title: Automated Multiparameter in Situ Study Comparing the Microenvironment of Head and Neck Cancers Among West Indies and Metropolitan Populations: Screening for Predictive Markers of Overall Survival and Immunotherapy Responses.

acronym: MituHPV

summary: Retrospective observational comparative and multicentric study of the microenvironment of HPV-induced head and neck cancers, with comparison between West Indies and Metropolitan populations, and therapeutic implications. This assessment is carried out by in situ multiparametric study with multiple immunofluorescence staining for cluster of differentiation 3, cluster of differentiation 4, cluster of differentiation 8, PROGRAMMED DEATH-1, PROGRAMMED DEATH-L1, PROGRAMMED DEATH-L2, cytokeratin and cluster of differentiation 68 and automated reading. HPV genotypes will be characterized. Learning these techniques will allow me to promote them in West Indies on my way back, and they may be applicable to other HPV-induced cancers.

location_country: Martinique France

location_facility:
Hôpital Européen Georges Pompidou
CHU Martinique


title: Inflammatory Signature of Chorionic Cells as Markers of Premature Labor

acronym: TROPHY

summary: The purpose of this study is to identify molecules produced specifically by the cells from the chorionic membranes of the materno-fetal interface ("the water bag") sign for the activation of preterm labor.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Hervé R, Schmitz T, Evain-Brion D, Cabrol D, Leroy MJ, Méhats C. The PDE4 inhibitor rolipram prevents NF-kappaB binding activity and proinflammatory cytokine release in human chorionic cells. J Immunol. 2008 Aug 1;181(3):2196-202.

ReferenceCitation: Méhats C, Schmitz T, Marcellin L, Breuiller-Fouché M. [Biochemistry of fetal membranes rupture]. Gynecol Obstet Fertil. 2011 Jun;39(6):365-9. doi: 10.1016/j.gyobfe.2011.04.006. Epub 2011 May 24. French.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


type: Registry Identifier

type: Other Identifier

title: Long-term Effects of Visual Spatial Working Memory Training Program Performed at Preschool Age in Very Preterm Infants With Visual Spatial Working Memory Deficit. A Randomized Controlled Trial

acronym: EPIREMED

summary:
Prematurity tends to increase in France in recent years and more children born extremely premature infants survive. If severe impairments have stabilized, the majority of former extremely premature children have neuropsychological disorders and moderate appearance behavior disorder, but with a significant impact both family, school and social persisting into adulthood.

Executive functions (EF), in general, and working memory (MT), in particular, are frequently altered in older children preterm infants compared to controls born at term.

The identification process of loss in certain diseases, as well as improving knowledge of brain functioning, and development with the possibility of neuronal plasticity has led research teams to develop intervention programs focused on process cognitive qualified of "remediation" cognitive (RC). Schematically, the RC is defined as a rehabilitation or altered cognitive functions. MT can be improved by encouraging the operation of the spots mental stimulant. These programs are effective on MT but do not have the expected impact on other FE, language or nonverbal functions (visuospatial). The functional benefit of cognitive remediation remains controversial.

Improving mental functions untrained as nonverbal MT, attention and secondarily learning is possible but still unproven on wide population. Similarly, randomized trials are needed to test this type of cognitive remediation among preschoolers old very premature.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Gire C, Beltran Anzola A, Kaminski M, Baumstarck K, Ancel PY, Berbis J; for EPIREMED-Study Group. A randomized EPIREMED protocol study on the long-term visuo spatial effects of very preterm children with a working memory deficit. BMC Pediatr. 2021 Sep 13;21(1):402. doi: 10.1186/s12887-021-02867-x.

family: Gire

full_name: Catherine Gire

given: Catherine

sequence: first

family: Beltran Anzola

full_name: Any Beltran Anzola

given: Any

sequence: additional

family: Kaminski

full_name: Monique Kaminski

given: Monique

family: Baumstarck

full_name: Karine Baumstarck

given: Karine

family: Ancel

full_name: Pierre-Yves Ancel

given: Pierre-Yves

family: Berbis

full_name: Julie Berbis

given: Julie

family: Zahed

full_name: Meriem Zahed

given: Meriem

family: Garcia

full_name: Patricia Garcia

given: Patricia

family: Desiles

full_name: Tristan Desiles

given: Tristan

full_name: Ludovic Zahed

given: Ludovic

family: Pache

full_name: Mélodie Pache

given: Mélodie

family: Menard

full_name: Gwenaëlle Menard

given: Gwenaëlle

family: Bednarek Weirauch

full_name: Nathalie Bednarek Weirauch

given: Nathalie

family: Voirin

full_name: Karine Voirin

family: Verriere

full_name: Virginie Verriere

given: Virginie

family: Cambonie

full_name: Gilles Cambonie

given: Gilles

family: Lerat

full_name: Claire Lerat

given: Claire

family: Poujol

full_name: Maythé Poujol

given: Maythé

family: Claris

full_name: Olivier Claris

given: Olivier

family: Rubio Gurung

full_name: Sophie Rubio Gurung

given: Sophie

family: Basson

full_name: Eliane Basson

given: Eliane

family: Rodriguez

full_name: Melanie Rodriguez

given: Melanie

family: Rannaud

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

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

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Regional University Hospital of Strasbourg

location_facility: Assistance Publique Hôpitaux de Marseille


title: Is a History of Pre-eclampsia Before Systemic Sclerosis Onset a Risk Factor for Vascular Phenotype in Women With Systemic Sclerosis?

acronym: PREVASCLERO

summary:
Background:

Pre-eclampsia, defined by the association of an arterial hypertension and significant proteinuria after 20 weeks of gestation, complicates 1 to 2% of pregnancies in France. Its pathophysiology involves angiogenesis impairment, upregulated maternal systemic inflammatory response, activation of oxidative stress and endothelial dysfunction.

In a recent Danish nation-wide cohort study, pre-eclampsia was associated with a 69% increased risk of later developing scleroderma.

Type of study: prospective observational case-control study. Primary objective of the study: to determine if a history of pre-eclampsia before systemic sclerosis diagnosis is an independent risk factor for vascular phenotype in sclerodermic women.

Secondary objective: to describe all risk factors for vascular phenotype in sclerodermic women with a previous pregnancy longer than 6 months before scleroderma diagnosis.

ReferenceCitation: Société française d'anesthésie et de réanimation (Sfar); Collège national des gynécologues et obstétriciens français (CNGOF); Société française de médecine périnatale (SFMP); Société française de néonatalogie (SFNN). [Multidisciplinary management of severe pre-eclampsia (PE). Experts' guidelines 2008. Société française d'anesthésie et de réanimation. Collège national des gynécologues et obstétriciens français. Société française de médecine périnatale. Société française de néonatalogie]. Ann Fr Anesth Reanim. 2009 Mar;28(3):275-81. doi: 10.1016/j.annfar.2009.02.015. Epub 2009 Mar 24. French.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annales Françaises d'Anesthésie et de Réanimation

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Prise en charge multidisciplinaire de la prééclampsie. Recommandations formalisées d’experts communes

ReferenceCitation: Saucedo M, Deneux-Tharaux C, Bouvier-Colle MH; Le Comité national d'experts sur la mortalité maternelle. [Maternal mortality in France, 2007-2009]. J Gynecol Obstet Biol Reprod (Paris). 2013 Nov;42(7):613-27. doi: 10.1016/j.jgyn.2013.06.011. Epub 2013 Sep 13. French.

family: Saucedo

full_name: M. Saucedo

given: M.

family: Deneux-Tharaux

full_name: C. Deneux-Tharaux

given: C.

family: Bouvier-Colle

full_name: M.-H. Bouvier-Colle

journal_name: Journal de Gynécologie Obstétrique et Biologie de la Reproduction

title: Épidémiologie de la mortalité maternelle en France, 2007–2009

ReferenceCitation: Conrad KP, Miles TM, Benyo DF. Circulating levels of immunoreactive cytokines in women with preeclampsia. Am J Reprod Immunol. 1998 Aug;40(2):102-11.

ReferenceCitation: Redman CW, Sargent IL. Pre-eclampsia, the placenta and the maternal systemic inflammatory response--a review. Placenta. 2003 Apr;24 Suppl A:S21-7. Review.

ReferenceCitation: Zhou CC, Zhang Y, Irani RA, Zhang H, Mi T, Popek EJ, Hicks MJ, Ramin SM, Kellems RE, Xia Y. Angiotensin receptor agonistic autoantibodies induce pre-eclampsia in pregnant mice. Nat Med. 2008 Aug;14(8):855-62. doi: 10.1038/nm.1856. Epub 2008 Jul 27.

ReferenceCitation: Herse F, Verlohren S, Wenzel K, Pape J, Muller DN, Modrow S, Wallukat G, Luft FC, Redman CW, Dechend R. Prevalence of agonistic autoantibodies against the angiotensin II type 1 receptor and soluble fms-like tyrosine kinase 1 in a gestational age-matched case study. Hypertension. 2009 Feb;53(2):393-8. doi: 10.1161/HYPERTENSIONAHA.108.124115. Epub 2008 Dec 8.

ReferenceCitation: Lim R, Acharya R, Delpachitra P, Hobson S, Sobey CG, Drummond GR, Wallace EM. Activin and NADPH-oxidase in preeclampsia: insights from in vitro and murine studies. Am J Obstet Gynecol. 2015 Jan;212(1):86.e1-12. doi: 10.1016/j.ajog.2014.07.021. Epub 2014 Jul 18.

ReferenceCitation: Roberts JM, Taylor RN, Musci TJ, Rodgers GM, Hubel CA, McLaughlin MK. Preeclampsia: an endothelial cell disorder. Am J Obstet Gynecol. 1989 Nov;161(5):1200-4.

ReferenceCitation: Bellamy L, Casas JP, Hingorani AD, Williams DJ. Pre-eclampsia and risk of cardiovascular disease and cancer in later life: systematic review and meta-analysis. BMJ. 2007 Nov 10;335(7627):974. Epub 2007 Nov 1. Review.

ReferenceCitation: Kamper-Jørgensen M, Gammill HS, Nelson JL. Preeclampsia and scleroderma: a prospective nationwide analysis. Acta Obstet Gynecol Scand. 2018 May;97(5):587-590. doi: 10.1111/aogs.13296. Epub 2018 Feb 8.

name: Department of Public Health; University of Copenhagen; Copenhagen Denmark

family: Kamper-Jørgensen

full_name: Mads Kamper-Jørgensen

given: Mads

name: Department of Obstetrics and Gynecology; University of Washington; Seattle WA USA

name: Clinical Research Division; Fred Hutchinson Cancer Research Center; Seattle WA USA

family: Gammill

full_name: Hilary S. Gammill

given: Hilary S.

name: Department of Medicine, Rheumatology; University of Washington; Seattle WA USA

family: Nelson

full_name: J. Lee Nelson

given: J. Lee

journal_name: Acta Obstetricia et Gynecologica Scandinavica

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

version: submittedVersion

repositories:
PubMed Central
Pure (Denmark)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: van Wyk L, van der Marel J, Schuerwegh AJ, Schouffoer AA, Voskuyl AE, Huizinga TW, Bianchi DW, Scherjon SA. Increased incidence of pregnancy complications in women who later develop scleroderma: a case control study. Arthritis Res Ther. 2011;13(6):R183. doi: 10.1186/ar3510. Epub 2011 Nov 4.

family: van Wyk

full_name: Linda van Wyk

given: Linda

family: van der Marel

full_name: Jacolien van der Marel

given: Jacolien

family: Schuerwegh

full_name: Annemie JM Schuerwegh

given: Annemie JM

family: Schouffoer

ReferenceCitation: Englert H, Small-McMahon J, Davis K, O'Connor H, Chambers P, Brooks P. Systemic sclerosis prevalence and mortality in Sydney 1974-88. Aust N Z J Med. 1999 Feb;29(1):42-50.

ReferenceCitation: Lee P, Langevitz P, Alderdice CA, Aubrey M, Baer PA, Baron M, Buskila D, Dutz JP, Khostanteen I, Piper S, et al. Mortality in systemic sclerosis (scleroderma). Q J Med. 1992 Feb;82(298):139-48.

ReferenceCitation: Simeón CP, Armadans L, Fonollosa V, Solans R, Selva A, Villar M, Lima J, Vaqué J, Vilardell M. Mortality and prognostic factors in Spanish patients with systemic sclerosis. Rheumatology (Oxford). 2003 Jan;42(1):71-5.

ReferenceCitation: Jacobsen S, Halberg P, Ullman S. Mortality and causes of death of 344 Danish patients with systemic sclerosis (scleroderma). Br J Rheumatol. 1998 Jul;37(7):750-5.

ReferenceCitation: Hesselstrand R, Scheja A, Akesson A. Mortality and causes of death in a Swedish series of systemic sclerosis patients. Ann Rheum Dis. 1998 Nov;57(11):682-6.

ReferenceCitation: LeRoy EC, Black C, Fleischmajer R, Jablonska S, Krieg T, Medsger TA Jr, Rowell N, Wollheim F. Scleroderma (systemic sclerosis): classification, subsets and pathogenesis. J Rheumatol. 1988 Feb;15(2):202-5.

ReferenceCitation: van den Hoogen F, Khanna D, Fransen J, Johnson SR, Baron M, Tyndall A, Matucci-Cerinic M, Naden RP, Medsger TA Jr, Carreira PE, Riemekasten G, Clements PJ, Denton CP, Distler O, Allanore Y, Furst DE, Gabrielli A, Mayes MD, van Laar JM, Seibold JR, Czirjak L, Steen VD, Inanc M, Kowal-Bielecka O, Müller-Ladner U, Valentini G, Veale DJ, Vonk MC, Walker UA, Chung L, Collier DH, Csuka ME, Fessler BJ, Guiducci S, Herrick A, Hsu VM, Jimenez S, Kahaleh B, Merkel PA, Sierakowski S, Silver RM, Simms RW, Varga J, Pope JE. 2013 classification criteria for systemic sclerosis: an American College of Rheumatology/European League against Rheumatism collaborative initiative. Arthritis Rheum. 2013 Nov;65(11):2737-47. doi: 10.1002/art.38098. Epub 2013 Oct 3.

ReferenceCitation: Riemekasten G, Philippe A, Näther M, Slowinski T, Müller DN, Heidecke H, Matucci-Cerinic M, Czirják L, Lukitsch I, Becker M, Kill A, van Laar JM, Catar R, Luft FC, Burmester GR, Hegner B, Dragun D. Involvement of functional autoantibodies against vascular receptors in systemic sclerosis. Ann Rheum Dis. 2011 Mar;70(3):530-6. doi: 10.1136/ard.2010.135772. Epub 2010 Nov 15.

ReferenceCitation: Walther T, Wallukat G, Jank A, Bartel S, Schultheiss HP, Faber R, Stepan H. Angiotensin II type 1 receptor agonistic antibodies reflect fundamental alterations in the uteroplacental vasculature. Hypertension. 2005 Dec;46(6):1275-9. Epub 2005 Oct 31.

ReferenceCitation: Nelson JL, Furst DE, Maloney S, Gooley T, Evans PC, Smith A, Bean MA, Ober C, Bianchi DW. Microchimerism and HLA-compatible relationships of pregnancy in scleroderma. Lancet. 1998 Feb 21;351(9102):559-62.

ReferenceCitation: Allanore Y, Distler O, Matucci-Cerinic M, Denton CP. Review: Defining a Unified Vascular Phenotype in Systemic Sclerosis. Arthritis Rheumatol. 2018 Feb;70(2):162-170. doi: 10.1002/art.40377. Epub 2018 Jan 22. Review.

ReferenceCitation: Lescoat A, Yelnik CM, Coiffier G, Wargny M, Lamotte C, Cazalets C, Belhomme N, Ballerie A, Hatron PY, Launay D, Perdriger A, Sobanski V, Hachulla E, Jégo P. Ulnar Artery Occlusion and Severity Markers of Vasculopathy in Systemic Sclerosis: A Multicenter Cross-Sectional Study. Arthritis Rheumatol. 2019 Jun;71(6):983-990. doi: 10.1002/art.40799. Epub 2019 Apr 29.

ReferenceCitation: Diehl CL, Brost BC, Hogan MC, Elesber AA, Offord KP, Turner ST, Garovic VD. Preeclampsia as a risk factor for cardiovascular disease later in life: validation of a preeclampsia questionnaire. Am J Obstet Gynecol. 2008 May;198(5):e11-3. doi: 10.1016/j.ajog.2007.09.038. Epub 2008 Feb 1.

journal_name: American Journal of Obstetrics and Gynecology

ipd_sharing_description: All collected data that underlie results in a publication

location_facility:
CHU de Dijon
CHU de Nantes
CHU de Strasbourg
CHU de Limoges
CHU de Lille
CHU de Nice
CHU de Clermont-Ferrand
CHU de Tours
CHU de Rennes
CHU de Toulouse


title: Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial.

acronym: CASCADOR

summary:
Hypothesis:

In France, approximately 12,000 new rectal cancers are diagnosed each year. Frequency is one and a half times higher in men than in women. The average age of diagnosis is 65. Unlike colon cancer, technical management remains challenging with unresolved operating difficulties. Morbidity of surgical procedures remains high with a very large number of preventive or curative stoma derivations.

Reference in surgical treatment is total excision of the rectum and its mesentery, followed by continuity restoration by immediate coloanal anastomosis (ACAI). In this procedure, rate of fistula that results is reported in the literature between 15 and 25%.

An alternative to ACAI is delayed coloanal anastomosis without reservoir (ACAD). Based on retrospective experiences, we form the hypothesis that ACAD offers a much lower rate of fistula (<5%) and allows diminution of preventive stoma derivation practice. Morbidity and mortality are reduced, and patient's quality of life greatly improved. Direct costs (consumables intraoperative, hospitalization, stoma complications) and indirect (pocket-fitting stoma) are greatly reduced.

This study is a multicentre, two arms, phase 2 clinical trial.

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: Institut Bergonié

location_facility: HOSPICES CIVILS DE LYON - Hôpital de la Croix Rousse

intervention_type: Procedure

lead_sponsor_type: industriel


title: Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System.

summary: The main objective of this study is to validate a simplified platform of a repositioning system in orthognathic surgery (a third generation optic repositioning system called MicronTracker) compared with the actual clinically validated one (Orthopilot system).

status: Suspended

ReferenceCitation: Bettega G, Cinquin P, Lebeau J, Raphaël B. Computer-assisted orthognathic surgery: clinical evaluation of a mandibular condyle repositioning system. J Oral Maxillofac Surg. 2002 Jan;60(1):27-34; discussion 34-5.

ReferenceCitation: Bettega G, Dessenne V, Raphaël B, Cinquin P. Computer-assisted mandibular condyle positioning in orthognathic surgery. J Oral Maxillofac Surg. 1996 May;54(5):553-8.

ReferenceCitation: Dessenne V. Gestes médico-chirurgicaux assistés par ordinateur: applications à la ligamentoplastie du genou et à la chirurgie orthognatique. Thèse de Génie biologique et médical, Grenoble 1996

ReferenceCitation: Bettega G. La chirurgie orthognatique assistée par ordinateur: de la planification à la réalisation. Thèse de Génie biologique et médical, Grenoble 1997

lead_sponsor: University Hospital, Grenoble

location_facility: Maxillofacial and Plastic Surgery Department - University Hospital of Grenoble

intervention_type: Device

status_simplified: Unknown


title: Pan-genome Analysis of Neuroblastoma by Comparative Genomic Hybridization and Correlation With Pathology for the Diagnostic and the Prognostic Classification

summary:
Neuroblastoma (NB) is characterized by its wide heterogeneity in clinical presentation and evolution. Recent retrospective studies have revealed by CGH-array that the overall genomic pattern is an important prognostic marker which might be taken into account for treatment stratification.

This protocol deals with a prospective analysis of the genomic profile established by CGH-array on the tumor samples obtained at the diagnosis of all the patients with NB in France, to obtain genomic profiles and being able to determine their prognostic impact in the various protocols of treatment. The objective of this study will be a better therapeutic stratification in the future trials, studies or protocols of treatment.

status: Active, not recruiting

primary_purpose: Basic Science

ipd_sharing: No

lead_sponsor: Institut Curie

location_facility: Hopital de La Mere Et de L'Enfant Limoges

status_simplified: Ongoing


title: Impairment of Central Coherence in Restrictive Anorexia Nervosa: Single-center and Case-control Study

acronym: CoCA

summary:
The current etiological pathological model of anorexia nervosa is poly-factorial involving individual genetic and psychological factors, in close interaction with environmental, family and socio-cultural factors.

Among these factors, this study focuses on the central coherence process (cognitive ability to integrate complex information into a comprehensive meaning), in the active phase of the disease. Therefore, patients followed in the addiction service of the Nantes University Hospital will perform neuropsychological tests assessing executive functions involved in the process of central coherence.

Impairment of central coherence process could act as a maintenance factor of the disease, particularly in connection with body dysmorphic disorder. The therapeutic perspectives acting on the central coherence process like cognitive remediation deserve to deepen knowledge on the cognitive profile of patients with anorexia nervosa.

primary_purpose: Other

lead_sponsor: Nantes University Hospital

intervention_type: Behavioral


title: Pro-inflammatory Role of Blood Platelets in Critically Ill Patients With Septic Shock: an Observational Study.

acronym: PLAQSIS

summary: Blood platelets play a major role in the inflammatory response. A dysregulation of platelets activation may be one of the contributors to tissue damage in critically ill patients with septic shock. The main objective of this study is to compare platelet activation markers levels (including plasma concentration in CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha and HMGB-1) at the early phase of a septic shock and a systemic inflammatory response syndrome (SIRS).

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hôpital Saint Louis
Hôpital Haut Lévêque


title: Retrospective Efficacy and Safety Study With Elbasvir 50 mg/Grazoprevir 100 mg in HCV-infected Patients With Chronic Kidney Disease Stage 4-5 During the French Temporary Authorization for Use (ATU) Program: Data From Real-life

summary: Retrospective Efficacy and Safety Study With Elbasvir (EBR) 50 mg/Grazoprevir (GZR) 100 mg in Hepatitis C Virus (HCV)-infected Patients With Chronic Kidney Disease (CKD) Stage 4-5 During the French Temporary Authorization for Use (ATU) Program: Data From Real-life

time_perspective: Retrospective

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital
University Hospital Toulouse

intervention_type: Drug


title: Plasmatic Level of Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a Predictive Marker of Acute Kidney Failure in Patients With Preoperative Chronic Kidney Failure Undergoing Cardiac Surgery.

acronym: NGAL-CKF

summary: Primary endpoint: To evaluate predictive value of plasmatic levels of Neutrophil Gelatinase Associated Lipocalin (NGAL) to reveal acute kidney failure after cardiac surgery in patients with preoperative chronic kidney failure Secondary endpoint is to obtain threshold values of NGAL.

status: Unknown status

lead_sponsor: Hopital Jean Minjoz

location_facility: Centre hospitalier Universitaire (CHU) Jean Minjoz


title: A Prospective, Open Label Study Assessing the 24-hour Intraocular Pressure Pattern Monitored by SENSIMED Triggerfish® in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After Laser Peripheral Iridotomy

summary: The purpose of the study is to determine the relationship of the intraocular pressure patterns recorded during 2 sessions using Triggerfish, before and after elective laser peripheral iridotomy in angle closure glaucoma patients

status: Withdrawn

primary_purpose: Diagnostic

lead_sponsor: Sensimed AG

location_facility: CHNO des Quinze-Vingts, 28 rue Charenton


title: Qualitative Outcomes After Palliative Noninvasive Mechanical Ventilation : OVNI Study

acronym: OVNI

summary:
The purpose of this study is:

to estimate the frequency of the use of non invasive ventilation
to estimate the frequency of the use of palliative non invasive ventilation
to evaluate the impact of non invasive ventilation
to propose some recommendations

ReferenceType: result

ReferenceCitation: Demoule A, Chevret S, Carlucci A, Kouatchet A, Jaber S, Meziani F, Schmidt M, Schnell D, Clergue C, Aboab J, Rabbat A, Eon B, Guérin C, Georges H, Zuber B, Dellamonica J, Das V, Cousson J, Perez D, Brochard L, Azoulay E; oVNI Study Group; REVA Network (Research Network in Mechanical Ventilation). Changing use of noninvasive ventilation in critically ill patients: trends over 15 years in francophone countries. Intensive Care Med. 2016 Jan;42(1):82-92. doi: 10.1007/s00134-015-4087-4. Epub 2015 Oct 13.

family: Demoule

full_name: Alexandre Demoule

given: Alexandre

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Carlucci

full_name: Annalisa Carlucci

given: Annalisa

family: Kouatchet

full_name: Achille Kouatchet

given: Achille

family: Jaber

full_name: Samir Jaber

given: Samir

family: Meziani

full_name: Ferhat Meziani

given: Ferhat

family: Schmidt

full_name: Matthieu Schmidt

given: Matthieu

family: Schnell

full_name: David Schnell

given: David

family: Clergue

full_name: Céline Clergue

given: Céline

family: Aboab

full_name: Jérôme Aboab

given: Jérôme

family: Rabbat

full_name: Antoine Rabbat

given: Antoine

family: Eon

full_name: Béatrice Eon

given: Béatrice

family: Guérin

full_name: Claude Guérin

given: Claude

family: Georges

full_name: Hugues Georges

given: Hugues

family: Zuber

full_name: Benjamin Zuber

given: Benjamin

family: Dellamonica

full_name: Jean Dellamonica

given: Jean

family: Das

full_name: Vincent Das

given: Vincent

family: Cousson

full_name: Joël Cousson

given: Joël

family: Perez

full_name: Didier Perez

given: Didier

family: Brochard

full_name: Laurent Brochard

given: Laurent

family: Azoulay

full_name: Elie Azoulay

given: Elie

journal_name: Intensive Care Medicine

oa_host_type: repository

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

ReferenceCitation: Azoulay E, Kouatchet A, Jaber S, Lambert J, Meziani F, Schmidt M, Schnell D, Mortaza S, Conseil M, Tchenio X, Herbecq P, Andrivet P, Guerot E, Lafabrie A, Perbet S, Camous L, Janssen-Langenstein R, Collet F, Messika J, Legriel S, Fabre X, Guisset O, Touati S, Kilani S, Alves M, Mercat A, Similowski T, Papazian L, Meert AP, Chevret S, Schlemmer B, Brochard L, Demoule A. Noninvasive mechanical ventilation in patients having declined tracheal intubation. Intensive Care Med. 2013 Feb;39(2):292-301. doi: 10.1007/s00134-012-2746-2. Epub 2012 Nov 27.

ReferenceCitation: Dangers L, Montlahuc C, Kouatchet A, Jaber S, Meziani F, Perbet S, Similowski T, Resche-Rigon M, Azoulay E, Demoule A; REVA Network (Research Network in Mechanical Ventilation) and the Groupe de Recherche en Réanimation Respiratoire en Onco-Hématologie (GrrrOH); List of contributors who included study patients: Angers University Hospital, Angers, France:. Dyspnoea in patients receiving noninvasive ventilation for acute respiratory failure: prevalence, risk factors and prognostic impact: A prospective observational study. Eur Respir J. 2018 Aug 9;52(2). pii: 1702637. doi: 10.1183/13993003.02637-2017. Print 2018 Aug.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement


ReferenceCitation: Tsatsaris V, Capitant C, Schmitz T, Chazallon C, Bulifon S, Riethmuller D, Picone O, Poulain P, Lewin F, Lainé F, Jacqz-Aigrain E, Aboulker JP, Launay O; Inserm C09-33 PREFLUVAC (Immunogenicity and Safety of an Inactivated Nonadjuvanted A[H1N1v] Influenza Vaccine in Pregnant Women) Study Group. Maternal immune response and neonatal seroprotection from a single dose of a monovalent nonadjuvanted 2009 influenza A(H1N1) vaccine: a single-group trial. Ann Intern Med. 2011 Dec 6;155(11):733-41. doi: 10.7326/0003-4819-155-11-201112060-00005.

family: Tsatsaris

full_name: Vassilis Tsatsaris

given: Vassilis

journal_name: Annals of Internal Medicine

publisher: American College of Physicians

publisher_dissemination: American College of Physicians

publisher_group: American College of Physicians

publisher_normalized: American College of Physicians

title: Maternal Immune Response and Neonatal Seroprotection From a Single Dose of a Monovalent Nonadjuvanted 2009 Influenza A(H1N1) Vaccine

intervention_type: Biological

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

primary_purpose: Prevention

acronym: PREFLUVAC

location_facility: Groupe hospitalier Cochin Saint Vincent de Paul

type: EudraCT Number

source: euctr

title: Etude de Phase II évaluant l'immunogénicité et la tolérance d'un Vaccin inactivé Non adjuvanté Contre la Grippe A(H1N1)v Chez la Femme Enceinte

summary:
The purpose of this study is to evaluate the immunogenicity and safety of an inactivated, non adjuvanted A(H1N1)v influenza vaccine in 120 pregnant women.

Study procedures will include 2 doses of vaccine, blood samples, cord blood samples at delivery and recording temperature and vaccine side effects in a memory aid for 7 days following each vaccination. Participants will be involved in study related procedures about 3 at 5 months.


title: Pneumatic Reversible Portal Vein Diameter Modulation After Major Hepatectomy in Non Cirrhotic Patient

summary: This ring aimed to preserve an intra-hepatic porto-caval gradient inferior to 5 mm Hg during and after major hepatectomy (48h) to protect the liver during the initial phases of liver regeneration. Morphological features of MID-AVRTM allow its intra corporeal opening and percutaneously removal after an balloon inflation with 5 ml of physiological serum. MID-AVRTM had been developed in pig where it had proved its efficiency to improve liver function after 75% hepatectomy and its capacity to be removed percutaneously. Aim of this feasibility study (Phase I/II) is to prove in series of 3 evaluable patients (Phase A) then 6 evaluable patients (Phase B) that MID-AVRTM could be used in human without deleterious consequence. In phase A, MID-AVRTM is dispose around the portal vein before and during a major hepatectomy performed on healthy liver and removed before abdominal closure. If phase A results confirmed that MID-AVRTM well modulates portal pressure and is easily opened and removed by acute inflation, the phase B will be started. In phase B, MID-AVRTM will be dispose around the portal vein before major hepatectomy on healthy liver and conserved 48 hours before to be removed percutaneously at the operating room.

location_facility: AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire


title: Randomized Prospective Multicentric Study: Radio-chemotherapy and Liver Transplantation Versus Liver Resection to Treat Respectable Hilar Cholangiocarcinoma

acronym: TRANSPHIL

summary:
A prospective, open-label, randomised, multicentre, comparative study in two parallel groups comparing an interventional group with liver transplantation preceded by neoadjuvant radio-chemotherapy and a control group receiving conventional liver and bile duct resection.

The primary endpoint will be overall survival at 5 years in the intent-to-treat population. The secondary endpoint will be recurrence-free survival at 3 years evaluated by CT-scan and tumoral markers (Carcinoembryonic antigen (CAE) and cancer antigen (CA19.9)) in the intent-to-treat population.

The number of subjects necessary is 54 patients (27 x 2): this population will enable the demonstration of a significant difference is 5-year survival rates between the transplanted group and the resected group with a power of 80% and a first-species risk of 5%, under the hypothesis that these survival rates are 70% in the transplanted group and 30% in the resected group.


title: Performance of the New Generation of Sorin Group Brady Leads In a Normal Hospital Practice

acronym: XFine & Beflex

summary:
This observational study is a non-interventional multi-centre, prospective study.

The aim of the study is to evaluate the Sorin Group new passive- and active- fixation pacing leads. We plan to assess the acute and short term lead dislodgment rate (within the first three months following implantation) correlated with the type of lead (active- or passive- fixation). Further, we are collecting data related to leads handling and leads electrical performances

lead_sponsor: LivaNova


acronym: ASTER

summary:
Mechanical thrombectomy (TM) is now validated through 4 randomized controlled trials of high scientific level as the reference treatment of cerebral infarction associated with proximal cerebral occlusion (MR CLEAN, ESCAPE 2014, 2015). These studies have shown for the first time a major decrease (-35%) of disability related to severe cerebral infarction and reduction in mortality. These studies only used thrombectomy devices called stent retriever for obtaining recanalization rates ranging from 58-72% for the 2 largest studies (MR CLEAN, ESCAPE 2014, 2015). This criterion "recanalization" is important because it largely determines the functional prognosis of patients with severe cerebral infarction (Khatri, 2014).

These results are exciting but we can do even better. Indeed, already new thrombectomy devices are available with a special interest for ADAPT (A Direct Aspiration First Pass Technic). This distal suction system, with a high level of endovascular navigability, provides high recanalization rates (> 90%), low morbidity, with a synergistic effect with stent retriever (Turk A, Kowoll 2014 and 2015). To date, these technic (ADAPT) has never been assessed in a randomized controlled trial.

We have previously conducted a comparative observational study between two recanalization strategies by thrombectomy using first-line ADAPT or the most widely used stent retriever. The interventional neuroradiologist could, in case of recanalization failure with the Solitaire system, used another thrombectomy material left to the operator's choice. 244 consecutive patients on two centers (Rothschild Foundation, and Foch Hospital, France) admitted for a cerebral infarction associated with proximal occlusion were included. This is so far the largest series of patients with ADAPT system. The complete recanalization rate was 84% with ADAPT versus 68% with stent retriever (P = 0.006). Unpublished data, Oral presentation at the European Stroke Organization, April 2015). Our research aims to show that a first line strategy of recanalization by thrombectomy using a distal suction system (ADAPT) is superior that the use of a stent retriever.

ReferenceCitation: Maïer B, Robichon E, Bourcier R, Dargazanli C, Labreuche J, Thion LA, Leguen M, Riem R, Desilles JP, Boulouis G, Delvoye F, Hebert S, Redjem H, Smajda S, Escalard S, Blanc R, Piotin M, Lapergue B, Mazighi M; ASTER Trial†. Association of Hypotension During Thrombectomy and Outcomes Differs With the Posterior Communicating Artery Patency. Stroke. 2021 Aug;52(9):2964-2967. doi: 10.1161/STROKEAHA.121.034542. Epub 2021 Jun 17. Erratum in: Stroke. 2021 Aug;52(9):e572.

name: Interventional Neuroradiology Department, Fondation Ophtalmologique A. de Rothschild, Paris, France (B.M., E.R., J.-P.D., F.D., S.H., H.R., S.S., S.E., R.B., M.P., M.M.).

name: Université de Paris, France (B.M., J.-P.D., R.B., M.P., M.M.).

family: Maïer

full_name: Benjamin Maïer

family: Robichon

full_name: Erwan Robichon

given: Erwan

family: Bourcier

full_name: Romain Bourcier

given: Romain

name: Diagnostic and Interventional Neuroradiology Department, Gui de Chauliac Hospital, Montpellier, France (C.D.).

family: Dargazanli

full_name: Cyril Dargazanli

given: Cyril

name: Université de Lille, CHU Lille, ULR 2694 - METRICS: Évaluation des Technologies de Santé et des Pratiques Médicales, France (J.L.).

family: Labreuche

full_name: Julien Labreuche

given: Julien

name: Anesthesiology Department, Fondation Ophtalmologique A. de Rothschild, Paris, France (L.-A.T.).

family: Thion

full_name: Laurie-Anne Thion

given: Laurie-Anne

name: Anesthesiology Department, Foch Hospital, France (M.L.).

family: Leguen

full_name: Morgan Leguen

given: Morgan

name: Anesthesiology Department, Nantes Hospital, France (R.R.).

family: Riem

full_name: Romuald Riem

given: Romuald

family: Desilles

full_name: Jean-Philippe Desilles

given: Jean-Philippe

name: Neuroradiology Department, Tours Hospital, France (G.B.).

family: Boulouis

full_name: Grégoire Boulouis

given: Grégoire

family: Delvoye

full_name: François Delvoye

given: François

family: Hebert

full_name: Solène Hebert

given: Solène

family: Redjem

full_name: Hocine Redjem

given: Hocine

family: Smajda

full_name: Stanislas Smajda

given: Stanislas

family: Escalard

full_name: Simon Escalard

given: Simon

name: Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nantes, Inserm 1087, CNRS, UNIV Nantes (R.B.).

family: Blanc

full_name: Raphaël Blanc

given: Raphaël

family: Piotin

full_name: Michel Piotin

given: Michel

name: Stroke Center, Foch Hospital, France (B.L.).

family: Lapergue

full_name: Bertrand Lapergue

given: Bertrand

family: Mazighi

full_name: Mikael Mazighi

given: Mikael

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Derraz I, Pou M, Labreuche J, Legrand L, Soize S, Tisserand M, Rosso C, Piotin M, Boulouis G, Oppenheim C, Naggara O, Bracard S, Clarençon F, Lapergue B, Bourcier R; ASTER and the THRACE Trials Investigators. Clot Burden Score and Collateral Status and Their Impact on Functional Outcome in Acute Ischemic Stroke. AJNR Am J Neuroradiol. 2021 Jan;42(1):42-48. doi: 10.3174/ajnr.A6865. Epub 2020 Nov 12.

name: on behalf of the ASTER and the THRACE Trials Investigators

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

publisher: American Society of Neuroradiology (ASNR)

publisher_dissemination: American Society of Neuroradiology (ASNR)

publisher_group: American Society of Neuroradiology (ASNR)

publisher_normalized: American Society of Neuroradiology (ASNR)

ReferenceCitation: Ducroux C, Piotin M, Gory B, Labreuche J, Blanc R, Ben Maacha M, Lapergue B, Fahed R; ASTER Trial investigators. First pass effect with contact aspiration and stent retrievers in the Aspiration versus Stent Retriever (ASTER) trial. J Neurointerv Surg. 2020 Apr;12(4):386-391. doi: 10.1136/neurintsurg-2019-015215. Epub 2019 Aug 30.

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

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

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

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

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

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

ReferenceCitation: Rosso C, Blanc R, Ly J, Samson Y, Lehéricy S, Gory B, Marnat G, Mazighi M, Consoli A, Labreuche J, Saleme S, Costalat V, Bracard S, Desal H, Piotin M, Lapergue B; ASTER Trial and Pitié-Salpêtrière Investigators. Impact of infarct location on functional outcome following endovascular therapy for stroke. J Neurol Neurosurg Psychiatry. 2019 Mar;90(3):313-319. doi: 10.1136/jnnp-2018-318869. Epub 2018 Nov 13.

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

ReferenceCitation: Guenego A, Lecler A, Raymond J, Sabben C, Khoury N, Premat K, Botta D, Boisseau W, Maïer B, Ciccio G, Redjem H, Smajda S, Ducroux C, Di Meglio L, Davy V, Olivot JM, Wang A, Duplantier J, Roques M, Krystal S, Koskas P, Collin A, Ben Maacha M, Hamdani M, Zuber K, Blanc R, Piotin M, Fahed R; Aspiration versus STEnt-Retriever (ASTER) trial investigators. Hemorrhagic transformation after stroke: inter- and intrarater agreement. Eur J Neurol. 2019 Mar;26(3):476-482. doi: 10.1111/ene.13859. Epub 2018 Dec 7.

name: Interventional Neuroradiology Department Fondation Ophtalmologique Adolphe de Rothschild Hospital Paris

name: Interventional Neuroradiology Department Toulouse University Hospital Paris

name: Diagnostic Neuroradiology Department Fondation Ophtalmologique Adolphe de Rothschild Hospital Paris France

name: Radiology Department Centre Hospitalier de l'Université de Montréal MontrealCanada

name: Neurology Department Fondation Ophtalmologique Adolphe de Rothschild Hospital Paris France

name: HSHS Neuroscience Center HSHS St John's Hospital Springfield IL USA

name: Vascular Neurology Department Toulouse University Hospital Paris

name: Vascular Neurology Department Foch Hospital Suresnes

name: Diagnostic Neuroradiology Department Toulouse University Hospital Toulouse

name: Biostatistics Fondation Ophtalmologique Adolphe de Rothschild Hospital Paris France

name: the Aspiration versus STEnt‐Retriever (ASTER) trial investigators

title: Hemorrhagic transformation after stroke: inter‐ and intrarater agreement

ReferenceCitation: Fahed R, Ben Maacha M, Ducroux C, Khoury N, Blanc R, Piotin M, Lapergue B; ASTER Trial Investigators. Agreement between core laboratory and study investigators for imaging scores in a thrombectomy trial. J Neurointerv Surg. 2018 Dec;10(12):e30. doi: 10.1136/neurintsurg-2018-013867. Epub 2018 May 14.

ReferenceCitation: Lapergue B, Blanc R, Gory B, Labreuche J, Duhamel A, Marnat G, Saleme S, Costalat V, Bracard S, Desal H, Mazighi M, Consoli A, Piotin M; ASTER Trial Investigators. Effect of Endovascular Contact Aspiration vs Stent Retriever on Revascularization in Patients With Acute Ischemic Stroke and Large Vessel Occlusion: The ASTER Randomized Clinical Trial. JAMA. 2017 Aug 1;318(5):443-452. doi: 10.1001/jama.2017.9644.

name: Department of Stroke Center and Diagnostic and Interventional Neuroradiology, University of Versailles and Saint Quentin en Yvelines, Foch Hospital, Suresnes, France

name: Department of Diagnostic and Interventional Neuroradiology, Rothschild Foundation, Paris, France

name: Department of Diagnostic and Interventional Neuroradiology, Hospices Civils de Lyon, Bron, France

name: University Lille, CHU Lille, Department of Biostatistics, EA 2694–Santé Publique: Epidémiologie et Qualité des Soins, Lille, France

name: Department of Diagnostic and Interventional Neuroradiology, University Hospital of Bordeaux, Bordeaux, France

name: Department of Diagnostic and Interventional Neuroradiology, University Hospital of Limoges, Limoges, France

name: Department of Diagnostic and Interventional Neuroradiology, Hôpital Gui de Chauliac, Montpellier, France

name: Department of Diagnostic and Interventional Neuroradiology, University Hospital of Nancy, Nancy, France

name: Department of Diagnostic and Interventional Neuroradiology, Guillaume et René Laennec University Hospital, Nantes, France

ReferenceCitation: Blanc R, Redjem H, Ciccio G, Smajda S, Desilles JP, Orng E, Taylor G, Drumez E, Fahed R, Labreuche J, Mazighi M, Lapergue B, Piotin M. Predictors of the Aspiration Component Success of a Direct Aspiration First Pass Technique (ADAPT) for the Endovascular Treatment of Stroke Reperfusion Strategy in Anterior Circulation Acute Stroke. Stroke. 2017 Jun;48(6):1588-1593. doi: 10.1161/STROKEAHA.116.016149. Epub 2017 Apr 20. Erratum in: Stroke. 2017 Jun;48(6):e152.


title: A Phase 1/2 Open Label Study Evaluating the Safety and Efficacy of Gene Therapy of the Sickle Cell Disease by Transplantation of an Autologous CD34+ Enriched Cell Fraction That Contains CD34+ Cells Transduced ex Vivo With the GLOBE1 Lentiviral Vector Expressing the βAS3 Globin Gene (GLOBE1 βAS3 Modified Autologous CD34+ Cells) in Patients With Sickle Cell Disease (SCD)

acronym: DREPAGLOBE

summary: The purpose of this study is to evaluate the Safety and Efficacy of Gene Therapy of the Sickle Cell disease by Transplantation of an Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced ex vivo with the GLOBE1 lentiviral vector expressing the βAS3 globin gene (GLOBE1 βAS3 Modified Autologous CD34+ Cells) in Patients with Sickle Cell Disease (SCD)

location_facility: Department of Biotherapy, Necker-Enfants Malades Hospital

intervention_type: Genetic


type: Other Grant/Funding Number

title: Efficacy and Safety of Low-dose IL-2 (Ld-IL-2) as a Treg Enhancer for Controlling Neuro-inflammation in Newly Diagnosed Amyotrophic Lateral Sclerosis (ALS) Patients: A Randomized, Double-blind, Placebo- Controlled, Phase-II Proof of Concept/ Proof of Mechanism Clinical Trial

acronym: MIROCALS

summary:
MIROCALS is a phase II study of ld-IL-2 as a therapeutic agent for ALS. A randomized (1:1), placebo-controlled, double-blind, parallel group trial will be carried out to assess ld-IL-2 safety and clinical efficacy on survival and functional decline in newly diagnosed ALS patients treated for 18 months. Randomization will be stratified according to (i) country (n = 2 levels: UK, France) and (ii) site of onset (n= 2 levels: bulbar vs limb onset).

The primary objective to evaluate the clinical efficacy and safety of the experimental drug (ld IL-2) over an 18 months period in order to establish the proof of concept (PoC) that modifying immune responses through the enhancement of regulatory T cells modifies the rate of ALS disease progression.

ipd_sharing: Yes

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_country:
United Kingdom
France

location_facility: HCL - Hôpital Neurologique P. Wertheimer

location_facility: CHU de Strasbourg - Hôpital de Hautepierre

location_facility: CENTRE HOSPITALIER DE SAINT BRIEUC - Hôpital Yves Le Foll

location_facility: CHRU de Montpellier - Hôpital Gui de Chauliac

location_facility: North-East London and Essex MND Regional Care Centre

location_facility: Salford Royal NHS Foundation Trust, Neurology Dept

location_facility: APHP - Groupe Hospitalier Pitié-Salpetrière

location_facility: Institute of Neurological Sciences, Queen Elizabeth University Hospital

location_facility: Centre for Neuromuscular Diseases - National Hospital of Neurology


title: A Study to Validate a Predictive Questionnaire for Vitamin D Insufficiency in Healthy Adults

summary: The purpose of this clinical study is to evaluate the metrological properties of a questionnaire that aims to identify the vitamin D status in reference to a vitamin D blood dosage.

lead_sponsor: Lesieur

location_facility: Clinical Nutrition Center Naturalpha (CNCN)


title: Comparative Bioavailability Study of a New GFT505 Formulation With the Existing One After 120 mg Single Oral GFT505 Administration and Assessment of the Gender Effect in Young Healthy Male and Female Volunteers Followed by a Single and Multiple Ascending Dose Safety, Tolerability and Pharmacokinetic Study of GFT505 in Overweight or Obese Subjects and in Diabetic Patients

summary:
The Sponsor, Genfit, has developed a new formulation of GFT505 (60 mg). The objective is to compare the relative bioavailability between the new GFT505 formulation (capsule dosed at 60 mg GFT505) and the old GFT505 formulation (capsule dosed at 20 mg GFT505) in healthy male subjects and to assess the impact of gender on this relative bioavailability after administration in male and female subjects.

Using the new formulation, a single and a multiple ascending dose study will be performed in overweight or obese male subjects otherwise healthy whose demographic and physiological characteristics are thought to be closer to those of the target population (Type 2 diabetes). Thereafter, a group of male and female patients with Type 2 diabetes will receive multiple dose administration of GFT505.

lead_sponsor: Genfit

location_facility: SGS Aster S.A.S. - Phase I Clinical Unit


ReferenceCitation: Peyrade F, Bologna S, Delwail V, Emile JF, Pascal L, Fermé C, Schiano JM, Coiffier B, Corront B, Farhat H, Fruchart C, Ghesquieres H, Macro M, Tilly H, Choufi B, Delarue R, Fitoussi O, Gabarre J, Haioun C, Jardin F. Combination of ofatumumab and reduced-dose CHOP for diffuse large B-cell lymphomas in patients aged 80 years or older: an open-label, multicentre, single-arm, phase 2 trial from the LYSA group. Lancet Haematol. 2017 Jan;4(1):e46-e55. doi: 10.1016/S2352-3026(16)30171-5.

family: Peyrade

full_name: Frédéric Peyrade

given: Frédéric

family: Bologna

full_name: Serge Bologna

given: Serge

family: Delwail

full_name: Vincent Delwail

given: Vincent

family: Emile

full_name: Jean François Emile

given: Jean François

family: Pascal

full_name: Laurent Pascal

given: Laurent

family: Fermé

full_name: Christophe Fermé

given: Christophe

family: Schiano

full_name: Jean-Marc Schiano

given: Jean-Marc

family: Coiffier

full_name: Bertrand Coiffier

family: Corront

full_name: Bernadette Corront

given: Bernadette

family: Farhat

full_name: Hassan Farhat

given: Hassan

family: Fruchart

full_name: Christophe Fruchart

family: Ghesquieres

full_name: Herve Ghesquieres

given: Herve

family: Macro

full_name: Margaret Macro

given: Margaret

family: Tilly

full_name: Hervé Tilly

given: Hervé

family: Choufi

full_name: Bachra Choufi

given: Bachra

family: Delarue

full_name: Richard Delarue

given: Richard

family: Fitoussi

full_name: Olivier Fitoussi

given: Olivier

family: Gabarre

full_name: Jean Gabarre

given: Jean

family: Haioun

full_name: Corinne Haioun

given: Corinne

family: Jardin

full_name: Fabrice Jardin

given: Fabrice

journal_name: The Lancet Haematology

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Belgium France

location_facility: Universite Catholique de Louvain Mont Godinne

location_facility: Az Groeninge - Campus Maria'S Voorzienigheid

location_facility: Universite Libre de Bruxelles - Hopital Erasme

title: PHASE II STUDY OF MINI-CHOP PLUS OFATUMUMAB (O) IN NON PREVIOUSLY TREATED PATIENTS AGED OVER 80 YEARS WITH CD 20+ DIFFUSE LARGE B-CELL LYMPHOMA

summary:
This study is a multicentric, phase II, open-label, non-randomized trial evaluating the efficacy of O-miniCHOP in patients aged over 80 years with non previously treated CD20+ diffuse large B-cell lymphoma (age-adjusted IPI=0 to3), stage I, II, III or IV with a performance status ECOG from 0 to 4.

The anticipated study dates (start / end) are: 2010 - 2013. The study will evaluate a cohort of 120 patients (approximately 95 in France, 15 in Belgium, 5 in Switzerland and 5 in Portugal).

Patients will be recruited over 30 months and followed at least one year after the last patient has been included.

The duration of the treatment period is approximately 20 weeks.


title: Effectiveness and Determinants of Effectiveness of Implementation of Tools for the Development of Patient Centred Care at Hospital

acronym: MoSTRA

summary:
A national context for patient centered care development exists in France at hospital with strong support for the implementation of operational patient centered care tools. Patient centered care is a global vision of patient or family management promoting the respect of patient freedom, of patient listening and of patient needs. Patient centered care is an important issue of quality and security of care. The FORAP (Fédération des Organismes Régionaux et territoriaux pour l'Amélioration des Pratiques et des organisations) and the la HAS (High Authority of Health) have developed and validated five tools promoting patient centered care at hospital.

They can be implemented one by one or in association according to hospital situation. Hospitals should identify the association of tools fitting the most to their objectives and the actions already done.

The objectives of the project are to analyse the effectiveness of the implementation of HAS - FORAP tools on the development of patient centred care at hospital and to analyse the individual and organisational determinants of their effectiveness. It focuses on acute care hospitals that have the choice of the combination of tools and that are followed during two years with combined quantitative and qualitative analyses. Quantitative assessment are based on validated indicators on patient satisfaction, patient centred care development and organizational context. Qualitative data collection are realised in each included hospital and combine individual interviews and focus groups including Physicians, nurses and managerial staff.

time_perspective: Cross-Sectional

location_facility:
Clinique Saint Anne
CH intercommunal de Quimper
CH de Vitré
CHD de La Roche Sur Yon
CH de Crest
CH du Haut-Bugey
Hôpital Privé Saint Martin
CHU de Rennes
Clinique Saint Charles
Clinique Saint Vincent
CHU de Bordeaux
CH de Dinan
Centre orthopédique médico-chirurgical
CH de Givors
CH d'Agen
Clinique du Parc
CHU de Caen
Maison de santé Marie Galène
CH de Joigny
Centre François Baclesse
CH de Chambéry
CH Côte de Lumière
CH de Redon
Clinique du Val d'Ouest
CH de St Brieuc
CH de Vannes
Polyclinique Côte Basque Sud
CH de Guingamp


title: Observational Study on the Use of Hypertonic Saline for the Treatment of Bronchiolitis

summary:
In randomized controlled trials, the use of nebulized hypertonic saline in acute bronchiolitis has been reported to improve respiratory distress scores, to reduce length of hospital stay and to show a trend towards lower hospitalization rates.

The investigators aim to verify by an observational study if the rate of hospital admission and the length of hospital stay of infants presenting to the emergency department (ED) with bronchiolitis decreases after the inclusion of 5.85% nebulized hypertonic saline in the treatment strategy of the ED and hospitalization wards.

The investigators will assess the evolution of hospital admission rates and the length of hospital stay in two hospitals that use 5.85% nebulized hypertonic saline for the treatment of bronchiolitis and in two hospital that do not use these nebulizations. If nebulized hypertonic saline is effective in this setting, then the hospitalization rates and length of stay should be lower during the year of hypertonic saline use compared to two previous years when this therapy was not used. These parameters would not be modified in centers that do not use hypertonic saline.

lead_sponsor: Hôpital Armand Trousseau

location_facility:
Hôpital de Versailles
CHI Poissy Saint Germain en Laye
Hôpital Armand Trousseau
Hôpital Robert Debré
Hôpital Jean Verdier


lead_sponsor: Centre Hospitalier Universitaire, Amiens

acronym: TEICOPLANIN

title: Administration of Subcutaneous Teicoplanin in the Treatment of Osteoarticular Infections: Tolerance Study

summary: This is a biomedical research, prospective, mono centric, tolerance study Of the administration of subcutaneous teicoplanin in the treatment of osteoarticular infections.


title: The Guarding Reflex Anal, Study of the Modulation Function of Rectal Distension

summary:
The term Guarding Reflex refers to a progressive, involuntary increase in the external urethral sphincter activity during bladder filling.This is a mechanism of continence, preventing from unwanted urine leakage in situation of stress.

Anal continence is essential, and any impairment of this function can have a severe impact on quality of life. Anal continence at rest is mainly insured by the tone of the internal anal sphincter. The external anal sphincter activity during gradually rectal filling is continuous and varies according to the volume of rectal distension.

During an effort, or a cough, the increasing intra-abdominal pressure is transmitted to the rectum. Increased intra-abdominal pressure during an expiratory against resistance effort proportionally increases the response of the external anal sphincter. The reflex contraction of the EAS is an active mechanism under spinal control, and result in a stronger contraction than a voluntary one. This reflex contraction is the equivalent of "Guarding Reflex" and provides part of the continence in situation of stress.

The main purpose of this study is to research a correlation between the ano rectal distension volume and the external anal sphincter response to a stress.

Patient over eighteen years old, consulting for anorectal manometry examination in order to explore anorectal disorders are included.

Age, sex, ano rectal symptoms, treatments, past history, manometrics data, area under the curve for electromyography activity of the EAS and intercostal muscles during cough with a Valsalva effort are recorded. Slope curve representing the EAS response to stress according to the intercostal activity reflecting cough (intensity response curve) effort are calculated.

The protocol consists in distending the rectum at four different volumes. For each volume, the patient is asked to cough three times gradually, and perform a Valsalva effort three times gradually.

Primary outcome is the difference in curve slope (intensity response curves) between empty rectum and maximal tolerable volume at cough Secondary outcomes are the differences in curve slope between each volume of distension at cough, and Valsalva type effort.

ipd_sharing: Undecided

lead_sponsor: Gérard Amarenco

location_facility: Department of neuro-urology, hôpital Tenon


title: Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection

summary: Withings Move ECG watch is designed to record ECG and detect automatically atrial fibrillation. The aim of this study is to validate the performance of Move ECG watch to detect atrial fibrillation compared to a reference 12-lead ECG.

lead_sponsor: Withings

location_facility:
Hopital Europeen Georges Pompidou
Institut Cœur Paris Centre Turin
Centre Cardiologique du Nord

intervention_type: Diagnostic Test


title: Validation Study of the Watch HWA09 and Its Softwares ECG-SW1 and PPG-SW1 for the Detection of Atrial Fibrillation

acronym: WEFA

summary: The proposed clinical study aims to validate the diagnostic performance, compared to a reference ECG, of the ECG-SW1 software and the PPG-SW1 software integrated into the HWA09 watch developed by Withings for the automatic identification of atrial fibrillation (AF).

ipd_sharing_description: Individual patient data (IPD) are considered as confidential in this study. After the end the final quality control, the database will be frozen and all the IPD will be archived .


title: Dose-finding, Safety, Pharmacokinetic and Pharmacodynamic Study of AVE1642, an Anti-Insulin-like Growth Factor-1 Receptor (IGF-1R/CD221) Monoclonal Antibody, Administered as Single Agent and in Combination With Other Anti Cancer Therapies (Sorafenib or Erlotinib) in Patients With Advanced Liver Carcinoma

summary:
The primary objective of the study is to select the dose of AVE1642 to be administered in patients with liver carcinoma not eligible for local treatment.

The secondary objectives of the study are:

To evaluate the safety profile of AVE1642 as single agent and the safety profile of combinations with other anti-cancer therapies of interest in liver carcinoma , including detection of immunogenicity.
To evaluate pharmacokinetics and pharmacodynamics profiles of AVE1642 as single agent or any PK interactions when given in combination with other anti-cancer therapies.
To assess the preliminary clinical activity in terms of response rate (Complete response + Partial response), duration of responses, stabilisation rate and duration of stabilisation, according to RECIST criteria.
To assess the biological activity at the tumor level.

status: Terminated

lead_sponsor: Sanofi


title: Effect of Bladder Filling on Rectal Contractions During Cystometry

summary:
Increasing knowledge on rectal motility and bladder-rectum cross-talk has been published in recent years. However, whether bladder filling factors during multichannel urodynamic studies affect rectal contraction (RC) parameters has not been studied.

The primary aim of this study is to assess the impact of bladder filling and desire to void on rectal contraction amplitude or frequency.

Secondary objectives are to determine any significant change in rectal parameters depending on clinical and urodynamic factors or treatment.

All patients referred for urodynamic assessment and with studies positive for rectal contractions as defined by the international continence society (ICS) will be included. Abdominal pressure will be measured using a T-doc air charged abdominal catheter inserted 10 cm from the anal margin. Standardized urodynamic evaluation will be conducted following ICS guidelines.

Mean amplitude, maximal amplitude (cmH20) and mean frequency of rectal contractions on all urodynamic studies will be visually measured on the recording software and compared depending on bladder sensation (First Desire to void (FDV), Strong Desire to Void (SDV) and filling volume (200ml, 400ml).

Demographic data (age, sex, BMI), underlying neurological disease, clinical symptoms, and scores (Neurogenic Bladder Symptom Score, Bristol Score, Cleveland Score), urodynamic parameters and treatments will be collected. Time since last defecation and meal will also be collected.

This prospective observational study will be conducted in a Neuro-Urology department of a French university hospital. All the patients included are referred for multichannel urodynamic assessment.

location_facility: department of Neuro-Urology, Hôpital Teno


title: Is the Severity of Urinary Disorders Related to Falls in People With Multiple Sclerosis

summary:
Falls are a common problem in people with multiple sclerosis (PwMS) and can lead to severe consequences (trauma, fear of falling, reduction of social activities). Prevention of falls is one of the priority targets of rehabilitation for PwMS and walking difficulties, which can result of different factors (motor impairment, ataxia, sensitive disorders, fatigability…). Urinary incontinence has been evoked as predictive of falls. But lower urinary tract symptoms (LUTSs) are frequent in PwMS, the prevalence of LUTSs is high (32-96.8%) and increases with MS duration and severity of neurological deficiencies and disabilities. Overactive bladder (OAB) is the most common symptom. Despite its high prevalence and impact on quality of life, the severity of LUTSs has never been studied as specific risk factor of falling. However, urinary urgency and urinary incontinence could lead to precipitation and thus could increase the risk of falling in these patients.

The aim of the study was to assess the relationship between severity of LUTSs and risk of falling in PwMS.

Patients were asked about the number of falls in the past three months and in the past year, and the circumstances in which they occurred (frequency, home, outdoors, going to void, during urinary urgency, nocturia). Severity of LUTSs were assessed by the Urinary Symptoms Profile (USP) Score and patient were classified as with or without urinary incontinence. Number of micturition by night were specifically asked. To take into account motor difficulties and fear of falling, other clinical evaluations were done. The impact of MS on walking was assessed by the 12-Item Multiple Sclerosis Walking Scale (MSWS12) questionnaire, the Expanded Disability Status Scale score, and by clinical test with the Time to be Ready to Void (TRV). Fear of falling was assessed by a simple question and with Falls Efficacy Scale-International (FES-I) Questionnaire.

The primary aim was to assess the relationship between severity of LUTSs and occurrence of falls during the past 3 months. The primary outcome was the importance of overactive bladder (OAB) symptoms with OAB USP score. The secondary outcomes were the existence of urinary incontinence, the warning time (defined as the time from the first sensation of urgency to voiding or incontinence), the importance of nocturia and the other scores of USP questionnaire (low stream and stress urinary incontinence).

The secondary aims were to look for the relationship between severity of LUTSs and occurrence of falls during the past year, and to assess the relationship between falls and the classical risk factors of falls.

ReferenceCitation: Hentzen C, Villaumé A, Turmel N, Chesnel C, Le Breton F, Haddad R, Amarenco G. Are falls in people with multiple sclerosis related to the severity of urinary disorders? Ann Phys Rehabil Med. 2021 Jul;64(4):101452. doi: 10.1016/j.rehab.2020.10.006. Epub 2020 Dec 5.

family: Hentzen

full_name: Claire Hentzen

given: Claire

family: Villaumé

full_name: Anaïs Villaumé

given: Anaïs

family: Turmel

full_name: Nicolas Turmel

given: Nicolas

family: Chesnel

full_name: Camille Chesnel

given: Camille

family: Le Breton

full_name: Frédérique Le Breton

given: Frédérique

family: Haddad

full_name: Rebecca Haddad

given: Rebecca

family: Amarenco

full_name: Gérard Amarenco

given: Gérard

journal_name: Annals of Physical and Rehabilitation Medicine

repository_normalized: HAL

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

location_facility: department of Neuro-Urology, Hôpital Tenon


title: Effect of Need to Void on Rectal Sensory Function in Multiple Sclerosis, a Manometric Study

summary:
Multiple sclerosis causes demyelinating lesions, which can induce multiple symptoms. Ano-rectal avec urinary disorders are frequent due to specific lesions in inhibitor/activator encephalic centers, or interruption on medullary conduction. It seems to be evident that anorectal and urinary disorders are link, because of similar anatomic ways and control process.

To our knowledge several studies test the effect of rectal distension and bladder sensory function but only one study examined the effect of bladder filling on rectal sensitivity on healthy people. The effect of bladder filling on rectal sensory function in patient with neurological disease stay unknown, while dysfunction often occur concomitant, and therapeutic actions in one organ may influence function of the other.

Anorectal manometry is the gold standard for the evaluation of rectal sensory function and the volume of constant sensation to need to defecate is reported in literature as the most reproducible measure.

Primary aim is to assess the effect of need to void on volume of constant sensation to need to defecate in multiple sclerosis with anorectal symptoms. Secondary aim is to identify the effect of need to void on modulation of rectoanal inhibitory reflex (RAIR) and external anal sphincter resting pressure.

Patient with multiple sclerosis over 18 years old, consulting for anorectal disorders in a tertiary center, with an indication to realize an anorectal manometry are included.

History and treatment, height, weight, Expanded Disability Status Scale (EDSS), anorectal and urinary symptoms severity by Bristol, Neurogenic Bowel Dysfunction (NBD), Cleveland, Kess, Urinary Symptom Score (USP) scores, and last urodynamic data are recorded. Patient are asked to drink water until they feel a strong need to void, for which they would go to urinate at home. 3 void volume with portable sonography are done, and the higher is recorded.

Anorectal manometries are realized by the same doctor, in a specific place, with calm. Before the manometric examination, thermal and vibratory sensory thresholds on the right hand are collected. The patient is then placed in a left lateral position. Then the anorectal manometry's catheter is inserted and collect of the external anal sphincter resting pressure begins. Then the investigator proceed to search for RAIR by 5 brief distensions of the intrarectal balloon with increasing volumes of 10 mL from 10 mL to 50 mL. Finally, the investigator collect the threshold volumes of perception, need and maximum tolerable by gradually distending the intra-rectal balloon to 5 mL/s from 0 mL to 300 mL. Toilets are just next to the table of examination.

Next, patient can urinate. 3 post void residual volume with portable sonography are done, and the higher is recorded.

The same tests are realized after urinate, in the same order. After the classical complete manometry was performed.

Primary outcome is the volume of constant sensation to need to defecate Secondary outcomes are the modulation of RAIR and the external anal sphincter resting pressure. Manometric data are collected.

Influence of age, EDSS, severity of symptoms, manometric data and detrusor overactivity on rectal sensory function will be study in secondary analysis.

ReferenceCitation: Pouyau C, Grasland M, Leroux C, Chesnel C, Turmel N, Sheikh Ismael S, Le Breton F, Amarenco G, Hentzen C. Relationship between desire to void and bladder capacity and rectal sensory function in patients with multiple sclerosis and anorectal disorders. Neurourol Urodyn. 2020 Apr;39(4):1129-1136. doi: 10.1002/nau.24330. Epub 2020 Mar 12.

name: Sorbonne Université, GRC 001, GREEN Groupe de Recherche Clinique en Neuro‐Urologie, AP‐HP, Hôpital Tenon Paris France

family: Pouyau

full_name: Camille Pouyau

family: Grasland

full_name: Matthieu Grasland

given: Matthieu

family: Leroux

full_name: Camille Leroux

family: Sheikh Ismael

full_name: Samer Sheikh Ismael

given: Samer

full_name: Frederique Le Breton

given: Frederique

journal_name: Neurourology and Urodynamics


title: Study of Early Closure of Temporary Loop Ileostomy After Elective Rectal Resection With Low Pelvic Anastomoses

summary: We conducted a prospective randomized study to evaluate the results of early closure of temporary loop ileostomy at eight days in comparison with late closure at two months, after elective rectal resection with low pelvic anastomoses.

ReferenceCitation: Alves A, Panis Y, Lelong B, Dousset B, Benoist S, Vicaut E. Randomized clinical trial of early versus delayed temporary stoma closure after proctectomy. Br J Surg. 2008 Jun;95(6):693-8. doi: 10.1002/bjs.6212.

name: Department of Colorectal Surgery, Pôle des Maladies de l'Appareil Digestif, Beaujon Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Clichy, France

family: Alves

full_name: A Alves

given: A

family: Panis

full_name: Y Panis

given: Y

name: Department of Digestive Surgery, Paoli-Calmette Institute, Marseille, Clichy, France

family: Lelong

full_name: B Lelong

given: B

name: Department of Digestive Surgery, Cochin Hospital, AP-HP, Paris France

family: Dousset

full_name: B Dousset

name: Department of Digestive Surgery, Ambroise Paré Hospital, AP-HP, Boulogne, France

family: Benoist

full_name: S Benoist

given: S

name: Department of Digestive Surgery, Clinical Research Unit, Lariboisière Hospital, AP-HP, Université Denis Diderot Paris 7, Paris, France

family: Vicaut

full_name: E Vicaut

given: E

journal_name: British Journal of Surgery

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Cochin - Service de Chirurgie Digestive

location_facility: Hôpital Lariboisière - Service de Chirurgie Digestive

location_facility: Hôpital AMBROISE PARE - Service de Chirurgie Digestive


title: Vacuum Device for Hemostasis in Obstetrics and Gynecology: Proof of Concept Study in the Post Partum Hemorrhage

acronym: HEMOGYN

summary:
The postpartum hemorrhage (PPH) is the major complication of the delivery. In clinical practice, if after giving birth, the placenta is not expelled naturally, an active management should be triggered. Escalating therapy after obstetric maneuvers (placenta, uterus, examination of the birth canal), begins with uterotonic treatments for invasive treatments lead to embolization, vessel ligation and hysterectomy. However, the morbidity of these techniques and the desire to preserve fertility required to devise new therapeutic solutions, which have recently led to the development of an innovative medical device intrauterine hemostasis.

The postpartum haemorrhage are mainly the result of weak and bleeding from the surface corresponds to the placental insertion, which is no longer localized. With the innovative medical device, our main hypothesis is that the uterine walls will append to the walls of the cup after depressurization of the latter. The actuation of the suction cup will lead to aspiration of all sides of the uterus (it is mostly the anterior and posterior that are important). The suction cup is flexible to adapt to the size of the uterus in order to be placed and removed easily from the uterine cavity.

primary_purpose: Health Services Research

lead_sponsor: AdministrateurCIC


title: Fertility After Myomectomy Versus Uterine Artery Embolization for Symptomatic Uterine Fibroids

summary:
Purpose of this study:

To establish the superiority of myomectomy versus Uterine Artery Embolization, in women with multiple symptomatic fibroids and no other infertility factor, seeking to conceive.

ReferenceCitation: Gupta JK, Sinha A, Lumsden MA, Hickey M. Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database Syst Rev. 2012 May 16;(5):CD005073. doi: 10.1002/14651858.CD005073.pub3. Review. Update in: Cochrane Database Syst Rev. 2014;(12):CD005073.

ReferenceCitation: Torre A, Paillusson B, Fain V, Labauge P, Pelage JP, Fauconnier A. Uterine artery embolization for severe symptomatic fibroids: effects on fertility and symptoms. Hum Reprod. 2014 Mar;29(3):490-501. doi: 10.1093/humrep/det459. Epub 2014 Jan 15.

ReferenceCitation: Mara M, Maskova J, Fucikova Z, Kuzel D, Belsan T, Sosna O. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):73-85. Epub 2007 Oct 18.

location_facility: Département de Médecine de la Reproduction, Centre Hospitalier Régionnal Universitaire de Montpellier


title: Evaluation of Cerebrospinal Fluid Flow by MRI in Adolescent Idiopathic Scoliosis, From Its Signaling Through the Study of Trunk Graviception and Proprioception

acronym: MEDULLOSCOL

summary:
Adolescent Idiopathic Scoliosis (AIS) is the most frequent spinal deformity in adolescence, but its etiology remains unknown. Recent publications suggest a link between ciliopathy and AIS. More specifically a modification of the cerebro-spinal fluid (CSF) flow by ciliary dysfunction could be at the origin of a scoliotic deformity.

This study aims to compare the CSF flow measured by magnetic resonance imaging (MRI) in an AIS group and a control group.

lead_sponsor: Lille Catholic University

location_facility: GHICL Hôpital Saint Philibert, service d'Imagerie Médicale

intervention_type: Radiation


title: Modelling Interface Pressure Applied by Superimposed Compression Bandages

summary: The aim of the study is to measure and model interface pressure applied on the lower leg of patients at risk of veinous thrombosis, by different bandage combinations, composed of Biflex 16 (Thuasne) and/or Rosidal K (Lohmann & Rauscher). The patient specific model should better predict the interface pressure distribution than Laplace's Law.

ReferenceCitation: Chassagne F, Helouin-Desenne C, Molimard J, Convert R, Badel P, Giraux P. Superimposition of elastic and nonelastic compression bandages. J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):851-858. doi: 10.1016/j.jvsv.2017.07.006.

family: Chassagne

full_name: Fanette Chassagne

given: Fanette

family: Helouin-Desenne

full_name: Clothilde Helouin-Desenne

given: Clothilde

family: Molimard

full_name: Jérome Molimard

given: Jérome

family: Convert

full_name: Reynald Convert

given: Reynald

family: Badel

full_name: Pierre Badel

given: Pierre

family: Giraux

full_name: Pascal Giraux

given: Pascal

journal_name: Journal of Vascular Surgery: Venous and Lymphatic Disorders

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

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

lead_sponsor: Thuasne

location_facility: Service de Médecine Physique et de Réadaptation, CHU Bellevue


title: Effect of a Musical Intervention in the Intensive Care Unit During the Implantation of a Central Venous Access or a Dialysis Catheter: A Prospective, Randomized Pilot Study

acronym: MUSIC-CAT

summary:
Intensive care unit patients who have to undergo central venous catheter insertion and are able to hear explanations and to gave consent, will be randomized to either usual care during catheter insertion or to a musical intervention added to usual care.

The primary objective will be to assess the patient's anxiety just after catheter insertion. Secondary outcome measures will be the patient-reported pain, the duration of catheter insertion, and the need for additional anxiolytic or sedative drugs during catheter insertion.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: FirstCRY Study : Acoustic Analysis of the First Babies Crying in Delivery Room and Adaptation to Extra Uterine Life

acronym: FIRSTCRY

summary:
Interpreting the cry of new-borns is a real challenge not only for perinatal professionals but also for parents, who are confronted daily with those sounds.

The description and the acoustic analysis of baby's cry can allow healthcare professionals to better adapt their care during the first months of life.

Thanks to an objective analysis method as acoustic analysis, the particularities of the first cry should provide us information on the quality of adaptation to ambient air life.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Living in a Precarious Situation With an Autistic Child: What Are the Issues at Stake for Support in Care: Qualitative Study - Monocentric Study

acronym: HaSPrEA

summary: Study the specificities of families in a precarious situation with a child with autism spectrum disorders (ASD) in terms of housing, in order to better support them in the various social spaces and improve collaboration between professionals and parents

study_start_date_type: Anticipated

status: Not yet recruiting


title: Ventilatory Constraints During Exercise in Asymptomatic Versus Symptomatic Patients With Mild COPD

summary:
The current definition of chronic obstructive pulmonary disease (COPD) is based on the presence of persistent airflow obstruction assessed by spirometry. About half of the subjects with mild COPD (i.e. reduced forced expiratory volume in one second (FEV1) on forced vital capacity (FVC) ratio along with normal FEV1] are asymptomatic. Subjects with symptomatic mild COPD have reduced exercise tolerance and abnormal dynamic ventilatory mechanics compared to healthy subjects. The physiological and perceptual responses to exercise of subjects with asymptomatic mild COPD are currently unknown.

The purpose of this study is to assess exercise tolerance, ventilatory constraints on tidal volume expansion and dyspnoea in asymptomatic mild COPD subjects undergoing incremental cycle cardiopulmonary exercise testing (CPET) to the limit of tolerance compared with symptomatic mild COPD and healthy controls.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver

acronym: OSCAR

summary:
Colorectal cancer is the 3rd most common cancer in France and the 2nd cause of death from cancer. Between 30 to 60% of patients develop limited or predominant liver metastases. Surgical resection of these metastases, only curative treatment is not immediately possible in 10-15% of cases. In unresectable patients, current palliative treatments are based on systemic chemotherapy associated or not with the targeted therapies (anti-EGFR (panitumumab), anti-VEGF (bevacizumab)). In this patient population, special attention was paid to intensified treatment regimens in order to improve their efficiency and improving the tumoral response rate, the intensity of the response and its earliness correlate with improved overall and progression-free survival.

The intra-arterial use of oxaliplatin coupled with IV chemotherapy has yielded OR levels of 64% in patients having survived one or more lines of chemotherapy IV and 62% in patients who have progressed on oxaliplatin IV. In addition, the HIA administration of oxaliplatin limits systemic and especially neurological toxicities, thanks to a greater hepatic clearance.

In conclusion, the combination of systemic chemotherapy, targeted therapy and HIAC with oxaliplatin has showed promising efficacy results associated with good tolerance from the first line onwards. Indeed, we can expect from the Phase II recent data, a control rate close to 100%, with high response rates associated with early maturity and depth responses as well as prolonged survival. However, to date, in the absence of randomized trial testing this combination, this strategy does not have sufficient evidence to be integrated in our routine practices, and HIAC remains limited to a few expert centers in treatment catch-up.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Institut de Cancérologie de Bourgogne - GRRECC

location_facility: Centre d'Imagerie médicale du Confluent- IRIS GRIM

location_facility: Hôpial Privé du Confluent Le Confluent Centre Catherine de Sienne

location_facility: Clinique Mutualiste de l'Estuaire - Cité Sanitaire

location_facility: CH Marne La Vallée-Jossigny - Hôpital André Mignot


title: Study of the Subjective Refraction Measured With SiVIEW Software Compared to That Obtained Manually by an Expert. Monocentric Cross-sectional Study

summary:
Main objective

Show that the equivalent sphere refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.

Secondary objectives

Show that the sphere refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.

Show that the cylinder refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.

Show that the visual acuity measurements obtained by the SiVIEW software do not have a significant clinical difference with those obtained by an optometrist expert.

Demonstrate that the report delivered for each eye exam by SiVIEW software is consistent and relevant to a vision health practitioner.

Show that the differences obtained between two eye examination experts are consistent with those found in the literature.

lead_sponsor: SiVIEW

location_facility: Ophthalmological Foundation A. de Rothschild


title: Assessment of Professional Practices in Muscle Rehabilitation of Chronic Hemodialysis

acronym: REHABIMUS

summary: Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of a muscle strengthening program (training against resistance vs endurance training by elliptical bike) during a observational period (12 weeks per program) on frailty, risk of falling, muscle strength and mass, endurance, physical activity, quality of dialysis, nutritional status and neuromuscular sensitivity.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU: Study Protocol for a Randomised Controlled Against Placebo Trial

acronym: BACLOREA

summary:
Background: Alcohol is the leading psychoactive substance consumed in France, with about 15 million regular consumers. The National institute on Alcohol Abuse and Alcoholism (NIAAA) considers alcohol abuse to be more than 14 units of alcohol a week for men and 7 units for women. The specific complication of alcoholism is the alcohol withdrawal syndrome. Its incidence reaches up to 30% and its main complications are Delirium Tremens, restlessness, extended hospital stay, higher morbidity, psychiatric and cognitive impairment. Without appropriate treatment, Delirium Tremens can lead to death in up to 50% of patients.

Methods/Design: This prospective, randomised, controlled study versus placebo will be conducted in eighteen French intensive care units (ICU). Patients with an alcohol intake higher than the NIAAA threshold, under mechanical ventilation, will be included. The primary objective is to determine whether Baclofen is more efficient than placebo in preventing restlessness-related side effects in ICU. Secondary outcomes include mechanical ventilation duration, length of ICU stay, cumulative doses of sedatives and painkillers received within 28 days of ICU admission. Restlessness-related side effects are defined as unplanned extubation, Medical disposal removal, falling out of bed, ICU runaway, immobilisation device removal, self-aggression or towards medical staff. Daily doses of Baclofen/placebo will be guided by creatinine clearance assessment once a day.

Discussion: Restlessness in alcoholic patients is a life-threatening issue in ICUs. BACLOREA is a randomised study assessing the capacity of Baclofen to prevent agitation in mechanically-ventilated patients. Enrolment of 314 patients will begin in June 2016 and is expected to end in December 2019.

ReferenceCitation: Vourc'h M, Garret C, Gacouin A, Lacherade JC, Jonas M, Klouche K, Ferrandiere M, Jaber S, Flet L, Dailly E, Pouplet C, Maamar A, Reignier J, Roquilly A, Feuillet F, Mahe PJ, Asehnoune K; BACLOREA study group. Effect of High-Dose Baclofen on Agitation-Related Events Among Patients With Unhealthy Alcohol Use Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2021 Feb 23;325(8):732-741. doi: 10.1001/jama.2021.0658.

name: Centre Hospitalo-Universitaire de Nantes, Service d’Anesthésie Réanimation Chirurgicale, France

family: Vourc’h

full_name: Mickael Vourc’h

given: Mickael

name: Centre Hospitalo-Universitaire de Nantes, Service de Médecine Intensive Réanimation, France

family: Garret

full_name: Charlotte Garret

given: Charlotte

name: Centre Hospitalo-Universitaire de Rennes, Service de Médecine Intensive Réanimation, France

family: Gacouin

full_name: Arnaud Gacouin

given: Arnaud

name: Centre Hospitalier Départemental Vendée, Service de Médecine Intensive Réanimation, La Roche-Sur-Yon, France

family: Lacherade

full_name: Jean-Claude Lacherade

given: Jean-Claude

name: Centre Hospitalier Général de Saint-Nazaire, Service de Médecine Intensive Réanimation, France

family: Jonas

full_name: Maud Jonas

given: Maud

name: Centre Hospitalo-Universitaire de Montpellier, Service de Médecine-Intensive Réanimation, France

family: Klouche

full_name: Kada Klouche

given: Kada

name: Centre Hospitalo-Universitaire de Tours, Service d’Anesthésie-Réanimation, France

family: Ferrandiere

full_name: Martine Ferrandiere

given: Martine

name: Centre Hospitalo-Universitaire de Montpellier, Service d’Anesthésie-Réanimation, France

family: Jaber

full_name: Samir Jaber

given: Samir

name: Centre Hospitalo-Universitaire de Nantes, Service Pharmacie, France

family: Flet

full_name: Laurent Flet

given: Laurent

name: Centre Hospitalo-Universitaire de Nantes, Service de Pharmacologie Clinique, France

family: Dailly

full_name: Eric Dailly

given: Eric

family: Pouplet

full_name: Caroline Pouplet

given: Caroline

family: Maamar

full_name: Adel Maamar

given: Adel

family: Reignier

full_name: Jean Reignier

given: Jean

family: Roquilly

full_name: Antoine Roquilly

given: Antoine

name: Centre Hospitalo-Universitaire de Nantes, Plateforme de Méthodologie et Biostatistique, France

name: Université de Nantes, INSERM, SPHERE U1246, France

family: Feuillet

full_name: Fanny Feuillet

given: Fanny

family: Mahe

full_name: Pierre-Joachim Mahe

given: Pierre-Joachim

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

journal_name: JAMA

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Vourc'h M, Feuillet F, Mahe PJ, Sebille V, Asehnoune K; BACLOREA trial group. Baclofen to prevent agitation in alcohol-addicted patients in the ICU: study protocol for a randomised controlled trial. Trials. 2016 Aug 19;17(1):415. doi: 10.1186/s13063-016-1539-2.

location_facility: Centre Hospitalier de Bretagne Sud Réanimation Polyvalente Lorient


title: Interventional Multi-Center Post Market Randomized Controlled Open-Label Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Hard to Heal Diabetic Foot Wounds

acronym: KereFish

summary: The KereFish study is a randomized controlled study to study the efficacy of Kerecis Omega3 Wound on deep diabetic ulcers. This study is probably the first in his field: in this one, the Kerecis Omega3 Wound dies are used on the types of wounds for which they are ultimately intended. This study aims to document the cost benefits of earlier closure of severe diabetic wounds, or the change of the deep and chronic wound into a smaller and shallower ulcer, and to radically alter its prognosis. The study, carried out in France, uses the pre-existing home nursing system with the transmission of photographs to the reference centre. The study was largely designed to ensure transparency of the financial calculations involved.

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility:
CHU de Reims - Hôpital Debré
CHU de Caen
CHRU de Strasbourg - Hopital Civil
Hopital Bichat-Claude Bernard
CHU de Dijon - Bocage Sud
CHU de Montpellier
Hotel Dieu Le Creusot
Hôpital de Roubaix - CETRADIM
Hôpital Cochin
CHU de Nantes Hôpital Nord Laennec
CHU de Toulouse Hôpital Rangueil
Centre Hospitalier Sud Francilien


title: USTekinumab in Fistulising Perianal Crohn's Disease (CD): The USTAP CD Study

acronym: USTAP

summary:
Phase IV

Trial design : Multicentre, randomized, double-blind, placebo-controlled study

Population : Moderate to severe Crohn's disease with at least one active perianal fistula track

Investigational treatment : Group 1: Ustekinumab (UST) IntraVenous (IV) induction (6mg/kg) followed by UST SubCutaneous (SC) 90mg every 8 weeks. Group 2: Placebo IV followed by Placebo SC The trial duration for each patient will be 48 weeks.

Trial objective : To evaluate the efficacy and safety of ustekinumab in fistulizing perianal Crohn's disease.

Number of patients : A total of 146 patients will be included in 20 sites in France

Trial duration : First patient in: Q3 2020 - Last patient first visit: Q3 2022 Last patient last visit: Q3 2023

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility: CHU Nîmes - Hôpital Universitaire Caremeau


title: Observance of Long Term Oxygen Therapy in Chronic Inspiratory Disease Patients

summary: Long-term oxygen therapy (LTOT) is the reference treatment for chronic respiratory failure. This treatment is based on the principle of oxygen supplementation via a source to correct hypoxemia in patients. At present, adherence to this treatment is difficult to evaluate (reporting by patients), but the results of the literature show poor LTOT compliance. It is therefore important to accurately measure the oxygen consumption by patients and to understand the factors explaining LTOT compliance. The ultimate aim is to improve our patient management to make them more observant in order to improve the therapeutic efficacy of the treatment.

lead_sponsor: SOS Oxygene Mediterranee


title: Evaluation of Self-management of Patients With Type 1 Diabetes After Education to Functional Insulin Therapy

acronym: EVAUTODIAB

summary: Therapeutic education of patients is a mandatory component of intensive insulin therapy of type 1 diabetes in order to reach optimal safety and efficacy. Used educational methods aim at facilitating patients' autonomy in their own management of diabetes. Therefore, self-management of patient with type 1 diabetes must be systematically assessed in order to evaluate the effectiveness of education programs .The main objective of this prospective controlled randomized monocentric study is to assess the impact of functional insulin therapy on the level of self-management of patients with type 1 diabetes via Confidence In Diabetes Self-care scale (CIDS) test.

location_facility: Lapeyronie Hospital - CHU de Montpellier