acronym: MIG-HD

summary: The aim of this study is to assess the clinical benefit of intrastriatal grafting of human cells from the foetal ganglionic eminence in patients with Huntington's disease. The duration of the study will be 52 months. A first group of patients will be grafted at M13-14 (early G group) and a second group of patients will be grafted at M33-34 (late G group). The principal criterion is the comparison of the progression between M12 and M32 of the motor score (TMS) of the UHDRS between grafted patients (early G group) and not yet grafted patients (late G group). An additional evaluation will be performed to compare the progression in individual patients over the 52-month study period. We will thus be able to compare the pre and post-graft TMS progression for all patients.

ReferenceCitation: Bachoud-Lévi AC, Rémy P, Nguyen JP, Brugières P, Lefaucheur JP, Bourdet C, Baudic S, Gaura V, Maison P, Haddad B, Boissé MF, Grandmougin T, Jény R, Bartolomeo P, Dalla Barba G, Degos JD, Lisovoski F, Ergis AM, Pailhous E, Cesaro P, Hantraye P, Peschanski M. Motor and cognitive improvements in patients with Huntington's disease after neural transplantation. Lancet. 2000 Dec 9;356(9246):1975-9.

ReferenceCitation: Bachoud-Lévi AC; on behalf the Multicentric Intracerebral Grafting in Huntington's Disease Group. Human Fetal Cell Therapy in Huntington's Disease: A Randomized, Multicenter, Phase II Trial. Mov Disord. 2020 Aug;35(8):1323-1335. doi: 10.1002/mds.28201. Epub 2020 Jul 15.

name: Assistance Publique‐Hôpitaux de Paris, National Reference Center for Huntington's Disease, Neurology Department Henri Mondor‐Albert Chenevier Hospital  Créteil France

name: Equipe neuropsychologie interventionnelle, Département d’études cognitives École normale supérieure, PSL, Research University, Institut Mondor de Recherche biomédicale, Université Paris‐Est, INSERM, Paris, and Créteil  France

name: Faculté de Santé Université Paris Est  Créteil France

family: Bachoud‐Lévi

full_name: Anne‐Catherine Bachoud‐Lévi

given: Anne‐Catherine

family: Schramm

full_name: Catherine Schramm

given: Catherine

family: Remy

full_name: Philippe Remy

given: Philippe

family: Aubin

full_name: Ghislaine Aubin

given: Ghislaine

family: Blond

full_name: Serge Blond

given: Serge

family: Bocket

full_name: Laurence Bocket

given: Laurence

family: Brugières

full_name: Pierre Brugières

given: Pierre

family: Calvas

full_name: Fabienne Calvas

given: Fabienne

family: Calvier

full_name: Elisabeth Calvier

given: Elisabeth

family: Cassim

full_name: François Cassim

given: François

family: Challine

full_name: Dominique Challine

given: Dominique

family: Gagou

full_name: Clarisse Scherer Gagou

given: Clarisse Scherer

family: Langavant

full_name: Laurent Cleret Langavant

given: Laurent Cleret

family: Collier

full_name: Francis Collier

given: Francis

family: Cottencin

full_name: Olivier Cottencin

given: Olivier

family: David

full_name: Philippe David

family: Damier

full_name: Philippe Damier

family: Delliaux

full_name: Marie Delliaux

given: Marie

family: Delmaire

full_name: Christine Delmaire

given: Christine

family: Delval

full_name: Arnaud Delval

given: Arnaud

family: Démonet

full_name: Jean‐François Démonet

given: Jean‐François

family: Descamps

full_name: Philippe Descamps

family: Gaura

full_name: Véronique Gaura

given: Véronique

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

repository_institution: Cardiff University - ORCA Online Research @Cardiff

ReferenceCitation: Schramm C, Katsahian S, Youssov K, Démonet JF, Krystkowiak P, Supiot F, Verny C, Cleret de Langavant L, Bachoud-Lévi AC; European Huntington's Disease Initiative Study Group and the Multicentre Intracerebral Grafting in Huntington's Disease Group. How to Capitalize on the Retest Effect in Future Trials on Huntington's Disease. PLoS One. 2015 Dec 29;10(12):e0145842. doi: 10.1371/journal.pone.0145842. eCollection 2015.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

title: How to Capitalize on the Retest Effect in Future Trials on Huntington’s Disease

ReferenceCitation: Teichmann M, Gaura V, Démonet JF, Supiot F, Delliaux M, Verny C, Renou P, Remy P, Bachoud-Lévi AC. Language processing within the striatum: evidence from a PET correlation study in Huntington's disease. Brain. 2008 Apr;131(Pt 4):1046-56. doi: 10.1093/brain/awn036. Epub 2008 Mar 11.


title: Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis

summary:
The purpose of this study is to evaluate whether carotid angioplasty with stent (CAS) is as safe and effective as carotid surgery in regards to:

the risk of stroke and death within 30 days of the procedure;
the long-term risk of ipsilateral carotid territory stroke, in patients with recently symptomatic, severe carotid stenosis suitable for both CAS and carotid endarterectomy.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Mas JL, Chatellier G, Beyssen B, Branchereau A, Moulin T, Becquemin JP, Larrue V, Lièvre M, Leys D, Bonneville JF, Watelet J, Pruvo JP, Albucher JF, Viguier A, Piquet P, Garnier P, Viader F, Touzé E, Giroud M, Hosseini H, Pillet JC, Favrole P, Neau JP, Ducrocq X; EVA-3S Investigators. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med. 2006 Oct 19;355(16):1660-71.

ReferenceType: derived

ReferenceCitation: Howard VJ, Algra A, Howard G, Bonati LH, de Borst GJ, Bulbulia R, Calvet D, Eckstein HH, Fraedrich G, Greving JP, Halliday A, Hendrikse J, Jansen O, Brown MM, Mas JL, Ringleb PA, Brott TG; Carotid Stenosis Trialists' Collaboration. Absence of Consistent Sex Differences in Outcomes From Symptomatic Carotid Endarterectomy and Stenting Randomized Trials. Stroke. 2021 Jan;52(2):416-423. doi: 10.1161/STROKEAHA.120.030184. Epub 2021 Jan 25.

name: Department of Epidemiology (V.J.H.), School of Public Health, University of Alabama at Birmingham.

family: Howard

full_name: Virginia J. Howard

given: Virginia J.

sequence: first

name: Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus and Julius Center for Health Sciences and Primary Care (A.A.), and Julius Centre for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, the Netherlands.

family: Algra

full_name: Ale Algra

given: Ale

sequence: additional

name: Department of Biostatistics (G.H.), School of Public Health, University of Alabama at Birmingham.

full_name: George Howard

given: George

name: Department of Brain Repair and Rehabilitation, Stroke Research Centre, University College of London Queen Square Institute of Neurology, University College London, United Kingdom (L.H.B., M.M.B.).

name: Department of Neurology, Stroke Center (L.H.B.), University Hospital Basel, University of Basel, Switzerland.

name: Department of Clinical Research (L.H.B.), University Hospital Basel, University of Basel, Switzerland.

family: Bonati

full_name: Leo H. Bonati

given: Leo H.

name: Department of Vascular Surgery (G.J.d.B.), and Julius Centre for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, the Netherlands.

family: de Borst

full_name: Gert J. de Borst

given: Gert J.

name: Clinical Trial Service Unit and Epidemiological Studies Unit (R.B.), Nuffield Department of Population Health, University of Oxford, United Kingdom.

name: Medical Research Council Population Health Research Unit (R.B.), Nuffield Department of Population Health, University of Oxford, United Kingdom.

family: Bulbulia

full_name: Richard Bulbulia

given: Richard

name: Department of Neurology, Hopital Sainte-Anne, Universite Paris-Descartes, DHU Neurovasc Sorbonne Paris Cite, INSERM U894, France (D.C., J.-L.M.).

family: Calvet

full_name: David Calvet

given: David

name: Department of Vascular and Endovascular Surgery/Vascular Center, Klinikum rechts der Isar der Technischen Universitat Munchen, Munich, Germany (H.-H.E.).

family: Eckstein

full_name: Hans-Henning Eckstein

given: Hans-Henning

name: Department of Vascular Surgery, Medical University of Innsbruck, Austria (G.F.).

family: Fraedrich

full_name: Gustav Fraedrich

given: Gustav

name: Department of Epidemiology (J.P.G.), and Julius Centre for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, the Netherlands.

family: Greving

full_name: Jacoba P. Greving

given: Jacoba P.

name: Nuffield Department of Surgical Sciences, John Radcliffe Hospital, Oxford, United Kingdom (A.H.).

family: Halliday

full_name: Alison Halliday

given: Alison

name: Department of Radiology, University Medical Center Utrecht, the Netherlands (J.H.).

family: Hendrikse

full_name: Jeroen Hendrikse

given: Jeroen

name: Department of Radiology and Neuroradiology, UKSH Campus Kiel, Germany (O.J.).

family: Jansen

full_name: Olav Jansen

given: Olav

family: Brown

full_name: Martin M. Brown

given: Martin M.

family: Mas

full_name: Jean-Louis Mas

given: Jean-Louis

name: Department of Neurology, University of Heidelberg Medical School, Germany (P.A.R.).

family: Ringleb

full_name: Peter A. Ringleb

given: Peter A.

name: Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).

family: Brott

full_name: Thomas G. Brott

given: Thomas G.

name: on behalf of the Carotid Stenosis Trialists’ Collaboration

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Stroke

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: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

repositories_institution: University College London - UCL Discovery

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Müller MD, von Felten S, Algra A, Becquemin JP, Bulbulia R, Calvet D, Eckstein HH, Fraedrich G, Halliday A, Hendrikse J, Howard G, Gregson J, Jansen O, Brown MM, Mas JL, Brott TG, Ringleb PA, Bonati LH. Secular Trends in Procedural Stroke or Death Risks of Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis. Circ Cardiovasc Interv. 2019 Aug;12(8):e007870. doi: 10.1161/CIRCINTERVENTIONS.119.007870. Epub 2019 Aug 5.

name: Department of Neurology and Stroke Center (M.D.M. and L.H.B.), University Hospital Basel, University of Basel, Switzerland.

name: Department of Clinical Research, Clinical Trial Unit (S.v.F.), University Hospital Basel, University of Basel, Switzerland.

name: Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus and Julius Center for Health Sciences and Primary Care (A.A.), University Medical Center Utrecht, Utrecht University, the Netherlands.

name: Vascular Institute Paris East, Hôpital privé Paul D’Egine, Ramsay Group, Champigny sur Marne, France (J.-P.B.).

name: Department of Neurology, Hôpital Sainte-Anne, Université Paris-Descartes, DHU Neurovasc Sorbonne Paris Cité, INSERM U894, France (D.C., J.-L.M.).

name: Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical University of Munich, Germany (H.-H.E.).

name: Department of Radiology (J.H.), University Medical Center Utrecht, Utrecht University, the Netherlands.

name: Department of Biostatistics, UAB School of Public Health, Birmingham, AL (G.H.).

name: Department of Medical Statistics, London School of Hygiene and Tropical Medicine, United Kingdom (J.G.).

name: Clinic for Radiology and Neuroradiology, Universitätsklinikum  Schleswig-Holstein Campus Kiel, Germany (O.J.).

name: Department of Brain Repair and Rehabilitation, Stroke Research Centre, UCL Queen Square Institute of Neurology, University College London, United Kingdom (M.M.B., L.H.B.).

name: for the Carotid Stenosis Trialists’ Collaboration

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories:
PubMed Central
UCL Discovery
www.zora.uzh.ch

repositories_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Müller MD, von Felten S, Algra A, Becquemin JP, Brown M, Bulbulia R, Calvet D, Eckstein HH, Fraedrich G, Halliday A, Hendrikse J, Gregson J, Howard G, Jansen O, Mas JL, Brott TG, Ringleb PA, Bonati LH; Carotid Stenosis Trialists' Collaboration. Immediate and Delayed Procedural Stroke or Death in Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis. Stroke. 2018 Nov;49(11):2715-2722. doi: 10.1161/STROKEAHA.118.020684.

name: From the Department of Neurology and Stroke Center (M.D.M., L.H.B.), University Hospital Basel, University of Basel, Switzerland

name: Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus and Julius Center for Health Sciences and Primary Care (A.A.), University Medical Center Utrecht, the Netherlands

name: Vascular Institute Paris East, Hôpital privé Paul D’Egine, Ramsay Group, France (J.-P.B.)

name: Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, University College London, United Kingdom (M.B., L.H.B.)

name: MRC Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, Oxford University, United Kingdom (R.B.)

name: Department of Radiology (J.H.), University Medical Center Utrecht, the Netherlands

name: Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.)

ReferenceCitation: Rantner B, Kollerits B, Roubin GS, Ringleb PA, Jansen O, Howard G, Hendrikse J, Halliday A, Gregson J, Eckstein HH, Calvet D, Bulbulia R, Bonati LH, Becquemin JP, Algra A, Brown MM, Mas JL, Brott TG, Fraedrich G; Carotid Stenosis Trialists' Collaboration. Early Endarterectomy Carries a Lower Procedural Risk Than Early Stenting in Patients With Symptomatic Stenosis of the Internal Carotid Artery: Results From 4 Randomized Controlled Trials. Stroke. 2017 Jun;48(6):1580-1587. doi: 10.1161/STROKEAHA.116.016233. Epub 2017 Apr 28.

name: From the Department of Vascular Surgery (B.R., G.F.) and Division of Genetic Epidemiology, Department of Medical Genetics, Molecular and Clinical Pharmacology (B.K.), Medical University of Innsbruck, Austria; Cardiovascular Associates of the Southeast, Birmingham, AL (G.S.R.); Department of Neurology, University of Heidelberg Medical School, Germany (P.A.R.); Clinic for Radiology and Neuroradiology, UKSH Campus Kiel, Germany (O.J.); Department of Biostatistics, UAB School of Public Health,...

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_institution: University of Oxford - Oxford University Research Archive (ORA)

ReferenceCitation: Mas JL, Arquizan C, Calvet D, Viguier A, Albucher JF, Piquet P, Garnier P, Viader F, Giroud M, Hosseini H, Hinzelin G, Favrole P, Hénon H, Neau JP, Ducrocq X, Padovani R, Milandre L, Rouanet F, Wolff V, Saudeau D, Mahagne MH, Sablot D, Amarenco P, Larrue V, Beyssen B, Leys D, Moulin T, Lièvre M, Chatellier G; EVA-3S Investigators. Long-term follow-up study of endarterectomy versus angioplasty in patients with symptomatic severe carotid stenosis trial. Stroke. 2014 Sep;45(9):2750-6. doi: 10.1161/STROKEAHA.114.005671. Epub 2014 Jul 31.

name: From the Hôpital Sainte-Anne, Université Paris-Descartes, INSERM U894, DHU Neurovasc-Paris Sorbonne, Paris, France (J.-L.M., D.C.); Hôpital Gui de Chauliac, Université Montpellier 1, Montpellier, France (C.A.); Hôpital Rangueil (A.V., V.L.) and Hôpital Purpan (J.-F.A.), Université Paul Sabatier, Toulouse, France; Hôpital de la Timone, Université de la Méditerranée, Marseille, France (P.P., L.M.); Hôpital Nord, Université Jean Monnet, Saint-Etienne, France (P.G.); Hôpital Côte de Nacre, Université de...

title: Long-Term Follow-Up Study of Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis Trial

ReferenceCitation: Rantner B, Goebel G, Bonati LH, Ringleb PA, Mas JL, Fraedrich G; Carotid Stenting Trialists' Collaboration. The risk of carotid artery stenting compared with carotid endarterectomy is greatest in patients treated within 7 days of symptoms. J Vasc Surg. 2013 Mar;57(3):619-626.e2; discussion 625-6. doi: 10.1016/j.jvs.2012.08.107. Epub 2012 Dec 11.

ReferenceCitation: Mas JL, Trinquart L, Leys D, Albucher JF, Rousseau H, Viguier A, Bossavy JP, Denis B, Piquet P, Garnier P, Viader F, Touzé E, Julia P, Giroud M, Krause D, Hosseini H, Becquemin JP, Hinzelin G, Houdart E, Hénon H, Neau JP, Bracard S, Onnient Y, Padovani R, Chatellier G; EVA-3S investigators. Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial. Lancet Neurol. 2008 Oct;7(10):885-92. doi: 10.1016/S1474-4422(08)70195-9. Epub 2008 Sep 5.

location_facility: Sainte-Anne Hospital: Department of Neurology


title: Contribution of a Psycho-Educational Program of Help to Help in the Pharmacological Assumption of Responsibility of the Disease of Alzheimer

summary: The aim of the project is to demonstrate that a psycho-educational programme designed to support and train carers of Alzheimer's disease (AD) patients induces a significantly higher benefit than anticholinesterase drug treatment alone or associated to memantine treatment. This training programme focuses on the explanation/description of behavioral, cognitive and functional disorders induced by the disease, as well as principles of cognitive and psycho-social stimulation of the patients in daily life.

primary_purpose: Health Services Research

ReferenceType: background

ReferenceCitation: Wenisch E, Stoker A, Bourrellis C, Pasquet C, Gauthier E, Corcos E, Banchi MT, De Rotrou J, Rigaud AS. [A global intervention program for institutionalized demented patients]. Rev Neurol (Paris). 2005 Mar;161(3):290-8. French.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Completed


title: Contrast-Enhanced US of Spleen, Liver and Kidney in Patients With Acute Infection (Malaria and Other Infectious Diseases: a Functional Study

summary:
To evaluate the changes in the microcirculation of the liver, kidney and spleen during acute infection in patients with malaria (cohorts 1 and 3) and other infectious diseases such as acute pyelonephritis at day 0 (within 8 hours of the treatment start), day 2 to 4 and day 28-32, using functional US with continuous infusion of a contrast agent (SonoVue, Bracco, Italy).

Study hypothesis: malaria patients should exhibit a different pattern of enhancement, particularly when quantitative measurements of the SU signals is performed with destruction reperfusion kinetics.

status: Unknown status

study_type: Observational

time_perspective: Prospective

location_facility: Department of Adult Radiology, Necker University Hospital

status_simplified: Unknown


title: Measurement of Expiratory Flow Variability for the Detection of Bronchospasm in Infants Using the Ventica® Device by Revenio

acronym: VENTICA

summary:
Wheezing in infants and children less than 3 years of age children is a frequent feature that might be difficult to diagnose when only the caregivers reporting is available. Indeed, in this age group the usual reversible flow limitation measure during pulmonary function testing (PFT) is missing because PFT techniques require the full patient cooperation to perform respiratory tests. Infants PFTs have been developed to measure the same indexes than those measured in adults, but they are difficult to set-up and require medication- induced sleep during day time. However, when flow limitation is sufficient it can be detected during tidal breathing as measured during spirometry using pneumotachograph (PNT). In this test, the tidal breathing flow-volume (TBFV) loop is recorded and studied using different indices to assess the airflow limitation. But, there again, when addressing infants or very young children quiet breathing can only be achieved during sleep and medication- induced sleep necessary.

Impedance pneumography (IP) is a method for measuring changes in the thoracic electrical impedance through skin electrodes, which varies as a function of lung aeration i.e. breathing. This technique has mainly been applied to monitor respiratory rate in intensive care settings, but recent technical advancements in IP signal processing and electrode placement strategy have enabled IP to be used for accurate non-invasive tidal flow signal measurement. Compared to direct PNT, high agreement in flow signal and TBFV indices has been demonstrated in young children as well as in infants, even during induced bronchoconstriction. Moreover, in overnight recordings at home, IP was found feasible for quantifying nocturnal TBFV variability in young children with lower respiratory symptoms. In this study, it was shown that preschool children with high risk of asthma present with increased variation of tidal flow profile shape, and momentarily lowered chaoticity, compared to children with lower risk of asthma.

Recently a study in Tampere University Hospital (TAUH) Allergy centre (Tampere, Finland, PSHP ethical committee code R14027, ClinicalTrials.gov code NCT02164968) finished collecting overnight TBFV using impedance pneumography on 70 young children with suspected asthma. The preliminary analysis of this data shows that the effect of asthma treatment can be seen in TBFV variability, but to assess the diagnostic capacity of this new method, healthy control sample should be collected.

The technology developed by the Finnish medical device company Revenio Research Oy enables to evaluate the variability of the expiratory flow-volume curve. It is calculate as the expiration variability index (EVI) which is decreased in case of bronchoconstriction.

In order to explore very young children (less than 3 years of age) unable to participate to any awake lung function test, we set-up a study aiming to: 1) establish reference value for EVI in healthy children 2 months to 3 years old 2) test the variation of EVI in case of acute disease with or without wheezing in this age group children.

In this observational prospective multicenter study, we will include 110 asymptomatic healthy subjects to compute reference values of EVI. We will also include 35 previously healthy subjects who have developed an acute non wheezing disease such as fever, rhinitis, otitis or bronchitis to compare their EVI to the reference values. And finally, we will recruit 35 young subjects with an acute wheezing episode. All measurements will be performed at home by the parents, except for some wheezy children who could be hospitalized. It will be proposed to record 2 consecutive nights in healthy asymptomatic children in order to evaluate the night-to-night variability which has already shown to be small in older children.

In this multicentre study 120 children will be recruited by the present study in France and the remaining 60 children in another English centre using the same design and technology.

It is expected that only children with acute wheezing episode will have a significantly low EVI compare to the reference values established by this study.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

intervention_type: Device

status_simplified: Ongoing


title: Eighteen Months of Oral Anticoagulant Therapy Versus Placebo After 6 Six Months of Anticoagulation for a First Episode of Idiopathic Pulmonary Embolism: a Multicentre Double-blind Randomized Controlled Trial. "PADIS-PE" Study.

acronym: PADIS EP

summary:
Rational: After 3 or 6 months of oral anticoagulation for an episode of acute venous thromboembolism (VTE), the risk of recurrent VTE is high (10 to 15% per year) in comparison with a low risk of recurrence if VTE was provoked by a major transient risk factor such as recent surgery (3% per year) independently of the initial presentation (deep vein thrombosis or pulmonary embolism). After a first episode of idiopathic VTE, 3 months of anticoagulation is associated with a very high risk of recurrence (27% per year); however, the benefit-risk of extended duration of anticoagulation (1 to 2 years) remains uncertain, mainly in relation with an increased risk of anticoagulant related bleeding. Therefore, the last ACCP conference group recommended 6 months of oral anticoagulant therapy after a first episode of idiopathic VTE. However, this recommendation is likely to be inadequate for at least two main reasons: (1) no studies compared 2 years to 6 months of anticoagulation after idiopathic VTE; and (2), if the frequency of recurrent VTE is similar after deep vein thrombosis and pulmonary embolism, however, the case fatality rate of recurrent VTE is higher after pulmonary embolism (12%) than after deep vein thrombosis (5%).

Objective : the main objective is to demonstrate that, after 6 months of oral anticoagulation for a first episode of idiopathic pulmonary embolism, 18 months of warfarin therapy is associated with a lower cumulative risk of recurrent VTE and major bleeding in comparison with that on 18 months of placebo. The secondary objectives are: (1) to determine the risk of recurrent VTE after 6 months of warfarin therapy and the presence or the absence of residual lung scan perfusion defect and the persistence or not of elevated D-dimer test; and (2), to determine the impact of extended duration of anticoagulation on the risk of VTE after stopping anticoagulant therapy on a follow-up of 2 years.

Method : French multicenter double blind randomized controlled trial. Inclusion and exclusion criteria and pulmonary diagnostic criteria have been defined. After completing 6 months of oral anticoagulation, a lung scan and D-dimer testing are performed; the investigators and the patients will be unaware of the results of these tests. Then, patients are randomized to receive 18 months of warfarin therapy or 18 months of placebo (the dose of placebo will be adapted according to false computer generated INR). The investigators, the radiologists and the patients are blinded of the treatment allocation. The project will be submitted to national ethical committee and written consent will be obtained from all included patients.

Required number of patients: the expected cumulative frequency of recurrent VTE and major bleeding over 18 months is 4.5% while on warfarin therapy and 16% while on placebo. For a α risk of 5% (to falsely conclude to a true difference) and a β risk of 10% (to falsely conclude to an absence of difference), 178 patients per group should be included. As 5% of patients are expected to be loss, a total of 374 patients is required.

Feasibility: about 50 patients per year are hospitalized in our department of medicine in Brest for an acute episode of idiopathic pulmonary embolism. Four additional centers will participate to the study and have a similar recruitment: HEGP (Pr Meyer, Dr Sanchez), CHU Antoine Béclère (Dr Parent, Pr Simmoneau), CHU Saint Etienne (Pr Mismetti, Pr Décousus), CHU Grenoble (Pr Pison, Pr Carpentier). The study will be coordinated by the Clinical Center of Investigation of Brest Hospital; "true" and "false" INR will be generated by the clinic of anticoagulant of "Ile de France" (Dr Cambus).

Clinical implications: the first consequence of the study is to demonstrate that 6 months of warfarin therapy is inadequate and should be continued for at least 18 additional months after a first episode of idiopathic pulmonary embolism. This study has also the potential to confirm or not the contribution of lung scan and D-dimer testing to appreciate the risk of recurrent VTE after stopping anticoagulant therapy. Lastly, the medical economical impact of such therapeutic management will be evaluated.

primary_purpose: Treatment

ReferenceCitation: Raj L, Presles E, Le Mao R, Robin P, Sanchez O, Pernod G, Bertoletti L, Jego P, Lemarié CA, Leven F, Hoffmann C, Planquette B, Le Roux PY, Slaun PY, Nonent M, Girard P, Lacut K, Mélac S, Guégan M, Mismetti P, Laporte S, Meyer G, Leroyer C, Tromeur C, Couturaud F; PADIS-PE Investigators. Evaluation of Venous Thromboembolism Recurrence Scores in an Unprovoked Pulmonary Embolism Population: A Post-hoc Analysis of the PADIS-PE trial. Am J Med. 2020 Aug;133(8):e406-e421. doi: 10.1016/j.amjmed.2020.03.040. Epub 2020 Apr 22.

family: Raj

full_name: Leela Raj

given: Leela

family: Presles

full_name: Emilie Presles

given: Emilie

family: Le Mao

full_name: Raphael Le Mao

given: Raphael

family: Robin

full_name: Philippe Robin

given: Philippe

family: Sanchez

full_name: Olivier Sanchez

given: Olivier

family: Pernod

full_name: Gilles Pernod

given: Gilles

family: Bertoletti

full_name: Laurent Bertoletti

given: Laurent

family: Jego

full_name: Patrick Jego

given: Patrick

family: Lemarié

full_name: Catherine A. Lemarié

given: Catherine A.

family: Leven

full_name: Florent Leven

given: Florent

family: Hoffmann

full_name: Clément Hoffmann

given: Clément

family: Planquette

full_name: Benjamin Planquette

given: Benjamin

family: Le Roux

full_name: Pierre-Yves Le Roux

given: Pierre-Yves

family: Slaun

full_name: Pierre-Yves Slaun

family: Nonent

full_name: Michel Nonent

given: Michel

family: Girard

full_name: Philippe Girard

family: Lacut

full_name: Karine Lacut

given: Karine

family: Mélac

full_name: Solen Mélac

given: Solen

family: Guégan

full_name: Marie Guégan

given: Marie

family: Mismetti

full_name: Patrick Mismetti

family: Laporte

full_name: Silvy Laporte

given: Silvy

family: Meyer

full_name: Guy Meyer

given: Guy

family: Leroyer

full_name: Christophe Leroyer

given: Christophe

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Bretagne Occidentale

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

ReferenceCitation: Raj L, Robin P, Le Mao R, Presles E, Tromeur C, Sanchez O, Pernod G, Bertoletti L, Jego P, Leven F, Lemarié CA, Martin A, Planquette B, Le Roux PY, Salaun PY, Nonent M, Girard P, Lacut K, Melac S, Mismetti P, Laporte S, Meyer G, Leroyer C, Couturaud F; PADIS-PE Investigators. Predictors for Residual Pulmonary Vascular Obstruction after Unprovoked Pulmonary Embolism: Implications for Clinical Practice-The PADIS-PE Trial. Thromb Haemost. 2019 Sep;119(9):1489-1497. doi: 10.1055/s-0039-1692424. Epub 2019 Jun 23.

name: Faculty of Heath Science, McMaster University, Hamilton, Ontario, Canada

name: Service de Médecine Nucléaire and EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France

name: Unité de recherche clinique, Innovation et pharmacologie, Centre Hospitalo-Universitaire de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, Saint-Etienne, France

name: Université Paris Descartes, Université Sorbonne Paris Cité, Service de Pneumologie et de soins intensifs, Hôpital Européen Georges Pompidou, AP-HP; Université Paris Descartes, Sorbonne Paris Cité, and INSERM UMR S 1140, Paris, France

name: Service de Médecine Vasculaire et Thérapeutique, Unité de Pharmacologie Clinique, CIC1408, Centre Hospitalo-Universitaire de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, Saint-Etienne, France

name: Service de Cardiologie and EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France

name: Service d'Echo-doppler Vasculaire, and EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France

name: Département Thoracique, Institut Mutualiste Montsouris, Paris, France

title: Predictors for Residual Pulmonary Vascular Obstruction after Unprovoked Pulmonary Embolism: Implications for Clinical Practice—The PADIS-PE Trial

ReferenceCitation: Couturaud F, Sanchez O, Pernod G, Mismetti P, Jego P, Duhamel E, Provost K, dit Sollier CB, Presles E, Castellant P, Parent F, Salaun PY, Bressollette L, Nonent M, Lorillon P, Girard P, Lacut K, Guégan M, Bosson JL, Laporte S, Leroyer C, Décousus H, Meyer G, Mottier D; PADIS-PE Investigators. Six Months vs Extended Oral Anticoagulation After a First Episode of Pulmonary Embolism: The PADIS-PE Randomized Clinical Trial. JAMA. 2015 Jul 7;314(1):31-40. doi: 10.1001/jama.2015.7046.

name: Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France2Groupe d’Investigation et de Recherche Clinique sur la Thrombose (GIRC Thrombose)

name: Groupe d’Investigation et de Recherche Clinique sur la Thrombose (GIRC Thrombose)3Service de Pneumologie, Hôpital Européen Georges Pompidou, AP-HP; Université Paris Descartes, Sorbonne Paris Cité, and INSERM UMR S 970, Paris, France

name: Groupe d’Investigation et de Recherche Clinique sur la Thrombose (GIRC Thrombose)4Département de Médecine Vasculaire, Centre Hospitalo-Universitaire de Grenoble, Université de Grenoble 1, Grenoble, France

name: Groupe d’Investigation et de Recherche Clinique sur la Thrombose (GIRC Thrombose)5Service de Médecine et Thérapeutique, Unité de Pharmacologie Clinique, Centre Hospitalo-Universitaire de Saint-Etienne, and EA3065, Université Jean Monnet, Saint-Etienne, Fr

name: Groupe d’Investigation et de Recherche Clinique sur la Thrombose (GIRC Thrombose)6Service de Médecine Interne, Centre Hospitalo-Universitaire de Rennes, Université de Rennes 1, Rennes, France

name: Groupe d’Investigation et de Recherche Clinique sur la Thrombose (GIRC Thrombose)7Service de Médecine Interne, Centre Hospitalier Général de Saint-Brieuc, Saint-Brieuc, France

name: Service de Cardiologie, Centre Hospitalier Général de Lannion, Lannion, France

name: Clinique des Anticoagulants d’Ile de France (C.R.E.A.T.I.F.), Centre Hospitalo-Universitaire de Lariboisière, Paris, France

name: Groupe d’Investigation et de Recherche Clinique sur la Thrombose (GIRC Thrombose)10Unité de recherche clinique, Innovation et pharmacologie, Centre Hospitalo-Universitaire de Saint-Etienne, and EA3065, Université Jean Monnet, Saint-Etienne, France

name: Service de Cardiologie and EA 4324, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France

name: Groupe d’Investigation et de Recherche Clinique sur la Thrombose (GIRC Thrombose)12Service de Pneumologie and INSERM 999, Centre Hospitalo-Universitaire de Kremlin Bicêtre, Kremlin Bicêtre, France

name: Groupe d’Investigation et de Recherche Clinique sur la Thrombose (GIRC Thrombose)13Service de Médecine Nucléaire and EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest France

name: Groupe d’Investigation et de Recherche Clinique sur la Thrombose (GIRC Thrombose)14Service d’Echo-doppler Vasculaire, and EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France

name: Groupe d’Investigation et de Recherche Clinique sur la Thrombose (GIRC Thrombose)15Service de Radiologie, and EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France

name: Pharmacie Centrale, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France

name: Groupe d’Investigation et de Recherche Clinique sur la Thrombose (GIRC Thrombose)17Département Thoracique, Institut Mutualiste Montsouris; Paris, France

name: Groupe d’Investigation et de Recherche Clinique sur la Thrombose (GIRC Thrombose)18Centre d’Investigation Clinique and UMR CNRS 5525, Centre Hospitalo-Universitaire de Grenoble, Université de Grenoble 1, Grenoble, France


type: Other Identifier

title: Impact of Sport Practice and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects. Physiological Pilot Study

acronym: ASRHACOLS

summary: The study of circulating tumoral DNA makes it possible to study, without invasive procedures or pathological studies, the tumoral DNA circulating in the blood of a patient and its various alterations. In patients with colon-rectal cancer with resected tumor, circulating tumor DNA can be used as a predictive biomarker of metastatic relapse of cancer. However, the routine extension of circulating tumoral DNA remains limited due to several difficulties. One of the pifalls that circulating tumor DNA is greatly diluted by healthy circulating DNA from non-tumor cells. The amount of healthy circulating DNA has been described as being influenced by certain physiological parameters. The aim of the study is to increase knowledge on the influence of physiological factors associated with sports activity and meal on the release kinetics of circulating DNA.

design_allocation: Non-Randomized

primary_purpose: Basic Science

ipd_sharing: Yes

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

location_facility: Assistance Publique Hôpitaux de Paris, Hôpital européen Georges Pompidou

intervention_type: Other


title: Evaluation of the Radiological Dose Delivered to Risky Interventional Cardiology Patients (Optidose)

acronym: Optidose

summary: The purpose of this study is therefore to study the actual doses of X-rays delivered to the patient's skin during recanalization of a coronary artery in a context of Chronic Total Occlusion

study_start_date_type: Actual

status: Recruiting

lead_sponsor: Ramsay Générale de Santé

intervention_type: Radiation

lead_sponsor_type: industriel


title: Dissociative Disorders in Obesity

acronym: Dissobe

summary: THe aim of this study is to determine the frequency of dissociative tendencies in the obese population treated at the CELIOBE (Liberal Center for Obesity Support) at Hôpital Privé La Louvière among patients consulting for the first time and looking for a medical or surgical course. The DES scale of Carlson and Putman will be used.


title: Study of the Impact of a Social Telepresence Robot on Social Isolation and Loneliness of the Elderly at Home

acronym: DOMIROB

summary: The main purpose of this monocentric, prospective study is to measure the impact of the implementation of a robotic social telepresence tool, during three months at home, on the feeling of loneliness and social isolation of the elderly

lead_sponsor: Gérond'if


title: Impact of Omalizumab Withdrawal After a 3 Year Duration Treatment in Well Controlled Severe Allergic Asthma : a Multicentric Randomized Controlled Trial

acronym: SHORTEN

summary:
The optimal duration of the treatment by OMA remains unclear when asthma is well controlled. Data suggest that a large part of patients with well controlled asthma can discontinue OMA therapy without any asthma control deterioration or with an acceptable decrease in asthma control, therefore French experts propose that omalizumab can be given for "3 to 5 yrs if asthma remains well controlled".

The costs related to OMA are high and frequent injections represent severe constraints for patients. For all these reasons, evaluating whether shortening duration of OMA therapy is feasible while maintaining acceptable asthma control is a critical point. Therefore, the aim of this study is to evaluate asthma control after OMA discontinuation after 3 to 5 years of treatment when asthma is well controlled.

ipd_sharing_description:
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.


title: Survival and Quality of Life After Liver Transplantation in Patients Aged 65 and Over

summary: The main objective of this non-interventional, single-center study is to assess survival and associated factors at 1 year in patients aged 65 and over who received liver transplantation

location_facility: Geriatric Department, Paul Brousse Hospital


type: Other Grant/Funding Number

title: Observational Multicenter Registry to Assess the Enefits of Active Sentry Handpiece During Cataract Surgery With the Centurion Phacoemulsifier (SASCA)

acronym: SASCA

summary:
Each new generation of phacoemulsification system has aimed to optimize the control of fluidics and the delivery of energy during phacoemulsification. Nicoli CM et al., (J Cataract Refract Surg 2016;42:157-162) suggested a better anterior chamber stability when using an active fluidics system. Malik PK et al., (Eye and Vision 2017;4:22) showed that using an IOP based phacoemulsification system in association with the use of an Intrepid balanced tip provides a reduction in CDE (Cumulated Dissipated Energy and EFU (Estimated Fluid Usage). It has also been shown that a lower CDE provides obvious benefits: less endothelium cells damages and lower complication rates (Mady MA et al., Clin.Ophthalmol. 2012; 6:503-10).

The latest technologies, i.e. the Active Sentry Handpiece and Hybrid tips, have been introduced to further improve the safety of phacoemulsification. The Active Sentry system has moved pressure sensors closer to the operated eye, hence further reducing the risk of surge during procedures. (Thorne A et al. Phacoemulsifier occlusion break surge volume reduction, J Cataract Refract Surg. 2018;44:1491-1496). The Hybrid tips have been designed to prevent posterior capsule rupture in the event of contact with the capsule.

This new technology allows phacoemulsification procedures under reduced infusion pressures and a "high-vacuum - low energy" strategy which may lead to a safer procedure.

Data from this study will try to demonstrate that cataract surgeries with Active Sentry will need less CDE and therefore may be safer, due to the surge effects decrease. This CDE parameter will be analysed according to differents subgroups: Presence of hybrid tip or balanced tip, cataract score based on the WHO nuclear grading recommendation (Thylefors B et al., (2002) The WHO Cataract Grading Group, Ophthalmic Epidemiology, 9:2, 83-95) The recent experiences conducted in real world condition in different sites have suggested that Centurion with AS was able to improved settings: maximum vacuum and UltraSound (US) time reduction and as a consequence a 20 to 30% CDE reduction.


title: Study of the Immunological and Virological Response of Patients Infected With SARS-CoV-2 and Presenting an Asymptomatic or Pauci-symptomatic Form

acronym: AMBUCOV

summary:
The purpose of this study is to describe the immunological and virological response of patients infected with CoV-2-SARS and presenting an asymptomatic or mildly symptomatic form, in particular the innate and adaptive response as well as the virological clearance kinetics.

The research hypothesis is that patients with an ambulatory form of SARS-CoV-2 infection, whether asymptomatic or mildly symptomatic, are able to mount an innate and adaptive immunological response capable of rapidly clearing the virus, in contrast to severe forms in which an early deficit of type 1 IFN response has been demonstrated, possibly responsible for a defect in the control of viral replication in the blood.

primary_purpose: Diagnostic

ReferenceCitation: Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.

name: From the NHC Key Laboratory of Biosafety, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (N.Z., W.W., J.S., X.Z., B.H., R.L., P.N., X.M., D.W., W.X., G.W., G.F.G., W.T.), and the Department of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (X.L.) — both in Beijing; Wuhan Jinyintan Hospital (D.Z.), the Division for Viral Disease Detection, Hubei Provincial Center for Disease Control and Prevention (B.Y., F.Z.), and...

family: Zhu

full_name: Na Zhu

family: Zhang

full_name: Dingyu Zhang

given: Dingyu

family: Wang

full_name: Wenling Wang

given: Wenling

family: Li

full_name: Xingwang Li

given: Xingwang

family: Yang

full_name: Bo Yang

given: Bo

family: Song

full_name: Jingdong Song

given: Jingdong

family: Zhao

full_name: Xiang Zhao

given: Xiang

family: Huang

full_name: Baoying Huang

given: Baoying

family: Shi

full_name: Weifeng Shi

given: Weifeng

family: Lu

full_name: Roujian Lu

given: Roujian

family: Niu

full_name: Peihua Niu

given: Peihua

family: Zhan

full_name: Faxian Zhan

given: Faxian

family: Ma

full_name: Xuejun Ma

given: Xuejun

full_name: Dayan Wang

given: Dayan

family: Xu

full_name: Wenbo Xu

given: Wenbo

family: Wu

full_name: Guizhen Wu

given: Guizhen

family: Gao

full_name: George F. Gao

given: George F.

family: Tan

full_name: Wenjie Tan

given: Wenjie

journal_name: New England Journal of Medicine

oa_colors: green other

evidence: open (via free article)

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

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

ReferenceCitation: Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum in: Lancet Respir Med. 2020 Apr;8(4):e26.

ReferenceCitation: Hadjadj J, Yatim N, Barnabei L, Corneau A, Boussier J, Smith N, Péré H, Charbit B, Bondet V, Chenevier-Gobeaux C, Breillat P, Carlier N, Gauzit R, Morbieu C, Pène F, Marin N, Roche N, Szwebel TA, Merkling SH, Treluyer JM, Veyer D, Mouthon L, Blanc C, Tharaux PL, Rozenberg F, Fischer A, Duffy D, Rieux-Laucat F, Kernéis S, Terrier B. Impaired type I interferon activity and inflammatory responses in severe COVID-19 patients. Science. 2020 Aug 7;369(6504):718-724. doi: 10.1126/science.abc6027. Epub 2020 Jul 13.

ReferenceCitation: Lucas C, Wong P, Klein J, Castro TBR, Silva J, Sundaram M, Ellingson MK, Mao T, Oh JE, Israelow B, Takahashi T, Tokuyama M, Lu P, Venkataraman A, Park A, Mohanty S, Wang H, Wyllie AL, Vogels CBF, Earnest R, Lapidus S, Ott IM, Moore AJ, Muenker MC, Fournier JB, Campbell M, Odio CD, Casanovas-Massana A; Yale IMPACT Team, Herbst R, Shaw AC, Medzhitov R, Schulz WL, Grubaugh ND, Dela Cruz C, Farhadian S, Ko AI, Omer SB, Iwasaki A. Longitudinal analyses reveal immunological misfiring in severe COVID-19. Nature. 2020 Aug;584(7821):463-469. doi: 10.1038/s41586-020-2588-y. Epub 2020 Jul 27.


title: Study of the Robustness Predictive Factors in People Aged Over 75 Years After Going to the Emergency Room

acronym: ROB-U

summary: After emergency room visits, the elderly patients can increase their dependence and functional decline. In this context the goal of this study is to demonstrate that there are robustness predictive factors after visit to the emergency room.

lead_sponsor: Lille Catholic University


title: A Pilot Study of Proprioception Stimulation by Repeated Multi-site Tendon Vibrations, on Upper Limb Motor Skills Recovery After Recent Stroke

acronym: VIBRAMOT

summary:
Stroke is the leading cause of severe acquired disabilities in adults. It can affect sensory and motor functions which are closely entangled. Among them, upper limb function is often strongly impaired. In this study the investigators are interested in the eventuality to improve motor recovery by the mean of stimulating the proprioception.

Proprioception can be stimulated by tendinous vibrations in order to act on the neuromuscular system through the vibratory tonic reflex and by movement illusion.

Stimulation by tendinous vibrations, applied to the musculotendinous endings, has been already proposed in post stroke rehabilitation, but only at late stages. Thus the aim of our study is to observe the effects of repeated tendon vibrations, applied in the early post stroke phase, the effect being measured on the excitability of the motor cortex by the Motor Evoked Potentials and on the motor recovery (motor control and activities).

ReferenceCitation: Reinkensmeyer DJ, Boninger ML. Technologies and combination therapies for enhancing movement training for people with a disability. J Neuroeng Rehabil. 2012 Mar 30;9:17. doi: 10.1186/1743-0003-9-17.

family: Reinkensmeyer

full_name: David J Reinkensmeyer

given: David J

family: Boninger

full_name: Michael L Boninger

given: Michael L

currency_apc_doaj: GBP

journal_name: Journal of NeuroEngineering and Rehabilitation

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: University of California - eScholarship University of California

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Kitago T, Krakauer JW. Motor learning principles for neurorehabilitation. Handb Clin Neurol. 2013;110:93-103. doi: 10.1016/B978-0-444-52901-5.00008-3. Review.

family: Kitago

full_name: Tomoko Kitago

given: Tomoko

family: Krakauer

full_name: John W. Krakauer

given: John W.

genre: book-chapter

genre_raw: book-chapter

journal_name: Handbook of Clinical Neurology

publisher: Elsevier

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Nudo RJ, McNeal D. Plasticity of cerebral functions. Handb Clin Neurol. 2013;110:13-21. doi: 10.1016/B978-0-444-52901-5.00002-2. Review.

family: Nudo

full_name: Randolph J. Nudo

given: Randolph J.

family: McNeal

full_name: David McNeal

given: David

title: Plasticity of cerebral functions

ReferenceCitation: Edin BB, Johansson N. Skin strain patterns provide kinaesthetic information to the human central nervous system. J Physiol. 1995 Aug 15;487(1):243-51.

ReferenceCitation: Hagbarth KE, Eklund G. The muscle vibrator--a useful tool in neurological therapeutic work. Scand J Rehabil Med. 1969;1(1):26-34.

ReferenceCitation: Goodwin GM, McCloskey DI, Matthews PB. Proprioceptive illusions induced by muscle vibration: contribution by muscle spindles to perception? Science. 1972 Mar 24;175(4028):1382-4.

ReferenceCitation: Roll JP, Vedel JP. Kinaesthetic role of muscle afferents in man, studied by tendon vibration and microneurography. Exp Brain Res. 1982;47(2):177-90.

ReferenceCitation: Roll JP, Albert F, Thyrion C, Ribot-Ciscar E, Bergenheim M, Mattei B. Inducing any virtual two-dimensional movement in humans by applying muscle tendon vibration. J Neurophysiol. 2009 Feb;101(2):816-23. doi: 10.1152/jn.91075.2008. Epub 2008 Dec 3.

family: Roll

full_name: Jean-Pierre Roll

given: Jean-Pierre

family: Albert

full_name: Frédéric Albert

given: Frédéric

family: Thyrion

full_name: Chloé Thyrion

title: Inducing Any Virtual Two-Dimensional Movement in Humans by Applying Muscle Tendon Vibration

ReferenceCitation: Heath CJ, Hore J, Phillips CG. Inputs from low threshold muscle and cutaneous afferents of hand and forearm to areas 3a and 3b of baboon's cerebral cortex. J Physiol. 1976 May;257(1):199-227.

ReferenceCitation: Forner-Cordero A, Steyvers M, Levin O, Alaerts K, Swinnen SP. Changes in corticomotor excitability following prolonged muscle tendon vibration. Behav Brain Res. 2008 Jun 26;190(1):41-9. doi: 10.1016/j.bbr.2008.02.019. Epub 2008 Feb 20.

ReferenceCitation: Marconi B, Filippi GM, Koch G, Pecchioli C, Salerno S, Don R, Camerota F, Saraceni VM, Caltagirone C. Long-term effects on motor cortical excitability induced by repeated muscle vibration during contraction in healthy subjects. J Neurol Sci. 2008 Dec 15;275(1-2):51-9. doi: 10.1016/j.jns.2008.07.025. Epub 2008 Aug 29.

ReferenceCitation: Rosenkranz K, Rothwell JC. The effect of sensory input and attention on the sensorimotor organization of the hand area of the human motor cortex. J Physiol. 2004 Nov 15;561(Pt 1):307-20. Epub 2004 Sep 23.

ReferenceCitation: Noma T, Matsumoto S, Shimodozono M, Etoh S, Kawahira K. Anti-spastic effects of the direct application of vibratory stimuli to the spastic muscles of hemiplegic limbs in post-stroke patients: a proof-of-principle study. J Rehabil Med. 2012 Apr;44(4):325-30. doi: 10.2340/16501977-0946.

title: Anti-spastic effects of the direct application of vibratory stimuli to the spastic muscles of hemiplegic limbs in post-stroke patients: A proof-of-principle study

ReferenceCitation: Celnik P, Hummel F, Harris-Love M, Wolk R, Cohen LG. Somatosensory stimulation enhances the effects of training functional hand tasks in patients with chronic stroke. Arch Phys Med Rehabil. 2007 Nov;88(11):1369-76.

ReferenceCitation: Liepert J, Binder C. Vibration-induced effects in stroke patients with spastic hemiparesis--a pilot study. Restor Neurol Neurosci. 2010;28(6):729-35. doi: 10.3233/RNN-2010-0541.

name: Department of Neurorehabilitation, Kliniken Schmieder, Allensbach, Germany

title: Vibration-induced effects in stroke patients with spastic hemiparesis – a pilot study

ReferenceCitation: Tavernese E, Paoloni M, Mangone M, Mandic V, Sale P, Franceschini M, Santilli V. Segmental muscle vibration improves reaching movement in patients with chronic stroke. A randomized controlled trial. NeuroRehabilitation. 2013;32(3):591-9. doi: 10.3233/NRE-130881.

name: Biomechanics and Movement Analysis Laboratory, Azienda Policlinico Umberto I, Rome, Italy

name: Department of Physical Medicine and Rehabilitation, Sapienza – University of Rome, Rome, Italy

name: Casa di Cura “Villa Fulvia”, Rome, Italy

ReferenceCitation: Marconi B, Filippi GM, Koch G, Giacobbe V, Pecchioli C, Versace V, Camerota F, Saraceni VM, Caltagirone C. Long-term effects on cortical excitability and motor recovery induced by repeated muscle vibration in chronic stroke patients. Neurorehabil Neural Repair. 2011 Jan;25(1):48-60. doi: 10.1177/1545968310376757. Epub 2010 Sep 12.

name: IRCCS Santa Lucia Foundation, Rome, Italy

name: Catholic University of Rome, Rome, Italy

name: Tor Vergata University of Rome, Rome, Italy

name: “La Sapienza” University of Rome, Rome, Italy

title: Long-Term Effects on Cortical Excitability and Motor Recovery Induced by Repeated Muscle Vibration in Chronic Stroke Patients

ReferenceCitation: Conrad MO, Gadhoke B, Scheidt RA, Schmit BD. Effect of Tendon Vibration on Hemiparetic Arm Stability in Unstable Workspaces. PLoS One. 2015 Dec 3;10(12):e0144377. doi: 10.1371/journal.pone.0144377. eCollection 2015.

ReferenceCitation: Ribot-Ciscar E, Butler JE, Thomas CK. Facilitation of triceps brachii muscle contraction by tendon vibration after chronic cervical spinal cord injury. J Appl Physiol (1985). 2003 Jun;94(6):2358-67. Epub 2003 Feb 14.

ReferenceCitation: Kawahira K, Higashihara K, Matsumoto S, Shimodozono M, Etoh S, Tanaka N, Sueyoshi Y. New functional vibratory stimulation device for extremities in patients with stroke. Int J Rehabil Res. 2004 Dec;27(4):335-7.

ReferenceCitation: Field-Fote E, Ness LL, Ionno M. Vibration elicits involuntary, step-like behavior in individuals with spinal cord injury. Neurorehabil Neural Repair. 2012 Sep;26(7):861-9. doi: 10.1177/1545968311433603. Epub 2012 Feb 9.

name: University of Miami Miller School of Medicine, Miami, FL, USA

name: University of Miami Miller School of Medicine, Coral Gables, FL, USA

title: Vibration Elicits Involuntary, Step-Like Behavior in Individuals With Spinal Cord Injury

ReferenceCitation: Schindler I, Kerkhoff G, Karnath HO, Keller I, Goldenberg G. Neck muscle vibration induces lasting recovery in spatial neglect. J Neurol Neurosurg Psychiatry. 2002 Oct;73(4):412-9.

ReferenceCitation: Kamada K, Shimodozono M, Hamada H, Kawahira K. Effects of 5 minutes of neck-muscle vibration immediately before occupational therapy on unilateral spatial neglect. Disabil Rehabil. 2011;33(23-24):2322-8. doi: 10.3109/09638288.2011.570411. Epub 2011 Apr 12.

ReferenceCitation: Murillo N, Valls-Sole J, Vidal J, Opisso E, Medina J, Kumru H. Focal vibration in neurorehabilitation. Eur J Phys Rehabil Med. 2014 Apr;50(2):231-42. Review.

location_facility: Physical and Rehabilitation Medicine department of Hôpital Fernand Widal


type: Registry Identifier

title: Use of Multispectral Imaging in Digestive Inflammation Diagnosis

acronym: ENDOSPECTRALE

summary:
The study aims as principal objective to show the association between reflectance intensity of mucosa at different wave lengths and

the presence of acute or chronic inflammation in stomach or rectum and normal mucosa;
the presence of glandular atrophy in stomach or intestinal metaplasia.

The secondary objectives are:

to identify reflectance profile which characterize an acute or a chronic inflammation, a glandular atrophy or an intestinal metaplasia, respectively;
to find a correlation between the reflectance to different frequencies and intensity of inflammation according to Sydney Classification in stomach (Dixon M F 1994) and in rectum (Erben U 2014).

location_facility: Service Hépato-Gastroentérologie, Hôpital Ambroise Paré


title: Impact of Bariatric Surgery in Obese Patients With and Without Obstructive Sleep Apnea Syndrome - COLOSS

acronym: COLOSS

summary: It has been shown to date that obesity is associated with increased mortality and that weight loss significantly improves cardiovascular risk factors. Among patients receiving bariatric surgery, 30-90% have moderate to severe obstructive sleep apnea (OSA) syndrome. Given the strong associations between OSA and cardiometabolic comorbidities, this project is based on the hypothesis of a lower improvement of cardiovascular risk factors and a higher number of post-surgical complications in OSAS patients.

ipd_sharing: Undecided

intervention_type: Procedure


title: A Controlled Randomized, Open Label, Multicenter, Non-inferiority Trial Evaluating an Individualized Antibiotic Duration Treatment Based on Patient Clinical Response, Evaluated Through Connected Devices, for Community Acquired Pneumonia in the Community Setting

acronym: AIR

summary:
Primary aim: to demonstrate that stopping antibiotic treatment in patients diagnosed with acute community acquired pneumonia (CAP) based on clinical response has a non-inferior efficacy 15 days after start of treatment, compared to a conventional predetermined duration left to the physician's judgement, in adults treated in the community setting.

Secondary aims: To compare the 2 study arms on:

Clinical success at late follow up (Day 30),
Duration of antibiotic treatment,
Frequency and severity of adverse events,
Patient's pneumonia symptoms and quality of life.

location_facility: Unité des Maladies Infectieuses, CHU Raymond Poincaré

intervention_type: Drug


title: A Phase III, Multinational, Multicenter, Investigator-Masked, Randomised, Active-Controlled Trial, Comparing the Efficacy and Safety of DE-130A With Xalatan® in Patients With Open-Angle Glaucoma or Ocular Hypertension

summary: A Phase III, Multinational, Multicenter, Investigator-Masked, Randomised, Active-Controlled Trial, comparing the efficacy and safety of DE-130A with Xalatan® in Patients with Open-Angle Glaucoma or Ocular Hypertension over a 3-Month period, followed by a 12-Month Follow-Up with Open-Label DE-130A Treatment

lead_sponsor: Santen SAS


title: Home-based Cycling Using Connected Ergometric Bicycles for People With Lumbar Spinal Stenosis: a Randomized Controlled Trial

acronym: FLEXCAL

summary: The main objective of the study is to compare the efficacy on back-specific activity limitations at 4 months after-randomisation of home-based cycling using connected ergometric bicycles associated with usual care to usual care.

ReferenceCitation: Nguyen C, Boutron I, Roren A, Baron G, Pauwels C, Lefèvre-Colau MM, Poiraudeau S, Dupeyron A, Coudeyre E, Rannou F. Home-based cycling using connected ergometric bicycles for people with lumbar spinal stenosis (FLEXCAL): Protocol for a randomised trial. Ann Phys Rehabil Med. 2021 Mar;64(2):101351. doi: 10.1016/j.rehab.2019.12.006. Epub 2020 Jan 23.

location_facility: Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin


title: Determinant of the Risk of the Becoming Frail in the Non-dependent Elederly

acronym: DEPART

summary: As an active and healthy ageing, "Successful Ageing" is a societal challenge for all countries members according to the European Commission. This study is intended to contribute to increase healthy, active and non-dependent lifetime. To this end the main goal is to highlight clinical and biological frailty determinants in elderly with potential weaknesses.


title: Dose Reduction and Acquisition Parameters Optimization for PEDiatric Digital Radiography

acronym: DRAPOPED

summary: To reduce "As Low As Diagnostically Acceptable" (ALADA) the X ray exposure of pediatric radiology by using a new post treatment processing algorithm (S-Vue, Samsung table GC85A).

time_perspective: Retrospective

location_facility: Service de Radiologie Pédiatrique, C.H.U. Bicêtre, APHP


title: Impact of a Pharmacist's Intervention on Knowledge and Adherence to Biologic Disease-modifying Drugs in Patients With Spondyloarthritis: a Randomised Controlled Trial.

acronym: SPADHESION

summary:
There is a lack of knowledge among patients concerning their treatment with bDMARDs, which could lead to low adherence.

The objective of this study is to assess the impact of a pharmacist's intervention on the adherence to bDMARDs in patients with Spondyloarthritis.

primary_purpose: Other

lead_sponsor: Dr Ornella Conort


title: Impacts on Health Outcomes and Resources Utilization of Hospital-at-home for Elderly Patients With Multiple Myeloma

summary:
The study aims to compare the overall survival adjusted to quality of life of 2 groups of patients with multiple myeloma, depending on the type of care: (1) day hospitalization exclusively or (2) day hospitalization combined with hospital-at-home.

As secondary objectives, the study aims to compare the impacts of the two types of care organization on:

the survival of patients and response to treatments according to criteria of the International Myeloma Working Group,
psychological status of patients,
specific toxicity related to treatment used (haematological and infectious toxicity, neurotoxicity, ...),
health outcomes,
the caregiver's burden,

This study is combined with a qualitative study about the incentives and the barriers, and in order to set up the patient's typology.


title: Endocrine and Absorptive Intestinal Function in Patients at Two Years of Bariatric Surgery: Omega Loop Gastric Bypass Versus Roux-en-Y Gastric Bypass

acronym: MINIBHO

summary:
Gastric bypass with omega loop technic (OLGB) seems to be as effective as gastric bypass roux-en-Y (RYGB the reference) for the management of obesity and type 2 diabetes, but with less early surgical complications and more undernutrition in long terms.

This study aims to explore the profile of secretion of entero-insular hormone after a meal test in OLGB patient vs RYGB to understand the mechanisms of the improvement of type 2 diabetes after OLGB.

Secondary objectives are to better understand the absorptive function of the gut after a gastric bypass, to understand why is there more undernutrition in long term after OLGB than after RYGB.

time_perspective: Cross-Sectional

location_facility: AP-HP - Hôpital Européen Georges-Pompidou

intervention_type: Biological


type: EudraCT Number

title: Potentiation of Cisplatin-based Chemotherapy by Digoxin in Advanced Unresectable Head and Neck Cancer Patients

acronym: DIGHANC

summary:
Introduction: Patients with primary unresectable advanced head and neck squamous cell carcinomas (HNSCC) have a poor prognosis with a median survival of 22 months (Hauswald H Radiat Oncol 2011). They are usually treated with induction chemotherapy followed by radiochemotherapy or platinum-based concomitant radiochemotherapy. Most patients achieve an objective clinical response contrasting with a high rate of local recurrence and distant metastases in the year following radiochemotherapy (Argiris A Ann Oncol 2011). Improvement of the efficacy of chemotherapy remains therefore a major clinical goal for this group of patients. During the past years, the investigators demonstrated that some conventional chemotherapeutics (anthracycline, oxaliplatin…) induce a type of "immunogenic" cell death (ICD) characterized by the exposure of calreticulin on the tumor cell surface, the secretion of ATP and the release of high-mobility group box 1 (HMGB1) resulting in activation of tumor immunity (Galluzzi L Nat Rev Drug Discov 2012). The investigators recently showed that the Na/K-ATPase inhibitor, digoxin, favors ICD, when combined with cisplatin, a drug known not to induce ICD. In preclinical models, a synergy between cisplatin and digoxin which led to a significant therapeutic improvement (Menger L Sci Transl Med 2012) has been observed. This effect seems to be mediated by the immune system as the combined therapy induced intratumor T cell infiltration producing cytokines (Menger L Sci Transl Med 2012).

Hypothesis: Based on our preclinical data, the hypothesis is that adding digoxin to the conventional cisplatin based induction chemotherapy regimen in unresectable advanced HNSCC will increase the efficacy of this therapy via the induction of anti-tumor immunity.

Objectives:

Main: the primary objective is to assess the clinical and biological safety of the combination of digoxin to cisplatin-based chemotherapy.

Secondary: The secondary objectives are to investigate biological markers of efficacy by analyzing the recruitment of functional T cells in tumour biopsies after treatment with the combination of digoxin and chemotherapy.


title: Pilot Study to Evaluate the Effectiveness of Somatosensory Rehabilitation of Pain by Vibrotactile Stimulation on Static Mechanical Allodynia of Less Than Three Months Duration

acronym: RESISTAL

summary: This study aims to demonstrate that somatosensory rehabilitation of pain associated with static mechanical allodynia has superior efficacy over placebo treatment as well as over spontaneous changes.

lead_sponsor: CRRF La Châtaigneraie


title: Prospective Cohort Study: Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia

acronym: GASTRIMED

summary:
This prospective cohort study aims to assess the incidence of gastric cancer in patients with intestinal metaplasia in body of stomach or angular incisure.

As secondary objectives, among the patients included in the cohort, the study will:

assess the incidence of low grade dysplasia,
assess the incidence of high grade dysplasia in patients with low grade dysplasia,
identify risk factors of progression to dysplasia and gastric cancer.

location_facility: Service Hépato-gastro-Entérologie, Hôpital Ambroise Paré


title: Evaluation of the Impact of Within-hospital Trajectories of Patients Admitted in Intensive Care Units (ICU) From Emergency Departments

acronym: SUREA

summary:
This multicenter cohort aims to assess the impact of within-hospital trajectories of patients admitted in intensive care units from emergency departments on vital prognosis of patients, duration of hospital stay and hospital costs.

As secondary objectives, the study will:

assess the impact of clinical and demographic characteristics on hospital trajectories of patients.
assess the impact of emergency units workload, beds availability in medical units and in intensive care units, and global hospital organisation on patients care trajectories.

location_facility: Emergency Department, Bichat-Claude Bernard Hospital


title: A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome

summary: A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome


title: Phase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents

summary: Long term survival can now be achieved in 75% of cases of pediatric cancers. However, some types of tumors (ie CNS tumors) or advanced stages (metastatic sarcomas/neuroblastomas) cannot be cured by any treatment. Thus, evaluation of new drugs or combinations are strongly needed. The recommended doses have been defined in children for TMZ (200 mg/m2/d x 5 d) and TPT (1.5 mg/m2/d x 5 d). Some preclinical and clinical studies have shown activity of both drugs in some pediatric cancers. Nevertheless, the association of the two drugs has never been evaluated. The study aims to determine Maximum Tolerated Dose and dose limiting toxicities of each drug when associated and to assess efficacy of the combination.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Impact of Deprivation on Hospital Care Efficiency in Paediatrics

acronym: PRECAPED

summary:
Many studies have shown that deprived patients consumed more healthcare resources than non-deprived patients, in particular in terms of increased length of stay (LOS) and readmission rates, which has an impact on hospital efficiency and the healthcare system as a whole. There are many types of indicators available to assess deprivation in a hospital setting and French decision makers are currently using reliance on public aids to allocate additional funding to hospitals, based on the percentage of deprived patients they admit. However there are limits to this method: it only assesses one dimension of deprivation, the target population often does not know about the existence of those aids, and they have a clear threshold effect. An alternative solution is to use ecological deprivation indices which are obtained by aggregating different variables measured at a specific time and place, i.e. the patient's place of residence at the time of care. One such index, the FDep , was developed specifically in France, although others such as the Carstairs index and the European deprivation index also exist.

The primary objective of this study is to study the association between deprivation, measured by the FDep, and hospital care efficiency in paediatric and neonatology patients, measured by the difference between patient LOS and the national average LOS of their diagnosis-related group, DRG). The secondary objectives are to carry out a budget impact analysis on the impact of deprivation for hospitals with a paediatric or neonatology ward, to study the association between deprivation and readmission at 15 days, to study the relation between FDep and the currently used deprivation indicators, and to assess the added value of the FDep compared to those indicators and whether or not it should be used in routine practice.

In order to do so, an exhaustive retrospective study using the French hospital claims database will be carried out for the years 2012-2014. Deprivation indices will be calculated based on patients' postcode. The primary endpoint will be calculated using the national LOS present in the French national cost study. Similarly, the budget impact will look at the difference between production costs derived from the national cost study after adjusting for LOS and the statutory health insurance's tariffs, which will allow us to assess whether a hospital stay is associated with a gain, a loss or is budget-neutral for the hospital. Readmissions at 15 days will be identified through record linkage.

Descriptive analyses will summarise both hospital and patient characteristics. Uni- and bivariate analyses will be carried out by focusing of the variables of interest (e.g. average deprivation index by legal status of the hospital, mean LOS depending on the number of paediatric beds etc.). The deprivation index will be divided into quantiles as is the norm and the endpoints will be assessed for each of those quantiles. An ANOVA (or a Kruskal-Wallis test if the ANOVA hypotheses are not met) will test whether the results differ between each quantile. For readmission rates, a Chi² test will be performed.

In order to study the association between deprivation and the endpoints, the investigators will model each endpoint using as the main explanatory variable the deprivation index. Three main types of explanatory variables will be added to the model: patient characteristics (age, sex, severity level etc.), hospital characteristics (legal status, size, number of full-time equivalent etc.) and environment/context characteristics (number of paediatricians for 1,000 inhabitants, rural vs. urban area etc.).

In order to assess the added benefit of using the deprivation index vs. the current indicators, a sub-cohort will be constructed in Paris teaching hospitals (AP-HP) as unfortunately, whether the patient receives public aids is not present in the hospital claim database but is available only at the local level. The investigators will look at the distribution of patients with public aids in each quantile of the deprivation index and run the previous models using the two types of indicators one after the other and comparing the statistical performance of each pair of models.


title: Clinical Course and Changes in the Respiratory Microbiota Based on Antibiotic Treatment in Patients With Cystic Fibrosis

summary:
Bronchopulmonary infection is the most common and serious complication in the evolutionary course of cystic fibrosis (CF). Administration of antibiotics adapted to infecting pathogens is one of the key issues for its management. However, more than half of patients with CF have chronic respiratory infections for which infectious agent remains unknown leading to empirical antibiotic therapies that are not adapted to the causative agents. Recently, new technologies have been applied for the description and characterization of microbial agents in CF patients including molecular biology techniques that allowed us to detect and to identify new and/or emerging pathogens. Moreover, more sophisticated molecular techniques such as pyrosequencing and PCR amplification and cloning lead us to demonstrate the huge microbial diversity associated with chronic bronchopulmonary infections in this population. Otherwise, a metagenomic approach revealed the extraordinary complexity of the respiratory flora in these patients and, somewhat unexpected, abundance of anaerobes, viruses, and bacteriophages. In addition, it has been shown that some antibiotics commonly used in clinical practice for the treatment of respiratory infections were able to induce these bacteriophages, suggesting the existence of lateral gene transfer by transduction. The human microbiome is the set of microbial communities associated with the human body and represents all living microorganisms in the body. Its role in the immunity development has recently been demonstrated suggesting that changes in this ecosystem play a critical role in evolution of several human diseases. For example, in obesity it has been shown that there is a relationship between the intestinal human microbiota and nutritional and metabolic status of the hosts and specific alterations of these intestinal microbiota may represent a metagenomic signature of this disease. Evolution of the respiratory microbiota in patients with cystic fibrosis, whose nutritional status is often impaired (chronic malnutrition due to disorder of digestive absorption) and receiving regular antibiotic treatments remains unknown to date. Characterization of this ecosystem and its role is a critical step to understand the evolutionary course of the disease.

The main objective of this seminal study is to describe and to characterize the respiratory microbiota from sputum samples obtained from a limited number of selected patients with CF from 5 regional care centers (CRCM) from South of France (Mucomed network) (2 patients per center : 6 adults and 4 children), with similar clinical, microbiological and functional status before and after a cure of antibiotics. Different microbiological tools will be used including axenic culture systems, co-culture on amoebae in order to to isolate and to identify the microbial communities. Identification of bacteria will be done using MALDI-TOF mass spectrometry and/or molecular techniques. Moreover, 16S rRNA PCR amplification followed by cloning and sequencing of PCR products from the same sputum sample will be carried out to identify and to compare the bacterial species identified using molecular methods. In a second step, once the respiratory microbiota was characterized, it will be interesting to develop a dedicated microarray that will allow to detect all the bacteria identified in the first stage of the project and to assess its relevance on a larger cohort of patients with CF by studying the correlation between the respiratory microbiota and clinical status of patients according to the prescribed antibiotic treatments.

This study will open new clinical perspectives and will help us to determine the potential role of antibiotics on the microbiota evolution during treatment according to regional health care practices. This will contribute to better understand the role of the microbiota in the evolution of these chronic respiratory infections. It could be the first step for innovative therapeutic strategies, taking into account the balance of complex microbial flora and possibly evolving according to antibiotic therapies. It could also form part of a larger preventive strategy against transmission of specific pathogens in CF.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


ReferenceCitation: Lucey MR, Mathurin P, Morgan TR. Alcoholic hepatitis. N Engl J Med. 2009 Jun 25;360(26):2758-69. doi: 10.1056/NEJMra0805786. Review.

family: Lucey

full_name: Michael R. Lucey

given: Michael R.

family: Mathurin

full_name: Philippe Mathurin

given: Philippe

family: Morgan

full_name: Timothy R. Morgan

given: Timothy R.

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Alcoholic Hepatitis

ReferenceCitation: Louvet A, Wartel F, Castel H, Dharancy S, Hollebecque A, Canva-Delcambre V, Deltenre P, Mathurin P. Infection in patients with severe alcoholic hepatitis treated with steroids: early response to therapy is the key factor. Gastroenterology. 2009 Aug;137(2):541-8. doi: 10.1053/j.gastro.2009.04.062. Epub 2009 May 13.

family: Louvet

full_name: Alexandre Louvet

given: Alexandre

family: Wartel

full_name: Faustine Wartel

given: Faustine

family: Castel

full_name: Hélène Castel

given: Hélène

family: Dharancy

full_name: Sébastien Dharancy

given: Sébastien

family: Hollebecque

full_name: Antoine Hollebecque

given: Antoine

family: Canva–Delcambre

full_name: Valérie Canva–Delcambre

given: Valérie

family: Deltenre

full_name: Pierre Deltenre

given: Pierre

journal_name: Gastroenterology

publisher: Elsevier BV

title: Infection in Patients With Severe Alcoholic Hepatitis Treated With Steroids: Early Response to Therapy Is the Key Factor

ReferenceCitation: Louvet A, Naveau S, Abdelnour M, Ramond MJ, Diaz E, Fartoux L, Dharancy S, Texier F, Hollebecque A, Serfaty L, Boleslawski E, Deltenre P, Canva V, Pruvot FR, Mathurin P. The Lille model: a new tool for therapeutic strategy in patients with severe alcoholic hepatitis treated with steroids. Hepatology. 2007 Jun;45(6):1348-54.

ReferenceCitation: Mathurin P. Corticosteroids for alcoholic hepatitis--what's next? J Hepatol. 2005 Sep;43(3):526-33. Review.

ReferenceCitation: Naveau S, Chollet-Martin S, Dharancy S, Mathurin P, Jouet P, Piquet MA, Davion T, Oberti F, Broët P, Emilie D; Foie-Alcool group of the Association Française pour l'Etude du Foie. A double-blind randomized controlled trial of infliximab associated with prednisolone in acute alcoholic hepatitis. Hepatology. 2004 May;39(5):1390-7.

ReferenceCitation: Mathurin P, Abdelnour M, Ramond MJ, Carbonell N, Fartoux L, Serfaty L, Valla D, Poupon R, Chaput JC, Naveau S. Early change in bilirubin levels is an important prognostic factor in severe alcoholic hepatitis treated with prednisolone. Hepatology. 2003 Dec;38(6):1363-9.

ReferenceCitation: Mathurin P, Mendenhall CL, Carithers RL Jr, Ramond MJ, Maddrey WC, Garstide P, Rueff B, Naveau S, Chaput JC, Poynard T. Corticosteroids improve short-term survival in patients with severe alcoholic hepatitis (AH): individual data analysis of the last three randomized placebo controlled double blind trials of corticosteroids in severe AH. J Hepatol. 2002 Apr;36(4):480-7.

ReferenceCitation: Mathurin P, Duchatelle V, Ramond MJ, Degott C, Bedossa P, Erlinger S, Benhamou JP, Chaput JC, Rueff B, Poynard T. Survival and prognostic factors in patients with severe alcoholic hepatitis treated with prednisolone. Gastroenterology. 1996 Jun;110(6):1847-53.

ReferenceCitation: Ramond MJ, Poynard T, Rueff B, Mathurin P, Théodore C, Chaput JC, Benhamou JP. A randomized trial of prednisolone in patients with severe alcoholic hepatitis. N Engl J Med. 1992 Feb 20;326(8):507-12.

ReferenceCitation: Mathurin P, Louvet A, Duhamel A, Nahon P, Carbonell N, Boursier J, Anty R, Diaz E, Thabut D, Moirand R, Lebrec D, Moreno C, Talbodec N, Paupard T, Naveau S, Silvain C, Pageaux GP, Sobesky R, Canva-Delcambre V, Dharancy S, Salleron J, Dao T. Prednisolone with vs without pentoxifylline and survival of patients with severe alcoholic hepatitis: a randomized clinical trial. JAMA. 2013 Sep 11;310(10):1033-41. doi: 10.1001/jama.2013.276300.

family: Duhamel

full_name: Alain Duhamel

given: Alain

family: Nahon

full_name: Pierre Nahon

family: Carbonell

full_name: Nicolas Carbonell

given: Nicolas

family: Boursier

full_name: Jérôme Boursier

given: Jérôme

family: Anty

full_name: Rodolphe Anty

given: Rodolphe

title: Prednisolone With vs Without Pentoxifylline and Survival of Patients With Severe Alcoholic Hepatitis

location_facility: Hospital Antoine Béclère (Assistance Publique des Hôpiaux de Paris)

title: Evaluation of the Survival Benefit of the Adjunction of Pentoxifylline to Corticosteroids in Patients Suffering From Severe Alcoholic Hepatitis

summary: The treatment of severe forms of alcoholic hepatitis (AH) constitutes a major challenge for clinicians involved in the management of severe alcoholic liver disease. In patients with Maddrey function higher than 32, compelling evidence from data has shown that corticosteroids improve short-term survival. However, novel strategies or molecules are required in light of the fact that approximately 40 % of patients continue to die at 6 months. A double-blinded randomized controlled trial of 101 patients has showed that Pentoxifylline improves survival of patients with severe AH, as compared to placebo. In terms of mechanisms, the effect of pentoxifylline is related to prevention of hepatorenal function whereas corticosteroids induce an early improvement in liver function. When considering these differences of mechanisms, many clinicians suggest that the addition of pentoxyfilline to corticosteroids is an attractive option that needs to be tested in patients with severe AH.


title: French National Registry of Congenital Dyserythropoietic Anemia

acronym: CDA

summary:
Congenital dyserythropoietic anemia is a heterogeneous inherited disease. Hyperplasic erythropoiesis is ineffective and associated with morphological abnormalities of some of the erythroblasts that form the basis of cytological classification. The cumulative incidence is not very clear, but varies between countries from 0.08 million in Scandinavia to 2.6 cases/million inhabitants in Italy where it appears to be the most reported.

The common manifestation is moderate chronic congenital anemia. This anaemia is either normocytic or discreetly macrocytic, non-regenerative or inappropriate regarding anaemia, contrasting with signs of hemolysis with moderate unconjugated hyperbilirubinemia. Diagnosis is usually made in the pediatric period, but because of the great heterogeneity, the diagnosis sometimes may be delayed. Splenomegaly and jaundice are mostly present. Secondary hemochromatosis is common in the absence of transfusion due to hyper-intestinal absorption of iron induced by the dyserythropoiesis.

The transmission mode for Type I and II is autosomal recessive, while it is autosomal dominant or sporadic for Type III.

Several clinical questions remain concerning this disease :

the median survival of patients is not well known, neither the causes of death
benefit/risk of splenectomy
iron overload quantification and consequences

The idea is to stablish a French registry of congenital dyserythropoietic anemia in order to help to understand the correlation between phenotype and genotype of this disease.


title: Evaluation of a Preoperative Cognitive Behavioural Therapy (CBT) Program Based on Self-determination Theory for Bariatric Surgery Candidates : an Open-label Controlled, Randomized, Superiority Study

acronym: ACRoBAT

summary: The objective of this study is to evaluate the impact of a pre-surgical intervention program based on Cognitive and Behavioural Emotional Therapies, on the degree of dietary restriction of patients who are candidates for bariatric surgery in order to increase the long-term effectiveness of this kind of surgery

primary_purpose: Supportive Care

location_facility: • Lille Catholic University Hospital Group, Saint Philibert Hospital


title: Influence of Dental Occlusion on the Performance of High Level Rowers (IODPR)

acronym: IODPR

summary: Monocentric, prospective, randomized, open-label, cross-over study.

status: Terminated

lead_sponsor: Rennes University Hospital


title: Feasibility Study on Laparoscopic Double-mesh Sacrocolpopexy With or Without Robotic Assistance, in Female Patients Presenting With Symptomatic Pelvic Organ Prolapse, Based on an Outpatient Treatment Model.

acronym: AMBULAPSE

summary:
Pelvic organ prolapse is an increasingly common functional disorder which affects approximately 30 to 40% of the female population, 12% of whom have a symptomatic form, with a psychological, physical and social impact. Laparoscopic sacrocolpopexy represents the surgical "gold standard" for the treatment of this functional disorder. It aims to suspend the vaginal vault by means of a prosthesis. The patient satisfaction rate is evaluated at 94% with low overall complication rate, evaluated at 11%.

Pelvic organ prolapse surgery is a common, with an estimated 30,000 procedures carried out in France in 2013 (excluding hysterectomy) (2013 ATIH data), and the number will increase in the future due to increasing life expectancy. 13% of women will undergo this type of procedure. The French General Directorate of Health Care Supply (DGOS) deems outpatient surgery to be the benchmark for surgical activity in all eligible patients, and has expressed the need for recommendations and tools for supporting its development. The rate of outpatient surgery for prolapse remains low in France (6.1%, 2015 ATIH data), while it is 25% in the US and 56% in Denmark. The average duration of hospital stays for DRG N81.2 (first degree uterine prolapse) in 2015 was 3.43 days. These procedures have been the subject of publications concerning outpatient care and involving low numbers of patients, with the exception of the publication by Sinhal which involved 111 patients.

ReferenceCitation: Drapier E, De Poncheville L, Dannappel T, Clerc P, Smirnoff A. [Day case laparoscopic sacral colpopexy for genital prolapse]. Prog Urol. 2014 Jan;24(1):51-6. doi: 10.1016/j.purol.2013.07.007. Epub 2013 Aug 13. French.

ReferenceCitation: Bump RC, Norton PA. Epidemiology and natural history of pelvic floor dysfunction. Obstet Gynecol Clin North Am. 1998 Dec;25(4):723-46. Review.

ReferenceCitation: Flam F. Sedation and local anaesthesia for vaginal pelvic floor repair of genital prolapse using mesh. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Dec;18(12):1471-5. Epub 2007 Mar 17.

ReferenceCitation: Cuvelier G. [The ambulatory surgery, source of publications]. Prog Urol. 2013 Jun;23(7):427-9. doi: 10.1016/j.purol.2013.02.007. Epub 2013 Mar 26. French.

family: Cuvelier

full_name: G. Cuvelier

given: G.

journal_name: Progrès en Urologie

title: La chirurgie ambulatoire, source de publications

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Hopital Foch
Ch Lyon Sud
Hopital Antoine Beclere - Aphp
CHU DE Nice - Hôpital l'Archet
Chu de Nantes


acronym: FX-COVID

location_facility: Service de Médecine Intensive Réanimation - CHU Angers

location_facility: Service de Médecine Intensive Réanimation - CHI de Poissy

source: euctr

title: FX06 to Rescue Acute Respiratory Distress Syndrome During Covid-19 Pneumonia

summary:
Vascular leakage following endothelial injury, responsible for interstitial and alveolar edema, is a major feature of pathogen induced acute lung injury. As acute respiratory distress syndrome (ARDS) due to pandemic Covid-19 is associated with more than 60% mortality, controlling vascular leakage may be a major target to decrease the mortality associated with the spreading of the disease in France.

FX06, a drug under clinical development containing fibrin-derived peptide beta15-42, is able to stabilize cell-cell interactions, thereby reducing vascular leak and mortality in several animal models, particularly during lipopolysaccharide-induced and dengue hemorrhagic shock . A phase I study was conducted in humans, with no specific adverse event detected with a dose up to 17.5 mg/kg. In a phase II randomized multicentre double-blinded trial in 234 patients suffering from ST+ acute coronary syndrome, FX06 treated patients exhibited a 58% decrease in the early necrotic core zone. Importantly, adverse events were highly comparable between groups, indicating a high safety profile for the drug . Lastly, the drug was used as a salvage therapy in a patient exhibiting a severe ARDS following EBOLA virus infection . Altogether, those data indicate that FX06 is well tolerated in humans and is a potent regulator of vascular leakage.

Our hypothesis here is that FX06 may decrease pulmonary vascular hyperpermeability during ARDS following SARS-CoV-2 infection, thereby improving gas exchanges and the outcome of infected patients.


title: Randomized Study Estimating the Impact of a Personalized and Remote Support Centered on Exercise and Physical Activity for Patients After Breast Cancer

summary: A study that evaluates the benefits of a personalized remote exercise and physical activity coaching compared with the standard supportive approach in terms of health-related quality of life at 12 months in breast cancer survivors treated in an adjuvant setting.

lead_sponsor: Centre Oscar Lambret


title: Effectiveness of Mechanical Stimulation on Pain Level and Functional Discomfort Following a Total Mastectomy and Exploratory Axillary Surgery

summary: This study evaluates the effectiveness of mechanical stimulation technique compared to massages on pain level and functional discomfort (on the mobility of the shoulder) after 6 months, in breast cancer needing physiotherapy, following a total mastectomy and exploratory axillary surgery.


title: Predicting the Need for Intubation in Hospitalised COVID-19 Patients (PRED ICU COVID19)

summary:
One of the main challenges of the health crisis caused by the COVID-19 epidemic is the availability of beds in intensive care units (ICUs) and, more importantly, the need for invasive mechanical ventilation (IVM) because the ICUs are currently reserved for intubated patients.

The experiences of both China and Italy indicate that a certain number of COVID-19 patients will require mechanical ventilation. However, the limited number of resuscitation beds and ventilators requires strict use of these scarce resources. As a significant proportion about 5% to 10%, of patients initially admitted to hospital with COVID-19 will require ventilation, it is essential to anticipate their need for resuscitation to improve the rare resource of beds and ventilator shortages in intensive care units.

The hypothesis of the study is that, in proven or suspected hospitalised and oxygen-requiring COVID-19 patients, an early predictive clinical score, calculated over the three first days of admission may allow for an earlier identification of patients who will require intubation and transfer to an intensive care unit for orotracheal intubation

lead_sponsor: Central Hospital, Nancy, France

location_facility:
Louis Mourier hospital (AP-HP)
Brabois Hospital (CHRU de Nancy)


title: Epidemiology and Outcome of Anaphylactic Shocks Admitted to Intensive Care Unit: a French Retrospective Multicenter Study

acronym: ANAPHYLASHOCK

summary: Anaphylaxis is a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, accompanied with an increased number of hospitalizations. Although rare, this condition is often associated with a significant morbidity and mortality. The mortality rate has been recently estimated at 0.84 (95% CI, 0.79 to 0.88) per million per year in the French adult population. Age, chronic medication and cardiac or pulmonary comorbidities have been reported to increase the risk of a severe reaction. Obesity, age and cardiovascular comorbidities have been identified as risk factors for fatal anaphylaxis. However, the risk factors for death after ICU admission have not been elucidated yet.

ReferenceCitation: Guerci P, Tacquard C, Chenard L, Millard D, Soufir L, Malinovsky JM, Garot M, Lalot JM, Besch G, Louis G, Thion LA, Charpentier C, Kimmoun A, Danguy Des Déserts M, Carreira S, Plantefeve G, Novy E, Abraham P, Mertes PM; Societe Francaise d'Anesthesie et Reanimation (SFAR) Research Network. Epidemiology and outcome of patients admitted to intensive care after anaphylaxis in France: a retrospective multicentre study. Br J Anaesth. 2020 Dec;125(6):1025-1033. doi: 10.1016/j.bja.2020.08.024. Epub 2020 Sep 12.

family: Guerci

full_name: Philippe Guerci

family: Tacquard

full_name: Charles Tacquard

given: Charles

family: Chenard

full_name: Laura Chenard

given: Laura

family: Millard

full_name: David Millard

given: David

family: Soufir

full_name: Lila Soufir

given: Lila

family: Malinovsky

full_name: Jean-Marc Malinovsky

given: Jean-Marc

family: Garot

full_name: Matthias Garot

given: Matthias

family: Lalot

full_name: Jean-Marc Lalot

family: Besch

full_name: Guillaume Besch

given: Guillaume

family: Louis

full_name: Guillaume Louis

family: Thion

full_name: Laurie-Anne Thion

given: Laurie-Anne

family: Charpentier

full_name: Claire Charpentier

given: Claire

family: Kimmoun

full_name: Antoine Kimmoun

family: Danguy Des Déserts

full_name: Marc Danguy Des Déserts

given: Marc

family: Carreira

full_name: Serge Carreira

given: Serge

family: Plantefeve

full_name: Gaetan Plantefeve

given: Gaetan

family: Novy

full_name: Emmanuel Novy

given: Emmanuel

family: Abraham

full_name: Paul Abraham

given: Paul

family: Mertes

full_name: Paul-Michel Mertes

given: Paul-Michel

journal_name: British Journal of Anaesthesia

oa_host_type: publisher

evidence: open (via crossref license, author manuscript)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: acceptedVersion

location_facility:
University Hospital of Strasbourg
University Hospital of Nancy