title: Study of the Efficiency of the Ketamine With Low Analgesic Doses, in Association With High Opioids, in the Treatment of the Rebels Pains, in Palliative Phase of the Cancerous Disease

acronym: KEPAL

summary: Long-term opioid therapy is commonly administered for the management of severe cancer pain. Increasing doses of opioids are titrated against effects until analgesia is achieved or intolerable adverse effects occur. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has been reported to improve analgesia in patients with uncontrolled pain receiving high doses of opioids. This study aims at determining the effectiveness of ketamine as an adjuvant to opioids in relieving cancer pain.

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location_facility: Center of Evaluation and Treatment of the pain - Saint-Antoine Hospital


title: A Phase II, Open Label Clinical Trial Exploring the Safety and the Efficacy of Oral Deferasirox in Patients Newly Diagnosed With Porphyria Cutanea Tarda (PCT) and Non-transfusion Iron Overload

summary: While clinical phlebotomy is current standard practice for alleviating non-transfusion iron overload in patients with PCT, it may not be suitable for all patients. For example, some patients are unwilling to be adequately phlebotomized because of inconvenience, as phlebotomy can be cumbersome, especially during the induction treatment phase requiring frequent clinic visits (twice a month, for at least 6 months) or because of venous access difficulties. Other patients are unable to undergo phlebotomy due to medical reasons such as anemia or cardiopulmonary disorders. It is postulated such patients with PCT who have non-transfusion iron overload could benefit from treatment with deferasirox (Exjade®), a once daily oral iron chelator licensed in several countries, including the EU, for treating transfusion iron overload in adult and pediatric patients. Although there is some data on the efficacy and safety of deferasirox in patients with HH, who, like those with PCT, have non-transfusional iron overload, there is a need to evaluate the safety and efficacy of deferasirox treatment of non-transfusion iron overload in patients with PCT.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: result

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: Association pour l'Etude des Fonctions Digestives (AEFD)

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


title: Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening? A Cluster Randomised Controlled Study.

summary: The propose of this study is to assess the effect of general practitioner's involvement in the stimulus invitation letter in colorectal cancer screening compared to sending the patient home test (stimulus 2 of reference as contained in the specifications).

design_allocation: Randomized

primary_purpose: Screening

lead_sponsor: University of Paris 5 - Rene Descartes

collaborators: Société de Formation Thérapeutique du Généraliste

intervention_type: Other


summary: The propose of this study is to assess the effect of general practitioner's involvement on first patients' solicitation in screening for colorectal cancer by testing for faecal occult blood (FOBT).

sponsor_collaborators: Société de Formation Thérapeutique du Généraliste


type: Other Identifier

title: Evaluation of Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Critically Ill Children

acronym: Incat

summary: Removal of a central venous catheter (CVC) is often useful to prove its responsibility in a bloodstream infection. To avoid unnecessary removal of CVC, some catheter-spearing diagnostic methods have been recently developed. The aim of the study is to evaluate three catheter-spearing diagnostic methods in critically ill children: 1) the measurement of the differential time to positivity between a blood culture drawn from a peripherical vein and another one drawn through the CVC; 2) the exam of a blood sample drawn for the CVC and stained by acridine orange leucocyte cytospin test; 3) the semi-quantitative skin culture of the area around the insertion site of the CVC.

status: Completed

study_completion_date_type: Actual

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Actual

status_simplified: Completed


title: Structural Spinal Cord Integrity in Patients With Cervical Spondylosis in Relation to Clinical Status

acronym: Tractocervical

summary: This study aims at evaluating spinal cord structure using diffusion tensor imaging in patients with cervical spondylosis.

intervention_type: Device


title: Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma?

acronym: NOnourisson

summary:
Background:

It seems that in the infants and the young children, the increase of the Exhaled Nitric Oxide (eNO) is in connection with: (1) the risk of developing respiratory symptoms; (2) the risk of family and personal atopy; (3) the intensity of the respiratory symptoms; (4) the risk of passage of recurrent wheezing to asthma; (5) and contrary to the fact that the investigators noticed at the child's a positive relation with the environmental tobacco smoke

Objective: the investigators objective is to bring to light that the rise of the eNO, a non invasive biomarker of the bronchial inflammation, would be a risk factor expected from passage of recurrent wheezing of the infant and the young child (of less than 36 months old) towards the asthma of the child.Methods: Once the diagnosis of recurrent wheezing established, the investigators estimate by questionnaire the severity of the asthma, the personal and familial atopy, the collection of the environmental data. After allergic exploration (skin tests and assay of serum total and specific IgE, complete blood count), the eNO is measured by an off-line tidal breathing method using a chemiluminescence NO analyzer. Annually, a questionnaire will be send to families to appreciate the persistence or the remission of the asthma. After a simple descriptive analysis of the population and a multifactorial descriptive analysis, the investigators shall look for the connections between the rise of the eNO and the various clinical, biological and environmental parameters known to influence the variations of this marker. Then the investigators shall select a set of explanatory variables for a multivariate analysis by a logistic regression step by step.

ReferenceType: background

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ReferenceCitation: Barreto M, Villa MP, Martella S, Ronchetti F, Darder MT, Falasca C, Pagani J, Massa F, Ronchetti R. Exhaled nitric oxide in asthmatic and non-asthmatic children: influence of type of allergen sensitization and exposure to tobacco smoke. Pediatr Allergy Immunol. 2001 Oct;12(5):247-56. doi: 10.1034/j.1399-3038.2001.00041.x.

ReferenceCitation: Warke TJ, Fitch PS, Brown V, Taylor R, Lyons JD, Ennis M, Shields MD. Exhaled nitric oxide correlates with airway eosinophils in childhood asthma. Thorax. 2002 May;57(5):383-7. doi: 10.1136/thorax.57.5.383.

ReferenceCitation: Bratton DL, Lanz MJ, Miyazawa N, White CW, Silkoff PE. Exhaled nitric oxide before and after montelukast sodium therapy in school-age children with chronic asthma: a preliminary study. Pediatr Pulmonol. 1999 Dec;28(6):402-7. doi: 10.1002/(sici)1099-0496(199912)28:63.0.co;2-v.

ReferenceCitation: Di Rosa M, Radomski M, Carnuccio R, Moncada S. Glucocorticoids inhibit the induction of nitric oxide synthase in macrophages. Biochem Biophys Res Commun. 1990 Nov 15;172(3):1246-52. doi: 10.1016/0006-291x(90)91583-e.

ReferenceCitation: Malmberg LP, Pelkonen AS, Haahtela T, Turpeinen M. Exhaled nitric oxide rather than lung function distinguishes preschool children with probable asthma. Thorax. 2003 Jun;58(6):494-9. doi: 10.1136/thorax.58.6.494.

ReferenceCitation: Nathan C, Xie QW. Nitric oxide synthases: roles, tolls, and controls. Cell. 1994 Sep 23;78(6):915-8. doi: 10.1016/0092-8674(94)90266-6. No abstract available.

ReferenceCitation: Thomas NS, Wilkinson J, Holgate ST. The candidate region approach to the genetics of asthma and allergy. Am J Respir Crit Care Med. 1997 Oct;156(4 Pt 2):S144-51. doi: 10.1164/ajrccm.156.4.12-tac-13.

ReferenceCitation: Grasemann H, Yandava CN, Drazen JM. Neuronal NO synthase (NOS1) is a major candidate gene for asthma. Clin Exp Allergy. 1999 Dec;29 Suppl 4:39-41.

ReferenceCitation: Grasemann H, Yandava CN, Storm van's Gravesande K, Deykin A, Pillari A, Ma J, Sonna LA, Lilly C, Stampfer MJ, Israel E, Silverman EK, Drazen JM. A neuronal NO synthase (NOS1) gene polymorphism is associated with asthma. Biochem Biophys Res Commun. 2000 Jun 7;272(2):391-4. doi: 10.1006/bbrc.2000.2794.

ReferenceCitation: Wechsler ME, Grasemann H, Deykin A, Silverman EK, Yandava CN, Israel E, Wand M, Drazen JM. Exhaled nitric oxide in patients with asthma: association with NOS1 genotype. Am J Respir Crit Care Med. 2000 Dec;162(6):2043-7. doi: 10.1164/ajrccm.162.6.2003089.

ReferenceCitation: Holla LI, Schuller M, Buckova D, Vacha J. Neuronal nitric oxide synthase gene polymorphism and IgE-mediated allergy in the Central European population. Allergy. 2004 May;59(5):548-52. doi: 10.1111/j.1398-9995.2004.00458.x.

ReferenceCitation: Leung TF, Liu EK, Tang NL, Ko FW, Li CY, Lam CW, Wong GW. Nitric oxide synthase polymorphisms and asthma phenotypes in Chinese children. Clin Exp Allergy. 2005 Oct;35(10):1288-94. doi: 10.1111/j.1365-2222.2005.02342.x.

ReferenceCitation: Lee YC, Cheon KT, Lee HB, Kim W, Rhee YK, Kim DS. Gene polymorphisms of endothelial nitric oxide synthase and angiotensin-converting enzyme in patients with asthma. Allergy. 2000 Oct;55(10):959-63. doi: 10.1034/j.1398-9995.2000.00724.x.

ReferenceCitation: Holla LI, Buckova D, Kuhrova V, Stejskalova A, Francova H, Znojil V, Vacha J. Prevalence of endothelial nitric oxide synthase gene polymorphisms in patients with atopic asthma. Clin Exp Allergy. 2002 Aug;32(8):1193-8. doi: 10.1046/j.1365-2745.2002.01445.x.

ReferenceCitation: Dizier MH, Besse-Schmittler C, Guilloud-Bataille M, Annesi-Maesano I, Boussaha M, Bousquet J, Charpin D, Degioanni A, Gormand F, Grimfeld A, Hochez J, Hyne G, Lockhart A, Luillier-Lacombe M, Matran R, Meunier F, Neukirch F, Pacheco Y, Parent V, Paty E, Pin I, Pison C, Scheinmann P, Thobie N, Vervloet D, Kauffmann F, Feingold J, Lathrop M, Demenais F. Genome screen for asthma and related phenotypes in the French EGEA study. Am J Respir Crit Care Med. 2000 Nov;162(5):1812-8. doi: 10.1164/ajrccm.162.5.2002113.

ReferenceCitation: Xu W, Liu L, Emson PC, Harrington CR, Charles IG. Evolution of a homopurine-homopyrimidine pentanucleotide repeat sequence upstream of the human inducible nitric oxide synthase gene. Gene. 1997 Dec 19;204(1-2):165-70. doi: 10.1016/s0378-1119(97)00538-6.

ReferenceCitation: Warpeha KM, Xu W, Liu L, Charles IG, Patterson CC, Ah-Fat F, Harding S, Hart PM, Chakravarthy U, Hughes AE. Genotyping and functional analysis of a polymorphic (CCTTT)(n) repeat of NOS2A in diabetic retinopathy. FASEB J. 1999 Oct;13(13):1825-32. doi: 10.1096/fasebj.13.13.1825.

ReferenceCitation: Wildhaber JH, Hall GL, Stick SM. Measurements of exhaled nitric oxide with the single-breath technique and positive expiratory pressure in infants. Am J Respir Crit Care Med. 1999 Jan;159(1):74-8. doi: 10.1164/ajrccm.159.1.9805021.

ReferenceCitation: Lundberg JO, Weitzberg E, Lundberg JM, Alving K. Nitric oxide in exhaled air. Eur Respir J. 1996 Dec;9(12):2671-80. doi: 10.1183/09031936.96.09122671.

ReferenceCitation: George SC, Hogman M, Permutt S, Silkoff PE. Modeling pulmonary nitric oxide exchange. J Appl Physiol (1985). 2004 Mar;96(3):831-9. doi: 10.1152/japplphysiol.00950.2003.

ReferenceCitation: Hamouda S, Chevalier-Bidaud B, Aboutaam R, Le Bourgeois M, Scheinmann P, Delclaux C, Mahut B. [Off-line exhaled nitric oxide measurement in children]. Rev Mal Respir. 2006 Nov;23(5 Pt 1):421-5. doi: 10.1016/s0761-8425(06)71811-3. French.

ReferenceCitation: Mahut B, Louis B, Delclaux C. [Measurement of exhaled nitric oxide: methodology]. Rev Mal Respir. 2006 Jun;23(3 Suppl):6S29-6S36. French.

ReferenceCitation: Paredi P, Loukides S, Ward S, Cramer D, Spicer M, Kharitonov SA, Barnes PJ. Exhalation flow and pressure-controlled reservoir collection of exhaled nitric oxide for remote and delayed analysis. Thorax. 1998 Sep;53(9):775-9. doi: 10.1136/thx.53.9.775.

ReferenceCitation: Jobsis Q, Raatgeep HC, Hop WC, de Jongste JC. Controlled low flow off line sampling of exhaled nitric oxide in children. Thorax. 2001 Apr;56(4):285-9. doi: 10.1136/thorax.56.4.285.

ReferenceCitation: Hall GL, Reinmann B, Wildhaber JH, Frey U. Tidal exhaled nitric oxide in healthy, unsedated newborn infants with prenatal tobacco exposure. J Appl Physiol (1985). 2002 Jan;92(1):59-66. doi: 10.1152/jappl.2002.92.1.59.

ReferenceCitation: Gabriele C, van der Wiel EC, Nieuwhof EM, Moll HA, Merkus PJ, de Jongste JC. Methodological aspects of exhaled nitric oxide measurements in infants. Pediatr Allergy Immunol. 2007 Feb;18(1):36-41. doi: 10.1111/j.1399-3038.2006.00472.x.

ReferenceCitation: Tabachnik E, Levison H. Postgraduate course presentation. Infantile bronchial asthma. J Allergy Clin Immunol. 1981 May;67(5):339-47. doi: 10.1016/0091-6749(81)90077-4.

ReferenceCitation: Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC. The International Study of Asthma and Allergies in Childhood (ISAAC) Steering Committee. Lancet. 1998 Apr 25;351(9111):1225-32.

ReferenceCitation: Kauffmann F, Annesi-Maesano I, Liard R, Paty E, Faraldo B, Neukirch F, Dizier MH. [Construction and validation of a respiratory epidemiological questionnaire]. Rev Mal Respir. 2002 Jun;19(3):323-33. French.

ReferenceCitation: Annesi-Maesano I, Didier A, Klossek M, Chanal I, Moreau D, Bousquet J. The score for allergic rhinitis (SFAR): a simple and valid assessment method in population studies. Allergy. 2002 Feb;57(2):107-14. doi: 10.1034/j.1398-9995.2002.1o3170.x.

ReferenceCitation: Azevedo I, de Blic J, Scheinmann P, Vargaftig BB, Bachelet M. Enhanced arachidonic acid metabolism in alveolar macrophages from wheezy infants. Modulation by dexamethasone. Am J Respir Crit Care Med. 1995 Oct;152(4 Pt 1):1208-14. doi: 10.1164/ajrccm.152.4.7551372.

location_facility: Service of multidisciplinary paediatrics (Armand-Trousseau Hospital)


title: Identification and Characterization of the Methylation Abnormalities on Whole Genome Among Infertile Men

acronym: METHYLHOMME

summary: This study will analyse the sperm global methylation status of 62 infertile men before assisted reproductive techniques. Some of these patients (20%) present hypomethylation of H19 locus. A global methylation analysis may reveal others imprinting defects.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Adami HO, Bergstrom R, Mohner M, Zatonski W, Storm H, Ekbom A, Tretli S, Teppo L, Ziegler H, Rahu M, et al. Testicular cancer in nine northern European countries. Int J Cancer. 1994 Oct 1;59(1):33-8. doi: 10.1002/ijc.2910590108.

ReferenceCitation: Anway MD, Cupp AS, Uzumcu M, Skinner MK. Epigenetic transgenerational actions of endocrine disruptors and male fertility. Science. 2005 Jun 3;308(5727):1466-9. doi: 10.1126/science.1108190. Erratum In: Science. 2010 May 7;328(5979):690.

ReferenceCitation: Auger J, Kunstmann JM, Czyglik F, Jouannet P. Decline in semen quality among fertile men in Paris during the past 20 years. N Engl J Med. 1995 Feb 2;332(5):281-5. doi: 10.1056/NEJM199502023320501.

ReferenceCitation: Carlsen E, Giwercman A, Keiding N, Skakkebaek NE. Evidence for decreasing quality of semen during past 50 years. BMJ. 1992 Sep 12;305(6854):609-13. doi: 10.1136/bmj.305.6854.609.

ReferenceCitation: Davis TL, Yang GJ, McCarrey JR, Bartolomei MS. The H19 methylation imprint is erased and re-established differentially on the parental alleles during male germ cell development. Hum Mol Genet. 2000 Nov 22;9(19):2885-94. doi: 10.1093/hmg/9.19.2885.

ReferenceCitation: Gicquel C, Gaston V, Mandelbaum J, Siffroi JP, Flahault A, Le Bouc Y. In vitro fertilization may increase the risk of Beckwith-Wiedemann syndrome related to the abnormal imprinting of the KCN1OT gene. Am J Hum Genet. 2003 May;72(5):1338-41. doi: 10.1086/374824. No abstract available.

ReferenceCitation: Hartmann S, Bergmann M, Bohle RM, Weidner W, Steger K. Genetic imprinting during impaired spermatogenesis. Mol Hum Reprod. 2006 Jun;12(6):407-11. doi: 10.1093/molehr/gal040. Epub 2006 Apr 11.

ReferenceCitation: Kaiser J. Developmental biology. Endocrine disrupters trigger fertility problems in multiple generations. Science. 2005 Jun 3;308(5727):1391-2. doi: 10.1126/science.308.5727.1391a. No abstract available.

ReferenceCitation: Kobayashi H, Sato A, Otsu E, Hiura H, Tomatsu C, Utsunomiya T, Sasaki H, Yaegashi N, Arima T. Aberrant DNA methylation of imprinted loci in sperm from oligospermic patients. Hum Mol Genet. 2007 Nov 1;16(21):2542-51. doi: 10.1093/hmg/ddm187. Epub 2007 Jul 17.

ReferenceCitation: Paulozzi LJ, Erickson JD, Jackson RJ. Hypospadias trends in two US surveillance systems. Pediatrics. 1997 Nov;100(5):831-4. doi: 10.1542/peds.100.5.831.

ReferenceCitation: Preiksa RT, Zilaitiene B, Matulevicius V, Skakkebaek NE, Petersen JH, Jorgensen N, Toppari J. Higher than expected prevalence of congenital cryptorchidism in Lithuania: a study of 1204 boys at birth and 1 year follow-up. Hum Reprod. 2005 Jul;20(7):1928-32. doi: 10.1093/humrep/deh887. Epub 2005 Apr 28.

ReferenceCitation: Skakkebaek NE, Rajpert-De Meyts E, Main KM. Testicular dysgenesis syndrome: an increasingly common developmental disorder with environmental aspects. Hum Reprod. 2001 May;16(5):972-8. doi: 10.1093/humrep/16.5.972.

ReferenceCitation: Toppari J, Larsen JC, Christiansen P, Giwercman A, Grandjean P, Guillette LJ Jr, Jegou B, Jensen TK, Jouannet P, Keiding N, Leffers H, McLachlan JA, Meyer O, Muller J, Rajpert-De Meyts E, Scheike T, Sharpe R, Sumpter J, Skakkebaek NE. Male reproductive health and environmental xenoestrogens. Environ Health Perspect. 1996 Aug;104 Suppl 4(Suppl 4):741-803. doi: 10.1289/ehp.96104s4741.

location_facility: Department of Biology of reproduction (TENON Hospital)


title: Reliving the Traumatic Event in Posttraumatic Stress Disorder: An Emotional Memory Reactivation Pathology? An fMRI Study

acronym: VIVITRAU

summary:
Converging lines of evidence have implicated the amygdala in the pathophysiology of posttraumatic stress disorder.

The primary purpose of our study is to assess the effect of propanolol, a beta adrenergic antagonism, on amygdala activation during a symptom provocation state in traumatized subjects with and without posttraumatic stress disorder.

status: Terminated

ReferenceCitation: Adler SA, Wilk A, Rovee-Collier C. Reinstatement versus reactivation effects on active memory in infants. J Exp Child Psychol. 2000 Feb;75(2):93-115. doi: 10.1006/jecp.1999.2531.

ReferenceCitation: Blanchard EB, Hickling EJ, Taylor AE, Forneris CA, Loos W, Jaccard J. Effects of varying scoring rules of the Clinician-Administered PTSD Scale (CAPS) for the diagnosis of post-traumatic stress disorder in motor vehicle accident victims. Behav Res Ther. 1995 May;33(4):471-5. doi: 10.1016/0005-7967(94)00064-q.

ReferenceCitation: Botreau F, El Massioui N, Cheruel F, Gisquet-Verrier P. Effects of medial prefrontal cortex and dorsal striatum lesions on retrieval processes in rats. Neuroscience. 2004;129(3):539-53. doi: 10.1016/j.neuroscience.2004.08.032.

ReferenceCitation: Boujabit M, Bontempi B, Destrade C, Gisquet-Verrier P. Exposure to a retrieval cue in rats induces changes in regional brain glucose metabolism in the amygdala and other related brain structures. Neurobiol Learn Mem. 2003 Jan;79(1):57-71. doi: 10.1016/s1074-7427(02)00010-2.

ReferenceCitation: Brunet A, Orr SP, Tremblay J, Robertson K, Nader K, Pitman RK. Effect of post-retrieval propranolol on psychophysiologic responding during subsequent script-driven traumatic imagery in post-traumatic stress disorder. J Psychiatr Res. 2008 May;42(6):503-6. doi: 10.1016/j.jpsychires.2007.05.006. Epub 2007 Jun 22.

ReferenceCitation: Dirikx T, Hermans D, Vansteenwegen D, Baeyens F, Eelen P. Reinstatement of extinguished conditioned responses and negative stimulus valence as a pathway to return of fear in humans. Learn Mem. 2004 Sep-Oct;11(5):549-54. doi: 10.1101/lm.78004.

ReferenceCitation: Ferry B, McGaugh JL. Clenbuterol administration into the basolateral amygdala post-training enhances retention in an inhibitory avoidance task. Neurobiol Learn Mem. 1999 Jul;72(1):8-12. doi: 10.1006/nlme.1998.3904.

ReferenceCitation: Giles J. Beta-blockers tackle memories of horror. Nature. 2005 Jul 28;436(7050):448-9. doi: 10.1038/436448a. No abstract available.

ReferenceCitation: Gisquet-Verrier P, Botreau F, Venero C, Sandi C. Exposure to retrieval cues improves retention performance and induces changes in ACTH and corticosterone release. Psychoneuroendocrinology. 2004 May;29(4):529-56. doi: 10.1016/s0306-4530(03)00085-4.

ReferenceCitation: Herz RS. Are odors the best cues to memory? A cross-modal comparison of associative memory stimuli. Ann N Y Acad Sci. 1998 Nov 30;855:670-4. doi: 10.1111/j.1749-6632.1998.tb10643.x.

ReferenceCitation: Maheu FS, Joober R, Beaulieu S, Lupien SJ. Differential effects of adrenergic and corticosteroid hormonal systems on human short- and long-term declarative memory for emotionally arousing material. Behav Neurosci. 2004 Apr;118(2):420-8. doi: 10.1037/0735-7044.118.2.420.

ReferenceCitation: Przybyslawski J, Roullet P, Sara SJ. Attenuation of emotional and nonemotional memories after their reactivation: role of beta adrenergic receptors. J Neurosci. 1999 Aug 1;19(15):6623-8. doi: 10.1523/JNEUROSCI.19-15-06623.1999.

ReferenceCitation: Quirarte GL, Roozendaal B, McGaugh JL. Glucocorticoid enhancement of memory storage involves noradrenergic activation in the basolateral amygdala. Proc Natl Acad Sci U S A. 1997 Dec 9;94(25):14048-53. doi: 10.1073/pnas.94.25.14048.

ReferenceCitation: Sara SJ. Retrieval and reconsolidation: toward a neurobiology of remembering. Learn Mem. 2000 Mar-Apr;7(2):73-84. doi: 10.1101/lm.7.2.73. No abstract available.

ReferenceCitation: Simson PE, Naylor JC, Gibson B, Schneider AM, Levin D. Dose-sensitive excitation and inhibition of spontaneous amygdala activity by propranolol. Pharmacol Biochem Behav. 2001 May-Jun;69(1-2):85-92. doi: 10.1016/s0091-3057(01)00503-2.

ReferenceCitation: Strange BA, Dolan RJ. Beta-adrenergic modulation of emotional memory-evoked human amygdala and hippocampal responses. Proc Natl Acad Sci U S A. 2004 Aug 3;101(31):11454-8. doi: 10.1073/pnas.0404282101. Epub 2004 Jul 21.

ReferenceCitation: Taylor F, Cahill L. Propranolol for reemergent posttraumatic stress disorder following an event of retraumatization: a case study. J Trauma Stress. 2002 Oct;15(5):433-7. doi: 10.1023/A:1020145610914.

ReferenceCitation: Vaiva G, Ducrocq F, Jezequel K, Averland B, Lestavel P, Brunet A, Marmar CR. Immediate treatment with propranolol decreases posttraumatic stress disorder two months after trauma. Biol Psychiatry. 2003 Nov 1;54(9):947-9. doi: 10.1016/s0006-3223(03)00412-8. Erratum In: Biol Psychiatry. 2003 Dec 15;54(12):1471.

ReferenceCitation: van Stegeren AH, Everaerd W, Cahill L, McGaugh JL, Gooren LJ. Memory for emotional events: differential effects of centrally versus peripherally acting beta-blocking agents. Psychopharmacology (Berl). 1998 Aug;138(3-4):305-10. doi: 10.1007/s002130050675.

ReferenceCitation: van Stegeren AH, Goekoop R, Everaerd W, Scheltens P, Barkhof F, Kuijer JP, Rombouts SA. Noradrenaline mediates amygdala activation in men and women during encoding of emotional material. Neuroimage. 2005 Feb 1;24(3):898-909. doi: 10.1016/j.neuroimage.2004.09.011.

location_facility: Saint-Antoine Hospital, Psychiatriy unit


title: Can we Better Select Patients With Heart Failure for a Primary Prevention Indication of Implantable Cardioverter Defibrillator (ICD)? Evaluation of the Diagnostic Value of 123I Meta-iodobenzylguanidine (MIBG)

acronym: MISTIC

summary: The aim of the study is to assess the cardiac innervation in patients with heart failure to better select candidates for an implantable cardioverter defibrillator. Cardiac innervation will be assessed using an imaging agent administered intravenously.

study_start_date_type: Actual

ipd_sharing: Undecided

location_facility: Groupe Hospitalier Bichat - Claude Bernard

intervention_type: Radiation


title: Evaluating the Necessity of TOT Implantation in Women With Pelvic Organ Prolapse and Occult Stress Urinary Incontinence

acronym: ATHENA

summary: Nowadays the clinical significance of an occult stress urinary incontinence and its optimal treatment is not known.Regarding treatment, there are 2 main approaches : either the systematic preventive treatment of the occult stress urinary incontinence by means of a tension free vaginal tape (TOT) together with the treatment of prolapse or the treatment of prolapse in the first place and treatment of stress incontinence in a second time when and if it appears.This study is expected to provide objective evidence concerning the efficacy and security of TOT implantation for the prevention treatment of occult stress urinary incontinence in women with pelvic organ prolapse and occult urinary incontinence.The perspective is to improve the management of these patients by providing evidence based recommendation for their treatment.

primary_purpose: Prevention

ReferenceCitation: Cortesse A, Jacquetin B, Grise P, Le Normand L, Richard F, Haab F. Prospective multicenter clinical trial of Uretex Sup for surgical treatment of stress urinary incontinence. Int J Urol. 2007 Jul;14(7):611-5. doi: 10.1111/j.1442-2042.2007.01542.x.

intervention_type: Procedure


title: Safety and Long-term Effectiveness of High Frequency Repetitive Transcranial Magnetic Stimulation at the Subacute Phase of Ischaemic Stroke

acronym: RAICup

summary: The aim of the study is to determine if 2-week repetitive transcranial magnetic stimulation at the subacute phase of stroke (between day 7 and day 14) improves significantly arm motility at 3 months with remaining effect at one year, without significant adverse effect.

location_facility: Physiology Department, Hôpital Lariboisière, Université Paris 7


title: Double Blind Randomized Controlled Trial of Recombinant Human Platelet Derived Growth Factor-BB Gel (Regranex Gel®) Versus Hydrogel (Duoderm Hydrogel®) for Healing of MARTORELL's Hypertensive Leg Ulcers. ERAN Trial.

acronym: ERAN

summary:
Background: No medical treatment has proved its efficacy for the treatment of hypertensive leg ulcers in a well designed trial.

Primary aim of the study: to compare the rate of healing in hypertensive leg ulcers treated with becaplermin gel (Regranex Gel®) daily application versus the application of the same quantity of an hydrogel (Duoderm Hydrogel™), corresponding to the excipient of becaplermin gel.

Method: Ambulatory or hospitalized patients presenting with an hypertensive leg ulcer, were randomized to receive either a daily application of becaplermin gel or hydrogel during 8 weeks. At week 8, a pinch graft was proposed to patients whom the ulcer has not healed.

Primary aim of the study: Complete closure at week 8

Secondary aims: percentage of wound area reduction at week 8, complete closure at week 12, pain and quality of life during treatment

Study hypothesis: becaplermin gel may promote the healing of hypertensive leg ulcers and be an alternative medical treatment to the skin graft usually proposed

ReferenceType: derived

ReferenceCitation: Senet P, Vicaut E, Beneton N, Debure C, Lok C, Chosidow O. Topical treatment of hypertensive leg ulcers with platelet-derived growth factor-BB: a randomized controlled trial. Arch Dermatol. 2011 Aug;147(8):926-30. doi: 10.1001/archdermatol.2011.84. Epub 2011 Apr 11.


title: MEOPA Breathing Analgesia vs Local Anesthesia for Oocyte Retrieval in ART: a Prospective, Randomized Controlled Study

acronym: KALOVAL

summary: The purpose of this study is to assess pain, at or after oocyte retrieval, the effectiveness of self-controlled inhalation analgesia by nitrous oxide (N2O of 50% and 50% O2) by the patient compared to a local anesthesia combined with a tablet of 0.5 mg of Alprazolam.

ReferenceCitation: Bauer C, Lahjibi-Paulet H, Somme D, Onody P, Saint Jean O, Gisselbrecht M. Tolerability of an equimolar mix of nitrous oxide and oxygen during painful procedures in very elderly patients. Drugs Aging. 2007;24(6):501-7. doi: 10.2165/00002512-200724060-00006.

location_facility: Hôpital Jean Verdier, service de la médecine de la reproduction, avenue du 14 juillet


title: A Double Blind Randomized Controlled Trial of Greater Occipital Nerve Infiltration in Cluster Headache

acronym: CHCI

summary: the aim of tis study is to demonstrate the efficacy of cortivazol injections at the level of the greater occipital nerve to diminish the frequency of cluster headache (episodic or chronic) attacks during an active period. Injections will be used in adjunct with oral verapamil.

ReferenceCitation: Leroux E, Valade D, Taifas I, Vicaut E, Chagnon M, Roos C, Ducros A. Suboccipital steroid injections for transitional treatment of patients with more than two cluster headache attacks per day: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2011 Oct;10(10):891-7. doi: 10.1016/S1474-4422(11)70186-7. Epub 2011 Sep 6.

location_facility: CHU Lariboisière, AP-HP, Centre des Urgences Céphalées (Emergency Headacha Center)


title: Implant System for Fixation of Cranial Bone Flaps After Craniotomy for Brain Surgery

acronym: CRANIOSG

summary: Bone flaps after craniotomy are typically fixed with suture material, mini plates and others devices. In some cases, fixation with suture material is not secure as it may result in shifting of the bone flap with its dislocation. We will test the safety and efficacy of SKULL GRIP a new device for fixation of the bone flap during cranial procedure comparing to traditional suture materials.

ReferenceCitation: Chibbaro S, Makiese O, Bresson D, Hamdi S, Cornelius JF, Guichard JP, Reiss A, Bouazza S, Vicaut E, Ricci A, Galzio R, Poczos P, George B, Marsella M, Di Emidio P. Skull bone flap fixation - reliability and efficacy of a new grip-like titanium device (Skull Grip) versus traditional sutures: a clinical randomized trial. Minim Invasive Neurosurg. 2011 Oct;54(5-6):282-5. doi: 10.1055/s-0031-1297246. Epub 2012 Jan 25.


title: Cost-effectiveness of Quantiferon Gold in VITRO Test of T-lymphocytic Response for Detection of Latent Tuberculosis in At-risk Healthcare Workers

acronym: QUANTIPS

summary: The accuracy of tuberculin skin test (TST) for detecting latent tuberculosis is limited in countries with a high proportion of population having received vaccination with the BCG. We aim to determine the cost-effectiveness of Quantiferon gold (QTFG), compared to BCG vaccine to detect latent tuberculosis in exposed healthcare workers (HCWs)

ReferenceCitation: Lucet JC, Abiteboul D, Estellat C, Roy C, Chollet-Martin S, Tubach F, Carcelain G; QUANTIPS Study Group. Interferon-gamma release assay vs. tuberculin skin test for tuberculosis screening in exposed healthcare workers: a longitudinal multicenter comparative study. Infect Control Hosp Epidemiol. 2015 May;36(5):569-74. doi: 10.1017/ice.2015.19. Epub 2015 Feb 16.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Cambridge University Press


title: Assessment of the Diagnostic Capacity of a New Sampling Technique for Lower Respiratory Tract Culture for Patients With Acute Infectious Pneumonia Admitted in Intensive Care Unit and Non Intubated.

acronym: Mini-LBA

summary: The aim of this study is to develop a safe and effective technique to take sample for lower respiratory tract cultures easy to perform in conditions of acute respiratory failure and spontaneous ventilation for patients admitted in intensive care unit for acute infectious pneumonia and non intubated. The investigators perform sample collection with a mini bronchoalveolar lavage catheter introduced by nasotracheal way through a suction catheter. The purpose of the study is to assess the microbiological diagnostic capacity of this new technique.

ReferenceCitation: Meyer P, Rousseau H, Maillet JM, Thierry S, Sy O, Vicaut E, Thiolliere F, Choukroun G, Chergui K, Chevrel G, Maury E. Evaluation of blind nasotracheal suctioning and non-bronchoscopic mini-bronchoalveolar lavage in critically ill patients with infectious pneumonia: a preliminary study. Respir Care. 2014 Mar;59(3):345-52. doi: 10.4187/respcare.02356. Epub 2013 Jul 23.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

repositories_concat: CiteSeerX

unpaywall_oa_status: bronze

publisher_dissemination: Daedalus Enterprises

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
PLASTIMED Laboratory


title: Genetic Study of Families Affected by Paget's Disease of Bone

acronym: PAGET

summary:
Paget's disease of bone is a frequent bone disorder which usually starts after the age of 40 and which is characterized by bone pain and deformities. Although often without any symptoms, this disease may have severe complications such as fissures, fractures, neurological compression, or deafness. In some cases, it is a genetic disorder transmitted with a dominant autosomal pattern of inheritance: one of the two parents carrying the disease transmits it to his offspring with a risk of 50% for each child. Since 2002, the first gene involved in Paget's disease of bone is known and 14 mutations of this gene have been published. A study confirmed that the presence of those mutations was associated with younger age of onset and more extensive disease. Thus, the knowledge of those genetic factors in the relatives of an affected individual allows the screening of the patients with a higher risk for complications, who may benefit from a medical follow up and earlier treatment, in order to avoid complications. Indeed, Paget's disease of bone may be treated efficiently by bisphosphonates.

This project aims at identifying and collecting over one year, 15 affected individuals affected by Paget's disease of bone and the relatives up to the second degree of relativeness (a total of 100 individuals is expected). The blood samples may be analysed in order to search for mutations of the previously known gene and/or to search for new mutations on new genes.

time_perspective: Retrospective

ReferenceCitation: Collet C, Michou L, Audran M, Chasseigneaux S, Hilliquin P, Bardin T, Lemaire I, Cornelis F, Launay JM, Orcel P, Laplanche JL. Paget's disease of bone in the French population: novel SQSTM1 mutations, functional analysis, and genotype-phenotype correlations. J Bone Miner Res. 2007 Feb;22(2):310-7. doi: 10.1359/jbmr.061106.

ReferenceCitation: Morissette J, Laurin N, Brown JP. Sequestosome 1: mutation frequencies, haplotypes, and phenotypes in familial Paget's disease of bone. J Bone Miner Res. 2006 Dec;21 Suppl 2:P38-44. doi: 10.1359/jbmr.06s207.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Novartis
Association Rhumatisme et Travail


title: Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS

summary: Probiotics may improve symptoms in IBS patients. The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria.

ReferenceCitation: Camilleri M, Chang L. Challenges to the therapeutic pipeline for irritable bowel syndrome: end points and regulatory hurdles. Gastroenterology. 2008 Dec;135(6):1877-91. doi: 10.1053/j.gastro.2008.09.005. Epub 2008 Oct 9.

collaborators: Association pour l'Etude des Fonctions Digestives

intervention_type: Dietary Supplement


title: Evaluation of the Effect of Respiratory Physiotherapy by Mechanical In-exsufflator on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis: A Pilot Study

summary: The study aims to evaluate the effect of mechanical insufflator-exsufflator on the respiratory functions of Amyotrophic Lateral Sclerosis (ALS) patients evaluated via peak expiratory flow on cough (PEFC) measurements. The evolution of their PEFC is monitored to see if the curative management can have a positive impact on the latter.

status: Recruiting

lead_sponsor: University Hospital, Toulouse

location_facility: SLA Center - Purpan University Hospital Toulouse, FRANCE

status_simplified: Ongoing


title: Study of the Reduction of the Prescriptions of Benzodiazepines and Related After the Discharge of a Service of Follow-up Care and Geriatric Rehabilitation

acronym: BZD

summary:
The significant consumption of Benzodiazepines and related drugs in the elderly outside of good practice recommendations is a major issue in the care of the elderly. Adverse effects have been the subject of numerous studies, leading to falls, addictions and even deaths. The general practitioner is often faced with long-term medication intake which is not consistent with a good benefit/risk balance, but stopping or reducing the dosage remains a problem in current practice.

The Aftercare and Geriatric Rehabilitation services due to their operation (several weeks of hospitalization) seek to adapt the patient's therapies in order to obtain the most convincing benefit/risk balance possible. A reduction or withdrawal of treatments with Benzodiazepines or related drugs are therefore frequently initiated.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Gériatrie - Service de Soins de Soins Médicaux et de Réadaptation - CHU de Strasbourg - France


title: Cardiogenic Acute Pulmonary Edema in Subjects Over 75 Years Old: Impact of Non-invasive Ventilation on Mortality

acronym: CAPE

summary:
People aged over 75 represent almost 10% of the general population, and 12 to 14% of patients consulting emergency departments. Cardiogenic acute pulmonary edema (APO) is a very common reason for admission to the emergency room. The effectiveness of non-invasive ventilation (NIV) has been demonstrated during the management of PAO and would allow, compared to medical treatment alone, a more rapid improvement in clinical and gasometric parameters as well as a reduction in the need for ventilation. orotracheal intubation. On the other hand, the impact of NIV on mortality in cardiogenic PAO seems poorly defined, with lower levels of scientific evidence regarding a possible benefit in terms of survival, particularly in the elderly population.

The objective of this study is to determine whether the use of NIV in cardiogenic PAO in elderly subjects admitted to the emergency room of Strasbourg University Hospital would have an impact in terms of mortality up to 6 months compared to medical treatment alone.


title: Non-inferiority Study in Pediatric Cardiac Surgery Comparing Short 24-hour Antibiotic Prophylaxis to Extended Antibiotic Prophylaxis

acronym: Prophylaxis

summary:
The objective of antibiotic prophylaxis is to prevent bacterial proliferation in order to reduce the risk of postoperative infection.

Numerous recent recommendations show a benefit of a reduced duration of antibiotic prophylaxis in surgery, particularly in pediatrics.

The study focuses on the incidence of postoperative infection by comparing antibiotic prophylaxis with 2nd generation cephalosporin (G2G) for 48 hours to a short antibiotic prophylaxis protocol limited to 24 hours.

The bacterial infections considered were those said to be care-related, according to the criteria of the French Society of Anesthesia and Intensive Care if they occurred within the 3 months postoperative interval and were not present before the surgery:

sepsis
superficial or deep surgical site infection (mediastinitis, sternitis, scar infection)
catheterization infection,
urinary tract infection or
respiratory infection such as pneumopathy acquired under mechanical ventilation

The hypothesis is that reducing the duration of antibiotic prophylaxis does not expose patients to an increased risk of infection and limits exposure to antibiotics

location_facility: Service réanimation pédiatrique médico-chirurgicale spécialisée - CHU de Strasbourg - France


title: Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre

summary: The leakage of oropharyngeal secretions around high-volume low-pressure tracheal tube cuffs is usually considered as a major risk factor for bacterial tracheal colonization and subsequent development of ventilator-associated pneumonia. The rate of leakage around the cuff is related to the pressure differential across the cuff, namely the difference between the pressure of the subglottic fluid above the cuff and the tracheal pressure under the cuff. Consequently, positive end-expiratory pressure (PEEP) improves the sealing around the cuff towards fluid leakage. However, this preventive effect of PEEP is compromised during prolonged mechanical ventilation by tracheal suctioning manoeuvre, which may enhance fluid leakage, by decreasing tracheal pressure. Indeed, in a benchtop model, a suctioning manoeuvre, without disconnection of the ventilator, induced a constant fluid leakage past a high-volume low-pressure tracheal tube cuff when performed with a high level of suction pressure (- 400 mbar) and a large size of suction catheter size (16 French).

ReferenceCitation: Beuret P, Philippon B, Fabre X, Kaaki M. Effect of tracheal suctioning on aspiration past the tracheal tube cuff in mechanically ventilated patients. Ann Intensive Care. 2012 Nov 7;2(1):45. doi: 10.1186/2110-5820-2-45.

lead_sponsor: Centre Hospitalier de Roanne


title: Mucle Resilience: Muscular Markers Predictive of Functional Recovery After Femoral Neck Fracture in Orthogeriatrics

acronym: HIPRESM

summary:
The aging of the population is a major public health problem, particularly with regard to the quality of life and the maintenance of autonomy.

The fracture of the upper end of the femur (EFSF) is a pathology:

Frequent, affecting the elderly: in France, 80,000 patients / year, 83% aged ≥ 75 years (DREES, 2011),
severe, on mortality and autonomy: 40% will not recover their walking capacity earlier than 6 months, 13% of patients > 85 years old walk unaided at 4 months and 11% of patients will be newly admitted to an institution in 6 months after the fracture (UPOG / PSL data).
and costly: costs related to acute care (excluding prostheses and osteosynthesis equipment), are estimated at € 475 million for health insurance in France.

Currently, despite optimized orthogeriatric management, it is difficult to predict how the individual will respond / recover from acute stress related to the EFSF. Physical resilience is an emerging concept in medicine that defines the dynamic ability of a subject to resist or recover from functional decline as a result of stress or disruption. In this context, developing new approaches to assessing resilience is important, to take into account this resilience specific to each patient in order to develop a personalized functional rehabilitation strategy. The objective of the HIPRESM study is to be able to identify, in elderly patients after an EFSF intervention, the muscular signature associated with good functional recovery (= physical resilience). The goal of the investigators is to develop software that will provide this muscle signature by measuring and analyzing parameters from high-definition surface electromyography (HD-sEMG). This technology is innovative, non-invasive and portable, CE marked but not yet used in clinical routine.

ipd_sharing: Yes

ipd_sharing_description: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Université de Technologie de Compiegne

location_facility: APHP - Pitie Salpetriere Hospital - UPOG


title: Health and Sleep Assessment After the Strasbourg Attacks of December 11, 2018

acronym: ELSSAS

summary: Evaluation of the prevalence of post-traumatic stress disorder (PTSD), associated risk factors, health care consumption, and sleep disorders in a civilian population exposed to the December 11, 2018, attacks in Strasbourg. Terrorist attacks have unfortunately become all too frequent on our territory in recent years. A better knowledge of the psychological and psychiatric repercussions on exposed populations is essential in order to better prevent and treat disorders that can have a major functional impact on the lives of exposed individuals and to adapt care during future similar events

location_facility: Service de Psychiatrie d'Urgences, de Liaison et de Psychotraumatologie - CHU de Strasbourg - France


title: Place of Intrathecal CXCL-13 in the Diagnosis of Lyme Neuroborreliosis

summary: Neuroborreliosis (NBL) is diagnosed in 10-15% of patients with Lyme borreliosis. In Europe in adults, the main clinical manifestation is called "Bannwarth syndrome". This includes painful meningoradiculitis, sometimes accompanied by cranial nerve neuritis. Current European guidelines issued by the European Federation of Neurological Societies (EFNS) recommend the following triad for the diagnosis of "definite NBL": (i) Neurological symptoms suggestive of NBL without any other obvious cause; (ii) CSF pleocytosis; (iii) Intrathecal production of specific anti-Borreliella antibodies. CXCL13, C-X-C chemokine motif ligand 13, is a chemokine implicated in B cell chemotaxis. Extensive literature exists on the analysis of CXCL13i as a diagnostic marker for acute NBL. A recent meta-analysis from 2018, published by Rupprecht et al finds an overall sensitivity and specificity of 89% and 96% respectively, indicating satisfactory diagnostic value. In this study, the investigators wish to assess the place of this new marker in the diagnosis of neuroborreliosis before proposing it as a test carried out by the Borrelia CNR.

location_facility: Service Laboratoire de Bactériologie - Plateau Technique de Microbiologie - CHU de Strasbourg - France


title: Study of Radiographic Changes and Their Clinical Implications at 2 Years of Implantation of Shortened Uncemented Femoral Stems in Total Hip Arthroplasty

acronym: THA

summary:
The hip prosthesis market is constantly growing with the number of prostheses reaching 949,000 in 2019. Along with this, there is also an increase in interest in short stems also called shortened stems. Thus on Pubmed, in 5 years, 171 publications have been listed.

Thus, it seems interesting to study and analyze the performance of the shortened stem used in the Department of Orthopedic Surgery and Traumatology of the University Hospitals of Strasbourg and to compare them with the results of the literature.

location_facility: Service de Chirurgie Orthopédique et de Traumatologie du Membre Inférieur - CHU de Strasbourg - France


title: Evaluation of the Long-term Results of Extended Supra-basillary Genioplasty of the "Chin Wing" Type Without Bone Graft: Aesthetic and Functional Satisfaction, Sensory Recovery and Bone Healing

acronym: SASCWatch

summary:
The correction of maxillomandibular dysmorphoses, responsible for both functional discomfort (lip incompetence, ventilation disorders, periodontal disease) but also aesthetic, calls in particular for genioplasty, of which there are several techniques. One of these chin repositioning techniques, called "Chin Wing", cuts the bone to optimize the functional and aesthetic result. While all genioplasty techniques expose the risk of nerve damage and lack of bone consolidation, these parameters are only rarely addressed in the literature in the specific context of this extensive bone cutting.

The objective of this work is to assess the satisfaction of patients who have benefited from chin advancement surgery using the "Chin Wing" technique.

time_perspective: Other

location_facility: Service de Chirurgie Plastique, Reconstructrice, Esthétique et Maxillo-faciale - CHU de Strasbourg - France


title: Evaluation of the Methods and Effectiveness of Care for Eligible Medical and Surgical Patients on Admission in Continuous Monitoring Units

acronym: UNISURC

summary:
In France, Intensive Medicine is carried out in three types of structures: intensive care units, intensive care unit and units Continuous Monitoring (USC). Created in the 90s as intermediate structures between conventional care units and intensive care units, these units are assigned to the care of patients whose conditions and treatment are fear the occurrence of one or more critical failures requiring to be monitored, or whose condition, at the end of one or more critical failure is too severe or unstable to allow a return to a classical inpatient unit.

Thus, USC represent a milestone in the journey of patients whose condition is critical: patients from the emergency services, patients in the immediate postoperative period, coming out of intensive care patients, or finally in conventional hospitalization patients whose condition s 'worse. The creation of the USC is not subject to authorization but must be contractualized between the hospital and the Regional Health Agency (ARS) because it is resource intensive. Organizations and their operating modes are guided by the recommendations of the French Society of Anesthesia and Intensive Care (SFAR), and the Society of French Language Resuscitation (SRLF) published in 2005.The US establishment has a beneficial effect on the quality of care and the care pathway of patients at risk shown by the reduction in morbidity and mortality, the rate of admission and / or USC readmission of length of stay and hospital stay costs.

It is possible to objectify provided first establish an inventory on the activity of these units and the patient base supported. To judge the benefit of the assumption by the USC, it is necessary to assess the adequacy of patients managed with an updated specification and defined by a group of experts.

appel_a_projets: PREPS

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: UNISURC

titre: Évaluation des modalités et de l'efficacité de la prise en charge des patients médicaux et chirurgicaux éligibles à l'admission en Unités de Surveillances Continues (USC).

discipline_principale: organisation des soins

nom_porteur: BEAUSSIER

prenom_porteur: Marc


title: Characterization and Significance of Circulating Microvesicles in Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease

acronym: MICROBOPH

summary:
Mild to moderate pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (COPD); such a complication is associated with increased risks of exacerbation and decreased survival. A small proportion of COPD patients may present with severe pulmonary hypertension, defined by a mean pulmonary artery pressure more than 35 mmHg (or more than 20 mmHg with a low cardiac index < 2 l/min/m2) with pulmonary vascular resistance more than 3 Wood units, measured by right heart catheterization (RHC). In these patients, pulmonary microvessels remodeling is the main cause of increase in pulmonary arterial pressure and is thought to result from the combined effects of hypoxia, inflammation, and loss of capillaries but the mechanisms are complex.

For these patients, no drugs have been approved for treatment and lung transplantation must be considered for the more severe patients who are eligible. A better characterization of these patients is needed.

We hypothesize that microvesicles generation and endothelial damage could be related to the severity of pulmonary hypertension due to COPD, assessed by pulmonary hemodynamic parameters. Circulating biomarkers of vascular damage and cell activation will be measured in blood samples from 80 COPD patients who have hemodynamic assessment by RHC. To go further, the origin of the particles will be characterized.

study_start_date_type: Anticipated

status: Not yet recruiting

location_facility: Hôpitaux Universitaire de Strasbourg - Service Pneumologie - centre de compétence de l'hypertension artérielle pulmonaire - France


title: Estimated Physical Activity of Congestive Heart Failure Patients by a Physical Activity Questionnaire : Concordance Study.

summary: The treatment and follow-up of congestive heart failure (CHF) represents a major part of France's health expenses. The beneficial effects of cardiac rehabilitation is well established, especially regarding the reduction of dyspnea, exercise limitation and fatigue and leads ultimately to a better quality of life. Maintaining these benefits in secondary prevention requires an improvement in daily physical activity, which is challenging and supposes a close follow-up difficult to perform on a daily living basis. However, a better knowledge of the type and dose of daily physical activity of this population would be very beneficial for the practitioner to prescribe or advise individually the type and the dose of physical activity required to maintain the benefits of cardiac rehabilitation. To date, only a physical activity questionnaire adapted to CHF could provide information regarding both the type and dose of daily physical activity. Such a questionnaire has been developed by our research team and allows an estimation of daily energy expenditure as well as the daily energy expended in its physical activity dimensions (rest, activities < 3 MET, activities between 3 and 5 MET, and activities > 5 MET). During its first step of validation, daily and physical activity energy expenditure estimated by this questionnaire was correlated to various factors of physical condition and notably, to peak V'O2 (R=0.71), prognostic factor largely recognized in CHF. A second step of validation was a pilot study comparing the estimation of daily energy expenditure by the questionnaire with a measurement of free-living daily energy expenditure with the doubly labelled water (DLW) method in 11 middle-aged males patients suffering CHF (NYHA I to III). Daily energy expenditure estimated from the questionnaire was very close to daily energy expenditure measured from the DLW method (R2 = 0.81; individual relative error < 7%). However, the high cost of the DLW method reduced the population studied to a small sample, which is a major limitation of this study since the sample was somewhat different to general CHF population in France.

ReferenceCitation: Garet M, Barthelemy JC, Degache F, Costes F, Da-Costa A, Isaaz K, Lacour JR, Roche F. A questionnaire-based assessment of daily physical activity in heart failure. Eur J Heart Fail. 2004 Aug;6(5):577-84. doi: 10.1016/j.ejheart.2003.11.022.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service de Physiologie Clinique et de l'Exercice, CHU de Saint-Etienne


title: Pilot Suty of the Assessment of Food Preferences After Bariatric Surgery (BariaTaste Pilot)

summary:
More than 50,000 patients in France benefit from bariatric surgery every year. However, nutritional complications (protein malnutrition, hypoglycaemia) are common and primary or secondary weight failures (weight recovery) account for almost 20% of operated. Weight loss and the metabolic effects of surgery are not related only to a reduction in dietary intakes, but also to mechanisms independent of caloric reduction, such as eating behaviour after bariatric surgery (Gastric Bypass or sleeve gastrectomy). These choices are guided by perceived changes in the properties of the food, resulting in changes in tastes, palatability and more generally food preferences. Among available tools to evaluate dietary preferences we selected the Food Leeds Preference Questionnaire (FLPQ) to assess those modifications. During this test, photographs of food products classified according to predetermined characteristics are presented with different instructions and response design to estimate liking, wanted for food, implicitly or explicitly. Our main hypothesis is that the use of the Food Leeds Preference Questionnaire will highlight differences in dietary preferences according to the type of bariatric surgery performed.

We will be conducted a study observational study on three parallel groups: a control group composed of patients suffering from unoperated obesity, a group of patients operated for a sleeve gastrectomy and a group of patients operated for a gastric bypass. We will include 45 patients per group. The patients will have to pass the Leeds Food Preference Questionnaire (LFPQ). Our judgment criterion will be the degree of food preference assessed using the LFPQ. Participants will also be assessed on behavioural parameters with the Binge Eating Scale, the Yale Food Addiction Scale Version 2.0 and the Urgency, lack of Premeditation, lack of Perseverance and Sensation seeking Impulsive behavior scale (UPPS-P) short version.

time_perspective: Cross-Sectional

lead_sponsor: Hospices Civils de Lyon


title: High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma: a Feasibility Study. A Multicentric, Open, Uncontrolled Study

summary:
This study is a multicentre, open, uncontrolled trial for the observation of histological changes in breast fibroadenoma following high intensity focused ultrasound (HIFU).

This study will be conducted in France in 20 patients with breast fibroadenoma with indication for a surgical resection. The patient will receive an HIFU treatment and 6 months after treatment, the need of the surgery is evaluated.

primary_purpose: Basic Science

lead_sponsor: Theraclion

location_facility: Hôpital Jeanne de Flandre, CHU de Lille 2 Avenue Oscar Lambret

lead_sponsor_type: industriel


title: Study of the SARS-COV-2 (COVID-19) Serological Profile of an Army Training Hospital Staff

acronym: SEROSARSCOV

summary:
Emerging in China in December 2019, Covid-19, whose pathogen is SARS-Cov-2, was declared a global pandemic in March 2020. The clinical presentation is highly variable, ranging from asymptomatic forms to acute respiratory distress and even death. Transmission occurs through droplets, with a R0 of approximately 3.

Rapidly, population protection measures were put in place by governments, including the confinement of all persons whose functions were not considered essential and the closure of educational institutions.

Health care institutions are places at risk of Covid-19 transmission and hospital staff are particularly exposed, either through direct contact with patients, contact with exposed persons or through the environment. In order to protect personnel, hygiene measures were immediately recalled and reinforced.

This study is aimed at evaluating the incidence rate of anti-SARS-Cov2 seroconversion over 2 months among hospital staff, without any supposed anti-Covid treatment 19.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Robert Picqué

location_facility: Hôpital d'Instuction des Armées Sainte-Anne

intervention_type: Diagnostic Test


title: CHRONIC OPTIC NEUROPATHY IN MULTIPLE SCLEROSIS: DEMYELINATING AND/OR PRIMARY DEGENERATIVE PATHOPHYSIOLOGY?

summary:
Patients with multiple sclerosis (MS) may show chronic signs of optic neuropathy (CON) that may follow acute optic neuritis (secondary form of CON, S-CON) or occur independently of any acute demyelinating lesion of the optic nerve (primary form of CON, P-CON). In both S-CON and P-CON, a long term progressive ganglion cell axonal loss occurs. This axonal damage could be secondary to retrograde atrophy of axons within plaques of demyelination or a primary progressive degeneration of ganglion cells, but the underlying physiopathology has not been fully questioned in the different profile types of CON.

In this project, investigators aim at understanding the pathophysiology of S-CON and P-CON, i.e. secondary to demyelination or primary degeneration, in patients complaining of persistent visual complaints. In a first cross sectional study, 30 MS patients with mild to moderate P-CPON or S-CON and 30 age-matched control subjects will perform an extensive neuro-ophthalmological assessment including clinical examination, visual evoked potentials (pattern and low contrast), electroretinogram (pattern and multifocal ERG), OCT (peripapillary and macular volume scan segmentation protocols) and MRI of the optic nerve. In these patients with mild to moderate CON, investigators aim at differentiating patients showing predominant demyelination from those showing pure or predominant axonal degeneration. Visual function assessment and degree of axonal degeneration will be compared and correlated in the two types of underlying pathophysiology and in the group of control subject. In a following longitudinal study, the patients will be re-assessed a year later in order to evaluate the progression of CON in both profile types. Our hypothesis would be that visual function and progression is worse in the degeneration group as compared to the demyelination group. This study should help to find reliable measures of the pathophysiology of CON and correlate it with the long-term visual prognostic of the disease.

sponsor_collaborators:
Hospices Civils de Lyon
Fondation pour la Recherche Médicale

location_facility: Unité de Neuro-Ophtalmologie - Hôpital Neurologique - HOSPICES CIVILS DE LYON


title: Validation of a Dynamic Evaluation Tool in Respiratory Failure by Ambulatory Inductance Plethysmography

acronym: TELERESP

summary: Determing optimal time of ventilator disconnection is a challenge for both acute and chronic neuromuscular disease. In one case it is helpful for weanning from ventilator and in the other to optimize daytime ventilation in the most severe patients. The investigators propose to validate a new non invasive tool for monitoring respiratroy parameters in neuromuscular patients in both acute and chronic conditions.

ReferenceCitation: Modalités pratiques de la ventialtion non invasive en pression positive, au long cours, a domicile, dans les maladies neuromusculaires. Rev Mal Respir 2006;23:S3-S40. Toussaint M, Steens M, Wasteels G, Soudon P. Diurnal ventilation via mouthpiece: survival in end-stage Duchenne patients. Eur Respir J 2006;28(3):549-55. Seneviratne J, Mandrekar J, Wijdicks EF, Rabinstein AA. Predictors of extubation failure in myasthenic crisis. Arch Neurol 2008;65(7):929-33. Prigent H, Orlikowski D, Letilly N, Falaize L, Annane D, Sharshar T, et al. Vital Capacity Versus Maximal Inspiratory Pressure in Patients with Guillain-Barre Syndrome and Myasthenia Gravis. Neurocrit Care. Kohler M, Clarenbach CF, Bahler C, Brack T, Russi EW, Bloch KE. Disability and survival in Duchenne muscular dystrophy. J Neurol Neurosurg Psychiatry 2009;80(3):320-5. Brouillette RT, Morrow AS, Weese-Mayer DE, Hunt CE. Comparison of respiratory inductive plethysmography and thoracic impedance for apnea monitoring. J Pediatr 1987;111(3):377-83. Calabrese P, Besleaga T, Eberhard A, Vovc V, Baconnier P. Respiratory inductance plethysmography is suitable for voluntary hyperventilation test. Conf Proc IEEE Eng Med Biol Soc 2007;2007:1055-7. Eberhard A, Calabrese P, Baconnier P, Benchetrit G. Comparison between the respiratory inductance plethysmography signal derivative and the airflow signal. Adv Exp Med Biol 2001;499:489-94. Redline S, Budhiraja R, Kapur V, Marcus CL, Mateika JH, Mehra R, et al. The scoring of respiratory events in sleep: reliability and validity. J Clin Sleep Med 2007;3(2):169-200.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Evaluation of the Relevance Indicators of Quality of Care for Dying Patients Based on Analysis of Care and Follow-up Course of the Leonetti Law. EFIQUAVIE Study

acronym: EFIQUAVIE

summary:
The study uses a mixed method study to evaluate wether the use of the indicators of the Quality of end-of-life cancer care, developed by Earle et al [Earle JCO 2003; DOI: 10.1200/JCO.2003.03.059] would be relevant and measurable in France. The qualitative part of study was designed to investigate the representations of quality by face-to face interviews with family carer of recently deceased cancer patients, and with their oncologists, and nurses. The quantitative part of the study, consisted in a decedents case series analysis, diagnosed with advanced cancer and followed up in 5 centers. Data on trajectory of care were collected from different complementary sources associating national mortality data, hospital activity data, and health records.

The study was approved by the French data protection authority (CNIL) number 611273.

ipd_sharing: No

location_facility:
APHP Hôpital Cochin
APHP Hôpital Henri Mondor
APHP Hôpital Européen Georges Pompidou
Institut Gustave Roussy
Institut Curie


title: BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III French Satellite

summary:
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures.

The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.

Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.

lead_sponsor: Biotronik France

location_facility: Clinique St Augustin, Service Cardiologie Interventionnelle

location_facility: Clinique Convert, Cardiologie Interventionnelle

location_facility: CHU de Clermont Ferrand, Hôpital Gabriel Montpied

location_facility: Hôpital Nord de Marseille, Service de Cardiologie


title: Effects of Fluid Balance Control in Critically Ill Patients: A Multicenter Randomized Study

acronym: POINCARE

summary: Most ICU patients develop a positive fluid balance, mainly during the two first weeks of their stay. The causes are multifactorial: a reduced urine output subsequent to shock state, positive pressure mechanical ventilation, acute renal failure, post-operative period of major surgical procedures, and simultaneous fluid loading to maintain volemia and acceptable arterial pressure. Additionally, the efficacy of fluid loading is frequently suboptimal, in relation to severe hypoalbuminemia and inflammatory capillary leakage. This results usually in a cumulated positive fluid balance of more than 10 litres at the end of the first week of stay. A high number of studies have showed that such a positive fluid balance was an independent factor of worse prognosis in selected populations of ICU patients: acute renal failure, acute respiratory distress syndrome (ARDS), sepsis, post-operative of high risk surgery. However, little is known about the putative causal role of positive fluid balance by itself on outcome. However, in two randomized controlled studies in patients with ARDS, a strategy of fluid balance control has been demonstrated to reduce time under mechanical ventilation and ICU length of stay with no noticeable adverse effects. Although avoiding fluid overload is now recommended in ARDS management, there is no evidence that this approach would be beneficial in a more general population of ICU patients (i.e. with sepsis, acute renal failure, mechanical ventilation). In addition, fluid restriction -mainly if applied early could be deleterious in reducing both tissue oxygen delivery and perfusion pressure. There is a place for a prospective study comparing a "conventional" attitude based on liberal fluid management throughout the ICU stay with a restrictive approach aiming at controlling fluid balance, at least as soon as the patient circulatory status is stabilized. The latter approach would use a simple algorithm using fluid restriction and diuretics based on daily weighing, a common procedure in the ICU, probably more reliable than cumulative measurement of fluid movements in patients whose limits have been underlined.

ReferenceCitation: Agrinier N, Monnier A, Argaud L, Bemer M, Virion JM, Alleyrat C, Charpentier C, Ziegler L, Louis G, Bruel C, Jamme M, Quenot JP, Badie J, Schneider F, Bollaert PE. Effect of fluid balance control in critically ill patients: Design of the stepped wedge trial POINCARE-2. Contemp Clin Trials. 2019 Aug;83:109-116. doi: 10.1016/j.cct.2019.06.020. Epub 2019 Jun 29.

lead_sponsor: Central Hospital, Nancy, France

sponsor_collaborators:
Central Hospital, Nancy, France
Ministry of Health, France

location_facility: CentreHospitalier Régional et universitaire

location_facility: Centre Hospitalier Régional et Universitaire

appel_a_projets: PHRCN

region: Grand Est

nom_etablissement: CHRU DE NANCY

type_etablissement: CH

acronyme: POINCARE

titre: Effets du contrôle de l'inflation hydro-sodée chez les patients en réanimation

discipline_principale: anesthésiologie / réanimation

nom_porteur: BOLLAERT

prenom_porteur: Pierre Edouard


title: The ICCA Study (Early Identification of Candida in Intra-abdominal CAndidiasis)

acronym: ICCA

summary:
Intra-abdominal candidiasis remains the first origin of invasive candidiasis in critically ill patients with a mortality up to 60%. This high mortality is partly related to delay of anti-fungal treatment administration. According to experts in the field, new diagnostic methods to rapidly detect Candida in intra-abdominal infections is mandatory because the current strategies suffer from a lack of both sensitivity and specificity.

The calscreener (SYMCEL®) is a new diagnostic tool to rapidly identify the presence of pathogens in biological samples based on micrometabolic activity detection. This technology also allows to measure the metabolic activity of pathogens.

The ICCA project will test the feasibility, the accuracy and the diagnostic performance of the calscreener on an existing biological collection of peritoneal fluid. This collection came from a cohort of critically ill patients with intra-abdominal infection which required abdominal surgery. Intra-abdominal infections consist of bacterial peritonitis and intra-abdominal candidiasis. The presence of pathogens (bacteria and yeast) is already known, the peritoneal fluid being stored after routine analysis (bacteriology / mycology).

In addition to the detection / identification of yeast will be investigated in this project, the cal screener will be used to evaluate the metabolic profile of Candida albicans in the peritoneal fluid, alone and with bacteria. This objective aims to evaluate the virulence of Candida in the peritoneal fluid from a metabolic perspective. The results will be compared to phenotypic and molecular evaluation.

sponsor_collaborators:
Central Hospital, Nancy, France
SYMCEL


title: Evaluation of Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane in Intensive Care

summary: This study aims to demonstrate equivalence in terms of molecule removal between continuous hemodialysis using an "enhanced middle molecule clearance" membrane(Ultraflux EMiC2) and continuous hemofiltration using a standard membrane (Ultraflux AV1000S) in ICU patients requiring continuous renal replacement therapy.

lead_sponsor: Fresenius Medical Care France

sponsor_collaborators:
Fresenius Medical Care France
Hospices Civils de Lyon


title: Evaluating of the Benefit to the Patient by Managing of His Anticoagulation Treatment by an Anti-coagulation Clinic

acronym: CREATIF

summary:
Main objective: To evaluate the impact of CREATIF (an anticoagulation clinic in Ile de France) on monitoring and management of patients treated with VKAs compared with usual primary care.

Study hypothesis: The investigators suppose that patients will have a better quality of anticoagulation when they are managed by CREATIF than by their usual General Physicians (GP)

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France

location_facility: Service d'hématologie - Hôpital Lariboisière


title: French Register of Patients With Spinal Muscular Atrophy

acronym: SMA

summary: The primary objectives of the study are to obtain clinically meaningful data on survival and outcomes of all the patients with spinal muscular atrophy (SMA) 5q types 1 through 4 (according to international classification), being followed in the reference centers of the disease in France between September 1, 2016 and August 31, 2024. The registry will collect retrospectively and prospectively the longitudinal data of the long-term follow-up for child and adult patients, under real life conditions of current medical practice, in order to document the clinical evolution of patients (survival, motor, respiratory, orthopedic and nutritional), the conditions of use of the treatments, the mortality rates of treated and untreated patients, the tolerance of the treatments, adverse events in order to better define their places in the therapeutic strategy.

location_facility: Unité neuromusculaire, Service de Neurologie et Réanimation Pédiatrique, (French neuromuscular reference network (FILNEMUS), Hôpital Raymond Poincaré,


acronym: Visage 3

summary:
The frailty and frail elderly was defined in 2001 by Fried as a physiological state of heightened vulnerability to external shocks. 5 criteria for classifying the elderly in 3 categories: frail, pre-frail and not frail. The prevalence of frailty in the general population was estimated to be 7%, 10% and 20% for over 65 years and 45% for over 85 years. This concept is explored in some chronic diseases, in order to prevent the loss of autonomy and tailor the treatment. In the carrier population of HIV, a North American retrospective study showed the frailty syndrome manifested as early as 10 years before, than in the general population. Furthermore various studies show in this specific population, increased incidence of diseases linked to age, suggesting an accelerated and premature aging.

objectives: The objective of this study is to determine the prevalence of frailty defined Fried syndrome in a population of subjects aged 50 and over Holders of chronic HIV infection.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Behavioral


title: Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence

acronym: TransEAsome

summary:
Oesophageal atresia (OAEA), a malformation of the oesophagus present from birth, is characterized by the interruption of the continuity of the oesophagus, which then ends in a cul-de-sac. (Source: Fimatho) An operation is then required to restore continuity to the esophagus. Although this operation enables the vast majority of children to survive the neonatal period, health problems such as gastro-oesophageal reflux, eating difficulties, respiratory problems and growth problems persist throughout life.

The aim of the project is to create a prospective cohort of adolescents aged 13/14, nested in the national AO registry. of adolescents born with esophageal atresia, including a biobank of esophageal mucosa and plasma blood samples. Once the clinical and omic data have been collected, the data will be transferred to the France Cohortes information system for analysis, in order to assess the long-term outcome of this rare disease and establish multi-omic profiles. Once the clinical data have been collected and the omics data (derived from analysis of the biobank's biological samples) have been generated, they will be analyzed by the project partners to assess the long-term outcome of OA and establish multiomic profiles. The raw data will be available on the France Cohorte platform.

lead_sponsor: University Hospital, Lille

collaborators: Institut National de la Santé Et de la Recherche Médicale, France