title: Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units

acronym: BestCuff

summary: The investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

ReferenceCitation: Jaillette E, Brunin G, Girault C, Zerimech F, Chiche A, Broucqsault-Dedrie C, Fayolle C, Minacori F, Alves I, Barrailler S, Robriquet L, Tamion F, Delaporte E, Thellier D, Delcourte C, Duhamel A, Nseir S. Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial. Trials. 2015 Sep 25;16:429. doi: 10.1186/s13063-015-0955-z.

ReferenceCitation: Jaillette E, Girault C, Brunin G, Zerimech F, Behal H, Chiche A, Broucqsault-Dedrie C, Fayolle C, Minacori F, Alves I, Barrailler S, Labreuche J, Robriquet L, Tamion F, Delaporte E, Thellier D, Delcourte C, Duhamel A, Nseir S; BestCuff Study Group and the BoRéal Network. Impact of tapered-cuff tracheal tube on microaspiration of gastric contents in intubated critically ill patients: a multicenter cluster-randomized cross-over controlled trial. Intensive Care Med. 2017 Nov;43(11):1562-1571. doi: 10.1007/s00134-017-4736-x. Epub 2017 Mar 16.

family: Jaillette

full_name: Emmanuelle Jaillette

given: Emmanuelle

family: Girault

full_name: Christophe Girault

given: Christophe

family: Brunin

full_name: Guillaume Brunin

given: Guillaume

family: Zerimech

full_name: Farid Zerimech

given: Farid

family: Behal

full_name: Hélène Behal

given: Hélène

family: Chiche

full_name: Arnaud Chiche

given: Arnaud

family: Broucqsault-Dedrie

full_name: Céline Broucqsault-Dedrie

given: Céline

family: Fayolle

full_name: Cyril Fayolle

given: Cyril

family: Minacori

full_name: Franck Minacori

given: Franck

family: Alves

full_name: Isabelle Alves

given: Isabelle

family: Barrailler

full_name: Stéphanie Barrailler

given: Stéphanie

family: Labreuche

full_name: Julien Labreuche

family: Robriquet

full_name: Laurent Robriquet

given: Laurent

family: Tamion

full_name: Fabienne Tamion

given: Fabienne

family: Delaporte

full_name: Emmanuel Delaporte

given: Emmanuel

family: Thellier

full_name: Damien Thellier

given: Damien

family: Delcourte

full_name: Claire Delcourte

given: Claire

family: Duhamel

full_name: Alain Duhamel

given: Alain

family: Nseir

full_name: Saad Nseir

given: Saad

journal_name: Intensive Care Medicine

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Lille

location_facility: ICU, Salengro Hospital, University Hospital of Lille


title: Dose Intensification Phase II Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis. TICE Protocol : Paclitaxel and Ifosfamide Followed by Carboplatine and Etoposide Intensification With Individual Carboplatine Dose Adjustment.

acronym: TICE

summary:
Not randomized, multicentric, national phase II trial estimating the efficacy of an intensification protocol in patients with refractory germ cell tumors with relapse and bad prognosis.

Treatment consists in two Paclitaxel and Ifosfamide intensification cycles followed by three Carboplatine and Etoposide high dose cycles. The point is the individual Carboplatine adjustment to take into account inter-individual patients variability.

This adaptation allow to control each patient plasmatic exposition to avoid both inacceptable toxicities (such as ear toxicity) and a low exposition losing then the benefit of this high dose protocol.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Chevreau C, Massard C, Flechon A, Delva R, Gravis G, Lotz JP, Bay JO, Gross-Goupil M, Fizazi K, Mourey L, Paci A, Guitton J, Thomas F, Lelièvre B, Ciccolini J, Moeung S, Gallois Y, Olivier P, Culine S, Filleron T, Chatelut E. Multicentric phase II trial of TI-CE high-dose chemotherapy with therapeutic drug monitoring of carboplatin in patients with relapsed advanced germ cell tumors. Cancer Med. 2021 Apr;10(7):2250-2258. doi: 10.1002/cam4.3687. Epub 2021 Mar 5.

name: Institut Claudius RegaudIUCT‐Oncopole Toulouse France

family: Chevreau

full_name: Christine Chevreau

given: Christine

sequence: first

name: Institut Gustave Roussy Villejuif France

family: Massard

full_name: Christophe Massard

given: Christophe

sequence: additional

family: Flechon

full_name: Aude Flechon

given: Aude

name: Institut de Cancérologie de l’Ouest Centre Paul Papin Angers France

family: Delva

full_name: Rémy Delva

given: Rémy

name: Institut Paoli Calmettes Marseille France

family: Gravis

full_name: Gwenaëlle Gravis

given: Gwenaëlle

family: Lotz

full_name: Jean‐Pierre Lotz

given: Jean‐Pierre

family: Bay

full_name: Jacques‐Olivier Bay

given: Jacques‐Olivier

family: Gross‐Goupil

full_name: Marine Gross‐Goupil

given: Marine

family: Fizazi

full_name: Karim Fizazi

given: Karim

family: Mourey

full_name: Loïc Mourey

given: Loïc

family: Paci

full_name: Angelo Paci

given: Angelo

name: Laboratoire de Pharmacologie ToxicologieCHU Lyon France

family: Guitton

full_name: Jérôme Guitton

given: Jérôme

name: Cancer Research Center of Toulouse (CRCT),Université Paul Sabatier Toulouse France

family: Thomas

full_name: Fabienne Thomas

name: Laboratoire de Pharmacologie Toxicologie CHU Angers France

family: Lelièvre

full_name: Bénédicte Lelièvre

given: Bénédicte

family: Ciccolini

full_name: Joseph Ciccolini

given: Joseph

family: Moeung

full_name: Sotheara Moeung

given: Sotheara

name: Service d'Otoneurologie et ORL Pédiatrique Hôpital Pierre Paul RiquetCHU de Toulouse Toulouse France

family: Gallois

full_name: Yohan Gallois

given: Yohan

family: Olivier

full_name: Pascale Olivier

given: Pascale

family: Culine

full_name: Stéphane Culine

given: Stéphane

family: Filleron

full_name: Thomas Filleron

given: Thomas

family: Chatelut

full_name: Etienne Chatelut

given: Etienne

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cancer Medicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

title: Multicentric phase II trial of TI‐CE high‐dose chemotherapy with therapeutic drug monitoring of carboplatin in patients with relapsed advanced germ cell tumors

location_facility:
Centre Antoine Lacassagne
Centre Léon Bérard
Centre Paul Papin
Hopital TENON
Institut Claudius Regaud
Institut Paoli Calmette
Hopital St André
Institut Val d'aurelle
Institut Bergonié
CHU
Institut Gustave Roussy


title: Assessment of the Efficacy of Omega-3 Fatty Acids Supplementation, Multi-domain Intervention or Their Combination on the Change of Cognitive Functions in Frail Elderly Subjects

acronym: MAPT

summary:
Epidemiological and fundamental research carried out in recent years has highlighted the role played by omega-3 fatty acids in the process of cognitive decline that accompanies advancing age and Alzheimer's disease. In addition, it has been recognized for some years, following several convergent studies on the prevention of cognitive decline, that nutrition, physical exercise, cognitive training and social activities play a significant role in the maintenance of cognitive faculties. At present, there are a number of epidemiological arguments in favour of a protective role of each of these factors taken in isolation. It can be postulated that a multi-domain intervention may potentiate the protective role of omega-3 fatty acids.

The main objective of this study is to assess the efficacy of isolated supplementation with omega-3 fatty acid, an isolated multi-domain intervention (nutrition, physical exercise, cognitive stimulation, social activities), or their combination on the change of cognitive functions in frail elderly subjects aged of 70 years and older over 3 years.

Secondary objectives:

To assess the efficacy of each treatment strategy on the change of functional capacities and the prevention of dependency,
To study the long-term safety and tolerability of V0137,
To study compliance and adhesion to the multi-domain intervention programme,

Ancillary studies :

To assess the impact of an intervention program on brain metabolism in FDG PET (MAPT-NI : : impact of multidomain intervention on brain metabolism (FDG-PET))

To evaluate the impact of preventive strategies (Omega-3 treatment and multidomain intervention ) of MAPT study on brain atrophy (MRI),
To evaluate the presence and density of ß-amyloid in MAPT subjects using AV45 PET scans (MAPT AV45),
To determine if sleep disorders at early stage of Alzheimer 's disease could be predictive of cognitive decline and used as diagnosis tools (Mapt SLEEP)
To evaluate the impact of omega-3 fatty acids on the body composition measured by DXA scans (MAPT-DXA)

design_allocation: Randomized

primary_purpose: Prevention

ReferenceCitation: Lu WH, Giudici KV, Rolland Y, Guyonnet S, Mangin JF, Vellas B, de Souto Barreto P. Associations Between Nutritional Deficits and Physical Performance in Community-Dwelling Older Adults. Front Nutr. 2021 Nov 11;8:771470. doi: 10.3389/fnut.2021.771470. eCollection 2021.

family: Lu

full_name: Wan-Hsuan Lu

given: Wan-Hsuan

family: Giudici

full_name: Kelly Virecoulon Giudici

given: Kelly Virecoulon

family: Rolland

full_name: Yves Rolland

given: Yves

family: Guyonnet

full_name: Sophie Guyonnet

given: Sophie

family: Mangin

full_name: Jean-François Mangin

given: Jean-François

family: Vellas

full_name: Bruno Vellas

given: Bruno

family: de Souto Barreto

full_name: Philipe de Souto Barreto

given: Philipe

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: Frontiers in Nutrition

oa_host_type: publisher

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ReferenceCitation: Raffin J, Rolland Y, He L, Perus L, Mangin JF, Gabelle A, Virecoulon Giudici K, Vellas B, de Souto Barreto P; MAPT/DSA Group. Cross-sectional and longitudinal interaction effects of physical activity and APOE-ε4 on white matter integrity in older adults: The MAPT study. Maturitas. 2021 Oct;152:10-19. doi: 10.1016/j.maturitas.2021.06.010. Epub 2021 Jun 30.

family: Raffin

full_name: Jérémy Raffin

given: Jérémy

family: He

full_name: Lingxiao He

given: Lingxiao

family: Perus

full_name: Lisa Perus

given: Lisa

family: Gabelle

full_name: Audrey Gabelle

given: Audrey

family: Virecoulon Giudici

given: Kelly

journal_name: Maturitas

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Coley N, Coniasse-Brioude D, Igier V, Fournier T, Poulain JP, Andrieu S; ACCEPT study group. Disparities in the participation and adherence of older adults in lifestyle-based multidomain dementia prevention and the motivational role of perceived disease risk and intervention benefits: an observational ancillary study to a randomised controlled trial. Alzheimers Res Ther. 2021 Sep 24;13(1):157. doi: 10.1186/s13195-021-00904-6.

family: Coley

ReferenceCitation: Conejero I, Dubois J, Gutierrez LA, Delrieu J, Arbus C, Garcia M, Lopez-Castroman J, Courtet P, Gabelle A. Amyloid Burden and Depressive Symptom Trajectories in Older Adults at Risk of Developing Cognitive Decline. J Clin Psychiatry. 2021 Aug 3;82(5). pii: 20m13410. doi: 10.4088/JCP.20m13410.

ReferenceCitation: González-Bautista E, de Souto Barreto P, Andrieu S, Rolland Y, Vellas B; MAPT/DSA group (members are listed under 'Contributors'). Screening for intrinsic capacity impairments as markers of increased risk of frailty and disability in the context of integrated care for older people: Secondary analysis of MAPT. Maturitas. 2021 Aug;150:1-6. doi: 10.1016/j.maturitas.2021.05.011. Epub 2021 Jun 4.

ReferenceCitation: He L, de Souto Barreto P, Aggarwal G, Nguyen AD, Morley JE, Li Y, Bateman RJ, Vellas B; MAPT/DSA Group. Plasma Aβ and neurofilament light chain are associated with cognitive and physical function decline in non-dementia older adults. Alzheimers Res Ther. 2020 Oct 8;12(1):128. doi: 10.1186/s13195-020-00697-0.

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

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

ReferenceCitation: Gallini A, Yrondi A, Cantet C, Poncet M, Vellas B, Schmitt L, Andrieu S. Red Blood Cell Omega-3 Fatty Acid Composition and Psychotropic Drug Use in Older Adults: Results from the MAPT Study. J Nutr Health Aging. 2019;23(9):805-812. doi: 10.1007/s12603-019-1252-4.

journal_name: The journal of nutrition, health & aging

ReferenceCitation: Guerville F, de Souto Barreto P, Taton B, Bourdel-Marchasson I, Rolland Y, Vellas B; Multidomain Alzheimer Preventive Trial (MAPT)/Data Sharing Alzheimer (DSA) Group. Estimated Glomerular Filtration Rate Decline and Incident Frailty in Older Adults. Clin J Am Soc Nephrol. 2019 Nov 7;14(11):1597-1604. doi: 10.2215/CJN.03750319. Epub 2019 Oct 18.

name: for the Multidomain Alzheimer Preventive Trial (MAPT)/Data Sharing Alzheimer (DSA) Group

journal_name: Clinical Journal of the American Society of Nephrology

ReferenceCitation: Gabelle A, Gutierrez LA, Jaussent I, Navucet S, Grasselli C, Bennys K, Marelli C, David R, Andrieu S, Berr C, Vellas B, Dauvilliers Y. Excessive Sleepiness and Longer Nighttime in Bed Increase the Risk of Cognitive Decline in Frail Elderly Subjects: The MAPT-Sleep Study. Front Aging Neurosci. 2017 Sep 28;9:312. doi: 10.3389/fnagi.2017.00312. eCollection 2017.

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

ReferenceCitation: Andrieu S, Guyonnet S, Coley N, Cantet C, Bonnefoy M, Bordes S, Bories L, Cufi MN, Dantoine T, Dartigues JF, Desclaux F, Gabelle A, Gasnier Y, Pesce A, Sudres K, Touchon J, Robert P, Rouaud O, Legrand P, Payoux P, Caubere JP, Weiner M, Carrié I, Ousset PJ, Vellas B; MAPT Study Group. Effect of long-term omega 3 polyunsaturated fatty acid supplementation with or without multidomain intervention on cognitive function in elderly adults with memory complaints (MAPT): a randomised, placebo-controlled trial. Lancet Neurol. 2017 May;16(5):377-389. doi: 10.1016/S1474-4422(17)30040-6. Epub 2017 Mar 27.

ReferenceCitation: Gillette-Guyonnet S, Andrieu S, Dantoine T, Dartigues JF, Touchon J, Vellas B; MAPT Study Group. Commentary on "A roadmap for the prevention of dementia II. Leon Thal Symposium 2008." The Multidomain Alzheimer Preventive Trial (MAPT): a new approach to the prevention of Alzheimer's disease. Alzheimers Dement. 2009 Mar;5(2):114-21. doi: 10.1016/j.jalz.2009.01.008.

name: Gérontopôle de Toulouse; Department of Geriatrics; CHU Toulouse; Purpan University Hospital; Toulouse France

name: University Toulouse III; Toulouse France

name: Department of Epidemiology and Public Health, Toulouse; CHU Toulouse; Toulouse France

name: CHU Limoges; Geriatrics Department; Limoges University Hospital; Limoges France

title: Commentary on “A roadmap for the prevention of dementia II. Leon Thal Symposium 2008.” The Multidomain Alzheimer Preventive Trial (MAPT): A new approach to the prevention of Alzheimer's disease

location_facility:
University Hospital Bordeaux
University Hospital of Dijon
University Hospital Limoges
Princesse Grace Hospital
University Hospital Montpellier
University Hospital Toulouse
Chg Montauban
University Hospital of Nice
Regional Hospital
UH of LYON SUD


title: Multicenter Clinical Trial Evaluating the Immunological Response of Vaccination Against Infection by Human Papillomavirus (HPV) 6, 11, 16, 18 in Girls Receiving Immunosuppressive Therapy.

acronym: PRIMAVERA

summary: PRIMAVERA is a Phase IIa clinical trial, with the objective to assess the immunologic response to HPV vaccine in a population of immunocompromised girls. The principal hypothesis is that the immunologic response to tetravalent vaccine in girls who received immunosuppressive treatment is comparable to the immunologic response in girls that are not immunosuppressed.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

ReferenceType: background

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ReferenceCitation: Myers ER, McCrory DC, Nanda K, Bastian L, Matchar DB. Mathematical model for the natural history of human papillomavirus infection and cervical carcinogenesis. Am J Epidemiol. 2000 Jun 15;151(12):1158-71.

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ReferenceCitation: ter Haar-van Eck SA, Rischen-Vos J, Chadha-Ajwani S, Huikeshoven FJ. The incidence of cervical intraepithelial neoplasia among women with renal transplant in relation to cyclosporine. Br J Obstet Gynaecol. 1995 Jan;102(1):58-61.

ReferenceCitation: Fairley CK, Sheil AG, McNeil JJ, Ugoni AM, Disney AP, Giles GG, Amiss N. The risk of ano-genital malignancies in dialysis and transplant patients. Clin Nephrol. 1994 Feb;41(2):101-5.

ReferenceCitation: Kessler M, Jay N, Molle R, Guillemin F. Excess risk of cancer in renal transplant patients. Transpl Int. 2006 Nov;19(11):908-14.

ReferenceCitation: Birkeland SA, Løkkegaard H, Storm HH. Cancer risk in patients on dialysis and after renal transplantation. Lancet. 2000 May 27;355(9218):1886-7.

ReferenceCitation: Vajdic CM, McDonald SP, McCredie MR, van Leeuwen MT, Stewart JH, Law M, Chapman JR, Webster AC, Kaldor JM, Grulich AE. Cancer incidence before and after kidney transplantation. JAMA. 2006 Dec 20;296(23):2823-31.

ReferenceCitation: Nyberg G, Eriksson O, Westberg NG. Increased incidence of cervical atypia in women with systemic lupus erythematosus treated with chemotherapy. Arthritis Rheum. 1981 May;24(5):648-50.

ReferenceCitation: Nath R, Mant C, Luxton J, Hughes G, Raju KS, Shepherd P, Cason J. High risk of human papillomavirus type 16 infections and of development of cervical squamous intraepithelial lesions in systemic lupus erythematosus patients. Arthritis Rheum. 2007 May 15;57(4):619-25.

ReferenceCitation: Tam LS, Chan PK, Ho SC, Yu MM, Yim SF, Cheung TH, Wong MC, Li EK. Natural history of cervical papilloma virus infection in systemic lupus erythematosus - a prospective cohort study. J Rheumatol. 2010 Feb;37(2):330-40. doi: 10.3899/jrheum.090644. Epub 2009 Dec 23.

ReferenceCitation: Kirnbauer R, Hubbert NL, Wheeler CM, Becker TM, Lowy DR, Schiller JT. A virus-like particle enzyme-linked immunosorbent assay detects serum antibodies in a majority of women infected with human papillomavirus type 16. J Natl Cancer Inst. 1994 Apr 6;86(7):494-9.

ReferenceCitation: Joura EA, Kjaer SK, Wheeler CM, Sigurdsson K, Iversen OE, Hernandez-Avila M, Perez G, Brown DR, Koutsky LA, Tay EH, García P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Lehtinen M, Steben M, Bosch X, Dillner J, Kurman RJ, Majewski S, Muñoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Lupinacci LC, Giacoletti KE, Lu S, Vuocolo S, Hesley TM, Haupt RM, Barr E. HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine. Vaccine. 2008 Dec 9;26(52):6844-51. doi: 10.1016/j.vaccine.2008.09.073. Epub 2008 Oct 16.

ReferenceCitation: Garland SM, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter S, Tang GW, Ferris DG, Steben M, Bryan J, Taddeo FJ, Railkar R, Esser MT, Sings HL, Nelson M, Boslego J, Sattler C, Barr E, Koutsky LA; Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE) I Investigators. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med. 2007 May 10;356(19):1928-43.

ReferenceCitation: FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27.

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ReferenceCitation: Ault KA; Future II Study Group. Effect of prophylactic human papillomavirus L1 virus-like-particle vaccine on risk of cervical intraepithelial neoplasia grade 2, grade 3, and adenocarcinoma in situ: a combined analysis of four randomised clinical trials. Lancet. 2007 Jun 2;369(9576):1861-1868. doi: 10.1016/S0140-6736(07)60852-6.

ReferenceCitation: Joura EA, Leodolter S, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Garland SM, Harper DM, Tang GW, Ferris DG, Steben M, Jones RW, Bryan J, Taddeo FJ, Bautista OM, Esser MT, Sings HL, Nelson M, Boslego JW, Sattler C, Barr E, Paavonen J. Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials. Lancet. 2007 May 19;369(9574):1693-702.

ReferenceCitation: Hildesheim A, Herrero R, Wacholder S, Rodriguez AC, Solomon D, Bratti MC, Schiller JT, Gonzalez P, Dubin G, Porras C, Jimenez SE, Lowy DR; Costa Rican HPV Vaccine Trial Group. Effect of human papillomavirus 16/18 L1 viruslike particle vaccine among young women with preexisting infection: a randomized trial. JAMA. 2007 Aug 15;298(7):743-53.

ReferenceCitation: Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, Izurieta HS, Ball R, Miller N, Braun MM, Markowitz LE, Iskander J. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA. 2009 Aug 19;302(7):750-7. doi: 10.1001/jama.2009.1201.

ReferenceCitation: Villa LL, Costa RL, Petta CA, Andrade RP, Paavonen J, Iversen OE, Olsson SE, Høye J, Steinwall M, Riis-Johannessen G, Andersson-Ellstrom A, Elfgren K, Krogh Gv, Lehtinen M, Malm C, Tamms GM, Giacoletti K, Lupinacci L, Railkar R, Taddeo FJ, Bryan J, Esser MT, Sings HL, Saah AJ, Barr E. High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of follow-up. Br J Cancer. 2006 Dec 4;95(11):1459-66. Epub 2006 Nov 21.

ReferenceCitation: Olsson SE, Villa LL, Costa RL, Petta CA, Andrade RP, Malm C, Iversen OE, Høye J, Steinwall M, Riis-Johannessen G, Andersson-Ellstrom A, Elfgren K, von Krogh G, Lehtinen M, Paavonen J, Tamms GM, Giacoletti K, Lupinacci L, Esser MT, Vuocolo SC, Saah AJ, Barr E. Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine. Vaccine. 2007 Jun 21;25(26):4931-9. Epub 2007 Apr 20.

ReferenceCitation: Reisinger KS, Block SL, Lazcano-Ponce E, Samakoses R, Esser MT, Erick J, Puchalski D, Giacoletti KE, Sings HL, Lukac S, Alvarez FB, Barr E. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Pediatr Infect Dis J. 2007 Mar;26(3):201-9.

ReferenceCitation: Levin MJ, Moscicki AB, Song LY, Fenton T, Meyer WA 3rd, Read JS, Handelsman EL, Nowak B, Sattler CA, Saah A, Radley DR, Esser MT, Weinberg A; IMPAACT P1047 Protocol Team. Safety and immunogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine in HIV-infected children 7 to 12 years old. J Acquir Immune Defic Syndr. 2010 Oct;55(2):197-204. doi: 10.1097/QAI.0b013e3181de8d26.

ReferenceCitation: Grabowska K, Wang X, Jacobsson A, Dillner J. Evaluation of cost-precision rations of different strategies for ELISA measurement of serum antibody levels. J Immunol Methods. 2002 Dec 20;271(1-2):1-15.

ReferenceCitation: Dessy FJ, Giannini SL, Bougelet CA, Kemp TJ, David MP, Poncelet SM, Pinto LA, Wettendorff MA. Correlation between direct ELISA, single epitope-based inhibition ELISA and pseudovirion-based neutralization assay for measuring anti-HPV-16 and anti-HPV-18 antibody response after vaccination with the AS04-adjuvanted HPV-16/18 cervical cancer vaccine. Hum Vaccin. 2008 Nov-Dec;4(6):425-34. Epub 2008 Nov 11.

ReferenceCitation: Waterboer T, Sehr P, Michael KM, Franceschi S, Nieland JD, Joos TO, Templin MF, Pawlita M. Multiplex human papillomavirus serology based on in situ-purified glutathione s-transferase fusion proteins. Clin Chem. 2005 Oct;51(10):1845-53. Epub 2005 Aug 11.

ReferenceCitation: Michael KM, Waterboer T, Sehr P, Rother A, Reidel U, Boeing H, Bravo IG, Schlehofer J, Gärtner BC, Pawlita M. Seroprevalence of 34 human papillomavirus types in the German general population. PLoS Pathog. 2008 Jun 20;4(6):e1000091. doi: 10.1371/journal.ppat.1000091.

ReferenceCitation: Mendez F, Munoz N, Posso H, Molano M, Moreno V, van den Brule AJ, Ronderos M, Meijer C, Munoz A; Instituto Nacional de Cancerologia Human Papillomavirus Study Group. Cervical coinfection with human papillomavirus (HPV) types and possible implications for the prevention of cervical cancer by HPV vaccines. J Infect Dis. 2005 Oct 1;192(7):1158-65. Epub 2005 Aug 29.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Montpellier, Hôpital Arnaud de Villeneuve

location_facility: CHU de Bordeaux, Hôpital Pellegrin-Enfants

location_facility: CHU de Lille, Hôpital Jeanne de Flandres

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Unknown


title: Evaluation of the Protective Role of Beta-blockers Prescribed in a Chronic Way on the Arisen of a Severe Septic Syndrome or a Toxic Shock at Patients Having a Community Infection

summary: The severe sepsis (SS) and toxic shock (TS) are both frequent and severe complications of infectious diseases. They are one of the top ten causes of death in industrialized countries. But an eventual protective role of beta-blockers (anti-hypertensive drug) in their occurrence on a community infection has never been studied. The objective of this study is to evaluate this role.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Rennes University Hospital

location_facility: Nancy University Hospital (Jeanne d'Arc)

location_facility: Groupe hospitalier Raymond Poincaré, AP-HP

location_facility: Grenoble University Hospital (A. Michallon)

location_facility: Saint Etienne University Hospital (Bellevue)

location_facility: Rennes University Hospital (Pontchaillou)

location_facility: Limoges University Hospital (Hospital Dupuytren)

status_simplified: Completed


type: Registry Identifier

type: Other Identifier

title: A Phase 2 Study of MK-2206 in Patients With Relapsed or Refractory Diffuse Large-B Cell Lymphoma

summary: This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with relapsed or refractory diffuse large B-cell lymphoma. Akt inhibitor MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

lead_sponsor: National Cancer Institute (NCI)

location_facility:
Hopital Saint Louis
Henri Mondor University-Hospital Center
Hospital Claude Huriez Chru
Centre Hospitalier Lyon-Sud
Institut Paoli Calmettes
Hopitaux de Paris
Centre Leon Berard
Institut Gustave Roussy
Institut Bergonie Cancer Center

intervention_type: Other

lead_sponsor_type: industriel


title: Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography (X-ACT Study)

acronym: X-ACT

summary: The purpose of this study is to demonstrate the (statistical) non-inferiority of iobitridol (Xenetix® 350) when compared to contrast agents with higher iodine concentrations, iopromide (Ultravist® 370) and iomeprol (Iomeron® 400) in terms of coronary CT scan evaluability (quality and interpretability of images).

primary_purpose: Diagnostic

lead_sponsor: Guerbet

location_country: Italy Switzerland France Spain Germany

location_facility: Institut für Radiologie Universitätsklinikum Charité

location_facility: Ospedale A.Perrino U.O. di radiodiagnostica

location_facility: Ospedale civile Maggiore du Verona Borgo

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

intervention_type: Drug


title: Effect of Strict Glycemic Control on Improvement of Exercise Capacities (VO2 Peak, Peak Workload After Cardiac Rehabilitation, in Patients With Type 2 Diabetes Mellitus With Coronary Artery Disease.

summary: The aim of the DARE study is to see whether strict glycemic control during cardiac rehabilitation may ameliorate the improvement of exercise capacities (VO2 peak, peak workload, ventilatory threshold)in patients with type 2 diabetes with coronary artery disease.

ReferenceCitation: Vergès B, Patois-Vergès B, Iliou MC, Simoneau-Robin I, Bertrand JH, Feige JM, Douard H, Catargi B, Fischbach M; DARE Study group. Influence of glycemic control on gain in VO2 peak, in patients with type 2 diabetes enrolled in cardiac rehabilitation after an acute coronary syndrome. The prospective DARE study. BMC Cardiovasc Disord. 2015 Jul 8;15:64. doi: 10.1186/s12872-015-0055-8.

family: Vergès

full_name: Bruno Vergès

family: Patois-Vergès

full_name: Bénédicte Patois-Vergès

given: Bénédicte

family: Iliou

full_name: Marie-Christine Iliou

given: Marie-Christine

family: Simoneau-Robin

full_name: Isabelle Simoneau-Robin

given: Isabelle

family: Bertrand

full_name: Jean-Henri Bertrand

given: Jean-Henri

family: Feige

full_name: Jean-Michel Feige

given: Jean-Michel

family: Douard

full_name: Hervé Douard

given: Hervé

family: Catargi

full_name: Bogdan Catargi

given: Bogdan

family: Fischbach

full_name: Michel Fischbach

given: Michel

currency_apc_doaj: GBP

journal_name: BMC Cardiovascular Disorders

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Rééducation cardiovasculaire CRF Kerpape

location_facility: centre de réadaptation cardiaque "Château le moine"


title: Comparative Study Evaluating the Immunogenicity and Safety of MeMuRu-OKA Vaccine and Measles-mumps-rubella Vaccine (Priorix™) Co-administered With Varicella Vaccine (Varilrix™) in Children Primed With Measles-mumps-rubella Vaccine

summary: As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.

ReferenceCitation: Gillet Y, Steri GC, Behre U, Arsène JP, Lanse X, Helm K, Esposito S, Meister N, Desole MG, Douha M, Willems P. Immunogenicity and safety of measles-mumps-rubella-varicella (MMRV) vaccine followed by one dose of varicella vaccine in children aged 15 months-2 years or 2-6 years primed with measles-mumps-rubella (MMR) vaccine. Vaccine. 2009 Jan 14;27(3):446-53. doi: 10.1016/j.vaccine.2008.10.064. Epub 2008 Nov 11.

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country: Italy Germany France


title: Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure

acronym: setric

summary: The present trial will establish a prospective sequential Allogeneic Stem Cell Transplantation (allo-SCT) treatment combining both salvage chemotherapy and Reduced Intensity Conditioning (RIC) for primary treatment failure Acute Myeloid Leukemia (AML), to which future innovative strategies can be compared.

ReferenceCitation: Mohty M, Malard F, Blaise D, Milpied N, Socié G, Huynh A, Reman O, Yakoub-Agha I, Furst S, Guillaume T, Tabrizi R, Vigouroux S, Peterlin P, El-Cheikh J, Moreau P, Labopin M, Chevallier P. Sequential regimen of clofarabine, cytosine arabinoside and reduced-intensity conditioned transplantation for primary refractory acute myeloid leukemia. Haematologica. 2017 Jan;102(1):184-191. doi: 10.3324/haematol.2016.150326. Epub 2016 Aug 25.

family: Mohty

full_name: Mohamad Mohty

given: Mohamad

family: Malard

full_name: Florent Malard

given: Florent

family: Blaise

full_name: Didier Blaise

given: Didier

family: Milpied

full_name: Noel Milpied

given: Noel

family: Socié

full_name: Gérard Socié

given: Gérard

family: Huynh

full_name: Anne Huynh

given: Anne

family: Reman

full_name: Oumédaly Reman

given: Oumédaly

family: Yakoub-Agha

full_name: Ibrahim Yakoub-Agha

given: Ibrahim

family: Furst

full_name: Sabine Furst

given: Sabine

family: Guillaume

full_name: Thierry Guillaume

given: Thierry

family: Tabrizi

full_name: Resa Tabrizi

given: Resa

family: Vigouroux

full_name: Stéphane Vigouroux

given: Stéphane

family: Peterlin

full_name: Pierre Peterlin

given: Pierre

family: El-Cheikh

full_name: Jean El-Cheikh

given: Jean

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Labopin

full_name: Myriam Labopin

given: Myriam

family: Chevallier

full_name: Patrice Chevallier

given: Patrice

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech

repository_normalized: HAL

publisher: Ferrata Storti Foundation (Haematologica)

location_facility:
Hôpital Edouard Herriot
Nantes University hospital
CHU Toulouse
Paris saint Louis
CHU de Bordeaux
CHU Caen
Institut Paoli Calmette
CHRU de Strasbourg
CHRU lille


title: Cilengitide (EMD121974) in Combination With Irradiation in Children and Young Adults With Newly Diagnosed Diffuse Intrinsic Pontine Glioma: Phase I Study

summary: The aim of the study is to determine the safety of Cilengitide in combination with radiation therapy.

ipd_sharing: No

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Hospitalier Universitaire de Nantes

intervention_type: Radiation


title: Open, Non-controlled, Multicentre, First-in-man Study Using Escalating Doses of LFB-R603 in Patients With Advanced Stage B-Chronic Lymphocytic Leukemia

summary: This study is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of the anti-CD20 monoclonal antibody LFB-R603 in patients with relapsed or refractory B-cell chronic lymphocytic leukemia who have received at least one prior fludarabine-containing regimen.

ReferenceCitation: de Romeuf C, Dutertre CA, Le Garff-Tavernier M, Fournier N, Gaucher C, Glacet A, Jorieux S, Bihoreau N, Behrens CK, Béliard R, Vieillard V, Cazin B, Bourel D, Prost JF, Teillaud JL, Merle-Béral H. Chronic lymphocytic leukaemia cells are efficiently killed by an anti-CD20 monoclonal antibody selected for improved engagement of FcgammaRIIIA/CD16. Br J Haematol. 2008 Mar;140(6):635-43. doi: 10.1111/j.1365-2141.2007.06974.x.

lead_sponsor: Laboratoire français de Fractionnement et de Biotechnologies

location_facility:
Hôpital de Brabois
Clinique Victor Hugo
Hôpital Pontchaillou
Hôpital Hurriez
Institut Paoli Calmettes
Centre Henri Becquerel
Institut Gustave Roussy
CH Lyon Sud
Hôpital Saint Eloi


title: Phase II Study Of Radiotherapy And Capecitabine As Pre-Operative Treatment In Patients With Colorectal Cancer

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well neoadjuvant radiation therapy and capecitabine work in treating patients who are undergoing surgery for stage III or stage IV colorectal adenocarcinoma.

ReferenceType: result

ReferenceCitation: Dupuis O, Vie B, Lledo G, Hennequin C, Noirclerc M, Bennamoun M, Jacob JH. Preoperative treatment combining capecitabine with radiation therapy in rectal cancer: a GERCOR Phase II Study. Oncology. 2007;73(3-4):169-76. doi: 10.1159/000127383. Epub 2008 Apr 16.

family: Dupuis

full_name: Olivier Dupuis

given: Olivier

family: Vie

full_name: Brigitte Vie

given: Brigitte

family: Lledo

full_name: Gérard Lledo

family: Hennequin

full_name: Christophe Hennequin

given: Christophe

family: Noirclerc

full_name: Monique Noirclerc

given: Monique

family: Bennamoun

full_name: Mohamed Bennamoun

given: Mohamed

family: Jacob

full_name: Jacques H. Jacob

given: Jacques H.

journal_name: Oncology

publisher: S. Karger AG

publisher_dissemination: S. Karger AG

publisher_group: S. Karger AG

publisher_normalized: S. Karger AG

title: Preoperative Treatment Combining Capecitabine with Radiation Therapy in Rectal Cancer: A GERCOR Phase II Study

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Centre Medico-Chirurgical Foch
C.H. Senlis
Hopital Notre-Dame de Bon Secours
Centre Regional Francois Baclesse
Hopital Drevon
Intercommunal Hospital
Centre Hospitalier de Mulhouse
Hopital Saint-Louis
Hopital Tenon
Clinique Saint Jean
Hopital Saint - Louis
Centre Jean Bernard


title: Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with inoperable stage IIIB or stage IV non-small cell lung cancer.

location_facility: Centre de Radiotherapie et Oncologie Saint-Faron


title: Phase 3 Safety Study of a Partially Hydrolyzed Rice Protein Formula in Healthy Infants

acronym: Rose

summary: The purpose of this study is to assess growth and global tolerance in healthy new born infants with minor gastrointestinal troubles and/or allergic risk, fed an experimental partially hydrolyzed rice protein infant formula.

lead_sponsor: Sodilac


status: Not yet recruiting

study_start_date_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

primary_purpose: Supportive Care

acronym: FECES

location_facility:
La Pitié Salpêtrière Hospital
Henri Mondor Hospital
Saint Louis Hospital
Tenon Hospital
Raymond Poincaré Hospital
Beaujon Hospital
Bicêtre Hospital
Lariboisière Hospital
Saint Antoine Hospital
Bichat Hospital

type: EudraCT Number

source: euctr

title: Fecal Transplantation to Eradicate Colonizing Emergent Superbugs

summary: Carriage of multi-drug and extensive-drug resistant Gram negative bacteria (MDR-GNB) is associated with an increased risk of infections by these bacteria for the carriers and a high risk of dissemination both in the healthcare setting and the community; the main MDR-GNB reservoir is the fecal microbiota. To prevent both infections and dissemination, effective measures to decolonize subjects carrying MDR-GNB are urgently needed. Animal models, case reports and cohort studies suggest fecal microbiota transplantation (FMT) may be efficient for MDR-GNB decolonization.

status_simplified: Ongoing


title: Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial

acronym: FLAME

summary: Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no treatment able to enhance recovery has yet been validated. Some drugs may have a positive effect when combined with physical rehabilitation. Previous studies have shown a potential effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our group has demonstrated in a small group of stroke patients (n=8) that a single dose of fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind, randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic stroke.

ReferenceCitation: Pariente J, Loubinoux I, Carel C, Albucher JF, Leger A, Manelfe C, Rascol O, Chollet F. Fluoxetine modulates motor performance and cerebral activation of patients recovering from stroke. Ann Neurol. 2001 Dec;50(6):718-29.

ReferenceCitation: Dam M, Tonin P, De Boni A, Pizzolato G, Casson S, Ermani M, Freo U, Piron L, Battistin L. Effects of fluoxetine and maprotiline on functional recovery in poststroke hemiplegic patients undergoing rehabilitation therapy. Stroke. 1996 Jul;27(7):1211-4.

ReferenceCitation: Chollet F, Tardy J, Albucher JF, Thalamas C, Berard E, Lamy C, Bejot Y, Deltour S, Jaillard A, Niclot P, Guillon B, Moulin T, Marque P, Pariente J, Arnaud C, Loubinoux I. Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol. 2011 Feb;10(2):123-30. doi: 10.1016/S1474-4422(10)70314-8. Epub 2011 Jan 7. Erratum in: Lancet Neurol. 2011 Mar;10(3):205.

family: Chollet

full_name: François Chollet

given: François

family: Tardy

full_name: Jean Tardy

family: Albucher

full_name: Jean-François Albucher

given: Jean-François

family: Thalamas

full_name: Claire Thalamas

given: Claire

family: Berard

full_name: Emilie Berard

given: Emilie

family: Lamy

full_name: Catherine Lamy

given: Catherine

family: Bejot

full_name: Yannick Bejot

given: Yannick

family: Deltour

full_name: Sandrine Deltour

given: Sandrine

family: Jaillard

full_name: Assia Jaillard

given: Assia

family: Niclot

full_name: Philippe Niclot

family: Guillon

full_name: Benoit Guillon

given: Benoit

family: Moulin

full_name: Thierry Moulin

family: Marque

full_name: Philippe Marque

family: Pariente

full_name: Jérémie Pariente

given: Jérémie

family: Arnaud

full_name: Catherine Arnaud

family: Loubinoux

full_name: Isabelle Loubinoux

given: Isabelle

journal_name: The Lancet Neurology

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital René Dubos
University Hospital Sainte Anne
University Hospital Rangueil
University Hospital Pitié Salpétrière
University Hospital
University Hospital Purpan


ReferenceCitation: André T, Blons H, Mabro M, Chibaudel B, Bachet JB, Tournigand C, Bennamoun M, Artru P, Nguyen S, Ebenezer C, Aissat N, Cayre A, Penault-Llorca F, Laurent-Puig P, de Gramont A; GERCOR. Panitumumab combined with irinotecan for patients with KRAS wild-type metastatic colorectal cancer refractory to standard chemotherapy: a GERCOR efficacy, tolerance, and translational molecular study. Ann Oncol. 2013 Feb;24(2):412-419. doi: 10.1093/annonc/mds465. Epub 2012 Oct 5.

family: André

full_name: T. André

given: T.

family: Blons

full_name: H. Blons

given: H.

family: Mabro

full_name: M. Mabro

given: M.

family: Chibaudel

full_name: B. Chibaudel

given: B.

family: Bachet

full_name: J-B. Bachet

given: J-B.

family: Tournigand

full_name: C. Tournigand

given: C.

family: Bennamoun

full_name: M. Bennamoun

family: Artru

full_name: P. Artru

given: P.

family: Nguyen

full_name: S. Nguyen

given: S.

family: Ebenezer

full_name: C. Ebenezer

family: Aissat

full_name: N. Aissat

given: N.

family: Cayre

full_name: A. Cayre

given: A.

family: Penault-Llorca

full_name: F. Penault-Llorca

given: F.

family: Laurent-Puig

full_name: P. Laurent-Puig

family: de Gramont

full_name: A. de Gramont

journal_name: Annals of Oncology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

acronym: PIMABI

location_facility: Centre Hospitalier Intercommunal Le Raincy - Montfermeil

title: An Open-label Phase II Trial of Panitumumab Plus Irinotecan for Patients With Advanced Metastatic Colorectal Cancer Without KRAS Mutation (Wild-type) in Third-line Chemotherapy (FOLFOX/XELOX ± Bevacizumab and Irinotecan Alone or FOLFIRI/CAPIRI ± Bevacizumab)

summary:
RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving panitumumab together with irinotecan may kill more tumor cells.

PURPOSE: This phase II clinical trial is studying giving panitumumab together with irinotecan to see how well it works as third-line therapy in treating patients with metastatic colorectal cancer.


title: Outcome Measures and Biomarkers in a Cohort of Spinal Muscular Atrophy Type III/ IV Patients

acronym: SMOB

summary:
The "SMOB" project intends to contribute to fill the gap with reliable and operational outcome measures for type III and IV SMA. In analysing the reliability in imaging (spinal and muscular), electrophysiology analysis (MUNIX), and evaluate the evolution of respiratory function for 50 patients' cohort. The investigators would also take the opportunity to collect biologic samples in order to investigate genetic markers and to assess quality of life of patients by QoL-gNMD questionnaire. The investigators aim to build a database that will allow us to evaluate the effectiveness of a new therapy for adult SMA patients by studying the natural history of the disease. The investigators have distributed the various expertise in Work Package where several centers are involved.

This study is original in that it evaluates the parameters of qMRI and MUNIX in correlation with blood biomarkers. To our knowledge, there are no quantitative MRI (spinal and muscular) biomarkers and/or electrophysiological (MUNIX technique) highlighted for tracking the progression of the adult form of SMA type III and IV. This pilot study would allow identification of predictive markers of the disease progression, and to have validated, sensitive to change and relevant measurement tools that could be used as endpoints in future therapeutic trials.

status: Recruiting

primary_purpose: Other

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Service de Neurologie - CHU Saint-Etienne

location_facility: Service des Maladies Neurologiques Rares

location_facility: Service de Neurologie,Hôpital Raymond-Poincaré

location_facility: Service Laboratoire d'Explorations Fonctionnelles, Hôtel-Dieu, CHU Nantes

location_facility: Service ENMG - Pathologies neuromusculaires, centre de référence en pathologie neuromusculaire Rhône-Alpes, Centre de référence SLA

location_facility: Centre de Référence des Maladies Neuromusculaires - Pôle Neurosciences Cliniques, CHU Nice

location_facility: Centre de référence des Maladies Neuromusculaires,Service de Neurologie, Hôpital de Hautepierre

location_facility: Service de Neurologie et d'explorations fonctionnelles, Hôpital Pierre-Paul Riquet, Place du Docteur Baylac


title: Therapeutic Trial Evaluating Efficacy of Telemedicine (TELESTROKE) in the Management of Patient With Acute Stroke Within 3-hour After Their Symptom Onset Who Are Admitted to a Remote Hospital With no Stroke Unit Facility

summary: The objective is to evaluate decision making of i.v. tPA treatment in acute stroke within 3 hours of symptom onset either remotely via videoconferencing system (investigational arm) beginning of treatment on-site and then transfer to stroke unit vs. decision after immediate transfer to stroke unit (usual care arm). Ten remote hospitals are connected to the BICHAT stroke unit. All patients will have stroke unit care at BICHAT hospital. Primary end-point is rankin 0-1 at 3 months.

ReferenceCitation: Mazighi M, Meseguer E, Labreuche J, Miroux P, Le Gall C, Roy P, Tubach F, Amarenco P. TRUST-tPA trial: Telemedicine for remote collaboration with urgentists for stroke-tPA treatment. J Telemed Telecare. 2017 Jan;23(1):174-180. doi: 10.1177/1357633X15615762. Epub 2016 Jul 9.

name: Department of Neurology and Stroke Centre, Bichat University Hospital, France

name: INSERM LVTS-1148 and Paris-Diderot University, France

family: Mazighi

full_name: Mikael Mazighi

given: Mikael

family: Meseguer

full_name: Elena Meseguer

given: Elena

family: Labreuche

full_name: Julien Labreuche

given: Julien

name: Emergency Department, Compiègne Hospital, France

family: Miroux

full_name: Patrick Miroux

given: Patrick

name: Emergency Department, Argenteuil Hospital, France

family: Le Gall

full_name: Catherine Le Gall

given: Catherine

name: Emergency Department, Provins Hospital, Provins, France

family: Roy

full_name: Patricia Roy

given: Patricia

name: APHP, Département D’Epidémiologie et Recherche Clinique, Hôpital Bichat, France; Univ Paris Diderot, Sorbonne Paris Cité, UMR 1123, France; INSERM, CIC-EC 1425, UMR 1123, France

family: Tubach

full_name: Florence Tubach

given: Florence

family: Amarenco

full_name: Pierre Amarenco

given: Pierre

journal_name: Journal of Telemedicine and Telecare

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

location_facility: BICHAT HOSPITAL Departement of Neurology

location_facility: Hôpital de Lagny sur Marne, Emergency Unit

intervention_type: Procedure


title: Phase II Study of Recurrent Ganglionic Colorectal Cancer Not Accessible By Surgery Treated Using Chemotherapy With Simplified FOLFOX7 Followed By Radiotherapy Combined With 5FU and Oxaliplatin

summary:
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with recurrent metastatic colorectal cancer.

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz


title: Open Label Randomized Controlled Trial of Ultraprotective Ventilation Without Extracorporeal Circulation in Patients With COVID 19 Pneumonia and Moderate to Severe ARDS

summary:
Mortality of COVID-19 pneumonia with acute respiratory distress syndrome (ARDS) is extremely high in preliminary reports amounting to 50-60%. Duration of mechanical ventilation in these patients appears to exceed standard duration of mechanical ventilation in non-COVID-19 ARDS patients, suggesting that COVID-19 patients may be particularly at risk for ventilator-induced lung injury. Treatment of COVID-19 ARDS patients is to date mainly supportive with protective mechanical ventilation (ventilation with low tidal volume (VT) i.e. 6 ml/kg of predicted body weight (PBW) and plateau pressure control below 30 cm H2O).

Mechanical ventilation with VT reduction below 6 ml/kg PBW in ARDS may reduce alveolar strain, driving pressure and hence ventilator-induced lung injury. Investigators recently performed a multicenter pilot study on 34 moderately severe to severe ARDS patients. This study demonstrated that ultraprotective ventilation with ultra-low VT (≤4.2 ml/kg PBW) without extracorporeal circulation may be applied in approximately 2/3 of the patients, with a 4 cmH2O median reduction in driving pressure, at the price of transient episodes of severe acidosis in approximately 1/3 of the patients. Investigators hypothesized that ultraprotective ventilation without extracorporeal circulation may reduce the mortality at day-90 and increase the number of days free from mechanical ventilation (VFD) at day-60, as compared to protective ventilation.

ReferenceCitation: Richard JC, Yonis H, Bitker L, Roche S, Wallet F, Dupuis C, Serrier H, Argaud L, Thiery G, Delannoy B, Pommier C, Abraham P, Muller M, Aubrun F, Sigaud F, Rigault G, Joffredo E, Mezidi M, Terzi N, Rabilloud M. Open-label randomized controlled trial of ultra-low tidal ventilation without extracorporeal circulation in patients with COVID-19 pneumonia and moderate to severe ARDS: study protocol for the VT4COVID trial. Trials. 2021 Oct 11;22(1):692. doi: 10.1186/s13063-021-05665-z.

family: Richard

full_name: Jean-Christophe Richard

given: Jean-Christophe

family: Yonis

full_name: Hodane Yonis

given: Hodane

family: Bitker

full_name: Laurent Bitker

given: Laurent

family: Roche

full_name: Sylvain Roche

given: Sylvain

family: Wallet

full_name: Florent Wallet

given: Florent

family: Dupuis

full_name: Claire Dupuis

given: Claire

family: Serrier

full_name: Hassan Serrier

given: Hassan

family: Argaud

full_name: Laurent Argaud

family: Thiery

full_name: Guillaume Thiery

given: Guillaume

family: Delannoy

full_name: Bertrand Delannoy

given: Bertrand

family: Pommier

full_name: Christian Pommier

given: Christian

family: Abraham

full_name: Paul Abraham

given: Paul

family: Muller

full_name: Michel Muller

given: Michel

family: Aubrun

full_name: Frederic Aubrun

given: Frederic

family: Sigaud

full_name: Florian Sigaud

given: Florian

family: Rigault

full_name: Guillaume Rigault

family: Joffredo

full_name: Emilie Joffredo

given: Emilie

family: Mezidi

full_name: Mehdi Mezidi

given: Mehdi

family: Terzi

full_name: Nicolas Terzi

given: Nicolas

family: Rabilloud

full_name: Muriel Rabilloud

given: Muriel

journal_name: Trials

location_facility: Service de Réanimation Clinique de la Sauvegarde

location_facility: Service de Médecine Intensive Réanimation CHU Gabriel Montpied

location_facility: Service de Réanimation Chirurgicale Hôpital Edouard Herriot Hospices Civils de Lyon

location_facility: Service de Médecine Intensive Réanimation Hôpital Nord - CHU Saint-Etienne

location_facility: Service de Réanimation Polyvalente Centre Hospitalier Lyon Sud Hospices Civils de Lyon

location_facility: Service de Médecine Intensive Réanimation Hôpital Edouard Herriot Hospices Civils de Lyon

location_facility: Service de Médecine Intensive Réanimation Hôpital Michallon - CHU Grenoble Alpes

location_facility: Service de Médecine Intensive Réanimation Hôpital de la Croix Rousse Hospices Civils de Lyon

location_facility: Service de Réanimation Centre hospitalier Annecy Genevois

location_facility: Service de Réanimation Chirurgicale Hôpital de la Croix Rousse Hospices Civils de Lyon

location_facility: Service de réanimation Polyvalente Centre Hospitalier Saint Joseph-Saint Luc


title: Respreeza® Self-administration and Learning Program (AmAREtTI Study- Auto-Administration de Respreeza® et Programme d'apprenTIssage)

acronym: AmAREtTI

summary:
According to the Respreeza® Summary of Product Characteristics, the initial infusions must be administered under the supervision of a health professional experienced in the treatment of alpha-1 antitrypsin deficiency, although subsequent infusions may be administered at home by the person responsible for care or by the patient.

Clinical data on self-administration of Respreeza® are however limited and the grounds for self-administration are left to the assessment of the attending physician, who needs to ensure that appropriate training is delivered.

In this context, CSL Behring would like to run a clinical study in order to assess the effectiveness of a home self-administration learning program in terms of switching to self-administration, and the long term maintenance of this administration.

lead_sponsor: CSL Behring

location_facility:
CHU Angers
CHU Strasbourg
Hospices Civils de Lyon
CHU Bordeaux - Hôpital Haut-Lévèque
CHU Nancy Brabois
Hôpital Saint Joseph
CHU Rennes - Hôpital Pontchaillou
CHU Grenoble-Alpes
CHU Lille
CHRU Tours
Hôpital Bichat-Claude-Bernard


title: Celsior®: Evaluation of an Organ Preservation Solution in Liver Transplantation.

summary: The aim of the study is to determine the efficacy and safety of a preservation solution in liver transplantation. Its efficacy will be compared to the efficacy of other currently used preservation solutions.

ReferenceCitation: Karam G, Compagnon P, Hourmant M, Despins P, Duveau D, Noury D, Boudjema K. A single solution for multiple organ procurement and preservation. Transpl Int. 2005 Jun;18(6):657-63.

ReferenceCitation: Adam R, Cailliez V, Majno P, Karam V, McMaster P, Caine RY, O'Grady J, Pichlmayr R, Neuhaus P, Otte JB, Hoeckerstedt K, Bismuth H. Normalised intrinsic mortality risk in liver transplantation: European Liver Transplant Registry study. Lancet. 2000 Aug 19;356(9230):621-7. Erratum in: Lancet 2001 Apr 21;367(9264):1296.

location_facility: Service de Chirurgie Viscérale et Transplantations - Hôpital Dupuytren

location_facility: Service de Chirurgie Digestive - Hôpital de la Côte de Nacre

location_facility: Service de Chirurgie Générale - Hôpital Edouard Herriot

location_facility: Département de Chirurgie Viscérale - Hôpital Pontchaillou

location_facility: Service de Chirurgie Générale et Digestive - Hôpital Cochin

location_facility: Service de Chirurgie Générale - Hôpital de la Conception

location_facility: Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre

location_facility: Service de Chirurgie Digestive - Hôpital Henri Mondor

location_facility: Chirurgie générale et digestive - Hôpital de la Croix Rousse


title: Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT (Computed Tomography) : the MEKANOS Study

acronym: MEKANOS

summary:
Osteolytic bone metastases and myeloma bone lesions are responsible of long bone and vertebral fractures leading to restricted mobility, surgery and medullar compression that severely alter quality of life and that have a huge medico-economic impact. It has been estimated that 50% of the patients with bone metastasis will encounter bone complications. In the recent years, Bone Oncology Multidisciplinary Meetings have been developed to optimize bone metastases management for each patient in harmony with oncology program.

The assessment of the fracture risk of bone metastasis remains fairly empirical and is based on simple radiography. The Mirel's score for long bones is focused on the extent of cortical defect caused by bone metastasis to identify high-risk patients at risk of fracture during surgery. It is old, little used in routine and lacks sensitivity and specificity. The SINS (Spinal Instability Neoplastic Score) score is the reference for vertebrae. Today, most patients with fracture-risk bone metastasis benefit from a lesion-centered CT scan to better characterize its extent and position but the interpretation remains qualitative. Metastases are considered as an air cavity and the mechanical properties of the tumor are not evaluated. However, many other parameters from the CTscan are available such as cortical or trabecular compartment densitometry, cortical thickness, tumor volume, and position of lysis in the bone.

Based on experience acquired by the service in the evaluation of bone mechanical strength on benign bones, the investigator aim at integrating in the numerical simulation the mechanical properties of both bone and tumor, in order to evaluate the mechanical strength of the pathological bone using a numerical simulation model (finite element analysis-FEA).

MEKANOS will enroll patients with bone metastases of breast, lung, kidney, thyroid or bladder cancer and myeloma lesions affecting the vertebrae or the upper end of the femur.

The resistance obtained will be compared to that of an intact bone. The best predictive parameters of mechanical strength (position of lysis, tumor nature, and bone architecture) will be then determined. Finally, the added value of this technique in relation to historical fragility scores (Mirel's and SINS scores) will be assessed.

The ultimate goal is to provide tools to assess fracture risk and improve the preventive management of bone metastases in harmony with the referring oncologist

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Radiothérapie, Centre Léon Bérard, 28 Prom. Léa et Napoléon Bullukian

location_facility: Service d'oncologie médicale, Institut Curie, 26 rue d'Ulm

location_facility: Service de rhumatologie, CHU de Saint Etienne

location_facility: Service de radiothérapie, Institut Jean-Perrin

location_facility: Service de rhumatologie, CHU de Poitiers

location_facility: Service de Rhumatologie, Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud

location_facility: Service d'onco-rhumatologie, Centre Oscar Lombret

location_facility: Service de Radiologie, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris

location_facility: Service de rhumatologie, CHU de Grenoble


title: Analysis of Emergency Department Visits According to Incidence of Covid-19 in French Metropolis : a One-year Multicenter Observational Retrospective Study.

summary: With lockdown, Emergency Departments (ED) visits decrease, principally for visits unrelated with Covid-19. In this study, the investigators aimed to find a correlation between ED visits and incidence rate of Covid-19 in a French metropolis.

time_perspective: Retrospective

ReferenceCitation: Kain T, Fowler R. Preparing intensive care for the next pandemic influenza. Crit Care. 2019 Oct 30;23(1):337. doi: 10.1186/s13054-019-2616-1. Review.

ReferenceCitation: Sivey P, McAllister R, Vally H, Burgess A, Kelly AM. Anatomy of a demand shock: Quantitative analysis of crowding in hospital emergency departments in Victoria, Australia during the 2009 influenza pandemic. PLoS One. 2019 Sep 24;14(9):e0222851. doi: 10.1371/journal.pone.0222851. eCollection 2019.

ReferenceCitation: Lum ME, McMillan AJ, Brook CW, Lester R, Piers LS. Impact of pandemic (H1N1) 2009 influenza on critical care capacity in Victoria. Med J Aust. 2009 Nov 2;191(9):502-6.

ReferenceCitation: Schanzer DL, Schwartz B. Impact of seasonal and pandemic influenza on emergency department visits, 2003-2010, Ontario, Canada. Acad Emerg Med. 2013 Apr;20(4):388-97. doi: 10.1111/acem.12111.

ReferenceCitation: Yang L, Chan KH, Suen LK, Chan KP, Wang X, Cao P, He D, Peiris JS, Wong CM. Impact of the 2009 H1N1 Pandemic on Age-Specific Epidemic Curves of Other Respiratory Viruses: A Comparison of Pre-Pandemic, Pandemic and Post-Pandemic Periods in a Subtropical City. PLoS One. 2015 Apr 30;10(4):e0125447. doi: 10.1371/journal.pone.0125447. eCollection 2015. Erratum in: PLoS One. 2015;10(7):e0133946.

ReferenceCitation: Kollek D. Response of a community hospital and its emergency department to the H1N1 pandemic influenza. Radiat Prot Dosimetry. 2010 Nov;142(1):12-6. doi: 10.1093/rpd/ncq271. Review.

ReferenceCitation: Kuitunen I, Ponkilainen VT, Launonen AP, Reito A, Hevonkorpi TP, Paloneva J, Mattila VM. The effect of national lockdown due to COVID-19 on emergency department visits. Scand J Trauma Resusc Emerg Med. 2020 Dec 4;28(1):114. doi: 10.1186/s13049-020-00810-0.

ReferenceCitation: Boserup B, McKenney M, Elkbuli A. The impact of the COVID-19 pandemic on emergency department visits and patient safety in the United States. Am J Emerg Med. 2020 Sep;38(9):1732-1736. doi: 10.1016/j.ajem.2020.06.007. Epub 2020 Jun 6.

ReferenceCitation: Westgard BC, Morgan MW, Vazquez-Benitez G, Erickson LO, Zwank MD. An Analysis of Changes in Emergency Department Visits After a State Declaration During the Time of COVID-19. Ann Emerg Med. 2020 Nov;76(5):595-601. doi: 10.1016/j.annemergmed.2020.06.019. Epub 2020 Jun 11.

ReferenceCitation: Kim HS, Cruz DS, Conrardy MJ, Gandhi KR, Seltzer JA, Loftus TM, Fant AL, McCarthy DM. Emergency Department Visits for Serious Diagnoses During the COVID-19 Pandemic. Acad Emerg Med. 2020 Sep;27(9):910-913. doi: 10.1111/acem.14099. Epub 2020 Aug 17.

ReferenceCitation: Giannouchos TV, Biskupiak J, Moss MJ, Brixner D, Andreyeva E, Ukert B. Trends in outpatient emergency department visits during the COVID-19 pandemic at a large, urban, academic hospital system. Am J Emerg Med. 2021 Feb;40:20-26. doi: 10.1016/j.ajem.2020.12.009. Epub 2020 Dec 9.

ReferenceCitation: Baugh JJ, White BA, McEvoy D, Yun BJ, Brown DFM, Raja AS, Dutta S. The cases not seen: Patterns of emergency department visits and procedures in the era of COVID-19. Am J Emerg Med. 2021 Aug;46:476-481. doi: 10.1016/j.ajem.2020.10.081. Epub 2020 Nov 5.

ReferenceCitation: Friedman AB, Barfield D, David G, Diller T, Gunnarson C, Liu M, Vicidomina BV, Zhang R, Zhang Y, Nigam SC. Delayed emergencies: The composition and magnitude of non-respiratory emergency department visits during the COVID-19 pandemic. J Am Coll Emerg Physicians Open. 2021 Jan 14;2(1):e12349. doi: 10.1002/emp2.12349. eCollection 2021 Feb.

ReferenceCitation: Casalino E, Choquet C, Bouzid D, Peyrony O, Curac S, Revue E, Fontaine JP, Plaisance P, Chauvin A, Ghazali DA. Analysis of Emergency Department Visits and Hospital Activity during Influenza Season, COVID-19 Epidemic, and Lockdown Periods in View of Managing a Future Disaster Risk: A Multicenter Observational Study. Int J Environ Res Public Health. 2020 Nov 10;17(22). pii: E8302. doi: 10.3390/ijerph17228302.

ReferenceCitation: Wongtanasarasin W, Srisawang T, Yothiya W, Phinyo P. Impact of national lockdown towards emergency department visits and admission rates during the COVID-19 pandemic in Thailand: A hospital-based study. Emerg Med Australas. 2021 Apr;33(2):316-323. doi: 10.1111/1742-6723.13666. Epub 2020 Nov 2.

ReferenceCitation: Çıkrıkçı Işık G, Çevik Y. Impact of COVID-19 pandemic on visits of an urban emergency department. Am J Emerg Med. 2021 Apr;42:78-82. doi: 10.1016/j.ajem.2021.01.011. Epub 2021 Jan 14.

ReferenceCitation: Butt AA, Azad AM, Kartha AB, Masoodi NA, Bertollini R, Abou-Samra AB. Volume and Acuity of Emergency Department Visits Prior To and After COVID-19. J Emerg Med. 2020 Nov;59(5):730-734. doi: 10.1016/j.jemermed.2020.08.013. Epub 2020 Aug 7.

ReferenceCitation: Delforge C. Analyse de l'évolution de la gravité des patients hospitalisés pour un autre motif au cours de la pandémie COVID-19 au Centre Hospitalier de Roubaix [Internet]. Université de Lille; 2020 [cité 28 mai 2021]. Disponible sur: https://pepite.univ-lille.fr/ori-oai-search/notice/view/univ-lille-30333

ReferenceCitation: Référentiels SFMU - Motifs de recours [Internet]. 2010 [cité 27 mai 2021]. Disponible sur: https://www.sfmu.org/fr/vie-professionnelle/outils-professionnels/referentiels-sfmu/le-thesaurus-des-motifs-de-recours/ref_id/22

ReferenceCitation: Référentiels SFMU - Thésaurus [Internet]. 2009 [cité 27 mai 2021]. Disponible sur: https://www.sfmu.org/fr/vie-professionnelle/outils-professionnels/referentiels-sfmu/le-thesaurus-de-medecine-d-urgence/ref_id/23

lead_sponsor: Centre Hospitalier de Roubaix

location_facility: Emergency Department, GHICL Saint-Vincent

location_facility: Emergency Department, GHICL Saint-Philibert

location_facility: Emergency Department, University Hospital


title: Development of a Severity Assessment Score for Nasosinus Polyposis (PSI Score)

acronym: PSI

summary: nasosinus polyposis (=PNS) is a chronic inflammatory disease of the nasal cavity and sinus cavity with a prevalence of 2 to 4% in the general population. The functional impact of PNS has a major impact on one's quality of life.Medical treatment, nasal irrigations and local glucocorticoids as well as short treatment of oral glucocorticoids have shown a short-term benefit versus placebo. Surgery improves the efficacy of local treatments, but 40% of patients have a recurrence of polyps at 18 months and 20% of patients require a surgery recovery at 5 years. The development of monoclonal antibodies directly targeting the inflammatory way is a real public health issue. Bachert C. et al recently demonstrated the efficacy of Dupilumab (anti-IL-4/13 antibody) injected subcutaneously on the overall symptomatology of PNS. The marketing authorization (AMM) for the first biotherapy to be available soon includes PNS's severe nature and resistance to treatment, although there is no consensus definition or score to characterize this severity. This study aims at developping a score for assessing severity in PNS. We suggest that this assessment strategy could be applied to the PNS. The originality and the innovative character of this project is the statistical modeling behind the creation of the score. Thus, the importance of symptoms, anatomical and biological factors, the estimation of the quality of life of the patients, the level of care use and the number of surgeries all become measurable indicators that are a direct reflexion of the severity and the control of PNS, called latent variables because they cannot be directly measured. To consider this detail, modeling using structural equations seems optimal to develop a severity score (PSI score) of PNS in order to personalize the therapeutic care of patients. Main Objective: To develop a severity score for PNS using latent variable modeling: Polyps Severity Index (PSI)

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Hôpitaux Universitaires de Marseille Conception

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Impact on Quality of Life With Pulmonary RehAbilitation After Pulmonary eMBOlism: RAMBO Study

acronym: RAMBO

summary: Pulmonary Embolism (PE) is a common and serious disease. Indeed, the annual incidence is 1/1000 patients per year and the 3-month mortality is 10%, which is twice that of myocardial infarction. The treatment is based on anticoagulation for at least 3 months. However, after three or six months of anticoagulation, persistent dyspnea and impairment of quality of life are observed in at least 30% of cases. Several mechanisms explain dyspnea and impairment of quality of life after PE, such as residual pulmonary artery obstruction, exercise deconditioning, depressive syndrome or development of a cardio-respiratory pathology. Pulmonary rehabilitation (PR) has been shown to be effective on dyspnea and quality of life and is included in the therapeutic management of chronic respiratory diseases such as Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis. Furthermore, PR is also used after a myocardial infarction. However, PR after PE is still not included in therapeutic management of PE while outpatient management is recommended for the majority of patients after an acute PE episode. Study hypothesis is that PR has the potential to improve quality of life and dyspnea perception in patients who have received anticoagulation for at least 3 months after PE and who present an impairment of quality of life and/or a persistent dyspnea. This study presents several innovative aspects. First, to our knowledge, This study is the first large randomized trial assessing PR at least 3 months after acute symptomatic PE. Only one small randomized trial on 18 patients evaluating the impact of PR after PE has been published; as PR was performed just after the acute phase of PE in this trial, the clinical status improvement observed in this study could not be explained by PR alone, but also by anticoagulation. In this study, the investigators will include 112 patients at least 3 months after PE in order to exclude the bias related to anticoagulation effect. Second, This study is the first large randomized trial. Third, this study is the first that have the potential to demonstrate efficacy and safety of delayed PR after PE in patients with impaired quality of life due to persistent residual dyspnea.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CHU Angers
Centre de santé de Roscoff
Hegp (Ap-Hp)
CHBS Lorient
CH Morlaix
CHU Tours
CHU Saint-Etienne
CHU Brest


title: Postoperative Pain Evaluation After Definitive Root Canal Obturation With Zinc Oxide/Eugenol-type Sealer Containing or Not 1% Prednisolone Acetate - Steroid Anti-inflammatory Agent: a Comparative, Randomized Clinical Trial.

summary:
The study design is a multicentric randomized controlled clinical trial. 238 subjects (teeth) requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (119 in each group).

The aim is to assess the effectiveness and utility of the ancillary drug substance, prednisolone acetate (1%) contained in CORTISOMOL SP (Zinc Oxide/Eugenol-type sealer) to help to decrease the possible postoperative painful reactions after root canal treatment. SEALITE REGULAR, which has a similar formulation except it is prednisolone acetate-free, is used as the comparator sealer.

Procedures of root canal treatment will be conventional and standardized for all investigational centers. The canals will be cleaned, shaped and then obturated using a Zinc oxide/Eugenol-type sealer (CORTISOMOL SP or SEALITE REGULAR) and gutta-percha.

Patients assess their pain for 7 days after permanent root canal obturation.

lead_sponsor: ACTEON Group

location_facility:
Cabinet dentaire
CHU Rennes - Centre de Soins Dentaires

intervention_type: Device


title: Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma. TRUST Study

acronym: TRUST

summary: This study encompasses two multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trials to assess the antitumor activity of bintrafusp alfa in association with doxorubicin

lead_sponsor: Institut Bergonié

location_facility:
Centre Léon Bérard
CHU Poitiers
Centre Georges François Leclerc
Institut Paoli Calmette
IUCT Oncopole
Institut Curie
Institut Gustave Roussy
Institut Bergonie


title: Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis

acronym: BEACH

summary: The objective of this study is to evaluate the predictive nature of the biomarker Porphyromonas catoniae measured at the age of 12 months in the occurrence of colonization with Pseudomonas aeruginosa at 24 months of age in children with cystic fibrosis.

location_facility:
CHRU Rennes
Hôpital Femme-Mère-Enfant Lyon
Hôpital Necker
Hôpital Trousseau
Hôpital Charles Nicolle Rouen
CHRU Angers
CHRU Nantes
CHU Grenoble
Centre de Perharidy
CHRU de Tours
Hôpital des Enfants Bordeaux

intervention_type: Diagnostic Test


title: Randomized Controlled Trial for Efficacy Assessment of a Program of Digital Accompaniment to Optimize Homework Performances and Increase Familial Quality of Life in 9 to 16 Years Children With ADHD" - PANDA-H

acronym: PANDA-H

summary:
Attention Deficit Disorder with or without Hyperactivity (ADHD) is a frequent pathology in children that has important consequences on schooling both in terms of academic level (due to the attentional disorder) and behavior (disruption of the class). ADHD also has an impact on family functioning, which can generate stress and family altercations. The homework period can be a particularly tense time and a source of conflict with the child, which has negative consequences on the family atmosphere, learning efficiency and of course academic success.

The investigators wish to evaluate an innovative digital device (a smartphone application) to accompany the child during homework periods.

lead_sponsor: Nantes University Hospital

location_facility: Berquin Schroder Speranza Delorme Caci Bioulac Fourneret Purpuer


title: Comparison Between Prednisolone and Dexamethasone on D28 Mortality in Patients on Oxygen Therapy, With CoViD-19: Multicenter, Randomized, Open-label Non-inferiority Study

acronym: COPreDex

summary: The aim of the study is to evaluate two differents regimens of corticosteroids (prednisolone versus dexamethasone) on D28 mortality in patients with CoViD 19 pneumonia requiring oxygen supplementation

lead_sponsor: Centre Hospitalier René Dubos

location_facility: Department of Infectious and respiratory Diseases, Hospital Delafontaine

location_facility: Department of Emergency, Hospital Victor Dupouy

location_facility: Department of Pneumology and Infectious Diseases, Hospital of Saint-Quentin

location_facility: Department of Infectious Medicine, Hospital of Gonesse

location_facility: Department of Infectious and Tropical Diseases, Hospital Simone Veil

location_facility: Department of Internal Medicine, Hospital Emile Roux - Le Puy-en-Velay

location_facility: Department of Pneumology and Infectious Medicine, Hospital Carnelle Portes de l'Oise

location_facility: Department of Infectious and Tropical Diseases, Hospital René Dubos,


ReferenceCitation: Eyerich K, Weisenseel P, Pinter A, Schäkel K, Asadullah K, Wegner S, Muñoz-Elias EJ, Bartz H, Taut FJH, Reich K. IL-23 blockade with guselkumab potentially modifies psoriasis pathogenesis: rationale and study protocol of a phase 3b, randomised, double-blind, multicentre study in participants with moderate-to-severe plaque-type psoriasis (GUIDE). BMJ Open. 2021 Sep 13;11(9):e049822. doi: 10.1136/bmjopen-2021-049822.

family: Eyerich

full_name: Kilian Eyerich

given: Kilian

family: Weisenseel

full_name: Peter Weisenseel

given: Peter

family: Pinter

full_name: Andreas Pinter

given: Andreas

family: Schäkel

full_name: Knut Schäkel

given: Knut

family: Asadullah

full_name: Khusru Asadullah

given: Khusru

family: Wegner

full_name: Sven Wegner

given: Sven

family: Muñoz-Elias

full_name: Ernesto J Muñoz-Elias

given: Ernesto J

family: Bartz

full_name: Holger Bartz

given: Holger

family: Taut

full_name: Friedmann J H Taut

given: Friedmann J H

family: Reich

full_name: Kristian Reich

given: Kristian

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

status: Active, not recruiting

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen-Cilag G.m.b.H

location_country: Germany France

acronym: GUIDE

location_facility: ISA - Interdisciplinary Study Association GmbH

location_facility: Zentderma BAG Dres. Ostendorf - Bohm - Jo GbR

location_facility: Harzklinikum Dorothea Christiane Erxleben GmbH - Germnay

location_facility: Polyclinique Reims Bezanne - De Courlancy

location_facility: Universitatsklinikum Schleswig-Holstein - Kiel

location_facility: Company for Medical Study & Service Selters

title: A Phase 3b, Randomized, Double-blind, Parallel Group, Multicenter Study to Evaluate Further Therapeutic Strategies With Guselkumab in Patients With Moderate-to-Severe Plaque-Type Psoriasis

summary: The purpose of this study is to demonstrate that Super-Responders (SRe; defined as psoriasis participants who receive on-label guselkumab treatment until week 20 and respond with a Psoriasis Area and Severity Index score (PASI) = 0 at weeks 20 and 28) maintain control of disease until week 68 with prolonged treatment intervals of 16 weeks (guselkumab 100 mg every 16 weeks).


title: Aprepitant Versus Hydroxyzine in Association With Cytoreductive Treatments for Patients With Myeloproliferative Neoplasia Suffering From Persistent Aquagenic Pruritus.

acronym: APHYPAP

summary: Phase 3, randomized prospective study, double blind-double placebo, testing oral therapies APREPITANT versus HYDROXYZINE in patients followed for myeloproliferative neoplasms and suffering of persistent aquagenic pruritus.

location_facility:
CHU de Caen
Centre Léon Bérard
Centre Hospitalier de Douarnenez
CHU Grenoble Alpes
CHU de Nantes
CHU d'Angers
Hôpital Pontchaillou
Hôpital Yves Le Foll
Centre Hospitalier de Cornouaille
Centre Hospitalier des Pays de Morlaix
CHRU de Brest - Hôpital Morvan


title: Multicentric, Open, Randomized Study Comparing Topical Treatment by Patch of Capsaicin to 8% (Qutenza) to Pregabalin Oral in the Early Treatment of Neuropathic Pain After Primary Surgery for Breast Cancer

acronym: CAPTRANE

summary:
Breast cancer is the most common cancer in women in Europe. Therefore, breast cancer has become a chronic disease and patients need to learn to live with it as well as with the adverse effects related to the disease itself or to the therapies used.

As noted in the third "Plan cancer", pain is a major criterion in the quality of life of patients treated for breast cancer.

Neuropathic pain was defined in 2011 by the international Association for the Study of Pain (I.A.S.P.) as the direct result of a lesion or disease affecting the somato-sensory system.

Surgical treatment is often the first treatment of breast cancer. It can be conservative by performing a partial mastectomy (lumpectomy or quadrantectomy) or non-preservative by total mastectomy.

Intercostobrachial neuralgia (NICB) or Post mastectomy painful Syndrome (MPRR) was first described by Wood in 1978 as "chronic pain beginning immediately or early after a mastectomy" Or a lumpectomy affecting the anterior thorax, armpit and/or arm in its upper half. These post-surgical pains are related to a lesion of the nerves in the breast area.

In particular, the intercostobrachial nerve can be severed, stretched or crushed during surgery.

Post-operative neuropathic pain in patients with breast cancer is underdiagnosed either by general practitioner or in a specialized environment.

The diagnosis of neuropathic pain is performed during examination and clinical examination. Several scales allow to detect neuropathic pain but only the DN4 is recognized to be the most specific and sensitive scale.

Patients do not always express this pain. They do not always reconcile with the surgery. Either because the pain occurs a long time after the surgery, or they find it normal to get hurt. These diagnostic difficulties cause a delay in setting up a suitable analgesic treatment.

However, neuropathic pain responds poorly to common analgesics. Diagnosis, evaluation and early management of neuropathic pain are a priority in order to avoid their chronicization, to improve the quality of life of patients with breast cancer and to enable them to return to work quickly.

We therefore assume that the diagnosis of early neuropathic pain at 2 months of surgery associated with initiation of appropriate topical treatment without the systemic effects of conventional oral treatments, would reduce the incidence of Chronic neuropathic pain 6 months after surgery.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Chu Grenoble
Chd Vendee
Iuct Oncopole
Centre Oscar Lambret
Institut de Cancerologie de L'Ouest
Institut Jean Godinot
Centre Leon Berard
CHU NICE
Institut Curie
Ch Valenciennes
Hopital Saitn Vincent de Paul


title: Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ

summary:
Ductal carcinoma in situ (DCIS) accounts for approximately 20% of newly diagnosed breast cancer cases. Of these women, 20% require radical management in the form of mastectomy because of the extent of the lesions, which most often manifest as diffuse microcalcifications.

This mutilating surgical management contrasts with the excellent prognosis of this pathology and considerably alters the quality of life of patients.

Neoadjuvant hormone therapy has shown its efficacy in hormone-dependent infiltrating ductal carcinomas and offers the possibility of conservative surgery after hormone therapy.

Adjuvant hormone therapy with Tamoxifen or anti-aromatase drugs has shown its efficacy in the prevention of homo or contralateral recurrence.

The HORNEO 01 trial fits perfectly in the current context of surgical de-escalation of ductal carcinomas in situ. The objective of the study is to evaluate the impact of neoadjuvant hormone therapy on the surgical management of extensive DCIS.

location_facility:
Centre Antoine Lacassagne
Institut de Cancérologie de l'Ouest
Institut Curie - Site de Paris
Hopital Saint Joseph
Institut de cancérologie de Montpellier
IUCT-O
Institut Bergonie


title: OPTIBOT: Study Describing the Coverage, Cares and the Fertility of Patients of Less Than 45 Years With a Borderline Ovarian Tumor (BOT)

acronym: OPTIBOT

summary:
Retrospective and prospective multi-center study

Indication: Fertility-sparing surgery for patients with borderline ovarian tumor and fertility

Objectives:

Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumors, the modalities of care and their fertility.
Validation of a nomogram as an information medium to the patients concerned on their chance of alive birth according to their personal characteristics

Origin and nature of the specific data:

Extraction from the database " Tumeurs Malignes Rares de l'Ovaire " (TMRO)
Collection of retrospective further informations in the participating centers
Data collection from the patients (questionnaires) The data will be identified by the TMRO number allocated to every participant of the TMRO study .

Data traffic :

TMRO database extraction for the patients with BOT and corresponding to the inclusion criteria, supplied by Arcagy-Gineco.

The database will be managed by the coordination team in an anonymous way by means of the patient identifiers of the TMRO base.

Enrichment of the base by the anonymous questionnaires filled by the patients and the complementary data transmissions of the centers on anonymised files.

time_perspective: Other

lead_sponsor: Institut Curie

location_facility: Institut de Cancérologie de Lorraine - Centre Alexis VAUTRIN

location_facility: Goupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Centre Hospitalier Intercommunal Poissy - Saint-Germain

location_facility: IUCT Oncopole - Institut Claudius Regaud


title: Early Versus Differed Arterial Catheterization in Critically Ill Patients With Acute Circulatory Failure: A Multicentre, Open-label, Pragmatic, Randomised, Non-inferiority Controlled Trial (EVERDAC Trial)

acronym: EVERDAC

summary:
The objective of the present research is a combination of a one-sided test of non-inferiority and a one-sided test of superiority. A stepped approach will be used to evaluate these hypotheses:

a less invasive intervention (i.e., no indwelling arterial catheter insertion until felt absolutely needed, according to consensual and predefined safety criteria) is non inferior to usual care (i.e., systematic indwelling arterial catheter insertion in the early hours of shock) in terms of mortality at day 28 (non-inferiority margin of 5%).
a less invasive intervention is not only non-inferior but also superior to usual care in terms of mortality.

Multi-centre, pragmatic, randomised, controlled, open, two-parallel group, non-inferiority clinical trial.

ReferenceCitation: Muller G, Kamel T, Contou D, Ehrmann S, Martin M, Quenot JP, Lacherade JC, Boissier F, Monnier A, Vimeux S, Brunet Houdard S, Tavernier E, Boulain T. Early versus differed arterial catheterisation in critically ill patients with acute circulatory failure: a multicentre, open-label, pragmatic, randomised, non-inferiority controlled trial: the EVERDAC protocol. BMJ Open. 2021 Sep 14;11(9):e044719. doi: 10.1136/bmjopen-2020-044719.

family: Muller

full_name: Grégoire Muller

given: Grégoire

family: Kamel

full_name: Toufik Kamel

given: Toufik

family: Contou

full_name: Damien Contou

given: Damien

family: Ehrmann

full_name: Stephan Ehrmann

given: Stephan

family: Martin

full_name: Maëlle Martin

given: Maëlle

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Lacherade

full_name: Jean-Claude Lacherade

given: Jean-Claude

family: Boissier

full_name: Florence Boissier

given: Florence

family: Monnier

full_name: Alexandra Monnier

given: Alexandra

family: Vimeux

full_name: Sylvie Vimeux

given: Sylvie

family: Brunet Houdard

full_name: Solène Brunet Houdard

given: Solène

family: Tavernier

full_name: Elsa Tavernier

given: Elsa

family: Boulain

full_name: Thierry Boulain

given: Thierry

lead_sponsor: University Hospital, Tours


title: Long-term Review of a Cohort of Arthroscopic Bankart Interventions

summary:
Recurrent instability is the most common chronic shoulder pathology of the young and athletic patient. It is a source of functional, sporting and professional disability, and a permanent apprehension to the use of the affected shoulder.

Surgical treatment has been proposed for a long time by the reintegration of the labrum (intervention of Bankart) then by the making of an osteo-muscular stop (intervention of Latarjet).

Like in many domains, surgical techniques have evaluated towards the search for endoscopic alternatives to open surgery, more deleterious.

Bankart's intervention has been performed arthroscopically since the 1980s and remains the majority intervention in the United States. However, its success rate never reached that of open techniques, Bankart and Latarjet. Surgeons therefore sought the predictors of these failures in order to define the limits of the indications for arthroscopic Bankart intervention.

The determination and use of the preoperative instability score (Instability Severity Index Score : ISIS) described by Balg and Boileau is one of the ways to clarify these indications.

The aim of this study is to prospectively establish the values of the ISIS score to obtain an acceptable recurrence rate of long-term instability

ipd_sharing: Undecided

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de RENNES


title: Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode

acronym: BUPRIS

summary: This study aims at investigating if adjunctive buprenorphine at low dose to treatment as usual is effective in reducing severe suicidal ideas in major depressive episode, and at determining the most effective dose.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Hospices Civils de Lyon
Clinique Les Sophoras
CHRU Hôpital Saint-Jacques
CHU Grenoble Alpes
CH Sainte-Anne
CHU Bicêtre
CHU Lapeyronie
CHU Nîmes
CHU de Tours
CAPPA Jacques PREVERT
CH Henri Laborit