title: Impact of Interictal Electroencephalographic Abnormalities on the Stability of Attention in the Epilepsies in Adults and Children

acronym: COGNIT-AIC

summary:
Cognitive disorders are a major problem in patients with epilepsy. One hypothesis is that the anomalies EEGs (AIC) may be responsible for short periods of attentional fluctuations causing a reduction of intellectual efficiency of patients. In this project, we propose to evaluate the impact of AIC on cognitive performance, specifically on attentional performance (central parameter of cognitive functioning) through the use of a computerized cognitive test (called STABILO, detailed below after) to measure, with good temporal sampling, the level of attentional engagement of patients in relation to their EEG activity.

The originality of this study lies in the synchronization of two examinations usually made independently (EEG and psychometric testing), respecting a precise temporal coupling. The aim is to provide clinicians with a tool to assess very quickly attentional fluctuations in epileptic patients, and to assess the potential impact of AIC on the occurrence of these changes, with possible therapeutic implications (treatment of AIC and / or specific treatment of attention deficit disorder).

The main objective of this study is to assess whether the presence of AIC EEG can induce a weakening of attentional performance.

location_facility:
HCL
University Hospital Grenoble


title: Assessment of Cerebellar Stimulation Effect on Motor Learning in Ageing Population and Stroke Patients

acronym: MADECCS

summary: This study will assess the putative advantages of cerebellar stimulation on motor learning abilities of stroke patients. In order to have a control group to refer to, the effect of cerebellar stimulation on healthy young and old participants will also be assessed.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Hospitalier St Anne

location_facility: Centre de Recherche Clinique (CRC) - CHSA

location_facility: Service de Médecine Physique et Rédaptation

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


title: Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer : a Pilot Study

acronym: COG-ANGIO

summary: Longitudinal study nonrandomized, multicenter observational descriptive monitoring patients treated with anti-angiogenic for metastatic kidney cancer

status: Terminated

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Francois Baclesse

location_facility:
Hôpital Georges Pompidou
Centre Henri Becquerel
CHU
Institut Gustave Roussy
Centre François BACLESSE

lead_sponsor_type: industriel


title: Impact of Polyethylene Terephthalate Micronet Mesh-Covered Stent (MGuard) on Coronary Microcirculation's Lesions in Patients With ST or Non ST-segment Elevation Myocardial Infarction (STE and NSTE-ACS): Assessment by Index of Microcirculatory Resistance (IMR)

acronym: GUARDIANCORY

summary:
NSTE-ACS represents the most frequent indication for coronary angiography and percutaneous coronary intervention (PCI) worldwide. PCI permit to reestablished coronary flow but effectiveness of PCI within thrombus containing lesions is limited by the risk of occurrence of distal embolization and no-reflow phenomenon. Distal embolization lead to coronary microcirculation lesions. This complication is related to poor prognosis.

MGuard stent is a stainless-steel closed cell stent covered with an ultra-thin polymer mesh sleeve, which allows to prevent distal embolization during percutaneous coronary intervention in ST-segment-elevation myocardial infarction.

Index of microcirculatory resistance (IMR) is a validated method to assess coronary microcirculation.

Accordingly, the purpose of this study is to demonstrate that MGuard micronet mesh-covered stent prevent distal embolization and microvascular reperfusion impairment during primary PCI, compared with a bare metal stent (BMS) and drug eluting stent (DES) in patients with NSTE-ACS, assessed by Index of microcirculatory resistance.

ReferenceType: background

ReferenceCitation: Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group . 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29.

ReferenceCitation: Silen W, Machen TE, Forte JG. Acid-base balance in amphibian gastric mucosa. Am J Physiol. 1975 Sep;229(3):721-30.

ReferenceCitation: Pride YB, Mohanavelu S, Zorkun C, Kunadian V, Giugliano RP, Newby LK, Braunwald E, Califf RM, Harrington RA, Gibson CM; EARLY ACS Investigators. Association between angiographic complications and clinical outcomes among patients with acute coronary syndrome undergoing percutaneous coronary intervention: an EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non-ST-Segment Elevation Acute Coronary Syndrome) angiographic substudy. JACC Cardiovasc Interv. 2012 Sep;5(9):927-35. doi: 10.1016/j.jcin.2012.05.007.

ReferenceCitation: Gibson CM, Kirtane AJ, Morrow DA, Palabrica TM, Murphy SA, Stone PH, Scirica BM, Jennings LK, Herrmann HC, Cohen DJ, McCabe CH, Braunwald E; TIMI Study Group. Association between thrombolysis in myocardial infarction myocardial perfusion grade, biomarkers, and clinical outcomes among patients with moderate- to high-risk acute coronary syndromes: observations from the randomized trial to evaluate the relative PROTECTion against post-PCI microvascular dysfunction and post-PCI ischemia among antiplatelet and antithrombotic agents-Thrombolysis In Myocardial Infarction 30 (PROTECT-TIMI 30). Am Heart J. 2006 Oct;152(4):756-61.

ReferenceCitation: Gibson CM, de Lemos JA, Murphy SA, Marble SJ, McCabe CH, Cannon CP, Antman EM, Braunwald E; TIMI Study Group. Combination therapy with abciximab reduces angiographically evident thrombus in acute myocardial infarction: a TIMI 14 substudy. Circulation. 2001 May 29;103(21):2550-4.

ReferenceCitation: De Bruyne B, Pijls NH, Smith L, Wievegg M, Heyndrickx GR. Coronary thermodilution to assess flow reserve: experimental validation. Circulation. 2001 Oct 23;104(17):2003-6.

ReferenceCitation: Steg PG, Dabbous OH, Feldman LJ, Cohen-Solal A, Aumont MC, López-Sendón J, Budaj A, Goldberg RJ, Klein W, Anderson FA Jr; Global Registry of Acute Coronary Events Investigators. Determinants and prognostic impact of heart failure complicating acute coronary syndromes: observations from the Global Registry of Acute Coronary Events (GRACE). Circulation. 2004 Feb 3;109(4):494-9. Epub 2004 Jan 26.

ReferenceCitation: Cuisset T, Hamilos M, Melikian N, Wyffels E, Sarma J, Sarno G, Barbato E, Bartunek J, Wijns W, De Bruyne B. Direct stenting for stable angina pectoris is associated with reduced periprocedural microcirculatory injury compared with stenting after pre-dilation. J Am Coll Cardiol. 2008 Mar 18;51(11):1060-5. doi: 10.1016/j.jacc.2007.11.059.

ReferenceCitation: Holm J, Häggendal E, Lundberg D, Scherstén T, Stenberg K, Wetterqvist H. Effect of lumbar sympathetic blockade and chlorpromazine-induced adrenergic alpha-receptor blockade on skin temperature in peripheral arterial diseases. J Cardiovasc Surg (Torino). 1976 Jan-Feb;17(1):69-71.

ReferenceCitation: Aarnoudse W, Fearon WF, Manoharan G, Geven M, van de Vosse F, Rutten M, De Bruyne B, Pijls NH. Epicardial stenosis severity does not affect minimal microcirculatory resistance. Circulation. 2004 Oct 12;110(15):2137-42. Epub 2004 Oct 4.

ReferenceCitation: Nijveldt R, Beek AM, Hirsch A, Stoel MG, Hofman MB, Umans VA, Algra PR, Twisk JW, van Rossum AC. Functional recovery after acute myocardial infarction: comparison between angiography, electrocardiography, and cardiovascular magnetic resonance measures of microvascular injury. J Am Coll Cardiol. 2008 Jul 15;52(3):181-9. doi: 10.1016/j.jacc.2008.04.006.

ReferenceCitation: Henriques JP, Zijlstra F, Ottervanger JP, de Boer MJ, van 't Hof AW, Hoorntje JC, Suryapranata H. Incidence and clinical significance of distal embolization during primary angioplasty for acute myocardial infarction. Eur Heart J. 2002 Jul;23(14):1112-7.

ReferenceCitation: Kaul P, Ezekowitz JA, Armstrong PW, Leung BK, Savu A, Welsh RC, Quan H, Knudtson ML, McAlister FA. Incidence of heart failure and mortality after acute coronary syndromes. Am Heart J. 2013 Mar;165(3):379-85.e2. doi: 10.1016/j.ahj.2012.12.005. Epub 2013 Jan 22.

ReferenceCitation: Ng MK, Yeung AC, Fearon WF. Invasive assessment of the coronary microcirculation: superior reproducibility and less hemodynamic dependence of index of microcirculatory resistance compared with coronary flow reserve. Circulation. 2006 May 2;113(17):2054-61. Epub 2006 Apr 24.

ReferenceCitation: Fearon WF, Balsam LB, Farouque HM, Caffarelli AD, Robbins RC, Fitzgerald PJ, Yock PG, Yeung AC. Novel index for invasively assessing the coronary microcirculation. Circulation. 2003 Jul 1;107(25):3129-32. Epub 2003 Jun 23. Erratum in: Circulation. 2003 Dec 23;108(25):3165.

ReferenceCitation: Akdeniz C, Umman S, Nisanci Y, Umman B, Bugra Z, Aslanger EK, Kaplan A, Yilmaz A, Teker E, Güz G, Polat N, Sezer M. Percutaneous coronary intervention increases microvascular resistance in patients with non-ST-elevation acute coronary syndrome. EuroIntervention. 2013 Jun 22;9(2):228-34. doi: 10.4244/EIJV9I2A38.

ReferenceCitation: Fearon WF, Shah M, Ng M, Brinton T, Wilson A, Tremmel JA, Schnittger I, Lee DP, Vagelos RH, Fitzgerald PJ, Yock PG, Yeung AC. Predictive value of the index of microcirculatory resistance in patients with ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2008 Feb 5;51(5):560-5. doi: 10.1016/j.jacc.2007.08.062.

ReferenceCitation: Napodano M, Ramondo A, Tarantini G, Peluso D, Compagno S, Fraccaro C, Frigo AC, Razzolini R, Iliceto S. Predictors and time-related impact of distal embolization during primary angioplasty. Eur Heart J. 2009 Feb;30(3):305-13. doi: 10.1093/eurheartj/ehn594. Epub 2009 Jan 19.

ReferenceCitation: Fearon WF, Low AF, Yong AS, McGeoch R, Berry C, Shah MG, Ho MY, Kim HS, Loh JP, Oldroyd KG. Prognostic value of the Index of Microcirculatory Resistance measured after primary percutaneous coronary intervention. Circulation. 2013 Jun 18;127(24):2436-41. doi: 10.1161/CIRCULATIONAHA.112.000298. Epub 2013 May 16.

ReferenceCitation: Stone GW, Abizaid A, Silber S, Dizon JM, Merkely B, Costa RA, Kornowski R, Abizaid A, Wojdyła R, Maehara A, Dressler O, Brener SJ, Bar E, Dudek D. Prospective, Randomized, Multicenter Evaluation of a Polyethylene Terephthalate Micronet Mesh-Covered Stent (MGuard) in ST-Segment Elevation Myocardial Infarction: The MASTER Trial. J Am Coll Cardiol. 2012 Nov 6;60(19):1975-84. doi: 10.1016/j.jacc.2012.09.004.

ReferenceCitation: Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, Kedev S, Thabane L, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemelä K, Steg PG, Bernat I, Xu Y, Cantor WJ, Overgaard CB, Naber CK, Cheema AN, Welsh RC, Bertrand OF, Avezum A, Bhindi R, Pancholy S, Rao SV, Natarajan MK, ten Berg JM, Shestakovska O, Gao P, Widimsky P, Džavík V; TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015 Apr 9;372(15):1389-98. doi: 10.1056/NEJMoa1415098. Epub 2015 Mar 16.

family: Jolly

full_name: Sanjit S. Jolly

given: Sanjit S.

sequence: first

family: Cairns

full_name: John A. Cairns

given: John A.

sequence: additional

family: Yusuf

full_name: Salim Yusuf

given: Salim

family: Meeks

full_name: Brandi Meeks

given: Brandi

family: Pogue

full_name: Janice Pogue

given: Janice

family: Rokoss

full_name: Michael J. Rokoss

given: Michael J.

family: Kedev

full_name: Sasko Kedev

given: Sasko

family: Thabane

full_name: Lehana Thabane

given: Lehana

family: Stankovic

full_name: Goran Stankovic

given: Goran

family: Moreno

full_name: Raul Moreno

given: Raul

family: Gershlick

full_name: Anthony Gershlick

given: Anthony

family: Chowdhary

full_name: Saqib Chowdhary

given: Saqib

family: Lavi

full_name: Shahar Lavi

given: Shahar

family: Niemelä

full_name: Kari Niemelä

given: Kari

family: Steg

full_name: Philippe Gabriel Steg

given: Philippe Gabriel

family: Bernat

full_name: Ivo Bernat

given: Ivo

family: Xu

full_name: Yawei Xu

given: Yawei

family: Cantor

full_name: Warren J. Cantor

given: Warren J.

title: Randomized Trial of Primary PCI with or without Routine Manual Thrombectomy

ReferenceCitation: Napodano M, Dariol G, Al Mamary AH, Marra MP, Tarantini G, D'Amico G, Frigo AC, Buja P, Razzolini R, Iliceto S. Thrombus burden and myocardial damage during primary percutaneous coronary intervention. Am J Cardiol. 2014 May 1;113(9):1449-56. doi: 10.1016/j.amjcard.2014.01.423. Epub 2014 Feb 12.

ReferenceCitation: Layland J, Carrick D, McEntegart M, Ahmed N, Payne A, McClure J, Sood A, McGeoch R, MacIsaac A, Whitbourn R, Wilson A, Oldroyd K, Berry C. Vasodilatory capacity of the coronary microcirculation is preserved in selected patients with non-ST-segment-elevation myocardial infarction. Circ Cardiovasc Interv. 2013 Jun;6(3):231-6. doi: 10.1161/CIRCINTERVENTIONS.112.000180. Epub 2013 Jun 11.

location_facility:
Annecy Hospital
University Hospital Grenoble


title: Prospective, Longitudinal Study of the Natural History and Functional Status of Patients With Myotubular Myopathy (MTM)

acronym: MTM

summary: This is a prospective, non-interventional, longitudinal study of the natural history and function of approximately 60 patients with MTM from the United States, Canada and Europe. The duration of the study, including the enrollment period, will be 36 months. Data from the study will be used to characterize the disease course of MTM and determine which outcome measures will be the best to assess the efficacy of potential therapies.

status: Completed

ReferenceCitation: Herman GE, Finegold M, Zhao W, de Gouyon B, Metzenberg A. Medical complications in long-term survivors with X-linked myotubular myopathy. J Pediatr. 1999 Feb;134(2):206-14.

ReferenceCitation: Jungbluth H, Sewry CA, Buj-Bello A, Kristiansen M, Ørstavik KH, Kelsey A, Manzur AY, Mercuri E, Wallgren-Pettersson C, Muntoni F. Early and severe presentation of X-linked myotubular myopathy in a girl with skewed X-inactivation. Neuromuscul Disord. 2003 Jan;13(1):55-9.

ReferenceCitation: McEntagart M, Parsons G, Buj-Bello A, Biancalana V, Fenton I, Little M, Krawczak M, Thomas N, Herman G, Clarke A, Wallgren-Pettersson C. Genotype-phenotype correlations in X-linked myotubular myopathy. Neuromuscul Disord. 2002 Dec;12(10):939-46.

ReferenceCitation: Jungbluth H, Wallgren-Pettersson C, Laporte J. Centronuclear (myotubular) myopathy. Orphanet J Rare Dis. 2008 Sep 25;3:26. doi: 10.1186/1750-1172-3-26. Review.

ReferenceType: derived

ReferenceCitation: Annoussamy M, Lilien C, Gidaro T, Gargaun E, Chê V, Schara U, Gangfuß A, D'Amico A, Dowling JJ, Darras BT, Daron A, Hernandez A, de Lattre C, Arnal JM, Mayer M, Cuisset JM, Vuillerot C, Fontaine S, Bellance R, Biancalana V, Buj-Bello A, Hogrel JY, Landy H, Servais L. X-linked myotubular myopathy: A prospective international natural history study. Neurology. 2019 Apr 16;92(16):e1852-e1867. doi: 10.1212/WNL.0000000000007319. Epub 2019 Mar 22.

family: Annoussamy

full_name: Mélanie Annoussamy

given: Mélanie

family: Lilien

full_name: Charlotte Lilien

given: Charlotte

family: Gidaro

full_name: Teresa Gidaro

given: Teresa

family: Gargaun

full_name: Elena Gargaun

given: Elena

family: Chê

full_name: Virginie Chê

given: Virginie

family: Schara

full_name: Ulrike Schara

given: Ulrike

family: Gangfuß

full_name: Andrea Gangfuß

given: Andrea

family: D'Amico

full_name: Adele D'Amico

given: Adele

family: Dowling

full_name: James J. Dowling

given: James J.

family: Darras

full_name: Basil T. Darras

given: Basil T.

family: Daron

full_name: Aurore Daron

given: Aurore

family: Hernandez

full_name: Arturo Hernandez

given: Arturo

family: de Lattre

full_name: Capucine de Lattre

given: Capucine

family: Arnal

full_name: Jean-Michel Arnal

given: Jean-Michel

family: Mayer

full_name: Michèle Mayer

given: Michèle

family: Cuisset

full_name: Jean-Marie Cuisset

given: Jean-Marie

family: Vuillerot

full_name: Carole Vuillerot

given: Carole

family: Fontaine

full_name: Stéphanie Fontaine

given: Stéphanie

family: Bellance

full_name: Rémi Bellance

given: Rémi

family: Biancalana

full_name: Valérie Biancalana

given: Valérie

family: Buj-Bello

full_name: Ana Buj-Bello

given: Ana

family: Hogrel

full_name: Jean-Yves Hogrel

given: Jean-Yves

family: Landy

publisher: Ovid Technologies (Wolters Kluwer Health)

title: X-linked myotubular myopathy

location_country:
Italy
United States
Germany
France
Belgium
Spain
Canada

location_facility: Hôpital Femme Mère Enfant, CHU Lyon Escale

location_facility: Institut de Myologie, GH Pitié Salpêtrière, Bâtiment Babinski

location_facility: Boston Children's Hospital, 300 Longwood Avenue

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Hospital for Sick Children, 555 University Avenue


title: Assessing the Evolution and Determinants of Quality of Life in Elderly Cancer Patients and Their Caregivers: a Prospective Multicenter Observational Cohort Study.

acronym: DEQOLAGE

summary:
Patients face multiple stresses and challenges in the aftermath of cancer diagnosis. Despite needs perceived by elderly patients might differ from those of younger patients, there is a paucity of published data assessing the specific evolution and relevant determinants of health-related quality of life (HRQoL) in older patients with cancer. Such determinants may include cancer type/location/stage, treatment type/intensity, comorbidities, nutritional status or socioeconomic features, but also practical organization of care -frequency, geographical distance, supporting measures -, or psychosocial and material support - social network, housing conditions and contextual neighborhood features. Comparatively to dementia or cancer in younger patients, little is known in the oncogeriatric field of the impact on caregivers' perceived burden and HRQol of the support they provide to patients. Further, the potential interactions between patients' and caregivers' HRQoL remain largely unknown, while caregivers are often themselves old with chronic diseases and/or daily living activities' limitations.

The DEQOLAGE study is a prospective observational cohort study that aims to describe the HRQoL of patients aged over 70 years with a colorectal or prostatic cancer during the first year following the diagnosis of the disease as well as the HRQoL and burden in their main caregivers. This study will allow a comprehensive assessment of multiple determinants of HRQoL operating at different levels, including individual (cancer type/location/stage, treatment type/intensity, comorbidities, nutritional status or socioeconomic features), contextual (social network, housing conditions and contextual neighborhood features) and organizational factors (frequency, geographical distance, supporting measures). We also hypothesize that complex interactions may operate between patient's and caregiver's HRQoL and perceived burden. Quality of life measurement will be based on two recent scales specifically designed for the elderly to confirm their psychometric properties and in-field feasibility.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Saint Louis
Hôpital Henri Mondor
CHRU Nancy


title: Prospective Evaluation of Topical Analgesia Using a Lidocaine/Prilocaine Cream for Laceration Repair in the Emergency Department

summary: The purpose of this study is to determine if topical analgesia using a lidocaine and prilocaine cream improves pain scores compared to the usual local anesthesia using subcutaneous 1% lidocaine and adrenalin injected near the laceration.

ReferenceType: result

ReferenceCitation: McNulty RJ, Handley TP, Devlin MF. Reducing the need for general anaesthesia in children: use of LAT gel in treating facial lacerations. Br J Oral Maxillofac Surg. 2013 Sep;51(6):e130-1. doi: 10.1016/j.bjoms.2012.04.259. Epub 2012 Jun 12.

family: McNulty

full_name: Richard J. McNulty

given: Richard J.

family: Handley

full_name: Thomas P.B. Handley

given: Thomas P.B.

family: Devlin

full_name: Mark F. Devlin

given: Mark F.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: British Journal of Oral and Maxillofacial Surgery

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: White NJ, Kim MK, Brousseau DC, Bergholte J, Hennes H. The anesthetic effectiveness of lidocaine-adrenaline-tetracaine gel on finger lacerations. Pediatr Emerg Care. 2004 Dec;20(12):812-5.

lead_sponsor: Centre Hospitalier le Mans

location_facility:
Centre Hospitalier Le Mans
Centre Hospitalier Universitaire Angers

intervention_type: Drug


type: Other Identifier

title: National Oesophageal and Gastric Carcinomas Data Base Construction: the FREGAT (French EsoGastric Tumours) Data Base

acronym: FREGAT

summary: This retrospective study aims at evaluating the outcomes of gastrointestinal stromal tumor after surgery.

status: Recruiting

ReferenceCitation: Mariette C, Renaud F, Piessen G, Gele P, Copin MC, Leteurtre E, Delaeter C, Dib M, Clisant S, Harter V, Bonnetain F, Duhamel A, Christophe V, Adenis A; Fregat Working Group. The FREGAT biobank: a clinico-biological database dedicated to esophageal and gastric cancers. BMC Cancer. 2018 Feb 6;18(1):139. doi: 10.1186/s12885-018-3991-8.

family: Mariette

full_name: Christophe Mariette

given: Christophe

family: Renaud

full_name: Florence Renaud

given: Florence

family: Piessen

full_name: Guillaume Piessen

given: Guillaume

family: Gele

full_name: Patrick Gele

given: Patrick

family: Copin

full_name: Marie-Christine Copin

given: Marie-Christine

family: Leteurtre

full_name: Emmanuelle Leteurtre

given: Emmanuelle

family: Delaeter

full_name: Christine Delaeter

given: Christine

family: Dib

full_name: Malek Dib

given: Malek

family: Clisant

full_name: Stéphanie Clisant

family: Harter

full_name: Valentin Harter

given: Valentin

family: Bonnetain

full_name: Franck Bonnetain

given: Franck

family: Duhamel

full_name: Alain Duhamel

given: Alain

family: Christophe

full_name: Véronique Christophe

given: Véronique

family: Adenis

full_name: Antoine Adenis

given: Antoine

currency_apc_doaj: GBP

journal_name: BMC Cancer

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Lille

repository_normalized: HAL

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

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

location_facility: Hospices Civils de Lyon (Pierre Bénite,Edouard Herriot, La Croix Rousse)

location_facility: Hopital Estaing - Chu63 - Clermont Ferrand


title: Assessment of Biomarkers Initially Identified in Whole Blood by DNA Microarrays in Patients With Aggressive Lymphoma BMS_LyTrans

acronym: BMS-LyTrans

summary: Diffuse Large B-cell Lymphoma (DLBCL) is the most frequent high grade lymphoma in adults. Although immunotherapy has improved its prognosis, DLBCL is a heterogeneous disease with patients exhibiting a wide range of outcomes with a 5-year overall survival ranging between 55 to 94% depending of the International Prognostic Index factor. Diagnostic and prognostic biomarkers are mandatory to optimize treatment. Transcriptomics has been used to detect such new biomarkers using microarrays analyses applied to RNA collected from total tumor tissues or cell extracts. Molecular prognostic factors have been thoroughly studied in DLBCL tumor tissues. However, it is a big challenge to obtain transcriptomic-qualified tumor samples in a multicentric and prospective clinical trial. Coordinating nvestigator hypothesized that blood may be a deep source of native and secreted analytes and therefore carries transcriptomic signatures related to DLBCL and its prognosis. This project is organized in the extension of the GOELAMS-075 clinical trial which concerns aggressive DLBCL.

time_perspective: Other

lead_sponsor: Rennes University Hospital

location_facility: Bordeaux University Hospital ( Haut-Lévêque Hospital)

status_simplified: Completed


title: Efficiency of a Tight Monitoring by a Nurse Practitioner of Rheumatoid Arthritis (RA) Patients in Remission (or Low Disease Activity) Under Rituximab to Detect Early Relapse of the Disease

acronym: SIERRA

summary:
Rheumatoid arthritis (RA) is a progressive disease that affects mainly small and medium joints and, in the absence of appropriate background therapy, leads to progressive joint destruction, functional, psychological, social and occupational repercussions.

Several biomedicine treat this pathology, including rituximab (RTX). It is recommended to evaluate the therapeutic response to RTX and re-administer it from the 24th week when the goal of remission has not been achieved. However, the optimal modality for reprocessing remains to be determined.

To this end, different approaches have been explored, such as lymphocyte typing or ultrasound monitoring. The pace of these examinations, however, remains wide and their cost is not negligible. This is why we propose here to explore the track of a tight follow-up nurse DAS28.

The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier than the current medical follow-up.

The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier than the current medical follow-up

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Rouen

location_facility:
Rouen University Hospital
Caen University Hospital

intervention_type: Other


title: The Importance of Metabolomics in Assessing the Quality of Kidney Transplants Retained on a LifePort® Perfusion Machine Before Renal Transplantation

acronym: RENALIFE

summary: When the kidneys are perfused on perfusion machines before transplantation, the resistance parameters as well as the histological score on the pre-implantation biopsy participate in the evaluation of the quality of the graft. The metabolomic profile of the infusion fluid could provide additional evidence.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Tours

location_facility:
Urology CHRU-TOURS
CHR-ORLEANS Service d'Urologie


title: A Phase II Multicentric Trial to Assess Efficacy and Toxicity of Imatinib in Adult Patients With Metastatic Ocular Melanoma

acronym: O-Mel-Inib

summary: The scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic ocular melanoma patients.

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Hospitalier Regional Universitaire


title: SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0

acronym: SBRT-NSCLC

summary:
The purpose of this study is to evaluate local disease control after 2 years in patients with non-metastatic, non-operated non-small-cell lung cancer treated by radiotherapy.

Eligible patients will be recruited and registered consecutively (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 4 years.

The number of patients required in this multicentric prospective study is 120:

20 patients in the SBRT-1 arm (cyberknife),
80 patients in the SBRT-2 arm (linear accelerator-based)
20 patients in the conformational radiotherapy arm.

This is a prospective, multicentric, non comparative and non randomized study.

design_allocation: Non-Randomized

ReferenceCitation: Noel G, Bollet MA, Noel S, Feuvret L, Boisserie G, Tep B, Delattre JY, Baillet F, Ambroise Valery C, Cornu P, Mazeron JJ. Linac stereotactic radiosurgery: an effective and safe treatment for elderly patients with brain metastases. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1555-61. Epub 2005 Jul 18.

ReferenceCitation: Kaplan EL., MP. Nonparametric estimation from incomplete observations. 1958. J Am Stat Assoc 1958; 53:457-481

ReferenceCitation: Pommier P. Modélisation spatiale et médico-économique des thérapeutiques innovantes : à propos du projet français ETOILE d'hadronthérapie par ions carbone. Thèse de Science en économie de la santé ; juin 2005

ReferenceCitation: Pommier P, Ndiaga Gueye N, Buron C, Meyroneinc S. Modélisation du coût de l'innovation thérapeutique pour l'aide à la décision. Application à la radiothérapie par ions carbone (projet ETOILE). Santé et systémique 2007 ; 10 : 217-31

ReferenceCitation: Evaluation de la radiothérapie fractionnée en condition stéréotaxiques des métastases cérébrales, STIC 2005

ReferenceCitation: Tschung Sibley G. Radiotherapy for patient with medically inoperable stage I non-small cell lung cancer smaller doses and higher doses - a review. Cancer 2003;41:1-11

ReferenceCitation: Timmerman R, Papiez L, McGarry R, Likes L, DesRosiers C, Frost S, Williams M. Extracranial stereotactic radioablation: results of a phase I study in medically inoperable stage I non-small cell lung cancer. Chest. 2003 Nov;124(5):1946-55.

ReferenceCitation: McGarry RC, Papiez L, Williams M, Whitford T, Timmerman RD. Stereotactic body radiation therapy of early-stage non-small-cell lung carcinoma: phase I study. Int J Radiat Oncol Biol Phys. 2005 Nov 15;63(4):1010-5. Epub 2005 Aug 22.

ReferenceCitation: Whyte RI, Crownover R, Murphy MJ, Martin DP, Rice TW, DeCamp MM Jr, Rodebaugh R, Weinhous MS, Le QT. Stereotactic radiosurgery for lung tumors: preliminary report of a phase I trial. Ann Thorac Surg. 2003 Apr;75(4):1097-101.

ReferenceCitation: Xia T, Li H, Sun Q, Wang Y, Fan N, Yu Y, Li P, Chang JY. Promising clinical outcome of stereotactic body radiation therapy for patients with inoperable Stage I/II non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):117-25. Epub 2006 Jun 9.

ReferenceCitation: Nagata Y, Takayama K, Matsuo Y, Norihisa Y, Mizowaki T, Sakamoto T, Sakamoto M, Mitsumori M, Shibuya K, Araki N, Yano S, Hiraoka M. Clinical outcomes of a phase I/II study of 48 Gy of stereotactic body radiotherapy in 4 fractions for primary lung cancer using a stereotactic body frame. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1427-31. Epub 2005 Sep 19.

ReferenceCitation: Onishi H, Araki T, Shirato H, Nagata Y, Hiraoka M, Gomi K, Yamashita T, Niibe Y, Karasawa K, Hayakawa K, Takai Y, Kimura T, Hirokawa Y, Takeda A, Ouchi A, Hareyama M, Kokubo M, Hara R, Itami J, Yamada K. Stereotactic hypofractionated high-dose irradiation for stage I nonsmall cell lung carcinoma: clinical outcomes in 245 subjects in a Japanese multiinstitutional study. Cancer. 2004 Oct 1;101(7):1623-31.

ReferenceCitation: Hof H, Herfarth KK, Münter M, Hoess A, Motsch J, Wannenmacher M, Debus J J. Stereotactic single-dose radiotherapy of stage I non-small-cell lung cancer (NSCLC). Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):335-41.

ReferenceCitation: Uematsu M, Shioda A, Suda A, Fukui T, Ozeki Y, Hama Y, Wong JR, Kusano S. Computed tomography-guided frameless stereotactic radiotherapy for stage I non-small cell lung cancer: a 5-year experience. Int J Radiat Oncol Biol Phys. 2001 Nov 1;51(3):666-70.

ReferenceCitation: Fukumoto S, Shirato H, Shimzu S, Ogura S, Onimaru R, Kitamura K, Yamazaki K, Miyasaka K, Nishimura M, Dosaka-Akita H. Small-volume image-guided radiotherapy using hypofractionated, coplanar, and noncoplanar multiple fields for patients with inoperable Stage I nonsmall cell lung carcinomas. Cancer. 2002 Oct 1;95(7):1546-53.

ReferenceCitation: Lax I, Blomgren H, Näslund I, Svanström R. Stereotactic radiotherapy of malignancies in the abdomen. Methodological aspects. Acta Oncol. 1994;33(6):677-83.

ReferenceCitation: Blomgren H, Lax I, Näslund I, Svanström R. Stereotactic high dose fraction radiation therapy of extracranial tumors using an accelerator. Clinical experience of the first thirty-one patients. Acta Oncol. 1995;34(6):861-70.

ReferenceCitation: Timmerman R, Lohr F. Normal tissue Dose Constraints applied in lung stereotactic body radiation therapy. In Stereotactic Body Radiation Therapy, Pages 29-37; B.D. Kavanagh, R.D. Timmerman. Edts Lippicott Williams WilkinsSchemper M, Smith TL. A note on quantifying follow-up in studies of failure time. Control Clin Trials 1996; 17(4):343-346.

ReferenceCitation: Krol AD, Aussems P, Noordijk EM, Hermans J, Leer JW. Local irradiation alone for peripheral stage I lung cancer: could we omit the elective regional nodal irradiation? Int J Radiat Oncol Biol Phys. 1996 Jan 15;34(2):297-302. Review.

ReferenceCitation: Gauden SJ, Tripcony L. The curative treatment by radiation therapy alone of Stage I non-small cell lung cancer in a geriatric population. Lung Cancer. 2001 Apr;32(1):71-9.

ReferenceCitation: Morita K, Fuwa N, Suzuki Y, Nishio M, Sakai K, Tamaki Y, Niibe H, Chujo M, Wada S, Sugawara T, Kita M. Radical radiotherapy for medically inoperable non-small cell lung cancer in clinical stage I: a retrospective analysis of 149 patients. Radiother Oncol. 1997 Jan;42(1):31-6.

ReferenceCitation: Sirzén F, Kjellén E, Sörenson S, Cavallin-Ståhl E. A systematic overview of radiation therapy effects in non-small cell lung cancer. Acta Oncol. 2003;42(5-6):493-515. Review.

ReferenceCitation: Bradley JD, Wahab S, Lockett MA, Perez CA, Purdy JA. Elective nodal failures are uncommon in medically inoperable patients with Stage I non-small-cell lung carcinoma treated with limited radiotherapy fields. Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):342-7.

lead_sponsor: Centre Leon Berard

location_facility:
Centre Antoine Lacassagne
Centre Alexis Vautrin
Centre Oscar Lambret
Hôpital Tenon
Centre Georges François Leclerc
Centre René Gauducheau
Centre Leon Berard
Centre Val d'Aurelle Paul Lamarque
CHLS

intervention_type: Radiation


acronym: GASTRIM

summary:
Oral antiplatelet therapy is a key treatment of the STEMI (ST elevation myocardial infarction). Delayed action isn't suitable and has to be elucidated. If a delayed gastric emptying time is observed during STEMI, limiting the use of morphine and encourage the use of prokinetic agents can be a first answer to optimize coronary angioplasty environment.

Investigators propose a study to assess the gastric emptying times at the acute phase of myocardial infarction using a validated paracetamol absorption test. The STEMI group will be compared to in one hand, itself with measures performed 72 hours±12h after the event onset; and on the other hand, to a stable patient group referred for angioplasty for angina or non-ST-segment elevation myocardial infarction (NSTEMI). For STEMI group and stable patient group, the delay of apparition of Prasugrel or Ticagrelor efficacy will be determined by VerifyNow® test and correlated to gastric emptying times.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - Hôpital du Haut Lévèque


title: French Multicenter Study Assessing Angioplasty With Taxus Drug Eluting Stent in Unprotected Left Main Coronary Artery Associated to Other Coronary Lesions or Not

summary: The purpose of this study is to determine whether percutaneous coronary angioplasty with Taxus drug eluting stent is safe and effective in the treatment of unprotected left main coronary artery disease associated to other coronary lesions or not.

lead_sponsor: French Cardiology Society

location_facility: Institut Hospitalier Jacques Cartier-ICPS


title: ESCORT-HU : European Sickle Cell Disease Cohort - Hydroxyurea

acronym: ESCORT-HU

summary: In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in patients with Sickle Cell Disease.

ReferenceCitation: de Montalembert M, Voskaridou E, Oevermann L, Cannas G, Habibi A, Loko G, Joseph L, Colombatti R, Bartolucci P, Brousse V, Galactéros F; All ESCORT HU Investigators. Real-Life experience with hydroxyurea in patients with sickle cell disease: Results from the prospective ESCORT-HU cohort study. Am J Hematol. 2021 Oct 1;96(10):1223-1231. doi: 10.1002/ajh.26286. Epub 2021 Jul 23.

name: Reference Centre for Sickle Cell Disease, Department of General Pediatrics and Pediatric Infectious Diseases Necker‐Enfants malades Hospital, Assistance Publique‐Hôpitaux de Paris (AP‐HP)  Paris France

family: de Montalembert

full_name: Mariane de Montalembert

given: Mariane

name: Centre of Excellence in Rare Hematological Disease‐Hemoglobinopathies, Laiko General Hospital  Athens Greece

family: Voskaridou

full_name: Ersi Voskaridou

given: Ersi

name: Department of Pediatric Oncology & Hematology Charité University Medicine, Berlin and Berlin Institute of Health  Berlin Germany

family: Oevermann

full_name: Lena Oevermann

given: Lena

name: Hospices Civils de Lyon, Hôpital Edouard Herriot, Médecine Interne, Centre de Référence Constitutif: Syndromes Drépanocytaires Majeurs, Thalassémies et Autres Pathologies Rares du Globule Rouge et de l'Erythropoïèse  Lyon France

family: Cannas

full_name: Giovanna Cannas

given: Giovanna

name: Sickle Cell Referral Center, Department of Internal Medicine Henri‐Mondor University Hospital‐UPEC, AP‐HP  Créteil France

family: Habibi

full_name: Anoosha Habibi

given: Anoosha

name: Centre hospitalier de la Martinique  Fort‐de‐France Martinique France

family: Loko

full_name: Gylna Loko

given: Gylna

name: Biotherapy Department Necker Children's Hospital, Assistance Publique‐Hôpitaux de Paris  Paris France

family: Joseph

full_name: Laure Joseph

given: Laure

name: Department of Woman's and Child's Health University of Padua  Padua Italy

family: Colombatti

full_name: Raffaella Colombatti

given: Raffaella

family: Bartolucci

full_name: Pablo Bartolucci

given: Pablo

family: Brousse

full_name: Valentine Brousse

given: Valentine

family: Galactéros

full_name: Frédéric Galactéros

given: Frédéric

journal_name: American Journal of Hematology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Real‐Life experience with hydroxyurea in patients with sickle cell disease: Results from the prospective ESCORT‐HU cohort study

lead_sponsor: ADDMEDICA SASA

location_country:
Italy
Guadeloupe
French Guiana
France
Greece
Martinique
Germany

location_facility: Centre hospitalier intercommunal de Créteil

location_facility: Hôpital Louis Mourier; service de pédiatrie

location_facility: Hôpital Necker enfants, maladies infectieuses et tropicales

location_facility: Centre Hospitalier Intercommunal André Grégoire

location_facility: Hôpital Henri Mondor, centre de la Drépanocytose

location_facility: Azienda Ospedaliera Universitaria Integrata (AOUI Verona)

location_facility: Hôpital Robert Debré, immunologie-hématologie pédiatrique

location_facility: Azienda Ospedaliera-University of Padova

location_facility: Centre Hospitalier Robert Ballanger, pédiatrie et néonatalogie

location_facility: Hôpital de la Conception, médecine interne

location_facility: Institut Universitaire du cancer; médecine interne

location_facility: Centre Hospitalier Delafontaine, médecine interne

location_facility: Centre Hospitalier Delafontaine, pédiatrie

location_facility: Centre Hospitalier de Gonesse, pédiatrie

location_facility: Institut d'Hématologie et d'Oncologie Pédiatrique

location_facility: Hôpital Necker; maladies infectieuses et tropicales

location_facility: Centre Hospitalier de Gonesse, médecine interne


title: Analysis of the Most Common Major Intraoperative Complications During Video-assisted Thoracoscopic Surgery (VATS) Anatomical Resections - On Behalf of MITIG-ESTS

summary: This study investigates the most common major complications that result in unplanned additional surgery in patients undergoing vats anatomical resections. Several high-volume European centres participate. The purpose is to quantify these major complications, discuss the steps that can be taken to prevent these events, how they can be dealt with, be it by vats or conversion

time_perspective: Retrospective

lead_sponsor: University Hospital, Gasthuisberg

location_country: Italy Austria Switzerland Netherlands France Poland Spain Denmark Germany

location_facility: Department of Visceral, Transplant and Thoracic Surgery, Innsbruck University Hospital

location_facility: Department of Cardiothoracic Surgery, Rigshospitalet

location_facility: Division of Thoracic Surgery, Ospedali Riuniti Ancona

location_facility: Karol Marcinkowski University of Med Sciences, Department of Thoracic Surgery

location_facility: Thoracic Department, Institut Mutualiste Montsouris


title: adaptatiVe Endovascular Strategy to the CloT MRI in Large Intracranial Vessel Occlusion

acronym: VECTOR

summary:
In the VECTOR trial, the aim is to analyze, in case of SVS+ occlusions, a first line Embotrap II added to CA combined strategy compare to CA alone strategy.

Many practitioners are convinced that a first line strategy with CA alone is easy, safe, rapid and efficient. Maybe, after two, three, four ... passes and with the secondary help of a combined strategy, a high rate of eTICI 2b/3 could be reached with a CA first line strategy. But this could go with a higher number of passes, a waste of time and a suboptimal angiographic results (eTICI 2b) due to distal emboli, especially in case of friable, non-well organized, red blood cell rich (RBC) i.e. SVS + thrombi (25-28). This could, be related to worst clinical outcome at 3 months. VECTOR asks a relevant question: Do the invetigators have to add the use of an Embotrap II or III to the CA, from the first passes, in case of SVS+ clots?

lead_sponsor: Nantes University Hospital

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

intervention_type: Procedure

status_simplified: Ongoing


title: Predictive Signature of Benralizumab Response

acronym: BENRAPRED

summary:
The objective of the study is to establish the predictive value of early blood gene expression signature of Benralizumab response associated with a significant reduction of the number of exacerbations in treated severe asthmatic patients.

This trial is a French, multicenter and no-randomized trial. Patients enrolled will be clinically followed for 16 months (the treatment period: 12 months and 1 month follow-up; 6 clinical visit on site and in phone call at 13 months)

primary_purpose: Other

ipd_sharing: Undecided

location_facility: Assistance Publique des Hôpitaux de Marseille


acronym: PREFIPS

location_facility:
Cochin Hospital
La Pitié Salpêtrière Hospital

type: EudraCT Number

source: euctr

title: Prevention of Postoperative Pancreatic Fistula by SOMATOSTATIN Compared to OCTREOTIDE: Prospective, Randomized, Controlled Study

summary: The purpose of this study is to determine whether somatostatin is more effective that octreotide in the prevention of post-pancreatectomy pancreatic fistula


title: Validation of Radio-induced Damage Biomarkers : BIOM-DRI Study

acronym: BIOM-DRI

summary: The aim of this study is to confirm in humans the relevance and the kinetics of radio-induced bio-markers in plasma and urines, previously described at the preclinical stage.

primary_purpose: Prevention

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Determination of Circulating miRNAs as Diagnostic Markers of Lung Disease in Cystic Fibrosis

acronym: MIRDIAMUCO

summary: The aim of our study is to assess miRNAs expression profiles in the circuling blood of patients with cystic fibrosis and highlight "signatures" that could reflect the pulmonary status of patients

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Montpellier

location_facility:
Montpellier University Hospital
Necker Hospital


title: Home Telemonitoring of Resting Spontaneous Breathing in Severe Asthma: a Pilot Study

acronym: AsthmaDom

summary: Asthma exacerbations account for a significant morbidity and disproportionate health care costs. However, there is no currently available biomarker or lung function parameter that can accurately predict the risk of future exacerbations. The current work aims at evaluating the resting ventilatory flow by applying a new technique called anharmonic morphological analysis of the respiratory signals (AMARS). We hypothesize that monitoring AMARS is potentially able to detect an increased risk of asthma exacerbations.

location_facility:
Bordeaux University Hospital
Grenoble University Hospital


title: Efficacy and Safety of Pitolisant (BF2.649) in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway Pressure, But Still Complaining of Excessive Daytime Sleepiness

acronym: HAROSA IV

summary:
The first objective of this study is to demonstrate the efficacy and safety of pitolisant given at 10, 20, or 40 mg per day versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by nCPAP but still complaining of EDS.

The secondary objectives of the study include assessing the long-term tolerance as well as the maintenance of efficacy of pitolisant given at 10, 20 or 40 mg per day during 39 weeks of Open Label Extension period.

status: Withdrawn

lead_sponsor: Bioprojet

location_facility: Hôpital Gui de Chauliac, CHU Montpellier, Unité des Troubles du Sommeil et de l'Eveil

location_facility: Laboratoire du sommeil Clinique de Physiologie, Sommeil et Exercice Pôle Thorax et Vaisseaux CHU de Grenoble


title: Prediction of Pain During Old People Care Measured by Skin Conductance

acronym: DOLOAGE

summary:
The purpose of the project is to validate the use of Pain Monitor™ device, not invasive and simple of employment, for old people able to answer to a digital scale of pain intensity.

The main objective is to develop and to validate a model of prediction of the pain in old subject at the time of the care, using the measure of variation of the skin conductance.

lead_sponsor: Hopital Foch

location_facility:
Hopital Foch
Maison Médicale Jeanne Garnier


title: Evaluation de l'Impact d'un Mode de supplémentation en Vitamine D (Dose séquentielle vs Dose Quotidienne) Sur l'Incidence de l'Hypercalciurie Chez Des Enfants Des départements du Gard et de l'Hérault agés de 2 à 6 Ans. Etude contrôlée randomisée en 2 Groupes parallèles

acronym: DonneDVit

summary: Recommendations for vitamin D supplementation for children between 2 and 6 years offer strong sequential doses of vitamin D: 2 times 100 000 units in spaced winter period of 3 months. Data from the literature show a further increase in the incidence of oxalo-calcium stones in children and adolescents associated with hypercalciuria with training Randall plates, essential step lithogenesis calcium oxalate. Knowing the links between vitamin D and urinary calcium excretion, these data lead to the question of increased sensitivity in some children with vitamin D, sensitivity could explain these situations with hypercalciuria increase the gallstone risk. This increased sensitivity to vitamin D may unmask particularly if inputs of high doses of vitamin responsible then a transient hypercalciuria with development of microcrystals.


title: Ejaculation of Spinal Cord Patient: Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters

acronym: EDGE

summary: The objective of this research is to study the sphincter activity during ejaculation in patients with spinal cord injury in order to detect an ejaculatory dyssynergia. For this purpose, using a catheter the protocol plans to measure the sphincter pressures during ejaculation. Moreover, cardiovascular parameters will be measured continuously during the ejaculatory test.

lead_sponsor: Lille Catholic University

location_facility:
Centre Calvé
Centre Bouffard Vercelli


status: Active, not recruiting

lead_sponsor: UNICANCER

acronym: TACTIK

location_facility:
Centre Léon Berard
Stéphane CULINE
ICO-Site Paul Papin
CHD Vendée
ICO-Site René Gauducheau

title: Personalized Treatment of Metastatic Castrate Resistant Prostate Cancer Patients According to Circulating Tumor Cells Kinetic During Chemotherapy: A GETUG-AFU 28 Study

summary:
This study compares the biological activity of cabazitaxel (6 cycles) to that of docetaxel (6 cycles) in metastatic castrate-resistant prostate cancer (mCRPC) patients with docetaxel resistant mCRPC defined as ≥5 circulating tumor cells (CTCs) / 7.5 mL after 2 cycles of docetaxel.

Patients with docetaxel resistant metastatic castration-resistant prostate cancer (mCRPC) based on circulating tumor cell (CTC) enumeration (patients with ≥5 CTCs / 7.5 mL before docetaxel chemotherapy and after 2 cycles of docetaxel) will receive either 6 additional cycles of docetaxel or 6 additional cycles of cabazitaxel after randomisation.

A cohort of patients with docetaxel sensitive metastatic castration-resistant prostate cancer (mCRPC) based on circulating tumor cell (CTC) enumeration (patients ≥5 CTCs / 7.5 mL before docetaxel chemotherapy and <5 CTCs / 7.5 mL after 2 cycles of docetaxel) will receive 6 additional cycles of docetaxel.


title: Medical and Economical Evaluation of Contrast-enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases

summary: Bevacizumab, an anti-angiogenic agent, plus fluorouracil based chemotherapy is considered a new standard for the treatment of metastatic colorectal cancer. Contrast-enhanced ultrasound with gas-encapsulated microbubbles can be used to assess tumour vascularity, particularly hepatic metastases, and may become a useful tool for monitoring anti-angiogenic therapies. The aim of this prospective, multicenter, non-randomized study is to evaluate the usefulness of hepatic contrast-enhanced ultrasound to predict response to bevacizumab based chemotherapy in patient with metastatic colorectal cancer. The primary objective of this study is to compare the functional vascular changes related to bevacizumab based chemotherapy and evaluated by hepatic contrast-enhanced ultrasound with classic RECIST criteria. The secondary objectives are to do a characterization of the pharmacokinetic of bevacizumab, to explore the pharmacodynamic effects of bevacizumab on functional vascular changes of hepatic metastases evaluated by hepatic contrast-enhanced ultrasound and to analyze the possible relationships between treatment efficacy or toxicity and constitutional gene polymorphisms linked to the bevacizumab.

ReferenceCitation: Bleuzen A, Huang C, Olar M, Tchuenbou J, Tranquart F. Diagnostic accuracy of contrast-enhanced ultrasound in focal lesions of the liver using cadence contrast pulse sequencing. Ultraschall Med. 2006 Feb;27(1):40-8.

ReferenceCitation: Forsberg F, Ro RJ, Potoczek M, Liu JB, Merritt CR, James KM, Dicker AP, Nazarian LN. Assessment of angiogenesis: implications for ultrasound imaging. Ultrasonics. 2004 Apr;42(1-9):325-30.

ReferenceCitation: Broillet A, Hantson J, Ruegg C, Messager T, Schneider M. Assessment of microvascular perfusion changes in a rat breast tumor model using SonoVue to monitor the effects of different anti-angiogenic therapies. Acad Radiol. 2005 May;12 Suppl 1:S28-33.

ReferenceCitation: Niermann KJ, Fleischer AC, Donnelly EF, Schueneman AJ, Geng L, Hallahan DE. Sonographic depiction of changes of tumor vascularity in response to various therapies. Ultrasound Q. 2005 Jun;21(2):61-7; quiz 149, 153-4.

ReferenceCitation: Preda A, Novikov V, Möglich M, Turetschek K, Shames DM, Brasch RC, Cavagna FM, Roberts TP. MRI monitoring of Avastin antiangiogenesis therapy using B22956/1, a new blood pool contrast agent, in an experimental model of human cancer. J Magn Reson Imaging. 2004 Nov;20(5):865-73.

ReferenceCitation: Gerber HP, Ferrara N. Pharmacology and pharmacodynamics of bevacizumab as monotherapy or in combination with cytotoxic therapy in preclinical studies. Cancer Res. 2005 Feb 1;65(3):671-80.

ReferenceCitation: Zondor SD, Medina PJ. Bevacizumab: an angiogenesis inhibitor with efficacy in colorectal and other malignancies. Ann Pharmacother. 2004 Jul-Aug;38(7-8):1258-64. Epub 2004 Jun 8. Review.

ReferenceCitation: Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42.

ReferenceCitation: Jary M, Lecomte T, Bouché O, Kim S, Dobi E, Queiroz L, Ghiringhelli F, Etienne H, Léger J, Godet Y, Balland J, Lakkis Z, Adotevi O, Bonnetain F, Borg C, Vernerey D. Prognostic value of baseline seric Syndecan-1 in initially unresectable metastatic colorectal cancer patients: a simple biological score. Int J Cancer. 2016 Nov 15;139(10):2325-35. doi: 10.1002/ijc.30367. Epub 2016 Aug 13.

name: Department of Medical Oncology; University Hospital; Besançon France

name: INSERM, Unit 1098, University of Bourgogne- Franche Comté; Besançon France

name: Clinical Investigation Center 1431, EFS Bourgogne-Franche Comté; Besançon France

family: Jary

full_name: Marine Jary

given: Marine

name: CNRS, Unit 7292, University François-Rabelais; Tours France

name: Department of HepatoGastroenterology and Digestive Oncology; University Hospital; Tours France

family: Lecomte

full_name: Thierry Lecomte

given: Thierry

name: Department of HepatoGastroenterology and Digestive Oncology; University Hospital Robert Debré; Reims France

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Kim

full_name: Stefano Kim

given: Stefano

family: Dobi

full_name: Erion Dobi

given: Erion

family: Queiroz

full_name: Lise Queiroz

given: Lise

name: Department of Medical Oncology; Leclerc Anticancer Center; Dijon France

family: Ghiringhelli

full_name: Francois Ghiringhelli

given: Francois

name: Department of Gastroenterology; University Hospital; Besançon France

family: Etienne

full_name: Hélène Etienne

given: Hélène

name: INSERM, Clinical Investigational Center CIC 1415; Tours France

family: Léger

full_name: Julie Léger

given: Julie

family: Godet

full_name: Yann Godet

given: Yann

family: Balland

full_name: Jérémy Balland

given: Jérémy

name: Department of Digestive Surgery and Liver Transplantation; University Hospital; Besançon France

family: Lakkis

full_name: Zaher Lakkis

given: Zaher

family: Adotevi

full_name: Olivier Adotevi

name: Methodological and Quality of Life in Oncology Unit; EA 3181, University Hospital; Besançon France

family: Borg

full_name: Christophe Borg

given: Christophe

family: Vernerey

full_name: Dewi Vernerey

given: Dewi

journal_name: International Journal of Cancer

location_facility: Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris


title: Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies

acronym: ImmRubVac

summary: The aim of the research is to study humoral and cellular immunity in pregnant women for who the level of rubella virus antibodies is weakly positive, equivocal or negative with the usual laboratory technique.

location_facility:
Hôpital Foch
Hôpital Antoine-Béclère

intervention_type: Biological


title: Perceived Impact of Art Therapy in Patients With Cystic Fibrosis (Adolescents, Adults and Transplanted Not Transplanted) and in Professional Interdisciplinary Teams Taking Care of Them.

acronym: MUCO-ART-PLUS

summary:
Cystic fibrosis is so far a disease whose treatment remains essentially symptomatic care teams perceive the boundaries of a support mainly focused on drug treatments. The patient had no other choice but to learn to live with their disease, the goal is to make every effort so that tames the disease while maintaining high self-esteem that gives meaning to his life, allowing, among other things, a good grip of treatment.

Through this research we hope to encourage the integration of art therapy in the course of care of cystic fibrosis patients, from children to adults before and after transplantation, in connection with the patient education and counseling

location_facility:
Nantes University Hospital
Foch Hospital


summary: The objective of the study is to estimate the reliability of the determination of the cardiac output measured by the ECOM™ device. This study will be performed with the latest version of the software which should give better results than those published previously. Two techniques of measure of the cardiac output will be compared: the reference measure by trans-esophageal echography and the bioimpedance used by the ECOM™. monitor.

location_facility:
Centre Chirurgical Marie-Lannelongue
Institut Mutualiste Montsouris


acronym: OSCILLOREVERS

summary:
Limitation of expiratory flows is considered as the main determiner of dynamic distension and dyspnoea in chronic obstructive pulmonary disease (COPD). The analysis of proximal and distal resistances should allow to better appreciate the functional impact.

This study should also allow to specify the best parameters in respiratory functional explorations useful for the follow-up in COPD and to specify the relevance of functional indications other than the forced expiration volume at 1 second (FEV1) or the functional residual capacity (FRC) to estimate in a more relevant way the clinical improve with the increase of the therapeutic load (increase of posology, association of two bronchodilatators, addition of an anti-inflammatory drug, thus etc…) at already handled patients suffering from a persistent dyspnoea insufficiently relieved.

location_facility:
Hôpital Foch
CHRU


title: Chronic Neuropathic Pain After Lung Surgery: Prevalence and Predictive Factors

acronym: DOLORPOUMON

summary: Chronic post-thoracotomy pain is the most common long-term complication that occurs after a thoracotomy with a reported incidence of up to 80%. Surgical approach as well as other factors (genetic, psychological) could have a major and independent role in the development of the post operative pain.The main objective of this study is to identify genetic and psychological profile (cognitive and emotional) of patients who develop chronic pain after lung surgery.

location_facility:
Hopital Foch
Institut Mutualiste Montsouris


title: Cervical Arthroplasty "Fixed Core" Versus "Movable Core": A Controlled Prospective Study, Clinical and Radiological Impact in the Medium Term

acronym: DISC-C

summary:
Nowadays, there is no clinical and radiological study comparing two different types of mobile implants in patients requiring surgical treatment for symptomatic cervical disc disease. Thus, the choice of the ideal implant remains uncertain.

The goal of this work is to compare the impact of two types of mobile implants in height drives, solicitation facets, positioning and collection of prostheses within the intervertebral spaces.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
Hôpital Bretonneau, CHU DE TOURS
CHR d'ORLEANS


title: Pilot Study Evaluating the Oncogramme: Analysis of Response to Induction Treatment of Patients With Breast or Ovarian Cancer.

acronym: ONCO S-O

summary:
The choice of treatments for cancers by systemic way - chemotherapy, hormone therapy and targeted therapies - is currently defined by criteria for population groups and not to an individual. These expensive treatments - in financial terms and quality of life - will be effective for some and administered unnecessarily for other because there is no predictive test of response for a given individual.

For breast cancer, the usual treatment includes the first surgery and adjuvant therapies (chemotherapy, hormonal therapy ...) whose effectiveness will be assessed after many years as the occurrence or not of a recurrence or metastases.

These systemic treatments can also be administered before surgery to reduce the tumor volume and secondarily allow less mutilating surgery: it is the principle of treatment neo adjuvant. In this case, the efficiency will be evaluated more quickly.

In practice, a patient with breast cancer suspicion has a biopsy which confirms the diagnosis and defined the parameters (hormone receptors, cytological grade, receptor monoclonal antibodies ...) that guide to the most appropriate type of treatment.

Tumor size is evaluated in neo adjuvant pre-treatment by imaging: mammography, ultrasound and MRI.

At the end of this medication, the evaluation of the response is achieved by radiology and surgery.

Pathological examination evaluates and precise response by the criteria of Chevallier and / or Sataloff. An ex vivo test for predicting the response of cells to different chemotherapy regimens, the oncogramme, was developed by Oncomedics, a young company whose technology is derived from the University of Limoges.

Clinical response and / or histopathological could be compared in a reasonable time (2-6 months), the results of the oncogramme proposed by Oncomedics whether the efficiency obtained in vivo is that predicted by the ex vivo test.

It is the same in the metastatic setting when there is an available target for biopsy and assessment of response.

The management of ovarian cancer in advanced stages can also benefit from a radiological and histopathological evaluation strategy before and after systemic treatment to compare the in vivo results with those predicted by ex vivo by Oncomedics.

lead_sponsor: University Hospital, Limoges


title: Determinants of Cerebral Oxygenation and Perfusion in SCA Children Based on Combined ASL MRI, NIRS and Hemorheological Investigation

summary: The aim of this study is to evaluate determinants of cerebral oxygenation and perfusion at the microcirculatory level in children with sickle cell anemia (SCA) using combined novel investigational tools: Arterial Spin Labeling (ASL) perfusion MR (Magnetic Resonnance) imaging, brain Near Infra-Red Spectroscopy (NIRS) and red blood cell (RBC) rheological properties.

lead_sponsor: Imagine Institute

location_facility:
Centre Hospitalier Intercommunal
Necker - Enfants Malades hospital


title: Pilot Study of Lung Transplantation After Ex-Vivo Lung Reconditioning

acronym: ExVivo

summary:
Only about 15% of the potential candidates for lung donation are considered suitable for transplantation. Thus, a strategy that could improve the quality and precision of assessment of nonacceptable donor lungs could have a major impact on reducing waiting time and mortality while on the list.

A new method for ex vivo lung perfusion (EVLP) has been developed recently by Steen and colleagues to assess the quality of lungs from a non-heart-beating donor. The method can also be used to recondition "marginal" and nonacceptable donor lungs.

After harvesting, the lungs were perfused ex vivo with Steen Solution, an extracellular matrix with high colloid osmotic pressure. A membrane oxygenator connected to the circuit received gas from a mixture of nitrogen and carbon dioxide, maintaining a normal mixed venous blood gas level in the perfusate. The lungs were gradually rewarmed, reperfused, and ventilated for evaluation through analyses of oxygenation capacity, pulmonary vascular resistance (PVR), lung compliance (LC), and biopsy.

location_facility:
Centre chirugical Marie Lannelongue
Hopital Foch


title: Functional Evaluation of Distal Airways by Forced Oscillations: Diagnosis Help in Bronchiolitis Obliterans Syndrome in Post Bone Marrow Transplantation

acronym: OSCILLOMOELL

summary: A study to evaluate the role of forced oscillations in diagnosis of bronchiolitis obliterans syndrome in patients after bone marrow transplantation. The force oscillations technique will be compared with classical spirometry.

ReferenceCitation: Williams KM, Chien JW, Gladwin MT, Pavletic SZ. Bronchiolitis obliterans after allogeneic hematopoietic stem cell transplantation. JAMA. 2009 Jul 15;302(3):306-14. doi: 10.1001/jama.2009.1018.

ReferenceCitation: Soubani AO, Uberti JP. Bronchiolitis obliterans following haematopoietic stem cell transplantation. Eur Respir J. 2007 May;29(5):1007-19. Review.

ReferenceCitation: Chien JW, Martin PJ, Gooley TA, Flowers ME, Heckbert SR, Nichols WG, Clark JG. Airflow obstruction after myeloablative allogeneic hematopoietic stem cell transplantation. Am J Respir Crit Care Med. 2003 Jul 15;168(2):208-14. Epub 2003 Mar 20.

ReferenceCitation: Bergeron A, Belle A, Chevret S, Ribaud P, Devergie A, Esperou H, Ades L, Gluckman E, Socié G, Tazi A. Combined inhaled steroids and bronchodilatators in obstructive airway disease after allogeneic stem cell transplantation. Bone Marrow Transplant. 2007 May;39(9):547-53. Epub 2007 Mar 12.

ReferenceCitation: Gunn ML, Godwin JD, Kanne JP, Flowers ME, Chien JW. High-resolution CT findings of bronchiolitis obliterans syndrome after hematopoietic stem cell transplantation. J Thorac Imaging. 2008 Nov;23(4):244-50. doi: 10.1097/RTI.0b013e3181809df0.

ReferenceCitation: Martin PJ, Weisdorf D, Przepiorka D, Hirschfeld S, Farrell A, Rizzo JD, Foley R, Socie G, Carter S, Couriel D, Schultz KR, Flowers ME, Filipovich AH, Saliba R, Vogelsang GB, Pavletic SZ, Lee SJ; Design of Clinical Trials Working Group. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. Design of Clinical Trials Working Group report. Biol Blood Marrow Transplant. 2006 May;12(5):491-505.

ReferenceCitation: Garcia G, Perez T, Mahut B. [Lung function testing and assessment of distal airways in asthma]. Rev Mal Respir. 2009 Apr;26(4):395-406; quiz 479, 482. French.

ReferenceCitation: Bourdin A, Paganin F, Préfaut C, Kieseler D, Godard P, Chanez P. Nitrogen washout slope in poorly controlled asthma. Allergy. 2006 Jan;61(1):85-9.

ReferenceCitation: Oostveen E, MacLeod D, Lorino H, Farré R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. Review.

ReferenceCitation: Smith HJ, Reinhold P, Goldman MD. Forced Oscillation Technique and Impulse Oscillometry. Lung Function Testing: European Respiratory Society Monograph. Sheffield, England: European Respiratory Society; 2005:72-105

ReferenceCitation: Goldman MD. Clinical application of forced oscillation. Pulm Pharmacol Ther. 2001;14(5):341-50. Review.

ReferenceCitation: Hamakawa H, Sakai H, Takahashi A, Zhang J, Okamoto T, Satoda N, Aoyama A, Chen F, Fujinaga T, Shoji T, Bando T, Mishima M, Wada H, Date H. Forced oscillation technique as a non-invasive assessment for lung transplant recipients. Adv Exp Med Biol. 2010;662:293-8. doi: 10.1007/978-1-4419-1241-1_42.

ReferenceCitation: Faria AC, Lopes AJ, Jansen JM, Melo PL. Evaluating the forced oscillation technique in the detection of early smoking-induced respiratory changes. Biomed Eng Online. 2009 Sep 25;8:22. doi: 10.1186/1475-925X-8-22.

ReferenceCitation: Brochard L, Pelle G, de Palmas J, Brochard P, Carre A, Lorino H, Harf A. Density and frequency dependence of resistance in early airway obstruction. Am Rev Respir Dis. 1987 Mar;135(3):579-84.

ReferenceCitation: Skloot G, Goldman M, Fischler D, Goldman C, Schechter C, Levin S, Teirstein A. Respiratory symptoms and physiologic assessment of ironworkers at the World Trade Center disaster site. Chest. 2004 Apr;125(4):1248-55.

ReferenceCitation: Di Mango AM, Lopes AJ, Jansen JM, Melo PL. Changes in respiratory mechanics with increasing degrees of airway obstruction in COPD: detection by forced oscillation technique. Respir Med. 2006 Mar;100(3):399-410. Epub 2005 Aug 22.

ReferenceCitation: Kanda S, Fujimoto K, Komatsu Y, Yasuo M, Hanaoka M, Kubo K. Evaluation of respiratory impedance in asthma and COPD by an impulse oscillation system. Intern Med. 2010;49(1):23-30. Epub 2010 Jan 1.

ReferenceCitation: Cavalcanti JV, Lopes AJ, Jansen JM, Melo PL. Detection of changes in respiratory mechanics due to increasing degrees of airway obstruction in asthma by the forced oscillation technique. Respir Med. 2006 Dec;100(12):2207-19. Epub 2006 May 18.

ReferenceCitation: Kim CW, Kim JS, Park JW, Hong CS. Clinical applications of forced oscillation techniques (FOT) in patients with bronchial asthma. Korean J Intern Med. 2001 Jun;16(2):80-6.

ReferenceCitation: Kolsum U, Borrill Z, Roy K, Starkey C, Vestbo J, Houghton C, Singh D. Impulse oscillometry in COPD: identification of measurements related to airway obstruction, airway conductance and lung volumes. Respir Med. 2009 Jan;103(1):136-43. doi: 10.1016/j.rmed.2008.07.014. Epub 2008 Aug 28.

location_facility:
CHRU de Lille
Hopital Foch


title: A Study of Hemodynamic Changes Using Near Infra-red Spectrometry (NIRS) in Infantile Epilepsy Spasms

acronym: SPASMES-NIRS

summary:
This study will included 20 children presenting with epilepsy with spasms. It aims to offer these children, non invasively and without supplementary examinations, a recording of local and cerebral hemodynamic changes concomitant with an electroencephalographic recording during epileptic episodes. This will be carried out by combining optical imaging using near infra-red spectroscopy (NIRS) with electroencephalography (EEG), in a simultaneous high-resolution (HR) recording.

This study is among those based on multimodal analyses of epilepsy, combining methods of analysis of electrical activity (electrical imaging) and hemodynamics (optical imaging).

Surface electroencephalography (EEG) is a precious tool enabling the study of neuronal dysfunction from a functional point view. It is used in the routine follow-up of children with epilepsy. Optical imaging is a promising medical imaging technique. It uses light in the spectral regions of near infra-red as a source of radiation. It is quantitative, rapid, non invasive, and inoffensive which could easily be used at the child's bedside or in a clinical setting and can provide metabolic information about cerebral function.

This study is multidisciplinary, which calls upon the skills of neurophysiologists, biophysicists, and clinicians

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Amiens
Fondation Ophtalmologique Rothshild


title: Effect of the "Adjusted Vocal Expression" Method on the Satisfaction of Parturients About Their Childbirth (NaîtreEnchanté)

acronym: NaitreEnchan

summary:
To emit voluntarily sounds mastered during the childbirth is a practice found in certain cultures of country of Africa or Muslim or gypsy traditions. Today, because of the medical coverage and because of the childbirth in a hospital environment, this tradition is not anymore transmitted.

The emission of a sound vibration conjugated to a positive intention managed during the childbirth was experimented with around thirty mothers. In the term of this pilot study, most of the women expressed one felt very positive towards the new method, in particular when they compared it with a previous childbirth where this method was not used.

During these childbirths, the midwives also indicated a shortening of the working time.

The present study aim essentially is to confirm the positive effect of the method on the felt of the childbirth.

location_facility:
Maternité Catherine BARET de Pertuis
Hopital Foch


ReferenceCitation: Omar E, Wallon G, Bauer C, Axiotis G, Bouix C, Soubirou JL, Aubrun F. Evaluation of intravenous lidocaine in head and neck cancer surgery: study protocol for a randomized controlled trial. Trials. 2019 Apr 15;20(1):220. doi: 10.1186/s13063-019-3303-x.

apc_source: openAPC

family: Omar

full_name: Edris Omar

given: Edris

family: Wallon

full_name: Grégoire Wallon

given: Grégoire

family: Bauer

full_name: Christian Bauer

given: Christian

family: Axiotis

full_name: Grégory Axiotis

given: Grégory

family: Bouix

full_name: Cécile Bouix

given: Cécile

family: Soubirou

full_name: Jean-Luc Soubirou

given: Jean-Luc

family: Aubrun

full_name: Frédéric Aubrun

journal_name: Trials

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Hospices Civils de Lyon

acronym: ELICO

location_facility: Hospices Civils de Lyon / Hôpital de la Croix Rousse

title: Intravenous Lidocaine in Carcinologic ENT Surgery: A Randomized Controlled Trial for Evaluation of Opioid Saving Strategy and Chronic Post-surgical Pain

summary:
Lidocaine, local anesthetic used for more than five decades, is being intravenously administered aiming at managing pain in different types of surgeries with promising results. Opioid-induced hyperalgesia need to be considered in ear-nose-throat (ENT) surgery owing to the difficulty of locoregional anesthesia and high level of opioid consumption.

This randomized study aims to compare quality of perioperative analgesia after infusion of intravenous lidocaine during carcinological ENT surgery. The main purpose of this study is to evaluate morphine consumption during the 48 postoperative hours.

Others purposes are evaluation of peroperative remifentanil consumption, morphine consumption during the 24 postoperative hours, chronic post-surgical pain evaluated from 3 to 6 months after carcinologic ENT surgery, and incidence of side effects that can be attributed to lidocaine infusion.


acronym: THYMO B

summary: The investigators expect to better characterise B cell subpopulation and functional properties early after graft, to analyse effect of induction therapy (thymoglobulin versus basiliximab) on B cells, and to compare this B cell profiles with those obtained in our previous study in patients with chronic Antibody Mediated Rejection (cAMR)

lead_sponsor: University Hospital, Brest

location_facility:
Tours University Hospital
CHU Brest


title: Randomized Controlled Trial of Prevention of Fall-related Fractures and Other Injuries by Physical Exercise Among Community Dwelling Elderly Women

acronym: Ossébo

summary:
Primary objective: to evaluate the effectiveness of a fall prevention exercise program in preventing falls resulting in fractures and other physical traumas.

Secondary objectives:

to better understand the mechanisms by which physical exercise prevents falls and ensuing injuries (improvement in physical functional abilities, global physical activity level, general physical and psychological wellbeing and self-confidence).
to determine the individual factors associated with long-term adherence to the exercise program.

ReferenceCitation: Chang JT, Morton SC, Rubenstein LZ, Mojica WA, Maglione M, Suttorp MJ, Roth EA, Shekelle PG. Interventions for the prevention of falls in older adults: systematic review and meta-analysis of randomised clinical trials. BMJ. 2004 Mar 20;328(7441):680. Review.

ReferenceCitation: Buchner DM, Cress ME, de Lateur BJ, Esselman PC, Margherita AJ, Price R, Wagner EH. The effect of strength and endurance training on gait, balance, fall risk, and health services use in community-living older adults. J Gerontol A Biol Sci Med Sci. 1997 Jul;52(4):M218-24.

ReferenceCitation: Campbell AJ, Robertson MC, Gardner MM, Norton RN, Tilyard MW, Buchner DM. Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women. BMJ. 1997 Oct 25;315(7115):1065-9.

ReferenceCitation: Campbell AJ, Robertson MC, Gardner MM, Norton RN, Buchner DM. Falls prevention over 2 years: a randomized controlled trial in women 80 years and older. Age Ageing. 1999 Oct;28(6):513-8.

ReferenceCitation: Robertson MC, Devlin N, Gardner MM, Campbell AJ. Effectiveness and economic evaluation of a nurse delivered home exercise programme to prevent falls. 1: Randomised controlled trial. BMJ. 2001 Mar 24;322(7288):697-701.

ReferenceCitation: Lord SR, Castell S, Corcoran J, Dayhew J, Matters B, Shan A, Williams P. The effect of group exercise on physical functioning and falls in frail older people living in retirement villages: a randomized, controlled trial. J Am Geriatr Soc. 2003 Dec;51(12):1685-92.

ReferenceCitation: Barnett A, Smith B, Lord SR, Williams M, Baumand A. Community-based group exercise improves balance and reduces falls in at-risk older people: a randomised controlled trial. Age Ageing. 2003 Jul;32(4):407-14.

ReferenceCitation: Day L, Fildes B, Gordon I, Fitzharris M, Flamer H, Lord S. Randomised factorial trial of falls prevention among older people living in their own homes. BMJ. 2002 Jul 20;325(7356):128.

ReferenceCitation: Li F, Harmer P, Fisher KJ, McAuley E, Chaumeton N, Eckstrom E, Wilson NL. Tai Chi and fall reductions in older adults: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2005 Feb;60(2):187-94.

ReferenceCitation: Gillespie LD, Gillespie WJ, Robertson MC, Lamb SE, Cumming RG, Rowe BH. Interventions for preventing falls in elderly people. Cochrane Database Syst Rev. 2003;(4):CD000340. Review. Update in: Cochrane Database Syst Rev. 2009;(2):CD000340.

ReferenceCitation: Province MA, Hadley EC, Hornbrook MC, Lipsitz LA, Miller JP, Mulrow CD, Ory MG, Sattin RW, Tinetti ME, Wolf SL. The effects of exercise on falls in elderly patients. A preplanned meta-analysis of the FICSIT Trials. Frailty and Injuries: Cooperative Studies of Intervention Techniques. JAMA. 1995 May 3;273(17):1341-7.

ReferenceCitation: Lord SR, Tiedemann A, Chapman K, Munro B, Murray SM, Gerontology M, Ther GR, Sherrington C. The effect of an individualized fall prevention program on fall risk and falls in older people: a randomized, controlled trial. J Am Geriatr Soc. 2005 Aug;53(8):1296-304.

ReferenceCitation: Tinetti ME, Baker DI, McAvay G, Claus EB, Garrett P, Gottschalk M, Koch ML, Trainor K, Horwitz RI. A multifactorial intervention to reduce the risk of falling among elderly people living in the community. N Engl J Med. 1994 Sep 29;331(13):821-7.

ReferenceCitation: Robertson MC, Campbell AJ, Gardner MM, Devlin N. Preventing injuries in older people by preventing falls: a meta-analysis of individual-level data. J Am Geriatr Soc. 2002 May;50(5):905-11.

ReferenceCitation: Kannus P, Sievänen H, Palvanen M, Järvinen T, Parkkari J. Prevention of falls and consequent injuries in elderly people. Lancet. 2005 Nov 26;366(9500):1885-93. Review.

ReferenceCitation: Wolf SL, Barnhart HX, Kutner NG, McNeely E, Coogler C, Xu T. Reducing frailty and falls in older persons: an investigation of Tai Chi and computerized balance training. Atlanta FICSIT Group. Frailty and Injuries: Cooperative Studies of Intervention Techniques. J Am Geriatr Soc. 1996 May;44(5):489-97.

ReferenceCitation: Buchner DM, Hornbrook MC, Kutner NG, Tinetti ME, Ory MG, Mulrow CD, Schechtman KB, Gerety MB, Fiatarone MA, Wolf SL, et al. Development of the common data base for the FICSIT trials. J Am Geriatr Soc. 1993 Mar;41(3):297-308.

ReferenceCitation: El-Khoury F, Cassou B, Latouche A, Aegerter P, Charles MA, Dargent-Molina P. Effectiveness of two year balance training programme on prevention of fall induced injuries in at risk women aged 75-85 living in community: Ossébo randomised controlled trial. BMJ. 2015 Jul 22;351:h3830. doi: 10.1136/bmj.h3830.

family: El-Khoury

full_name: Fabienne El-Khoury

given: Fabienne

family: Cassou

full_name: Bernard Cassou

given: Bernard

family: Latouche

full_name: Aurélien Latouche

given: Aurélien

family: Aegerter

full_name: Philippe Aegerter

given: Philippe

family: Charles

full_name: Marie-Aline Charles

given: Marie-Aline

family: Dargent-Molina

full_name: Patricia Dargent-Molina

given: Patricia

journal_name: BMJ

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Castro-Lionard K, Dargent-Molina P, Fermanian C, Gonthier R, Cassou B. Use of calcium supplements, vitamin D supplements and specific osteoporosis drugs among French women aged 75-85 years: patterns of use and associated factors. Drugs Aging. 2013 Dec;30(12):1029-38. doi: 10.1007/s40266-013-0121-9.

family: Castro-Lionard

full_name: Karine Castro-Lionard

given: Karine

family: Fermanian

full_name: Christophe Fermanian

family: Gonthier

full_name: Régis Gonthier

given: Régis

title: Use of Calcium Supplements, Vitamin D Supplements and Specific Osteoporosis Drugs Among French Women Aged 75–85 Years: Patterns of Use and Associated Factors

location_facility: Centre Hospitalier Universitaire Charles Nicolle

location_facility: Centre de Prévention et de Traitement des Maladies du Vieillissement, CHRU Montpellier

location_facility: Centre de Recherche Clinique, CHU Amiens Sud


title: An Experimental Medicine, Low Grade Interventional, Clinical Study to Compare Peripheral Immune System From Subjects Without Cancer Diagnosis and Patients With Advanced Solid Tumours

acronym: IMMUNOPBMC

summary: The aim of the study is to gain knowledge concerning expression of immune markers on immune cell subpopulation of PBMCs from subjects without cancer diagnosis and cancer patients. Few studies have addressed the question of the difference of peripheric immune cells between these two populations without a specific focus on an immune cell population or an indication, and with a multiparametic approach. The present study will combine phenotypic (using cell population markers and immune checkpoints) and functional analyses toallow to better interpret non-clinical results obtained with either subjects without cancer or cancer patient material and provide rationale to use material from subjects without cancer diagnosis for functional tests. It would also argument a go to healthy volunteer's clinical trials for assessing peripheral pharmacodynamic (PD), receptor occupancy (RO) and safety (Cytokine release syndrome, CRS), in the context of early drug development in immuno-oncology. Finally, generated data will be used to feed quantitative system pharmacology (QSP) models to increase their robustness and better predict drug pharmacology in humans.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
CIC du CHU
Centre Georges Francois Leclerc


title: Pilot Study Evaluating the Feasibility and the Preliminary Effects of a Cognitive Remediation Method by Rhythmic, Vocal and Embodied Musical Learning for Stabilized Schizophrenic Patients.

acronym: ARCoS

summary:
ARCoS is a pilot study evaluating the feasibility and preliminary effects of a method of cognitive remediation by a Rhythmic, Vocal and Embodied Musical Learning for a population of stabilized schizophrenic patients. 20 stabilized schizophrenics patients will participate in the study for 9 months, i) 6 months of Musical learning (24 sessions over the 6 months) ; ii) and 3 months of follow-up post cognitive remediation. Assessments of attention deficits, inhibitory abilities, negative symptoms and anxiety, will carried out at baseline (V1, M0), third month (M3), sixth month (M6) after the start of the intervention and third months after the end of the intervention (M9).

The primary endpoint will be the proportion of patients who have attended at least 80% of the musical training sessions over the 6 months (participation in at least 19/24 sessions).

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU Toulouse
CH Marchant


title: Chronobiological Characterization of Smith Magenis Syndrome in Paediatric Age

acronym: SMS

summary:
Smith Magenis Syndrome (SMS) is a complex disorder characterized by severe neurological, psychological and behavioral disorders including sleep-wake rhythm disorders. It is a rare disease with a prevalence of 1/25 000.

The sleep disorders observed could be the consequence of a general dysregulation of the circadian system, since these patients show an inversion of the melatonin secretion profile. In SMS, the peak of melatonin is observed at 12 o'clock, whereas it is nocturnal in healthy subjects (3-4 o'clock in the morning). Daylight plays a important role in circadian regulation by inducing an inhibition of melatonin secretion via the suprachiasmatic nuclei of the hypothalamus. This mechanism could be affected in SMS children, explaining the lag of melatonin profile.

These sleep-wake disturbances cycle could play a significant role in learning deficits and in the frequency and severity of behavioral abnormalities observed in SMS.

In this project, investigators propose to study the mechanisms involved in the sleep-wake cycle disorders observed in Smith Magenis children, in particular by evaluating the quality of the pupillary reflex using a pupillometer. The pupillary reflex is a simple and non-invasive method to test light sensitivity and the photobiological mechanisms involved.

In this way, investigators want to evaluate the diurnal profile of the pupillary reflex in children with Smith Magenis syndrome in relation to the diurnal melatonin profile.

Investigators will complete this study by determining the chronobiological profile of Smith Magenis patients by measuring different variables:

Diurnal cortisol and amylase profile
24h body temperature and heart rate profile
Urinary cortisol and 6-sulfatoxymelatonin (major metabolite of melatonin) profiles
Daytime sleepiness profile measured subjectively by questionnaire and objectively via a waking EEG recording.
Actimetry at home
Polysomnography
A neurocognitive and behavioural assessment

location_facility: GénoPsy, Reference Center for Diagnosis and Management of Genetic Psychiatric Disorders, Centre Hospitalier le Vinatier and EDR-Psy Q19 Team (Centre National de la Recherche Scientifique & Lyon 1 Claude Bernard University)

location_facility: Service Épilepsie-Sommeil-Explorations Fonctionnelles Neurologiques Pédiatriques Hôpital Femme-Mère-Enfant HCL


title: Prospective Longitudinal Study of Neurological Disease Trajectory in Children Living With Late-Infantile or Juvenile Onset of GM1 or GM2 Gangliosidosis

acronym: PRONTO

summary: The study aims to characterize prospectively longitudinal progression of neurological domains in GM1 and GM2 Gangliosidosis patients with high-quality standard (GCP compliant).

lead_sponsor: Azafaros A.G.

location_facility: Armand-Trousseau Children's Hospital - CHU Paris Est


title: Pilot Study to Validate ex Vivo Expression of Specific Biomarkers of Human Resolutive Macrophages

acronym: RESOMACRO

summary: Human resolutive macrophages are essential immune cells in the resolution of inflammation. This particular type of macrophages remains poorly known and currently there are no biomarkers to identify them in vivo. Within UMR1098-RIGHT, specific biomarkers (secreted molecules and membrane receptors) of human resolutive macrophages (healthy volunteers) have been identified in vitro, but their existence in vivo remains an outstanding issue. An exploratory study (lack of data from the literature) will validate the ex vivo expression of these markers in samples of patients whose inflammation is not, or little, supported by the available therapies (NSAIDs, biotherapies, corticosteroids).

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Dentist'S Office
CHRU Besançon


title: A Prospective Longitudinal Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies

acronym: PLANET

summary: The proposal is to conduct a prospective, multi-cohort study aiming to decipher molecular profiles/biological characteristics of advanced cancer patients during the course of their disease with longitudinal and sequential analyses of tumor and liquid biopsies. This approach will allow i) to develop a model in order to predict tumor response / resistance in real life conditions and to better understand adaptive mechanisms and ii) to potentially propose therapeutic options to enrolled patients following the review of the biological/molecular data generated during this study and during a Molecular Tumor Board in case of disease progression. This study will include 12 cohorts according to tumor type and standard treatment received (See Inclusion criteria I1). Patient will be enrolled before the initiation of standard anti-cancer treatment.

lead_sponsor: Centre Leon Berard

location_facility:
Centre Léon Bérard
HOPITAL Pierre WERTHEIMER - HCL


title: Immunotherapy Clearance and Phenotype of Circulating Tumor Cells in Patients With Lung and Head and Neck Cancers, Treated With an Immunotherapy-based Therapy

acronym: MADMAS

summary:
Immunotherapy is widely administrated as anticancer treatment in metastatic setting. Despite a proved efficacy in several cancer types and clinical situations, it exists a wide variability of responses in terms of efficacy and toxicity. The rate of responders depends mostly on the type of pathology, with 40% of responders among melanoma patients, 20-30% among lung and head and neck cancer patients and only 1% of responders among pancreatic cancer patients. Thus, the main challenge today is to be able to select patients for whom the treatment is likely to be effective. Several studies suggested that tumors with a high mutational burden and expressing PD-L1 are better responders to immunotherapy.

However, a proportion of PD-L1 negative cancers responds to immunotherapy, suggesting that other parameters have to be considered together with PD-L1 expression. Of that, the immunotherapy clearance seems to have an impact on overall survival, but larger studies, including different molecules and cancer types, are needed to better understand the correlation between the clearance and the response to immunotherapy.

Tumor cells released from the primary tumor in the blood circulation (CTCs, for circulating tumor cells) are considered as "liquid biopsies", as they contain the entire genetic and phenotypic information representative of the tumor, including PD-L1 expression. Thus, the variation of PD-L1 expression under treatment can be easily followed-up on blood samples collected during the time.

The objective of MADMAS is to study the correlation between the immunotherapy clearance, measured at the different times during treatment, and the variation of the number of CTCs expressing PD-L1 after two cures of treatment.

MADMAS will enroll patients with lung or head and neck cancers, treated with an immunotherapy-based therapy. Blood samples will be collected at the baseline and before the first two cures of treatment. The immunotherapy clearance will be measured with an innovative approach of Mass Spectrometry, and PD-L1 expression will be measured on CTCs, purified with a highly sensitive microfluidics technology.

location_facility:
Lyon Sud Hospital
Croix Rousse Hospital


type: Registry Identifier

title: Transcatheter Edge to Edge Mitral Valve Repair Versus Standard Surgical Mitral Valve Operation for Secondadry Mitral Regurgitation

acronym: TEERMISO

summary: The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER). The key question of this study is to establish the difference in left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-systolic dimension(LVESD), all-cause and cause-specific (cardiac vs noncardiac) mortality in patients who received the TEER vs the standard surgical procedure for SMR.

lead_sponsor: Centre Cardiologique du Nord

location_facility:
Francesco Nappi
Centre Cardiologique Du Nord


title: Analysis of Circulating Tumor mArkers in Blood 4 - ALCINA 4

summary:
Multi-cohort exploratory prospective study. Participation in the ALCINA 4 study does not change the standard management of the patient, including the treatments administered. A sampling schedule will be set up for each cohort.

Depending on the clinical context studied and the biomarkers studied and/or sought, the timing of blood samples will vary between cohorts. There may be up to 4 samples taken per patient for up to 12 or 18 months. If a specific tumor sample is required, it will be collected only once during the study.

lead_sponsor: Institut Curie


title: Prospective Multicenter Randomized Controlled 1:1 Study Evaluating the Efficacy of a 3D Digital Operating Microscope Compared to Conventional Microscopes Microscopes on the Comfort and Subjective Visual Sensations of the Patients Related to the Microscope Light During Initial Cataract Surgery Under Topical Anesthesia Topical Anesthesia

acronym: COOL

summary:
Digital 3D microscopes require less light and may be more comfortable for patients requiring cataract surgery under topical anesthesia compared to conventional microscopes.

To date, no studies have evaluated the comfort and subjective visual sensations related to the light of the 3D digital microscope in cataract surgery patients.

The purpose of this study is to evaluate the effectiveness of the Ngenuity 3D digital operating system (Alcon, Fort Worth, TX) compared to conventional microscopes on the comfort and subjective visual sensations related to of patients undergoing initial cataract surgery under topical anesthesia (pure or combined with intravenous sedation).

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility:
Clinique Honoré Cave
Hôpital Fondation A. de Rothschuld


title: Validation of the Relationship Between Oxygenation Parameters and the Oxygen Reserve Index (ORI™), in Mechanically Ventilated ICU Patients: An Exploratory Pathophysiology Study

summary: The ORI™ or Oxygen Reserve Index (Masimo, Irvine, CA, USA) is a non-invasive monitoring system for measuring oxygen reserve. It is a digital sensor (almost identical to the SpO2 sensor) which allows an analysis of the absorption of arterial, venous and capillary components. The measured index, unitless, ranges from 0.00 to 1.00 for moderate hyperoxia levels: from 100 to 200 mmHg. It can alert the clinician to a drop in oxygen stores via the drop in SvO2 before a drop in SpO2 is observed. We propose to carry out a study to elucidate correlation between ORI™ and PaO2.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU
Clermont-Ferrand University Hospital


title: Multicenter, Randomized, Open-label Study Evaluating the Efficacy of Aponeurectomy Associated With Adipose Tissue Grafting Compared to Aponeurectomy Alone, on the 2-year Recurrence Rate of Dupuytren's Disease (REMEDY).

acronym: REMEDY

summary:
Dupuytren's disease is a frequent hereditary disease in Northern Europe. It is a degenerative disease affecting the palmar aponeurosis of the hand. It develops a progressive contractile fibrosis which cuts the hypodermic fatty tissue, adheres to the skin and the phalanges, gradually bending the affected rays, resulting in significant functional impotence.

Various medical and surgical treatments are available.

ReferenceCitation: Selles RW, Zhou C, Kan HJ, Wouters RM, van Nieuwenhoven CA, Hovius SER. Percutaneous Aponeurotomy and Lipofilling versus Limited Fasciectomy for Dupuytren's Contracture: 5-Year Results from a Randomized Clinical Trial. Plast Reconstr Surg. 2018 Dec;142(6):1523-1531. doi: 10.1097/PRS.0000000000004982.

ReferenceCitation: Henry M. Dupuytren's disease: current state of the art. Hand (N Y). 2014 Mar;9(1):1-8. doi: 10.1007/s11552-013-9563-0. Review.

ReferenceCitation: Engstrand C, Krevers B, Nylander G, Kvist J. Hand function and quality of life before and after fasciectomy for Dupuytren contracture. J Hand Surg Am. 2014 Jul;39(7):1333-1343.e2. doi: 10.1016/j.jhsa.2014.04.029.

ReferenceCitation: Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S.

ReferenceCitation: Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28.

ReferenceCitation: Mojallal A, Lequeux C, Shipkov C, Breton P, Foyatier JL, Braye F, Damour O. Improvement of skin quality after fat grafting: clinical observation and an animal study. Plast Reconstr Surg. 2009 Sep;124(3):765-774. doi: 10.1097/PRS.0b013e3181b17b8f.

ReferenceCitation: Verhoekx JSN, Mudera V, Walbeehm ET, Hovius SER. Adipose-derived stem cells inhibit the contractile myofibroblast in Dupuytren's disease. Plast Reconstr Surg. 2013 Nov;132(5):1139-1148. doi: 10.1097/PRS.0b013e3182a3bf2b.

ReferenceCitation: Foucher G, Medina J, Navarro R. Percutaneous needle aponeurotomy: complications and results. J Hand Surg Br. 2003 Oct;28(5):427-31.

ReferenceCitation: Kan HJ, Verrijp FW, Hovius SER, van Nieuwenhoven CA; Dupuytren Delphi Group, Selles RW. Recurrence of Dupuytren's contracture: A consensus-based definition. PLoS One. 2017 May 15;12(5):e0164849. doi: 10.1371/journal.pone.0164849. eCollection 2017. Erratum in: PLoS One. 2019 Apr 25;14(4):e0216313.

ReferenceCitation: Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46.

ReferenceCitation: Mintken PE, Glynn P, Cleland JA. Psychometric properties of the shortened disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) and Numeric Pain Rating Scale in patients with shoulder pain. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):920-6. doi: 10.1016/j.jse.2008.12.015. Epub 2009 Mar 17.

lead_sponsor: Elsan

location_facility:
Institut Aquitain de la Main
Clinique du Diaconat