lead_sponsor: Constellation Pharmaceuticals

location_country:
Italy
Austria
United States
Netherlands
France
Poland
Hungary
Australia
Belgium
Spain
Canada
United Kingdom

location_facility: Mays Cancer Center at UT Health San Antonio MD Anderson

location_facility: CHU DE NIMES _Institut de Cancérologie du Gard

location_facility: London Health Sciences Center - Victoria Hospital

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital

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

location_facility: Loyola University - Cardinal Bernardin Cancer Center

location_facility: ICO Girona - Hospital Universitari de Girona

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Szabolcs Szatmár Bereg Megyei Kórházak és Egyetemi Oktatókórház; Jósa András Oktatókórház, Hematológia

location_facility: USC Clinical Trials Centre Sunshine Coast Haematology and Oncology Clinic

location_facility: Hospital Clínico Universitario De Santiago De Compostela Travesia Choupana S/N

location_facility: Norton Cancer Institute, St. Matthews Campus

location_facility: Peninsula Private Hospital Clinical Trials Unit

location_facility: Franciscan Health/Indiana blood and Marrow Transplantation

location_facility: Weill Cornell Medical College- New York Presbyterian Hospital

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: LKH - Universitätsklinikum Graz; Abteilung für Hämatologie

ipd_sharing: No

title: A Phase 3, Randomized, Double-blind, Active-Control Study of CPI-0610 and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients

summary: A Phase 3, randomized, blinded study comparing CPI-0610 and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been exposed previously to Janus kinase inhibitors (JAKi). CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins. Evidence suggests that inhibition of both BET and JAK pathways can result in synergistic reduction of disease and overall improvement in the prognosis of MF.


title: A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor

summary: This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in patients with recurrent or metastatic head and neck cancer.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: AstraZeneca

location_country:
Peru
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Switzerland
Netherlands
Philippines
Bulgaria
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Spain

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


lead_sponsor: Galderma R&D

location_country:
United States
Switzerland
Netherlands
France
Poland
Belgium
Spain
Canada
Korea, Republic of

acronym: A study to assess the efficacy and safety of nemolizumab in subjects with prurigo nodularis

type: EudraCT Number

source: euctr

title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis

summary: The primary objective is to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN) after a 16-week treatment period.


ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Malaysia
Belgium
Australia
Russian Federation
Taiwan
Ukraine
India
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Netherlands
Hungary
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Israel
Spain
Turkey

acronym: MARIPOSA

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: UPCO Unidade de Pesquisa Clinica em Oncologia

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: Beijing Chest hospital, Capital medical university

location_facility: Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Nizhny Novgorod Regional Oncological Dispensary

location_facility: University of Mississippi Medical Center

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Grand Hôpital de Charleroi, site Notre Dame

location_facility: Başkent University Medical Faculty Adana Application and Research Center

location_facility: Robert-Bosch-Krankenhaus - Klinik Schillerhoehe

location_facility: Peking University International Hospital

location_facility: Third Military Medical University Daping Hospital Cancer Center

location_facility: Tianjin Medical University General Hospital

location_facility: Centro Hospitalar Universitario do Porto, EPE

location_facility: Fundação Antônio Prudente - A.C. Camargo Cancer Center

location_facility: The First People's Hospital Of Changzhou

location_facility: Municipal non-profit enterprise 'Regional Center of Oncology'

location_facility: T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi

location_facility: Municipal Institution 'Odesa Clinical Oncology Dispensary'

location_facility: Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

location_facility: Yaroslavl Regional Clinical Oncology Hospital

location_facility: N.N. Petrov Research Institute Of Oncology

location_facility: Moscow Oncology Research Center n.a. Blokhin

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Sun Yat-Sen Memorial Hospital Sun Yat-sen University

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Private Specialist Hospitals - MedPolonia

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Harbin medical university cancer hospital

location_facility: Oncology Medical Clinics AV Medical group

location_facility: Songklanagarind Hospital, Prince of Songkla University

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: Palo Alto Medical Foundation Research Institute

location_facility: Ventura County Hematology Oncology Specialists

location_facility: The Second Affiliated Hospital of Zhejiang University College of Medicine

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Centro Oncologico Riojano Integral (Cori)

location_facility: Frederick Health Hospital - James M Stockman Cancer Institute

location_facility: Mexico Centre for Clinical Research, S.A. de C.V.

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

location_facility: Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

location_facility: Instituto do Cancer do Estado de Sao Paulo ICESP

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz

location_facility: National Hospital Organization Iwakuni Clinical Center

location_facility: Necmettin Erbakan University Meram Medical Faculty

location_facility: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

location_facility: State Medical Institution 'Republican Clinical Oncological Centre' at Republic of Tatarstan

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Washington University School of Medicine

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: Second Affiliated Hospital, School of Medicine, Zhejiang University

location_facility: Hospital Evangélico de Cachoeiro de Itapemirim

location_facility: Pan American Center for Oncology Trials LLC

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Fundacao Pio Xii - Hospital De Cancer De Barretos

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: National Hospital Organization Himeji Medical Center

location_facility: CIMOVA, Morals Vargas Centro de Investigación SC

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Ibcc - Instituto Brasileiro de Controle Do Cancer

location_facility: Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken München-Gauting

location_facility: Pacific Shores Medical Group in Long Beach

location_facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: National Hospital Organization Osaka Toneyama Medical Center

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka

location_facility: Ospedale San Giuseppe Moscati di Avellino

location_facility: Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente

location_facility: National Hospital Organization Yamaguchi Ube Medical Center

location_facility: Orszagos Koranyi Tbc es Pulmonologiai Intezet

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

location_facility: Cancer Hospital of Xinjiang Medical University

location_facility: Izmir Ekonomi Universitesi Medical Park Hastanesi

location_facility: Krasnoyarsk Regional Oncology Dispensary

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Phramongkutklao Hospital and Medical College

location_facility: Shengjing Hospital of China Medical University

location_facility: Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

location_facility: Ruijin Hospital, Shanghai Jiao Tong University

location_facility: Tambov Regional Oncology Clinical Dispansary

type: Other Identifier

title: A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

summary: The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).


title: A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)

summary: This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Italy
Germany
France
Japan
Norway
Belgium
Australia
Spain
Denmark
United States
United Kingdom

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Università Di Cagliari-Presidio Policlinico Monserrato

location_facility: University Medical Centre Hamburg-Eppendorf Centre of Oncology

location_facility: Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Royal Cornwall Hospital Truro Sunrise Centre

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: Texas Oncology - Wichita Falls Texoma Cancer Center

location_facility: The Royal Marsden Nhs Foundation Trust - Chelsea

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: I.R.C.C.S. Casa Sollievo Della Sofferenza

location_facility: Saitama Medical University International Medical Center

location_facility: The Royal Marsden Nhs Foundation Trust - Sutton

location_facility: Institut de Cancerologie de L Ouest - Site Paul Papin

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

location_facility: University Clinic Carl Gustav Carus Technical University Dresden

location_facility: Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Texas Oncology-Baylor Charles A. Sammons

location_facility: Center Hospital of the National Center For Global Health and Medicine


ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu

location_country:
United States
France
Japan
Russian Federation
Spain
Turkey
Germany
United Kingdom
Canada
Taiwan

acronym: REEF-IT

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: SBEI HPE Moscow State Medical and Dentistry University n.a. A. I. Evdokimov of the MoH of the RF

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: NHS Greater Glasgow and Clyde - Gartnavel General Hospital

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Ege University Medical of Faculty, Department of Gastroenterology

location_facility: Republic Clinical Infectious Hospital n.a. AF Agafonov

location_facility: Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1

location_facility: Clinical Infectious Diseases Hospital n. a. S.P. Botkin

location_facility: St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis

location_facility: Vancouver ID Research and Care Centre Society

title: A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate Efficacy, Pharmacokinetics, Safety, and Tolerability of Treatment With JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog With or Without JNJ-56136379 in Treatment-naive Patients With HBeAg Positive Chronic Hepatitis B Virus Infection

summary: The purpose of this study is to evaluate the efficacy of a treatment regimen of JNJ-73763989 + pegylated interferon alpha-2a (PegIFN-alpha-2a) + nucleos(t)ide analog (NA).


title: Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study

acronym: CARAVAGGIO

summary: Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study

status: Unknown status

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Giustozzi M, Connors JM, Ruperez Blanco AB, Szmit S, Falvo N, Cohen AT, Huisman M, Bauersachs R, Dentali F, Becattini C, Agnelli G. Clinical characteristics and outcomes of incidental venous thromboembolism in cancer patients: Insights from the Caravaggio study. J Thromb Haemost. 2021 Nov;19(11):2751-2759. doi: 10.1111/jth.15461. Epub 2021 Jul 29.

name: Internal Vascular and Emergency Medicine – Stroke Unit University of Perugia Perugia Italy

family: Giustozzi

full_name: Michela Giustozzi

given: Michela

sequence: first

name: Brigham and Womens’s Hospital Harvard Medical School Boston Massachusetts USA

family: Connors

full_name: Jean M. Connors

given: Jean M.

sequence: additional

name: Medical Oncology Service Complejo Hospitalario de Toledo (Castilla‐La Mancha) Toledo Spain

family: Ruperez Blanco

full_name: Ana Belen Ruperez Blanco

given: Ana Belen

name: Department of Pulmonary Circulation Thromboembolic Diseases and Cardiology Centre of Postgraduate Medical Education European Health Centre Otwock Poland

family: Szmit

full_name: Sebastian Szmit

given: Sebastian

name: Service d’Exploration Vasculaire et de Phlébologie Interventionnelle CHU Dijon Dijon France

family: Falvo

full_name: Nicolas Falvo

given: Nicolas

name: Guy’s and St Thomas’ NHS Foundation Trust, HospitalKing’s College London London UK

family: Cohen

full_name: Alexander T. Cohen

given: Alexander T.

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

family: Huisman

full_name: Menno Huisman

given: Menno

name: Department of Vascular MedicineKlinikum Darmstadt Darmstadt Germany

family: Bauersachs

full_name: Rupert Bauersachs

given: Rupert

name: Department of Medicine and Surgery Insubria UniversityASST Settelaghi Varese Italy

family: Dentali

full_name: Francesco Dentali

given: Francesco

family: Becattini

full_name: Cecilia Becattini

given: Cecilia

family: Agnelli

full_name: Giancarlo Agnelli

given: Giancarlo

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Thrombosis and Haemostasis

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Agnelli G, Becattini C, Meyer G, Muñoz A, Huisman MV, Connors JM, Cohen A, Bauersachs R, Brenner B, Torbicki A, Sueiro MR, Lambert C, Gussoni G, Campanini M, Fontanella A, Vescovo G, Verso M; Caravaggio Investigators. Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer. N Engl J Med. 2020 Apr 23;382(17):1599-1607. doi: 10.1056/NEJMoa1915103. Epub 2020 Mar 29.

name: From the Internal Vascular and Emergency Medicine–Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero–Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio–Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale–Università, Padua (G.V.) — all in Italy; Hôpital Européen...

family: Meyer

full_name: Guy Meyer

given: Guy

family: Muñoz

full_name: Andres Muñoz

given: Andres

full_name: Menno V. Huisman

given: Menno V.

full_name: Alexander Cohen

given: Alexander

location_country:
Italy
United States
Netherlands
Spain
France
Poland
Israel
Belgium
Portugal
Germany
United Kingdom

location_facility: Department of Internal Medicine - University of Perugia

location_facility: Centre Hospitalier Universitaire Lyon-Sud

location_facility: Ospedale Sacro Cuore-Don Calabria di Negrar-Verona.

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Ospedale San Giovanni Calibita Fatebenefratelli

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: University of Texas M.D. Anderson Cancer Center

location_facility: Ospedale Buon Consiglio Fatebenefratelli

location_facility: Istituto Nazionale Tumori - IRCCS Fondazione Pascale

location_facility: Hôpital des armées HIA Clermont Tonnerre

location_facility: Medical Centre for Postgraduate Education - ECZ-Otwock

location_facility: University of North Carolina at Chapel Hill

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Ospedale Sacro Cuore di Gesù Fatebenefratelli

location_facility: Staten Island University Hospital/Northwell Health

location_facility: CH de Vendée Centre Hospitalier Départemental

location_facility: Jacksonville Center for Clinical Research

location_facility: AO Ospedale di Circolo e Fondazione Macchi

location_facility: AO di Rilievo Nazione Antonio Cardarelli

location_facility: Centre Hospitalier Emile Roux Le Puy-en-Velay


title: A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer

summary: This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with refractory metastatic colorectal cancer (mCRC). 687 subjects will be randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.

ReferenceCitation: Dasari A, Sobrero A, Yao J, Yoshino T, Schelman W, Yang Z, Chien C, Kania M, Tabernero J, Eng C. FRESCO-2: a global Phase III study investigating the efficacy and safety of fruquintinib in metastatic colorectal cancer. Future Oncol. 2021 Aug;17(24):3151-3162. doi: 10.2217/fon-2021-0202. Epub 2021 May 17.

name: Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 426, Houston, TX 77030, USA

family: Dasari

full_name: Arvind Dasari

given: Arvind

name: Ospedale Policlinico San Martino – IRCCS, Largo R. Benzi n.10, Ospedale Policlinico San Martino, Padiglione ex Microbiologia, Piano Terra Levante, 16132, Genova, Italy

family: Sobrero

full_name: Alberto Sobrero

given: Alberto

family: Yao

full_name: James Yao

given: James

name: Department of Gastroenterology & Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 270-8577, Japan

family: Yoshino

full_name: Takayuki Yoshino

given: Takayuki

name: Clinical Development, Hutchison MediPharma International Incorporated, 25A Vreeland Road, Suite 304, Florham Park, NJ 07932, USA

family: Schelman

full_name: William Schelman

given: William

name: Biostatistics, Hutchison MediPharma International Incorporated, 25A Vreeland Road, Suite 304, Florham Park, NJ 07932, USA

family: Yang

full_name: Zhao Yang

given: Zhao

name: Clinical Pharmacology, Hutchison MediPharma International Incorporated, 25A Vreeland Road, Suite 304, Florham Park, NJ 07932, USA

family: Chien

full_name: Caly Chien

given: Caly

family: Kania

full_name: Marek Kania

given: Marek

name: Department of Medical Oncology, Vall d’Hebron Hospital Campus & Vall d’Hebron Institute of Oncology (VHIO), IOB-Quiron, UVic-UCC, Passeig Vall d’Hebron 119-129, Barcelona, 08035, Spain

family: Tabernero

full_name: Josep Tabernero

given: Josep

name: Division of Hematology & Oncology, Vanderbilt-Ingram Cancer Center, 2220 Pierce Ave, 777 PRB, Nashville, TN 37232, USA

family: Eng

full_name: Cathy Eng

given: Cathy

journal_name: Future Oncology

evidence: open (via page says license)

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

lead_sponsor: Hutchison Medipharma Limited

location_country:
Italy
Austria
Germany
France
Japan
Hungary
Australia
Belgium
Spain
Estonia
United States
United Kingdom

location_facility: City of Hope Comprehensive Cancer Center

location_facility: The George Washington University Medical Center

location_facility: Sihtasutus Pohja-Eesti Regionaalhaigla (PERH) (North Estonia Medical Centre)

location_facility: Szabolcs-Szatmar-Bereg megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: XCancer / New Mexico Oncology & Hematology Consultants

location_facility: Medical College of Wisconsin/ Froedtert Hospital

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Tartu University Hospital Clinic of Haematology and Oncology

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Institut de cancerologie Strasbourg-Europe

location_facility: Integrated Clinical Oncology Network Pty Ltd (Icon)

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital General Universitario Gregorio Maranon HGUGM

location_facility: Haematologisch-Onkologische Praxis Hamburg Eppendorf

location_facility: Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Megyei Onkologiai Kozpont

location_facility: Sarah Cannon Research Institute-S-Ft. Myers (FCS South)

location_facility: Universitaetsmedizin Mannheim- III. Medizinische Klinik

location_facility: Ospedale San Bortolo Azienda ULSS8 Berica - Distretto Est

location_facility: Hospital ClÃ-nico Universitario de Santiago-CHUS

location_facility: East Tallinn Central Hospital Centre of Oncology

location_facility: Sarah Cannon Research Institute-Pan-Tallahassee (FCS Panhandle)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Klinikai Onkologiai Osztaly

location_facility: Onze-Lieve-Vrouwziekenhuis OLV - Campus Aalst

location_facility: Zala Megyei Szent Rafael Korhaz, Onkologiai Osztaly, F epulet 3. em.

location_facility: Hospital Universitario Central de Asturias

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Ordensklinikum Linz Barmherzige Schwestern

location_facility: Institut fr Klinisch Onkologische ForschungKrankenhaus Nordwest GmbH

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Zentrum fÃ¼r HÃ¤matologie und Onkologie MVZ GmbH

location_facility: University of Louisville - James Brown Cancer Center

location_facility: Schwerpunktpraxis fuer Haematologie und Onkologie

location_facility: Del-Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet, Szent Laszlo Korhaz

location_facility: Centre Hospitalier Universitaire CHU de Rennes - Hopital de Pontchaillou

location_facility: CHU de Lige - Domaine Universitaire du Sart Tilman

location_facility: Clinica Oncologica, Ospedali Riuniti Umberto 1

location_facility: Sarah Cannon Research Institute-N-St Pete (FCS North)

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Asklepios Tumorzentrum Hamburg AK Altona

location_facility: Sarah Cannon Research-E-WPB (Florida Cancer Specialists-FCS East)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: Wiener Gesundheitsverbund - Klinik Ottakring

location_facility: Florida Cancer Specialists Tallahassee East


title: Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen

acronym: MASTER DAPT

summary:
The study compares two lengths of medication therapy (a shortened versus a prolonged dual antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the successfully treatment for coronary heart disease with a drug covered stent (metallic tube).

This comparison will be done in patients who, compared to the average patient, are more likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are within the current medical recommendations. The aim of this study is to help improve further standard antiplatelet duration guidelines.

status: Completed

study_completion_date_type: Actual

ReferenceType: background

ReferenceCitation: Authors/Task Force members, Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29.

journal_name: European Heart Journal

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

license: cc-by

license_normalized: cc-by

evidence: oa repository (semantic scholar lookup)

host_type: repository

license_normalized: no license

version: submittedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group . 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29.

ReferenceCitation: Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC, Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation 2016

ReferenceCitation: Smits PC, Frigoli E, Tijssen J, Jüni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iñiguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Heg D, Valgimigli M; MASTER DAPT Investigators. Abbreviated Antiplatelet Therapy in Patients at High Bleeding Risk With or Without Oral Anticoagulant Therapy After Coronary Stenting: An Open-Label, Randomized, Controlled Trial. Circulation. 2021 Oct 12;144(15):1196-1211. doi: 10.1161/CIRCULATIONAHA.121.056680. Epub 2021 Aug 29.

name: Department of Cardiology, Maasstad Hospital, Rotterdam, The Netherlands (P.C.S.).

family: Smits

full_name: Pieter C. Smits

given: Pieter C.

name: Clinical Trial Unit, University of Bern, Switzerland (E.F., D.H.).

family: Frigoli

full_name: Enrico Frigoli

given: Enrico

name: Department of Cardiology, Amsterdam University Medical Centers, The Netherlands (J.T.).

name: ECRI, Rotterdam, The Netherlands (J.T.).

family: Tijssen

full_name: Jan Tijssen

given: Jan

name: University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael’s Hospital, Canada (P.J.).

family: Jüni

full_name: Peter Jüni

given: Peter

name: Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Belgium (P.V.).

name: Faculty of Medicine and Life Sciences, Hasselt University, Belgium (P.V.).

family: Vranckx

full_name: Pascal Vranckx

given: Pascal

name: Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki).

family: Ozaki

full_name: Yukio Ozaki

given: Yukio

name: Cardiovascular European Research Center, Massy, France (M.-C.M.).

family: Morice

full_name: Marie-Claude Morice

given: Marie-Claude

name: Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud, Massy, France (B.C.).

family: Chevalier

full_name: Bernard Chevalier

given: Bernard

name: National University of Ireland, Galway (Y. Onuma).

family: Onuma

full_name: Yoshinobu Onuma

given: Yoshinobu

name: Department of Cardiology, Bern University Hospital, Switzerland (S.W.).

family: Windecker

full_name: Stephan Windecker

given: Stephan

name: Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands (P.A.L.T.).

family: Tonino

full_name: Pim A.L. Tonino

given: Pim A.L.

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

family: Roffi

full_name: Marco Roffi

given: Marco

name: First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.).

family: Lesiak

full_name: Maciej Lesiak

given: Maciej

name: Department of Cardiology, Angiology, Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.).

family: Mahfoud

full_name: Felix Mahfoud

given: Felix

name: Cardiovascular Center, OLV Hospital, Aalst, Belgium (J.B.).

family: Bartunek

full_name: Jozef Bartunek

given: Jozef

name: Brighton and Sussex University Hospitals NHS Trust, United Kingdom (D.H.-S.).

family: Hildick-Smith

full_name: David Hildick-Smith

given: David

name: Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan, Italy (A.C.).

family: Colombo

full_name: Antonio Colombo

given: Antonio

name: Department of Cardiology, Clinical Center of Serbia, and Faculty of Medicine, University of Belgrade (G.S.).

name: Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.).

name: Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia (C.S.).

name: Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Israel (R.K.).

name: Tan Tock Seng Hospital, Singapore (P.J.L.O.).

name: Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.).

name: Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center, Argentina (A.E.R.).

name: HerzZentrum, Hirslanden, Zürich, Switzerland (A.M.).

name: North-Estonia Medical Centre Foundation, Tallinn (P.L.).

name: Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano, Switzerland (M.V.).

name: on behalf of the MASTER DAPT Investigators

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Valgimigli M, Frigoli E, Heg D, Tijssen J, Jüni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stanković G, Iñiguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Donahue M, Leonardi S, Smits PC; MASTER DAPT Investigators. Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk. N Engl J Med. 2021 Oct 28;385(18):1643-1655. doi: 10.1056/NEJMoa2108749. Epub 2021 Aug 28.

name: From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) — all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J...

ReferenceCitation: Vlieger S, Danzi GB, Kauer F, Oemrawsingh RM, Stojkovic S, IJsselmuiden AJJ, Routledge H, Laanmets P, Roffi M, Fröbert O, Baello P, Wlodarczak A, Puentes A, Polad J, Hildick-Smith D. One-year performance of thin-strut cobalt chromium sirolimus-eluting stent versus thicker strut stainless steel biolimus-eluting coronary stent: a propensity-matched analysis of two international all-comers registries. Coron Artery Dis. 2021 Aug 1;32(5):391-396. doi: 10.1097/MCA.0000000000000958.

ReferenceCitation: Frigoli E, Smits P, Vranckx P, Ozaki Y, Tijssen J, Jüni P, Morice MC, Onuma Y, Windecker S, Frenk A, Spaulding C, Chevalier B, Barbato E, Tonino P, Hildick-Smith D, Roffi M, Kornowski R, Schultz C, Lesiak M, Iñiguez A, Colombo A, Alasnag M, Mullasari A, James S, Stankovic G, Ong PJL, Rodriguez AE, Mahfoud F, Bartunek J, Moschovitis A, Laanmets P, Leonardi S, Heg D, Sunnåker M, Valgimigli M. Design and rationale of the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen (MASTER DAPT) Study. Am Heart J. 2019 Mar;209:97-105. doi: 10.1016/j.ahj.2018.10.009. Epub 2018 Nov 22.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

location_country:
North Macedonia
Australia
Belgium
Denmark
Bahrain
India
France
Japan
Poland
Argentina
Slovenia
Korea, Republic of
Sweden
Saudi Arabia
Switzerland
Netherlands
Vietnam
Bulgaria
Singapore
Hungary
Germany
United Kingdom
Italy
Austria
Serbia
Czechia
Bangladesh
Israel
Spain
Estonia

location_facility: St.Marianna University School of Medicine

location_facility: Japan Red Cross Nagoya Daini Hospital (2nd)

location_facility: Japan Red Cross Nagoya Daiichi Hospital (1st)

location_facility: Second university of Naples Monaldi Hospital


ReferenceCitation: Dreyling M, Tam CS, Wang M, Smith SD, Ladetto M, Huang H, Novotny W, Co M, Romano A, Holmgren E, Huang J, Gouill SL. A Phase III study of zanubrutinib plus rituximab versus bendamustine plus rituximab in transplant-ineligible, untreated mantle cell lymphoma. Future Oncol. 2021 Jan;17(3):255-262. doi: 10.2217/fon-2020-0794. Epub 2020 Sep 28.

name: LMU University Hospital, Munich, 81377, Germany

family: Dreyling

full_name: Martin Dreyling

given: Martin

name: Peter MacCallum Cancer Centre, St Vincent’s Hospital, Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria 3000, Australia

family: Tam

full_name: Constantine S Tam

given: Constantine S

name: The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA

family: Wang

full_name: Michael Wang

given: Michael

name: University of Washington/Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA

family: Smith

full_name: Stephen D Smith

given: Stephen D

name: Divisione di Ematologia, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo, Alessandria, 15121, Italy

family: Ladetto

full_name: Marco Ladetto

name: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong Province, 510060, China

family: Huang

full_name: Huiqiang Huang

given: Huiqiang

name: BeiGene USA, Inc., San Mateo, CA 94403, USA

family: Novotny

full_name: William Novotny

given: William

family: Co

full_name: Melannie Co

given: Melannie

name: BeiGene Switzerland GmbH, 4051 Basel, Switzerland

family: Romano

full_name: Alfredo Romano

given: Alfredo

family: Holmgren

full_name: Eric Holmgren

given: Eric

full_name: Jane Huang

given: Jane

name: Centre Hospitalier Universitaire de Nantes, 44093 Nantes, France

family: Gouill

full_name: Steven Le Gouill

given: Steven Le

oa_colors: green other

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

repository_institution: University of Melbourne - Minerva Access

lead_sponsor: BeiGene

location_country:
Italy
Austria
Spain
Germany
France
Japan
Lithuania
Poland
Ireland
Australia
Belgium
New Zealand
China
United States
United Kingdom
Taiwan
Ukraine

location_facility: Centre Hospitalier Universitaire (CHU) de Liege - Site du Sart Tilman

location_facility: Uniwersytet Medyczny w Lodzi - Klinika Hematologii

location_facility: East Carolina University - Brody School of Medicine

location_facility: SALK- US- Universitatsklinik fuer Innere Medizin II, Kardiologie und internistische Intensivmedizin

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

location_facility: Sc Ematologia, Azienda Unita' Sanitaria Locale Irccs

location_facility: Uniwersytet Medyczny im. Piastów Śląskich we Wrocławiu

location_facility: Pratia Małopolskie Centrum Medyczne (MCM) Kraków

location_facility: University Hospital Limerick - Mid Western Cancer Centre

location_facility: Centre Hospitalier Intercommunal de Cornouaille - Hôpital Laënnec

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: Joe Arrington Cancer Research and Treatment Center (JACC)

location_facility: Harbor-UCLA Medical Center- The Liu Center for the Study and Treatment of Pulmonary Hypertension

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli

location_facility: Institut Catalia d'oncologia- l'Hospitalet

location_facility: Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Centre Hospitalier Universitaire Nantes - Hotel Dieu

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Hospital Regional Universitario de Málaga - Hospital General

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Centro Ricerche Cliniche di Verona (CRC)

location_facility: MUW - AKH - Universitaetsklinik fuer Innere Medizin II

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: University Hospital, Kyoto Prefectural Univ of Medicine

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Szpital Uniwersytecki Nr. 2 im Dr. Jana Biziela w Bydgoszczy

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: Silesian Healthy Blood Clinic Grosicki, Grosicka Sp. j.

location_facility: Wojewodzki Szpital Specjalistyczny w Legnicy

location_facility: Tri-Service General Hospital - Neihu Branch - Hematology

location_facility: Specjalistyczny Szpital im. dr Alfreda Sokolowskiego

location_facility: Rush University Medical Center - Rush University Gastroenterologists

location_facility: Copernicus Podmiot Leczniczy Wojewódzkiego Centrum Onkologii

title: A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) Plus Rituximab Versus Bendamustine Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

summary: This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.


title: Computerized Registry of Patients With Venous Thromboembolism (RIETE)

acronym: RIETE

summary:
The Computerized Registry of Patients with Venous Thromboembolism (RIETE) is a multidisciplinary Project initiated in march 2001 and consisting in obtaining an extensive data registry of consecutive patients with venous thromboembolism.

The main objective is to provide information on the Internet to help physicians to improve their knowledge on the natural history of thromboembolic disease, particularly in those subgroups of patients who are usually not recruited in randomized clinical trials (pregnant women, elderly patients, disseminated cancer, severe renal insufficiency, patients with contraindications to anticoagulation therapy, extreme body weight, etc), with the purpose of decreasing mortality, frequency of thromboembolic recurrences as well as bleeding complications and arterial events.

As an additional objective RIETE is also aimed to create predictive scores that help physicians to better identify patients with high risk of presenting some of these complications.

The primary parameters recorded by the registry comprise details of each patient's clinical status, including any coexisting or underlying conditions, and the type, dose, duration and outcome (during the first 3 months of therapy) of antithrombotic treatment. Study endpoints are clinically recognized (and objectively confirmed) recurrences of VTE, major and minor bleeding complications, and death.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Expósito-Ruiz M, Arcelus JI, Caprini JA, López-Espada C, Bura-Riviere A, Amado C, Loring M, Mastroiacovo D, Monreal M; RIETE Investigators. Timing and characteristics of venous thromboembolism after noncancer surgery. J Vasc Surg Venous Lymphat Disord. 2021 Jul;9(4):859-867.e2. doi: 10.1016/j.jvsv.2020.11.017. Epub 2020 Nov 26.

family: Expósito-Ruiz

full_name: Manuela Expósito-Ruiz

given: Manuela

family: Arcelus

full_name: Juan Ignacio Arcelus

given: Juan Ignacio

family: Caprini

full_name: Joseph A. Caprini

given: Joseph A.

family: López-Espada

full_name: Cristina López-Espada

given: Cristina

family: Bura-Riviere

full_name: Alessandra Bura-Riviere

given: Alessandra

family: Amado

full_name: Cristina Amado

family: Loring

full_name: Mónica Loring

given: Mónica

family: Mastroiacovo

full_name: Daniela Mastroiacovo

given: Daniela

family: Monreal

full_name: Manuel Monreal

given: Manuel

family: Prandoni

full_name: Paolo Prandoni

given: Paolo

family: Brenner

full_name: Benjamin Brenner

given: Benjamin

family: Farge-Bancel

full_name: Dominique Farge-Bancel

given: Dominique

family: Barba

full_name: Raquel Barba

given: Raquel

family: Di Micco

full_name: Pierpaolo Di Micco

given: Pierpaolo

family: Bertoletti

full_name: Laurent Bertoletti

given: Laurent

family: Schellong

full_name: Sebastian Schellong

given: Sebastian

family: Tzoran

full_name: Inna Tzoran

given: Inna

family: Reis

full_name: Abilio Reis

given: Abilio

family: Bosevski

full_name: Marijan Bosevski

given: Marijan

family: Bounameaux

full_name: Henri Bounameaux

given: Henri

family: Malý

full_name: Radovan Malý

given: Radovan

family: Verhamme

full_name: Peter Verhamme

given: Peter

journal_name: Journal of Vascular Surgery: Venous and Lymphatic Disorders

ReferenceCitation: Camporese G, Simioni P, Di Micco P, Fernández-Capitán C, Rivas A, Font C, Sahuquillo JC, Villares P, Prandoni P, Monreal M; RIETE Investigators. Edoxaban for the Long-Term Therapy of Venous Thromboembolism: Should the Criteria for Dose Reduction be Revised? Clin Transl Sci. 2021 Jan;14(1):335-342. doi: 10.1111/cts.12876. Epub 2020 Oct 10.

name: Department of Cardiac, Thoracic, and Vascular Sciences Unit of Angiology University Hospital of Padua  Padua Italy

name: Department of Internal Medicine General Medicine Unit Thrombotic and Haemorrhagic Disorders Unit University Hospital of Padua  Padua Italy

name: Department of Internal Medicine and Emergency Room Ospedale Buon Consiglio Fatebenefratelli  Naples Italy

name: Department of Internal Medicine Hospital Universitario La Paz  Madrid Spain

name: Department of Pneumonology Hospital Universitario Araba  Álava Spain

name: Department of Medical Oncology Hospital Clínic  Barcelona Spain

name: Department of Internal Medicine Hospital Municipal de Badalona  Barcelona Spain

name: Department of Internal Medicine Hospital de Madrid Norte Sanchinarro  Madrid Spain

name: Department of Cardiovascular Sciences Vascular Medicine Unit University of Padua  Padua Italy

name: Department of Internal Medicine Hospital Germans Trias i Pujol Universidad Autónoma de Barcelona  Barcelona Spain

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

title: Edoxaban for the Long‐Term Therapy of Venous Thromboembolism: Should the Criteria for Dose Reduction be Revised?

ReferenceCitation: Jiménez D, Bikdeli B, Quezada A, Muriel A, Lobo JL, de Miguel-Diez J, Jara-Palomares L, Ruiz-Artacho P, Yusen RD, Monreal M; RIETE investigators. Hospital volume and outcomes for acute pulmonary embolism: multinational population based cohort study. BMJ. 2019 Jul 29;366:l4416. doi: 10.1136/bmj.l4416.

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

repository_institution: Washington University School of Medicine - Digital Commons@Becker

repository_institution: Spanish National Research Council (CSIC) - DIGITAL.CSIC

repositories:
DIGITAL.CSIC (Spain)
PubMed Central
digitalcommons.wustl.edu

ReferenceCitation: Mellado M, Trujillo-Santos J, Bikdeli B, Jiménez D, Núñez MJ, Ellis M, Marchena PJ, Vela JR, Clara A, Moustafa F, Monreal M; RIETE Investigators. Vena cava filters in patients presenting with major bleeding during anticoagulation for venous thromboembolism. Intern Emerg Med. 2019 Oct;14(7):1101-1112. doi: 10.1007/s11739-019-02077-5. Epub 2019 May 3. Erratum in: Intern Emerg Med. 2019 Jun 20;:. Intern Emerg Med. 2020 Oct;15(7):1357.

location_country:
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Greece
Belgium
Ecuador
France
Japan
Argentina
Iran, Islamic Republic of
Switzerland
Vietnam
Ireland
China
Portugal
Germany
United States
Italy
Austria
Brazil
Honduras
Czechia
Israel
Egypt
Spain
Latvia

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location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Hospital Central de la Defensa Gómez Ulla

location_facility: Japanese Red Cross Wakayama Medical Center

location_facility: Municipal Hospital of Dresden Friedrichstadt

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Complexo Hospitalario Universitario de Ourense

location_facility: Consorcio Hospitalario Provincial de Castellón

location_facility: Hospital Universitari de Girona Dr. Josep Trueta

location_facility: Botucatu Medical School - São Paulo State University (UNESP)

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: Centro Hospitalar de Entre o Douro e Vouga

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Hospital General Universitario de Albacete

location_facility: Hospital Universitario General de Cataluña

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Ospedale Buon Consiglio Fatebenefratelli

location_facility: Ospedale SS. Giovanni e Paolo di Venezia

location_facility: Bach Mai Hospital Vietnam Heart Institue

location_facility: Evanston NorthShore University HealthSystem

location_facility: Hospital Universitario Clínico San Carlos

location_facility: PHI University Clinic of Pulmology and Allergy Skopje

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Complejo Hospitalario Insular-Materno Infantil

location_facility: Hospital d'Olot i Comarcal de la Garrotxa

location_facility: Complejo Hospitalario Universitario de Ferrol

location_facility: Hospital Clínico Universitario de Santiago

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Abu-Ali- Sina Organ Transplant Center (OCT)

location_facility: Hospital Pedro Hispano - Unidade Local de Saúde de Matosinhos

location_facility: Hospital Universitario de Gran Canaria Dr. Negrín

location_facility: Althaia, Xarxa Assistencial Universitària de Manresa

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Hospital Universitario Clínic de Barcelona

location_facility: Ain Shams University Specialized Hospital

location_facility: Hospital General Universitario Santa Lucía

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital General Universitari de Castelló

location_facility: Hematology Institute of ZIV Medical Center

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Azienda Ospedaliera Universitaria di Parma

location_facility: Hospital Regional Universitario de Málaga

location_facility: Peking University Cancer Hospital and Institute

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Azienda U.S.L. Di Ravenna - O.C. Di Faenza

location_facility: Hospital General Universitario de Ciudad Real


status: Active, not recruiting

lead_sponsor: Bayer

location_country:
Finland
Belgium
Australia
Russian Federation
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Sweden
Netherlands
Bulgaria
China
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain

acronym: ARASENS

title: A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer

summary: The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.


title: A Phase 2 Proof-of-concept Study to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa

acronym: EVADE

summary: Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.

primary_purpose: Prevention

lead_sponsor: MedImmune LLC

location_country:
Austria
Spain
Croatia
Czechia
France
Greece
Israel
Hungary
Belgium
Ireland
Portugal
Turkey
United States
United Kingdom

intervention_type: Other

status_simplified: Completed


title: A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis LUCENT 3

summary: This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC).

ipd_sharing_description:
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Malaysia
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
India
France
Japan
Lithuania
Poland
Slovakia
Argentina
Moldova, Republic of
Canada
Korea, Republic of
Switzerland
Netherlands
Hungary
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Serbia
Mexico
Czechia
Israel
Georgia
Spain
Turkey
Latvia

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

location_facility: Ishida Clinic of IBD and Gastroenterology

location_facility: Communal Enterprise "Odesa Regional Clinical Hospital"

location_facility: Hospital Universitari de Girona Dr. Josep Trueta

location_facility: Tokushukai Sapporo Higashi Tokushukai Hospital

location_facility: University of Oklahoma Health Sciences Center

location_facility: Gastroenterologische Praxis Dres Behrens, Steudel, Fechner

location_facility: CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Vilniaus Universiteto Ligonines Santariskiu Klinikos

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

location_facility: GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health

location_facility: Gastroenterology Research of San Antonio

location_facility: Communal City Clinical Emergency Hospital, Danylo Galytskyy Lviv National Medical University

location_facility: Hamburgisches Forschungsinstitut fuer Chronisch Entzuendliche Darmerkrankungen

location_facility: Pauls Stradins Clinical Univeristy Hospital

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: KM Management spol. s r.o. Gastroenterologicke a hepatologicke centrum

location_facility: University of North Carolina Center for Inflammatory Bowel Disease

location_facility: Renji Hospital Affliated to Shanghai Jiaotong University

location_facility: Communal Non-Commercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

location_facility: Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Intezet

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Riga Eastern Clinical University Hospital

location_facility: Care Access Research LLC - Salt Lake City

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej

location_facility: Research Associates of South Florida, LLC

location_facility: Centro Para el Desarrollo de la Medicina y de Asistencia Med

location_facility: Vinnytsia M.I. Pyrogov NMU Ch of internal medicine #1

location_facility: Multidisciplinary Medical Clinic "Anthurium"

location_facility: The Sixth Affiliated Hospital, Sun Yat-Sen University

location_facility: Karelia Republican Hospital V.A. Baranova

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: Showa University Northern Yokohama Hospital

location_facility: Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC Ukrainian Railway Sta

location_facility: Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech

location_facility: SE Belgyogyaszati és Hematologiai Klinika

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Galilee Medical Center Department of Internal Medicine A

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: The Gordon and Leslie Diamond Health Care Centre

location_facility: Wojewodzki Specjalistyczny Szpital w Olsztynie

location_facility: Apollo Research and Innovations, Apollo Hospitals International Ltd

location_facility: International Institute of Clinical Trials LLC

location_facility: Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz IV. Belgyogyaszat

location_facility: Praxis Balsiger, Seibold & Partner und Crohn-Colitis-Zentrum

location_facility: The Second Affiliated Hospital of Zhejiang University School of Med

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: First Affiliated Hosp of College of Med, Zhejiang University

location_facility: Centre Hospitalier de Wallonie Picarde - Site Notre Dame

location_facility: Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii

location_facility: CHU Amiens Picardie Site Sud - Service d'Hepato-gastro-entérologie

location_facility: Pusat Perubatan University Kebangsaan Malaysia

location_facility: Communal Institution "Poltava Reg.Cl.H. n.a.M.V.Sklifosovskogo"

location_facility: Centre hospitalier universitaire de Haut Leveque

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Tokyo Medical And Dental University Medical Hospital

location_facility: Centrum Zdrowia Matki, Dziecka i Młodzieży (CZMDM) Przychodnie

location_facility: Clinical Center Kragujevac Gastroenterohepatology Clinic

location_facility: The Catholic University of Daejeon St. Mary's Hospital

location_facility: The Second Affiliated Hospital of Wenzhou Medical College

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas

location_facility: Gastroenterology Associates of Western Michigan, P.L.C.

location_facility: Poona Medical Foundation. Ruby Hall Clinic

location_facility: Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital

location_facility: Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"

location_facility: Azienda Ospedlaliero-Univeristaria Pisana - Ospedale di Cisanello - Gastroenterologia

location_facility: Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod

location_facility: The First People's Hospital of Yunnan Province

location_facility: Digestive Health Specialists of the Southeast

location_facility: Ivano-Frankivsk State Medical University

location_facility: Hospital Universitario Central de Asturias

location_facility: Gastroenterology Associates of Pensacola, PA

location_facility: Academician I.P. Pavlov First St-Petersburg State Medical University

location_facility: LLC Scientific Research Centre EKO-Bezopasnost

location_facility: Kocaeli University Medical Faculty Hospital

location_facility: Shinseikai Sai Gastroenterology, proctology

location_facility: Toho University School of Medicine, Sakura Hospital

location_facility: AKH - Gastroenterologie und Hepatologie - Interne Medizin III

location_facility: NZOZ ALL-MEDICUS, Zaklad Gastroenterologii

location_facility: SHI of Yaroslavl Region Clinical Hospital #8

location_facility: Nizhegorodskiy Regional Clinical Hospital N.A.Semashko

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: M S Ramaiah Medical College and Hospitals

location_facility: Centrum Medyczne Lux Med Poradnia Gastroenterologii

location_facility: Endomed, s.r.o.- Gastroenterologicka ambulancia

location_facility: Center Hospital of the National Center for Global Health and Medicine


ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Italy
United States
Brazil
Chile
Peru
Mexico
Spain
Germany
France
Japan
Poland
Israel
Belgium
Australia
China
Canada
United Kingdom
Korea, Republic of
Taiwan
Colombia

acronym: Spotlight

location_facility: University of Maryland Medical Center(UMMC)Transplant Center

location_facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer

location_facility: Cancer Treatment Centers of America, Atlanta

location_facility: University of California - San Francisco

location_facility: Cancer Treatment Centers of America, Philadelphia

location_facility: The University of Arizona Medical Center

location_facility: Precision Cancer Research -Dayton Physicians Network

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: The Ohio State University Medical Center

location_facility: Gene Upshaw Memorial Tahoe Forest Cancer Center - Pharmacy

location_facility: MultiCare Regional Cancer Center - Gig Harbor

location_facility: University of Oklahoma Health Science Center

location_facility: Cancer Treatment Centers of America, Phoenix

location_facility: Inova Dwight and Martha Schar Cancer Institute

location_facility: Rhode Island Hospital-Lifespan Cancer Institute

location_facility: The Angeles Clinic and Research Institute

type: Registry Identifier

title: A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

summary:
A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Why is this study being done?

SPOTLIGHT is a new clinical study for adult patients who have any of:

advanced unresectable gastric or GEJ cancer
metastatic gastric or GEJ cancer These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells.

For patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death.

Patients will be assigned to one of two groups by chance and given either:

zolbetuximab with mFOLFOX6; or
a placebo with mFOLFOX6 A placebo is a treatment that looks like the experimental medicine, but contains no medicine.

The goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.


ReferenceCitation: Pitt B, Filippatos G, Agarwal R, Anker SD, Bakris GL, Rossing P, Joseph A, Kolkhof P, Nowack C, Schloemer P, Ruilope LM; FIGARO-DKD Investigators. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. N Engl J Med. 2021 Aug 28. doi: 10.1056/NEJMoa2110956. [Epub ahead of print]

name: From the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité...

family: Pitt

full_name: Bertram Pitt

given: Bertram

family: Filippatos

full_name: Gerasimos Filippatos

given: Gerasimos

family: Agarwal

full_name: Rajiv Agarwal

given: Rajiv

family: Anker

full_name: Stefan D. Anker

given: Stefan D.

family: Bakris

full_name: George L. Bakris

given: George L.

family: Rossing

full_name: Peter Rossing

family: Joseph

full_name: Amer Joseph

given: Amer

family: Kolkhof

full_name: Peter Kolkhof

family: Nowack

full_name: Christina Nowack

given: Christina

family: Schloemer

full_name: Patrick Schloemer

given: Patrick

family: Ruilope

full_name: Luis M. Ruilope

given: Luis M.

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: Erraez S, López-Mesa M, Gómez-Fernández P. [Mineralcorticoid receptor blockers in chronic kidney disease]. Nefrologia (Engl Ed). 2021 May-Jun;41(3):258-275. doi: 10.1016/j.nefro.2020.10.001. Epub 2020 Dec 24. Review. English, Spanish.

apc_source: doaj

family: Erraez

full_name: Sara Erraez

given: Sara

family: López-Mesa

full_name: Manuel López-Mesa

family: Gómez-Fernández

full_name: Pablo Gómez-Fernández

given: Pablo

currency_apc_doaj: EUR

journal_name: Nefrología

evidence: oa journal (via doaj)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Bloqueantes del receptor mineralcorticoide en la enfermedad renal crónica

ReferenceCitation: Agarwal R, Anker SD, Bakris G, Filippatos G, Pitt B, Rossing P, Ruilope L, Gebel M, Kolkhof P, Nowack C, Joseph A; FIDELIO-DKD and FIGARO-DKD Investigators. Investigating new treatment opportunities for patients with chronic kidney disease in type 2 diabetes: the role of finerenone. Nephrol Dial Transplant. 2020 Dec 6. pii: gfaa294. doi: 10.1093/ndt/gfaa294. [Epub ahead of print]

name: Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis, IN, USA

name: Department of Cardiology (CVK) and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany

full_name: Stefan D Anker

given: Stefan D

name: Department of Medicine, University of Chicago Medicine, Chicago, IL, USA

full_name: George Bakris

given: George

name: National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens, Greece

name: Department of Medicine, University of Michigan School of Medicine, Ann Arbor, MI, USA

name: Steno Diabetes Center Copenhagen, Gentofte, Denmark

name: Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark

name: Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain

name: IBER-CV, Hospital Universitario, 12 de Octubre, Madrid, Spain

name: Faculty of Sport Sciences, European University of Madrid, Madrid, Spain

name: Research and Development, Statistics and Data Insights, Bayer AG, Berlin, Germany

name: Research and Development, Preclinical Research Cardiovascular, Bayer AG, Wuppertal, Germany

name: Research and Development, Clinical Development Operations, Bayer AG, Wuppertal, Germany

name: Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany

name: on behalf of the FIDELIO-DKD and FIGARO-DKD Investigators

repository_institution: Universidad Europea - ABACUS. Repositorio de Producción Científica

ReferenceCitation: Ito S, Kashihara N, Shikata K, Nangaku M, Wada T, Okuda Y, Sawanobori T. Esaxerenone (CS-3150) in Patients with Type 2 Diabetes and Microalbuminuria (ESAX-DN): Phase 3 Randomized Controlled Clinical Trial. Clin J Am Soc Nephrol. 2020 Dec 7;15(12):1715-1727. doi: 10.2215/CJN.06870520. Epub 2020 Nov 25.

journal_name: Clinical Journal of the American Society of Nephrology

ReferenceCitation: Ruilope LM, Agarwal R, Anker SD, Bakris GL, Filippatos G, Nowack C, Kolkhof P, Joseph A, Mentenich N, Pitt B; FIGARO-DKD study investigators. Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial. Am J Nephrol. 2019;50(5):345-356. doi: 10.1159/000503712. Epub 2019 Oct 30.

repository_institution: Ghent University - Ghent University Academic Bibliography

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, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's 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:
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Lithuania
Poland
Slovakia
Norway
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Philippines
Switzerland
Vietnam
Bulgaria
Singapore
Hungary
Ireland
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Turkey

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.

summary: The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.


title: A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, PK, Biological and Clinical Activity of MSB0011359C in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

summary: The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means the study drug has not previously been given to humans or has only been given to a limited number of people, although it has been extensively studied in animals. Based on this information, it is hoped to find out which dose could be best for the treatment of patients. There are two parts of this research study: a dose-escalation part and an expansion part. Dose escalation means that the first people taking part in the study will receive low doses of the study drug, and as more people take part, the additional participants will receive a higher dose. This is done to find the safest dose for the study drug. Expansion means that after the dose-escalation part of the study has looked at the safety and effectiveness of different doses, many more people will be invited to take part in the study and will receive the study drug at the safest dose. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body.

ReferenceCitation: Tan B, Khattak A, Felip E, Kelly K, Rich P, Wang D, Helwig C, Dussault I, Ojalvo LS, Isambert N. Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in Patients with Esophageal Adenocarcinoma: Results from a Phase 1 Cohort. Target Oncol. 2021 Jul;16(4):435-446. doi: 10.1007/s11523-021-00809-2. Epub 2021 May 19.

family: Tan

full_name: Benjamin Tan

given: Benjamin

family: Khattak

full_name: Adnan Khattak

given: Adnan

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

family: Kelly

full_name: Karen Kelly

given: Karen

family: Rich

full_name: Patricia Rich

given: Patricia

family: Wang

full_name: Ding Wang

given: Ding

family: Helwig

full_name: Christoph Helwig

given: Christoph

family: Dussault

full_name: Isabelle Dussault

given: Isabelle

family: Ojalvo

full_name: Laureen S. Ojalvo

given: Laureen S.

family: Isambert

full_name: Nicolas Isambert

given: Nicolas

journal_name: Targeted Oncology

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Strauss J, Gatti-Mays ME, Cho BC, Hill A, Salas S, McClay E, Redman JM, Sater HA, Donahue RN, Jochems C, Lamping E, Burmeister A, Marté JL, Cordes LM, Bilusic M, Karzai F, Ojalvo LS, Jehl G, Rolfe PA, Hinrichs CS, Madan RA, Schlom J, Gulley JL. Bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in patients with human papillomavirus-associated malignancies. J Immunother Cancer. 2020 Dec;8(2). pii: e001395. doi: 10.1136/jitc-2020-001395.

family: Strauss

full_name: Julius Strauss

given: Julius

family: Gatti-Mays

full_name: Margaret E Gatti-Mays

given: Margaret E

family: Cho

full_name: Byoung Chul Cho

given: Byoung Chul

family: Hill

full_name: Andrew Hill

given: Andrew

family: Salas

full_name: Sébastien Salas

given: Sébastien

family: McClay

full_name: Edward McClay

given: Edward

family: Redman

full_name: Jason M Redman

given: Jason M

family: Sater

full_name: Houssein A Sater

repository_institution: Yonsei University Medical Library - YUHSpace

ReferenceCitation: Cho BC, Daste A, Ravaud A, Salas S, Isambert N, McClay E, Awada A, Borel C, Ojalvo LS, Helwig C, Rolfe PA, Gulley JL, Penel N. Bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in advanced squamous cell carcinoma of the head and neck: results from a phase I cohort. J Immunother Cancer. 2020 Jul;8(2). pii: e000664. doi: 10.1136/jitc-2020-000664. Erratum in: J Immunother Cancer. 2020 Oct;8(2):.

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

ReferenceCitation: Wilkins JJ, Vugmeyster Y, Dussault I, Girard P, Khandelwal A. Population Pharmacokinetic Analysis of Bintrafusp Alfa in Different Cancer Types. Adv Ther. 2019 Sep;36(9):2414-2433. doi: 10.1007/s12325-019-01018-0. Epub 2019 Jul 5.

ReferenceCitation: Strauss J, Heery CR, Schlom J, Madan RA, Cao L, Kang Z, Lamping E, Marté JL, Donahue RN, Grenga I, Cordes L, Christensen O, Mahnke L, Helwig C, Gulley JL. Phase I Trial of M7824 (MSB0011359C), a Bifunctional Fusion Protein Targeting PD-L1 and TGFβ, in Advanced Solid Tumors. Clin Cancer Res. 2018 Mar 15;24(6):1287-1295. doi: 10.1158/1078-0432.CCR-17-2653. Epub 2018 Jan 3.

publisher: American Association for Cancer Research (AACR)

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Italy
United States
Germany
France
Japan
Belgium
Australia
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Hematology - Oncology Associates of Treasure Coast

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Gallipoli Medical Research Foundation Ltd

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: University of North Carolina at Chapel Hill

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Penn State University Milton S. Hershey Medical Center

location_facility: Seoul National University Bundang Hospital

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Peter MacCallum Cancer Centre-East Melbourne

location_facility: South Texas Accelerated Research Therapeutics, LLC

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Eastern Connecticut Hematology/Oncology Assoc.

location_facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo

location_facility: University of California Davis Health System

location_facility: Greenville Hospital System University Medical Center (ITOR)

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics


ReferenceCitation: Hess CN, Patel MR, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Fanelli F, Yeh RW, Secemsky EA, Beckman JA, Mauri L, Govsyeyev N, Capell WH, Brackin T, Berkowitz SD, Muehlhofer E, Haskell LP, Hiatt WR, Bonaca MP. Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD. J Am Coll Cardiol. 2021 Nov 2;78(18):1768-1778. doi: 10.1016/j.jacc.2021.08.052.

family: Hess

full_name: Connie N. Hess

given: Connie N.

family: Patel

full_name: Manesh R. Patel

given: Manesh R.

family: Bauersachs

full_name: Rupert M. Bauersachs

given: Rupert M.

family: Anand

full_name: Sonia S. Anand

given: Sonia S.

family: Debus

full_name: E. Sebastian Debus

given: E. Sebastian

family: Nehler

full_name: Mark R. Nehler

given: Mark R.

family: Fanelli

full_name: Fabrizio Fanelli

given: Fabrizio

family: Yeh

full_name: Robert W. Yeh

given: Robert W.

family: Secemsky

full_name: Eric A. Secemsky

given: Eric A.

family: Beckman

full_name: Joshua A. Beckman

given: Joshua A.

family: Mauri

full_name: Laura Mauri

given: Laura

family: Govsyeyev

full_name: Nicholas Govsyeyev

given: Nicholas

family: Capell

full_name: Warren H. Capell

given: Warren H.

family: Brackin

full_name: Taylor Brackin

given: Taylor

family: Berkowitz

full_name: Scott D. Berkowitz

given: Scott D.

family: Muehlhofer

full_name: Eva Muehlhofer

given: Eva

family: Haskell

full_name: Lloyd P. Haskell

given: Lloyd P.

family: Hiatt

full_name: William R. Hiatt

given: William R.

family: Bonaca

full_name: Marc P. Bonaca

given: Marc P.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Debus ES, Nehler MR, Govsyeyev N, Bauersachs RM, Anand SS, Patel MR, Fanelli F, Capell WH, Brackin T, Hinterreiter F, Krievins D, Nault P, Piffaretti G, Svetlikov A, Jaeger N, Hess CN, Sillesen HH, Conte M, Mills J, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR, Bonaca MP. Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial. Circulation. 2021 Oct 5;144(14):1104-1116. doi: 10.1161/CIRCULATIONAHA.121.054835. Epub 2021 Aug 12.

name: Department of Vascular Medicine, Vascular Surgery–Angiology–Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg, Germany (E.S.D.).

name: CPC Clinical Research, Aurora, CO (M.R.N., N.G., W.H.C., T.B., N.J., C.N.H., W.R.H., M.P.B.).

name: Division of Vascular Surgery, Department of Surgery (M.R.N., N.G.), Department of Medicine, University of Colorado School of Medicine, Aurora.

name: Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Germany (R.M.B.).

name: Population Health Research Institute, Hamilton Health Sciences and McMaster University, Ontario, Canada (S.S.A.).

name: Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.).

name: Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Italy (F.F.).

name: Division of Endocrinology (W.H.C.), Department of Medicine, University of Colorado School of Medicine, Aurora.

name: Department for Vascular Surgery Krankenhaus Barmherzige Brüder Linz, Austria (F.H.).

name: Pauls Stradins University Hospital, University of Latvia, Riga (D.K.).

name: Vascular and Endovascular Surgery, McGill University Montreal, Quebec, Canada (P.N.).

name: Vascular Surgery, Department of Medicine and Surgery, University of Insubria School of Medicine, Varese, Italy (G.P.).

name: The I.I. Mechnikov North-Western State Medical University, Department of Cardiovascular Surgery, St. Petersburg, Russia (A.S.).

name: Division of Cardiology (C.N.H., W.R.H., M.P.B.), Department of Medicine, University of Colorado School of Medicine, Aurora.

name: Department of Vascular Surgery, Rigshospitalet, Institute of Clinical Medicine, University of Copenhagen, Denmark (H.H.S.).

name: Division of Vascular and Endovascular Surgery, University of California, San Francisco (M.C.).

name: Division of Vascular Surgery and Endovascular Therapy, Baylor College of Medicine, Houston, TX (J.M.).

name: Janssen Research and Development, Raritan, NJ (L.P.H.).

name: Thrombosis Group Head, Clinical Development, Bayer US, Whippany, NJ (S.D.B.).

ReferenceCitation: Bauersachs RM, Szarek M, Brodmann M, Gudz I, Debus ES, Nehler MR, Anand SS, Patel MR, Hess CN, Capell WH, Rogers K, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR, Bonaca MP; VOYAGER PAD Committees and Investigators. Total Ischemic Event Reduction With Rivaroxaban After Peripheral Arterial Revascularization in the VOYAGER PAD Trial. J Am Coll Cardiol. 2021 Jul 27;78(4):317-326. doi: 10.1016/j.jacc.2021.05.003. Epub 2021 May 16.

ReferenceCitation: Hiatt WR, Bonaca MP, Patel MR, Nehler MR, Debus ES, Anand SS, Capell WH, Brackin T, Jaeger N, Hess CN, Pap AF, Berkowitz SD, Muehlhofer E, Haskell L, Brasil D, Madaric J, Sillesen H, Szalay D, Bauersachs R. Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety. Circulation. 2020 Dec 8;142(23):2219-2230. doi: 10.1161/CIRCULATIONAHA.120.050465. Epub 2020 Nov 3.

name: CPC Clinical Research, Aurora, CO (W.R.H., M.P.B., M.R.N., W.H.C., T.B., N.J., C.N.H.).

name: University of Colorado School of Medicine, Division of Cardiology, Anschutz Medical Campus, Aurora (W.R.H., M.P.B., C.N.H.).

name: Duke Clinical Research Institute, Division of Cardiology, Duke University Medical Center, Durham, NC (M.R.P.).

name: Department of Surgery (M.R.N.), University of Colorado School of Medicine, Aurora.

name: Population Health Research Institute, Hamilton Health Sciences, McMaster University, ON, Canada (S.S.A.).

name: Department of Medicine, Division of Endocrinology, University of Colorado Anschutz Medical Campus, Aurora (W.H.C.).

name: Bayer AG, Research & Development, Wuppertal, Germany (A.F.P., E.M.).

name: Janssen Research and Development, Raritan, NJ (L.H.).

name: FELUMA–Faculdade de Ciencias Medicas de Minas Gerais School of Medicine, Belo Horizonte, Brazil (D.B.).

name: Department of Angiology, Comenius University and National Cardiovascular Institute, Bratislava, Slovakia (J.M.).

name: Department of Vascular Surgery, Rigshospitalet, Institute of Clinical Medicine, University of Copenhagen, Denmark(H.S.).

name: McMaster University, Hamilton, ON, Canada (D.S.).

name: Department of Vascular Medicine, Klinikum Darmstadt GmbH, Germany (R.B.).

ReferenceCitation: Bonaca MP, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Patel MR, Fanelli F, Capell WH, Diao L, Jaeger N, Hess CN, Pap AF, Kittelson JM, Gudz I, Mátyás L, Krievins DK, Diaz R, Brodmann M, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR. Rivaroxaban in Peripheral Artery Disease after Revascularization. N Engl J Med. 2020 May 21;382(21):1994-2004. doi: 10.1056/NEJMoa2000052. Epub 2020 Mar 28.

name: From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) — all in Aurora; the Department...

ReferenceCitation: Capell WH, Bonaca MP, Nehler MR, Chen E, Kittelson JM, Anand SS, Berkowitz SD, Debus ES, Fanelli F, Haskell L, Patel MR, Bauersachs R, Hiatt WR. Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD). Am Heart J. 2018 May;199:83-91. doi: 10.1016/j.ahj.2018.01.011. Epub 2018 Feb 3.

location_country:
Finland
Romania
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Lithuania
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Czechia
Spain
Estonia
Latvia

title: An International, Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Thrombotic Vascular Events in Patients With Symptomatic Peripheral Artery Disease Undergoing Lower Extremity Revascularization Procedures

summary: The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the heart and brain (CV death, MI, or stroke) or the legs (acute limb ischemia or major amputation) in patients who had undergone recent procedure(s) to improve the blood flow of their legs.