title: Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure in Patients With Persistent Atrial Fibrillation: a Randomized, Multicentric, and Comparative Study

acronym: PACIFIC

summary:
This study aims at assessing whether electric cardioversion can act as a discriminant factor between patients requiring Pulmonary Vein Isolation (PVI) procedure alone or PVI procedure combined with substrate modulation.

All included patients will undergo an electric cardioversion, then:

Patients with electric cardioversion success will be treated as per Standard of Care and according to ESC recommendations (2020). A prospective registry will be implemented for these patients.

Patients with electric cardioversion failure will be randomized in the study between 2 ablative procedures:

PVI procedure alone
PVI procedure combined with substrate modulation

ReferenceCitation: Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL. Corrigendum to: 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Oct 21;42(40):4194. doi: 10.1093/eurheartj/ehab648. No abstract available.

ReferenceCitation: Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.

ReferenceCitation: Sanders P, Hocini M, Jais P, Sacher F, Hsu LF, Takahashi Y, Rotter M, Rostock T, Nalliah CJ, Clementy J, Haissaguerre M. Complete isolation of the pulmonary veins and posterior left atrium in chronic atrial fibrillation. Long-term clinical outcome. Eur Heart J. 2007 Aug;28(15):1862-71. doi: 10.1093/eurheartj/ehl548.

ReferenceCitation: Knecht S, Hocini M, Wright M, Lellouche N, O'Neill MD, Matsuo S, Nault I, Chauhan VS, Makati KJ, Bevilacqua M, Lim KT, Sacher F, Deplagne A, Derval N, Bordachar P, Jais P, Clementy J, Haissaguerre M. Left atrial linear lesions are required for successful treatment of persistent atrial fibrillation. Eur Heart J. 2008 Oct;29(19):2359-66. doi: 10.1093/eurheartj/ehn302. Epub 2008 Jul 8.

ReferenceCitation: Valderrabano M, Peterson LE, Bunge R, Prystash M, Dave AS, Nagueh S, Kleiman NS. Vein of Marshall ethanol infusion for persistent atrial fibrillation: VENUS and MARS clinical trial design. Am Heart J. 2019 Sep;215:52-61. doi: 10.1016/j.ahj.2019.04.022. Epub 2019 May 11.

ReferenceCitation: Kim DT, Lai AC, Hwang C, Fan LT, Karagueuzian HS, Chen PS, Fishbein MC. The ligament of Marshall: a structural analysis in human hearts with implications for atrial arrhythmias. J Am Coll Cardiol. 2000 Oct;36(4):1324-7. doi: 10.1016/s0735-1097(00)00819-6.

ReferenceCitation: Valderrabano M, Chen HR, Sidhu J, Rao L, Ling Y, Khoury DS. Retrograde ethanol infusion in the vein of Marshall: regional left atrial ablation, vagal denervation and feasibility in humans. Circ Arrhythm Electrophysiol. 2009 Feb;2(1):50-6. doi: 10.1161/CIRCEP.108.818427.

ReferenceCitation: Dave AS, Baez-Escudero JL, Sasaridis C, Hong TE, Rami T, Valderrabano M. Role of the vein of Marshall in atrial fibrillation recurrences after catheter ablation: therapeutic effect of ethanol infusion. J Cardiovasc Electrophysiol. 2012 Jun;23(6):583-91. doi: 10.1111/j.1540-8167.2011.02268.x. Epub 2012 Mar 19.

ReferenceType: result

ReferenceCitation: Pambrun T, Denis A, Duchateau J, Sacher F, Hocini M, Jais P, Haissaguerre M, Derval N. MARSHALL bundles elimination, Pulmonary veins isolation and Lines completion for ANatomical ablation of persistent atrial fibrillation: MARSHALL-PLAN case series. J Cardiovasc Electrophysiol. 2019 Jan;30(1):7-15. doi: 10.1111/jce.13797. Epub 2018 Dec 21.

publisher_dissemination: Wiley

ReferenceCitation: Rivard L, Hocini M, Rostock T, Cauchemez B, Forclaz A, Jadidi AS, Linton N, Nault I, Miyazaki S, Liu X, Xhaet O, Shah A, Sacher F, Derval N, Jais P, Khairy P, Macle L, Nattel S, Willems S, Haissaguerre M. Improved outcome following restoration of sinus rhythm prior to catheter ablation of persistent atrial fibrillation: a comparative multicenter study. Heart Rhythm. 2012 Jul;9(7):1025-30. doi: 10.1016/j.hrthm.2012.02.016. Epub 2012 Feb 15.

ReferenceCitation: Boveda S, Metzner A, Nguyen DQ, Chun KRJ, Goehl K, Noelker G, Deharo JC, Andrikopoulos G, Dahme T, Lellouche N, Defaye P. Single-Procedure Outcomes and Quality-of-Life Improvement 12 Months Post-Cryoballoon Ablation in Persistent Atrial Fibrillation: Results From the Multicenter CRYO4PERSISTENT AF Trial. JACC Clin Electrophysiol. 2018 Nov;4(11):1440-1447. doi: 10.1016/j.jacep.2018.07.007. Epub 2018 Aug 25.

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

ReferenceCitation: Su WW, Reddy VY, Bhasin K, Champagne J, Sangrigoli RM, Braegelmann KM, Kueffer FJ, Novak P, Gupta SK, Yamane T, Calkins H; STOP Persistent AF Investigators. Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial. Heart Rhythm. 2020 Nov;17(11):1841-1847. doi: 10.1016/j.hrthm.2020.06.020. Epub 2020 Jun 24.

ReferenceCitation: Derval N, Duchateau J, Denis A, Ramirez FD, Mahida S, Andre C, Krisai P, Nakatani Y, Kitamura T, Takigawa M, Chauvel R, Tixier R, Pillois X, Sacher F, Hocini M, Haissaguerre M, Jais P, Pambrun T. Marshall bundle elimination, Pulmonary vein isolation, and Line completion for ANatomical ablation of persistent atrial fibrillation (Marshall-PLAN): Prospective, single-center study. Heart Rhythm. 2021 Apr;18(4):529-537. doi: 10.1016/j.hrthm.2020.12.023. Epub 2020 Dec 29.

location_facility: Hôpital Européen Georges Pompidou Service de cardiologie - Unité rythmologie

location_facility: Clinique Pasteur Service de cardiologie/rythmologie


title: Better Understand Motor Deficits Associated With Autism Spectrum Disorders: Development of an Assessment Protocol

acronym: MOTRICITE TSA

summary: This research is a case-control study aiming to characterize motor peculiarities (objective quantitative and qualitative measures) and its psycho-physiological correlates of children with ASD.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Anticipated

ReferenceCitation: Biffi E, Costantini C, Ceccarelli SB, Cesareo A, Marzocchi GM, Nobile M, Molteni M, Crippa A. Gait Pattern and Motor Performance During Discrete Gait Perturbation in Children With Autism Spectrum Disorders. Front Psychol. 2018 Dec 11;9:2530. doi: 10.3389/fpsyg.2018.02530. eCollection 2018.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: University of Milano-Bicocca - BOA - Bicocca Open Archive

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central;boa.unimib.it

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

ReferenceCitation: Cazalets JR, Bestaven E, Doat E, Baudier MP, Gallot C, Amestoy A, Bouvard M, Guillaud E, Guillain I, Grech E, Van-Gils J, Fergelot P, Fraisse S, Taupiac E, Arveiler B, Lacombe D. Evaluation of Motor Skills in Children with Rubinstein-Taybi Syndrome. J Autism Dev Disord. 2017 Nov;47(11):3321-3332. doi: 10.1007/s10803-017-3259-1.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

ReferenceCitation: D'Mello AM, Stoodley CJ. Cerebro-cerebellar circuits in autism spectrum disorder. Front Neurosci. 2015 Nov 5;9:408. doi: 10.3389/fnins.2015.00408. eCollection 2015.

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

repository_institution: University of Illinois at Chicago - INDIGO

repositories_concat: PubMed Central;figshare.com

ReferenceCitation: Eggleston JD, Harry JR, Cereceres PA, Olivas AN, Chavez EA, Boyle JB, Dufek JS. Lesser magnitudes of lower extremity variability during terminal swing characterizes walking patterns in children with autism. Clin Biomech (Bristol, Avon). 2020 Jun;76:105031. doi: 10.1016/j.clinbiomech.2020.105031. Epub 2020 May 7.

oa_host_type: repository

version: acceptedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: Hak L, Houdijk H, Beek PJ, van Dieen JH. Steps to take to enhance gait stability: the effect of stride frequency, stride length, and walking speed on local dynamic stability and margins of stability. PLoS One. 2013 Dec 13;8(12):e82842. doi: 10.1371/journal.pone.0082842. eCollection 2013.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: Vrije Universiteit Amsterdam - VU Research Portal

lead_sponsor: Centre Hospitalier Charles Perrens, Bordeaux

location_facility:
Centre Hospitalier Charles Perrens
Centre Hospitalier La Rochelle Re Aunis
CHU de LIMOGES
Centre Hospitalier Henri Laborit


title: Assesment of the Efficacy of Personalized Parent-child Psychotherapy Evaluating Symptoms in Children Under 3 Years Old and Parent-child Interaction.

acronym: ECRIN

summary: This study aims to assess the efficacy at 4 months of a personalized strategy comparatively to a standard Psychodynamic Integrative Therapy, on childrens' symptom improvment

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU de Reims
CHU de Montpellier
GHU Paris Psychiatrie et Neurosciences
CHU de Besançon

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Ongoing

appel_a_projets: PHRCN

region: Bourgogne-Franche-Comté

nom_etablissement: CHU BESANCON

type_etablissement: CH

acronyme: EPSYPE

titre: Etude contrôlée randomisée de l'efficacité d'une stratégie thérapeutique personnalisée des psychothérapies parent-enfant de 0 à 3 ans (Guidance Interactive ou Thérapie Psychodynamique) versus soins usuels par thérapie Psychodynamique sur l'amélioration de l'interaction parentenfant dans les troubles de l'interaction.

discipline_principale: psychiatry

nom_porteur: VULLIEZ-COADY

prenom_porteur: Lauriane


study_start_date_type: Anticipated

acronym: T-FORE

intervention_type: Drug

lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary: The purpose of this study is to evaluate whether FMT by frozen stool capsules in pediatric UC patients in remission after corticosteroid treatment, can modify their dysbiotic gut microbiota by increasing the richness of their microbiota at 6 months.

sponsor_collaborators: MRSU 938 - Research Center of Saint Antoine

location_facility: Department of gastroenterology, Armand Trousseau Hospital

location_facility: Department of Pediatric Gastroenterology, Robert Debré Hospital

location_facility: Department of Pediatric Gastroenterology, Hepatology and Nutrition - Necker - Enfants Malades Hospital

status: Not yet recruiting

title: Pilot Study of a New Technique of Oral Fecal Transplantation Using Frozen Stool Capsules for the Maintenance Treatment of Pediatric Ulcerative Colitis.

type: EudraCT Number

source: euctr

appel_a_projets: PHRCI

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: T-FORE

titre: Etude pilote de faisabilité d'une nouvelle technique de Transplantation Fécale Orale utilisant des gélules de selles congelées pour le traitement d'entretien des RCH à début pédiatrique

discipline_principale: autre

nom_porteur: PIGNEUR

prenom_porteur: Bénédicte


title: Impact of Allo-HSCT on Bone Remodeling: Evolution of Bone Mineral Density and Architecture Measured by Bone Densitometry Coupled With FRAX / TBS in Allo-HSCT

acronym: REMODALLO

summary: Evaluation of variation of mineral density and bone microarchitecture after allogeneic HSCTs transplant in hematologic malignancies. Comparison with the general population.

lead_sponsor: University Hospital, Caen

location_facility:
Chu Amiens
CHU CAEN
Chu Rouen
Chu Lille

intervention_type: Other

region: Normandie

nom_etablissement: CHU DE CAEN NORMANDIE

acronyme: REMODALLO

titre: Impact de l'allogreffe de CSH sur le remodelage osseux : Evolution des marqueurs biologiques CTX et PINP, de la densité et de l'architecture minérale osseuse mesurés par densitométrie osseuse couplée au FRAX / TBS chez l'allogreffé.

discipline_principale: cancer prévention allogreffe de cellules souches hématopoïétiques ostéoporose densitométrie osseuse tbs frax

nom_porteur: LANCESSEUR

prenom_porteur: Charles


type: Other Identifier

title: Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup

summary:
EUROSCUP Fixe is intended for use in primary and revision total hip replacement surgery.

Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

As part of post market vigilance, EUROS will collect data on EUROSCUP Fixe performances and safety

status: Active, not recruiting

study_type: Observational

time_perspective: Other

lead_sponsor: EUROS

location_facility:
Clinique Esquirol Saint Hilaire
Clinique de L'Atlantique
Centre Hospitalier SECLIN
Clinique St Roch

intervention_type: Device

lead_sponsor_type: industriel


title: Single Case Experimental Design (SCED) Comparing an Off-the-shelf Carbon Ankle Foot Orthosis (SPRYSTEP) Versus an off-the Shelf Standard Plastic Ankle Foot Orthosis in the Treatment of Walking Functional Impairment

acronym: DEFISTEP

summary: The objective of this study is to assess the superiority in achieving personal goals (set by the patient and the medical team) according to the GAS scale (Goal Attainment Scaling) while wearing the carbon medical device Ankle Foot Orthosis (AFO) compared to a standard plastic ankle foot orthosis.

ReferenceType: background

ReferenceCitation: Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.

ReferenceCitation: Barreto LC, Oliveira FS, Nunes PS, de Franca Costa IM, Garcez CA, Goes GM, Neves EL, de Souza Siqueira Quintans J, de Souza Araujo AA. Epidemiologic Study of Charcot-Marie-Tooth Disease: A Systematic Review. Neuroepidemiology. 2016;46(3):157-65. doi: 10.1159/000443706. Epub 2016 Feb 6.

ReferenceCitation: Gholizadeh H, Abu Osman NA, Eshraghi A, Ali S, Razak NA. Transtibial prosthesis suspension systems: systematic review of literature. Clin Biomech (Bristol, Avon). 2014 Jan;29(1):87-97. doi: 10.1016/j.clinbiomech.2013.10.013. Epub 2013 Oct 29.

ReferenceCitation: Zucker DR, Ruthazer R, Schmid CH. Individual (N-of-1) trials can be combined to give population comparative treatment effect estimates: methodologic considerations. J Clin Epidemiol. 2010 Dec;63(12):1312-23. doi: 10.1016/j.jclinepi.2010.04.020. Epub 2010 Sep 22.

ReferenceCitation: Spieler JF, Amarenco P. [Socio-economic aspects of stroke management]. Rev Neurol (Paris). 2004 Nov;160(11):1023-8. doi: 10.1016/s0035-3787(04)71139-x. French.

lead_sponsor: Thuasne

location_facility:
CHU Lille
CHU Strasbourg
centre Louis PIERQUIN
Hôpital Rothschild


title: A Pilot Study Evaluating a Ketogenic Diet Concomitant to Nivolumab and Ipilimumab in Patients With Metastatic Renal Cell Carcinoma

acronym: KETOREIN

summary: The purpose of this study is to assess objective response rate (partial and complete response) of Nivolumab and Ipilimumab concomitant to a special diet (ketogenic diet, continuous or discontinuous) or standard diet with or without BHB according to RECIST v1.1 at 8 weeks.

design_allocation: Non-Randomized

ReferenceCitation: Dashti HM, Mathew TC, Hussein T, Asfar SK, Behbahani A, Khoursheed MA, Al-Sayer HM, Bo-Abbas YY, Al-Zaid NS. Long-term effects of a ketogenic diet in obese patients. Exp Clin Cardiol. 2004 Fall;9(3):200-5.

ReferenceCitation: Woolf EC, Scheck AC. The ketogenic diet for the treatment of malignant glioma. J Lipid Res. 2015 Jan;56(1):5-10. doi: 10.1194/jlr.R046797. Epub 2014 Feb 6.

ReferenceCitation: Chung HY, Park YK. Rationale, Feasibility and Acceptability of Ketogenic Diet for Cancer Treatment. J Cancer Prev. 2017 Sep;22(3):127-134. doi: 10.15430/JCP.2017.22.3.127. Epub 2017 Sep 30.

ReferenceCitation: Levesque S, Pol JG, Ferrere G, Galluzzi L, Zitvogel L, Kroemer G. Trial watch: dietary interventions for cancer therapy. Oncoimmunology. 2019 Apr 3;8(7):1591878. doi: 10.1080/2162402X.2019.1591878. eCollection 2019.

ReferenceCitation: Ferrere G, Tidjani Alou M, Liu P, Goubet AG, Fidelle M, Kepp O, Durand S, Iebba V, Fluckiger A, Daillere R, Thelemaque C, Grajeda-Iglesias C, Alves Costa Silva C, Aprahamian F, Lefevre D, Zhao L, Ryffel B, Colomba E, Arnedos M, Drubay D, Rauber C, Raoult D, Asnicar F, Spector T, Segata N, Derosa L, Kroemer G, Zitvogel L. Ketogenic diet and ketone bodies enhance the anticancer effects of PD-1 blockade. JCI Insight. 2021 Jan 25;6(2):e145207. doi: 10.1172/jci.insight.145207.

ReferenceCitation: Motzer RJ, Tannir NM, McDermott DF, Aren Frontera O, Melichar B, Choueiri TK, Plimack ER, Barthelemy P, Porta C, George S, Powles T, Donskov F, Neiman V, Kollmannsberger CK, Salman P, Gurney H, Hawkins R, Ravaud A, Grimm MO, Bracarda S, Barrios CH, Tomita Y, Castellano D, Rini BI, Chen AC, Mekan S, McHenry MB, Wind-Rotolo M, Doan J, Sharma P, Hammers HJ, Escudier B; CheckMate 214 Investigators. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277-1290. doi: 10.1056/NEJMoa1712126. Epub 2018 Mar 21.

oa_colors: green other

evidence: open (via free article)

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Tampere University - Tampere University Institutional Repository

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

version: submittedVersion

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

repositories_institution: Ghent University - Ghent University Academic Bibliography

repositories_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repositories_institution: Tampere University - Tampere University Institutional Repository

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Motzer RJ, Rini BI, McDermott DF, Aren Frontera O, Hammers HJ, Carducci MA, Salman P, Escudier B, Beuselinck B, Amin A, Porta C, George S, Neiman V, Bracarda S, Tykodi SS, Barthelemy P, Leibowitz-Amit R, Plimack ER, Oosting SF, Redman B, Melichar B, Powles T, Nathan P, Oudard S, Pook D, Choueiri TK, Donskov F, Grimm MO, Gurney H, Heng DYC, Kollmannsberger CK, Harrison MR, Tomita Y, Duran I, Grunwald V, McHenry MB, Mekan S, Tannir NM; CheckMate 214 investigators. Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended follow-up of efficacy and safety results from a randomised, controlled, phase 3 trial. Lancet Oncol. 2019 Oct;20(10):1370-1385. doi: 10.1016/S1470-2045(19)30413-9. Epub 2019 Aug 16. Erratum In: Lancet Oncol. 2019 Aug 21;: Lancet Oncol. 2020 Jun;21(6):e304. Lancet Oncol. 2020 Nov;21(11):e518.

repositories_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

ReferenceCitation: Gianchecchi E, Fierabracci A. Inhibitory Receptors and Pathways of Lymphocytes: The Role of PD-1 in Treg Development and Their Involvement in Autoimmunity Onset and Cancer Progression. Front Immunol. 2018 Oct 17;9:2374. doi: 10.3389/fimmu.2018.02374. eCollection 2018.

ReferenceCitation: Chemnitz JM, Parry RV, Nichols KE, June CH, Riley JL. SHP-1 and SHP-2 associate with immunoreceptor tyrosine-based switch motif of programmed death 1 upon primary human T cell stimulation, but only receptor ligation prevents T cell activation. J Immunol. 2004 Jul 15;173(2):945-54. doi: 10.4049/jimmunol.173.2.945.

ReferenceCitation: Lazar-Molnar E, Scandiuzzi L, Basu I, Quinn T, Sylvestre E, Palmieri E, Ramagopal UA, Nathenson SG, Guha C, Almo SC. Structure-guided development of a high-affinity human Programmed Cell Death-1: Implications for tumor immunotherapy. EBioMedicine. 2017 Mar;17:30-44. doi: 10.1016/j.ebiom.2017.02.004. Epub 2017 Feb 6.

ReferenceCitation: Doherty JR, Cleveland JL. Targeting lactate metabolism for cancer therapeutics. J Clin Invest. 2013 Sep;123(9):3685-92. doi: 10.1172/JCI69741. Epub 2013 Sep 3.

ReferenceCitation: Allen BG, Bhatia SK, Anderson CM, Eichenberger-Gilmore JM, Sibenaller ZA, Mapuskar KA, Schoenfeld JD, Buatti JM, Spitz DR, Fath MA. Ketogenic diets as an adjuvant cancer therapy: History and potential mechanism. Redox Biol. 2014;2:963-70. doi: 10.1016/j.redox.2014.08.002. Epub 2014 Aug 7.

ReferenceCitation: Aykin-Burns N, Ahmad IM, Zhu Y, Oberley LW, Spitz DR. Increased levels of superoxide and H2O2 mediate the differential susceptibility of cancer cells versus normal cells to glucose deprivation. Biochem J. 2009 Feb 15;418(1):29-37. doi: 10.1042/BJ20081258.

ReferenceCitation: Zhou Z, Hagopian K, Roberts M, et al. A Ketogenic Diet Increases Markers of Mitochondrial Content in a Tissue Specific Manner in Adult Mice. FASEB J. 2017;31(1_supplement):lb482-lb482. doi:10.1096/fasebj.31.1_supplement.lb482

ReferenceCitation: Stafford P, Abdelwahab MG, Kim DY, Preul MC, Rho JM, Scheck AC. The ketogenic diet reverses gene expression patterns and reduces reactive oxygen species levels when used as an adjuvant therapy for glioma. Nutr Metab (Lond). 2010 Sep 10;7:74. doi: 10.1186/1743-7075-7-74.

ReferenceCitation: Cavaleri F, Bashar E. Potential Synergies of beta-Hydroxybutyrate and Butyrate on the Modulation of Metabolism, Inflammation, Cognition, and General Health. J Nutr Metab. 2018 Apr 1;2018:7195760. doi: 10.1155/2018/7195760. eCollection 2018.

ReferenceCitation: Kimura I, Inoue D, Maeda T, Hara T, Ichimura A, Miyauchi S, Kobayashi M, Hirasawa A, Tsujimoto G. Short-chain fatty acids and ketones directly regulate sympathetic nervous system via G protein-coupled receptor 41 (GPR41). Proc Natl Acad Sci U S A. 2011 May 10;108(19):8030-5. doi: 10.1073/pnas.1016088108. Epub 2011 Apr 25.

ReferenceCitation: Rahman M, Muhammad S, Khan MA, Chen H, Ridder DA, Muller-Fielitz H, Pokorna B, Vollbrandt T, Stolting I, Nadrowitz R, Okun JG, Offermanns S, Schwaninger M. The beta-hydroxybutyrate receptor HCA2 activates a neuroprotective subset of macrophages. Nat Commun. 2014 May 21;5:3944. doi: 10.1038/ncomms4944.

ReferenceCitation: Youm YH, Nguyen KY, Grant RW, Goldberg EL, Bodogai M, Kim D, D'Agostino D, Planavsky N, Lupfer C, Kanneganti TD, Kang S, Horvath TL, Fahmy TM, Crawford PA, Biragyn A, Alnemri E, Dixit VD. The ketone metabolite beta-hydroxybutyrate blocks NLRP3 inflammasome-mediated inflammatory disease. Nat Med. 2015 Mar;21(3):263-9. doi: 10.1038/nm.3804. Epub 2015 Feb 16.

ReferenceCitation: Shimazu T, Hirschey MD, Newman J, He W, Shirakawa K, Le Moan N, Grueter CA, Lim H, Saunders LR, Stevens RD, Newgard CB, Farese RV Jr, de Cabo R, Ulrich S, Akassoglou K, Verdin E. Suppression of oxidative stress by beta-hydroxybutyrate, an endogenous histone deacetylase inhibitor. Science. 2013 Jan 11;339(6116):211-4. doi: 10.1126/science.1227166. Epub 2012 Dec 6.

ReferenceCitation: Xie G, Zhou Q, Qiu CZ, Dai WK, Wang HP, Li YH, Liao JX, Lu XG, Lin SF, Ye JH, Ma ZY, Wang WJ. Ketogenic diet poses a significant effect on imbalanced gut microbiota in infants with refractory epilepsy. World J Gastroenterol. 2017 Sep 7;23(33):6164-6171. doi: 10.3748/wjg.v23.i33.6164.

ReferenceCitation: Braun S, Bitton-Worms K, LeRoith D. The link between the metabolic syndrome and cancer. Int J Biol Sci. 2011;7(7):1003-15. doi: 10.7150/ijbs.7.1003. Epub 2011 Aug 16.

ReferenceCitation: Tracz AF, Szczylik C, Porta C, Czarnecka AM. Insulin-like growth factor-1 signaling in renal cell carcinoma. BMC Cancer. 2016 Jul 12;16:453. doi: 10.1186/s12885-016-2437-4.

ReferenceCitation: Hakimi AA, Reznik E, Lee CH, Creighton CJ, Brannon AR, Luna A, Aksoy BA, Liu EM, Shen R, Lee W, Chen Y, Stirdivant SM, Russo P, Chen YB, Tickoo SK, Reuter VE, Cheng EH, Sander C, Hsieh JJ. An Integrated Metabolic Atlas of Clear Cell Renal Cell Carcinoma. Cancer Cell. 2016 Jan 11;29(1):104-116. doi: 10.1016/j.ccell.2015.12.004.

ReferenceCitation: Zhang X, Tang N, Hadden TJ, Rishi AK. Akt, FoxO and regulation of apoptosis. Biochim Biophys Acta. 2011 Nov;1813(11):1978-86. doi: 10.1016/j.bbamcr.2011.03.010. Epub 2011 Mar 31.

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repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repositories_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

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lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Hôpital Foch
Gustave Roussy
Hôpitaux Cochin-Port-Royal
Hôpital Européen Georges Pompidou


title: INterest of the Negative Predictive Value of Integrons in Choosing a Narrow-spectrum Empirical anTibiotic Treatment vs Usual Empirical Antibiotic Treatment for Urinary Tract infectionS in the PEDiatric Emergency Department

acronym: INVICTUS PED

summary: INVICTUS PED primary objective is to show the non-inferiority of an empirical antibiotic therapeutic management guided by the early detection of integrons in the urine, compared to a usual empirical antibiotic treatment, for the recovery of children admitted to the pediatric emergency department (ED) with a non-severe urinary tract infection (UTI) with fever

primary_purpose: Basic Science

lead_sponsor: University Hospital, Limoges

location_facility:
Limoges university Hospital
Bordeaux university Hospital
Toulouse university Hospital
Montpellier university Hospital

intervention_type: Procedure

region: Nouvelle-Aquitaine

nom_etablissement: CHU  DE  LIMOGES

acronyme: INVICTUS PED

titre: INtérêt de la Valeur prédictive des Intégrons dans le Choix d'une anTibiothérapie probabilisteà spectre réduit vs traitement empirique pour le traitement des infections Urinaires fébrilesaux urgenceS PEDiatriques : essai contrôlé randomisé de non-infériorité.

discipline_principale: pédiatrie, infectiologie antibiothérapie probabiliste , biomarqueur , infections urinaires , résistance , urgences pédiatriques

nom_porteur: LAGUILLE

prenom_porteur: Christine


title: Effectiveness of Percutaneous A1 Pulley Release Under Ultrasound Guidance Associated With Infiltration, Versus Infiltration Alone, in Patients With Trigger Finders Who Have Failed a First Infiltration: a Randomized Controlled Trial

acronym: SECOIA

summary:
Trigger finger is a mechanical problem characterized by pain and catching of digit in flexion.

Histological changes of A1 pulley and synovial proliferation have been identified as factors that prompt trigger finger The first-line treatment of trigger finger is conservative with splinting and corticosteroid injection.

If the first infiltration fails, either a second infiltration or surgical sectioning of the pulley is proposed.

Surgery can be performed by several techniques (open section, percutaneous section with palpatory guidance, or under ultrasound guidance).

Percutaneous A1 pulley release under ultrasound guidance consists of cutting the A1 pulley by a percutaneous insertion with small needle under local anaesthesia.

The hypothesis of the study is that percutaneous A1 pulley release under ultrasound guidance followed by a corticosteroid injection would be more effective than a second corticosteroid injection alone on complete resolution of the trigger finger symptoms

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
Hopital Lariboisière
CHU Nantes
CHD Vendée
Hopital Henri Mondor


title: Relationship Between Resistance to the Tyrosine Kinase Inhibitor Osimertinib and Pharmacokinetics in Non-small Cell Lung Cancer: Toward an Individualization of the Treatment (RESISTYR)

acronym: RESISTYR

summary:
Osimertinib is a tyrosine kinase (TKI) inhibitor targeting EGF-R (epidermal growth factor receptor) and used in the management of patients with non-small cell lung cancer (NSCLC) with oncogenic drug addiction to EGF-R. The results of the FLAURA study justifies this 3rd generation TKI as the first line TKI of choice since an increase in overall survival of several months has been observed compared to TKIs of previous generations (erlotinib, gefitinib). However, the response to osimertinib is heterogeneous and some patients are poor responder. In addition, even when an initial response to ITK is observed, the natural history of the disease inevitably leads to the appearance of resistance mutations and loss of efficacy of osimertinib after a few months of treatment.In the hypothesis of a concentration-effect relationship, an underexposure (an insufficient plasma concentration) to osimertinib could lead to a suboptimal response by favoring the appearance of molecular resistance. By analogy with the mechanisms of resistance to anti-infectives, the systemic concentration of TKI may have to be maintained above a certain value throughout the treatment to reach an effective concentration in the tumor, in order to to prevent the selection of resistant clones. The value of this approach for optimizing treatment with TKI has been shown for this therapeutic class. This mechanistic hypothesis has been suggested several TKIs.

In addition, the association between pharmacokinetics of TKIs and the development of resistance has been reported in several pilot studies for dasatinib, erlotinib. Furthermore, a link between TKI concentration and ctDNA concentration was demonstrated in a pilot study by Garlan et al. in 11 patients treated for melanoma with vemurafenib.

The impact of the results of this study is important since the aims are to identify preemptive and predictive biomarkers of drug response and to increase mechanistic knowledge regarding risk factor of resistance to osimertinib. Finally, if the hypotheses evaluated in this translational research study are verified, therapeutic drug monitoring of TKI (and ctDNA analysis) would be immediately applicable in clinical practice since the technical tools are already available in the laboratories of most hospitals centers.

time_perspective: Prospective

ipd_sharing: Undecided

lead_sponsor: Rennes University Hospital

location_facility:
CH Saint Malo (Service de Pneumologie)
Chu de Rennes (Service Pneumologie)
CH Bretagne Sud (Site du Scorff)
CH Bretagne Atlantique

intervention_type: Diagnostic Test


title: Optical Genome Mapping in Hematological Malignancies

acronym: CARTOGEN

summary: Establish the diagnostic potential of optical genome mapping in patients with suspected hematologic cancer

time_perspective: Retrospective

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CH Morlaix, service d'hémato clinique
CH St Brieuc, service d'hémato clinique
CHRU de Brest
CHIC, service d'hémato clinique


title: Post Market Clinical Follow-up of Dual-mobility Acetabular Cup EUROSCUP MOBILE

summary:
EUROSCUP MOBILE is intended for use in primary and revision total hip replacement surgery.

Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

As part of post market vigilance, EUROS will collect data on EUROSCUP MOBILE performances and safety

location_facility:
Clinique Montagard
Clinique montagard
CHU Gabriel Montpied
Hôpital Saint Joseph-Saint Luc


title: Mechanisms fo Clopidogrel Resistance in Older Adults

acronym: CEPAGE

summary: A clopidogrel resistance rate of 40-50% has been found in the population over 70 years of age, whereas biological resistance, associated with an increased risk of cardiovascular events, is observed in about 20-30% of younger patients. One hypothesis is that the active metabolite is less available in resistant patients. Indeed, 85% of the absorbed clopidogrel undergoes inactivation by esterases. Then the remaining fraction undergoes two steps of metabolisation to the active thiol metabolite by CYP450, essentially the isoform 2C19. In older adults, increased esterase activity and/or decreased CYP450 2C19 activity may lead to a decreased concentration of the active metabolite. Multiple chronic conditions and polypharmacy encountered in older individuals are associated with basal platelet hyperactivity, and may also contribute to a poor response to clopidogrel. No data on the relationship between platelet response and circulating metabolite levels, or on the determinants of response to clopidogrel, are currently available in the geriatric population. Therefore, we propose to analyse the relationship between age and platelet and extra-platelet mechanisms potentially involved in the variability of response to clopidogrel.

location_facility:
CHU de RENNES
Hôpital Lariboisière
Hôpital Charles Foix
Hôpital Européen Georges Pompidou,

intervention_type: Biological


title: Evaluation of the Relevance of Pharmacogenetics in the Prescription Off Antidepressants in a Military Population

acronym: PSYGEN

summary:
The treatment of depression, anxiety disorders and post-traumatic stress disorder (PTSD) is a main public health problem due to the frequency of these pathologies and the very partial effectiveness of the existent therapies. These illnesses generally require the prescription of several successive lines of antidepressant treatments before the treatments actually become effective, leading to a several week delay during which the patient suffers from the symptoms of his/her pathology and is also likely to experience the side effects of the treatment.

Pharmacogenetics is an individualized prescribing modality that aims to predict the most favorable treatment for a given individual based on the study of genetic variants of cytochromes.

The main hypothesis of this research is that the use of pharmacogenetics in routine practice in a population of military personnel requiring a first prescription of an antidepressant is of interest to improve the tolerance and effectiveness of the treatment.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Laveran

location_facility: Hôpital d'Instruction des Armées Sainte-Anne


title: Randomized Phase II Study of Neoadjuvant Chemotherapy Plus Retifanlimab (INCMGA00012) in Patients With Selected Sarcomas

acronym: TORNADO

summary: Multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trial to assess the antitumor activity of retifanlimab (INCMGA00012) in association with neoadjuvant chemotherapy

lead_sponsor: Institut Bergonié

sponsor_collaborators:
Institut Bergonié
Incyte Biosciences International Sàrl

location_facility:
Institut Gustave Roussy
Institut Bergonié
Centre Léon Bérard
Institut Curie


title: The Arginine Vasopressin aXis as a Potential Therapeutic Target for Posterior REverSible Encephalopathy SyndromE (XPRESSE)

acronym: XPRESSE

summary:
XPRESSE is a multicenter observational prospective biomarker study in which critically ill patients with MRI-based PRES diagnosis will have copeptin kinetics from a daily blood sample for 6 days and a 3-month follow-up. This study aims to investigate the relationship between copeptin and PRES in order to establish the optimal therapeutic time window for vaptan treatment against PRES.

Data collection using an electronic case report form will include demographic data, medical history and data related to PRES: onset modalities and date of symptoms control, radiological features of PRES, biological investigations, results of etiological investigations and therapeutic management (e.g., anticonvulsants, antihypertensive drugs, supportive treatments). Outcomes will include modified Rankin scale score and Glasgow Outcome Scale score at ICU discharge, 3-month modified Rankin Scale score and 3-month mortality.

lead_sponsor: University Hospital, Tours

location_facility:
University hospital
Hospital


title: Prevalence of Atrial Fibrillation in Cryptogenic Stroke With Patent Foramen Ovale Closure (PFO-AF) Study

acronym: PFO-AF

summary: This study aims to assess the incidence of atrial fibrillation (AF), documented using data recorded by an implantable Holter monitoring device (Reveal Linq, Medtronic) within 2 years after percutaneous closure of patent foramen ovale for cryptogenic stroke.

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon

location_facility:
University Hospital Besancon
CHU Dijon
CHU Grenoble
CHU Lyon - Hôpital Louis Pradel


title: Physical Fitness Impact of Early Physiotherapy Intervention With a Standardized Exercise Therapy Program in Adult Patients Receiving Intensive Induction Chemotherapy for Treatment of Acute Leukemia During Extended Hospitalization. Randomized Controlled Superiority Trial in Parallel Arms, Multicentric (KinHémo)

acronym: KinHémo

summary: This study aimed to investigate the impact of Physical therapy in adult patients receiving intensive induction chemotherapy for the treatment of acute leukemia during prolonged hospitalization. The study cohort included 150 patients. Primary objective is to compare the effect of a standardized rehabilitation program on physical deconditioning. This study has several secondary objectives of comparing and analyzing the status of sarcopenia, muscle strength, physical performance and the psychic dimension of this intervention. The 6 minutes walking test, Handgrip strength, impedance measurement, computed tomography, Short Physical Performance were used as measures of physical function. Hospital Anxiety and Depression Scale and European Organization for the Research and Treatment of Cancer-Quality of Life-Questionnaire-30 (EORTC-QLQ-30) were used as measures of depression and anxiety and quality of life of cancer patients. To investigate the impact of physical therapy, patients were assigned to the physical therapy group (experimental group) or the control group.These results will thus make it possible to promote access to physiotherapy and rehabilitation care, from diagnosis and during hospitalization, and to standardize practices.

lead_sponsor: University Hospital, Angers

location_facility:
CHU Tours
CHU Brest
CHU Nantes
CHU Angers

appel_a_projets: PHRIP

region: Pays de la Loire

nom_etablissement: CHR ANGERS

acronyme: KinHémo

titre: KinHémo  Impact sur la condition physique d'une intervention kinésithérapique précoce avec un programme standardisé de thérapie par l'exercice chez les patients adultes recevant une chimiothérapie intensive d'induction pour le traitement d'une leucémie aiguë lors d'une hospitalisation prolongée. Essai contrôlé randomisé multicentrique.

discipline_principale: médecine physique et réadaptation

nom_porteur: BARETTE LEFIEUX

prenom_porteur: Amélie


title: Study of the Acceptability and Psychosocial Impact of Using a Telepresence Robot in the Living Space of Inpatients

acronym: ROBOLINK-e

summary: This study focuses on the mobile robot assist device for tele-interaction: the "COVEALINK 2" robot. This telepresence robot is designed for remote use inside the home. It works with an Internet connection (Wifi or 4G). It consists of a control interface (an application installed on the smartphone or tablet of the hospitalized patient) and a mobile robot placed in the home of the hospitalized patient (composed of a mobile platform, a visualization screen whose tilt is adjustable remotely for better adaptation to the interlocutors and an audio communication system). From the app installed on his smartphone or tablet, the patient hospitalized in the center for a long time (2 months minimum) will be able to start remotely (from the center where he is hospitalized) the robot and have it move within his home to communicate with the people present at the time of use (family, friends, neighbors etc.).

lead_sponsor: Association APPROCHE

collaborators:
LP3C, University of Rennes 2
COVEA

sponsor_collaborators:
Association APPROCHE
LP3C, University of Rennes 2
COVEA

location_facility:
CMRRF de Kerpape
CMPR Côte d'Amour
IUR Clémenceau
CR Mulhouse


title: Suicide Risk Within 30 Days After a Potentially Traumatic Event (PTE) in Patients Treated by a Medico-psychological Emergency Unit. Prospective Cohort Study

acronym: SCAR

summary:
The national french survey "Mental health in general population", showed that the risk of suicide was significantly increased during exposure to a potentially traumatic event (PTE), with an increasing gradient depending on the psychological impact. This included not only people suffering from post-traumatic stress disorder but also those confronted with PTE, presenting or having presented phenomena of reviviscence or at least an element of psychopathological impact. This risk could concern 30.2% of the population over the entire lifetime. Internationally, recent reviews of the literature tend to show that victims of interpersonal violence are more at risk of suicide (OR 1.99 95% CI: 1.73-2.28). Nevertheless, the literature remains heterogeneous, the definitions vague and the temporal proximity of the violence little taken into account. It is therefore a large-scale phenomenon that remains little explored.

To increase our knowledge in this area, the investigators will focus on patients treated by Emergency Medical Psychological Cells (CUMP), that is victims of disasters, accidents involving a large number of victims or events that may have significant psychological repercussions due to the circumstances surrounding them.

lead_sponsor: University Hospital, Grenoble

location_facility:
Geneste-Saelens
COURVOISIER Pierre
VIGNAUD Philippe
DELACHENAL Catherine


title: Training in Shared Decision-making of Cystic Fibrosis Centers Competences in the Treatment of CF Related Diabetes in Adult Patients: a Qualitative Evaluation of the Implementation

acronym: FORAIDMUCO

summary:
Diabetes affects half of cystic fibrosis patients aged 30 years and older. It develops asymptomatically for a long time. Also, two options are possible: start insulin treatment now with the additional constraints associated with cystic fibrosis or wait while monitoring the patient's clinical status and initiate insulin treatment when he has developed symptoms and therefore later. In practice, the choice between these two options takes place over two medical consultations without a formalized shared decision-making process between the doctor and the patient.

Shared decision-making is a decision-making process in which the healthcare provider and the patient learn about patients care options and then deliberate to reach a common agreement on the decision taken.

Shared decision-making seemed particularly relevant to us in cystic fibrosis where there are complex treatment options with variable short-, medium- and long-term side effects and where the disease and its treatments have a high impact on the patient's quality of life.

status: Unknown status

lead_sponsor: Hospices Civils de Lyon

location_facility: CRCM Montpellier Mixte - Hôpital Arnaud de Villeneuve

location_facility: CRCM Rennes adulte - Hôpital Pontchaillou

location_facility: CRCM Lyon adulte - Centre hospitalier Lyon Sud

location_facility: CRCM Grenoble adulte - Hôpital Albert Michallon

status_simplified: Unknown


title: CUTADIAB OBSERVATORY Investigation of the Skin Manifestations Associated With the Adhesives of Technological Tools for Diabetes

acronym: CUTADIAB

summary: The use of technological tools in the treatment of diabetes has intensified and become common in recent years. Many of these systems adhere to the skin with an adhesive in place between 2 and 14 days. The objective of this study is to determine the prevalence and consequences of skin reactions to skin adhesive systems for the treatment of diabetes.

status: Completed

study_completion_date_type: Actual

time_perspective: Cross-Sectional

enrollment_type: Actual

ReferenceCitation: Diedisheim M, Pecquet C, Julla JB, Carlier A, Potier L, Hartemann A, Jacqueminet S, Vidal-Trecan T, Gautier JF, Dubois Laforgue D, Fagherazzi G, Roussel R, Larger E, Sola-Gazagnes A, Riveline JP. Prevalence and Description of the Skin Reactions Associated with Adhesives in Diabetes Technology Devices in an Adult Population: Results of the CUTADIAB Study. Diabetes Technol Ther. 2023 Apr;25(4):279-286. doi: 10.1089/dia.2022.0513. Epub 2023 Feb 24.

publisher_dissemination: Mary Ann Liebert Inc

location_facility: AP-HP, Bichat Hospital, Department of Diabetology, Endocrinology and Nutrition

location_facility: AP-HP, Cochin Hospital, Department of Diabetology

location_facility: AP-HP, Lariboisière Hospital, Department of Diabetes and Endocrinology

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Diabetes and Metabolic Diseases Department

status_simplified: Completed


title: "Imaging With 68Ga-DOTA-peptides and Peptide Receptor Radionuclide Therapy With 177Lu-DOTA-peptides of Gastroenteropancreatic Neuroendocrine Tumors: Interest of Intra-arterial Hepatic Infusion in Patients With Dominant Liver Metastases"

acronym: LUTARTERIAL

summary: The management of liver metastases in neuroendocrine neoplasms is challenging. Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs (SSA) is one of the most promising therapeutic options. As liver is the most frequent site of metastatic disease, our project proposes to compare administration of radiolabeled SSA by arterial intrahepatic infusion (experimental approach) vs intravenous administration (conventional). Evaluation will be made by (i) comparing 68Ga-DOTA-peptides uptake after intra-hepatic versus intravenous route (imaging), (ii) by evaluating the safety of an additional intra-hepatic administration of therapeutic radiolabeled SSA (therapy).

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Advanced Accelerator Applications

location_facility: Institut universitaire du cancer de Toulouse (IUCT) Oncopole

location_facility: Institut de cancérologie du Gard (ICG) - CHU de Nîmes

nom_etablissement: CHU DE BORDEAUX

acronyme: LUTARTERIAL

titre: Radiothérapie interne vectorisée des tumeurs neuro-endocrines par analogues radiomarqués de la somatostatine : évaluation de l'intérêt d'une administration par voie intra-artérielle hépatique chez les patients avec métastases hépatiques dominantes.

discipline_principale: cancer médecine nucléaire

nom_porteur: TLILI

prenom_porteur: Ghoufrane


title: Evaluation of Effect and Tolerance of the Association of Baricitinib (4 mg) and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo: a Randomized, Double-blind, Prospective, Non-comparative Phase II Study.

acronym: BARVIT

summary: The purpose of this phase 2 study is to evaluate the effect and the safety of the combination of Baricitinib in combination with phototherapy in adult participants with non-segmental progressive vitiligo.

location_facility: Service de dermatologie - Hôpital Henri Mondor - EA EpiDermE (Epidémiologie en Dermatologie et Evaluation des Thérapeutiques)

location_facility: Service de dermatologie Centre de Référence des Maladies Rares de la Peau et des muqueuses d'origine génétique - Hôpital Larrey

location_facility: Service de Dermatologie - Hôpital Saint-André

location_facility: Centre Hospitalier Universitaire de Nice - Service de Dermatologie


title: Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease

acronym: ONDELA

summary: Investigation of the effect of Low-intensity extracorporeal shockwave therapy (ESWT) for Peyronie's disease (PD) via a single blind, sham-controlled, randomized clinical trial. Investigators will not be blinded to group assignments, but penile curvature will be assessed from coded patient pictures by a blinded assessor.

lead_sponsor: Hopital Foch

sponsor_collaborators:
Hopital Foch
Dornier MedTech Systems

location_facility:
Hôpital Rangueil
Centre d'Urologie du Polygone
Hôpital Pasteur 2
Foch hospital

nom_etablissement: HOPITAL FOCH

type_etablissement: EBNL

acronyme: ONDELA

titre: Sécurité et efficacité de la thérapie par ONDE de chocs à faible intensité pour la maladie de LA Peyronie (ONDELA)

discipline_principale: urologie

nom_porteur: LEBRET

prenom_porteur: Thierry


title: Effectiveness and Acceptability of a Digital Solution to Train Specific EEG Frequencies With Neurofeedback for Improving Sleep

acronym: CONNECTOSOM

summary: The management of insomnia includes, as a first step, a healthy lifestyle, including physical activity at appropriate times, nutritional monitoring, reduced consumption of stimulants, bedtime and wake-up times that do not vary between weekdays and weekends, banning screens at least two hours before bedtime, etc. If all these conditions are met and insomnia persists, additionnal therapies may be offered. URGOTECH has developed a connected headband allowing to practice neurofeedback in complete autonomy in subjects reporting dissatisfaction with the quality of their sleep.

lead_sponsor: URGOTECH

collaborators:
Urgotech
University Hospital, Grenoble

sponsor_collaborators:
URGOTECH
Urgotech
University Hospital, Grenoble

location_facility:
Pellegrin University Hospital
Lille University Hospital
Hôpital Hôtel-Dieu - APHP
Grenoble Alpes University Hospital


title: Randomized Trial for Unstable Pediatric Crohn's Disease Patients Comparing the Use of Crohn's Disease Exclusion Diet (CDED) on Top of Standard Therapy Versus Standard Therapy Alone.

acronym: ASCENSION

summary: This research is a multicenter French randomized and single blinded phase III clinical trial evaluating two treatment strategies among Crohn's disease (CD) patients. The main objective is to assess if the addition of Crohn's Disease Exclusion Diet (CDED) to ongoing standard medication is superior to reduce the rate of relapses over 12 months compared to standard medication alone in children/adolescents with unstable CD responding with remission after a 2-months course of CDED

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

ReferenceCitation: Wynands J, Belbouab R, Candon S, Talbotec C, Mougenot JF, Chatenoud L, Schmitz J, Cezard JP, Goulet O, Hugot JP, Ruemmele FM. 12-month follow-up after successful infliximab therapy in pediatric crohn disease. J Pediatr Gastroenterol Nutr. 2008 Mar;46(3):293-8. doi: 10.1097/MPG.0b013e31815604cd.

ReferenceCitation: Pigneur B, Lepage P, Mondot S, Schmitz J, Goulet O, Dore J, Ruemmele FM. Mucosal Healing and Bacterial Composition in Response to Enteral Nutrition Vs Steroid-based Induction Therapy-A Randomised Prospective Clinical Trial in Children With Crohn's Disease. J Crohns Colitis. 2019 Jul 25;13(7):846-855. doi: 10.1093/ecco-jcc/jjy207.

ReferenceCitation: Levine A, Wine E, Assa A, Sigall Boneh R, Shaoul R, Kori M, Cohen S, Peleg S, Shamaly H, On A, Millman P, Abramas L, Ziv-Baran T, Grant S, Abitbol G, Dunn KA, Bielawski JP, Van Limbergen J. Crohn's Disease Exclusion Diet Plus Partial Enteral Nutrition Induces Sustained Remission in a Randomized Controlled Trial. Gastroenterology. 2019 Aug;157(2):440-450.e8. doi: 10.1053/j.gastro.2019.04.021. Epub 2019 Jun 4.

ReferenceCitation: Levine A, Sigall Boneh R, Wine E. Evolving role of diet in the pathogenesis and treatment of inflammatory bowel diseases. Gut. 2018 Sep;67(9):1726-1738. doi: 10.1136/gutjnl-2017-315866. Epub 2018 May 18.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
MICALIS Institute

location_facility: Hôpital de la Timone, AP-HM - Service de Gastroentérologie pédiatrique

location_facility: CHU Caen Normandie - Service de Gastroentérologie pédiatrique

location_facility: Hôpital Femme mère enfant, CHU Lyon - Service Hépato-gastroentérologie et Nutrition pédiatrique

location_facility: Hôpital Necker-Enfants malades - Service de Gastroentérologie pédiatrique

intervention_type: Dietary Supplement

acronyme: ASCENSION

titre: Etude randomisée comparant l'ajout de la Crohn's Disease Exclusion Diet (CDED) on top d'un traitement standard versus un traitement standard seul chez les patients pédiatriques atteints d'une maladie de Crohn instable

discipline_principale: pédiatrie

nom_porteur: RUEMMELE

prenom_porteur: Frank


title: Prognostic Value of the Bradykinin-degradating Enzymes Activities on the Relapse Risk of Angiotensin-Converting Enzyme Inhibitors-associated Angioedema

acronym: KIN-ACE

summary:
Angiotensin-Converting-Enzyme-inhibitors-dependent angioedema (ACEi-AE) is the most frequent form of bradykinin-mediated AE, with an estimated prevalence of 0.1% to 0.7%.

These AE can be explained by the accumulation of bradykinin (BK), a peptide responsible for increase of vascular permeability: ACE inhibitors block ACE, the main inactivation pathway of the BK, thus extending its half-life.

In spite of the the stopping of the drug, systematically performed in the case of ACEi-AE, up to 50% of patients relapsed within 6 months, with maximum risk in the first month after stopping. In addition, the discontinuation of these drugs represents a loss of chance for some patients, without clearly established mastocytic (or histaminic) or bradykinic etiology.

At present there is no method to predict the risk of crisis recurrence in patients who have developed AE-IEC.

The investigators hypothesize that the risk of relapse is associated with a decrease in the activity of BK degradation enzymes (including aminopeptidase P (APP), dipeptidyl peptidase-4 (DPP4), and ECA) that persists at the cessation of IEC.

sponsor_collaborators:
University Hospital, Grenoble
University Hospital, Paris
University Hospital, Rouen

location_facility:
CHRU de Lille _Hôpital Claude-Huriez
AP-HP _St Antoine
Chu Grenoble Alpes
CHU de Rouen

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU GRENOBLE ALPES

acronyme: KIN-ACE

titre: Détermination de la valeur pronostique des activités des enzymes du catabolisme de la bradykinine sur le risque de récidive de l'angioedème secondaire à la prise d'inhibiteur de l'enzyme de conversion de l'angiotensine

nom_porteur: DEFENDI

prenom_porteur: Fédérica


acronym: ACUITY

lead_sponsor: Oculis

summary: To evaluate the safety and tolerability of OCS-05 compared to placebo in patients with acute optic neuritis (AON) receiving the standard of care

sponsor_collaborators: Oculis Neurotrials

location_facility: CIC Neurosciences - La Pitié Salpêtrière

title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of OCS-05 in Patients With Acute Optic Neuritis


title: Clinical Evaluation of the Medical Device (MD) (Caloprothese Connected Kit, CCK)- Comprising a Sleeve and a Sock - in Amputees Suffering From Rebellious Neuropathic Pain on the Residual Limb and / or Phantom Limb

acronym: KCC

summary:
Neuropathic pain is common in limb amputees and causes reductions in activity and participation as well as impaired quality of life. Some of these pains lead to the diagnosis of a responsible lesion and to precise and effective treatments (amputation neuroma pains, for example), whether they are etiological or symptomatic. Other pains of a neuropathic character remain totally or partially resistant to symptomatic treatment. Their appearance, intensity, duration and frequency vary depending on the amputee.

Old scientific data confirmed by modern imagery indicates a process of reorganization of cortical areas by multimodal afferents. This reconstruction, coherent or not of the body diagram, is at the genesis of sensations, normal or not, in the amputee.

Early plurimodal reassignment constitutes the founding principle of the rehabilitation of amputees: tactile afferents, visual afferents, motor afferents, proprioceptive afferents. Rehabilitation techniques and early fitting contribute to this reafferentation and to the functional integration of the fitting and to the quality of life of the amputee.

Scientific work by Katz et al, and experiences of amputees relieved by the application of local heat or stay in hot climatic zones show that the thermoregulation of the residual limb could be of interest.

It has been shown that these pain conditions are often related to a reduction in superficial blood flow to the distal part of the stump. The physiological response of the body to variations in outside temperature physiologically consists in the regulation of skin temperature. The goal seems to keep the body in a so-called "thermal neutrality" zone, substantially between 30 ° C and 33 ° C, by vasodilation or vasoconstriction of the superficial blood vessels depending on exposure to cold or heat.

An innovative medical device has been developed for a regulated thermal re-afferentation of the residual limb, during and outside the wearing of the prosthesis. The Connected Caloprosthesis Kit (CCK®) includes a connected sleeve put in place when wearing the prosthesis (interface between the skin and the socket) and a connected sock to put in place outside of wearing the prosthesis. These 2 devices include an autonomous heating and regulation process, which maintains the amputation stump in the area known as "skin thermal normality". This device is non-invasive. It includes a silicone sleeve and a heating sock for femoral or tibial amputee patients equipped with an expandable textile warmer, a flexible micro-temperature sensor and a 4-conductor extensible cable connected to a thermoregulation box worn as a belt which regulates the temperature of the stumps in the thermal neutrality zone between 30 and 33°C.

In order to assess the therapeutic effect of CCK®, given the heterogeneity of the population and the small number of patients eligible for the study, the Single Case Experimental Design (multiple baselines design) seems to us to be the methodology the most suitable: the principle is to evaluate intensively and prospectively a small group of subjects, each case being its own comparator. The methodology is defined a priori including systematic observations and repeated measurements at a defined frequency before, during, or even after the intervention introduced in a sequential and randomized manner. The data analysis can be individual and therefore patient-specific, but also group with the calculation of the size of the therapeutic effect and the calculation of significance.

This design therefore makes it possible to overcome the difficulties encountered during randomized controlled trials: having to have a large number of subjects necessary to show a significant difference in the medical device and to have a homogeneous population.

This methodology is therefore not a description of a clinical case but an alternative methodology to randomized controlled trials. In fact, it is considered by the Oxford Center for Evidence-Based Medicine 2011 to be level I, like the randomized controlled trials.

The proposed clinical study therefore has a dual objective: practical as a new treatment therapy by validating this medical device and theoretical, supporting the pathogenic model of painful sensations in amputees

lead_sponsor: Gregand Innovations

sponsor_collaborators:
Gregand Innovations
Clin-Experts

location_facility: Institut Universitaire de Réadaptation Clemenceau

location_facility: Hôpital d'Instruction des Armées Percy -


title: Systemic Inflammation During Recanalization of Cerebral Arterial Occlusion

acronym: CONVASC-I

summary: Strokes management, secondary to proximal arterial occlusion, by endovascular thrombectomy (TM) is now well established. The immuno-inflammatory events of reperfusion after TM are discussed. Systemic inflammation is a major factor suggested to explain the limited recovery of the ischemic parenchyma. Understanding these phenomena is necessary before developing an immunomodulatory strategy.

location_facility: Service de Neuroradiologie interventionnelle - Hôpital Neurologique/Groupement Est

location_facility: Service d'Anesthésie Réanimation Hôpital - Neurologique/Groupement Est

location_facility: Service de Neurologie vasculaire - Hôpital Neurologique/Groupement Est

location_facility: Service d'Anesthésie Réanimation - Hôpital Edouard Herriot/Groupement Centre


title: Prospective Comparative Multicentric Study, Assess the Quality of Life and Functionnal Results After Sigmoidectomy for Diverticulitis and Cancer

acronym: SIG-QOL

summary: The aim of this present study is to compare functional results and quality of life after sigmoidectomy for diverticulitis and sigmoid cancer.

lead_sponsor: Nantes University Hospital

location_facility:
Vendée Departmental Hospital
Nantes University Hospital
Angers University Hospital
Caen University Hospital


title: Biomarkers algOrithm for strOke diagnoSis and Treatment Resistance Prediction

acronym: BOOST

summary:
Triage of acute ischemic stroke (AIS) patients is critical, to decrease time to treatment, and improve functional outcome. The therapeutic standard of care for AIS consecutive to large vessel occlusion (LVO) is the association of intravenous (IV) alteplase administration and mechanical thrombectomy (MT). However, there are limited places where MT can be performed. Therefore, there is a need for innovative tools to identify, in the ambulance, patients with LVO that require MT. Sending the patients at the right, avoiding futile stops (i.e. in places where MT is not available), is definitively a strategy that saves time.

There is currently no biomarker nor Point Of Care (POC) Lab Testing to solve this issue and clinical scoring methods such as the NIHSS have a low accuracy rate to detect LVO. The relevance of blood biomarkers for LVO diagnosis and therapeutic decisions needs to be confirmed for effective triage in the setting of AIS with LVO, which represent 30% of all AIS.

The main objective of our study is to determine diagnostic performances of a panel of selected blood biomarkers to identify patients with AIS consecutive to LVO among those with stroke suspicion, within 24 hours of stroke symptom's onset before brain imaging.

This could facilitate the triage of patients with LVO refractory to thrombolysis treatment, who may benefit most from MT.

location_facility:
Hospital Foch
Rothschild Foundation Hospital
Department Neurology Caen Hospital
Lariboisière


title: Phase II Randomized Controlled Study Aiming to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.

acronym: TEC-ORL

summary:
This study aims to compare the analgesic activity of capsaicin patch 8% applications at 3 months interval each on the cervico-facial area versus a reference neuropathic treatment with amitriptyline in patients with head and neck cancer in remission and with sequelae neuropathic pain.

In this phase II trial, patients will be assigned in one of the two treatment arms:

Arm A (Experimental arm): Capsaïcin patch (Qutenza®)

Arm B (standard arm): Amitriptyline (Laroxyl®)

130 patients will be included and will be followed during 9 months.

lead_sponsor: Institut Claudius Regaud

location_facility: INSTITUT DE CANCEROLOGIE DE L'OUEST (ICO) Site Angers

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

region: Occitanie

nom_etablissement: INSTITUT CLAUDIUS REGAUD ONCOPOLE

type_etablissement: CLCC

acronyme: TEC-ORL

titre: Phase II randomisée comparative visant à évaluer l'intérêt du Qutenza dans la prise en charge de patients en rémission de cancer ORL et présentant des douleurs neuropathiques séquellaires

discipline_principale: oncologie, néoplasies orl

nom_porteur: BODEN

prenom_porteur: Antoine


title: Can the Relative Fecal Abundance of BLSE and the Digestive Microbiota be Predictive of the Risk of Infection in a Carrier Patient?

summary:
Among Enterobacteriaceae, the production of beta-lactamases (ESBLs) is the leading cause of multi-resistance. The first cases of ESBL-producing Enterobacteriaceae (E-ESBL) infections were described in the 1980s and subsequently experienced worldwide dissemination.

Since the turn of the century, the prevalence of E-ESBL infections, especially among Escherichia coli (E. coli) and Klebsiella pneumoniae (K. pneumoniae) has increased dramatically.

The emergence of multidrug-resistant Enterobacteriaceae is currently a real public health problem. The European Antimicrobial Resistance Surveillance Network evaluated, among clinical strains, the rate of resistance to 3rd generation cephalosporins (C3G) at 9.5% for E. coli and 28% for K. pneumoniae. Numerous studies have shown that bacterial colonization is the prerequisite for the occurrence of many infections.

However, the existence of prior colonization does not seem to be the only risk factor for the occurrence of a secondary infection. Therefore, in patients with multidrug-resistant Gram-negative bacillus gastrointestinal carriage there appear to be factors associated with the onset of infection. Several studies have examined the risk factors associated with E-ESBL-related infections in both community-based and healthcare-associated / nosocomial infections. Two main risk factors seem to be associated with E-ESBL infections: prior antibiotic therapy and the existence of invasive devices.

A recent study, carried out on 1288 patients and aimed at validating a predictive score for the occurrence of ESBL-E bacteremia, demonstrated 5 factors associated with the appearance of E-ESBL-linked bacteremia. These factors were: (i) a history of colonization / infection with ESBL-E, (ii) age ≥ 43 years, (iii) recent hospitalization in a region with a high prevalence of ESBL-E, (iv) antibiotic therapy ≥ 6 days in the previous 6 months and (v) the existence of a chronic vascular access.

Recently, a retrospective case-control study conducted in the United States by Augustine et al. Suggested that 5% of cases of bacteremia were related to ESBL-E.

Few studies have looked at risk factors for infection in patients known to be colonized by the digestive system. In a retrospective case-control study, conducted outside the intensive care unit and including pediatric and adult patients, the authors identified 2 factors associated with the occurrence of Ec-ESBL infection in previously colonized patients. These two factors were the prior use of antibiotics with β-lactam antibiotics and β-lactamase inhibitor (s), and urinary catheterization.

In intensive care hospital patients, the occurrence of ESBL-producing enterobacteriaceae infection appears to be a rare event, including in colonized patients.

The work of Ruppé et al. showed a direct link between relative fecal abundance of EScher-producing Escherichia coli and prior antibiotic intake.

This work also demonstrated a link between the value of the relative fecal abundance in Ec-ESBL and the occurrence of a urinary tract infection linked to the same clone. In particular, the authors found that women with a low relative fecal abundance rate (≤ 0.1%) had no risk of developing an Escherichia coli urinary tract infection. Conversely, the risk increased with the relative fecal abundance of Escherichia coli, but with a positive predictive value limited to 57% for relative fecal abundances between 10 and 100%.

primary_purpose: Diagnostic

ReferenceCitation: Wertheim HF, Vos MC, Ott A, van Belkum A, Voss A, Kluytmans JA, van Keulen PH, Vandenbroucke-Grauls CM, Meester MH, Verbrugh HA. Risk and outcome of nosocomial Staphylococcus aureus bacteraemia in nasal carriers versus non-carriers. Lancet. 2004 Aug 21-27;364(9435):703-5. doi: 10.1016/S0140-6736(04)16897-9.

ReferenceCitation: Bruyere R, Vigneron C, Bador J, Aho S, Toitot A, Quenot JP, Prin S, Charles PE. Significance of Prior Digestive Colonization With Extended-Spectrum beta-Lactamase-Producing Enterobacteriaceae in Patients With Ventilator-Associated Pneumonia. Crit Care Med. 2016 Apr;44(4):699-706. doi: 10.1097/CCM.0000000000001471.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Dubinsky-Pertzov B, Temkin E, Harbarth S, Fankhauser-Rodriguez C, Carevic B, Radovanovic I, Ris F, Kariv Y, Buchs NC, Schiffer E, Cohen Percia S, Nutman A, Fallach N, Klausner J, Carmeli Y; R-GNOSIS WP4 Study Group. Carriage of Extended-spectrum Beta-lactamase-producing Enterobacteriaceae and the Risk of Surgical Site Infection After Colorectal Surgery: A Prospective Cohort Study. Clin Infect Dis. 2019 May 2;68(10):1699-1704. doi: 10.1093/cid/ciy768.

publisher_dissemination: Oxford University Press

ReferenceCitation: Zahar JR, Lesprit P, Ruckly S, Eden A, Hikombo H, Bernard L, Harbarth S, Timsit JF, Brun-Buisson C; BacterCom Study Group. Predominance of healthcare-associated cases among episodes of community-onset bacteraemia due to extended-spectrum beta-lactamase-producing Enterobacteriaceae. Int J Antimicrob Agents. 2017 Jan;49(1):67-73. doi: 10.1016/j.ijantimicag.2016.09.032. Epub 2016 Nov 16. Erratum In: Int J Antimicrob Agents. 2017 Apr;49(4):480-481.

ReferenceCitation: Rodriguez-Bano J, Navarro MD, Retamar P, Picon E, Pascual A; Extended-Spectrum Beta-Lactamases-Red Espanola de Investigacion en Patologia Infecciosa/Grupo de Estudio de Infeccion Hospitalaria Group. beta-Lactam/beta-lactam inhibitor combinations for the treatment of bacteremia due to extended-spectrum beta-lactamase-producing Escherichia coli: a post hoc analysis of prospective cohorts. Clin Infect Dis. 2012 Jan 15;54(2):167-74. doi: 10.1093/cid/cir790. Epub 2011 Nov 4.

ReferenceCitation: Goodman KE, Lessler J, Cosgrove SE, Harris AD, Lautenbach E, Han JH, Milstone AM, Massey CJ, Tamma PD; Antibacterial Resistance Leadership Group. A Clinical Decision Tree to Predict Whether a Bacteremic Patient Is Infected With an Extended-Spectrum beta-Lactamase-Producing Organism. Clin Infect Dis. 2016 Oct 1;63(7):896-903. doi: 10.1093/cid/ciw425. Epub 2016 Jun 28.

evidence: open (via free pdf)

ReferenceCitation: Augustine MR, Testerman TL, Justo JA, Bookstaver PB, Kohn J, Albrecht H, Al-Hasan MN. Clinical Risk Score for Prediction of Extended-Spectrum beta-Lactamase-Producing Enterobacteriaceae in Bloodstream Isolates. Infect Control Hosp Epidemiol. 2017 Mar;38(3):266-272. doi: 10.1017/ice.2016.292. Epub 2016 Dec 19.

publisher_dissemination: Cambridge University Press

lead_sponsor: Fondation Hôpital Saint-Joseph

location_facility:
Hôpital Avicenne
Groupe Hospitalier Paris Saint-Joseph
Centre Hospitalier Sud-Francilien
Hôpital Necker-Enfants malades


title: Natural History Study of Usher Syndrome in a Cohort of Patients Followed Longitudinally for 5 Years

summary: Clinical centres in the LIGHT4DEAF consortium have developed and will continue to improve a reliable, early molecular diagnosis and protocols for full clinical characterisation of Usher syndrome, which will be valuable for the foreseen USH clinical trials. The clinical arm of the project aims at performing a deep-phenotyping of retinal degeneration, hearing loss, vestibular dysfunction, neurocognitive ability of subects with a molecular diagnosis of any Usher syndrome. Functional and structural parameters for retinal, auditory, and vestibular impairments are followed overtime to document the natural history of the disease and establish relevant clinical endpoint for disease progression that may be useful for future clinical trials.

lead_sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts


title: Early Remote Intervention in Autism: a Randomized Noninferiority Clinical Trial Comparing Semi-intensive Early Start Denver Model (ESDM) Intervention With Remote Parental Training/ Supervision Versus Intensive ESDM Intervention.

acronym: IPAAD

summary:
The Early Start Denver Model (ESDM) has shown its efficiency in the early management of ASD.

The study aims to evaluate the efficiency of a new type of management based on a semi-intensive center-based intervention (8h per week) coupled with a MOOC (Massive Online Open Course: a teaching and learning intervention based on instrumental and interactive teaching situations) for remote parental training/supervision. The goal is to determine if compared to the ESDM reference intervention (15h per week), this type of care can bring, a sufficient improvement in child development course and decreased symptoms of autism in young children, and if it could be, therefore, better suited to the needs of children and their family, bypassing the previously stated obstacles.

lead_sponsor: University Hospital, Brest

location_facility:
CH Réné-Dubos
CHU Le Havre
CHU Nantes
CH Limoges

region: Bretagne

nom_etablissement: CHRU BREST

acronyme: IPAAD

titre: Intervention Précoce en Autisme A Distance : un essai de non infériorité contrôlé randomisé comparant une prise en charge semi-intensive Early Start Denver Model (ESDM) couplée à une formation et une supervision parentale à distance versus une prise en charge ESDM intensive seule.

nom_porteur: LAVENNE

prenom_porteur: Nathalie


title: Laparoscopy and COVID-19 Contamination

acronym: LAPCOV

summary: The aim of the study is to search the presence of the SARS-COV-2 virus (COVID19) in the pneumoperitoneum of patients with a positive (or suspected) COVID19 status during a routine laparoscopy.

location_facility: AP-HP, Bicêtre Hospital, Department of Digestive and Oncological Surgery

location_facility: AP-HP, Bicêtre Hospital, Anesthesia Department

location_facility: AP-HP, Bicêtre Hospital, Urology Department

location_facility: AP-HP, Bicêtre Hospital, Gynecology department


title: Interactive Guidance Therapy With Video Feed-back of Parent and Child With Autism Spectrum Disorder

acronym: GIETSA

summary: The purpose of this study is to assess the effect of Interactive Guidance Therapy with video feed back (IGT) of parent and child with Autism Spectrum Disorder, under three years of age, using a Single Case Experimental Design (SCED) with multiple baseline across subjects, multicentric, randomized, with multiple replications, blinded scored

primary_purpose: Supportive Care

ReferenceCitation: 1. McDonough S. Interaction guidance. Treat Parent-infant Relatsh Probl Strateg Interv. 2004;79-96.

ReferenceCitation: 2. McDonough SC. Promoting positive early parent-infant relationships through interaction guidance. Child Adolesc Psychiatr Clin N Am. 1995;4(3):661-72.

ReferenceCitation: Rusconi-Serpa S, Sancho Rossignol A, McDonough SC. Video feedback in parent-infant treatments. Child Adolesc Psychiatr Clin N Am. 2009 Jul;18(3):735-51. doi: 10.1016/j.chc.2009.02.009.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Ville Evrard Hospital

location_facility:
Hôpital Saint Eloi
Hôpital Ville Evrard
Hôpital Pitié Salpétriere
Hôpital Necker Enfants Malades

acronyme: GIETSA

titre: Guidance interactive par video feed-back de dyades parents-enfants avec Trouble du Spectre Autistique

discipline_principale: psychiatrie - pédopsychiatrie - autisme

nom_porteur: OUSS

prenom_porteur: Lisa


title: Prediction of Response to Treatment With Immunotherapy + Chemotherapy in Non-Small Cell Lung Cancer

acronym: PRINCE

summary: This study seeks to evaluate a multiparametric test including 6 immunohistochemical markers (PD-L1, CD8, FoxP3, PD1, CD163, CD15) to predict the cumulative incidence of death or progression on treatment with pembrolizumab+first line chemotherapy in metastatic non-small cell lung cancer, regardless of the PD-L1 status and in the absence of ALK, ROS1 or EGFR alteration.

lead_sponsor: University Hospital, Lille

location_facility:
Hop Calmette Chu Lille
Clinique Teissier
Clcc Oscar Lambret Lille
CH Victor Provot


title: Efficacy of Nicotine in Preventing COVID-19 Infection

acronym: NICOVID-PREV

summary:
The coronavirus disease (COVID-19) epidemic represents a major therapeutic challenge. The highly contagious severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) and the long duration of the disease have led to a massive influx of patients admitted in health services and intensive care units.

According to current knowledge, there are no treatments that prevent the spread of the infection, especially in exposed populations, or the disease progression to a severe form.

Daily active smokers are infrequent among outpatients or hospitalized patients with COVID-19. Several arguments suggest that nicotine is responsible for this protective effect via the nicotinic acetylcholine receptor (nAChR).

Nicotine may inhibit the penetration and spread of the virus and have a prophylactic effect in COVID-19 infection.

However, the epidemic is progressing throughout French territory and new variants (in particular the "English B1. 1.7 variant of SARS-COV-2") much more contagious run a risk of accelerating the epidemic in the population. The anti-SARS-COV-2 vaccines recently launched (or being evaluated) represent great hope in this health crisis, but trials were only able to show their effectiveness on symptomatic forms of SARS-COV-2 infection. On the one hand, the vaccination compaign for the entire population requires many months,which leaves many unprotected subjects waiting. In addition, there is currently no evidence of a protective role of vaccines against asymptomatic forms of COVID-19 and therefore on SARS-COV-2 transmission. Finally, the nicotine patches may protect people in hight-risk areas/periods until they are vaccinated (if they accept it and are eligible for it) and in the post-vaccination weeks necessary for the effectiveness of the vaccine,which reinforces the importance of evaluating this alternative prevention strategy, in the context of the arrival of vaccines

location_facility: Groupe Hospitalier de la Région de Mulhouse Sud Alsace

location_facility: Hôpital Pitié Salpêtrière - Service de Médecine Interne


title: Evaluation Des Performances du Test Rapide antigénique Covid-19 Ag BSS Chez l'Enfant Symptomatique Dans un Service d'Urgences pédiatriques

summary: This study compares the diagnostic performance of a nasopharyngeal swab antigenic test versus the RT-PCR Covid-19 reference test performed with the AllplexTM 2019-nCoV kit (Seegene, South Korea) in symptomatic children presenting at the hospital.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre hospitalier intercommunal de Créteil


title: Survival Data and Characteristics of Finisterian Patients Treated With PARP Inhibitors for Ovarian Cancer Between 2014 and 2019. Study of Efficacy and Safety Based on Finisterian Data Compared to Data in the Literature.

acronym: BREIZH-PARPi

summary: Ovarian cancer is a relatively uncommon but serious disease. It ranks 10th for female cancers, 5th for mortality, and its origin is still imperfectly known. It has a silent history for a long time, is often diagnosed late, and the prognosis is poor with a high relapse rate. It is therefore necessary to assess and prevent the risk of relapse, in order to establish a diagnosis as early as possible, and thus set up the appropriate treatment. Poly-ADP-Ribose Polymerase (PARP) inhibitors such as OLAPARIB and NIRAPARIB are effective in maintenance to prevent the risk of relapse in patients with recurrent platinum-sensitive ovarian cancer, as proved by recent data from the medical literature. Nevertheless, there may be a difference between "real life" and clinical trial data. Thus, the objective of this cohort is to assess whether the efficacy and safety of PARP inhibitors is the same in Finistère patients as in the scientific literature.

location_facility:
CHIC
CH des pays de Morlaix
Clinique Pasteur


title: Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury

acronym: CogniSo-TC

summary:
Patients who have suffered moderate to severe traumatic brain injury (TBI) frequently develop behavioural changes, which can have deleterious consequences on interpersonal relationships, social, family and professional reintegration. They are a source of difficulties (burden) for family and friends. Social cognition covers four functions: recognition of social cues; empathy; attribution of intentions to a third party, or theory of mind; and adjustment of social behaviour according to context. This study has two parts: 1/ Evaluation, using a cognitive approach, of the different components of social cognition after moderate to severe traumatic brain injury, and of its repercussions in daily life and on family and friends.

2/ Creation of a specific re-education method for the different modules of social cognition and study of its effectiveness.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

location_facility:
Ueros Ugecam
FAM la vie devant soi
Raymond Poincaré Hospital
SAMSAH-UEROS Arceau Anjou


title: Early Detection of Prostate Cancer by Liquid Biopsy

acronym: PROLIPSY

summary:
This study is the early detection of prostate cancer by analysing circulating bloodbased biomarkers. Based on our latest developments, we primarily aim to assess the validity of CTCs (circulating tumour cells) and tumour cell products circulating in blood (DNA, exosomes) for early PCa (Prostate cancer) detection.

In the first discovery period, the investigators will assess which Liquid biopsy marker will provide the best discrimination between the patients with histologically proven PCa and age-matched noncancer controls. Further subset analysis with special emphasis on the identification of high risk PCa patients with aggressive tumours as defined by a Gleason score ("gold standard") of 8 or higher (ISUP 4 and higher), will be performed. The resulting biomarker candidates will then be further explored in the subsequent training and validation study (years 2 and 3) in order to obtain the single blood test or combination of tests with the highest sensitivity and specificity for detection of early PCa and/or high-risk PCa. The investigators will also compare these new biomarkers with recently FDA cleared CE-IVD assays for early detection of prostate cancer, based on classic peripheral tumour markers, such as Prostate Health Index (PHI) and PCA3. Follow up evaluations will be initiated to assess the prognostic relevance of the candidate biomarkers determined in this project. Here, the investigators will set up the data management system including all relevant information on the tissues collected and the results of the analyses as well as the clinical data of the patients investigated in this study.

lead_sponsor: University Hospital, Montpellier

location_facility: CHU Montpellier - Département d'urologie et transplantation rénale

location_facility: CHU Montpellier - Laboratoire des Cellules Circulantes Rares Humaines

location_facility: CHU de Nîmes - Service Urologie Andrologie Sexologie

location_facility: Clinique Beau Soleil - Service d'urologie