title: A 24-Week, Ph1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, to Assess the Safety Profile of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.

acronym: MSREPAIR

summary: This is a 24-week phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter safety study comparing the tolerance profile of olesoxime (495 mg, od) when administered on top of Interferon beta in patients with stable Relapsing Remitting Multiple Sclerosis. Patients will be randomly allocated to olesoxime (495 mg, od) or placebo in a 1:1 ratio.

lead_sponsor: Hoffmann-La Roche

location_facility: CHU Reims, Maison Blanche Hospital, Neurology Department & University of Reims

location_facility: Timone University Hospital, Neurology Department, UMR CRMBM CNRS 6612


title: A Comparative Double Blind Placebo-Controlled Study of Immunogenicity and Safety of Two Doses 10^5 and 10^7 CFU of SC599 Oral Vaccine, a Live Attenuated Shigella Dysenteriae 1 Vaccine Strain in Healthy Human Adult Volunteers

summary: The purpose of this study is to assess the immune response produced by two doses of SC599 vaccine compared to placebo.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

lead_sponsor: Institut Pasteur

location_country:
United Kingdom
France

location_facility: Dept of Cellular and Molecular Medicine, St George's Hospital Vaccine Institute

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Fetoscopic Endoluminal Tracheal Occlusion (FETO) With Smart-TO Device in Fetuses With Congenital Diaphragmatic Hernia and Moderate to Severe Pulmonary Hypoplasia: Proof of Concept and Safety Evaluation.

acronym: Smart-FETO

summary: The purpose of this study is to make the proof of concept and to evaluate the safety of fetoscopic endoluminal tracheal occlusion (FETO) using Smart-TO device in fetuses with congenital diaphragmatic hernia and moderate to severe pulmonary hypoplasia

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Treatment

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Béclère
Hôpital Bicêtre

intervention_type: Procedure

status_simplified: Ongoing


title: A Phase I Dose-Escalation Study of PHA-793887 Administered as a 1-hour IV Infusion on Days 1, 8 and 15 in a 4-Week Cycle in Patients With Advanced/Metastatic Solid Tumors

summary: The purpose of this open-label, multi center, phase I study, was to determine the safety profile of PHA-793887 administered by intravenous infusion to patients with advanced/metastatic solid tumors. This was a dose-finding study to determine the maximum tolerated dose and the dose of PHA-793887 that can be safely used in phase II investigations.

status: Terminated

enrollment_type: Actual

lead_sponsor: Nerviano Medical Sciences

location_facility:
St. James University Hospital
Institut Gustave-Roussy

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


acronym: GADOXY

summary: The purpose of this study is to measure the tissular oxygen saturation in brain by magnetic resonance imaging on subjects and to correlate the results with near infrared spectroscopy measurements.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Grenoble

intervention_type: Other


title: Controlled, Randomized Clinical Trial of the Circaid® Compression Sleeve Versus Short-stretching Bandage at the Reduction Phase of Upper Limb Lymphatic Edema and Versus Compression Sleeve and Short-stretching Bandages at the Initial Maintenance Phase

summary:
One of the difficulties encountered in the treatment of lymphedema, both in the active reduction phase and in the maintenance phase, is the appliance of the short-length compression bandages which requires good technicality and experience to exert the pressure required to remove liquids from tissue spaces and reduce the volume of the arm or prevent it from increasing again.

The study aims to compare the current protocol of care considered optimal for the reduction of lymphedema and the maintenance of this reduction with the protocol of care which would integrate the device circaid® in substitution to the laying of bands with short extension as it is now in other countries.

ReferenceType: background

ReferenceCitation: Paskett ED, Dean JA, Oliveri JM, Harrop JP. Cancer-related lymphedema risk factors, diagnosis, treatment, and impact: a review. J Clin Oncol. 2012 Oct 20;30(30):3726-33. doi: 10.1200/JCO.2012.41.8574. Epub 2012 Sep 24. Review.

ReferenceCitation: Leone N, Voirin N, Roche L, Binder-Foucard F, Woronoff AS, Delafosse P, Remontet L, Bossard N, Uhry Z. Projection de l'incidence et de la mortalité par cancer en France métropolitaine en 2015. Rapport technique. Saint-Maurice (Fra): Institut de veille sanitaire, 2015. 62 p

ReferenceCitation: Grosclaude P, Remontet L, Belot A, Danzon A, Rasamimanana C, Bossard N. Survie des personnes atteintes de cancer en France, 1989-2007 - Etude à partir des registres des cancers du réseau Francim. Saint-Maurice: Institut de veille sanitaire; 2013. 412 p

ReferenceCitation: Hayes SC, Janda M, Cornish B, Battistutta D, Newman B. Lymphedema after breast cancer: incidence, risk factors, and effect on upper body function. J Clin Oncol. 2008 Jul 20;26(21):3536-42. doi: 10.1200/JCO.2007.14.4899.

ReferenceCitation: Campbell KL, Pusic AL, Zucker DS, McNeely ML, Binkley JM, Cheville AL, Harwood KJ. A prospective model of care for breast cancer rehabilitation: function. Cancer. 2012 Apr 15;118(8 Suppl):2300-11. doi: 10.1002/cncr.27464. Review.

ReferenceCitation: Velanovich V, Szymanski W. Quality of life of breast cancer patients with lymphedema. Am J Surg. 1999 Mar;177(3):184-7; discussion 188.

ReferenceCitation: Shih YC, Xu Y, Cormier JN, Giordano S, Ridner SH, Buchholz TA, Perkins GH, Elting LS. Incidence, treatment costs, and complications of lymphedema after breast cancer among women of working age: a 2-year follow-up study. J Clin Oncol. 2009 Apr 20;27(12):2007-14. doi: 10.1200/JCO.2008.18.3517. Epub 2009 Mar 16.

ReferenceCitation: Framework L. Best practice for the management of lymphoedema: an international consensus. London: MEP Ltd; 2006

ReferenceCitation: Chang CJ, Cormier JN. Lymphedema interventions: exercise, surgery, and compression devices. Semin Oncol Nurs. 2013 Feb;29(1):28-40. doi: 10.1016/j.soncn.2012.11.005. Review.

ReferenceCitation: Quéré I, Presles E, Coupé M, Vignes S, Vaillant L, Eveno D, Laporte S, Leizorovicz A; POLIT Study investigators. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014 Jul;39(4):256-63. doi: 10.1016/j.jmv.2014.05.004. Epub 2014 Jun 12.

ReferenceCitation: Lymphoedema Framework International consensus. Best Practice for the management of Lymphoedema London: MEP Ltd, 2006 and 2nd Edition 2012

ReferenceCitation: Vignes S, Porcher R, Arrault M, Dupuy A. Factors influencing breast cancer-related lymphedema volume after intensive decongestive physiotherapy. Support Care Cancer. 2011 Jul;19(7):935-40. doi: 10.1007/s00520-010-0906-x. Epub 2010 May 22.

lead_sponsor: CEN Biotech

location_facility:
Chu Saint Eloi
Hopital Cognacq Jay
Polyclinique Bordeaux Nord Aquitaine
Ghr Mulhouse Sud Alsace

intervention_type: Device


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. Review.

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

ReferenceCitation: Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, Christensen E, Pagliaro L, Colombo M, Rodés 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.

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.

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. Review.

ReferenceCitation: Jonas S, Bechstein WO, Steinmüller 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.

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.

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. 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.

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.

lead_sponsor: Angiodynamics, Inc.

location_country: Italy Germany France Spain

location_facility: Istituto Nazionale Tumori - Fondazione Pascale

location_facility: Universitatsklinikum Magdeburg AoR, Klinik fur Radiologie und Nuklearmedizin

location_facility: L'institut de cancerologie Gustave Roussy

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


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.

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

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


type: EudraCT Number

title: Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers - Investigator and Subject Satisfaction

acronym: FRESH

summary: The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction linked to the global management of facial rejuvenation with a new range of hyaluronic acid dermal fillers.

lead_sponsor: Galderma R&D

location_country: Germany France


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.

lead_sponsor: Stallergenes Greer

location_country:
United States
France

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

status: Active, not recruiting

lead_sponsor: Biosensors Europe SA

location_country: France Switzerland

location_facility:
Triemli Stadtspital
at Hôpital Privé Claude Galien ICPS


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:
Italy
United States
France
Spain
Germany

location_facility: University of Virginia Transplant Center

location_facility: University of California - Davis Clinical Trials

location_facility: Carolinas HealthCare System Center for Liver Disease

location_facility: Northwestern University Division of Gastroenterology and Hepatology

location_facility: University of Arkansas for Medical Sciences

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Southern Therapy and Advanced Research LLC

location_facility: University of Iowa Hospitals and Clinics

location_facility: Rutgers-Robert Wood Johnson Medical School

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Providence Health & Services Cancer Clinical Trials

location_facility: University of California - San Francisco

location_facility: University of Florida Hepatology Research at CTRB

location_facility: Northwell Health - Center for Liver Disease

location_facility: Clinical Research Institute@ Methodist Dallas Medical Center

location_facility: University of Texas Southwestern Medical Center

location_facility: Vanderbilt University Medical Center - GI Research Office

location_facility: University of Florida - Health Gastroenerology


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.

status: Unknown status

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Ngo C, Samuels S, Bagrintseva K, Slocker A, Hupé 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.

family: Ngo

full_name: Charlotte Ngo

given: Charlotte

sequence: first

family: Samuels

full_name: Sanne Samuels

given: Sanne

sequence: additional

family: Bagrintseva

full_name: Ksenia Bagrintseva

given: Ksenia

family: Slocker

full_name: Andrea Slocker

given: Andrea

family: Hupé

full_name: Philippe Hupé

given: Philippe

family: Kenter

full_name: Gemma Kenter

given: Gemma

family: Popovic

full_name: Marina Popovic

given: Marina

family: Samet

full_name: Nina Samet

given: Nina

family: Tresca

full_name: Patricia Tresca

given: Patricia

family: von der Leyen

full_name: Heiko von der Leyen

given: Heiko

family: Deutsch

full_name: Eric Deutsch

given: Eric

family: Rouzier

full_name: Roman Rouzier

given: Roman

family: Belin

full_name: Lisa Belin

given: Lisa

family: Kamal

full_name: Maud Kamal

given: Maud

family: Scholl

full_name: Suzy Scholl

given: Suzy

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMC Cancer

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: From prospective biobanking to precision medicine: BIO-RAIDs – an EU study protocol in cervical cancer

lead_sponsor: Institut Curie

location_country: Serbia Netherlands France Romania Germany

location_facility: Spitalul Clinic Municipal "Gavril Curteanu"

location_facility: Institut de Cancérologie de Lorraine- ICL NANCY

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

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

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

location_facility: Institut de Cancérologie de Lorraine - ICL

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

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

location_facility: Centre Hospitalier Intercommunal de Créteil - CHI Créteil

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


lead_sponsor: Orfagen

location_facility: Hôpital Bretonneau Service de neuroradiologie

source: euctr

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.

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.


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

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. Review.

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. Review.

ReferenceCitation: ALT J, NONCLERCQ E. [Treatment of psoriasis by ultraviolet and photosensitizers]. Bull Soc Fr Dermatol Syphiligr. 1953 Jul-Oct;60(4):343-5. Undetermined Language.

ReferenceCitation: Grupper C, Bourgeois-Spinasse J, Eisenmann D. [Treatment of psoriasis in 1970]. Cah Med. 1970 Sep;11:Suppl:15-20. French.

ReferenceCitation: Oddoze L, Témime 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. 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.

ReferenceCitation: Young E. Ultraviolet therapy of psoriasis: a critical study. Br J Dermatol. 1972 Oct;87(4):379-82.

ReferenceCitation: van de Kerkhof PC. Therapeutic strategies: rotational therapy and combinations. Clin Exp Dermatol. 2001 Jun;26(4):356-61. Review.

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.

ReferenceCitation: Lebwohl M. Combining the new biologic agents with our current psoriasis armamentarium. J Am Acad Dermatol. 2003 Aug;49(2 Suppl):S118-24. Review.

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, Lançon C, Bonerandi JJ. Development and validation of a quality of life measurement for chronic skin disorders in french: VQ-Dermato. The RéseaudEpidémiolo gie en Dermatologie. Dermatology. 1999;199(3):213-22.

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, Hönigsmann 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. Review.

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.

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.

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

lead_sponsor: Association Francaise pour la Recherche Thermale

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


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: Í Dali C, Sevin C, Krägeloh-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.

family: í Dali

full_name: Christine í Dali

given: Christine

family: Sevin

full_name: Caroline Sevin

given: Caroline

family: Krägeloh-Mann

full_name: Ingeborg Krägeloh-Mann

given: Ingeborg

family: Giugliani

full_name: Roberto Giugliani

given: Roberto

family: Sakai

full_name: Norio Sakai

given: Norio

family: Wu

full_name: James Wu

given: James

family: Wasilewski

full_name: Margaret Wasilewski

given: Margaret

journal_name: Molecular Genetics and Metabolism

oa_host_type: publisher

evidence: open (via crossref license)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: 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: France Japan Australia Denmark Germany

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


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: France Netherlands

location_facility:
Hospital Georges Pompidou
Atrium Medisch Centrum


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.

family: Zallocchi

full_name: Marisa Zallocchi

given: Marisa

family: Binley

full_name: Katie Binley

given: Katie

family: Lad

full_name: Yatish Lad

given: Yatish

family: Ellis

full_name: Scott Ellis

given: Scott

family: Widdowson

full_name: Peter Widdowson

given: Peter

family: Iqball

full_name: Sharifah Iqball

given: Sharifah

family: Scripps

full_name: Vicky Scripps

given: Vicky

family: Kelleher

full_name: Michelle Kelleher

given: Michelle

family: Loader

full_name: Julie Loader

given: Julie

family: Miskin

full_name: James Miskin

family: Peng

full_name: You-Wei Peng

given: You-Wei

family: Wang

full_name: Wei-Min Wang

given: Wei-Min

family: Cheung

full_name: Linda Cheung

given: Linda

family: Delimont

full_name: Duane Delimont

given: Duane

family: Mitrophanous

full_name: Kyriacos A. Mitrophanous

given: Kyriacos A.

family: Cosgrove

full_name: Dominic Cosgrove

given: Dominic

currency_apc_doaj: USD

journal_name: PLoS ONE

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: EIAV-Based Retinal Gene Therapy in the shaker1 Mouse Model for Usher Syndrome Type 1B: Development of UshStat

ipd_sharing_description: Qualified researchers may request access to participant 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. Participant 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://www.clinicalstudydatarequest.com/

location_facility:
Investigational Site Number 840001
Investigational Site Number 250001

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

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.


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


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: Nestlé

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


location_country: Brazil France Czechia Japan Australia Denmark Germany

location_facility: Hopital Gui de Chauliac - CHRU de Montpellier

location_facility: Center for Pediatric Clinical Studies (CPCS)

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

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.


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.

family: Goldwirt

full_name: Lauriane Goldwirt

given: Lauriane

family: Braun

full_name: Joséphine Braun

given: Joséphine

family: de Castro

full_name: Nathalie de Castro

given: Nathalie

family: Charreau

full_name: Isabelle Charreau

given: Isabelle

family: Barrail-Tran

full_name: Aurélie Barrail-Tran

given: Aurélie

family: Delaugerre

full_name: Constance Delaugerre

given: Constance

family: Raffi

full_name: François Raffi

given: François

family: Lascoux-Combe

full_name: Caroline Lascoux-Combe

given: Caroline

family: Aboulker

full_name: Jean-Pierre Aboulker

given: Jean-Pierre

family: Taburet

full_name: Anne-Marie Taburet

given: Anne-Marie

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

journal_name: Antimicrobial Agents and Chemotherapy

oa_colors: green hybrid

evidence: open (via free pdf)

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

title: Switch from Enfuvirtide to Raltegravir Lowers Plasma Concentrations of Darunavir and Tipranavir: a Pharmacokinetic Substudy of the EASIER-ANRS 138 Trial

ReferenceCitation: Barau C, Delaugerre C, Braun J, de Castro N, Furlan V, Charreau I, Gérard 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.

name: Department of Clinical Pharmacy, Bicêtre Hospital, Assistance Publique Hôpitaux de Paris, Le Kremlin Bicêtre, France

family: Barau

full_name: Caroline Barau

name: Virology, Saint-Louis Hospital, Assistance Publique Hôpitaux de Paris, Paris, France

full_name: Joséphine Braun

given: Joséphine

family: Furlan

full_name: Valérie Furlan

given: Valérie

name: Department of Internal Medicine, Saint-Louis Hospital, Assistance Publique Hôpitaux de Paris, Paris, France

title: High Concentration of Raltegravir in Semen of HIV-Infected Men: Results from a Substudy of the EASIER-ANRS 138 Trial

ReferenceCitation: Delaugerre C, Charreau I, Braun J, Néré 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.

publisher: Ovid Technologies (Wolters Kluwer Health)

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.

title: 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)

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.

name: Department of Infectious Diseases, Assistance Publique Hôpitaux de Paris, Saint-Louis Hospital, Paris, France

name: University of Paris-Diderot Paris 7, Paris, France

name: Laboratory of Virology, Saint-Louis Hospital, Paris, France

name: Department of Infectious Diseases, Gui de Chauliac University Hospital, Montpellier, France

name: Department of Internal Medicine, E. Herriot Hospital, Lyon, France

name: Department of Infectious Diseases, Côte de Nacre Hospital, Caen, France

name: Department of Infectious Diseases, Raymond Poincaré Hospital, Garches, France

name: Department of Infectious Diseases, Brabois Hospital, Nancy, France

name: Pharmacy, Saint-Louis Hospital, Paris, France

name: on behalf of the EASIER ANRS 138 Study Group

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.

name: Virology Department; Saint-Louis Hospital-APHP, Inserm U941-Paris 7 Diderot University; Paris; France

name: Infectious Diseases Department; Saint-Louis Hospital-APHP, Paris 7 Diderot University; Paris; France

name: Infectious Diseases Department; Brabois Hospital, Vandoeuvre-les-Nancy; Toulouse; France

name: Infectious and Tropical Diseases Department; Purpan Hospital; Toulouse; France

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

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

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.

title: Switch from Enfuvirtide to Raltegravir in Virologically Suppressed Multidrug‐Resistant HIV‐1–Infected Patients: A Randomized Open‐Label Trial

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

location_facility: Service des maladies infectieuses et tropicales Hopital Saint Louis


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

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU Limoges Service de neurologie et CMRR

location_facility: CHU de Nantes Clinique Neurologique Hôpital GR Laennec

location_facility: Hospice Civil de Lyon Hôpital des Charpennes

location_facility: CHRU Cavale Blanche Service de Gériatrie

location_facility: APHP Groupe Hospitalier Saint Louis Lariboisière Fernand Widal CMRR

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

location_facility: CHU de Clermont Ferrand Centre Mémoire Ressources Recherche

location_facility: CHU Montpellier Hôpital Gui de Chauliac CMRR

location_facility: CHU d'Amiens Centre Mémoire Ressources Recherche

location_facility: CHRU de Bretonneau Unité de gérontopsychiatrie

location_facility: Service de Neuropsychologie Hôpital Neurologique Pierre Wertheimer

location_facility: CHU d'Angers Centre Mémoire Ressources Recherche

location_facility: CHU de Bastia Centre Mémoire Ressources Recherche

location_facility: CHU Côte de Nacre Service de neurologie et CMRR

location_facility: Hôpital Universitaire de la Pitié Salpêtrière Pavillon François Lhermitte

location_facility: CHU Reims Hôpital Maison Blanche Court Séjour Gériatrique

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

location_facility: CHU de Besançon Centre Mémoire Ressources Recherche

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

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

location_facility: CHU de Rouen Hôpital Charles Nicolle Service Neurologie

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


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.

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.

lead_sponsor: University Hospital, Toulouse

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

location_facility: Service de Chirurgie Cardio Vasculaire - Clinique Pasteur

location_facility: Service de Chirurgie Cardio-vasculaire - CHU Dupuytren

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

location_facility: Service de Chirurgie Cardio Vasculaire - CHU RANGUEIL


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 nimes - Hôpital Universitaire Caremeau


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

time_perspective: Retrospective

lead_sponsor: Abbott

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


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: Netherlands France Bulgaria Romania Belgium Spain Germany

location_facility: Patrick GIRAUD, Bat C 132 av Gabriel Péri

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

location_facility: Centre Hospitalier Général, 22, boulevard Général Sibille

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

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

location_facility: Clinique Sainte-Elisabet, Place Louise Godin 1

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

location_facility: Centre Hospitalier Général, 516 avenue de Paris

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

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

location_facility: Centre Hospitalier Général, 10 rue de la Charité

location_facility: Jean Claude GICHTENAERE, 8 quai du Général Leclerc

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

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

location_facility: National Cardiology Hospital EAD, 65 Konjovitza Str.

location_facility: Klinikum Coburg , Ketschendorfer Str. 33

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

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

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

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

location_facility: "Academisch Ziekenhuis Maastricht, P. Debyelaan 25

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

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

location_facility: Hospital Universitario de Getafe, Carretera de toledo

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

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

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

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

location_facility: Centre Hospitalier Regional, 1 rue du Friscaty

location_facility: Centre médical, Promenade du petit Languedoc

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

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

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

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

location_facility: Regionaal Ziekenhuis Heilig Hart, Naamsestraat 105

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

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

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


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. Review.

ReferenceCitation: Sesay M, Vignes JR, Stöckle 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. 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, Clément 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. Review.

ReferenceCitation: Galley HF. Editorial II: Solid as a ROC. Br J Anaesth. 2004 Nov;93(5):623-6.

lead_sponsor: Association de Developpement de la Neuroanesthesie Reanimation


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, Ekström 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.

name: Hôpital Bichat – Service de Pneumologie A, Paris, France

family: Aubier

full_name: Michel Aubier

given: Michel

name: Centre of Academic Primary Care, University of Aberdeen, Aberdeen, Scotland, UK

family: Haughney

full_name: John Haughney

given: John

family: Selroos

full_name: Olof Selroos

given: Olof

name: Maastricht University/CAPHRI, Maastricht, The Netherlands

family: van Schayck

full_name: Onno C. P. van Schayck

given: Onno C. P.

name: Medical Department, AstraZeneca, Södertälje, Sweden

family: Ekström

full_name: Tommy Ekström

given: Tommy

name: Medical Department, AstraZeneca, Rueil Malmaison, France

family: Ostinelli

full_name: Juliette Ostinelli

given: Juliette

name: Pulmonary Department, Mainz University Hospital, Mainz, Germany

family: Buhl

full_name: Roland Buhl

given: Roland

journal_name: Therapeutic Advances in Respiratory Disease

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: Is the patient’s baseline inhaled steroid dose a factor for choosing the budesonide/formoterol maintenance and reliever therapy regimen?

ReferenceCitation: Haughney J, Aubier M, Jørgensen 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.

full_name: J. Haughney

given: J.

full_name: M. Aubier

given: M.

family: Jørgensen

full_name: L. Jørgensen

given: L.

full_name: J. Ostinelli

full_name: O. Selroos

given: O.

full_name: C.P. van Schayck

full_name: R. Buhl

given: R.

journal_name: Respiratory Medicine

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Aubier M, Buhl R, Ekström 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.

family: Ekstrom

full_name: T. Ekstrom

given: T.

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


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, Brière 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.

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: Observational Cohort Study Evaluating the Use and Efficacy of Pomalidomide in Patients With Multiple Myeloma in Routine Clinical Practice

acronym: MIROIR

summary:
This study, a national, multicenter, observational, ambispective, non-interventional study, will be conducted in French hospitals prescribing pomalidomide and already participating in the ongoing Imnovid registry.

This study will add to the registry. Indeed, pomalidomide-prescribing physicians and pharmacists dispensing pomalidomide have to enter into the Imnovid registry all patients who have been prescribed this drug since the date on which it was marketed regardless of the initiation date of pomalidomide or the indication for which it was prescribed.

ReferenceCitation: Waldschmidt JM, Simon A, Wider D, Müller SJ, Follo M, Ihorst G, Decker S, Lorenz J, Chatterjee M, Azab AK, Duyster J, Wäsch R, Engelhardt M. CXCL12 and CXCR7 are relevant targets to reverse cell adhesion-mediated drug resistance in multiple myeloma. Br J Haematol. 2017 Oct;179(1):36-49. doi: 10.1111/bjh.14807. Epub 2017 Jul 2.

ReferenceCitation: Dinner S, Dunn TJ, Price E, Coutré SE, Gotlib J, Berube C, Kaufman GP, Medeiros BC, Liedtke M. A phase I, open-label, dose-escalation study of amrubicin in combination with lenalidomide and weekly dexamethasone in previously treated adults with relapsed or refractory multiple myeloma. Int J Hematol. 2018 Sep;108(3):267-273. doi: 10.1007/s12185-018-2468-5. Epub 2018 May 25.

ReferenceCitation: Garderet L, Kuhnowski F, Berge B, Roussel M, Escoffre-Barbe M, Lafon I, Facon T, Leleu X, Karlin L, Perrot A, Moreau P, Marit G, Stoppa AM, Royer B, Chaleteix C, Tiab M, Araujo C, Lenain P, Macro M, Voog E, Benboubker L, Allangba O, Jourdan E, Orsini-Piocelle F, Brechignac S, Eveillard JR, Belhadj K, Wetterwald M, Pegourie B, Jaccard A, Eisenmann JC, Glaisner S, Mohty M, Hulin C, Loiseau HA, Mathiot C, Attal M. Pomalidomide, cyclophosphamide, and dexamethasone for relapsed multiple myeloma. Blood. 2018 Dec 13;132(24):2555-2563. doi: 10.1182/blood-2018-07-863829. Epub 2018 Oct 3.

name: Proliferation and Differentiation of Stem Cells, INSERM, Unité Mixte de Recherche (UMR)_S 938, Paris, France;

name: Département d'Hématologie et de Thérapie Cellulaire, Assistance Publique des Hôpitaux de Paris, Hôpital Saint Antoine, Paris, France;

family: Garderet

full_name: Laurent Garderet

given: Laurent

family: Kuhnowski

full_name: Frederique Kuhnowski

given: Frederique

family: Berge

full_name: Benoit Berge

given: Benoit

name: Centre Hospitalier Universitaire, Institut Universitaire du Cancer de Toulouse–Oncopole, Toulouse, France;

family: Roussel

full_name: Murielle Roussel

given: Murielle

name: Centre Hospitalier Universitaire, Rennes, France;

family: Escoffre-Barbe

full_name: Martine Escoffre-Barbe

given: Martine

name: Centre Hospitalier Universitaire, Dijon, France;

family: Lafon

full_name: Ingrid Lafon

given: Ingrid

name: Maladies du Sang, Hôpital Claude Huriez, Centre Hospitalier Régional Universitaire Lille, Lille, France;

family: Facon

full_name: Thierry Facon

given: Thierry

family: Leleu

full_name: Xavier Leleu

given: Xavier

name: Hospices Civils de Lyon, Pierre Benite Cedex, France;

family: Karlin

full_name: Lionel Karlin

given: Lionel

name: Centre Hospitalier Universitaire, Vandoeuvre Les Nancy, France;

family: Perrot

full_name: Aurore Perrot

given: Aurore

name: Centre Hospitalier Universitaire Hôtel Dieu, Nantes, France;

family: Moreau

full_name: Philippe Moreau

given: Philippe

name: Centre Hospitalier Universitaire, Bordeaux, France;

family: Marit

full_name: Gerald Marit

given: Gerald

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

family: Stoppa

full_name: Anne-Marie Stoppa

given: Anne-Marie

name: Centre Hospitalier Universitaire, Amiens, France;

family: Royer

full_name: Bruno Royer

given: Bruno

name: Centre Hospitalier Universitaire, Clermont Ferrand, France;

family: Chaleteix

full_name: Carine Chaleteix

given: Carine

name: Hopital de La Roche sur Yon, La Roche sur Yon, France;

family: Tiab

full_name: Mourad Tiab

given: Mourad

name: Centre Hospitalier de la Côte Basque, Bayonne, France;

family: Araujo

full_name: Carla Araujo

given: Carla

family: Lenain

full_name: Pascal Lenain

given: Pascal

name: Centre Hospitalier Universitaire, Caen, France;

family: Macro

full_name: Margaret Macro

given: Margaret

name: Centre Hospitalier de Le Mans, Le Mans, France;

family: Voog

full_name: Eric Voog

given: Eric

name: Centre Hospitalier Universitaire, Hôpital Bretonneau, Tours, France;

family: Benboubker

full_name: Lofti Benboubker

given: Lofti

name: Centre Hospitalier de Saint Brieuc, Saint Brieuc, France;

family: Allangba

full_name: Olivier Allangba

given: Olivier

name: Centre Hospitalier Universitaire, Nîmes, France;

family: Jourdan

full_name: Eric Jourdan

name: Centre Hospitalier de la région d’Annecy, Pringy, France;

name: Centre Hospitalier Universitaire Henri Mondor, Créteil, France;

name: Centre Hospitalier Général, Dunkerque, France;

name: Centre Hospitalier Régional et Universitaire, Grenoble, France;

name: Centre Hospitalier Universitaire, Limoges, France;

name: Hôpital René Huguenin, Saint Cloud, France; and

ReferenceCitation: Mark TM, Forsberg PA, Rossi AC, Pearse RN, Pekle KA, Perry A, Boyer A, Tegnestam L, Jayabalan D, Coleman M, Niesvizky R. Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma. Blood Adv. 2019 Feb 26;3(4):603-611. doi: 10.1182/bloodadvances.2018028027.

ReferenceCitation: Ailawadhi S, DerSarkissian M, Duh MS, Lafeuille MH, Posner G, Ralston S, Zagadailov E, Ba-Mancini A, Rifkin R. Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma. Clin Ther. 2019 Mar;41(3):477-493.e7. doi: 10.1016/j.clinthera.2019.01.009. Epub 2019 Feb 14.

ReferenceCitation: Li Y, Wang X, Liu L, Zhang C, Gomez D, Reyes J, Palmisano M, Zhou S. An Open-Label, Phase 1 Study to Assess the Effects of Hepatic Impairment on Pomalidomide Pharmacokinetics. Clin Pharmacol Drug Dev. 2019 Apr;8(3):346-354. doi: 10.1002/cpdd.470. Epub 2018 May 10.

location_facility: Centre Hospitalier Intercommunal Robert Ballanger

location_facility: Hopital Nord Franche-Comte - Site de Belfort


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. pii: jc-00119-15. [Epub ahead of print]

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.

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. 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.

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.

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.

ReferenceCitation: Beaulieu MD, Leclère 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. Review.

ipd_sharing_description: All data will be shared with research team.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

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


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

lead_sponsor: University Hospital, Lille

location_country: Belgium France

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

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

location_facility: Hôpital Robert Debré, Assistance Publique Hôpitaux de Paris

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

location_facility: Hôpital Trousseau, Assistance Publique Hôpitaux de Paris


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.

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


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

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.

family: Hameau

full_name: Sophie Hameau

given: Sophie

family: Bensmail

full_name: Djamel Bensmail

given: Djamel

family: Roche

full_name: Nicolas Roche

given: Nicolas

family: Zory

full_name: Raphaël Zory

given: Raphaël

journal_name: Archives of Physical Medicine and Rehabilitation


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: 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.

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


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

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


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, Sénard JM, Grémeaux V, Riédel M, Garrigues D, Guiraud T, Labrunée 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.

family: Besnier

full_name: Florent Besnier

given: Florent

family: Sénard

full_name: Jean-Michel Sénard

given: Jean-Michel

family: Grémeaux

full_name: Vincent Grémeaux

given: Vincent

family: Riédel

full_name: Mélanie Riédel

given: Mélanie

family: Garrigues

full_name: Damien Garrigues

given: Damien

family: Guiraud

full_name: Thibaut Guiraud

given: Thibaut

family: Labrunée

full_name: Marc Labrunée

given: Marc

journal_name: Trials

location_facility: Toulouse University Hospital (CHU de Toulouse)


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.

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.

family: Erdei

full_name: C. Erdei

given: C.

family: McAvoy

full_name: L. L. McAvoy

given: L. L.

family: Gupta

full_name: M. Gupta

given: M.

family: Pereira

full_name: S. Pereira

given: S.

family: McGowan

full_name: E. C. McGowan

given: E. C.

journal_name: PEDIATRICS

publisher: American Academy of Pediatrics (AAP)

publisher_dissemination: American Academy of Pediatrics (AAP)

publisher_group: American Academy of Pediatrics (AAP)

publisher_normalized: American Academy of Pediatrics (AAP)

title: Is Zero Central Line-Associated Bloodstream Infection Rate Sustainable? A 5-Year Perspective

ReferenceCitation: Maiguy-Foinard A, Décaudin B, Tourneux P, Guillois B, Blanc T, Galène-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.

apc_source: openAPC

family: Maiguy-Foinard

full_name: Aurélie Maiguy-Foinard

given: Aurélie

family: Décaudin

full_name: Bertrand Décaudin

given: Bertrand

family: Tourneux

full_name: Pierre Tourneux

given: Pierre

family: Guillois

full_name: Bernard Guillois

given: Bernard

family: Blanc

full_name: Thierry Blanc

given: Thierry

family: Galène-Gromez

full_name: Sophie Galène-Gromez

family: Masse

full_name: Morgane Masse

given: Morgane

family: Odou

full_name: Pascal Odou

family: Denies

full_name: Fannette Denies

given: Fannette

family: Dervaux

full_name: Benoît Dervaux

given: Benoît

family: Duhamel

full_name: Alain Duhamel

given: Alain

family: Storme

full_name: Laurent Storme

given: Laurent

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

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

repositories:
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, Caen
Sainte-Anne Hospital, Paris
University Hospital, Brest


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:
Chu Saint-Etienne
CHU de Clermont-Ferrand
Groupement Hospitalier Est - HCL
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: Hopital Europeen Georges Pompidou (centre d'investigations cliniques)

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

location_facility: CHU Rangueil (service explorations fonctionnelles physiologiques)

location_facility: Hopital Europeen Georges Pompidou (Service de Nephrologie)


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

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


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.

family: Auffret

full_name: Yannick Auffret

given: Yannick

family: Gouillou

full_name: Maelenn Gouillou

given: Maelenn

family: Jacob

full_name: Gwenael Rolland Jacob

given: Gwenael Rolland

family: Robin

full_name: Morgane Robin

family: Jenvrin

full_name: Joël Jenvrin

given: Joël

family: Soufflet

full_name: Florence Soufflet

given: Florence

family: Alavi

full_name: Zarrin Alavi

given: Zarrin

journal_name: The American Journal of Emergency Medicine

lead_sponsor: Centre Hospitalier de Cornouaille

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.

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


title: Multicenter Randomized Trial of Structured Educational Intervention at the Community Level in Insufficiently Controlled Patients With Type 2 Diabetes in Reunion Island

acronym: ERMIES

summary: Type 2 diabetes has a growing impact on populations and public health worldwide. Clinical trials have clearly demonstrated that a better control of blood glucose level and of other risk factors is efficient in preventing or retarding the complications of the disease. On Reunion island, Type 2 diabetes is present in 18% of population aged 30 or older with a high level of socio-economic deprivation. The hypothesis of the ERMIES study is that a structured group self-management education maintained at the community level for 2 years in patients with insufficiently controlled type 2 diabetes has better metabolic results (as attested by improvement in HbA1c level) at 2 yrs, compared to an initial short term (< 3 months) self-management program, based on the same theoretical basis and framework (learning nests empowerment). A total of 240 adults living in Reunion Island, with type 2 diabetes mellitus with HbA1c ≥ 7.5% on a stable treatment for at least 3 months will be randomly allocated to 2 intervention arms: either a short term (< 3 months) program (1 to 7 thematic 2-hr long sessions depending on individual assessment), or a long term program including the same initial program as 1st arm, but with group self management education sessions, maintained for 2 years (4-monthly assessment, empowerment, and contextual action planning; facultative additional specific thematic sessions being delivered if needed). Medical visits will be held quarterly for the recording of outcome measures (HbA1c, blood pressure, anthropometrics, tobacco consumption, diabetes complications) and yearly for blood glucose, lipids, micro-albuminuria or proteinuria, creatinine clearance, diet and exercise (questionnaires), treatment recording, quality of life, self-efficacy, anxiety and depression scales, and social support.

ReferenceCitation: Debussche X, Collin F, Fianu A, Balcou-Debussche M, Fouet-Rosiers I, Koleck M, Favier F. Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island. Cardiovasc Diabetol. 2012 Aug 2;11:91. doi: 10.1186/1475-2840-11-91.

family: Debussche

full_name: Xavier Debussche

given: Xavier

family: Collin

full_name: Fidéline Collin

given: Fidéline

family: Fianu

full_name: Adrian Fianu

given: Adrian

family: Balcou-Debussche

full_name: Maryvette Balcou-Debussche

given: Maryvette

family: Fouet-Rosiers

full_name: Isabelle Fouet-Rosiers

given: Isabelle

family: Koleck

full_name: Michèle Koleck

given: Michèle

family: Favier

full_name: François Favier

given: François

journal_name: Cardiovascular Diabetology

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

repository_normalized: HAL

repositories:
HAL
PubMed Central

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility: Department of endocrinology, University Hospital Reunion Island - Felix Guyon Site

location_facility: Diabetolgy - UNiversity Hospital Sud Réunion

intervention_type: Behavioral


title: Characterization of Clinical, Biological, Morphological and Pharmacological Factors Influencing Occurrence of Dementia or Cognitive Disorders After Stroke

acronym: strokdem

summary: If the risk of dementia occurrence after stroke is well known, few data exist about the factors influencing positively or negatively the developement of cognitive disorders or dementia. The aim of the study is so to determine prospectively the clinical, biological, lesional and pharmacological factors associated with post-stroke dementia by the long-term follow-up of a stroke patient cohort.

ReferenceCitation: Ponchel A, Labreuche J, Bombois S, Delmaire C, Bordet R, Hénon H. Influence of Medication on Fatigue Six Months after Stroke. Stroke Res Treat. 2016;2016:2410921. doi: 10.1155/2016/2410921. Epub 2016 Jun 19.

name: Degenerative & Vascular Cognitive Disorders, Univ. Lille, INSERM U1171, 59000 Lille, France

name: Department of Medical Pharmacology, Univ. Lille, 59000 Lille, France

name: Department of Neurology, Lille University Hospital, 59000 Lille, France

family: Ponchel

full_name: Amélie Ponchel

given: Amélie

name: Department of Statistics, EA 2694, Univ. Lille, 59000 Lille, France

family: Labreuche

full_name: Julien Labreuche

given: Julien

family: Bombois

full_name: Stéphanie Bombois

given: Stéphanie

name: Department of Neuroradiology, Lille University Hospital, 59000 Lille, France

family: Delmaire

full_name: Christine Delmaire

given: Christine

family: Bordet

full_name: Régis Bordet

given: Régis

family: Hénon

full_name: Hilde Hénon

given: Hilde

journal_name: Stroke Research and Treatment

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

repository_normalized: LillOA (Lille Open Archive)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

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

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

publisher: Hindawi Limited

publisher_dissemination: Hindawi

publisher_group: Hindawi

publisher_normalized: Hindawi

location_facility:
Amiens University Hospital
Lille University Hospital
Rouen University Hospital
Caen University Hospital


title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the ROCC Knee Prosthesis

summary: This observational study intends to collect efficacy and safety data on ROCC Knee system.

lead_sponsor: Zimmer Biomet

location_country: Austria France Spain

location_facility:
Hospital Torrecardenas
Clinique des Fontaines
A. ö Landeskrankenhaus Gmunden


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.

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.

lead_sponsor: Poitiers University Hospital

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