title: Early Echographic Asystole as a Predictive Factor of Absence of Spontaneous Circulatory Activity Recovery (SCAR) in Prehospital Cardio Respiratory Arrests (CRA) - ACE Study

acronym: ACE

summary:
Assessment of prognostic performances of CCU in CRA Recovery (CRAR) has already been explored but 1) Only in intra-hospital medicine, 2) in very variable timings. ACE Research focuses on the extra-hospital window and predictive value of Early CCU (within 12 minutes of rescucitation initiation) with ambitious endpoints : curable etiologies identification, early anticipation of ECMO procedures, early anticipation of organ donation process, and evaluation of intrinsic contribution criterion to resuscitation interruption.

The primary objective of ACE study is to investigate the positive predictive value (PPV) of early ultrasound asystole on the absence of CRAR. The secondary objectives are multiple and innovative despite an observational design: impact on the morbi-mortality of the target population (frequency of curable etiologies, pre-therapeutic and therapeutic delays, morbidity...), delay of ECMO implementation of an ECMO (Extracorporeal Membrane Oxygenation), failure rate of organ donation due to overdelays, construction of a multifactorial score associated with CRAR.

ReferenceCitation: Javaudin F, Pes P, Montassier E, Legrand A, Ordureau A, Volteau C, Arnaudet I, Le Conte P. Early point-of-care focused echocardiographic asystole as a predictive factor for absence of return of spontaneous circulatory in out-of-hospital cardiac arrests: a study protocol for a prospective, multicentre observational study. BMJ Open. 2019 Aug 30;9(8):e027448. doi: 10.1136/bmjopen-2018-027448.

family: Javaudin

full_name: François Javaudin

given: François

family: Pes

full_name: Philippe Pes

given: Philippe

family: Montassier

full_name: Emmanuel Montassier

given: Emmanuel

family: Legrand

full_name: Arnaud Legrand

given: Arnaud

family: Ordureau

full_name: Aline Ordureau

given: Aline

family: Volteau

full_name: Christelle Volteau

given: Christelle

family: Arnaudet

full_name: Idriss Arnaudet

given: Idriss

family: Le Conte

full_name: Philippe Le Conte

journal_name: BMJ Open

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:
Chru Brest
Chu Angers
Chd Vendee
CH Saint-Nazaire
Chru Tours
Nantes University Hospital
Ch Chateaubriant


type: Other Identifier

title: Oral Evaluation by the Nurses From the Office of Access to Healthcare ("PASS") for Vulnerable People as a Vector for the Detection of Oral Diseases to Improve Access to the Appropriate Healthcare Branch - PASSDENT Study

acronym: PASSDENT

summary:
Oral health is defined as the state of being free from dental or periodontal diseases and discomfort of oral cavity. WHO considers that oral hygiene is a major public health problem whatever the countries (developed, developing, and underdeveloped).

The two main local medical problems are dental caries and periodontal diseases. Without appropriate treatments, both diseases can lead to local functional and esthetic damages, and can also have some negative repercussions on health.

Studies showed that there are great social disparities among people concerned by oral health issues. People in vulnerable situations (homeless and low incomes people, refugees) had less recourse to dental care. Those who consult do it less often and later. Reasons are mainly cost related, but also people in vulnerable situation don't perceive dental care as an important matter and don't know where and how to ask for help for having dental care.

PASS (french acronym for "Office of Access to Healthcare") departments, setting in both private and public health institutions, are intended to facilitate the access to care and the support of people in vulnerable situations, and their accompaniment in the steps necessary for the recognition of their rights.

Nurses of the Annecy PASS department had developed a questionnaire called "healthplan guide" that aim at helping them to screen and identify people with dental diseases among those in vulnerable situation, and to sensitize them about the importance of oral hygiene and how to improve it. This questionnaire is use in daily practice.

This study hypothesizes that more patients will be sensitized to benefit a dental examination in a dental practice if nurses use the "healthplan guide" questionnaire combined with an oral and dental evaluation.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Hospitalier Annecy Genevois

location_facility: Centre d'hébergement et de réinsertion sociale Saint-François

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


type: EudraCT Number

title: A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors

acronym: REGOMUNE

summary:
Assessment of the efficacy and safety of Regorafenib and Avelumab in patients with advanced or metastatic solid tumors (ten cohorts), once the Recommanded Phase II Dose (RP2D) has been determined (phase I trial).

Assessement of the efficacy and safety of a low-dose of regorafenib (80mg/day) with avelumab in patients with advanced or metastatic colorectal tumors.

status: Recruiting

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: Institut Bergonié

location_facility: Centre Hospitalier Régional Universitaire - CHU Morvan

location_facility: IUCT Oncopôle - Institut Claudius Regaud

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


status: Terminated

lead_sponsor: Alfasigma S.p.A.

enrollment_type: Actual

location_country:
Italy
Netherlands
France
Spain
Germany
United Kingdom

acronym: ROAD

location_facility: Yeovil District Hospital NHS Trust Department of Surgery

location_facility: Ospedale Buccheri La Ferla Fetebenefratelli Unità Operativa di Gastroenterologia e Endoscopia Digestiva

location_facility: AOU Seconda Università degli Studi di Napoli Unità Operativa Complessa di Epato-Gastroenterologia

location_facility: Ospedale Cardinal Massaia SOC Gastroenterologia ed Endoscopia Digestiva

location_facility: Azienda Ospedaliera Universitaria Integrata - UOC Gastroenterologia A- Borgo Trento-Dipartimento Medicina Generale

location_facility: Azienda Ospedaliera Policlinico Consorziale di Bari Dipartimento di Gastroenterologia

location_facility: Ospedale San Gerardo Endoscopia Digestiva

location_facility: Hospital Costa del Sol Servicio Digestivo

location_facility: Ospedale Sant'Anna Unità Operativa di Medicina Interna

location_facility: Hospital Clínic Servicio de Gastroenterología

location_facility: Policlinico Universitario Campus Biomedico Unità Operativa Complessa di Gastroenterologia ed Endoscopia Digestiva

location_facility: Hospital de Ourense Servicio de Aparato Digestivo

location_facility: Ospedale Civile San Giovanni di Dio - Divisione di Gastroenterologia ed Endoscopia Digestiva

location_facility: Ospedale S. Salvatore di L'Aquila Unità Operativa di Gastroenterologia, Epatologia e Nutrizione

location_facility: PO Cisanello - AOU Pisana Unità Operativa Complessa di Gastroenterologia - AOUP Gastroenterologia Universitaria

location_facility: Policlinico Ss Annunziata - ASL 2 Lanciano Vasto Chieti UOSD Endoscopia Digestiva

location_facility: Ospedale Valduce Unità Operativa Complessa di Gastroenterologia

location_facility: Ospedale Policlinico S.Martino Istituto di Ricovero e Cura per l'Oncologia Dipartimento di Medicina Interna e Specialità Mediche U.O. Clinica Gastroenterologica

location_facility: Fondazione Policlinico Universitario A. Gemelli Unità Operativa Complessa di Gastroenterologia e Malattie del Fegato

location_facility: Centre Hospitalier Universitaire (CHU) de Strasbourg Service de Chirurgie Digestive et Endocrinienne

location_facility: CHU Nantes, Hôtel Dieu Clinique de Chirurgie digestive et endocrinienne (CCDE) Institut des maladies de l'Appareil Digestif (IMAD)

location_facility: Ospedale Sant'Andrea - Gastroenterologia

location_facility: Ospedale di Circolo e Fondazione Macchi Endoscopia

location_facility: AOU di Bologna - Policlinico S.Orsola Malpighi - Dipartimento di Scienze Mediche e Chirurgiche

location_facility: Policlinico Federico II - UOSD Diagnosi Fisiopatologica e Terapia delle Malattie Motorie Digestive

location_facility: Ospedale Popoli Unità Operativa Semplice Dipartimentale Chirurgia Endoscopica

location_facility: Hospital General Universitario de Alicante Servicio de Aparato Digestivo

location_facility: Ente Ospedaliero Ospedali Galliera Chirurgia Generale

location_facility: Hospital Universitario de Canarias Servicio de Gastroenterología

location_facility: Ospedale "San Paolo" - Unità Operativa Complessa di Gastroenterologia ed Endoscopia Digestiva

location_facility: Azienda Ospedaliera San Giovanni Addolorata Gastroenterologia ed Endoscopia Digestiva

location_facility: IRCCS Policlinico San Donato Unità Operativa Medicina Generale III, Gastroenterologia

location_facility: Hospital Clínico Universitario Lozano Blesa Servicio de Aparato Digestivo

location_facility: Hôpital Saint-Joseph Service Hépato-Gastroentérologie

location_facility: Ospedale Civile S. Agostino Estense - Divisione di Endoscopia Digestiva

location_facility: Azienda Ospedaliera Garibaldi Unità Operativa Complessa di Gastroenterologia

location_facility: AOU di Padova Unità Operativa Complessa di Gastroenterologia

location_facility: Ospedale Ciaccio - De Lellis Divisione di Gastroenterologia ed Endoscopia Digestiva

location_facility: Hôpital Charles Nicolle - CHU Rouen Service Hépato-Gastroentérologie

location_facility: Centre Hospitalier Regional Universitaire Claude Huriez Service de Chirurgie Digestive et Générale

location_facility: Centre Médic Teknon Servicio de Aparato Digestivo

location_facility: AOU OO. RR. San Giovanni di Dio e Ruggi d'Aragona - Dipartimento di Medicina e Chirurgia - Gastroenterologia

location_facility: AOU Cagliari - Policlinico Monserrato Gastroenterologia

location_facility: Azienda Ospedaliera San Giovanni Battista Molinette - S.C. Gastroenterologia e Epatologia

location_facility: UNIMI - San Paolo (ASST Santi Paolo e Carlo) Medicina Generale

location_facility: Fondazione IRCCS Policlinico San Matteo Dipartimento di Medicina Interna

location_facility: Hôpital Avicenne Service Gastro-entérologie

location_facility: Università degli Studi di Bari Policlinico Medicina Interna

location_facility: Hospital Universitario de Belltvitge Servicio de Cirugía General y Digestiva

location_facility: Hospital General San Jorge de Huesca Servicio de Aparato Digestivo

location_facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

location_facility: Istituto Clinico Humanitas-Unità Operativa Malattie Infiammatorie Croniche Intestinali

location_facility: Ospedale Cristo Re - Divisione di Medicina Interna e Gastroenterologia

location_facility: Hospital Vall d'Hebrón Servicio de Aparato Digestivo

location_facility: Policlinico Federico II - UO di Epatogastroenterologia ed endoscopia digestiva

study_completion_date_type: Actual

source: euctr

title: Rifaximin Delayed Release (400 mg Tablet) for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications. A Phase II, Multicenter, Double-blind, Placebo-controlled, Randomized Clinical Trial

summary:
Colonic microbiota changes may play a key role in the pathogenesis of acute diverticulitis. A previous proof-of-concept study suggests that rifaximin, a low-absorbable oral antibiotic, may be beneficial for prevention of acute diverticulitis recurrence by modulating the gut microflora.

The main objective of this study is to evaluate the safety and efficacy of two different doses of a delayed release formulation of rifaximin, versus placebo, for the prevention of recurrence of acute diverticulitis and diverticular complications in patients with a recent episode of acute diverticulitis.


title: Evaluation of the Serum Markers sFLt1 and PlGF for the Prediction of the Complications of the Placental Vascular Pathologies in the 3rd Quarter of the Pregnancy.

acronym: PRECOPE

summary:
The pre-eclampsia is a frequent pathology, concerning approximately 5 % of the pregnancies.The pre-eclampsia can evolve into severe maternal and\or foetal complications and is a major cause of mortality.

The purpose of the study will to estimate the relevance of the serum markers sFlt1 and PlGF to predict the arisen of severe complications at these patients, what would allow to decrease the materno-fœtale morbi-mortality due to the pathology.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Metropole Savoie

location_facility:
CHMetropoleSavoie
Centre Hospitalier Alpes Léman
CHU de Limoges
Groupe Hospitalier du Havre
Hôpitaux du Léman
CHU de Brest
Centre Hospitalier Annecy Genevois

intervention_type: Diagnostic Test


title: A Phase II, Multicenter, Open Label Study Evaluating the Efficacy and the Tolerance of Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia (MTSA)

acronym: MTSA

summary: This study aims at evaluating the safety and the tolerance of the micro-transplantation in elderly patients with acute myeloid leukemia who are ineligible to conventional allogeneic transplantation.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire de Grenoble


title: Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma: a Multicentric Single-arm Phase II Study

summary: We hypothesized that intra-arterial gemcitabine/oxaliplatin administered as second-line treatment could strongly improve objective response rate at 4 months after inclusion in patient with non-metastatic unresectable intra-hepatic cholangiocarcinoma.

lead_sponsor: University Hospital, Montpellier

location_facility:
Institut Gustave Roussy
Uhmontpellier
Centre Georges François Leclerc
Amiens University Hospital
Angers University Hospital
Hôpital Européen Georges Pompidou
Bordeaux University Hospital

intervention_type: Procedure


acronym: ECHANGE

summary:
Prenancy and specialy delivery for hemophilia mother and her children possibly hemophilia is risked.

Diagnostical of hemophilia pregnan is the first difficulty but patients with hemorrhagic menstruation without etiology known, hemorrhagic complication during a chirurgical procedure or during previously pregnancy currently are examine in Haemostasis consultation.

None French recommendation specifie for health practice of these hemophilia patients exists. However, Anglo-Saxon recommendations are published in 2011.

The objective of this study is to realize a French investigation of health practice about hemophilia care of these patients and to compare them with the English reference table.

status: Completed

time_perspective: Retrospective

ReferenceType: derived

ReferenceCitation: Nau A, Gillet B, Guillet B, Beurrier P, Ardillon L, Cussac V, Guillou S, Raj L, Trossaërt M, Horvais V, Bayart S, Potin J, Rose J, Macchi L, Couturaud F, Lacut K, Pan-Petesch B. Bleeding complications during pregnancy and delivery in haemophilia carriers and their neonates in Western France: An observational study. Haemophilia. 2020 Nov;26(6):1046-1055. doi: 10.1111/hae.14117. Epub 2020 Aug 25.

name: Département de Médecine Interne Pneumologie et Médecine VasculaireCHU Brest Brest France

family: Nau

full_name: Alice Nau

given: Alice

sequence: first

name: Centre de traitement de l'hémophilie CHU Hôtel‐Dieu Nantes Nantes France

family: Gillet

full_name: Benjamin Gillet

given: Benjamin

sequence: additional

name: Centre de traitement des maladies hémorragiques CHU Rennes Rennes France

name: INSERM, U1085IRSETUniversité Rennes 1 Rennes France

family: Guillet

full_name: Benoît Guillet

given: Benoît

name: Centre de traitement de l'hémophilie CHU Angers Angers France

family: Beurrier

full_name: Philippe Beurrier

name: Service d'hématologie ‐ hémostase Hôpital TrousseauCHU Tours Tours France

family: Ardillon

full_name: Laurent Ardillon

given: Laurent

name: Laboratoire d'hématologieCH Le Mans Le Mans France

family: Cussac

full_name: Vincent Cussac

given: Vincent

name: Service d'hématologie biologique CHU Poitiers Poitiers France

name: INSERMU1082IRTOMITUniversité de Poitiers Poitiers France

family: Guillou

full_name: Sophie Guillou

given: Sophie

name: EA3878 Université de Bretagne Occidentale Brest France

family: Raj

full_name: Leela Raj

given: Leela

family: Trossaërt

full_name: Marc Trossaërt

given: Marc

family: Horvais

full_name: Valérie Horvais

given: Valérie

family: Bayart

full_name: Sophie Bayart

name: Service d'obstétrique Hôpital Bretonneau CHU Tours Tours France

family: Potin

full_name: Jérôme Potin

given: Jérôme

family: Rose

full_name: Johan Rose

given: Johan

family: Macchi

full_name: Laurent Macchi

family: Couturaud

full_name: Francis Couturaud

given: Francis

family: Lacut

full_name: Karine Lacut

given: Karine

name: Centre de traitement des maladies hémorragiques Hémostase cliniqueService d'hématologie clinique, CHU Brest Brest France

family: Pan‐Petesch

full_name: Brigitte Pan‐Petesch

given: Brigitte

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Haemophilia

oa_host_type: repository

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

host_type: repository

license_normalized: no license

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

repository_normalized: HAL

version: submittedVersion

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

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: University Hospital, Brest

location_facility:
Ch Le Mans
CHU de Nantes
CHU d'Angers
CHU de TOURS
CHU de Poitiers
CHRU de Brest
CHU de Rennes

status_simplified: Completed


title: Ventilation's Parameters Applied in Emergency Medicine. Observational Study

acronym: PARAVENT

summary:
To prospectively assess the mechanical ventilation management when its provided by Emergency Physicians in French Hospital, and to assess complications and outcome of these patients.

The study could be measure the proportion of patients developing an Acute Respiratory Failure Distress after a take care of by French Emergency Departments.

lead_sponsor: Poitiers University Hospital

location_facility:
Paul Fievet
CHU de Bordeaux
Pierre-Arnaud Fort
Marjanovic Nicolas
CH de Niort
Thomas Lenormand
Pierre-Marie Noël


title: Dependence on Analgesics in Chronic Non-cancer Pain: Comparison of the Perceptions of the Algologist Physician and the Perception of the Patient.

acronym: DISCORDANCE

summary: The identification of an addiction to opioid analgesics has become strong recommendation for the purpose of improving the clinical management of the patients. However, the success of the patient's clinical management, in terms of analgesia and treatment of drug dependence, rests on the acceptance of this management by the patient himself. The main objective of this study is to evaluate the factors associated to the discrepancy between the assessment of dependence on analgesic drugs by the algologist and the perception that the patient with non-cancer chronic pain has of this dependence.

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital Bordeaux
University HospitalToulouse
University Hospital Limoges
University Hospital Montpellier
University Hospital Clermont-Ferrand
University Hospital Nice
University Hospital Marseille

intervention_type: Behavioral


title: Platelet Transfusion Efficacy in Critically Ill Patients

acronym: RE-CCIP

summary:
Between 10 and 15% of critically ill patients require platelet transfusion within their intensive care unit (ICU).

Platelets (PLT) are given to prevent bleeding in thrombocytopenic patients or to treat bleeding as part of massive transfusion or in bleeding thrombocytopenic patients.

International and local guidelines (American Association of Blood Banks-AABB) are mainly based on experts' opinion. The efficacy of PLT transfusion in the ICU setting remains poorly studied and unknown and the administration of PLT may be associated with adverse effects including an increased risk of hospital acquired infection. Finally, the short PLT shelve-life may be responsible for inventory issues. Altogether, this makes very important to improve the evidence that support PLT transfusion in ICU patients.

This is a multicentre prospective observational study that aims to first determine PLT transfusion efficacy and to identify the parameters associated with transfusion efficacy and to analyse the compliance with international (and local) guidelines of PLT transfusion in ICU patients.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

location_facility:
Chba Site de Vannes
CH des Pays de Morlaix
CHU de Nantes
CHU d'Angers
CHU de Tours
CHRU de Brest
CHU de Rennes


study_start_date_type: Anticipated

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

title: Phase II Randomized Study Measuring the Interest of Pursuing or Not the CT for Non-progressive Patients With Metastatic Esophageal Squamous-cell Cancer After 6 Weeks of LV5FU2-paclitaxel Given After a 1st Line Fluoropyrimidine/Pt Salt CT

summary:
Phase II study, randomized, open-label, multicentric, willing to establish the benefit of pursuing chemotherapy beyond 6 weeks for non progressive patients. The study will proceed in two successive phases :

non randomized phase in which all patients will undergo chemotherapy
second phase in which only non progressive patients are going to be randomized ("discontinuation design"). Patients that will show progression in their disease during the first 6 weeks will be released of the study


title: Analysis of Volatile Organic Compounds in Exhaled Air as a Diagnostic Tool for Thoracic Cancers

acronym: CATOCOV

summary: Determination of volatile organic compounds to discriminate patients with lung cancer from healthy smokers and non-smokers healthy subjects.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Lille

location_facility: Institut Pasteur - Centre de Prévention et d'Education à la Santé (CPES)

intervention_type: Device


title: Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy

acronym: POPB-TOX

summary:
In children population with obstetrical brachial plexus palsy (OBPP), shoulder musculoskeletal deformity is the main cause of morbidity, with a loss of range of shoulder motion, pain and a reduction in social participation. Some uncontrolled studies shows that early injections of botulinum toxin (BTI) in the internal shoulder rotator muscles (which cause the deformity) are one of the most promising treatment for the prevention of bony deformity.

The main objective of this study will be the evaluation of the effectiveness of BTI in the internal shoulder rotator muscles at the age of 12 months in preventing an increase in posterior subluxation of the glenohumeral joint in babies with OBPP (evaluated at the ages of 11 months and 18 months), compared to the Sham group.

ReferenceCitation: Pons C, Eddi D, Le Gal G, Garetier M, Ben Salem D, Houx L, Fitoussi F, Quintero N, Brochard S; POPB-TOX Group. Effectiveness and safety of early intramuscular botulinum toxin injections to prevent shoulder deformity in babies with brachial plexus birth injury (POPB-TOX), a randomised controlled trial: study protocol. BMJ Open. 2019 Sep 30;9(9):e032901. doi: 10.1136/bmjopen-2019-032901.

family: Pons

full_name: Christelle Pons

family: Eddi

full_name: Dauphou Eddi

given: Dauphou

family: Le Gal

full_name: Gregoire Le Gal

given: Gregoire

family: Garetier

full_name: Marc Garetier

family: Ben Salem

full_name: Douraied Ben Salem

given: Douraied

family: Houx

full_name: Laetitia Houx

given: Laetitia

family: Fitoussi

full_name: Franck Fitoussi

given: Franck

family: Quintero

full_name: Nathaly Quintero

given: Nathaly

family: Brochard

full_name: Sylvain Brochard

given: Sylvain

currency_apc_doaj: GBP

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

version: publishedVersion

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

location_facility: ESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise)

location_facility: Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant


title: Comparison of Two Strategies for Blood Pressure Control in the Setting of Acute Ischemic Stroke to Reduce Cerebral Hemorrhage After Thrombectomy: Systolic Blood Pressure Target of Less Than 130 mmHg vs Less Than 185 mmHg, for 24 Hours Following Reperfusion, in Patients With Cerebral Infarction Due to Occlusion of the Anterior Circulation

acronym: BP-TARGET

summary: A randomized, multicenter study comparing two strategies: 1 / standard management of systolic blood pressure according to international recommendations (systolic blood pressure <185 mm Hg) versus 2 / intensive blood pressure management Systolic with a target <130 mm Hg.

ReferenceCitation: Mazighi M, Richard S, Lapergue B, Sibon I, Gory B, Berge J, Consoli A, Labreuche J, Olivot JM, Broderick J, Duhamel A, Touze E, Qureshi AI, Yavchitz A, Escalard S, Desilles JP, Redjem H, Smajda S, Fahed R, Hébert S, Maïer B, Delvoye F, Boursin P, Maacha MB, Obadia M, Sabben C, Blanc R, Savatovsky J, Piotin M; BP-TARGET investigators. Safety and efficacy of intensive blood pressure lowering after successful endovascular therapy in acute ischaemic stroke (BP-TARGET): a multicentre, open-label, randomised controlled trial. Lancet Neurol. 2021 Apr;20(4):265-274. doi: 10.1016/S1474-4422(20)30483-X. Epub 2021 Feb 26.

family: Mazighi

full_name: Mikael Mazighi

given: Mikael

family: Richard

full_name: Sebastien Richard

given: Sebastien

family: Lapergue

full_name: Bertrand Lapergue

given: Bertrand

family: Sibon

full_name: Igor Sibon

given: Igor

family: Gory

full_name: Benjamin Gory

given: Benjamin

family: Berge

full_name: Jerome Berge

given: Jerome

family: Consoli

full_name: Arturo Consoli

given: Arturo

family: Labreuche

full_name: Julien Labreuche

given: Julien

family: Olivot

full_name: Jean-Marc Olivot

given: Jean-Marc

family: Broderick

full_name: Joseph Broderick

given: Joseph

family: Duhamel

full_name: Alain Duhamel

given: Alain

family: Touze

full_name: Emmanuel Touze

given: Emmanuel

family: Qureshi

full_name: Adnan I Qureshi

given: Adnan I

family: Yavchitz

full_name: Amélie Yavchitz

given: Amélie

family: Escalard

full_name: Simon Escalard

given: Simon

family: Desilles

full_name: Jean-Philippe Desilles

given: Jean-Philippe

family: Redjem

full_name: Hocine Redjem

given: Hocine

family: Smajda

full_name: Stanislas Smajda

given: Stanislas

family: Fahed

full_name: Robert Fahed

given: Robert

family: Hébert

full_name: Solène Hébert

given: Solène

family: Maïer

full_name: Benjamin Maïer

family: Delvoye

full_name: François Delvoye

given: François

family: Boursin

full_name: Perrine Boursin

given: Perrine

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Hôpital neurologique Pierre Wertheimer, Hospices Civils de Lyon

location_facility: Centre Hospitalier Régional Universitaire

location_facility: Fondation Ophtalmologique A de Rothschild


title: Evaluation of the Impact of a Wearable Noninvasive Positive Pressure Ventilation Device on Physical Activity and Quality of Life in Patients With COPD

acronym: VITABREATH

summary: The objective is to assess the impact of a wearable Noninvasive Positive Pressure Ventilation, on physical activity and quality of life in patients with severe COPD, complaining of dyspnea.

primary_purpose: Device Feasibility

ipd_sharing: Undecided

lead_sponsor: Icadom

location_facility: Dr Christian PAILLARGUELO Pneumology Office


title: Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing

summary: A randomized clinical trial to investigate the use of the temporary Diaphragm Pacing Therapy System (DPTS) to rehabilitate the diaphragm in mechanically ventilated patients who have failed at least two weaning attempts. The goal is to strengthen and rehabilitate the diaphragm to liberate the patient more quickly from mechanical ventilation.

ReferenceCitation: Evans D, Shure D, Clark L, Criner GJ, Dres M, de Abreu MG, Laghi F, McDonagh D, Petrof B, Nelson T, Similowski T. Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation: study protocol for a randomized trial. Trials. 2019 Jan 17;20(1):60. doi: 10.1186/s13063-018-3171-9.

family: Evans

full_name: Douglas Evans

given: Douglas

family: Shure

full_name: Deborah Shure

given: Deborah

family: Clark

full_name: Linda Clark

given: Linda

family: Criner

full_name: Gerard J. Criner

given: Gerard J.

family: Dres

full_name: Martin Dres

given: Martin

family: de Abreu

full_name: Marcelo Gama de Abreu

given: Marcelo Gama

family: Laghi

full_name: Franco Laghi

given: Franco

family: McDonagh

full_name: David McDonagh

given: David

family: Petrof

full_name: Basil Petrof

given: Basil

family: Nelson

full_name: Teresa Nelson

given: Teresa

family: Similowski

full_name: Thomas Similowski

given: Thomas

journal_name: Trials

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing_description: Only investigators participating in this clinical trial will be able to see final de-identified participant data at the completion of the study and it will be available through the clinical research organization (CRO).

lead_sponsor: Lungpacer Medical Inc.

location_country: Germany France

location_facility: Heart and Diabetes Center Bad Oeynhausen

location_facility: Charite Universitatsmedizin Berlin - Mitte campus

location_facility: Centre Hospitalier Universitaire de Nice (CHU Nice)

location_facility: Asklepios Kliniken Hamburg GmbH - Asklepios Klinikum Harburg

location_facility: Wissenschaftliches Institut Bethanien fur Pneumologie e.V.


title: Phase 3 Study Randomized Against Placebo, Evaluating the Efficacy of Auriculotherapy in Patients With Musculoskeletal Pain by Aromatase Inhibitors in Adjuvant Treatment of Breast Cancer (TRIPLE-A)

acronym: TRIPLE-A

summary: Auriculotherapy is a complementary medicine, with few side effects, without contraindication, inexpensive and not very restrictive.Its efficacy has been found in several tests especially for the treatment of intraoperative pain. It remains more controversial in other indications. Evaluation of the value of auriculotherapy is often difficult because of the methodological limitations of the trials conducted. In the daily practice, the auriculotherapy is proposed to improve the articular pains of patients treated by AA. This Phase III study aims at validate this approach.

primary_purpose: Supportive Care

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre François Baclesse
IGR
Centre Oscar Lambret
Hôpital Cognac-Jay - Forcilles
Hôpital Privé Paul d'Egine
CHU Grenoble
Groupe Hospitalier Paris St Joseph


title: Study of the Frequency of Hemorrhages Associated With the Functional Anomalies of Willebrand Factor in Emergency Patients of a Veino Arterial or Veinous ECMO

acronym: WITECMO-H

summary: ECMO has improved the outcome of heart or respiratory failure and carcinogenic shock and are increasingly used. However bleeding complications occurring in up to 50% of patients are poorly understood and worsen the overall results. The aim is to investigate the occurence of bleeding and its frequency according to the type of ECMO either veno-arterial or veno-venous. The investigators also want to assess the relation of bleeding with von Willebrand Factor defects.

location_facility:
Hôpital Cardiologie, CHU
CH ARRAS
CH Dunkerque
CH DOUAI
Ch Valenciennes
CH Boulogne
Ch Tourcoing


title: Quality Control of Pancreatic Islet Intended to Islet Graft

acronym: ISLET CHIP

summary: Islet quality control after pancreatic islets isolation process is insufficient. The Islet Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of islet graft based on measurement of islet membrane electric potential.

ReferenceType: background

ReferenceCitation: Kusnik-Joinville O, Weill A, Salanave B, Ricordeau P, Allemand H. Prevalence and treatment of diabetes in France: trends between 2000 and 2005. Diabetes Metab. 2008 Jun;34(3):266-72. doi: 10.1016/j.diabet.2008.01.005. Epub 2008 Jun 3.

ReferenceCitation: Gruessner RW, Gruessner AC. The current state of pancreas transplantation. Nat Rev Endocrinol. 2013 Sep;9(9):555-62. doi: 10.1038/nrendo.2013.138. Epub 2013 Jul 30. Review.

ReferenceCitation: Ricordi C, Lacy PE, Finke EH, Olack BJ, Scharp DW. Automated method for isolation of human pancreatic islets. Diabetes. 1988 Apr;37(4):413-20.

ReferenceCitation: Lablanche S, Borot S, Wojtusciszyn A, Bayle F, Tétaz R, Badet L, Thivolet C, Morelon E, Frimat L, Penfornis A, Kessler L, Brault C, Colin C, Tauveron I, Bosco D, Berney T, Benhamou PY; GRAGIL Network. Five-Year Metabolic, Functional, and Safety Results of Patients With Type 1 Diabetes Transplanted With Allogenic Islets Within the Swiss-French GRAGIL Network. Diabetes Care. 2015 Sep;38(9):1714-22. doi: 10.2337/dc15-0094. Epub 2015 Jun 11.

family: Lablanche

full_name: Sandrine Lablanche

given: Sandrine

family: Borot

full_name: Sophie Borot

given: Sophie

family: Wojtusciszyn

full_name: Anne Wojtusciszyn

given: Anne

family: Bayle

full_name: Francois Bayle

given: Francois

family: Tétaz

full_name: Rachel Tétaz

given: Rachel

family: Badet

full_name: Lionel Badet

given: Lionel

family: Thivolet

full_name: Charles Thivolet

given: Charles

family: Morelon

full_name: Emmanuel Morelon

given: Emmanuel

family: Frimat

full_name: Luc Frimat

given: Luc

family: Penfornis

full_name: Alfred Penfornis

given: Alfred

family: Kessler

full_name: Laurence Kessler

given: Laurence

family: Brault

full_name: Coralie Brault

given: Coralie

family: Colin

full_name: Cyrille Colin

given: Cyrille

family: Tauveron

full_name: Igor Tauveron

given: Igor

family: Bosco

full_name: Domenico Bosco

given: Domenico

family: Berney

full_name: Thierry Berney

given: Thierry

family: Benhamou

full_name: Pierre-Yves Benhamou

given: Pierre-Yves

journal_name: Diabetes Care

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

ReferenceCitation: Lebreton F, Pirog A, Belouah I, Bosco D, Berney T, Meda P, Bornat Y, Catargi B, Renaud S, Raoux M, Lang J. Slow potentials encode intercellular coupling and insulin demand in pancreatic beta cells. Diabetologia. 2015 Jun;58(6):1291-9. doi: 10.1007/s00125-015-3558-z. Epub 2015 Mar 19.

ReferenceCitation: Renaud S, Catargi B, Lang J. Biosensors in diabetes : how to get the most out of evolution and transpose it into a signal. IEEE Pulse. 2014 May-Jun;5(3):30-4. doi: 10.1109/MPUL.2014.2309577. Review.

lead_sponsor: University Hospital, Grenoble

location_country: France Switzerland

location_facility:
Montpellier University Hospital
Lyon University Hospital
University hospital of Strasbourg
Besançon University Hospital
Grenoble University Hospital
Geneva University Hospital
Clermont Ferrand University hospital
Nancy University hospital


acronym: TOBRAMUC

location_facility: CRCM adulte - CHRU de Lille Hôpital Calmette

location_facility: CRCM mixte - CHU de Caen Hôpital Côte de Nacre

location_facility: CRCM mixte - CHU de Rouen Hôpital Charles Nicolle

location_facility: CRCM pédiatrique - CHU d'Amiens Hôpital Nord

location_facility: CRCM pédiatrique - CHRU de Lille Hôpital Jeanne de Flandres

title: Evaluation of an Antibiotic Treatment With 14 Days of Intravenous Tobramycin Versus the Same Antibiotic Associated With 5 Days of Intravenous Tobramycin Followed by Tobramycin Aerosol for 9 Days in Cystic Fibrosis.

summary: The aim of this study is to investigate the efficacy of antibiotic therapy with any antibiotic (IV) and IV (Nebcin®) tobramycin for 5 days followed by Solution for nebuliser inhalation (Tobi®) for 9 days and antibiotic cures using 14 days of tobramycin IV. In the case of positive results, the reduction of the duration of IV treatment of tobramycin from 14 days to 5 days would limit the risk of toxicity.


title: Does the Strengthening of the Pancreas in Distal Pancreatectomy Using Endo GIA Reload Reinforced Reduce the Occurrence of Pancreatic Fistula? Multicenter Randomized Prospective Open Study

acronym: REPLAY

summary: Despite an improvement regarding morbidity and mortality since 30 years, especially in expert centers, pancreatic surgery remains currently associated to a significant postoperative morbidity reaching more than 60%. Regarding distal pancreatectomy (DP), the main complication following surgery is the occurrence of postoperative pancreatic fistula (PF) which may be able to lead an increased risk of bleeding, gastroparesis and finally a longer hospital stays. The main risk factors associated to the occurrence of pancreatic fistula are represented by the texture of the pancreatic parenchyma (soft pancreas) and the caliber of the main pancreatic duct (<3mm). Looking for new means of reducing the occurrence of pancreatic fistula is a priority in pancreatic surgery and a genuine public health issue. Currently, no formal recommendations concerning the optimal technical for closure of the distal stump in DP are available. In fact, manual closing by elective suturing or stapling of the main pancreatic duct give similar results. The use of a reinforcing stapling potentially represents a simple way to decrease the occurrence of pancreatic fistula and requires evaluation by a prospective randomized study.

status: Active, not recruiting

primary_purpose: Other

lead_sponsor: Rennes University Hospital

location_facility: Service de chirurgie générale, digestive et de la transplantation hépatique

location_facility: AP-HM - Institut Paoli Calmettes_ service de chirurgie oncologique digestive

location_facility: Centre Hospitalier Universitaire Rennes Pontchaillou

location_facility: Service de chirurgie digestive et endocrienne

location_facility: Service de chirurgie Hépato-pancréato-biliaire

location_facility: Unité d'hospitalisation Chirurgie hépatique, biliaire et pancréatique


title: Randomized Study Assessing Two Strategies of First Line: a Strategy With Intraperitoneal Chemotherapy and a Strategy With Total Intravenous Strategy, in Patients With Epithelial Advanced Ovarian Cancer

acronym: CHIMOVIP

summary: CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian advanced cancer.

lead_sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon


title: A Controlled, Prospective, Non-Inferiority, Parallel-Group, Randomised, Interventional, Open, Blinded Outcome Assessment (PROBE-Design), Multi-centre Trial, Comparing Efficacy and Safety of Isolation of the PVs With a Cryoballoon Catheter vs a Radiofrequency Ablation With a ThermoCool Catheter in Patients With PAF

summary: Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation.

ReferenceCitation: Fürnkranz A, Brugada J, Albenque JP, Tondo C, Bestehorn K, Wegscheider K, Ouyang F, Kuck KH. Rationale and Design of FIRE AND ICE: A multicenter randomized trial comparing efficacy and safety of pulmonary vein isolation using a cryoballoon versus radiofrequency ablation with 3D-reconstruction. J Cardiovasc Electrophysiol. 2014 Dec;25(12):1314-20. doi: 10.1111/jce.12529. Epub 2014 Nov 12.

ReferenceType: result

ReferenceCitation: Kuck KH, Brugada J, Fürnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.

family: Kuck

full_name: Karl-Heinz Kuck

given: Karl-Heinz

family: Brugada

full_name: Josep Brugada

given: Josep

family: Fürnkranz

full_name: Alexander Fürnkranz

given: Alexander

family: Metzner

full_name: Andreas Metzner

given: Andreas

family: Ouyang

full_name: Feifan Ouyang

given: Feifan

family: Chun

full_name: K.R. Julian Chun

given: K.R. Julian

family: Elvan

full_name: Arif Elvan

given: Arif

family: Arentz

full_name: Thomas Arentz

given: Thomas

family: Bestehorn

full_name: Kurt Bestehorn

given: Kurt

family: Pocock

full_name: Stuart J. Pocock

given: Stuart J.

family: Albenque

full_name: Jean-Paul Albenque

given: Jean-Paul

family: Tondo

full_name: Claudio Tondo

given: Claudio

journal_name: New England Journal of Medicine

oa_colors: green other

evidence: open (via free article)

version: acceptedVersion

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: Kuck KH, Brugada J, Fürnkranz A, Chun KRJ, Metzner A, Ouyang F, Schlüter M, Elvan A, Braegelmann KM, Kueffer FJ, Arentz T, Albenque JP, Kühne M, Sticherling C, Tondo C; FIRE AND ICE Investigators. Impact of Female Sex on Clinical Outcomes in the FIRE AND ICE Trial of Catheter Ablation for Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2018 May;11(5):e006204. doi: 10.1161/CIRCEP.118.006204.

name: Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., A.M., F.O., M.S.).

name: Hospital Clinic, University of Barcelona, Spain (J.B.).

name: Cardioangiologisches Centrum Bethanien, Frankfurt, Germany (A.F., K.R.J.C.).

name: Dr Fürnkranz’s current affiliation: Department of Cardiology, Pneumology, and Angiology, University Hospital Düsseldorf, Germany.

name: Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands (A.E.).

name: Medtronic, Inc, Minneapolis, MN (K.M.B., F.J.K.).

name: Klinik für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg - Bad Krozingen, Bad Krozingen, Germany (T.A.).

name: Cardiologie Générale, Clinique Pasteur, Toulouse, France (J.-P.A.).

name: Abteilung für Kardiologie, Universitätsspital Basel, Switzerland (M.K., C.S.).

name: Monzino Sport Center Arrhythmia Unit, Centro Cardiologico Monzino, University of Milan, Italy (C.T.).

name: on behalf of the FIRE AND ICE Investigators*

journal_name: Circulation: Arrhythmia and Electrophysiology

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Chun KRJ, Brugada J, Elvan A, Gellér L, Busch M, Barrera A, Schilling RJ, Reynolds MR, Hokanson RB, Holbrook R, Brown B, Schlüter M, Kuck KH; FIRE AND ICE Investigators. The Impact of Cryoballoon Versus Radiofrequency Ablation for Paroxysmal Atrial Fibrillation on Healthcare Utilization and Costs: An Economic Analysis From the FIRE AND ICE Trial. J Am Heart Assoc. 2017 Jul 27;6(8). pii: e006043. doi: 10.1161/JAHA.117.006043. Erratum in: J Am Heart Assoc. 2017 Sep 15;6(9):.

name: Semmelweis University, Budapest, Hungary

name: University Hospital, Greifswald, Germany

name: Institute of Cardiotechnology, Benalmádena, Spain

name: Cardiology Research Department, Barts Heart Centre, St Bartholomew's Hospital, Barts Health NHS Trust, London, United Kingdom

name: Department of Cardiovascular Medicine, Lahey Hospital and Medical Center, Harvard Clinical Research Institute, Boston, MA

name: Medtronic International Trading Sarl, Tolochenaz, Switzerland

journal_name: Journal of the American Heart Association

repository_institution: Semmelweis University - Semmelweis University Repository

ReferenceCitation: Kuck KH, Fürnkranz A, Chun KR, Metzner A, Ouyang F, Schlüter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kühne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016 Oct 7;37(38):2858-2865. Epub 2016 Jul 5.

ReferenceCitation: Luik A, Radzewitz A, Kieser M, Walter M, Bramlage P, Hörmann P, Schmidt K, Horn N, Brinkmeier-Theofanopoulou M, Kunzmann K, Riexinger T, Schymik G, Merkel M, Schmitt C. Cryoballoon Versus Open Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: The Prospective, Randomized, Controlled, Noninferiority FreezeAF Study. Circulation. 2015 Oct 6;132(14):1311-9. doi: 10.1161/CIRCULATIONAHA.115.016871. Epub 2015 Aug 17.

name: From Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).

location_country: Italy Switzerland Netherlands France Czechia Hungary Spain Germany

location_facility: CHU Lyon, Départment de Rythmologie, Hospital Cardiologique Pradel

location_facility: Klinik für Kardiologie II mit interventioneller Elektrophysiologie

location_facility: Isala Klinieken loc. Weezenlanden Diagram Clinical Resarch

location_facility: Universitätsspital Basel, Elektrophysiologie/ Kardiologie

location_facility: Semmelweis University of Medicine, Kardiovaskuläres Zentrum

location_facility: Arrhythmia Unit Hospital Clinico San Carlos

location_facility: Cardiac Arrhythmia Research Centre Department of Cardiovascular Medicine Centro Cardiologico Monzino University of Milan

location_facility: Cardioangiologisches Centrum Bethanien - CCB

location_facility: Hospital Henri Mondor CHU, Service de Cardiologie

location_facility: Hospital Universitario Virgen de la Victoria, Department of Cardiology, Campus Teatinos sn

location_facility: La Clinique Pasteur, 45 Avenue de Lombez

location_facility: Hospital Clinico Universtitario, Cardiology Department Arrhythmia Unit


ReferenceCitation: Santagostino E, Negrier C, Klamroth R, Tiede A, Pabinger-Fasching I, Voigt C, Jacobs I, Morfini M. Safety and pharmacokinetics of a novel recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in hemophilia B patients. Blood. 2012 Sep 20;120(12):2405-11. Epub 2012 Aug 2.

intervention_type: Biological

lead_sponsor: CSL Behring

location_country: Italy Austria France Israel Spain Germany

location_facility:
Study site
Study Site

title: An Open-label, Multicenter, Dose-Escalation Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B

summary: The primary objective of the study is to assess the safety of IV administration of rIX-FP. Safety will be evaluated by adverse events and laboratory changes over time. The secondary objective of the study is to evaluate the pharmacokinetics parameters, following a single intravenous dose of rIX-FP.


title: Influence de l'ORientation de la réponse LYmphocytaire Sur la Survenue de Complications athéromateuses après Transplantation rénale (étude ORLY-EST 2)

acronym: ORLY-Est

summary:
The incidence of atherosclerotic complications is increased after kidney transplantation. Traditional risk factors do not fully explain this increased risk. Atherosclerosis is an inflammatory disease in which all players in the immune response are involved. The impact of these immune responses is not well known in immunocompromised patients, particularly among organ transplant. Nevertheless, the work of our group suggest that innate and acquired responses through different mechanisms influencing the evolution of atheromatous disease after transplantation.

The investigators therefore propose to study the impact of the expansion of regulatory T cells on the risk of atherosclerotic complications after transplantation.

Since November 2008, the investigators began a multicenter, prospective study whose purpose is to study in detail the immunological mechanisms of atherosclerosis after transplantation via immunomonitoring cohort of renal transplant patients in the Grand East Interregion. It was planned to include 500 patients and to date a little more than half have been included. After completion of the blood test, the tubes are routed over the Biomonitoring Platform (CIC-BT 506 Besançon) and the samples are stored in CRB Dijon.

The atherosclerotic events are recorded prospectively. The investigators hope to implement as part of ORLY IS, a second study to determine the impact of an expansion of regulatory T cells on the risk of atherosclerotic events.

Our hypothesis is that a cell rate regulatory T below the median results in an increase of 5% of atherosclerotic complications.

ReferenceCitation: Ducloux D, Courivaud C, Bamoulid J, Crepin T, Gaiffe E, Laheurte C, Vauchy C, Rebibou JM, Saas P, Borot S. Immune phenotype predicts new onset diabetes after kidney transplantation. Hum Immunol. 2019 Nov;80(11):937-942. doi: 10.1016/j.humimm.2019.08.006. Epub 2019 Sep 10.

family: Ducloux

full_name: Didier Ducloux

given: Didier

family: Courivaud

full_name: Cécile Courivaud

given: Cécile

family: Bamoulid

full_name: Jamal Bamoulid

given: Jamal

family: Crepin

full_name: Thomas Crepin

family: Gaiffe

full_name: Emilie Gaiffe

given: Emilie

family: Laheurte

full_name: Caroline Laheurte

given: Caroline

family: Vauchy

full_name: Charline Vauchy

given: Charline

family: Rebibou

full_name: Jean-Michel Rebibou

given: Jean-Michel

family: Saas

full_name: Philippe Saas

given: Philippe

family: Borot

full_name: Sophie Borot

given: Sophie

journal_name: Human Immunology

evidence: open (author manuscript)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Ducloux D, Legendre M, Bamoulid J, Rebibou JM, Saas P, Courivaud C, Crepin T. ESRD-associated immune phenotype depends on dialysis modality and iron status: clinical implications. Immun Ageing. 2018 Jul 17;15:16. doi: 10.1186/s12979-018-0121-z. eCollection 2018.

family: Legendre

full_name: Mathieu Legendre

given: Mathieu

journal_name: Immunity & Ageing

ipd_sharing_description: Identified individual participant data for all outcome measures will be made available within 6 monts of study completion

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: CHU Clermont-Ferrand, 58 rue Montalembert, 63003 Clermont-Ferrand

location_facility: Hôpital Civil- 1, place de l'hôpital BP426 ; 67091 Strasbourg Cedex

location_facility: CHU Reims, 45 rue Cognacq-Jay 51092 Reims Cedex

location_facility: Hôpital du Kremlin Bicêtre 78, rue du Général Leclerc, 94275 Le Kremlin-Bicêtre Cedex

location_facility: CHU Dijon, Hôpital du Bocage, 2 Bd du Maréchal de Lattre de Tassigny, 21079 Dijon cedex


title: Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient: Multicentre Randomized Trial

acronym: RENOMAP

summary: Comparison of two techniques of renal pre-transplant infusion on the evolution of renal function in the recipient: multicentre randomized trial

lead_sponsor: University Hospital, Tours

location_facility: Chirurgien-Chirurgie de la transplantation et d'Urologie, Pavillon V, Hôpital Edouard HERRIOT

location_facility: Coordination Hospitalière de PMO-Anestésiste -réanimateur, CHU-Bordeaux -GROUPE HOSPITALIER PELLEGRIN DAR I

location_facility: Coordination des prélèvements d'organes et de Tissus,CHU-NANTES

location_facility: Coordination des prélèvements d'organes et de Tissus Pôle Anesthésie-Réanimations,University Hospital

location_facility: Coordination des prélèvements d'organes et de Tissus- CHU-Limoges -CHU- DUPUYTREN

location_facility: Coordination Hospitalière de PMO , Pôle USSAR-Anestéthésie -Réa CHU-ANGERS


title: Endoplasmic Reticulum Stress and Resistance to Treatments in Ph-negative Myeloproliferative Neoplasms

acronym: PhiNESS

summary: The aim of this study is to evaluate the endoplasmic reticulum stress markers as predictive for response to hydroxyurea in polycythemia vera (PV) and essential thrombocythemia (ET).

lead_sponsor: University Hospital, Bordeaux

location_facility:
Chu de Bordeaux
Chu Angers
Ch de Libourne
Ch de La Cöte Basque
Crlcc Bergonie
Chu de Brest
Ch de Dax


ReferenceCitation: Marret G, Isambert N, Rezai K, Gal J, Saada-Bouzid E, Rolland F, Chausson M, Borcoman E, Alt M, Klijanienko J, Vansteene D, Guigay J, Kamal M, Bièche I, Le Tourneau C; UNICANCER Head, Neck Group. Phase I trial of copanlisib, a selective PI3K inhibitor, in combination with cetuximab in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Invest New Drugs. 2021 Dec;39(6):1641-1648. doi: 10.1007/s10637-021-01152-z. Epub 2021 Jul 28.

family: Marret

full_name: Grégoire Marret

given: Grégoire

family: Isambert

full_name: Nicolas Isambert

given: Nicolas

family: Rezai

full_name: Keyvan Rezai

given: Keyvan

family: Gal

full_name: Jocelyn Gal

given: Jocelyn

family: Saada-Bouzid

full_name: Esma Saada-Bouzid

given: Esma

family: Rolland

full_name: Frédéric Rolland

given: Frédéric

family: Chausson

full_name: Maggy Chausson

given: Maggy

family: Borcoman

full_name: Edith Borcoman

given: Edith

family: Alt

full_name: Marie Alt

given: Marie

family: Klijanienko

full_name: Jerzy Klijanienko

given: Jerzy

family: Vansteene

full_name: Damien Vansteene

given: Damien

family: Guigay

full_name: Joël Guigay

given: Joël

family: Kamal

full_name: Maud Kamal

given: Maud

family: Bièche

full_name: Ivan Bièche

given: Ivan

family: Le Tourneau

full_name: Christophe Le Tourneau

given: Christophe

journal_name: Investigational New Drugs

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

repository_institution: Research Square - Research Square

repository_normalized: Research Square

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

lead_sponsor: UNICANCER

location_facility:
Centre Antoine Lacassagne
Centre Léon Bérard
Institut de Cancérologie de l'Ouest
Centre Oscar Lambret
Centre Georges François Leclerc
Institut de Cancérologie de Lorraine
Institut Curie

title: Phase ib/II Trial of Copanlisib, a Selective PI3K Inhibitor, in Combination With Cetuximab in Patients With Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Harboring a PI3KCA Mutation/Amplification and/or a PTEN Loss.

summary:
The study consists of two distinct and sequential parts:

A Phase Ib aimed at determining the MTD (Maximum Tolerated Dose) of the combination (copanlisib/cetuximab) and the RP2D
A Phase II aimed at evaluating the efficacy of the combination at the RP2D (Recommended Phase 2 Dose)

All patients will be treated with the Copanlisib, a selective PI3KCA inhibitor, in association with Cetuximab.


title: Evaluation of the Efficacy and Safety of Use of an Innovative Medical Device for Improving Oral Accessibility in People With Disabilities, Presenting Behavioral Disorders: The Oral Accessibility Spatula (Spatule SAB)

acronym: SAB

summary: The purpose of this study is to evaluate the efficiency and the safe use of a new medical device to improve the oral accessibility of disabled people during the oral-dental examination.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

location_facility:
Clinique Saint Francois
CHR METZ THIONVILLE- Bel-Air Hospital
CHRU Nancy
CHR Metz-Thionville- Mercy Hospital
CHRU Strasbourg
CHU Dijon
Centre Hospitalier Emile Durkheim


title: Phase 2 Gene Therapy Trial of Locally Advanced Pancreatic Adenocarcinoma Using Intratumoral Injection of CYL-02 in Combination With Gemcitabine

summary:
Pancreatic ductal adenocarcinoma (PDAC) is the fifth leading cause of cancer-related death in Western countries, and its incidence has increased over the last 40 years. Curative surgery to manage PDAC is possible in only a fraction of patients; indeed, a vast majority (85%) of patients is diagnosed with locally advanced tumors and/or metastases because they lack specific symptoms and early markers for this disease. For these patients, palliative armamentarium consists of conventional chemotherapeutic agents such as Gemcitabine and, more recently, FOLFIRINOX, which offer marginal survival benefits. Consequently, the prognosis for PDAC is still very poor and there is great need for new treatments that can change this poor outcome. In this context, the investigators have devised, in the past few years, a highly innovative approach based on therapeutic gene transfer, which does not rely on a specific genetic and/or cellular background to inhibit PDAC tumor growth. the investigators found that SSTR2 and DCK::UMK gene transfer demonstrated complementary therapeutic effects to inhibit tumor progression and dissemination, and reduced tumor burden, respectively. On the basis of these promising preclinical data, the investigators conducted past three years the first clinical study of non-viral vector-mediated therapeutic gene delivery, guided by endoscopy (EUS), and combined with standard Gemcitabine therapy in patients with locally advanced and metastatic PDAC. The phase 1 demonstrated that the gene-therapy product CYL-02 is expressed in PDAC tumors (with long-lasting expression within tumor tissues), is distributed within the bloodstream in some extent, when combined with Gemcitabine it can inhibit primary-tumor progression and dissemination. Our results tend to demonstrate therapeutic efficacy, especially in patients with locally advanced tumors. Based on these encouraging results, the investigators propose that patients with locally advanced PDAC at the time of diagnosis may clinically benefit from this approach.

This phase II study is designed to compare the efficacy of intra-tumoral gene delivery of CYL-02 plus Gemcitabine treatment or Gemcitabine alone in patient with locally advanced PDAC.

location_facility:
Institut régional du Cancer
CHU de Marseille Hôpital Nord
APHP Hôpital Beaujon
Institut Paoli Calmettes
Rangueil Hospital
Institut Gustave Roussy
Hôpital privé Jean Mermoz


title: Vascular-Targeted Photodynamic Therapy Using WST 11 in Patients With Localized Prostate Cancer

summary:
The aim of this clinical study is to determine the optimal treatment conditions to achieve prostate cancer tumor ablation and to assess the effects of WST11 mediated VTP treatment in patients with localized prostate cancer.

The secondary objectives is to evaluate safety and quality of life ; to assess the pharmacokinetic parameters and to model the relationship between concentration and effects; and to assess the effects, the safety and quality of life of a second WST11 VTP treatment in patients with persistent or recurrent localized prostate cancer after a first VTP;

ReferenceCitation: Moore CM, Azzouzi AR, Barret E, Villers A, Muir GH, Barber NJ, Bott S, Trachtenberg J, Arumainayagam N, Gaillac B, Allen C, Schertz A, Emberton M. Determination of optimal drug dose and light dose index to achieve minimally invasive focal ablation of localised prostate cancer using WST11-vascular-targeted photodynamic (VTP) therapy. BJU Int. 2015 Dec;116(6):888-96. doi: 10.1111/bju.12816. Epub 2015 Apr 21.

name: Division of Surgery and Interventional Science; University College London; London UK

family: Moore

full_name: Caroline M. Moore

given: Caroline M.

family: Azzouzi

full_name: Abel-Rahmene Azzouzi

given: Abel-Rahmene

family: Barret

full_name: Eric Barret

given: Eric

name: Hôpital Claude Huriez; CHRU; Lille France

family: Villers

full_name: Arnauld Villers

given: Arnauld

family: Muir

full_name: Gordon H. Muir

given: Gordon H.

name: Frimley Park and Basingstoke Hospitals; Surrey UK

family: Barber

full_name: Neil J. Barber

given: Neil J.

family: Bott

full_name: Simon Bott

given: Simon

name: Princess Margaret Hospital; Toronto Canada

family: Trachtenberg

full_name: John Trachtenberg

given: John

family: Arumainayagam

full_name: Nimalan Arumainayagam

given: Nimalan

family: Gaillac

full_name: Bertrand Gaillac

given: Bertrand

family: Allen

full_name: Clare Allen

given: Clare

name: Plant Sciences; Weizmann Institute of Science; Rehovot Israel

family: Schertz

full_name: Avigdor Schertz

given: Avigdor

family: Emberton

full_name: Mark Emberton

given: Mark

journal_name: BJU International

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

ReferenceCitation: Azzouzi AR, Lebdai S, Benzaghou F, Stief C. Vascular-targeted photodynamic therapy with TOOKAD® Soluble in localized prostate cancer: standardization of the procedure. World J Urol. 2015 Jul;33(7):937-44. doi: 10.1007/s00345-015-1535-2. Epub 2015 Mar 19.

full_name: Abdel-Rahmene Azzouzi

given: Abdel-Rahmene

family: Lebdai

full_name: Souhil Lebdai

given: Souhil

family: Benzaghou

full_name: Fawzi Benzaghou

given: Fawzi

family: Stief

full_name: Christian Stief

given: Christian

journal_name: World Journal of Urology

oa_colors: green hybrid

evidence: open (via page says license)

ReferenceCitation: Azzouzi AR, Barret E, Bennet J, Moore C, Taneja S, Muir G, Villers A, Coleman J, Allen C, Scherz A, Emberton M. TOOKAD® Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of localized prostate cancer. World J Urol. 2015 Jul;33(7):945-53. doi: 10.1007/s00345-015-1505-8. Epub 2015 Feb 25.

ReferenceCitation: Lebdai S, Villers A, Barret E, Nedelcu C, Bigot P, Azzouzi AR. Feasibility, safety, and efficacy of salvage radical prostatectomy after Tookad® Soluble focal treatment for localized prostate cancer. World J Urol. 2015 Jul;33(7):965-71. doi: 10.1007/s00345-015-1493-8. Epub 2015 Jan 23.

ReferenceCitation: Colin P, Estevez JP, Betrouni N, Ouzzane A, Puech P, Leroy X, Biserte J, Villers A, Mordon S. [Photodynamic therapy and prostate cancer]. Prog Urol. 2011 Feb;21(2):85-92. doi: 10.1016/j.purol.2010.07.018. Epub 2010 Sep 17. Review. French.

title: Thérapie photodynamique et cancer de la prostate

ipd_sharing_description: The data are available in case report form for each patient

location_facility: University Health Network-Princess Margaret Hospital


title: Comparison of Basal Bolus Treatment With Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes Mellitus

summary: This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.

ReferenceCitation: Ligthelm RJ, Mouritzen U, Lynggaard H, Landin-Olsson M, Fox C, le Devehat C, Romero E, Liebl A. Biphasic insulin aspart given thrice daily is as efficacious as a basal-bolus insulin regimen with four daily injections: a randomised open-label parallel group four months comparison in patients with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Oct;114(9):511-9.

lead_sponsor: Novo Nordisk A/S

location_country:
Sweden
Hong Kong
Netherlands
Croatia
Malaysia
France
Poland
Romania
Singapore
Russian Federation
Spain
Germany
United Kingdom


title: Thrombin Generation Capacity of Patients With Severe Haemophilia Receiving Prophylaxis

acronym: HOPE

summary:
Haemophilic arthropathy is one of the major complications of severe haemophilia. In order to maintain plasma clotting factor activity levels above 1% and avoid spontaneous joint bleeds and other serious bleeding events, prophylactic factor replacement therapy is used. Because of the high cost and limited availability of clotting factor concentrates, dosing is a crucial issue for prophylaxis therapy. Several studies reported a better correlation between clinical bleeding tendency of patients with haemophilia and thrombin generation assay results compared to FVIII/FIX levels. However there is no specific data showing that thrombin generation may be a better indicator of the clinical efficacy of prophylaxis compared to the conventional FVIII measurement.

The main objective of this open, multicentre, prospective study is to compare trough thrombin generation capacity and FVIII levels in severe haemophilia patients and compare these two laboratory results with:

the number of spontaneous haemarthroses and other spontaneous serious bleeds occurred in the last 6 months
the number of additional FVIII units used in the last 6 months

This project requires no change in term of type of treatment : During the study, each patient will be treated by his usual clotting factor at the usual regimen (frequency and dosage).

The clinical outcome with the usual prophylaxis regimen will be correlated to TGA results

lead_sponsor: Hospices Civils de Lyon

location_facility: CHU Dijon Bourgogne Hôpital François Mitterrand

location_facility: Unité d'Hémostase Clinique Centre Régional de Traitement des Hémophiles Centre de Référence de Maladies Hémorragiques Hôpital Cardiologique Louis Pradel


title: A Phase I-II Study of NBTXR3 Activated by Sterostatic Body Radiation Therapy (SBRT) In the Treatment of Liver Cancers

summary: The purpose of this Phase I / II study is to evaluate the safety and preliminary efficacy of NBTXR3 nanoparticles given by intralesional (IL) or intraarterial (IA) injection and activated by Stereotactic Body Radiation Therapy in the treatment of liver cancers.

lead_sponsor: Nanobiotix

location_facility:
Centre Eugène Marquis
CHU La Croix Rousse
Institut de Cancérologie de Loraine
Centre René Gauducheau
CHU de NANCY
Institut Gustave Roussy
Hôpital Haut-Lévêque

intervention_type: Radiation


title: An Evaluation of a Doppler-Guided Uterine Artery Occlusion Device as Treatment for the Reduction of Fibroid-Associated Bleeding

summary: The primary objective of this study is to evaluate the safety and effectiveness of Doppler guided Uterine Artery Occlusion (D-UAO) as treatment for the reduction of fibroid-associated symptoms.

lead_sponsor: Ethicon, Inc.

location_country:
Switzerland
Netherlands
France
Norway
Denmark
Germany
United Kingdom

location_facility: Queen Elizabeth the Queen Mother Hospital

location_facility: Service de Gynecologie Obsterique, Hopital Antoine Beclere

location_facility: CHRU de Lille, Hopital Jeanne de Flandre

location_facility: Hull and East Yorkshire Women & Children Hospital


title: EXpanded CELL ENdocardiac Transplantation (EXCELLENT)

acronym: EXCELLENT

summary: A multicentric controlled phase I / IIb study evaluating the safety and the efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand® Automated Process, and injected in patients with an acute myocardial infarction and a LVEF remaining below 50% after reperfusion versus standard of care.

lead_sponsor: CellProthera

location_country:
United Kingdom
France

location_facility: CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel

location_facility: Leeds University & Leeds Teaching Hospitals NHS Trust

location_facility: BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way,

location_facility: Saint Bartholomew's Hospital W Smithfield,

location_facility: CHU BESANCON Hopital Jean Minjoz 3 Boulevard A.Fleming


title: Evaluation of the Implementation of a Clinical Pathway for Improving the Performance of Medical and Surgical Management of Hip Prosthesis Infections

acronym: OSCAR-PH

summary: The main objective is to determine the contribution of a clinical pathway to improve the effectiveness of medico-surgical management of hip prosthesis infections in terms of clinical cure. The hypothesis raised is that the implementation of a clinical pathway would improve the performance of the medical and surgical management of chronic infections of prosthetic hip.

location_facility: Groupe Hospitalier Mutualiste de Grenoble.


title: A Multicenter, Open, Phase II Study to Estimate the Activity and Safety of Caspofungin (CASP) in the First-Line Treatment of Probable and Proven Invasive Aspergillosis (IA) in Patients With Hematological Malignancies (HM) or Recipients of Autologous Haematopoietic Stem Cell Transplantation and Those With Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)

summary:
RATIONALE: Antifungals, such as caspofungin acetate, may be effective in treating fungal infections caused by chemotherapy or stem cell transplant.

PURPOSE: This phase II trial is studying how well caspofungin acetate works as first-line treatment for aspergillosis in patients with hematologic cancer or in patients who have undergone a stem cell transplant.

ReferenceCitation: Viscoli C, Herbrecht R, Akan H, Baila L, Sonet A, Gallamini A, Giagounidis A, Marchetti O, Martino R, Meert L, Paesmans M, Ameye L, Shivaprakash M, Ullmann AJ, Maertens J; Infectious Disease Group of the EORTC. An EORTC Phase II study of caspofungin as first-line therapy of invasive aspergillosis in haematological patients. J Antimicrob Chemother. 2009 Dec;64(6):1274-81. doi: 10.1093/jac/dkp355. Epub 2009 Oct 19.

family: Viscoli

full_name: C. Viscoli

given: C.

family: Herbrecht

full_name: R. Herbrecht

given: R.

family: Akan

full_name: H. Akan

given: H.

family: Baila

full_name: L. Baila

given: L.

family: Sonet

full_name: A. Sonet

given: A.

family: Gallamini

full_name: A. Gallamini

family: Giagounidis

full_name: A. Giagounidis

family: Marchetti

full_name: O. Marchetti

given: O.

family: Martino

full_name: R. Martino

family: Meert

full_name: L. Meert

family: Paesmans

full_name: M. Paesmans

given: M.

family: Ameye

full_name: L. Ameye

family: Shivaprakash

full_name: M. Shivaprakash

family: Ullmann

full_name: A. J. Ullmann

given: A. J.

family: Maertens

full_name: J. Maertens

given: J.

name: on behalf of the Infectious Disease Group of the EORTC

journal_name: Journal of Antimicrobial Chemotherapy

repository_institution: Université de Lausanne - SERVAL

repository_institution: reroDoc Digital Library

repositories_institution:
Université de Lausanne - SERVAL
reroDoc Digital Library

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Italy Switzerland France Slovakia Belgium Turkey Germany

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Medizinische Poliklinik, Universitaet Wuerzburg

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Hacettepe University - Faculty of Medicine

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore


title: Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Advanced/Metastatic Urothelial Tract Tumors

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have metastatic cancer of the urinary tract.

location_country: Italy Switzerland Netherlands France Israel Belgium Spain

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc


title: A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of liposomal doxorubicin is more effective for metastatic breast cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of liposomal doxorubicin in treating women who have metastatic breast cancer.

ReferenceCitation: Biganzoli L, Coleman R, Minisini A, Hamilton A, Aapro M, Therasse P, Mottino G, Bogaerts J, Piccart M. A joined analysis of two European Organization for the Research and Treatment of Cancer (EORTC) studies to evaluate the role of pegylated liposomal doxorubicin (Caelyx) in the treatment of elderly patients with metastatic breast cancer. Crit Rev Oncol Hematol. 2007 Jan;61(1):84-9. Epub 2006 Nov 20.

ReferenceCitation: Coleman RE, Biganzoli L, Canney P, Dirix L, Mauriac L, Chollet P, Batter V, Ngalula-Kabanga E, Dittrich C, Piccart M. A randomised phase II study of two different schedules of pegylated liposomal doxorubicin in metastatic breast cancer (EORTC-10993). Eur J Cancer. 2006 May;42(7):882-7. Epub 2006 Mar 7.

location_country:
Italy
Austria
Switzerland
Netherlands
France
Greece
Israel
Spain
United Kingdom

location_facility: Ludwig Boltzmann - Institute for Applied Cancer Research

location_facility: Mario Negri Institute for Pharmacological Research

location_facility: Istituti Fisioterapici Ospitalieri - Roma


title: Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Pancreatic Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hydration with a saline solution may protect kidney cells from the side effects of chemotherapy.

PURPOSE: Randomized phase II trial to compare the effectiveness of glufosfamide with or without hydration in treating patients who have pancreatic cancer that is metastatic or cannot be removed by surgery.

ReferenceCitation: Briasoulis E, Pavlidis N, Terret C, Bauer J, Fiedler W, Schöffski P, Raoul JL, Hess D, Selvais R, Lacombe D, Bachmann P, Fumoleau P. Glufosfamide administered using a 1-hour infusion given as first-line treatment for advanced pancreatic cancer. A phase II trial of the EORTC-new drug development group. Eur J Cancer. 2003 Nov;39(16):2334-40.

location_country: Switzerland Netherlands France Greece Israel Denmark Germany

location_facility: Academisch Ziekenhuis der Vrije Universiteit

location_facility: Herlev Hospital - University Hospital of Copenhagen

location_facility: Haemato-Onkologische Praxis und Tagesklinik


title: A Phase II Open-label Study Evaluating Valemetostat Tosylate as a Single Agent in Patients With Relapse/Refractory B-cell Lymphoma

summary: This is a multicenter, prospective, single arm, non-randomized, open-label, phase 2 clinical study to evaluate safety and efficacy of valemetostat tosylate (DS-3201b) in patients with relapsed or refractory B cell lymphoma with 6 cohorts of patients including 2 biology-driven cohorts. Up to 141 patients will be enrolled in 6 different cohorts (40 patients with aggressive B-cell lymphoma, 41 with follicular lymphoma (FL), 20 with Mantle Cell Lymphoma (MCL) and 20 with other indolent lymphomas, and 20 patients with Hodgkin lymphoma (HL)). FL patients with EZH2 mutant (gain of function mutations) will be enrolled in the cohort 2bis. At least 8 aggressive B-cell lymphoma patients with EZH2 mutant will be enrolled in the cohort 1. The primary endpoint is the overall response rate (ORR) determined by investigator assessment.

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Belgium France

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: Service des Maladies du Sang - CHRU de Lille


ReferenceCitation: Kamar N, Cassuto E, Piotti G, Govoni M, Ciurlia G, Geraci S, Poli G, Nicolini G, Mariat C, Essig M, Malvezzi P, Le Meur Y, Garrigue V, Del Bello A, Rostaing L. Pharmacokinetics of Prolonged-Release Once-Daily Formulations of Tacrolimus in De Novo Kidney Transplant Recipients: A Randomized, Parallel-Group, Open-Label, Multicenter Study. Adv Ther. 2019 Feb;36(2):462-477. doi: 10.1007/s12325-018-0855-1. Epub 2018 Dec 14.

family: Kamar

full_name: Nassim Kamar

given: Nassim

family: Cassuto

full_name: Elisabeth Cassuto

given: Elisabeth

family: Piotti

full_name: Giovanni Piotti

given: Giovanni

family: Govoni

full_name: Mirco Govoni

given: Mirco

family: Ciurlia

full_name: Giorgia Ciurlia

given: Giorgia

family: Geraci

full_name: Silvia Geraci

given: Silvia

family: Poli

full_name: Gianluigi Poli

given: Gianluigi

family: Nicolini

full_name: Gabriele Nicolini

given: Gabriele

family: Mariat

full_name: Christophe Mariat

given: Christophe

family: Essig

full_name: Marie Essig

given: Marie

family: Malvezzi

full_name: Paolo Malvezzi

given: Paolo

family: Le Meur

full_name: Yannick Le Meur

given: Yannick

family: Garrigue

full_name: Valerie Garrigue

given: Valerie

family: Del Bello

full_name: Arnaud Del Bello

given: Arnaud

family: Rostaing

full_name: Lionel Rostaing

given: Lionel

journal_name: Advances in Therapy

lead_sponsor: Chiesi Farmaceutici S.p.A.

location_facility: CHU Rangueil, 1 avenue J Poulhes TSA 50032.

location_facility: Nephrology department CHU de Saint-Etienne Hospital Nord

location_facility: Nephrology Department Hopital La Cavale Blanche

location_facility: Unité de transplantation rénale -Hopital Pasteur

title: OPEN-LABEL, MULTICENTRE, RANDOMIZED CLINICAL TRIAL TO COMPARE THE PHARMACOKINETICS OF ENVARSUS® TABLETS AND ADVAGRAF® CAPSULES ADMINISTERED ONCE DAILY IN ADULT DE-NOVO KIDNEY TRANSPLANT PATIENTS

summary: Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney transplant patients.


title: A Prospective Phase II Study of Bendamustine in Patients Aged Over 60 Years With Classical Hodgkin Lymphoma Treated by Prednisone, Vinblastine and Doxorubicin

acronym: PVAB

summary: This study evaluates bendamustine in patients aged over 60 years with classical Hodgkin Lymphoma treated by prednisone, vinblastine and doxorubicin. 90 patients will be enrolled in this study.

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie

location_facility: CHR de Metz-Thionville - Hôpital de Mercy

location_facility: Centre Hospitalier Annecy-Genevois - Site d'Annecy


title: Oedematous Lower Limb Subcutaneous Drainage in Palliative Care

acronym: DSOPAL

summary:
Background : Edema of lower extremities is a concern ranging from 19 % to 60% of palliative cancer patients. Lymphedema decreases mobility, induces pain, impacts daily activities, esthetic and behavior. Usual treatment is based on diuretics and physiotherapy but is often unsuccessful. In case of conventional treatment failure, in palliative care, subcutaneous drainage can be discussed with the patients. The technique is simple, easy to use but remains off the record. Since 2004, 23 cases were reported with various methods. All the cases reported were undertaken with various technical approaches and efficacy criteria.
Purpose : Investigator hypothesize that the subcutaneous drainage of edema (SDO) is effective in case of refractory lymphedema of the lower limbs in palliative care and leads to an improvement in QOL in terms of behavioral and autonomy.

lead_sponsor: University Hospital, Limoges

location_facility:
Joseph Ducuing hospital
Hospital
University hospital


title: In Vivo and ex Vivo Validation of MR Tractography of Brain White Matter Tracts - FIBRATLAS II-III

acronym: FIBRATLAS

summary:
White matter tracts connect cortical areas to other parts of the cortex, to basal ganglia and to the brain stem and spinal cord. These tracts form the internal part of the brain and transmit the nervous impulses. Changes in brain white matter may serve as biomarkers for numerous neurological diseases.

Diffusion Weighted Imaging (DWI) is a non-invasive MRI (Magnetic Resonance Imaging) technique providing information on white matter tracts (tractography) by studying water diffusion. Since it is based on complex mathematical models that only indirectly evaluates the underlying anatomy, tractography need to be validated before being used for research and clinical purposes. Several validation techniques were previously proposed, none of them being fully convincing in human.

primary_purpose: Basic Science

location_facility:
University Hospital of Tours
University Hospital of Amiens
University Hospital of Brest
University Hospital of Nancy
Hospital of Charpennes - Lyon
University Hospital of Rennes
University Hospital of Angers


title: Treatment of Brain AVMs (TOBAS) Study: A Randomized Controlled Trial and Registry

acronym: TOBAS

summary:
The objectives of this study and registry are to offer the best management possible for patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty. Management may include interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or in combination) or conservative management.

The trial has been designed to test a) whether medical management or interventional therapy will reduce the risk of death or debilitating stroke (due to hemorrhage or infarction) by an absolute magnitude of about 15% (over 10 years) for unruptured AVMs (from 30% to 15%); and, b) to test if endovascular treatment can improve the safety and efficacy of surgery or radiation therapy by at least 10% (80% to 90%).

As for the nested trial on the role of embolization in the treatment of Brain AVMs by other means: the pre-surgical or pre-radiosurgery embolization of cerebral AVMs can decrease the number of treatment failures from 20% to 10%. In addition,embolization of cerebral AVMs can be accomplished with an acceptable risk, defined as permanent disabling neurological complications of 8%.

ReferenceCitation: Fleetwood IG, Steinberg GK. Arteriovenous malformations. Lancet. 2002 Mar 9;359(9309):863-73. Review.

ReferenceCitation: Wedderburn CJ, van Beijnum J, Bhattacharya JJ, Counsell CE, Papanastassiou V, Ritchie V, Roberts RC, Sellar RJ, Warlow CP, Al-Shahi Salman R; SIVMS Collaborators. Outcome after interventional or conservative management of unruptured brain arteriovenous malformations: a prospective, population-based cohort study. Lancet Neurol. 2008 Mar;7(3):223-30. doi: 10.1016/S1474-4422(08)70026-7. Epub 2008 Feb 1.

ReferenceCitation: Brown RD Jr, Wiebers DO, Torner JC, O'Fallon WM. Frequency of intracranial hemorrhage as a presenting symptom and subtype analysis: a population-based study of intracranial vascular malformations in Olmsted Country, Minnesota. J Neurosurg. 1996 Jul;85(1):29-32.

ReferenceCitation: Brown RD Jr, Wiebers DO, Forbes G, O'Fallon WM, Piepgras DG, Marsh WR, Maciunas RJ. The natural history of unruptured intracranial arteriovenous malformations. J Neurosurg. 1988 Mar;68(3):352-7.

ReferenceCitation: Wilkins RH. Natural history of intracranial vascular malformations: a review. Neurosurgery. 1985 Mar;16(3):421-30. Review.

ReferenceCitation: da Costa L, Wallace MC, Ter Brugge KG, O'Kelly C, Willinsky RA, Tymianski M. The natural history and predictive features of hemorrhage from brain arteriovenous malformations. Stroke. 2009 Jan;40(1):100-5. doi: 10.1161/STROKEAHA.108.524678. Epub 2008 Nov 13.

ReferenceCitation: Gross BA, Du R. Natural history of cerebral arteriovenous malformations: a meta-analysis. J Neurosurg. 2013 Feb;118(2):437-43. doi: 10.3171/2012.10.JNS121280. Epub 2012 Nov 30. Review.

ReferenceCitation: Hernesniemi JA, Dashti R, Juvela S, Väärt K, Niemelä M, Laakso A. Natural history of brain arteriovenous malformations: a long-term follow-up study of risk of hemorrhage in 238 patients. Neurosurgery. 2008 Nov;63(5):823-9; discussion 829-31. doi: 10.1227/01.NEU.0000330401.82582.5E.

ReferenceCitation: Hartmann A, Mast H, Mohr JP, Koennecke HC, Osipov A, Pile-Spellman J, Duong DH, Young WL. Morbidity of intracranial hemorrhage in patients with cerebral arteriovenous malformation. Stroke. 1998 May;29(5):931-4.

ReferenceCitation: Hartmann A, Mast H, Mohr JP, Pile-Spellman J, Connolly ES, Sciacca RR, Khaw A, Stapf C. Determinants of staged endovascular and surgical treatment outcome of brain arteriovenous malformations. Stroke. 2005 Nov;36(11):2431-5. Epub 2005 Oct 13.

ReferenceCitation: Hartmann A, Stapf C, Hofmeister C, Mohr JP, Sciacca RR, Stein BM, Faulstich A, Mast H. Determinants of neurological outcome after surgery for brain arteriovenous malformation. Stroke. 2000 Oct;31(10):2361-4.

ReferenceCitation: Cockroft KM, Chang KE, Lehman EB, Harbaugh RE. AVM Management Equipoise Survey: physician opinions regarding the management of brain arteriovenous malformations. J Neurointerv Surg. 2014 Dec;6(10):748-53. doi: 10.1136/neurintsurg-2013-011030. Epub 2013 Dec 6.

ReferenceCitation: Cockroft KM. Unruptured brain arteriovenous malformations should be treated conservatively: no. Stroke. 2007 Dec;38(12):3310-1. Epub 2007 Oct 25.

ReferenceCitation: Stapf C, Mohr JP. Unruptured brain arteriovenous malformations should be treated conservatively: yes. Stroke. 2007 Dec;38(12):3308-9. Epub 2007 Oct 25.

ReferenceCitation: van Beijnum J, van der Worp HB, Buis DR, Al-Shahi Salman R, Kappelle LJ, Rinkel GJ, van der Sprenkel JW, Vandertop WP, Algra A, Klijn CJ. Treatment of brain arteriovenous malformations: a systematic review and meta-analysis. JAMA. 2011 Nov 9;306(18):2011-9. doi: 10.1001/jama.2011.1632. Review.

ReferenceCitation: Davies JM, Yanamadala V, Lawton MT. Comparative effectiveness of treatments for cerebral arteriovenous malformations: trends in nationwide outcomes from 2000 to 2009. Neurosurg Focus. 2012 Jul;33(1):E11. doi: 10.3171/2012.5.FOCUS12107.

ReferenceCitation: Morgan MK, Davidson AS, Koustais S, Simons M, Ritson EA. The failure of preoperative ethylene-vinyl alcohol copolymer embolization to improve outcomes in arteriovenous malformation management: case series. J Neurosurg. 2013 May;118(5):969-77. doi: 10.3171/2012.11.JNS112064. Epub 2013 Jan 25.

ReferenceCitation: Pierot L, Fiehler J, Cognard C, Söderman M, Spelle L. Will a randomized trial of unruptured brain arteriovenous malformations change our clinical practice? AJNR Am J Neuroradiol. 2014 Mar;35(3):416-7. doi: 10.3174/ajnr.A3867. Epub 2014 Jan 16.

ReferenceCitation: Raymond J; TEAM collaborative group. Reflections on the TEAM trial: why clinical care and research should be reconciled. Can J Neurol Sci. 2011 Mar;38(2):198-202.

ReferenceCitation: Saatci I, Geyik S, Yavuz K, Cekirge HS. Endovascular treatment of brain arteriovenous malformations with prolonged intranidal Onyx injection technique: long-term results in 350 consecutive patients with completed endovascular treatment course. J Neurosurg. 2011 Jul;115(1):78-88. doi: 10.3171/2011.2.JNS09830. Epub 2011 Apr 8.

ReferenceCitation: Spetzler RF, Martin NA. A proposed grading system for arteriovenous malformations. J Neurosurg. 1986 Oct;65(4):476-83.

ReferenceCitation: Magro E, Gentric JC, Batista AL, Kotowski M, Chaalala C, Roberge D, Weill A, Stapf C, Roy D, Bojanowski MW, Darsaut TE, Klink R, Raymond J. The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research. J Neurosurg. 2018 Jun;128(6):1823-1829. doi: 10.3171/2017.2.JNS162751. Epub 2017 Sep 1.

name: 1Service de Neurochirurgie, CHU Cavale Blanche, INSERM UMR 1101 LaTIM, Brest;

family: Magro

full_name: Elsa Magro

given: Elsa

name: 2Service de Radiologie, CHU Cavale Blanche, INSERM EA 3878 GETBO, Brest, France;

family: Gentric

full_name: Jean-Christophe Gentric

given: Jean-Christophe

name: 3Department of Radiology, Service of Neuroradiology, Notre-Dame Hospital, Centre Hospitalier de l’Université de Montréal (CHUM), Montreal;

family: Batista

full_name: André Lima Batista

given: André Lima

family: Kotowski

full_name: Marc Kotowski

given: Marc

name: 4Department of Surgery, Service of Neurosurgery,

family: Chaalala

full_name: Chiraz Chaalala

given: Chiraz

family: Roberge

full_name: David Roberge

given: David

family: Weill

full_name: Alain Weill

given: Alain

name: 6Department of Neurosciences, Centre Hospitalier de l’Université de Montréal (CHUM), Montreal, Quebec;

family: Stapf

full_name: Christian Stapf

given: Christian

family: Roy

full_name: Daniel Roy

given: Daniel

family: Bojanowski

full_name: Michel W. Bojanowski

given: Michel W.

name: 7Department of Surgery, Division of Neurosurgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, Edmonton, Alberta; and

family: Darsaut

full_name: Tim E. Darsaut

given: Tim E.

name: 8Interventional Neuroradiology Laboratory, Centre Hospitalier de l’Université de Montréal (CHUM) Research Centre, Montreal, Quebec, Canada

family: Klink

full_name: Ruby Klink

given: Ruby

family: Raymond

full_name: Jean Raymond

given: Jean

journal_name: Journal of Neurosurgery

publisher: Journal of Neurosurgery Publishing Group (JNSPG)

publisher_dissemination: American Association of Neurological Surgeons

ReferenceCitation: Magro E, Gentric JC, Darsaut TE, Batista AL, Chaalala C, Roberge D, Weill A, Roy D, Bojanowski MW, Raymond J. [Treatment of brain AVMS (TOBAS): A randomized controlled trial and registry]. Neurochirurgie. 2016 Aug;62(4):197-202. doi: 10.1016/j.neuchi.2015.12.008. Epub 2016 May 25. French.

full_name: E. Magro

given: E.

full_name: J.-C. Gentric

title: Le traitement des MAVS cérébrales (TOBAS) : une étude randomisée controlée avec registre

ReferenceCitation: Darsaut TE, Magro E, Gentric JC, Batista AL, Chaalala C, Roberge D, Bojanowski MW, Weill A, Roy D, Raymond J. Treatment of Brain AVMs (TOBAS): study protocol for a pragmatic randomized controlled trial. Trials. 2015 Nov 4;16:497. doi: 10.1186/s13063-015-1019-0.

lead_sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

location_facility: Centre Hospitalier Régional Universitaire de Tours

location_facility: Centre Hospit Régional Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire Hôpitaux de Rouen

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Régional Universitaire de Nancy

location_facility: University of New Mexico Health Sciences Center

location_facility: CHRU de Brest (Brest University Hospital)

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Assistance Publique - Hôpitaux de Marseille

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Les Hôpitaux Universitaires de Strasbourg

location_facility: Centre Hospitalier Universitaire de Lyon

location_facility: Centre Hospitalier de l'Université de Montréal

location_facility: Centre Hospitalier Universitaire de Caen


title: Effect of Bosentan in Patients With Non Arteritic Ischemic Optic Neuropathy

acronym: ENDOTHELION

summary: Acute ischemic optic neuropathy are the second leading cause of optic neuropathy after glaucoma in the population aged over 50 years. The visual prognosis of the condition is unfavorable in the great majority of cases, with significant effects on the visual field and vision. The severity of the unilateral condition is also associated with bilateralization in 15% at 5 years. There is no effective treatment for the acute phase of the disease or to reduce the rate of bilateralization. In this context, it is essential to develop new therapeutic strategies in the acute phase of the disease to reduce the anatomical optic nerve damage.

lead_sponsor: University Hospital, Grenoble

location_facility: University Hospital of Grenoble Michallon

location_facility: Ophtalmological fondation of Rothschild + Bichat Hospital


title: Phase 3 Prospective, Multicentric Randomized Study of Endoscopic Versus Surgical Treatment of Bile Duct Stricture in Chronic Pancreatitis

acronym: PASTEC

summary:
Biliary obstruction complicates the course of chronic pancreatitis in 3%-23% of patients and in these cases, endoscopy and surgery are the treatment modalities of choice. Morbid-mortality of these procedures is similar and physicians face the decision between endoscopy and surgery for this group of patients, with no randomized controlled trial available comparing these procedures.

The PASTEC trial is a multicenter, phase III, randomized, comparing the effectiveness of surgical and endoscopic interventions in the management of bile duct stricture for chronic pancreatitis.

The primary end point is 18-months normalization of serum alkaline phosphatase. Secondary end points are morbid-mortality rate, quality of life, numbers of endoscopic or surgical procedures, length of stay. Eighty-six patients need to be included.

lead_sponsor: University Hospital, Lille

location_facility:
Centre hospitalier
Hôpital St Philibert
Centre Hospitalier Dr Schaffner
Clinique de la Louvière


title: Moderate Hypofractionated Radiotherapy (62 Gy in 20 Fractions of 3.1 Gy) Versus Stereotactic Radiotherapy (37.5 Gy in 5 Fractions of 7.5 Gy) With Hyaluronic Acid Injection Between the Prostate and the Rectum for Prostate Cancer of Low- to Intermediate Risk; RPAH2

summary:
The present randomized, open, multicentric Phase II trial, in parallel groups with two arms of treatment, compares the treatment A, moderate hypofractionated radiotherapy of 62Gy, to treatment B, stereotactic irradiation of 37.5 Gy with hyaluronic acid injection in the space between the prostate and the rectum to preserve the rectal-wall from high doses of irradiation. The study aims to assess the rates of late urinary toxicities of grade ≥ 2 induced by a moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and by a stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy), and the rectal toxicities after an injection of hyaluronic acid between the rectal wall and the prostate.

Ninety-six patients and 9 centers are included in the protocol.

ReferenceCitation: Jmour O, Benna M, Champagnol P, Ben Mrad M, Hamrouni A, Obeid L, Lahmamssi C, Bousarsar A, Vial N, Rehailia-Blanchard A, Sotton S, Lan M, Langrand-Escure J, Vallard A, Magné N. CBCT evaluation of inter- and intra-fraction motions during prostate stereotactic body radiotherapy: a technical note. Radiat Oncol. 2020 Apr 19;15(1):85. doi: 10.1186/s13014-020-01534-2.

family: Jmour

full_name: Omar Jmour

given: Omar

family: Benna

full_name: Marouan Benna

given: Marouan

family: Champagnol

full_name: Pierre Champagnol

given: Pierre

family: Ben Mrad

full_name: Majed Ben Mrad

given: Majed

family: Hamrouni

full_name: Anis Hamrouni

given: Anis

family: Obeid

full_name: Layal Obeid

given: Layal

family: Lahmamssi

full_name: Chaimaa Lahmamssi

given: Chaimaa

family: Bousarsar

full_name: Amal Bousarsar

given: Amal

family: Vial

full_name: Nicolas Vial

given: Nicolas

family: Rehailia-Blanchard

full_name: Amel Rehailia-Blanchard

given: Amel

family: Sotton

full_name: Sandrine Sotton

given: Sandrine

family: Lan

full_name: Meiling Lan

given: Meiling

family: Langrand-Escure

full_name: Julien Langrand-Escure

given: Julien

family: Vallard

full_name: Alexis Vallard

given: Alexis

family: Magné

full_name: Nicolas Magné

journal_name: Radiation Oncology

location_facility: Site Hospitalier Nord Boulevard Jacques Monod

location_facility: Clinique Claude Bernard Service de radiothérapie CMCO Claude Bernard