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: Garcia R, Marijon E, Karam N, Narayanan K, Anselme F, Cesari O, Champ-Rigot L, Manenti V, Martins R, Puymirat E, Ferrieres J, Schiele F, Simon T, Danchin N. Ventricular fibrillation in acute myocardial infarction: 20-year trends in the FAST-MI study. Eur Heart J. 2022 Oct 28:ehac579. doi: 10.1093/eurheartj/ehac579. Online ahead of print.

ReferenceCitation: Dillinger JG, Achkouty G, Albert F, Muller G, Labèque JN, Moisson L, Morelle JF, Cottin Y, Pezel T, Lim P, Aissaoui N, Schiele F, Ferrières J, Angoulvant D, Henry P, Puymirat E, Simon T, Danchin N; FAST-MI investigators. Deleterious synergistic effects of acute heart failure and diabetes mellitus in patients with acute coronary syndrome: Data from the FAST-MI Registries. Arch Cardiovasc Dis. 2022 May;115(5):264-275. doi: 10.1016/j.acvd.2022.02.004. Epub 2022 Mar 4.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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: 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


type: EudraCT Number

title: An Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics of the CYP2D6 Substrate Desipramine in Healthy Subjects

summary: The study aims to evaluate if blood levels of desipramine change whilst being dosed at the same time with daily mirabegron.

status: Completed

ReferenceType: background

ReferenceCitation: Krauwinkel W, Dickinson J, Schaddelee M, Meijer J, Tretter R, van de Wetering J, Strabach G, van Gelderen M. The effect of mirabegron, a potent and selective β3-adrenoceptor agonist, on the pharmacokinetics of CYP2D6 substrates desipramine and metoprolol. Eur J Drug Metab Pharmacokinet. 2014 Mar;39(1):43-52. doi: 10.1007/s13318-013-0133-1. Epub 2013 Jun 1.

lead_sponsor: Astellas Pharma Inc

lead_sponsor_type: industriel

status_simplified: Completed


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.

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.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Personalized Haemodynamic Management of Septic Shock: Influence of Mean Arterial Pressure Level on Renal Function: Randomized Controlled Trial

acronym: DORESEP

summary: Sepsis is the most severe complication of infections. Sepsis-associated Acute kidney injury (AKI) is commonly encountered in critically ill patients and independently predicts poor outcome. Unfortunately, no drug or management strategy was able to reduce incidence of AKI. To adapt the level of mean arterial pressure according to local renal hemodynamic evaluated by renal Doppler could lead to a better renal perfusion, and then less AKI.

location_facility: Reanimation Chirurgicale - Hôpital Kremlin Bicêtre

intervention_type: Other


type: Other Identifier

title: Randomized Control Study : Safety and Efficacy of Carbohydrate Drink Ingested Two Hours Before Upper Endoscopy Under General Anaesthesia

acronym: ENDOGLUcide

summary: In several national anaesthesia societies, clear fluids are allowed up to 2 hours before general anaesthesia (GA) and light meals up to 6h. Because of aspiration risk, strict fasting remains routine. Recently, surgical studies proved that pre-operative carbohydrate-rich drink reduces preoperative discomfort without affecting gastric fluid volume and acidity.The aim of this study was to show the effects of preanaesthetic oral fluid in patients undergoing upper endoscopy without emergency. The expected efficacy is a reduction of the preoperative discomfort. The investigators thus propose a randomised prospective open-label study to assess efficacy of preanaesthetic oral glucose drink in patients undergoing upper endoscopy without emergency. Study compare two groups : group "drink" (200 ml of fruit juice without pulp ± 200 ml of coffee or tea, 2 at 4 hours before the induction of anaesthesia) and group "overnight fasting".Discomfort was measured at 2 hours before GA (H-2), just before GA (H0) and 4h after anaesthesia (H+4). Each item (anxiety, thirst, hunger, nervousness, tiredness, nausea) was estimated by visual analogue scale (VAS from 0 to 100mm) and handgrip strength by dynamometer. Gastroenterologist assessed the quality of endoscopy (VAS), gastric residual fluid and acidity.The main aim of this study was to assess in patients referred for upper endoscopy under general anaesthesia, the effect of carbohydrate drink on preanaesthetic discomfort. Secondary purpose were to compare quality of endoscopy, residual gastric volumes, gastric acidity and incidence of side effects. 118 patients will be included in the study. A stratification will be made on the type of endoscopy.

lead_sponsor: University Hospital, Caen

intervention_type: Procedure


title: Epidural Analgesia vs. Morphine Patient-controlled Analgesia in Abdominal Surgery Under Laparotomy : a Medico-economic Study

acronym: PERIDIGE

summary:
Background : Epidural anaesthesia is associated in abdominal surgery with reduced pain and postoperative respiratory complications together with quicker recovery of bowel function. Currently, no studies have been able to prove its ability to reduce length of stay in intensive care and high-dependency units.

Purpose : The aim of this study is to demonstrate that epidural anaesthesia reduces length of stay in intensive care unit after abdominal surgery under laparotomy.

lead_sponsor: University Hospital, Limoges

location_facility: CHU de Limoges - Service d'anesthésie-réanimation


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.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

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.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral


title: Identification of Biomarkers in Patients With Autosomal Dominant Cerebellar Ataxia

acronym: BIOSCA

summary: Autosomal dominant cerebellar ataxias (ADCA) are a group of neurodegenerative disorders that are clinically and genetically various. BIOSCA study aims to identify markers of the metabolism (energy production inside the cells) in the blood and the brain of ADCA 1,2,3 and 7 patients and control subjects, in the perspective of future therapeutic trials.

time_perspective: Prospective

ReferenceCitation: Adanyeguh IM, Henry PG, Nguyen TM, Rinaldi D, Jauffret C, Valabregue R, Emir UE, Deelchand DK, Brice A, Eberly LE, Öz G, Durr A, Mochel F. In vivo neurometabolic profiling in patients with spinocerebellar ataxia types 1, 2, 3, and 7. Mov Disord. 2015 Apr 15;30(5):662-70. doi: 10.1002/mds.26181. Epub 2015 Mar 15.

ReferenceCitation: Adanyeguh IM, Perlbarg V, Henry PG, Rinaldi D, Petit E, Valabregue R, Brice A, Durr A, Mochel F. Autosomal dominant cerebellar ataxias: Imaging biomarkers with high effect sizes. Neuroimage Clin. 2018 Jun 14;19:858-867. doi: 10.1016/j.nicl.2018.06.011. eCollection 2018.

ReferenceCitation: Garali I, Adanyeguh IM, Ichou F, Perlbarg V, Seyer A, Colsch B, Moszer I, Guillemot V, Durr A, Mochel F, Tenenhaus A. A strategy for multimodal data integration: application to biomarkers identification in spinocerebellar ataxia. Brief Bioinform. 2018 Nov 27;19(6):1356-1369. doi: 10.1093/bib/bbx060.

ReferenceCitation: Faber J, Schaprian T, Berkan K, Reetz K, França MC Jr, de Rezende TJR, Hong J, Liao W, van de Warrenburg B, van Gaalen J, Durr A, Mochel F, Giunti P, Garcia-Moreno H, Schoels L, Hengel H, Synofzik M, Bender B, Oz G, Joers J, de Vries JJ, Kang JS, Timmann-Braun D, Jacobi H, Infante J, Joules R, Romanzetti S, Diedrichsen J, Schmid M, Wolz R, Klockgether T. Regional Brain and Spinal Cord Volume Loss in Spinocerebellar Ataxia Type 3. Mov Disord. 2021 Oct;36(10):2273-2281. doi: 10.1002/mds.28610. Epub 2021 May 5.

ReferenceCitation: Coarelli G, Darios F, Petit E, Dorgham K, Adanyeguh I, Petit E, Brice A, Mochel F, Durr A. Plasma neurofilament light chain predicts cerebellar atrophy and clinical progression in spinocerebellar ataxia. Neurobiol Dis. 2021 Jun;153:105311. doi: 10.1016/j.nbd.2021.105311. Epub 2021 Feb 23.


title: Extracorporeal Membrane Oxygenation(ECMO) for Severe Acute Respiratory Distress Syndrome (ARDS)

acronym: EOLIA

summary: This international multicenter, randomized, open trial will evaluate the impact of Extracorporeal Membrane Oxygenation (ECMO), instituted early after the diagnosis of acute respiratory distress syndrome (ARDS) not evolving favorably after 3-6 hours under optimal ventilatory management and maximum medical treatment, on the morbidity and mortality associated with this disease.

study_start_date_type: Actual

ReferenceCitation: Combes A, Hajage D, Capellier G, Demoule A, Lavoué S, Guervilly C, Da Silva D, Zafrani L, Tirot P, Veber B, Maury E, Levy B, Cohen Y, Richard C, Kalfon P, Bouadma L, Mehdaoui H, Beduneau G, Lebreton G, Brochard L, Ferguson ND, Fan E, Slutsky AS, Brodie D, Mercat A; EOLIA Trial Group, REVA, and ECMONet. Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome. N Engl J Med. 2018 May 24;378(21):1965-1975. doi: 10.1056/NEJMoa1800385.

ReferenceCitation: Schmidt M, Combes A. Influence of ventilatory strategy on the PRESERVE mortality risk score: response to Camporota et al. Intensive Care Med. 2014 Jun;40(6):916. doi: 10.1007/s00134-014-3284-x. Epub 2014 Apr 10.

ReferenceCitation: Schmidt M, Pellegrino V, Combes A, Scheinkestel C, Cooper DJ, Hodgson C. Mechanical ventilation during extracorporeal membrane oxygenation. Crit Care. 2014 Jan 21;18(1):203. doi: 10.1186/cc13702. Review.

ReferenceCitation: Schmidt M, Zogheib E, Rozé H, Repesse X, Lebreton G, Luyt CE, Trouillet JL, Bréchot N, Nieszkowska A, Dupont H, Ouattara A, Leprince P, Chastre J, Combes A. The PRESERVE mortality risk score and analysis of long-term outcomes after extracorporeal membrane oxygenation for severe acute respiratory distress syndrome. Intensive Care Med. 2013 Oct;39(10):1704-13. doi: 10.1007/s00134-013-3037-2. Epub 2013 Aug 2.


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.

primary_purpose: Prevention

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


title: First in Man Study Investigating the Biodistribution, the Safety and Optimal Recommended Dose of a New Radiolabelled Monoclonal Antibody Targeting Frizzled Homolog 10 (FZD10) in Patients With Relapsed or Refractory Non Resectable Synovial Sarcomas

acronym: SYNFRIZZ

summary:
Advanced synovial sarcoma represents an unmet medical need. The gene encoding frizzled homologue 10 (FZD10), a 7-transmenbrane receptor, member of the Wnt signalling receptor family, is overexpressed in SS and is undetectable in normal human tissues except placenta.

OncoTherapy Science Inc. has developed a chimeric humanized monoclonal antibody (mAb) against FZD10, named OTSA101. Non-radiolabeled OTSA101 antibody has only weak antagonistic activity on SS cell growth. However, Yttrium 90-radiolabeled OTSA101 (OTSA101-DTPA-90Y) showed significant antitumor activity following a single intravenous injection in mouse xenograft model.

This first in man clinical trial (Phase I) in relapsing SS patients resistant to Doxorubicin and ifosfamide will be divided in 2 parts.

In Part 1 (imaging part using OTSA101 radiolabelled with Indium 111 [111In]), the biodistribution and tumor uptake of OTSA101-DTPA-111In will be followed using 111In as radiotracer.

In Part 2 (therapeutic part with OTSA101 radiolabelled with Yttrium 90 [90Y]), the safety and PK profiles of OTSA101-DTPA-90Y will be determined and preliminary efficacy data will be collected.

This first in Man study should allow defining the optimal recommended dose of OTSA101-DTPA-90Y.

Patients will be followed during 1 year.

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ReferenceCitation: Giraudet AL, Cassier PA, Iwao-Fukukawa C, Garin G, Badel JN, Kryza D, Chabaud S, Gilles-Afchain L, Clapisson G, Desuzinges C, Sarrut D, Halty A, Italiano A, Mori M, Tsunoda T, Katagiri T, Nakamura Y, Alberti L, Cropet C, Baconnier S, Berge-Montamat S, Pérol D, Blay JY. A first-in-human study investigating biodistribution, safety and recommended dose of a new radiolabeled MAb targeting FZD10 in metastatic synovial sarcoma patients. BMC Cancer. 2018 Jun 8;18(1):646. doi: 10.1186/s12885-018-4544-x.

lead_sponsor: Centre Leon Berard


title: A Phase I Exploratory Study Evaluating 3 Formulations of LEO 29102 Plus Calcipotriol, Ointment, LEO 29102 Ointment, Calcipotriol Ointment, Daivonex® Ointment and Diprosone® Ointment in the Treatment of Psoriasis

summary: The purpose of the study is to compare the 3 ointment formulations containing LEO 29102 plus calcipotriol and Daivonex® ointment and Diprosone® ointment and to compare LEO 29102 plus calcipotriol to LEO 29102 alone and to calcipotriol alone in the same ointment vehicle, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

lead_sponsor: LEO Pharma

location_facility: CPCAD - Centre de Pharmacologie Clinique Appliquée à la Dermatologie


title: Evaluation of Effect of Low and High-frequencies of Repetitive Transcranial Magnetic Stimulation (rTMS) by the Suppression of P50 Evoked Potential Component (rTMS-P50)

summary:
The repetitive transcranial magnetic stimulation (rTMS) is a recent technique that has demonstrated its efficiency in both depression and schizophrenia. However if its efficiency has been recognized by the scientific community and the clinicians, its action on neurons and cerebral networks remains debated.

In the motor regions, the different rTMS studies generally use frequencies of stimulation of 1 to 40 Hz with differential effects; the low frequencies being associated with an inhibitory effect whereas highest frequencies have rather some facilitator effects as attested by the motor responses. What is valid for the motor system is not however necessarily applicable to other cerebral regions that have different neuronal organizations. If it is easy to observe these opposite effects of rTMS on the motor system (presence or absence of movements), these potential effects on more integrated cortex involved in high level functions have not been proved.

One of the possibilities to interpret the effects of the rTMS in no-motor cerebral regions would be to study the modifications of the EEG before and after rTMS and to see if a differential effect of the high and low frequencies of stimulation exists. Up to now, the studies having coupled these two techniques have observed modifications of the brain electric activity only during some seconds to minutes after rTMS, what appears in contrast with the clinical effects observed after a long delay (several days).

The contribution of our research resides in the use of the paradigm of suppression of P50 evoked potential component before and after rTMS tested with low and high frequencies of stimulation. This paradigm consists in two identical auditory stimuli presented at a very short interval (generally 500 milliseconds), the second sound generating a P50 wave of weaker amplitude than the first or being completely abolished in healthy subjects. However, this effect that has been well studied could result from an inhibitory action due to the gabaergic interneurons on the pyramidal neurons of the cortex. Thus, the investigators hypothesize that high frequency rTMS would have a facilitator effect on temporal lobe and so would induce no suppression of the P50 after-rTMS whereas low frequency rTMS would induce an inhibitory effect marked by a greater suppression of the P50.

Methods: 30 healthy subjects (of which 16 women) will be included after written consent. They will receive after randomization 2 sessions of rTMS in cross over at 1Hz and 20Hz at 30 days interval. An EEG and a P50 evoked potential will be done before and after rTMS. The site of stimulation will be determined by neuronavigation and will correspond to the maximal activation cluster generated by a language task during functional magnetic resonance imaging. The main judgment criterion is the S2/S1 ratio of the P50. The potential secondary effects will be evaluated (UKU adapted). The secondary criteria are the comparisons before and after rTMS of EEG spectrums in the alpha, beta and gamma bands.

primary_purpose: Basic Science

location_facility: Caen University Hospital, department of psychiatry and explorations fonctionnelles neurologiques


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


acronym: LIFSCREEN

summary: The purpose of this study is to compare the diagnostic efficacy of two follow-up schedules for the early detection of cancers in the population under study on cancer incidence at 3 years.

ReferenceCitation: Caron O, Frebourg T, Benusiglio PR, Foulon S, Brugières L. Lung Adenocarcinoma as Part of the Li-Fraumeni Syndrome Spectrum: Preliminary Data of the LIFSCREEN Randomized Clinical Trial. JAMA Oncol. 2017 Dec 1;3(12):1736-1737. doi: 10.1001/jamaoncol.2017.1358.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


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.

lead_sponsor: Air Liquide Santé International


title: Contribution of Actigraphy for the Evaluation of Elbow Range of Motion in the Joint Assessment in Gerontology

acronym: BIOVAL

summary: In this study, the investigators will measure range of motion of the elbow in a geriatric assessment in 85 subjects aged 65 years or over. These measures will be made by an actigraph and the software analysis BioVal. This technique will be compared with the standard technique (inclinometer). It will also be evaluated during this study, the ease of use and feedback.

status: Unknown status

study_completion_date_type: Anticipated

ReferenceCitation: Sacco G, Turpin JM, Marteu A, Sakarovitch C, Teboul B, Boscher L, Brocker P, Robert P, Guerin O. Inertial sensors as measurement tools of elbow range of motion in gerontology. Clin Interv Aging. 2015 Feb 23;10:491-7. doi: 10.2147/CIA.S70452. eCollection 2015.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Centre Memoire Ressources et Recherche, CHU de Nice

intervention_type: Device


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.


title: Exploratory Study Evaluating the Efficacy and the Tolerability of the Sequential Application of Two Marketed Products in Patients With Acne Vulgaris, Using a Split-Face Model

summary: The aim of this proof of principle study is to evaluate efficacy and safety of the sequential application of two marketed products for the treatment of acne vulgaris, using the Split-Face model


title: Evaluation of Beauty Care Before Chemotherapy in Women With Breast Cancer

acronym: BEAUTY

summary: Evaluation of beauty care in women receiving adjuvant chemotherapy for breast cancer

ReferenceCitation: Saghatchian M, Lacas B, Charles C, Ghouadni A, Clain GT, Boinon D, Delaloge S, Vaz-Luis I, Dauchy S, Amiel P. BEAUTY and the breast: is adjuvant chemotherapy the right time for a beauty boost? Lessons learned from a large randomized controlled trial. Qual Life Res. 2022 Mar;31(3):723-732. doi: 10.1007/s11136-021-02947-6. Epub 2021 Jul 29.


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: Pulmonary Embolism in Mechanically Ventilated Patients Requiring Computed Tomography: Prevalence, Risk Factors and Outcome

acronym: PEICU

summary: The primary objective of this study was to estimate the prevalence of PE among consecutive ICU patients receiving MV who required thoracic computed tomography (CT) with contrast agent injection, regardless of whether PE was suspected clinically. The secondary objectives were to assess the association between PE and DVT, to identify risk factors for VTE, and to determine the outcome of VTE.

ReferenceCitation: Minet C, Lugosi M, Savoye PY, Menez C, Ruckly S, Bonadona A, Schwebel C, Hamidfar-Roy R, Dumanoir P, Ara-Somohano C, Ferretti GR, Timsit JF. Pulmonary embolism in mechanically ventilated patients requiring computed tomography: Prevalence, risk factors, and outcome. Crit Care Med. 2012 Dec;40(12):3202-8. doi: 10.1097/CCM.0b013e318265e461.

lead_sponsor: University Hospital, Grenoble


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.

location_facility: Centre d'investigation clinique HOPITAL GEORGE POMPIDOU


title: Effect of Endotracheal Tube With Taper-shaped Cuff on Incidence of Postoperative Pneumonia After Aortic Surgery

acronym: TETRIS

summary: The incidence of postoperative pneumonia after aortic surgery reaches 60%. In experimental lung model, endotracheal tube with taper-shaped cuff has been shown to decrease microaspiration. This effect has never been demonstrated in patients. The investigators hypothesize that use of endotracheal tube with taper-shaped cuff decreases the incidence of postoperative pneumonia in patients after aortic surgery.

ReferenceCitation: Lucangelo U, Zin WA, Antonaglia V, Petrucci L, Viviani M, Buscema G, Borelli M, Berlot G. Effect of positive expiratory pressure and type of tracheal cuff on the incidence of aspiration in mechanically ventilated patients in an intensive care unit. Crit Care Med. 2008 Feb;36(2):409-13.

ReferenceCitation: Nseir S, Zerimech F, Fournier C, Lubret R, Ramon P, Durocher A, Balduyck M. Continuous control of tracheal cuff pressure and microaspiration of gastric contents in critically ill patients. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1041-7. doi: 10.1164/rccm.201104-0630OC.

ReferenceCitation: Dave MH, Frotzler A, Spielmann N, Madjdpour C, Weiss M. Effect of tracheal tube cuff shape on fluid leakage across the cuff: an in vitro study. Br J Anaesth. 2010 Oct;105(4):538-43. doi: 10.1093/bja/aeq202. Epub 2010 Aug 3.

ReferenceCitation: Hortal J, Giannella M, Pérez MJ, Barrio JM, Desco M, Bouza E, Muñoz P. Incidence and risk factors for ventilator-associated pneumonia after major heart surgery. Intensive Care Med. 2009 Sep;35(9):1518-25. doi: 10.1007/s00134-009-1523-3. Epub 2009 Jun 26.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: Réanimation polyvalente, Département d'Anesthésie-Réanimation, Groupe Hospitalier Pitié-Salpêtrière


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: Etude peropératoire de la Perfusion Sanguine Des Carcinomes Basocellulaires Par Imageur Laser Doppler, au Cours de la Manipulation de l'Influx artériel Tumoral - Recherche d'un phénomène d'hyperémie Tumorale Post-occlusive

acronym: HPOB

summary:
The investigators aim to test the hypothesis and to proof thank to laser speckle contrast imaging that post-occlusive reactive hyperemia (PORH) can be induced through a tumor, in this case, through a basal cell carcinoma, which will be used as a model of study of tumor vasculature.

This new concept of tumor perfusion artificial increase could be used in the future for malignant tumors treatment, in order to increase tumor mean oxygen partial pressure (thus decreasing tumor hypoxia, hallmark of malignant tumors) during cancerology therapies, like radiotherapy and/or chemotherapy, and increase their efficacy.

This clinical trial will use skin flap model for trunk and facial basal cell carcinoma (BCC), with respect the classical excision margin of BCC surgery (3-4mm): after local anesthesia, a little random pattern skin flap will be raised around the BCC, then the cutaneous pedicle will be clamped with surgical clamp for 3 minutes and clamp released.

In case of limb BCC, limb tourniquet will be used, and occluded during 3 minutes upstream to the BCC location.

During all steps of experimentation, laser speckle imaging will be used to measure continuously the peri-tumoral and tumoral perfusion, start from tumor excision, up to10 minutes after tumor pedicle clamp or tourniquet release.

ReferenceCitation: Reyal J, Lebas N, Fourme E, Guihard T, Vilmer C, Le Masurier P. Post-occlusive reactive hyperemia in basal cell carcinoma and its potential application to improve the efficacy of solid tumor therapies. Tohoku J Exp Med. 2012 Jun;227(2):139-47.

lead_sponsor: Institut Curie


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


summary:
The primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet given once daily compared to a placebo tablet in the treatment of house dut mite allergic rhinits.

Additionally the secondary objective of the trial is to evaluate the safety and tolarability of the ALK house dust mite tablet.

Immunotherapy has been shown to provide therapeutic benefits to subjects with house dust mite induced allergy. This trial is planned to investigate if clinically relevant improvements in rhinitis symptoms and with less use of symptomatic medication can be obtained in subjects with a history of poor didease control despite of use of symptomatic medications.

ReferenceCitation: Bernstein DI, Kleine-Tebbe J, Nelson HS, Bardelas JA Jr, Sussman GL, Lu S, Rehm D, Svanholm Fogh B, Nolte H. SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration. Ann Allergy Asthma Immunol. 2018 Jul;121(1):105-110. doi: 10.1016/j.anai.2018.04.007. Epub 2018 Apr 12.

lead_sponsor: ALK-Abelló A/S

location_facility: Department of Respiratory Diseases, Lapeyronie Hospital

intervention_type: Biological


title: Modification of Human Gut Microbiota in Massive Obesity After Bariatric Surgery: the Role of Energetic Restriction

acronym: microbaria

summary:
Gut microbiota ecology is altered in obesity and could link obesity and its complications. Bariatric surgery enables a major and sustained weight loss therefore improving obesity related disease.

the investigators primary aim is to evaluate gut microbiota adaptation to weight loss and the specific role of energetic restriction. Furthermore we aim to compare gut flora of obese patients post bariatric surgery to that of lean healthy volunteers.

Thus, the investigators plan to compare gut microbiota from 140 obese individuals before and after either restrictive (gastric banding) procedures or gastric bypass procedures to that of 40 lean healthy volunteers at baseline.

primary_purpose: Other

ReferenceCitation: Aron-Wisnewsky J, Prifti E, Belda E, Ichou F, Kayser BD, Dao MC, Verger EO, Hedjazi L, Bouillot JL, Chevallier JM, Pons N, Le Chatelier E, Levenez F, Ehrlich SD, Dore J, Zucker JD, Clément K. Major microbiota dysbiosis in severe obesity: fate after bariatric surgery. Gut. 2019 Jan;68(1):70-82. doi: 10.1136/gutjnl-2018-316103. Epub 2018 Jun 13.


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

source: euctr

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.

lead_sponsor: Centre Hospitalier Universitaire Dijon


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


type: Other Grant/Funding Number

title: Pilot Study 1 of Outpatient Control-to-Range - System and Monitoring Testing

summary:
A single arm, single treatment study is proposed to assess the feasibility of a portable artificial pancreas system outside of a hospital based clinical research center.

Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions (hotel).

ReferenceCitation: Kovatchev BP, Renard E, Cobelli C, Zisser HC, Keith-Hynes P, Anderson SM, Brown SA, Chernavvsky DR, Breton MD, Farret A, Pelletier MJ, Place J, Bruttomesso D, Del Favero S, Visentin R, Filippi A, Scotton R, Avogaro A, Doyle FJ 3rd. Feasibility of outpatient fully integrated closed-loop control: first studies of wearable artificial pancreas. Diabetes Care. 2013 Jul;36(7):1851-8. doi: 10.2337/dc12-1965.

lead_sponsor: University of Virginia

location_facility: Centre d'Investigation Clinique CHU Montpellier


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.

status: Suspended


title: Evaluation of Oxidative Stress Induced by Iron Injection in Healthy Volunteers Versus Critical Care Patients

acronym: SOFI

summary:
The purpose of this study is to evaluate the pro-oxidant toxicity of iron injections in critically ill patients and in healthy volunteers. The investigators hypothesize that the inflammatory state of critically ill patients will reduce the oxydative stress induced by iron injections, compared to the one induced in healthy volunteers. It will be an open "proof-of-concept" study aimed at evaluating iron toxicity in critically ill patients (n=40) as compared to healthy volunteers (n=40).

The investigators will compare the oxidative stress (principal judgment criteria= 8-iso-PGF2α) following a 100 mg injection of iron (at T0, T2, T6 and T24 hours post injection) in both groups and the investigators will compare the effect of repeated injections in the critically ill patients.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Observational Study of Patients With Pre Capillary Pulmonary Hypertension

acronym: HYPID

summary: HYPID study is an observational and prospective study of patients with interstitial lung disease and pre capillary hypertension diagnosed by right heart sided catheterization. The primary aim of the study is to identify prognostic factors.

lead_sponsor: Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires


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.

lead_sponsor: University Hospital, Bordeaux


acronym: METHEP 2

title: Phase II Multicentric Randomized Trial, Evaluating the Best Protocol of Chemotherapy, Associated With Targeted Therapy According to the Tumor KRAS Status, in Metastatic Colorectal Cancer (CCRM) Patients With Initially Non-resectable Hepatic Metastases

lead_sponsor: UNICANCER

ReferenceCitation: Bidard FC, Kiavue N, Ychou M, Cabel L, Stern MH, Madic J, Saliou A, Rampanou A, Decraene C, Bouché O, Rivoire M, Ghiringhelli F, Francois E, Guimbaud R, Mineur L, Khemissa-Akouz F, Mazard T, Moussata D, Proudhon C, Pierga JY, Stanbury T, Thézenas S, Mariani P. Circulating Tumor Cells and Circulating Tumor DNA Detection in Potentially Resectable Metastatic Colorectal Cancer: A Prospective Ancillary Study to the Unicancer Prodige-14 Trial. Cells. 2019 May 28;8(6). pii: E516. doi: 10.3390/cells8060516.

summary:
The main objective is to compare resection rates (R0 or R1) for hepatic metastases in the experimental arm (tri chemotherapy plus targeted therapy) versus the control arm (bi chemotherapy plus targeted therapy); in both arms the targeted therapy is selected according to K-Ras status of the patient's tumor.

The secondary objectives are to evaluate the objective response rate (CR and PR) after 4 cycles of treatment, according the RECIST V1.1 evaluation scale.

the rate of complete remission (CR) at 6 months after the last study treatment (hepatic surgery or last chemotherapy cycle).
the specific rates of resection R0, R1, R2.
the complete pathological response Rate,
the relapse-free survival rate in (R0 or R1) resected patients,
the response duration in non-resected patients,
the toxicity according to CTC AE V4 scale except for the neurotoxicity that will be evaluated with the Levi scale,
the post operative complications using the DINDO classification,
the progression-free survival (PFS) and overall survival (OS).

The objectives of the biological study are:

to evaluate tumor-related predictive factors such as somatic mutations (KRAS, BRAF, TP53) and genetic amplification related factors (EGFR),
to evaluate patient-related predictive factors in connection with genetic polymorphisms (Fc gamma and VEGF receptors),
to evaluate ADCC activity via immunohistochemistry in order to analyze the lympho free and progression-free survival,
to study circulating of tumor cells as prognostic factor for metastatic colorectal cancer, non- resectable at presentation.


acronym: PREMILOC

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

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.

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.

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.

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.

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.

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.

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: Pilot Study on the Usefulness of 3,4-diaminopyridine in the Treatment of Botulism

summary:
Main objectives:

Evaluate the effectiveness of an administration of 3,4-diaminopyridine (FIRDAPSE ®) in severe botulinic poisoning in measuring the effect on electrophysiological and respiratory parameters

Secondary Objective:

Study the natural history of electrophysiological and respiratory parameters during the botulinic intoxication

Primary endpoint:

Clinical, electrophysiological and respiratory before and after administration of 3,4-diaminopyridine.

Study Design:

Pilot study, prospective, interventional.

Study population:

Case series (n = 8 patients) suffering from botulinic type A, respiratory failure, but with no other organ failure

Experimental treatment :

3,4-diaminopyridine, FIRDAPSE ® (BioMarin) The dosage will be gradually increased according to a predetermined scheme and will not exceed 60 mg / day and 20 mg / dose.

Statistics:

Intra-individual comparison of physiological parameters measured before and after administration of 3,4-diaminopyridine. Electromyographic and respiratory parameters will be measured for each patient. Then a dose of 10 mg of 3,4-diaminopyridine will be administrated. If this dose is well tolerated and provides a relative improvement of 10% for at least one of the parameters studied, the dose will be maintained at 10 mg for 48 hours 3 times a day then increased to 20 mg.

The primary endpoint is the change in the amplitude of muscle response evaluated by the subtraction of amplitude at T1.5 and T0.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


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: Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease

acronym: Kawasaki

summary:
Kawasaki disease (KD) is an acute systemic vasculitic syndrome with coronary tropism.

It has been reported worldwide, but it is ten times more common in Asian population. The annual incidence in children under 5 years in Europe is estimated at 8 to 100000. It is the second vasculitis of the child by its frequency after rheumatoid purpura. It occurs in 80% of cases between 1 and 5 years, with a maximal incidence around the age of 12 months.

It may results in acquired heart disease in children in developed countries, and may be the cause of premature coronary artery disease in adulthood.

A polymorphism was recently associated with the occurrence of disease in a Japanese and U.S population. (C allele of SNP itpkc_3, with a risk multiplied by 2). However, data are conflicting on this issue and the prevalence of this allel is unknown in North America and Europe populations.

The clinical picture of KD associate a persistent fever and an antipyretics resistance with mucocutaneous signs and bulky cervical lymphadenopathy usually unilateral. Diagnosis is confirmed by the presence of five clinical signs (major criteria). The presence of inconsistent coronary lesions in cardiac ultrasound can confirm the diagnosis.

KD can resolve spontaneously with no treatment. The severity of the disease is primarily related to complications of coronary aneurysms in acute or chronic stages.

Several arguments support the fact that adult patients have diffuse vascular lesions different from aneurysmal lesions initially described in childhood.

Despite abundance of publications on KD, there is no prospective or retrospective study which explored anomalies resulting from KD in adult subjects.

Therefore, this project will describe the patient's vascular evolution, the prevalence of atherosclerotic lesions and to determine the biological and functional abnormalities, markers of accelerated atherosclerosis.

Hypothesis : A history of Kawasaki disease represents a cardiovascular risk factor in adulthood.

The main objective is to evaluate the prevalence of atherosclerotic lesions, their extent and their severity in adults with a history of KD in childhood compared to a control population.

primary_purpose: Health Services Research

lead_sponsor: Hospices Civils de Lyon


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.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Maintenance Oral Nifedipine for Management of Symptomatic Placenta Previa : A Randomized Clinical Trial

summary:
The objective of our study is to determine the clinical utility related to the maintenance oral nifedipine therapy in patients with symptomatic placenta previa. This study is a prospective, randomized controlled trial with the inclusion, after 24 weeks gestation, of hospitalized patients with symptomatic placenta praevia. All patients may initially receive oral nifedipine therapy with steroid prophylaxis for 48 hours. After then, patients are randomly assigned to receive either oral nifedipine (20 mg every 8 hours) or placebo (one every 8 hours) until 37 weeks of gestation.

The primary outcome for the trial is the length of pregnancy in days after the enrollment. A sample size calculation is designed to detect at least a 14 -day difference in time gained in patients with maintenance oral nifedipine therapy. A sample size of about 52 patients per group would have a 80 % chance of detecting this difference at the 5 % level of significance.

ReferenceCitation: Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8:CD014978. doi: 10.1002/14651858.CD014978.pub2. Review.

ReferenceCitation: Verspyck E, de Vienne C, Muszynski C, Bubenheim M, Chanavaz-Lacheray I, Dreyfus M, Deruelle P, Benichou J. Maintenance nifedipine therapy for preterm symptomatic placenta previa: A randomized, multicenter, double-blind, placebo-controlled trial. PLoS One. 2017 Mar 23;12(3):e0173717. doi: 10.1371/journal.pone.0173717. eCollection 2017.

lead_sponsor: University Hospital, Rouen


title: Body Image Therapy in Anorexia Nervosa

acronym: PIPA

summary: The purpose of the study is to test a new procedure of body image therapy in anorexia nervosa, using the anamorphic micro software.

lead_sponsor: Centre Hospitalier St Anne


title: Is There a Benefit to Optimize HF (Heart Failure) Treatment in Aged Over 80 Year's Old Patients?

acronym: HF 80

summary: The purpose of this study is to determine if there is an interest to optimize HF (heart failure) management in patients over 80 years old. The primary objective is to assess the effect of HF (heart failure) optimized management (guidelines of the European society of Cardiology (ESC) on Quality of Life (QOL) in aged over 80 year's old at 6 months.

ReferenceCitation: Eschalier R, Jean F, Pereira B, Monzy S, Vorilhon C, Mactoux V, Citron B, Sapin V, Motreff P, Lusson JR. Is there benefit in optimising heart failure treatment in over-80 year-old patients? (HF-80 study): study protocol for a randomized controlled trial. Trials. 2012 Mar 6;13:25. doi: 10.1186/1745-6215-13-25.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Assessment of the Use of Fixed Doses of Artesunate Plus Amodiaquine Combination for the Home Management of Presumed Malaria in Malagasy Children

summary: The purpose of this study is to assess the feasibility, the acceptability and the effectiveness of the use of the Artesunate + Amodiaquine Fixed Dose Combination for the home management of presumed malaria in Malagasy children by the community-based service providers.

ReferenceCitation: Ratsimbasoa A, Ravony H, Vonimpaisomihanta JA, Raherinjafy R, Jahevitra M, Rapelanoro R, Rakotomanga Jde D, Malvy D, Millet P, Ménard D. Management of uncomplicated malaria in febrile under five-year-old children by community health workers in Madagascar: reliability of malaria rapid diagnostic tests. Malar J. 2012 Mar 25;11:85. doi: 10.1186/1475-2875-11-85.

lead_sponsor: National Malaria Control Programme, Madagascar


title: Comparison of Diagnostic Performance of an Algorithm and a High Definition Classical Iterative Algorithm Positron Emission Tomography (PET) to 18Fluoro-deoxy-glucose (18FDG) in the Evaluation of Axillary Lymph Node Invasion of Breast Tumors

acronym: TEP-Sein

summary: The primary endpoint of this study is to show that this algorithm in high definition is superior to the classical algorithm in the diagnosis of lymph node metastases.

lead_sponsor: Centre Francois Baclesse


title: Phase II Study of Combined Oxaliplatin and Paclitaxel for Metastatic Germ Cell Tumors

summary: To evaluate the efficacy of the oxaliplatin-paclitaxel combination i.e. evaluation of tumor response rate using World Health Organization/Union Internationale Contre le Cancer (WHO/UICC) and Indianapolis tumor marker (human chorionic gonadotropin [hCG], alpha fetoprotein [AFP]) criteria in metastatic germ cell cancer patients

lead_sponsor: Sanofi


title: Comparison of the Rates of Fetal Extractions Between a Systematic Practice of an Echography of Presentation and the Only Vaginal Touch Usually Realized During the Labor

acronym: PINKFINGER

summary: The main objective of this study is to compare the rate of fetal extractions between a systematic practice of an echography of presentation and the vaginal touch only one usually realized during the labor.


title: VACCILUP "A Multicenter, Randomized Double-blind Trial Comparing Two Pneumococcal Vaccination Strategies in Patients With Systemic Lupus Erythematosus"

acronym: VACCILUP

summary: The aim of this study is to compare the immunological efficacy of two pneumococcal vaccination strategies in patients with systemic lupus erythematosus (SLE) treated with corticosteroids associated or not with other immunosuppressive drugs : 1) a prime-boost strategy using vaccination with conjugate vaccine (Prevenar®) at week 0 and Poly Saccharidic vaccine (Pneumo23®) after 6 months (W24)2) compared to the standard vaccination with Poly Saccharidic vaccine (Pneumo23®) at W24 after placebo at W0

ReferenceCitation: Grabar S, Groh M, Bahuaud M, Le Guern V, Costedoat-Chalumeau N, Mathian A, Hanslik T, Guillevin L, Batteux F, Launay O; VACCILUP study group. Pneumococcal vaccination in patients with systemic lupus erythematosus: A multicenter placebo-controlled randomized double-blind study. Vaccine. 2017 Sep 5;35(37):4877-4885. doi: 10.1016/j.vaccine.2017.07.094. Epub 2017 Aug 4.


title: Sulfonylureas in Neonatal Diabetes Mellitus With Mutations of 2 Type of Subunits Kir6.2 and SUR1 of the Pancreatic Beta-cell ATP-sensitive K+ Channel.

summary: The aim of our trial is to try to switch patients with permanent neonatal diabetes mellitus due to a Kir6.2 or SUR1 activating mutation from subcutaneous insulin to oral glibenclamide therapy.

ReferenceCitation: Beltrand J, Elie C, Busiah K, Fournier E, Boddaert N, Bahi-Buisson N, Vera M, Bui-Quoc E, Ingster-Moati I, Berdugo M, Simon A, Gozalo C, Djerada Z, Flechtner I, Treluyer JM, Scharfmann R, Cavé H, Vaivre-Douret L, Polak M; GlidKir Study Group. Sulfonylurea Therapy Benefits Neurological and Psychomotor Functions in Patients With Neonatal Diabetes Owing to Potassium Channel Mutations. Diabetes Care. 2015 Nov;38(11):2033-41. doi: 10.2337/dc15-0837. Epub 2015 Oct 5. Erratum in: Diabetes Care. 2016 Jan;39(1):175.

location_facility: Necker Hospital - Endocrinology Gynecology Pediatric unit


title: Synthesis of Glutathione in Erythrocytes From Low Birth Weight Newborn Babies : Effect of Cysteine in Vitro

acronym: glutathione

summary: The aim of the study is to determine mechanisms leading to glutathione deficiency in low birth weight newborn babies. Compared to full term neonates, depletion in this population may be due to a decreased synthesis rate or to an enhanced utilization or a combination of both mechanisms.The protocol is constituted of two steps. The objective of the first step is to quantify the blood concentration of glutathione in the artery and the vein of umbilical cord in full term newborn babies. Objectives of the second step are to determine if the glutathione synthesis rate, measured in vitro, is lower in erythrocytes collected from umbilical cord blood of low weight newborn babies compared to full term newborn babies. In this case, the next objective will be to determine if the adjunction of an excess of cysteine in vitro can restore the glutathione synthesis rate in these cells.

ReferenceCitation: De Luca A, Küster A, Tea I, Darmaun D, Rozé JC, Robins R, Hankard R. Plasma amino acid pools in the umbilical cord artery show lower (15)N natural isotope abundance relative to the maternal venous pools. Isotopes Environ Health Stud. 2021 Mar;57(1):3-10. doi: 10.1080/10256016.2020.1817914. Epub 2020 Sep 24.

lead_sponsor: Nantes University Hospital


title: Interest in Biventricular Epicardial Pacing Post Cardiac Surgery in Patients With Left Ventricular Ejection Fractions Less Than 45%

summary: Patients with reduced left ventricular function are at an increased perioperative risk and often need prolonged postoperative treatment on intensive care units. A significant portion of these patients require postoperative pacing. Right ventricular pacing has been shown to be hemodynamically deleterious The aim of this study is to determine which biventricular pacing after cardiac surgery, in patients with reduced left ventricular function (EF≤ 45%), is hemodynamically favourable.

ReferenceCitation: Forestier C, Guelon D, Cluytens V, Gillart T, Sirot J, De Champs C. Oral probiotic and prevention of Pseudomonas aeruginosa infections: a randomized, double-blind, placebo-controlled pilot study in intensive care unit patients. Crit Care. 2008;12(3):R69. doi: 10.1186/cc6907. Epub 2008 May 20.


title: Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-clavulanic Acid

acronym: INWARA

summary:
Several case reports indicate that the use of the antibiotic combination amoxicillin and clavulanic acid (AM-CLAVAC) can interact with warfarin pharmacodynamics. However, fever per se might also be responsible of these warfarin overdose reports, as well as the use of high dose paracetamol.

The aim of the present study is to determine if AM-CLAVAC can increase the pharmacodynamics of warfarin among patients at steady state Double blinded cross over controlled study vs placebo performed in 12 evaluable patients treated with warfarin with an INR target 2 to 3 and a stable INR and a stable dose.

location_facility: Hopital Lariboisière - Service de médecine interne


title: Interest of Using Nocturnal Polysomnography for Non-Invasive Ventilation (NIV) Settings' Optimization in Obesity-Hypoventilation Syndrome (OHS)

acronym: NIV-OHS

summary: The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings. In one arm settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas in the other arm patients will benefit from a complete polysomnography under NIV.

ReferenceCitation: Borel JC, Tamisier R, Gonzalez-Bermejo J, Baguet JP, Monneret D, Arnol N, Roux-Lombard P, Wuyam B, Levy P, Pépin JL. Noninvasive ventilation in mild obesity hypoventilation syndrome: a randomized controlled trial. Chest. 2012 Mar;141(3):692-702. doi: 10.1378/chest.10-2531. Epub 2011 Sep 1.

ReferenceCitation: Borel JC, Roux-Lombard P, Tamisier R, Arnaud C, Monneret D, Arnol N, Baguet JP, Levy P, Pepin JL. Endothelial dysfunction and specific inflammation in obesity hypoventilation syndrome. PLoS One. 2009 Aug 24;4(8):e6733. doi: 10.1371/journal.pone.0006733.

lead_sponsor: Tyco Healthcare Group

location_facility: Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires - CHU Grenoble


title: A Multicenter, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance and Safety/Tolerability of SSR180711C for 4 Weeks, Using Donepezil as Calibrator, in Patients With Mild Alzheimer's Disease

summary: The primary objective of the study is to assess the effect of 3 doses of SSR180711C on cognitive performance in patients with mild Alzheimer's Disease (AD). Other objectives are to assess the safety/tolerability of SSR180711C in patients with mild AD.


title: A Multicentric Phase II-III Randomized Study Safety of Intraveinous Liposomal Pegylated Doxorubicin Versus Continuous Infusion of Doxorubicin During Induction Treatment of Acute Lymphoblastic Leukemia in Patients

summary: Phase II multicentric study comparing VAD regimen with continuous infusion over 96 hours of doxorubicin, vincristine and dexamethasone to a 90 minutes infusion of equivalent doses of Dox li-PEG, bolus infusion of vincristine and dexamethasone

ReferenceCitation: Hunault-Berger M, Leguay T, Thomas X, Legrand O, Huguet F, Bonmati C, Escoffre-Barbe M, Legros L, Turlure P, Chevallier P, Larosa F, Garban F, Reman O, Rousselot P, Dhédin N, Delannoy A, Lafage-Pochitaloff M, Béné MC, Ifrah N, Dombret H; Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL). A randomized study of pegylated liposomal doxorubicin versus continuous-infusion doxorubicin in elderly patients with acute lymphoblastic leukemia: the GRAALL-SA1 study. Haematologica. 2011 Feb;96(2):245-52. doi: 10.3324/haematol.2010.027862. Epub 2010 Oct 22.

lead_sponsor: French Innovative Leukemia Organisation


title: Randomized Double Blind Placebo-controlled Trial of the Efficacy of an Anti-TNF Alpha Agent (Adalimumab, Humira®) in Patients With Incapacitating Hand Osteoarthritis Refractory to Usual Treatment

acronym: DORA

summary:
Digital osteoarthritis (DO) which affects the interphalangeal joints and the Metacarpophalangeal (MCP) of the thumb is a common disease, the prevalence of which increases with age (36% of the population aged over 70). Certain forms of DO with clinical manifestations involving inflammatory features are particularly refractory to usual treatments (analgesics, NSAIDs, braces and local injections). The mechanism of osteoarthritis involves two major cytokines: interleukin-1 beta and tumor necrosis factor alpha. TNF alpha is particularly involved in the inflammation process.

The aim of the present study is to study the efficacy of TNF alpha blockers (2 injections of adalimumab compared to placebo injections in patients with severe and refractory hand osteoarthritis.

We hope that such new therapeutic option may induce substantial pain relief.

ReferenceCitation: Chevalier X, Ravaud P, Maheu E, Baron G, Rialland A, Vergnaud P, Roux C, Maugars Y, Mulleman D, Lukas C, Wendling D, Lafforgue P, Loeuille D, Foltz V, Richette P; French section of osteoarthritis. Adalimumab in patients with hand osteoarthritis refractory to analgesics and NSAIDs: a randomised, multicentre, double-blind, placebo-controlled trial. Ann Rheum Dis. 2015 Sep;74(9):1697-705. doi: 10.1136/annrheumdis-2014-205348. Epub 2014 May 9.

lead_sponsor: Assistance Publique - Hôpitaux de Paris