title: French Registry of Acute Coronary Syndrome With or Without ST Elevation

acronym: Fast-MI

summary: The Fast-MI registry was designed to evaluate the "real world" management of patients with acute myocardial infarction (MI), and to assess their in-hospital, medium and long-term outcomes

ReferenceCitation: Hasdai D, Lev EI, Behar S, Boyko V, Danchin N, Vahanian A, Battler A. Acute coronary syndromes in patients with pre-existing moderate to severe valvular disease of the heart: lessons from the Euro-Heart Survey of acute coronary syndromes. Eur Heart J. 2003 Apr;24(7):623-9.

ReferenceCitation: Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet. 1994 Nov 19;344(8934):1383-9.

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: Schwartz GG, Olsson AG, Ezekowitz MD, Ganz P, Oliver MF, Waters D, Zeiher A, Chaitman BR, Leslie S, Stern T; Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial. JAMA. 2001 Apr 4;285(13):1711-8.

ReferenceCitation: Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, Skene AM; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 Investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004 Apr 8;350(15):1495-504. Epub 2004 Mar 8. Erratum in: N Engl J Med. 2006 Feb 16;354(7):778.

ReferenceCitation: Gustafsson I, Torp-Pedersen C, Køber L, Gustafsson F, Hildebrandt P. Effect of the angiotensin-converting enzyme inhibitor trandolapril on mortality and morbidity in diabetic patients with left ventricular dysfunction after acute myocardial infarction. Trace Study Group. J Am Coll Cardiol. 1999 Jul;34(1):83-9.

ReferenceCitation: Torp-Pedersen C, Køber L. Effect of ACE inhibitor trandolapril on life expectancy of patients with reduced left-ventricular function after acute myocardial infarction. TRACE Study Group. Trandolapril Cardiac Evaluation. Lancet. 1999 Jul 3;354(9172):9-12.

ReferenceCitation: Pedersen OD, Bagger H, Kober L, Torp-Pedersen C. Trandolapril reduces the incidence of atrial fibrillation after acute myocardial infarction in patients with left ventricular dysfunction. Circulation. 1999 Jul 27;100(4):376-80.

ReferenceCitation: Hall AS, Murray GD, Ball SG. Follow-up study of patients randomly allocated ramipril or placebo for heart failure after acute myocardial infarction: AIRE Extension (AIREX) Study. Acute Infarction Ramipril Efficacy. Lancet. 1997 May 24;349(9064):1493-7.

ReferenceCitation: Koren MJ, Hunninghake DB; ALLIANCE Investigators. Clinical outcomes in managed-care patients with coronary heart disease treated aggressively in lipid-lowering disease management clinics: the alliance study. J Am Coll Cardiol. 2004 Nov 2;44(9):1772-9.

ReferenceCitation: Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med. 1998 Nov 5;339(19):1349-57.

ReferenceCitation: Global Use of Strategies to Open Occluded Coronary Arteries in Acute Coronary Syndromes (GUSTO IIb) Angioplasty Substudy Investigators. A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction. N Engl J Med. 1997 Jun 5;336(23):1621-8. Erratum in: N Engl J Med 1997 Jul 24;337(4):287.

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: Vaur L, Danchin N, Genès N, Dubroca I, Etienne S, Ferrières J, Cambou JP. Epidemiology of myocardial infarction in France: therapeutic and prognostic implications of heart failure during the acute phase. Am Heart J. 1999 Jan;137(1):49-58.

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: 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: Schiele F, Puymirat E, Ferrières J, Simon T, Fox KAA, Eikelboom J, Danchin N; FAST-MI investigators. The FAST-MI 2005-2010-2015 registries in the light of the COMPASS trial: The COMPASS criteria applied to a post-MI population. Int J Cardiol. 2019 Mar 1;278:7-13. doi: 10.1016/j.ijcard.2018.11.138. Epub 2018 Dec 3.

family: Schiele

full_name: François Schiele

given: François

family: Puymirat

full_name: Etienne Puymirat

given: Etienne

family: Ferrières

full_name: Jean Ferrières

given: Jean

family: Simon

full_name: Tabassome Simon

given: Tabassome

family: Fox

full_name: Keith A.A. Fox

given: Keith A.A.

family: Eikelboom

full_name: John Eikelboom

given: John

family: Danchin

full_name: Nicolas Danchin

given: Nicolas

journal_name: International Journal of Cardiology

oa_colors: green hybrid

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

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

ReferenceCitation: Danchin N, Puymirat E, Cayla G, Cottin Y, Coste P, Gilard M, Goldstein P, Braun F, Belle L, Montalescot G, Ferrières J, Schiele F, Simon T; FAST-MI Investigators. One-Year Survival After ST-Segment-Elevation Myocardial Infarction in Relation With Prehospital Administration of Dual Antiplatelet Therapy. Circ Cardiovasc Interv. 2018 Sep;11(9):e007241. doi: 10.1161/CIRCINTERVENTIONS.118.007241.

name: Department of Cardiology, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, France (N.D., E.P.).

name: Université Paris-Descartes, France (N.D., E.P.).

name: INSERM U-970, Paris, France (N.D., E.P.).

name: Department of Cardiology, Centre Hospitalier Universitaire de Nîmes, Université de Montpellier, France (G.C.).

name: Department of Cardiology, Centre Hospitalier Universitaire du Bocage, Dijon, France (Y.C.).

name: Department of Cardiology, Hôpital Cardiologique du Haut-Lévêque, CHU de Bordeaux, Pessac, France (P.C.).

name: Département de Cardiologie CHU La Cavale Blanche, Brest, France (M.G.).

name: Société Française de Cardiologie, Paris, France (M.G.).

name: Emergency Department, Lille Regional University Hospital, France (P.G.).

name: Emergency Department, Centre Hospitalier Régional, Hôpital Mercy, Metz, France (F.B.).

name: Department of Cardiology, Centre Hospitalier Annecy Genevois, Epagny Metz-Tessy, France (L.B.).

name: Collège National des Cardiologues des Hôpitaux, Paris, France (L.B.).

name: Institut de Cardiologie, Centre Hospitalier Pitié-Salpêtrière, Paris, France (G.M.).

name: Department of Cardiology, Toulouse Rangueil University Hospital, France (J.F.).

name: UMR1027, INSERM, Toulouse, France (J.F.).

name: Department of Cardiology, University Hospital Jean Minjoz, Besançon, France (F.S.).

name: Department of Clinical Pharmacology and Unité de Recherche Clinique (URCEST), AP-HP, Hôpital Saint Antoine, Paris, France (T.S.).

name: Université Pierre et Marie Curie (UPMC-Paris 06), France (T.S.).

title: One-Year Survival After ST-Segment–Elevation Myocardial Infarction in Relation With Prehospital Administration of Dual Antiplatelet Therapy

ReferenceCitation: Puymirat E, Riant E, Aissaoui N, Soria A, Ducrocq G, Coste P, Cottin Y, Aupetit JF, Bonnefoy E, Blanchard D, Cattan S, Steg G, Schiele F, Ferrières J, Juillière Y, Simon T, Danchin N. β blockers and mortality after myocardial infarction in patients without heart failure: multicentre prospective cohort study. BMJ. 2016 Sep 20;354:i4801. doi: 10.1136/bmj.i4801. Erratum in: BMJ. 2016 Oct 17;355:i5602.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Puymirat E, Schiele F, Zeller M, Jacquemin L, Leclercq F, Marcaggi X, Ferrières J, Simon T, Danchin N; FAST-MI investigators. Do randomized clinical trial selection criteria reflect levels of risk as observed in a general population of acute myocardial infarction survivors? The PEGASUS trial in the light of the FAST-MI 2005 registry. Int J Cardiol. 2016 Nov 15;223:604-610. doi: 10.1016/j.ijcard.2016.08.191. Epub 2016 Aug 16.

ReferenceCitation: Feldman L, Steg PG, Amsallem M, Puymirat E, Sorbets E, Elbaz M, Ritz B, Hueber A, Cattan S, Piot C, Ferrières J, Simon T, Danchin N; FAST-MI investigators. Editor's Choice-Medically managed patients with non-ST-elevation acute myocardial infarction have heterogeneous outcomes, based on performance of angiography and extent of coronary artery disease. Eur Heart J Acute Cardiovasc Care. 2017 Apr;6(3):262-271. doi: 10.1177/2048872615626354. Epub 2016 Jan 12.

name: Département de Cardiologie, Hôpital Bichat, Assistance Publique Hôpitaux de Paris (APHP), France

name: French Alliance for Cardiovascular Clinical Trials (FACT), France

name: Imperial College, Royal Brompton Hospital, London, UK

name: Hôpital Européen Georges Pompidou, APHP, France

name: U1148, Institut National de la Santé et de la Recherche Médicale (INSERM) INSERM, France

name: Hôpital St Joseph et St Luc, Lyon, France

name: Clinique du Millénaire, Montpellier, France

name: Département de Pharmacologie Clinique, Hôpital Saint-Antoine, APHP, France

name: Université Pierre et Marie Curie, France

journal_name: European Heart Journal: Acute Cardiovascular Care

title: Editor’s Choice-Medically managed patients with non–ST-elevation acute myocardial infarction have heterogeneous outcomes, based on performance of angiography and extent of coronary artery disease

ReferenceCitation: Pouche M, Ruidavets JB, Ferrières J, Iliou MC, Douard H, Lorgis L, Carrié D, Brunel P, Simon T, Bataille V, Danchin N. Cardiac rehabilitation and 5-year mortality after acute coronary syndromes: The 2005 French FAST-MI study. Arch Cardiovasc Dis. 2016 Mar;109(3):178-87. doi: 10.1016/j.acvd.2015.09.009. Epub 2015 Dec 23.

title: Cardiac rehabilitation and 5-year mortality after acute coronary syndromes: The 2005 French FAST-MI study

ReferenceCitation: Puymirat E, Lamhaut L, Bonnet N, Aissaoui N, Henry P, Cayla G, Cattan S, Steg G, Mock L, Ducrocq G, Goldstein P, Schiele F, Bonnefoy-Cudraz E, Simon T, Danchin N. Correlates of pre-hospital morphine use in ST-elevation myocardial infarction patients and its association with in-hospital outcomes and long-term mortality: the FAST-MI (French Registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction) programme. Eur Heart J. 2016 Apr 1;37(13):1063-71. doi: 10.1093/eurheartj/ehv567. Epub 2015 Nov 17.

ReferenceCitation: Donataccio MP, Puymirat E, Parapid B, Steg PG, Eltchaninoff H, Weber S, Ferrari E, Vilarem D, Charpentier S, Manzo-Silberman S, Ferrières J, Danchin N, Simon T. In-hospital outcomes and long-term mortality according to sex and management strategy in acute myocardial infarction. Insights from the French ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) 2005 Registry. Int J Cardiol. 2015 Dec 15;201:265-70. doi: 10.1016/j.ijcard.2015.08.065. Epub 2015 Aug 8.

ReferenceCitation: Aissaoui N, Puymirat E, Simon T, Bonnefoy-Cudraz E, Angoulvant D, Schiele F, Benamer H, Quandalle P, Prunier F, Durand E, Berard L, Blanchard D, Danchin N. Long-term outcome in early survivors of cardiogenic shock at the acute stage of myocardial infarction: a landmark analysis from the French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) Registry. Crit Care. 2014 Sep 19;18(5):516. doi: 10.1186/s13054-014-0516-y.

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

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

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

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

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.);...

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

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: Simon T, Taleb S, Danchin N, Laurans L, Rousseau B, Cattan S, Montely JM, Dubourg O, Tedgui A, Kotti S, Mallat Z. Circulating levels of interleukin-17 and cardiovascular outcomes in patients with acute myocardial infarction. Eur Heart J. 2013 Feb;34(8):570-7. doi: 10.1093/eurheartj/ehs263. Epub 2012 Sep 6.

title: Circulating levels of interleukin-17 and cardiovascular outcomes in patients with acute myocardial infarction

ReferenceCitation: Puymirat É, Aissaoui N, Silvain J, Bonello L, Cuisset T, Motreff P, Bataille V, Durand E, Cottin Y, Simon T, Danchin N; FAST-MI investigators. Comparison of bleeding complications and 3-year survival with low-molecular-weight heparin versus unfractionated heparin for acute myocardial infarction: the FAST-MI registry. Arch Cardiovasc Dis. 2012 Jun-Jul;105(6-7):347-54. doi: 10.1016/j.acvd.2012.04.002. Epub 2012 Jun 27.

title: Comparison of bleeding complications and 3-year survival with low-molecular-weight heparin versus unfractionated heparin for acute myocardial infarction: The FAST-MI registry

ReferenceCitation: Juillière Y, Cambou JP, Bataille V, Mulak G, Galinier M, Gibelin P, Benamer H, Bouvaist H, Méneveau N, Tabone X, Simon T, Danchin N; FAST-MI Investigators. Heart failure in acute myocardial infarction: a comparison between patients with or without heart failure criteria from the FAST-MI registry. Rev Esp Cardiol (Engl Ed). 2012 Apr;65(4):326-33. doi: 10.1016/j.recesp.2011.10.027. Epub 2012 Feb 20.

title: Insuficiencia cardiaca en el infarto agudo de miocardio: comparación de pacientes con o sin criterios de insuficiencia cardiaca del registro FAST-MI

ReferenceCitation: Simon T, Steg PG, Gilard M, Blanchard D, Bonello L, Hanssen M, Lardoux H, Coste P, Lefèvre T, Drouet E, Mulak G, Bataille V, Ferrières J, Verstuyft C, Danchin N. Clinical events as a function of proton pump inhibitor use, clopidogrel use, and cytochrome P450 2C19 genotype in a large nationwide cohort of acute myocardial infarction: results from the French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) registry. Circulation. 2011 Feb 8;123(5):474-82. doi: 10.1161/CIRCULATIONAHA.110.965640. Epub 2011 Jan 24.

name: From the Assistance Publique-Hôpitaux de Paris, URC-EST, Hôpital St. Antoinel, Paris (T.S., E.D.); UPMC-Paris 06 University, Paris (T.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Université Paris 7–Denis Diderot, INSERM U-698, Paris (P.G.S.); Centre Hospitalier Universitaire, Brest (M.G.); Clinique St Gatien, Tours and Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Paris (D.B.); Hôpital Nord, Marseille (L.B.); Centre Hospitalier, Haguenau (M.H.); Centre...

title: Clinical Events as a Function of Proton Pump Inhibitor Use, Clopidogrel Use, and Cytochrome P450 2C19 Genotype in a Large Nationwide Cohort of Acute Myocardial Infarction

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


title: Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients

acronym: TACA

summary: The purpose of this study is to determine whether adjunction of intravenous anticoagulant therapy (enoxaparin, HNF, bivalirudin) to antiaggregation with clopidogrel and aspirin improves in-hospital results of percutaneous transluminal coronary angioplasty (ptca) in selected patients.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Centre Hospitalier de PAU

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


title: PKPOP Study of Didanosine in HIV Treated Children, at Fasting Period and During the Meal

acronym: ddI

summary: The purpose of this study is to show that the administration of 400/mg/m2/day of didanosine(ddI) during the meal is bioequivalent to the administration of 240/mg/m2/day of didanosine during fasting, in HIV infected children treated by a ARV combination including ddI

status: Suspended

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Assessment of the Clinical Symptoms of the Primary Pigmented Nodular Adrenocortical Disease (PPNAD) and the CARNEY Complex (CNC).

acronym: EVACARNEY

summary: Cohort CNC-PPNAD will be investigated with clinical, genetic, biological and imaging work-up every year during 3 years. Cohort L-MC will be investigated clinically at inclusion and a PERKAR1A genotype will be performed.

status: Completed

study_type: Observational

ReferenceType: result

ReferenceCitation: Bertherat J. Carney complex (CNC). Orphanet J Rare Dis. 2006 Jun 6;1:21. Review.

ReferenceCitation: Kirschner LS, Carney JA, Pack SD, Taymans SE, Giatzakis C, Cho YS, Cho-Chung YS, Stratakis CA. Mutations of the gene encoding the protein kinase A type I-alpha regulatory subunit in patients with the Carney complex. Nat Genet. 2000 Sep;26(1):89-92.

ReferenceCitation: Carney JA, Gordon H, Carpenter PC, Shenoy BV, Go VL. The complex of myxomas, spotty pigmentation, and endocrine overactivity. Medicine (Baltimore). 1985 Jul;64(4):270-83.

ReferenceType: derived

ReferenceCitation: Espiard S, Vantyghem MC, Assié G, Cardot-Bauters C, Raverot G, Brucker-Davis F, Archambeaud-Mouveroux F, Lefebvre H, Nunes ML, Tabarin A, Lienhardt A, Chabre O, Houang M, Bottineau M, Stroër S, Groussin L, Guignat L, Cabanes L, Feydy A, Bonnet F, North MO, Dupin N, Grabar S, Duboc D, Bertherat J. Frequency and Incidence of Carney Complex Manifestations: A Prospective Multicenter Study With a Three-Year Follow-Up. J Clin Endocrinol Metab. 2020 Mar 1;105(3). pii: dgaa002. doi: 10.1210/clinem/dgaa002.

name: INSERM U1016, CNRS UMR8104, Institut Cochin, Université Paris Descartes, Paris

name: Service d’Endocrinologie, Centre de référence des maladies rares de la surrénale, Assistance Publique Hôpitaux de Paris, Hôpital Cochin, Paris, France

name: Service d’endocrinologie, diabétologie, métabolisme et nutrition, CHR-U de Lille, Hôpital Huriez, Lille, France

family: Espiard

full_name: Stéphanie Espiard

given: Stéphanie

sequence: first

family: Vantyghem

full_name: Marie-Christine Vantyghem

given: Marie-Christine

sequence: additional

family: Assié

full_name: Guillaume Assié

given: Guillaume

family: Cardot-Bauters

full_name: Catherine Cardot-Bauters

given: Catherine

name: Fédération d’endocrinologie, groupement Hospitalier Est, Hospices Civils de Lyon, Bron, France

family: Raverot

full_name: Gerald Raverot

given: Gerald

name: Service d’endocrinologie, diabétologie et médecine de la reproduction, CHU de Nice, Nice, France

family: Brucker-Davis

full_name: Françoise Brucker-Davis

given: Françoise

name: Service d’endocrinologie, CHU de Limoges, Hôpital Le Cluzeau, Limoges, France

family: Archambeaud-Mouveroux

full_name: Françoise Archambeaud-Mouveroux

name: Service d’endocrinologie, diabète et maladie métabolique, CHU de Rouen, Rouen, France

family: Lefebvre

full_name: Hervé Lefebvre

given: Hervé

name: Service d’endocrinologie, diabétologie et maladies métaboliques, Faculté de médecine Bordeaux-Victor-Ségalen, CHU de Bordeaux, Hôpital Haut-Lévêque, Pessac, France

family: Nunes

full_name: Marie-Laure Nunes

given: Marie-Laure

family: Tabarin

full_name: Antoine Tabarin

given: Antoine

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

family: Lienhardt

full_name: Anne Lienhardt

given: Anne

name: Service d’Endocrinologie, CHU Grenoble Alpes and Université Grenoble Alpes, Grenoble, France

family: Chabre

full_name: Olivier Chabre

given: Olivier

name: Service d’endocrinologie pédiatrique, CHU Paris Est, Hôpital d’Enfants Armand-Trousseau, Paris, France

family: Houang

full_name: Muriel Houang

given: Muriel

name: Université Paris Descartes, Sorbonne Paris Cité AP-HP, Unité de Biostatistique et Epidémiologie, Groupe Hospitalier Cochin Broca Hôtel-Dieu, Paris, France

family: Bottineau

full_name: Muriel Bottineau

name: Service de Radiologie B, AP-HP, Hôpital Cochin, Paris, France

family: Stroër

full_name: Sebastian Stroër

given: Sebastian

family: Groussin

full_name: Lionel Groussin

given: Lionel

family: Guignat

full_name: Laurence Guignat

given: Laurence

name: Service de Cardiologie, Hôpital Cochin, APHP, Université Paris Descartes-Sorbonne Paris Cité, Paris, France

family: Cabanes

full_name: Laure Cabanes

given: Laure

family: Feydy

full_name: Antoine Feydy

name: Service d’Hormonologie, Assistance Publique Hôpitaux de Paris, Hôpital Cochin, Paris, France

family: Bonnet

full_name: Fidéline Bonnet

given: Fidéline

name: Service d’Oncogénétique, Assistance Publique Hôpitaux de Paris, Hôpital Cochin, Paris, France

family: North

full_name: Marie Odile North

given: Marie Odile

name: Service de Dermatologie, Hôpital Cochin, Assistance publique - Hôpitaux de Paris, Paris, France

family: Dupin

full_name: Nicolas Dupin

family: Grabar

full_name: Sophie Grabar

given: Sophie

journal_name: The Journal of Clinical Endocrinology & Metabolism


title: Facial Expression Recognition of Emotion and Categorization of Emotional Words in Gilles de la Tourette's Syndrome

summary:
Gilles de la Tourette's syndrome is a childhood onset inherited neuropsychiatric disorder characterised by the presence of both multiple motor tics and one or more vocal tics (noises), with psychiatric and/or behaviour disorders (such as obsessive compulsive behaviour…).

This disease is associated with an dopamine system imbalance which could be responsible of a specific trouble in the recognition in some facial expression. This has been already shown in Gilles de la Tourette patients with obsessive compulsive behaviour.

We hypothesise that patients with Gilles de la Tourette's syndrome present a dysfunction of voluntary and automatic treatment of emotional information.

The main purpose of this study is to show if patients with Gilles de la Tourette's syndrome present a lack of specific facial expression recognition of emotion and determinate more precisely if this alteration involves the cortical way (high frequency way) or the under cortical way (low frequency way).

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral

status_simplified: Completed


title: Facial Expression Recognition of Emotion and Categorization of Emotional Words in Parkinson's Disease. Impact of L-Dopa and Deep Brain Stimulation of Subthalamic Nucleus .

summary:
Parkinson'disease is a neurodegenerative disorder characterised by bradykinesia, rigidity, rest tremor and postural instability. Dopaminergic therapy such as L-Dopa and dopamine agonists usually leads to a dramatic improvement of symptoms, but disease progression nevertheless remains inevitable. Bilateral Deep brain stimulation in subthalamic nucleus is now considered the gold standard surgical treatment.

Parkinson'disease mainly affects the nigrostriatal dopaminergic system which is linked to the limbic system and could be responsible of a specific trouble in the recognition in some facial expression.

We hypothesise that patients with Parkinson'disease present a dysfunction of voluntary and automatic treatment of emotional information.

The main purpose of this study is to show if patients with Parkinson'disease present a lack of specific facial expression recognition of emotion and determinate more precisely if this alteration involves the cortical way (high frequency way) or the under cortical way (low frequency way).

We also examine the role of L-Dopa and the deep brain stimulation on emotion perception

design_allocation: Non-Randomized

primary_purpose: Diagnostic


title: Food Habit Programming: Influence of Genetics and Early Nutrition in a Population of Preterm Infants

acronym: Polynuca

summary: Influence of neonatal nutrition and growth on psychomotor development of 2 years preterm infants.-Joint influence of environmental factor (early nutrition) and genetics factors on feeding behaviour setting- up in a particular population of infants of whom nutrition and life conditions during first weeks of life were purely controlled.

time_perspective: Prospective

ReferenceCitation: Migraine A, Nicklaus S, Parnet P, Lange C, Monnery-Patris S, Des Robert C, Darmaun D, Flamant C, Amarger V, Rozé JC. Effect of preterm birth and birth weight on eating behavior at 2 y of age. Am J Clin Nutr. 2013 Jun;97(6):1270-7. doi: 10.3945/ajcn.112.051151. Epub 2013 Apr 24.

family: Migraine

full_name: Audrey Migraine

given: Audrey

family: Nicklaus

full_name: Sophie Nicklaus

family: Parnet

full_name: Patricia Parnet

given: Patricia

family: Lange

full_name: Christine Lange

given: Christine

family: Monnery-Patris

full_name: Sandrine Monnery-Patris

given: Sandrine

family: Des Robert

full_name: Clotilde Des Robert

given: Clotilde

family: Darmaun

full_name: Dominique Darmaun

given: Dominique

family: Flamant

full_name: Cyril Flamant

given: Cyril

family: Amarger

full_name: Valerie Amarger

given: Valerie

family: Rozé

full_name: Jean-Christophe Rozé

given: Jean-Christophe

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The American Journal of Clinical Nutrition

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Nantes University Hospital

location_facility: Centre Hospitalier Universitaire de Nantes


title: Impact of Deep Brain Stimulation of Subthalamic Nucleus on the Hepatic Glucose Production in Parkinson's Disease

summary:
Parkinson' disease is a neurodegenerative disorder characterised by bradykinesia, rigidity, rest tremor and postural instability. Dopaminergic therapy such as L-Dopa and dopamine agonists usually leads to a dramatic improvement of symptoms, but disease progression nevertheless remains inevitable. Bilateral Deep brain stimulation in subthalamic nucleus (STN) leads to a spectacular clinical improvement in patients with motor complications and is now considered as the gold standard surgical treatment.

However, this surgery induces a post-operative body weight gain which may limit the benefits of this technique and induce critical metabolic disorders such as profound alterations in the central control of energy metabolism. Previous data seems to show that glucose metabolism is also altered.

The aim of this prospective study was to identify if the STN stimulation could modify glucose metabolism regulation especially the endogen glucose production (by liver) Hypothalamus is able to detect glucose concentration variations and to control/adjust glucose levels by modulating the hepatic glucose production. As hypothamus and STN are anatomically closed, we hypothesise that the STN stimulation could modulate the hypothalamus function and consequently modify glucose production.

ReferenceCitation: Batisse-Lignier M, Rieu I, Guillet C, Pujos E, Morio B, Lemaire JJ, Durif F, Boirie Y. Deep brain stimulation of the subthalamic nucleus regulates postabsorptive glucose metabolism in patients with Parkinson's disease. J Clin Endocrinol Metab. 2013 Jun;98(6):E1050-4. doi: 10.1210/jc.2012-3838. Epub 2013 Apr 30.

name: Unité de Nutrition Humaine (M.B.-L., C.G., E.P., B.M., Y.B.), BP 10448, Clermont Université, Université d'Auvergne, Institut National de la Recherche Agronomique Unité

name: Mixte de Recherche 1019 (M.B.L., C.G., E.P., B.M., Y.B.), UNH, Centre de Recherche en Nutrition Humaine Auvergne

family: Batisse-Lignier

full_name: Marie Batisse-Lignier

given: Marie

name: Department of Neurology (I.R., F.D.), Centre Hospitalier Universitaire Clermont-Ferrand

name: Neuro-Psycho-Pharmacologie des Systèmes Dopaminergiques Sous-Corticaux (I.R., F.D.), BP 10448, Clermont Université, Université d'Auvergne, EA 3845

family: Rieu

full_name: Isabelle Rieu

given: Isabelle

family: Guillet

full_name: Christelle Guillet

given: Christelle

family: Pujos

full_name: Estelle Pujos

given: Estelle

family: Morio

full_name: Béatrice Morio

given: Béatrice

name: Department of Neurosurgery (J.-J.L.), Centre Hospitalier Universitaire Clermont-Ferrand

family: Lemaire

full_name: Jean-Jacques Lemaire

given: Jean-Jacques

family: Durif

full_name: Franck Durif

given: Franck

name: Department of Clinical Nutrition (Y.B.), Centre Hospitalier Universitaire Clermont-Ferrand, Clermont-Ferrand, F-63003 France

family: Boirie

full_name: Yves Boirie

given: Yves

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

title: Deep Brain Stimulation of the Subthalamic Nucleus Regulates Postabsorptive Glucose Metabolism in Patients With Parkinson's Disease


summary: We hypothesize that anthocyans with calcium and vitamin D have a positive effect on bone reshaping in menopausal women.

primary_purpose: Prevention

lead_sponsor: Elvir SAS

intervention_type: Dietary Supplement

lead_sponsor_type: industriel


title: Effects of Rosuvastatin on the, in Vivo, Kinetic of VLDL apoB, IDL apoB, LDL apoB and HDL apoA1, Using Stable Isotopes, in Type 2 Diabetic Patients

summary:
Statins have been shown to reduce significantly the risk for cardiovascular events in patients with type 2 diabetes and statin therapy is largely recommended in this high cardiovascular risk population. However, a residual cardiovascular risk is observed in patients with type 2 diabetes treated by statins. This may be due to the fact that statins do not correct all lipid abnormalities associated with diabetic dyslipidaemia, such as hyperTG and low HDL-cholesterol.

Rosuvastatin is a statin which, in addition to its efficacy to reduce LDL-cholesterol, has been show to decrease significantly plasma triglycerides. However, the effects of rosuvastatin on triglyceride rich lipoproteins and HDL remains unknown. The purpose of this study is to analyze the effect rosuvastatin 20 mg on the metabolism of triglyceride rich lipoproteins and HDL in patients with Type 2 diabetes using and in vivo kinetic study of VLDL1-apoB,VLDL2-apoB,IDL-apoB and HDL-apoA1.

ReferenceCitation: Vergès B, Florentin E, Baillot-Rudoni S, Monier S, Petit JM, Rageot D, Gambert P, Duvillard L. Effects of 20 mg rosuvastatin on VLDL1-, VLDL2-, IDL- and LDL-ApoB kinetics in type 2 diabetes. Diabetologia. 2008 Aug;51(8):1382-90. doi: 10.1007/s00125-008-1046-4. Epub 2008 Jun 5.

family: Vergès

full_name: B. Vergès

given: B.

family: Florentin

full_name: E. Florentin

given: E.

family: Baillot-Rudoni

full_name: S. Baillot-Rudoni

given: S.

family: Monier

full_name: S. Monier

family: Petit

full_name: J. M. Petit

given: J. M.

family: Rageot

full_name: D. Rageot

given: D.

family: Gambert

full_name: P. Gambert

given: P.

family: Duvillard

full_name: L. Duvillard

given: L.

journal_name: Diabetologia

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Centre Hospitalier Universitaire de Dijon


title: Effect of an Interactive Computer Program to Prevent Alcohol Misuse. A Multicentre Randomized Controlled Trial. The BREVALCO Study.

acronym: BREVALCO

summary: The purpose of this study is to evaluate the effect of a brief computer program to prevent alcohol misuse for patients consulting in an emergency department and screened for alcohol misuse.

location_facility: Groupe hospitalier Bichat Claude Bernard


title: Usefulness of Measuring Plasma Brain Natriuretic Peptide for Diagnosis and Prognosis in Very Elderly Patients.

acronym: BED

summary: The purpose of this study is to test the usefulness of measuring plasma brain natriuretic peptide (BNP) for diagnosis and prognosis in very elderly dyspneic patients.

ReferenceType: background

ReferenceCitation: Komajda M, Hanon O, Aupetit JF, Benetos A, Berrut G, Emeriau JP, Friocourt P, Galinier M, De Groote P, Jondeau G, Jourdain P, Forette F. Management of heart failure in the elderly: recommendations from the French Society of Cardiology (SFC) and the French Society of Gerontology and Geriatrics (SFGG). J Nutr Health Aging. 2006 Sep-Oct;10(5):434-44. Review.


title: A Prospective Study of Coronary Artery Bypass Graft and/or Aortic Valve Replacement With Conventional Versus Half Heparin Dose Under Closed and Coated Extra Corporeal Circulation System (MECC) - APPACHES Study.

acronym: APPACHES

summary: The purpose of this study is to demonstrate superiority on postoperative bleeding from the use of a heparin half dose compared to a conventional dose, under mini-extra corporeal circulation, without increased risk to the patient.

lead_sponsor: University Hospital, Bordeaux

location_facility: Cardiac Surgery Dpt (University Hospital)


title: Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training

acronym: Biofeedback

summary: Looking for a modification of the cortical excitability of the motor area corresponding to the external anal sphincter after biofeedback sessions.

lead_sponsor: University Hospital, Rouen

location_facility: Physiology Unit - Rouen university Hospital

intervention_type: Other


title: A Multicenter Study to Assess Differences Between Circulating Levels of IGF-I and IGFBP-3 in Patients With Sporadic Late-onset Alzheimer's Disease and Control Elderly Subjects.

acronym: SIGAL

summary: The aim is to assess the relationship between levels of IGF-I system components and cognitive status in patients with Alzheimer's disease (AD), in elderly subjects with normal cognitive function, and in patients with mild cognitive impairment (MCI).

ReferenceCitation: Murialdo G, Barreca A, Nobili F, Rollero A, Timossi G, Gianelli MV, Copello F, Rodriguez G, Polleri A. Relationships between cortisol, dehydroepiandrosterone sulphate and insulin-like growth factor-I system in dementia. J Endocrinol Invest. 2001 Mar;24(3):139-46.

ReferenceCitation: Duron E, Funalot B, Brunel N, Coste J, Quinquis L, Viollet C, Belmin J, Jouanny P, Pasquier F, Treluyer JM, Epelbaum J, le Bouc Y, Hanon O. Insulin-like growth factor-I and insulin-like growth factor binding protein-3 in Alzheimer's disease. J Clin Endocrinol Metab. 2012 Dec;97(12):4673-81. doi: 10.1210/jc.2012-2063. Epub 2012 Sep 26.

name: Assistance Publique-Hôpitaux de Paris (AP-HP) (E.D., O.H.), Groupe Hospitalier Paris-Centre, Broca Hospital, Department of Geriatrics, 75013 Paris, France

name: University Paris Descartes (E.D., O.H.), Sorbonne Paris Cité, Equipe d'Accueil (EA) 4468, 75006 Paris, France

name: Centre de Psychiatrie et Neuroscience (E.D., B.F., C.V., J.E.), Institut National de la Santé et de la Recherche Médicale (INSERM), Unité Mixte de Recherche en Santé (UMRS) 894, 75014 Paris, France

family: Duron

full_name: Emmanuelle Duron

given: Emmanuelle

family: Funalot

full_name: Benoît Funalot

given: Benoît

name: Centre de Recherche St. Antoine (N.B., Y.L.B.), INSERM UMRS 938, Plateforme Institut Fédératif de Recherche 65, and INSERM, Bâtiment R. Kourilsky, Hôpital Saint-Antoine, 75571 Paris Cedex 12, France

family: Brunel

full_name: Nadège Brunel

given: Nadège

name: Unité d'Epidémiologie et de Biostatistique (J.C., L.Q.), Hôtel Dieu, 75181 Paris Cedex 4, France

family: Coste

full_name: Joel Coste

given: Joel

family: Quinquis

full_name: Laurent Quinquis

given: Laurent

family: Viollet

full_name: Cécile Viollet

given: Cécile

name: AP-HP (J.B.), Charles Foix Hospital, Department of Geriatrics, 94200 Ivry sur Seine, France

family: Belmin

full_name: Joel Belmin

name: Centre Hospitalo (P.J.), Universitaire d'Amiens, Department of Geriatrics, 80054 Salouël, Amiens Cedex1, France

family: Jouanny

full_name: Pierre Jouanny

given: Pierre

name: Université Lille-Nord de France (F.P.), EA 1046, Centre Hospitalier Régional Universitaire, Hôpital Roger Salengro, 59037 Lille France

family: Pasquier

full_name: Florence Pasquier

given: Florence

name: AP-HP (J.-M.T.), Groupe Hospitalier Paris Centre, Site Hôpital Tarnier, 75006 Paris, France

name: Unité de Recherche Clinique (J.-M.T.), Paris, France

family: Treluyer

full_name: Jean-Marc Treluyer

given: Jean-Marc

family: Epelbaum

full_name: Jacques Epelbaum

given: Jacques

family: le Bouc

full_name: Yves le Bouc

family: Hanon

full_name: Olivier Hanon

given: Olivier

title: Insulin-Like Growth Factor-I and Insulin-Like Growth Factor Binding Protein-3 in Alzheimer's Disease


title: Randomized Double-Blind Placebo Controlled Study Evaluating the Effect of Sublingual Administration of IFNa on the Immune Response to Influenza Vaccination in Subjects Aged 75 or More.

acronym: GP-INFA

summary: Influenza vaccination reduces the morbidity and mortality associated with influenza infection in at risk groups including the elderly and individuals with an impaired immune response, but is not totally protective in all recipient. Cytokines including type I interferons are known to play a key role in the innate immune response to virus infection and in the induction of the primary adaptive-immune response. Thus, we evaluated the safety of sublingual administration of IFNa and its effect on immune response to influenza vaccination in a randomized double-blind placebo controlled study in elderly institutionalized individuals.

location_facility: Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Broca-La Rochefoucauld, Service de Gérontologie 1


title: Evaluation of a New Treatment Strategy for Patients With Microscopic Polyangiitis, Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) Without Poor Prognosis Factors

summary: To determine whether a combination of corticosteroids and azathioprine can achieve a higher remission rate and a lower subsequent relapse rate in patients with newly-diagnosed microscopic polyangiitis, polyarteritis nodosa or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome) with no poor prognosis factor (FFS=0), and without significantly increasing the rate of adverse events, as compared to corticosteroids alone. The study hypothesis is a reduction of the absolute risk of treatment failure or relapse within the first 24 months following initiation of therapy of least 25%.

ReferenceCitation: Puéchal X, Pagnoux C, Baron G, Lifermann F, Geffray L, Quémeneur T, Saraux JL, Wislez M, Cottin V, Ruivard M, Limal N, Aouba A, Bonnotte B, Néel A, Agard C, Cohen P, Terrier B, Le Jeunne C, Mouthon L, Ravaud P, Guillevin L; French Vasculitis Study Group investigators. Non-severe eosinophilic granulomatosis with polyangiitis: long-term outcomes after remission-induction trial. Rheumatology (Oxford). 2019 Dec 1;58(12):2107-2116. doi: 10.1093/rheumatology/kez139.

name: National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, APHP, Université Paris Descartes, Paris, France

family: Puéchal

full_name: Xavier Puéchal

given: Xavier

name: Vasculitis Clinic, Mount Sinai Hospital, Toronto, Ontario, Canada

family: Pagnoux

full_name: Christian Pagnoux

given: Christian

name: Université Paris Descartes, Hôtel-Dieu, APHP, Paris, France

family: Baron

full_name: Gabriel Baron

given: Gabriel

name: Centre Hospitalier Côte d’Argent, Dax, France

family: Lifermann

full_name: François Lifermann

given: François

family: Geffray

full_name: Loïk Geffray

given: Loïk

name: Centre Hospitalier, Valenciennes, France

family: Quémeneur

full_name: Thomas Quémeneur

given: Thomas

name: Centre Hospitalier Simone-Veil, Eaubonne, France

family: Saraux

full_name: Jean-Luc Saraux

given: Jean-Luc

name: Hôpital Tenon, APHP, Université Pierre et Marie Curie, Paris, France

family: Wislez

full_name: Marie Wislez

given: Marie

name: Hôpital Louis-Pradel, Lyon and UMR754, Université Claude Bernard Lyon 1, Lyon, France

family: Cottin

full_name: Vincent Cottin

given: Vincent

name: Centre Hospitalier Universitaire Estaing, Clermont-Ferrand, France

family: Ruivard

full_name: Marc Ruivard

given: Marc

name: Hôpital Henri-Mondor, Université Paris-Est Créteil, APHP, Créteil, France

family: Limal

full_name: Nicolas Limal

given: Nicolas

name: Centre Hospitalier Universitaire Côte de Nacre, Caen, France

family: Aouba

full_name: Achille Aouba

given: Achille

name: Centre Hospitalier Universitaire du Bocage, Dijon, France

family: Bonnotte

full_name: Bernard Bonnotte

given: Bernard

name: Centre Hospitalier Universitaire Hôtel-Dieu, Nantes, France

family: Néel

full_name: Antoine Néel

given: Antoine

family: Agard

full_name: Christian Agard

family: Cohen

full_name: Pascal Cohen

given: Pascal

family: Terrier

full_name: Benjamin Terrier

given: Benjamin

family: Le Jeunne

full_name: Claire Le Jeunne

given: Claire

family: Mouthon

full_name: Luc Mouthon

given: Luc

family: Ravaud

full_name: Philippe Ravaud

given: Philippe

family: Guillevin

full_name: Loïc Guillevin

given: Loïc

family: Holy

full_name: Benahary Holy

given: Benahary

family: Florence

full_name: Gény Florence

given: Gény

family: Pascal

ReferenceCitation: Puéchal X, Pagnoux C, Baron G, Quémeneur T, Néel A, Agard C, Lifermann F, Liozon E, Ruivard M, Godmer P, Limal N, Mékinian A, Papo T, Ruppert AM, Bourgarit A, Bienvenu B, Geffray L, Saraux JL, Diot E, Crestani B, Delbrel X, Sailler L, Cohen P, Le Guern V, Terrier B, Groh M, Le Jeunne C, Mouthon L, Ravaud P, Guillevin L; French Vasculitis Study Group. Adding Azathioprine to Remission-Induction Glucocorticoids for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss), Microscopic Polyangiitis, or Polyarteritis Nodosa Without Poor Prognosis Factors: A Randomized, Controlled Trial. Arthritis Rheumatol. 2017 Nov;69(11):2175-2186. doi: 10.1002/art.40205. Epub 2017 Oct 15.

name: National Referral Center for Rare Systemic and Autoimmune Diseases, Department of Internal Medicine; Université Paris Descartes; Hôpital Cochin; AP-HP; Paris France

name: Université Paris Descartes; Hôtel-Dieu; AP-HP; Paris France

name: Centre Hospitalier Universitaire Hôtel-Dieu; Nantes France

name: Centre Hospitalier Côte d'Argent; Dax France

name: Centre Hospitalier Universitaire Dupuytren; Limoges France

name: Centre Hospitalier Universitaire Estaing; Clermont-Ferrand France

name: Centre Hospitalier Bretagne Atlantique; Vannes France

name: Hôpital Henri-Mondor; Université Paris-Est Créteil; AP-HP; Créteil France

name: Hôpital Saint-Antoine; Université Pierre et Marie Curie; AP-HP; Paris France

name: Hôpital Bichat-Claude-Bernard; Université Denis-Diderot; AP-HP; Paris France

name: Hôpital Tenon; Université Pierre et Marie Curie; AP-HP; Paris France

name: Hôpital Jean-Verdier; Université Léonard-de-Vinci; AP-HP; Bondy France

name: Centre Hospitalier Universitaire Côte de Nacre; Caen France

name: Centre Hospitalier Simone-Veil; Eaubonne France

name: Centre Hospitalier Universitaire; Tours France

name: Centre Hospitalier Universitaire Purpan; Toulouse France

location_facility: Hopital Cochin Pôle de Médecine UF Médecine Interne


title: Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer.

acronym: DOPMET

summary: Medullary thyroid carcinoma (MTC) is a rare tumor arising from C cells of the thyroid gland and belonging to the endocrine tumors. 18F-DOPA PET, based on tha capacity of endocrine tumor cells to take-up, decarboxylate and store amino-acids, such 3-4-dihydroxyphenylalanine(DOPA), is used for imaging endocrine tumors. The aim of the study was to evaluate the contribution of 18F-DOPA whole-body PET for the detection of recurrences in patients with proven recurrent MTC without evidence of recurrence or metastases on several imaging modalities.


title: Exhaled Markers of Oxidative Stress and Endothelium-dependent Vascular Relaxation in Obstructive Sleep Apnea. Effect of Continuous Positive Airway Pressure Therapy.

acronym: SOREVAS

summary: Patients with sleep apnea syndrome have repeated apneic events that induce periodic hypoxia-reoxygenation, drawing away an overproduction of oxidants. This exaggerated generation of oxidants is associated with a dysfunction of the vascular endothelium that evolves, in its turn, towards cardiovascular diseases such as systemic hypertension, stroke, and myocardial infarction. The major aim of our study is to examine the effect of CPAP treatment on biochemical (markers of oxidative stress) and functional (endothelium-dependent vascular relaxation reactivity) abnormalities at 1 and 4 weeks of treatment.

location_facility: Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

intervention_type: Device


title: International, Randomized, Controled, Double-Blind Study Assessing Efficacy of Kalinox® 170 Bar During the Realization of Invasive Gestures in Adult Oncology

summary: In the oncology practice, The National Union of the Centres of Fight Against the Cancer recently published the Standards, Options and Recommendations for the coverage of the pains provoked during the invasive gestures of a short duration realized at patients affected by cancer. These support the use of the Kalinox ® 170 bar as therapeutic alternative for the preparation of the painful procedures of a short duration such as spinal taps or osseous at the adult.The objective of this study thus is to clarify the appropriate efficiency and the tolerance of the equimolar mixture protoxide of nitrogen / oxygen during invasive procedures realized in adult oncology with regard to the analgesic reference methods and to the effect placebo leads by the accompaniment of the patient during the procedure.

lead_sponsor: Air Liquide Santé International


title: Cardiovascular Evaluation of a Rare Condition With Hyperaldosteronism Without Hypertension: PHA 1

acronym: PHACARV

summary: Vascular and cardiac alterations are associated with aldosterone effects are evidenced in experimental models and aldosterone receptor blockade is of clear benefit in cardiac disease (heart failure). The study aims at assessing vascular and cardiac alterations in adults with a chronic increase in circulating aldosterone without hypertension. The investigated population will be patients with a rare disease, pseudohypoaldosteronism type 1, due to heterozygous inactivating mutations of the mineralocorticoid receptor.

time_perspective: Cross-Sectional

ReferenceCitation: Pujo L, Fagart J, Gary F, Papadimitriou DT, Claës A, Jeunemaître X, Zennaro MC. Mineralocorticoid receptor mutations are the principal cause of renal type 1 pseudohypoaldosteronism. Hum Mutat. 2007 Jan;28(1):33-40.

ReferenceCitation: Sacré K, Brihaye B, Hyafil F, Serfaty JM, Escoubet B, Zennaro MC, Lidove O, Laissy JP, Papo T. Asymptomatic myocardial ischemic disease in antiphospholipid syndrome: a controlled cardiac magnetic resonance imaging study. Arthritis Rheum. 2010 Jul;62(7):2093-100. doi: 10.1002/art.27488.

ReferenceCitation: Escoubet B, Couffignal C, Laisy JP, Mangin L, Chillon S, Laouénan C, Serfaty JM, Jeunemaitre X, Mentré F, Zennaro MC. Cardiovascular effects of aldosterone: insight from adult carriers of mineralocorticoid receptor mutations. Circ Cardiovasc Genet. 2013 Aug;6(4):381-90. doi: 10.1161/CIRCGENETICS.113.000115. Epub 2013 Jul 14.

name: From the Assistance Publique-Hôpitaux de Paris, Hôpital Bichat-Claude Bernard, Paris, France (B.E., C.C., J.-P.L., L.M., S.C., C.L., J.-M.S., F.M.); Université Paris Diderot, Sorbonne Paris Cité (B.E., C.C., J.-P.L., L.M., C.L., J.-M.S., F.M.); Inserm, UMR 872, Centre de Recherche des Cordeliers CRC (B.E.); Inserm UMR-S 738 (C.C., C.L., F.M.); Laboratoire Matière et Systèmes Complexes, UMR-7057 CNRS (L.M.); Inserm, UMR 970 Paris Cardiovascular Research Centre (X.J., M.-C.Z.); Assistance Publique...

family: Escoubet

full_name: Brigitte Escoubet

given: Brigitte

family: Couffignal

full_name: Camille Couffignal

given: Camille

family: Laisy

full_name: Jean-Pierre Laisy

given: Jean-Pierre

family: Mangin

full_name: Laurence Mangin

given: Laurence

family: Chillon

full_name: Sylvie Chillon

given: Sylvie

family: Laouénan

full_name: Cédric Laouénan

given: Cédric

family: Serfaty

full_name: Jean-Michel Serfaty

given: Jean-Michel

family: Jeunemaitre

full_name: Xavier Jeunemaitre

given: Xavier

family: Mentré

full_name: France Mentré

given: France

family: Zennaro

full_name: Maria-Christina Zennaro

given: Maria-Christina

bso_classification: Biology (fond.)

journal_name: Circulation: Cardiovascular Genetics

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Cardiovascular Effects of Aldosterone


title: Therapeutic Efficacy Evaluation of the CPAP/autoCPAP Sandman in the Treatment of New Patients With Obstructive Sleep Apnoea Syndrome

summary:
The study is a prospective field evaluation to assess the therapeutic value of the CPAP/autoCPAP Sandman in 24 new diagnosed Obstructive Sleep Apneic patients.

Precisely, the study was designed to :

evaluate the therapeutic efficacy of the CPAP/autoCPAP Sandman device in improving sleep quality and normalozing respiratory events
determine the sensitivity and specificity of the device in adequately detecting respiratroy events
compare effective pressure Peff determined by the device and during manual titration
compare the impact of the two-speed descent pressure algorithm

status: Unknown status

lead_sponsor: Tyco Healthcare Group

location_facility: Hospital Michalon, sleep disorders center


title: A Phase I Open-label Dose-escalation Study of Intravenous Aflibercept (AVE0005, VEGF Trap) in Combination With R-CHOP Administered Every 2 Weeks or Every 3 Weeks in Patients With Non Hodgkin's B-cell Lymphoma

summary: The purpose of this study is to determine the selected dose of aflibercept when it is combined with R-CHOP treatment (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone +/- intrathecal Methotrexate) administered every 2 weeks or every 3 weeks, in non Hodgkin B-cell lymphoma, and to determine how the body handles aflibercept when it is administered with R-CHOP.

lead_sponsor: Sanofi


title: Validation of a Kalinox's Administration Protocol for Dental Cares : Interest of Re-oxygenation and Pollution Control

summary: The usefulness of re-oxygenation after inhalation of 50% nitrous oxide and 50% oxygen premix (Kalinox 170 bar) during dental care is studied and the pollution resulting from administration of Kalinox is also investigated.


title: Study of the Efficiency of Kalinox 170 Bar During Liver Biospy of Focal Lesion

summary: A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of liver biopsy in order to relax him and to reduce his pain during this painful medical treatment. This single investigator centre and national clinical trial is done blindly : half of patients will receive 50% nitrous oxide / 50% oxygen premix and half of them a placebo gas (mixture of 50% oxygen and 50% nitrogen). 94 patients will be included in this clinical protocol.


title: Effect on Hemodynamics of Automated Band Chest Compression Device in Cardiac Arrest Resuscitation

summary: To evaluate the effect of use of automated chest compression device on blood pressure in patients presenting with cardiac arrest. Higher systolic, diastolic and mean blood pressures are expected.

lead_sponsor: Beaujon Hospital

location_facility: Departement of Anesthesiology, Intensive Care and EMS, Beaujon University Hospital


title: Interest of Néfopam in the Treatment of Pain During the Intense Ureteral Calculi Uncomplicated in Adults in Emergencies Unit.

summary:
The administration of néfopam after initial treatment by kétoproféne, could obtain, in patients remaining pain and classically need morphine, analgesia at least the same as morphine alone. The use of néfopam second line after ketoprofen could reducing (or even eliminating) the need for morphine (and its side effects), allowing a reduction in the length of stay of patients in the emergency unit.

The main objective is to show that the addition of a néfopam initial treatment with the kétoproféne, reduces, in patients with ureteral calculi, the percentage of patients requiring the use of a treatment by morphine.

The secondary objective is to reduce the side effects caused by the morphine, shorten the time to install the appropriate level of analgesia while reducing the risk of failure of the titration morphine, reduce the time spent on titration of morphine and reduce the length of stay patient intake in emergency unit.

ReferenceCitation: Moustafa F, Liotier J, Mathevon T, Pic D, Perrier C, Schmidt J. Usefulness of nefopam in treating pain of severe uncomplicated renal colics in adults admitted to emergency units: a randomised double-blind controlled trial. The 'INCoNU' study. Emerg Med J. 2013 Feb;30(2):143-8. doi: 10.1136/emermed-2011-200753. Epub 2012 Mar 16.

family: Moustafa

full_name: Farès Moustafa

given: Farès

family: Liotier

full_name: Jérôme Liotier

given: Jérôme

family: Mathevon

full_name: Thierry Mathevon

given: Thierry

family: Pic

full_name: Daniel Pic

given: Daniel

family: Perrier

full_name: Christophe Perrier

given: Christophe

family: Schmidt

full_name: Jeannot Schmidt

given: Jeannot

journal_name: Emergency Medicine Journal

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Usefulness of nefopam in treating pain of severe uncomplicated renal colics in adults admitted to emergency units: a randomised double-blind controlled trial. The ‘INCoNU’ study


title: Effect of Controlled Diets on Structural and Functional Dynamic of the Human Intestinal Microflora

acronym: AlimIntest

summary: The main objective of the study is to realized a collection of feces in order to study the modification of the intestinal microflora according to alimentary fibres

primary_purpose: Basic Science

ReferenceCitation: Suau A, Bonnet R, Sutren M, Godon JJ, Gibson GR, Collins MD, Doré J. Direct analysis of genes encoding 16S rRNA from complex communities reveals many novel molecular species within the human gut. Appl Environ Microbiol. 1999 Nov;65(11):4799-807.

ReferenceCitation: Aaltonen LA, Peltomäki P, Leach FS, Sistonen P, Pylkkänen L, Mecklin JP, Järvinen H, Powell SM, Jen J, Hamilton SR, et al. Clues to the pathogenesis of familial colorectal cancer. Science. 1993 May 7;260(5109):812-6.

ReferenceCitation: Moore WE, Moore LH. Intestinal floras of populations that have a high risk of colon cancer. Appl Environ Microbiol. 1995 Sep;61(9):3202-7.

ReferenceCitation: Black AE, Coward WA, Cole TJ, Prentice AM. Human energy expenditure in affluent societies: an analysis of 574 doubly-labelled water measurements. Eur J Clin Nutr. 1996 Feb;50(2):72-92.

ReferenceCitation: Robinson RR, Feirtag J, Slavin JL. Effects of dietary arabinogalactan on gastrointestinal and blood parameters in healthy human subjects. J Am Coll Nutr. 2001 Aug;20(4):279-85.

ReferenceCitation: Tuohy KM, Kolida S, Lustenberger AM, Gibson GR. The prebiotic effects of biscuits containing partially hydrolysed guar gum and fructo-oligosaccharides--a human volunteer study. Br J Nutr. 2001 Sep;86(3):341-8.

ReferenceCitation: Chinda D, Nakaji S, Fukuda S, Sakamoto J, Shimoyama T, Nakamura T, Fujisawa T, Terada A, Sugawara K. The fermentation of different dietary fibers is associated with fecal clostridia levels in men. J Nutr. 2004 Aug;134(8):1881-6.

lead_sponsor: University Hospital, Grenoble


title: Effects of Subthalamic Nucleus Deep Brain Stimulation on Gastrointestinal Symptoms and Motility in Parkinson's Disease.

acronym: SCPDig

summary:
Patients with Parkinson's disease (PD) frequently experience upper gastrointestinal disorders. During the disease, weight loss is often noticed. Recently, many studies have demonstrated that STN-DBS improved extrapyramidal symptoms. Interestingly, PD patients gain weight after STN-DBS, at least in part due to a decrease in resting energy expenditure.

Purpose: To evaluate benefits of STN-DBS on upper gastrointestinal symptoms and motility.

Patients et method: PD patients waiting for STN-DBS, will be assessed in a preoperative time (2 times at, at least, 3 month intervals, to evaluate the natural history of the disease on upper gastrointestinal symptoms and motility) and in a postoperative time, after 6 months of chronic STN-DBS. Each assessment will include : 1/ questionnaires about frequency and severity of upper gastrointestinal symptoms; 2/ a nutritional assessment (body mass index, dietary assessment); 3/ the gastric emptying measurement with the 13C-octanoic acid breath test; 4/ the colorectal transit time measurement with radio-opaque markers 5/ an indirect calorimetry to estimate resting energy expenditure; 6/ and plasmatic leptin and ghrelin concentrations, hormones involved in the homeostatic regulation of appetite.

Perspectives: This physiopathological study should allow us to understand the mechanisms of the effects of STN-DBS on upper gastrointestinal symptoms and weight regulation in PD patients.


title: Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprains.

acronym: TALOS

summary: The aim of our study is to determine the most efficient radiologic examination to assess the ankle sprain seriousness and so improve the therapeutic care.

ReferenceCitation: Picard F, Tourné Y, Montbarbon E, Saragaglia D. [Ankle trauma. Diagnostic orientation]. Rev Prat. 1995 Nov 15;45(18):2335-42. French.

ReferenceCitation: Braun BL. Effects of ankle sprain in a general clinic population 6 to 18 months after medical evaluation. Arch Fam Med. 1999 Mar-Apr;8(2):143-8.

ReferenceCitation: Brasseur JL, Tardieu M. [Accurate use of imaging in ankle sprain]. JBR-BTR. 1999 Apr;82(2):63-8. Review. French.

ReferenceCitation: Raatikainen T, Putkonen M, Puranen J. Arthrography, clinical examination, and stress radiograph in the diagnosis of acute injury to the lateral ligaments of the ankle. Am J Sports Med. 1992 Jan-Feb;20(1):2-6.

ReferenceCitation: Brasseur JL, Morvan G, Godoc B. [Dynamic ultrasonography]. J Radiol. 2005 Dec;86(12 Pt 2):1904-10. Review. French.

ReferenceCitation: Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41.

location_facility: Emergency department - University Hospital of Grenoble South


title: Pharmacodynamic Evaluation of the ANTICALCIURIC Effect of Hydrochlorothiazide in Dent's Disease

acronym: DESY

summary: Intrarenal calcifications (nephrocalcinosis) is present in Dent's disease and likely contribute to progression toward renal failure. In order to prevent this complication it is usually proposed to treat affected patients during childhood with high doses of thiazides.

ReferenceCitation: Blanchard A, Vargas-Poussou R, Peyrard S, Mogenet A, Baudouin V, Boudailliez B, Charbit M, Deschesnes G, Ezzhair N, Loirat C, Macher MA, Niaudet P, Azizi M. Effect of hydrochlorothiazide on urinary calcium excretion in dent disease: an uncontrolled trial. Am J Kidney Dis. 2008 Dec;52(6):1084-95. doi: 10.1053/j.ajkd.2008.08.021. Epub 2008 Oct 30.

family: Blanchard

full_name: Anne Blanchard

given: Anne

family: Vargas-Poussou

full_name: Rosa Vargas-Poussou

given: Rosa

family: Peyrard

full_name: Severine Peyrard

given: Severine

family: Mogenet

full_name: Agnes Mogenet

given: Agnes

family: Baudouin

full_name: Veronique Baudouin

given: Veronique

family: Boudailliez

full_name: Bernard Boudailliez

given: Bernard

family: Charbit

full_name: Marina Charbit

given: Marina

family: Deschesnes

full_name: George Deschesnes

given: George

family: Ezzhair

full_name: Nadia Ezzhair

given: Nadia

family: Loirat

full_name: Chantal Loirat

given: Chantal

family: Macher

full_name: Marie-Alice Macher

given: Marie-Alice

family: Niaudet

full_name: Patrick Niaudet

given: Patrick

family: Azizi

full_name: Michel Azizi

given: Michel

journal_name: American Journal of Kidney Diseases

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Effect of Hydrochlorothiazide on Urinary Calcium Excretion in Dent Disease: An Uncontrolled Trial

location_facility: Centre d'investigation clinique HOPITAL GEORGE POMPIDOU


summary: Analyse the glucose profile, based on continuous glucose monitoring by CGMS, in type 2 diabetics inadequately controlled by metformin, before and after the addition of Glimepiride.


title: Randomized, Double-blind, Placebo-controlled Trial of Hydroxychloroquine in Primary Sjögren's Syndrome

acronym: JOQUER

summary:
Primary Sjögren's syndrome (SJp) affects 0.1% of the population. This systemic autoimmune disease systemic is characterized by disabling dryness, fatigue and pain, and systemic complications in 30% of patients. No treatment has proven effective in this disease. In open studies, some efficacy was observed with hydroxychloroquine but no RCT versus placebo has ever been done.

Thus, the primary purpose of this study is to evaluate the efficacy and safety of hydroxychloroquine (400mg/ day) on dryness, pain, and fatigue, assessed by the patient using visual analogical scales.

ReferenceCitation: Gottenberg JE, Ravaud P, Puéchal X, Le Guern V, Sibilia J, Goeb V, Larroche C, Dubost JJ, Rist S, Saraux A, Devauchelle-Pensec V, Morel J, Hayem G, Hatron P, Perdriger A, Sene D, Zarnitsky C, Batouche D, Furlan V, Benessiano J, Perrodeau E, Seror R, Mariette X. Effects of hydroxychloroquine on symptomatic improvement in primary Sjögren syndrome: the JOQUER randomized clinical trial. JAMA. 2014 Jul 16;312(3):249-58. doi: 10.1001/jama.2014.7682.

name: Department of Rheumatology, Service de Rhumatologie, Hôpitaux Universitaires de Strasbourg, Centre de Référence National Pour les Maladies Auto-Immunes Systémiques Rares, Université de Strasbourg, Strasbourg, France

family: Gottenberg

full_name: Jacques-Eric Gottenberg

given: Jacques-Eric

name: Department of Epidemiology and Public Health, Hotel Dieu, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France

family: Ravaud

full_name: Philippe Ravaud

given: Philippe

name: Department of Internal Medicine, Cochin Hospital, AP-HP, Paris, France

family: Puéchal

full_name: Xavier Puéchal

given: Xavier

family: Le Guern

full_name: Véronique Le Guern

given: Véronique

family: Sibilia

full_name: Jean Sibilia

given: Jean

name: Department of Rheumatology, Amiens University Hospital, Amiens, France

family: Goeb

full_name: Vincent Goeb

given: Vincent

name: Department of Internal Medicine, Avicenne Hospital, AP-HP, Bobigny, France

family: Larroche

full_name: Claire Larroche

given: Claire

name: Department of Rheumatology, Clermont-Ferrand University Hospital, Clermont-Ferrand, France

family: Dubost

full_name: Jean-Jacques Dubost

given: Jean-Jacques

name: Department of Rheumatology, Orléans Hospital, Orléans, France

family: Rist

full_name: Stéphanie Rist

given: Stéphanie

name: Department of Rheumatology, Brest University Hospital, Brest, France

family: Saraux

full_name: Alain Saraux

given: Alain

family: Devauchelle-Pensec

full_name: Valérie Devauchelle-Pensec

given: Valérie

name: Department of Rheumatology, Montpellier University Hospital, Montpellier, France

family: Morel

full_name: Jacques Morel

given: Jacques

name: Department of Rheumatology, Hôpital Bichat, AP-HP, Paris, France

family: Hayem

full_name: Gilles Hayem

given: Gilles

name: Department of Internal Medicine, Lille University Hospital, Lille, France

family: Hatron

full_name: Pierre Hatron

given: Pierre

name: Department of Rheumatology, Rennes University Hospital, Rennes, France

family: Perdriger

full_name: Aleth Perdriger

given: Aleth

name: Department of Internal Medicine, Lariboisère Hospital, AP-HP, Paris, France

family: Sene

full_name: Damien Sene

given: Damien

name: Department of Rheumatology, Le Havre Hospital, Le Havre, France

family: Zarnitsky

full_name: Charles Zarnitsky

given: Charles

name: Department of Rheumatology, Hôpitaux Universitaires Paris-Sud, AP-HP, INSERM U 1012, Université Paris Sud, Le Kremlin Bicêtre, France

family: Batouche

full_name: Djilali Batouche

given: Djilali

name: Department of Pharmacy, Hôpitaux Universitaires Paris-Sud, AP-HP, Le Kremlin Bicêtre, France

family: Furlan

full_name: Valérie Furlan

name: Department of Centre de Ressources Biologiques, Bichat Hospital, AP-HP, Paris, France

family: Benessiano

full_name: Joelle Benessiano

given: Joelle

family: Perrodeau

full_name: Elodie Perrodeau

given: Elodie

family: Seror

full_name: Raphaele Seror

given: Raphaele

family: Mariette

full_name: Xavier Mariette

title: Effects of Hydroxychloroquine on Symptomatic Improvement in Primary Sjögren Syndrome


type: Other Identifier

title: Constitution of a Population-based Cohort of Obese Subjects With Longitudinal Long-term Follow-up.

acronym: COLOMBES

summary: The objective of the project is the constitution of a population-based cohort of 500 persons with severe or morbid obesity (BMI over 35 kg/m2) with annual follow-up for 10 years. It aims to improve the physiopathological, epidemiological and prognostic knowledge of obesity and its consequences. Clinical data, biological material, exams and questionaires will be collected and stored, allowing the realisation of research works, initiated by research teams from our hospital or from other settings.


title: Neuroleptic and Huntington Disease. Comparison of : Olanzapine, la Tetrabenazine and Tiapride. A Multicentric, Randomised, Controlled Study.

acronym: NEUROHD

summary: Huntington's disease (HD) is autosomal dominant neurodegenerative disease, starting in average (with high variability) in the fourth decade. The disease progression is classically characterized by a cognitive deterioration (cortical-frontal dementia), motor disorders (associating chorea, dystonia and bradykinesia), psychiatric disturbances (combining depression and irritability) and metabolic disorder (cachexia). The disease is fatal within 15 to 20 years in most patients. HD has no cure. Neuroleptics are the main drug used and the only to demonstrate its efficacy on chorea in clinical trials. But neuroleptics have also beneficial and adverse effects on other disease characteristics (motor, psychiatric, cognitive or metabolic). Their profile between beneficial and adverse effects could be different according the neuroleptics and their classification. The aim of this study is to compare beneficial and adverse effects of 3 different neuroleptics in HD.

study_start_date_type: Actual


title: Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.

acronym: EPIC

summary: Anal incontinence is frequent and treatment is difficult. One of the most important reasons is traumatic delivery. 10 % of women develop anal incontinence after first delivery. This incidence is higher after second vaginal delivery, particularly if the first delivery caused break in the anal sphincter. One possibility to avoid anal incontinence is the caesarean section. So, do the investigators have to recommend caesarean section for second delivery if the first was traumatic? But caesarean section had a morbidity. Actually, the choice between the delivery modalities is very subjective.

ipd_sharing: Undecided

intervention_type: Procedure


title: Evaluation of the Efficacy of "MEOPA" Used to Obtain Better ROM Immediately After Multilevel Surgery in Children With Spastic Diplegia, Quadriplegia or Hemiplegia.

acronym: KINOPA

summary: Children with cerebral palsy commonly undergo "multilevel surgery", meaning several lower limb combined procedures performed during the same surgical intervention. The aim of this type of surgery is to correct all deformities together in order to restore near to normal anatomy and muscular function. It is very important to be able to obtain good range of motion after surgery, in order to consolidate surgical results. During the first days after the operation, children are sore and it may be difficult to realize adequate physical therapy. In order to palliate this situation, MEOPA gaz is used during REHAB sessions. Good results have been obtained so far but no study is available to demonstrate these results. The goal of our research is to prove that there is a benefit in using MEOPA postoperatively in these patients.

ReferenceCitation: Delafontaine A, Presedo A, Mohamed D, Lopes D, Wood C, Alberti C. Equimolar mixture of nitroux oxyde and oxygen during post-operative physiotherapy in patients with cerebral palsy: A randomized, double-blind, placebo-controlled study. Eur J Pain. 2017 Nov;21(10):1657-1667. doi: 10.1002/ejp.1071. Epub 2017 Jul 20.

name: AP-HP; Hôpital Robert Debré; Service de Chirurgie Orthopédique; Paris France

family: Delafontaine

full_name: A. Delafontaine

given: A.

family: Presedo

full_name: A. Presedo

name: AP-HP; Hôpital Robert-Debré; URC- UEC; Paris France

family: Mohamed

full_name: D. Mohamed

given: D.

family: Lopes

full_name: D. Lopes

name: Centre de la Douleur Chronique; CHU Dupuytren; Limoges France

family: Wood

full_name: C. Wood

given: C.

name: University Paris Diderot; Sorbonne Paris Cité; UMR-S1123; ECEVE; Paris France

name: INSERM; U1123 and CIC-1426; ECEVE; Paris France

family: Alberti

full_name: C. Alberti

journal_name: European Journal of Pain

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley


lead_sponsor: University Hospital, Limoges

source: euctr

title: Evaluation of the Efficacity of Lanreotide LP 90 mg to Minimized the Lymphorrhea Post Axillary Lymphadenectomy in Breast Cancer

summary: Injection the day before surgery of 90 mg of Lanreotide LP sub-cutaneously or placebo. Evaluation of the lymphorrhea in the 2 arms of the study


title: Etude du Polymorphysme génétique de la cholestérol 24S Hydroxylase et Des Teneurs en 24S hydroxycholestérol Chez Des Patients Atteints de Glaucome ou de dégénérescence Maculaire liée à l'âge.

summary: The aim of this study is to assess the implicitement of the cholesterol 24 S hydroxylase gene and the 24 S hydroxycholesterol in glaucoma and in age related macular degeneration.

primary_purpose: Screening

ReferenceCitation: Joffre C, Souchier M, Grégoire S, Viau S, Bretillon L, Acar N, Bron AM, Creuzot-Garcher C. Differences in meibomian fatty acid composition in patients with meibomian gland dysfunction and aqueous-deficient dry eye. Br J Ophthalmol. 2008 Jan;92(1):116-9.

intervention_type: Biological


title: Study to Analyze the Predictive Role of Factors Implicated in the Signaling Pathway of the EGFR in Response to Treatment With Neoadjuvant Chemoradiotherapy in Patients With Cancer of the Esophagus or Rectum

summary:
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying how well biological factors work in predicting response to treatment in patients with esophageal cancer or rectal cancer.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle


title: Randomized Strategy Trial Comparing Detection of Silent Ischemia With no Detection of Silent Ischemia in Asymptomatic Patients With Type 2 Diabetes Mellitus. Effects on Cardiovascular Events.

acronym: DYNAMIT

summary: DYNAMIT is a prospective, randomized, multicenter, open strategy trial run in 45 French hospitals. Diabetic patients with no evidence of coronary artery disease and at least 2 additional cardiovascular risk factors are randomized to screening for silent ischemia using a bicycle exercise test or Dipyridamole Single Photon Emission Computed Tomography (N=316), or follow-up without screening (N=315). All have access to cardiovascular prevention according current guidelines. The main end point is time to death from all causes, non-fatal myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or emergency service intervention.

ReferenceCitation: Lièvre MM, Moulin P, Thivolet C, Rodier M, Rigalleau V, Penfornis A, Pradignac A, Ovize M; DYNAMIT investigators. Detection of silent myocardial ischemia in asymptomatic patients with diabetes: results of a randomized trial and meta-analysis assessing the effectiveness of systematic screening. Trials. 2011 Jan 26;12:23. doi: 10.1186/1745-6215-12-23.

family: Lièvre

full_name: Michel M Lièvre

given: Michel M

family: Moulin

full_name: Philippe Moulin

given: Philippe

family: Thivolet

full_name: Charles Thivolet

family: Rodier

full_name: Michel Rodier

given: Michel

family: Rigalleau

full_name: Vincent Rigalleau

given: Vincent

family: Penfornis

full_name: Alfred Penfornis

given: Alfred

family: Pradignac

full_name: Alain Pradignac

family: Ovize

full_name: Michel Ovize

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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)

lead_sponsor: Hospices Civils de Lyon


title: Phase 2 Randomized Study Evaluating the Efficacy of Gemcitabine With or Without Oxaliplatin in Patients With Advanced Urothelial Cancer That Cannot be Treated With Cisplatin-based Chemotherapy

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving gemcitabine together with oxaliplatin works compared to gemcitabine alone in treating patients with locally advanced or metastatic bladder cancer.


title: Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, etoposide, and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which drug is more effective in killing tumor cells.

PURPOSE: This randomized phase II trial is studying how well mitoxantrone works compared to etoposide or vinorelbine works as second-line therapy in treating patients with metastatic prostate cancer that did not respond to hormone therapy.

lead_sponsor: Groupe D'Etude des Tumeurs Uro-Genitales


title: recipientsProspective Evaluation of the Efficacy of Budesonide/Formoterol (Symbicort®) in Bronchiolitis Obliterans in Allogeneic Haematopoietic Stem Cell Transplantation (AHSCT) Recipients

acronym: Alloforb

summary: The usual treatment for obstructive airway disease (OAD) after allogeneic hematopoietic stem cell transplantation (AHSCT) , which is related to graft versus host disease (GVHD), consists of intensification of systemic immunosuppressive therapy.

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

ReferenceCitation: Bergeron A, Chevret S, Chagnon K, Godet C, Bergot E, Peffault de Latour R, Dominique S, de Revel T, Juvin K, Maillard N, Reman O, Contentin N, Robin M, Buzyn A, Socié G, Tazi A. Budesonide/Formoterol for bronchiolitis obliterans after hematopoietic stem cell transplantation. Am J Respir Crit Care Med. 2015 Jun 1;191(11):1242-9. doi: 10.1164/rccm.201410-1818OC.

family: Bergeron

full_name: Anne Bergeron

given: Anne

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Chagnon

full_name: Karine Chagnon

given: Karine

family: Godet

full_name: Cendrine Godet

given: Cendrine

family: Bergot

full_name: Emmanuel Bergot

given: Emmanuel

family: Peffault de Latour

full_name: Régis Peffault de Latour

given: Régis

family: Dominique

full_name: Stéphane Dominique

given: Stéphane

family: de Revel

full_name: Thierry de Revel

given: Thierry

family: Juvin

full_name: Karine Juvin

family: Maillard

full_name: Natacha Maillard

given: Natacha

family: Reman

full_name: Oumedaly Reman

given: Oumedaly

family: Contentin

full_name: Nathalie Contentin

given: Nathalie

family: Robin

full_name: Marie Robin

given: Marie

family: Buzyn

full_name: Agnès Buzyn

given: Agnès

family: Socié

full_name: Gérard Socié

given: Gérard

family: Tazi

full_name: Abdellatif Tazi

given: Abdellatif

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

title: Budesonide/Formoterol for Bronchiolitis Obliterans after Hematopoietic Stem Cell Transplantation


title: LMA ProSeal & I-Gel : a Prospective Controlled Trial

acronym: I-Gel

summary: The i-gel is a new supra glottic airway device with a non inflatable cuff and an oesophageal vent. The aim of this study is to compare this device to the LMA ProSeal. The study is approved by the institutional ethic committee. 222 patients will be enrolled in each group. The objectives of the study will be to compare insertion success rate, leak pressure, ventilatory parameters and adverse event rate.

ReferenceCitation: Cros AM. [New laryngeal mask airway: easy and evolution to an better safety]. Ann Fr Anesth Reanim. 2006 Aug;25(8):804-5. Epub 2006 Jul 20. French.

ReferenceCitation: Asai T. Editorial II: Who is at increased risk of pulmonary aspiration? Br J Anaesth. 2004 Oct;93(4):497-500.

ReferenceCitation: Cook TM, Lee G, Nolan JP. The ProSeal laryngeal mask airway: a review of the literature. Can J Anaesth. 2005 Aug-Sep;52(7):739-60. Review.

ReferenceCitation: Keller C, Brimacombe J, Kleinsasser A, Loeckinger A. Does the ProSeal laryngeal mask airway prevent aspiration of regurgitated fluid? Anesth Analg. 2000 Oct;91(4):1017-20.

ReferenceCitation: Brimacombe J, Richardson C, Keller C, Donald S. Mechanical closure of the vocal cords with the laryngeal mask airway ProSeal. Br J Anaesth. 2002 Feb;88(2):296-7.

ReferenceCitation: Levitan RM, Kinkle WC. Initial anatomic investigations of the I-gel airway: a novel supraglottic airway without inflatable cuff. Anaesthesia. 2005 Oct;60(10):1022-6.

ReferenceCitation: Cook TM, McKinstry C, Hardy R, Twigg S. Randomized crossover comparison of the ProSeal laryngeal mask airway with the Laryngeal Tube during anaesthesia with controlled ventilation. Br J Anaesth. 2003 Nov;91(5):678-83.

ReferenceCitation: Cook TM, Nolan JP, Verghese C, Strube PJ, Lees M, Millar JM, Baskett PJ. Randomized crossover comparison of the proseal with the classic laryngeal mask airway in unparalysed anaesthetized patients. Br J Anaesth. 2002 Apr;88(4):527-33.


title: Impact of PET Scan on the Curative Strategy of Colo-rectal Cancers : A Randomized Study

acronym: ITEP

summary: The risk of recurrence in stage III and IV of colorectal cancers (CRC) is high during the three years following the tumoral resection with curative aim. Therefore, a prolonged follow-up and an intense monitoring are recommended to detect these recurrences precociously. Nevertheless, current consensual morphological and biological examinations are not very contributory, of difficult interpretation and expensive. The metabolic imagery in tomoscintigraphy by emission of positron coupled with the scanner, called PET-TDM, allows to identify more specifically recurrences, analyzes the whole body, detects hepatic metastasis more precociously and give some benefice for early diagnosis of lymph nodes recurrence. The principle purpose of this study is to evaluate if the systematic follow-up per PET-TDM allows detecting more often recurrences accessible to a curative surgery. We make the hypothesis that the systematic practice of PET- tomodensitometry (TDM) during the follow-up of CRC allows to decrease non curative recurrences appearance during the 3 years follow-up after a curative surgery.

ReferenceCitation: Sobhani I, Itti E, Luciani A, Baumgaertner I, Layese R, André T, Ducreux M, Gornet JM, Goujon G, Aparicio T, Taieb J, Bachet JB, Hemery F, Retbi A, Mons M, Flicoteaux R, Rhein B, Baron S, Cherrak I, Rufat P, Le Corvoisier P, de'Angelis N, Natella PA, Maoulida H, Tournigand C, Durand Zaleski I, Bastuji-Garin S. Colorectal cancer (CRC) monitoring by 6-monthly 18FDG-PET/CT: an open-label multicentre randomised trial. Ann Oncol. 2018 Apr 1;29(4):931-937. doi: 10.1093/annonc/mdy031.

family: Sobhani

full_name: I. Sobhani

given: I.

family: Itti

full_name: E. Itti

given: E.

family: Luciani

full_name: A. Luciani

given: A.

family: Baumgaertner

full_name: I. Baumgaertner

family: Layese

full_name: R. Layese

given: R.

family: André

full_name: T. André

given: T.

family: Ducreux

full_name: M. Ducreux

given: M.

family: Gornet

full_name: J.-M. Gornet

family: Goujon

full_name: G. Goujon

given: G.

family: Aparicio

full_name: T. Aparicio

family: Taieb

full_name: J. Taieb

given: J.

family: Bachet

full_name: J.-B. Bachet

family: Hemery

full_name: F. Hemery

given: F.

family: Retbi

full_name: A. Retbi

family: Mons

full_name: M. Mons

family: Flicoteaux

full_name: R. Flicoteaux

family: Rhein

full_name: B. Rhein

given: B.

family: Baron

full_name: S. Baron

given: S.

family: Cherrak

full_name: I. Cherrak

family: Rufat

full_name: P. Rufat

given: P.

family: Le Corvoisier

full_name: P. Le Corvoisier

family: de’Angelis

full_name: N. de’Angelis

given: N.

family: Natella

full_name: P.-A. Natella

family: Maoulida

full_name: H. Maoulida

given: H.


ReferenceCitation: Baud O. [Postnatal steroid treatment in preterm infants: risk/benefit ratio]. J Gynecol Obstet Biol Reprod (Paris). 2005 Feb;34(1 Suppl):S118-26. Review. French.

ReferenceCitation: Baud O, Maury L, Lebail F, Ramful D, El Moussawi F, Nicaise C, Zupan-Simunek V, Coursol A, Beuchée A, Bolot P, Andrini P, Mohamed D, Alberti C; PREMILOC trial study group. Effect of early low-dose hydrocortisone on survival without bronchopulmonary dysplasia in extremely preterm infants (PREMILOC): a double-blind, placebo-controlled, multicentre, randomised trial. Lancet. 2016 Apr 30;387(10030):1827-36. doi: 10.1016/S0140-6736(16)00202-6. Epub 2016 Feb 23.

family: Baud

full_name: Olivier Baud

given: Olivier

family: Maury

full_name: Laure Maury

given: Laure

family: Lebail

full_name: Florence Lebail

given: Florence

family: Ramful

full_name: Duksha Ramful

given: Duksha

family: El Moussawi

full_name: Fatima El Moussawi

given: Fatima

family: Nicaise

full_name: Claire Nicaise

given: Claire

family: Zupan-Simunek

full_name: Véronique Zupan-Simunek

given: Véronique

family: Coursol

full_name: Anne Coursol

given: Anne

family: Beuchée

full_name: Alain Beuchée

given: Alain

family: Bolot

full_name: Pascal Bolot

given: Pascal

family: Andrini

full_name: Pierre Andrini

given: Pierre

family: Mohamed

full_name: Damir Mohamed

given: Damir

family: Alberti

full_name: Corinne Alberti

given: Corinne

journal_name: The Lancet

ReferenceCitation: Baud O, Trousson C, Biran V, Leroy E, Mohamed D, Alberti C; PREMILOC Trial Group. Association Between Early Low-Dose Hydrocortisone Therapy in Extremely Preterm Neonates and Neurodevelopmental Outcomes at 2 Years of Age. JAMA. 2017 Apr 4;317(13):1329-1337. doi: 10.1001/jama.2017.2692.

name: Neonatal Intensive Care Unit, Assistance Publique-Hôpitaux de Paris, Robert Debré Children’s Hospital, Paris, France2Université Paris Diderot, Sorbonne Paris-Cité, Inserm U1141, Paris, France

family: Trousson

full_name: Clémence Trousson

given: Clémence

family: Biran

full_name: Valérie Biran

given: Valérie

family: Leroy

full_name: Emilie Leroy

given: Emilie

name: Unit of Clinical Epidemiology, Assistance Publique-Hôpitaux de Paris, Robert Debré Children’s Hospital, University Paris Diderot, Sorbonne Paris-Cité, Inserm U1123 and CIC-EC 1426, Paris, France

journal_name: JAMA

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Baud O, Alberti C, Mohamed D, Watterberg K. Low-dose hydrocortisone in extremely preterm infants - Authors' reply. Lancet. 2016 Sep 17;388(10050):1158-9. doi: 10.1016/S0140-6736(16)31611-7. Epub 2016 Sep 16.

title: Low-dose hydrocortisone in extremely preterm infants – Authors' reply

ReferenceCitation: Renolleau C, Toumazi A, Bourmaud A, Benoist JF, Chevenne D, Mohamed D, Alberti C, Biran V, Baud O; PREMILOC Trial Study Group. Association between Baseline Cortisol Serum Concentrations and the Effect of Prophylactic Hydrocortisone in Extremely Preterm Infants. J Pediatr. 2021 Jul;234:65-70.e3. doi: 10.1016/j.jpeds.2020.12.057. Epub 2020 Dec 24.

repository_institution: University of Geneva - Archive ouverte UNIGE

ReferenceCitation: Alison M, Tilea B, Toumazi A, Biran V, Mohamed D, Alberti C, Bourmaud A, Baud O; PREMILOC Trial group. Prophylactic hydrocortisone in extremely preterm infants and brain MRI abnormality. Arch Dis Child Fetal Neonatal Ed. 2020 Sep;105(5):520-525. doi: 10.1136/archdischild-2019-317720. Epub 2020 Jan 24.

journal_name: Archives of Disease in Childhood - Fetal and Neonatal Edition

ReferenceCitation: Héneau A, Guimiot F, Mohamed D, Rideau Batista Novais A, Alberti C, Baud O; PREMILOC Trial study group. Placental Findings and Effect of Prophylactic Hydrocortisone in Extremely Preterm Infants. Pediatrics. 2018 Feb;141(2). pii: e20171788. doi: 10.1542/peds.2017-1788. Epub 2018 Jan 18.

title: Early Prevention of Broncho-pulmonary Dysplasia and Neonatal Mortality in Very Preterm Infants Using Low Dose of Hydrocortisone: a Randomized Controlled Trial

summary: There is increasing evidence linking a fetal and early neonatal systemic inflammatory response syndrome to the subsequent development of bronchopulmonary dysplasia (BPD) and white matter injury (WMI) in very preterm infants. Babies with evidence of adrenal insufficiency early in life may not be able to control the inflammatory response and are thereby more likely to develop BPD than babies who do not show such evidence of inflammation. We designed a randomized controlled trial to test the hypothesis whether very preterm babies at high-risk of BPD, treated with low doses of HC during the first 10 days of life, are more likely to survive without BPD at 36 weeks of post-menstrual age (PMA), compared to babies treated with placebo.


title: Left Ventricular Function Assessment After Acute Myocardial Infarction: Comparison Between bi-, Three-dimensional and Cardiac Magnetic Resonance

summary: compare measurements of left ventricular volumes and LVEF obtained by 2DE, 3DE, and CMR after a ST elevation myocardial infarction (STEMI) complicated by systolic left ventricular dysfunction

primary_purpose: Supportive Care

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE 10-26)

acronym: EXTRA

summary: This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm^2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting

lead_sponsor: Novartis


title: A Phase I, Pharmacokinetic and Tolerability Study of Intravenous Unfractionated Heparin After Subcutaneous Enoxaparin 1mg/kg Bid Repeated Administration in Healthy Subjects

summary:
Primary objective:

to characterize the pharmacokinetic and the pharmacodynamic profile after intravenous bolus injection of unfractionated heparin (UFH) after repeated sc 100 IU anti-Xa/kg (corresponding to 1 mg/kg) twice a day during 2.5 days (every 12±2hrs) administrations of enoxaparin in Caucasian healthy subjects.

Secondary objective(s):

to compare the pharmacokinetic and the pharmacodynamic profile between 3 different timing of administration of the UFH
to assess the tolerability of the different anticoagulation protocols

ReferenceCitation: Drouet L, Bal dit Sollier C, Martin J. Adding intravenous unfractionated heparin to standard enoxaparin causes excessive anticoagulation not detected by activated clotting time: results of the STACK-on to ENOXaparin (STACKENOX) study. Am Heart J. 2009 Aug;158(2):177-84. doi: 10.1016/j.ahj.2009.05.022.


title: Levobupivacïne Into Post-analgesia : Randomized Monocentric Study Against Placebo

acronym: LEVOBU

summary:
The locoregional anaesthesia is increasingly important in surgical practice, often allowing to simplify per- and post-operative analgesia. caesarian occurs in 20 % of delivery leading to a longer hospitalization because of the pain resulting from the surgery. The Levobupivacaïne (Chirocaïne) administered through catheters placed in the caesarean scars, showed its efficiency in post-operative analgesia.

Method : realization of a double blind prospective randomized study, control versus placebo Purpose : to show that the local administration of a unique dose of analgesia reduce the post-operative pain with a little or non-invasive technique

ReferenceCitation: Corsini T, Cuvillon P, Forgeot A, Chapelle C, Seffert P, Chauleur C. [Single-dose intraincisional levobupivacaine infiltration in caesarean postoperative analgesia: a placebo-controlled double-blind randomized trial]. Ann Fr Anesth Reanim. 2013 Jan;32(1):25-30. doi: 10.1016/j.annfar.2012.10.035. Epub 2012 Dec 21. French.

family: Corsini

full_name: T. Corsini

given: T.

family: Cuvillon

full_name: P. Cuvillon

given: P.

family: Forgeot

full_name: A. Forgeot

given: A.

family: Chapelle

full_name: C. Chapelle

given: C.

family: Seffert

full_name: P. Seffert

family: Chauleur

full_name: C. Chauleur

journal_name: Annales Françaises d'Anesthésie et de Réanimation

title: Infiltration peropératoire de lévobupivacaïne après césariennes : étude randomisée en double insu contre placebo

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne