ReferenceCitation: Stilgenbauer S, Bosch F, Ilhan O, Kisro J, Mahé B, Mikuskova E, Osmanov D, Reda G, Robinson S, Tausch E, Turgut M, Wójtowicz M, Böttcher S, Perretti T, Trask P, Van Hoef M, Leblond V, Foà R. Safety and efficacy of obinutuzumab alone or with chemotherapy in previously untreated or relapsed/refractory chronic lymphocytic leukaemia patients: Final analysis of the Phase IIIb GREEN study. Br J Haematol. 2021 Apr;193(2):325-338. doi: 10.1111/bjh.17326. Epub 2021 Feb 19.

name: Department of Internal Medicine III Ulm University, Ulm and Innere Medizin IUniversitätsklinikum des Saarlandes Homburg Germany

family: Stilgenbauer

full_name: Stephan Stilgenbauer

given: Stephan

name: Department of Hematology University Hospital Vall d’Hebron Barcelona Spain

family: Bosch

full_name: Francesc Bosch

given: Francesc

name: Internal Medical Sciences Departments Ankara University School of Medicine Ankara Turkey

family: Ilhan

full_name: Osman Ilhan

given: Osman

name: Onkologische Schwerpunktpraxis Lübeck Lübeck Germany

family: Kisro

full_name: Jens Kisro

given: Jens

name: Clinical Hematology CHU Nantes Hôtel‐Dieu Nantes France

family: Mahé

full_name: Béatrice Mahé

given: Béatrice

name: Department of Hemato‐oncology II National Cancer Institute Bratislava Slovakia Blokhin

family: Mikuskova

full_name: Eva Mikuskova

given: Eva

name: Cancer Research Center Russian Academy of Medical Sciences Moscow Russian Federation

family: Osmanov

full_name: Dzhelil Osmanov

given: Dzhelil

name: UOC Ematologia – Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico Milano Italy

family: Reda

full_name: Gianluigi Reda

given: Gianluigi

name: QEII Health Sciences Centre Halifax NS Canada

family: Robinson

full_name: Sue Robinson

given: Sue

name: Department of Internal Medicine III Ulm University Ulm Germany

family: Tausch

full_name: Eugen Tausch

given: Eugen

name: Department of Internal Medical Sciences Ondokuz Mayis University Samsun Turkey

family: Turgut

full_name: Mehmet Turgut

given: Mehmet

name: Clinical Department of Hematology Hematological Oncology and Internal Diseases Szpital Wojewodski Opole Poland

family: Wójtowicz

full_name: Marcin Wójtowicz

given: Marcin

name: Department III of Internal Medicine Rostock University Medical CenterRostock (current affiliation) and University Hospital Schleswig‐Holstein Kiel Germany

family: Böttcher

full_name: Sebastian Böttcher

given: Sebastian

name: PDB Biostatistics –Medical Affairs F. Hoffmann‐La Roche Ltd Basel Switzerland

family: Perretti

full_name: Thomas Perretti

given: Thomas

name: Patient Centered Outcomes Research Genentech Inc South San Francisco CA USA

family: Trask

full_name: Peter Trask

given: Peter

name: Global Product Development – Medical Affairs F. Hoffmann‐La Roche Ltd Basel Switzerland

family: Van Hoef

full_name: Marlies Van Hoef

given: Marlies

name: Clinical Hematology Sorbonne UniversitéAP‐HP Hôpital Pitié Salpêtrière Paris France

family: Leblond

full_name: Véronique Leblond

given: Véronique

name: Division of Hematology Sapienza University Rome Italy

family: Foà

full_name: Robin Foà

given: Robin

journal_name: British Journal of Haematology

oa_colors: green hybrid

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_normalized: HAL

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

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Bosch F, Cantin G, Cortelezzi A, Knauf W, Tiab M, Turgut M, Zaritskey A, Merot JL, Tausch E, Trunzer K, Robson S, Gresko E, Böttcher S, Foà R, Stilgenbauer S, Leblond V. Obinutuzumab plus fludarabine and cyclophosphamide in previously untreated, fit patients with chronic lymphocytic leukemia: a subgroup analysis of the GREEN study. Leukemia. 2020 Feb;34(2):441-450. doi: 10.1038/s41375-019-0554-1. Epub 2019 Aug 27.

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

ReferenceCitation: Stilgenbauer S, Leblond V, Foà R, Böttcher S, Ilhan O, Knauf W, Mikuskova E, Renner C, Tausch E, Woszczyk D, Gresko E, Lundberg L, Moore T, Morris T, Robson S, Bosch F. Obinutuzumab plus bendamustine in previously untreated patients with CLL: a subgroup analysis of the GREEN study. Leukemia. 2018 Aug;32(8):1778-1786. doi: 10.1038/s41375-018-0146-5. Epub 2018 Apr 27.

location_country:
North Macedonia
Finland
Greece
Romania
Belgium
Russian Federation
France
Poland
Lithuania
Slovakia
Thailand
Argentina
Canada
Slovenia
Korea, Republic of
Turkey
Sweden
Switzerland
Ireland
Portugal
Germany
Italy
Brazil
Bosnia and Herzegovina
Serbia
Mexico
Israel
Egypt
Spain
Estonia
Latvia

location_facility: Onkologische Schwerpunktpraxis Dres. Rudolf Schlag und Björn Schöttker

location_facility: Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie

location_facility: Arcispedale S. Anna; Sezione Di Ematologia

location_facility: Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie

location_facility: Hopital Saint Antoine; Hematologie Clinique

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

location_facility: Ch Du Mans; Medecine Hematologie Oncologie

location_facility: Centro Medico Nacional Sxxi - Imss; Haematology

location_facility: Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie

location_facility: Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol

location_facility: Hospital Universitario Reina Sofia; Servicio de Hematologia

location_facility: Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter

location_facility: Istituto Oncologico della Svizzera Italiana (IOSI)

location_facility: Ondokuzmayis University Medical Faculty Heamatology Department

location_facility: Hopital Hotel Dieu Et Hme;Hopital De Jour

location_facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP

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

location_facility: Turku Uni Central Hospital; Dept of Internal Medicine

location_facility: Universitetssjukhuset i Linköping, Hematologkliniken

location_facility: Almazov Federal Heart, Blood and Endocrinilogy Centre; Hematology department

location_facility: Hospital Quiron de Madrid; Servicio de Hematologia

location_facility: Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej

location_facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

location_facility: Ramathibodi Hospital; Division of Hematology, Department of Medicine

location_facility: Gemeinschaftspraxis; Prof. Dr. Michael Kiehl und Dr.med. Wolfgang Stein

location_facility: Regional health authority A vitalite health network

location_facility: Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin

location_facility: Dres. Hans-Dieter Schick Dorothea Schick Burkhard Schmidt u.w.

location_facility: Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: Hospital Infanta Leonor; Servicio de Hematologia

location_facility: Tartu Uni Hospital; Hematology - Oncology Clinic

location_facility: Hospital Universitario Dr. Jose E. Gonzalez; Haematology

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: AUSL di Piacenza - Ospedale "Guglielmo da Saliceto";U.O. Ematologia

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia

location_facility: Cairo University Hospital Al Kasr El Ainy

location_facility: Azienda USL 6 Livorno - P.O. Livorno; U.O. Ematologia Clinica

location_facility: Bnei-Zion Medical Center; Hematology Dept

location_facility: Soroka Medical Center; Hematology Deptartment

location_facility: Karadeniz Technical Uni School of Medicine; Hematology

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: Hospital Estadual do Servidor Publico; Hematologia

location_facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddział Chorób Wewnetrznych/Hematologiczny

location_facility: Centro de Estudios Clinicos de Queretaro (CECLIQ)

location_facility: Ankara Numune Egitim Ve Arastirma Hastanesi; Hematoloji Klinigi

location_facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

location_facility: Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center

location_facility: Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia

location_facility: University Hospital of Ioannina; Hematology

location_facility: Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll

location_facility: Centre de sante et de services sociaux Rimouski Neigette

location_facility: Spitalul Clinic Coltea; Clinica de Hematologie

location_facility: Hopital Bretonneau; Hematologie Therapie Cellulaire

location_facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: Kantonsspital Graubünden;Onkologie und Hämatologie

location_facility: Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials

location_facility: Hospital De Txagorritxu; Servicio de Hematologia

location_facility: Gemeinschaftspraxis Dr. med. Holger Klaproth / Dr. med. Anca Astrid Cura

location_facility: Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Ospedale Cardarelli; Divisione Di Ematologia

location_facility: Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

location_facility: Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad

location_facility: Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia

location_facility: Complejo Hospitalario San Millan - San Pedro; Servicio Hematologia

location_facility: IPO do Porto; Servico de Onco-Hematologia

location_facility: Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine

location_facility: Skane University Hospital Malmo/Lund, Dept.of Hematology and Coagulation Disorders

location_facility: North Estonia Regional Hospital; Hematology

location_facility: Hopital Pitie Salpetriere; Hematologie Clinique

location_facility: Uni Degli Studi Di Genova; 1A Divisione Di Ematologia

location_facility: Hospital das Clinicas - FMUSP; Hematologia

location_facility: CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: Saskatoon Cancer Centre; Uni of Saskatoon Campus

location_facility: Vladimirskiy Regional Scientific Research Inst. ; Hematology

location_facility: Centre Hospitalier René Dubos; Hematologie

location_facility: Ichilov Sourasky Medical Center; Heamatology

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Az. Osp. Pugliese; Divisione de Ematologia

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: University Clinic of Hematology Skopje, Hospital Care Department

location_facility: Ospedale Vito Fazzi; Div. Oncoematologia

location_facility: RECUH, Oncology Centre of Latvia; Clinic of Chemotherapy and Heamatology

location_facility: University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept

location_facility: Hospital Sirio Libanes; Centro de Oncologia

location_facility: Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine

location_facility: Hopital Cote De Nacre; Hematologie Biologique

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Hematología

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia

location_facility: University Clinical Center Sarajevo, Clinic for Hematology

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Fakultna Nemocnica Roosevelta; Dept. of Haematology

location_facility: Ospedale Molinette - Universita' Di Torino; Cliniche Universitarie Ematologia I

location_facility: Hospital General De Culiacan; Servicio De Hematologia

location_facility: Hospital San Pedro De Alcantara; Servicio de Hematologia

location_facility: Laiko General Hospital; Hematology Clinic

location_facility: Hospital Universitario la Fe; Servicio de Hematologia

location_facility: King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine

location_facility: Clinical Center Ljubljana; Haematology Dept

location_facility: Gaziantep University Medical School; Hematology

location_facility: Hopital Saint Eloi; Hematologie Oncologie Medicale

location_facility: Spitalul Clinic Judetean de Urgenta Brasov; Clinica de Hematologie

location_facility: Schwerpunktpraxis & Tagesklinik f. Hämatologie & Onkologie Regensdorf / Schwandorf / Wörth

location_facility: Chu Estaing; Hematologie Clinique Adultes

location_facility: General Hospital of Athens Evangelismos; Hematology

location_facility: Hadassah Ein Karem Hospital; Haematology

location_facility: National Oncology Inst. ; Dept. of Haematology

location_facility: Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia

location_facility: Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin

location_facility: Waterford Regional Hospital; Department Of Medical Oncology

location_facility: Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula

location_facility: Hopital Robert Debre; Hematologie Clinique

location_facility: Azienda ospedaliera oo rr di foggi; Hematology

location_facility: Onkologisches Zentrum am Bethanien-Kankenhaus

location_facility: Georgios Papanikolaou Hospital; Hematology Department

location_facility: Siriraj Hospital; Division of Hematology, Department of Medicine

title: A Multicenter, Open-Label, Single-Arm, Phase IIIb, International Study Evaluating the Safety of Obinutuzumab Alone or in Combination With Chemotherapy in Patients With Previously Untreated or Relapsed/Refractory Chronic Lymphocytic Leukemia

summary: This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). This is a Post-Authorization Safety Study. Participants will receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with chemotherapy at the investigator's discretion. Each participant will be followed until 30 months after the last participant has been enrolled. Total length of the study is anticipated to be approximately 5 years.


type: Other Identifier

title: A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients

acronym: TERI-PRO

summary:
Primary Objective:

To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Participant Reported Outcomes (PROs).

Secondary Objectives:

To describe disease progression using PROs. To describe clinical outcomes (ie, treated relapses) in teriflunomide treated participant.

To describe the change in cognition in teriflunomide treated participants. To describe safety of teriflunomide in participant treated (based on adverse events reporting).

To describe adherence and persistence to teriflunomide treatment. To describe quality of life, activity and leisure over the period of teriflunomide treatment.

To compare Participant Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Coyle PK, Khatri B, Edwards KR, Meca-Lallana JE, Cavalier S, Rufi P, Benamor M, Poole EM, Robinson M, Gold R. Teriflunomide real-world evidence: Global differences in the phase 4 Teri-PRO study. Mult Scler Relat Disord. 2019 Jun;31:157-164. doi: 10.1016/j.msard.2019.03.022. Epub 2019 Mar 30.

family: Coyle

full_name: Patricia K. Coyle

given: Patricia K.

sequence: first

family: Khatri

full_name: Bhupendra Khatri

given: Bhupendra

sequence: additional

family: Edwards

full_name: Keith R. Edwards

given: Keith R.

family: Meca-Lallana

full_name: José E. Meca-Lallana

given: José E.

family: Cavalier

full_name: Steve Cavalier

given: Steve

family: Rufi

full_name: Pascal Rufi

given: Pascal

family: Benamor

full_name: Myriam Benamor

given: Myriam

family: Poole

full_name: Elizabeth M. Poole

given: Elizabeth M.

full_name: Miqun Robinson

given: Miqun

family: Gold

full_name: Ralf Gold

given: Ralf

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Multiple Sclerosis and Related Disorders

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Coyle PK, Khatri B, Edwards KR, Meca-Lallana JE, Cavalier S, Rufi P, Benamor M, Brette S, Robinson M, Gold R; Teri-PRO Trial Group. Patient-reported outcomes in relapsing forms of MS: Real-world, global treatment experience with teriflunomide from the Teri-PRO study. Mult Scler Relat Disord. 2017 Oct;17:107-115. doi: 10.1016/j.msard.2017.07.006. Epub 2017 Jul 6.

family: Brette

full_name: Sandrine Brette

given: Sandrine

location_country:
Italy
Austria
United States
Chile
Sweden
Germany
Finland
France
Greece
Norway
Belgium
Spain
Canada
United Kingdom

location_facility:
Investigational Site Number 840075
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type: EudraCT Number

title: Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)

acronym: AEGEAN

summary: The study purpose is to assess the impact of an educational program on patient adherence in patients taking Apixaban for SPAF at 24 weeks

study_start_date_type: Actual

design_allocation: Randomized

primary_purpose: Other

ReferenceCitation: Montalescot G, Brotons C, Cosyns B, Crijns HJ, D'Angelo A, Drouet L, Eberli F, Lane DA, Besse B, Chan A, Vicaut E, Darius H; AEGEAN Study Investigators. Educational Impact on Apixaban Adherence in Atrial Fibrillation (the AEGEAN STUDY): A Randomized Clinical Trial. Am J Cardiovasc Drugs. 2020 Feb;20(1):61-71. doi: 10.1007/s40256-019-00356-2.

family: Montalescot

full_name: Gilles Montalescot

given: Gilles

family: Brotons

full_name: Carlos Brotons

given: Carlos

family: Cosyns

full_name: Bernard Cosyns

given: Bernard

family: Crijns

full_name: Harry J. Crijns

given: Harry J.

family: D’Angelo

full_name: Armando D’Angelo

given: Armando

family: Drouet

full_name: Ludovic Drouet

given: Ludovic

family: Eberli

full_name: Franz Eberli

given: Franz

family: Lane

full_name: Deirdre A. Lane

given: Deirdre A.

family: Besse

full_name: Bruno Besse

given: Bruno

family: Chan

full_name: Anthony Chan

given: Anthony

family: Vicaut

full_name: Eric Vicaut

given: Eric

family: Darius

full_name: Harald Darius

given: Harald

journal_name: American Journal of Cardiovascular Drugs

oa_host_type: publisher;repository

license: cc-by-nc

license_normalized: cc-by-nc

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Switzerland
France
Belgium
Spain
Germany
United Kingdom


title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients

summary: The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.

ReferenceCitation: Matsue Y, Sama IE, Postmus D, Metra M, Greenberg BH, Cotter G, Davison BA, Felker GM, Filippatos G, Pang P, Ponikowski P, Severin T, Gimpelewicz C, Voors AA, Teerlink JR. Association of Early Blood Pressure Decrease and Renal Function With Prognosis in Acute Heart Failure. JACC Heart Fail. 2021 Sep 30. pii: S2213-1779(21)00331-0. doi: 10.1016/j.jchf.2021.07.001. [Epub ahead of print]

family: Matsue

full_name: Yuya Matsue

given: Yuya

family: Sama

full_name: Iziah E. Sama

given: Iziah E.

family: Postmus

full_name: Douwe Postmus

given: Douwe

family: Metra

full_name: Marco Metra

given: Marco

family: Greenberg

full_name: Barry H. Greenberg

given: Barry H.

family: Cotter

full_name: Gad Cotter

given: Gad

family: Davison

full_name: Beth A. Davison

given: Beth A.

family: Felker

full_name: G. Michael Felker

given: G. Michael

family: Filippatos

full_name: Gerasimos Filippatos

given: Gerasimos

family: Pang

full_name: Peter Pang

given: Peter

family: Ponikowski

full_name: Piotr Ponikowski

given: Piotr

family: Severin

full_name: Thomas Severin

given: Thomas

family: Gimpelewicz

full_name: Claudio Gimpelewicz

given: Claudio

family: Voors

full_name: Adriaan A. Voors

given: Adriaan A.

family: Teerlink

full_name: John R. Teerlink

given: John R.

journal_name: JACC: Heart Failure

ReferenceCitation: Grand J, Miger K, Sajadieh A, Køber L, Torp-Pedersen C, Ertl G, López-Sendón J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials. J Am Heart Assoc. 2021 Sep 21;10(18):e022288. doi: 10.1161/JAHA.121.022288. Epub 2021 Sep 13.

name: Department of Cardiology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark

family: Grand

full_name: Johannes Grand

given: Johannes

family: Miger

full_name: Kristina Miger

given: Kristina

family: Sajadieh

full_name: Ahmad Sajadieh

given: Ahmad

name: Department of Cardiology, Rigshospitalet University of Copenhagen Copenhagen Denmark

family: Køber

full_name: Lars Køber

given: Lars

name: Department of Cardiology Hillerød Hospital Hillerød Denmark

family: Torp‐Pedersen

full_name: Christian Torp‐Pedersen

given: Christian

name: Comprehensive Heart Failure Center University Hospital Würzburg Germany

name: Department of Cardiology Associazione Nazionale Medicin Cardiologi Ospedalieri Research Center Florence Italy

family: Ertl

name: Department of Cardiology Hospital La PazIdiPazUniversidad Autonoma de Madrid Madrid Spain

name: Department of Cardiology Maria Cecilia HospitalGruppo Villa Maria S.p.A Care & Research Lugo Italy

name: Department of Cardiology University of CaliforniaSan FranciscoSan Francisco VA Medical Center Cardiology San Francisco CA

name: Department of Cardiovascular Medicine Kawaguchi Cardiovascular and Respiratory Hospital Saitama Japan

name: Cardiology Department of Medical and Surgical Specialties Cardiothoracic Department Radiological Sciences and Public Health Civil HospitalsUniversity of Brescia Brescia Italy

journal_name: Journal of the American Heart Association

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Loungani RS, Teerlink JR, Metra M, Allen LA, Butler J, Carson PE, Chen CW, Cotter G, Davison BA, Eapen ZJ, Filippatos GS, Gimpelewicz C, Greenberg B, Holbro T, Januzzi JL Jr, Lanfear DE, Pang PS, Piña IL, Ponikowski P, Miller AB, Voors AA, Felker GM. Cause of Death in Patients With Acute Heart Failure: Insights From RELAX-AHF-2. JACC Heart Fail. 2020 Dec;8(12):999-1008. doi: 10.1016/j.jchf.2020.09.010. Epub 2020 Nov 11.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

ReferenceCitation: Metra M, Teerlink JR, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH, Pang PS, Ponikowski P, Voors AA, Adams KF, Anker SD, Arias-Mendoza A, Avendaño P, Bacal F, Böhm M, Bortman G, Cleland JGF, Cohen-Solal A, Crespo-Leiro MG, Dorobantu M, Echeverría LE, Ferrari R, Goland S, Goncalvesová E, Goudev A, Køber L, Lema-Osores J, Levy PD, McDonald K, Manga P, Merkely B, Mueller C, Pieske B, Silva-Cardoso J, Špinar J, Squire I, Stępińska J, Van Mieghem W, von Lewinski D, Wikström G, Yilmaz MB, Hagner N, Holbro T, Hua TA, Sabarwal SV, Severin T, Szecsödy P, Gimpelewicz C; RELAX-AHF-2 Committees Investigators. Effects of Serelaxin in Patients with Acute Heart Failure. N Engl J Med. 2019 Aug 22;381(8):716-726. doi: 10.1056/NEJMoa1801291.

name: From Cardiology, Department of Medical and Surgical Specialties, Radiologic Sciences, and Public Health, University of Brescia, Brescia (M.M.), Centro Cardiologico Universitario di Ferrara, University of Ferrara, Ferrara (R.F.), and Maria Cecilia Hospital, GVM Care and Research, Cotignola (R.F.) — all in Italy; the Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California, San Francisco, San Francisco (J.R.T.), and the Division of Cardiology,...

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

repository_institution: Università degli Studi di Brescia - Institutional Research Information System

repository_institution: University of Ferrara - Institutional Research Information System University of Ferrara

repository_institution: University of Leicester - Leicester Research Archive

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Teerlink JR, Voors AA, Ponikowski P, Pang PS, Greenberg BH, Filippatos G, Felker GM, Davison BA, Cotter G, Gimpelewicz C, Boer-Martins L, Wernsing M, Hua TA, Severin T, Metra M. Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX-AHF-2 study. Eur J Heart Fail. 2017 Jun;19(6):800-809. doi: 10.1002/ejhf.830. Epub 2017 Apr 28.

name: Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco; San Francisco, CA, USA

name: Department of Cardiology, University Medical Center Groningen; Groningen, The Netherlands

name: Department of Heart Diseases; Medical University, Military Hospital; Wroclaw Poland

name: Indiana University School of Medicine; Department of Emergency Medicine and the Regenstrief Institute; Indianapolis IN USA

name: Division of Cardiology; University of California; San Diego CA USA

name: Athens University Hospital Attikon; Athens Greece

name: Division of Cardiology; Duke University School of Medicine; Durham NC USA

name: Novartis Pharmaceuticals Corporation; East Hanover NJ USA

name: Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health; University of Brescia; Brescia Italy

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

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

repository_institution: California Digital Library - eScholarship

location_country:
Peru
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
France
Poland
Slovakia
Norway
Argentina
Canada
Colombia
South Africa
Chile
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Ireland
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey


title: Efficacy of Alternating Immunochemotherapy Consisting of R-CHOP + R-HAD vs R-CHOP Alone, Followed by Maintenance Therapy Consisting of Additional Lenalidomide + Rituximab vs Rituximab Alone for Older Patients With Mantle Cell Lymphoma

summary:
This study aims to evaluate whether the addition of lenalidomide to rituximab-maintenance improves progression free survival (PFS) compared to standard rituximab maintenance after induction treatment consisting of R-CHOP + R-HAD vs R-CHOP alone in older patients (≥ 60 year old) with mantle cell lymphoma.

The treatments consist of two phases: induction treatment (3 R-CHOP21 + 3 cycles of R-HAD28 alternating) vs 8 cycles of R-CHOP21) followed by maintenance treatment (13 cycles of rituximab + 26 cycles of lenalidomide vs 13 cycles of rituximab).

status: Active, not recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Netherlands Spain Poland France Belgium Portugal Germany

location_facility: Gemeinschaftspraxis für Innere Medizin, Hämatologie und internistische Onkologie

location_facility: Uni-Klinikum-Schleswig-Holstein im Städt. Krankenhaus Kiel

location_facility: Charite´ Universitätsmedizin Berlin Campus Benjamin Franklin

location_facility: Internistische Praxis /Hämatologie und Onkologie

location_facility: DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH

location_facility: Université Catholique de Louvain Mont Godinne

location_facility: Hospital Universitario Central de Asturias

location_facility: Institut Catala d'Oncologia (ICO) - Hospital Germans Trias y Pujol

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Kliniken Maria Hilf GmbH (Krankenhaus St. Franziskus)

location_facility: Gemeinschaftspraxis für Hämatologie und internistische Onkologie

location_facility: Instituto Português de Oncologia de Lisboa de Francisco Gentil

location_facility: Charite´Universitätsmedizin Berlin Campus Virchow-Klinikum

location_facility: Institute of Hematology and Transfusiology

location_facility: Université Catholique de Louvain Saint Luc

location_facility: Hospital Universitario Fundación Alcorcón

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Multicentre, Dose Optimisation Study to Assess the Consistency of Efficacy of Eletriptan for the Treatment of Migraine (With and Without Aura)

summary: Evaluation of headache response at 2 hours for active treated attacks for increasing dose.

ReferenceCitation: Almas M, Tepper SJ, Landy S, Schweizer E, Ramos E. Consistency of eletriptan in treating migraine: Results of a randomized, within-patient multiple-dose study. Cephalalgia. 2014 Feb;34(2):126-35. doi: 10.1177/0333102413500726. Epub 2013 Aug 14.

family: Almas

full_name: Mary Almas

given: Mary

name: Headache Center, Cleveland Clinic, Cleveland, OH, USA

family: Tepper

full_name: Stewart J Tepper

given: Stewart J

name: Wesley Neurology Clinic, Memphis, TN, USA

family: Landy

full_name: Stephen Landy

given: Stephen

name: Paladin Consulting Group, Princeton, NJ, USA

family: Schweizer

full_name: Edward Schweizer

given: Edward

family: Ramos

full_name: Elodie Ramos

given: Elodie

journal_name: Cephalalgia

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country: Italy Sweden Netherlands Spain France Czechia Greece Norway Hungary Belgium Portugal Turkey Denmark Germany

location_facility: Fondazione Istituto Neurologico Casimiro Mondino Istituto Di Ricovero E Cura A Carattere Scientifico

location_facility: Clinica Neurologica, Universita Di Perugia

location_facility: Hospital General Universitari Vall D�Hebron

location_facility: 1St Medical Faculty of the Charles University

location_facility: Universita Degli Studi Di Modena-Policlinico Dipartimento Di Medicina Interna

location_facility: Fachklinik Fuer Neurologie Dietenbronn Gmbh

location_facility: Karadeniz Technical University Medical Faculty

location_facility: University of Debrecen, Medical and Health Science Centre, Medical School

location_facility: Hospital General Universitario J. M. Morales Meseguer

location_facility: Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis)

location_facility: Universita' Degli Studi Di Cagliari - Presidio Osp.S.Giovanni Di Dio

location_facility: Sint Lucas Andreas Ziekenhuis (Location: St.Lucas)

location_facility: Hospital Universitari de Lleida Arnau de Vilanova

status_simplified: Completed


ReferenceCitation: Facon T, Venner CP, Bahlis NJ, Offner F, White DJ, Karlin L, Benboubker L, Rigaudeau S, Rodon P, Voog E, Yoon SS, Suzuki K, Shibayama H, Zhang X, Twumasi-Ankrah P, Yung G, Rifkin RM, Moreau P, Lonial S, Kumar SK, Richardson PG, Rajkumar SV. Oral ixazomib, lenalidomide, and dexamethasone for transplant-ineligible patients with newly diagnosed multiple myeloma. Blood. 2021 Jul 1;137(26):3616-3628. doi: 10.1182/blood.2020008787.

name: Centre Hospitalier Universitaire (CHU) Lille, Service des Maladies du Sang, University of Lille, Lille, France;

family: Facon

full_name: Thierry Facon

given: Thierry

name: Division of Medical Oncology, Cross Cancer Institute, University of Alberta, Edmonton, AB, Canada;

family: Venner

full_name: Christopher P. Venner

given: Christopher P.

name: Division of Hematology and Oncology, Charbonneau Cancer Research Institute, University of Calgary, Calgary, AB, Canada;

family: Bahlis

full_name: Nizar J. Bahlis

given: Nizar J.

name: Department of Hematology, Ghent University Hospital, Ghent, Belgium;

family: Offner

full_name: Fritz Offner

given: Fritz

name: QEII Health Sciences Center and Dalhousie University, Halifax, NS, Canada;

family: White

full_name: Darrell J. White

given: Darrell J.

name: Hematology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre-Benite, France;

family: Karlin

full_name: Lionel Karlin

given: Lionel

name: Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU), Tours, France;

family: Benboubker

full_name: Lotfi Benboubker

given: Lotfi

name: Department of Clinical Hematology, Centre Hospitalier Versailles, Le Chesnay, France;

family: Rigaudeau

full_name: Sophie Rigaudeau

given: Sophie

name: Unité d'Hématologie et d'Oncologie, Centre Hospitalier Périgueux, Périgueux, France;

family: Rodon

full_name: Philippe Rodon

given: Philippe

family: Voog

full_name: Eric Voog

given: Eric

name: Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea;

family: Yoon

full_name: Sung-Soo Yoon

given: Sung-Soo

name: Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan;

family: Suzuki

full_name: Kenshi Suzuki

given: Kenshi

name: Department of Hematology and Oncology, Osaka University Graduate School of Medicine, Suita, Japan;

family: Shibayama

full_name: Hirohiko Shibayama

given: Hirohiko

name: Millennium Pharmaceuticals, Inc, Cambridge, MA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited;

family: Zhang

full_name: Xiaoquan Zhang

given: Xiaoquan

family: Twumasi-Ankrah

full_name: Philip Twumasi-Ankrah

given: Philip

family: Yung

full_name: Godwin Yung

given: Godwin

name: Rocky Mountain Cancer Centers/US Oncology Research, Denver, CO;

family: Rifkin

full_name: Robert M. Rifkin

given: Robert M.

name: Department of Hematology, University Hospital Hôtel Dieu, University of Nantes, Nantes, France;

family: Moreau

full_name: Philippe Moreau

name: Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA;

family: Lonial

full_name: Sagar Lonial

given: Sagar

name: Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN; and

family: Kumar

full_name: Shaji K. Kumar

given: Shaji K.

name: Medical Oncology, Dana-Farber Cancer Institute, Boston, MA

family: Richardson

full_name: Paul G. Richardson

given: Paul G.

family: Rajkumar

full_name: S. Vincent Rajkumar

given: S. Vincent

journal_name: Blood

evidence: open (via free article)

publisher: American Society of Hematology

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
United States
France
Belgium
Russian Federation
New Zealand
Canada
Korea, Republic of

title: A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma

summary: The purpose of this study is to provide continued access to ixazomib and/or lenalidomide to participants who are continuing to have clinical benefit and to continue collecting relevant safety data to monitor safety in participants with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell transplant.


title: The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer): A Multinational, Randomized, Open-label Phase 3 Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum

summary: The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Patients may be eligible to crossover from physician's choice chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed disease progression. Approximately 360 patients from North America, Europe and Australia will be enrolled in this study.

ReferenceCitation: Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. doi: 10.1200/JCO.20.01164. Epub 2020 Aug 21.

name: Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ

family: Monk

full_name: Bradley J. Monk

given: Bradley J.

name: Memorial Sloan Kettering Cancer Center, Weill Cornell Medical Center, New York, NY

family: Grisham

full_name: Rachel N. Grisham

given: Rachel N.

name: Royal Marsden National Health Service Foundation Trust and Institute of Cancer Research, London, United Kingdom

family: Banerjee

full_name: Susana Banerjee

given: Susana

name: Centre Hospitalier Régional et Universitaire de Besançon, CHRU de Besançon, Besançon, France

family: Kalbacher

full_name: Elsa Kalbacher

given: Elsa

name: Nordic Society of Gynaecological Oncology and Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

family: Mirza

full_name: Mansoor Raza Mirza

given: Mansoor Raza

name: Servicio de Oncologıa Medica, Fundacion Instituto Valenciano de Oncologıa, Valencia, Spain

family: Romero

full_name: Ignacio Romero

given: Ignacio

name: CHU Université catholique de Louvain Namur, Sainte-Elisabeth, Namur, Belgium

name: University of Botswana, Gaborone, Botswana

family: Vuylsteke

full_name: Peter Vuylsteke

given: Peter

family: Coleman

full_name: Robert L. Coleman

given: Robert L.

name: Onkologisches Therapiezentrum am Krankenhaus Jerusalem, Hamburg, Germany

family: Hilpert

full_name: Felix Hilpert

given: Felix

name: Princess Margaret Cancer Centre, Toronto, Ontario, Canada

family: Oza

full_name: Amit M. Oza

given: Amit M.

name: Dutch Gynaecological Oncology Group, Amsterdam University Medical Centers, Amsterdam, the Netherlands

family: Westermann

full_name: Anneke Westermann

given: Anneke

name: Department of Gynaecological Oncology, Royal Adelaide Hospital, Adelaide, South Australia 5005, Australia

family: Oehler

full_name: Martin K. Oehler

given: Martin K.

name: Istituto Nazionale Tumori Fondazione Pascale IRCCS, Naples, Italy

family: Pignata

full_name: Sandro Pignata

given: Sandro

family: Aghajanian

full_name: Carol Aghajanian

given: Carol

name: Dipartimento Medicina e Chirurgia, Università Milano-Bicocca, Programma Ginecologia Oncologica Istituto Europeo Oncologia, IRCCS, Milan, Italy

family: Colombo

full_name: Nicoletta Colombo

given: Nicoletta

family: Drill

full_name: Esther Drill

given: Esther

name: First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic

family: Cibula

full_name: David Cibula

given: David

name: Stephenson Cancer Center at The University of Oklahoma Health Sciences Center, Oklahoma City, OK

family: Moore

full_name: Kathleen N. Moore

given: Kathleen N.

family: Christy-Bittel

full_name: Janna Christy-Bittel

given: Janna

name: Vall d'Hebron University Hospital, Barcelona, Spain

family: del Campo

full_name: Josep M. del Campo

given: Josep M.

name: University Clinic for Gynaecology and Obstetrics, Medical University of Innsbruck, Innsbruck 6020, Austria

family: Berger

full_name: Regina Berger

given: Regina

name: Department of Obstetrics and Gynecology, Medical University of Innsbruck, Austrian AGO, Innsbruck, Austria

family: Marth

full_name: Christian Marth

given: Christian

name: Center for Oncological Surgery, European Competence Center for Ovarian Cancer Campus Virchow Klinikum and Benjamin Franklin Charité Comprehensive Cancer Center , Medical University of Berlin, Berlin, Germany

family: Sehouli

full_name: Jalid Sehouli

name: The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute, Columbus, OH

name: Biodonostia HRI, Osasun Ikerketa Insitutua, Insituto de Investigacion Sanitaria, San Sebastián, Gipuzkoa, Spain

name: Department for Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway

name: Department of Medical Oncology, The Christie National Health Service Foundation Trust, and University of Manchester, Manchester, United Kingdom

name: Centre Léon Bérard, Netsarc Network, Université Claude Bernard Lyon 1, Lyon, France

name: Belgium and Luxemburg Gynaecological Oncology Group, University Hospitals Leuven, Leuven, Belgium

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: MILO/ENGOT-ov11: Binimetinib Versus Physician’s Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum

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

location_country:
Italy
Austria
United States
Sweden
Netherlands
Germany
Finland
France
Czechia
Poland
Norway
Hungary
Australia
Belgium
Ireland
Spain
Denmark
Canada
United Kingdom

location_facility: Ospedale Santa Maria delle Croci - Oculistica

location_facility: Radiology at Hospital Univeristari de Bellvitge

location_facility: Hillcrest Hospital Hirsch Cancer Center Pharmacy

location_facility: UT Southwestern Medical Center-Clements University Hospital

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Mater Misericordiae Health Services Brisbane Limited

location_facility: Dipartimento di Scienze Chirurgiche per le Patologie della Testa e del Collo - UOC di Oculistica

location_facility: Ospedale Santa Maria delle Croci - Unita Operativa di Oncologia

location_facility: Ospedale San Raffaele - Unita Operativa di Oculistica

location_facility: Stephenson Cancer Center(clinic location)

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Orszagos Onkologiai Intezet Kozponti Aneszteziologiai es Intenzivterapias Osztaly

location_facility: Struttura Complessa di Oftalmologia Policlinico S. Orsola-Malpighi

location_facility: University of Iowa Hospitals and Clinics

location_facility: Fairview Hospital Moll Pavilion Cancer Center

location_facility: Avd. for gynekologisk kreft, Radiumhospitalet

location_facility: University of Cincinnati Physicians Company

location_facility: Azienda Ospedaliera Sant' Andrea - Unita Operativa Semplice di Patologia Vitreo-Retinica

location_facility: Centre d'Ophtalmologie du LEZ Centre Medical Les Roques

location_facility: Memorial Sloan Kettering Cancer Center Westchester at West Harrison

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Ospedale Civile degli Infermi - Unita Operativa di Oncologia Medica

location_facility: Istituto Nazionale Tumori di Napoli, "G.Pascale" , Oncologia Medica, Dipartimento Uro-Ginecologico

location_facility: Semmelweis Egyetem AOK Szemeszeti Klinika

location_facility: Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly

location_facility: Spedali Civili di Brescia - Struttura Complessa Clinicizzata - U.O.di Oculistica

location_facility: Azienda Ospedaliera Vincenzo Monaldi di Napoli - U.O.C. di Oculistica

location_facility: Oncology Research Associates, PLLC d/b/a Pinnacle Oncology Hematology

location_facility: James Cancer Hospital & Solove Research Institute

location_facility: Hospital de Sant Joan Despi Moises Broggi

location_facility: UCLA Hematology - Oncology Clinic - Westlake Village

location_facility: Ophthalmology at Instituto Oftalmologico Integral

location_facility: UCLA Hematology/Oncology Clinic - Santa Monica

location_facility: Le Confluent - Nouvelles Cliniques Nantaises

location_facility: University of California, Irvine/UC Irvine Health

location_facility: Policlinico Umberto I - Università Sapienza

location_facility: Centro di Riferimento Oncologico - Struttura Operativa Complessa (SOC)- Oncologia Medica C

location_facility: Ophthalmology at Hospital Universitari i Politecnic La Fe de Valencia

location_facility: University Medical Center Groningen, Medical Oncology

location_facility: University of California Los Angeles, Hematology-Oncology Clinic

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: Centre Hospitalier de l'Universite de Montreal (Chum) - Hopital Notre-Dame

location_facility: UT Southwestern Medical Center-Zale Lipshy University Hospital

location_facility: Ospedale Civile degli Infermi - Servizio di Oculistica

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori - SC Oncologia Ginecologica

location_facility: Juravinski Cancer Center, Department of Oncology

location_facility: Universita degli Studi Federico II di Napoli Dipartimento di Neuroscienze Scienze

location_facility: Ospedale Umberto I - Unita Operativa di Oncologia

location_facility: Montefiore Medical Center - Centennial Women's Health

location_facility: Hospital Universitario Reina Sofía/ Provincial

location_facility: Universita degli Studi Federico II di Napoli Oncologia Medica

location_facility: Istituto Nazionale Tumori Regina Elena - Oncologia Medica A

location_facility: Instituto de Oftalmologia y Hospital La Arruzafa

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly

location_facility: Montefiore Medical Center - Einstein Center for Cancer Care

location_facility: Clinique et Maternite Sainte-Elisabeth Namur

location_facility: Institut de Cancerologie de I'Ouest - Rene Gauducheau

location_facility: Fundacion IVO-Instituto Valenciano de Oncologia

location_facility: Admin.Office/Study Supplies Mailing Address: UCLA Medicine Hematology-Oncology

location_facility: NCT Nationales Centrum für Tumorerkrankungen Heidelberg

location_facility: Montefiore Medical Center, Green Medical Arts Pavilion

location_facility: Klinik fur Frauenheilkunde und Geburtshilfe

location_facility: Azienda Opsedaliera S. Maria Degli Angeli Pordenone-Dipartimento di Chirurgia Specialistica -

location_facility: SSD Oncologia Medica Addarii-Zamagni - Policlinico S. Orsola-Malpighi

location_facility: University of Colorado Denver, University of Colorado Cancer Center

location_facility: UCLA Hematology- Oncology Clinic - Valencia

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Georgia Regents University Cancer Center

location_facility: Radiology at Centro Medico Sanitas Ressalta

location_facility: British Columbia Cancer Agency - Vancouver Centre

location_facility: Fairview Hospital Moll Pavilion Pharmacy

location_facility: Institut Paoli Calmettes - Departement d'Oncologie Medicale

location_facility: St. Vincent Hospital and Health Care Center, Inc.

location_facility: Stefanie Spielman Comprehensive Breast Cancer

location_facility: Associated Vitreoretinal and Uveitis Consultants


title: A Prospective Randomized Phase III Trial of Carboplatin/Gemcitabine/Bevacizumab vs. Carboplatin/Pegylated Liposomal Doxorubicin/Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer

summary: Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and PLD/carboplatin.

ReferenceType: result

ReferenceCitation: Pfisterer J, Shannon CM, Baumann K, Rau J, Harter P, Joly F, Sehouli J, Canzler U, Schmalfeldt B, Dean AP, Hein A, Zeimet AG, Hanker LC, Petit T, Marmé F, El-Balat A, Glasspool R, de Gregorio N, Mahner S, Meniawy TM, Park-Simon TW, Mouret-Reynier MA, Costan C, Meier W, Reinthaller A, Goh JC, L'Haridon T, Baron Hay S, Kommoss S, du Bois A, Kurtz JE; AGO-OVAR 2.21/ENGOT-ov 18 Investigators. Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial. Lancet Oncol. 2020 May;21(5):699-709. doi: 10.1016/S1470-2045(20)30142-X. Epub 2020 Apr 16.

family: Pfisterer

full_name: Jacobus Pfisterer

given: Jacobus

family: Shannon

full_name: Catherine M Shannon

given: Catherine M

family: Baumann

full_name: Klaus Baumann

given: Klaus

family: Rau

full_name: Joern Rau

given: Joern

family: Harter

full_name: Philipp Harter

given: Philipp

family: Joly

full_name: Florence Joly

given: Florence

given: Jalid

family: Canzler

full_name: Ulrich Canzler

given: Ulrich

family: Schmalfeldt

full_name: Barbara Schmalfeldt

given: Barbara

family: Dean

full_name: Andrew P Dean

given: Andrew P

family: Hein

full_name: Alexander Hein

given: Alexander

family: Zeimet

full_name: Alain G Zeimet

given: Alain G

family: Hanker

full_name: Lars C Hanker

given: Lars C

family: Petit

full_name: Thierry Petit

given: Thierry

family: Marmé

full_name: Frederik Marmé

given: Frederik

family: El-Balat

full_name: Ahmed El-Balat

given: Ahmed

family: Glasspool

full_name: Rosalind Glasspool

given: Rosalind

family: de Gregorio

full_name: Nikolaus de Gregorio

given: Nikolaus

family: Mahner

full_name: Sven Mahner

given: Sven

family: Meniawy

full_name: Tarek M Meniawy

given: Tarek M

family: Park-Simon

full_name: Tjoung-Won Park-Simon

given: Tjoung-Won

family: Mouret-Reynier

full_name: Marie-Ange Mouret-Reynier

given: Marie-Ange

family: Costan

full_name: Cristina Costan

given: Cristina

repositories_institution: The University of Glasgow - Enlighten: Publications

location_country:
Austria
France
Australia
Belgium
Germany
United Kingdom

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: MUG-Universitätsklinik für Frauenheilkunde Graz

location_facility: Schwerpunktpraxis für Onkologie / Hämatologie

location_facility: Hôpital Privé Villeneuve d'Ascq, Institut de Canérologie

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Hôpital Michallon, Centre Hospitalier Universitaire de Grenoble

location_facility: Klinikum Schaumburg, Krankenhaus Stadthagen

location_facility: Clinique Mutualiste de l'Estuaire, Cité Sanitaire

location_facility: The Beatson West of Scotland Cancer Center

location_facility: SALK-LKH Salzburg, Universitätsklinik für Frauenheilkunde und Geburtshilfe


title: A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients With Completely Resected Stage I or IIA Non-Squamous Non-Small Cell Lung Cancer Identified as Intermediate or High Risk by a 14-Gene Prognostic Assay

summary: The optimal treatment for Stage I or Stage IIA non-small cell lung cancer (NSCLC) remains controversial. Radiographic surveillance alone has been recommended for stage I and stage IIA patients after the tumor is removed surgically from the lung, and this standard has been based on the fact that no previous clinical trial has demonstrated a benefit for Stage I or Stage IIA NSCLC patients who receive post-operative chemotherapy. These patients, however, have a substantial risk of death within five years after operation, ranging from approximately 30% to 45%, largely due to metastatic disease that is present immediately after surgery but that is undetectable by conventional methods. Some leading organizations therefore currently recommend post-operative chemotherapy as an alternative standard of care in Stage I or Stage IIA NSCLC patients who are considered to be at particularly high-risk. Up until now, however, there has not been a well-validated means to identify stage I and stage IIA NSCLC patients at high risk of death within five years after operation. A new prognostic tool, a 14-Gene Prognostic Assay, which has been validated and definitively demonstrated in large scale studies to identify intermediate and high-risk stage I or Stage IIA patients with non-squamous NSCLC, is now available to all clinicians through a CLIA-certified laboratory. It is therefore now possible to compare the outcomes of patients randomly assigned to one or the other of these competing standards of care.

status: Recruiting

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Kratz JR, He J, Van Den Eeden SK, Zhu ZH, Gao W, Pham PT, Mulvihill MS, Ziaei F, Zhang H, Su B, Zhi X, Quesenberry CP, Habel LA, Deng Q, Wang Z, Zhou J, Li H, Huang MC, Yeh CC, Segal MR, Ray MR, Jones KD, Raz DJ, Xu Z, Jahan TM, Berryman D, He B, Mann MJ, Jablons DM. A practical molecular assay to predict survival in resected non-squamous, non-small-cell lung cancer: development and international validation studies. Lancet. 2012 Mar 3;379(9818):823-32. doi: 10.1016/S0140-6736(11)61941-7. Epub 2012 Jan 27.

ReferenceCitation: Woodard GA, Wang SX, Kratz JR, Zoon-Besselink CT, Chiang CY, Gubens MA, Jahan TM, Blakely CM, Jones KD, Mann MJ, Jablons DM. Adjuvant Chemotherapy Guided by Molecular Profiling and Improved Outcomes in Early Stage, Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2018 Jan;19(1):58-64. doi: 10.1016/j.cllc.2017.05.015. Epub 2017 May 31.

ReferenceCitation: Kratz JR, Van den Eeden SK, He J, Jablons DM, Mann MJ. A prognostic assay to identify patients at high risk of mortality despite small, node-negative lung tumors. JAMA. 2012 Oct 24;308(16):1629-31. doi: 10.1001/jama.2012.13551.

lead_sponsor: Razor Genomics

location_country:
Germany
United States
France

location_facility: Lung Clinic Grosshansdorf-Department of Thoracic Oncology

location_facility: Hôpital Nord Service d'Oncologie Multidisciplinaire & Innovations Thérapeutiques

location_facility: Pius-Hospital Oldenburg Medizinischer Campus Universität Oldenburg

location_facility: Clinique PneumologiqueHôpital Charles Nicolle1 rue de Germont

location_facility: Unité de recherche clinique Hôpital APHP Ambroise Paré

location_facility: Infirmière de Recherche Clinique Service de Pneumologie

location_facility: BCRM Toulon HIA Sainte Anne-Unité de Recherche Clinique

location_facility: Groupe Hospitalier Région de Mulhouse Sud -Alsace

location_facility: Chu de Poitiers -Attachée de Recherche Clinique Pôle Régional de Cancérologie

location_facility: Hôpital Larrey-Bureau de recherche clinique

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH - Universitätsklinik -

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Munich-Gauting -Thoracic Oncology Department Asklepios Lung Clinic

location_facility: CHRU Besançon- Pneumologie Oncologie Thoracique

intervention_type: Other


title: Medical Records Review to Describe the Patterns of KRAS Testing and Vectibix Use in Europe

summary: This non-interventional retrospective medical record review study will assess the prevalence of KRAS testing and the impact of the KRAS test result on patterns of Vectibix use in patients with metastatic colorectal cancer (mCRC) treated with Vectibix in selected European countries over 3 rounds. As the optimal use of Vectibix also requires accurate KRAS mutation testing, this study will also assess data from the laboratory that performed the KRAS test. The study will also monitor changes in the pattern of Vectibix treatment between the different rounds of the study.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Amgen

location_country:
Italy
Sweden
Netherlands
France
Belgium
Spain
Denmark
Germany
Czech Republic


ReferenceCitation: Finn RS, Merle P, Granito A, Huang YH, Bodoky G, Pracht M, Yokosuka O, Rosmorduc O, Gerolami R, Caparello C, Cabrera R, Chang C, Sun W, LeBerre MA, Baumhauer A, Meinhardt G, Bruix J. Outcomes of sequential treatment with sorafenib followed by regorafenib for HCC: Additional analyses from the phase III RESORCE trial. J Hepatol. 2018 Aug;69(2):353-358. doi: 10.1016/j.jhep.2018.04.010. Epub 2018 Apr 26.

family: Finn

full_name: Richard S. Finn

given: Richard S.

family: Merle

full_name: Philippe Merle

given: Philippe

family: Granito

full_name: Alessandro Granito

given: Alessandro

family: Huang

full_name: Yi-Hsiang Huang

given: Yi-Hsiang

family: Bodoky

full_name: György Bodoky

given: György

family: Pracht

full_name: Marc Pracht

given: Marc

family: Yokosuka

full_name: Osamu Yokosuka

given: Osamu

family: Rosmorduc

full_name: Olivier Rosmorduc

given: Olivier

family: Gerolami

full_name: René Gerolami

given: René

family: Caparello

full_name: Chiara Caparello

given: Chiara

family: Cabrera

full_name: Roniel Cabrera

given: Roniel

family: Chang

full_name: Charissa Chang

given: Charissa

family: Sun

full_name: Weijing Sun

given: Weijing

family: LeBerre

full_name: Marie-Aude LeBerre

given: Marie-Aude

family: Baumhauer

full_name: Annette Baumhauer

given: Annette

family: Meinhardt

full_name: Gerold Meinhardt

given: Gerold

family: Bruix

full_name: Jordi Bruix

given: Jordi

journal_name: Journal of Hepatology

ReferenceCitation: Bruix J, Qin S, Merle P, Granito A, Huang YH, Bodoky G, Pracht M, Yokosuka O, Rosmorduc O, Breder V, Gerolami R, Masi G, Ross PJ, Song T, Bronowicki JP, Ollivier-Hourmand I, Kudo M, Cheng AL, Llovet JM, Finn RS, LeBerre MA, Baumhauer A, Meinhardt G, Han G; RESORCE Investigators. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Jan 7;389(10064):56-66. doi: 10.1016/S0140-6736(16)32453-9. Epub 2016 Dec 6. Erratum in: Lancet. 2017 Jan 7;389(10064):36.

family: Qin

full_name: Shukui Qin

given: Shukui

ReferenceCitation: Teufel M, Seidel H, Köchert K, Meinhardt G, Finn RS, Llovet JM, Bruix J. Biomarkers Associated With Response to Regorafenib in Patients With Hepatocellular Carcinoma. Gastroenterology. 2019 May;156(6):1731-1741. doi: 10.1053/j.gastro.2019.01.261. Epub 2019 Feb 6.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

ipd_sharing_description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Argentina
Korea, Republic of
Switzerland
Netherlands
Singapore
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Spain

title: A Randomized, Double Blind, Placebo Controlled, Multicenter Phase III Study of Regorafenib in Patients With Hepatocellular Carcinoma (HCC) After Sorafenib

summary: The objective of this study was to evaluate efficacy and safety of regorafenib in patients with advanced liver cancer who had progressed after sorafenib treatment. Patients were treated with regorafenib or placebo using a 2:1 randomization scheme.


type: Registry Identifier

title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease

acronym: FOURIER

summary: The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.

ReferenceCitation: Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.

ReferenceCitation: Fonarow GC, Keech AC, Pedersen TR, Giugliano RP, Sever PS, Lindgren P, van Hout B, Villa G, Qian Y, Somaratne R, Sabatine MS. Cost-effectiveness of Evolocumab Therapy for Reducing Cardiovascular Events in Patients With Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2017 Oct 1;2(10):1069-1078. doi: 10.1001/jamacardio.2017.2762. Erratum in: JAMA Cardiol. 2017 Oct 1;2(10):1170.

ReferenceCitation: Fonarow GC, van Hout B, Villa G, Arellano J, Lindgren P. Updated Cost-effectiveness Analysis of Evolocumab in Patients With Very High-risk Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2019 Jul 1;4(7):691-695. doi: 10.1001/jamacardio.2019.1647.

ReferenceCitation: Oyama K, Giugliano RP, Tang M, Bonaca MP, Saver JL, Murphy SA, Ruzza A, Keech AC, Sever PS, Sabatine MS, Bergmark BA. Effect of evolocumab on acute arterial events across all vascular territories : results from the FOURIER trial. Eur Heart J. 2021 Sep 19. pii: ehab604. doi: 10.1093/eurheartj/ehab604. [Epub ahead of print]

journal_name: European Heart Journal

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: OUP accepted manuscript

ReferenceCitation: Oyama K, Furtado RHM, Fagundes A Jr, Zelniker TA, Tang M, Kuder J, Murphy SA, Hamer A, Wang H, Keech AC, Giugliano RP, Sabatine MS, Bergmark BA. Effect of Evolocumab on Complex Coronary Disease Requiring Revascularization. J Am Coll Cardiol. 2021 Jan 26;77(3):259-267. doi: 10.1016/j.jacc.2020.11.011. Epub 2020 Nov 13.

family: Oyama

full_name: Kazuma Oyama

given: Kazuma

family: Furtado

full_name: Remo H.M. Furtado

given: Remo H.M.

family: Fagundes

full_name: Antonio Fagundes

given: Antonio

suffix: Jr.

family: Zelniker

full_name: Thomas A. Zelniker

given: Thomas A.

family: Tang

full_name: Minao Tang

given: Minao

family: Kuder

full_name: Julia Kuder

given: Julia

family: Murphy

full_name: Sabina A. Murphy

given: Sabina A.

family: Hamer

full_name: Andrew Hamer

given: Andrew

family: Wang

full_name: Huei Wang

given: Huei

family: Keech

full_name: Anthony C. Keech

given: Anthony C.

family: Giugliano

full_name: Robert P. Giugliano

given: Robert P.

family: Sabatine

full_name: Marc S. Sabatine

given: Marc S.

family: Bergmark

full_name: Brian A. Bergmark

given: Brian A.

journal_name: Journal of the American College of Cardiology

title: Effect of Evolocumab on Complex Coronary Disease Requiring Revascularization

ReferenceCitation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10:CD011748. doi: 10.1002/14651858.CD011748.pub3.

name: Institute of Cardiovascular Science; University College London; London UK

name: Department of Cardiology, Division Heart and Lungs; UMC Utrecht; Utrecht Netherlands

family: Schmidt

full_name: Amand F Schmidt

given: Amand F

name: Department of Clinical Pharmacology and Therapeutics; University College London Hospital; London UK

family: Carter

full_name: John-Paul L Carter

given: John-Paul L

name: Department of Non-communicable Disease Epidemiology; London School of Hygiene & Tropical Medicine; London UK

family: Pearce

full_name: Lucy S Pearce

given: Lucy S

name: The Department of Medicine (Cardiology) and the Department of Preventive Medicine; Northwestern University Feinberg School of Medicine; Chicago Illinois USA

family: Wilkins

full_name: John T Wilkins

name: Medicines Discovery Catapult; Alderly Edge UK

name: Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC); VA Boston Healthcare System; Boston Massachusetts USA

repository_institution: University College London - UCL Discovery

repositories_institution: University College London - UCL Discovery

repositories_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

title: PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease

ReferenceCitation: Deedwania P, Murphy SA, Scheen A, Badariene J, Pineda AL, Honarpour N, Keech AC, Sever PS, Pedersen TR, Sabatine MS, Giugliano RP. Efficacy and Safety of PCSK9 Inhibition With Evolocumab in Reducing Cardiovascular Events in Patients With Metabolic Syndrome Receiving Statin Therapy: Secondary Analysis From the FOURIER Randomized Clinical Trial. JAMA Cardiol. 2021 Feb 1;6(2):139-147. doi: 10.1001/jamacardio.2020.3151.

name: University of California School of Medicine, San Francisco, Fresno

name: TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

name: Department of Medicine, CHU Liège, Liège University, Liège, Belgium

name: Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania

name: Sydney Medical School, NHMRC Clinical Trials Centre, University of Sydney, Australia

name: National Heart and Lung Institute, Imperial College London, United Kingdom

name: Oslo University Hospital, Ullevål and Medical Faculty, University of Oslo, Norway

ReferenceCitation: Gencer B, Mach F, Murphy SA, De Ferrari GM, Huber K, Lewis BS, Ferreira J, Kurtz CE, Wang H, Honarpour N, Keech AC, Sever PS, Pedersen TR, Sabatine MS, Giugliano RP. Efficacy of Evolocumab on Cardiovascular Outcomes in Patients With Recent Myocardial Infarction: A Prespecified Secondary Analysis From the FOURIER Trial. JAMA Cardiol. 2020 Aug 1;5(8):952-957. doi: 10.1001/jamacardio.2020.0882. Erratum in: JAMA Cardiol. 2021 Aug 1;6(8):980.

name: TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts

name: Cardiology Division, Geneva University Hospitals, Geneva, Switzerland

name: Division of Cardiology Città della Salute e della Scienza, Department of Medical Sciences, University of Torino, Turin, Italy

name: Department of Medicine, Cardiology and Intensive Care Medicine and Sigmund Freud University, Medical School, Vienna, Austria

name: Lady Davis Carmel Medical Center, Haifa, Israel

name: Hospital de Santa Cruz, Lisbon, Portugal

name: Sydney Medical School, National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia

name: National Heart and Lung Institute, Imperial College London, London, United Kingdom

name: Oslo University Hospital, Ulleval and Medical Faculty, University of Oslo, Oslo, Norway

title: Efficacy of Evolocumab on Cardiovascular Outcomes in Patients With Recent Myocardial Infarction

ReferenceCitation: Bergmark BA, O'Donoghue ML, Murphy SA, Kuder JF, Ezhov MV, Ceška R, Gouni-Berthold I, Jensen HK, Tokgozoglu SL, Mach F, Huber K, Gaciong Z, Lewis BS, Schiele F, Jukema JW, Pedersen TR, Giugliano RP, Sabatine MS. An Exploratory Analysis of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibition and Aortic Stenosis in the FOURIER Trial. JAMA Cardiol. 2020 Jun 1;5(6):709-713. doi: 10.1001/jamacardio.2020.0728.

name: TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts

name: National Medical Research Center of Cardiology, Moscow, Russia

name: Third Internal Medicine Clinic, Center for Preventive Cardiology, University General Hospital, First Medical Faculty, Charles University, Prague, Czech Republic

name: Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany

name: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark

name: Department of Clinical Medicine, Health, Aarhus University, Aarhus, Denmark

name: Department of Cardiology, Hacettepe University, Ankara, Turkey

name: Cardiology and Intensive Care Medicine, Wilhelminenhospital, Third Department of Medicine, Sigmund Freud University, Medical Faculty, Vienna, Austria

name: Department of Internal Medicine, Hypertension and Vascular Disease, the Medical University of Warsaw, Warsaw, Poland

name: The Ruth and Bruce Rappaport School of Medicine, Lady Davis Carmel Medical Center, Technion-IIT, Haifa, Israel

name: University Hospital Center Besançon, Besançon, France

name: Department of Cardiology, Leiden University Medical Center, the Netherlands

name: Netherlands Heart Institute, Utrecht, the Netherlands

name: Oslo University Hospital, Ullevål and Medical Faculty, University of Oslo, Oslo, Norway

ReferenceCitation: Wiviott SD, Giugliano RP, Morrow DA, De Ferrari GM, Lewis BS, Huber K, Kuder JF, Murphy SA, Forni DM, Kurtz CE, Honarpour N, Keech AC, Sever PS, Pedersen TR, Sabatine MS. Effect of Evolocumab on Type and Size of Subsequent Myocardial Infarction: A Prespecified Analysis of the FOURIER Randomized Clinical Trial. JAMA Cardiol. 2020 Jul 1;5(7):787-793. doi: 10.1001/jamacardio.2020.0764.

name: Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts

name: Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts

name: Department of Medical Sciences, University of Torino, Cardiology AOU Città della Salute e della Scienza, Torino, Italy

name: Sydney Medical School, National Health and Medical Research Council Clinical Trials Center, University of Sydney, Sydney Australia

name: National Heart and Lung Institute, Imperial College, London, United Kingdom

name: Oslo University Hospital, Ulleval and Medical Faculty, University of Oslo, Oslo Norway

title: Effect of Evolocumab on Type and Size of Subsequent Myocardial Infarction

ReferenceCitation: Giugliano RP, Pedersen TR, Saver JL, Sever PS, Keech AC, Bohula EA, Murphy SA, Wasserman SM, Honarpour N, Wang H, Lira Pineda A, Sabatine MS; FOURIER Investigators. Stroke Prevention With the PCSK9 (Proprotein Convertase Subtilisin-Kexin Type 9) Inhibitor Evolocumab Added to Statin in High-Risk Patients With Stable Atherosclerosis. Stroke. 2020 May;51(5):1546-1554. doi: 10.1161/STROKEAHA.119.027759. Epub 2020 Apr 21.

name: From the TIMI (Thrombolysis in Myocardial Infarction) Study Group, Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (R.P.G., E.A.B., S.A.M., M.S.S.)

name: Oslo Universitetssykehus HF, Endocrinology–Morbid Obesity and Preventive Medicine, Norway (T.R.P.)

name: Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at UCLA, Los Angeles, CA (J.L.S.)

name: National Heart and Lung Institute, Imperial College London, United Kingdom (P.S.S.)

name: Sydney Medical School, National Health and Medical Research Council Clinical Trials Centre, Australia (A.C.K.)

name: Amgen, Inc, Global Development, Thousand Oaks, CA (S.M.W., N.H., H.W., A.L.P.).

ReferenceCitation: Charytan DM, Sabatine MS, Pedersen TR, Im K, Park JG, Pineda AL, Wasserman SM, Deedwania P, Olsson AG, Sever PS, Keech AC, Giugliano RP; FOURIER Steering Committee and Investigators. Efficacy and Safety of Evolocumab in Chronic Kidney Disease in the FOURIER Trial. J Am Coll Cardiol. 2019 Jun 18;73(23):2961-2970. doi: 10.1016/j.jacc.2019.03.513. Erratum in: J Am Coll Cardiol. 2019 Aug 27;74(8):1162-1166.

title: Efficacy and Safety of Evolocumab in Chronic Kidney Disease in the FOURIER Trial

ReferenceCitation: Murphy SA, Pedersen TR, Gaciong ZA, Ceska R, Ezhov MV, Connolly DL, Jukema JW, Toth K, Tikkanen MJ, Im K, Wiviott SD, Kurtz CE, Honarpour N, Giugliano RP, Keech AC, Sever PS, Sabatine MS. Effect of the PCSK9 Inhibitor Evolocumab on Total Cardiovascular Events in Patients With Cardiovascular Disease: A Prespecified Analysis From the FOURIER Trial. JAMA Cardiol. 2019 Jul 1;4(7):613-619. doi: 10.1001/jamacardio.2019.0886.

name: TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, Masschusetts

name: Department of Internal Medicine, Hypertension and Vascular Diseases, The Medical University of Warsaw, Warsaw, Poland

name: National Cardiology Research Center, Moscow, Russia

name: Birmingham City and Sandwell Hospitals and the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, England

name: Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands

name: First Department of Medicine, University of Pecs, Medical School, Pecs, Hungary

name: Folkhälsan Research Center, University of Helsinki, Helsinki, Finland

name: Imperial College London, London, England

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

title: Effect of the PCSK9 Inhibitor Evolocumab on Total Cardiovascular Events in Patients With Cardiovascular Disease

ReferenceCitation: O'Donoghue ML, Fazio S, Giugliano RP, Stroes ESG, Kanevsky E, Gouni-Berthold I, Im K, Lira Pineda A, Wasserman SM, Češka R, Ezhov MV, Jukema JW, Jensen HK, Tokgözoğlu SL, Mach F, Huber K, Sever PS, Keech AC, Pedersen TR, Sabatine MS. Lipoprotein(a), PCSK9 Inhibition, and Cardiovascular Risk. Circulation. 2019 Mar 19;139(12):1483-1492. doi: 10.1161/CIRCULATIONAHA.118.037184.

name: TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital, Boston, MA (M.L.O., R.P.G., E.K., K.A.I., M.S.S.).

name: Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health & Science University, Portland (S.F.).

name: Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands (E.S.G.S.).

name: Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Germany (I.G.-B.).

name: Amgen, Thousand Oaks, CA (A.L.P., S.M.W.).

name: Center for Preventive Cardiology, 3rd Internal Medicine Clinic, University General Hospital and Charles University 1st Medical Faculty, Prague, Czech Republic (R.C.).

name: National Cardiology Research Center, Moscow, Russia (M.V.E.).

name: Department of Cardiology, Leiden University Medical Center, The Netherlands (J.W.J.).

name: Department of Cardiology, Aarhus University Hospital and Department of Clinical Medicine, Health, Aarhus University, Denmark (H.K.J.).

name: Cardiovascular Division, Hacettepe University, Ankara, Turkey (S.L.T.).

name: Cardiology Division, University of Geneva, Switzerland (F.M.).

name: 3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital and Sigmund Freud University, Medical Faculty, Vienna, Austria (K.H.).

name: Sydney Medical School, National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Australia (A.C.K.).

name: Oslo University Hospital, Ullevål and Medical Faculty, University of Oslo, Norway (T.R.P.).

title: Lipoprotein(a), PCSK9 Inhibition, and Cardiovascular Risk

ReferenceCitation: Qamar A, Giugliano RP, Keech AC, Kuder JF, Murphy SA, Kurtz CE, Wasserman SM, Sever PS, Pedersen TR, Sabatine MS. Interindividual Variation in Low-Density Lipoprotein Cholesterol Level Reduction With Evolocumab: An Analysis of FOURIER Trial Data. JAMA Cardiol. 2019 Jan 1;4(1):59-63. doi: 10.1001/jamacardio.2018.4178.

title: Interindividual Variation in Low-Density Lipoprotein Cholesterol Level Reduction With Evolocumab

ReferenceCitation: Martin SS, Giugliano RP, Murphy SA, Wasserman SM, Stein EA, Ceška R, López-Miranda J, Georgiev B, Lorenzatti AJ, Tikkanen MJ, Sever PS, Keech AC, Pedersen TR, Sabatine MS. Comparison of Low-Density Lipoprotein Cholesterol Assessment by Martin/Hopkins Estimation, Friedewald Estimation, and Preparative Ultracentrifugation: Insights From the FOURIER Trial. JAMA Cardiol. 2018 Aug 1;3(8):749-753. doi: 10.1001/jamacardio.2018.1533.

name: Ciccarone Center for the Prevention of Cardiovascular Disease, Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, Maryland

name: Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, Massachusetts

name: Harvard Medical School, Boston, Massachusetts

name: Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio

name: Center of Preventive Cardiology, 3rd Department Internal Medicine, University General Hospital and First Medical Faculty, Prague, Czech Republic

name: Lipids and Atherosclerosis Unit, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofía University Hospital, University of Cordoba, Cordoba, Spain

name: CIBER Fisiopatología de la Obesidad y Nutrición (CIBERObN), Cordoba, Spain

name: Department of Cardiology, National Heart Hospital, Sofia, Bulgaria

name: Cardiology Department, Cordoba Hospital, Cordoba, Argentina

name: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, England

ReferenceCitation: Sabatine MS, De Ferrari GM, Giugliano RP, Huber K, Lewis BS, Ferreira J, Kuder JF, Murphy SA, Wiviott SD, Kurtz CE, Honarpour N, Keech AC, Sever PS, Pedersen TR. Clinical Benefit of Evolocumab by Severity and Extent of Coronary Artery Disease: Analysis From FOURIER. Circulation. 2018 Aug 21;138(8):756-766. doi: 10.1161/CIRCULATIONAHA.118.034309.

name: TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (M.S.S., R.P.G., J.F.K., S.A.M., S.D.W.)

name: Department of Molecular Medicine, University of Pavia and Cardiac Intensive Care Unit and Laboratories for Experimental Cardiology, Istituto di Ricerca e Cura a Carattere Scientifico Fondazione Policlinico San Matteo, Italy (G.M.D.F.)

name: Third Department of Medicine, Cardiology, and Intensive Care Medicine and Sigmund Freud University, Medical School, Vienna, Austria (K.H.)

name: Lady Davis Carmel Medical Center, Haifa, Israel (B.S.L.)

name: Hospital de Santa Cruz, Lisbon, Portugal (J.F.)

name: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, UK (P.S.S.)

name: Oslo University Hospital, Ulleval and Medical Faculty, University of Oslo, Norway (T.R.P.).

title: Clinical Benefit of Evolocumab by Severity and Extent of Coronary Artery Disease

ReferenceCitation: Bohula EA, Giugliano RP, Leiter LA, Verma S, Park JG, Sever PS, Lira Pineda A, Honarpour N, Wang H, Murphy SA, Keech A, Pedersen TR, Sabatine MS. Inflammatory and Cholesterol Risk in the FOURIER Trial. Circulation. 2018 Jul 10;138(2):131-140. doi: 10.1161/CIRCULATIONAHA.118.034032. Epub 2018 Mar 12.

name: TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (E.A.B., R.P.G., J.-G.P., S.A.M., M.S.S.).

name: Li Ka Shing Knowledge Institute, St. Michael’s Hospital, University of Toronto, Ontario, Canada (L.A.L., S.V.).

name: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, United Kingdom (P.S.S.).

name: Amgen, Thousand Oaks, CA (A.L.P., N.H., H.W.).

name: Sydney Medical School, National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Australia (A.K.).

title: Inflammatory and Cholesterol Risk in the FOURIER Trial

ReferenceCitation: Bonaca MP, Nault P, Giugliano RP, Keech AC, Pineda AL, Kanevsky E, Kuder J, Murphy SA, Jukema JW, Lewis BS, Tokgozoglu L, Somaratne R, Sever PS, Pedersen TR, Sabatine MS. Low-Density Lipoprotein Cholesterol Lowering With Evolocumab and Outcomes in Patients With Peripheral Artery Disease: Insights From the FOURIER Trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk). Circulation. 2018 Jan 23;137(4):338-350. doi: 10.1161/CIRCULATIONAHA.117.032235. Epub 2017 Nov 13.

name: Thrombolysis In Myocardial Infarction Study Group, Brigham and Women’s Hospital Heart & Vascular Center, Boston, MA (M.P.B., R.P.G., E.K., J.K., M.S.S.)

name: McGill University, Montreal, and Division of Vascular and Endovascular Surgery, Centre Intégré de la santé et des services sociaux de l’Outaouais, Gatineau, Canada (P.N.)

name: Department of Cardiology, Leiden University Medical Center, the Netherlands (J.W.J.)

name: Lady Davis Carmel Medical Center and Ruth and Bruce Rappaport School of Medicine, Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.)

name: Department of Cardiology, Hacettepe University, Ankara, Turkey (L.T.)

name: Oslo University Hospital, Ullevål and Medical Faculty, University of Oslo, Norway (T.R.P.)

title: Low-Density Lipoprotein Cholesterol Lowering With Evolocumab and Outcomes in Patients With Peripheral Artery Disease

ReferenceCitation: Sabatine MS, Leiter LA, Wiviott SD, Giugliano RP, Deedwania P, De Ferrari GM, Murphy SA, Kuder JF, Gouni-Berthold I, Lewis BS, Handelsman Y, Pineda AL, Honarpour N, Keech AC, Sever PS, Pedersen TR. Cardiovascular safety and efficacy of the PCSK9 inhibitor evolocumab in patients with and without diabetes and the effect of evolocumab on glycaemia and risk of new-onset diabetes: a prespecified analysis of the FOURIER randomised controlled trial. Lancet Diabetes Endocrinol. 2017 Dec;5(12):941-950. doi: 10.1016/S2213-8587(17)30313-3. Epub 2017 Sep 15.

ReferenceCitation: Giugliano RP, Pedersen TR, Park JG, De Ferrari GM, Gaciong ZA, Ceska R, Toth K, Gouni-Berthold I, Lopez-Miranda J, Schiele F, Mach F, Ott BR, Kanevsky E, Pineda AL, Somaratne R, Wasserman SM, Keech AC, Sever PS, Sabatine MS; FOURIER Investigators. Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial. Lancet. 2017 Oct 28;390(10106):1962-1971. doi: 10.1016/S0140-6736(17)32290-0. Epub 2017 Aug 28.

location_country:
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Iceland
Ukraine
India
France
Japan
Lithuania
Poland
Slovakia
Norway
Argentina
Canada
Korea, Republic of
Turkey
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Philippines
Switzerland
Bulgaria
Singapore
Hungary
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Estonia
Latvia


title: A Prospective, Randomized, Open Label, Two Arm Phase III Study to Evaluate Treatment Free Remission (TFR) Rate in Patients With Philadelphia-positive CML After Two Different Durations of Consolidation Treatment With Nilotinib 300mg BID.

acronym: ENESTPath

summary: This study aimed to assess the optimal duration of nilotinib 300 mg twice daily (BID) consolidation treatment in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), in order that patients remained in treatment-free remission (≥MR4.0) without molecular relapse 12 months after starting the Treatment-Free Remission (TFR) phase.

ReferenceCitation: Borghi L, Rosti G, Maggi A, Breccia M, Di Bona E, Iurlo A, La Barba G, Sportoletti P, Albano F, Galimberti S, Rivellini F, Cambrin GR, Capodanno I, Cuneo A, Bonifacio M, Sica S, Arcaini L, Capochiani E, Minotto C, Ciceri F, Crugnola M, Di Caprio L, Supekar S, Elena C, Baccarani M, Vegni E. Perspectives and Emotional Experiences of Patients With Chronic Myeloid Leukemia During ENESTPath Clinical Trial and Treatment-Free Remission: Rationale and Protocol of the Italian Substudy. Front Oncol. 2021 May 26;11:638689. doi: 10.3389/fonc.2021.638689. eCollection 2021.

family: Borghi

full_name: Lidia Borghi

given: Lidia

family: Rosti

full_name: Gianantonio Rosti

given: Gianantonio

family: Maggi

full_name: Alessandro Maggi

given: Alessandro

family: Breccia

full_name: Massimo Breccia

given: Massimo

family: Di Bona

full_name: Eros Di Bona

given: Eros

family: Iurlo

full_name: Alessandra Iurlo

given: Alessandra

family: La Barba

full_name: Gaetano La Barba

given: Gaetano

family: Sportoletti

full_name: Paolo Sportoletti

given: Paolo

family: Albano

full_name: Francesco Albano

given: Francesco

family: Galimberti

full_name: Sara Galimberti

given: Sara

family: Rivellini

full_name: Flavia Rivellini

given: Flavia

family: Cambrin

full_name: Giovanna Rege Cambrin

given: Giovanna Rege

family: Capodanno

full_name: Isabella Capodanno

given: Isabella

family: Cuneo

full_name: Antonio Cuneo

family: Bonifacio

full_name: Massimiliano Bonifacio

given: Massimiliano

family: Sica

full_name: Simona Sica

given: Simona

family: Arcaini

full_name: Luca Arcaini

given: Luca

family: Capochiani

full_name: Enrico Capochiani

given: Enrico

family: Minotto

full_name: Claudia Minotto

given: Claudia

family: Ciceri

full_name: Fabio Ciceri

given: Fabio

family: Crugnola

full_name: Monica Crugnola

given: Monica

family: Di Caprio

full_name: Luigi Di Caprio

given: Luigi

family: Supekar

full_name: Sharon Supekar

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

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

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

location_country:
Finland
Greece
Romania
Belgium
Denmark
France
Poland
Slovakia
Norway
Slovenia
Sweden
Bulgaria
Hungary
Portugal
Germany
United Kingdom
Italy
Austria
Serbia
Czechia
Spain