title: Participation in Screening for Cervical Cancer: Interest of a Human Papillomavirus (HPV) Self-sampling Device Provided by the General Practitioner; a Cluster Randomized Clinical Trial

acronym: PaCUDAHL-Gé

summary: This study evaluates the benefit in women aged from 30 to 65 years, who do not participate to the French opportunistic cervical cancer screening program, of an organized screening with the proposition by the family physician of a pap-test (usual care) versus a self-collected vaginal sample (and a HPV-test). 24 family physicians will participate and will be randomized in the usual care arm (12) or in the self-sampling arm (12). Our hypothesis is that organizing the screening for these women involving their family physician will major participation, and that the self-sampling option will amplify this increase.

ReferenceCitation: Fishbein M. A reasoned action approach to health promotion. Med Decis Making. 2008 Nov-Dec;28(6):834-44. doi: 10.1177/0272989X08326092. Epub 2008 Nov 17.

ReferenceCitation: van Baars R, Bosgraaf RP, ter Harmsel BW, Melchers WJ, Quint WG, Bekkers RL. Dry storage and transport of a cervicovaginal self-sample by use of the Evalyn Brush, providing reliable human papillomavirus detection combined with comfort for women. J Clin Microbiol. 2012 Dec;50(12):3937-43. doi: 10.1128/JCM.01506-12. Epub 2012 Sep 26.

ReferenceCitation: Viguier J, Calazel-Benque A, Eisinger F, Pivot X. Organized colorectal cancer screening programmes: how to optimize efficiency among general practitioners. Eur J Cancer Prev. 2011 Jan;20 Suppl 1:S26-32. doi: 10.1097/01.cej.0000391567.49006.af.

ReferenceCitation: Verhoef VM, Bosgraaf RP, van Kemenade FJ, Rozendaal L, Heideman DA, Hesselink AT, Bekkers RL, Steenbergen RD, Massuger LF, Melchers WJ, Bulten J, Overbeek LI, Berkhof J, Snijders PJ, Meijer CJ. Triage by methylation-marker testing versus cytology in women who test HPV-positive on self-collected cervicovaginal specimens (PROHTECT-3): a randomised controlled non-inferiority trial. Lancet Oncol. 2014 Mar;15(3):315-22. doi: 10.1016/S1470-2045(14)70019-1. Epub 2014 Feb 13.

ReferenceCitation: Duport N, Serra D, Goulard H, Bloch J. [Which factors influence screening practices for female cancer in France?]. Rev Epidemiol Sante Publique. 2008 Oct;56(5):303-13. doi: 10.1016/j.respe.2008.07.086. Epub 2008 Oct 31. French.

ReferenceCitation: Anhang R, Nelson JA, Telerant R, Chiasson MA, Wright TC Jr. Acceptability of self-collection of specimens for HPV DNA testing in an urban population. J Womens Health (Larchmt). 2005 Oct;14(8):721-8.

ReferenceCitation: Haguenoer K, Giraudeau B, Gaudy-Graffin C, de Pinieux I, Dubois F, Trignol-Viguier N, Viguier J, Marret H, Goudeau A. Accuracy of dry vaginal self-sampling for detecting high-risk human papillomavirus infection in cervical cancer screening: a cross-sectional study. Gynecol Oncol. 2014 Aug;134(2):302-8. doi: 10.1016/j.ygyno.2014.05.026. Epub 2014 Jun 3.

family: Haguenoer

full_name: K. Haguenoer

given: K.

family: Giraudeau

full_name: B. Giraudeau

given: B.

family: Gaudy-Graffin

full_name: C. Gaudy-Graffin

given: C.

family: de Pinieux

full_name: I. de Pinieux

given: I.

family: Dubois

full_name: F. Dubois

given: F.

family: Trignol-Viguier

full_name: N. Trignol-Viguier

given: N.

family: Viguier

full_name: J. Viguier

given: J.

family: Marret

full_name: H. Marret

given: H.

family: Goudeau

full_name: A. Goudeau

given: A.

journal_name: Gynecologic Oncology

title: Accuracy of dry vaginal self-sampling for detecting high-risk human papillomavirus infection in cervical cancer screening: A cross-sectional study

ReferenceCitation: Cadman L, Ashdown-Barr L, Waller J, Szarewski A. Attitudes towards cytology and human papillomavirus self-sample collection for cervical screening among Hindu women in London, UK: a mixed methods study. J Fam Plann Reprod Health Care. 2015 Jan;41(1):38-47. doi: 10.1136/jfprhc-2013-100705. Epub 2014 Feb 12.

apc_source: openAPC

family: Cadman

full_name: Louise Cadman

given: Louise

family: Ashdown-Barr

full_name: Lesley Ashdown-Barr

given: Lesley

family: Waller

full_name: Jo Waller

given: Jo

family: Szarewski

full_name: Anne Szarewski

given: Anne

journal_name: Journal of Family Planning and Reproductive Health Care

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: Queen Mary University of London - Queen Mary Research Online

repository_institution: University College London - UCL Discovery

repositories_institution: Queen Mary University of London - Queen Mary Research Online

repositories_institution: University College London - UCL Discovery

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Waller J, Bartoszek M, Marlow L, Wardle J. Barriers to cervical cancer screening attendance in England: a population-based survey. J Med Screen. 2009;16(4):199-204. doi: 10.1258/jms.2009.009073.

name: Cancer Research UK Health Behaviour Research Centre, Department of Epidemiology and Public Health, UCL, London, UK

ReferenceCitation: Cox JT, Castle PE, Behrens CM, Sharma A, Wright TC Jr, Cuzick J; Athena HPV Study Group. Comparison of cervical cancer screening strategies incorporating different combinations of cytology, HPV testing, and genotyping for HPV 16/18: results from the ATHENA HPV study. Am J Obstet Gynecol. 2013 Mar;208(3):184.e1-184.e11. doi: 10.1016/j.ajog.2012.11.020. Epub 2012 Nov 19.

journal_name: American Journal of Obstetrics and Gynecology

ReferenceCitation: Park Y, Lee E, Choi J, Jeong S, Kim HS. Comparison of the Abbott RealTime High-Risk Human Papillomavirus (HPV), Roche Cobas HPV, and Hybrid Capture 2 assays to direct sequencing and genotyping of HPV DNA. J Clin Microbiol. 2012 Jul;50(7):2359-65. doi: 10.1128/JCM.00337-12. Epub 2012 Apr 18.

name: Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea

name: Green Cross Reference Laboratory, Yong In, Kyunggi-do, Republic of Korea

title: Comparison of the Abbott RealTi m e High-Risk Human Papillomavirus (HPV), Roche Cobas HPV, and Hybrid Capture 2 Assays to Direct Sequencing and Genotyping of HPV DNA

ReferenceCitation: TOMBOLA Group. Cytological surveillance compared with immediate referral for colposcopy in management of women with low grade cervical abnormalities: multicentre randomised controlled trial. BMJ. 2009 Jul 28;339:b2546. doi: 10.1136/bmj.b2546.

ReferenceCitation: Rigal L, Saurel-Cubizolles MJ, Falcoff H, Bouyer J, Ringa V. Do social inequalities in cervical cancer screening persist among patients who use primary care? The Paris Prevention in General Practice survey. Prev Med. 2011 Sep;53(3):199-202. doi: 10.1016/j.ypmed.2011.06.016. Epub 2011 Jun 25.

ReferenceCitation: Chan Chee C, Begassat M, Kovess V. [Factors associated with cervical cancer screening in women covered by national health insurance]. Rev Epidemiol Sante Publique. 2005 Feb;53(1):69-75. French.

ReferenceCitation: Zehbe I, Moeller H, Severini A, Weaver B, Escott N, Bell C, Crawford S, Bannon D, Paavola N. Feasibility of self-sampling and human papillomavirus testing for cervical cancer screening in First Nation women from Northwest Ontario, Canada: a pilot study. BMJ Open. 2011 Feb 26;1(1):e000030. doi: 10.1136/bmjopen-2010-000030.

ReferenceCitation: Goodman A. HPV testing as a screen for cervical cancer. BMJ. 2015 Jun 30;350:h2372. doi: 10.1136/bmj.h2372. Review.

title: HPV testing as a screen for cervical cancer

ReferenceCitation: Gök M, Heideman DA, van Kemenade FJ, Berkhof J, Rozendaal L, Spruyt JW, Voorhorst F, Beliën JA, Babovic M, Snijders PJ, Meijer CJ. HPV testing on self collected cervicovaginal lavage specimens as screening method for women who do not attend cervical screening: cohort study. BMJ. 2010 Mar 11;340:c1040. doi: 10.1136/bmj.c1040. Erratum in: BMJ. 2016 May 18;353:i2823.

ReferenceCitation: Broberg G, Gyrd-Hansen D, Miao Jonasson J, Ryd ML, Holtenman M, Milsom I, Strander B. Increasing participation in cervical cancer screening: offering a HPV self-test to long-term non-attendees as part of RACOMIP, a Swedish randomized controlled trial. Int J Cancer. 2014 May 1;134(9):2223-30. doi: 10.1002/ijc.28545. Epub 2013 Oct 31.

name: The Regional Cancer Centre; Western Health Care Region; Gothenburg Sweden

name: The Department of Obstetrics and Gynaecology; Institute of Clinical Science, The Sahlgrenska Academy at the University of Gothenburg; Gothenburg Sweden

name: COHERE, University of Southern Denmark; Odense Denmark

name: The Department of Public Health and Community Medicine; University of Gothenburg; Gothenburg Sweden

title: Increasing participation in cervical cancer screening: Offering a HPV self-test to long-term non-attendees as part of RACOMIP, a Swedish randomized controlled trial

ReferenceCitation: Grillo F, Vallée J, Chauvin P. Inequalities in cervical cancer screening for women with or without a regular consulting in primary care for gynaecological health, in Paris, France. Prev Med. 2012 Mar-Apr;54(3-4):259-65. doi: 10.1016/j.ypmed.2012.01.013. Epub 2012 Jan 24.

ReferenceCitation: Elfström KM, Smelov V, Johansson AL, Eklund C, Nauclér P, Arnheim-Dahlström L, Dillner J. Long term duration of protective effect for HPV negative women: follow-up of primary HPV screening randomised controlled trial. BMJ. 2014 Jan 16;348:g130. doi: 10.1136/bmj.g130.

ReferenceCitation: Gök M, Heideman DA, van Kemenade FJ, de Vries AL, Berkhof J, Rozendaal L, Beliën JA, Overbeek L, Babović M, Snijders PJ, Meijer CJ. Offering self-sampling for human papillomavirus testing to non-attendees of the cervical screening programme: Characteristics of the responders. Eur J Cancer. 2012 Aug;48(12):1799-808. doi: 10.1016/j.ejca.2011.11.022. Epub 2011 Dec 13.

ReferenceCitation: Bulk S, Bulkmans NW, Berkhof J, Rozendaal L, Boeke AJ, Verheijen RH, Snijders PJ, Meijer CJ. Risk of high-grade cervical intra-epithelial neoplasia based on cytology and high-risk HPV testing at baseline and at 6-months. Int J Cancer. 2007 Jul 15;121(2):361-7. Erratum in: Int J Cancer. 2007 Oct 15;121(8):1873.

ReferenceCitation: Lazcano-Ponce E, Lorincz AT, Cruz-Valdez A, Salmerón J, Uribe P, Velasco-Mondragón E, Nevarez PH, Acosta RD, Hernández-Avila M. Self-collection of vaginal specimens for human papillomavirus testing in cervical cancer prevention (MARCH): a community-based randomised controlled trial. Lancet. 2011 Nov 26;378(9806):1868-73. doi: 10.1016/S0140-6736(11)61522-5. Epub 2011 Nov 1.

ReferenceCitation: Cullen J, Schwartz MD, Lawrence WF, Selby JV, Mandelblatt JS. Short-term impact of cancer prevention and screening activities on quality of life. J Clin Oncol. 2004 Mar 1;22(5):943-52. Review.

ReferenceCitation: C Kitchener H, Canfell K, Gilham C, Sargent A, Roberts C, Desai M, Peto J. The clinical effectiveness and cost-effectiveness of primary human papillomavirus cervical screening in England: extended follow-up of the ARTISTIC randomised trial cohort through three screening rounds. Health Technol Assess. 2014 Apr;18(23):1-196. doi: 10.3310/hta18230.

name: Institute of Cancer Sciences, University of Manchester, Manchester, UK

name: Lowy Cancer Research Centre, Prince of Wales Clinical School, University of New South Wales, Sydney, NSW, Australia

name: Non-Communicable Disease Epidemiology Unit, London School of Hygiene and Tropical Medicine, London, UK

name: Department of Virology, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK

name: Institute of Population Health, University of Manchester, Manchester, UK

name: Manchester Cytology Centre, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

repositories_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

ReferenceCitation: Giorgi Rossi P, Marsili LM, Camilloni L, Iossa A, Lattanzi A, Sani C, Di Pierro C, Grazzini G, Angeloni C, Capparucci P, Pellegrini A, Schiboni ML, Sperati A, Confortini M, Bellanova C, D'Addetta A, Mania E, Visioli CB, Sereno E, Carozzi F; Self-Sampling Study Working Group. The effect of self-sampled HPV testing on participation to cervical cancer screening in Italy: a randomised controlled trial (ISRCTN96071600). Br J Cancer. 2011 Jan 18;104(2):248-54. doi: 10.1038/sj.bjc.6606040. Epub 2010 Dec 21.

ReferenceCitation: Favre J, Rochoy M, Raginel T, Pelletier M, Messaadi N, Deken-Delannoy V, Duhamel A, Berkhout C. The Effect of Cervical Smears Performed by General Practitioners on the Cervical Cancer Screening Rate of their Female Patients: A Claim Database Analysis and Cross-Sectional Survey. J Womens Health (Larchmt). 2018 Jul;27(7):933-938. doi: 10.1089/jwh.2017.6656. Epub 2018 Mar 27.

name: Department of General Practice/Family Medicine, School of Medicine, Lille University, Lille, France.

name: Normandie Univ, UCBN, INSERM U1086, Cancers & Preventions, CHU de Caen, Caen, France.

name: Department of General Medicine, UCBN, Medical School, Normandie Univ, Caen, France.

name: Department of Public Health, Lille Univ. EA 2694, University Hospital Lille, Lille, France.

ReferenceCitation: Rochoy M, Raginel T, Favre J, Soueres E, Messaadi N, Deken V, Duhamel A, Berkhout C. Factors associated with the achievement of cervical smears by general practitioners. BMC Res Notes. 2017 Dec 8;10(1):723. doi: 10.1186/s13104-017-2999-5.

repository_institution: Université de Lille (University Of Lille) - LillOA

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

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

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

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

repositories_institution: Université de Lille (University Of Lille) - LillOA


type: Registry Identifier

title: Effect of the Type of Maternal Pushing During the Second Stage of Labor on Obstetric and Neonatal Outcome: a Multicenter Randomized Trial

acronym: EOLE

summary: The objective of this randomized clinical trial is to assess and compare the effectiveness of directed closed-glottis (Valsalva) pushing (pushing while holding one's breath) vs. directed open-glottis pushing (pushing during a prolonged exhalation) during the second stage of labor. The study hypothesis is that open-glottis pushing results in better maternal and neonatal outcomes, in particular for maternal pelvic floor and continence function.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Barasinski C, Vendittelli F. Effect of the type of maternal pushing during the second stage of labour on obstetric and neonatal outcome: a multicentre randomised trial-the EOLE study protocol. BMJ Open. 2016 Dec 20;6(12):e012290. doi: 10.1136/bmjopen-2016-012290.

family: Barasinski

full_name: Chloé Barasinski

given: Chloé

sequence: first

family: Vendittelli

full_name: Françoise Vendittelli

given: Françoise

sequence: additional

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Effect of the type of maternal pushing during the second stage of labour on obstetric and neonatal outcome: a multicentre randomised trial—the EOLE study protocol

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


type: EudraCT Number

title: Opioid System Cerebral Activity in Endurance Sportswomen - Addiction or Denutrition ? [11C]Diprenorphine PET Study

summary:
Abnormal opioid system have been identified in addictive behavior and activity of the opioid system has also shown a strong link with the nutritional balance. A significant increase in endorphin levels was noticed after exercise, proportional to the duration and intensity of this activity. One brain imaging study showed an increase in opioid activity in athletes after endurance training. However , a decrease in opioid tone related to receptor desensitization in the brain has been raised in the sport and it is possible to feel like , the subject must perform physical exercise more frequently . Consequently, in order to deepen the hypothesis of addiction in high-level sport , the brain opioid activity should be assessed pre- training compared to a group of sedentary control subjects .

Preliminary results of a previous study the investigators are conducting on anorexia nervosa (AN ) show abnormalities that appear to be involved in self addiction anorexia nervosa and the regulation of gonadal function. However, the relation of cause and effect between these anomalies and undernutrition remains to be determined . Given the addictive component in the endurance sport and the variability of the nutritional status of its practitioners , evaluation of brain activity in these subjects could provide additional answers.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service d'Endocrinologie - CHU Saint-Etienne

intervention_type: Other


title: Evaluation of Local Anesthesia Before Arterial Puncture for Blood Gas Analysis Randomized, Control Placebo Study

acronym: GAEL

summary: The aim of the study is to evaluate the interest of Local Anesthesia (lidocaïne/prilocaïne versus placebo)before arterial puncture for Blood Gas Analysis. The pain is measured with a numeric Pain Intensity for all patients included.

ReferenceCitation: Beaumont M, Goret M, Orione C, Fauche A, Nowak E, Dion A, Darnois V, Tromeur C, Cogulet V, Leroyer C, Couturaud F, Le Mao R. Effect of Local Anesthesia on Pain During Arterial Puncture: The GAEL Randomized Placebo-Controlled Trial. Respir Care. 2021 Jun;66(6):976-982. doi: 10.4187/respcare.08328. Epub 2021 Mar 23.

family: Beaumont

full_name: Marc Beaumont

given: Marc

family: Goret

full_name: Marion Goret

given: Marion

family: Orione

full_name: Charles Orione

given: Charles

family: Fauche

full_name: Alexandre Fauche

given: Alexandre

family: Nowak

full_name: Emmanel Nowak

given: Emmanel

family: Dion

full_name: Angelina Dion

given: Angelina

family: Darnois

full_name: Veronique Darnois

given: Veronique

family: Tromeur

full_name: Cecile Tromeur

given: Cecile

family: Cogulet

full_name: Virginie Cogulet

given: Virginie

family: Leroyer

full_name: Christophe Leroyer

given: Christophe

family: Couturaud

full_name: Francis Couturaud

given: Francis

family: Le Mao

full_name: Raphael Le Mao

given: Raphael

journal_name: Respiratory Care

publisher: Daedalus Enterprises

publisher_dissemination: Daedalus Enterprises

publisher_group: Daedalus Enterprises

publisher_normalized: Daedalus Enterprises

lead_sponsor: University Hospital, Brest

intervention_type: Drug


title: Renal Denervation in Patients With Resistant Hypertension

acronym: DENER-HTN

summary: The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the effectiveness and costs of renal denervation in addition to standardized medical treatment compared to medical treatment alone in subjects with resistant hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.

ReferenceCitation: Hamdidouche I, Gosse P, Cremer A, Lorthioir A, Delsart P, Courand PY, Denolle T, Halimi JM, Girerd X, Ormezzano O, Rossignol P, Pereira H, Azizi M; DENERHTN Investigators. Clinic Versus Ambulatory Blood Pressure in Resistant Hypertension: Impact of Antihypertensive Medication Nonadherence: A Post Hoc Analysis the DENERHTN Study. Hypertension. 2019 Nov;74(5):1096-1103. doi: 10.1161/HYPERTENSIONAHA.119.13520. Epub 2019 Sep 23.

name: From the INSERM, Centre d’Investigations Cliniques- Plurithématique 1418, Paris, France (I.H., H.P., M.A.)

family: Hamdidouche

full_name: Idir Hamdidouche

given: Idir

name: ESH Hypertension excellence center, Hopital Saint André, University hospital of Bordeaux, France (P.G., A.C.)

family: Gosse

full_name: Philippe Gosse

given: Philippe

family: Cremer

full_name: Antoine Cremer

given: Antoine

name: AP-HP, Hypertension unit and DMU CARTE, Hôpital Européen Georges-Pompidou, Paris, France (A.L., H.P., M.A.)

family: Lorthioir

full_name: Aurelien Lorthioir

given: Aurelien

name: CHU Lille, Institut Cœur Poumon, Bd Pr Leclercq, France (P.D.)

family: Delsart

full_name: Pascal Delsart

given: Pascal

name: Cardiology department, European Society of Hypertension Excellence Center, Hôpital de la Croix-Rousse et Hôpital Lyon Sud, Hospices Civils de Lyon, France (P.-Y.C.)

name: Université de Lyon, CREATIS; CNRS UMR5220; INSERM U1044; INSA-Lyon; Université Claude Bernard Lyon 1, France (P.-Y.C.)

family: Courand

full_name: Pierre-Yves Courand

given: Pierre-Yves

name: Hĉpital Arthur Gardiner, Centre d’Excellence en HTA Rennes- Dinard, France (T.D.)

family: Denolle

full_name: Thierry Denolle

given: Thierry

name: Service de nephrologie-immunologie clinique, Hopital universitaire de Tours, et EA4245 Université Francois Rabelais, France (J.-M.H.)

family: Halimi

full_name: Jean-Michel Halimi

given: Jean-Michel

name: Unité de Prévention Cardio Vasculaire, Groupe Hospitalier Universitaire Pitié-Salpêtrière–Institut IE3M, Paris, France (X.G)

family: Girerd

full_name: Xavier Girerd

given: Xavier

name: Department of Cardiology, University Hospital and INSERM U1039, Bioclinic Radiopharmaceutics Laboratory, Grenoble, France (O.O.)

family: Ormezzano

full_name: Olivier Ormezzano

given: Olivier

name: Université de Lorraine, Inserm, Centre d’Investigations Cliniques- Plurithématique 14-33, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France (P.R.)

family: Rossignol

full_name: Patrick Rossignol

given: Patrick

name: AP-HP Clinical and Epidemiological Unit, Hopital Europeen Georges Pompidou, Paris, France (H.P.).

family: Pereira

full_name: Helena Pereira

given: Helena

name: Université de Paris, Paris, France (M.A.)

family: Azizi

full_name: Michel Azizi

given: Michel

family: Amar

full_name: L Amar

given: L

family: Bobrie

full_name: G Bobrie

given: G

family: Monge

full_name: M Monge

given: M

family: Pagny

full_name: JY Pagny

given: JY

family: Sapoval

full_name: M Sapoval

family: Claisse

full_name: G Claisse

family: Midulla

full_name: M Midulla

family: Mounier-Vehier

full_name: C Mounier-Vehier

given: C

family: Dauphin

full_name: R Dauphin

given: R

family: Fauvel

full_name: JP Fauvel

given: JP

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Courand PY, Pereira H, Del Giudice C, Gosse P, Monge M, Bobrie G, Delsart P, Mounier-Vehier C, Lantelme P, Denolle T, Dourmap C, Halimi JM, Girerd X, Rossignol P, Zannad F, Ormezzano O, Vaisse B, Herpin D, Ribstein J, Bouhanick B, Mourad JJ, Ferrari E, Chatellier G, Sapoval M, Azarine A, Azizi M; DENERHTN Investigators. Abdominal Aortic Calcifications Influences the Systemic and Renal Hemodynamic Response to Renal Denervation in the DENERHTN (Renal Denervation for Hypertension) Trial. J Am Heart Assoc. 2017 Oct 10;6(10). pii: e007062. doi: 10.1161/JAHA.117.007062.

name: Hôpital Croix‐Rousse, Cardiology Department, European Society of Hypertension Excellence Centre, Hospices Civils de Lyon, France

name: CREATIS UMR5220 INSERM U1044 INSA‐Lyon Université de Lyon Université Claude Bernard Lyon 1, Lyon, France

name: Clinical Research Unit, Assistance Publique‐Hôpitaux de Paris Hôpital Européen Georges Pompidou, Paris, France

name: INSERM CIC1418 Assistance Publique‐Hôpitaux de Paris Hôpital Européen Georges Pompidou, Paris, France

name: Vascular and Oncological Interventional Radiology Department, Assistance Publique‐Hôpitaux de Paris Hôpital Européen Georges Pompidou, Paris, France

name: Cardiology/Hypertension Department, Centre Hospitalier Universitaire de Bordeaux Hôpital Saint André, Bordeaux, France

name: Institut Mutualiste Montsouris, Paris, France

name: Hypertension Unit, Assistance Publique‐Hôpitaux de Paris Hôpital Européen Georges Pompidou, Paris, France

name: Hôpital Cardiologique, Médecine Vasculaire et HTA, Centre Hospitalier Régional Universitaire de Lille, France

name: Hôpital Arthur Gardiner, Centre d'excellence en HTA Rennes‐Dinard, Dinard, France

name: Service de Cardiologie et Maladies Vasculaires, Centre Hospitalier Universitaire de Rennes, France

name: Hôpital de la Pitié Salpétrière, Paris, France

name: Inserm Centre d'Investigations Cliniques‐1433 Inserm U1116 CHRU Nancy F‐CRIN INI‐CRCT Université de Lorraine, Nancy, France

name: Cardiology Department, CHU de Poitiers, Poitiers, France

name: Hôpital Arnaud de Villeneuve, Montpellier, France

name: Paris‐Descartes University, Paris, France

journal_name: Journal of the American Heart Association

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

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central
pdfs.semanticscholar.org

ReferenceCitation: Gosse P, Cremer A, Pereira H, Bobrie G, Chatellier G, Chamontin B, Courand PY, Delsart P, Denolle T, Dourmap C, Ferrari E, Girerd X, Michel Halimi J, Herpin D, Lantelme P, Monge M, Mounier-Vehier C, Mourad JJ, Ormezzano O, Ribstein J, Rossignol P, Sapoval M, Vaïsse B, Zannad F, Azizi M. Twenty-Four-Hour Blood Pressure Monitoring to Predict and Assess Impact of Renal Denervation: The DENERHTN Study (Renal Denervation for Hypertension). Hypertension. 2017 Mar;69(3):494-500. doi: 10.1161/HYPERTENSIONAHA.116.08448. Epub 2017 Jan 23.

name: From the Hopital Saint André, University Hospital of Bordeaux, France (P.G., A.C.); Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d’Investigations Cliniques 1418, Paris, France (H.P., G.C., M.A.); Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit, Paris, France (G.B., M.M., M.A.); Paris-Descartes University, Paris, France (G.C., M.A.); Service de médecine Interne et Hypertension artérielle Pole Cardiovasculaire et métabolique,...

ReferenceCitation: Azizi M, Pereira H, Hamdidouche I, Gosse P, Monge M, Bobrie G, Delsart P, Mounier-Véhier C, Courand PY, Lantelme P, Denolle T, Dourmap-Collas C, Girerd X, Michel Halimi J, Zannad F, Ormezzano O, Vaïsse B, Herpin D, Ribstein J, Chamontin B, Mourad JJ, Ferrari E, Plouin PF, Jullien V, Sapoval M, Chatellier G; DENERHTN Investigators. Adherence to Antihypertensive Treatment and the Blood Pressure-Lowering Effects of Renal Denervation in the Renal Denervation for Hypertension (DENERHTN) Trial. Circulation. 2016 Sep 20;134(12):847-57. doi: 10.1161/CIRCULATIONAHA.116.022922. Epub 2016 Aug 30.

name: From Paris-Descartes University, France (M.A., P.-F.P., V.J., M.S., G.C.); Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit, France (M.A., G.B., P.-F.P.); INSERM, CIC1418, Paris, France (M.A., H.P., G.C.); Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Clinical Research Unit, France (H.P., G.C.); Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Department of Pharmacology, France (I.H., V.J.); Centre...

name: Hôpital Européen Georges Pompidou, Paris (31/28)

name: Hôpital de la Croix Rousse and Hôpital Edouard Herriot, Lyon (14/13)

name: Hôpital Saint André and Hôpital Pellegrin, Bordeaux (14/13)

name: Hôpital Arthur Gardiner, Dinard and CHU Rennes (12/12)

name: Hôpital de la Pitié Salpétrière, Paris (6/5)

name: Hôpital Lapeyronie and Hôpital Arnaud de Villeneuve, Montpellier (2/2)

title: Adherence to Antihypertensive Treatment and the Blood Pressure–Lowering Effects of Renal Denervation in the Renal Denervation for Hypertension (DENERHTN) Trial

ReferenceCitation: Azizi M, Sapoval M, Gosse P, Monge M, Bobrie G, Delsart P, Midulla M, Mounier-Véhier C, Courand PY, Lantelme P, Denolle T, Dourmap-Collas C, Trillaud H, Pereira H, Plouin PF, Chatellier G; Renal Denervation for Hypertension (DENERHTN) investigators. Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial. Lancet. 2015 May 16;385(9981):1957-65. doi: 10.1016/S0140-6736(14)61942-5. Epub 2015 Jan 26.

ReferenceCitation: Persu A, Sapoval M, Azizi M, Monge M, Danse E, Hammer F, Renkin J. Renal artery stenosis following renal denervation: a matter of concern. J Hypertens. 2014 Oct;32(10):2101-5. doi: 10.1097/HJH.0000000000000323.


title: Tapering Abatacept or Tocilizumab in Rheumatoid Arthritis in Remission. An Evaluation of Disease Activity, Relapse Risk, Structural Progression and the Economic Impact of a Tapering Strategy

acronym: TOLEDO

summary:
Ever since the biotherapy agents have entered the market, the recommended therapeutic objective in Rheumatoid arthritis, has been remission. Once obtained, it is advised to try to reduce or cease these biotherapy agents, for which, their efficacy is counterbalanced to their tolerance in the medium and long term as well as their high price. Nevertheless, we do not dispose considerable data on the risks of relapse or structural progression during such a step down strategy. A few studies on anti-TNF agents have shown the possibility of such therapy reduction. A national study, " STRASS ", coordinated by Bruno FAUTREL, has evaluated the possibility of spacing or even stopping the injections of anti-TNF(s). To date, no data concerning Abatacept or Tocilizumab has been published.

As the expected result, this study is aimed to test the feasibility of a step down strategy on 2 biological agents, Abatacept and Tocilizumab, in RA patients in remission.

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism)

acronym: MECCORT

summary:
Cholesterol cristal embolization (CCE) is an orphan multisystem vascular condition occurring in elderly with severe atherosclerosis.

In most patients, avoiding the precipitating factors and combination of statin and RAS inhibitor are recommended.

The lack of randomized controlled trial in CCE precludes significant advances. The investigators decided to assess whether prednisone started early, at mild dosage and for a short period prevents death and progression to end-stage renal failure in patients with severe CCE, as compared to placebo.

status: Terminated

lead_sponsor: University Hospital, Toulouse

status_simplified: Unknown


type: Other Identifier

title: Phenotypical Approach of the Drug Metabolizing Hormones Activity (CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4 and P-gp) Before and After Roux-en Y-Gastric Bypass. The SODA Protocol: Surgery for Obesity and Drug Availability

acronym: SODA

summary:
The activity of drug-metabolizing enzymes and transporters evolutes after Roux-en-Y gastric Bypass.

Primary aim : To study the intra individual evolution of phenotypical markers of different drug metabolizing enzymes and one transporter (CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4 and P-gp), using a cocktail phenotypic approach, after Roux-en-Y gastric Bypass.

location_facility: Unit of internal medicine A, Lariboisière Hospital


title: Survey of Patients With Idiopathic Orbital Inflammation Syndrome (IOIS): Clinical, Morphological and Pathological Features and Treatment Outcomes

acronym: SIOI

summary: The purpose of this study is to characterise the clinical features, histopathology and the treatment outcomes of patients with idiopathic orbital inflammation syndrome.

study_type: Observational

time_perspective: Other

location_facility: Service de Médecine interne - Hôpital Avicenne


title: Bedside Genetic Approach to Identify Clopidogrel CYP2C19 Metabolizer and Optimize Maintenance Thienopyridine Treatment After an Acute Coronary Syndrome: The GAMMA Study

acronym: GAMMA

summary: To demonstrate that a strategy of fast genetic testing performed in outpatient clinic allows to select adequately one of the 2 antiplatelet treatments approved in the same indication (ACS with PCI - prasugrel 10mg MD or clopidogrel 75mg MD). Patients will reach similar levels of platelet inhibition with the 2 different thienopyridines suggesting optimal risk/benefit ratio in most patients with individualized therapy.

time_perspective: Prospective

location_facility: ACTION-Institut de Cardiologie-Groupe Hospitalier Pitié-Salpêtrière (APHP) Université Pierre et Marie Curie (UPMC)


title: Effect on Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients

acronym: SEPIA

summary: Main purpose of the study is to evaluate the effect of sevoflurane on intra cranial pressure (ICP) after traumatic brain injury. Patients admitted for traumatic brain injury equipped with ICP measurement will be sedated with sevoflurane via the Anaconda device during 12 hours. Sedation will be controlled with BIS.

location_facility: Reanimation Chirurgicale - Hôpital Kremlin Bicêtre


title: Randomized to Assess the Efficacy of Whole Brain Radiation Therapy (WBRT) With Concomitant Gefitinib Followed by Maintenance Gefitinib, and Gefitinib Alone, in Lung Cancer Patients With Brain Metastasis

acronym: ARPEGE

summary: Multicentre randomised (1:1) trial assessing the efficacy of whole brain radiotherapy in addition to Gefitinib for the management of brain metastasis in lung cancer patients with a mutated EGFR.

location_facility: Service de Neurologie - Hôpital Avicenne


title: Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement for the Treatment of Lesions of the Ventricular Outflow Tract.

acronym: REVALV

summary: This prospective interventional study is designed to evaluate the cost/advantage ratio in the treatment of lesions of the right ventricular outflow tract using transcatheter pulmonary valved stent (Melody).

ReferenceCitation: Fraisse A, Aldebert P, Malekzadeh-Milani S, Thambo JB, Piéchaud JF, Aucoururier P, Chatelier G, Bonnet D, Iserin L, Bonello B, Assaidi A, Kammache I, Boudjemline Y. Melody ® transcatheter pulmonary valve implantation: results from a French registry. Arch Cardiovasc Dis. 2014 Nov;107(11):607-14. doi: 10.1016/j.acvd.2014.10.001. Epub 2014 Nov 6.

family: Fraisse

full_name: Alain Fraisse

given: Alain

family: Aldebert

full_name: Philippe Aldebert

given: Philippe

family: Malekzadeh-Milani

full_name: Sophie Malekzadeh-Milani

given: Sophie

family: Thambo

full_name: Jean-Benoit Thambo

given: Jean-Benoit

family: Piéchaud

full_name: Jean-François Piéchaud

given: Jean-François

family: Aucoururier

full_name: Pascaline Aucoururier

given: Pascaline

family: Chatelier

full_name: Gilles Chatelier

given: Gilles

family: Bonnet

full_name: Damien Bonnet

given: Damien

family: Iserin

full_name: Laurence Iserin

given: Laurence

family: Bonello

full_name: Béatrice Bonello

given: Béatrice

family: Assaidi

full_name: Anass Assaidi

given: Anass

family: Kammache

full_name: Issam Kammache

given: Issam

family: Boudjemline

full_name: Younes Boudjemline

given: Younes

journal_name: Archives of Cardiovascular Diseases

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Melody® transcatheter pulmonary valve implantation: Results from a French registry

intervention_type: Device


title: Radiological, Biological, Genetic and Micro-architectural Bone Determinants of Fractures in Men With Low Bone Mineral Density

acronym: OSTEHOM

summary:
Rational: Osteoporosis in men is responsible for one third of fragility fractures. However the definition and especially the determinants of fracture in humans are less well known than in women.

Primary Objective: To search radiologic, biochemical, genetic and micro-architecture bone factors associated to fractures in men with low bone density.

Study design: case/control study (fracture vs. no fracture) with men selected according to low bone density (Z-score<-2).

Eligibility criteria: Included subjects will be men whose age is ³ 40 and £ 70 years with a Z-score< -2 at least at one of the 3 measured sites (wrist, lumbar spine, femoral neck). Subjects with secondary osteoporosis will be excluded (corticosteroid treatment, hypogonadism, …) Progress of the study: The recruitment will be over two years. The study will include two periods, an inclusion visit and a period of 3 months to achieve radiological and biological examinations. The subjects will be recruited in the 3 rheumatology departments (LARIBOISIERE, COCHIN). Subjects will be investigated at LARIBOISIERE hospital to perform radiological examinations and biological sampling for laboratory tests within 3 months of enrollment.

Evaluation criteria: Biochemistry: dosages of sexual steroids, bone remodeling markers and homocysteine; Genetic: evaluation of polymorphism of candidates genes associated to fragility fractures (collagen type I, homocysteine, LRP5); Radiology: evaluation of bone micro-architecture with a scan of lumbar spine and hip and peripheral micro-scan (XTREME sSCANCO) and bone densitometry at spine, femoral neck and wrist.

Duration of participation: there is no follow up Total duration of the study: 2 years and 3 months. Number of subjects: 100 patients with fracture and 100 controls without fracture

location_facility: Fédération de Rhumatologie - Hôpital LARIBOISIERE


title: Place Des D-dimères Dans la Prise en Charge Des Patients en Fibrillation Auriculaire : Evaluation de la Valeur prédictive Des D-dimères Sur la Survenue d'événements Thromboemboliques

acronym: COAGFAII

summary: The primary aim of the study was to assess whether D-Dimer level at entry or an increase of D-Dimer level during the follow-up could predict the occurrence of subsequent cardiovascular events in patients with atrial fibrillation.

ReferenceType: background

ReferenceCitation: Mahé I, Drouet L, Simoneau G, Minh-Muzeaux S, Caulin C, Bergmann JF. D-dimer can predict survival in patients with chronic atrial fibrillation. Blood Coagul Fibrinolysis. 2004 Jul;15(5):413-7.

ReferenceCitation: Mahé I, Drouet L, Chassany O, Mazoyer E, Simoneau G, Knellwolf AL, Caulin C, Bergmann JF. D-dimer: a characteristic of the coagulation state of each patient with chronic atrial fibrillation. Thromb Res. 2002 Jul 15;107(1-2):1-6.

ReferenceCitation: Mahé I, Grenard AS, Joyeux N, Caulin C, Bergmann JF. Management of oral anticoagulant in clinical practice: a retrospective study of 187 patients. J Gerontol A Biol Sci Med Sci. 2004 Dec;59(12):1339-42.

ReferenceCitation: Lafuente-Lafuente C, Mahé I, Extramiana F. Management of atrial fibrillation. BMJ. 2009 Dec 23;339:b5216. doi: 10.1136/bmj.b5216. Review.

lead_sponsor: Hopital Lariboisière


intervention_type: Radiation

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

source: euctr

title: Randomized Phase 2 Trial Evaluating the Acute Toxicity of Two Protocols of Reirradiation After Surgery in an Irradiated Area for Carcinoma of the Upper Aerodigestive Tract - Single-fraction Radiotherapy With Concomitant 5FU and Hydrea Administered Every Other Week - Continuous Hyperfractionated Radiotherapy With Concomitant Cetuximab

summary: Patients will be randomised after surgery, provided surgery is macroscopically adequate, that there is a flap of tissue protecting the vascular axis and that wound healing allows reirradiation to begin less than 8 weeks after surgery.Reirradiation will begin in the two arms less than 8 weeks after surgery in the irradiated area. The reirradiated volume : tumour bed + a safety margin of < 2 cm with immediate protection of bone marrow. This volume should be jointly defined by the radiotherapist and the surgeon. During reirradiation, 60 Gy will be delivered in the two arms but will last 11 weeks in the reference arm and 5 weeks in the investigational arm.Acute toxicity (NCI-CTCAE) will be evaluated at the end of reirradiation and at 6 months from randomization (first follow-up consultation)


title: COL4A1 Gene Related Cerebra-retinal Angiopathy : Clinical Spectrum From Children to Adult, Mutational Spectrum and Application to Routine Management of Affected Patients : a Prospective Cohort Study

summary: This prospective multicenter cohort study aims to define the clinical, radiological and mutational spectrum of the disease related to COL4A1 gene.

time_perspective: Cross-Sectional

location_facility: Hôpital LARIBOISIERE Neurology Department

intervention_type: Genetic


title: Prevalence of Mucosal Biofilm Formations in Adenoidectomy Specimens. A Case Control Study

acronym: BOLERO

summary: Rationale: Bacterial biofilms are defined as an assemblage of bacterial cells enclosed in a self-produced glycocalyx matrix. Adherence on surfaces, and resistance to both antibiotic treatments and host defenses are ones of the major clinical features of bacterial biofilms. Hence, biofilm formations represent a serious clinical problem: they persist in human tissues and play a role in a large number of chronic and resistant infections. It has been estimated that more than 65% of all human bacterial infections involve biofilms. Recently, the investigators have demonstrated the presence of mucosal bacterial biofilms in adenoid tissues removed during routine adenoidectomy. Bacterial biofilms were visualized using Confocal Laser Scanning Microscopy (CLSM) with a technique of double staining showing both the bacterial cells and the glycocalyx matrix. Although this study clearly established that adenoids tissues can harbour mucosal biofilms, the prevalence of 54% the investigators found suggested that some groups of children may contain more biofilm formations than others. In an effort to relate the findings of mucosal biofilm with the clinical presentation, the investigators have designed the present work to compare the prevalence of mucosal biofilms in adenoidectomy specimens in two groups: one group of children with chronic otitis media (COM) with effusion versus another group of children without any COM, having adenoids removed for chronic obstruction.

primary_purpose: Health Services Research


title: Short Term Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence:Randomized Controlled Study

acronym: TENSIA

summary:
Fecal incontinence is a major public health issue since 10% of the French population aged 45 has to deal with it. Different treatments exist and have already been evaluated, like the sacral nerve stimulation (SNS) which has proved to be efficient in 75 to 100% of the anal incontinence patients without significant sphincteric lesions or rectal prolapse. However, the treatment is expensive and can have side effects. Moreover, about 20 to 30% of the patients can develop a resistance to the SNS only a few months following the definite implantation. Yet the development of the posterior tibial nerve stimulation (PNTS) offers a new perspective. It consists in stimulating the same metameric area as the sacral nerves. It is regularly used for the treatment of urinary incontinence caused by overactive bladder. It is a non-invasive technique, causing but a few side effects. A preliminary study showed that 7 in 10 incontinent patients saw an improvement when treated with PTNS.

Purpose:

The aim of this study is to analyse and evaluate the PTNS technique in the short term as a treatment of anal incontinence. It is done through the means of a multi-centric prospective randomized study.

Patients:

Will be included: all patients followed for anal incontinence (either with liquid or solid stools) having at least one accident a month for 3months, and who are not diagnosed with colorectal lesions and who are without anal or rectal significant anatomic anomalies, without rectal prolapse, and who have failed to respond to medical treatment (such as medicine or perineal reeducation). The main criterium to analyze the efficiency will be the number of fecal incontinence episodes on a bowel diary. The investigators aim to incorporate 144 patients, that is 72 in each group. 12 centers will take part in this study, that will last 2 years and 3 months. They are the centers of: Bordeaux, Clermont-Ferrand, Grenoble, Lyon, Marseille, Nancy, Nantes, Paris, Diaconesses-Croix,Paris Rothschild, Rennes, Rouen, and Toulouse.

Method:

The PTNS consists in setting two electrodes on the posterial tibial nerve pathway. The electrodes are connected to an external stimulator. After having drawn lots, patients will be treated for 3months either with effective stimulation (frequency: 14hz; impulse duration: 210usec;intensity:sensibility threshold), or with shame stimulation (intensity: 0mAmp). There will be two daily sessions of stimulation (effective, or shame), 20 min each. A pre-treatment assessment will be established, composed of a stool diary, a Cleveland Clinic score, a Fecal Incontinence Quality of Life scale and an anorectal manomety, that will all be repeated by the end of the treatment.

Expected Results:

The investigators hope to prove the short term efficacy of the PTNS on anal incontinence patients.

enrollment_type: Anticipated

lead_sponsor: University Hospital, Rouen


title: Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort : the AuBE Study

acronym: AUBE

summary:
The heart rate variability assessment of the sympathetic-parasympathetic balance is a strong analytical tool in the autonomic nervous system (ANS) physiology, at each end of life.

In neonatology, it represents an important marker for understanding the breath and cardiac dysfunction, incriminated in the pathophysiology of unexplained death syndrome and apnea-bradycardia of prematurity.

If recent clinical studies conducted by our team highlight a close link between the maturation degree of the ANS and gestational or postnatal age, with a substantial autonomic dysfunction in preterm infants, no study to date has focused profile autonomic maturation in the first two years of life, as that period for the infant is a vulnerability "window" especially cardiopulmonary and neurological.

Psychomotor prognosis of newborns is more serious if prematurity is important and if periventricular leukomalacia or cortical anatomical brain lesions are obvious. However, the conventional imaging (Trans fontanel ultrasound, CT, MRI) is not sufficient in the neonatal period to thoroughly evaluate the neurological risk situations. During the neonatal period, the assessment of autonomic control, in practice easily quantifiable from time and frequency-domain analysis of cardiac RR variability, could be a strong marker, at a given time, from a neurological disorder undetectable by imaging, including sympathetic and parasympathetic nerve conduction dysfunction in some brainstem nuclei and cortical areas.

The postnatal profile of the autonomic balance, as a marker of well ANS regulation could become an additional support to correlate transient or permanent autonomic deficit with a psychomotor development disorder at 2 years of age or later. This tool could be a help to target the children with a neurological risk and to schedule early therapeutic interventions and psychological or educational support.

ReferenceCitation: Patural H, Teyssier G, Pichot V, Barthelemy JC. [Normal and changed heart rate maturation of the neonate]. Arch Pediatr. 2008 Jun;15(5):614-6. doi: 10.1016/S0929-693X(08)71851-7. French.

ReferenceCitation: Patural H, Pichot V, Jaziri F, Teyssier G, Gaspoz JM, Roche F, Barthelemy JC. Autonomic cardiac control of very preterm newborns: a prolonged dysfunction. Early Hum Dev. 2008 Oct;84(10):681-7. doi: 10.1016/j.earlhumdev.2008.04.010. Epub 2008 Jun 16.

family: Patural

full_name: Hugues Patural

given: Hugues

family: Pichot

full_name: Vincent Pichot

given: Vincent

family: Jaziri

full_name: Fethi Jaziri

given: Fethi

family: Teyssier

full_name: Georges Teyssier

given: Georges

family: Gaspoz

full_name: Jean-Michel Gaspoz

given: Jean-Michel

family: Roche

full_name: Frédéric Roche

given: Frédéric

family: Barthelemy

full_name: Jean-Claude Barthelemy

given: Jean-Claude

journal_name: Early Human Development

title: Autonomic cardiac control of very preterm newborns: A prolonged dysfunction

ReferenceCitation: De Rogalski Landrot I, Roche F, Pichot V, Teyssier G, Gaspoz JM, Barthelemy JC, Patural H. Autonomic nervous system activity in premature and full-term infants from theoretical term to 7 years. Auton Neurosci. 2007 Oct 30;136(1-2):105-9. Epub 2007 Jun 7.


title: Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET

acronym: CHIMTEP

summary:
18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches.

We propose to conduct a prospective study to evaluate early therapeutic response using 18F-FDG PET before and after the 1st cycle of neo-adjuvant chemotherapy for breast cancer patients.

Variation of 18F-FDG PET uptake is compared to clinical and echographical tumor response evaluated after 3 cycles of chemotherapy.

The purpose is to estimate the capacity of 18F-FDG PET to differentiate responder and non-responder patients.

lead_sponsor: Centre Oscar Lambret

lead_sponsor_type: industriel


title: Economic and Medical Evaluation of the Whole Mitochondrial DNA Screening by Surveyor and Mitochips Techniques.

summary:
Mitochondrial diseases are the most frequent metabolic diseases (2.5 persons among 10 000) and are clinically heterogeneous making diagnosis particularly challenging for clinicians.

Molecular analysis of mitochondrial DNA (mtDNA) is a critical step in diagnosis and genetic counselling of respiratory chain defects. DNA sequencing remains the gold standard but it is time-consuming and fails to detect mutations that may be present at a low heteroplasmic level (20% or below); therefore the diagnosis is yet based on the detection of a few number of pathogenic mutations.

The present study aims to evaluate the benefit and the cost of a diagnosis strategy based on the combined use of 2 techniques named "Surveyor Nuclease" and "Mitochip". Surveyor nuclease is a mismatch-specific DNA endonuclease that will be used for screening the entire mtDNA in order to identify heteroplasmic mutations. In absence of any identified mutation, another technique based on the use an oligonucleotide sequencing microarray (MitoChip) will be performed for the identification of homoplasmic mutations. Mitochip is an array-based sequencing platform for rapid and high-throughput analysis of mitochondrial DNA.

The economical study will compare the cost of these techniques to the standard diagnosis method in term of direct and indirect costs

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: CHU de Nice - Medical genetics laboratory


title: Prospective Randomized Study Comparing Balloon Kyphoplasty and Conservative Treatment in Acute Traumatic Vertebral Fractures, Types A1, A2, AND A3.1 According to the Magerl Classification (STIC 3)

summary:
This study will compare two treatments in acute stable traumatic vertebral fractures (types A1, A2 and A3.1 in MAGERL Classification). The two treatments are the followings:

Conservative Orthopedic Management consisting of brace and pain medication.
Percutaneous Balloon Kyphoplasty, a variant of Vertebroplasty, in which a balloon is first placed into the fractured vertebra and inflated with fluid in order to create a cavity. This may restore part of the vertebral height loss due to the fracture and facilitate the injection of the cement with low pressure.

The primary outcome will be the variation in the angle of Regional Vertebral Kyphosis (or, in the case of asymmetrical fractures, the angle of lateral vertebral inclination) between inclusion and one year follow-up. It will indicate if Balloon Kyphoplasty is able to restore vertebral height of the fractured vertebra better than Conservative Orthopedic Management.

location_facility: Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire


title: Prospective Cohort Study on the Feasibility and Reliability of 'Open' Balloon Kyphoplasty in Types A3.2, A3.3, B1 and C1 MAGERL Classification Vertebral Fractures(STIC 4)

summary:
Some unstable traumatic vertebral fractures (types A3.2, A3.3, B1 et C1 according to MAGERL classification) may undergo unpredictable secondary displacement. Such fractures require a two session surgery with a first operation carried out immediately to achieve posterior fixation and a second surgery which is performed some days later to stabilize the anterior spine and restore stress resistance.

Goal of the present study is to show that percutaneous Balloon Kyphoplasty is able to restore anterior spine strength and replace second session surgery.

primary_purpose: Prevention

location_facility: Service de Radiologie, Hôpital Lariboisière


title: Prospective Randomized Study of Balloon Kyphoplasty and Vertebroplasty in Subacute (Older Than 6 Weeks) Osteoporotic Vertebral Fractures (STIC2)

summary:
This study aims to compare two treatments in subacute (more than 6 week duration) non-traumatic (usually osteoporotic) vertebral fractures. The two treatments are the following:

Vertebroplasty consisting in the percutaneous injection into the fractured vertebra of polymethylmetacrylate cement (the cement used to fix prosthesis in joint replacement) through a posterior route through the vertebral pedicles under radiological guidance.
Balloon Kyphoplasty which consists of placing through a percutaneous posterior approach under radiological guidance, into the fractured vertebra a balloon which is inflated with fluid and creates a cavity. This may restore part of the vertebral height loss due to the fracture. In addition, after balloon deflation, polymethylmetacrylate cement is injected with low pressure into the created cavity to fix fracture reduction. The study will indicate if balloon kyphoplasty is able to restore vertebral height of the fractured vertebra better than vertebroplasty.


title: Prospective Randomized Comparative Study of Balloon Kyphoplasty,Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures of Less Than 6 Weeks

summary: This study aims to compare three treatments in recent (less than 6 week duration) non-traumatic ( usually osteoporotic) vertebral fractures.


title: Exploration of the Lipid Metabolism During the Diabetic Pregnancies and Research for New Biological Predictors to Nutritional Interventions

acronym: DIAMANT

summary:
Justification:

Intrauterine exposure to type 1 or type 2 diabetes increase the risk of macrosomia (35 % to 50 % versus 10 % in general population) despite a good glycemic control. The consequences are : shoulder's dystocia, lung immaturity, caesarean section, neonatal hypoglycaemia and a high frequency of obesity and metabolic disorders in adults.

The mechanisms of macrosomia are unclear; chronic hyperglycemia and subsequent hyperinsulinaemia observed during the diabetic pregnancy might explain only partially the fetal weight. Considerable interest has been generated over the last decade on the lipids and fatty acids alterations in diabetes pregnancies. Change in lipoproteins metabolism have been described associated with macrosomia. Maternal nutrition before and during pregnancy plays an important role in fetal growth and subsequent development of an increased susceptibility to obesity and diabetes in later life.

Main objective:

Looking for an association between maternal and fetal blood lipid parameters and birth weight and body fat in a context of type 1 or type 2 diabetes.

Secondary objectives:

Identify lipid markers associated with fetal macrosomia.
Analyze the placenta by measuring the expression of genes implicated in the storage and the transfer of fatty acids.
Analyze and compare the expression level of placental genes subjected to parental imprinting and validated in animal models.

lead_sponsor: University Hospital, Lille


title: Cardiac Autonomic Functions During Head-out Immersion and During Head Down Tilt

acronym: IMMERSION

summary:
Head down tilt (HDT) was widely used to simulate microgravity effects on cardiovascular system. HDT could be a suitable model of water immersion (WI) which is also used to simulate the cardiovascular effects of microgravity and which is not easy to study in laboratory. To define the possibility to simulate immersion by HDT, a comparison between these models is required. A comparison between WI and few angles during HDT seems necessary to understand which angle is more adapt.

The immersion induces an increase of the central blood volume. This increase is caused by a redistribution of blood from peripheral portions of the body to the intrathoracic circulation. It seems to load cardiopulmonary and arterial baroreceptors. These baroreceptors bring into play autonomic nervous system (ANS) activation and induce a bradycardia.

HDT induces an increase in central blood volume as supported by the central venous pressure and cardiac volume increase and in return, MSNA and heart rate decrease. These cardiovascular effects seem to be the same as the thermoneutral immersion and suggest that the ANS activation is the same during HDT and WI.

Nevertheless, a few previous studies about ANS in HDT indicate some discordant results: a sympathetic decrease was reported but several results show an increase of parasympathetic activity linked with a trend of increase of arterial baroreflex. The aim of this study is to assess ANS activity in HDT on different angles (-6° and -15°) and WI. The investigators suppose an increase of parasympathetic activity during WI corresponding to parasympathetic activation during HDT especially at -6°.

primary_purpose: Basic Science

ReferenceCitation: Gabrielsen A, Johansen LB, Norsk P. Central cardiovascular pressures during graded water immersion in humans. J Appl Physiol (1985). 1993 Aug;75(2):581-5.

ReferenceCitation: Shiraishi M, Schou M, Gybel M, Christensen NJ, Norsk P. Comparison of acute cardiovascular responses to water immersion and head-down tilt in humans. J Appl Physiol (1985). 2002 Jan;92(1):264-8.

ReferenceCitation: Ueno LM, Miyachi M, Matsui T, Takahashi K, Yamazaki K, Hayashi K, Onodera S, Moritani T. Effect of aging on carotid artery stiffness and baroreflex sensitivity during head-out water immersion in man. Braz J Med Biol Res. 2005 Apr;38(4):629-37. Epub 2005 Apr 13.


title: Phase 4 Randomized Multicentric Controlled Study on Impact of Continuous Venovenous Hemofiltration on Organ Failure at the Early Phase of Severe Sepsis

summary: The impact of continuous veno-venous haemofiltration (CVVH) on sepsis-induced multiple organ failure severity is controversial. We thus sought to assess the effect of early application of haemofiltration on the degree of organ dysfunction and plasma cytokine levels in patients with severe sepsis or septic shock.

primary_purpose: Supportive Care


title: Phase III : Preventing Lack of Iodine During Pregnancy. Effect of Supplying Woman With Potassium Iodine to the Neuro-Cognitive Children Development Until Two Years

summary: The purpose of this study is to evaluate the efficacy of potassium iodide during pregnancy on neuro-cognitive development of children followed up until two years.

ReferenceCitation: Caron P, Hoff M, Bazzi S, Dufor A, Faure G, Ghandour I, Lauzu P, Lucas Y, Maraval D, Mignot F, Réssigeac P, Vertongen F, Grangé V. Urinary iodine excretion during normal pregnancy in healthy women living in the southwest of France: correlation with maternal thyroid parameters. Thyroid. 1997 Oct;7(5):749-54.

ReferenceCitation: Caron Ph, D Glinoer La fonction thyroïdienne au cours de la grossesse La Thyroïde. De la physiologie cellulaire aux dysfonctionnements. Des concepts à la pratique. Ed Expansion Scientifique - Paris, 2001, 495-500.


title: Sevoflurane-induced Prevention of Ischemia-reperfusion Lesions in Renal Allograft Transplants Recipients

acronym: SévoRein

summary:
Renal transplantation is characterized by ischemia-reperfusion lesions in allograft. In a previous study, Julier and al. (Anesthesiology 2003) have demonstrated that sevoflurane reduces glomerular lesions in kidney of patients undergoing a cardiovascular surgery and présenting with ischemia-reperfusion phenomena.

The purpose of the study is to evaluate the effects of sevoflurane on the recovery of renal graft function in patients after kidney transplantation.

This study will be a randomized, double blinded, controlled clinical trial and 120 patients undergoing renal allograft transplantation will be included.

Patients will be divided into 2 groups: one group of patients who will receive sevoflurane (evaluated treatment) for anaesthesia and the other one who will receive propofol (reference treatment).

We will evaluate renal function for one year after transplantation. Ours results will confirm or not that sevoflurane protects kidney function from ischemia-reperfusion lesions.

lead_sponsor: University Hospital, Bordeaux

location_facility: Département d'anesthésie réanimation 1 - Hôpital Pellegrin - CHU de Bordeaux


title: Anaesthesia With Propofol Versus Midazolam : Effect on Oxidative Stress in the Brain of Head Trauma Patients

acronym: PROMIS

summary: Severe traumatic brain injury is associated with an increased production of free radicals causing brain damage. First line treatment of these patients aims to maintain cerebral perfusion and includes deep anaesthesia. Propofol has recently shown anti oxidant properties that need to be confirmed when used in these patients. The main objective of this study is to evaluate the effect of propofol compared to midazolam on intra cerebral oxidative stress following severe traumatic brain injury.

lead_sponsor: Rennes University Hospital

location_facility: Réanimation Chirurgicale - Hôpital de Pontchaillou


title: Evaluation of the Impact of a Comprehensive Clinical Management on the Quality of Blood Pressure and Glycemic Control in Diabetic Uremic Patients

summary: Diabetes is the leading cause of end-stage renal disease in developed countries. Hypertension and metabolic control are known to affect the progression of renal deficiency and patient's outcome. Our project aims at implementing a multidisciplinary and systematic approach of diabetic patients with renal deficiency, and at evaluating the impact of metabolic and blood pressure targets as recommended by current guidelines.

status: Unknown status

study_completion_date_type: Anticipated

location_facility: Service de Néphrologie-Hémodialyse du Pr C.Combe, Hôpital Pellegrin, Place Amélie Raba-Léon


title: Pharmacogenomic Study Realized Within the Framework of the Common Care to "Non-small Cell Lung Carcinoma" at Any Stages Treated by Chemotherapy.

acronym: Pharmacogenos

summary: The purpose of this study is to correlate molecular genetic profile with response to chemotherapy in case of primary chemotherapy treatment for non-small cells lung carcinoma.

ReferenceCitation: Beer DG, Kardia SL, Huang CC, Giordano TJ, Levin AM, Misek DE, Lin L, Chen G, Gharib TG, Thomas DG, Lizyness ML, Kuick R, Hayasaka S, Taylor JM, Iannettoni MD, Orringer MB, Hanash S. Gene-expression profiles predict survival of patients with lung adenocarcinoma. Nat Med. 2002 Aug;8(8):816-24. Epub 2002 Jul 15.

ReferenceCitation: Dumontet C, Sikic BI. Mechanisms of action of and resistance to antitubulin agents: microtubule dynamics, drug transport, and cell death. J Clin Oncol. 1999 Mar;17(3):1061-70. Review.

ReferenceCitation: Dumontet C, Morschhauser F, Solal-Celigny P, Bouafia F, Bourgeois E, Thieblemont C, Leleu X, Hequet O, Salles G, Coiffier B. Gemcitabine as a single agent in the treatment of relapsed or refractory low-grade non-Hodgkin's lymphoma. Br J Haematol. 2001 Jun;113(3):772-8.

ReferenceCitation: Galmarini CM, Mackey JR, Dumontet C. Nucleoside analogues and nucleobases in cancer treatment. Lancet Oncol. 2002 Jul;3(7):415-24. Review.

ReferenceCitation: Howard BA, Wang MZ, Campa MJ, Corro C, Fitzgerald MC, Patz EF Jr. Identification and validation of a potential lung cancer serum biomarker detected by matrix-assisted laser desorption/ionization-time of flight spectra analysis. Proteomics. 2003 Sep;3(9):1720-4.

ReferenceCitation: Tissot C, Toffart AC, Villar S, Souquet PJ, Merle P, Moro-Sibilot D, Pérol M, Zavadil J, Brambilla C, Olivier M, Couraud S. Circulating free DNA concentration is an independent prognostic biomarker in lung cancer. Eur Respir J. 2015 Dec;46(6):1773-80. doi: 10.1183/13993003.00676-2015. Epub 2015 Oct 22.

family: Tissot

full_name: Claire Tissot

given: Claire

family: Toffart

full_name: Anne-Claire Toffart

given: Anne-Claire

family: Villar

full_name: Stéphanie Villar

given: Stéphanie

family: Souquet

full_name: Pierre-Jean Souquet

given: Pierre-Jean

family: Merle

full_name: Patrick Merle

given: Patrick

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Pérol

full_name: Maurice Pérol

given: Maurice

family: Zavadil

full_name: Jiri Zavadil

given: Jiri

family: Brambilla

full_name: Christian Brambilla

given: Christian

family: Olivier

full_name: Magali Olivier

given: Magali

family: Couraud

full_name: Sébastien Couraud

given: Sébastien

journal_name: European Respiratory Journal

evidence: open (via free pdf)

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

ReferenceCitation: Toffart AC, Moro-Sibilot D, Couraud S, Merle P, Perol M, Girard N, Souquet PJ, Mastroianni B, Ferretti GR, Romand P, Chatellain P, Vesin A, Brambilla E, Brambilla C, Timsit JF. Evaluation of RECIST in chemotherapy-treated lung cancer: the Pharmacogenoscan Study. BMC Cancer. 2014 Dec 20;14:989. doi: 10.1186/1471-2407-14-989.

family: Perol

full_name: Maurice Perol

family: Girard

full_name: Nicolas Girard

given: Nicolas

family: Mastroianni

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

ReferenceCitation: Toffart AC, Pizarro CA, Schwebel C, Sakhri L, Minet C, Duruisseaux M, Azoulay E, Moro-Sibilot D, Timsit JF. Selection criteria for intensive care unit referral of lung cancer patients: a pilot study. Eur Respir J. 2015 Feb;45(2):491-500. doi: 10.1183/09031936.00118114. Epub 2014 Oct 16.


title: GRAALL 2003 Trial (ALL 15-59 Years). Feasibility of Risk-Adapted Therapy in Young Adult Acute Lymphoblastic Leukemia: a Multicenter Trial

summary: Several prognostic predictors, including baseline ALL features and response to initial therapy, have been described in adult ALL raising the issue of whether these predictors might be redundant and which must be considered for treatment stratification. In the GRAALL-2003 prospective Phase 2 study, we aim to hierarchize the following high-risk factors in Ph-negative ALL patients.

ReferenceCitation: Touzart A, Boissel N, Belhocine M, Smith C, Graux C, Latiri M, Lhermitte L, Mathieu EL, Huguet F, Lamant L, Ferrier P, Ifrah N, Macintyre E, Dombret H, Asnafi V, Spicuglia S. Low level CpG island promoter methylation predicts a poor outcome in adult T-cell acute lymphoblastic leukemia. Haematologica. 2020 Jun;105(6):1575-1581. doi: 10.3324/haematol.2019.223677. Epub 2019 Sep 19.

family: Touzart

full_name: Aurore Touzart

given: Aurore

family: Boissel

full_name: Nicolas Boissel

family: Belhocine

full_name: Mohamed Belhocine

given: Mohamed

family: Smith

full_name: Charlotte Smith

given: Charlotte

family: Graux

full_name: Carlos Graux

given: Carlos

family: Latiri

full_name: Mehdi Latiri

given: Mehdi

family: Lhermitte

full_name: Ludovic Lhermitte

given: Ludovic

family: Mathieu

full_name: Eve-Lyne Mathieu

given: Eve-Lyne

family: Huguet

full_name: Françoise Huguet

given: Françoise

family: Lamant

full_name: Laurence Lamant

given: Laurence

family: Ferrier

full_name: Pierre Ferrier

given: Pierre

family: Ifrah

full_name: Norbert Ifrah

given: Norbert

family: Macintyre

full_name: Elizabeth Macintyre

given: Elizabeth

family: Dombret

full_name: Hervé Dombret

given: Hervé

family: Asnafi

full_name: Vahid Asnafi

given: Vahid

family: Spicuglia

full_name: Salvatore Spicuglia

given: Salvatore

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

publisher: Ferrata Storti Foundation (Haematologica)

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

publisher_group: Ferrata Storti Foundation (Haematologica)

publisher_normalized: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Bond J, Touzart A, Leprêtre S, Graux C, Bargetzi M, Lhermitte L, Hypolite G, Leguay T, Hicheri Y, Guillerm G, Bilger K, Lhéritier V, Hunault M, Huguet F, Chalandon Y, Ifrah N, Macintyre E, Dombret H, Asnafi V, Boissel N. DNMT3A mutation is associated with increased age and adverse outcome in adult T-cell acute lymphoblastic leukemia. Haematologica. 2019 Aug;104(8):1617-1625. doi: 10.3324/haematol.2018.197848. Epub 2019 Jan 17.

repository_institution: University of Geneva - Archive ouverte UNIGE

ReferenceCitation: Bond J, Marchand T, Touzart A, Cieslak A, Trinquand A, Sutton L, Radford-Weiss I, Lhermitte L, Spicuglia S, Dombret H, Macintyre E, Ifrah N, Hamel JF, Asnafi V. An early thymic precursor phenotype predicts outcome exclusively in HOXA-overexpressing adult T-cell acute lymphoblastic leukemia: a Group for Research in Adult Acute Lymphoblastic Leukemia study. Haematologica. 2016 Jun;101(6):732-40. doi: 10.3324/haematol.2015.141218. Epub 2016 Mar 4.

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

ReferenceCitation: Chien WW, Catallo R, Chebel A, Baranger L, Thomas X, Béné MC, Gerland LM, Schmidt A, Beldjord K, Klein N, Escoffre-Barbe M, Leguay T, Huguet F, Larosa F, Hayette S, Plesa A, Ifrah N, Dombret H, Salles G, Chassevent A, Ffrench M. The p16(INK4A)/pRb pathway and telomerase activity define a subgroup of Ph+ adult Acute Lymphoblastic Leukemia associated with inferior outcome. Leuk Res. 2015 Apr;39(4):453-61. doi: 10.1016/j.leukres.2015.01.008. Epub 2015 Jan 25.

title: The p16INK4A/pRb pathway and telomerase activity define a subgroup of Ph+ adult Acute Lymphoblastic Leukemia associated with inferior outcome

ReferenceCitation: Dhédin N, Huynh A, Maury S, Tabrizi R, Beldjord K, Asnafi V, Thomas X, Chevallier P, Nguyen S, Coiteux V, Bourhis JH, Hichri Y, Escoffre-Barbe M, Reman O, Graux C, Chalandon Y, Blaise D, Schanz U, Lhéritier V, Cahn JY, Dombret H, Ifrah N; GRAALL group. Role of allogeneic stem cell transplantation in adult patients with Ph-negative acute lymphoblastic leukemia. Blood. 2015 Apr 16;125(16):2486-96; quiz 2586. doi: 10.1182/blood-2014-09-599894. Epub 2015 Jan 13.

name: Department of Hematology and University Paris Diderot, Institut Universitaire d’Hématologie, EA-3518, University Hospital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France;

name: Department of Hematology, University Institute of Cancer, Toulouse, France;

name: Department of Hematology, University Hospital Henri Mondor, AP-HP, Créteil, France;

name: Department of Hematology, University Hospital, Bordeaux, France;

name: Department of Hematology, University Paris Descartes Sorbonne Cité, Institut Necker-Enfants Malades, INSERM U1151, and Onco-Hematology Laboratory, Assistance Publique Hôpitaux de Paris, Hôpital Necker-Enfants Malades, Paris, France;

name: Department of Hematology, Hospital Lyon Sud, Pierre Bénite, France;

name: Department of Hematology, University Hospital, Nantes, France;

name: Department of Hematology, University Hospital Pitié-Salpêtrière, Assistance Publique Hôpitaux de Paris, Paris, France;

name: Department of Hematology, University Hospital, Lille, France;

name: Department of Hematology, Institut Gustave Roussy, Villejuif, France;

name: Department of Hematology, University Hospital, Montpellier, France;

name: Department of Hematology, University Hospital, Rennes, France;

name: Department of Hematology, University Hospital, Caen, France;

name: Department of Hematology, University Hospital, Yvoir, Belgium;

name: Division of Hematology, Department of Medical Specialties, University Hospital, Geneva, and Faculty of Medicine, University of Geneva Switzerland and Swiss Group for Clinical Cancer Research, Bern, Switzerland;

name: Department of Hematology, Institut Paoli Calmettes, Marseille, France;

name: Division of Hematology, University Hospital of Zurich, Zurich, Switzerland;

name: Group for Research on Adult Acute Lymphoblastic Leukemia, Coordination Office, Pierre Bénite, France;

name: Department of Hematology, University Hospital, Grenoble, France; and

name: Department of Hematology and INSERM U 892/CNRS 6299, University Hospital, Angers, France

ReferenceCitation: Beldjord K, Chevret S, Asnafi V, Huguet F, Boulland ML, Leguay T, Thomas X, Cayuela JM, Grardel N, Chalandon Y, Boissel N, Schaefer B, Delabesse E, Cavé H, Chevallier P, Buzyn A, Fest T, Reman O, Vernant JP, Lhéritier V, Béné MC, Lafage M, Macintyre E, Ifrah N, Dombret H; Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL). Oncogenetics and minimal residual disease are independent outcome predictors in adult patients with acute lymphoblastic leukemia. Blood. 2014 Jun 12;123(24):3739-49. doi: 10.1182/blood-2014-01-547695. Epub 2014 Apr 16.

name: Department of Biostatistics, University Paris Diderot, Institut Universitaire d’Hématologie, EA-3518 and UMR-S-717, University Hospital Saint-Louis, Assistance Publique – Hôpitaux de Paris, Paris, France;

name: Laboratory of Oncohematology, AP-HP, Hôpital Necker Enfants-Malades, University Paris Descartes Sorbonne Cité, Institut Necker-Enfants Malades, Institut National de Recherche Médicale U1151, Paris, France;

name: Department of Hematology, University Hospital Purpan, Toulouse, France;

name: Department of Hematology, University Hospital Haut-Lévèque, Bordeaux, France;

name: Department of Hematology, University Hospital Lyon Sud, Lyon, France;

name: Department of Hematology, University Hospital Claude Huriez, Lille, France;

name: Department of Hematology, University Hospital, Geneva, Switzerland;

name: Department of Hematology, University Hospital, Zürich, Switzerland;

name: Department of Hematology, University Hospital Robert Debré, Assistance Publique – Hôpitaux de Paris, Paris, France;

name: University Hospital Pitié-Salpêtrière, Assistance Publique – Hôpitaux de Paris, Paris, France;

name: GRAALL Coordination Office, University Hospital Lyon Sud, Lyon, France;

name: Department of Genetics, Aix-Marseille University, Marseille, France; and

name: Department of Hematology, University Hospital, INSERM U892/CNRS 6299, Angers, France

ReferenceCitation: Trinquand A, Tanguy-Schmidt A, Ben Abdelali R, Lambert J, Beldjord K, Lengliné E, De Gunzburg N, Payet-Bornet D, Lhermitte L, Mossafa H, Lhéritier V, Bond J, Huguet F, Buzyn A, Leguay T, Cahn JY, Thomas X, Chalandon Y, Delannoy A, Bonmati C, Maury S, Nadel B, Macintyre E, Ifrah N, Dombret H, Asnafi V. Toward a NOTCH1/FBXW7/RAS/PTEN-based oncogenetic risk classification of adult T-cell acute lymphoblastic leukemia: a Group for Research in Adult Acute Lymphoblastic Leukemia study. J Clin Oncol. 2013 Dec 1;31(34):4333-42. doi: 10.1200/JCO.2012.48.5292. Epub 2013 Oct 28.

name: Amélie Trinquand, Raouf Ben Abdelali, Etienne Lengliné, Noémie De Gunzburg, Ludovic Lhermitte, Jonathan Bond, Agnès Buzyn, Elizabeth Macintyre, and Vahid Asnafi, University Paris Descartes, Centre National de la Recherche Scientifique (CNRS) Unité Mixte de Recherche (UMR)-8147, and Assistance Publique–Hôpitaux de Paris (AP-HP), Hôpital Necker-Enfants Malades; Jérôme Lambert, UMR-S-717, Hôpital Saint-Louis, AP-HP; Kheira Beldjord, Etienne Lengliné, and Hervé Dombret, University Paris 7, Hôpital Saint...

publisher: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Toward a NOTCH1/FBXW7/RAS/PTEN–Based Oncogenetic Risk Classification of Adult T-Cell Acute Lymphoblastic Leukemia: A Group for Research in Adult Acute Lymphoblastic Leukemia Study

ReferenceCitation: Maury S, Huguet F, Leguay T, Lacombe F, Maynadié M, Girard S, de Labarthe A, Kuhlein E, Raffoux E, Thomas X, Chevallier P, Buzyn A, Delannoy A, Chalandon Y, Vernant JP, Rousselot P, Macintyre E, Ifrah N, Dombret H, Béné MC; Group for Research on Adult Acute Lymphoblastic Leukemia. Adverse prognostic significance of CD20 expression in adults with Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia. Haematologica. 2010 Feb;95(2):324-8. doi: 10.3324/haematol.2009.010306. Epub 2009 Sep 22.

name: for the Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL)

location_facility: Service d'Hématologie Clinique, Hôpital Purpan


title: Importance of Left Ventricular Pacing Site in Biventricular Resynchronization Therapy for Severe Heart Failure

summary: Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site. We study in a random order 11 different left ventricular pacing sites and compare their hemodynamics using pressure-volume catheters. The consequences on the surface ECG are also assessed.

location_facility: Hôpital Cardiologique du Haut Lévêque, Rythmology department, Pr CLEMENTY, 3rd Floor


title: Treatment of Renal Tumors With Radiofrequency: Efficacy Evaluation in Comparison With Conservative Surgery (Multicentric Randomized Trial)

summary: Surgical treatment of multiple or recurrent renal tumors may be complicated by renal function impairment. Mini-invasive thermotherapy as radiofrequency (RF), induces necrosis of tumoral tissue while sparing normal renal parenchyma. The purpose of the study is to compare, in patients at risk of renal insufficiency, a strategy based on surgical approach and a strategy based on RF approach. 180 patients from 9 centers will be randomized in two groups (surgical vs. RF, delivered either percutaneously or under laparoscopy). The proportion of patients with a local carcinologic efficacy at 5 years and the general and renal tolerance will be analysed and compared between both strategies.

location_facility: Service de radiologie B, Hôpital Pellegrin


title: Early Treatment of Paroxysmal Dysautonomia and Hypertonia for Severe Brain Injured Patients by Intrathecal Baclofen Therapy

summary: Within the framework of a prospective double-blind and randomized study evaluating the efficacy of continuous intrathecal baclofen therapy (CIBT) on paroxysmal dysautonomia (main objective) and hypertonia, recovery and tolerance (secondary objectives) during the initial recovery phase of severe head injury, continuous intrathecal baclofen infusion will be delivered. The first week of study is double-blind: the first of two parallel groups receives CIBT and the second group receives placebo. The main outcome (number of neurovegetative episodes) is assessed at the end of first week. The second week of study is open labeled: active treatment is continued in the first group and the second group starts active CIBT treatment. The third week of study, treatment is stopped in both groups.

location_facility: Service de neurochirurgie B, Hôpital Pellergin Tripode


title: Prospective, Randomized, Simple Blind Study Comparing the Effects of an Anaesthesia With Propofol to an Anaesthesia With Desflurane on Oxydative Stress and Liver Function Recovery After Hepatectomy

summary:
Propofol is an anaesthetic agent that showed in vitro and in vivo anti oxidant properties. No data are available concerning the potential benefit of a total anaesthesia with propofol in partial hepatic surgery. Patients who undergo partial hepatic resection have frequent liver insufficiency that could be related in part to the oxidative stress induced by clamping the hepatic vessels during the surgical intervention. Our hypothesis is that propofol, by increasing liver resistance to this ischemia-reperfusion phenomenon, could improve the remaining liver function recovery, and therefore could reduce post surgical morbidity.

The aim of the study is to evaluate the anti oxidant effects of propofol compared to another widely used anaesthetic agent, inhaled desflurane, during and after partial hepatic resection with hepatic vessels clamping. The primary endpoint will be the level of malondialdehyde (a plasmatic marker of oxidative stress), 30 minutes after the end of hepatic clamping.

location_facility: Surgical Intensive Care Unit - Rennes University Hospital


title: Renal Cell Carcinoma Treatment With Activated Tumor- Infiltrated Lymphocytes. A Non-Randomized Phase II Trial.

summary: Renal cell carcinoma represents today 3% of the solid tumors of the adult. Their bad prognosis is due to the frequency of metastasis and the resistance to chemotherapy. Immunotherapy (interferon-α, interleukin-2) has shown some good results but an important toxicity. In our study, we evaluate the response to a new therapeutic strategy which combines an injection of patient's own activated lymphocytes to a classic immunotherapy with interferon-α and interleukin-2.

ReferenceCitation: Belldegrun A, Pierce W, Kaboo R, Tso CL, Shau H, Turcillo P, Moldawer N, Golub S, deKernion J, Figlin R. Interferon-alpha primed tumor-infiltrating lymphocytes combined with interleukin-2 and interferon-alpha as therapy for metastatic renal cell carcinoma. J Urol. 1993 Nov;150(5 Pt 1):1384-90.

ReferenceCitation: Figlin RA, Pierce WC, Kaboo R, Tso CL, Moldawer N, Gitlitz B, deKernion J, Belldegrun A. Treatment of metastatic renal cell carcinoma with nephrectomy, interleukin-2 and cytokine-primed or CD8(+) selected tumor infiltrating lymphocytes from primary tumor. J Urol. 1997 Sep;158(3 Pt 1):740-5.

ReferenceCitation: Hayakawa M, Hatano T, Ogawa Y, Gakiya M, Ogura H, Osawa A. Treatment of advanced renal cell carcinoma using regional arterial administration of lymphokine-activated killer cells in combination with low doses of rIL-2. Urol Int. 1994;53(3):117-24.

ReferenceCitation: Mathiot C, Thiounn N, Tartour E, Flam T, Peyret C, Joyeux I, Zerbib M, Brandely M, Debré B, Fridman WH. Non-cytotoxic CD4 tumour-infiltrating lymphocytes induce responses in patients with metastatic renal cell carcinoma previously treated with interleukin-2. Eur J Cancer. 1995;31A(9):1551-2.

location_facility: Service d'Urologie - Hôpital Pontchaillou


title: Effect of Magnesium Sulfate on the Incidence of Periventricular Leukomalacia in the Very Preterm Neonate

summary:
Magnesium is neuroprotective in neonatal animal models of acquired hypoxic-ischemic and/or inflammatory cerebral lesions. It is associated with a significant reduction of perinatal death and cerebral palsy in some observational studies.

The objective of the study is to assess if prenatal magnesium sulfate given to women at risk of preterm birth before 33 week's gestation is neuroprotective.

ReferenceCitation: Chollat C, Enser M, Houivet E, Provost D, Bénichou J, Marpeau L, Marret S. School-age outcomes following a randomized controlled trial of magnesium sulfate for neuroprotection of preterm infants. J Pediatr. 2014 Aug;165(2):398-400.e3. doi: 10.1016/j.jpeds.2014.04.007. Epub 2014 May 14.

family: Chollat

full_name: Clément Chollat

given: Clément

family: Enser

full_name: Maya Enser

given: Maya

family: Houivet

full_name: Estelle Houivet

given: Estelle

family: Provost

full_name: Delphine Provost

given: Delphine

family: Bénichou

full_name: Jacques Bénichou

given: Jacques

family: Marpeau

full_name: Loïc Marpeau

given: Loïc

family: Marret

full_name: Stéphane Marret

given: Stéphane

journal_name: The Journal of Pediatrics

title: School-Age Outcomes following a Randomized Controlled Trial of Magnesium Sulfate for Neuroprotection of Preterm Infants


title: Determinants of Muscle Strength in Chronic Kidney Disease

summary:
Aim of this study is to determine in chronic kidney disease patients:

the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C reactive protein and decrease in serum albumin) on voluntary muscle strength impairment
the relationship between voluntary muscle strength and muscle mass
the relationship between voluntary muscle strength and lean body mass
the correlation between voluntary muscle strength and physical activity

ReferenceCitation: Souweine JS, Kuster N, Chenine L, Rodriguez A, Patrier L, Morena M, Badia E, Chalabi L, Raynal N, Ohresser I, Leray-Moragues H, Mercier J, Hayot M, Le Quintrec M, Gouzi F, Cristol JP. Physical inactivity and protein energy wasting play independent roles in muscle weakness in maintenance haemodialysis patients. PLoS One. 2018 Aug 1;13(8):e0200061. doi: 10.1371/journal.pone.0200061. eCollection 2018.

family: Souweine

full_name: Jean-Sébastien Souweine

given: Jean-Sébastien

family: Kuster

full_name: Nils Kuster

given: Nils

family: Chenine

full_name: Leila Chenine

given: Leila

family: Rodriguez

full_name: Annie Rodriguez

given: Annie

family: Patrier

full_name: Laure Patrier

given: Laure

family: Morena

full_name: Marion Morena

given: Marion

family: Badia

full_name: Eric Badia

given: Eric

family: Chalabi

full_name: Lotfi Chalabi

given: Lotfi

family: Raynal

full_name: Nathalie Raynal

given: Nathalie

family: Ohresser

full_name: Isabelle Ohresser

given: Isabelle

family: Leray-Moragues

full_name: Helene Leray-Moragues

given: Helene

family: Mercier

full_name: Jacques Mercier

family: Hayot

full_name: Maurice Hayot

given: Maurice

family: Le Quintrec

full_name: Moglie Le Quintrec

given: Moglie

family: Gouzi

full_name: Fares Gouzi

given: Fares

family: Cristol

full_name: Jean-Paul Cristol

given: Jean-Paul

currency_apc_doaj: USD

journal_name: PLOS ONE

license: cc-by

license_normalized: cc-by

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

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

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

location_facility:
GCS Help Lapeyronie, CHU Montpellier
AIDER


title: SAFEty and Efficacy of HOME-based Hospitalization Versus Inpatient Care for Patients With Acute Heart Failure in Chronic Heart Failure.

acronym: SAFE-HOME

summary: Evaluation of the efficacy, safety and and cost of home care versus conventional hospitalization care at 3-months in patients with worsening chronic heart failure.

status: Recruiting

lead_sponsor: French Cardiology Society

location_facility:
Hôpital Henri Mondor
Hôpital Bicêtre

status_simplified: Ongoing


title: Effectiveness and Cost-effectiveness of Tele-expertise for the Screening Examination of Premature Infants for Retinopathy of Prematurity

acronym: Dite-ROP

summary: The purpose of this study is to determine whether telemedicine would be as effective as having a pediatrics ophthalmologist on site for screening examination of retinopathy in premature infants and would be cost-effective.

ReferenceCitation: Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.

ReferenceCitation: Fierson WM; American Academy of Pediatrics Section on Ophthalmology; American Academy of Ophthalmology; American Association for Pediatric Ophthalmology and Strabismus; American Association of Certified Orthoptists. Screening examination of premature infants for retinopathy of prematurity. Pediatrics. 2013 Jan;131(1):189-95. doi: 10.1542/peds.2012-2996. Epub 2012 Dec 31. Review.

ReferenceCitation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.

family: Charrier

full_name: Nathanael Charrier

given: Nathanael

name: the ARS Ile de France telemedicine group

family: Zarca

full_name: Kevin Zarca

given: Kevin

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

family: Calinaud

full_name: Christine Calinaud

given: Christine

journal_name: BMC Health Services Research

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_facility: Service de réanimation néonatale. Maternité de Port-Royal

location_facility: Service de réanimation néonatale. Centre Hospitalier Sud Francilien


title: Social Web Mining for Suicide Prevention of Young People

acronym: Don't Do It

summary:
According to a recent and alarming WHO (World Health Organisation) report (September 4, 2014), one person dies of suicide every 40 seconds in the world. Suicide is the third-leading cause of death for 15- to 24-year-olds, according to the Centers for Disease Control and Prevention , after accidents and homicide.

This major public health issue need prevention strategies especially directed to at-risk populations. Since 2013, more than 2 billion users are enrolled in social networks such as Twitter or Facebook. Young adults (ages 18 to 29) are the most likely to use social media - fully 90% do.

Consequently, in this project, we focus on suicide prevention in social media network..

The aim of this project is the validation of the algorithm. This algorithm build a decision support system that monitor young people at-risk based on large volume of heterogeneous data collected through social media to improve suicide prevention.

time_perspective: Retrospective

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Prospective Multicentric, Open-label, Randomized Study Assessing the Efficacy of the Removable and Adjustable Preformed Twicare® Appliance Versus Removable Herbst Appliance Treatment in Class II Malocclusion

acronym: EffTwicare

summary: The aim of this prospective, multicentric, randomized, open-label study is to assess the efficacy of the removable Twicare® as mandibular propulsive appliance in children aged from 7 to 12 years old in the course of their orthodontic treatment, showing its noninferiority with the removable Herbst. One untreated group will be included to control the internal validity of the study as recommend in noninferiority trials. Patients will have a follow-up every two months during 6 to 12 months as planned in routine care.

lead_sponsor: FCI System

location_facility: Department of Orthodontics, Faculty of Dentistry


title: Benefits of Therapy With Virtual Reality Exposure in the Treatment of Cocaine Use Disorders

acronym: CORVI

summary: Cocaine addiction is a multifactorial disease with important consequences: somatic, psychiatric... The number of applications for treatment for cocaine addiction is gradually increasing from year to year but no conventional treatment is available. New tools such as virtual reality could be used in this treatment. We propose to create a virtual reality program based on the analysis of high-risk relapse situations described by patients. We will then assess the effect of this cybertherapy on patients' relapse time and their desire to use cocaine

study_start_date_type: Anticipated

status: Not yet recruiting

intervention_type: Behavioral


title: Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely With Respiratory and Neurodevelopmental Impact of Early Treatment With Inhaled Nitric Oxide

summary: Utilization of nitric oxide (NO) therapy has been related to a trend towards short term improvement in very premature infants. A two year follow-up of children treated soon after birth with NO in the neonatal period, suggests that a significant improvement in neurodevelopmental outcome might occur. This study aims to evaluate follow-up at 6 years, in respiratory and neurodevelopmental outcome, of children born very prematurely, some of them having been treated with nitric oxide in the neonatal period.

ReferenceCitation: Hascoet JM, Fresson J, Claris O, Hamon I, Lombet J, Liska A, Cantagrel S, Al Hosri J, Thiriez G, Valdes V, Vittu G, Egreteau L, Henrot A, Buchweiller MC, Onody P. The safety and efficacy of nitric oxide therapy in premature infants. J Pediatr. 2005 Mar;146(3):318-23.

ReferenceCitation: Deforge H, André M, Hascoët JM, Toniolo AM, Demange V, Fresson J. [Cognitive development and attention performances at school age of "normal" prematurely born children]. Arch Pediatr. 2006 Sep;13(9):1195-201. Epub 2006 Jul 7. French.

ReferenceCitation: Hamon I, Varechova S, Vieux R, Ioan I, Bonabel C, Schweitzer C, Hascoet JM, Marchal F. Exercise-induced bronchoconstriction in school-age children born extremely preterm. Pediatr Res. 2013 Apr;73(4 Pt 1):464-8. doi: 10.1038/pr.2012.202. Epub 2012 Dec 26.

family: Hamon

full_name: Isabelle Hamon

family: Varechova

full_name: Silvia Varechova

given: Silvia

family: Vieux

full_name: Rachel Vieux

given: Rachel

family: Ioan

full_name: Iulia Ioan

given: Iulia

family: Bonabel

full_name: Claude Bonabel

given: Claude

family: Schweitzer

full_name: Cyril Schweitzer

given: Cyril

family: Hascoet

full_name: Jean Michel Hascoet

given: Jean Michel

family: Marchal

full_name: François Marchal

given: François

journal_name: Pediatric Research

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: Maternite Regionale Universitaire

location_facility:
CHU Brabois
Maternite Regionale Universitaire


title: Evaluation of the Effects of a Water Cure on Gonarthrosis: Randomized Clinical Study Including Water Cure Versus Continuation of the Usual Treatment

summary: The main objective of this study is to evaluate the therapeutic effect of a thermal treatment on gonarthrosis, with an increase of the number of patients presenting a clinically significant improvement.

ReferenceCitation: Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1145-55. Review.

ReferenceCitation: Ravaud P, Giraudeau B, Logeart I, Larguier JS, Rolland D, Treves R, Euller-Ziegler L, Bannwarth B, Dougados M. Management of osteoarthritis (OA) with an unsupervised home based exercise programme and/or patient administered assessment tools. A cluster randomised controlled trial with a 2x2 factorial design. Ann Rheum Dis. 2004 Jun;63(6):703-8.

ReferenceCitation: Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. Epub 2004 Jun 18.

ReferenceCitation: Verhagen AP, de Vet HC, de Bie RA, Kessels AG, Boers M, Knipschild PG. Balneotherapy for rheumatoid arthritis and osteoarthritis. Cochrane Database Syst Rev. 2000;(2):CD000518. Review. Update in: Cochrane Database Syst Rev. 2003;(4):CD000518.

ReferenceCitation: Zelen M. Randomized consent designs for clinical trials: an update. Stat Med. 1990 Jun;9(6):645-56.

ReferenceCitation: Forestier R, Genty C, Waller B, Françon A, Desfour H, Rolland C, Roques CF, Bosson JL. Crenobalneotherapy (spa therapy) in patients with knee and generalized osteoarthritis: a post-hoc subgroup analysis of a large multicentre randomized trial. Ann Phys Rehabil Med. 2014 Jun;57(4):213-27. doi: 10.1016/j.rehab.2014.03.001. Epub 2014 Mar 27.

family: Forestier

full_name: R. Forestier

given: R.

family: Genty

full_name: C. Genty

given: C.

family: Waller

full_name: B. Waller

given: B.

family: Françon

full_name: A. Françon

given: A.

family: Desfour

full_name: H. Desfour

given: H.

family: Rolland

full_name: C. Rolland

family: Roques

full_name: C.-F. Roques

family: Bosson

full_name: J.-L. Bosson

journal_name: Annals of Physical and Rehabilitation Medicine

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: Crenobalneotherapy (spa therapy) in patients with knee and generalized osteoarthritis: A post-hoc subgroup analysis of a large multicentre randomized trial

ReferenceCitation: Forestier R, Desfour H, Tessier JM, Françon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.

family: Tessier

full_name: J.-M. Tessier

family: Francon

full_name: A. Francon

family: Foote

full_name: A. M. Foote

given: A. M.

journal_name: Annals of the Rheumatic Diseases

lead_sponsor: Association Francaise pour la Recherche Thermale

location_facility:
Cabinet médical
Hôpital thermal
Cabinet Médical