title: A Prospective, Randomized, Open, Multicentric Study Intended to Evaluate the Efficacy and Tolerability of Sequential Treatment Based on Rabbit Anti-T-lymphocyte Serum, of Mycophenolate Mofetil and of Cyclosporin, Without Concomitant Corticosteroids, After a First Cadaveric Renal Transplant

summary: The trial is planned as a multicentric, randomized, prospective, open study in accordance with a 1/1 plan, on parallel groups and 2 arms of treatment. A total of 200 patients with chronic renal insufficiency, included in the French national waiting list of the Establishment Français des Greffes [French Transplants Institution] and receiving a first renal transplant will be included, after signed agreement, in this study. All the patients will receive organs taken from brain-dead subjects. The patients will be given immunosuppressant treatment based on rabbit anti-T lymphocyte serum, CellCeptÒ and NeoralÒ cyclosporin. One group of 100 randomised patients will be given standard corticosteroid therapy as well during the first six months following the transplant. This group will be compared with a second group of 100 randomised patients who will be given a single dose of corticosteroids. The main aim of this study is to evaluate the number of acute rejection episodes in patients given a first renal transplant and subjected to an immunosuppressant protocol not containing corticosteroids. The hypothesis which is proposed is that, in the absence of corticosteroids and/or calcineurin inhibitors (i.e. cyclosporin and tacrolimus), antilymphocyte serum results in a certain state of "tolerance" in respect of the allograft. The second objective concerns the beneficial effect which the absence of corticosteroids may have on short- and long-term postoperative morbidity and mortality. One may in fact assume that the absence of corticosteroids will result in an extension of the transplant patient's life expectancy as a result of the reduction in cardiovascular complications. Cardiovascular complications are the most frequent cause of death after a renal transplant.

ReferenceCitation: Cantarovich D, Rostaing L, Kamar N, Saint-Hillier Y, Ducloux D, Mourad G, Garrigue V, Wolf P, Ellero B, Cassuto E, Albano L, Soulillou JP; FRANCIA Study Trial Investigators Group. Corticosteroid avoidance in adult kidney transplant recipients under rabbit anti-T-lymphocyte globulin, mycophenolate mofetil and delayed cyclosporine microemulsion introduction. Transpl Int. 2010 Mar 1;23(3):313-24. doi: 10.1111/j.1432-2277.2009.00971.x. Epub 2009 Oct 19.

family: Cantarovich

full_name: Diego Cantarovich

given: Diego

family: Rostaing

full_name: Lionel Rostaing

given: Lionel

family: Kamar

full_name: Nassim Kamar

given: Nassim

family: Saint-Hillier

full_name: Yves Saint-Hillier

given: Yves

family: Ducloux

full_name: Didier Ducloux

given: Didier

family: Mourad

full_name: Georges Mourad

given: Georges

family: Garrigue

full_name: Valérie Garrigue

given: Valérie

family: Wolf

full_name: Philippe Wolf

given: Philippe

family: Ellero

full_name: Bernard Ellero

given: Bernard

family: Cassuto

full_name: Elizabeth Cassuto

given: Elizabeth

family: Albano

full_name: Laetitia Albano

given: Laetitia

family: Soulillou

full_name: Jean-Paul Soulillou

given: Jean-Paul

name: The FRANCIA Study Trial Investigators Group.

journal_name: Transplant International

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Nantes University Hospital

location_facility:
Strasbourg Universitary Hospital
Besançon Universitary Hospital
Montpellier Universitary Hospital
Nice Universitary Hospital
Nantes University Hospital


title: Morphologic Study of the Intersegmental Plane After Fully Thoracoscopic Segmentectomy

summary: The objective of this study is to determine whether stapling adversely affects the pulmonary parenchyma and the vascularisation of the adjacent segments. The aim of our work is to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy, 3 or 6 months post-surgery. the investigator will assess venous drainage and the arterial vascularisation of the remaining segments, possible modifications of the adjacent parenchyma and whether there is a defect of pleuro-pulmonary adhesion (residual pneumothorax).

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Institut Mutualiste Montsouris

location_facility:
Institut Mutualiste montsouris
Institut mutualiste montsouris

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Unknown


title: Immune Modulation Study in Patients With Metastatic Melanoma Treated With a First Line Therapy of Nivolumab +/- Ipilimumab (IMMUNONIVO/MelpredictPD1).

acronym: IMMUNONIVO

summary: This is an open bi-centric prospective non-randomized study in patients with metastatic melanoma treated with a first line treatment of Nivolumab +/- Ipilimumab. The aim of the study is to characterize the immune cells modulations under anti-PD-1 +/- anti-CTLA4 and identify the differences between responder and non-responder patients.

study_start_date_type: Anticipated

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

location_facility: Plateforme immuno-monitoring, Centre Leon Berard

location_facility: Service de Dermatologie, Centre Hospitalier Lyon Sud (HCL)

intervention_type: Biological

lead_sponsor_type: academique


title: Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy

acronym: ExplorASI

summary: The aim of this randomized study is to develop a new motor assessment of space exploration in a 2D environment with upper limbs for children with spinal muscular atrophy 1 and 2 from 3 until 16 years old.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

location_facility:
Hopital Raymond Poincare
Nicolas ROCHE, Md PhD

status_simplified: Completed


title: Pilot Study: Characterization of the Immune Phenotype of Patients Allergic to Wasp Venom or Penicillin

acronym: WasPenIP

summary: Severity of allergic reactions are highly variable from one individual to another, they can range from absent to life threatening. Allergic manifestations and specifically those of anaphylactic reactions are generally attributed to an IgE-dependent activation of mast cells and/or basophils followed by the release of histamine. Recently however evidence accumulated that other pathways might similarly contribute or even trigger anaphylaxis. Moreover, while the variance in human populations is an important subject to scientific research, medical practices and public health policies typically take a 'one for all' approach to disease management and drug development. Indeed, individual heterogeneity in the immune response can have a big impact on the likelihood to respond to therapy. Because of the complexity of immune responses in the individual and within the population, it has not been possible thus far to define the parameters (genetic or environmental) that define the immune system of allergic patients and its natural occurring variability. Thanks to the efforts that have been made in the framework of the Labex "Milieu Intérieur" study genetic, immunological and environmental factors have been identified that can be linked to the heterogeneity of immune responses in healthy individuals. By comparing these already available data from healthy individuals to a novel cohort of patients with defined severe allergic manifestations, we will be able to identify for the first time immunological and environmental parameters that are common to patients with severe allergies and identify those parameters that distinguish allergic patients from the healthy donor cohort. This analysis will thus open new perspectives on deregulated immune pathways in allergic patients allowing to orient future treatment approaches. Furthermore, comparing immune responses before and after allergen-specific immunotherapy will help understanding, which changes in immune responses are causal to a successful treatment. Importantly, this analysis will shed light on the individual differences that may predict the outcome of treatment approaches and propose novel markers of its success.

status: Recruiting

primary_purpose: Basic Science

lead_sponsor: Institut Pasteur

location_facility:
Service de Pneumologie Hôpital Bichat
Hôpital Saint Joseph

status_simplified: Ongoing


type: Other Identifier

title: Boosting Reward-based Attention Through VEstibular STimulation

acronym: BRAVEST

summary:
The exploration of space is more effective when intrinsically rewarding elements are located in the visual scene. Thus, rewards could be exploited as a novel rehabilitation approach to various attentional disorders. The first part of the project aims to characterize these effects at the behavioural level. The interventional part consists then in the administration of Caloric Vestibular Stimulation (CVS), which by means of injection of a small quantity of water in the external ear activates the vestibular organs and subsequently vestibular-related brain areas. Among the observed brain activations, the possibility to reach cingulate areas appears particularly interesting because it foreshadows the possibility to further enhance attentional capture by rewards.

CVS will be delivered to patients with brain lesion of the right hemisphere, engaged in cancellation tasks requiring the processing of targets of different nature (e.g. monetary or neutral). The main prediction is that CVS administration would enhance spatial exploration in terms of center of gravity of the cancellation and improved accuracy as a function of the type of target processed (e.g. its value).

location_facility: Service de médecine et réadaptation neurologique, Hôpital Henry Gabrielle

location_facility: CRNL, équipe IMPACT (CNRS UMR5292, INSERM U1028)

intervention_type: Procedure


type: Registry Identifier

title: Study to Elucidate the Association of the Renin-angiotensin System and Right Ventricular Function in Mechanically Ventilated Patients

summary: The purpose of this study is to assess whether circulating Angiotensin (Ang) II and Ang (1-7) levels are associated with right ventricular (RV) dysfunction in mechanically ventilated subjects. It is also designed to further characterize the subject population for severity of RV dysfunction. This study will investigate the association of renin-angiotensin system (RAS) peptides and markers of RV function, as measured by echocardiography, in subjects requiring acute mechanical ventilation. Maximum 150 subjects will be enrolled for the study and they will be evaluated over three days period using standard of care investigations, including trans-thoracic echocardiography (TTE) and/or trans-esophageal echocardiography (TOE) echocardiography. The maximum total duration of this study for subjects is 28 days.

status: Terminated

primary_purpose: Diagnostic

ipd_sharing: Yes

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline


title: Comparison of the Variability of Hepatic Load Quantification in Iron and Fat Estimated by MRI at 1.5 and 3 Tesla

acronym: HEMOCOMPARE

summary: The study proposes to compare the results of two examinations at 1.5 and 3 Tesla obtained on the same day on a series of 80 patients.

lead_sponsor: Rennes University Hospital

location_facility: Hôpital St Vincent du Groupement des Hôpitaux de l'Institut Catholique de Lille

intervention_type: Device


title: Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers: Phase 2 Study (RADICAL)

acronym: RADICAL

summary:
Hypothesis : Therapeutic intensification by increasing the dose delivered to the tumor by RCMI (conformational radiotherapy by intensity modulation) in order to reduce local relapse, often associated with poor prognosis

Primary objective: evaluate the rate of tumor sterilization and the toxicities of RTCT with concomitant boost in intensity modulation in patients with rectal cancer CT3-T4 and / or cN1-2.

primary_purpose: Treatment

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
Centre Gf Leclerc
CHRU de Besançon

intervention_type: Radiation


type: EudraCT Number

title: Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation

acronym: CHLOVIS

summary: Heart Failure (HF) with systolic dysfunction is associated with a poor prognosis in the long term despite the use of many effective drug treatment in reducing morbidity and mortality. In this context, cardiac resynchronization (CR), either alone or combined with a defibrillator function, has improved by about 30 to 40% of morbidity and mortality in this population of patients with heart failure. The information on the CR are now well established for patients with stage III-IV NYHA (New York Heart Association), with systolic dysfunction (EF ≤ 35%), presence of left bundle branch block wide (≥ 120 ms) and when medical treatment is optimal. As a result, the number of implanted devices continue to grow even if the implant procedures of cardiac resynchronization devices (CRD) are long, difficult and associated with significant complications with a risk of reoperation estimated between 10 and 15% . One of the most feared during implantation devices stimulation or defibrillation risk is represented by the risk of infection that will lead inevitably to explantation of the device. Despite the use of several preventive measures, including the use of an antiseptic shower, a local preparation for alcoholic povidone iodine (API) (PVPI 5% ethanol + 70%) and antibiotic prophylaxis clinical studies the most recent have clearly demonstrated that the risk of infection was associated with the duration of the intervention and was higher for procedures CR, it is noted in 2.4% in the short term and would be close to 3 to 4% in the medium term. Infections of implantable devices are associated with a poor prognosis, even in an excess mortality. It has been shown that the majority of infections may be linked to local contamination during surgery reinforcing the idea that prevention is mainly based on local measures and the reduction of operating time.

design_allocation: Randomized

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de Strasbourg
CHU d'Angers
CH d'Aix en Provence
CHU d'Amiens
CHU de Clermont-Ferrand
CHU de Montpellier
CH d'Annecy
CH de Périgueux
CHU de Toulouse
CHU de Bordeaux
CHU de Grenoble
CH d'Avignon
CHU de Caen
CHU de Dijon
CHU de Lille
CH la Rochelle
CHU de Rouen
CHU de Brest
AP-HM
CH de Chartres
CHU de Reims
CHU de Saint-Etienne
Ch St Joseph St Luc
CHU de Nimes

intervention_type: Drug


title: An Open-label, Phase II Study to Explore the Safety and Efficacy of Imatinib With Chemotherapy in Pediatric Patients With Ph+ / BCR-ABL+ Acute Lymphoblastic Leukemia (Ph+ALL)

acronym: ESPHALL

summary: The purpose of this study is to determine whether Imatinib is safe and effective in association with intensive treatment of Ph+ALL in children.

ReferenceType: derived

ReferenceCitation: Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0.

family: Tasian

full_name: Sarah K Tasian

given: Sarah K

sequence: first

family: Peters

full_name: Christina Peters

given: Christina

sequence: additional

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet Haematology

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Biondi A, Gandemer V, De Lorenzo P, Cario G, Campbell M, Castor A, Pieters R, Baruchel A, Vora A, Leoni V, Stary J, Escherich G, Li CK, Cazzaniga G, Cavé H, Bradtke J, Conter V, Saha V, Schrappe M, Grazia Valsecchi M. Imatinib treatment of paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia (EsPhALL2010): a prospective, intergroup, open-label, single-arm clinical trial. Lancet Haematol. 2018 Dec;5(12):e641-e652. doi: 10.1016/S2352-3026(18)30173-X.

family: Biondi

full_name: Andrea Biondi

given: Andrea

family: Gandemer

full_name: Virginie Gandemer

given: Virginie

family: De Lorenzo

full_name: Paola De Lorenzo

given: Paola

family: Cario

full_name: Gunnar Cario

given: Gunnar

family: Campbell

full_name: Myriam Campbell

given: Myriam

family: Castor

full_name: Anders Castor

given: Anders

family: Pieters

full_name: Rob Pieters

given: Rob

family: Baruchel

full_name: André Baruchel

given: André

family: Vora

full_name: Ajay Vora

given: Ajay

family: Leoni

full_name: Veronica Leoni

given: Veronica

family: Stary

full_name: Jan Stary

given: Jan

family: Escherich

full_name: Gabriele Escherich

given: Gabriele

family: Li

full_name: Chi-Kong Li

given: Chi-Kong

family: Cazzaniga

full_name: Giovanni Cazzaniga

given: Giovanni

family: Cavé

full_name: Hélène Cavé

given: Hélène

family: Bradtke

full_name: Jutta Bradtke

given: Jutta

family: Conter

full_name: Valentino Conter

given: Valentino

repository_institution: The University of Manchester - Research Explorer

ReferenceCitation: Biondi A, Schrappe M, De Lorenzo P, Castor A, Lucchini G, Gandemer V, Pieters R, Stary J, Escherich G, Campbell M, Li CK, Vora A, Aricò M, Röttgers S, Saha V, Valsecchi MG. Imatinib after induction for treatment of children and adolescents with Philadelphia-chromosome-positive acute lymphoblastic leukaemia (EsPhALL): a randomised, open-label, intergroup study. Lancet Oncol. 2012 Sep;13(9):936-45. doi: 10.1016/S1470-2045(12)70377-7. Epub 2012 Aug 14.

location_facility: Hôpital DEBROUSSE Institut d'hématologie et d'oncologie pédiatrique

location_facility: Service d'Immuno Hémato Oncologie Pédiatrique - Hôpital Charles Nicolle

location_facility: Service d'hématologie pédiatrique - Hôpital Sud

location_facility: Hématologie, Oncologie pédiatrique-CHU Saint Etienne

location_facility: Service hématologie pédiatrique Hôpital Saint-Jacques

location_facility: Hémato-Oncologie Pédiatrique - Hôpital d'Enfants

location_facility: Hémato-Oncologie et Thérapie Cellulaire Pédiatrique - Hôtel Dieu

location_facility: Hématologie oncologie pédiatrique-CHU Caen

location_facility: Service d'hémato-oncologie - Hôpital des Enfants Pellegrin

location_facility: Hématologie Pédiatrique - Hôpital Trousseau


title: Repetitive Transcranial Magnetic Stimulation Efficacy for Major Resistant Depression Compared or Associated With Venlafaxine : a Multicentric Study.

summary: The purpose of this study is to assess the efficacy of add-on therapy with repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of major depressive disorders compared to venlafaxine only (the optimal medication) and to rTMS only.

ReferenceCitation: Brunelin J, Jalenques I, Trojak B, Attal J, Szekely D, Gay A, Januel D, Haffen E, Schott-Pethelaz AM, Brault C; STEP Group, Poulet E. The efficacy and safety of low frequency repetitive transcranial magnetic stimulation for treatment-resistant depression: the results from a large multicenter French RCT. Brain Stimul. 2014 Nov-Dec;7(6):855-63. doi: 10.1016/j.brs.2014.07.040. Epub 2014 Aug 7.

family: Brunelin

full_name: Jerome Brunelin

given: Jerome

family: Jalenques

full_name: Isabelle Jalenques

given: Isabelle

family: Trojak

full_name: Benoit Trojak

given: Benoit

family: Attal

full_name: Jerome Attal

family: Szekely

full_name: David Szekely

given: David

family: Gay

full_name: Aurélia Gay

given: Aurélia

family: Januel

full_name: Dominique Januel

given: Dominique

family: Haffen

full_name: Emmanuel Haffen

given: Emmanuel

family: Schott-Pethelaz

full_name: Anne-Marie Schott-Pethelaz

given: Anne-Marie

family: Brault

full_name: Coralie Brault

given: Coralie

family: Poulet

full_name: Emmanuel Poulet

journal_name: Brain Stimulation

title: The Efficacy and Safety of Low Frequency Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression: The Results From a Large Multicenter French RCT

lead_sponsor: Club rTMS et Psychiatrie

location_country: Monaco France

location_facility: C.H.U. Dijon, Hôpital Général - Service de Psychiatrie et d'Addictologie

location_facility: Hôpital Sainte Anne - Service Hospitalo-Universitaire de Santé Mentale et de Thérapeutique

location_facility: EPS de Ville Evrard - Unité de Saint-Denis

location_facility: C.H.U. Saint-Jacques - Service de Psychiatrie de l'Adulte

location_facility: C.H.U. de Grenoble, Hôpital sud - Département de Psychiatrie

location_facility: C.H.U. Charles Nicolle - Service Hospitalo-Universitaire de Psychiatrie

location_facility: C.H.U. Gabriel Montpied - Service de Psychiatrie et Psychologie Médicale - CMP A

location_facility: C.H. Le Vinatier - EA 4166, UCB Lyon 1 - Department of Psychiatry - Service du Pr d'AMATO


title: Interest of Bone Scintigraphy in Pre-operative Assessment of Knee Osteoarthritis in Patients Undergoing Unicompartmental Knee Arthroplasty

acronym: PUC-INTEVO

summary: Study the potential interest of bone scintigraphy for patients undergoing unicompartmental knee arthroplasty

study_type: Observational

time_perspective: Retrospective

lead_sponsor: University Hospital, Brest

location_facility:
Clinique de La Baie
CHRU de Brest


title: Phase II Trial With Lenalidomide-Dexamethasone Combination in the Treatment of POEMS Syndrome.

acronym: POEMS

summary:
POEMS syndrome is a rare form of B cell dyscrasia combining a proliferation usually of plasma cells, a polyneuropathy, osteocondensing bone lesions and multiple other clinical signs. Lenalidomide appears to be particularly efficient in this pathology.

The investigators propose a phase II multicentre protocol, based on the use of lenalidomide combined with dexamethasone in patients presenting a POEMS syndrome, either de novo or resistant or in relapse.

Patients who can be treated by local radiation or intensive treatment with stem cell support will undergo 2 cycles of the lenalidomide-dexamethasone (Len-Dex) combination before radiation or intensive treatment (Group 1), the other patients will undergo 9 cycles of the Len-Dex combination (Group 2).

A biological study is coupled with this clinical protocol in order to define the best biological markers predicting clinical responses, to better understand the POEMS pathophysiological mechanisms and to set up a bank of samples which can be used to study this rare pathology.

lead_sponsor: University Hospital, Limoges

location_facility:
CHU de Caen
Centre Léon Bérard
Hôpital Necker
CHU de Nantes
CHU d'Angers
CHU de Lille
CHU de Limoges
Hospices Civil de Lyon
Pitié Salpétrière
Hôpital Saint-Louis
CHU de Toulouse


title: A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions

summary: The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

ReferenceType: background

ReferenceCitation: Morice MC. XIENCE V SPIRIT WOMEN clinical trial: characterization of the female population undergoing stent implantation. Womens Health (Lond). 2008 Sep;4(5):439-43. doi: 10.2217/17455057.4.5.439.

ReferenceCitation: Franzone A, Zaugg S, Piccolo R, Modena MG, Mikhail GW, Ferré JM, Strasser R, Grinfeld L, Heg D, Jüni P, Windecker S, Morice MC. A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study. PLoS One. 2017 Aug 10;12(8):e0182632. doi: 10.1371/journal.pone.0182632. eCollection 2017.

family: Franzone

full_name: Anna Franzone

given: Anna

family: Zaugg

full_name: Serge Zaugg

given: Serge

family: Piccolo

full_name: Raffaele Piccolo

given: Raffaele

family: Modena

full_name: Maria Grazia Modena

given: Maria Grazia

family: Mikhail

full_name: Ghada W. Mikhail

given: Ghada W.

family: Ferré

full_name: Josepa Mauri Ferré

given: Josepa Mauri

family: Strasser

full_name: Ruth Strasser

given: Ruth

family: Grinfeld

full_name: Liliana Grinfeld

given: Liliana

family: Heg

full_name: Dik Heg

given: Dik

family: Jüni

full_name: Peter Jüni

given: Peter

family: Windecker

full_name: Stephan Windecker

given: Stephan

family: Morice

full_name: Marie-Claude Morice

given: Marie-Claude

currency_apc_doaj: USD

journal_name: PLOS ONE

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

repository_institution: PubMed Central - Europe PMC

endpoint_id: nbfzapbzoypsdcgeiryx

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

repository_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

location_country: Italy Austria Brazil Switzerland Netherlands France Poland Norway Hungary Argentina Belgium Spain Denmark Germany Latvia

location_facility: Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II

location_facility: Technische Universität Dresden, Medizinische Klinik II - Kardiologie

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hosital Italiano de Buenos Aires - Cardiologia

location_facility: Semmelweis University, Department of Cardiovascular Surgery

location_facility: Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena

location_facility: Latvian Center of Cardiology, P. Stradina University Hospital

location_facility: Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia

location_facility: Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO

location_facility: Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud

location_facility: Kardiologische Klinik Herz- und Diabeteszentrum

location_facility: Instituto Cardiovascular de Buenos Aires-ICBA


title: Continuation of the Exploration of the Standing Seated Passage of the Hemiplegic for the Realization of a New Transport Device

summary:
This is a study for a new mechanical transport device adapted to the hemiplegic patients.

Healthy volunteers :

After explaining the protocol and presenting the movement laboratory, the subjects are equipped with reflective markers on the 4 limbs, the trunk and the head. The subjects are installed on a seat positioned in front of 2 force platforms installed on the ground. The seat is equipped with a force platform.

Phase 1 :

After being seated, the subject realizes :

3 seat to stand and stand to seat without assistance
3 seat to stand and stand to seat using a handle located in front of it (handle equipped with a 6-axis force sensor)
3 seat to stand and stand to seat using the experimental device This phase will last 45minutes (mn) (30mn of equipment and 15mn of sitting passengers standing)

Phase 2:

After being seated, the subject performs a course comprising:

A standing pass from sitting on a chair
A straight line movement
A succession of left and right turns
An upward and downward travel of less than 1%.
Standard doorway
Standing on the toilet
A sitting pass from the toilet
One way to a bed
A sitting pass on the bed
A passenger seat sitting upright from the bed
A return to the starting point
A sitting pass on the starting chair Each stage is timed. A subjective analysis of each step is done by a lickert scale on the perceived comfort and safety.

This phase 2 will last 30mn (15mn of course and 15mn of questions).

Hemiplegic subjects :

At each session, the subject is examined by a physician who evaluates the motor control (Fugl Meyer scale), the equilibrium (Berg scale) and the spatial hemineglect (Bergego scale).

Phase 1 is performed except the 3 seat to stand and stand to seat without assistance which are impossible.

Phase 2 is performed. An evaluation of the device over 4 hours is carried out for each subject in therapeutic apartment in simulated living conditions. The validation in living lab is carried out by an ergonomist and by a questionnaire on the comfort and safety of the various steps identified by the ergonomist.

primary_purpose: Device Feasibility

location_facility: Centre de rééducation fonctionnelle de KERPAPE


title: Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia (VAP): an Ancillary Study of the DEMETER Trial (NCT02515617)

summary:
Many studies provide evidence for the benefit of lower respiratory tract surveillance, mostly by culture of endotracheal secretions, to predict bacterial pathogens (especially multi-drugs resistant pathogens) involved in VAP. The DEMETER study (NCT02515617) assessing the medico-economical impact of the subglottic secretions drainage (SSD) provides the opportunity to evaluate the accuracy of the subglottic secretions culture surveillance to predict pathogens involved in VAP (in comparison with the concomitant endotracheal secretions surveillance). These subglottic and tracheal secretions culture surveillance will be masked to the investigators of the DEMETER Study.

This ancillary study will be performed in 14 centers participating to the DEMETER study

ReferenceCitation: Brusselaers N, Labeau S, Vogelaers D, Blot S. Value of lower respiratory tract surveillance cultures to predict bacterial pathogens in ventilator-associated pneumonia: systematic review and diagnostic test accuracy meta-analysis. Intensive Care Med. 2013 Mar;39(3):365-75. doi: 10.1007/s00134-012-2759-x. Epub 2012 Nov 28. Review.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_country: Belgium France

location_facility: CHU La Réunion, site de Saint Denis de la Réunion

location_facility: Centre Hospitalier Intercommunal des Portes de l'Oise


title: Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation: an Ancillary Study of the DEMETER Trial (NCT02515617)

summary:
Meta-analysis provide evidence for the benefit of the subglottic secretions drainage (SSD) to reduce the occurrence of Ventilator-Associated Pneumonia (VAP). Nevertheless, the diagnosis of VAP is widely considered as subjective and prone to both false-positive and false negative assignments. In ths way, the impact of SSD remains controversial and its use limited in Intensive Care Units. The DEMETER study assessing the medico-economical impact of the the subglottic secretions drainage (NCT02515617) provides the opportunity to evaluate the dynamics of tracheal colonisation with and without the realisation of SSD. This evaluation would reinforce the results observed during the DEMETER study in considering the adjudicated VAP incidence.

This ancillary study will be performed in 14 centers participating to the DEMETER study

ReferenceCitation: Girou E, Buu-Hoi A, Stephan F, Novara A, Gutmann L, Safar M, Fagon JY. Airway colonisation in long-term mechanically ventilated patients. Effect of semi-recumbent position and continuous subglottic suctioning. Intensive Care Med. 2004 Feb;30(2):225-233. doi: 10.1007/s00134-003-2077-4. Epub 2003 Nov 29.


title: A Randomized Open-label Phase II Multicenter Trial Assessing the Efficacy and Safety of tamOxifen Plus LY2228820 in Advanced or Metastatic Breast Cancer Progressing on aromatasE Inhibitors

acronym: OLYMPE

summary:
Metastatic breast cancer (MBC) remains an incurable disease and despite an improvement of the effect of systemic treatments. After relapse on first-line non-steroidal aromatase inhibitor, current clinical practice and treatment guidelines include tamoxifen, fulvestrant (an ER antagonist) and exemestane as available options (NCCN treatment guidelines 2012), but in this context of resistance, their efficacy are poor.

Some results confirm the possibility to improve the efficacy of tamoxifen in metastatic setting by a combination with therapy targeting signal transduction pathways. Other transduction pathways seem to be involved in endocrine sensitivity/resistance, such as RAS/RAF/MEK/MAK pathway.

LY2228820 inhibits the activity of p38 MAPK (selective inhibitor of the α and β isoforms of p38 MAPK in vitro) and reduces phosphorylation of its cellular target, MAPK-activated protein kinase 2 (MAPKAP-K2).

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Eugène Marquis
Centre Léon Bérard
Centre Georges-François Leclerc
Centre François Baclesse
Institut de Cancérologie de l'Ouest
Centre Jean Perrin
Institut Claudius Regaud
Hegp, Ap-Hp
Institut Paoli Calmettes
Institut Curie
Institut Bergonié
Centre Henri Becquerel
Hôpital St Louis, AP-HP
Institut Gustave Roussy


title: Asthma Attack in the Emergency Department : Reasons Of This Attendance

acronym: AERO

summary:
Objective: Identify modifiable factors that may affect asthma control and the use of emergency room to define customized interventions for the management of asthma prior to emergency room.

Emergency department attendance is always a sign of poor balance or control of asthma. In spite of a decrease in the number of deaths that has been halved in 20 years and hospitalization due to asthmatic disease, the use of emergency center for this disease has not decreased. We now know that the passage through emergencies and hospitalization for aggravation of asthma is in itself a factor of mortality. Acting on the determinants of poor balance or control of asthma is essential to further reduce the mortality and morbidity of asthma.

time_perspective: Prospective

lead_sponsor: Olivier CHASSANY

location_facility: Service d'acceuil des urgences hôpital Bichat- Claude Bernard

location_facility: Service d'accueil des urgences Hôpital Beaujon


title: TREg Activation in the Treatment of the PELADE (Alopecia Areata). Double Blind Randomized Placebo Controlled Comparative Study Using Low Doses of IL2

acronym: TreatPelade

summary:
In a prospective pilot study the investigators showed that low doses of IL2 could be beneficial for severe AA inducing a long lasting regrowth in 4 out of the 5 patients treated.

The objective of this study is to compare the long term efficacy of low doses of IL2 versus placebo in a multicenter prospective randomized double blind study.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
AP-HM - La timone - Dermatologie
CHU de Nimes - Dermatologie
AP-HP St Louis - Dermatologie
CHU Montpellier - Dermatologie
CHU de Nice - dermatologie
CHI St Raphael Fréjus - Dermatologie


title: Strain Analysis as a Right Ventricle Contractility Marker

summary: The analysis of the systolic function (contractility) of the right ventricle (RV) is fundamental and central in many pathologies in intensive care unit. It can guide physicians in choosing therapeutics. The conventional ultrasound markers of RV function evaluation currently used are influenced by RV loading conditions, impairing their capacity to approximate a true contractility analysis. Myocardial strain imaging is a recent echographic technique that allows, among other things, to evaluate RV systolic function. It is a reproducible index with early variations which, if it proved to be independent pre-load, would help to better appreciate the RV contractility.

location_facility:
Hôpital de la Croix Rousse
Hopital Saint Joseph Saint Luc


title: Prospective, Randomized, Double-blind, Placebo-controlled Study on Parallel Groups Evaluating the Efficacy and Safety of Cranberry (Vaccinium Macrocarpon) in Prevention of Urinary Tract Infections in Multiple Sclerosis Patients.

acronym: CANNEBERGE

summary: Bladder dysfunction occurs at some time in most patients with multiple sclerosis and these patients are prone to have recurrent urinary tract infections. Cranberry has been traditionally used for the treatment and prophylaxis of urinary tract infections but there is no reliable randomized controlled trial demonstrating evidence of cranberry's utility in this disease. The aim of our study is to assess the efficacy and safety of cranberry in the prophylaxis of urinary tract infections in patients with multiple sclerosis with a prospective randomized, double-blind and placebo-controlled clinical trial.

ReferenceCitation: Gallien P, Amarenco G, Benoit N, Bonniaud V, Donzé C, Kerdraon J, de Seze M, Denys P, Renault A, Naudet F, Reymann JM. Cranberry versus placebo in the prevention of urinary infections in multiple sclerosis: a multicenter, randomized, placebo-controlled, double-blind trial. Mult Scler. 2014 Aug;20(9):1252-9. doi: 10.1177/1352458513517592. Epub 2014 Jan 8.

name: Physical Medicine and Rehabilitation Center, Saint Hélier Clinic, Rennes, France

name: Department of Physical Medicine and Rehabilitation, Pontchaillou Hospital, Rennes University Hospital and University of Rennes 1, Rennes, France

family: Gallien

full_name: Philippe Gallien

given: Philippe

name: Department of Neuro-Urology, Tenon Hospital, and Pierre and Marie Curie University, Paris, France

family: Amarenco

full_name: Gérard Amarenco

given: Gérard

family: Benoit

full_name: Nicolas Benoit

given: Nicolas

name: Multidisciplinary Pelviperineology and Rehabilitation Unit, Dijon University Hospital, Dijon, France

family: Bonniaud

full_name: Véronique Bonniaud

given: Véronique

name: Department of Physical Medicine and Rehabilitation, Saint Philibert Hospital, Lille Catholic Institute Hospital Group, Lomme, France

family: Donzé

full_name: Cécile Donzé

given: Cécile

name: Kerpape Functional Rehabilitation Center, Ploemeur, France

family: Kerdraon

full_name: Jacques Kerdraon

given: Jacques

name: Neuro-Urology, Pelviperineology and Urodynamic Clinical Center, Clinique Saint Augustin, Bordeaux, France

family: de Seze

full_name: Marianne de Seze

given: Marianne

name: Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, Garches, France

family: Denys

full_name: Pierre Denys

given: Pierre

name: Clinical Investigation Center, Pontchaillou Hospital, Rennes University Hospital and University of Rennes 1, Rennes, France

family: Renault

full_name: Alain Renault

given: Alain

name: Experimental and Clinical Pharmacology Laboratory, Faculty of Medicine, Rennes, France

family: Naudet

full_name: Florian Naudet

given: Florian

family: Reymann

full_name: Jean Michel Reymann

given: Jean Michel

journal_name: Multiple Sclerosis Journal

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

location_facility: Service de médecine physique et réadapation Hopital de Rangueil

location_facility: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE

location_facility: Rééducation Neurologique et Explorations Périnéales - Hôpital Rothschild

location_facility: Service de Médecine Physique et Réadaptation - Hôpital Raymond Poincaré

location_facility: Centre de Médecine Physique et Réadaptation Notre Dame de Lourdes

location_facility: Consultations maladies infectieuses et tropicales, Hôpital Raymond Poincaré

location_facility: Unité de Médecine Physique et Réadaptation - CHU Jean Minjoz

location_facility: Médecine Physique et Réadaptation - Groupe Hospitalier de l'institut Catholique de Lille - Hôpital Saint Philibert

location_facility: Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou

location_facility: Service de Médecine Physique et Réadaptation - Hôpital Pellegrin


title: IFM 2014-02 Study: A Randomized Phase III Study of Bortezomib-Melphalan 200 Conditioning Regimen Versus Melphalan 200 for Frontline Transplant Eligible Patients With Multiple Myeloma

summary: Phase III multicenter randomized, open-label study comparing the efficacy of a combined high dose chemotherapy using melphalan and bortezomib versus melphalan alone followed by stem cell transplant in frontline multiple myeloma patients, non-progressive after induction therapy.

status: Active, not recruiting

lead_sponsor: University Hospital, Toulouse

location_facility: Grand Hôpital de Charleroi - Site Notre-Dame

location_facility: Centre Hospitalier de Versailles-Hôpital André Mignot

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth


title: Trabectedin Combined With Durvalumab (MEDI4736) in Patients With Advanced Pretreated Soft-tissue Sarcomas and Ovarian Carcinomas. A Phase Ib Study.

acronym: TRAMUNE

summary: A phase Ib trial study of trabectedin when prescribed in combination with durvalumab in locally advanced/unresectable soft-tissue sarcoma and ovarian carcinomas.

lead_sponsor: Institut Bergonié

location_facility:
Institut Bergonié
Centre Léon Bérard


title: Study of the Analgesic Effect of the Perineal Infiltration of Ropivacaine 0.75% Versus Placebo in Post-episiotomy Perineal Pain: a Randomized, Double-blind Study

acronym: ROPISIO

summary:
Episiotomy is a common obstetric gesture (20 to 30% of deliveries by the low route). In postpartum, perineal pains associated with episiotomy are common, about 70% on D7 and persistent 13% at 5 months. Most studies of obstetrical analgesia have focussed on pain during labor or following a caesarean section. The perineal pain associated with the realization of an episiotomy has been much less studied and often undervalued.

Local ropivacaine has shown its effectiveness in the reduction of postoperative pain in many indications (wall surgery, hemorrhoidectomy, infiltration of trocar scars during laparoscopy). This product has the advantage of being well tolerated, easy access and administration. Three recent studies compared the post-episiotomy analgesic efficacy of local ropivacaine versus lidocaine versus placebo and lidocaine versus no infiltration. Two of these studies showed statistically significant results. However, they focused on the results at 24 and 48 hours and did not evaluate the analgesic efficacy in the medium and long term.

ReferenceCitation: Cardaillac C, Ploteau S, Le Thuaut A, Dochez V, Winer N, Ducarme G. Ropivacaine 75 mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women - the ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trials. Trials. 2020 Jun 12;21(1):522. doi: 10.1186/s13063-020-04423-x.

family: Cardaillac

full_name: Claire Cardaillac

given: Claire

family: Ploteau

full_name: Stéphane Ploteau

given: Stéphane

family: Le Thuaut

full_name: Aurélie Le Thuaut

given: Aurélie

family: Dochez

full_name: Vincent Dochez

given: Vincent

family: Winer

full_name: Norbert Winer

given: Norbert

family: Ducarme

full_name: Guillaume Ducarme

given: Guillaume

currency_apc_doaj: GBP

journal_name: Trials

evidence: oa repository (via page says license)

repository_normalized: Research Square

repository_institution: Research Square - Research Square

repositories:
PubMed Central
Research Square

repositories_institution:
PubMed Central - Europe PMC
Research Square - Research Square

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Ropivacaine 75 mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women – the ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trials

location_facility:
Centre Hospitalier Universitaire Nantes
Centre Hospitalier Departemental Vendee


title: Brain-computer Interface in the Diagnosis of Disorders of Consciousness

acronym: AWAKE

summary:
The objective of this study is to show that the measurement of auditory and vibro-tactile evoked potentials, or the recording of the EEG signal during a motor imaging task, can be used in routine clinical situations to explore the state of consciousness of subjects in Non-responsive Awakening (or Chronic Vegetative State) or in Minimal Consciousness (or relational state) after a severe brain injury.

Assumptions :

Correlation between patient response rates obtained with the brain-machine interface and their clinical consciousness score (Coma Recovery Scale Revised score)
Differentiation of the parameters of the evoked potentials P300 between patients in a vegetative state and those in a state of minimal consciousness

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Montpellier
CHU de Nîmes
Clinique Fontfroide
Hôpital d'Uzès


title: Randomized Trial of Loco-regional Radiotherapy Added to Pembrolizumab Versus Pembrolizumab Alone for Patients With Newly Diagnosed Head and Neck Squamous Cell Carcinoma With Synchronous Metastases

acronym: PembroMetaRT

summary: Trial evaluating the efficacy of radiotherapy added to pembrolizumab compared to pembrolizumab alone for patients with newly diagnosed head and neck carcinoma with metastases

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

lead_sponsor: UNICANCER

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: Institut de Cancérologie Strasbourg-Europe


title: A Phase I/IIa Trial to Evaluate the Safety and Efficacy of the Combination of the Oncolytic Immunotherapy Pexa-Vec With the PD-1 Receptor Blocking Antibody Nivolumab in the First-line Treatment of Advanced Hepatocellular Carcinoma (HCC)

summary: This is a study to Evaluate the Safety and Efficacy of the Combination of the Oncolytic Immunotherapy Pexa-Vec With the PD-1 Receptor Blocking Antibody Nivolumab in the First-line Treatment of Advanced Hepatocellular Carcinoma (HCC).

lead_sponsor: Transgene

location_facility:
Site No 0102
Site No 0101


title: A Multicentre, Controlled, Randomised, Single-blind, Two-armed Trial Evaluating the Visual Performance, Quality of Vision and Subjective Outcomes After Bilateral Implantation of MINI WELL Ready® or FineVision® in Patients With Cataract Surgery.

summary: Interventional, Multicentre, controlled, randomized, single blind, twoarmed non-inferiority trial

lead_sponsor: SIFI SpA

location_facility:
Ophtalmologie Hôpital Morvan
Clinique Juge


title: Contribution of a Semantic Therapy on a Tactile Tablet in the Alzheimer's Disease, Early and Late Onset

acronym: SemantiMATT

summary:
Lexical semantic disorders are described in Alzheimer's disease, and their incidence in everyday life is important to the extent that these disorders affect expression and comprehension.

Providing a tactile tablet stimulation, independent and complementary to speech therapy, could help to maintain certain abilities and reinforce the feeling of autonomy of the patients.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
APHP - Pitié-Salpêtrière Hospital
Hôpital Pitié-Salpêtriere


title: FRench Acute Cerebral Multimodal Imaging to Select Patient for MEchanical Thrombectomy

acronym: FRAME

summary: FRench Acute cerebral multimodal imaging to select patient for MEchanical thrombectomy is a prospective multi-center study to determine if multimodal imaging could identify patients who may and those who may not benefit from an endovascular clot removal procedure within 6 hours after stroke onset.

ReferenceCitation: Fontaine L, Sibon I, Raposo N, Albucher JF, Mazighi M, Rousseau V, Darcourt J, Thalamas C, Drif A, Sommet A, Viguier A, Guenego A, Januel AC, Calvière L, Menegon P, Bonneville F, Tourdias T, Albers GW, Cognard C, Olivot JM; FRAME Investigators. ASCOD Phenotyping of Stroke With Anterior Large Vessel Occlusion Treated by Mechanical Thrombectomy. Stroke. 2021 Oct 27:STROKEAHA121035282. doi: 10.1161/STROKEAHA.121.035282. [Epub ahead of print]

name: Acute Stroke Unit, Bordeaux University Hospital, France. (L.F., N.R., J.-F.A., A.V., L.C., J.-M.O.)

name: Clinical Investigation Center, Bordeaux University Hospital, France. (L.F., N.R., J.-F.A., V.R., C.T., A.D., A.S., A.V., L.C., J.-M.O.)

name: Toulouse Neuro Imaging Center, Bordeaux University Hospital, France. (L.F., N.R., J.-F.A., A.V., L.C., J.-M.O.)

family: Fontaine

full_name: Louis Fontaine

given: Louis

name: Stroke Unit, Bordeaux University Hospital, France. (I.S.)

family: Sibon

full_name: Igor Sibon

given: Igor

family: Raposo

full_name: Nicolas Raposo

family: Albucher

full_name: Jean-François Albucher

given: Jean-François

name: University of Paris U1148, Rothschild Foundation Hospital, France (M.M.).

family: Mazighi

full_name: Michael Mazighi

given: Michael

family: Rousseau

full_name: Vanessa Rousseau

given: Vanessa

name: Department of Neuroradiology, Bordeaux University Hospital, France. (J.D., A.-C.J., F.B., C.C.)

family: Darcourt

full_name: Jean Darcourt

given: Jean

family: Thalamas

full_name: Claire Thalamas

family: Drif

full_name: Amel Drif

given: Amel

family: Sommet

full_name: Agnes Sommet

given: Agnes

family: Viguier

full_name: Alain Viguier

name: Stanford Stroke Center, Stanford University, CA (A.G., G.W.A.).

family: Guenego

full_name: Adrien Guenego

given: Adrien

family: Januel

full_name: Anne-Christine Januel

given: Anne-Christine

family: Calvière

full_name: Lionel Calvière

given: Lionel

name: Department of Neuroradiology, Bordeaux University Hospital, France. (P.M., T.T.)

family: Menegon

full_name: Patrice Menegon

given: Patrice

family: Bonneville

full_name: Fabrice Bonneville

given: Fabrice

family: Tourdias

full_name: Thomas Tourdias

given: Thomas

family: Albers

full_name: Gregory W. Albers

given: Gregory W.

family: Cognard

full_name: Christophe Cognard

given: Christophe

family: Olivot

full_name: Jean-Marc Olivot

given: Jean-Marc

family: Christensen

full_name: Soren Christensen

given: Soren

family: Mlynash

full_name: Michael Mlynash

family: Chollet

full_name: François Chollet

given: François

publisher: Ovid Technologies (Wolters Kluwer Health)

location_facility:
U H Bordeaux
University hospital Toulouse


title: Assessment of Perioperative Morbidity in Gyneco-oncology According to the Surgical Approach : Coelioscopy Versus Robot-assisted Coelioscopy

acronym: ROBO-GYN

summary: The purpose of this study is to compare perioperative morbidity of coelioscopy versus robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.

ReferenceCitation: Narducci F, Bogart E, Hebert T, Gauthier T, Collinet P, Classe JM, Lecuru F, Delest A, Motton S, Conri V, Ferrer C, Marchal F, Ferron G, Probst A, Thery J, Le Deley MC, Lefebvre D, Francon D, Leblanc E, Lambaudie E. Severe perioperative morbidity after robot-assisted versus conventional laparoscopy in gynecologic oncology: Results of the randomized ROBOGYN-1004 trial. Gynecol Oncol. 2020 Aug;158(2):382-389. doi: 10.1016/j.ygyno.2020.05.010. Epub 2020 May 25.

family: Narducci

full_name: Fabrice Narducci

family: Bogart

full_name: Emilie Bogart

given: Emilie

family: Hebert

full_name: Thomas Hebert

family: Gauthier

full_name: Tristan Gauthier

given: Tristan

family: Collinet

full_name: Pierre Collinet

given: Pierre

family: Classe

full_name: Jean Marc Classe

given: Jean Marc

family: Lecuru

full_name: Fabrice Lecuru

family: Delest

full_name: Alain Delest

given: Alain

family: Motton

full_name: Stephanie Motton

given: Stephanie

family: Conri

full_name: Vanessa Conri

family: Ferrer

full_name: Catherine Ferrer

given: Catherine

family: Marchal

full_name: Frederic Marchal

given: Frederic

family: Ferron

full_name: Gwenael Ferron

given: Gwenael

family: Probst

full_name: Alicia Probst

given: Alicia

family: Thery

full_name: Julien Thery

given: Julien

family: Le Deley

full_name: Marie-Cécile Le Deley

given: Marie-Cécile

family: Lefebvre

full_name: Daniele Lefebvre

given: Daniele

family: Francon

full_name: Daniel Francon

given: Daniel

family: Leblanc

full_name: Eric Leblanc

given: Eric

family: Lambaudie

full_name: Eric Lambaudie

journal_name: Gynecologic Oncology

location_facility: Institut de Cancérologie de l'Ouest Site René Gauducheau


title: Detection of Arousal With Facial Micro-expression in Severe Brain-damaged Patient

acronym: DAME

summary: Severe brain injuries lead to disorders of consciousness after coma. During this awakening period, detection of arousal is critical to the adaptation of medical strategy, but global paralysis, including facial expression, make the clinical assessment very difficult. Emotional facial expressions are a significant part of this clinical assessment. They are both a landmark of the internal state of the patient (comfort versus discomfort) and a landmark of the relational level with his environment. Visible emotional facial expression is a large temporal phenomenon lasting a couple of seconds, while a microexpression is barely noticeable and very brief. These micro expressions are usually produced when one tried to voluntary hide emotional expressions. In this study, we hypothesize that some patients awakening from coma could still produce microexpression before being able to produce visible emotional facial expressions. This ability to produce micro-expression could be an early landmark of relational awakening in severe brain lesions.

location_facility:
Clinique Mutualiste Saint Etienne
Chu Saint-Etienne


title: Can we Define a Clinical Score for Predicting of Hypofibrinogenemia in Severe Trauma

summary: In this retrospective and prospective study, the aim is to determine a score for predicting a fibrinogen <1.5g/L (corresponding to European threshold of Directors recommendations of fibrinogen concentrates)

lead_sponsor: Hospices Civils de Lyon

location_facility:
HEH - Hospices Civils de Lyon
CHLS, Hospices Civils de Lyon


title: Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents

acronym: STELLASUPERA

summary:
Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal lesions. This technique tends to extend to lesions for which the gold standard remains until now the open surgery treatment (lesions TASC C and D).

The primary objective of the study was to evaluate the clinical efficacy at 12 months of the SuperA stent (Abbott) in the treatment of long de novo atherosclerotic lesions TASC C and D in patients with symptomatic peripheral arterial disease. The secondary objectives are to evaluate the clinical effectiveness of the SuperA stent at 24 months, according to clinical, morphological and haemodynamic criteria, the possible influence of calcifications and the quality of life of patients.

The SuperA stent treatment is not specifically provided for by the Protocol but is carried out within the framework of the care. This study is an observationnal study.

lead_sponsor: Nantes University Hospital

location_facility:
Nantes CHU
CHD Vendée


acronym: ARAMIS

location_facility: ACTION Study Group - Department of Cardiology - Pitié Salpétrière Hospital, 47 Bd de l'Hopital

location_facility: Department of internal medicine - Pitié Salpétrière Hospital, 47 Bd de l'Hopital

source: euctr

title: Anakinra Versus Placebo Double Blind Randomized Controlled Trial for the Treatment of Acute MyocarditIS

summary:
There is no specific treatment of acute myocarditis, especially during the inflammatory period. Interleukin (IL) is specifically involved during this period and play a role in myocardial oedema. ANAKINRA, an IL-1β Blocker, is a new treatment that has never been evaluated in myocarditis. The benefit for the patient could be important with a reduction of heart failure and ventricular arrhythmias.

Hypothesis : ANAKINRA in addition to standard therapy for treatment of Acute Myocarditis is superior to standard therapy based on an association of beta-blockers and Angiotensin-Converting-Enzyme inhibitor (ACE).


title: Impact of CT Scan and Lung Ultrasonogrpahy in Early Diagnostic Accuracy for Ventilation Acquired Lower Respiratory Tract Infections in Intensive Care Units.

acronym: ECTOPICUS

summary:
We aim to show that systematic ultrasonography performed in ventilated patients suspected of ventilation-acquired pneumonia could improve the accuracy of diagnostic of pneumonia, and helps defining the diagnostic of tracheobronchitis when lower respiratory tract infection is considered.

Chest CT scan is often performed before or just after admission in ICU, and usually show abnormalities that are revealed later on standard radiographs.

This last exam is traditionally considered as the gold standard to prove new pulmonary infiltrates, but the correlation with parenchymal consolidation is pretty low, and lead to over-diagnosing pneumonia, thus leading to a massive and maybe sometimes unconsidered prescription of antibiotic therapy.

Lung ultrasonography conducted systematically within the 3 first days after suspcion of pneumonia could help making the difference between real infection-linked lesions, and banal abnormalities following the hydric inflation of intra-thoracic organs, for instance pulmonary edema or pleural effusion.

An independent evaluation using lung ultrasound, and analysis of CT scan acquisition when performed, compared with the physician in charge of the patient appreciation by suggesting him to provide his own probability of pneumonia upon routine clinical and biological datas.

ReferenceType: result

ReferenceCitation: Haddam M, Zieleskiewicz L, Perbet S, Baldovini A, Guervilly C, Arbelot C, Noel A, Vigne C, Hammad E, Antonini F, Lehingue S, Peytel E, Lu Q, Bouhemad B, Golmard JL, Langeron O, Martin C, Muller L, Rouby JJ, Constantin JM, Papazian L, Leone M; CAR'Echo Collaborative Network; AzuRea Collaborative Network. Lung ultrasonography for assessment of oxygenation response to prone position ventilation in ARDS. Intensive Care Med. 2016 Oct;42(10):1546-1556. doi: 10.1007/s00134-016-4411-7. Epub 2016 Jun 20.

family: Haddam

full_name: Malik Haddam

given: Malik

family: Zieleskiewicz

full_name: Laurent Zieleskiewicz

given: Laurent

family: Perbet

full_name: Sebastien Perbet

given: Sebastien

family: Baldovini

full_name: Alice Baldovini

given: Alice

family: Guervilly

full_name: Christophe Guervilly

given: Christophe

family: Arbelot

full_name: Charlotte Arbelot

given: Charlotte

family: Noel

full_name: Alexandre Noel

given: Alexandre

family: Vigne

full_name: Coralie Vigne

given: Coralie

family: Hammad

full_name: Emmanuelle Hammad

given: Emmanuelle

family: Antonini

full_name: François Antonini

family: Lehingue

full_name: Samuel Lehingue

given: Samuel

family: Peytel

full_name: Eric Peytel

family: Lu

full_name: Qin Lu

given: Qin

family: Bouhemad

full_name: Belaid Bouhemad

given: Belaid

family: Golmard

full_name: Jean-Louis Golmard

given: Jean-Louis

family: Langeron

full_name: Olivier Langeron

given: Olivier

family: Martin

full_name: Claude Martin

given: Claude

family: Muller

full_name: Laurent Muller

family: Rouby

full_name: Jean-Jacques Rouby

given: Jean-Jacques

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

family: Papazian

full_name: Laurent Papazian

family: Leone

full_name: Marc Leone

given: Marc

ReferenceCitation: Mongodi S, Via G, Girard M, Rouquette I, Misset B, Braschi A, Mojoli F, Bouhemad B. Lung Ultrasound for Early Diagnosis of Ventilator-Associated Pneumonia. Chest. 2016 Apr;149(4):969-80. doi: 10.1016/j.chest.2015.12.012. Epub 2015 Dec 22.

ReferenceCitation: Martin-Loeches I, Povoa P, Rodríguez A, Curcio D, Suarez D, Mira JP, Cordero ML, Lepecq R, Girault C, Candeias C, Seguin P, Paulino C, Messika J, Castro AG, Valles J, Coelho L, Rabello L, Lisboa T, Collins D, Torres A, Salluh J, Nseir S; TAVeM study. Incidence and prognosis of ventilator-associated tracheobronchitis (TAVeM): a multicentre, prospective, observational study. Lancet Respir Med. 2015 Nov;3(11):859-68. doi: 10.1016/S2213-2600(15)00326-4. Epub 2015 Oct 22.

ReferenceCitation: Claessens YE, Debray MP, Tubach F, Brun AL, Rammaert B, Hausfater P, Naccache JM, Ray P, Choquet C, Carette MF, Mayaud C, Leport C, Duval X. Early Chest Computed Tomography Scan to Assist Diagnosis and Guide Treatment Decision for Suspected Community-acquired Pneumonia. Am J Respir Crit Care Med. 2015 Oct 15;192(8):974-82. doi: 10.1164/rccm.201501-0017OC.

journal_name: American Journal of Respiratory and Critical Care Medicine

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Hôpital Bichat - Claude Bernard
Hôpital Universitaire Jean Minjoz


title: Prospective Biobanking Study in Ovarian, Breast and Head and Neck Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response

acronym: SCANDARE

summary: SCANDARE is a prospective biobanking study on tumor (+/- nodes), plasma and blood samples at different time points in ovarian, triple negative breast and head and neck cancer patients. This study will allowed to identify new molecular and/or immunological biomarkers associated with clinical and biological features of the tumors. All patients will receive standard treatment according to the stage of the diseases and usual procédures.

lead_sponsor: Institut Curie

location_facility:
Institut Curie Hopital Rene Huguenin
Institut Curie


title: Descriptional Study of the Side Effects Related to the Use of the Interface in Home Care Patients Treated for at Least 3 Months by Continuous Positive Pressure or Non-Invasive Ventilation.

acronym: InterfaceVent

summary:
Home ventilation techniques consist mainly of two techniques, Continuous Positive Airway Pressure or CPAP and Non Invasive Ventilation or NIV. Whether for CPAP or NIV, pressures are delivered to the patient via an interface.

The efficacy of CPAP and NIV is conditioned in part by the observance of the patients to the device. Because the comfort and degree of satisfaction of the patients to its interface is a key factor of the observance, side-effects and satisfaction of patients need to be continuously evaluated with available interfaces for CPAP and NIV treated patients.

The purpose of the research is the evaluation of interface side-effects and the degree of satisfaction of home care patients treated for at least three months with CPAP or NIV.

ReferenceCitation: Rotty MC, Mallet JP, Suehs CM, Martinez C, Borel JC, Rabec C, Bourdin A, Molinari N, Jaffuel D. Is the 2013 American Thoracic Society CPAP-tracking system algorithm useful for managing non-adherence in long-term CPAP-treated patients? Respir Res. 2019 Sep 12;20(1):209. doi: 10.1186/s12931-019-1150-7.

family: Rotty

full_name: Marie-Caroline Rotty

given: Marie-Caroline

family: Mallet

full_name: Jean-Pierre Mallet

given: Jean-Pierre

family: Suehs

full_name: Carey M. Suehs

given: Carey M.

family: Martinez

full_name: Christian Martinez

given: Christian

family: Borel

full_name: Jean-Christian Borel

given: Jean-Christian

family: Rabec

full_name: Claudio Rabec

given: Claudio

family: Bourdin

full_name: Arnaud Bourdin

given: Arnaud

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

family: Jaffuel

full_name: Dany Jaffuel

given: Dany

journal_name: Respiratory Research

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

ReferenceCitation: Rotty MC, Suehs CM, Mallet JP, Martinez C, Borel JC, Rabec C, Bertelli F, Bourdin A, Molinari N, Jaffuel D. Mask side-effects in long-term CPAP-patients impact adherence and sleepiness: the InterfaceVent real-life study. Respir Res. 2021 Jan 15;22(1):17. doi: 10.1186/s12931-021-01618-x.

location_facility: Centre Hospitalier Universitaire de Montpellier


title: Impact of Preoperative 4-week Supplementation With Omega-3 Polyunsaturated Fatty Acids on Liver Volume and Steatosis to Facilitate Bariatric Surgery in Morbdly Obese Patients : the " Omegaobese Study ".

acronym: Omegobese

summary:
Hepatomegaly is common in the morbidly obese patients and it may hamper the access to the hiatal region during bariatric surgery. The doctors made a preliminary prospective study that showed that a preoperative 4-week course of 1.500 Mg/ day without caloric restriction resulted in a 20 % reduction in the volume of the left liver lobe (segment 2 and 3) on ultrasounds.

The aim of this study is to determine whether a 4-week preoperative course with omega-3 without caloric restriction (1650 mg of omega-3 / day for 4 weeks) may reduce liver volume and its fat content, rendering thus surgery easier.

The primary end point is the reduction of the volume of the left liver lobe as measured by magnetic resonance imaging.

Secondary end points are: the reduction of the whole liver volume, liver steatosis, liver injuries during surgery, and duration of surgery, the evolution of liver tests as well as the correlation between preoperative MRI data and intraoperative liver biopsy for the quantification of liver steatosis.

Study design: This is an interventional, prospective, multicentric, randomized, double blinded clinical trial. Morbidly obese patients with metabolic syndrome candidate to bariatric surgery fulfilling criteria for bariatric surgery as established by the Haute Autorité de Santé are elegible for the study. Number of subjects to be enrolled: 44 patients in 12 months.

Study time schedule: At the time of the enrollment visit two visits are scheduled, the first before the beginning of the study and the last at the end. Surgery is scheduled no more than 7 days after the end of the treatment. At time of these two visits a clinical examination is performed avec calculation of the BMI, blood tests (ASAT, ALAT; GGT, total, HDL and LDL cholesterol, triglycerides, glycemia, C-peptide, HbA1c, insulin, HOMA-IR, C reactive protein) and a MRI to evaluate the volume and the fat content of the liver. At time of surgery duration of surgery and any eventual liver injury are recorded and a liver biopsy is performed.

The hypothesis is that, as shown by the preliminary study, the omega-3, will result in a reduction in the volume of the left liver lobe of 20 %.

Conclusion: If a 4-week preoperative course of omega-3 without caloric restriction results in a significant reduction of liver volume and steatosis before bariatric surgery, it may be recommended as a systematic preoperative treatment.

location_facility: CHU de Montpellier - Chirurgie digestive

location_facility: CHU de Nice - Chirurgie Digestive- Hôpital Archet


title: A Randomized, Multicenter, Phase III Trial Comparing Induction CT With Docetaxel, Cisplatin and 5-FU (TPF) Followed by Concurrent CT-RT to Concurrent CT Alone, in Nasopharyngeal Cancers Staged as T2b, T3, T4 and/or With Lymph Node Involvement (>N1)

summary: This is a randomized, multicenter, phase III trial comparing induction chemotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy to concurrent chemoradiotherapy alone, in nasopharyngeal cancers staged as T2b, T3, T4 and/or with lymph node involvement (≥ N1. The main end point is the event free survival.

ReferenceCitation: Tao Y, Aupérin A, Graff P, Lapeyre M, Grégoire V, Maingon P, Geoffrois L, Verrelle P, Calais G, Gery B, Martin L, Alfonsi M, Deprez P, Bardet E, Pignon T, Rives M, Sire C, Bourhis J. Very accelerated radiotherapy or concurrent chemoradiotherapy for N3 head and neck squamous cell carcinoma: Pooled analysis of two GORTEC randomized trials. Oral Oncol. 2017 Aug;71:61-66. doi: 10.1016/j.oraloncology.2017.06.002. Epub 2017 Jun 9.

family: Tao

full_name: Yungan Tao

given: Yungan

family: Aupérin

full_name: Anne Aupérin

given: Anne

family: Graff

full_name: Pierre Graff

given: Pierre

family: Lapeyre

full_name: Michel Lapeyre

given: Michel

family: Grégoire

full_name: Vincent Grégoire

given: Vincent

family: Maingon

full_name: Philippe Maingon

given: Philippe

family: Geoffrois

full_name: Lionel Geoffrois

given: Lionel

family: Verrelle

full_name: Pierre Verrelle

family: Calais

full_name: Gilles Calais

given: Gilles

family: Gery

full_name: Bernard Gery

given: Bernard

full_name: Laurent Martin

given: Laurent

family: Alfonsi

full_name: Marc Alfonsi

family: Deprez

full_name: Patrick Deprez

given: Patrick

family: Bardet

full_name: Etienne Bardet

given: Etienne

family: Pignon

full_name: Thierry Pignon

given: Thierry

family: Rives

full_name: Michel Rives

family: Sire

full_name: Christian Sire

family: Bourhis

full_name: Jean Bourhis

given: Jean

journal_name: Oral Oncology

ReferenceCitation: Bourhis J, Sire C, Graff P, Grégoire V, Maingon P, Calais G, Gery B, Martin L, Alfonsi M, Desprez P, Pignon T, Bardet E, Rives M, Geoffrois L, Daly-Schveitzer N, Sen S, Tuchais C, Dupuis O, Guerif S, Lapeyre M, Favrel V, Hamoir M, Lusinchi A, Temam S, Pinna A, Tao YG, Blanchard P, Aupérin A. Concomitant chemoradiotherapy versus acceleration of radiotherapy with or without concomitant chemotherapy in locally advanced head and neck carcinoma (GORTEC 99-02): an open-label phase 3 randomised trial. Lancet Oncol. 2012 Feb;13(2):145-53. doi: 10.1016/S1470-2045(11)70346-1. Epub 2012 Jan 18.

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_facility:
University of Cluj
Hôpital Habib Bourguiba
Hôpital de la Pitié-Salpétrière
University of Casablanca
Institut Gustave Roussy


title: Molecular Signature From Tumor to Lymph Nodes: How to Identify the Right Candidate for IIIA-N2 Lung Cancer Surgery?

summary:
Mediastinal lymph node (LN) involvement (N2) in non-small cell lung cancer (NSCLC) concerns 15% of resectable tumors and is associated with a poor prognosis and an overall survival reaching 9 to 49%. Literature fails to provide any definitive consensus regarding the management of these patients, except for the platinum-based doublet chemotherapy. The N2 involvement remains a matter of debate because of its not yet well-classified heterogeneity. Regarding anatomy, the Mountain and Dresler's regional LN classification for lung cancer staging remains the reference. Different studies classified IIIA-N2 disease into 4 groups, in addition to the skip-N2 phenomenon: minimal-N2, N2 single station, N2 multiple stations, and bulky-N2. Other subgroups were recently proposed for the 8th edition of the TNM: N2a1 - single station skip, N2a2 - single station non-skip, N2b - multiple stations.

The French National Cancer Institute (INCa) proposed guidelines, but in case of cN2 staging without mediastinal infiltration, guidelines remained imprecise ("resectability should be discussed for each case") and suggested surgery first, or induction chemotherapy, or concomitant chemoradiation.

Thus, optimal management of cIIIA-N2 remains controversial but complete tumor resection can be related to long-term survival in some patients, including 10 years after surgery [1]. In this situation, the identification of markers that will help select IIIA-N2 patients who will benefit from surgical resection is mandatory.

status: Not yet recruiting

time_perspective: Cross-Sectional

ReferenceCitation: Altman DG, McShane LM, Sauerbrei W, Taube SE. Reporting recommendations for tumor marker prognostic studies (REMARK): explanation and elaboration. BMC Med. 2012 May 29;10:51. doi: 10.1186/1741-7015-10-51.

ReferenceCitation: Legras A, Mordant P, Arame A, Foucault C, Dujon A, Le Pimpec Barthes F, Riquet M. Long-term survival of patients with pN2 lung cancer according to the pattern of lymphatic spread. Ann Thorac Surg. 2014 Apr;97(4):1156-62. doi: 10.1016/j.athoracsur.2013.12.047. Epub 2014 Feb 26.

ReferenceCitation: Lin IF, Chang WP, Liao YN. Shrinkage methods enhanced the accuracy of parameter estimation using Cox models with small number of events. J Clin Epidemiol. 2013 Jul;66(7):743-51. doi: 10.1016/j.jclinepi.2013.02.002. Epub 2013 Apr 6.

ReferenceCitation: Pécuchet N, Rozenholc Y, Zonta E, Pietrasz D, Didelot A, Combe P, Gibault L, Bachet JB, Taly V, Fabre E, Blons H, Laurent-Puig P. Analysis of Base-Position Error Rate of Next-Generation Sequencing to Detect Tumor Mutations in Circulating DNA. Clin Chem. 2016 Nov;62(11):1492-1503. Epub 2016 Sep 13.

ReferenceCitation: Peduzzi P, Concato J, Feinstein AR, Holford TR. Importance of events per independent variable in proportional hazards regression analysis. II. Accuracy and precision of regression estimates. J Clin Epidemiol. 1995 Dec;48(12):1503-10.

ReferenceCitation: Tapak L, Saidijam M, Sadeghifar M, Poorolajal J, Mahjub H. Competing risks data analysis with high-dimensional covariates: an application in bladder cancer. Genomics Proteomics Bioinformatics. 2015 Jun;13(3):169-76. doi: 10.1016/j.gpb.2015.04.001. Epub 2015 Apr 20.

ReferenceCitation: Um SW, Joung JG, Lee H, Kim H, Kim KT, Park J, Hayes DN, Park WY. Molecular Evolution Patterns in Metastatic Lymph Nodes Reflect the Differential Treatment Response of Advanced Primary Lung Cancer. Cancer Res. 2016 Nov 15;76(22):6568-6576. doi: 10.1158/0008-5472.CAN-16-0873. Epub 2016 Sep 13.

ReferenceCitation: Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007 Mar 15;165(6):710-8. Epub 2006 Dec 20.

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: Hôpital du Haut-Lévêque, CHU de Bordeaux


lead_sponsor: Guerbet

location_facility:
CHU Angers
Hôpital Beaujon

title: Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis, Phase IIa Clinical Study

summary: This study is an exploratory study aiming to collect data about diagnosis efficacy (sensitivity and specificity) of P03277 triphasic liver imaging for HCC in subjects with suspected small nodules and chronic liver disease. 30 subjects will be included, having HCC confirmed or not by previous enhanced CT and/or MRI and before any biopsy for histology analysis. The standard of reference for diagnosis will be given by the site according to their standard of care and adapted from EASL/EORTC diagnostic criteria (considering previous contrast enhanced imaging (CT and/or MRI) and/or biopsy specimen analysis given on-site and/or the more recent AFP results available). 10 additional subjects will be included to explore the diagnostic efficacy for HCC at half dose of P03277.


title: CARIM Cohort (CARdioprotection in Myocardial Infarction)

acronym: CARIM

summary: CARIM is a prospective cohort of 2,000 patients with a first myocardial infarction and undergoing reperfusion therapy. Therefore, male and female patients older than 18 years and younger than 90 years with onset of chest pain of less than 12 hours who need a primary percutaneous coronary intervention (PCI) for a ST elevation segment MI (STEMI) will be recruited.

lead_sponsor: EZUS-LYON 1

location_facility:
Hôpital Mondor
CHRU de Tours


title: Etude de Génétique moléculaire du Syndrome de Mayer-Rokitansky-Kuster-Hauser

acronym: MRKH

summary:
In order to understand the molecular mechanisms leading to Mayer-Rokitansky-Kuster-Hauser syndrome (MRKH), the research team has to identify molecular bases of this anomaly.

Toward this goal, the research team would like to include in the study patients with MRKH syndrome, as well as their healthy relatives, in order to perform genetic analyses, especially whole exome sequencing.

This study has been set up in order to collect biological samples from patients with MRKH and their relatives.

lead_sponsor: Imagine Institute

location_facility:
Necker - Enfants malades hospital
Institut Mutualiste Montsouris

intervention_type: Genetic


title: Erythrocyte Transfusion Based on the Measurement of Central Venous Oxygen Saturation in Postoperative Cardiac Surgery: a Bicentric, Prospective Randomized Study

acronym: PITT

summary: Postoperative erythrocytes transfusion is associated with morbidity and excess mortality, which should lead to ask the indication for RBC transfusions only on metabolic needs. Currently, the majority of studies used to put hemoglobin values indicating red cell transfusions. Two observational studies have confirmed that a transfusion strategy based on a metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than using the hemoglobin threshold values. We propose to conduct the first randomized multicenter study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the ScvO2 each patient versus a threshold value usually recommended for all patients.

ReferenceCitation: Fischer MO, Guinot PG, Debroczi S, Huette P, Beyls C, Babatasi G, Bafi K, Guilbart M, Caus T, Lorne E, Dupont H, Hanouz JL, Diouf M, Abou-Arab O. Individualised or liberal red blood cell transfusion after cardiac surgery: a randomised controlled trial. Br J Anaesth. 2021 Nov 30. pii: S0007-0912(21)00650-4. doi: 10.1016/j.bja.2021.09.037. [Epub ahead of print]

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Amiens Picardie
Caen


title: Periodontal Impact of Eating Disorders (the PERIOED Study)

acronym: PERIOED

summary: This study evaluated the periodontal status of patients suffering from eating disorders (anorexia nervosa and bulimia nervosa). The work hypothesis is that eating disorder patients have a higher risk for periodontal diseases than non-eating disorder subjects.

ipd_sharing_description: IPD will be available on request.

lead_sponsor: University Paris 7 - Denis Diderot

location_facility:
Paul Brousse Hospital
Rothschild Hospital


title: EVALUATION DE LA TOMOSYNTHESE DANS LA CARACTERISATION ET LA PRISE EN CHARGE DES LESIONS MAMMAIRES : "ETOLE"

acronym: ETOLE

summary:
Tomosynthesis is an innovative technique developed in digital mammography for obtaining a sectional image of the breast. Mammography has the main disadvantage of being an imaging projection that creates overlays, which eliminates tomosynthesis.

The objective of this study is to evaluate if the BI-RADS classification obtained by tomosynthesis with synthetic mammography is superior to that obtained by conventional mammography in terms of specificity while not inferior in terms of sensitivity.

location_facility:
Hopital Tenon
hopital Saint-Louis


title: Incidence of Sacro-Iliac Joint Anomalies on MRI in Women Aged From 18 to 50 Years Old

acronym: MISIA

summary:
Prospective multicenter study assessing the incidence of inflammatory and structural lesions seen on MRI of the SI joints in a consecutive population of women aged 18-50 years old.

The study hypothesis is SpA may be misdiagnosed on MRI in post partum women due to increased stress on the joint following pregnancy and childbirth, as MRI of the SI joints may show lesions that could mimics axial spondyloarthritis. The primary objective of this study is to determine the incidence of SI lesions seen at MRI in women. The secondary objectives are to compare the incidence and pattern of MRI inflammatory and structural lesions of the SI joints and to determine the factors associated with inflammatory or structural changes of the SI joints in a population of women. the investigators will especially compare the population of women within a year after childbirth versus the population of women who never gave birth or who gave birth over 24 months ago or more.

ReferenceCitation: Hoballah A, Lukas C, Leplat C, Taourel P, Pialat JB, Sans N, Ramos-Pascual S, Cyteval C. MRI of sacroiliac joints for the diagnosis of axial SpA: prevalence of inflammatory and structural lesions in nulliparous, early postpartum and late postpartum women. Ann Rheum Dis. 2020 Aug;79(8):1063-1069. doi: 10.1136/annrheumdis-2020-217208. Epub 2020 Jun 10.

family: Hoballah

full_name: Adel Hoballah

given: Adel

family: Lukas

full_name: Cédric Lukas

given: Cédric

family: Leplat

full_name: Christophe Leplat

given: Christophe

family: Taourel

full_name: Patrice Taourel

given: Patrice

family: Pialat

full_name: Jean-Baptiste Pialat

given: Jean-Baptiste

family: Sans

full_name: Nicolas Sans

family: Ramos-Pascual

full_name: Sonia Ramos-Pascual

given: Sonia

family: Cyteval

full_name: Catherine Cyteval

given: Catherine

journal_name: Annals of the Rheumatic Diseases

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: University Hospital, Montpellier


title: Incidence of Acute Renal Failure Associated With Iodinated Contrast Agents in Pediatrics. Study CANOPY. Prospective Multicenter Study

acronym: CANOPY

summary:
Iodinated contrast media are now frequently used in diagnostic imaging exams, including pediatrics.

In adults, the acute renal failure (ARF) associated with contrast agents (CA-AKI) occur in 3-33% of exposed patients, especially as the patient is fragile, has comorbidities or pre-existing renal aggression .

In children, the prevalence of this little known disease is probably underestimated.

The investigators intend to conduct a prospective epidemiological study, to estimate the impact of the acute renale failure to iodinated contrast agents in pediatrics.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de Lyon
Chu Saint-Etienne


title: Identification of Markers (Klotho-FGF23 Axis) as Determinant in the Evolution of Arterial Stiffness During the First Year of Renal Transplant

acronym: KLOTHO

summary: The primary objective is to show that the contribution of Klotho by the renal graft is an independent determinant of the evolution of the recipient's central arterial stiffness during the first year of renal transplant. The contribution of Klotho by the graft will be estimated by: its circulating concentrations assay, its urinary excretion assay, and, indirectly, by the circulating concentrations of FGF23. The recipient's central arterial stiffness will be estimated by the measure of the carotid-femoral pulse wave velocity, noninvasive reference method for measuring aortic stiffness in human.

lead_sponsor: Hopital Foch

location_facility:
AH-HP Hôpital Necker enfants malades
Hôpital Foch


title: Genetic, Neurophysiological and Psychological Predictive Factors of Chronic Neuropathic Pain After Surgery for Breast Cancer

acronym: DOLORISKSEIN

summary: The aim of the study is to establish the genetic, neurophysiological and psychological phenotype of the patients presenting a persistent neuropathic pain after surgery of the breast cancer, by comparing the neuropathic painful patients with the not painful and with the not neuropathic painful . This will be realized on a transverse cohort ("Seintinelle"cohort) and confirmed on a forward-looking longitudinal cohort.

status: Withdrawn

location_facility:
Centre René Huguenin
Hopital Ambroise Paré


title: Prospective Non-interventional, Prospective Multicenter Study of VEGA System® Prosthesis in the Total Knee Arthroplasty

summary: This post-market clinical follow-up study intends to investigate long-term functionality of the VEGA System®. The design of the VEGA System® is meant to provide the patient with more knee mobility compared to their pre-operative state.The endpoint is the revision of at least one of the prosthesis components

lead_sponsor: BBraun Medical SAS

location_facility: Hôpital Privé des Bonnettes-Service de Chirurgie Orthopédique et Traumatologie

location_facility: Hôpital Lariboisière- Service de Chirurgie Orthopédique et Traumatologie


title: Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines: Multicenter, Randomized Controlled Trial (NUTRIREA-2)

summary: The purpose of this study is to assess the hypothesis that, as compared to early intravenous feeding, early nutrition via the enteral route is associated with reduced Day 28-mortality in critically ill patients treated with mechanical ventilation and vasoactive drug.

ReferenceCitation: Reignier J, Boisramé-Helms J, Brisard L, Lascarrou JB, Ait Hssain A, Anguel N, Argaud L, Asehnoune K, Asfar P, Bellec F, Botoc V, Bretagnol A, Bui HN, Canet E, Da Silva D, Darmon M, Das V, Devaquet J, Djibre M, Ganster F, Garrouste-Orgeas M, Gaudry S, Gontier O, Guérin C, Guidet B, Guitton C, Herbrecht JE, Lacherade JC, Letocart P, Martino F, Maxime V, Mercier E, Mira JP, Nseir S, Piton G, Quenot JP, Richecoeur J, Rigaud JP, Robert R, Rolin N, Schwebel C, Sirodot M, Tinturier F, Thévenin D, Giraudeau B, Le Gouge A; NUTRIREA-2 Trial Investigators; Clinical Research in Intensive Care and Sepsis (CRICS) group. Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2). Lancet. 2018 Jan 13;391(10116):133-143. doi: 10.1016/S0140-6736(17)32146-3. Epub 2017 Nov 8.

family: Reignier

full_name: Jean Reignier

family: Boisramé-Helms

full_name: Julie Boisramé-Helms

given: Julie

family: Brisard

full_name: Laurent Brisard

family: Lascarrou

full_name: Jean-Baptiste Lascarrou

family: Ait Hssain

full_name: Ali Ait Hssain

given: Ali

family: Anguel

full_name: Nadia Anguel

given: Nadia

family: Argaud

full_name: Laurent Argaud

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Asfar

full_name: Pierre Asfar

given: Pierre

family: Bellec

full_name: Frédéric Bellec

given: Frédéric

family: Botoc

full_name: Vlad Botoc

given: Vlad

family: Bretagnol

full_name: Anne Bretagnol

given: Anne

family: Bui

full_name: Hoang-Nam Bui

given: Hoang-Nam

family: Canet

full_name: Emmanuel Canet

given: Emmanuel

family: Da Silva

full_name: Daniel Da Silva

given: Daniel

family: Darmon

full_name: Michael Darmon

given: Michael

family: Das

full_name: Vincent Das

given: Vincent

family: Devaquet

full_name: Jérôme Devaquet

given: Jérôme

family: Djibre

full_name: Michel Djibre

given: Michel

family: Ganster

full_name: Frédérique Ganster

given: Frédérique

family: Garrouste-Orgeas

full_name: Maité Garrouste-Orgeas

given: Maité

family: Gaudry

full_name: Stéphane Gaudry

given: Stéphane

family: Gontier

full_name: Olivier Gontier

given: Olivier

family: Guérin

ReferenceCitation: Brisard L, Le Gouge A, Lascarrou JB, Dupont H, Asfar P, Sirodot M, Piton G, Bui HN, Gontier O, Hssain AA, Gaudry S, Rigaud JP, Quenot JP, Maxime V, Schwebel C, Thévenin D, Nseir S, Parmentier E, El Kalioubie A, Jourdain M, Leray V, Rolin N, Bellec F, Das V, Ganster F, Guitton C, Asehnoune K, Bretagnol A, Anguel N, Mira JP, Canet E, Guidet B, Djibre M, Misset B, Robert R, Martino F, Letocart P, Silva D, Darmon M, Botoc V, Herbrecht JE, Meziani F, Devaquet J, Mercier E, Richecoeur J, Martin S, Gréau E, Giraudeau B, Reignier J. Impact of early enteral versus parenteral nutrition on mortality in patients requiring mechanical ventilation and catecholamines: study protocol for a randomized controlled trial (NUTRIREA-2). Trials. 2014 Dec 23;15:507. doi: 10.1186/1745-6215-15-507.

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil

location_facility: CHU de Strasbourg - Hôpital de Hautepierre


title: Tolerance of a Motorized Orthosis Reproducing Walking Movement Versus Conventional Passive Standing-up Devices in Children With Cerebral Palsy : A Non-inferiority, Randomised, Multicenter, Controlled Trial

acronym: EOMEC/CP

summary:
Cerebral palsy (CP) includes all the sensorimotor development disorders leading to balance, gait and movement disruptions. These disorders are related to lesions of the central nervous system (CNS) that occurs at birth or during the early childhood. The therapeutic management of CP is essentially based on reeducation, but may also require specific medical treatments, orthopedic devices and sometimes bone surgery. Therefore, CP children are very often placed in specialized institutions with a significant socioeconomic impact. CP children suffer from various sensorimotor impairments, which may evolve into orthopedic deformations, justifying the implementation of restrictive devices. The French High Authority of Health (HAS) estimates that 50 % of CP children have pains when using contention or verticalization devices. These pains are mainly nociceptive and are caused by the passive constraint applied on contact points. Many clinical trials evaluating the physiotherapy benefits on CP patients have led to controversial results regarding the duration of the effect of this therapeutic approach. However, the improvement is more important when neuromuscular facilitation techniques are added to the reeducation program. Human neuronal adaptation and plasticity mechanisms are now understood, with the possibility of a potential partial recovery. Non-invasive stimulation methods and neurorehabilitation techniques could participate in the CNS re-calibration. Automated assisted movements have already been used and these processes showed an increase joint range of motion, bone density and decreased spasticity.

In recent years, "exoskeleton" devices have been used on subjects with spinal cord injuries allowing motor performances improvement.

This pilot study aims evaluating CP children's tolerance to motorized orthosis reproducing walking pattern compared with conventional passive standing-up devices. For this clinical trial, the investigators compare the behavior of CP children using a motorized orthosis reproducing walking pattern (Innowalk Pro Small) to the behavior of same children placed in their usual conventional passive device. The investigators hypothesis is that the Innowalk improves joints range of motion, enhances selective motor control, decreases the medium-term spasticity and offers at least the same tolerance as conventional passive devices.

primary_purpose: Supportive Care

lead_sponsor: Lille Catholic University

location_facility:
IEM Ellen Poidatz
IEM Sévigné
IEM Vent de Bise
IEM Christian Dabbadie


title: Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation

acronym: OPTION

summary: The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
Netherlands
Germany
France
Poland
Belgium
Australia
Spain
Denmark
United States

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

location_facility: Cardiovascular Associates of the Delaware Valley

location_facility: St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH

location_facility: Kaiser Permanente Santa Clara Medical Center

location_facility: University of Southern California Hospital

location_facility: Medical Center of the Rockies (Loveland)

location_facility: University Berlin, Charite Virchow Standort, Wedding

location_facility: University Hospital of Lord's Transfiguration

location_facility: Presbyterian University of Pennsylvania Medical Center

location_facility: Gornoslaskie Centrum Medyczne im. Prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach Ziolow

location_facility: Christus Trinity Mother Frances Health System

location_facility: Lindner Center for Research and Education at Christ Hospital

location_facility: OhioHealth Research and Innovation Institute - Riverside Methodist Hospital


title: Randomized Study Comparing Sentinel Node (SN) Policy to Current French Initial Staging Protocols in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence

acronym: SENTIRAD

summary: The aim of this study is to evaluate the sentinel node policy in early stage endometrial carcinomas at intermediate and high risk of recurrence (by comparing the sentinel node policy to current initial staging protocols).

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Hospitalier Régional Universitaire

location_facility: Institut de Cancérologie de l'Ouest, René Gauducheau


title: Open Label Assessment of VistaCare® Treatment in Current Medical Practice in Patients With Acute and Chronic Leg Wounds.

summary: Assessment of the safety and performance of the VistaCare® medical device in current medical practice in the treatment of acute and chronic lower limb wounds.

lead_sponsor: DTAMedical SAS

location_facility:
Hôpital La Timone
CHU de Nantes Centre des Brûlés
CHU Henri Mondor
Hôpital de la Conception


title: Pilot Study of the Effect on the Retinal Sensitivity of the Membrane Blue Dual® Dye Used for Peeling of the Internal Limiting Membrane in Macular Hole Surgery

acronym: MICROCOL

summary:
The idiopathic macular hole, age-related disease, is a major cause of vision loss and affects at least two persons in 1000 after 40 years.

This hole causes an acute decline linked to a central scotoma. The only treatment is surgical. The surgery involves removing the posterior hyaloid (vitreous base) to relieve the tensile forces. To be sure the removed is complete and to facilitate the closure of the hole, a peeling of the internal limiting, the outermost layer of the retina, is often suggested. The inner limiting membrane (ILM), transparent and adherent to the retina, is colored with vital dyes to facilitate its removal. After closure of the macular hole, the central scotoma disappears but a diffuse and asymptomatic loss of pericentral sensitivity is often described. This sensitivity decrease could be induced by the dyes used during surgery.

This effect has not been studied clinically for recent dyes (Membrane Blue Dual®, Brilliant Blue®, Acid Violet®) at the concentrations used, but is known in electrophysiology at higher concentrations, at least on the isolated retina models.

It would be interesting to search for a decrease in retinal peri-foveal postoperative sensitivity after surgery of macular holes, performed with the usual dyes. Only microperimetry can observe this decrease in retinal sensitivity. This is a noninvasive technique that explores the macular visual field. It is performed without iris dilatation and allows an automatic exploration ensuring rapid and accurate analysis of retinal sensitivity.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rotchschild


title: The Process of Sensory Anticipation in Patients With PARKINSON's Disease

acronym: IDEOMOT

summary: The ideomotor theory of action control is considered to be central to the understanding of human voluntary action. According to the ideomotor theory, an action is represented in terms of its desired sensory effects and actions are selected by internally activating these effect representations. Recent imagery and behavioral studies showed that this anticipated representation of action-effects triggered a "sensory attenuation", meaning a decrease of perceptive performances or a decrease of sensory event-related potentials (ERP) for an expected event. Thus, the sensory attenuation constitutes a relevant behavioral tool to investigate sensory anticipation impairment in patients with Parkinson's disease. In a behavioral paradigm, patients and matched control participants have to perform a perceptive task on predicted visual action-effects mixed with mispredicted visual action effects. Performances should be better in mispredicted visual action effects for control participants only.

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

intervention_type: Behavioral


title: Effect of Hypoxia on Cognitive Assessment and Cerebral Activity in Healthy Volunteers WP1 P002 PHARMACOG

acronym: Hypoxia

summary: The early assessment of new symptomatic drugs for Alzheimer disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development. In healthy volunteers, to test the reverse effect of symptomatic drugs, it is necessary to induce transient and reversible cognitive impairment and cerebral activity changes by a challenge test. In this context, a transient hypoxia could be relevant.

lead_sponsor: University Hospital, Lille

location_facility:
Centre d'investigation Clinique
Centre d'Investigation Clinique, CHRU


title: Laparoscopic Training With and Without Robotic Assistance for Surgical Internes: a Randomized Study

acronym: LAPRA

summary:
The primary objective of this study is to compare two groups of gynecologic/urologic/visceral internes in terms of the time required to perform a laparoscopic surgical intervention (nephrectomy) on an animal model (pig).

The two groups of internes differ by the type of training they received: (1) Pelvic-Trainer training with robotic assistance versus (2) Pelvic-Trainer training without robotic assistance.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau