title: Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy: a Multicenter Validation of Clinical Decision Rule

summary: Evaluate the reproducibility and validate a posteriori a new rule of clinical decision on a multi-center population of children with a post-chemotherapy febrile neutropenia

location_facility: Hôpital Jeanne de Flandre - CHRU de Lille


title: A Multicentre, Open Study Assessing Joint Disorders Under ARIMIDEX® (1mg/Day) as Adjuvant Treatment in Post Menopausal Women With Early Breast Cancer

summary: The purpose of this study is to describe the joint symptoms and structural joint changes under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: AstraZeneca

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Multicentre, Randomised, Double-Blind, Non-Comparative Phase II Trial Of ZD1839 (Iressa™) And Placebo In Combination With Chemotherapy With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer

summary: This is a multicentre, randomised (2:1), double blind, non-comparative phase II trial of ZD1839 and placebo in combination with chemotherapy in patients with metastatic breast cancer.

design_allocation: Randomized


type: Registry Identifier

title: PET/CT Guided Antifungal Stewardship in Invasive Pulmonary Aspergillosis

acronym: OPTIFIL

summary:
OPTIFIL is a pilot prospective multicenter study based over the hypothesis that the normalization of the functional imaging 18F-FDG-PET/CT during the Invasive pulmonary aspergillosis (IPA) could occur earlier than that of conventional imaging.

This study evaluates the therapeutic response through a systematic 18F-FDG-PET/CT at week 6. The latter response will be correlated with the kinetics of selected biomarkers including antigens (galactomannan, β-D glucans), circulating Aspergillus DNA and anti-Aspergillus host response markers in addition to the conventional imaging tools obtained at weeks 6 and 12.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

primary_purpose: Other

ReferenceType: background

ReferenceCitation: Lortholary O, Gangneux JP, Sitbon K, Lebeau B, de Monbrison F, Le Strat Y, Coignard B, Dromer F, Bretagne S; French Mycosis Study Group. Epidemiological trends in invasive aspergillosis in France: the SAIF network (2005-2007). Clin Microbiol Infect. 2011 Dec;17(12):1882-9. doi: 10.1111/j.1469-0691.2011.03548.x. Epub 2011 Jun 10.

ReferenceCitation: Bitar D, Lortholary O, Le Strat Y, Nicolau J, Coignard B, Tattevin P, Che D, Dromer F. Population-based analysis of invasive fungal infections, France, 2001-2010. Emerg Infect Dis. 2014 Jul;20(7):1149-55. doi: 10.3201/eid2007.140087.

ReferenceCitation: Herbrecht R, Caillot D, Cordonnier C, Auvrignon A, Thiébaut A, Brethon B, Michallet M, Mahlaoui N, Bertrand Y, Preziosi P, Ruiz F, Gorin NC, Gangneux JP. Indications and outcomes of antifungal therapy in French patients with haematological conditions or recipients of haematopoietic stem cell transplantation. J Antimicrob Chemother. 2012 Nov;67(11):2731-8. doi: 10.1093/jac/dks266. Epub 2012 Jul 31.

ReferenceCitation: Baxter CG, Marshall A, Roberts M, Felton TW, Denning DW. Peripheral neuropathy in patients on long-term triazole antifungal therapy. J Antimicrob Chemother. 2011 Sep;66(9):2136-9. doi: 10.1093/jac/dkr233. Epub 2011 Jun 17.

ReferenceCitation: Epaulard O, Villier C, Ravaud P, Chosidow O, Blanche S, Mamzer-Bruneel MF, Thiébaut A, Leccia MT, Lortholary O. A multistep voriconazole-related phototoxic pathway may lead to skin carcinoma: results from a French nationwide study. Clin Infect Dis. 2013 Dec;57(12):e182-8. doi: 10.1093/cid/cit600. Epub 2013 Sep 17.

ReferenceCitation: Tedja R, El-Sherief A, Olbrych T, Gordon S. Multifocal periostitis as a complication of chronic use of voriconazole in a lung transplant recipient. Transpl Infect Dis. 2013 Aug;15(4):424-9. doi: 10.1111/tid.12088. Epub 2013 May 13. Review.

ReferenceCitation: Moon WJ, Scheller EL, Suneja A, Livermore JA, Malani AN, Moudgal V, Kerr LE, Ferguson E, Vandenberg DM. Plasma fluoride level as a predictor of voriconazole-induced periostitis in patients with skeletal pain. Clin Infect Dis. 2014 Nov 1;59(9):1237-45. doi: 10.1093/cid/ciu513. Epub 2014 Jul 3.

ReferenceCitation: Hot A, Maunoury C, Poiree S, Lanternier F, Viard JP, Loulergue P, Coignard H, Bougnoux ME, Suarez F, Rubio MT, Mahlaoui N, Dupont B, Lecuit M, Faraggi M, Lortholary O. Diagnostic contribution of positron emission tomography with [18F]fluorodeoxyglucose for invasive fungal infections. Clin Microbiol Infect. 2011 Mar;17(3):409-17. doi: 10.1111/j.1469-0691.2010.03301.x.

ReferenceCitation: Chamilos G, Macapinlac HA, Kontoyiannis DP. The use of 18F-fluorodeoxyglucose positron emission tomography for the diagnosis and management of invasive mould infections. Med Mycol. 2008 Feb;46(1):23-9. doi: 10.1080/13693780701639546.

ReferenceCitation: Marr KA, Schlamm HT, Herbrecht R, Rottinghaus ST, Bow EJ, Cornely OA, Heinz WJ, Jagannatha S, Koh LP, Kontoyiannis DP, Lee DG, Nucci M, Pappas PG, Slavin MA, Queiroz-Telles F, Selleslag D, Walsh TJ, Wingard JR, Maertens JA. Combination antifungal therapy for invasive aspergillosis: a randomized trial. Ann Intern Med. 2015 Jan 20;162(2):81-9. doi: 10.7326/M13-2508. Erratum in: Ann Intern Med. 2015 Mar 17;162(6):463. Ann Intern Med. 2019 Feb 5;170(3):220.

name: From Johns Hopkins University School of Medicine and the Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland; Pfizer and Weill Cornell Medical Center, Cornell University, New York, New York; Hôpital de Hautepierre, Strasbourg, France; CancerCare Manitoba and the University of Manitoba, Winnipeg, Manitoba, Canada; First Department of Internal Medicine, Clinical Trials Centre Cologne, ZKS Köln, BMBF 01KN1106, Köln, Germany; University of Würzburg Medical Centre, Würzburg, Germany; National...

family: Marr

full_name: Kieren A. Marr

given: Kieren A.

sequence: first

family: Schlamm

full_name: Haran T. Schlamm

given: Haran T.

sequence: additional

family: Herbrecht

full_name: Raoul Herbrecht

given: Raoul

family: Rottinghaus

full_name: Scott T. Rottinghaus

given: Scott T.

family: Bow

full_name: Eric J. Bow

given: Eric J.

family: Cornely

full_name: Oliver A. Cornely

given: Oliver A.

family: Heinz

full_name: Werner J. Heinz

given: Werner J.

family: Jagannatha

full_name: Shyla Jagannatha

given: Shyla

family: Koh

full_name: Liang Piu Koh

given: Liang Piu

family: Kontoyiannis

full_name: Dimitrios P. Kontoyiannis

given: Dimitrios P.

family: Lee

full_name: Dong-Gun Lee

given: Dong-Gun

family: Nucci

full_name: Marcio Nucci

given: Marcio

family: Pappas

full_name: Peter G. Pappas

given: Peter G.

family: Slavin

full_name: Monica A. Slavin

given: Monica A.

family: Queiroz-Telles

full_name: Flavio Queiroz-Telles

given: Flavio

family: Selleslag

full_name: Dominik Selleslag

given: Dominik

family: Walsh

full_name: Thomas J. Walsh

given: Thomas J.

family: Wingard

full_name: John R. Wingard

given: John R.

family: Maertens

full_name: Johan A. Maertens

given: Johan A.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Internal Medicine

publisher: American College of Physicians

title: Combination Antifungal Therapy for Invasive Aspergillosis

ReferenceCitation: Segal BH, Herbrecht R, Stevens DA, Ostrosky-Zeichner L, Sobel J, Viscoli C, Walsh TJ, Maertens J, Patterson TF, Perfect JR, Dupont B, Wingard JR, Calandra T, Kauffman CA, Graybill JR, Baden LR, Pappas PG, Bennett JE, Kontoyiannis DP, Cordonnier C, Viviani MA, Bille J, Almyroudis NG, Wheat LJ, Graninger W, Bow EJ, Holland SM, Kullberg BJ, Dismukes WE, De Pauw BE. Defining responses to therapy and study outcomes in clinical trials of invasive fungal diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer consensus criteria. Clin Infect Dis. 2008 Sep 1;47(5):674-83. doi: 10.1086/590566. Review.

location_facility: Department of Infectious Diseases and Tropical Medicine, Necker enfants malades hospital


type: EudraCT Number

title: Phase 1-2 Study of Safety and Efficacy of Intrathecal Trastuzumab Administration in Metastatic HER2 Positive Breast Cancer Patients Developing Carcinomatous Meningitis

acronym: HIT

summary:
The purpose of this study is:

Phase I: To determine the Trastuzumab maximum tolerated dose (MTD) when weekly administrated by intrathecal or intraventricular route to reach a intra CSF target concentration (30 µg/mL) near the conventional therapeutic concentration and depending on the dose-limiting toxicity (DLT)

Phase II: Determination of antitumor activity trastuzumab when administrated by IT or intra-ventricular in terms of neurological progression-free survival at 2 months

ReferenceType: derived

ReferenceCitation: Bonneau C, Paintaud G, Trédan O, Dubot C, Desvignes C, Dieras V, Taillibert S, Tresca P, Turbiez I, Li J, Passot C, Mefti F, Mouret-Fourme E, Le Rhun E, Gutierrez M. Phase I feasibility study for intrathecal administration of trastuzumab in patients with HER2 positive breast carcinomatous meningitis. Eur J Cancer. 2018 May;95:75-84. doi: 10.1016/j.ejca.2018.02.032. Epub 2018 Apr 7.

family: Bonneau

full_name: Claire Bonneau

given: Claire

family: Paintaud

full_name: Gilles Paintaud

given: Gilles

family: Trédan

full_name: Olivier Trédan

given: Olivier

family: Dubot

full_name: Coraline Dubot

given: Coraline

family: Desvignes

full_name: Céline Desvignes

given: Céline

family: Dieras

full_name: Véronique Dieras

given: Véronique

family: Taillibert

full_name: Sophie Taillibert

given: Sophie

family: Tresca

full_name: Patricia Tresca

given: Patricia

family: Turbiez

full_name: Isabelle Turbiez

given: Isabelle

family: Li

full_name: Jacques Li

given: Jacques

family: Passot

full_name: Christophe Passot

given: Christophe

family: Mefti

full_name: Fawzia Mefti

given: Fawzia

family: Mouret-Fourme

full_name: Emmanuelle Mouret-Fourme

given: Emmanuelle

family: Le Rhun

full_name: Emilie Le Rhun

given: Emilie

family: Gutierrez

full_name: Maya Gutierrez

given: Maya

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Institut Curie

location_facility: Institut Univesitaire du Cancer de Toulouse

location_facility: Institut Curie - Claudius Regaud Hospital

lead_sponsor_type: academique


title: Prostacyclin (PGI2) Pathway to Enhance Wound Healing in Diabetic Foot Ulcers

summary: Prospective, monocentric, pathophysiological study, comparing 3 parallel groups: healthy controls; patients with diabetes and without DFU; patients with diabetes and with DFU. To address secondary objectives, samples from a fourth group will be collected.

status: Recruiting

primary_purpose: Basic Science

enrollment_type: Anticipated

ReferenceCitation: Knebel SM, Sprague RS, Stephenson AH. Prostacyclin receptor expression on platelets of humans with type 2 diabetes is inversely correlated with hemoglobin A1c levels. Prostaglandins Other Lipid Mediat. 2015 Jan-Mar;116-117:131-5. doi: 10.1016/j.prostaglandins.2014.12.002. Epub 2015 Jan 21.

ReferenceCitation: Gohin S, Sigaudo-Roussel D, Conjard-Duplany A, Dubourg L, Saumet JL, Fromy B. What can current stimulation tell us about the vascular function of endogenous prostacyclin in healthy rat skin in vivo? J Invest Dermatol. 2011 Jan;131(1):237-44. doi: 10.1038/jid.2010.267. Epub 2010 Sep 9.

ReferenceCitation: Gibbons CH, Freeman R, Veves A. Diabetic neuropathy: a cross-sectional study of the relationships among tests of neurophysiology. Diabetes Care. 2010 Dec;33(12):2629-34. doi: 10.2337/dc10-0763. Epub 2010 Aug 30.

ReferenceCitation: Hellmann M, Roustit M, Gaillard-Bigot F, Cracowski JL. Cutaneous iontophoresis of treprostinil, a prostacyclin analog, increases microvascular blood flux in diabetic malleolus area. Eur J Pharmacol. 2015 Jul 5;758:123-8. doi: 10.1016/j.ejphar.2015.03.066. Epub 2015 Apr 3.

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data sending an e-mail to : jlcracowski@chu-grenoble.fr or mroustit@chu-grenoble.fr

lead_sponsor: University Hospital, Grenoble

location_facility: CHU Grenoble Alpes Centre d'investigation clinique

intervention_type: Diagnostic Test

status_simplified: Ongoing


type: Other Identifier

title: Characterization of the microVAScular Dysfunction in COvid-19 ARDS

acronym: VASCOV

summary:
The primary endpoint of this research is to establish that the alveolar dead space is significantly higher in patients with COVID-19 ARDS, compared to patients with non-COVID-19 ARDS.

Secondarily, the investigators want to establish the prognostic value of the alveolar-dead space (measured iteratively) in patients with COVID-19 and non-COVID-19 ARDS, to establish the respective influences of the biological parameters of endothelial damage, of the biological parameters of coagulopathy, of the parameters set on the artificial ventilator on the value of the alveolar dead space; in ARDS patients with COVID-19 and non-COVID-19 ARDS, to establish the prognostic value of the laboratory parameters of endothelial damage and coagulopathy in patients with COVID-19 and non-COVID-19 ARDS.

study_start_date_type: Anticipated

status: Not yet recruiting

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Diehl JL, Peron N, Chocron R, Debuc B, Guerot E, Hauw-Berlemont C, Hermann B, Augy JL, Younan R, Novara A, Langlais J, Khider L, Gendron N, Goudot G, Fagon JF, Mirault T, Smadja DM. Respiratory mechanics and gas exchanges in the early course of COVID-19 ARDS: a hypothesis-generating study. Ann Intensive Care. 2020 Jul 16;10(1):95. doi: 10.1186/s13613-020-00716-1.

ReferenceCitation: Ackermann M, Verleden SE, Kuehnel M, Haverich A, Welte T, Laenger F, Vanstapel A, Werlein C, Stark H, Tzankov A, Li WW, Li VW, Mentzer SJ, Jonigk D. Pulmonary Vascular Endothelialitis, Thrombosis, and Angiogenesis in Covid-19. N Engl J Med. 2020 Jul 9;383(2):120-128. doi: 10.1056/NEJMoa2015432. Epub 2020 May 21.

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: SDB Prevalence and Cardiovascular Outcomes of MI Survivors

acronym: AMISLEEP

summary:
The AMISLEEP study is nested in the "FRENCHIE" registry.

The objective is to use routine clinical and polygraphic data to capture SDB/SAS (Sleep Disordered Breathing/Sleep Apnea Syndrome) physiological heterogeneity in relation to clinically relevant cardiovascular outcomes.

Specifically, the investigators hypothesize that unique clusters (phenotypes) of patients could be identified by applying unsupervised learning methods to these data and that the clusters would be differentially associated with risk of adverse cardiovascular outcomes (ACS), TIA, stroke or death). The ultimate goal is to identify patients more at risk that could be included in interventional studies that would test whether SDB/SAS treatment can improve this risk.

primary_purpose: Diagnostic

ReferenceCitation: Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5.

ReferenceCitation: Durán J, Esnaola S, Rubio R, Iztueta A. Obstructive sleep apnea-hypopnea and related clinical features in a population-based sample of subjects aged 30 to 70 yr. Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):685-9.

ReferenceCitation: Crawford-Achour E, Dauphinot V, Martin MS, Tardy M, Gonthier R, Barthelemy JC, Roche F. Protective Effect of Long-Term CPAP Therapy on Cognitive Performance in Elderly Patients with Severe OSA: The PROOF Study. J Clin Sleep Med. 2015 Apr 15;11(5):519-24. doi: 10.5664/jcsm.4694.

ReferenceCitation: Cadelis G, Fayad Y Monteagudo OE. [Prevalence of symptoms and risk of obstructive sleep apnea syndrome assessed by the Berlin Questionnaire among professionals of a health facility]. Rev Epidemiol Sante Publique. 2016 Dec;64(6):405-414. doi: 10.1016/j.respe.2016.06.332. Epub 2016 Oct 31. French.

ReferenceCitation: Tishler PV, Larkin EK, Schluchter MD, Redline S. Incidence of sleep-disordered breathing in an urban adult population: the relative importance of risk factors in the development of sleep-disordered breathing. JAMA. 2003 May 7;289(17):2230-7.

ReferenceCitation: Heinzer R, Vat S, Marques-Vidal P, Marti-Soler H, Andries D, Tobback N, Mooser V, Preisig M, Malhotra A, Waeber G, Vollenweider P, Tafti M, Haba-Rubio J. Prevalence of sleep-disordered breathing in the general population: the HypnoLaus study. Lancet Respir Med. 2015 Apr;3(4):310-8. doi: 10.1016/S2213-2600(15)00043-0. Epub 2015 Feb 12.

ReferenceCitation: Levendowski D, Steward D, Woodson BT, Olmstead R, Popovic D, Westbrook P. The impact of obstructive sleep apnea variability measured in-lab versus in-home on sample size calculations. Int Arch Med. 2009 Jan 2;2(1):2. doi: 10.1186/1755-7682-2-2.

ReferenceCitation: Jesus EV, Dias-Filho EB, Mota Bde M, Souza Ld, Marques-Santos C, Rocha JB, Oliveira JL, Sousa AC, Barreto-Filho JA. Suspicion of obstructive sleep apnea by Berlin Questionnaire predicts events in patients with acute coronary syndrome. Arq Bras Cardiol. 2010 Sep;95(3):313-20. Epub 2010 Aug 6.

ReferenceCitation: Gus M, Gonçalves SC, Martinez D, de Abreu Silva EO, Moreira LB, Fuchs SC, Fuchs FD. Risk for Obstructive Sleep Apnea by Berlin Questionnaire, but not daytime sleepiness, is associated with resistant hypertension: a case-control study. Am J Hypertens. 2008 Jul;21(7):832-5. doi: 10.1038/ajh.2008.184. Epub 2008 May 1.

ipd_sharing: Undecided


title: French Cohort of Myocardial Infarction Evaluation

acronym: FRENCHIE

summary:
Over the last two decades, considerable progress has been made in the management of Acute Myocardial Infarction (AMI), both in the acute phase and in monitoring beyond the hospital phase. Nevertheless, the evolution of care practices and their impact on the mid- and long-term prognosis of patients admitted to the intensive care unit for acute myocardial infarction remain relatively little studied exhaustively.

The aim of this study is to assess the profile of AMI patients, their management and follow-up in order to evaluate the relationship between these factors and outcomes.

ReferenceCitation: Hasdai D, Behar S, Wallentin L, Danchin N, Gitt AK, Boersma E, Fioretti PM, Simoons ML, Battler A. A prospective survey of the characteristics, treatments and outcomes of patients with acute coronary syndromes in Europe and the Mediterranean basin; the Euro Heart Survey of Acute Coronary Syndromes (Euro Heart Survey ACS). Eur Heart J. 2002 Aug;23(15):1190-201.

ReferenceCitation: Pedersen TR, Kjekshus J, Berg K, Haghfelt T, Faergeman O, Faergeman G, Pyörälä K, Miettinen T, Wilhelmsen L, Olsson AG, Wedel H; Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). 1994. Atheroscler Suppl. 2004 Oct;5(3):81-7.

ReferenceCitation: Sacks FM, Pfeffer MA, Moye LA, Rouleau JL, Rutherford JD, Cole TG, Brown L, Warnica JW, Arnold JM, Wun CC, Davis BR, Braunwald E. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators. N Engl J Med. 1996 Oct 3;335(14):1001-9.

ReferenceCitation: Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002 Jul 6;360(9326):7-22.

ReferenceCitation: GUSTO investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med. 1993 Sep 2;329(10):673-82.

ReferenceCitation: Andersen HR, Nielsen TT, Rasmussen K, Thuesen L, Kelbaek H, Thayssen P, Abildgaard U, Pedersen F, Madsen JK, Grande P, Villadsen AB, Krusell LR, Haghfelt T, Lomholt P, Husted SE, Vigholt E, Kjaergard HK, Mortensen LS; DANAMI-2 Investigators. A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction. N Engl J Med. 2003 Aug 21;349(8):733-42.

ReferenceCitation: Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. Review.

ReferenceCitation: Danchin N, Vaur L, Genès N, Etienne S, Angioï M, Ferrières J, Cambou JP. Treatment of acute myocardial infarction by primary coronary angioplasty or intravenous thrombolysis in the "real world": one-year results from a nationwide French survey. Circulation. 1999 May 25;99(20):2639-44.

ReferenceCitation: Danchin N, Vaur L, Genès N, Renault M, Ferrières J, Etienne S, Cambou JP. Management of acute myocardial infarction in intensive care units in 1995: a nationwide French survey of practice and early hospital results. J Am Coll Cardiol. 1997 Dec;30(7):1598-605.

ReferenceCitation: Hanania G, Cambou JP, Guéret P, Vaur L, Blanchard D, Lablanche JM, Boutalbi Y, Humbert R, Clerson P, Genès N, Danchin N; USIC 2000 Investigators. Management and in-hospital outcome of patients with acute myocardial infarction admitted to intensive care units at the turn of the century: results from the French nationwide USIC 2000 registry. Heart. 2004 Dec;90(12):1404-10.

ReferenceCitation: Danchin N, Blanchard D, Steg PG, Sauval P, Hanania G, Goldstein P, Cambou JP, Guéret P, Vaur L, Boutalbi Y, Genès N, Lablanche JM; USIC 2000 Investigators. Impact of prehospital thrombolysis for acute myocardial infarction on 1-year outcome: results from the French Nationwide USIC 2000 Registry. Circulation. 2004 Oct 5;110(14):1909-15. Epub 2004 Sep 27.

ReferenceCitation: Ferrières J, Cambou JP, Guéret P, Boutalbi Y, Lablanche JM, Hanania G, Genès N, Cantet C, Danchin N. Effect of early initiation of statins on survival in patients with acute myocardial infarction (the USIC 2000 Registry). Am J Cardiol. 2005 Feb 15;95(4):486-9.

ReferenceCitation: Heidenreich PA, Alloggiamento T, Melsop K, McDonald KM, Go AS, Hlatky MA. The prognostic value of troponin in patients with non-ST elevation acute coronary syndromes: a meta-analysis. J Am Coll Cardiol. 2001 Aug;38(2):478-85.

ReferenceCitation: Cambou JP, Simon T, Mulak G, Bataille V, Danchin N. The French registry of Acute ST elevation or non-ST-elevation Myocardial Infarction (FAST-MI): study design and baseline characteristics. Arch Mal Coeur Vaiss. 2007 Jun-Jul;100(6-7):524-34.

ReferenceCitation: Hanssen M, Cottin Y, Khalife K, Hammer L, Goldstein P, Puymirat E, Mulak G, Drouet E, Pace B, Schultz E, Bataille V, Ferrières J, Simon T, Danchin N; FAST-MI 2010 Investigators. French Registry on Acute ST-elevation and non ST-elevation Myocardial Infarction 2010. FAST-MI 2010. Heart. 2012 May;98(9):699-705. doi: 10.1136/heartjnl-2012-301700.

family: Hanssen

full_name: Michel Hanssen

given: Michel

family: Cottin

full_name: Yves Cottin

given: Yves

family: Khalife

full_name: Khalife Khalife

given: Khalife

family: Hammer

full_name: Laure Hammer

given: Laure

family: Goldstein

full_name: Patrick Goldstein

given: Patrick

family: Puymirat

full_name: Etienne Puymirat

given: Etienne

family: Mulak

full_name: Geneviève Mulak

given: Geneviève

family: Drouet

full_name: Elodie Drouet

given: Elodie

family: Pace

full_name: Benoit Pace

given: Benoit

family: Schultz

full_name: Eric Schultz

given: Eric

family: Bataille

full_name: Vincent Bataille

given: Vincent

family: Ferrières

full_name: Jean Ferrières

given: Jean

family: Simon

full_name: Tabassome Simon

given: Tabassome

family: Danchin

full_name: Nicolas Danchin

given: Nicolas

journal_name: Heart

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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)

ReferenceCitation: Danchin N, Coste P, Ferrières J, Steg PG, Cottin Y, Blanchard D, Belle L, Ritz B, Kirkorian G, Angioi M, Sans P, Charbonnier B, Eltchaninoff H, Guéret P, Khalife K, Asseman P, Puel J, Goldstein P, Cambou JP, Simon T; FAST-MI Investigators. Comparison of thrombolysis followed by broad use of percutaneous coronary intervention with primary percutaneous coronary intervention for ST-segment-elevation acute myocardial infarction: data from the french registry on acute ST-elevation myocardial infarction (FAST-MI). Circulation. 2008 Jul 15;118(3):268-76. doi: 10.1161/CIRCULATIONAHA.107.762765. Epub 2008 Jun 30.

ReferenceCitation: Danchin N, Puymirat E, Steg PG, Goldstein P, Schiele F, Belle L, Cottin Y, Fajadet J, Khalife K, Coste P, Ferrières J, Simon T; FAST-MI 2005 Investigators. Five-year survival in patients with ST-segment-elevation myocardial infarction according to modalities of reperfusion therapy: the French Registry on Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) 2005 Cohort. Circulation. 2014 Apr 22;129(16):1629-36. doi: 10.1161/CIRCULATIONAHA.113.005874. Epub 2014 Mar 21.

name: From the Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Paris, France (N.D., E.P.); INSERM U 970, Paris, France (N.D., E.P.); Université Paris Descartes, Paris, France (N.D., E.P.); Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris, France (P.G.S.); INSERM U 698, Paris, France (P.G.S.); Université Paris Diderot, Paris, France (P.G.S.); Centre Hospitalier Régional Universitaire de Lille, Lille, France (P.G.); Hôpital Jean Minjoz, Besançon, France (F.S.);...

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Five-Year Survival in Patients With ST-Segment–Elevation Myocardial Infarction According to Modalities of Reperfusion Therapy

ReferenceCitation: Ferrières J, Bataille V, Leclercq F, Geslin P, Ruidavets JB, Grollier G, Bernard P, Cambou JP, Simon T, Danchin N. Patterns of statin prescription in acute myocardial infarction: the French registry of Acute ST-elevation or non-ST-elevation Myocardial Infarction (FAST-MI). Atherosclerosis. 2009 Jun;204(2):491-6. doi: 10.1016/j.atherosclerosis.2008.09.031. Epub 2008 Oct 8.

ReferenceCitation: Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Méneveau N, Steg PG, Ferrières J, Danchin N, Becquemont L; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) Investigators. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med. 2009 Jan 22;360(4):363-75. doi: 10.1056/NEJMoa0808227. Epub 2008 Dec 22.

title: Genetic Determinants of Response to Clopidogrel and Cardiovascular Events

ReferenceCitation: Puymirat E, Simon T, Steg PG, Schiele F, Guéret P, Blanchard D, Khalife K, Goldstein P, Cattan S, Vaur L, Cambou JP, Ferrières J, Danchin N; USIK USIC 2000 Investigators; FAST MI Investigators. Association of changes in clinical characteristics and management with improvement in survival among patients with ST-elevation myocardial infarction. JAMA. 2012 Sep 12;308(10):998-1006. doi: 10.1001/2012.jama.11348.

ReferenceCitation: Puymirat E, Schiele F, Steg PG, Blanchard D, Isorni MA, Silvain J, Goldstein P, Guéret P, Mulak G, Berard L, Bataille V, Cattan S, Ferrières J, Simon T, Danchin N; FAST-MI investigators. Determinants of improved one-year survival in non-ST-segment elevation myocardial infarction patients: insights from the French FAST-MI program over 15 years. Int J Cardiol. 2014 Nov 15;177(1):281-6. doi: 10.1016/j.ijcard.2014.09.023. Epub 2014 Sep 28.

title: Determinants of improved one-year survival in non-ST-segment elevation myocardial infarction patients: Insights from the French FAST-MI program over 15years

ReferenceCitation: Puymirat E, Taldir G, Aissaoui N, Lemesle G, Lorgis L, Cuisset T, Bourlard P, Maillier B, Ducrocq G, Ferrieres J, Simon T, Danchin N. Use of invasive strategy in non-ST-segment elevation myocardial infarction is a major determinant of improved long-term survival: FAST-MI (French Registry of Acute Coronary Syndrome). JACC Cardiovasc Interv. 2012 Sep;5(9):893-902. doi: 10.1016/j.jcin.2012.05.008.

title: Use of Invasive Strategy in Non–ST-Segment Elevation Myocardial Infarction Is a Major Determinant of Improved Long-Term Survival

ReferenceCitation: Franklin K, Goldberg RJ, Spencer F, Klein W, Budaj A, Brieger D, Marre M, Steg PG, Gowda N, Gore JM; GRACE Investigators. Implications of diabetes in patients with acute coronary syndromes. The Global Registry of Acute Coronary Events. Arch Intern Med. 2004 Jul 12;164(13):1457-63.

ReferenceCitation: Steg PG, Iung B, Feldman LJ, Cokkinos D, Deckers J, Fox KA, Keil U, Maggioni AP. Impact of availability and use of coronary interventions on the prescription of aspirin and lipid lowering treatment after acute coronary syndromes. Heart. 2002 Jul;88(1):20-4.

ReferenceCitation: Amar J, Chamontin B, Ferriéres J, Danchin N, Grenier O, Cantet C, Cambou JP. Hypertension control at hospital discharge after acute coronary event: influence on cardiovascular prognosis--the PREVENIR study. Heart. 2002 Dec;88(6):587-91.

ReferenceCitation: Danchin N, Grenier O, Ferrières J, Cantet C, Cambou JP. Use of secondary preventive drugs in patients with acute coronary syndromes treated medically or with coronary angioplasty: results from the nationwide French PREVENIR survey. Heart. 2002 Aug;88(2):159-62.

ReferenceCitation: Zeller M, Cottin Y, Brindisi MC, Dentan G, Laurent Y, Janin-Manificat L, L'Huillier I, Beer JC, Touzery C, Makki H, Verges B, Wolf JE; RICO survey working group. Impaired fasting glucose and cardiogenic shock in patients with acute myocardial infarction. Eur Heart J. 2004 Feb;25(4):308-12.

ReferenceCitation: Chambless L, Keil U, Dobson A, Mähönen M, Kuulasmaa K, Rajakangas AM, Löwel H, Tunstall-Pedoe H. Population versus clinical view of case fatality from acute coronary heart disease: results from the WHO MONICA Project 1985-1990. Multinational MONItoring of Trends and Determinants in CArdiovascular Disease. Circulation. 1997 Dec 2;96(11):3849-59.

ReferenceCitation: Marques-Vidal P, Ferrières J, Metzger MH, Cambou JP, Filipiak B, Löwel H, Keil U. Trends in coronary heart disease morbidity and mortality and acute coronary care and case fatality from 1985-1989 in southern Germany and south-western France. Eur Heart J. 1997 May;18(5):816-21.

ReferenceCitation: Mesnier J, Cottin Y, Coste P, Ferrari E, Schiele F, Lemesle G, Thuaire C, Angoulvant D, Cayla G, Bouleti C, Gallet de Saint Aurin R, Goube P, Lhermusier T, Dillinger JG, Paganelli F, Saib A, Prunier F, Vanzetto G, Dubreuil O, Puymirat E, Boccara F, Eltchaninoff H, Cachanado M, Rousseau A, Drouet E, Steg PG, Simon T, Danchin N. Hospital admissions for acute myocardial infarction before and after lockdown according to regional prevalence of COVID-19 and patient profile in France: a registry study. Lancet Public Health. 2020 Oct;5(10):e536-e542. doi: 10.1016/S2468-2667(20)30188-2. Epub 2020 Sep 18.

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

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

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

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central


title: Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)

acronym: PAROCARD

summary:
Multicenter randomized clinical trial with two arms in patients hospitalized for an AMI nested in the Frenchie registry. Periodontal therapy is performed by periodontists in the intervention group versus treatment by dental surgeons as part of their usual practice in the control group.

For the intervention group, periodontal management will be carried out for a maximum of 6 months after randomisation, prolonged by a follow-up of 6 months including a maintenance visit at M9.

All patients will have an FDG-PET at M0 and M12 for evaluation of inflammation on carotid atherosclerotic plaques.

ReferenceCitation: Lockhart PB, Bolger AF, Papapanou PN, Osinbowale O, Trevisan M, Levison ME, Taubert KA, Newburger JW, Gornik HL, Gewitz MH, Wilson WR, Smith SC Jr, Baddour LM; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee of the Council on Cardiovascular Disease in the Young, Council on Epidemiology and Prevention, Council on Peripheral Vascular Disease, and Council on Clinical Cardiology. Periodontal disease and atherosclerotic vascular disease: does the evidence support an independent association?: a scientific statement from the American Heart Association. Circulation. 2012 May 22;125(20):2520-44. doi: 10.1161/CIR.0b013e31825719f3. Epub 2012 Apr 18.

ReferenceCitation: Tonetti MS, Van Dyke TE; working group 1 of the joint EFP/AAP workshop. Periodontitis and atherosclerotic cardiovascular disease: consensus report of the Joint EFP/AAP Workshop on Periodontitis and Systemic Diseases. J Periodontol. 2013 Apr;84(4 Suppl):S24-9. doi: 10.1902/jop.2013.1340019.

ReferenceCitation: LaMonte MJ, Genco RJ, Hovey KM, Wallace RB, Freudenheim JL, Michaud DS, Mai X, Tinker LF, Salazar CR, Andrews CA, Li W, Eaton CB, Martin LW, Wactawski-Wende J. History of Periodontitis Diagnosis and Edentulism as Predictors of Cardiovascular Disease, Stroke, and Mortality in Postmenopausal Women. J Am Heart Assoc. 2017 Mar 29;6(4). pii: e004518. doi: 10.1161/JAHA.116.004518.

ReferenceCitation: Adolph M, Darnaud C, Thomas F, Pannier B, Danchin N, Batty GD, Bouchard P. Oral health in relation to all-cause mortality: the IPC cohort study. Sci Rep. 2017 Mar 15;7:44604. doi: 10.1038/srep44604.

ReferenceCitation: Schmitt A, Carra MC, Boutouyrie P, Bouchard P. Periodontitis and arterial stiffness: a systematic review and meta-analysis. J Clin Periodontol. 2015 Nov;42(11):977-87. doi: 10.1111/jcpe.12467. Epub 2015 Nov 24. Review.

ReferenceCitation: Piconi S, Trabattoni D, Luraghi C, Perilli E, Borelli M, Pacei M, Rizzardini G, Lattuada A, Bray DH, Catalano M, Sparaco A, Clerici M. Treatment of periodontal disease results in improvements in endothelial dysfunction and reduction of the carotid intima-media thickness. FASEB J. 2009 Apr;23(4):1196-204. doi: 10.1096/fj.08-119578. Epub 2008 Dec 12.

ReferenceCitation: Tonetti MS, D'Aiuto F, Nibali L, Donald A, Storry C, Parkar M, Suvan J, Hingorani AD, Vallance P, Deanfield J. Treatment of periodontitis and endothelial function. N Engl J Med. 2007 Mar 1;356(9):911-20. Erratum in: N Engl J Med. 2018 Jun 13;:null.

ReferenceCitation: Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785. Review.

ReferenceCitation: Eke PI, Dye BA, Wei L, Slade GD, Thornton-Evans GO, Borgnakke WS, Taylor GW, Page RC, Beck JD, Genco RJ. Update on Prevalence of Periodontitis in Adults in the United States: NHANES 2009 to 2012. J Periodontol. 2015 May;86(5):611-22. doi: 10.1902/jop.2015.140520. Epub 2015 Feb 17.

ReferenceCitation: Kassebaum NJ, Bernabé E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26. Review.

ReferenceCitation: Bahekar AA, Singh S, Saha S, Molnar J, Arora R. The prevalence and incidence of coronary heart disease is significantly increased in periodontitis: a meta-analysis. Am Heart J. 2007 Nov;154(5):830-7. Epub 2007 Aug 20. Review.

ReferenceCitation: Pussinen PJ, Alfthan G, Jousilahti P, Paju S, Tuomilehto J. Systemic exposure to Porphyromonas gingivalis predicts incident stroke. Atherosclerosis. 2007 Jul;193(1):222-8. Epub 2006 Jul 26.

ReferenceCitation: Reyes L, Herrera D, Kozarov E, Roldán S, Progulske-Fox A. Periodontal bacterial invasion and infection: contribution to atherosclerotic pathology. J Clin Periodontol. 2013 Apr;40 Suppl 14:S30-50. doi: 10.1111/jcpe.12079. Review.

ReferenceCitation: Pessi T, Karhunen V, Karjalainen PP, Ylitalo A, Airaksinen JK, Niemi M, Pietila M, Lounatmaa K, Haapaniemi T, Lehtimäki T, Laaksonen R, Karhunen PJ, Mikkelsson J. Bacterial signatures in thrombus aspirates of patients with myocardial infarction. Circulation. 2013 Mar 19;127(11):1219-28, e1-6. doi: 10.1161/CIRCULATIONAHA.112.001254. Epub 2013 Feb 15.

ReferenceCitation: Offenbacher S, Beck JD, Moss K, Mendoza L, Paquette DW, Barrow DA, Couper DJ, Stewart DD, Falkner KL, Graham SP, Grossi S, Gunsolley JC, Madden T, Maupome G, Trevisan M, Van Dyke TE, Genco RJ. Results from the Periodontitis and Vascular Events (PAVE) Study: a pilot multicentered, randomized, controlled trial to study effects of periodontal therapy in a secondary prevention model of cardiovascular disease. J Periodontol. 2009 Feb;80(2):190-201. doi: 10.1902/jop.2009.080007 .

ReferenceCitation: Teague HL, Ahlman MA, Alavi A, Wagner DD, Lichtman AH, Nahrendorf M, Swirski FK, Nestle F, Gelfand JM, Kaplan MJ, Grinspoon S, Ridker PM, Newby DE, Tawakol A, Fayad ZA, Mehta NN. Unraveling Vascular Inflammation: From Immunology to Imaging. J Am Coll Cardiol. 2017 Sep 12;70(11):1403-1412. doi: 10.1016/j.jacc.2017.07.750. Review.

ReferenceCitation: Subramanian S, Emami H, Vucic E, Singh P, Vijayakumar J, Fifer KM, Alon A, Shankar SS, Farkouh M, Rudd JHF, Fayad ZA, Van Dyke TE, Tawakol A. High-dose atorvastatin reduces periodontal inflammation: a novel pleiotropic effect of statins. J Am Coll Cardiol. 2013 Dec 24;62(25):2382-2391. doi: 10.1016/j.jacc.2013.08.1627. Epub 2013 Sep 24.

ReferenceCitation: Salminen A, Gursoy UK, Paju S, Hyvärinen K, Mäntylä P, Buhlin K, Könönen E, Nieminen MS, Sorsa T, Sinisalo J, Pussinen PJ. Salivary biomarkers of bacterial burden, inflammatory response, and tissue destruction in periodontitis. J Clin Periodontol. 2014 May;41(5):442-50. doi: 10.1111/jcpe.12234. Epub 2014 Feb 17.

ReferenceCitation: Meuric V, Le Gall-David S, Boyer E, Acuña-Amador L, Martin B, Fong SB, Barloy-Hubler F, Bonnaure-Mallet M. Signature of Microbial Dysbiosis in Periodontitis. Appl Environ Microbiol. 2017 Jun 30;83(14). pii: e00462-17. doi: 10.1128/AEM.00462-17. Print 2017 Jul 15.

ReferenceCitation: Bucerius J, Hyafil F, Verberne HJ, Slart RH, Lindner O, Sciagra R, Agostini D, Übleis C, Gimelli A, Hacker M; Cardiovascular Committee of the European Association of Nuclear Medicine (EANM). Position paper of the Cardiovascular Committee of the European Association of Nuclear Medicine (EANM) on PET imaging of atherosclerosis. Eur J Nucl Med Mol Imaging. 2016 Apr;43(4):780-92. doi: 10.1007/s00259-015-3259-3. Epub 2015 Dec 17.

ReferenceCitation: Rudd JH, Myers KS, Bansilal S, Machac J, Rafique A, Farkouh M, Fuster V, Fayad ZA. (18)Fluorodeoxyglucose positron emission tomography imaging of atherosclerotic plaque inflammation is highly reproducible: implications for atherosclerosis therapy trials. J Am Coll Cardiol. 2007 Aug 28;50(9):892-6. Epub 2007 Aug 13.

ReferenceCitation: Boellaard R, Delgado-Bolton R, Oyen WJ, Giammarile F, Tatsch K, Eschner W, Verzijlbergen FJ, Barrington SF, Pike LC, Weber WA, Stroobants S, Delbeke D, Donohoe KJ, Holbrook S, Graham MM, Testanera G, Hoekstra OS, Zijlstra J, Visser E, Hoekstra CJ, Pruim J, Willemsen A, Arends B, Kotzerke J, Bockisch A, Beyer T, Chiti A, Krause BJ; European Association of Nuclear Medicine (EANM). FDG PET/CT: EANM procedure guidelines for tumour imaging: version 2.0. Eur J Nucl Med Mol Imaging. 2015 Feb;42(2):328-54. doi: 10.1007/s00259-014-2961-x. Epub 2014 Dec 2.

ReferenceCitation: Bucerius J, Mani V, Moncrieff C, Rudd JH, Machac J, Fuster V, Farkouh ME, Fayad ZA. Impact of noninsulin-dependent type 2 diabetes on carotid wall 18F-fluorodeoxyglucose positron emission tomography uptake. J Am Coll Cardiol. 2012 Jun 5;59(23):2080-8. doi: 10.1016/j.jacc.2011.11.069.

intervention_type: Other


title: Soluble CD95 Ligand Role in the Pathophysiology of ANCA Associated Vasculitis

acronym: VASC-FAS

summary: The study aims at defining the role of soluble CD95 Ligand in the physiopathology of a rare group of inflammatory diseases: ANCA associated vasculitis. Soluble CD95 Ligand might have a prognostic and diagnostic interest as well as potential for the discovery of new therapeutic strategies.

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - Service d'Immunologie et Immunogénétique

intervention_type: Biological


title: Identification of New Biomarkers of Banana and Tomato Intake

acronym: BioBanaTom

summary: The intake of fruits and vegetables has been associated to a lower risk of developing metabolic diseases and cancer. The intake of tomato has been proposed to decrease the risk of prostate cancer while the high content of pro-vitamine A carotenes in banana have shown to alleviate Vitamin A deficiency in different countries. Interestingly in spite of their popularity, there are no biomarkers of banana intake reported in the literature while lycopene is the most frequently used metabolite to indicate tomato consumption however, its limited specificity and between-subjects variation sets doubt of its accuracy. Therefore, the identification of novel biomarkers for both banana and tomato is of great value. Untargeted metabolomics, allows a holistic analysis of the food metabolome allowing a deeper inquiry in the metabolism of different compounds and the recognition of patterns and individual differences that may lead to new hypothesis and further research. Therefore, the aim of the present study is to identify biomarkers of acute intake of banana and tomato using an untargeted approach on urine serum of 12 volunteers that participated in a crossover, randomized, controlled study. Volunteers consumed three different test foods: 1) 240g of banana, 2) 300g of tomato and 3) Fresubin 2kcal as control. Serum and urine samples were collected in kinetics over 24h and processed to be analyzed using LC-QTof analysis. The metabolomics profiles are compared using univariate (ANOVA) and multivariate statistical methods (PCA, PLSDA). The identification of discriminant compounds was performed by tandem mass fragmentation with a high-resolution LTQ-Orbitrab Mass spectrometer and by an extensive inquiry of different online databases.

ReferenceCitation: Andersen MB, Kristensen M, Manach C, Pujos-Guillot E, Poulsen SK, Larsen TM, Astrup A, Dragsted L. Discovery and validation of urinary exposure markers for different plant foods by untargeted metabolomics. Anal Bioanal Chem. 2014 Mar;406(7):1829-44. doi: 10.1007/s00216-013-7498-5. Epub 2014 Jan 4.

ReferenceCitation: Manach C, Hubert J, Llorach R, Scalbert A. The complex links between dietary phytochemicals and human health deciphered by metabolomics. Mol Nutr Food Res. 2009 Oct;53(10):1303-15. doi: 10.1002/mnfr.200800516. Review.

ReferenceCitation: Scalbert A, Brennan L, Manach C, Andres-Lacueva C, Dragsted LO, Draper J, Rappaport SM, van der Hooft JJ, Wishart DS. The food metabolome: a window over dietary exposure. Am J Clin Nutr. 2014 Jun;99(6):1286-308. doi: 10.3945/ajcn.113.076133. Epub 2014 Apr 23. Review.

ReferenceCitation: Re R, Bramley PM, Rice-Evans C. Effects of food processing on flavonoids and lycopene status in a Mediterranean tomato variety. Free Radic Res. 2002 Jul;36(7):803-10.

ReferenceCitation: Giovannucci E. Tomatoes, tomato-based products, lycopene, and cancer: review of the epidemiologic literature. J Natl Cancer Inst. 1999 Feb 17;91(4):317-31. Review.

ReferenceCitation: Pereira A, Maraschin M. Banana (Musa spp) from peel to pulp: ethnopharmacology, source of bioactive compounds and its relevance for human health. J Ethnopharmacol. 2015 Feb 3;160:149-63. doi: 10.1016/j.jep.2014.11.008. Epub 2014 Nov 13. Review.

ReferenceCitation: Pujos-Guillot E, Hubert J, Martin JF, Lyan B, Quintana M, Claude S, Chabanas B, Rothwell JA, Bennetau-Pelissero C, Scalbert A, Comte B, Hercberg S, Morand C, Galan P, Manach C. Mass spectrometry-based metabolomics for the discovery of biomarkers of fruit and vegetable intake: citrus fruit as a case study. J Proteome Res. 2013 Apr 5;12(4):1645-59. doi: 10.1021/pr300997c. Epub 2013 Mar 5.

ReferenceCitation: Peralta I, Spooner DM. Genetic Improvement of Solanaceous Crops Volume 2: Tomato. CRC Press; 2006. https://books.google.com/books?hl=en&lr=&id=1m7RBQAAQBAJ&pgis=1. Accessed December 18, 2015

ReferenceCitation: Manach C., Brennan L, Drasgted L.O. Metabolomics to evaluate food intake and utilization in nutritional epidemiology. In: Metabolomics as a Tool in Nutritional Research, Woodhead publishing 2015. pp.167-196

ReferenceCitation: Kesse-Guyot E, Castetbon K, Touvier M, Hercberg S, Galan P. Relative validity and reproducibility of a food frequency questionnaire designed for French adults. Ann Nutr Metab. 2010;57(3-4):153-62. doi: 10.1159/000321680. Epub 2010 Nov 16.

ReferenceCitation: Vázquez-Manjarrez N, Weinert CH, Ulaszewska MM, Mack CI, Micheau P, Pétéra M, Durand S, Pujos-Guillot E, Egert B, Mattivi F, Bub A, Dragsted LO, Kulling SE, Manach C. Discovery and Validation of Banana Intake Biomarkers Using Untargeted Metabolomics in Human Intervention and Cross-sectional Studies. J Nutr. 2019 Oct 1;149(10):1701-1713. doi: 10.1093/jn/nxz125.

name: Human Nutrition Unit, INRA, Université Clermont Auvergne, Clermont-Ferrand, France

name: Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark

family: Vázquez-Manjarrez

full_name: Natalia Vázquez-Manjarrez

given: Natalia

name: Department of Safety and Quality of Fruit and Vegetables, Max Rubner-Institut, Karlsruhe, Germany

family: Weinert

full_name: Christoph H Weinert

given: Christoph H

name: Department of Food Quality and Nutrition, Fondazione Edmund Mach, Research and Innovation Centre, San Michele all'Adige, Italy

family: Ulaszewska

full_name: Maria M Ulaszewska

given: Maria M

family: Mack

full_name: Carina I Mack

given: Carina I

family: Micheau

full_name: Pierre Micheau

given: Pierre

name: Human Nutrition Unit, Plateforme d'Exploration du Métabolisme MetaboHUB, INRA, Université Clermont Auvergne, Clermont-Ferrand, France

family: Pétéra

full_name: Mélanie Pétéra

given: Mélanie

family: Durand

full_name: Stephanie Durand

given: Stephanie

family: Pujos-Guillot

full_name: Estelle Pujos-Guillot

given: Estelle

family: Egert

full_name: Björn Egert

given: Björn

name: Centre of Agriculture Food Environment, University of Trento, San Michele all'Adige, Italy

family: Mattivi

full_name: Fulvio Mattivi

given: Fulvio

name: Department of Physiology and Biochemistry of Nutrition, Max Rubner-Institut, Karlsruhe, Germany

family: Bub

full_name: Achim Bub

given: Achim

family: Dragsted

full_name: Lars Ove Dragsted

given: Lars Ove

family: Kulling

full_name: Sabine E Kulling

given: Sabine E

family: Manach

full_name: Claudine Manach

given: Claudine

bso_classification: Biology (fond.)

journal_name: The Journal of Nutrition

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Claudine MANACH


title: Functional Study of the Hypothalamus in High-resolution Magnetic Resonance Imaging (MRI) in Women With Polycystic Ovary Syndrome (PCOS): a Comparative Study

acronym: MRI-PCOS

summary: The aim to evaluate whether activation of the hypothalamic-pituitary-gonadal axis in PCOS is associated with transient microstructural and metabolic changes in the female hypothalamus using MRI approaches to assess water diffusion and measure proton magnetic resonance spectra.

lead_sponsor: University Hospital, Lille


title: Platelet-associated Inflammation in Severe Sepsis

acronym: PlatISSep

summary: Sepsis represents a serious public health issue characterized by a complex inflammatory response. In addition to their hemostatic role, platelets display inflammatory functions by secreting a variety of immunomodulatory factors and interacting with circulating immune cells. The investigators postulate that, in severe sepsis, platelets become activated and release amounts of different soluble inflammatory molecules that contribute to sepsis-associated inflammation. First, the investigators propose to assess whether severe sepsis impairs the ability of platelets to release soluble CD40L (sCD40L), an powerful platelet-derived immunomodulatory molecule, in ICU patients with S. aureus documented infection, ICU patients with documented infection involving other bacterial species, compared to ICU patients with inflammation of noninfectious origin and healthy blood donors. Then, the investigators wish to assess whether the bacterial species affects the release of platelet sCD40L and by an extensive screening of platelet soluble factors, the investigators propose to set up profiles of inflammatory molecules associated with the type of infection. Finally, the investigators will analyze platelets' activation state and their association with circulating immune, according to the type of infection. Therefore, this project is expected to assess to which extent the platelet inflammatory function is super-activated in severe sepsis and to identify new platelet-related biomarkers of sepsis.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Executive Training and Brain in School-Age Children

acronym: APEX

summary: The purpose of this study is to determine whether a daily executive training to cognitive inhibition, working memory or mindfulness as compared to an active control condition has a near- and far-transfer impact on brain and behavioral measures as collected in children aged 9-10 years, either born preterm or full-term.

status: Unknown status

lead_sponsor: University Hospital, Caen

intervention_type: Procedure

status_simplified: Unknown


title: Biobank Based on the i-Share Student Cohort

acronym: bio-Share

summary: The bio-Share project aims at collecting blood samples in students participating in the i-Share cohort (www.i-share.fr). Investigators aim at setting up a platform that will enable investigators in the future to study biological determinants of conditions that affect young adults and to test certain hypotheses on the pathophysiology and mechanisms underlying diseases occurring both at a young age and later in life (as early exposures may also impact late onset diseases)

location_facility: Centre Hospitalier Universitaire de Bordeaux - PELLEGRIN


title: Toward Immune Biomarkers for Tolerance and GvHD in Humans

acronym: BioGvHD

summary:
Graft-versus-Host Disease (GVHD), is the most frequent and severe complication of allogeneic hematopoietic stem cell transplantation (HSCT). Much of our knowledge on the pathophysiology of GVHD has been gained from experimental models but far less from the study of the disease in humans. Recent developments in basic biology open new avenues to the development of biomarker sets that could predict GVHD severity and prognosis that could be tested and validated through well-designed multicenter clinical trials.

The main goal of this project is to further our understanding of the pathogenic mechanisms of human GVHD on one hand, and of functional immune tolerance on the other. Furthermore, this study aims at setting up a clinically relevant biomarker set in human GVHD and immune tolerance in a discovery cohort.

The objectives of this project are:

1. To define phenotypic, functional and molecular correlates of acute GVHD early after HSCT/at its onset 2. To study thymic reconstitution and the T-cell repertoire after HSCT during period 2 3. To identify functional and molecular correlates of immune tolerance in long-term survivors of HSCT 4. Preparing for biomarker validation into a clinical trial We propose a prospective analysis of a cohort of 680 patients transplanted from an HLA-identical sibling donor at Saint Louis hospital. Analyses will be performed during 3 critical, clinically relevant, periods.

Period 1: Analysis at the onset of GVHD, or at the time of engraftment 30 days after HSCT in patients not developing GVHD. An additional blood sample will also be analyzed 90 days after HSCT.
Period 2: Thymic function analysis using measurements of T-cell receptor excision circles (TREC) will be performed at 6 and 12 months post-transplant for all patients. T-cell receptor analysis on sorted T-cell populations will be performed by NGS.
Period 3: In "tolerant" patients (patients more than 2 years after HSCT not requiring immunosuppressive treatment), or in patients still requiring immunosuppressive therapy after 2 years. We will also analyze the corresponding immune parameters for each donor.

The longitudinal design of this study will allow us to provide an integrated view of GVHD pathophysiology and mechanisms of immune tolerance in human.

Prospectively identified phenotypic, molecular or functional biomarkers will then be tested, in a subsequent study, from biological materials prospectively collected within the French wide CryoStem cohort. Thus, as the final task of this project, we will perform statistical analyses taking into account confounding clinical variables influencing the outcome (i.e. GVHD-related death or tolerance). Preparing for a clinical trial will need moving from classical Bioinformatics analyses into clinically relevant statistical analyses that include sequential biological measurement in the discovery set cohort. Main points that will be taken into accounts for this task are the followings;

Transplant-related mortality (TRM) can be estimated in the range of 20%; 2year post-allogeneic HSCT
TRM is mostly (even if totally) due to GVHD and its associated immune deficiency
GVHD cumulative incidence can be estimated in the range of 40%
80 patients will be prospectively studied and 30 patients will be analyzed (cross sectional study) for part 3 only.
Since GVHD-related mortality and tolerance are mutually exclusive situation the optimal calculation for the validation cohort can be expected
This calculation will be the basis for the proposal of an interventional clinical trial.


title: A Pilot Study Assessing a New Eye-writing Device Allowing Cursive Writing With Smooth Pursuit Eye Movements in Subjects With ALS

acronym: ELY-SLA

summary: Eighteen ALS patients will be trained to control a new communication device (Eye On Line: EOL) that permit over smooth eye movements to generate digits, letters, words or drawing at will. The intervention consists in a training program during six visits over 3 weeks on site allowing a gradual acquisition of the eye-writing. The primary objective of the study is to assess the feasibility of the use of EOL device in ALS patients. The EOL device potentially offers a creative and personal means of linguistic and emotional expression in subject with motor disability.

intervention_type: Device


title: Study of the Renal Perfusion in Healthy Volunteers and Renal Transplant Recipients During an Orthostatic Stress

summary: Autonomic nervous system contributes to the regulation of renal blood flow, affected by upright posture. Kidney transplantation implies sympathetic denervation. The aim of this study is to compare the renal vascular response in volunteers and renal graft recipients to an orthostatic stress induced by a head-up tilt test. Renal peripheral resistances are assessed by echo Doppler. The sympathetic nervous system activity is evaluated by plasma concentrations of catecholamine before and after the head-up tilt test.

lead_sponsor: University Hospital, Angers


title: Dopamine Beta-hydroxylase Inhibition Induced Blunting of Dopaminergic Response to Psychostimulant Administration. A PET Exploration of the Mechanism of Action of a New Therapeutic Strategy in Cocaine Addicts

acronym: RAPID

summary: This study represents a randomized, double blind placebo-controlled trial. Thirty cocaine dependant patients will be included in this study during their hospitalization for withdrawal. After the inclusion visit, they will be randomized to receive disulfiram 250 mg/day or placebo over the 15 days of their hospitalization. Main outcome criteria will be evaluated during two TEP imaging sessions with 11Craclopride, before and after stimulation by methylphenidate, 8 to 15 days after randomization.

status: Withdrawn


summary:
Few is known on meat protein digestibility in humans and the impact of cooking process, while excessive intake of processed meat has been suggested to increase the risk of colorectal cancer.

This study aims to measure in vivo in humans the real digestibility of beef meat proteins depending 2 cooking processes, using ileal tubes and stable isotopes.

ReferenceCitation: Oberli M, Marsset-Baglieri A, Airinei G, Santé-Lhoutellier V, Khodorova N, Rémond D, Foucault-Simonin A, Piedcoq J, Tomé D, Fromentin G, Benamouzig R, Gaudichon C. High True Ileal Digestibility but Not Postprandial Utilization of Nitrogen from Bovine Meat Protein in Humans Is Moderately Decreased by High-Temperature, Long-Duration Cooking. J Nutr. 2015 Oct;145(10):2221-8. doi: 10.3945/jn.115.216838. Epub 2015 Aug 19.

name: French National Institute for Agricultural Research (INRA), Nutrition Physiology and Ingestive Behavior, Paris, France

name: AgroParisTech, Research Center for Human Nutrition Ilde de France, UMR914, Nutrition Physiology and Ingestive Behavior, Paris, France

family: Oberli

full_name: Marion Oberli

given: Marion

family: Marsset-Baglieri

full_name: Agnès Marsset-Baglieri

given: Agnès

family: Airinei

full_name: Gheorghe Airinei

given: Gheorghe

name: French National Institute for Agricultural Research (INRA), UR370 Quality of Animal Products, Saint Genès Champanelle, France

family: Santé-Lhoutellier

full_name: Véronique Santé-Lhoutellier

given: Véronique

family: Khodorova

full_name: Nadezda Khodorova

given: Nadezda

name: French National Institute for Agricultural Research (INRA), Unit of Human Nutrition, Research Center for Human Nutrition Auvergne, Clermont-Ferrand, France

name: Human Nutrition Unit, Clermont University, University d'Auvergne, Clermont-Ferrand, France

family: Rémond

full_name: Didier Rémond

given: Didier

family: Foucault-Simonin

full_name: Angélique Foucault-Simonin

given: Angélique

family: Piedcoq

full_name: Julien Piedcoq

given: Julien

family: Tomé

full_name: Daniel Tomé

given: Daniel

family: Fromentin

full_name: Gilles Fromentin

given: Gilles

family: Benamouzig

full_name: Robert Benamouzig

given: Robert

family: Gaudichon

full_name: Claire Gaudichon

given: Claire

oa_host_type: publisher

evidence: open (via free pdf)

license_normalized: no license

lead_sponsor: Institut National de la Recherche Agronomique

intervention_type: Dietary Supplement


title: Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population.

summary: The purpose of this study is to compare three different techniques of EEG recording for extraction of P300 Evoked Related Potentials (ERPs).

primary_purpose: Supportive Care

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


summary: Dietary protein differing by their amino acid composition could modulate undesirable metabolic and functional responses to a meal rich in saturated fat and sugars. This study aims at examining the specific effects of dairy protein with different cysteine contents on the postprandial undesirables effects elicited by the ingestion of a high fat meal in overweight subjects.

ReferenceCitation: Pujos-Guillot E, Brandolini-Bunlon M, Fouillet H, Joly C, Martin JF, Huneau JF, Dardevet D, Mariotti F. Metabolomics Reveals that the Type of Protein in a High-Fat Meal Modulates Postprandial Mitochondrial Overload and Incomplete Substrate Oxidation in Healthy Overweight Men. J Nutr. 2018 Jun 1;148(6):876-884. doi: 10.1093/jn/nxy049.

name: Université Clermont Auvergne, INRA, UNH, Unité de Nutrition Humaine, PFEM, MetaboHUB-Clermont, CRNH Auvergne, Clermont-Ferrand, France

family: Pujos-Guillot

full_name: Estelle Pujos-Guillot

given: Estelle

family: Brandolini-Bunlon

full_name: Marion Brandolini-Bunlon

name: UMR PNCA, AgroParisTech, INRA, Université Paris-Saclay, 75005, Paris, France

family: Fouillet

full_name: Hélène Fouillet

given: Hélène

family: Joly

full_name: Charlotte Joly

given: Charlotte

family: Martin

full_name: Jean-François Martin

given: Jean-François

family: Huneau

full_name: Jean-François Huneau

name: Université Clermont Auvergne, INRA, UNH, Unité de Nutrition Humaine, CRNH Auvergne, F-63000 Clermont-Ferrand, France

family: Dardevet

full_name: Dominique Dardevet

given: Dominique

family: Mariotti

full_name: François Mariotti

given: François

evidence: open (via free article)

ReferenceCitation: Mariotti F, Valette M, Lopez C, Fouillet H, Famelart MH, Mathé V, Airinei G, Benamouzig R, Gaudichon C, Tomé D, Tsikas D, Huneau JF. Casein Compared with Whey Proteins Affects the Organization of Dietary Fat during Digestion and Attenuates the Postprandial Triglyceride Response to a Mixed High-Fat Meal in Healthy, Overweight Men. J Nutr. 2015 Dec;145(12):2657-64. doi: 10.3945/jn.115.216812. Epub 2015 Oct 21.

name: AgroParisTech, CRNH-IdF, UMR914 Nutrition Physiology and Ingestive Behavior, Paris, France

name: INRA, CRNH-IdF, UMR914 Nutrition Physiology and Ingestive Behavior, Paris, France

family: Valette

full_name: Marion Valette

name: INRA, UMR1253 Science and Technology of Milk and Egg, Rennes, France

name: Agrocampus Ouest, UMR1253 Science and Technology of Milk and Egg, Rennes, France

family: Lopez

full_name: Christelle Lopez

given: Christelle

family: Famelart

full_name: Marie-Hélène Famelart

given: Marie-Hélène

family: Mathé

full_name: Véronique Mathé

name: Centre of Pharmacology and Toxicology, Hannover Medical School, Hannover, Germany

family: Tsikas

full_name: Dimitrios Tsikas

given: Dimitrios

full_name: Jean François Huneau


summary: Dietary protein is the more satiating nutrient, however it is not clear whether satiety may be influenced by the nature of the protein. This study was designed to assess potential differences between protein sources on satiety and their relationship with digestive and metabolic kinetics.

ReferenceCitation: Marsset-Baglieri A, Fromentin G, Airinei G, Pedersen C, Léonil J, Piedcoq J, Rémond D, Benamouzig R, Tomé D, Gaudichon C. Milk protein fractions moderately extend the duration of satiety compared with carbohydrates independently of their digestive kinetics in overweight subjects. Br J Nutr. 2014 Aug 28;112(4):557-64. doi: 10.1017/S0007114514001470. Epub 2014 Jun 26.

family: Marsset-Baglieri

full_name: Agnès Marsset-Baglieri

given: Agnès

full_name: Gilles Fromentin

family: Airinei

full_name: Gheorghe Airinei

given: Gheorghe

family: Pedersen

full_name: Camilla Pedersen

given: Camilla

family: Léonil

full_name: Joëlle Léonil

given: Joëlle

family: Piedcoq

full_name: Julien Piedcoq

family: Rémond

full_name: Didier Rémond

family: Tomé

full_name: Daniel Tomé

journal_name: British Journal of Nutrition

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

repository_normalized: HAL

version: submittedVersion

publisher: Cambridge University Press (CUP)

publisher_dissemination: Cambridge University Press

publisher_group: Cambridge University Press

publisher_normalized: Cambridge University Press

ReferenceCitation: Boutrou R, Gaudichon C, Dupont D, Jardin J, Airinei G, Marsset-Baglieri A, Benamouzig R, Tomé D, Leonil J. Sequential release of milk protein-derived bioactive peptides in the jejunum in healthy humans. Am J Clin Nutr. 2013 Jun;97(6):1314-23. doi: 10.3945/ajcn.112.055202. Epub 2013 Apr 10.

family: Boutrou

full_name: Rachel Boutrou

given: Rachel

family: Dupont

full_name: Didier Dupont

family: Jardin

full_name: Julien Jardin

journal_name: The American Journal of Clinical Nutrition

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

title: Sequential release of milk protein–derived bioactive peptides in the jejunum in healthy humans


title: Pilot Study in Cancer Patients Scheduled for Surgery Evaluating Different Smoking Cessation Protocols : Nicotine Replacement, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy

acronym: RESPIRE

summary: This trial offers support and assistance to patients wishing to quit smoking in order to increase the success rate of smoking cessation and all the benefits associated with it. Patients will be monitored by a tobacco specialist and will be able to benefit from one or more therapies complementary to Nicotine Replacement Therapy (NRT): Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Institut de Cancerologie de l'Ouest (ICO)


title: Perioperative Treatment in Resectable Gastric Cancer With Spartalizumab (PDR001) in Combination With Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel (FLOT): A Phase II Study (GASPAR)

acronym: GASPAR

summary: Multicenter, open-label, non randomized, phase 2 trial in resectable gastric or gastroesophageal junction adenocarcinoma: Perioperative Treatment by Spartalizumab (PDR001) in Combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT)

lead_sponsor: Centre Francois Baclesse


title: Randomized Multicentric Comparative Study Between a Conventional and an Intensive Follow up Strategy After Treatment of a Head and Neck Squamous Cell Carcinoma

acronym: SURVEILL'ORL

summary: Phase III randomized trial to compare the efficacy in terms of overall survival of two follow-up strategies (conventional versus intensive) among smokers and/or alcohol drinkers patients, older than 35 year, in complete remission 2-4 months after treatment of head and neck squamous cell carcinoma Patients will be randomized after the post-treatment check-up (clinical examination and reference imaging including PET-CT for patients ≥ N2) performed 2 to 4 months after the end of treatment. The randomization ratio is 1:1.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Randomized Phase 2 Trial Of Two Chemotherapy Regimens Plus Or Minus Bevacizumab In Patients With Well Differentiated Pancreatic Neuroendocrine Tumors

acronym: BETTER 2

summary: Compare the effect of capecitabine (cape) + temozolomide (temo) and of 5FU + streptozotocin (strepto) given with a new schedule (LV5FU2 + strepto), two of the most used chemotherapy regimens in the treatment of well differentiated pancreatic neuroendocrine tumors alone or in combination with bevacizumab (beva) on progression-free survival (PFS) and compare the chemotherapy regimens alone or with beva (two by two design) on the same criteria.


title: A Phase III Randomized Study of Chemo-radiotherapy Versus Radiotherapy Alone in the Adjuvant Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy)

acronym: SANTAL

summary:
A phase III, multicenter, randomized, open-label, french study comparing:

Arm A : Radiotherapy alone (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction) (IMRT or protontherapy)
Arm B: Radiotherapy (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction; IMRT or protontherapy) + concomitant cisplatin 100 mg/m2 IV on day 1 - J22 - 43 (3 cycles)

ReferenceCitation: Ferrari M, Orlandi E, Bossi P. Sinonasal cancers treatments: state of the art. Curr Opin Oncol. 2021 May 1;33(3):196-205. doi: 10.1097/CCO.0000000000000726. Review.

family: Ferrari

full_name: Marco Ferrari

given: Marco

family: Orlandi

full_name: Ester Orlandi

given: Ester

family: Bossi

full_name: Paolo Bossi

given: Paolo

journal_name: Current Opinion in Oncology

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Joshi NP, Broughman JR. Postoperative Management of Salivary Gland Tumors. Curr Treat Options Oncol. 2021 Feb 9;22(3):23. doi: 10.1007/s11864-021-00820-9. Review.

family: Joshi

full_name: Nikhil P. Joshi

given: Nikhil P.

family: Broughman

full_name: James R. Broughman

given: James R.

journal_name: Current Treatment Options in Oncology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

intervention_type: Radiation


title: Phase I Trial Evaluating the Safety of Durvalumab in Combination With Docetaxel, Cisplatin and 5-FU in Induction for Locally Advanced Head and Neck Squamous Cell Carcinoma

acronym: MEDINDUCTION

summary:
The prognosis of patients with locally advanced SCCHN is poor. Results of recent randomized trials evaluating induction chemotherapy by docetaxel, cisplatin, 5 fluorouracil are conflicting, and benefit on overall survival is uncertain. Improve efficacy of induction chemotherapy is important without increase toxicities. Durvalumab is a promising agent in SSCHN. The safety of combination of docetaxel, cisplatin, 5 fluorouracil with durvalumab is unknown.

The aim of the study is to evaluate the feasibility and the safety of the association of DCF (standard regimen for induction in SSCCHN) and durvalumab. The safety profile of DCF and durvalumab are different, so the expected toxicities should not be additive. The addition of durvalumab to DCF could improve the efficacy of induction chemotherapy and the prognostic of patients with SSCCHN.

Concerning the translational research, the aim will be to explore the relationships between immune capacity, specificity, activation state and clinical outcome to help elucidate the determinants of response to immunotherapy.


title: Allogenic Immunotherapy Based on Natural Killer Cell Adoptive Transfer in Metastatic Gastrointestinal Carcinoma Treated With Cetuximab : a Phase I Trial

summary:
Gastrointestinal (GI) cancers account for the most common cancers. Despite recent advances in GI cancer treatments, the 5-year overall survival rate for these patients remain unacceptable, except for patients who are candidates for metastasis surgical resection. Strategies leading to a decrease of metastatic number and size will contribute to improve the probability to undergo a curative surgical procedure.

Haploidentical Natural Killer (NK) cells can persist and expand in vivo following adoptive transfer and may have a role in the treatment of selected malignancies, since the failure to recognize the appropriate KIR ligand on a mismatched tumor cell can trigger NK cell elimination of that target cell. NK also express an activating Fc receptor that mediates antibody-dependent cellular cytotoxicity (ADCC) and production of immune modulatory cytokines in response to antibody-coated targets. Cetuximab, an IgG1 chimeric monoclonal antibody against colorectal cancers that expressed EGFR (epidermal growth factor receptor), improves overall survival and progression-free survival and preserves quality-of-life measures in patients with colorectal cancer in whom other treatments have failed.

In an attempt to improve the outcome in GI cancers, we will conduct a phase I/II clinical trial assessing NK cell based immunotherapy. Patients with liver metastases related to a EGFR+ GI cancer, previously treated by a standard chemotherapy that did not achieve a complete response or a curative resection of residual metastases will be included in this phase I/II trial supported by the French National Institute of Cancer (INCA, PHRC 2005). This phase I/II study will involve 22 patients. The main objective of this study will be to demonstrate the safety of NK hepatic intraarterial infusion in association with cetuximab. Secondary objectives will include the assessment of the clinical efficacity of this strategy.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Financial Incentive for Smoking Cessation in Pregnancy

acronym: FISCP

summary:
Maternal smoking during pregnancy (MSDP) increases the risk of adverse pregnancy and birth outcomes and may have long-lasting effects in the offspring.Financial incentives may increase smoking abstinence rate in pregnancy and therefore reduce MSDP related negative health effects. This is a randomized open label study comparing financial incentives for smoking abstinence with no financial incentives for smoking abstinence.Research objectives

To test the efficacy of financial incentives on smoking abstinence rate among pregnant smokers;
To explore the heterogeneity of efficacy according to individual characteristics: socioeconomic status, social background, smoking characteristics, personality traits, time and risk preferences to determine profiles of women which could benefit best from this kind of intervention;
To provide a cost-benefit analysis based on the cost of newborn and children disease due to maternal smoking during pregnancy.

ReferenceCitation: Berlin I, Berlin N, Malecot M, Breton M, Jusot F, Goldzahl L. Financial incentives for smoking cessation in pregnancy: multicentre randomised controlled trial. BMJ. 2021 Dec 1;375:e065217. doi: 10.1136/bmj-2021-065217.

ReferenceCitation: Berlin N, Goldzahl L, Jusot F, Berlin I. Protocol for study of financial incentives for smoking cessation in pregnancy (FISCP): randomised, multicentre study. BMJ Open. 2016 Jul 26;6(7):e011669. doi: 10.1136/bmjopen-2016-011669.

family: Berlin

full_name: Noémi Berlin

given: Noémi

family: Goldzahl

full_name: Léontine Goldzahl

given: Léontine

family: Jusot

full_name: Florence Jusot

given: Florence

full_name: Ivan Berlin

given: Ivan

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories:
HAL
PubMed Central
pure.ed.ac.uk

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal


title: Prospective National Multicentre Study to Validate a Model of Surgical Deescalation in Atypicals Breast Lesions

summary:
Routine screening mammography has increased the non-palpable suspicious lesion detection rate, requiring histopathological evaluation. The discovery of atypical lesions on the breast biopsy is associated with two interrelated risks:

The risk of underestimating the severity of the lesion biopsied currently leads systematically to achieve a surgical resection for these patients while a breast cancer (BC) will finally identified at surgery in 10 to 25% of cases. Thus, unnecessary surgeries will be performed in 75 to 90% of cases (no cancer).
These breast lesions confer long-term increase in the subsequent risk of breast cancer (cumulative incidence of 15 to 25% at 25 years). Thus, women identified with atypical lesions are then followed using clinical and mammographic annual evaluation.

The goal would be to get a model to assess the risk and no longer operate those patients at high risk of BC. Several groups have attempted to identify predictors of concurrent or secondary BC associated with the discovery of an unusual lesion at biopsy. However, they are often focused on a subtype of atypia (eg atypical metaplasia, atypical ductal hyperplasia, atypical lobular hyperplasia) and no prediction model has been validated in prospective multicenter. Based on a large retrospective study at Gustave Roussy, a prediction model (Nomat) has been developed, common to all atypical lesions, which can predict the presence of a BC at excision surgery (risk of concurrent BC). This model is based on the age of the patient, the disappearance of radiographic abnormalities (microcalcifications in general) after the biopsy and initial radiological lesion size. This model has good performance with an area under the curve (AUC) of 0.72. In previous series, with a BC high-risk threshold of 20%, negative predictive value was 90%, and this model would have prevented the surgery in 51% of patients (low risk patients by model). It is essential to validate this model by forward-looking and in different centers to ensure its relevance.

This is a multicenter prospective validation of the model on 300 patients operated for atypical lesions in 21 centers. All patients with atypical breast lesions have a routine surgery. The clinical data, imaging and histological data will be collected prospectively. The main objective of this study is to validate the model Nomat.

ReferenceCitation: Uzan C, Mazouni C, Rossoni C, De Korvin B, de Lara CT, Cohen M, Chabbert N, Zilberman S, Boussion V, Vincent Salomon A, Espie M, Coutant C, Marchal F, Salviat F, Boulanger L, Doutriaux-Dumoulin I, Jouve E, Mathelin C, de Saint Hilaire P, Mollard J, Balleyguier C, Joyon N, Triki ML, Delaloge S, Michiels S. Prospective Multicenter Study Validate a Prediction Model for Surgery Uptake Among Women with Atypical Breast Lesions. Ann Surg Oncol. 2021 Apr;28(4):2138-2145. doi: 10.1245/s10434-020-09107-z. Epub 2020 Sep 12.

family: Uzan

full_name: Catherine Uzan

given: Catherine

family: Mazouni

full_name: Chafika Mazouni

given: Chafika

family: Rossoni

full_name: Caroline Rossoni

given: Caroline

family: De Korvin

full_name: Brigitte De Korvin

given: Brigitte

family: de Lara

full_name: Christine Tunon de Lara

given: Christine Tunon

family: Cohen

full_name: Monique Cohen

given: Monique

family: Chabbert

full_name: Nathalie Chabbert

given: Nathalie

family: Zilberman

full_name: Sonia Zilberman

given: Sonia

family: Boussion

full_name: Veronique Boussion

given: Veronique

family: Vincent Salomon

full_name: Anne Vincent Salomon

given: Anne

family: Espie

full_name: Marc Espie

given: Marc

family: Coutant

full_name: Charles Coutant

given: Charles

family: Marchal

full_name: Frederic Marchal

given: Frederic

family: Salviat

full_name: Flore Salviat

given: Flore

family: Boulanger

full_name: Loic Boulanger

given: Loic

family: Doutriaux-Dumoulin

full_name: Isabelle Doutriaux-Dumoulin

given: Isabelle

family: Jouve

full_name: Eva Jouve

given: Eva

family: Mathelin

full_name: Carole Mathelin

given: Carole

family: de Saint hilaire

full_name: Pierre de Saint hilaire

given: Pierre

family: Mollard

full_name: Joelle Mollard

given: Joelle

family: Balleyguier

full_name: Corinne Balleyguier

given: Corinne

family: Joyon

full_name: Natacha Joyon

given: Natacha

family: Triki

full_name: Magali Lacroix Triki

given: Magali Lacroix

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

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

location_facility: Gustave Roussy Cancer Campus Grand Paris


title: Modulation of the Expression of Papillomavirus (HPV) Oncoproteins to Major the Radiosensitivity: Phase I Trial Combining an Antiviral Agent VISTIDE and Radiochemotherapy in Cervical Cancers

acronym: HPV-RX

summary: The treatment of cervical tumors depends on the stage of the disease. In advanced forms (nodal and / or local extension to the vagina and / or parameters) , radiotherapy associated with curietherapy , plays a major role. Until recently this association was the standard treatment for advanced stage uterine cancer. With this combination, rates of local failures (evolutionary prosecution and local recurrences) were 20 to 50% in stages IIb and 50-75 % for stage III. More than 50% for patients with a cervical cancer locally advanced (FIGO stages II / IV) . The standard treatment, external radiotherapy followed by curietherapy allows expect survival rates at 5 years for approximately 30-45 %. For ten years, numerous studies have evaluated the addition of concurrent chemotherapy to radiotherapy in cancer of the cervix. More than 19 randomized trials have been published. A meta-analysis of these trials was undertaken to assess the role of radiochemotherapy in cancers of the cervix. The first meta-analysis published by the Cochrane Collaborative Group, taking into account 4580 patient, shows an improvement in survival, both in terms of progression free survival and overall survival for patients treated with radio chemotherapy respectively 16% and 12 % (p < 0.0001). The rate of metastasis is also decreased (p < 0.0001). Survival rates were significantly better when platinum salt was used ( p < 0.0001 ) . However, no clinical benefit of chemoradiotherapy has been demonstrated for tumors stages [1, 2] locally advanced, possibly due to small number of patients. The investigators have previously shown that antiviral agents used in preclinical models, Cidofovir® causes the selective radiosensitization of cells infected by the papillomavirus (HPV). This trial proposes to study a new concept to increase radiochemotherapy efficiency: the modulation of the expression of viral oncoproteins HPV virus by an antiviral agent.


title: Postoperative Hepatic Arterial Chemotherapy in High-risk Patients as Adjuvant Treatment After Resection of Colorectal Liver Metastases - A Randomized Phase II/III Trial

summary:
Currently, no adjuvant study with hepatic arterial infusion in the adjuvant setting is opened. Recently, the results of a phase II study (NCT00268463, NSABP-C-09) assessing the potential benefit of systemic oxaliplatin and capecitabine alternating with HAI of FUDR, after resection of CRLM have been reported.

The primary end point was 2-year survival. Fifty-five of 76 eligible patients were able to initiate protocol-directed therapy and completed median of six cycles (range, one to six). Three postoperative or treatment-related deaths were reported. Overall, 88% of evaluable patients were alive at 2 years. With a median followup of 4.8 years, a total of 30 patients have had disease recurrence, 11 involving the liver. Median disease-free survival was 32.7 months. In conclusion alternating HAI of FUDR and systemic capecitabine and oxaliplatin met the prespecified end point of higher than 85% survival at 2 years and were clinically tolerable.

ReferenceCitation: Goéré D, Pignon JP, Gelli M, Elias D, Benhaim L, Deschamps F, Caramella C, Boige V, Ducreux M, de Baere T, Malka D. Postoperative hepatic arterial chemotherapy in high-risk patients as adjuvant treatment after resection of colorectal liver metastases - a randomized phase II/III trial - PACHA-01 (NCT02494973). BMC Cancer. 2018 Aug 6;18(1):787. doi: 10.1186/s12885-018-4697-7.

family: Goéré

full_name: Diane Goéré

given: Diane

family: Pignon

full_name: Jean-Pierre Pignon

given: Jean-Pierre

family: Gelli

full_name: Maximiliano Gelli

given: Maximiliano

family: Elias

full_name: Dominique Elias

given: Dominique

family: Benhaim

full_name: Léonor Benhaim

given: Léonor

family: Deschamps

full_name: Frédéric Deschamps

given: Frédéric

family: Caramella

full_name: Caroline Caramella

given: Caroline

family: Boige

full_name: Valérie Boige

given: Valérie

family: Ducreux

full_name: Michel Ducreux

given: Michel

family: de Baere

full_name: Thierry de Baere

given: Thierry

family: Malka

full_name: David Malka

given: David

journal_name: BMC Cancer

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

repositories:
HAL
PubMed Central

title: Postoperative hepatic arterial chemotherapy in high-risk patients as adjuvant treatment after resection of colorectal liver metastases - a randomized phase II/III trial – PACHA-01 (NCT02494973)


acronym: CARBONOMIC

summary: The purpose of the study is to follow tumoral proteins metabolism by in vivo no radioactive isotopic tagging (carbon 13 and nitrogen 15).

status: Terminated


title: Quantification, Analysis and Simulation of Facial Mimics Movements

acronym: SIMOVI-IRM

summary:
The SIMOVI project is a collaboration between our Department of Maxillofacial Surgery (CHU Amiens) and the Biomechanical bioengineer Research Department and Roberval Labs (Technological University of Compiègne). The question raised is the extent to which a facial mimic can be evaluated objectively. In today's clinical practice, the investigators use grading systems based on muscular scale or testing, in order to evaluate a facial muscular disorder. This assessment remains subjective because the investigators are deducing from surfacing cutaneous deformations the movement quality of the solicited muscle.

This qualitative approach is therefore an approximate approach and deserves to be better thought to plan a surgical treatment which involves mimic facial muscle (as rehabilitation of facial palsy, cleft palate for example), to monitor the results, and to follow the recovery and progress in physiotherapy care.

The aim of this study is to correlate external soft tissue movement (essentially cutaneous) during facial mimic with internal movement (essentially facial mimic muscle) using qualitative and QUANTITATIVE indicators, and to perform a biomechanical model of selected mimic face's movement using the precedent data.

ReferenceCitation: Autuori B, Bruyère-Garnier K, Morestin F, Brunet M, Verriest JP. Finite element modeling of the head skeleton with a new local quantitative assessment approach. IEEE Trans Biomed Eng. 2006 Jul;53(7):1225-32.

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lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Evaluation of the Diagnostic Performance of MRI±Biopsy to Optimize Resection of Ductal Carcinoma In Situ (DCIS) Breast Cancer

acronym: IRCIS

summary: The purpose of this study is to evaluate the diagnostic performance of MRI±biopsy to optimize resection of Ductal Carcinoma In Situ (DCIS) breast cancer.

ReferenceCitation: Balleyguier C, Dunant A, Ceugnart L, Kandel M, Chauvet MP, Chérel P, Mazouni C, Henrot P, Rauch P, Chopier J, Zilberman S, Doutriaux-Dumoulin I, Jaffre I, Jalaguier A, Houvenaeghel G, Guérin N, Callonnec F, Chapellier C, Raoust I, Mathieu MC, Rimareix F, Bonastre J, Garbay JR. Preoperative Breast Magnetic Resonance Imaging in Women With Local Ductal Carcinoma in Situ to Optimize Surgical Outcomes: Results From the Randomized Phase III Trial IRCIS. J Clin Oncol. 2019 Apr 10;37(11):885-892. doi: 10.1200/JCO.18.00595. Epub 2019 Feb 27.

family: Dunant

full_name: Ariane Dunant

given: Ariane

family: Ceugnart

full_name: Luc Ceugnart

given: Luc

name: Université Paris-Saclay, Villejuif, France

family: Kandel

full_name: Marguerite Kandel

given: Marguerite

family: Chauvet

full_name: Marie-Pierre Chauvet

given: Marie-Pierre

name: René Huguenin/Curie, Saint-Cloud, France

family: Chérel

full_name: Pascal Chérel

given: Pascal

family: Mazouni

full_name: Chafika Mazouni

given: Chafika

name: Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, France

family: Henrot

full_name: Philippe Henrot

given: Philippe

family: Rauch

full_name: Philippe Rauch

family: Chopier

full_name: Jocelyne Chopier

given: Jocelyne

family: Zilberman

full_name: Sonia Zilberman

given: Sonia

name: Institut de Cancérologie de l'Ouest, Nantes, France

family: Doutriaux-Dumoulin

full_name: Isabelle Doutriaux-Dumoulin

given: Isabelle

family: Jaffre

full_name: Isabelle Jaffre

name: Institut Paoli Calmettes, Marseille, France

family: Jalaguier

full_name: Aurélie Jalaguier

given: Aurélie

name: Cancer Research Center of Marseille, Marseille, France

name: Aix-Marseille Université, Marseille, France

family: Houvenaeghel

full_name: Gilles Houvenaeghel

given: Gilles

family: Guérin

full_name: Nicole Guérin

given: Nicole

family: Callonnec

full_name: Françoise Callonnec

given: Françoise

family: Chapellier

full_name: Claire Chapellier

given: Claire

family: Raoust

full_name: Ines Raoust

given: Ines

family: Mathieu

full_name: Marie-Christine Mathieu

given: Marie-Christine

family: Rimareix

full_name: Françoise Rimareix

family: Bonastre

full_name: Julia Bonastre

given: Julia

family: Garbay

full_name: Jean-Rémi Garbay

given: Jean-Rémi

publisher: American Society of Clinical Oncology (ASCO)


title: Validation of a Screening Tool in Geriatric Oncology

acronym: ONCODAGE

summary:
RATIONALE: A screening questionnaire may help doctors plan better treatment for older patients with cancer.

PURPOSE: This clinical trial is studying a questionnaire in screening older patients with cancer.

primary_purpose: Screening

ReferenceCitation: Bellera CA, Artaud F, Rainfray M, Soubeyran PL, Mathoulin-Pélissier S. Modeling individual and relative accuracy of screening tools in geriatric oncology. Ann Oncol. 2017 May 1;28(5):1152-1157. doi: 10.1093/annonc/mdx068.

ReferenceType: result

ReferenceCitation: Soubeyran P, Bellera C, Goyard J, Heitz D, Curé H, Rousselot H, Albrand G, Servent V, Jean OS, van Praagh I, Kurtz JE, Périn S, Verhaeghe JL, Terret C, Desauw C, Girre V, Mertens C, Mathoulin-Pélissier S, Rainfray M. Screening for vulnerability in older cancer patients: the ONCODAGE Prospective Multicenter Cohort Study. PLoS One. 2014 Dec 11;9(12):e115060. doi: 10.1371/journal.pone.0115060. eCollection 2014.

family: Soubeyran

full_name: Pierre Soubeyran

given: Pierre

family: Bellera

full_name: Carine Bellera

given: Carine

family: Goyard

full_name: Jean Goyard

given: Jean

family: Heitz

full_name: Damien Heitz

given: Damien

family: Curé

full_name: Hervé Curé

given: Hervé

family: Rousselot

full_name: Hubert Rousselot

given: Hubert

family: Albrand

full_name: Gilles Albrand

family: Servent

full_name: Véronique Servent

given: Véronique

family: Jean

full_name: Olivier Saint Jean

given: Olivier Saint

family: van Praagh

full_name: Isabelle van Praagh

family: Kurtz

full_name: Jean-Emmanuel Kurtz

given: Jean-Emmanuel

family: Périn

full_name: Stéphane Périn

given: Stéphane

family: Verhaeghe

full_name: Jean-Luc Verhaeghe

given: Jean-Luc

family: Terret

full_name: Catherine Terret

given: Catherine

family: Desauw

full_name: Christophe Desauw

given: Christophe

family: Girre

full_name: Véronique Girre

family: Mertens

full_name: Cécile Mertens

given: Cécile

family: Mathoulin-Pélissier

full_name: Simone Mathoulin-Pélissier

given: Simone

family: Rainfray

full_name: Muriel Rainfray

given: Muriel

currency_apc_doaj: USD

journal_name: PLoS ONE

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

repositories:
PubMed Central
pdfs.semanticscholar.org
univOAK

title: Screening for Vulnerability in Older Cancer Patients: The ONCODAGE Prospective Multicenter Cohort Study