title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

acronym: RAINIER

summary: The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.

ReferenceCitation: Raghu G, Brown KK, Collard HR, Cottin V, Gibson KF, Kaner RJ, Lederer DJ, Martinez FJ, Noble PW, Song JW, Wells AU, Whelan TP, Wuyts W, Moreau E, Patterson SD, Smith V, Bayly S, Chien JW, Gong Q, Zhang JJ, O'Riordan TG. Efficacy of simtuzumab versus placebo in patients with idiopathic pulmonary fibrosis: a randomised, double-blind, controlled, phase 2 trial. Lancet Respir Med. 2017 Jan;5(1):22-32. doi: 10.1016/S2213-2600(16)30421-0. Epub 2016 Dec 7.

ReferenceCitation: Humphries SM, O'Riordan TG, Zhang JJ, Bayly S, Sood R, Hayden A, Lynch DA; Relationship Baseline Fibrosis Score to Lung Function in A Clinical Trial Population with Idiopathic Pulmonary Fibrosis. ATS International Conference, 2016 May 13-18, San Francisco CA.

ReferenceCitation: Raghu G, Brown K, Collard H, Lederer D, Martinez F, Noble P, Song JW, Wells A, Whelan T, Moreau E, Patterson S, Bayly S, Chien J, Zhang J, O'Riordan T; Simtuzumab in Idiopathic Pulmonary Fibrosis: Results of a Randomized Clinical Trial. ERS Congress, 2016 September 3-7, London, UK.

ReferenceCitation: Raghu G, Brown KK, Collard HR, Lederer DJ, Martinez FJ, Noble PW, Song JW, Wells AU, Whalen TP, Lambert L, Chien JW, Zhang JJ, O'Riordan TG; Simtuzumab in Idiopathic Pulmonary Fibrosis (IPF): Baseline Demographic and Lung Function Data from a Clinical Trial. ATS International Conference, 2016 May 13-18, San Francisco CA.

lead_sponsor: Gilead Sciences

location_country:
Italy
United States
Switzerland
Germany
France
Czechia
Poland
Israel
Belgium
Australia
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Centre Hospitalier Universitaire Hôpital Avicenne

location_facility: Fondazione PTV - Policlinico Tor Vergata

location_facility: Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn

location_facility: Aintree University Hospitals NHS Foundation Trust

location_facility: Saint Luke's Midwest Pulmonary Consultants

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec

location_facility: University of Iowa Hospitals and Clinics

location_facility: David Geffen School of Medicine at University of California, Los Angeles

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)

location_facility: Masarykova nemocnice v Ústí nad Labem o.z.

location_facility: Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH

location_facility: San Giuseppe Hospital, Dept. of Internal Medicine

location_facility: Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: Hôpital Larrey, CHU de Toulouse, Service de Pneumologie

location_facility: Hadassah-Hebrew University Medical Center

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Università degli studi Federico II di Napoli

location_facility: Centre Hospitalier Universitaire Grenoble Hopital Michalon

location_facility: Klinikum Großhadern der Ludwig-Maximilians-Universität München

location_facility: Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou

location_facility: Hospital Universitario Central de Asturias

location_facility: University of California Davis Medical Center

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 3 w Zabrzu Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: 10 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ w Bydgoszczy

location_facility: Washington University School of Medicine

location_facility: Centre Hospitalier Universitaire de Nice-Hôpital Pasteur

location_facility: Seoul National University Bundang Hospital

location_facility: Centre Hospitalier Universitaire Hôpital Nord

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: University of Pittsburgh Presbyterian - Montefiore

location_facility: Froedtert Hospital and Medical College of Wisconsin

location_facility: Temple University Hospital, Temple Lung Center

location_facility: Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)

location_facility: Centre Hospitalier de L'Université de Montréal Hôtel-Dieu

location_facility: Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Universität Freiburg, Klinikum, Abt für Pneumologie

location_facility: Saint Joseph's Hospital and Medical Center

location_facility: University Hospital of South Manchester NHS Foundation Trust


title: Effect of Low Molecular Weight Heparin on Survival of Stage I,II or IIIA Non Small Cell Lung Cancer. A Multicenter, Open, Randomized Controlled Trial.

acronym: TILT

summary: Experiments suggest that low molecular weight heparin (LMWH) inhibits tumor growth and metastasis. Studies in humans suggest that LMWH is associated with a higher survival in patients with cancer related thrombosis. Two recent studies suggest that LMWH may increase the survival of patients with cancer who do not have an associated thrombosis. The purpose of the study is to assess the effect of LMWH on the overall survival of patients with localized non-small cell lung cancer after complete surgical resection.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Alifano M, Benedetti G, Trisolini R. Can low-molecular-weight heparin improve the outcome of patients with operable non-small cell lung cancer? An urgent call for research. Chest. 2004 Aug;126(2):601-7. Review.

ReferenceType: derived

ReferenceCitation: Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12:CD008500. doi: 10.1002/14651858.CD008500.pub5.

name: Institute of Social and Preventive Medicine (ISPM); University of Bern; Bern Switzerland

family: Rutjes

full_name: Anne WS Rutjes

given: Anne WS

sequence: additional

name: Department of Medical, Oral and Biotechnological Sciences; University "G. D'Annunzio" of Chieti-Pescara; Chieti Italy

family: Porreca

full_name: Ettore Porreca

given: Ettore

name: Internal Medicine Unit; "University G. D'Annunzio" Foundation; Chieti Italy

family: Candeloro

full_name: Matteo Candeloro

given: Matteo

family: Valeriani

full_name: Emanuele Valeriani

given: Emanuele

name: Department of Medicine and Ageing Sciences; University "G. D'Annunzio" of Chieti-Pescara; Chieti Scalo Italy

name: Department of Vascular Medicine; Academic Medical Center; Amsterdam Netherlands

family: Di Nisio

full_name: Marcello Di Nisio

given: Marcello

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Meyer G, Besse B, Doubre H, Charles-Nelson A, Aquilanti S, Izadifar A, Azarian R, Monnet I, Lamour C, Descourt R, Oliviero G, Taillade L, Chouaid C, Giraud F, Falcoz PE, Revel MP, Westeel V, Dixmier A, Tredaniel J, Dehette S, Decroisette C, Prevost A, Pichon E, Fabre E, Soria JC, Friard S, Stern JB, Jabot L, Dennewald G, Pavy G, Petitpretz P, Tourani JM, Alifano M, Chatellier G, Girard P. Anti-tumour effect of low molecular weight heparin in localised lung cancer: a phase III clinical trial. Eur Respir J. 2018 Oct 4;52(4). pii: 1801220. doi: 10.1183/13993003.01220-2018. Print 2018 Oct.

family: Meyer

full_name: Guy Meyer

given: Guy

sequence: first

family: Besse

full_name: Benjamin Besse

given: Benjamin

family: Doubre

full_name: Hélène Doubre

given: Hélène

family: Charles-Nelson

full_name: Anaïs Charles-Nelson

given: Anaïs

family: Aquilanti

full_name: Sandro Aquilanti

given: Sandro

family: Izadifar

full_name: Armine Izadifar

given: Armine

family: Azarian

full_name: Reza Azarian

given: Reza

family: Monnet

full_name: Isabelle Monnet

given: Isabelle

family: Lamour

full_name: Corinne Lamour

given: Corinne

family: Descourt

full_name: Renaud Descourt

given: Renaud

family: Oliviero

full_name: Gérard Oliviero

given: Gérard

family: Taillade

full_name: Laurent Taillade

given: Laurent

family: Chouaid

full_name: Christos Chouaid

given: Christos


title: Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients

summary:
Among the different creatinine-based GFR predicting equations, the MDRD equation gives the best prediction in renal transplantation but does not provide the level of accuracy usually seen in renal patients with native kidneys.

Blocking the tubular secretion of creatinine with an oral administration of cimetidine is likely to make creatinine a more accurate marker of GFR.

We will test the hypothesis that the accuracy of the MDRD equation will be improved in renal transplant patients by incorporating into the equation a cimetidine-corrected serum creatinine value.

primary_purpose: Diagnostic

ReferenceType: background

ReferenceCitation: Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41.

ReferenceCitation: Mariat C, Alamartine E, Afiani A, Thibaudin L, Laurent B, Berthoux P, De Filippis JP, Thibaudin D, Mayor B, Elessawy AB, Berthoux F. Predicting glomerular filtration rate in kidney transplantation: are the K/DOQI guidelines applicable? Am J Transplant. 2005 Nov;5(11):2698-703.

ReferenceCitation: Mariat C, Alamartine E, Barthelemy JC, De Filippis JP, Thibaudin D, Berthoux P, Laurent B, Thibaudin L, Berthoux F. Assessing renal graft function in clinical trials: can tests predicting glomerular filtration rate substitute for a reference method? Kidney Int. 2004 Jan;65(1):289-97.

ReferenceCitation: Gaspari F, Ferrari S, Stucchi N, Centemeri E, Carrara F, Pellegrino M, Gherardi G, Gotti E, Segoloni G, Salvadori M, Rigotti P, Valente U, Donati D, Sandrini S, Sparacino V, Remuzzi G, Perico N; MY.S.S. Study Investigators. Performance of different prediction equations for estimating renal function in kidney transplantation. Am J Transplant. 2004 Nov;4(11):1826-35.

ReferenceCitation: Bosma RJ, Doorenbos CR, Stegeman CA, van der Heide JJ, Navis G. Predictive performance of renal function equations in renal transplant recipients: an analysis of patient factors in bias. Am J Transplant. 2005 Sep;5(9):2193-203.

ReferenceCitation: Pöge U, Gerhardt T, Palmedo H, Klehr HU, Sauerbruch T, Woitas RP. MDRD equations for estimation of GFR in renal transplant recipients. Am J Transplant. 2005 Jun;5(6):1306-11.

ReferenceCitation: Poggio ED, Wang X, Weinstein DM, Issa N, Dennis VW, Braun WE, Hall PM. Assessing glomerular filtration rate by estimation equations in kidney transplant recipients. Am J Transplant. 2006 Jan;6(1):100-8.

ReferenceCitation: Kemperman FA, Surachno J, Krediet RT, Arisz L. Cimetidine improves prediction of the glomerular filtration rate by the Cockcroft-Gault formula in renal transplant recipients. Transplantation. 2002 Mar 15;73(5):770-4.

ReferenceCitation: Nankivell BJ, Gruenewald SM, Allen RD, Chapman JR. Predicting glomerular filtration rate after kidney transplantation. Transplantation. 1995 Jun 27;59(12):1683-9.

ReferenceCitation: Myara I, Lahiani F, Cosson C, Duboust A, Moatti N. Estimated creatinine clearance by the formula of Gault and Cockcroft in renal transplantation. Nephron. 1989;51(3):426-7.

ReferenceCitation: Goerdt PJ, Heim-Duthoy KL, Macres M, Swan SK. Predictive performance of renal function estimate equations in renal allografts. Br J Clin Pharmacol. 1997 Sep;44(3):261-5.

ReferenceCitation: Perico N, Gaspari F, Remuzzi G. Assessing renal function by GFR prediction equations in kidney transplantation. Am J Transplant. 2005 Jun;5(6):1175-6.

ReferenceCitation: National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266.

ReferenceCitation: Froissart M, Rossert J, Jacquot C, Paillard M, Houillier P. Predictive performance of the modification of diet in renal disease and Cockcroft-Gault equations for estimating renal function. J Am Soc Nephrol. 2005 Mar;16(3):763-73. Epub 2005 Jan 19.

ReferenceCitation: Poggio ED, Wang X, Greene T, Van Lente F, Hall PM. Performance of the modification of diet in renal disease and Cockcroft-Gault equations in the estimation of GFR in health and in chronic kidney disease. J Am Soc Nephrol. 2005 Feb;16(2):459-66. Epub 2004 Dec 22.

ReferenceCitation: White C, Akbari A, Hussain N, Dinh L, Filler G, Lepage N, Knoll GA. Estimating glomerular filtration rate in kidney transplantation: a comparison between serum creatinine and cystatin C-based methods. J Am Soc Nephrol. 2005 Dec;16(12):3763-70. Epub 2005 Oct 19.

ReferenceCitation: Lemahieu WP, Maes BD, Verbeke K, Vanrenterghem Y. Impact of gastric acid suppressants on cytochrome P450 3A4 and P-glycoprotein: consequences for FK506 assimilation. Kidney Int. 2005 Mar;67(3):1152-60.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: Weaning of Mechanical Ventilation Guided by the Natriuretic Peptide of Type B

acronym: BMW

summary: Several clinical findings and clinical trials have suggested that the prognosis of intensive care unit (ICU) patients may be improved by minimizing the positive fluid balance. In particular, a global vascular overload could lead to weaning failure. The purpose of this international, multicenter, controlled, randomized trial is to test if the incorporation of a B-type natriuretic peptide (BNP) assay in a mechanical ventilation weaning protocol helps optimize the weaning process and reduce the duration of the ventilatory weaning period.

ReferenceCitation: Dessap AM, Roche-Campo F, Launay JM, Charles-Nelson A, Katsahian S, Brun-Buisson C, Brochard L. Delirium and Circadian Rhythm of Melatonin During Weaning From Mechanical Ventilation: An Ancillary Study of a Weaning Trial. Chest. 2015 Nov;148(5):1231-1241. doi: 10.1378/chest.15-0525.

family: Dessap

full_name: Armand Mekontso Dessap

given: Armand Mekontso

family: Roche-Campo

full_name: Ferran Roche-Campo

given: Ferran

family: Launay

full_name: Jean-Marie Launay

given: Jean-Marie

full_name: Anais Charles-Nelson

given: Anais

family: Katsahian

full_name: Sandrine Katsahian

given: Sandrine

family: Brun-Buisson

full_name: Christian Brun-Buisson

given: Christian

family: Brochard

full_name: Laurent Brochard

journal_name: Chest

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Mekontso Dessap A, Katsahian S, Roche-Campo F, Varet H, Kouatchet A, Tomicic V, Beduneau G, Sonneville R, Jaber S, Darmon M, Castanares-Zapatero D, Brochard L, Brun-Buisson C. Ventilator-associated pneumonia during weaning from mechanical ventilation: role of fluid management. Chest. 2014 Jul;146(1):58-65. doi: 10.1378/chest.13-2564.

family: Mekontso Dessap

given: Armand

family: Varet

full_name: Hugo Varet

given: Hugo

family: Kouatchet

full_name: Achille Kouatchet

given: Achille

family: Tomicic

full_name: Vinko Tomicic

given: Vinko

family: Beduneau

full_name: Gaetan Beduneau

given: Gaetan

family: Sonneville

full_name: Romain Sonneville

given: Romain

family: Jaber

full_name: Samir Jaber

given: Samir

family: Darmon

full_name: Michael Darmon

given: Michael

family: Castanares-Zapatero

full_name: Diego Castanares-Zapatero

given: Diego

title: Ventilator-Associated Pneumonia During Weaning From Mechanical Ventilation

ReferenceCitation: Mekontso Dessap A, Roche-Campo F, Kouatchet A, Tomicic V, Beduneau G, Sonneville R, Cabello B, Jaber S, Azoulay E, Castanares-Zapatero D, Devaquet J, Lellouche F, Katsahian S, Brochard L. Natriuretic peptide-driven fluid management during ventilator weaning: a randomized controlled trial. Am J Respir Crit Care Med. 2012 Dec 15;186(12):1256-63. doi: 10.1164/rccm.201205-0939OC. Epub 2012 Sep 20.

journal_name: American Journal of Respiratory and Critical Care Medicine

title: Natriuretic Peptide–driven Fluid Management during Ventilator Weaning


title: Chronic Hemodialysis Without Systemic Heparinization : a Randomized Study

acronym: HDSH

summary: Conventional hemodialysis requires transient systemic anticoagulation to prevent blot clotting after contact with the extracorporeal circuit. However, low molecular weight heparin (LMWH) or unfractioned heparin are contra-indicated in dialysis patients at risk for hemorrhagic complications. In this setting, several procedures theoretically allow dialysis without systemic heparinization, but randomized studies to compare them are lacking. The gold standard is the use of iterative rises of the extra corporeal circuit with isotonic saline (" rises "). Two emerging procedures are increasingly used : continuous pre-dilution of the arterial line (" pre-dilution ") and the use of a specific dialysis membrane (NEPHRAL 400 ST) coated with heparin immediately before use (" heparin adsorption ").

ReferenceCitation: Guéry B, Alberti C, Servais A, Harrami E, Bererhi L, Zins B, Touam M, Joly D. Hemodialysis without systemic anticoagulation: a prospective randomized trial to evaluate 3 strategies in patients at risk of bleeding. PLoS One. 2014 May 13;9(5):e97187. doi: 10.1371/journal.pone.0097187. eCollection 2014.

family: Guéry

full_name: Bruno Guéry

given: Bruno

family: Alberti

full_name: Corinne Alberti

given: Corinne

family: Servais

full_name: Aude Servais

given: Aude

family: Harrami

full_name: Elarbi Harrami

given: Elarbi

family: Bererhi

full_name: Lynda Bererhi

given: Lynda

family: Zins

full_name: Brigitte Zins

given: Brigitte

family: Touam

full_name: Malik Touam

given: Malik

family: Joly

full_name: Dominique Joly

given: Dominique

currency_apc_doaj: USD

journal_name: PLoS ONE

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Hemodialysis without Systemic Anticoagulation: A Prospective Randomized Trial to Evaluate 3 Strategies in Patients at Risk of Bleeding

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Procedure


title: Impact of Procalcitonin to Reduce Antibiotics Use in ICU Adults Patients

acronym: PRORATA

summary: The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.

ReferenceCitation: Bouadma L, Luyt CE, Tubach F, Cracco C, Alvarez A, Schwebel C, Schortgen F, Lasocki S, Veber B, Dehoux M, Bernard M, Pasquet B, Régnier B, Brun-Buisson C, Chastre J, Wolff M; PRORATA trial group. Use of procalcitonin to reduce patients' exposure to antibiotics in intensive care units (PRORATA trial): a multicentre randomised controlled trial. Lancet. 2010 Feb 6;375(9713):463-74. doi: 10.1016/S0140-6736(09)61879-1. Epub 2010 Jan 25.

family: Bouadma

full_name: Lila Bouadma

given: Lila

family: Luyt

full_name: Charles-Edouard Luyt

given: Charles-Edouard

family: Tubach

full_name: Florence Tubach

given: Florence

family: Cracco

full_name: Christophe Cracco

given: Christophe

family: Alvarez

full_name: Antonio Alvarez

given: Antonio

family: Schwebel

full_name: Carole Schwebel

given: Carole

family: Schortgen

full_name: Frédérique Schortgen

given: Frédérique

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

family: Veber

full_name: Benoît Veber

given: Benoît

family: Dehoux

full_name: Monique Dehoux

given: Monique

family: Bernard

full_name: Maguy Bernard

given: Maguy

family: Pasquet

full_name: Blandine Pasquet

given: Blandine

family: Régnier

full_name: Bernard Régnier

given: Bernard

family: Brun-Buisson

full_name: Christian Brun-Buisson

given: Christian

family: Chastre

full_name: Jean Chastre

given: Jean

family: Wolff

full_name: Michel Wolff

given: Michel

journal_name: The Lancet


title: Assessment of Continuous Intravenous Insulin Protocol Versus Subcutaneous Insulin in Acute Ischemic Stroke

acronym: INSULINFARCT

summary: Hyperglycaemia is a frequent finding in acute ischemic stroke and associated with poor outcome. But the modalities of glucose lowering are still debated. This study will test the efficacy and safety of continuous intravenous insulin protocol versus usual subcutaneous insulin in acute ischemic stroke.

ReferenceCitation: Samson Y, Bruandet M, Lejeune M, Deltour S, Grimaldi A. [Insulin in the treatment of ischemic stroke]. Presse Med. 2006 Apr;35(4 Pt 2):696-8. Review. French.

ReferenceCitation: Rosso C, Pires C, Corvol JC, Baronnet F, Crozier S, Leger A, Deltour S, Valabregue R, Amor-Sahli M, Lehéricy S, Dormont D, Samson Y. Hyperglycaemia, insulin therapy and critical penumbral regions for prognosis in acute stroke: further insights from the INSULINFARCT trial. PLoS One. 2015 Mar 20;10(3):e0120230. doi: 10.1371/journal.pone.0120230. eCollection 2015.

family: Rosso

full_name: Charlotte Rosso

given: Charlotte

family: Pires

full_name: Christine Pires

given: Christine

family: Corvol

full_name: Jean-Christophe Corvol

given: Jean-Christophe

family: Baronnet

full_name: Flore Baronnet

given: Flore

family: Crozier

full_name: Sophie Crozier

given: Sophie

family: Leger

full_name: Anne Leger

given: Anne

family: Deltour

full_name: Sandrine Deltour

given: Sandrine

family: Valabregue

full_name: Romain Valabregue

given: Romain

family: Amor-Sahli

full_name: Mélika Amor-Sahli

given: Mélika

family: Lehéricy

full_name: Stéphane Lehéricy

given: Stéphane

family: Dormont

full_name: Didier Dormont

given: Didier

family: Samson

full_name: Yves Samson

given: Yves

journal_name: PLOS ONE

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_normalized: HAL

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

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

title: Hyperglycaemia, Insulin Therapy and Critical Penumbral Regions for Prognosis in Acute Stroke: Further Insights from the INSULINFARCT Trial

ReferenceCitation: Rosso C, Corvol JC, Pires C, Crozier S, Attal Y, Jacqueminet S, Deltour S, Multlu G, Leger A, Meresse I, Payan C, Dormont D, Samson Y. Intensive versus subcutaneous insulin in patients with hyperacute stroke: results from the randomized INSULINFARCT trial. Stroke. 2012 Sep;43(9):2343-9. doi: 10.1161/STROKEAHA.112.657122. Epub 2012 Jun 14.

name: From the AP-HP, Urgences Cérébro-Vasculaires, Pitié-Salpêtrière Hospital, Paris, France (C.R., C. Pires, S.C., S.D., G.M., A.L., I.M., Y.S.); UPMC, Univ Paris 06, Paris, France (C.R., J.-C.C., Y.A., D.D., Y.S.); COGIMAGE, Centre de Recherche de l'Institut du Cerveau et de la Moelle épinière, UPMC Paris 6, Inserm, U975, CNRS, UMR 7225, Paris, France (C.R., Y.A., D.D., Y.S.); AP-HP, Service de Neurologie Pharmacologie Clinique, Pitié-Salpêtrière Hospital, Paris, France (J.-C.C., C. Payan); Centre...

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Intensive Versus Subcutaneous Insulin in Patients With Hyperacute Stroke

location_facility: AP-HP Urgences cerebro vasculaires La Pitié Salpétrière


title: Assessment of a New Apexification Method for Patients Presenting a Non Vital Immature Tooth

acronym: APEXMTA

summary: Pulp necrosis is one of the main complication of dental trauma. When it happens on an immature tooth, pulp necrosis implies a lack of root maturation and apical closure. A therapy called apexification is required to induce the formation of a calcified apical barrier allowing a permanent and hermetic root filling.The aim of this study is to compare the efficacy of a new apexification method using Mineral Trioxide Aggregate (MTA®) with the reference treatment based on calcium hydroxide repeated stimulations.

ReferenceCitation: Beslot-Neveu A, Bonte E, Baune B, Serreau R, Aissat F, Quinquis L, Grabar S, Lasfargues JJ. Mineral trioxyde aggregate versus calcium hydroxide in apexification of non vital immature teeth: study protocol for a randomized controlled trial. Trials. 2011 Jul 13;12:174. doi: 10.1186/1745-6215-12-174.

family: Beslot-Neveu

full_name: Aurélie Beslot-Neveu

given: Aurélie

family: Bonte

full_name: Eric Bonte

given: Eric

family: Baune

full_name: Bruno Baune

given: Bruno

family: Serreau

full_name: Raphaël Serreau

given: Raphaël

family: Aissat

full_name: Fawzia Aissat

given: Fawzia

family: Quinquis

full_name: Laurent Quinquis

given: Laurent

family: Grabar

full_name: Sophie Grabar

family: Lasfargues

full_name: Jean-Jacques Lasfargues

given: Jean-Jacques

currency_apc_doaj: GBP

journal_name: Trials

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Mineral trioxyde aggregate versus calcium hydroxide in apexification of non vital immature teeth: Study protocol for a randomized controlled trial


title: Preoxygenation Using Noninvasive Ventilation Prior Intubation in Hypoxemic Patients

acronym: PREOXY

summary:
Critically ill patients are predisposed to oxyhaemoglobin desaturation during intubation. For the intubation of hypoxemic patients, preoxygenation using non invasive ventilation (NIV) is more effective at reducing arterial oxyhaemoglobin desaturation than standard method.

Objectives: To find out whether NIV, as a preoxygenation method, is more effective at reducing the degree of organ dysfunction/failure than standard preoxygenation during the week following endotracheal intubation.

primary_purpose: Prevention

ReferenceCitation: Baillard C, Fosse JP, Sebbane M, Chanques G, Vincent F, Courouble P, Cohen Y, Eledjam JJ, Adnet F, Jaber S. Noninvasive ventilation improves preoxygenation before intubation of hypoxic patients. Am J Respir Crit Care Med. 2006 Jul 15;174(2):171-7. Epub 2006 Apr 20.

ReferenceCitation: Baillard C, Prat G, Jung B, Futier E, Lefrant JY, Vincent F, Hamdi A, Vicaut E, Jaber S. Effect of preoxygenation using non-invasive ventilation before intubation on subsequent organ failures in hypoxaemic patients: a randomised clinical trial. Br J Anaesth. 2018 Feb;120(2):361-367. doi: 10.1016/j.bja.2017.11.067. Epub 2017 Nov 23.

family: Baillard

full_name: C. Baillard

given: C.

family: Prat

full_name: G. Prat

given: G.

family: Jung

full_name: B. Jung

given: B.

family: Futier

full_name: E. Futier

given: E.

family: Lefrant

full_name: J.Y. Lefrant

family: Vincent

full_name: F. Vincent

given: F.

family: Hamdi

full_name: A. Hamdi

given: A.

family: Vicaut

full_name: E. Vicaut

family: Jaber

full_name: S. Jaber

given: S.

journal_name: British Journal of Anaesthesia

oa_colors: green hybrid

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet


title: EVALUATION Of A NEW THERAPEUTIC STRATEGY FOR URETHRAL SPHINCTER INSUFFICIENCY BASED ON THE INTRA-URETHRAL IMPLANTATION OF AUTOLOGOUS MYOFIBERS WITH THEIR SATELLITE CELLS

summary: Stress urinary incontinence is a frequent condition that can be caused by urethral sphincter insufficiency and results in a dramatic deterioration of the quality of life. We developed a new therapeutic strategy for stress urinary incontinence based on the implantation myofibers with their satellite cells in the urethra. The aim of this procedure is to generate functional tissue acting like a new sphincter in the urethra

design_allocation: Non-Randomized


title: Arterial LIPIODOLISED Chemotherapy Versus Systemic Chemotherapy With Gemcitabine Plus Oxaliplatin (GEMOX) Versus no Treatment Following Surgical Resection or Local Ablation of Hepatocellular Carcinoma in Cirrhotic Patients

acronym: GEMOXIAL

summary: Besides liver transplantation, the curative treatment of primary hepatic cancer with cirrhosis remains the surgical resection. Radiofrequency or cryotherapy currently allow local ablation of small cancer, with very good results. However, all these treatments are followed by high rates of recurrence (50 - 70% at 5 years). Then, it seems essential to associate to the surgical resection or to the local ablation as "adjuvant" treatment, in order to prevent or to decrease the rate of recurrence. However, no evidence supports this attitude. Therefore, following curative treatment of primary hepatic cancer with cirrhosis, we propose to compare treated to untreated patients. Postoperative treatment means either intra-arterial chemotherapy or systemic chemotherapy. The main criterion of the study is time of survival without recurrence. The main secondary objective is the safety.

status: Terminated

status_simplified: Unknown


title: Randomised Trial of Eutectic Mixture of Local Anaesthetics Cream and Oral Sucrose Solution for Venepuncture in Preterm Infants

acronym: VIEP

summary: This randomized bicentric trial will investigate the efficacy of topical EMLA cream with oral sucrose solution compared to oral sucrose solution alone before venepuncture in preterm infants.

ReferenceCitation: Acharya AB, Annamali S, Taub NA, Field D. Oral sucrose analgesia for preterm infant venepuncture. Arch Dis Child Fetal Neonatal Ed. 2004 Jan;89(1):F17-8.

ReferenceCitation: Acharya AB, Bustani PC, Phillips JD, Taub NA, Beattie RM. Randomised controlled trial of eutectic mixture of local anaesthetics cream for venepuncture in healthy preterm infants. Arch Dis Child Fetal Neonatal Ed. 1998 Mar;78(2):F138-42.


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of VSF-173 and Matching Placebo in Healthy Male and Female Subjects With Induced Excessive Sleepiness

summary: The purpose of this study is to determine the safety and efficacy of VSF-173 compared to placebo in treatment of induced excessive sleepiness.

enrollment_type: Anticipated

lead_sponsor: Vanda Pharmaceuticals

lead_sponsor_type: industriel


title: Treatment of Myeloma in Patients <= 65 Years Old With Response >= 50% After HSC Autotransplant by Allogenic Transplant Genoidentical or Phenoidentical After Reduced Intensity Conditioning (IFM 2005-03)

summary:
Donor mobilization :

Donor will be mobilized with G-CSF (Granocyte) sub-cutaneous 10 µg/kg/day during 5 to 6 days.

Hematopoïetic Stem Cell Harvest:

By 1, 2, or 3 aphaeresis, a number of 4 x 106 cellules CD34+ /kg is required. If the CD34+ >= 2 and <= 4x106/kg: the center must decide on the strategy Decision. In case of insufficient graft : a Bone Marrow Harvest is recommended Conditioning : Fludarabine - Busulfan - ATG

D-5 : Fludarabine (30 mg/m²)
D-4 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h)
D-3 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h)
D-2 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg)
D-1 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg) GVHD Prophylaxis: CsA alone at 3 mg/ kg + Methotrexate D1, D3 and D6 only in case of minor ABO incompatibility and with an anti A/B antibodies titer> 1/32.

Transplant : HSC at D0

• 3 months after Transplantation :

Disease Evaluation :

If CR : Supervision. Then if progression: 4 cycles of Bortezomib.

If no CR : Bortezomib (4 cycles)

• Evaluation after Bortezomib cycles

If CR : Supervision. Then, if progression and no GvHD : DLI If no RC and no GVHD : DLI

ReferenceCitation: Michallet M, Sobh M, El-Cheikh J, Morisset S, Sirvent A, Reman O, Cornillon J, Tabrizi R, Milpied N, Harousseau JL, Labussière H, Nicolini FE, Attal M, Moreau P, Mohty M, Blaise D, Avet-Loiseau H. Evolving strategies with immunomodulating drugs and tandem autologous/allogeneic hematopoietic stem cell transplantation in first line high risk multiple myeloma patients. Exp Hematol. 2013 Dec;41(12):1008-15. doi: 10.1016/j.exphem.2013.08.003. Epub 2013 Aug 29.

family: Michallet

full_name: Mauricette Michallet

given: Mauricette

family: Sobh

full_name: Mohamad Sobh

given: Mohamad

family: El-Cheikh

full_name: Jean El-Cheikh

given: Jean

family: Morisset

full_name: Stéphane Morisset

given: Stéphane

family: Sirvent

full_name: Anne Sirvent

given: Anne

family: Reman

full_name: Oumedaly Reman

given: Oumedaly

family: Cornillon

full_name: Jérôme Cornillon

given: Jérôme

family: Tabrizi

full_name: Reza Tabrizi

given: Reza

family: Milpied

full_name: Noel Milpied

given: Noel

family: Harousseau

full_name: Jean-Luc Harousseau

given: Jean-Luc

family: Labussière

full_name: Hélène Labussière

given: Hélène

family: Nicolini

full_name: Franck-Emmanuel Nicolini

given: Franck-Emmanuel

family: Attal

full_name: Michel Attal

given: Michel

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Mohty

full_name: Mohamad Mohty

family: Blaise

full_name: Didier Blaise

family: Avet-Loiseau

full_name: Hérvé Avet-Loiseau

given: Hérvé

journal_name: Experimental Hematology

lead_sponsor: Hospices Civils de Lyon


title: Screening for Placental Insufficiency by a Combination of Second Trimester Uterine Artery Doppler and Maternal Serum Leptin and Lipids

acronym: ARTULEP

summary: To assess the role of uterine artery and maternal serum leptin and lipids and their combination in screening for pre-eclampsia and small-for-gestational-age (SGA) fetuses at 20-24 weeks of gestation

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Papageorghiou AT, Leslie K. Uterine artery Doppler in the prediction of adverse pregnancy outcome. Curr Opin Obstet Gynecol. 2007 Apr;19(2):103-9. Review.

ReferenceCitation: Guven MA, Ertas IE, Kilinc M, Coskun A, Ekerbicer H. Combining mid-trimester maternal plasma homocysteine with uterine artery doppler velocimetry: is it useful? Arch Gynecol Obstet. 2007 Jun;275(6):439-43. Epub 2006 Nov 17.

ReferenceCitation: Spencer K, Yu CK, Savvidou M, Papageorghiou AT, Nicolaides KH. Prediction of pre-eclampsia by uterine artery Doppler ultrasonography and maternal serum pregnancy-associated plasma protein-A, free beta-human chorionic gonadotropin, activin A and inhibin A at 22 + 0 to 24 + 6 weeks' gestation. Ultrasound Obstet Gynecol. 2006 Jun;27(6):658-63.

ReferenceCitation: Tommaselli GA, Pighetti M, Nasti A, D'Elia A, Guida M, Di Carlo C, Bifulco G, Nappi C. Serum leptin levels and uterine Doppler flow velocimetry at 20 weeks' gestation as markers for the development of pre-eclampsia. Gynecol Endocrinol. 2004 Sep;19(3):160-5.

lead_sponsor: University Hospital, Tours

location_facility: Olympe de Gouges Women Health Centre, Bretonneau University Hospital


title: Reduction of the Traumatic Memory by Reconsolidation Blockade: A Pilot Study

acronym: Reductrauma

summary:
Problem and Objectives: There is currently no pharmacological treatment for curing post traumatic stress disorder (PTSD). The investigators will test whether propranolol when given immediately after trauma evocation is able to decrease the strength of the traumatic memory, and by extension, the severity of PTSD symptoms associated with that memory.

Hypotheses:

The subjects will show a significant pre/post decrease in PTSD symptoms.
Those gains will be maintained at follow-up.

Study Design: Open pharmacological trial.

Method: On the first visit (V1), the subjects will describe their traumatic experience in writing and will receive the propranolol. A script describing this experience will be constructed to be used in the subsequent encounters to elicit the trauma memory. A week later (V2), before receiving the propranolol, subjects will be asked to read aloud their trauma script while imagining it as vividly as possible for 10 minutes. This weekly treatment will be repeated 6 times (from V1 to V6). A total of 6 doses of propranolol will be given. A self-report measure will be used to monitor improvement in PTSD symptomatology on the following visits: V1, V4, V6, V7 and V8 (3 month follow-up).

Statistical Analyses: A repeated measure ANOVA (pre-test, post-test, and 3-month follow-up) using the PTSD symptom score will be conducted.. Three t-tests will be performed to examine simple effects. The alpha level will be set at p = .05 (two-tailed). Fisher's exact test will be used to examine whether Ss still meet the diagnostic criteria for PTSD at the end of the study.

Clinical Implications: If this treatment is effective, a randomized controlled trial will be launched. This treatment has the potential to become the first pharmacological treatment designed to cure PTSD.

ReferenceCitation: Pitman RK, Sanders KM, Zusman RM, Healy AR, Cheema F, Lasko NB, Cahill L, Orr SP. Pilot study of secondary prevention of posttraumatic stress disorder with propranolol. Biol Psychiatry. 2002 Jan 15;51(2):189-92.

ReferenceCitation: Vaiva G, Ducrocq F, Jezequel K, Averland B, Lestavel P, Brunet A, Marmar CR. Immediate treatment with propranolol decreases posttraumatic stress disorder two months after trauma. Biol Psychiatry. 2003 Nov 1;54(9):947-9. Erratum in: Biol Psychiatry. 2003 Dec 15;54(12):1471.

lead_sponsor: University Hospital, Toulouse


title: B14 Meningococcal Carriage in Seine-Maritime Population: Prevalence Study and Search of Risk Factors

summary: Our main objectives are to evaluate the importance of meningococcal carriage and to determine the predisposing factors

lead_sponsor: University Hospital, Rouen


title: Study Evaluating the Contribution of MRI for the Evaluation of Early Response to Neoadjuvant Chemotherapy in Patients With Infiltrative Breast Cancer

summary:
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help in learning how well chemotherapy works to kill breast cancer cells and allow doctors to plan better treatment. Drugs used in chemotherapy, such as epirubicin and docetaxel, may stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This clinical trial is studying MRI in evaluating early response to chemotherapy in women receiving chemotherapy for infiltrating breast cancer.

lead_sponsor: Institut Bergonié


title: Pilot Clinical Trial of Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation in Adult Patients With Multiple Myeloma in First Response

acronym: Expansion

summary: Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after injection of ex vivo amplified graft and by a platelets number > 20000/mm3, at day 15 after the injection of ex vivo amplified graft, without transfusion.

ReferenceCitation: Bernstein ID, Andrews RG, Zsebo KM. Recombinant human stem cell factor enhances the formation of colonies by CD34+ and CD34+lin- cells, and the generation of colony-forming cell progeny from CD34+lin- cells cultured with interleukin-3, granulocyte colony-stimulating factor, or granulocyte-macrophage colony-stimulating factor. Blood. 1991 Jun 1;77(11):2316-21.

ReferenceCitation: Bodine DM, Crosier PS, Clark SC. Effects of hematopoietic growth factors on the survival of primitive stem cells in liquid suspension culture. Blood. 1991 Aug 15;78(4):914-20.

ReferenceCitation: Boiron JM, Marit G, Fabéres C, Cony-Makhoul P, Foures C, Ferrer AM, Cristol G, Sarrat A, Girault D, Reiffers J. Collection of peripheral blood stem cells in multiple myeloma following single high-dose cyclophosphamide with and without recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF). Bone Marrow Transplant. 1993 Jul;12(1):49-55.

ReferenceCitation: Brandt J, Srour EF, van Besien K, Briddell RA, Hoffman R. Cytokine-dependent long-term culture of highly enriched precursors of hematopoietic progenitor cells from human bone marrow. J Clin Invest. 1990 Sep;86(3):932-41.

ReferenceCitation: Brugger W, Heimfeld S, Berenson RJ, Mertelsmann R, Kanz L. Reconstitution of hematopoiesis after high-dose chemotherapy by autologous progenitor cells generated ex vivo. N Engl J Med. 1995 Aug 3;333(5):283-7. Retraction in: Kanz L, Brugger W. N Engl J Med. 2001 Jul 5;345(1):64.

ReferenceCitation: Haylock DN, To LB, Dowse TL, Juttner CA, Simmons PJ. Ex vivo expansion and maturation of peripheral blood CD34+ cells into the myeloid lineage. Blood. 1992 Sep 15;80(6):1405-12.

ReferenceCitation: Iscove NN, Shaw AR, Keller G. Net increase of pluripotential hematopoietic precursors in suspension culture in response to IL-1 and IL-3. J Immunol. 1989 Apr 1;142(7):2332-7.

ReferenceCitation: Ivanovic Z, Duchez P, Dazey B, Hermitte F, Lamrissi-Garcia I, Mazurier F, Praloran V, Reiffers J, Vezon G, Boiron JM. A clinical-scale expansion of mobilized CD 34+ hematopoietic stem and progenitor cells by use of a new serum-free medium. Transfusion. 2006 Jan;46(1):126-31.

ReferenceCitation: Kobayashi M, Imamura M, Gotohda Y, Maeda S, Iwasaki H, Sakurada K, Kasai M, Hapel AJ, Miyazaki T. Synergistic effects of interleukin-1 beta and interleukin-3 on the expansion of human hematopoietic progenitor cells in liquid cultures. Blood. 1991 Oct 15;78(8):1947-53.

ReferenceCitation: Moore MA. Review: Stratton Lecture 1990. Clinical implications of positive and negative hematopoietic stem cell regulators. Blood. 1991 Jul 1;78(1):1-19. Review.

ReferenceCitation: Moore MA. Hematopoietic reconstruction: new approaches. Clin Cancer Res. 1995 Jan;1(1):3-9. Review.

ReferenceCitation: Muench MO, Moore MA. Accelerated recovery of peripheral blood cell counts in mice transplanted with in vitro cytokine-expanded hematopoietic progenitors. Exp Hematol. 1992 Jun;20(5):611-8.

ReferenceCitation: Muench MO, Schneider JG, Moore MA. Interactions among colony-stimulating factors, IL-1 beta, IL-6, and kit-ligand in the regulation of primitive murine hematopoietic cells. Exp Hematol. 1992 Mar;20(3):339-49.

ReferenceCitation: Reiffers J, Marit G, Vezon G, Cony-Makhoul P, Boiron JM, Montastruc M, Rice A, Broustet A. Autologous blood stem cell grafting in hematological malignancies. Present status and future directions. Transfus Sci. 1992;13(4):399-405. Review.

ReferenceCitation: Reiffers J, Faberes C, Boiron JM, Marit G, Foures C, Ferrer AM, Cony-Makhoul P, Puntous M, Bernard P, Vezon G, et al. Peripheral blood progenitor cell transplantation in 118 patients with hematological malignancies: analysis of factors affecting the rate of engraftment. J Hematother. 1994 Fall;3(3):185-91.

ReferenceCitation: Rice A, Boiron JM, Barbot C, Dupouy M, Dubsoc-Marchenay N, Dumain P, Lacombe F, Reiffers J. Cytokine-mediated expansion of 5-FU resistant peripheral blood stem cells and bone marrow: self-renewal and commitment capacity. J Hematother. 1994 Summer;3(2):135-9.

ReferenceCitation: Shih JP, Ogawa M. Monoclonal antibody J11d.2 recognizes cell cycle-dormant, primitive hematopoietic progenitors of mice. Blood. 1993 Mar 1;81(5):1155-60.

ReferenceCitation: Smith C, Gasparetto C, Collins N, Gillio A, Muench MO, O'Reilly RJ, Moore MA. Purification and partial characterization of a human hematopoietic precursor population. Blood. 1991 May 15;77(10):2122-8.

lead_sponsor: University Hospital, Bordeaux


summary:
Methicillin resistant Staphylococcus aureus (MRSA) which is one of the principal multidrug resistant organisms found in the hospitals all over the world, has recently emerged in the community. However, for the moment (2002), the hospital remains the principal reservoir of MRSA so far and the patients discharged with a MRSA carriage can be the source of MRSA spreading in the community. In particular patients admitted to home care (HC) from acute care facilities represent a patient group with a high risk of MRSA carriage and of being the source of MRSA spreading in the community. The objective of this study is to determine whether HC patients are effectively a MRSA reservoir and a source for MRSA spreading in the community.

For that, from February 2003 to March 2004 any adult patient (except obstetric patient) (approximately 3360 patients for 16 HC settings), will be screened [nasal and skin lesion (if any) swabs] for MRSA carriage within the 48 h before his/her transfer. The patients found to be MRSA carriers will be visited by a physician who will ask patients as well as family members to participate in the study. Each patient and each family member who will have given agreement to participate, will be sampled (nasal swab for both patient and family members, and skin lesion swab for the patients with skin lesions) every month for 12 months by the nurse of the HC setting in which the patient will have been admitted. As soon as the patient will be discharged from HC setting and if the 12 month survey is not finished, patient and family member swab sampling will be performed by the nurse of the research team (NRT) every 3 months until the end of the survey period. These swabs will be transmitted by the NRT to the research center and analyze by the microbial technician of the research center. The bacteriological survey will be accompanied with an epidemiological survey in order to determine the risk factors for a long term MRSA carriage in the patients admitted in HC and also the risk factors for transmitting MRSA to their family.

This multi-centre and multi-investigator study will be performed over a period of 32 months (1 month to prepare the study, 13 months to screen patients with regard to MRSA carriage before their transfer from acute care settings into HC settings, 12 months to survey HC patients and their family members and 6 months to analyze data and prepare publications). Such a study will provide us with descriptive and quantitative data on MRSA strains introduced in the community by HC patients. From the analysis of risk factors of MRSA transmission from these patients to their family members, suggestions to limit this transmission might be drawn.

location_facility: Dpt Immuno-Microbiologie des Pathologies Infectieuses - Hôpital Beaujon


title: Profile of Hypertensive Patients Seen in General Practitioner Consultation

acronym: Prophyl GP

summary: To evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics, health care management) of hypertensive patients seen in general practitioner consultation.

lead_sponsor: AstraZeneca


title: Chevron Osteotomy Versus SCARF Osteotomy in the Treatment of Hallux Valgus

summary:
Comparison between two techniques of osteotomy wich are more or less invasive : two criterias : clinical data and x-rays data.

All patients operated for hallux valgus for 01/01/99 to 31/12/03 in the department of bone surgery CHU Limoges :

Scarf or Jonhson (chevron) osteotomy
Experienced surgeon : Pr ARNAUD, Pr MABIT or Pr CHARISSOUX.

lead_sponsor: University Hospital, Limoges


title: Evaluation of the Effects of Post-Immediate Psychotherapeutic Interventions in Secondary Prevention of Psychotraumatic Disorders

acronym: IPPI A

summary:
Argumentation The frequency of post-traumatic syndrome disorder (PTSD) is estimated around 1% of the entire European population. In some specific populations, this percentage increases (soldiers - 15 to 22%, war or persecuted refugees - 80%, post office or bank employees submitted to an hold-up - 17%, firemen - 10 to 30%, emergency care employees - 11%, people who underwent a terrorist attack or any violence - 20 to 65%...)

Prevention is yet poor, secondary prevention trying to avoid a post traumatic disorder apparition early after the traumatic event. There is currently two types of secondary prevention :

Mitchell's debriefing based upon stress and its theories, using cognitive and behavioural approaches
French debriefing (post-immediate psychotherapeutic intervention) based on the traumatism, never realised before second day post event and applied by mental health professionals.

The current controversy of the Mitchell's debriefing leads us to evaluate the post-immediate psychotherapeutic intervention, never evaluated yet.

Scientific Objectives Primary objective: To verify that post-immediate psychotherapeutic interventions (proposed after 2 days and before the end of first month post event) decrease incidence, duration and intensity of psychotraumatic disorders at one year, versus a control group.

Secondary objectives :

To document the efficacy of these interventions regarding professional, social and familial adaptation.
To identify predictive factors of response to this strategy.

Method Experimental Design National multicentered, randomized, single blind study Study Population 330 men or women aged 18 to 65, subjected to a potentially traumatic event (criteria A1, DSM IV) and having presented an emotional reaction (intense fear, impotency or horror, criteria A2, DSM IV). This event must have happened within 8 days prior randomization. Patients treated with βblockers and patients suffering from psychopathologic disorders won't be considered for the study.

Outcome measures Primary outcome: PTSD frequency (on the basis of questionnaire CAPS).

Secondary outcome:

Complete and subsyndormic PTSD occurence (CAPS),
Intensity of psychotraumatic disorders (Sheehan scale),
Psychopathologic disorder frequency (CIDI SF),
Evolution of anxiety/depression (HAD scale),
Alcoholization frequency (CAGE scale),
Frequency of somatic adverse events,
Access to health care (number and types of contacts).

Expected benefits The post-immediate psychotherapeutic intervention shall avoid psychological disorders apparition or improve its symptoms. This would decrease consequences on personal life (social, relational and professional).

The study results will allow a better knowledge of these post traumatic disorders.

status: Unknown status

study_completion_date_type: Anticipated

lead_sponsor: Groupe Francais d'Epidemiologie Psychiatrique


type: Other Identifier

title: RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY / BREVITY-02 in Germany)

acronym: BREVITY

summary: The current study aims to provide validation results of RNA Disruption Assay (RDA) as a tumour response assessment tool that uses tumour core biopsies taken starting from 35 +/- 4 days after the initiation of neoadjuvant chemotherapy.

study_start_date_type: Actual

status: Recruiting

ReferenceCitation: Parissenti AM, Guo B, Pritzker LB, Pritzker KP, Wang X, Zhu M, Shepherd LE, Trudeau ME. Tumor RNA disruption predicts survival benefit from breast cancer chemotherapy. Breast Cancer Res Treat. 2015 Aug;153(1):135-44. doi: 10.1007/s10549-015-3498-9. Epub 2015 Jul 25.

ReferenceCitation: Narendrula R, Mispel-Beyer K, Guo B, Parissenti AM, Pritzker LB, Pritzker K, Masilamani T, Wang X, Lannér C. RNA disruption is associated with response to multiple classes of chemotherapy drugs in tumor cell lines. BMC Cancer. 2016 Feb 24;16:146. doi: 10.1186/s12885-016-2197-1.

ReferenceCitation: Toomey S, Eustace AJ, Pritzker LB, Pritzker KP, Fay J, O'Grady A, Cummins R, Grogan L, Kennedy J, O'Connor D, Young L, Kay EW, O'Donovan N, Gallagher WM, Kalachand R, Crown J, Hennessy BT. RE: RNA Disruption Assay as a Biomarker of Pathological Complete Response in Neoadjuvant Trastuzumab-Treated Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. J Natl Cancer Inst. 2016 Jul 4;108(8). pii: djw111. doi: 10.1093/jnci/djw111. Print 2016 Aug.

ReferenceCitation: Pritzker K, Pritzker L, Generali D, Bottini A, Cappelletti MR, Guo B, Parissenti A, Trudeau M. RNA Disruption and Drug Response in Breast Cancer Primary Systemic Therapy. J Natl Cancer Inst Monogr. 2015 May;2015(51):76-80. doi: 10.1093/jncimonographs/lgv015.

ReferenceCitation: von Minckwitz G, Blohmer JU, Costa SD, Denkert C, Eidtmann H, Eiermann W, Gerber B, Hanusch C, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Kümmel S, Paepke S, Schneeweiss A, Untch M, Zahm DM, Mehta K, Loibl S. Response-guided neoadjuvant chemotherapy for breast cancer. J Clin Oncol. 2013 Oct 10;31(29):3623-30. doi: 10.1200/JCO.2012.45.0940. Epub 2013 Sep 3.

ReferenceCitation: Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Swain SM, Prowell T, Loibl S, Wickerham DL, Bogaerts J, Baselga J, Perou C, Blumenthal G, Blohmer J, Mamounas EP, Bergh J, Semiglazov V, Justice R, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching PA, Slaets L, Tang S, Gerber B, Geyer CE Jr, Pazdur R, Ditsch N, Rastogi P, Eiermann W, von Minckwitz G. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014 Jul 12;384(9938):164-72. doi: 10.1016/S0140-6736(13)62422-8. Epub 2014 Feb 14. Review. Erratum in: Lancet. 2019 Mar 9;393(10175):986.

ipd_sharing: No

lead_sponsor: Rna Diagnostics Inc.

location_country:
Italy
United States
Canada
France

location_facility: SST di Cremona Multidisciplinare di Patologia Mammaria, Italy

status_simplified: Ongoing


title: Double Blind Placebo Controlled Study to Assess the Expression of IgE on Basophils and Dendritic Cells During Omalizumab Treatment.

summary: The aim of this study is to evaluate the expression of IgE high affinity receptors (the part of the cell associated with allergic response) in patients suffering from uncontrolled severe asthma despite long term treatment with high dose of inhaled corticosteroid and long acting Beta-2 agonist.

ReferenceCitation: Chanez P, Contin-Bordes C, Garcia G, Verkindre C, Didier A, De Blay F, de Lara MT, Blanco P, Moreau JF, Robinson P, Bourdeix I, Trunet P, Le Gros V, Humbert M, Molimard M. Omalizumab-induced decrease of FcξRI expression in patients with severe allergic asthma. Respir Med. 2010 Nov;104(11):1608-17. doi: 10.1016/j.rmed.2010.07.011. Epub 2010 Aug 30.

family: Chanez

full_name: Pascal Chanez

given: Pascal

family: Contin-Bordes

full_name: Cécile Contin-Bordes

given: Cécile

family: Garcia

full_name: Gilles Garcia

given: Gilles

family: Verkindre

full_name: Christophe Verkindre

given: Christophe

family: Didier

full_name: Alain Didier

given: Alain

family: De Blay

full_name: Frédéric De Blay

given: Frédéric

family: Tunon de Lara

full_name: Manuel Tunon de Lara

given: Manuel

family: Blanco

full_name: Patrick Blanco

given: Patrick

full_name: Jean-François Moreau

given: Jean-François

family: Robinson

full_name: Philip Robinson

given: Philip

family: Bourdeix

full_name: Isabelle Bourdeix

given: Isabelle

family: Trunet

full_name: Patrick Trunet

family: Le Gros

full_name: Vincent Le Gros

given: Vincent

family: Humbert

full_name: Marc Humbert

given: Marc

family: Molimard

full_name: Mathieu Molimard

given: Mathieu

journal_name: Respiratory Medicine

oa_host_type: publisher

title: Omalizumab-induced decrease of FcɛRI expression in patients with severe allergic asthma

lead_sponsor: Novartis Pharmaceuticals


title: Screening of Fibrosing and/or Viral Chronic Hepatopathies in Jail

summary: The prevalence of chronic hepatopathies is high in jail. However, the medical care of these hepatopathies is few developed. This study is an observational, an epidemiologic (screening and prevalence of fibrosing hepatopathies) and an evaluating study for a better taking care of these hepatopathies in jail. The aims of the study will be to evaluate the diagnostic performance of the FibroMeter score in the screening of the hepatic fibrosis in persons with multiple risk factors for liver fibrosis (alcoholism, intravenous drug users, tattoo, and virological status) with FibroScan® as gold standard; to evaluate the feasibility of these different screening tools for chronic hepatopathies in jail and to evaluate the prevalence of the fibrosing hepatopathies with clinically significant fibrosis and theirs risk factors, alcohol and hepatitis B and hepatitis C viruses in population from Angers jail.

lead_sponsor: University Hospital, Angers

intervention_type: Other


title: A Phase IIIb, Prospective, Interventional, Multicentre, 3-year Study to Explore the Long-term Evolution of Sign and Symptoms, and Occurence of Complications in Dry Eye Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin)

summary: The proposed 36-month Post Approval Efficacy Study (PAES) is a prospective, interventional, multicentre study to explore the long-term evolution of signs and symptoms, and occurrence of complications in Dry Eye Disease (DED) patients with severe keratitis receiving Ikervis® (1mg/mL ciclosporin) eye drops administered once daily

lead_sponsor: Santen SAS

location_country:
Italy
France
Czechia
Poland
Russian Federation
Spain
Turkey

location_facility: Hopitaux Universitaires Paris-Sud - Hopital Bicetre

location_facility: First Saint Petersburg State Medical University named after academician I.P. Pavlov

location_facility: Universita degli Studi di Milano - Clinica Oculistica I

location_facility: State Budget Educational Institution of High Professional Education Moscow State Medical Stomatology University named after A.I.Evdokimov of MoH of RF

location_facility: Fakultni Nemocnice Ostrava, Oční Klinika

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Oko-Laser

location_facility: Saint Petersburg State Pediatric Medical University

location_facility: Selcuk University School of Medicine Ophthalmology department

location_facility: NMRC ISTC Eye Microsurgery n. a. Fyodorov - Moscow

location_facility: Bayındır Kavaklidere Hospital Ophthalmology department

location_facility: Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo - Clinica Oculistic

location_facility: Polo Universita degli Studi di Milano - Ospedale Luigi Sacco - Clinica Oculistica (Eye Clinic)

location_facility: Federal State Institution Intersectoral Research and Technology Complex Eye microsurgery n.a. academician S.N. Fyodorov - Cheboksary

location_facility: Fundación Oftalmológica del Mediterráneo

location_facility: Hospital Clinico Universitario Lozano Blesa de Zaragoza

location_facility: Ege Universitesi Tip Fakultesi Hastanesi Goz Hastaliklari Anabilim Dali

location_facility: Azienda Ospedaliera Universitaria Policlinico Gaetano Martino - Messina

location_facility: Universita degli Studi di Milano - Ospedale San Giuseppe - Clinica Oculistica (University Eye Clinic)

location_facility: Hopitaux Universitaires Paris Nord Val de Seine - Hopital Bichat - Claude Bernard

location_facility: Hospices Civils de Lyon - Hopital de la Croix-Rousse

location_facility: GBOU VPO Omsk State Medical Academy, Ophthalmology Department

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 Klinika Diagnostyki i Mikrochirurgii Jaskry Oddział Okulistyki

location_facility: FSBI The Academician S.N. Fyodorov IRTC Eye Microsurgery of the Minzdrava - Novosibirsk

location_facility: Uniwersytecki Szpital Kiliniczny IM. Jana Milkulicza-Radeckiego we Wroclawiu

location_facility: Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Oculistica

location_facility: Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

location_facility: Ankara Üniversitesi Tıp Fakültesi Göz Hastalıkları Anabilim Dalı Vehbi Koç Göz Hastanesi

location_facility: ASST Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario - Clinica Oculistica III

location_facility: Hospital Universitario Donostia, Oftalmalogia

location_facility: Uniwersyteckie Centrum Kliniczne Śląskiego Uniwersytetu Medycznego w Katowicach

location_facility: Gabinet Okulistyczny Prof. Edward Wylęgała


title: Evaluation of Environmental Stress and Individualized Sensorimotor Care on Autonomic Nervous System Activity in a Premature Population : a Prospective Study

summary:
Autonomic nervous system (ANS) is an essential regulator for the homeostasis, circulatory and respiratory systems. Heart rate variability, under the dependence of the parasympathetic and orthosympathetic arms is a peripheral witness of its well functioning.

Activity ANS indices are technically measurable from the birth by non invasive cardiac monitoring: in given environmental conditions. According to the individualized care given to the baby, we can easily observe by frequential analysis, modifications of ANS level activity; If for a full-term newborn, the balance of ANS allows him to adapt its cardiac frequency to its internal and external environment (thermoregulation, baroreflex, sinus arrhythmia, awakening state) , the premature birth is at the origin of a prolonged defect of global ANS maturation, probably induced by external environmental and stress factors (pain, stimulations, aggressive noise and lights). This disrupted maturation profile in case of prematurity, was confirmed in two preliminary studies on premature babies reaching term for gestational age.

We hypothesis that adapted sensorimotor care could decrease this stress and optimize the ANS activity profile.

In a prospective study, by a non invasive real-time measure, we analyse impact of stress on ANS activity in a premature population, hospitalized in our neonatal intensive care units.

ReferenceCitation: Patural H, Barthelemy JC, Pichot V, Mazzocchi C, Teyssier G, Damon G, Roche F. Birth prematurity determines prolonged autonomic nervous system immaturity. Clin Auton Res. 2004 Dec;14(6):391-5.

ReferenceCitation: Patural H, Pichot V, Jaziri F, Teyssier G, Gaspoz JM, Roche F, Barthelemy JC. Autonomic cardiac control of very preterm newborns: a prolonged dysfunction. Early Hum Dev. 2008 Oct;84(10):681-7. doi: 10.1016/j.earlhumdev.2008.04.010. Epub 2008 Jun 16.

family: Patural

full_name: Hugues Patural

given: Hugues

family: Pichot

full_name: Vincent Pichot

family: Jaziri

full_name: Fethi Jaziri

given: Fethi

family: Teyssier

full_name: Georges Teyssier

given: Georges

family: Gaspoz

full_name: Jean-Michel Gaspoz

given: Jean-Michel

family: Roche

full_name: Frédéric Roche

family: Barthelemy

full_name: Jean-Claude Barthelemy

given: Jean-Claude

journal_name: Early Human Development

title: Autonomic cardiac control of very preterm newborns: A prolonged dysfunction


title: CONSTITUTION D'UNE BIOTHEQUE DE PATIENTS DE SEINE-MARITIME AUX ANTECEDENTS D'INFECTION INVASIVE A MENINGOCOQUES

summary: The main objective of this study is to constitute a biotheque of patients with meningococcal disease to enable results to be interpreted and genetic factors to be determined


title: EVALUATION DE LA REPONSE IMMUNITAIRE CONTRE LA SOUCHE DE NEISSERIA MENINGITIDIS B:14,P1.7,16

summary: The main objective of the study is to estimate the proportion of children, born between the 01/01/2002 and the 06/23/200, living around Dieppe (cantons Dieppe est, Dieppe Ouest and Offranville), vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4), before and after the third MenBvac vaccination.


title: COVID-19 and Rare Skin Diseases. European Observational Study (Data Research) During an Epidemic

summary: This is a European observational cohort study (data research) involving multiple centres to look at the potential impact of COVID infection on patients with rare skin diseases examining factors such as comorbidity, protection factors, and clinical and/or therapeutic factors. The data collected may provide additional information on the situation of patients and, on a wider basis, provide useful data applicable to the general population.

time_perspective: Other

lead_sponsor: Imagine Institute

location_country: Italy France Czechia Lithuania Germany

location_facility: Hôpital Necker - Enfants malades (AP-HP)

location_facility: University Hospital of Erlangen - ZSEER - Zentrum für Seltene Erkrankungen Erlangen

location_facility: University Hospital Brno - EB Centrum CR Dermatolog

location_facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos

location_facility: Städtisches Klinikum Dessau, Dessau Medical Center


type: EudraCT Number

title: Assessment of Two Modes of Premedication in Surgery - PREMED Study

acronym: PREMED

summary:
The purpose of this study is to test the level of anxiety in patients, the day before surgery (late afternoon) and immediately prior to surgery in 3 parallel groups of patients.

one receiving placebo before going to sleep (before sleep), the day prior surgery and placebo when awakening (awakening), the day of surgery
one receiving zopiclone (7.5 mg) before sleep and placebo at awakening
one receiving placebo before sleep and alprazolam (0.5 mg)at awakening

double blind, randomized controlled study

ReferenceCitation: Beydon L, Rouxel A, Camut N, Schinkel N, Malinovsky JM, Aveline C, Marret E, Bildea A, Dupoiron D, Liu N, Daniel V, Darsonval A, Chrétien JM, Rault L, Bruna J, Alberti C. Sedative premedication before surgery--A multicentre randomized study versus placebo. Anaesth Crit Care Pain Med. 2015 Jun;34(3):165-71. doi: 10.1016/j.accpm.2015.01.005. Epub 2015 May 23.

family: Beydon

full_name: Laurent Beydon

given: Laurent

family: Rouxel

full_name: Adrien Rouxel

given: Adrien

family: Camut

full_name: Nicolas Camut

given: Nicolas

family: Schinkel

full_name: Naren Schinkel

given: Naren

family: Malinovsky

full_name: Jean-Marc Malinovsky

given: Jean-Marc

family: Aveline

full_name: Christophe Aveline

family: Marret

full_name: Emmanuel Marret

given: Emmanuel

family: Bildea

full_name: Adriana Bildea

given: Adriana

family: Dupoiron

full_name: Denis Dupoiron

given: Denis

family: Liu

full_name: Ngai Liu

given: Ngai

family: Daniel

full_name: Valérie Daniel

given: Valérie

family: Darsonval

full_name: Astrid Darsonval

given: Astrid

family: Chrétien

full_name: Jean-Marie Chrétien

given: Jean-Marie

family: Rault

full_name: Laetitia Rault

given: Laetitia

family: Bruna

full_name: Jacques Bruna

given: Jacques

family: Alberti

full_name: Corinne Alberti

given: Corinne

bso_classification: Chemistry

journal_name: Anaesthesia Critical Care & Pain Medicine

title: Sedative premedication before surgery – A multicentre randomized study versus placebo

location_facility: Dept of Anesthesia, Hôpital Maison Blanche


title: Pharmacokinetics Variability of Ceftriaxone in Septic ICU Patients

acronym: PORTHOS

summary:
Ceftriaxone pharmacokinetics variability in intensive care unit septic patients

In intensive care units, drug dosage is often based on study made on healthy volunteers or on less severe patients.

However, pharmacokinetic alterations have been described for some drugs used in intensive care units.

These alterations, consequences of alteration of volume of distribution, of protein concentrations, of impaired hepatic and renal functions can result in accumulation with toxicity or " under dosage " with inefficacity.

Ceftriaxone is an antibiotic often prescribed in intensive care unit. However, despite this large utilisation, very few data is available on the pharmacokinetic in intensive care unit, and optimal dosage is not known.

Our objective is to develop a population pharmacokinetics model of ceftriaxone in intensive care unit patients with sepsis, severe sepsis and septic shock and to identify the " data " explaining interindividual variability of each pharmacokinetics parameter.

ReferenceCitation: Garot D, Respaud R, Lanotte P, Simon N, Mercier E, Ehrmann S, Perrotin D, Dequin PF, Le Guellec C. Population pharmacokinetics of ceftriaxone in critically ill septic patients: a reappraisal. Br J Clin Pharmacol. 2011 Nov;72(5):758-67. doi: 10.1111/j.1365-2125.2011.04005.x.

family: Garot

full_name: Denis Garot

family: Respaud

full_name: Renaud Respaud

given: Renaud

family: Lanotte

full_name: Philippe Lanotte

given: Philippe

family: Simon

full_name: Nicolas Simon

family: Mercier

full_name: Emmanuelle Mercier

given: Emmanuelle

family: Ehrmann

full_name: Stephan Ehrmann

given: Stephan

family: Perrotin

full_name: Dominique Perrotin

given: Dominique

family: Dequin

full_name: Pierre-François Dequin

given: Pierre-François

family: Le Guellec

full_name: Chantal Le Guellec

given: Chantal

journal_name: British Journal of Clinical Pharmacology

lead_sponsor: Association Pour La Promotion A Tours De La Reanimation Medicale

location_facility: Cenrte Hospitalier Régional Universitaire


title: Evaluation of Preoperative Education and Mini-invasive Total Hip Replacement in Regard to the Attainment of Functional Independency and Reduction of Hospital Stay

acronym: ANRACT

summary:
We propose to evaluate a preoperative education of the patient and a new surgical technique (the mini-invasive THR) that could reduce the time to achieve functional independence.

The primary objective of the trial is to assess the time to reach functional independence after total hip replacement depending on the treatment groups: preoperative education versus no preoperative education and mini-invasive procedure versus standard procedure. The study hypothesis is that education and mini-invasive procedure will reduce the time to reach functional independence.

This is a prospective trial with a double randomization.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Equimolar Doses of Mannitol and Hypertonic Saline in the Treatment of Elevated Intracranial Pressure

summary: The purpose of this study is to determine whether mannitol is as effective as hypertonic saline solution in the treatment of elevated intracranial pressure in patients with brain injury.

ReferenceCitation: Battison C, Andrews PJ, Graham C, Petty T. Randomized, controlled trial on the effect of a 20% mannitol solution and a 7.5% saline/6% dextran solution on increased intracranial pressure after brain injury. Crit Care Med. 2005 Jan;33(1):196-202; discussion 257-8.

ReferenceCitation: Vialet R, Albanèse J, Thomachot L, Antonini F, Bourgouin A, Alliez B, Martin C. Isovolume hypertonic solutes (sodium chloride or mannitol) in the treatment of refractory posttraumatic intracranial hypertension: 2 mL/kg 7.5% saline is more effective than 2 mL/kg 20% mannitol. Crit Care Med. 2003 Jun;31(6):1683-7.

lead_sponsor: University Hospital, Grenoble


title: Study of Interaction Between Adipose and Muscle Tissues in the Control of Muscle Mitochondrial Functions

acronym: Mithycal

summary:
Numerous studies have demonstrated that excess perivisceral adipose tissue is associated with metabolic diseases such as insulin resistance.

In skeletal muscle, insulin resistance has been correlated with reduced mitochondrial oxidative functions. According to the actual theory, mitochondrial dysfunctions are proposed to play a causal role in the aetiology of insulin resistance. Mechanisms involve increased intramyocellular lipids storage. Yet, the causes responsible for the decline in muscle mitochondrial functions remain to be elucidated.

The investigators hypothesize that these alterations are induced by combined changes in plasma profiles of lipids and adipokines, which originate from perivisceral adipose tissue. The study aims at answering the following questions :

Are muscle mitochondrial functions altered in association with increased perivisceral adipose tissue storage?
Do changes in the pattern of plasma lipids and adipokines explain this correlation?

ReferenceCitation: Chanséaume E, Tardy AL, Salles J, Giraudet C, Rousset P, Tissandier A, Boirie Y, Morio B. Chronological approach of diet-induced alterations in muscle mitochondrial functions in rats. Obesity (Silver Spring). 2007 Jan;15(1):50-9.

ReferenceCitation: Chanseaume E, Malpuech-Brugère C, Patrac V, Bielicki G, Rousset P, Couturier K, Salles J, Renou JP, Boirie Y, Morio B. Diets high in sugar, fat, and energy induce muscle type-specific adaptations in mitochondrial functions in rats. J Nutr. 2006 Aug;136(8):2194-200.

ReferenceCitation: Chanseaume E, Barquissau V, Salles J, Aucouturier J, Patrac V, Giraudet C, Gryson C, Duché P, Boirie Y, Chardigny JM, Morio B. Muscle mitochondrial oxidative phosphorylation activity, but not content, is altered with abdominal obesity in sedentary men: synergism with changes in insulin sensitivity. J Clin Endocrinol Metab. 2010 Jun;95(6):2948-56. doi: 10.1210/jc.2009-1938. Epub 2010 Apr 9.

family: Chanseaume

full_name: Emilie Chanseaume

given: Emilie

family: Barquissau

full_name: Valentin Barquissau

given: Valentin

family: Salles

full_name: Jérôme Salles

given: Jérôme

family: Aucouturier

full_name: Julien Aucouturier

given: Julien

family: Patrac

full_name: Véronique Patrac

given: Véronique

family: Giraudet

full_name: Christophe Giraudet

given: Christophe

family: Gryson

full_name: Céline Gryson

given: Céline

family: Duché

full_name: Pascale Duché

given: Pascale

family: Boirie

full_name: Yves Boirie

given: Yves

family: Chardigny

full_name: Jean-Michel Chardigny

given: Jean-Michel

family: Morio

full_name: Béatrice Morio

given: Béatrice

journal_name: The Journal of Clinical Endocrinology & Metabolism

evidence: open (via free pdf)

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

title: Muscle Mitochondrial Oxidative Phosphorylation Activity, But Not Content, Is Altered with Abdominal Obesity in Sedentary Men: Synergism with Changes in Insulin Sensitivity

lead_sponsor: Institut National de la Recherche Agronomique

location_facility: Centre ed Recherche en Nutrition Humaine d'Auvergne (CRNH), Unité d'Exploration Nutritionnelle, Laboratoire de Nutrition humaine


title: Active Detection and Management of the Extension of Atherothrombosis in High Risk Coronary Patients In Comparison With Standard of Care for Coronary Atherosclerosis: The AMERICA Study

acronym: AMERICA

summary: Coronary artery disease is the first cause of death related to atherothrombosis.

ReferenceCitation: Collet JP, Cayla G, Ennezat PV, Leclercq F, Cuisset T, Elhadad S, Henry P, Belle L, Cohen A, Silvain J, Barthelemy O, Beygui F, Diallo A, Vicaut E, Montalescot G; AMERICA Investigators. Systematic detection of polyvascular disease combined with aggressive secondary prevention in patients presenting with severe coronary artery disease: The randomized AMERICA Study. Int J Cardiol. 2018 Mar 1;254:36-42. doi: 10.1016/j.ijcard.2017.11.081. Epub 2018 Jan 28.

family: Collet

full_name: Jean-Philippe Collet

given: Jean-Philippe

family: Cayla

full_name: Guillaume Cayla

given: Guillaume

family: Ennezat

full_name: Pierre-Vladimir Ennezat

given: Pierre-Vladimir

family: Leclercq

full_name: Florence Leclercq

given: Florence

family: Cuisset

full_name: Thomas Cuisset

given: Thomas

family: Elhadad

full_name: Simon Elhadad

given: Simon

family: Henry

full_name: Patrick Henry

given: Patrick

family: Belle

full_name: Loic Belle

given: Loic

family: Cohen

full_name: Ariel Cohen

given: Ariel

family: Silvain

full_name: Johanne Silvain

given: Johanne

family: Barthelemy

full_name: Olivier Barthelemy

given: Olivier

family: Beygui

full_name: Farzin Beygui

given: Farzin

family: Diallo

full_name: Abdourahmane Diallo

given: Abdourahmane

family: Vicaut

full_name: Eric Vicaut

given: Eric

family: Montalescot

full_name: Gilles Montalescot

given: Gilles

journal_name: International Journal of Cardiology


title: Efficacy Study of Diacerein in the Symptomatic Treatment of Knee Osteoarthritis

summary: Pain is the main symptom of osteoarthritis that motivates medical visits. Diacerhein has already demonstrated its efficacy in knee and/or hip osteoarthritis. This study aims at confirming the efficacy of diacerhein in symptomatic knee osteoarthritis using known and validated criteria and according to the recommendations and guidelines for this kind of study.

lead_sponsor: Laboratoires NEGMA


title: Study of Evaluation of the Profile of Efficiency / Tolerance of 2 Doses of Intravenous Droperidol in the Prevention of the Postoperative Nausea and Vomits Related to the Surgery of the Thyroid

acronym: DIPAVO

summary: In this prospective, randomised, placebo-controlled study, the researchers determined whether 0.625 mg or 2.5 mg of IV droperidol given 30 min before emergence from general anaesthesia reduces the incidence of immediate and delayed post operative nausea and vomiting (PONV) in thyroid surgical female population. Two hundred and forty six female patients receiving general anaesthesia for thyroid surgery received either droperidol 0.625 mg or droperidol 2.5 mg or placebo before emergence.

ReferenceCitation: Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. Review.

ReferenceCitation: Williams OA, Clarke FL, Harris RW, Smith P, Peacock JE. Addition of droperidol to patient-controlled analgesia: effect on nausea and vomiting. Anaesthesia. 1993 Oct;48(10):881-4.

ReferenceCitation: Gan TJ, Meyer T, Apfel CC, Chung F, Davis PJ, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramèr MR, Watcha M; Department of Anesthesiology, Duke University Medical Center. Consensus guidelines for managing postoperative nausea and vomiting. Anesth Analg. 2003 Jul;97(1):62-71, table of contents. Review.

ReferenceCitation: Wang JJ, Ho ST, Lee SC, Liu YC, Liu YH, Liao YC. The prophylactic effect of dexamethasone on postoperative nausea and vomiting in women undergoing thyroidectomy: a comparison of droperidol with saline. Anesth Analg. 1999 Jul;89(1):200-3.

ReferenceCitation: Henzi I, Sonderegger J, Tramèr MR. Efficacy, dose-response, and adverse effects of droperidol for prevention of postoperative nausea and vomiting. Can J Anaesth. 2000 Jun;47(6):537-51. Review.

location_facility: Département d'Anesthésie-Réanimation II ; Groupe Hospitalier Sud, CHU de Bordeaux


title: Pathophysiological Study of Allergic Contact Dermatitis to Para-Phenylenediamine (PPD). Analysis of Cellular and Molecular Targets in Skin Inflammation

summary:
The current knowledge of the pathophysiology of allergic contact dermatitis is based on the murine model. In this model, CD8+ T cells are effector cells, and CD4+ T cells regulate the response by limiting the expansion of CD8+ T cells. The goal of this study is to characterize the pathophysiology of contact dermatitis, with patients allergic to para-phenylenediamine (PPD).

We suppose that the CD8+ T cells are the effectors of the allergic contact dermatitis, although the regulator cells belong to the LT CD4+ population. We will test our hypothesis on blood samples, and cutaneous biopsies of patients allergic to PPD.

lead_sponsor: Hospices Civils de Lyon


title: Angioplasty to Blunt the Rise of Troponin in Acute Coronary Syndromes Randomized for an Immediate or Delayed Intervention (The ABOARD Study)

acronym: ABOARD

summary: Release of troponin evaluated by the peak of troponin during the hospital phase.Because of its sensitivity and specificity as well as its widespread use in routine practice, rise in troponin levels is the main assessment criteria of this study. We plan to demonstrate a significantly altered distribution of the troponin release as evaluated by the peak of troponin for each patient during the hospitalization period (from randomization to cardiologic unit discharge), in the two arms of the trial.

ReferenceCitation: Barthélémy O, Cayla G, Silvain J, O'Connor SA, Bellemain-Appaix A, Beygui F, Sideris G, Varenne O, Collet JP, Vicaut E, Montalescot G; ABOARD Investigators. Optimal time for catheterization in NSTE-ACS patients with impaired renal function: insights from the ABOARD Study. Int J Cardiol. 2013 Sep 10;167(6):2646-52. doi: 10.1016/j.ijcard.2012.06.126. Epub 2012 Jul 12.

family: Barthélémy

full_name: O. Barthélémy

given: O.

full_name: G. Cayla

given: G.

full_name: J. Silvain

given: J.

family: O'Connor

full_name: S.A. O'Connor

family: Bellemain-Appaix

full_name: A. Bellemain-Appaix

given: A.

full_name: F. Beygui

given: F.

family: Sideris

full_name: G. Sideris

family: Varenne

full_name: O. Varenne

full_name: J.P. Collet

full_name: E. Vicaut

given: E.

full_name: G. Montalescot

ReferenceCitation: Montalescot G, Cayla G, Collet JP, Elhadad S, Beygui F, Le Breton H, Choussat R, Leclercq F, Silvain J, Duclos F, Aout M, Dubois-Randé JL, Barthélémy O, Ducrocq G, Bellemain-Appaix A, Payot L, Steg PG, Henry P, Spaulding C, Vicaut E; ABOARD Investigators. Immediate vs delayed intervention for acute coronary syndromes: a randomized clinical trial. JAMA. 2009 Sep 2;302(9):947-54. doi: 10.1001/jama.2009.1267.

family: Le Breton

full_name: Hervé Le Breton

given: Hervé

family: Choussat

full_name: Rémi Choussat

given: Rémi

family: Duclos

full_name: François Duclos

given: François

title: Immediate vs Delayed Intervention for Acute Coronary Syndromes

location_facility: Institut de Cardiologie - Hôpital Pitié-Salpétrière


title: A Randomized, Double-Blind, Vehicle-Controlled, Single Center, Intra-Individual Comparative Study of the Efficacy and Safety of Diclofenac Sodium 1 mg/g (0.1%) Gel in Subjects With Painful UV-Induced Erythema

summary: Diclofenac sodium 0.1% will be applied to sunburned skin when the intensity of pain reaches a certain level in order to evaluate the efficacy and safety of the treatment on this induced pain.

lead_sponsor: Novartis


title: Changes of Transforming Growth Factor b1 and Procollagen III in Patients With Acute Respiratory Distress Syndrome

summary:
Transforming Growth Factor-b1 (TGF-b1) is involved in the development of acute lung injury and in the fibroproliferation during acute respiratory distress syndrome (ARDS). Procollagen III Peptide (PIIINP) is a validated marker of fibroproliferation. PIIINP is associated with death in ARDS patients. The simultaneous changes of TGF-b1 and PIIINP were never studied in patients with ARDS. The relationships between TGF-b1 and the outcome of ARDS are unknown.

The aim of the study is to analyse the changes of TGF-b1 and PIIINP during ARDS and to show the relationships between TGF-b1 - PIIINP and the outcomes of ARDS.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Interventional, Open-label Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care

summary: To determine the reduction in alcohol consumption in patients with alcohol dependence treated with 18 mg Selincro® as-needed use, in conjunction with continuous psychosocial support in primary care

lead_sponsor: H. Lundbeck A/S

location_country:
Germany
United Kingdom
France
Spain