title: Evaluation of the Information of the Patient Before a Scheduled Coronarography

acronym: INFOCORO

summary: French study, multicentrique with the cooperation of several hospital centers . 700 patients (200 in the stage 1 and 500 in the stage 2). Every patient will complete questionnaires in a anonymous way.

ReferenceCitation: Lattuca B, Barber-Chamoux N, Alos B, Sfaxi A, Mulliez A, Miton N, Levasseur T, Servoz C, Derimay F, Hachet O, Motreff P, Metz D, Lairez O, Mewton N, Belle L, Akodad M, Mathivet T, Ecarnot F, Pollet J, Danchin N, Steg PG, Juillière Y, Bouleti C; INFOCORO investigators. Impact of video on the understanding and satisfaction of patients receiving informed consent before elective inpatient coronary angiography: A randomized trial. Am Heart J. 2018 Jun;200:67-74. doi: 10.1016/j.ahj.2018.03.006. Epub 2018 Mar 12.

family: Lattuca

full_name: Benoit Lattuca

given: Benoit

family: Barber-Chamoux

full_name: Nicolas Barber-Chamoux

given: Nicolas

family: Alos

full_name: Benjamin Alos

given: Benjamin

family: Sfaxi

full_name: Anis Sfaxi

given: Anis

family: Mulliez

full_name: Aurélien Mulliez

given: Aurélien

family: Miton

full_name: Noelie Miton

given: Noelie

family: Levasseur

full_name: Thomas Levasseur

given: Thomas

family: Servoz

full_name: Clement Servoz

given: Clement

family: Derimay

full_name: François Derimay

family: Hachet

full_name: Olivier Hachet

given: Olivier

family: Motreff

full_name: Pascal Motreff

given: Pascal

family: Metz

full_name: Damien Metz

given: Damien

family: Lairez

full_name: Olivier Lairez

family: Mewton

full_name: Nathan Mewton

given: Nathan

family: Belle

full_name: Loic Belle

given: Loic

family: Akodad

full_name: Mariama Akodad

given: Mariama

family: Mathivet

full_name: Thomas Mathivet

family: Ecarnot

full_name: Fiona Ecarnot

given: Fiona

family: Pollet

full_name: Justine Pollet

given: Justine

family: Danchin

full_name: Nicolas Danchin

family: Steg

full_name: Philippe-Gabriel Steg

given: Philippe-Gabriel

family: Juillière

full_name: Yves Juillière

family: Bouleti

full_name: Claire Bouleti

given: Claire

location_facility: Groupe intercommunal Le Raincy Montfermeil


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

acronym: THERMALGI

summary:
Fibromyalgia is a common health problem that causes widespread pain and tenderness (sensitive to touch). The pain and tenderness tend to come and go, and move about the body. There is no cure for fibromyalgia. Complementary and alternative therapy such as acupuncture, chiropractic and massage therapy, can be useful to manage fibromyalgia symptoms. Many of these treatments have not been well tested in patients with fibromyalgia. Fibromyalgia affect 3 to 4% of the general population and 14 % of patients with rheumatologic disease. Fibromyalgia is most common in women 90 % in many studies. It most often starts in middle adulthood. A chronic evolution occured for Fibromyalgic patients with a major alteration of quality of life.

Thermalgi is a randomized, multicentre, open label trial wich aims to evaluate the effects of spa therapy in rheumatologia on evolution of disability in daily life of patients with fibromyalgia.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Actual

ReferenceType: background

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ReferenceCitation: Baranowsky J, Klose P, Musial F, Häuser W, Dobos G, Langhorst J. Qualitative systemic review of randomized controlled trials on complementary and alternative medicine treatments in fibromyalgia. Rheumatol Int. 2009 Nov;30(1):1-21. doi: 10.1007/s00296-009-0977-5. Epub 2009 Aug 12. Review. Erratum in: Rheumatol Int. 2009 Nov;30(1):23. Haeuser, Winfried [corrected to Häuser, Winfried].. Rheumatol Int. 2009 Nov;30(1):23.

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ReferenceCitation: Bennett RM, Kamin M, Karim R, Rosenthal N. Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled study. Am J Med. 2003 May;114(7):537-45.

ReferenceCitation: Biasi G, Manca S, Manganelli S, Marcolongo R. Tramadol in the fibromyalgia syndrome: a controlled clinical trial versus placebo. Int J Clin Pharmacol Res. 1998;18(1):13-9.

ReferenceCitation: Bircan C, Karasel SA, Akgün B, El O, Alper S. Effects of muscle strengthening versus aerobic exercise program in fibromyalgia. Rheumatol Int. 2008 Apr;28(6):527-32. Epub 2007 Nov 3.

ReferenceCitation: Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M, Saraiva F, Nacci F, Thomas E, Caubère JP, Le Lay K, Taieb C, Matucci-Cerinic M. Prevalence of fibromyalgia: a survey in five European countries. Semin Arthritis Rheum. 2010 Jun;39(6):448-53. doi: 10.1016/j.semarthrit.2008.12.003. Epub 2009 Feb 27.

ReferenceCitation: Burckhardt CS, Mannerkorpi K, Hedenberg L, Bjelle A. A randomized, controlled clinical trial of education and physical training for women with fibromyalgia. J Rheumatol. 1994 Apr;21(4):714-20.

ReferenceCitation: Burckhardt CS. Multidisciplinary approaches for management of fibromyalgia. Curr Pharm Des. 2006;12(1):59-66. Review.

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ReferenceCitation: Busch AJ, Barber KA, Overend TJ, Peloso PM, Schachter CL. Exercise for treating fibromyalgia syndrome. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003786. Review.

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ReferenceCitation: Carville SF, Arendt-Nielsen L, Bliddal H, Blotman F, Branco JC, Buskila D, Da Silva JA, Danneskiold-Samsøe B, Dincer F, Henriksson C, Henriksson KG, Kosek E, Longley K, McCarthy GM, Perrot S, Puszczewicz M, Sarzi-Puttini P, Silman A, Späth M, Choy EH; EULAR. EULAR evidence-based recommendations for the management of fibromyalgia syndrome. Ann Rheum Dis. 2008 Apr;67(4):536-41. Epub 2007 Jul 20. Review. Erratum in: Ann Rheum Dis. 2015 Feb;74(2):476. Arendt-Nielsen, S [corrected to Arendt-Nielsen, L].

ReferenceCitation: Cedraschi C, Desmeules J, Rapiti E, Baumgartner E, Cohen P, Finckh A, Allaz AF, Vischer TL. Fibromyalgia: a randomised, controlled trial of a treatment programme based on self management. Ann Rheum Dis. 2004 Mar;63(3):290-6.

ReferenceCitation: Crofford LJ, Rowbotham MC, Mease PJ, Russell IJ, Dworkin RH, Corbin AE, Young JP Jr, LaMoreaux LK, Martin SA, Sharma U; Pregabalin 1008-105 Study Group. Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2005 Apr;52(4):1264-73.

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ReferenceCitation: Fioravanti A, Perpignano G, Tirri G, Cardinale G, Gianniti C, Lanza CE, Loi A, Tirri E, Sfriso P, Cozzi F. Effects of mud-bath treatment on fibromyalgia patients: a randomized clinical trial. Rheumatol Int. 2007 Oct;27(12):1157-61. Epub 2007 May 23.

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

family: Forestier

full_name: R. Forestier

given: R.

sequence: first

family: Desfour

full_name: H. Desfour

given: H.

sequence: additional

family: Tessier

full_name: J.-M. Tessier

family: Francon

full_name: A. Francon

given: A.

family: Foote

full_name: A. M. Foote

given: A. M.

family: Genty

full_name: C. Genty

given: C.

family: Rolland

full_name: C. Rolland

family: Roques

full_name: C.-F. Roques

family: Bosson

full_name: J.-L. Bosson

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of the Rheumatic Diseases

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

version: submittedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Furlan R, Colombo S, Perego F, Atzeni F, Diana A, Barbic F, Porta A, Pace F, Malliani A, Sarzi-Puttini P. Abnormalities of cardiovascular neural control and reduced orthostatic tolerance in patients with primary fibromyalgia. J Rheumatol. 2005 Sep;32(9):1787-93.

ReferenceCitation: Giske L, Vøllestad NK, Mengshoel AM, Jensen J, Knardahl S, Røe C. Attenuated adrenergic responses to exercise in women with fibromyalgia--a controlled study. Eur J Pain. 2008 Apr;12(3):351-60. Epub 2007 Sep 10.

ReferenceCitation: Guétin S, Giniès P, Siou DK, Picot MC, Pommié C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.

publisher: Ovid Technologies (Wolters Kluwer Health)

title: The Effects of Music Intervention in the Management of Chronic Pain

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ReferenceCitation: Ledingham J, Doherty S, Doherty M. Primary fibromyalgia syndrome--an outcome study. Br J Rheumatol. 1993 Feb;32(2):139-42.

ReferenceCitation: Lerma C, Martinez A, Ruiz N, Vargas A, Infante O, Martinez-Lavin M. Nocturnal heart rate variability parameters as potential fibromyalgia biomarker: correlation with symptoms severity. Arthritis Res Ther. 2011;13(6):R185. doi: 10.1186/ar3513. Epub 2011 Nov 16.

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ReferenceCitation: Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

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ReferenceCitation: Maindet C, Maire A, Vermorel C, Cracowski C, Rolland C, Forestier R, Comte A, Roques CF, Serra E, Bosson JL. Spa Therapy for the Treatment of Fibromyalgia: An Open, Randomized Multicenter Trial. J Pain. 2021 Aug;22(8):940-951. doi: 10.1016/j.jpain.2021.02.010. Epub 2021 Mar 4.

lead_sponsor: Association Francaise pour la Recherche Thermale

location_facility:
station thermale ALLEVARD LES BAINS
station thermale BOURBON LANCY
Station thermale URIAGE LES BAINS
station thermale AIX LES BAINS
station thermale LAMALOU LES BAINS


title: Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities

acronym: PECTUS

summary: this non-randomized prospective study of 2 longitudinal cohorts (surgical treatment group or orthopedic treatment group), will evaluate the hemodynamic repercussions of the correction (surgical and non surgical) of pectus excavatum-type thoracic deformities by measuring the cardiac output difference before and after intervention, measured by transthoracic impedancemetry, during an exercise stress test

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: Centre Jean Perrin

location_facility: CHU de Clermont-Ferrand, Médecine du sport et d'explorations fonctionnelles

location_facility: CHU de Saint-Étienne, Hôpital Bellevue, Médecine du Sport et explorations fonctionnelles

location_facility: CHU de St Etienne, Hôpital Nord, Chirurgie thoracique

location_facility: CHU G Montpied, Service de Cardiologie et Maladies Vasculaires

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Completed


title: Immunopathology of Autoimmune Hemolytic Anemia: an Open, Prospective and Multicenter Study

acronym: IAHAI

summary:
Autoimmune hemolytic anemia (AIHA) is an auto-immune disease mediated by specific antibodies targeting red blood cells. Its pathogenesis is not completely understood, and the role of T cells have been rarely studied.

The aim of this study is to compare the frequency of circulating T cells, T cell polarization and functions, notably regulatory T cells, during warm AIHA by comparison to healthy controls.

The role of treatments, such as steroids, will also be determined in patients with warm AIHA.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Audia S, Bach B, Samson M, Lakomy D, Bour JB, Burlet B, Guy J, Duvillard L, Branger M, Leguy-Seguin V, Berthier S, Michel M, Bonnotte B. Venous thromboembolic events during warm autoimmune hemolytic anemia. PLoS One. 2018 Nov 8;13(11):e0207218. doi: 10.1371/journal.pone.0207218. eCollection 2018.

family: Audia

full_name: Sylvain Audia

given: Sylvain

family: Bach

full_name: Benoit Bach

given: Benoit

family: Samson

full_name: Maxime Samson

given: Maxime

family: Lakomy

full_name: Daniela Lakomy

given: Daniela

family: Bour

full_name: Jean-Baptiste Bour

given: Jean-Baptiste

family: Burlet

full_name: Bénédicte Burlet

given: Bénédicte

family: Guy

full_name: Julien Guy

given: Julien

family: Duvillard

full_name: Laurence Duvillard

given: Laurence

family: Branger

full_name: Marine Branger

given: Marine

family: Leguy-Seguin

full_name: Vanessa Leguy-Seguin

given: Vanessa

family: Berthier

full_name: Sabine Berthier

given: Sabine

family: Michel

full_name: Marc Michel

given: Marc

family: Bonnotte

full_name: Bernard Bonnotte

given: Bernard

currency_apc_doaj: USD

journal_name: PLOS ONE

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (semantic scholar lookup)

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CH de METZ
CH de Mâcon
CHU de DIJON
CHU de Besançon
CH de Chalon-sur-Saône

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Unknown


title: ELECTRODIAB2: Effect of an Outpatient Program of Bi-quadricipital Electrostimulation on Glucose Profile of Sedentary Patients With Type 2 Diabetes.

summary:
Prevalence of type 2 diabetes (T2D) is increasing worldwide. Lifestyle remains the cornerstone treatment for patients with T2D who are often overweight and sedentary.

Physical activity improves glucose metabolism of patients with T2D : increased glucose utilization during acute muscle activity and improved insulin sensitivity after regular training. The molecular mechanism underlying the effects of exercise on glucose metabolism involves the glucose transporter GLUT-4 which is regulated by physical activity.

Several studies and meta-analysis have showed that physical activity reduces HbA1c by 0.6% on average. In addition, other data suggest a decrease in cardiovascular morbidity and mortality through physical activity.

Recent recommendations for T2D management call for the practice of a structured type of endurance 150 minutes per week and muscle building 2 times per week. However, implementation of these recommendations is low, even when integrated into a therapeutic education program. Adherence is often transient and / or partial. In addition, many T2D subjects are unable to initiate a physical activity because of disabling complications or comorbidities or because of a major cardiorespiratory deconditioning.

Neuro-myo electrical stimulation (NMES) is a physical treatment routinely used in functional rehabilitation to improve muscle strength and volume. The metabolic effect of NMES has been little studied. A pilot study conducted by our team on a population of 18 subjects with T2D showed that a week of daily NMES sessions significantly improved insulin sensitivity of about 25% and up to 50 % for good responders. This result contrasted with the low induced energy expenditure by each 20-minute session of bi-quadricipital NMES, suggesting the possibility of a humoral or neural mechanism associated with NMES.

To complete this work, we plan a randomized cross-over trial with 3 periods (6 weeks without NMES (control), 6 weeks with 3 sessions of NMES per week and 6 weeks with 5 sessions of NMES per week) to assess the glucose profile of sedentary T2D subjects during these different periods. We hypothesize that the bi-quadricipital NMES could improve glycemic control in T2D subjects and thus represent an alternative to traditional physical activity.

status: Recruiting

lead_sponsor: University Hospital, Caen

location_facility: Clinical Research Center University Hospital Caen

intervention_type: Device

status_simplified: Ongoing


title: Inter-regional Project of the Great Western Exploration Approach for Exome Molecular Causes Severe Intellectual Disability Isolated or Syndromic

acronym: HUGODIMS

summary: Intellectual disability (ID) moderate or severe affects about one child in 250, with 3000 to 4000 new cases each year. Chromosomal or molecular pathology causes are not identified in half of the cases by current techniques. Studies show that de novo mutations are common in many different genes. The "exome" approach by high-throughput sequencing (NGS) has emerged as the technique of choice for identifying and comparing the exome of the child to the parent. We wish to evaluate this approach and its contribution in the diagnostic management of 50 patients with DI seen in genetics in 6 CHU Great West. Genomics platform IBISA / Biogenouest will provide technological and bioinformatics support this project.

lead_sponsor: Nantes University Hospital

location_facility:
Brest University Hospital
Rennes University Hospital
Tours University Hospital
Angers University Hospital
Poitiers University Hospital


ReferenceCitation: Abergel A, Metivier S, Samuel D, Jiang D, Kersey K, Pang PS, Svarovskaia E, Knox SJ, Loustaud-Ratti V, Asselah T. Ledipasvir plus sofosbuvir for 12 weeks in patients with hepatitis C genotype 4 infection. Hepatology. 2016 Oct;64(4):1049-56. doi: 10.1002/hep.28706. Epub 2016 Jul 29.

name: Department of Hepatology and Gastroenterology; Centre Hospitalier Universitaire Estaing; Université d'Auvergne; UMR CNRS 6284 Clermont-Ferrand France

family: Abergel

full_name: Armand Abergel

given: Armand

name: Department of Hepatology and Gastroenterology; Centre Hospitalier Universitaire Purpan; Toulouse France

family: Metivier

full_name: Sophie Metivier

given: Sophie

name: Centre Hépato-Biliaire, Hôpital Paul Brousse, Assistance Publique-Hôpitaux de Paris, UMR-S 1193; Université Paris-Sud; INSERM U785 Villejuif France

family: Samuel

full_name: Didier Samuel

given: Didier

family: Jiang

full_name: Deyuan Jiang

given: Deyuan

family: Kersey

full_name: Kathryn Kersey

given: Kathryn

family: Pang

full_name: Phillip S. Pang

given: Phillip S.

family: Svarovskaia

full_name: Evguenia Svarovskaia

given: Evguenia

family: Knox

full_name: Steven J. Knox

given: Steven J.

name: Department of Hepatology and Gastroenterology; Centre Hospitalier Universitaire Limoges, U850 INSERM; Université de Limoges; Limoges France

family: Loustaud-Ratti

full_name: Veronique Loustaud-Ratti

given: Veronique

name: Department of Hepatology, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris; Université Paris-Diderot and INSERM UMR1149; Clichy France

family: Asselah

full_name: Tarik Asselah

given: Tarik

journal_name: Hepatology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Abergel A, Asselah T, Metivier S, Kersey K, Jiang D, Mo H, Pang PS, Samuel D, Loustaud-Ratti V. Ledipasvir-sofosbuvir in patients with hepatitis C virus genotype 5 infection: an open-label, multicentre, single-arm, phase 2 study. Lancet Infect Dis. 2016 Apr;16(4):459-64. doi: 10.1016/S1473-3099(15)00529-0. Epub 2016 Jan 21.

family: Mo

full_name: Hongmei Mo

given: Hongmei

full_name: Phillip S Pang

given: Phillip S

full_name: Véronique Loustaud-Ratti

given: Véronique

journal_name: The Lancet Infectious Diseases

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

intervention_type: Drug

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

title: A Phase 2, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

summary: This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.


title: Screening for Sleep-disordered Breathing in Routine Cardiology Practice: Validation of the Apnea + Hypopnea Detection by an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy-defibrillator (CRT-D) With Impedance-based Respiration Sensor (ApneaScanTM)

acronym: AIRLESS

summary: The purpose of the study is to compare, three months after implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D), the apnea-hypopnea index (AHI) obtained from conventional in-lab NPSG/NPG (AHIPSG) with similar indices obtained from autoscoring algorithms of the ApneaScan™, an implantable impedance-based respiration sensor (AHIAS).

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Grenoble

location_facility:
Hôpital Trousseau
Hôpital Arnaud de Villeneuve
Hopital Barbois
CHU de Grenoble
Clinique Pasteur

intervention_type: Other


type: Other Grant/Funding Number

title: Comparison of FDG PET-CT Estimated Testis Functional Value Between Patients Having Positive Testicular Sperm Cells Extraction and Patients With a Negative Extraction, in Men With Azoospermia

acronym: AzoPredHisto

summary: Compare FDG PET-CT parameters between azoospermia patients having an extraction of sperm cells by positive testicular extraction and those with a negative extraction.

ReferenceCitation: Ferretti L, Sargos P, Gross-Goupil M, Izard V, Wallerand H, Huyghe E, Rigot JM, Durand X, Benoit G, Ferriere JM, Droupy S. Testicular-sparing surgery for bilateral or monorchide testicular tumours: a multicenter study of long-term oncological and functional results. BJU Int. 2014 Dec;114(6):860-4. doi: 10.1111/bju.12549. Epub 2014 Aug 16.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital
UHToulouse
UHBordeaux
Centre européen Georges Pompidou

intervention_type: Radiation


type: Other Identifier

title: Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Disease

acronym: MicroMICI

summary: The purpose of this study is to assess the diagnostic value of microRNAs in IBD colon (ulcerative colitis or Crohn's disease) in adults as compared to healthy controls (and non-IBD colitis)

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Robert Deré
Hôpital Saint Antoine
Hôpital Saint Louis
Hôpital Necker Enfants Malades
Hôpital Beaujon


lead_sponsor: Hospices Civils de Lyon

acronym: SOMELIA

location_facility:
CHU de Caen
Centre Hospitalier du Chinonais
CHU de Tours
CHRU de Strasbourg
Hôpital Femme Mere Enfant

ipd_sharing: No

type: EudraCT Number

source: euctr

title: Does Melatonin Restore Sleep Architecture in Autistic Children?

summary:
Although behavioral disorders origins in autistic children are still unclear, they seem to be influenced by sleep disorders. Results of studies performed on sleep quality in autistic children showed a high prevalence of sleep disorders in these children, estimated between 50 and 80% compared to children with typical development and insomnia is one of the sleep disorders most frequently reported by autistic children's parents. Others studies showed circadian rhythm disorder in autistic children which could be the consequence of genetic abnormalities in the melatonin synthesis and the melatonin role in the synaptic transmission modulation.

Melatonin by its sedative effects and its action on circadian pacemaker is a promoter of sleep proposed for insomnia treatment and circadian rhythm disorders.

Two major recent studies (not yet published) in the United States and in England seek to show the effectiveness of melatonin by testing the effects of three doses of melatonin on reducing sleep disorders.

It is therefore interesting and important to conduct a parallel study to assess the melatonin effect not only on the reduction of sleep disorders (sleep onset latency, total sleep time…), but on sleep quality (number of nocturnal awakenings).

The strength of this study lies in the combination of several measurement tools to assess the melatonin dose-effect on all parameters in both physiological (actimetrics, polysomnography), biological (dosage 24h sulfatoxymelatonin), behavioral (sleep questionnaire, index of insomnia severity, rating scale autistic disorder) as well as possible side effects.

The primary objective is to determine the most effective dose of melatonin to improve sleep quality in autistic children.


title: Deep Brain Stimulation in Patients With Chronic Treatment Resistant Depression

acronym: STHYM

summary:
Major depressive disorders are real public health issues in terms of diagnosis and treatment. Some forms of depression are chronic and resistant to treatment (TRD). In these forms suicide risk is important.

Patients with TRD are potential candidates for neurosurgical interventions to treat depression. However, psychosurgery interventions based upon lesions, showed their limitations related to 1. the large variability in neurosurgical gestures, 2. their side effects, and of course 3. the irreversible damage caused by the surgery.

Thus, deep brain stimulation (DBS) could represent an opportunity for patients suffering from TRD. Our preliminary study based upon the stimulation of the accumbens nucleus showed encouraging results. The investigators have thus planned a randomized controlled trial versus sham stimulation to confirm the therapeutic value of nucleus accumbens DBS.

lead_sponsor: Rennes University Hospital

location_facility:
CHS
APHM
CHU
APHP Pitié Salpetriere


title: Consumption of Fatty Acids, Metabolism of Adipose Tissue and Risk of Colorectal Cancer: AGARIC Case Control Study

acronym: AGARIC

summary: The aim of the study is to establish the existence of a relationship between the dietary intake of polyunsaturated fatty acids (PUFA) and the risk of colorectal cancer in humans, using 2 reliable and complementary biomarkers: the fatty acid-composition of lipids of the abdominal subcutaneous adipose tissue and the fatty acid composition of erythrocyte phospholipids.

ReferenceCitation: Cottet V, Vaysse C, Scherrer ML, Ortega-Deballon P, Lakkis Z, Delhorme JB, Deguelte-Lardière S, Combe N, Bonithon-Kopp C. Fatty acid composition of adipose tissue and colorectal cancer: a case-control study. Am J Clin Nutr. 2015 Jan;101(1):192-201. doi: 10.3945/ajcn.114.088948. Epub 2014 Nov 12.

name: From the Institut national de la santé et de la recherche médicale (INSERM) Unité mixte de recherche 866 (VC and CB-K) and INSERM CIC 1432, Clinical Epidemiology Team (CB-K), Faculté de Médecine de Dijon, Dijon, France; the Institut des Corps Gras–Equipe Nutrition Métabolisme & Santé, Talence, France (CV and NC); the Department of General and Digestive Surgery, University Hospital of Nancy, Hôpit

family: Cottet

full_name: Vanessa Cottet

given: Vanessa

family: Vaysse

full_name: Carole Vaysse

given: Carole

family: Scherrer

full_name: Marie-Lorraine Scherrer

given: Marie-Lorraine

family: Ortega-Deballon

full_name: Pablo Ortega-Deballon

given: Pablo

family: Lakkis

full_name: Zaher Lakkis

given: Zaher

family: Delhorme

full_name: Jean-Baptiste Delhorme

given: Jean-Baptiste

family: Deguelte-Lardière

full_name: Sophie Deguelte-Lardière

family: Combe

full_name: Nicole Combe

given: Nicole

family: Bonithon-Kopp

full_name: Claire Bonithon-Kopp

given: Claire

journal_name: The American Journal of Clinical Nutrition

oa_host_type: publisher

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

location_facility:
Hôpital de BRABOIS
CHU Jean Minjoz
Hôpital Robert Debré
CHU Dijon
Hôpital Hautepierre


title: Prevalence of Obesity Hypoventilation Syndrome in Subjects With Obesity Referred to Clinical (Medical Analysis) Laboratories for Regular Follow-up

acronym: BIO-OHS

summary:
Rationale of the "BIO-OHS" study (Prevalence of Obesity Hypoventilation Syndrome):

The overall prevalence of Obesity Hypoventilation Syndrome (OHS) has never been directly assessed in the general population. Actually, this prevalence has been assessed in patients referred to sleep clinics with a potential diagnosis of sleep-disordered breathing or in patients already diagnosed with sleep apnea. The purpose of this study is to determine the prevalence of Obesity Hypoventilation syndrome in obese patients referred to clinical laboratories for regular follow-up medical analysis.

lead_sponsor: AGIR à Dom

location_facility: Laboratoire d'analyses medicales de Thuir

location_facility: Hôpital Michallon, Laboratoire EFCR et Sommeil


title: Glycemic Control Assessed by Continuous Glucose Monitoring in Hemodialyzed Patients With Diabetes Mellitus Treated Via the Basal-Bolus Detemir-Aspart Insulin Regimen: A Pilot Study

acronym: GlyCEDIA

summary: The purpose of the study is to evaluate the effect of the basal-bolus detemir-aspart insulin regimen coupled with continuous glucose monitoring (CGM) on glycemic control in hemodialyzed patients with diabetes

ReferenceCitation: U S Renal Data System, USRDS 2012 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2012. Available from http://www.usrds.org/atlas.aspx

ReferenceCitation: Heras M, Fernández-Reyes MJ, Sánchez R, Guerrero MT, Molina A, Rodríguez MA, Alvarez-Ude F. Elderly patients with chronic kidney disease: outcomes after 5 years of follow-up. Nefrologia. 2012 May 14;32(3):300-5. doi: 10.3265/Nefrologia.pre2012.Jan.10994. Epub 2012 Feb 28. English, Spanish.

ReferenceCitation: Pieringer H, Biesenbach G. Hemodialysis in patients older than 65 years with end-stage renal failure--comparison of outcome in patients with and without diabetes. Z Gerontol Geriatr. 2008 Apr;41(2):139-45. doi: 10.1007/s00391-007-0467-x. Epub 2008 Mar 11.

ReferenceCitation: Sattar A, Argyropoulos C, Weissfeld L, Younas N, Fried L, Kellum JA, Unruh M. All-cause and cause-specific mortality associated with diabetes in prevalent hemodialysis patients. BMC Nephrol. 2012 Oct 1;13:130. doi: 10.1186/1471-2369-13-130.

ReferenceCitation: Oomichi T, Emoto M, Tabata T, Morioka T, Tsujimoto Y, Tahara H, Shoji T, Nishizawa Y. Impact of glycemic control on survival of diabetic patients on chronic regular hemodialysis: a 7-year observational study. Diabetes Care. 2006 Jul;29(7):1496-500.

ReferenceCitation: Diabetes Control and Complications Trial Research Group, Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86.

ReferenceCitation: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. Erratum in: Lancet 1999 Aug 14;354(9178):602.

ReferenceCitation: McMurray SD, Johnson G, Davis S, McDougall K. Diabetes education and care management significantly improve patient outcomes in the dialysis unit. Am J Kidney Dis. 2002 Sep;40(3):566-75.

ReferenceCitation: Okada T, Nakao T, Matsumoto H, Shino T, Nagaoka Y, Tomaru R, Wada T. Association between markers of glycemic control, cardiovascular complications and survival in type 2 diabetic patients with end-stage renal disease. Intern Med. 2007;46(12):807-14. Epub 2007 Jun 15.

ReferenceCitation: Action to Control Cardiovascular Risk in Diabetes Study Group, Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6.

ReferenceCitation: ACCORD Study Group, Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14.

ReferenceCitation: Riveline JP, Teynie J, Belmouaz S, Franc S, Dardari D, Bauwens M, Caudwell V, Ragot S, Bridoux F, Charpentier G, Marechaud R, Hadjadj S. Glycaemic control in type 2 diabetic patients on chronic haemodialysis: use of a continuous glucose monitoring system. Nephrol Dial Transplant. 2009 Sep;24(9):2866-71. doi: 10.1093/ndt/gfp181. Epub 2009 Apr 23.

ReferenceCitation: Kazempour-Ardebili S, Lecamwasam VL, Dassanyake T, Frankel AH, Tam FW, Dornhorst A, Frost G, Turner JJ. Assessing glycemic control in maintenance hemodialysis patients with type 2 diabetes. Diabetes Care. 2009 Jul;32(7):1137-42. doi: 10.2337/dc08-1688. Epub 2009 Feb 5.

ReferenceCitation: Vos FE, Schollum JB, Coulter CV, Manning PJ, Duffull SB, Walker RJ. Assessment of markers of glycaemic control in diabetic patients with chronic kidney disease using continuous glucose monitoring. Nephrology (Carlton). 2012 Feb;17(2):182-8. doi: 10.1111/j.1440-1797.2011.01517.x.

ReferenceCitation: Ersoy A, Ersoy C, Altinay T. Insulin analogue usage in a haemodialysis patient with type 2 diabetes mellitus. Nephrol Dial Transplant. 2006 Feb;21(2):553-4. Epub 2005 Oct 12.

ReferenceCitation: Schmitz O, Alberti KG, Orskov H. Insulin resistance in uraemic insulin-dependent diabetics. Effect of dialysis therapy as assessed by the artificial endocrine pancreas. Acta Endocrinol (Copenh). 1984 Mar;105(3):371-8.

ReferenceCitation: Simic-Ogrizovic S, Backus G, Mayer A, Vienken J, Djukanovic L, Kleophas W. The influence of different glucose concentrations in haemodialysis solutions on metabolism and blood pressure stability in diabetic patients. Int J Artif Organs. 2001 Dec;24(12):863-9.

ReferenceCitation: Biesenbach G, Raml A, Schmekal B, Eichbauer-Sturm G. Decreased insulin requirement in relation to GFR in nephropathic Type 1 and insulin-treated Type 2 diabetic patients. Diabet Med. 2003 Aug;20(8):642-5.

ReferenceCitation: Cano N. Bench-to-bedside review: glucose production from the kidney. Crit Care. 2002 Aug;6(4):317-21. Epub 2002 Jun 7. Review.

ReferenceCitation: Cersosimo E, Garlick P, Ferretti J. Renal substrate metabolism and gluconeogenesis during hypoglycemia in humans. Diabetes. 2000 Jul;49(7):1186-93.

ReferenceCitation: Abe M, Kaizu K, Matsumoto K. Evaluation of the hemodialysis-induced changes in plasma glucose and insulin concentrations in diabetic patients: comparison between the hemodialysis and non-hemodialysis days. Ther Apher Dial. 2007 Aug;11(4):288-95.

ReferenceCitation: Chujo K, Shima K, Tada H, Oohashi T, Minakuchi J, Kawashima S. Indicators for blood glucose control in diabetics with end-stage chronic renal disease: GHb vs. glycated albumin (GA). J Med Invest. 2006 Aug;53(3-4):223-8.

ReferenceCitation: Holmes G, Galitz L, Hu P, Lyness W. Pharmacokinetics of insulin aspart in obesity, renal impairment, or hepatic impairment. Br J Clin Pharmacol. 2005 Nov;60(5):469-76.

ReferenceCitation: Rave K, Heise T, Pfützner A, Heinemann L, Sawicki PT. Impact of diabetic nephropathy on pharmacodynamic and Pharmacokinetic properties of insulin in type 1 diabetic patients. Diabetes Care. 2001 May;24(5):886-90.

ReferenceCitation: Morello CM. Pharmacokinetics and pharmacodynamics of insulin analogs in special populations with type 2 diabetes mellitus. Int J Gen Med. 2011;4:827-35. doi: 10.2147/IJGM.S26889. Epub 2011 Dec 12.

ReferenceCitation: Meneghini LF, Rosenberg KH, Koenen C, Merilainen MJ, Lüddeke HJ. Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naive or treated with NPH or insulin glargine: clinical practice experience from a German subgroup of the PREDICTIVE study. Diabetes Obes Metab. 2007 May;9(3):418-27.

ReferenceCitation: Marshall J, Jennings P, Scott A, Fluck RJ, McIntyre CW. Glycemic control in diabetic CAPD patients assessed by continuous glucose monitoring system (CGMS). Kidney Int. 2003 Oct;64(4):1480-6.

ReferenceCitation: Tzamaloukas AH, Yuan ZY, Murata GH, Balaskas E, Avasthi PS, Oreopoulos DG. Clinical associations of glycemic control in diabetics on CAPD. Adv Perit Dial. 1993;9:291-4.

ReferenceType: result

ReferenceCitation: Shurraw S, Hemmelgarn B, Lin M, Majumdar SR, Klarenbach S, Manns B, Bello A, James M, Turin TC, Tonelli M; Alberta Kidney Disease Network. Association between glycemic control and adverse outcomes in people with diabetes mellitus and chronic kidney disease: a population-based cohort study. Arch Intern Med. 2011 Nov 28;171(21):1920-7. doi: 10.1001/archinternmed.2011.537.

family: Shurraw

full_name: Sabin Shurraw

given: Sabin

journal_name: Archives of Internal Medicine

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Association Between Glycemic Control and Adverse Outcomes in People With Diabetes Mellitus and Chronic Kidney Disease

ReferenceCitation: Hendriksen KV, Jensen T, Oturai P, Feldt-Rasmussen B. Effects of insulin detemir and NPH insulin on renal handling of sodium, fluid retention and weight in type 2 diabetic patients. Diabetologia. 2012 Jan;55(1):46-50. doi: 10.1007/s00125-011-2345-8. Epub 2011 Oct 16.

family: Hendriksen

full_name: K. V. Hendriksen

given: K. V.

family: Jensen

full_name: T. Jensen

given: T.

family: Oturai

full_name: P. Oturai

given: P.

family: Feldt-Rasmussen

full_name: B. Feldt-Rasmussen

given: B.

journal_name: Diabetologia

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Centre Europeen d'Etude du Diabete

location_facility:
Regional Hospital of Valenciennes
Sainte Anne Hospital
Regional Hospital of Mulhouse
Regional Hospital of Colmar
University Hospital of Strasbourg


title: Efficacy and Safety of Circular Cyclocoagulation Using High Intensity Focused Ultrasound With EYEOP1 Device in Glaucoma Patients. Prospective Multicenter Clinical Trial.

summary: The aim of the study is to evaluate the effectiveness and the safety of the cyclocoagulation using HIFU in glaucoma patients

lead_sponsor: EyeTechCare

location_facility:
Michallon University Hospital
Croix Rousse University Hospital
HIA - Val de Grace Hospital
University Hospital
Huriez University Hospital


title: Preventing Nephropathy Induced by Iodinated Contrast Media in Patients With Renal Impairment: a Randomized Trial Evaluating the Effectiveness of Two Hydration Strategies and L-carnitine Administration

acronym: CinBiCarn

summary: The general objective of this open, pilot study is to characterize biological parameters related to acute kidney injury among patients undergoing a programmed coronarography with injection of contrast material. The study focuses on two main factors that may influence acute kidney injury: (1) sodium chloride hydration strategy versus sodium bicarbonate hydration strategy and (2) presence of oral L-carnitine treatment versus absence of oral L-carnitine treatment. We will also test for a potential interaction between these two factors.

status: Terminated

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CH d'Avignon - Centre Hospitalier Henri Duffaut

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Adipocyte, Insulin-resistance and Immunity : Evaluation of Interleukin-7 in Lipodystrophies According to Fat Mass and Glucose Metabolism

summary: White adipose tissue-related diseases spread from excess (obesity) to lack (lipoatrophies) through aberrant distribution (lipodystrophies), these 3 different disorders being paradoxically able to induce a metabolic insulin resistance syndrome. The respective part of quantitative and qualitative anomalies of adipose tissue, gluco- and lipo-toxicity, liver and muscle insulin resistance, low-grade fat inflammation and immune alterations are not perfectly understood in the metabolic syndrome yet. Therefore, the aim of this study is to assess different cytokines, especially interleukin 7, and metabolic parameters as well as fat mass distribution with DEXA and RMN, in different models of fat distribution, including normal-weight, obese and lipodystrophic patients. A plasma serum, gene and adipose tissue bank will be constituted at the same time to improve our knowledge in disorders linking fat mass, insulin resistance and immunity, especially in lipodystrophies, a rare monogenic model of insulin resistance.

time_perspective: Cross-Sectional

ReferenceCitation: Lemaitre M, Chevalier B, Jannin A, Le Mapihan K, Boury S, Lion G, Labalette M, Vantyghem MC. Metabolic and immunological phenotype of rare lipomatoses: Dercum's disease and Roch-Leri mesosomatic lipomatosis. Orphanet J Rare Dis. 2021 Jun 29;16(1):290. doi: 10.1186/s13023-021-01920-3.

family: Lemaitre

full_name: Madleen Lemaitre

given: Madleen

family: Chevalier

full_name: Benjamin Chevalier

given: Benjamin

family: Jannin

full_name: Arnaud Jannin

given: Arnaud

family: Le Mapihan

full_name: Kristell Le Mapihan

given: Kristell

family: Boury

full_name: Samuel Boury

given: Samuel

family: Lion

full_name: Georges Lion

given: Georges

family: Labalette

full_name: Myriam Labalette

given: Myriam

family: Vantyghem

full_name: Marie-Christine Vantyghem

given: Marie-Christine

currency_apc_doaj: GBP

journal_name: Orphanet Journal of Rare Diseases

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

repository_institution: Research Square - Research Square

repository_normalized: Research Square

repositories:
PubMed Central
Research Square

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

title: Metabolic and immunological phenotype of rare lipomatoses: Dercum’s disease and Roch-Leri mesosomatic lipomatosis

lead_sponsor: University Hospital, Lille

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


status: Active, not recruiting

lead_sponsor: UNICANCER

acronym: CARLHA

location_facility: Institut de Cancérologie de l'ouest/René Gauducheau

title: Safety and Efficacy of Radiotherapy Combined With a 6-month LH-RH Agonist and Abiraterone Hormone Therapy Treatment in Biochemically-relapsing Prostate Cancer Following Surgery

summary:
As there is no prospective data on the combination of abiraterone and salvage radiotherapy, the aim of this study is to further evaluate the safety profile of abiraterone acetate plus prednisone in patients with prostate cancer who are biochemically relapsing after surgery and undergo salvage radiotherapy with 6-months LH-RH agonist.

The investigators hypothesize that the toxicity profile of both treatments should not potentiate each other. This study will also provide preliminary data on the efficacy of this combination.


title: Program to Establish the Genetic and Immunologic Profile of Patient's Tumor for All Types of Advanced Cancer

acronym: PROFILER

summary:
It is a non-randomized, multicentric, cohort study, combined with a biological sample collection, a clinical data collection and with a genetic and immunologic biomarkers study.

The ProfiLER program aims to implement a personalized cancer medicine approach by proposing to establish the genetic and immunologic profile of the tumor for patients with an advanced malignant tumor, in order to define a map of genetic (for the pre-identified target genes) and immunologic profiles for all the studied types of cancer. This study will also allow adapting the therapeutic management of these patients, if needed, by giving them targeted therapies or immunotherapies (commercialized on in ongoing clinical trials), based on the recommendations of the multidisciplinary molecular board.

The genetic and immunologic profile of the tumor will be determined from archival or fresh collected (biopsy of a reachable lesion) tumor sample and from a blood sample. The correlation between genetic profiles of the tumor, patients immunity status and clinical data (progression, tumor response, etc.) collected from the patient medical records will probably allow us to identify biomarkers with a potential predictive value and to determine if some genetic disorders are linked to immunity status alterations.

ReferenceCitation: Stratton MR, Campbell PJ, Futreal PA. The cancer genome. Nature. 2009 Apr 9;458(7239):719-24. doi: 10.1038/nature07943. Review.

ReferenceCitation: Diaz-Cano SJ. General morphological and biological features of neoplasms: integration of molecular findings. Histopathology. 2008 Jul;53(1):1-19. doi: 10.1111/j.1365-2559.2007.02937.x. Epub 2008 Feb 12. Review.

ReferenceCitation: Dancey JE, Bedard PL, Onetto N, Hudson TJ. The genetic basis for cancer treatment decisions. Cell. 2012 Feb 3;148(3):409-20. doi: 10.1016/j.cell.2012.01.014. Review.

ReferenceCitation: Chin L, Hahn WC, Getz G, Meyerson M. Making sense of cancer genomic data. Genes Dev. 2011 Mar 15;25(6):534-55. doi: 10.1101/gad.2017311. Review. Erratum in: Genes Dev. 2012 May 1;26(9):1003.

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family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Cropet

full_name: Claire Cropet

family: Van Glabbeke

full_name: Martine Van Glabbeke

given: Martine

family: Sebban

full_name: Catherine Sebban

given: Catherine

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

family: Judson

full_name: Ian Judson

given: Ian

family: Tredan

full_name: Olivier Tredan

given: Olivier

family: Verweij

full_name: Jaap Verweij

given: Jaap

family: Biron

full_name: Pierre Biron

given: Pierre

family: Labidi

full_name: Inthidar Labidi

given: Inthidar

family: Guastalla

full_name: Jean-Paul Guastalla

given: Jean-Paul

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Perol

full_name: David Perol

given: David

family: Chabaud

full_name: Sylvie Chabaud

given: Sylvie

family: Hogendoorn

full_name: Pancras C.W. Hogendoorn

given: Pancras C.W.

family: Cassier

full_name: Philippe Cassier

given: Philippe

family: Dufresne

full_name: Armelle Dufresne

given: Armelle

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

journal_name: Cancer Research

publisher: American Association for Cancer Research (AACR)

title: Lymphopenia as a Prognostic Factor for Overall Survival in Advanced Carcinomas, Sarcomas, and Lymphomas

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title: Differences in Tumor Regulatory T-Cell Localization and Activation Status Impact Patient Outcome: Figure 1.

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repository_institution: The University of Manchester - Research Explorer

title: Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation

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name: Department of Translational Research, Centre Leon Berard, 69008 Lyon France

name: Department of Medical Oncology, Centre Leon Berard, 69008 Lyon France

name: Department of Pathobiology, Centre Leon Berard, 69008 Lyon France

name: Department of Clinical Research, Centre Leon Berard, 69008 Lyon France

name: Department of Surgery, Centre Leon Berard, 69008 Lyon France

name: Department of Medical Oncology, Gustave Roussy, 94805, Villejuif France

name: Department of Medical Oncology, Centre Oscar Lambret, 59020 Lille France

location_facility: Institut de cancérologie LUCIEN NEUWIRTH


title: Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis

acronym: SEWORRA

summary: To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients treated by rituximab.

lead_sponsor: University Hospital, Rouen

location_facility:
Department of Rheumatology CHG Elbeuf
Department of Rheumatology
Normandy
Department of Rheumatology, CHU de Caen
Department of rheumatology


title: First in Man Safety Evaluation of the ART18Z Bioresorbable Stent for the Treatment of Single de Novo Lesion of a Native Coronary Artery.

summary: This prospective, multicentre, open labeled, single arm, first in man interventional investigation aims to evaluate the safety of the ART18Z bioresorbable stent for the treatment of patients with single de novo lesion of a native coronary artery with mandatory balloon predilatation.

lead_sponsor: Arterial Remodeling Technologies

location_facility:
Hôpital Européen Georges Pompidou
Hôpital Haut Leveque
Hôpital Rangueil
Clinique Pasteur
Polyclinique les Fleurs


title: Diagnostic, Prospective, Comparative, Multicentric Study of the PET / CT With 68Ga-DOTANOC Versus Conventional Imaging Procedures (octréoscan ® Scintigraphy and CT / MRI) in the Assessment of in Gastroenteropancreatic Neuroendocrine Tumors

summary:
Evaluation of the diagnostic performance of PET / CT with 68Ga-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors with comparison with other techniques used in routine clinical practice (octreoscan ® ; multiphase SPECT / CT, MRI or endoscopy).

Therapeutic impact and safety of PET / CT with 68Ga-DOTANOC will also be assessed. Expected results are a confirmation of the superiority of 68Ga-PET DOTANOC versus scintigraphy octreoscan ®, with a potential impact on the therapeutic management of patients.

location_facility: Institut de Cancérologie de l'Ouest, René Gauducheau


title: PROSPECTIVE VALIDATION OF A PREDICTIVE MODEL OF RESPONSE TO ROMIPLOSTIM IN PATIENTS WITH IPSS LOW OR INTERMEDIATE-1 RISK MYELODYSPLASTIC SYNDROME (MDS) AND THROMBOCYTOPENIA - THE EUROPE-TRIAL

acronym: EUROPE

summary: There are currently no licensed drugs in the EU to treat thrombocytopenia in MDS patients classified as IPSS low/int-1. Prior studies with romiplostim (a TPO receptor agonist) in MDS found that baseline concentration of TPO as well as transfusion history were predictive of subsequent response in a retrospective model. The current prospective study has the aim to explore whether both pretreatment variables (endogenous TPO, TPO-level, platelet transfusion history) can predict the response to subsequent short-term treatment with romiplostim.

lead_sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

location_country: Germany France

location_facility: Marienhospital Düsseldorf GmbH / Innere Medizin u. Hämatologie

location_facility: Medizinische Hochschule Hannover / Hämatologie u. Onkologie

location_facility: Universitätsklinikum Hamburg-Eppendorf /Onkologisches Zentrum

location_facility: MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim

location_facility: Vivantes Klinikum am Urban / Hämatologie Onkologie

location_facility: Universitätsklinikum Mannheim / Klinik III / Hämatologie, Onkologie

location_facility: Universitätsklinikum Ulm / Klinik Innere Medizin III

location_facility: Universitätsklinikum Halle (Saale) / Klinik für Innere Medizin IV

location_facility: Rems-Murr-Kliniken Winnenden / Hämatologie, Onkologie

location_facility: Klinikum Rechts der Isar, Tumortherapiezentrum

location_facility: Universitätsklinikum Dresden / Medizinische Klinik I

location_facility: Klinikum Chemnitz gGmbH / Klinik für Innere Medizin III


title: Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome

acronym: MENT-APL-O

summary: The main objective of this study is to estimate the lifetime prevalence of major psychiatric disorders (axis I DSM-IV; Diagnostic and Statistical Manual of Mental Disorders, version IV) in a large sample of patients with developed clinical signs of pure obstetrical antiphospholipid syndrome (suspected APS).

primary_purpose: Basic Science

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: A Phase II Study of Cetuximab Rechallenge in Combination With Irinotecan in Advanced Metastatic Colorectal Cancer Without KRAS or NRAS or BRAF Mutation (All Wild Type) for Patients Pretreated With FOLFIRI and Cetuximab in First Line With Stopping Cetuximab for Progressive Disease After a Previous Response (Partial Response or Complete Response) and After Treatment With a Fluoropyrimidine, Oxaliplatin Plus Bevacizumab Regimen

acronym: REGAIN

summary:
The main objective of this study is to evaluate the objective response rate at two months (complete disappearance of the disease and partial disappearance of the disease) obtained after administration of combination therapy with cetuximab and irinotecan in the patients with metastatic colorectal cancer.

Secondaries objectives will be assessed progression-free survival, overall survival, toxicity, quality of life.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Groupe hospitalier Public du Sud de l'Oise -site de Senlis

location_facility: Centre de radiothérapie - Clinique Sainte Anne


title: Therapeutic Nipple Areola Skin-sparing Mastectomy.

summary:
This is a phase III, multicentric, single arm study with a sequential design using the exact conditional Poisson test.

The primary objective of this prospective study is to evaluate whether selected breast carcinoma patients could be treated with nipple sparing mastectomy (NSM) with an acceptable low local recurrence rates.

450 patients will be included over a period of 4 years and will be followed for a 5 years period (twice a year).

All patients must have a complete preoperative evaluation (bilateral mammography, bilateral breast ultrasonography +/- MRI), and a histopathological diagnostic proof of carcinoma (invasive or in situ, all histopathological types, first treatment or relapse).

The study procedure is represented by nipple areola skin-sparing mastectomy followed by immediate breast reconstruction.

After surgery, early and late complications, including specific complications (suffering of the nipple-areolar complexe and suffering of the skin flaps), will be evaluate.

An esthetic evaluation (by patient and clinician) and a quality of life evaluation will be realized throughout the study.

A complementary study, prospective, non-interventional, will be proposed to patients who will benefit from the same surgical technique (NSM) followed by immediate reconstruction, but in the context of preventive surgery (prophylactic surgery for patients mutated or high genetic risk). The aim of this complementary study, which will include a maximum of 60 patients, is to evaluate associated morbidity in prophylactic NSM.

Data will be collected over a 3 months period after surgery.

ReferenceCitation: Filleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30.

family: Filleron

full_name: T. Filleron

given: T.

family: Lusque

full_name: A. Lusque

given: A.

family: Dalenc

full_name: F. Dalenc

given: F.

family: Ferron

full_name: G. Ferron

given: G.

family: Roche

full_name: H. Roche

given: H.

family: Martinez

full_name: A. Martinez

family: Jouve

full_name: E. Jouve

given: E.

journal_name: Contemporary Clinical Trials

lead_sponsor: Institut Claudius Regaud

location_facility: Hôpital Européen Georges Pompidou, Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Etablissement Rennais du Sein - CHP St Grégoire

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: INSTITUT DE CANCEROLOGIE DE L'OUEST - Site René Gauducheau


title: A Randomized Phase III Trial Evaluating Two Strategies of Rituximab Administration for the Treatment of First Line/Low Tumor Burden Follicular Lymphoma (Follicular Lymphoma IV/SC Rituximab Therapy)

acronym: FLIRT

summary:
Patient will receive either one infusion of rituximab IV and seven administrations of rituximab SC (experimental arm) or four infusions of rituximab IV (standard arm).

The hypothesis is that the use of rituximab by sub cutaneous route and the scheme of administration could:

optimize rituximab exposure leading to improve response rate
increase adaptative response and then improve long-term control disease.

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Hôpital Haut Lévêque - Centre François Magendie

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau

location_facility: Institut de Cancérologie du Gard Hématologie clinique


title: A Multicenter Open Label Phase 2 Study of Carfilzomib Weekly Plus Melphalan and Prednisone in Untreated Symptomatic Elderly Multiple Myeloma

summary: IFM 2012-03 protocol is a Phase 2 multicenter nonrandomized open in elderly patients with multiple myeloma at diagnosis. Study primary objectives are in the first step to determine Maximum tolerated dose (MTD) of Carfilzomib Weekly based on definition of Dose-limiting toxicities (DLTs) and in the second step to expanded cohort, to determine the VGPR (Very Good Partial Response) + CR (Complete Response) rate of Carfilzomib Weekly at the MTD in combination with Melphalan Prednisone at the end of the 9 induction cycles.

location_facility: Hématologie Clinique, Hôpital Robert Debré, CHU Reims

location_facility: Unité de Recherche Clinique - CH Perigueux

location_facility: Hématologie Clinique, CHU, Hôpital d'Enfants

location_facility: Centre hospitalier départemental La Roche sur Yon


ReferenceCitation: Mosele F, Stefanovska B, Lusque A, Tran Dien A, Garberis I, Droin N, Le Tourneau C, Sablin MP, Lacroix L, Enrico D, Miran I, Jovelet C, Bièche I, Soria JC, Bertucci F, Bonnefoi H, Campone M, Dalenc F, Bachelot T, Jacquet A, Jimenez M, André F. Outcome and molecular landscape of patients with PIK3CA-mutated metastatic breast cancer. Ann Oncol. 2020 Mar;31(3):377-386. doi: 10.1016/j.annonc.2019.11.006. Epub 2020 Jan 24.

family: Mosele

full_name: F. Mosele

family: Stefanovska

full_name: B. Stefanovska

given: B.

family: Tran Dien

full_name: A. Tran Dien

family: Garberis

full_name: I. Garberis

given: I.

family: Droin

full_name: N. Droin

given: N.

family: Le Tourneau

full_name: C. Le Tourneau

given: C.

family: Sablin

full_name: M.-P. Sablin

family: Lacroix

full_name: L. Lacroix

given: L.

family: Enrico

full_name: D. Enrico

given: D.

family: Miran

full_name: I. Miran

family: Jovelet

full_name: C. Jovelet

family: Bièche

full_name: I. Bièche

family: Soria

full_name: J.-C. Soria

family: Bertucci

full_name: F. Bertucci

family: Bonnefoi

full_name: H. Bonnefoi

family: Campone

full_name: M. Campone

given: M.

full_name: T. Bachelot

family: Jacquet

full_name: A. Jacquet

family: Jimenez

full_name: M. Jimenez

family: André

full_name: F. André

journal_name: Annals of Oncology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

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

location_facility: Hopitaux Universitaire de Strasbourg - Hopital Civil

location_facility: Institut de Cancérologie de l'Ouest/ René Gauducheau

location_facility: Institut Régional du Cancer Montpellier Val d'Aurelle

title: PERSONALIZED MEDICINE GROUP / UCBG UC-0105/1304: SAFIR02_Breast - Evaluation of the Efficacy of High Throughput Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer

summary: Open label multicentric phase II randomized trial, using high throughput genome analysis as a therapeutic decision tool, which aims at comparing a targeted treatment administered according to the identified molecular anomalies of the tumor with maintenance chemotherapy (targeted substudy 1) as well as immunotherapy with maintenance chemotherapy in patients without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2).


location_facility:
Hôpital Henri Mondor
Hôpital André Mignot
CHU de Strasbourg
Hôpital de la Conception
Centre Henri Becquerel
Hôpital Haut Lévêque
CHU de Brabois
CH Perpignan
I.U.C.T Oncopole
Hôpital de la Pitié Salpétrière
CHU Robert Debre
CHU de Nantes
CHRU Lille - Hôpital Claude Huriez
CHU Pontchaillou
Institut Paoli Calmette
Hôpital Cochin
Gustave Roussy Cancer Campus
CHU Bretonneau
Clinique Victor Hugo
CHU de Dijon - Hôpital le Bocage
CH Sud Francilien
Centre Léon Bérard
Centre François Baclesse
CHU Montpellier - Saint ELOI
Hôpital Saint Louis
CH de Chambéry
CHU de Limoges
CH Victor Dupouy
Polyclinique Bordeaux Nord
CHU Lyon Sud

title: Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II Hodgkin's Lymphoma and FDG-PET Positivity After 2 Cycles of ABVD

summary: This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in patients with stage I/II Hodgkin's lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine).


title: Retrospective Multicenter Observational Study in NSCLC Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutation Treated First Line by Tyrosine Kinase Inhibitor (TKI)

acronym: EGFR-RETRO

summary: The purpose of our retrospective study is to describe which circumstances EGFR TKI is continued despite progression according to the usual Response Evaluation CrIteria in Solid Tumours (RECIST) in patients with EGFR activating mutations and acquired resistance to EGFR TKI .We will collect their social and demographic data (age, sex), first Progression Free Survival ( PFS) - from start of EGFR TKI to 1st progression PFS 1- and - from first progression according to RECIST to second progression : PFS2- , Overall Survival (OS) - from diagnosis OS 1 and from first progression OS 2 -, mutational status. We will analyze more closely the mode of progression (site), the therapeutic approach at disease progression. We will define two subgroups: those for whom EGFR TKI was continued at least three months despite progression defined according to RECIST criteria, and those for whom a second-line treatment (chemotherapy without EGFR TKI) was chosen at disease progression. It will be individualized the subgroup of patients in whom it was continued TKI after progression.

time_perspective: Retrospective

ReferenceCitation: Auliac JB, Fournier C, Audigier Valette C, Perol M, Bizieux A, Vinas F, Decroisette Phan van Ho C, Bota Ouchlif S, Corre R, Le Garff G, Fournel P, Baize N, Lamy R, Vergnenegre A, Arpin D, Marin B, Chouaid C, Gervais R. Impact of Continuing First-Line EGFR Tyrosine Kinase Inhibitor Therapy Beyond RECIST Disease Progression in Patients with Advanced EGFR-Mutated Non-Small-Cell Lung Cancer (NSCLC): Retrospective GFPC 04-13 Study. Target Oncol. 2016 Apr;11(2):167-74. doi: 10.1007/s11523-015-0387-4.

family: Auliac

full_name: J. B. Auliac

given: J. B.

family: Fournier

full_name: C. Fournier

family: Audigier Valette

full_name: C. Audigier Valette

family: Perol

full_name: M. Perol

family: Bizieux

full_name: A. Bizieux

family: Vinas

full_name: F. Vinas

family: Decroisette Phan van Ho

full_name: C. Decroisette Phan van Ho

family: Bota Ouchlif

full_name: S. Bota Ouchlif

given: S.

family: Corre

full_name: R. Corre

given: R.

family: Le Garff

full_name: G. Le Garff

family: Fournel

full_name: P. Fournel

given: P.

family: Baize

full_name: N. Baize

family: Lamy

full_name: R. Lamy

family: Vergnenegre

full_name: A. Vergnenegre

family: Arpin

full_name: D. Arpin

family: Marin

full_name: B. Marin

family: Chouaid

full_name: C. Chouaid

family: Gervais

full_name: R. Gervais

journal_name: Targeted Oncology

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility:
Site 32
Site 07
Site 11
Centre Hospitalier D Argenteuil
Site 00
Centre Hospitalier Régional
Centre Hospitalier du Morvan
Site 12
Centre Hospitalier Universitaire
Site 01
Centre Hospitalier René Dubos
Site 06
Site 20
Site 33
Hôpital Yves Le Foll
Site 14
Centre Hospitalier Les Oudairies
Site 19
Hospital du Cluzeau
Centre François Baclesse
Site 18
Site 17
Site 04
Site 25


summary: This non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice. Patients with HER2-positive early breast cancer, naive and non-naive of HER2+ treatment who are to be treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with Herceptin SC in routine clinical practice use are eligible to participate. The total study duration is anticipated to be 38 months.

lead_sponsor: Hoffmann-La Roche

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Ch Du Mans; Medecine Hematologie Oncologie

location_facility: CH Carcassonne; Service Onco Hematologie

location_facility: Polyclinique Du Languedoc; Chimiotherapie

location_facility: Ch De Montlucon; Hematologie Cancerologie

location_facility: Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente

location_facility: Hopital Louis Pasteur; Oncologie Hematologie

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie

location_facility: CH de Marne la vallee; Oncologie Medicale

location_facility: Clinique Medico Chir Charcot; Chir Cancerologie

location_facility: Clinique Tivoli; Chimiotherapie Radiotherapie

location_facility: Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie

location_facility: Clinique De L Estree; Oncologie Medicale

location_facility: CH de Saint Jean De Maurienne; Had St Jean De Maurienne

location_facility: Clinique Saint Jean Languedoc; Oncologie Medicale

location_facility: Clinique Claude Bernard; Onco Hematologie

location_facility: Centre Hospitalier De Sens; Medecine Generale Oncologie

location_facility: Centre Catherine de Sienne; Chimiotherapie

location_facility: Cmc De Tronquieres;Chimiotherapie Et Radiotherapie

location_facility: Chi De Cornouaille; Oncologie Hospitalisation

location_facility: Ch Francois Mitterrand; Medecine Oncologie

location_facility: C H Du Pays D'Aix En Provence; Hopital De Jour

location_facility: Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie

location_facility: Groupe Hospitalier Public Du Sud De L'Oise GHPSO; Oncologie

location_facility: Clinique Saint Faron; Sce Oncologie Radiotherapie

location_facility: Centre Mistral; Chirurgie Cancerologie Gynecologiques

location_facility: Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: GH Paris Saint Joseph; Hopital De Jour Oncologie

location_facility: Clinique Armoricaine Radiologie; Cons Externes

location_facility: Centre De Radiotherapie Et D'Oncologie; Oncologie

location_facility: Hopital Clinique Claude Bernard; Oncologie Medicale

location_facility: Ch Georges Renon; Oncologie Radiotherapie

location_facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale

location_facility: Hopital Henri Mondor; Oncologie Medicale

location_facility: Medipole De Savoie; Departement Oncologie

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

location_facility: Ghi Le Raincy Montfermeil; Oncologie Medicale

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie

location_facility: Polyclinique Francheville; Med Chimiotherapie Radiotherapie

location_facility: Clinique Francois 1er; Service De Chimiotherapie

location_facility: Hopitaux Du Leman Site Thonon; Maternite Gynecologie

location_facility: Chi Emile Durkheim Site Epinal; Oncologie

location_facility: Hopital De Falconaja Furiani; Hopital De Jour

location_facility: Ch De Longjumeau; Hopital De Jour Et Semaine

location_facility: Clinique De La Sauvegarde; Chimiotherapie

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: Hopital Antoine Beclere; Hopital De Jour

location_facility: Ctre Hosp Prive Beauregard; Hop De Jour Chimiotherapie

location_facility: CH Annecy Genevois site Annecy; Oncologie

location_facility: Ch Pitie Salpetriere; Oncologie Medicale


title: Medical and Economic Evaluation of an External Beam Radiotherapy Combined With a Brachytherapy Boost Compared With an Exclusive External Beam Radiotherapy for Intermediate-risk Prostate Cancer

summary:
The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment.

The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.

location_facility: Centre d'oncologie et de radiothérapie Mâcon

location_facility: Centre Regional de Lutte Contre Le Cancer Rhone-Alpes Centre Leon Berard

location_facility: Institut de Cancerologie de Lorraine Alexis Vautrin


title: Follow-up of HBsAg Inactive Carriers Study

acronym: PIBAC

summary: The definition of HBs antigen (HBsAg) inactive carrier status has evolved during time. We spoke first from HBsAg" healthy carrier ", then from " asymptomatic carrier ", last from HBsAg" inactive carrier ". This definition continue to be not totally consensual. A very low viral load (< 2000 UI/ml) or undetectable, associated with repetitive normal transaminases and with detectable anti-HBe antibodies were necessary to affirm the inactive carrier status on 2009 EASL recommendations. The 2012 EASL recommendations confirm that the normality of alanine aminotransferase (ALT) with an upper limit of normal (ULN) approximately below 40 UI/ml, like low viral load (HBV-DNA), does necessary be verified every 3 or 4 months during a year to diagnose an inactive carrier. Nevertheless, they admit the possibility for some patients to be inactive carriers with HBV-DNA between 2000 and 20000 UI/ml with consistently normal transaminases This study will follow-up HBsAg inactive carriers during 5 years, in order to evaluate the incidence of unfavourable liver events: chronic hepatits B, liver cirrhosis, hepatocarcinoma (CHC) during this time, and to determine the independant prognosis criteria of unexpected arrival of such events. Secondary outcomes will evaluate HBsAg quantification for the prognosis of such events or, in contrary HBs seroconversion; will evaluate the influence of B genotype on HBsAg level; will evaluate the influence of comorbidities on unexpected arrival of such events.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
Hopital Saint Jean
Medical Center Besancon
Ch de Vannes
Medical Center Nanterre
CH MELUN
CHR d'ORLEANS
Clinique Du Palais
Clinique de La Chataigneraie
Ch D'Hyeres
Ch de Montfermeil
Ch Montelimar
CH CREIL
Hopital Sainte Camille
Ch Sud Fracilien Jean Jaures
Clinical Center Montpellier
Clinical Center Bourgoin Jallieu
Ch de Lagny Marne La Valee
Chd Vendee
Ch de Meaux
Ch de Saint Denis
Ch de Pau
Ch Saint Brieuc
Medical Center La Sauvegarde
CH de GONESSE
Chi Villeneauve Saint Georges
CH d'AVIGNON
Medical Center Paris 7
Ch de Caen
Ch de La Region Annnecienne
Ch Du Mans
Ch de Creteil
Ch General Du Pays D'Aix