title: InterMob: a Randomized Controlled Trial Aimed at Reducing Car Use in Regular Car Users by Combining Hard and Soft Levers

acronym: InterMob

summary:
Regular car use is a source of pollution and physical inactivity. InterMob is an interdisciplinary randomized controlled behavioral intervention aiming at reducing car use. The objectives of InterMob are to a) Evaluate the efficacy of a theory- and evidence-based intervention, b) Identify the mechanisms related mobility change, and c) Identify the conditions under which the intervention is effective.

To meet these objectives, 300 regular car users living in Grenoble will be recruited and randomized in one of two arms:

experimental group that will receive the InterMob intervention: six months of free public transport/access to a bicycle, and behavior change techniques (personalized transport advice, setting of mobility change goals, considering possible obstacles; 6 months of motivational messages to prompt goal setting and self-monitoring).
active control group that will receive information about air pollution (discussion about the health consequences of air pollution, the association between air pollution and car use; 6 months of messages to prompt air pollution monitoring.) Follow-up measures will be carried out until 24 months after the beginning of the study (8-day measurement sessions). Five sessions will involve wearing a GPS/accelerometer, and an air pollution sensor. Participants will complete mobility logs and questionnaires measuring the psychological mechanisms related to their mobility (habits, intentions, self-efficacy), and socio-economical characteristics (number of children, accessibility) during the 8 sessions.

The investigators hypothesize that the participants allocated to experimental group will reduce the car use and increase the use of alternative modes to the car (biking, walking, public transport, and carpooling) more than the participants of the control group, and that these changes will remain. The investigators hypothesize that mobility changes will be mediated by intention and self-efficacy. The investigators hypothesize that the efficacy of the intervention will be moderated by socio-spatial factors (number of children, travel distances) and psychological factors (self-control).

The main criterion will be car use reduction and the use of alternative modes to the car. In addition, the investigators will assess physical activity (minutes of moderate-to-vigorous physical activity), the exposure to air pollution, the quality of life and the carbon footprint associated to transport.

status: Enrolling by invitation

ipd_sharing: Yes

ipd_sharing_description: Data dictionary, statistical analysis plan, informed consent form, analytic code will be shared.

lead_sponsor: Aina Chalabaev


title: Observatoire Des Patients Atteints de Laminopathies et Emerinopathies (Observatory for PAtients With Laminopathies and Emerinopathies)

acronym: OPALE

summary:
Laminopathies and emerinopathies are complex group of rare disorders due to mutations in A-type lamins (LMNA) and Emerin (EMD) genes. Among them, disorders affecting skeletal and/or cardiac muscles are the most frequent clinical manifestations, with cardiac disease being a major cause of death. Remarkable progress has been made in the description of the clinical and genetic spectrum of these diseases since the 1990's. Until now, precise phenotype/genotype relations remain elusive. As for several other neuromuscular disorders, apart from symptomatic treatments, there is currently no specific treatment to prevent or slow down the progression of the disease. The OPALE registry is a multicentre web-based registry dedicated to laminopathy and emerinopathy French patients. OPALE has been approved by ethical and regulatory authorities. Its main inclusion criteria is the presence of a proven pathogenic LMNA and/or EMD gene mutation.

The OPALE objectives are to provide a tool allowing detailed capture of patient genetic, neurological, cardiological, endocrinological and respiratory assessments, in order to allow i) precise disease natural history, ii) evaluation of different disease complication frequency and iii) identification of prognosis factors.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Wahbi K, Ben Yaou R, Gandjbakhch E, Anselme F, Gossios T, Lakdawala NK, Stalens C, Sacher F, Babuty D, Trochu JN, Moubarak G, Savvatis K, Porcher R, Laforêt P, Fayssoil A, Marijon E, Stojkovic T, Béhin A, Leonard-Louis S, Sole G, Labombarda F, Richard P, Metay C, Quijano-Roy S, Dabaj I, Klug D, Vantyghem MC, Chevalier P, Ambrosi P, Salort E, Sadoul N, Waintraub X, Chikhaoui K, Mabo P, Combes N, Maury P, Sellal JM, Tedrow UB, Kalman JM, Vohra J, Androulakis AFA, Zeppenfeld K, Thompson T, Barnerias C, Bécane HM, Bieth E, Boccara F, Bonnet D, Bouhour F, Boulé S, Brehin AC, Chapon F, Cintas P, Cuisset JM, Davy JM, De Sandre-Giovannoli A, Demurger F, Desguerre I, Dieterich K, Durigneux J, Echaniz-Laguna A, Eschalier R, Ferreiro A, Ferrer X, Francannet C, Fradin M, Gaborit B, Gay A, Hagège A, Isapof A, Jeru I, Juntas Morales R, Lagrue E, Lamblin N, Lascols O, Laugel V, Lazarus A, Leturcq F, Levy N, Magot A, Manel V, Martins R, Mayer M, Mercier S, Meune C, Michaud M, Minot-Myhié MC, Muchir A, Nadaj-Pakleza A, Péréon Y, Petiot P, Petit F, Praline J, Rollin A, Sabouraud P, Sarret C, Schaeffer S, Taithe F, Tard C, Tiffreau V, Toutain A, Vatier C, Walther-Louvier U, Eymard B, Charron P, Vigouroux C, Bonne G, Kumar S, Elliott P, Duboc D. Development and Validation of a New Risk Prediction Score for Life-Threatening Ventricular Tachyarrhythmias in Laminopathies. Circulation. 2019 Jul 23;140(4):293-302. doi: 10.1161/CIRCULATIONAHA.118.039410. Epub 2019 Jun 3.

name: APHP, Cochin Hospital, Cardiology Department, FILNEMUS, Centre de Référence de Pathologie Neuromusculaire Nord/Est/Ile de France, Paris-Descartes, Sorbonne Paris Cité University (K.W., D.D.).

name: INSERM Unit 970, Paris Cardiovascular Research Centre (PARCC), France (K.W., C. Stalens, E.J.).

family: Wahbi

full_name: Karim Wahbi

given: Karim

sequence: first

name: APHP, Centre de référence de pathologie neuromusculaire Paris-Est, FILNEMUS, Myology Institute, Neurology Department (R.B.Y., A.F., T.S., A.B., S.L.-L., K.C., H.-M.B., B.E.)

name: Sorbonne Universités, INSERM UMRS 974, CNRS, UMR-7215, Center for Research in Myology, Myology Institute,(R.B.Y., G.B.)

family: Ben Yaou

full_name: Rabah Ben Yaou

given: Rabah

sequence: additional

name: APHP, Institute of Cardiology (E.G., X.W., P.C.)

name: Sorbonne Universités, UPMC Univ Paris 06, INSERM 1166, Institute of Cardiometabolism and Nutrition (ICAN), France (E.G., P.C.).

name: Centre de Référence des Maladies Cardiaques Héréditaires, Paris, France† (E.G., P.C.).

family: Gandjbakhch

full_name: Estelle Gandjbakhch

given: Estelle

name: Cardiology Department, University Hospital of Rouen, France (F.A.).

family: Anselme

full_name: Frédéric Anselme

given: Frédéric

name: Inherited Cardiovascular Diseases Unit, University College London & St. Bartholomew’s Hospital, United Kingdom† (T.G., K.S., P.E.).

family: Gossios

full_name: Thomas Gossios

given: Thomas

name: Cardiovascular Division, Department of Medicine, Brigham and Women’s Hospital, Boston, MA (N.K.L., U.B.T.).

name: Aix Marseille University, INSERM, GMGF; Department of Medical Genetics, Childrens’ Hospital La Timone, France (A.D.S.-G., N.L.).

family: Lakdawala

full_name: Neal K. Lakdawala

given: Neal K.

name: Medical Affairs Department, AFM-Telethon, Evry, France (C. Stalens).

family: Stalens

full_name: Caroline Stalens

given: Caroline

name: Centre de reference des maladies rythmiques héréditaires, Bordeaux University Hospital (CHU), IHU Liryc, Electrophysiology and Heart Modeling Institute, fondation Bordeaux Université, Univ. Bordeaux, INSERM U1045, France (F.S.).

family: Sacher

full_name: Frédéric Sacher

name: Université François Rabelais, Cardiology Department, CHU Tours, France (D. Babuty).

family: Babuty

full_name: Dominique Babuty

given: Dominique

name: INSERM, UMR1087, Université de Nantes, L’Institut du Thorax, CHU de Nantes, CIC, Centre de référence pour la prise en charge des maladies rythmiques héréditaires de Nantes, France† (J.-N.T.).

family: Trochu

full_name: Jean-Noel Trochu

given: Jean-Noel

name: Department of Electrophysiology and Pacing, InParys Clinical Research Group, Clinique Ambroise Paré, Neuilly-sur-Seine, France (G.M.).

family: Moubarak

full_name: Ghassan Moubarak

given: Ghassan

name: William Harvey Research Institute, Queen Mary University London, United Kingdom (K.S.).

family: Savvatis

full_name: Kostantinos Savvatis

given: Kostantinos

name: APHP, Hôtel-Dieu Hospital, Centre d’Epidémiologie Clinique, INSERM U1153, Université Paris Descartes - Sorbonne Paris Cité, France (R.P.).

family: Porcher

full_name: Raphaël Porcher

given: Raphaël

name: APHP, Hôpital Raymond Poincaré, Centre de Référence des maladies neuromusculaires Nord-Est-Île de France, Garches (P.L., A.F.).

family: Laforêt

full_name: Pascal Laforêt

given: Pascal

family: Fayssoil

full_name: Abdallah Fayssoil

given: Abdallah

name: Hôpital Européen Georges Pompidou, Département de Cardiologie, Unité de Rythmologie, Paris, France (E.M.).

family: Marijon

full_name: Eloi Marijon

given: Eloi

family: Stojkovic

full_name: Tanya Stojkovic

given: Tanya

family: Béhin

full_name: Anthony Béhin

given: Anthony

family: Leonard-Louis

full_name: Sarah Leonard-Louis

given: Sarah

name: Centre de référence des maladies neuromusculaires AOC, Hôpital Pellegrin, CHU Bordeaux, France (G.S., X.F.).

family: Sole

full_name: Guilhem Sole

given: Guilhem

name: Cardiology Department, University Hospital of Caen, France (F.L.).

family: Labombarda

full_name: Fabien Labombarda

given: Fabien

name: APHP, UF Cardiogénétique et Myogénétique, Centre de Génétique, GH Pitié Salpêtrière, Paris, France (P.R., C.M.).

family: Richard

full_name: Pascale Richard

given: Pascale

family: Metay

full_name: Corinne Metay

given: Corinne

name: APHP, Centre de référence des maladies neuromusculaires Nord/Est/Ile de France, Service de Neurologie, Réanimation et Réeducation Pediatriques, Hôpital Raymond Poincaré, Garches, France; UMR 1179 INSERM, Université Versailles Saint-Quentin–en-Yvelines, Montigny-le-Bretonneux (S.Q.-R., I. Dabaj).

name: Cardiologie A, University Hospital, Lille, France (D.K.).

name: CHU Lille, Endocrinology, Diabetology and Metabolism, Univ Lille, Inserm, UMR 1190 -Translational research in diabetes; EGID European Genomic Institute for Diabetes, France (M.-C.V.).

name: Service de Cardiologie, Hôpital Est, Lyon, France† (P.C.).

name: Department of Cardiology, La Timone Hospital, Aix-Marseille Université, France (P.A.).

name: APHM, Centre de référence des maladies neuromusculaires PACA-Réunion-Rhône Alpes, Hôpital Timone; Aix Marseille Université, Inserm UMR_S 910, GMGF, France (E.S.).

name: Department of Cardiology, Institut Lorrain du Coeur et des Vaisseaux, CHU Nancy-Brabois, Vandoeuvre les Nancy Cedex, France (N.S.).

name: Univ Rennes, CHU Rennes, Inserm, LTSI - UMR 1099, France (P. Mabo, R.M.).

name: Département de Rythmologie, Clinique Pasteur, Toulouse, France (N.C.).

name: University Hospital Rangueil, Cardiology department; Unité Inserm U1048, Toulouse, France (P. Maury).

name: Département de Cardiologie, Centre Hospitalier Universitaire de Nancy; INSERM-IADI U1254, Vandœuvre lès-Nancy, France (J.-M.S.).

name: Department of Cardiology, Division of Medicine (J.M.K., J.V.), The Royal Melbourne Hospital and University of Melbourne, Victoria, Australia.

name: Department of Cardiology, Leiden University Medical Centre, the Netherlands (A.G.A.A., K.Z.).

name: Department of Genetic Medicine (T.T.), The Royal Melbourne Hospital and University of Melbourne, Victoria, Australia.

name: AP-HP, Centre de référence des maladies neuromusculaires Nord/Est/Ile de France, service de neurologie pédiatrique, Hôpital Necker, GH Necker-Enfants malades, Paris, France (C.B., I. Desguerre).

name: Centre de référence des maladies neuromusculaires AOC, Département de Neurologie, Hôpital Purpan, CHU Toulouse, France (B.C.).

name: Service de Génétique Médicale, Hôpital Purpan, CHU Toulouse, France (E.B.).

name: AP-HP, Hôpitaux de l’Est Parisien, Cardiology Unit, Hôpital Saint-Antoine; Sorbonne Universités, INSERM, UMR_S 938, Paris, France (F.B.).

name: Hospices Civils de Lyon, Centre de référence des maladies neuromusculaires PACA-Réunion-Rhône Alpes, Service d’ENMG, Hôpital Neurologique Pierre Wertheimer, Lyon-Bron, France (F.B., P.P.).

name: AP-HP, Unité Médico-Chirurgicale de Cardiologie Congénitale et Pédiatrique, Centre de référence des Malformations Cardiaques Congénitales Complexes-M3C, Hôpital Necker Enfants Malades, Université Paris Descartes, Sorbonne Paris-Cité, France (D. Bonnet).

name: Hôpital privé Le Bois, Service de Cardiologie, Lille, France (S.B.).

name: Unité de Génétique Clinique, CHU Rouen, France (A.-C.B.).

name: Centre de Référence des maladies neuromusculaires Nord/Est/Ile de France, Service de neurologie, CHU Caen; INSERM U1075, Université de Normandie, Caen, France (F.C., S.S.).

name: Centre de Référence des maladies neuromusculaires Nord/Est/Ile de France, Service de Neuropédiatrie, Hôpital Roger Salengro, CHRU Lille (J.-M.C.).

name: Service de Cardiologie, CHU Montpellier, France (J.-M.D.).

name: Centre de Référence Maladies Rares CLAD-Ouest, Service de Génétique Clinique, CHU Rennes, Hôpital Sud, France (F.D., M.F.).

name: Unité de Génétique Clinique, Hôpital Couple Enfant, CHU Grenoble, INSERM U1216, Grenoble Institut des Neurosciences Cellular Myology and Pathologies, France (K.D.).

name: Centre de référence des maladies neuromusculaires AOC, Service de Neuropédiatrie, CHU Angers, France (J.D.).

name: Département de Neurologie, Hôpitaux Universitaires de Strasbourg, France (A.E.-L.).

name: Service de cardiologie, CHU Clermont-Ferrand; CNRS équipe thérapies guidées par l’image, Institut-Pascal, France (R.E.).

name: Basic and Translational Myology Laboratory, UMR8251, Université Paris Diderot/CNRS, France (A.F.).

name: Génétique médicale, CHU Estaing, Clermond-Ferrand, France (C.F.).

name: APHM, pole ENDO, Hôpital la conception; INSERM, INRA, C2VN, Aix Marseille University, France (B.G.).

name: Cardio-Thoracic Surgery Unit and Pathology Department, Rouen University Hospital, France (A.G.).

name: Department of Cardiology, Assistance Publique-Hôpitaux de Paris and INSERM U970, Hôpital Européen Georges Pompidou, Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, France (A.H.).

name: Centre de Référence des maladies neuromusculaires Nord/Est/Ile de France, Service de neuropédiatrie, Hôpital Trousseau, Paris, France (A.I., M. Mayer).

name: APHP, Department of Genetics (I.J., O.L., C. Vatier, C. Vigouroux), Pitié-Salpêtrière University Hospital, Paris, France.

name: Sorbonne University, Inserm U938, Saint-Antoine Research Centre, Institute of Cardiometabolism and Nutrition, Paris, France (I.J., O.L., C. Vatier, C. Vigouroux).

name: APHP, Saint-Antoine University Hospital, Department of Molecular Biology and Genetics, Paris, France (I.J., O.L., C. Vatier, C. Vigouroux).

name: Centre de référence des maladies neuromusculaires AOC, Department of Neurology, CHU Montpellier, France (R.J.M.).

name: CHRU de Tours, Université François Rabelais de Tours, UMR INSERM U1253, Tours, FILNEMUS, French neuromuscular reference centers, France (E.L.).

name: Univ. Lille, Inserm U1167, Institut Pasteur; CHRU de Lille, Department of Cardiology, France (N.L.).

name: Centre de Référence des maladies neuromusculaires Nord/Est/Ile de France, Service de neuropédiatrie, CHU Strasbourg, Hôpital Hautepierre, Hôpitaux Universitaires de Strasbourg, France (V.L.).

name: InParys Clinical Research Group, Clinique Ambroise Paré, Neuilly sur Seine, France (A.L.).

name: Service de Génétique, Hopital Cochin, AP-HP, Paris (F.L.).

name: Centre de Référence des Maladies Neuromusculaires AOC, Laboratoire des Explorations Fonctionnelles, CHU de Nantes, France (A. Magot, Y.P.).

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

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

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

repository_institution: University College London - UCL Discovery

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

repositories_institution: University College London - UCL Discovery

publisher: Ovid Technologies (Wolters Kluwer Health)

location_facility: Centre de référence maladies neuromusculaires ile de France, Hôpital Necker Enfants malades

location_facility: Centre de référence maladies neuromusculaires ile de France, Hôpital Armand Trousseau

location_facility: Centre de référence maladies neuromusculaires ile de France, GH Pitié-Salpêtrière

location_facility: Centre de référence maladies neuromusculaires,CHU d'Angers

location_facility: Centre de référence des maladies neuromusculaires, CHRU Lille

location_facility: Centre de référence des maladies neuromusculaires Ile de France, Hôpital Raymond Poincaré

location_facility: Service d'endocrinologie, diabétologie et endocrinologie de la reproduction, Hôpital Saint Antoine

location_facility: Centre de référence des maladies neuromusculaires, CHU Lyon


title: Adrenomedullin and Outcome in Severe Sepsis and Septic Shock. The AdrenOSS Study.

acronym: AdrenOSS

summary: The aim of this prospective study is to assess the prognostic value of bioactive plasma adrenomedullin (ADM) in 600 patients with severe sepsis or septic shock in an international multicenter study and to validate the findings concerning the association of ADM concentration and the use of vasopressor therapy, organ failure and outcome.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceCitation: Blet A, Deniau B, Santos K, van Lier DPT, Azibani F, Wittebole X, Chousterman BG, Gayat E, Hartmann O, Struck J, Bergmann A, Antonelli M, Beishuizen A, Constantin JM, Damoisel C, Deye N, Di Somma S, Dugernier T, François B, Gaudry S, Huberlant V, Lascarrou JB, Marx G, Mercier E, Oueslati H, Pickkers P, Sonneville R, Legrand M, Laterre PF, Mebazaa A; AdrenOSS-1 Study Investigators. Monitoring circulating dipeptidyl peptidase 3 (DPP3) predicts improvement of organ failure and survival in sepsis: a prospective observational multinational study. Crit Care. 2021 Feb 15;25(1):61. doi: 10.1186/s13054-021-03471-2.

family: Blet

full_name: Alice Blet

given: Alice

family: Deniau

full_name: Benjamin Deniau

given: Benjamin

family: Santos

full_name: Karine Santos

given: Karine

family: van Lier

full_name: Dirk P. T. van Lier

given: Dirk P. T.

family: Azibani

full_name: Feriel Azibani

given: Feriel

family: Wittebole

full_name: Xavier Wittebole

given: Xavier

family: Chousterman

full_name: Benjamin G. Chousterman

given: Benjamin G.

family: Gayat

full_name: Etienne Gayat

given: Etienne

family: Hartmann

full_name: Oliver Hartmann

given: Oliver

family: Struck

full_name: Joachim Struck

given: Joachim

family: Bergmann

full_name: Andreas Bergmann

given: Andreas

family: Antonelli

full_name: Massimo Antonelli

given: Massimo

family: Beishuizen

full_name: Albertus Beishuizen

given: Albertus

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

family: Damoisel

full_name: Charles Damoisel

given: Charles

family: Deye

full_name: Nicolas Deye

given: Nicolas

family: Di Somma

full_name: Salvatore Di Somma

given: Salvatore

family: Dugernier

full_name: Thierry Dugernier

given: Thierry

family: François

full_name: Bruno François

given: Bruno

family: Gaudry

full_name: Stephane Gaudry

given: Stephane

family: Huberlant

full_name: Vincent Huberlant

given: Vincent

family: Lascarrou

full_name: Jean-Baptiste Lascarrou

given: Jean-Baptiste

family: Marx

full_name: Gernot Marx

given: Gernot

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

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Mebazaa A, Geven C, Hollinger A, Wittebole X, Chousterman BG, Blet A, Gayat E, Hartmann O, Scigalla P, Struck J, Bergmann A, Antonelli M, Beishuizen A, Constantin JM, Damoisel C, Deye N, Di Somma S, Dugernier T, François B, Gaudry S, Huberlant V, Lascarrou JB, Marx G, Mercier E, Oueslati H, Pickkers P, Sonneville R, Legrand M, Laterre PF; AdrenOSS-1 study investigators. Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis: the prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock-1 (AdrenOSS-1) study. Crit Care. 2018 Dec 21;22(1):354. doi: 10.1186/s13054-018-2243-2.

ReferenceCitation: Hollinger A, Wittebole X, François B, Pickkers P, Antonelli M, Gayat E, Chousterman BG, Lascarrou JB, Dugernier T, Di Somma S, Struck J, Bergmann A, Beishuizen A, Constantin JM, Damoisel C, Deye N, Gaudry S, Huberlant V, Marx G, Mercier E, Oueslati H, Hartmann O, Sonneville R, Laterre PF, Mebazaa A, Legrand M. Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Kidney in Sepsis and Septic Shock (Kid-SSS) Study. Kidney Int Rep. 2018 Aug 22;3(6):1424-1433. doi: 10.1016/j.ekir.2018.08.006. eCollection 2018 Nov. Erratum in: Kidney Int Rep. 2018 Nov 17;4(1):187.

location_country: Italy Netherlands France Belgium Germany

location_facility: Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Köln

location_facility: Klinik für Anästhesie, Intensivmedizin und Schmerztherapie, HELIOS-Klinikum Erfurt,

location_facility: Klinik für Operative Intensivmedizin und Intermediate Care

location_facility: UMC Radboudziekenhuis, Dept. Intensive Care

location_facility: Medisch Spectrum Twente; Departement of Intensive Care


type: Other Identifier

title: Phase III Multicentric Trial Comparing Accelerated Partial Breast Irradiation (APBI) Versus Standard or Hypofractionated Whole Breast Irradiation in Low Risk of Local Recurrence of Breast Cancer

acronym: SHARE

summary:
The standard treatment for localized breast cancer is based on conservative surgery (when possible) followed by radiation therapy (RT) delivered to the whole breast. The recommended total RT dose is 45 to 50 Gy delivered in 4.5 to 5 weeks followed by a 10 to 16 Gy boost to the tumor bed for 1 to 1.5 weeks. The rationale for the development of APBI was based on the difficulty for many patients to reach RT centers to receive standard whole breast irradiation (WBI) after conservative surgery. APBI offers decreased overall treatment time and several theoretical advantages over WBI, including a decrease in dose delivered to uninvolved portions of the breast and adjacent organs. If equivalence between the two treatments can be shown, then APBI will be considered as a historic evolution in breast cancer management.

In this phase III trial, designed in postmenopausal women >50 years of age, the objective is to compare the effectiveness and safety of APBI compared with whole breast irradiation. This study is also designed to ensure high quality criteria for surgery, pathology and RT techniques in the 3 arms and will allow to provide data on economics and costs.

status: Active, not recruiting

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceCitation: Belkacemi Y, Bourgier C, Kramar A, Auzac G, Dumas I, Lacornerie T, Mége JP, Mijonnet S, Lemonnier J, Lartigau E. SHARE: a French multicenter phase III trial comparing accelerated partial irradiation versus standard or hypofractionated whole breast irradiation in breast cancer patients at low risk of local recurrence. Clin Adv Hematol Oncol. 2013 Feb;11(2):76-83. Review.

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

lead_sponsor: UNICANCER

location_facility: Centre de traitement des Hautes energie - Clinique de l'Europe

intervention_type: Radiation

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Multicenter, Phase 2 Study, to Evaluate Safety and Efficacy of an Acute Lymphoblastic Leukemia (ALL) Intensive Chemotherapy for Adult Lymphoblastic Lymphoma (LL).

summary: The primary objective of this study is to evaluate the safety and the efficacy of an adult "acute lymphoblastic leukaemia" type chemotherapy in patients less than 60 years with lymphoblastic lymphoma. Treatment principle is based on an intensive induction and a delayed intensification.

status: Unknown status

design_allocation: Non-Randomized

ReferenceType: background

ReferenceCitation: Le Gouill S, Lepretre S, Brière J, Morel P, Bouabdallah R, Raffoux E, Sebban C, Lepage E, Brice P. Adult lymphoblastic lymphoma: a retrospective analysis of 92 patients under 61 years included in the LNH87/93 trials. Leukemia. 2003 Nov;17(11):2220-4.

lead_sponsor: Centre Henri Becquerel

location_country: Belgium France

location_facility: Cliniques Universitaires U C L de Mont Godinne

location_facility: Centre Hospitalier de La Region Annecienne

intervention_type: Procedure

status_simplified: Unknown


title: Prediction of Clinical Course in COVID19 Patients Using Unsupervised Classification Approaches of Clinical, Biological and the Multiparametric Signature of the Chest CT Scan Performed at Admission

acronym: COVID-CTPRED

summary:
In the context of the COVID19 pandemic and containment, chest CT is currently frequently performed on admission, looking for suggestive signs and basic abnormalities of COVID19 compatible viral pneumonitis pending confirmation of identification of viral RNA by reverse-transcription polymerase chain reaction(PCR), with a reported sensitivity of 56-88% in the first few days, slightly higher than PCR (60%) (1). Nevertheless, currently established radiological abnormalities are not specific for COVID19 and the specificity of the chest CT is ~25% when PCR is used as a reference (1). Deconfinement and its consequences will complicate the triage of COVID patients and the role of the scanner, with the expected impact of a decrease in the prevalence of infection in the emergency department and an increase in the number of "all-round" patients, including patients with non-COVID viral infiltrates or pneumopathies.

In addition, there are currently no imaging criteria to complement the clinical and biological data that can predict the progression of lung disease from the initial data.

time_perspective: Retrospective

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Assessment of Tele-expertise for Second Medical Opinion on Pathological Diagnosis

summary: The purpose of this study is to determine whether digitalizing pathological slides and let it accessible on a server for a second medical opinion (tele-expertise) would reduce the time to diagnosis.

ReferenceCitation: Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.

ReferenceCitation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.

family: Charrier

full_name: Nathanael Charrier

given: Nathanael

name: the ARS Ile de France telemedicine group

family: Zarca

full_name: Kevin Zarca

given: Kevin

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

given: Isabelle

family: Calinaud

full_name: Christine Calinaud

given: Christine

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMC Health Services Research

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hospitalier de Villeneuve Saint Georges

intervention_type: Device


ReferenceCitation: van Geffen M, Loof A, Lap P, Boezeman J, Laros-van Gorkom BA, Brons P, Verbruggen B, van Kraaij M, van Heerde WL. A novel hemostasis assay for the simultaneous measurement of coagulation and fibrinolysis. Hematology. 2011 Nov;16(6):327-36. doi: 10.1179/102453311X13085644680348.

ReferenceType: result

ReferenceCitation: Ducloy-Bouthors AS, Jude B, Duhamel A, Broisin F, Huissoud C, Keita-Meyer H, Mandelbrot L, Tillouche N, Fontaine S, Le Goueff F, Depret-Mosser S, Vallet B; EXADELI Study Group, Susen S. High-dose tranexamic acid reduces blood loss in postpartum haemorrhage. Crit Care. 2011;15(2):R117. doi: 10.1186/cc10143. Epub 2011 Apr 15.

family: Ducloy-Bouthors

full_name: Anne-Sophie Ducloy-Bouthors

given: Anne-Sophie

family: Jude

full_name: Brigitte Jude

given: Brigitte

family: Duhamel

full_name: Alain Duhamel

given: Alain

family: Broisin

full_name: Françoise Broisin

given: Françoise

family: Huissoud

full_name: Cyril Huissoud

given: Cyril

family: Keita-Meyer

full_name: Hawa Keita-Meyer

given: Hawa

family: Mandelbrot

full_name: Laurent Mandelbrot

given: Laurent

family: Tillouche

full_name: Nadia Tillouche

given: Nadia

family: Fontaine

full_name: Sylvie Fontaine

given: Sylvie

family: Le Goueff

full_name: Françoise Le Goueff

family: Depret-Mosser

full_name: Sandrine Depret-Mosser

given: Sandrine

family: Vallet

full_name: Benoit Vallet

given: Benoit

family: Susen

full_name: Sophie Susen

given: Sophie

journal_name: Critical Care

publisher_dissemination: Springer

publisher_group: Springer

ReferenceCitation: Anne-Sophie Ducloy-Bouthors, Alain Duhamel, Antoine Tournoys, Annabelle, Gisele Debize, Edith Peneau, Brigitte Jude, Benoit Vallet, Dominique De Prost, Cyril Huissoud, Sophie Susen., Hyperfibrinolysis and post-partum haemorrhage induced coagulopathy. 2013, Thrombosis research Volume 131, Supplement S88-89. Accepted BJA-2014-00923.

ReferenceCitation: Goobie SM, Meier PM, Sethna NF, Soriano SG, Zurakowski D, Samant S, Pereira LM. Population pharmacokinetics of tranexamic acid in paediatric patients undergoing craniosynostosis surgery. Clin Pharmacokinet. 2013 Apr;52(4):267-76. doi: 10.1007/s40262-013-0033-1.

family: Goobie

full_name: Susan M. Goobie

given: Susan M.

family: Meier

full_name: Petra M. Meier

given: Petra M.

family: Sethna

full_name: Navil F. Sethna

given: Navil F.

family: Soriano

full_name: Sulpicio G. Soriano

title: Population Pharmacokinetics of Tranexamic Acid in Paediatric Patients Undergoing Craniosynostosis Surgery

ReferenceCitation: Rozen L, Faraoni D, Sanchez Torres C, Willems A, Noubouossie DC, Barglazan D, Van der Linden P, Demulder A. Effective tranexamic acid concentration for 95% inhibition of tissue-type plasminogen activator induced hyperfibrinolysis in children with congenital heart disease: A prospective, controlled, in-vitro study. Eur J Anaesthesiol. 2015 Dec;32(12):844-50. doi: 10.1097/EJA.0000000000000316.

ReferenceCitation: Ducloy-Bouthors AS, Jeanpierre E, Saidi I, Baptiste AS, Simon E, Lannoy D, Duhamel A, Allorge D, Susen S, Hennart B. TRAnexamic acid in hemorrhagic CESarean section (TRACES) randomized placebo controlled dose-ranging pharmacobiological ancillary trial: study protocol for a randomized controlled trial. Trials. 2018 Mar 1;19(1):149. doi: 10.1186/s13063-017-2421-6.

repository_institution: Université de Lille (University Of Lille) - LillOA

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

ReferenceCitation: Bouthors AS, Hennart B, Jeanpierre E, Baptiste AS, Saidi I, Simon E, Lannoy D, Duhamel A, Allorge D, Susen S. Therapeutic and pharmaco-biological, dose-ranging multicentre trial to determine the optimal dose of TRAnexamic acid to reduce blood loss in haemorrhagic CESarean delivery (TRACES): study protocol for a randomised, double-blind, placebo-controlled trial. Trials. 2018 Mar 1;19(1):148. doi: 10.1186/s13063-017-2420-7.

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

location_facility: Centre Hospitalier Maternité Monaco Valenciennes

location_facility: Hospices civils de Lyon CHU-Lyon Croix Rousse

location_facility: Assistance Publique Hôpitaux Paris Hôpital Trousseau

location_facility: Assistance Publique Hôpitaux Paris Hôpital Louis Mourier

location_facility: Hôpital Jeanne de Flandre - CHRU de Lille

title: Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery: a Multicenter Randomized Double Blind Placebo Controlled Therapeutic and Pharmaco-biological Dose Ranging Study (TRACES) for Its Optimal Benefit/Risk

summary: TRACES trial is a multicenter randomized double blind placebo control therapeutic and pharmaco-biological dose ranging study to measure the effect on blood loss reduction of a single intravenous infusion of two doses regimens (standard dose and low dose) of TA administered at the onset of an active PPH (>800mL) during elective or non-emergent CS and to correlate this clinical effect with the biological effect of fibrinolysis inhibition and the pharmacodynamic measure of TA uterine bleeding and venous blood concentration.


title: Randomized Placebo-controlled Trial Comparing Methotrexate vs. Methotrexate/Metformin Association in Rheumatoid Arthritis Patients

summary: Methotrexate (MTX) is the anchor drug for patients with rheumatoid arthritis (RA). Despite its marked efficacy and acceptable side effect profile, about 1/3 of patients failed to reach RA remission. Metformin is the first-line therapy for type 2 diabetes. Its antioxidative and anti-inflammatory properties make it a good candidate for the treatment of inflammatory diseases such as rheumatoid arthritis.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHR Orléans la Source - service de rhumatologie

location_facility: CHU de Limoges - service de rhumatologie

location_facility: CH de Libourne - service de rhumatologie

location_facility: CHU de Toulouse - service de rhumatolgie

location_facility: CHU de Montpellier - service de rhumatologie

location_facility: CHU de Bordeaux - service de rhumatologie

location_facility: CH des Pays de Morlaix - service de rhumatologie


title: MEMENTO-VAScular COmponents of Dementia

acronym: VASCOD

summary: A Multicenter national longitudinal cohort study including at least 800 individuals recruited from French Research Memory Centers and followed up over 36 months and included in Memento.

primary_purpose: Other

location_facility:
AP-HM
Hospices civils de Lyon
CHU de Dijon
CHU de Strasbourg
CHU de Lille
CHU d'Amiens
CHU de Bordeaux - Pellegrin
CHU de Montpellier
AP-HP - Hôpital BROCA
AP-HP - Hôpital LARIBOISIERE


title: Phase II/III Double-blind Randomized Placebo-controlled Trial Assessing the Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk in Subjects With Specific Dysimmunity and Raynaud Phenomenon

acronym: PSSIT

summary: Systemic sclerosis (SSc) is a severe autoimmune disease associating dysimmunity, vasculopathy and fibrosis. No curative treatment is available. Pre-clinical abnormalities can be found such as specific autoantibodies. The association of Raynaud phenomenon and SSc-specific anti-nuclear antibodies is the hallmark of pre-scleroderma subjects, among who around 47% declare a complete disease after five years. The aim of this study is to assess in this particular population the preventive effect of an anti-platelet treatment.

study_start_date_type: Anticipated

status: Not yet recruiting

location_facility: CHU de Limoges - Service de médecine interne

location_facility: CHU de Toulouse - service de médecine interne

location_facility: CH de Mont-de-Marsan - service de rhumatologie

intervention_type: Drug


title: Randomized Clinical Trial of Plasma Exchanges Versus Sham Plasma Exchanges in Disabling Multiple Sclerosis Acute Relapses Refractory to Steroid Treatment

acronym: PLASMASEP

summary: In more than 40 % of multiple sclerosis (MS) patients experiencing relapse, residual disability accumulates in spite of steroid treatment. Plasma exchanges are frequently used but there is no established evidence of their efficacy.

location_facility: Service de Neurologie - Hôpital Pellegrin - CHU de Bordeaux

location_facility: Service de neurologie - CHU de Clermont-Ferrand

location_facility: Service de Neurologie - CHU de Starsbourg


title: Autonomic Nervous System, Fatigue and Intolerance to Physical Training, and Overtraining in High-Level Athletes. A Multicentre Study

summary: Sports training aims to enhance an athlete's performance (overcompensation). To do that, the athlete must go through periods of fatigue and lower performance (overreaching). When the training plan is balanced, this fatigue is short and reversible.If the training load is too heavy or if recuperation periods are too short, it can lead to persistence fatigue that may only be reversible in the long term. This state of fatigue is part of the broader clinical picture of overtraining, which includes stark changes in performance as well as mood and sleep disorders. Many prediction and characterization methods based on biological markers have been evaluated, but they have not been put into practice in sports training due to obstacles such as reliability, interindividual variability and high costs. This study aims to evaluate a new approach based on the variability of an individual's heart rate (RR variability), which is a way of measuring autonomic nervous system (ASN) activity. It is non-invasive, low-cost, and has already proven useful in athlete health monitoring.

location_facility:
CH Albertville Moutiers
CHU de Saint-Etienne
CNSN Centre médical de Prémanon
Université Paris XIII
CHU de Grenoble
CREPS Toulouse Midi Pyrénées
CHU de Pointe à Pitre
CHU de Besançon


title: Oncologic Impact of Pancreatic Fistula After Distal Pancreatectomy for Pancratic Ductal Adenocarcinoma oh the Body and the Tail : a Multicentre Retrospective Cohort Analysis / POPF-DSS (Postoperative Pancreatic Fistula - Disease Specific Survival)

acronym: POPF-DSS

summary: Clinically-relevant post-operative fistula is a major complication after DP, but it did not affect post-operative therapeutic path nor oncologic long-term outcomes. CR-POPF was not a predictive factor for disease recurrence and it was not associated with an increased incidence of peritoneal or local relapse.

ReferenceCitation: Leon P, Giannone F, Belfiori G, Falconi M, Crippa S, Boggi U, Menonna F, Al Sadairi AR, Piardi T, Sulpice L, Gardini A, Sega V, Chirica M, Ravazzoni F, Giannandrea G, Pessaux P, de Blasi V, Navarro F, Panaro F. The Oncologic Impact of Pancreatic Fistula After Distal Pancreatectomy for Pancreatic Ductal Adenocarcinoma of the Body and the Tail: A Multicenter Retrospective Cohort Analysis. Ann Surg Oncol. 2021 Jun;28(6):3171-3183. doi: 10.1245/s10434-020-09310-y. Epub 2020 Nov 6.

family: Leon

full_name: Piera Leon

given: Piera

family: Giannone

full_name: Fabio Giannone

given: Fabio

family: Belfiori

full_name: Giulio Belfiori

given: Giulio

family: Falconi

full_name: Massimo Falconi

given: Massimo

family: Crippa

full_name: Stefano Crippa

given: Stefano

family: Boggi

full_name: Ugo Boggi

given: Ugo

family: Menonna

full_name: Francesca Menonna

given: Francesca

family: Al Sadairi

full_name: Abdul Rahman Al Sadairi

given: Abdul Rahman

family: Piardi

full_name: Tullio Piardi

given: Tullio

family: Sulpice

full_name: Laurent Sulpice

family: Gardini

full_name: Andrea Gardini

given: Andrea

family: Sega

full_name: Valentina Sega

given: Valentina

family: Chirica

full_name: Mircea Chirica

given: Mircea

family: Ravazzoni

full_name: Ferruccio Ravazzoni

given: Ferruccio

family: Giannandrea

full_name: Giusy Giannandrea

given: Giusy

family: Pessaux

full_name: Patrick Pessaux

given: Patrick

family: de Blasi

full_name: Vito de Blasi

given: Vito

family: Navarro

full_name: Francis Navarro

given: Francis

family: Panaro

full_name: Fabrizio Panaro

given: Fabrizio

journal_name: Annals of Surgical Oncology

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


intervention_type: Biological

status: Terminated

lead_sponsor: Gamida Cell ltd

location_country:
United States
France

location_facility:
UCSF Benioff Children's Hospital
Children's National
Hôpital Robert Debré

source: euctr

title: Allogeneic Stem Cell Transplantation of CordIn™, Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells, in Patients With Hemoglobinopathies

summary: CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells composed of ex vivo expanded allogeneic UCB cells. The overall study objectives are to evaluate the safety and efficacy of CordIn™.


title: A Pilot Study of Adherence Assessment With the Travalert™ Dosing Aid in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma Who Are Treated With the Travoprost/Timolol Maleate Fixed Combination Every Evening

acronym: GAS

summary: The purpose of this study is evaluate adherence to DuoTrav® when reinforced by the use of the Travalert™ Dosing Aid.

lead_sponsor: Alcon Research

location_country:
Italy
United Kingdom
France
Netherlands

location_facility: London Maastricht Milan France


title: BioFiber and BioFiber-CM Absorbable Biologic Scaffold for Soft Tissue Repair and Reinforcement Post-Market Surveillance Clinical Study

summary: The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.

lead_sponsor: Tornier, Inc.

location_facility: University of Virginia Sports Medicine and Shoulder Surgery


title: Regenerative Stem Cell Therapy for Stroke in Europe 1

acronym: RESSTORE 1

summary: Stroke is the second leading cause of death in the world population. When not fatal, stroke often results in disability, and secondary health problems affecting not only patients but also their families. Building on emerging preclinical and pilot clinical evidences, RESSTORE will focus on the clinical assessment of regenerative cell therapy to improve stroke recovery and patients quality of life.

lead_sponsor: University Hospital, Grenoble


title: European Research Projects on Rare Diseases Driven by Young Investigators

acronym: EURUSH

summary:
This study aims to characterize Usher patients in order to correlate this data with genetic information.

Tasks:

Standardization and improvement of Usher syndrome diagnosis: refine and elaborate special tests of visual and otological function in association with genotype that enable to determine the most significant markers for Usher disease progression and therapeutic effect.
Perform genotype and phenotype correlations in Usher syndrome patients
Develop and maintain database for phenotypically and genotypically well-characterized patient cohorts, suitable for future therapeutic trials

ReferenceCitation: Sliesoraityte I, Troeger E, Bernd A, Kurtenbach A, Zrenner E. Correlation between spectral domain OCT retinal nerve fibre layer thickness and multifocal pattern electroretinogram in advanced retinitis pigmentosa. Adv Exp Med Biol. 2012;723:471-8. doi: 10.1007/978-1-4614-0631-0_59.

ReferenceCitation: Overlack N, Goldmann T, Wolfrum U, Nagel-Wolfrum K. Gene repair of an Usher syndrome causing mutation by zinc-finger nuclease mediated homologous recombination. Invest Ophthalmol Vis Sci. 2012 Jun 26;53(7):4140-6. doi: 10.1167/iovs.12-9812.

ReferenceCitation: Goldmann T, Rebibo-Sabbah A, Overlack N, Nudelman I, Belakhov V, Baasov T, Ben-Yosef T, Wolfrum U, Nagel-Wolfrum K. Beneficial read-through of a USH1C nonsense mutation by designed aminoglycoside NB30 in the retina. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6671-80. doi: 10.1167/iovs.10-5741. Epub 2010 Jul 29.

ReferenceCitation: Kersten FF, van Wijk E, Hetterschijt L, Bauβ K, Peters TA, Aslanyan MG, van der Zwaag B, Wolfrum U, Keunen JE, Roepman R, Kremer H. The mitotic spindle protein SPAG5/Astrin connects to the Usher protein network postmitotically. Cilia. 2012 Apr 25;1(1):2. doi: 10.1186/2046-2530-1-2.

ReferenceCitation: Overlack N, Kilic D, Bauss K, Märker T, Kremer H, van Wijk E, Wolfrum U. Direct interaction of the Usher syndrome 1G protein SANS and myomegalin in the retina. Biochim Biophys Acta. 2011 Oct;1813(10):1883-92. doi: 10.1016/j.bbamcr.2011.05.015. Epub 2011 Jul 13.

ReferenceCitation: Estrada-Cuzcano A, Koenekoop RK, Senechal A, De Baere EB, de Ravel T, Banfi S, Kohl S, Ayuso C, Sharon D, Hoyng CB, Hamel CP, Leroy BP, Ziviello C, Lopez I, Bazinet A, Wissinger B, Sliesoraityte I, Avila-Fernandez A, Littink KW, Vingolo EM, Signorini S, Banin E, Mizrahi-Meissonnier L, Zrenner E, Kellner U, Collin RW, den Hollander AI, Cremers FP, Klevering BJ. BBS1 mutations in a wide spectrum of phenotypes ranging from nonsyndromic retinitis pigmentosa to Bardet-Biedl syndrome. Arch Ophthalmol. 2012 Nov;130(11):1425-32. doi: 10.1001/archophthalmol.2012.2434.

ReferenceCitation: García-García G, Besnard T, Baux D, Vaché C, Aller E, Malcolm S, Claustres M, Millan JM, Roux AF. The contribution of GPR98 and DFNB31 genes to a Spanish Usher syndrome type 2 cohort. Mol Vis. 2013;19:367-73. Epub 2013 Feb 13.

ReferenceCitation: Vaché C, Besnard T, le Berre P, García-García G, Baux D, Larrieu L, Abadie C, Blanchet C, Bolz HJ, Millan J, Hamel C, Malcolm S, Claustres M, Roux AF. Usher syndrome type 2 caused by activation of an USH2A pseudoexon: implications for diagnosis and therapy. Hum Mutat. 2012 Jan;33(1):104-8. doi: 10.1002/humu.21634. Epub 2011 Nov 16.

ReferenceCitation: Stoetzel C, Laurier V, Davis EE, Muller J, Rix S, Badano JL, Leitch CC, Salem N, Chouery E, Corbani S, Jalk N, Vicaire S, Sarda P, Hamel C, Lacombe D, Holder M, Odent S, Holder S, Brooks AS, Elcioglu NH, Silva ED, Rossillion B, Sigaudy S, de Ravel TJ, Lewis RA, Leheup B, Verloes A, Amati-Bonneau P, Mégarbané A, Poch O, Bonneau D, Beales PL, Mandel JL, Katsanis N, Dollfus H. BBS10 encodes a vertebrate-specific chaperonin-like protein and is a major BBS locus. Nat Genet. 2006 May;38(5):521-4. Epub 2006 Apr 2. Erratum in: Nat Genet. 2006 Jun;38(6):727. Da Silva, Eduardo [corrected to Silva, Eduardo D].

ReferenceCitation: Castelo-Branco M, Mendes M, Sebastião AR, Reis A, Soares M, Saraiva J, Bernardes R, Flores R, Pérez-Jurado L, Silva E. Visual phenotype in Williams-Beuren syndrome challenges magnocellular theories explaining human neurodevelopmental visual cortical disorders. J Clin Invest. 2007 Dec;117(12):3720-9.

ReferenceCitation: Goldmann T, Overlack N, Wolfrum U, Nagel-Wolfrum K. PTC124-mediated translational readthrough of a nonsense mutation causing Usher syndrome type 1C. Hum Gene Ther. 2011 May;22(5):537-47. doi: 10.1089/hum.2010.067. Epub 2011 Mar 25.

lead_sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

location_country: Germany France Portugal Netherlands

location_facility: IBILI- Faculty of Medicine - University of Coimbra, Center for Hereditary Diseases and Visual Neurosciences Laboratory

location_facility: Johannes Gutenberg University of Mainz, Institute of Zoology, Dept. Cell and Matrix Biology Mainz

location_facility: Radboud University Nijmegen Medical Centre, Dept. Otorhinolaryngology

location_facility: CHU, Laboratoire de génétique moléculaire, INSERM

location_facility: AIBILI, 4C - Coimbra Coordinating Centre for Clinical Research


title: A Phase Randomized Open Labelled Controlled Dose Escalation Study of Repeated Administration of "CYT107" (Glyco-r-hIL-7) Added on Antiviral Treatment and Vaccination in HBeAg-negative Chronic Hepatitis B-infected Patients

acronym: CONVERT

summary: This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with anti viral therapy and vaccine in patients with Hepatitis B chronic infection.

lead_sponsor: Cytheris SA

location_country: Italy France

location_facility: Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi

location_facility: Hopital Henri Mendor-Service d'HepatoGastroEnterologie


title: Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device

acronym: SEPTAL-CRT

summary:
This prospective, randomized, single blind, multi-centre study will examine the effect of the right ventricular (RV) lead location in patients implanted with a cardiac resynchronization defibrillator.

Purpose :

To compare the effect of RV mid-septal (RVS) versus RV apical (RVA) lead location on left ventricular reverse remodeling in patients indicated for cardiac resynchronization therapy device (CRT-D) over a period of 6 months and to evaluate the clinical outcome of the RVS versus RVA pacing, over a period of 12 months.

Objectives:

The primary objective is to demonstrate that there is no difference between the two groups (RVA vs. RVS) in the change of left ventricular end systolic volume (LVESV), between baseline and 6 months.

The secondary objectives are to evaluate the percentage of "echo-responders" plus additional clinical and safety outcomes.

This prospective, randomized, multi-centre, single-blind with 2 parallel arms, non-inferiority study will be conducted in approximately 25 study centres in Europe. The patients will be randomized in a 1:1 ratio. A maximum of 416 patients will be enrolled in this study.

All eligible patients will be followed through baseline, randomisation, pre discharge, 1, 6 and 12 months post-implant. Enrolment is expected to be completed in 18 months. The total duration of the study is expected to be approximately 30 months.

ReferenceCitation: Leclercq C, Sadoul N, Mont L, Defaye P, Osca J, Mouton E, Isnard R, Habib G, Zamorano J, Derumeaux G, Fernandez-Lozano I; SEPTAL CRT Study Investigators. Comparison of right ventricular septal pacing and right ventricular apical pacing in patients receiving cardiac resynchronization therapy defibrillators: the SEPTAL CRT Study. Eur Heart J. 2016 Feb 1;37(5):473-83. doi: 10.1093/eurheartj/ehv422. Epub 2015 Sep 15.

family: Leclercq

full_name: Christophe Leclercq

given: Christophe

family: Sadoul

full_name: Nicolas Sadoul

given: Nicolas

family: Mont

full_name: Lluis Mont

given: Lluis

family: Defaye

full_name: Pascal Defaye

given: Pascal

family: Osca

full_name: Joaquim Osca

given: Joaquim

family: Mouton

full_name: Elisabeth Mouton

given: Elisabeth

family: Isnard

full_name: Richard Isnard

given: Richard

family: Habib

full_name: Gilbert Habib

given: Gilbert

family: Zamorano

full_name: Jose Zamorano

given: Jose

family: Derumeaux

full_name: Genevieve Derumeaux

given: Genevieve

family: Fernandez-Lozano

full_name: Ignacio Fernandez-Lozano

given: Ignacio

journal_name: European Heart Journal

oa_colors: green hybrid

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Guidant Corporation

location_country: France Spain

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Centre Hospitalier Universitaire Haut Levêque

location_facility: Centre Hospitalier Régional d'Orléans- Hôpital La Source

location_facility: Centre Hospitalier Universitaire-Charles Nicolle

location_facility: Centre Hospitaler Universitaire Pontchaillou

location_facility: Centre Hospitalier Universitaire de Marseille- Hôpital La Timone

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Nancy- Hôpital Brabois

location_facility: Centre Hospitalier Universitaire de Grenoble- Hôpital Albert Michalon

location_facility: Centre Hospitalier Universitaire de Montpellier- Hôpital Arnaud de Villeneuve

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Centre Hospitalier Universitaire - Hôpital Rangueil


title: Evaluation of the Efficacy of Low-dose Acetylsalicylic Acid on Diarrhea Induced by Anti-cancer Targeted Therapies.

acronym: ASPIDIA

summary:
The mechanisms of action of the side effects associated with targeted therapies are still poorly understood. He was found in patients treated with gefitinib, increased levels of thromboxane B2 and P-selectin Thromboxane B2 is the result of the hydrolysis of thromboxane A2, which is itself obtained from Prostaglandin H2 under the action of the thromboxane synthetase. The thromboxane A2 is produced by platelets and the active pro-thrombotic properties as follows: stimulation of platelets and activation of other increased platelet aggregation.

The selectins are cell adhesion proteins with a role in the adhesion phenomena. P-selectin is expressed by platelets and endothelial cells.

The demonstration of increased plasma levels of thromboxane B2 and P-selectin leaves suggest a role of platelet activation in the occurrence of side effects associated with targeted therapies.

Kanazawa's study was conducted in 39 Japanese patients, trying to assess the value of low-dose acetylsalicylic acid or 100mg per day, that is to say, anti-aggrégantes doses, the occurrence rash and diarrhea induced by gefitinib.

In this study, the group of patients treated with acetylsalicylic acid presented a lower rate of side effects significantly, 58.3% versus 77.8%. The frequency of diarrhea was 18.5% (or 5 patients) in the standard group versus 0% in the group with acetylsalicylic acid. Similarly, it was found a reduction in the occurrence of skin rash, 33.3% or 4 patients in the acetylsalicylic acid group versus 74.1% s, 20 patients in the standard group. Finally, in this study, it was not revealed significant differences in terms of response to treatment with gefitinib (37% in the standard group versus 33% in the group treated with aspirin patient) It does not exist in our knowledge of prospective data evaluating the effect of acetylsalicylic acid on the reduction of side effects associated with targeted in a population of patients of Caucasian-type treatment.

status: Withdrawn

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Léon Bérard
Centre François Baclesse
Centre Hospitalier public du Cotentin
CHU
Centre hospitalier


title: Study of Socio-demographic Factors, Behaviors and Practices Associated With Infection With SARS-CoV-2

acronym: ComCor

summary:
The objective of the study is to identify socio-demographic factors, behaviors and practices associated with infection with SARS-CoV-2 to help determine where and how patients mostly get infected with SARS-CoV-2.

It is a case-control study including :

cases identified by the nationwide system of positive SARS-CoV-2 tests (COVID-19 diagnosis information system, SIDEP) (currently limited to qRT-PCR) and invited to participate by the National Health Insurance (CNAM) which hosts the data from the nationwide test system;
controls included via Ipsos, a polling institute with access to personal data from a panel from which they will include controls matched on age (divided into 10-year categories), gender and geographic area (departement);
cases will be offered to invite a person they live with to participate in the study offering another case-control analysis inside a household. These participants will be required to report the result of the test as recommended by contact tracing guidelines to determine whether they are cases or controls.

Data will be collected via a self-administered online questionnaire. Some of the participants will be called for a complementary telephone questionnaire to measure reliability of online retrieved data and explore more specific aspects of SARS-CoV-2 transmission.

lead_sponsor: Institut Pasteur

location_facility:
Caisse Nationale d'Assurance Maladie
IPSOS


title: Child's Study of the Distant Impact of Posterior Fossa Injury on Motor Skills, Language, Cognitive Functioning, and Social Cognition - a Combination of Clinical Assessments and Brain Imaging

acronym: CervIRM

summary: One of the major complications of posterior fossa surgery is Posterior Fossa Syndrome (PFS). This syndrome is due to a possible complication of surgical excision of a tumor of the cerebellum (4th ventricle) and is characterized by transient postoperative mutism, dysarthria, behavioral, and affective disorders, as well as motor disorders. PFS is thought to be related to axonal lesions. The long-term consequences on the cognitive and psychosocial sphere of PFS have been widely documented. On the other hand, the literature concerning the consequences of this syndrome on language is much restricted. Beyond the language, the role of cerebellum would be central in cognition, some authors even comparing it to a great "conductor" who would underlie the learning of most motor and cognitive automatisms.

time_perspective: Other

lead_sponsor: University Hospital, Angers

location_facility:
CHU Angers
Hôpital Necker
Hôpitaux Saint-Maurice
Institut Curie
Gustave Roussy


title: A Phase II Study Evaluating the Interest to Combine UCPVax a CD4 TH1-inducer Cancer Vaccine and Atezolizumab for the Treatment of Human PapillomaVirus Positive Cancers

acronym: VolATIL

summary:
70% all cases of cervical cancer, 95% of anal cancers and about 70% of oropharyngeal cancers are linked to Human Papillomavirus (HPV) infection. HPV oncogenic proteins are trans-activators of telomerase. Indeed, E6 oncoprotein transactivates the human telomerase (hTert). Our group has conducted a clinical trial (NCT02402842) in advanced squamous cell anal cancer (SCCA) and investigators have shown a correlation between the presence of anti-HPV immunity and anti-telomerase T helpher 1 (TH1) CD4 T cell responses, establishing telomerase as an appropriate antigen in HPV-related cancers.

Tumor-reactive CD4+ T cells have been found to ensure efficient effector Cytotoxic T Lymphocytes (CTL) recruitment at the tumor site. Promoting tumor specific TH1 CD4 activation might be an attractive therapeutic option to enhance anti-PD-1/PD-L1 (Programmed cell Death-1/Programmed cell Death-Ligand1) efficacy. However, no option is currently available to expand tumor specific TH1 lymphocytes in most patients. Then, investigators have identified four novel MHC (Major Histocompatibility Complex) class II-restricted peptides derived from human telomerase reverse transcriptase (TERT) referred as "Universal Cancer Peptides" (UCP). UCPVax is a therapeutic cancer vaccine developed by our team and composed of two separate peptides called UCP2 and UCP4 derived from telomerase. This UCPVax vaccine is currently evaluated in a multicenter phase I/II study in Non Small Lung Cancer (NSCLC) (NCT2818426) and seems to show to be safe and immunogenic.

PD-1/PD-L1 immune checkpoint is a relevant candidate target for immunotherapy in HPV+ cancers, based on the prominent role of PD-1 and its ligand PD-L1 in HPV-driven immune-evasion. There is a strong rational of using PD-1 therapy in HPV+ cancers, however anti-PD-1/PD-L1 treatment induces a limited number of long term responses in HPV disease. Combining anti-PD-1/PD-L1 therapy with an antitumor vaccine gains serious consideration in HPV+ cancers. Indeed, anti-cancer vaccines can induce tumor-specific T cells expansion and activation and therefore restore the cancer-immunity cycle in patients lacking pre-existing anti-tumor responses.

So investigators propose to determine the clinical interest and immunological efficacy of a treatment combining the CD4 helper T-inducer cancer vaccine (UCPVax) with atezolizumab in patients with HPV+ cancers by evaluation of the objective response rate at 4 months according to iRecist criteria.

ReferenceCitation: Kim S, François E, André T, Samalin E, Jary M, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouché O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, De La Fouchardiere C, Smith D, Deberne M, Spehner L, Badet N, Adotevi O, Anota A, Meurisse A, Vernerey D, Taieb J, Vendrely V, Buecher B, Borg C. Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2018 Aug;19(8):1094-1106. doi: 10.1016/S1470-2045(18)30321-8. Epub 2018 Jul 2.

family: Kim

full_name: Stefano Kim

given: Stefano

family: François

full_name: Eric François

given: Eric

family: André

full_name: Thierry André

given: Thierry

family: Samalin

full_name: Emmanuelle Samalin

given: Emmanuelle

family: Jary

full_name: Marine Jary

given: Marine

family: El Hajbi

full_name: Farid El Hajbi

given: Farid

family: Baba-Hamed

full_name: Nabil Baba-Hamed

given: Nabil

family: Pernot

full_name: Simon Pernot

given: Simon

family: Kaminsky

full_name: Marie-Christine Kaminsky

given: Marie-Christine

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Desrame

full_name: Jérôme Desrame

given: Jérôme

family: Zoubir

full_name: Mustapha Zoubir

given: Mustapha

family: Ghiringhelli

full_name: François Ghiringhelli

given: François

family: Parzy

full_name: Aurélie Parzy

given: Aurélie

family: De La Fouchardiere

full_name: Christelle De La Fouchardiere

given: Christelle

family: Smith

full_name: Denis Smith

given: Denis

family: Deberne

full_name: Mélanie Deberne

given: Mélanie

family: Spehner

full_name: Laurie Spehner

given: Laurie

family: Badet

full_name: Nicolas Badet

family: Adotevi

full_name: Olivier Adotevi

family: Anota

full_name: Amélie Anota

given: Amélie

family: Meurisse

full_name: Aurélia Meurisse

given: Aurélia

family: Vernerey

full_name: Dewi Vernerey

given: Dewi

ReferenceCitation: Godet Y, Fabre E, Dosset M, Lamuraglia M, Levionnois E, Ravel P, Benhamouda N, Cazes A, Le Pimpec-Barthes F, Gaugler B, Langlade-Demoyen P, Pivot X, Saas P, Maillère B, Tartour E, Borg C, Adotévi O. Analysis of spontaneous tumor-specific CD4 T-cell immunity in lung cancer using promiscuous HLA-DR telomerase-derived epitopes: potential synergistic effect with chemotherapy response. Clin Cancer Res. 2012 May 15;18(10):2943-53. doi: 10.1158/1078-0432.CCR-11-3185. Epub 2012 Mar 8.

ReferenceCitation: Dosset M, Godet Y, Vauchy C, Beziaud L, Lone YC, Sedlik C, Liard C, Levionnois E, Clerc B, Sandoval F, Daguindau E, Wain-Hobson S, Tartour E, Langlade-Demoyen P, Borg C, Adotévi O. Universal cancer peptide-based therapeutic vaccine breaks tolerance against telomerase and eradicates established tumor. Clin Cancer Res. 2012 Nov 15;18(22):6284-95. doi: 10.1158/1078-0432.CCR-12-0896. Epub 2012 Oct 2.

ReferenceCitation: Dosset M, Vauchy C, Beziaud L, Adotevi O, Godet Y. Universal tumor-reactive helper peptides from telomerase as new tools for anticancer vaccination. Oncoimmunology. 2013 Mar 1;2(3):e23430.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Centre Léon Bérard
Hospices Civils de Lyon
Centre Georges François Leclerc
Institut Curie
CHU de Besançon


title: Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary Fibrosis

acronym: EXPOSOMFPI

summary: Idiopathic Pulmonary Fibrosis(IPF) is the most common idiopathic interstitial lung disease whose cause is unknown. With age and gender, socio-economic factors are the most influential indicators of health. At present there is very little data on socio-economic factors in the IPF. The investigators hypothesize that a lower socio-economic level and / or exposure to various air pollutants may influence the IPF's natural history, including the severity of diagnosis and prognosis of the IPF. The investigators also hypothesize that the deleterious effect of air pollutants is modulated by individual susceptibility (shorter telomeres) and that this effect is related to oxidative stress and shortening of telomeres.

ReferenceCitation: Duchemann B, Annesi-Maesano I, Jacobe de Naurois C, Sanyal S, Brillet PY, Brauner M, Kambouchner M, Huynh S, Naccache JM, Borie R, Piquet J, Mekinian A, Virally J, Uzunhan Y, Cadranel J, Crestani B, Fain O, Lhote F, Dhote R, Saidenberg-Kermanac'h N, Rosental PA, Valeyre D, Nunes H. Prevalence and incidence of interstitial lung diseases in a multi-ethnic county of Greater Paris. Eur Respir J. 2017 Aug 3;50(2). pii: 1602419. doi: 10.1183/13993003.02419-2016. Print 2017 Aug.

ReferenceCitation: Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Müller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schünemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.

family: Raghu

full_name: Ganesh Raghu

given: Ganesh

family: Collard

full_name: Harold R. Collard

given: Harold R.

family: Egan

full_name: Jim J. Egan

given: Jim J.

family: Martinez

full_name: Fernando J. Martinez

given: Fernando J.

family: Behr

full_name: Juergen Behr

given: Juergen

family: Brown

full_name: Kevin K. Brown

given: Kevin K.

family: Colby

full_name: Thomas V. Colby

given: Thomas V.

family: Cordier

full_name: Jean-François Cordier

given: Jean-François

family: Flaherty

full_name: Kevin R. Flaherty

given: Kevin R.

family: Lasky

full_name: Joseph A. Lasky

given: Joseph A.

family: Lynch

full_name: David A. Lynch

given: David A.

family: Ryu

full_name: Jay H. Ryu

given: Jay H.

family: Swigris

full_name: Jeffrey J. Swigris

given: Jeffrey J.

family: Wells

full_name: Athol U. Wells

given: Athol U.

family: Ancochea

full_name: Julio Ancochea

given: Julio

family: Bouros

full_name: Demosthenes Bouros

given: Demosthenes

family: Carvalho

full_name: Carlos Carvalho

given: Carlos

family: Costabel

full_name: Ulrich Costabel

given: Ulrich

family: Ebina

full_name: Masahito Ebina

given: Masahito

family: Hansell

full_name: David M. Hansell

given: David M.

family: Johkoh

full_name: Takeshi Johkoh

given: Takeshi

family: Kim

full_name: Dong Soon Kim

given: Dong Soon

family: King

full_name: Talmadge E. King

journal_name: American Journal of Respiratory and Critical Care Medicine

title: An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management

ReferenceCitation: Raghu G, Rochwerg B, Zhang Y, Garcia CA, Azuma A, Behr J, Brozek JL, Collard HR, Cunningham W, Homma S, Johkoh T, Martinez FJ, Myers J, Protzko SL, Richeldi L, Rind D, Selman M, Theodore A, Wells AU, Hoogsteden H, Schünemann HJ; American Thoracic Society; European Respiratory society; Japanese Respiratory Society; Latin American Thoracic Association. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis. An Update of the 2011 Clinical Practice Guideline. Am J Respir Crit Care Med. 2015 Jul 15;192(2):e3-19. doi: 10.1164/rccm.201506-1063ST. Erratum in: Am J Respir Crit Care Med. 2015 Sep 1;192(5):644. Dosage error in article text.

ReferenceCitation: Cottin V. [French recommendations for idiopathic pulmonary fibrosis: An updated working document for clinicians]. Rev Mal Respir. 2017 Oct;34(8):789-790. doi: 10.1016/j.rmr.2017.09.005. French.

ReferenceCitation: King TE Jr, Pardo A, Selman M. Idiopathic pulmonary fibrosis. Lancet. 2011 Dec 3;378(9807):1949-61. doi: 10.1016/S0140-6736(11)60052-4. Epub 2011 Jun 28. Review.

title: Idiopathic pulmonary fibrosis

ReferenceCitation: Ley B, Collard HR, King TE Jr. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011 Feb 15;183(4):431-40. doi: 10.1164/rccm.201006-0894CI. Epub 2010 Oct 8. Review.

ReferenceCitation: Collard HR, Ryerson CJ, Corte TJ, Jenkins G, Kondoh Y, Lederer DJ, Lee JS, Maher TM, Wells AU, Antoniou KM, Behr J, Brown KK, Cottin V, Flaherty KR, Fukuoka J, Hansell DM, Johkoh T, Kaminski N, Kim DS, Kolb M, Lynch DA, Myers JL, Raghu G, Richeldi L, Taniguchi H, Martinez FJ. Acute Exacerbation of Idiopathic Pulmonary Fibrosis. An International Working Group Report. Am J Respir Crit Care Med. 2016 Aug 1;194(3):265-75. doi: 10.1164/rccm.201604-0801CI. Review.

ReferenceCitation: Ley B, Ryerson CJ, Vittinghoff E, Ryu JH, Tomassetti S, Lee JS, Poletti V, Buccioli M, Elicker BM, Jones KD, King TE Jr, Collard HR. A multidimensional index and staging system for idiopathic pulmonary fibrosis. Ann Intern Med. 2012 May 15;156(10):684-91. doi: 10.7326/0003-4819-156-10-201205150-00004.

ReferenceCitation: Raghu G, Amatto VC, Behr J, Stowasser S. Comorbidities in idiopathic pulmonary fibrosis patients: a systematic literature review. Eur Respir J. 2015 Oct;46(4):1113-30. doi: 10.1183/13993003.02316-2014. Review.

ReferenceCitation: Lantz PM, House JS, Lepkowski JM, Williams DR, Mero RP, Chen J. Socioeconomic factors, health behaviors, and mortality: results from a nationally representative prospective study of US adults. JAMA. 1998 Jun 3;279(21):1703-8.

ReferenceCitation: Gershon AS, Dolmage TE, Stephenson A, Jackson B. Chronic obstructive pulmonary disease and socioeconomic status: a systematic review. COPD. 2012 Jun;9(3):216-26. doi: 10.3109/15412555.2011.648030. Epub 2012 Apr 12. Review.

ReferenceCitation: Lederer DJ, Arcasoy SM, Barr RG, Wilt JS, Bagiella E, D'Ovidio F, Sonett JR, Kawut SM. Racial and ethnic disparities in idiopathic pulmonary fibrosis: A UNOS/OPTN database analysis. Am J Transplant. 2006 Oct;6(10):2436-42. Epub 2006 Jul 26.

location_facility: 002 - Service Explorations Fonctionnelles Respiratoires


title: An Open-label Phase II Pilot Study of Prevention of Perinatal Transmission of HIV-1 Without Nucleoside Reverse Transcriptase Inhibitors

acronym: MONOGEST

summary: The overall goal is to study the feasibility of darunavir/ritonavir (DRV/r) monotherapy as treatment simplification (switch) in pretreated pregnant women, associated with neonatal prophylaxis with nevirapine, constituting a PMTCT strategy without any Nucleoside Reverse Transcriptase Inhibitor (NRTIs) .

ReferenceCitation: Arribas JR, Girard PM, Paton N, Winston A, Marcelin AG, Elbirt D, Hill A, Hadacek MB. Efficacy of protease inhibitor monotherapy vs. triple therapy: meta-analysis of data from 2303 patients in 13 randomized trials. HIV Med. 2016 May;17(5):358-67. doi: 10.1111/hiv.12348. Epub 2015 Dec 28.

ReferenceCitation: Tubiana R, Mandelbrot L, Le Chenadec J, Delmas S, Rouzioux C, Hirt D, Treluyer JM, Ekoukou D, Bui E, Chaix ML, Blanche S, Warszawski J; ANRS 135 PRIMEVA (Protease Inhibitor Monotherapy Evaluation) Study Group. Lopinavir/ritonavir monotherapy as a nucleoside analogue-sparing strategy to prevent HIV-1 mother-to-child transmission: the ANRS 135 PRIMEVA phase 2/3 randomized trial. Clin Infect Dis. 2013 Sep;57(6):891-902. doi: 10.1093/cid/cit390. Epub 2013 Jun 12.

family: Tubiana

full_name: Roland Tubiana

given: Roland

family: Mandelbrot

full_name: Laurent Mandelbrot

given: Laurent

family: Le Chenadec

full_name: Jérome Le Chenadec

given: Jérome

family: Delmas

full_name: Sandrine Delmas

given: Sandrine

family: Rouzioux

full_name: Christine Rouzioux

given: Christine

family: Hirt

full_name: Deborah Hirt

given: Deborah

family: Treluyer

full_name: Jean-Marc Treluyer

given: Jean-Marc

family: Ekoukou

full_name: Dieudonné Ekoukou

given: Dieudonné

family: Bui

full_name: Eda Bui

given: Eda

family: Chaix

full_name: Marie-Laure Chaix

given: Marie-Laure

family: Blanche

full_name: Stéphane Blanche

given: Stéphane

family: Warszawski

full_name: Josiane Warszawski

given: Josiane

family: Ngondi

full_name: J Ngondi

given: J

family: Chernai

full_name: N Chernai

given: N

family: Teglas

full_name: JP Teglas

given: JP

family: Laurent

full_name: C Laurent

given: C

family: Huyn

full_name: P Huyn

given: P

full_name: J Le Chenadec

full_name: S Delmas

given: S

full_name: J Warszawski

family: Muret

full_name: P Muret

family: Baazia

full_name: Y Baazia

given: Y

family: Jeantils

full_name: V Jeantils

given: V

title: Lopinavir/Ritonavir Monotherapy as a Nucleoside Analogue–Sparing Strategy to Prevent HIV-1 Mother-to-Child Transmission: The ANRS 135 PRIMEVA Phase 2/3 Randomized Trial

ReferenceCitation: André-Schmutz I, Dal-Cortivo L, Six E, Kaltenbach S, Cocchiarella F, Le Chenadec J, Cagnard N, Cordier AG, Benachi A, Mandelbrot L, Azria E, Bouallag N, Luce S, Ternaux B, Reimann C, Revy P, Radford-Weiss I, Leschi C, Recchia A, Mavilio F, Cavazzana M, Blanche S. Genotoxic signature in cord blood cells of newborns exposed in utero to a Zidovudine-based antiretroviral combination. J Infect Dis. 2013 Jul 15;208(2):235-43. doi: 10.1093/infdis/jit149. Epub 2013 Apr 4.

ReferenceCitation: Hleyhel M, Goujon S, Delteil C, Vasiljevic A, Luzi S, Stephan JL, Reliquet V, Jannier S, Tubiana R, Dollfus C, Faye A, Mandelbrot L, Clavel J, Warszawski J, Blanche S; ANRS French Perinatal Cohort Study Group. Risk of cancer in children exposed to didanosine in utero. AIDS. 2016 May 15;30(8):1245-56. doi: 10.1097/QAD.0000000000001051.

ReferenceCitation: Mandelbrot L, Tubiana R, Le Chenadec J, Dollfus C, Faye A, Pannier E, Matheron S, Khuong MA, Garrait V, Reliquet V, Devidas A, Berrebi A, Allisy C, Elleau C, Arvieux C, Rouzioux C, Warszawski J, Blanche S; ANRS-EPF Study Group. No perinatal HIV-1 transmission from women with effective antiretroviral therapy starting before conception. Clin Infect Dis. 2015 Dec 1;61(11):1715-25. doi: 10.1093/cid/civ578. Epub 2015 Jul 21.

title: No Perinatal HIV-1 Transmission From Women With Effective Antiretroviral Therapy Starting Before Conception

ReferenceCitation: Valantin MA, Lambert-Niclot S, Flandre P, Morand-Joubert L, Cabiè A, Meynard JL, Ponscarme D, Ajana F, Slama L, Curjol A, Cuzin L, Schneider L, Taburet AM, Marcelin AG, Katlama C; MONOI ANRS 136 Study Group. Long-term efficacy of darunavir/ritonavir monotherapy in patients with HIV-1 viral suppression: week 96 results from the MONOI ANRS 136 study. J Antimicrob Chemother. 2012 Mar;67(3):691-5. doi: 10.1093/jac/dkr504. Epub 2011 Dec 7.

ReferenceCitation: Lambert-Niclot S, Flandre P, Valantin MA, Soulie C, Fourati S, Wirden M, Sayon S, Pakianather S, Bocket L, Masquelier B, Dos Santos G, Katlama C, Calvez V, Marcelin AG. Similar evolution of cellular HIV-1 DNA level in darunavir/ritonavir monotherapy versus triple therapy in MONOI-ANRS136 trial over 96 weeks. PLoS One. 2012;7(7):e41390. doi: 10.1371/journal.pone.0041390. Epub 2012 Jul 25.

title: Similar Evolution of Cellular HIV-1 DNA Level in Darunavir/Ritonavir Monotherapy versus Triple Therapy in MONOI –ANRS136 Trial over 96 Weeks

location_facility: Groupe hospitalier Cochin-Broca- Hôtel Dieu


title: Efficiency Clinical Study of NOVATEX MEDICAL Compression Garments in Patients With Ehlers-Danlos Syndrome

acronym: NOVASED

summary:
Objective of this study is to assess the efficiency of NOVATEX MEDICAL compression garments in patients with an Ehlers-Danlos syndrome (EDS).

To answer this objectif a comparison before/after use of compression garments will be performed for all patients.

lead_sponsor: Novatex Medical

location_facility: Chu de Marseille - Hôpital de La Conception


title: Monitoring of ESR1, PIK3CA and AKT ctDNA Mutations During Real-life Followup of Patients With Metastatic Breast Cancer Treated With Aromatase Inhibitors

acronym: CICLADES

summary:
The estrogen-dependent nature of breast cancer was first reported in 1896 with the publication of George Beatson's observations on the regression of breast cancer following oophorectomy. Endocrine therapy, targeting ER either directly by selective estrogen receptor modulators (SERMs) and pure antagonists or indirectly by aromatase inhibitors (AIs) that block estrogen production, remains the mainstay of treatment of hormone-sensitive breast cancer in the adjuvant and metastatic settings.

Intrinsic (de novo) and acquired endocrine resistance constitutes an important clinical challenge in the treatment of breast cancer and multiple mechanisms are suspected to underlie the emergence of endocrine resistance.

The role of the estrogen receptor (ER), encoded by the ESR1 gene, in normal mammary gland development and the progression of breast cancer is well established. ESR1 mutations, occurring in 10 to 30% of ER-positive metastatic breast cancer resistant to AIs, lead to ligand-independent activation of the ER.

For patients treated with AIs, monitoring of circulating tumour DNA (ctDNA) for ESR1, PIK3CA and AKT1 mutations could permit early detection of resistance to AIs as recently reported during 2016 American Society of Clinical Oncology (ASCO) meeting.

primary_purpose: Diagnostic

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
Clinique Saint Anne
CHU Strasbourg
Institut de cancérologie de Lorraine
Polyclinique de Courlancy
Institut Jean Godinot
Centre d'oncologie Gentilly
CHR Metz-Thionville
Centre Henri Becquerel
Hôpital Claude Bernard
Polyclinique de l'Orangerie

intervention_type: Diagnostic Test


title: Conduct of High Flow Nasal Cannula Oxygen During Acute Hypoxemic Respiratory Failure: a Multicentre Observational Study

acronym: DECIPHEROBS

summary: Although many studies have investigated the clinical benefits of nasal high flow during acute hypoxemic respiratory failure, there is no data (and even less so recommendations) on how to best conduct this technique, including its initiation and its weaning periods. Investigators will assess in a multicenter, observational study, the way clinicians use nasal high flow therapy in patients with acute respiratory failure in order to try identify one or more strategies that may be then compared in an interventional study.

ReferenceCitation: Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Béduneau G, Delétage-Métreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

family: Frat

full_name: Jean-Pierre Frat

given: Jean-Pierre

family: Thille

full_name: Arnaud W. Thille

given: Arnaud W.

family: Mercat

full_name: Alain Mercat

given: Alain

family: Girault

full_name: Christophe Girault

given: Christophe

family: Ragot

full_name: Stéphanie Ragot

given: Stéphanie

family: Perbet

full_name: Sébastien Perbet

given: Sébastien

family: Prat

full_name: Gwénael Prat

given: Gwénael

family: Boulain

full_name: Thierry Boulain

given: Thierry

family: Morawiec

full_name: Elise Morawiec

given: Elise

family: Cottereau

full_name: Alice Cottereau

given: Alice

family: Devaquet

full_name: Jérôme Devaquet

given: Jérôme

family: Nseir

full_name: Saad Nseir

given: Saad

family: Razazi

full_name: Keyvan Razazi

given: Keyvan

family: Mira

full_name: Jean-Paul Mira

given: Jean-Paul

family: Argaud

full_name: Laurent Argaud

given: Laurent

family: Chakarian

full_name: Jean-Charles Chakarian

given: Jean-Charles

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

family: Wittebole

full_name: Xavier Wittebole

given: Xavier

family: Chevalier

full_name: Stéphanie Chevalier

family: Herbland

full_name: Alexandre Herbland

given: Alexandre

family: Fartoukh

full_name: Muriel Fartoukh

given: Muriel

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

family: Tonnelier

full_name: Jean-Marie Tonnelier

given: Jean-Marie

title: High-Flow Oxygen through Nasal Cannula in Acute Hypoxemic Respiratory Failure

ReferenceCitation: Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.

ReferenceCitation: Sztrymf B, Messika J, Mayot T, Lenglet H, Dreyfuss D, Ricard JD. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study. J Crit Care. 2012 Jun;27(3):324.e9-13. doi: 10.1016/j.jcrc.2011.07.075. Epub 2011 Sep 29.

ReferenceCitation: Messika J, Ben Ahmed K, Gaudry S, Miguel-Montanes R, Rafat C, Sztrymf B, Dreyfuss D, Ricard JD. Use of High-Flow Nasal Cannula Oxygen Therapy in Subjects With ARDS: A 1-Year Observational Study. Respir Care. 2015 Feb;60(2):162-9. doi: 10.4187/respcare.03423. Epub 2014 Nov 4.

ReferenceCitation: Roca O, Messika J, Caralt B, García-de-Acilu M, Sztrymf B, Ricard JD, Masclans JR. Predicting success of high-flow nasal cannula in pneumonia patients with hypoxemic respiratory failure: The utility of the ROX index. J Crit Care. 2016 Oct;35:200-5. doi: 10.1016/j.jcrc.2016.05.022. Epub 2016 May 31.

location_facility: Service de Réanimation Médico-Chirurgicale

location_facility: Service de Réanimation Médicale et Resiratoire


title: Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach

acronym: FREEDOM OP

summary:
Over the past years, arterial closure systems have tended to replace manual compression to ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce hemostasis and patient immobilization times, thus enabling early resumption of walking. These devices have contributed extensively to the development of outpatient stays for cardiology, vascular and neuro-radiology procedures.

According to certain studies however, it would appear that arterial closure devices do not present any greater benefits than manual compression in terms of hemostasis and complications. Moreover, the use of increasingly small diameter instruments would tend to render manual compression sufficient. Finally, the use of these devices generates additional costs.

The purpose of our prospective study is to evaluate the feasibility and safety of same-day discharge after manual compression in patients treated for peripheral artery disease by endovascular technique with 5F sheath.

lead_sponsor: Nantes University Hospital

location_facility: AP-HP, Hôpital Européen Georges Pompidou


type: EudraCT Number

title: COlchicine for Left VEntricular Remodeling Treatment in Acute Myocardial Infarction, a Phase II, Multicenter, Randomized, Double Blinded, Placebo Controlled Clinical Trial

acronym: COVERT-MI

summary:
Inflammatory processes have been identified as key mediators of ischemia/ reperfusion injury in ST-segment elevation myocardial infarction. They add additional damage to the myocardium and are associated with clinical adverse events (heart failure and cardiovascular death) and poor myocardial recovery. All the different anti-inflammatory approaches to reduce reperfusion injury have been disappointing.

Colchicine is a well-known substance with potent anti-inflammatory properties. In a recent pilot study performed in 151 acute STEMI patients treated with primary percutaneous coronary intervention(PPCI) Deftereos et al. showed a 50% reduction of infarct size (creatine kinase release) with a short course treatment of colchicine in comparison to placebo.

One mechanism to explain this effect could be the reduction of adverse left ventricular (LV) remodelling. LV remodelling is part of the healing process of myocardium after MI. It is defined as the end diastolic volume (EDV) increase in the first months after MI. Adverse LV remodelling is increased by inflammation and ultimately leads to heart failure.

Our main hypothesis is that colchicine with its anti-inflammatory properties significantly reduces the initiation of adverse LV remodelling, together with a significant reduction of infarct size and microvascular obstruction in comparison to placebo in acute STEMI patients referred for PPCI.

After inclusion and randomisation, patients will receive the first part of their experimental treatment: colchicine or placebo before PCI, then, the second part after PCI and during 5 days. They will be followed up during their hospitalization and until one year. In order to evaluate LV remodelling, two cardiac magnetic resonance studies will be performed during their participation: one during their hospitalization and a second at 3 months. At 1 year, adverse events will be collected by phone.

ReferenceCitation: Mewton N, Roubille F, Bresson D, Prieur C, Bouleti C, Bochaton T, Ivanes F, Dubreuil O, Biere L, Hayek A, Derimay F, Akodad M, Alos B, Haider L, El Jonhy N, Daw R, De Bourguignon C, Dhelens C, Finet G, Bonnefoy-Cudraz E, Bidaux G, Boutitie F, Maucort-Boulch D, Croisille P, Rioufol G, Prunier F, Angoulvant D. Effect of Colchicine on Myocardial Injury in Acute Myocardial Infarction. Circulation. 2021 Sep 14;144(11):859-869. doi: 10.1161/CIRCULATIONAHA.121.056177. Epub 2021 Aug 23.

name: Hôpital Cardiovasculaire Louis Pradel, Clinical Investigation Center, INSERM 1407 and INSERM CarMeN 1060, Hospices Civils de Lyon and Claude Bernard University, Lyon, France (N.M., C.P., T.B., A.H., F.D., L.H., N.E.J, R.D., C.D.B., G.F., E.B.-C., G.R.).

family: Mewton

full_name: Nathan Mewton

given: Nathan

name: PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, CHU de Montpellier, France (F.R., M.A.).

family: Roubille

full_name: François Roubille

given: François

name: Cardiology Division, University Hospital of Mulhouse, Hôpital Emile Muller, Mulhouse, France (D.B.).

family: Bresson

full_name: Didier Bresson

given: Didier

family: Prieur

full_name: Cyril Prieur

given: Cyril

name: Université de Poitiers, CIC Inserm 1402n CHU de Poitiers, France (C.B., B.A.).

family: Bouleti

full_name: Claire Bouleti

given: Claire

family: Bochaton

full_name: Thomas Bochaton

given: Thomas

name: Cardiology Department CHRU de Tours and EA4245 T2i Tours University, France (F.I., D.A.).

family: Ivanes

full_name: Fabrice Ivanes

given: Fabrice

name: Centre Hospitalier Saint-Joseph Saint-Luc, Invasive Cardiology Department, Lyon, France (O.D.).

family: Dubreuil

full_name: Olivier Dubreuil

given: Olivier

name: Institut MITOVASC, CNRS 6015 INSERM U1083, Université d’Angers, Cardiology Division, CHU Angers, France (L.B., F.P.).

family: Biere

full_name: Loïc Biere

given: Loïc

family: Hayek

full_name: Ahmad Hayek

given: Ahmad

family: Derimay

full_name: François Derimay

family: Akodad

full_name: Mariama Akodad

given: Mariama

family: Alos

full_name: Benjamin Alos

given: Benjamin

family: Haider

full_name: Lamis Haider

given: Lamis

family: El Jonhy

full_name: Naoual El Jonhy

given: Naoual

family: Daw

full_name: Rachel Daw

given: Rachel

family: De Bourguignon

full_name: Charles De Bourguignon

given: Charles

name: Pharmacy Department, FRIPHARM-RC (C.D.), Hospices Civils de Lyon, France.

family: Dhelens

full_name: Carole Dhelens

given: Carole

family: Finet

full_name: Gérard Finet

given: Gérard

family: Bonnefoy-Cudraz

full_name: Eric Bonnefoy-Cudraz

given: Eric

family: Bidaux

full_name: Gabriel Bidaux

given: Gabriel

name: UMR 5558 CNRS UCBL Biostatistics Departement (F.B., D.M.-B.), Hospices Civils de Lyon, France.

name: INSERM CarMeN 1060, IRIS Team, Claude Bernard University, Lyon, France (F.B.).

family: Boutitie

full_name: Florent Boutitie

given: Florent

family: Maucort-Boulch

full_name: Delphine Maucort-Boulch

name: CREATIS CNRS 5220 INSERM U1206 Research Lab, Radiology Department, University Hospital/CHU Saint Etienne, France (P.C.).

name: on behalf of the COVERT-MI Study Investigators

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

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

location_facility:
Centre Hospitalier Universitaire Angers
Hôpital Louis Pradel
CHU Arnaud de Villeneuve
CHU de Rangueil
Hôpital Saint Joseph
CHU de Mulhouse
Hôpital Lariboisière AP-HP
CHU de Poitiers
CHRU de Tours
Hôpital de la Croix-Rousse


title: " Digitalization of Neurofunctional Tests Via a Mobile Application, Digital Assessment Multiple Sclerosis (DAMS), for Multiple Sclerosis Patients"

acronym: MSCopilot

summary:
Multiple Sclerosis (MS) is a chronic immune-mediated inflammatory disease with a broad diversity of symptoms and fluctuating progression patterns. Clinical assessments are challenging and are continually reviewed and enhanced. Optimal multiple sclerosis care depends on early detection of disease progression. The Digital self-Assessment for Multiple sclerosis (DAM) mobile program was developed by Ad Scientiam in order to create a robust and clinically validated remote monitoring platform for MS patients and clinicians. The correlation between DAM version 0 (the first iteration of DAMS) and Multiple Sclerosis Functional Composite (MSFC) has been clinically evaluated in a preliminary study in 30 subjects. DAM version 0 and MFSC global scores were correlated. However, the cognition test had a poor reproducibility and clinicians expressed the wish to measure a walking range rather than a walking speed. Even though vision is the main sense impacting all other tests, particularly when interacting with a mobile, visual tests are rarely performed in real life. A new version of DAM version 0, DAMS, was therefore developed with the addition of the Sloan Low Contrast Letter Acuity Test (SLCLAT), the replacement of the walking speed test with a walking distance test and the Paced Auditory Serial Addition Test (PASAT) by a new version of the cognitive test which resembles the Symbol Digit Modalities Test (SDMT).

The hypothesis is that systematic and prospective multi-dimensional data collection of MS disabilities through the DAMS mobile application will refine the quality and accuracy of both clinicians and patients' knowledge of the disease progression and will ultimately improve the current care of patients.

To test this assumption, the statistician will analyze:

The global diagnostic performance of DAMS with (DAMS 4 tests) and without (DAMS 3 tests) the low contrast vision test versus standard MS scales
The test-retest reliability of DAMS' scores at a 15 day interval

lead_sponsor: Ad scientiam

location_facility:
Hôpital La Timone Adulte
Hôpital Saint Hélier
Hôpital Gui de Chauliac
Hôpital Pasteur
Hôpital Charles Nicolle
Hôpital Pitié Salpêtrière
Hôpital Saint-Phllibert
Hôpital Maison Blanche
Hôpital Hautepierre
Hôpital le Bocage


title: Continuous Hyperosomolar Therapy for Traumatic Brain-injured Patients Study Protocol for a Multicenter Randomized Open-label Trial With Blinded Adjudication of Primary Outcome

acronym: COBI

summary:
Traumatic brain injury (TBI) is a major cause of death and severe prolonged disability. Intracranial hypertension (ICH) is a critical risk factor of bad outcomes after TBI. Continuous infusion of hyperosmolar therapy has been proposed for the prevention or the treatment of ICH. Whether an early administration of continuous hyperosmolar therapy improves long term outcomes is uncertain. The aim of the current study is to assess the efficiency and the safety of continuous hyperosmolar therapy in TBI patients.

The COBI trial is the first randomized controlled trial powered to investigate whether continuous hyperosmolar therapy in TBI patients improve long term recovery.

Hypothesis

Patients treated with early continuous hyperosmolar therapy have reduced morbidity and mortality rates compared to those receiving standard care alone after traumatic brain injury.

Research Questions

Does early continuous hyperosmolar therapy reduce morbidity and mortality rates at 3 and 6 months after TBI assessed by the GOSE questionnaire?
Does early continuous hyperosmolar therapy prevent intracranial hypertension?

ReferenceCitation: Roquilly A, Moyer JD, Huet O, Lasocki S, Cohen B, Dahyot-Fizelier C, Chalard K, Seguin P, Jeantrelle C, Vermeersch V, Gaillard T, Cinotti R, Demeure Dit Latte D, Mahe PJ, Vourc'h M, Martin FP, Chopin A, Lerebourg C, Flet L, Chiffoleau A, Feuillet F, Asehnoune K; Atlanrea Study Group and the Société Française d'Anesthésie Réanimation (SFAR) Research Network. Effect of Continuous Infusion of Hypertonic Saline vs Standard Care on 6-Month Neurological Outcomes in Patients With Traumatic Brain Injury: The COBI Randomized Clinical Trial. JAMA. 2021 May 25;325(20):2056-2066. doi: 10.1001/jama.2021.5561.

name: Université de Nantes, CHU Nantes, Pôle anesthésie réanimations, Service d’Anesthésie Réanimation chirurgicale, Hôtel Dieu, Nantes, France

family: Roquilly

full_name: Antoine Roquilly

given: Antoine

name: Department of Anesthesiology and Critical Care, Beaujon Hospital, DMU Parabol, AP-HP Nord, Paris, France

family: Moyer

full_name: Jean Denis Moyer

given: Jean Denis

name: CHU de Brest, Anesthesia and Intensive Care Unit, Brest, France

family: Huet

full_name: Olivier Huet

name: CHU d’Angers, Anesthesia and Intensive Care Unit, Angers, France

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

name: CHU de Tours, Anesthesia and Intensive Care Unit, Tours, France

family: Cohen

full_name: Benjamin Cohen

name: CHU de Potiers, Anesthesia and Intensive Care Unit, Poitiers, France

family: Dahyot-Fizelier

full_name: Claire Dahyot-Fizelier

given: Claire

name: CHU de Montpellier, Anesthesia and Intensive Care Unit, Montpellier, France

family: Chalard

full_name: Kevin Chalard

given: Kevin

name: CHU de Rennes, Anesthesia and Intensive Care Unit, Rennes, France

family: Seguin

full_name: Philippe Seguin

given: Philippe

family: Jeantrelle

full_name: Caroline Jeantrelle

given: Caroline

family: Vermeersch

full_name: Véronique Vermeersch

given: Véronique

family: Gaillard

full_name: Thomas Gaillard

family: Cinotti

full_name: Raphael Cinotti

given: Raphael

family: Demeure dit Latte

full_name: Dominique Demeure dit Latte

given: Dominique

family: Mahe

full_name: Pierre Joachim Mahe

given: Pierre Joachim

family: Vourc’h

full_name: Mickael Vourc’h

given: Mickael

family: Martin

full_name: Florian Pierre Martin

given: Florian Pierre

family: Chopin

full_name: Alice Chopin

given: Alice

family: Lerebourg

full_name: Celine Lerebourg

given: Celine

name: CHU de Nantes, Service de pharmacie, Hôtel Dieu, Nantes, France

family: Flet

full_name: Laurent Flet

given: Laurent

name: DRCI, Departement promotion, cellule vigilances, CHU Nantes, Nantes, France

family: Chiffoleau

full_name: Anne Chiffoleau

given: Anne

name: DRCI, Plateforme de Méthodologie et de Biostatistique, CHU Nantes, Nantes, France

name: Université de Nantes, Université de Tours, INSERM, SPHERE U1246, Nantes, France

family: Feuillet

full_name: Fanny Feuillet

given: Fanny

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

name: for the Atlanrea Study Group and the Société Française d’Anesthésie Réanimation (SFAR) Research Network

family: Beloeil

full_name: Hélène Beloeil

given: Hélène

ReferenceCitation: Roquilly A, Lasocki S, Moyer JD, Huet O, Perrigault PF, Dahyot-Fizelier C, Seguin P, Sharshar T, Geeraerts T, Remerand F, Feuillet F, Asehnoune K; COBI group. COBI (COntinuous hyperosmolar therapy for traumatic Brain-Injured patients) trial protocol: a multicentre randomised open-label trial with blinded adjudication of primary outcome. BMJ Open. 2017 Sep 24;7(9):e018035. doi: 10.1136/bmjopen-2017-018035.

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

location_facility:
CHU Angers
Centre Hospitalier Sainte-Anne
CHU Brest Hopital La Cavale Blanche
CHU Rennes-Hopital Pontchaillou
AP-HP Beaujon
CHU de Nantes
CHU Poitiers
CHU Montpellier
CHU Tours
CHU Toulouse Hôpital Pierre-Paul Riquet


title: Contraceptive Efficacy, Tolerance and Acceptability of a Benzalkonium Chloride Spermicide Cream In Women Aged Over 40 Years of Age

summary: In spite of many advantages of spermicides, there is no contraceptive efficacy study conducted with any spermicide in women aged over 40 years. That is why the aim of this study is to evaluate contraceptive efficacy, tolerance and acceptability of a spermicide with benzalkonium chloride (Pharmatex® cream) in women aged over 40 years.

lead_sponsor: Laboratoire Innotech International

location_country:
Russian Federation
France

location_facility: FSBI "Scientific Center of Obstetrics, Gynecology and Perinatology n.a. V.I. Kulakov"

location_facility: A.I. Yevdokimov Moscow State University of Medicine and Dentistry"

location_facility: Closed Joint-Stock Company "Heirs"/Nasledniki Ltd.

location_facility: I.M. Sechenov First Moscow State Medical University"

location_facility: "The Pirogov Russian National Research Medical University"