title: A Phase IIa Multi-Center, Randomized, Single-Blind Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplantation

summary: This is a Phase II prospective, multi-center, single-blind, randomized clinical trial of safety in the treatment of BOS 1 in adult recipients of an allogeneic hematopoetic stem cell transplant. Twenty-four patients are planned for enrollment. The clinical trial will be conducted in approximately 20 centers in Germany, France, and Spain. Patients will be randomly allocated 1:1:1 to receive either L-CsA (10 mg bid or 5 mg bid) plus Standard of Care, or liposomal placebo plus Standard of Care. Investigational Medicinal Product will be administered for up to 12 weeks.

lead_sponsor: Zambon SpA

location_country: Germany France Spain

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Hospital Clinico Universitario de Valencia


title: Comparison of Melphalan-Prednisone(MP),MP-THALIDOMIDE,and Autologous Stem Cell Transplantation in the Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma.

summary: In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used since the 1960s and is regarded as the standard of care in elderly patients. We assess whether the addition of thalidomide to this combination or adapted high-dose chemotherapy, using a melphalan 100 mg/m2 -based regimen, would improve survival.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, Renaud M, Harousseau JL, Guillerm G, Chaleteix C, Dib M, Voillat L, Maisonneuve H, Troncy J, Dorvaux V, Monconduit M, Martin C, Casassus P, Jaubert J, Jardel H, Doyen C, Kolb B, Anglaret B, Grosbois B, Yakoub-Agha I, Mathiot C, Avet-Loiseau H; Intergroupe Francophone du Myélome. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007 Oct 6;370(9594):1209-18.

lead_sponsor: University Hospital, Lille

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: Pharmacokinetic/Pharmacodynamic Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora

summary: Bacterial resistance to antibiotics has been a growing therapeutic problem since the late 1980s. Resistant strains of pathogenic bacteria can arise through initial selection of resistant strains in the commensal flora. The emergence of fluoroquinolone resistance in the commensal flora will be assessed in 48 healthy volunteers receiving variable doses of ciprofloxacin during 14 days. Emergence of resistance will be correlated to pharmacokinetic characteristics of ciprofloxacin.

status: Terminated

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceCitation: de Lastours V, Maugy E, Mathy V, Chau F, Rossi B, Guérin F, Cattoir V, Fantin B; CIPHARES Study Group. Ecological impact of ciprofloxacin on commensal enterococci in healthy volunteers. J Antimicrob Chemother. 2017 Jun 1;72(6):1574-1580. doi: 10.1093/jac/dkx043.

name: IAME, UMR-1137, Inserm and Université Paris Diderot, Paris, France

name: Service de Médecine Interne, Hôpital Beaujon, APHP, Paris, France

family: de Lastours

full_name: Victoire de Lastours

given: Victoire

sequence: first

name: Université de Caen Normandie, EA4655 (équipe ‘Antibio-Résistance’), Caen, France

family: Maugy

full_name: Elena Maugy

given: Elena

sequence: additional

family: Mathy

full_name: Vincent Mathy

given: Vincent

family: Chau

full_name: Françoise Chau

given: Françoise

family: Rossi

full_name: Benjamin Rossi

given: Benjamin

name: CNR de la Résistance aux Antibiotiques (Laboratoire Associé ‘Entérocoques’), Caen, France

family: Guérin

full_name: François Guérin

given: François

family: Cattoir

full_name: Vincent Cattoir

family: Fantin

full_name: Bruno Fantin

given: Bruno

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Antimicrobial Chemotherapy

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: de Lastours V, Cambau E, Guillard T, Marcade G, Chau F, Fantin B. Diversity of individual dynamic patterns of emergence of resistance to quinolones in Escherichia coli from the fecal flora of healthy volunteers exposed to ciprofloxacin. J Infect Dis. 2012 Nov;206(9):1399-406. doi: 10.1093/infdis/jis511. Epub 2012 Aug 28.

full_name: V. de Lastours

given: V.

family: Cambau

full_name: E. Cambau

given: E.

family: Guillard

full_name: T. Guillard

given: T.

family: Marcade

full_name: G. Marcade

given: G.

full_name: F. Chau

given: F.

full_name: B. Fantin

given: B.

journal_name: Journal of Infectious Diseases

title: Diversity of Individual Dynamic Patterns of Emergence of Resistance to Quinolones in Escherichia coli From the Fecal Flora of Healthy Volunteers Exposed to Ciprofloxacin

ReferenceCitation: Fantin B, Duval X, Massias L, Alavoine L, Chau F, Retout S, Andremont A, Mentré F. Ciprofloxacin dosage and emergence of resistance in human commensal bacteria. J Infect Dis. 2009 Aug 1;200(3):390-8. doi: 10.1086/600122.

family: Duval

full_name: Xavier Duval

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

title: Ciprofloxacin Dosage and Emergence of Resistance in Human Commensal Bacteria

location_facility: Hôpital Bichat Claude Bernard, 46 rue Henri Huchard


title: Development of a Predictive Score for Local Complications of Femoral Bifurcation Surgery: Prospective Multicenter Cohort Study

acronym: PROFA

summary:
No prospective study has yet evaluated the factors influencing the complications of femoral bifurcation surgery in France. Daily practice of investigators suggests that conventional surgical treatment has had a higher rate of local complications in recent years for a variety of reasons that remain to be assessed (aging, overweight, chronic renal failure, diabetes, or other), but as of yet, investigators do not have proof of such an effect. The proposed study would follow a prospective, continuous, multicentre cohort of patients to describe the type, frequency and factors that contribute to local and general complications of surgery on the femoral bifurcation. This information is essential in the choice of the best revascularization technique for the femoral artery, which is frequently the site used for interventions in vascular conditions.

Surgeries will be performed in the normal manner. The research will be based on medical data collected during patient management. A measurement of the incision/scar will be taken once the procedure has been performed, either immediately after surgery or after a period of time, during post-operative consultation. Participation in this research will last 3 months from the day of the intervention.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU Dijon Bourgogne
CH Colmar
CHU Jean Minjoz
GHR Mulhouse
CH Troyes
CHU Nancy
CH Mâcon

intervention_type: Other

status_simplified: Ongoing


title: Cohort of Patients Naive of Antiretroviral Treatment at Enrollment

acronym: COPANA

summary: The purpose of this study is to evaluate the short, medium and long-term prognosis for newly diagnosed HIV patients.

ReferenceType: background

ReferenceCitation: Boufassa F, Goujard C, Viard JP, Carlier R, Lefebvre B, Yeni P, Bouchaud O, Capeau J, Meyer L, Vigouroux C; ANRS COPANA Cohort Study Group. Immune deficiency could be an early risk factor for altered insulin sensitivity in antiretroviral-naive HIV-1-infected patients: the ANRS COPANA cohort. Antivir Ther. 2012;17(1):91-100. doi: 10.3851/IMP1916.

ReferenceCitation: Dray-Spira R, Legeai C, Le Den M, Boué F, Lascoux-Combe C, Simon A, May T, Goujard C, Meyer L; ANRS-COPANA Cohort Study Group. Burden of HIV disease and comorbidities on the chances of maintaining employment in the era of sustained combined antiretoviral therapies use. AIDS. 2012 Jan 14;26(2):207-15. doi: 10.1097/QAD.0b013e32834dcf61.

ReferenceCitation: Rachas A, Warszawski J, Le Chenadec J, Legeai C, Teglas JP, Goujard C, Rouzioux C, Mandelbrot L, Tubiana R, Meyer L. Does pregnancy affect the early response to cART? AIDS. 2013 Jan 28;27(3):357-67. doi: 10.1097/QAD.0b013e32835ac8bc.

family: Rachas

full_name: Antoine Rachas

given: Antoine

family: Warszawski

full_name: Josiane Warszawski

given: Josiane

family: Le Chenadec

full_name: Jérôme Le Chenadec

given: Jérôme

family: Legeai

full_name: Camille Legeai

given: Camille

family: Teglas

full_name: Jean-Paul Teglas

given: Jean-Paul

family: Goujard

full_name: Cécile Goujard

given: Cécile

family: Rouzioux

full_name: Christine Rouzioux

given: Christine

family: Mandelbrot

full_name: Laurent Mandelbrot

given: Laurent

family: Tubiana

full_name: Roland Tubiana

given: Roland

family: Meyer

full_name: Laurence Meyer

given: Laurence

journal_name: AIDS

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Krastinova E, Seng R, Yeni P, Viard JP, Vittecoq D, Lascoux-Combe C, Fourn E, Pahlavan G, Delfraissy JF, Goujard C, Meyer L; ANRS PRIMO and COPANA Cohorts. Is clinical practice concordant with the changes in guidelines for antiretroviral therapy initiation during primary and chronic HIV-1 infection? The ANRS PRIMO and COPANA cohorts. PLoS One. 2013 Aug 1;8(8):e71473. doi: 10.1371/journal.pone.0071473. Print 2013. Erratum in: PLoS One. 2013;8(11). doi:10.1371/annotation/aed12a66-9c76-4e49-806b-881a2fe23bba. Goujard, Cecile [added].

ReferenceCitation: Legeai C, Vigouroux C, Souberbielle JC, Bouchaud O, Boufassa F, Bastard JP, Carlier R, Capeau J, Goujard C, Meyer L, Viard JP; ANRS-COPANA Cohort Study Group. Associations between 25-hydroxyvitamin D and immunologic, metabolic, inflammatory markers in treatment-naive HIV-infected persons: the ANRS CO9 "COPANA" cohort study. PLoS One. 2013 Sep 18;8(9):e74868. doi: 10.1371/journal.pone.0074868. eCollection 2013.

ReferenceCitation: Boufassa F, Lechenadec J, Meyer L, Costagliola D, Hunt PW, Pereyra F, Deeks S, Pancino G, Taulera O, Lichterfeld M, Delobel P, Saez-Cirion A, Lambotte O; ANRS CO18 HIV Controllers Cohort; Cascade Collaboration in Eurocoord; SCOPE Cohort; International HIV Controllers Study. Blunted response to combination antiretroviral therapy in HIV elite controllers: an international HIV controller collaboration. PLoS One. 2014 Jan 17;9(1):e85516. doi: 10.1371/journal.pone.0085516. eCollection 2014.

ReferenceCitation: El Khoury P, Ghislain M, Villard EF, Le Goff W, Lascoux-Combe C, Yeni P, Meyer L, Vigouroux C, Goujard C, Guerin M. Plasma cholesterol efflux capacity from human THP-1 macrophages is reduced in HIV-infected patients: impact of HAART. J Lipid Res. 2015 Mar;56(3):692-702. doi: 10.1194/jlr.M054510. Epub 2015 Jan 8.

ReferenceCitation: Ghislain M, Bastard JP, Meyer L, Capeau J, Fellahi S, Gérard L, May T, Simon A, Vigouroux C, Goujard C; ANRS-COPANA Cohort Study Group. Late Antiretroviral Therapy (ART) Initiation Is Associated with Long-Term Persistence of Systemic Inflammation and Metabolic Abnormalities. PLoS One. 2015 Dec 4;10(12):e0144317. doi: 10.1371/journal.pone.0144317. eCollection 2015.

ReferenceCitation: Ploquin MJ, Madec Y, Casrouge A, Huot N, Passaes C, Lécuroux C, Essat A, Boufassa F, Jacquelin B, Jochems SP, Petitjean G, Angin M, Gärtner K, Garcia-Tellez T, Noël N, Booiman T, Boeser-Nunnink BD, Roques P, Saez-Cirion A, Vaslin B, Dereudre-Bosquet N, Barré-Sinoussi F, Ghislain M, Rouzioux C, Lambotte O, Albert ML, Goujard C, Kootstra N, Meyer L, Müller-Trutwin MC. Elevated Basal Pre-infection CXCL10 in Plasma and in the Small Intestine after Infection Are Associated with More Rapid HIV/SIV Disease Onset. PLoS Pathog. 2016 Aug 10;12(8):e1005774. doi: 10.1371/journal.ppat.1005774. eCollection 2016 Aug.

ipd_sharing: No

lead_sponsor: ANRS, Emerging Infectious Diseases


title: A Randomized Double-blind Placebo-controlled Clinical Trial Assessing the Efficacy and Safety of Hépar® in Chronic Constipation

summary: The study objectives are to evaluate the efficacy and safety of a 2-week daily intake of 1L Hépar® natural mineral water rich in magnesium sulphate compared to a control natural mineral water in the treatment of the constipation symptoms in women outpatients.

lead_sponsor: Quanta Medical

lead_sponsor_type: industriel


title: Sleep, Autonomic Nervous System and Cardiorespiratory Capacity in Autism Spectrum Disorders Children

acronym: APAUTRES

summary:
Autism Spectrum Disorders (ASD) is a neurodevelopmental disorder which involves social and behavioural impairments. Autonomic dysfunctions and disturbed sleep were often associated to ASD. The investigators proposed to explore the impact of physical activity on these disorders. In this context, it is necessary to characterize the cardiorespiratory capacities of ASD children in order to promote physical activity for this population. To examine potential differences between ASD and control children, some explorations were proposed: a maximal treadmill test, motor evaluation, and orthostatic test (for the evaluation of autonomic nervous system).

An actimetry during one week (evaluation of physical activity and sleep) completed this study in order to specify sleep characteristic and established the possible link between physical activity sleep characteristics and physical fitness in ASD children.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Grenoble


title: Prospective Multi-centre Observational Study on the Epidemiology, Risk Factors and Consequences of Unexpected Cardiac Arrest in Intensive Care Units.

acronym: ACIR

summary: Unexpected cardiac arrest involves approximately 0.5 to 5% of patients admitted in Intensive Care Unit (ICU). Even if they have a technical environment conducive to prompt diagnosis and prompt treatment, patients hospitalized in ICU suffer from chronic illnesses and organ failure(s) that obscure the prognosis of cardiac arrest. Although extra cardiac arrhythmias or intra-hospital arrests are the subject of numerous publications, few studies specifically focus on unexpected cardiac arrest in ICU (none in France). The objective of our work is to produce a prospective epidemiological description of unexpected cardiac arrest in in French ICUs.

ReferenceCitation: Rozen TH, Mullane S, Kaufman M, Hsiao YF, Warrillow S, Bellomo R, Jones DA. Antecedents to cardiac arrests in a teaching hospital intensive care unit. Resuscitation. 2014 Mar;85(3):411-7. doi: 10.1016/j.resuscitation.2013.11.018. Epub 2013 Dec 8.

ReferenceCitation: Knaus WA, Zimmerman JE, Wagner DP, Draper EA, Lawrence DE. APACHE-acute physiology and chronic health evaluation: a physiologically based classification system. Crit Care Med. 1981 Aug;9(8):591-7.

ReferenceCitation: Synek VM. EEG abnormality grades and subdivisions of prognostic importance in traumatic and anoxic coma in adults. Clin Electroencephalogr. 1988 Jul;19(3):160-6.

ReferenceCitation: Myrianthefs P, Kalafati M, Lemonidou C, Minasidou E, Evagelopoulou P, Karatzas S, Baltopoulos G. Efficacy of CPR in a general, adult ICU. Resuscitation. 2003 Apr;57(1):43-8.

ReferenceCitation: Lesieur O, Leloup M, Gonzalez F, Mamzer MF; EPILAT Study Group. Eligibility for organ donation following end-of-life decisions: a study performed in 43 French intensive care units. Intensive Care Med. 2014 Sep;40(9):1323-31. doi: 10.1007/s00134-014-3409-2. Epub 2014 Aug 5.

ReferenceCitation: Lee HK, Lee H, No JM, Jeon YT, Hwang JW, Lim YJ, Park HP. Factors influencing outcome in patients with cardiac arrest in the ICU. Acta Anaesthesiol Scand. 2013 Jul;57(6):784-92. doi: 10.1111/aas.12117. Epub 2013 Mar 31.

ReferenceCitation: Peterson MW, Geist LJ, Schwartz DA, Konicek S, Moseley PL. Outcome after cardiopulmonary resuscitation in a medical intensive care unit. Chest. 1991 Jul;100(1):168-74.

ReferenceCitation: Enohumah KO, Moerer O, Kirmse C, Bahr J, Neumann P, Quintel M. Outcome of cardiopulmonary resuscitation in intensive care units in a university hospital. Resuscitation. 2006 Nov;71(2):161-70. Epub 2006 Sep 20.

ReferenceCitation: Landry FJ, Parker JM, Phillips YY. Outcome of cardiopulmonary resuscitation in the intensive care setting. Arch Intern Med. 1992 Nov;152(11):2305-8.

ReferenceCitation: Tian J, Kaufman DA, Zarich S, Chan PS, Ong P, Amoateng-Adjepong Y, Manthous CA; American Heart Association National Registry for Cardiopulmonary Resuscitation Investigators. Outcomes of critically ill patients who received cardiopulmonary resuscitation. Am J Respir Crit Care Med. 2010 Aug 15;182(4):501-6. doi: 10.1164/rccm.200910-1639OC. Epub 2010 Apr 22.

ReferenceCitation: Kutsogiannis DJ, Bagshaw SM, Laing B, Brindley PG. Predictors of survival after cardiac or respiratory arrest in critical care units. CMAJ. 2011 Oct 4;183(14):1589-95. doi: 10.1503/cmaj.100034. Epub 2011 Aug 15.

ReferenceCitation: Smith DL, Kim K, Cairns BA, Fakhry SM, Meyer AA. Prospective analysis of outcome after cardiopulmonary resuscitation in critically ill surgical patients. J Am Coll Surg. 1995 Apr;180(4):394-401.

ReferenceCitation: Cummins RO, Chamberlain D, Hazinski MF, Nadkarni V, Kloeck W, Kramer E, Becker L, Robertson C, Koster R, Zaritsky A, Bossaert L, Ornato JP, Callanan V, Allen M, Steen P, Connolly B, Sanders A, Idris A, Cobbe S. Recommended guidelines for reviewing, reporting, and conducting research on in-hospital resuscitation: the in-hospital 'Utstein style'. American Heart Association. Circulation. 1997 Apr 15;95(8):2213-39.

ReferenceCitation: Langhelle A, Nolan J, Herlitz J, Castren M, Wenzel V, Soreide E, Engdahl J, Steen PA; 2003 Utstein Consensus Symposium. Recommended guidelines for reviewing, reporting, and conducting research on post-resuscitation care: the Utstein style. Resuscitation. 2005 Sep;66(3):271-83.

ReferenceCitation: Gershengorn HB, Li G, Kramer A, Wunsch H. Survival and functional outcomes after cardiopulmonary resuscitation in the intensive care unit. J Crit Care. 2012 Aug;27(4):421.e9-17. doi: 10.1016/j.jcrc.2011.11.001. Epub 2012 Jan 9.

ReferenceCitation: Skrifvars MB, Varghese B, Parr MJ. Survival and outcome prediction using the Apache III and the out-of-hospital cardiac arrest (OHCA) score in patients treated in the intensive care unit (ICU) following out-of-hospital, in-hospital or ICU cardiac arrest. Resuscitation. 2012 Jun;83(6):728-33. doi: 10.1016/j.resuscitation.2011.11.036. Epub 2012 Jan 25. Erratum in: Resuscitation. 2013 Mar;84(3):395-6.

ReferenceCitation: Efendijev I, Raj R, Reinikainen M, Hoppu S, Skrifvars MB. Temporal trends in cardiac arrest incidence and outcome in Finnish intensive care units from 2003 to 2013. Intensive Care Med. 2014 Dec;40(12):1853-61. doi: 10.1007/s00134-014-3509-z. Epub 2014 Nov 12.

ReferenceCitation: Vincent JL, Moreno R, Takala J, Willatts S, De Mendonça A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10.

ReferenceCitation: Lesieur O, Leloup M, Gonzalez F, Mamzer MF; EPILAT study group. Withholding or withdrawal of treatment under French rules: a study performed in 43 intensive care units. Ann Intensive Care. 2015 Dec;5(1):56. doi: 10.1186/s13613-015-0056-x. Epub 2015 Jun 19.

ReferenceType: result

ReferenceCitation: Leloup M, Briatte I, Langlois A, Cariou A, Lesieur O; ACIR study group. Unexpected cardiac arrests occurring inside the ICU: outcomes of a French prospective multicenter study. Intensive Care Med. 2020 May;46(5):1005-1015. doi: 10.1007/s00134-020-05992-w. Epub 2020 Mar 9.

family: Leloup

full_name: Maxime Leloup

given: Maxime

family: Briatte

full_name: Isabelle Briatte

given: Isabelle

family: Langlois

full_name: Alice Langlois

given: Alice

family: Cariou

full_name: Alain Cariou

given: Alain

family: Lesieur

full_name: Olivier Lesieur

given: Olivier

journal_name: Intensive Care Medicine

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing: Undecided

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

location_facility:
CH Lens
CH Pontoise
CH Béthune
CH Blois
CH Agen
CHU Poitiers
CH Gueret
CH Melun
CH Versailles
CHU Nantes
CH Chartres
APHP Cochin
CH Dieppe
CH Cholet
CHU La Réunion
GH La Rochelle Ré Aunis
CHU Dijon
CH Sud Essonnes
CHU Brest
CH Arras
CHU Limoges
GH de l'Institut Catholique de Lille
CH Cahors
CHU Nîmes
Hôpital Paris Saint Joseph
GH Carnelle Portes de l'Oise
CH Bourg en Bresse
CH Colmar
APHP
CH Meaux
CHD Vendée
CH Roanne
CH Angouleme
CHU Angers
CH Pau
CHR Orleans
CH Cornouaille
APHP Saint Louis
CHU Caen
CHU Lyon
CHU Grenoble
CHU Rouen
CH Angoulême
CH Niort


title: Genetic Basis of Non Syndromic Congenital Diaphragmatic Hernia

acronym: HCD GENE

summary: In isolated congenital diaphragmatic hernia (CDH), recurrent risk is low suggesting the occurrence of novo mutations (dominant or recessive). Our objective is to test this hypothesis by combining the search for pathogenic genomic alteration and intragenic mutations through whole exome sequencing in a homogenous group of patients.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Genetic


title: Identification of Patients/Families With a Paediatric Tumor and One or More Developmental Abnormalities - Characterization of New Tumor Predisposition Syndromes and Study Their Molecular Basis

acronym: TED

summary: The overall project goal is to build a database of childhood cancers associated with developmental anomalies; it aims at identifying new syndromes of genetic predisposition and at enabling the further study of their molecular basis.

time_perspective: Other


title: Developing an Organization to Improve the Screening and Care of Starved Children in Hospital

acronym: PREDIRE

summary: This cluster-randomized trial will evaluate the impact of a multifaceted intervention (including electronic medical alerts) coordinated by a Nutritional Support Team, on adherence to recommended practices for care of starved children, among health personnel of a large university hospital. A key component of the study is to assess whether improved adherence to guidelines leads to a reduction in rates of complications.

primary_purpose: Prevention

ReferenceCitation: Duclos A, Touzet S, Restier L, Occelli P, Cour-Andlauer F, Denis A, Polazzi S, Colin C, Lachaux A, Peretti N; PREDIRE Study Group. Implementation of a computerized system in pediatric wards to improve nutritional care: a cluster randomized trial. Eur J Clin Nutr. 2015 Jul;69(7):769-75. doi: 10.1038/ejcn.2014.288. Epub 2015 Feb 4.

family: Duclos

full_name: A Duclos

given: A

family: Touzet

full_name: S Touzet

given: S

family: Restier

full_name: L Restier

given: L

family: Occelli

full_name: P Occelli

given: P

family: Cour-Andlauer

full_name: F Cour-Andlauer

given: F

family: Denis

full_name: A Denis

family: Polazzi

full_name: S Polazzi

family: Colin

full_name: C Colin

given: C

family: Lachaux

full_name: A Lachaux

family: Peretti

full_name: N Peretti

given: N

bso_classification: Biology (fond.)

journal_name: European Journal of Clinical Nutrition

ReferenceCitation: Touzet S, Duclos A, Denis A, Restier-Miron L, Occelli P, Polazzi S, Betito D, Gamba G, Cour-Andlauer F, Colin C, Lachaux A, Peretti N; PREDIRE Study Group. Multifaceted intervention to enhance the screening and care of hospitalised malnourished children: study protocol for the PREDIRE cluster randomized controlled trial. BMC Health Serv Res. 2013 Mar 22;13:107. doi: 10.1186/1472-6963-13-107.

full_name: Sandrine Touzet

given: Sandrine

full_name: Antoine Duclos

full_name: Angélique Denis

given: Angélique

family: Restier-Miron

full_name: Lioara Restier-Miron

given: Lioara

full_name: Pauline Occelli

given: Pauline

full_name: Stéphanie Polazzi

given: Stéphanie

family: Betito

full_name: Daniel Betito

given: Daniel

family: Gamba

full_name: Guillaume Gamba

given: Guillaume

full_name: Fleur Cour-Andlauer

given: Fleur

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

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

location_facility: Hospices Civils de Lyon (HCL) - Hôpital Femme-Mère-Enfant


title: Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate on Cutaneous Blood Flow in Healthy Volunteers

acronym: INFLUX-VS

summary: Iontophoresis is a employed to facilitate drug absorption without systemic effect. This study investigates cutaneous microcirculation when we associate sildenafil per os with SNP via iontophoresis.

ReferenceCitation: Cracowski JL, Minson CT, Salvat-Melis M, Halliwill JR. Methodological issues in the assessment of skin microvascular endothelial function in humans. Trends Pharmacol Sci. 2006 Sep;27(9):503-8. Epub 2006 Jul 31. Review.


title: Treatment of Greater Saphenous Vein (GSV) Insufficiency Using Echo-Guided Sclerotherapy With Lauromacrogol 400 Foam -Comparative Study of 3% Versus 1% Concentration.

summary: To evaluate the efficacy and the tolerance of echoguided sclerotherapy using Lauromacrogol 400 foam for the treatment of Great Saphenous Vein (GSV) insufficiency. A comparative study of 3% versus 1% Lauromacrogol 400 foam.

ReferenceCitation: Bosson JL, Riachi M, Pichot O, Michoud E, Carpentier PH, Franco A. Diameters of acute proximal and distal deep venous thrombosis of the lower limbs. Int Angiol. 1998 Dec;17(4):260-7.

ReferenceCitation: Ferretti GR, Bosson JL, Buffaz PD, Ayanian D, Pison C, Blanc F, Carpentier F, Carpentier P, Coulomb M. Acute pulmonary embolism: role of helical CT in 164 patients with intermediate probability at ventilation-perfusion scintigraphy and normal results at duplex US of the legs. Radiology. 1997 Nov;205(2):453-8.

ReferenceCitation: Barro C, Bosson JL, Pernod G, Carpentier PH, Polack B. Plasma D-dimer testing improves the management of thromboembolic disease in hospitalized patients. Thromb Res. 1999 Sep 1;95(5):263-9.

ReferenceCitation: Bosson JL, Labarere J, Sevestre MA, Belmin J, Beyssier L, Elias A, Franco A, Le Roux P. Deep vein thrombosis in elderly patients hospitalized in subacute care facilities: a multicenter cross-sectional study of risk factors, prophylaxis, and prevalence. Arch Intern Med. 2003 Nov 24;163(21):2613-8.

ReferenceCitation: Bosson JL, Labarère J, Barrellier MT, Belmin J, Couturier P, Le Roux P, Sevestre MA; Association pour la Promotion de l'Angiologie Hospitalière (APAH). [Practice guidelines for the prevention of venous thromboembolism in elderly patients hospitalized in subacute care and rehabilitation facilities (short text). Association for the Promotion of Hospital Angiology]. J Mal Vasc. 2003 Oct;28(4):209-18. French.

location_facility: Center of Vascular Medecine - 7 rue Lesdiguières


title: Double-blind Phase II Pilot Monocentric Randomized Clinical Trial Evaluating the Effect of a Preliminary Administration of Erythropoietin on Different Markers of Cardiac Ischemia Induced by Cardiopulmonary Bypass

acronym: EPOetCEC

summary: The main objective is to observe the effects of erythropoietin administration on different blood markers of ischaemic cardiac lesions induced by cardiopulmonary bypass.

ReferenceCitation: Bogoyevitch MA. An update on the cardiac effects of erythropoietin cardioprotection by erythropoietin and the lessons learnt from studies in neuroprotection. Cardiovasc Res. 2004 Aug 1;63(2):208-16. Review.

ReferenceCitation: Ehrenreich H, Hasselblatt M, Dembowski C, Cepek L, Lewczuk P, Stiefel M, Rustenbeck HH, Breiter N, Jacob S, Knerlich F, Bohn M, Poser W, Rüther E, Kochen M, Gefeller O, Gleiter C, Wessel TC, De Ryck M, Itri L, Prange H, Cerami A, Brines M, Sirén AL. Erythropoietin therapy for acute stroke is both safe and beneficial. Mol Med. 2002 Aug;8(8):495-505.

ReferenceCitation: Johnsson P, Bäckström M, Bergh C, Jönsson H, Lührs C, Alling C. Increased S100B in blood after cardiac surgery is a powerful predictor of late mortality. Ann Thorac Surg. 2003 Jan;75(1):162-8.

ReferenceCitation: Joyeux-Faure M, Godin-Ribuot D, Ribuot C. Erythropoietin and myocardial protection: what's new? Fundam Clin Pharmacol. 2005 Aug;19(4):439-46. Review.

ReferenceCitation: Kerbaul F, Giorgi R, Oddoze C, Collart F, Guidon C, Lejeune PJ, Villacorta J, Gouin F. High concentrations of N-BNP are related to non-infectious severe SIRS associated with cardiovascular dysfunction occurring after off-pump coronary artery surgery. Br J Anaesth. 2004 Nov;93(5):639-44. Epub 2004 Sep 3.

location_facility: Cardiac Surgery Department - CHU de Grenoble


title: Relevance of Valganciclovir in Recurrent Bouts of Cryptogenic Inflammatory Bowel Diseases With an Infection by Cytomegalovirus

summary: The main objective of this study is to demonstrate the relevance of Valganciclovir on recurrent bouts of cryptogenic inflammatory bowel diseases with infection by cytomegalovirus (CMV). The goal is to obtain 90% (for Valganciclovir treated patients) versus 50% (for placebo treated patients) remission at 3 months (including the discontinuation of corticoids or reducing their dose to under 20 mg of prednisone equivalence), without any relapse over the 6 following months.

ReferenceCitation: Orvar K, Murray J, Carmen G, Conklin J. Cytomegalovirus infection associated with onset of inflammatory bowel disease. Dig Dis Sci. 1993 Dec;38(12):2307-10.

ReferenceCitation: Hofkin GA, Ting CD. Case report: recurrence of chronic ulcerative colitis induced by intercurrent cytomegalic virus infection. Md Med J. 1995 Dec;44(12):1047-8.

ReferenceCitation: Rachima C, Maoz E, Apter S, Thaler M, Grossman E, Rosenthal T. Cytomegalovirus infection associated with ulcerative colitis in immunocompetent individuals. Postgrad Med J. 1998 Aug;74(874):486-9.

ReferenceCitation: Begos DG, Rappaport R, Jain D. Cytomegalovirus infection masquerading as an ulcerative colitis flare-up: case report and review of the literature. Yale J Biol Med. 1996 Jul-Aug;69(4):323-8. Review.

ReferenceCitation: Vega R, Bertrán X, Menacho M, Domènech E, Moreno de Vega V, Hombrados M, Cabré E, Ojanguren I, Gassull MA. Cytomegalovirus infection in patients with inflammatory bowel disease. Am J Gastroenterol. 1999 Apr;94(4):1053-6.

ReferenceCitation: Kaufman HS, Kahn AC, Iacobuzio-Donahue C, Talamini MA, Lillemoe KD, Hamilton SR. Cytomegaloviral enterocolitis: clinical associations and outcome. Dis Colon Rectum. 1999 Jan;42(1):24-30.

ReferenceCitation: Berk T, Gordon SJ, Choi HY, Cooper HS. Cytomegalovirus infection of the colon: a possible role in exacerbations of inflammatory bowel disease. Am J Gastroenterol. 1985 May;80(5):355-60.

ReferenceCitation: Pfau PR, Lichtenstein GR. Cytomegalovirus infection as a cause of ileoanal pouchitis. Dis Colon Rectum. 2000 Jan;43(1):113-4.

ReferenceCitation: Pfau P, Kochman ML, Furth EE, Lichtenstein GR. Cytomegalovirus colitis complicating ulcerative colitis in the steroid-naive patient. Am J Gastroenterol. 2001 Mar;96(3):895-9.

ReferenceCitation: Muñoz-Juarez M, Pemberton JH, Sandborn WJ, Tremaine WJ, Dozois RR. Misdiagnosis of specific cytomegalovirus infection of the ileoanal pouch as refractory idiopathic chronic pouchitis: report of two cases. Dis Colon Rectum. 1999 Jan;42(1):117-20.

ReferenceCitation: Moonka D, Furth EE, MacDermott RP, Lichtenstein GR. Pouchitis associated with primary cytomegalovirus infection. Am J Gastroenterol. 1998 Feb;93(2):264-6.

ReferenceCitation: Papadakis KA, Tung JK, Binder SW, Kam LY, Abreu MT, Targan SR, Vasiliauskas EA. Outcome of cytomegalovirus infections in patients with inflammatory bowel disease. Am J Gastroenterol. 2001 Jul;96(7):2137-42.

ReferenceCitation: Surawicz CM, Myerson D. Self-limited cytomegalovirus colitis in immunocompetent individuals. Gastroenterology. 1988 Jan;94(1):194-9.

location_facility: Gastroenterology Department - University Hospital of Grenoble

status_simplified: Unknown


title: Implication of Patient in the Making Ready of Recommendations for the Antivitamin K's Gestion in Case of Thrombosis Embolic Venous's Illness. Randomised Study for Clinical Validation.

summary: The objective of the project "Educ'Avk", is to document the efficacy of a strategy combining a specific follow up-notebook and education of attending patient with a pedagogic support, comparatively to an usual education on the impact of clinical events at three months (minor or major hemorrhagic events + recurrence of thrombi-embolic's disease).

ReferenceCitation: Gratacap-Cavallier B, Bosson JL, Morand P, Dutertre N, Chanzy B, Jouk PS, Vandekerckhove C, Cart-Lamy P, Seigneurin JM. Cytomegalovirus seroprevalence in French pregnant women: parity and place of birth as major predictive factors. Eur J Epidemiol. 1998 Feb;14(2):147-52.

ReferenceCitation: Bertrand D, François P, Bosson JL, Fauconnier J, Weil G. Quality assessment of discharge letters in a French university hospital. Int J Health Care Qual Assur Inc Leadersh Health Serv. 1998;11(2-3):90-5.

ReferenceCitation: Mezin P, Payen JF, Bosson JL, Brambilla E, Stieglitz P. Histological support for the difference between malignant hyperthermia susceptible (MHS), equivocal (MHE) and negative (MHN) muscle biopsies. Br J Anaesth. 1997 Sep;79(3):327-31.

ReferenceCitation: Payen JF, Bosson JL, Bourdon L, Jacquot C, Le Bas JF, Stieglitz P, Benabid AL. Improved noninvasive diagnostic testing for malignant hyperthermia susceptibility from a combination of metabolites determined in vivo with 31P-magnetic resonance spectroscopy. Anesthesiology. 1993 May;78(5):848-55.

ReferenceCitation: Vermont J, Bosson JL, François P, Robert C, Rueff A, Demongeot J. Strategies for graphical threshold determination. Comput Methods Programs Biomed. 1991 Jun;35(2):141-50.

location_facility: Cardiovascular Departement - University Hospital of Grenoble - BP 217

intervention_type: Behavioral


type: Other Identifier

title: Organization of Pulmonary Rehabilitation of Post-COVID-19 Patient With Sequelae. Assessment and Therapeutic Indication of Tele-rehabilitation Versus Conventional Rehabilitation

acronym: REHABCOVID

summary: Some patients with COVID-19 have sequelae after the acute phase of infection. These sequelae can be physical (dyspnea, exercise intolerance, abnormal fatigue) but also psychic (anxiety, depression). Systemic sequelae have also been observed in pulmonary, cardiac, hepatic, renal, nervous or immune systems. Respiratory rehabilitation (RR) is indicated in these patients to help their complete recovery without sequelae. These patients' arrival and sanitary constraints imposed by COVID-19 changed the organization of Health Care Centers (HCC). Risk of contagiousness after the acute phase of infection still exists. Consequently, patients must respect a quarantine time on their arrival in HCC and then have no contact with other HCC patients to respect the barrier rules and social distancing measures. HCC accommodation capacities are reduced and this is to the detriment of patients with chronic diseases for whom RR is essential. Certain HCCs saturation can also be responsible for a non-proposal of RR in the care pathway of patients after COVID-19. To cope with the new constraints imposed by Covid-19 pandemic, telemedicine is being developed in the affected industrial countries. Some SRH physicians are starting to offer post-COVID-19 patients the possibility of carrying out a tele-rehabilitation program (TRR). Such a telemedicine program has been validated for people with respiratory failure. It allows the patient to follow his care program without leaving his home and it does not require the visit from a health professional. In addition to reducing the inflow of post COVID-19 patients in HCC, it allows fragile patients to respect social distancing. It could also contain virus spread virus on the territory by reducing patient movements. When choosing between RR and TRR, the clinician must ask himself two questions. Is TRR as efficient as RR for post-COVID-19 patients? Is there a profile of patients for whom either method gives better results? This study proposes to evaluate both methods: a 4-week TRR program vs a conventional RR program in post COVID-19 patients with sequelae. If the hypothesis that both methods have similar effects is verified, this would allow the generalization of the prescription of TRR. The benefits will be individual with greater access to respiratory rehabilitation for post COVID-19 patients. There will also be collective public health benefits by maintaining sufficient access to HCC for patients with chronic diseases.

primary_purpose: Other

ReferenceCitation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.

ReferenceCitation: Crook S, Puhan MA, Frei A; STAND-UP and RIMTCORE study groups. The validation of the sit-to-stand test for COPD patients. Eur Respir J. 2017 Sep 20;50(3). pii: 1701506. doi: 10.1183/13993003.01506-2017. Print 2017 Sep.

ReferenceCitation: Vestbo J, Hurd SS, Agustí AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9. Review.

ReferenceCitation: Schwarz R, Krauss O, Hinz A. Fatigue in the general population. Onkologie. 2003 Apr;26(2):140-4.

ReferenceCitation: Roberge P, Doré I, Menear M, Chartrand E, Ciampi A, Duhoux A, Fournier L. A psychometric evaluation of the French Canadian version of the Hospital Anxiety and Depression Scale in a large primary care population. J Affect Disord. 2013 May;147(1-3):171-9. doi: 10.1016/j.jad.2012.10.029. Epub 2012 Dec 4.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility:
Hôpital Renée Sabran
Hôpital Nord (AP-HM)
HIA Sainte Anne


title: Immunological Repertoire in Patients With Lymphoma and Chronic Lymphocytic Leukemia, Biomedical Research on Medical Devices Human ImmunTracker and Human Immun'IgH

acronym: RIPAL

summary: RIPAL is a prospective cohort study, which main goal is to define T and B immune repertoire diversity and magnitude in patients with non-Hodgkin lymphoma of high and low grade and chronic lymphocytic leukemia before and after treatment, and to evaluate the association of these parameters with clinical patient data and outcomes.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud

intervention_type: Biological


title: Validation Study of the French Adaptation of the MSWDQ-23 Questionnaire, a Tool Assessing the Work Difficulties of Patients With Multiple Sclerosis.

acronym: WORKSEP

summary:
MS is an autoimmune disease of the central nervous system that affects more than 120,000 people in France. The average age of onset of the disease is between 25 and 35 years. Given the wide range of ages of the patients, from 4 to 80 years, the ethical and socio-economic stakes are high in order to maintain their autonomy, sociability, family and intimate life, and their employment in the best possible conditions and for as long as possible.

However, to date, there are no evaluation tools in French that allow us to understand the difficulties at work of MS patients.

The Multiple Sclerosis Work Difficulties Questionnaire (MSWDQ-23) was developed specifically for MS patients and validated in English [1]. There is a short version of this questionnaire that facilitates its use in clinical practice [2]. It has been translated and validated in Spanish through a multicenter study, and is currently being validated in German, but does not currently exist in French [3]. The main objective of the WORKSEP project is to validate the French version of this questionnaire through a multicenter population-based cohort within the framework of the French-speaking Multiple Sclerosis Society (SFSEP). This validation study will involve the inclusion of 206 French-speaking MS patients, regardless of their professional status, all forms of MS combined, from the early stage (Clinically Isolated Syndrome) to the more advanced stages (primary and secondary progressive forms).

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille


title: Pilot Study to Measure Exposure to Atazanavir, as a Component of Pharmacokinetic Parameters and Adherence Measured With MEMS in Naive HIV-infected Patients Treated Once Daily With Atazanavir Combined to Ritonavir and to Tenofovir/Emtricitabine. ANRS 134 Cophar 3

summary: the trial assessed the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.

ReferenceCitation: Parienti JJ, Barrail-Tran A, Duval X, Nembot G, Descamps D, Vigan M, Vrijens B, Panhard X, Taburet AM, Mentré F, Goujard C. Adherence profiles and therapeutic responses of treatment-naive HIV-infected patients starting boosted atazanavir-based therapy in the ANRS 134-COPHAR 3 trial. Antimicrob Agents Chemother. 2013 May;57(5):2265-71. doi: 10.1128/AAC.02605-12. Epub 2013 Mar 4.

name: Univ. Paris Diderot, Sorbonne Paris Cité, UMR 738, and INSERM, UMR 738, Paris, France

name: Department of Biostatistics and Clinical Research, Faculté de Médecine de Caen, Centre Hospitalier Universitaire de Caen Côte de Nacre, Caen, France

family: Parienti

full_name: Jean-Jacques Parienti

given: Jean-Jacques

name: Department of Clinical Pharmacy, Bicêtre Hospital, Assistance Publique Hôpitaux de Paris (AP-HP), Le Kremlin-Bicêtre, France

name: Department of Clinical Pharmacy, EA 4123, Faculté de Pharmacie, Univ. Paris-Sud 11, Chatenay Malabry, France

family: Barrail-Tran

full_name: Aurélie Barrail-Tran

given: Aurélie

family: Duval

full_name: Xavier Duval

given: Xavier

family: Nembot

full_name: Georges Nembot

given: Georges

name: Department of Virology, Bichat-Claude Bernard Hospital, Assistance Publique Hôpitaux de Paris (AP-HP), Paris, France

family: Descamps

full_name: Diane Descamps

given: Diane

family: Vigan

full_name: Marie Vigan

given: Marie

family: Vrijens

full_name: Bernard Vrijens

given: Bernard

family: Panhard

full_name: Xavière Panhard

given: Xavière

family: Taburet

full_name: Anne-Marie Taburet

given: Anne-Marie

family: Mentré

full_name: France Mentré

given: France

name: Department of Internal Medicine, Bicêtre Hospital, Assistance Publique Hôpitaux de Paris (AP-HP), Le Kremlin-Bicêtre, France

name: INSERM U1018, CESP, and Univ. Paris-Sud 11, Le Kremlin-Bicêtre, France

family: Goujard

full_name: Cécile Goujard

given: Cécile

journal_name: Antimicrobial Agents and Chemotherapy

oa_colors: green hybrid

oa_host_type: publisher;repository

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

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

repository_normalized: HAL

version: submittedVersion

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

repositories:
HAL
PubMed Central

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

title: Adherence Profiles and Therapeutic Responses of Treatment-Naive HIV-Infected Patients Starting Boosted Atazanavir-Based Therapy in the ANRS 134-COPHAR 3 Trial

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

location_facility: Hopital du Kremlin Bicêtre Service de médecine interne


title: An Open Label, Multicenter, Randomized Trial of 2% Chlorhexidine-70% Isopropanol vs 5% Povidone Iodine-69% Ethanol for Skin Antisepsis in Reducing Surgical-site Infection After Cardiac Surgery

summary:
Despite completion of more than 9 million procedures each year in France, the best antiseptic solution to be used for preparing the skin to reduce risk of surgical site infection (SSI) remains unknown. 2% Chlorhexidine gluconate (CHG)-alcohol is superior to Povidone Iodine (PVI)-alcohol for short term vascular catheter care (Mimoz O, Lancet 2015; Pages J, Intensive Care Med 2016), but studies comparing both antiseptic solutions for clean-contaminated surgical procedures led to conflicting results.

The present study will be the first large scale multicenter randomized controlled trial adequately powered to compare efficacy and safety of CHG-alcohol over PVI-alcohol in reducing SSI after clean surgery.

A clean surgery was chosen because pathogens involved in SSI mostly originate from skin. Therefore, optimisation of skin disinfection before surgery has the potential to reduce the incidence of SSI. Cardiac surgery was chosen because SSI may be severe, diagnosis of SSI is easy to monitor and to define and infections arise earlier than other frequent clean surgeries using implants such as orthopaedic or vascular surgery.

The incidence of reoperation for any purpose will be used as the main objective because there are easy to track and define and are less susceptible to interpretation in an open trial than superficial SSI. According to CDC criteria, patients will be monitored up to Day 90 because mediastinitis after cardiac surgery may occur after the usual 30-day SSI surveillance period.

ReferenceCitation: Boisson M, Corbi P, Kerforne T, Camilleri L, Debauchez M, Demondion P, Eljezi V, Flecher E, Lepelletier D, Leprince P, Nesseler N, Nizou JY, Roussel JC, Rozec B, Ruckly S, Lucet JC, Timsit JF, Mimoz O. Multicentre, open-label, randomised, controlled clinical trial comparing 2% chlorhexidine-70% isopropanol and 5% povidone iodine-69% ethanol for skin antisepsis in reducing surgical-site infection after cardiac surgery: the CLEAN 2 study protocol. BMJ Open. 2019 Jun 17;9(6):e026929. doi: 10.1136/bmjopen-2018-026929.

family: Boisson

full_name: Matthieu Boisson

given: Matthieu

family: Corbi

full_name: Pierre Corbi

given: Pierre

family: Kerforne

full_name: Thomas Kerforne

given: Thomas

family: Camilleri

full_name: Lionel Camilleri

given: Lionel

family: Debauchez

full_name: Mathieu Debauchez

given: Mathieu

family: Demondion

full_name: Pierre Demondion

family: Eljezi

full_name: Vedat Eljezi

given: Vedat

family: Flecher

full_name: Erwan Flecher

given: Erwan

family: Lepelletier

full_name: Didier Lepelletier

given: Didier

family: Leprince

full_name: Pascal Leprince

given: Pascal

family: Nesseler

full_name: Nicolas Nesseler

given: Nicolas

family: Nizou

full_name: Jacques Yves Nizou

given: Jacques Yves

family: Roussel

full_name: Jean Christian Roussel

given: Jean Christian

family: Rozec

full_name: Bertrand Rozec

given: Bertrand

family: Ruckly

full_name: Stéphane Ruckly

given: Stéphane

family: Lucet

full_name: Jean-Christophe Lucet

given: Jean-Christophe

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

family: Mimoz

full_name: Olivier Mimoz

given: Olivier

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

title: Multicentre, open-label, randomised, controlled clinical trial comparing 2% chlorhexidine–70% isopropanol and 5% povidone iodine–69% ethanol for skin antisepsis in reducing surgical-site infection after cardiac surgery: the CLEAN 2 study protocol

location_facility:
University Hospital of Bordeaux
La Pitié Salpétrière Hospital
CHRU de Strasbourg
University Hospital of Clermont-Ferrand
University Hospital of Poitiers
University Hospital of Rennes
University Hospital of Nantes
CHU de Toulouse
Institut Mutualiste Montsouris


summary: The objective of this trial is to show the therapeutic efficacy of the preventive pacing therapies of the Selection 9000 and Vitatron T70 DR pacemakers, dedicated to handle atrial fibrillation (AF). Two new algorithms (post-AF response and ventricular rate stabilization [VRS]) will be assessed in a combined pathway, compared to a control group. The efficacy of the overall available therapies to prevent AF and its symptoms will then be assessed also.

status: Unknown status

ReferenceCitation: Fauchier L, Briand F, Soto FX, Quennelle F, Lévy J, Darmon JP, Lellouche D, Lavergne T, Poret P, Pelade C, Babuty D. Management of atrial tachyarrhythmias: benefits of pacemaker diagnostics. Pacing Clin Electrophysiol. 2003 Jan;26(1P2):233-8.

ReferenceCitation: Camm AJ on behalf of the AFTherapy Study Group. The Atrial Fibrillation Therapy Study. Présentation orale au cours du Congrès de l'ESC à Stockholm, Septembre 2001.

ReferenceCitation: Fuster V, Rydén LE, Asinger RW, Cannom DS, Crijns HJ, Frye RL, Halperin JL, Kay GN, Klein WW, Lévy S, McNamara RL, Prystowsky EN, Wann LS, Wyse DG; American College of Cardiology; American Heart Association; European Society of Cardiology; North American Society of Pacing and Electrophysiology. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to develop guidelines for the management of patients with atrial fibrillation) developed in collaboration with the North American Society of Pacing and Electrophysiology. Eur Heart J. 2001 Oct;22(20):1852-923.

ReferenceCitation: Tse HF, Lau CP, Ayers GM. Incidence and modes of onset of early reinitiation of atrial fibrillation after successful internal cardioversion, and its prevention by intravenous sotalol. Heart. 1999 Sep;82(3):319-24.

ReferenceCitation: Falk RH. Management of atrial fibrillation--radical reform or modest modification? N Engl J Med. 2002 Dec 5;347(23):1883-4.

ReferenceCitation: Van Gelder IC, Hagens VE, Bosker HA, Kingma JH, Kamp O, Kingma T, Said SA, Darmanata JI, Timmermans AJ, Tijssen JG, Crijns HJ; Rate Control versus Electrical Cardioversion for Persistent Atrial Fibrillation Study Group. A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1834-40.

ReferenceCitation: Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD; Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1825-33.

ReferenceCitation: Hohnloser SH, Kuck KH, Lilienthal J. Rhythm or rate control in atrial fibrillation--Pharmacological Intervention in Atrial Fibrillation (PIAF): a randomised trial. Lancet. 2000 Nov 25;356(9244):1789-94.

ReferenceCitation: Hohnloser SH, Kuck KH. Randomized trial of rhythm or rate control in atrial fibrillation: the Pharmacological Intervention in Atrial Fibrillation Trial (PIAF). Eur Heart J. 2001 May;22(10):801-2.

ReferenceCitation: Haïssaguerre M, Jaïs P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Métayer P, Clémenty J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66.

ReferenceCitation: Defaye P, Dournaux F, Mouton E. Prevalence of supraventricular arrhythmias from the automated analysis of data stored in the DDD pacemakers of 617 patients: the AIDA study. The AIDA Multicenter Study Group. Automatic Interpretation for Diagnosis Assistance. Pacing Clin Electrophysiol. 1998 Jan;21(1 Pt 2):250-5.

ReferenceCitation: Andersen HR, Nielsen JC, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. Lancet. 1997 Oct 25;350(9086):1210-6.

ReferenceCitation: Connolly SJ, Kerr CR, Gent M, Roberts RS, Yusuf S, Gillis AM, Sami MH, Talajic M, Tang AS, Klein GJ, Lau C, Newman DM. Effects of physiologic pacing versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. Canadian Trial of Physiologic Pacing Investigators. N Engl J Med. 2000 May 11;342(19):1385-91.

ReferenceCitation: Gillis AM, Connolly SJ, Lacombe P, Philippon F, Dubuc M, Kerr CR, Yee R, Rose MS, Newman D, Kavanagh KM, Gardner MJ, Kus T, Wyse DG. Randomized crossover comparison of DDDR versus VDD pacing after atrioventricular junction ablation for prevention of atrial fibrillation. The atrial pacing peri-ablation for paroxysmal atrial fibrillation (PA (3)) study investigators. Circulation. 2000 Aug 15;102(7):736-41.

ReferenceCitation: Edvardson N. Efficacy of preventive pacing therapies in Paroxysmal Atrial Fibrillation - IV International meeting - Atrial Fibrillation 2001 : 161-164.

ReferenceCitation: Hoffmann E, Janko S, Steinbeck G and al. Onset scenarios of paroxysmal atrial fibrillation using new diagnostic pacemaker functions. Pacing Clin Electrophysiol. 2000 ; 23(4) : 656 (abstract).

ReferenceCitation: Hoffmann E, Janko S, Steinbeck G and al. Analysis of Onset Mechanisms of Paroxysmal Atrial Fibrillation through a Pacemaker with Continuous Monitoring Capabilities. Pacing Clin Electrophysiol. 2000 ; 23(4) : 656 (poster).

ReferenceCitation: Capucci A, Gropppi F, Ruiter J on behalf of the AFTherapy Study Group. Re-initiation of atrial Fibrillation Investigated Through pacemaker Focussed Diagnostics. Europace 2000 - Supplement 1.

ReferenceCitation: Tse HF, Lau CP, Ayers GM. Atrial pacing for suppression of early reinitiation of atrial fibrillation after successful internal cardioversion. Eur Heart J. 2000 Jul;21(14):1167-76.

ReferenceCitation: Lee JK, Yee R, Braney M, Stoop G, Begemann M, Dunne C, Klein GJ, Krahn AD, Van Hemel NM. Acute testing of the rate-smoothed pacing algorithm for ventricular rate stabilization. Pacing Clin Electrophysiol. 1999 Apr;22(4 Pt 1):554-61.

ReferenceCitation: Lau CP, Jiang ZY, Tang MO. Efficacy of ventricular rate stabilization by right ventricular pacing during atrial fibrillation. Pacing Clin Electrophysiol. 1998 Mar;21(3):542-8.

ReferenceCitation: Daoud EG, Weiss R, Bahu M, Knight BP, Bogun F, Goyal R, Harvey M, Strickberger SA, Man KC, Morady F. Effect of an irregular ventricular rhythm on cardiac output. Am J Cardiol. 1996 Dec 15;78(12):1433-6.

ReferenceCitation: Yee R, Meijer A and Winkler WB and al. Effect of Chronic Ventricular Rate Stabilization on Rate Irregularity in Patients with Permanent Atrial Fibrillation. Progress in Clinical Pacing - Rome 2002 : 52 (abstract)

ReferenceCitation: Pfaiffer L, Canby P, Navone A and al. Impact of Atrial Rhythm Diagnostics on Clinical Management. Europace Supplements 2002 ; 3 : A 152 (abstract).

ReferenceCitation: Gregoratos G, Abrams J, Epstein AE, Freedman RA, Hayes DL, Hlatky MA, Kerber RE, Naccarelli GV, Schoenfeld MH, Silka MJ, Winters SL. ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices--summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee to Update the 1998 Pacemaker Guidelines). J Am Coll Cardiol. 2002 Nov 6;40(9):1703-19.

ReferenceCitation: Jenkins LS, Bubien RS. Quality of life in patients with atrial fibrillation. Cardiol Clin. 1996 Nov;14(4):597-606. Review.

ReferenceCitation: Carlioz R, Perrier E, Thomas O and al. Accuracy of atrial Tachyarrhythmia Monitoring in the Selection Device : Correlation with an External Holter Recording. Europace Suppl 2001 ; 2 : B199.

ReferenceCitation: Jenkins LS. Quality of life in Patients with Atrial Fibrillation. Circulation 1995 ; 92 (I) : 490 (abstract).

ReferenceCitation: Bubien RS, Knotts-Dolson SM, Plumb VJ, Kay GN. Effect of radiofrequency catheter ablation on health-related quality of life and activities of daily living in patients with recurrent arrhythmias. Circulation. 1996 Oct 1;94(7):1585-91.

lead_sponsor: Vitatron France

location_facility:
Clinique de Bordeaux Cauderan
CH René Pleven
CH
HIA Percy
CHG
CH Saint Philibert
Clinique Bouchard
Clinique Ambroise Paré
Hopital Privé
CHU La Timone
CMC Parly II
CMCO
Polyclinique Saint Laurent
Clinique de la Casamance
Institut Arnalt Tzanck
Hopital Cardiologique du Haut Leveque
Hopital Privé Claude Galien
CHU
CH Toulon

intervention_type: Device


title: A Prospective Randomized Controlled Multicentre Trial Comparing Half-dose Photodynamic Therapy (PDT) With High-density Subthreshold Micropulse Laser Treatment in Patients With Chronic Central Serous Chorioretinopathy (CSC)

acronym: PLACE

summary:
Chronic central serous chorioretinopathy (CSC) is a relatively frequent eye disease that often occurs in patients in the professionally active age range. In this disease, there is pooling of fluid under the central retina (the macula). This specific form of macular degeneration can cause permanent vision loss, image distortion, loss of color and contrast vision due to this fluid under the retina. An early diagnosis and treatment may improve the visual outcome and quality of life. To date there is no international consensus on the optimal treatment of chronic CSC. Many retrospective studies suggest that treatment with photodynamic therapy (PDT) is effective in chronic CSC. Micropulse laser (ML) therapy may also be effective in this disease.

The proposed study is the first prospective randomized controlled trial in chronic CSC. In this study, participants with chronic CSC will be randomized into two treatment groups, PDT or ML treatment. The trial is a superiority study, because retrospective studies suggest that PDT treatment may be more effective than ML treatment. Therefore, PDT treatment is challenged against ML treatment.

The null hypothesis of the study is that PDT treatment is more effective than ML treatment in patients with active chronic CSC. The alternative hypothesis is that PDT treatment is not more effective than ML treatment in these patients.

Treatment success will not only be based on anatomical improvement, but also on functional endpoints, which are most important from a patient's perspective.

The study will take place in five large tertiary referral university hospitals in Europe that have extensive experience with conducting clinical trials (in Nijmegen, the Netherlands; Cologne, Germany; Leiden, the Netherlands; Oxford, United Kingdom; and Paris, France). Each of these centers has confirmed sufficient funding to conduct the research. The study will last max. 8 months per participant. Each participant will come for 5 (in the case of 1 treatment) or 7 visits (in the case of 2 treatments). Study evaluations will be mostly part of regular clinical care. The whole study will last for max. 24 months.

ReferenceCitation: van Rijssen TJ, Hahn LC, van Dijk EHC, Tsonaka R, Scholz P, Breukink MB, Blanco-Garavito R, Souied EH, Keunen JEE, MacLaren RE, Querques G, Fauser S, Downes SM, Hoyng CB, Boon CJF. RESPONSE OF CHOROIDAL ABNORMALITIES TO PHOTODYNAMIC THERAPY VERSUS MICROPULSE LASER IN CHRONIC CENTRAL SEROUS CHORIORETINOPATHY: Place Trial Report No. 4. Retina. 2021 Oct 1;41(10):2122-2131. doi: 10.1097/IAE.0000000000003157.

family: van Rijssen

full_name: Thomas J. van Rijssen

given: Thomas J.

family: Hahn

full_name: Leo C. Hahn

given: Leo C.

family: van Dijk

full_name: Elon H.C. van Dijk

given: Elon H.C.

family: Tsonaka

full_name: Roula Tsonaka

given: Roula

family: Scholz

full_name: Paula Scholz

given: Paula

family: Breukink

full_name: Myrte B. Breukink

given: Myrte B.

family: Blanco-Garavito

full_name: Rocio Blanco-Garavito

given: Rocio

family: Souied

full_name: Eric H. Souied

given: Eric H.

family: Keunen

full_name: Jan E.E. Keunen

given: Jan E.E.

family: MacLaren

full_name: Robert E. MacLaren

given: Robert E.

family: Querques

full_name: Giuseppe Querques

given: Giuseppe

family: Fauser

full_name: Sascha Fauser

given: Sascha

family: Downes

full_name: Susan M. Downes

given: Susan M.

family: Hoyng

full_name: Carel B. Hoyng

given: Carel B.

family: Boon

full_name: Camiel J.F. Boon

given: Camiel J.F.

journal_name: Retina

title: Response of choroidal abnormalities to photodynamic therapy versus micropulse laser in chronic central serous chorioretinopathy

ReferenceCitation: van Dijk EHC, Fauser S, Breukink MB, Blanco-Garavito R, Groenewoud JMM, Keunen JEE, Peters PJH, Dijkman G, Souied EH, MacLaren RE, Querques G, Downes SM, Hoyng CB, Boon CJF. Half-Dose Photodynamic Therapy versus High-Density Subthreshold Micropulse Laser Treatment in Patients with Chronic Central Serous Chorioretinopathy: The PLACE Trial. Ophthalmology. 2018 Oct;125(10):1547-1555. doi: 10.1016/j.ophtha.2018.04.021. Epub 2018 Jun 14.

family: Groenewoud

full_name: Joannes M.M. Groenewoud

given: Joannes M.M.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: Breukink MB, Mohr JK, Ossewaarde-van Norel A, den Hollander AI, Keunen JE, Hoyng CB, Boon CJ. Half-dose photodynamic therapy followed by diode micropulse laser therapy as treatment for chronic central serous chorioretinopathy: evaluation of a prospective treatment protocol. Acta Ophthalmol. 2016 Mar;94(2):187-97. doi: 10.1111/aos.12938. Epub 2015 Dec 15.

name: Department of Ophthalmology; Radboud University Medical Center; Nijmegen the Netherlands

name: Department of Ophthalmology; University Medical Center Utrecht; Utrecht the Netherlands

name: Department of Human Genetics; Radboud University Medical Center; Nijmegen the Netherlands

name: Department of Ophthalmology; Leiden University Medical Center; Leiden the Netherlands

ReferenceCitation: Breukink MB, Downes SM, Querques G, van Dijk EHC, den Hollander AI, Blanco-Garavito R, Keunen JEE, Souied EH, MacLaren RE, Hoyng CB, Fauser S, Boon CJF. Comparing half-dose photodynamic therapy with high-density subthreshold micropulse laser treatment in patients with chronic central serous chorioretinopathy (the PLACE trial): study protocol for a randomized controlled trial. Trials. 2015 Sep 21;16:419. doi: 10.1186/s13063-015-0939-z.

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

location_country:
Germany
United Kingdom
France
Netherlands

location_facility: Oxford University Eye Hospital, John Radcliffe Hospital

location_facility: Radboud University Nijmegen Medical Centre, Institute of Ophthalmology


title: Long-term Survival of Locally Advanced Breast Cancer Patients Treated With Neoadjuvant Chemotherapy With or Without Zoledronic Acid (ZOMETA®)

summary:
Breast cancer is the most common cancer in women and is the leading cause of death from cancer in France.

The main types of treatment used to treat breast cancer are surgery, chemotherapy, radiotherapy, hormone therapy and targeted therapies. In locally advanced breast cancer, a neo-adjuvant chemotherapy treatment is currently recommended as it may provide a sufficient tumour response to allow for conservative breast treatment.

Zoledronic acid (ZOL) is an N-biphosphonate used in the prevention of bone complications and in the treatment of hypercalcaemia In vitro and in vivo studies have shown an effect of ZOL on tumour and endothelial cells, supporting an anti-tumour activity of N-biphosphonates.

Between April 2010 and October 2013, 50 patients with locally advanced breast cancer were randomized in the NEOZOL study to receive neoadjuvant chemotherapy with (n=26) or without (n=24) zoledronic acid (ClinicalTrials.gov Identifier: NCT01367288). The primary objective of this study was to evaluate the effect of the addition of ZOMETA® to neoadjuvant chemotherapy on the change in serum VEGF concentration before and after neoadjuvant treatment (i.e. at the time of surgery).

Assessment of long-term survival was not planned in the NEOZOL study protocol. The objective of NEOZOL_FU study is to evaluate the survival of patients included in the NEOZOL study, 7 years after inclusion of the last patient.

This study will provide essential data on the long-term survival and risk of relapse of patients with locally advanced breast cancer who have received neo-adjuvant chemotherapy with or without zoledronic acid (ZOMETA®).

study_start_date_type: Anticipated

status: Not yet recruiting

time_perspective: Retrospective

location_facility: Centre Hospitalier Alpes Léman, Service de Gynécologie

location_facility: Centre Hospitalier Universitaire de Montpellier - Hôpital St Eloi

location_facility: Hôpital Femme Mère Enfant, Groupement Hospitalier EST, Service de Gynécologie Clinique

location_facility: Centre Léon Bérard, Département de Cancérologie Médicale

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth

location_facility: Centre de Lutte Contre le Cancer - Institut Jean Perrin, Service de Médecine Oncologique

location_facility: Centre Hospitalier de Thonon Hôpitaux du Léman, site Georges Pianta Service de Gynécologie Obstétrique

location_facility: Centre hospitalier de Bourg en Bresse, Hôpital Fleyriat, Service d'Onco-Hématologie et de Gynécologie Obstétrique

location_facility: Centre Hospitalier Universitaire de Limoges, Hôpital Dupuytren 1, Service d'Oncologie Médicale,

location_facility: Centre Hospitalier Universitaire de Poitiers, Hôpital la Milétrie


title: Vacuum Device for Hemostasis in Obstetrics and Gynecology. Feasibility Study for Postpartum Hemorrhage

summary:
Postpartum hemorrhage (PPH), is the leading cause of maternal mortality and is responsible for approximately 25% of maternal mortality deaths.It is defined as blood loss in excess of 500 ml following vaginal childbirth. Primary (immediate) PPH occurs within the first 24 hours after delivery.

In clinical practice, if after giving birth, the placenta is not expelled naturally, an active management should be triggered. After obstetric maneuvers therapeutic, options begin with uterotonic treatments before considering invasive treatments such as embolization, vessel ligation and hysterectomy. However, the morbidity associated with these techniques and the desire to preserve fertility mean that new therapeutic solutions have been conceived, which has recently led to the development of an innovative intrauterine hemostasis medical device : a hemostatic intrauterine suction cup.

Assuming that postpartum hemorrhages are mainly due to uterine atony, we propose in this biomedical research, the study of a new medical device. Our hypothesis is that the uterine walls will append to the walls of the suction cup after the latter is put under vacuum. The actuation of the suction cup will lead to the aspiration of all sides of the uterus.

Considering that postpartum haemorrhage is an emergency situation where vital prognosis of the patient is engaged, we selected to collect the consent of the patient using an emergengy procedure.


ReferenceCitation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

name: Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Kreuzberger

full_name: Nina Kreuzberger

given: Nina

family: Hirsch

full_name: Caroline Hirsch

given: Caroline

name: Transfusion Research Unit, School of Public Health and Preventive Medicine; Monash University; Melbourne Australia

family: Chai

full_name: Khai Li Chai

given: Khai Li

name: Population Health Sciences, Bristol Medical School; University of Bristol; Bristol UK

family: Tomlinson

full_name: Eve Tomlinson

given: Eve

family: Khosravi

full_name: Zahra Khosravi

given: Zahra

name: Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine; University Hospital Wuerzburg; Wuerzburg Germany

family: Popp

full_name: Maria Popp

given: Maria

family: Neidhardt

full_name: Miriam Neidhardt

given: Miriam

family: Piechotta

full_name: Vanessa Piechotta

given: Vanessa

name: Laboratory of Experimental Immunology, Institute of Virology; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Salomon

full_name: Susanne Salomon

given: Susanne

name: Jon J van Rood Center for Clinical Transfusion Research; Sanquin/Leiden University Medical Center; Leiden Netherlands

family: Valk

full_name: Sarah J Valk

given: Sarah J

family: Monsef

full_name: Ina Monsef

given: Ina

name: Department of Nephrology; Technical University of Munich, School of Medicine, Klinikum rechts der Isar; Munich Germany

family: Schmaderer

full_name: Christoph Schmaderer

given: Christoph

family: Wood

full_name: Erica M Wood

given: Erica M

name: Erasmus Medical Centre; Rotterdam Netherlands

family: So-Osman

full_name: Cynthia So-Osman

given: Cynthia

name: Systematic Review Initiative; NHS Blood and Transplant; Oxford UK

family: Roberts

full_name: David J Roberts

given: David J

family: McQuilten

full_name: Zoe McQuilten

given: Zoe

name: Haematology/Transfusion Medicine; NHS Blood and Transplant; Oxford UK

family: Estcourt

full_name: Lise J Estcourt

given: Lise J

name: Cochrane Cancer, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Skoetz

full_name: Nicole Skoetz

given: Nicole

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

location_facility:
Kremlin Bictre APHP
Cochin Aphp
Hegp Aphp

ipd_sharing: Yes

type: EudraCT Number

source: euctr

title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients

summary:
The overall objective of the study is to determine which treatments (e.g. immune modulator drugs) have the most favorable benefit-risk in adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation.

The specific aims of this Covid19 cohort are to collect observational data at regular intervals on an ongoing basis in order to embed a series of randomized controlled trials evaluating a various set of interventions for patients with COVID-19 pneumonia. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design.


title: Chronic Rhinosinusitis Classification Proposal: Evaluation of the Severity and the Effectiveness of Medical and Surgical Treatments

summary: Chronic rhinosinusitis (CRS) is a debilitating disease that remains (smell, nasal patency, flow) because currently treatment protocols available to us are with a limited efficacy. The assessment of the response to surgical treatment protocols and monitoring the become of patients treated with only drugs should allow investigators to identify the predictive patient's profile for the response. With this prospective data, this study would allow investigators to make a classification of Chronic rhinosinusitis.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac

summary:
Abdominal aortic aneurysms (AAAs) continue to be a leading cause of death in older age groups. In the 60-85 year-old population, AAA represents the 14th-leading cause of death. Federal funding through Medicare has been allocated for early detection using abdominal ultrasound screening programs. Despite these more aggressive screening programs and concerted efforts by surgeons for timely repair, the incidence of ruptured AAA has continued to increase.

Endovascular aneurysm repair (EVAR) has been the most common type of repair since 2006. Multiple studies reflecting decreased perioperative morbidity and mortality over open repair make this an attractive option for patients. EVAR requires more intensive follow-up than standard open surgical repair, however. Secondary interventions are more common to maintain "seal" of the endograft within the aorta and subsequent exclusion of the aneurysmal component.

The term endoleak is specific to EVAR, and describes the primary means by which endografts fail. Type I endoleaks occur because of inadequate graft seal proximally or distally, resulting in perigraft flow and aneurysm sac pressurization. Type II endoleaks occur when branch arteries arising from the aneurysmal aorta back-bleed into the aneurysm sac due to collateral flow. Type III endoleaks occur when flow persists between segments of a modular graft. Type IV endoleaks occur when flow persists through endograft material (graft porosity). Type V endoleaks have also been called "endotension", and occur when pressurization of the sac occurs in the absence of any demonstrable endoleak. Type I and Type III endoleaks are most concerning for rupture, although persistent Type II endoleaks can also lead to aneurysm rupture and premature death.

The most common method of EVAR follow-up is computed tomographic angiography (CTA). These studies allow accurate measurement of aneurysm sac diameters and volumes. They also are highly sensitive and specific for endoleaks. Type II endoleaks are treated if they remain persistent and are present in the setting of aneurysm sac enlargement. Type I and III endoleaks are immediately treated when identified. Type IV endoleaks are rarely seen with current endograft technology.

ReferenceCitation: Lederle FA, Freischlag JA, Kyriakides TC, Matsumura JS, Padberg FT Jr, Kohler TR, Kougias P, Jean-Claude JM, Cikrit DF, Swanson KM; OVER Veterans Affairs Cooperative Study Group. Long-term comparison of endovascular and open repair of abdominal aortic aneurysm. N Engl J Med. 2012 Nov 22;367(21):1988-97. doi: 10.1056/NEJMoa1207481.

family: Lederle

full_name: Frank A. Lederle

given: Frank A.

family: Freischlag

full_name: Julie A. Freischlag

given: Julie A.

family: Kyriakides

full_name: Tassos C. Kyriakides

given: Tassos C.

family: Matsumura

full_name: Jon S. Matsumura

given: Jon S.

family: Padberg

full_name: Frank T. Padberg

given: Frank T.

suffix: Jr.

family: Kohler

full_name: Ted R. Kohler

given: Ted R.

family: Kougias

full_name: Panagiotis Kougias

given: Panagiotis

family: Jean-Claude

full_name: Jessie M. Jean-Claude

given: Jessie M.

family: Cikrit

full_name: Dolores F. Cikrit

given: Dolores F.

family: Swanson

full_name: Kathleen M. Swanson

given: Kathleen M.

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Long-Term Comparison of Endovascular and Open Repair of Abdominal Aortic Aneurysm

ReferenceCitation: Jackson RS, Chang DC, Freischlag JA. Comparison of long-term survival after open vs endovascular repair of intact abdominal aortic aneurysm among Medicare beneficiaries. JAMA. 2012 Apr 18;307(15):1621-8. doi: 10.1001/jama.2012.453.

family: Chang

full_name: David C. Chang

given: David C.

journal_name: JAMA

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Comparison of Long-term Survival After Open vs Endovascular Repair of Intact Abdominal Aortic Aneurysm Among Medicare Beneficiaries

ReferenceCitation: Stather PW, Sidloff D, Dattani N, Choke E, Bown MJ, Sayers RD. Systematic review and meta-analysis of the early and late outcomes of open and endovascular repair of abdominal aortic aneurysm. Br J Surg. 2013 Jun;100(7):863-72. doi: 10.1002/bjs.9101. Epub 2013 Mar 8. Review.

name: Vascular Surgery Group, Department of Cardiovascular Sciences, University of Leicester, Leicester, UK

family: Stather

full_name: P W Stather

given: P W

family: Sidloff

full_name: D Sidloff

given: D

family: Dattani

full_name: N Dattani

given: N

family: Choke

full_name: E Choke

given: E

name: Leicester National Institute for Health Research Cardiovascular Biomedical Research Unit, Leicester, UK

family: Bown

full_name: M J Bown

given: M J

family: Sayers

ReferenceCitation: Piazza M, Frigatti P, Scrivere P, Bonvini S, Noventa F, Ricotta JJ 2nd, Grego F, Antonello M. Role of aneurysm sac embolization during endovascular aneurysm repair in the prevention of type II endoleak-related complications. J Vasc Surg. 2013 Apr;57(4):934-41. doi: 10.1016/j.jvs.2012.10.078. Epub 2013 Feb 4.

ReferenceCitation: Schanzer A, Greenberg RK, Hevelone N, Robinson WP, Eslami MH, Goldberg RJ, Messina L. Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair. Circulation. 2011 Jun 21;123(24):2848-55. doi: 10.1161/CIRCULATIONAHA.110.014902. Epub 2011 Apr 10. Erratum in: Circulation. 2012 Jan 17;125(2):e266.

name: From the University of Massachusetts Medical School, Worcester (A.S., W.P.R., M.H.E., R.J.G., L.M.); Cleveland Clinic Foundation, Cleveland, OH (R.K.G.); and Harvard School of Public Health, Boston, MA (N.H.).

title: Predictors of Abdominal Aortic Aneurysm Sac Enlargement After Endovascular Repair

ReferenceCitation: Fabre D, Mougin J, Mitilian D, Cochennec F, Garcia Alonso C, Becquemin JP, Desgranges P, Allaire E, Hamdi S, Brenot P, Bourkaib R, Haulon S. Prospective, Randomised Two Centre Trial of Endovascular Repair of Abdominal Aortic Aneurysm With or Without Sac Embolisation. Eur J Vasc Endovasc Surg. 2021 Feb;61(2):201-209. doi: 10.1016/j.ejvs.2020.11.028. Epub 2020 Dec 17.

journal_name: European Journal of Vascular and Endovascular Surgery

location_facility:
Hopital Henri Mondor - APHP
Centre Chirurgical MarieLannelongue
Institut Mutualiste Montsouris


title: What Are the Criteria for the Patient's Choice of Sel-catheterization Catheter

summary: The aim of this study is to evaluate which are the most important criteria guiding the choice of the catheter for the patient to perform clean intermittent self catheterization.

lead_sponsor: Gérard Amarenco

location_facility: department of Neuro-Urology, Hôpital Teno


title: Time to be Ready to Void: a New Tool to Assess the Time Needed to Perform Micturition for Patients With Multiple Sclerosis

summary: The aim of the study is to create a specific test to assess the global time required to go to the toilet and to perform micturition, at the moment the patient decides to urinate in multiple sclerosis population, and to assess its reliability.

location_facility: department of Neuro-Urology, Hôpital Tenon


title: Assessment of the Excitability of Spinal Motoneurons Using Stimulus-response Curves of the Bulbocavernosus Reflex

summary:
Spasticity is commonly observed in neurological conditions such as Multiple Sclerosis and spinal cord injury. "Peripheral" spasticity, concerning in particular the striated muscles of the limbs is nowadays well known and studied with clinical scales (Ashworth, Taridieu...) or even electrophysiological methods (H-reflex, T-reflex...). However, this spasticity can also affect the perineal muscles and more generally the pelvic muscles. However, there is to date no validated and standardized method for evaluating this pelvi-perineal spasticity.

The aim of the study will be to assess the spinal motoneurons excitability by using the stimulus-response curves of the bulbocavernosus reflex.

lead_sponsor: Pierre and Marie Curie University

location_facility: Department of neuro-urology, hôpital Tenon


title: How to Dress up in Neuro-urology Department

summary: This study assess patient preferences and perceptions regarding physician dress code in a neuro-urology department.

time_perspective: Cross-Sectional

location_facility: department of Neuro-Urology, Hôpital tenon


title: Prospective Clinical Trial to Assess Safety and Efficacy of DRV/r(TMC 114/r), ETV(TMC 125) and MK-0518 in Addition to OBT in HIV-1 Infected Patients With Limited to No Treatment Options ANRS 139 TRIO

acronym: ANRS139 TRIO

summary: The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant viruses and limited treatment options. An optimized background regimen that may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added, if possible, to this combination. Patients will undergo treatment for 48 weeks and virological efficacy will be evaluated at week 24.

location_facility: Hôpital Gustave Dron, Service Maladies Infectieuses


title: The French DIVAT: a Clinical Database Associated With a Biological Banking Accessible to Initiate Epidemiological and Translational Collaborative Researches in Kidney Transplantation

acronym: DIVAT

summary: The French DIVAT (standing for Données Informatisées et VAlidées en Transplantation in french, and in English "Computerized and VAlidated Data in Transplantation" ) cohort was Kicked off in 1994 by the Transplantation Urology Nephrology Institute of the Nantes University Hospital in France. The primary objective of this multicenter computerized database was to enable prospective clinical and epidemiological research studies concerning kidney transplant recipients, particularly focusing on mid- and long-term clinical outcomes, therapeutic strategies and public health issues. The patient-case system of the DIVAT cohort allows the monitoring of medical records of all patient-specific and allograft-specific data, including bio-banking since 2005. Data are collected from the date of transplantation until the graft failure, at each scheduled outpatient visit or hospital admission motivating by a new clinical, therapeutical or biological expression. The DIVAT cohort contains information on more than 11000 transplant recipients between 1994 and today, issued from 8 French university hospitals centers (the DIVAT Network is organized by a consortium agreement). 18% of all patients underwent retransplantation and 11% of all kidney transplants originated from living donors. The DIVAT network heavily works to ensure a high-quality data collection with the aim of exploring adequately the complex post-transplantation process. The Divat network encourage collaborations and enables interested researchers to submit a research project by completing a request form available on the DIVAT website (http://www.divat.fr/en) describing the context, objectives and design of the study

lead_sponsor: Nantes University Hospital

location_facility:
Pr Cassuto
Professeur Mourad
Professeur Ladriere
Professeur Legendre
Docteur Buron
Professeur Kreis
Professeur Rostaing
Professeur Kessler


title: Art'Health: Effects of Artistic and Participative Workshops at the MAMAC of Nice on the Health of Seniors

acronym: Art'Health

summary: Study with two arms, one of which receives an intervention in the form of participative artistic workshops at the MAMAC and the other was assigned as the control group. Well-being, Quality of life, Health, Apathy and Olfactory identification scales are proposed before the intervention, during the intervention at the end of each month (M1, M2, M3), 6 months after the end of the intervention (M9) and 12 months after the end of the intervention (M15).

location_facility: Centre Mémoire de Ressources et de Recherche, CHU de Nice


title: Quality of Life and Functional Prognosis at One Year of Patients With COVID-19 Admitted in Post-ICU Setting

acronym: COVENTRY

summary:
The COVID-19 disease has been subject to numerous publications since its emergence. Almost 20% of people suffering from COVID-19 develop severe to critical symptoms and require hospitalization, often in Intensive Care Unit (ICU). Respiratory failure is the main reason for admission in ICU of these patients. Therapeutic strategies implemented for the management of critically-ill patients may often lead to short-term muscular and functional alterations resulting in ICU-Acquired Weakness (ICUAW). These lead to long-term disabilities expressing trough dependence and quality of life impairment of survivors.

The purpose of this study is to assess the quality of life, dependence and survival at one year in patients who survived from COVID-19 in ICU and are admitted in post-ICU setting for difficult weaning purpose.

Ancillary studies aim to assess the course of muscle function (atrophy, structural modifications), lung function (loss of aeration) and safety of early mobilization.

status: Active, not recruiting

ReferenceCitation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648.

name: Chinese Center for Disease Control and Prevention, Beijing, China

family: Wu

full_name: Zunyou Wu

given: Zunyou

family: McGoogan

full_name: Jennifer M. McGoogan

given: Jennifer M.

ReferenceCitation: Murthy S, Gomersall CD, Fowler RA. Care for Critically Ill Patients With COVID-19. JAMA. 2020 Apr 21;323(15):1499-1500. doi: 10.1001/jama.2020.3633.

ReferenceCitation: Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. Review.

ReferenceCitation: Herridge MS, Moss M, Hough CL, Hopkins RO, Rice TW, Bienvenu OJ, Azoulay E. Recovery and outcomes after the acute respiratory distress syndrome (ARDS) in patients and their family caregivers. Intensive Care Med. 2016 May;42(5):725-738. doi: 10.1007/s00134-016-4321-8. Epub 2016 Mar 30. Review.

ReferenceCitation: Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, Girard M, Lu Q, Rouby JJ. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. doi: 10.1097/CCM.0b013e3181b08cdb.

ReferenceCitation: Peng QY, Wang XT, Zhang LN; Chinese Critical Care Ultrasound Study Group (CCUSG). Findings of lung ultrasonography of novel corona virus pneumonia during the 2019-2020 epidemic. Intensive Care Med. 2020 May;46(5):849-850. doi: 10.1007/s00134-020-05996-6. Epub 2020 Mar 12.

ReferenceCitation: Parry SM, El-Ansary D, Cartwright MS, Sarwal A, Berney S, Koopman R, Annoni R, Puthucheary Z, Gordon IR, Morris PE, Denehy L. Ultrasonography in the intensive care setting can be used to detect changes in the quality and quantity of muscle and is related to muscle strength and function. J Crit Care. 2015 Oct;30(5):1151.e9-14. doi: 10.1016/j.jcrc.2015.05.024. Epub 2015 Jun 3.

ReferenceCitation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

ReferenceCitation: KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9.

ReferenceCitation: Flaatten H, Kvåle R. Survival and quality of life 12 years after ICU. A comparison with the general Norwegian population. Intensive Care Med. 2001 Jun;27(6):1005-11.

ReferenceCitation: Cartwright MS, Kwayisi G, Griffin LP, Sarwal A, Walker FO, Harris JM, Berry MJ, Chahal PS, Morris PE. Quantitative neuromuscular ultrasound in the intensive care unit. Muscle Nerve. 2013 Feb;47(2):255-9. doi: 10.1002/mus.23525. Epub 2012 Oct 5.

ipd_sharing_description: The data that support the findings of this study will be openly available in "figshare".

location_facility: APHP - Hôpital Universitaire Pitié-Salpétrière

intervention_type: Diagnostic Test


title: Study of the Efficacy and Tolerance of Oral Treatment of Lcr Restituo® Sachets (Lactobacillus Rhamnosus Lcr35®) on Intolerance to Metformin (Diarrhoea) in Patients With Diabetes Type 2

acronym: PROVAME

summary:
The mechanisms of diarrhoea under metformin are poorly known. Recent data indicate that a change in gut flora might be responsible for this intestinal disorder. The effect of metformin on the gut flora has been extensively described. It has been shown that the therapeutic effect of metformin depends on the microbiota. In agreement with these data, a recent publication has shown that metformin's main site of action in humans was the intestine. In light of these results, it now seems plausible that metformin's effect on the gut flora is responsible not only for its therapeutic effect but also for its undesirable digestive effects. In this respect, Lactobacillus rhamnosus has shown anti-diarrhoeal effects (approximately 50% reduction in diarrhoeas) in the contexts of infection-caused dysbiosis and post-antibiotic dysbiosis.

Hypothesis: Taking into account the favourable effect on intestinal dysbiosis-induced diarrhoeas observed with Lactobacillus rhamnosus, we put forward the hypothesis that Lactobacillus rhamnosus Lcr35® will have a favourable effect on metformin-induced diarrhoea.

lead_sponsor: Biose


title: Multicentric Randomized Phase III Study of Post-Surgical NSCLC Follow-up

summary: The follow-up of patients operated on for lung cancer is heterogeneous. An intensive follow-up including routine clinic visits, chest X-rays, chest computed tomography (CT) scans and fiberoptic bronchoscopies might detect more small, potentially curable, recurrences and second cancers. However, as it appears in the American Society of Clinical Oncology (ASCO) recommendations, a large randomized study is necessary to evaluate the survival impact of such a follow-up strategy. This is the main objective of this IFCT-0302 study, which is a large randomized controlled study conducted in France comparing this intensive follow-up to a follow-up with only routine clinic visits and chest X-rays.

ReferenceCitation: Westeel V, Lebitasy MP, Mercier M, Girard P, Barlesi F, Blanchon F, Tredaniel J, Bonnette P, Woronoff-Lemsi MC, Breton JL, Azarian R, Falcoz PE, Friard S, Geriniere L, Laporte S, Lemarie E, Quoix E, Zalcman G, Guigay J, Morin F, Milleron B, Depierre A; Intergroupe Francophone de Cancerologie Thoracique (IFCT). [IFCT-0302 trial: randomised study comparing two follow-up schedules in completely resected non-small cell lung cancer]. Rev Mal Respir. 2007 May;24(5):645-52. French.

location_facility:
Centre Hospitalier - Pneumologie
Centre F. Baclesse
CHU - Pneumologie
CHU Besancon - Pneumologie
CHU Lyautey - Pneumologie
CHU Grenoble - pneumologie
Institut de Cancérologie de la Loire

intervention_type: Procedure


title: Breastfeeding Peer Counselling for Mothers of Preterm Neonates: a Stepped- Wedge Cluster Randomized Controlled Trial

acronym: ALAIS

summary:
Breastfeeding has a fundamental impact on the short-, medium- and long-term health of children and has an important impact on women's health. Breastfeeding protects against gastrointestinal and respiratory illnesses and is associated with better cognitive development in childhood, particularly in preterm infants. Despite these potential benefits, preterm infants experience lower rates of breastfeeding initiation and continuation compared to term infants.

The use of breastfeeding peer support initiatives, in which advice is given by experienced and trained peer counselors, is an effective way to promote and support breastfeeding, regardless of a woman's socioeconomic status. Several small studies have shown that breastfeeding peer support initiatives were effective for preterm infants and that this efficacy was increased by the co-intervention of lactation consultants.

The purpose of this study is to develop and to evaluate the effectiveness of a breastfeeding support program among mother-preterm infant dyads in Europe, by evaluating the impact of the intervention on 1) breastfeeding rates, 2) morbidity and mortality during the hospitalization, 3) children's cognitive development and behavior 4) mothers' mental health, 4) costs benefits.

The breastfeeding support program will include peer counselors under the supervision of lactation consultants. Breastfeeding counselors will be voluntary mothers who have had a positive breastfeeding experience with at least one preterm infant. After a training course, they will meet the future or new mothers by face-to-face and share their experiences at least once a week during hospitalization and provide phone support up to 1 month after discharge from hospital.

The study design will be a stepped wedge cluster trial conducted in 8 NICU in Europe (France, Switzerland and Belgium). Infants and mothers will be followed up from the time of hospitalization in the maternity and NICU up to 6 months after the discharge. The cost analysis will be performed in a subgroup of mother-preterm infant dyads that will be followed up at 24-months after their discharge

primary_purpose: Supportive Care

ReferenceCitation: Laborie S, Denis A, Horsch A, Occelli P, Margier J, Morisod Harari M, Claris O, Touzet S, Fischer Fumeaux CJ. Breastfeeding peer counselling for mothers of preterm neonates: protocol of a stepped-wedge cluster randomised controlled trial. BMJ Open. 2020 Jan 30;10(1):e032910. doi: 10.1136/bmjopen-2019-032910.

apc_source: openAPC

family: Laborie

full_name: Sophie Laborie

given: Sophie

family: Denis

full_name: Angelique Denis

given: Angelique

family: Horsch

full_name: Antje Horsch

given: Antje

family: Occelli

full_name: Pauline Occelli

given: Pauline

family: Margier

full_name: Jennifer Margier

given: Jennifer

family: Morisod Harari

full_name: Mathilde Morisod Harari

given: Mathilde

family: Claris

full_name: Olivier Claris

given: Olivier

family: Touzet

full_name: Sandrine Touzet

given: Sandrine

family: Fischer Fumeaux

full_name: Celine Julie Fischer Fumeaux

given: Celine Julie

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_country: Belgium France Switzerland

location_facility:
Hôpital des Enfants
CHU site Félix Guyon
CHC Clinique St-Vincent
CHU de Grenoble
CHU vaudois
CH Lyon Sud
Hôpital Femme Mère Enfant
Hôpital Nord Ouest - Villefranche


title: Prognosis of Anxiety in Intensive Care Unit

acronym: PAN-ICU

summary: Anxiety is commonly considered as an epiphenomenon of the cognitive and emotional response to a threat. Anxiety is a consequence of the reciprocal interaction between stress and the neuroendocrine, autonomic and immune systems. A systematic and circumstantial assessment of anxiety in critically ill patients has never been done. Our hypothesis is that high levels of anxiety at ICU admission are associated with death or the occurrence of one or more organ failure during the first 7 days, and that anxiety should be considered as a "warning sign" in critically ill patients.

ReferenceCitation: Mazeraud A, Polito A, Sivanandamoorthy S, Porcher R, Heming N, Stoclin A, Hissem T, Antona M, Blot F, Gaillard R, Chrétien F, Annane D, Bozza FAB, Siami S, Sharshar T; Groupe d'Explorations Neurologiques en Réanimation (GENER). Association Between Anxiety and New Organ Failure, Independently of Critical Illness Severity and Respiratory Status: A Prospective Multicentric Cohort Study. Crit Care Med. 2020 Oct;48(10):1471-1479. doi: 10.1097/CCM.0000000000004495.

family: Mazeraud

full_name: Aurélien Mazeraud

given: Aurélien

family: Polito

full_name: Andrea Polito

given: Andrea

family: Sivanandamoorthy

full_name: Sivanthiny Sivanandamoorthy

given: Sivanthiny

family: Porcher

full_name: Raphaël Porcher

given: Raphaël

family: Heming

full_name: Nicholas Heming

given: Nicholas

family: Stoclin

full_name: Annabelle Stoclin

given: Annabelle

family: Hissem

full_name: Tarik Hissem

given: Tarik

family: Antona

full_name: Marion Antona

given: Marion

family: Blot

full_name: François Blot

given: François

family: Gaillard

full_name: Raphaël Gaillard

family: Chrétien

full_name: Fabrice Chrétien

given: Fabrice

family: Annane

full_name: Djillali Annane

given: Djillali

family: Bozza

full_name: Fernando A. B. Bozza

given: Fernando A. B.

family: Siami

full_name: Shidasp Siami

given: Shidasp

family: Sharshar

full_name: Tarek Sharshar

given: Tarek

name: the Groupe d’Explorations Neurologiques en Réanimation (GENER)

journal_name: Critical Care Medicine

location_facility: General intensive care unit Raymond Poincaré Hospital