ReferenceCitation: Pérez-García JM, Gebhart G, Ruiz Borrego M, Stradella A, Bermejo B, Schmid P, Marmé F, Escrivá-de-Romani S, Calvo L, Ribelles N, Martinez N, Albacar C, Prat A, Dalenc F, Kerrou K, Colleoni M, Afonso N, Di Cosimo S, Sampayo-Cordero M, Malfettone A, Cortés J, Llombart-Cussac A; PHERGain steering committee and trial investigators. Chemotherapy de-escalation using an (18)F-FDG-PET-based pathological response-adapted strategy in patients with HER2-positive early breast cancer (PHERGain): a multicentre, randomised, open-label, non-comparative, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):858-871. doi: 10.1016/S1470-2045(21)00122-4. Epub 2021 May 18.

family: Pérez-García

full_name: José Manuel Pérez-García

given: José Manuel

family: Gebhart

full_name: Geraldine Gebhart

given: Geraldine

family: Ruiz Borrego

full_name: Manuel Ruiz Borrego

given: Manuel

family: Stradella

full_name: Agostina Stradella

given: Agostina

family: Bermejo

full_name: Begoña Bermejo

given: Begoña

family: Schmid

full_name: Peter Schmid

given: Peter

family: Marmé

full_name: Frederik Marmé

given: Frederik

family: Escrivá-de-Romani

full_name: Santiago Escrivá-de-Romani

given: Santiago

family: Calvo

full_name: Lourdes Calvo

given: Lourdes

family: Ribelles

full_name: Nuria Ribelles

given: Nuria

family: Martinez

full_name: Noelia Martinez

given: Noelia

family: Albacar

full_name: Cinta Albacar

given: Cinta

family: Prat

full_name: Aleix Prat

given: Aleix

family: Dalenc

full_name: Florence Dalenc

given: Florence

family: Kerrou

full_name: Khaldoun Kerrou

given: Khaldoun

family: Colleoni

full_name: Marco Colleoni

given: Marco

family: Afonso

full_name: Noemia Afonso

given: Noemia

family: Di Cosimo

full_name: Serena Di Cosimo

given: Serena

family: Sampayo-Cordero

full_name: Miguel Sampayo-Cordero

given: Miguel

family: Malfettone

full_name: Andrea Malfettone

given: Andrea

family: Cortés

full_name: Javier Cortés

given: Javier

family: Llombart-Cussac

full_name: Antonio Llombart-Cussac

given: Antonio

journal_name: The Lancet Oncology

title: Chemotherapy de-escalation using an 18F-FDG-PET-based pathological response-adapted strategy in patients with HER2-positive early breast cancer (PHERGain): a multicentre, randomised, open-label, non-comparative, phase 2 trial

location_country:
Italy
Spain
France
Belgium
Portugal
Germany
United Kingdom

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital Clínic Universitari de Valencia

location_facility: Centro Hospitalaer de Tras-os-Montes e Alto Douro

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Clinical of Nuclear Medicine Technical University Munich

location_facility: Hospital General Universitari de Valencia

location_facility: Hospital Clínic i Provincial de Barcelona

title: Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive (Human Epidermal Receptor) Breast Cancer: FDG-PET Response-adapted Strategy. The PHERGain Study

summary:
The study assess the early metabolic effects of neoadjuvant treatment with trastuzumab and pertuzumab (± endocrine therapy) on the primary tumor and axillary lymph nodes and their predictive value for pathologic complete response (pCR) in the breast and axilla.

And also assess 3-year invasive disease-free survival (iDFS) in patients with HER2-positive (HER: human epidermal receptor) breast cancer treated with neoadjuvant trastuzumab and pertuzumab (± endocrine therapy) using a FDG-PET response-adapted strategy.


type: EudraCT Number

title: Phase I Dose-escalation of S 95005 (TAS-102) in Combination With Oxaliplatin in Metastatic Colorectal Cancer

summary: The main purpose of this study is to assess the safety and tolerability and to determine the recommended phase 2 dose of S 95005 given in combination with oxaliplatin in patients with metastatic colorectal cancer.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Argilés G, André T, Hollebecque A, Calvo A, Dahan L, Cervantes A, Leger C, Amellal N, Fougeray R, Tabernero J. Phase I dose-escalation of trifluridine/tipiracil in combination with oxaliplatin in patients with metastatic colorectal cancer. Eur J Cancer. 2019 May;112:12-19. doi: 10.1016/j.ejca.2019.01.101. Epub 2019 Mar 16.

family: Argilés

full_name: Guillem Argilés

given: Guillem

sequence: first

family: André

full_name: Thierry André

given: Thierry

sequence: additional

family: Hollebecque

full_name: Antoine Hollebecque

given: Antoine

full_name: Aitana Calvo

given: Aitana

family: Dahan

full_name: Laetitia Dahan

given: Laetitia

family: Cervantes

full_name: Andrés Cervantes

given: Andrés

family: Leger

full_name: Catherine Leger

given: Catherine

family: Amellal

full_name: Nadia Amellal

given: Nadia

family: Fougeray

full_name: Ronan Fougeray

given: Ronan

family: Tabernero

full_name: Josep Tabernero

given: Josep

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ipd_sharing: Yes

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Italy
Austria
France
Hungary
Spain
Germany
United Kingdom

location_facility: Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III

location_facility: Universitätsklinikum Ulm Zentrum für Innere Medizin, Klinik für Innere Medizin I

location_facility: H. Univ. Ramon y Cajal - Servicio de Oncología Medica

location_facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai O. Es Klin. Farmakologiai O.

location_facility: Hospital Unviersitario Gregorio Marañon - Servicio de Oncología Médica

location_facility: Klinikum Wolfsburg Medizinische Klinik II

location_facility: H. Clinico de Valencia INCLIVA - Departamento de Hematologia y Oncologia Medica 8ª planta

location_facility: Policlinico G.B. Rossi A.O.U.I. di Verona U.O.C. di Oncologia

location_facility: ARNAS - Azienda Ospedaliera Garibaldi - Nesima Struttura Complessa di Oncologia Medica

location_facility: ICO Badalona. H. Germans Trials y Pujol - Servicio de Oncología médica

location_facility: Hôpital Saint-Antoine Service d'Oncologie Médicale

location_facility: Centre Eugène Marquis Service d'Oncologie Médicale

location_facility: Ist.Scientifico Romagnolo per lo Studio e la Cura dei Tumori Department of Clinical Oncology

location_facility: Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie

location_facility: Universitätsklinikum Hamburg-Eppendorf II. Medizin. Klinik und Poliklinik (Onkologie, Hämatologie)

location_facility: H. Valle de Hebrón - Servicio de Oncología - (VHIR)

location_facility: La Pitié Salpêtrière Centre Investigation clinique Paris Est

location_facility: Semmelweis Egyetem I. sz. Belgyogyaszati Klinika - Klin. Farmakologiai Reszleg

location_facility: Christie Hospital NHS Foundation Trust GI & Endocrine

location_facility: St. Josef-Hospital, Klinikum der Ruhr-Universität Bochum Abteilung für Hämatologie und Onkologie

location_facility: H. Uni. Madrid Sanchinarro - CIOCC Servicio de Oncología

location_facility: CHU de la Timone Hépato-Gastro-Entérologie - Oncology Digestive

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Age-adjusted D-dimer Cut-off to Rule Out Pulmonary Embolism in the Emergency Department : A Real Life Impact Study

acronym: RELAX-PE

summary:
A multicentre multinational prospective management outcome study has recently proven the safety of a diagnostic strategy combining clinical probability assessment with an age-adjusted D-dimer cut-off, defined as a value of (age x 10) in patients > 50 years, for ruling out PE in outpatients, with a very low likelihood of subsequent symptomatic VTE. Moreover, this study showed that such a strategy increased the diagnostic yield of D-dimers, as it allowed ruling out PE without further investigation in a significantly higher proportion of patients than when using standard cut-off, particularly so in patients 75 years or older.

The objective of the present study is to confirm in a prospective cohort of "real life" patients the usefulness of the age-adjusted D-dimer cut-off to rule out PE in patients presenting to the emergency department with suspected PE.

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Righini M, Van Es J, Den Exter PL, Roy PM, Verschuren F, Ghuysen A, Rutschmann OT, Sanchez O, Jaffrelot M, Trinh-Duc A, Le Gall C, Moustafa F, Principe A, Van Houten AA, Ten Wolde M, Douma RA, Hazelaar G, Erkens PM, Van Kralingen KW, Grootenboers MJ, Durian MF, Cheung YW, Meyer G, Bounameaux H, Huisman MV, Kamphuisen PW, Le Gal G. Age-adjusted D-dimer cutoff levels to rule out pulmonary embolism: the ADJUST-PE study. JAMA. 2014 Mar 19;311(11):1117-24. doi: 10.1001/jama.2014.2135. Erratum in: JAMA. 2014 Apr 23-30;311(16):1694.

name: Division of Angiology and Hemostasis, Geneva University Hospital, Geneva, Switzerland

family: Righini

full_name: Marc Righini

given: Marc

name: Department of Vascular Medicine, Amsterdam Medical Center, Amsterdam, the Netherlands

family: Van Es

full_name: Josien Van Es

given: Josien

name: Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands

family: Den Exter

full_name: Paul L. Den Exter

given: Paul L.

name: Emergency Department, Centre Hospitalier Universitaire d’Angers, L'Université Nantes Angers Le Mans, Angers, France

family: Roy

full_name: Pierre-Marie Roy

given: Pierre-Marie

name: Cliniques Universitaires Saint-Luc, Bruxelles, Belgium

family: Verschuren

full_name: Franck Verschuren

given: Franck

name: Liège University Hospital, Liège, Belgium

family: Ghuysen

full_name: Alexandre Ghuysen

given: Alexandre

name: Emergency Department, Geneva University Hospital, Geneva, Switzerland

family: Rutschmann

full_name: Olivier T. Rutschmann

given: Olivier T.

name: Hôpital Européen Georges-Pompidou, Paris, France

family: Sanchez

full_name: Olivier Sanchez

given: Olivier

name: Emergency Department, Brest University Hospital, Brest, France

family: Jaffrelot

full_name: Morgan Jaffrelot

given: Morgan

family: Trinh-Duc

full_name: Albert Trinh-Duc

given: Albert

name: Centre Hospitalier d’Argenteuil, Argenteuil, France

family: Le Gall

full_name: Catherine Le Gall

name: Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France

family: Moustafa

full_name: Farès Moustafa

given: Farès

name: Centre Hospitalier de Morlaix, Morlaix, France

family: Principe

full_name: Alessandra Principe

given: Alessandra

name: Department of Internal Medicine, Maasstad Hospital, Rotterdam, the Netherlands

family: Van Houten

full_name: Anja A. Van Houten

given: Anja A.

name: Department of Internal Medicine, Flevoziekenhuis Hospital, Almere, the Netherlands

family: Ten Wolde

full_name: Marije Ten Wolde

given: Marije

family: Douma

full_name: Renée A. Douma

given: Renée A.

name: Rijnstate Hospital, Arnhem, the Netherlands

family: Hazelaar

full_name: Germa Hazelaar

given: Germa

name: Maastricht University Medical Center, Maastricht, the Netherlands

family: Erkens

full_name: Petra M. G. Erkens

given: Petra M. G.

name: Van Weel-Bethesda Hospital, Dirksland, the Netherlands

family: Van Kralingen

full_name: Klaas W. Van Kralingen

given: Klaas W.

family: Grootenboers

full_name: Marco J. J. H. Grootenboers

given: Marco J. J. H.

name: Department of Hematology, Erasmus University Medical Center, Rotterdam, the Netherlands

family: Durian

full_name: Marc F. Durian

given: Marc F.

family: Cheung

full_name: Y. Whitney Cheung

given: Y. Whitney

family: Meyer

full_name: Guy Meyer

given: Guy

family: Bounameaux

name: Department of Vascular Medicine, University Medical Center Groningen, Groningen, the Netherlands

name: Ottawa Health Research Institute, Ottawa, Canada23Centre d’Investigations Cliniques, Université de Brest, Brest, France

repository_institution: University of Geneva - Archive ouverte UNIGE

title: Age-Adjusted D-Dimer Cutoff Levels to Rule Out Pulmonary Embolism

ReferenceCitation: Robert-Ebadi H, Robin P, Hugli O, Verschuren F, Trinh-Duc A, Roy PM, Schmidt J, Fumeaux T, Meyer G, Hayoz D, Carron PN, Salaun PY, Sarasin F, Rutschmann O, Le Gal G, Righini M. Impact of the Age-Adjusted D-Dimer Cutoff to Exclude Pulmonary Embolism: A Multinational Prospective Real-Life Study (the RELAX-PE Study). Circulation. 2021 May 4;143(18):1828-1830. doi: 10.1161/CIRCULATIONAHA.120.052780. Epub 2021 May 3.

name: Division of Angiology and Hemostasis, Geneva University Hospitals and Faculty of Medicine, Switzerland (H.R.-E., M.R.).

name: Service de Médecine Nucléaire, EA 3878 (GETBO), Centre Hospitalier Régional et Universitaire de Brest, Université de Bretagne Occidentale, France (P.R., P.-Y.S.).

name: Emergency Department, Lausanne University Hospital and University of Lausanne, Switzerland (O.H., P.-N.C.).

name: Department of Acute Medicine, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Institute of Experimental and Clinical Research, Brussels, Belgium (F.V.).

name: Centre Hospitalier d’Agen, France (A.T.-D.).

name: Emergency Department, Centre Hospitalier Universitaire d’Angers, Institut MIOVASC, UMR (CNRS 6015–INSERM 1083), Université d’Angers, France (P.-M.R.).

name: Centre Hospitalier Universitaire de Clermont- Ferrand, France (J.S.).

name: Hôpital de Nyon, Groupe Hospitalier de l’Ouest Lémanique, Nyon, Switzerland (T.F.).

name: Hôpital Européen Georges Pompidou, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, INSERM UMR S 970, France (G.M.).

name: Hôpital Cantonal de Fribourg, Switzerland (D.H.).

name: Emergency Department, Geneva University Hospitals, Switzerland (F.S., O.R.).

name: Ottawa Health Research Institute, ON, Canada (G.L.G.).

publisher: Ovid Technologies (Wolters Kluwer Health)

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Groupement Hospitalier de l'Ouest Lémanique


title: A Prospective, Multi-center, Open-label, Single-arm, Phase 2 Study to Assess the Efficacy and Safety of Clazosentan in Reversing Angiographically-confirmed Cerebral Vasospasm in Adult Subjects With Aneurysmal Subarachnoid Hemorrhage (aSAH) Treated by Surgical Clipping or Endovascular Coiling

acronym: REVERSE

summary: The purpose of this study is to evaluate the safety and potential therapeutic benefit of use of clazosentan in reversing cerebral vasospasm (a narrowing of blood vessels in the brain due to the presence of blood in the space around the brain) in patients who have suffered a condition known as aneurysmal subarachnoid hemorrhage caused by bleeding onto the surface of the brain from a ruptured brain aneurysm

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country: Finland France Switzerland

location_facility:
Site 3003
Site 2002
Site 1001
Site 1006
Site 3001
Site 1005
Site 1002
Site 1004
Site 3005
Site 3004
Site 3002


summary:
Objectives:

Primary Objective:

To identify and preselect patients with chronic HBV mono infection, who are undetectable for anti-Ad5 nAb, currently being treated with nucleo(t)sides, for participation in the TG1050.02 Phase1/1b First in Man (FIM) study.

Secondary Objectives:

To assess the prevalence of undetectable anti-Ad5 nAb in chronic HBV mono-infected patients.

Methodology:

Patients with chronic HBV mono-infection, who are currently being treated with nucleo(t)sides for their HBV infection, will be enrolled in this study to measure Ad5 nAb levels. A single peripheral blood collection (4 mL) will be obtained and Ad5 nAb titers will be measured by a central laboratory using a newly validated assay.

primary_purpose: Screening

lead_sponsor: Transgene

location_country: Germany Canada France

intervention_type: Other


ReferenceCitation: Kersten MJ, Driessen J, Zijlstra JM, Plattel WJ, Morschhauser F, Lugtenburg PJ, Brice P, Hutchings M, Gastinne T, Liu R, Burggraaff CN, Nijland M, Tonino SH, Arens AIJ, Valkema R, van Tinteren H, Lopez-Yurda M, Diepstra A, De Jong D, Hagenbeek A. Combining brentuximab vedotin with dexamethasone, high-dose cytarabine and cisplatin as salvage treatment in relapsed or refractory Hodgkin lymphoma: the phase II HOVON/LLPC Transplant BRaVE study. Haematologica. 2021 Apr 1;106(4):1129-1137. doi: 10.3324/haematol.2019.243238.

family: Marie José Kersten

full_name: Marie José Kersten

family: Julia Driessen

full_name: Julia Driessen

family: Josée M. Zijlstra

full_name: Josée M. Zijlstra

family: Wouter J. Plattel

full_name: Wouter J. Plattel

family: Franck Morschhauser

full_name: Franck Morschhauser

family: Pieternella J. Lugtenburg

full_name: Pieternella J. Lugtenburg

family: Pauline Brice

full_name: Pauline Brice

family: Martin Hutchings

full_name: Martin Hutchings

family: Thomas Gastinne

full_name: Thomas Gastinne

family: Roberto Liu

full_name: Roberto Liu

family: Coreline N. Burggraaff

full_name: Coreline N. Burggraaff

family: Marcel Nijland

full_name: Marcel Nijland

family: Sanne H. Tonino

full_name: Sanne H. Tonino

family: Anne I.J. Arens

full_name: Anne I.J. Arens

family: Roelf Valkema

full_name: Roelf Valkema

family: Harm van Tinteren

full_name: Harm van Tinteren

family: Marta Lopez-Yurda

full_name: Marta Lopez-Yurda

family: Arjan Diepstra

full_name: Arjan Diepstra

family: Daphne De Jong

full_name: Daphne De Jong

family: Anton Hagenbeek

full_name: Anton Hagenbeek

currency_apc_doaj: EUR

journal_name: Haematologica

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: publisher-specific license

license_normalized: publisher-specific

version: publishedVersion

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

publisher: Ferrata Storti Foundation (Haematologica)

status: Unknown status

lead_sponsor: Marjolein Spiering

enrollment_type: Anticipated

location_country:
Denmark
United Kingdom
France
Netherlands

acronym: Transplant BRaVE

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Cambridge University Hospitals NHS Foundation Trust | Addenbrooke's Hospital

study_completion_date_type: Anticipated

type: Other Identifier

title: Phase I/II Feasibility Study Combining Brentuximab Vedotin With Second Line Salvage Chemotherapy (DHAP) in Hodgkin Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse Who Are Eligible for High Dose Treatment Followed by Autologous Peripheral Blood Stem Cell Transplantation (ASCT)

summary: To combine Brentuximab Vedotin with Dexamethasone, AraC and Cisplatin (DHAP) chemotherapy in patients with Hodgkin lymphoma (HL) refractory to first line chemotherapy or in first relapse is expected to induce a significantly higher (metabolic) complete remission (CR) rate prior to consolidation with BEAM, as judged by FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose)-PET negativity. This will be compared with published data on DHAP salvage only. Increasing the metabolic CR rate prior to consolidation with high dose chemotherapy and autologous stem cell transplantation (ASCT) is expected to improve progression free survival (PFS) and overall survival (OS).


title: A Collaborative Retrospective Trial on the Efficacy and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients With Diabetic Macular Edema (DME). THE EUROPEAN DME REGISTRAR STUDY (ARTES)

acronym: ARTES

summary: To review the safety and efficacy of injections with Ozurdex (700 μg dexamethasone) in clinical practice management of patients with DME.

time_perspective: Retrospective

location_country:
Italy
Sweden
Spain
Finland
France
Israel
Portugal
United Kingdom

location_facility: Department of Ophthalmology Tel Aviv Sourasky Medical Center

location_facility: Excellence Eye Research Centre University G. d'Annunzio of Chieti-Pescara

location_facility: Ophthalmology Department, Dos de Maig Hospital

location_facility: Department of Ophthalmology Lariboisière Hospital

location_facility: Department of Ophthalmology, Croix Rousse University Hospital

location_facility: Department of Ophthalmology University Vita Salute - Scientific Institute of San Raffael

location_facility: Ophthalmology Department, Kaplan Medical Center

location_facility: Instituto de Retina e Diabetes Ocular de Lisboa (IRL)

location_facility: Ophthalmic Research Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs

location_facility: Department of Ophthalmology, Centre Hospitalier Henri Duffaut,

location_facility: Servicio de Oftalmologia, Hospital Universitario Y Politecnico de la Fe

location_facility: Department of Ophthalmology University of Udine

location_facility: Ophthalmology Clinical Trials Unit Frimley Park Hospital Foundation Trust

location_facility: Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image

location_facility: Department of Ophthalmology, Kuopio University Hospital

location_facility: Clinical Trial Unit, Department of Ophthalmology, CHU Nord, Aix Marseille University

location_facility: NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, NHS Foundation Trust

location_facility: Ophthalmology Department, Hospital de LaPaz

location_facility: Centre for Clinical Trials, Department of Ophthalmology University of Padova

location_facility: Hospital Vall d'Hebrón Department of Ophthalmology


title: Nanostim Study for a Leadless Cardiac Pacemaker System

summary: The objective of the study is to confirm clinical performance and safety of the Nanostim leadless cardiac pacemaker system within its intended use and according to its instructions for use.

status: Active, not recruiting

ReferenceCitation: Reddy VY, Miller MA, Knops RE, Neuzil P, Defaye P, Jung W, Doshi R, Castellani M, Strickberger A, Mead RH, Doppalapudi H, Lakkireddy D, Bennett M, Sperzel J. Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience. Circ Arrhythm Electrophysiol. 2016 Dec;9(12). pii: e004626.

lead_sponsor: Abbott Medical Devices

location_country:
Italy
Netherlands
France
Czechia
Spain
Germany
United Kingdom

location_facility: Universitätsmedizin Berlin - Campus Benjamin Franklin

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: Manchester Heart Center, Manchester Royal Infirmary

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

intervention_type: Device

status_simplified: Ongoing


title: WEB Clinical Assessment of IntraSaccular Aneurysm Therapy

acronym: WEBCAST

summary: The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms

ReferenceCitation: Pierot L, Szikora I, Barreau X, Holtmannspoetter M, Spelle L, Herbreteau D, Fiehler J, Costalat V, Klisch J, Januel AC, Weber W, Liebig T, Stockx L, Berkefeld J, Moret J, Molyneux A, Byrne J. Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up. J Neurointerv Surg. 2021 Apr;13(4):363-368. doi: 10.1136/neurintsurg-2020-016151. Epub 2020 Jun 12.

family: Pierot

full_name: Laurent Pierot

given: Laurent

family: Szikora

full_name: Istvan Szikora

given: Istvan

family: Barreau

full_name: Xavier Barreau

given: Xavier

family: Holtmannspoetter

full_name: Markus Holtmannspoetter

given: Markus

family: Spelle

full_name: Laurent Spelle

family: Herbreteau

full_name: Denis Herbreteau

given: Denis

family: Fiehler

full_name: Jens Fiehler

given: Jens

family: Costalat

full_name: Vincent Costalat

given: Vincent

family: Klisch

full_name: Joachim Klisch

given: Joachim

family: Januel

full_name: Anne-Christine Januel

given: Anne-Christine

family: Weber

full_name: Werner Weber

given: Werner

family: Liebig

full_name: Thomas Liebig

given: Thomas

family: Stockx

full_name: Luc Stockx

given: Luc

family: Berkefeld

full_name: Joachim Berkefeld

family: Moret

full_name: Jacques Moret

given: Jacques

family: Molyneux

full_name: Andy Molyneux

given: Andy

family: Byrne

full_name: James Byrne

given: James

journal_name: Journal of NeuroInterventional Surgery

oa_colors: green hybrid

evidence: open (via page says license)

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Pierot L, Spelle L, Molyneux A, Byrne J; WEBCAST and French Observatory Investigators. Clinical and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device: 1-Year Follow-up Report in the Cumulated Population of 2 Prospective, Multicenter Series (WEBCAST and French Observatory). Neurosurgery. 2016 Jan;78(1):133-41. doi: 10.1227/NEU.0000000000001106.

name: Department of Neuroradiology, Maison Blanche Hospital, University of Reims-Champagne-Ardenne, France

name: Department of Interventional Neuroradiology, CHU Kremlin-Bicêtre, Kremlin Bicêtre, France

name: Oxford Neurovascular & Neuroradiology Research Unit, Oxford Radcliffe Hospital, Oxford, United Kingdom

location_facility: Klinikum der Johann Wolfgang Goethe Universität


title: Open-Label, Multi-Center, Phase 2 Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) in Subjects With Previously Treated Peripheral T-cell Lymphoma (PTCL)

summary: The primary objective of this study is to determine the overall response rate of KW-0761 for the treatment of patients with relapsed or refractory PTCL. KW-0761 targets CCR4. CCR4 is the receptor for macrophage derived chemokines MDC/CCL22 and TARC/CCL17. Chemokines are considered to play a role both in the recruitment of immune and inflammatory cells for anti-tumor response and in the selective homing of neoplastic B and T cells.

ReferenceCitation: Zinzani PL, Karlin L, Radford J, Caballero D, Fields P, Chamuleau ME, d'Amore F, Haioun C, Thieblemont C, González-Barca E, García CG, Johnson PW, van Imhoff GW, Ng T, Dwyer K, Morschhauser F. European phase II study of mogamulizumab, an anti-CCR4 monoclonal antibody, in relapsed/refractory peripheral T-cell lymphoma. Haematologica. 2016 Oct;101(10):e407-e410. Epub 2016 Jul 14.

lead_sponsor: Kyowa Hakko Kirin Pharma, Inc.

location_country:
Italy
Netherlands
France
Spain
Denmark
United Kingdom

location_facility: Institut Catalá D'Oncologia, Hospital Duran y Reynals

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Cancer Research UK Centre/Southhampton General Hospital

location_facility: Universitair Medisch Centrum Groningen (UMCG)

intervention_type: Biological


title: DOVIGIST: Phase II Trial to Evaluate the Efficacy and Safety of Dovitinib (TKI258) in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib

summary: The purpose of this study is to evaluate the efficacy and safety of Dovitinib in patients with gastrointestinal stromal tumors refractory and/or intolerant to Imatinib

lead_sponsor: Novartis Pharmaceuticals

location_country: Italy Finland France Spain Germany


ReferenceCitation: Campone M, Berton-Rigaud D, Joly-Lobbedez F, Baurain JF, Rolland F, Stenzl A, Fabbro M, van Dijk M, Pinkert J, Schmelter T, de Bont N, Pautier P. A double-blind, randomized phase II study to evaluate the safety and efficacy of acetyl-L-carnitine in the prevention of sagopilone-induced peripheral neuropathy. Oncologist. 2013;18(11):1190-1. doi: 10.1634/theoncologist.2013-0061. Epub 2013 Oct 8.

name: Institut de Cancérologie de l'Ouest – René Gauducheau Centre de Recherche en Cancérologie, Nantes, France;

family: Campone

full_name: Mario Campone

given: Mario

family: Berton‐Rigaud

full_name: Dominique Berton‐Rigaud

given: Dominique

family: Joly‐Lobbedez

full_name: Florence Joly‐Lobbedez

given: Florence

name: Cancer Centre, Brussels Saint‐Luc University Hospital, Brussels, Belgium;

family: Baurain

full_name: Jean‐Francois Baurain

given: Jean‐Francois

family: Rolland

full_name: Frédéric Rolland

given: Frédéric

name: University Hospital Tübingen, Tübingen, Germany;

family: Stenzl

full_name: Arnulf Stenzl

given: Arnulf

name: Centre Val d'Aurelle – Paul Lamarque, Montpellier, France;

family: Fabbro

full_name: Michel Fabbro

given: Michel

name: Department of Medical Oncology, Maastricht Teaching Hospital, Maastricht, The Netherlands;

family: Dijk

full_name: Marjan Dijk

given: Marjan

name: Bayer HealthCare Pharmaceuticals, Leverkusen, Germany;

family: Pinkert

full_name: Jörg Pinkert

given: Jörg

family: Schmelter

full_name: Thomas Schmelter

name: Bayer HealthCare Pharmaceuticals, Mijdrecht, The Netherlands;

family: Bont

full_name: Natasja Bont

given: Natasja

name: Institut Gustave Roussy, Villejuif, France

family: Pautier

full_name: Patricia Pautier

given: Patricia

journal_name: The Oncologist

oa_host_type: repository

repository_institution: PubMed Central - Europe PMC

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: A Double‐Blind, Randomized Phase II Study to Evaluate the Safety and Efficacy of Acetyl‐L‐Carnitine in the Prevention of Sagopilone‐Induced Peripheral Neuropathy

design_allocation: Randomized

lead_sponsor: Bayer

location_country:
Italy
Netherlands
France
Belgium
Germany
United Kingdom

acronym: REASON

source: euctr

title: (REASON) Double-blind, Randomized Phase II Study to Evaluate the Safety and Efficacy of Acetyl-l-carnitine in the Prevention of Sagopilone-induced Peripheral Neuropathy.

summary: This study investigates the safety and efficacy of Acetyl-L-Carnitine and compares it to the safety and efficacy of a placebo (inactive) tablet in the prevention of Sagopilone-induced peripheral neuropathy. Patients will receive intravenous infusion of sagopilone for 3 hours on day 1 of a 3-weeks cycle. Treatment with Sagopilone will be given as long as the patient is benefitting. In addition patients will receive ALC or placebo, starting 1 week before first sagopilone infusion and ending 30-33 days after the last infusion with sagopilone. Safety will be determined by laboratory and other evaluations. Efficacy of ALC will be determined by the incidence of all grades of peripheral neuropathy with the results of a patient questionnaire. Efficacy of the combination of ALC and Sagopilone will be determined by the tumor response.


title: Prospective, Open-Label, Non-Comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) With Voriconazole in Patients With Allogeneic Stem Cell Transplants (SCT).

acronym: VOSIFI

summary: To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants

design_allocation: Non-Randomized

primary_purpose: Prevention

lead_sponsor: Pfizer

location_country:
Sweden
Switzerland
France
Belgium
Spain
Germany
United Kingdom
Portugal


title: Randomized Phase II of TARCEVA™ (Erlotinib) Versus Temozolomide Or BCNU in Patients With Recurrent Glioblastoma Multiforme

summary:
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide and carmustine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether erlotinib is more effective than temozolomide or carmustine in treating recurrent glioblastoma multiforme.

PURPOSE: This randomized phase II trial is studying erlotinib to see how well it works compared to temozolomide or carmustine in treating patients with recurrent glioblastoma multiforme.

ReferenceType: result

ReferenceCitation: van den Bent MJ, Brandes AA, Rampling R, Kouwenhoven MC, Kros JM, Carpentier AF, Clement PM, Frenay M, Campone M, Baurain JF, Armand JP, Taphoorn MJ, Tosoni A, Kletzl H, Klughammer B, Lacombe D, Gorlia T. Randomized phase II trial of erlotinib versus temozolomide or carmustine in recurrent glioblastoma: EORTC brain tumor group study 26034. J Clin Oncol. 2009 Mar 10;27(8):1268-74. doi: 10.1200/JCO.2008.17.5984. Epub 2009 Feb 9.

name: From the Daniel den Hoed Cancer Center, Rotterdam; and Medisch Centrum Haaglanden, the Hague, the Netherlands; Medical Oncology Department, Bellaria-Maggiore Hospital, Bologna, Italy; Beatson Oncology Centre, Glasgow, United Kingdom; Hopital de la Salpêtrière, Paris; Centre Antoine Lacassagne, Nice; Centre Rene Gauducheau, Nantes, St. Herblain; and Institute Gustave Roussy, Villejuif Cedex, France; Medical Oncology, University Hospital Gasthuisberg, Leuven; Cliniques Universitaires St. Luc, Brussels; and...

family: van den Bent

full_name: Martin J. van den Bent

given: Martin J.

family: Brandes

full_name: Alba A. Brandes

given: Alba A.

family: Rampling

full_name: Roy Rampling

given: Roy

family: Kouwenhoven

full_name: Mathilde C.M. Kouwenhoven

given: Mathilde C.M.

family: Kros

full_name: Johan M. Kros

given: Johan M.

family: Carpentier

full_name: Antoine F. Carpentier

given: Antoine F.

family: Clement

full_name: Paul M. Clement

given: Paul M.

family: Frenay

full_name: Marc Frenay

given: Marc

full_name: Jean-Francois Baurain

given: Jean-Francois

family: Armand

full_name: Jean-Paul Armand

given: Jean-Paul

family: Taphoorn

full_name: Martin J.B. Taphoorn

given: Martin J.B.

family: Tosoni

full_name: Alicia Tosoni

given: Alicia

family: Kletzl

full_name: Heidemarie Kletzl

given: Heidemarie

family: Klughammer

full_name: Barbara Klughammer

given: Barbara

family: Lacombe

full_name: Denis Lacombe

given: Denis

family: Gorlia

full_name: Thierry Gorlia

given: Thierry

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Randomized Phase II Trial of Erlotinib Versus Temozolomide or Carmustine in Recurrent Glioblastoma: EORTC Brain Tumor Group Study 26034

ReferenceCitation: van den Bent MJ, Brandes A, Rampling R, et al.: Randomized phase II trial of erlotinib (E) versus temozolomide (TMZ) or BCNU in recurrent glioblastoma multiforme (GBM): EORTC 26034. [Abstract] J Clin Oncol 25 (Suppl 18): A-2005, 2007.

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

location_country:
Italy
Netherlands
France
Belgium
United Kingdom

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc


title: Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer

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

PURPOSE: Phase II trial to study the effectiveness of MEN-10755 in treating patients who have progressive prostate cancer that has not responded to hormone therapy.

ReferenceCitation: Fiedler W, Tchen N, Bloch J, Fargeot P, Sorio R, Vermorken JB, Collette L, Lacombe D, Twelves C; EORTC new drug development group. A study from the EORTC new drug development group: open label phase II study of sabarubicin (MEN-10755) in patients with progressive hormone refractory prostate cancer. Eur J Cancer. 2006 Jan;42(2):200-4. Epub 2005 Dec 7.

location_country: Switzerland France Israel Belgium Spain Germany

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


title: Open Label Phase II Study on RFS 2000 (9-Nitro-camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Advanced Ovarian Cancer

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

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced ovarian cancer.

location_country:
Italy
Switzerland
France
Israel
Belgium
Spain
United Kingdom


title: TRI-FR : Multicentric Randomized Evaluation of Tricuspid Valve Percutaneous Repair System (Clip for the Tricuspid Valve) in the Treatment of Severe Secondary Tricuspid Disorders

acronym: TRI-FR

summary:
Tricuspid regurgitation (TR) is a long-overdue valvular pathology. Its prevalence is significant and increasing with the aging of the population. It is often a consequence of chronic left cardiac pathologies or atrial fibrillation. Surgical treatment is recommended in severe symptomatic TR or when the tricuspid annulus is dilated with TR identified prior to scheduled left heart valve surgery. TR are mainly secondary (complicating left heart disease, pulmonary hypertension, atrial fibrillation and atrial dilatation) and pose a difficult problem related to the prognosis. The risk of death or hospitalization is high under medical treatment. Nevertheless, the surgical results are disappointing with significant morbidity and mortality, which are increased by associated comorbidities that are frequent in these sorts of patients. The benefit-risk assessment of surgery is limited by multiple confounders.

This justifies the evaluation of alternative methods aimed at correcting TR with less interventional risk.

The Clip for the tricuspid valve has been evaluated in the TRILUMINATE trial (inclusion of 85 patients with moderate-to-severe symptomatic TR with a 6-month follow-up). The Triclip system appears to be safe and effective at reducing tricuspid regurgitation by at least one grade. This reduction could translate to significant clinical improvement at 6 months post-procedure. It justified the European Conformity (CE) mark obtention.

A very similar system for the mitral valve (Mitraclip) was previously tested in the randomized EVEREST II study against conventional surgery. The results of the EVEREST II trial justified the recourse to percutaneous edge-to edge mitral repair in patients with primary mitral regurgitation when the patient is contraindicated to conventional surgery.

The Mitra-FR study made it possible to study the role of Mitraclip for treating patient suffering from a secondary mitral insufficiency. It leads to the implementation of this technique in selected patients.

For secondary TR, several series underscored its prevalence and its clinical consequences. TR treatment justifies the proposal for a randomized study. As a matter of fact, evidence for treating are seriously lacking. Surgical surveys report hospital mortality ~ 8.8%. It, therefore, seems necessary to conduct a study as robust as possible to evaluate the contribution of clip for the tricuspid valve (as an innovative percutaneous technique) compared to conventional pharmacological treatment in patients who are unsuitable for a surgical isolated correction of the TR and who has suitable anatomy for clip for the tricuspid valve. It will be necessary to demonstrate clinical, functional (quality of life), echocardiographic and biological benefit of the percutaneous treatment vs optimized medical treatment alone.

status: Recruiting

ReferenceCitation: Donal E, Leurent G, Iung B. Are We Right to Believe in the Value of Transcatheter Treatment of Secondary Tricuspid Regurgitation? J Am Coll Cardiol. 2021 Jan 26;77(3):240-242. doi: 10.1016/j.jacc.2020.11.037.

family: Donal

full_name: Erwan Donal

given: Erwan

family: Leurent

full_name: Guillaume Leurent

given: Guillaume

family: Iung

full_name: Bernard Iung

given: Bernard

journal_name: Journal of the American College of Cardiology

ipd_sharing: No

lead_sponsor: Rennes University Hospital

location_country: Belgium France

location_facility: CHU Nantes - Hôtel Dieu et Hôpital Nord Laennec

location_facility: Hospices Civils de Lyon Groupement Hospitalier EST

location_facility: CHU Bordeaux - Hôpital Cardiologique du Haut-Lévêque

lead_sponsor_type: academique


title: HOME-CoV: Hospitalization or Outpatient ManagEment of Patients With Confirmed or Probable SARS-CoV-2 Infection. A Before and After Implementation of a Consensus Help-decision Making Rule Study

acronym: HOME-CoV

summary:
COVID-19 pandemic has developed worldwide in less than 4 months. The clinical presentations are variable widely, ranging from simple rhinitis to major lung damage that can lead to death.

In many countries involved in the ongoing health disaster due to SARS-CoV-2 infection, hospital are overloaded. In this context, the decision to hospitalize or to manage COVID-19 patients at home is crucial and defining reliable and consensual criteria is a major issue.

HOME-CoV study is a multicentre quasi-experimental interventional study, before and after implementation of a help-decision making rule (HOME-CoV rule), developed via the Delphi method.

Our main hypothesis is that a strategy based on the consensual HOME-CoV rule compared to current practice is at least as safe as regards the 7-day-rate of adverse events (safety criterion) and more effective as regards the rate of patients eventually managed as outpatients (efficacy criterion).

ReferenceCitation: Douillet D, Penaloza A, Mahieu R, Morin F, Chauvin A, Gennai S, Schotte T, Montassier E, Thiebaud PC, Ghuysen François A, Dall'acqua D, Benhammouda K, Bissokele P, Violeau M, Joly LM, Andrianjafy H, Soulie C, Savary D, Riou J, Roy PM; Hospitalization or Outpatient Management of Patients With SARS-CoV-2 Infection Study Group. Outpatient Management of Patients With COVID-19: Multicenter Prospective Validation of the Hospitalization or Outpatient Management of Patients With SARS-CoV-2 Infection Rule to Discharge Patients Safely. Chest. 2021 Oct;160(4):1222-1231. doi: 10.1016/j.chest.2021.05.008. Epub 2021 May 15.

family: Douillet

full_name: Delphine Douillet

given: Delphine

family: Penaloza

full_name: Andrea Penaloza

given: Andrea

family: Mahieu

full_name: Rafaël Mahieu

given: Rafaël

family: Morin

full_name: François Morin

given: François

family: Chauvin

full_name: Anthony Chauvin

given: Anthony

family: Gennai

full_name: Stéphane Gennai

given: Stéphane

family: Schotte

full_name: Thibault Schotte

given: Thibault

family: Montassier

full_name: Emmanuel Montassier

given: Emmanuel

family: Thiebaud

full_name: Pierre-Clément Thiebaud

given: Pierre-Clément

family: Ghuysen François

full_name: Alexandre Ghuysen François

given: Alexandre

family: Dall’acqua

full_name: David Dall’acqua

given: David

family: Benhammouda

full_name: Kasarra Benhammouda

given: Kasarra

family: Bissokele

full_name: Pascal Bissokele

given: Pascal

family: Violeau

full_name: Mathieu Violeau

given: Mathieu

family: Joly

full_name: Luc-Marie Joly

given: Luc-Marie

family: Andrianjafy

full_name: Hery Andrianjafy

given: Hery

family: Soulie

full_name: Caroline Soulie

given: Caroline

family: Savary

full_name: Dominique Savary

given: Dominique

family: Riou

full_name: Jérémie Riou

given: Jérémie

family: Roy

full_name: Pierre-Marie Roy

given: Pierre-Marie

full_name: H. Andrianjafy

given: H.

family: Baudin

full_name: L. Baudin

given: L.

full_name: K. Benhammouda

given: K.

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

ReferenceCitation: Douillet D, Mahieu R, Boiveau V, Vandamme YM, Armand A, Morin F, Savary D, Dubée V, Annweiler C, Roy PM; HOME-CoV expert group. Outpatient management or hospitalization of patients with proven or suspected SARS-CoV-2 infection: the HOME-CoV rule. Intern Emerg Med. 2020 Nov;15(8):1525-1531. doi: 10.1007/s11739-020-02483-0. Epub 2020 Sep 4.

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

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

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

location_facility: Centre Hospitalier Universitaire de Nantes


ipd_sharing_description: Where patient data can be anonymized, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available

lead_sponsor: Ipsen

location_country:
Austria
Switzerland
Netherlands
France
Spain
Germany
United Kingdom

acronym: CaboPoint

location_facility: Royal Cornwall Hospital (RCH) - Sunrise Centre

location_facility: Caritas Krankenhaus St.Josef Klinik für Urologie

location_facility: Klinikum Der Friedrich-Schiller-Universitaet Jena

location_facility: University Cancer Center Hamburg Eppendorf

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: The Netherlands Cancer Institute - Oncology

location_facility: Otto-von-Guericke-Universität University hospital Magdeburg

location_facility: Western General Hospital - Edinburgh Cancer Centre

location_facility: CHU de Nîmes - Institut de Cancérologie du Gard

location_facility: University Hospital Carl Gustav Carus Dresden

title: A Phase II, Multicentre, Open-label Study of Cabozantinib as 2nd Line Treatment in Subjects With Unresectable, Locally Advanced or Metastatic Renal Cell Carcinoma With a Clear-Cell Component Who Progressed After 1st Line Treatment With Checkpoint Inhibitors.

summary: The overall objective of this study is to evaluate the efficacy and safety of cabozantinib as 2nd line treatment in subjects with unresectable, locally advanced or metastatic RCC with a clear-cell component, who progressed after prior Checkpoint Inhibitors (CPI) therapy with ipilimumab and nivolumab in combination or CPI combined with Vascular Endothelial Growth Factor (VEGF)-targeted therapy.


title: A Randomized Phase III Trial of Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab Versus Platinum Chemotherapy Plus Paclitaxel and Bevacizumab in Metastatic (Stage IVB), Persistent, or Recurrent Carcinoma of the Cervix

acronym: BEATcc

summary:
The study will integrate the efficacy of combining the anti programmed death-ligand 1 (anti-PD-L1) agent atezolizumab with the current standard of care in Stage IVB , persistent or recurrent carcinoma of the cervix, namely cisplatin or carboplatin/paclitaxel/bevacizumab. It will be explored the combination of bevacizumab plus atezolizumab, with no patient selection based on PD-L1 expression, allowing an all-comer assessment of atezolizumab activity.

The study is a randomized open label phase III trial to investigate the impact of atezolizumab in combination with bevacizumab and cisplatin or carboplatin /paclitaxel chemotherapy on overall survival and will employ the intent to treat principle, and random assignment to one of the 2 arms will be balanced according to disease histology (squamous cell carcinoma vs adenocarcinoma), prior platinum therapy as a radiation sensitizer (no prior cis-Radiotherapy (RT) versus prior cis-RT) and chemotherapy backbone (cisplatin vs carboplatin).

This trial will be run in an open label design due to the following considerations: the control arm is the standard of care for women diagnosed with metastatic, persistant or recurrent cervical cancer because of its impact on overall survival and the primary endpoint of the study is overall survival (OS), so blinding is not needed to ensure a robust assessment.

ReferenceCitation: Grau JF, Farinas-Madrid L, Oaknin A. A randomized phase III trial of platinum chemotherapy plus paclitaxel with bevacizumab and atezolizumab versus platinum chemotherapy plus paclitaxel and bevacizumab in metastatic (stage IVB), persistent, or recurrent carcinoma of the cervix: the BEATcc study (ENGOT-Cx10/GEICO 68-C/JGOG1084/GOG-3030). Int J Gynecol Cancer. 2020 Jan;30(1):139-143. doi: 10.1136/ijgc-2019-000880. Epub 2019 Oct 23.

family: Grau

full_name: Juan Francisco Grau

given: Juan Francisco

family: Farinas-Madrid

full_name: Lorena Farinas-Madrid

given: Lorena

family: Oaknin

full_name: Ana Oaknin

given: Ana

journal_name: International Journal of Gynecologic Cancer

lead_sponsor: Grupo Español de Investigación en Cáncer de Ovario

location_country:
Italy
United States
Sweden
France
Japan
Norway
Spain
Germany

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hospital Clinico Universitario Virgen Arrixaca

location_facility: Saitama medical university international medical center

location_facility: Azienda Sanitaria Universitaria Integrata Di Udine

location_facility: AUSL Romagna - P.O. di Ravenna, Lugo, Faenza, Rimini e Cattolica

location_facility: Groupe Hospitalier Diaconesses-Croix Saint-Simon

location_facility: Hosptial Clinico Universitario de Santiago de Compostela

location_facility: Complejo Hospitalario Regional de Málaga

location_facility: AOU Città della Salute e della Scienza di Torino, Presidio Sant'Anna

location_facility: Niigata University Medical & Dental Hospital

location_facility: Intitut Català d' Oncolgia L' Hospitalet

location_facility: Istituto Nazionale Tumori Di Napoli Irccs Pascale

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Hospital Universitario Donostia- Donostia Unibertsitate Ospitalea

location_facility: Azienda Ospedaliero-Universitaria Di Ferrara


status: Enrolling by invitation

lead_sponsor: Actelion

location_country:
Poland
France
Russian Federation
Belgium
Belarus
Ukraine

acronym: UMBRELLA

location_facility: Federal North-West Medical Research Centre

location_facility: CHU de Montpellier - Arnaud de Villeneuve

location_facility: GH est - Hôpital Cardiovasculaire et Pneumologie Louis Pradel

location_facility: Wojewodzki Szpital Specjalistyczny, Oddzial Kardiologiczny

location_facility: National Medical Research Center of Cardiology of MoH of Russian Federation

location_facility: Cardiovascular Pathology Research Institute of Siberian Branch of RAMS

location_facility: CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'

location_facility: Centre Hospitalier Universitaire - de Nice - Hopital Pasteur

location_facility: Minsk Regional Clinical Hospital Of The Red Banner Of Labor

location_facility: Hopital Bicêtre - Aphp Hôpitaux Universitaires Paris-Sud

location_facility: Federal State Budget Scientific Institution

title: mUlticenter, Single-arM, Open-laBel, Long-teRm Safety Study With macitEntan in Patients With puLmonary Arterial Hypertension previousLy Treated With mAcitentan in Clinical Studies

summary: The aim of the trial is to study the long-term safety of macitentan and to provide continued treatment with macitentan to patients with pulmonary arterial hypertension (PAH) and Chronic thromboembolic pulmonary hypertension (CTEPH) who were previously treated with macitentan in clinical studies.

status_simplified: Unknown


title: Combination of Targeted Therapy (Encorafenib and Binimetinib) Followed by Combination of Immunotherapy (Ipilimumab and Nivolumab) vs Immediate Combination of Immunotherapy in Patients With Unresectable or Metastatic Melanoma With BRAF V600 Mutation : an EORTC Randomized Phase II Study (EBIN)

acronym: EBIN

summary: This is a multicenter, 2-arm open-label, randomized comparative phase II study. The objective of this trial is to prospectively evaluate whether a sequential approach with an induction period of 12 weeks with encorafenib + binimetinib followed by combination immunotherapy with nivolumab + ipilimumab improves progression free survival compared to combination immunotherapy nivolumab + ipilimumab alone in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

ipd_sharing_description: All publications must comply with the terms specified in the EORTC Policy 009 "Release of Results and Publication Policy".

location_country:
Italy
Netherlands
France
Poland
Belgium
Spain
Germany
United Kingdom

location_facility: Univ. Mainz - Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center

location_facility: Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis

location_facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: East & North Hertfordshire NHS Trust - East and North Hertfordshire NHS Trust - Mount Vernon Hospital

location_facility: Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (APHM)

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: CHU de Grenoble - La Tronche - Hôpital A. Michallon

location_facility: CHU de Dijon - Centre Georges-François-Leclerc

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)


title: An Open Label Phase II Study to Evaluate the Efficacy and Safety of Induction and Consolidation Therapy With Dasatinib in Combination With Chemotherapy in Patients Aged 55 Years and Over With Philadelphia Chromosome Positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL).

summary:
The use of imatinib in combination or in association with chemotherapy is now considered as the gold standard for the treatment of Ph+ ALL. The complete remission (CR) rate is 90% versus 20% to 40% with chemotherapy alone. The combination of imatinib, vincristine and dexamethasone is a well tolerated regimen in aged patients and is also associated with a high CR rate of 80% to 90% in patient aged 55 years and over.
However, despite high CR rates, the progression free survival rate at 12 months of patients treated with the combination of imatinib and chemotherapy is 30% to 50%. Relapses remain frequent and only patients intensified with allogenic haematopoietic stem cell transplantation are in long term remission. This strategy is not fully applicable to most patients aged 55 years and over.
Relapses after or during imatinib therapy in patients with Ph+ ALL are associated with BCR-ABL tyrosine kinase domain mutation in 80% of cases, predominantly of the p-loop. The exact incidence of the T315I mutation is controversial and can be estimated to be near 50%. Conversely, the detection of the T315I or F317 mutation in a patient is a very strong predictor of relapse.
Dasatinib is a potent SCR and BCR-ABL tyrosine kinase inhibitor with preserved in vitro activity in most of the BCR-ABL mutated cell lines, except for the T315I and F317 mutations. This is also the case in vivo, with patients harbouring BCR-ABL TK domain mutations remaining sensitive to dasatinib. The CHR rate in Ph+ ALL resistant to imatinib is 33% and the median progression-free survival is 3.7 months. Progression free survival (PFS) rate at 12 months is 22%.

The goal of this trial is to evaluate the efficacy and the tolerance of the combination of dasatinib with chemotherapy in the front-line setting as induction and consolidation therapy in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be used in this trial with the addition of dasatinib as concomitant therapy during induction and alternating with chemotherapy during consolidation and maintenance. A CR rate of 90% and a progression free survival of 60% at 12 months are expected. The patients will be prospectively monitored for minimal residual disease and mutation.

lead_sponsor: Versailles Hospital

location_country: Italy Germany Belgium France

location_facility: Centre Hospitalier Départemental FELIX GUYON


title: Phase I/II Feasibility Study of Brentuximab Vedotin in Refractory / Relapsed Hodgkin Lymphoma Patients Who Are Treated by Chemotherapy (ICE) in Second Line and Eligible for Autologous Transplantation

acronym: BV-ICE

summary:
This study is designed as a phase Ib/II trial. The first part (phase Ib) is a dose escalation design to explore the safety and assess the recommended phase 2 dose of Brentuximab Vedotin in Hodgkin lymphoma patients treated with ICE regimen.

The second part, depending on the selected dose after the completion of phase Ib part of the study, will further explore safety in addition to efficacy of the recommended dose of Brentuximab Vedotin in a selected population of patients treated with ICE with Hodgkin lymphoma.

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: CHU de Poitiers - Hôpital de La Milétrie

location_facility: Institut d'Hématologie de Basse Normandie - CHU Côte de Nacre


title: Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis- In-TARGET

acronym: In-TARGET

summary:
PHASE: IV

TYPE OF STUDY: With direct benefit

DESCRIPTIVE: multicenter, open-label, uncontrolled trial

INCLUSION CRITERIA: Adults with moderate to severe ulcerative colitis who failed corticosteroids and immunosupressive therapy, or are intolerant to immunosuppressors. All included patients will be naïve to anti-TNF therapy. Active disease at golimumab treatment initiation defined as a MAYO score ≥6 and with an endoscopic sub score ≥2.

OBJECTIVE: To determine the proportion of patients with Continuous Clinical Response (CCR) and endoscopic remission after one year of golumimab at week 54.

STUDY DESIGN:

Induction Phase :

Week 0: golimumab 200mg- Week 2: golimumab 100 mg- Week 6: golimumab 50 mg

Maintenance Phase I : Week 10-Week 54 Week 10-Week 54 • Patients with primary clinical response*: Standard regimen with golimumab 50 mg Q4W (or 100 mg Q4W if > 80 kg)

Patients without primary clinical response at week 10 or with flare between week 10-week 54*: Optimization to 100 mg Q4W (or combination therapy with azathioprine if > 80 kg or switch from azathioprine to methotrexate if already on azathioprine at golimumab initiation or patient with known intolerance to thiopurines)

Early escape at Week 18: Primary non-responders who are still not responding at week 18 to dose optimization at Weeks 10 and 14 will be considered treatment failures and will be followed up (call or visit) at week 54 for safety.

Clinical response is defined as a decrease from baseline in the Mayo score ≥30% and ≥3 points, accompanied by either a rectal bleeding sub score of 0 or 1 or a decrease from baseline in the rectal bleeding sub score ≥1

Intermittent Phase II : Week 54-Week 108

• Patients with CCR and MH at week 54 and on golimumab 50 mg every 4 weeks: Stop golimumab and continuation of thiopurines or methotrexate if on combination therapy

• Patients with CCR and MH at week 54 and on golimumab 100 mg every 4 weeks: De-escalation to 50 mg every 4 weeks and continuation of thiopurines or methotrexate if on combination therapy

• Restart/Escalate golimumab on flare (defined in section 4 of the protocol) to the phase I dose; 50 mg q4wk or 100mg q4wk (similar to the phase I regimen)

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility: CHU de Colmar- Hopital Trousseau Medecine A


title: Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients

acronym: S-ICD Brugada

summary:
Brugada syndrome is an inherited arrhythmia syndrome with an increased risk of syncope and sudden death resulting from episodes of polymorphic ventricular tachychardia and fibrillation. Currently, there is no medical therapy for the Brugada syndrome and the only treatment available is the implantation of an ICD. There is no discussion on the interest of the ICD implantation in secondary prevention and in patients who experienced syncope but the best therapeutic is more difficult to draw in asymptomatic patients. Recently we demonstrated that in asymptomatic patients with a spontaneous type 1 aspect of Brugada syndrome, (i) there was a significant risk of ventricular arrhythmia, (ii) the problem of inappropriate shocks can be solve with a good ICD programming and (iii) the problem of lead failure remains the main problem in this young population very active and represent the main limitation to larger indication of ICD implantation in this population with a very long life expectancy as these patients had a normal life expectancy except the risk of ventricular arrhythmia.

In this context the S-ICD System (Boston Scientific Inc.) which is an implantable defibrillator technology that treats ventricular tachyarrhythmias using a subcutaneous pulse generator and electrode system rather than a transvenous lead system, represents a very attractive opportunity as it gives the possibility to protect the patients of the risk of ventricular arrhythmia with no risk of lead failure. However, as this is a new technology and as Brugada syndrome patients are a very specific population (very active patients, specific and changing over time ECG aspect that is at risk of T wave over sensing and high risk of SVT), it seems important to evaluate the effectiveness and the safety of S-ICD in this specific context.

lead_sponsor: Nantes University Hospital

location_country: Italy France Spain Denmark Germany

location_facility: Paris University Hospital - La pitié-Salpétrière


title: Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury

acronym: EPURE

summary:
Limited prospective data is available to compare morbidity and mortality between renal replacement modalities in pediatric acute renal failure.

In the absence of clear standard of care, the choice of the extra renal replacement therapy modality is subject to clinical judgement, practical aspects, and costs.

This study will supply important data about usual modalities of pediatric acute extra renal replacement therapy and their impact on patient outcome and renal recovery. An obvious next step will be to conduct a randomized controlled trial comparing the different strategies.

status: Terminated

location_country: Canada France Réunion

location_facility: Pediatric intensive care - Centre mère enfants

location_facility: Réanimation et Surveillance - Robert Debre Hospital

location_facility: Pediatry - Cote De Nacre University Hospital

location_facility: Pediatry - Hopital de la Mère et de l'Enfant

location_facility: Anesthesy-Pediatric reanimation - Nord University Hospital

location_facility: Nephrology - Pediatric emergency - Clocheville University Hospital

location_facility: Pediatric Nephrology and dianetology - Arnaud de Villeneuve Hospital

location_facility: Pediatric reanimation - Brabois Hospital

location_facility: Pediatric nephrology - Hôpital Couple-enfants

location_facility: Pediatric reanimation - Hôpital mère-enfant

intervention_type: Procedure


title: Phase 2/3 Study Evaluating Efficacy and Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA)Versus Reference L-asparaginase Treatment in Combination With Standard Polychemotherapy in Patient With First Recurrence of Philadelphia Negative Acute Lymphoblastic Leukemia

acronym: GRASPIVOTALL

summary:
Asparaginase is a cornerstone in the treatment of ALL, but its utility is limited by toxicities including hypersensitivity. Clinical allergy is associated with inactivation of asparaginase by antibodies (A-Abs), which can also neutralize asparaginase without any clinical signs of hypersensitivity (silent inactivation). GRASPA improves pharmacokinetics, tolerability and maintain circulating asparaginase activity due to the protective barrier of the erythrocyte membrane.

This study is run to confirm the benefit/risk profile of GRASPA at 150 IU/kg in combination with the COOPRALL regimen in adults and children patients with relapsed ALL, with or without known hypersensitivity to L-asparaginase.

ipd_sharing: Undecided

lead_sponsor: ERYtech Pharma

location_facility: Institut Hematologie Oncologie Pediatrique


title: A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance

summary:
The aims of this study are:

to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and
to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B).

ReferenceCitation: Azzouzi AR, Vincendeau S, Barret E, Cicco A, Kleinclauss F, van der Poel HG, Stief CG, Rassweiler J, Salomon G, Solsona E, Alcaraz A, Tammela TT, Rosario DJ, Gomez-Veiga F, Ahlgren G, Benzaghou F, Gaillac B, Amzal B, Debruyne FM, Fromont G, Gratzke C, Emberton M; PCM301 Study Group. Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301): an open-label, phase 3, randomised controlled trial. Lancet Oncol. 2017 Feb;18(2):181-191. doi: 10.1016/S1470-2045(16)30661-1. Epub 2016 Dec 20.

family: Azzouzi

full_name: Abdel-Rahmène Azzouzi

given: Abdel-Rahmène

family: Vincendeau

full_name: Sébastien Vincendeau

given: Sébastien

family: Barret

full_name: Eric Barret

given: Eric

family: Cicco

full_name: Antony Cicco

given: Antony

family: Kleinclauss

full_name: François Kleinclauss

given: François

family: van der Poel

full_name: Henk G van der Poel

given: Henk G

family: Stief

full_name: Christian G Stief

given: Christian G

family: Rassweiler

full_name: Jens Rassweiler

given: Jens

family: Salomon

full_name: Georg Salomon

given: Georg

family: Solsona

full_name: Eduardo Solsona

given: Eduardo

family: Alcaraz

full_name: Antonio Alcaraz

given: Antonio

family: Tammela

full_name: Teuvo T Tammela

given: Teuvo T

family: Rosario

full_name: Derek J Rosario

given: Derek J

family: Gomez-Veiga

full_name: Francisco Gomez-Veiga

given: Francisco

family: Ahlgren

full_name: Göran Ahlgren

given: Göran

family: Benzaghou

full_name: Fawzi Benzaghou

given: Fawzi

family: Gaillac

full_name: Bertrand Gaillac

given: Bertrand

family: Amzal

full_name: Billy Amzal

given: Billy

family: Debruyne

full_name: Frans M J Debruyne

given: Frans M J

family: Fromont

full_name: Gaëlle Fromont

given: Gaëlle

family: Gratzke

full_name: Christian Gratzke

given: Christian

family: Emberton

full_name: Mark Emberton

given: Mark

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

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

repository_institution: University College London - UCL Discovery

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

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

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

location_country:
Italy
Sweden
Switzerland
Netherlands
Finland
France
Belgium
Spain
Germany
United Kingdom

location_facility: Martini-Klinik am UKE Hamburg-Eppendorf Prostate Cancer Center

location_facility: Hospital 12 de Octubre - Departmento de Urologia

location_facility: Unità Operativa Urologia Lucca - c/o Azienda USL 2 - Ospedale Campo di Marte

location_facility: Department of Urology-Tampere University Hospital-

location_facility: Vinzenz Krankenhaus - Department of Urology

location_facility: Complejo Hospitalario Regional Virgen Del Rocio-Department Urology

location_facility: Osp. S. Giov. Battista Molinette-Dipartimento di Discipline Medico-Chirurgiche Urologia

location_facility: Service d'Urologie - Centre Hospitalier Universitaire d'Angers

location_facility: Centre Hospitalier Universitaire Lyon Sud

location_facility: Clinique d'Urologie et de Transplantation Rénale CHU Grenoble

location_facility: Dept. of Urology-University Hospitals Leuven

location_facility: Unità Operativa Urologica di Savona, Ospedale San Paolo di Savona

location_facility: Department of Urology-Hospital Clinic, University of Barcelona

location_facility: Hospital Universitari de Bellbitge-Servico de Urologia

location_facility: Centre Hospitalier Universitaire de Rangueil

location_facility: Unità di Chirurgia Urologica Mininvasiva

location_facility: ATURO-Gemeinschaftspraxis für Urologie und Andrologie

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität


lead_sponsor: Hoffmann-La Roche

location_country:
Sweden
Finland
France
Tunisia
Spain
Turkey
United Kingdom
Portugal

acronym: RiBECCA

title: A Randomized Study to Assess the Effect on Response Rate of MabThera (Rituximab) Added to a Standard Chemotherapy, Bendamustine or Chlorambucil, in Patients With Chronic Lymphocytic Leukemia

summary: This randomized, open-label, parallel group study will assess the effect on response rate and the safety of MabThera added to either bendamustine or chlorambucil in patients with chronic lymphocytic leukemia. Patients will be randomized to receive six 4-week cycles of either A) MabThera (375mg/m2 iv day 1 of cycle 1, 500mg/m2 iv cycles 2-6) plus bendamustine (90mg/m2 as first-line or 70mg/m2 as second-line therapy, iv on days 1 and 2, cycles 1-6), or B)MabThera plus chlorambucil (10mg/m2 po daily, days 1-7, cycles 1-6). Patients in group B can receive up to 6 further cycles of chlorambucil as monotherapy. Anticipated time on study treatment is 6-12 months, and target sample size is 600-700 individuals.


title: A Phase IIIb, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients With Prostate Cancer

summary: Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.

lead_sponsor: Ferring Pharmaceuticals

location_country: Italy Sweden France Belgium Spain Turkey Portugal

location_facility: Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau

location_facility: Centro Hospitalar Lisboa Norte, Hospital Santa Maria

location_facility: Istanbul University Faculty of Medicine - ÇAPA

location_facility: Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette

location_facility: CRLC Val d' Aurelle - Oncology Radiotherapy

location_facility: Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna

location_facility: Azienda Ospedaliero Universitaria Ospedali riuniti

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

location_facility: Hospital Universitario Principe de Asturias

location_facility: Cerrahpasa Faculty of Medicine - Kocamustafapasa

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Clinica Urologica - Azienda Ospedaliera di Perugia

location_facility: Marmara University Faculty of Medicine - Altunizade

location_facility: Ankara University Faculty of Medicine - Sıhhıye

location_facility: Hôpital Saint Louis - Radiotherapy Departement

location_facility: Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma

location_facility: Hospital Clinico Universitario S. Carlos

location_facility: Hospital Universitario Central de Asturias

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo


ReferenceCitation: Gonzalez-Martin A, Gladieff L, Tholander B, Stroyakovsky D, Gore M, Scambia G, Kovalenko N, Oaknin A, Ronco JP, Freudensprung U, Pignata S; OCTAVIA Investigators. Efficacy and safety results from OCTAVIA, a single-arm phase II study evaluating front-line bevacizumab, carboplatin and weekly paclitaxel for ovarian cancer. Eur J Cancer. 2013 Dec;49(18):3831-8. doi: 10.1016/j.ejca.2013.08.002. Epub 2013 Sep 2.

family: Gonzalez-Martin

full_name: Antonio Gonzalez-Martin

family: Gladieff

full_name: Laurence Gladieff

given: Laurence

family: Tholander

full_name: Bengt Tholander

given: Bengt

family: Stroyakovsky

full_name: Daniel Stroyakovsky

given: Daniel

family: Gore

full_name: Martin Gore

given: Martin

family: Scambia

full_name: Giovanni Scambia

given: Giovanni

family: Kovalenko

full_name: Nadezhda Kovalenko

given: Nadezhda

family: Oaknin

full_name: Ana Oaknin

given: Ana

family: Ronco

full_name: Julian Perez Ronco

given: Julian Perez

family: Freudensprung

full_name: Ulrich Freudensprung

given: Ulrich

family: Pignata

full_name: Sandro Pignata

given: Sandro

location_country:
Italy
Brazil
Sweden
Netherlands
France
Norway
Russian Federation
Spain
United Kingdom

acronym: OCTAVIA

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Medisch Spectrum Twente Enschede; Internal Medicine

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: The Norvegian Radium Hospital Montebello; Dept of Oncology

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

location_facility: Uni Hospital Linkoeping; Dept. of Oncology

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica

location_facility: Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde

location_facility: Hospital das Clinicas - FMUSP, Oncologia

location_facility: A.O. Universitaria Policlinico Di Modena; Oncologia

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: Institut de Cancerologie de La Loire; Radiotherapie

location_facility: Sint Elizabeth Ziekenhuis; Inwendige Geneeskunde

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

location_facility: Hopital Antoine Beclere; Service de Medecine Interne

location_facility: Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Örebro University Hospital; Department of Gynecologic Oncology

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente

location_facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B

location_facility: Academisch Medisch Centrum; Inwendige Geneeskunde

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Academ Ziekenhuis Groningen; Medical Oncology

location_facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde

location_facility: Centre Hospitalier Henri Duffaut; Hematologie

location_facility: St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary

location_facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie

location_facility: GH Paris Saint Joseph; Hopital De Jour Oncologie

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

title: A Single-arm Phase II Clinical Study Investigating the Addition of Bevacizumab to Carboplatin and Weekly Paclitaxel as First-line Treatment in Patients With Epithelial Ovarian Cancer

summary: This single arm study evaluated the efficacy and safety of first-line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants received 6-8 3-week cycles of treatment with bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve (AUC) of 6 on day 1 of each cycle. Following combination chemotherapy, bevacizumab could be continued to be given as a monotherapy.


title: Observational Cohort Study to Evaluate Safety and Efficacy of Pradaxa (Dabigatran Etexilate) in Patients With Moderate Renal Impairment (Creatinine Clearance 30-50 ml/Min) Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery

summary: An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Austria
Sweden
France
Spain
Germany
United Kingdom

location_facility: 1160.84.04407 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3313 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3314 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3323 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3320 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3322 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3326 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3402 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3324 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3311 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3409 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04927 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04948 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3310 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3306 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04405 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3319 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3305 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04403 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04946 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.03908 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3410 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.03902 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.03909 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3316 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3405 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4603 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04903 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04929 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3401 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04902 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3403 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4601 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3312 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3335 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4604 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04938 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04913 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04947 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3303 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04408 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04401 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.03904 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3404 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4301 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4922 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3332 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.4310 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3412 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3307 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3334 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.3302 Boehringer Ingelheim Investigational Site

location_facility: 1160.84.04914 Boehringer Ingelheim Investigational Site


title: Multicenter, Randomized Study Comparing the Efficacy and Safety of Two Doses of Thalidomide (100 mg/Day Versus 400 mg/Day) in the Treatment of Subjects With Refractory or Relapsed Multiple Myeloma.

summary: The objective of this study is to show that thalidomide at a dose of 100 mg/d (with remedial treatment with dexamethasone if a progression occurs) is equivalent in terms of efficacy with thalidomide at 400 mg/d (with remedial treatment with dexamethasone if a progression occurs) in the treatment of refractory or relapsed multiple myeloma after at least two courses of treatment. The use of thalidomide at 100 mg/d should reduce the side effects and improve the safety of the treatment.

ReferenceCitation: Yakoub-Agha I, Mary JY, Hulin C, Doyen C, Marit G, Benboubker L, Voillat L, Moreau P, Berthou C, Stoppa AM, Maloisel F, Rodon P, Dib M, Pegourie B, Casassus P, Slama B, Damaj G, Zerbib R, Harousseau JL, Mohty M, Facon T; Intergroupe Francophone du Myélome (IFM). Low-dose vs. high-dose thalidomide for advanced multiple myeloma: a prospective trial from the Intergroupe Francophone du Myélome. Eur J Haematol. 2012 Mar;88(3):249-59. doi: 10.1111/j.1600-0609.2011.01729.x. Epub 2012 Jan 4.

lead_sponsor: Celgene

location_facility: Centre Hospitalier General - Medecine Interne

location_facility: Centre Hospitalier - Service Hematologie

location_facility: Centre Hospitalier Général - Service d'Hématologie

location_facility: CHR Hôp N.D. de Bon Secours - Service de Médecine A

location_facility: Centre Hospitalier Laennec - Service de Médecine A

location_facility: C.H.U. de Saint Etienne - Hôpital Bellevue - Sce Rhumatologie

location_facility: CHRU Hôtel Dieu, Service des Maladies du Sang

location_facility: Centre Hospitalier D'Annecy - Service d'oncohématologie

location_facility: Centre Henri Becquerel - Service Hématologie

location_facility: CHU Hôpital Brabois - Médecine interne-Hématologie

location_facility: Centre Hospitalier Du Dr Duschene - Hematologie

location_facility: Centre Hospitalier - Service de Rhumatologie

location_facility: Hopital Avicenne - Medecine Interne/Hematologie

location_facility: CENTRE HOSPITALIER DEPARTEMENTAL - Sce Médecine A

location_facility: INSTITUT PAOLI CALMETTE - Unité transplantation

location_facility: Centre Hospitalier La Rochelle - Unité d'Oncologie Médicale

location_facility: Centre Hospitalier de Blois - Unité d'Onco-Hématologie

location_facility: HOPITAL JEAN MINJOZ - Médecine interne/Hématologie

location_facility: HOPITAL HAUTEPIERRE - Service Rhumatologie

location_facility: Centre Hospitalier Chubert - Médecine Interne

location_facility: Centre Hospitalier - Service de Médecine 7

location_facility: Centre Hospitalier H. Duffaut - Hematologie


title: Prospective Study of Predictive Factors of Sustained Remission of Crohn's Disease After Stopping Infliximab

acronym: STORI

summary:
1 Project summary 1.1 Rational. Accent 1 study has demonstrated the superiority of Infliximab over placebo in a systematic treatment strategy of Crohn 's disease every 8 weeks during one year. However the optimal strategy beyond one year of treatment is not established. Particularly, the need for carrying on systematic treatment with infliximab in all the patients has not been demonstrated.

1.2 Primary objective. Determine factors associated with a low risk of clinical relapse after stopping infliximab in CD patients in remission (CDAI<150) and regularly treated with infliximab for at least one year.

1.3 Main objective and main judgement criteria. Determine predictive factors for relapse within one year after stopping infliximab. Main judgement criteria is the clinical relapse after stopping infliximab. Clinical relapse is defined either by a CDAI>250 or by a CDAI between 150 and 250 if this CDAI is confirmed over two consecutive weeks with an increase of at least 70 points over baseline for the two consecutive measures.

1.4 Secondary objectives and judgement criteria. Determine the time to-relapse Determine predictive factors for short-term relapse (<2 months)after stopping infliximab.

Determine response to infliximab retreatment in these patients. Determine tolerance to infliximab retreatment in these patients. Determine predictive factors for an absence of response to retreatment. Determine predictive factors for infliximab retreatment intolerance. Determine sustained response in the retreated patients.

1.5 Type of study Open-label prospective study of stopping regular treatment. Inclusion period: minimum one year, possibly prolonged to reach 100 patients. Patients will be followed up every two months for at least 18 months after stopping infliximab.

1.6 Justification of the number of patients Number of patients to include is at least 100. This recruitment should be reached within one year. This number should allow to disclose predictive factors associated with a relative risk of at least 2 if this factor is equilibrated (50% at risk patients) or 3 is this factor is disequilibrated (90% at risk patients).

ReferenceCitation: Vermeire S, Louis E, Carbonez A, Van Assche G, Noman M, Belaiche J, De Vos M, Van Gossum A, Pescatore P, Fiasse R, Pelckmans P, Reynaert H, D'Haens G, Rutgeerts P; Belgian Group of Infliximab Expanded Access Program in Crohn's Disease. Demographic and clinical parameters influencing the short-term outcome of anti-tumor necrosis factor (infliximab) treatment in Crohn's disease. Am J Gastroenterol. 2002 Sep;97(9):2357-63.

ReferenceCitation: Parsi MA, Achkar JP, Richardson S, Katz J, Hammel JP, Lashner BA, Brzezinski A. Predictors of response to infliximab in patients with Crohn's disease. Gastroenterology. 2002 Sep;123(3):707-13.

ReferenceCitation: Farrell RJ, Alsahli M, Jeen YT, Falchuk KR, Peppercorn MA, Michetti P. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn's disease: a randomized controlled trial. Gastroenterology. 2003 Apr;124(4):917-24.

ReferenceCitation: Baert F, Noman M, Vermeire S, Van Assche G, D' Haens G, Carbonez A, Rutgeerts P. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med. 2003 Feb 13;348(7):601-8.

ReferenceCitation: Tampo Y, Yonaha M. Antioxidant mechanism of Mn(II) in phospholipid peroxidation. Free Radic Biol Med. 1992;13(2):115-20.

ReferenceCitation: Parsi MA, Lashner BA. Safety of infliximab: primum non nocere. The safety profile of infliximab in patients with Crohn's disease: the Mayo Clinic experience in 500 patients. Inflamm Bowel Dis. 2004 Jul;10(4):486-7.

ReferenceCitation: Keane J, Gershon S, Wise RP, Mirabile-Levens E, Kasznica J, Schwieterman WD, Siegel JN, Braun MM. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med. 2001 Oct 11;345(15):1098-104.

ReferenceCitation: Louis E, Mary JY, Vernier-Massouille G, Grimaud JC, Bouhnik Y, Laharie D, Dupas JL, Pillant H, Picon L, Veyrac M, Flamant M, Savoye G, Jian R, Devos M, Porcher R, Paintaud G, Piver E, Colombel JF, Lemann M; Groupe D'etudes Thérapeutiques Des Affections Inflammatoires Digestives. Maintenance of remission among patients with Crohn's disease on antimetabolite therapy after infliximab therapy is stopped. Gastroenterology. 2012 Jan;142(1):63-70.e5; quiz e31. doi: 10.1053/j.gastro.2011.09.034. Epub 2011 Sep 22.

family: Louis

full_name: Edouard Louis

given: Edouard

family: Mary

full_name: Jean–Yves Mary

given: Jean–Yves

family: Vernier–Massouille

full_name: Gwenola Vernier–Massouille

given: Gwenola

family: Grimaud

full_name: Jean–Charles Grimaud

given: Jean–Charles

family: Bouhnik

full_name: Yoram Bouhnik

given: Yoram

family: Laharie

full_name: David Laharie

given: David

family: Dupas

full_name: Jean–Louis Dupas

given: Jean–Louis

family: Pillant

full_name: Hélène Pillant

given: Hélène

family: Picon

full_name: Laurence Picon

family: Veyrac

full_name: Michel Veyrac

given: Michel

family: Flamant

full_name: Mathurin Flamant

given: Mathurin

family: Savoye

full_name: Guillaume Savoye

given: Guillaume

family: Jian

full_name: Raymond Jian

given: Raymond

family: DeVos

full_name: Martine DeVos

given: Martine

family: Porcher

full_name: Raphaël Porcher

given: Raphaël

family: Paintaud

full_name: Gilles Paintaud

given: Gilles

family: Piver

full_name: Eric Piver

given: Eric

family: Colombel

full_name: Jean–Frédéric Colombel

given: Jean–Frédéric

family: Lemann

full_name: Marc Lemann

given: Marc

journal_name: Gastroenterology

title: Maintenance of Remission Among Patients With Crohn's Disease on Antimetabolite Therapy After Infliximab Therapy Is Stopped

location_facility:
Hopital Haut Leveque
Hopital Henri Mondor
Chu Strasbourg
Hopital Beaujon
Ch Le Raincy Montfermeil
CHRU Lille
Hopital Saint Louis
Hopital Saint Andre
Chu Nantes
CHU LYON
Hopital Louis Mourier
Chu Besancon
Hopital Lariboisiere
Chu Rouen
Chu Tours
Gent University Hospital
Chu Montpellier
Chu Marseille - Hopital Nord
Hopital Georges Pompidou
CHU LIEGE - Sart Tilman
CHU CAEN
Chu Amiens
Chu Toulouse


title: A Controlled, Randomized, Double-blind, Multicenter Study, Comparing Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis

acronym: METEOR

summary:
PHASE: II
TYPE OF STUDY : With direct benefit
DESCRIPTIVE: Multicenter, randomized, double-blind study
INCLUSION CRITERIA: Steroid-dependent ulcerative colitis
OBJECTIVES: To show superiority of methotrexate vs placebo in inducing steroid-free remission in steroid-dependent ulcerative colitis
STUDY TREATMENTS: Methotrexate 1 intramuscular injection (25 mg) per week Placebo 1 intramuscular injection per week
NUMBERS OF PATIENTS: 55 patients in each group, i.e. a total of 110 patients
INCLUSION PERIOD: 24 months
STUDY DURATION: 36 months
EVALUATION CRITERIA: Remission without steroids, immunosuppressives and without colectomy at 16 weeks of treatment.

ReferenceCitation: Carbonnel F, Colombel JF, Filippi J, Katsanos KH, Peyrin-Biroulet L, Allez M, Nachury M, Novacek G, Danese S, Abitbol V, Bossa F, Moreau J, Bommelaer G, Bourreille A, Fumery M, Roblin X, Reinisch W, Bouhnik Y, Brixi H, Seksik P, Malamut G, Färkkilä M, Coulibaly B, Dewit O, Louis E, Deplanque D, Michetti P, Sarter H, Laharie D; European Crohn's and Colitis Organisation; Groupe d'Étude Thérapeutique des Affections Inflammatoires Digestives. Methotrexate Is Not Superior to Placebo for Inducing Steroid-Free Remission, but Induces Steroid-Free Clinical Remission in a Larger Proportion of Patients With Ulcerative Colitis. Gastroenterology. 2016 Feb;150(2):380-8.e4. doi: 10.1053/j.gastro.2015.10.050. Epub 2015 Nov 26.

family: Carbonnel

full_name: Franck Carbonnel

given: Franck

full_name: Jean Frédéric Colombel

given: Jean Frédéric

family: Filippi

full_name: Jérome Filippi

given: Jérome

family: Katsanos

full_name: Konstantinos H. Katsanos

given: Konstantinos H.

family: Peyrin-Biroulet

full_name: Laurent Peyrin-Biroulet

given: Laurent

family: Allez

full_name: Mathieu Allez

given: Mathieu

family: Nachury

full_name: Maria Nachury

given: Maria

family: Novacek

full_name: Gottfried Novacek

given: Gottfried

family: Danese

full_name: Silvio Danese

given: Silvio

family: Abitbol

full_name: Vered Abitbol

given: Vered

family: Bossa

full_name: Fabrizio Bossa

given: Fabrizio

family: Moreau

full_name: Jacques Moreau

given: Jacques

family: Bommelaer

full_name: Gilles Bommelaer

family: Bourreille

full_name: Arnaud Bourreille

given: Arnaud

family: Fumery

full_name: Mathurin Fumery

family: Roblin

full_name: Xavier Roblin

given: Xavier

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Brixi

full_name: Hedia Brixi

given: Hedia

family: Seksik

full_name: Philippe Seksik

given: Philippe

family: Malamut

full_name: Georgia Malamut

given: Georgia

family: Färkkilä

full_name: Martti Färkkilä

given: Martti

family: Coulibaly

full_name: Baya Coulibaly

given: Baya

repository_institution: University of Liège - Open Repository and Bibliography

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_country: Italy Austria Netherlands France Israel Belgium

location_facility: CHU Clermont-Ferrand - Hôpital Hotel Dieu

location_facility: Centre Hospitalier Universitaire de Besançon