title: Evaluation of Clinical and Imaging Criteria, and Plasma Biomarkers of Patients Receiving an Endovascular Treatment for an Acute Ischemic Stroke

acronym: ETIS

summary: Study like register with biomarkers samples for patient experiencing acute ischemic stroke, to assess clinical outcomes and different factors that may affect the clinical outcomes.

time_perspective: Other

ReferenceCitation: Douarinou M, Gory B, Consoli A, Lapergue B, Kyheng M, Labreuche J, Anadani M, Blanc R, Marnat G, Bourcier R, Sibon I, Eugène F, Vannier S, Audibert G, Mione G, Richard S; ETIS Investigators. Impact of Strategy on Clinical Outcome in Large Vessel Occlusion Stroke Successfully Reperfused: ETIS Registry Results. Stroke. 2021 Nov 3:STROKEAHA121034422. doi: 10.1161/STROKEAHA.121.034422. [Epub ahead of print]

name: Université de Lorraine, CHRU-Nancy, Stroke Unit, CIC-P 1433, INSERM U1116, France (M.D., G.M., S.R.).

family: Douarinou

full_name: Marian Douarinou

given: Marian

name: Department of Neuroradiology, Université de Lorraine, CHRU-Nancy, INSERM U1254, France (B.G.).

family: Gory

full_name: Benjamin Gory

given: Benjamin

name: Department of Neuroradiology, Foch Hospital, Versailles Saint-Quentin en Yvelines University, Suresnes, France. (A.C.)

family: Consoli

full_name: Arturo Consoli

given: Arturo

name: Department of Neurology, Foch Hospital, Versailles Saint-Quentin en Yvelines University, Suresnes, France. (B.L.)

family: Lapergue

full_name: Bertrand Lapergue

given: Bertrand

name: Université de Lille, CHU Lille, EA 2694, France (M.K., J.L.).

family: Kyheng

full_name: Maeva Kyheng

given: Maeva

family: Labreuche

full_name: Julien Labreuche

given: Julien

name: Department of Neurology, Washington University School of Medicine, St Louis, MO (M.A.).

family: Anadani

full_name: Mohammad Anadani

given: Mohammad

name: Department of Neuroradiology, Rothschild Foundation, Paris, France (R.B.).

name: Department of Neuroradiology, University Hospital of Nantes, INSERM 1087, UNIV Nantes, France (R.B.).

family: Blanc

full_name: Raphael Blanc

given: Raphael

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

family: Marnat

full_name: Gaultier Marnat

given: Gaultier

family: Bourcier

full_name: Romain Bourcier

given: Romain

name: Department of Neurology, University Hospital of Bordeaux, France. (I.S.)

family: Sibon

full_name: Igor Sibon

given: Igor

name: Department of Neuroradiology, University Hospital of Rennes, France. (F.E.)

family: Eugène

full_name: François Eugène

given: François

name: Department of Neurology, University Hospital of Rennes, France. (S.V.)

family: Vannier

full_name: Stéphane Vannier

given: Stéphane

name: Department of Anesthesiology and Surgical Intensive Care, Université de Lorraine, CHRU-Nancy, France (G.A.).

family: Audibert

full_name: Gérard Audibert

family: Mione

full_name: Gioia Mione

given: Gioia

family: Richard

full_name: Sébastien Richard

given: Sébastien

family: Piotin

full_name: Michel Piotin

given: Michel

family: Redjem

full_name: Hocine Redjem

given: Hocine

family: Escalard

full_name: Simon Escalard

given: Simon

family: Dessilles

full_name: Jean-Philippe Dessilles

given: Jean-Philippe

family: Delvoye

full_name: François Delvoye

family: Smajda

full_name: Stanislas Smajda

given: Stanislas

family: Maier

full_name: Benjamin Maier

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Happi Ngankou E, Gory B, Marnat G, Richard S, Bourcier R, Sibon I, Dargazanli C, Arquizan C, Maïer B, Blanc R, Lapergue B, Consoli A, Vannier S, Spelle L, Denier C, Boulanger M, Gauberti M, Saleme S, Macian F, Clarençon F, Rosso C, Naggara O, Turc G, Ozkul-Wermester O, Papagiannaki C, Viguier A, Cognard C, Lebras A, Evain S, Wolff V, Pop R, Timsit S, Gentric JC, Bourdain F, Veunac L, Eugène F, Finitsis S; ETIS Registry Investigators†. Thrombectomy Complications in Large Vessel Occlusions: Incidence, Predictors, and Clinical Impact in the ETIS Registry. Stroke. 2021 Dec;52(12):e764-e768. doi: 10.1161/STROKEAHA.121.034865. Epub 2021 Oct 28.

name: Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, CHRU-Nancy, France. (E.H.N., B.G.)

name: IADI, INSERM U1254, Université de Lorraine, Nancy, France (B.G.).

name: Department of Diagnostic and Interventional Neuroradiology, University Hospital of Bordeaux, France (G.M.).

name: Department of Neurology, Stroke Unit, Université de Lorraine, CHRU-Nancy, France. (S.R.)

name: CIC-P 1433, INSERM U1116, CHRU-Nancy, France (S.R.).

name: Department of Neuroradiology, University Hospital of Nantes, France (R.B.).

name: Department of Neurology, Stroke Center, University Hospital of Bordeaux, France (I.S.).

name: Department of Interventional Neuroradiology, CHRU Gui de Chauliac, Montpellier, France. (C.D.)

name: Department of Neurology, CHRU Gui de Chauliac, Montpellier, France. (C.A.)

name: Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France (B.M., R.B.).

name: Department of Diagnostic and Interventional Neuroradiology, Foch Hospital, Versailles Saint-Quentin en Yvelines University, Suresnes, France. (A.C.)

name: Department of Neurology, Stroke Unit, University Hospital of Rennes, France. (S.V.)

name: Department of Neuroradiolology, CHU Kremlin Bicêtre, Paris, France. (L.S.)

name: Department of Neurology, CHU Kremlin Bicêtre, Paris, France. (C.D.)

name: Department of Neurology, CHU Caen, France. (M.B.)

name: Department of Neuroradiolology, CHU Caen, France. (M.G.)

name: Department of Interventional Neuroradiology, CHU Limoges, France. (S.S.)

name: Neurology, Stroke Unit, CHU Limoges, France. (F.M.)

name: Department of Neuroradiolology, CHU Pitié-Salpétrière, Paris, France. (F.C.)

name: Department of Neurology, CHU Pitié-Salpétrière, Paris, France. (C.R.)

name: Department of Neuroradiolology, Hôpital Saint Anne, Paris, France. (O.N.)

name: Department of Neurology, Hôpital Saint Anne, Paris, France. (G.T.)

name: Department of Neurology, CHU Rouen, France. (O.O.-W.)

name: Department of Neuroradiolology, CHU Rouen, France. (C.P.)

name: Department of Neurology, CHU Toulouse, France. (A.V.)

name: Department of Neuroradiolology, CHU Toulouse, France. (C.C.)

name: Department of Neurology, CH Bretagne Atlantique, Vannes, France. (A.L.)

name: Department of Neuroradiolology, CH Bretagne Atlantique, Vannes, France. (S.E.)

name: Department of Neurology, CHU Strasbourg, France. (V.W.)

name: Department of Neuroradiolology, CHU Strasbourg, France. (R.P.)

name: Department of Neurology,. CHU Brest, France. (S.T.)

name: Department of Neuroradiolology, CHU Brest, France. (J.-C.G.)

name: Department of Neurology, CH Côte Basque, Bayonne, France. (F.B.)

name: Department of Neuroradiolology, CH Côte Basque, Bayonne, France. (L.V.)

name: Ahepa Hospital, Aristotle University of Thessaloniki, Greece (S.F.).

ReferenceCitation: Aubertin M, Weisenburger-Lile D, Gory B, Richard S, Blanc R, Ducroux C, Piotin M, Labreuche J, Lucas L, Dargazanli C, Benali A, Bourcier R, Detraz L, Vannier S, Guillen M, Eugene F, Walker G, Lun R, Guenego A, Consoli A, Marnat G, Maier B, Lapergue B, Fahed R; ETIS Investigators*. First-Pass Effect in Basilar Artery Occlusions: Insights From the Endovascular Treatment of Ischemic Stroke Registry. Stroke. 2021 Dec;52(12):3777-3785. doi: 10.1161/STROKEAHA.120.030237. Epub 2021 Aug 26.

ReferenceCitation: Ducroux C, Renaud N, Bourcier R, Marnat G, Sibon I, Gory B, Richard S, Dargazanli C, Arquizan C, Eugene F, Vannier S, Labreuche J, Walker G, Blanc R, Obadia M, Consoli A, Lapergue B, Fahed R; ETIS investigators. Embolus Retriever with Interlinked Cages (ERIC) versus conventional stent retrievers for thrombectomy: a propensity score-based analysis. J Neurointerv Surg. 2021 Mar;13(3):255-260. doi: 10.1136/neurintsurg-2020-016289. Epub 2020 Jun 30.

ReferenceCitation: Boisseau W, Fahed R, Lapergue B, Desilles JP, Zuber K, Khoury N, Garcia J, Maïer B, Redjem H, Ciccio G, Smajda S, Escalard S, Taylor G, Mazighi M, Michel P, Gory B, Blanc R; ETIS Investigators. Predictors of Parenchymal Hematoma After Mechanical Thrombectomy: A Multicenter Study. Stroke. 2019 Sep;50(9):2364-2370. doi: 10.1161/STROKEAHA.118.024512. Epub 2019 Jul 22.

name: From the Interventional Neuroradiology Unit, Fondation Rothschild Hospital, Paris, France (W.B., R.F., J.-P.D., K.Z., B.M., H.R., G.C., S.S., S.E., M.M., M.P., R.B.)

name: Neurovascular Unit, Foch Hospital, Suresnes, France (B.L., J.G.)

name: Université Paris Denis Diderot, Sorbonne Paris Cite, France (J.-P.D., M.M., M.P., R.B.)

name: Laboratory of Vascular Translational Science, U1148 Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, France (J.-P.D., M.M., M.P., R.B.)

name: HSHS Neuroscience Center, HSHS St John's Hospital, Springfield, IL (N.K.)

name: Department of Intensive Care, Rothschild Foundation Hospital, Paris, France (G.T.)

name: Department of Diagnostic and Therapeutic Neuroradiology, Nancy Hospital, France (B.G.)

name: University of Lorraine, INSERM U1254, IADI, Nancy, France (B.G.).

location_facility:
CHU de Caen
Hôpital le Kremlin-Bicètre - APHP
CHU Toulouse
Hôpital SAINTE ANNE
CHU Dupuytren
Chu Rouen
Hôpital Foch
CHU Lyon
CHU Bordeaux
CHU Montpellier
Fondation Ophtalmique de Rotschild
CHU Nantes
CHU Nancy
Hôpital Pitié Salpétrière
CHU Rennes
CH Bretagne Atlantique


ReferenceType: derived

ReferenceCitation: Kerckhove N, Busserolles J, Stanbury T, Pereira B, Plence V, Bonnetain F, Krakowski I, Eschalier A, Pezet D, Balayssac D. Effectiveness assessment of riluzole in the prevention of oxaliplatin-induced peripheral neuropathy: RILUZOX-01: protocol of a randomised, parallel, controlled, double-blind and multicentre study by the UNICANCER-AFSOS Supportive Care intergroup. BMJ Open. 2019 Jun 9;9(6):e027770. doi: 10.1136/bmjopen-2018-027770.

family: Kerckhove

full_name: Nicolas Kerckhove

given: Nicolas

sequence: first

family: Busserolles

full_name: Jérome Busserolles

given: Jérome

sequence: additional

family: Stanbury

full_name: Trevor Stanbury

given: Trevor

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Plence

full_name: Valérie Plence

given: Valérie

family: Bonnetain

full_name: Franck Bonnetain

given: Franck

family: Krakowski

full_name: Ivan Krakowski

given: Ivan

family: Eschalier

full_name: Alain Eschalier

given: Alain

family: Pezet

full_name: Denis Pezet

given: Denis

family: Balayssac

full_name: David Balayssac

given: David

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

design_allocation: Randomized

intervention_type: Drug

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

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

enrollment_type: Anticipated

primary_purpose: Prevention

location_facility:
CHU de Clermont -Ferrand
CH Annecy-Genevois
Centre François Baclesse
ICO - Site René Gauducheau
Clinique St Côme
CHU de Dijon
CHU de Reims
CHU de Saint-Etienne
Hia Begin
Centre Georges François Leclerc
Institut Jean Godinot
CH Beauvais
GHPSO
ICO - Site Paul Papin
Hia Percy
Hôpital Foch

ipd_sharing: No

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy: A Phase II Randomized Study by UNICANCER With the Cooperation of AFSOS

summary:
It is a phase II trial, randomized, parallel, double blind, multicenter, comparing riluzole versus placebo.

The trial population is composed of patients ≥18 years old that have developed stage II/III colorectal cancer and are eligible for Simplified FOLFOX4 (6-12 cycles) adjuvant chemotherapy.

The primary objective is to assess the preventive efficacy of riluzole on the severity of oxaliplatin-induced peripheral neuropathy during the Simplified FOLFOX4 adjuvant chemotherapy of stage II/III colorectal cancers.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Multicenter Randomized Clinical Trial Comparing Two Treatment Strategies to Prevent Rebleeding From Gastric Varices: "Early TIPS" Versus Glue Obliteration

acronym: GAVAPROSEC

summary: The primary objective of the study is to demonstrate the superiority of an "early tips" strategy over standard treatment by glue obliteration (G0) in preventing bleeding recurrence or death at one year after a non GOV1 gastric variceal bleeding in cirrhotic patients initially treated by GO.

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
University Hospital of Dijon
University Hospital of Marseille
University Hospital of Nantes
University Hospital of Tours
University Hospital of Bordeaux
University Hospital of Lille
Pitié Salpétrière Hospital
University Hospital of Besançon
Univerity Hospital of Bondy
University Hospital of Caen
Paul Brousse Hospital
University Hospital of Montpellier
St Antoine Hospital
University Hospital of Nice
University Hospital of Toulouse
University Hospital of Rennes
University Hospital of Angers

intervention_type: Procedure

lead_sponsor_type: academique


type: Other Identifier

title: Impact of Cardiovascular Rehabilitation on the Quality of Life of Adolescents and Young Adults With Congenital Heart Disease: A Randomized Controlled Multicentre Trial

acronym: QUALIREHAB

summary: The investigators aim to measure the impact of a rehabilitation program in congenital cardiology in terms of health related quality of life. The orginality of the rehabilitation program consists in its design : initial hospitalizationfor a short period of time (5 days) at the rehabilitation center, followed by 11 weeks of rehabilitation at home under the supervision of a specialized sports trainer.

primary_purpose: Other

ReferenceType: background

ReferenceCitation: Amedro P, Gavotto A, Legendre A, Lavastre K, Bredy C, De La Villeon G, Matecki S, Vandenberghe D, Ladeveze M, Bajolle F, Bosser G, Bouvaist H, Brosset P, Cohen L, Cohen S, Corone S, Dauphin C, Dulac Y, Hascoet S, Iriart X, Ladouceur M, Mace L, Neagu OA, Ovaert C, Picot MC, Poirette L, Sidney F, Soullier C, Thambo JB, Combes N, Bonnet D, Guillaumont S. Impact of a centre and home-based cardiac rehabilitation program on the quality of life of teenagers and young adults with congenital heart disease: The QUALI-REHAB study rationale, design and methods. Int J Cardiol. 2019 May 15;283:112-118. doi: 10.1016/j.ijcard.2018.12.050. Epub 2018 Dec 20.

lead_sponsor: University Hospital, Montpellier

location_facility: Gabriel Montpied Hospital- Clermont Ferrand University Hospital

location_facility: La Miletrie -Poitier University Hospital

location_facility: Haut Lévêques - Bordeaux University Hospital

location_facility: Arnaud de Villeneuve - University Hospital

location_facility: La Timone- Public Assistance - Marseille hospitals

location_facility: Children Hospital - Toulouse University Hospital

location_facility: Barbois Hospital - Nancy University Hospital

location_facility: Children and Mother Hospital - Limoges University Hospital

intervention_type: Other


title: Sentinel Lymph Node After Neoadjuvant Chemotherapy in Breast Carcinoma

summary:
Sentinel lymph node dissection (SLND) after NAC, aimed to reduce the rate of unnecessary axillary lymphadenectomy, is not a standard of care in case of patient with previously involved node before NAC because of a too high false negative rate (FNR).

Clinical consequences of FNR of SLND after NAC are currently unknown. Consequently, contrary to adjuvant setting, a risk of SLND false negative case after NAC is not acceptable.

GANEA3 aims to evaluate the results of an innovative multiparametric strategy combining (1) an identification before chemotherapy of a lymph node involvement using a metal clip and then its analysis after treatment, (2) the analysis of sentinel lymph node (SLN) after NAC, and (3) analysis of biological parameters of breast tumor before and after NAC, to predict axillary status after NAC. This will identify patients with initial lymph node involvement who could benefit from SLN after NAC without additional axillary dissection with a very low FNR (≤1%).

The most "pathological" metastatic lymph node will be identified with a metal clip under ultrasound. They will then receive a NAC before breast and axillary surgery. An assessment of the NAC response at the breast and axillary will be performed by imagery. Then, all patients undergo the resection of the tagged axillary node with the metal clip, SLN detection and biopsy and a complementary axillary lymphadenectomy.

ReferenceCitation: Ditsch N, Rubio IT, Gasparri ML, de Boniface J, Kuehn T. Breast and axillary surgery in malignant breast disease: a review focused on literature of 2018 and 2019. Curr Opin Obstet Gynecol. 2020 Feb;32(1):91-99. doi: 10.1097/GCO.0000000000000593. Review.

family: Ditsch

full_name: Nina Ditsch

given: Nina

family: Rubio

full_name: Isabel T. Rubio

given: Isabel T.

family: Gasparri

full_name: Maria L. Gasparri

given: Maria L.

family: de Boniface

full_name: Jana de Boniface

given: Jana

family: Kuehn

full_name: Thorsten Kuehn

given: Thorsten

journal_name: Current Opinion in Obstetrics & Gynecology

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
CHU Angers
Centre Antoine Lacassagne
Institut de Cancérologie de Montpellier
Hôpital Européen Georges Pompidou
Institut de Cancérlogie de Lorraine
Centre Jean Perrin
Centre Paul Strauss
ICO - Site ANGERS
Ico Nantes
APHP - Pitié Salpétrière
CURIE
IUCT-O
Centre Jean Godinot
Institut Bergonié
CHU Brest
Centre Georges Francoise Leclerc
Polyclinique Urbain


type: Registry Identifier

title: Coffee Consumption and NASH in the French Population.

acronym: COCANASH

summary: The aim of our study is to evaluate the effect of coffee consumption on the risk of severe liver fibrosis in French patients with NASH.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Versailles Hospital

location_facility: Centre Hospitalier Intercommunal de Créteil

status_simplified: Completed


title: "Interest of Synovial Biopsy in the Etiological Assessment of Arthritis of Undetermined Origin: Multicenter Prospective Series"

acronym: BIOPSYN

summary: Synovial biopsies are now routinely performed both in research and in clinical practice. The developments of ultrasound (US) and of US-guided needle biopsies devices have facilitated their use and tolerance by the patients. However, their interest in clinical practice in the context of an undifferentiated arthritis remains debated.

lead_sponsor: Nantes University Hospital

location_facility:
AP-HM
Chu Brest
CHU de Nancy
CHU CAEN
CHU de Bordeaux
CHU de Nice
Chu de Toulouse
Chu de Dijon
CHD La Roche-sur-Yon
CHU de Poitiers
Chu de Rennes
Chu de Montpellier
Chu d'Angers
AP-HP
Chu de Strasbourg


title: A Randomized, Open-label, Multicentric Phase II Trial of PEMBROLIZUMAB (Keytruda®) With Chemotherapy Versus Chemotherapy Alone (Standard of Care) as Neo Adjuvant Treatment of Ovarian Cancer Not Amenable to Front Line Debulking Surgery.

acronym: NEOPEMBROV

summary:
There are several data suggesting that pembrolizumab and bevacizumab may be synergistic. Enhanced tumor angiogenesis is commonly associated with absence of tumor-infiltrating T cells in patients. There is evidence in OC that tumor expression of VEGF is negatively correlated to the density of CD3+TILs and this phenotype is associated with early recurrence, consistent with prior studies showing a correlation of VEGF to early recurrence and short survival. Furthermore, in ascites, high levels of VEGF correlate to low numbers of NK T-like CD3+CD56+ cells

This randomized phase II study aims to evaluate the efficacy of pembrolizumab in combina-tion with the standard neo adjuvant chemotherapy followed by IDS and the safety of this strategy in patients with advanced ovarian cancer. We assume that its administration in the neo adjuvant setting combination with standard of care (4 cycles of standard chemotherapy) would improve the response rate and consequently will help to achieve optimal debulking rate at IDS.

After surgery, patients will continue to be treated with standard of care (chemotherapy for 2 to 5 cycles plus or less bevacizumab) or the same combination plus pembrolizumab (keytruda).

status: Active, not recruiting

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Groupe Hospitalier Diaconesses-Croix Saint Simon

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Clinical Characteristics of Pruritus and Evaluation of Quality of Life in Patients With Bullous Pemphigoid

acronym: PRURIPB

summary:
Whereas pruritus is a major symptom in bullous pemphigoid, its characteristics and its impact on quality of life have been little studied.

The objective of this study is to learn more about pruritus characteristics of patients with bullous pemphigoid, and in consequence to better understand the pathophysiology of pruritus, and then to better treat pruritus in this condition.

lead_sponsor: University Hospital, Brest

location_facility:
AP-HP, Hôpital Cochin
AP-HP, Hôpital Avicenne
HP-HM
AP-HP, Hôpital Bichat
CHU de Reims
CHU de Saint-Etienne
CHU de Bordeaux
CHU de Clermont-Ferrand
CHU Caen
CH Argenteuil
AP-HP, Hôpital Henri Mondor
CHU de Montpellier
CHRU de Brest
CH de Niort
CHU de Rouen
CHU Le Havre


title: Prospective Study Assessing the Impact of RNA Genomic Profile Defined by a Genomic Test on Treatment Decision-making in Breast Cancer Patients With an ISH Equivocal HER2 Status- EQUIVOK Study

acronym: EQUIVOK

summary:
The American Society of Clinical Oncology (ASCO) and the /College of American Pathologists (CAP) recommend that HER2 status (negative or positive) must be determined in all patients with invasive breast cancer. The knowledge of HER2 status will help the oncologist in prescribing or not a HER2-targeted therapy to patients. Presently, two main methods are used to assess HER2 status: immunohistochemistry (IHC, protein expression) and in situ hybridization (ISH, gene expression) in order to classify tumor sample as positive, negative or equivocal. When a tumor is classified HER 2+ by IHC method, a second test is performed using ISH methods (FISH, SISH, CISH). In case of HER2 equivocal result with ISH method (4 ≤HER2 gene number copy <6), the patient is eligible to an anti-HER2 therapy after discussed during MD-MM. This decision should be individualized on the basis of patient status (comorbidities and prognosis) and patient preferences after discussing available clinical evidence.

Based on molecular classification, RNA expression could help to discriminate breast cancer subtypes (luminal A, luminal B, HER2-overexpressed and triple negative). Prosigna is a genomic test, developed by NanoString® based on the PAM50 gene signature, which measures the expression of 50 genes to classify tumors into 1 of 4 intrinsic subtypes and could allow determining the HER2 status.

This study was designed in order to define if such a test could help the oncologist to define the better therapeutic decision in a HER2 equivocal population. In addition, concordance tests will be performed. The aim of this study is to assess the modification decision rate between the first and the second multidisciplinary decision-making meeting in HER2 equivocal patients using genomic testing.

status: Terminated

primary_purpose: Diagnostic

lead_sponsor: Centre Jean Perrin

location_facility:
Centre Léon Bérard
Centre François Baclesse
Institut de Cancérologie de Montpellier
Hopital DUPUYTREN
Institut de Cancérologie de l'Ouest
Centre Jean Perrin
Centre Georges François Leclerc
Institut Jean Godinot
Centre Paul Strauss
Institut Claudius Regaud
Institut de Cancérologie de Lorraine
CHRU Jean Minoz
Institut Paoli Calmettes
CHU Albert Michalon
Institut du Cancer COURLANCY
Institut Bergonie

intervention_type: Diagnostic Test

status_simplified: Unknown


title: QD Isentress as Switch Strategy in Virologically Suppressed HIV-1 Infected-Patient

acronym: QDISS

summary:
Raltegravir (RAL) is a very effective antiretroviral drug with a favorable long term tolerability. RAL offers many advantages such as lack of drug-drug interactions, a good safety profile particularly on lipids, inflammation and bone parameters. Ral can be an very interesting for patient with comorbidities and comedications, intolerance or toxicities with their current ARV treatment. However its current formulation of one tablet of 400mg twice a day coul not suit many patients.

A new once-a-day formulation of RAL has been developed, with two tablets of 600 mg QD. Pharmacokinetic study in healthy volunteers has shown that this dosing provides increased RAL exposure compared to the standard formulation of 400 mg given twice a day.

The objective of this study is to evaluate the maintain of virologic suppression with raltegravir 600mg 2 tablets qd as part of a triple antiretroviral regimen in virologically controlled patients.

location_facility:
CHU de Lyon
Hopital Necker
CHu hotel dieu
CH de la Roche Sur Yon
Hopital Avicenne
CHU de Reims
CHU of NANTES
CHRU de Montpellier
CHU de Nice
CHU de Bichat
CHU la pitié
CHRU de Tours
CH de Tourcoing
Hopital St Louis
CHU De Bordeaux
CH du Mans
CHR orléans


title: Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation

acronym: TRAP

summary: The aim of this study is to improve the definition of the two main types of secondary tricuspid regurgitation.

status: Unknown status

lead_sponsor: Rennes University Hospital

location_facility: Chu de Bordeaux - Groupe Hospitalier Sud

location_facility: CHU de DIJON - HOPITAL FRANCOIS MITTERAND


title: Improvement of Intraoperative Behavior of Staff to Prevent Postoperative Complications

summary: The aim of this interventional study is to optimize the movements and discipline of surgical staff in order to improve the quality of care, the safety of the patient in the surgery and to prevent the postoperative complications in the broad sense and in particular the infection of the surgical site. The intervention will be carried out using tools of new technologies allowing the monitoring of the movements and the sound level associated with techniques of behavior change inspired by those used in the human and social sciences.

ReferenceCitation: Birgand G, Haudebourg T, Grammatico-Guillon L, Ferrand L, Moret L, Gouin F, Mauduit N, Leux C, Le Manach Y, Lepelletier D, Tavernier E, Lucet JC, Giraudeau B. Improvement in staff behavior during surgical procedures to prevent post-operative complications (ARIBO(2)): study protocol for a cluster randomised trial. Trials. 2019 May 20;20(1):275. doi: 10.1186/s13063-019-3370-z.

family: Birgand

full_name: Gabriel Birgand

given: Gabriel

family: Haudebourg

full_name: Thomas Haudebourg

given: Thomas

family: Grammatico-Guillon

full_name: Leslie Grammatico-Guillon

given: Leslie

family: Ferrand

full_name: Léa Ferrand

given: Léa

family: Moret

full_name: Leila Moret

given: Leila

family: Gouin

full_name: François Gouin

given: François

family: Mauduit

full_name: Nicolas Mauduit

family: Leux

full_name: Christophe Leux

given: Christophe

family: Le Manach

full_name: Yannick Le Manach

given: Yannick

family: Lepelletier

full_name: Didier Lepelletier

given: Didier

family: Tavernier

full_name: Elsa Tavernier

given: Elsa

family: Lucet

full_name: Jean-Christophe Lucet

given: Jean-Christophe

family: Giraudeau

full_name: Bruno Giraudeau

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

title: Improvement in staff behavior during surgical procedures to prevent post-operative complications (ARIBO2): study protocol for a cluster randomised trial

location_facility:
Sante Atlantique
Rennes University Hospital
Hôpital Beaujon
Saint Grégoire private hospital
Vannes Hospital
Le Mans Hospital
Saint-Léonard Clinic
IMM
Tours University Hospital
H.P. Confluent
Pré surgical clinic
Angers University Hospital
Nantes University Hospital
Vendée Hospital
Saint-Nazaire Hospital
Hôpital Lariboisière


lead_sponsor: Hoffmann-La Roche

acronym: ATALK

location_facility: Centre Hospitalier Intercommunal; Service de Pneumologie

location_facility: CHRU Lille Service de Pneumologie et Oncologie Thoracique

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique

location_facility: Hopital Augustin Morvan; Oncologie Thoracique

title: An Open-Label, Multicenter, Single-Arm, Phase II Study to Assess the Efficacy and Safety of Alectinib in Patients With ALK-Rearranged Non-Small Cell Lung Cancer After Disease Progression on Prior ALK Inhibitor Therapy

summary: This study will evaluate the efficacy and safety of alectinib, in selected participants, with anaplastic lymphoma kinase-rearranged (ALK-rearranged) non-small cell lung cancer (NSCLC), after disease progression on prior treatment strategy with crizotinib, as only ALK inhibitor, and eventually chemotherapy treatment(s).


title: Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia: an Observational, Non-interventional Study

summary: This is an observational, non-interventional study that will include two cohorts of patients with schizophrenia who initiated maintenance treatment during a schizophrenia-related hospitalisation or during the immediate three months after hospital discharge: patients who initiated maintenance treatment with AOM and patients who initiated maintenance treatment with any daily oral atypical AP.

ReferenceCitation: Such P, Bøg M, Kabra MS, Jørgensen KT, de Jong-Laird AC. A Noninterventional Cohort Study Assessing Time to All-Cause Treatment Discontinuation After Initiation of Aripiprazole Once Monthly or Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-Onset Schizophrenia. Prim Care Companion CNS Disord. 2021 Sep 30;23(5). pii: 20m02886. doi: 10.4088/PCC.20m02886.

family: Such

full_name: Pedro Such

given: Pedro

family: Bøg

full_name: Martin Bøg

given: Martin

family: Kabra

full_name: Madhu S. Kabra

given: Madhu S.

family: Jørgensen

full_name: Kristian T. Jørgensen

given: Kristian T.

family: Jong-Laird

full_name: Anne C. de Jong-Laird

given: Anne C. de

journal_name: The Primary Care Companion For CNS Disorders

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Physicians Postgraduate Press, Inc

publisher_dissemination: Physicians Postgraduate Press, Inc

publisher_group: Physicians Postgraduate Press, Inc

publisher_normalized: Physicians Postgraduate Press, Inc

lead_sponsor: Otsuka Pharmaceutical Europe Ltd

location_country: Italy Germany France Spain

location_facility: Azienda Ospedaliera "Sant' Andrea" di Roma - U.O.C. di Psichiatria

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Mental Health Department (MDSM) ASP di Messina

location_facility: P.O. di Giulianova Dipartimento di Salute Mentale Servizio di Psichiatria di Diagnosi e Cura

location_facility: IINA (Instituto Internacional de Neurociencias Aplicadas)

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Dipartimento di Salute Mentale- ASL Napoli

location_facility: Ospedale Madonna del Soccorso San Bendedetto del Tronto

location_facility: Unita Operativa- Salute Mentale di Salerno

location_facility: Centre Hospitalier Gillaume regnier-CHGR

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Unit Mental Health District Nº72- ASL Salerno

location_facility: Cura Neuropsichiatria Villa Von Siebenthal

location_facility: Dipartimento di Salute Mentale -ASL Modena

location_facility: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari


title: Bronchoalveolar Lavages in the Intensive Care Unit : Indications, Adverse Respiratory Effects, Contribution to Diagnosis and Therapy. A Multicenter, Prospective, Observational Study

acronym: REA-LBA

summary:
Little is known about bronchoalveolar lavages performed for cytological assessment during bronchial fibroscopy in critically ill patients. Frequency of use, indications, actual contribution to diagnosis and therapeutic decision, and complications have not been extensively assessed.

The primary objective of this multi center, prospective, observational study is to describe the frequency of use of bronchoalveolar lavages for cytological assessement in critically ill patients, identify their indications, assess their contribution to diagnosis and therapeutic decisions, and estimate the frequency of induced respiratory events.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
CHU de STRASBOURG
Hôpital RAYMOND POINCARE
CH d'ANGOULEME
CH Victor DUPOUY
Hôpital Nord de Marseille
CH de MONTAUBAN
CHU de STRASBOURG NHC
Hopital de La Timone
CHRU de TOURS
CHR d'ORLEANS
CHD de VENDEE
CHU de DIJON
CH de LA ROCHELLE
CHRU de POITIERS
CHRU de NANTES
CHU d'ANGERS


title: Transvaginal Treatment of Anterior and Apical Genital Prolapses Using an Ultra Lightweight Mesh: Restorelle® Direct FixTM: a Retrospective Study on Feasibility and Morbidity.

acronym: Restorelle

summary: Pelvic organ prolapse repair involves conservative treatments and surgical treatments. Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic prolapse remains essentially surgical. According to detailed medical history and a thorough physical exam, surgical techniques may be performed by high abdominal, low vaginal or mixed routes with or without the use of a reinforcing implant. Restorelle Direct Fix is indicated for transvaginal anterior and posterior surgical repair either as mechanical support or as reinforcement of pelvic floor defects. Advantages and disadvantages of vaginal prostheses are known but only limited data have been reported on the use of Restorelle® in the treatment of pelvic organ prolapse. This study is designed to collect data on the safety and efficacy of Restorelle® Direct Fix in pelvic organ prolapse repair.

time_perspective: Retrospective

ReferenceCitation: Le Normand L, Cosson M, Cour F, Deffieux X, Donon L, Ferry P, Fatton B, Hermieu JF, Marret H, Meurette G, Cortesse A, Wagner L, Fritel X. [Clinical practice guidelines: Summary of recommendations for first surgical treatment of female pelvic organ prolapse by 5 French academic societies: AFU, CNGOF, SIFUD-PP, SNFCP, and SCGP]. Prog Urol. 2016 Jul;26 Suppl 1:S1-7. doi: 10.1016/S1166-7087(16)30424-9. Review. French.

ReferenceCitation: Khunda A, Vashisht A, Cutner A. New procedures for uterine prolapse. Best Pract Res Clin Obstet Gynaecol. 2013 Jun;27(3):363-79. doi: 10.1016/j.bpobgyn.2012.12.004. Epub 2013 Jan 5. Review.

ReferenceCitation: Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6.

ReferenceCitation: Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.

ReferenceCitation: Persu C, Chapple CR, Cauni V, Gutue S, Geavlete P. Pelvic Organ Prolapse Quantification System (POP-Q) - a new era in pelvic prolapse staging. J Med Life. 2011 Jan-Mar;4(1):75-81. Epub 2011 Feb 25.

ReferenceCitation: Lousquy R, Costa P, Delmas V, Haab F. [Update on the epidemiology of genital prolapse]. Prog Urol. 2009 Dec;19(13):907-15. doi: 10.1016/j.purol.2009.09.011. Epub 2009 Nov 4. Review. French.

ReferenceCitation: Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Marjoribanks J. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2016 Feb 9;2:CD012079. doi: 10.1002/14651858.CD012079. Review.

ipd_sharing: Undecided

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis


title: CombinaiR3 - First-line Treatment of Ewing Tumours With Primary Extrapulmonary Dissemination in Patients From 2 to 50 Years

summary:
Ewing's sarcoma and related tumours (ESFT) are rare tumours, with a peak incidence in the second decade of life. They start most often from bone, and are characterized by a specific translocation involving the so-called EWS gene. In one patient out of three, the staging procedures detect metastatic tumours at the diagnosis, most commonly in lungs, bones, and bone marrow.

ESFT treatment strategy is multidisciplinary, combining primary chemotherapy, a local treatment, and consolidation chemotherapy.

The primary metastatic dissemination is the most important prognostic factor, as the survival rate is around 70-75% for localized tumours, in contrast with less than 50% for patients with primary metastatic disease.

Among primary metastatic patients, bone involvement and / or bone marrow strike markedly the prognosis of these patients. While the long-term survival of patients with isolated pleural pulmonary metastases is approximately 50%, whereas it is only from 0 to 25% in patients with bone marrow involvement.

In 1999, the Intergroup EURO EWING built a new study protocol for patients with Ewing tumours. For the patients with primary extrapulmonary metastatic Ewing tumours (R3 patients), the protocol proposed a heavy induction chemotherapy, in order to propose a consolidation with high dose chemotherapy to a higher rate of patients. The high-dose Busulfan Melphalan chemotherapy (BuMel) was based on Busulfan (600 mg/m²) and Melphalan (140 mg/m²), with autologous peripheral blood stem cell (PBSC) support.

Of note, for the full population of patients with metastatic disease, the 3-year EFS rate was 27% (SD 3%), and the OS rate was 34% (SD 4%), with a median follow-up of 3.9 years after diagnosis, and a median survival time of 1.6 years.

design_allocation: Non-Randomized

lead_sponsor: Institut Curie

location_facility: NANCY Institut de Cancérologie de Lorraine

location_facility: CHRU Montpellier - Hôpital A. de Villeneuve

intervention_type: Radiation


title: Evaluation of Compliance With Treatment by Elvitegravir/Cobicistat/FTC/Tenofovir Alafenamide (E/C/F/TAF) in HIV Post-exposure Prophylaxis (to Infected Blood or Sexual Contact)

summary: This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Genvoya for four weeks

ReferenceCitation: Gantner P, Hessamfar M, Souala MF, Valin N, Simon A, Ajana F, Bouvet E, Rouveix E, Cotte L, Bani-Sadr F, Hustache-Mathieu L, Lebrette MG, Truchetet F, Galempoix JM, Piroth L, Pellissier G, Muret P, Rey D; E/C/F/TAF PEP Study Group. Elvitegravir-Cobicistat-Emtricitabine-Tenofovir Alafenamide Single-tablet Regimen for Human Immunodeficiency Virus Postexposure Prophylaxis. Clin Infect Dis. 2020 Feb 14;70(5):943-946. doi: 10.1093/cid/ciz577.

name: Laboratory of Molecular Virology, Hôpitaux Universitaires de Strasbourg, Rennes, France

name: INSERM, Strasbourg University, Hôpital Saint André, Centre Hospitalier Universitaire de Bordeaux, Rennes, France

family: Gantner

full_name: Pierre Gantner

given: Pierre

name: Service de Médecine Interne et Maladies Infectieuses, Hôpital Saint André, Centre Hospitalier Universitaire de Bordeaux, Rennes, France

family: Hessamfar

full_name: Mojgan Hessamfar

given: Mojgan

name: Service des Maladies Infectieuses et Tropicales, Centre Hospitalier Universitaire Pontchaillou, Rennes, France

family: Souala

full_name: Mohamed Faouzi Souala

given: Mohamed Faouzi

name: Service de Maladies Infectieuses et Tropicales, Hôpital Saint-Antoine, Assistance Publique–Hôpitaux de Paris (APHP), APHP, France

family: Valin

full_name: Nadia Valin

given: Nadia

name: Service de Médecine Interne et Immunologie Clinique, Hôpital Pitié-Salpêtrière, APHP, France

family: Simon

full_name: Anne Simon

given: Anne

name: Service Universitaire des Maladies Infectieuses et du Voyageur, Centre Hospitalier de Tourcoing, APHP, France

family: Ajana

full_name: Faiza Ajana

given: Faiza

name: Service de Maladies Infectieuses, Hôpital Bichat, APHP, France

family: Bouvet

full_name: Elisabeth Bouvet

given: Elisabeth

name: Service de Médecine Interne, Hôpital Ambroise Paré, APHP, France

family: Rouveix

full_name: Elisabeth Rouveix

name: Maladies Infectieuses et Tropicales, Hôpital de la Croix Rousse, Lyon, France

family: Cotte

full_name: Laurent Cotte

given: Laurent

name: Unité des Maladies Infectieuses et Tropicales, Hôpital Robert Debré, Reims, France

family: Bani-Sadr

full_name: Firouzé Bani-Sadr

given: Firouzé

name: Service des Maladies Infectieuses et Tropicales, Hôpital Jean Minjoz, Besançon, France

family: Hustache-Mathieu

full_name: Laurent Hustache-Mathieu

name: Service des Maladies Infectieuses et Tropicales, Hôpital Tenon, APHP, Paris, France

family: Lebrette

full_name: Marie-Gisèle Lebrette

given: Marie-Gisèle

name: Service de Dermatologie, Centre Hospitalier Metz-Thionville, Paris, France

family: Truchetet

full_name: François Truchetet

name: Service de Médecine Infectieuse, Centre Hospitalier Manchester, Charleville-Mézières, Paris, France

family: Galempoix

full_name: Jean-Marie Galempoix

given: Jean-Marie

name: Département d’Infectiologie, Centre Hospitalier Universitaire de Dijon, Paris, France

family: Piroth

full_name: Lionel Piroth

given: Lionel

name: Groupe d’étude sur le Risque d’exposition des Soignants aux Agents Infectieux, Paris, France

family: Pellissier

full_name: Gérard Pellissier

given: Gérard

name: Laboratoire de pharmacologie clinique, INSERM, Hôpital Jean Minjoz, Besançon, France

family: Muret

full_name: Patrice Muret

given: Patrice

name: Le Trait d’Union, HIV-Infection Care Center, Hôpitaux Universitaires de Strasbourg, France

family: Rey

full_name: David Rey

given: David

journal_name: Clinical Infectious Diseases

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Elvitegravir–Cobicistat–Emtricitabine–Tenofovir Alafenamide Single-tablet Regimen for Human Immunodeficiency Virus Postexposure Prophylaxis

lead_sponsor: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

location_facility:
Hôpital Saint-André
GH Pitié Salpetriere
CHU Ambroise Paré
Hôpital Croix Rousse
CHU de Reims
CHR de Metz
CHU Bichat
Hôpital Tenon
Hôpital de Tourcoing
Hôpital Jean Minjoz
CHU Dijon
Hôpitaux Universitaires
Hôpital Foch
Hôpital Saint-Antoine
CHU
Hôpital Manchester


lead_sponsor: University Hospital, Toulouse

primary_purpose: Supportive Care

acronym: STAR

location_facility:
Clermont-Ferrand Hospital
Brest University Hospital
Limoges Hospital
Pasteur Hospital
Orléans Hospital
Lyon Sud Hopsital
Saint-Etienne Hospital
Bicêtre Hospital
Strasbourg Hospital
Cochin Hospital
Jean Rougier Hospital
Lille Hospital
Montpellier Hospital
Hospital Pierre-Paul Riquet
Bordeaux University Hospital
Bichat Hospital
La Pitié-Salpétrière

type: Other Grant/Funding Number

title: Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission.

summary: The purpose of this study is to compare the proportion of patients who could withdraw from prednisone and hydrocortisone one year after a progressive decrease of GC (GC tapering) or a hydrocortisone replacement therapy in rheumatoid arthritis in remission or low disease activity.


title: A Phase 2 BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer

acronym: BIONIKK

summary:
Disease and Stage: naïve metastatic kidney cancer.

A multicenter, randomized, a Phase 2 BIOmarker driven trial with Nivolumab and Ipilimumab or VEGFR tKi in naïve metastatic Kidney cancer

ReferenceCitation: Epaillard N, Simonaggio A, Elaidi R, Azzouz F, Braychenko E, Thibault C, Sun CM, Moreira M, Oudard S, Vano YA. BIONIKK: A phase 2 biomarker driven trial with nivolumab and ipilimumab or VEGFR tyrosine kinase inhibitor (TKI) in naïve metastatic kidney cancer. Bull Cancer. 2020 Jun;107(5S):eS22-eS27. doi: 10.1016/S0007-4551(20)30283-6.

family: Epaillard

full_name: Nicolas Epaillard

given: Nicolas

family: Simonaggio

full_name: Audrey Simonaggio

given: Audrey

family: Elaidi

full_name: Reza Elaidi

given: Reza

family: Azzouz

full_name: Fouzia Azzouz

given: Fouzia

family: Braychenko

full_name: Elena Braychenko

given: Elena

family: Thibault

full_name: Constance Thibault

given: Constance

family: Sun

full_name: Cheng-Ming Sun

given: Cheng-Ming

family: Moreira

full_name: Marco Moreira

given: Marco

family: Oudard

full_name: Stéphane Oudard

given: Stéphane

family: Vano

full_name: Yann-Alexandre Vano

given: Yann-Alexandre

journal_name: Bulletin du Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_facility: Institut de Cancérologie du Gard - CHU Caremeau

location_facility: Centre Hospitalier Lyon Sud - Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL)


title: Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE

summary:
Patients are treated with infusions of Tocilizumab (TCZ) or placebo for 5 months. Clinical evaluation is performed using PMR-AS.

The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST) [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).

All the patients included are treated with glucocorticoid (GC).GC are reduced at each visit until the end of the study, depending on response to treatment and PMR-AS.

location_facility: Hopital Nord service de rhumatologie-Franche Comté


title: Cost-utility Evaluation of Two Strategies of Perineal Reconstruction After Abdominoperineal Resection for Anorectal Carcinoma: Perineal Filling With Biological Meshes vs. Primary Perineal Wound Closure

summary: Abdominoperineal resection performed for anorectal tumors leaves a large pelvic and perineal defect causing a high rate of morbidity of the perineal wound (40 - 60 %). Biological meshes offer possibility for a new standard of perineal wound reconstruction. Perineal filling with biological mesh is expected to increase quality of life by reducing perineal morbidity.

ReferenceCitation: Buscail E, Canivet C, Ghouti L, Kirzin S, Carrere N, Molinier L, Rosillo A, Lauwers-Cances V, Costa N; French Research Group of Rectal Cancer Surgery (GRECCAR Group). Randomised clinical trial for the cost-utility evaluation of two strategies of perineal reconstruction after abdominoperineal resection in the context of anorectal carcinoma: biological mesh repair versus primary perineal wound closure, study protocol for the GRECCAR 9 Study. BMJ Open. 2021 Apr 1;11(4):e043333. doi: 10.1136/bmjopen-2020-043333.

family: Buscail

full_name: Etienne Buscail

given: Etienne

family: Canivet

full_name: Cindy Canivet

given: Cindy

family: Ghouti

full_name: Laurent Ghouti

given: Laurent

family: Kirzin

full_name: Sylvain Kirzin

given: Sylvain

family: Carrere

full_name: Nicolas Carrere

family: Molinier

full_name: Laurent Molinier

family: Rosillo

full_name: Aline Rosillo

given: Aline

family: Lauwers-Cances

full_name: Valerie Lauwers-Cances

given: Valerie

family: Costa

full_name: Nadège Costa

given: Nadège

title: Randomised clinical trial for the cost–utility evaluation of two strategies of perineal reconstruction after abdominoperineal resection in the context of anorectal carcinoma: biological mesh repair versus primary perineal wound closure, study protocol for the GRECCAR 9 Study

location_facility:
CHRU Lille
Lyon University Hospital
Clermont-Ferrand University Hospital
Centre Oscar Lambret
Besançon University Hospital
Paoli Calmettes Institut
Saint-Antoine Hospital
Grenoble University Hospital
Nancy University Hospital
Rouen University Hospital
Institut de Cancérologie de Lorraine
Amiens University Hospital
University Hospital of Toulouse
Caen University Hospital
Angers University Hospital
Nantes University Hospital
Bordeaux University Hospital


title: Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma: Establishment of a Prospective Observational Cohort and Followed 3 Years

acronym: CAC-CBC

summary: Assessment of the concordance of the initial clinical and histological diagnosis and to explore its prognostic impact in terms of risk of recurrence.

lead_sponsor: University Hospital, Bordeaux

location_facility: University Hospital of Bordeaux - Hospital Saint André

location_facility: Tranchand (Dermatologue - Le Puy En Velay)

location_facility: Groupe Hospitalier de L'Institut Catholique de Lille


title: Biological and Clinical Database for Pancreatic Adenocarcinoma

acronym: BACAP

summary:
BACAP is a biobank dedicated to the pancreatic adenocarcinoma funded by institut national institue du cancer (INCa) and coordinated by Dr Barbara Bournet from Toulouse hospital. This base includes clinical data and biological samples such as blood, serum, plasma, saliva, DNA and RNA from tumors cells.

The mission of this prospective project is to make available to the scientific community a clinical biological base from patients with pancreatic adenocarcinoma

ReferenceCitation: Maulat C, Canivet C, Touraine C, Gourgou S, Napoleon B, Palazzo L, Flori N, Piessen G, Guibert P, Truant S, Assenat E, Buscail L, Bournet B, Muscari F, The Bacap Consortium. A New Score to Predict the Resectability of Pancreatic Adenocarcinoma: The BACAP Score. Cancers (Basel). 2020 Mar 25;12(4). pii: E783. doi: 10.3390/cancers12040783.

family: Maulat

full_name: Charlotte Maulat

given: Charlotte

family: Touraine

full_name: Célia Touraine

given: Célia

family: Gourgou

full_name: Sophie Gourgou

given: Sophie

family: Napoleon

full_name: Bertrand Napoleon

given: Bertrand

family: Palazzo

full_name: Laurent Palazzo

family: Flori

full_name: Nicolas Flori

given: Nicolas

family: Piessen

full_name: Guillaume Piessen

given: Guillaume

family: Guibert

full_name: Pierre Guibert

given: Pierre

family: Truant

full_name: Stéphanie Truant

given: Stéphanie

family: Assenat

full_name: Eric Assenat

given: Eric

full_name: Louis Buscail

given: Louis

family: Bournet

full_name: Barbara Bournet

given: Barbara

family: Muscari

full_name: Fabrice Muscari

given: Fabrice

name: the BACAP Consortium the BACAP Consortium

currency_apc_doaj: CHF

journal_name: Cancers

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

repository_normalized: HAL

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

repository_institution: Université de Lille (University Of Lille) - LillOA

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

ReferenceCitation: Frere C, Bournet B, Gourgou S, Fraisse J, Canivet C, Connors JM, Buscail L, Farge D; BACAP Consortium. Incidence of Venous Thromboembolism in Patients With Newly Diagnosed Pancreatic Cancer and Factors Associated With Outcomes. Gastroenterology. 2020 Apr;158(5):1346-1358.e4. doi: 10.1053/j.gastro.2019.12.009. Epub 2019 Dec 14.

ReferenceCitation: Canivet C, Gourgou-Bourgade S, Napoléon B, Palazzo L, Flori N, Guibert P, Piessen G, Farges-Bancel D, Seitz JF, Assenat E, Vendrely V, Truant S, Vanbiervliet G, Berthelémy P, Garcia S, Gomez-Brouchet A, Buscail L, Bournet B; BACAP Consortium. A prospective clinical and biological database for pancreatic adenocarcinoma: the BACAP cohort. BMC Cancer. 2018 Oct 16;18(1):986. doi: 10.1186/s12885-018-4906-4.

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

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

location_facility: Institut Regional du Cancer de Montpellier


lead_sponsor: UNICANCER

location_facility:
Centre Alexis Vautrin
Institut Gustave Roussy
Diaconesses - Croix St Simon
Hopital Henri Mondor
Centre Hospitalier Lyon Sud
Institut Cancerologie de La Loire
Hopital Saint Andre
Hopitaux Universitaires
Institut Claudius Regaud
Pitie Salpetriere
Institut Paoli Calmettes
Institut Curie
Centre Leon Berard
Centre Rene Gauducheau
Centre Francois Baclesse
Chu de Nimes
Institut Bergonie

ipd_sharing: Yes

title: Intensified Methotrexate, Vinblastine, Doxorubicin and Cisplatin +/-Panitumumab as First-line Treatment of Advanced Urothelial Carcinoma in Patients Without Harvey Nor Kirsten Rat Sarcoma Viral Oncogene Homolog Mutations. Phase II Study

summary:
OBJECTIVES OF THE TRIAL

Primary objective

Evaluation of efficacy in terms of progression-free survival at 9 months of the combination of intensified methotrexate, vinblastine, doxorubicin and cisplatin with or without panitumumab as first-line treatment of advanced urothelial carcinoma in patients without Harvey nor Kirsten rat sarcoma viral oncogene homolog mutations.

Secondary objectives

To assess toxicity
To assess response rate
To assess overall survival
To assess time to progression
To study the correlation between response rate, time to progression, overall survival and biological parameters


title: DIFFICULT PERIPHERAL INTRAVENOUS ACCESS IN ADULT DURING THE PREOPERATIVE PERIOD

acronym: VENSCORE

summary:
The objective of the prospective multicenter observational study consists in defining a difficult intravenous access score in adult, during the preoperative period.

The main objective: the outcome of interest is defined as failure of cannulation on first attempt.

The risk factors of failure of cannulation on first attempt will be described. Adjusted multivariate models will be constructed. A prediction model will be proposed according to the transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD)

location_facility: Centre hospitalier Universitaire de Bordeaux

location_facility: Hôpital d'instruction des Armées Robert Picqué


title: Phase II Study Evaluating the Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years Old With a Metastatic Colorectal Adenocarcinoma .

acronym: REGOLD

summary: Multicenter prospective phase II study evaluating regorafenib in older patients with metastatic colorectal cancer

ReferenceType: result

ReferenceCitation: Aparicio T, Darut-Jouve A, Khemissa Akouz F, Montérymard C, Artru P, Cany L, Romano O, Valenza B, Le Foll C, Delbaldo C, Falandry C, Norguet Monnereau E, Ben Abdelghani M, Smith D, Rinaldi Y, Père Verge D, Baize N, Maillard E, Dohan A, Des Guetz G, Pamoukdjian F, Lepage C. Single-arm phase II trial to evaluate efficacy and tolerance of regorafenib monotherapy in patients over 70 with previously treated metastatic colorectal adenocarcinoma FFCD 1404 - REGOLD. J Geriatr Oncol. 2020 Nov;11(8):1255-1262. doi: 10.1016/j.jgo.2020.04.001. Epub 2020 Apr 22.

family: Aparicio

full_name: Thomas Aparicio

given: Thomas

family: Darut-Jouve

full_name: Ariane Darut-Jouve

given: Ariane

family: Khemissa Akouz

full_name: Faiza Khemissa Akouz

given: Faiza

family: Montérymard

full_name: Carole Montérymard

given: Carole

family: Artru

full_name: Pascal Artru

given: Pascal

family: Cany

full_name: Laurent Cany

given: Laurent

family: Romano

full_name: Olivier Romano

given: Olivier

family: Valenza

full_name: Bruno Valenza

given: Bruno

family: Le Foll

full_name: Christine Le Foll

given: Christine

family: Delbaldo

full_name: Catherine Delbaldo

given: Catherine

family: Falandry

full_name: Claire Falandry

given: Claire

family: Norguet Monnereau

full_name: Emmanuelle Norguet Monnereau

given: Emmanuelle

family: Ben Abdelghani

full_name: Meher Ben Abdelghani

given: Meher

family: Smith

full_name: Denis Smith

given: Denis

family: Rinaldi

full_name: Yves Rinaldi

given: Yves

family: Père Verge

full_name: Denis Père Verge

family: Baize

full_name: Nathalie Baize

given: Nathalie

family: Maillard

full_name: Emmanuel Maillard

given: Emmanuel

family: Dohan

full_name: Anthony Dohan

given: Anthony

family: Des Guetz

full_name: Gaetan Des Guetz

given: Gaetan

family: Pamoukdjian

full_name: Frédéric Pamoukdjian

given: Frédéric

family: Lepage

full_name: Come Lepage

given: Come

title: Single-arm phase II trial to evaluate efficacy and tolerance of regorafenib monotherapy in patients over 70 with previously treated metastatic colorectal adenocarcinoma FFCD 1404 – REGOLD

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Caluire et Cuire - Infirmerie Protestante de Lyon


intervention_type: Device

lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronym: BISPHOO

location_facility: Hôpital ROGER SALENGRO - Radiologie et imagerie musculo-squelettique

location_facility: Hôpital LARIBOSISIERE - Service rhumatologie

location_facility: Hôpital LARIBOSISIERE - Service radiologie ostéo-articulaire

location_facility: Hopital PELLEGRIN - Service rhumatologie

location_facility: Hôpital LAPEYRONIE - Service Rhumatologie

location_facility: Hopital PELLEGRIN - Service d'imagerie diagnostique et interventionnelle de l'adulte

location_facility: Hôpital ROGER SALENGRO - Service d'Orthopédie A

title: Non-inferiority Trial of Three Cycles of Zoledronic Acid Versus Percutaneous Thermal Ablation in Osteoid Osteoma

summary: Osteoid osteoma (OO) is a benign osteogenic tumor occurring in children and young adults, responsible for intense bone pain, which has a tendency to spontaneously heal with mineralization of the nidus, but extremely slowly. This healing may be accelerated in patients taking NSAIDs regularly during a few years. The long delay for healing and intense pain, explain why patients are quickly directed to surgeons or specialized radiology departments for tumor ablation. But percutaneous treatment or surgical excision destruction can expose the patient to a substantial risk in terms of neurologic or joint damages, depending on the location. Bisphosphonates treatment may be an effective alternative to percutaneous treatment by accelerating the natural history of OO.


title: Multicentre, Prospective, Randomized, Open-label Study Comparing the Efficacy and Safety of CellCept With Delayed Introduction of Sirolimus and Discontinuation of Cyclosporine, With Those of Standard Immunosuppression Comprising CellCept and Long-term Continuation of Cyclosporine in Renal Transplant Recipients Receiving Induction by Zenapax and Treated With Corticosteroids for 8 Months

summary: This multicentre, prospective, randomized, open-label study will compare the safety and efficacy of mycophenolate mofetil with delayed introduction of sirolimus and discontinuation of cyclosporine, with those of mycophenolate mofetil and long term continuation of cyclosporine in renal transplant recipients receiving daclizumab (Zenapax) as induction treatment and followed by 8 month treatment with corticosteroids. The anticipated time on study treatment is 12 months. Participants who will complete the initial 12-month study and who will provide written informed consent will be eligible to participate in a 60-month follow-up phase.


lead_sponsor: University Hospital, Lille

acronym: VISMONEO

location_facility:
Hôpital Haut-Lévêque
CHU Ambroise Paré
Hôpital Bichat
Hôpital Pontchaillou
Hôpital Saint-Louis
Hôpital de la Timone
Centre hospitalier Lyon Sud
Hôpital Robert Debré
Hôpital Saint Eloi
Hôpital St André
Clinique de Dermatologie
Hôpitaux de Brabois
CHU - Hôpital d'Estaing
Institut Gustave Roussy
CHU Bocage
CH de Boulogne sur mer
CHU de Besançon

title: Phase II Study Evaluating the Interest of Vismodegib as Neo-adjuvant Treatment of Basal Cell Carcinoma (BCC)

summary: Open-label, non-comparative, multicenter, phase II study of Vismodegib in patients with locally advanced BCC.


title: Treatment of Chronic Subdural Hematoma by Corticosteroids

acronym: SUCRE

summary: Chronic subdural hematomas are a frequent neurosurgical pathology in the elderly. Gold standard is surgical evacuation of these hematomas. Physiopathology of chronic subdural hematoma involves numerous inflammatory processes which could be inhibited by steroids.

ReferenceCitation: Henaux PL, Le Reste PJ, Laviolle B, Morandi X. Steroids in chronic subdural hematomas (SUCRE trial): study protocol for a randomized controlled trial. Trials. 2017 Jun 5;18(1):252. doi: 10.1186/s13063-017-1990-8.

apc_source: openAPC

family: Henaux

full_name: Pierre-Louis Henaux

given: Pierre-Louis

family: Le Reste

full_name: Pierre-Jean Le Reste

given: Pierre-Jean

family: Laviolle

full_name: Bruno Laviolle

family: Morandi

full_name: Xavier Morandi

given: Xavier

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

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

repositories:
HAL
PubMed Central

location_facility:
CHU Angers
CHU Strasbourg
HC Lyon
CHU Poitiers
CHU Caen
CHU Amiens
CHU Saint Etienne
CHU Tours
CHU Bordeaux Neurochirurgie B
CHU Besançon
CHU Lille
CHU Nantes
CHU Nancy
CHU Rouen
CHU Brest
CHU Bordeaux Neurochirurgie A
AP-HM - Hôpital La Timone


title: EVRIOS : Comparative Evaluation of Low Versus High Doses of Rifampicin in the Treatment of Staphylococcal Bone and Joint Infections

acronym: EVRIOS

summary:
Rifampicin is an antibiotic usually required to treat susceptible Staphylococcus spp. osteo-articular infections, most frequently in association with a fluoroquinolone when the strain is susceptible to both agents. It is the reference treatment for orthopedic infections with implanted material.

For tuberculosis treatment the dosage of 10 mg/kg/j is usually prescribed, while in the treatment of Staphylococcus spp. infections the highest dosage of 20 mg/kg/j is proposed by French experts' recommendations from 2009.

However, there is little evidence in the literature, which could set out arguments to choose the best dosage of rifampicin, which may vary from 5 to 20 mg/kg.

The issue with rifampicin is side effects, in particular with long-term treatment. Many side effects may occur in 10 to 20% of patients and sometimes leads to dosage reduction or treatment interruption.

In the literature, there is little evidence that higher rifampicin dosage is associated with higher frequency of adverse effects. Depending on the nature of the toxicity, one could say that hypersensitivity could be independent from dosage, when digestive disorders may be related. Plasmatic concentrations studies have not given strong arguments to link higher rifampicin dosages with side effects occurrence rates. After oral absorption, plasmatic peak occurs after two to five hours and varies among individuals but also in the same patient overtime. This particular pharmacokinetic profile could explain discrepancy in adverse events (AEs) frequencies.

location_facility:
La Roche sur Yon hospital
Saint-Brieuc hospital
Brest university hospital
Caen university hospital
Vannes hospital
Rennes university hospital
Lorient hospital
Pau hospital
Bordeaux university hospital
Toulouse university hospital
Angers university hospital
Clinique du Parc et Hôpital Jean Mermoz
Poitiers university hospital
Tours university hospital
Saint-Malo hospital
Nantes university hospital


ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

acronym: IPSI-PSO

title: A 52-week (Plus Extension Until Commercialization), Single-arm Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI) at 16 Weeks, as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Participants Suffering From Moderate to Severe Psoriasis

summary: Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety, tolerability and efficacy of secukinumab administered subcutaneously during 52 weeks (plus extension) in patients with moderate to severe psoriasis.


lead_sponsor: Centre Francois Baclesse

location_facility: ICL Institut de Cancérologie de Lorraine

title: A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer

summary: ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer.


title: Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema

acronym: TRIOZ

summary:
Corticosteroids, whether injected peri- or intra-ocularly, remain indispensable tools of the therapeutic arsenal in treating inflammatory macular edema. However, a few years ago, only triamcinolone acetonide was available to ophthalmologists. This molecule, developed initially for rheumatological or dermatological use, has been increasingly deployed in ophthalmology, while still off-label.

In 2011, the delivery system of dexamethasone from biodegradable and injectable implant into the vitreous cavity obtained the label for inflammatory macular edema. This protocol is therefore designed to compare the efficacy and safety of peri- and intra-ocular injections of corticosteroids in the treatment of inflammatory macular edema.

ReferenceCitation: Couret C, Poinas A, Volteau C, Riche VP, Le Lez ML, Errera MH, Creuzot-Garcher C, Baillif S, Kodjikian L, Ivan C, Le Jumeau de Kergaradec LM, Chiffoleau A, Jobert A, Jaulin J, Biron L, Hervouet E, Weber M. Comparison of two techniques used in routine care for the treatment of inflammatory macular oedema, subconjunctival triamcinolone injection and intravitreal dexamethasone implant: medical and economic importance of this randomized controlled trial. Trials. 2020 Feb 10;21(1):159. doi: 10.1186/s13063-020-4066-0.

family: Couret

full_name: Chloé Couret

given: Chloé

family: Poinas

full_name: Alexandra Poinas

given: Alexandra

family: Volteau

full_name: Christelle Volteau

given: Christelle

family: Riche

full_name: Valery-Pierre Riche

given: Valery-Pierre

family: Le Lez

full_name: Marie-Laure Le Lez

given: Marie-Laure

family: Errera

full_name: Marie-Hélène Errera

given: Marie-Hélène

family: Creuzot-Garcher

full_name: Catherine Creuzot-Garcher

family: Baillif

full_name: Stéphanie Baillif

given: Stéphanie

family: Kodjikian

full_name: Laurent Kodjikian

given: Laurent

family: Ivan

full_name: Catherine Ivan

family: Le Jumeau de Kergaradec

full_name: Laurence Mathilde Le Jumeau de Kergaradec

given: Laurence Mathilde

family: Chiffoleau

full_name: Anne Chiffoleau

given: Anne

family: Jobert

full_name: Alexandra Jobert

family: Jaulin

full_name: Julie Jaulin

given: Julie

family: Biron

full_name: Laetitia Biron

given: Laetitia

family: Hervouet

full_name: Elisabeth Hervouet

given: Elisabeth

family: Weber

full_name: Michel Weber

given: Michel

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

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

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts


title: Characterization of Sensory Neuropathies Associated With Anti-FGFR3 Antibodies

summary:
Sensory neuronopathies affect sensory neuron in the posterior spinal ganglion. They are responsible for pain, balance disorder (ataxia) and the use of hands. They depend on multiple etiologies. In a retrospective study, the investigators showed that the anti-FGFR3 antibody is a diagnostic marker of a subset of sensory neuronopathies. The investigators believe that other antibodies can be discovered in patients who remain seronegative changing.

However, the study is retrospective and only a small number of patients could be identified. Several points therefore need to be clarified or confirmed in a second prospective study.

ReferenceCitation: Tholance Y, Moritz CP, Rosier C, Ferraud K, Lassablière F, Reynaud-Federspiel E, França MC Jr, Martinez ARM, Camdessanché JP, Antoine JC; anti-FGFR3 antibody Study Group. Clinical characterisation of sensory neuropathy with anti-FGFR3 autoantibodies. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):49-57. doi: 10.1136/jnnp-2019-321849. Epub 2019 Nov 5.

family: Tholance

full_name: Yannick Tholance

given: Yannick

family: Moritz

full_name: Christian Peter Moritz

given: Christian Peter

family: Rosier

full_name: Carole Rosier

given: Carole

family: Ferraud

full_name: Karine Ferraud

given: Karine

family: Lassablière

full_name: François Lassablière

given: François

family: Reynaud-Federspiel

full_name: Evelyne Reynaud-Federspiel

given: Evelyne

family: França Jr

full_name: Marcondes C França Jr

given: Marcondes C

family: Martinez

full_name: Alberto R M Martinez

given: Alberto R M

family: Camdessanché

full_name: Jean-Philippe Camdessanché

given: Jean-Philippe

family: Antoine

full_name: Jean-Christophe Antoine

given: Jean-Christophe

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

oa_host_type: repository

repository_institution: University of Southampton - ePrints Soton

version: acceptedVersion

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
AP-HM
CHRU de Nantes
Hospices Civils de Lyon
CHU de Limoges
Hôpital BICETRE
Hopital Pitie Salpetriere
Fondation Rothschild
CHU Poitiers
CHU Clermont-Ferrand
Chu Strasbourg
CHU de Grenoble
CHU Bordeaux
Chu Saint-Etienne
CH Cornouailles
CH Saint Denis - Hôpital Delafontaine
Chu Creteil
CHU de NICE


lead_sponsor: Center Eugene Marquis

acronym: CONVERCE

location_facility:
Hôîtal St louis
Centre Eugène Marquis
Hôpital Henri Mondor
CHRU Lille
CHU Ambroise Paré
CHU de Dijon
CHU de Nantes
Hôpital Bichat
CHU de Bordeaux
Centre Hospitalier du Mans
Centre Hospitalier Lyon Sud
CHU Caen - Hôpital Clémenceau
Hôpital Cochin
CHU Tours
CHU Brest - Hôpital Morvan
Groupe Hospitalier l'Archet
CHU Albert Michallon

title: Evaluation of Cobimetinib + Vemurafenib Combination Treatment in Patients With Brain Metastasis BRAFV600 Mutated Cutaneous Melanoma

summary: The purpose of this study is to determine wether cobimetinib + vemurafenib combination treatment is effective in the treatment of BRAFV600-mutated melanoma patients with brain metastasis


title: Renal Arteries Dysplastic Aneurysms: Anatomopathological and Genetic Study

summary:
Fibromuscular dysplasia (FMD) is localized structural defects in the arterial wall, whose innate or acquired character is still unknown. This segmental non atheromatous injury, leads to stenosis of the arteries of small and medium caliber. Renal arteries are the most commonly affected with 60-75% of total fibrodysplasia. Three histological subtypes have been described: intimal, medial and peri-medial. They are not mutually exclusive and can be observed in the same patient.

This is a rare blood disease, occurring in children and young adults. In this young population with long life expectancy, these aneurysmal lesion are associated with 10% risk of rupture. To date, no data have shown in the literature that FMD is link to genetic causes, or if there is specific histopathologic lesions for non-atherosclerotic renal artery aneurysms.

To answer these questions, Cardiovascular Surgery Unit of the University Hospital of Saint-Etienne, French national reference center for renal artery surgery, in association with the Reference Center for Rare Vascular Disease in Paris, designed the first study for pathological and genetic characteristics of dysplastic renal artery aneurysms in young patients.

location_facility:
Clinique Saint-Germain
CH Louis Pasteur
Hôpital Jeanne de Flandre
CH Henri Mondor
Hôpital Lapeyronie
Hôpital de la mère et de l'enfant
Groupe Hospitalier Pellegrin
Centre Hospitalier A. Gayraud
Hôpital Gabriel Montpied
Hôpital Robert Schuman
CH W. Morey
CHU Nantes
CH Emile Roux
Hôpital Européen Georges Pompidou
CHRU Tours
CHU Saint-Jacques
CH Niort


title: Multicentre Randomized Cross-over Study Assessing in Type 1 Diabetic Patients With Pump Insulin the Non-inferiority of Glycemic Control Obtained With the Algorithms Tested in DIABRASPORT Versus the Rest Period Without Physical Activity

summary:
There is no specific recommendations on the adjustments of the insulin treatment in the event of physical activity (PA) in T1D patients treated on insulin pump therapy. Patients often prefer additional carbohydrates intake rather than the reduction of their insulin doses because of the lack of specific algorithms.

The DIABRASPORT 2 study aims to demonstrate that using algorithms DIABRASPORT, during a week of physical activity (PA), the incidence of hypoglycaemia is not different from that obtained during a week of rest without physical activity.

It is a multi-center European, controlled, randomized, cross-over, study, in 100 T1D patients practicing an occasional AP.

25 centers involved in this study.

After agreeing to participate in the study, patients will read the information leaflet, ask questions to the investigator physician and they will date and sign the consent form. The investigator physician will do the same.

They will be then drawn randomly via the electronic CRF (eCRF) to determine the order in which they will realize the rest vs DIABRASPORT sessions.

The study will take place in 5 weeks:

During the weeks Baseline and Diabrasport, patients will have to make 3 physical activity of 30 to 60 minutes separated by at least 24 hours:

moderate activity 3 hours after lunch
intense activity 3 hours after lunch
activity moderate 90 min after lunch They will use their usual algorithms (Cho intake or adjustment of the dose of insulin) during the week Baseline and they will use the Diabrasport algorithm during the week Diabrasport.

Patients will be equipped with a holter Glycemic iPro2, Medtronic, whose data are hidden.

During the week of rest, patients should do no physical activity during the week. They will be equipped with the Glycemic holter.

Patients will have to fill a food survey the days they practice PA. Between each period, the patient must respect a period of wash-out for one week at least, during which he will be asked to not practice physical activity.

Validation of algorithms simple, easy to implement, adaptable by patients, could help to improve balance metabolic and practice of sport among the T1D.

primary_purpose: Basic Science

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility: Centre Hospitalier Régional Universitaire


title: A Dose-finding Phase I/II Trial of Daunorubicin and Cytarabine Combined to Fractionated Mylotarg® as Re-induction Treatment in Patients With First Relapse of Acute Myeloid Leukemia

summary: For several years, the effective standard induction chemotherapy for AML has been limited to the association of anthracycline and aracytine. GO is the first effective targeted antibody used in leukemia patients. In a previous study, we showed efficacy and safety of fractionated doses of GO used as a single agent for treatment of adult AML patients in first relapse. In the present study the possibility of combining fractionated doses of GO to escalated doses of a 3+7 regimen old is studied in relapsed AML patients > 50 and <70 years.

lead_sponsor: Acute Leukemia French Association

location_facility:
CH
Hopital Avicenne
Hopital Edouard Herriot
CNLCC
Hopital Saint-Louis
St Antoine Hospital
CHU
Hopital Percy
IGR


ReferenceCitation: Bachet JB, Hammel P, Desramé J, Meurisse A, Chibaudel B, André T, Debourdeau P, Dauba J, Lecomte T, Seitz JF, Tournigand C, Aparicio T, Meyer VG, Taieb J, Volet J, Monier A, Bonnetain F, Louvet C. Nab-paclitaxel plus either gemcitabine or simplified leucovorin and fluorouracil as first-line therapy for metastatic pancreatic adenocarcinoma (AFUGEM GERCOR): a non-comparative, multicentre, open-label, randomised phase 2 trial. Lancet Gastroenterol Hepatol. 2017 May;2(5):337-346. doi: 10.1016/S2468-1253(17)30046-8. Epub 2017 Feb 28.

family: Bachet

full_name: Jean-Baptiste Bachet

given: Jean-Baptiste

family: Hammel

full_name: Pascal Hammel

given: Pascal

family: Desramé

full_name: Jérôme Desramé

given: Jérôme

family: Meurisse

full_name: Aurélia Meurisse

given: Aurélia

family: Chibaudel

full_name: Benoist Chibaudel

given: Benoist

family: André

full_name: Thierry André

given: Thierry

family: Debourdeau

full_name: Philippe Debourdeau

given: Philippe

family: Dauba

full_name: Jérome Dauba

given: Jérome

family: Lecomte

full_name: Thierry Lecomte

family: Seitz

full_name: Jean-François Seitz

given: Jean-François

family: Tournigand

full_name: Christophe Tournigand

given: Christophe

family: Aparicio

full_name: Thomas Aparicio

given: Thomas

family: Meyer

full_name: Véronique Guerin Meyer

given: Véronique Guerin

family: Taieb

full_name: Julien Taieb

given: Julien

family: Volet

full_name: Julien Volet

family: Monier

full_name: Amandine Monier

given: Amandine

family: Bonnetain

full_name: Franck Bonnetain

given: Franck

family: Louvet

full_name: Christophe Louvet

journal_name: The Lancet Gastroenterology & Hepatology

ReferenceCitation: Bachet JB, Chibaudel B, Bonnetain F, Validire P, Hammel P, André T, Louvet C; GERCOR group. A randomized phase II study of weekly nab-paclitaxel plus gemcitabine or simplified LV5FU2 as first-line therapy in patients with metastatic pancreatic cancer: the AFUGEM GERCOR trial. BMC Cancer. 2015 Oct 6;15:653. doi: 10.1186/s12885-015-1656-4.

family: Validire

full_name: Pierre Validire

given: Pierre

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

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Institut de cancérologie de l'Ouest - Paul Papin

location_facility: Institut de Cancérologie de l'Ouest - Réné Gauducheau

title: Randomized Phase II Study of Weekly ABI-007 Plus Gemcitabine or Simplified LV5FU2 as First-line Therapy in Patients With Metastatic Pancreatic Cancer

summary: To evaluate the combination of ABI-007 with gemcitabine or with LV5FU2.


ReferenceCitation: Bachet JB, Blons H, Hammel P, Hariry IE, Portales F, Mineur L, Metges JP, Mulot C, Bourreau C, Cain J, Cros J, Laurent-Puig P. Circulating Tumor DNA is Prognostic and Potentially Predictive of Eryaspase Efficacy in Second-line in Patients with Advanced Pancreatic Adenocarcinoma. Clin Cancer Res. 2020 Oct 1;26(19):5208-5216. doi: 10.1158/1078-0432.CCR-20-0950. Epub 2020 Jun 30.

family: Bachet

full_name: Jean-Baptiste Bachet

family: Blons

full_name: Hélène Blons

given: Hélène

family: Hammel

full_name: Pascal Hammel

family: Hariry

full_name: Iman El Hariry

given: Iman El

family: Portales

full_name: Fabienne Portales

given: Fabienne

family: Mineur

full_name: Laurent Mineur

given: Laurent

family: Metges

full_name: Jean-Philippe Metges

given: Jean-Philippe

family: Mulot

full_name: Claire Mulot

given: Claire

family: Bourreau

full_name: Camille Bourreau

given: Camille

family: Cain

full_name: Jason Cain

given: Jason

family: Cros

full_name: Jérôme Cros

family: Laurent-Puig

full_name: Pierre Laurent-Puig

journal_name: Clinical Cancer Research

version: submittedVersion

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

publisher: American Association for Cancer Research (AACR)

ReferenceCitation: Hammel P, Fabienne P, Mineur L, Metges JP, Andre T, De La Fouchardiere C, Louvet C, El Hajbi F, Faroux R, Guimbaud R, Tougeron D, Bouche O, Lecomte T, Rebischung C, Tournigand C, Cros J, Kay R, Hamm A, Gupta A, Bachet JB, El Hariry I. Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial. Eur J Cancer. 2020 Jan;124:91-101. doi: 10.1016/j.ejca.2019.10.020. Epub 2019 Nov 21. Erratum in: Eur J Cancer. 2020 May;130:275-276.

family: Fabienne

full_name: Portales Fabienne

given: Portales

family: Andre

full_name: Thierry Andre

family: De La Fouchardiere

full_name: Christelle De La Fouchardiere

given: Christelle

family: El Hajbi

full_name: Farid El Hajbi

given: Farid

family: Faroux

full_name: Roger Faroux

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

location_facility: Institut Regional du Cancer-Montpellier Val d'Aurelle

location_facility: Centre Hospitalier Departemental Vendee - Les Oudairies

title: Phase II, Randomized, Controlled, Clinical Trial Exploring Efficacy and Safety of ERY001 (L-asparaginase Encapsulated in Red Blood Cells) in Association With Gemcitabine or FOLFOX4 in Second-line Therapy for Patients With Progressive Metastatic Pancreatic Carcinoma

summary:
A new approach that aims to destroy pancreatic tumor cells through modification of the tumor environment.

Asparagine synthetase (ASNS) is an enzyme wich synthetise asparagine. Asparagine is an essential nutriment for pancreatic cancer cells which have no or low level of ASNS.

by L-asparaginase encapsulated in erythrocytes deplete (supress) Plasma asparagine.

in selected patients having no or low ASNS, may provide a new therapeutic approach.


ReferenceCitation: François B, Cariou A, Clere-Jehl R, Dequin PF, Renon-Carron F, Daix T, Guitton C, Deye N, Legriel S, Plantefève G, Quenot JP, Desachy A, Kamel T, Bedon-Carte S, Diehl JL, Chudeau N, Karam E, Durand-Zaleski I, Giraudeau B, Vignon P, Le Gouge A; CRICS-TRIGGERSEP Network and the ANTHARTIC Study Group. Prevention of Early Ventilator-Associated Pneumonia after Cardiac Arrest. N Engl J Med. 2019 Nov 7;381(19):1831-1842. doi: 10.1056/NEJMoa1812379.

name: From Réanimation Polyvalente (B.F., T.D., P.V.), INSERM Centre d’Investigation Clinique (CIC) 1435 (B.F., T.D., P.V.), and Unité des Essais Cliniques, Pharmacie à Usage Intérieur (F.R.-C.), Centre Hospitalier Universitaire (CHU) Dupuytren, and INSERM Unité Mixte de Recherche (UMR) 1092, Faculté de Médecine, Université de Limoges (B.F., T.D., P.V.), Limoges, Médecine Intensive et Réanimation, Hôpitaux Universitaires Paris Centre (site Cochin), Assistance Publique–Hôpitaux de Paris (AP-HP) (A.C.),...

family: François

full_name: Bruno François

given: Bruno

family: Cariou

full_name: Alain Cariou

given: Alain

family: Clere-Jehl

full_name: Raphaël Clere-Jehl

given: Raphaël

family: Dequin

full_name: Pierre-François Dequin

given: Pierre-François

family: Renon-Carron

full_name: Françoise Renon-Carron

given: Françoise

family: Daix

full_name: Thomas Daix

given: Thomas

family: Guitton

full_name: Christophe Guitton

given: Christophe

family: Deye

full_name: Nicolas Deye

given: Nicolas

family: Legriel

full_name: Stéphane Legriel

given: Stéphane

family: Plantefève

full_name: Gaëtan Plantefève

given: Gaëtan

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Desachy

full_name: Arnaud Desachy

given: Arnaud

family: Kamel

full_name: Toufik Kamel

given: Toufik

family: Bedon-Carte

full_name: Sandrine Bedon-Carte

given: Sandrine

family: Diehl

full_name: Jean-Luc Diehl

given: Jean-Luc

family: Chudeau

full_name: Nicolas Chudeau

family: Karam

full_name: Elias Karam

given: Elias

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

given: Isabelle

family: Giraudeau

full_name: Bruno Giraudeau

family: Vignon

full_name: Philippe Vignon

given: Philippe

family: Le Gouge

full_name: Amélie Le Gouge

given: Amélie

journal_name: New England Journal of Medicine

evidence: open (via free article)

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

location_facility: AP-HP - Hôpital Européen Georges Pompidou - Service de Réanimation

location_facility: CHU de Limoges - Service de réanimation polyvalente

location_facility: AP-HP - Hôpital Lariboisière - Service de Réanimation

location_facility: AP-HP - Hôpital Cochin - Service de Réanimation

location_facility: CH Brive La Gaillarde - Service de Réanimation

location_facility: AP-HP - Hôpital pointcaré - Service de Réanimation

title: Prevention of Early Ventilator-associated Pneumonia With Antibiotic Therapy in Patients Treated With Mild Therapeutic Hypothermia After Cardiac Arrest.

summary:
Mild therapeutic hypothermia is currently recommended in management of cardiac arrests with shockable rhythm. In mechanically ventilated patients who were resuscitated after out-of-hospital cardiac arrests, mild therapeutic hypothermia side effects are conductive for infectious complications and especially for ventilator-associated pneumonia (VAP).

Despite high incidence of VAP and other infectious complications, it is not currently recommended to use antibiotic prophylaxis on the responsible germs. Yet VAP incidence could be decreased if an antibiotic therapy was systematically given to patient treated with mild therapeutic hypothermia after a cardiac arrest. Several retrospective studies showed less infectious complications but also decreased morbidity and mortality related to these complications when antibiotic therapy was given early to patients treated with therapeutic hypothermia after cardiac arrest.


title: Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer

summary:
Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for patients with unresectable pancreatic cancer.

Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such population

ReferenceCitation: Neuzillet C, Vergnault M, Bonnetain F, Hammel P. Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Coopérateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:454. doi: 10.1186/s13063-015-0983-8.

family: Neuzillet

full_name: Cindy Neuzillet

given: Cindy

family: Vergnault

full_name: Mathieu Vergnault

given: Mathieu

family: Bonnetain

full_name: Franck Bonnetain

given: Franck

family: Hammel

full_name: Pascal Hammel

given: Pascal

location_facility:
CH Mont de Marsan
Hôpital Henri Mondor
Centre Léon Bérard
Institut de cancérologie de Lorraine
Hôpital Saint Antoine
Centre Hospitalier de Belfort
CHU Robert Debré
Hôpital Européen
Centre Georges François Leclerc
Institut Hospitalier Franco-Britannique
Hôpital Cochin
CHU Morvan
CHD Vendée
CH Saint Joseph Saint Luc
Hôpital FOCH
Polyclinique Bordeaux Nord Aquitaine
Hôpital Beaujon


title: Phase I-II on Radiochemotherapy Combined With Panitumumab in the Treatment of Localised Epidermoid Carcinoma of the Anus

summary:
Treatment is based on radiochemotherapy for locally advanced tumours. The objective of treatment is to provide a cure without resorting to abdominoperineal amputation, while preserving sphincter function.

The prognosis is mainly related to tumour size and lymph node invasion. The large majority of patients do not show any spread remote from the tumour at the time of diagnosis (2).

Recurrences are mainly of a local/regional nature and require abdominoperineal amputation. This type of intervention is not always possible or complete, which then gives rise to the particularly distressing risk of local progression, with survival at 3 years of approximately 30% (3).

It is therefore very important to achieve a complete and permanent tumour response from initial treatment with radiochemotherapy.

Furthermore, the use of an anti-EGFR antibody in combination with exclusive radiotherapy in ENT cancer was able to increase recurrence-free survival and overall survival in these patients. These data are in favour of the use of a combination of chemotherapy and anti-EGFR antibodies in epidermoid cancer of the anus.

ReferenceCitation: Vendrely V, Lemanski C, Gnep K, Barbier E, Hajbi FE, Lledo G, Dahan L, Terrebonne E, Manfredi S, Mirabel X, Mammar V, Cowen D, Lepage C, Aparicio T; for FFCD investigators/Collaborators. Anti-epidermal growth factor receptor therapy in combination with chemoradiotherapy for the treatment of locally advanced anal canal carcinoma: Results of a phase I dose-escalation study with panitumumab (FFCD 0904). Radiother Oncol. 2019 Nov;140:84-89. doi: 10.1016/j.radonc.2019.05.018. Epub 2019 Jun 8.

family: Vendrely

full_name: Véronique Vendrely

given: Véronique

family: Lemanski

full_name: Claire Lemanski

given: Claire

family: Gnep

full_name: Khemara Gnep

given: Khemara

family: Barbier

full_name: Emilie Barbier

given: Emilie

family: Hajbi

full_name: Farid El Hajbi

given: Farid El

family: Lledo

full_name: Gerard Lledo

given: Gerard

family: Dahan

full_name: Laëtitia Dahan

given: Laëtitia

family: Terrebonne

full_name: Eric Terrebonne

given: Eric

family: Manfredi

full_name: Sylvain Manfredi

given: Sylvain

family: Mirabel

full_name: Xavier Mirabel

given: Xavier

family: Mammar

full_name: Vincent Mammar

given: Vincent

family: Cowen

full_name: Didier Cowen

given: Didier

family: Lepage

full_name: Come Lepage

given: Come

family: Aparicio

full_name: Thomas Aparicio

given: Thomas

journal_name: Radiotherapy and Oncology

location_facility: Centre d'oncologie et de radiothérapie du Parc

location_facility: Cario - HPCA - Hôpital privé des Côtes D'Armor


title: Phase 2 Study of a Reduced-toxicity Myeloablative Conditionning Regimen Using Fludarabine and Full Doses of iv Busulfan in Pediatric Patients Not Eligible for Standard Myeloablative Conditioning Regimens

summary: The purpose of this study is to assess transplant-related mortality (TRM) at one year after allogeneic hematopoietic stem cell transplantation (allo-HSCT) prepared by a "reduced toxicity myeloablative" conditioning regimen in young patients (children and adolescents) with hematologic malignancies.

lead_sponsor: Nantes University Hospital

location_facility:
University Hospital
University Hopsital


title: Prevention of Atrial Fibrillation by Combined Right Isthmus Ablation and cryoBalloon Pulmonary Vein Isolation in Patients With Typical Atrial Flutter

acronym: PAF CRIOBLAF

summary:
- Background:

Atrial fibrillation is frequently associated with typical atrial flutter in clinical practice. If the radical treatment of atrial flutter by radiofrequency catheter is achieved in most cases without recurrence, it does not prevent the occurrence of atrial fibrillation that occurs in about 70% of these patients after several years of follow-up. However, the latter arrhythmia is associated with significant morbidity and mortality. The problem of atrial fibrillation occurrence after successful ablation of typical atrial flutter remains physicians primary concern in monitoring these patients.

Objectives:

The purpose of this study is to demonstrate that the pulmonary veins isolation using balloon cryotherapy technology performed at the time of flutter ablation, significantly reduces the risk of developing atrial fibrillation in the two year period following the procedure.

Selection Criteria:

Patients referred for ablation of typical atrial flutter with an history of at least one documented episode of atrial fibrillation (atrial flutter remaining the predominant arrhythmia)will be enrolled in the study.

Study Methods:

This is a prospective, multicenter, randomized, 2-arms study, comparing the rate of atrial fibrillation occurrence over a two years period following either an ablation procedure of typical atrial flutter (Group 1), or a combined procedure of typical atrial flutter ablation and pulmonary veins cryoballoon isolation (Group 2). The enrollment period will be of 18 months.

Randomization will be 1:1 and will be balanced in blocks of varying size. Patients will then be regularly followed up clinically and by long-term ECG recordings.

Evaluation Criteria:

The primary endpoint will be the recurrence of symptomatic or asymptomatic atrial fibrillation, documented by an ECG or an R-test, occurring between M3 and M24

Number of patients:

170 patients will be enrolled in the study

Number of centers:

Four French and three German centers will participate.

Perspective:

The demonstration of a clinical benefit in terms of atrial fibrillation risk reduction in the patient group with pulmonary vein isolation, could lead to a modification of atrial arrhythmia treatment indication.

lead_sponsor: University Hospital, Rouen

location_facility:
Nouvelles Cliniques Nantaises
Clinique Saint Gatien
CHU de Nantes
Hôpital Privé de Clairval
CHU de Strasbourg
Clinique Saint Joseph
Polyclinique Vauban
University Hospital of Rouen
CHU de Tours
Clinique Pasteur
CHU Grenoble
AP-HM - Hôpital Nord
CHU de Brest
CH La Rochelle
CHU de Rennes


title: Sensitivity of ADHD-IV Rating Scale in the Evaluation of the Evolution of Attention Disorders Associated With Childhood Epilepsy : a Validation Study

summary:
The cognitive and psychiatric comorbidities are crucial endpoints in epileptic patients. Among these comorbidities, the Attention-Deficit Hyperactivity Disorder (ADHD) accounts for one of the most important in terms of frequency and psychosocial and educational consequences.

In these conditions, our study was designed to estimate the sensitivity to changes of the different sub-scores of the ADHD rating Scale IV (ADHD RS IV) in epileptic patient. This will then optimize our methodological approach for a therapeutic trial.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Neurologie Pédiatrique, CHU de Tours

location_facility: Service de Neurologie Pédiatrique, CHU d'Angers

location_facility: Service de Neurologie pédiatrique, Hôpital Neckert-Enfants malades

location_facility: Service de Neurologie Pédiatrique, Hôpital des Enfants

location_facility: Service d'épileptologie pédiatrique, CHR de Chambéry

location_facility: Unité de Neurologie de l'Enfant et de l'Adolescent, Hôpital Pellegrin

location_facility: Service de Neurologie pédiatrique, CHU d'Amiens

location_facility: Service de Neurologie pédiatrique, CHU de Besançon

location_facility: Service de Neurologie pédiatrique, Hôpital de la Timone

location_facility: Institut des Epilepsies de l'Enfant et de l'Adolescent, Hôpital Femme Mère Enfant

location_facility: Centre Référent des Epilepsies Rares, Hôpital de Hautepierre

location_facility: Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique Pierre Wertheimer

location_facility: Service de Neurologie Pédiatrique, Hôpital Robert-Debré


title: Medico-economic Evaluation Comparing Conformal Radiotherapy With Intensity Modulation (IMRT) Performed by, Helical Tomotherapy (Hi Art) and Dynamic Arc Therapy (RapidArc, VMAT) in Cancers With Pelvic Lymph Node Irradiation (Prostate, Cervix, Anal Canal)

acronym: RCMI PELVIS

summary: The aim of the study is a medico-economic evaluation to estimate a cost differential between three modalities of Intensity-Modulated Radiation Therapy for cancers of the prostate, cervix and anal canal with pelvic lymph node irradiation : treatment with helical Tomotherapy and dynamic arc therapy using two different technologies: RapidArc or VMAT.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Assistance publique des Hôpitaux de Marseille


title: Comparative Efficacy of DuodartTM Versus Watchful Waiting With Step-up Therapy to Tamsulosin in the Management of Treatment naïve Men With Symptomatic BPH

acronym: CONDUCT

summary:
Study FDC114615 is a two year, multi-centre, randomised, open-label trial to assess the efficacy of Dutasteride plus tamsulosin when compared to the standard practice of watchful waiting, with a defined escalation to tamsulosin in treatment naive men with symptomatic benign prostate hyperplasia (BPH).

Once consented, each subject will undergo screening procedures to ensure the prostate volume and post void residual are within eligible range. If all entry criteria are met, subjects will be randomised (1:1) to receive Dutasteride plus tamsulosin with lifestyle advice or watchful waiting, with lifestyle advice, with a defined escalation to tamsulosin. Escalation will be initiated when no improvement from baseline is scored using the International Prostate Symptom Score (version 2) (IPSS) questionnaire.

After randomisation, the subjects return to site at one month, then every 13 weeks until two years of treatment is complete or they are withdrawn. Key assessments, such as Adverse Events (AE's) and concomitant medication monitoring and completion of the quality of life questionnaires are performed at each visit and the data recorded.

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

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Netherlands
France
Greece
Romania
Spain
Germany
United Kingdom