title: Daycare Environmental Exposure to Cleaning Products and Respiratory Health in Young Children and Daycare Workers

acronym: CRESPI

summary:
CRESPI - RESPIratory health of Children in daycare

The CRESPI study, will be a cohort of 1500/2000 children attending daycare in Paris region, and will be initiated in November 2019.

The aim of the project is to study the impact of environmental exposures to cleaning products and disinfectants on respiratory health of infants and toddlers (< 3 years) in daycares

Two specific aims were defined:

evaluate environmental exposure to cleaning products by complementary and innovative tools: air quality measurements in daycares, specific standardized questionnaire, identification of compounds of the products via a database and a Smartphone application to scan bar codes and inform on product use
evaluate the impact of early exposure in daycares and at home on respiratory health of young children

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


title: Comparison of the Benefit Experienced by Patients With Ankylosing Spondylitis, Under Biotherapy, During Management by an Adapted Physical Activity Compared to a Standard Treatment by Kinesitherapy.

acronym: SPIKE

summary:
The current management of Spondylarthritis Ankylosant (SA), according to the recommendations of the HAS (High Authority of Health), must be a multidisciplinary global approach coordinated by the rheumatologist combining a pharmacological aspect (NSAID, analgesics, biotherapy ...) and not pharmacological (physical treatments, educational approaches, social measures ...). The therapeutic aim of this management is to achieve a low level of activity of the disease and a decrease of the repercussion of this one in the daily life of the patient.

The standard physical treatment currently provided is physiotherapy. This can be prescribed throughout the disease by the rheumatologist, adapted to the stage of AS and the clinical condition of the patient. The medical teams note in their daily practice that there may be a lack of attendance of patients at prescribed physiotherapy sessions. This has been confirmed in research on certain chronic rheumatic diseases, including AS, for which patients became less adherent to physical treatments and thus lost the expected benefits, particularly in terms of the functional impact of AS in the patient's daily life. (BASFI). Various studies have also shown that combining several physical activities (including aerobic and muscle building) or / and performing them in groups at a regular frequency (three times a week) could significantly improve several AS parameters, including BASFI.

From these different findings, we hypothesized that a multidisciplinary treatment combining a "cardio training" with muscle strengthening, supervised by qualified sports coaches, for a year, could reduce the impact of SA in the daily life of patients balanced by a biotherapy, compared to standard physiotherapy. This original care is part of the Adapted Physical Activity (APA), whose application decree came into force on March 1, 2017 and allows doctors to prescribe a physical therapy tailored to the needs of the patient. At present, the APA remains at the expense of the patients in ALD and in some cases, it can be supported, partially or totally, by the complementary health. APA could therefore be an alternative and / or complementary to physiotherapy as a physical therapy in the management of AS, in addition to pharmacological treatments.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Hospital St. Joseph, Marseille, France

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Ongoing


title: Monocentric Study Evaluating the Efficiency and Safety of Anti-reflux Mucosectomy ARMS for the Gastro-Esophageal Reflux Disease

acronym: RESECT-RGO

summary:
Currently patients with gastroesophageal reflux disease (GERD) are treated with proton pump inhibitors (PPIs). This long-term PPI treatment would likely increase the risk of pulmonary and digestive infections and would not prevent evolution to adenocarcinoma of Barrett's Esophagus. Surgical fundoplication is generally recommended when symptoms are poorly controlled with PPIs and considered as standard treatment despite celioscopy risk. A variety of endoscopic techniques for the treatment of GERD has been proposed to obtain non-surgical control. These endoscopic techniques aim to bring the tissues closer to the Œsogastric (JOG) junction. But a low response rate has been demonstrated with these techniques.

H. Inoue (inventor of the anti-reflux mucosectomy 20 years ago) and his team postulated that the reflux symptoms would be reduced by creating a relative restriction of gastric cardia. The healing of the mucosectomy zone led to restriction of gastric cardia. This observation suggested that ARMS could represent an effective anti-reflux procedure with the advantage that no prostheses would be left in situ.

Few studies have evaluated this new endoscopic technique. The purpose of this study is to evaluate the feasibility and safety of gastric mucosectomy for patients with GERD resistant to medical treatment or requiring long-term maintenance medical treatment.

status: Suspended

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Galmiche JP, Hatlebakk J, Attwood S, Ell C, Fiocca R, Eklund S, Långström G, Lind T, Lundell L; LOTUS Trial Collaborators. Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial. JAMA. 2011 May 18;305(19):1969-77. doi: 10.1001/jama.2011.626.

family: Galmiche

full_name: Jean-Paul Galmiche

given: Jean-Paul

sequence: first

family: Hatlebakk

full_name: Jan Hatlebakk

given: Jan

sequence: additional

family: Attwood

full_name: Stephen Attwood

given: Stephen

family: Ell

full_name: Christian Ell

given: Christian

family: Fiocca

full_name: Roberto Fiocca

given: Roberto

family: Eklund

full_name: Stefan Eklund

given: Stefan

family: Långström

full_name: Göran Långström

given: Göran

family: Lind

full_name: Tore Lind

given: Tore

family: Lundell

full_name: Lars Lundell

given: Lars

family: LOTUS Trial Collaborators

full_name: for the LOTUS Trial Collaborators

given: for the

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JAMA

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Laparoscopic Antireflux Surgery vs Esomeprazole Treatment for Chronic GERD

ReferenceCitation: Cicala M, Emerenziani S, Guarino MP, Ribolsi M. Proton pump inhibitor resistance, the real challenge in gastro-esophageal reflux disease. World J Gastroenterol. 2013 Oct 21;19(39):6529-35. doi: 10.3748/wjg.v19.i39.6529. Review.

family: Cicala

full_name: Michele Cicala

given: Michele

journal_name: World Journal of Gastroenterology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

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)

publisher: Baishideng Publishing Group Inc.

publisher_dissemination: Baishideng Publishing Group Inc.

publisher_group: Baishideng Publishing Group Inc.

publisher_normalized: Baishideng Publishing Group Inc.

ReferenceCitation: Kellokumpu I, Voutilainen M, Haglund C, Färkkilä M, Roberts PJ, Kautiainen H. Quality of life following laparoscopic Nissen fundoplication: assessing short-term and long-term outcomes. World J Gastroenterol. 2013 Jun 28;19(24):3810-8. doi: 10.3748/wjg.v19.i24.3810.

family: Kellokumpu

full_name: Ilmo Kellokumpu

given: Ilmo

repository_normalized: HELDA - Digital Repository of the University of Helsinki

repositories_institution:
PubMed Central - Europe PMC
University of Helsinki - Helda

title: Quality of life following laparoscopic Nissen fundoplication: Assessing short-term and long-term outcomes

ReferenceCitation: Marret H, Pierre F, Chapron C, Perrotin F, Body G, Lansac J. [Complications of laparoscopy caused by trocars. Preliminary study from the national registry of the French Society of Gynecologic Endoscopy]. J Gynecol Obstet Biol Reprod (Paris). 1997;26(4):405-12. French.

ReferenceCitation: Rickenbacher N, Kötter T, Kochen MM, Scherer M, Blozik E. Fundoplication versus medical management of gastroesophageal reflux disease: systematic review and meta-analysis. Surg Endosc. 2014 Jan;28(1):143-55. doi: 10.1007/s00464-013-3140-z. Epub 2013 Sep 10. Review. Erratum in: Surg Endosc. 2014 Jun;28(6):2002.

ReferenceCitation: Mahmood Z, Byrne PJ, McMahon BP, Murphy EM, Arfin Q, Ravi N, Weir DG, Reynolds JV. Comparison of transesophageal endoscopic plication (TEP) with laparoscopic Nissen fundoplication (LNF) in the treatment of uncomplicated reflux disease. Am J Gastroenterol. 2006 Mar;101(3):431-6.

ReferenceCitation: Triadafilopoulos G. Stretta: a valuable endoscopic treatment modality for gastroesophageal reflux disease. World J Gastroenterol. 2014 Jun 28;20(24):7730-8. doi: 10.3748/wjg.v20.i24.7730. Review.

title: Stretta: A valuable endoscopic treatment modality for gastroesophageal reflux disease

ReferenceCitation: Feretis C, Benakis P, Dimopoulos C, Dailianas A, Filalithis P, Stamou KM, Manouras A, Apostolidis N. Endoscopic implantation of Plexiglas (PMMA) microspheres for the treatment of GERD. Gastrointest Endosc. 2001 Apr;53(4):423-6.

ReferenceCitation: Cicala M, Gabbrielli A, Emerenziani S, Guarino MP, Ribolsi M, Caviglia R, Costamagna G. Effect of endoscopic augmentation of the lower oesophageal sphincter (Gatekeeper reflux repair system) on intraoesophageal dynamic characteristics of acid reflux. Gut. 2005 Feb;54(2):183-6.

ReferenceCitation: Wong RF, Davis TV, Peterson KA. Complications involving the mediastinum after injection of Enteryx for GERD. Gastrointest Endosc. 2005 May;61(6):753-6.

ReferenceCitation: Chuttani R, Sud R, Sachdev G, Puri R, Kozarek R, Haber G, Pleskow D, Zaman M, Lembo A. A novel endoscopic full-thickness plicator for the treatment of GERD: A pilot study. Gastrointest Endosc. 2003 Nov;58(5):770-6.

ReferenceCitation: Cadière GB, Buset M, Muls V, Rajan A, Rösch T, Eckardt AJ, Weerts J, Bastens B, Costamagna G, Marchese M, Louis H, Mana F, Sermon F, Gawlicka AK, Daniel MA, Devière J. Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study. World J Surg. 2008 Aug;32(8):1676-88. doi: 10.1007/s00268-008-9594-9.

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

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

repository_institution: The Pennsylvania State University - CiteSeer X

repositories:
CiteSeerX
PubMed Central
dipot.ulb.ac.be

title: Antireflux Transoral Incisionless Fundoplication Using EsophyX: 12-Month Results of a Prospective Multicenter Study

ReferenceCitation: Satodate H, Inoue H, Yoshida T, Usui S, Iwashita M, Fukami N, Shiokawa A, Kudo SE. Circumferential EMR of carcinoma arising in Barrett's esophagus: case report. Gastrointest Endosc. 2003 Aug;58(2):288-92.

ReferenceCitation: Inoue H, Ito H, Ikeda H, Sato C, Sato H, Phalanusitthepha C, Hayee B, Eleftheriadis N, Kudo SE. Anti-reflux mucosectomy for gastroesophageal reflux disease in the absence of hiatus hernia: a pilot study. Ann Gastroenterol. 2014;27(4):346-351.

ReferenceCitation: Velanovich V, Vallance SR, Gusz JR, Tapia FV, Harkabus MA. Quality of life scale for gastroesophageal reflux disease. J Am Coll Surg. 1996 Sep;183(3):217-24.


title: A Prospective Study Comparing the Evolution of Visual Acuity Measured by Electronic Tablet or Computer and the Visual Acuity Measured by ETDRS in Patients Monitored and Treated for Exudative AMD

summary:
This pathology, DMLA, whose evolution is chronic, requires regular follow-up and care (IVTs) over a long period (several months or even years).

Increasing the number of patients to be followed and treated poses increasing problems for ophthalmologists to ensure regular follow-up of patients, followed by a need for satisfactory functional results.

Moreover, this regular follow-up imposes enormous constraints on patients and their families (some children or patients are still working).

Studies are beginning to emerge on the reliability of patient follow-up in telemedicine. The use of a measure of visual acuity by patients, Electronic Tablet (TE) or computer (O), and at home, seems a logical step to help us improve the quality of patient follow-up while spacing controls.

The aim of our study is thus to demonstrate that the measurement of the VA performed by TE or O is reliable. Indeed, during the follow-up of the patients, in the case where the patient's AV decreases, and whatever the reason

status: Unknown status

primary_purpose: Prevention

intervention_type: Other

status_simplified: Unknown


title: Study GO-PRP: Assessing the Efficacy of Intra Articular Injection of Platelets Rich Plasma for Gonarthrosis Treatment in Routine Care

summary: This monocentric protocol is designed to evaluate the efficacy of therapeutic management of symptomatic knee osteoarthritis (resistant to medical first-line treatment) by intra-articular injection of autologous PRP prepared in the same procedure and using a dedicated CE marked medical device and a validated and reproducible method of preparation

intervention_type: Biological


title: Evaluation of the Prevalence of Asthma in a Cohort of Children Born After In Vitro Fertilization (Aged 11-15) Compared With Spontaneously Conceived Children of the Same Age Range

acronym: EMCeFIV

summary:
Assisted Reproduction Technologies (ART) are increasingly being used worldwide as a result of fertility decline likely caused by changes in both environment and social behaviour. Considering this large usage, it is important to evaluate the potential risk on the health of children conceived using ART.

According to the literature, children born after ART are more likely to be at higher risk of health problems than spontaneously conceived ones. Interestingly, recent studies suggested an increase of asthma prevalence in children conceived using In Vitro Fertilization (IVF).

The purpose of this study is to evaluate the prevalence of asthma in school adolescents from a cohort of children born after In Vitro Fertilization (IVF), aged 11-15 years as compared to a control group composed of the same age range spontaneously conceived individuals.

The expected outcome of this study will provide new information regarding these children to ART professionals of and to their own families, by focusing on an age range (between 11 and 15 years) for which very little information is available to date.

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Anzola AB, Pauly V, Geoffroy-Siraudin C, Gervoise-Boyer MJ, Montjean D, Boyer P. The first 50 live births after autologous oocyte vitrification in France. J Assist Reprod Genet. 2015 Dec;32(12):1781-7. doi: 10.1007/s10815-015-0603-2. Epub 2015 Oct 30.

ReferenceCitation: Meddeb L, Boyer M, Pauly V, Tourame P, Rossin B, Pfister B, Boyer P. [Procedure used to follow-up a cohort of IVF children. Interests and limits of tools performed to longitudinal follow up for a monocentric cohort]. Rev Epidemiol Sante Publique. 2011 Apr;59(2):97-105. doi: 10.1016/j.respe.2010.11.004. Epub 2011 Mar 22. French.


title: Monocentric Retrospective Observational Study Describing the Visual Acuity of Patients With Exudative Age Related Macular Degeneration and Treated by Lucentis® Under Real Conditions of Care.

acronym: ELOUAN

summary: Main Objective: The main objective of this retrospective observational study was to describe the evolution of visual acuity measured on ETDRS (Early Treatment Diabetic Retinopathy Study) scale, for patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care, in terms of mean change of the Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).

time_perspective: Retrospective


title: Phase IV Study Comparing Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Intravenous Chemotherapy

acronym: PACPAC-EPOC

summary:
The aim of this study is to compare the humeral and thoracic implantation of a central venous access by an implantable device in patients with solids tumors who require intravenous chemotherapy. This is a monocentric randomized study. 572 patients will be recruited for 2 years. They will be randomized either in the thoracic implantation, either in the humeral implantation Due to the 1:3 randomization, 143 patients will be randomized in the humeral arm and 429 into the thoracic one. Number of complications related to the implantable device, medico-economic analysis as well as patient satisfaction will be assessed.

Every patients with solid tumor requiring medical device implantation for intravenous chemotherapy treatment will be eligible.

Both humeral and thoracic implantation of medical device are standard procedures. The randomization in a specific arm is the study procedure and is considered as an interventional study in France.

primary_purpose: Other

lead_sponsor: Center Eugene Marquis

intervention_type: Device

lead_sponsor_type: industriel


title: Validity Assessment of the "LabForGames Warning" Serious Game

summary:
The use of simulation in medical education has been associated with positive results in the acquisition of knowledge, skills, behaviors and patient outcome. Serious games are useful educational tools since they allow both theory and practice training for an important number of learners, simultaneously. However, few studies have evaluated the validity and effectiveness of serious games.

Our simulation unit (LabForSIMS- Faculté de Médecine Paris-Sud, France) has developed a serious game named "LabForGames Warning" for nursing students with the following learning objectives: to recognize and to address the degradation of a patient's clinical condition and to work on the issue of inter-professional communication. The aim of the present study is to determine content and construct validities of the "LabForGames Warning" serious game before its use as a healthcare professional training tool.

status: Completed

study_completion_date_type: Actual

ReferenceType: derived

ReferenceCitation: Blanié A, Amorim MA, Meffert A, Perrot C, Dondelli L, Benhamou D. Assessing validity evidence for a serious game dedicated to patient clinical deterioration and communication. Adv Simul (Lond). 2020 May 27;5:4. doi: 10.1186/s41077-020-00123-3. eCollection 2020.

family: Blanié

full_name: Antonia Blanié

given: Antonia

family: Amorim

full_name: Michel-Ange Amorim

given: Michel-Ange

family: Meffert

full_name: Arnaud Meffert

given: Arnaud

family: Perrot

full_name: Corinne Perrot

given: Corinne

family: Dondelli

full_name: Lydie Dondelli

given: Lydie

family: Benhamou

full_name: Dan Benhamou

given: Dan

currency_apc_doaj: GBP

journal_name: Advances in Simulation

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Université Paris-Sud

status_simplified: Completed


title: Promoting Parental Skills and Enhancing Attachment in Early Childhood

acronym: CAPEDP

summary: Child psychological/behavioural disorders such as withdrawal may persist when the psychosocial context is unfavourable. Health promotion strategies (Olds' paradigm) have proved their efficacy in vulnerable populations. CAPEDP project sets out to evaluate a program of home visits in France

ReferenceCitation: Dugravier R. [Understanding consequences of hospitalization within attachment theory]. Arch Pediatr. 2010 Jun;17(6):723-4. doi: 10.1016/S0929-693X(10)70078-6. French.

family: Dugravier

full_name: R. Dugravier

given: R.

journal_name: Archives de Pédiatrie

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: L’enfant hospitalisé et la théorie de l’attachement

ReferenceCitation: Guedeney A, Guedeney N, Tereno S, Dugravier R, Greacen T, Welniarz B, Saias T, Tubach F; CAPEDP Study Group. Infant rhythms versus parental time: promoting parent-infant synchrony. J Physiol Paris. 2011 Dec;105(4-6):195-200. doi: 10.1016/j.jphysparis.2011.07.005. Epub 2011 Jul 12. Review.

family: Guedeney

full_name: Antoine Guedeney

given: Antoine

full_name: Nicole Guedeney

given: Nicole

family: Tereno

full_name: Susana Tereno

given: Susana

full_name: Romain Dugravier

given: Romain

family: Greacen

full_name: Tim Greacen

given: Tim

family: Welniarz

full_name: Bertrand Welniarz

given: Bertrand

family: Saias

full_name: Thomas Saias

given: Thomas

family: Tubach

full_name: Florence Tubach

given: Florence

bso_classification: Biology (fond.)

journal_name: Journal of Physiology-Paris

title: Infant rhythms versus parental time: Promoting parent–infant synchrony

ReferenceCitation: Saïas T, Lerner E, Greacen T, Simon-Vernier E, Emer A, Pintaux E, Guédeney A, Dugravier R, Tereno S, Falissard B, Tubach F; CAPEDP Study Group, Revah-Levy A. Evaluating fidelity in home-visiting programs a qualitative analysis of 1058 home visit case notes from 105 families. PLoS One. 2012;7(5):e36915. doi: 10.1371/journal.pone.0036915. Epub 2012 May 18.

family: Saïas

full_name: Thomas Saïas

family: Lerner

full_name: Emilie Lerner

given: Emilie

family: Simon-Vernier

full_name: Elodie Simon-Vernier

given: Elodie

family: Emer

full_name: Alessandra Emer

given: Alessandra

family: Pintaux

full_name: Eléonore Pintaux

given: Eléonore

family: Guédeney

full_name: Antoine Guédeney

family: Falissard

title: Evaluating Fidelity in Home-Visiting Programs a Qualitative Analysis of 1058 Home Visit Case Notes from 105 Families

ReferenceCitation: Greacen T, Welniarz B, Purper-Ouakil D, Wendland J, Dugravier R, Saïas T, Tereno S, Tubach F, Haddad A, Guedeney A; CAPEDP STUDY GROUP. BEST PRACTICE IN INDIVIDUAL SUPERVISION OF PSYCHOLOGISTS WORKING IN THE FRENCH CAPEDP PREVENTIVE PERINATAL HOME-VISITING PROGRAM: RESULTS OF A DELPHI CONSENSUS PROCESS. Infant Ment Health J. 2017 Mar;38(2):267-275. doi: 10.1002/imhj.21630. Epub 2017 Feb 25.

name: EPS de Ville Evrard; Neuilly sur Marne; France

name: Institut de psychologie; Université Paris Descartes; Paris

name: AP-HP, Hôpital Bichat, Unité de Recherche Clinique Paris Nord, Département d'Epidémiologie et Recherche Clinique; INSERM CIC-EC 1425; Paris

name: Université Paris Diderot; Sorbonne Paris Cité; UMR 1123, Paris

name: Former head of 19th arrondissement Child & Adolescent Paris Mental Health Services; Paris

name: Hôpital Bichat Claude Bernard APHP; Université Paris Diderot, Sorbonne Paris Cité; Paris

ReferenceCitation: Dugravier R, Tubach F, Saias T, Guedeney N, Pasquet B, Purper-Ouakil D, Tereno S, Welniarz B, Matos J; CAPEDP Study Group, Guedeney A, Greacen T. Impact of a manualized multifocal perinatal home-visiting program using psychologists on postnatal depression: the CAPEDP randomized controlled trial. PLoS One. 2013 Aug 19;8(8):e72216. doi: 10.1371/journal.pone.0072216. eCollection 2013.

title: Impact of a Manualized Multifocal Perinatal Home-Visiting Program Using Psychologists on Postnatal Depression: The CAPEDP Randomized Controlled Trial

ReferenceCitation: Tubach F, Greacen T, Saïas T, Dugravier R, Guedeney N, Ravaud P, Tereno S, Tremblay R, Falissard B, Guedeney A; CAPEDP Study Group. A home-visiting intervention targeting determinants of infant mental health: the study protocol for the CAPEDP randomized controlled trial in France. BMC Public Health. 2012 Aug 13;12:648. doi: 10.1186/1471-2458-12-648.

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

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


type: Other Identifier

title: Remédiation Orthophonique couplée à Une Prise en Charge Proprioceptive de la Dyslexie. Etude Comparative randomisée

acronym: Pro-Pho-Dys

summary:
To show the interest of the association of proprioceptive and orthophonic care of dyslexic children. The assumption is that proprioceptive support by correcting a centrally located spatial localization instability restores the ability to automate.

It allows a gain of effectiveness of the orthophonic remediation of the reading of dyslexic children.

Interventional comparative study over 9 months, of three modes of care: Speech-language, or proprioceptive, or combined (speech therapy or proprioceptive)

status: Active, not recruiting

ReferenceCitation: Quercia P, Quercia M, Feiss LJ, Allaert F. The distinctive vertical heterophoria of dyslexics. Clin Ophthalmol. 2015 Sep 25;9:1785-97. doi: 10.2147/OPTH.S88497. eCollection 2015.

family: Quercia

full_name: Patrick Quercia

given: Patrick

family: Allaert

full_name: Francois Allaert

given: Francois

full_name: Madeleine Quercia

given: Madeleine

family: Feiss

full_name: Leonard Feiss

given: Leonard

currency_apc_doaj: USD

journal_name: Clinical Ophthalmology

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Scalab CNRS 9193


title: Assessment of Pain During Intramuscular Injection Delay in Adult Psychiatry

acronym: evadoulim

summary: Since psychiatry is still too often confronted with a dichotomy between psyche and soma, the assessment of pain and anxiety at RMI is still rarely done (Willer et al., 1982). The objective of this exploratory study is to evaluate the influence of pharmacological factors (type of injected molecules, injection frequency, injection site, treatment duration, treatment dose, time since last injection) and individual about the pain perceived when injecting antipsychotic therapy (diagnosis, sex, age, weight, duration of illness, level of anxiety, psychiatric and somatic comorbidity, insight). In the future, this study will develop a suitable procedure to limit pain and anxiety during RMI. Taking these dimensions into account will probably allow a better compliance of patients for this type of care, and thus a decrease in the number of relapses in the long term.

ipd_sharing: Undecided

lead_sponsor: Centre hospitalier de Ville-Evrard, France


title: Evaluation of Desensitization Therapy and Re-treatment of Eye Movement Information [EMDR] in Patients With Post-traumatic Stress Disorder [PTSD]: Neuronal Correlates and Cognitive Impact on the Attention and Memory of Emotional Stimuli.

acronym: ICE-EMDR

summary:
This research aims to confirm that the therapeutic effect of EMDR is associated with changes in the interaction between cognitive function and emotional stimuli in PTSD patients compared to a controlled therapy in a randomized, single-blind study.On the other hand, this study aims to observe neuronal and cognitive correlates related to EMDR therapy compared to a control therapy.

This investigation would improve the understanding of the mechanisms of action of the EMDR, still unknown to date.


title: Psychological Outcome of COVID-19 Lockdown on Psychiatric Hospital Staff and Close Relatives (ICOS)

acronym: ICOS

summary: The purpose of the investigators is to study the psychological impact of the COVID-19 lockdown on the members of the Ville Evrard Hospital staff and their close relatives, and to identify potential lockdown conditions that could increase anxiety, anger and depressive symptoms in this population.


title: Evaluation of a Cognitive Remediation Program for Mood Disorders

acronym: ECO-DBP

summary: Psychotherapeutic management of cognitive disorders in patients suffering from a mood disorder

ipd_sharing: Yes


title: Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia: A Double Blind, Randomized Controlled Study

acronym: TDCSHALLU

summary:
the regions which are assumed to underlie the pathophysiology of schizophrenia, namely hypoactivity at the prefrontal level and pathological hyperactivity of the associative regions of the language located in the left temporoparietal region.

to assess the effuicacy of tDCS on auditory hallucinations we perfor an randomized double blind versus placebo trial. In each arms patients will receive two tDCS sessions a day during two weeks

location_facility: unité de recherche clinique de l'E.P.S de Ville Evrard


title: Validation of a Cognitive Remediation Program for Bipolar Disorders

acronym: ECO-BIP

summary: This study evaluates the effect of a new cognitive remediation program designed for patients suffering from a bipolar disorder, on cognitive functions, psychosocial functioning and neural processes. In this double-blind (patient, outcomes assessor) controlled randomized trial the investigators compare patients receiving the ECo program for bipolar disorders, to patients benefiting from the broadly used cognitive remediation program CRT and to patients receiving supportive psychotherapy. Patients are treated for 3 months and monitored for 9 months.

ReferenceCitation: Altshuler LL, Ventura J, van Gorp WG, Green MF, Theberge DC, Mintz J. Neurocognitive function in clinically stable men with bipolar I disorder or schizophrenia and normal control subjects. Biol Psychiatry. 2004 Oct 15;56(8):560-9.

ReferenceCitation: Deckersbach T, Nierenberg AA, Kessler R, Lund HG, Ametrano RM, Sachs G, Rauch SL, Dougherty D. RESEARCH: Cognitive rehabilitation for bipolar disorder: An open trial for employed patients with residual depressive symptoms. CNS Neurosci Ther. 2010 Oct;16(5):298-307. doi: 10.1111/j.1755-5949.2009.00110.x.

family: Deckersbach

full_name: Thilo Deckersbach

given: Thilo

family: Nierenberg

full_name: Andrew A. Nierenberg

given: Andrew A.

family: Kessler

full_name: Ronald Kessler

given: Ronald

family: Lund

full_name: Hannah G. Lund

given: Hannah G.

family: Ametrano

full_name: Rebecca M. Ametrano

given: Rebecca M.

family: Sachs

full_name: Gary Sachs

given: Gary

family: Rauch

full_name: Scott L. Rauch

given: Scott L.

family: Dougherty

full_name: Darin Dougherty

given: Darin

journal_name: CNS Neuroscience & Therapeutics

oa_host_type: repository

version: acceptedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: RESEARCH: Cognitive Rehabilitation for Bipolar Disorder: An Open Trial for Employed Patients with Residual Depressive Symptoms

ReferenceCitation: Martínez-Arán A, Torrent C, Solé B, Bonnín CM, Rosa AR, Sánchez-Moreno J, Vieta E. Functional remediation for bipolar disorder. Clin Pract Epidemiol Ment Health. 2011;7:112-6. doi: 10.2174/1745017901107010112. Epub 2011 Jun 6.

family: Martínez-Arán

full_name: Anabel Martínez-Arán

given: Anabel

journal_name: Clinical Practice & Epidemiology in Mental Health

oa_colors: green other

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

publisher: Bentham Science Publishers Ltd.

title: Functional Remediation for Bipolar Disorder

location_facility: Unité de Recherche Clinique, EPS Ville Evrard


title: Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects

acronym: FUSION

summary: This study evaluates the stiffness and interface pressures of a new compression system URGOBD001 on healthy subjects, compares with a short stretch bandage and a multi component bandage.

lead_sponsor: Laboratoires URGO


title: Extending the Prerogatives of Colorectal Cancer Screening French Organizations to the Follow-up After Colonoscopy of Patients Aged 50 or More: Pilot Study in the Rhône Administrative Department

acronym: Tempo-colo

summary: France is one of the European countries where the incidence of colorectal cancer is the highest among cancers for both sexes. Fecal occult blood screening has been implemented since 2008. However, this screening excludes high risk people who have a 10 to 30 % risk of developing a CRC during their lifetime. Colonoscopy follow up of these persons is not organized, and it is up to the attending physician to recall the date of the surveillance colonoscopy. This results in a poor compliance with the recommendations by these people. A postal reminder of the surveillance colonoscopies sent by The French screening organizations to the patients should increase adherence to follow-up recommendations. The colorectal cancer screening organizations will collects from the hepatogastroenterologists (HGE) informations on colonoscopies of people more than 50 years old who live in the Rhone. These informations will allow to send a reminder 3 months before the date recommended by the HGE. Participation rate and timeliness will be assessed, as well as the severity of the lesions found. A medico-economic analysis will also be carried out.

primary_purpose: Screening

lead_sponsor: Association pour le Dépistage Organisé des Cancers dans le Rhône


title: Factors Associated With Complications of Cervical Necrotizing Fasciitis

summary:
Cervical necrotizing fasciitis (CNF) is a rare but severe complication of pharyngeal or dental infections. The infection can rapidly descend into the mediastinum and lead to a life-threatening prognosis. Treatment consists of a multidisciplinary approach in intensive care with radiologist and with early and repeated surgical debridement. Anti-inflammatory drugs have been incriminated by authors in the development of necrotizing fasciitis. Recently, a single-center study demonstrated that pharyngeal source of CNF and oral glucocorticoid intake before admission was associated with the occurrence of mediastinitis.

The aim of the study is to assess the incidence and factors associated with CNF complications, in particular mediastinitis. Secondary outcome is to describe patient characteristics, medical and surgical management.

Methods: A retrospective, observational, non-interventional multicentre study is conducted in nine intensive care units in France from January 2005 to December 2016.

lead_sponsor: Hospices Civils de Lyon

location_facility: Intensive Care unit, Edouard Herriot Hospital


title: L-Arginine Treatment for Severe Vascular Fetal Intrauterine Growth Restriction: a Randomized Double Bind Controlled Trial

summary: Although there is a strong rationale to supplement gravid patients suffering intrauterine growth restriction (IUGR) or preeclampsia with Arginine or other nitric oxide donors, evidence in the literature has been inconclusive. The current study was designed to determine whether oral treatment with L-Arginine, a nitric oxide (NO) donor, would enhance birth weight and/or decrease neonatal morbidity in pregnancies with severe vascular intrauterine growth restriction (IUGR).

status: Terminated

ReferenceCitation: Winer N, Branger B, Azria E, Tsatsaris V, Philippe HJ, Rozé JC, Descamps P, Boog G, Cynober L, Darmaun D. L-Arginine treatment for severe vascular fetal intrauterine growth restriction: a randomized double-bind controlled trial. Clin Nutr. 2009 Jun;28(3):243-8. doi: 10.1016/j.clnu.2009.03.007. Epub 2009 Apr 8.

family: Winer

full_name: Norbert Winer

given: Norbert

family: Branger

full_name: Bernard Branger

given: Bernard

family: Azria

full_name: Elie Azria

given: Elie

family: Tsatsaris

full_name: Vassilis Tsatsaris

given: Vassilis

family: Philippe

full_name: Henri-Jean Philippe

given: Henri-Jean

family: Rozé

full_name: Jean Christophe Rozé

given: Jean Christophe

family: Descamps

full_name: Philippe Descamps

given: Philippe

family: Boog

full_name: Georges Boog

given: Georges

family: Cynober

full_name: Luc Cynober

given: Luc

family: Darmaun

full_name: Dominique Darmaun

given: Dominique

journal_name: Clinical Nutrition

title: l-Arginine treatment for severe vascular fetal intrauterine growth restriction: A randomized double-bind controlled trial

lead_sponsor: Nantes University Hospital

intervention_type: Drug


title: Effectiveness of Weight-adjusted Prophylactic Low Molecular Weight Heparin Doses Compared With Lower Fixed Prophylactic Doses to Prevent Venous Thromboembolism in COVID-2019. The Multicenter Randomized Controlled Open-label Trial COVI-DOSE

acronym: COVI-DOSE

summary:
Worldwide observational studies indicate a significant prothrombogenic effect associated with SARS-CoV-2 infection with a high incidence of venous thromboembolism (VTE), notably life-threatening pulmonary embolism.

According to recommendations for acute medical illnesses, all COVID-19 hospitalized patients should be given VTE prophylaxis such as a low molecular weight heparin (LMWH). A standard prophylactic dose (eg. Enoxaparin 4000IU once daily) could be insufficient in obese patients and VTE has been reported in patients treated with a standard prophylactic dose.

In COVID-19 patients, guidelines from several international societies confirm the existence of an hypercoagulability and the importance of thromboprophylaxis but the "optimal dose is unknown" and comparative studies are needed.

In view of these elements, carrying out a trial comparing various therapeutic strategies for the prevention of VTE in hospitalized patients with COVID-19 constitutes a health emergency.

Thus, we hypothesize that an increased prophylactic dose of weight-adjusted LMWH would be greater than a lower prophylactic dose of LMWH to reduce the risk of life-threatening VTE in hospitalized patients. The benefit-risk balance of this increase dose will be carefully evaluated because of bleeding complications favored by possible renal / hepatic dysfunctions, drug interactions or invasive procedures in COVID-19 patients.

This multicenter randomized (1:1) open-label controlled trial will randomize hospitalized adults with COVID-19 infection to weight-adjusted prophylactic dose vs. lower prophylactic dose of LMWH.

ReferenceCitation: Flumignan RL, Tinôco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah ÁN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10:CD013739. doi: 10.1002/14651858.CD013739.

name: Department of Surgery, Division of Vascular and Endovascular Surgery; Universidade Federal de São Paulo; São Paulo Brazil

family: Flumignan

full_name: Ronald LG Flumignan

given: Ronald LG

name: Department of Nursing; State University of Rio Grande do Norte; Natal Brazil

family: Tinôco

full_name: Jéssica Dantas de Sá Tinôco

given: Jéssica Dantas de Sá

family: Pascoal

full_name: Patricia IF Pascoal

given: Patricia IF

family: Areias

full_name: Libnah L Areias

given: Libnah L

family: Cossi

full_name: Marcelly S Cossi

given: Marcelly S

family: Fernandes

full_name: Maria ICD Fernandes

given: Maria ICD

name: Department of Nursing; Federal University of Rio Grande do Norte; Natal Brazil

family: Costa

full_name: Isabelle KF Costa

given: Isabelle KF

name: Department of Public Health; State University of Rio Grande do Norte; Natal Brazil

family: Souza

full_name: Larissa Souza

given: Larissa

name: Department of Internal Medicine; American University of Beirut Medical Center; Beirut Lebanon

family: Matar

full_name: Charbel F Matar

given: Charbel F

name: Living Guidelines Program, Cochrane Australia; Melbourne Australia

family: Tendal

full_name: Britta Tendal

given: Britta

name: Medicina de Urgência and Rheumatology; Escola Paulista de Medicina, Universidade Federal de São Paulo and Universidade de Santo Amaro; São Paulo Brazil

family: Trevisani

full_name: Virginia FM Trevisani

given: Virginia FM

name: Cochrane Brazil; Centro de Estudos de Saúde Baseada em Evidências e Avaliação Tecnológica em Saúde; São Paulo Brazil

family: Atallah

full_name: Álvaro N Atallah

given: Álvaro N

family: Nakano

full_name: Luis CU Nakano

given: Luis CU

journal_name: Cochrane Database of Systematic Reviews

lead_sponsor: Central Hospital, Nancy, France

location_facility:
George Pompidou European Hospital
Dijon Academic Hospital
Montpellier Academic Hospital
Besançon Academic Hospital
Groupe Hospitalier Unéos
Lariboisière Academic Hospital
Lille Academic Hospital
Brest Academic Hospital
Amiens Academic Hospital
Civil Hospital
Kremlin Bicêtre Academic Hospital
Emile Muller Hospital
St Etienne Academic Hospital
Toulouse Academic Hospital
Strasbourg Academic Hospital
Nancy Academic Hospital
Metz-Thionville Regional Hospital


title: Comparison of the Prosthesis Ugytex by the Trans-obturator Approach and Anterior Colporrhaphy for the Surgical Treatment of Anterior Vaginal Wall Prolapse

summary:
Hypothesis / aims of study A RCT has shown that results of prolapse repair via vaginal approach could be improved when a polypropylene mesh is used as tissue support (1). However, non protected heavy-weight meshes were associated with a high rate of local complications such as vaginal erosions and dyspareunia (2). The aim of this multicentre study is to evaluate anatomical and functional results of an innovative low-weight polypropylene mesh protected by an absorbable hydrophilic film in the prolapse repair by vaginal route, in comparison by the standard anterior colporrhaphy.

Study design, materials and methods This study involves 15 centres in French Private or Public Hospital. Patients will be randomly allocated to be operated by a standard anterior colporrhaphy or by an anterior repair reinforced by a specially designed mesh: UgytexTM (Sofradim, France). Ugytex is a low-weight (38g/m²) and highly porous (average porosity: 89%, pores over 1.5mm) polypropylene monofilament mesh offering tissue ingrowth and connective differentiation for a stable and long-term support. The mesh is coated with a hydrophilic film composed of atelocollagen, polyethylene glycol and glycerol. The absorbable coating protects delicate pelvic viscera from the risk of acute inflammation during the healing's inflammatory peak. Prolapse severity will be evaluated using the POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the PFIQ questionnaires will be used preoperatively and during follow-up (3), as well as a validated questionnaire on sexual problems. The difference on one-year cure rate should be 15% (80% for the anterior colporrhaphy and 95% for the mesh repair). Then the estimated number of patient is 97 in each arm.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Contribution of a Hand-held Gamma Camera (TreCam) to the SNOLL(Occult Breast Lesion Localization Plus Sentinel Node Biopsy) Procedure in Breast Cancer

acronym: TRECAM

summary: In France, breast cancer affects approximately 53,000 new cases per year. The investigators have to take care more and more women with subclinical lesions (nonpalpable), and it represents around 25% to 35% of the diagnosed breast cancers. The main problem of the surgical management of these lesions is the quality of preoperative identification which determines the quality of surgery and oncological and cosmetic outcomes. For this type of lesion, SNOLL (Sentinel Node and Occult Lesion Localization) procedure could be proposed. This is a radioactive labeling of the tumor site and sentinel lymph node (SLN). The investigators want to evaluate the potential benefits of using a hand held camera called TreCam in this SNOLL procedure. This camera permits to obtain nuclear imaging at the bedside and in the operating theater.

ReferenceCitation: Barranger E, Uzan S, Pitre S, Duval MA, Charon Y. [Development of a hand-held gamma camera (POCI) in the sentinel node biopsy for breast cancer]. Pathol Biol (Paris). 2008 Jul;56(5):254-6. doi: 10.1016/j.patbio.2007.09.009. Epub 2008 Feb 21. French.

ReferenceCitation: Medina-Franco H, Abarca-Pérez L, García-Alvarez MN, Ulloa-Gómez JL, Romero-Trejo C, Sepúlveda-Méndez J. Radioguided occult lesion localization (ROLL) versus wire-guided lumpectomy for non-palpable breast lesions: a randomized prospective evaluation. J Surg Oncol. 2008 Feb 1;97(2):108-11. doi: 10.1002/jso.20880.

ReferenceCitation: Lavoué V, Nos C, Clough KB, Baghaie F, Zerbib E, Poulet B, Lefrère Belda MA, Ducellier A, Lecuru F. Simplified technique of radioguided occult lesion localization (ROLL) plus sentinel lymph node biopsy (SNOLL) in breast carcinoma. Ann Surg Oncol. 2008 Sep;15(9):2556-61. doi: 10.1245/s10434-008-9994-y. Epub 2008 Jun 24.

ReferenceCitation: Monti S, Galimberti V, Trifiro G, De Cicco C, Peradze N, Brenelli F, Fernandez-Rodriguez J, Rotmensz N, Latronico A, Berrettini A, Mauri M, Machado L, Luini A, Paganelli G. Occult breast lesion localization plus sentinel node biopsy (SNOLL): experience with 959 patients at the European Institute of Oncology. Ann Surg Oncol. 2007 Oct;14(10):2928-31. Epub 2007 Aug 1.

ReferenceCitation: Kerrou K, Pitre S, Coutant C, Rouzier R, Ancel PY, Lebeaux C, Huchet V, Montravers F, Pascal O, Duval MA, Lefebvre F, Menard L, Uzan S, Charon Y, Barranger E. The usefulness of a preoperative compact imager, a hand-held gamma-camera for breast cancer sentinel node biopsy: final results of a prospective double-blind, clinical study. J Nucl Med. 2011 Sep;52(9):1346-53. doi: 10.2967/jnumed.111.090464. Epub 2011 Aug 17.

ReferenceCitation: Bricou A, Duval MA, Charon Y, Barranger E. Mobile gamma cameras in breast cancer care - a review. Eur J Surg Oncol. 2013 May;39(5):409-16. doi: 10.1016/j.ejso.2013.02.008. Epub 2013 Mar 7. Review.

ReferenceCitation: The Tumor Resection Camera (TReCam), a multipixel imaging probe for radio-guided surgery.E. Netter, L. Pinot, L. Ménard, M.-A. Duval, B. Janvier, F. Lefebvre, R. Siebert, Y. Charon. Nuclear Science Symposium Conference Record (NSS/MIC), 2009 IEEE, 2573-2576

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Optimized Phase III Trial of Immuno-stimulation With Maraviroc, a CCR5 (Chemokine Receptor 5) Antagonist, Combined With Anti Retroviral Therapy in Advanced, Late Diagnosed HIV-1 Infected Patients With an AIDS-defining Event and/or CD4 (Cluster of Differentiation 4) Counts Below 200 Cells/mm³. ANRS 146 OPTIMAL

acronym: OPTIMAL

summary:
The objective of the OPTIMAL study is to demonstrate that the adjunction of Maraviroc to a combination of antiretroviral therapy in naive and late diagnosed HIV-1 infected patients counts may accelerate the kinetics of immune restoration and decrease the risk of disease progression and death.

It is a randomized, versus placebo, double-blind trial, conducted in France, Spain and Italy.

ReferenceCitation: Lévy Y, Lelièvre JD, Assoumou L, Aznar E, Pulido F, Tambussi G, Crespo M, Meybeck A, Molina JM, Delaugerre C, Izopet J, Peytavin G, Cardon F, Diallo A, Lancar R, Béniguel L, Costagliola D. Addition of Maraviroc Versus Placebo to Standard Antiretroviral Therapy for Initial Treatment of Advanced HIV Infection: A Randomized Trial. Ann Intern Med. 2020 Mar 3;172(5):297-305. doi: 10.7326/M19-2133. Epub 2020 Feb 11.

name: Vaccine Research Institute, Institut National de la Santé et de la Recherche médicale (INSERM), and Assistance Publique Hôpitaux de Paris (APHP), Hôpital H. Mondor, Créteil, France (Y.L., J.L.)

family: Lévy

full_name: Yves Lévy

given: Yves

family: Lelièvre

full_name: Jean-Daniel Lelièvre

given: Jean-Daniel

name: INSERM, Sorbonne Université, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP), Paris, France (L.A., R.L., L.B., D.C.)

family: Assoumou

full_name: Lambert Assoumou

given: Lambert

name: Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica - Grupo de Estudio del SIDA, Madrid, Spain (E.A.)

family: Aznar

full_name: Esther Aznar

given: Esther

name: Hospital Universitario 12 de Octubre, imas12, Universidad Complutense de Madrid (UCM), Madrid, Spain (F.P.)

family: Pulido

full_name: Federico Pulido

given: Federico

name: Istituto di ricovero e cura a carattere scientifico-Ospedale San Raffaele, Milano, Italy (G.T.)

family: Tambussi

full_name: Giuseppe Tambussi

given: Giuseppe

name: Hospital universitario Vall d'Hebron, Barcelona, Spain (M.C.)

family: Crespo

full_name: Manuel Crespo

given: Manuel

name: Service Universitaire des Maladies Infectieuses et du Voyageur, Centre Hospitalier de Tourcoing, Tourcoing, France (A.M.)

family: Meybeck

full_name: Agnès Meybeck

given: Agnès

name: INSERM U944, Université de Paris, Hôpital Saint-Louis, APHP, Paris, France (J.M., C.D.)

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Delaugerre

full_name: Constance Delaugerre

given: Constance

name: INSERM, U1043, Université Toulouse III Paul-Sabatier, Faculté de Médecine Toulouse-Purpan, Toulouse, France (J.I.)

family: Izopet

full_name: Jacques Izopet

given: Jacques

name: Université Paris Diderot, Sorbonne Paris Cité, Laboratoire de Pharmacologie-Toxicologie, Hôpital Bichat-Claude Bernard, APHP, Paris, France (G.P.)

family: Peytavin

full_name: Gilles Peytavin

given: Gilles

name: ANRS, France Recherche Nord & Sud Sida-hiv Hépatites, Agence autonome de l'INSERM, Paris, France (F.C., A.D.)

family: Cardon

full_name: Fanny Cardon

given: Fanny

family: Diallo

full_name: Alpha Diallo

given: Alpha

family: Lancar

full_name: Rémi Lancar

given: Rémi

family: Béniguel

full_name: Lydie Béniguel

given: Lydie

family: Costagliola

full_name: Dominique Costagliola

journal_name: Annals of Internal Medicine

publisher: American College of Physicians

publisher_dissemination: American College of Physicians

publisher_group: American College of Physicians

publisher_normalized: American College of Physicians

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Study of the Kinetics of Microparticles Under Chemotherapy in Patients With Gastric or Pancreatic Cancer

acronym: DOMICA

summary:
Microparticles have recently emerged as a thrombotic risk marker with a potential role in determining which patients are at greatest risk for developing thrombosis. Available data show an increase in the level of microparticles in cancer patients who are undergoing chemotherapy for solid tumors with a possible link to their thrombogenic state.

Our study focuses on the kinetics of microparticles under chemotherapy in patients with pancreatic or gastric cancer by serial measurements of microparticles procoagulant activity.

Detailed Description:

The impact of chemotherapy on microparticles expression will be assessed by measuring their procoagulant activity on blood samples taken during the course of chemotherapy. The thrombotic risk will be evaluated by the score of Khorana in parallel. Microparticles expression in patients with thrombosis will be compared to that in other patients.

primary_purpose: Basic Science

lead_sponsor: Poitiers University Hospital

intervention_type: Procedure


title: Medico-Economic Comparison of Four Strategies of Radioiodine Ablation in Thyroid Carcinoma Patients - Estimabl

acronym: Estimabl

summary:
In France, 3,700 new cases of thyroid cancer are diagnosed each year. Differentiated thyroid carcinoma represents more than 90% of all thyroid cancers; and has a 10-year survival of 90-95% of patients. This favorable prognosis is the result of an effective primary therapy, which consists of a total thyroidectomy that is followed by radio-iodine ablation with 3,7GBq (100mCi) in case of significant risk of persistent disease. Few centers investigated the possibility to administer lower doses of 131I (1GBq, 30 mCi), in order to limit the potential long-term adverse complications for patients and to respond to radioprotection rules for family members and medical staff.

Radio-iodine ablation requires TSH stimulation, which was historically achieved by thyroid hormone withdrawal for 3 to 5 weeks. During this period, patients suffered from symptoms of hypothyroidism. The recombinant human TSH (rhTSH, Thyrogen®, Genzyme Therapeutics, Cambridge, USA) was approved in Europe in 2005 as an alternative stimulation procedure to withdrawal during ablation. It allows patients to remain euthyroid on thyroid hormone therapy (that needs not to be withdrawn). However, this a costly drug (800 € per patient), whose economic efficiency needs to be checked.

ReferenceCitation: Schlumberger M, Leboulleux S, Catargi B, Deandreis D, Zerdoud S, Bardet S, Rusu D, Godbert Y, Buffet C, Schvartz C, Vera P, Morel O, Benisvy D, Bournaud C, Toubert ME, Kelly A, Benhamou E, Borget I. Outcome after ablation in patients with low-risk thyroid cancer (ESTIMABL1): 5-year follow-up results of a randomised, phase 3, equivalence trial. Lancet Diabetes Endocrinol. 2018 Aug;6(8):618-626. doi: 10.1016/S2213-8587(18)30113-X. Epub 2018 May 26.

family: Schlumberger

full_name: Martin Schlumberger

given: Martin

family: Leboulleux

full_name: Sophie Leboulleux

given: Sophie

family: Catargi

full_name: Bogdan Catargi

given: Bogdan

family: Deandreis

full_name: Desiree Deandreis

given: Desiree

family: Zerdoud

full_name: Slimane Zerdoud

given: Slimane

family: Bardet

full_name: Stephane Bardet

given: Stephane

family: Rusu

full_name: Daniela Rusu

given: Daniela

family: Godbert

full_name: Yann Godbert

given: Yann

family: Buffet

full_name: Camille Buffet

given: Camille

family: Schvartz

full_name: Claire Schvartz

given: Claire

family: Vera

full_name: Pierre Vera

given: Pierre

family: Morel

full_name: Olivier Morel

given: Olivier

family: Benisvy

full_name: Danielle Benisvy

given: Danielle

family: Bournaud

full_name: Claire Bournaud

family: Toubert

full_name: Marie-Elisabeth Toubert

given: Marie-Elisabeth

family: Kelly

full_name: Antony Kelly

given: Antony

family: Benhamou

full_name: Ellen Benhamou

given: Ellen

family: Borget

full_name: Isabelle Borget

given: Isabelle

journal_name: The Lancet Diabetes & Endocrinology

ReferenceCitation: Schlumberger M, Catargi B, Borget I, Deandreis D, Zerdoud S, Bridji B, Bardet S, Leenhardt L, Bastie D, Schvartz C, Vera P, Morel O, Benisvy D, Bournaud C, Bonichon F, Dejax C, Toubert ME, Leboulleux S, Ricard M, Benhamou E; Tumeurs de la Thyroïde Refractaires Network for the Essai Stimulation Ablation Equivalence Trial. Strategies of radioiodine ablation in patients with low-risk thyroid cancer. N Engl J Med. 2012 May 3;366(18):1663-73. doi: 10.1056/NEJMoa1108586.

title: Strategies of Radioiodine Ablation in Patients with Low-Risk Thyroid Cancer

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


acronym: ADRIE

summary: The ADRIE study is an observational study on the clinical relevance of platelet reactivity in aspirin and clopidogrel treated cardiovascular patients.

ReferenceCitation: Reny JL, Berdagué P, Poncet A, Barazer I, Nolli S, Fabbro-Peray P, Schved JF, Bounameaux H, Mach F, de Moerloose P, Fontana P; Antiplatelet Drug Resistances and Ischemic Events (ADRIE) Study Group. Antiplatelet drug response status does not predict recurrent ischemic events in stable cardiovascular patients: results of the Antiplatelet Drug Resistances and Ischemic Events study. Circulation. 2012 Jun 26;125(25):3201-10. doi: 10.1161/CIRCULATIONAHA.111.085464. Epub 2012 May 21.

name: From the Division of General Internal Medicine (J.-L.R.), Division of Clinical Epidemiology (A.P.), and Division of Angiology and Haemostasis (S.N., H.B., P.d.M., P.F.), Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland; Division of Internal Medicine (J.-L.R.), Division of Cardiology (P.B.), and Central Laboratories (I.B.), Béziers Hospital, Béziers, France; BESPIM, Nîmes University Hospital, Nîmes, France (P.F.-P.); Hematology Laboratory, Montpellier University Hospital,...

family: Reny

full_name: Jean-Luc Reny

given: Jean-Luc

family: Berdagué

full_name: Philippe Berdagué

given: Philippe

family: Poncet

full_name: Antoine Poncet

given: Antoine

family: Barazer

full_name: Isabelle Barazer

family: Nolli

full_name: Séverine Nolli

given: Séverine

family: Fabbro-Peray

full_name: Pascale Fabbro-Peray

given: Pascale

family: Schved

full_name: Jean-François Schved

given: Jean-François

family: Bounameaux

full_name: Henri Bounameaux

given: Henri

family: Mach

full_name: François Mach

given: François

family: de Moerloose

full_name: Philippe de Moerloose

family: Fontana

full_name: Pierre Fontana

journal_name: Circulation

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Antiplatelet Drug Response Status Does Not Predict Recurrent Ischemic Events in Stable Cardiovascular Patients

ReferenceCitation: Fontana P, James R, Barazer I, Berdagué P, Schved JF, Rebsamen M, Vuilleumier N, Reny JL. Relationship between paraoxonase-1 activity, its Q192R genetic variant and clopidogrel responsiveness in the ADRIE study. J Thromb Haemost. 2011 Aug;9(8):1664-6. doi: 10.1111/j.1538-7836.2011.04409.x.

family: FONTANA

full_name: P. FONTANA

given: P.

family: JAMES

full_name: R. JAMES

given: R.

family: BARAZER

full_name: I. BARAZER

given: I.

family: BERDAGUÉ

full_name: P. BERDAGUÉ

family: SCHVED

full_name: J.-F. SCHVED

family: REBSAMEN

full_name: M. REBSAMEN

given: M.

family: VUILLEUMIER

full_name: N. VUILLEUMIER

given: N.

family: RENY

full_name: J.-L. RENY

journal_name: Journal of Thrombosis and Haemostasis

location_facility: University Hospital Geneva; Beziers and Monpellier University Hospitals, France


title: Etude Comparative Monocentrique, randomisée, en Cross-over, en Double Aveugle, Contre Placebo, de l'Action du méthylphénidate Sur Les paramètres Cognitifs de la Motivation

summary: The purpose of this study is to evaluate the impact of methylphenidate, a mixed dopaminergic and noradrenergic agent, onto the different components of motivation: decision-making, effort allocation and instrumental learning.

study_start_date_type: Anticipated

location_facility: Centre d'investigation clinique, Institut du Cerveau et de la Moelle


title: Effect of Genetic Variants of Intestinal Transporters of Lipophilic Micronutrients (Vitamins D, E and Carotenoids) on Absorption Efficiency of These Compounds.

acronym: VITAGENES

summary: The aim was to identify minor genetic variations (single nucleotide polymorphisms) that explain the interindividual variability in bioavailability of fat soluble micronutrients (fat soluble vitamins and carotenoids).

ReferenceCitation: Borel P. Genetic variations involved in interindividual variability in carotenoid status. Mol Nutr Food Res. 2012 Feb;56(2):228-40. doi: 10.1002/mnfr.201100322. Epub 2011 Sep 29. Review.

ReferenceCitation: Desmarchelier C, Borel P, Goncalves A, Kopec R, Nowicki M, Morange S, Lesavre N, Portugal H, Reboul E. A Combination of Single-Nucleotide Polymorphisms Is Associated with Interindividual Variability in Cholecalciferol Bioavailability in Healthy Men. J Nutr. 2016 Dec;146(12):2421-2428. Epub 2016 Oct 26.

ReferenceCitation: Borel P, Desmarchelier C, Nowicki M, Bott R. A Combination of Single-Nucleotide Polymorphisms Is Associated with Interindividual Variability in Dietary β-Carotene Bioavailability in Healthy Men. J Nutr. 2015 Aug;145(8):1740-7. doi: 10.3945/jn.115.212837. Epub 2015 Jun 10.

name: French National Institute for Agricultural Research, UMR INRA 1260, Marseille, France

name: French National Institute of Health and Medical Research, UMR_S 1062, Marseille, France

name: Aix-Marseille Université, Nutrition, Obesity and Risk of Thrombosis, Marseille, France

family: Borel

full_name: Patrick Borel

given: Patrick

family: Desmarchelier

full_name: Charles Desmarchelier

given: Charles

family: Nowicki

full_name: Marion Nowicki

given: Marion

family: Bott

full_name: Romain Bott

given: Romain

journal_name: The Journal of Nutrition

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Borel P, Desmarchelier C, Nowicki M, Bott R, Morange S, Lesavre N. Interindividual variability of lutein bioavailability in healthy men: characterization, genetic variants involved, and relation with fasting plasma lutein concentration. Am J Clin Nutr. 2014 Jul;100(1):168-75. doi: 10.3945/ajcn.114.085720. Epub 2014 May 7.

family: Morange

full_name: Sophie Morange

given: Sophie

family: Lesavre

full_name: Nathalie Lesavre

given: Nathalie

journal_name: The American Journal of Clinical Nutrition

location_facility: Centre d'Investigation Clinique de l'hôpital de la Conception


title: Pilot Study on Shear-induced Platelet Aggregation in Acute Coronary Syndromes

acronym: REACS

summary: The purpose of this study is to determine whether shear-induced platelet aggregation is able to discriminate first acute coronary syndrome (ACS) from recurrent ACS


title: Osteopenia and Osteoporosis in HIV Infection. Prospective BMD Measurement in Antiretroviral (ARV) Treated and Untreated HIV-1 Infected Patients

summary:
Osteopenia and osteoporosis are increasingly reported in HIV-infected patients, and appear to be more frequent than in general population. However, pathogenesis remains unclear, and published studies still give non concordant results.

We therefore started a prospective study, to assess the potential role of ARV in the occurrence of osteopenia and osteoporosis. BMD evolution over a 2-years period of follow-up, will be compared between patients starting ARV therapy, and subjects without HAART (no indication of treatment). A correlation between BMD and several factors will be looked at (see below).

This study with individual direct benefice, is conducted in 3 outpatients clinics (Strasbourg, Colmar, Mulhouse) in collaboration with the rheumatologic teams. 60 patients are planned to be included over a 3-years inclusion period

lead_sponsor: University Hospital, Strasbourg, France

location_facility:
Centre Hospitalier de Colmar
Hôpitaux Universitaires de Strasbourg
Centre Hospitalier de Mulhouse


title: Non-Interventional, International, Post-Marketing Clinical Follow-up Study on the Stoma Appliance Flexima®/Softima® 3S

acronym: KISSS

summary:
To evaluate the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up.

The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.

lead_sponsor: BBraun Medical SAS

location_facility:
CHU Lapeyronie
Hopital Tenon


type: Registry Identifier

title: Assessment of Circulating Tumor Cells as an Early Predictive Marker of Response to a First Line Treatment Based on an Anti-Human Epidermal Growth Factor Receptor (HER), Cetuximab, in Patients With Inoperable Recurrent and/or Metastatic Head-and-neck Squamous-cell Carcinoma.

acronym: CIRCUTEC

summary: In France, the incidence of head and neck squamous cell carcinomas (HNSCC) is 16 000 new cases/year. During these last years, many new chemotherapies and targeted therapies have been developed improving significantly the overall survival of patients notably anti-HER molecules. In inoperable recurrent and/or metastatic HNSCC, the best treatment is based on an anti-Human Epidermal Growth Factor Receptor (EGFR) antibody, targeting Human Epidermal Growth Factor Receptor 1 (HER1), the Cetuximab combined with platinum +/- 5 Fluoro Uracil (5FU): " Extreme protocol ". However, no clinical or biological criteria predictive of drug efficacy have been reported yet. Thus, the development of such a predictive factor is an urgent need in HNSCC at both the clinical and pharmacy-economic level, to propose the best personalized treatment. One idea would be to enumerate and characterize the circulating tumor cells (CTC) which could give us an early evaluation of the therapeutic efficiency. In this context, the investigators have developed an innovative technology, the EPISPOT assay (patent of the University Medical Center of Montpellier), that allows the detection & characterization of viable CTC in the peripheral blood. The EPISPOT technology has been already evaluated in the breast and prostate cancer.Thus, the investigators would like for the first time to perform a prospective study on a cohort of patients treated following the Extreme protocol, with this technology, to assess the predictive value of CTC count. The investigators will use the CellSearch® system as the reference test.

ReferenceCitation: Garrel R, Mazel M, Perriard F, Vinches M, Cayrefourcq L, Guigay J, Digue L, Aubry K, Alfonsi M, Delord JP, Lallemant B, Even C, Daurès JP, Landais P, Cupissol D, Alix-Panabières C. Circulating Tumor Cells as a Prognostic Factor in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: The CIRCUTEC Prospective Study. Clin Chem. 2019 Oct;65(10):1267-1275. doi: 10.1373/clinchem.2019.305904. Epub 2019 Aug 6.

name: Department of Head Neck Cancer and Laryngology, University Medical Center of Montpellier, Montpellier, France

family: Garrel

full_name: Renaud Garrel

given: Renaud

name: Laboratory of Rare Human Circulating Cells (LCCRH), University Medical Center of Montpellier, Montpellier, France

family: Mazel

full_name: Martine Mazel

given: Martine

name: Department of Biostatistics, UPRES EA2415, Clinical Research University Institute, Montpellier, France

family: Perriard

full_name: Françoise Perriard

given: Françoise

name: Medical Oncology Department, Institute of Cancer of Montpellier, Montpellier, France

family: Vinches

full_name: Marie Vinches

given: Marie

family: Cayrefourcq

full_name: Laure Cayrefourcq

given: Laure

name: Medical Oncology Department, Antoine Lacassagne Cancer Research Center, Nice, France

family: Guigay

full_name: Joël Guigay

given: Joël

name: Department of Medical Oncology, University Medical Center of Bordeaux University Hospital-CHU Bordeaux, Bordeaux, France

family: Digue

full_name: Laurence Digue

given: Laurence

name: Department of Head and Neck Surgery, University Hospital Center of Limoges, Limoges, France

family: Aubry

full_name: Karine Aubry

given: Karine

name: Department of Radiation Oncology, Clinique Sainte Catherine, Avignon, France

family: Alfonsi

full_name: Marc Alfonsi

given: Marc

name: Medical Oncology Department, Claudius Regaud Institute Oncopole, Toulouse, France

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

name: Department of Head and Neck Surgery, University Hospital Center of Nîmes, Nîmes, France

family: Lallemant

full_name: Benjamin Lallemant

given: Benjamin

name: Department of Head and Neck Oncology, Gustave Roussy Cancer Campus, Villejuif, France

family: Even

full_name: Caroline Even

given: Caroline

family: Daurès

full_name: Jean-Pierre Daurès

family: Landais

full_name: Paul Landais

given: Paul

family: Cupissol

full_name: Didier Cupissol

given: Didier

family: Alix-Panabières

full_name: Catherine Alix-Panabières

given: Catherine

journal_name: Clinical Chemistry

evidence: open (via free article)

ReferenceCitation: Le Louedec F, Alix-Panabières C, Lafont T, Allal BC, Garrel R, Digue L, Guigay J, Cupissol D, Delord JP, Lallemant B, Alfonsi M, Aubry K, Mazel M, Becher F, Perriard F, Chatelut E, Thomas F. Cetuximab pharmacokinetic/pharmacodynamics relationships in advanced head and neck carcinoma patients. Br J Clin Pharmacol. 2019 Jun;85(6):1357-1366. doi: 10.1111/bcp.13907. Epub 2019 Apr 13.

name: Laboratory of PharmacologyInstitut Claudius Regaud, IUCT‐Oncopole Toulouse France

name: CRCTUniversity of Toulouse, Inserm Toulouse France

family: Le Louedec

full_name: Félicien Le Louedec

given: Félicien

name: Laboratory of Rare Human Circulating CellsUniversity Medical Centre of Montpellier Montpellier France

family: Alix‐Panabières

full_name: Catherine Alix‐Panabières

family: Lafont

full_name: Thierry Lafont

given: Thierry

family: Allal

name: Department of Head Neck Cancer and LaryngologyUniversity Medical Centre of Montpellier France

name: Medical Oncology DepartmentCHU Saint André Bordeaux France

name: Department of Head and Neck OncologyGustave Roussy Villejuif France

name: Department of Medical Oncology Nice France

name: Medical Oncology DepartmentInstitute of Cancer of Montpellier France

name: Medical Oncology DepartmentInstitut Claudius Regaud, IUCT‐Oncopole Toulouse France

name: Department of Head and Neck SurgeryUniversity Hospital Center of Nîmes France

name: Department of Radiation OncologyClinique Sainte Catherine Avignon France

name: Department of Head and Neck Oncology and SurgeryHôpital Dupuytren CHU Limoges France

name: Service de Pharmacologie et Immunoanalyse, Laboratoire d'Etude du Métabolisme des Médicaments, Commissariat à l'Énergie Atomique et aux Énergies Alternatives, Institut National de la Recherche AgronomiqueUniversité Paris Saclay Gif‐sur‐Yvette France

name: Department of Biostatistics, UPRES EA2415Clinical Research University Institute Montpellier France

journal_name: British Journal of Clinical Pharmacology

location_facility: Department of Otorhinolaryngology, CHU Gui de Chauliac


title: Study of Metabolic Changes in the Transformation Malignant Precancerous Skin Lesions

acronym: MITOSKIN

summary: Skin carcinomas are the most frequent cancers in the world, including basal cell carcinomas and cutaneous squamous cell carcinoma (cSCCs), with more than 60.000 new annual cases in France. Their incidence increases mainly due to ultraviolet (UV) exposure and population ageing. Then from 1994 to 2006, the incidence of cSCC has increased by 300%. CSCCs typically manifests as a spectrum from a precursor actinic keratosis (AK) - possible spontaneous regression at this stage- to in situ cSCC invasive cSCC and finally metastatic cSCC.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceCitation: Obre E, Rossignol R. Emerging concepts in bioenergetics and cancer research: metabolic flexibility, coupling, symbiosis, switch, oxidative tumors, metabolic remodeling, signaling and bioenergetic therapy. Int J Biochem Cell Biol. 2015 Feb;59:167-81. doi: 10.1016/j.biocel.2014.12.008. Epub 2014 Dec 24. Review.

ReferenceCitation: Hosseini M, Dousset L, Mahfouf W, Serrano-Sanchez M, Redonnet-Vernhet I, Mesli S, Kasraian Z, Obre E, Bonneu M, Claverol S, Vlaski M, Ivanovic Z, Rachidi W, Douki T, Taieb A, Bouzier-Sore AK, Rossignol R, Rezvani HR. Energy Metabolism Rewiring Precedes UVB-Induced Primary Skin Tumor Formation. Cell Rep. 2018 Jun 19;23(12):3621-3634. doi: 10.1016/j.celrep.2018.05.060.

ReferenceCitation: Hosseini M, Dousset L, Michon P, Mahfouf W, Muzotte E, Bergeron V, Bortolotto D, Rossignol R, Moisan F, Taieb A, Bouzier-Sore AK, Rezvani HR. UVB-induced DHODH upregulation, which is driven by STAT3, is a promising target for chemoprevention and combination therapy of photocarcinogenesis. Oncogenesis. 2019 Sep 24;8(10):52. doi: 10.1038/s41389-019-0161-z.

ReferenceCitation: Mahfouf W, Hosseini M, Muzotte E, Serrano-Sanchez M, Dousset L, Moisan F, Rachidi W, Taieb A, Rudolf J, Rezvani HR. Loss of Epidermal HIF-1α Blocks UVB-Induced Tumorigenesis by Affecting DNA Repair Capacity and Oxidative Stress. J Invest Dermatol. 2019 Sep;139(9):2016-2028.e7. doi: 10.1016/j.jid.2019.01.035. Epub 2019 Mar 13.

lead_sponsor: University Hospital, Bordeaux


ReferenceCitation: Camu W, Lehert P, Pierrot-Deseilligny C, Hautecoeur P, Besserve A, Jean Deleglise AS, Payet M, Thouvenot E, Souberbielle JC. Cholecalciferol in relapsing-remitting MS: A randomized clinical trial (CHOLINE). Neurol Neuroimmunol Neuroinflamm. 2019 Aug 6;6(5). pii: e597. doi: 10.1212/NXI.0000000000000597. Print 2019 Sep. Erratum in: Neurol Neuroimmunol Neuroinflamm. 2019 Nov 15;7(1):.

family: Camu

full_name: William Camu

given: William

family: Lehert

full_name: Philippe Lehert

given: Philippe

family: Pierrot-Deseilligny

full_name: Charles Pierrot-Deseilligny

given: Charles

family: Hautecoeur

full_name: Patrick Hautecoeur

given: Patrick

family: Besserve

full_name: Anne Besserve

given: Anne

family: Jean Deleglise

full_name: Anne-Sophie Jean Deleglise

given: Anne-Sophie

family: Payet

full_name: Marianne Payet

given: Marianne

family: Thouvenot

full_name: Eric Thouvenot

given: Eric

family: Souberbielle

full_name: Jean Claude Souberbielle

given: Jean Claude

journal_name: Neurology - Neuroimmunology Neuroinflammation

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_normalized: University of Melbourne - Minerva Access

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

repository_normalized: HAL

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

intervention_type: Dietary Supplement

lead_sponsor: Merck KGaA, Darmstadt, Germany

acronym: CHOLINE

location_facility: CHU Hôpital Gui de Chauliac Service de Neurologie B

type: EudraCT Number

source: euctr

title: A Multicentre, Randomised, Double-blind, Placebo-controlled Study of the Efficacy of Supplementary Treatment With Cholecalciferol (Vitamin D3) in Patients With Relapsing- Multiple Sclerosis (RMS) Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times Weekly

summary: The aim of this multicentre, randomised, double-blind, placebo-controlled study is to evaluate the efficacy and safety of supplementary treatment with cholecalciferol (vitamin D3) in subjects with relapsing multiple sclerosis (R MS) treated with subcutaneous (s.c.) interferon beta-1a 44 microgram (mcg) [Rebif] 3 times weekly. The subjects will be divided into 2 groups, one receiving cholecalciferol 100,000 IU twice monthly along with Rebif treatment and the other group will be on placebo along with Rebif treatment. A total of 200 subjects will be recruited in 20-30 centres in France.


title: Intervention Research for Suicide Prevention Among Adolescents and Young Adults in the General Population Using E-health Tools and a Promotion System Involving the Civilian Population

acronym: E-psYouth

summary:
"France's suicide rate is among the highest in Europe, with the young among the more at risk. Several European projects have demonstrated the effectiveness of using e-tools in suicide prevention particularly for hard-to-reach populations.

Lessons from StopBlues, an e-health tool (application/website) for suicide prevention in the general population developed in 2018 which was promoted by municipalities and general practitioners, show the necessity to adapt its content for young people.

The objective is to develop an e-health tool for suicide prevention targeting adolescents and young adults with psychological pain by adapting StopBlues and its promotional plan.

The detailed content of the e-health tool and its promotional plan will be determined via a literature review followed by individual and group interviews with experts and youth, with StopBlues as a starting part.

This adaptation of StopBlues will allow to reach a larger audience by offering a more suitable solution for this vulnerable population. A web-portal will serve as an entry point for both StopBlues and the new e-tool where users will be redirected to one of the tools/modules according to their profile and respective needs. "

location_facility: ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (URC Eco, Hôpital Hôtel-Dieu)


title: Management of Diabetic Patients With Neuropathic Osteoarthropathy (Charcot Foot) : Descriptive Study in Diabetic-foot Centers.

acronym: EPiChar

summary: Despite the prominence of diabetes prevalence (more than 8% of the world population in 2012) and its expected increase in the next 15 years, Charcot foot remains a widely unknown diabetes complication. At this day, there is no national guidelines about diagnosis and treatment of this complication, which is known to alter life quality and to increase risk of foot ulceration and mortality in diabetics. Through this descriptive multicentric study, we will investigate the Charcot foot cares in diabetic-foot centers in France and Belgium.

location_facility: CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi


title: Time Prediction for Complete Recovery From Neuromuscular Blockade After Visual Recovery With Double Burst Stimulation

acronym: DBS PREDICTION

summary: The purpose is to calculate the time for an optimal recovery (T4/T1 > 0.9) from the moment when 2 responses to double burst stimulation are visually identical and this for 95% of patients.


title: Sensitivity and Specificity of the Modified Helicobacter Test INFAI Using New Test Meal With Urea Breath Test in Helicobacter Pylori Positive and Negative Patients With Dyspepsia and GERD Taking Proton Pump Inhibitors

summary:
Study to confirm the sensitivity of the C^13-UBT using the new test meal for H. Pylori in patients with dyspepsia and GERD taking PPI

Secondary objectives : to compare the sensitivity and specificity of the C^13-UBT using the new test meal and standard test meal for H.Pylori in patients with dyspepsia and GERD taking PPI.

to complete the results of the Helicbacter test INFAI using new test meal for H.Pylori in patients with dyspepsia and GERD taking PPI with :

Histology score for H.Pylori in antrum an corpus using the updated Sydney System
Sex,
Age,
Body Mass Index (BMI)

status: Withdrawn


summary: Oxytocin is a neurohypophysial hormone involved in several central and peripheral functions including parturition, milk let-down reflex and social behaviour. In vitro and animals studies have shown growing evidence that oxytocin plays a role in bone remodeling and osteoporosis. The investigators have previously show in a small sample of post-menopausal women with severe osteoporosis (n=20) compare to healthy control (n=16) that oxytocin serum level is significantly decreased, independently of leptin and estradiol, that are known to modulate oxytocin secretion. Thus, oxytocin appears as a new interesting factor in the osteoporosis pathophysiology. The aim of the present study is to confirm the relationships between bone status, evaluated by bone mineral density and prevalent fragility fractures, body composition and oxytocin serum levels on a large population. The investigators will also determine if the relationship between bone mineral density and oxytocin is independent of estradiol and leptin in this population and evaluate the relationships between oxytocin serum level and co-morbidities such as cardiovascular diseases, depression and dementia. Theses analysis will be done on the serum already available of 1000 women of the international OPUS cohort. Bone mineral density, body composition analysis by Dual energy X-ray Absorptiometry (DXA), estradiol and clinical data are already available. The investigators will select women, aged from 55 to 79 y at the time of inclusion.

ReferenceCitation: Breuil V, Fontas E, Chapurlat R, Panaia-Ferrari P, Yahia HB, Faure S, Euller-Ziegler L, Amri EZ, Szulc P. Oxytocin and bone status in men: analysis of the MINOS cohort. Osteoporos Int. 2015 Dec;26(12):2877-82. doi: 10.1007/s00198-015-3201-3. Epub 2015 Jun 25.

family: Breuil

full_name: V. Breuil

given: V.

family: Fontas

full_name: E. Fontas

given: E.

family: Chapurlat

full_name: R. Chapurlat

given: R.

family: Panaia-Ferrari

full_name: P. Panaia-Ferrari

given: P.

family: Yahia

full_name: H. B. Yahia

given: H. B.

family: Faure

full_name: S. Faure

given: S.

family: Euller-Ziegler

full_name: L. Euller-Ziegler

given: L.

family: Amri

full_name: E. Z. Amri

given: E. Z.

family: Szulc

full_name: P. Szulc

journal_name: Osteoporosis International

ReferenceCitation: Breuil V, Panaia-Ferrari P, Fontas E, Roux C, Kolta S, Eastell R, Ben Yahia H, Faure S, Gossiel F, Benhamou CL, Euller-Ziegler L, Amri EZ. Oxytocin, a new determinant of bone mineral density in post-menopausal women: analysis of the OPUS cohort. J Clin Endocrinol Metab. 2014 Apr;99(4):E634-41. doi: 10.1210/jc.2013-4126. Epub 2014 Jan 21.

name: Department of Rheumatology (V.B., H.B.Y., L.E.-Z.), Nice F-06003, France;

name: Nice University Hospital, Archet Hospital, Faculté de Médecine (V.B., L.E.-Z., E.-Z.A.), Nice F-06003, France;

full_name: Véronique Breuil

given: Véronique

name: University Nice Sophia Antipolis, Department of Hormonolgy (P.P.-F., H.B.Y., S.F.), Nice F-06003, France;

full_name: Patricia Panaia-Ferrari

given: Patricia

name: Nice University Hospital, St Roch Hospital, and Department of Clinical Research (E.F.), Nice University Hospital, Cimiez Hospital, Nice F-06003, France;

full_name: Eric Fontas

name: Department of Rheumatology (C.R., S.K.), INSERM, Unité 1153, Paris Descartes University, Cochin Hospital, F-75014 Paris, France;

family: Roux

full_name: Christian Roux

given: Christian

family: Kolta

full_name: Sami Kolta

given: Sami

name: Academic Unit of Bone Metabolism (R.E., F.G.), University of Sheffield, Sheffield S10 2JF, United Kingdom;

family: Eastell

full_name: Richard Eastell

given: Richard

name: Centre National de la Recherche Scientifique (H.B.Y., E.-Z.A.), Institut de Biologie Valrose Unité Mixte de Recherche 7277, F-06100 Nice, France;

name: INSERM (H.B.Y., E.-Z.A.), iBV, Unité 1091, F-06100 Nice, France;

family: Ben Yahia

full_name: Hedi Ben Yahia

given: Hedi

full_name: Sylvie Faure

given: Sylvie

family: Gossiel

full_name: Fatma Gossiel

given: Fatma

name: INSERM (C.-L.B.), Unité 658, Centre Hospitalier Régional d'Orléans, F-45032 Orléans Cedex 1, France

family: Benhamou

full_name: Claude-Laurent Benhamou

given: Claude-Laurent

full_name: Liana Euller-Ziegler

given: Liana

full_name: Ez-Zoubir Amri

given: Ez-Zoubir

journal_name: The Journal of Clinical Endocrinology & Metabolism

title: Oxytocin, a New Determinant of Bone Mineral Density in Post-Menopausal Women: Analysis of the OPUS Cohort

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Multicentric Study for the Validation and Improvement of a Structured Report Tool for the Imaging Characterization of Bone Tumors - Bone Tumor Imaging Report and Data System (BTI-RADS)

acronym: BTI-RADS M

summary: In this study a previously described structured multimodality image report system for the characterization of focal bone lesions is evaluated in a larger patient population. The objective of this study is to evaluate the performance of this tool stratifying the malignancy risk of bone tumors.

ReferenceCitation: Ribeiro GJ, Gillet R, Hossu G, Trinh JM, Euxibie E, Sirveaux F, Blum A, Teixeira PAG. Solitary bone tumor imaging reporting and data system (BTI-RADS): initial assessment of a systematic imaging evaluation and comprehensive reporting method. Eur Radiol. 2021 Oct;31(10):7637-7652. doi: 10.1007/s00330-021-07745-9. Epub 2021 Mar 25.

family: Ribeiro

full_name: Guilherme Jaquet Ribeiro

given: Guilherme Jaquet

family: Gillet

full_name: Romain Gillet

given: Romain

family: Hossu

full_name: Gabriela Hossu

given: Gabriela

family: Trinh

full_name: Jean-Michel Trinh

given: Jean-Michel

family: Euxibie

full_name: Eve Euxibie

given: Eve

family: Sirveaux

full_name: François Sirveaux

given: François

family: Blum

full_name: Alain Blum

given: Alain

family: Teixeira

full_name: Pedro Augusto Gondim Teixeira

given: Pedro Augusto Gondim

journal_name: European Radiology

location_facility: Groupement des Hopitaux de l'institut catholique de Lille

location_facility: Université Lyon 1 - Centre Hospitalier Lyon-Sud

location_facility: Hôpital Universitaire Paris Centre site Cochin APHP

intervention_type: Diagnostic Test


title: Covid-19 Vaccine Cohort in Specific Populations

acronym: COV-POPART

summary: Multicentre national cohort study with prospective data collection and biological specimen collection.

location_facility:
Nîmes CHU
Cmg-Ec U1219
Paris Cochin APHP


title: COrticosteroids in acUte uRticAria in emerGency dEpartment

acronym: COURAGE

summary: To demonstrate the non-inferiority of the efficacy of a single antihistamine in comparaison with an association of antihistamine and corticosteroid in the treatment of acute urticaria in emergency departments

ReferenceCitation: Javaud N, Soria A, Maignan M, Martin L, Descamps V, Fain O, Bouillet L, Berard F, Tazarourte K, Roy PM, Fontaine JP, Bagot M, Khellaf M, Goulet H, Lapostolle F, Casalino E, Doutre MS, Gil-Jardine C, Caux F, Chosidow O, Pateron D, Vicaut E, Adnet F. Glucocorticoids for acute urticaria: study protocol for a double-blind non-inferiority randomised controlled trial. BMJ Open. 2019 Aug 21;9(8):e027431. doi: 10.1136/bmjopen-2018-027431.

family: Javaud

full_name: Nicolas Javaud

given: Nicolas

family: Soria

full_name: Angele Soria

given: Angele

family: Maignan

full_name: Maxime Maignan

given: Maxime

family: Martin

full_name: Ludovic Martin

given: Ludovic

family: Descamps

full_name: Vincent Descamps

given: Vincent

family: Fain

full_name: Olivier Fain

given: Olivier

family: Bouillet

full_name: Laurence Bouillet

given: Laurence

family: Berard

full_name: Frederic Berard

given: Frederic

family: Tazarourte

full_name: Karim Tazarourte

given: Karim

family: Roy

full_name: Pierre-Marie Roy

given: Pierre-Marie

family: Fontaine

full_name: Jean-Paul Fontaine

given: Jean-Paul

family: Bagot

full_name: Martine Bagot

given: Martine

family: Khellaf

full_name: Mehdi Khellaf

given: Mehdi

family: Goulet

full_name: Helene Goulet

given: Helene

family: Lapostolle

full_name: Frederic Lapostolle

family: Casalino

full_name: Enrique Casalino

given: Enrique

family: Doutre

full_name: Marie-Sylvie Doutre

given: Marie-Sylvie

family: Gil-Jardine

full_name: Cedric Gil-Jardine

given: Cedric

family: Caux

full_name: Frederic Caux

family: Chosidow

full_name: Olivier Chosidow

family: Pateron

full_name: Dominique Pateron

given: Dominique

family: Vicaut

full_name: Eric Vicaut

given: Eric

family: Adnet

full_name: Frederic Adnet


title: Epidemiologic Study on Small-for-gestational-age Children (EPIPAGE2 Cohort Study) - Follow up at Five and a Half Years

summary:
Epipage 2 (epidemiologic study on small-for-gestational-age children) is a nationwide study implemented to improve our knowledge of the outcome of preterm children in France. This study was launched on March 28, 2011 and includes three groups of preterm children, all born before 35 weeks: extremely preterm infants (born between 22 and 26 completed weeks of gestation), very preterm children (born between 27 and 31 completed weeks) and moderately preterm children (born between 32 and 34 completed weeks).

These children are being studied from their birth up to the age of 12 years. At birth, data on maternal and infants' characteristics were collected from medical records. At one and two years, questionnaires sent to families and to physicians (at two years only) allowed to collect data about the children's life and health.

At five and a half years, medical and psychological assessments are specifically implemented for the study in order to evaluate motor and cognitive disorders in this population.

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

location_facility: Hôpital Saint Vincent de Paul - Groupement des Hôpitaux de l'Institut Catholique de Lille

location_facility: Hôpital Bel Air Thionville - CHR Metz Thionville


title: Interscalene Block on Ventilatory Function After Shoulder Surgery : Evaluation of Single or Continuous Injection

acronym: KTBIS

summary: Interscalene block with local anesthetic impairs ventilation (unilateral diaphragmatic dysfunction). Single injection of local anesthetic induced transitory dysfunction (< 24h). The investigators hypothesized that continuous interscalene block would prolonged ventilatory impairment

lead_sponsor: Pierre and Marie Curie University


title: Diagnostic Value and Prognostic Value of the Blood Level Determination of S100 Protein in Minor or Mild Traumatic Brain Injury (GCS Glasgow Score 9 to 15).

summary:
Traumatic brain injury (TBI) is a Public Health problem, because of the numbers of events (more than 200,000 per year in France). Craniocerebral tomodensitometry (CCT) is widely used for the diagnosis of minor/mild TBI, but both the access to the CCT and the cost of this imagery are critical factors. We hypothesized that the blood level measurement of S100 protein (S100), a neurological biomarker of cerebral injury, would help to the clinical evaluation of minor/mild head injury events, and would be an economic alternative to CCT for the diagnosis of these pathologies. In addition, a part of the study will explore the prognostic value of such blood level S100 determination for the evaluation of medical/social consequences of minor/mild TBI.

Medical objective of the study:

to assess the contribution of early determination (to medical care) of S100 for the diagnosis of minor/moderate TBI (TCCMM - Glasgow sup or equal to 9),
to determine the usefulness of a second dosage three hours later for the medical decision.

In other words, to compare S100 biomarker and CCT considered as a reference ( "Gold Standard") for the diagnosis or exclusion of TCCMM, and to precise its terms of use.

Economic objective:

to conduct a cost-effectiveness study of blood level determination of S100 vs. CCT for the diagnosis of minor/moderate TBI and its medical/social consequences

time_perspective: Cross-Sectional

location_facility: Groupe Hospitalier Pitié-Salpêtrière - Charles Foix


title: Target Attainment of TDM-guided Continuous Infusion of Piperacillin/Tazobactam and Cefepim in Critically Ill Patients: a Prospective Observational Study

acronym: DOSATB

summary:
Although alternative dosing strategies can improve antimicrobial exposure in critically ill patients, the high PK variability in this population means that some may still receive sub-optimal antibiotic exposure leading to unfavourable clinical outcomes.

Therapeutic drug management (TDM) guided dosing is the only safe and effective way to ensure that all critically ill patients achieve therapeutic antimicrobial exposures and to minimise the likelihood of toxicity.

For experts, TDM should be a standard of care, in particular for β-lactams. Nevertheless, because of the assay method for β-lactams and the need for bioanalytical experts, delays in obtaining results frequently occurred. These barriers, combined with difficulties in the interpretation of TDM results, need to be addressed in order to increase its routine utilization. Consequently, study aiming at identify which subgroup of patients or infection are more likely to benefit from TDM are urgently warranted This prospective observational study aimed at evaluating target attainment of piperacillin/tazobactam (PIP/TAZ) and cefepim (CEF) with the use of a Therapeutic Drug Monitoring (TDM) in critically patients during the routine care

location_facility:
Emmanuel NOVY
Central Hospital


title: Interstitial Pneumonia With Autoimmune Features: Evaluation of Connective Tissue Disease Incidence During Follow-up

acronym: EVOLIPAF

summary: Interstitial lung diseases (ILD) represent a frequent complication of connective tissue diseases (CTDs), especially systemic sclerosis, idiopathic inflammatory myopathies and rheumatoid arthritis. ILD can either occur during CTD course or be the first manifestation of CTDs. Therefore screening patients with ILD for CTD is crucial. In some cases, ILD are associated with clinical and/or serological autoimmune features but not classifiable for CTDs. Evolution of these forms to defined CTDs has never been study. Recently, the European Respiratory Society/American Thoracic Society experts proposed a new term, "interstitial pneumonia with autoimmune features" or IPAF, to describe these patients according to updated classification criteria. Aims of this study were to compare CTD occurence during follow-up between IPAF and non-IPAF patients in a idiopathic interstitial pneumonia cohort and to identify risk factors of CTD progression in IPAF patients at diagnosis.

ReferenceCitation: Steen VD, Medsger TA. Changes in causes of death in systemic sclerosis, 1972-2002. Ann Rheum Dis. 2007 Jul;66(7):940-4. Epub 2007 Feb 28.

ReferenceCitation: Fathi M, Dastmalchi M, Rasmussen E, Lundberg IE, Tornling G. Interstitial lung disease, a common manifestation of newly diagnosed polymyositis and dermatomyositis. Ann Rheum Dis. 2004 Mar;63(3):297-301.

ReferenceCitation: Tanaka N, Kim JS, Newell JD, Brown KK, Cool CD, Meehan R, Emoto T, Matsumoto T, Lynch DA. Rheumatoid arthritis-related lung diseases: CT findings. Radiology. 2004 Jul;232(1):81-91. Epub 2004 May 27.

ReferenceCitation: Keane MP, Lynch JP 3rd. Pleuropulmonary manifestations of systemic lupus erythematosus. Thorax. 2000 Feb;55(2):159-66. Review.

ReferenceCitation: Tillie-Leblond I, Wislez M, Valeyre D, Crestani B, Rabbat A, Israel-Biet D, Humbert M, Couderc LJ, Wallaert B, Cadranel J. Interstitial lung disease and anti-Jo-1 antibodies: difference between acute and gradual onset. Thorax. 2008 Jan;63(1):53-9. Epub 2007 Jun 8.

ReferenceCitation: Kinder BW, Collard HR, Koth L, Daikh DI, Wolters PJ, Elicker B, Jones KD, King TE Jr. Idiopathic nonspecific interstitial pneumonia: lung manifestation of undifferentiated connective tissue disease? Am J Respir Crit Care Med. 2007 Oct 1;176(7):691-7. Epub 2007 Jun 7.

ReferenceCitation: Vij R, Noth I, Strek ME. Autoimmune-featured interstitial lung disease: a distinct entity. Chest. 2011 Nov;140(5):1292-1299. doi: 10.1378/chest.10-2662. Epub 2011 May 12.

ReferenceCitation: Fischer A, West SG, Swigris JJ, Brown KK, du Bois RM. Connective tissue disease-associated interstitial lung disease: a call for clarification. Chest. 2010 Aug;138(2):251-6. doi: 10.1378/chest.10-0194.

ReferenceCitation: Fischer A, Antoniou KM, Brown KK, Cadranel J, Corte TJ, du Bois RM, Lee JS, Leslie KO, Lynch DA, Matteson EL, Mosca M, Noth I, Richeldi L, Strek ME, Swigris JJ, Wells AU, West SG, Collard HR, Cottin V; "ERS/ATS Task Force on Undifferentiated Forms of CTD-ILD". An official European Respiratory Society/American Thoracic Society research statement: interstitial pneumonia with autoimmune features. Eur Respir J. 2015 Oct;46(4):976-87. doi: 10.1183/13993003.00150-2015. Epub 2015 Jul 9.


title: Genetics and Genomics of Hypertension Associated With Microinflammation, Oxydative Stress, Chronic Renal Disease and Heart Failure (A2-B2-B3)

acronym: Hypercare

summary: This project aims at investigating the genetic, genomic and proteomic basis of hypertension and susceptibility to hypertension-related end organ damage (renal damage and heart failure). It will include cross sectional as well as follow-up studies with a large number of subjects and variety of phenotypes, to explore the pathophysiology of hypertension and hypertension-related disease.

location_facility: Centre D'Investigation Clinique de Strasbourg


title: Effects of Osteopathic Treatment in the Management of Care-induced Pain in Elderly Care, in Follow-up Care and Rehabilitation Geriatric

acronym: OGéDIS

summary:
The purpose of this study is to evaluate effects of Osteopathic Treatment in the Management of Care-induced pain in Elderly care, in Follow-up care and Rehabilitation Geriatric.

The investigators assume that the application of a procedure based on osteopathic fascial techniques in elderly care in Suite and Geriatric Rehabilitation ( SSRG ) suffering from pain of nursing care, could reduce the painful phenomenon having systemic action, and improve tissue engineering, trophicity viscera and the neurovascular supply .

lead_sponsor: Centre Hospitalier René Dubos