopidogrel) for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service d'oncologie digestive - Institut Sainte Catherine

summary:
Clopidogrel has been shown to slow down tumor progression in orthoptic pancreatic murine tumor.

In a pilot study, the rate of microparticles was correlated with response rate of pancreatic adenocarcinoma.

The aim of the study is;

to compare the phenotypes of coagulation, the tumor progression and metastasis formation with and without clopidogrel treatment in association with chemotherapy in advanced pancreatic cancer patients
to correlate the decrease of microparticles levels after one month of chemotherapy with tumor response (ancillary study)


title: Betaine METABOLISM OF PATIENTS With Homocystinuria

acronym: HCTBETAINE

summary:
Oral treatment with betaine is conventionally used for patients with inherited homocystinurias.

These conditions include a first group of patients with a cystathionine β-synthase (CBS) deficiency and a second group of patients with remethylation defects.

The aim of betaine therapy is to reduce level of total plasma homocysteine. Daily dosages and rhythm of administration proposed in the literature vary between 100 to 250 mg / kg / d in 2 to 4 doses. These dosages are not based on validated data and several publications mention much higher dosages particularly when total homocysteine is not controlled. These practices may be unnecessary or even detrimental given the fact that high doses of betaine could for example lead to secondary folate deficiency.

ReferenceCitation: Imbard A, Toumazi A, Magréault S, Garcia-Segarra N, Schlemmer D, Kaguelidou F, Perronneau I, Haignere J, de Baulny HO, Kuster A, Feillet F, Alberti C, Guilmin-Crépon S, Benoist JF, Schiff M. Efficacy and pharmacokinetics of betaine in CBS and cblC deficiencies: a cross-over randomized controlled trial. Orphanet J Rare Dis. 2022 Nov 14;17(1):417. doi: 10.1186/s13023-022-02567-4.


title: Identification of the Mechanisms of Action of Intravenous Immunoglobulins in CIDP by Analysis of the Genetic Expression Profile in Blood Mononuclear Cells

acronym: PHARMACOPID

summary: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated disorder of peripheral nerves. Intravenous immunoglobulins (IVIg) are a first line therapy for CIDP. The investigators used a transcriptomic approach to compare the gene expression profiles in the peripheral blood of patients having a CIDP or autoimmune diseases, before and after IVIg treatment, in order to identify their mechanism of action in this condition, to lead to a better understanding of CIDP pathophysiology, and potentially determine factors associated with the response to the treatment.


acronym: GICAC

summary: In this prospective, randomized study, the investigators assess the intubation conditions during videolaryngoscopy with Glidescope Titanium whether patients receive (curare (Atracurium) group) or no (control group) within elective surgery patients with no difficult intubation prediction

lead_sponsor: CHU de Reims


title: Treatment of Multiple Sclerosis With Mesenchymal Stem Cells: Phase I/II Study

acronym: MESEMS

summary:
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS), which ultimately leads to myelin damage and axonal loss. The disease is complex and multifactorial, but the key pathogenic event appears to be an uncontrolled response of components of the immune system (T and B lymphocytes) to myelin proteins. No definitive treatment is available for MS, however immunomodulatory and immunosuppressant drugs act as disease-modifying agents (DMDs).

Unfortunately, the current treatments demonstrate partial efficacy in targeting the deleterious immune reactions. According to the present knowledge of the pathophysiology of MS, an ideal therapeutic strategy would be to modulate or suppress the aggressive immune process, to protect axons and neurons from degeneration, and to enhance repair and facilitate remyelination.

A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown remarkable ability to modulate the immune response. This study will evaluate the safety of injecting MSCs in people with MS.

ReferenceCitation: Uccelli A, Laroni A, Brundin L, Clanet M, Fernandez O, Nabavi SM, Muraro PA, Oliveri RS, Radue EW, Sellner J, Soelberg Sorensen P, Sormani MP, Wuerfel JT, Battaglia MA, Freedman MS; MESEMS study group. MEsenchymal StEm cells for Multiple Sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for the therapy of multiple sclerosis. Trials. 2019 May 9;20(1):263. doi: 10.1186/s13063-019-3346-z.


title: Implantation Feasibility Study of a Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease (Smart in Vivo 2)

summary: This study aims to demonstrate innocuity and feasibility of deep brain stimulation with a multi-electrodes set.


title: Effect of the Transcranial Direct Current Stimulation on the Dopaminergic

acronym: DOPA-STIM

summary:
Transcranial direct current stimulation (tDCS) is a technique that is emerging as a prospective therapy for neurologic, psychiatric and addictive disorders. Specifically, anodal tDCS applied over the dorsolateral prefrontal cortex (DLPFC) is associated with improvement of cognitive functions and mood. Despite an increased use in clinical settings, tDCS suffers from limitations, especially regarding the strength and the duration of therapeutic effects. Strategies to optimize the conditions for tDCS application suffer from the lack of knowledge about its neurophysiological impact. Moreover, tDCS is increasingly used in private settings through commercial apparatus and tutorials to make a "do-it-yourself" device delivering tDCS now available on the Internet. This private use worries neuroscientists and health authorities. Even if the general impression is that, in controlled conditions, tDCS is safe with only mild and transient adverse effects, whether and how tDCS could be used for enhancing cognition in healthy subjects are needed to investigate in more detail. The investigators believe that a better understanding of some neurobiological effects of tDCS is crucial to further tailor tDCS for experimental and therapeutic applications and to define recommendations for a private use.

As the cortex is densely connected with basal ganglia areas, including dopaminergic areas, tDCS is probably not only capable to target cortical but also subcortical structures remote from the stimulation sites. Some studies suggest that cortical stimulation by other approaches, such as transcranial magnetic stimulation (rTMS) leads to an increased dopaminergic transmission. The involvement of dopaminergic systems in tDCS effects has been investigated only indirectly in pharmacological studies. Thus, the direct effect of the DLPFC stimulation by tDCS on dopaminergic transmission is still unknown.

The aim of this project is to reveal the online impact of a single-session of tDCS applied bilaterally over the DLPFC in healthy subjects on the dopaminergic transmission measured by PET, combined with the [11C]raclopride bolus-plus-continuous-infusion method.

lead_sponsor: Hôpital le Vinatier


title: MRI for the Etiological Diagnosis of Orbital Tumours

acronym: MEDORT

summary:
Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid structures or vascular structures. These masses can be tumors, benign or malignant, or pseudotumor, mainly represented by specific or non-specific orbital inflammation.

Pathology is of considerable importance for the diagnosis and the treatment of those masses. However, biopsy or surgical resection of the orbital masses is sometimes difficult and dangerous outside expert centers.

The identification of a non-invasive technique for distinguishing tumors from pseudotumors, thus avoid in some cases a biopsy, would be a major contribution for the patients.

The MRI assessment performed routinely in a patient with an orbital mass includes morphological sequences T1, T2 fat suppression, T1 injected fat suppression, diffusion. This exploration requires, regardless of the performed research, a contrast agent injection (0.1 mg / kg weight of Gadobutrol®).

In this research protocol, during the injection of the contrast agent performed during the MRI assessment performed routinely, a DCE perfusion sequence, which consists of a repeated acquisition at short intervals of a volume gradient echo T1, will be added. This acquisition will be preceded by two short series for calibration. The post treatment will include parametric permeability cards (Ktrans) and plasmatic volume (Vp), evaluating one or more regions of interest in the tumor, normal lacrimal glands, jaw muscles and nasal mucosa being the reference. It will also be added a magnetic susceptibility EPI sequence type. All the qualitative parameters (T1, T2, T1 injected, distribution, low signal intensity in susceptibility) and quantitative (Ktrans, Vp, relative intensity enhancement, apparent diffusion coefficient) parameters will be collected.

The result of the pathological exam of the biopsy or of the surgical specimen, which is the gold-standard, will be collected.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmique Adolphe de Rothschild

lead_sponsor_type: industriel


title: Study About Contamination of Testicle Tissue by RT-PCR in Children With Solid Tumors

acronym: TESTIMAR

summary: For prepubertal patients, cryopreservation of testicular tissue is the only option available to preserve their fertility before cancer treatment. But testicular autograft raises the issue of the risk of reintroduction of potentially malignant cells. The aim of our study is to develop a specific and sensitive method for residual disease detection in the testicular tissue from patients treated for a solid tumor during infancy, whose fertility may have been compromised by treatments and who benefited of testicular tissue cryopreservation.

ReferenceCitation: Chaput L, Grèze V, Halle P, Radosevic-Robin N, Pereira B, Véronèse L, Lejeune H, Durand P, Martin G, Sanfilippo S, Canis M, Kanold J, Tchirkov A, Brugnon F. Sensitive and Specific Detection of Ewing Sarcoma Minimal Residual Disease in Ovarian and Testicular Tissues in an In Vitro Model. Cancers (Basel). 2019 Nov 17;11(11). pii: E1807. doi: 10.3390/cancers11111807.


title: Research a New Predictive Marker of Intraventricular Hemorrhage in Very Preterm Infants: HEMO PREMA Study

acronym: HEMO PREMA

summary:
The most frequent complications in premature infants are neurological complications: intracranial hemorrhages and white matter lesions. In Epipage 2 study the incidence of severe intraventricular hemorrhages remains stable. Severe hemorrhages are associated with neurological sequelae.

A recent study in humans and in animals shows the role of the complex formed by plasminogen activator (t-PA) and its inhibitor (PAI-1) in the induction of vascular fragility via stromelysin (MMP-3). FIBRINAT study in Rouen University Hospital showed a rate of complex t-PA-PAI1 probably very high in preterm infants. An other factor maturation PDGF-C induced by t-PA is associated with the vascular embrittlement. Among the few genetic factors associated with cerebral palsy include 2 SNP of PAI-1 gene and one SNP in the gene of endothelial NO synthase.

The hypothesis is that a high rate of the complex t-PA-PAI-1 in cord blood could be a high risk of intracranial hemorrhage in preterm infants and provide predictive of their occurrence. The rates of MMP-3, PDGF-C and PAI-1 free in cord blood, and the polymorphism of PAI-1 gene and eNOS could separately or associated with the main criterion to identify predictive of hemorrhages.

The main objective is to search a rate difference of the complex t-PA-PAI-1 in cord blood of preterm infants (before 30 weeks of gestation) that would predict intracranial hemorrhage coming in the first days of life.

The secondary objectives are

Evaluate potential marker risk of high levels of MMP-3, PAI-1 free, and PDGF-CC

Search in both groups the presence of alleles -675G4 / G5 and 11053 (G / T) of the PAI-1 gene and -922 (A / G) of the eNOS gene.

120 preterm infants will be included before 30 weeks of gestation with precise inclusion and exclusion criteria during a period of 3 years.

Patients will be divided into two groups according to whether they will or not showed intracranial hemorrhage (detected by ultrasound J5-J7).

The complex rate tPA-PAI-1, PAI-1 free, MMP-3 and PDGF-C will be measured. The comparison between the two groups will be carried out using statistical tests. Comparison of the presence of the alleles -675 4G and 11053T the PAI-1 gene or -922G eNOS gene between the two groups will be performed.

The demonstration of this hypothesis would permit to identify children from birth in whom the immediate implementation of preventive treatment of bleeding is desirable.

design_allocation: Non-Randomized

primary_purpose: Prevention

lead_sponsor: University Hospital, Rouen

intervention_type: Procedure


title: Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging

acronym: DRAGON

summary: Acute heart allograft rejection is a common complication after orthotopic heart transplantation. Primary objective of this study is to assess cardiac MRI as a tool for acute heart graft rejection screening, by detecting changes in myocardium structure especially extracellular volume.

primary_purpose: Screening


title: Study About Contamination of Ovarian Tissue by RT-PCR in Children With Solid Tumors.

acronym: OVAMAR

summary: For prepubertal patients, cryopreservation of ovarian tissue is the only option available to preserve their fertility before cancer treatment. But ovarian autograft raises the issue of the risk of reintroduction of potentially malignant cells. The aim of our study is to develop a specific and sensitive method for residual disease detection in the ovarian tissue from patients treated for a solid tumor during infancy, whose fertility may have been compromised by treatments and who benefited of ovarian tissue cryopreservation.


title: Prospective Evaluation of Neuropsychological and Clinical Impact of Cognitive Remediation Program Among Children and Adolescents Treated for Anorexia Nervosa

acronym: RECOGAMEA

summary: The aim of research is to test in a randomized clinical trial with active sessions, the efficacy of cognitive remediation therapy in children anorexia nervosa compared to a controlled group. The investigators want to confirm the efficacy of cognitive remediation treatment in children's flexibility problems.


title: Prevention of Ventilator Associated Pneumonia With Toothbrushing in Oral Care of Critically Ill Mechanically Ventilated Patients

summary: Effect of toothbrushing in oral care of mechanically ventilated critically ill patients on prevention of ventilator associated pneumonia

time_perspective: Cross-Sectional

ReferenceCitation: Ory J, Mourgues C, Raybaud E, Chabanne R, Jourdy JC, Belard F, Guérin R, Cosserant B, Faure JS, Calvet L, Pereira B, Guelon D, Traore O, Gerbaud L. Cost assessment of a new oral care program in the intensive care unit to prevent ventilator-associated pneumonia. Clin Oral Investig. 2018 Jun;22(5):1945-1951. doi: 10.1007/s00784-017-2289-6. Epub 2017 Nov 30.


title: Study of Bacterial Colonization of the Respiratory Tract in Long-term Tracheostomized Patients With Neurological or Neuromuscular Disease

acronym: ECOTRACH

summary: Patients with neurological or neuromuscular diseases may need a long-term tracheostomy to improve their respiratory function. Bacterial flora and bacterial drug resistance in the respiratory tract have never been studied until then for this type of patient in spite of their frequent hospital stay, their regular exposition to antibiotics and their susceptibility to swallowing disorders due to their pathology. This study is based on a single tracheal aspirate within the 48 first hours of the patient stay for a ventilation check up beside any infectious context to describe the basal bacterial respiratory flora.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


acronym: DEXA OP

title: Dexamethasone, Can it Replace Ketoprofen in the Strategy of Intraoperative Multimodal Analgesia in Paediatric Surgery ? A Prospective Randomized Double-blinded Study. DEXA OP

lead_sponsor: Rennes University Hospital

summary:
Postoperative pain and nausea-vomiting (PONV) are the first causes of failure in ambulatory care in pediatric surgery. Actually, the paracetamol/ketoprofen combination in intraoperative care is recommended for effective postoperative analgesia in children. However, intravenous ketoprofen doesn't have the marketing authorization for use in children less than 15 years old and its use is mainly justified by the absence of therapeutic alternatives. Recently, findings from published studies suggest that dexamethasone (DXM), which is actually recommended to prevent PONV for children "at risk", at a dose of 0.1mg/kg, would have analgesic properties above 0.15 mg/kg comparable to non-steroidal anti-inflammatories (NSAI).

Main objective :

To examine the effects of intraoperative DXM (0.2mg/kg and 0.4mg/kg) on the intensity of postoperative pain in the post-anaesthetic care unit (PACU) compared to ketoprofen (1mg/kg).

Secondary objectives :

To examine the effects of intraoperative DXM (0.2mg/kg and 0.4mg/kg) compared to ketoprofen (1mg/kg) on the anesthesia emergence delirium, the intensity of postoperative pain, the consumption of rescue analgesics and the side effects in the first 24 hours after surgery.


title: Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis: Analysis of Phonatory and Ventilatory Results

acronym: SEQLAR

summary:
Selective laryngeal bilateral reinnervation as a secondary treatment in patients with bilateral vocal fold paralysis, previously treated by endoscopy, without residual arytenoids ankylosis.

The surgical procedure is : functional reinnervation with the upper root of one phrenic nerve, is used for reinnervation of both cricoarytenoid muscles (laryngeal inspiratory muscles), and simultaneous reinnervation of adductor laryngeal muscles is performed by right and left thyro -hyoid nerves (coming from the hypoglossi) on both sides.

Results are obtained after 6 to 9 months delay. In case of good inspiratory arytenoid abduction, and residual dysphonia, a secondary vocal fold medialization is done by an endoscopic approach 12 months after reinnervation (included in the protocol).

Improvement is expected in voice and breathing, without aspiration.


title: Pilot Randomized Double Blind, Placebo Controlled Trial of the Efficacy of Simvastatin for Smoking Cessation

acronym: ADDICSTATINE

summary:
Tobacco smoking is the number one preventable cause of disease worldwide. Unfortunately, there are few smoking cessation agents and their effectiveness has been shown to be relatively limited and is associated with potential unwanted effects. Therefore, the discovery of new medications that can facilitate abstinence and reduce relapse to cigarette use represents a pressing necessity. In the attempt to find molecules that could reduce drug-seeking behavior, we discovered that simvastatin reduces cocaine and nicotine, but not food, seeking behavior in rats. This discovery of a new therapeutic application for an already marketed class of compounds may greatly facilitate the translation from preclinical to clinical setting. In this project, we aim at investigating whether simvastatin is an effective smoking cessation agent in humans.

The study design is a multicenter, randomized, double blind 2 parallel groups, clinical trial with an intention-to-treat analysis. Smokers will randomly be assigned to receive simvastatin or placebo for 3 months. 200 smokers (100 receiving simvastatin and 100 receiving placebo) will be recruited through already established networks of general practitioners. The primary outcome of the efficacy of simvastatin will be the rate of smoking abstinence during the last month of the 3-month treatment period, defined as reported continuous abstinence from smoking and confirmed by expired air carbon monoxide and urinary cotinine concentration. The last assessment will be done 6 months after the predefined quit date.

The results of this proof-of-concept study may open new perspectives in the treatment of tobacco use and dependance.

lead_sponsor: Poitiers University Hospital


title: Follow-up of Oncology Patients After Hospitalization in ICU

acronym: SALTO

summary:
"Purpose: The overall prognosis of oncology patients admitted to intensive care has improved greatly in recent years, leading to a wider admission policy. Due to a decrease in mortality in intensive care, more and more patients returning oncological circuit for the continuation of treatment of the underlying disease The existence of sequelae after the ICU (Intensive Care Unit) stay, whether renal, cardiac, respiratory or other, may influence the continuation of the optimal anti -cancer treatments and thus reduce the chances of recovery or evolution without tumor progression. However, no studies have evaluated the effects of resuscitation on subsequent cancer treatment strategies. It would thus become better appreciate the long-term oncology patients discharged alive from the hospital after a stay in intensive care.

Main purpose of research :

Assess the feasibility of a anti-tumor therapy for patients with progressive solid tumors, after an intensive care stay for other reason than elective surgery monitoring or securing an invasive procedure. The possibility of making an anti -cancer treatment will be evaluated by the treating oncologist and classified total, partial or absent from that defined before or during the ICU stay

Secondary objective of the research :

Evaluate the percentage of patients discharged alive from the ICU and dying in the hospital.

Evaluate survival, lifestyle and physical and psychological effects of these patients after discharge from the hospital over a period of one year. It is understood that all these secondary endpoints will interfere with the existence of an evolutionary neoplasia not only with the ICU stay. They will therefore be interpreted with caution.

Study Type: observational Study Design: Prognostic study of routine care, national, prospective, cohort type "


title: Intérêt du TFP (Transversalis Fascia Plane) Bloc échoguidé Pour l'analgésie du prélèvement Osseux de crête Iliaque

acronym: TFP

summary:
Iliac crest bone graft harvest is associated with acute pain that can lead to chronic postoperative pain. Local anesthetic infiltration and regional anesthesia could be of interest to reduce opioid consumption during and after surgery, reduce hyperalgesia and the associated risk of chronic postoperative pain. In this surgery, local anesthetic infiltration of the iliac crest is associated with a pain reduction compare with placebo.

Some studies have shown the benefit of a TAP (transversus abdominal block) for postoperative analgesia after iliac crest bone graft harvest. The TFP block (transversalis fascia plane block) has been recently described. Considering the nerves trajectories, the TFP block is probably anatomically the most appropriate block for analgesia after iliac crest bone graft harvest.

The aim of this study is therefore to assess the benefit of an ultrasound TFP block for analgesia after iliac crest bone graft harvest compare with local anesthetic infiltration Design is prospective, randomized, double blind, controlled study


title: Analysis of Cerebral Spinal Fluid and Plasma After Aneurysmal Subarachnoid Hemorrhage by Evaluating a Metabolomic Profile and the Proteasic Activity as Biomarkers for Early Detection of Arterial Vasospasm

summary:
The subarachnoid hemorrhage (SAH) from ruptured aneurysm is a situation that is life-threatening, which is largely dependent on the occurrence of vasospasm from the 4th day after the bleeding. This vasopasm is responsible of clinical morbidity in 30 to 50% of patients. It occurs in 40% of patients with severe SAH.

Despite knowing this, the clinician has no biomarker for identifying patients at risk.

The project presented is original and includes a screening method without a priori to identify predictive biomarkers of vasospasm, likely to become therapeutic targets. In secondary objective we will focus on the protease activity of cerebrospinal fluid (CSF) and blood as a biomarker potential of vasoconstriction at the waning of subarachnoid hemorrhage.

This study will take place over a year prospectively. The inclusion of patients will be in the SAR 1 Hospital of Timone. Patients with severe severe SAH by rupture requiring the establishment of an external ventricular derivation (EVD) will be divided into two groups and compared to one group of patients without necessitating a EVD subarachnoid hemorrhage.

Group 1: Patients with vasopasm
Group 2: Patient presenting no vasopasm Detection of vasopasm was defined using a consensual definition. CSF samples (through EVD) and blood will be made upon arrival of the patient in intensive care and then between the 3rd and 4th day.

As the main criterion, we will identify biomarkers of vasospasm in blood and CSF without a priori assumption by metabolomics. Analysis will be by chromatography system coupled to a high resolution mass spectrometer. This method does not justify effective calculation because it is a step of generating hypotheses requiring further biological validation based on the identified targets.

The secondary criteria, we will study in the blood and CSF association between matrix metalloproteinases (MMP) 2 and 9 and the occurrence of vasopasm.

RESULTS: After comparative analysis of groups 1 and 2 in two phases of the study, we will define a metabolic profile that could identify predictive biomarkers vasopasm.

ReferenceCitation: Triglia T, Mezzapesa A, Martin JC, Verdier M, Lagier D, Dufour H, Bruder N, Alessi MC, Velly LJ. Early matrix metalloproteinase-9 concentration in the first 48 h after aneurysmal subarachnoid haemorrhage predicts delayed cerebral ischaemia: An observational study. Eur J Anaesthesiol. 2016 Sep;33(9):662-9. doi: 10.1097/EJA.0000000000000494.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpiital de la TIMONE ASSISTANCE PUBLIQUE HOPITAUX de MARSEILLE


title: Assessment of the Morphological Concordance Between CT and Cone Beam in Sinus Imagery

acronym: COSINUS

summary: This study compares the morphological concordance between CT (computed tomography) and cone beam in sinus on 26 validated items. CT and cone beam is performed on each patient. Performances of these two imagery technics seem to be closed. Nevertheless, the exposure of the ionizing radiations is lower with the cone beam.

intervention_type: Radiation


title: Evaluation of the Clinical and Electrophysiological Responses of the Brainstem in Patients With Alteration of Consciousness in Relation or Not With Sedation: Prognostic Study of Brain Reflexes

acronym: PRORETRO

summary:
Severe diseases in intensive care unit (ICU) patients are associated with a high mortality rate which nevertheless remains difficult to predict. Recently, the abolition of some brainstem reflexes at clinical examination of ICU patients within the first 24 hours after has been shown of prognostic value in ICU patients requiring sedation. Early abolition of the cough reflex was associated with an increase in mortality and that of the oculocephalic reflex was predictive of coma or delirium after sedation has been stopped. A dysfunction of the brainstem may account for these results and be present in other patient subpopulations, particularly those who do not receive iv sedation or the brain injured patients, who were eluded from the previous study. This dysfunction could take place in the muti-organ failure characteristic of the severe ICU patient. On the other hand, a preliminary study performed on somatosensory evoked potentials has shown that a latency of the P14 wave greater than 16 ms between day 1 and day 3 after admission was associated with death at 28 days. The primary goal of this project is to confirm this hypothesis. By studying the clinical and electrophysiological responses of the brainstem in ICU patients, with or without brain injury, with alteration of consciousness in relation or not with sedation. The other objectives are to determine the correlations between neurophysiological clinical neurological, or neuroradiological data with delirium occurrence.

The main objective of this study is to determine, in ICU patients with or without brain injury and with alteration of consciousness in relation or not with sedation, if abolition of the cough reflex at Day 1 after admission is predictive of mortality at 28 days, independent from cause for admission and severity.


title: Therapeutic Effects of Maternal Melatonin Administration on Brain Injury and White Matter Disease in Very Preterm Infants

acronym: PREMELIP

summary:
Neurocognitive sequelae observed in preterm represent a major health problem for which there is no preventive treatment approved to date. These effects are the result of a multifactorial brain damage occurring in developing prenatal and perinatal period. Melatonin, the principal hormone secreted by the pineal gland has neuroprotective properties in various experimental animal models of perinatal brain damage level. This hormone readily crosses the placental barrier, its antenatal administration would have a neuroprotective effect in the case of preventive preterm birth before 28 weeks of amenorrhea.

The objective of this study determine the dose of melatonin administered parenterally in prenatal maternal in preterm labor to reduce brain damage in the white matter detected by diffusion tensor imaging (DTI) with statistical spatial analysis (TBSS) to the theoretical term of 40 weeks in children born prematurely.


title: Prospective Study Evaluating the Clinical Impact of the Breast Cancer Intrinsic Subtype-Prosigna Test (Assay) in the Management of Early-stage Breast Cancers

summary: The primary objective of this study is to evaluate the impact of the result of the Prosigna Test (assay) on the therapeutic decision of adjuvant therapy (chemotherapy and hormone therapy) in patients suffering from early-stage breast cancer.

lead_sponsor: NanoString Technologies, Inc.


title: Full Field Optical Coherence Tomography of Prostate Biopsies for the Diagnosis of Prostate Cancer

summary:
Primary objective :

The primary objective is to evaluate the diagnosis performance of FFOCT for cancer detection in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation.

Secondary objective:

Evaluate predictive values of FFOCT for cancer detection on prostate biopsy cores
Evaluate the value of FFOCT for cancer characterization on prostate biopsy cores
Evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy cores
Evaluate the learning curve of FFOCT evaluation on prostate biopsy cores
Evaluate FFOCT procedure time

location_facility: Assistance Publique - Hôpitaux de Paris Cochin Hospital


type: Other Grant/Funding Number

title: A Randomised Controlled Multicenter Trial Evaluating the Efficacy of Acupuncture Versus Placebo on the Caesarean Section Rate in Case of Cervical Dystocia in Full-term Pregnancy

acronym: ACUCESAR

summary:
The principal objective of the trial is to demonstrate that acupuncture could reduce the caesarean section rate for cervical dystocia.

Secondary objectives:

To demonstrate that acupuncture can:

reduce morbidity, fetal mortality and duration of childbirth;
reduce the cost of care, due to diminution of caesarean sections and duration of obstetric labor;
to evaluate the tolerance.

location_facility: Department of Obstetrics, Hôpital Saint-Cloud


title: Functional MRI Study of the Involvement of Cortico-cerebellar and Cortico-striatal Networks in Children With a Developmental Coordination Disorder (DCD) and/or Developmental Dyslexia (DD)

acronym: FMRI-DCD-DD

summary: All the studies underlined the high frequency of co-morbid associations in specific learning disorders. Understanding the reasons for these associations could enable us to determine the cerebral bases that underlie each disorder. Their frequent association suggests the etiological bases are partly common, it seems logical to turn to explanatory models of various common specific disorders. The model recently proposed by Nicholson & Fawcett (2007) suggests a specific disorder of procedural learning. But the brain networks involved in this learning could be achieved separately. We intend therefore to study the neural networks involved in learning procedural and compare networks recruited among children with specific learning disorder alone or in combination (co-morbidity). The children included in the study have either a Developmental Dyslexia or a Developmental Coordination Disorder, or both. The procedure includes a neuropsychological evaluation and a brain MRI study with a morphological and a functional part. During fMRI the child realizes a automated motor task contrasting with a task involving learning procedural.

primary_purpose: Other

ReferenceCitation: Biotteau M, Péran P, Vayssière N, Tallet J, Albaret JM, Chaix Y. Neural changes associated to procedural learning and automatization process in Developmental Coordination Disorder and/or Developmental Dyslexia. Eur J Paediatr Neurol. 2017 Mar;21(2):286-299. doi: 10.1016/j.ejpn.2016.07.025. Epub 2016 Aug 12.

ReferenceCitation: Biotteau M, Albaret JM, Lelong S, Chaix Y. Neuropsychological status of French children with developmental dyslexia and/or developmental coordination disorder: Are both necessarily worse than one? Child Neuropsychol. 2017 May;23(4):422-441. doi: 10.1080/09297049.2015.1127339. Epub 2016 Jan 4.


title: Activité Physique et prévention de la Chute du Patient âGé hospItalisé en Court séjouR: Etude de faisabilité (AGIR)

acronym: AGIR

summary: This study aims to evaluate the feasibility and the impact on physical performance and falls occurence among geriatric inpatients hospitalized in acute care unit.

ReferenceCitation: Noublanche F, Simon R, Ben-Sadoun G, Annweiler C. Physical Activity and Fall Prevention in Geriatric Inpatients in an Acute Care Unit (AGIR Study): Protocol for a Usability Study. JMIR Res Protoc. 2022 Jul 11;11(7):e32288. doi: 10.2196/32288.

lead_sponsor: University Hospital, Angers


title: Effects of Topical Dynamic Phototherapy (TDP) on the Microbiota of Chronic Wounds: a Pilot Study

acronym: PDT-Bactério

summary: The main objective of this study is to estimate the change in the relative numbers of commensal or low virulence potential bacteria before and after one session TDP.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: THERAPEUTIC PATIENT EDUCATION AND CANCER PAIN

acronym: EFFADOL

summary: Describe the expectations of therapeutic education for patients in management of cancer pain.

lead_sponsor: Centre Francois Baclesse


title: Neural Correlates of Language Control in Bilinguals. Functional MRI and Stimulation Mapping Data in Awake Surgery. (NEUROSWITCH)

acronym: NEUROSWITCH

summary:
For bilingual and multilingual patients, brain activation and Electric Stimulation Mapping studies have shown that different languages may be localized, at least partially, in distinct microanatomical systems located within the same gross anatomical areas.

The present investigation involves both types of healthy bilinguals with carefully controlled proficiency levels, as well as bilingual patients suffering from low-grade glioma.

Functional magnetic resonance imaging data will be collected while the participants perform a picture naming task in blocked conditions for both languages (either English or French) or in switch condition (English and French). A stimulation mapping study will be conducted in the patients during awake surgery with the same tasks.

lead_sponsor: University Hospital, Toulouse


title: Single Arm Phase II Trial Evaluating the Efficacy of Radium 223 in Radioactive Iodine Refractory Bone Metastases From Differentiated Thyroid Cancer

acronym: RAD-THYR

summary:
The purpose of this Phase II single-arm study is to evaluate the efficacy of Radium-223 in treating bone lesions from differentiated thyroid cancer that are I-131 refractory. Based on the results of the phase III trial, the protocol using an injection of Radium-223 activity of 50 kBq/kg b.w. given 6 times at 4 weeks interval will be applied. The end point of this study will be the evaluation of Radium-223 efficacy one month after 3 administrations, i.e. at 3 months after the first injection. If disease progression at that time is excluded, patients will be treated with 3 further injections for a total of 6 administrations of Radium-223. The principal response criterion at 3 and 6 months will be the metabolic response on FDG PET/CT, but other imaging techniques will also be performed: axial skeleton MRI, 99mTc-HMDP bone scan and FNa PET/CT. Axial skeleton MRI is the reference for soft tissue study. 99mTc- HMDP bone scan is the most used and available routine tool to detect bone metastases in cancer patients, but its sensitivity in patients with bone metastases from thyroid cancer is low, because most lesions are lytic [23]. 18FNa PET/CT shows higher sensitivity than 99mTc-HMDP bone scan to detect bone lesions in cancer patients and is able to detect micrometastases that are not seen on bone scan [24] [25]. Preliminary results show some interest of using this tracer to evaluate the sclerotic component of bone metastases from thyroid cancer [26]. Furthermore preliminary data show that FNa PET/CT can be useful to quantify response to Radium-223 in prostate cancer. In only five patients evaluated by FNa PET/CT at baseline, 6 weeks and 12 weeks after 100 KBq/Kg of Radium-223, semiquantitative analysis by SUV max showed a relationship between PSA and SUV max level decrease in 3 patients (-44%, -31%, -27% vs -52%, -75, and -49% respectively) [27].

Finally bone metastases that are visible on morphological imaging (CT scan or on RI) are frequently submitted to local treatment modalities, and this may induce fibrosis and recalcification. Therefore, already treated metastases and not treated metastases will be studied separately as two separate subgroups of target lesions.

ReferenceCitation: Deandreis D, Maillard A, Zerdoud S, Bournaud C, Vija L, Sajous C, Terroir M, Leenhardt L, Schlumberger M, Borget I, Leboulleux S. RADTHYR: an open-label, single-arm, prospective multicenter phase II trial of Radium-223 for the treatment of bone metastases from radioactive iodine refractory differentiated thyroid cancer. Eur J Nucl Med Mol Imaging. 2021 Sep;48(10):3238-3249. doi: 10.1007/s00259-021-05229-y. Epub 2021 Feb 23.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Prenatal Endoscopic Repair of Fetal Spina Bifida

acronym: ENDOSPIN

summary: The purpose of this study is to determine the feasibility of prenatal minimally-invasive fetoscopic closure with i) uterine exteriorization for a minimally-invasive repair under amniotic carbon dioxide insufflation ii) two trocars for the dissection and the cover with one patch or the suture of the skin edges by stitch

ReferenceCitation: Kohl T. Percutaneous minimally invasive fetoscopic surgery for spina bifida aperta. Part I: surgical technique and perioperative outcome. Ultrasound Obstet Gynecol. 2014 Nov;44(5):515-24. doi: 10.1002/uog.13430.

ReferenceCitation: Adzick NS, Thom EA, Spong CY, Brock JW 3rd, Burrows PK, Johnson MP, Howell LJ, Farrell JA, Dabrowiak ME, Sutton LN, Gupta N, Tulipan NB, D'Alton ME, Farmer DL; MOMS Investigators. A randomized trial of prenatal versus postnatal repair of myelomeningocele. N Engl J Med. 2011 Mar 17;364(11):993-1004. doi: 10.1056/NEJMoa1014379. Epub 2011 Feb 9.

ReferenceCitation: Degenhardt J, Schürg R, Winarno A, Oehmke F, Khaleeva A, Kawecki A, Enzensberger C, Tinneberg HR, Faas D, Ehrhardt H, Axt-Fliedner R, Kohl T. Percutaneous minimal-access fetoscopic surgery for spina bifida aperta. Part II: maternal management and outcome. Ultrasound Obstet Gynecol. 2014 Nov;44(5):525-31. doi: 10.1002/uog.13389.

ReferenceCitation: Verbeek RJ, Heep A, Maurits NM, Cremer R, Hoving EW, Brouwer OF, van der Hoeven JH, Sival DA. Fetal endoscopic myelomeningocele closure preserves segmental neurological function. Dev Med Child Neurol. 2012 Jan;54(1):15-22. doi: 10.1111/j.1469-8749.2011.04148.x. Epub 2011 Nov 29. Review.


acronym: KAWAKINRA

title: A Phase IIa Multicenter Trial to Assess the Efficacy, and Safety of Anakinra in Patients With Intravenous Immunoglobulin-resistant Kawasaki Disease

ReferenceCitation: Koné-Paut I, Tellier S, Belot A, Brochard K, Guitton C, Marie I, Meinzer U, Cherqaoui B, Galeotti C, Boukhedouni N, Agostini H, Arditi M, Lambert V, Piedvache C. Phase II Open Label Study of Anakinra in Intravenous Immunoglobulin-Resistant Kawasaki Disease. Arthritis Rheumatol. 2021 Jan;73(1):151-161. doi: 10.1002/art.41481. Epub 2020 Nov 17.

summary: The study is designed to assess the efficacy and safety of anakinra, an interleukin 1 receptor antagonist, in patients with Kawasaki disease who failed to respond to standard treatment:e.g. one infusion of 2g/kg of intravenous immunoglobulins.


title: Internet Addiction and Sleep Disorders

acronym: ADDICSOM

summary: This is an open label randomized controlled trial, comparing two modes of treatment for internet addiction (gaming or gambling online) with sleep disorders associated.

ipd_sharing_description:
At the end of the study, patient could be informed of result of the study if they wish.

No individual result will be communicate.

intervention_type: Behavioral


title: Prospective Cohort Assessing the Role of the Genotoxin Colibactin From Escherichia Coli B2 in the Genesis of NASH

acronym: Coli-NASH

summary:
In a population of patients with Non Alcoholic Fatty Liver Disease (NAFLD), the investigators will compare the composition of the gut microbiota from patients with simple steatosis with that with steatohepatitis.

The purpose of this study is to determine if the pathogenic Escherichia Coli to the B2 group and producing the genotoxin colibactin is a factor for developing NASH.

ReferenceCitation: Smati S, Polizzi A, Fougerat A, Ellero-Simatos S, Blum Y, Lippi Y, Régnier M, Laroyenne A, Huillet M, Arif M, Zhang C, Lasserre F, Marrot A, Al Saati T, Wan J, Sommer C, Naylies C, Batut A, Lukowicz C, Fougeray T, Tramunt B, Dubot P, Smith L, Bertrand-Michel J, Hennuyer N, Pradere JP, Staels B, Burcelin R, Lenfant F, Arnal JF, Levade T, Gamet-Payrastre L, Lagarrigue S, Loiseau N, Lotersztajn S, Postic C, Wahli W, Bureau C, Guillaume M, Mardinoglu A, Montagner A, Gourdy P, Guillou H. Integrative study of diet-induced mouse models of NAFLD identifies PPARα as a sexually dimorphic drug target. Gut. 2022 Apr;71(4):807-821. doi: 10.1136/gutjnl-2020-323323. Epub 2021 Apr 26.

intervention_type: Biological


title: Optically Pumped 4He Magnetometers Performances Compared With Medical Reference Methods : Electrocardiography (ECG) and Magnetoencephalography (MEG)

acronym: MINIMAG

summary: Optically Pumped 4He Magnetometers operability for cerebral and cardiac magnetic fields measurement.

lead_sponsor: University Hospital, Grenoble


title: " Anemil Trial ": Phase I/II Clinical Trial Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment

acronym: ANEMIL

summary: The investigators have demonstrated that the mean percentage of circulating CD8+ regulatory T (CD8 Tregs) cells is significantly higher in patients with warm hemolytic anemia (wAHAI) in remission than in controls and is correlated to hemoglobin levels. In vitro, low dose of interleukine-2 (IL2) induce the expansion of CD8 Tregs. The objective is to demonstrate that, over a 9 week treatment period; low doses of IL2 can induce the expansion of CD8Tregs in patients with active wAHAI.

lead_sponsor: University Hospital, Bordeaux


title: Reduction de la Morbi-mortalité Cardiovasculaire Chez l'artériopathe Claudicant Par le Sildenafil

summary: Sildenafil has shown potential effects both on vasodilator mechanisms and as an inhibitor of the NO/GMPc Pain activation. The investigators aim at estimating the benefit of sildenafil in term of morbi-mortality in patients with arterial claudication on a multicenter prospective double blind study.


title: A Phase I Trial Assessing Several Schedules of Oral S-1 in Combination With a Fixed Dose of Oxaliplatin and Irinotecan in Patients With Advanced or Metastatic Digestive Adenocarcinoma as First- or Second-line Treatment

acronym: SIRINOX

summary: This study is to determine the Maximal Tolerated Dose (MTD), the Dose Limitant Toxicities (DLTs) and the safety profile of S-1 combined with fixed doses of Irinotecan (SIRI schedule) and fixed doses of Irinotecan and Oxaliplatin (SIRINOX schedule).

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


title: Screening for Phobia of Falling in the Elderly: Validity and Feasibility of a Self-administered Questionnaire

acronym: PACTE-q

summary: The aim of this study is to determine the validity of a self-questionnaire detecting seniors phobia of falling living at home. A prospective monocentric observational study compares in a blind way the presence of Diagnostic and Statistical Manual of Mental Disorders fourth edition (DSM-IV) criteria for specific phobia, considered as the gold standard to the score obtained at the detecting questionnaire for ≥70 years old seniors suspected of phobia of falling and attending geriatric day hospital at the Bretonneau hospital (APHP, Paris).

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Long-term Efficacy of Repetitive Transcranial Magnetic Stimulation on the Primary Motor Cortex (M1) in Central Neuropathic Pain

summary: The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Ultrasound Assessment of Gastric Content for Semi Emergency Surgery

acronym: ECHO-GAST

summary: Aspiration of gastric content is a rare but serious complication of anesthesia. In this context, preoperative fasting for elective surgery is well defined. In an emergency situation, international guidelines recommend rapid sequence of anesthesia to reduce the risk of aspiration. In semi emergency situation, there is no consensus about the anesthetic procedure even if a preoperative fasting has been observed due to uncertainty of gastric emptying related to stress or painful condition. The choice of anesthesia induction technique depends mainly on the anesthetist. Ultrasonography is a non invasive bedside tool that can provide reliable quantitative information about the volume of gastric content.


title: Study Evaluating the Utility of 18F-FDG PET in Assessing Early Response to Neoadjuvant Treatment in Patients With Mammary Gland Cancer

acronym: TREN

summary:
Neoadjuvant chemotherapy is frequently proposed to patients with mammary gland cancer. The aim is to reduce tumor volume before surgical therapy. Obtaining a pathologic Complete Response (pCR) is regarded as a good prognostic factor with less risk of recurrence. The rate of pCR is about 20%, although there are important variations according to tumor subtype and the type of treatment. The objective of the new therapeutic strategies is to increase this response rate.

The purpose of this study is to investigate the possibility of early evaluation of neoadjuvant chemotherapy response after one cycle of neoadjuvant chemotherapy by positron emission tomography (PET) with (18) F-fluorodeoxyglucose (FDG) in patients.

status: Recruiting

lead_sponsor: Centre Georges Francois Leclerc

status_simplified: Ongoing


title: Activity of Regorafenib in Combination With Modified Gemcitabine - Oxaliplatin Chemotherapy (mGEMOX) in Patients With Advanced Biliary Tract Cancer (BTC): A Phase Ib-II Trial (BREGO)

acronym: BREGO

summary: This study is to determine the Regorafenib Dose (RD) for the phase II trial of Regorafenib administered in combination with mGEMOX in patients with advanced biliary tract cancer.


acronym: Flammacérium

summary: Ischemia of an area may lead to a necrotic wound. In lower limb, it especially happens in diabetic or artheriopatic patients. It can lead to an amputation need. Revascularization procedure cannot be provide in all cases. Flammacerium, by a crust training and its anti-inflammatory effect, could stabilize necrosis extension, avoid bacterial contamination and then improve some incapacitating symptoms like odor or pain. This product may allow to delay amputation ruling for patients on who this procedure is unsafe. During 6 months, the investigators evaluate Flammacerium against standard dressing procedure in necrotic wound of the lower limb in patients where no revascularization can be provide. The investigators observed its effect on amputation need, symptoms as pain, infection, wound aspect evolution, wound size decrease.

lead_sponsor: University Hospital, Montpellier


title: Thromboelastographic Profile During Simultaneous Pancreas-kidney Transplantation

acronym: TEG-PKT

summary:
Type of study:Prospective, single-center, non-therapeutic, of routine care No randomization, no modifications of the usual care, study results are not available for the physicians in charge of the patient.

Objectives:

The main objective of this study is to evaluate the ability of the thromboelastogram (ROTEM®) to detect clotting disorders related to pancreas-kidney transplantation, comparing ROTEM ® profiles during the perioperative period of two different types of transplantation (kidney alone and simultaneous pancreas-kidney)

The secondary objectives are:

To assess the incidence and type of coagulation disorders during the perioperative period of these two types of transplantation
To study correlation values between thrombolelastogram and standard coagulation parameters

Population study:

Evaluated group: 40 pancreas-kidney recipients
Control group: 80 kidney recipients
Recruitment periods: 24 months
Patient Monitoring: 48 hours
Total duration of the study: 36 months.
Ethics: Study of routine care. Oral and written information given to patients. Validation of the study protocol by the local ethics committee (CPP Sud Est II: Protocol No. HCL / P 2012.727)

lead_sponsor: Hospices Civils de Lyon

location_facility: Anesthesiology and Critical Care Medicine, Edouard Herriot Hospital, Hospices Civils de Lyon


title: Phase II Trial Assessing the Efficacy of a Reduced Dose Strategy of Darunavir to 400 mg/d in HIV-1 Infected Patients Virologically Suppressed Under a Once Daily Regimen Including Darunavir 800 mg/d and Two Nucleoside Reverse Transcriptase Inhibitors (NRTI), to Maintain the Viral Load Lower Than 50 Copies / mL at 48 Weeks of Treatment

acronym: DARULIGHT

summary: Phase II trial assessing the efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain the viral load lower than 50 copies / mL at 48 weeks of treatment.

ReferenceCitation: Lê MP, Chaix ML, Chevret S, Bertrand J, Raffi F, Gallien S, El Abbassi EMB, Katlama C, Delobel P, Yazdanpanah Y, Saillard J, Molina JM, Peytavin G; ANRS 165 DARULIGHT Study Group. Pharmacokinetic modelling of darunavir/ritonavir dose reduction (800/100 to 400/100 mg once daily) in a darunavir/ritonavir-containing regimen in virologically suppressed HIV-infected patients: ANRS 165 DARULIGHT sub-study. J Antimicrob Chemother. 2018 Aug 1;73(8):2120-2128. doi: 10.1093/jac/dky193.

lead_sponsor: ANRS, Emerging Infectious Diseases


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

acronym: MANOE

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


title: Characterization of Obesity-related Cardiomyopathy Through Exploration of Human Atrial Trabeculae Contraction

summary: The investigators aim to explore obese cardiomyopathy by studying contractile twitch force, sarcomere sensitivity to calcium and mitochondrial function in atrial myocardial samples of patients grouped according to their body mass index, i.e. normal weight, overweight and obese.

lead_sponsor: University Hospital, Lille


title: Study of Metabolic Modifications in Children With Noonan Syndrome

acronym: MetabNoonan

summary: Noonan syndrome (NS) is a rare genetic disease (incidence 1/2500 live births) characterized by the association of craniofacial manifestations, cardiopathies, short stature, and tumor predisposition. The genetic causes of Noonan Syndrome are mutations of genes involved in the Ras/Mitogen-Activated Protein Kinases (MAPK) pathway, mainly the gene encoding the tyrosine phosphatase Shp2 (50% of patients).Shp2 appears to be involved in many facets of energy metabolism control (glucose homeostasis, adipose tissue function…), through mechanisms that are poorly understood. Several metabolic anomalies (reduced adiposity, improved glucose tolerance) have been recently identified in an original mouse model carrying Shp2 mutation. Moreover, recent clinical survey has shown that adult Noonan Syndrome patients are protected from developping overweight and obesity when compared to the general population. However, the metabolic status associated with Noonan Syndrome condition has not been explored to date.

ReferenceCitation: Tartaglia M, Gelb BD, Zenker M. Noonan syndrome and clinically related disorders. Best Pract Res Clin Endocrinol Metab. 2011 Feb;25(1):161-79. doi: 10.1016/j.beem.2010.09.002. Review.

ReferenceCitation: Tidyman WE, Rauen KA. The RASopathies: developmental syndromes of Ras/MAPK pathway dysregulation. Curr Opin Genet Dev. 2009 Jun;19(3):230-6. doi: 10.1016/j.gde.2009.04.001. Epub 2009 May 19. Review.

ReferenceCitation: Montagner A, Yart A, Dance M, Perret B, Salles JP, Raynal P. A novel role for Gab1 and SHP2 in epidermal growth factor-induced Ras activation. J Biol Chem. 2005 Feb 18;280(7):5350-60. Epub 2004 Dec 1.

ReferenceCitation: Yart A, Laffargue M, Mayeux P, Chretien S, Peres C, Tonks N, Roche S, Payrastre B, Chap H, Raynal P. A critical role for phosphoinositide 3-kinase upstream of Gab1 and SHP2 in the activation of ras and mitogen-activated protein kinases by epidermal growth factor. J Biol Chem. 2001 Mar 23;276(12):8856-64. Epub 2000 Dec 27.

ReferenceCitation: Zhang SQ, Tsiaras WG, Araki T, Wen G, Minichiello L, Klein R, Neel BG. Receptor-specific regulation of phosphatidylinositol 3'-kinase activation by the protein tyrosine phosphatase Shp2. Mol Cell Biol. 2002 Jun;22(12):4062-72.


title: A Prospective, Randomized and Controlled Study Estimating the Neurally Adjusted Ventilatory Assist (NAVA) Versus the Pressure Support Ventilatory (PSV) in Difficult Weaning From Mechanical Ventilation

acronym: SENA

summary: The NAVA, by its more physiological aspect and a better adaptation of the patient to the ventilator with a decrease of asynchronies patients-ventilators, could decrease the duration of weaning and so decrease the duration of invasive mechanical ventilation and the morbi-mortality. The objective of this study is to compare the neurally adjusted ventilatory assist versus the usual management of weaning from mechanical ventilation, in term of duration of weaning, at the patients in period of difficult weaning from the invasive mechanical ventilation.

primary_purpose: Supportive Care


acronym: DysA

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

location_facility: Hôpital Louis Pradel - service de pneumologie


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

acronym: PETANC

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


title: Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial

summary:
Objective : To assess the analgesic effect of maternal breast milk odor in preterm neonates Design : A prospective, randomised, controlled, double blinded, monocentric trial.

Méthods : The neonates were included from 01/01/2012 to 31/12/2014. Inclusion criteria were: neonates fed with their mother breast milk, gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days, a postnatal age ≤ 10 days and a birth weight greater than the 5th percentile according to Olsen curves et al. They also had to be: clinically stable, with 48 hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease. The two legal representatives must have signed an informed consent. The study excluded the neonates for whom no video was recorded during the venipuncture.

In the first group "breast milk", venipuncture was performed to the neonate while his mother's milk odor was being diffused. In a second control group, the same gesture was made with an odorless diffusor. The primary outcome was the clinical score assessment PIPP (Premature Infant Pain Profile). The secondary outcomes were the DAN score (Acute Pain of Newborn) and the salivary cortisol level.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique des Hopitaux de Marseille


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

acronym: Echo-TC

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

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

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

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

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

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

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

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

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

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

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

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

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

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


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

acronym: PEPs PROSTATE

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

This study is carried out in two steps :

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

lead_sponsor: Institut de Cancérologie de la Loire


title: SIMulation for HEmofiltration in Intensive caRe Unit

acronym: SIMHeR

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

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

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

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

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

lead_sponsor: University Hospital, Angers


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

acronym: SCHIZOBAT

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

lead_sponsor: Centre Hospitalier St Anne