title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Efficacy and Safety of STG320 Sublingual Tablets of House Dust Mite (HDM) Allergen Extracts in Adults and Adolescents With HDM-associated Allergic Rhinitis

summary: The objective of this study was to assess the efficacy and safety of 12 months of treatment with 300 IR of STG320 sublingual tablets compared with placebo in adults and adolescents with HDM-associated allergic rhinitis.

location_facility:
University of South of Florida
CHU Arnaud de Villeneuve


title: A Study Evaluating the Safety and Efficacy of the BioFreedom™ Biolimus A9™ Coated Cobalt Chromium Coronary Stent System in Patients at High Risk of Bleeding

summary: A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt Chromium coronary stent system in patients at high risk of bleeding

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Biosensors Europe SA

sponsor_collaborators:
Biosensors Europe SA
European Cardiovascular Research Center

location_country: Switzerland France

location_facility:
at Hôpital Privé Claude Galien ICPS
Triemli Stadtspital

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: Prevention of Post-operative Atrial Fibrillation by BOTulinum Toxin Injections Into Epicardial Fat Pads Around Pulmonary Veins in Patients Undergoing Cardiac Surgery"

acronym: BOTAF

summary:
Over the past few years, research has focused on the prevention of atrial fibrillation (AF) after cardiac surgery, but highly effective interventions are still missing. Postoperative AF remains the most common complication after cardiac surgery, with an incidence of 10 to 50%. This complication is usually a transient condition that resolves spontaneously but it has major adverse consequences for patients and the health care system, including increased rates of death, complications (strokes), and hospitalisations with inflated costs.

Recently, animal studies have demonstrated that neurotoxins such as botulinum toxin (BTX) injected into fat pads could suppress AF inducibility by parasympathetic activation. Botulinum toxin injection in fat pads has been studied in the dog's heart and could be associated with the reduction of atrial fibrillation in postoperative cardiac surgery. One pilot study has demonstrated the feasibility and safety of this technique in the human heart.

The investigators hypothesize that botulinum toxin injection may substantially reduce postoperative AF during the first postoperative month after cardiac surgery without any serious adverse events. By the suppression of ganglionic plexi (GP) activity in the epicardial fat pads, mild term antiarrhythmic effects can be achieved with fewer antiarrhythmic drugs and anticoagulant treatment.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Individuel participant data that underlie results in publication could be shared Individuel participant data detailed in meta analysis protocol could be shared

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Merz Pharmaceuticals
Ministry of Health, France

location_facility:
Hôpital Européen Georges Pompidou
Corentin Celton
Clinique Ambroise Paré
Institut Mutualiste Montsouris
Hôpital Marie Lannelongue
Hôpital Bichat
Hôpital Saint-Joseph
Centre Cardiologique du Nord
CHU Limoges

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: BOTAF

titre: Prevention of post-operative atrial fibrillation by botulinum toxin injections into epicardial fat pads around pulmonary veins in patients undergoing cardiac surgery

discipline_principale: cardiology

nom_porteur: FLORENS

prenom_porteur: Emmanuelle


lead_sponsor: Orfagen

summary:
Absolute ethanol has been used "off-label" as an unmodified formulation (solution) in Congenital Venous Malformations (CVM). Despite its effectiveness, absolute ethanol appears difficult to handle because of its high diffusion capacity outside the CVM and in the blood circulation. A less diffusible ethanol-based product (ethanol gel) has been developed in order to minimize systemic and local diffusion capacities of ethanol. Therefore, the pharmacokinetic parameters and their clinical and paraclinical outcomes between ethanol gel 96% and absolute ethanol need to be carried out.

FDA Office of Orphan Products Development (FDA OOPD) : Funding source.

location_facility: Hôpital Bretonneau Service de neuroradiologie

title: Systemic and Local Diffusion of Ethanol After Administration of Ethanol 96% Formulated in a Gel and Ethanol 98% Solution by the Percutaneous Route, in Patients With Congenital Venous Malformations:Pharmacokinetic, Pharmacodynamic and Clinical Study.

source: euctr

location_country:
United States
France


title: CO-Rebreathing in Comparison to Isotopic Red Cell Volume Determination in the Diagnosis of Primitive and Secondary Polycythemia: a Multicentric Study. Co-Rebreathing for the Measurement of Total Red Cell Mass in Polycythemia.

acronym: Poly-CO

summary: The optimized CO-Rebreathing is an efficient method to evaluate the red cell mass and has been used in the vast majority of studies in sport medicine. However, this method has never been evaluated on a large scale in the diagnosis of primitive or secondary polycythemia. The standard procedure to evaluate the red cell mass is based on isotopic measurement using Cr51-labelled red cells, but its lack of availability in many centers highlights the need for a non-invasive and rapid alternative method. The purpose of this study is to evaluate and validate the CO-Rebreathing method in this set of indications.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Other


title: Evaluation of Spa Therapy in the Treatment of Plaque Psoriasis, a Randomized, Controlled, Open Multicenter Study

summary: Assessment of quality of life after Spa therapy (4 ½ months follow-up) in the treatment of plaque psoriasis: Spa versus usual care in patients with plaque psoriasis.

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Halverstam CP, Lebwohl M. Nonstandard and off-label therapies for psoriasis. Clin Dermatol. 2008 Sep-Oct;26(5):546-53. doi: 10.1016/j.clindermatol.2007.10.023.

ReferenceCitation: Kazandjieva J, Grozdev I, Darlenski R, Tsankov N. Climatotherapy of psoriasis. Clin Dermatol. 2008 Sep-Oct;26(5):477-85. doi: 10.1016/j.clindermatol.2008.05.001.

ReferenceCitation: ALT J, NONCLERCQ E. [Treatment of psoriasis by ultraviolet and photosensitizers]. Bull Soc Fr Dermatol Syphiligr. 1953 Jul-Oct;60(4):343-5. No abstract available. Undetermined Language.

ReferenceCitation: Grupper C, Bourgeois-Spinasse J, Eisenmann D. [Treatment of psoriasis in 1970]. Cah Med. 1970 Sep;11:Suppl:15-20. No abstract available. French.

ReferenceCitation: Oddoze L, Temime P, Marchand JP, Benne M. [Combined oral meladinine and ultraviolet rays in the treatment of psoriasis. (Preliminary note)]. Bull Soc Fr Dermatol Syphiligr. 1967;74(5):609-10. No abstract available. French.

ReferenceCitation: SOLOMON WM, NETHERTON EW, NELSON PA, ZEITER WJ. Treatment of psoriasis with Goeckerman technic. Arch Phys Med Rehabil. 1955 Feb;36(2):74-7. No abstract available.

ReferenceCitation: Young E. Ultraviolet therapy of psoriasis: a critical study. Br J Dermatol. 1972 Oct;87(4):379-82. doi: 10.1111/j.1365-2133.1972.tb07426.x. No abstract available.

ReferenceCitation: van de Kerkhof PC. Therapeutic strategies: rotational therapy and combinations. Clin Exp Dermatol. 2001 Jun;26(4):356-61. doi: 10.1046/j.1365-2230.2001.00829.x.

ReferenceCitation: Weinstein GD, White GM. An approach to the treatment of moderate to severe psoriasis with rotational therapy. J Am Acad Dermatol. 1993 Mar;28(3):454-9. doi: 10.1016/0190-9622(93)70067-4.

ReferenceCitation: Lebwohl M. Combining the new biologic agents with our current psoriasis armamentarium. J Am Acad Dermatol. 2003 Aug;49(2 Suppl):S118-24. doi: 10.1016/s0190-9622(03)01144-7.

ReferenceCitation: Tabolli S, Calza A, Di Pietro C, Sampogna F, Abeni D. Quality of life of psoriasis patients before and after balneo -- or balneophototherapy. Yonsei Med J. 2009 Apr 30;50(2):215-21. doi: 10.3349/ymj.2009.50.2.215.

ReferenceCitation: Grob JJ, Auquier P, Martin S, Lancon C, Bonerandi JJ. Development and validation of a quality of life measurement for chronic skin disorders in french: VQ-Dermato. The ReseaudEpidemiolo gie en Dermatologie. Dermatology. 1999;199(3):213-22. doi: 10.1159/000018250.

ReferenceCitation: Hsu S, Papp KA, Lebwohl MG, Bagel J, Blauvelt A, Duffin KC, Crowley J, Eichenfield LF, Feldman SR, Fiorentino DF, Gelfand JM, Gottlieb AB, Jacobsen C, Kalb RE, Kavanaugh A, Korman NJ, Krueger GG, Michelon MA, Morison W, Ritchlin CT, Stein Gold L, Stone SP, Strober BE, Van Voorhees AS, Weiss SC, Wanat K, Bebo BF Jr; National Psoriasis Foundation Medical Board. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102. doi: 10.1001/archdermatol.2011.1410.

ReferenceCitation: Pathirana D, Ormerod AD, Saiag P, Smith C, Spuls PI, Nast A, Barker J, Bos JD, Burmester GR, Chimenti S, Dubertret L, Eberlein B, Erdmann R, Ferguson J, Girolomoni G, Gisondi P, Giunta A, Griffiths C, Honigsmann H, Hussain M, Jobling R, Karvonen SL, Kemeny L, Kopp I, Leonardi C, Maccarone M, Menter A, Mrowietz U, Naldi L, Nijsten T, Ortonne JP, Orzechowski HD, Rantanen T, Reich K, Reytan N, Richards H, Thio HB, van de Kerkhof P, Rzany B. European S3-guidelines on the systemic treatment of psoriasis vulgaris. J Eur Acad Dermatol Venereol. 2009 Oct;23 Suppl 2:1-70. doi: 10.1111/j.1468-3083.2009.03389.x. Erratum In: J Eur Acad Dermatol Venereol. 2010 Jan;24(1):117-8.

ReferenceCitation: Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 2008 Nov;159(5):997-1035. doi: 10.1111/j.1365-2133.2008.08832.x. Epub 2008 Sep 15.

ReferenceCitation: Tsai TF, Ho JC, Song M, Szapary P, Guzzo C, Shen YK, Li S, Kim KJ, Kim TY, Choi JH, Youn JI; PEARL Investigators. Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis: a phase III, randomized, placebo-controlled trial in Taiwanese and Korean patients (PEARL). J Dermatol Sci. 2011 Sep;63(3):154-63. doi: 10.1016/j.jdermsci.2011.05.005. Epub 2011 May 20.

ReferenceCitation: Shikiar R, Bresnahan BW, Stone SP, Thompson C, Koo J, Revicki DA. Validity and reliability of patient reported outcomes used in psoriasis: results from two randomized clinical trials. Health Qual Life Outcomes. 2003 Oct 8;1:53. doi: 10.1186/1477-7525-1-53.

ReferenceCitation: Shikiar R, Willian MK, Okun MM, Thompson CS, Revicki DA. The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: results of a phase II study. Health Qual Life Outcomes. 2006 Sep 27;4:71. doi: 10.1186/1477-7525-4-71.

ReferenceCitation: Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839.

ReferenceType: derived

ReferenceCitation: Beylot-Barry M, Mahe E, Rolland C, de la Breteque MA, Eychenne C, Charles J, Payen C, Machet L, Vermorel C, Foote A, Roques C, Bosson JL. Evaluation of the benefit of thermal spa therapy in plaque psoriasis: the PSOTHERMES randomized clinical trial. Int J Biometeorol. 2022 Jun;66(6):1247-1256. doi: 10.1007/s00484-022-02273-7. Epub 2022 Mar 26.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

lead_sponsor: Association Francaise pour la Recherche Thermale

collaborators:
University Hospital, Grenoble
Floralis

location_facility:
Thermes La Roche Posay
Etablissement thermal d'Uriage
Thermes de Molitg les bains
Les thermes de ST-GERVAIS
Station Thermale Avene


title: A Prospective, Multi-Center, Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Early-Stage Hepatocellular Carcinoma (HCC)

summary: The purpose of this study is to evaluate the safety and efficacy of the NanoKnife LEDC System for the treatment of early-stage hepatocellular carcinoma (HCC).

ReferenceCitation: Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1.

ReferenceCitation: Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.

ReferenceCitation: Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, Christensen E, Pagliaro L, Colombo M, Rodes J; EASL Panel of Experts on HCC. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol. 2001 Sep;35(3):421-30. doi: 10.1016/s0168-8278(01)00130-1. No abstract available.

ReferenceCitation: Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.

ReferenceCitation: Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13.

ReferenceCitation: Jonas S, Bechstein WO, Steinmuller T, Herrmann M, Radke C, Berg T, Settmacher U, Neuhaus P. Vascular invasion and histopathologic grading determine outcome after liver transplantation for hepatocellular carcinoma in cirrhosis. Hepatology. 2001 May;33(5):1080-6. doi: 10.1053/jhep.2001.23561.

ReferenceCitation: Yao FY, Ferrell L, Bass NM, Watson JJ, Bacchetti P, Venook A, Ascher NL, Roberts JP. Liver transplantation for hepatocellular carcinoma: expansion of the tumor size limits does not adversely impact survival. Hepatology. 2001 Jun;33(6):1394-403. doi: 10.1053/jhep.2001.24563.

ReferenceCitation: Lencioni R, Cioni D, Crocetti L, Franchini C, Pina CD, Lera J, Bartolozzi C. Early-stage hepatocellular carcinoma in patients with cirrhosis: long-term results of percutaneous image-guided radiofrequency ablation. Radiology. 2005 Mar;234(3):961-7. doi: 10.1148/radiol.2343040350. Epub 2005 Jan 21.

ReferenceCitation: Llovet JM, Fuster J, Bruix J. Intention-to-treat analysis of surgical treatment for early hepatocellular carcinoma: resection versus transplantation. Hepatology. 1999 Dec;30(6):1434-40. doi: 10.1002/hep.510300629.

ReferenceCitation: Yao FY, Bass NM, Nikolai B, Davern TJ, Kerlan R, Wu V, Ascher NL, Roberts JP. Liver transplantation for hepatocellular carcinoma: analysis of survival according to the intention-to-treat principle and dropout from the waiting list. Liver Transpl. 2002 Oct;8(10):873-83. doi: 10.1053/jlts.2002.34923.

lead_sponsor: Angiodynamics, Inc.

location_country: Germany Italy Spain France

location_facility: L'institut de cancerologie Gustave Roussy

location_facility: Barcelona Clinic Liver Cancer Group, Hospital Clinic i Provincial de Barcelona

location_facility: Istituto Nazionale Tumori - Fondazione Pascale

location_facility: Universitatsklinikum Magdeburg AoR, Klinik fur Radiologie und Nuklearmedizin


title: DAA-PASS: A Post-Authorisation Safety Study of Early Recurrence of Hepatocellular Carcinoma in HCV-Infected Patients After Direct-Acting Antiviral Therapy

summary: This is an independent optional sub-study parallel to TARGET-HCC (NCT02954094). The purpose of Direct-Acting Antiviral-Post Authorization Safety Study (DAA-PASS) is to investigate the impact of exposure to direct-acting antivirals (DAAs) on early recurrence of hepatocellular carcinoma (HCC) in hepatitis C virus (HCV)-infected patients following successful HCC treatment interventions.

study_type: Observational

time_perspective: Other

lead_sponsor: Target PharmaSolutions, Inc.

location_country:
Germany
Italy
United States
Spain
France

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of California - Davis Clinical Trials

location_facility: University of California - San Francisco

location_facility: Northwestern University Division of Gastroenterology and Hepatology

location_facility: Clinical Research Institute@ Methodist Dallas Medical Center

location_facility: University of Virginia Transplant Center

location_facility: Providence Health & Services Cancer Clinical Trials

location_facility: University of Florida Hepatology Research at CTRB

location_facility: University of Iowa Hospitals and Clinics

location_facility: Rutgers-Robert Wood Johnson Medical School

location_facility: Carolinas HealthCare System Center for Liver Disease

location_facility: Vanderbilt University Medical Center - GI Research Office

location_facility: University of Florida - Health Gastroenerology

location_facility: Southern Therapy and Advanced Research LLC

location_facility: University of Arkansas for Medical Sciences

location_facility: Northwell Health - Center for Liver Disease

location_facility: University of Texas Southwestern Medical Center


title: Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)

acronym: BIO-RAIDs

summary: Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points.

primary_purpose: Basic Science

ReferenceCitation: Ngo C, Samuels S, Bagrintseva K, Slocker A, Hupe P, Kenter G, Popovic M, Samet N, Tresca P, von der Leyen H, Deutsch E, Rouzier R, Belin L, Kamal M, Scholl S; RAIDs consortium http://www.raids-fp7.eu/. From prospective biobanking to precision medicine: BIO-RAIDs - an EU study protocol in cervical cancer. BMC Cancer. 2015 Nov 4;15:842. doi: 10.1186/s12885-015-1801-0.

oa_colors: green gold

evidence: oa journal (via doaj)

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

repository_institution: PubMed Central - Europe PMC

unpaywall_oa_status: gold

lead_sponsor: Institut Curie

location_country: Germany Romania Netherlands Serbia France

location_facility: Institut de Cancérologie de l'Ouest - RENE GAUDUCHEAU

location_facility: Institut de Cancérologie de Lorraine- ICL NANCY

location_facility: Spitalul Clinic Municipal "Gavril Curteanu"

location_facility: Teo Health S.A. - Spitalul Sf. Constantin

location_facility: Netherland Cancer Institute - Antoni van Leeuwenhoek (NKI-AVL)

location_facility: Institut Régional du Cancer de Montpellier - Val D'Aurelle

location_facility: Clinic for operative oncology, Institute of oncology of Vojvodina

location_facility: Institut de Cancérologie de l'Ouest - Paul Papin

location_facility: Centre Hospitalier Intercommunal de Créteil - CHI Créteil

location_facility: Institut de Cancérologie de Lorraine - ICL

intervention_type: Procedure


title: An Advanced Configuration (The Third Generation) of the DIAMOND System for the Treatment of T2DM Patients - A Randomized, Double Blind Study

acronym: RUBY

summary:
The study purpose is to demonstrate the benefit of a simplified version of the DIAMOND System (A third Generation) in comparison to a sham treatment in terms of Glycemic control, measured as A1c, FBG and Post-Prandial Glucose levels.

The study hypothesis is that HbA1c will show greater improvement in patients receiving 12 months of therapy by the DIAMOMD System than in patients not receiving this therapy.

lead_sponsor: MetaCure Limited

location_country: Netherlands France

location_facility:
Atrium Medisch Centrum
Hospital Georges Pompidou


lead_sponsor: Sanofi

summary:
To evaluate the safety and tolerability of ascending doses of subretinal injections of SAR421869 in participants with Usher syndrome type 1B.

To evaluate for possible biological activity of SAR421869.

ReferenceCitation: Zallocchi M, Binley K, Lad Y, Ellis S, Widdowson P, Iqball S, Scripps V, Kelleher M, Loader J, Miskin J, Peng YW, Wang WM, Cheung L, Delimont D, Mitrophanous KA, Cosgrove D. EIAV-based retinal gene therapy in the shaker1 mouse model for usher syndrome type 1B: development of UshStat. PLoS One. 2014 Apr 4;9(4):e94272. doi: 10.1371/journal.pone.0094272. eCollection 2014.

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Public Library of Science

location_facility:
Investigational Site Number 250001
Investigational Site Number 840001

status: Terminated

title: A Phase I/IIA Dose Escalation Safety Study of Subretinally Injected SAR421869, Administered to Patients With Retinitis Pigmentosa Associated With Usher Syndrome Type 1B

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

design_allocation: Non-Randomized


title: Randomized Non-inferiority Study Comparing a Strategy Maintaining Current Enfuvirtide-based Antiretroviral Therapy to a Strategy Replacing Enfuvirtide by an Integrase Inhibitor (Raltegravir) in HIV-1 Infected Subjects With Plasma Hiv-1 RNA Levels Below 400 Copies Per ml.ANRS 138 EASIER

acronym: EASIER

summary: Switching from enfuvirtide to raltegravir in the treatment of HIV-infected patients who sustain viral suppression with a combination therapy including enfuvirtide (or : with an enfuvirtide-based combination therapy)

ReferenceType: result

ReferenceCitation: Goldwirt L, Braun J, de Castro N, Charreau I, Barrail-Tran A, Delaugerre C, Raffi F, Lascoux-Combe C, Aboulker JP, Taburet AM, Molina JM. Switch from enfuvirtide to raltegravir lowers plasma concentrations of darunavir and tipranavir: a pharmacokinetic substudy of the EASIER-ANRS 138 trial. Antimicrob Agents Chemother. 2011 Jul;55(7):3613-5. doi: 10.1128/AAC.01827-10. Epub 2011 May 16.

ReferenceCitation: Barau C, Delaugerre C, Braun J, de Castro N, Furlan V, Charreau I, Gerard L, Lascoux-Combe C, Molina JM, Taburet AM. High concentration of raltegravir in semen of HIV-infected men: results from a substudy of the EASIER-ANRS 138 trial. Antimicrob Agents Chemother. 2010 Feb;54(2):937-9. doi: 10.1128/AAC.01261-09. Epub 2009 Dec 7.

ReferenceCitation: Delaugerre C, Charreau I, Braun J, Nere ML, de Castro N, Yeni P, Ghosn J, Aboulker JP, Molina JM, Simon F; ANRS 138 study group. Time course of total HIV-1 DNA and 2-long-terminal repeat circles in patients with controlled plasma viremia switching to a raltegravir-containing regimen. AIDS. 2010 Sep 24;24(15):2391-5. doi: 10.1097/QAD.0b013e32833d214c.

ReferenceCitation: Boulet T, Pavie J, Charreau I, Braun J, Reynes J, Morlat P, Piroth L, Spire B, Molina JM, Aboulker JP; Easier-Anrs 138 Study Group. Impact on health-related quality of life of a switch from enfuvirtide to raltegravir among multidrug-resistant HIV-1-infected patients: a randomized open-label trial (EASIER-ANRS 138). HIV Clin Trials. 2010 Sep-Oct;11(5):283-93. doi: 10.1310/hct1105-283.

ReferenceCitation: Gallien S, Delaugerre C, Charreau I, Braun J, Boulet T, Barrail-Tran A, de Castro N, Molina JM, Kuritzkes DR. Emerging integrase inhibitor resistance mutations in raltegravir-treated HIV-1-infected patients with low-level viremia. AIDS. 2011 Mar 13;25(5):665-9. doi: 10.1097/QAD.0b013e3283445834.

ReferenceCitation: Gallien S, Braun J, Delaugerre C, Charreau I, Reynes J, Jeanblanc F, Verdon R, de Truchis P, May T, Madelaine-Chambrin I, Aboulker JP, Molina JM; EASIER ANRS 138 Study Group. Efficacy and safety of raltegravir in treatment-experienced HIV-1-infected patients switching from enfuvirtide-based regimens: 48 week results of the randomized EASIER ANRS 138 trial. J Antimicrob Chemother. 2011 Sep;66(9):2099-106. doi: 10.1093/jac/dkr269. Epub 2011 Jun 28.

ReferenceCitation: Delaugerre C, Braun J, Charreau I, Delarue S, Nere ML, de Castro N, May T, Marchou B, Simon F, Molina JM, Aboulker JP; ANRS 138-EASIER study group. Comparison of resistance mutation patterns in historical plasma HIV RNA genotypes with those in current proviral HIV DNA genotypes among extensively treated patients with suppressed replication. HIV Med. 2012 Oct;13(9):517-25. doi: 10.1111/j.1468-1293.2012.01002.x. Epub 2012 Mar 14.

ReferenceCitation: de Castro N, Braun J, Charreau I, Lafeuillade A, Viard JP, Allavena C, Aboulker JP, Molina JM; EASIER ANRS 138 study group. Incidence and risk factors for liver enzymes elevations in highly treatment-experienced patients switching from enfuvirtide to raltegravir: a sub-study of the ANRS-138 EASIER trial. AIDS Res Ther. 2016 Apr 2;13:17. doi: 10.1186/s12981-016-0101-3. eCollection 2016.

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

repository_normalized: HAL

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

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

ReferenceCitation: De Castro N, Braun J, Charreau I, Pialoux G, Cotte L, Katlama C, Raffi F, Weiss L, Meynard JL, Yazdanpanah Y, Delaugerre C, Madelaine-Chambrin I, Aboulker JP, Molina JM; EASIER ANRS 138 study group. Switch from enfuvirtide to raltegravir in virologically suppressed multidrug-resistant HIV-1-infected patients: a randomized open-label trial. Clin Infect Dis. 2009 Oct 15;49(8):1259-67. doi: 10.1086/605674.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

location_facility: Service des maladies infectieuses et tropicales Hopital Saint Louis


title: Impact Pronostique d'un événement Rythmique Ventriculaire Durant le Port de la LifeVest en Post-infarctus

acronym: WICD-MI

summary: Sudden death from ventricular arrhythmia is a serious and common complication of myocardial infarction, especially with low left ventricular ejection fraction (LVEF). Implantable cardiac defibrillator (ICD) implantation is currently recommended at three months of optimal medical treatment in patients who have had a myocardial infarction and have a LVEF below 35%. This strategy indeed allows a reduction in mortality while early post-infarction implantation showed no benefit in terms of survival. However, the risk of sudden death at this period is the greatest and the temporary defibrillator vest, marketed under the name LifeVest, is now indicated in the early post-infarction period in patients with LVEF less than 35%. Indeed, the LifeVest would allow a reduction in sudden death of rhythmic origin in the first three months post-infarction. No study has yet investigated the prognostic significance of a ventricular rhythm disorder (ventricular tachycardia [VT] or ventricular fibrillation [VF]) occurring during this early and short (approximately 3 months) particular period of wearing the LifeVest: is this a random event, or is it an event predictive of a rhythmic recurrence? The aim of the study is to assess the association between the occurrence of a sustained ventricular rhythm disorder in the early post-infarction period, during the period of wearing the LifeVest (ventricular episodes detected, treated or not), and the risk of rhythmic recurrence at 12 months.

time_perspective: Retrospective

lead_sponsor: Mathieu ECHIVARD

location_facility: Clinique Cardiologique Du Nord Saint-Denis


title: Evaluation médico-économique de la Stimulation unilatérale du Sinus Carotidien Dans le Traitement de l'Hypertension artérielle résistante: Essai Multicentrique contrôlé, randomisé, Ouvert Avec évaluation d'efficacité Tensionnelle et de sécurité

acronym: ESTIM-rHTN

summary: Medico-economics assessment (cost-effectiveness) of the unilateral carotid barostimulation with Barostim NeoTM compared to usual care in patients with resistant hypertension (multicenter randomized, PROBE trial), followed-up for 12 months, with a lifetime-long modeling.

lead_sponsor: Pr Patrick ROSSIGNOL

location_facility:
HEGP
CHRU de Nancy
CHU de Poitiers
CHU de RENNES
CHU de Toulouse
CHRU de Lille
CHRU de Tours
CHU de Grenoble
APHM
Hôpital Arthur Gardiner
Clinique Pasteur
APHP -Hotel Dieu hospital
GH la Pitié Salpêtrière
CHU de Bordeaux
Hospices civils de Lyon

appel_a_projets: PRME

region: Grand Est

nom_etablissement: CHRU DE NANCY

type_etablissement: CH

acronyme: ESTIM-RHTN

titre: Evaluation médico-économique de la stimulation unilatérale du sinus carotidien dans le traitement de l'hypertension artérielle résistante: essai contrôlé, randomisé, ouvert avec évaluation d'efficacité tensionnelle et de sécurité « ESTIM-RHTN » (medico-Economic evaluation of baroreceptor STIMulation for the treatment of Resistant HyperTensioN)

discipline_principale: cardiologie

nom_porteur: Rossignol

prenom_porteur: Patrick


summary: Fruits and vegetables are rich in a variety of flavonoids with antioxidant properties. These compounds may be partially responsible for some of the positive links found between fruits and vegetables intake and higher bone mineral density in adults and children. Several animal studies have shown that consumption of onions (which are rich in quercetin), rutin (a quercetin glycoside) and resvatrol (found in red wine) inhibits ovariectomy induced bone loss in rats. One of the most studied flavonoids with respect to bone health is the soy isoflavones. However, consumption of soy products is relatively low in Western countries. One the other hand, a flavonoid such as hesperidin, found mostly in oranges is much more abundant in the Western diet. Citrus juice consumption has been demonstrated to prevent bone loss in male orchidectomized rats while specifically feeding hesperidin has been shown to prevent bone loss in ovariectomized mice and rats. However, to date no clinical prove has been obtained for these benefits.Therefore the aim of this study is to investigate the effect of hesperidin in preventing bone loss in postmenopausal women. This study is designed as a 2-year, double blind, placebo-controlled, two arm, and parallel group study. The primary outcome measure is change in bone mineral density (BMD) while the secondary outcome measures are changes in bone resorption and formation markers as well as body composition. The women are randomised to consume 2 servings of hesperidin-rich food or food without hesperidin but with the same taste & appearance (placebo). Subjects will undergo medical screening, anthropometry, physical activity, dietary assessments and BMD before randomisation into placebo or active group. Follow-up measurements are made at 3-month intervals (for blood and urine collection) and 6-month intervals for bone mineral density. Side effects are also being monitored during each visit.

lead_sponsor: Société des Produits Nestlé (SPN)

collaborators: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

collaborators: Centre de Recherche en Nutrition Humaine. Clermont-Ferrand, France

location_facility: Centre de Recherche en Nutrition Humaine. Laboratoire de Nutrition Humaine


type: EudraCT Number

title: A Phase I/II Multicenter Open-label Dose Escalation Study of HGT-1110 Administered Intrathecally in Children With Metachromatic Leukodystrophy

acronym: IDEAMLD

summary: The purpose of this study is to determine the safety of ascending doses of HGT-1110 administered by intrathecal (IT) injection for 38 weeks (20 injections) in children with metachromatic leukodystrophy (MLD).

ReferenceCitation: I Dali C, Sevin C, Krageloh-Mann I, Giugliani R, Sakai N, Wu J, Wasilewski M. Safety of intrathecal delivery of recombinant human arylsulfatase A in children with metachromatic leukodystrophy: Results from a phase 1/2 clinical trial. Mol Genet Metab. 2020 Sep-Oct;131(1-2):235-244. doi: 10.1016/j.ymgme.2020.07.002. Epub 2020 Jul 16.

oa_host_type: publisher

repositories_concat: closed

publisher_dissemination: Elsevier

ipd_sharing_description: - De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites, …)

lead_sponsor: Shire

location_country: Germany Denmark Australia Japan France

location_facility:
Center for Pediatric Clinical Studies
The Children's Hospital at Westmead
Hopital de Bicetre
Osaka University Hospital
Rigshospitalet

intervention_type: Biological


title: Analysis of Implant Placement of Patients With Distal Radius Fractures in Western Britain,

acronym: REDIRA

summary: The purpose of this study was to determine the impact of design on plate position at the level of the distal radius. Six anterior wrist plates design were analyzed relative to the watershed line using the Soong classification. A total of 2723 anterior locking plate fixation cases were analyzed and divided into six groups: Zimmer Biomet, Newclip Technics, Stryker, Synthes, Medartis and Medartis Footprint. The number of plates recorded as Soong grade 0+1 was determined for each design, then compared using the Marascuilo procedure. The Zimmer Biomet and Newclip plates were proximal to the Watershed line significantly more often than those by Synthes and Medartis Footprint. Plate position with the Medartis design was significantly more proximal to the Watershed line compared to its companion design, the Medartis Footprint plate. Plate design is a deciding factor when treating distal radial fractures, to avoid impingement when implant removal is not routinely planned.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CH de Landerneau
CH des pays de Morlaix
CHIC de Quimper
HIA Brest
CHRU de brest


title: Efficacy at 3 Months on Permanent Atrial Fibrillation in Patients Candidates to Cardiac Surgical Treatment by Epicardial, or Possibly Endocardial, Radiofrequency Ablation

summary:
The objective of the study is to evaluate the efficacy of the epicardial or endocardial radiofrequency ablation in the treatment of atrial fibrillation.

It is a multicentric, prospective, randomized, parallel, comparative, double blind study. The study principal objective is to evaluate the absence of atrial fibrillation after 3 months. The secondary objectives consist in the evaluation of the maintenance of the sinusal heart rate at one year and of the quality of life improvement

ReferenceCitation: Benussi S, Nascimbene S, Agricola E, Calori G, Calvi S, Caldarola A, Oppizzi M, Casati V, Pappone C, Alfieri O. Surgical ablation of atrial fibrillation using the epicardial radiofrequency approach: mid-term results and risk analysis. Ann Thorac Surg. 2002 Oct;74(4):1050-6; discussion 1057. doi: 10.1016/s0003-4975(02)03850-x.

ReferenceCitation: Raman JS, Ishikawa S, Power JM. Epicardial radiofrequency ablation of both atria in the treatment of atrial fibrillation: experience in patients. Ann Thorac Surg. 2002 Nov;74(5):1506-9. doi: 10.1016/s0003-4975(02)03945-0.

lead_sponsor: University Hospital, Toulouse

location_facility: Service de Chirurgie Cardio Vasculaire - Clinique Pasteur

location_facility: Service de Chirurgie Cardio-Vasculaire - Hôpital Gabriel Montpied

location_facility: Service de Chirurgie Cardio Vasculaire - CHU RANGUEIL

location_facility: Service de Chirurgie Cardio-Vasculaire - Hôpital Côte de Nacre

location_facility: Service de Chirurgie Cardio-vasculaire - CHU Dupuytren


title: Secure Self-monitoring Through a Combination of Connected Objects: Implementation in COVID-19 Patients Monitored at Home

acronym: SECURADOM

summary: Currently, COVID+ infected patients who are on ambulatory home monitoring self-assess their health status simply by completing questionnaires and measuring their temperature twice a day. The SECURADOM project proposes to facilitate the follow-up of COVID+ or suspected COVID+ infected patients, followed at home, by collecting clinical signs on a telephone application and to monitor physiological safety parameters (respiratory rate, heart rate, temperature, blood pressure, activity) using connected objects developed by the company WITHINGS. This daily monitoring, which can be transmitted by patients to the doctors in charge of their surveillance, will improve the quality and safety of home monitoring.

time_perspective: Prospective

lead_sponsor: Withings

location_facility:
CHU d'Amiens
CHU Grenoble-Alpes
Hôpital d'Instruction des Armées Percy
Hôpital d'Instruction des Armées Bégin


title: Comparison of Therapeutic Strategies With Cholinesterase Inhibitors: Stop or Still (SOS) Trial

summary:
Cholinesterase inhibitors (CI) remain the only drugs with a recognized efficacy in mild to moderate Alzheimer's disease (AD) in spite of enormous research efforts. However, these drugs presented as "symptomatic treatment" of AD are considered as having only a weak effect on the course of AD. The reimbursement of these drugs is regularly challenged due to the lack of evidence for the impact of these drugs on milestones stages of AD evolution (survival without severe dementia, restriction in Basic Activities of Daily Living - BADL) and on major consequences in public health (hospitalization and institutionalization). The great majority of previous randomized controlled trials conducted with CI have had a too short duration and the end points were limited to cognition (ADAS Cog scale), IADL (Instrumental Activities of Daily Living) function and Global Impression of Change. New evidences from the DOMINO trial (1) conducted in UK, independently of the pharmaceutical industry, showed that the true effect of CI might be more to avoid or to delay the cognitive or functional decline in AD than to improve patients; the institutionalisation (2) was also delayed. However, this trial was conducted in patients with moderate to severe AD, and the interest of the drugs at the mild to moderate stage remains questionable.

The investigators have shown that a good surrogate marker of survival without severe dementia would be an increase of ADAS Cog scale of more than six points (3). A post hoc reanalysis of the pivotal RCT with two CI showed that in mild to moderate patients, CI was associated with a 15% decrease of patients with a deterioration of ADAS-Cog of more than six points in six months. Thus at the beginning of dementia the real effect of CI might be more of delaying the cognitive and functional decline, than to improve the patients. The main objective of the SOS trial is to demonstrate that the benefit of CI at the early phase of dementia is the same as at the later phase.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU Côte de Nacre Service de neurologie et CMRR

location_facility: Centre de Recherche Clinique du Gérontopôle Cité de la Santé

location_facility: CHU de Besançon Centre Mémoire Ressources Recherche

location_facility: CHU de Clermont Ferrand Centre Mémoire Ressources Recherche

location_facility: CHRU Cavale Blanche Service de Gériatrie

location_facility: Service de Neuropsychologie Hôpital Neurologique Pierre Wertheimer

location_facility: CHU de Nantes Clinique Neurologique Hôpital GR Laennec

location_facility: CHU d'Amiens Centre Mémoire Ressources Recherche

location_facility: CHU Limoges Service de neurologie et CMRR

location_facility: APHP Groupe Hospitalier Saint Louis Lariboisière Fernand Widal CMRR

location_facility: Hospice Civil de Lyon Hôpital des Charpennes

location_facility: Chu de Strasbourg Hôpital Ka Robertsau Pôle de Gériatrie - CMRR

location_facility: Hôpital Universitaire de la Pitié Salpêtrière Pavillon François Lhermitte

location_facility: CHU de Rennes - Hôpital Pontchaillou / Service de Neurologie

location_facility: CHU Montpellier Hôpital Gui de Chauliac CMRR

location_facility: CHU Reims Hôpital Maison Blanche Court Séjour Gériatrique

location_facility: CHRU de Bretonneau Unité de gérontopsychiatrie

location_facility: Institut Claude Pompidou Centre Mémoire de Ressources et de Recherche

location_facility: CHU d'Angers Centre Mémoire Ressources Recherche

location_facility: CHU de Rouen Hôpital Charles Nicolle Service Neurologie

location_facility: CHU de Bordeaux - Service de Neurologie - Centre Mémoire Ressources Recherche -

location_facility: CHU de Bastia Centre Mémoire Ressources Recherche

status_simplified: Ongoing

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

acronyme: SOStrial

titre: Comparaison de stratégies thérapeutiques par les inhibiteurs de la cholinestérase dans la maladie d'Alzheimer : l'essai Stop ou encore (SOS)

discipline_principale: neurologie

nom_porteur: DARTIGUES

prenom_porteur: Jean François


summary: The purpose of this study is to collect long-term safety data in participants with metachromatic leukodystrophy (MLD) who are receiving HGT-1110 and have participated in Study HGT-MLD-070 (NCT01510028) through Week 40.

sponsor_collaborators: Takeda Development Center Americas, Inc.

location_facility: Center for Pediatric Clinical Studies (CPCS)

location_facility: Hopital Gui de Chauliac - CHRU de Montpellier

status: Active, not recruiting

title: An Open-Label Extension of Study HGT-MLD-070 Evaluating Long Term Safety and Efficacy of Intrathecal Administration of HGT-1110 in Patients With Metachromatic Leukodystrophy

location_country: Germany Denmark Australia Brazil Japan Czechia France


title: Evaluation of the Public Health Interest of Kaletra: Impact on Resistance to ARVs - EOLE

acronym: EOLE

summary: The purpose of this study is to evaluate, in patients in at least the second protease inhibitor (PI) line, the virological failures under Kaletra® and their consequences on protease and reverse transcriptase genotypes

lead_sponsor: Abbott

collaborators: Lincoln Medical and Mental Health Center

location_facility:
Site Reference ID/Investigator# 27800
Site Reference ID/Investigator# 27783
Site Reference ID/Investigator# 27786
Site Reference ID/Investigator# 27787
Site Reference ID/Investigator# 27798
Site Reference ID/Investigator# 27801
Site Reference ID/Investigator# 27784
Site Reference ID/Investigator# 27794
Site Reference ID/Investigator# 5595
Site Reference ID/Investigator# 27791
Site Reference ID/Investigator# 27796
Site Reference ID/Investigator# 27799
Site Reference ID/Investigator# 27792
Site Reference ID/Investigator# 27788
Site Reference ID/Investigator# 27797
Site Reference ID/Investigator# 27789
Site Reference ID/Investigator# 27802
Site Reference ID/Investigator# 27790
Site Reference ID/Investigator# 27785


summary: The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period

ReferenceCitation: Aubier M, Haughney J, Selroos O, van Schayck OC, Ekstrom T, Ostinelli J, Buhl R. Is the patient's baseline inhaled steroid dose a factor for choosing the budesonide/formoterol maintenance and reliever therapy regimen? Ther Adv Respir Dis. 2011 Oct;5(5):289-98. doi: 10.1177/1753465811407236. Epub 2011 May 17. Erratum In: Ther Adv Respir Dis. 2012 Aug;6(4):247.

ReferenceCitation: Haughney J, Aubier M, Jorgensen L, Ostinelli J, Selroos O, van Schayck CP, Buhl R. Comparing asthma treatment in elderly versus younger patients. Respir Med. 2011 Jun;105(6):838-45. doi: 10.1016/j.rmed.2011.02.011. Epub 2011 Mar 23.

ReferenceCitation: Aubier M, Buhl R, Ekstrom T, Ostinelli J, van Schayck CP, Selroos O, Haughney J. Comparison of two twice-daily doses of budesonide/formoterol maintenance and reliever therapy. Eur Respir J. 2010 Sep;36(3):524-30. doi: 10.1183/09031936.00022010. Epub 2010 Jul 1.

lead_sponsor: AstraZeneca

location_country:
Finland
Germany
Ireland
Italy
Norway
United Kingdom
Sweden
Netherlands
Belgium
Spain
Greece
Iceland
Russian Federation
France


title: A Randomised Double-blind Pilot Study Comparing Flecainide CR and Placebo in the Early Treatment of Patients With a Documented First Episode of Atrial Fibrillation.

summary: The purpose of the study is to assess the efficacy of flecainide controlled release (CR) in the prevention of recurrent AF during 9 months of active treatment compared to placebo in patients with only one documented AF episode.

lead_sponsor: MEDA Pharma GmbH & Co. KG

location_country: Germany Romania Netherlands Belgium Spain Bulgaria France

location_facility: Intensive care unit - MHATEM "Pirogov" , 21 Totleben Blvd

location_facility: Centrul de Cardiologie , Str. Tabaci No. 1

location_facility: Department of Cardiology, MHAT Burgas AD, 73 Stefan Stambolov blvd

location_facility: Klinikum Coburg , Ketschendorfer Str. 33

location_facility: Director of Electrophysiology Laboratory - Department of Medicine - Cardiology- University of Bonn, Sigmund Freud Str 25 -

location_facility: Cardiology Clinic and ICU, UMHAT "Dr. Georgi Stranski" EAD, 8a Georgi Kochev Str

location_facility: Div Cardiology; University Hospital , Leipzigen St 44 -

location_facility: Jean Claude GICHTENAERE, 8 quai du Général Leclerc

location_facility: National Cardiology Hospital EAD, 65 Konjovitza Str.

location_facility: Hôpital d'Instruction des Armées Sainte Anne, Boulevard Sainte Anne

location_facility: Department of Emergency and Intensive care, Military Medical Academy, 3 G. Sofiisky str

location_facility: Regionaal Ziekenhuis Heilig Hart, Naamsestraat 105

location_facility: CCU, University Hospital "St. Marina" , 1 Hristo Smirnenski Blvd

location_facility: Department of Internal medicine II, University hospital "Aleksandrovska" , 1 G. Sofiyski str

location_facility: Centre Hospitalier Regional, 1 rue du Friscaty

location_facility: Clinique Sainte-Elisabet, Place Louise Godin 1

location_facility: Centre Hospitalier Général, 10 rue de la Charité

location_facility: Spitalul Clinic Colentina-Departamentul Cardiologie, str. Stefan cel Mare, nr. 19-21, sector 2

location_facility: Centre Hospitalier Général, 516 avenue de Paris

location_facility: Hôpital de Freyming Merlebach- Service de Cardiologie, 2 rue de France

location_facility: Patrick GIRAUD, Bat C 132 av Gabriel Péri

location_facility: Centre Hospitalier du Leman, 3 avenue de la dame

location_facility: SPITALUL JUDETEAN-SECTIA CARDIOLOGIE, BRASOV, Str. Independentei Nr. 1

location_facility: André CORBIN, 28 rue du Conte de la Garaye

location_facility: "SPITALUL CLINIC DE URGENTA ""ELIAS""-Clinica de Cardiologie, Str. Marasti, Nr. 17, sect 1

location_facility: Résidence Médicale Les Roses, 57, route de Lavérune

location_facility: "Academisch Ziekenhuis Maastricht, P. Debyelaan 25

location_facility: Clinic of Cardiology, University Hospital 'Queen Giovanna', 8 Bialo More str

location_facility: Hospital Universitario de Getafe, Carretera de toledo

location_facility: Intensive Therapeutic Department, MHAT Ruse, 2 Nezavosimost str

location_facility: Centre Hospitalier Général, 22, boulevard Général Sibille

location_facility: Hopital d'instruction des armées, rue Colonel Fonferrier

location_facility: Zentralklinic Bad Berka Gmbr Klinic fur Kardiologie- Leitender Arzt der Avteilung - Rhythmologie und invasive Elektrophysiologie, Robert Koch Allee 9

location_facility: "SPITALUL CLINIC de RECUPERARE, Str. Viilor Nr.46-50

location_facility: Hôpital d'Arras service de cardiologie, 57 avenue Wiston Churchill

location_facility: Centre médical, Promenade du petit Languedoc

location_facility: Clinic of cardiology at Second MHAT, 120, Hristo Botev Blvd

location_facility: Oberarzt Medizinische Klinik und Poliklinik C IZKF Münster Kompetenznetzt Vorhofflimmern Universitätsklinikum Münster, Albert-Schweitzer-Straße 33,


title: Randomised Phase 3 Study of Rituximab in High-Risk Patients With Diffuse Large B-Cell Lymphoma Who Received a First-Line Consolidative Chemotherapy With Autologous Stem Cell Transplant (ASCT).

summary: Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.

ReferenceCitation: Haioun C, Lepage E, Gisselbrecht C, Salles G, Coiffier B, Brice P, Bosly A, Morel P, Nouvel C, Tilly H, Lederlin P, Sebban C, Briere J, Gaulard P, Reyes F. Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin's lymphoma: final analysis of the prospective LNH87-2 protocol--a groupe d'Etude des lymphomes de l'Adulte study. J Clin Oncol. 2000 Aug;18(16):3025-30. doi: 10.1200/JCO.2000.18.16.3025.

ReferenceCitation: Coiffier B, Haioun C, Ketterer N, Engert A, Tilly H, Ma D, Johnson P, Lister A, Feuring-Buske M, Radford JA, Capdeville R, Diehl V, Reyes F. Rituximab (anti-CD20 monoclonal antibody) for the treatment of patients with relapsing or refractory aggressive lymphoma: a multicenter phase II study. Blood. 1998 Sep 15;92(6):1927-32.

lead_sponsor: Lymphoma Study Association

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud


title: Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE)

acronym: ELEGANCE

summary: The ELEGANCE Registry's objective is to collect Real-World Data (RWD), including populations previously not represented in Peripheral Vascular Disease (PVD) trials, health economics data, and to support the safe use of commercially available Boston Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in the peripheral vasculature.

status: Recruiting

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Poland
Australia
Austria
United States
China
Spain
Thailand
Taiwan
Canada
France

location_facility: Xuanwu Hospital Capital Medical University

location_facility: Affiliated Hospital of Medical College Qingdao University

location_facility: Beijing Anzhen Hospital of the Capital University of Medical Sciences

location_facility: Rex UNC Health (NC Heart and Vascular Research, LLC)

location_facility: The First Affiliated Hospital of Chongqing Medical University

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Pinnacle Health Cardiovascular Institute

location_facility: North Shore University Hospital/Northwell Health

location_facility: St. John's Hospital/ Prairie Education and Research Cooperative

location_facility: Shanghai Ninth People's Hospital - Shanghai Jiaotong University School of Medicine

location_facility: Weill Cornell Medicine/New York-Presbyterian Hospita

location_facility: Robert Wood Johnson/Newark Beth Israel Medical Center

location_facility: Texas Tech University Health Sciences Center

location_facility: Uniwersyteckim Szpitalem Klinicznym w Poznaniu

location_facility: Monument Health Rapid City Hospital, Inc.


title: An Open-label Randomized Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating adaLimumab: The CONTROL Trial

acronym: CONTROL

summary:
PHASE: IV

DESCRIPTIVE: Randomized, interventional, open label multicenter trial

POPULATION: Moderate to severe ulcerative colitis

STUDY TREATMENTS: Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26) and could be optimized up to 80mg EOW (or 40 EW according to patient and/or investigator preference) for two months and then could be optimized up to 80mg EOW (or 40 EW according to patient and/or investigator preference) and azathioprine (2.0/2.5 mg/kg/ day) or methotrexate (25 mg EW) until V3 (W 38).

OBJECTIVES: To assess the impact of a treat to target treatment follow up by e-Monitoring and fecal calprotectin dosing at home associated to an appropriate patient education versus standard treatment follow up at W48 in patients requiring a treatment with adalimumab (Humira®).

primary_purpose: Other

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility: CHU Nîmes - Hôpital Universitaire Caremeau


type: Other Grant/Funding Number

title: Long Term (1 Year) Respiratory Sequelae in Children Surviving Acute Respiratory Distress Syndrome

summary: The purpose of this study is to assess long term (1 year) respiratory sequelae in children surviving an acute respiratory distress syndrome

ReferenceCitation: Neve V, Sadik A, Petyt L, Dauger S, Kheniche A, Denjean A, Leger PL, Chalard F, Boule M, Javouhey E, Reix P, Canterino I, Deken V, Matran R, Leteurtre S, Leclerc F. Whole pulmonary assessment 1 year after paediatric acute respiratory distress syndrome: prospective multicentre study. Ann Intensive Care. 2022 Aug 20;12(1):79. doi: 10.1186/s13613-022-01050-4.

lead_sponsor: University Hospital, Lille

location_country: Belgium France

location_facility: Hôpital Trousseau, Assistance Publique Hôpitaux de Paris

location_facility: Hôpital Jeanne de Flandre, Centre Hospitalier Régional et Universitaire de Lille

location_facility: Hôpital Necker-Enfants Malades, Assistance Publique Hôpitaux de Paris

location_facility: Hôpital Universitaire des Enfants Reine Fabiola, Université Libre de Bruxelles,

location_facility: Hôpital Robert Debré, Assistance Publique Hôpitaux de Paris


title: Bone Marrow Transplantation HLA Haploidentical After a Reduced Intensity Conditioning and Prevention of GvHD Based on Post-transplant Cyclophosphamide Administration in Patients With Severe Sickle Cell Disease

acronym: DREPHAPLO

summary: multicentric interventional biomedical research phase II, prospective, non-randomized evaluating a haploidentical marrow transplants after reduced-intensity conditioning and prevention of GvHD based on cyclophosphamide administration post transplantation in patients with severe sickle cell disease.

ReferenceCitation: Yawn BP, Buchanan GR, Afenyi-Annan AN, Ballas SK, Hassell KL, James AH, Jordan L, Lanzkron SM, Lottenberg R, Savage WJ, Tanabe PJ, Ware RE, Murad MH, Goldsmith JC, Ortiz E, Fulwood R, Horton A, John-Sowah J. Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members. JAMA. 2014 Sep 10;312(10):1033-48. doi: 10.1001/jama.2014.10517. Erratum In: JAMA. 2014 Nov 12;312(18):1932. JAMA. 2015 Feb 17;313(7):729.

ReferenceCitation: Habibi A, Arlet JB, Stankovic K, Gellen-Dautremer J, Ribeil JA, Bartolucci P, Lionnet F; centre de reference maladies rares << syndromes drepanocytaires majeurs >>. [French guidelines for the management of adult sickle cell disease: 2015 update]. Rev Med Interne. 2015 May 11;36(5 Suppl 1):5S3-84. doi: 10.1016/S0248-8663(15)60002-9. French.

ReferenceCitation: Lanzkron S, Carroll CP, Haywood C Jr. Mortality rates and age at death from sickle cell disease: U.S., 1979-2005. Public Health Rep. 2013 Mar-Apr;128(2):110-6. doi: 10.1177/003335491312800206.

ReferenceCitation: Bernaudin F, Socie G, Kuentz M, Chevret S, Duval M, Bertrand Y, Vannier JP, Yakouben K, Thuret I, Bordigoni P, Fischer A, Lutz P, Stephan JL, Dhedin N, Plouvier E, Margueritte G, Bories D, Verlhac S, Esperou H, Coic L, Vernant JP, Gluckman E; SFGM-TC. Long-term results of related myeloablative stem-cell transplantation to cure sickle cell disease. Blood. 2007 Oct 1;110(7):2749-56. doi: 10.1182/blood-2007-03-079665. Epub 2007 Jul 2.

ReferenceCitation: Kuentz M, Robin M, Dhedin N, Hicheri Y, Peffault de Latour R, Rohrlich P, Bordigoni P, Bruno B, Socie G, Bernaudin F. Is there still a place for myeloablative regimen to transplant young adults with sickle cell disease? Blood. 2011 Oct 20;118(16):4491-2; author reply 4492-3. doi: 10.1182/blood-2011-07-367490. No abstract available.

ReferenceCitation: Angelucci E, Matthes-Martin S, Baronciani D, Bernaudin F, Bonanomi S, Cappellini MD, Dalle JH, Di Bartolomeo P, de Heredia CD, Dickerhoff R, Giardini C, Gluckman E, Hussein AA, Kamani N, Minkov M, Locatelli F, Rocha V, Sedlacek P, Smiers F, Thuret I, Yaniv I, Cavazzana M, Peters C; EBMT Inborn Error and EBMT Paediatric Working Parties. Hematopoietic stem cell transplantation in thalassemia major and sickle cell disease: indications and management recommendations from an international expert panel. Haematologica. 2014 May;99(5):811-20. doi: 10.3324/haematol.2013.099747.

ReferenceCitation: Hsieh MM, Fitzhugh CD, Weitzel RP, Link ME, Coles WA, Zhao X, Rodgers GP, Powell JD, Tisdale JF. Nonmyeloablative HLA-matched sibling allogeneic hematopoietic stem cell transplantation for severe sickle cell phenotype. JAMA. 2014 Jul 2;312(1):48-56. doi: 10.1001/jama.2014.7192.

ReferenceCitation: Bolanos-Meade J, Fuchs EJ, Luznik L, Lanzkron SM, Gamper CJ, Jones RJ, Brodsky RA. HLA-haploidentical bone marrow transplantation with posttransplant cyclophosphamide expands the donor pool for patients with sickle cell disease. Blood. 2012 Nov 22;120(22):4285-91. doi: 10.1182/blood-2012-07-438408. Epub 2012 Sep 6.

ReferenceCitation: Kamani NR, Walters MC, Carter S, Aquino V, Brochstein JA, Chaudhury S, Eapen M, Freed BM, Grimley M, Levine JE, Logan B, Moore T, Panepinto J, Parikh S, Pulsipher MA, Sande J, Schultz KR, Spellman S, Shenoy S. Unrelated donor cord blood transplantation for children with severe sickle cell disease: results of one cohort from the phase II study from the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). Biol Blood Marrow Transplant. 2012 Aug;18(8):1265-72. doi: 10.1016/j.bbmt.2012.01.019. Epub 2012 Feb 16.

ReferenceCitation: Luznik L, O'Donnell PV, Symons HJ, Chen AR, Leffell MS, Zahurak M, Gooley TA, Piantadosi S, Kaup M, Ambinder RF, Huff CA, Matsui W, Bolanos-Meade J, Borrello I, Powell JD, Harrington E, Warnock S, Flowers M, Brodsky RA, Sandmaier BM, Storb RF, Jones RJ, Fuchs EJ. HLA-haploidentical bone marrow transplantation for hematologic malignancies using nonmyeloablative conditioning and high-dose, posttransplantation cyclophosphamide. Biol Blood Marrow Transplant. 2008 Jun;14(6):641-50. doi: 10.1016/j.bbmt.2008.03.005.

ReferenceCitation: McCurdy SR, Kanakry JA, Showel MM, Tsai HL, Bolanos-Meade J, Rosner GL, Kanakry CG, Perica K, Symons HJ, Brodsky RA, Gladstone DE, Huff CA, Pratz KW, Prince GT, Dezern AE, Gojo I, Matsui WH, Borrello I, McDevitt MA, Swinnen LJ, Smith BD, Levis MJ, Ambinder RF, Luznik L, Jones RJ, Fuchs EJ, Kasamon YL. Risk-stratified outcomes of nonmyeloablative HLA-haploidentical BMT with high-dose posttransplantation cyclophosphamide. Blood. 2015 May 7;125(19):3024-31. doi: 10.1182/blood-2015-01-623991. Epub 2015 Mar 26.

ReferenceCitation: Bashey A, Zhang X, Sizemore CA, Manion K, Brown S, Holland HK, Morris LE, Solomon SR. T-cell-replete HLA-haploidentical hematopoietic transplantation for hematologic malignancies using post-transplantation cyclophosphamide results in outcomes equivalent to those of contemporaneous HLA-matched related and unrelated donor transplantation. J Clin Oncol. 2013 Apr 1;31(10):1310-6. doi: 10.1200/JCO.2012.44.3523. Epub 2013 Feb 19.

ReferenceCitation: Bashey A, Zhang X, Jackson K, Brown S, Ridgeway M, Solh M, Morris LE, Holland HK, Solomon SR. Comparison of Outcomes of Hematopoietic Cell Transplants from T-Replete Haploidentical Donors Using Post-Transplantation Cyclophosphamide with 10 of 10 HLA-A, -B, -C, -DRB1, and -DQB1 Allele-Matched Unrelated Donors and HLA-Identical Sibling Donors: A Multivariable Analysis Including Disease Risk Index. Biol Blood Marrow Transplant. 2016 Jan;22(1):125-33. doi: 10.1016/j.bbmt.2015.09.002. Epub 2015 Sep 7.

ReferenceCitation: Ciurea SO, Mulanovich V, Saliba RM, Bayraktar UD, Jiang Y, Bassett R, Wang SA, Konopleva M, Fernandez-Vina M, Montes N, Bosque D, Chen J, Rondon G, Alatrash G, Alousi A, Bashir Q, Korbling M, Qazilbash M, Parmar S, Shpall E, Nieto Y, Hosing C, Kebriaei P, Khouri I, Popat U, de Lima M, Champlin RE. Improved early outcomes using a T cell replete graft compared with T cell depleted haploidentical hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2012 Dec;18(12):1835-44. doi: 10.1016/j.bbmt.2012.07.003. Epub 2012 Jul 11.

ReferenceCitation: Raiola AM, Dominietto A, Ghiso A, Di Grazia C, Lamparelli T, Gualandi F, Bregante S, Van Lint MT, Geroldi S, Luchetti S, Ballerini F, Miglino M, Varaldo R, Bacigalupo A. Unmanipulated haploidentical bone marrow transplantation and posttransplantation cyclophosphamide for hematologic malignancies after myeloablative conditioning. Biol Blood Marrow Transplant. 2013 Jan;19(1):117-22. doi: 10.1016/j.bbmt.2012.08.014. Epub 2012 Aug 29.

ReferenceCitation: Kanakry CG, Ganguly S, Zahurak M, Bolanos-Meade J, Thoburn C, Perkins B, Fuchs EJ, Jones RJ, Hess AD, Luznik L. Aldehyde dehydrogenase expression drives human regulatory T cell resistance to posttransplantation cyclophosphamide. Sci Transl Med. 2013 Nov 13;5(211):211ra157. doi: 10.1126/scitranslmed.3006960.

ReferenceCitation: Ganguly S, Ross DB, Panoskaltsis-Mortari A, Kanakry CG, Blazar BR, Levy RB, Luznik L. Donor CD4+ Foxp3+ regulatory T cells are necessary for posttransplantation cyclophosphamide-mediated protection against GVHD in mice. Blood. 2014 Sep 25;124(13):2131-41. doi: 10.1182/blood-2013-10-525873. Epub 2014 Aug 18.

ReferenceCitation: Stem Cell Trialists' Collaborative Group. Allogeneic peripheral blood stem-cell compared with bone marrow transplantation in the management of hematologic malignancies: an individual patient data meta-analysis of nine randomized trials. J Clin Oncol. 2005 Aug 1;23(22):5074-87. doi: 10.1200/JCO.2005.09.020.

ReferenceCitation: Yang JZ, Zhang JQ, Sun LX. Mechanisms for T cell tolerance induced with granulocyte colony-stimulating factor. Mol Immunol. 2016 Feb;70:56-62. doi: 10.1016/j.molimm.2015.12.006. Epub 2015 Dec 17.

ReferenceCitation: Jun HX, Jun CY, Yu ZX. In vivo induction of T-cell hyporesponsiveness and alteration of immunological cells of bone marrow grafts using granulocyte colony-stimulating factor. Haematologica. 2004 Dec;89(12):1517-24.

ReferenceCitation: Deotare U, Al-Dawsari G, Couban S, Lipton JH. G-CSF-primed bone marrow as a source of stem cells for allografting: revisiting the concept. Bone Marrow Transplant. 2015 Sep;50(9):1150-6. doi: 10.1038/bmt.2015.80. Epub 2015 Apr 27.

ReferenceCitation: Couban S, Messner HA, Andreou P, Egan B, Price S, Tinker L, Meharchand J, Forrest DL, Lipton J. Bone marrow mobilized with granulocyte colony-stimulating factor in related allogeneic transplant recipients: a study of 29 patients. Biol Blood Marrow Transplant. 2000;6(4A):422-7. doi: 10.1016/s1083-8791(00)70033-4.

ReferenceCitation: Isola L, Scigliano E, Fruchtman S. Long-term follow-up after allogeneic granulocyte colony-stimulating factor--primed bone marrow transplantation. Biol Blood Marrow Transplant. 2000;6(4A):428-33. doi: 10.1016/s1083-8791(00)70034-6.

ReferenceCitation: Ji SQ, Chen HR, Wang HX, Yan HM, Pan SP, Xun CQ. Comparison of outcome of allogeneic bone marrow transplantation with and without granulocyte colony-stimulating factor (lenograstim) donor-marrow priming in patients with chronic myelogenous leukemia. Biol Blood Marrow Transplant. 2002;8(5):261-7. doi: 10.1053/bbmt.2002.v8.pm12064363.

ReferenceCitation: Morton J, Hutchins C, Durrant S. Granulocyte-colony-stimulating factor (G-CSF)-primed allogeneic bone marrow: significantly less graft-versus-host disease and comparable engraftment to G-CSF-mobilized peripheral blood stem cells. Blood. 2001 Dec 1;98(12):3186-91. doi: 10.1182/blood.v98.12.3186.

ReferenceCitation: Serody JS, Sparks SD, Lin Y, Capel EJ, Bigelow SH, Kirby SL, Gabriel DA, Wiley JM, Brecher ME, Schell MJ, Folds J, Shea TC. Comparison of granulocyte colony-stimulating factor (G-CSF)--mobilized peripheral blood progenitor cells and G-CSF--stimulated bone marrow as a source of stem cells in HLA-matched sibling transplantation. Biol Blood Marrow Transplant. 2000;6(4A):434-40. doi: 10.1016/s1083-8791(00)70035-8.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

collaborators: Association Clinique Thérapeutique Infantile du val de Marne

location_facility:
Hospital Necker
CHU Henri-Mondor
Hospital Robert-Debré
CHU La Timone
Saint-Louis hospital
intercommunal hospital of Créteil
CHU Strasbourg


title: Ability of the Analgesia Nociception Index Monitor to Distinguish Between Excessive Analgesia and Inadvertent Parasympathetic Nerve Stimulation During Surgery of Large Cerebellopontine Angle Tumours

acronym: ANI

summary:
Surgery of large cerebellopontine angle (CPA) tumors (>2 x 2 cm diameter), with compression of the pons exposes the patient to inadvertent parasympathetic nerve stimulation (IPNS) leading to bradycardia and asystole.

The analgesia nociception index (ANI) monitor assesses the balance between analgesia and nociception through the detection of parasympathetic tone. ANI >80 generally denotes excessive analgesia (EA). The main objective of this study was to determine whether ANI values for IPNS are different or the same as ANI values for EA. This study also aims at calculating the number of patients with IPNS and EA during surgery of large CPA tumours.

ReferenceCitation: Renowden S. Imaging of the cerebello-pontine angle. Pract Neurol. 2014 Oct;14(5):e2. doi: 10.1136/practneurol-2014-000949. Epub 2014 Aug 12. No abstract available.

ReferenceCitation: Sesay M, Vignes JR, Stockle M, Mehsen M, Boulard G, Maurette P. [Spectral analysis of the ECG R-R interval permits early detection of vagal responses to neurosurgical stimuli]. Ann Fr Anesth Reanim. 2003 May;22(5):421-4. doi: 10.1016/s0750-7658(03)00094-7. French.

ReferenceCitation: De Jonckheere J, Rommel D, Nandrino JL, Jeanne M, Logier R. Heart rate variability analysis as an index of emotion regulation processes: interest of the Analgesia Nociception Index (ANI). Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:3432-5. doi: 10.1109/EMBC.2012.6346703.

ReferenceCitation: Jeanne M, Clement C, De Jonckheere J, Logier R, Tavernier B. Variations of the analgesia nociception index during general anaesthesia for laparoscopic abdominal surgery. J Clin Monit Comput. 2012 Aug;26(4):289-94. doi: 10.1007/s10877-012-9354-0. Epub 2012 Mar 28.

ReferenceCitation: Robin F, Sesay M, Kolanek B, Pena D, Penna M, Morel-Locket L et al. The analgesia nociception index monitor (ANI) can detect indvertent vagal stimulation during surgery of cerebello-pontine angle tumors. Br J Anaesth 2013;111: https: // doi.org/10.1093/bja/el_10195

ReferenceCitation: Kommula LK, Bansal S, Umamaheswara Rao GS. Analgesia Nociception Index Monitoring During Supratentorial Craniotomy. J Neurosurg Anesthesiol. 2019 Jan;31(1):57-61. doi: 10.1097/ANA.0000000000000464.

ReferenceCitation: Theerth KA, Sriganesh K, Reddy KM, Chakrabarti D, Umamaheswara Rao GS. Analgesia Nociception Index-guided intraoperative fentanyl consumption and postoperative analgesia in patients receiving scalp block versus incision-site infiltration for craniotomy. Minerva Anestesiol. 2018 Dec;84(12):1361-1368. doi: 10.23736/S0375-9393.18.12837-9. Epub 2018 Jul 9.

ReferenceCitation: Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.

ReferenceCitation: Galley HF. Editorial II: Solid as a ROC. Br J Anaesth. 2004 Nov;93(5):623-6. doi: 10.1093/bja/aeh247. No abstract available.

lead_sponsor: Association de Developpement de la Neuroanesthesie Reanimation


title: Evolution of Empathy and Emotional Intelligence During a Doctor-patient Relationship Training for 4th Year Medical Students

acronym: EMOREL

summary:
Background: Empathic skills of medical students decrease during their studies. Besides, communication skills training is French context. In this context doctor-patient relationship training was built at Paris Descartes University for the 4th year medical students. Implementation of this training aims at maintaining or even increasing empathic and emotional skills of students.

Objective: to evaluate effectiveness of this training on medical students skills, knowledge and attitudes.

Methodology: Interventional and longitudinal monocentric study Pre/post-test auto-assessment for

empathic skills score assessed with the Jefferson Scale of Physician Empathy- Medical Student Version (JSPE-MS)
emotional intelligence's score assessed with the Emotional Expressivity Scale (EES)
students' declarative knowledge of the doctor-patient relationship assessed with multiple choice question.

Post-test assessement for:

empathic skills assessed by simulated patients with CARE grid during the Objective Structured Clinical Examination (OSCE).
satisfaction auto-questionnaire.
socio-demographic and education data.

ReferenceCitation: Parish JM. The Patient Will See You Now: The Future of Medicine is in Your Hands. J Clin Sleep Med. 2015 Mar 20:jc-00119-15. Online ahead of print. No abstract available.

ReferenceCitation: Richard C, Lussier M-T. La communication professionnelle en santé: Erpi; 2016.

ReferenceCitation: Starfield B, Wray C, Hess K, Gross R, Birk PS, D'Lugoff BC. The influence of patient-practitioner agreement on outcome of care. Am J Public Health. 1981 Feb;71(2):127-31. doi: 10.2105/ajph.71.2.127.

ReferenceCitation: Maguire P, Fairbairn S, Fletcher C. Consultation skills of young doctors: I--Benefits of feedback training in interviewing as students persist. Br Med J (Clin Res Ed). 1986 Jun 14;292(6535):1573-6. doi: 10.1136/bmj.292.6535.1573. Erratum In: Br Med J (Clin Res Ed) 1986 Jul 5;293(6538):26.

ReferenceCitation: Beckman HB, Markakis KM, Suchman AL, Frankel RM. The doctor-patient relationship and malpractice. Lessons from plaintiff depositions. Arch Intern Med. 1994 Jun 27;154(12):1365-70.

ReferenceCitation: Marvel MK, Epstein RM, Flowers K, Beckman HB. Soliciting the patient's agenda: have we improved? JAMA. 1999 Jan 20;281(3):283-7. doi: 10.1001/jama.281.3.283.

ReferenceCitation: Ormel J, Koeter MW, van den Brink W, van de Willige G. Recognition, management, and course of anxiety and depression in general practice. Arch Gen Psychiatry. 1991 Aug;48(8):700-6. doi: 10.1001/archpsyc.1991.01810320024004.

ReferenceCitation: Arborelius E, Bremberg S. What does a human relationship with the doctor mean? Scand J Prim Health Care. 1992 Sep;10(3):163-9. doi: 10.3109/02813439209014056.

ReferenceCitation: Beaulieu MD, Leclere H, Bordage G. Taxonomy of difficulties in general practice. Can Fam Physician. 1993 Jun;39:1369-75.

ReferenceCitation: Novel A-S. Baptiste Beaulieu : " J'ai parfois l'impression que ma vie passe sans moi ". Le Monde.27.03.2015

ReferenceCitation: DiMatteo MR, Haskard-Zolnierek KB, Martin LR. Improving patient adherence: a three-factor model to guide practice. Health Psychology Review. 2012;6(1):74-91.

ReferenceCitation: DiMatteo MR. The physician-patient relationship: effects on the quality of health care. Clin Obstet Gynecol. 1994 Mar;37(1):149-61. doi: 10.1097/00003081-199403000-00019. No abstract available.

ipd_sharing_description: All data will be shared with research team.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
University of Paris 5 - Rene Descartes

location_facility: Paris Descartes University, Sorbonne Paris City, Faculty of Medicine


title: Prospective Study of ACVBP Followed by Autologous Stem Cell Transplantation in Case of BCL-2 Overexpression in Non Previously Treated Patients Aged 60 Years or Less With Low-Intermediate Risk Diffuse Large B-Cell Lymphoma

summary: The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in case of bcl-2 overexpression in non previously treated patients aged 60 years or less with low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal is to obtain a 15% increase of event-free survival at 2 years.

sponsor_collaborators:
Lymphoma Study Association
Fondation ARC

location_facility:
Service d'Hematologie
Hôpital Henri Mondor
Hôpital Saint Louis
Centre Hospitalier Lyon Sud
Centre Henri Becquerel


title: Development of an Artificial Intelligence Model of Image Recognition Through Images of Intravascular Catheters From Inpatients and Outpatients to Identify the Presence of Local Signs Associated With Infection

acronym: DeepCath

summary:
Deepcath is the first step to the introduction of artificial intelligence in catheter care. A better use of visualisation of catheter exit site should be used not only by the HCWs but also by the patients and their family.

A deep learning system able to detect visual abnormalities of the catheter exit site will be an helpful tools to develop a continuous follow-up of intravascular catheters.

ReferenceCitation: Timsit JF, Schwebel C, Bouadma L, Geffroy A, Garrouste-Orgeas M, Pease S, Herault MC, Haouache H, Calvino-Gunther S, Gestin B, Armand-Lefevre L, Leflon V, Chaplain C, Benali A, Francais A, Adrie C, Zahar JR, Thuong M, Arrault X, Croize J, Lucet JC; Dressing Study Group. Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults: a randomized controlled trial. JAMA. 2009 Mar 25;301(12):1231-41. doi: 10.1001/jama.2009.376.

ReferenceCitation: Timsit JF. Diagnosis and prevention of catheter-related infections. Curr Opin Crit Care. 2007 Oct;13(5):563-71. doi: 10.1097/MCC.0b013e3282efa03f.

ReferenceCitation: Buetti N, Rickard CM, Timsit JF. Catheter dressings. Intensive Care Med. 2022 Aug;48(8):1066-1068. doi: 10.1007/s00134-022-06734-w. Epub 2022 May 27. No abstract available.

evidence: open (via free pdf)

unpaywall_oa_status: bronze

ReferenceCitation: Blot S, Ruppe E, Harbarth S, Asehnoune K, Poulakou G, Luyt CE, Rello J, Klompas M, Depuydt P, Eckmann C, Martin-Loeches I, Povoa P, Bouadma L, Timsit JF, Zahar JR. Healthcare-associated infections in adult intensive care unit patients: Changes in epidemiology, diagnosis, prevention and contributions of new technologies. Intensive Crit Care Nurs. 2022 Jun;70:103227. doi: 10.1016/j.iccn.2022.103227. Epub 2022 Mar 3.

oa_colors: green other

evidence: open (via free article)

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Geneva - Archive ouverte UNIGE

ReferenceCitation: Buetti N, Mermel LA, Timsit JF. Routine catheter-tip cultures for assessing catheter-related bloodstream infections in randomised-controlled trials. Anaesth Crit Care Pain Med. 2022 Feb;41(1):101006. doi: 10.1016/j.accpm.2021.101006. Epub 2021 Dec 14. No abstract available.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Buetti N, Abbas M, Pittet D, Chraiti MN, Sauvan V, De Kraker MEA, Boisson M, Teixeira D, Zingg W, Harbarth S. Lower risk of peripheral venous catheter-related bloodstream infection by hand insertion. Antimicrob Resist Infect Control. 2022 Jun 3;11(1):80. doi: 10.1186/s13756-022-01117-8.

repository_institution: Imperial College London - Spiral

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

collaborators: National Network Surveillance and Prevention of Infections Associated with Invasive Devices SPIADI

location_facility:
CHU Grenoble Alpes
Réseau RéPIAS SPIADI
CHU Clermont-Ferrand
Hôpital Bichat - Claude-Bernard


title: Pilot Study to Assess Effects of Two Herbal Dietary Supplements on Lipid Metabolism in Moderate Hypercholesterolemia and Hypertriglyceridemia

acronym: Lipiback

summary: This study is designed as a pilot study in order to estimate the effect of VAL070-A and VAL070-B products and their variability on LDL cholesterol and lipid metabolism since these data are still unknown for these products and in this specific population. Collected data will provide more reliable information which may be used to plan a subsequent larger main study.

ipd_sharing: Undecided

lead_sponsor: Valbiotis

sponsor_collaborators:
Valbiotis
Biofortis Mérieux NutriSciences

location_facility: Biofortis Mérieux NutriSciences Clinical Investigation Center

intervention_type: Dietary Supplement


title: Observational Study of the Physical Capacity of Patients With Multiple Sclerosis and Evaluation of the Effects of Usual Rehabilitation in the Day Hospital

acronym: REHABSEP

summary: The purpose of this study is to assess the physical capacity of patients with multiple sclerosis and the effects of rehabilitation, encompassing physical therapy and physical activity as it is carried out in the day hospital of (the Physical and Rehabilitation Medicine department) at Garches Hospital. We will compare the results of assessments carried out before and after a standard rehabilitation program.

ReferenceCitation: Hameau S, Bensmail D, Roche N, Zory R. Fatigability in Patients With Multiple Sclerosis During Maximal Concentric Contractions. Arch Phys Med Rehabil. 2017 Jul;98(7):1339-1347. doi: 10.1016/j.apmr.2016.12.014. Epub 2017 Jan 25.

oa_host_type: closed


title: A Two-period, Multicenter, Randomized, Open-label, Phase II Study Evaluating the Clinical Benefit of a Maintenance Treatment Targeting Tumor Molecular Alterations in Patients With Progressive Locally-advanced or Metastatic Solid Tumors

acronym: MOST plus

summary:
The MOST Plus study is a two-period phase II clinical trial, conducted in patients with all types of progressive solid tumors after at least 1 prior systemic treatment regimen for advanced disease (in the absence of a validated second line therapy).

The main goal of this study is to evaluate for these patients the clinical benefit of a maintenance treatment in patients with stable disease (SD) after induction treatment with a selected therapy (Molecular Targeted Therapy (MTT) or with SD, partial response (PR) or complete reponse (CR) with Immunotherapy (IT)).

For MTT, the first period of this trial (induction period) will enable to establish whether the identification of genomic alterations in genes encoding for "actionable" targets in the tumor cells, regardless of the histological subtype, can be used to select efficient treatment targeting the pathway activated by the mutation.

For Immunotherapy, induction period with durvalumab + tremelimumab is expected to be an innovative therapy for an efficient tumor control and may allow to identify types of cancer or molecular types of cancer that are more receptive to immunotherapy.

For all treatments, the second period (maintenance period) will use a randomized design to evaluate the clinical benefit of a maintenance treatment with the targeted therapy or immunotherapy selected based on tumor molecular profile in patients treated by MTT with SD and in patients treated by IT with SD, PR or CR.

Each patient enrolled will receive the matching targeted therapy during 12 weeks (MTT) or 52 weeks (IT). At the end of this induction period:

MTT cohorts :

patients with a tumor response (CR: complete response or PR: partial response) will continue the targeted therapy,
patients in progression will discontinue the targeted therapy and will be withdrawn from study and oriented towards standard treatments
patients with a stable disease at 12 weeks will be randomized in order to determine if they continue or stop the therapy.

IT cohort :

- patients with SD, PR or CR at 52 weeks will be randomized in order to determine if they continue or stop the therapy.

For each MTT treatment group: ~80 patients treated in the first step (induction period), 50 patients randomized in the second step (maintenance period, 25 patients per arm).

For IT treatment group: ~125 patients treated in the first step (induction period), 50 patients randomized in the second step (maintenance period, 25 patients per arm).

In total (for 7 treatment groups): ~ 600 patients treated in the induction period and 350 patients randomized in maintenance period.

lead_sponsor: Centre Leon Berard

sponsor_collaborators:
Centre Leon Berard
National Cancer Institute, France

location_facility: Institut de Cancerologie de Strasbourg Europe


title: Arterial Oxygenation During Hypoxia : Effects of an Added Expiratory Resistance

acronym: hypex

summary: Altitude tolerance correlates with the level of oxygenation achieved. The aim of the present study is to investigate whether increased expiratory pressure within the thorax is able to improve oxygenation during hypoxic hypoxia.

lead_sponsor: AGIR à Dom


title: Efficacy and Safety of Maintenance Neoral Compared to Bitherapy Neoral-Imurel or Neoral-CellCept in Renal Transplantation

summary: We have previously defined factors that predict the long term success of maintenance CsA monotherapy (CsAm) after kidney transplantation : donor age < 40 years, serum creatinine level at the initiation of CsAm £ 125 µmol/L, no rejection episode before CsAm initiation. We have also shown that the 8-year graft survival in 329 selected patients enrolled in maintenance CsA-m was 84 % (Hurault de Ligny et al, Transplantation, 2000 ; 69 : 1327-1332). These results were obtained with an old formulation of cyclosporin, azathioprine, steroid withdrawal over the first year and induction antibody. This prospective randomized multicentre study was designed to clarify whether maintenance Neoral + MMF or Neoral + AZA is better than a CsAm and wether Neoral + MMF is better than Neoral + AZA in low immunological risk cadaveric kidney transplant recipients.

ReferenceCitation: Hurault de Ligny B, Toupance O, Lavaud S, Bauwens M, Peyronnet P, Le Meur Y, Ryckelynck JP, Jolly D, Leroux-Robert C, Touchard G. Factors predicting the long-term success of maintenance cyclosporine monotherapy after kidney transplantation. Transplantation. 2000 Apr 15;69(7):1327-32. doi: 10.1097/00007890-200004150-00019.

ReferenceCitation: Touchard G, Hauet T, Cogny Van Weydevelt F, Hurault de Ligny B, Peyronnet P, Lebranchu Y, Toupance O, N'Doye P, Busson M. Maintenance cyclosporin monotherapy after renal transplantation--clinical predictors of long-term outcome. Nephrol Dial Transplant. 1997 Sep;12(9):1956-60. doi: 10.1093/ndt/12.9.1956.

lead_sponsor: Poitiers University Hospital

location_facility:
Reims University Hospital
Dupuytren University Hospital
Caen university Hospital
Poitiers University hospital
Rouen University Hospital


title: Evaluation de la réalité Virtuelle Pour réduire l'anxiété, la Douleur et de la durée d'Une Fibroscopie Bronchique Vigile Non Urgente en Soins Critiques

acronym: AVATAR

summary: Bronchial fibroscopy (BF) is a routine practice examination in critical care areas. It can be useful either for the diagnosis of the causal pathology of respiratory distress or for the diagnosis of lung infection, sometimes nosocomial. In patients in spontaneous and conscious ventilation, BF are performed vigil after local anesthesia according to the recommendations of the Société de Pneumologie de langue Française. The good tolerance of the examination and its good conduct may require the use of anxiolytics, sedatives or analgesics to limit the traumatic experience of a highly anxiety-provoking examination. Virtual reality (VR) combines a set of paramedical techniques (hypnosis, music therapy, sophrology) and is now a non-drug alternative to improve the tolerance of certain invasive gestures.VR has been shown to reduce pain and anxiety during first pathways placement or digestive endoscopies. To date, there is no evidence of the benefit of VR when performing semi-urgent BF in critical care areas.

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France

location_facility: Hôpital européen Georges Pompidou - AP-HP


title: Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients. A Prospective, Multicentric, Randomized, Controlled Trial.

acronym: PRECI-Surg

summary: In patients with type 2 diabetes, Roux-en-Y gastric bypass (RYGB), which excludes a portion of the stomach and the proximal intestine from the alimentary circuit, improves glucose metabolism more rapidly and more extensively than is expected from weight loss. The mechanisms of this unique effect of gastrointestinal exclusion appear to be complex and have not yet been clarified. A recent study unveil that intestinal uptake of ingested glucose is diminished by RYGB and restricted to the common limb, where food meets bile and other digestive fluids, resulting in an overall decrease of post prandial blood glucose excursion. the hypothesize that reducing the length of the common limb, which is rarely measured and highly variable in clinical practice, may significantly affect the metabolic outcome of gastrointestinal surgical procedures. The aim of the present study is to compare the impact of two variants of Roux-en-Y gastric bypass with a short common limb, the long alimentary limb or the long biliary limb Roux-en-Y gastric bypass, on type 2 diabetes remission in severely obese patients.

sponsor_collaborators:
University Hospital, Lille
Ministry of Health, France

location_facility:
Hop Claude Huriez Chu Lille
Chu Amiens Picardie
Ch Boulogne-Sur-Me
Ch de Valenciennes

appel_a_projets: PHRCI

region: Hauts-de-France

nom_etablissement: CHR LILLE

acronyme: PRECISurg

titre: Impact de la longueur de l'anse alimentaire sur le taux de rémission du diabète de type 2 après gastric bypass chez le patient obèse sévère - Essai clinique contrôlé, multicentrique, randomisé

discipline_principale: gastric by-pass, diabète de type 2, obésité, rémission, anse alimentaire longue

nom_porteur: BAUD

prenom_porteur: Grégory


title: Transcranial Direct Current Stimulation (tDCS) to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder

acronym: tDCS-TOC

summary: It's a multicentric, randomized, controlled study concerning 100 patients with treatment-resistant obsessive compulsive disorders (OCD). The aim of this study is to evaluate the effect of transcranial direct current stimulation (tDCS) on OCD patients.

lead_sponsor: Centre Hospitalier Henri Laborit

sponsor_collaborators:
Centre Hospitalier Henri Laborit
Ministry of Health, France

location_facility:
Hospices Civils De Lyon
CHU de Nantes
Centre Hospitalier Henri Laborit
C.H. Guillaume Regnier

nom_etablissement: CTRE HOSPITALIER HENRI LABORIT

type_etablissement: EPSM

acronyme: tDCS-TOC

titre: Stimulation transcrânienne directe à courant continu chez les patients souffrant de trouble obsessionnel compulsif sévère résistant

discipline_principale: autre

nom_porteur: HEIT

prenom_porteur: Damien


title: Efficacy of Transcutaneous Electrical Nerve Stimulation in the Improvement of Walking Distance in Patients With Peripheral Artery Disease With Intermittent Claudication

acronym: TENS-PAD

summary: Purpose: The investigators team recently carried out a proof of concept study testing the efficacy of one single 45-minute session of 10 Hz TENS prior to walking, versus placebo. In this randomized study, the investigators found that TENS significantly delayed pain onset and increased the pain-free walking distance in patients with class II PAD. From these encouraging results, the investigators now seek to assess the efficacy of an intervention that includes the daily use of TENS for 3 weeks (5 days a week) on walking distance in PAD (Leriche-Fontaine stage II). Methods/Design: prospective multicentre study / randomized controlled trial / double blinding.

ReferenceCitation: Besnier F, Senard JM, Gremeaux V, Riedel M, Garrigues D, Guiraud T, Labrunee M. The efficacy of transcutaneous electrical nerve stimulation on the improvement of walking distance in patients with peripheral arterial disease with intermittent claudication: study protocol for a randomised controlled trial: the TENS-PAD study. Trials. 2017 Aug 10;18(1):373. doi: 10.1186/s13063-017-1997-1.

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
Ministry of Health, France

location_facility: Toulouse University Hospital (CHU de Toulouse)

region: Occitanie

nom_etablissement: CHU TOULOUSE

acronyme: TENS-AOMI

titre: Efficacité de l'électrostimulation nerveuse transcutanée (TENS) dans l'amélioration du périmètre de marche chez le patient avec artériopathie oblitérante des membres inférieurs au stade de claudication intermittente.

nom_porteur: LABRUNEE

prenom_porteur: Marc


title: Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants: Randomized Controlled Multicenter Study of Edelvaiss Multiline NEO Device

acronym: MultilineNEO

summary: This study evaluates the potential interest of a new multi-lumen infusion access device (Edelvaiss® Multiline NEO) in the prevention of catheter-related bacteremia when administering injectable drugs in premature infants. This device will be compared to the standard infusion set of each center.

ReferenceCitation: Mahieu LM, De Dooy JJ, Lenaerts AE, Ieven MM, De Muynck AO. Catheter manipulations and the risk of catheter-associated bloodstream infection in neonatal intensive care unit patients. J Hosp Infect. 2001 May;48(1):20-6. doi: 10.1053/jhin.2000.0930.

ReferenceCitation: Erdei C, McAvoy LL, Gupta M, Pereira S, McGowan EC. Is zero central line-associated bloodstream infection rate sustainable? A 5-year perspective. Pediatrics. 2015 Jun;135(6):e1485-93. doi: 10.1542/peds.2014-2523. Epub 2015 May 18.

publisher_dissemination: American Academy of Pediatrics (AAP)

ReferenceCitation: Maiguy-Foinard A, Decaudin B, Tourneux P, Guillois B, Blanc T, Galene-Gromez S, Masse M, Odou P, Denies F, Dervaux B, Duhamel A, Storme L. Effect of multi-lumen perfusion line on catheter-related bacteremia in premature infants: study protocol for a cluster-randomized crossover trial. Trials. 2019 Feb 11;20(1):115. doi: 10.1186/s13063-019-3218-6.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

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

repository_normalized: LillOA (Lille Open Archive)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central

location_facility: Hôpital Jeanne de Flandre - CHRU de Lille


title: Effectiveness of a Joint Crisis Plan (SOS Plan) in Preventing Relapses in Patients Diagnosed With Schizophrenia and Schizoaffective Disorder

acronym: SOS

summary:
The Joint Crisis Plan = SOS Plan is a reference to a particular form of psychiatric advance directive which involves the patient, the healthcare team, their relatives and a third party caregiver as intermediary for the project.

The main objective is to evaluate the effectiveness of the SOS Plan (JCP) in terms of the reduction in hospitalisations within 18 months of its development by comparison to the standard psychiatric care.

Thus, the investigators' proposal is that SOS Plan's are regularly reassessed every 6 months and again where there is an unplanned psychiatric readmission that lasts beyond two weeks.

Single blind multicentre randomised trial with parallel control groups.

Effectiveness study of a psychiatric care strategy.

location_facility:
University Hosiptal, Lille
University Hospital, Brest
University Hospital, Caen
Sainte-Anne Hospital, Paris

acronyme: SOS

titre: Efficacité d'un joint crisis plan dans la prévention des rechutes des patients atteints de schizophrénie et de troubles schizoaffectifs

discipline_principale: psychiatrie / addictologie

nom_porteur: MAITRE

prenom_porteur: Elsa


title: Evaluation of the Efficacy of Serotoninergic Antidepressants in Bulimia Nervosa, According to Brain Serotonin Profile Determined by Positron Emission Tomography With [18F] MPPF - a Multicenter Study

summary:
Bulimia nervosa (BN) is a serious mental illness characterized by massive food crises followed by anxiety and compensatory behaviours (vomiting more often). Recent data show an increasing prevalence and a serious prognosis, due to excess mortality by suicide but also somatic complications.

Two types of treatments are validated : serotoninergic antidepressants (SSRI) and psychotherapy. Many clinical trials confirm the effectiveness of the SSRI. But many studies also emphasize the important proportion of non-responders to SSRI, few of them analyze the reasons for this non-answer.

To better understand the mode of action of SSRI, we should analyse the serotonergic activity in the central nervous system in bulimia. Recently, specific brain 5HT1A serotonin receptor ligands ([18F] MPPF or [11 C] WAY-100635), were used in positron emission tomography (PET) to characterize the serotonergic abnormalities of bulimic patients. The ligand [18F] MPPF has the feature to be sensitive to the level of endogenous serotonin.

A first pilot study using PET with [18F] MPPF realized between the University Hospital of Saint Etienne and Lyon CERMEP showed a diffuse increase of the binding potential of [18F] MPPF in bulimic patients, suggesting a decrease in serotonin activity.

The brain regions affected were angular gyrus, medial frontal cortex, left insula, cingulate gyrus and orbitofrontal gyrus. These areas are involved in major bulimic symptoms (impulse, taste, instinct, anxiety and satiety). However, we noticed an interindividual heterogeneity of cortical binding of [18F] MPPF.

In front of the heterogeneity in terms of efficacity of SSRI and brain serotoninergic activity, it seems necessary to continues investigations, to determine if there is a link between brain serotonin profile and responding to SSRI in bulimia nervosa.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Groupement Hospitalier Est - HCL
Chu Saint-Etienne
CHU de Clermont-Ferrand
CHU Grenoble


title: MultiGFR: Equivalency Study of Different Methods of Measuring Glomerular Filtration Rate

acronym: MultiGFR

summary: The purpose of this study is to validate in comparison to a reference method (inuline) two novel non-radioactive biomarkers for glomerular filtration rate (GFR) measurement in chronic-kidney disease (CKD) patients and in healthy volunteers: Calcium-EDTA and Gd-DOTA.

primary_purpose: Diagnostic

location_facility: CHU Rangueil (service explorations fonctionnelles physiologiques)

location_facility: Hopital Europeen Georges Pompidou (service de Physiologie et des Radioisotopes)

location_facility: Hopital Europeen Georges Pompidou (Service de Nephrologie)

location_facility: Hopital Europeen Georges Pompidou (centre d'investigations cliniques)


title: Treatment of Hyperhidrosis With Oxybutynin: a Randomized Controlled Double Blind Against Placebo

summary: Evaluation of the effectiveness of oxybutynin in hyperhidrosis

lead_sponsor: University Hospital, Brest

sponsor_collaborators:
University Hospital, Brest
Ministry of Health, France

location_facility:
Dermatologist'S Office
Hospital, Brest
CHG Landerneau
CHG de Morlaix


title: Randomized Double-blind Placebo-controlled Trial: Administration of Morphine-Placebo vs. Morphine-Midazolam in Pre-hospital Traumatic Patients With Severe Acute Pain.

acronym: Morphine-Mida

summary:
Administration of midazolam with morphine in patients with severe acute pain is a routine practice in the management of pre- and post-operative patients but has not been evaluated in pre-hospital setting. The investigators aim to evaluate the co-analgesic effect of midazolam in the pre-hospital management of traumatic patients with severe acute pain.

In a multicenter prospective randomized double-blind placebo-controlled trial, the investigators would like to compare the analgesic effect and safety of the intravenous morphine 0.10 mg/kg and midazolam 0.04 mg/kg with the intravenous morphine 0.10 mg/kg and placebo in pre-hospital traumatic adults. Assessment will be done at the baseline using a validated numeric rating scale (NRS).

The primary outcome will be the proportion of patients with a pain score less than or equal to 3 after 20 minutes. The secondary outcomes will be in between-group comparison of: the treatment safety, pain score every 5 minutes during 30 minutes and the total morphine dose required until obtaining a pain score less than or equal to 3.

ReferenceCitation: Auffret Y, Gouillou M, Jacob GR, Robin M, Jenvrin J, Soufflet F, Alavi Z. Does midazolam enhance pain control in prehospital management of traumatic severe pain? Am J Emerg Med. 2014 Jun;32(6):655-9. doi: 10.1016/j.ajem.2014.01.048. Epub 2014 Feb 4.

lead_sponsor: Centre Hospitalier de Cornouaille

sponsor_collaborators:
Centre Hospitalier de Cornouaille
Ministry of Health, France

location_facility: Centre Hpistalier Intercommunal de Cornouaille


title: Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium

summary: At present, all commercially available corneal organ culture media contain foetal calf serum (FCS) and sometimes other compounds extracted from animals. These compounds are necessary for corneal cell survival but are problematic because they theoretically have risk of anthropozoonosis transmission, especially for new variant of CJD and the variability between FCS batches influence graft quality. Our laboratory research allowed in vitro and ex vivo validation of a new medium free compound animal. We proved its superiority over conventional medium containing 2% FCS for endothelial cell survival during the storage time. The goal of this clinical trial is now to assess its superiority in patients.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU Besançon
CHU Saint-Etienne
CHU Grenoble
CHU Clermont-Ferrand