title: Validation of a Tool for the Dimensional Assessment of Apathy in a Population Suffering From Schizophrenia.

summary:
Schizophrenia affects about 1% of the world's population. According to the WHO, it was one of the ten most worrying pathologies of the twenty-first century. The situation of psychic disability that results impacted the entire life course. This disease is characterized by positive symptoms (delirium, hallucination, psychotic agitation) and negative symptoms and disorganization (destructuring of thought, language and behavior). Cognitive disorders are easily measurable in the spectrum of schizophrenia and are quantifiable with some tools to measure the level of performance of the individual in different areas.

In these patients apathy is found in one out of two cases (prevalence of 51%), so it is a widespread negative symptom. Apathy corresponds to a pathology of voluntary action that can exist in different forms, resulting from the alteration of one or more mechanisms. It is a predictor of functional outcomes, regardless of positive symptoms or depression.

Studies of people with head injuries have found a link between frontal cognitive impairment and apathy. The recognition, the identification of the dimensional mechanisms of apathy and the understanding of the links with cognitive disorders are therefore a major issue in the improvement of the functional prognosis. Moreover, these mechanisms are currently little studied in the spectrum of schizophrenia.

There are currently questionnaires to show the presence or absence of apathy, such as the Apathy Evaluation Scale or the Lille Apathy Rating Scale. However most scales offer a global apathy score and the proposed treatments are limited due to the difficulty in identifying the dimensions and understanding of the underlying mechanisms of their own.

The potentiality of apathy to become a source of disability is now widely recognized. It is therefore important to consider the expression of this handicap in terms of the repercussions that this disorder may have on the daily lives of patients. There are questionnaires to measure the functional autonomy of patients with a psychic disorder. Apathy is also an obstacle to supporting patients in psychiatry.

The lack of knowledge and underestimation of apathy and its mechanisms in schizophrenia, in addition to overworking the psychiatric health sector, favor a drift towards the institutionalization of the person, with its medico-economic consequences on the system.

lead_sponsor: Centre Hospitalier de Niort

location_facility:
Centre Hospitalier de Niort
Centre Hospitalier Esquirol


title: Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥75 Years)

acronym: capagec

summary: The aim of the study is to determine blood concentration evolution of capecitabine and its active metabolites, in elderly patient 75 years and more.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Daher Abdi Z, Lavau-Denes S, Prémaud A, Urien S, Sauvage FL, Martin J, Leobon S, Marquet P, Tubiana-Mathieu N, Rousseau A. Pharmacokinetics and exposure-effect relationships of capecitabine in elderly patients with breast or colorectal cancer. Cancer Chemother Pharmacol. 2014 Jun;73(6):1285-93. doi: 10.1007/s00280-014-2466-0. Epub 2014 May 7.

family: Daher Abdi

full_name: Z. Daher Abdi

given: Z.

sequence: first

family: Lavau-Denes

full_name: S. Lavau-Denes

given: S.

sequence: additional

family: Prémaud

full_name: A. Prémaud

given: A.

family: Urien

full_name: S. Urien

family: Sauvage

full_name: F. L. Sauvage

given: F. L.

family: Martin

full_name: J. Martin

given: J.

family: Leobon

full_name: S. Leobon

family: Marquet

full_name: P. Marquet

given: P.

family: Tubiana-Mathieu

full_name: N. Tubiana-Mathieu

given: N.

family: Rousseau

full_name: A. Rousseau

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cancer Chemotherapy and Pharmacology

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: publishedVersion

evidence: oa repository (via pmcid lookup)

version: acceptedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Pharmacokinetics and exposure–effect relationships of capecitabine in elderly patients with breast or colorectal cancer

lead_sponsor: University Hospital, Limoges

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: Etude de Recherche de Dose de l'Association Irinotecan (Campto(R)) - Cisplatine (Cisplatyl(R)) Avec la radiothérapie Pelvienne Dans Les Cancers avancés du Col de l'utérus.

summary: Search of maximum tolerated irinotecan dose in association with cisplatin and pelvic radiotherapy in patients with an advanced cervix cancer.

primary_purpose: Treatment

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility:
CRLC Val d'Aurelle
Centre Claudius Régaud

lead_sponsor_type: industriel


title: ARNS 141 TIPI : A Pilot Trial to Assess the Ability of an Intermittent Antiretroviral Therapy in Maintaining an Immunological Stability in Antiretroviral naïve HIV Infected Adults, With CD4 Count Above 500/mm3

acronym: TIPI

summary: The primary objective of the trial is to assess the ability of an early and intermittent antiretroviral therapy in maintaining an immunological stability in antiretroviral naive HIV infected adults, to offer a potential alternative strategy to differed and continuous antiretroviral treatment.This is a 2-year phase II, open-label, multicentric "proof of concept" trial. The patients included are treated following a pulse-therapy scheme, i.e. 6-month periods with once daily boosted-PI based therapy in alternance with 6-month periods without antiretroviral therapy. The preferentially recommended treatment of the study is atazanavir boosted with ritonavir, associated with a fixed combination of abacavir and lamivudine or emtricitabine + tenofovir.The patients are closely followed to assess the efficacy and the tolerance of the strategy, with clinical, biochemical, immunological, virological and pharmacokinetic evaluations.

ReferenceType: derived

ReferenceCitation: Piroth L, Moinot L, Yeni P, Avettand-Fénoel V, Reynes J, Girard PM, Marchou B, Georget A, Rouzioux C, Autran B, Duvillard L, Chêne G, Fagard C; ANRS 141 TIPI Trial Study Group. Immunity, inflammation and reservoir in patients at an early stage of HIV infection on intermittent ART (ANRS 141 TIPI Trial). J Antimicrob Chemother. 2016 Feb;71(2):490-6. doi: 10.1093/jac/dkv369. Epub 2015 Nov 14.

family: Piroth

full_name: Lionel Piroth

given: Lionel

family: Moinot

full_name: Laetitia Moinot

given: Laetitia

family: Yeni

full_name: Patrick Yeni

given: Patrick

family: Avettand-Fénoel

full_name: Véronique Avettand-Fénoel

given: Véronique

family: Reynes

full_name: Jacques Reynes

given: Jacques

family: Girard

full_name: Pierre-Marie Girard

given: Pierre-Marie

family: Marchou

full_name: Bruno Marchou

given: Bruno

family: Georget

full_name: Aurore Georget

given: Aurore

family: Rouzioux

full_name: Christine Rouzioux

given: Christine

family: Autran

full_name: Brigitte Autran

given: Brigitte

family: Duvillard

full_name: Laurence Duvillard

given: Laurence

family: Chêne

full_name: Geneviève Chêne

given: Geneviève

family: Fagard

full_name: Catherine Fagard

given: Catherine

journal_name: Journal of Antimicrobial Chemotherapy

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Services maladies infectieuses et tropicales CHU


title: Six- Versus Twelve-Week Therapy for Non-Surgically-Treated Diabetic Foot Osteomyelitis: A Multicenter Open-Label Controlled Randomized Study

acronym: C H R O N O S

summary: The purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.

design_allocation: Randomized

ReferenceCitation: Tone A, Nguyen S, Devemy F, Topolinski H, Valette M, Cazaubiel M, Fayard A, Beltrand É, Lemaire C, Senneville É. Six-week versus twelve-week antibiotic therapy for nonsurgically treated diabetic foot osteomyelitis: a multicenter open-label controlled randomized study. Diabetes Care. 2015 Feb;38(2):302-7. doi: 10.2337/dc14-1514. Epub 2014 Nov 20. Erratum in: Diabetes Care. 2015 Apr;38(4):735.

family: Tone

full_name: Alina Tone

given: Alina

family: Nguyen

full_name: Sophie Nguyen

given: Sophie

family: Devemy

full_name: Fabrice Devemy

given: Fabrice

family: Topolinski

full_name: Hélène Topolinski

given: Hélène

family: Valette

full_name: Michel Valette

given: Michel

family: Cazaubiel

full_name: Marie Cazaubiel

given: Marie

family: Fayard

full_name: Armelle Fayard

given: Armelle

family: Beltrand

full_name: Éric Beltrand

given: Éric

family: Lemaire

full_name: Christine Lemaire

family: Senneville

full_name: Éric Senneville

journal_name: Diabetes Care

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Six-Week Versus Twelve-Week Antibiotic Therapy for Nonsurgically Treated Diabetic Foot Osteomyelitis: A Multicenter Open-Label Controlled Randomized Study

lead_sponsor: Tourcoing Hospital


type: Other Identifier

title: Multimodal MRI-guided Repetitive Transcranial Magnetic Stimulation to Treat Drug-resistant Hallucinations: a Randomized Control Trial

acronym: MULTIMODHAL

summary:
The efficacy of neuro-navigated rTMS for patients with schizophrenia suffering from drug-resistant multisensory hallucinations will be tested by the implementation of a double-blind randomized controlled trial (RCT)
This study will use a combination of different MRI modalities (fMRI and DTI) to define with precision rTMS brain-targets in the case of multisensory hallucinations
The investigators anticipate that multimodal MRI-guided rTMS will allow a significant improvement in the efficacy of neuromodulation treatment of refractory hallucinations

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Leroy A, Foucher JR, Pins D, Delmaire C, Thomas P, Roser MM, Lefebvre S, Amad A, Fovet T, Jaafari N, Jardri R. fMRI capture of auditory hallucinations: Validation of the two-steps method. Hum Brain Mapp. 2017 Oct;38(10):4966-4979. doi: 10.1002/hbm.23707. Epub 2017 Jun 28.

name: Univ Lille, CNRS, UMR 9193 ‐ SCALab ‐ Sciences Cognitives et Sciences AffectivesLilleF‐59000 France

name: CHU Lille, Psychiatry Dpt., CURE platformLilleF‐59000 France

family: Leroy

full_name: Arnaud Leroy

given: Arnaud

name: Univ Strasbourg, CNRS, UMR 7357 ‐ ICube ‐ Laboratoire des Sciences de l'Ingénieur, de l'Informatique et de l'Imagerie and Fédération de Médecine Translationnelle de Strasbourg (FMTS)StrasbourgF‐67000 France

name: CHU Strasbourg, CEntre de neuroModulation Non Invasive de Strasbourg (CEMNIS)StrasbourgF‐67000 France

family: Foucher

full_name: Jack R. Foucher

given: Jack R.

family: Pins

full_name: Delphine Pins

given: Delphine

name: CHU Lille, Imaging Dpt., Neuroradiology unitLilleF‐59000 France

family: Delmaire

full_name: Christine Delmaire

family: Thomas

full_name: Pierre Thomas

given: Pierre

family: Roser

full_name: Mathilde M. Roser

given: Mathilde M.

family: Lefebvre

full_name: Stéphanie Lefebvre

given: Stéphanie

family: Amad

full_name: Ali Amad

given: Ali

family: Fovet

full_name: Thomas Fovet

given: Thomas

name: Henri Laborit Hospital Centre, Unité de recherche clinique intersectorielle en psychiatrie à vocation régionale Pierre DenikerPoitiersF‐86022 France

name: Univ Poitiers and CHU Poitiers, INSERM, CIC‐P 1402 and U‐1084 Experimental and Clinical Neurosciences LaboratoryPoitiersF‐86022 France

family: Jaafari

full_name: Nemat Jaafari

given: Nemat

family: Jardri

full_name: Renaud Jardri

given: Renaud

journal_name: Human Brain Mapping

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: fMRI capture of auditory hallucinations: Validation of the two‐steps method

ipd_sharing: No

lead_sponsor: University Hospital, Lille

location_facility:
Saint-Anne Psychiatric Hospital
Lille University Hospital Centre

intervention_type: Device

status_simplified: Unknown


type: Registry Identifier

title: Opothérapie Par Hydrocortisone après Injection Unique d'Etomidate Chez le Patient de réanimation

summary: the objective of the study is to assess the value of substitution with 200mg/24h of hydrocortisone for 48 hours for patients in intensive care who have received a single injection of etomidate

ReferenceCitation: Payen JF, Dupuis C, Trouve-Buisson T, Vinclair M, Broux C, Bouzat P, Genty C, Monneret D, Faure P, Chabre O, Bosson JL. Corticosteroid after etomidate in critically ill patients: a randomized controlled trial. Crit Care Med. 2012 Jan;40(1):29-35. doi: 10.1097/CCM.0b013e31822d7938.

family: Payen

full_name: Jean-Francois Payen

given: Jean-Francois

family: Dupuis

full_name: Clément Dupuis

given: Clément

family: Trouve-Buisson

full_name: Thibaut Trouve-Buisson

given: Thibaut

family: Vinclair

full_name: Marc Vinclair

given: Marc

family: Broux

full_name: Christophe Broux

given: Christophe

family: Bouzat

full_name: Pierre Bouzat

family: Genty

full_name: Céline Genty

given: Céline

family: Monneret

full_name: Denis Monneret

given: Denis

family: Faure

full_name: Patrice Faure

given: Patrice

family: Chabre

full_name: Olivier Chabre

given: Olivier

family: Bosson

full_name: Jean-Luc Bosson

given: Jean-Luc

journal_name: Critical Care Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: University Hospital, Grenoble

location_facility: Réanimation polyvalente déchocage, centre hospitalier de la région Annecienne

location_facility: Pôle d'anesthésie - réanimation, University Hospital of Grenoble


title: Double-Blind Randomized Placebo-Controlled Cross-Over Phase IIa Trial to Evaluate Efficacy of CVXL-0107 on Parkinson-Related Symptoms and Levodopa-Induced Dyskinesia in Advanced Parkinson's Disease Patients Using a Levodopa Challenge Test

summary: CVXL-0107 a glutamate release inhibitor, has shown evidence of antiparkinsonian and antidyskinetic activity in a macaque model and has shown a significant effect on the UPDRS-III (Movement Disorder Society - Unified Parkinson's Disease Rating Scale) while "ON", as well as an increase of "ON-time" without dyskinesia or without troublesome dyskinesia in a previous phase 2a proof of concept study. This study will confirm the efficacy of CVXL-0107 in combination with optimal dose of levodopa on motor symptoms of Parkinson's disease (PD) .

lead_sponsor: CleveXel Pharma


title: A First in Human Phase I Study of INVAC-1 as a Single Agent in Patients With Advanced Cancer

summary: INVAC-1 is intended to be used for the treatment of adult patients with advanced solid tumors unresponsive to currently available therapies, or for whom no standard therapy is available.

ReferenceCitation: Teixeira L, Medioni J, Garibal J, Adotevi O, Doucet L, Durey MD, Ghrieb Z, Kiladjian JJ, Brizard M, Laheurte C, Wehbe M, Pliquet E, Escande M, Defrance R, Culine S, Oudard S, Wain-Hobson S, Doppler V, Huet T, Langlade-Demoyen P. A First-in-Human Phase I Study of INVAC-1, an Optimized Human Telomerase DNA Vaccine in Patients with Advanced Solid Tumors. Clin Cancer Res. 2020 Feb 1;26(3):588-597. doi: 10.1158/1078-0432.CCR-19-1614. Epub 2019 Sep 26.

family: Teixeira

full_name: Luis Teixeira

given: Luis

family: Medioni

full_name: Jacques Medioni

given: Jacques

family: Garibal

full_name: Julie Garibal

given: Julie

family: Adotevi

full_name: Olivier Adotevi

family: Doucet

full_name: Ludovic Doucet

given: Ludovic

family: Durey

full_name: Marie-Agnès Dragon Durey

given: Marie-Agnès Dragon

family: Ghrieb

full_name: Zineb Ghrieb

given: Zineb

family: Kiladjian

full_name: Jean-Jacques Kiladjian

given: Jean-Jacques

family: Brizard

full_name: Mara Brizard

given: Mara

family: Laheurte

full_name: Caroline Laheurte

given: Caroline

family: Wehbe

full_name: Maria Wehbe

given: Maria

family: Pliquet

full_name: Elodie Pliquet

given: Elodie

family: Escande

full_name: Marie Escande

given: Marie

family: Defrance

full_name: Rémy Defrance

given: Rémy

family: Culine

full_name: Stephane Culine

given: Stephane

family: Oudard

full_name: Stephane Oudard

family: Wain-Hobson

full_name: Simon Wain-Hobson

given: Simon

family: Doppler

full_name: Valérie Doppler

given: Valérie

family: Huet

full_name: Thierry Huet

given: Thierry

family: Langlade-Demoyen

full_name: Pierre Langlade-Demoyen

given: Pierre

journal_name: Clinical Cancer Research

publisher: American Association for Cancer Research (AACR)

lead_sponsor: Invectys

location_facility:
Hôpital Saint Louis
Hôpital Européen Georges Pompidou

intervention_type: Biological


title: Placebo-controlled Evaluation of Homeopathic Remedy (Cocculine®) Efficacy in the Management of Nausea After Adjuvant Chemotherapy in Non Metastatic Breast Cancer.

summary:
The purpose of the study is to determine whether a homeopathic remedy (Cocculine®) is effective in the prevention of chemotherapy-induced nausea in non metastatic breast cancer.

Eligible patients will be randomly assigned to one of 2-arms: Cocculine® or placebo.

The number of patients required to demonstrate a 0.5-point reduction in nausea on a visual analogue scale, assuming an alpha risk of 5% in a two-sided test and 85% power, is 396 (198 per arm). It has been estimated that the enrollment period should be 18 months.

ReferenceType: background

ReferenceCitation: Pommier P, Gomez F, Sunyach MP, D'Hombres A, Carrie C, Montbarbon X. Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. J Clin Oncol. 2004 Apr 15;22(8):1447-53.

ReferenceCitation: Pérol D, Provençal J, Hardy-Bessard AC, Coeffic D, Jacquin JP, Agostini C, Bachelot T, Guastalla JP, Pivot X, Martin JP, Bajard A, Ray-Coquard I. Can treatment with Cocculine improve the control of chemotherapy-induced emesis in early breast cancer patients? A randomized, multi-centered, double-blind, placebo-controlled Phase III trial. BMC Cancer. 2012 Dec 17;12:603. doi: 10.1186/1471-2407-12-603.

family: Pérol

full_name: David Pérol

given: David

family: Provençal

full_name: Jocelyne Provençal

given: Jocelyne

family: Hardy-Bessard

full_name: Anne-claire Hardy-Bessard

given: Anne-claire

family: Coeffic

full_name: David Coeffic

family: Jacquin

full_name: Jean-Phillipe Jacquin

given: Jean-Phillipe

family: Agostini

full_name: Cécile Agostini

given: Cécile

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Guastalla

full_name: Jean-Paul Guastalla

given: Jean-Paul

family: Pivot

full_name: Xavier Pivot

given: Xavier

family: Martin

full_name: Jean-Pierre Martin

given: Jean-Pierre

family: Bajard

full_name: Agathe Bajard

given: Agathe

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

currency_apc_doaj: GBP

journal_name: BMC Cancer

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

lead_sponsor: Centre Leon Berard


title: Comparison of the Efficacy of Micro-holes vs. Laser-assisted Dermabrasion, for Repigmenting in Vitiligo Skin

acronym: Dermabrasion

summary:
Principal objective: To compare the efficacy of laser-assisted dermabrasion + autologous epidermal cells suspension grafting versus dermabrasion using micro-needling technique + autologous epidermal cells suspension grafting and dermabrasion using micro-needling technique + placebo suspension grafting in stable vitiligo.

A total of 10 patients with stable non-segmental vitiligo will be included in the ITT population.

In each patient, three separate test areas will be selected in the same part of the body.

One area will be pre-treated with dermaroller and receive the hyaluronic acid suspension alone and the two others will receive the epidermal cell suspension in hyaluronic acid after pre-treatment either with dermaroller or laser-assisted dermabrasion, each patient being his own control.

Targeted phototherapy with excimer lamp (308 nMm) will be applied on all test areas 1 week after cell grafting.

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CH Creteil
CHU de Bordeaux
CHU de Nice


title: Efficiency of Ursodesoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis Patients. URSOPAF

summary: Malignant transformation of adenomas of the duodenum is now the leading cause of death in familial adenomatous polyposis (FAP) patients who had a restorative proctocolectomy. Ursodeoxycholic acid (UDCA) modifies the biliary acid profile and could reduce the severity of duodenal adenomas and prevent such transformation.

ReferenceCitation: Spigelman AD, Williams CB, Talbot IC, Domizio P, Phillips RK. Upper gastrointestinal cancer in patients with familial adenomatous polyposis. Lancet. 1989 Sep 30;2(8666):783-5.

ReferenceCitation: Nugent KP, Farmer KC, Spigelman AD, Williams CB, Phillips RK. Randomized controlled trial of the effect of sulindac on duodenal and rectal polyposis and cell proliferation in patients with familial adenomatous polyposis. Br J Surg. 1993 Dec;80(12):1618-9.

ReferenceCitation: Järvinen HJ, Nyberg M, Peltokallio P. Biliary involvement in familial adenomatosis coli. Dis Colon Rectum. 1983 Aug;26(8):525-8.

ReferenceCitation: Spigelman AD, Owen RW, Hill MJ, Phillips RK. Biliary bile acid profiles in familial adenomatous polyposis. Br J Surg. 1991 Mar;78(3):321-5.

ReferenceCitation: Mower HF, Ray RM, Shoff R, Stemmermann GN, Nomura A, Glober GA, Kamiyama S, Shimada A, Yamakawa H. Fecal bile acids in two Japanese populations with different colon cancer risks. Cancer Res. 1979 Feb;39(2 Pt 1):328-31.

ReferenceCitation: Hill MJ, Drasar BS, Williams RE, Meade TW, Cox AG, Simpson JE, Morson BC. Faecal bile-acids and clostridia in patients with cancer of the large bowel. Lancet. 1975 Mar 8;1(7906):535-9.

ReferenceCitation: Tanida N, Hikasa Y, Shimoyama T, Setchell KD. Comparison of faecal bile acid profiles between patients with adenomatous polyps of the large bowel and healthy subjects in Japan. Gut. 1984 Aug;25(8):824-32.

ReferenceCitation: van der Werf SD, Nagengast FM, van Berge Henegouwen GP, Huijbregts AW, van Tongeren JH. Colonic absorption of secondary bile-acids in patients with adenomatous polyps and in matched controls. Lancet. 1982 Apr 3;1(8275):759-62.

ReferenceCitation: Wilpart M, Mainguet P, Maskens A, Roberfroid M. Structure-activity relationship amongst biliary acids showing comutagenic activity towards 1,2-dimethylhydrazine. Carcinogenesis. 1983 Oct;4(10):1239-41.

ReferenceCitation: Earnest DL, Holubec H, Wali RK, Jolley CS, Bissonette M, Bhattacharyya AK, Roy H, Khare S, Brasitus TA. Chemoprevention of azoxymethane-induced colonic carcinogenesis by supplemental dietary ursodeoxycholic acid. Cancer Res. 1994 Oct 1;54(19):5071-4.

ReferenceCitation: Serfaty L, De Leusse A, Rosmorduc O, Desaint B, Flejou JF, Chazouilleres O, Poupon RE, Poupon R. Ursodeoxycholic acid therapy and the risk of colorectal adenoma in patients with primary biliary cirrhosis: an observational study. Hepatology. 2003 Jul;38(1):203-9.

ReferenceCitation: Parc Y, Piquard A, Dozois RR, Parc R, Tiret E. Long-term outcome of familial adenomatous polyposis patients after restorative coloproctectomy. Ann Surg. 2004 Mar;239(3):378-82.

ReferenceCitation: Parc Y, Desaint B, Fléjou JF, Lefèvre JH, Serfaty L, Vienne A, Kotti S, Simon T, Tiret E. The effect of ursodesoxycholic acid on duodenal adenomas in familial adenomatous polyposis: a prospective randomized placebo-control trial. Colorectal Dis. 2012 Jul;14(7):854-60. doi: 10.1111/j.1463-1318.2011.02816.x.

family: Parc

full_name: Y. Parc

given: Y.

family: Desaint

full_name: B. Desaint

given: B.

family: Fléjou

full_name: J.-F. Fléjou

family: Lefèvre

full_name: J. H. Lefèvre

given: J. H.

family: Serfaty

full_name: L. Serfaty

given: L.

family: Vienne

full_name: A. Vienne

given: A.

family: Kotti

full_name: S. Kotti

given: S.

family: Simon

full_name: T. Simon

given: T.

family: Tiret

full_name: E. Tiret

given: E.

journal_name: Colorectal Disease

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Comparison of the Analgesic Effect of a New Paracetamol Formulation (Paracetamol UNIFLASH) for Buccal Use and Two Different Doses of an Oral Paracetamol Form Controlled Versus Placebo in Patients Suffering From Moderate Pain Due to a Tooth Extraction.

summary: This study aims to evaluate the analgesic efficacy of single dose of a new paracetamol formulation (paracetamol UNIFLASH) for buccal use in comparison to two different doses of an oral paracetamol form controlled versus placebo.

status: Recruiting

ipd_sharing_description: At this stage, IPD sharing plan has to been discussed and finalised

lead_sponsor: Unither Pharmaceuticals, France

location_country: Spain France Poland

location_facility: Centro Médico Teknon - Grupo Quironsalud

location_facility: Oral Surgery Department, Central Clinical Hospital

location_facility: NZOZ Akademicka Poliklinika Stomatologiczna

location_facility: Hospitalario Universitario de Santiago (CHUS)

location_facility: Faculty of Medicine of the UNIVERSITY OF MURCIA

location_facility: Oral surgery Medical University of Lublin

status_simplified: Ongoing


title: A Comparative, Randomized, Double-blind, 3-arm Parallel, Phase III Study to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Nefopam/Paracetamol Taken Orally in Moderate to Severe Pain After Impacted Third Molar Extraction

summary: This study aims to evaluate the analgesic efficacy of single and multiple doses of a new fixed dose combination of nefopam hydrochloride 30 mg and paracetamol 500mg taken orally in comparison to each single component.

location_country:
United Kingdom
Russian Federation
France

location_facility: LLC Center for interdisciplinary dentistry & neuro

location_facility: BARTS HEALTH NHS TRUST Royal London Hospital

intervention_type: Combination Product


title: Construction of a Composite Clinical-echo Score Predictive of a Risk of Short-term Aggravation of Respiratory Impairment in Patients Suspected of Covid-19

acronym: VIRUS

summary:
With the influx of patients suspected of Covid-19 and the limited number of hospital beds, there is a need for sensitive triage to detect patients at risk of pulmonary complications and therefore requiring hospitalization, but also specific triage to safely discharge patients without risk factors or signs of clinical or ultrasound severity. The use of pulmonary ultrasound in addition to clinical assessment seems appropriate. Indeed, it allows early detection of signs of pneumopathy which, in the current context, most often correspond to Covid-19. These signs include B-lines, which indicate interstitial pulmonary oedema, and an anfractuous and thickened pleural line, or even centimetric parenchymal condensations with a low level of pleural effusion. Conversely, the presence of a medium to large pleural effusion is not very suggestive of the diagnosis of Covid-19. In addition, a lung ultrasound score has been developed and validated to assess the severity of acute respiratory distress and predict the occurrence of acute respiratory distress syndrome. It is based on the performance of a 12-point (6 per hemi-thorax) pulmonary ultrasound with the collection of the presence of B-lines, condensation or pleural effusion. In the hands of a trained operator, this examination takes only a few minutes.

The aim of the study is to develop a score based on clinical and ultrasound evidence to allow early and safer referral than that based on clinical evidence alone. To do this, the study will retrospectively collect clinical and lung ultrasound data from departments that use this technique on a daily basis.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Nantes University Hospital

intervention_type: Other


title: Use of Selincro and Impact on Usual Practice

acronym: USE-PACT

summary: USE-PACT is a cohort study of patients initiating Selincro® with one-year follow-up, performed using a random sample of prescribers. The aim of the study is to evaluate the use of Selincro in real-life and its impact on alcohol consumption at one year.

time_perspective: Prospective

lead_sponsor: University of Bordeaux


title: A Phase I - II Study to Assess Safety and Efficacy of the Combination of Ponatinib With High or Intermediate-Dose Cytarabine as Consolidation Therapy for Patients With Intermediate-Risk Cytogenetic FLT3-ITD AML iIn First Complete Remission

acronym: PONATINIB-AML

summary:
This project is part of a joint ALFA and GOELAM strategy aiming to improve the survival of patients with newly diagnosed Acute Myeloid Leukemia (AML) aged 18-70 years. The basis of this strategy is to evaluate intensified conventional chemotherapy and targeted drugs in selected disease-risk subgroups of adult patients with non promyelocytic AML. Participation will be proposed to almost all adult patients in France aged 18-70 years and diagnosed with AML.

FLT3 genetic alterations include FLT3 somatic point mutations within the second tyrosine kinase domain and internal duplications of the juxta-membrane domain. This alteration is refered to as FLT3-ITD. The FLT3-ITD mutation is found in around 30% of patients with cytogenetically normal AML. Patients with the FLT3-ITD genotype have been reported to have a poor outcome when treated with conventional chemotherapy with an estimated 4-year relapse-free survival of 25% (Schlenk et al. N Engl J Med 2008). More recently, the prognostic relevance of FLT3-ITD has been studied in the context of integrated genetic profiling. This confirmed the genetic complexity of AML and also that FLT3-ITD was associated with reduced overall survival in intermediate-risk AML. A multivariate analysis of several genetic alterations revealed that FLT3-ITD was the primary predictor of patient outcome. FLT3-ITD mutations were classified in 3 categories: 1) FLT3-ITD with +8, TET2, DNMT3A or MLL-PTD mutations (3-year OS 14.5%); 2) FLT3-ITD with wild type CEBPA, TET2, DNMT3 and MLL-PTD (3-year OS 35.2%) and 3) FLT3-ITD with CEBPA mutations (3-year OS 42%) (Patel JP et al. N Engl J Med 2012). However, FLT3-ITD was not a predictor of response to induction therapy, allowing the introduction of targeted therapies after the induction course.

Several FLT3 inhibitors have been evaluated or are currently being tested in the setting of relapsing AML. In most trials to date, patients were only eligible if the FLT3-ITD mutation was present. Disappointing results were reported with the first generation of FLT3 inhibitors, including lestaurtinib (CEP-701), midostaurin (PKC-412) and sorafenib. Second generation FLT3 inhibitors such as quizartinib (AC220) are currently under investigation with promising results. However, the hematologic toxicity of AC220 will likely present a major limitation in evaluating AC220 combined with standard or high-dose chemotherapy.

Ponatinib (AP24534) is a third generation tyrosine kinase inhibitor targeting the BCR-ABL tyrosine kinase domain. Ponatinib was rationally designed with an extensive network of optimized molecular contacts and triple bonds to accommodate the T315I mutation, a major cause of resistance to tyrosine kinase inhibitors in chronic and advanced phase chronic myelogenous leukemia (CML). Ponatinib also inhibits SRC (IC50: 5.4 nM) and members of the VEGFR, FGFR, and PDGFR families of receptor tyrosine kinases (O'Hare T, Cancer Cell 2009). Despite low activity against FLT3 based on the IC50 value (FLT3 IC50: 12.6 nM compared to BCR IC50: 0.37 nM), ponatinib has recently been reported to have significant cellular activity against the MV4-11 cell line which harbors an FLT3-ITD activating mutation. Ponatinib-induced apoptosis was maximal at 10 nM in vitro and a single dose of 5 and 10 mg/kg had a strong inhibitory effect in vivo in mice bearing MV4-11 xenografts. Primary blast cells from 4 FLT3-ITD AML patients were also tested and ponatinib reduced their viability (IC50: 4 nM) whereas no activity was shown on FLT3-ITD-negative blast cells (Gozgit JM et al. Mol Cancer Ther 2011).

Preliminary data from the phase I clinical trial showed that 15 mg ponatinib was associated with a Cmax of 51.1 nM. Cmax was increased to 111 nM and 149 nM in the 30 mg and 45 mg cohorts respectively. The trough concentrations were 55.3 nM and 61.9 nM for the 30 mg and 45 mg doses respectively (Ariad clinical investigator's brochure, version 3). Results from the ongoing phase II trial in CML patients suggest that the hematological toxicity profile of ponatinib is comparable with that of nilotinib or dasatinib, both of which have been successfully combined with conventional chemotherapy.

Investigators thus aim to combine ponatinib with cytarabine in FLT3-ITD AML patients in first complete remission.

status: Active, not recruiting

lead_sponsor: Versailles Hospital

location_facility:
Hôpital Edouard Herriot
Hôpital Henri Mondor
CHRU Dupuytren
Dr Stéphanie HAÏAT
CHU d'Angers
Hôpital Necker Enfants Malades
Dr Jacques DELAUNAY
CHU Nice, Hôpital Archet 1
Hôpital d'Instruction des Armées PERCY
CHU de Besançon
Dr Abdelaziz CHAIB
Hôpital Saint Antoine
Hôpital Claude Huriez
Centre Hospitalier René Huguenin
Chr Clemenceau
Centre hospitalier de Versailles
Dr Christian RECHER
Dr Mario OJEDA-URIBE
Dr Edouard RANDIAMALALA
CHU de Nîmes
Centre Hospitalier René Dubos
Centre Hospitalier de Valenciennes
CHU de Dijon
Marc BERNARD
Dr Laurence SANHES
Dr Regis COSTELLO
Dr Thorsten BRAUN
Institut de Cancérologie de la Loire
Dr Arnaud PIGNEUX
Centre Hospitalier de Meaux
Hôpital Saint Louis
Hôpital VICTOR DUPOUY
Chu Amiens
Dr Réda GARIDI
Hôpital La Pitié Salpêtrière
Dr Emilie LEMASLE
CHU Boulogne Sur Mer


title: Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damage Subjects 2 (CORAC2)

summary:
Two groups of subjects will be constitute: (i) patients with circumscribed brain injury (including stroke, vascular malformations, tumor or circumscribed infectious lesions) or degenerative/developmental disorders and selective cognitive disorders; (ii) healthy control subjects.

The objective of this project is to evaluate specific neuropsychological deficits and apply current brain imaging techniques (anatomical, diffusion, functional, magnetic stimulation) to patients suffering from these cognitive deficits due to brain damage, in order to elucidate the brain mechanisms underlying these deficits.

lead_sponsor: University Hospital, Caen


title: Are Bone, Nutritional and Cardiovascular Status of French Children and Adolescents, Correlated With Their Vitamin D Status?

acronym: VITADOS

summary:
Vitamin D is not seen anymore only as a phosphocalcic hormone, but also as having an effect on global health (anti-infective, anti-inflammatory, anti-tumour roles and cardiovascular protection).

The link between vitamin D deficiency and osteomalacia lesions is well-known. In paediatrics, systematic vitamin D supplementation of infants and toddlers, associated with milk enrichment, has allowed an almost total disappearance of rickets. Vitamin D repletion was defined as the minimal concentration that enables the prevention of rickets in children and osteomalacia in adults, that is approximately 8 ng/mL (20 nmol/L). However, in 2010, most of the international experts agreed to set minimal threshold of 25 OH vitamin D serum concentration, higher than the one previously admitted, with a limit of 20 ng/mL (50 nmol/L) to define a vitamin D deficiency and a limit of 30 ng/mL (75 nmol/L) to define vitamin D insufficiency in adults. In the paediatric population, the consensus is less obvious and we consider that a serum concentration of minimum 20 ng/mL is necessary.

A study on more than 200 children from Lyon, followed in the paediatric nephrology unit and having a renal function normal or sub-normal, demonstrated an important prevalence of vitamin D deficiency (75%) in adolescents and pre-adolescents.

Concurrently, the appearance of new bone imaging techniques (especially high-resolution peripheral quantitative computed tomography HR-pQCT) improved bone status evaluation in a non-invasive manner.

Given the new pathophysiological data on pleiotropic role of vitamin D (bone, cardiovascular system, adipose tissue) and given the proportion of French children possibly suffering from vitamin D deficiency, it seems urgent to actualize current recommendations regarding systematic supplementation in vitamin D. This transversal study on 200 healthy children and adolescents will allow to have an overview of vitamin D status in French healthy children and adolescents, studying with non-invasive, safe, reliable and innovative tools, the theoretical targets of vitamin D (bones, cardiovascular system and nutritional status); and then to lay the foundations of therapeutic trials aiming to evaluate the mode of vitamin D supplementation for healthy children and adolescents; while having a cohort for HR-pQCT measurements, that will allow us to have French reference range in a 10-17 year-old population, for this innovative, non-invasive and low radiation exposure technique.

primary_purpose: Health Services Research

lead_sponsor: Hospices Civils de Lyon


title: Prospective Cohort Study on Patients With Tedizolid Prolonged Therapy for Orthopedic Device Infections

acronym: TEDIZOAM

summary: Pilot study the aim of which is to obtain reliable data on the tolerance, compliance and efficacy of Tedizolid used as prolonged (≥ 6 weeks) monotherapy or in combination therapy for the treatment of patients with orthopedic device infections due to Gram positive cocci.

ReferenceCitation: Titécat M, Senneville E, Wallet F, Dezèque H, Migaud H, Courcol RJ, Loïez C. Microbiologic profile of Staphylococci isolated from osteoarticular infections: evolution over ten years. Surg Infect (Larchmt). 2015 Feb;16(1):77-83. doi: 10.1089/sur.2013.258. Epub 2015 Feb 4.

name: Institute of Microbiology, University Hospital Center, Lille, France.

family: Titécat

full_name: Marie Titécat

given: Marie

name: Infectious Diseases Department, Dron Hospital, Tourcoing, France.

name: Centre de Référence des Infections Ostéo-Articulaires Complexes Nord-Ouest (CRIOAC-NO), Lille, Tourcoing, France.

name: University of Lille Nord de France, Lille, France.

family: Senneville

full_name: Eric Senneville

given: Eric

family: Wallet

full_name: Frédéric Wallet

given: Frédéric

name: Department of Orthopedic Surgery, University Hospital Center, Lille, France.

family: Dezèque

full_name: Hervé Dezèque

given: Hervé

family: Migaud

full_name: Henri Migaud

given: Henri

family: Courcol

full_name: René J. Courcol

given: René J.

family: Loïez

full_name: Caroline Loïez

given: Caroline

journal_name: Surgical Infections

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

title: Microbiologic Profile of Staphylococci Isolated from Osteoarticular Infections: Evolution over Ten Years

ReferenceCitation: Titécat M, Senneville E, Wallet F, Dezèque H, Migaud H, Courcol RJ, Loïez C. Bacterial epidemiology of osteoarticular infections in a referent center: 10-year study. Orthop Traumatol Surg Res. 2013 Oct;99(6):653-8. doi: 10.1016/j.otsr.2013.02.011. Epub 2013 Aug 27.

full_name: M. Titécat

given: M.

full_name: E. Senneville

full_name: F. Wallet

given: F.

full_name: H. Dezèque

given: H.

full_name: H. Migaud

full_name: R.-J. Courcol

full_name: C. Loïez

given: C.

journal_name: Orthopaedics & Traumatology: Surgery & Research

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Pulcini C, Couadau T, Bernard E, Lorthat-Jacob A, Bauer T, Cua E, Mondain V, Chichmanian RM, Dellamonica P, Roger PM. Adverse effects of parenteral antimicrobial therapy for chronic bone infections. Eur J Clin Microbiol Infect Dis. 2008 Dec;27(12):1227-32. doi: 10.1007/s10096-008-0570-y. Epub 2008 Sep 26.

family: Pulcini

full_name: C. Pulcini

family: Couadau

full_name: T. Couadau

family: Bernard

full_name: E. Bernard

journal_name: European Journal of Clinical Microbiology & Infectious Diseases

ReferenceCitation: Spellberg B, Lipsky BA. Systemic antibiotic therapy for chronic osteomyelitis in adults. Clin Infect Dis. 2012 Feb 1;54(3):393-407. doi: 10.1093/cid/cir842. Epub 2011 Dec 12. Review.

title: Systemic Antibiotic Therapy for Chronic Osteomyelitis in Adults

ReferenceCitation: Morata L, Tornero E, Martínez-Pastor JC, García-Ramiro S, Mensa J, Soriano A. Clinical experience with linezolid for the treatment of orthopaedic implant infections. J Antimicrob Chemother. 2014 Sep;69 Suppl 1:i47-52. doi: 10.1093/jac/dku252. Review.

ReferenceCitation: Morata L, Senneville E, Bernard L, Nguyen S, Buzelé R, Druon J, Tornero E, Mensa J, Soriano A. A Retrospective Review of the Clinical Experience of Linezolid with or Without Rifampicin in Prosthetic Joint Infections Treated with Debridement and Implant Retention. Infect Dis Ther. 2014 Dec;3(2):235-43. doi: 10.1007/s40121-014-0032-z. Epub 2014 Aug 20.

ReferenceCitation: Senneville E, Legout L, Valette M, Yazdanpanah Y, Beltrand E, Caillaux M, Migaud H, Mouton Y. Effectiveness and tolerability of prolonged linezolid treatment for chronic osteomyelitis: a retrospective study. Clin Ther. 2006 Aug;28(8):1155-1163. doi: 10.1016/j.clinthera.2006.08.001.

title: Effectiveness and tolerability of prolonged linezolid treatment for chronic osteomyelitis: A retrospective study

ReferenceCitation: Senneville E, Legout L, Valette M, Yazdanpanah Y, Giraud F, Beltrand E, Obert G, Dubreuil L, Migaud H, Mouton Y. Risk factors for anaemia in patients on prolonged linezolid therapy for chronic osteomyelitis: a case-control study. J Antimicrob Chemother. 2004 Oct;54(4):798-802. Epub 2004 Aug 25.

ReferenceCitation: Legout L, Senneville E, Gomel JJ, Yazdanpanah Y, Mouton Y. Linezolid-induced neuropathy. Clin Infect Dis. 2004 Mar 1;38(5):767-8.

ReferenceCitation: Legout L, Valette M, Dezeque H, Nguyen S, Lemaire X, Loïez C, Caillaux M, Beltrand E, Dubreuil L, Yazdanpanah Y, Migaud H, Senneville E. Tolerability of prolonged linezolid therapy in bone and joint infection: protective effect of rifampicin on the occurrence of anaemia? J Antimicrob Chemother. 2010 Oct;65(10):2224-30. doi: 10.1093/jac/dkq281. Epub 2010 Jul 29.

ReferenceCitation: Betriu C, Morales G, Rodríguez-Avial I, Culebras E, Gómez M, López-Fabal F, Picazo JJ. Comparative activities of TR-700 (torezolid) against staphylococcal blood isolates collected in Spain. Antimicrob Agents Chemother. 2010 May;54(5):2212-5. doi: 10.1128/AAC.01653-09. Epub 2010 Feb 22.

name: Servicio de Microbiología Clínica, Hospital Clínico San Carlos, Madrid, Spain

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

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

title: Comparative Activities of TR-700 (Torezolid) against Staphylococcal Blood Isolates Collected in Spain

ReferenceCitation: Douros A, Grabowski K, Stahlmann R. Drug-drug interactions and safety of linezolid, tedizolid, and other oxazolidinones. Expert Opin Drug Metab Toxicol. 2015;11(12):1849-59. doi: 10.1517/17425255.2015.1098617. Epub 2015 Oct 12. Review. Erratum in: Expert Opin Drug Metab Toxicol. 2015;11(12):v.

journal_name: Expert Opinion on Drug Metabolism & Toxicology

title: Drug–drug interactions and safety of linezolid, tedizolid, and other oxazolidinones

ReferenceCitation: Flanagan SD, Bien PA, Muñoz KA, Minassian SL, Prokocimer PG. Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Pharmacotherapy. 2014 Mar;34(3):240-50. doi: 10.1002/phar.1337. Epub 2013 Aug 7.

name: Minassian Biostatistics San Diego California

journal_name: Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy

title: Pharmacokinetics of Tedizolid Following Oral Administration: Single and Multiple Dose, Effect of Food, and Comparison of Two Solid Forms of the Prodrug

ReferenceCitation: Flanagan S, McKee EE, Das D, Tulkens PM, Hosako H, Fiedler-Kelly J, Passarell J, Radovsky A, Prokocimer P. Nonclinical and pharmacokinetic assessments to evaluate the potential of tedizolid and linezolid to affect mitochondrial function. Antimicrob Agents Chemother. 2015 Jan;59(1):178-85. doi: 10.1128/AAC.03684-14. Epub 2014 Oct 20.

name: Cubist Pharmaceuticals, San Diego, California, USA

name: College of Medicine, Central Michigan University, Mount Pleasant, Michigan, USA

name: Louvain Drug Research Institute, Université Catholique de Louvain, Brussels, Belgium

name: Cognigen Corporation, Buffalo, New York, USA

title: Nonclinical and Pharmacokinetic Assessments To Evaluate the Potential of Tedizolid and Linezolid To Affect Mitochondrial Function

ReferenceCitation: Lodise TP, Bidell MR, Flanagan SD, Zasowski EJ, Minassian SL, Prokocimer P. Characterization of the haematological profile of 21 days of tedizolid in healthy subjects. J Antimicrob Chemother. 2016 Sep;71(9):2553-8. doi: 10.1093/jac/dkw206. Epub 2016 Jun 17.

ReferenceCitation: Schmidt-Malan SM, Greenwood Quaintance KE, Karau MJ, Patel R. In vitro activity of tedizolid against staphylococci isolated from prosthetic joint infections. Diagn Microbiol Infect Dis. 2016 May;85(1):77-9. doi: 10.1016/j.diagmicrobio.2016.01.008. Epub 2016 Jan 12.

journal_name: Diagnostic Microbiology and Infectious Disease

ReferenceCitation: Morata L, Mensa J, Soriano A. New antibiotics against gram-positives: present and future indications. Curr Opin Pharmacol. 2015 Oct;24:45-51. doi: 10.1016/j.coph.2015.07.004. Epub 2015 Jul 30. Review. Erratum in: Curr Opin Pharmacol. 2015 Oct;24:147.

location_facility:
Hôpital Ambroise Paré
Hôpital de la Croix Rousse


title: Pilot Study on Interferon Gamma in Association With Peg-Interferon Alpha 2a and Ribavirin Among Patients With a Chronic Hepatitis C and Non Responders to the Association of Peg-Interferon Alpha 2b or 2a and Ribavirin ANRS HC16 Gammatri

summary: Viral hepatitis C is treated with peg-interferon alpha 2a/2b and ribavirin. There is no treatment recommended for non responders patients. This study will evaluate the efficacy, after a second treatment with peg-interferon alpha 2a and ribavirin for 12 Weeks of the addition of interferon gamma in non responders patients

ReferenceCitation: Couzigou P, Pérusat S, Bourlière M, Trimoulet P, Poynard T, Leroy V, Marcellin P, Foucher J, Bronowicki JP, Chêne G; ANRS HC16 GAMMATRI Trial Group. Interferon-gamma with peginterferon alpha-2a and ribavirin in nonresponder patients with chronic hepatitis C (ANRS HC16 GAMMATRI). J Gastroenterol Hepatol. 2013 Feb;28(2):329-34. doi: 10.1111/jgh.12060.

family: Couzigou

full_name: Patrice Couzigou

given: Patrice

name: INSERM U897; ISPED; Université Victor Ségalen, Bordeaux 2; Bordeaux France

family: Pérusat

full_name: Sophie Pérusat

given: Sophie

name: AP-HM; St Joseph Hospital; Marseille France

family: Bourlière

full_name: Marc Bourlière

given: Marc

family: Trimoulet

full_name: Pascale Trimoulet

given: Pascale

name: AP-HP; Pitié-Salpétrière Hospital; Paris France

family: Poynard

full_name: Thierry Poynard

given: Thierry

name: CHU de Grenoble; Albert Michallon Hospital; Grenoble France

family: Leroy

full_name: Vincent Leroy

given: Vincent

family: Marcellin

full_name: Patrick Marcellin

given: Patrick

family: Foucher

full_name: Juliette Foucher

given: Juliette

name: CHU de Nancy; Brabois Hospital; Nancy France

family: Bronowicki

full_name: Jean-Pierre Bronowicki

given: Jean-Pierre

family: Chêne

full_name: Geneviève Chêne

given: Geneviève

journal_name: Journal of Gastroenterology and Hepatology

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

location_facility: Hopital Haut Leveque Service d'Hepato-Gastro-Enterologie


lead_sponsor: University Hospital, Montpellier

acronym: BenraliScan

location_facility: Assistance Publique - Hopitaux de Marseille

type: EudraCT Number

source: euctr

title: Computed Tomography Air-trapping Characterisation for the Early Identification of Benralizumab Responders Among Eosinophilic Asthma Patients

summary:
BenraliScan aims to obtain thoracic computed tomography imaging data to predict the future level of patient response to a monoclonal antibody. Because the clinical responses under study can take many months to manifest, early identification of patients most-likely to benefit from treatment and treatment rule-out for others will save considerable time for everybody involved.

The primary objective of BenraliScan is to determine the prognostic value (sensitivity, specificity, positive predictive value, negative predictive value) of air-trapping measures (Expiratory/Inspiratory ratios for Mean Lung Density (MLDe/i)) detected via quantitative thoracic computed tomography at baseline for improvement in exacerbation rate (the presence of a ≥50% reduction in baseline exacerbation rate versus the absence of a ≥50% reduction in baseline exacerbation rate) at 52 weeks among eosinophilic asthma patients treated with Benralizumab.


title: Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm

acronym: LEVEA

summary: The purpose of the LEVEA study is to assess the performances of a new automatic left ventricular auto threshold (LVAT) algorithm (In-Clinic LVAT algorithm) when used by physicians during in-hospital follow-up.

lead_sponsor: LivaNova


title: Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment . Geriatric Oncology Protocol in Aquitaine Country.

acronym: ONCOGERIATRIE

summary: Number of elderly people over 70 is increasing in France. In 2002, in the south-west, 273,741 of them were over 75 years, i.e. 9.2% of Aquitaine population. Incidence of cancer in this old age is 16,500 new cases per year, more than fifty percent of people with cancer. Treatment modalities of elderly people is one of the 70 priorities of the "Plan cancer" instituted by the French government. They are very few therapeutic trials dedicated. Oncologists hesitate to treat them because they are either afraid of inducing toxicity or of breaking down quality of life. Consequently, we decided to launch a protocol with both oncologists and geriatricians which principal aim is to find out if geriatric assessment data can help to better predict for chemotherapy toxicity, loss of autonomy and survival. We plan to accrue 360 patients diagnosed for cancer, including digestive, pulmonary, prostate, lymphoma, bladder, ovary cancer for whom first-line chemotherapy is planned. Patients are initially classified according to usual methods of medical oncology practice into three groups: patients who can receive standard treatment, reduced standard treatment or treatment adapted to the frail condition. Around Aquitaine, , we organised seven teams composed of one geriatrician and one nurse. Two kind of teams were activated: one which cover ten treatment sites in Bordeaux area and six sedentary teams which worked half a day a week in designated hospitals . Geriatric evaluation included test of cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL;IADL), quality of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening. Patients have four geriatric evaluations : before treatment, day 1 cycle 2, day 1 cycle 4, day 1 cycle 7 and/or end of chemotherapy. Since September 2002, 177 patients have been included, 112 have finished: 47.3% have received four evaluations, 16.1% died before the end of protocol, 14.3% stopped because they were in progression and changed their treatment, 11.6% met administrative problem that didn't allow all evaluations, 7.1% declined after inclusion and 3.6% finished their treatment before. The following results have been obtained: before treatment, 73% of these patients were at risk of undernutrition (MNA< 23.5), about 1/3 had one or more inability or a risk of falls (38% IADL<6, 29% get up and go>20seconds, 27% ADL>1, 34% PS<1), 28% of them had altered cognitive functions (MMS<24), 29% were depressive (GDS-15>6), 25% thought they had poor quality of life (QLQ-C30<4). Protocol will be closed in September 2005.

ReferenceCitation: Hoppe S, Rainfray M, Fonck M, Hoppenreys L, Blanc JF, Ceccaldi J, Mertens C, Blanc-Bisson C, Imbert Y, Cany L, Vogt L, Dauba J, Houédé N, Bellera CA, Floquet A, Fabry MN, Ravaud A, Chakiba C, Mathoulin-Pélissier S, Soubeyran P. Functional decline in older patients with cancer receiving first-line chemotherapy. J Clin Oncol. 2013 Nov 1;31(31):3877-82. doi: 10.1200/JCO.2012.47.7430. Epub 2013 Sep 23.

name: Stéphanie Hoppe, Marianne Fonck, Laurent Hoppenreys, Cécile Mertens, Nadine Houédé, Carine A. Bellera, Anne Floquet, Marie-Noëlle Fabry, Camille Chakiba, Simone Mathoulin-Pélissier, and Pierre Soubeyran, Institut Bergonié; Muriel Rainfray, Jean-Frédéric Blanc, Cécile Mertens, and Alain Ravaud, Centre Hospitalier Universitaire; Muriel Rainfray, Christèle Blanc-Bisson, Alain Ravaud, Simone Mathoulin-Pélissier, and Pierre Soubeyran, University of Bordeaux, Bordeaux; Joël Ceccaldi, Centre Hospitalier,...

family: Hoppe

full_name: Stéphanie Hoppe

given: Stéphanie

family: Rainfray

full_name: Muriel Rainfray

given: Muriel

family: Fonck

full_name: Marianne Fonck

given: Marianne

family: Hoppenreys

full_name: Laurent Hoppenreys

given: Laurent

family: Blanc

full_name: Jean-Frédéric Blanc

given: Jean-Frédéric

family: Ceccaldi

full_name: Joël Ceccaldi

given: Joël

family: Mertens

full_name: Cécile Mertens

given: Cécile

family: Blanc-Bisson

full_name: Christèle Blanc-Bisson

given: Christèle

family: Imbert

full_name: Yves Imbert

given: Yves

family: Cany

full_name: Laurent Cany

family: Vogt

full_name: Luc Vogt

given: Luc

family: Dauba

full_name: Jérôme Dauba

given: Jérôme

family: Houédé

full_name: Nadine Houédé

given: Nadine

family: Bellera

full_name: Carine A. Bellera

given: Carine A.

family: Floquet

full_name: Anne Floquet

given: Anne

family: Fabry

full_name: Marie-Noëlle Fabry

given: Marie-Noëlle

family: Ravaud

full_name: Alain Ravaud

given: Alain

family: Chakiba

full_name: Camille Chakiba

given: Camille

family: Mathoulin-Pélissier

full_name: Simone Mathoulin-Pélissier

given: Simone

family: Soubeyran

full_name: Pierre Soubeyran

given: Pierre

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Functional Decline in Older Patients With Cancer Receiving First-Line Chemotherapy

lead_sponsor: Institut Bergonié

location_facility: Centre Hospitalier Universitaire de Perigueux

location_facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Universitaire de Mont de Marsan

location_facility: Centre Hospitalier Universitaire de Villeneuve sur Lot

location_facility: Centre Hospitalier Universitaire de Bayonne


title: Impact of the COVID-19 Pandemic on the Quality of Psychological Life of Healthcare Professionals

acronym: COVIDPROIMPACT

summary:
The COVID-19 pandemic is profoundly changing the way people live and work. After the health impact, it is the mental and psychological impact that reaches varying degrees in the entire world population. The previous Asian epidemics have had a lasting impact on the health professionals concerned.

In France, no study has yet assessed the psychological impact of this health crisis on the level of health professionals. Investigators propose to study prospectively the evolution of the state of stress and anxiety of all the professionals practicing within the gynecology-obstetrics departments of 18 French hospitals.

Investigators also hypothesize that the mental repercussions in terms of stress and anxiety within the same service could be different depending on the professional status and the place of exercise (the French regions being impacted in different ways).

In addition to the epidemiological interest, the results of this study may help us to target regions and professionals who will need psychological support during and after this serious health crisis.

location_facility: Gynécologie-Obstétrique Hôpital de la Mère et de l'Enfant

location_facility: Gynécologie-Obstétrique CHU de Saint Etienne

location_facility: Gynécologie-Obstétrique Hôpital de Hautepierre

location_facility: Gynécologie-Obstétrique Hôpital Jeanne de Flandre - CHRU Lille

location_facility: Gynécologie-Obstétrique Hôpital Antoine Béclère (APHP)

location_facility: Gynécologie-Obstétrique CHU Reims - Institut Mère Enfant Alix de Champagne

location_facility: Gynécologie-Obstétrique CHU Grenoble-Alpes, Hôpital Couple Enfant

location_facility: Gynécologie-Obstétrique Hôpital de la Croix Rousse

location_facility: Gynécologie-Obstétrique Hôpital BICETRE (APHP)

location_facility: Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

location_facility: Gynécologie-Obstétrique Maternité Port-Royal, Groupe Hospitalier Cochin-Broca- Hotel Dieu (APHP)

location_facility: Gynécologie-Obstétrique Hôpital de la Pitié Salpêtrière (APHP)

location_facility: Gynécologie-Obstétrique Hôpital La Conception


title: Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care: the Eurobact II Multinational Cohort Study

acronym: EurobactII

summary: Eurobact II will investigate the mortality and morbidity of hospital-acquired blood stream infections in patients treated in intensive care units (ICU). It will investigate the effects of the micro-organism and its characteristics, such as type and resistance to antibiotics on the infection and its consequences. It will also investigate the effects of the antibiotics and other treatments on survival of patients. Eurobact II will include patients from multiple ICUs in multiple countries.

ReferenceCitation: Tabah A, Koulenti D, Laupland K, Misset B, Valles J, Bruzzi de Carvalho F, Paiva JA, Cakar N, Ma X, Eggimann P, Antonelli M, Bonten MJ, Csomos A, Krueger WA, Mikstacki A, Lipman J, Depuydt P, Vesin A, Garrouste-Orgeas M, Zahar JR, Blot S, Carlet J, Brun-Buisson C, Martin C, Rello J, Dimopoulos G, Timsit JF. Characteristics and determinants of outcome of hospital-acquired bloodstream infections in intensive care units: the EUROBACT International Cohort Study. Intensive Care Med. 2012 Dec;38(12):1930-45. doi: 10.1007/s00134-012-2695-9. Epub 2012 Sep 26.

lead_sponsor: Outcome Rea

location_country: Australia France

location_facility: Reanimation Medicale et Infectieuse-Hopital Bichat


title: Long-term Results of Per-oral Pyloromyotomy for Refractory Gastroparesis

summary:
This is a large multicenter retrospective French cohort conducted in seven French centers that had performed at least five G-POEM procedures at the end of 2017. All patients treated by G-POEM for refractory gastroparesis since April 30, 2014 (first case of GPOEM in France) in these seven centers were included in this study and followed until April 2019. The data were collected retrospectively regarding medical and technical data, and then prospectively for the following data, which were included in a database for each center and combined for analysis.

Gastric Cardinal Symptoms Index (GCSI) was used to evaluate symptoms and their severity. It applies a Likert scale ranging from 0 to 5 (5 being the highest score) for three subscales: satiety (mean of four items), nausea/vomiting (mean of three items), and bloating (mean of two items). The total GCSI score was the mean of the three subscales. A GCSI score ≥ 2.6 is considered moderate gastroparesis and ≥ 3 is considered severe.

Gastric emptying scintigraphy (GES) was used to confirm delayed gastric emptying, since it is considered the gold standard according to the American Society of Neurogastroenterology. Patients consume a radiolabeled meal, receive imaging at specific time-points to determine gastric retention. The exam is pathological when retention is > 90% after 1 hour, > 60% after 2 hours (H2), > 30% after 3 hours (H3), and > 10% after 4 hours (H4). All but one center performed the GES according to the US guidelines: that center performed a 3-hour GES with a local validation of a threshold of 30% retention at H3 to define delayed gastric emptying. A %H4 retention > 30% was defined as severe delayed gastric emptying.

ReferenceCitation: Gonzalez JM, Benezech A, Vitton V, Barthet M. G-POEM with antro-pyloromyotomy for the treatment of refractory gastroparesis: mid-term follow-up and factors predicting outcome. Aliment Pharmacol Ther. 2017 Aug;46(3):364-370. doi: 10.1111/apt.14132. Epub 2017 May 15.

ReferenceCitation: Khashab MA, Ngamruengphong S, Carr-Locke D, Bapaye A, Benias PC, Serouya S, Dorwat S, Chaves DM, Artifon E, de Moura EG, Kumbhari V, Chavez YH, Bukhari M, Hajiyeva G, Ismail A, Chen YI, Chung H. Gastric per-oral endoscopic myotomy for refractory gastroparesis: results from the first multicenter study on endoscopic pyloromyotomy (with video). Gastrointest Endosc. 2017 Jan;85(1):123-128. doi: 10.1016/j.gie.2016.06.048. Epub 2016 Jun 25.

ReferenceCitation: Jacques J, Pagnon L, Hure F, Legros R, Crepin S, Fauchais AL, Palat S, Ducrotté P, Marin B, Fontaine S, Boubaddi NE, Clement MP, Sautereau D, Loustaud-Ratti V, Gourcerol G, Monteil J. Peroral endoscopic pyloromyotomy is efficacious and safe for refractory gastroparesis: prospective trial with assessment of pyloric function. Endoscopy. 2019 Jan;51(1):40-49. doi: 10.1055/a-0628-6639. Epub 2018 Jun 12.

name: Service de Gastroentérologie, CHU Limoges, Limoges, France

family: Jacques

full_name: Jérémie Jacques

given: Jérémie

family: Pagnon

full_name: Lauriane Pagnon

given: Lauriane

name: Service de Biostatistiques, CHU Limoges, Limoges, France

family: Hure

full_name: Florent Hure

given: Florent

family: Legros

full_name: Romain Legros

given: Romain

name: Unité de Vigilance des Essais Cliniques, CHU Limoges, Limoges, France

family: Crepin

full_name: Sabrina Crepin

given: Sabrina

name: Service de Médecine Interne, CHU Limoges, Limoges, France

family: Fauchais

full_name: Anne-Laure Fauchais

given: Anne-Laure

family: Palat

full_name: Sylvain Palat

given: Sylvain

name: Service de Gastroentérologie et Physiologie Digestive, CHU Charles Nicolle, Rouen, France

family: Ducrotté

full_name: Philippe Ducrotté

given: Philippe

family: Marin

full_name: Benoit Marin

given: Benoit

name: Service de Diabétologie, CHU Toulouse, Toulouse, France

family: Fontaine

full_name: Sebastien Fontaine

given: Sebastien

name: Service de Gastroentérologie, CH Brive-la-Gaillarde, Brive-la-Gaillarde, France

family: Boubaddi

full_name: Nour Boubaddi

given: Nour

name: Service de Diabétologie, CHU Limoges, Limoges, France

family: Clement

full_name: Marie-Pierre Clement

given: Marie-Pierre

family: Sautereau

full_name: Denis Sautereau

given: Denis

family: Loustaud-Ratti

full_name: Veronique Loustaud-Ratti

given: Veronique

family: Gourcerol

full_name: Guillaume Gourcerol

given: Guillaume

name: Service de Médecine Nucléaire, CHU Limoges, Limoges, France

family: Monteil

full_name: Jacques Monteil

given: Jacques

journal_name: Endoscopy

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

ReferenceCitation: Revicki DA, Camilleri M, Kuo B, Szarka LA, McCormack J, Parkman HP. Evaluating symptom outcomes in gastroparesis clinical trials: validity and responsiveness of the Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD). Neurogastroenterol Motil. 2012 May;24(5):456-63, e215-6. doi: 10.1111/j.1365-2982.2012.01879.x. Epub 2012 Jan 27.

ReferenceCitation: Abell TL, Camilleri M, Donohoe K, Hasler WL, Lin HC, Maurer AH, McCallum RW, Nowak T, Nusynowitz ML, Parkman HP, Shreve P, Szarka LA, Snape WJ Jr, Ziessman HA; American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. Consensus recommendations for gastric emptying scintigraphy: a joint report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. J Nucl Med Technol. 2008 Mar;36(1):44-54. doi: 10.2967/jnmt.107.048116. Epub 2008 Feb 20.

ReferenceCitation: Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013 Jan;108(1):18-37; quiz 38. doi: 10.1038/ajg.2012.373. Epub 2012 Nov 13.

ReferenceCitation: Ragi O, Jacques J, Branche J, Leblanc S, Vanbiervliet G, Legros R, Pioche M, Rivory J, Chaussade S, Barret M, Wallenhorst T, Barthet M, Kerever S, Gonzalez JM. One-year results of gastric peroral endoscopic myotomy for refractory gastroparesis: a French multicenter study. Endoscopy. 2021 May;53(5):480-490. doi: 10.1055/a-1205-5686. Epub 2020 Jun 23.

name: Service de gastroentérologie, CHU Limoges, France

family: Ragi

full_name: Olivier Ragi

given: Olivier

name: Service de gastroentérologie, CHU Claude Huriez, Lille, France

family: Branche

full_name: Julien Branche

given: Julien

name: Service de gastroentérologie, APHP, Hôpital Cochin, Paris, France

family: Leblanc

full_name: Sarah Leblanc

name: Service de gastroentérologie, CHU L’Archet 2, Nice, France

name: Service de gastroentérologie, HCL Edouard Herriot, Lyon, France

name: Service de gastroentérologie, CHU Pontchailloux, Rennes, France

name: Service de gastroentérologie, APHM, Hôpital Nord, Marseille, France

name: Department of Anesthesiology and Critical Care, Saint Louis Lariboisière Fernand Widal University Hospital, AP-HP, Paris, France

location_facility:
University Hospital
Hospices Civiles Lyon
Cochin Hospital


title: NEoadjuvant Dose-dense MVAC In cOmbination With Durvalumab (MEDI4736) and Tremelimumab in Muscle-invasive Urothelial Carcinoma

acronym: NEMIO

summary: This is an open label, phase I/II clinical trial to evaluate the efficacy and safety of 2 cycles of durvalumab without (Arm A) or with (Arm B) tremelimumab in association with ddMVAC as neoadjuvant therapy in patients with MIUC.

ReferenceCitation: Thibault C, Elaidi R, Vano YA, Rouabah M, Braychenko E, Helali I, Audenet F, Oudard S. Open-label phase II to evaluate the efficacy of NEoadjuvant dose-dense MVAC In cOmbination with durvalumab and tremelimumab in muscle-invasive urothelial carcinoma: NEMIO. Bull Cancer. 2020 Jun;107(5S):eS8-eS15. doi: 10.1016/S0007-4551(20)30281-2.

family: Thibault

full_name: Constance Thibault

given: Constance

family: Elaidi

full_name: Reza Elaidi

given: Reza

family: Vano

full_name: Yann-Alexandre Vano

given: Yann-Alexandre

family: Rouabah

full_name: Mouna Rouabah

given: Mouna

family: Braychenko

full_name: Elena Braychenko

given: Elena

family: Helali

full_name: Imen Helali

given: Imen

family: Audenet

full_name: François Audenet

given: François

family: Oudard

full_name: Stéphane Oudard

given: Stéphane

journal_name: Bulletin du Cancer

ipd_sharing_description: No plan to share

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_facility:
Groupe Hospitalier Pitié-Salpetrière
Centre Antoine Lacassagne
Centre Eugene Marquis
Sasu Roc37
CHU Henri-Mondor
Hôpitaux universitaires de Strasbourg
Hia Begin
Institut Claudius Regaud
Hôpital Saint André, CHU de Bordeaux
Institut Paoli Calmettes
Hôpital Cochin
Centre Leon Berard
Hôpital Européen Georges Pompidou
Institut Gustave Roussy
Institut Mutualiste Montsouris


title: Treatment of Anemia With Epoetin Beta in Low Risk Myelodysplastic Syndrome With Analysis of the Impact on Quality of Life and Functional Capacity of Patients

acronym: EPO-QoL

summary:
Chronic anemia is the symptom most frequently found at diagnosis in low risk myelodysplastic syndrome. It generates an increased rate of morbidity and mortality in this population of patients whose median age is high and the rate of co-mobidities important. The historical treatment is limited to transfusion support with a significant impact on quality of life and the incidence of secondary haemosiderosis, which contributes to the emergence of co-morbidities, especially cardiovascular. Treatment with rHuEPO allows for overall erythroid response in 40-60% of patients treated.

In this trial, the investigators intend to study the interest of a treatment with epoetin beta in patients with anemia <10 g / dL in the context of a myelodysplastic syndrome with IPSS score <1.

In addition to studying the erythroid response, the investigators will measure the impact on quality of life and functional performance.

Patients will receive epoetin beta (60 000UI/week). Response will be assessed after 12 and 24 weeks of treatment.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Centre Hospitalier Universitaire de STRASBOURG

location_facility: Centre Hospitalier de la région d'Annecy


lead_sponsor: UNICANCER

acronym: TIME

location_facility: Centre hospitalier Départemental de Vendée - Les Oudairies

location_facility: Centre de Cancérologie du Grand Montpellier - Clinique Clementville

location_facility: Centre Hospitalier Intercommunal de Toulon

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Centre Hospitalier Intercommunal Cote Basque

title: Randomized Phase II Study of First-line FOLFIRI Plus Cetuximab for 8 Cycles Followed by Either Single-agent Cetuximab as Maintenance Therapy or Observation in Patients With Wild-type KRAS and NRAS Metastatic Colorectal Cancer

summary: National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy.


title: Pilot Study of PegInterferon-Ribavirin-Telaprevir Efficacy and Tolerability in HIV-HCV Coinfected Patients Who Had Previously Failed a PegInterferon-Ribavirin Regimen. (ANRS HC26 TelapreVIH)

acronym: TelapreVIH

summary: This phase II, multicentric, national pilot trial is designed to estimate the sustained virological response rate (SVR) following a 12 weeks treatment by telaprevir combined with a 48 or 72 weeks treatment by peginterferon and ribavirin, based upon the rapid virological response (RVR) at week 8 (4 weeks after telaprevir start), and to compare the observed SVR to 20%, a rate determining a significant therapeutic benefit in this population of patients. The primary endpoint will be the SVR defined as undetectable HCV-RNA measured 24 weeks after the end of therapy (EOT).

ReferenceCitation: Cotte L, Braun J, Lascoux-Combe C, Vincent C, Valantin MA, Sogni P, Lacombe K, Neau D, Aumaitre H, Batisse D, de Truchis P, Gervais A, Michelet C, Morlat P, Vittecoq D, Rosa I, Bertucci I, Chevaliez S, Aboulker JP, Molina JM; French National Agency for Research on AIDS and Viral Hepatitis (ANRS) HC26 Study Group. Telaprevir for HIV/hepatitis C virus-coinfected patients failing treatment with pegylated interferon/ribavirin (ANRS HC26 TelapreVIH): an open-label, single-arm, phase 2 trial. Clin Infect Dis. 2014 Dec 15;59(12):1768-76. doi: 10.1093/cid/ciu659. Epub 2014 Aug 18.

family: Cotte

full_name: L. Cotte

given: L.

family: Braun

full_name: J. Braun

given: J.

family: Lascoux-Combe

full_name: C. Lascoux-Combe

given: C.

family: Vincent

full_name: C. Vincent

family: Valantin

full_name: M.-A. Valantin

family: Sogni

full_name: P. Sogni

given: P.

family: Lacombe

full_name: K. Lacombe

given: K.

family: Neau

full_name: D. Neau

given: D.

family: Aumaitre

full_name: H. Aumaitre

given: H.

family: Batisse

full_name: D. Batisse

family: de Truchis

full_name: P. de Truchis

family: Gervais

full_name: A. Gervais

given: A.

family: Michelet

full_name: C. Michelet

family: Morlat

full_name: P. Morlat

family: Vittecoq

full_name: D. Vittecoq

family: Rosa

full_name: I. Rosa

given: I.

family: Bertucci

full_name: I. Bertucci

family: Chevaliez

full_name: S. Chevaliez

given: S.

family: Aboulker

full_name: J.-P. Aboulker

family: Molina

full_name: J.-M. Molina

family: Bernard

full_name: L. Bernard

family: Cheret

full_name: A. Cheret

name: for the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) HC26 Study Group

title: Telaprevir for HIV/Hepatitis C Virus-Coinfected Patients Failing Treatment With Pegylated Interferon/Ribavirin (ANRS HC26 TelapreVIH): An Open-Label, Single-Arm, Phase 2 Trial

location_facility: Service Maladies Infectieuses et Tropicales, Hôpital de la Croix-Rousse


title: Reference Dose Levels During Fluoroscopically Guided Procedures Performed Using Mobile X-ray Systems in Operating Rooms

summary:
This study is conducted by a working group of the French Society of Medical Physics (SFPM). Its main aim is to establish reference dose levels for the most common procedures performed in operating rooms using mobile X-ray systems, hence helping medical physicists and surgeons to evaluate their practice and optimize patient radiation protection.

This is a multi-centric prospective study involving 73 medical institutions of different categories (public university hospitals, clinics, centers dedicated to cancer treatment, etc.). It consists on progressively collecting anonymous data for 15 to 30 procedures from a list of 62 types of procedures, belonging to 7 surgery specialties (neurosurgery, orthopedic surgery, digestive surgery, urology, cardiology, vascular surgery and multi-specialty). Collected data include patient BMI and information about the X-ray equipment, the medical procedure and the dosimetric parameters. Data collection doesn't require the access to the patient medical record and doesn't impact his medical care.

Proposed dose reference levels will be expressed in terms of KAP (Kerma-Area-Product), fluoroscopy time and air Kerma. Moreover, multiple statistical analyses will be done to investigate the impact of different variables on the procedure X-ray doses.

ipd_sharing_description:
Only the final results of this study will be shared with the medical physicist members of the French Society of Medical Physicist. These results are statistical data analysis based on the collected patient data.

Moreover, the study main results would be probably shared with the scientific community through a published paper in a scientific peer-reviewed journal.

lead_sponsor: Societe Francaise de Physique Medicale


title: Preliminary Validation of the RC2S+ Therapy in Schizophrenia

summary:
Background:

Difficulties in social interactions are a central characteristic of people with schizophrenia, and can be partly explained by impairments of social cognitive processes. According to renown researchers, three to five social cognitive processes are usually altered in schizophrenia: (1) emotional processing; (2) theory of mind (ToM); (3) attributional style; and (4 and 5) social perception and knowledge. The components of social cognition appear to be related to both symptomatology and functioning in everyday life.

New strategies of cognitive remediation have been recently developed to target these deficits and few meta analyses have assessed the extent to which social cognitive remediation programs have led to multiple improvements for schizophrenia patients. Overall, it seems that such therapies showed encouraging results in both patient interest and motivation, and social cognitive processes.

The RC2S therapy is the first individualized and partly computerized program through which patients practice social interactions and develop social cognitive abilities with simulation techniques in a realistic environment.

lead_sponsor: Hôpital le Vinatier

location_facility: centre de réhabilitation - Hôpital le Vinatier

intervention_type: Behavioral


title: Triple Site Ventricular Stimulation for CRT Candidates

acronym: TRIV

summary:
Despite technological progresses the rate of non-responders to cardiac resynchronization therapy (CRT) remains close to 30%. This inconsistent effect of CRT might be due to incomplete resynchronization as dyssynchrony can persist in 25% to 30% of patients during CRT.

One might hypothesize that stimulating the ventricles at a single site is suboptimal and that stimulating multiple left ventricular (LV) or right ventricular (RV) sites may improve ventricular resynchronization and, consequently, its hemodynamic and clinical effects. First studies have suggested that 1 RV + 2 LV pacing sites configurations increased significantly dP/dt, pulse pressure, LV end-diastolic pressure, and is associated with more LV remodeling and better responder rate compared with pacing a single LV site. First studies with 2 RV+LV pacing sites configuration demonstrated increased dP/dt and cardiac output and a decrease of the cardiac dyssynchrony.

The present pilot trial was designed to examine the 6-month safety of biventricular stimulation with 2 right ventricular (RV) and 1 left ventricular (LV) leads - main objective- and to assess its clinical benefit.

ReferenceCitation: Anselme F, Bordachar P, Pasquié JL, Klug D, Leclercq C, Milhem A, Alonso C, Deharo JC, Gras D, Probst V, Piot O, Savouré A. Safety, feasibility, and outcome results of cardiac resynchronization with triple-site ventricular stimulation compared to conventional cardiac resynchronization. Heart Rhythm. 2016 Jan;13(1):183-9. doi: 10.1016/j.hrthm.2015.08.036. Epub 2015 Sep 26.

family: Anselme

full_name: Frederic Anselme

given: Frederic

family: Bordachar

full_name: Pierre Bordachar

given: Pierre

family: Pasquié

full_name: Jean Luc Pasquié

given: Jean Luc

family: Klug

full_name: Didier Klug

given: Didier

family: Leclercq

full_name: Christophe Leclercq

given: Christophe

family: Milhem

full_name: Antoine Milhem

given: Antoine

family: Alonso

full_name: Christine Alonso

given: Christine

family: Deharo

full_name: Jean Claude Deharo

given: Jean Claude

family: Gras

full_name: Daniel Gras

given: Daniel

family: Probst

full_name: Vincent Probst

given: Vincent

family: Piot

full_name: Olivier Piot

given: Olivier

family: Savouré

full_name: Arnaud Savouré

given: Arnaud

journal_name: Heart Rhythm

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_facility:
University hospital of Montpellier
Nouvelles Cliniques Nantaises
University hospital La Timone
Hôpital Saint Louis
University hospital of Lille
University hospital of Bordeaux
University hospital of Nancy
University Hospital of Rennes
University hospital of Rouen
Clinique Bizet
Centre Cardiologique du Nord
University hospital of Nantes


title: Genetic Decryption of Leber Congenital Amaurosis (LCA) in a Large Cohort of Independent Families: Establishment of Genotype-phenotype Correlations and Updating the Clinical Definition of This Retinal Dystrophy

acronym: GENPHENACL

summary:
The main objectives of this study are:

Improve genetic counseling by establishment of prevalences of each of genetic subtypes within a expanded population of patients with LCA taking into account ethnicity of families.
Confirm, refine or modify the genotype-phenotype correlations.

Edit important recommendations for:

The clinical and paraclinical exploration of a new patient based on genotype, especially for extraocular explorations, to book at certain genetic subtypes
Prenatal care of a couple.
Directing families to a therapeutic protocol in progress or in development.
Individualize a panel of families without a mutation in the known genes and identify new genes responsible.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

summary:
The primary objective of this study was to determine the safety and efficacy of teriflunomide in multiple sclerosis (MS) with relapses.

Secondary objectives were:

To determine the effect of teriflunomide on additional magnetic resonance imaging (MRI) variables as well as clinical and quality of life measures.
To investigate the pharmacokinetic and pharmacodynamic relationships.

ReferenceCitation: O'Connor PW, Li D, Freedman MS, Bar-Or A, Rice GP, Confavreux C, Paty DW, Stewart JA, Scheyer R; Teriflunomide Multiple Sclerosis Trial Group; University of British Columbia MS/MRI Research Group. A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurology. 2006 Mar 28;66(6):894-900.

ReferenceCitation: Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.

family: Comi

full_name: Giancarlo Comi

given: Giancarlo

family: Freedman

full_name: Mark S. Freedman

given: Mark S.

family: Meca-Lallana

full_name: José E. Meca-Lallana

given: José E.

family: Vermersch

full_name: Patrick Vermersch

given: Patrick

family: Kim

full_name: Byoung Joon Kim

given: Byoung Joon

family: Parajeles

full_name: Alexander Parajeles

given: Alexander

family: Edwards

full_name: Keith R. Edwards

given: Keith R.

family: Gold

full_name: Ralf Gold

given: Ralf

family: Korideck

full_name: Houari Korideck

given: Houari

family: Chavin

full_name: Jeffrey Chavin

given: Jeffrey

family: Poole

full_name: Elizabeth M. Poole

given: Elizabeth M.

family: Coyle

full_name: Patricia K. Coyle

given: Patricia K.

journal_name: BMC Neurology

repository_institution: University of Ottawa - uO Research

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

lead_sponsor: Sanofi

location_country: Canada France

location_facility:
sanofi-aventis France
Canada


title: Prospective Study in HIV-1 Infected Adult Subjects With HIV-associated Neurocognitive Disorders Despite Effective Antiretroviral Therapy in Plasma, After a Change in HIV Treatment With an Increased of CHARTER Score ≥ 3 (Total Score ≥ 9)

summary: Prospective study in HIV-1 infected adult subjects with HIV-associated neurocognitive disorders despite effective antiretroviral therapy in plasma for more than one year, analyzing the evolution of cognitive disorders and markers of macrophagic inflammation in blood and cerebrospinal fluid, after a change in HIV treatment with an increased of the new scale CHARTER score ≥ 3 (total treatment score to be ≥ 9)

lead_sponsor: GCS IHFB Cognacq-Jay

location_facility: Institut Hospitalier Franco- Britannique

location_facility: Hôpital Mignot Centre Hospitalier de Versailles

location_facility: Centre Hospitalier Intercommunal de Poissy Germain en Laye


title: Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients

acronym: SWITCH

summary:
Primary objective:

Determine the impact of the Oncotype DX Recurrence Score (RS) on the treatment recommendation made (administration of chemotherapy or not, in addition to hormonotherapy) in a HR+, N- or pN1(mi), Her2- breast cancer adjuvant population.

The impact of Oncotype DX on treatment recommendations can be either a decrease in treatment intensity defined as a change in treatment recommendation from chemotherapy plus hormonal therapy to hormonal therapy alone or an increase in treatment intensity defined as a movement from hormonal therapy alone to the addition of chemotherapy to hormonal therapy.

Patients with HR+, N- breast cancer currently represent around 70% of newly diagnosed breast cancers. These are usually good prognosis tumors. However, on the basis of classical clinical and pathological prognostic parameters and markers, the international consensus guidelines recommend treatment with hormone- and chemotherapy in 85-95% of the cases. Considering the natural disease history, such as documented by the EBCTCG meta-analysis, more than 50% of these patients are overtreated, which leads to unnecessary side effects and costs to the health system and to the society.

Oncotype DX appears to be well adapted to therapeutic de-escalation as it targets HR+, N- patients and is performed on fixed paraffin embedded tissue (FPET). It is therefore best adapted to daily clinical practice as it does not necessitate any specific surgical procedure or tissue freezing.

The prognostic and predictive value of Oncotype DX in ER+, N- patients has been validated on three large adjuvant randomized trials (NASBP B-14, NSABP B-20, and the ATAC study). The test has been commercially available in the USA since 2004, and is being used for more than 50% of the HR+ N- patients in this country.

While Oncotype DX has been validated in the USA, it needs to be independently evaluated in France, in the context of the local treatment guidelines and habits, to provide data that are meaningful to the French health system and to the French medical community.

lead_sponsor: Genomic Health®, Inc.

location_facility:
Centre d'Oncologie Médicale de Gentilly
Hôpital TENON
Centre Val d'Aurelle
Centre Jean Perrin
CHRU Besançon
Centre Azuréen de Cancérologie


title: A Phase I Dose Escalation Study of Clofarabine Given in Combination With Multi-agent Therapy for Remission Induction in Pediatric Patients With Acute Lymphoblastic Leukemia in First Relapse or Refractory to First Line Therapy -

acronym: Vandevol

summary: The purpose of this study is to determine Maximum Tolerated Dosage (MTD), Dosage Limited Toxicities (DLT), and the Rate Phase 2 Dosage of clofarabine when used in combination with etoposide, asparaginase, mitoxantrone and dexamethasone and to assess the feasibility and safety of this combination regimen to treat children with high risk relapsed or refractory acute lymphoblastic leukemia (ALL).

lead_sponsor: University Hospital, Lille

location_facility:
Besançon University Hospital
Lille University Hospital


title: Stress at Work and Infectious Risk in Patients and Caregivers

acronym: STRIPPS

summary:
In hospitals, the improvement of working conditions is often considered secondarily to patient satisfaction. Previous studies, showing statistically significant relationships, suggested the impact of hospital departments' organization (staff / patient ratio, bed distribution, caregiver's assignment), of the work environment, and the working conditions on the infectious risk at the hospital departments. In addition, organizational hospital constraints and the organization of care could equally have a major impact on the physical and psychological health of care workers (stress, fatigue, job satisfaction). To date, available data suggest that determinants of occupational stress and fatigue are multifactorial.

This research aims to develop an interdisciplinary approach to link two phenomena that are often studied independently while they are closely intertwined: working conditions and infectious risk in hospitals departments. Their main objective is to study the relationship between stress and caregiver fatigue at the work, organizational determinants and infectious risk for patients (healthcare-associated infections: HAIs) and for caregivers (blood exposure accidents: BEAs). The secondary objective is to analyze how the individual characteristics of the staff, the characteristics of their employment, and the overall organization in the hospital departments where they work interact to explain their physical and psychological state of health, on the one hand, and their behavior face to work (absenteeism, turnover and hand hygiene) on the other hand. The ultimate goal of this research is to be able to propose organizational strategies aimed at both reducing the probability of occurrence of healthcare-associated infections and preventing occupational risks for caregivers.


title: Stoke Volume Measurements During Changes in Cardiac Preload: Are Pulse Contour Analysis (CLEARSIGHT) and Transthoracic Bioelectrical Impedance (NICCOMO) Equivalent?

acronym: ConBi-Car

summary:
Fluid therapy guided by stroke volume response to repeated fluid challenges is used for hemodynamic optimization during general anesthesia. Two types of devices that measure stroke volume non-invasively are primarily available for intermediate-risk surgery under general anesthesia. They are based on two different techniques, (1) pulse contour analysis, and (2) transthoracic bioimpedance. They have never been compared with each other. Therefore, it is not known (1) whether they are interchangeable for the measurement of stroke volume changes (usually assessed as the "concordance" of two techniques), and (2) whether one is better than the other.

The aim is to study the concordance of these two non-invasive hemodynamic devices. it will use both of them in patients undergoing intermediate risk surgery. They will be tested during modifications of cardiac preload induced by Trendelenburg and anti-Trendelenburg positioning, as well as during intraoperative fluid challenges, vasopressor boluses and alveolar recruitment maneuvers.


title: Evaluation of Clinical and Biomechanical Correlation During Return to Sport After Anterior Cruciate Ligament Injury

acronym: REPILOG

summary:
Comparison of two groups of subjets (ACL injury who return to sport) and control group non-injured about clinical and biomechanical data :

clinical test
functional test
motion analysis of 2 sport exercises
tibial translation
isokinetic evaluation

status: Terminated

ReferenceCitation: Granan LP, Bahr R, Steindal K, Furnes O, Engebretsen L. Development of a national cruciate ligament surgery registry: the Norwegian National Knee Ligament Registry. Am J Sports Med. 2008 Feb;36(2):308-15. Epub 2007 Nov 7.

ReferenceCitation: Olsen OE, Myklebust G, Engebretsen L, Bahr R. Injury mechanisms for anterior cruciate ligament injuries in team handball: a systematic video analysis. Am J Sports Med. 2004 Jun;32(4):1002-12.

ReferenceCitation: Herbst E, Hoser C, Hildebrandt C, Raschner C, Hepperger C, Pointner H, Fink C. Functional assessments for decision-making regarding return to sports following ACL reconstruction. Part II: clinical application of a new test battery. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1283-91. doi: 10.1007/s00167-015-3546-3. Epub 2015 Feb 28.

ReferenceCitation: Crawford SN, Waterman BR, Lubowitz JH. Long-term failure of anterior cruciate ligament reconstruction. Arthroscopy. 2013 Sep;29(9):1566-71. doi: 10.1016/j.arthro.2013.04.014. Epub 2013 Jun 29. Review.

ReferenceCitation: Webster KE, Feller JA, Leigh WB, Richmond AK. Younger patients are at increased risk for graft rupture and contralateral injury after anterior cruciate ligament reconstruction. Am J Sports Med. 2014 Mar;42(3):641-7. doi: 10.1177/0363546513517540. Epub 2014 Jan 22.

ReferenceCitation: Ford KR, Myer GD, Hewett TE. Valgus knee motion during landing in high school female and male basketball players. Med Sci Sports Exerc. 2003 Oct;35(10):1745-50.

ReferenceCitation: Hewett TE, Myer GD, Ford KR, Heidt RS Jr, Colosimo AJ, McLean SG, van den Bogert AJ, Paterno MV, Succop P. Biomechanical measures of neuromuscular control and valgus loading of the knee predict anterior cruciate ligament injury risk in female athletes: a prospective study. Am J Sports Med. 2005 Apr;33(4):492-501. Epub 2005 Feb 8.

ReferenceCitation: Paterno MV, Schmitt LC, Ford KR, Rauh MJ, Myer GD, Huang B, Hewett TE. Biomechanical measures during landing and postural stability predict second anterior cruciate ligament injury after anterior cruciate ligament reconstruction and return to sport. Am J Sports Med. 2010 Oct;38(10):1968-78. doi: 10.1177/0363546510376053. Epub 2010 Aug 11.

lead_sponsor: University Hospital, Brest


title: Prevalence of Strokes Secondary to a Reversible Cerebral Vasoconstriction Attributable to Cannabis Consumption in Young Subjects (≤ 45 Years) Hospitalized for an Ischaemic Stroke

acronym: CANNASTROKE

summary:
Incidence of strokes has increased these last 20 years in young population. This rise could be linked to alcohol, tobacco or drug use like cannabis. Cannabis has previously been descripted as a potential factor of reversible vasoconstriction. The main objective is to show that an exhaustive assessment of a stroke facing a young person frequently lead to a diagnostic of reversible vasoconstriction due to cannabis use. Evaluation will focus on prevalence of strokes secondary to a reversible vasoconstriction attributable to cannabis in young subjects.

There's a real public healthcare interest in terms of primary and secondary prevention to evaluate the role of cannabis as a risk factor of stroke in young population.

primary_purpose: Prevention

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Les Hôpitaux Universitaires de Strasbourg


title: Interest of Low-dose Landiolol Administration After Cardiac Surgery for the Prevention of Postoperative Atrial Fibrillation

acronym: LANDIPROTEC

summary:
Postoperative atrial fibrillation (POAF) is a common complication that occurs in 30-50% of patients after cardiac surgery and increases morbidity and mortality and hospital length of stay. During the perioperative period, the discontinuation of beta-blocker treatment is known to be a risk factor for developing POAF in patient undergoing cardiac surgery. Early beta-blocker reintroduction is associated with lower incidence of POAF. Unfortunately, side effects of currently available beta-blockers (including esmolol), such as low blood pressure and excessive bradycardia and/or their extended duration of action, limit their use in the post-operative period especially for prevention.

Landiolol, an ultra-short acting injectable beta-blocker, offers the advantage of significantly limiting low blood pressure events while increasing therapeutic efficacy in the treatment of POAF in cardiac and non-cardiac surgery. Landiolol, when used at low dose in the postoperative period, has been showed to reduce the incidence of POAF with no increased incidence of side effect as compared to standard of care. The limitation is that these promising data come from single center studies with limited samples and conducted exclusively in Japanese population. If landiolol is approved for use in the treatment of atrial fibrillation in non-Asian patients, there are no data on the prevention of POAF in cardiac surgery.

The objective of this multicenter, double-blind, randomized, placebo- controlled phase III trial is to confirm that landiolol postoperative infusion is associated with lower incidence of POAF without excess of adverse events as compared to standard of care in a non-Asian population after cardiac surgery with sternotomy.

lead_sponsor: CMC Ambroise Paré

location_facility:
Hôpital Privé Jacques Cartier
CMC Ambroise Paré