title: Prevention of Venous Thromboembolism Disease for Acutelly Ill Medical Patients Admitted to Hospital : Systematic Analysis of Thrombosis Risk Factors and Remember of Prevention Treatment Indications in Emergency Departments.

acronym: PREVENU

summary:
The appropriate use of thromboprophylaxis in medical patients admitted to hospital can substantially reduce the overall burden of disease due to venous thromboembolism. However, the use of thromboprophylaxis in medical setting appears to be generally poor leaving at-risk patients unprotected.

We aim to analyse the incidence of symptomatic thromboembolic disease following hospitalisation in medical setting and the efficacy of a multicomponent prevention approach in emergency department including systematic evaluation of thrombosis risk factors and remembers of thrombophylaxis indications and modalities for acutely ill medical patients.

Design: cluster randomized interventional study - Observational study at patient level

Setting: 30 French emergency departments

Patients: Patients over 40 years old admitted in participating emergency departments and hospitalized for acute medical reasons.

Main judgment criteria: the rate of symptomatic thromboembolic events and severe haemorrhage during a formal 3-months follow-up after hospital admission in patients hospitalized at least 48 hours.

ReferenceCitation: Roy PM, Rachas A, Meyer G, Le Gal G, Durieux P, El Kouri D, Honnart D, Schmidt J, Legall C, Hausfater P, Chrétien JM, Mottier D; PREVENU study group. Multifaceted Intervention to Prevent Venous Thromboembolism in Patients Hospitalized for Acute Medical Illness: A Multicenter Cluster-Randomized Trial. PLoS One. 2016 May 26;11(5):e0154832. doi: 10.1371/journal.pone.0154832. eCollection 2016.

family: Roy

full_name: Pierre-Marie Roy

given: Pierre-Marie

family: Rachas

full_name: Antoine Rachas

given: Antoine

family: Meyer

full_name: Guy Meyer

given: Guy

family: Le Gal

full_name: Grégoire Le Gal

given: Grégoire

family: Durieux

full_name: Pierre Durieux

given: Pierre

family: El Kouri

full_name: Dominique El Kouri

given: Dominique

family: Honnart

full_name: Didier Honnart

given: Didier

family: Schmidt

full_name: Jeannot Schmidt

given: Jeannot

family: Legall

full_name: Catherine Legall

given: Catherine

family: Hausfater

full_name: Pierre Hausfater

family: Chrétien

full_name: Jean-Marie Chrétien

given: Jean-Marie

family: Mottier

full_name: Dominique Mottier

currency_apc_doaj: USD

journal_name: PLOS ONE

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Jean Moulin Lyon 3

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Audencia Business School

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

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

location_facility:
UH Agen
H Compiegne
UH La Reunion
UH Rennes
UH Bichat
UH Besançon
H Bethune
UH Dijon
UH Nantes
UH Nimes
H Argenteuil
UH la pitié salpetriere
UH Hotel Dieu
UH Poitiers
H Clermont Ferrand
UH Marseille
UH Grenoble
UH Ambroise Pare
H Bobigny
UH Brest
UH Metz Thionville
H Cochin
H Chateauroux


title: Safety and Efficacy of a Strategy of Allogeneic Hematopoietic Stem Cell Transplantation After Reduced-intensity Conditioning for Chemosensitive Relapsed Follicular Lymphoma

acronym: RITALLO

summary: This trial will evaluate the efficacy and the safety of a strategy of allogeneic stem cell transplantation including Rituximab in the conditioning regimen for the treatment of relapsed follicular lymphoma. The rationale for using Rituximab relies on a better control of the disease and a better prophylaxis of the graft versus host disease.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. Epub 2007 Jan 22.

ReferenceCitation: Khouri IF, Saliba RM, Giralt SA, Lee MS, Okoroji GJ, Hagemeister FB, Korbling M, Younes A, Ippoliti C, Gajewski JL, McLaughlin P, Anderlini P, Donato ML, Cabanillas FF, Champlin RE. Nonablative allogeneic hematopoietic transplantation as adoptive immunotherapy for indolent lymphoma: low incidence of toxicity, acute graft-versus-host disease, and treatment-related mortality. Blood. 2001 Dec 15;98(13):3595-9.

ReferenceCitation: Khouri IF, McLaughlin P, Saliba RM, Hosing C, Korbling M, Lee MS, Medeiros LJ, Fayad L, Samaniego F, Alousi A, Anderlini P, Couriel D, de Lima M, Giralt S, Neelapu SS, Ueno NT, Samuels BI, Hagemeister F, Kwak LW, Champlin RE. Eight-year experience with allogeneic stem cell transplantation for relapsed follicular lymphoma after nonmyeloablative conditioning with fludarabine, cyclophosphamide, and rituximab. Blood. 2008 Jun 15;111(12):5530-6. doi: 10.1182/blood-2008-01-136242. Epub 2008 Apr 14. Erratum in: Blood. 2009 Feb 12;113(7):1613.

ReferenceCitation: Vigouroux S, Michallet M, Porcher R, Attal M, Ades L, Bernard M, Blaise D, Tabrizi R, Garban F, Cassuto JP, Chevalier P, Facon T, Ifrah N, Renaud M, Tilly H, Vernant JP, Kuentz M, Bourhis JH, Bordigoni P, Deconinck E, Lioure B, Socié G, Milpied N; French Society of Bone Marrow Graft Transplantation and Cellular Therapy (SFGM-TC). Long-term outcomes after reduced-intensity conditioning allogeneic stem cell transplantation for low-grade lymphoma: a survey by the French Society of Bone Marrow Graft Transplantation and Cellular Therapy (SFGM-TC). Haematologica. 2007 May;92(5):627-34.

ReferenceCitation: Christopeit M, Schütte V, Theurich S, Weber T, Grothe W, Behre G. Rituximab reduces the incidence of acute graft-versus-host disease. Blood. 2009 Mar 26;113(13):3130-1. doi: 10.1182/blood-2009-01-200527.

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

location_facility: Service des maladies du sang - Hôpital Haut-Lévêque - avenue de magellan

location_facility: Service Hématologie Clinique, Hôpital Archet 1

location_facility: Service Hématologie et Thérapie cellulaire, Pavillon Villemin Pasteur, CHU Clermont-Ferrand

location_facility: Service Hématologie Oncologie, Hôpital Lapeyronie, CHU de Montpellier

location_facility: Service Hématologie, Hôpital Augustin Morvan

location_facility: Département d'Hématologie et d'Oncologie, Hôpital CHRU de Hautepierre

location_facility: Service Hématologie Clinique, Hôpital Pontchaillou

location_facility: Service Hématologie Clinique, CHU -Hôtel Dieu

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


intervention_type: Procedure

lead_sponsor: University Hospital, Limoges

primary_purpose: Diagnostic

acronym: FUO-TEP

location_facility: Service des Isotopes - CRLCC Centre Eugène Marquis

location_facility: Médecine Interne - AP-HP - Hôpital Hôtel Dieu

location_facility: Département de Médecine pour adulte - CHU

location_facility: Médecine Interne - AP-HP - La Pitié Salpétrière

location_facility: Médecine Interne - AP-HP - Hôpital Bichat

location_facility: Médecine Nucléaire - AP-HP - La Pitié Salpétrière

location_facility: Médecine Nucléaire - AP-HP - Hôpital Bichat

location_facility: Médecine Nucléaire - AP-HP - Hôpital Hôtel Dieu

location_facility: Médecine Nucléaire et Imagerie Fonctionnelle - CHU

location_facility: Médecine Interne - AP-HP - Hôpital Cochin

source: euctr

title: Impact of the PET-scan in the Diagnosis Strategy of Fever Unknown Origin or Inflammatory Syndrome in Immunocompetent Patients

summary: Fever of unknown origin (FUO) and chronic inflammatory syndrome could be seen in many affections. The diagnostic process is still a challenge and could not be specified yet after several clinical studies performed by trained teams using two levels diagnostic procedures. For this reason, the diagnosis involves many additional and expensive tests such as computed tomography (CT scan), scintigraphic imaging, endoscopy, biopsy. There is no evidence-based recommendation for the diagnostic work-up of FUO or chronic inflammatory syndrome. Positron emission tomography with 2-[18F] fluoro-2-deoxy-D-glucose combined with CT scan (FDG-PET/CT) is widely used in malignant diseases and seems to be promising for the diagnosis of inflammatory disorders. Its role has not been yet clearly defined in the investigation of FUO and chronic inflammatory syndrome.


title: One-year Mortality According to the Method of Total Intravenous Anesthesia. A Prospective, Randomized and Multicenter Study

acronym: ELA

summary:
A correlation between deep anesthesia (defined as time with Bispectral Index (BIS) lower than 45) and death within 1 yr after surgery has previously been reported. In order to confirm or refute these findings, the investigators have designed a study which compares two methods of administration for total intravenous anesthesia (propofol and remifentanil):

manual administration: the anesthesiologists are instructed to maintain the BIS value between 40 and 60.
closed loop administration: an algorithm is used to maintain the BIS value between 40 and 60.

Based on previous studies, the amount of time that BIS is maintained above 40 is greater when anesthetics agents are administered using closed loop compared with manual administration.

design_allocation: Randomized

ReferenceCitation: Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95.

ReferenceCitation: Cantraine FR, Coussaert EJ. The first object oriented monitor for intravenous anesthesia. J Clin Monit Comput. 2000 Jan;16(1):3-10.

ReferenceType: result

ReferenceCitation: Lindholm ML, Träff S, Granath F, Greenwald SD, Ekbom A, Lennmarken C, Sandin RH. Mortality within 2 years after surgery in relation to low intraoperative bispectral index values and preexisting malignant disease. Anesth Analg. 2009 Feb;108(2):508-12. doi: 10.1213/ane.0b013e31818f603c.

family: Lindholm

full_name: Maj-Lis Lindholm

given: Maj-Lis

sequence: first

family: Träff

full_name: Stefan Träff

given: Stefan

sequence: additional

family: Granath

full_name: Fredrik Granath

given: Fredrik

family: Greenwald

full_name: Scott D. Greenwald

given: Scott D.

family: Ekbom

full_name: Anders Ekbom

given: Anders

family: Lennmarken

full_name: Claes Lennmarken

given: Claes

family: Sandin

full_name: Rolf H. Sandin

given: Rolf H.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Anesthesia & Analgesia

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Mortality Within 2 Years After Surgery in Relation to Low Intraoperative Bispectral Index Values and Preexisting Malignant Disease

ReferenceCitation: Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.

family: Monk

full_name: Terri G. Monk

given: Terri G.

family: Saini

full_name: Vikas Saini

given: Vikas

family: Weldon

full_name: B Craig Weldon

given: B Craig

family: Sigl

full_name: Jeffrey C. Sigl

given: Jeffrey C.

title: Anesthetic Management and One-Year Mortality After Noncardiac Surgery

ReferenceType: derived

ReferenceCitation: Mahr N, Bouhake Y, Chopard G, Liu N, Boichut N, Chazot T, Claveau M, Vettoretti L, Tio G, Pili-Floury S, Samain E, Besch G. Postoperative Neurocognitive Disorders After Closed-Loop Versus Manual Target Controlled-Infusion of Propofol and Remifentanil in Patients Undergoing Elective Major Noncardiac Surgery: The Randomized Controlled Postoperative Cognitive Dysfunction-Electroencephalographic-Guided Anesthetic Administration Trial. Anesth Analg. 2021 Oct 1;133(4):837-847. doi: 10.1213/ANE.0000000000005278.

family: Mahr

full_name: Nicolas Mahr

given: Nicolas

family: Bouhake

full_name: Yannis Bouhake

given: Yannis

family: Chopard

full_name: Gilles Chopard

given: Gilles

family: Liu

full_name: Ngai Liu

given: Ngai

family: Boichut

full_name: Nathalie Boichut

given: Nathalie

family: Chazot

full_name: Thierry Chazot

given: Thierry

family: Claveau

full_name: Melanie Claveau

given: Melanie

location_facility: Hôpitaux Universitaires Paris-Seine St Denis CHU Avicenne


title: A Phase 4, Observational Study to Explore How Different Treatment Regimens Affect Continuation With Treatment in the First 6 Months Following Initiation of XAGRID Into Adult Patients' Essential Thrombocythemia Therapy

acronym: FOX

summary: This is an observational study to explore how different treatment regimens affect continuation with treatment in the first 6 months following initiation of XAGRID into adult patients' essential thrombocythemia therapy.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Rey J, Viallard JF, Keddad K, Smith J, Wilde P, Kiladjian JJ; FOX study investigators. Characterization of different regimens for initiating anagrelide in patients with essential thrombocythemia who are intolerant or refractory to their current cytoreductive therapy: results from the multicenter FOX study of 177 patients in France. Eur J Haematol. 2014 Feb;92(2):127-36. doi: 10.1111/ejh.12210. Epub 2013 Nov 25.

name: Onco‐Hematology Department Institut Paoli‐Calmettes Marseille France

family: Rey

full_name: Jérôme Rey

given: Jérôme

name: Department of Internal Medicine Hôpital Haut Lévéque Pessac and University of Bordeaux 2 Bordeaux France

family: Viallard

full_name: Jean‐François Viallard

given: Jean‐François

name: Medical Affairs Department Shire France SA Boulogne Billancourt France

family: Keddad

full_name: Karim Keddad

given: Karim

name: Clinical Development Operations and Biometrics Shire Pharmaceuticals Development Ltd Basingstoke UK

family: Smith

full_name: Jonathan Smith

given: Jonathan

family: Wilde

full_name: Paul Wilde

given: Paul

name: AP‐HP Hôpital Saint‐Louis Centre d'Investigations Cliniques Paris France

name: Department of Pharmacology Université Paris Diderot Paris France

family: Kiladjian

full_name: Jean‐Jacques Kiladjian

given: Jean‐Jacques

name: on behalf of the FOX study investigators

journal_name: European Journal of Haematology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Characterization of different regimens for initiating anagrelide in patients with essential thrombocythemia who are intolerant or refractory to their current cytoreductive therapy: results from the multicenter FOX study of 177 patients in F rance

lead_sponsor: Shire

location_facility:
Hopital Saint Jean
Hopital N D Bon Secours
Hopital Henri Mondor
Hopital Dupuytren
CME
Clinique Du Parc
Ch D Arras
Hopital Hautepierre
CH Departemental Des Oudairies
Institut J Paoli Calmettes
CH De Bicetre
Hopital Hotel Dieu Et Hme
Polyclinique Bordeaux Nord Aquitaine
Hopitaux de Brabois
Ch De Brive La Gaillarde
Chi De Cornouaille
Hopital Emile Muller
Hopital De Haut Leveque
Hopital De L Archet
Hotel Dieu
Hopital Edouard Herriot
Hopital Saint Philibert
Ch De Vendome
CHU Nord - Chemin Des Bourrely
Hopital Robert Ballanger
Clinique Pont de Chaume
CHI Poissy Saint German en Laye
CHRU Lille - Hopital Huriez
Hia Sainte Anne
Hopital Robert Boulin
CHRA
Nouvelles Cliniques Nantaises
Centre De Radiotherapie
Hopital Saint Antoine
Hopital de La Maison Blanche
CH DU Pays D Aix
Hopital Augustin Morvan
Institut de Cancerologie de la Loire
CH De Blois
GH Pitie Salpetriere
Hopital Font Pre
Ch De Fleyriat
Hopital Pontchaillou
Cabinet D'Hematologie
Hopital Tenon

lead_sponsor_type: industriel


title: Randomized Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone to High-Dose Treatment With ASCT in the Initial Management of Myeloma in Patients up to 65 Years of Age

summary: Objective of this study is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs Progression-free survival (by at least 9 months).

ReferenceCitation: Samur MK, Aktas Samur A, Fulciniti M, Szalat R, Han T, Shammas M, Richardson P, Magrangeas F, Minvielle S, Corre J, Moreau P, Thakurta A, Anderson KC, Parmigiani G, Avet-Loiseau H, Munshi NC. Genome-Wide Somatic Alterations in Multiple Myeloma Reveal a Superior Outcome Group. J Clin Oncol. 2020 Sep 20;38(27):3107-3118. doi: 10.1200/JCO.20.00461. Epub 2020 Jul 20.

name: Department of Data Sciences, Dana Farber Cancer Institute, Boston, MA

name: Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA

name: Department of Medical Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA

family: Samur

full_name: Mehmet Kemal Samur

given: Mehmet Kemal

family: Aktas Samur

full_name: Anil Aktas Samur

given: Anil

family: Fulciniti

full_name: Mariateresa Fulciniti

given: Mariateresa

family: Szalat

full_name: Raphael Szalat

given: Raphael

family: Han

full_name: Tessa Han

given: Tessa

family: Shammas

full_name: Masood Shammas

given: Masood

family: Richardson

full_name: Paul Richardson

name: Inserm UMR892, CNRS 6299, Université de Nantes, and Centre Hospitalier Universitaire de Nantes, Unité Mixte de Genomique du Cancer, Nantes, France

family: Magrangeas

full_name: Florence Magrangeas

given: Florence

family: Minvielle

full_name: Stephane Minvielle

given: Stephane

name: University Cancer Center of Toulouse Institut National de la Santé, Toulouse, France

family: Corre

full_name: Jill Corre

given: Jill

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Thakurta

full_name: Anjan Thakurta

given: Anjan

family: Anderson

full_name: Kenneth C. Anderson

given: Kenneth C.

family: Parmigiani

full_name: Giovanni Parmigiani

given: Giovanni

family: Avet-Loiseau

full_name: Hervé Avet-Loiseau

given: Hervé

family: Munshi

full_name: Nikhil C. Munshi

given: Nikhil C.

journal_name: Journal of Clinical Oncology

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_normalized: HAL

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Roussel M, Hebraud B, Hulin C, Perrot A, Caillot D, Stoppa AM, Macro M, Escoffre M, Arnulf B, Belhadj K, Karlin L, Garderet L, Facon T, Guo S, Weng J, Dhanasiri S, Leleu X, Moreau P, Attal M. Health-related quality of life results from the IFM 2009 trial: treatment with lenalidomide, bortezomib, and dexamethasone in transplant-eligible patients with newly diagnosed multiple myeloma. Leuk Lymphoma. 2020 Jun;61(6):1323-1333. doi: 10.1080/10428194.2020.1719091. Epub 2020 Feb 22.

name: Institut Universitaire du Cancer de Toulouse-Oncopole and University Hospital, Toulouse, France;

name: CHU de Nancy, University of Lorraine, Nancy, France;

name: Hôpital du Bocage, CHU de Dijon, Dijon, France;

name: Hematologie clinique, Institut Paoli-Calmettes, Marseille, France;

name: Hôpital Côte de Nacre, CHU de Caen, Caen, France;

name: Hôpital Saint-Louis, AP-HP, Paris,  France;

name: Hématologie clinique, CHU de Lyon HCL – GH Sud, Pierre-Bénite, France;

name: Hôpital Pitié Salpétriere Saint-Antoine, AP-HP, Paris, France;

name: Hôpital Claude Huriez, CHRU de Lille, Lille, France;

name: Celgene International, A Bristol-Myers Squibb Company, Boudry, Switzerland;

name: Poitiers University Hospital, Poitiers, France;

name: Nantes University Hospital, Nantes, France

ReferenceCitation: Attal M, Lauwers-Cances V, Hulin C, Leleu X, Caillot D, Escoffre M, Arnulf B, Macro M, Belhadj K, Garderet L, Roussel M, Payen C, Mathiot C, Fermand JP, Meuleman N, Rollet S, Maglio ME, Zeytoonjian AA, Weller EA, Munshi N, Anderson KC, Richardson PG, Facon T, Avet-Loiseau H, Harousseau JL, Moreau P; IFM 2009 Study. Lenalidomide, Bortezomib, and Dexamethasone with Transplantation for Myeloma. N Engl J Med. 2017 Apr 6;376(14):1311-1320. doi: 10.1056/NEJMoa1611750.

ReferenceCitation: Dunavin NC, Wei L, Elder P, Phillips GS, Benson DM Jr, Hofmeister CC, Penza S, Greenfield C, Rose KS, Rieser G, Merritt L, Ketcham J, Heerema N, Byrd JC, Devine SM, Efebera YA. Early versus delayed autologous stem cell transplant in patients receiving novel therapies for multiple myeloma. Leuk Lymphoma. 2013 Aug;54(8):1658-64. doi: 10.3109/10428194.2012.751528. Epub 2012 Dec 31.

location_facility: Centre Hospitalier Argenteuil Victor Dupouy

location_facility: Centre Hospitalier Départemental - La réunion St Denis

location_facility: Centre Hospitalier de la région d'Annecy

location_facility: Centre hospitalier départemental - La Roche sur Yon cedex


type: Other Identifier

title: Phase IV Multicentric Study, 140 Patients Suffering of Meibomian Glands Dysfunction.

acronym: ESPOIR Ext

summary:
Multicentric study, open label, uncontrolled phase IV in 140 patients with meibomian glands dysfunction .

Its objective is to Collect information from patients and ophthalmologists specialized in ocular surface and eyelids to anticipate how Blephasteam ® can be optimized.

This study involves 2 visits, visit of Inclusion, J0, then end of study visit, D21.

Between the two visits patients will be treated with Blephasteam ® for 21 days (up to two uses per day) and complete a questionnaire every two days during the first week and then once a week the next two weeks.

lead_sponsor: Laboratoires Thea

location_facility: Hopital d'instruction des armées LAVERAN

intervention_type: Device


title: Radiotherapy - Anastrazole Concomitant : Evaluation of the Side Effects

acronym: ORACLES

summary: This study is a description of the radiation effects on the healthy tissues in patients receiving Anastrozole, sequential or in association with radiotherapy.

lead_sponsor: Centre Oscar Lambret

location_country: Monaco France

location_facility: Centre: Clinique Armoricaine de Radiologie


title: Observational Study on the Management of Patients With Non Small Cell Lung Cancer (NSCLC) Adenocarcinoma Tested for the Activating Mutation of Epidermal Growth Factor Receptor Tyrosine Kinase (EGFR TK)

acronym: MUTACT

summary: The main objective of the study is to determine the proportion of patients with M + mutation status among patients with Non Small Cell Lung Cancer adenocarcinoma.

lead_sponsor: AstraZeneca


title: A Double-Blind, Randomized, Phase II/III Study Comparing the Use of Chemoembolization Combined With Sunitinib Against Chemoembolization Combined With a Placebo in Patients With Hepatocellular Carcinoma (SATURNE)

acronym: SATURNE

summary:
RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping anticancer drugs near the tumor. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether chemoembolization is more effective with or without sunitinib malate in treating patients with liver cancer.

PURPOSE: This randomized phase II/III trial is studying the side effects of chemoembolization of the liver and to see how well in works when given together with or without sunitinib malate in treating patients with liver cancer.

ReferenceCitation: Turpin A, de Baere T, Heurgué A, Le Malicot K, Ollivier-Hourmand I, Lecomte T, Perrier H, Vergniol J, Sefrioui D, Rinaldi Y, Edeline J, Jouve JL, Silvain C, Becouarn Y, Dauvois B, Baconnier M, Debette-Gratien M, Deplanque G, Dharancy S, Lepage C, Hebbar M; PRODIGE 16 investigators Collaborators. Liver transarterial chemoembolization and sunitinib for unresectable hepatocellular carcinoma: Results of the PRODIGE 16 study. Clin Res Hepatol Gastroenterol. 2021 Mar;45(2):101464. doi: 10.1016/j.clinre.2020.05.012. Epub 2020 Jun 21.

family: Turpin

full_name: Anthony Turpin

given: Anthony

family: de Baere

full_name: Thierry de Baere

given: Thierry

family: Heurgué

full_name: Alexandra Heurgué

given: Alexandra

family: Le Malicot

full_name: Karine Le Malicot

given: Karine

family: Ollivier-Hourmand

full_name: Isabelle Ollivier-Hourmand

given: Isabelle

family: Lecomte

full_name: Thierry Lecomte

family: Perrier

full_name: Hervé Perrier

family: Vergniol

full_name: Julien Vergniol

given: Julien

family: Sefrioui

full_name: David Sefrioui

given: David

family: Rinaldi

full_name: Yves Rinaldi

given: Yves

family: Edeline

full_name: Julien Edeline

family: Jouve

full_name: Jean-Louis Jouve

given: Jean-Louis

family: Silvain

full_name: Christine Silvain

given: Christine

family: Becouarn

full_name: Yves Becouarn

family: Dauvois

full_name: Barbara Dauvois

given: Barbara

family: Baconnier

full_name: Mathieu Baconnier

given: Mathieu

family: Debette-Gratien

full_name: Maryline Debette-Gratien

given: Maryline

family: Deplanque

full_name: Gael Deplanque

given: Gael

family: Dharancy

full_name: Sébastien Dharancy

given: Sébastien

family: Lepage

full_name: Côme Lepage

given: Côme

family: Hebbar

full_name: Mohamed Hebbar

given: Mohamed

journal_name: Clinics and Research in Hepatology and Gastroenterology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
CHU Jean Bernard
CHBS
CHU La Timone
Hopital Dupuytren
CHU
CHU Bocage
Groupe Hospitalier Paris St Joseph
Hôpital Claude Huriez
CHU -Hôpital de l'Archet II
CH Conception
CHR
Hôpital Privé Jean Mermoz
CHU Côte de Nacre
CHU Robert Debré
CAC
CHRU Saint Eloi
Hôpital Saint Joseph
CHU Nord
Institut Bergonié
Institut Gustave Roussy
CH
CH Ambroise Paré
CHU J Minjoz
Institut Sainte Catherine
Hôpital Européen Georges Pompidou
Clinique des Cèdres
Hopital Tenon


status: Terminated

lead_sponsor: Grünenthal GmbH

location_facility:
Site 28
Site 31
Site 21
Site 35
Site 30
Site 15
Site 27
Site 23
Site 12
Site 24
Site 20
Site 33
Site 14
Site 36
Site 38
Site 19
Site 22
Site 18
Site 17
Site 34
Site 26
Site 39

type: EudraCT Number

title: Lidocaine 5% Medicated Plaster for the Topical Treatment of Localized Chronic Postoperative Neuropathic Pain.

summary: The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.

status_simplified: Unknown


ReferenceCitation: Coudert B, Pierga JY, Mouret-Reynier MA, Kerrou K, Ferrero JM, Petit T, Kerbrat P, Dupré PF, Bachelot T, Gabelle P, Giard S, Coeffic D, Bougnoux P, Prevost JB, Paintaud G, Thibault G, Hernandez J, Coudert M, Arnould L, Berriolo-Riedinger A. Use of [(18)F]-FDG PET to predict response to neoadjuvant trastuzumab and docetaxel in patients with HER2-positive breast cancer, and addition of bevacizumab to neoadjuvant trastuzumab and docetaxel in [(18)F]-FDG PET-predicted non-responders (AVATAXHER): an open-label, randomised phase 2 trial. Lancet Oncol. 2014 Dec;15(13):1493-1502. doi: 10.1016/S1470-2045(14)70475-9. Epub 2014 Oct 30.

family: Coudert

full_name: Bruno Coudert

given: Bruno

family: Pierga

full_name: Jean-Yves Pierga

given: Jean-Yves

family: Mouret-Reynier

full_name: Marie-Ange Mouret-Reynier

given: Marie-Ange

family: Kerrou

full_name: Kaldoun Kerrou

given: Kaldoun

family: Ferrero

full_name: Jean-Marc Ferrero

given: Jean-Marc

family: Petit

full_name: Thierry Petit

family: Kerbrat

full_name: Pierre Kerbrat

given: Pierre

family: Dupré

full_name: Pierre-François Dupré

given: Pierre-François

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Gabelle

full_name: Philippe Gabelle

given: Philippe

family: Giard

full_name: Sylvia Giard

given: Sylvia

family: Coeffic

full_name: David Coeffic

family: Bougnoux

full_name: Philippe Bougnoux

family: Prevost

full_name: Jean-Briac Prevost

given: Jean-Briac

family: Paintaud

full_name: Gilles Paintaud

given: Gilles

family: Thibault

full_name: Gilles Thibault

family: Hernandez

full_name: Juana Hernandez

given: Juana

full_name: Mathieu Coudert

family: Arnould

full_name: Laurent Arnould

given: Laurent

family: Berriolo-Riedinger

full_name: Alina Berriolo-Riedinger

given: Alina

journal_name: The Lancet Oncology

title: Use of [18F]-FDG PET to predict response to neoadjuvant trastuzumab and docetaxel in patients with HER2-positive breast cancer, and addition of bevacizumab to neoadjuvant trastuzumab and docetaxel in [18F]-FDG PET-predicted non-responders (AVATAXHER): an open-label, randomised phase 2 trial

intervention_type: Radiation

lead_sponsor: Hoffmann-La Roche

acronym: AVATAXHER

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Hopital Clinique Claude Bernard; Oncologie Medicale

location_facility: Institut de Cancerologie de La Loire; Radiotherapie

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Pole Sante Republique;Oncologie Hematologie

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: GH Paris Saint Joseph; Hopital De Jour Oncologie

location_facility: Ch De Montlucon; Sce Med Interne Hemato Onco

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Institut Jean Godinot; Oncologie Medicale

location_facility: Centre Henry S Kaplan - CHU Bretonneau ; service oncologie

title: An Open-Label, Randomized, Multicenter, Phase II, Non Comparative, Exploratory Study on Neoadjuvant Treatment With Trastuzumab Plus Docetaxel Plus Bevacizumab According to Positon Emission Tomography (PET) Value Modification in Patients With Early Stage HER2 Positive Breast Cancer

summary: This randomized study will assess the effect of adding bevacizumab to trastuzumab plus docetaxel in neoadjuvant therapy in participants with early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. After 2 cycles of trastuzumab and docetaxel once every 3 weeks, participants with a response (change in standard uptake value [SUV]) of less than (<) 70 percent (%) on Positron Emission Tomography (PET) will be randomized in a 2:1 ratio to receive Cycles 3 to 6 of trastuzumab (6 milligrams per kilogram [mg/kg]) and docetaxel (100 milligrams per square meter [mg/m^2]) with or without bevacizumab (15 mg/kg). Participants with a response of greater than or equal to (>/=) 70% will receive trastuzumab plus docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery (as per investigator's discretion) after Cycle 7 and between 4 and 6 weeks after the treatment perfusion of Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy (starting from 4-8 weeks after surgery during 4-6 weeks, according to site's standard practice) with or without hormonal therapy (mandatory if positive hormone receptors). Participants will be followed for up to 5 years from start of neoadjuvant treatment.


title: Observational Cohort Study on the Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA

summary: Observational cohort study on the prevention of venous thromboembolic events after elective orthopaedic surgery for Total Knee Replacement or Total Hip Replacement iin patients treated with PRADAXA to evaluate the efficacy ant safety of Pradaxa in real-life conditions

lead_sponsor: Boehringer Ingelheim

location_facility: Boehringer Ingelheim Investigational Site 18

location_facility: Boehringer Ingelheim Investigational Site 28

location_facility: Boehringer Ingelheim Investigational Site 20

location_facility: Boehringer Ingelheim Investigational Site 25

location_facility: Boehringer Ingelheim Investigational Site 48

location_facility: Boehringer Ingelheim Investigational Site 33

location_facility: Boehringer Ingelheim Investigational Site 42

location_facility: Boehringer Ingelheim Investigational Site 16

location_facility: Boehringer Ingelheim Investigational Site 36

location_facility: Boehringer Ingelheim Investigational Site 8

location_facility: Boehringer Ingelheim Investigational Site 39

location_facility: Boehringer Ingelheim Investigational Site 10

location_facility: Boehringer Ingelheim Investigational Site 22

location_facility: Boehringer Ingelheim Investigational Site 12

location_facility: Boehringer Ingelheim Investigational Site 38

location_facility: Boehringer Ingelheim Investigational Site 29

location_facility: Boehringer Ingelheim Investigational Site 32

location_facility: Boehringer Ingelheim Investigational Site 53

location_facility: Boehringer Ingelheim Investigational Site 11

location_facility: Boehringer Ingelheim Investigational Site 43

location_facility: Boehringer Ingelheim Investigational Site 14

location_facility: Boehringer Ingelheim Investigational Site 26

location_facility: Boehringer Ingelheim Investigational Site 40

location_facility: Boehringer Ingelheim Investigational Site 35

location_facility: Boehringer Ingelheim Investigational Site 24

location_facility: Boehringer Ingelheim Investigational Site 49

location_facility: Boehringer Ingelheim Investigational Site 52

location_facility: Boehringer Ingelheim Investigational Site 45

location_facility: Boehringer Ingelheim Investigational Site 47

location_facility: Boehringer Ingelheim Investigational Site 15

location_facility: Boehringer Ingelheim Investigational Site 7

location_facility: Boehringer Ingelheim Investigational Site 41

location_facility: Boehringer Ingelheim Investigational Site 30

location_facility: Boehringer Ingelheim Investigational Site 9

location_facility: Boehringer Ingelheim Investigational Site 23

location_facility: Boehringer Ingelheim Investigational Site 13

location_facility: Boehringer Ingelheim Investigational Site 46

location_facility: Boehringer Ingelheim Investigational Site 50

location_facility: Boehringer Ingelheim Investigational Site 27

location_facility: Boehringer Ingelheim Investigational Site 44

location_facility: Boehringer Ingelheim Investigational Site 31

location_facility: Boehringer Ingelheim Investigational Site 21

location_facility: Boehringer Ingelheim Investigational Site 51

location_facility: Boehringer Ingelheim Investigational Site 17

location_facility: Boehringer Ingelheim Investigational Site 37

location_facility: Boehringer Ingelheim Investigational Site 34

location_facility: Boehringer Ingelheim Investigational Site 19

location_facility: Boehringer Ingelheim Investigational Site 6


title: Breast Cancer Adjuvant Hormonotherapy : Tamoxifen and the Anti-aromatases Pharmacokinetics, Correlation With the Pharmacogenetic Characteristics PHACS Protocol : Pharmacology of Adjuvant Hormonotherapy in Breast Cancer

acronym: PHACS

summary:
This is a biomedical study of interventional type, multicenter, inter-regional.

Patients with hormono-depending breast cancer, for which an indication of adjuvant hormonotherapy treatment (according to the current treatments) was retained, will be enrolled in this study. The main objective is to estimate the correlations between pharmacokinetic and pharmacogenetic parameters of adjuvant hormonal breast cancer treatment, during the first 3 years.

ReferenceCitation: Puszkiel A, Arellano C, Vachoux C, Evrard A, Le Morvan V, Boyer JC, Robert J, Delmas C, Dalenc F, Debled M, Venat-Bouvet L, Jacot W, Dohollou N, Bernard-Marty C, Laharie-Mineur H, Filleron T, Roché H, Chatelut E, Thomas F, White-Koning M. Model-Based Quantification of Impact of Genetic Polymorphisms and Co-Medications on Pharmacokinetics of Tamoxifen and Six Metabolites in Breast Cancer. Clin Pharmacol Ther. 2021 May;109(5):1244-1255. doi: 10.1002/cpt.2077. Epub 2020 Nov 10.

name: Cancer Research Center of Toulouse (CRCT) Inserm U1037Université Paul Sabatier Toulouse France

family: Puszkiel

full_name: Alicja Puszkiel

given: Alicja

family: Arellano

full_name: Cécile Arellano

given: Cécile

family: Vachoux

full_name: Christelle Vachoux

given: Christelle

name: Laboratoire de Biochimie et Biologie Moléculaire Centre Hospitalier Universitaire Nîmes‐Carémeau Nîmes France

name: IRCM InsermUniversité de MontpellierICM Montpellier France

family: Evrard

full_name: Alexandre Evrard

given: Alexandre

name: Inserm U1218Université de Bordeaux Bordeaux France

family: Le Morvan

full_name: Valérie Le Morvan

given: Valérie

family: Boyer

full_name: Jean‐Christophe Boyer

given: Jean‐Christophe

family: Robert

full_name: Jacques Robert

given: Jacques

name: Institut Claudius RegaudInstitut Universitaire du Cancer de Toulouse – Oncopole Toulouse France

family: Delmas

full_name: Caroline Delmas

given: Caroline

family: Dalenc

full_name: Florence Dalenc

given: Florence

family: Debled

full_name: Marc Debled

given: Marc

name: Centre Hospitalier Universitaire Dupuytren Limoges France

family: Venat‐Bouvet

full_name: Laurence Venat‐Bouvet

given: Laurence

name: Institut du Cancer de Montpellier Montpellier France

family: Jacot

full_name: William Jacot

given: William

name: Polyclinique Bordeaux Nord Aquitaine Bordeaux France

family: Dohollou

full_name: Nadine Dohollou

given: Nadine

name: Clinique Pasteur – ONCORAD Toulouse France

family: Bernard‐Marty

full_name: Chantal Bernard‐Marty

given: Chantal

family: Laharie‐Mineur

full_name: Hortense Laharie‐Mineur

given: Hortense

family: Filleron

full_name: Thomas Filleron

family: Roché

full_name: Henri Roché

given: Henri

family: Chatelut

full_name: Etienne Chatelut

given: Etienne

family: Thomas

full_name: Fabienne Thomas

given: Fabienne

family: White‐Koning

full_name: Melanie White‐Koning

given: Melanie

bso_classification: Chemistry

journal_name: Clinical Pharmacology & Therapeutics

title: Model‐Based Quantification of Impact of Genetic Polymorphisms and Co‐Medications on Pharmacokinetics of Tamoxifen and Six Metabolites in Breast Cancer

lead_sponsor: Institut Claudius Regaud

location_facility: Clinique Pasteur - Département de Radiothérapie

location_facility: Centre Hospitalier Intercommunal de Castres-Mazamet

location_facility: Clinique Pasteur - Département d'Oncologie Médicale


title: A Comparative Study to Assess the Effect of Retreatment With 2 Doses of MabThera on Disease Activity Score in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to antiTNF-alfa Therapy.(SMART)

summary: This study will compare the efficacy and safety of re-treatment with 2 doses of MabThera (rituximab) in patients with active rheumatoid arthritis (RA) who have previously experienced an inadequate response or intolerance to anti-tumor necrosis factor (anti-TNF) therapies etanercept, infliximab or adalimumab therapy. All patients will receive infusions of 1000 mg intravenous (IV) MabThera on Days 1 and 15; at Week 24 patients who have demonstrated a moderate or good response will be randomized to receive re-treatment with either 1 or 2 additional infusions of 1000 mg IV MabThera. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

ReferenceCitation: de Jong TD, Sellam J, Agca R, Vosslamber S, Witte BI, Tsang-A-Sjoe M, Mantel E, Bijlsma JW, Voskuyl AE, Nurmohamed MT, Verweij CL, Mariette X. A multi-parameter response prediction model for rituximab in rheumatoid arthritis. Joint Bone Spine. 2018 Mar;85(2):219-226. doi: 10.1016/j.jbspin.2017.02.015. Epub 2017 Mar 28.

family: de Jong

full_name: Tamarah D. de Jong

given: Tamarah D.

family: Sellam

full_name: Jérémie Sellam

given: Jérémie

family: Agca

full_name: Rabia Agca

given: Rabia

family: Vosslamber

full_name: Saskia Vosslamber

given: Saskia

family: Witte

full_name: Birgit I. Witte

given: Birgit I.

family: Tsang-A-Sjoe

full_name: Michel Tsang-A-Sjoe

given: Michel

family: Mantel

full_name: Elise Mantel

given: Elise

family: Bijlsma

full_name: Johannes W. Bijlsma

given: Johannes W.

family: Voskuyl

full_name: Alexandre E. Voskuyl

given: Alexandre E.

family: Nurmohamed

full_name: Mike T. Nurmohamed

given: Mike T.

family: Verweij

full_name: Cornelis L. Verweij

given: Cornelis L.

family: Mariette

full_name: Xavier Mariette

given: Xavier

journal_name: Joint Bone Spine

ReferenceCitation: Sellam J, Rivière E, Courties A, Rouzaire PO, Tolusso B, Vital EM, Emery P, Ferraccioli G, Soubrier M, Ly B, Hendel Chavez H, Taoufik Y, Dougados M, Mariette X. Serum IL-33, a new marker predicting response to rituximab in rheumatoid arthritis. Arthritis Res Ther. 2016 Dec 13;18(1):294. Erratum in: Arthritis Res Ther. 2017 Jan 23;19(1):11.

ReferenceCitation: Sellam J, Rouanet S, Hendel-Chavez H, Miceli-Richard C, Combe B, Sibilia J, Le Loët X, Tebib J, Jourdan R, Dougados M, Taoufik Y, Mariette X. CCL19, a B cell chemokine, is related to the decrease of blood memory B cells and predicts the clinical response to rituximab in patients with rheumatoid arthritis. Arthritis Rheum. 2013 Sep;65(9):2253-61. doi: 10.1002/art.38023.

name: Hôpital Saint-Antoine, AP-HP, and Université Pierre et Marie Curie Paris 06; Paris France

family: Rouanet

full_name: Stéphanie Rouanet

given: Stéphanie

name: Bicêtre Hospital, AP-HP, and Université Paris-Sud 11; Le Kremlin Bicêtre France

family: Hendel-Chavez

full_name: Houria Hendel-Chavez

given: Houria

name: Université Paris-Sud 11, AP-HP, Hôpitaux Universitaires Paris-Sud, Hôpital de Bicêtre, and INSERM U1012; Le Kremlin Bicêtre France

family: Miceli-Richard

full_name: Corinne Miceli-Richard

given: Corinne

name: Lapeyronie University Hospital, Montpellier I University, and UMR5535; Montpellier France

family: Combe

full_name: Bernard Combe

given: Bernard

name: EA 3432, Hôpitaux Universitaires de Strasbourg, and Université de Strasbourg; Strasbourg France

family: Sibilia

full_name: Jean Sibilia

given: Jean

name: Rouen University Hospital and INSERM U905; Rouen France

family: Le Loët

full_name: Xavier Le Loët

name: Centre Hospitalier Lyon-Sud; Pierre-Bénite France

family: Tebib

full_name: Jacques Tebib

family: Jourdan

full_name: Rosemary Jourdan

name: Paris-Descartes University, UPRES-EA 4058, AP-HP, and Cochin Hospital; Paris France

title: CCL19, a B Cell Chemokine, Is Related to the Decrease of Blood Memory B Cells and Predicts the Clinical Response to Rituximab in Patients With Rheumatoid Arthritis

ReferenceCitation: Mariette X, Rouanet S, Sibilia J, Combe B, Le Loët X, Tebib J, Jourdan R, Dougados M. Evaluation of low-dose rituximab for the retreatment of patients with active rheumatoid arthritis: a non-inferiority randomised controlled trial. Ann Rheum Dis. 2014 Aug;73(8):1508-14. doi: 10.1136/annrheumdis-2013-203480. Epub 2013 May 30.

ReferenceCitation: Sellam J, Rouanet S, Hendel-Chavez H, Abbed K, Sibilia J, Tebib J, Le Loët X, Combe B, Dougados M, Mariette X, Taoufik Y. Blood memory B cells are disturbed and predict the response to rituximab in patients with rheumatoid arthritis. Arthritis Rheum. 2011 Dec;63(12):3692-701. doi: 10.1002/art.30599.

ReferenceCitation: Sellam J, Hendel-Chavez H, Rouanet S, Abbed K, Combe B, Le Loët X, Tebib J, Sibilia J, Taoufik Y, Dougados M, Mariette X. B cell activation biomarkers as predictive factors for the response to rituximab in rheumatoid arthritis: a six-month, national, multicenter, open-label study. Arthritis Rheum. 2011 Apr;63(4):933-8. doi: 10.1002/art.30233.

title: B cell activation biomarkers as predictive factors for the response to rituximab in rheumatoid arthritis: A six-month, national, multicenter, open-label study


title: Effectiveness of a "Case Management Algorithm" After a Suicide Attempt in Terms of Repetition of the Suicidal Behaviors and Medico-economic Impact

acronym: ALGOS

summary:
The suicidal behaviors are phenomena eminently multifactorial. It is thus always difficult to define univocal strategies of prevention of suicide repetition, during the emergency stay, i.e. almost in general population. One find 23 clinical trials in this topic in the past 25 years, and 18 are negative. The majority of the positive trials have the concern of being dissociated from an assumption of responsibility of care strictly speaking, to adopt a position "méta", nearer to the concept of "case management": how to remain in contact with the suicide attempter, without forcing it in this every day life, replacing a possible proposing, but assumption of responsibility resources reliable and quickly accessible in the event of at risk situation? Each one of these studies tests devices which seem more appropriate to such or such characteristic of this population, by retaining only simple criteria like the sex, the number of former suicide attempts, the proposal or not for an assumption of responsibility of care, the observance or not with the plan of care. Thus, it would seem interesting to combine these approaches in an algorithm entitled "ALGOS".

Main aim: To test the effectiveness of this algorithm of case management, named "ALGOS", in reducing the number of death by suicide, in terms of reduction of suicide re-attempts and the number of loss of contact patients in the ALGOS group during 6 months period, compared to a control group of suicide attempters treated as usual (i.e. primarily transmitted to the attending physician).

Secondary objectives: To evaluate, according to the method validated by Beecham in 1992, direct medico-economic impact in the year which follows the introduction of algorithm ALGOS. Reduction of the other suicidal behaviors in 6 months (reduction in the full number of suicidal repetitions in each group, evolution of the score of suicidal ideation, etc…). To evaluate the effect of the algorithm, at the 13th month. To study the possible differences within the time in terms of suicidal repetitions in the 2 groups. To propose different profiles of answers according to psychopathology, the number of suicide attempts, suicidal character, the sex,…

Methodology: Comparative simple blind prospective multicentric controlled study

primary_purpose: Supportive Care

ReferenceCitation: Vaiva G, Vaiva G, Ducrocq F, Meyer P, Mathieu D, Philippe A, Libersa C, Goudemand M. Effect of telephone contact on further suicide attempts in patients discharged from an emergency department: randomised controlled study. BMJ. 2006 May 27;332(7552):1241-5.

ReferenceCitation: Carter GL, Clover K, Whyte IM, Dawson AH, D'Este C. Postcards from the EDge project: randomised controlled trial of an intervention using postcards to reduce repetition of hospital treated deliberate self poisoning. BMJ. 2005 Oct 8;331(7520):805. Epub 2005 Sep 23.

ReferenceCitation: Evans J, Evans M, Morgan HG, Hayward A, Gunnell D. Crisis card following self-harm: 12-month follow-up of a randomised controlled trial. Br J Psychiatry. 2005 Aug;187:186-7.

ReferenceCitation: Vaiva G, Walter M, Al Arab AS, Courtet P, Bellivier F, Demarty AL, Duhem S, Ducrocq F, Goldstein P, Libersa C. ALGOS: the development of a randomized controlled trial testing a case management algorithm designed to reduce suicide risk among suicide attempters. BMC Psychiatry. 2011 Jan 2;11:1. doi: 10.1186/1471-244X-11-1.

ReferenceCitation: Demesmaeker A, Chazard E, Vaiva G, Amad A. Risk Factors for Reattempt and Suicide Within 6 Months After an Attempt in the French ALGOS Cohort: A Survival Tree Analysis. J Clin Psychiatry. 2021 Feb 18;82(1). pii: 20m13589. doi: 10.4088/JCP.20m13589.

family: Demesmaeker

full_name: Alice Demesmaeker

given: Alice

family: Chazard

full_name: Emmanuel Chazard

given: Emmanuel

family: Vaiva

full_name: Guillaume Vaiva

given: Guillaume

family: Amad

full_name: Ali Amad

given: Ali

journal_name: The Journal of Clinical Psychiatry

oa_host_type: publisher

publisher: Physicians Postgraduate Press, Inc

publisher_dissemination: Physicians Postgraduate Press, Inc

publisher_group: Physicians Postgraduate Press, Inc

publisher_normalized: Physicians Postgraduate Press, Inc

ReferenceCitation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4:CD013668. doi: 10.1002/14651858.CD013668.pub2.

name: Centre for Youth Mental Health; The University of Melbourne; Melbourne Australia

family: Witt

full_name: Katrina G Witt

given: Katrina G

name: Department of Psychological Medicine, Faculty of Medical and Health Sciences; The University of Auckland; Auckland New Zealand

family: Hetrick

full_name: Sarah E Hetrick

given: Sarah E

family: Rajaram

full_name: Gowri Rajaram

given: Gowri

name: Speciality of Psychiatry; University of Sydney School of Medicine; Sydney Australia

family: Hazell

full_name: Philip Hazell

given: Philip

name: Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience; King's College London; London UK

family: Taylor Salisbury

full_name: Tatiana L Taylor Salisbury

given: Tatiana L

name: Self-Harm Research Group, School of Psychology; University of Nottingham; Nottingham UK

family: Townsend

full_name: Ellen Townsend

given: Ellen

name: Centre for Suicide Research, Department of Psychiatry; University of Oxford; Oxford UK

family: Hawton

full_name: Keith Hawton

given: Keith

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

repository_normalized: University of Melbourne - Minerva Access

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

license: cc-by

license_normalized: cc-by

repository_institution: University of Nottingham - Repository@Nottingham

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

repository_institution: University of Bristol - Bristol Research

ReferenceCitation: Vaiva G, Berrouiguet S, Walter M, Courtet P, Ducrocq F, Jardon V, Larsen ME, Cailhol L, Godesense C, Couturier C, Mathur A, Lagree V, Pichene C, Travers D, Lemogne C, Henry JM, Jover F, Chastang F, Prudhomme O, Lestavel P, Gignac CT, Duhem S, Demarty AL, Mesmeur C, Bellivier F, Labreuche J, Duhamel A, Goldstein P. Combining Postcards, Crisis Cards, and Telephone Contact Into a Decision-Making Algorithm to Reduce Suicide Reattempt: A Randomized Clinical Trial of a Personalized Brief Contact Intervention. J Clin Psychiatry. 2018 Sep 25;79(6). pii: 17m11631. doi: 10.4088/JCP.17m11631.

location_facility: Georges Pompidou European Hospital, Paris


title: SLEEP DISORDERED BREATHING DURING CARDIAC REHABILITATION A Study of the Improvement in Physical Performance of Patients With Heart Failure During Cardiac Rehabilitation Due to the Correction of Sleep Disordered Breathing

acronym: SATELIT-HF

summary: Sleep disordered breathing (SDB) is a frequent comorbidity for heart failure patients. Its prevalence varies according to the seriousness of the condition of the patients, but it is present in approximately 50% of patients. Screening patients for SDB and managing them by providing adapted ventilation therapy should improve their quality of life or even their prognosis. Moreover, SDB lowers nocturnal cardiovascular recovery abilities and leads to an increase in fatigability and, as a result, exercise intolerance in patients with heart failure. Physical training as part of a cardiac rehabilitation programme provides many benefits, including improving patients' exercise capacities. Our hypothesis is that adapted sleep disordered breathing therapy during rehabilitation will lead to an improvement in rehabilitation results.

primary_purpose: Prevention

lead_sponsor: French Cardiology Society

location_facility: Hôpital Intercommunal Sud Léman Valserine

location_facility: Centre de réadaptation cardiaque Leopold Bellan

location_facility: Clinique de réadaptation cardiaque Cardiocéan

intervention_type: Other


title: Evaluation of Compliance With Management of Acute Coronary Syndrome on Discharge From Cardiac Intensive Care (CIC) - Electronic Measurement of Compliance

acronym: SCAVANCE

summary: To study compliance with secondary prevention during the first months following discharge from the cardiac intensive care unit (CIC) of patients experiencing a first episode of acute coronary syndrome : quantitative compliance over 3 months with the two principal treatments of the prescription (a statin - rosuvastatin, Crestor® and a platelet aggregation inhibitor - clopidogrel, Plavix®), using an electronic measure system ("intelligent blister" pack®);

study_completion_date_type: Anticipated

enrollment_type: Anticipated


ReferenceCitation: Aupérin A, Le Péchoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29. Review.

ReferenceCitation: Tredaniel J, Mornex F, Barillot I, Diaz O, Hennequin C, Le Pechoux C, Lavole A, Giraud P, Souquet PJ, Teixeira L, Vaylet F, Zalcman G, Baudrin L, Morin F, Milleron B. [A phase II study of cetuximab, pemetrexed, cisplatin, and concurrent radiotherapy in patients with locally advanced, unresectable, stage III, non squamous, non-small cell lung cancer (NSCLC)]. Rev Mal Respir. 2011 Jan;28(1):51-7. doi: 10.1016/j.rmr.2010.06.027. Epub 2011 Jan 11. French.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Hôpitaux Universitaires - Nouvel Hôpital Civil

title: Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)

summary: Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.


title: Evaluation of the Effect of Probiotic Lactobacillus Paracasei Lp-33 for the Management of Rhinitis in People Sensitized to Allergens. A Double Blind Randomized Parallel Placebo Controlled Study. (GA2LEN STUDY) BIONATLANTA Project

acronym: BionAtlanta

summary: The aim of the study is to show an improvement of quality of life on the 5th week of product consumption (probiotic Lactobacillus paracasei LP-33)(as assessed by RQLQ global score) in subjects with persistent allergic rhinitis currently treated with Loratadine or oral anti-histaminic treatment.

lead_sponsor: Merck Medication Familiale

location_facility:
Claude BRUNAUD
Olivier BISCH
Jean Pascal SASTOURNE
Alain LION
Guy BIRRY
Michel CHASSAGNE
Philippe IMBERT
Jacques RAMBAUD
Alain GIACOMINO
Raymond ATTUIL
Philippe GRUJARD
Marie Pascale DEMOLY
Georgios MARKIDIS
Victor BASTIDE
Christian DAUGENET
Pascal MABIRE
Claire ROLLAND-JACQUEMIN
Catherine BRUNET-CAZOT
Thierry CANALI
Claire PFRUNNER-SCHNEIDER
Jean-Philippe RICHTER
Sabine GRUTTER
Jean-Louis WURTZ
Raymond WESTERFELD
Jean-Baptiste DE LEMOS
Hervé MOREL
COSTA
Jean DEFLAUX
Judah TOLEDANO
Léa ABOAF
Gladys HAVARD
Marie Christine BONS-GALLET
Cécile BELIN-SAUGET
Hélène STURCHLER
Patrick VERDAVOINE
Sylvie OLLIVIER
Geneviève DURANT
Eric LIOTARD
Emmanuel DEJOUX
Natacha HEITZ
Dominique BLOT
Christian GIRARD
François LE HINGRAT
Jean-Yves DOERR
Jean Roch ALEA
Thierry AUTARD
Béatrice LOGNOS-FOLCO
Nathan ABENHAIM
Patrick OLOMBEL
Gabriel VENTURINI
Paul REGNIER-VIGOUROUX
Corinne SION
Robert COMBET
Yves MERCEY
Irène LAFONT
Gregoire MARTOCQ
Chantal MARTIN
Patrick VOGT
Dominique GENOUD
Laurence DAGES
Bruno DAUBIN
Nicolas BRETON
Charles LOUSQUI
Jean Pierre CANO
Bernard GABBAI
Patrick DUTILLEUL
Georges BINET
Hervé VILAREM
Monique LESCOUTE
Dominique EDET
Michel AMOUYAL
Alain GUERRI
Roland BENEDIC
Reinhard RENNER
Christian FLAISSIER
Maurice GAY
Jacques GRAVES
François BAYLE
MONGIN
Sophie ROSENBERG
Bernard CLARY
Baudoin PINSON
Philippe MARMOR
Sylvie CHABROL-RIVIERE
Stéphane BOURGHOL
Gérard BOURREL
Olivier BAISSAS
Daniel FERET
Martine FERRE
Patrick KORMANN
Bernard PRIJAC
Philippe HEUZE
Bernadette CHAUFFAILLE
Véronique PEREZ
Gérard DUGNY
Luc ECHINARD
Philippe BOISSON
Marc BUR
Florian KOMAC
Nasser GOUCHENE
Catherine AYRAL
Sonia COURTOIS
Claude BERNAT
Yves-Olivier SCHLECHT
Thierry STEFANAGGI
Catherine MERCEY
Chantal MALZAC
Gérard TELLIER
Joël ETIENNEZ
Sébastien CONVENT
Philippe PIAT
Marc GARCIA
Nicole FERRIER
Serge ELIE
Jean Baptiste THIBERT
Alain FAUDIN
Gil MEYRAND
Philippe CAYRON
Jean François GUILLEM
Maxime BOUMANDIL
Laurent TENNEZE
Frédéric RENOU
Marcel RUETSCH
Olivier CHAIX
Didier CADINOT

intervention_type: Dietary Supplement


title: Phase 3 Study of Hydrocortisone and Fludrocortisone in Glucocorticoid Insufficiency Related to Traumatic Brain Injury

acronym: Corti-TC

summary:
Traumatic brained injured (TBI) patients frequently suffered from glucocorticoid insufficiency that is associated with a raise in the rate of pneumonia.

In a placebo-controlled, multi-center, double-blinded trial, treatment of glucocorticoid insufficiency (hydrocortisone associated with fludrocortisone) will be assessed for prevention of post trauma pneumonia in a population of severe TBI patients.

ReferenceCitation: Asehnoune K, Roquilly A, Sebille V; Corti-TC trial group. Corticotherapy for traumatic brain-injured patients--the Corti-TC trial: study protocol for a randomized controlled trial. Trials. 2011 Oct 14;12:228. doi: 10.1186/1745-6215-12-228.

ReferenceCitation: Asehnoune K, Seguin P, Allary J, Feuillet F, Lasocki S, Cook F, Floch H, Chabanne R, Geeraerts T, Roger C, Perrigault PF, Hanouz JL, Lukaszewicz AC, Biais M, Boucheix P, Dahyot-Fizelier C, Capdevila X, Mahe PJ, Le Maguet P, Paugam-Burtz C, Gergaud S, Plaud B, Constantin JM, Malledant Y, Flet L, Sebille V, Roquilly A; Corti-TC Study Group. Hydrocortisone and fludrocortisone for prevention of hospital-acquired pneumonia in patients with severe traumatic brain injury (Corti-TC): a double-blind, multicentre phase 3, randomised placebo-controlled trial. Lancet Respir Med. 2014 Sep;2(9):706-16. doi: 10.1016/S2213-2600(14)70144-4. Epub 2014 Jul 24. Erratum in: Lancet Respir Med. 2014 Sep;2(9):e15.

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Seguin

full_name: Philippe Seguin

given: Philippe

family: Allary

full_name: Jeremy Allary

given: Jeremy

family: Feuillet

full_name: Fanny Feuillet

given: Fanny

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

family: Cook

full_name: Fabrice Cook

given: Fabrice

family: Floch

full_name: Hervé Floch

given: Hervé

family: Chabanne

full_name: Russell Chabanne

given: Russell

family: Geeraerts

full_name: Thomas Geeraerts

given: Thomas

family: Roger

full_name: Claire Roger

given: Claire

family: Perrigault

full_name: Pierre F Perrigault

given: Pierre F

family: Hanouz

full_name: Jean L Hanouz

given: Jean L

family: Lukaszewicz

full_name: Anne C Lukaszewicz

given: Anne C

family: Biais

full_name: Matthieu Biais

given: Matthieu

family: Boucheix

full_name: Perrine Boucheix

given: Perrine

family: Dahyot-Fizelier

full_name: Claire Dahyot-Fizelier

family: Capdevila

full_name: Xavier Capdevila

given: Xavier

family: Mahe

full_name: Pierre J Mahe

given: Pierre J

family: Maguet

full_name: Pascale Le Maguet

given: Pascale Le

family: Paugam-Burtz

full_name: Catherine Paugam-Burtz

given: Catherine

family: Gergaud

full_name: Soizic Gergaud

given: Soizic

family: Plaud

full_name: Benoit Plaud

given: Benoit

family: Constantin

full_name: Jean M Constantin

location_facility:
Universtiy Hospital
University Hospital
University hospital
Saint Louis Hospital
European Hospital Georges Pompidou


status: Active, not recruiting

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

acronym: ReChiVe

location_facility: APHM - Marseille - Hôpital de la Conception

location_facility: INSTITUT CLAUDIUS REGAUD - CRLC Toulouse

title: Prospective Multicentric Evaluation of a Bladder Preservation Strategy Using a Combination of Neoadjuvant Chemotherapy and Optimal Bladder Transurethral Resection in Patients With a Urothelial Carcinoma

summary:
Radical cystectomy is the treatment of choice for bladder infiltrative urothelium carcinoma. But the removal of the bladder reservoir has a major impact of the Quality of life. Neoadjuvant chemotherapy has been shown to be associated with an absolute 5% survival benefit. Two monocentric studies suggest that this neoadjuvant chemotherapy could be used in combination with an optimal transurethral bladder resection, in a strategy of bladder preservation, provided a complete response being obtained (about 50% in every trial using neoadjuvant MVAC protocol before a radical cystectomy). In those both studies with patients T2 to T4, the 5 years overall survival is above 65%, with more than 40% bladder preservation rate at 5 years.

The feasibility and the efficacy of such an attitude in a multicentric trail using the most active regimen (in term of complete response in metastatic patients) is unknown. The chosen regimen is therefore the intensified MVAC which allows, with the use of G-CSF, to double the dose-intensity of Adriamycin and Cisplatinum, and to decrease by 30% the methotrexate and vinblastine dose-intensity.

The efficacy and safety confirmation of such an approach could lead to consider it in patients motivated to retain a functional bladder.

status_simplified: Ongoing


title: A Phase II Study of the Efficacy and Safety of Lenalidomide Combined to Azacitidine in Intermediate-2 or High Risk MDS With Del 5q

summary:
Higher risk MDS with del(5q) carry very poor prognosis, but show some response to azacitidine and Lenalidomide as single agents . The combination of Lenalidomide and Azacytidine is currently tested in non del 5q MDS patients. Preliminary results have been recently presented at ASH meeting (Sekeres et al, 2007).

Overall, the combination of Lenalidomide and Azacitidine is well-tolerated and early results suggest some efficacy in advanced MDS without del 5q.

In this trial, we will combine Lenalidomide to Azacytidine in higher risk MDS with del (5q).

Patients will receive azacitidine( 75mg/m2/day for 5 days every 28 days) combined to escalating doses of lenalidomide (starting at relatively low dose).

For patients in hematological CR, PR, HI or marrow CR after cycle 2 or 4, it is mandatory to continue on Azacitidine + Lenalidomide as long as there is no unacceptable toxicity or overt progression, with the schedule that yielded response.

In patient still responding after 52 weeks, the drug will continue to be supplied, and follow up until death will be continued in all patients.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Hôpital Edouard Heriot, dpt Hématologie Clinique

location_facility: Hôpital PURPAN, Service d'Hématologie Clinique

location_facility: Institut Paoli-Calmette, Département d'hématologie


title: Large Scale Study of DNA Copy Numbers Variations and Gene Expression Profile of Bone Marrow Plasma Cells From Monoclonal Gammopathy of Undetermined Significance (MGUS) and Indolent Myeloma (SMM).

acronym: GENOMGUS

summary: The purpose of this study is to describe DNA copy number variations and gene expression profiles of bone marrow plasma cells of monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). The final objective is to search for correlations with the risk of progression in order to establish a predictive model of early malignant transformation.

lead_sponsor: Rennes University Hospital

location_facility: Service d'Hématologie - Hôpital de Brabois

location_facility: Service de Médecine interne - Centre Hospitalier

location_facility: Centre Hospitalier Yves Le Foll de Saint Brieuc - Service d'Hématologie

intervention_type: Genetic


ReferenceCitation: Loupy A, Aubert O, Orandi BJ, Naesens M, Bouatou Y, Raynaud M, Divard G, Jackson AM, Viglietti D, Giral M, Kamar N, Thaunat O, Morelon E, Delahousse M, Kuypers D, Hertig A, Rondeau E, Bailly E, Eskandary F, Böhmig G, Gupta G, Glotz D, Legendre C, Montgomery RA, Stegall MD, Empana JP, Jouven X, Segev DL, Lefaucheur C. Prediction system for risk of allograft loss in patients receiving kidney transplants: international derivation and validation study. BMJ. 2019 Sep 17;366:l4923. doi: 10.1136/bmj.l4923.

apc_source: openAPC

family: Loupy

full_name: Alexandre Loupy

given: Alexandre

family: Aubert

full_name: Olivier Aubert

given: Olivier

family: Orandi

full_name: Babak J Orandi

given: Babak J

family: Naesens

full_name: Maarten Naesens

given: Maarten

family: Bouatou

full_name: Yassine Bouatou

given: Yassine

family: Raynaud

full_name: Marc Raynaud

given: Marc

family: Divard

full_name: Gillian Divard

given: Gillian

family: Jackson

full_name: Annette M Jackson

given: Annette M

family: Viglietti

full_name: Denis Viglietti

given: Denis

family: Giral

full_name: Magali Giral

given: Magali

family: Kamar

full_name: Nassim Kamar

given: Nassim

family: Thaunat

full_name: Olivier Thaunat

family: Morelon

full_name: Emmanuel Morelon

given: Emmanuel

family: Delahousse

full_name: Michel Delahousse

given: Michel

family: Kuypers

full_name: Dirk Kuypers

given: Dirk

family: Hertig

full_name: Alexandre Hertig

family: Rondeau

full_name: Eric Rondeau

given: Eric

family: Bailly

full_name: Elodie Bailly

given: Elodie

family: Eskandary

full_name: Farsad Eskandary

given: Farsad

family: Böhmig

full_name: Georg Böhmig

given: Georg

family: Gupta

full_name: Gaurav Gupta

given: Gaurav

family: Glotz

full_name: Denis Glotz

family: Legendre

full_name: Christophe Legendre

given: Christophe

family: Montgomery

full_name: Robert A Montgomery

given: Robert A

family: Stegall

full_name: Mark D Stegall

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

title: Prospective, Multicenter, Randomized Open Study to Evaluate the Progression of Renal Graft Fibrosis According to the Epithelial-mesenchymal Transition (EMT) in de Novo Renal Transplant Recipients Treated Either by a CNI Free Immunosuppressive Regimen With Everolimus and Enteric-coated Mycophenolate Sodium or a CNI Based Regimen With Cyclosporine and Enteric-coated Mycophenolate Sodium

summary: Recently, early biomarkers of renal interstitial fibrosis have been identified, amongst them de novo expression of vimentin by tubular epithelial cells, which is an intermediate filament, and the translocation of beta-catenin into their cytoplasm. These markers, when present, suggest that the epithelial cell undergoes a phenomenon well known as "epithelial to mesenchymal transition" (EMT) and could behaves like a myo-fibroblast. EMT is highly instrumental in several models of tissue fibrosis, including in the kidney. Actually, it has not only been demonstrated that these markers are detectable in the renal graft at an early time point post-transplant (i.e. as soon as three months), but also that the intensity of their expression correlates with the progression of interstitial fibrosis of the graft between 3 and 12 months


title: A Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation

summary: To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation

lead_sponsor: Pfizer


title: Multicentric Prospective Randomized Study Comparing Technique of Tension-free Repair With Placement of a Bovine Pericardium Bioprosthesis (Tutopatch® and Tutomesh®) to Current Conventional Surgical Techniques in Potentially Contaminated Hernia Repair and Abdominal Wall Reconstruction

acronym: Tutomesh

summary:
This is a multicentric prospective randomized study comparing technique of tension-free repair with placement of a bovine pericardium bioprosthesis (Tutopatch® and Tutomesh®) to current conventional surgical techniques in potentially contaminated hernia repair and abdominal wall reconstruction.

The hypothesis is that using Tutomesh® prostheses reduces the risk of postoperative complications at 30 days in the treatment of incisional hernias or complicated abdominal wall hernias (ref early complications) for potentially contaminated fields.

lead_sponsor: Centre Hospitalier Régional Universitaire Montpellier

location_facility:
Hôpital Nord
Ch Antibes-Juan les pins
CHU Hôtel Dieu
CH Hautepierre
CHG Beziers
CHU Trousseau
CH Aix en Provence
CH Nimes
CHU Amiens
CH Salon de Provence
CHU Archet II
CHU Rangueil
CHU Grenoble
Clinique de la Casamance
CHU Nantes
CH St Eloi
CHU Jean Verdier
CHU Fréjus
CH Avignon


title: A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid (ATRA) in Combination With Induction Chemotherapy, or Azacitidine and Idarubicin as Salvage Therapy and Idarubicin With Cytarabine or Azacitidine as Maintenance Therapy in Older Patients With Acute Myeloblastic Leukemia (AML)

summary:
A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid (ATRA) in Combination with Induction Chemotherapy, or Azacitidine and Idarubicin as salvage therapy and Idarubicin with Cytarabine or Azacitidine as Maintenance Therapy in Older Patients with Acute Myeloblastic Leukemia (AML).

To compare the outcome of elderly patients with newly-diagnosed AML treated with standard induction chemotherapy and post-remission therapy, in only patients in CR, with either azacitidine or cytarabine combined to idarubicin +/- ATRA and salvage therapy with azacitidine combined to idarubicin +/- ATRA.

status: Withdrawn

lead_sponsor: Acute Leukemia French Association

location_facility:
Centre Antoine Lacassagne
Hopital Avicenne
CH
Chu Boulogne Sur Mer
Ch Rene Dubos
Hopital Henri Mondor
Hopital Pitie-Salpetriere
Hopital Edouard Herriot
Necker Hospital
Ch Dunkerque
Ch Sud Francilien
Hopital Saint-Louis
CNLCC
St Antoine Hospital
Chu Amiens Sud
CHU
Hopital Percy
IGR


title: Phase III Study of Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation.

acronym: RITUX-ERAH

summary: Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a composite "TREATMENT FAILURE"

status: Unknown status

lead_sponsor: University Hospital, Tours

location_facility:
Hospital Bretonneau
Hospital Maison Blanche
Hospital Hôtel Dieu
Hospital Saint-Jacques
Hospital Lapeyronie
Hospital Dupuytren
Hospital Edouard Herriot
Hospital Lyon Sud
Hospital Bois-Guillaume
Hospital Bocage
Hospital Pitié-Salpêtrière
Hospital Saint Louis
Hospital Calmette
Hospital Pasteur
Hospital Pellegrin
Hospital Sud
Hospital Henri Mondor
Hospital Conception
Hospital Gabriel Montpied
Hospital Bicêtre
Hospital Civil
Hospital Foch
Hospital Nord
Hospital Tenon
Hospital
Hospital Nancy-Brabois
Hospital Milétrie Jean Bernard
Hospital Necker


title: Evaluation of Target Organs Damage in Hypertensive Patients Followed in General Practice With no Known Cardiovascular (CV) or Renal Disease, Stratified According to Blood Pressure Control

acronym: PreVENT-A GP

summary: Evaluation of target organs damage in hypertensive patients with no known cardiovascular (CV) or renal disease, stratified according to level of blood pressure control

time_perspective: Cross-Sectional


ReferenceCitation: Leleu X, Attal M, Arnulf B, Moreau P, Traulle C, Marit G, Mathiot C, Petillon MO, Macro M, Roussel M, Pegourie B, Kolb B, Stoppa AM, Hennache B, Bréchignac S, Meuleman N, Thielemans B, Garderet L, Royer B, Hulin C, Benboubker L, Decaux O, Escoffre-Barbe M, Michallet M, Caillot D, Fermand JP, Avet-Loiseau H, Facon T; Intergroupe Francophone du Myélome. Pomalidomide plus low-dose dexamethasone is active and well tolerated in bortezomib and lenalidomide-refractory multiple myeloma: Intergroupe Francophone du Myélome 2009-02. Blood. 2013 Mar 14;121(11):1968-75. doi: 10.1182/blood-2012-09-452375. Epub 2013 Jan 14.

family: Leleu

full_name: Xavier Leleu

given: Xavier

family: Attal

full_name: Michel Attal

family: Arnulf

full_name: Bertrand Arnulf

given: Bertrand

family: Moreau

full_name: Philippe Moreau

given: Philippe

name: Centres Hospitaliers Lyon Sud et Edouard Herriot, Lyon, France;

family: Traulle

full_name: Catherine Traulle

given: Catherine

name: Hôpital du Haut-Lévèque, Bordeaux Pessac, France;

family: Marit

full_name: Gerald Marit

given: Gerald

family: Mathiot

full_name: Claire Mathiot

given: Claire

family: Petillon

full_name: Marie Odile Petillon

given: Marie Odile

family: Macro

full_name: Margaret Macro

given: Margaret

family: Roussel

full_name: Murielle Roussel

given: Murielle

family: Pegourie

full_name: Brigitte Pegourie

given: Brigitte

family: Kolb

full_name: Brigitte Kolb

name: Institut Paoli Calmettes, Marseille, France;

family: Stoppa

full_name: Anne Marie Stoppa

given: Anne Marie

family: Hennache

full_name: Bernadette Hennache

given: Bernadette

family: Bréchignac

full_name: Sabine Bréchignac

given: Sabine

name: Institute Jules Bordet, ULB, Brussels, Belgium;

family: Meuleman

full_name: Nathalie Meuleman

given: Nathalie

family: Thielemans

full_name: Beatrice Thielemans

given: Beatrice

family: Garderet

full_name: Laurent Garderet

given: Laurent

family: Royer

full_name: Bruno Royer

given: Bruno

name: Hôpital de Brabois, Nancy-Brabois, Vandoeuvre, France;

family: Hulin

full_name: Cyrille Hulin

given: Cyrille

family: Benboubker

full_name: Lotfi Benboubker

given: Lotfi

family: Decaux

full_name: Olivier Decaux

given: Olivier

family: Escoffre-Barbe

full_name: Martine Escoffre-Barbe

given: Martine

name: Hôpital Edouard Herriot, Lyon, France; and

family: Michallet

full_name: Mauricette Michallet

given: Mauricette

family: Caillot

full_name: Denis Caillot

title: Pomalidomide plus low-dose dexamethasone is active and well tolerated in bortezomib and lenalidomide–refractory multiple myeloma: Intergroupe Francophone du Myélome 2009-02

location_facility: Onco-Hématologie, CHRU- Hôpital Bretonneau

location_facility: Hématologie Clinique, CHU, Hôpital d'Enfants

location_facility: Service Immuno-Hématologie, Hôpital Saint-Louis

location_facility: Maladies du Sang, CHU - Hôpital St Antoine

location_facility: Hématologie Clinique, Hôpital Robert Debré, CHU Reims

location_facility: Service d'Hématologie, Centre Hospitalier Lyon Sud

location_facility: Service des Maladies du Sang, Hôpital Haut-Levèque

title: A Multicenter Randomized Open Label Phase II Study of Pomalidomide and Dexamethasone in Relapse and Refractory Multiple Myeloma Patients Who Are Progressive and Did Not Achieve at Least a Partial Response to Bortezomib and Lenalidomide

summary: The purpose of this study is to evaluate the response to pomalidomide and dexamethasone in relapse and refractory MM patients who are progressive and did not achieve at least a partial response to bortezomib and lenalidomide. This study will determine the efficacy and toxicity profile of 2 modalities of pomalidomide in patients with advanced myeloma, previously heavily treated characterized with adverse prognostic and that are in desperate need of novel therapeutics.


title: Multicenter, Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery or Invasive Procedures.

acronym: RECO

summary: Non cardiac surgery in patients with coronary stents is complicated with cardiovascular and hemorrhagic events associated with perioperative management of antiplatelet agents. Several guidelines have outlined the importance of maintaining antiplatelet agents throughout surgical procedures to prevent cardiovascular complications. On the other hand, interruption of antiplatelet agents is still a usual standard to avoid surgical complications. We investigate the impact of perioperative antiplatelet drugs management on these complications, through a multicenter, prospective cohort (RECO stands for "Registre des patients porteurs d'Endoprothèses Coronaires, Opérés de chirurgie non cardiaque"), including all patients with coronary stents undergoing non cardiac surgery or invasive procedures. The aim of this study is primarily to measure the incidence of cardiovascular (including stent thrombosis) and hemorrhagic complications and to identify pre and postoperative risk factors associated with these complications.

ReferenceCitation: Albaladejo P, Charbonneau H, Samama CM, Collet JP, Marret E, Piriou V, Genty C, Bosson JL. Bleeding complications in patients with coronary stents during non-cardiac surgery. Thromb Res. 2014 Aug;134(2):268-72. doi: 10.1016/j.thromres.2014.05.015. Epub 2014 May 15.

family: Albaladejo

full_name: Pierre Albaladejo

given: Pierre

family: Charbonneau

full_name: Hélène Charbonneau

given: Hélène

family: Samama

full_name: Charles-Marc Samama

given: Charles-Marc

family: Collet

full_name: Jean-Philippe Collet

given: Jean-Philippe

family: Marret

full_name: Emmanuel Marret

given: Emmanuel

family: Piriou

full_name: Vincent Piriou

given: Vincent

family: Genty

full_name: Celine Genty

given: Celine

family: Bosson

full_name: Jean Luc Bosson

given: Jean Luc

journal_name: Thrombosis Research

ReferenceCitation: Albaladejo P, Marret E, Samama CM, Collet JP, Abhay K, Loutrel O, Charbonneau H, Jaber S, Thoret S, Bosson JL, Piriou V. Non-cardiac surgery in patients with coronary stents: the RECO study. Heart. 2011 Oct;97(19):1566-72. doi: 10.1136/hrt.2011.224519. Epub 2011 Jul 26.

full_name: P. Albaladejo

given: P.

full_name: E. Marret

given: E.

full_name: C.-M. Samama

full_name: J.-P. Collet

family: Abhay

full_name: K. Abhay

given: K.

family: Loutrel

full_name: O. Loutrel

given: O.

full_name: H. Charbonneau

given: H.

family: Jaber

full_name: S. Jaber

given: S.

family: Thoret

full_name: S. Thoret

full_name: J.-L. Bosson

full_name: V. Piriou

given: V.

journal_name: Heart

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal


type: Registry Identifier

title: A Phase II Study of Bendamustine, Velcade and Dexamethasone (BVD) in the Treatment of Elderly Patients (>= 65 Years) With Multiple Myeloma in 1st Relapse or Refractory to 1st Line Therapy

acronym: BVD

summary:
The present trial is designed as a phase II study that aims at estimating the efficacy of the combination of bendamustine, bortezomib and dexamethasone in relapsed/refractory multiple myeloma (MM). The response rate, i.e. the rate of the patients achieving a Complete Response or Partial Response at cycle 4, divided by the total intent to treat patient number is chosen as primary efficacy endpoint.

The estimation of the efficacy rate is to be based on an explorative pilot study, since immediate embarking on a large-scale comparative efficacy trial would not be acceptable from the point of view of resources. Moreover, this would induce ethical objections, as it does not seem to be justifiable to expose a large number of patients to an experimental approach without sufficient exploratory indications of an improved risk-benefit ratio.

ReferenceCitation: Rodon P, Hulin C, Pegourie B, Tiab M, Anglaret B, Benboubker L, Jardel H, Decaux O, Kolb B, Roussel M, Garderet L, Leleu X, Fitoussi O, Chaleteix C, Casassus P, Lenain P, Royer B, Banos A, Benramdane R, Cony-Makhoul P, Dib M, Fontan J, Stoppa AM, Traullé C, Vilque JP, Pétillon MO, Mathiot C, Dejoie T, Avet-Loiseau H, Moreau P. Phase II study of bendamustine, bortezomib and dexamethasone as second-line treatment for elderly patients with multiple myeloma: the Intergroupe Francophone du Myelome 2009-01 trial. Haematologica. 2015 Feb;100(2):e56-9. doi: 10.3324/haematol.2014.110890. Epub 2014 Nov 14.

family: Rodon

full_name: P. Rodon

family: Hulin

full_name: C. Hulin

given: C.

family: Pegourie

full_name: B. Pegourie

given: B.

family: Tiab

full_name: M. Tiab

given: M.

family: Anglaret

full_name: B. Anglaret

family: Benboubker

full_name: L. Benboubker

given: L.

family: Jardel

full_name: H. Jardel

full_name: O. Decaux

family: Kolb

full_name: B. Kolb

family: Roussel

full_name: M. Roussel

family: Garderet

full_name: L. Garderet

family: Leleu

full_name: X. Leleu

given: X.

family: Fitoussi

full_name: O. Fitoussi

family: Chaleteix

full_name: C. Chaleteix

family: Casassus

full_name: P. Casassus

family: Lenain

full_name: P. Lenain

family: Royer

full_name: B. Royer

family: Banos

full_name: A. Banos

given: A.

family: Benramdane

full_name: R. Benramdane

given: R.

family: Cony-Makhoul

full_name: P. Cony-Makhoul

family: Dib

full_name: M. Dib

family: Fontan

full_name: J. Fontan

given: J.

family: Stoppa

full_name: A.-M. Stoppa

publisher: Ferrata Storti Foundation (Haematologica)

location_facility: Centre Hospitalier de la Région d'Annecy


ReferenceCitation: Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10:CD012569. doi: 10.1002/14651858.CD012569.pub2.

name: Department of Pharmacology; School of Pharmacy, Fudan University; Shanghai China

family: Wang

full_name: Gan Mi Wang

given: Gan Mi

family: Li

full_name: Liang Jin Li

given: Liang Jin

family: Tang

full_name: Wen Lu Tang

given: Wen Lu

name: Department of Anesthesiology, Pharmacology and Therapeutics; University of British Columbia; Vancouver Canada

family: Wright

full_name: James M Wright

given: James M

lead_sponsor: Novartis

acronym: ALIAS

location_facility:
Investigative Site
Novartis Investigator Site
Novartis Investigative Site

title: Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients

summary: This prospective multicenter, double blind study will evaluate the efficacy and safety of aliskiren versus ramipril in patients with moderate systolic essential hypertension.


title: Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment

acronym: GRATSEC

summary:
This is a phase III randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision.

It is planned that 440 patients participate in this study which plans to compare 2 groups of patients: a group of patients which will benefit from the surgical treatment by transfer of fatty tissue and a group of patients under simple supervision.

follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months, 12 months and 5 years to look for the expected unwanted effects in relation with the surgery but also to estimate the impact of the fatty transfer on the rate of local and\or from a distance relapse.

During these consultations, the surgeon and the patient will also estimate the cosmetic result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized photos.

location_facility: INSTITUT DE CANCEROLOGIE DE L'OUEST - Centre René Gauducheau


design_allocation: Non-Randomized

intervention_type: Biological

title: A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 6096A1-008-EU and the Safety and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Administered at Least 24 Months After the Last Toddler Dose of Pneumococcal Conjugate Vaccine

summary: This is an open-label study (a study in which the doctors and participants know which drug or vaccine is being administered) in children who previously received a 4-dose series of a pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In this study, participants will receive an additional dose of 13-valent pneumococcal conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody response by measuring any remaining pneumococcal antibodies since the previous study. This study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine when administered at least 24 months after the last dose of pneumococcal conjugate vaccine.


title: A Phase II Study of Azacitidine (Vidaza®) Combined to Epoetin Beta (NeoRecormon®) in IPSS Low-risk and Intermediate-1 MDS Patients, Resistant to ESA

summary: The study is aimed to treat low-risk MDS patients,who are dependent on red-blood cell transfusion due to disease-related anemia, and who have a proven resistance towards treatment with erythropoetin-stimulating agents (ESA). The study randomizes patients to receive a treatment with the demethylating agent 5-azacytidine alone or in combination with an ESA. The study thus evaluates, if efficacy of 5-azacytidine, notably on the red-blood cell transfusion-dependence is comparable/inferior to a combination treatment with azacitidine and an ESA (that is if 5-azacytidine can overcome the resistance towards ESA). Being a phase II study, the study assesses, duration of erythroid response, overall survival and time to progression as well as toxicity.

ReferenceCitation: Thépot S, Ben Abdelali R, Chevret S, Renneville A, Beyne-Rauzy O, Prébet T, Park S, Stamatoullas A, Guerci-Bresler A, Cheze S, Tertian G, Choufi B, Legros L, Bastié JN, Delaunay J, Chaury MP, Sanhes L, Wattel E, Dreyfus F, Vey N, Chermat F, Preudhomme C, Fenaux P, Gardin C; Groupe Francophone des Myélodysplasies (GFM). A randomized phase II trial of azacitidine +/- epoetin-β in lower-risk myelodysplastic syndromes resistant to erythropoietic stimulating agents. Haematologica. 2016 Aug;101(8):918-25. doi: 10.3324/haematol.2015.140988. Epub 2016 May 26.

family: Thepot

full_name: S. Thepot

family: Ben Abdelali

full_name: R. Ben Abdelali

family: Chevret

full_name: S. Chevret

family: Renneville

full_name: A. Renneville

family: Beyne-Rauzy

full_name: O. Beyne-Rauzy

family: Prebet

full_name: T. Prebet

given: T.

family: Park

full_name: S. Park

family: Stamatoullas

full_name: A. Stamatoullas

family: Guerci-Bresler

full_name: A. Guerci-Bresler

family: Cheze

full_name: S. Cheze

family: Tertian

full_name: G. Tertian

given: G.

family: Choufi

full_name: B. Choufi

family: Legros

full_name: L. Legros

family: Bastie

full_name: J. N. Bastie

given: J. N.

family: Delaunay

full_name: J. Delaunay

family: Chaury

full_name: M. P. Chaury

given: M. P.

family: Sanhes

full_name: L. Sanhes

family: Wattel

full_name: E. Wattel

given: E.

family: Dreyfus

full_name: F. Dreyfus

given: F.

family: Vey

full_name: N. Vey

given: N.

family: Chermat

full_name: F. Chermat

family: Preudhomme

full_name: C. Preudhomme

family: Fenaux

full_name: P. Fenaux

given: P.

family: Gardin

name: on behalf of the Groupe Francophone des Myelodysplasies (GFM)

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

title: A randomized phase II trial of azacitidine +/- epoetin- in lower-risk myelodysplastic syndromes resistant to erythropoietic stimulating agents

location_facility:
Hôpital Edouard Herriot
Hôpital Saint Vincent
Hôpital Purpan
Hôpital de la Côte Basque
CHU d'Amiens
Hôpital La Source
Hôpital Jean-Bernard
Hôpital kremlin Bicêtre
Hopital Avicenne
Hôpital Saint Antoine
Hôpital Henri Becquerel
Hôpital Maréchal Joffre
Hôpital Archet1
Hôpital Boulogne Sur Mer
Hôpital Lariboisière
Hopital Clémenceau
Hôpital Reims
Hôpital Paoli-Calmettes
Hôpital Avignon
Hôpital Huriez
Hôpital Cochin
Hôpital Versailles
Hôpital Saint Louis
Hôpital Limoges
Hôpital Brabois
Hôpital Hôtel Dieu
Hôpital Angers
Hôpital Hautepierre
Hôpital le Bocage