type: Other Grant/Funding Number

title: Evaluation of Tolerance, Suckling and Food Intake After Repeated Nasals Administrations of Oxytocin in PWS Infants

summary: The Prader-Willi syndrome (PWS) includes severe neonatal hypotonia with impaired suckling leading to failure to thrive in the most severe cases, subsequently followed by an early onset of morbid obesity with hyperphagia and deficit of satiety, combined with other endocrine dysfunction probably due to hypothalamic dysfunction. The pathophysiological mechanism of the occurrence of the 2 main nutritional phases of PWS is unknown. Swaab reported a deficit in the oxytocin (OT)-producing neurons of the paraventricular nucleus in the brain of these patients. In addition of its well-known anorexigenic effect, OT is involved in establishing and maintaining social codes. Moreover in a PWS mouse model generated from a MAGEL2 KO gene a single OT injection at 5 hr of life prevent the early death observed in 50 % of the new born mice by recovering normal suckling. Interestingly this effect is no longer observed if OT injection takes place later. Our hypothesis is that early administration of OT in babies with PWS may improve suckling and possibly infant-mother interactions. In our recent study (manuscript in preparation), we have shown that a single intranasal administration of OT is well tolerated. This escalating dose study is designed to evaluate the tolerance of repeated intranasal administration of OT in 3 steps (4IU every other day, 4 IU daily, 4IU twice daily) in babies younger than 5 months with PWS.

ReferenceCitation: Tauber M, Boulanouar K, Diene G, Çabal-Berthoumieu S, Ehlinger V, Fichaux-Bourin P, Molinas C, Faye S, Valette M, Pourrinet J, Cessans C, Viaux-Sauvelon S, Bascoul C, Guedeney A, Delhanty P, Geenen V, Martens H, Muscatelli F, Cohen D, Consoli A, Payoux P, Arnaud C, Salles JP. The Use of Oxytocin to Improve Feeding and Social Skills in Infants With Prader-Willi Syndrome. Pediatrics. 2017 Feb;139(2). pii: e20162976. doi: 10.1542/peds.2016-2976.

family: Tauber

full_name: Maïthé Tauber

given: Maïthé

family: Boulanouar

full_name: Kader Boulanouar

given: Kader

family: Diene

full_name: Gwenaelle Diene

given: Gwenaelle

family: Çabal-Berthoumieu

full_name: Sophie Çabal-Berthoumieu

given: Sophie

family: Ehlinger

full_name: Virginie Ehlinger

given: Virginie

family: Fichaux-Bourin

full_name: Pascale Fichaux-Bourin

given: Pascale

family: Molinas

full_name: Catherine Molinas

given: Catherine

family: Faye

full_name: Sandy Faye

given: Sandy

family: Valette

full_name: Marion Valette

given: Marion

family: Pourrinet

full_name: Jeanne Pourrinet

given: Jeanne

family: Cessans

full_name: Catie Cessans

given: Catie

family: Viaux-Sauvelon

full_name: Sylvie Viaux-Sauvelon

given: Sylvie

family: Bascoul

full_name: Céline Bascoul

given: Céline

family: Guedeney

full_name: Antoine Guedeney

given: Antoine

family: Delhanty

full_name: Patric Delhanty

given: Patric

family: Geenen

full_name: Vincent Geenen

given: Vincent

family: Martens

full_name: Henri Martens

given: Henri

family: Muscatelli

full_name: Françoise Muscatelli

given: Françoise

family: Cohen

full_name: David Cohen

given: David

family: Consoli

full_name: Angèle Consoli

given: Angèle

family: Payoux

full_name: Pierre Payoux

given: Pierre

family: Arnaud

full_name: Catherine Arnaud

family: Salles

full_name: Jean-Pierre Salles

given: Jean-Pierre

title: The Use of Oxytocin to Improve Feeding and Social Skills in Infants With Prader–Willi Syndrome

ReferenceCitation: Borie AM, Dromard Y, Guillon G, Olma A, Manning M, Muscatelli F, Desarménien MG, Jeanneteau F. Correction of vasopressin deficit in the lateral septum ameliorates social deficits of mouse autism model. J Clin Invest. 2021 Jan 19;131(2). pii: 144450. doi: 10.1172/JCI144450.

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

publisher: American Society for Clinical Investigation

location_facility: Centre de réfrence Prader-Willi, Hospital of infants


title: A Double Blind Sham Controlled Trial of tDCS for Treatment of Negative Symptoms in Patients With Schizophrenia

acronym: STICCS

summary: The aim of this study is to evaluate the therapeutic efficacy of a neuromodulation technique, tDCS (transcranial direct current stimulation) used as a complementary treatment on negative symptoms. 60 patients will be randomized into two groups (active tDCS vs sham tDCS) and will be assessed after the intervention, 1 and 3 months after.Secondary outcomes shall include neuropsychological assessment, general symptomatology, extrapyramidal symptoms and social functioning.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: University Hospital, Montpellier

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


title: Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study.

acronym: CISSD

summary: The investigators assume that cochlear implants in this indication are not only effective but also cost-effective. The investigators' experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation). A comparative cost-utility analysis between the two arms, of medical consequences measured in terms of quality of life will identify a preference for a strategy. Specific binaural hearing measurements with respect to each treatment option (abstention, CROS, bone conduction device, cochlear implant) will also be collected.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Van de Heyning P, Vermeire K, Diebl M, Nopp P, Anderson I, De Ridder D. Incapacitating unilateral tinnitus in single-sided deafness treated by cochlear implantation. Ann Otol Rhinol Laryngol. 2008 Sep;117(9):645-52.

ReferenceCitation: Plontke SK, Heider C, Koesling S, Hess S, Bieseke L, Goetze G, Rahne T. Cochlear implantation in a child with posttraumatic single-sided deafness. Eur Arch Otorhinolaryngol. 2013 May;270(5):1757-61. doi: 10.1007/s00405-013-2350-2. Epub 2013 Jan 29.

ReferenceCitation: Vermeire K, Van de Heyning P. Binaural hearing after cochlear implantation in subjects with unilateral sensorineural deafness and tinnitus. Audiol Neurootol. 2009;14(3):163-71. doi: 10.1159/000171478. Epub 2008 Nov 13.

ReferenceCitation: Punte AK, Vermeire K, Hofkens A, De Bodt M, De Ridder D, Van de Heyning P. Cochlear implantation as a durable tinnitus treatment in single-sided deafness. Cochlear Implants Int. 2011 May;12 Suppl 1:S26-9. doi: 10.1179/146701011X13001035752336.

ReferenceCitation: Lazard DS, Marozeau J, McDermott HJ. The sound sensation of apical electric stimulation in cochlear implant recipients with contralateral residual hearing. PLoS One. 2012;7(6):e38687. doi: 10.1371/journal.pone.0038687. Epub 2012 Jun 19.

ReferenceCitation: Persson P, Harder H, Arlinger S, Magnuson B. Speech recognition in background noise: monaural versus binaural listening conditions in normal-hearing patients. Otol Neurotol. 2001 Sep;22(5):625-30.

ReferenceCitation: Bess FH. The minimally hearing-impaired child. Ear Hear. 1985 Jan-Feb;6(1):43-7.

ReferenceCitation: Bovo R, Martini A, Agnoletto M, Beghi A, Carmignoto D, Milani M, Zangaglia AM. Auditory and academic performance of children with unilateral hearing loss. Scand Audiol Suppl. 1988;30:71-4.

ReferenceCitation: Lieu JE. Speech-language and educational consequences of unilateral hearing loss in children. Arch Otolaryngol Head Neck Surg. 2004 May;130(5):524-30. Review.

ReferenceCitation: Giolas TG, Wark DJ. Communication problems associated with unilateral hearing loss. J Speech Hear Disord. 1967 Nov;32(4):336-43.

ReferenceCitation: Dalzell L, Orlando M, MacDonald M, Berg A, Bradley M, Cacace A, Campbell D, DeCristofaro J, Gravel J, Greenberg E, Gross S, Pinheiro J, Regan J, Spivak L, Stevens F, Prieve B. The New York State universal newborn hearing screening demonstration project: ages of hearing loss identification, hearing aid fitting, and enrollment in early intervention. Ear Hear. 2000 Apr;21(2):118-30.

ReferenceCitation: Chapman DA, Stampfel CC, Bodurtha JN, Dodson KM, Pandya A, Lynch KB, Kirby RS. Impact of co-occurring birth defects on the timing of newborn hearing screening and diagnosis. Am J Audiol. 2011 Dec;20(2):132-9. doi: 10.1044/1059-0889(2011/10-0049). Epub 2011 Sep 22.

ReferenceCitation: Byl FM Jr. Sudden hearing loss: eight years' experience and suggested prognostic table. Laryngoscope. 1984 May;94(5 Pt 1):647-61. Review.

ReferenceCitation: Arndt S, Aschendorff A, Laszig R, Beck R, Schild C, Kroeger S, Ihorst G, Wesarg T. Comparison of pseudobinaural hearing to real binaural hearing rehabilitation after cochlear implantation in patients with unilateral deafness and tinnitus. Otol Neurotol. 2011 Jan;32(1):39-47. doi: 10.1097/MAO.0b013e3181fcf271.

ReferenceCitation: Firszt JB, Holden LK, Reeder RM, Waltzman SB, Arndt S. Auditory abilities after cochlear implantation in adults with unilateral deafness: a pilot study. Otol Neurotol. 2012 Oct;33(8):1339-46. doi: 10.1097/MAO.0b013e318268d52d.

ReferenceCitation: Hassepass F, Aschendorff A, Wesarg T, Kröger S, Laszig R, Beck RL, Schild C, Arndt S. Unilateral deafness in children: audiologic and subjective assessment of hearing ability after cochlear implantation. Otol Neurotol. 2013 Jan;34(1):53-60. doi: 10.1097/MAO.0b013e31827850f0.

ReferenceCitation: Bishop CE, Eby TL. The current status of audiologic rehabilitation for profound unilateral sensorineural hearing loss. Laryngoscope. 2010 Mar;120(3):552-6. doi: 10.1002/lary.20735. Review.

ReferenceCitation: Essink-Bot ML, Stouthard ME, Bonsel GJ. Generalizability of valuations on health states collected with the EuroQolc-questionnaire. Health Econ. 1993 Oct;2(3):237-46.

ReferenceCitation: Chevalier J, de Pouvourville G. Valuing EQ-5D using time trade-off in France. Eur J Health Econ. 2013 Feb;14(1):57-66. doi: 10.1007/s10198-011-0351-x. Epub 2011 Sep 21.

family: Chevalier

full_name: Julie Chevalier

given: Julie

sequence: first

family: de Pouvourville

full_name: Gérard de Pouvourville

given: Gérard

sequence: additional

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The European Journal of Health Economics

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Valuing EQ-5D using Time Trade-Off in France

ReferenceCitation: Gaylor JM, Raman G, Chung M, Lee J, Rao M, Lau J, Poe DS. Cochlear implantation in adults: a systematic review and meta-analysis. JAMA Otolaryngol Head Neck Surg. 2013 Mar;139(3):265-72. doi: 10.1001/jamaoto.2013.1744. Review.

ReferenceCitation: Drummond M, O' brien B, Stodart G et al. 1998. Méthodes d'évaluation économique des programmes de santé. Paris : Economica, 1998.

ReferenceType: result

ReferenceCitation: Marx M, Costa N, Lepage B, Taoui S, Molinier L, Deguine O, Fraysse B. Cochlear implantation as a treatment for single-sided deafness and asymmetric hearing loss: a randomized controlled evaluation of cost-utility. BMC Ear Nose Throat Disord. 2019 Feb 4;19:1. doi: 10.1186/s12901-019-0066-7. eCollection 2019.

family: Marx

full_name: Mathieu Marx

given: Mathieu

family: Costa

full_name: Nadège Costa

given: Nadège

family: Lepage

full_name: Benoit Lepage

given: Benoit

family: Taoui

full_name: Soumia Taoui

given: Soumia

family: Molinier

full_name: Laurent Molinier

given: Laurent

family: Deguine

full_name: Olivier Deguine

given: Olivier

family: Fraysse

full_name: Bernard Fraysse

given: Bernard

journal_name: BMC Ear, Nose and Throat Disorders

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

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

ReferenceCitation: Dorbeau C, Galvin J, Fu QJ, Legris E, Marx M, Bakhos D. Binaural Perception in Single-Sided Deaf Cochlear Implant Users with Unrestricted or Restricted Acoustic Hearing in the Non-Implanted Ear. Audiol Neurootol. 2018;23(3):187-197. doi: 10.1159/000490879. Epub 2018 Oct 23.

location_facility: University Hospital of Toulouse - Pierre Paul Riquet Hospital


title: Prospective, Open Label, Randomized Study Comparing Bipolar Radiofrequency Potentiated by Infrared Light to Doxycycline in Patient With Papulopustular Rosacea

acronym: Rosac-RF

summary: Rosacea is a chronic facial disfiguring dermatosis characterized by different stages like flushing, erythema, telangiectasia and papulo-pustular lesions. Recommended treatments include topical (metronidazole) and systemic (doxycycline) antibiotics with only a suspensive effect. The bipolar radiofrequency (RF) with Elos system (infrared light) is a device emitting an electromagnetic current inducing an increase in temperature when applied on the skin, potentiated by infrared light. The monopolar RF has already been used in rosacea on a small number of cases with positive and prolonged results. RF with Elos system has been evaluated on erythemato-telangiectasic rosacea with encouraging results. Demodex folliculorum (DF) is a long transparent mite which asymptomatically parasitizes pilosebaceous follicle of normal human skin sometimes responsible of inflammatory facial dermatoses. The prevalence and density of DF are increased in rosacea, and DF is suspected to play a role in the pathogenesis of rosacea. DF is sensitive to heat, and the investigators hypothesize that radiofrequency treatment may affect the survival of the mite and should be effective to treat papulopustular rosacea.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: CRC, Hôpital de l'Archet, 151 route de saint-ginestière


title: Effect on Relationship of a Brief Preventive Program: Pragmatic Pilot Randomized Controlled Trial." - Supportive Program for Mother With BPD

acronym: PAM-B

summary:
Borderline Personality Disorder (BPD) is characterized by a pervasive pattern of instability of interpersonal relationships, self-image and emotions as well as marked impulsivity. When patients have children, they are at high risk of severe emotional and relational disturbances (withdrawal, low self-esteem, depression, suicidal thoughts). In addition, studies support the effectiveness of parental guidance group to reduce emotional and behavioral difficulties of children. To our knowledge there are no programs directed to mothers with BPD who received a controlled evaluation.

From experience with parental guidance, data from the observation of children of patients with BPD and psychosocial programs directed to patients BPD, we have built for preventive intervention. The Supportive Program for Mothers with BPD (SuPMother-B) consists of 10 group sessions providing information (education, childcare, care specific to BPD) and promotes mother-child interactions (observation, games).

Purpose: Compare the effect of a program (SuPMother-B) group, of 10 sessions, offered to mothers with a BPD in addition to a minimal intervention (diagnostic announcement and provision of health care resources) on behavior withdrawal of children at 6 months compared to a group of mothers receiving only minimal intervention.

Primary outcome: Difference at 6 months between the experimental and control groups on scores on the assessment scale withdrawal (Alarm Distress Baby (ADBB)).

primary_purpose: Prevention

lead_sponsor: University Hospital, Toulouse

location_facility: Service de psychiatrie de l'enfant et de l'adolescent - Hôpital La Grave - centre Hospitalier de Toulouse

intervention_type: Other

status_simplified: Completed


title: Constitution of an Open Monocentric Cohort of HIV Infected Patients

acronym: OVIHD

summary: The purpose of this study is to improve our knowledge concerning HIV infection, treated or not, in the current conditions of care to optimize it.

status: Recruiting

primary_purpose: Other

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Biological

status_simplified: Ongoing


type: Other Identifier

title: Comparison of Two Rehabilitation Strategies in Patients With Hemiparesis One Year or More After Stroke. Efficacy and Cost After One Year Treatment. A Randomized, Controlled, Multicenter, Single Blind Study

acronym: NEURORESTORE

summary:
In the situation of motor limitations that people often experience after stroke, current health systems cannot provide for the daily amount and duration of high intensity muscle stretch and motor training that would be required over protracted periods to involve muscle and brain plasticity. For patients with sufficient cognitive abilities, Guided Self-rehabilitation Contracts allow implementing stretch and training at high intensity and may result in meaningful functional improvement in chronic stages, as long as discipline persists over at least a year span.

This single blind control protocol will evaluate Guided Self-rehabilitation Contracts as against conventional therapy in the community, for a one year duration in persons with chronic hemiparesis after stroke.

ReferenceType: derived

ReferenceCitation: Gracies JM, Pradines M, Ghédira M, Loche CM, Mardale V, Hennegrave C, Gault-Colas C, Audureau E, Hutin E, Baude M, Bayle N; Neurorestore Study Group. Guided Self-rehabilitation Contract vs conventional therapy in chronic stroke-induced hemiparesis: NEURORESTORE, a multicenter randomized controlled trial. BMC Neurol. 2019 Mar 12;19(1):39. doi: 10.1186/s12883-019-1257-y.

family: Gracies

full_name: Jean-Michel Gracies

given: Jean-Michel

family: Pradines

full_name: Maud Pradines

given: Maud

family: Ghédira

full_name: Mouna Ghédira

given: Mouna

family: Loche

full_name: Catherine-Marie Loche

given: Catherine-Marie

family: Mardale

full_name: Valentina Mardale

given: Valentina

family: Hennegrave

full_name: Catherine Hennegrave

given: Catherine

family: Gault-Colas

full_name: Caroline Gault-Colas

given: Caroline

family: Audureau

full_name: Etienne Audureau

given: Etienne

family: Hutin

full_name: Emilie Hutin

given: Emilie

family: Baude

full_name: Marjolaine Baude

given: Marjolaine

family: Bayle

full_name: Nicolas Bayle

given: Nicolas

currency_apc_doaj: GBP

journal_name: BMC Neurology

oa_colors: green gold

evidence: oa journal (via doaj)

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature


title: Evaluation of Cardiac Steatosis in Cushing's Syndrome. A 1H-Magnetic Resonance Spectroscopy Study

acronym: CORTICOEUR

summary: This study aims at evaluating the myocardial triglyceride content and cardiac structure and function, using 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging, in patients with Cushing's syndrome before and after treatment and in age-, sex- and BMI-matched healthy volunteers. The investigators make the hypothesis that Cushing's syndrome patients compared to healthy subjects present with excess lipid storage in cardiac myocytes, reversible upon correction of hypercortisolism.

design_allocation: Non-Randomized

primary_purpose: Diagnostic


title: Evaluation of Richmond Agitation Sedation Scale According to Alveolar Concentration of Sevoflurane During a Sedation With Sevoflurane in ICU Patients

acronym: SEVORASS

summary: Describe the Richmond Agitation Sedation Scale (RASS) values corresponding to the values of Minimum alveolar concentration of sevoflurane during sedation of patients in ICU

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Drug


title: An Open Label Multicenter, Phase I-II Study With Tumor Molecular Pharmacodynamic (MPD) Evaluation and Pharmacokinetics of PD-0332991 in Patients Suffering Metastatic Melanoma With BRAFv600 Mutated and CDKN2A Loss and Expression of Rb and Treated by Vemurafenib

acronym: OPTIMUM

summary:
An open label multicentre, phase I-II study with tumour molecular pharmacodynamics (MPD) evaluation and pharmacokinetics of PD-0332991 added to vemurafenib in patients suffering metastatic melanoma with BR.

The main objective is to establish the Maximum Tolerated Dose (MTD) of PD-0332991 when added to standard vemurafenib therapy (960 mg BID). The estimated MTD is defined as the dose of PD-0332991 combined with vemurafenib that will be associated with a prespecified proportion of patients experiencing a Dose-Limiting Toxicity (DLT), ie, 1/3.


summary:
This study is complementary to the main study "Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months After Alcohol Withdrawal " NCT01491347.

Liver stiffness variation is one of the major somatic effect of chronic alcohol consumption. It is a consequence of numerous mechanisms, including inflammation. Liver stiffness seems to depend on alcohol consumption in alcohol dependent patient, more precisely on the time after the last alcohol consumption. This is very few documented after alcohol withdrawal, and has never been explored during several months after withdrawal as a function of alcohol consumption and abstinence.

Brain Derived neurotrophic Factor (BDNF) seems to play a major role in general homeostasis and also liver function.

We propose here to analyse the serum BDNF levels variations after withdrawal according to liver stiffness levels and alcohol consumption status.

We will also measure liver stiffness using Fibroscan® in alcohol dependent subjects included in the main study to search for a link with serum BDNF levels and abstinence at day 0, 14, 28 and months 2, 4, and 6.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Esquirol


title: Galvanic Vestibular Stimulation : Role in the Improvement of Egocentric Frame in Patient With Right Parietal Lobe Lesions

acronym: GVS

summary: Right posterior parietal cortex is involved in spatial cognition. Blindfolded patients suffering right posterior parietal lesions fail to update their own position after a body rotation. Right cathodal galvanic vestibular stimulation activates right posterior parietal cortex and reduces symptoms of spatial neglect, another disability frequently encountered after right posterior parietal lesion. The aims of this study are to confirm posterior parietal involvement in automatic updating of body-centered spatial relationships and to evaluate therapeutic effects of galvanic vestibular stimulation. Performances of three groups of adults are compared before and during galvanic vestibular stimulation on a pointing task: a healthy control group, a brain-injured control group with stroke lesions sparing right posterior parietal cortex and a group of stroke patients with right posterior parietal lesions.

status: Terminated

primary_purpose: Supportive Care

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

lead_sponsor_type: industriel


title: Assessment of the Effectiveness of Hysteroscopy in the Treatment of Intrauterine Trophoblastic Retentions

acronym: HY-PER

summary: The purpose of this study of is to compare subsequent fertility rates between hysteroscopy and aspirative curettage in the surgical treatment of incomplete spontaneous abortion

ReferenceCitation: Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tunçalp Ö, Lavelanet A, Gülmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6:CD012602. doi: 10.1002/14651858.CD012602.pub2.

name: Tommy’s National Centre for Miscarriage Research, Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women’s Health Research; University of Birmingham; Birmingham UK

family: Ghosh

full_name: Jay Ghosh

given: Jay

family: Papadopoulou

full_name: Argyro Papadopoulou

given: Argyro

family: Devall

full_name: Adam J Devall

given: Adam J

family: Jeffery

full_name: Hannah C Jeffery

given: Hannah C

name: Institute of Applied Health Research, College of Medical and Dental Sciences; University of Birmingham; Birmingham UK

family: Beeson

full_name: Leanne E Beeson

given: Leanne E

family: Do

full_name: Vivian Do

given: Vivian

name: Test Evaluation Research Group, Institute of Applied Health Research; University of Birmingham; Birmingham UK

family: Price

full_name: Malcolm J Price

given: Malcolm J

family: Tobias

full_name: Aurelio Tobias

given: Aurelio

name: UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Sexual and Reproductive Health and Research; World Health Organization; Geneva Switzerland

family: Tunçalp

full_name: Özge Tunçalp

given: Özge

family: Lavelanet

full_name: Antonella Lavelanet

given: Antonella

family: Gülmezoglu

full_name: Ahmet Metin Gülmezoglu

given: Ahmet Metin

family: Coomarasamy

full_name: Arri Coomarasamy

given: Arri

family: Gallos

full_name: Ioannis D Gallos

given: Ioannis D

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

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

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Huchon C, Koskas M, Agostini A, Akladios C, Alouini S, Bauville E, Bourdel N, Fernandez H, Fritel X, Graesslin O, Legendre G, Lucot JP, Matheron I, Panel P, Raiffort C, Fauconnier A. Operative hysteroscopy versus vacuum aspiration for incomplete spontaneous abortion (HY-PER): study protocol for a randomized controlled trial. Trials. 2015 Aug 19;16:363. doi: 10.1186/s13063-015-0900-1.

family: Huchon

full_name: Cyrille Huchon

given: Cyrille

family: Koskas

full_name: Martin Koskas

given: Martin

family: Agostini

full_name: Aubert Agostini

given: Aubert

family: Akladios

full_name: Cherif Akladios

given: Cherif

family: Alouini

full_name: Souhail Alouini

given: Souhail

location_facility: Centre hospitalier intercommunal de poissy-saint germain en Laye


title: Randomised Trial Comparing 12 Months of Cyclic Enteral Nutrition to Supplementary Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease

acronym: CD-HOPE

summary: The purpose of this study is to compare the rate of first relapse at 12 months between maintenance therapy with cyclic exclusive enteral nutrition (EEN) (at least 100% daily calories) and maintenance therapy with supplementary enteral nutritional support (25% daily calories).

ipd_sharing: No

intervention_type: Dietary Supplement


title: Treatment of Chronic Active Antibody-mediated Rejection With Bortezomib in Kidney Transplantation

acronym: TRIBUTE

summary: The purpose of the study is to assess the efficacy of bortezomib, in association with steroids, plasma exchange, and polyclonal intravenous immunoglobulins, in the treatment of chronic antibody mediated rejection due to donor specific anti-HLA antibodies, in kidney transplant recipients


title: Non-invasive Diagnosis of Chronic Kidney Disease in Renal Transplants Kidney Transplanted Using Ultrasound Functional Imaging

acronym: Imag-NCT

summary: The hypothesis of our study is that a correlation exists between the couple ultrasound elastography- renal perfusion estimated with contrast-enhanced ultrasound and the degree of fibrosis estimated in a semi-quantitative way in 4 stages (0; 25 %; 25-50 %; > 50 %), as elastography alone did not allow to differentiate moderated fibrosis at 3 months in our feasibility study.

primary_purpose: Screening


title: Randomized Multicenter Phase III Study Comparing the Rate of Molecular Response 4.5 at 12 Months in Newly Diagnosed Philadelphia Positive Chronic Phase Chronic Myelogenous Leukemia Patients Receiving Either Frontline Nilotinib 600 mg Daily or Nilotinib 600 mg Daily Combined to Pegylated Interferon-alfa 2a (Peg-IFN)

acronym: PETALs

summary: This is a phase III trial comparing, for newly diagnosed chronic phase CML patients, nilotinib 600 mg BID as a standard arm and nilotinib 600 mg BID combined to interferon alfa 2 a (pegylated form improving tolerance and maybe enhancing is efficacy) at increased doses for a total of 24 months of combination, in a 1:1 randomized manner. The assessment for the primary efficacy endpoint will be performed at 12 months (since nilotinib initiation) and is the rate patients obtaining MR4.5 will be measured at this time point.

lead_sponsor: Hospices Civils de Lyon


title: SEVOflurane Inhalation in CARdiac Arrest Resuscitated Patients Treated With Therapeutic Hypothermia

acronym: SEVOCAR

summary: Studying the feasibility of an initial sedation with inhalated sevoflurane during therapeutic hypothermia of cardiac arrests resuscitated patients.


title: Safety and Effectiveness Evaluation of the Minimal Invasive Deformity Correction (MID-C) System in Adolescent Idiopathic Scoliosis (AIS)

acronym: MID-C

summary:
Adolescent idiopathic scoliosis (AIS) is a common disorder of unknown etiology in which the vertebrae and discs gradually develop a curvature that is first detected in patients between 11 and 20 years of age. The deformity is 3-dimensional, with a coronal curve measured from radiographs by the Cobb angle .

The Cobb angle measurement of scoliosis represents the sum of the angular wedging of each vertebra and disc between the superior and inferior end vertebrae . Although a small curve is well tolerated and does not require treatment, a large curve can progress to the point that it is cosmetically unacceptable, interferes with chest wall mechanics, and produces cardiac and pulmonary compromises. The natural history of AIS apparently includes 2 stages: the initiation of the curve and its subsequent progression. The factors responsible for the initiation of the curve are unknown, but the subsequent progression of the curve is clearly associated with the adolescent growth spurt . The primary risk factors for progression include age at onset and the magnitude of the curve; young patients with large curves are at the highest risk .

Although numerous treatment methods have been recommended for patients with AIS, the only accepted treatment includes bracing for skeletally immature patients with curves between 25 and 40 degrees and operative correction with spinal fusion for patients with curves greater than 45 degrees. For many teenagers, the cosmetic and social concerns associated with bracing has caused compliance problems with wearing the brace and many patients only wear the brace at home . While operative intervention completely corrects the scoliosis or rib hump, it eliminates segmental spinal motion, and concentrates stresses at the ends of the fusion potentially leading to disc degeneration and back pain.

Despite satisfactory short-term results of operative instrumentation and fusion, a less invasive technique preserving more motion with a smaller scar represents a major improvement. Realizing this goal is contingent on treating curves early, before they progress to an irreversible deformity, and when there is still enough residual growth and remodeling potential.

ApiFix Ltd has developed a novel implant for less invasive treatment of AIS. The MID-C system is designed to correct the deformity step by step along a period of time, giving the skeletal and soft tissues time to accommodate any incremental correction.

The MID-C System inherent benefits are:

Only two screws are used
Incision size is much smaller
Simpler operation with shorter operative time
Less complications (attributed to the three points above).
Minimal spinal mobility loss.

All the device components are made of materials well accepted in the orthopedic field and are fully biocompatible (see Investigator Brochure).

The unique concept of the system and the materials used may provide favorable results as follows: Smaller scare, quicker healing period and better spine mobility over the years.

This study is designed to demonstrate that the MID-C System is safe and effective.

lead_sponsor: Apifix

location_facility: Unité d'Orthopédie-traumatologie, Rachis II


title: Predictive Factors of Failure or Success of Sedation With Dexmedetomidine in ICU

summary: Research predictive factors of success or failure of a sedation with Dexmedetomidine in ICU


type: Registry Identifier

title: ANC2 Pilot Study Study of the Relationship Between Clinical and Paraclinical Markers During Situations of Cachexia and Pre-cachexia in Patients Over 70 Years With Colorectal Surgery

summary:
Cachexia associated with cancer is a grave and most of the time irreversible common situation. It seems independent from the size of the tumor or from its metastatic character. The consequences for the management of the patient are major and exceed widely the frame of the nutrition.

Undernutrition of patients with cancer is described by a decrease of the energy contributions and a loss of muscular and fat mass, leading to a progressive functional deficiency which can go to the cachectic state.

Actually, clinical criteria are proposed allowing to characterize the state of pre-cachexia but it remain too indistinct to allow an early and efficient screening and set up effective measures of prevention of the cachexia, to avoid the loss of muscular tissue and the cast iron of the energy reserves.

It is necessary to have clinical and biological markers with diagnostic aim and forecasts during the situations precedents the appearance of cachexia.

The present study will allow calibrating a longitudinal study, which could confirm the value of measures made for the diagnosis of pre-cachexia.

location_facility: Groupement Hospitalier Sud - Service de Médecine Gériatrique


title: Impact of General Anesthesia on Enterocyte Damage

acronym: GUT

summary: During non urgent surgery, general anesthesia might induce enterocyte damage. I-FABP is a performant biomarker of enterocyte damage. We aimed to study whether patient ongoing general anesthesia for non-urgent surgery have an elevation of plasma I-FABP concentration.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: FREEDOM: "Pilot Study of the Feasibility and Safety of Resuming Early Walking After Manual Compression in Patients Treated for Peripheral Artery Disease by Endovascular Technique Involving Retrograde Femoral Puncture"

acronym: FREEDOM

summary:
Over the past years, arterial closure systems have tended to replace manual compression to ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce hemostasis and patient immobilization times, thus enabling early resumption of walking. These devices have contributed extensively to the development of outpatient stays for cardiology, vascular and neuro-radiology procedures.

According to certain studies however, it would appear that arterial closure devices do not present any greater benefits than manual compression in terms of hemostasis and complications. Moreover, the use of increasingly small diameter instruments would tend to render manual compression sufficient. Finally, the use of these devices generates additional costs.

The purpose of our study is to evaluate the feasibility and safety of manual compression before early resumption of walking in patients managed by conventional hospitalization for a diagnostic or therapeutic endovascular procedures by retrograde femoral puncture with 5F guide catheter.

lead_sponsor: Nantes University Hospital


title: Pilot Study of Sedation With Propofol in Refractory Pains Due to Care in Palliative Care Unit

summary:
In the palliative care unit, certain patients suffer from pain associated with medical procedures/care which is poorly controlled by antalgics. These situations may necessitate temporary sedation to improve comfort and facilitate treatment. No proven consensus exists, either in the literature or in clinical studies conducted, on the choice of sedative agent however Midazolam is the general recommendation.

The investigators believe that Propofol could be used in this instance


title: Evaluation of Grip Strength With Digitized Sensor in Adults With Rheumatoid Arthritis

summary:
Rheumatoid arthritis (RA) is the most common chronic inflammatory arthritis in adults. Monitoring of disease activity is based on Disease Activity Score 28 (DAS 28). There are also validated questionnaires for self-assessment of the disease by the patient. Grip strength measured using a digitized sensor used by the patient could be an additional tool to the remote monitoring of patients with RA.

Main Objective : To evaluate the correlation between the measurement of grip strength in the dominant hand measured by a digital sensor and activity of RA assessed by DAS 28

Secondary objective : Evaluate the correlation between grip strength of the dominant hand and :

scores of fatigue and pain (VAS and FACIT)
the self-assessment scores known in RA : functional index Health Assessment Questionnaire (HAQ) and scores of activity RAPID3 and RADAI5.

It is a cross-sectional study involving 150 patients followed in our department for RA. Grip strength of the dominant hand will be measured by a digitalized sensor during a single visit integrating into the routine monitoring of patients.


title: Amyloïd Load in Elderly Population: Effect of Cognitive Reserve

acronym: EDUMA

summary: This research aim to explore relationships between the presence of amyloid burden and cognitive performance, and its modulation by educational level. For this purpose we will combine Positron emission tomography (PET) imaging and neuropsychological assessment acquired on 3 groups of subjects, from two population-based cohorts "3C" and "AMIMage" The first group includes cognitively intact participants who will serve as controls, the second group, subjects with mild cognitive impairments without memory complaint and the third, subjects with both mild cognitive impairments and memory complaint.

lead_sponsor: University Hospital, Bordeaux


title: Pharmacogenetic of the Salbutamol Efficacy in Asthma Crisis for Children in Emergency Department

acronym: Pegase

summary: this study is designed to identify the genetic factors which can be implicated in the salbutamol responsiveness for asthmatic children in pediatric emergency department

lead_sponsor: Hôpital Necker-Enfants Malades


title: Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation - Efficacy and Safety Results After the First Year of Treatment in the Real Life Setting.

summary: The purpose of this study is to determine whether the treatment with Ivacaftor remains effective and safe in the patients with cystic fibrosis (and at least one G551D CFTR mutation) in the real life setting, after the drug has been approved by the Health authorities.

time_perspective: Retrospective


title: Role and Interactions Between Immunoregulatory T Lymphocytes Subtypes After Allogeneic Haematopoietic Stem Cell Transplantation (HSCT): Identification of New Partners Implicated on the Development of GVT (Graft Versus Tumor) and Anti-infectious Responses Without GVHD (Graft Versus Host Disease)

acronym: REG-Allo

summary: The purpose of this study is to confirm that invariant NKT lymphocytes (iNKT) reconstitution in recipient and in the graft content can predict the outcome of human allogeneic HSCT and to set up an algorithm for clinical practice that would allow the prediction of acute GVHD risk according to the quantity and functionality

status: Active, not recruiting


title: Effects of Drinking at PACU Discharge After General Anaesthesia With Airway Control on Aspiration, Vomiting and Patients Comfort.

acronym: I-DRINC

summary:
National guidelines about post-operative fasting after general anesthesia are missing.

Current clinical practices are highly variable and no study has ever evaluated on a large scale the real risk of an early drinks recovery in postoperative period.

The aim of this study is to state the impact of early drinks recovery after general anesthesia with laryngeal mask or endotracheal intubation on the risk of aspiration.

lead_sponsor: Poitiers University Hospital

intervention_type: Procedure


title: Influence of Variations of Systemic Venous Return on Analgesia Nociception Index (ANI) During General Anaesthesia

summary: The purpose of this study is to determine whether the value of analgesia nociception index (ANI) is influenced by variations of systemic venous return (cardiac preload) under general anaesthesia.

lead_sponsor: University Hospital, Lille


title: Taking Into Account the Patient/Parent Preference in the Galenic Choice in Atopic Dermatitis. Feasibility and Impact on Treatment Adherence.

acronym: DACE

summary:
Atopic dermatitis is a chronic inflammatory skin disease often occurring in childhood.

The treatment consists in making daily local treatment with topical steroid on inflammatory lesions and emollient on the whole body. However, approximately 70% of patients do not adhere to therapy.

Studies have shown that this treatment failure is caused by the complexity of the treatment, the time required for its implementation, the cost of treatment, the dosage of the products, fear of side effects or misunderstanding about the chronicity of these diseases inflammatory conditions of the skin.

This study aims to evaluate the consideration of patient preference in the choice of excipient used for the topical treatment of eczema.


title: Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam

acronym: IPAD

summary:
Rationale:

The most frequently used means to prevent pre-anaesthetic anxiety in children is a drug premedication. Midazolam, a benzodiazepine, is mainly used. It requires time for action, so coordination between departments and operating room, exposed to the risks of side effects and failure and this variability action. Alternative means were evaluated, such as the presence of parents during anaesthetic mask induction, distraction by clowns, hypnosis or video games.

Electronic tabs are small devices; light, easy to use with age-specific and interactive programs. Our hypothesis is that these electronic tabs are more effective in reducing anxiety and distract children compare to preoperative medication.

Methods: This is a monocentric, randomized, open-label study comparing patients aged 4 to 10 years old programmed for a short term and low level of pain outpatient surgery. My pass score will be measured when arriving at the hospital, at the time of the separation with the parents, at the time of the anaesthetic mask induction and after the surgery.

118 patients will be randomized as follows :

Arm 1 : Hypnovel® (midazolam)
Arm 2 : Electronic tab The recruitment is performed by general practitioners in the Lyon area.

ReferenceCitation: Marechal C, Berthiller J, Tosetti S, Cogniat B, Desombres H, Bouvet L, Kassai B, Chassard D, de Queiroz Siqueira M. Children and parental anxiolysis in paediatric ambulatory surgery: a randomized controlled study comparing 0.3 mg kg-1 midazolam to tablet computer based interactive distraction. Br J Anaesth. 2017 Feb;118(2):247-253. doi: 10.1093/bja/aew436.

family: Marechal

full_name: C Marechal

given: C

family: Berthiller

full_name: J Berthiller

given: J

family: Tosetti

full_name: S Tosetti

given: S

family: Cogniat

full_name: B Cogniat

given: B

family: Desombres

full_name: H Desombres

given: H

family: Bouvet

full_name: L Bouvet

given: L

family: Kassai

full_name: B Kassai

family: Chassard

full_name: D Chassard

given: D

family: de Queiroz Siqueira

full_name: M de Queiroz Siqueira

given: M

journal_name: British Journal of Anaesthesia

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Children and parental anxiolysis in paediatric ambulatory surgery: a randomized controlled study comparing 0.3 mg kg −1 midazolam to tablet computer based interactive distraction

location_facility: Service d'anesthésie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon


title: Effects of 4-week Bifidobacterium-lactis HN019 Supplementation on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation: A Double-blind, Randomized, Placebo-controlled Dose-ranging Trial

summary: To determine if Bifidobacterium lactis HN109 improves transit time and gastrointestinal symptoms in adults with constipation.

lead_sponsor: Danisco Sweeteners Oy


title: Cognitive Mechanisms and Cerebral Substrate of Naming Impairment During Aging. Behavior and Neuroimaging Approaches.

acronym: SEMVIE

summary: The purpose of this study is to understand the effect of age on language abilities. The investigators aim at investigating the cerebral modifications that take place in normal aging, at the functional an anatomical level.

lead_sponsor: University Hospital, Grenoble


title: Does Irritable Bowel Syndrome Improved by Low FODMAP Diet ?

acronym: FructIBS

summary: The patients having a syndrome SII would be more intolerant in the fructose than the healthy subjects and would benefit from a fructose diet but also from the fructans which contain some fructose. The intolerance in the fructose is diagnosed thanks to a respiratory test after absorption of fructose. However, the eviction of the fructose is sometimes recommended to the patients without having realized beforehand the test of intolerance.

ReferenceCitation: Melchior C, Desprez C, Houivet E, Debeir LA, Bril L, Maccarone M, Grout E, Ducrotté P, Gourcerol G, Leroi AM. Is abnormal 25 g fructose breath test a predictor of symptomatic response to a low fructose diet in irritable bowel syndrome? Clin Nutr. 2020 Apr;39(4):1155-1160. doi: 10.1016/j.clnu.2019.04.031. Epub 2019 May 8.

family: Melchior

full_name: Chloé Melchior

given: Chloé

family: Desprez

full_name: Charlotte Desprez

given: Charlotte

family: Houivet

full_name: Estelle Houivet

given: Estelle

family: Debeir

full_name: Laura Armengol Debeir

given: Laura Armengol

family: Bril

full_name: Laura Bril

given: Laura

family: Maccarone

full_name: Mathilde Maccarone

given: Mathilde

family: Grout

full_name: Emilie Grout

given: Emilie

family: Ducrotté

full_name: Philippe Ducrotté

given: Philippe

family: Gourcerol

full_name: Guillaume Gourcerol

given: Guillaume

family: Leroi

full_name: Anne-Marie Leroi

given: Anne-Marie

journal_name: Clinical Nutrition

lead_sponsor: University Hospital, Rouen

location_facility: Service de Physiologie Digestive, Urinaire, Respiratoire et Sportive


title: Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot.

summary: Long term survival of patients with repaired tetralogy of Fallot is excellent (about 85% at 35 year-old). However these patients are exposed to residual pulmonary stenosis (PS) and/or pulmonary regurgitation (PR). It is well established that these lesions can lead to irreversible sequelae such as right ventricle dilatation and dysfunction. Pulmonary valve replacement technique was developed to avoid long term right ventricular dysfunction. Pulmonary valve replacement indications are based upon the presence of symptoms at exercise and/or morphological or functional parameters such as severe pulmonary regurgitation with right ventricle dilatation/dysfunction. The best timing of such intervention is still underdebate with the main aim of having the right balance between avoiding long term sequelae of PR or PS and being the latter possible to push ahead the need for new intervention. Recent publication showed that myocardial diffuse fibrosis can contribute to irreversible alteration of myocardial contractility. Quantification of diffuse fibrosis by magnetic resonance imaging is feasible and could help the physician to best determine the right timing for PVR in this population of patients. Cardiac function assessment at rest and during exercise is possible using MR and our centre has developed a program for cardiac exercise during MRI. This could help to detect infra clinic abnormality and to analyse myocardial adaptation during exercise.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation: Monocentric Prospective Study

acronym: DOTATATE

summary:
18F-FDOPA PET-CT is currently the gold standard in the evaluation of Pheochromocytomas and Paragangliomas (PHEO - PGL) since these tumors can also decarboxylate amino acids such as dihydroxyphenylalanine (DOPA). This property is common to tumors of the APUD system (Amine Precursor Uptake and Decarboxylation). In recent years, PET (Positron Emission Tomography) imaging using peptide receptors has gained an increasing role in the management of NETs. The use of somatostatin agonists, radiolabeled with gallium-68 (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of SSTRs-expressing tumors, including PGLs.

In the present study, the investigators have chosen DOTATATE (Nal3-octreotate) rather than other agonists (DOTATOC and DOTANOC), because of its higher affinity for SST2 which is the most overexpressed subtype in PHEO/PGL. However, performances of 18F-FDOPA PET-CT and 68Ga-DOTATATE PET-CT have never been compared in this clinical setting.


title: Effects of Levothyroxine Treatment on Hemodynamic and Isotopic Renal Functions in Subclinical Hypothyroidism

summary:
Renal and cardiovascular effects of subclinical hypothyroidism, defined by a high TSH and normal T4 are less known and the indications for treatment of subclinical hypothyroidism are subject to controversies.

The investigators propose to assess whether the hormone replacement for subclinical hypothyroidism in patients with chronic kidney disease is beneficial for hemodynamic and renal functions and which mechanisms are involved.

Isotopic measurements of glomerular filtration and renal blood flow and an hemodynamic evaluation by transthoracic echocardiography and flow-mediated vasodilation will be carried out before and 6 months after substitution.

status: Withdrawn

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Effect of High-flow Nasal Cannula Oxygen on Lung Volumes Determined by Electrical Impedance Tomography

acronym: OXIDIA

summary: Effect of High-flow nasal cannula oxygen on end-expiratory lung volumes determined by electrical impedance tomography

time_perspective: Cross-Sectional


title: Single-center, Double-blind, Placebo-controlled, Randomized, Single-ascending Dose, With Nested Cross-over for Food Effect, to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-451840 in Healthy Subjects (Part A)

summary: The primary objective of the study was to evaluate the safety and tolerability of ACT-451840 in healthy male subjects.Secondary objectives were : to investigate the pharmacokinetics (PK) of ACT-451840; to investigate the effect of food on the PK of ACT-451840; to evaluate the urinary excretion of ACT-451840 and to investigate the antimalarial activity of ACT-451840.

ReferenceCitation: Bruderer S, Hurst N, de Kanter R, Miraval T, Pfeifer T, Donazzolo Y, Dingemanse J. First-in-humans study of the safety, tolerability, and pharmacokinetics of ACT-451840, a new chemical entity with antimalarial activity. Antimicrob Agents Chemother. 2015 Feb;59(2):935-42. doi: 10.1128/AAC.04125-14. Epub 2014 Nov 24.

family: Bruderer

full_name: Shirin Bruderer

given: Shirin

family: Hurst

full_name: Noémie Hurst

given: Noémie

family: de Kanter

full_name: Ruben de Kanter

given: Ruben

family: Miraval

full_name: Tommaso Miraval

given: Tommaso

family: Pfeifer

full_name: Thomas Pfeifer

given: Thomas

family: Donazzolo

full_name: Yves Donazzolo

given: Yves

family: Dingemanse

full_name: Jasper Dingemanse

given: Jasper

journal_name: Antimicrobial Agents and Chemotherapy

evidence: open (via free pdf)

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

title: First-in-Humans Study of the Safety, Tolerability, and Pharmacokinetics of ACT-451840, a New Chemical Entity with Antimalarial Activity

lead_sponsor: Idorsia Pharmaceuticals Ltd.


title: Comparison of Cognitive and Behavioral Dysexecutive Syndrome Between Parkinsonian Form and Cerebellar Form of Multiple System Atrophy and Analysis of Correlates With an Imaging Study.

acronym: CogAMS

summary: The main objective of the study is to compare the score to the Behavioral Dysexecutive Syndrome Inventory (BDSI) between Parkinsonian Multiple system Atrophy MSA-P patients and cerebellar Multiple System Atrophy (MSA-C) patients matched on disease duration, age (± 7 years) and sex .


title: Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections.

summary:
The aim of this study is divided in 4 different steps:

the first step has two different purpose: assess the impact of the storage medium of fresh prostatic chips on fluorescence signal and adjust the entire chain (immunolabelling,counter-stain and imaging),
the second step is the adaptation of immunolabelling protocol on histopathology slides, using fresh prostatic tissue,

the third step is to validate the use of:

the medical device created by the FEMTO-ST institute use for the detection of fluorescence signal on fresh tissue,
the Light-CT scanner use for tissue structural observation.
the four step is to check the preservation of morphological structure of tissue under the effect of laser excitation from the medical device.

location_facility: Grenoble University Hospital, Urology and Anatomopathology Department


title: Autograft of Human Ovarian Tissue: Efficiency and Safety Evaluation

acronym: CAROLéLISA

summary:
Ovarian tissue cryopreservation is a new technique for female fertility preservation. One way to restore fertility is autotransplantation of ovarian tissue.

The principal purpose of this study will be to evaluate the efficiency and safety of this procedure.

ReferenceCitation: Vatel M, Torre A, Paillusson B, Scheffler F, Bergere M, Benkhalifa M, Le Martelot MT, Leperlier F, Mirallié S, Selleret L, Prades-Borio M, Neuraz A, Barraud-Lange V, Boissel N, Fortin A, Poirot C. Efficacy of assisted reproductive technology after ovarian tissue transplantation in a cohort of 11 patients with or without associated infertility factors. J Assist Reprod Genet. 2021 Feb;38(2):503-511. doi: 10.1007/s10815-020-02033-9. Epub 2021 Jan 3.

family: Vatel

full_name: M. Vatel

given: M.

family: Torre

full_name: A. Torre

given: A.

family: Paillusson

full_name: B. Paillusson

given: B.

family: Scheffler

full_name: F. Scheffler

given: F.

family: Bergere

full_name: M. Bergere

family: Benkhalifa

full_name: M. Benkhalifa

family: Le Martelot

full_name: M.-T. Le Martelot

family: Leperlier

full_name: F. Leperlier

family: Mirallié

full_name: S. Mirallié

given: S.

family: Selleret

full_name: L. Selleret

given: L.

family: Prades-Borio

full_name: M. Prades-Borio

family: Neuraz

full_name: A. Neuraz

family: Barraud-Lange

full_name: V. Barraud-Lange

given: V.

family: Boissel

full_name: N. Boissel

given: N.

family: Fortin

full_name: A. Fortin

family: Poirot

full_name: C. Poirot

given: C.

journal_name: Journal of Assisted Reproduction and Genetics

ReferenceCitation: Poirot C, Fortin A, Lacorte JM, Akakpo JP, Genestie C, Vernant JP, Brice P, Morice P, Leblanc T, Gabarre J, Delmer A, Badachi Y, Drouineaud V, Gouy S, Chalas C, Egels S, Dhédin N, Touraine P, Dommergues M, Lebègue G, Wolf JP, Capron F, Lefebvre G, Boissel N; CAROLéLISA Cooperative Group. Impact of cancer chemotherapy before ovarian cortex cryopreservation on ovarian tissue transplantation. Hum Reprod. 2019 Jun 4;34(6):1083-1094. doi: 10.1093/humrep/dez047.

name: Department of Hematology, Adolescents and Young Adults Unit, Fertility Preservation, Assistance Publique-Hôpitaux de Paris (AP-HP) Saint Louis Hospital, Paris, France

name: Médecine Sorbonne Université, Paris, France

full_name: C Poirot

given: C

name: Department of Obstetrics Gynecology, AP-HP Pitié-Salpêtrière—Charles Foix University Hospital, Paris, France

full_name: A Fortin

given: A

name: Department of Hormonal Biochemistry, AP-HP Pitié-Salpêtrière—Charles Foix University Hospital, Paris, France

family: Lacorte

full_name: J M Lacorte

given: J M

name: Department of Radiology, AP-HP Pitié-Salpêtrière—Charles Foix University Hospital, Paris, France

family: Akakpo

full_name: J P Akakpo

given: J P

name: Department of Pathology, Gustave Roussy Institute, Villejuif, France

family: Genestie

full_name: C Genestie

name: Department of Hematology, AP-HP Pitié-Salpêtrière—Charles Foix University Hospital, Paris, France

name: Department of Hematology/Oncology, AP-HP Saint Louis Hospital, Paris, France

name: Department of Oncological Surgery, Gustave Roussy Institute, Villejuif, France

name: Paris-Sud XI University, Le Kremlin-Bicêtre, France

name: Department of Pediatric Hematology, AP-HP Robert Debré University Hospital, Paris, France

name: Department of Clinical Hematology, Robert Debré Hospital, Reims, France

name: Reims Champagne-Ardenne University, Reims, France

name: Department of Reproductive Biology, AP-HP Cochin Hospital, Paris, France

name: Department of Endocrinology, AP-HP Pitié-Salpêtrière—Charles Foix University Hospital, Paris, France

name: Paris Descartes University, Paris, France

name: Department of Pathology, AP-HP Pitié-Salpêtrière—Charles Foix University Hospital, Paris, France

location_facility: Hôpital Tenon, service de Biologie de la reproduction


title: Impact of an Electronic Monitoring Device on Maintaining a Correct Elevation of Head of Bed for Mechanically-ventilated Patients in Intensive Care Unit

summary:
Maintaining mechanically-ventilated patients in semi-recumbent position (defined by a head of bed inclination between 30° and 45°) would decrease the risk of pneumopathy occurrence in those patients. However, such a bed inclination frame is still difficult to maintain in day-to-day care.

The aim of the study is to evaluate the impact of an electronic monitoring device on the proportion of time spent per day in semi-recumbent position, as defined by a head of bed inclination between 40° and 50°, in mechanically-ventilated patients.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Early Nutrition and Neurological Development of Very Preterm Infants

summary:
The main goal of this study is to determine, in preterm infants born with a GA < 32 weeks, the association between:

the quantity of mother's milk and duration and breastfeeding
the intake of polyunsaturated fatty acids and iron during hospitalizations

location_facility: Hôpital Necker Assistance Publique- Hôpitaux de Paris


title: Postoperative Analgesia After Caesarean Section Under ALR: TAP Block Versus Catheter Scar Infiltration

summary:
The purpose of the multimodal postoperative analgesia is to improve the quality of analgesia and reduce side effects of morphine (nausea, vomiting, sedation, urinary retention, respiratory depression ...). In the case of caesarean sections, the quality of analgesia allows one hand to improve the mother-child relationship and the quality of breastfeeding, the other to reduce the risk of postpartum depression and chronic pain . Two methods of administration of local anesthetics have been proven effective for analgesia of the abdominal wall under umbilical: The Transversus Abdominal Block Plan (TAP Block) and infiltration of the scar continues operating. The TAP block was performed under ultrasound guidance by the anesthesiologist after the intervention in a single injection of local anesthetic in the abdominal wall and has a period of limited and variable. The infiltration continues catheter is placed by the surgeon before closing the wound and allows the infusion of local anesthetics for 48 hours.

The purpose of this study was to compare morphine consumption between both techniques, and the quality of analgesia and side effects of morphine


title: Rôle Des Acides Epoxy-eicosatriénoïques et du Monoxyde d'Azote Dans l'hyperhémie Post-occlusive cutanée Digitale et la réponse cutanée au Froid Dans le phénomène de Raynaud Primaire

acronym: REFRAIN

summary: The main objective of the study is to determine if implication of epoxy-eicosatriénoïc acids (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.

primary_purpose: Basic Science


title: Single-center, Controlled, Randomized and Double-blind Study Evaluating the Laser Diode Effect on the Kinetics of Orthodontic Tooth Movement.

acronym: CINELASER

summary:
It is a single-center, prospective clinical study of a medical device, controlled, randomized, non-stratified, double-blind (neither the patient nor the parents know which area is irradiated / practitioner who performs the measures and evaluates the class I achievement or non also ignores the irradiated area) .

Children included in this clinical trial will be their own control, an area receiving LASER irradiation the other receiving a simulation LASER irradiation (placebo side, inactive laser) .

In the maxilla, it will be segmented using a technique by the introduction of sectional side (portion of elgiloy arch supporting molars, canines and premolars) which serve as a support for Intermaxillary Strength II (or Intermaxillary Elastics II).

The patient should put his own Intermaxillary Elastics II, force adapted to the amount of class II dental, and this 24h/24. The patient should position him/herself these intermaxillary elastics in the first mandibular molar to the maxillary canine ; their action, in case of maximum mandibular anchorage, is to reduce maxillary canine in order to obtain reports of class I. In the mandible, a maximum anchor will be realized. Maximum molar anchor is to place the roots of mandibular molars in the vestibular cortex in order to anchor them there. This allows the lower canines, premolars and maxillary molars under the action of FIM without causing mutual advancement of the mandibular arch.

This procedure does not differ from the usual treatment. The application of laser diode appears, by biomodulatrice action, to show promising results on accelerating the kinetics of tooth movement during orthodontic treatment. The main hypothesis of the research is an increase in the rate of correction of Class II irradiated side, i.e. a 1-month shortest delay in obtaining the class I for irradiated areas vs. non irradiated ones.

The main objective of this study is to evaluate the effect of the application of low energy laser (LLLT) on the time required to obtain a Class I canine on patients undergoing FIM II (Class II elastics)

ReferenceCitation: Pérignon B, Bandiaky ON, Fromont-Colson C, Renaudin S, Peré M, Badran Z, Cuny-Houchmand M, Soueidan A. Effect of 970 nm low-level laser therapy on orthodontic tooth movement during Class II intermaxillary elastics treatment: a RCT. Sci Rep. 2021 Dec 1;11(1):23226. doi: 10.1038/s41598-021-02610-7.

location_facility: CHU de NANTES - Service d'odontologie restauratrice et chirurgicale, UIC odontologie


title: ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae. A French, Observational, Prospective, Multicentric, Single Arm and Open Study

acronym: dAVF

summary: The objective of this study is to evaluate the safety and performance post last embolization with Onyx

lead_sponsor: Medtronic Neurovascular Clinical Affairs


summary:
The treatment of otolaryngology (OLR) cancer is based on surgery, radiation, sometimes used in combination with chemotherapy. Patients treated with radiotherapy have multiple oral diseases: mucositis, hyposalivation, tissue fibrosis, exacerbation of periodontitis. Over 70% of patients with head and neck cancers treated with radiotherapy have a lower level of dental clinical attachment and 92% have loose teeth or missing. The management of these oral complications is a priority in OLR oncology. The aim is to improve the oral health of patients to achieve a comfortable life acceptable and necessary for healing.

This project proposes to deepen the investigation with two main objectives:

To study in vivo the effect of radiation treatment on the evolution of the viral flora of the periodontium in a cohort of patients and matched controls.
To study in vitro the effects of irradiation on the replication EBV (herpesvirus) in producing websites lymphoepithelial tonsillar, and atypical dendritic cells associated with EBV that existence were recently discovered.


title: Reduce Nonsteroidal Antiinflammatory Drugs Doses for Analgesia After Sternotomy

acronym: LoDoNSAID

summary:
Currently, the management of pain after cardiac surgery is based on the concept of multimodal analgesia: Combined use of non-opioid analgesics associated with morphine intravenous analgesia by a system controlled by the patient (patient-controlled analgesia-PCA).

The combination of paracetamol and morphine PCA is very effective on pain at rest, but is limited on pain mobilization and causes the problem of side effects associated with opioid (overdose, sedation, respiratory depression, gastrointestinal intolerance, urinary retention ...) which are contributing factors to increase the length of stay in Intensive Care Unit, an additional cost of care and an increase postoperative morbidity and mortality.

Methods that have proved their effectiveness on pain and mobilization used in postoperative cardiac surgery are: anti-inflammatory drugs (NSAIDs) and / or loco-regional analgesia techniques. NSAIDs enhance analgesia produced by PCA Morphine and allow a reduction in morphine consumption, improved postoperative pain, decreased sedation and decreased postoperative morbidity and mortality.

Adverse effects of NSAIDs are commensurate with their time and exposure dose. Consequently, NSAIDs, in the absence of against-indications, should always be prescribed and used at the lowest effective dose and for the shortest possible time.

Some studies have suggested that lower doses of NSAIDs didn't appear to affect their effectiveness. At present, the investigators have no studies that address the hypothesis from which minimum dose of ketoprofen analgesic effect is obtained.

The investigators hypothesis is that lower dose ketoprofen may have efficacy on pain in the postoperative mobilization of cardiac surgery. The investigators want to find, in their study, this "optimal" ketoprofen dose which would be the minimum dose for clinical efficacy demonstrated dose.

This optimal dose could reduce the number of adverse effects of NSAIDs, but their study will probably not have enough power to prove it. NSAID use at these low doses, in postoperative cardiac surgery, could be extended to patient populations most at risk or for a duration longer than 48 hours.

ReferenceCitation: Eljezi V, Biboulet C, Boby H, Schoeffler P, Pereira B, Duale C. The Dose-Dependent Effects of Ketoprofen on Dynamic Pain after Open Heart Surgery. Pain Physician. 2017 Sep;20(6):509-520.

lead_sponsor: University Hospital, Clermont-Ferrand


acronym: CICLO-NOHL

summary:
The Leber Hereditary Optic Neuropathy is a genetic disorder caused by maternal transmission of mitochondrial DesoxiroboNucleid Acid mutations. It is manifested by a rapidly progressive blindness, profound, due to atrophic optic nerve. The visual loss is primarily unilateral bilateralisation taking place in the vast majority of cases in weeks or months. The neuro-cardio-protective properties of cyclosporine (and its analogs specifically targeting the anti-apoptotic mechanisms) are particularly promising.

The investigators hypothesis is that cyclosporine may limit apoptosis during the acute phase of the disease process and would limit the loss of visual acuity and improve the visual prognosis of these patients.

ReferenceCitation: Leruez S, Verny C, Bonneau D, Procaccio V, Lenaers G, Amati-Bonneau P, Reynier P, Scherer C, Prundean A, Orssaud C, Zanlonghi X, Rougier MB, Tilikete C, Miléa D. Cyclosporine A does not prevent second-eye involvement in Leber's hereditary optic neuropathy. Orphanet J Rare Dis. 2018 Feb 17;13(1):33. doi: 10.1186/s13023-018-0773-y.

family: Leruez

full_name: Stéphanie Leruez

given: Stéphanie

family: Verny

full_name: Christophe Verny

given: Christophe

family: Bonneau

full_name: Dominique Bonneau

given: Dominique

family: Procaccio

full_name: Vincent Procaccio

given: Vincent

family: Lenaers

full_name: Guy Lenaers

given: Guy

family: Amati-Bonneau

full_name: Patrizia Amati-Bonneau

given: Patrizia

family: Reynier

full_name: Pascal Reynier

given: Pascal

family: Scherer

full_name: Clarisse Scherer

given: Clarisse

family: Prundean

full_name: Adriana Prundean

given: Adriana

family: Orssaud

full_name: Christophe Orssaud

family: Zanlonghi

full_name: Xavier Zanlonghi

given: Xavier

family: Rougier

full_name: Marie-Bénédicte Rougier

given: Marie-Bénédicte

family: Tilikete

full_name: Caroline Tilikete

given: Caroline

family: Miléa

full_name: Dan Miléa

given: Dan

journal_name: Orphanet Journal of Rare Diseases

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

title: Cyclosporine A does not prevent second-eye involvement in Leber’s hereditary optic neuropathy


title: Usability of Virtual Reality in Subjects With Mild Cognitive Impairment or Alzheimer's Disease. MeMO-RV2

summary:
Cognitive and memory problems characterize Alzheimer's disease (AD). Along with these disorders, psychological and behavioral symptoms (also known as neuropsychiatric symptoms) , as well as pathophysiological processes are frequently found and involved significantly in maintaining autonomy, prognosis and treatment of the disease. Apathy or disorder motivation is the most common disorder behavior and early stages of cognitive impairment. Apathy is particularly associated with cognitive difficulties such as attention deficit disorder - concentration.

In terms of prevention as term care , there is now a broad consensus that interventions on cognition and behavior must not be limited to pharmacological treatment but should also promote non-drug approaches.

Interest in video games (serious games and serious games) as intervention support rehabilitation is growing. Similarly, the virtual reality (VR) and the new information technologies and communications offer significant opportunities in terms of rehabilitation and therapeutic assistance.

This protocol is part of a European project to propose techniques for improving the treatment of people at risk of social exclusion ( VERVE project ) aims .

A first experiment conducted in 2013 showed the acceptability of Virtual Reality (VR) in healthy elderly subjects. In a second step , it is important to validate the feasibility of using the RV or in frail subjects with mild cognitive impairment or Alzheimer's disease in mild to moderate in a clinical environment.

This is a biomedical , randomized given to a group of patients with mild cognitive impairment or Alzheimer's disease & diseases associated with mild to moderate.


summary: A prospective, open label, study evaluating JUVÉDERM® VOLBELLA with lidocaine treatment for the correction of skin depressions in the infra-orbital area (under the eyes)

ReferenceCitation: Niforos F, Acquilla R, Ogilvie P, Safa M, Signorini M, Creutz L, Kerson G, Silberberg M. A Prospective, Open-Label Study of Hyaluronic Acid-Based Filler With Lidocaine (VYC-15L) Treatment for the Correction of Infraorbital Skin Depressions. Dermatol Surg. 2017 Oct;43(10):1271-1280. doi: 10.1097/DSS.0000000000001127.

lead_sponsor: Allergan


title: Rôle Pronostique Des métabolismes du Stress Oxydatif et du Fer Dans Les Leucémies Aiguës Myéloblastiques

acronym: LAM-ROS

summary: In this study, the investigators study the prognostic role of oxidative stress metabolism and iron in Acute myeloid leukemia.


title: Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System

acronym: IKONE

summary: The purpose of this study is to report the stability of atrial and ventricular leads by absence of effect of the MRI exam on the pacing and sensing threshold and to report the safety based on the serious adverse events.

lead_sponsor: MicroPort CRM


title: Low and High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Resistant Auditory Hallucination in Schizophrenia: a Double Blind Sham-controlled Randomised Study

acronym: rTMS

summary: Auditory Hallucinations (AH) are experienced by 50 to 70% of subjects with schizophrenia. Almost a quarter of patients are medication resistant to such symptoms. The application of rTMS at low frequency in the left temporoparietal cortex reduces AH. A pilot study reported successful treatment of AH with high frequency rTMS. rTMS (20Hz) should be a shorter and an easier treatment for out-patients with schizophrenia compared to low stimulation treatment.

location_facility: Department of Psychiatry, Louis Mourier Hospital


title: A Unicentric, Open Label, Mechanism of Action Trial, on the Biological Effect of Nab-paclitaxel Combined to Gemcitabine, in Patients With Metastatic Pancreatic Adenocarcinoma

summary:
The prognostic of metastatic pancreatic adenocarcinoma is dismal and the treatment gold standard since the end of the 90s' is gemcitabine; unfortunately all trials testing combinations of gemcitabine with chemotherapeutic agents or targeted agents had failed to demonstrate any superiority over gemcitabine monotherapy.

In a recently published phase I/II study of combination of gemcitabine plus nab-paclitaxel in patients with metastatic pancreatic adenocarcinoma (PAC), the combination gave an impressive response rate of 48% (Gemcitabine 1g/m² and nab-paclitaxel 125 mg/m² once a week for 3 weeks, every 4 weeks). The safety profile was correct (fatigue, sensory neuropathy, nausea, haematological side effects). This efficacy can be related to an improvement of gemcitabine delivery to the tumor bed, as shown on preclinical studies: the response rate in xenografts was better with the combination; this improvement was associated with an increase of intratumoral gemcitabine concentration in mice receiving the combination when compared to mice receiving gemcitabine alone. This might be associated to modifications of peritumoral stroma with reduction of stromal content and increase in dilated vessels.

The aim of this study is to evaluate if the combination of nab-paclitaxel plus gemcitabine induces a modification in vascularization of pancreatic adenocarcinoma on the primary tumor and of liver metastases after 2 cycles of treatment by comparison to baseline.

lead_sponsor: Institut Paoli-Calmettes


title: Concordance of Pain Detection in Patients by Doloplus® and Algoplus® Behavioural Scales.

acronym: CALDOL

summary:
The pain of the elderly is often trivialized and ignored in spite of its high frequency: the chronic pain affects 50 % of the elderly living at home, 49 to 83 % of those living in institution and 80 % of this population at the end of life.

The evaluation of pain appeals to the same strategy as to the younger subject but with some specificities, related more to the pathologies associated with the ageing than to the real age. For that purpose, the investigators have self-assessment scales as the Numeric Pain Rating Scale which is adapted to estimate acute and chronic pains, but this scale presents a bias because, some patients do not express spontaneously their pain.

So behavioural scales were elaborated to solve the difficulties of detection and to care the pain of the elderly. The Algoplus® scale (5 items which takes less than one minute to be completed) whose objective is the observation of behavioural changes caused by the acute pain in elderly having communication disorders. The Doloplus® scale (30 items which allow in few minutes a good evaluation of pain) whose objective is the observation of behavioural changes caused by the chronic pain in elderly having communication impairments.

In practice, because of its popularity, the Algoplus® scale is widely used out of the specificity in which it has been validated. Practitioners, worried about this misuse, suggested to Doloplus® group, to test the concordance between the two behavioural scales in order to develop recommendations more targeted. The risk is that the use of the Algoplus® scale may underestimate pain that would have been detected by Doloplus® scale, and lead to under-treatment or non-treatment of pain in elderly having communication disorders.

This study aims to establish the concordance between these two scales to generate advices and recommendations to assess efficiently the pain in this vulnerable population.

The main objective of this study is to assess whether the use of Algoplus® scale is in good concordance with Doloplus® scale.

The secondary objective of this study is to assess the concordance with different levels of Algoplus® pain scale: (0-1), (2-3), (4-5).


title: A Pharmacokinetic Drug Interaction and Tolerance Study of Paracetamol and Nefopam

acronym: PARA-NEF

summary: Pain remains the leading cause of consultation. Despite a wide therapeutic arsenal, a significant percentage of patients disclaim little or no pain relief with common analgesics, specific or not their type of pain. This is especially true in cases of chronic pain, and current treatments are associated with many side effects. A need for therapeutic innovation is needed. Paracetamol is currently the most widely used analgesic worldwide but despite its excellent safety, its analgesic effect is limited from moderate to severe pain. Many analgesic drug combinations include paracetamol, recently the co-administration of paracetamol and nefopam showed a supra-additive antinociceptive effect (Van Elstraete AC et al. 2013). The development of a formulation associating paracetamol and nefopam first requires searching a possible pharmacokinetic interaction between the two active substances and assessing safety of this combination in healthy volunteers. No published studies providing such information.


title: Reduction of the Duration of Antibiotic Guided by Procalcitonin in Infections Lungs of Hospitalized Elderly: a Randomized

acronym: PROPAGE

summary: The main objective is to evaluate the interest of the repeated measurement of procalcitonin in patients with pulmonary infection to reduce the duration of antibiotic therapy in comparison with a conventional clinical strategy.

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ReferenceCitation: Singh N, Rogers P, Atwood CW, Wagener MM, Yu VL. Short-course empiric antibiotic therapy for patients with pulmonary infiltrates in the intensive care unit. A proposed solution for indiscriminate antibiotic prescription. Am J Respir Crit Care Med. 2000 Aug;162(2 Pt 1):505-11.

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ReferenceCitation: Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Müller B. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet. 2004 Feb 21;363(9409):600-7.

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ReferenceCitation: Stolz D, Christ-Crain M, Bingisser R, Leuppi J, Miedinger D, Müller C, Huber P, Müller B, Tamm M. Antibiotic treatment of exacerbations of COPD: a randomized, controlled trial comparing procalcitonin-guidance with standard therapy. Chest. 2007 Jan;131(1):9-19.

ReferenceCitation: Schuetz P, Christ-Crain M, Wolbers M, Schild U, Thomann R, Falconnier C, Widmer I, Neidert S, Blum CA, Schönenberger R, Henzen C, Bregenzer T, Hoess C, Krause M, Bucher HC, Zimmerli W, Müller B; ProHOSP study group. Procalcitonin guided antibiotic therapy and hospitalization in patients with lower respiratory tract infections: a prospective, multicenter, randomized controlled trial. BMC Health Serv Res. 2007 Jul 5;7:102.

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title: Chronic Pain and Social Vulnerability: Prevalence and Predictive Factors of the Social Vulnerability in Evaluation and Treatment of the Pain Center (CETD)

acronym: PRECAPAIN

summary:
In the care of the chronic pain in pain's department, pain consultation or Evaluation and Treatment of the Pain Center (CETD), the patients are often in a situation of physical and psychic suffering which requires a multidisciplinary follow-up. So, 19 percent of the chronic painful patients lost their employment, are "disintegrated" because of their pain, this being able to provocate a loss of their financial autonomy. A large number of painful patients thus find themselves in situations of social vulnerability even of precariousness often denied and difficult to detect by the caring team. Precarity is define as " the lack of one or several securities, in particular the employment, allowing the people and the families to assume their professional, family or social obligations, and to enjoy their fundamental rights." To allow a earlier identification of the populations in deprivation situation, the questionnaire EPICES (Evaluation of the Precariousness and the Disparities of health for the Centers of Examination of Health (CES)) was administered to more than 7000 people. The individual score, indicator of the precariousness and the disparities of health, is calculated after answer to 11 questions and was calculated on about 200 000 French people. Among numerous indicators, it appears that the consumption of psychotropics or a negative perception of the health are socioeconomic indicators, mode of life and health which are prevailing according to the quintiles of the score EPICES.

This national study, on the French CETD aims is: 1 - to study prevalence of the social vulnerability even of the precariousness thanks to adapted questionnaires of which the questionnaire EPICES, 2 - to identify predictive social-economic factors which generate and amplify this circumstance, 3 - to identify the patients for whom a situation of precariousness and social vulnerability is proved true, justifying the earlier orientation towards the social worker of the Center so allowing a "global" care of the patient during the second visit


title: Medial Prefrontal Cortex and Vulnerability for Depression

acronym: CORVAD

summary: To examine whether the medial prefrontal cortex displays an increased activity during self-referential processing among remitted depressed patients compared to healthy controls

ReferenceCitation: Lemogne C, Delaveau P, Freton M, Guionnet S, Fossati P. Medial prefrontal cortex and the self in major depression. J Affect Disord. 2012 Jan;136(1-2):e1-e11. doi: 10.1016/j.jad.2010.11.034. Epub 2010 Dec 23. Review.


title: Comparison of Functional Recovery After Pertrochanter Fracture Treated With Either Total Hip Replacement or Centromedullary Nailing

acronym: PAVO

summary:
This is a single-centre, comparative, prospective randomised trial. It will include 70 patients over a period of 2 years randomized into two groups of 35 patients: one group of patients treated with osteosynthesis (plate, nail or screw) and the second group treated with total hip replacement.

The Harris and PMA functional scores will be assessed at 6 weeks, 3 months, 6 months and 1 year.

The time to recovery of weight-bearing, the subjective satisfaction score, the EQ5D quality of life questionnaire, the VAS score for pain at rest and when walking, the Parker score, the rate of complications and deaths will also be measured. Operating time, blood loss and scar size will also be evaluated.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Mechanisms and Factors Responsible for the Inhibition of Transposons During Fetal Gonad Development in Humans

summary: This is a single-centre study over 36 months for the inclusion of 30 patients. The selection and inclusion of patients will take place according to the criterion of Medical Termination of Pregnancy at 4 different gestational ages (8-12 weeks of gestation (WG)), 13-16 WG, 17-23 WG and 25-35 WG. The tissue analysed will principally be the gonads, other somatic tissue will also be systematically harvested in parallel (liver and psoas muscle) for control purposes. The gonads will be subjected to molecular biology analyses destined to quantify the expression of transposons and their inhibitors.


title: Quadricipital Electrical Stimulation in COPD Patients Rehabilitation

acronym: Reha-Res

summary:
Quadricipital electrical stimulation added to respiratory rehabilitation in COPD patients.

Quadricipital electrical stimulation (ES) in chronic obstructive pulmonary disease (COPD) patients has been demonstrated to improve both dyspnea and physical status. The aim of our study is to demonstrate that ES added to respiratory rehabilitation program induces a greater improvement on exercise tolerance in such patients.

Design : 160 patients with severe COPD will be randomly assigned to 2 groups : either rehabilitation program (group 1), either ES and rehabilitation program (group 2). In both groups, rehabilitation program comprises endurance training, 18 - 24 sessions (6 - 8 weeks), health education, global muscular strengthening. In group 2, bilateral quadricipital electrical stimulation 30 min sessions is added 5 days / week.

Subjects : COPD patients with FEV1 < 60% pred, FEV1/VC < 70%, and TLC > 80%, with dyspnea, in stable conditions, and 18 > BMI < 35 kg/m² .

Intervention : 6 min walking distance, incremental exercise test data (aerobic capacity, work rate, ventilatory threshold), physical activity with activity monitor, health related quality of life will be determined before and after training.

Abbreviations : FEV1 = forced expiratory volume in 1 sec; VC = vital capacity; TLC = total lung capacity; BMI = body mass index.

ReferenceCitation: Bonnevie T, Gravier FE, Debeaumont D, Viacroze C, Muir JF, Cuvelier A, Netchitaïlo M, Roy AL, Quieffin J, Marques MH, Médrinal C, Dupuis J, Tardif C. Home-based Neuromuscular Electrical Stimulation as an Add-on to Pulmonary Rehabilitation Does Not Provide Further Benefits in Patients With Chronic Obstructive Pulmonary Disease: A Multicenter Randomized Trial. Arch Phys Med Rehabil. 2018 Aug;99(8):1462-1470. doi: 10.1016/j.apmr.2018.01.024. Epub 2018 Feb 16.

family: Bonnevie

full_name: Tristan Bonnevie

given: Tristan

family: Gravier

full_name: Francis-Edouard Gravier

given: Francis-Edouard

family: Debeaumont

full_name: David Debeaumont

given: David

family: Viacroze

full_name: Catherine Viacroze

given: Catherine

family: Muir

full_name: Jean-François Muir

given: Jean-François

family: Cuvelier

full_name: Antoine Cuvelier

given: Antoine

family: Netchitaïlo

full_name: Marie Netchitaïlo

given: Marie

family: Roy

full_name: Anne-Laure Roy

given: Anne-Laure

family: Quieffin

full_name: Jean Quieffin

given: Jean

family: Marques

full_name: Marie-Hélène Marques

given: Marie-Hélène

family: Médrinal

full_name: Clément Médrinal

given: Clément

family: Dupuis

full_name: Johan Dupuis

given: Johan

family: Tardif

full_name: Catherine Tardif

journal_name: Archives of Physical Medicine and Rehabilitation