title: Imaging of Intracerebral Inflammation in the Progressive Phase of Multiple Sclerosis

acronym: INFLASEP

summary: In this study we plan to image the compartmentalized inflammation in MS using molecular imaging by positron emission tomography (PET) with a very highly resolutive camera. Two tracers will be studied and compared: i) [18F]DPA-714, which bind to the peripheral benzodiazepine receptor (PBR), a target mainly expressed by activated microglial cells. This new ligand for PBR displays several advantages compared to the existing reference compound PK11195 in term of brain entrance, signal to noise ratio, and radiolabelling possibility with [18F] ii) [18F]-fluoro-desoxy-glucose ([18F]FDG), which should reflect glucose metabolism in activated immune cells in the white matter. Progressive MS patients (secondary progressive and primary progressive) will be compared to relapsing-remitting patients and to healthy volunteers. All subjects will pass a complete neurological evaluation and a multimodal MRI to document clinical disability and tissue injury. A clinical and radiological follow up will then be performed for a 2-year period. This study should help to understand the contribution of the intracerebral inflammation on the progression of disability and could provide a surrogate marker for further therapeutic trials in chronic progressive MS.

ReferenceCitation: García-Lorenzo D, Lavisse S, Leroy C, Wimberley C, Bodini B, Remy P, Veronese M, Turkheimer F, Stankoff B, Bottlaender M. Validation of an automatic reference region extraction for the quantification of [(18)F]DPA-714 in dynamic brain PET studies. J Cereb Blood Flow Metab. 2018 Feb;38(2):333-346. doi: 10.1177/0271678X17692599. Epub 2017 Feb 9.

name: Sorbonne Université, UPMC Paris 06, Institut du Cerveau et de la Moelle Epinière, ICM, Hôpital de la Pitié Salpêtrière, Paris, France

family: García-Lorenzo

full_name: Daniel García-Lorenzo

given: Daniel

name: Commissariat à l'Energie Atomique et aux Energies Alternatives (CEA), Département de Recherche Fondamentale (DRF), Institut d'Imagerie Biomédicale (I2BM), MIRCen, Fontenay-aux-Roses, France

name: Centre National de la Recherche Scientifique (CNRS), Université Paris-Sud, Université Paris-Saclay, Neurodegenerative Diseases Laboratory, Fontenay-aux-Roses, France

family: Lavisse

full_name: Sonia Lavisse

given: Sonia

name: Commissariat à l'Energie Atomique et aux Energies Alternatives (CEA), Département de Recherche Fondamentale (DRF), Institut d'Imagerie Biomédicale (I2BM), Service Hospitalier Frédéric Joliot, Orsay, France

name: Imagerie Moléculaire in Vivo, IMIV, CEA, Inserm, CNRS, Univ. Paris-Sud, Université Paris Saclay, Orsay, France

family: Leroy

full_name: Claire Leroy

family: Wimberley

full_name: Catriona Wimberley

given: Catriona

family: Bodini

full_name: Benedetta Bodini

given: Benedetta

name: Centre Expert Parkinson, Neurologie, CHU Henri Mondor, Assistance Publique Hôpitaux de Paris and Université Paris-Est, Créteil, France

family: Remy

full_name: Philippe Remy

given: Philippe

name: Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK

family: Veronese

full_name: Mattia Veronese

given: Mattia

family: Turkheimer

full_name: Federico Turkheimer

given: Federico

name: Hôpital Saint Antoine, AP-HP, Paris, France

family: Stankoff

full_name: Bruno Stankoff

given: Bruno

name: Commissariat à l'Energie Atomique et aux Energies Alternatives (CEA), Département de Recherche Fondamentale (DRF), Institut d'Imagerie Biomédicale (I2BM),Neurospin, UNIACT, Gif-sur-Yvette, France

family: Bottlaender

full_name: Michel Bottlaender

given: Michel

journal_name: Journal of Cerebral Blood Flow & Metabolism

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

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: Validation of an automatic reference region extraction for the quantification of [18F]DPA-714 in dynamic brain PET studies

location_facility:
Saint Antoine Hospital
Pitie Salpetriere Hospital


title: Effects of Pulmonary Rehabilitation on Self-esteem in Patients With COPD

acronym: ESMOI

summary: the aim of this study is to evaluate the evolution of self-esteem during a pulmonary rehabilitation program, in COPD patients.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Fox, K.R. et Corbin, C.B.The Physical Self-Perception Profile : Devlopment and Preliminary Validation. Journal of Sport and Exercise Psychology, 11(4), p. 408 430, 1989

ReferenceCitation: Ninot G, Moullec G, Desplan J, Prefaut C, Varray A. Daily functioning of dyspnea, self-esteem and physical self in patients with moderate COPD before, during and after a first inpatient rehabilitation program. Disabil Rehabil. 2007 Nov 30;29(22):1671-8.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CH Pays de Morlaix
CHRU de Brest

lead_sponsor_type: academique

status_simplified: Completed


design_allocation: Randomized

intervention_type: Drug

status: Recruiting

study_type: Interventional

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

lead_sponsor: UNICANCER

enrollment_type: Anticipated

primary_purpose: Treatment

acronym: AMBRE

location_facility:
Centre Eugène Marquis
Centre Hospitalier Lyon Sud

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: Open-label, Randomized, Multicenter, Phase III Study, Comparing Standard Chemotherapy to Standard Combination of Endocrine Therapy With Abemaciclib as Initial Metastatic Treatment Among Patients With Visceral Metastasis of ER+ HER2-breast Cancer, High Burden Disease

summary: AMBRE is a phase III study comparing two standard treatments as initial metastatic treatment in ER+/HER2- breast cancer (BC) patients with visceral metastasis and high burden disease: Chemotherapy and combination of endocrine therapy with abemaciclib.

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: Consumption of New Psychoactive Substances in Intoxicated Patients During the Winter Activities

acronym: SKI-Tox

summary: The purpose of this research is to identify the New Psychoactive Substances (NPS) that are responsible for intoxicating patients in ski resort during winter activities.

ReferenceCitation: Rivera JV, Vance EG, Rushton WF, Arnold JK. Novel Psychoactive Substances and Trends of Abuse. Crit Care Nurs Q. 2017 Oct/Dec;40(4):374-382. doi: 10.1097/CNQ.0000000000000174. Review.

ReferenceCitation: Yang F-S, Chen C-J, Lin Y-C. "Zombie" Outbreak Caused by Synthetic Cannabinoid. N Engl J Med. 2017 Apr 20;376(16):1596-7. doi: 10.1056/NEJMc1701936.

ReferenceCitation: Frank RG, Pollack HA. Addressing the Fentanyl Threat to Public Health. N Engl J Med. 2017 Feb 16;376(7):605-607. doi: 10.1056/NEJMp1615145.

ReferenceCitation: Khaled SM, Hughes E, Bressington D, Zolezzi M, Radwan A, Badnapurkar A, Gray R. The prevalence of novel psychoactive substances (NPS) use in non-clinical populations: a systematic review protocol. Syst Rev. 2016 Nov 21;5(1):195.

ReferenceCitation: Kunst LE, Gebhardt WA. Prevalence and Psychosocial Correlates of Party-Drug Use and Associated Problems among University Students in the Netherlands. Subst Use Misuse. 2018 Oct 15;53(12):2077-2088. doi: 10.1080/10826084.2018.1455700. Epub 2018 Apr 18.

ReferenceCitation: Palamar JJ, Barratt MJ, Ferris JA, Winstock AR. Correlates of new psychoactive substance use among a self-selected sample of nightclub attendees in the United States. Am J Addict. 2016 Aug;25(5):400-7. doi: 10.1111/ajad.12403. Epub 2016 Jul 15.

ReferenceCitation: Ridpath A, Driver CR, Nolan ML, Karpati A, Kass D, Paone D, Jakubowski A, Hoffman RS, Nelson LS, Kunins HV; Centers for Disease Control and Prevention (CDC). Illnesses and deaths among persons attending an electronic dance-music festival - New York City, 2013. MMWR Morb Mortal Wkly Rep. 2014 Dec 19;63(50):1195-8.

ReferenceCitation: Fox J, Smith A, Yale A, Chow C, Alaswad E, Cushing T, Monte AA. Drugs of Abuse and Novel Psychoactive Substances at Outdoor Music Festivals in Colorado. Subst Use Misuse. 2018 Jun 7;53(7):1203-1211. doi: 10.1080/10826084.2017.1400067. Epub 2017 Nov 17.

ReferenceCitation: Liakoni E, Dolder PC, Rentsch KM, Liechti ME. Presentations due to acute toxicity of psychoactive substances in an urban emergency department in Switzerland: a case series. BMC Pharmacol Toxicol. 2016 May 26;17(1):25. doi: 10.1186/s40360-016-0068-7.

ReferenceCitation: Palamar JJ, Salomone A, Gerace E, Di Corcia D, Vincenti M, Cleland CM. Hair testing to assess both known and unknown use of drugs amongst ecstasy users in the electronic dance music scene. Int J Drug Policy. 2017 Oct;48:91-98. doi: 10.1016/j.drugpo.2017.07.010. Epub 2017 Aug 12.

ReferenceCitation: Miliano C, Margiani G, Fattore L, De Luca MA. Sales and Advertising Channels of New Psychoactive Substances (NPS): Internet, Social Networks, and Smartphone Apps. Brain Sci. 2018 Jun 29;8(7). pii: E123. doi: 10.3390/brainsci8070123. Review.

ReferenceCitation: Robach P, Trebes G, Lasne F, Buisson C, Méchin N, Mazzarino M, de la Torre X, Roustit M, Kérivel P, Botré F, Bouzat P. Drug Use on Mont Blanc: A Study Using Automated Urine Collection. PLoS One. 2016 Jun 2;11(6):e0156786. doi: 10.1371/journal.pone.0156786. eCollection 2016.

ReferenceCitation: Orsini J, Din N, Elahi E, Gomez A, Rajayer S, Malik R, Jean E. Clinical and epidemiological characteristics of patients with acute drug intoxication admitted to ICU. J Community Hosp Intern Med Perspect. 2017 Sep 19;7(4):202-207. doi: 10.1080/20009666.2017.1356189. eCollection 2017 Oct.

ReferenceCitation: Helander A, Bäckberg M, Hultén P, Al-Saffar Y, Beck O. Detection of new psychoactive substance use among emergency room patients: results from the Swedish STRIDA project. Forensic Sci Int. 2014 Oct;243:23-9. doi: 10.1016/j.forsciint.2014.02.022. Epub 2014 Mar 6.

ReferenceCitation: Spiller HA, Ryan ML, Weston RG, Jansen J. Clinical experience with and analytical confirmation of "bath salts" and "legal highs" (synthetic cathinones) in the United States. Clin Toxicol (Phila). 2011 Jul;49(6):499-505. doi: 10.3109/15563650.2011.590812.

ReferenceCitation: Beck O, Franzén L, Bäckberg M, Signell P, Helander A. Toxicity evaluation of α-pyrrolidinovalerophenone (α-PVP): results from intoxication cases within the STRIDA project. Clin Toxicol (Phila). 2016 Aug;54(7):568-75. doi: 10.1080/15563650.2016.1190979.

ReferenceCitation: Bäckberg M, Beck O, Hultén P, Rosengren-Holmberg J, Helander A. Intoxications of the new psychoactive substance 5-(2-aminopropyl)indole (5-IT): a case series from the Swedish STRIDA project. Clin Toxicol (Phila). 2014 Jul;52(6):618-24. doi: 10.3109/15563650.2014.920088. Epub 2014 Jun 4.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Grenoble

location_facility:
CH Albertville Moutiers
University Hospital Grenoble

intervention_type: Other


title: Falls With Fracture : Role of Cognitive Disorders and Comparison With Bone Fragility

acronym: CFC

summary: The purpose of this study is to determine whether cognitive disorders are a risk factor for a fracture after a fall independently of a bone fragility.

design_allocation: Non-Randomized

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Langeard A, Pothier K, Chastan N, Marcelli C, Chavoix C, Bessot N. Reduced gait and postural stability under challenging conditions in fallers with upper limb fracture. Aging Clin Exp Res. 2019 Apr;31(4):483-489. doi: 10.1007/s40520-018-0992-z. Epub 2018 Jul 4.

family: Langeard

full_name: Antoine Langeard

given: Antoine

sequence: first

family: Pothier

full_name: Kristell Pothier

given: Kristell

sequence: additional

family: Chastan

full_name: Nathalie Chastan

given: Nathalie

family: Marcelli

full_name: Christian Marcelli

given: Christian

family: Chavoix

full_name: Chantal Chavoix

given: Chantal

family: Bessot

full_name: Nicolas Bessot

given: Nicolas

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Aging Clinical and Experimental Research

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Langeard A, Pothier K, Morello R, Lelong-Boulouard V, Lescure P, Bocca ML, Marcelli C, Descatoire P, Chavoix C. Polypharmacy Cut-Off for Gait and Cognitive Impairments. Front Pharmacol. 2016 Aug 31;7:296. doi: 10.3389/fphar.2016.00296. eCollection 2016.

family: Morello

full_name: Remy Morello

given: Remy

family: Lelong-Boulouard

full_name: Véronique Lelong-Boulouard

given: Véronique

family: Lescure

full_name: Pascale Lescure

given: Pascale

family: Bocca

full_name: Marie-Laure Bocca

given: Marie-Laure

family: Descatoire

full_name: Pablo Descatoire

given: Pablo

currency_apc_doaj: USD

journal_name: Frontiers in Pharmacology

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: Le Centre pour la Communication Scientifique Directe - HAL - memSIC


title: PRevention of INteractions Between Phytotherapies and CancEr Treatments by a SmartphonE/Tablet Automated SurvEy

acronym: PRINCESSE

summary: The use of phytotherapies or specific food or dietary supplement (HFDS) is common among cancer patients. They can also be responsible of clinically relevant interaction with anti-cancer treatments. This study aims at assessing the proportion patients using HFDS which are likely to have an interaction with their anticancer treatments. The data is collected through a smartphone/tablet application. The aim of the study is to demonstrate that clinically significant herb-drug interaction with anticancer treatment could be avoid using these devices.

status: Unknown status

time_perspective: Cross-Sectional

lead_sponsor: Paul Gougis

location_facility: Centre d'Investigation Clinique Paris-Est

status_simplified: Unknown


title: Prevalence of Primary Aldosteronism Among Hypertensive Patients Younger Than 65 Years Old With Atrial Arythmia

acronym: HAPAA

summary:
Atrial arrhythmia is the most frequent cardiac arrhythmia. It is a source of significant morbidity.

Hypertension is a major risk factor for atrial arrhythmias. Primary hyperaldosteronism (PA) is a common cause of secondary hypertension, associated with a high prevalence of arrhythmias with a specific, sometimes curative, treatment. The purpose of the study is to show that the prevalence of PA among hypertensive patients under 65 years old with atrial arrhythmia is high, justifying systematic screening.

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Centre Hospitalier de PAU

location_facility:
CHU de Bordeaux
CH de Pau

intervention_type: Diagnostic Test


title: Evaluation of Safety and Performance of the Atalante System With Patients With Lower Limb Paralysis

summary:
The study is a prospective, open, bicentric and observational study. It is conducted to assess the safety and performance of the Atalante exoskeleton system with patients with lower limb paralysis.

The principal objective is to assess the performance of the Atalante system in performing ambulatory functions with motor complete SCI patients characterized by the success rate in performing a 10mWT at the last session of training with the Atalante system.

primary_purpose: Other

lead_sponsor: Wandercraft

location_facility: Centre mutualiste de Rééducation et de Réadaptation de Kerpape

intervention_type: Device


title: Determination of Microbiological Factors Associated With Poor Response to Neoadjuvant Therapy in Rectal Cancers: Focus on Cyclomodulin-producing Escherichia Coli

acronym: MICARE

summary: The objective of this project is to determine in a non-invasive manner (fecal samples) the predictive value of the intestinal microbiota and the presence of genotoxin-producing bacteria on the response to neoadjuvant treatment in rectal cancer. This could lead to a better understanding and selection of patients for personalized treatment in rectal cancer.

ReferenceCitation: Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum in: CA Cancer J Clin. 2020 Jul;70(4):313.

ReferenceCitation: Gérard JP, André T, Bibeau F, Conroy T, Legoux JL, Portier G, Bosset JF, Cadiot G, Bouché O, Bedenne L; Société Française de Chirurgie Digestive (SFCD), Société Française d'Endoscopie Digestive (SFED0), Société Française de Radiothérapie Oncologique (SFRO). Rectal cancer: French Intergroup clinical practice guidelines for diagnosis, treatments and follow-up (SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO). Dig Liver Dis. 2017 Apr;49(4):359-367. doi: 10.1016/j.dld.2017.01.152. Epub 2017 Jan 20.

ReferenceCitation: van Gijn W, Marijnen CA, Nagtegaal ID, Kranenbarg EM, Putter H, Wiggers T, Rutten HJ, Påhlman L, Glimelius B, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 12-year follow-up of the multicentre, randomised controlled TME trial. Lancet Oncol. 2011 Jun;12(6):575-82. doi: 10.1016/S1470-2045(11)70097-3. Epub 2011 May 17.

ReferenceCitation: Sauer R, Becker H, Hohenberger W, Rödel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40.

ReferenceCitation: Dworak O, Keilholz L, Hoffmann A. Pathological features of rectal cancer after preoperative radiochemotherapy. Int J Colorectal Dis. 1997;12(1):19-23.

ReferenceCitation: Habr-Gama A, Perez RO, Nadalin W, Sabbaga J, Ribeiro U Jr, Silva e Sousa AH Jr, Campos FG, Kiss DR, Gama-Rodrigues J. Operative versus nonoperative treatment for stage 0 distal rectal cancer following chemoradiation therapy: long-term results. Ann Surg. 2004 Oct;240(4):711-7; discussion 717-8.

ReferenceCitation: Renehan AG, Malcomson L, Emsley R, Gollins S, Maw A, Myint AS, Rooney PS, Susnerwala S, Blower A, Saunders MP, Wilson MS, Scott N, O'Dwyer ST. Watch-and-wait approach versus surgical resection after chemoradiotherapy for patients with rectal cancer (the OnCoRe project): a propensity-score matched cohort analysis. Lancet Oncol. 2016 Feb;17(2):174-183. doi: 10.1016/S1470-2045(15)00467-2. Epub 2015 Dec 17.

ReferenceCitation: Rullier E, Rouanet P, Tuech JJ, Valverde A, Lelong B, Rivoire M, Faucheron JL, Jafari M, Portier G, Meunier B, Sileznieff I, Prudhomme M, Marchal F, Pocard M, Pezet D, Rullier A, Vendrely V, Denost Q, Asselineau J, Doussau A. Organ preservation for rectal cancer (GRECCAR 2): a prospective, randomised, open-label, multicentre, phase 3 trial. Lancet. 2017 Jul 29;390(10093):469-479. doi: 10.1016/S0140-6736(17)31056-5. Epub 2017 Jun 7.

family: Rullier

full_name: Eric Rullier

given: Eric

family: Rouanet

full_name: Philippe Rouanet

family: Tuech

full_name: Jean-Jacques Tuech

given: Jean-Jacques

family: Valverde

full_name: Alain Valverde

given: Alain

family: Lelong

full_name: Bernard Lelong

given: Bernard

family: Rivoire

full_name: Michel Rivoire

family: Faucheron

full_name: Jean-Luc Faucheron

given: Jean-Luc

family: Jafari

full_name: Mehrdad Jafari

given: Mehrdad

family: Portier

full_name: Guillaume Portier

given: Guillaume

family: Meunier

full_name: Bernard Meunier

family: Sileznieff

full_name: Igor Sileznieff

given: Igor

family: Prudhomme

full_name: Michel Prudhomme

family: Marchal

full_name: Frédéric Marchal

given: Frédéric

family: Pocard

full_name: Marc Pocard

given: Marc

family: Pezet

full_name: Denis Pezet

given: Denis

full_name: Anne Rullier

given: Anne

family: Vendrely

full_name: Véronique Vendrely

family: Denost

full_name: Quentin Denost

given: Quentin

family: Asselineau

full_name: Julien Asselineau

given: Julien

family: Doussau

full_name: Adélaïde Doussau

given: Adélaïde

journal_name: The Lancet

ReferenceCitation: Rouanet P, Rullier E, Lelong B, Maingon P, Tuech JJ, Pezet D, Castan F, Nougaret S; and the GRECCAR Study Group. Tailored Treatment Strategy for Locally Advanced Rectal Carcinoma Based on the Tumor Response to Induction Chemotherapy: Preliminary Results of the French Phase II Multicenter GRECCAR4 Trial. Dis Colon Rectum. 2017 Jul;60(7):653-663. doi: 10.1097/DCR.0000000000000849.

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Savage DC. Microbial ecology of the gastrointestinal tract. Annu Rev Microbiol. 1977;31:107-33. Review.

ReferenceCitation: Nougayrède JP, Taieb F, De Rycke J, Oswald E. Cyclomodulins: bacterial effectors that modulate the eukaryotic cell cycle. Trends Microbiol. 2005 Mar;13(3):103-10. Review.

ReferenceCitation: Nougayrède JP, Homburg S, Taieb F, Boury M, Brzuszkiewicz E, Gottschalk G, Buchrieser C, Hacker J, Dobrindt U, Oswald E. Escherichia coli induces DNA double-strand breaks in eukaryotic cells. Science. 2006 Aug 11;313(5788):848-51.

ReferenceCitation: Bonnet M, Buc E, Sauvanet P, Darcha C, Dubois D, Pereira B, Déchelotte P, Bonnet R, Pezet D, Darfeuille-Michaud A. Colonization of the human gut by E. coli and colorectal cancer risk. Clin Cancer Res. 2014 Feb 15;20(4):859-67. doi: 10.1158/1078-0432.CCR-13-1343. Epub 2013 Dec 13.

ReferenceCitation: Buc E, Dubois D, Sauvanet P, Raisch J, Delmas J, Darfeuille-Michaud A, Pezet D, Bonnet R. High prevalence of mucosa-associated E. coli producing cyclomodulin and genotoxin in colon cancer. PLoS One. 2013;8(2):e56964. doi: 10.1371/journal.pone.0056964. Epub 2013 Feb 14.

ReferenceCitation: Roy S, Trinchieri G. Microbiota: a key orchestrator of cancer therapy. Nat Rev Cancer. 2017 May;17(5):271-285. doi: 10.1038/nrc.2017.13. Epub 2017 Mar 17. Review.

ReferenceCitation: Villéger R, Lopès A, Veziant J, Gagnière J, Barnich N, Billard E, Boucher D, Bonnet M. Microbial markers in colorectal cancer detection and/or prognosis. World J Gastroenterol. 2018 Jun 14;24(22):2327-2347. doi: 10.3748/wjg.v24.i22.2327. Review.

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

location_facility: Institut régional du Cancer de Montpellier


title: A Phase II Study Evaluating AGuIX® Nanoparticles in Combination With Stereotactic Radiation for Oligo Brain Metastases.

acronym: NANOSTEREO

summary: This study evaluates the clinical impact of AGuIX® nanoparticles in combination with Fractionated Stereotactic Radiation in oligo brain metastases.

status: Terminated

lead_sponsor: Centre Leon Berard

location_facility:
Centre Antoine Lacassagne
Centre Léon Bérard


title: Randomized Prospective Study Evaluating the Benefit of the Treatment of the Distal Amputation Sequelae of the Fingers by Lipofilling - LIPOFILLING Study

acronym: LIPOFILLING

summary: The purpose of this study is to evaluate the contribution of autologous graft reinjection (lipofilling) in the treatment of dysaesthesic pulp.

location_facility:
CH de Cornouaille - Quimper
CHRU de Brest


title: Observatory on Different Artificial Labour-induction Methods and Measuring Immediate Postpartum Maternal Satisfaction

acronym: SATISFACC

summary:
Our hypothesis is that there is one sequence of labour-induction that leads to a better experience of childbirth than others. This is based on the following underlying theories :

Maternal satisfaction depends on the number of labour-inducing sequences
A longer labour-induction would be experienced less positively than a shorter one
The experience is correlated with maternal outcomes ( vaginal / Caesarian delivery, spontaneous birth or instrument-assisted birth, maternal complications ) and neonatal outcomes (neonatal complications, secondary hospitalization).

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU Arnaud de Villeneuve Service de Gynécologie Obstétrique


title: OCT-angiography as a Pronostic Marker for Visual Impairment in Patients Undergoing Neurosurgery for Compressive Macroadenoma : a Prospective Study.

acronym: FIRST

summary: The aim of the study is to assess accurancy of OCT angiography as a pronostic marker for patients undergoing neurosurgery for compressiver macroadenoma as compared with visual acuity, visual field and OCT.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Hôpital Pasteur 2 - Service d'Ophtalmologie

intervention_type: Procedure


title: Prediction of the Risk of Biochemical Relapse After Radical Prostatectomy for Prostate Cancer Using Radomics on Pre-therapeutic MRI

acronym: PREBOP

summary:
With 50% of post-operative biochemical failure, efficient predictive models are needed to guide post-operative management.

Radiomic features are quantitative features extracted from medical imaging, supposed to be correlated with tumor heterogeneity.

We aim to build and test three predictive models (clinical, radiomic and combined models).

time_perspective: Retrospective

location_facility:
Centre Hospitalier de Cornouaille
CHRU de Brest


title: Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura

acronym: APAM

summary: Recent data suggest involvement of Acid-Sensing Ion Channel channels in the pathophysiology of migraine making these channels a therapeutic target of migraine disease. The implication of Acid-Sensing Ion Channels is discussed through Acid-Sensing Ion Channel-1 which is the most expressed Acid-Sensing Ion Channel channel subtype in the central nervous system. In a mouse model, cortical spreading depression is inhibited by different Acid-Sensing Ion Channel blockers including amiloride which is a non-selective blocker of the Acid-Sensing Ion Channel-1 channel. From a translational perspective, an efficacy of amiloride on a series of migraine patients suffering from severe aura in open conditions. The APAM study is a proof-of-concept study that aims to evaluate the effect of amiloride in the prophylaxis of migraine with aura. This is a randomized crossover study versus placebo conducted in 3 French headache centers.

study_start_date_type: Anticipated

ReferenceCitation: Charles AC, Baca SM. Cortical spreading depression and migraine. Nat Rev Neurol. 2013 Nov;9(11):637-44. doi: 10.1038/nrneurol.2013.192. Epub 2013 Sep 17. Review.

ReferenceType: result

ReferenceCitation: Ayata C, Jin H, Kudo C, Dalkara T, Moskowitz MA. Suppression of cortical spreading depression in migraine prophylaxis. Ann Neurol. 2006 Apr;59(4):652-61.

ReferenceCitation: Ligthart L, Boomsma DI, Martin NG, Stubbe JH, Nyholt DR. Migraine with aura and migraine without aura are not distinct entities: further evidence from a large Dutch population study. Twin Res Hum Genet. 2006 Feb;9(1):54-63.

location_facility:
AP-HM
CHU de Montpellier


title: An International Multicenter Phase II Trial of Durvalumab (MEDI4736) Plus OLAparib Plus Fulvestrant in Metastatic or Locally Advanced ER-positive, HER2-negative Breast Cancer Patients Selected Using Criteria That Predict Sensitivity to Olaparib

acronym: DOLAF

summary: This study evaluates the efficacy of the combination of olaparib, durvalumab, and fulvestrant for the treatment of patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer with BRCA gene alterations or alterations of genes involved in homologous recombination repair (HRR) or microsatellite instability (MSI) status.

location_facility:
Centre Henri-Becquerel
Institut de Cancerologie de Montpellier


title: Effect of Transorbital Electrical STIMulation of Optic Nerve on Remyelination After an Acute Optic Neuritis

acronym: ONSTIM

summary:
In light of experimental models showing that neuronal electrical activity is crucial for the remyelination process, we hypothesize that maintenance of electrical axonal activity in the early stages of optic neuritis may promote myelin repair, limiting thereby axonal degeneration.

In humans, electrical stimulation of the optic nerve has been tested mainly in ischemic neuropathy and retinitis pigmentosa, which are both associated with severe axonal/retinal pathology and poor visual prognosis. In contrast, the inflammation of the optic nerve in optic neuritis is generally transient, with less severe axonal damage at the acute phase, which would allow for better efficacy of electrical stimulation as a strategy to promote remyelination and neuroprotection.In light of experimental models showing that neuronal electrical activity is crucial for the remyelination process, we hypothesize that maintenance of electrical axonal activity in the early stages of optic neuritis may promote myelin repair, limiting thereby axonal degeneration.

In humans, electrical stimulation of the optic nerve has been tested mainly in ischemic neuropathy and retinitis pigmentosa, which are both associated with severe axonal/retinal pathology and poor visual prognosis. In contrast, the inflammation of the optic nerve in optic neuritis is generally transient, with less severe axonal damage at the acute phase, which would allow for better efficacy of electrical stimulation as a strategy to promote remyelination and neuroprotection.

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

location_facility: Institut du Cerveau et de la Moelle epiniere - Hopital Pitie Salpetriere


title: In Adults With Very Unstable Type 1 Diabetes, is the DBLHU Closed-Loop Insulin Delivery System Able to Improve Blood Glycemic Control Compared to Low-Glucose-Predictive-Suspend System: Two-center, Randomized, Open-label Study

acronym: DBLHU

summary:
Feasibility study, comparing experimental treatment (DBLHU closed-loop system) with reference treatment (Low Glucose Predictive Suspend system) in 7 patients going through a series of N-of-1 trials. Each N-of-1 trial consists in a prospectively planned, multiple crossover study in a single individual. Two blocks of two periods of four weeks each (closed loop or open loop) will be conducted. Within each block, the sequence closed loop-open loop or open loop-close loop is randomized. Outcomes will be analyzed on the third and fourth weeks of period.

A remote monitoring system managed by specialized nurse on behalf of diabetologist, is provided in closed-loop session.

An extension period of 48 weeks with the DBLHU System (closed-loop condition) will be performed at the end of the crossover study phase in real life conditions (without remote monitoring).

primary_purpose: Device Feasibility

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility:
Lille University Hospital
Grenoble Alpes University Hospital


title: Validation of the Watch Withings HWA08 for the Detection of Atrial Fibrillation

acronym: MOVE-ECG

summary: The proposed clinical study aims at validating the diagnostic performance, in comparison with a reference ECG, of Withings HWA08 watch for the automatic identification of atrial fibrillation (AF).

lead_sponsor: Withings

location_facility:
Clinique AXIUM Centre de cardiologie
Centre Cardiologique du Nord


title: Comparison of Patient Work of Breathing and Tidal Volumes With High-flow Nasal Cannula Oxygen Therapy and Non-invasive Ventilation After Extubation in the ICU: a Prospective, Randomized, Controlled Study

acronym: OVNI

summary: This study is aimed at evaluating patient work of breathing and tidal volumes with three methods of oxygenation: standard oxygen, high-flow oxygen therapy and non-invasive ventilation.

ReferenceCitation: Lewis SR, Baker PE, Parker R, Smith AF. High-flow nasal cannulae for respiratory support in adult intensive care patients. Cochrane Database Syst Rev. 2021 Mar 4;3:CD010172. doi: 10.1002/14651858.CD010172.pub3.

name: Lancaster Patient Safety Research Unit; Royal Lancaster Infirmary; Lancaster UK

family: Lewis

full_name: Sharon R Lewis

given: Sharon R

name: Academic Centre; Oxford University Hospitals NHS Trust; Oxford UK

family: Baker

full_name: Philip E Baker

given: Philip E

name: Cochrane MOSS Network, c/o Cochrane Pain Palliative and Supportive Care Group; Oxford University Hospitals NHS Foundation Trust; Oxford UK

family: Parker

full_name: Roses Parker

given: Roses

name: Department of Anaesthesia; Royal Lancaster Infirmary; Lancaster UK

family: Smith

full_name: Andrew F Smith

given: Andrew F

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

license_normalized: no license

repository_institution: Queensland University of Technology - QUT ePrints

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

repository_institution: City University London - City Research Online

version: acceptedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Poitiers University Hospital

location_facility:
Intensive reanimation
CHU Poitiers


title: Place of the QuantiFERON-CMV (QF-CMV) Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis (UC)

acronym: RECOHFERRON

summary: CytoMegaloVirus (CMV) infection impairs evolution of Ulcerative Colitis (UC) leading to more severe and resistant to immunosuppressive therapies flare-up. CytoMegaloVirus (CMV) reactivation is assessed by the quantification of the CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load by real-time PCR (qPCR) in colonic biopsies; this assay is invasive and costly. The QuantiFERON-CytoMegaloVirus (QF-CMV) assay measures the immune response against CytoMegaloVirus (CMV) in a blood specimen.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
HCL-Hôpital Lyon Sud
Chu Saint-Etienne


title: Towards a Better Understanding of Neuromuscular Alterations and Fatigue in Chronic Obstructive Pulmonary Disease (COPD)

acronym: NEUROTIGUE

summary:
Fatigue is a prevalent symptom in Chronic Obstructive Pulmonary Disease (COPD) that limits patients in their daily living activities. It is now well established that COPD patients may have altered neuromuscular functions compared to healthy individuals. However, the different studies conducted on muscle fatigue in COPD have been done independently of any cognitive solicitation, yet present in most of daily living activities. Therefore, the aim of this research is to evaluate the impact of the disease on neuromuscular fatigue during dual-task situation (simultaneous accomplishment of a muscle contraction and a cognitive task). A better understanding of fatigue in COPD will promote the development of new perspectives in patient management.

The hypothesis is that COPD patients will exhibit increased fatigue level (compared to healthy subjects), particularly during dual-task situation. It is assumed that the higher negative effect associated with the dual-task will be related to different neurophysiological mechanisms (i.e., neuromuscular fatigue, autonomic nervous system activity, mental fatigue).

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Hôpital d'Instruction des Armées Sainte-Anne

location_facility: Université de Toulon, laboratoires LAMHESS et IAPS


title: Analysis of Circulating Tumor Markers in Blood

acronym: ALCINA 2

summary: The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades. The potential clinical interests of these circulating biomarkers are diagnostic, prognostic, predictive of the efficiency of targeted therapies (according to the mutational profile of the cancer), and could allow the study of the mechanisms of resistance under process. In the multiplicity of these blood potential biomarkers joins a permanent evolution of the technological means used to detect them/to quantify, as well as to estimate their clinical utility.

ReferenceCitation: Leenhardt F, Alexandre M, Guiu S, Pouderoux S, Beaujouin M, Lossaint G, Philibert L, Evrard A, Jacot W. Impact of pharmacist consultation at clinical trial inclusion: an effective way to reduce drug-drug interactions with oral targeted therapy. Cancer Chemother Pharmacol. 2021 Oct;88(4):723-729. doi: 10.1007/s00280-021-04331-0. Epub 2021 Jul 20.

family: Leenhardt

full_name: Fanny Leenhardt

given: Fanny

family: Alexandre

full_name: Marie Alexandre

given: Marie

family: Guiu

full_name: Severine Guiu

given: Severine

family: Pouderoux

full_name: Stephane Pouderoux

given: Stephane

family: Beaujouin

full_name: Melanie Beaujouin

given: Melanie

family: Lossaint

full_name: Gerald Lossaint

given: Gerald

family: Philibert

full_name: Laurent Philibert

given: Laurent

family: Evrard

full_name: Alexandre Evrard

given: Alexandre

family: Jacot

full_name: William Jacot

given: William

bso_classification: Chemistry

journal_name: Cancer Chemotherapy and Pharmacology

title: Impact of pharmacist consultation at clinical trial inclusion: an effective way to reduce drug–drug interactions with oral targeted therapy

ReferenceCitation: Leenhardt F, Gracia M, Perrin C, Muracciole-Bich C, Marion B, Roques C, Alexandre M, Firmin N, Pouderoux S, Mbatchi L, Gongora C, Jacot W, Evrard A. Liquid chromatography-tandem mass spectrometric assay for the quantification of CDK4/6 inhibitors in human plasma in a clinical context of drug-drug interaction. J Pharm Biomed Anal. 2020 Sep 5;188:113438. doi: 10.1016/j.jpba.2020.113438. Epub 2020 Jun 22.

family: Gracia

full_name: Matthieu Gracia

given: Matthieu

family: Perrin

full_name: Catherine Perrin

given: Catherine

family: Muracciole-Bich

full_name: Claudia Muracciole-Bich

given: Claudia

family: Marion

full_name: Bénédicte Marion

given: Bénédicte

family: Roques

full_name: Celine Roques

given: Celine

family: Firmin

full_name: Nelly Firmin

given: Nelly

family: Mbatchi

full_name: Litaty Mbatchi

given: Litaty

family: Gongora

full_name: Celine Gongora

journal_name: Journal of Pharmaceutical and Biomedical Analysis

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

title: Liquid chromatography–tandem mass spectrometric assay for the quantification of CDK4/6 inhibitors in human plasma in a clinical context of drug-drug interaction

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle


title: Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery

acronym: E-CTC

summary: The purpose of this study is to investigate the spread of Circulating Tumor Cells (CTC) during surgery in endometrial cancer. Although this cancer is often discovered at early stage, the risk of recurrence is estimated at 6 to 21%, according to grade. Early stage tumor is accessible for curative surgical treatment by laparoscopy but this kind of surgery may induce CTCs spread, and could be an explanation of this recurrence. Through this study, concordance between two blood punction sites, peripheral vein and ovarian vein, will be evaluated to detect these cells during surgery.

primary_purpose: Screening

lead_sponsor: University Hospital, Montpellier

location_facility:
CHU de Nîmes
Montpellier University Hospital


title: Evaluation of Functional, Neuroplastic and Biomechanical Changes Induced by an Intensive, Playful Early-morning Treatment Including Lower Limbs (EARLY-HABIT-ILE) in Preschool Children With Uni and Bilateral Cerebral Palsy

acronym: HABIT-ILE

summary:
An urgent priority in the field of paediatric neurorehabilitation is the development of effective early motor interventions.

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (= HABIT-ILE) applies the concepts of motor skill learning and intensive training to both the Upper Extremities (UE) and Lower Extremities (LE) and has been shown to improve aspects of motor function of the UE and LE in school age children with unilateral and bilateral Cerebral Palsy (CP) across the 3 levels of the International Classification of Functioning, Disability and Health (ICFDH). The principles and content of HABIT-ILE can be applied to pre-school children and this method is highly promising for early rehabilitation.

primary_purpose: Supportive Care

ReferenceCitation: Araneda R, Sizonenko SV, Newman CJ, Dinomais M, Le Gal G, Ebner-Karestinos D, Paradis J, Klöcker A, Saussez G, Demas J, Bailly R, Bouvier S, Nowak E, Guzzetta A, Riquelme I, Brochard S, Bleyenheuft Y. Protocol of changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with bilateral cerebral palsy: a multisite randomized controlled trial. BMC Neurol. 2020 Jun 12;20(1):243. doi: 10.1186/s12883-020-01820-2.

family: Araneda

full_name: Rodrigo Araneda

given: Rodrigo

family: Sizonenko

full_name: Stephane V. Sizonenko

given: Stephane V.

family: Newman

full_name: Christopher J. Newman

given: Christopher J.

family: Dinomais

full_name: Mickael Dinomais

given: Mickael

family: Le Gal

full_name: Gregoire Le Gal

given: Gregoire

family: Ebner-Karestinos

full_name: Daniela Ebner-Karestinos

given: Daniela

family: Paradis

full_name: Julie Paradis

given: Julie

family: Klöcker

full_name: Anne Klöcker

given: Anne

family: Saussez

full_name: Geoffroy Saussez

given: Geoffroy

family: Demas

full_name: Josselin Demas

given: Josselin

family: Bailly

full_name: Rodolphe Bailly

given: Rodolphe

family: Bouvier

full_name: Sandra Bouvier

given: Sandra

family: Nowak

full_name: Emmanuel Nowak

given: Emmanuel

family: Guzzetta

full_name: Andrea Guzzetta

given: Andrea

family: Riquelme

full_name: Inmaculada Riquelme

given: Inmaculada

family: Brochard

full_name: Sylvain Brochard

given: Sylvain

family: Bleyenheuft

full_name: Yannick Bleyenheuft

given: Yannick

currency_apc_doaj: GBP

journal_name: BMC Neurology

repository_institution: University of Geneva - Archive ouverte UNIGE

location_facility:
Fondation ILDYS - Site de Ty Yann
Les Capucins


title: Medico-economic Impact of Screening Atopobium Vaginae and Gardnerella Vaginalis in Molecular Biology by "Point-of-care" During Pregnancy

acronym: AuTop

summary:
Infection is the principal cause of preterm births. Most (90%) women with preterm deliveries have no abnormal history. It is widely agreed that preterm delivery is often associated with bacterial vaginosis. One of the major difficulties at this time is that the diagnosis of bacterial vaginosis is based on heterogeneous criteria. The technique currently used is the Nugent score, but it lacks the characteristics necessary for widespread use in the general population. It must be performed on a fresh swab, and any delay in transporting it can cause drying that makes the test difficult to perform.

The investigators have developed a rapid diagnostic tool for bacterial vaginosis using molecular biology based on a point of care model and obtained a patent (European Patent Office N° 2087134). In comparison with the reference techniques, our tool's performance has been excellent, in terms of specificity, sensitivity, and positive and negative predictive values. In particular, our work showed that 57% of the flora samples rated as intermediate on the Nugent score were in reality true bacterial vaginosis. Molecular biology therefore identifies a homogeneous population of women with vaginal flora anomalies. The investigators recently showed that the carriage of Atopobium vaginae and/or Gardnerella vaginalis >105/mL shortens the time to delivery in a population at risk of preterm delivery (PHRC 2006). Vaginal flora anomalies are therefore an important target for preventing preterm delivery.

ReferenceCitation: Bretelle F, Fenollar F, Baumstarck K, Fortanier C, Cocallemen JF, Serazin V, Raoult D, Auquier P, Loubière S. Screen-and-treat program by point-of-care of Atopobium vaginae and Gardnerella vaginalis in preventing preterm birth (AuTop trial): study protocol for a randomized controlled trial. Trials. 2015 Oct 19;16:470. doi: 10.1186/s13063-015-1000-y. Erratum in: Trials. 2016;17:83.

family: Bretelle

full_name: Florence Bretelle

given: Florence

family: Fenollar

full_name: Florence Fenollar

family: Baumstarck

full_name: Karine Baumstarck

given: Karine

family: Fortanier

full_name: Cécile Fortanier

given: Cécile

family: Cocallemen

full_name: Jean François Cocallemen

given: Jean François

family: Serazin

full_name: Valérie Serazin

given: Valérie

family: Raoult

full_name: Didier Raoult

given: Didier

family: Auquier

full_name: Pascal Auquier

given: Pascal

family: Loubière

full_name: Sandrine Loubière

given: Sandrine

journal_name: Trials

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

location_facility: Hôpital Nord Assistance Publique Hôpitaux de Marseille


title: Natural History Characterization in Symptomatic and Asymptomatic Progranuline Gene Mutation Carriers

acronym: Predict-PGRN

summary: The purpose of this study is to investigate whether cognitive deficits, structural and functional changes can be detected before symptom onset in presymptomatic progranuline mutation carriers. The main objectives of the project are to identify novel cognitive, brain imaging markers and peripheral biomarkers for early diagnosis of FTLD, and to follow disease progression.

ReferenceCitation: Caroppo P, Habert MO, Durrleman S, Funkiewiez A, Perlbarg V, Hahn V, Bertin H, Gaubert M, Routier A, Hannequin D, Deramecourt V, Pasquier F, Rivaud-Pechoux S, Vercelletto M, Edouart G, Valabregue R, Lejeune P, Didic M, Corvol JC, Benali H, Lehericy S, Dubois B, Colliot O, Brice A, Le Ber I; Predict-PGRN study group. Lateral Temporal Lobe: An Early Imaging Marker of the Presymptomatic GRN Disease? J Alzheimers Dis. 2015;47(3):751-9. doi: 10.3233/JAD-150270.

ReferenceCitation: Saracino D, Dorgham K, Camuzat A, Rinaldi D, Rametti-Lacroux A, Houot M, Clot F, Martin-Hardy P, Jornea L, Azuar C, Migliaccio R, Pasquier F, Couratier P, Auriacombe S, Sauvée M, Boutoleau-Bretonnière C, Pariente J, Didic M, Hannequin D, Wallon D; French Research Network on FTD/FTD-ALS; PREV-DEMALS and Predict-PGRN study groups, Colliot O, Dubois B, Brice A, Levy R, Forlani S, Le Ber I. Plasma NfL levels and longitudinal change rates in C9orf72 and GRN-associated diseases: from tailored references to clinical applications. J Neurol Neurosurg Psychiatry. 2021 Aug 4. pii: jnnp-2021-326914. doi: 10.1136/jnnp-2021-326914. [Epub ahead of print]

family: Saracino

full_name: Dario Saracino

given: Dario

family: Dorgham

full_name: Karim Dorgham

given: Karim

family: Camuzat

full_name: Agnès Camuzat

given: Agnès

family: Rinaldi

full_name: Daisy Rinaldi

given: Daisy

family: Rametti-Lacroux

full_name: Armelle Rametti-Lacroux

given: Armelle

family: Houot

full_name: Marion Houot

given: Marion

family: Clot

full_name: Fabienne Clot

given: Fabienne

family: Martin-Hardy

full_name: Philippe Martin-Hardy

given: Philippe

family: Jornea

full_name: Ludmila Jornea

given: Ludmila

family: Azuar

full_name: Carole Azuar

given: Carole

family: Migliaccio

full_name: Raffaella Migliaccio

given: Raffaella

family: Pasquier

full_name: Florence Pasquier

family: Couratier

full_name: Philippe Couratier

family: Auriacombe

full_name: Sophie Auriacombe

given: Sophie

family: Sauvée

full_name: Mathilde Sauvée

given: Mathilde

family: Boutoleau-Bretonnière

full_name: Claire Boutoleau-Bretonnière

given: Claire

family: Pariente

full_name: Jérémie Pariente

given: Jérémie

family: Didic

full_name: Mira Didic

given: Mira

family: Hannequin

full_name: Didier Hannequin

family: Wallon

full_name: David Wallon

given: David

family: Colliot

full_name: Olivier Colliot

given: Olivier

family: Dubois

full_name: Bruno Dubois

given: Bruno

family: Brice

full_name: Alexis Brice

name: the French Research Network on FTD/FTD-ALS

name: the PREV-DEMALS and Predict-PGRN study groups

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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

location_facility: Groupe Hospitalier Pitié-Salpêtrière - Charles Foix


title: A New Membrane Obturator Prothesis Concept for Soft Palate Defects

acronym: VELOMEMBRANE

summary: When soft palate defects lead to palatal insufficiency, the patient's quality of life is affected by difficulties swallowing, hypernasality, and poor intelligibility of speech. If immediate surgical reconstruction is not an option, the patient may benefit from the placement of a rigid obturator prosthesis. Unfortunately, the residual muscle stumps are often unable to adequately move this stiff and inert obturator to properly restore the velopharyngeal valve function. The objective of this case report was to describe the use of a membrane obturator prosthesis that incorporates a dental dam to compensate for the soft palate defect.

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Bordeaux
CHU de Toulouse


title: Evaluation of the Interest of PET/CT at 18F-FDG in the Post-therapeutic Management of Cervical Cancer at an Advanced Stage. Multicenter Prospective Observational Study

acronym: COLTEP

summary:
A lot of studies have demonstrated the prognostic value of post therapy 18F-FDG PET/CT in the management of uterine cervical cancer. Post therapy 18F-FDG PET/CT is usually requested by a lot of clinicians.

Whereas 18F-FDG PET/CT is useful for prognosis in the follow-up, data are yet insufficient to clearly establish a formal recommendation.

This prospective multicenter observational study will evaluate the interest of post therapy 18F-FDG PET/CT in clinical management (within 2 months of treatment) in patients with cervical cancer at an advanced stage.

Main outcome :

The therapeutic impact of post therapy 18F-FDG PET/CT (within 2 months after the end of therapy) will be evaluated on the complete results included MRI.

Investigators will compare :

decision of clinicians without 18F-FDG PET/CT results
and decision of clinicians knowing entire results included results of 18F-FDG PET/CT.

lead_sponsor: University Hospital, Brest

location_facility:
CHRU de Brest (Hôpital Morvan)
Centre Henri Becquerel


type: Registry Identifier

title: Double-blind Multicenter Phase III Trial Evaluating the Efficacy of an Oral Immunomodulatory Nutrient on Survival During Postoperative Concomitant Chemoradiotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC)

summary: The investigators designed a prospective randomized double-blind trial to determine if the oral immunomodulating formula could improve the disease-free survival rate in high-risk locally-advanced head and neck Squamous Cell Carcinoma patients treated with Chemoradiotherapy.

status: Active, not recruiting

ReferenceCitation: Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Machtay M, Ensley JF, Chao KS, Schultz CJ, Lee N, Fu KK; Radiation Therapy Oncology Group 9501/Intergroup. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44.

ReferenceCitation: Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefèbvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52.

ReferenceCitation: Machon C, Thezenas S, Dupuy AM, Assenat E, Michel F, Mas E, Senesse P, Cristol JP. Immunonutrition before and during radiochemotherapy: improvement of inflammatory parameters in head and neck cancer patients. Support Care Cancer. 2012 Dec;20(12):3129-35. doi: 10.1007/s00520-012-1444-5. Epub 2012 Mar 28.

ReferenceCitation: Vasson MP, Talvas J, Perche O, Dillies AF, Bachmann P, Pezet D, Achim AC, Pommier P, Racadot S, Weber A, Ramdani M, Kwiatkowski F, Bouteloup C. Immunonutrition improves functional capacities in head and neck and esophageal cancer patients undergoing radiochemotherapy: a randomized clinical trial. Clin Nutr. 2014 Apr;33(2):204-10. doi: 10.1016/j.clnu.2013.06.008. Epub 2013 Jun 20.

family: Vasson

full_name: M.-P. Vasson

family: Talvas

full_name: J. Talvas

given: J.

family: Perche

full_name: O. Perche

given: O.

family: Dillies

full_name: A.-F. Dillies

family: Bachmann

full_name: P. Bachmann

given: P.

family: Pezet

full_name: D. Pezet

given: D.

family: Achim

full_name: A.-C. Achim

family: Pommier

full_name: P. Pommier

family: Racadot

full_name: S. Racadot

given: S.

family: Weber

full_name: A. Weber

given: A.

family: Ramdani

full_name: M. Ramdani

given: M.

family: Kwiatkowski

full_name: F. Kwiatkowski

given: F.

family: Bouteloup

full_name: C. Bouteloup

given: C.

journal_name: Clinical Nutrition

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Immunonutrition improves functional capacities in head and neck and esophageal cancer patients undergoing radiochemotherapy: A randomized clinical trial

ReferenceCitation: De Geest S, Sabaté E. Adherence to long-term therapies: evidence for action. Eur J Cardiovasc Nurs. 2003 Dec;2(4):323.

location_facility:
Centre Léon Bérard
Institut du Cancer de Montpellier

intervention_type: Dietary Supplement


title: Evaluation of the BJI Inoplex 2 Kit for the Multiplex Serological Diagnosis of Bone and Joint Prosthetic Device Infections

summary:
A national, prospective, open-label, non-interventional, multicentre, controlled study designed to evaluate a diagnostic method in patients undergoing hip, knee or shoulder prosthetic removal regardless of whether or not infection is suspected. Serological test results will have no impact on the therapeutic approach.

Study objective: To evaluate the diagnostic performance of an antibody detection kit for the serological diagnosis of bone and joint prosthetic device infections cause by Staphylococci, Streptococci, Propionibacterium acnes (P. acnes) and Gram-negative bacteria versus the reference method: the bacterial culture of deep intraoperative samples.

lead_sponsor: Diaxonhit

location_facility: Groupe hospitalier Diaconesses Croix Saint Simon


title: Phase IV Randomized Study Evaluating Agents Stimulants Erythropoiesis (ASE) Associated With Ferric Carboxymaltose (Ferinject ®) in Concomitant or Sequential Patients Treated for Cancer and With Anemia Associated With Functional Iron Deficiency

summary:
Anemia in patients with cancer is a common problem associated with an impaired quality of life.

Treatment with erythropoiesis stimulating agents (ESA) allows an increase in hemoglobin levels in 40-70% of patients and decreased transfusion requirements.

Absolute or functional iron deficiency is also common with about 30% of cancer patients with all histologies combined iron deficiency and anemia.

Several studies have shown the benefits of the combination of intravenous iron to erythropoiesis-stimulating agents in improving hemoglobin. However, none of them, to the investigators knowledge, has not been specifically performed on a population of patients with functional iron deficiency.

In addition, in clinical practice, this association is not carried out in particular because there is no dosage or consensus sequence for the administration of iron associated with ESAs.

lead_sponsor: Centre Francois Baclesse

location_facility:
CHU
Centre François Baclesse


title: Evaluation of the Impact of Diving Training on Recovery in a Cohort of Veterans Suffering of PTSD: an Exploratory Clinical Control Trial

acronym: cognidive

summary:
Patients suffering from Chronic Posttraumatic Stress Disorder (PTSD) have difficulties in executive cognition that hinder their quality of life and make it difficult to recovery and to reintegrate them socially and professionally. These difficulties are particularly important for soldiers suffering from chronic PTSD.

The literature suggests that diving may be a complementary approach to improving cognition, in addition to its benefits on the quality of life of patients with chronic PTSD. It appears to be an intervention of interest to improve the successful recovery for veterans with PTSD compared to a multi-sport practice.

lead_sponsor: Institut de Recherche Biomedicale des Armees

location_facility:
anne-sophie Pellen
Marion

intervention_type: Behavioral


title: Monocytic Expression of HLA-DR After Liver Transplantation

acronym: EdMonHG

summary:
A defect of the immune response has been described in patients with severe liver disease. This immune-paresis is partly driven by a compensatory anti-inflammatory response following a systemic inflammatory response syndrome and affects the innate immune response. The innate immune defect has been described in patients with advanced cirrhosis and more significantly in patients with acute liver failure or acute on chronic liver failure (ACLF). The monocytes/macrophages pro-inflammatory response and finally the antimicrobial response are thus strongly impaired, leading to higher sepsis risk. The monocytes/macrophages phenotype associated with these functional alterations has been widely described, with a weaker expression of Human Leukocyte Antigen - DR isotype (HLA-DR) on the monocytes surface, correlated with poor outcomes. The low monocytic expression of HLA-DR, its functional and clinical impact has been widely described in the context of septic shock with similar pathophysiological mechanisms.

Liver transplantation (LT) is often the only therapeutic option for patients with advanced liver failure. Post-transplant survival of the most severe patients is similar to the survival in the whole population of LT patients, but the complication rate remains higher, with a major risk of infection. Currently used immunosuppression protocols do not take into account the quality of pre-transplant immune response. Some treatments, such as corticosteroids, which are widely used for the induction of post-transplant immunosuppression, may affect the innate immune response. However, it has been shown that low expression of post-transplant monocyte HLA-DR was associated with a greater risk of septic complication.

The general objective of this study is to focus on the evolution of a robust marker of immune dysfunction, HLA-DR monocyte expression, before and following LT, and to analyse its post LT expression depending on the level of pre-transplant expression as well as its association with post-transplant complications. This study will bring new insights for the design of a prospective study on the relevance of adapting post-transplant immunosuppression protocols to HLA-DR expression on monocytes surface, which is a robust marker of the innate immune response.

Evaluation of innate immune dysfunction pre-LT by quantification of monocytic HLA-DR expression and monitoring of its post-LT kinetics may be relevant for assessing post-transplant immune status and adapting immunosuppressive therapy. A descriptive, observational study associating clinical and biological data is needed to confirm the relevance of HLA-DR expression quantification on the surface of monocytes in a population of selected patients, before and after LT. These data will allow setting up a prospective interventional study reporting the possible benefit of post-transplant immunosuppressive treatment modulation, according to the HLA-DR monocyte dosage and its kinetics evolution.

The main objective of this study is to describe the association between evolution of monocytic HLA-DR expression on monocytes/macrophages surface during the first month after LT and the occurrence of one of the 2 following clinical events reflecting a post LT immune dysfunction (acute cell rejection and sepsis).

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'hépato gastroentérologie hôpital Edouard Herriot Groupement hospitalier centre

intervention_type: Biological


title: Influenza Vaccination of HCW and Hospital Acquired Influenza in Patients

summary:
Hospital acquired influenza is associated with significant morbidity and mortality in hospitalized patients notably elderly patients. Vaccination of HCW is recommended to prevent influenza transmission in healthcare setting.

Outbreaks of hospital acquired influenza were reported in stays with high vaccine coverage in patients (higher than 85%). It is necessary to underline that an adequate vaccine cover in the elderly population will not necessarily result in a total control of the incidence. Consequently, the prevention of influenza outbreaks in this vulnerable population must also include the reduction of the exposure to the influenza viruses, in particular thanks to the vaccination of HCW.

A pilote case-control study, implemented in Edouard Herriot hospital (at Lyon University hospitals), indicates that a shielding effect of more than 35% of vaccinated HCW on hospital acquired influenza among patients (Bénet et al.; BMC Infectious Diseases 2012). The results suggest a protective effect but investigations, carried out on a more important sample are needed to validate the benefit of HCW vaccination.

The aim of this prospective multicentric cohort study is to estimate incidence of influenza among hospitalized patients according to % of influenza vaccination of HCW in short stay units.

location_facility: Centre Hospitalier Universitaire - Saint Etienne

location_facility: Hospices Civils de Lyon - Hôpital Edouard Herriot


title: New Therapeutic Strategy in ALS Based on Metabolic Status and Associated Metabolic Pathways.

acronym: METABOCALS

summary: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that affects central and peripheral motor neurons. None of the clinical trials conducted have been clearly successful and the disease remains incurable, putting patients' vital prognosis at risk in the medium term. An alteration of the basal metabolism leading to hypermetabolism has been described in several articles in the literature. The causes of this hypermetabolism and the precise exploration of the metabolic pathways involved are still poorly understood. The fibroblasts of ALS patients may be the site of some metabolic disturbances in this disease with a hypothetical specific basal metabolic profile. These cells are adapted to different metabolic explorations such as omnic approaches. Superficial skin biopsy followed by fibroblast culture can provide a considerable biobank. This cellular richness will allow us, in ALS patients and their controls, to perform metabolomic and lipidomic approaches, as well as the quantification transcriptomic approach."

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Tours

location_facility: Neurology Department, University Hospitla, Tours

location_facility: Neurology Department, University Hospital, Limoges


title: Study of the Impact of Freezing-thawing Procedures and the Prolonged Culture of Embryos on Epigenetic Regulation in Humans

summary:
For this project, 4 groups of 38 infants have been created so as to evaluate the impact of Assisted-Reproduction Technology (ART) and more particularly the two procedures classically used in ART: the freezing/thawing of embryos and prolonged embryo culture (five days of culture in appropriate in vitro conditions to allow development of the embryo) in contrast with shorter culture of only two days.

Participation consists in accepting samples to be taken at the birth of the infant:

from the umbilical cord.
from the placenta.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU de BESANCON
CHU de DIJON


title: Study of Intestinal Permeability in Patients With Anorexia Nervosa

acronym: PIANO

summary:
In healthy humans, the intestinal mucosa acts as an absorption organ and a defensive barrier preventing the passage of toxic substances from the intestinal lumen to the blood stream. Malnutrition and absence of exogenous luminal nutrients in the gastrointestinal tract profoundly affect small bowel morphology and physiology. Many reports have described alterations of ion and nutrient transport, mucosal atrophy and modifications in the intestinal permeability to macromolecules in cases of prolonged intestinal rest, as in severe starvation. These changes may dampen both the absorptive and the barrier functions of intestinal mucosa.

The assessment of intestinal permeability, by measuring the urinary excretion of substances that are not metabolised by human tissues and passively cross the intestinal epithelium, is a reliable and non invasive method to investigate the anatomo-functional integrity of the intestinal mucosa. Previous studies have shown an increase of permeability in malnourished humans . The increase of may also increase the risk for inappropriate passage of food antigens and other noxious substances across the mucosal barrier. To this regard, the enhanced susceptibility of malnourished subjects to systemic infections and postoperative sepsis has long been recognised.

Anorexia nervosa is a psychiatric disorder characterised by abnormal eating behaviours aiming to decrease body weight. Typically, women with anorexia nervosa restrict food ingestion up to severe starvation. These behaviours usually lead to malnutrition and a more or less prolonged absence of luminal nutrients in the gastrointestinal tract. Therefore, alterations in the integrity and functioning of intestinal mucosa are likely to occur in this condition. There is no information on intestinal permeability in patients with eating disorders. We hypothesised that, as it occurs in simple starvation and malnutrition, intestinal permeability should be increased in fasted undernourished people with anorexia nervosa and decrease after re feeding. Therefore, in the present study, we explored intestinal permeability of 23 subjects with anorexia nervosa by means of the lactulose-mannitol test and urinary sucralose excretion and compare them to 46 controls.

Moreover, auto-antibodies (α-MSH ) have been found in patients with anorexia nervosa. The origin of these auto-antibodies is still unknown , but some studies suggested a digestive origin. Moreover, modifications of intestinal flora have been described in patients with anorexia nervosa. Actually, a study of the intestinal barrier of patients with anorexia nervosa is necessary. In this study, a comparaison of intestinal permeability and autoantibodies (α-MSH) rate is proposed before and after re-feeding in patients with anorexia nervosa.

lead_sponsor: University Hospital, Rouen

location_facility:
CHU- Hôpitaux de Rouen
Hôpital de la Croix Rouge


title: Tolerance Checkpoints Upon the B-cell Depletion Plus BAFF Blockade Strategy in Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE) (Checkpoints ITP and SLE)

acronym: ITP&SLE

summary:
The aim of this proposal is to test if anti-BAFF antibody can restore a normal threshold of tolerance in patients in two auto-immune diseases along the RITUX-PLUS study in immune thrombocytopenia, and along the Believe study in SLE. This work would help to conclude whether or not the 'double hit' therapy may help to reset the immune system toward a more tolerogenic profile.

The aim is to compare the polyreactivity and autoreactivity, of immature (central tolerance) and naïve B cells (peripheral tolerance) in the peripheral blood along the RITUX-PLUS STUDY and the BLISS BELIEVE study after treatment (B-cell reconstitution time).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Henri Mondor Hospital
Pitie Salpetriere Hospital


title: Impact of Stress Management Training on Quality of Life and Cardiac Post-transplantation Complications in a Controlled Multicentric Comparative Study.

acronym: QUIET

summary:
In spite of major medical advances in heart transplant patients, psychiatric comorbidity remains very high in pre-and post-transplant phases. Anxiety and depression are especially frequent. They impact significantly morbidity and mortality. Especially because they are associated with poor therapeutic adherence and risks of infection and rejection. The inability to make beneficial therapeutic choice can be explained by the negative perception of events, associated with anxio-depressive disorders. This results in an important deterioration in quality of life of patients.

The investigators assume that better management of emotions might reduce the stress of waiting situation and its psychopathological and somatic consequences pre-and post-transplant.

location_facility: Service de Psychiatrie d'Adultes Liaison/Consultation,


title: Feasibility of the Therapeutic Education of the Patients Diabetics Imprisoned at the Paris Jail "La Santé" (Maison d'arrêt Paris La Santé)"

acronym: EPRIDIA

summary:
A lot of data show that therapeutic education is beneficial for diabetic patients. In the French jails, there are very few programs of therapeutic education while this population is usually precarious with no access at care sector before the jail.

The purpose of this study is to determinate if the therapeutic education of the diabetic patients is possible in the Paris jail "La Santé".

location_facility:
Maison d'Arrêt Paris La Santé (MAPLS)
Hôpital COCHIN


title: Evaluation of the Effects of Eccentric Training on a Cycle Ergometer, Versus Conventional Concentric Training

acronym: ENERGETIC

summary: The aim of this study is to assess the efficacy of a rehabilitation protocol based on individualized combined eccentric and concentric cycle ergometer training compared to classical concentric cycle training among patients with either coronary artery disease (CAD) or chronic obstructive pulmonary disease (COPD). This study will therefore evaluate the efficacy of combined eccentric/concentric training on physical capacity and overall autonomy, and will analyse the adaptive mechanisms with regard to both adaptation to cardiac and muscular effort and tolerance.


title: Prediction in Silico of Overall Survival in a Pilot Prospective Cohort Study of Metastatic Breast Cancer Patients

summary:
RATIONALE : Currently, the mechanisms associated with the response or resistance to treatment are poorly understood and are multifactorial. These mechanisms involve clinical and biological factors associated with the host and the tumor and possibly the patient's psycho-social environment.

PURPOSE : This trial will assess the use of a prospective database dedicated to patients with breast cancers that contains clinical data as well as epidemiological, psychological, emotional, social, imaging, biological and bio-pathological data. These data will allow a creation of new modelling algorithms in order to predict response and resistance to treatment.

ReferenceCitation: Colombié M, Jézéquel P, Rubeaux M, Frenel JS, Bigot F, Seegers V, Campone M. The EPICURE study: a pilot prospective cohort study of heterogeneous and massive data integration in metastatic breast cancer patients. BMC Cancer. 2021 Mar 31;21(1):333. doi: 10.1186/s12885-021-08060-8.

family: Colombié

full_name: Mathilde Colombié

family: Jézéquel

full_name: Pascal Jézéquel

given: Pascal

family: Rubeaux

full_name: Mathieu Rubeaux

given: Mathieu

family: Frenel

full_name: Jean-Sébastien Frenel

given: Jean-Sébastien

family: Bigot

full_name: Frédéric Bigot

given: Frédéric

family: Seegers

full_name: Valérie Seegers

given: Valérie

family: Campone

full_name: Mario Campone

given: Mario

journal_name: BMC Cancer

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

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Institut de Cacerologie de l'ouest - site Paul Papin


title: Impact of Milk Polar Lipids Content in a Test Meal on Lipid Composition of Ileostomy Fluid and Consequences on Postprandial Dietary Cholesterol and Fatty Acid Metabolism.

acronym: VALOBAB-D

summary:
Polar lipids have a specific chemical structure: they are an essential component of human cell membranes, play a major role in the nervous system and also influence the metabolic pathways including the cholesterol metabolism.

Polar lipids are used in food-processing industry for their emulsification properties. The most famous emulsifier is soya lecithin but milk also naturally contains natural emulsifiers such as polar lipids. Milk polar lipids are rich in sphingomyelin and they may have beneficial effects on lipid metabolism in the context of metabolic diseases of nutritional origin.

The purpose of this research is to study the variation of sphingomyelin content at the ileum's end after the consumption of different doses of milk polar lipids, and consequences on the intestinal absorption and metabolism of fatty acids and cholesterol.

The subjects will be taking three different test meals varying by their milk polar lipids content.

It is a bi-centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine Rhône-Alpes) and CLERMONT-FERRAND (Centre de Recherche en Nutrition Humaine Auvergne).

ReferenceCitation: Le Barz M, Vors C, Combe E, Joumard-Cubizolles L, Lecomte M, Joffre F, Trauchessec M, Pesenti S, Loizon E, Breyton AE, Meugnier E, Bertrand K, Drai J, Robert C, Durand A, Cuerq C, Gaborit P, Leconte N, Bernalier-Donadille A, Cotte E, Laville M, Lambert-Porcheron S, Ouchchane L, Vidal H, Malpuech-Brugère C, Cheillan D, Michalski MC. Milk polar lipids favorably alter circulating and intestinal ceramide and sphingomyelin species in postmenopausal women. JCI Insight. 2021 May 24;6(10). pii: 146161. doi: 10.1172/jci.insight.146161.

family: Le Barz

full_name: Mélanie Le Barz

given: Mélanie

family: Vors

full_name: Cécile Vors

given: Cécile

family: Combe

full_name: Emmanuel Combe

given: Emmanuel

family: Joumard-Cubizolles

full_name: Laurie Joumard-Cubizolles

given: Laurie

family: Lecomte

full_name: Manon Lecomte

given: Manon

family: Joffre

full_name: Florent Joffre

given: Florent

family: Trauchessec

full_name: Michèle Trauchessec

given: Michèle

family: Pesenti

full_name: Sandra Pesenti

given: Sandra

family: Loizon

full_name: Emmanuelle Loizon

given: Emmanuelle

family: Breyton

full_name: Anne-Esther Breyton

given: Anne-Esther

family: Meugnier

full_name: Emmanuelle Meugnier

family: Bertrand

full_name: Karène Bertrand

given: Karène

family: Drai

full_name: Jocelyne Drai

given: Jocelyne

family: Robert

full_name: Chloé Robert

given: Chloé

family: Durand

full_name: Annie Durand

given: Annie

family: Cuerq

full_name: Charlotte Cuerq

given: Charlotte

family: Gaborit

full_name: Patrice Gaborit

given: Patrice

family: Leconte

full_name: Nadine Leconte

given: Nadine

family: Bernalier-Donadille

full_name: Annick Bernalier-Donadille

given: Annick

family: Cotte

full_name: Eddy Cotte

given: Eddy

family: Laville

full_name: Martine Laville

given: Martine

family: Lambert-Porcheron

full_name: Stéphanie Lambert-Porcheron

given: Stéphanie

family: Ouchchane

full_name: Lemlih Ouchchane

given: Lemlih

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

publisher: American Society for Clinical Investigation

ReferenceCitation: Vors C, Joumard-Cubizolles L, Lecomte M, Combe E, Ouchchane L, Drai J, Raynal K, Joffre F, Meiller L, Le Barz M, Gaborit P, Caille A, Sothier M, Domingues-Faria C, Blot A, Wauquier A, Blond E, Sauvinet V, Gésan-Guiziou G, Bodin JP, Moulin P, Cheillan D, Vidal H, Morio B, Cotte E, Morel-Laporte F, Laville M, Bernalier-Donadille A, Lambert-Porcheron S, Malpuech-Brugère C, Michalski MC. Milk polar lipids reduce lipid cardiovascular risk factors in overweight postmenopausal women: towards a gut sphingomyelin-cholesterol interplay. Gut. 2020 Mar;69(3):487-501. doi: 10.1136/gutjnl-2018-318155. Epub 2019 Jun 12.

location_facility: Centre de recherche en Nutrition Humaine-Auvergne -Unité d'Exploration Nutritionnelle


title: Automated Administration of Intravenous Fluids Guided by Dynamic Parameters and Cardiac Output During General Anesthesia: a Pilot Feasibility Study

acronym: Closed Loop

summary: The main objective of this study is to demonstrate that the LIR (Learning Intravenous Resuscitator) Closed-Loop Fluid Administration System (hereafter the "LIR system"), a new device for the automated administration of intravenous fluids during major abominal surgery and which allows the reinjection of 250 ml of saline filling (crystalloid or colloid), maintains blood volume at values that are acceptable by the "gold standard", i.e. the anesthetist in charge of the patient.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Montpellier - Hôpital Saint-Eloi


title: Comparison of the Urinary and Vaginal Auto-takings for the Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer.

acronym: PapU-APV

summary: Auto-takings by APU and vaginal APV during the consultations for FCU in the department of gynecology-obstetrics (Group 1) according to an instructions for use proposed to the inclusive women, with consent; the same proposal, APU and APV, is made for other consultations requiring a screening on the CHRU (Group 2: dermatology, endocrinology, ambulatory surgery, inner medicine, pneumology, oncology). Auto-takings transmitted in the laboratory of the CHRU of Brest for test HPV by quantitative real-time PCR. Results transmitted to the women and to the doctors of consultation. In case of positive test (15 %), the patients are directed to a gynecologist. Confrontation with the cytological data when available (Group 1) .

location_facility:
Hôpital Ferdinand Grall
CHRU de Brest


title: Interest of the New Technologies to Detect précocément a Respiratory Exacerbation at Patients Reached by Cystic Fibrosis.

acronym: MUSE

summary:
Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity. Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship between exacerbation frequency and QoLdeterioration. Moreover exacerbation treatments present health costs burden leading to important physical psychological and social impact. Preventing exacerbation and early detection of these exacerbations may decrease intensity and freqauency of exacerbation leading to increase clinical status and QoLwith a decreased health cost.

Patients actually follow in CRCM track exacerbations when visits out patient clinic and during phone call. If patients did not call or did not present regularly to out patient clinic, exacerbation detection came later and so increasde the burden and therapeutic pressure.

The objective of our study is to identify earlier the potential exacerbations and so decreased the health costs and increased the patient's QoL. Forthis purpose we propose to use modern technologiessuch as smartphone in order to create alert when patients report weekly health satatus. We will compra patients randomize in control group with standart follow-up to patients randomize in the smartphone group.Moreover we will study the compliance and satisfactory degree of the use of this device in the interventional arm.


title: Évaluation Des modalités Optimales de Pilotage et de l'Impact Sur Les capacités de préhension d'Une Stimulation électrique Fonctionnelle Des Muscles Extenseurs Des Doigts Chez le Patient hémiplégique en Phase Chronique

acronym: PREHENSTROKE

summary:
Stroke is the leading cause of disability in adults. The improvement of the grasp abilities remains a challenge in the 50% of post-stroke subjects who have not recovered functional grasping due to paralysis of the finger's muscles (lack of active opening of the hand).

The use of functional electrical stimulation of the prehension muscles in order to restore grasp abilities, called grasp neuroprosthesis (GP), remained confidential in post-stroke subjects while their development was important in tetraplegic subjects. GP can provide a correct hand opening with significant functional gain, but one of the major issues corresponds to the control modalities that are not adapted to the specific impairments of post-stroke subjects.

This project proposes to assess the functional contribution of an innovative autopilot closed-loop GP targeting the extensor muscles of the fingers. The main hypothesis is that the use of GP will restore grasping abilities in subjects who have lost this ability due to post-stroke paralysis.

The main objective is to assess the impact of using an autopilot closed-loop GP on the ability to perform a standardized task of grasping, moving and releasing either a glass (palmar grasp) or a spoon (key pinch), compared to the absence of GP use.

The secondary objectives of the study are: (1) to assess the impact of the GP on unimanual grasp; (2) to assess which are the preferential modes of control; (3) to assess the psycho-social impacts of GP, and (4) to assess the subject's satisfaction and tolerance to the characteristics and use of GP.

The investigators plan to include 20 post-stroke hemiplegic subjects over a period of 9 months as part of a prospective, monocentric, multi-crossover, blinded evaluation study. Subjects will have active finger extension deficit secondary to stroke, with preservation of proximal movements. Each subject will be his own control (self-pairing).

Each subject will be evaluated three times, the protocol adding approximately 1½ hours of daily assessment to routine care already received. The first visit will collect clinical data after informed consent collection. The second visit will allow to choose the optimal mode of control of the GP among 8 modalities. The third visit will test the functional gain provided by the use of GP, by comparing the success or failure of carrying out functional tasks with inactive and active GP.

location_facility:
CHU de Nîmes
CHU de TOULOUSE


title: ECG Derived Respiration for Automated Screening of Sleep Disordered Breathing in Chronic Heart Failure Patients

summary: The prevalence of sleep disordered breathing (SDB) reaches more than 50% in chronic heart failure patients (CHF). The main consequence is an increase risk of fatal and non-fatal cardiovascular events. A treatment by continuous positive airway pressure (CPAP) or adaptative servo-ventilation (ASV) reduces this risk. Nevertheless, 75% of severe SDB cases remains undiagnosed and untreated especially due to cost and time delay for polysomnography examination which is the gold standard for SDB diagnosis. Indeed, alternative methods are developed. Some methods, based on nocturnal ECG analysis showed promising results but they are not validated and adapted for cardiac population. Thus, the goal of present study is to test the accuracy of ECG derived respiration signal to screen SDB in a CHF population.

location_facility:
CHU de Grenoble
CHU de Saint-Etienne


title: The Role of Copeptin Testing During Pre-hospital Care in the Treatment of Chest Pain Suggestive of Acute Coronary Syndrome

acronym: SCA COP

summary: The main objective of our study is to evaluate the diagnostic value of copeptin testing in association with troponin HS testing during pre-hospital care (ambulance care) in the treatment of patients whose pattern of use is the occurrence chest pain suggestive of ACS but not ST+.

location_facility: CHRU de Montpellier - Hôpital Lapeyronie


title: Traditional Rehabilitation Versus Rehabilitation With the Imoove® Device for Spinal Musculoskeletal Disorders: a Randomised Controlled Trial

acronym: IMOOVE IT

summary: The main objective of this study is to evaluate in patients with chronic low back pain (lasting for more than 3 months and not postoperative) the effect of an instrumental rehabilitation using the I-Moove ® device compared to a conventional physiotherapy rehabilitation for ambulatory postural stability (mean and standard deviation of excursions from the center of gravity) without visual control, 6 weeks after the start of the rehabilitation protocol. We focus on the relative variation between the values obtained on day 0 versus 6 weeks, via measures performed on a force platform. The results will be stratified into 3 age groups (18-39 years, 40-60 years and over 60 years).


title: Immunomonitoring and Biomarker Research Based on Tumor and Blood Samples in Patients With Squamous Cell Anal Carcinoma

acronym: LAND

summary:
Even if squamous cell carcinoma of the anal canal (SCCA) is a rare disease, its incidence increases worldwide. SCCA is mostly induced by Human papillomavirus (HPV) infections and HPV-related oncoproteins (E6 and E7) are expressed in more than 90% of SCCA. T stage and N stage are recognized prognostic factors for local and/or distant recurrence in SCCA patients treated by chemoradiotherapy. In fact, ≥T3 or ≥N1 anal cancers are associated with as high as 50% of disease recurrence rate at 2 years.

The University Hospital of Besançon with the Gercor conducted a prospective clinical trial (Epitopes HPV02 study) including 69 advanced SCCA patients and established a new standard of care based on Docetaxel, Cisplatin and 5-FU (5-FluoroUracil) chemotherapy (DCF). Among 69 patients treated with DCF regimen, 66 patients were evaluable for efficacy end-points. The objective response rate was 86% including 44% of complete response, and 47% of patients were progression-free at 12 months of follow-up from the first cycle of DCF treatment. Thus, the "Epitopes-HPV02" trial has demonstrated a high response rate of the DCF regimen with a higher than expected 12 months progression-free survival rate.These results raised the hypothesis of DCF being an immunogenic chemotherapy and in that demonstrating a possibly new role of taxane-based chemotherapy in SCCA patients. More than 50% of patients in complete remission had a detectable immunological response against peptides derived from HPV oncoproteins (E6 or E7) or from the telomerase antigen (which is transactivated by E6).

LAND study will enroll patients with locally advanced SCCA enrolled in OPTIMANAL clinical trial. OPTIMANAL study will assess the feasibility and efficacy to combine nivolumab to mDCF chemotherapy, followed by the standard chemo-radiotherapy, in high risk locally advanced SCCA patients with T3/T4 N1a or N1b/N1c disease.

LAND study is an exploratory translational study, which will analyze the biological mechanisms of action and our ability to track the immune responses against HPV and telomerase. The investigator group will take advantage of the presence of HPV antigens in most patients to set up a specific immunomonitoring program based on tumor samples and blood-derived lymphocytes to better understand the potential synergisms between immunogenic chemotherapy and anti-PD1 (Programmed Death-1), and to identify valuable biomarkers of treatment efficacy.

status: Withdrawn

ReferenceCitation: Kim S, Jary M, André T, Vendrely V, Buecher B, François E, Bidard FC, Dumont S, Samalin E, Peiffert D, Pernot S, Baba-Hamed N, El Hajbi F, Bouché O, Desrame J, Parzy A, Zoubir M, Louvet C, Bachet JB, Nguyen T, Abdelghani MB, Smith D, De La Fouchardière C, Aparicio T, Bennouna J, Gornet JM, Jacquin M, Bonnetain F, Borg C. Docetaxel, Cisplatin, and 5-fluorouracil (DCF) chemotherapy in the treatment of metastatic or unresectable locally recurrent anal squamous cell carcinoma: a phase II study of French interdisciplinary GERCOR and FFCD groups (Epitopes-HPV02 study). BMC Cancer. 2017 Aug 25;17(1):574. doi: 10.1186/s12885-017-3566-0.

family: Kim

full_name: Stefano Kim

given: Stefano

family: Jary

full_name: Marine Jary

given: Marine

family: André

full_name: Thierry André

given: Thierry

family: Vendrely

full_name: Véronique Vendrely

given: Véronique

family: Buecher

full_name: Bruno Buecher

given: Bruno

family: François

full_name: Eric François

given: Eric

family: Bidard

full_name: François-Clément Bidard

given: François-Clément

family: Dumont

full_name: Sarah Dumont

given: Sarah

family: Samalin

full_name: Emmanuelle Samalin

family: Peiffert

full_name: Didier Peiffert

given: Didier

family: Pernot

full_name: Simon Pernot

given: Simon

family: Baba-Hamed

full_name: Nabil Baba-Hamed

given: Nabil

family: El Hajbi

full_name: Farid El Hajbi

given: Farid

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Desrame

full_name: Jérôme Desrame

given: Jérôme

family: Parzy

full_name: Aurélie Parzy

given: Aurélie

family: Zoubir

full_name: Mustapha Zoubir

given: Mustapha

family: Louvet

full_name: Christophe Louvet

given: Christophe

family: Bachet

full_name: Jean-Baptiste Bachet

given: Jean-Baptiste

family: Nguyen

full_name: Thierry Nguyen

family: Abdelghani

full_name: Meher Ben Abdelghani

given: Meher Ben

family: Smith

full_name: Denis Smith

given: Denis

family: De La Fouchardière

full_name: Christelle De La Fouchardière

given: Christelle

ReferenceCitation: Bernard-Tessier A, Jeannot E, Guenat D, Debernardi A, Michel M, Proudhon C, Vincent-Salomon A, Bièche I, Pierga JY, Buecher B, Meurisse A, François É, Cohen R, Jary M, Vendrely V, Samalin E, El Hajbi F, Baba-Hamed N, Borg C, Bidard FC, Kim S. Clinical Validity of HPV Circulating Tumor DNA in Advanced Anal Carcinoma: An Ancillary Study to the Epitopes-HPV02 Trial. Clin Cancer Res. 2019 Apr 1;25(7):2109-2115. doi: 10.1158/1078-0432.CCR-18-2984. Epub 2018 Nov 30.

ReferenceCitation: Kim S, François E, André T, Samalin E, Jary M, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouché O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, De La Fouchardiere C, Smith D, Deberne M, Spehner L, Badet N, Adotevi O, Anota A, Meurisse A, Vernerey D, Taieb J, Vendrely V, Buecher B, Borg C. Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2018 Aug;19(8):1094-1106. doi: 10.1016/S1470-2045(18)30321-8. Epub 2018 Jul 2.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Effets de la tDCS Sur la Performance Sportive de 2 Profils d'athlètes : Explosifs (Sauteurs de Haut Niveau et Amateur) et Endurants (Cyclistes de Haut Niveau et Amateur)

acronym: COMPETE

summary: The study aims to compare the effects of tDCS applied on the dorsolateral prefrontal cortex (dlPFC) vs sham on the neuromuscular system. Two types of athletes will benefit from stimulation: jumper and cyclists. Short and long term effects are assesed by electromyographic records, experimental tasks and self-rated scales.

ReferenceCitation: Grandperrin Y, Grosprêtre S, Nicolier M, Gimenez P, Vidal C, Haffen E, Bennabi D. Effect of transcranial direct current stimulation on sports performance for two profiles of athletes (power and endurance) (COMPETE): a protocol for a randomised, crossover, double blind, controlled exploratory trial. Trials. 2020 Jun 3;21(1):461. doi: 10.1186/s13063-020-04412-0.

family: Grandperrin

full_name: Yohan Grandperrin

given: Yohan

family: Grosprêtre

full_name: Sidney Grosprêtre

given: Sidney

family: Nicolier

full_name: Magali Nicolier

given: Magali

family: Gimenez

full_name: Philippe Gimenez

given: Philippe

family: Vidal

full_name: Chrystelle Vidal

given: Chrystelle

family: Haffen

full_name: Emmanuel Haffen

given: Emmanuel

family: Bennabi

full_name: Djamila Bennabi

given: Djamila

location_facility: CHU Besancon - Clinical Psychiatric Department

location_facility: EA4660- C3S, Culture, Sport, Santé, Société


title: Does the Subject's Understanding of Underlying Placebo Mechanisms Compensate for the Loss of Efficacy Associated With the Disclosure of the Use of a Placebo

acronym: PLACETHIC

summary:
The investigators are investigating whether, when given detailed information about underlying placebo mechanisms and pain, subjects will have a response similar to that of those subjected to a procedure in which they receive a conventional placebo treatment (associated with deception).

STUDY DESIGN: This is a non-inferior parallel, controlled and randomized, single blind trial.

POPULATION: The investigators will include in the study 126 subjects without known pathology. Participants will then be divided into 2 groups on a randomized basis.

METHODOLOGY: Each subject will undergo three sessions of Cold Pressure Test (CPT), a cold pain stimulation method: calibration, condition of interest (conventional placebo or educated placebo) and control. The investigators' main judgment criterion is be the difference in pain intensity experienced on the visual analog scale between the CPT control and the CPT under the condition of interest.

This study will allow the investigators to rule on the non-inferiority of an educated open label placebo compared to a conventional placebo in the context of an acute painful stimulation.

ReferenceCitation: Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010 Dec 22;5(12):e15591. doi: 10.1371/journal.pone.0015591.

ReferenceCitation: Locher C, Frey Nascimento A, Kirsch I, Kossowsky J, Meyer A, Gaab J. Is the rationale more important than deception? A randomized controlled trial of open-label placebo analgesia. Pain. 2017 Dec;158(12):2320-2328. doi: 10.1097/j.pain.0000000000001012.

ReferenceCitation: Benedetti F, Carlino E, Pollo A. How placebos change the patient's brain. Neuropsychopharmacology. 2011 Jan;36(1):339-54. doi: 10.1038/npp.2010.81. Epub 2010 Jun 30. Review.

ReferenceCitation: Benedetti F, Amanzio M. Mechanisms of the placebo response. Pulm Pharmacol Ther. 2013 Oct;26(5):520-3. doi: 10.1016/j.pupt.2013.01.006. Epub 2013 Jan 28. Review.

ReferenceCitation: Colloca L, Howick J. Placebos Without Deception: Outcomes, Mechanisms, and Ethics. Int Rev Neurobiol. 2018;138:219-240. doi: 10.1016/bs.irn.2018.01.005. Epub 2018 Apr 4. Review.

ReferenceCitation: Voudouris NJ, Peck CL, Coleman G. The role of conditioning and verbal expectancy in the placebo response. Pain. 1990 Oct;43(1):121-128. doi: 10.1016/0304-3959(90)90057-K.

ReferenceCitation: Pecina M, Zubieta JK. Expectancy Modulation of Opioid Neurotransmission. Int Rev Neurobiol. 2018;138:17-37. doi: 10.1016/bs.irn.2018.02.003. Epub 2018 Apr 2. Review.

ReferenceCitation: Mitchell LA, MacDonald RA, Brodie EE. Temperature and the cold pressor test. J Pain. 2004 May;5(4):233-7.

ReferenceCitation: Streff A, Kuehl LK, Michaux G, Anton F. Differential physiological effects during tonic painful hand immersion tests using hot and ice water. Eur J Pain. 2010 Mar;14(3):266-72. doi: 10.1016/j.ejpain.2009.05.011. Epub 2009 Jun 21.

ReferenceCitation: Carvalho C, Caetano JM, Cunha L, Rebouta P, Kaptchuk TJ, Kirsch I. Open-label placebo treatment in chronic low back pain: a randomized controlled trial. Pain. 2016 Dec;157(12):2766-2772. doi: 10.1097/j.pain.0000000000000700. Erratum in: Pain. 2017 Feb;158(2):365.

ReferenceCitation: Druart L, Graham Longsworth S, Rolland C, Dolgopoloff M, Terrisse H, Bosson JL, Pinsault N. Can an Open-Label Placebo Be as Effective as a Deceptive Placebo? Methodological Considerations of a Study Protocol. Medicines (Basel). 2020 Jan 2;7(1). pii: E3. doi: 10.3390/medicines7010003.

family: Druart

full_name: Leo Druart

given: Leo

family: Graham Longsworth

full_name: SaraEve Graham Longsworth

given: SaraEve

family: Rolland

full_name: Carole Rolland

given: Carole

family: Dolgopoloff

full_name: Maïa Dolgopoloff

given: Maïa

family: Terrisse

full_name: Hugo Terrisse

given: Hugo

family: Bosson

full_name: Jean-Luc Bosson

given: Jean-Luc

family: Pinsault

full_name: Nicolas Pinsault

given: Nicolas

currency_apc_doaj: CHF

journal_name: Medicines

publisher: MDPI AG

publisher_dissemination: MDPI

publisher_group: MDPI

publisher_normalized: MDPI

lead_sponsor: Laboratoire TIMC-IMAG

location_facility:
Saraeve Graham Longsworth
Leo Druart