title: Complications of Jugular and Femoral Venous Catheterization in Critically Ill Patients Requiring Hemodialysis: A Randomized Controlled Trial

acronym: CATHEDIA

summary: The purpose of this study is to determine whether a jugular route leads to a lower rate of complications as compared with a femoral route for catheterization in patients admitted in several intensive care units in France who develop acute renal failure requiring hemodiafiltration or hemodialysis.

ReferenceCitation: Parienti JJ, Thirion M, Mégarbane B, Souweine B, Ouchikhe A, Polito A, Forel JM, Marqué S, Misset B, Airapetian N, Daurel C, Mira JP, Ramakers M, du Cheyron D, Le Coutour X, Daubin C, Charbonneau P; Members of the Cathedia Study Group. Femoral vs jugular venous catheterization and risk of nosocomial events in adults requiring acute renal replacement therapy: a randomized controlled trial. JAMA. 2008 May 28;299(20):2413-22. doi: 10.1001/jama.299.20.2413.

family: Parienti

full_name: Jean-Jacques Parienti

given: Jean-Jacques

family: Thirion

full_name: Marina Thirion

given: Marina

family: Mégarbane

full_name: Bruno Mégarbane

given: Bruno

family: Souweine

full_name: Bertrand Souweine

given: Bertrand

family: Ouchikhe

full_name: Abdelali Ouchikhe

given: Abdelali

family: Polito

full_name: Andrea Polito

given: Andrea

family: Forel

full_name: Jean-Marie Forel

given: Jean-Marie

family: Marqué

full_name: Sophie Marqué

given: Sophie

family: Misset

full_name: Benoît Misset

given: Benoît

family: Airapetian

full_name: Norair Airapetian

given: Norair

family: Daurel

full_name: Claire Daurel

given: Claire

family: Mira

full_name: Jean-Paul Mira

given: Jean-Paul

family: Ramakers

full_name: Michel Ramakers

given: Michel

family: du Cheyron

full_name: Damien du Cheyron

given: Damien

family: Le Coutour

full_name: Xavier Le Coutour

given: Xavier

family: Daubin

full_name: Cédric Daubin

given: Cédric

family: Charbonneau

full_name: Pierre Charbonneau

family: for Members of the Cathedia Study Group

full_name: for Members of the Cathedia Study Group

journal_name: JAMA

oa_host_type: publisher

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Femoral vs Jugular Venous Catheterization and Risk of Nosocomial Events in Adults Requiring Acute Renal Replacement Therapy

ReferenceCitation: Parienti JJ, Mégarbane B, Fischer MO, Lautrette A, Gazui N, Marin N, Hanouz JL, Ramakers M, Daubin C, Mira JP, Charbonneau P, du Cheyron D; Cathedia Study Group. Catheter dysfunction and dialysis performance according to vascular access among 736 critically ill adults requiring renal replacement therapy: a randomized controlled study. Crit Care Med. 2010 Apr;38(4):1118-25. doi: 10.1097/CCM.0b013e3181d454b3.

title: Catheter dysfunction and dialysis performance according to vascular access among 736 critically ill adults requiring renal replacement therapy: A randomized controlled study

ReferenceCitation: Parienti JJ, Dugué AE, Daurel C, Mira JP, Mégarbane B, Mermel LA, Daubin C, du Cheyron D; Members of the Cathedia Study Group. Continuous renal replacement therapy may increase the risk of catheter infection. Clin J Am Soc Nephrol. 2010 Aug;5(8):1489-96. doi: 10.2215/CJN.02130310. Epub 2010 Jun 17.

journal_name: Clinical Journal of the American Society of Nephrology

title: Continuous Renal Replacement Therapy May Increase the Risk of Catheter Infection

ReferenceCitation: Dugué AE, Levesque SP, Fischer MO, Souweine B, Mira JP, Megarbane B, Daubin C, du Cheyron D, Parienti JJ; Cathedia Study Group. Vascular access sites for acute renal replacement in intensive care units. Clin J Am Soc Nephrol. 2012 Jan;7(1):70-7. doi: 10.2215/CJN.06570711. Epub 2011 Nov 10.

title: Vascular Access Sites for Acute Renal Replacement in Intensive Care Units

ReferenceCitation: Parienti JJ, Deryckère S, Mégarbane B, Valette X, Seguin A, Sauneuf B, Mira JP, Souweine B, Cattoir V, Daubin C, du Cheyron D; Cathedia Study Group. Quasi-experimental study of sodium citrate locks and the risk of acute hemodialysis catheter infection among critically ill patients. Antimicrob Agents Chemother. 2014 Oct;58(10):5666-72. doi: 10.1128/AAC.03079-14. Epub 2014 Jun 30.

title: Quasi-Experimental Study of Sodium Citrate Locks and the Risk of Acute Hemodialysis Catheter Infection among Critically Ill Patients

ReferenceCitation: Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9:CD013330. doi: 10.1002/14651858.CD013330.pub2. Review.

name: Department of Health Promotion and Human Behavior; Kyoto University Graduate School of Medicine / School of Public Health; Kyoto Japan

name: Department of Nephrology and Dialysis; Kyoritsu Hospital; Kawanishi Japan

name: Systematic Review Workshop Peer Support Group (SRWS-PSG); Osaka Japan

name: Department of Nephrology; Sumitomo Hospital; Osaka Japan

name: Department of Nephrology; Hyogo Prefectural Amagasaki General Medical Center; Amagasaki Japan

name: Hospital Care Research Unit; Hyogo Prefectural Amagasaki General Medical Center; Hyogo Japan

name: Department of Emergency and Critical Care Medicine; Jichi Medical University Saitama Medical Center; Saitama-shi Japan

name: Department of Internal Medicine; Kyoto Min-Iren Asukai Hospital; Kyoto Japan

name: Department of Healthcare Epidemiology; Kyoto University Graduate School of Medicine / School of Public Health; Kyoto Japan

name: Section of Clinical Epidemiology, Department of Community Medicine; Kyoto University Graduate School of Medicine; Kyoto Japan

name: Intensive Care Unit; Jikei University Hospital; Tokyo Japan

name: ANZIC-RC; Monash University School of Public Health and Preventive Medicine; Melbourne Australia

location_facility: Medical and nephrologic Intensive Care Unit, CHU Amien Sud

location_facility: Medical Intensive Care Unit, CHU de Caen


title: Prospective Study : Podocyturia as Predictive Factor for Pre-eclampsia

summary: Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious maternal, fetal and neonatal mortality and morbidity. Podocyn could be identified in the urine, before proteinuria, a key element in the diagnostic of pre-eclampsia. Preventive treatment using aspirin could be administrated in early pregnancy. We hypothesized that podocyturia could be an early indicator of preeclampsia. This is a prospective, non-interventional, monocentric study.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Prospective Study : Association Between Pococyturia and Pre-eclampsia Severity

summary: Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious maternal, fetal and neonatal mortality and morbidity. Twenty four hours proteinuria is a key element to define pre-eclampsia severity but is delaying the result by 24 hours and constraining for the patient. A simple and rapid indicator for severe preeclampsia would help clinicians to make appropriate decision in patient management. We hypothesized that urinary podocyturia is correlated to preeclampsia severity. This is a prospective, non-interventional, monocentric study.


title: Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice

summary: This is an observational, multicenter study in patients treated with nivolumab for the approved indications of melanoma and lung cancer in Australia, the EU, Switzerland, and the United States (US). Targeted countries in the EU for study participation include Austria, Belgium, France, Germany, Italy, Spain, Czech Republic, Hungary, Poland and the United Kingdom (UK). Study objectives are to assess the safety experience, survival, adverse event management, and outcomes of adverse events associated with nivolumab in routine oncology care facilities.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
Switzerland
Germany
France
Czechia
Poland
Hungary
Australia
Belgium
Puerto Rico
Spain
United States
United Kingdom

location_facility: St. Joseph's/Candler SC Cancer Specialist

location_facility: Atlantic Health System/Overlook Medical Center

location_facility: Semmelweis Hospital and University Teaching Hospital Miskolc, Department of Pulmonology

location_facility: OKPI Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: Samodzielny Publiczny Zespół Gruźlicy i Chorób Płuc, Oddzial Onkologii z Pododzialem Chemioterapii

location_facility: Veszprem Megyei Tudogyogyintezet Farkasgyepu

location_facility: Csongrad Megyei Mellkasi Betegsegek Szakkorhaza

location_facility: CHRISTUS Health St Frances Cabrini Hospital Cancer Center

location_facility: Klinika plicnich nemoci Fakultni nemocnice Olomouc

location_facility: Opolskie Centrum Onkologii im. Prof. T. Koszarowskiego w Opolu, Oddział Onkologii Klinicznej z Odcinkiem Dziennym

location_facility: University of Debrecen, Clinical Centre Departure of Pulmonology- Debreceni Egyetem Klinikai Központ Tüdőgyógyászati Klinika

lead_sponsor_type: industriel


title: International Validation of a Sexual Quality of Life Questionnaire Specific to HIV and Hepatitis C Infections (PROQOL-SexLife)

acronym: SexLife

summary: To develop and validate a specific questionnaire of sexual quality of life in several languages and cultures (France, Brazil, Australia) allowing a meaningful and comprehensive assessment of the sexuality of patients infected with HIV and HCV; Propose reference scoring for sub-populations.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: WHO | Sexual health [Internet]. WHO. Available from: http://www.who.int/topics/sexual_health/en/

ReferenceCitation: Koole O, Noestlinger C, Colebunders R. Quality of life in HIV clinical trials: why sexual health must not be ignored. PLoS Clin Trials. 2007 Mar 2;2(3):e8.

ReferenceCitation: Marcellin F, Préau M, Ravaux I, Dellamonica P, Spire B, Carrieri MP. Self-reported fatigue and depressive symptoms as main indicators of the quality of life (QOL) of patients living with HIV and Hepatitis C: implications for clinical management and future research. HIV Clin Trials. 2007 Sep-Oct;8(5):320-7.

ReferenceCitation: Sandfort TG, Collier KL, Grossberg R. Addressing sexual problems in HIV primary care: experiences from patients. Arch Sex Behav. 2013 Oct;42(7):1357-68. doi: 10.1007/s10508-012-0009-5. Epub 2012 Sep 11.

ReferenceCitation: Meystre-Agustoni G, Jeannin A, de Heller K, Pécoud A, Bodenmann P, Dubois-Arber F. Talking about sexuality with the physician: are patients receiving what they wish? Swiss Med Wkly. 2011 Mar 8;141:w13178. doi: 10.4414/smw.2011.13178. eCollection 2011.

ReferenceCitation: Dyer K, das Nair R. Why don't healthcare professionals talk about sex? A systematic review of recent qualitative studies conducted in the United kingdom. J Sex Med. 2013 Nov;10(11):2658-70. doi: 10.1111/j.1743-6109.2012.02856.x. Epub 2012 Jul 30. Review.

ReferenceCitation: Soykan A, Boztaş H, Idilman R, Ozel ET, Tüzün AE, Ozden A, Ozden A, Kumbasar H. Sexual dysfunctions in HCV patients and its correlations with psychological and biological variables. Int J Impot Res. 2005 Mar-Apr;17(2):175-9.

ipd_sharing: Undecided

lead_sponsor: University Paris 7 - Denis Diderot

location_country: Brazil Canada Australia France

location_facility: Centre Hépato -Biliaire de l'Hôpital Paul Brousse

status_simplified: Completed


title: Analysis of Viral Infections' Exposition Preceding the Type 1 Diabetes (T1D) Diagnostic in Children of the Isis-Diab Cohort. Search for Explanations of of the Disease's Early Onset

acronym: ISIS-VIRUS

summary: The purpose of this study is to investigate viral factors determining the early onset of T1D. Thanks to the quantification of viral exposures of T1D patients before the disease onset with questionnaires and environmental databases analyses, and through whole genome association studies of these patients, investigators could attempt to identify gene-virus interactions determining the age of T1D onset.

status: Unknown status

time_perspective: Retrospective

lead_sponsor: Assistance Publique - Hôpitaux de Paris

status_simplified: Unknown


title: Antioxidants Supplementation Associated With Pulmonary Rehabilitation is it Effective on Muscle Dysfunction and Signaling Pathways Involved in the Myopathy of COPD?

summary: On the basis of published data and investigators results indicating that systemic redox in balance may contribute to the peripheral muscle dysfunction in COPD patients, the investigators propose a study testing the effects of antioxidants and exercise training in COPD patients. The results may have major implication in the improvement of pulmonary rehabilitation benefits

study_type: Interventional

design_allocation: Randomized

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Gouzi F, Maury J, Héraud N, Molinari N, Bertet H, Ayoub B, Blaquière M, Bughin F, De Rigal P, Poulain M, Pincemail J, Cristol JP, Laoudj-Chenivesse D, Mercier J, Préfaut C, Pomiès P, Hayot M. Additional Effects of Nutritional Antioxidant Supplementation on Peripheral Muscle during Pulmonary Rehabilitation in COPD Patients: A Randomized Controlled Trial. Oxid Med Cell Longev. 2019 Apr 17;2019:5496346. doi: 10.1155/2019/5496346. eCollection 2019.

name: PhyMedExp, Montpellier University, INSERM U1046, CNRS UMR 9214, Montpellier University Hospital, France

family: Gouzi

full_name: Fares Gouzi

given: Fares

sequence: first

name: PhyMedExp, Montpellier University, INSERM U1046, CNRS UMR 9214, France

name: Pulmonary Rehabilitation Centers Les Cliniques du Souffle®, 5 Santé/Fontalvie Corporation, 66350 Toulouges, France

family: Maury

full_name: Jonathan Maury

given: Jonathan

sequence: additional

family: Héraud

full_name: Nelly Héraud

given: Nelly

name: IMAG, CNRS, Montpellier University, Montpellier University Hospital, Montpellier, France

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

family: Bertet

full_name: Héléna Bertet

given: Héléna

family: Ayoub

full_name: Bronia Ayoub

given: Bronia

family: Blaquière

full_name: Marine Blaquière

given: Marine

family: Bughin

full_name: François Bughin

given: François

family: De Rigal

full_name: Philippe De Rigal

given: Philippe

family: Poulain

full_name: Magali Poulain

given: Magali

name: Department of Cardiovascular Surgery and CREDEC, University of Liège, Sart Tilman University Hospital, 4000 Liège, Belgium

family: Pincemail

full_name: Joël Pincemail

given: Joël

family: Cristol

full_name: Jean-Paul Cristol

family: Laoudj-Chenivesse

full_name: Dalila Laoudj-Chenivesse

given: Dalila

family: Mercier

full_name: Jacques Mercier

given: Jacques

family: Préfaut

full_name: Christian Préfaut

given: Christian

family: Pomiès

full_name: Pascal Pomiès

given: Pascal

family: Hayot

full_name: Maurice Hayot

given: Maurice

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Oxidative Medicine and Cellular Longevity

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: Hindawi - Hindawi

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

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

location_facility:
Clinique du souffle la vallonie
University Hospital of Montpellier


title: Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus (Relais Oral Dans le Traitement Des Endocardites à Streptocoques Multi-sensibles)

summary:
Infective endocarditis (IE) is a serious infection with a significant burden for patients and hospitals (in France, median length of hospital stay = 43 days), partly due to the long duration of intravenous (IV) antibacterial treatment recommended by international guidelines, between 4 and 6 weeks in most situations.

A recent survey of practices regarding the management of IE in France showed that a switch from IV to oral antibiotics is feasible, when patients with left-sided Streptococcus-Enterococcus IE are stable after an initial course of IV antibiotic treatment, with or without valvular surgery.

These practices have not been associated with unfavourable outcome, while significantly reducing the duration and cost of hospitalization, the risk of nosocomial infection, and patients' discomfort.

There has been no randomized controlled trial (RCT) in the field of IE over the last 20 years; current guidelines are mostly based on expert advice, in vitro studies, animal experiments, or clinical studies performed before the 90's.

The RODEO 2 project is an unprecedented opportunity to bring back evidence-based medicine in the field of IE.

Most experts acknowledge that the pharmacological PK/PD characteristics of antibiotics such as amoxicillin allow a high level of efficacy in the treatment of IE when orally administrated after an IV period of induction.

It's needed to conduct RCTs that clearly demonstrate the clinical non-inferiority of this strategy for streptococci, and enterococci IE with a benefit regarding costs.

The RODEO 2 project corresponds to one pragmatic trial assessing the impact of a switch strategy, making it a comparative effectiveness trial that should be able to feed the next revision of IE international guidelines and to change practices in IE management.

primary_purpose: Treatment

ReferenceCitation: Lemaignen A, Bernard L, Tattevin P, Bru JP, Duval X, Hoen B, Brunet-Houdard S, Mainardi JL, Caille A; RODEO (Relais Oral Dans le traitement des Endocardites à staphylocoques ou streptOcoques) and AEPEI (Association pour l'Etude et la Prévention de l'Endocardite Infectieuse) study groups. Oral switch versus standard intravenous antibiotic therapy in left-sided endocarditis due to susceptible staphylococci, streptococci or enterococci (RODEO): a protocol for two open-label randomised controlled trials. BMJ Open. 2020 Jul 14;10(7):e033540. doi: 10.1136/bmjopen-2019-033540.

ipd_sharing: Yes

ipd_sharing_description:
There are no plans to grant public access to the full protocol, participant-level data or statistical code. Data from the RODEO trials is stored by the promotor of the trial. Data and the personal identifiers are stored separately and a special permit is required for access to the data. Data can be available on request for academic researchers when it have been analysed and published. Qualified researchers can ask for data sharing by the first author LB after the study finalization.

Open Access This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work noncommercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http:// creativecommons.org/licenses/by-nc/4.0/

lead_sponsor: University Hospital, Tours

location_facility: Service des Maladies infectieuses et tropicales, CH Le Mans

location_facility: Service de Microbiologie, Hôpital Européen Georges Pompidou, APHP

location_facility: Service des Maladie infectieuses et tropicales, Hôpital d'instruction des armées Bégin

location_facility: Service de maladies infectieuses et tropicales, Hôpital Avicenne, APHP

location_facility: Service de médecine interne, Hôpital Ambroise Paré, APHP

location_facility: CHU St Etienne - Service des maladies infectieuses et tropicales

location_facility: Service des maladies infectieuses, Centre Hospitalier du Pays d'Aix

location_facility: Institut Mutualiste Montsouris - Service de médecine interne

location_facility: Service de Maladies infectieuses, Hôpital de la Cavale Blanche, CHU Brest

location_facility: CH PAU - Service de Médecine interne et Maladies infectieuses

location_facility: Consultation de Médecine Interne, maladies infectieuses et tropicales, CH intercommunal de Villeneuve St Georges

location_facility: Infectiologie, médecine interne et médecine des voyages, CH d'Annecy

location_facility: Service de Maladies infectieuses et tropicales médecine interne, CH Métropole Savoie

location_facility: Service d'Infectiologie, Hôpital de l'Archet, CHU de Nice

location_facility: Service de Cardiologie, Hôpitall Louis Pradel, Hôpitaux Est, Hospices Civils de Lyon

location_facility: Service de court séjour gériatrique - EMG, Centre hospitalier d'Alès

location_facility: CHU ANGERS - Service des maladies infectieuses et tropicales

location_facility: Service de Maladies infectieuses et tropicales, Hôpital de la Source, CHR Orléans

location_facility: Service des Maladies infectieuses et tropicales, Hôpital de Purpan, CHU de Toulouse

location_facility: Service des maladies infectieuses et tropicales, Hôpital G. Montpied, CHU de Clermont-Ferrand

location_facility: Service de Médecine interne polyvalente et neurologique CH de Douai

location_facility: CHU Toulouse (Rangueil) Service de Cardiologie

location_facility: Service de Réanimation médicale, Hôpital St André, CHU de Bordeaux

location_facility: Service de Médecine interne et maladies infectieuses, Hôpital Bretonneau, CHU de Tours

location_facility: Unité médicale d'infectiologie, Hôpital Huriez, CHU de Lille

location_facility: Service de Maladies infectieuses et tropicales, Hôpital Hôtel Dieu, CHU Nantes

location_facility: APHP Henri-Mondor - Service des maladies infectieuses et tropicales

location_facility: Service de Maladies infectieuses et tropicales, Hôpitaux de Brabois, CHU de Nancy

location_facility: Service Universitaire des Maladies Infectieuses et du voyageur, CH de Tourcoing

location_facility: Service des Maladies infectieuses, CH de Niort

location_facility: Service des maladies infectieuses et réanimation médicale, Hôpital Pontchaillou, CHU de Rennes

location_facility: Service Maladies Infectieuses et tropicales, Hôpital Côte de Nacre, CHU de Caen

location_facility: Service des maladies respiratoires et infectieuses, CH de St Malo

location_facility: Service de maladies infectieuses et tropicales, Hôpital Necker, APHP

location_facility: Service des Maladies infectieuses et tropicales, CH de Perpignan

location_facility: Service de Médecine infectieuse, Hôpital Nord Michallon, CHU de Grenoble

location_facility: Département d'infectiologie, Complexe Bocage, Hôpital d'enfants, CHU de Dijon

location_facility: Service de Maladies Infectieuses et tropicales, Hôpital Dupuytren, CHU de Limoges

location_facility: Service de maladies infectieuses, parasitaires et tropicales, Hôpital Bichat, APHP

location_facility: Service de Maladies infectieuses, Hôpital Gui de CHauliac, CHU de Montpellier

location_facility: Service des Maladies infectieuses et Tropicales, Hôpital Jean Minjoz, CHU de Besançon

location_facility: Service de médecine post-urgence, infectiologie, Site de la Roche sur Yon, CHD Vendée

location_facility: Service de Maladies infectieuses et tropicales, et pathologie VIH, Hôpital A Mignot, CH de Versailles

location_facility: Service de médecine aigue spécifique, Hôpital Raymond Poincaré, APHP

location_facility: Service de Pathologies infectieuses et tropicales, Hôpital Nord, CHU d'Amiens

location_facility: APHP BICETRE - Service des maladies infectieuses et tropicales

location_facility: Service des Maladies Infectieuses et Tropicales, Hôpital Carémeau, CHU de Nîmes

location_facility: Service de Médecine interne, maladies infectieuses, immunologie clinique, Hôpital R. Debré, CHU de Reims

location_facility: Service de Médecine interne, maladies infectieuses et tropicales, CHU de Poitiers

location_facility: Service des Maladies infectieuses et tropicales, Hôpital Charles Nicolle, CHU de Rouen

intervention_type: Procedure


title: Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Staphylococcus (Relais Oral Dans le Traitement Des Endocardites à Staphylocoques Multi-sensibles)

summary:
Infective endocarditis (IE) is a serious infection with a significant burden for patients and hospitals (in France, median length of hospital stay = 43 days), partly due to the long duration of intravenous (IV) antibacterial treatment recommended by international guidelines, between 4 and 6 weeks in most situations.

A recent survey of practices regarding the management of IE in France showed that a switch from IV to oral antibiotics is feasible, when patients with left-sided Staphylococcus IE are stable after an initial course of IV antibiotic treatment, with or without valvular surgery.

These practices have not been associated with unfavourable outcome, while significantly reducing the duration and cost of hospitalization, the risk of nosocomial infection, and patients' discomfort.

There has been no randomized controlled trial (RCT) in the field of IE over the last 20 years; current guidelines are mostly based on expert advice, in vitro studies, animal experiments, or clinical studies performed before the 90's.

The RODEO 1 project is an unprecedented opportunity to bring back evidence-based medicine in the field of IE.

Most experts acknowledge that the pharmacological PK/PD characteristics of antibiotics such as fluoroquinolones and rifampicin allow a high level of efficacy in the treatment of IE when orally administrated after an IV period of induction.

It's needed to conduct RCTs that clearly demonstrate the clinical non-inferiority of this strategy for multisusceptible staphylococci with a benefit regarding costs.

The RODEO 1 project corresponds to one pragmatic trial assessing the impact of a switch strategy, making it a comparative effectiveness trial that should be able to feed the next revision of IE international guidelines and to change practices in IE management.

location_facility: Service de Médecine aigue spécifique, Hôpital Raymond Poincaré, APHP

location_facility: Service des Maladies infectieuses et tropicales, CH Le Mans

location_facility: Service de Microbiologie, Hôpital Européen Georges Pompidou, APHP

location_facility: Service des Maladie infectieuses et tropicales, Hôpital d'instruction des armées Bégin

location_facility: Service de Médecine post-urgence, infectiologie, Site de la Roche sur Yon, CHD Vendée

location_facility: CHU St Etienne - Service des maladies infectieuses et tropicales

location_facility: Institut Mutualiste Montsouris - Service de médecine interne

location_facility: Service de Médecine interne, Hôpital Ambroise Paré, APHP

location_facility: Service des Maladies infectieuses, Centre Hospitalier du Pays d'Aix

location_facility: CH PAU - Service de Médecine interne et Maladies infectieuses

location_facility: Consultation de Médecine Interne, maladies infectieuses et tropicales, CH intercommunal de Villeneuve St Georges

location_facility: Infectiologie, médecine interne et médecine des voyages, CH d'Annecy

location_facility: Service d'Infectiologie, Hôpital de l'Archet, CHU de Nice

location_facility: Service de Cardiologie, Hôpitall Louis Pradel, Hôpitaux Est, Hospices Civils de Lyon

location_facility: Service de court séjour gériatrique - EMG, Centre hospitalier d'Alès

location_facility: CHU ANGERS - Service des maladies infectieuses et tropicales

location_facility: Service de Maladies infectieuses et tropicales, Hôpital de la Source, CHR Orléans

location_facility: Service des Maladies infectieuses et tropicales, Hôpital de Purpan, CHU de Toulouse

location_facility: Service des maladies infectieuses et tropicales, Hôpital G. Montpied, CHU de Clermont-Ferrand

location_facility: Service de Médecine interne polyvalente et neurologique CH de Douai

location_facility: Service de Maladies infectieuses et tropicales, médecine interne, CH de Chambéry

location_facility: Service de Réanimation médicale, Hôpital St André, CHU de Bordeaux

location_facility: CHU Toulouse (Rangueil) Service de Cardiologie

location_facility: Service de Médecine interne et maladies infectieuses, Hôpital Bretonneau, CHU de Tours

location_facility: Unité médicale d'infectiologie, Hôpital Huriez, CHU de Lille

location_facility: Service de Maladies infectieuses et tropicales, Hôpital Hôtel Dieu, CHU Nantes

location_facility: Service de Maladies infectieuses et tropicales, et pathologie VIH

location_facility: APHP Henri-Mondor - Service des maladies infectieuses et tropicales

location_facility: Service de Maladies infectieuses et tropicales, Hôpitaux de Brabois, CHU de Nancy

location_facility: Service Universitaire des Maladies Infectieuses et du voyageur, CH de Tourcoing

location_facility: Service des Maladies infectieuses, CH de Niort

location_facility: Service des maladies infectieuses et réanimation médicale, Hôpital Pontchaillou, CHU de Rennes

location_facility: Service Maladies Infectieuses et tropicales, Hôpital Côte de Nacre, CHU de Caen

location_facility: Service des maladies respiratoires et infectieuses, CH de St Malo

location_facility: Service de Maladies infectieuses, Hôpital de la Cavale Blanche

location_facility: Service de Maladies infectieuses et tropicales, Hôpital Necker, APHP

location_facility: Service de Maladies infectieuses, parasitaires et tropicales, Hôpital Bichat, APHP

location_facility: Service de Maladies infectieuses et tropicales, Hôpital Avicenne, APHP


title: Zephyr Etude Post-Inscription (French Registry)

summary: The objective of this Registry is to provide ongoing safety and effectiveness assessment of the Zephyr Valve treatment of adult patients with Chronic Obstructive Pulmonary Disease (COPD) Grade III and Grade IV in order to support the renewal of the inscription of the Zephyr Valve on the list LPPR (Art 165-1) in France.

ReferenceCitation: Criner GJ, Sue R, Wright S, Dransfield M, Rivas-Perez H, Wiese T, Sciurba FC, Shah PL, Wahidi MM, de Oliveira HG, Morrissey B, Cardoso PFG, Hays S, Majid A, Pastis N Jr, Kopas L, Vollenweider M, McFadden PM, Machuzak M, Hsia DW, Sung A, Jarad N, Kornaszewska M, Hazelrigg S, Krishna G, Armstrong B, Shargill NS, Slebos DJ; LIBERATE Study Group. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE). Am J Respir Crit Care Med. 2018 Nov 1;198(9):1151-1164. doi: 10.1164/rccm.201803-0590OC.

ReferenceCitation: Kemp SV, Slebos DJ, Kirk A, Kornaszewska M, Carron K, Ek L, Broman G, Hillerdal G, Mal H, Pison C, Briault A, Downer N, Darwiche K, Rao J, Hübner RH, Ruwwe-Glosenkamp C, Trosini-Desert V, Eberhardt R, Herth FJ, Derom E, Malfait T, Shah PL, Garner JL, Ten Hacken NH, Fallouh H, Leroy S, Marquette CH; TRANSFORM Study Team *. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM). Am J Respir Crit Care Med. 2017 Dec 15;196(12):1535-1543. doi: 10.1164/rccm.201707-1327OC.

name: Royal Brompton Hospital and Imperial College London, London, United Kingdom

name: Sherwood Forest Hospitals, NHS Foundation Trust, Nottinghamshire, United Kingdom

family: Kemp

full_name: Samuel V. Kemp

given: Samuel V.

name: Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands

family: Slebos

full_name: Dirk-Jan Slebos

given: Dirk-Jan

name: Department of Thoracic Surgery, West of Scotland Regional Heart & Lung Centre, Golden Jubilee National Hospital, West Dunbartonshire, Scotland, United Kingdom

family: Kirk

full_name: Alan Kirk

given: Alan

name: Department of Cardiothoracic Surgery, University Hospital of Wales, Cardiff, United Kingdom

family: Kornaszewska

full_name: Malgorzata Kornaszewska

given: Malgorzata

name: Department of Pulmonology, AZ Delta, Menen, Belgium

family: Carron

full_name: Kris Carron

given: Kris

name: Department of Pulmonary Diseases, Skane University Hospital, Lund, Sweden

family: Ek

full_name: Lars Ek

given: Lars

name: Department of Pulmonary Diseases, Uppsala University Hospital, Uppsala, Sweden

family: Broman

full_name: Gustav Broman

given: Gustav

family: Hillerdal

full_name: Gunnar Hillerdal

given: Gunnar

name: Service de Pneumologie A, Hôpital Bichat, Paris, France

family: Mal

full_name: Herve Mal

given: Herve

name: Clinique Universitaire de Pneumologie, Pôle Thorax et Vaisseaux, CHU Grenoble Alpes, Grenoble, France

family: Pison

full_name: Christophe Pison

given: Christophe

family: Briault

full_name: Amandine Briault

given: Amandine

family: Downer

full_name: Nicola Downer

given: Nicola

name: Department of Interventional Pneumology, Ruhrlandklinik, West German Lung Center, University Clinic Essen, Essen, Germany

family: Darwiche

full_name: Kaid Darwiche

given: Kaid

name: Sheffield Teaching Hospitals, NHS Foundation Trust, Sheffield, United Kingdom

family: Rao

full_name: Jagan Rao

given: Jagan

name: Charité Universitätsmedizin Berlin, Medizinische Klinik m. Schw. Infektiologie und Pneumologie, Campus Virchow, Berlin, Germany

family: Hübner

full_name: Ralf-Harto Hübner

given: Ralf-Harto

family: Ruwwe-Glosenkamp

full_name: Christof Ruwwe-Glosenkamp

given: Christof

name: Service de Pneumologie et Réanimation, Unité d’Endoscopie Bronchique, Groupe Hospitalier Pitié Salpétrière, Paris, France

family: Trosini-Desert

full_name: Valéry Trosini-Desert

given: Valéry

name: Department of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg and Translational Lung Research Center Heidelberg, Heidelberg, Germany

family: Eberhardt

full_name: Ralf Eberhardt

given: Ralf

family: Herth

full_name: Felix J. Herth

given: Felix J.

name: Department of Pulmonary Diseases, Ghent University Hospital, Ghent, Belgium; and

family: Derom

full_name: Eric Derom

given: Eric

family: Malfait

full_name: Thomas Malfait

given: Thomas

family: Shah

full_name: Pallav L. Shah

given: Pallav L.

family: Garner

full_name: Justin L. Garner

given: Justin L.

name: Université Côte d’Azur, Centre Hospitalier Universitaire de Nice, FHU OncoAge, Service de Pneumologie, Nice, France

journal_name: American Journal of Respiratory and Critical Care Medicine

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

ReferenceCitation: Valipour A, Slebos DJ, Herth F, Darwiche K, Wagner M, Ficker JH, Petermann C, Hubner RH, Stanzel F, Eberhardt R; IMPACT Study Team. Endobronchial Valve Therapy in Patients with Homogeneous Emphysema. Results from the IMPACT Study. Am J Respir Crit Care Med. 2016 Nov 1;194(9):1073-1082.

ReferenceCitation: Klooster K, ten Hacken NH, Hartman JE, Kerstjens HA, van Rikxoort EM, Slebos DJ. Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation. N Engl J Med. 2015 Dec 10;373(24):2325-35. doi: 10.1056/NEJMoa1507807.

ReferenceCitation: Klooster K, Hartman JE, Ten Hacken NH, Slebos DJ. One-Year Follow-Up after Endobronchial Valve Treatment in Patients with Emphysema without Collateral Ventilation Treated in the STELVIO Trial. Respiration. 2017;93(2):112-121. doi: 10.1159/000453529. Epub 2016 Dec 15.

location_facility:
Hôpital Nord
Hôpital Dupuytren
Nouvel Hôpital Civil
Hôpital Bichat
Hôpital François Mitterrand
Hôpital La Cavale Blanche
Hôpital Charles Nicolle
Hôpital Arnaud de Villeneuve
Hôpital Cochin
Hôpital Calmette
Hôpital Larrey


type: Other Identifier

title: Assessment of Pain Through Parasympathetic Tone Analysis : Applicability in Children With Cerebral Palsy.

summary: This study evaluates Analgesia Nociception Index (Heart Rate Variability based index) and its variations after painful stimulations in children with cerebral palsy : acute procedural pain (botulinum toxin injections), and recurrent pain (physiotherapy).

status: Terminated

ReferenceCitation: Jeanne M, Delecroix M, De Jonckheere J, Keribedj A, Logier R, Tavernier B. Variations of the analgesia nociception index during propofol anesthesia for total knee replacement. Clin J Pain. 2014 Dec;30(12):1084-8. doi: 10.1097/AJP.0000000000000083.

ReferenceCitation: Jeanne M, Clément C, De Jonckheere J, Logier R, Tavernier B. Variations of the analgesia nociception index during general anaesthesia for laparoscopic abdominal surgery. J Clin Monit Comput. 2012 Aug;26(4):289-94. doi: 10.1007/s10877-012-9354-0. Epub 2012 Mar 28.

ReferenceCitation: De Jonckheere J, Rakza T, Logier R, Jeanne M, Jounwaz R, Storme L. Heart rate variability analysis for newborn infants prolonged pain assessment. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:7747-50. doi: 10.1109/IEMBS.2011.6091909.

ReferenceCitation: Faye PM, De Jonckheere J, Logier R, Kuissi E, Jeanne M, Rakza T, Storme L. Newborn infant pain assessment using heart rate variability analysis. Clin J Pain. 2010 Nov-Dec;26(9):777-82.

lead_sponsor: University Hospital, Lille

location_facility: CHRU de Lille, Pôle Enfant, Hôpital Roger Salengro

location_facility: Centre de Réadaptation Fonctionnelle Marc Sautelet

location_facility: Hôpital maritime de Zuydcoote, Service de SSR Enfant

intervention_type: Device


title: Evaluation of Diagnostic Performances of Esophageal Post Prandial High Resolution Impedance- Manometry (HRIM) in Patients With Gastro-esophageal Reflux Disease (GERD) Resistant to Proton Pump Inhibitor (PPI) Treatment : Pilot Study (MHR POST-PRANDIALE)

summary:
Nine to 30% of the population suffers from gastro-esophageal reflux disease (GERD) - suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat). Proton pump inhibitor (PPI) is usually the first line treatment. However 20 to 60% of patients have persistent symptoms on proton pump inhibitor. Complementary examinations are then required to determine the cause of persistent symptoms (non compliance to treatment, persistent esophageal acid exposure despite proton pump inhibitor, non acid reflux, reflux hypersensitivity, functional symptoms, rumination syndrome…). The gold standard to detect reflux episodes in patients on proton pump inhibitor therapy is 24-h ambulatory esophageal pH-impedance monitoring. Esophageal High Resolution Impedance-Manometry might help to determine gastro-esophageal reflux disease mechanisms especially when performed post prandially. Further some publications demonstrated that the number of reflux episodes detected during the post prandial period might be well correlated to the total number of reflux episodes recorded during 24 h.

The hypothesis of this study is that 1-hour post prandial esophageal High Resolution Impedance-Manometry might be useful to diagnose gastro-esophageal reflux disease and can replace in some instances 24-h esophageal pH-impedance monitoring. Therefore the aim is to compare the number of reflux episodes detected with esophageal High Resolution Impedance-Manometry performed during 1-h post prandial period to the total number of reflux episodes detected during 24-h ambulatory esophageal pH-impedance monitoring.

location_facility: Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot, Lyon, France


title: Clinical Trial on the Effect of Bezafibrate in the Muscular Form of Carnitine Palmitoyltransferase 2 Deficiency

summary: The purpose of this study is to determine whether bezafibrate is effective in the treatment of the muscular adult form of carnitine palmitoyltransferase 2 deficiency

design_allocation: Non-Randomized

intervention_type: Drug


title: Epidemiology and Clinical Characteristics of Non-Tuberculous Mycobacteria Infections in Cystic Fibrosis Patients.

acronym: CIMENT

summary:
An increase in the prevalence of infections due to non-tuberculous mycobacteria (NTM) is observed in many countries and recent data suggest the circulation of dominant clones with a possibility of human-to-human contamination. The hypothesis is made that these infections are also increasing in France and that dominant NTM clones are circulating. The last French study carried out in 2004 already showed prevalences of up to 10% in certain French regions. It is essential to know the prevalence 8 years later, taking advantage of the new recommendations for the management of patients and samples, which will homogenize practices on French territory.

No data are currently available in France on the prevalence of positive serological responses in cystic fibrosis patients. Serological analyzes of the sera collected during this study will enable us to evaluate the performance of serology in mycobacterial culture and to identify patients with no positive respiratory specimen in culture but with positive serology indicating potential contact with a mycobacterium. The establishment of a serological follow-up of these patients will allow to correlate this result with a clinical evolution and / or the detection of NTM in subsequent samples. Serology is an innovative aspect of the CIMENT study.

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceCitation: Qvist T, Gilljam M, Jönsson B, Taylor-Robinson D, Jensen-Fangel S, Wang M, Svahn A, Kötz K, Hansson L, Hollsing A, Hansen CR, Finstad PL, Pressler T, Høiby N, Katzenstein TL; Scandinavian Cystic Fibrosis Study Consortium (SCFSC). Epidemiology of nontuberculous mycobacteria among patients with cystic fibrosis in Scandinavia. J Cyst Fibros. 2015 Jan;14(1):46-52. doi: 10.1016/j.jcf.2014.08.002. Epub 2014 Aug 30.

ReferenceCitation: Albrecht C, Ringshausen F, Ott S, Wagner D, Rademacher J, Schneider M, Welte T, Pletz MW. Should all adult cystic fibrosis patients with repeated nontuberculous mycobacteria cultures receive specific treatment? A 10-year case-control study. Eur Respir J. 2016 May;47(5):1575-7. doi: 10.1183/13993003.01239-2015. Epub 2016 Feb 4.

ReferenceCitation: Griffith DE, Aksamit T, Brown-Elliott BA, Catanzaro A, Daley C, Gordin F, Holland SM, Horsburgh R, Huitt G, Iademarco MF, Iseman M, Olivier K, Ruoss S, von Reyn CF, Wallace RJ Jr, Winthrop K; ATS Mycobacterial Diseases Subcommittee; American Thoracic Society; Infectious Disease Society of America. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007 Feb 15;175(4):367-416. Review. Erratum in: Am J Respir Crit Care Med. 2007 Apr 1;175(7):744-5. Dosage error in article text.

ReferenceCitation: Martiniano SL, Sontag MK, Daley CL, Nick JA, Sagel SD. Clinical significance of a first positive nontuberculous mycobacteria culture in cystic fibrosis. Ann Am Thorac Soc. 2014 Jan;11(1):36-44. doi: 10.1513/AnnalsATS.201309-310OC.

ReferenceCitation: Floto RA, Olivier KN, Saiman L, Daley CL, Herrmann JL, Nick JA, Noone PG, Bilton D, Corris P, Gibson RL, Hempstead SE, Koetz K, Sabadosa KA, Sermet-Gaudelus I, Smyth AR, van Ingen J, Wallace RJ, Winthrop KL, Marshall BC, Haworth CS. US Cystic Fibrosis Foundation and European Cystic Fibrosis Society consensus recommendations for the management of non-tuberculous mycobacteria in individuals with cystic fibrosis: executive summary. Thorax. 2016 Jan;71(1):88-90. doi: 10.1136/thoraxjnl-2015-207983.

ReferenceCitation: Jeong BH, Kim SY, Jeon K, Lee SY, Shin SJ, Koh WJ. Serodiagnosis of Mycobacterium avium complex and Mycobacterium abscessus complex pulmonary disease by use of IgA antibodies to glycopeptidolipid core antigen. J Clin Microbiol. 2013 Aug;51(8):2747-9. doi: 10.1128/JCM.00702-13. Epub 2013 Jun 5.

ReferenceCitation: Qvist T, Taylor-Robinson D, Waldmann E, Olesen HV, Hansen CR, Mathiesen IH, Høiby N, Katzenstein TL, Smyth RL, Diggle PJ, Pressler T. Comparing the harmful effects of nontuberculous mycobacteria and Gram negative bacteria on lung function in patients with cystic fibrosis. J Cyst Fibros. 2016 May;15(3):380-5. doi: 10.1016/j.jcf.2015.09.007. Epub 2015 Oct 9.

ReferenceCitation: Qvist T, Pressler T, Taylor-Robinson D, Katzenstein TL, Høiby N. Serodiagnosis of Mycobacterium abscessus complex infection in cystic fibrosis. Eur Respir J. 2015 Sep;46(3):707-16. doi: 10.1183/09031936.00011815. Epub 2015 Apr 30.

lead_sponsor: University Hospital, Brest

location_facility:
CHR Sud Réunion
CHRU Brest
AP-HP Hôpital Foch
CHU Toulouse
AP-HP Hôpital Cochin
CHIC Créteil
CHU Bordeaux
Centre de Perharidy
CHU Tours
CHU Grenoble
CHU Lille
CHU Rouen
CHU Amiens
CHU Côte de Nacre


title: Self-help Program for Hypnotics Withdrawal in Chronic Insomniac Patients: A Randomized Controlled Clinical Trial

acronym: PROPERSOM

summary:
Persistent insomnia has a high prevalence in French general population affecting between 15.8 % and 19 % of adults. In France, the disease is mainly managed by general practitioners (GP) who usually proposed intermediate half-life benzodiazepines and Z-drugs in first-line treatment. French Health authorities recommend restricting the consumption of both hypnotics to no more than 4 weeks, considering their potential adverse effects (memory impairment, altered sleep physiology, motor-vehicle crash), and the risk of tolerance and dependence. However, it appears that a majority of patients become chronic users. Therefore, discontinuation of benzodiazepines/Z-drugs is recommended, but it may appear as a challenge due to withdrawal symptoms and psychological factors (anticipatory anxiety, fear of rebound insomnia).

Numerous studies have shown that programs based on Cognitive-Behavioural Therapy (CBT) principles improve sleep and daily life quality leading to hypnotic taper and maintain of hypnotic abstinence in insomniac patients. Cognitive-Behavioural Therapy (CBT) is based on 4 components: sleep restriction, stimulus control, cognitive therapy and sleep hygiene education. This therapy is dependent on a therapeutic alliance between practitioner and patient. Unfortunately, there are an insufficient number of trained CBT experts especially in France.

The implementation of an internet-delivered self-help program based on time-in-bed restriction and stimulus control may be an issue within the context of general practice.

Online programs based on CBT principles have been proved to be effective in improving the sleep and daytime functioning in this population, but the studies were realized in small patients groups.

Investigators hypothesis is that a simple and internet-delivered short-term program based on sleep restriction therapy and stimulus control (following to a GP consultation) may facilitate hypnotics discontinuation (benzodiazepines/Z-drugs) in patient with insomnia disorder still reporting sleep complaints in comparison with a tapering alone (no access to the self-help program).

primary_purpose: Supportive Care

ipd_sharing_description: Patient could request investigator an access to IPD according to French regulation (act No. 78-17 of 6 January 1978 on data processing, data files and individual liberties, amended by act No. 2004-801 of 6 August 2004).

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHRU de Lille
CHU de Bordeaux
APHP Hôtel-Dieu de Paris
CHU de Montpellier
APHP Hôpital Raymond Poincaré
AP-HP Hôpital Pitié-Salpétrière


title: TIPS (With Coated Stents) OR PARACENTESIS + ALBUMIN ADMINISTRATION FOR THE TREATMENT OF REFRACTORY ASCITES IN PATIENTS WITH CIRRHOSIS : A RANDOMIZED TRIAL COMPARING SURVIVAL, QUALITY OF LIFE AND NUTRITIONAL STATUS

summary: The main end point of the study is to assess survival in cirrhotic patients with refractory ascites treated by TIPS (using PTFE covered stents) vs patients treated by paracentesis + albumin infusion.

ReferenceCitation: Bureau C, Garcia-Pagan JC, Otal P, Pomier-Layrargues G, Chabbert V, Cortez C, Perreault P, Péron JM, Abraldes JG, Bouchard L, Bilbao JI, Bosch J, Rousseau H, Vinel JP. Improved clinical outcome using polytetrafluoroethylene-coated stents for TIPS: results of a randomized study. Gastroenterology. 2004 Feb;126(2):469-75.

ReferenceCitation: Bureau C, Thabut D, Oberti F, Dharancy S, Carbonell N, Bouvier A, Mathurin P, Otal P, Cabarrou P, Péron JM, Vinel JP. Transjugular Intrahepatic Portosystemic Shunts With Covered Stents Increase Transplant-Free Survival of Patients With Cirrhosis and Recurrent Ascites. Gastroenterology. 2017 Jan;152(1):157-163. doi: 10.1053/j.gastro.2016.09.016. Epub 2016 Sep 20. Erratum in: Gastroenterology. 2017 Sep;153(3):870.

family: Bureau

full_name: Christophe Bureau

family: Thabut

full_name: Dominique Thabut

given: Dominique

family: Oberti

full_name: Frédéric Oberti

given: Frédéric

family: Dharancy

full_name: Sébastien Dharancy

given: Sébastien

family: Carbonell

full_name: Nicolas Carbonell

given: Nicolas

family: Bouvier

full_name: Antoine Bouvier

given: Antoine

family: Mathurin

full_name: Philippe Mathurin

given: Philippe

family: Otal

full_name: Philippe Otal

family: Cabarrou

full_name: Pauline Cabarrou

given: Pauline

family: Péron

full_name: Jean Marie Péron

given: Jean Marie

family: Vinel

full_name: Jean Pierre Vinel

given: Jean Pierre

journal_name: Gastroenterology

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: University Hospital, Toulouse

location_facility: Service d'Hépato-Gastro-Entérologie, Hôpital Purpan


title: Study to Establish Patient-Matched Population Norms for the MS-COG

summary: The primary objective of the study is to develop MS patient-matched healthy population norms for the Multiple Sclerosis Cognition Assessment Battery (MS-COG) that are representative of the United States (US), France, and Italy.

lead_sponsor: Biogen

location_country:
Italy
United States
France

location_facility:
Research site
Research Site


title: Evaluation of a New Customized Removable Device With Rocker Sole for Plantar Off-Loading "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients

acronym: ORTHODIAB

summary:
Multi-center trial, randomized in 2 parallel groups, open label, with a blinded adjudication committee (PROBE methodology), comparing "Orthèse Diabète" with "conventional" removable devices in terms of healing of ulcers.

- Primary objective: Evaluate the efficiency of "Orthèse Diabète" compared to "conventional" removable devices, in terms of the proportion of diabetic patients whose principal ulcer will heal completely at 3 months.

ReferenceCitation: Malgrange D. [Physiopathology of the diabetic foot]. Rev Med Interne. 2008 Sep;29 Suppl 2:S231-7. doi: 10.1016/S0248-8663(08)73950-X. Review. French.

ReferenceCitation: Cavanagh PR, Lipsky BA, Bradbury AW, Botek G. Treatment for diabetic foot ulcers. Lancet. 2005 Nov 12;366(9498):1725-35. Review.

ReferenceCitation: Ramsey SD, Newton K, Blough D, McCulloch DK, Sandhu N, Reiber GE, Wagner EH. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999 Mar;22(3):382-7.

ReferenceCitation: Muller IS, de Grauw WJ, van Gerwen WH, Bartelink ML, van Den Hoogen HJ, Rutten GE. Foot ulceration and lower limb amputation in type 2 diabetic patients in dutch primary health care. Diabetes Care. 2002 Mar;25(3):570-4.

ReferenceCitation: Detournay B, Cros S, Charbonnel B, Grimaldi A, Liard F, Cogneau J, Fagnani F, Eschwège E. Managing type 2 diabetes in France: the ECODIA survey. Diabetes Metab. 2000 Nov;26(5):363-9.

ReferenceCitation: Detournay B, Raccah D, Cadilhac M, Eschwège E. Epidemiology and costs of diabetes treated with insulin in France. Diabetes Metab. 2005 Jun;31(3 Pt 2):3-18.

ReferenceCitation: Malgrange D, Richard JL, Leymarie F; French Working Group On The Diabetic Foot. Screening diabetic patients at risk for foot ulceration. A multi-centre hospital-based study in France. Diabetes Metab. 2003 Jun;29(3):261-8.

ReferenceCitation: Apelqvist J, Larsson J, Agardh CD. Long-term prognosis for diabetic patients with foot ulcers. J Intern Med. 1993 Jun;233(6):485-91.

ReferenceCitation: Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet. 2005 Nov 12;366(9498):1719-24. Review.

ReferenceCitation: Moxey PW, Hofman D, Hinchliffe RJ, Jones K, Thompson MM, Holt PJ. Epidemiological study of lower limb amputation in England between 2003 and 2008. Br J Surg. 2010 Sep;97(9):1348-53. doi: 10.1002/bjs.7092.

ReferenceCitation: Resnick HE, Carter EA, Sosenko JM, Henly SJ, Fabsitz RR, Ness FK, Welty TK, Lee ET, Howard BV; Strong Heart Study. Incidence of lower-extremity amputation in American Indians: the Strong Heart Study. Diabetes Care. 2004 Aug;27(8):1885-91.

ReferenceCitation: Fosse S, Hartemann-Heurtier A, Jacqueminet S, Ha Van G, Grimaldi A, Fagot-Campagna A. Incidence and characteristics of lower limb amputations in people with diabetes. Diabet Med. 2009 Apr;26(4):391-6. doi: 10.1111/j.1464-5491.2009.02698.x.

ReferenceCitation: Potier L, François M, Dardari D, Feron M, Belhatem N, Nobecourt-Dupuy E, Dolz M, Bordier L, Ducloux R, Chibani A, Eveno DF, Crea Avila T, Sultan A, Baillet-Blanco L, Rigalleau V, Gand E, Saulnier PJ, Velho G, Roussel R, Pellenc Q, Dupré JC, Malgrange D, Marre M, Mohammedi K; ORTHODIAB study group. Comparison of a new versus standard removable offloading device in patients with neuropathic diabetic foot ulcers: a French national, multicentre, open-label randomized, controlled trial. BMJ Open Diabetes Res Care. 2020 May;8(1). pii: e000954. doi: 10.1136/bmjdrc-2019-000954.

family: Potier

full_name: Louis Potier

given: Louis

family: François

full_name: Maud François

given: Maud

family: Dardari

full_name: Dured Dardari

given: Dured

family: Feron

full_name: Marilyne Feron

given: Marilyne

family: Belhatem

full_name: Narimene Belhatem

given: Narimene

family: Nobecourt-Dupuy

full_name: Estelle Nobecourt-Dupuy

given: Estelle

family: Dolz

full_name: Manuel Dolz

given: Manuel

family: Bordier

full_name: Lyse Bordier

given: Lyse

family: Ducloux

full_name: Roxane Ducloux

given: Roxane

family: Chibani

full_name: Abdelkader Chibani

given: Abdelkader

family: Eveno

full_name: Dominique-François Eveno

given: Dominique-François

family: Crea Avila

full_name: Teresa Crea Avila

given: Teresa

family: Sultan

full_name: Ariane Sultan

given: Ariane

family: Baillet-Blanco

full_name: Laurence Baillet-Blanco

given: Laurence

family: Rigalleau

full_name: Vincent Rigalleau

given: Vincent

family: Gand

full_name: Elise Gand

given: Elise

family: Saulnier

full_name: Pierre-Jean Saulnier

given: Pierre-Jean

family: Velho

full_name: Gilberto Velho

given: Gilberto

family: Roussel

full_name: Ronan Roussel

given: Ronan

family: Pellenc

full_name: Quentin Pellenc

given: Quentin

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

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

ReferenceCitation: Mohammedi K, Potier L, François M, Dardari D, Feron M, Nobecourt-Dupuy E, Dolz M, Ducloux R, Chibani A, Eveno DF, Crea Avila T, Sultan A, Baillet-Blanco L, Rigalleau V, Velho G, Tubach F, Roussel R, Dupré JC, Malgrange D, Marre M. The evaluation of off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) randomized controlled trial: study design and rational. J Foot Ankle Res. 2016 Aug 22;9(1):34. doi: 10.1186/s13047-016-0163-4. eCollection 2016.

title: The evaluation of off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) randomized controlled trial: study design and rationale


title: Feasibility and Performances of Spleen Stiffness Measurement as Surrogate Marker for Oesophageal Varices in Cirrhotic Patients.

summary:
FibroScan® (Echosens, Paris, France) is an active non implantable medical device marketed in Europe since December 2003 and is currently used in many countries. FibroScan® is an ultrasound-based vibration-controlled transient elastography (VCTE™) device dedicated to liver stiffness measurement (LSM).

Several clinical studies have shown the accuracy of LSM by FibroScan® to predict liver fibrosis.

Some other studies have already shown the good correlation between LSM, assessed by FibroScan® based on VCTE™ technology, and the presence of portal hypertension (PHT).

PHT is a clinical condition characterized by a high blood pressure in the portal vein and its tributaries and it is defined as a gradient between portal and systemic blood pressure > 6 mmHg.

The development of oesophageal varices (OV) in cirrhotic patients, as well as their potential bleeding, represent one of the most severe and life-threatening complication of cirrhosis.

Upper endoscopy is the best diagnostic tool for detecting the presence of OV, gastric varices or congestive gastropathy, for estimating the grade of OV and for the recognition of the presence of red color signs and wale marks or other indicators of high risk for bleeding.

However these two methods are quite invasive and associated with some risks; at the same time, not all cirrhotic patients present OV at endoscopic screening.

The aim of this study is the validation of SSM, assessed by a FibroScan® with acquisition parameters and algorithm optimized for SSM, as surrogate noninvasive marker for the presence of OV in liver cirrhosis patients.

primary_purpose: Diagnostic

ReferenceCitation: Stefanescu H, Marasco G, Calès P, Fraquelli M, Rosselli M, Ganne-Carriè N, de Ledinghen V, Ravaioli F, Colecchia A, Rusu C, Andreone P, Mazzella G, Festi D. A novel spleen-dedicated stiffness measurement by FibroScan® improves the screening of high-risk oesophageal varices. Liver Int. 2020 Jan;40(1):175-185. doi: 10.1111/liv.14228. Epub 2019 Sep 11.

name: Liver Unit Regional Institute of Gastroenterology and Hepatology Cluj‐Napoca Romania

family: Stefanescu

full_name: Horia Stefanescu

given: Horia

name: Department of Medical and Surgical Sciences University of Bologna Bologna Italy

family: Marasco

full_name: Giovanni Marasco

given: Giovanni

name: Hepato‐Gastroenterology Department University hospital Angers France

family: Calès

full_name: Paul Calès

given: Paul

name: Gastroenterology and Endoscopy Unit Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy

family: Fraquelli

full_name: Mirella Fraquelli

given: Mirella

name: Institute for Liver and Digestive Health Royal Free Hospital University College of London  London UK

family: Rosselli

full_name: Matteo Rosselli

given: Matteo

name: INSERM UMR 1162 Hepato‐Gastroenterology Department APHP Jean Verdier Hospital University Paris 13 Paris France

family: Ganne‐Carriè

full_name: Nathalie Ganne‐Carriè

given: Nathalie

name: Hepatology Department Haut‐Lévêque Hospital Bordeaux France

family: Ledinghen

full_name: Victor Ledinghen

given: Victor

family: Ravaioli

full_name: Federico Ravaioli

given: Federico

name: Gastroenterology Unit University Hospital Borgo Trento Verona Italy

family: Colecchia

full_name: Antonio Colecchia

given: Antonio

family: Rusu

full_name: Corina Rusu

given: Corina

family: Andreone

full_name: Pietro Andreone

given: Pietro

family: Mazzella

full_name: Giuseppe Mazzella

given: Giuseppe

family: Festi

full_name: Davide Festi

given: Davide

journal_name: Liver International

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: A novel spleen‐dedicated stiffness measurement by FibroScan® improves the screening of high‐risk oesophageal varices

lead_sponsor: Echosens

location_country:
Italy
Romania
United Kingdom
France

location_facility: Iuliu Hatieganu University of Medicine and Pharmacy

location_facility: Department of Clinical Medicine, Policlinico S. Orsola Malpighi

location_facility: Hôpital Haut-Lévêque, Service Hépato-gastroentérologie et Oncologie digestive

location_facility: Seconda Divisione di Gastroenterologia Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico,

location_facility: Hôpital Jean Verdier, Service Hépato-gastroentérologie


title: HEMOTOL: Effects of New Dialysis On-line Monitoring Devices on Hemodynamic Stability During Intermittent Hemodialysis in Critically Ill Patients With Acute Kidney Injury : a Prospective Randomized Study.

acronym: HEMOTOL

summary: The purpose of this randomized controlled study is to compare the effects of different new dialysis on-line monitoring devices on hemodynamic stability during intermittent hemodialysis in critically ill patients with acute kidney injury.

ReferenceCitation: du Cheyron D, Terzi N, Seguin A, Valette X, Prevost F, Ramakers M, Daubin C, Charbonneau P, Parienti JJ. Use of online blood volume and blood temperature monitoring during haemodialysis in critically ill patients with acute kidney injury: a single-centre randomized controlled trial. Nephrol Dial Transplant. 2013 Feb;28(2):430-7. doi: 10.1093/ndt/gfs124. Epub 2012 Apr 25.

family: du Cheyron

full_name: Damien du Cheyron

given: Damien

family: Terzi

full_name: Nicolas Terzi

given: Nicolas

family: Seguin

full_name: Amélie Seguin

given: Amélie

family: Valette

full_name: Xavier Valette

given: Xavier

family: Prevost

full_name: Fabrice Prevost

given: Fabrice

family: Ramakers

full_name: Michel Ramakers

given: Michel

family: Daubin

full_name: Cédric Daubin

given: Cédric

family: Charbonneau

full_name: Pierre Charbonneau

given: Pierre

family: Parienti

full_name: Jean-Jacques Parienti

given: Jean-Jacques

journal_name: Nephrology Dialysis Transplantation

evidence: open (via free pdf)

license_normalized: no license

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: University Hospital, Caen

location_facility: Service de Réanimation Médicale - CHU de Caen


title: Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

acronym: PROFIDYS

summary: This trial is intended to test the efficacy of an oral bisphosphonate (risedronate) to decrease bone pain and improve radiological aspect in fibrous dysplasia of bone.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_country: Germany Belgium France Netherlands

location_facility:
Leids Universitair Medisch Centrum
Heildeberg Clinical Centre
Cologne Clinical Centre
Hopital Cochin
Hopital Lariboisiere
Hospital Benjamin Franklin
Hopital E Herriot
Cliniques Universitaires Saint Luc


title: Improving the Participation Rate in ColoRectal Cancer Screening by Training General Practitioners in Motivational Interviewing

acronym: AMDepCCR

summary:
Colorectal cancer is the 2nd leading cause of cancer mortality in France. However this cancer is preventable in the majority of cases by early detection of adenomas.

In France, there is organized colorectal cancer screening, which relies on general practitioners (GPs). Tests delivered by GPs are performed in 89% of cases. However, GPs do not systematically offer the test, for time management and communication reasons. Patients expect their GPs to offer the test and to focus on their expectations. A previous study conducted on GPs showed that training in communication and motivational interviewing increases the number of tests performed by 12.2%.

In order to facilitate the promotion of screening, the investigators would like to develop a training programme for GPs focusing on the application of Motivational Interviewing (MI) techniques to the promotion of colorectal cancer screening.

Motivational Interviewing is a directive, client-centered counseling style for eliciting behavior change by helping clients to explore and resolve ambivalence.

This study is a multicenter trial in general medicine. In this randomized trial the 902 subjects will be included prospectively by the general practitioners (GP) participating in the study.

As a first step, general practitioners who have never participated in Motivational Interviewing training will be recruited and split into 2 groups by randomization, an intervention group and a control group. The interventional group will then undergo a 3 times 2-day training in Motivational Interviewing.

In a second step, the patients will be included by those GP and a self-questionnaire will be send at the inclusion and after 6, 12 and 24 months. The evaluation of the number of tests performed and the analyse of the Health Belief Model (HBM) self-questionnaire will be carried out.

At 24 months, there will be an evaluation of the denial motivation questionnaire for patients who have not participated in organized colorectal cancer screening.

ipd_sharing_description: All collected data that underlie results in a publication

location_facility:
Dr PERRIER
Dr PETIT
Dr BECK-ROBERT
Dr BARCELO
Dr BODIN
Dr MONFORT
Dr ATTENCOURT
Dr DESNOT
Dr MAGADUR
Dr LUCAS
Dr COLLETER
Dr VERBEQUE MORVAN
Dr BOUTERAON
Dr COUTURIER
Dr LOPIN
Dr DROGOU
Dr LEFEVRE
Dr JOLIVET COUTURE
Dr BARAIS
Dr LE GRIGNOU
Dr COGNEAU
Dr COROLLER
Dr MUNCK
Dr LE BOURHIS
Dr TREBAOL
Dr CHAPOIX
Dr ABALAIN
Dr KERGASTEL
Dr DENIEL
Dr DE LA SOUDIERE
Dr BLANCHARD
Dr LE FLOCH
Dr CRENN-CORVEZ
Dr BEURTON-COURAUD
Dr KERFRIDEN KERHOAS
Dr GASNIER
Dr HENRY
Dr PREVOT
Dr MAILLEUCHET
Dr OLIVIER
Dr KERVELLA
Dr PETTON-HILI
Dr VELLY
Dr POINOT
Dr AOUDIA
Dr BAUTA
Dr PITMAN
Dr GRALL
Dr PIPET-PENIN
Dr NICOLAS
Dr AUTRET
Dr VIALA
Dr DAOUDAL

intervention_type: Behavioral


title: Anti-Angiotensin II Type 1 Receptor Antibodies and Kidney Transplant Outcomes

summary:
Incompatibility between non-genetically identical donors and recipients has been increasingly recognized as the main contributing factor to solid allograft rejection and failure, through the triggering of donor-specific responses mediated by T- and B-lymphocytes. The Human Leucocyte Antigen (HLA) system has been identified as the main target of donor-specific responses, especially through the production by the recipient of antibodies directed toward non-self donor HLA molecules expressed on the allograft endothelium. As a consequence, in organ transplantation, the current approach to immunological risk stratification, patient monitoring and rejection diagnosis is based on biomarkers derived from the HLA system. However, this approach does not provide a sufficient accuracy for the risk stratification and the diagnosis of immunological complications in solid organ transplantation, which still remain the dominant cause of allograft failure.

A recent body of evidence supports that specific non-HLA antigens expressed on the allograft endothelium may be relevant to allograft rejection, suggesting that a new strategy to transplant diagnostic testing at a non-HLA level would help to overcome the limitations of the current HLA-based approach to immunological assessment of transplant recipients. Among antibodies to non-HLA endothelial antigens, angiotensin II type 1 receptor activating antibodies have been the most widely reported antibodies to associate with the occurrence of allograft rejection, dysfunction and loss, even if their independent role, with respect to the presence of concomitant anti-HLA antibodies, has not been demonstrated.

lead_sponsor: Paris Translational Research Center for Organ Transplantation

location_facility: Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France

location_facility: Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France


title: Gentamicine-EDTA, a New Anti-biofilm Strategy for the Conservative Treatment of Catheter-related Infections

acronym: CATH-GE

summary: Catheter-related infections are frequent. Treatment without catheter removal is difficult because of the presence of biofilm. The association of gentamicin and EDTA is active in vitro and in vivo against biofilms formed by Gram positive and Gram negative bacteria.

lead_sponsor: Institut Pasteur

location_facility:
HEGP
Hôpital Henri Mondor
Hôpital Saint-Louis


title: CORIMUNO19-ECU: Trial Evaluating Efficacy and Safety of Eculizumab (Soliris) in Patients With COVID-19 Infection, Nested in the CORIMUNO-19 Cohort

summary: The overall objective of the study is to determine the therapeutic effect and tolerance of Eculizumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Eculizumab is a terminal complement inhibitor that has been investigated for more than 10 years in numerous complement-mediated diseases. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Eculizumab administration to patients enrolled in the CORIMUNO-19 cohort. Eculizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Eculizumab will receive standard of care. Outcomes of Eculizumab-treated patients will be compared with outcomes of standard of care-treated patients as well as with outcomes of patients treated with other immune modulators.

location_facility:
Saint Louis
saint Louis
Réanimation médicale


title: Prospective Multicentric Study of Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients

acronym: OPTIREG

summary:
Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality. However, one-third of patients are non-responders. Among factors associated with non-response, suboptimal electrical settings of the device, i.e. inadequate pacing vector selection and atrioventricular (AV) delay, is an important cause.

The aim of the study is to investigate whether the optimization of CRT settings (pacing vector and AV delay) results in improved clinical and echocardiographic outcomes in a non-responder CRT population after 6 months of therapy.

lead_sponsor: CMC Ambroise Paré

location_facility:
CHU de Poitiers
CMC Ambroise Paré
GHEM Eaubonne


title: Observational and Transversal Study of Patients Treated in "Real Life"Conditions With Adaptive Servo-Ventilation

acronym: OTRLASV

summary: Adaptive Servo-Ventilation (ASV) treatment is routinely prescribed in France. In order to be reimbursed according to the French Social Security rules, the patient treated with an ASV needs to be examined each year. In this observational transversal single-visit study, the investigators aim to describe the clinical characteristics of patients treated with ASV and the associated device settings.

ReferenceType: result

ReferenceCitation: Jaffuel D, Philippe C, Rabec C, Mallet JP, Georges M, Redolfi S, Palot A, Suehs CM, Nogue E, Molinari N, Bourdin A. What is the remaining status of adaptive servo-ventilation? The results of a real-life multicenter study (OTRLASV-study) : Adaptive servo-ventilation in real-life conditions. Respir Res. 2019 Oct 29;20(1):235. doi: 10.1186/s12931-019-1221-9.

family: Jaffuel

full_name: Dany Jaffuel

given: Dany

family: Philippe

full_name: Carole Philippe

given: Carole

family: Rabec

full_name: Claudio Rabec

given: Claudio

family: Mallet

full_name: Jean-Pierre Mallet

given: Jean-Pierre

family: Georges

full_name: Marjolaine Georges

given: Marjolaine

family: Redolfi

full_name: Stefania Redolfi

given: Stefania

family: Palot

full_name: Alain Palot

given: Alain

family: Suehs

full_name: Carey M. Suehs

given: Carey M.

family: Nogue

full_name: Erika Nogue

given: Erika

family: Molinari

full_name: Nicolas Molinari

family: Bourdin

full_name: Arnaud Bourdin

given: Arnaud

currency_apc_doaj: GBP

journal_name: Respiratory Research

evidence: oa repository (via pmcid lookup)

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repositories:
HAL
PubMed Central

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

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Jaffuel D, Rabec C, Philippe C, Mallet JP, Georges M, Redolfi S, Palot A, Suehs CM, Nogue E, Molinari N, Bourdin A. Patterns of adaptive servo-ventilation settings in a real-life multicenter study: pay attention to volume! : Adaptive servo-ventilation settings in real-life conditions. Respir Res. 2020 Sep 21;21(1):243. doi: 10.1186/s12931-020-01509-7.

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

ReferenceCitation: Jaffuel D, Mallet JP, Combes N, Palot A, Rabec C, Molinari N, Jaber S, Bourdin A. [Adaptive servo-ventilation after the SERVE-HF study: The swan song?]. Rev Mal Respir. 2016 Sep;33(7):641-4. doi: 10.1016/j.rmr.2016.04.001. Epub 2016 May 5. French.

title: La ventilation auto-asservie après SERVE-HF : le chant du cygne ?

location_facility: Arnaud de Villeneuve University Hospital


type: Other Grant/Funding Number

title: Pressure Therapy in the Treatment of Upper Arm of Cerebral Palsy Children

acronym: PROPENSIX

summary: The purpose of this study is to assess the efficacy of a 6 months upper arm proprioceptive pressure therapy on Assisting Hand Assessment ("AHA") performance in Cerebral Palsy (CP). To perform this study, 80 CP patients aged of 5 to 10 years old will be included in a multicentric, double blind, prospective parallel-group randomized study. Treatment will be a pressure therapy using a LYCRA® compressive sleeve initially used in burn therapy. Primary outcome is to increase of 60% of AHA performance. The secondary outcome are to increase Quality of Upper Extremity Skill Test (QUEST), quality of life and improve Somatosensory Evoked Potentials (SEP).

location_facility: Service d'Education et de Soins Spécialisés à domicile_APF de Creil

location_facility: Centre de Soins de Suite et de Réadaptation Pédiatrique Spécialisé_Centre Paul Dottin


title: Interest of Systematic Tracking of Dementia Cases in Nursing Homes: Analysing the Contribution of MultiDisciplinary Team Meeting (MDTM) in Alzheimer's Disease and Related Diseases

acronym: IDEM

summary:
Introduction: Epidemiological data show that in France only half of patients with Alzheimer disease are currently diagnosed in the general population. The absence of early diagnosis of dementia reduces the opportunities of patients to receive optimal care. One of the consequences of undiagnosed dementia is inadequate use of emergency care units.

The main objective: The main aim of this study is to evaluate the impact of a systematic case-finding procedure of dementia cases in nursing homes through a MDTM on the rate of hospitalization in emergency care units.

Secondary objectives:

To assess the impact of systematic tracking of dementia cases on the:

Quantity and quality of drug-prescription
Appropriateness of hospitalizations
Prevalence of neuropsychiatric symptoms
Dependency
Quality of life
Burden of nursing staff working conditions
Planning of specific therapeutic measures
Overall health care costs

primary_purpose: Prevention

ReferenceCitation: Rolland Y, Tavassoli N, de Souto Barreto P, Perrin A, Laffon de Mazières C, Rapp T, Hermabessière S, Tournay E, Vellas B, Andrieu S. Systematic Dementia Screening by Multidisciplinary Team Meetings in Nursing Homes for Reducing Emergency Department Transfers: The IDEM Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Feb 5;3(2):e200049. doi: 10.1001/jamanetworkopen.2020.0049.

name: Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France

name: Équipe Régionale Vieillissement et Prévention de la Dépendance (ERVPD), Gérontopôle de Toulouse, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France

name: UMR 1027, INSERM–Université de Toulouse III, Toulouse, France

family: Rolland

full_name: Yves Rolland

given: Yves

family: Tavassoli

full_name: Neda Tavassoli

given: Neda

family: de Souto Barreto

full_name: Philipe de Souto Barreto

given: Philipe

family: Perrin

full_name: Amélie Perrin

given: Amélie

family: Laffon de Mazières

full_name: Clarisse Laffon de Mazières

given: Clarisse

name: LIRAES (EA 4470) & Chaire AGEINOMIX, Université Paris Descartes Sorbonne Paris Cité, Paris, France

family: Rapp

full_name: Thomas Rapp

given: Thomas

family: Hermabessière

full_name: Sophie Hermabessière

given: Sophie

family: Tournay

full_name: Elodie Tournay

given: Elodie

family: Vellas

full_name: Bruno Vellas

given: Bruno

name: Service d'Epidémiologie, Unité de Soutien Méthodologique à la Recherche, Centre Hospitalier Universitaire de Toulouse, Toulouse, France

family: Andrieu

full_name: Sandrine Andrieu

given: Sandrine

journal_name: JAMA Network Open

location_facility: Ehpad Et. Public Gerontologie de Marines

location_facility: Ehpad Maison Retraite Orelia Ch St Gaudens

location_facility: Ehpad Maison de Retraite "Les Charmilles"

location_facility: Ehpad Residence Borde Haute Promo-Accueil

location_facility: Ehpad Maison de Retraite Hl Ax Les Thermes

location_facility: Centre de Gerontologie Pompeyrie Chu Agen

location_facility: Ehpad Maison de Retraite Privee de Mazeres

location_facility: AP-HP Hôpital Necker Enfants Malades Service d'endocrinologie pédiatrique - 149 route de Sèvres

location_facility: AP-HM Hôptal La Timone Service de Pédiatrie Mutidisciplinaire

location_facility: Ehpad Maison de Retraite Chic Tarbes Vic


title: Evaluation of an 3D Imaging Intensifier Coupled to a Navigation Station in the Surgery of the Spine and Pelvis

acronym: FLUORONAV

summary: The purpose of this study is to demonstrate an optimization of the establishment of orthopedic implants in surgery of the spine and pelvic ring by combining 3D fluoroscopy and navigation system versus conventional method involving anatomical landmarks and 2D fluoroscopy.

lead_sponsor: AdministrateurCIC

location_facility: Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France


title: "ShearWave" Elastography Interest in the Management of Thyroid Nodules

acronym: SWETHY

summary: Define an ultrasound/elastography benignity criteria in strategy management of a patient population carries one or more thyroid nodules.


type: EudraCT Number

title: Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder

summary: The purpose of this study will be to demonstrate improvement of the T regulatory cells (Treg) response, under add on low-dose Interleukin 2 (ld-IL2) in patients with bipolar disorders experiencing a depressive relapse


title: Organisation PERiopératoire de l'anesthésie et de la Chirurgie Ambulatoire

acronym: OPERA

summary: In France, there are no precise data regarding perioperative organization of medical structure and care management of ambulatory surgical patients. Particularly, data on management of pain, nausea and vomiting, as well as venous thromboembolic, prevention and treatment are needed, in several groups of patients.

ReferenceCitation: Clergue F, Auroy Y, Péquignot F, Jougla E, Lienhart A, Laxenaire MC. [Anesthesia in France in 1996. Results of a study of the French Society of Anesthesia and Resuscitation]. Chirurgie. 1999 Apr;124(2):115-21. French.

ReferenceCitation: Clergue F, Auroy Y, Péquignot F, Jougla E, Lienhart A, Laxenaire MC. French survey of anesthesia in 1996. Anesthesiology. 1999 Nov;91(5):1509-20.

ReferenceCitation: Lienhart A, Auroy Y, Clergue F, Laxenaire MC, Péquignot F, Jougla E. [Anesthetics and transfusion practices]. Ann Fr Anesth Reanim. 1998;17(11):1374-86. French.

ReferenceCitation: Aubrun F, Ecoffey C, Benhamou D, Jouffroy L, Diemunsch P, Skaare K, Bosson JL, Albaladejo P. Perioperative pain and post-operative nausea and vomiting (PONV) management after day-case surgery: The SFAR-OPERA national study. Anaesth Crit Care Pain Med. 2019 Jun;38(3):223-229. doi: 10.1016/j.accpm.2018.08.004. Epub 2018 Oct 16.

family: Aubrun

full_name: Frédéric Aubrun

given: Frédéric

family: Ecoffey

full_name: Claude Ecoffey

given: Claude

family: Benhamou

full_name: Dan Benhamou

given: Dan

family: Jouffroy

full_name: Laurent Jouffroy

given: Laurent

family: Diemunsch

full_name: Pierre Diemunsch

given: Pierre

family: Skaare

full_name: Kristina Skaare

given: Kristina

family: Bosson

full_name: Jean Luc Bosson

given: Jean Luc

family: Albaladejo

full_name: Pierre Albaladejo

journal_name: Anaesthesia Critical Care & Pain Medicine

oa_colors: green other

evidence: open (author manuscript)

version: acceptedVersion

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

lead_sponsor: University Hospital, Grenoble

location_facility: Centre Hospitalier Bretagne Atlantique site de Vannes

location_facility: Clinique de Flandre - Coudekerque Branche

location_facility: Centre Hospitalier Saint-Cyr- Villeneuve sur Lot

location_facility: Centre hospitalier Henri Mondor d'Aurillac

location_facility: Centre Hospitalier de Bretagne Sud site Bodelio

location_facility: Centre de Chirurgie Abulatoire des Hauts d'Avignon

location_facility: CH National d'Ophtalmologie - les quinze vingts


title: Efficacy of Antibiotic Short Course for Bloodstream Infections in Acute Myeloid Leukemia Patients With Febrile Neutropenia: a Retrospective Comparative Study

summary: There is no specific recommendation about antimicrobial treatment length for documented infections in chemotherapy induced febrile neutropenia. The aim of this study was to compare long versus short antibiotic course for bloodstream infection treatment in acute myeloid leukemia patients during febrile neutropenia. This monocentric retrospective comparative study included all consecutive bloodstream infection episodes among acute myeloid leukemia patients with febrile neutropenia for 3 years (2017-2019). Episodes were classified regarding the length of antibiotic treatment, considered as short course if the treatment lasted ≤7 days, except for nonfermenting bacteria and Staphylococcus aureus or lugdunensis for which the threshold was ≤10 days and ≤14 days, respectively. The primary outcome was the number of bloodstream infection relapses in both groups within 30 days of antibiotic discontinuation.

lead_sponsor: Poitiers University Hospital


title: Prevalence of Right Ventricular Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases and Its Impact on Outcomes

acronym: DVD

summary: Observational study in patients with chronic respiratory diseases (chronic obstructive pulmonary diseases, bronchiectasis, interstitial lung diseases, neuromuscular diseases, obesity-hypoventilation syndrome...) admitted in intensive care unit for acute respiratory failure. The main objective is to determine the prevalence of right ventricular (RV) dysfunction in this population and to analyze the impact of such a complication on outcomes (survival at day-28, duration of non-invasive or mechanical ventilation, duration of hospital stay). RV function will be assessed by echocardiography at admission, after 3 days and at discharge. Plasma NT-proBNP and troponin levels will be collected.

lead_sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

location_facility: Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière Paris, France


title: Feasibility and Validity of an Observational Scale as a Surrogate of Dyspnea in Non-communicating Patients in the Intensive Care Unit (ICU): DYS-NOC

acronym: DYS-NOC

summary:
Background : Dyspnea is common and severely impact mechanically ventilated patients outcomes in intensive care unit (ICU). Recognize, measure and treat dyspnea have become current major therapeutic challenge. Its measurement involves a self-assessment by the patient, and by definition, a certain level of communication. Consequently, a large proportion of the ICU-population (non-communicating) misses its evaluation and potential benefits associated with its control. In other hand, electrophysiological markers that help to detect and quantify dyspnea regardless of the patient's cooperation, has been developed and validated as dyspnea surrogate, namely: 1) the electromyographic (EMG) activity of extra diaphragmatic inspiratory muscles and 2) the premotor inspiratory potentials (PIP) detected on the electroencephalogram (EEG). Because of its complex implementation in daily practice the research team has developed alternatively a behavioral score called IC-RDOS that provides reliable dyspnea assessment also without patient participation. Validated in conscious patients, it has not been yet validated in non-communicating patients.

Hypothesis : The IC-RDOS is valid for non-communicating ventilated patients and allows a simple and reliable assessment of dyspnea in this specific population.

Objective : To validate the IC-RDOS in non-communicating ICU patients under mechanical ventilation, using comparison with the tools validated for reliable measure of dyspnea in non-communicating patients (EMG, EEG).

Patients and Methods: In 40 patients will be collected simultaneously IC-RDOS, PIP (EEG) and electromyographic activity of three extra diaphragmatic inspiratory muscles (scalene, parasternal and Alae nasi) before and after intervention therapy aiming at reduce dyspnea (ventilator settings or pharmacological intervention), initiated by the clinician in charge of the patient.

Expected results : Observe a strong positive correlation between the IC-RDOS and electrophysiological markers (amplitude of the electromyogram and presence and magnitude of PIP). Observe a correlation between changes in the IC-RDOS and the electrophysiological markers after therapeutic interventions.

Optimizing patient comfort is a prominent concern in the ICU. By optimizing the detection and quantification of dyspnea in non-communicating patients, this study should ultimately improve the management and "the better living" of ventilated patients in intensive care

ReferenceCitation: Lansing RW, Gracely RH, Banzett RB. The multiple dimensions of dyspnea: review and hypotheses. Respir Physiol Neurobiol. 2009 May 30;167(1):53-60. doi: 10.1016/j.resp.2008.07.012. Epub 2008 Jul 25. Review.

family: Lansing

full_name: Robert W. Lansing

given: Robert W.

family: Gracely

full_name: Richard H. Gracely

given: Richard H.

family: Banzett

full_name: Robert B. Banzett

given: Robert B.

journal_name: Respiratory Physiology & Neurobiology

oa_host_type: repository

title: The multiple dimensions of dyspnea: Review and hypotheses

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family: Kessler

full_name: R. Kessler

given: R.

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full_name: M. R. Partridge

given: M. R.

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full_name: M. Miravitlles

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given: C.

family: Leynaud

full_name: D. Leynaud

given: D.

family: Ostinelli

full_name: J. Ostinelli

given: J.

journal_name: European Respiratory Journal

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

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given: J. M.

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publisher: Ovid Technologies (Wolters Kluwer Health)

title: Dyspnea in mechanically ventilated critically ill patients*

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name: Department of Nursing Administration, Detroit Receiving Hospital, Detroit, Michigan.

name: College of Nursing, Wayne State University, Detroit, Michigan.

name: Palliative Care Service, Detroit Receiving Hospital, Detroit, Michigan.

title: A Respiratory Distress Observation Scale for Patients Unable To Self-Report Dyspnea

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name: From the AP-HP, Groupe Hospitalier Pitié-Salpêtrière-Charles Foix, Service de Pneumologie et Réanimation Médicale (Département “R3S”), Paris, France (R.P., M.S., J.M., A.D., C.M.-P., T.S.); AP-HP, Groupe Hospitalier Pitié-Salpêtrière-Charles Foix, Pôle Biologie Médicale et Pathologie, Service de Parasitologie et Mycologie, Paris, France (F.G.); Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1158

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title: Development and Validation of Indicators on the Appropriateness of Oral Anticoagulant Prescriptions in Adult Medicine Automated From the Hospital Information System (PACHA Study).

acronym: PACHA

summary: This research focuses on the development and validation of indicators on the appropriateness of oral anticoagulant prescriptions. The investigators want to propose transferable tools to other healthcare institutions to allow automated construction of indicators as part of a structured approach to improve future practices. The main objective of the study is to develop indicators on the appropriateness of oral anticoagulant prescriptions in adult medicine automated from the hospital information system and to assess their criterion validity.

ReferenceCitation: Petit-Monéger A, Thiessard F, Noize P, Berdaï D, Jouhet V, Saillour-Glénisson F, Salmi LR; PACHA research group. Definition of indicators of the appropriateness of oral anticoagulant prescriptions in hospitalized adults: Literature review and consensus (PACHA study). Arch Cardiovasc Dis. 2018 Mar;111(3):155-171. doi: 10.1016/j.acvd.2017.05.005. Epub 2017 Sep 21. Review.

family: Petit-Monéger

full_name: Aurélie Petit-Monéger

given: Aurélie

family: Thiessard

full_name: Frantz Thiessard

given: Frantz

family: Noize

full_name: Pernelle Noize

given: Pernelle

family: Berdaï

full_name: Driss Berdaï

given: Driss

family: Jouhet

full_name: Vianney Jouhet

given: Vianney

family: Saillour-Glénisson

full_name: Florence Saillour-Glénisson

given: Florence

family: Salmi

full_name: Louis-Rachid Salmi

given: Louis-Rachid

journal_name: Archives of Cardiovascular Diseases

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Petit-Monéger A, Thiessard F, Jouhet V, Noize P, Berdaï D, Kret M, Sitta R, Salmi LR, Saillour-Glénisson F; PACHA research group. Development and validation of hospital information system-generated indicators of the appropriateness of oral anticoagulant prescriptions in hospitalised adults: the PACHA study protocol. BMJ Open. 2017 Aug 31;7(8):e016488. doi: 10.1136/bmjopen-2017-016488.

family: Kret

full_name: Marion Kret

given: Marion

family: Sitta

full_name: Rémi Sitta

given: Rémi

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

location_facility: Hôpital européen Georges-Pompidou - Département d'informatique Hospitalière

location_facility: CHU de Rennes - Service d'information médicale

location_facility: Service d'Information Médicale, Unité d'Informatique et d'Archivistique Médicale (UIAM)


title: Rapid Detection of Rifampin and Isoniazid Resistance by PCR Before Tuberculosis (TB) Treatment Initiation: a National Multicenter Randomized Clinical Trial

acronym: FAST-TB

summary:
French guidelines currently recommend to initiate a 4-drug containing regimen associating isoniazid (INH or H), rifampicin (RIFor RMP or R), pyrazinamide (PZA or Z) and ethambutol (EMB or E) pending the results of drug susceptibility testing (DST). The rationale behind routine use of EMB is to prevent the emergence of resistance to rifampicin (RMP), in case of primary resistance to INH. Hence, early detection of resistance to INH and RIF using molecular testing in Mycobacterium tuberculosis could allow early adaptation of antituberculosis treatment: i) start with a 3-drug containing regimen (i.e. INH, RIF, and PZA); ii) early enforcement of treatment when resistance is suspected, pending in depth susceptibility testings.

the duration of treatment is 6 months or 12 months.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Bichat Claude Bernard Hospital
Bichat hospital