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

acronym: PDT-Bactério

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


type: Other Grant/Funding Number

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

acronym: NEUROSWITCH

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

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

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

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Actual

lead_sponsor: University Hospital, Toulouse

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Impact of a Feedback Device, CPRmeter®, on Chest Compression Quality During Extend Cardio-pulmonary Resuscitation. A Manikin Study.

acronym: CILICA-FS

summary:
Context: Chest compressions represent an important physical effort leading to fatigue and cardiopulmonary resuscitation quality degradation. Despite a known harmful effect of chest compressions interruptions, current guidelines still recommend provider switch every 2 minutes. Feedback impact on chest compressions quality during an extended cardiopulmonary resuscitation remains to be assessed.

Study design: simulated prospective monocentric randomized crossover trial. Participants and methods: Sixty professionals rescuers of the pre-hospital care unit of University Hospital of Caen (doctors, nurses and ambulance drivers) are enrolled to performed 10 minutes of continuous chest compression on manikin (ResusciAnne®, Laerdal), twice, with and without a feedback device (CPRmeter®). Correct compression score (the main criterion) is defined by reached target of rate, depth and leaning at the same time (recorded continuously).

Hypothesis: Feedback device delay fatigue effect arises during cardiopulmonary resuscitation.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Caen


title: A Randomized Controlled Trial on the Effect of Needle Gauge on the Pain and Anxiety Experienced During Arterial Puncture

summary:
Arterial blood-gas (ABG) measurements are the gold standard to evaluate pulmonary gas exchange. However, arterial punctures are more painful than venous punctures and, in ICU patients, cause greater anxiety than tracheal aspiration. The only technique that has been shown to effectively reduce pain during arterial punctures is the subcutaneous injection of lidocaine. However, this technique is more time consuming and is poorly used.

Topical anesthesia is widely used during arterial punctures despite the lack of proof of efficacy.

While performing arterial punctures with small gauge needles is feasible, to the best of the investigators knowledge no studies have assessed the effect of needle gauge on arterial puncture related pain.

The aim of the present study was to compare the pain experienced during arterial punctures performed with a 25 G or 23 G needle. The secondary endpoints were the characterization of the pain and the anxiety associated with the arterial punctures.

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Patout M, Lamia B, Lhuillier E, Molano LC, Viacroze C, Benhamou D, Muir JF, Cuvelier A. A Randomized Controlled Trial on the Effect of Needle Gauge on the Pain and Anxiety Experienced during Radial Arterial Puncture. PLoS One. 2015 Sep 25;10(9):e0139432. doi: 10.1371/journal.pone.0139432. eCollection 2015.

family: Patout

full_name: Maxime Patout

given: Maxime

sequence: first

family: Lamia

full_name: Bouchra Lamia

given: Bouchra

sequence: additional

family: Lhuillier

full_name: Elodie Lhuillier

given: Elodie

family: Molano

full_name: Luis-Carlos Molano

given: Luis-Carlos

family: Viacroze

full_name: Catherine Viacroze

given: Catherine

family: Benhamou

full_name: Daniel Benhamou

given: Daniel

family: Muir

full_name: Jean-François Muir

given: Jean-François

family: Cuvelier

full_name: Antoine Cuvelier

given: Antoine

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: PLOS ONE

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

lead_sponsor: University Hospital, Rouen

intervention_type: Procedure


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

name: CeRéMAIA AP‐HP Bicêtre Hospital University of Paris Sud Saclay  Paris France

family: Koné‐Paut

full_name: Isabelle Koné‐Paut

given: Isabelle

family: Tellier

full_name: Stéphanie Tellier

given: Stéphanie

name: University of Lyon International Center for Research in Infectious Diseases INSERM U1111 ENS  Lyon France

family: Belot

full_name: Alexandre Belot

given: Alexandre

family: Brochard

full_name: Karine Brochard

given: Karine

family: Guitton

full_name: Corinne Guitton

given: Corinne

family: Marie

full_name: Isabelle Marie

name: Robert Debre University Hospital  Paris France

family: Meinzer

full_name: Ulrich Meinzer

given: Ulrich

name: CeRéMAIA Bicêtre Hospital AP‐HP University of Paris Sud Saclay INSERM U1173  Paris France

family: Cherqaoui

full_name: Bilade Cherqaoui

given: Bilade

family: Galeotti

full_name: Caroline Galeotti

given: Caroline

name: AP‐HP University of Paris Saclay Bicêtre Hospital  Paris France

family: Boukhedouni

full_name: Nadja Boukhedouni

given: Nadja

family: Agostini

full_name: Helene Agostini

given: Helene

name: Cedars‐Sinai Medical Center  Los Angeles California

family: Arditi

full_name: Moshe Arditi

given: Moshe

name: Institut Mutualiste Montsouris and Bicêtre Hospital AP‐HP University of Paris Sud Saclay  Paris France

family: Lambert

full_name: Virginie Lambert

given: Virginie

family: Piedvache

full_name: Céline Piedvache

given: Céline

journal_name: Arthritis & Rheumatology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Phase II Open Label Study of Anakinra in Intravenous Immunoglobulin–Resistant Kawasaki Disease

intervention_type: Drug

study_start_date_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

primary_purpose: Treatment

acronym: KAWAKINRA

type: EudraCT Number

source: euctr

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

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


type: Other Identifier

title: Effect of Eccentric Exercise Training in Rheumatoid Cachexia

acronym: EECRA

summary: The purpose of the study is to determine in a randomized controlled trial (RCT), the efficacy of eccentric exercise training in restoring muscle mass and function in patients with rheumatoid cachexia.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Other

status_simplified: Unknown


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

acronym: Coli-NASH

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

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

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

family: Smati

full_name: Sarra Smati

given: Sarra

family: Polizzi

full_name: Arnaud Polizzi

given: Arnaud

family: Fougerat

full_name: Anne Fougerat

given: Anne

family: Ellero-Simatos

full_name: Sandrine Ellero-Simatos

given: Sandrine

family: Blum

full_name: Yuna Blum

given: Yuna

family: Lippi

full_name: Yannick Lippi

given: Yannick

family: Régnier

full_name: Marion Régnier

given: Marion

family: Laroyenne

full_name: Alexia Laroyenne

given: Alexia

family: Huillet

full_name: Marine Huillet

given: Marine

family: Arif

full_name: Muhammad Arif

given: Muhammad

family: Zhang

full_name: Cheng Zhang

given: Cheng

family: Lasserre

full_name: Frederic Lasserre

given: Frederic

family: Marrot

full_name: Alain Marrot

given: Alain

family: Al Saati

full_name: Talal Al Saati

given: Talal

family: Wan

full_name: JingHong Wan

given: JingHong

family: Sommer

full_name: Caroline Sommer

family: Naylies

full_name: Claire Naylies

given: Claire

family: Batut

full_name: Aurelie Batut

given: Aurelie

family: Lukowicz

full_name: Celine Lukowicz

given: Celine

family: Fougeray

full_name: Tiffany Fougeray

given: Tiffany

family: Tramunt

full_name: Blandine Tramunt

given: Blandine

family: Dubot

full_name: Patricia Dubot

given: Patricia

family: Smith

full_name: Lorraine Smith

given: Lorraine


title: Development of a Multimodal Controlled Device for Improvement and Monitoring of Freezing in Parkinsonian Patients

acronym: demarpark

summary: Freezing of gait (FOG) is a particular and troublesome symptom occurring in some Parkinsonian patients. Our objective is to adapt and extend FOG detectors in order to include other associated gait pattern changes, like festination.Our purpose is to develop a wearable assistant which would trigger the most appropriate cueing aid just before occurrence of the freezing episode.

lead_sponsor: University Hospital, Montpellier


title: Physical Exercise Prescription With PEdometeR in General Practice for Patients With Cardiovascular Risk Factors - The PEPPER Pragmatic Randomised Controlled Trial

acronym: PEPPER

summary: This study evaluates the efficacy, in terms of energy expenditure, physical activity level, quality of life, blood pressure, waist circumference and weight, of a general practice based intervention involving a personalised physical exercise medical prescription, the structured delivery of information on the benefits of physical activity, a pedometer, and a pedometer log book, in 35 to 74 year old patients with cardiovascular risks factors.

ReferenceCitation: Missud DC, Parot-Schinkel E, Connan L, Vielle B, Huez JF. Physical activity prescription for general practice patients with cardiovascular risk factors-the PEPPER randomised controlled trial protocol. BMC Public Health. 2019 Jun 3;19(1):688. doi: 10.1186/s12889-019-7048-y.

family: Missud

full_name: David C. Missud

given: David C.

family: Parot-Schinkel

full_name: Elsa Parot-Schinkel

given: Elsa

family: Connan

full_name: Laurent Connan

given: Laurent

family: Vielle

full_name: Bruno Vielle

given: Bruno

family: Huez

full_name: Jean-François Huez

given: Jean-François

currency_apc_doaj: GBP

journal_name: BMC Public Health

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Physical activity prescription for general practice patients with cardiovascular risk factors–the PEPPER randomised controlled trial protocol

lead_sponsor: University Hospital, Angers

intervention_type: Behavioral


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

acronym: PACTE-q

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

time_perspective: Cross-Sectional


title: Mobility Assessment & Follow-up in Frail Elderly: Clinic-technical Validation of a Smart Insole in Real Life

acronym: RESPECT

summary: The investigators aim is to evaluate an instrument for supporting physical activity and monitors multiple parameters of frailty (a pre-disability condition) in frail elderly persons. The investigators are therefore developing a smart shoe insole to monitor key parameters of frailty during subject daily life and to promote walking. Our primary aim is to assess the acceptability of the solution for the follow up and the motivational coaching of frail patients at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficacy of the solution to prevent disability.

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Abellan van Kan G, Rolland Y, Bergman H, Morley JE, Kritchevsky SB, Vellas B. The I.A.N.A Task Force on frailty assessment of older people in clinical practice. J Nutr Health Aging. 2008 Jan;12(1):29-37. Review.

ReferenceCitation: Ahmed N, Mandel R, Fain MJ. Frailty: an emerging geriatric syndrome. Am J Med. 2007 Sep;120(9):748-53.

ReferenceCitation: Barlow J, Singh D, Bayer S, Curry R. A systematic review of the benefits of home telecare for frail elderly people and those with long-term conditions. J Telemed Telecare. 2007;13(4):172-9. Review.

ReferenceCitation: Binder EF, Schechtman KB, Ehsani AA, Steger-May K, Brown M, Sinacore DR, Yarasheski KE, Holloszy JO. Effects of exercise training on frailty in community-dwelling older adults: results of a randomized, controlled trial. J Am Geriatr Soc. 2002 Dec;50(12):1921-8.

ReferenceCitation: Boyd CM, Xue QL, Simpson CF, Guralnik JM, Fried LP. Frailty, hospitalization, and progression of disability in a cohort of disabled older women. Am J Med. 2005 Nov;118(11):1225-31.

ReferenceCitation: Brown M, Sinacore DR, Ehsani AA, Binder EF, Holloszy JO, Kohrt WM. Low-intensity exercise as a modifier of physical frailty in older adults. Arch Phys Med Rehabil. 2000 Jul;81(7):960-5.

ReferenceCitation: Cesari M, Kritchevsky SB, Penninx BW, Nicklas BJ, Simonsick EM, Newman AB, Tylavsky FA, Brach JS, Satterfield S, Bauer DC, Visser M, Rubin SM, Harris TB, Pahor M. Prognostic value of usual gait speed in well-functioning older people--results from the Health, Aging and Body Composition Study. J Am Geriatr Soc. 2005 Oct;53(10):1675-80.

ReferenceCitation: Cesari M, Onder G, Russo A, Zamboni V, Barillaro C, Ferrucci L, Pahor M, Bernabei R, Landi F. Comorbidity and physical function: results from the aging and longevity study in the Sirente geographic area (ilSIRENTE study). Gerontology. 2006;52(1):24-32.

ReferenceCitation: Cesari M, Kritchevsky SB, Newman AB, Simonsick EM, Harris TB, Penninx BW, Brach JS, Tylavsky FA, Satterfield S, Bauer DC, Rubin SM, Visser M, Pahor M; Health, Aging and Body Composition Study. Added value of physical performance measures in predicting adverse health-related events: results from the Health, Aging And Body Composition Study. J Am Geriatr Soc. 2009 Feb;57(2):251-9. doi: 10.1111/j.1532-5415.2008.02126.x.

ReferenceCitation: Chan M, Campo E, Estève D, Fourniols JY. Smart homes - current features and future perspectives. Maturitas. 2009 Oct 20;64(2):90-7. doi: 10.1016/j.maturitas.2009.07.014. Epub 2009 Sep 2. Review.

ReferenceCitation: Daniels R, van Rossum E, de Witte L, Kempen GI, van den Heuvel W. Interventions to prevent disability in frail community-dwelling elderly: a systematic review. BMC Health Serv Res. 2008 Dec 30;8:278. doi: 10.1186/1472-6963-8-278. Review.

ReferenceCitation: Dolansky MA, Moore SM. Effects of cardiac rehabilitation on the recovery outcomes of older adults after coronary artery bypass surgery. J Cardiopulm Rehabil. 2004 Jul-Aug;24(4):236-44.

ReferenceCitation: Ensrud KE, Ewing SK, Taylor BC, Fink HA, Stone KL, Cauley JA, Tracy JK, Hochberg MC, Rodondi N, Cawthon PM; Study of Osteoporotic Fractures Research Group. Frailty and risk of falls, fracture, and mortality in older women: the study of osteoporotic fractures. J Gerontol A Biol Sci Med Sci. 2007 Jul;62(7):744-51.

ReferenceCitation: Ettinger WH Jr, Burns R, Messier SP, Applegate W, Rejeski WJ, Morgan T, Shumaker S, Berry MJ, O'Toole M, Monu J, Craven T. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The Fitness Arthritis and Seniors Trial (FAST). JAMA. 1997 Jan 1;277(1):25-31.

ReferenceCitation: Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56.

ReferenceCitation: Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. Review.

ReferenceCitation: Gill TM, Gahbauer EA, Allore HG, Han L. Transitions between frailty states among community-living older persons. Arch Intern Med. 2006 Feb 27;166(4):418-23.

ReferenceCitation: Gitlin LN, Hauck WW, Dennis MP, Winter L, Hodgson N, Schinfeld S. Long-term effect on mortality of a home intervention that reduces functional difficulties in older adults: results from a randomized trial. J Am Geriatr Soc. 2009 Mar;57(3):476-81. doi: 10.1111/j.1532-5415.2008.02147.x. Epub 2009 Jan 23.

ReferenceCitation: LIFE Study Investigators, Pahor M, Blair SN, Espeland M, Fielding R, Gill TM, Guralnik JM, Hadley EC, King AC, Kritchevsky SB, Maraldi C, Miller ME, Newman AB, Rejeski WJ, Romashkan S, Studenski S. Effects of a physical activity intervention on measures of physical performance: Results of the lifestyle interventions and independence for Elders Pilot (LIFE-P) study. J Gerontol A Biol Sci Med Sci. 2006 Nov;61(11):1157-65. Erratum in: J Gerontol A Biol Sci Med Sci. 2007 Mar;62(3):337.

ReferenceCitation: Marshall SJ, Levy SS, Tudor-Locke CE, Kolkhorst FW, Wooten KM, Ji M, Macera CA, Ainsworth BE. Translating physical activity recommendations into a pedometer-based step goal: 3000 steps in 30 minutes. Am J Prev Med. 2009 May;36(5):410-5. doi: 10.1016/j.amepre.2009.01.021.

ReferenceCitation: Montero-Odasso M, Schapira M, Soriano ER, Varela M, Kaplan R, Camera LA, Mayorga LM. Gait velocity as a single predictor of adverse events in healthy seniors aged 75 years and older. J Gerontol A Biol Sci Med Sci. 2005 Oct;60(10):1304-9.

ReferenceCitation: Nelson ME, Layne JE, Bernstein MJ, Nuernberger A, Castaneda C, Kaliton D, Hausdorff J, Judge JO, Buchner DM, Roubenoff R, Fiatarone Singh MA. The effects of multidimensional home-based exercise on functional performance in elderly people. J Gerontol A Biol Sci Med Sci. 2004 Feb;59(2):154-60.

ReferenceCitation: Ní Scanaill C, Carew S, Barralon P, Noury N, Lyons D, Lyons GM. A review of approaches to mobility telemonitoring of the elderly in their living environment. Ann Biomed Eng. 2006 Apr;34(4):547-63. Epub 2006 Mar 21. Review.

ReferenceCitation: Penninx BW, Messier SP, Rejeski WJ, Williamson JD, DiBari M, Cavazzini C, Applegate WB, Pahor M. Physical exercise and the prevention of disability in activities of daily living in older persons with osteoarthritis. Arch Intern Med. 2001 Oct 22;161(19):2309-16.

ReferenceCitation: Sabatini AM, Martelloni C, Scapellato S, Cavallo F. Assessment of walking features from foot inertial sensing. IEEE Trans Biomed Eng. 2005 Mar;52(3):486-94.

ReferenceCitation: Santos-Eggimann B, Cuénoud P, Spagnoli J, Junod J. Prevalence of frailty in middle-aged and older community-dwelling Europeans living in 10 countries. J Gerontol A Biol Sci Med Sci. 2009 Jun;64(6):675-81. doi: 10.1093/gerona/glp012. Epub 2009 Mar 10.

ReferenceCitation: Savolainen L, Hanson E, Magnusson L, Gustavsson T. An Internet-based videoconferencing system for supporting frail elderly people and their carers. J Telemed Telecare. 2008;14(2):79-82. doi: 10.1258/jtt.2007.070601.

ReferenceCitation: Tien I, Glaser SD, Bajcsy R, Goodin DS, Aminoff MJ. Results of using a wireless inertial measuring system to quantify gait motions in control subjects. IEEE Trans Inf Technol Biomed. 2010 Jul;14(4):904-15. doi: 10.1109/TITB.2009.2021650. Epub 2009 May 5.

ReferenceCitation: Wu G, Keyes LM. Group tele-exercise for improving balance in elders. Telemed J E Health. 2006 Oct;12(5):561-70.

ReferenceCitation: Piau A, Charlon Y, Campo E, Vellas B, Nourhashemi F. A Smart Insole to Promote Healthy Aging for Frail Elderly Individuals: Specifications, Design, and Preliminary Results. JMIR Rehabil Assist Technol. 2015 May 25;2(1):e5. doi: 10.2196/rehab.4084.

apc_source: doaj

family: Piau

full_name: Antoine Piau

given: Antoine

family: Charlon

full_name: Yoann Charlon

given: Yoann

family: Campo

full_name: Eric Campo

given: Eric

family: Vellas

full_name: Bruno Vellas

family: Nourhashemi

full_name: Fati Nourhashemi

given: Fati

journal_name: JMIR Rehabilitation and Assistive Technologies

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

repository_normalized: HAL

repositories:
HAL
PubMed Central

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications


title: Long-term Additive Prognostic Value of Heterogeneity Myocardial Perfusion Imaging of SPECT Over Clinical and Ischemia in High-risk Diabetic Patients.

acronym: EVADIAB

summary: Long-term additive prognostic value of heterogeneity myocardial perfusion imaging of SPECT over clinical and ischemia in high-risk diabetic patients

ReferenceCitation: Djaileb L, Seiller A, Canu M, De Leiris N, Martin A, Poujol J, Fraguas-Rubio A, Leenhardt J, Carabelli A, Calizzano A, De Fondaumière M, Broisat A, Desvignes M, Vanzetto G, Ghezzi C, Fagret D, Riou LM, Barone-Rochette G. Prognostic value of SPECT myocardial perfusion entropy in high-risk type 2 diabetic patients. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1813-1821. doi: 10.1007/s00259-020-05110-4. Epub 2020 Nov 20.

family: Djaileb

full_name: Loïc Djaileb

given: Loïc

family: Seiller

full_name: Alexandre Seiller

given: Alexandre

family: Canu

full_name: Marjorie Canu

given: Marjorie

family: De Leiris

full_name: Nicolas De Leiris

given: Nicolas

family: Martin

full_name: Alix Martin

given: Alix

family: Poujol

full_name: Julie Poujol

given: Julie

family: Fraguas-Rubio

full_name: Alicia Fraguas-Rubio

given: Alicia

family: Leenhardt

full_name: Julien Leenhardt

given: Julien

family: Carabelli

full_name: Adrien Carabelli

given: Adrien

family: Calizzano

full_name: Alex Calizzano

given: Alex

family: De Fondaumière

full_name: Marie De Fondaumière

given: Marie

family: Broisat

full_name: Alexis Broisat

given: Alexis

family: Desvignes

full_name: Michel Desvignes

given: Michel

family: Vanzetto

full_name: Gérald Vanzetto

given: Gérald

family: Ghezzi

full_name: Catherine Ghezzi

given: Catherine

family: Fagret

full_name: Daniel Fagret

given: Daniel

family: Riou

full_name: Laurent M. Riou

given: Laurent M.

family: Barone-Rochette

full_name: Gilles Barone-Rochette

given: Gilles

journal_name: European Journal of Nuclear Medicine and Molecular Imaging

lead_sponsor: University Hospital, Grenoble


title: Phase III Trial Evaluating Maintenance Treatment Versus Observation in Elderly Patients Suffering From Primary Central Nervous System Lymphoma in Complete Remission After High Dose Methotrexate Based Chemotherapy in First Line

summary:
Hypothesis

Our hypothesis is that maintenance chemotherapy will prolong complete remission obtained after a standard induction chemotherapy with an acceptable toxicity in the elderly.

Rationale

Treatment of the elderly is challenging, indeed age over 60 is associated both with a poor prognosis and a high risk of treatment induced neurotoxicity with devastating consequences on quality of life. Therefore it has become standard practice to treat elderly in first line with high-dose methotrexate (MTX) based polychemotherapy alone, avoiding whole brain radiotherapy (WBRT) or deferring it for recurrence.
There is a clear need to improve disease control after induction chemotherapy. Since consolidation with WBRT or intensive chemotherapy with autologous stem cell rescue are either poorly effective and/or too toxic in the elderly population, maintenance chemotherapy is an interesting alternative approach. Several agents, such as high-dose MTX, temozolomide (TMZ), rituximab, with a reported activity in PCNSL and acceptable safety profile, as single agent or combined, are good candidates for maintenance

status: Recruiting

ipd_sharing: No

status_simplified: Ongoing


title: Non-inferiority Trial of Intradiscal Discogel® Versus Surgery in Sciatica Resistant to Conservative Treatment

acronym: EDIS

summary:
Sciatica due to herniated disc is a major cause of disability in young adults. Surgery is the gold-standard and the only controlled treatment in case of failure of conservative treatment.

Percutaneous chemonucleolysis with Discogel® may be a valuable alternative to surgery.

In addition, Discogel® chemonucleolysis appears as a relatively innocuous technique which may avoid 2% complications after disc surgery and 5% repeated surgery (according to recent trials).

This will be the first randomized trial comparing Discogel® chemonucleolysis versus surgery in patients with sciatica due to lumbar disc herniation and unresponsive to conservative medical treatments (including epidural steroid injections) Our expectation is that Discogel® chemonucleolysis will avoid surgery in 80% of the patients.

study_start_date_type: Anticipated

status: Withdrawn

location_facility: Department of Rheumatology, Lariboisière Hospital


title: Essai de faisabilité Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d&Apos;ExérèsE

acronym: PERSEE

summary:
This study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy (nCLE).

Contraindications for resection surgery may sometimes be missed during exploratory surgical procedures. That may lead to an incomplete thus useless surgery and delay the right treatment.

The objectives of this study are to improve the detection of cancer extension during exploratory procedures and to guide resection to ensure clear margins.

ReferenceCitation: Fuks D, Pierangelo A, Validire P, Lefevre M, Benali A, Trebuchet G, Criton A, Gayet B. Intraoperative confocal laser endomicroscopy for real-time in vivo tissue characterization during surgical procedures. Surg Endosc. 2019 May;33(5):1544-1552. doi: 10.1007/s00464-018-6442-3. Epub 2018 Sep 19.

family: Fuks

full_name: David Fuks

given: David

family: Pierangelo

full_name: Angelo Pierangelo

given: Angelo

family: Validire

full_name: Pierre Validire

given: Pierre

family: Lefevre

full_name: Marine Lefevre

given: Marine

family: Benali

full_name: Abdelali Benali

given: Abdelali

family: Trebuchet

full_name: Guillaume Trebuchet

given: Guillaume

family: Criton

full_name: Aline Criton

given: Aline

family: Gayet

full_name: Brice Gayet

given: Brice

journal_name: Surgical Endoscopy

lead_sponsor: Institut Mutualiste Montsouris

lead_sponsor_type: industriel


title: Determination of the Mechanisms Involved in Conduit Artery Endothelial Dysfunction in Type 2 Diabetes

acronym: DIAB-EETs

summary: Endothelial dysfunction of conduit arteries plays an important role in the development of cardiovascular complications associated with type 2 diabetes. In order to propose targeted therapeutic approaches, this study aim to determine the mechanisms involved in endothelial dysfunction of conduit arteries in these patients.

primary_purpose: Other

ReferenceCitation: Duflot T, Moreau-Grangé L, Roche C, Iacob M, Wils J, Rémy-Jouet I, Cailleux AF, Leuillier M, Renet S, Li D, Morisseau C, Lamoureux F, Richard V, Prévost G, Joannidès R, Bellien J. Altered bioavailability of epoxyeicosatrienoic acids is associated with conduit artery endothelial dysfunction in type 2 diabetic patients. Cardiovasc Diabetol. 2019 Mar 18;18(1):35. doi: 10.1186/s12933-019-0843-z.

family: Duflot

full_name: Thomas Duflot

given: Thomas

family: Moreau-Grangé

full_name: Lucile Moreau-Grangé

given: Lucile

family: Roche

full_name: Clothilde Roche

given: Clothilde

family: Iacob

full_name: Michèle Iacob

given: Michèle

family: Wils

full_name: Julien Wils

given: Julien

family: Rémy-Jouet

full_name: Isabelle Rémy-Jouet

given: Isabelle

family: Cailleux

full_name: Anne-Françoise Cailleux

given: Anne-Françoise

family: Leuillier

full_name: Matthieu Leuillier

given: Matthieu

family: Renet

full_name: Sylvanie Renet

given: Sylvanie

family: Li

full_name: Dongyang Li

given: Dongyang

family: Morisseau

full_name: Christophe Morisseau

given: Christophe

family: Lamoureux

full_name: Fabien Lamoureux

given: Fabien

family: Richard

full_name: Vincent Richard

given: Vincent

family: Prévost

full_name: Gaëtan Prévost

given: Gaëtan

family: Joannidès

full_name: Robinson Joannidès

given: Robinson

family: Bellien

full_name: Jérémy Bellien

given: Jérémy

journal_name: Cardiovascular Diabetology

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


title: Comparison of Two Extracorporeal Liver Support System (With or Without Recirculation) : MARS (Molecular Adsorbents Recirculating System) Versus SPAD (Single Pass Albumin Dialysis) in Severe Liver Failure.

acronym: MARSPAD

summary:
A critical issue of the clinical syndrome in liver failure is the accumulation of toxins not cleared by the failing liver. Based on this hypothesis, albumin dialysis is used to remove those substances. Albumin dialysis with recirculation (MARS) is the most used system but required specific system and expert environment. Alternative system without recirculation (SPAD) is less expensive and can be realised in critical care services trained to extrarenal epuration. The primary objective of this study is to compare biological and clinical efficacy, pulsatility index of middle cerebral artery modification and tolerance of both systems.

This is a prospective, open, cross-over comparative study of two albumin dialysis system. Each patient will receive the two systems in an randomly assessed order. Patients are divided up according to bilirubin plasmatic level. (250µmol/L to 400 µmol/L and >400µmol/L).

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital de la Croix Rousse - Service de réanimation chirurgicale


type: Registry Identifier

title: Prospective Evaluation of the Impact of Pre-operative Device on the Personal Experience of Brain Awake Surgery: Comparative Study, Randomized

acronym: EVECHE

summary:
The brain awake surgery has recently boomed in neurosurgical oncology but also in epilepsy surgery. The goal of awake surgery is to allow a more precise localization of sensorimotor functions, languages and cognitive to better respect them. Indeed, the interindividual anatomo-functional variations, the lack of specificity of functional explorations radiological magnetic or nuclear, as well as the reorganization of the areas involved in these functions (mechanisms of brain plasticity) in epileptic patients or patients with cerebral tumor do not allow to identify them in preoperatively. Brain awake surgery allows an analysis and a precise real-time identification of areas and networks involved in these functions through a direct electrical stimulation (inhibitory or activatory). Thus, this surgical technique has become a gold standard in surgery of brain lesions located in functional areas.

However, although the brain awake surgery has been practiced since many years, the confidentiality of these informations until recent years explains probably that very little data to be available on the personal experience of this procedure by patients. Studies that have analyzed the perception of the patient or the satisfaction of the patient after surgery in awake conditions were retrospective and included few patients. The investigators experience of lived of this surgery that the investigators have developed in the investigators team since over four years is that on the whole awake surgery is well tolerated if adequate explanations are provided preoperatively and if a minimum of preoperative precautions are observed.

Thus, the investigators have decided to develop a preoperative device that could improve personal experience and well-being of patients undergoing this surgical approach.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: REBECCA: A Cohort Study of Regorafenib in the Real-life Setting in Patients Previously Treated for Metastatic Colorectal Cancer.

acronym: REBECCA

summary: This is a largest cohort study aimed to estimate the overall survival of patients been treated with regorafenib for metastatic colorectal cancer (mCRC) within the frame of a french compassionate program.

ReferenceCitation: Adenis A, de la Fouchardiere C, Paule B, Burtin P, Tougeron D, Wallet J, Dourthe LM, Etienne PL, Mineur L, Clisant S, Phelip JM, Kramar A, Andre T. Survival, safety, and prognostic factors for outcome with Regorafenib in patients with metastatic colorectal cancer refractory to standard therapies: results from a multicenter study (REBECCA) nested within a compassionate use program. BMC Cancer. 2016 Jul 7;16:412. doi: 10.1186/s12885-016-2440-9. Erratum in: BMC Cancer. 2016 Jul 25;16(1):518.

family: Adenis

full_name: Antoine Adenis

given: Antoine

family: de la Fouchardiere

full_name: Christelle de la Fouchardiere

given: Christelle

family: Paule

full_name: Bernard Paule

given: Bernard

family: Burtin

full_name: Pascal Burtin

given: Pascal

family: Tougeron

full_name: David Tougeron

given: David

family: Wallet

full_name: Jennifer Wallet

given: Jennifer

family: Dourthe

full_name: Louis-Marie Dourthe

given: Louis-Marie

family: Etienne

full_name: Pierre-Luc Etienne

given: Pierre-Luc

family: Mineur

full_name: Laurent Mineur

given: Laurent

family: Clisant

full_name: Stéphanie Clisant

given: Stéphanie

family: Phelip

full_name: Jean-Marc Phelip

given: Jean-Marc

family: Kramar

full_name: Andrew Kramar

given: Andrew

family: Andre

full_name: Thierry Andre

given: Thierry

journal_name: BMC Cancer

lead_sponsor: Centre Oscar Lambret


title: Pilot Study of Exosomes Before and After BRAF Inhibitor Therapy in Patients With Advanced Unresectable or Metastatic BRAF Mutation-positive Melanoma

acronym: EXOSOMES

summary:
Recent progresses have been made in the treatment of metastatic melanoma, nevertheless improved patient survival is still limited because of primary resistance and relapses. It is therefore important to continue to understand the molecular mechanisms involved in melanoma development and progression to improve the management of patients.

Drugs such as the alkylating agents (temozolomide and fotemustine) or vemurafenib trigger senescence-like phenotypes in melanoma cells. It is now known that senescent cells secrete some factors that exert a pro-tumoral role but the potential existence and the role of insoluble factors remain undetermined.

Preliminary results from the investigators laboratory indicate the presence in the senescent secretome of exosomes; microvesicles involved in intercellular communication, immunomodulatory functions, and tumorigenesis. Several studies showed that these vesicles shape the tumor microenvironment and contribute to the migration of cancer cells.

Their interest in oncology as a prognostic factor and marker of therapeutic response is increasing.

Thus, our project aims to study the effect of exosomes produced by senescent melanoma cells in the development and progression of melanoma in vitro and in vivo using cell cultures and animal models.

In addition, the investigator propose a pilot study whose objective is to determine the effect of vemurafenib on nanovesicles produced by patients with advanced unresectable or metastatic melanoma.

The investigator hope to show that exosomes participate in the process of drug resistance and relapse, with the goal of developing (with the exosomes study) theranostic tools for personalized care in patients.

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Biological


title: Obesity Cohort : Medical Follow-up of Severe or Morbid Obese Patients Undergoing Bariatric Surgery

acronym: BAREVAL

summary: The aim of this cohort is to evaluate the follow-up of morbidly obese patients treated by several types of bariatric procedures. In addition, this study could lead to the development of clinical trials on assessment of the bariatric surgery impact.


title: Study of the GORE® EXCLUDER® Endoprosthesis in the Treatment of Infra-renal Abdominal Aortic Aneurysms

summary: This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® Excluder® Endoprosthesis in the treatment of infra-renal Abdominal Aortic Aneurysms (AAA).

lead_sponsor: W.L.Gore & Associates


title: Disruption of Circadian Rhythm and Healthcare-related Infection in Patients With Severe Trauma

summary:
Circadian rhythms, which play crucial roles in physiology, are emerging as important regulators of specific immune functions. Hospitalization in intensive care unit leads to a deep impairment of circadian rhythm. Infection is a frequent event during ICU hospitalization.

The investigators hypothesis is that in trauma patients the lack of circadian rhythm variations is associated with the occurrence of infection. The primary aim of the study is to assess the circadian variations of plasma Bmal1 in the occurrence of healthcare related infection during the 30 days after inclusion. The secondary aims are to assess the plasma expression of circadian genes (Clock, Cry1, Per3, and Rev-erba), the production of cytokines in plasma, and the concentration of cortisol, according to the occurrence of an infection.

ReferenceCitation: Coiffard B, Diallo AB, Culver A, Antonini F, Hammad E, Leone M, Mege JL. Exacerbation of circadian rhythms of core body temperature and sepsis in trauma patients. J Crit Care. 2020 Dec;60:23-26. doi: 10.1016/j.jcrc.2020.07.010. Epub 2020 Jul 16.

family: Coiffard

full_name: Benjamin Coiffard

given: Benjamin

family: Diallo

full_name: Aissatou B. Diallo

given: Aissatou B.

family: Culver

full_name: Aurélien Culver

given: Aurélien

family: Antonini

full_name: François Antonini

given: François

family: Hammad

full_name: Emmanuelle Hammad

given: Emmanuelle

family: Leone

full_name: Marc Leone

given: Marc

family: Mege

full_name: Jean-Louis Mege

given: Jean-Louis

journal_name: Journal of Critical Care

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier


title: Contributions From the Analysis of Graphs for Identification of Neural Cliques

acronym: BRAINGRAPH

summary: The aim of the study is to demonstrate that our semantic knowledge (elements of our long-term memory and the process we use them) respond to a graphic organisation and gather together following accurate patterns called cliques (neural networks).

lead_sponsor: Rennes University Hospital


title: Effect of Perioperative Factors on the Analgesia Nociception Index

acronym: ANIFACT

summary: The Analgesia Nociception Index (ANI) is a new unitless marker derived from Heart Rate Variability spectral analysis, ranging between 0 and 100 and expressing the parasympathetic tone. The ANI is proposed as surrogate marker for the analgesia nociception balance. However, many perioperative factors such as medications, position, maneuvers may influence the ANI values and may lead to misinterpretation. Moreover the ability of the ANI to guide opioid dosing has never been tested. Therefore, the aim of our study is to collect in a database all the perioperative factors and to study their influence on the ANI.


title: Impact of an Intensive Care Unit Diary on Long-term Quality of Life After Severe Trauma

acronym: Qualitrau

summary: Treatment of severe trauma patients includes intensive cares. Both trauma and intensive care may lead to a post-traumatic stress disorder and then to a decreased quality of life. Diaries may improve the frequency and the intensity of PTSD. Aim of investigator is to assess if diaries may improve quality of life after a severe trauma.

location_facility: Département d'Anesthésie-Réanimation Groupe Hospitalier Pitié Salpêtrière


title: Prospective, Randomized, Multi-center Trial Aiming to Determined the Impact of Changeovers of Norepinephrine on the Blood Pressure Stability With Patients in Shock in ICU.

acronym: CHIC

summary:
CHIC study's purpose is to compare the efficiency, in terms of blood pressure stability, of three changeovers of norepinephrine used routinely in ICU. The three techniques are:

Quick change
Double pumping
Smart infusion pumps

ReferenceCitation: Poiroux L, Le Roy C, Ramelet AS, Le Brazic M, Messager L, Gressent A, Alcourt Y, Haubertin C, Hamel JF, Piquilloud L, Mercat A. Minimising haemodynamic lability during changeover of syringes infusing norepinephrine in adult critical care patients: a multicentre randomised controlled trial. Br J Anaesth. 2020 Oct;125(4):622-628. doi: 10.1016/j.bja.2020.06.041. Epub 2020 Jul 29.

family: Poiroux

full_name: Laurent Poiroux

family: Le Roy

full_name: Cyril Le Roy

given: Cyril

family: Ramelet

full_name: Anne-Sylvie Ramelet

given: Anne-Sylvie

family: Le Brazic

full_name: Mélaine Le Brazic

given: Mélaine

family: Messager

full_name: Leslie Messager

given: Leslie

family: Gressent

full_name: Amélie Gressent

given: Amélie

family: Alcourt

full_name: Yolaine Alcourt

given: Yolaine

family: Haubertin

full_name: Carole Haubertin

given: Carole

family: Hamel

full_name: Jean-François Hamel

given: Jean-François

family: Piquilloud

full_name: Lise Piquilloud

given: Lise

family: Mercat

full_name: Alain Mercat

given: Alain

journal_name: British Journal of Anaesthesia

oa_host_type: publisher

evidence: open (via free pdf)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific


title: Evaluation of Body Iron Stores in Overweight Healthy Volunteers

acronym: FERNORM

summary: Normal body iron store value in overweight subjects is currently not described in literature. The comparison of this value with body iron levels in patients suffering from dysmetabolic iron overload syndrome (DIOS) could allow to quantify iron overload in this condition. The purpose of the study is to determine iron levels in healthy overweight volunteers, and to compare them to DIOS patients treated with phlebotomy.


title: Study of Inflammatory Markers (VNN1) in Crohn Disease and Ulcerative Colitis

acronym: VANIN

summary:
Inflammatory Bowel diseases (IBD) include Crohn's disease and ulcerative colitis. IBD's precise origin is unknown until now. Today, the current hypothesis of the disease pathogenesis is that IBD result from a dysregulated mucosal immune response to the gut microbial flora in genetically susceptible hosts. The intestinal homeostasis depends on interactions between immune and epithelial cells. Epithelial cells are the first line of defense, are tightly connected to the underlying gut associated lymphoid tissue and their alteration results in loss of tissue homeostasis.

Vanin-1 (Vnn1 in mice, VNN1 in humans) is an epithelial pantheinase which regulates the cell response to stress.

This ectoenzyme hydrolyses the vitamin B5-derivative pantetheine to provide cysteamine to tissues and regenerate pantothenate. Previous studies have shown that Vnn1 KO mice were more resistant to experimental colitis and administration of cystamine (oxidized form of cysteamine) restored their susceptibility to colitis. Furthermore, analysis of VNN1 expression in IBD patients show that high VNN1 expression is associated with severe clinical features. Thus, analysis of VNN1 expression could represent a good prognostic marker.

In a recent published article, we characterized among a retrospective cohort of 500 IBD patients and controls new SNPs (single nucleotide polymorphisms) in the VNN1 promoter and showed their association with IBD incidence and high VNN1 expression. This suggested that the VNN1gene might be a new predisposition marker of IBD.

In mouse, Vnn1 expression is tightly regulated by activation of PPARa and PPARg transcription factors. Interestingly, one of the SNPs identified in patients participates to a PPARg binding site. Interestingly, drugs related to the family of 5-ASA which are commonly used in IBD, have PPARgamma agonist potential. Therefore, quantifying VNN1 levels in patients under 5-ASA therapy might help predicting response to therapy and select patients with the highest benefit for this therapy.

The purpose of this new project is to extend our initial analysis. The study will be prospective, monocentric and controlled. Its primary objective is to evaluate the level of VNN1 expression in the colonic mucosa between IBD patients and control subjects to confirm the correlation between high VNN1 expression and IBD. In relation with its prospective nature, we will also try to associate VNN1 expression level with specific endophenotypes (severity and/or localization of the lesions, quality of the response to therapy). Finally, we will screen patients for the previously identified SNPs to integrate this information in the interpretation of the results of expression analysis.

This study is planned on 2 years. Two groups of patients will be constituted: one group will include IBD patients followed in the " Service de Gastro-entérologie du Pr Grimaud à l'Hôpital Nord " and the other group will constitute the control cohort including persons who were proposed a screening colonoscopy for familial history of colon cancer or polyps, or for Irritable Bowel Syndrome.

The investigator will have to fill a questionnaire for each included patient, collecting information about age, sex, past medical history, taken medicine, digestive symptoms and colonoscopy indication.

IBD patients will have a first set of biopsies (n = 10) and blood samples collected under general anesthesia during a colonoscopy planned in their IBD usual follow-up; a second set of similar samples will be collected within the next 12 months if an endoscopic control is medically justified. The control subjects will have only one set of biopsy and blood samples collected under general anesthesia during their colonoscopy. In the particular case of IBD patients who require surgery, a small piece of the resection will be collected ex-vivo on both healthy and pathologic areas.

The blood sample will serve for quantification of the VNN1 seric pantheteinase activity and SNP's genetic study.

The colonic biopsies will be obtained in duplicates from 5 different ileocolonic areas, one for histopathological analysis and the other for transcriptional analysis by qRT-PCR.

The surgical samples will be used for transcriptional activity, tissue pantheteinase activity and constitution of TMA (Tissue MicroArrays) bank for immunohistochemistry.

Expected benefits are to validate a new IBD prognostic marker for disease severity or potentially for evaluation of the therapeutic response.


title: Feasibility of Superior Rectal Artery Embolization for the Treatment of Hemorrhoidal Disease

acronym: EMBORRHOID

summary:
With an estimated prevalence between 4 and 35%, the hemorrhoidal disease is the most frequent proctologic disease. Its symptoms are mainly rectorrhagia, externalization of the hemorrhoidal cushions (muco-hemorrhoidal prolapse), and/or pain and pruritus. Its acute complications (external and/or internal thromboses) are unpredictable.

Surgical treatment concerns approximately 10% of patients with diagnosed hemorrhoidal pathologies. The elective ligature of the arteria haemorrhoidalis under trans-anal Doppler scanning was developed in order to reduce the postoperative morbidity of hemorrhoidal surgery. This technique consists in a ligation of the superior rectal artery under Doppler control in order to decrease the blood flow within the hemorrhoids and therefore to reduce them. It is effective in the treatment of internal hemorrhoidal pathology without prolapse (grade II). The complications rate is low and estimated between 2 and 12% : rectorrhagia (4.3%), thrombosed hemorrhoids (1,8%), fissure (0,8%), acute urine retention (0,7%).

With the major advances in interventional radiology such ligation could be performed by an endovascular coil embolization. Until now no direct study exists on the subject but several case reports show the feasibility of an embolization of the superior rectal arteries for rectorrhagia of various etiologies such as the hemorrhoidal disease.

Endovascular access should increase the selectivity of the embolization compared to the Doppler scanning technique. Indeed the arteriography makes it possible to scan all branches of the superior rectal artery and therefore to occlude permanently the branches that feed the hemorrhoidal plexuses. Moreover the endovascular embolization technique should avoid the main complications of the trans-anal access technique.

The primary objective of this study is : the assessment of the efficacy of endovascular coil embolization of the superior rectal arteries in the management of the symptoms of the hemorrhoidal disease grade II and III. The secondary objective is : the assessment of postoperative complications.

location_facility: Assistance Publique Hopitaux de Marseille


title: Study of the Prevalence of Pre-existing Immunity Against the Adeno-associated Virus (AAV) in Patients With Crigler-Najjar Syndrome

summary: The proposed research protocol aims at addressing these points by pre-screening CN patients for their AAV serology in link with their medical history and current medical status. A first objective is to assess the presence of neutralizing AAV antibodies in the serum of CN patients.

lead_sponsor: Genethon


title: Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA)

acronym: MOR-FO-SIA

summary:
Adolescent idiopathic scoliosis (AIS) is a complex deformity with different curves. These different curves may be distinguished by different physiopathologic mechanisms.

Without fully convincing model of the emergence and development of AIS, their multifactorial nature seems evident. Several pathophysiological theories involving the central nervous system have been proposed: the AIS would be associated with disturbances of proprioceptive or sensory perception, and/or with integration of this information. This would result in an abnormal body image, responsible for sensorimotor asymmetry that may promote or cause the deformation.

The Main aim of this study is to find cortical and subcortical morphometric differences in the most common population of AIS (right thoracic AIS) compared to healthy adolescent control girls.

Secondary Objectives are to study the cerebral white matter of the same groups (fractional anisotropy in the main white matter tracts), and activation of sensorimotor neural networks (fMRI activation and functional brain connectivity).

Abnormalities of the studied parameters may be used as biomarkers for AIS diagnosis and classification.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Tours


title: Pilot Study of the ANI (Analgesia Nociception Index) Validity on the Nociception Assessment in Healthy Volunteers in State of Hypnosis, Compared to Painful Numerical Verbal Scale (EVN).

summary:
Healthy subjects should assess pain on a numerical scale (EN), during painful skin stimuli of variable intensity delivered by a CO2 laser used at the power of 0.3 W, known for its safety. ANI (Analgesia Nociception Index) will be raised simultaneously. This sequence will be made on subjects at rest and in a state of hypnosis using the technique of "remembering a pleasant memory" and the ideo-sensory technique of "protective glove".

The average value of the ANI will be compared to the value of the EVN of pain intensity.

lead_sponsor: University Hospital, Brest


title: Interest of the Not Invasive Ventilation Used in Meadow and Post-operative of Cardiac Surgery, in Disease Prevention of the Cardiac and/or Lung Complications at the Patients at Risk.

acronym: CAPVNI

summary:
After cardiac surgery, many complications can arise, in particular at the cardiac and lung level and it is true especially as the patient is with comorbidity. A patient will be considered at risk of a cardiac surgery if risk factors are present in preoperative (obesity, Chronic obstructive pulmonary disease (COPD), etc...). The non-invasive ventilation (NIV)developed these last years in the treatment of acute cardiac insufficiency and the hypercapnic COPD exacerbations; its use is more and more envisaged in cardio-thoracic and abdominal surgery services.

Studies showed that the NIV allowed an improvement of the oxygenation, the lung volumes and a decrease of ventilation work. According to these observations, the preventive NIV could reduce the incidence of appearance of the lung and/or cardiac complications at the patients to risk. we estimate 40 to 50%of cardiac surgery patients at a high risk level and we expect to obtain a benefit with this particular population. If we meet our goal (a significant difference in terms of morbi-mortality with the preventive NIV versus classical care), we expect the systematisation of this procedure to all cardiac surgery high risk patients.


title: Automatic Oxygen Administration in Spontaneous Ventilation During the Hypoxemic Acute Respiratory Distress in Infants and Children

summary:
The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in infants and children admitted at hospital for hypoxemic acute respiratory distress.

In healthy volunteers adults, FreeO2 system provided a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. Our hypothesis is that FreeO2 system use is feasible in infants and children with hypoxemic acute respiratory distress. We think FreeO2 will provide a better control of the oxygen saturation, a faster oxygen weaning than classical way (Rotameter). In addition, FreeO2 could reduce the number of intervention by nurses.

ReferenceCitation: Roué JM, Delpeut J, d'Hennezel A, Tierrie T, Barzic A, L'Her E, Cros P. Automatic oxygen flow titration in spontaneously breathing children: An open-label randomized controlled pilot study. Pediatr Pulmonol. 2020 Nov;55(11):3180-3188. doi: 10.1002/ppul.25035. Epub 2020 Aug 31.

name: Department of Pediatrics Brest University Hospital  Brest France

family: Roué

full_name: Jean‐Michel Roué

given: Jean‐Michel

family: Delpeut

full_name: Juliette Delpeut

given: Juliette

family: d‘Hennezel

full_name: Alix d‘Hennezel

given: Alix

family: Tierrie

full_name: Tess Tierrie

given: Tess

family: Barzic

full_name: Audrey Barzic

given: Audrey

name: Department of Medical Intensive Care Brest University Hospital  Brest France

family: L'Her

full_name: Erwan L'Her

given: Erwan

family: Cros

full_name: Pierrick Cros

given: Pierrick

journal_name: Pediatric Pulmonology

title: Automatic oxygen flow titration in spontaneously breathing children: An open‐label randomized controlled pilot study


title: Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache With or Without Abuse of Painkillers

summary:
Chronic headache is most often associated with drug abuse and medication overuse headache (MOH) is the main complication of migraine disease results in chronic daily headache. The first phase of treatment consists of drug withdrawal .

The second phase of treatment (called consolidation) is to maintain the balance: treating headaches and reducing / stopping the drug use.

The aim of this study is

verify the feasibility of a home withdrawal treatment with normobaric oxygen therapy (NOT) delivery by high flow concentrator
use normobaric oxygen therapy (NOT) as a therapeutic measure to treat headache through withdrawal period.

It is a feasibility pilot study in chronic headache with or without medication-overuse. All patients receive a care for outpatient withdrawal that involves sudden stop drug abuse and used to be called "traditional management". The subsequent attacks will be treated with NOT from a high-flow concentrator

Primary endpoint. Feasibility study of treatment with NOT evaluated by the percentage of patients who accepted NOT during the withdrawal phase then to treat attacks.

Secondary endpoints. Efficacy will be assessed by the percentage of patients having no chronic headaches two months after the start of withdrawal (less than 15 days of headache per month) and no longer in drug abuse (less than 10 days per month with drug intake).

Visits V1 (first visit) Inclusion V2 at one month V3 at 3 months V4 (last vist) at 6 months

Effective : 30 patients

ReferenceType: result

ReferenceCitation: Kavuk I, Katsarava Z, Selekler M, Sayar K, Agelink MW, Limmroth V, Diener HC. Clinical features and therapy of medication overuse headache. Eur J Med Res. 2004 Dec 22;9(12):565-9. Review.

ReferenceCitation: Lantéri-Minet M, Valade D, Géraud G, Chautard MH, Lucas C. Migraine and probable migraine--results of FRAMIG 3, a French nationwide survey carried out according to the 2004 IHS classification. Cephalalgia. 2005 Dec;25(12):1146-58.

ReferenceCitation: Evers S, Marziniak M. Clinical features, pathophysiology, and treatment of medication-overuse headache. Lancet Neurol. 2010 Apr;9(4):391-401. doi: 10.1016/S1474-4422(10)70008-9. Review.

family: Evers

full_name: Stefan Evers

given: Stefan

family: Marziniak

full_name: Martin Marziniak

given: Martin

journal_name: The Lancet Neurology

lead_sponsor: Association pour la Recherche au Centre d'Urgence des Céphalées

location_facility: Centre d'Urgence des Céphalées, hôpital Lariboisière


title: Effects of Intranasal Oxytocin on Emotion Regulation to Stressful Interaction in Insecure Adolescents: a Study Protocol for a Double Blind Randomized Controlled Trial

acronym: ELOREA

summary: The purpose of this study is to determine the effect of intranasal administration of OT on behavior and discourse of insecure adolescents during a disagreement (stressful situation) with parents.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: A Study to Investigate the Effects of T4P1001 Treatment in Patients With Peripheral Neuropathic Pain

summary: The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response.

location_facility: CIC Clermont-Ferrand, CHU Clermont-Ferrand


title: Pretargeted Radioimmunotherapy in Metastatic Colorectal Cancer : A Multicentric Phase I/II Study of Fractionated TF2 Plus 90Y-IMP288 (RITCOLON)

acronym: RITCOLON

summary: Phase I/II, Open-labeled, Prospective, Multi-center study of a Pretargeted Radioimmunotherapy in metastatic colorectal cancer with ractionated injections of TF2 plus 90Y-IMP288 (RITCOLON).

lead_sponsor: Nantes University Hospital


title: Thrombin Generation Numerical Models Validation in Haemophilic Case

summary: Personalized therapy in haemophilia has not been reached yet. Treatment is substitutive and its doses are only based on the levels of deficient factor VIII (for haemophilia A) or IX (for haemophilia B). The bleeding severity is not only related to the factor deficiency but also to levels of other coagulation factors (e.g. factor X, II, AT or TFPI). It's necessary to take them into account in order to individualize treatments; and Thrombin Generation Assay (TGA) with the CAT method (Calibrated Automated Thrombography) is a good way because it measures the result of the coagulation cascade. TGA on Platelet Rich Plasma (PRP) is even closer to physiological conditions than on Platelet Poor Plasma (PPP) because platelet influence is represented. It has already been shown (at least in PPP) that the bleeding tendency in haemophilic patients is usually well correlated to TG. Some TG parameters are used to characterize the individual coagulation phenotype, the most important being the Endogenous Thrombin Potential (ETP) and the Lag Time (LT). A hemorrhagic profile usually provides a longer lag time and / or a lower ETP. However, only few studies tried to determine the influence of each coagulation factor and inhibitor on TG. They were done on Platelet Poor Plasma (PPP) or on lyophilized plasma. So the relation between coagulation factors and the different TG parameters remains to be determined, especially in the haemophilic case. It is possible, experimentally, to find the optimal dose of the factor to be added by measuring TG in samples with different factor VIII or IX concentrations, but this method would be time consuming and expensive, especially because it should be done for each haemophilic patient. A better way consists in using TG numerical models. For a set of initial factor levels they simulate the TG and its associated parameters. It is now essential to validate the existing models, especially in haemophilic cases, in order to see whether they are reliable and can be used in clinical practice afterwards.The objective of this study is to validate thrombin generation numerical models which could predict the factor VIII or IX activity correction to reach a thrombin generation sufficient to avoid bleeding. A comparison between the TG observed in haemophilic patients and the TG predicted by the models is needed to validate the models. In order to define a 'safe' TG i.e. sufficient to avoid bleeding, normal ranges of TG parameters have to be measured.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Comparison of Sensitivity Between Presepsine and Arterial Lactate for the Diagnosis of Severe Sepsis and Sepsis Shock in Emergency Department.

acronym: PREDI

summary:
Severe sepsis and sepsis shock are common in emergency department, with a high mortality rate. The potential severity of this disease impose a diagnosis as early as possible to start antibiotic therapy and hemodynamic support. Conventional biomarkers are an important support for the emergency physician. However, comparison of sensitivity and specificity for new biomarkers, like presepsine, suggests that they can be more efficient in this area.

In this single-center, prospective, non-interventional study, we propose to compare the sensitivity of presepsine to that of lactate for the diagnosis of severe sepsis and septic shock We emit to main hypothesis that the sensitivity of presepsine is higher than that of lactate for the diagnosis of severe sepsis.


title: Automatic Detection and Characterization of Residual Masses in Patients With Lymphomas Through Fusion of Whole-Body Diffusion-Weighted MRI on 3 Tesla and 18F-Fluorodeoxyglucose PET/CT

acronym: ADAMANTIUS

summary: The present study aims to further optimize a whole-body Diffusion-Weighted Magnetic Resonance Imagery (DW-MRI or DWI) protocol on 3 Tesla MR and/or new system combining 3Tesla MR and Positron Emission Tomography (PET), to develop and validate an automated whole-body parametric image analysis algorithm, and to determine the added value of whole-body DWI to Fluorodeoxyglucose-PET for the management of lymphoma patients.

lead_sponsor: The Lymphoma Academic Research Organisation


title: Designing a Bayesian Model of the Plasma Clearance of Calcium Edetate de Sodium, With a Limited Sampling Strategy for the Calculation of Glomerular Filtration Rate (GFR) and Validity Assessment Compared to the Renal Clearance of Inulin : DFGBay

acronym: DFGBay

summary:
Diagnosis of patients with renal insufficiency and recommendations for medical treatment of patients who suffer from chronic renal failure are based on the different stages of Glomerular Filtration Rate (GFR). Many formulas exist to assess GFR. However these formulas are unreliable in many clinical situations (old people, obese patients…). Methods for measuring GFR using exogenous tracers exist: Inulin and 51Cr-EDTA are historical reference tracers. Renal clearance of Inulin is the gold standard. However, using these methods is restricted to specialized services because it is long and expensive.

There is no medical data for the use of Calcium edetate de sodium as a tracer to assess GFR. Calcium edetate de sodium is a treatment for lead intoxication. The extension of use as a tracer comes from its exclusive elimination by glomerular filtration.

Plasma and renal clearance of Calcium edetate de sodium and Inulin will be measured for every included patient during a hospital day care (First visit V1). For transplanted patients, plasma clearance of Calcium edetate de sodium will be repeated within one week (more or less 48hours) during annual medical check-up of renal transplantation (Second visit V2).

lead_sponsor: University Hospital, Limoges


title: Safety of Intranasal Fentanyl (PecFent®) in the Treatment of Procedural Pain in the Elderly With or Without Background Treatment.

acronym: FENTA

summary: The purpose of this study is to evaluate the safety of the intranasal fentanyl in pain induced by wound care and rehabilitation in the elderly. The project would also provide a preliminary assessment of the effectiveness of intranasal fentanyl used in procedural pains.

lead_sponsor: University Hospital, Grenoble


title: Impact of Fas/FasL in Chemotherapy Response in Epithelial Ovarian Carcinoma

acronym: IFFaLCCO

summary: Ovarian carcinoma has poor prognosis and new therapeutic strategies are required. Many patients with ovarian carcinoma showed resistance to chemotherapy. Cleaved FasL is known for induced atypical response when is binding to Fas such as avoiding apoptosis and inducing cell motility.


title: Effects of Beverages Containing Low Calorie Sweeteners (LCS) on Energy and Macronutrient Intakes and on Hunger, Appetite and Satiety Sensations

summary: Although there is evidence that low calorie sweeteners (LCS) do not stimulate hunger or appetite, divergent opinions appear regularly both in the scientific literature and in the popular press. The goal of this study is to examine the effects of LCS containing beverages on appetite and intake in healthy individuals.

ReferenceCitation: Fantino M, Fantino A, Matray M, Mistretta F. Beverages containing low energy sweeteners do not differ from water in their effects on appetite, energy intake and food choices in healthy, non-obese French adults. Appetite. 2018 Jun 1;125:557-565. doi: 10.1016/j.appet.2018.03.007. Epub 2018 Mar 9.

family: Fantino

full_name: Marc Fantino

given: Marc

full_name: Agnès Fantino

given: Agnès

family: Matray

full_name: Marie Matray

given: Marie

family: Mistretta

full_name: Frédéric Mistretta

given: Frédéric

bso_classification: Biology (fond.)

journal_name: Appetite

evidence: open (via crossref license)

lead_sponsor: The Coca-Cola Company

location_facility: CreaBio Rhône-Alpes laboratory, 9 avenue du Professeur Fleming


title: Efficacy Study of an Olfactory Stimulation Program in Relaxing Environment for the Recuperation of Autobiographical Memories in Anorexic Patients

acronym: OLFANOR

summary: The purpose of this study is to estimate the impact of an olfactive stimulation, in relaxing environment, on the access at the autobiographical memories in anorexic patients.

lead_sponsor: Lille Catholic University

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille


title: Monocentric STUDY, Randomised Double Blinded (Healthy Subjects, or Transversal (Patients With Gitelman Syndrome)

acronym: DEPROGE

summary: Progesterone is needed to permit adaptation of the kidney to limit potassium loss in the urines. The investigators wonder whether progesterone or other adrenal hormon play the same role. The investigators will investigate surrenal hormone production in healthy subjects under a 7-day potassium depleted diet and in patients chronically hypokalaemic due to a renal loss of potassium.

ReferenceCitation: Elabida B, Edwards A, Salhi A, Azroyan A, Fodstad H, Meneton P, Doucet A, Bloch-Faure M, Crambert G. Chronic potassium depletion increases adrenal progesterone production that is necessary for efficient renal retention of potassium. Kidney Int. 2011 Aug;80(3):256-62. doi: 10.1038/ki.2011.15. Epub 2011 Feb 16.

ReferenceCitation: Blanchard A, Brailly Tabard S, Lamaziere A, Bergerot D, Zhygalina V, Lorthioir A, Jacques A, Hourton D, Azizi M, Crambert G. Adrenal adaptation in potassium-depleted men: role of progesterone? Nephrol Dial Transplant. 2020 Nov 1;35(11):1901-1908. doi: 10.1093/ndt/gfz135.

name: Université Paris Descartes, Sorbonne Paris Cité, Paris, France

name: Assistance Publique Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Centre d’Investigation Clinique, Paris, France

family: Blanchard

full_name: Anne Blanchard

given: Anne

name: Faculté de Médecine Paris-Sud, Université Paris-Saclay, Le Kremlin-Bicêtre, France

name: Assistance Publique Hôpitaux de Paris, Hôpital de Bicêtre, Service de Génétique Moléculaire, Pharmacogénétique et Hormonologie, Le Kremlin-Bicêtre, France

name: Inserm 1185 Faculté de Médecine Paris-Sud, Paris-Saclay, Le Kremlin-Bicêtre, France

family: Brailly Tabard

full_name: Sylvie Brailly Tabard

given: Sylvie

name: Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Antoine, Plateforme de Métabolomique, Peptidomique et de Dosage de Médicaments, Paris, France

name: INSERM ERL1157, Le Kremlin-Bicêtre, France

family: Lamaziere

full_name: Antonin Lamaziere

given: Antonin

family: Bergerot

full_name: Damien Bergerot

given: Damien

family: Zhygalina

full_name: Valentina Zhygalina

given: Valentina

family: Lorthioir

full_name: Aurélien Lorthioir

given: Aurélien

name: Assistance Publique Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Unité de recherche clinique, Paris, France

family: Jacques

full_name: Antoine Jacques

given: Antoine

family: Hourton

full_name: Delphine Hourton

given: Delphine

family: Azizi

full_name: Michel Azizi

given: Michel

name: Sorbonne Université, INSERM, Université Paris Descartes, Sorbonne Paris Cité, UMR_S 1138, Centre de Recherche des Cordeliers, F-75006, Paris, France

name: CNRS ERL 8228—Centre de Recherche des Cordeliers—Laboratoire de Physiologie Rénale et tubulopathies, Paris, France

family: Crambert

full_name: Gilles Crambert

given: Gilles

journal_name: Nephrology Dialysis Transplantation

oa_host_type: repository

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

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Dietary Supplement


title: Anatomical and Functional Results of Surgery of the Tympanic Membrane Perforation of the Child

acronym: PERFOPED

summary: This study is a retrospective cohort of patients minors during the operation of cartilage tympanoplasty for tympanic membrane perforation

time_perspective: Retrospective


summary: The aims of the study is to assess whether the intravenous infusion of 3 mg/kg erythromycin has a significant gastrokinetic effect leading to empty the stomach in less than 90 minutes in non-fasting patients undergoing emergency trauma surgery.

lead_sponsor: Lionel Bouvet


title: Monitorage Continu du Lactate et de la glycémie Par Microdialyse : Une étude de Validation en Chirurgie Cardiaque.

acronym: MONILAG

summary: Continuous lactate and glucose blood levels

ReferenceCitation: Gouëzel C, Lorne E, Bonnet V, Fradin S, Saplacan V, Gérard JL, Hanouz JL, Fellahi JL, Fischer MO; FHT (French Hemodynamic Team). Assessment of changes in lactate concentration with intravascular microdialysis during high-risk cardiac surgery using the trend interchangeability method. Br J Anaesth. 2017 Dec 1;119(6):1110-1117. doi: 10.1093/bja/aex338.

family: Gouëzel

full_name: C. Gouëzel

given: C.

family: Lorne

full_name: E. Lorne

given: E.

family: Bonnet

full_name: V. Bonnet

given: V.

family: Fradin

full_name: S. Fradin

given: S.

family: Saplacan

full_name: V. Saplacan

family: Gérard

full_name: J -L Gérard

given: J -L

family: Hanouz

full_name: J -L Hanouz

family: Fellahi

full_name: J -L Fellahi

family: Fischer

full_name: M -O Fischer

given: M -O

lead_sponsor: University Hospital, Caen


title: LateR-Ac Study: Late Effects of Radiosurgery on Acromegaly Study

acronym: LateRAc

summary:
Transsphenoidal surgery is the first-line treatment of acromegaly. Adjunctive radiotherapy can be necessary when surgery is ineffective to avoid a prolonged medical treatment. Several studies reported long-term extra-pituitary side-effects of conventional radiotherapy. However, none has evaluated potential side-effects induced by Gamma Knife radiosurgery, a highly precise stereotactic technique, that has been used as an effective treatment of acromegaly.

Aims of the study: To determine potential long-term (superior to 10 years) extra-pituitary side-effects of Gamma Knife radiosurgery in patients treated for Acromegaly.

Methods: Transversal exposed/unexposed study. Exposed patients have been treated by Gamma Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion, whereas unexposed patients have been treated by somatostatin analogs after unsuccessful surgery for at least 10 years before inclusion. 80 Patients (40 patients/group) will be evaluated in terms of cognitive dysfunction, quality of life, secondary tumor, stroke, pituitary deficits and growth hormone control of hypersecretion. Recruitment is planned to last for 2 years.

Expected results: We should be able to determine whether Gamma Knife radiosurgery is a long-term safe technique. This result might modify the management and follow-up of patients with acromegaly unsuccessfully treated by surgery.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Determinism of the Mechanism of Action of Specific Immunotherapy in Hymenoptera Venom Allergy

acronym: MAISAVEN

summary:
Currently, most of the protocols used for desensitization to Hymenoptera venoms consist of a very rapid increase in doses of venom extracts administered during the SIT in a day without systemic reaction of the patient which is not yet explained. The hypothesis is that this good tolerance is due to a rapid decrease in the response of mast cells and basophils to the allergen..

The main objective is to study basophil activation in response to the allergen during the first day of desensitization, measured by basophil activation test.

The initiation of desensitization follow a protocol of rapid growth rates. The basophil activation level in the course of desensitization will be analyzed by flow cytometry after in vitro stimulation by allergen.

Changes in T cell polarization is also analyzed by flow cytometry. Evolution of the expression of different proteins in blood basophils will be studied by measuring their messenger RNAs

lead_sponsor: University Hospital, Rouen


title: The North-West Inter Regional Female Cohort for Patients With Endometriosi

acronym: CIRENDO

summary:
All women managed for endometriosis are included and followed up through the CIRENDO database.

Information is obtained from surgical and histological records and from self-questionnaires completed before surgery. Standardized gastrointestinal questionnaires (KESS, GIQLI, WEXNER, FIQL and Bristol) are routinely used to assess bowel function. Data recording, patient contact and follow-up are carried out by a clinical research technician. Postoperative follow-up is based on data from the afore-mentioned questionnaires completed at 1, 3, 5 and 7 years.

ReferenceCitation: Roman H, Bubenheim M, Auber M, Marpeau L, Puscasiu L. Antimullerian hormone level and endometrioma ablation using plasma energy. JSLS. 2014 Jul-Sep;18(3). pii: e2014.00002. doi: 10.4293/JSLS.2014.00002.

family: Roman

full_name: Horace Roman

given: Horace

family: Bubenheim

full_name: Michael Bubenheim

given: Michael

family: Auber

full_name: Mathieu Auber

given: Mathieu

family: Marpeau

full_name: Loïc Marpeau

given: Loïc

family: Puscasiu

full_name: Lucian Puscasiu

given: Lucian

journal_name: JSLS : Journal of the Society of Laparoendoscopic Surgeons

oa_colors: green other

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: The Society of Laparoendoscopic Surgeons

title: Antimullerian Hormone Level and Endometrioma Ablation Using Plasma Energy

ReferenceCitation: Roman H, Auber M, Bourdel N, Martin C, Marpeau L, Puscasiu L. Postoperative recurrence and fertility after endometrioma ablation using plasma energy: retrospective assessment of a 3-year experience. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):573-82. doi: 10.1016/j.jmig.2013.02.016. Epub 2013 Jun 10.

family: Bourdel

full_name: Nicolas Bourdel

given: Nicolas

family: Martin

full_name: Cécile Martin

given: Cécile

journal_name: Journal of Minimally Invasive Gynecology

title: Postoperative Recurrence and Fertility after Endometrioma Ablation Using Plasma Energy: Retrospective Assessment of a 3-Year Experience

ReferenceCitation: Roman H, Ness J, Suciu N, Bridoux V, Gourcerol G, Leroi AM, Tuech JJ, Ducrotté P, Savoye-Collet C, Savoye G. Are digestive symptoms in women presenting with pelvic endometriosis specific to lesion localizations? A preliminary prospective study. Hum Reprod. 2012 Dec;27(12):3440-9. doi: 10.1093/humrep/des322. Epub 2012 Sep 7.

full_name: H. Roman

given: H.

family: Ness

full_name: J. Ness

given: J.

family: Suciu

full_name: N. Suciu

given: N.

ReferenceCitation: Rozsnyai F, Roman H, Resch B, Dugardin F, Berrocal J, Descargues G, Schmied R, Boukerrou M, Marpeau L; CIRENDO Study Group. Outcomes of surgical management of deep infiltrating endometriosis of the ureter and urinary bladder. JSLS. 2011 Oct-Dec;15(4):439-47. doi: 10.4293/108680811X13176785203798.

title: Outcomes of Surgical Management of Deep Infiltrating Endometriosis of the Ureter and Urinary Bladder

ReferenceCitation: Bridoux V, Roman H, Kianifard B, Vassilieff M, Marpeau L, Michot F, Tuech JJ. Combined transanal and laparoscopic approach for the treatment of deep endometriosis infiltrating the rectum. Hum Reprod. 2012 Feb;27(2):418-26. doi: 10.1093/humrep/der422. Epub 2011 Dec 8.

ReferenceCitation: Auber M, Bourdel N, Mokdad C, Martin C, Diguet A, Marpeau L, Roman H. Ultrasound ovarian assessments after endometrioma ablation using plasma energy. Fertil Steril. 2011 Jun 30;95(8):2621-4.e1. doi: 10.1016/j.fertnstert.2011.04.090. Epub 2011 May 31.

ReferenceCitation: Vassilieff M, Suaud O, Collet-Savoye C, Da Costa C, Marouteau-Pasquier N, Belhiba H, Tuech JJ, Marpeau L, Roman H. [Computed tomography-based virtual colonoscopy: an examination useful for the choice of the surgical management of colorectal endometriosis]. Gynecol Obstet Fertil. 2011 Jun;39(6):339-45. doi: 10.1016/j.gyobfe.2011.04.004. Epub 2011 May 18. French.

title: Coloscanner à l’air avec coloscopie virtuelle : arguments dans le choix du traitement chirurgical des endométrioses colorectales

ReferenceCitation: Roman H, Pura I, Tarta O, Mokdad C, Auber M, Bourdel N, Marpeau L, Sabourin JC. Vaporization of ovarian endometrioma using plasma energy: histologic findings of a pilot study. Fertil Steril. 2011 Apr;95(5):1853-6.e1-4. doi: 10.1016/j.fertnstert.2010.11.038. Epub 2010 Dec 17.

ReferenceCitation: Badescu A, Roman H, Barsan I, Soldea V, Nastasia S, Aziz M, Puscasiu L, Stolnicu S. Patterns of Bowel Invisible Microscopic Endometriosis Reveal the Goal of Surgery: Removal of Visual Lesions Only. J Minim Invasive Gynecol. 2018 Mar - Apr;25(3):522-527.e9. doi: 10.1016/j.jmig.2017.10.026. Epub 2017 Oct 31.

ReferenceCitation: Darwish B, Stochino-Loi E, Pasquier G, Dugardin F, Defortescu G, Abo C, Roman H. Surgical Outcomes of Urinary Tract Deep Infiltrating Endometriosis. J Minim Invasive Gynecol. 2017 Sep - Oct;24(6):998-1006. doi: 10.1016/j.jmig.2017.06.005. Epub 2017 Jun 15.

ReferenceCitation: Roman H, Darwish B, Bridoux V, Chati R, Kermiche S, Coget J, Huet E, Tuech JJ. Functional outcomes after disc excision in deep endometriosis of the rectum using transanal staplers: a series of 111 consecutive patients. Fertil Steril. 2017 Apr;107(4):977-986.e2. doi: 10.1016/j.fertnstert.2016.12.030. Epub 2017 Jan 27.

ReferenceCitation: Roman H, Hennetier C, Darwish B, Badescu A, Csanyi M, Aziz M, Tuech JJ, Abo C. Bowel occult microscopic endometriosis in resection margins in deep colorectal endometriosis specimens has no impact on short-term postoperative outcomes. Fertil Steril. 2016 Feb;105(2):423-9.e7. doi: 10.1016/j.fertnstert.2015.09.030. Epub 2015 Oct 29.


title: Decoding of the Expression of Tumor Suppressor P2RX7 in Inflammatory and Malignant Colonic Mucosa

summary:
The inflammatory tumor micro-environment is a consequence and a driver of tumorogenesis. On one hand it promotes antitumor immune responses and on the other hand it favors development and progression of cancerous lesions.

Factors regulating the complex interplay between epithelial and immune cells are still poorly characterized. Extracellular ATP (eATP) acting on the purinergic P2X7 receptors (P2RX7) has recently emerged as a key signaling pathway in the immune response.

Recent data have revealed the crucial role of P2RX7-NLRP3-Caspase-1 for priming dendritic cells (DC) within the tumor microenvironment upon treatment with certain types of chemotherapy drugs. Despite this important discovery, no previous study has so far investigated the global in vivo effect of P2RX7 modulation in inflammation-induced carcinogenesis of mucosal tissues.

Our consortium, endowed by a long standing experience in the field of mucosal immunology, inflammation and signaling, already demonstrated that the P2RX7 is differentially expressed in the mucosa of patients with active and quiescent inflammatory bowel disease (IBD), where eATP is present at very high concentration, and that P2RX7 controls an amplification loop of the inflammatory response (Cesaro et al., 2010). Furthermore, we uncovered that P2RX7 controls homeostasis, survival and function of regulatory T cells (Hubert et al., 2010). In addition, our recent demonstration that P2RX7 deficiency lowered mucosal inflammation but unexpectedly enhanced tumor formation in vivo warrants additional efforts to explore the molecular and cellular mechanisms accounting for this effect and suggest that enhancing P2RX7 function may have an anti-tumor therapeutic effect.

These observations emphasize the tumor suppressor role of P2X7 receptor, warrant further investigation to better understand the molecular mechanisms responsible for this anti-tumor effect and suggest that enhancing the function of P2X7R could have a therapeutic effect significant antitumor.

Our main objectives is to explore the role of P2RX7 in healthy, inflammatory and cancerous colonic mucosa. For this we will map the expression of the protein P2RX7 and realize genotype of P2RX7 forms in inflammatory diseases and cancer of the colon.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation of the Action of the Stendo Pulsating Suit on Peripheral Microcirculation and on Endothelial Function in Diabetic Patients Without Complication

summary: The action of one Stendo pulsating suit session will be evaluated on 16 type 2 diabetic patients referred on the diabetic consultations. The effects of one Stendo pulsating suit session system will be assessed on the peripheral cutaneous microcirculation and on endothelial functions

lead_sponsor: Stendo

location_facility: Hôpital Jean Verdier, Service d'Endocrinologie Diabétologie Nutrition


title: Efficacy of the Ultrasound-guidedTransversus Abdominis Plane (TAP) Block on Postoperative Pain Control in Open Aortic Abdominal Aneurysm Repair Surgery

acronym: ETAP

summary: The ETAP study aim to assess the effect of the addition of an ultrasound-guided transversus abdominis plane (TAP) block to a multimodal intravenous analgesia protocol on the postoperative pain control in open surgical repair of abdominal aortic aneurysm. The ETAP study is a single-center open-label randomized controlled trial. Half of patients included will receive the association of TAP block and multimodal intravenous analgesia, and the other half will receive the multimodal intravenous analgesia alone. The multimodal intravenous analgesia includes intravenous paracetamol and intravenous patient-controlled analgesia with morphine.

ReferenceCitation: McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.

family: McDonnell

full_name: John G. McDonnell

given: John G.

family: Curley

full_name: Gerard Curley

given: Gerard

family: Carney

full_name: John Carney

given: John

family: Benton

full_name: Aoife Benton

given: Aoife

family: Costello

full_name: Joseph Costello

given: Joseph

family: Maharaj

full_name: Chrisen H. Maharaj

given: Chrisen H.

family: Laffey

full_name: John G. Laffey

journal_name: Anesthesia & Analgesia

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: The Analgesic Efficacy of Transversus Abdominis Plane Block After Cesarean Delivery: A Randomized Controlled Trial


title: Functional Outcome After Cardiac Arrest; Prediction and Prognosis Factors for Patients Awake Within the First 15 Days

acronym: HANOX

summary: Descriptive and prognosis study of the functional outcome after cardiac arrest for the patients awake within the first 15 days.

ReferenceCitation: Peskine A, Cariou A, Hajage D, Deye N, Guérot E, Dres M, Sonneville R, Lafourcade A, Navarro V, Robert H, Azouvi P, Sharshar T, Bayen E, Luyt CE; Hanox Study Group. Long-Term Disabilities of Survivors of Out-of-Hospital Cardiac Arrest: The Hanox Study. Chest. 2021 Feb;159(2):699-711. doi: 10.1016/j.chest.2020.07.022. Epub 2020 Jul 20.

family: Peskine

full_name: Anne Peskine

given: Anne

family: Cariou

full_name: Alain Cariou

given: Alain

family: Hajage

full_name: David Hajage

given: David

family: Deye

full_name: Nicolas Deye

family: Guérot

full_name: Emmanuel Guérot

given: Emmanuel

family: Dres

full_name: Martin Dres

given: Martin

family: Sonneville

full_name: Romain Sonneville

given: Romain

family: Lafourcade

full_name: Alexandre Lafourcade

given: Alexandre

family: Navarro

full_name: Vincent Navarro

given: Vincent

family: Robert

full_name: Hélène Robert

given: Hélène

family: Azouvi

full_name: Philippe Azouvi

given: Philippe

family: Sharshar

full_name: Tarek Sharshar

given: Tarek

family: Bayen

full_name: Eleonore Bayen

given: Eleonore

family: Luyt

full_name: Charles-Edouard Luyt

given: Charles-Edouard

family: Hékimian

full_name: Guillaume Hékimian

given: Guillaume

family: Bréchot

full_name: Nicolas Bréchot

family: Schmidt

full_name: Mathieu Schmidt

family: Combes

full_name: Alain Combes

family: Demoule

full_name: Alexandre Demoule

family: Mayaux

full_name: Julien Mayaux

given: Julien


title: Benefit of an Individual Protection Against Noise and Light on Sleep Quality in ICU Patients

acronym: EARS

summary:
Sleep architecture is deeply altered in intensive care unit (ICU patients). Among factors involved in poor sleep quality are environmental factors, such as light and noise, which are an unavoidable consequence of cares.

The aim of the study is to evaluate the benefit of earplug and sleep mask on sleep architecture and quality in ICU patients.

ReferenceCitation: Demoule A, Carreira S, Lavault S, Pallanca O, Morawiec E, Mayaux J, Arnulf I, Similowski T. Impact of earplugs and eye mask on sleep in critically ill patients: a prospective randomized study. Crit Care. 2017 Nov 21;21(1):284. doi: 10.1186/s13054-017-1865-0.

family: Carreira

full_name: Serge Carreira

given: Serge

family: Lavault

full_name: Sophie Lavault

given: Sophie

family: Pallanca

full_name: Olivier Pallanca

given: Olivier

family: Morawiec

full_name: Elise Morawiec

given: Elise

family: Arnulf

full_name: Isabelle Arnulf

given: Isabelle

family: Similowski

full_name: Thomas Similowski

given: Thomas

journal_name: Critical Care

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

location_facility: Intensive Care Unit and Respiratory division ; Groupe hospitalier Pitie-Salpetriere and Universite Pierre et Marie Curie Paris 6


title: Study of the Influence of Erickson's Hypnosis and Self-hypnosis Practice on Food Impulsivity and Weight Loss in Obese Patients: a Pilot Project

acronym: HYPNODIET

summary:
High food impulsiveness, impaired food reward and stress response are involved in the phenomena of weight gain and resistance at weight loss. Henceforth, hypnosis is a complementary medicine which is recognized as effective for defined indications. Complexity and diversity of methodological studies with hypnosis does not allow to conclude on its efficacy in treating this disease.

In obese subjects with high food impulsiveness, it is expected that Erickson's hypnosis and self-hypnosis practice would improve food disinhibition assessed by an adapted questionary (TFEQ 51).


title: Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients

acronym: SOCOG-MS

summary: In recent years, studies have brought knowledge of the difficulties of social cognition in Multiple Sclerosis (MS). The brain tissue alteration at the origin of these difficulties in social cognition mechanisms remain poorly understood. Although recent behavioral studies indicated social disturbances in many of these patients, functional studies investigating specific theory of mind in MS are lacking. The use of new techniques for morphological and functional Magnetic Resonance Imaging (MRI) can identify brain activation networks, mapping the achievement and tissue integrity may be related to disorders of social cognition and cognitive. The investigators propose to study social cognition in MS patients using morphological and functional imaging to determine the mechanisms underlying phenomena such as cerebral compensation and its relationship with cognitive impairment.

lead_sponsor: University Hospital, Bordeaux


title: Auriculotherapy for Prevention of Postoperative Urinary Retention in Men Receiving Postoperative Epidural Analgesia After Thoracic Surgery

acronym: RUPO

summary: Urinary retention is a common complication of epidural analgesia. Auriculotherapy could prevent this complication. This study will be performed among men receiving thoracic epidural analgesia after thoracic surgery.

ReferenceCitation: Michel-Cherqui M, Szekely B, Lemoyne F, Feliot E, Gayat E, Fischler M. Auriculotherapy in the prevention of postoperative urinary retention in patients with thoracotomy and thoracic epidural analgesia: A randomized, double-blinded trial. Medicine (Baltimore). 2019 Jun;98(23):e15958. doi: 10.1097/MD.0000000000015958.

family: Michel-Cherqui

full_name: Mireille Michel-Cherqui

given: Mireille

family: Szekely

full_name: Barbara Szekely

given: Barbara

family: Lemoyne

full_name: François Lemoyne

given: François

family: Feliot

full_name: Elodie Feliot

given: Elodie

family: Gayat

full_name: Etienne Gayat

given: Etienne

family: Fischler

full_name: Marc Fischler

given: Marc

journal_name: Medicine

license: cc-by-nc

license_normalized: cc-by-nc

lead_sponsor: Hopital Foch


title: Acid Base Balance of ICU Patients With Severe Hypoalbuminemia, Before and After an Albumin Infusion, Using Stewart Approach

acronym: STEWALB

summary: The primary purpose was to describe the acid base balance of ICU patients with severe hypoalbuminemia using Stewart's approach for acid base disorders, before and after an human albumin perfusion.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Long-Term Effect of LIAM (Lung Insufflation Assist Maneuver) on Respiratory Performance in Non-invasive Ventilated Patients Suffering From Neuromuscular Disease

acronym: LIAM

summary: The long-term effect of LIAM (Lung Insufflation Assist Maneuver) on respiratory performance in home non-invasively ventilated (NIV) patients suffering from neuromuscular disease will be assessed in a prospective, randomized, cross over, open label study

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

location_facility: Home ventilation Unit , Raymond Poincaré hospital


title: SafEE : Safe & Easy Environment at Home for Patients Presenting a Frail Syndrome

acronym: SafEE

summary:
All over the world the increasing prevalence of chronic disorders and its impact on functional decline is challenging the sustainability of health care systems. Older individuals also frequently experience the reversible "frailty syndrome", which overlaps with chronic diseases, increasing incidence of disability.

Building a global system aiming to take in charge all causes leading to loss of autonomy is a rather complicated task involving numerous Information and Communication technologies (ICT) solutions which are not always easy to use in everyday life.

The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality of life of older people at risk.

The SafEE project develop non pharmacological therapeutic through diferent ICT (stimulation aromatherapy automatic fragrance, training interface based on Kinect sensor...) .

The goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.


title: Xylo-oligosaccharide (XOS) in Combination With Inulin Modulates Both the Intestinal Environment and Immune Status in Healthy Subjects, While XOS Alone Only Shows Prebiotic Properties

acronym: PIB

summary: The purpose of the present study was to establish the prebiotic effect of a new xylo-oligosaccharides (XOS) and of an inulin-and-XOS mixture (INU-XOS) and to determine their effect on endotoxaemia (lipopolysaccharides (LPS)) and immune parameters. In this randomized, parallel, placebo-controlled, double-blind study, sixty healthy volunteers were randomly assigned to three groups, receiving either 5 g XOS, INU-XOS (3 g inulin +1 g XOS) or an equivalent weight of wheat maltodextrins (placebo) during 4 weeks.

lead_sponsor: Institut Pasteur de Lille


title: Craniosynostosis: How to Improve the Diagnosis and Assist Patients and Their Families?

acronym: AmAc

summary:
The purposes of this study are:

to better understand the experience of the announcement for the diagnostic of craniosynostosis to patients and their families to improve the understanding of it and it modes of appropriation
to compare the announcement process concerning "simple" and "complex" forms.
to identify the intra-family issues at the announcement of a genetic mutation.
to reconstruct the care course of patients by analyzing the time of the announcement and the post-operative period.

location_facility: Centre de référence des dysostoses craniofaciales, Hôpital Necker Enfants Malades