title: Linguistic, Anatomic/Metabolic and Biologic Characterisation of the Three Main Variants of Primary Progressive Aphasia : Towards the Rationale for Drug Trials and Specific Language Rehabilitations

acronym: CAPP

summary:
Primary progressive aphasias (PPA) represent a challenging group of degenerative language diseases that has led to growing interest in the scientific and medical community. However, a full-blown cognitive/linguistic, anatomic and biologic characterization of the three main variants remains incomplete given that the available data derive from relatively small patient samples. Such a three-fold characterisation will be an major milestone with the prospective of providing the rationale for therapeutic interventions comprising specific rehabilitations protocols and pharmacological trials.

The present study addresses theses issues in the three PPA main variants through a cross-sectional and longitudinal investigation exploring 1) cognitive/linguistic features, 2) anatomic/metabolic specifications (MRI-VBM, MRI-fiber tracking, functional connectivity - MRI resting state, PET), and 3) biologic aspects (CSF biomarkers, genetic screening).

location_facility: Département de Neurologie - Centre des maladies neurologiques, cognitives et comportementales


type: Other Identifier

type: Other Grant/Funding Number

title: FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction

acronym: FLOWER-MI

summary:
Although current guidelines recommend fractional flow reserve (FFR) to identify haemodynamically relevant coronary lesion(s) in stable patients when evidence of ischaemia is not available (Class I, Level of Evidence: A), no published study has assessed the usefulness of FFR to guide percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) patients with multi-vessel disease (MVD).

The main objective of this study is to determine whether, in STEMI patients with MVD amenable to PCI, the use of FFR in addition to angiography will improve cardiovascular outcomes, compared with the current practice of angiography- guided PCI, by improving the appropriateness of revascularisations by assessing the relevance of non-culprit lesions in the context of STEMI with multivessel coronary artery disease.

The secondary objective is to assess the safety and the cost-effectiveness of the FFR-guided strategy compared to the angiography-guided strategy.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Authors/Task Force members, Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Heart Journal

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (semantic scholar lookup)

host_type: repository

license_normalized: no license

version: submittedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrøm T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.

ReferenceCitation: Ntalianis A, Sels JW, Davidavicius G, Tanaka N, Muller O, Trana C, Barbato E, Hamilos M, Mangiacapra F, Heyndrickx GR, Wijns W, Pijls NH, De Bruyne B. Fractional flow reserve for the assessment of nonculprit coronary artery stenoses in patients with acute myocardial infarction. JACC Cardiovasc Interv. 2010 Dec;3(12):1274-81. doi: 10.1016/j.jcin.2010.08.025.

ReferenceCitation: Engstrøm T, Kelbæk H, Helqvist S, Høfsten DE, Kløvgaard L, Holmvang L, Jørgensen E, Pedersen F, Saunamäki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aarøe J, Jensen SE, Raungaard B, Køber L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71.

ReferenceType: derived

ReferenceCitation: Denormandie P, Simon T, Cayla G, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, le Breton H, Valy Y, Schiele F, Cuisset T, Vanzetto G, Levesque S, Goube P, Nallet O, Angoulvant D, Roubille F, Charles Nelson A, Chatellier G, Danchin N, Puymirat E. Compared Outcomes of ST-Segment-Elevation Myocardial Infarction Patients With Multivessel Disease Treated With Primary Percutaneous Coronary Intervention and Preserved Fractional Flow Reserve of Nonculprit Lesions Treated Conservatively and of Those With Low Fractional Flow Reserve Managed Invasively: Insights From the FLOWER-MI Trial. Circ Cardiovasc Interv. 2021 Nov;14(11):e011314. doi: 10.1161/CIRCINTERVENTIONS.121.011314. Epub 2021 Aug 23.

family: Denormandie

full_name: Pierre Denormandie

given: Pierre

sequence: first

name: AP-HP, Hôpital Saint Antoine, Department of Clinical Pharmacology and Unité de Recherche Clinique (URCEST), Université Pierre et Marie Curie (UPMC-Paris 06), INSERM U-698, Paris, France; French Alliance for Cardiovascular Trials (FACT)

family: Simon

full_name: Tabassome Simon

given: Tabassome

sequence: additional

name: Cardiology Department, Nîmes University Hospital, Montpellier University, Nîmes, France

family: Cayla

full_name: Guillaume Cayla

given: Guillaume

name: French Alliance for Cardiovascular Trials (FACT); Université de Paris, INSERM Unité-1148, and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, France

family: Steg

full_name: Philippe Gabriel Steg

given: Philippe Gabriel

name: Sorbonne Université, ACTION Study group, Institut de Cardiologie (APHP), INSERM UMRS 1166, Hôpital Pitié-Salpêtrière, Paris, France

family: Montalescot

full_name: Gilles Montalescot

given: Gilles

name: Clinical Research Unit Eco Ile de France, Hôpital Hôtel Dieu, AP-HP, Paris, France

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

given: Isabelle

family: Le Bras

full_name: Alicia Le Bras

given: Alicia

name: Univ Rennes, CHU Rennes, Inserm, LTSI - UMR1099, F 35000 Rennes, France

family: Le Breton

full_name: Hervé Le Breton

given: Hervé

name: Department of Cardiology, CH Saint-Louis, La Rochelle, France

family: Valy

full_name: Yann Valy

given: Yann

name: French Alliance for Cardiovascular Trials (FACT); Department of Cardiology, University Hospital Besançon, Besançon, France, EA 3920 University of Burgundy Franche-Comté, Besançon, France

family: Schiele

full_name: François Schiele

given: François

name: ACTION Study Group, Cardiology Department, INSERM UMR1062, INRA UMR1260, Centre Hospitalier Universitaire La Timone, Aix-Marseille University, Marseille, France

family: Cuisset

full_name: Thomas Cuisset

given: Thomas

name: French Alliance for Cardiovascular Trials (FACT); Department of Cardiology, University Hospital, 38000 Grenoble Alpes, France, INSERM, U1039, Radiopharmaceutiques Biocliniques, Grenoble Alpes University, 38000 Grenoble Alpes, France

family: Vanzetto

full_name: Gérald Vanzetto

given: Gérald

name: Cardiovascular Interventional Unit, Division of Cardiology, Department of Medicine, Centre Cardio-Vasculaire, CHU de Poitiers, Poitiers, France

family: Levesque

full_name: Sébastien Levesque

given: Sébastien

name: Department of Cardiology, Centre Hospitalier Sud Francilien, Corbeil Essonne, France

family: Goube

full_name: Pascal Goube

given: Pascal

name: Cardiology Department, Groupe Hospitalier Intercommunal Le Raincy-Montfermeil, Montfermeil, France

family: Nallet

full_name: Olivier Nallet

given: Olivier

name: Cardiology Department and EA4245 T2i, University Hospital of Tours and Tours University, 37000 Tours, France

family: Angoulvant

full_name: Denis Angoulvant

given: Denis

name: Department of Cardiology, Regional University Hospital of Montpellier, Montpellier, France, PhyMedExp, University of Montpellier, INSERM U1046, CNRS UMR 9214, Montpellier, France

family: Roubille

name: Clinical Research Unit and CIC 1418 INSERM, George-Pompidou European Hospital, AP-HP, 75015 Paris, France

name: Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, Department of Cardiology, Université de Paris, Paris, France; AP-HP, Hôpital Saint Antoine, Department of Clinical Pharmacology and Unité de Recherche Clinique (URCEST), Université Pierre et Marie Curie (UPMC-Paris 06), INSERM U-698, Paris, France

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

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

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Compared Outcomes of ST-Elevation Myocardial Infarction Patients with Multivessel Disease Treated with Primary Percutaneous Coronary Intervention and Preserved Fractional Flow Reserve of Non-Culprit Lesions Treated Conservatively and of Those with Low Fractional Flow Reserve Managed Invasively: Insights from the FLOWER MI trial.

ReferenceCitation: Puymirat E, Cayla G, Simon T, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, Gallet R, Khalife K, Morelle JF, Motreff P, Lemesle G, Dillinger JG, Lhermusier T, Silvain J, Roule V, Labèque JN, Rangé G, Ducrocq G, Cottin Y, Blanchard D, Charles Nelson A, De Bruyne B, Chatellier G, Danchin N; FLOWER-MI Study Investigators. Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction. N Engl J Med. 2021 Jul 22;385(4):297-308. doi: 10.1056/NEJMoa2104650. Epub 2021 May 16.

name: From Assistance Publique–Hôpitaux de Paris (AP-HP), Department of Cardiology, Hôpital Européen Georges Pompidou, Université de Paris, INSERM, Paris Centre de Recherche Cardiovasculaire (E.P., D.B., N.D.), AP-HP, Hôpital Saint Antoine, Department of Clinical Pharmacology and Unité de Recherche Clinique, Sorbonne Université, INSERM Unité 698 (T.S.), Université de Paris, INSERM Unité 1148, and Hôpital Bichat, AP-HP (P.G.S.), Sorbonne Université, ACTION Study Group, Institut de Cardiologie (AP-HP), INSERM...

ReferenceCitation: Puymirat E, Simon T, de Bruyne B, Montalescot G, Steg G, Cayla G, Durand-Zaleski I, Blanchard D, Danchin N, Chatellier G; FLOWER-MI study investigators. Rationale and design of the Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction (FLOWER-MI) trial. Am Heart J. 2020 Apr;222:1-7. doi: 10.1016/j.ahj.2019.12.015. Epub 2019 Dec 27.


title: Implication of UNconventionaL T Lymphocytes in Cystic Fibrosis

acronym: UNLOCk

summary:
Cystic fibrosis (CF) is characterized by a decrease in mucociliary clearance, recurrent infections and airway inflammation. This inflammatory process in airway mucosa is persistent, uncontrolled, but, somewhat paradoxically, ineffective for pathogen clearance. Neutrophils are chronically recruited in the airway mucosa by proinflammatory mediators such as Interleukin (IL)-17. However, mechanisms involved in this dysregulated and persistent immune response are not well understood.

In this context, a heterogeneous subpopulation of T lymphocytes called "unconventional T cells" (UTC) should deserve greater attention. UTC play a key role in orchestrating the ensuing innate and adaptive immune responses and they are endowed with numerous regulatory and effector properties. UTC mainly establish residency at mucosal sites, including the lung. To date, however, data related to implication and behavior of UTC during cystic fibrosis are extremely limited.

The hypothesis is that, given UTC properties, their functions and behavior are altered in CF, and thus, these cells could be implicated in persistent inflammation and poor response to infections.

The objective is to study UTC properties and functions in cystic fibrosis using blood and sputum samples of patients with CF, in correlation with comprehensive clinical and microbiological data.

The study will enroll adult patients with CF followed-up at University Hospital of Tours, France. For each patient included, blood and sputum samples will be analyzed during 18 months 1/ from routine tests obtained at steady state and 2/ from tests performed during acute exacerbations. UTC will be explored in blood and sputum using flowcytometry approach, to evaluate their relative abundance, activation/inhibition profile and functions (cytokine production and cytotoxic ability). Correlation will be made with clinical status, with longitudinal comparison across the study period for each patient, and comparison with the other patients and healthy volunteers.

This study will add significant knowledge in CF immunopathology by comprehensively assess UTC presence, functions and activation in CF. Indeed, UTC could be explored for disease progression marker, and, in a long-term perspective, explored for therapeutic interventions aiming at modulating their function (by activating or inhibiting UTC), to reshape lung immune response during CF.

status: Recruiting

study_type: Observational

time_perspective: Prospective

ipd_sharing: Undecided

lead_sponsor: University Hospital, Tours

location_facility: Cystic Fibrosis Resource and Competence Center, University Hospital, Tours

location_facility: Pulmonology Department, University Hospital, Tours

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Prognostic Value of Novel Biomarkers in Patients With Shortness of Breath Attending an Emergency Department

acronym: BIODINER

summary: The purpose of this study is to evaluate the capacity of some novels biomarkers Procalcitonin (PCT), Midregional Proadrenomedullin (MR pro ADM), Midregional pro-atrial natriuretic peptide (MR pro ANP), Copeptin (CT pro arginine vasopressin), Pro endothelin to stratify the risk in severe dyspnea.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: ThermoFisher Scientific Brahms Biomarkers France

location_facility: Emergency department of Pitié Salpetriere Hospital

lead_sponsor_type: industriel

status_simplified: Completed


title: Evaluation of Left Ventricular Pacing Vectors Use in Phrenic Nerve Stimulation Management and Left Ventricular Parameters Adjustment

acronym: ORPHEE

summary: Evaluation of three left ventricular pacing polarities effectiveness to narrow phrenic nerve stimulation.

primary_purpose: Prevention

lead_sponsor: LivaNova

location_facility: CHU Groupe Hospitalo-universitaire Caremeau

intervention_type: Device


title: Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness

acronym: ENS

summary: The purpose of this study is to determine whether early neuromuscular electrical stimulation is effective in the prevention of neuromuscular weakness in critical ill patients.

status: Unknown status

primary_purpose: Supportive Care

ReferenceCitation: Routsi C, Gerovasili V, Vasileiadis I, Karatzanos E, Pitsolis T, Tripodaki E, Markaki V, Zervakis D, Nanas S. Electrical muscle stimulation prevents critical illness polyneuromyopathy: a randomized parallel intervention trial. Crit Care. 2010;14(2):R74. doi: 10.1186/cc8987. Epub 2010 Apr 28.

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

ReferenceCitation: Needham DM, Truong AD, Fan E. Technology to enhance physical rehabilitation of critically ill patients. Crit Care Med. 2009 Oct;37(10 Suppl):S436-41. doi: 10.1097/CCM.0b013e3181b6fa29. Review.

ReferenceCitation: Kho ME, Truong AD, Brower RG, Palmer JB, Fan E, Zanni JM, Ciesla ND, Feldman DR, Korupolu R, Needham DM. Neuromuscular electrical stimulation for intensive care unit-acquired weakness: protocol and methodological implications for a randomized, sham-controlled, phase II trial. Phys Ther. 2012 Dec;92(12):1564-79. doi: 10.2522/ptj.20110437. Epub 2012 Mar 15.

ipd_sharing: No

lead_sponsor: Institut Mutualiste Montsouris

status_simplified: Unknown


title: What is the Allergy Follow-up for Children After Anaphylactic Reaction? AFCAR : Allergy Follow-up for Children After Anaphylactic Reaction

acronym: SAPRA

summary:
Anaphylaxis is an allergic reaction potentially fatal. The treatment is based on injection of epinephrin as soon as possible. Guidelines by the World Allergic Organisation highlight the importance of medical follow-up. This follow-up consists of an allergy consultation, the prescription and demonstration of epinephrin auto-injector and the implementation of specific measures in schools. There is no study about the recurrence of anaphylactic reaction outside the hospital.

The purpose of this study is to evaluate the allergy follow-up of children after anaphylactic reaction. The secondary objective is to evaluate the use of medical advice in case of recurrence of anaphylactic reaction.

Investigators will use a phone call questionnaire for parents of children who underwent an anaphylactic reaction between the 1st July 2014 and the 31st June 2016 treated in the Paediatric Emergency Department in Femme-Mère-Enfant Hospital in Lyon in France. 179 children could be included in the study.

lead_sponsor: Hospices Civils de Lyon


title: Post-market Clinical Follow-up Study Evaluating the Efficacy and Safety of LifeVest in Real-life Settings in France

acronym: WEARIT France

summary: This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings.

ReferenceCitation: Garcia R, Combes N, Defaye P, Narayanan K, Guedon-Moreau L, Boveda S, Blangy H, Bouet J, Briand F, Chevalier P, Cottin Y, Da Costa A, Degand B, Deharo JC, Eschalier R, Extramiana F, Goralski M, Guy-Moyat B, Guyomar Y, Hermida JS, Jourda F, Lellouche N, Mahfoud M, Manenti V, Mansourati J, Martin A, Pasquié JL, Ritter P, Rollin A, Tibi T, Yalioua A, Gras D, Sadoul N, Piot O, Leclercq C, Marijon E. Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study. Europace. 2021 Jan 27;23(1):73-81. doi: 10.1093/europace/euaa268.

name: Department of Cardiology, Poitiers University Hospital, 86021 Poitiers, France

family: Garcia

full_name: Rodrigue Garcia

given: Rodrigue

name: Department of Cardiology, Pasteur Clinic, 33000 Toulouse, France

family: Combes

full_name: Nicolas Combes

given: Nicolas

name: Department of Cardiology, Grenoble University Hospital, 38043 Grenoble, France

family: Defaye

full_name: Pascal Defaye

name: Department of Cardiology, European Georges Pompidou Hospital, 75015 Paris, France

name: University of Paris, PARCC, INSERM, F-75015 Paris, France

name: Cardiology Department, Medicover Hospitals, Hyderabad, India

family: Narayanan

full_name: Kumar Narayanan

given: Kumar

name: Department of Cardiology, Lille University Hospital, 59000 Lille, France

family: Guedon-Moreau

full_name: Laurence Guedon-Moreau

given: Laurence

family: Boveda

full_name: Serge Boveda

given: Serge

name: Department of Cardiology, Nancy University Hospital, 54500 Vandoeuvre-Lès-Nancy, France

family: Blangy

full_name: Hugues Blangy

given: Hugues

name: Department of Cardiology, Hospital Center of Aix, 13080 Aix En Provence, France

family: Bouet

full_name: Jérôme Bouet

given: Jérôme

name: Department of Cardiology, Besançon University Hospital, 25000 Besançon, France

family: Briand

full_name: Florent Briand

given: Florent

name: Department of cardiology, Lyon University Hospital, 69000 Lyon, France

family: Chevalier

full_name: Philippe Chevalier

given: Philippe

name: Department of Cardiology, Dijon University Hospital, 28000 Dijon, France

family: Cottin

full_name: Yves Cottin

given: Yves

name: Department of Cardiology, Saint-Etienne University Hospital, 42000 Saint-Étienne, France

family: Da Costa

full_name: Antoine Da Costa

given: Antoine

family: Degand

full_name: Bruno Degand

given: Bruno

name: Department of Cardiology, University Hospital La Timone, 13000 Marseille, France

family: Deharo

full_name: Jean-Claude Deharo

given: Jean-Claude

name: Department of Cardiology Clermont-Ferrand University Hospital, 63000 Clermont Ferrand, France

family: Eschalier

full_name: Romain Eschalier

given: Romain

name: Department of Cardiology, Bichat Hospital - Claude Bernard, 75877 Paris, France

family: Extramiana

full_name: Fabrice Extramiana

given: Fabrice

name: Department of Cardiology, General Hospital of Oréans, 45000 Orléans, France

family: Goralski

full_name: Marc Goralski

given: Marc

name: Department of Cardiology, Limoges University Hospital, 87000 Limoges, France

family: Guy-Moyat

full_name: Benoit Guy-Moyat

given: Benoit

name: Department of Cardiology, Hospital Center Saint Philibert, 59160 Lomme, France

family: Guyomar

full_name: Yves Guyomar

name: Department of Cardiology, Amiens University Hospital, Amiens, France

family: Hermida

full_name: Jean-Sylvain Hermida

given: Jean-Sylvain

name: Department of Cardiology, General Hospital of Auxerre, 89000 Auxerre, France

family: Jourda

full_name: François Jourda

name: Department of Cardiology, University Hospital Henri Mondor, 94000 Creteil, France

family: Lellouche

full_name: Nicolas Lellouche

name: Department of Cardiology, Hospital Center Sud Francilien, 91100 Corbeil Essonnes, France

family: Mahfoud

full_name: Mohanad Mahfoud

given: Mohanad

name: Department of Cardiology, Jacques Cartier Institute, 91300 Massy, France

name: Department of Cardiology, Brest University Hospital, 29200 Brest, France

name: Department of Cardiology, Fontaine Clinic, 21121 Fontaine-Lès-Dijon, France

name: Department of Cardiology, Montpellier University Hospital, 34000 Montpellier, France

name: Department of Cardiology, Bordeaux University Hospital, 33600 Pessac, France

name: Department of Cardiology, Toulouse University Hospital, 31000 Toulouse, France

name: Department of Cardiology, General Hospital of Cannes, 06150 Cannes, France

name: Department of Cardiology, General Hospital of Angoulême, 16000 Angoulême, France

name: Department of Cardiology, Hopital privé du Confluent, 44000 Nantes, France

name: Department of Cardiology, Cardiology Center of Nord, 93200 Saint Denis, France

name: Department of Cardiology, Rennes University Hospital, 35000 Rennes, France

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

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

location_facility:
Clinique PASTEUR
Hôpital Européen Georges Pompidou


title: Retrospective Study of Singing-voice Disorders and Aerodynamic Profiles in Dysodic Singers

acronym: AeroDysodiaPro

summary:
Singers are over-represented in phoniatric consultation; they present increased risk of developing voice disorders. They represent a specific population among phoniatric patients (specific singing-voice complaints, increased sensitivity to voice). Singing-voice disorder is called dysodia in the same way as dysphonia, which refers to speaking-voice disorders. The diagnosis of dysodia is made after a laryngeal examination and a voice assessment to identify patient's speech and singing difficulties. Most studies on prevalence of voice disorders in singers come from the American continent. Very few descriptions of this population have been made in France.

Voice assessment of dysodic singers includes aerodynamic voice measurements. The use of aerodynamic measurements for the diagnosis of voice pathologies is now widely demonstrated. These parameters include measurements of estimated subglottal pressure (ESGP), phonation threshold pressure (PTP) (minimum pressure to initiate a sound) and oral airflow (OAF). They depend on the level of training of singers and the type of vocal dysfunction. Aerodynamic behaviours of dysodic singers have not yet been described, although they can help to better identify the singer's vocal difficulties and could be essential parameters for targeting more precisely rehabilitation exercises proposed in voice therapy.

This study aims to describe the characteristics of a French population of singers consulting in phoniatrics and their aerodynamic behaviours. Do the singers' aerodynamic parameters (pressure, flow) reflect the dysfunctions in singing voice? Based on results of the literature on speaking and singing non-pathological voice, the investigators hypothesize that during voice assessment, ESGP values will be increased and OAF ones will be decreased over the entire vocal range of the singer in case of voice pathology.

time_perspective: Retrospective

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Lyon Sarcoid Uveitis Cohort

acronym: LUCS

summary:
Sarcoidosis is a systemic disease with unknown etiology. Chronicity of the disease is observed in 1/3 of cases. Five percent of the affected patients are expected to die due to pulmonary worsening. After pulmonary complications, ocular complications are one of the most frequent complications. In hospital setting 2 to 15% of patients who come for initial uveitis diagnosis are after examination due to Sarcoidosis. Sarcoidosis diagnosis is based on paraclinical exams (biological, radiography) and histological confirmation. Corticotherapy (local or general) is usually used to cure sarcoid uveitis. In case of failure immunosuppressor or anti-tumor necrosis factor (TNF) can be used. In 10% of cases ocular symptoms including blindness are observed. Only treatment administrated quickly after diagnosis of sarcoid uveitis can prevent from ophthalmologic complications.

The main objective of the Lyon Sarcoid Uveitis Cohort study is to analyze the relevance of the paraclinical exam for sarcoid uveitis diagnosis, and to define a better visual and extra-ophthalmologic prognosis and describe the therapeutic practice in our Department.

This study is proposed to all patients diagnosed with Sarcoid uveitis with a histological confirmation and referred to the internal medicine department of the Croix-Rousse hospital, Lyon, France, for etiologic diagnosis or treatment.

ReferenceCitation: Danjou W, Pradat P, Jamilloux Y, Gerfaud-Valentin M, Kodjikian L, Trad S, Seve P. Usefulness of the QuantiFERON test for the diagnosis of tubercular uveitis and the predictions of response to antituberculosis treatment. Br J Ophthalmol. 2021 Oct 28. pii: bjophthalmol-2021-318868. doi: 10.1136/bjophthalmol-2021-318868. [Epub ahead of print]

family: Danjou

full_name: William Danjou

given: William

family: Pradat

full_name: Pierre Pradat

given: Pierre

family: Jamilloux

full_name: Yvan Jamilloux

given: Yvan

family: Gerfaud-Valentin

full_name: Mathieu Gerfaud-Valentin

given: Mathieu

family: Kodjikian

full_name: Laurent Kodjikian

given: Laurent

family: Trad

full_name: Salim Trad

given: Salim

family: Seve

full_name: Pascal Seve

given: Pascal

journal_name: British Journal of Ophthalmology

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Cotte P, Pradat P, Kodjikian L, Jamilloux Y, Seve P. Diagnostic value of lymphopaenia and elevated serum ACE in patients with uveitis. Br J Ophthalmol. 2021 Oct;105(10):1399-1404. doi: 10.1136/bjophthalmol-2020-316563. Epub 2020 Sep 11.

family: Cotte

full_name: Philippine Cotte

given: Philippine

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central


title: Determination of Minimal Clinically Important Difference of Allergic Rhinitis Symptoms Due to Grass Pollen by the Assessment of the Relationship Between the Symptom Scores and Global Rating of Change Questionnaires on the Quality of Life and Well-being.

summary: Prospective multi-center study carried out in France involving patients with allergic rhinitis. Study in usual care where no specific diagnostic or therapeutic procedure is required. The patients will be asked to fill in Questionnaires on a daily and weekly basis.

lead_sponsor: Hopital Foch


title: Epidemiology of Congenital Heart Disease in France : EPIDEMIO-CHD

acronym: EPIDEMIO-CHD

summary:
Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Since the 1980s, France has been a pioneer in neonatal CHD surgery (Pr. Fontan, Pr. Lecomte, Pr. Serraf, etc.), in prenatal diagnosis, and in interventional cardiac catheterization.

Actually, first children operated for complex CHD have reached adulthood and a new epidemiology of CHD is emerging. Currently, one of the public health challenges is the need to maintain appropriate follow-up and to avoid disruption of care during the transition from adolescence to adulthood. Thus, the national health authorities (DGOS) recently certified a national network of expert centers for complex CHD (M3C).

In addition, under the leadership of the French Society of Cardiology, the sub-specialty of Pediatric and Congenital Cardiology has been recognized.

However, while North American and North European countries have published their updated data on the main indicators of CHD morbidity and mortality, no study has reported epidemiology of CHD in France.

Currently, available data are approximate, estimating that 200,000 children and 250,000 adults would be living in France with a CHD. Nevertheless, no information is available on hospitalizations, type of CHD, their follow-up, possible disruption in care, and morbidity and mortality in patients with CHD in France. This epidemiological study will use the national health insurance hospital database to answer these questions.


title: Impact of COVID-19 on Unplanned Admissions for Acute Cardiovascular and Neurovascular Conditions in France

acronym: COVUSI

summary:
The COVID-19 pandemic has had dramatic effects on health systems and on non-COVID health care.

Using French inpatient claims data and retrospectively collected clinical data, the investigators will assess the changes in hospital admissions for acute cardiovascular and neurovascular conditions in France during and after the national lockdown.


title: Real or Concieved Death Number Perception in Depression, Anxiety and in Schizotypal Personality Disorder Following Covid-19 Pandemic Lockdown

acronym: DeathPercep

summary:
France has been put on a lockdown for 8 weeks to prevent the spread of the COVID-19 virus between 17/03/2020 and 11/05/2020. During this lockdown, which is likely to have psychopathological repercussions on the population, the public authorities and the media informed the population about the number of deaths occurring each day. While the functioning of autobiographical memory following traumatic events remains a debate in the literature, the impact of the daily announcement of mass deaths on the memory system in the general population and the relationship between long-term memory and delusional thinking in certain psychopathologies have yet to be explored in the literature.

The investigators wish to demonstrate that self-reported recall of recorded deaths may represent this distortion of perception, symptomatic of these pathologies by an on-line questionnaire.


title: Non-interventional Study Describing Epidemiology, Clinical Characteristics, Prognosis and Healthcare Costs of PF-ILD and SSc-ILD Patients in France, 2010-2017

acronym: PROGRESS

summary:
Interstitial lung diseases (ILDs) are a heterogeneous group of disorders, which encompass a wide range of conditions. In some patients with fibrosing ILDs, a progressive phenotype similar to that observed in idiopathic pulmonary fibrosis (IPF) may develop during the course of the disease (PF-ILD), including patients with systemic sclerosis (SSc)-related ILD.

The aim of the study is to estimate the incidence and prevalence and to describe the characteristics of patients diagnosed with non-IPF PF-ILD and SSc-ILD, to describe the natural course of disease, and to explore the correlation between mortality and Forced Vital Capacity (FVC) of the patients with non-IPF PF-ILD.

This study will be based on two data sources: the French national medico administrative database (SNDS) and the ILD cohort from the National French center for rare pulmonary diseases in Lyon, France.

study_start_date_type: Anticipated

ReferenceCitation: Cottin V, Larrieu S, Boussel L, Si-Mohamed S, Bazin F, Marque S, Massol J, Thivolet-Bejui F, Chalabreysse L, Maucort-Boulch D, Jouneau S, Hachulla E, Chollet J, Nasser M. Epidemiology, Mortality and Healthcare Resource Utilization Associated With Systemic Sclerosis-Associated Interstitial Lung Disease in France. Front Med (Lausanne). 2021 Aug 30;8:699532. doi: 10.3389/fmed.2021.699532. eCollection 2021.

family: Cottin

full_name: Vincent Cottin

given: Vincent

family: Larrieu

full_name: Sophie Larrieu

given: Sophie

family: Boussel

full_name: Loic Boussel

given: Loic

family: Si-Mohamed

full_name: Salim Si-Mohamed

family: Bazin

full_name: Fabienne Bazin

given: Fabienne

family: Marque

full_name: Sébastien Marque

given: Sébastien

family: Massol

full_name: Jacques Massol

given: Jacques

family: Thivolet-Bejui

full_name: Françoise Thivolet-Bejui

given: Françoise

family: Chalabreysse

full_name: Lara Chalabreysse

given: Lara

family: Maucort-Boulch

full_name: Delphine Maucort-Boulch

given: Delphine

family: Jouneau

full_name: Stéphane Jouneau

given: Stéphane

family: Hachulla

full_name: Eric Hachulla

given: Eric

family: Chollet

full_name: Julien Chollet

given: Julien

family: Nasser

full_name: Mouhamad Nasser

given: Mouhamad

currency_apc_doaj: USD

journal_name: Frontiers in Medicine

oa_colors: green gold

evidence: oa journal (via doaj)

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ReferenceCitation: Nasser M, Larrieu S, Boussel L, Si-Mohamed S, Bazin F, Marque S, Massol J, Thivolet-Bejui F, Chalabreysse L, Maucort-Boulch D, Hachulla E, Jouneau S, Le Lay K, Cottin V. Estimates of epidemiology, mortality and disease burden associated with progressive fibrosing interstitial lung disease in France (the PROGRESS study). Respir Res. 2021 May 24;22(1):162. doi: 10.1186/s12931-021-01749-1.

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

ReferenceCitation: Nasser M, Larrieu S, Si-Mohamed S, Ahmad K, Boussel L, Brevet M, Chalabreysse L, Fabre C, Marque S, Revel D, Thivolet-Bejui F, Traclet J, Zeghmar S, Maucort-Boulch D, Cottin V. Progressive fibrosing interstitial lung disease: a clinical cohort (the PROGRESS study). Eur Respir J. 2021 Feb 11;57(2). pii: 2002718. doi: 10.1183/13993003.02718-2020. Print 2021 Feb.


title: Therapeutic Education Program Aimed at Improving the Quality of Life of Laryngectomised Patients and Their Close Relatives

acronym: PETAL

summary:
The therapeutic education of patients and their close relations is, as yet, poorly developed in France in the field of oncology, in particular for cancers of the upper aerodigestive tract. In the case of pharyngeal and laryngeal cancer, total laryngectomy associated with radiotherapy remains a reference treatment for advanced stage cancers. This mutilating surgical procedure has a major impact on the patient's life, due to its physical and functional sequelae. Its psychosocial consequences are also important, owing to the biographical disruption and the identity-related metamorphoses associated with illness and its treatment, which alter the quality of life not only of patients, but also of their close relations. Currently, care for laryngectomised patients consists essentially in informing and educating them on certain technical procedures during hospital admission. New voice education can be a long process and often involves the intervention of a speech therapist, who serves as the link between the patient and the hospital care team. These healthcare modalities often insufficiently account for the social, environmental and personal factors that interact in health-related problems.

The aim is to design, implement and evaluate a patient therapeutic education (PTE) programme, for laryngectomised patients and their close relations, aimed at improving their quality of life.

The research will be conducted over three phases:

The first phase, referred to as the "pilot" phase, will include exploratory, observational and retrospective analysis aimed at developing knowledge on the consequences of laryngectomy on the quality of life of patients and their close relations, the strengths and weaknesses of current practice in patient support and the needs expressed by the players involved (patients, relations, professional carers). This analysis will be conducted via interviews with patients and their close relations and focus groups with the healthcare professionals involved in patient care and support (hospital and independent). This first phase will enable the pluridisciplinary design of a therapeutic education programme for laryngectomised patients and their close relations which will be tested in the study's principle coordinating centre. The method defined thus is in keeping with quality criteria set by the HAS specifying that the PTE should focus on the patient, be scientifically justified, and be developed by a pluridisciplinary group reuniting representatives of patients or patient associations.

The second phase, referred to as the prospective intervention "replication" phase, aims at evaluating the programme's transferability and quality in three centres. The centres participating in this second phase already have experience in the development of PTE programmes and will be involved in the workgroup entrusted with the design of the PETAL programme during phase 1.

The third phase, referred to as the "randomised" multicentric comparative intervention phase, should enable us to assess the benefits of the developed PTE programme on the quality of life of patients and their close relations.

This is a pluridisciplinary study via which we hope to improve the quality of life of laryngectomised patients and their close relations through the design and the sustainable deployment of an innovative PTE programme in France and Belgium. This project also aims at reinforcing town-hospital links to improve help, follow-up and support for patients and their close relations, as well as dialogue between healthcare professionals.

lead_sponsor: University Hospital, Caen

location_facility:
Lille Cancer Institute
Lille University Hospital
Caen Cancer Institute
Caen University Hospital


title: Evaluation of Impact of Disease on Quality of Life, Education and Socio-professional Integration of Adults and Parents of Children Living With Sickle- Cell Disease in France

acronym: DREPAtient

summary:
Sickle cell disease (SCD) is the most common genetic disease in France. Its consequences on patient's life-course and quality of life need to be precisely identified among French patients and their family to be able to improve patients care according to their specific needs.

The aim of the study is to accurately describe the impact of SCD on quality of life of patients living in France, or their family (for minor patients). The consequences of the disease on professional life, education and material condition of patients or their parents will be described by the patients themselves.

ReferenceCitation: Crosby LE, Joffe NE, Irwin MK, Strong H, Peugh J, Shook L, Kalinyak KA, Mitchell MJ. School Performance and Disease Interference in Adolescents with Sickle Cell Disease. Phys Disabil. 2015;34(1):14-30.

ReferenceCitation: Dos Santos JP, Gomes Neto M. Sociodemographic aspects and quality of life of patients with sickle cell anemia. Rev Bras Hematol Hemoter. 2013;35(4):242-5. doi: 10.5581/1516-8484.20130093.

ReferenceCitation: Gardner K, Douiri A, Drasar E, Allman M, Mwirigi A, Awogbade M, Thein SL. Survival in adults with sickle cell disease in a high-income setting. Blood. 2016 Sep 8;128(10):1436-8. doi: 10.1182/blood-2016-05-716910. Epub 2016 Jul 20.

ReferenceCitation: Habibi A, Arlet JB, Stankovic K, Gellen-Dautremer J, Ribeil JA, Bartolucci P, Lionnet F; centre de référence maladies rares " syndromes drépanocytaires majeurs ". [French guidelines for the management of adult sickle cell disease: 2015 update]. Rev Med Interne. 2015 May 11;36(5 Suppl 1):5S3-84. doi: 10.1016/S0248-8663(15)60002-9. French.

ReferenceCitation: Chapelon E, Garabedian M, Brousse V, Souberbielle JC, Bresson JL, de Montalembert M. Osteopenia and vitamin D deficiency in children with sickle cell disease. Eur J Haematol. 2009 Dec 1;83(6):572-8. doi: 10.1111/j.1600-0609.2009.01333.x. Epub 2009 Aug 13.

ReferenceCitation: Godeau B, Noël V, Habibi A, Schaeffer A, Bachir D, Galactéros F. [Sickle cell disease in adults: which emergency care by the internists?]. Rev Med Interne. 2001 May;22(5):440-51. Review. French.

ReferenceCitation: LINDENBAUM J, KLIPSTEIN FA. FOLIC ACID DEFICIENCY IN SICKLE-CELL ANEMIA. N Engl J Med. 1963 Oct 24;269:875-82.

ReferenceCitation: Noll RB, Vannatta K, Koontz K, Kalinyak K, Bukowski WM, Davies WH. Peer relationships and emotional well-being of youngsters with sickle cell disease. Child Dev. 1996 Apr;67(2):423-36.

ReferenceCitation: Rees DC, Williams TN, Gladwin MT. Sickle-cell disease. Lancet. 2010 Dec 11;376(9757):2018-31. doi: 10.1016/S0140-6736(10)61029-X. Epub 2010 Dec 3. Review.

ReferenceCitation: Salih KMA. The impact of sickle cell anemia on the quality of life of sicklers at school age. J Family Med Prim Care. 2019 Feb;8(2):468-471. doi: 10.4103/jfmpc.jfmpc_444_18.

ReferenceCitation: Sehlo MG, Kamfar HZ. Depression and quality of life in children with sickle cell disease: the effect of social support. BMC Psychiatry. 2015 Apr 11;15:78. doi: 10.1186/s12888-015-0461-6.

lead_sponsor: Argo Sante

location_facility: Centre de références syndromes drépanocytaires majeurs thalassémie et autres maladies rares du globule rouge et de l'érythropoïése


title: Cardiovascular Risk in General Practice in France

summary: The purpose of this study is to evaluate the proportion of patients which present a high cardiovascular risk estimated by the SCORE scale, in general practice consultations of the 7 French regions (Paris area, North-East, Paris basin, West, South-West, South- East, Mediterranean area)

time_perspective: Cross-Sectional

lead_sponsor: AstraZeneca


title: Feasibility in France of a Mindfulness-based Group Therapy for Adolescents With Chronic Pain

acronym: PEACEFULL

summary: The main objective is to study the feasibility of a program for the management of chronic painful adolescents in meditation groups. This program is an adaptation of the MBI-A (Mindfulness-based intervention for adolescent) program developed in another socio-cultural context (i.e. in Canada). The secondary objectives will be to study the effect of a mindfulness meditation program for adolescents on pain, quality of life, acceptance of pain, functional disability, catastrophism, anxiety-depression, emotional repercussions and acceptance of mindfulness

primary_purpose: Other

ReferenceCitation: Bawa FL, Mercer SW, Atherton RJ, Clague F, Keen A, Scott NW, Bond CM. Does mindfulness improve outcomes in patients with chronic pain? Systematic review and meta-analysis. Br J Gen Pract. 2015 Jun;65(635):e387-400. doi: 10.3399/bjgp15X685297. Review.

ReferenceCitation: Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.

ReferenceCitation: Zenner C, Herrnleben-Kurz S, Walach H. Mindfulness-based interventions in schools-a systematic review and meta-analysis. Front Psychol. 2014 Jun 30;5:603. doi: 10.3389/fpsyg.2014.00603. eCollection 2014.

ReferenceCitation: Hesse T, Holmes LG, Kennedy-Overfelt V, Kerr LM, Giles LL. Mindfulness-Based Intervention for Adolescents with Recurrent Headaches: A Pilot Feasibility Study. Evid Based Complement Alternat Med. 2015;2015:508958. doi: 10.1155/2015/508958. Epub 2015 Dec 22.

ReferenceCitation: Chadi N, McMahon A, Vadnais M, Malboeuf-Hurtubise C, Djemli A, Dobkin PL, Lacroix J, Luu TM, Haley N. Mindfulness-based Intervention for Female Adolescents with Chronic Pain: A Pilot Randomized Trial. J Can Acad Child Adolesc Psychiatry. 2016 Fall;25(3):159-168. Epub 2016 Nov 1.

ReferenceCitation: Ruskin D, Harris L, Stinson J, Kohut SA, Walker K, McCarthy E. "I Learned to Let Go of My Pain". The Effects of Mindfulness Meditation on Adolescents with Chronic Pain: An Analysis of Participants' Treatment Experience. Children (Basel). 2017 Dec 15;4(12). pii: E110. doi: 10.3390/children4120110.

ReferenceCitation: Ruskin DA, Gagnon MM, Kohut SA, Stinson JN, Walker KS. A Mindfulness Program Adapted for Adolescents With Chronic Pain: Feasibility, Acceptability, and Initial Outcomes. Clin J Pain. 2017 Nov;33(11):1019-1029. doi: 10.1097/AJP.0000000000000490.

lead_sponsor: University Hospital, Toulouse


title: Fluid Responsiveness Predicted by a Stepwise PEEP Elevation Recruitment Maneuver in Mechanically Ventilated Patients, a Pilot Study

acronym: STEP-PEEP

summary: Hemodynamic and fluid optimization during perioperative period can reduce postoperative morbidity. The assessment of preload and determination of whether the patient is fluid responsive is still challenging. Static preload indices such as central venous pressure are not accurate to assess fluid responsiveness contrary to dynamic preload indices such as pulse pressure variation (PPV) and stroke volume (SV) variation. However, such indices suffer from several limitations and should be used under strict conditions. Alternative dynamic methods such as lung recruitment maneuvers (LRM) have been developed LRM can be used to reopen or prevent collapsed lung under mechanical ventilation so as to decrease respiratory complications. LRM induces a transient increase in intra-thoracic pressure and decreases in venous return, leading to a decrease in left ventricular end-diastolic area and stroke volume. Several studies have shown that the PEEP-induced decrease in stroke volume is related to pre-existing preload responsiveness. Few studies have also shown that LRM can represent a functional test to predict fluid responsiveness. However, monitoring stroke volume during LRM to assess fluid responsiveness is costly, and cardiac output devices may not be reliable. In this context, central venous pressure (CVP) or systemic arterial parameters monitoring are easily accessible and inexpensive during major surgery.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Procedure


title: Perceptions, Representations and Experiences of Malaria Prophylaxis in Patients Born in Endemic Areas and Living in France.

acronym: PREPAP

summary:
The aim of this study is to analyze the perceptions, representations and expe-riences of malaria prophylaxis in patients born in endemic areas and living in France.

This analysis could lead to better understanding and communication between the medical profession and patients in malaria. It would also provide patient-specific responses to their expectations, as to their families.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre hospitalier intercommunal de Villeneuve St Georges


title: Evaluation of the Improvement of Autonomic Nervous System by a Physical Rehabilitation Program Adapted to Adulthood After Chemotherapy or Radiotherapy in Childhood

summary:
Survival rate of childhood cancers is now reaching 80%. However, early or late complications related to surgery, chemotherapy and radiotherapy remain high and greatly increase the risk of late mortality.

Health of individuals is closely correlated to the stability of the autonomic nervous system (ANS), a key system for maintaining homeostasis in any living species. Efficient computer tools allowed the opportunity to assess the intrinsic autonomic regulation of the ANS either directly or at a later time by an analysis of the heart rate variability (HRV). These tools have become very powerful predictors of cardiovascular morbidity and neurological aging. Physical endurance training improves both maximal aerobic capacity and ANS activity.


title: Prevalence and Risk Factors for Coxiella Burnetii Seropositivity (Q Fever) Among Adults in Western France

acronym: MEDVETFQ

summary:
Diseases naturally transmitted between animals and humans (zoonoses) are one of the leading causes of emergence or re-emergence of human infectious diseases. Non-foodborne zoonoses are commonly transmitted to human directly by contact with infected animals or contaminated environment. People working with animals such as farmers and veterinarians are particularly at risk of infection. Some zoonoses can also be transmitted indirectly thought the air and therefore can affect the general population. Example is Q fever, a disease caused by Coxiella burnetii, a bacterium highly resistant in the environment.

In Western France, Q fever is endemic in cattle herds. To improve human zoonotic disease surveillance, the investigators will conduct a population based study in this area.

The aims of the study are:

To assess seroprevalence of Coxiella burnetii infection among general population, farmers and veterinarians in Western France
To identify risk factors for Coxiella burnetii seropositivity in these populations

lead_sponsor: Nantes University Hospital


title: Setting up a Website in Paediatric Surgery at the Rouen University Hospital for Parents and Children to Better Understand the Postoperative Prescription of Painkillers.

acronym: DOLIPAR

summary: Although outpatient surgery is increasing in France, particularly in paediatrics, compliance with analgesics prescriptions and pain management on return home remain poorly controlled parameters, although they are essential for optimal care. This is due, among other things, to parents' lack of knowledge and fears about the medicines prescribed to them. The paediatric anaesthesia unit of the Rouen University Hospital has set up a website for families to improve understanding of and compliance with the prescription of painkillers and thus improve the management of postoperative pain.

status: Not yet recruiting

lead_sponsor: University Hospital, Rouen


title: Cross-cultural Adaptation and Validation of the Pelvic Girdle Questionnaire in French Language

acronym: PELVIC

summary: The objective of this study is the adaptation of the Pelvic Girdle Questionnaire to the French language from France, and the analysis of its psychometric properties. Firstly, a translation and adaptation process will be performed according to international guidelines. Secondly, the validation process will be performed through a sample of 250 pregnant or postpartum women suffering from pelvic girdle pain. They will fill several questionnaires, including Pelvic Girdle Questionnaire, that will allow us to analyse psychometric properties of the French version.

location_facility:
Pôle de Santé de la Grâce de Dieu
Caen University Hospital


title: Validation and Standardisation of a Pool of Simplified Evaluation Aimed to the Diagnoses of Aphasic Disorders and Adapted to the Patients Suffering an Acute Phase of Stroke

acronym: BESTA-AVC

summary:
Every year in France, from 100 000 to 145 000 people are affected by a stroke. 75% patients survived with aftereffects, in particular aphasic disorders.

A sketch of a new tool called BESTA aiming to a rapid handover to the acute phase post stroke had been worked out. After a meeting, 13 multidisciplinary experts have discussed, adjusted and a new complete tool (BESTA) had been created in order to evaluate the different states of aphasia.

The goal of this study is the validation and the standardization of this new BESTA tool.

lead_sponsor: University Hospital, Limoges


title: Kidney Transplant Outcome and Organ Acceptance Practice Pattern: A Nationwide Analyses in the US and France

acronym: USFRKT

summary:
Despite the considerable advances in short-term outcomes, kidney transplant recipients continue to suffer from late allograft failure, and little improvement has been made over the past 15 years. The worldwide scarcity of donated kidneys and the decline in the number of living donor transplants have prompted a variety of efforts to expand the organ supply, such as accepting organs from donors who were older or had comorbidities or other injuries.

Two major initiatives from the United Network for Organ Sharing (UNOS), the organization responsible for organ allocation in the US, failed to improve the kidney acceptance rate. First, UNOS introduced the Kidney Donor Risk Index (KDRI) for all kidney offers in 2012. The KDRI is a score that predicts survival of deceased donor kidneys based on 10 donor characteristics and was intended to simplify the process of judging organ quality for clinicians. Second, in 2014, UNOS changed the kidney allocation system so that lower-quality kidneys are offered over wider geographic areas. Despite the ongoing severe organ shortage and these allocation initiatives, the number of discarded kidneys rose from 2,127 (14.9%) in 2006 to 3,631 (20%) in 2016. In this context, the experience of transplant programs outside the US could offer novel approaches to making organ utilization more efficient through the examination of the disposition of organs that are usually discarded in the US.

This project aims:

To evaluate the potential benefit of transplanting kidneys that would have been discarded otherwise in the US
Computer simulation models on real life data to estimate the number of kidney transplants that would have taken place using data from a nationwide cohort study in two countries (France, the US);
To evaluate the potential gains in allograft survival years that would result in the US from a less restrictive kidney acceptance practice such as the one from France.

time_perspective: Other

ReferenceCitation: Aubert O, Reese PP, Audry B, Bouatou Y, Raynaud M, Viglietti D, Legendre C, Glotz D, Empana JP, Jouven X, Lefaucheur C, Jacquelinet C, Loupy A. Disparities in Acceptance of Deceased Donor Kidneys Between the United States and France and Estimated Effects of Increased US Acceptance. JAMA Intern Med. 2019 Oct 1;179(10):1365-1374. doi: 10.1001/jamainternmed.2019.2322.

apc_source: openAPC

name: Paris Translational Research Center for Organ Transplantation, INSERM, UMR-S970, Paris, France

name: Department of Kidney Transplantation, Necker Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France

family: Aubert

full_name: Olivier Aubert

given: Olivier

name: Department of Medicine, Renal-Electrolyte and Hypertension Division, University of Pennsylvania, Philadelphia

name: Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia

family: Reese

full_name: Peter P. Reese

given: Peter P.

name: Agence de la Biomédecine, Saint Denis la Plaine, France

family: Audry

full_name: Benoit Audry

given: Benoit

name: Department of Nephrology and Kidney Transplantation, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France

family: Bouatou

full_name: Yassine Bouatou

given: Yassine

family: Raynaud

full_name: Marc Raynaud

given: Marc

family: Viglietti

full_name: Denis Viglietti

given: Denis

family: Legendre

full_name: Christophe Legendre

given: Christophe

family: Glotz

full_name: Denis Glotz

family: Empana

full_name: Jean-Phillipe Empana

given: Jean-Phillipe

family: Jouven

full_name: Xavier Jouven

given: Xavier

family: Lefaucheur

full_name: Carmen Lefaucheur

given: Carmen

name: INSERM U1018, CESP, Université Paris Sud, Villejuif, France

family: Jacquelinet

full_name: Christian Jacquelinet

given: Christian

family: Loupy

full_name: Alexandre Loupy

given: Alexandre

journal_name: JAMA Internal Medicine

repository_institution: PubMed Central - Europe PMC

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

location_country:
United States
France

location_facility: Kidney Transplantation Care at Veteran's Affairs Medical Center


title: Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France

acronym: SALTO

summary:
Childhood cancers are rare, and today 75% of patients survive them. An estimated one out of 850 French persons has survived childhood cancer. However, the complications of chemotherapy, radiotherapy or surgery can lead to a higher risk of secondary mortality, which the literature estimates is at 14%. Regular care has a positive impact on the quality of life and health of adults who survived cancer during their childhoods. It aims to detect the potential long-lasting effects of cancer and to provide therapeutic education and psychological care. Thanks to cancer registries, several countries (USA, Canada, UK, Germany, the Netherlands) have developed long-term care structures which function with specially trained adult medicine practitioners. There are only two structures in France: the Long-Term Oncology/Hematology Follow-Up Clinic, headed by Dr François Pein, in Nantes (France), and the LEA program for the follow-up of children treated for leukemia in the PACA-Corse and Lorraine regions of France, which began in 2003 and has since been extended to other centers.

The Rhône-Alpes and Auvergne regions have had childhood cancer registries since 1987; they compile about 200 new cases a year. The Rhône-Alpes registry has conducted a preliminary trial on children (0-15 years old) diagnosed with cancer between 1987 and 1992. They analyzed the correlation between patients' quality of life and the long-term medical effect of cancer and treatment, both recorded in patients' medical files and declared by patients. These young adults who survived pediatric cancer appear to suffer from and declare many complications, although this does not impact their global quality of life much. There is a negative correlation between the number of complications (observed or declared) and the global quality of life score, but only three types of complications play a significant role (motor function complications, auditory complications, and alopecia.) In addition, there is a significant mismatch between patients's perceived health (what they say they experience), and the information contained in their medical files. These young adults expressed the need for their impressions to be better taken into account by health care professionals. This study does not assess patients' psychopathological characteristics.

location_facility:
CHU de Grenoble
CHU de Clermont-Ferrand
CHU de Saint-Etienne
IHOP


title: Medically Assisted Procreation and Choice of the Embryo: How Far Would French People Like to go - An Opinion Survey Among Patients Resorting to in Vitro Fertilization (IVF) in France.

summary:
In today's context of bioethics laws revision concerning Medically Assisted Procreation, the investigators focus on the opinion of couples resorting to In Vitro Fertilization on a fundamental, much debated issue ; the choice of the embryo.

French lawmakers fear the investigators might be drifting towards embryo selection procedures, but no study allows us to state this is what patients request. This study aims at determining, among the population of patients who resort to Medically Assisted Procreation in France, the ratio of patients who are willing to select the embryo due to its genetic characteristics.

status: Enrolling by invitation


title: Economic Evaluation of Innovative Molecular Analyses in Onco-haematology (PRME-K 2016)

summary: To evaluate the impact of innovative molecular diagnostics on the clinical management of patients with haematological malignancies via updated Appropriate-Prescribing-Guides including Next-Generation Sequencing (NGS) panels, facilitated therapeutic orientation, and optimised use of costly novel therapeutics and risk-adapted treatment. A micro-costing approach will be used to develop flat fee tarifs for NGS analyses.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre hospitalier universitaire de Saint-Étienne

location_facility: Centre hospitalier régional universitaire de Lille


title: Impact of E-reporting by Patients With Relapsing-remitting Multiple Sclerosis on the Reporting of Adverse Drug Reactions in France: a Randomized Controlled Trial.

acronym: VigiP-SEP

summary:
Adverse drug reactions are collected exhaustively during the experimental development phase of the drug, but the trial population is not representative. In post-marketing authorization, the use in the real life of medicines requires to specify the profile of adverse effects through pharmacovigilance. However, in clinical practice, under-reporting of adverse drug reactions prevents a satisfactory knowledge of the risks. For example, in the multiple sclerosis (MS) patients population in 2015, only 1 case of congestive flushing was reported by physicians, none by patients, for approximately 7,800 patients treated with Tecfidera® dimethyl-fumarate, while trials reported 39% of flush.

The investigators propose a study measuring the impact of the deployment of e-reporting to patients in a population suffering from multiple sclerosis in initiation of first line drug therapy. The study design will be a randomized controlled trial. Twenty-four direct or indirect partner centers of the OFSEP will be randomized in 2 arms (1 standard arm without intervention, and one interventional arm), Each arm including 6 CHU, 3 CHG and 3 liberal neurologists. CHUs will include 10 patients in 6 months, and CHGs and liberal neurologists 5 patients, a total of 180 patients will be included. The expected duration of this study is 12 months, 6 months of inclusion of patients, and one 6-month follow-up period for each patient. At 1 month (+/- 15 days) of the follow-up period of each patient, a questionnaire will be made by telephone call to each patient.

The study is part of the pharmacovigilance system in place in France and aims to improve its efficiency by increasing declarations and therefore earlier detection of signals in order to prevent and minimize risks.

The comparison of the two arms should make it possible to decide on the usefulness of national support for e-reporting, while respecting a good integration with the French pharmacovigilance system.

ReferenceCitation: Defer G, Fedrizzi S, Chevanne D, Montastruc F, Briant AR, Parienti JJ, Peyro-Saint-Paul L; French VigipSEP Study Group; Société Francophone de la Sclérose en Plaques (SFSEP). Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial. Drug Saf. 2021 Feb;44(2):223-233. doi: 10.1007/s40264-020-01009-z. Epub 2020 Oct 13.

family: Defer

full_name: Gilles Defer

given: Gilles

family: Fedrizzi

full_name: Sophie Fedrizzi

given: Sophie

family: Chevanne

full_name: Damien Chevanne

given: Damien

family: Montastruc

full_name: François Montastruc

given: François

family: Briant

full_name: Anais R. Briant

given: Anais R.

family: Parienti

full_name: Jean-Jacques Parienti

given: Jean-Jacques

family: Peyro-Saint-Paul

full_name: Laure Peyro-Saint-Paul

given: Laure

full_name: G. Defer

given: G.

family: Derache

full_name: N. Derache

given: N.

family: Branger

full_name: P. Branger

given: P.

family: Casez

full_name: O. Casez

given: O.

family: Vaillant

full_name: M. Vaillant

given: M.

family: Labauge

full_name: P. Labauge

family: Magy

full_name: L. Magy

given: L.

family: Montcuquet

full_name: A. Montcuquet

given: A.

family: Castelnovo

full_name: G. Castelnovo

family: Cohen

full_name: M. Cohen

family: Bourre

full_name: B. Bourre

given: B.

family: Kwiatkowski

full_name: A. Kwiatkowski

family: De Broucker

full_name: T. De Broucker

given: T.

family: Creange

full_name: A. Creange

family: Heinzlef

full_name: O. Heinzlef

family: Wiertlewski

full_name: S. Wiertlewski

given: S.

name: the Société Francophone de la Sclérose en Plaques (SFSEP)


title: Study of Symptoms Linked to Covid-19 in Residents and Professionals in EHPAD, Associated With a Dual Diagnostic Approach by PCR and Serology: a Cohort in Île-de-France.

acronym: COVID - EHPAD

summary: The main purpose is to study the prevalence of Covid-19 in EHPAD. The primary endpoint will be the combination of PCR results and symptomatology, making it possible to define positive cases in EHPAD, in residents and professionals in contact with them. The prevalence obtained can be compared with the results of serology if these are performed.

lead_sponsor: Gérond'if


title: Descriptive Pharmacoepidemiological Study on the Use of Symbicort Turbuhaler in the Treatment of Asthma in France and Impact of a New Therapeutic Strategy on the Compliance and Control of Asthma

acronym: SYMBIOSE

summary: Descriptive pharmacoepidemiological study on the use of Symbicort Turbuhaler in the treatment of asthma in France and impact of a new therapeutic strategy on the compliance and control of asthma


title: SEEK Study - Study on Emergency Health Care Workers' Job Strain Evaluated by Karasek Questionnaire

acronym: SEEK

summary:
Emergency health care workers are exposed to job strain - defined by Karasek as a combination of high job demands and low job control. Emergency health care work is a complex interaction between stress due to life-threatening emergencies, overcrowding of the Emergency Department, the lack of sleep, bad food repartition during shifts, and accumulated fatigue. However, the Karasek questionnaire has never been assessed for Emergency Health Care workers. Furthermore, the variation of results during the career has never been assessed.

The same measures will be repeated every 5 year to assess long term changes in subjective and objective measures of stress.

The study's main objective is the creation of an Emergency Health Care worker's cohort to assess the evolution of the Karasek questionnaire during the follow-up.

Secondary objectives are

the evaluation of the food intake before, during and after a nightshift.
the evaluation of other questionnaires

ReferenceCitation: Bouillon-Minois JB, Trousselard M, Pereira B, Schmidt J, Clinchamps M, Thivel D, Ugbolue UC, Moustafa F, Occelli C, Vallet G, Dutheil F. Protocol of the Study on Emergency Health Care Workers' Responses Evaluated by Karasek Questionnaire: The SEEK-Study Protocol. Int J Environ Res Public Health. 2021 Apr 12;18(8). pii: 4068. doi: 10.3390/ijerph18084068.

family: Bouillon-Minois

full_name: Jean-Baptiste Bouillon-Minois

given: Jean-Baptiste

family: Trousselard

full_name: Marion Trousselard

given: Marion

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Schmidt

full_name: Jeannot Schmidt

given: Jeannot

family: Clinchamps

full_name: Maelys Clinchamps

given: Maelys

family: Thivel

full_name: David Thivel

given: David

family: Ugbolue

full_name: Ukadike Chris Ugbolue

given: Ukadike Chris

family: Moustafa

full_name: Farès Moustafa

given: Farès

family: Occelli

full_name: Céline Occelli

given: Céline

family: Vallet

full_name: Guillaume Vallet

given: Guillaume

family: Dutheil

full_name: Frédéric Dutheil

given: Frédéric

currency_apc_doaj: CHF

journal_name: International Journal of Environmental Research and Public Health

repository_institution: University of Strathclyde - Strathprints: The University of Strathclyde institutional repository

version: acceptedVersion

publisher: MDPI AG

publisher_dissemination: MDPI

publisher_group: MDPI

publisher_normalized: MDPI

title: Protocol of the Study on Emergency Health Care Workers’ Responses Evaluated by Karasek Questionnaire: The SEEK-Study Protocol

lead_sponsor: University Hospital, Clermont-Ferrand


title: Epidemiological Description of the Kaposi's Disease in France's Southeast

summary: The purpose of this study is to evaluate the prevalence of the Kaposi's disease in France's southeast on 10 years (from 2007 to 2017)

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Sainte-Anne


title: Study of the Interest of ECG Teletransmission in Retirement Home (EHPAD) In the Ile-de-France Region.

acronym: TEECAD

summary: The aim of the study is to evaluate the interest and the workability of ECG teletranmission in EHPAD in Île-de-France. ECG for the elderly is beneficial to detect or monitor cardiovascular disease.

location_facility: Psychiatric Geriatric Department, Broca hospital


title: Portrayal of Hospital Alcohol Detoxifications and Factors Associated With Longer or Ulterior Hospitalizations in France From 2011 to 2020

acronym: Alcostop

summary: Even if hospital alcohol detoxifications are frequent in France, their caracteristicscharacteristics remain unknown. The investigators aim to describe the clinical and paraclinical caracteristicscharacteristics of their patients, their length and geographical repartition, etc… The investigators also aim to evaluate factors associated with longer stays or ulterior re-hospitalization for the same reason. Finally, The investigators aim to compare the stays by facility type.


type: Registry Identifier

title: Prevention of HIV in "Île-de-France"

acronym: ANRS-PREVENIR

summary:
Interventional HIV prevention strategy based on pre-exposure prophylaxis (PrEP) with Truvada® for people in the Île-de-France area (or Paris region) who don't have HIV but who are at high risk of becoming infected with HIV (men who have sex with men (MSM), transgender men and women, heterosexual men and women, sex workers, migrants) in combination with overall prevention services (communautary-based or educational counselling; addiction, social and psychological care; condoms and lubricating gel; clean injection equipment; sexually transmitted diseases (STD) screening and treatment; hepatitis A virus (HAV), hepatitis B virus (HBV) and hepatitis C virus (HCV) vaccinations and post-exposure treatment of HIV infection as soon as possible after diagnosis using an antiretroviral combination recommended by the French Guidelines on HIV treatment).

The individual benefit being already demonstrated in clinical trials, the aim is to demonstrate the public health impact of the interventional HIV prevention strategy by reducing the risk of getting HIV-1 infection of at least 15% of new diagnosis of HIV infections among MSM/transgender in the Ile-de-France area after a 3-year period.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility:
Hôpital Necker-Enfants Malades
Hôpital André Mignot
Hôpital Tenon
Hôpital Henry Mondor
Hôpital Saint-Antoine
Hôpital Ambroise-Paré
Hôpital de Bicêtre
Hôpital Antoine Béclère
Hôpital Foch
Hôpital Jean Verdier
Hôpital Bichat-Claude-Bernard
Hôpital Saint-Louis
Hôpital Pitié-Salpétrière
CHI Poissy Saint Germain en Laye
Hôpital Cochin
Hôpital Avicenne
Hôpital Raymond Poincaré
Centre Hospitalier Marc Jacquet
Hôpital Louis Mourier
Hôpital Hôtel Dieu
Hôpital Européen Georges Pompidou

intervention_type: Drug


title: Hepatitis E Infection : Emergence Mechanisms in North-Eastern France of Polymorphic Clinical Forms.

acronym: VHENE

summary: The present research aims to collect virological and clinical data on hepatitis E virus (HEV) infections, either in acute or chronic forms of HEV infection in North-Eastern France, with liver- or non liver-related symptoms, plus data on HEV circulation in the outside environment. The purpose of this study is to improve the diagnosis and care of HEV-infected patients, as well as the preventive features to take into account in order to avoid food- and environment-borne infections. At last, we will investigate HEV molecular characteristics, with the hypothesis that some advantageous HEV strains coul be more pathogenic for some tissues and/or organs.

lead_sponsor: Central Hospital, Nancy, France


title: Evaluation of Covid-19 Vaccination in Elderly Subjects in Retirement Home (EHPAD) and Long-term Care Units (USLD) in Ile-de-France

acronym: COGEVAX

summary:
The main objective of this non-interventional, multi-center study is to compare the incidence of serious health events (death, unscheduled hospitalizations) in subjects vaccinated against Coronavirus with that of unvaccinated subjects, in Retirement Home (EHPAD) and Long-term Care Units (USLD) in Ile-De-France during the same 12-month observation period.

The primary outcome will be the incidence of serious health events (death and unscheduled hospitalizations) in subjects vaccinated against Coronavirus compared to that of unvaccinated subjects.


title: National Lymphangioleiomyomatosis Registry, France

acronym: RE-LAM-CE

summary:
RE-LAM-CE is a registry of lymphangioleiomyomatosis cases in France. its aim is to determine the incidence and prevalence of lymphangioleiomyomatosis in France, including demographic information and information concerning the timing and modalities of diagnosis.

Based on the registry, we will set up a prospective cohort of patients. The database will include detailed medical information, particularly regarding progression of the respiratory function.

lead_sponsor: Vincent COTTIN


title: Observational Study on the Use of Xydalba: A Multicenter, Prospective Study to Characterize the Use of Xydalba in France

summary:
This observational study will collect data on the use of the drug Xydalba® in daily clinical practice in France. Such observational studies are also referred to as registries. The sponsor of the study is Correvio International Sárl, based in Switzerland.

Xydalba® contains the active substance dalbavancin, a remedy for a certain type of bacterial pathogens (so-called "gram positive bacteria") which cause the disease. Active ingredients against bacteria are also called antibiotics.

Correvio wants to know which patients received the drug and how the disease went. The treatment places where you got Xydalba, ie clinic, intensive care unit or elsewhere should be recorded. In addition, it is important in this type of medication to track whether the pathogens are changing in any way. Any safety-relevant events (such as side effects) that have occurred during treatment should be investigated by the sponsor and submitted to the competent European authorities.

lead_sponsor: Correvio International Sarl

location_facility: CHU GRENOBLE, Maladies infectieuses et tropicales

location_facility: Centre hospitalier universitaire de Nice

location_facility: Centre Hospitalier de Tourcoing,Service des Maladies Infectieuses et du Voyageur

location_facility: Centre Hospitalier Universitaire de Nîmes (CHU)

location_facility: Hôpital de la Croix-Rousse, Service des maladies infectieuses et tropicales

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Saint-André

location_facility: Pontchaillou University Hospital, Infectious Diseases and Intensive Care Unit

location_facility: Centre hospitalier d'Ajaccio, Maladies infectieuses et tropicales

location_facility: Centre hospitalier régional et universitaire de Nancy


title: Multicenter, Non-interventional Study, Describing Patients With Inherited Retinal Disease (IRD) in France

acronym: EPI-genRET

summary:
Genetic diagnostic testing becomes increasingly important for enhancing our understanding of the disease notably the genetics and providing the best care to the patients, and several initiatives seek to gather more data in order to better understand and treat those diseases.

Within this context, Novartis and SENSGENE/Strasbourg University Hospitals (HUS) want to set up, through a research collaboration, a non-interventional study in France to better understand the epidemiology of IRDs, particularly the distribution of pathogenic variants in patients. This study aims to serve as a starter study to implement an IRD national registry led by SENSGENE/Strasbourg University Hospitals (HUS). The data collected might also be used to populate global European registries. The primary objective has been defined in a sufficient broad way to address this perspective of registries.

As IRDs can present from birth to late middle age, this study will include both children and adult patients regardless of age, sex, and the type of IRD.

lead_sponsor: University Hospital, Strasbourg, France


title: Puumala Hantavirus Infection in France: Evaluation of Commercial Assays for the Detection of Antibodies Against This Virus and the Use of Urine Samples for the Molecular Detection of This Infection

acronym: HANTADIAG

summary: Routine Puumala virus (PUUV) infection diagnosis is performed using serological commercial kits of which performances have not been established in real life, which use recombinant protein from strains from Central or North Europe. Molecular diagnostic of these infection is not the rule. Consequently the objectives of the project are to evaluate the performances of the serological commercial assays in real life in France and to assess the use of urine versus plasma for the molecular diagnostic of this infection.

ReferenceCitation: Plyusnin A, Hörling J, Kanerva M, Mustonen J, Cheng Y, Partanen J, Vapalahti O, Kukkonen SK, Niemimaa J, Henttonen H, Niklasson B, Lundkvist A, Vaheri A. Puumala hantavirus genome in patients with nephropathia epidemica: correlation of PCR positivity with HLA haplotype and link to viral sequences in local rodents. J Clin Microbiol. 1997 May;35(5):1090-6.

ReferenceCitation: Prince HE, Lieberman JM. Impact of the Yosemite hantavirus outbreak on hantavirus antibody testing at a national reference laboratory. Clin Vaccine Immunol. 2013 Aug;20(8):1213-6. doi: 10.1128/CVI.00326-13. Epub 2013 Jun 5.

ReferenceCitation: Lederer S, Lattwein E, Hanke M, Sonnenberg K, Stoecker W, Lundkvist Å, Vaheri A, Vapalahti O, Chan PK, Feldmann H, Dick D, Schmidt-Chanasit J, Padula P, Vial PA, Panculescu-Gatej R, Ceianu C, Heyman P, Avšič-Županc T, Niedrig M. Indirect immunofluorescence assay for the simultaneous detection of antibodies against clinically important old and new world hantaviruses. PLoS Negl Trop Dis. 2013 Apr 4;7(4):e2157. doi: 10.1371/journal.pntd.0002157. Print 2013. Erratum in: PLoS Negl Trop Dis. 2020 Nov 9;14(11):e0008864.

ReferenceCitation: Hentzien M, Mestrallet S, Halin P, Pannet LA, Lebrun D, Dramé M, Bani-Sadr F, Galempoix JM, Strady C, Reynes JM, Penalba C, Servettaz A. Bioclinical Test to Predict Nephropathia Epidemica Severity at Hospital Admission. Emerg Infect Dis. 2018 Jun;24(6):1045-1054. doi: 10.3201/eid2406.172160.

lead_sponsor: Centre Hospitalier de Charleville-Mézières

location_facility:
CH de Laon
CHU Reims
CH de Saint Claude
CH Charleville Mézières
CHU Dijon
CHU Besançon
CH de Verdun
CHU Nancy
CH Belfort-Montbéliard
CHP Sud de l'Oise


title: Follow-up of Heart Failure Patients With an Implantable Cardiac Defibrillator Enabled With the HeartLogic Algorithm - HeartLogic France Study

summary:
Heart Failure (HF) is a chronic disease that leads to numerous rehospitalisations and affects more than one million people in France.

The main objective of this prospective multicentric French study is to describe the annual rate of unplanned hospitalisations for heart failure in a cohort of patients managed by a HeartLogic algorithm.

Patients will be included if they fulfill the following requirements 1/Patient implanted with a cardiac defibrillator with or without resynchronisation with the HeartLogic index (RESONATE family, Boston Scientific); 2/History of heart failure (left ventricular ejection fraction ≤40 %; or at least one episode of clinical heart failure with elevated NT pro BNP≥450 ng/L)

If a HeartLogic index ≥16 is noticed, the investigator will contact the patient to assess the patient's clinical condition and possibly adjust the heart failure treatment.

lead_sponsor: Poitiers University Hospital

location_facility:
Hopital Europeen G Pompidou
University hospital of Brest
Clinique du Confluent
Clinique Pasteur
Hospital of Lorient

intervention_type: Diagnostic Test


title: Impact of Containment and Quarantine During COVID-19 Outbreack on Psychotic Symptoms in the General Population in France

summary: Study the impact of containment related to COVID-19 pandemic on psychotic experiences in the general population in France.

lead_sponsor: University Hospital, Montpellier


summary: The aim is to document viral etiologies of isolated fevers and inlfuenza-like syndromes during summertime in South of France in order to better understand the role of known vector-borne viruses such as Toscana virus, West Nile virus during seasonal activity of the arthropod vector. In each of the four cities, a network of general practitioners will be associated in the project to recruit patients who are not hospitalized. The combined involvement of infectious disease specialists and general practitioner will augment the range of patients (mild disease and sever cases) in the study.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Service des Maladies Infectieuses et Tropicales de l'Hôpital Nord, AP-HM


title: Impact of HPV Vaccination on the Distribution of HPV in High Grade Lesions of the Cervix in France

acronym: IMPACT

summary: The objective is to estimate the prevalence of the different genotypes of human papillomaviruses (HPV) in histologically proven high-grade lesions of the cervix in patients born between 1972 and 1993. It is plan to determine if the prevalence of HPV16 and HPV18 is lower in the population born between 1983 and 1993 and potentially exposed to HPV vaccination compared to those born between 1972 and 1982 who were not exposed to vaccination. Thus the investigators should be able to determine whether the introduction of HPV vaccination in France in 2007 has had an impact on the development of high-grade lesions associated with HPV16 and HPV18.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: HCV Care Pathway in Ile-de-France

acronym: ParcoursVHC

summary: The main objective of this research is to evaluate a care pathway adapted to different category populations at risk of being infected with the hepatitis C virus in order to improve both the diagnosis turnaround times and the access to treatment. The aim is to allow a quick and effective access to diagnosis and treatment of HCV by strengthening the city hospital networks, access to early consultations and coordination of medical social actors.


title: A Multi-centre, Prospective, Noninterventional Study Investigating the Effectiveness of Once-weekly Subcutaneous Semaglutide in a Real World Adult Population With Type 2 Diabetes

acronym: SURE FRANCE

summary: The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by their study doctor. The study will last for about 6 to 8 months. The participants will be asked to complete some questionnaires about their health and their diabetes treatment. Participants will complete these during their normally scheduled visits with their study doctor.

ipd_sharing: Yes

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S


title: Myocardial Infarction Rates Overview During COVID-19 Pandemic In France: MODIF Study

acronym: MODIF

summary: In late December 2019, an emerging disease due to a novel coronavirus (named SARS-CoV-2) rapidly spread in China and outside. France is currently facing the COVID-19 wave with more than 131 863 confirmed cases and almost 25 201 deaths. Systems of care have been reorganized in an effort to preserve hospital bed capacity, resources, and avoid exposure of patients to the hospital environment where COVID-19 may be more prevalent. Therefore, elective procedures of catheterization and programmed hospitalizations have been delayed. However, a significant proportion of procedures within the catheterization laboratory such as ST-elevation myocardial infarction (STEMI), non ST elevation myocardial infarction or unstable angina are mandatory and cannot be postponed. Surprisingly, invasive cardiologist noticed a drop in STEMI volume without reliable data to confirm this impression. Furthermore, a recent single center report in Hong Kong pointed out longer delays of taking care when compared to patients with STEMI treated with percutaneous intervention the previous year. These data are at major concern because delay in seeking care or not seeking care could have detrimental impact on outcomes.

lead_sponsor: French Cardiology Society


title: BIO|STREAM.ICM France, Submodule of the BIO|STREAM.ICM Registry

summary: The main objective of the BIO│STREAM.ICM France submodule is to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR system

lead_sponsor: Biotronik SE & Co. KG

location_facility:
Hôpital Gabriel Montpied
CHRU de Tours, Hopital Trousseau
CH Villefranche Sur Saone


title: Gastroprotective Agent Utilization and Compliance in Elderly Patients Taking Non-steroidal Anti-inflammatory Drug (NSAID) in France

summary: The purpose of this study is to assess in general population NSAID and gastroprotective agent utilization and compliance in elderly people.

lead_sponsor: AstraZeneca


title: Long Term Follow up of Patients Under 5 Years of Age With High Grade Glioma Diagnosed in France Between 1990 and 2015

summary: High grade glioma is a rare disorder affecting children at all ages with a high mortality rate. Overall survival is estimated at 40%, depending on the type of treatment administered. Major late sequelaes are experienced with the irradiation in this population under 5 years. Therefore, the current recommendations by The French Society for Childhood Cancers are based on a treatment including surgery followed by chemotherapy and avoiding radiotherapy as long as patients present no sign of treatment failure. The results published in 2006, underlying the fact that some patients treated exclusively with surgical resection and chemotherapy can achieve long term survival, are showing evidence of an acceptable long-term strategy. Few studies concerning evaluation of treatment toxicity and long term outcomes are available. Therefore, it is important to collect retrospective data concerning those small patients with high grade glioma in order to understand the reasons of treatment success or failure and treatment toxicities. This retrospective study will evaluate long term survivals comparatively to clinical, radiological and histological features at diagnosis and the treatment toxicities including neurological, endocrine and hearing impairment to go further and propose new potential guidelines and chemotherapy schedules


title: Use of Methylphenidate in Children and Adolescents in France

summary: The use of methylphenidate in children and adolescents in France from 2010 to 2015

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Connection Between GP's Estimation of Cardiovascular Risk and Theoretical Calculation in France

summary: The purpose of this study is to evaluate connection between GP's estimation of cardiovascular risk and theoretical calculation.


title: C.O.R.P.U.S. : Observational Cohort of Active Rheumatoid Arthritis, Spondylarthropathy and Idiopathic Juvenile Arthritis in France

summary:
C.O.R.P.U.S. is the first French observatory of care practices in active inflammatory rheumatism of children and adults: rheumatoid arthritis, spondylarthropathy, and idiopathic juvenile arthritis, established under the auspices of national health authorities.

Its goal is to document safety, effectiveness in routine practice of various therapy, including biotherapy, of prescription or non-prescription over 5 years.

A cohort will be constituted including any new case of active disease (DAS 28 > 3,2, BASDAI > 4, failure of methotrexate), without previous prescription of biotherapy. Therefore, it will be possible to have patients non exposed to biotherapy (non indication, refusal, contraindication) compared to patients exposed to biotherapy, and to monitor adverse events occurrence as well as effectiveness in routine practice over time, according to prescription, maintenance or switch of various therapies.

ipd_sharing_description: open to partnership


title: Evaluation of Vitamin D Deficiency Distribution in Children With Sickle Cell Disease Followed in Lyon, France

acronym: EVADDREP

summary: Vitamin D deficiency may be under-diagnosed in sickle cell disease French children. Therefore, the investigator need an epidemiologic study about the prevalence of vitamin D deficiency in this specific population. There are not specific guidelines neither testing nor treatment. The investigator propose to test vitamin D status in all children with sickle cell disease who are consulting their referring haematologist doctor or in the emergency ward.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Femme Mère enfant - Urgences pédiatriques

intervention_type: Biological


title: Outpatient Use of Analgesics in Children and Adolescents in France

summary: outpatient use of analgesics in children and adolescents in France from 2012 to 2015


title: FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France: the FEERIC Study

acronym: FEERIC

summary: FErtility, PrEgnancy, contRaceptIon after breast Cancer in France

lead_sponsor: Institut Curie