title: Scaling-up Packages of Interventions for Cardiovascular Disease Prevention in Selected Sites in Europe and Sub-Saharan Africa: An Implementation Research

summary:
Cardiovascular disease is the leading cause of death in the world. 17.5 million people died in 2012 due to a cerebrovascular disease (31% of all causes of death). In Europe more than 50% of deaths are due to cardiovascular disease. The mortality rate for cardiovascular disease is higher in the lower socio-economic levels. Three-quarters of deaths from cardiovascular disease occur in developing countries. According to estimates in 2030, cardiovascular disease will be responsible for more deaths than the sum of infectious, nutritional, maternal and perinatal diseases in developing countries.

Measures to prevent cardiovascular risk factors have been shown to be effective.

The lack of an adequate primary care network in developing countries limits the screening and treatment of patients with cardiovascular risk factors. As a result, these patients do not benefit from adequate prevention, are diagnosed late and remain disabled or die at a young age, resulting in significant additional costs for families but also at the macroeconomic level.

Interventions are possible on a large scale (policies against tobacco and adverse dietary behavior, promote physical activity, etc.). Actions are possible on an individual level, both in primary prevention (control of cardiovascular risk factors) and secondary prevention, where many treatments have proved their effectiveness. These interventions are effective and cost-effective from a macroeconomic perspective. It was estimated that the cost of such interventions would not exceed 4% of health expenditure in developing countries and 1-2% in rich countries.

The World Health Organization insists on the importance of the triad composed by the patient and his family, community and health professionals. Results are possible only when these three components work together for the same purpose. Numerous studies show the benefit of the involvement of patients in their care in the rich countries and in the developing countries.

lead_sponsor: University Hospital, Brest

location_facility:
Plouray
Laniscat
Guémené-sur-Scorff
Saint Nicolas du Pelem
Le Faouet
Spezet
Chateauneuf du Faou
Plonévez du Faou
Poullaouen
Tregourez
Landeleau
LAZ
Roudouallec
Nevez
Plounevez-Quintin
Guiscriff
Plonevez du faou
La Chapelle Thouarault
Rostrenen
Coray
Carhaix Plouguer


title: Double-blinded Multicenter Randomized Controlled Trial Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia

acronym: AMIKINHAL

summary:
The objective of the study is to prove that after the third day of invasive mechanical ventilation a three-day course of inhaled amikacin reduces the incidence of subsequent VAP.

Parallel two group double blind randomized controlled clinical trial. Individual randomization, performed on day 4 of invasive mechanical ventilation, will be stratified on centre in order to account for variations in VAP prevention bundle implementation and use of systemic antibiotics the day of randomization. Patients will be treated three consecutive days with inhaled amikacin or placebo. Patients will be followed up daily in the intensive care unit for the occurrence of VAP according to international guidelines until day 28.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Tavernier E, Barbier F, Meziani F, Quenot JP, Herbrecht JE, Landais M, Roux D, Seguin P, Schnell D, Veinstein A, Veber B, Lasocki S, Lu Q, Beduneau G, Ferrandiere M, Dahyot-Fizelier C, Plantefeve G, Nay MA, Merdji H, Andreu P, Vecellio L, Muller G, Cabrera M, Le Pennec D, Respaud R, Lanotte P, Gregoire N, Leclerc M, Helms J, Boulain T, Lacherade JC, Ehrmann S; REVA network and the CRICS-TRIGGESEP F-CRIN network. Inhaled amikacin versus placebo to prevent ventilator-associated pneumonia: the AMIKINHAL double-blind multicentre randomised controlled trial protocol. BMJ Open. 2021 Sep 14;11(9):e048591. doi: 10.1136/bmjopen-2020-048591.

family: Tavernier

full_name: Elsa Tavernier

given: Elsa

sequence: first

family: Barbier

full_name: Francois Barbier

given: Francois

sequence: additional

family: Meziani

full_name: Ferhat Meziani

given: Ferhat

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Herbrecht

full_name: Jean-Etienne Herbrecht

given: Jean-Etienne

family: Landais

full_name: Mickael Landais

given: Mickael

family: Roux

full_name: Damien Roux

given: Damien

family: Seguin

full_name: Philippe Seguin

given: Philippe

family: Schnell

full_name: David Schnell

given: David

family: Veinstein

full_name: Anne Veinstein

given: Anne

family: Veber

full_name: Benoît Veber

given: Benoît

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

family: Lu

full_name: Qin Lu

given: Qin

family: Beduneau

full_name: Gaetan Beduneau

given: Gaetan

family: Ferrandiere

full_name: Martine Ferrandiere

given: Martine

family: Dahyot-Fizelier

full_name: Claire Dahyot-Fizelier

given: Claire

family: Plantefeve

full_name: Gaetan Plantefeve

family: Nay

full_name: Mai-Anh Nay

given: Mai-Anh

family: Merdji

full_name: Hamid Merdji

given: Hamid

family: Andreu

full_name: Pascal Andreu

given: Pascal

family: Vecellio

full_name: Laurent Vecellio

given: Laurent

family: Muller

full_name: Grégoire Muller

given: Grégoire

family: Cabrera

full_name: Maria Cabrera

given: Maria

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

location_facility: Service de Réanimation Médicale - Hôpital Charles Nicolle

location_facility: Service de Réanimation Médicale - CHU La Milétrie

location_facility: Service de Réanimation Médicale - CHU Rouen

location_facility: Service de Réanimation Médicale - Hôpital de Hautepierre

location_facility: Service de Réanimation Médicale - Hôpital Pitié Salpêtrière

location_facility: Service de Réanimation Médicale - CHD Les Oudairies

location_facility: Service de Réanimation Médicale - CH de Montauban

location_facility: Service de Réanimation Médicale - Hôpital La Croix-Rousse

location_facility: Service de Réanimation Médicale - CH d'Angoulême

location_facility: Service de Réanimation Médicale - CHU Pontchaillou

location_facility: Service de Réanimation médicale, Hôpital Trousseau

location_facility: Service de Réanimation Médicale - Hôpital Louis Mourier


title: Motivations and Psychological Aspects of the Gametes' Donation

acronym: DonDon

summary: The main objective is to study donors' personality and motivations characteristics of the different recruitment methods and thus to answer questions related to the donation's approach, its representations as well as motivations and the profile of the donors.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Ahuja KK, Mostyn BJ, Simons EG. Egg sharing and egg donation: attitudes of British egg donors and recipients. Hum Reprod. 1997 Dec;12(12):2845-52.

ReferenceCitation: Cauvin P. [Motivations of oocytes donors]. Gynecol Obstet Fertil. 2009 Nov-Dec;37(11-12):934-41. doi: 10.1016/j.gyobfe.2009.09.003. Epub 2009 Oct 12. French.

ReferenceCitation: Pennings G. Mirror gametes donation. J Psychosom Obstet Gynaecol. 2007 Dec;28(4):187-91. Review.

ReferenceCitation: Sydsjö G, Lampic C, Brändström S, Gudmundsson J, Karlström PO, Solensten NG, Thurin-Kjellberg A, Svanberg AS. Personality characteristics in a Swedish national sample of identifiable oocyte donors. BJOG. 2011 Aug;118(9):1067-72. doi: 10.1111/j.1471-0528.2011.02953.x. Epub 2011 Apr 11.

ReferenceCitation: Sydsjö G, Lampic C, Brändström S, Gudmundsson J, Karlström PO, Solensten NG, Thurin-Kjellberg A, Skoog Svanberg A. Who becomes a sperm donor: personality characteristics in a national sample of identifiable donors. BJOG. 2012 Jan;119(1):33-9. doi: 10.1111/j.1471-0528.2011.03172.x. Epub 2011 Oct 18.

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse

location_facility: CECOS Provence-Alpes-Côte d'Azur Marseille

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Multicentric Prospective Cohort Study in Patients With Irreversible Biventricular Heart Failure to Assess the Efficacy and Safety of Carmat TAH, Its Clinical Utility and Cost, as a Bridge to Transplantation

acronym: EFICAS

summary: The objective of this clinical investigation is to evaluate the efficacy and the safety of the Carmat Total Artificial Heart for the treatment of refractory advanced heart failure in transplant eligible patients.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Treatment

lead_sponsor: Carmat SA

location_facility: Centre Hospitalier Régional Universitaire

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients

summary: Following the acute phase of COVID, some patients may have sequelae, such as breathing difficulties or malnutrition. We hypothesize that a functional and respiratory rehabilitation program associated with personalized nutritional care will improve quality of life, physical performance and respiratory capacities and will decrease the prevalence of malnutrition among those patients.

primary_purpose: Supportive Care

lead_sponsor: Rennes University Hospital

location_facility:
Centre Hospitalier de Saint-Brieuc
Hôtel Dieu Paris
Centre Hospitalier Bretagne Atlantique
Centre Hospitalier de Cornouaille
CHU Rennes


title: ONCOVID-AURA: Excess Risk of Morbi-mortality Due to COVID-19 in Patients With Cancer

acronym: ONCOVID-AURA

summary:
Context:

Based on currently available data, most of national health authorities and consensus expert groups have written guidelines for the management of cancer patients in the context of COVID. However, the preparation of these guidelines was limited by the scarcity of solid epidemiological data. For example, the experts were uncomfortable to formulate precise guidelines on which anti-cancer treatment should be interrupted or replaced, on which patients, and how to adapt supportive drug prescriptions.

Objectives :

To measure the excess risk of mortality and morbidity of patients with a history of cancer among patients hospitalized for a SARS-CoV-2 infection.
To identify factors associated with the risk of death and morbidity among patients with cancer.

Methodology:

Retrospective inclusion of n=200 cancer patients hospitalized for COVID and n=400 matched (based on age, gender, and comorbidity) non-cancer patients hospitalized for COVID. Two analyses will be performed (after the inclusion of n=100 and n=200 patients with cancer). A logistic modeling of the odds ratio of death associated to the exposition factor (i.e. cancer) and adjusted for the matching parameters (age, gender, comorbidities) will be proposed.

We will then look for the factors (related to the patients, the cancer or the treatment) that modify the odds radio.

Expected results:

The data generated will help the medical and scientific community to evaluate the increasing risk of cancer patients infected by SARS-CoV-2 compared to the non-cancer population, to identify patients at higher risk of severe infection, but also the anticancer treatments associated with an increased risk of severe infections.

Impact:

These data will contribute to guide the future recommendations concerning cancer patient's care in the context of the COVID-19 pandemic. There is a real risk that the SARS-CoV epidemic, or other respiratory viruses epidemic, will become recurrent in the future. Thus, it is of crucial importance for now and for the future to know which are the major factors associated with severe infections

time_perspective: Retrospective

ipd_sharing: Undecided

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre Hospitalier Uniersitaire de Clermont-Ferrand

location_facility: Centre de lutte contre le Cancer JEAN PERRIN

location_facility: Institut de Cancérologie de la Loire Lucien Neurwirth

location_facility: Centre Hospitalier Universitaire de St Etienne


title: Chilblains, COVID-19 and Lockdown: Epidemiologic Study

acronym: ECCES

summary:
Chilblains (inflammatory lesion of the feet or hands) have been reported with an unusual frequency during the confinement period, most commonly in children, teenagers and young adults. The aim of the ECCES study is to find out whether these manifestations of chilblains can be linked to the SARS-CoV-2 coronavirus.

For this, an epidemiologic study will compare two types of family (or more precisely people who were confined together in March-April-May):

"case family" in which at least one of the members had chilblains
"comparator family" in which none of the members had chilblains Environment (home lockdown) of the two types of family will be analyzed. Each member of the "family" will be suggested doing a serological test.

design_allocation: Non-Randomized

primary_purpose: Other

location_facility:
CHU Angers
CHRU Brest
CHU Nantes
CHU Rennes
CHRU Tours

intervention_type: Diagnostic Test


title: A Randomized Non-comparative Phase II Study of Anti-PDL1 ATEZOLIZUMAB (MPDL3280A) or Chemotherapy as Second-line Therapy in Patients With Small Cell Lung Cancer (SCLC)

summary: Chemotherapy still constitutes the backbone of small-cell lung cancer (SCLC) therapy, particularly in the extensive disease (ED) stage (ED-SCLC). Despite the fact that a substantial complete response rate could be achieved in SCLC patients receiving etoposide - cisplatin doublet, cure remains the exception. Overall survival in patients receiving this combination is 10 months and progression free survival 6.3 months. At time of progression two options are hitherto accepted: reinduction of carboplatin - etoposide doublet or, for patients unfit for reinduction, topotecan single-drug regimen. However, in both clinical cases, median survival hardly achieves 33 weeks. Consistent data using anti - PDL1 (Programmed death-ligand 1) or anti PD1 (programmed cell death 1) antibodies suggest that they are active as single drug regimens in many malignant diseases. Taking into account the rich tumor infiltrating lymphocyte in pathological specimens of SCLC, we can hypothesize that experimental use of ATEZOLIZUMAB (MPDL3280A) in patients is ethical pending that it demonstrates activity in the second line setting.

ReferenceCitation: Negre E, Coffy A, Langlais A, Daures JP, Lavole A, Quoix E, Molinier O, Greillier L, Audigier-Valette C, Moro-Sibilot D, Westeel V, Morin F, Roch B, Pujol JL. Development and Validation of a Simplified Prognostic Score in SCLC. JTO Clin Res Rep. 2020 Feb 12;1(1):100016. doi: 10.1016/j.jtocrr.2020.100016. eCollection 2020 Mar.

family: Negre

full_name: Elodie Negre

given: Elodie

family: Coffy

full_name: Amandine Coffy

given: Amandine

family: Langlais

full_name: Alexandra Langlais

given: Alexandra

family: Daures

full_name: Jean-Pierre Daures

given: Jean-Pierre

family: Lavole

full_name: Armelle Lavole

given: Armelle

family: Quoix

full_name: Elisabeth Quoix

given: Elisabeth

family: Molinier

full_name: Olivier Molinier

given: Olivier

family: Greillier

full_name: Laurent Greillier

family: Audigier-Valette

full_name: Clarisse Audigier-Valette

given: Clarisse

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Westeel

full_name: Virginie Westeel

given: Virginie

family: Morin

full_name: Franck Morin

given: Franck

family: Roch

full_name: Benoît Roch

family: Pujol

full_name: Jean-Louis Pujol

given: Jean-Louis

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JTO Clinical and Research Reports

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
Annemasse - CH
Centre Hospitalier - Pneumologie
Angers - CHU
Centre Antoine Lacassagne
CH
Lorient - CHBS
CHG de Pau
CHU Tours - Pneumologie
GH Paris Saint-Joseph
Centre Hospitalier
APHP - Paris Bichat
Rouen - CHU
Montpellier - CHRU
Toulouse - CHU Larrey
CHRU Grenoble
AP-HP Hopital Tenon - Pneumologie
Mulhouse - CH
HCL - Lyon Sud (Pneumologie)

intervention_type: Drug


title: Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women.

acronym: VIGI-MESH

summary: Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women Implantable medical devices (meshes) used in pelvic organ prolapse surgery (genital prolapse, rectal prolapse), or incontinence surgery may be source of severe complications.

lead_sponsor: Poitiers University Hospital

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

intervention_type: Procedure


title: Prospective Evaluation of Oral Alkalinization by Urologists and Nephrologists: Evolution of the Extracellular Compartment

acronym: AlcalUN

summary: Metabolic acidosis recovers a wide range of diseases in which an oral alkalinization could be useful. This therapeutic intervention has been said to increase extracellular volume leading to rising blood pressure. No prospective data has been published in clinical routine. Here, investigators propose to follow patients in which an oral alkalinization is indicated: blood pressure, body weight, and a clinical evaluation of the extracellular compartment will be performed at the beginning and during the follow-up of participants. The principal criterion of evaluation will be the variation in the extracellular compartment.

lead_sponsor: Jean-Philippe Bertocchio

location_facility: La Conception University Hospital, AP-HM

location_facility: Centre Hospitalier Pierre Oudot - Bourgoin-Jallieu

location_facility: E.C.H.O. (Expansion des Centres d'Hémodialyse de l'Ouest)

location_facility: Institut Phocéen de Néphrologie, Clinique Bouchard


title: A Multi-centre, Multinational, Prospective Observational Registry to Collect Safety and Outcome Data in Patients Diagnosed With Severe Hepatic Veno-occlusive Disease (VOD) Following Hematopoietic Stem Cell Transplantation (HSCT) and Treated With Defitelio®

summary:
Following the licencing of a new drug, Defitelio®, indicated for the treatment of severe Veno-Occlusive Disease of the liver (sVOD), a rare but serious complication of haematopoietic stem cell transplantation (HSCT), as a specific obligation (SOB), the manufacture and marketing Authorisation Holder (MHA) (Gentium, a Jazz Pharmaceuticals Company) was required by PRAC (Pharmacovigilance Risk Assessment Committee) to set up a disease registry to collect safety and outcome data, and to assess patterns of utilization of Defitelio® in the post-approval setting. This registry is a Post Authorization Safety Study (PASS), is being coordinated in collaboration with the European Society for Blood and Marrow Transplantation (EBMT). For this study, anonymised clinical data are being collected from patients who develop VOD and and treated with and patients who have been treated with Defitelio® for conditions other than sVOD.

The study DOES NOT involve decisions about treatment, which are clinical decisions, but merely collection of data for patients who develop this complication, whether or not they receive treatment and for patients who are treated with Defitelio® for any other reasons.The study DOES NOT involve decisions about treatment, which are clinical decisions, but merely collection of data for patients who develop this complication, whether or not they receive treatment and for patients who are treated with Defitelio® for any other reasons.

ReferenceCitation: Mohty M, Battista ML, Blaise D, Calore E, Cesaro S, Maximova N, Perruccio K, Renard C, Wynn R, Zecca M, Labopin M, Hanvesakul R, Amber V, Ryan RJ, Lawson S, Ciceri F. A multicentre, multinational, prospective, observational registry study of defibrotide in patients diagnosed with veno-occlusive disease/sinusoidal obstruction syndrome after haematopoietic cell transplantation: an EBMT study. Bone Marrow Transplant. 2021 Oct;56(10):2454-2463. doi: 10.1038/s41409-021-01265-2. Epub 2021 May 31.

family: Mohty

full_name: Mohamad Mohty

given: Mohamad

family: Battista

full_name: Marta Lisa Battista

given: Marta Lisa

family: Blaise

full_name: Didier Blaise

given: Didier

family: Calore

full_name: Elisabetta Calore

given: Elisabetta

family: Cesaro

full_name: Simone Cesaro

given: Simone

family: Maximova

full_name: Natalia Maximova

given: Natalia

family: Perruccio

full_name: Katia Perruccio

given: Katia

family: Renard

full_name: Cecile Renard

given: Cecile

family: Wynn

full_name: Robert Wynn

given: Robert

family: Zecca

full_name: Marco Zecca

given: Marco

family: Labopin

full_name: Myriam Labopin

given: Myriam

family: Hanvesakul

full_name: Raj Hanvesakul

given: Raj

family: Amber

full_name: Vian Amber

given: Vian

family: Ryan

full_name: Robert J. Ryan

given: Robert J.

family: Lawson

full_name: Sarah Lawson

given: Sarah

family: Ciceri

full_name: Fabio Ciceri

given: Fabio

journal_name: Bone Marrow Transplantation

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Jazz Pharmaceuticals

location_country:
Italy
United Kingdom
France
Portugal

location_facility: UO Oncoematologia Ospedale Pediatrico Mayer

location_facility: Ospedale Ca' Granda Ospedale Maggiore di Milano

location_facility: Great Ormond Street Hospital Children's Charity

location_facility: Clinica Ematologica-Azienda Ospedaliero Universitaria

location_facility: Policlinico G.B. Rossi, Clinica di Oncoematologia Pediatrica

location_facility: Istituto per l'Infanzia IRCCS Burlo Garofolo

location_facility: CHU Bordeaux Groupe hospitalier Pellegrin Enfants


type: Registry Identifier

title: Étude Post-marché, Prospective, Multicentrique, Ouverte, d'évaluation de la prothèse Totale d'épaule inversée Medacta Shoulder System.

acronym: MSS

summary:
The goal of this study is to evaluate the performance of the Medacta Shoulder System total reverse shoulder prosthesis, at 2 years of follow up, in patients who required this prosthesis for primary omarthrosis, cuff tear arthropathy, massive cuff tear or post instability arthropathy.

The main goal is to evaluate at 2 years post-operatively the shoulder function of patients. The secondary goals are to assess the rate of complications, the survival rate of Reverse Medacta Shoulder System, the positioning of the prosthesis,pthe behaviour of the bone in contact with the humeral stem, Patient satisfaction and evolution of shoulder function in patients at 3 months and 1 year post-surgery.

lead_sponsor: University Hospital, Tours

location_facility:
Chu Rennes
Chu Angers
Chu Tours
Polyclinique santé atlantique
Clinique Mutualiste la Sagesse


title: Interest of PET-PSMA Imaging Potentiated by Androgen Blockade in Patients With Biological Relapse or Persistent Biological Disease of a Localized Prostatic Adenocarcinoma After Initial Treatment

acronym: PREFAcE

summary: Evaluation of the interest of PET-PSMA imaging potentiated by androgen blockade in patients with biological relapse or persistent biological disease of a localized prostatic adenocarcinoma after initial treatment

lead_sponsor: Centre Leon Berard

location_facility: Centre Hospitalier de Grenoble Hôpital Nord Michallon


title: An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy on Chronic Pruritus in Adults With Plaque Psoriasis

acronym: PAP

summary: To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis

lead_sponsor: Pierre Fabre Dermo Cosmetique

location_country: France Spain

location_facility: CH de Boulogne sur Mer Hôpital DUCHENE - service de dermatologie

location_facility: Centre Hospitalier de Dunkerque - Service de Dermatologie

location_facility: GHRMSA Hôpital Emile Muller Service de Dermatologie

location_facility: Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2

location_facility: CHU de Poitiers Pole régional de cancérologie Service de dermatologie

location_facility: Hospital de la Santa Creu i Sant Pau Dept. of Dermatology

location_facility: CHU Nantes - Unité Dermato-Cancérologie 7° nord Hotel Dieu

location_facility: CHU Nice - Hôpital l'Archet 1 - Centre de recherche clinique


type: Other Identifier

title: Detection of Intracorporeal Bioresistant Nanocomposites Tracing Short- and Long-term Neurological Disorders in a Collective Fulguration

acronym: Fulgurnano

summary:
Objective: To demonstrate the presence of bioresistant intracorporeal carbon-based nanocomposites in subjects exposed to a fulguration, in the immediate aftermath of this fulguration and 24 months (+/- 6 months) after the accident, on blood and urine samples, then in comparison with blood and urine samples from 14 healthy subjects.

Hypothesis: Lightning discharge in the human body reveals the presence of multi-functional nanoparticles which are reassembled under the impact of the electric discharge into nanostructured films, filaments and aggregates; they consist of dispersed graphene-like nanoparticles embedded in an aliphatic cross-reticulated matrix. The high electrical conductivity of the nanoinclusions, their refractory properties and the cross-reticulation of the nanoassemblages explain their biorésistance.

The graphene-like multi-functional nanoparticles are assumed to trace a population of aerosols formed in the atmosphere by plasma discharge which is present in air, water and all natural resources. Their ability to undergo changes from folded nanosheets to confined ultra-fine nanoparticles allow them to be inhaled or absorbed by the human body, or to be ingested with food.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CH de SAINT-DIE-DES-VOSGES
CH Henri Mondor
CHRU Bradois
CH de Luneville
CHRU de Nancy


title: Become of Patients Infected or Suspected of Being Infected by Covid-19 and Supported by the GHPSJ and the Establishments of the Paris Plaisance Hospital City

acronym: COVIDGHPSJCite

summary:
The ongoing Coronavirus (Covid-19) pandemic is causing a major global health crisis and is shaking up hospital organizations. To date, the recognized risk factors for severe forms of Covid-19 infection are elderly patients (> 70 years), obese patients, patients with chronic renal or respiratory pathologies, cardiovascular history (stroke or coronary artery disease), chronic respiratory conditions, high blood pressure, diabetes, and cancer. Covid-19 is manifested by a risk of acute respiratory distress syndrome requiring management by invasive ventilation. The lethality of this infection is around 4% in the current data.

Drastic precautionary measures for the transmission of the virus, as well as the provision of critical care beds by canceling any scheduled non-urgent intervention or consultation, have shaken up the hospital organization.

In this context, it is essential to have forward-looking data in real time to adjust the care offer and better understand the impact of Covid-19 on the patient populations treated.

time_perspective: Other

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility:
Fondation Sainte-Marie
AURA Paris Plaisance
Groupe Hospitalier Paris Saint-Joseph
Hôpital Bellan
Hôpital Marie Lannelongue


lead_sponsor: UNICANCER

location_country: Sweden France Spain

acronym: ULTIMATE

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Institut Daniel Hollard Groupe Hôspitalier

type: EudraCT Number

source: euctr

title: A Phase II Trial Testing Durvalumab Combined With Endocrine Therapy in Patients With ER+/Her2- Breast Cancer Eligible for Neoadjuvant Endocrine Therapy And Who Present CD8+ T Cell Infiltration After 4-6 Weeks Exposure to Immune-Attractant

summary: This is an open-label, multicentric, international, phase II trial testing aromatase inhibitors in combination with durvalumab in patients with CD8+ T cell infiltration (>10% CD8+ T cells in the tumor). The trial includes two sequences: The first part of the treatment will consist in 4-6 weeks treatment with immune-attractants; in the second part, CD8+ patients will receive 6 months of durvalumab combined with exemestane.


title: Multidimensional Assessment of Dyspnea in Asthma

acronym: MIDAS

summary:
Breathlessness is a symptom of asthma that occurs in relation with lower airway obstruction. However, this sensation is not specific of asthma and may be the expression of other disorders. In particular, it can testify to anxiety or hyperventilation, two disorders frequently associated with asthma. The systematic interpretation of dyspnea as a manifestation of asthma in asthmatic patients may lead to an inappropriate increase in asthma controllers.

Identifying the cause of dyspnea in asthmatic patients (airway obstruction, anxiety or hyperventilation) is therefore crucial for the clinician.

This could be facilitated by a multidimensional assessment of dyspnea, evaluating the kind of sensation felt by the patient (for example chest tightness, air hunger etc.) and emotions associated to respiratory sensations (for example anxiety, fear etc.).

The objectives of this project are to assess: (1) the sensory and affective dimensions of dyspnea in asthma and, (2) their connection to asthma control, anxiety and depression.

lead_sponsor: University Hospital, Lille

location_facility: Hopital Saint Vincent - Saint Antoine - Lille

location_facility: Hu Paris Sud Site Kremlin Bicetre Aphp - Le Kremlin Bicetre

location_facility: Hu Paris Nord Site Bichat Aphp - Paris 18


status: Terminated

lead_sponsor: Actelion

acronym: OPTIMA

location_facility:
Hôpital Nord
Hôpital Albert Michallon
Hôpital Bicètre
Hôpital Côte de Nacre
Hôpital Dupuytren
Hôpital Louis Pradel
Hôpital Pontchaillou
CHR La Miletrie
Hôpital Charles Nicolle
Hôpital Arnaud de Villeneuve
Hôpital Bretonneau
Hôpital Civil
Hôpital Jean Minjoz
Hôpital Robert Debré
Hôpital de Haut Levêque
Hôpital Larrey
Hôpital Timone Adultes
CHU Site du Bocage

title: Prospective, Multicenter, Open-label Study Evaluating the Effects of First-line Oral Combination Therapy of Macitentan and Tadalafil in Patients With Newly Diagnosed Pulmonary Arterial Hypertension (OPTIMA).

summary: The purpose of the study is to document the effect of first line dual oral combination therapy with macitentan 10mg and tadalafil 40mg on pulmonary vascular resistance (PVR) in treatment-naïve patients with newly diagnosed pulmonary arterial hypertension (PAH).

status_simplified: Unknown


ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

lead_sponsor: Sanofi

acronym: Transition II

location_facility:
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Investigational Site Number 250007
Investigational Site Number 250086
Investigational Site Number 250065

ipd_sharing: Yes

title: An Interventional, Open-label, Single-arm, Multicenter, 24 Weeks Phase 4 Study Assessing the Efficacy and Safety of Toujeo in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin

summary:
Primary Objective:

The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c) improvement.

Secondary Objectives:

Evolution of fasting plasma glucose
Evolution of insulin dose and body weight
Hypoglycemia incidence
Safety
Patients satisfaction when they change their insulin for HOE901-U300


title: Randomized Multicenter, Phase III Trial Evaluating the Safety of 2 Schedules of Cabazitaxel (Bi-weekly Versus Tri-weekly) Plus Prednisone in Elderly Men (≥ 65years) With mCRPC Previously Treated With a Docetaxel-containing Regimen

acronym: CABASTY

summary: The purpose of this study is to evaluate the incidence of grade ≥ 3 neutropenia and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 65 years) with mCRPC previously treated with a docetaxel-containing regimen.

ReferenceCitation: Pobel C, Auclin E, Procureur A, Clément-Zhao A, Simonaggio A, Delanoy N, Vano YA, Thibault C, Oudard S. Cabazitaxel schedules in metastatic castration-resistant prostate cancer: a review. Future Oncol. 2021 Jan;17(1):91-102. doi: 10.2217/fon-2020-0672. Epub 2020 Dec 2. Review.

name: Department of Medical Oncology, European Hospital Georges Pompidou & University of Paris, 20 rue Leblanc, Paris, 75015, France

family: Pobel

full_name: Cedric Pobel

given: Cedric

family: Auclin

full_name: Edouard Auclin

given: Edouard

family: Procureur

full_name: Adrien Procureur

given: Adrien

family: Clément-Zhao

full_name: Alice Clément-Zhao

given: Alice

family: Simonaggio

full_name: Audrey Simonaggio

given: Audrey

family: Delanoy

full_name: Nicolas Delanoy

given: Nicolas

family: Vano

full_name: Yann-Alexandre Vano

given: Yann-Alexandre

family: Thibault

full_name: Constance Thibault

given: Constance

family: Oudard

full_name: Stéphane Oudard

given: Stéphane

journal_name: Future Oncology

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_country: Germany France Netherlands

location_facility: Urologie und Kinderurologie Marienkrankenhaus Bergisch

location_facility: Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie,

location_facility: Universitäts-klinik für Urologie und Kinderurologie


title: Evaluation of the Patient Skin Dose in Interventional Radiology

acronym: DPPRI

summary:
Studies on radiation induced patients' skin lesions in interventional radiology highlighted the need for optimized and personalized patient dosimetry and adapted patient follow-up. Measurements using Gafchromic® films or thermoluminescent dosimeters have long been the only way to accurately evaluate the maximum absorbed dose to the patient skin. However as these dose measurements are tedious and expensive, they could not be systematically applicable in clinical practice. Therefore, more practical calculation methods have been developed. These software programs calculate the skin dose using dosimetric information from images DICOM header or radiation dose structured reports (RDSRs). Validation studies of these software programs are rare and when existent have many limitations.

Radiation Dose Monitor (RDM from Medsquare) is a software program for archiving and monitoring of radiation dose (DACS, Dosimetry Archiving Communication System) used in routine in the investigator's hospitals. A new functionality developed in RDM allows quick estimation without in-vivo measurements of the absorbed dose to the skin of the patient. Comparing RDM calculations with in-vivo measurements will enable this software validation so that it can be used in clinical routine.

Main objective: to validate RDM software for calculating patient skin dose in interventional radiology.

time_perspective: Cross-Sectional

ReferenceCitation: Food and Drug Administration (FDA). Avoidance of serious x-ray-induced skin injuries to patients during fluoroscopically-guided procedures, 1994.

ReferenceCitation: Valentin J. Avoidance of radiation injuries from medical interventional procedures. Ann ICRP. 2000;30(2):7-67. Review.

ReferenceCitation: Miller DL. Efforts to optimize radiation protection in interventional fluoroscopy. Health Phys. 2013 Nov;105(5):435-44. doi: 10.1097/HP.0b013e31829c355a. Review.

ReferenceCitation: Bor D, Olğar T, Toklu T, Cağlan A, Onal E, Padovani R. Patient doses and dosimetric evaluations in interventional cardiology. Phys Med. 2009 Mar;25(1):31-42. doi: 10.1016/j.ejmp.2008.03.002. Epub 2008 Apr 25.

ReferenceCitation: Ying CK, Kandaiya S. Patient skin dose measurements during coronary interventional procedures using Gafchromic film. J Radiol Prot. 2010 Sep;30(3):585-96. doi: 10.1088/0952-4746/30/3/012. Epub 2010 Sep 8.

ReferenceCitation: Giordano C, D'Ercole L, Gobbi R, Bocchiola M, Passerini F. Coronary angiography and percutaneous transluminal coronary angioplasty procedures: Evaluation of patients' maximum skin dose using Gafchromic films and a comparison of local levels with reference levels proposed in the literature. Phys Med. 2010 Oct;26(4):224-32. doi: 10.1016/j.ejmp.2010.01.001. Epub 2010 Feb 8.

ReferenceCitation: den Boer A, de Feijter PJ, Serruys PW, Roelandt JR. Real-time quantification and display of skin radiation during coronary angiography and intervention. Circulation. 2001 Oct 9;104(15):1779-84.

ReferenceCitation: Balter S. Methods for measuring fluoroscopic skin dose. Pediatr Radiol. 2006 Sep;36 Suppl 2:136-40. Review.

ReferenceCitation: Chida K, Kagaya Y, Saito H, Takai Y, Takahashi S, Yamada S, Kohzuki M, Zuguchi M. Total entrance skin dose: an effective indicator of maximum radiation dose to the skin during percutaneous coronary intervention. AJR Am J Roentgenol. 2007 Oct;189(4):W224-7.

ReferenceCitation: Khodadadegan Y, Zhang M, Pavlicek W, Paden RG, Chong B, Schueler BA, Fetterly KA, Langer SG, Wu T. Automatic monitoring of localized skin dose with fluoroscopic and interventional procedures. J Digit Imaging. 2011 Aug;24(4):626-39. doi: 10.1007/s10278-010-9320-7.

ReferenceCitation: Sanchez RM, Vano E, Fernandez JM, Escaned J. Evaluation of a real-time display for skin dose map in cardiac catheterisation procedures. Radiat Prot Dosimetry. 2015 Jul;165(1-4):240-3. doi: 10.1093/rpd/ncv033. Epub 2015 Mar 18.

ReferenceCitation: Digital Imaging and Communications in Medicine (DICOM). Supplement 94: Diagnostic X-Ray radiation Dose Reporting (Dose SR), 2005.

ReferenceCitation: 1IEC/PAS 61910-1. Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured report for radiography and radioscopy, 2007.

ReferenceCitation: IEC/PAS 61910-1. Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured report for radiography and radioscopy, 2014.

ReferenceCitation: Johnson PB, Borrego D, Balter S, Johnson K, Siragusa D, Bolch WE. Skin dose mapping for fluoroscopically guided interventions. Med Phys. 2011 Oct;38(10):5490-9. doi: 10.1118/1.3633935.

ReferenceCitation: Khodadadegan Y, Zhang M, Pavlicek W, Paden RG, Chong B, Huettl EA, Schueler BA, Fetterly KA, Langer SG, Wu T. Validation and initial clinical use of automatic peak skin dose localization with fluoroscopic and interventional procedures. Radiology. 2013 Jan;266(1):246-55. doi: 10.1148/radiol.12112295. Epub 2012 Nov 9.

ReferenceCitation: Bordier C, Klausz R, Desponds L. Patient dose map indications on interventional X-ray systems and validation with Gafchromic XR-RV3 film. Radiat Prot Dosimetry. 2015 Feb;163(3):306-18. doi: 10.1093/rpd/ncu181. Epub 2014 Jun 17.

ReferenceCitation: Bednarek DR, Barbarits J, Rana VK, Nagaraja SP, Josan MS, Rudin S. Verification of the performance accuracy of a real-time skin-dose tracking system for interventional fluoroscopic procedures. Proc SPIE Int Soc Opt Eng. 2011 Feb 13;7961(796127). pii: 796127_1.

ReferenceCitation: Rana VK, Rudin S, Bednarek DR. A tracking system to calculate patient skin dose in real-time during neurointerventional procedures using a biplane x-ray imaging system. Med Phys. 2016 Sep;43(9):5131. doi: 10.1118/1.4960368.

ReferenceCitation: Greffier J, Van Ngoc Ty C, Bonniaud G, Moliner G, Ledermann B, Schmutz L, Cornillet L, Cayla G, Beregi JP, Pereira F. Assessment of peak skin dose in interventional cardiology: A comparison between Gafchromic film and dosimetric software em.dose. Phys Med. 2017 Jun;38:16-22. doi: 10.1016/j.ejmp.2017.05.044. Epub 2017 May 8.

ReferenceCitation: Magnier F, Poulin M, Van Ngoc Ty C, Osmond E, Bonniaud G, Coulot J, Pereira B, Boyer L, Guersen J, Cassagnes L. Comparison of Patient Skin Dose Evaluated Using Radiochromic Film and Dose Calculation Software. Cardiovasc Intervent Radiol. 2018 May;41(5):762-771. doi: 10.1007/s00270-018-1888-1. Epub 2018 Feb 7.

ReferenceCitation: Jones AK, Pasciak AS. Calculating the peak skin dose resulting from fluoroscopically guided interventions. Part I: Methods. J Appl Clin Med Phys. 2011 Nov 15;12(4):3670. doi: 10.1120/jacmp.v12i4.3670. Review. Erratum in: J Appl Clin Med Phys. 2014 Jul;15(4):402.

ReferenceCitation: Benmakhlouf H, Bouchard H, Fransson A, Andreo P. Backscatter factors and mass energy-absorption coefficient ratios for diagnostic radiology dosimetry. Phys Med Biol. 2011 Nov 21;56(22):7179-204. doi: 10.1088/0031-9155/56/22/012. Epub 2011 Oct 25.

ReferenceCitation: International Commission on radiological Protection. Adult Reference Computational Phantoms. ICRP Publication 110, Ann. ICRP 39(2), 2009.

ReferenceCitation: IEC 61267. Medical Diagnostic X-ray Equipment - Radiation Conditions for Use in the Determination of Characteristics, 2005.

ReferenceCitation: Greffier J, Van Ngoc Ty C, Agelou M, Coulot J, Ledermann B, Ovtchinnikoff S, Pereira F, Beregi JP, Bonniaud G. Impact of the calibration conditions of XR-RV3 films on peak skin dose measurements in interventional radiology. Radiat Prot Dosimetry. 2017 Apr 25;174(2):207-215. doi: 10.1093/rpd/ncw116.

ReferenceCitation: McCabe BP, Speidel MA, Pike TL, Van Lysel MS. Calibration of GafChromic XR-RV3 radiochromic film for skin dose measurement using standardized x-ray spectra and a commercial flatbed scanner. Med Phys. 2011 Apr;38(4):1919-30.

ReferenceCitation: Farah J, Trianni A, Ciraj-Bjelac O, Clairand I, De Angelis C, Delle Canne S, Hadid L, Huet C, Jarvinen H, Negri A, Novák L, Pinto M, Siiskonen T, Waryn MJ, Knežević Ž. Characterization of XR-RV3 GafChromic(®) films in standard laboratory and in clinical conditions and means to evaluate uncertainties and reduce errors. Med Phys. 2015 Jul;42(7):4211-26. doi: 10.1118/1.4922132.

ReferenceCitation: Miyake Et Al H. [Medical electrical equipment - part 2-43: particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures]. Nihon Hoshasen Gijutsu Gakkai Zasshi. 2011;67(3):298-301. Japanese.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: AP-HP, Necker-Enfants Malades Hospital, Pediatric radiology department

location_facility: AP-HP, Lariboisière Hospital, Neuroradiology department

location_facility: AP-HP, Cochin Hospital, Radiology A department

location_facility: AP-HP, Bicêtre Hospital, Nuclear medicine department

location_facility: AP-HP, Lariboisière Hospital, Cardiology department


title: The French Registry on the First-line Treatment of Non High-risk Acute Promyelocytic Leukemia (APL) in Patients Aged ≤ 70 Years

summary: The registry aims to compare the two first-line available treatment approaches in non-high-risk APL patients aged ≤ 70 years - ATRA plus chemotherapy and ATRA plus ATO - in terms of practitioner's choice between the two options, clinical effectiveness and cost-effectiveness, long-term outcome, and short- and long-term toxic effects.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: CHU Hôpital Sud - service Hémato-oncologie Pédiatrique


title: A Multicentre, Open-label, Phase I-II Study Evaluating the Combination of a MEK Inhibitor and a PDL1 Inhibitor in Pediatric and Adult Patients With Locally Advanced and/or Metastatic Soft Tissue Sarcoma.

acronym: COTESARC

summary: The proposed study is a two-step trial with 1) a safety run in part conducted in pediatric patients and 2) a Phase II part in adult and pediatric patients aiming to evaluate the safety and clinical activity of atezolizumab + cobimetinib in advanced/metastatic soft tissue sarcomas.

location_facility:
Centre Léon Bérard
Institut de Cancérologie de l'Ouest
Centre Oscar Lambret
Hôpital de la Timone
Institut Curie


title: OBSERVATOIRE NATIONAL D'UTILISATION D'INFLECTRA™ EN VIE RÉELLE.

acronym: ReFLECT

summary:
National, prospective, multicentre observational study designed for eligible patients treated with Inflectra.

Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the response to treatment.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_facility: Service de rhumatologie - CHU Nantes, Hopital Hotel Dieu

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin

location_facility: Hopital Robert Debre, Service D'Hepato-gastro-enterolo

location_facility: Centre Hospitalier Regional de Besancon, Service de Gastrologie

location_facility: Centre Hospitalier de Lille Hopital Roger Salengro

location_facility: Centre Hospitalier de Cannes Hopital Pierre Nouveau

location_facility: Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre

location_facility: Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre

location_facility: Centre Hospitalier de Montpellier Hopital Saint Eloi

location_facility: Centre Hospitalier Universitaire Gabriel Montpied

location_facility: Centre Hospitalier de Cholet Service d'Hépato-Gastro-Entérologie

location_facility: Centre Hospitalier Carcassonne, Service de Rhumatologie

location_facility: Fondation Maison Sante Bagatelle, Gastro Enterologie

location_facility: Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord

location_facility: Hôpital Edouard HERRIOT- Hospices Civils de Lyon

location_facility: Centre Hospitalier Estaing, Service de Medicine Interne

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Hopital Louis Mourier, Service d'Hepato-Gastroenterologie

location_facility: Hopital Robert Debre, Service d'Hepato-gastro-enterologie et de Cancerologie Digestive


title: Echography in Pregnant Obese Women and Ultrasound Speed.

acronym: EPOWUS

summary: Ultrasound (US) image construction uses equations that contain the value of the propagation velocity of sound waves; this velocity is assumed conventionally to be constant and equal to 1540 m/s in the human body. Since 1977, all manufacturers of US scanners have used this value, which was first established in 1950. In fatty tissue, however, the actual propagation velocity is only in the order of 1450 m/s. US velocity in fat tissue is slower than in other soft tissues (ie:1450 m/s vs 1540 m/s) therefore the intrinsic image quality in terms of sharpness and precision is improved when considering this parameter for image construction The main objective of this study is to evaluate the impact of ultrasound propagation velocity setting on completeness of ultrasound exams and images quality during the second and third trimester fetal ultrasound examination in obese patients.

status: Unknown status

primary_purpose: Diagnostic

ReferenceCitation: Delabaere A, Chauveau B, Lémery D, Ollier A, Guiguet-Auclair C, Mourgues C, Legrand A. Protocol for the e-POWUS Project: multicentre blinded-randomised controlled trial of ultrasound speed choice to improve sonography quality in pregnant women with obesity. BMJ Open. 2021 Sep 21;11(9):e038684. doi: 10.1136/bmjopen-2020-038684.

family: Delabaere

full_name: Amélie Delabaere

given: Amélie

family: Chauveau

full_name: Benoit Chauveau

given: Benoit

family: Lémery

full_name: Didier Lémery

given: Didier

family: Ollier

full_name: Amandine Ollier

given: Amandine

family: Guiguet-Auclair

full_name: Candy Guiguet-Auclair

given: Candy

family: Mourgues

full_name: Charline Mourgues

given: Charline

family: Legrand

full_name: Anne Legrand

given: Anne

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_facility: Hôpital Femme Mére Enfant - Hospices Civils de Lyon

location_facility: Hôpital Cochin - Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Arnaud de Villeneuve - CHU de Montpellier

location_facility: Hôpital Estaing - Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Hôpital de la Croix Rousse - Hospices Civils de Lyon


title: Pilot Study: Interest of Belatacept as a Non-nephrotoxic Immunosuppressive Treatment in Cardiac Transplant Patients at Risk of Chronic Renal Failure

acronym: BELACOEUR

summary:
Heart transplantation (TC) is the standard treatment for terminal heart failure. Chronic kidney disease (CKD) is a common complication responsible for increased mortality and morbidity. The main risk factors for progression to CKD are advanced age, pre-transplantation CKD, degradation of glomerular filtration rate (GFR) in the first year post-transplantation, and nephrotoxicity of calcineurin inhibitors (CNI).

Indeed, these molecules (cyclosporin and tacrolimus), the cornerstone of immunosuppressive treatment, have nephrotoxic effects in the short term (by a hemodynamic effect) and in the long term (by a pro-fibrosin effect).

In renal transplantation (TR), belatacept, a costimulation-inhibiting molecule, used de novo, without CNI, with induction by anti-receptor antibody of Interleukines 2, preserves kidney function. Despite this great advantage, its development is still hampered by a higher number of rejections compared to the CNI group in this originator study. Based on the experience gained in TR, which has since validated its use, the hypothesis is that in heart transplantation, belatacept (Nulojix) combined with minimization of CNI (with induction by antilymphocyte serum), could significantly improve glomerular filtration rate (GFR) in patients at risk of CKD (by removing them from dialysis and possible kidney transplantation) without increasing the risk of rejection.

lead_sponsor: Nantes University Hospital

location_facility:
Bertrand Lelong
Karine Nubret
Claire Garandeau
Laurent Sebbag
Emmanuelle Vermes


title: A Prospective Study to Determine the Cartography of Virologic Reservoir Related to Antiretroviral Concentrations in HIV-1 Chronic Patients Treated by a First Line Treatment Containing Dolutegravir and Associated Nucleoside / Nucleotide Reverse Transcriptase Inhibitors Backbone

acronym: DOLUVOIR

summary: The main objective of the study is to characterize the diffusion of dolutegravir and associated backbone (abacavir/lamivudine or tenofovir/emtricitabine) in HIV-1 chronic patients in the main putative reservoirs, namely inguinal lymph nodes, rectal, fat tissues and sperm.

primary_purpose: Basic Science

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility:
Antoine-Beclere Hospital
Pitie Salpetriere Hospital
Hotel Dieu Hospital
Bicetre Hospital
Necker Hospital


title: Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data

summary: To describe the characteristics of patients treated with Fibryga®, the indications and conditions of use of Fibryga® and, for patients treated " on-demand", the short-term outcomes.

lead_sponsor: Octapharma

location_facility:
Bordeaux Study Site
Valence Study Site
Le Plessis Robinsin Study Site
Nantes Study Site
Marseille Study Site


title: Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease

acronym: COMADHAA

summary: Alcoholic hepatitis carries a risk of high mortality at short term, especially in its severe form. Its diagnosis is confirmed by liver biopsy. The prevalence of alcoholic hepatitis, severe or not severe, is poorly known and prospective data are needed. The present observational study aims to define the prevalence of alcoholic hepatitis among patients admitted for jaundice and determine their outcome according to the severity. Survival and markers of liver dysfunction will be assessed. A biobank including genetic samples will be created to identify the disease profile in terms of inflammation and regeneration. The performance of non-invasive criteria for diagnosis will also be studied.

location_facility:
Hôpital Jean Verdier, AH-HP
Chru Besancon
Chu Montpellier
Centre Hospitalier Universitaire
Hôpital Claude Huriez, CHU


title: Follow-up of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia

acronym: STIM-FU

summary: It's an observational study based on 98 patients included in the STIM trial to extend the monitoring of patients and to have molecular and clinical data, with long follow up. Are there late relapses? What has become patients who relapsed during STIM trial and restarted TKI (inhibitor tyrosine kinase) treatment?

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hôpital Edouard Herriot
Hôpital Necker-Enfants Malades
Hôpital Purpan
Hôpital Saint Louis
CHU d'Angers
Hôpital Claude Huriez
CHU de Nice
Hôpital Morvan
CHU Hôtel-Dieu
CHU de Bordeaux - Haut-Lévêque
Pôle de cancérologie
Centre Hospitalier de Versailles
CHU de Poitiers
Institut Paoli Calmette
Hôpital Civil
CHU Brabois
Hôpital Henri-Mondor
Institut Bergonié
Centre Hospitalier de La Roche Sur Yon

intervention_type: Behavioral


title: Multicenter Prospective Longitudinal Study on the Efficacy of Exclusive Odontological and Medical Treatment in the Management of Chronic Dental Maxillary Sinusitis

acronym: DENTASINUS

summary: The study will be offered to patients for whom chronic maxillary sinusitis will be diagnosed in the first ENT (ear, nose and throat) consultation. These patients will then be seen in a stomatology consultation to determine whether or not a dental cause is objective

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Groupe Hospitalier Intercommunal Le Raincy-Montfermeil

location_facility: Centre Hopitalier Intercommunal Robert Ballanger

location_facility: Centre Hospitalier Intercommunal de Créteil


title: French Validation of a Severity Scale in REM Sleep Behavior Disorder

acronym: SEV-TCSP

summary:
REM (Rapid Eye Movements) Sleep Behavior Disorder (RBD) is a parasomnia characterized by episodes of elaborate or violent motor activity during dreams, which can lead to injury and sleep disruption in patient and / or his/her spouse. This is due to the loss of the normal muscle atonia during REM Sleep. RBD is often associated to neurodegenerative diseases, and may even precede them for several years as an early marker. Currently, there is no scale or tool for assessing the severity of RBD. Nevertheless, it is crucial to have a tool of severity when one wants to study the natural evolution of this disorder, as well as the possible effect of a drug in the context of a clinical trial. A Severity Scale of RBD has recently been proposed within the International RBD Study Group and an international validation study in several languages is being considered.

The main objective of this study is to validate a new scale of severity of the REM sleep behavior disorder (RBD Severity Scale or RBDSS) and to characterize its metrological properties, in particular its concurrent validity, internal consistency and reproducibility

location_facility:
Clinique beausoleil
CHU Clermont-Ferrand
CHU Nantes
AP-HP
Hôpital de la Croix Rousse


title: MObile Technologies In the preVention of POSt-stroke DEPression

acronym: MOTIV-POSDEP

summary: The recent development of acute phase treatments has dramatically improved stroke functional outcome but post-stroke neuropsychiatric disorders, notably post-stroke depression, continue to contribute to the heavy burden of stroke. While these conditions affect about 25% of stroke patients at 3 months, they are under-reported spontaneously by patients and are under-evaluated and treated by clinicians. Other than stroke severity and psychiatric history, risk factors for post-stroke depression remain a matter of debate, thus preventing identification of high-risk patients. Moreover, to date, neither pharmacological nor nonpharmacological treatments have demonstrated a significant benefit in the prevention of this disorder, thereby also impeding the development of early treatment strategies. Yet,the early management of post-stroke depression is critical given its negative influence on long-term functional outcomes, medication adherence, efficient use of rehabilitation services and the risk of stroke recurrence or vascular events. There is a pressing need to develop new tools allowing for the early detection of post-stroke neuropsychiatric complications for each individual patient. The rapid expansion of ambulatory monitoring techniques, such as Ecological Momentary Assessment (EMA), allows daily evaluations of mood symptoms in real time and in the natural contexts of daily life. The investigators have previously validated the feasibility and validity of EMA to assess daily life emotional symptoms after stroke, demonstrating its utility to investigate their evolution during the 3 months following stroke and to identify early predictors of post-stroke depression such as stress reactivity and social support, suggesting that EMA could be used in the early personalized care management of these neuropsychiatric complications. Recently, preliminary data have also emphasized the potential of EMA interventions to improve the outcome of psychiatric disorders.

location_facility: Assistance Publique Hopitaux de Paris - Groupe Hospitalier Paris Saint Joseph


title: Phase II Trial of Weekly Carboplatin-Paclitaxel Adjuvant Chemotherapy After Intensity Modulated Extended-field Chemoradiation in the Treatment of Locally Advanced Cervical Cancer With Para-aortic Positive Nodes

acronym: ACCRAPAN

summary: This is a mutlicentric, open-label non-randomized, national, 1-stage phase II trial to assess efficacy and safety of a weekly Carboplatin-Paclitaxel adjuvant chemotherapy after intensity modulated extended-field chemoradiation in patient suffering from of locally advanced cervical cancer with para-aortic positive nodes.

ReferenceCitation: Shayne M, Crawford J, Dale DC, Culakova E, Lyman GH; ANC Study Group. Predictors of reduced dose intensity in patients with early-stage breast cancer receiving adjuvant chemotherapy. Breast Cancer Res Treat. 2006 Dec;100(3):255-62. Epub 2006 May 17.

ReferenceCitation: Chemoradiotherapy for Cervical Cancer Meta-Analysis Collaboration. Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials. J Clin Oncol. 2008 Dec 10;26(35):5802-12. doi: 10.1200/JCO.2008.16.4368. Epub 2008 Nov 10. Review.

ReferenceCitation: Gouy S, Morice P, Narducci F, Uzan C, Gilmore J, Kolesnikov-Gauthier H, Querleu D, Haie-Meder C, Leblanc E. Nodal-staging surgery for locally advanced cervical cancer in the era of PET. Lancet Oncol. 2012 May;13(5):e212-20. doi: 10.1016/S1470-2045(12)70011-6. Review.

ReferenceCitation: Leblanc E, Narducci F, Frumovitz M, Lesoin A, Castelain B, Baranzelli MC, Taieb S, Fournier C, Querleu D. Therapeutic value of pretherapeutic extraperitoneal laparoscopic staging of locally advanced cervical carcinoma. Gynecol Oncol. 2007 May;105(2):304-11. Epub 2007 Jan 29.

ReferenceCitation: Grigsby PW. The prognostic value of PET and PET/CT in cervical cancer. Cancer Imaging. 2008 Jul 24;8:146-55. doi: 10.1102/1470-7330.2008.0022. Review.

ReferenceCitation: Tsai CS, Chang TC, Lai CH, Tsai CC, Ng KK, Hsueh S, Yen TC, Hong JH. Preliminary report of using FDG-PET to detect extrapelvic lesions in cervical cancer patients with enlarged pelvic lymph nodes on MRI/CT. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1506-12.

ReferenceCitation: Ahmed RS, Kim RY, Duan J, Meleth S, De Los Santos JF, Fiveash JB. IMRT dose escalation for positive para-aortic lymph nodes in patients with locally advanced cervical cancer while reducing dose to bone marrow and other organs at risk. Int J Radiat Oncol Biol Phys. 2004 Oct 1;60(2):505-12.

ReferenceCitation: Rotman M, Pajak TF, Choi K, Clery M, Marcial V, Grigsby PW, Cooper J, John M. Prophylactic extended-field irradiation of para-aortic lymph nodes in stages IIB and bulky IB and IIA cervical carcinomas. Ten-year treatment results of RTOG 79-20. JAMA. 1995 Aug 2;274(5):387-93.

ReferenceCitation: Eifel PJ, Winter K, Morris M, Levenback C, Grigsby PW, Cooper J, Rotman M, Gershenson D, Mutch DG. Pelvic irradiation with concurrent chemotherapy versus pelvic and para-aortic irradiation for high-risk cervical cancer: an update of radiation therapy oncology group trial (RTOG) 90-01. J Clin Oncol. 2004 Mar 1;22(5):872-80.

ReferenceCitation: Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43.

ReferenceCitation: Grigsby PW, Heydon K, Mutch DG, Kim RY, Eifel P. Long-term follow-up of RTOG 92-10: cervical cancer with positive para-aortic lymph nodes. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):982-7.

ReferenceCitation: Mundt AJ, Mell LK, Roeske JC. Preliminary analysis of chronic gastrointestinal toxicity in gynecology patients treated with intensity-modulated whole pelvic radiation therapy. Int J Radiat Oncol Biol Phys. 2003 Aug 1;56(5):1354-60.

ReferenceCitation: Cihoric N, Tapia C, Krüger K, Aebersold DM, Klaeser B, Lössl K. IMRT with ¹⁸FDG-PET\CT based simultaneous integrated boost for treatment of nodal positive cervical cancer. Radiat Oncol. 2014 Mar 25;9:83. doi: 10.1186/1748-717X-9-83.

ReferenceCitation: Vargo JA, Kim H, Choi S, Sukumvanich P, Olawaiye AB, Kelley JL, Edwards RP, Comerci JT, Beriwal S. Extended field intensity modulated radiation therapy with concomitant boost for lymph node-positive cervical cancer: analysis of regional control and recurrence patterns in the positron emission tomography/computed tomography era. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1091-8. doi: 10.1016/j.ijrobp.2014.08.013. Epub 2014 Oct 8.

ReferenceCitation: Perry LJ, Mathews C, Nugent E, Farrell R, Zorn K, Moore K. Outcomes of cervical cancer and positive para-aortic lymph nodes in the modern era of chemoradiation. Int J Gynecol Cancer. 2014 Mar;24(3):564-9. doi: 10.1097/IGC.0000000000000093.

ReferenceCitation: Gouy S, Morice P, Narducci F, Uzan C, Martinez A, Rey A, Bentivegna E, Pautier P, Deandreis D, Querleu D, Haie-Meder C, Leblanc E. Prospective multicenter study evaluating the survival of patients with locally advanced cervical cancer undergoing laparoscopic para-aortic lymphadenectomy before chemoradiotherapy in the era of positron emission tomography imaging. J Clin Oncol. 2013 Aug 20;31(24):3026-33. doi: 10.1200/JCO.2012.47.3520. Epub 2013 Jul 15.

ReferenceCitation: Dueñas-González A, Zarbá JJ, Patel F, Alcedo JC, Beslija S, Casanova L, Pattaranutaporn P, Hameed S, Blair JM, Barraclough H, Orlando M. Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix. J Clin Oncol. 2011 May 1;29(13):1678-85. doi: 10.1200/JCO.2009.25.9663. Epub 2011 Mar 28.

ReferenceCitation: Mabuchi S, Morishige K, Fujita M, Tsutsui T, Sakata M, Enomoto T, Kimura T. The activity of carboplatin and paclitaxel for recurrent cervical cancer after definitive radiotherapy. Gynecol Oncol. 2009 May;113(2):200-4. doi: 10.1016/j.ygyno.2009.02.008. Epub 2009 Mar 6.

ReferenceCitation: Tinker AV, Bhagat K, Swenerton KD, Hoskins PJ. Carboplatin and paclitaxel for advanced and recurrent cervical carcinoma: the British Columbia Cancer Agency experience. Gynecol Oncol. 2005 Jul;98(1):54-8.

ReferenceCitation: Mabuchi S, Morishige K, Enomoto T, Kimura T. Carboplatin and paclitaxel as an initial treatment in patients with stage IVb cervical cancer: a report of 7 cases and a review of the literature. J Gynecol Oncol. 2010 Jun;21(2):93-6. doi: 10.3802/jgo.2010.21.2.93. Epub 2010 Jun 30.

ReferenceCitation: Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer Meta-analysis Collaboration. Neoadjuvant chemotherapy for locally advanced cervical cancer: a systematic review and meta-analysis of individual patient data from 21 randomised trials. Eur J Cancer. 2003 Nov;39(17):2470-86. Review.

ReferenceCitation: McCormack M, Kadalayil L, Hackshaw A, Hall-Craggs MA, Symonds RP, Warwick V, Simonds H, Fernando I, Hammond M, James L, Feeney A, Ledermann JA. A phase II study of weekly neoadjuvant chemotherapy followed by radical chemoradiation for locally advanced cervical cancer. Br J Cancer. 2013 Jun 25;108(12):2464-9. doi: 10.1038/bjc.2013.230. Epub 2013 May 21.

ReferenceCitation: Sparano JA, Wang M, Martino S, Jones V, Perez EA, Saphner T, Wolff AC, Sledge GW Jr, Wood WC, Davidson NE. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med. 2008 Apr 17;358(16):1663-71. doi: 10.1056/NEJMoa0707056. Erratum in: N Engl J Med. 2008 Jul 3;359(1):106. N Engl J Med. 2009 Apr 16;360(16):1685.

ReferenceCitation: ELLIS RE. The distribution of active bone marrow in the adult. Phys Med Biol. 1961 Jan;5:255-8.

ReferenceCitation: Vande Berg BC, Malghem J, Lecouvet FE, Maldague B. Magnetic resonance imaging of the normal bone marrow. Skeletal Radiol. 1998 Sep;27(9):471-83. Review.

ReferenceCitation: Platta CS, Bayliss A, McHaffie D, Tome WA, Straub MR, Bradley KA. A dosimetric analysis of tomotherapy based intensity modulated radiation therapy with and without bone marrow sparing in gynecologic malignancies. Technol Cancer Res Treat. 2013 Feb;12(1):19-29. Epub 2012 Sep 10.

ReferenceCitation: Mell LK, Kochanski JD, Roeske JC, Haslam JJ, Mehta N, Yamada SD, Hurteau JA, Collins YC, Lengyel E, Mundt AJ. Dosimetric predictors of acute hematologic toxicity in cervical cancer patients treated with concurrent cisplatin and intensity-modulated pelvic radiotherapy. Int J Radiat Oncol Biol Phys. 2006 Dec 1;66(5):1356-65. Epub 2006 Jun 6.

ReferenceCitation: Chang Y, Yang ZY, Li GL, Li Q, Yang Q, Fan JQ, Zhao YC, Song YQ, Wu G. Correlations Between Radiation Dose in Bone Marrow and Hematological Toxicity in Patients With Cervical Cancer: A Comparison of 3DCRT, IMRT, and RapidARC. Int J Gynecol Cancer. 2016 May;26(4):770-6. doi: 10.1097/IGC.0000000000000660.

ReferenceCitation: Yang TJ, Oh JH, Apte A, Son CH, Deasy JO, Goodman KA. Clinical and dosimetric predictors of acute hematologic toxicity in rectal cancer patients undergoing chemoradiotherapy. Radiother Oncol. 2014 Oct;113(1):29-34. doi: 10.1016/j.radonc.2014.09.002. Epub 2014 Oct 7.

ReferenceCitation: Lujan AE, Mundt AJ, Yamada SD, Rotmensch J, Roeske JC. Intensity-modulated radiotherapy as a means of reducing dose to bone marrow in gynecologic patients receiving whole pelvic radiotherapy. Int J Radiat Oncol Biol Phys. 2003 Oct 1;57(2):516-21.

ReferenceCitation: Lim K, Small W Jr, Portelance L, Creutzberg C, Jürgenliemk-Schulz IM, Mundt A, Mell LK, Mayr N, Viswanathan A, Jhingran A, Erickson B, De los Santos J, Gaffney D, Yashar C, Beriwal S, Wolfson A, Taylor A, Bosch W, El Naqa I, Fyles A; Gyn IMRT Consortium. Consensus guidelines for delineation of clinical target volume for intensity-modulated pelvic radiotherapy for the definitive treatment of cervix cancer. Int J Radiat Oncol Biol Phys. 2011 Feb 1;79(2):348-55. doi: 10.1016/j.ijrobp.2009.10.075. Epub 2010 May 14.

ReferenceCitation: A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001 Mar 30;20(6):859-66.

lead_sponsor: Centre Oscar Lambret

location_facility:
Clinique des dentellières
Centre Pierre Curie
Centre Oscar Lambret
Centre Marie Curie
Centre Léonard de Vinci


title: A Clinical and Biological Prospective Database of Patients Treated With Anticancer Immunotherapy and Follow up of Their Immune-related Adverse Events irAE

acronym: IMMUCARE-BASE

summary:
The number of patients affected by cancer and treated with immunotherapy is continuously increasing. With the advent of these new therapies, the investigators observe the emergence of new and unexpected toxicities. The care of patients treated with these molecules require the development of multidisciplinary skills and the introduction of a professional network capable of taking care of immunotherapy related toxicity (irAE) that can affect different organs and for which immediate and effective interventions are necessary for patient survival.

IMMUCARE-BASE will comprehensively enable the collection, of clinical and biological data of patients treated with anticancer immunotherapy. The creation of this database is essential to identify clinico-biological factors predisposing to toxicity, and to define the best strategies to prevent the early onset of irAE and/or to treat them. Ultimately, the objective of this database is to collect enough data to be able to personalise in the future the immunotherapy treatment according to the benefits and to anticipate risks for each patient.

The objective of the biological collection is to perform ancillary studies for understanding mechanism leading to toxicity and for the development of research programs in the field of immunotherapy.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Hôpital Pierre Wertheimer
Centre Hospitalier LYON SUD
Hôpital E Herriot
Hôpital L. Pradel
Hôpital de la Croix Rousse


title: Feasibility and Safety of CareMin650 in Cancer Patients at High Risk of or Suffering From Oral Mucositis and/or Radiation Dermatitis Due to the Administration of Radiotherapy: A Prospective Non-comparative Study

acronym: SafePBM

summary: The main objective of the present study is to investigate the feasibility, safety and tolerability of CareMin650 in patients with 1) head & neck cancer at high risk of or suffering from oral mucositis and/or radiation dermatitis due to the administration of radiotherapy with or without chemotherapy with or without targeted therapy, 2) breast cancer at high risk of or suffering from radiation dermatitis due to the administration of radiotherapy.

lead_sponsor: NeoMedLight

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Institut de radiothérapie et radiochirurgie Hartmann


title: Do the Head-elevated Position and the Use of a Videolaryngoscope Facilitate Orotracheal Intubation in a Patient Population Without Predictable Difficulty of Intubation

acronym: HELP-VDL

summary:
The main hypothesis of this study is that there is a synergy between the use of the HELP position and the use of a McGrath® Mac videolaryngoscope to facilitate tracheal intubation during anesthesia.

The HELP position is the patient positioning on the AirPal RAMP, the two cushions inflated, bringing the external auditory canal to the same level as the sus-sternal notch.

ReferenceCitation: Le Guen M, Coppere Z, Dufour G, Ouattara J, Trichereau J, Fischler M. HELP-VDL: study protocol for a multicentre, open, randomised, controlled clinical trial comparing the use of the head-elevated laryngoscopy position and the use of a videolaryngoscope to facilitate orotracheal intubation in a patient population without predictable difficulty of intubation. BMJ Open. 2020 Jul 8;10(7):e036570. doi: 10.1136/bmjopen-2019-036570.

family: Le Guen

full_name: Morgan Le Guen

given: Morgan

family: Coppere

full_name: Zoé Coppere

given: Zoé

family: Dufour

full_name: Guillaume Dufour

given: Guillaume

family: Ouattara

full_name: Jonathan Ouattara

given: Jonathan

family: Trichereau

full_name: Julie Trichereau

given: Julie

family: Fischler

full_name: Marc Fischler

given: Marc

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

repository_institution: PubMed Central - Europe PMC

ipd_sharing_description: Data will be available in the Dryad repository.

lead_sponsor: Hopital Foch

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon


acronym: CHLOROTRAMMEL

location_facility:
INSTITUT Claudius Rigaud
CHU Grenoble Alpes
Centre Hospitalier Lyon Sud
CHU Estaing
AP-HP_HOPITAL Saint Louis

title: MEK and Autophagy Inhibition in Metastatic/Locally Advanced, Unresectable Neuroblastoma RAS (NRAS) Melanoma: A Phase Ib/II Trial of Trametinib Plus Hydroxychloroquine in Patients With NRAS Melanoma

summary:
Patients with metastatic Neuroblastoma RAS (NRAS) melanoma are currently treated with first line immune checkpoint inhibitors (nivolumab, pembrolizumab). Thus far, no targeted therapy has been approved in NRAS mutated melanoma as a second line treatment, because although the use of a MEK inhibitor (binimetinib) alone was superior to the gold standard chemotherapy (dacarbazine) in a phase 3 trial, the progression free survival gain was very modest.

In vitro and in vivo work from the study team's lab (McMAHON, Huntsman Cancer Institute (HCI), Salt Lake City), as well as, Ravi Amaravardi and Jean Mulchey-Levy suggests that the activation of autophagy is a mechanism of resistance to BRAF and MEK inhibitors in RAS and RAF mutated cancers, such as melanoma, pediatric brain tumors and pancreatic adenocarcinoma. The study team has shown in vivo, in four different NRAS mutated melanoma Patient Derived Xenograft (PDX) models that the combination of the MEK inhibitor trametinib and the autophagy inhibitor chloroquine results in a more dramatic tumor regression and inhibition than trametinib or chloroquine used as single agents (Nat Med. 2019 Apr;25(4):620-627. doi: 10.1038/s41591-019-0367-9. Epub 2019 Mar 4). In two of the PDX models, the combination resulted in almost complete tumor regression (quasi disappearance) that was not observed in the single agent treatment arms.

Trametinib (MEKINISTR) is an orally available MEK inhibitor that is currently approved in combination with the BRAF inhibitor dabrafenib (TAFINLARR) to treat BRAF mutated metastatic melanoma at the standard dosing of 2 milligrams (mg) once a day. Hydroxychloroquine (PLAQUENILR) is an orally available autophagy inhibitor that has been used for many years to treat autoimmune diseases like lupus, sarcoidosis and rheumatoid arthritis at the standard dosing of 400-600mg/day. For this study, the investigating team would like to evaluate the safety and tolerability of the combination of hydroxychloroquine and trametinib in a phase I trial in patients with NRAS mutated metastatic melanoma.


title: Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Advanced Pancreatic Adenocarcinoma (ALIX)

acronym: ALIX

summary:
Current standard of care for patients with metastatic Pancreatic Ductal AdenoCarcinoma (PDAC) is chemotherapy, preferential regimen being FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin). Due to more hematologic (neutropenia) and gastrointestinal toxicities, FOLFIRINOX is only administered in fit patients (age < 75 years, ECOG Performance status 0-1, and bilirubin < 1.5 ULN).

However, elderly or frail patients represent more than half of patients with PDAC and are treated with gemcitabine monochemotherapy. Maintaining more than one drug (polychemotherapy) may improve survival and quality of life in this population.

ALIX is a non-comparative randomized 2:1 phase II study. This study will assess the efficacy and safety of the polychemotherapy with XELOXIRI-3 versus gemcitabine as first-line chemotherapy in elderly or frail patients with locally advanced or metastatic PDAC.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
University Hospital of Besançon
CHU Reims
CH Mulhouse
CHU Nancy
Hôpital Nord Franche-Comté


title: Interest of Implantable Cardioverter-defibrillator in Primary Prevention in Patient With Continuous Flow Left Ventricular Assist Device (CF-LVAD)

acronym: ASSIST-ICD

summary: Determination of risk factors of ventricular arrhythmias (VAs) after implantation of continuous flow left ventricular assist device in order to characterize which patient requires ICD implantation in primary prevention.

ReferenceCitation: Charton M, Flécher E, Leclercq C, Delmas C, Dambrin C, Goeminne C, Vincentelli A, Michel M, Lehelias L, Verdonk C, Para M, Pozzi M, Obadia JF, Boignard A, Chavanon O, Barandon L, Nubret K, Kindo M, Minh TH, Gaudard P, Pelcé E, Gariboldi V, Litzler PY, Anselme F, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Lellouche N, Bourguignon T, Genet T, Eschalier R, D'Ostrevy N, Bories MC, Jouan J, Vanhuyse F, Blangy H, Doucerain J, Martins RP, Galand V. Suicide Attempts Among LVAD Recipients: Real-Life Data From the ASSIST-ICD Study. Circulation. 2020 Mar 17;141(11):934-936. doi: 10.1161/CIRCULATIONAHA.119.041910. Epub 2020 Mar 10.

name: INSERM, LTSI-UMR 1099, Univ Rennes (M.C., E.F., C.L., R.P.M., V. Galand), CHU Rennes, France.

family: Charton

full_name: Marion Charton

given: Marion

name: Department of Cardiac Surgery and Heart Transplantation Unit (E.F.), CHU Rennes, France.

family: Flécher

full_name: Erwan Flécher

given: Erwan

family: Leclercq

full_name: Christophe Leclercq

given: Christophe

name: Centre Hospitalier Universitaire de Toulouse, France (C. Delmas, C. Dambrin).

family: Delmas

full_name: Clément Delmas

given: Clément

family: Dambrin

full_name: Camille Dambrin

given: Camille

name: Department of Cardiac Surgery, Cardiology, Cardiac Intensive Care Unit, Institut Coeur-Poumons, CHU Lille, France (C.G., A.V.).

family: Goeminne

full_name: Céline Goeminne

given: Céline

family: Vincentelli

full_name: André Vincentelli

given: André

name: Department of Cardiology and Heart Transplantation Unit, CHU Nantes, France (M.M., L.L.).

family: Michel

full_name: Magali Michel

given: Magali

family: Lehelias

full_name: Laurence Lehelias

given: Laurence

name: Department of Cardiology and Cardiac Surgery, Bichat-Hospital, Paris, France (C.V., M. Para).

family: Verdonk

full_name: Constance Verdonk

family: Para

full_name: Marylou Para

given: Marylou

name: Department of Cardiac Surgery, Louis Pradel Cardiologic Hospital, Lyon, France (M. Pozzi, J.-F.O.).

family: Pozzi

full_name: Matteo Pozzi

given: Matteo

family: Obadia

full_name: Jean-François Obadia

given: Jean-François

name: Department of Cardiology and Cardiovascular Surgery, CHU Michallon, Grenoble, France (A.B., O.C.).

family: Boignard

full_name: Aude Boignard

given: Aude

family: Chavanon

full_name: Olivier Chavanon

given: Olivier

name: Hôpital Cardiologique du Haut-Lévêque, Université Bordeaux II, France (L.B., K.N.).

family: Barandon

full_name: Laurent Barandon

given: Laurent

family: Nubret

full_name: Karine Nubret

given: Karine

name: Département de Chirurgie Cardiovasculaire, Hôpitaux Universitaires de Strasbourg, France (M.K., T.H.M.).

family: Kindo

full_name: Michel Kindo

given: Michel

family: Minh

full_name: Tam Hoang Minh

given: Tam Hoang

name: PhyMedExp, Université de Montpellier, INSERM, CNRS, Arnaud De Villeneuve Department of Anesthesiology and Critical Care Medicine, CHU Montpellier, France (P.G.).

family: Gaudard

full_name: Philippe Gaudard

given: Philippe

name: Department of Cardiac Surgery, La Timone Hospital, Marseille, France (E.P., V. Gariboldi).

family: Pelcé

full_name: Edeline Pelcé

given: Edeline

family: Gariboldi

full_name: Vlad Gariboldi

given: Vlad

name: Department of Cardiology and Cardiovascular Surgery, Hospital Charles Nicolle, Rouen, France (P.-Y.L., F.A.).

family: Litzler

full_name: Pierre-Yves Litzler

given: Pierre-Yves

family: Anselme

name: Department of Cardiology and Cardiac Surgery, University of Caen and University Hospital of Caen, France (G.B., A.B.).

name: Department of Cardiology and Cardiac Surgery, University Hospital, Dijon, France (F.G., M.B.).

name: Department of Cardiology and Cardiac Surgery, AP-HP CHU Henri Mondor, Créteil, France (D.H., N.L.).

name: Department of Cardiology and Cardiac Surgery, Tours University Hospital, France (T.B., T.G.).

name: CHU Clermont-Ferrand, Cardiology Department, Clermont-Ferrand, France (R.E., N.D.).

name: European Georges Pompidou Hospital, Cardiology Department, Paris, France (M.-C.B., J.J.).

name: Department of Cardiology and Cardiac Surgery, CHU de Nancy, Hopital de Brabois, Nancy, France (F.V., H.B.).

name: Service de Psychiatrie (J.D.), CHU Rennes, France.

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

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

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Suicide Attempts Among LVAD Recipients

ReferenceCitation: Galand V, Flécher E, Auffret V, Pichard C, Boulé S, Vincentelli A, Rollin A, Mondoly P, Barandon L, Pernot M, Kindo M, Cardi T, Gaudard P, Rouvière P, Sénage T, Jacob N, Defaye P, Chavanon O, Verdonk C, Ghodbane W, Pelcé E, Gariboldi V, Pozzi M, Obadia JF, Savouré A, Anselme F, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Lellouche N, Pierre B, Bourguignon T, Eschalier R, D'Ostrevy N, Bories MC, Marijon E, Vanhuyse F, Blangy H, Verhoye JP, Leclercq C, Martins RP. Early Ventricular Arrhythmias After LVAD Implantation Is the Strongest Predictor of 30-Day Post-Operative Mortality. JACC Clin Electrophysiol. 2019 Aug;5(8):944-954. doi: 10.1016/j.jacep.2019.05.025. Epub 2019 Aug 19.

ReferenceCitation: Martins RP, Leclercq C, Bourenane H, Auffret V, Boulé S, Loobuyck V, Dambrin C, Mondoly P, Sacher F, Bordachar P, Kindo M, Cardi T, Gaudard P, Rouvière P, Michel M, Gourraud JB, Defaye P, Chavanon O, Kerneis C, Ghodhbane W, Pelcé E, Gariboldi V, Pozzi M, Grinberg D, Litzler PY, Anselme F, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Lellouche N, Pierre B, Bourguignon T, Eschallier R, D'Ostrevy N, Bories MC, Jouan J, Vanhuyse F, Sadoul N, Flécher E, Galand V. Incidence, predictors, and clinical impact of electrical storm in patients with left ventricular assist devices: New insights from the ASSIST-ICD study. Heart Rhythm. 2019 Oct;16(10):1506-1512. doi: 10.1016/j.hrthm.2019.06.021. Epub 2019 Jun 27.

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

ReferenceCitation: Tattevin P, Flécher E, Auffret V, Leclercq C, Boulé S, Vincentelli A, Dambrin C, Delmas C, Barandon L, Veniard V, Kindo M, Cardi T, Gaudard P, Rouvière P, Sénage T, Jacob N, Defaye P, Chavanon O, Verdonk C, Para M, Pelcé E, Gariboldi V, Pozzi M, Grinberg D, Savouré A, Litzler PY, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Lellouche N, Bernard L, Bourguignon T, Eschalier R, D'Ostrevy N, Jouan J, Varlet E, Vanhuyse F, Blangy H, Martins RP, Galand V. Risk factors and prognostic impact of left ventricular assist device-associated infections. Am Heart J. 2019 Aug;214:69-76. doi: 10.1016/j.ahj.2019.04.021. Epub 2019 May 6.

title: Risk factors and prognostic impact of left ventricular assist device–associated infections

ReferenceCitation: Galand V, Flécher E, Auffret V, Boulé S, Vincentelli A, Dambrin C, Mondoly P, Sacher F, Nubret K, Kindo M, Cardi T, Gaudard P, Rouvière P, Michel M, Gourraud JB, Defaye P, Chavanon O, Verdonk C, Ghodbane W, Pelcé E, Gariboldi V, Pozzi M, Obadia JF, Litzler PY, Anselme F, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Radu C, Pierre B, Bourguignon T, Eschalier R, D'Ostrevy N, Bories MC, Marijon E, Vanhuyse F, Blangy H, Verhoye JP, Leclercq C, Martins RP; ASSIST-ICD Investigators. Predictors and Clinical Impact of Late Ventricular Arrhythmias in Patients With Continuous-Flow Left Ventricular Assist Devices. JACC Clin Electrophysiol. 2018 Sep;4(9):1166-1175. doi: 10.1016/j.jacep.2018.05.006. Epub 2018 Jul 25.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

location_facility: Hospices Civils de Lyon - Hôpital Louis Pradel


title: Transcultural Validation of MSTS and TESS Questionnaire

acronym: MSTS-TESS

summary:
Reference treatment for soft tissue or bone sarcoma is the Monobloc resection surgery, with a margin of one to many millimeters removing the entire tumor leaving no cancer cells, associated or not with other treatments. Other musculoskeletal malignant tumors, some of them with secondary origins (metastases), are treated the same way. Patients with soft tissue and bone tumor could have heavy sequels of this surgery procedure, depending on the localization and size of the initial tumor. Those functional sequels are evaluated by specific questionnaires: the questionnaire TESS for upper limbs and TESS for lower limbs which are completed by the patient (depending on the localization of the tumor) and the questionnaire MSTS which is completed by the medical doctor.

Those English validated questionnaires are frequently used by French surgeons in standard practice as well as scientific research. The translations done have never been validated by an official methodology.

The aim of this trial is to validate the TESS and MSTS questionnaires linguistically, culturally (questions must be adapted for each target population: occidental adults and adolescents population, male and female population and adapted to the current era), and scientifically (repeatability).

The validation of those questionnaires will permit to have functional and reference questionnaires in French language which could be used for the follow up of operated patient in the context of the care and clinical research.

location_facility:
Nantes University hospital
Rennes University Hospital
Marseille University Hospital
Tours University Hospital
Nantes University Hospital


acronym: EFESE

summary:
Despite advances in early detection and treatment strategy, about 25 to 40% of patients treated for breast cancer develop metastasis.

Some patients are in a therapeutic impasse situation. It is therefore necessary to consider all possible options. The Estramustine showed encouraging results in the treatment of metastatic breast cancer.

Given the clinical data, the answer rate of Estramustine and its impact on progression free survival deserve to be studied in earlier clinical situation.

This Phase II study evaluated the efficacy of Estramustine in women with breast cancer and metastates, already treated with aromatase inhibitors and for whom this treatment has failed.

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
CLCC Val d'Aurel
CHU Tenon
Institut de Cancérologie de Lorraine
Centre Antoine Lacassagne
Polyclinique Courlancy Reims
Institut Jean Godinot
CHU Avicenne
CHBM Site du Mittan
Polyclinique Bordeaux Nord Aquitaine
Clinique armoricaine
CHRU Brest
CLCC Léon Bérard
Centre Paul Strauss
CHU Besançon-Jean Minjoz
Clinique Sainte Anne
Centre Catherine de Sienne
Centre O. Lambret
Hôpital Privé Clairval
Institut Sainte Catherine
Hôpital Européen Georges Pompidou
Polyclinique de Blois


title: Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses

acronym: CIRCA-HPV

summary: ctDNA detection in patients with previously treated, HPV-induced, stage II or III invasive pelvic cancer and who are currently in post-treatment follow-up.

lead_sponsor: Institut Curie

location_facility:
Hôpital Tenon
CHU Pontchaillou
Institut Curie - Saint-Cloud
Institut Curie - Paris
CHU de Besançon


lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

acronym: PREDIRESPUC

location_facility:
Chu L'Archet
Ch Lyon Sud
CHU Saint-Etienne
CHU Kremlin Bicêtre
CHU Amiens

title: Value of Pharmacokinetic Assays (Vedolizumab and Anti-vedolizumab Antibody) in the Prediction of Induction and Maintenance Therapeutic Response in Ulcerative Colitis

summary: Vedolizumab (VDZ) is a monoclonal antibody that binds to the heterodimer α4β7 integrin and which has shown its efficacy in Ulcerative Colitis (UC) by inducing and maintaining clinical response/remission. The French marketing authorization was obtained for Ulcerative Colitis in patients in failure with anti-Tumor Necrosis Factor (anti-TNF) agents. In the pivotal study, correlation between drug levels and clinical response during induction and maintenance therapy were reported. Moreover, in 3.7% of cases, anti-vedolizumab antibodies were reported during the time-course and 1% had samples that were persistently positive. Up to now, data on the pharmacologic VDZ parameters are scarce and the relationships as well as the predictive value of the measurement of VDZ concentrations and VDZ monoclonal antibodies (mAbs) during the induction and maintenance phases remains unknown. It could be of paramount interest to early identify UC patients under VDZ who will be responders to VDZ induction and to identify those who will achieve clinical remission under maintenance therapy with VDZ.


title: Identification of Genetic Markers Modulating Rhythmic Risk Among Patients With Severe Cardiomyopathy

acronym: GENECHOC

summary: The aim of this project is to identify common genetic polymorphisms associated with the occurrence of rhythmic events in patients with severe cardiomyopathy.

location_facility:
CHU Angers
CHU Marseille
CHRU Lille
CHU Rennes
CHU Toulouse
CHU Clermont-Ferrand.
CHU Lyon
CHRU Strasbourg
CHU Bordeaux
CHU Montpellier
CHU Tours
CHU Dijon
CHU Grenoble
CHU Nantes
CHU Nancy
CHU Rouen
CHU Brest
CH La Rochelle

intervention_type: Genetic


title: An Open-Label, Multicenter, Randomized, Phase II Study to Evaluate the Efficacy and Safety of Two Combination Dose Regimens: Capecitabine + Epirubicin + Cyclophosphamide (CEX) Versus 5-FU + Epirubicin + Cyclophosphamide (FEC 100) as Neoadjuvant Therapy in Females Presenting With Operable Breast Cancer

summary: This study will evaluate the efficacy and safety of treatment with oral capecitabine or intravenous (IV) 5-fluorouracil (5-FU), in combination with epirubicin and cyclophosphamide, prior to surgery in participants with breast cancer. The participants will receive 4 cycles of neoadjuvant Capecitabine + Epirubicin + Cyclophosphamide (CEX) or 5-FU + Epirubicin + Cyclophosphamide (FEC 100) chemotherapy during first treatment period (Period 1, Days 1-85). After 4-6 weeks of the fourth cycle of neoadjuvant chemotherapy (Day 120 +/- 7 days), breast surgery with regional lymph node dissection will be performed, followed within a maximum of 6 weeks by the second treatment period (Period 2, Days 1 to 85) when participants in both study arms will receive 4 cycles of adjuvant docetaxel 100 milligrams per meter square (mg/m^2) by IV infusion on Day 1 of each 21-day cycle. Upon completion of the second treatment period, participants will enter the post-treatment follow-up period which will last for 5 years from the initial date of participant randomization. During this period participants will be evaluated once a year on the anniversary date of randomization.

lead_sponsor: Hoffmann-La Roche


title: Identification of Biopsychosocial Factors Predictive of the Post-traumatic Stress Disorder Occurrence in Patients Admitted to the Emergencies After Trauma

acronym: ISSUE

summary:
After trauma or stress factor like death exposition, serious injuries or sexual violence, some patients may develop stress reaction characterized by the presence of various symptoms among different categories (reviviscence, negative humor, dissociates symptoms, occasion, hypervigilance). In the month following trauma, the investigators speak of acute stress reaction (ASR) when symptoms are present during at least three days. If symptoms are present one month after trauma, then it is a post-traumatic stress disorder (PTSD).

Among patients visiting emergency after latest trauma, quite a few is in acute stress reaction. However, this reaction is often incorrectly identified by healthcare team, due to lack of oriented medical examination, patients visiting about other complaints (pain, insomnia) and not expressing clearly the trauma context. Yet, it is know that acute stress reaction occurrence and existence of dissociate symptoms after trauma confrontation is considerably predictive of the eventual post-traumatic stress disorder occurrence.

The identification of risk population of post-traumatic stress disorder is not the subject of any particular structured procedure in emergency services while early care of these patients may allow limiting post-traumatic stress disorder occurrence and associate consequences. Previous works on the subject having exclusively targeted some trauma subgroups or some predictive factors subtypes, investigators propose here biopsychosocial global approach that can weight the impact of each parameters.

In this study, investigators aim at determining predictive biopsychosocial factors of the post-traumatic stress disorder occurrence at 3 months in patients visiting emergency after latest trauma (less than one month old) and identified as "high-risk" to develop post-traumatic stress disorder (moderate or high).

ReferenceCitation: Wafa MH, Viprey M, Magaud L, Haesebaert J, Leaune E, Poulet E, Bied C, Schott AM. Identification of biopSychoSocial factors predictive of post-traUmatic stress disorder in patients admitted to the Emergency department after a trauma (ISSUE): protocol for a multicenter prospective study. BMC Psychiatry. 2019 May 30;19(1):163. doi: 10.1186/s12888-019-2154-z.

apc_source: openAPC

family: Wafa

full_name: Mohammad-Hashim Wafa

given: Mohammad-Hashim

family: Viprey

full_name: Marie Viprey

given: Marie

family: Magaud

full_name: Laurent Magaud

family: Haesebaert

full_name: Julie Haesebaert

given: Julie

family: Leaune

full_name: Edouard Leaune

given: Edouard

family: Poulet

full_name: Emmanuel Poulet

given: Emmanuel

family: Bied

full_name: Clemence Bied

given: Clemence

family: Schott

full_name: Anne-Marie Schott

given: Anne-Marie

journal_name: BMC Psychiatry

license: cc-by

license_normalized: cc-by

repository_normalized: HAL

repositories:
HAL
PubMed Central

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

location_facility: Centre Hospitalier Lyon Sud - Urgences psychiatriques

location_facility: CHU St Etienne - Hôpital Nord - Urgences Psychiatriques

location_facility: CH St Joseph St Luc - Urgences Psychiatriques et Médecine d'urgence

location_facility: Hôpital Edouard Herriot - Urgences Psychiatrique et Médecine d'urgence

location_facility: CHU Clermont - Hôpital G Montpied - Urgences Psychiatriques et Médecine d'urgence