title: Test of Ventricular Stimulation as Immediate Predictor of Hypovolemia After Cardiac Surgery: Non-randomized Open Label Trial.

acronym: TESTI

summary: The purpose of the study is to validate a ventricular pacing test as a predictor of preload dependency in post cardiac surgery patients.

intervention_type: Diagnostic Test


title: Effect of Opioid-free Anesthesia on Perioperative Period After Video-assisted Thoracoscopic Lobectomy: a Retrospective Study

acronym: VATOFA

summary:
No study has been conducted to demonstrate the feasibility and safety of an Opioid-Free Anesthesia (OFA) protocol compared to Opioid-Based Anesthesia (OBA) in thoracic surgery, at risk for intense post-operative pain, to improve patient care. The aim of the present study was to evaluate the effect of OFA on post-operative opioids consumption, pain and the post-operative period after lobectomy by Video-Assisted Thoracoscopy Surgery (VATS). systems.

Investigators perform a retrospective, single-center study in 2019. Patients were divided into two groups: OFA (with dexmedetomidine) or OBA (sufentanyl).

Investigators analyse the total postoperative opioid consumption in the 48 h after surgery. Investigators asses pain intensity in the 48 h after surgery, operative hemodynamic stability, Post-Operative Pain (POP) in Post-Anesthesia Care Unit (PACU) and POP on day 30.

All data are available in the medical record

Hypothesis: OFA can reduce post-operative opioids consumption, pain in lobectomy by video-assisted thoracoscopy surgery (VATS).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of Anesthesiology and Intensive Care - Louis Pradel University Hospital - Hospices Civils, Lyon, France

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers

acronym: Pre-QuantiPark

summary: Pre-QuantiPark is a pilot study to evaluate the reliability and responsiveness of ActiMyo measured activity in PD patients. The purpose of the study is to provide validation of the ActiMyo, an innovative home-recording device enabling use in clinical trials and as an innovative tool for PD patient care.

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Institut de Myologie, France

location_facility: Service de Neurochirurgie, Hopital Henri Mondor

location_facility: Département des Maladies du Système Nerveux, GH Pitie Salpatriere

lead_sponsor_type: industriel


type: Other Identifier

title: Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA in the Administered Rt-PA

acronym: OPHELIE

summary: intravenous rt-PA is effective to reduce the risk of death or dependency after ischaemic stroke. This effect is due to an early recanalization secondary to the lysis of the clot. However this effect may be counterbalanced by the increased risk of bleeding and also the neurotoxicity of rt-PA, which has been shown in animals to depend on the ratio single chain (sc) / double chain (tc) in the rt-PA administered. The main objective of OPHELIE is to determine whether the functional outcome after treatment by iv rt-PA depends on the ratio sc-rtPA / tc-rtPA. Secondary objectives were to identify the influence on the risk of brain haemorrhage, and the influence of the cognitive state (OPHELIE-COG substudy).

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Caparros F, Kuchcinski G, Drelon A, Casolla B, Moulin S, Dequatre-Ponchelle N, Henon H, Cordonnier C, Pruvo JP, Leys D. Use of MRI to predict symptomatic haemorrhagic transformation after thrombolysis for cerebral ischaemia. J Neurol Neurosurg Psychiatry. 2020 Apr;91(4):402-410. doi: 10.1136/jnnp-2019-321904. Epub 2020 Feb 3.

family: Caparros

full_name: François Caparros

given: François

sequence: first

family: Kuchcinski

full_name: Gregory Kuchcinski

given: Gregory

sequence: additional

family: Drelon

full_name: Agathe Drelon

given: Agathe

family: Casolla

full_name: Barbara Casolla

given: Barbara

family: Moulin

full_name: Solene Moulin

given: Solene

family: Dequatre-Ponchelle

full_name: Nelly Dequatre-Ponchelle

given: Nelly

family: Henon

full_name: Hilde Henon

given: Hilde

family: Cordonnier

full_name: Charlotte Cordonnier

given: Charlotte

family: Pruvo

full_name: Jean-Pierre Pruvo

given: Jean-Pierre

family: Leys

full_name: Didier Leys

given: Didier

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Leys D, Hommet Y, Jacquet C, Moulin S, Sibon I, Mas JL, Moulin T, Giroud M, Sagnier S, Cordonnier C, Medeiros de Bustos E, Turc G, Ronzière T, Bejot Y, Detante O, Ouk T, Mendyk AM, Favrole P, Zuber M, Triquenot-Bagan A, Ozkul-Wermester O, Montoro FM, Lamy C, Faivre A, Lebouvier L, Potey C, Poli M, Hénon H, Renou P, Dequatre-Ponchelle N, Bodenant M, Debruxelles S, Rossi C, Bordet R, Vivien D; OPHELIE investigators and the STROKAVENIR network. Proportion of single-chain recombinant tissue plasminogen activator and outcome after stroke. Neurology. 2016 Dec 6;87(23):2416-2426. Epub 2016 Nov 4.

lead_sponsor: University Hospital, Lille


title: French Long Term Registry With Longitudinal Follow up of PDGFRA D842V-GIST Patients Treated With Avapritinib : AVapritinib Real-life observatTORy

summary:
GIST are rare mesenchymal tumors of the gastrointestinal tract characterized by somatic mutations in the gene encoding the KIT (85%) or the PDGFRα (8%) protein. Treatment of localized forms relies on adequate surgery without tumor spillage and sometimes systemic treatment with imatinib according to risk of relapse defined by localization, tumor size and mitotic count, as well as mutational status. More than 40% of cases may recur and metastasize. Advanced and relapsing forms are currently treated with oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR such as imatinib (standard treatment), sunitinib (2nd line) and regorafenib (3rd line). Nevertheless, imatinib has little or no activity in patients harboring the D842V mutation in the exon 18 of PDGFRα (20% of gastric GIST, 6% of all GIST patients). Consequently, other therapeutic alternatives are needed.

Results from the phase I single-arm NAVIGATOR study show that avapritinib has significant efficacy in GIST patients with PDGFRα D842V mutation (ORR = 86 %). In France, an authorization for temporary use (ATUc) starting on September 21st, 2020 has been granted by the National Agency for Safety of Medicines and Health Products (ANSM). It allows the early availability of avapritinib in France while waiting for Market Authorization Approval (AMM). This ATUc will be accompanied by a protocol of therapeutic use and collection of information (PUT) that describes the frequency of patient visits.

The objective of this real-life registry is to perform a long-term longitudinal follow up of PDGFRA D842V-mutated GIST patients treated with avapritinib and to collect effectiveness and safety data. It will be implemented in parallel to the ATUc until June 2023.

Data from the electronic health record (EHR) will be collected. Moreover, as per the ANSM's requirements, quality of life and cognitive function will be investigated using FACT-G, FACT-Cog and MoCA questionnaires.

Undesirable effects will be collected as well. Follow-up is envisioned for a minimum of 2 years.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Centre Leon Berard

location_facility:
Centre Léon Bérard
CHU Robert Debré
CHRU Besançon
Insitut Bergonié
Institut Gustave Roussy
Centre Geroges François Leclerc

intervention_type: Drug

status_simplified: Ongoing


type: Registry Identifier

title: Clinical Characterisation Protocol for Severe Emerging Infections

acronym: FrenchCOVID

summary:
Infectious disease is the single biggest cause of death worldwide. New infectious agents, such as the SARS, MERS and other novel coronavirus, novel influenza viruses, viruses causing viral haemorrhagic fever (e.g. Ebola), and viruses that affect the central nervous system (CNS) such as TBEV & Nipah require investigation to understand pathogen biology and pathogenesis in the host. Even for known infections, resistance to antimicrobial therapies is widespread, and treatments to control potentially deleterious host responses are lacking.

In order to develop a mechanistic understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed, it is necessary to understand pathogen characteristics associated with virulence, the replication dynamics and in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of antimicrobial or host-directed therapies, the transmission dynamics, and factors underlying individual susceptibility.

The work proposed here may require sampling that will not immediately benefit the participants. It may also require analysis of the host genome, which may reveal other information about disease susceptibility or other aspects of health status.

ReferenceCitation: Gault N, Esposito-Farèse M, Revest M, Inamo J, Cabié A, Polard É, Hulot JS, Ghosn J, Chirouze C, Deconinck L, Diehl JL, Poissy J, Epaulard O, Lefèvre B, Piroth L, De Montmollin E, Oziol E, Etienne M, Laouénan C, Rossignol P, Costagliola D, Vidal-Petiot E; French-Covid cohort investigators, study group. Chronic use of renin-angiotensin-aldosterone system blockers and mortality in COVID-19: A multicenter prospective cohort and literature review. Fundam Clin Pharmacol. 2021 Dec;35(6):1141-1158. doi: 10.1111/fcp.12683. Epub 2021 May 16.

name: Centre d’Investigations cliniques‐Epidémiologie Clinique 1425 INSERM Hôpital Bichat Paris75018France

name: Département Epidémiologie Biostatistiques et Recherche Clinique AP‐HP Hôpital Bichat Paris75018France

family: Gault

full_name: Nathalie Gault

given: Nathalie

name: URC Paris Nord AP‐HP DRCI Hôpital Bichat Paris75018France

family: Esposito‐Farèse

full_name: Marina Esposito‐Farèse

given: Marina

name: Service des Maladies Infectieuses et Réanimation Médicale Univ Rennes INSERM UMR 1230 Bacterial Regulatory RNA and Medicine CHU Rennes Rennes France

family: Revest

full_name: Matthieu Revest

given: Matthieu

name: Département de Cardiologie EA7525 CHU Martinique Fort‐de‐France France

family: Inamo

full_name: Jocelyn Inamo

given: Jocelyn

name: Inserm CIC 1424 Université des Antilles EA 7524 Service de maladies infectieuses et tropicales CHU de Martinique Fort‐de‐France France

family: Cabié

full_name: André Cabié

given: André

name: Department of Clinical Pharmacology Pharmacovigilance, Pharmacoepidemiology and Drug Information Centre Rennes University Hospital Rennes France

family: Polard

full_name: Élisabeth Polard

given: Élisabeth

name: PARCC INSERMUniversité de Paris Paris75015France

name: INSERM Centre d’Investigations cliniques‐plurithématique 1418 and DMU CARTE F‐CRIN INI‐CRCT network AP‐HP Hôpital Européen Georges‐Pompidou Paris751015France

family: Hulot

full_name: Jean‐Sébastien Hulot

given: Jean‐Sébastien

name: Service de Maladie Infectieuses et Tropicales AP‐HP Hôpital Bichat Paris France

family: Ghosn

full_name: Jade Ghosn

given: Jade

name: Service de Maladie Infectieuses et Tropicales CHU Besançon Besançon France

family: Chirouze

full_name: Catherine Chirouze

given: Catherine

family: Deconinck

full_name: Laurène Deconinck

given: Laurène

name: Service de Médecine Intensive Réanimation Laboratoire de Recherche Biochirurgicale (Fondation Carpentier) AP‐HP Hôpital Européen Georges‐Pompidou Paris France

name: UMR_S 1140 Innovations thérapeutiques en Hémostase Université de ParisINSERM Paris France

family: Diehl

full_name: Jean‐Luc Diehl

given: Jean‐Luc

name: Inserm U1285 CHU Lille, Pôle de réanimation UMR 8576 ‐ UGSF ‐ Unité de Glycobiologie Structurale et Fonctionnelle Université de LilleCNRS Lille France

family: Poissy

full_name: Julien Poissy

given: Julien

name: Service de Maladies Infectieuses et Médecine Tropicale CHU Grenoble Rhône Alpes Grenoble France

family: Epaulard

full_name: Olivier Epaulard

given: Olivier

name: Service des Maladies Infectieuses et Tropicales CHRU NancyUniversité de Lorraine Nancy France

name: APEMAC Université de Lorraine Nancy France

family: Lefèvre

full_name: Benjamin Lefèvre

given: Benjamin

name: Département d’infectiologie Université de BourgogneCHU Dijon Bourgogne Dijon France

family: Piroth

full_name: Lionel Piroth

given: Lionel

name: Service de réanimation médicale et des maladies infectieuses AP‐HP Hôpital Bichat Paris France

name: IAME UMR 1137 INSERMUniversité de Paris Paris France

family: De Montmollin

full_name: Etienne De Montmollin

given: Etienne

name: Service de Médecine Hospitalière CHU Beziers Beziers France

family: Oziol

full_name: Eric Oziol

given: Eric

name: Service des Maladies Infectieuses et Tropicales CHU Rouen Rouen France

family: Etienne

full_name: Manuel Etienne

given: Manuel

family: Laouénan

full_name: Cédric Laouénan

given: Cédric

name: Centre d’Investigations cliniques‐plurithématique 1433 INSERM U1116 CHRU NancyUniversité de LorraineINSERM Nancy France

family: Rossignol

full_name: Patrick Rossignol

given: Patrick

name: Institut Pierre Louis d’Épidémiologie et de Santé Publique (IPLESP) Sorbonne UniversitéINSERM Paris France

family: Costagliola

full_name: Dominique Costagliola

given: Dominique

name: Service de Physiologie rénale AP‐HP Hôpital Bichat Paris France

name: U1149 INSERMUniversité de Paris Paris France

family: Vidal‐Petiot

full_name: Emmanuelle Vidal‐Petiot

given: Emmanuelle

family: Bartoli

full_name: Marie Bartoli

given: Marie

name: the French‐Covid cohort investigators, study group

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

title: Chronic use of renin‐angiotensin‐aldosterone system blockers and mortality in COVID‐19: A multicenter prospective cohort and literature review

ReferenceCitation: Buetti N, Wicky PH, Le Hingrat Q, Ruckly S, Mazzuchelli T, Loiodice A, Trimboli P, Forni Ogna V, de Montmollin E, Bernasconi E, Visseaux B, Timsit JF. SARS-CoV-2 detection in the lower respiratory tract of invasively ventilated ARDS patients. Crit Care. 2020 Oct 16;24(1):610. doi: 10.1186/s13054-020-03323-5.

ReferenceCitation: Bouadma L, Wiedemann A, Patrier J, Surénaud M, Wicky PH, Foucat E, Diehl JL, Hejblum BP, Sinnah F, de Montmollin E, Lacabaratz C, Thiébaut R, Timsit JF, Lévy Y. Immune Alterations in a Patient with SARS-CoV-2-Related Acute Respiratory Distress Syndrome. J Clin Immunol. 2020 Nov;40(8):1082-1092. doi: 10.1007/s10875-020-00839-x. Epub 2020 Aug 22.

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

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

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

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

location_facility: Grand Hopital de l'Est Francilien site Marne-la-Vallée

location_facility: Assistance publique hopitaux de Marseille, hopital Nord

location_facility: Hopital d'instruction des armées Begin 69

location_facility: Centre Hospitalier Régional Universitaire de Tours

location_facility: CHU Toulouse IUCT Institut Universitaire de Cancer de Toulouse

location_facility: Centre Hospitalier Universitaire de Rangueil

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Centre hospitalier Louis Constant Fleming

location_facility: Centre hospitalier Intercommunal de Créteil

location_facility: Centre Hospitalier Universitaire de Lille


title: A Randomized, Double-Blind, Phase 3 Study of Momelotinib vs Danazol in Symptomatic, Anemic Subjects With Previously JAKi Treated Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis

summary:
MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic subjects who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, UK, and US.

Subjects must be symptomatic with a MFSAF v4.0 Total Symptom Score of ≥ 10 at screening, and be anemic with Hgb < 10 g/dL. For subjects with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization.

Subjects will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Subjects randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the subject tolerates and continues to benefit from MMB.

Subjects randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances:

at the end of Week 24 if they complete the randomized treatment period; or
at the end of Week 24 if they discontinue treatment with DAN but continue study assessments and do not receive prohibited medications including alternative active anti-MF therapy; or
at any time during the randomized treatment period if they meet the protocol-defined criteria for radiographically-confirmed symptomatic splenic progression.

Subjects randomized to receive DAN who are receiving clinical benefit at the end of Week 24 may choose to continue DAN therapy up to Week 48. The comparator treatment, DAN, is an approved medication in the US and in some other countries and is recommended by national guidelines as a treatment for anemia in MF.

status: Active, not recruiting

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Sierra Oncology, Inc.

location_country:
Romania
Australia
Belgium
Denmark
Taiwan
France
Poland
Canada
Korea, Republic of
Sweden
Bulgaria
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Czechia
Israel
New Zealand
Spain

location_facility: Research Institute of the McGill University Health Centre

location_facility: Ospedale Policlinico Giambattista Rossi Borgo Roma

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: University Multiprofile Hospital For Active Treatment Aleksandrovska

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Northwest Oncology & Hematology - Rolling Meadows

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

location_facility: American Institute of Research - Whittier

location_facility: Presidio Ospedaliero Universitario Santa Maria della Misericordia

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: The Catholic University of Korea Seoul Saint Mary's Hospital

location_facility: Laboratul clinic MedLife-Policlinica de Diagnostic Rapid Brasov

location_facility: Centre Hosptitalier Universitaire Angers

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Alvamed Zakład Specjalistycznej Opieki Zdrowotnej

location_facility: Centre Hospitalier Universitaire Amiens-Picardie - Site Sud

location_facility: Centre Hospitalier Universitaire Nantes - Hôtel Dieu

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitario Central de Asturias

location_facility: Queen Elizabeth II Health Sciences Centre - Halifax Infirmary

location_facility: University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: Institut Hospital del Mar d'Investigacions Mèdiques

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Columbia University Irving Medical Center - Presbyterian Hospital

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Seoul National University Bundang Hospital

location_facility: Complejo Asistencial Universitario de Salamanca - Hospital Clínico

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata

location_facility: Spitalul Clinic Judetean De Urgenta Târgu Mureș

location_facility: Perth Radiological Clinic - Magnetic Resonance Centre

location_facility: Hospital Center University Of Caen Normandie

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet - Szent László Telephely

location_facility: Washington University School of Medicine in Saint Louis

location_facility: Sjællands Universitetshospital - Roskilde

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: Klinika Hematologii Nowotworów Krwi i Transplantacji Szpiku

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Alessandria

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo

location_facility: Markusovszky Egyetemi Oktatókórház Szombathely

location_facility: Guy's and Saint Thomas' NHS Foundation Trust

location_facility: Uniwersyteckie Centrum Kliniczne w Gdańsku

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: University of Colorado Hospital Anschutz Cancer Pavilion

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: University Hospitals Cleveland Medical Center

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

location_facility: Cleveland Clinic - Richard E. Jacobs Health Center

location_facility: National Specialized Hospital for Active Treatment of Haematologic Diseases


title: Observational Study of Iron Metabolism in Anemia in ICU and Post-Operative Patients, Role of Hepcidin

acronym: FAIRe

summary: Anemia in intensive care and post-operative patients is due to both blood loss (leading to iron loss) and inflammation.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Host Responses in Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection

summary: Hepatitis E is a worldwide disease. It is the leading or second leading cause of acute hepatitis in adults in developing countries from sub-Saharan Africa or Southeast Asia, where it is hyperendemic and principally water-borne. In industrialised western countries, hepatitis E was until recently considered as imported from hyperendemic geographical areas, but is currently an emerging autochthonous infectious disease. A growing body of data from Europe, America, Australia, and Asia strongly indicate that pigs represent a major Hepatitis E Virus (HEV) reservoir and might be a source of zoonotic transmission to humans through direct or indirect exposure. Hepatitis E typically causes self-limited acute infection. However, the overall death rate is 1-4%, and it can reach 20% in pregnant women and might be still higher in patients with underlying chronic liver disease. To date, no preventive or curative treatment of hepatitis E is available.

ReferenceCitation: Moal V, Textoris J, Ben Amara A, Mehraj V, Berland Y, Colson P, Mege JL. Chronic hepatitis E virus infection is specifically associated with an interferon-related transcriptional program. J Infect Dis. 2013 Jan 1;207(1):125-32. doi: 10.1093/infdis/jis632. Epub 2012 Oct 16.

family: Moal

full_name: Valérie Moal

given: Valérie

family: Textoris

full_name: Julien Textoris

family: Ben Amara

full_name: Amira Ben Amara

given: Amira

family: Mehraj

full_name: Vikram Mehraj

given: Vikram

family: Berland

full_name: Yvon Berland

given: Yvon

family: Colson

full_name: Philippe Colson

given: Philippe

family: Mege

full_name: Jean-Louis Mege

given: Jean-Louis

journal_name: The Journal of Infectious Diseases

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Chronic Hepatitis E Virus Infection Is Specifically Associated With an Interferon-Related Transcriptional Program

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Study of Geriatric Patients Aged 75 Years or Older Treated and Cured for Localized Prostate Cancer: Case-control Study

acronym: PROGE

summary:
This is a multicenter pilot study, proposed for cases and controls 3 departments in France.

Cases are cured patients who have had prostate cancer for at least 10 years. Cookies are healthy subjects selected by lottery on voter list.

Volunteer subjects (cases and controls) are offered a consultation and assessment with an geriatrician.

primary_purpose: Diagnostic

lead_sponsor: Centre Francois Baclesse

location_facility:
CHIC
CHRU
Clinique Claude BERNARD
Hopitaux universitaires de Strasbourg
Centre François BACLESSE


title: Study of the Coronary Microcirculation After Primary Angioplasty : Analysis of Absolute Coronary Blood Flow Rates and Resistance, Index of Microcirculatory Resistance and Comparison With Magnetic Resonance Imaging

acronym: NATHANAEL

summary:
In the management of acute myocardial infarction treated with primary angioplasty, despite effective epicardial clearance obtained in 95% of cases, microvascular obstruction (MVO) in the damaged territory concerns 50% of patients. The Index of Microvascular Resistance (IMR) allows early assessment of the microcirculatory state during the angioplasty procedure. A value of IMR>40 indicates MVO and is correlated with morbi-mortality. A new method for immediate evaluation of MVO using thermodilution with a new Rayflow® microcatheter has been described: it no longer allows the estimation but the measurements of absolute coronary resistance and coronary flow. We hypothesize that these measurements allows a better evaluation of the microcirculatory state after primary angioplasty, comparing to IMR.

The main objective is to study the diagnostic performance of Rayflow® to predict MVO - no reflow (NR) - in ST-Elevation Myocardial Infarction (STEMI) patients in order to determine an absolute coronary resistance threshold by thermodilution for early diagnosis of MVO.

The main secondary objectives will be to compare the different microcirculatory assessment parameters with each other, not indexed and indexed to the myocardial mass at risk (coronary resistance, IMR, CFR, Resistance Reserve Ratio) and to establish a link between high resistance or IMR and the occurrence of rhythm disorders at D1, D2 and D3.

location_facility: APHP, Lariboisière Hospital, Cardiology Department


title: Patient Empowerment for Major Surgery Preparation @ Home: Multimodal Prehabilitation in Major Elective Surgery

acronym: Paprika

summary: Non-randomized monocentric open cohort study vs historical comparative group testing the efficacy of a multimodal prehabilitation program (based on physical activity, nutritional support and mental preparation) for unfit patients based on nutrition, physical activity and mental preparation in reducing postoperative complications in elective major surgery

primary_purpose: Prevention

ReferenceType: result

ReferenceCitation: Barberan-Garcia A, Ubré M, Roca J, Lacy AM, Burgos F, Risco R, Momblán D, Balust J, Blanco I, Martínez-Pallí G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.

family: Barberan-Garcia

full_name: Anael Barberan-Garcia

given: Anael

family: Ubré

full_name: Marta Ubré

given: Marta

family: Roca

full_name: Josep Roca

given: Josep

family: Lacy

full_name: Antonio M. Lacy

given: Antonio M.

family: Burgos

full_name: Felip Burgos

given: Felip

family: Risco

full_name: Raquel Risco

given: Raquel

family: Momblán

full_name: Dulce Momblán

given: Dulce

family: Balust

full_name: Jaume Balust

given: Jaume

family: Blanco

full_name: Isabel Blanco

given: Isabel

family: Martínez-Pallí

full_name: Graciela Martínez-Pallí

given: Graciela

journal_name: Annals of Surgery

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Barberan-Garcia A, Ubre M, Pascual-Argente N, Risco R, Faner J, Balust J, Lacy AM, Puig-Junoy J, Roca J, Martinez-Palli G. Post-discharge impact and cost-consequence analysis of prehabilitation in high-risk patients undergoing major abdominal surgery: secondary results from a randomised controlled trial. Br J Anaesth. 2019 Oct;123(4):450-456. doi: 10.1016/j.bja.2019.05.032. Epub 2019 Jun 25.

full_name: A. Barberan-Garcia

given: A.

family: Ubre

full_name: M. Ubre

given: M.

family: Pascual-Argente

full_name: N. Pascual-Argente

given: N.

full_name: R. Risco

given: R.

family: Faner

full_name: J. Faner

given: J.

full_name: J. Balust

full_name: A.M. Lacy

family: Puig-Junoy

full_name: J. Puig-Junoy

full_name: J. Roca

family: Martinez-Palli

full_name: G. Martinez-Palli

given: G.

ipd_sharing_description: Anonymised data will be shared with Barcelona, Köln and Gdansk: all collected IPD

location_facility: Centre Hospitalier Universitaire Grenoble Alpes


title: Identification of Key Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais, Normandy and Picardy Regions

acronym: FRISC

summary:
Kidney transplantation is now the treatment of choice for end-stage renal disease (ESRD). Between 2800 and 3000 kidney transplants are performed each year in France and more than 33 000 patients are living with a functioning graft.

Preventing allograft rejection requires the use of immunosuppressive therapy, the intensity decreases as the distance from the day of transplantation. Unfortunately, treatment favors certain complications, including infectious and neoplastic. These represent a major cause of mortality in these patients. If the frequency of skin cancer is greatly increased in this population, that of solid tumors remains a concern. Approximately 20% of patients develop cancer after 10 years of graft , half non- skin cancers, the main risk factor is immunosuppressive therapy .

The aim of the study is to evaluate, in a large population of patients treated in 4 regions ( the Nord-Pas de Calais, the Upper and Lower Normandy and Picardy) risk factors (in particular the nature of the immunosuppressive treatment) of developing a neoplastic complication, skin cancers and solid tumors, after renal transplantation.

status: Unknown status

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU CAEN
Chu Rouen
CHU Amiens
Chru Lille

status_simplified: Unknown


title: Early Postoperative Recurrence in Crohn's Disease: Predictors of Research Targeting the Constitutional Mutation of IRGM

summary: Crohn's disease is a disease of complex etiology, multifactorial and still poorly understood. This disease, due to its morbidity and mortality, poses a significant public health problem in France. Apart from the involvement of bacterial factors and those involving the permeability of the epithelial barrier, it is now well recognized that several factors are associated with genetic predisposition in some of these patients. Among these factors, the Nod2 mutations were first identified. Studies concerning the presence of these mutations and the severity of disease results were sometimes conflicting. Very recently, new interesting mutations in genes involved in autophagy were found with greater frequency in patients with Crohn's disease. These mutations observed in Atg16 and IRGM genes. It has been particularly shown on large patient cohorts,the IRGM polymorphism was associated with a progressive disease, with histological severity scores. One of the severity criteria of Crohn's disease is the early recurrence observed in some patients after surgical resection of the injured segment. Predictive factors for such recurrence after surgery are not known or not.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
AP-HM
CHU de Grenoble
CHU de Nice
CHU de Montpellier


title: Impact of a Brief Motivational Intervention Including Counter-marketing Arguments With a Population of Patients With Moderate to Severe Alcohol Use Disorders Who Are Followed up on an Outpatient Basis (Primary Care or Addictology)

summary:
Alcohol consumption is the second cause of avoidable death after tobacco. The Evin law was constructed in 1991 with the aim of reducing exposure to alcohol marketing among the youngest. But this law is currently extremely weakened, and in a press release of February 26, 2018, the French Alcohol Society is alarmed by these developments.

Studies on the impact of alcohol marketing focus for the most part on young adolescents and the links between marketing exposure and alcohol initiation. But beyond these links, little work has been done on the impact of alcohol marketing on vulnerable subjects with regular alcohol consumption. Alcohol consumption is one of the very first causes of hospitalization in France. The damage is often limited to the notion of risks of dependence, but it can appear as soon as consumption of 1 standard unit/day and mainly concerns the 45-64 year olds. To our knowledge, there are no studies on the impact of alcohol marketing carried out among regular alcohol users with moderate or severe alcohol use disorders. This population is, however, the target of manufacturers, since 10% of the French population consumes 58% of the alcohol sold in France. Moreover, although in the context of tobacco, counter-marketing campaigns and strategies are used to help users develop resistance to the positive marketing stimuli of alcohol, there are no studies that have evaluated this type of intervention with patients with moderate to severe alcohol use disorders.

The DEPREV_phase 3 study is a prospective, controlled, randomised, open-label study.

Patients followed in the primary care network participating in the study and those followed in the addictology network of northern Finistère in the context of their pathology will be offered the opportunity to participate in the study.

Patients agreeing to participate will be randomized in 2 groups (1:1) by the addictology unit:

Control group: routine routine follow-up (follow-up in consultations with the attending physician or addictologist) + assessments at Month 1, Month 3 and Month 6.
Intervention group: Routine routine follow-up (follow-up in consultation with the attending physician or addictologist) + assessments at Month 1, Month 3 and Month 6 + motivational interview (2 individual sessions, during the first month after inclusion).

Patients will then be followed up and evaluated at 1, 3 and 6 months after the inclusion visit.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
ROZEC Pascale
SIMON Catherine
LE GOFF Delphine
Guillou Landreat
SIMSON Jean-Pierre
BARAIS Marie


title: Treatment of Mature B-cell Lymphoma/Leukaemia A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study

summary: This is an international trial conducted by three cooperative groups: SFOP (France, Belgium, Netherlands), CCG (USA, Canada, Australia), and UKCCSG (UK and Ireland). Children with mature B-cell lymphoma/leukaemia are stratified into three different risk groups (A, B, C) and receive treatment of progressive intensity. Randomized trials in the 2 biggest groups (B and C) test whether "reduced" therapy is equivalent to standard intensive therapy (LMB-89 B and C) in terms of event free survival. The reason for the modification is to reduce the long term toxicity which includes cardiotoxicity, impaired fertility and secondary malignancy. In group B, the modifications of treatment consists of a reduction of cyclophosphamide in COPADM2 and/or the elimination of COPADM3. In group C, the modification consists in a reduction of the doses in the CYVE courses and the elimination of the last 3 courses of maintenance treatment

ReferenceCitation: Frazer JK, Li KJ, Galardy PJ, Perkins SL, Auperin A, Anderson JR, Pinkerton R, Buxton A, Gross TG, Michon J, Leverger G, Weinstein HJ, Harrison L, Shiramizu B, Barth MJ, Goldman SC, Patte C, Cairo MS. Excellent outcomes in children and adolescents with CNS(+) Burkitt lymphoma or other mature B-NHL using only intrathecal and systemic chemoimmunotherapy: results from FAB/LMB96 and COG ANHL01P1. Br J Haematol. 2019 Apr;185(2):374-377. doi: 10.1111/bjh.15520. Epub 2018 Aug 16.

name: Paediatric Hematology‐Oncology University of Oklahoma Health Sciences Center Oklahoma City OKUSA

family: Frazer

full_name: J. Kimble Frazer

given: J. Kimble

family: Li

full_name: Kevin J. Li

given: Kevin J.

name: Paediatric Hematology‐Oncology Mayo Clinic Rochester MNUSA

family: Galardy

full_name: Paul J. Galardy

given: Paul J.

name: Pathology and ARUP Laboratories University of Utah Salt Lake City UT USA

family: Perkins

full_name: Sherrie L. Perkins

given: Sherrie L.

name: Biostatistics and Epidemiology Unit Gustave Roussy Villejuif France

family: Auperin

full_name: Anne Auperin

given: Anne

name: Frontier Science and Technology Research Foundation Madison WI USA

family: Anderson

full_name: James R. Anderson

given: James R.

name: University of Queensland Brisbane Queensland Australia

family: Pinkerton

full_name: Ross Pinkerton

given: Ross

name: Children's Oncology Group Monrovia CAUSA

family: Buxton

full_name: Allen Buxton

given: Allen

name: Center for Global Health National Cancer Institute National Institute of Health Rockville MD USA

family: Gross

full_name: Thomas G. Gross

given: Thomas G.

name: Paediatric Oncology Adolescent and Young Adult Department Institut CurieParisFrance

family: Michon

full_name: Jean Michon

given: Jean

name: Paediatric Haematology and Oncology Unit AP‐HP, Armand Trousseau Hospital UPMC Univ Paris 06 Paris France

family: Leverger

full_name: Guy Leverger

given: Guy

name: Paediatric Hematology‐Oncology Massachusetts General Hospital Harvard Medical School Boston MAUSA

family: Weinstein

full_name: Howard J. Weinstein

given: Howard J.

name: Paediatrics New York Medical College Valhalla NYUSA

family: Harrison

full_name: Lauren Harrison

given: Lauren

name: Paediatric Hematology‐Oncology University of Hawaii Honolulu HIUSA

family: Shiramizu

full_name: Bruce Shiramizu

given: Bruce

name: Paediatrics Roswell Park Cancer Institute Buffalo NYUSA

family: Barth

full_name: Mathew J. Barth

given: Mathew J.

name: Paediatric Hematology‐Oncology Medical City Children's Hospital Dallas TX USA

family: Goldman

full_name: Stanton C. Goldman

given: Stanton C.

name: Department of Cancerology for Children and Adolescents Gustave Roussy Villejuif France

family: Patte

full_name: Catherine Patte

given: Catherine

name: Medicine Pathology, Microbiology and Immunology, and Cell Biology and Anatomy New York Medical College Valhalla NY USA

family: Cairo

full_name: Mitchell S. Cairo

given: Mitchell S.

journal_name: British Journal of Haematology

evidence: open (via free article)

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

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

title: Excellent outcomes in children and adolescents with CNS + Burkitt lymphoma or other mature B‐ NHL using only intrathecal and systemic chemoimmunotherapy: results from FAB / LMB 96 and COG ANHL 01P1

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Morgan Stanley Childrens Hospital of New York Presbyterian


title: Evaluation of the Involvement of the Intestinal Microbiota and Choline Deficiency in the Severity of Chronic Liver Disease Explored by Analyzing Collection of Biological Samples

acronym: MICRONACH

summary:
Chronic liver diseases are common and the two main causes in France are NAFLD (No Alcoholic Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease).

Because of the importance of the current global obesity, NAFLD has become very common and it is estimated that its prevalence in the general population reaches 20-30%.

NAFLD (No Alcoholic Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease) includes a broad spectrum of liver damage, ranging from simple steatosis isolated (infiltration of fat in the liver), in hepatic inflammation, fibrosis (abnormally high accumulation of extracellular components in the functional liver tissue) and finally cirrhosis and its complications.

Choline deficiency (essential nutrient generally classified as Class B vitamins) has been associated with liver damage each characterizing NAFLD and ALD. The amount of choline in the body depends in particular on food intake and degradation of choline by the intestinal microbiota.

NAFLD and ALD are complex pathologies resulting from the interaction of environmental / nutritional factors and a genetic background. It therefore appears now necessary to study the influence of the relationship between genetic predisposition, environmental factors, and gut microbiota metabolism of choline on the severity of liver injury observed in NAFLD and ALD.

If the interaction of these three elements (the host genetics - environmental factors - and intestinal microbiota metabolic choline) has an influence on the severity of the lesions of NAFLD and ALD direct application may be of bring a food supplement choline in patients at risk (mutation of the PEMT gene (phosphatidylethanolamine N-methyltransferase), postmenopausal women, microbiota profile for increased degradation of dietary choline) to restore the amount of choline in the body and thus to avoid a worsening of the ALD or NAFLD and progression to cirrhosis.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
CHU Angers
CHU Toulouse
CHU Rennes
CHU Nantes


lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

acronym: GROWTH

location_facility:
Chu Grenoble
Chru Brest
HFME - Lyon Est
Hopital Croix Rousse Lyon
Chu Saint Etienne
Ch Roanne
Ch Lyon Sud Pierre Benite
Chu Clermont-Ferrand

type: EudraCT Number

source: euctr

title: Low-molecular-weight Heparin in Constituted Vascular Intrauterine Growth Restriction. Randomized Multicenter Trial

summary:
Intrauterine growth restriction (IUGR) is correlated to an abnormal placenta development, with an alteration of the maternal-fetal circulation, coagulation troubles, and apparition of placental infarcts. IUGR represents the third cause of perinatal mortality in France, and is associated to an important morbidity. For birth-weights < 10th percentile of the gestational age, the neonatal death risk is doubled, compared to abnormal weights. In 35% of cases, IUGR is of vascular origin and is included in the broader framework of placental vascular pathology (PVP).

Up to now, studies have focused on the primary or secondary prevention of PVP. Few studies have evaluated the treatment of constituted vascular IUGR. Currently, the management of vascular IUGR is mainly based on active surveillance, or termination of pregnancy. Pathological findings suggest that placental pro-thrombotic phenomena play a role in the constitution of vascular IUGR. Since aspirin is not effective in reducing this type of event, a randomized, open-label study conducted in China compared 14-day treatment with low-molecular-weight heparin (LMWH) versus Dan-Shen (a product not used in France) after diagnosis of IUGR. This trial, including 73 patients, showed a significant improvement in average growth kinetics in the LMWH group. The mean birth weight was 2877 g in the heparin group and 2492 g in the Dan-Shen group (p <0.0001). However, no data were provided concerning the number of newborns with a birth weight <10th percentile, i.e. the risk of morbidity and mortality, or complications occurring. Due to the lack of reliable data, LMWH are not included in the currently recommended therapeutic strategy for vascular IUGR.

The studies in IUGR reported to date mainly focused on primary or secondary prevention in women at risk of PVP, assessing the value of aspirin, which showed only a modest effect. No effective therapeutic strategy is available to treat patients with constituted vascular IUGR, a situation where LMWH should be more effective than antiplatelets given the vascular context.


title: Vascular Risk Factors and Coronary Calcifications in Chronic Renal Failure Patients: Identification of Specific Factors Linked to Renal Failure Progression

acronym: Pre-HD

summary: The aim of this study is to appreciate the influence of renal failure progression on vasculopathy (coronary calcifications and left ventricular hypertrophy) and cardiovascular risk factors.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Montpellier


title: Hypertensive Pregnant Women Monitored by Teletransmitted Self-measurements of Blood Pressure

acronym: FETH

summary: The occurrence of arterial hypertension (AH) during pregnancy is a major cause of fetal, neonatal and maternal morbidity and mortality in western countries. It is estimated that about 10% of pregnancies are complicated by AH (80 000 women / year in France). It is therefore essential to diagnose AH with certainty in order to set-up appropriate care and follow its evolution.

ReferenceCitation: Ashworth DC, Maule SP, Stewart F, Nathan HL, Shennan AH, Chappell LC. Setting and techniques for monitoring blood pressure during pregnancy. Cochrane Database Syst Rev. 2020 Jul 23;8:CD012739. doi: 10.1002/14651858.CD012739.pub2.

name: Department of Women and Children's Health; King's College London; London UK

family: Ashworth

full_name: Danielle C Ashworth

given: Danielle C

family: Maule

full_name: Sophie P Maule

given: Sophie P

name: Cochrane Children and Families Network, c/o Cochrane Pregnancy and Childbirth, Department of Women's and Children's Health; The University of Liverpool; Liverpool UK

family: Stewart

full_name: Fiona Stewart

given: Fiona

family: Nathan

full_name: Hannah L Nathan

given: Hannah L

family: Shennan

full_name: Andrew H Shennan

given: Andrew H

family: Chappell

full_name: Lucy C Chappell

given: Lucy C

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Rennes University Hospital

location_facility:
Hôpital Cochin (APHP)
CH St-Malo
CHU Caen
CHU Tours
CHU Lille

intervention_type: Device


title: Improvement of Social Adaptation After Pre-operative Cognitive Remediation in Parkinson's Patients Profiting From a Bilateral Subthalamic Stimulation

summary:
Main objective:

To assess the impact of a structured program of preoperative cognitive remediation on postoperative social adaptation in patients suffering from Parkinson's disease profiting from bilateral subthalamic nucleus stimulation.

Secondary objectives:

To assess in the same patients the impact of structured program of preoperative cognitive remediation on quality of life, mood, anxiety, apathy and psychologic, social and professional functioning depending on psychiatric symptomatology after intervention.

lead_sponsor: Central Hospital, Nancy, France

location_facility:
CHU de Nancy
CHU Clermont Ferrand
CHRU Strasbourg

intervention_type: Procedure


title: Prospective Study of Neutrophil Gelatinase Associated Lipocalin (NGAL)as a Biomarker of Mineralocorticoid Receiver Activity in Human: Proof of Concept.

summary: Aldosterone and its target the mineralocorticoid receptor are implied in development of cardiovascular disease such as arterial high blood pressure or cardiac failure. Serum aldosterone level is insufficient to know if the mineralocorticoid receptor is activated or not. The aim of this study is to identify biomarkers of mineralocorticoid receptor activity. The first "candidate biomarker" is Neutrophil gelatinase-associated lipocalin (NGAL) or "lipocalin" which being measured in blood or in the urine. According to scientific knowledge's evolution, others biomarkers could be tested later thanks to the blood or urinary samples taken during study.

location_facility: Unit of arterial high blood pressure of the Georges Pompidou Hospital


title: Effect of Enterally Administered Probiotics in Mechanically Ventilated Patients: Double-Blind, Prospective Randomized Study Versus Placebo

summary: The objective of this study is to assess the effects of a daily enteral supplementation with probiotics within a population of critically ill, mechanically ventilated patients. Especially, the effects of probiotics on mortality rate in intensive care medicine will be analysed.

status: Terminated

location_facility: Hopital Central, Service de Reanimation Medicale

intervention_type: Dietary Supplement


title: Efficacy of Thoraco-Lumbar Interfascial Plane (TLIP) Block for Postoperative Analgesia of Lumbar Spinal Fusion

acronym: ETLA

summary:
Spinal surgery is associated with severe pain in the immediate postoperative period. In a recent study evaluating pain intensity on the first day after surgery in a large range of surgical procedures, among the six most painful surgeries, three were major spinal procedures. Spinal surgery causes an accumulation of several types of pain. Incisional pain results from activation of peripheral nociceptors. Musculoskeletal pain arises from damage to structures, such as bone, ligaments, muscles, intervertebral disks, and zygapophyseal joints. In addition, neuropathic pain arises from compression and damage to nerve roots exiting the spinal canal and sometimes damage to the spinal cord itself.

Postoperative pain management requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA) in order to reduce opioid consumption after surgery. Among regional anesthesia (RA) techniques, the thoraco-lumbar interfascial plane block (TLIP) was considered. It offers an effective and safe analgesia during the first 24h after herniated lumbar disc surgery. Ultrasound-guided TLIP block involves injection of LAs between longissimus and multifidus muscles (spinal lombar muscles). This injection allows to block the dorsal rami of spinal nerves innervating the paravertebral muscles and the vertebrae.

The objective of this study is to evaluate the interest of TLIP block to improve the postoperative analgesia in patients undergoing lumbar spinal fusion surgery.

lead_sponsor: CMC Ambroise Paré

location_facility:
Clinique Rémusat
CMC Ambroise Paré
Hôpital Privé Jean Mermoz


title: Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation

acronym: Stim-Endom

summary:
6-10% of women of childbearing age suffer from endometriosis, which is mainly manifested by dysmenorrhea, non-menstrual pelvic pain and dyspareunia. Several treatment strategies, including surgical ones, are proposed but they are sometimes insufficient because endometriosis-related pain is frequently accompanied by sensitization. Endometriosis surgery, when indicated, is therefore changeably effective, even though the lesions have been completely resected. Patients therefore consult Pain Units seeking for the effective treatment as the pain persist even after surgical management of endometriosis.

Vagus nerve stimulation is a non-invasive technique that includes an anti-inflammatory effect and a modulation of neurotransmitter production (adrenaline, norepinephrine; serotonin, acetylcholine). Yuan and Silberstein published a general review on the technique. Migraine and depression are one of the selected indications. In addition, Napadow et al. published favourable results in a short series of patients with chronic pelvic pain. The Investigators of this study have treated some patients with this technique with a result deemed satisfactory which leads to propose a randomized study to confirm this impression.

lead_sponsor: Hopital Foch

location_facility:
Hopital Foch
CHI Poissy-St-Germain
Hopital Saint Joseph


title: Toi Même: a Mobile System for Measuring Bipolar Illness Activity - Feasibility Study

summary:
Bipolar disorder is a severe psychiatric illness with chronic course and it is associated with high risk of relapse and hospitalisation, and many patients do not recover to their previous psychosocial functioning. Major reasons for poor outcomes are delayed intervention for prodromal mood and behavioural symptoms as well as incomplete treatment responses. Current diagnostic approaches used to assess mood symptoms rely on symptom-based categories, which lack sensitivity to detect subtle mood and behavioural changes. Therefore, the ability to better characterizing bipolar patients may allow to detect possible differences in the illness activity.

On the other hand, there is a growing interest in the potential use of mobile technologies such as mobile apps, smartphone and internet in psychiatric care. Some projects have been testing the potential benefits of mobile apps to assess and treat individuals at-risk or suffering from mood and bipolar disorders, using online signs and symptoms monitoring, yet to the investigators knowledge, none of them have integrated a dimensional approach in a smartphone app to assess mood and behavioural alterations and bipolar illness activity, including subjective and objective data (e.g. physical activity, social activity, etc.).

In this feasibility study the investigators will evaluate the potential relevance of Toi Même app to self-monitoring mood and behavioural changes in bipolar patients with different mood phases compared to the gold-standard mood rating tools used in clinical practice. All patients will be followed for 3 months, with outcome assessments after 2 weeks, after 1 month, 2 months and after 3 months.

status: Suspended

primary_purpose: Supportive Care

ReferenceCitation: Dargél AA, Mosconi E, Masson M, Plaze M, Taieb F, Von Platen C, Buivan TP, Pouleriguen G, Sanchez M, Fournier S, Lledo PM, Henry C. Toi Même, a Mobile Health Platform for Measuring Bipolar Illness Activity: Protocol for a Feasibility Study. JMIR Res Protoc. 2020 Aug 18;9(8):e18818. doi: 10.2196/18818.

family: Dargél

full_name: Aroldo A Dargél

given: Aroldo A

family: Mosconi

full_name: Elise Mosconi

given: Elise

family: Masson

full_name: Marc Masson

given: Marc

family: Plaze

full_name: Marion Plaze

given: Marion

family: Taieb

full_name: Fabien Taieb

given: Fabien

family: Von Platen

full_name: Cassandra Von Platen

given: Cassandra

family: Buivan

full_name: Tan Phuc Buivan

given: Tan Phuc

family: Pouleriguen

full_name: Guillaume Pouleriguen

given: Guillaume

family: Sanchez

full_name: Marie Sanchez

given: Marie

family: Fournier

full_name: Stéphane Fournier

given: Stéphane

family: Lledo

full_name: Pierre-Marie Lledo

given: Pierre-Marie

family: Henry

full_name: Chantal Henry

given: Chantal

currency_apc_doaj: USD

journal_name: JMIR Research Protocols

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications

lead_sponsor: Institut Pasteur

location_facility: Nightingale Hospitals Paris - Clinique du Château

location_facility: Centre Thérapeutique et Preventif de Jour - Troubles Bipolaires (Clinique Bellevue)


title: Interest in Studying Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma : Exploratory Study

acronym: FibroRect

summary: Single center interventional study to explore activity of fibroblasts in the tumor and away in the healthy rectal tissue.

lead_sponsor: Institut Curie

location_facility:
Institut Curie - Hôpital René Huguenin
INSTITUT CURIE - Site Paris
Institut Curie


title: Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults. Phase 2 Trial

summary: DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in human. The purpose of this study is to determine if DHEA is effective in the treatment of respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease (COPD) on exercise capacity and haemodynamic variables. Patients will receive after randomisation either 25 mg/day or 200mg/day oral DHEA over a one-year period. Evaluation concerns clinical parameters, echocardiography and right catheterization after and before treatment. Primary end-point is the six-minute walk test. This is a prospective double blind, randomised, placebo controlled study which will be realized in four university hospitals in France : Bordeaux, Strasbourg, Toulouse and Limoges.

lead_sponsor: University Hospital, Bordeaux

location_facility:
University Hospital, Bordeaux
CHU de Limoges
CHU de Strasbourg
CHU de Toulouse


title: Dressing: Comparison of 3-day and 7-day Catheter Dressing Frequency and Efficacy of Antiseptic Impregnated Dressing in Preventing Catheter-related Infection in ICU

acronym: DRESSING

summary: The purpose of this study is to determine whether a catheter dressing every 7th day is not inferior to a catheter dressing every 3 days and if Chlorhexidine impregnated sponges are effective in preventing catheter-related infections in ICUs.

ReferenceCitation: Buetti N, Ruckly S, Schwebel C, Mimoz O, Souweine B, Lucet JC, Timsit JF. Chlorhexidine-impregnated sponge versus chlorhexidine gel dressing for short-term intravascular catheters: which one is better? Crit Care. 2020 Jul 23;24(1):458. doi: 10.1186/s13054-020-03174-0.

apc_source: openAPC

family: Buetti

full_name: Niccolò Buetti

given: Niccolò

family: Ruckly

full_name: Stéphane Ruckly

family: Schwebel

full_name: Carole Schwebel

given: Carole

family: Mimoz

full_name: Olivier Mimoz

given: Olivier

family: Souweine

full_name: Bertrand Souweine

given: Bertrand

family: Lucet

full_name: Jean-Christophe Lucet

given: Jean-Christophe

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

currency_apc_doaj: GBP

journal_name: Critical Care

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Timsit JF, Bouadma L, Mimoz O, Parienti JJ, Garrouste-Orgeas M, Alfandari S, Plantefeve G, Bronchard R, Troche G, Gauzit R, Antona M, Canet E, Bohe J, Herrault MC, Schwebel C, Ruckly S, Souweine B, Lucet JC. Jugular versus femoral short-term catheterization and risk of infection in intensive care unit patients. Causal analysis of two randomized trials. Am J Respir Crit Care Med. 2013 Nov 15;188(10):1232-9. doi: 10.1164/rccm.201303-0460OC.

family: Bouadma

full_name: Lila Bouadma

given: Lila

family: Parienti

full_name: Jean-Jacques Parienti

given: Jean-Jacques

family: Garrouste-Orgeas

full_name: Maïté Garrouste-Orgeas

given: Maïté

family: Alfandari

full_name: Serge Alfandari

given: Serge

family: Plantefeve

full_name: Gaétan Plantefeve

given: Gaétan

family: Bronchard

full_name: Régis Bronchard

given: Régis

family: Troche

journal_name: American Journal of Respiratory and Critical Care Medicine

title: Jugular versus Femoral Short-Term Catheterization and Risk of Infection in Intensive Care Unit Patients. Causal Analysis of Two Randomized Trials

ReferenceCitation: Timsit JF, Bouadma L, Ruckly S, Schwebel C, Garrouste-Orgeas M, Bronchard R, Calvino-Gunther S, Laupland K, Adrie C, Thuong M, Herault MC, Pease S, Arrault X, Lucet JC. Dressing disruption is a major risk factor for catheter-related infections. Crit Care Med. 2012 Jun;40(6):1707-14. doi: 10.1097/CCM.0b013e31824e0d46.

title: Dressing disruption is a major risk factor for catheter-related infections*

ReferenceCitation: Schwebel C, Lucet JC, Vesin A, Arrault X, Calvino-Gunther S, Bouadma L, Timsit JF. Economic evaluation of chlorhexidine-impregnated sponges for preventing catheter-related infections in critically ill adults in the Dressing Study. Crit Care Med. 2012 Jan;40(1):11-7. doi: 10.1097/CCM.0b013e31822f0604.

title: Economic evaluation of chlorhexidine-impregnated sponges for preventing catheter-related infections in critically ill adults in the Dressing Study*

ReferenceCitation: Timsit JF, Schwebel C, Bouadma L, Geffroy A, Garrouste-Orgeas M, Pease S, Herault MC, Haouache H, Calvino-Gunther S, Gestin B, Armand-Lefevre L, Leflon V, Chaplain C, Benali A, Francais A, Adrie C, Zahar JR, Thuong M, Arrault X, Croize J, Lucet JC; Dressing Study Group. Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults: a randomized controlled trial. JAMA. 2009 Mar 25;301(12):1231-41. doi: 10.1001/jama.2009.376.

title: Chlorhexidine-Impregnated Sponges and Less Frequent Dressing Changes for Prevention of Catheter-Related Infections in Critically Ill Adults

location_facility: grenoble university hospital (medical ICU and surgical ICU)

location_facility: University hospital Bichat Claude Bernard


acronym: GENKYST

summary: Genkyst is a regional cohort involving up to nephrologists working in private and public nephrology centers in the West of France. It registers clinical and molecular genetic data of all consenting patients with ADPKD from this area.

location_facility: Centre Nephrologie et Dialyse d Armorique


title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 on Cerebrospinal Fluid Biomarkers in 36 Patients With Progressive Supranuclear Palsy

summary: A phase 2 study to assess tolerability, safety, pharmacokinetics and effect of AZP2006 at different doses versus placebo on cerebrospinal fluid biomarkers in 36 patients with progressive supranuclear palsy. The patient study duration is 29 weeks including a washout period.

lead_sponsor: AlzProtect SAS

location_facility: Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix

location_facility: Hôpital de la Fondation Adolphe de Rothschild


title: The VEPRO Trial: A Cross-Over Randomised Controlled Trial Comparing 2 Corrective Lenses for Patients With Presbyopia

acronym: VEPRO

summary: The VEPRO trial is a cross-over randomised controlled trial comparing 2 corrective lenses for patients with presbyopia. The aim of the study is to compare the effectiveness of two corrective lenses: an old generation (Varilux Comfort Orma Crizal) and a new generation (Varilux Panamic Orma Crizal) of corrective lenses prescribed in presbyopia.

ReferenceCitation: Boutron I, Touizer C, Pitrou I, Roy C, Ravaud P. The VEPRO trial: a cross-over randomised controlled trial comparing 2 progressive lenses for patients with presbyopia. Trials. 2008 Sep 19;9:54. doi: 10.1186/1745-6215-9-54.

family: Boutron

full_name: Isabelle Boutron

given: Isabelle

family: Touizer

full_name: Caroline Touizer

given: Caroline

family: Pitrou

full_name: Isabelle Pitrou

family: Roy

full_name: Carine Roy

given: Carine

family: Ravaud

full_name: Philippe Ravaud

given: Philippe

journal_name: Trials

publisher_dissemination: Springer

publisher_group: Springer

title: The VEPRO trial: A cross-over randomised controlled trial comparing 2 progressive lenses for patients with presbyopia

lead_sponsor: Santéclair

location_facility: INSERM, U738, Paris, France ; Université Paris 7 Denis Diderot, UFR de Médecine, Paris, France ; AP-HP, Hôpital Bichat, Département d'Epidémiologie, Biostatistique et Recherche Clinique


title: Evaluation of Insulin Therapy by Multiwave Bolus Based on the Lipid and Protein Content in Addition to the Carbohydrates Content Compared to Insulin Therapy Based Only on the Carbohydrates Content in type1 Diabetes Treated by Insulin Pump

summary:
The aim of the study is to evaluate the effect of insulin therapy when the bolus dose of insulin is calculated on the basis of protein and fat content in food intake, in addition to that of carbohydrates in T1D patients treated by insulin pump. The study is planned to recruit 150 patients with type1 diabetes already practicing functional insulin therapy based on carbohydrate counting in meals. We will therefore study the effect on continuous glucose measured by subcutaneous sensor, of meal bolus adjustments by comparing two groups of T1D patients:

Groupe A takes into account the lipid and protein content in addition to the carbohydrate content
Group B takes into account the carbohydrate content only At randomization, all patients receive dietary and adjustment of bolus doses instructions according to the randomization group. They have to apply these instructions for 3 months. At the end of 3 months, the study groups will be under glucose monitoring during two weeks in the Outpatient Clinic but returns to the investigational site in hospital to download data from the continuous measurement of glucose. In addition, we propose a period of extension similar to that of the main period, namely 3 months of application of dietetic and adaptation of bolus doses instructions and 2 weeks of continuous measurement of glucose.

During each 2 weeks period will be assessed specific glucose parameters in the post-prandial period over 4hours (glycemic sensor values in the glucose range between 70-140 mg / dl, glycemic sensor values in the glucose range between 140 -180 mg /dl and > 180 mg /dl) after taking each meal during the 13 days of Glucose Continuous Measurement (GCM), average daily glucose per meal, average blood glucose over the 13-day period after each meal.

location_facility: Service Endocrinologie Diabète Nutrition

location_facility: Structure d'Endocrinologie, Diabète et Nutrition

location_facility: Service de diabétologie, maladies métaboliques et nutrition

location_facility: Service d'Endocrinologie, Diabétologie et Nutrition

location_facility: Service d'Endocrinologie-Métabolisme et Diabétologie-Nutrition

location_facility: Service d'endocrinologie et maladies métaboliques


ipd_sharing_description: IPD can be shared upon request to the sponsor

lead_sponsor: UNICANCER

location_country: Italy France

location_facility:
Fondazione IRCCS
Gustave Roussy Cancer Campus

title: A Double-blind Randomised Phase III Trial Evaluating the Efficacy of ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability and Not Elected for Docetaxel or Androgen Receptor Targeted Agents

summary: This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of androgen deprivation therapy (ADT) +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors.


lead_sponsor: Hospices Civils de Lyon

acronym: CORTI-Covid

location_facility: Hôpital Pneumologique et Cardiovasculaire Louis Pradel

ipd_sharing: Undecided

title: Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection

summary:
Infection with the SARS-Cov-2 virus, responsible of severe acute respiratory distress syndrome (SARS), is an emerging infectious disease called Covid-19 and declared as pandemic by the World Health Organization on March 11, 2020. This pandemic is responsible of significant mortality. In France, several thousand patients are hospitalized in intensive care units, and their number continues to increase. Mortality during Covid-19 is mainly linked to acute respiratory distress syndrome, which frequency is estimated in France to occur in 6% of infected patients. Comorbidities such as cardiovascular conditions, obesity and diabetes increase susceptibility to severe forms of Covid-19 and associated mortality. Therapeutic management has three components: symptomatic management, including supplementary oxygen therapy and in case of respiratory distress mechanical ventilation; the antiviral approach; and immunomodulation, aiming at reducing inflammation associated with viral infection, which is considered to take part in severe presentations of the disease.

During Covid-19 viral pneumonia related to SARS-COv-2, there is a significant release of pro-inflammatory cytokines in the acute phase of viral infection, which could participate in viral pneumonia lesions. In children with less mature immune system than adults, SARS-Cov-2 infection is less severe. The current prevailing assumption is that severe forms of Covid-19 may not only be related to high viral replication, but also to an excessive inflammatory response favoring acute lung injury and stimulating infection.

The investigators hypothesize that early control of the excessive inflammatory response may help reducing the risk of acute respiratory distress syndrome.

The investigators will evaluate the benefit, safety and tolerability of corticosteroid therapy to reduce the rate of subjects hospitalized for Covid-19 viral pneumonia who experience clinical worsening with a need of high-flow supplemental oxygen supplementation or transfer in intensive care units for respiratory support.


title: Light Therapy for Chronic Insomnia in General Practice: a Randomized Double Blind Study

acronym: Insolux

summary:
Sleep disorders, especially insomnia
Attention deficits (or disorders), daytime somnolence and drug dependence
The goal is to evaluate whether light therapy could be used as an efficient alternative treatment with direct application in general practice

lead_sponsor: University Hospital, Strasbourg, France

location_facility:
University of Nantes
Hôpitaux Universitaires de Strasbourg
CHU Reims


title: Evaluation of the Renal Congestion, Perfusion and Function Before and After Diuretic Treatment in the ICU

acronym: ECHOFURO

summary:
Renal congestion is a pathological state that can lead to acute kidney failure. Furosemide is known to lower renal congestion by its diuretic effect.

The aim of this trial is to study the reversibility of kidney congestion under diuretic therapy and assess through echodoppler parameters if it can improve renal perfusion and function in congestive ICU patients.

It could in fine lead to a better identification of patients that could benefit from diuretic therapy in the ICU.

location_facility: Les Hôpitaux Universitaires de Strasbourg


title: Assistance in Neurosurgery by Extemporaneous Analysis of Magnetic Resonance of the Metabolic Content in Excised Tissues (ExtempoRMN)

acronym: ExtempoRMN

summary:
The main ambition of this project is to develop, and provide the medical community, an innovative method to analyze extemporaneously, during a neurosurgery operation, excised tissues. This method is based on the analysis of the metabolic profile of excised tissues by the technique of High-Resolution Magic-Angle Spinning (HR-MAS) Nuclear Magnetic Resonance (NMR) spectroscopy. Indeed HRMAS NMR method can provide in a sufficiently short time lapse (currently about 30 minutes but within our project a time lapse of 15 min or even less is ultimately intended), medical information that can complement those obtained by classic histological examination.

Primary purpose:

The main objective of this study is to determine the sensitivity of HRMAS NMR spectroscopy in detecting residual tumor infiltration at the brain resection cavity. The investigators aim to determine the relevance of the metabolic analysis compared to histological analysis during a neurosurgery operation. This involves analyzing excised tissue samples, obtained from the operating rooms of Strasbourg University Hospitals, and Colmar Hospital Center, with no return to neurosurgeon for surgery.

Secondary purposes:

The secondary objectives of the protocol are to investigate the metabolome of different types of brain tumors, in order to find prognostic and diagnostic markers. It consists in detecting metabolomic factors of bad prognosis, and potential marker of good prognosis such as the IDH mutation.

location_facility: Service de Biophysique et de Médecine Nucléaire, Hôpital de Hautepierre


title: Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses

summary:
Patellofemoral pain syndrome is one of the most common musculoskeletal disorders. It is defined as an anterior knee pain. Its origin is a conflict during patellar tracking, due to patellofemoral malalignment and soft tissue overload.

A few recent studies seem to show a benefit of prefabricated feet orthoses in patellofemoral pain syndrome, alone or in association with rehabilitation. However, no one has analyzed the outcome of morpho-specific foot orthoses in a prospective randomized study.

The purpose of this prospective randomized study is to compare clinical outcomes in daily living and in sports activities, between morpho-specific and placebo foot orthoses.

Morpho-specific foot orthoses are designed according to the patient's morphotype. They are intended to correct structural defects of the hindfoot, midfoot and forefoot, in the aim to correct abnormal overload during patellofemoral tracking.

location_facility: Service de Chirurgie Orthopédique - Hôpital CCOM - Hôpitaux Universitaires de Strasbourg


title: Clinical Evaluation of Daptomycin Bone Penetration

acronym: DAPTO-HUS

summary: Bone and joint infections are commonly due to Gram-positive bacteria. Treatment of these infections is difficult because of the need of prolonged duration of antimicrobial agents in combination with surgical procedure. Moreover, in recent years, a growing resistance pattern to various antimicrobial agents has been observed for Gram-positive bacteria. Consequently, there is an urgent need for new drugs with high bone penetration for the treatment of those infections. The investigators hypothesized that daptomycin allow to achieve high concentrations in bone compartments.

location_facility: Service des maladies infectieuses et tropicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

location_facility: Service d'Orthopédie - Hôpital Centre de Chirurgie Orthopédie et de la Main (CCOM) - Hôpitaux Universitaires de Strasbourg - 10 av Achille Baumann -

location_facility: Plateau Technique de Microbiologie - Hôpitaux Universitaires de Strasbourg - 1, rue Koeberlé


title: Beneficial Effects of Exercise Training on Physical Capacity in Type 2 Diabetics: Improvement in Skeletal Muscle Energetic Capacity, Endothelial Dysfunction and Glycemic Control

summary: The aim of this study is to evaluate the improvement in skeletal muscle energetic capacity, endothelial dysfunction and glycemic control induced by physical training in 20 sedentary patients with a type 2 diabetes.The protocol consists in a physical training program with 3 sessions of 30 minutes per week during six consecutive weeks. A skeletal muscle biopsy, a cardiac and humeral artery ultrasounds, a glycemic and tensional holters will be performed before and at the end of the physical training program.

location_facility: Médecine Interne et Nutrition, Hôpital Civil, Hôpitaux universitaires de Strasbourg

location_facility: Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg

location_facility: Service de Physiologie et d'Explorations Fonctionnelles, Nouvel Hôpital Civil, Hôpitaux universitaires de Strasbourg

intervention_type: Behavioral


title: MRI Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri

summary: To evaluate the diagnosis value of MRI and positon emission tomography (PET) scan for studying macrophagic infiltration and other brain modification in multiple sclerosis (MS) patients treated with Natalizumab (Tysabri).

location_facility: Service de Neurologie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Radiologie 2, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Médecine Nucléaire, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg


title: Prevention of Graft Reinfection After Liver Transplantation for HCV Related End-stage Liver Disease . Study of Humoral Anti-HCV Response

summary: End stage HCV-related cirrhosis has become a major indication for liver transplantation (LT). Unfortunately, recurrence of HCV infection on the liver graft occurs in almost all patients following transplantation and causes a persistent infection that leads to chronic hepatitis and cirrhosis in a significant proportion of patients. To date there is no effective way to prevent HCV reinfection of the liver graft in the early phase after transplantation. . Early passive immunotherapy with neutralizing antibodies against HCV should be considered for preventing reinfection of liver transplanted patients associated with HCV. This approach is well established in the case of patients undergoing liver transplantation for chronic hepatitis B virus infection. Our purpose is to produce neutralizing monoclonal antibodies to prevent reinfection of the liver graft.

location_facility: Service de Chirurgie Générale et Transplantation Multiorganes - Hôpital de Hautepierre

location_facility: Service d'Hépato-Gastro-Entérologie - Hôpital Civil

location_facility: Service d'Hématologie et Oncologie - Hôpital de Hautepierre


title: Effects of Oral Chronic L-Arginine Supplementation on Exercise and Renal Function of Heart Transplant Recipients

summary:
exercise capacities are still altered after heart transplantation partly due to peripheral endothelial dysfunction
cyclosporin-induced renal dysfunction may be due to renal endothelial dysfunction and can be reversed in an animal model by L-arginine supplementation
to determine the potential beneficial effect of L-arginine supplementation on exercise capacity and renal function of heart transplant recipients

location_facility: Service des Explorations Fonctionnelles Respiratoires et de l'Exercice


title: Determinants and Consequences of the Transition to Adulthood Among Adolescents With Haemophilia - TRANSHEMO

acronym: TRANSHEMO

summary:
Severe haemophilia is a rare disease characterized by spontaneous bleedings from early childhood, which may lead to various complications especially in joints. Due to advances in medical care and more specifically in the development of prophylactic strategies by the application of clotting factor concentrates, life expectancy of persons with severe haemophilia has significantly increased over the last decades. This progress requires a long-term follow-up, including into adulthood. The adherence to a regular clinical follow-up and to a prophylactic treatment then depends on how successful patients' transition from childhood to adulthood has been as this process involves a transfer of responsibility from parents to patients concerning the management of their health. Beyond the issue of patients' adherence, a suboptimal transition may also impair quality of life and the entry into adulthood, especially at the social, emotional and professional levels. Only a few studies have been conducted to identify the specific needs and difficulties young persons with severe haemophilia experience during their transition from childhood to adulthood, and none of these studies has been carried out in France where the features of the health care system are very specific.

Therefore, this study aims to address the issue of transition into adulthood among young persons with severe haemophilia in France. This study will focus not only on the facilitators and barriers of the access to health care but also, from a more global perspective, on all the specific concerns and difficulties they may experience as they grow into adulthood which may impair their long-term health related quality of life as well as their personal empowerment. This study will also allow to identify some of the socio- cognitive, emotional, and familial determinants of a good transition into adulthood.

ReferenceCitation: Resseguier N, Rosso-Delsemme N, Beltran Anzola A, Baumstarck K, Milien V, Ardillon L, Bayart S, Berger C, Bertrand MA, Biron-Andreani C, Borel-Derlon A, Castet S, Chamouni P, Claeyssens Donadel S, De Raucourt E, Desprez D, Falaise C, Frotscher B, Gay V, Goudemand J, Gruel Y, Guillet B, Harroche A, Hassoun A, Huguenin Y, Lambert T, Lebreton A, Lienhart A, Martin M, Meunier S, Monpoux F, Mourey G, Negrier C, Nguyen P, Nyombe P, Oudot C, Pan-Petesch B, Polack B, Rafowicz A, Rauch A, Rivaud D, Schneider P, Spiegel A, Stoven C, Tardy B, Trossaërt M, Valentin JB, Vanderbecken S, Volot F, Voyer-Ebrard A, Wibaut B, Leroy T, Sannie T, Chambost H, Auquier P. Determinants of adherence and consequences of the transition from adolescence to adulthood among young people with severe haemophilia (TRANSHEMO): study protocol for a multicentric French national observational cross-sectional study. BMJ Open. 2018 Jul 25;8(7):e022409. doi: 10.1136/bmjopen-2018-022409.

family: Resseguier

full_name: Noémie Resseguier

given: Noémie

family: Rosso-Delsemme

full_name: Natacha Rosso-Delsemme

given: Natacha

family: Beltran Anzola

full_name: Any Beltran Anzola

given: Any

family: Baumstarck

full_name: Karine Baumstarck

given: Karine

family: Milien

full_name: Vanessa Milien

given: Vanessa

family: Ardillon

full_name: Laurent Ardillon

given: Laurent

family: Bayart

full_name: Sophie Bayart

given: Sophie

family: Berger

full_name: Claire Berger

given: Claire

family: Bertrand

full_name: Marie-Anne Bertrand

given: Marie-Anne

family: Biron-Andreani

full_name: Christine Biron-Andreani

given: Christine

family: Borel-Derlon

full_name: Annie Borel-Derlon

given: Annie

family: Castet

full_name: Sabine Castet

given: Sabine

family: Chamouni

full_name: Pierre Chamouni

given: Pierre

family: Claeyssens Donadel

full_name: Ségolène Claeyssens Donadel

given: Ségolène

family: De Raucourt

full_name: Emmanuelle De Raucourt

given: Emmanuelle

family: Desprez

full_name: Dominique Desprez

given: Dominique

family: Falaise

full_name: Céline Falaise

given: Céline

family: Frotscher

full_name: Birgit Frotscher

given: Birgit

family: Gay

full_name: Valérie Gay

given: Valérie

family: Goudemand

full_name: Jenny Goudemand

given: Jenny

family: Gruel

full_name: Yves Gruel

given: Yves

family: Guillet

full_name: Benoît Guillet

given: Benoît

family: Harroche

full_name: Annie Harroche

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

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille Hôpital de la Timone


title: Cardiovascular Risk Prevention Among Night Workers

acronym: Heart-Of-Night

summary:
With around 15 to 20% of workforce engaging in nightshift work in modern society for obvious economic and social reasons, the consequences of night work on cardiovascular risks are substantial. Compared to day workers, it was reported higher risks of cardiovascular diseases (estimated at 40%) and of metabolic syndrome (1.5 times) in shift workers. The occurrence of metabolic syndrome increases the risk to develop high blood pressure, diabetes and cardiovascular events. Because some characteristics of night work are potentially modifiable, some preventive strategies could be applied to reduce its adverse effects. For shift workers, some recent guidelines (High Health Authority, 2012 & 2016) and fruitful literature propose to develop regular assessments of cardiovascular risk factors and occupational activities, and stress the need to expand preventive strategies. Moreover, some recent French laws provide an opportunity to implement preventive interventions and specific monitoring through the occupational physicians network. However, whether the concept is defined, the exact content, method and the potential benefits are unknown. The investigator assume that individual advice related to collective countermeasures referenced on guidelines (applied on worksite within plant) could lead a better improvement on incidence of metabolic syndrome compared to those that benefit only individual advice.

Main objective:

To measure the benefit from implementation of individual and collective prevention (dispensed in worksites within plants) on metabolic syndrome compared to strategy relying only on individual prevention among night workers, over 2 years' follow-up. The secondary objectives of the study are to evaluate in both groups:

Observance of different types of preventive strategies
Impact of observance of preventive advice on metabolic syndrome in shift workers and on each component of metabolic syndrome
Determinants which promote the up-take of preventive strategies among night workers
The countermeasures which could be applied and effective within company 5) Medico-economic assessment is planned from an ancillary study.

lead_sponsor: University Hospital, Toulouse

location_facility: Toulouse University Hospital (CHU de Toulouse)


title: Caregiver Serological Monitoring Extended Secondarily to Patients With the SARS-CoV-2 Coronavirus

summary:
Hospital mortality attributed to SARS-CoV-2 in France increased daily by 28% in the week before confinement. The week following this decision, the daily increase was 30%. During the week of the second week of confinement, it started a decline of 19% estimated over the last 5 days, reaching the cumulative number of 2606 deaths on 29/3 (site https://www.eficiens.com/coronavirus- personal statistics / and calculation).

The diagnosis of viral carriage by RT-PCR is reserved for symptomatic cases among caregivers, due to the shortage of available tests and the cumbersome implementation. The carrier diagnosis is the benchmark, on which are implemented the therapeutic strategies and established the national statistics. It can present false negatives, linked to a research too early or too late in relation to the infection, or to a technical defect of the nasal swab sample. Caregivers on the front line in patient care, in hospitals or in the city, have only partial access to this diagnostic test, depending on the existence of symptoms. The implementation of a systematic serological screening, planned by the government and which cannot be based only on the search for the virus, will make it possible to inform the caregivers presenting symptoms or not, of their serological status, and therefore of their degree immunity or, on the contrary, susceptibility to infectious contacts. It should therefore be very voluntarily requested. On the occasion of this screening, the constitution of the COVID-3S cohort will make it possible to verify the degree of contamination in an asymptomatic population, information which is sorely lacking for the estimation of the immune coverage of the population. The implementation of the Covid-3S study will be based on the work of the National Reference Center of Pr B Lina, from the COVID-SER cohort, for the selection of the most efficient test (s). It seems useful to initiate the constitution of this cohort as soon as possible in relation to the evolution of the epidemic. Pending receipt of official recommendations, the lack of knowledge of the performance of serological tests means that it should be applied first to health professionals, better able to appreciate its limits, for the initial period before determining a validated serological screening strategy. Once the strategy has been specified, the gradual expansion of screening to the patient population will provide a more representative basis for the construction of epidemiological models for evaluating strategies.

location_facility:
CHU de Grenoble - Hôpital Nord
CHU de Saint Etienne
Hôpital de la Croix Rousse
Hôpital Henry Gabrielle


title: Treatment of Bullous Pemphigoid With Avdoralimab (IPH5401), an Anti-C5aR1 Monoclonal Antibody

acronym: IPH

summary:
The development of Auto Immune bullous Diseases (AIBD) results from a complex interaction between innate and adaptive immune systems. Bullous pemphigoid (BP), the most frequently encountered AIBD, predominantly affects elderly patients above 70 with an estimated incidence of 21.7 new cases/million/year in France.Interestingly, coversin, an anti-C5a and -leukotriene B4 small molecule, is currently used in a phase IIA clinical trial in BP patients (NCT04035733). However, although overall C5-blocking drugs are potentially interesting, they are likely to interfere with C5a-C5aR2-axis activation as well, a pathway that has recently proved protective in BP 12. The main objective is to investigate the clinical efficacy of an anti-C5aR1 antibody in addition to superpotent topical steroids compared to superpotent topical steroids alone in BP patients at 3 months.It is a case-controlled, randomized, open-labelled, and multicenter phase II clinical trial. Four Dermatologic French centers (Nice, Marseille Nord, Marseille Timone and Montpellier university hospitals) specialized in the in the care of BP patients will be participating in the study. It is expected that forty subjects will be included in this trial.

Conversely, a more targeted inhibition of C5a-C5aR1 axis might be more effective in BP, sparing the potentially protective effect of C5a-C5aR2 interaction.

Avdoralimab (IPH5401), a specific anti-C5aR1 monoclonal antibody, has already been credited of a good safety profile in the treatment of solid tumors and rheumatoid arthritis. The investigators hypothesize that avdoralimab might be a safe and effective treatment in BP patients

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU Montpellier, Dermatologie
CHU de Nice- Dermatologie
APHM, Hôpital Nord
APHM, Timone


title: Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device

acronym: VPASH

summary:
Sleep Apnea Syndrome (SAS) is a common pathology affecting between 4 and 8% of the general population. It aggravates morbidity and cardio-metabolic mortality and is responsible for accidents related to vigilance disorders. It is estimated that 80%% of SAS cases are not diagnosed and therefore not treated. It is however impracticable to propose a diagnostic test of polygraphy (PG) or polysomnography (PSG) to every patient because of the cost and insufficient availability of these exams. It would therefore be useful to carry out a screening test before directing the patient to a complete test.

Several simplified polygraph systems with 2 or 3 channels have been proposed (nasal cannula, oximetry, heart rate) but they generally record only one night and remain intrusive enough to perturb the sleep.

The Withings HWA09 is a wrist-worn watch, which allows screening of SAS from four signals: movement, heart rate, breathing rate and blood oxygen saturation (SpO2). The objective of the present study is to validate the diagnostic performance of the Withings HWA09 for the detection of SAS compared to PSG.

lead_sponsor: Withings

location_country: Belgium France

location_facility:
St Pierre Hospital
Antoine Béclère Hospital


title: Predictive Factors Associated With Impairment in Functional Autonomy in a Regional Real-life Cohort of Patients With Alzheimer's Disease or Related Disorders (ADRD)

acronym: MEM-AURA

summary:
The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases because of their main features such as cognitive impairment, loss of functional autonomy and behavioural disorders. In absence of current curative treatment, the identification of the predictive risk factors of progression of the disease, evaluated through its main symptoms, represents a major stake of public health. The Investigators aim at developing a regional database, which includes the patient medical records on a prospective basis, in collaboration with the medical and administrative staff and with the University hospital computer science departments.

The main objective is to study the predictive factors associated with change in functional autonomy level, measured every 6 to 12 months in memory centres across Region Auvergne Rhone-Alpes in France.

The real-life study population will consist in about 5250 patients with ADRD. The inclusion period will be of 3 years, the length of follow-up of each patient will be of 10 years max for a total study length of 13 years.

primary_purpose: Health Services Research

location_facility: Centre Mémoire de Ressources et de Recherche de Lyon


title: Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery : Multicenter Randomized Clinical Trial

acronym: AIVOC-ANI

summary: The Physiodoloris (MetroDoloris, Lille, France) monitor, CE marqued, uses the ECG signal in order to compute the Analgesia Nociception Index (ANI) which has been shown to measure the relative parasympathetic tone, and hence to reflect the analgesia/nociception balance during general anesthesia. The primary endpoint of this randomized multicenter study is to measure whether there is a benefit to use the ANI in order to adapt remifentanil administration during propofol anesthesia for laparoscopic surgery. Primary endpoint : lesser proportion of patients presenting with at least one episode of hemodynamic reactivity, hypotension or bradycardia in the ANI guided group vs control group ?

lead_sponsor: University Hospital, Lille

location_facility:
University Hospital Claude Huriez
University Hospital Roger Salengro
University Hospital
Clinique privée d'ANTONY
University Hospital Erasme (ULB)