title: A PHASE 2, 2-STAGE, 2-COHORT STUDY OF TALAZOPARIB (BMN 673) ADMINISTERED TO GERMLINE BRCA MUTATION SUBJECTS WITH LOCALLY ADVANCED AND/OR METASTATIC BREAST CANCER

acronym: ABRAZO

summary:
The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:

Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or
Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease

ReferenceCitation: Turner NC, Telli ML, Rugo HS, Mailliez A, Ettl J, Grischke EM, Mina LA, Balmaña J, Fasching PA, Hurvitz SA, Wardley AM, Chappey C, Hannah AL, Robson ME; ABRAZO Study Group. A Phase II Study of Talazoparib after Platinum or Cytotoxic Nonplatinum Regimens in Patients with Advanced Breast Cancer and Germline BRCA1/2 Mutations (ABRAZO). Clin Cancer Res. 2019 May 1;25(9):2717-2724. doi: 10.1158/1078-0432.CCR-18-1891. Epub 2018 Dec 18.

family: Turner

full_name: Nicholas C. Turner

given: Nicholas C.

family: Telli

full_name: Melinda L. Telli

given: Melinda L.

family: Rugo

full_name: Hope S. Rugo

given: Hope S.

family: Mailliez

full_name: Audrey Mailliez

given: Audrey

family: Ettl

full_name: Johannes Ettl

given: Johannes

family: Grischke

full_name: Eva-Maria Grischke

given: Eva-Maria

family: Mina

full_name: Lida A. Mina

given: Lida A.

family: Balmaña

full_name: Judith Balmaña

given: Judith

family: Fasching

full_name: Peter A. Fasching

given: Peter A.

family: Hurvitz

full_name: Sara A. Hurvitz

given: Sara A.

family: Wardley

full_name: Andrew M. Wardley

given: Andrew M.

family: Chappey

full_name: Colombe Chappey

given: Colombe

family: Hannah

full_name: Alison L. Hannah

given: Alison L.

family: Robson

full_name: Mark E. Robson

given: Mark E.

journal_name: Clinical Cancer Research

evidence: open (via free pdf)

publisher: American Association for Cancer Research (AACR)

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

lead_sponsor: Pfizer

location_country:
United States
France
Spain
Germany
United Kingdom

location_facility: IOZ Muenchen - lnerdisziplinaeres Onkologisches Zentrum

location_facility: Kliniken Essen Mitte Klinik fuer Gynaekologie und Gynaekologische Onkologie

location_facility: Cambridge University Hospital NHS Foundation Trust

location_facility: Hopitaux Universitaires de Strasbourg - Hopital Civil

location_facility: Indiana University Health Melvin and Bren Simon Cancer Center

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: MD Anderson Cancer Center International Espana

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Memorial Cancer Institute at Memorial Regional Hospital

location_facility: Memorial Sloan Kettering Evelyn H. Lauder Breast Center

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: Memorial Sloan Kettering Rockville Centre

location_facility: Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates

location_facility: Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Green Spring Station

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Anne Arundel Medical Center (AAMC), Annapolis Oncology and Hematology

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitario San Juan de Alicante

location_facility: University of Munich (LMU) Grosshadern Hospital

location_facility: g.SUND Gynaekologie Kompetenzzentrum Stralsund

location_facility: University of California, San Francisco: Helen Diller Comprehensive Cancer Center

location_facility: Anne Arundel Medical Center (AAMC), Research Pharmacy

location_facility: Klinikum Mutterhaus Der Borromaeerinnen Ggmbh

location_facility: Memorial Cancer Institute at Memorial Hospital West

location_facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.

location_facility: Memorial Breast Cancer Center at Memorial Hospital West

location_facility: UCLA West Medical Pharmacy Attn: Steven L. Wong, PharmD


type: EudraCT Number

type: Other Identifier

title: A Randomized, Double-blind, Placebo Controlled, 2-arm, Parallel-group, 26-week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin Therapy

summary: The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.

family: Cai

full_name: Jennifer Cai

given: Jennifer

sequence: first

family: Delahanty

full_name: Linda M. Delahanty

given: Linda M.

sequence: additional

family: Akapame

full_name: Sydney Akapame

given: Sydney

family: Slee

full_name: April Slee

given: April

family: Traina

full_name: Shana Traina

given: Shana

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Patient - Patient-Centered Outcomes Research

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
Germany
France
Australia
Canada

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceType: background

ReferenceCitation: Delea TE, Amdahl J, Boyko D, Hagiwara M, Zimmerman ZF, Franklin JL, Cong Z, Hechmati G, Stein A. Cost-effectiveness of blinatumomab versus salvage chemotherapy in relapsed or refractory Philadelphia-chromosome-negative B-precursor acute lymphoblastic leukemia from a US payer perspective. J Med Econ. 2017 Sep;20(9):911-922. doi: 10.1080/13696998.2017.1344127. Epub 2017 Jul 11.

ReferenceCitation: Kantarjian H, Stein A, Gökbuget N, Fielding AK, Schuh AC, Ribera JM, Wei A, Dombret H, Foà R, Bassan R, Arslan Ö, Sanz MA, Bergeron J, Demirkan F, Lech-Maranda E, Rambaldi A, Thomas X, Horst HA, Brüggemann M, Klapper W, Wood BL, Fleishman A, Nagorsen D, Holland C, Zimmerman Z, Topp MS. Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia. N Engl J Med. 2017 Mar 2;376(9):836-847. doi: 10.1056/NEJMoa1609783.

ReferenceCitation: Dombret H, Topp MS, Schuh AC, Wei AH, Durrant S, Bacon CL, Tran Q, Zimmerman Z, Kantarjian H. Blinatumomab versus chemotherapy in first salvage or in later salvage for B-cell precursor acute lymphoblastic leukemia. Leuk Lymphoma. 2019 Sep;60(9):2214-2222. doi: 10.1080/10428194.2019.1576872. Epub 2019 Apr 5.

ReferenceCitation: Kuchimanchi M, Zhu M, Clements JD, Doshi S. Exposure-response analysis of blinatumomab in patients with relapsed/refractory acute lymphoblastic leukaemia and comparison with standard of care chemotherapy. Br J Clin Pharmacol. 2019 Apr;85(4):807-817. doi: 10.1111/bcp.13864. Epub 2019 Feb 18.

ReferenceCitation: Stein AS, Larson RA, Schuh AC, Stevenson W, Lech-Maranda E, Tran Q, Zimmerman Z, Kormany W, Topp MS. Exposure-adjusted adverse events comparing blinatumomab with chemotherapy in advanced acute lymphoblastic leukemia. Blood Adv. 2018 Jul 10;2(13):1522-1531. doi: 10.1182/bloodadvances.2018019034.

ReferenceCitation: Topp MS, Zimmerman Z, Cannell P, Dombret H, Maertens J, Stein A, Franklin J, Tran Q, Cong Z, Schuh AC. Health-related quality of life in adults with relapsed/refractory acute lymphoblastic leukemia treated with blinatumomab. Blood. 2018 Jun 28;131(26):2906-2914. doi: 10.1182/blood-2017-09-804658. Epub 2018 May 8.

ReferenceCitation: Kantarjian HM, Zugmaier G, Brüggemann M, Wood BL, Horst HA, Zeng Y, Martinelli G. Impact of Blinatumomab Treatment on Bone Marrow Function in Patients with Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia. Cancers (Basel). 2021 Nov 9;13(22). pii: 5607. doi: 10.3390/cancers13225607.

ReferenceCitation: Jabbour E, Patel K, Jain N, Duose D, Luthra R, Short NJ, Zugmaier G, San Lucas A, Velasco K, Tran Q, Zaman F, Konopleva M, Kantarjian H. Impact of Philadelphia chromosome-like alterations on efficacy and safety of blinatumomab in adults with relapsed/refractory acute lymphoblastic leukemia: A post hoc analysis from the phase 3 TOWER study. Am J Hematol. 2021 Oct 1;96(10):E379-E383. doi: 10.1002/ajh.26281. Epub 2021 Jul 7.

name: Department of Leukemia The University of Texas MD Anderson Cancer Center  Houston Texas USA

family: Jabbour

full_name: Elias Jabbour

given: Elias

name: Department of Hematopathology The University of Texas MD Anderson Cancer Center  Houston Texas USA

family: Patel

full_name: Keyur Patel

given: Keyur

family: Jain

full_name: Nitin Jain

given: Nitin

name: Division of Pathology and Laboratory Medicine The University of Texas MD Anderson Cancer Center  Houston Texas USA

family: Duose

full_name: Dzifa Duose

given: Dzifa

family: Luthra

full_name: Rajyalakshmi Luthra

given: Rajyalakshmi

family: Short

full_name: Nicholas J. Short

given: Nicholas J.

name: Amgen Research (Munich) GmbH  Munich Germany

family: Zugmaier

full_name: Gerhard Zugmaier

given: Gerhard

name: Department of Epidemiology The University of Texas MD Anderson Cancer Center  Houston Texas USA

family: San Lucas

full_name: Anthony San Lucas

given: Anthony

name: Amgen Inc.  Thousand Oaks California USA

family: Velasco

full_name: Kelly Velasco

given: Kelly

family: Tran

full_name: Qui Tran

given: Qui

family: Zaman

full_name: Faraz Zaman

given: Faraz

family: Konopleva

full_name: Marina Konopleva

given: Marina

family: Kantarjian

full_name: Hagop Kantarjian

given: Hagop

journal_name: American Journal of Hematology

oa_host_type: publisher

evidence: open (via free article)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Impact of Philadelphia chromosome‐like alterations on efficacy and safety of blinatumomab in adults with relapsed/refractory acute lymphoblastic leukemia: A post hoc analysis from the phase 3 TOWER study

ReferenceCitation: Wei AH, Ribera JM, Larson RA, Ritchie D, Ghobadi A, Chen Y, Anderson A, Dos Santos CE, Franklin J, Kantarjian H. Biomarkers associated with blinatumomab outcomes in acute lymphoblastic leukemia. Leukemia. 2021 Aug;35(8):2220-2231. doi: 10.1038/s41375-020-01089-x. Epub 2021 Feb 4.

family: Wei

full_name: Andrew H. Wei

given: Andrew H.

family: Ribera

full_name: Josep-Maria Ribera

given: Josep-Maria

family: Larson

full_name: Richard A. Larson

given: Richard A.

family: Ritchie

full_name: David Ritchie

given: David

family: Ghobadi

full_name: Armin Ghobadi

given: Armin

family: Chen

full_name: Yuqi Chen

given: Yuqi

family: Anderson

repository_normalized: University of Melbourne - Minerva Access

ReferenceCitation: Rambaldi A, Huguet F, Zak P, Cannell P, Tran Q, Franklin J, Topp MS. Blinatumomab consolidation and maintenance therapy in adults with relapsed/refractory B-precursor acute lymphoblastic leukemia. Blood Adv. 2020 Apr 14;4(7):1518-1525. doi: 10.1182/bloodadvances.2019000874.

name: Università Statale di Milano, Milan and Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy;

name: Institut Universitaire du Cancer, Centre Hospitalier Universitaire de Toulouse, Toulouse, France;

name: Fakultni Nemocnice Hradec Králové, Hradec Králové, Czech Republic;

name: Fiona Stanley Hospital, Perth, Australia;

name: Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany

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

location_country:
Greece
Australia
Belgium
Russian Federation
Taiwan
France
Poland
Canada
Korea, Republic of
Bulgaria
Ireland
Germany
United States
United Kingdom
Italy
Austria
Mexico
Czechia
Israel
Spain
Turkey

title: A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study)

summary: The primary objective was to evaluate the effect of blinatumomab on overall survival when compared to standard of care (SOC) chemotherapy.


title: A Randomized, Controlled, Parallel Group, Double-blind, Multi-centre, Phase IIb Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in the AFFITOPE® AD02 Phase II Study AFF006.

summary: This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations in patients with Alzheimer's disease. Patients, who have already participated in AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation in the clinical trial is 19 months.

status: Terminated

lead_sponsor: Affiris AG

location_country:
Austria
Croatia
France
Slovakia
Germany
Czech Republic

location_facility: "BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju

location_facility: Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie

location_facility: Arzneimittelforschung Leipzig GmbH, Studienzentrum

location_facility: Opća bolnica Varaždin, Klinika za Neurologiju

location_facility: Centre Hospitalier Universitaire (CHU) de Dijon

location_facility: MUW Klin. Pharmakologie und Klinik für Neurologie

location_facility: Centre Mémoire de Ressources et de Recherche, Service de Neurologie

location_facility: Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie

location_facility: Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie

location_facility: University Hospital Motol, Clinic of Neurology

location_facility: Christian Doppler Klinik, Univ. Klinik f. Neurologie

location_facility: Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju

location_facility: CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard

location_facility: Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München

intervention_type: Biological

status_simplified: Unknown


title: A 24-week, Phase IIB, Randomized, Controlled, Parallel Group, Multi-center Study to Evaluate the Safety and Efficacy of GSK1278863 in Subjects With Anemia Associated With Chronic Kidney Diseases Who Are Not on Dialysis.

summary: This study will be conducted in approximately 228 subjects with anemia associated with CKD who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1: recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are currently receiving rhEPO. Subjects who are rhEPO naive will be randomized to receive either GSK1278863 once daily (QD) or rhEPO in a 3:1 fashion; subjects who are receiving an rhEPO before enrolling (rhEPO users) will be randomized in a 1:1 fashion to GSK1278863 QD or to the control arm. For those randomized to the control arm, the decision around whether the subject requires rhEPO, the selection of the type of rhEPO (if needed) and the choice of rhEPO dose to achieve and maintain Hgb concentrations within the target range should be based on Investigator clinical judgment, with the historical rhEPO dose and the current Hgb value being considered. The study consists of a screening phase of at least 4 weeks, a 24-week treatment phase and a follow-up visit that will occur approximately 4 weeks after completing treatment. It is anticipated that the data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.

lead_sponsor: GlaxoSmithKline

location_country:
United States
Sweden
Germany
France
Czechia
Japan
Poland
Hungary
Australia
Russian Federation
Spain
Denmark
Canada
United Kingdom
Korea, Republic of


type: U.S. NIH Grant/Contract

type: Other Grant/Funding Number

title: Age of Blood in Children in Pediatric Intensive Care Units

acronym: ABC-PICU

summary: ABC PICU is a randomized clinical trial that will compare the clinical consequences of RBC storage duration in 1538 critically ill children. Laboratory and observational evidence points to serious concerns about the lack of safety and effectiveness of older RBCs, especially in more vulnerable populations. Physicians and institutions have been systematically transfusing fresh RBCs to some pediatric patients primarily because of beliefs that the use of fresh RBCs improve outcomes. Conversely, the standard practice of blood banks is to deliver the oldest RBC unit in order to decrease blood wastage. To provide much needed high quality evidence to answer the question "do RBCs of reduced storage duration improve outcomes?" The ABC PICU Trial will conduct a RCT comparing development of New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS) in critically ill children transfused with either RBCs stored ≤ 7 days or standard issue RBCs (expected mean RBC storage duration of 17-21 days).

ReferenceCitation: Spinella PC, Tucci M, Fergusson DA, Lacroix J, Hébert PC, Leteurtre S, Schechtman KB, Doctor A, Berg RA, Bockelmann T, Caro JJ, Chiusolo F, Clayton L, Cholette JM, Guerra GG, Josephson CD, Menon K, Muszynski JA, Nellis ME, Sarpal A, Schafer S, Steiner ME, Turgeon AF; ABC-PICU Investigators, the Canadian Critical Care Trials Group, the Pediatric Acute Lung Injury and Sepsis Investigators Network, the BloodNet Pediatric Critical Care Blood Research Network, and the Groupe Francophone de Réanimation et Urgences P. Effect of Fresh vs Standard-issue Red Blood Cell Transfusions on Multiple Organ Dysfunction Syndrome in Critically Ill Pediatric Patients: A Randomized Clinical Trial. JAMA. 2019 Dec 10;322(22):2179-2190. doi: 10.1001/jama.2019.17478.

name: Division of Critical Care, Department of Pediatrics, Washington University School of Medicine in St Louis, St Louis, Missouri

family: Spinella

full_name: Philip C. Spinella

given: Philip C.

name: Division of Pediatric Critical Care, Centre Hospitalier Universitaire (CHU) Sainte-Justine, Université de Montréal and Centre de Recherche du Centre Hospitalier de l’Université de Montréal, Montreal, Quebec, Canada

family: Tucci

full_name: Marisa Tucci

given: Marisa

name: Ottawa Hospital Research Institute, Departments of Medicine & Surgery, University of Ottawa School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada

family: Fergusson

full_name: Dean A. Fergusson

given: Dean A.

family: Lacroix

full_name: Jacques Lacroix

given: Jacques

name: Département de médecine, Centre de recherche du CHUM and Chaire de médecine transfusionnelle Héma-Québec-Bayer de l'Université de Montréal, Centre hospitalier de l'Université de Montréal, Montreal, Quebec, Canada

family: Hébert

full_name: Paul C. Hébert

given: Paul C.

name: Université de Lille, EA 2694—Santé publique: épidémiologie et qualité des soins, CHU Lille, Réanimation Pédiatrique, Lille, France

family: Leteurtre

full_name: Stéphane Leteurtre

given: Stéphane

name: Division of Biostatistics, Washington University School of Medicine in St Louis, St Louis, Missouri

family: Schechtman

full_name: Kenneth B. Schechtman

given: Kenneth B.

family: Doctor

full_name: Allan Doctor

given: Allan

name: The Children’s Hospital of Philadelphia, Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia

family: Berg

full_name: Robert A. Berg

given: Robert A.

family: Bockelmann

full_name: Tina Bockelmann

given: Tina

name: London School of Economics, London, United Kingdom

family: Caro

full_name: J. Jaime Caro

given: J. Jaime

name: Department of Anesthesia and Critical Care, Bambino Gesù Children’s Hospital, Rome, Italy

family: Chiusolo

full_name: Fabrizio Chiusolo

given: Fabrizio

name: Division of Pediatric Critical, Department of Pediatrics, Centre Hospitalier Universitaire (CHU) Sainte-Justine Université de Montréal and Centre de Recherche du Centre Hospitalier de l’Université de Montréal, Montreal, Quebec, Canada

family: Clayton

full_name: Lucy Clayton

given: Lucy

name: Division of Critical Care and Cardiology, Department of Pediatrics, University of Rochester Golisano Children’s Hospital, Rochester, New York

family: Cholette

full_name: Jill M. Cholette

given: Jill M.

name: Department of Pediatrics, University of Alberta, Edmonton, Canada

name: Stollery Children’s Hospital, Edmonton, Alberta, Canada

family: Guerra

full_name: Gonzalo Garcia Guerra

given: Gonzalo Garcia

name: Departments of Pathology and Pediatrics, Emory University School of Medicine, Atlanta, Georgia

name: Transfusion, Tissue, Apheresis Services, Children’s Healthcare of Atlanta, Atlanta, Georgia

family: Josephson

full_name: Cassandra D. Josephson

given: Cassandra D.

name: Children’s Hospital of Eastern Ontario, University of Ottawa, Ottawa, Canada

family: Menon

full_name: Kusum Menon

given: Kusum

name: Division of Critical Care Medicine, Department of Pediatrics, Nationwide Children’s Hospital, Columbus, Ohio

family: Muszynski

full_name: Jennifer A. Muszynski

given: Jennifer A.

name: Division of Pediatric Critical Care, Department of Pediatrics, Weill Cornell Medicine, New York, New York

family: Nellis

full_name: Marianne E. Nellis

given: Marianne E.

name: Western University, Children's Hospital, London Health Sciences Centre, London, Ontario, Canada

family: Sarpal

full_name: Amrita Sarpal

given: Amrita

family: Schafer

full_name: Stephanie Schafer

given: Stephanie

name: Division of Pediatric Hematology and Oncology, Division of Pediatric Critical Care Medicine, Department of Pediatrics, University of Minnesota Medical School, Minneapolis

family: Steiner

full_name: Marie E. Steiner

given: Marie E.

name: Research CHU de Québec—Université Laval Centre, Population Health and Optimal Health Practices and Research Unit, Trauma, Emergency, Critical Care Medicine, Université Laval and Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Faculty of Medicine, Université Laval, Québec City, Québec, Canada

family: Turgeon

full_name: Alexis F. Turgeon

name: for the ABC-PICU Investigators, the Canadian Critical Care Trials Group, the Pediatric Acute Lung Injury and Sepsis Investigators Network, the BloodNet Pediatric Critical Care Blood Research Network, and the Groupe Francophone de Réanimation et Urgences P

ReferenceCitation: Tucci M, Lacroix J, Fergusson D, Doctor A, Hébert P, Berg RA, Caro J, Josephson CD, Leteurtre S, Menon K, Schechtman K, Steiner ME, Turgeon AF, Clayton L, Bockelmann T, Spinella PC; Canadian Critical Care Trials Group; Pediatric Critical Care Blood Research Network (BloodNet); Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial. Trials. 2018 Jul 28;19(1):404. doi: 10.1186/s13063-018-2809-y.

name: for the Canadian Critical Care Trials Group

name: the Pediatric Critical Care Blood Research Network (BloodNet)

name: the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network

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

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

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

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

location_country:
Italy
France
Israel
United States
Canada

location_facility: James Whitcomb Riley Hospital for Children

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Centre Hospitalier de I'Universite Laval

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: The Children's Hospital and University of Colorado Denver School of Medicine

location_facility: Hôpital Universitaire Necker - Enfants Malades


ReferenceType: result

ReferenceCitation: Nauck M, Rizzo M, Johnson A, Bosch-Traberg H, Madsen J, Cariou B. Once-Daily Liraglutide Versus Lixisenatide as Add-on to Metformin in Type 2 Diabetes: A 26-Week Randomized Controlled Clinical Trial. Diabetes Care. 2016 Sep;39(9):1501-9. doi: 10.2337/dc15-2479. Epub 2016 Jun 16.

family: Nauck

full_name: Michael Nauck

given: Michael

family: Rizzo

full_name: Manfredi Rizzo

given: Manfredi

family: Johnson

full_name: Andrew Johnson

given: Andrew

family: Bosch-Traberg

full_name: Heidrun Bosch-Traberg

given: Heidrun

family: Madsen

full_name: Jesper Madsen

given: Jesper

family: Cariou

full_name: Bertrand Cariou

given: Bertrand

journal_name: Diabetes Care

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

ReferenceCitation: Hunt B, Vega-Hernandez G, Valentine WJ, Kragh N. Evaluation of the long-term cost-effectiveness of liraglutide vs lixisenatide for treatment of type 2 diabetes mellitus in the UK setting. Diabetes Obes Metab. 2017 Jun;19(6):842-849. doi: 10.1111/dom.12890. Epub 2017 Feb 23.

name: Ossian Health Economics and Communications; Basel Switzerland

family: Hunt

full_name: Barnaby Hunt

given: Barnaby

family: Vega-Hernandez

full_name: Gabriela Vega-Hernandez

given: Gabriela

family: Valentine

full_name: William J. Valentine

given: William J.

family: Kragh

full_name: Nana Kragh

given: Nana

journal_name: Diabetes, Obesity and Metabolism

lead_sponsor: Novo Nordisk A/S

location_country:
Italy
United Kingdom
Finland
France
Lithuania
Hungary
Latvia
Germany
Czech Republic

acronym: LIRA-LIXI™

source: euctr

title: Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes

summary: This trial is conducted in Europe. The aim of the trial is to investigate the efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes (T2DM).


title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil

acronym: STARSHINE

summary: To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).

ReferenceCitation: Ballard C, Atri A, Boneva N, Cummings JL, Frölich L, Molinuevo JL, Tariot PN, Raket LL. Enrichment factors for clinical trials in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2019 May 20;5:164-174. doi: 10.1016/j.trci.2019.04.001. eCollection 2019.

name: University of Exeter Medical SchoolExeterUK

family: Ballard

full_name: Clive Ballard

given: Clive

name: Banner Sun Health Research InstituteSun CityAZUSA

name: Brigham and Women's Hospital and Harvard Medical SchoolBostonMAUSA

family: Atri

full_name: Alireza Atri

given: Alireza

family: Boneva

full_name: Neli Boneva

given: Neli

name: Cleveland Clinic Lou Ruvo Center for Brain HealthLas VegasNVUSA

family: Cummings

full_name: Jeffrey L. Cummings

given: Jeffrey L.

name: Central Institute of Mental HealthMedical Faculty MannheimUniversity of HeidelbergHeidelbergGermany

family: Frölich

full_name: Lutz Frölich

given: Lutz

name: Alzheimer's Disease and Other Cognitive Disorders Unit, IDIBAPSHospital Clinic i UniversitariBarcelonaSpain

name: Barcelonaβeta Brain Research CenterPasqual Maragall FoundationBarcelonaSpain

family: Molinuevo

full_name: José Luis Molinuevo

given: José Luis

family: Tariot

full_name: Pierre N. Tariot

given: Pierre N.

family: Raket

full_name: Lars Lau Raket

given: Lars Lau

currency_apc_doaj: USD

journal_name: Alzheimer's & Dementia: Translational Research & Clinical Interventions

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: Enrichment factors for clinical trials in mild‐to‐moderate Alzheimer's disease

ReferenceCitation: Cummings JL, Atri A, Ballard C, Boneva N, Frölich L, Molinuevo JL, Raket LL, Tariot PN. Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer's disease clinical program. Alzheimers Res Ther. 2018 Nov 24;10(1):116. doi: 10.1186/s13195-018-0443-2.

repository_institution: Heidelberg University - heiDOK - The Heidelberg Document Repository

title: Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer’s disease clinical program

ReferenceCitation: Atri A, Frölich L, Ballard C, Tariot PN, Molinuevo JL, Boneva N, Windfeld K, Raket LL, Cummings JL. Effect of Idalopirdine as Adjunct to Cholinesterase Inhibitors on Change in Cognition in Patients With Alzheimer Disease: Three Randomized Clinical Trials. JAMA. 2018 Jan 9;319(2):130-142. doi: 10.1001/jama.2017.20373.

name: Ray Dolby Brain Health Center, California Pacific Medical Center, San Francisco

name: Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

name: Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Heidelberg, Germany

name: University of Exeter Medical School, Exeter, England

name: Banner Alzheimer’s Institute, Phoenix, Arizona

name: Alzheimer’s Disease and Other Cognitive Disorders Unit, IDIBAPS, Hospital Clinic i Universitari, Barcelona, Spain

name: Barcelonaβeta Brain Research Centre, Pasqual Maragall Foundation, Barcelona, Spain

name: Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, Nevada

location_country:
Italy
United States
Chile
South Africa
Germany
France
Bulgaria
Czechia
Poland
Romania
Belgium
Argentina
Spain
Denmark
Canada
Ukraine


title: Efficacy, Safety and Tolerability of Multiple Doses of Oral Cebranopadol in Subjects With Moderate to Severe Chronic Pain Due to Diabetic Peripheral Neuropathy.

summary:
The purpose of this trial is to evaluate if cebranopadol is safe and can decrease pain in patients when compared to placebo (a tablet that does not contain active product) and when compared to a marketed product containing pregabalin (Lyrica®). Furthermore, this trial will be undertaken to find out if the patient's general health and well-being improves under trial treatment.

The concentrations of cebranopadol in the blood will be investigated to get a better understanding of how it is absorbed from the gut, distributed and broken down in the body, and eliminated from the body.

study_start_date_type: Actual

ipd_sharing: No

lead_sponsor: Tris Pharma, Inc.

location_country:
Italy
Austria
Netherlands
Germany
France
Spain
Denmark
United States


title: A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Placebo in Subjects With Relapsed/Refractory Indolent Lymphoma

acronym: AUGMENT

summary: This double-blind randomized, parallel group study will evaluate the efficacy and safety of lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination with rituximab. Anticipated time on study treatment is 1 year.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Morschhauser F, Fowler NH, Feugier P, Bouabdallah R, Tilly H, Palomba ML, Fruchart C, Libby EN, Casasnovas RO, Flinn IW, Haioun C, Maisonneuve H, Ysebaert L, Bartlett NL, Bouabdallah K, Brice P, Ribrag V, Daguindau N, Le Gouill S, Pica GM, Martin Garcia-Sancho A, López-Guillermo A, Larouche JF, Ando K, Gomes da Silva M, André M, Zachée P, Sehn LH, Tobinai K, Cartron G, Liu D, Wang J, Xerri L, Salles GA; RELEVANCE Trial Investigators. Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. N Engl J Med. 2018 Sep 6;379(10):934-947. doi: 10.1056/NEJMoa1805104.

name: From Université Lille, Centre Hospitalier Universitaire (CHU), Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille (F.M.), CHU Régional de Nancy, Service d’Hématologie, Vandoeuvre lès Nancy (P.F.), Institut Paoli-Calmettes (R.B.) and Department of Pathology, Institut Paoli-Calmettes, Centre de Recherche en Cancerologie de Marseille, INSERM, Centre National de la Recherche Scientifique, Aix-Marseille Université (L.X.), Marseille, Centre Henri Becquerel, Unité 1245 and...

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Fowler

full_name: Nathan H. Fowler

given: Nathan H.

family: Feugier

full_name: Pierre Feugier

given: Pierre

family: Bouabdallah

full_name: Reda Bouabdallah

given: Reda

family: Tilly

full_name: Hervé Tilly

given: Hervé

family: Palomba

full_name: M. Lia Palomba

given: M. Lia

family: Fruchart

full_name: Christophe Fruchart

given: Christophe

family: Libby

full_name: Edward N. Libby

given: Edward N.

family: Casasnovas

full_name: Rene-Olivier Casasnovas

given: Rene-Olivier

family: Flinn

full_name: Ian W. Flinn

given: Ian W.

family: Haioun

full_name: Corinne Haioun

given: Corinne

family: Maisonneuve

full_name: Hervé Maisonneuve

family: Ysebaert

full_name: Loic Ysebaert

given: Loic

family: Bartlett

full_name: Nancy L. Bartlett

given: Nancy L.

full_name: Kamal Bouabdallah

given: Kamal

family: Brice

full_name: Pauline Brice

given: Pauline

family: Ribrag

full_name: Vincent Ribrag

given: Vincent

family: Daguindau

full_name: Nicolas Daguindau

given: Nicolas

family: Le Gouill

full_name: Steven Le Gouill

given: Steven

family: Pica

full_name: Gian M. Pica

given: Gian M.

family: Martin Garcia-Sancho

full_name: Alejandro Martin Garcia-Sancho

given: Alejandro

family: López-Guillermo

full_name: Armando López-Guillermo

given: Armando

family: Larouche

full_name: Jean-François Larouche

given: Jean-François

ReferenceCitation: Leonard JP, Trneny M, Izutsu K, Fowler NH, Hong X, Zhu J, Zhang H, Offner F, Scheliga A, Nowakowski GS, Pinto A, Re F, Fogliatto LM, Scheinberg P, Flinn IW, Moreira C, Cabeçadas J, Liu D, Kalambakas S, Fustier P, Wu C, Gribben JG; AUGMENT Trial Investigators. AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2019 May 10;37(14):1188-1199. doi: 10.1200/JCO.19.00010. Epub 2019 Mar 21.

name: Weill Cornell Medicine and New York Presbyterian Hospital, New York, NY

name: Charles University, General Hospital, Prague, Czech Republic

name: National Cancer Center Hospital, Tokyo, Japan

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

name: Fudan University Shanghai Cancer Center, Shanghai, People’s Republic of China

name: Peking University Cancer Hospital and Institute, Beijing, People’s Republic of China

name: Tianjin Medical University Cancer Institute and Hospital, Tianjin, People’s Republic of China

name: Ghent University Hospital, Gent, Belgium

name: Instituto Nacional de Câncer, Rio de Janeiro, Brazil

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

name: Azienda Ospedaliero Universitaria di Parma, Parma, Italy

name: Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil

name: Hospital A Beneficência Portuguesa de São Paulo, São Paulo, Brazil

name: Sarah Cannon Research Institute, Nashville, TN

name: Instituto Português de Oncologia do Porto Francisco Gentil Epe, Porto, Portugal

name: Instituto Português de Oncologia de Lisboa Francisco Gentil, Lisbon, Portugal

name: Celgene International, Boudry, Switzerland

name: Barts Cancer Institute, London, United Kingdom

repository_institution: Ghent University - Ghent University Academic Bibliography

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

location_country:
Italy
Brazil
Spain
Germany
France
Czechia
Japan
Israel
Poland
Belgium
Puerto Rico
Russian Federation
China
Turkey
United States
United Kingdom
Portugal

location_facility: Centre Hospitalier Universitaire d'Avicennes

location_facility: Russian Academy of Medical Sciences Institution

location_facility: Nagoya Medical Center,Division of Hematology/Oncology

location_facility: Fakultni nemocnice Hradec Kralove, IV.interni hematologicka klinika

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: The Third Xiangya hospital of central south university

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: IRCCS- Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione "G. Pascale"

location_facility: Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin

location_facility: Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika

location_facility: Florida Cancer Specialists North Region Sarah Cannon Research

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

location_facility: Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie

location_facility: Fundação Antonio Prudente - AC Camargo Câncer center

location_facility: Mitchell Cancer Center, University of South Alabama

location_facility: The Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: University of Louisville, J.G. Brown Cancer Center

location_facility: Onkologische Schwerpunktpraxis Leer - Emden

location_facility: North County Hematology Oncology (NCHO) - TRM, LLC.

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi - Nesima

location_facility: Instytut Hematologii i Transfuzjologii w Warszawie

location_facility: Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento

location_facility: Chinese Academy of Medical Sciences & Peking Union Medical College

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi

location_facility: Instituto Portugues de Oncologia do Porto, Francisco Gentil

location_facility: Instituto Portugues de Oncologia de Lisboa, Francisco Gentil

location_facility: Hematology-Oncology Medical Group of Orange County, Inc.

location_facility: Azienda Ospedaliera S. Andrea - Università La Sapienza

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia

location_facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: The First Affiliated Hospital of Soochow University

location_facility: The Ministry of Health and Social Development of the Tula region state institution Health Tula regio

location_facility: The First Affiliated Hospital of Medical School of Zhejiang University

location_facility: Oncology Hematology Care Sarah Cannon Research

location_facility: Coborn Cancer Center at the St. Cloud Hospital

location_facility: Associacao Educudora Sao Carlos AESC Hospital Giovanni Battista HGB Hospital Mae de Deus Center

location_facility: Klinkum der Stadt Villingen-Schwenningen GmbH

location_facility: Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú

location_facility: Fakultni Nemocnice Ostrava, Klinika hematoonkologie,

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Hematology-Oncology Associates of Northern NJ

location_facility: Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute

location_facility: Southend University Hospital NHS Foundation Trust, Prittlewell Chase

location_facility: Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: St. Petersburg Pavlov State Medical University

location_facility: The Cancer Center at Hackensack University Medical Center

location_facility: Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

location_facility: Centro di Riferimento Oncologico - IRCCS

location_facility: Jiangsu Province Hospital The First Hospital affiliated with Nanjing Medical University

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: Kobe City Medical Center General Hospital

location_facility: Kocaeli Derince Training and Research Hospital

location_facility: Royal Liverpool University Hospital, Prescot Street

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: Barts Cancer Institute, Queen Mary University of London, Charterhouse Square

location_facility: Central Coast Medical Oncology Corporation

location_facility: West China Hospital of Sichuan University

location_facility: National University Corporation Tohoku University, Tohoku University Hospital

location_facility: Fujian Medical University Union Hospital

location_facility: Cukurova University Medical Faculty Balcali Hospital

location_facility: Charite - Universitaetsmedizin Berlin Campus Virchow Klinikum


title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Inadequately Controlled Asthma and High Bronchodilator Reversibility

summary: The purpose of this study is to determine if brodalumab (AMG 827) is safe and effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.

lead_sponsor: Amgen

location_country:
Italy
United States
Hong Kong
Germany
France
Poland
Greece
Ireland
Australia
Puerto Rico
New Zealand
Russian Federation
Canada
Korea, Republic of
Taiwan


title: A Randomized, Double-blind Study To Evaluate the Efficacy and Safety of Cabozantinib (XL184) at 60 mg/Day Compared to a 140 mg/Day in Progressive, Metastatic Medullary Thyroid Cancer Patients

acronym: EXAMINER

summary: The objective of this study is to evaluate the efficacy and safety of oral cabozantinib at a 60 mg dose compared with a 140 mg dose in subjects with progressive, metastatic MTC. It will test if the lower dose results in similar progression free survival (PFS) and overall response rate (ORR) with fewer adverse events compared to the PFS, ORR and adverse events found in previous clinical trials of 140 mg.

enrollment_type: Anticipated

lead_sponsor: Exelixis

location_country:
Italy
Sweden
Netherlands
Croatia
France
Poland
Israel
Romania
Hungary
Australia
Russian Federation
Spain
Canada
Korea, Republic of

status_simplified: Ongoing


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex

acronym: SYNERGY

summary:
The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex.

Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.

ReferenceCitation: Cadavid D, Mellion M, Hupperts R, Edwards KR, Calabresi PA, Drulović J, Giovannoni G, Hartung HP, Arnold DL, Fisher E, Rudick R, Mi S, Chai Y, Li J, Zhang Y, Cheng W, Xu L, Zhu B, Green SM, Chang I, Deykin A, Sheikh SI; SYNERGY study investigators. Safety and efficacy of opicinumab in patients with relapsing multiple sclerosis (SYNERGY): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2019 Sep;18(9):845-856. doi: 10.1016/S1474-4422(19)30137-1. Epub 2019 Jul 5.

family: Cadavid

full_name: Diego Cadavid

given: Diego

family: Mellion

full_name: Michelle Mellion

given: Michelle

family: Hupperts

full_name: Raymond Hupperts

given: Raymond

family: Edwards

full_name: Keith R Edwards

given: Keith R

family: Calabresi

full_name: Peter A Calabresi

given: Peter A

family: Drulović

full_name: Jelena Drulović

given: Jelena

family: Giovannoni

full_name: Gavin Giovannoni

given: Gavin

family: Hartung

full_name: Hans-Peter Hartung

given: Hans-Peter

family: Arnold

full_name: Douglas L Arnold

given: Douglas L

family: Fisher

full_name: Elizabeth Fisher

given: Elizabeth

family: Rudick

full_name: Richard Rudick

given: Richard

family: Mi

full_name: Sha Mi

given: Sha

family: Chai

full_name: Yi Chai

given: Yi

family: Li

full_name: Jie Li

given: Jie

family: Zhang

full_name: Yiwei Zhang

given: Yiwei

family: Cheng

full_name: Wenting Cheng

given: Wenting

family: Xu

full_name: Lei Xu

given: Lei

family: Zhu

full_name: Bing Zhu

given: Bing

family: Green

full_name: Susan M Green

given: Susan M

family: Chang

full_name: Ih Chang

given: Ih

family: Deykin

full_name: Aaron Deykin

given: Aaron

family: Sheikh

full_name: Sarah I Sheikh

given: Sarah I

family: Agüera Morales

full_name: Eduardo Agüera Morales

given: Eduardo

ReferenceCitation: Wilhelm H, Schabet M. The Diagnosis and Treatment of Optic Neuritis. Dtsch Arztebl Int. 2015 Sep 11;112(37):616-25; quiz 626. doi: 10.3238/arztebl.2015.0616. Review.

location_country:
Italy
Serbia
United Kingdom
Netherlands
France
Poland
Hungary
Russian Federation
Spain
United States
Czech Republic
Canada

location_facility: Fondazione Istituto San Raffaele G. Giglio di Cefalù

location_facility: Michigan Institute For Neurological Disorders

location_facility: Republican Clinical Hospital For Rehabilitation Treatment

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: M.A.- Lek A.M.Maciejowscy Spolka Cywilna

location_facility: Gabriela Klodowska-Duda Neuro-Care NZOZ Site Management Organization

location_facility: Nemocnice Jihlava Prispevkova Organizace

location_facility: Azienda Ospedaliera Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari

location_facility: City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31

location_facility: Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n. med. Hanka Hertmanowska

location_facility: Multiple Sclerosis Center of North Eastern New York

location_facility: Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny w Rybniku

location_facility: Azienda Ospedaliera S. Antonio Abate di Gallarate

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: OMRF Multiple Sclerosis Center of Excellence

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy

location_facility: Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego

location_facility: Jahn Ferenc Dél-Pesti Kórház és Rendelöintézet

location_facility: Krajska Zdravotni a.s. Nemocnice Teplice Oz

location_facility: Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele


title: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy.

summary: Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.

ReferenceCitation: Banerjee S, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, González-Martín A, Aghajanian C, Bradley WH, Holmes E, Lowe ES, DiSilvestro P. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Oct 26. pii: S1470-2045(21)00531-3. doi: 10.1016/S1470-2045(21)00531-3. [Epub ahead of print]

family: Banerjee

full_name: Susana Banerjee

given: Susana

family: Moore

full_name: Kathleen N Moore

given: Kathleen N

family: Colombo

full_name: Nicoletta Colombo

given: Nicoletta

family: Scambia

full_name: Giovanni Scambia

given: Giovanni

family: Kim

full_name: Byoung-Gie Kim

given: Byoung-Gie

family: Oaknin

full_name: Ana Oaknin

given: Ana

family: Friedlander

full_name: Michael Friedlander

given: Michael

family: Lisyanskaya

full_name: Alla Lisyanskaya

given: Alla

family: Floquet

full_name: Anne Floquet

given: Anne

family: Leary

full_name: Alexandra Leary

given: Alexandra

family: Sonke

full_name: Gabe S Sonke

given: Gabe S

family: Gourley

full_name: Charlie Gourley

given: Charlie

family: Oza

full_name: Amit Oza

given: Amit

family: González-Martín

full_name: Antonio González-Martín

given: Antonio

family: Aghajanian

full_name: Carol Aghajanian

given: Carol

family: Bradley

full_name: William H Bradley

given: William H

family: Holmes

full_name: Eileen Holmes

given: Eileen

family: Lowe

full_name: Elizabeth S Lowe

given: Elizabeth S

family: DiSilvestro

full_name: Paul DiSilvestro

given: Paul

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Friedlander M, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Lisyanskaya A, Sonke GS, Gourley C, Banerjee S, Oza A, González-Martín A, Aghajanian C, Bradley WH, Liu J, Mathews C, Selle F, Lortholary A, Lowe ES, Hettle R, Flood E, Parkhomenko E, DiSilvestro P. Patient-centred outcomes and effect of disease progression on health status in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation receiving maintenance olaparib or placebo (SOLO1): a randomised, phase 3 trial. Lancet Oncol. 2021 May;22(5):632-642. doi: 10.1016/S1470-2045(21)00098-X. Epub 2021 Apr 13.

ReferenceCitation: Moore K, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Banerjee S, Oza A, González-Martín A, Aghajanian C, Bradley W, Mathews C, Liu J, Lowe ES, Bloomfield R, DiSilvestro P. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2018 Dec 27;379(26):2495-2505. doi: 10.1056/NEJMoa1810858. Epub 2018 Oct 21.

name: From the Stephenson Cancer Center at the University of Oklahoma, Oklahoma City (K.M.); University of Milan–Bicocca, European Institute of Oncology Istituto di Ricovero e Cura a Carattere Scientifico, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica, Rome (G.S.) — both in Italy; Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (B.-G.K.); Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology, Barcelona (A....

repository_institution: University of Edinburgh - Edinburgh Research Explorer

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 request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Italy
Brazil
United States
Netherlands
Spain
France
Japan
Poland
Israel
Australia
Russian Federation
China
Canada
United Kingdom
Korea, Republic of

location_facility: First affiliated hospital college of XianJiaotong University

location_facility: University of Texas Health Science Center of Houston

location_facility: Cancer Research UK and UCL Cancer Trials Centre

location_facility: University of Mississippi Medical Center

location_facility: The Tumour Hospital of Harbin Medical University

location_facility: Peggy and Charles Stephenson Cancer Center

location_facility: Walter Reed National Military Medical Center

location_facility: Istituto Regina Elena-Polo Oncologico Ifo

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alagre

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna

location_facility: Nancy N. & J.C. Lewis Cancer and Research Pavillion

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: The Tumor Hospital affiliated to China Medical Science Insti

location_facility: Northern Indiana Cancer Research Consortium

location_facility: Udmurtia Republic Clinical Oncology Center

location_facility: Szpital Specjalistyczny im. Swietej Rodziny SPZOZ

location_facility: Royal Marsden Hospital and Institute of Cancer Research

location_facility: The First Affiliated Hospital of Soochow Universit

location_facility: Washington University School of Medicine

location_facility: West China Hospital Affiliated to Sichuan University

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: Cleveland Clinic Cancer Center at Fairview Hospital

location_facility: Istituto Nazionale Per Cura Tumori - Milano

location_facility: City Hospital, Birmingham, Cancer Trials Team

location_facility: State Institution of Heath Omsk Regional Oncology Dispensary

location_facility: St.Petersburg City Oncology Dispensary, Dept. Gynecology

location_facility: Obstetris and Gynecology Hospital of Fudan University

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

location_facility: Women's Hospital, Zhejaing University School of Medicine

location_facility: SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

location_facility: Chemotherapy Department, Russian Cancer Research Centre

location_facility: St. Vincent Hospital & Health Care Center

location_facility: Shanghai Cancer Hospital of Fudan University

location_facility: Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital

location_facility: Wojewódzki Szpital Specjalistyczny w Olsztynie

location_facility: University of Texas Southwestern Medical Center


title: A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma

summary: The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.

ReferenceCitation: Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hogg D, Hill A, Márquez-Rodas I, Haanen J, Guidoboni M, Maio M, Schöffski P, Carlino MS, Lebbé C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bastholt L, Rizzo JI, Balogh A, Moshyk A, Hodi FS, Wolchok JD. Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2019 Oct 17;381(16):1535-1546. doi: 10.1056/NEJMoa1910836. Epub 2019 Sep 28.

name: From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) — both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno...

family: Larkin

full_name: James Larkin

given: James

family: Chiarion-Sileni

full_name: Vanna Chiarion-Sileni

given: Vanna

family: Gonzalez

full_name: Rene Gonzalez

given: Rene

family: Grob

full_name: Jean-Jacques Grob

given: Jean-Jacques

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

family: Lao

full_name: Christopher D. Lao

given: Christopher D.

family: Cowey

full_name: C. Lance Cowey

given: C. Lance

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Wagstaff

full_name: John Wagstaff

given: John

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

family: Ferrucci

full_name: Pier F. Ferrucci

given: Pier F.

family: Smylie

full_name: Michael Smylie

family: Hogg

full_name: David Hogg

given: David

family: Hill

full_name: Andrew Hill

given: Andrew

family: Márquez-Rodas

full_name: Ivan Márquez-Rodas

given: Ivan

family: Haanen

full_name: John Haanen

family: Guidoboni

full_name: Massimo Guidoboni

given: Massimo

family: Maio

full_name: Michele Maio

given: Michele

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

family: Carlino

full_name: Matteo S. Carlino

given: Matteo S.

family: Lebbé

full_name: Céleste Lebbé

given: Céleste

family: McArthur

full_name: Grant McArthur

given: Grant

family: Ascierto

full_name: Paolo A. Ascierto

given: Paolo A.

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Hodi FS, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Cowey CL, Lao CD, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hill A, Hogg D, Marquez-Rodas I, Jiang J, Rizzo J, Larkin J, Wolchok JD. Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1480-1492. doi: 10.1016/S1470-2045(18)30700-9. Epub 2018 Oct 22. Erratum in: Lancet Oncol. 2018 Dec;19(12):e668. Lancet Oncol. 2018 Nov;19(11):e581.

ReferenceCitation: Wolchok JD, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao CD, Wagstaff J, Schadendorf D, Ferrucci PF, Smylie M, Dummer R, Hill A, Hogg D, Haanen J, Carlino MS, Bechter O, Maio M, Marquez-Rodas I, Guidoboni M, McArthur G, Lebbé C, Ascierto PA, Long GV, Cebon J, Sosman J, Postow MA, Callahan MK, Walker D, Rollin L, Bhore R, Hodi FS, Larkin J. Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2017 Oct 5;377(14):1345-1356. doi: 10.1056/NEJMoa1709684. Epub 2017 Sep 11. Erratum in: N Engl J Med. 2018 Nov 29;379(22):2185.

name: From the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W., M.A.P., M.K.C.); Oncology Institute of Veneto Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padua (V.C.-S.), European Institute of Oncology, Milan (P.F.F.), Center for Immuno-Oncology, University Hospital of Siena, Istituto Toscano Tumori, Siena (M.M.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.),...

repositories_institution:
PubMed Central - Europe PMC
Swansea University - Cronfa

ReferenceCitation: Long GV, Weber JS, Larkin J, Atkinson V, Grob JJ, Schadendorf D, Dummer R, Robert C, Márquez-Rodas I, McNeil C, Schmidt H, Briscoe K, Baurain JF, Hodi FS, Wolchok JD. Nivolumab for Patients With Advanced Melanoma Treated Beyond Progression: Analysis of 2 Phase 3 Clinical Trials. JAMA Oncol. 2017 Nov 1;3(11):1511-1519. doi: 10.1001/jamaoncol.2017.1588.

name: Melanoma Institute Australia, University of Sydney, Sydney, New South Wales, Australia3Mater Hospital, North Sydney, New South Wales, Australia

name: Department of Medical Oncology, Moffitt Cancer Center, Tampa, Florida5now with Department of Medical Oncology, Laura and Isaac Perlmutter Cancer Center, New York University Langone Medical Center, New York

name: Department of Oncology, Royal Marsden Hospital, London, United Kingdom

name: Gallipoli Medical Research Foundation and Princess Alexandra Hospital, and University of Queensland, Queensland, Australia

name: Department of Dermatology and Skin Cancer, Hospital Timone APHM, Aix-Marseille University, Marseille, France

name: Department of Skin, University Hospital Essen, Essen, Germany10Department of Urology, University Hospital Essen, Essen, Germany

name: Department of Dermatology, UniversitaetsSpital, Zurich, Switzerland

name: Department of Medicine Institute Gustave Roussy, Gustave Roussy and Paris-Sud University, Villejuif Paris-Sud, France

name: Servicio de Oncología Médica, Hospital General Universitario Gregorio Marañón, Madrid, Spain

name: Chris O’Brien Lifehouse, Melanoma Institute Australia, Camperdown, New South Wales, Australia15Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

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

name: Department of Medical Oncology, Coffs Harbour Health Campus, New South Wales, Australia

name: Melanoma Clinic at King Albert II Cancer Institute, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Bruxelles, Belgium

name: Melanoma Center and Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts

name: Ludwig Center for Cancer Immunotherapy at Memorial Sloan Kettering Cancer Center, New York, New York

ReferenceCitation: Schadendorf D, Larkin J, Wolchok J, Hodi FS, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao C, Wagstaff J, Callahan MK, Postow MA, Smylie M, Ferrucci PF, Dummer R, Hill A, Taylor F, Sabater J, Walker D, Kotapati S, Abernethy A, Long GV. Health-related quality of life results from the phase III CheckMate 067 study. Eur J Cancer. 2017 Sep;82:80-91. doi: 10.1016/j.ejca.2017.05.031. Epub 2017 Jun 23.

ReferenceCitation: Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015 Jul 2;373(1):23-34. doi: 10.1056/NEJMoa1504030. Epub 2015 May 31. Erratum in: N Engl J Med. 2018 Nov 29;379(22):2185.

name: From the Department of Medical Oncology, Royal Marsden Hospital, London (J.L.), and South West Wales Cancer Institute, Singleton Hospital, Swansea (J.W.) — both in the United Kingdom; Melanoma Oncology Unit, Veneto Region Oncology Research Institute, Padua (V.C.-S.), Oncology of Melanoma Unit, European Institute of Oncology, Milan (P.F.F.), University Hospital of Siena, Siena (M.M.), and Istituto Nazionale Tumori Fondazione Pascale, Naples (P.A.A.) — all in Italy; Division of Medical Oncology, University...

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

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

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

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: University Health Network - Princess Margaret Cancer Centre

location_facility: Desert Hematology Oncology Medical Group

location_facility: St. Luke's Cancer Center - Anderson Campus

location_facility: The Angeles Clinic And Research Institute.

location_facility: Comprehensive Cancer Center At Desert Regional Medical Ctr

location_facility: The University Of Texas MD Anderson Cancer Center

location_facility: Ucsf Helen Diller Family Comprehensive Cancer Center

location_facility: University Of Mississippi Medical Center

location_facility: Providence Cancer Center Oncology and Hematology Care- Eastside

location_facility: Washington University School Of Medicine

location_facility: California Pacific Medical Center Research Institute


title: A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects With Unresectable Pleural or Peritoneal Malignant Mesothelioma

acronym: Tremelimumab

summary: This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period.

ReferenceCitation: Baverel P, Roskos L, Tatipalli M, Lee N, Stockman P, Taboada M, Vicini P, Horgan K, Narwal R. Exposure-Response Analysis of Overall Survival for Tremelimumab in Unresectable Malignant Mesothelioma: The Confounding Effect of Disease Status. Clin Transl Sci. 2019 Sep;12(5):450-458. doi: 10.1111/cts.12633. Epub 2019 Apr 12.

family: Baverel

full_name: Paul Baverel

given: Paul

family: Roskos

full_name: Lorin Roskos

given: Lorin

family: Tatipalli

full_name: Manasa Tatipalli

given: Manasa

family: Lee

full_name: Nancy Lee

given: Nancy

family: Stockman

full_name: Paul Stockman

family: Taboada

full_name: Maria Taboada

given: Maria

family: Vicini

full_name: Paolo Vicini

given: Paolo

family: Horgan

full_name: Kevin Horgan

given: Kevin

family: Narwal

full_name: Rajesh Narwal

given: Rajesh

journal_name: Clinical and Translational Science

title: Exposure–Response Analysis of Overall Survival for Tremelimumab in Unresectable Malignant Mesothelioma: The Confounding Effect of Disease Status

ReferenceCitation: Maio M, Scherpereel A, Calabrò L, Aerts J, Perez SC, Bearz A, Nackaerts K, Fennell DA, Kowalski D, Tsao AS, Taylor P, Grosso F, Antonia SJ, Nowak AK, Taboada M, Puglisi M, Stockman PK, Kindler HL. Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial. Lancet Oncol. 2017 Sep;18(9):1261-1273. doi: 10.1016/S1470-2045(17)30446-1. Epub 2017 Jul 17.

family: Scherpereel

full_name: Arnaud Scherpereel

given: Arnaud

family: Calabrò

full_name: Luana Calabrò

given: Luana

family: Aerts

full_name: Joachim Aerts

given: Joachim

family: Perez

full_name: Susana Cedres Perez

given: Susana Cedres

family: Bearz

full_name: Alessandra Bearz

given: Alessandra

family: Nackaerts

full_name: Kristiaan Nackaerts

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 request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

location_country:
Italy
United States
South Africa
Sweden
Netherlands
Germany
France
Poland
Israel
Romania
Hungary
Belgium
Australia
Russian Federation
Spain
Denmark
Canada
United Kingdom
Korea, Republic of


title: Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)

acronym: PREAMBLE

summary: This is a non-interventional observational study aimed at understanding the real world effectiveness of novel agents used in treating multiple myeloma and their impact on patient-reported outcomes. This study will collect information that is already in medical records regarding treatment and diagnostic procedures. Patients are asked to complete questionnaires for patient-reported outcome measures.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
France
Germany
United Kingdom
Canada

location_facility:
Local Institute
Local Institution


summary: This is a multicentre, prospective, observational post-market registry (follow-up 1 month, 1 year, 2 years, 3 years, 4 years and 5 years) to monitor the post-market clinical safety and effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft in patients with a short infrarenal neck of <15mm or juxta-renal abdominal aortic aneurysms who, in the opinion of the treating physician, are anatomically suitable for the AnacondaTM Custom Fenestrated Stent Graft and for whom a customised medical device is required.

lead_sponsor: Vascutek Ltd.

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
United Kingdom
Germany
France
Belgium
Spain
Canada
Monaco

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervel

location_facility: Imperial (St Mary's / Charing X) Hospital

location_facility: Medical Care Centre for Vascular Diseases


title: A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects

summary: The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.

ReferenceCitation: Mills A, Arribas JR, Andrade-Villanueva J, DiPerri G, Van Lunzen J, Koenig E, Elion R, Cavassini M, Madruga JV, Brunetta J, Shamblaw D, DeJesus E, Orkin C, Wohl DA, Brar I, Stephens JL, Girard PM, Huhn G, Plummer A, Liu YP, Cheng AK, McCallister S; GS-US-292-0109 team. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study. Lancet Infect Dis. 2016 Jan;16(1):43-52. doi: 10.1016/S1473-3099(15)00348-5. Epub 2015 Nov 2.

family: Mills

full_name: Anthony Mills

given: Anthony

family: Arribas

full_name: Jose R Arribas

given: Jose R

family: Andrade-Villanueva

full_name: Jaime Andrade-Villanueva

given: Jaime

family: DiPerri

full_name: Giovanni DiPerri

given: Giovanni

family: Van Lunzen

full_name: Jan Van Lunzen

given: Jan

family: Koenig

full_name: Ellen Koenig

given: Ellen

family: Elion

full_name: Richard Elion

given: Richard

family: Cavassini

full_name: Matthias Cavassini

given: Matthias

family: Madruga

full_name: Jose Valdez Madruga

given: Jose Valdez

family: Brunetta

full_name: Jason Brunetta

given: Jason

family: Shamblaw

full_name: David Shamblaw

given: David

family: DeJesus

full_name: Edwin DeJesus

given: Edwin

family: Orkin

full_name: Chloe Orkin

given: Chloe

family: Wohl

full_name: David A Wohl

given: David A

family: Brar

full_name: Indira Brar

given: Indira

family: Stephens

full_name: Jeffrey L Stephens

given: Jeffrey L

family: Girard

full_name: Pierre-Marie Girard

given: Pierre-Marie

family: Huhn

full_name: Gregory Huhn

given: Gregory

family: Plummer

full_name: Andrew Plummer

given: Andrew

family: Liu

full_name: Ya-Pei Liu

given: Ya-Pei

family: Cheng

full_name: Andrew K Cheng

given: Andrew K

family: McCallister

full_name: Scott McCallister

given: Scott

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

ReferenceCitation: Orkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Mills A, Vandercam B, de Wet J, Rockstroh J, Lazzarin A, Rijnders B, Podzamczer D, Thalme A, Stoeckle M, Porter D, Liu HC, Cheng A, Quirk E, SenGupta D, Cao H. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017 May;4(5):e195-e204. doi: 10.1016/S2352-3018(17)30031-0. Epub 2017 Mar 2.

ReferenceCitation: Brown T, Yin MT, Gupta S, Katlama C, et al. Switching from TDF to TAF in HIV-infected adults with low BMD: a pooled analysis. 24th Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2017; poster presentation: abstract #683.

ReferenceCitation: Podzamczer D, Viciana P, Rijnders B, Shalit P, et al. Switching from Tenofovir disoproxil fumarate to tenofovir alafenamide in patients with high risk for chronic kidney disease. 8th National Congress of the AIDS Study Group (GESIDA) and Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) held jointly with the 9th Teacher Meeting of AIDS Research Network 2016; poster presentation: abstract #P-188.

ReferenceCitation: Orkin C, Rjinders B, Stephan C, McKellar M, et al. Switching from boosted atazanavir (ATV) plus FTC/TDF to a TAF-based single tablet regimen (STR): Week 48 data in virologically suppressed adults. Annual Conference of the British Association for Sexual Health and HIV (BASHH) 2016; poster presentation: abstract # P045.

ReferenceCitation: Mills A, Andrade J, Koenig E, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 13th Congress for Infectious Diseases and Tropical Medicine (KIT) 2016; poster presentation: abstract #eP-038.

ReferenceCitation: Overton ET, Shalit P, Crofoot G, Benson P, et al. Switch from TDF regimens to E/C/F/TAF is associated with improved bone mineral density (BMD), decreased serum PTH and decreased bone turnover biomarkers. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; poster presentation: abstract #PW-027.

ReferenceCitation: Huhn G, Rijnders B, Thompson M, Tebas P, et al. Switching from TDF to TAF in patients with high risk for CKD. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; oral presentation: https://www.natap.org/2016/HIV/062116_01.htm.

ReferenceCitation: Abram M, Margot NA, Cox S, Ram RR, et al. Pooled week-48 analysis of HIV-1 drug resistance in E/C/F/TAF (Genvoya) phase 3 studies. 23rd Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2016, poster presentation: abstract #496.

ReferenceCitation: Abram M, Margot NA, Cox S, Ram RR, et al. Pooled week-48 analysis of HIV-1 drug resistance in E/C/F/TAF (Genvoya) phase 3 studies. 25th International HIV Drug Resistance Workshop - Informed Horizons, LLC 2016; poster presentation: abstract #33.

ReferenceCitation: Mills A, Andrade J, Di Perri G, Van Lunzen J, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 8th Biennial Conference on HIV Pathogenesis and Treatment and Prevention of the International AIDS Society (IAS) 2015; oral presentation: abstract #TUAB0102.

ReferenceCitation: Shamblaw D, Van Lunzen J, Orkin C, Bloch M, eta al. Switching from Atripla (ATR) to a tenofovir alafenamide (TAF)-based single tablet regimen: week 48 data in virologically suppressed adults. 55th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) 2015; oral presentation; https://natap.org/2015/ICAAC/ICAAC_13.htm.

ReferenceCitation: Thompson M, Morales-Ramirez J, Mcdonald C, Rachlis A, et al. Switching from a tenofovir disoproxil fumarate (TDF) to a tenofovir alafenamide (TAF)-based single tablet regimen (STR): Week 48 data in HIV-1 infected virologically suppressed adults. Spring Conference of the Society for Healthcare Epidemiology of America (SHEA) 2015; oral presentation: abstract #725.

ReferenceCitation: Rijnders B, Stephan C, Lazzarin A, Squires K, et al. Switching from ritonavir or cobicistat boosted atazanavir (ATV) plus emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) to a tenofovir alafenamide (TAF)-based single tablet regimen (STR): week 48 data in virologically suppressed adults. 15th European AIDS Conference (EACS) and 17th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV 2015; poster presentation: abstract #577.

ReferenceCitation: Lutz T, Benson P, Goffard J-C, Haubrich R, et al. Patient reported outcomes (PRO) over 48 weeks in a randomized, open-label trial of patients with HIV switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF). 15th European AIDS Conference (EACS) and 17th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV 2015; poster presentation: abstract #324.

ReferenceCitation: Viciana P, Mills A, Andrade J, Diperri G, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 7th National Congress of the AIDS Study Group (GESIDA) and Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) held jointly with the 8th Teacher Meeting of AIDS Research Network 2015; oral presentation: abstract #PO-08.

ReferenceCitation: Mills A, Andrade-Villanueva J, DiPerri G, Van Luzen J, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: Data in virologically suppressed adults through 48 weeks of treatment. 8th Annual International AIDS Society meeting 2015; oral presentation: abstract #839.

ReferenceCitation: Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide vs tenofovir DF in women: pooled analysis of 7 clinical trials. Annual Meeting of the American Pharmacists Association (APhA) - Virtual 2020; poster presentation: abstract #209.

ReferenceCitation: Stellbrink H, Gandhi-Patel B, Zhong L, Das M, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. Annual Meeting of the American Pharmacists Association (APhA) - Virtual 2020; poster presentation: abstract #205.

ReferenceCitation: Stellbrink H-J, Post FA, Podzamczer D, Arribas J, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. 15th Congress on Infectious Diseases and Tropical Medicine - German Society for Infectious Diseases (DPID) held jointly with the 29th Annual Meeting of the German Society for Pediatric Infectiology (DGPI) 2020; poster presentation: abstract #A-343.

ReferenceCitation: Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223.

repositories_institution:
Indiana University - IUScholarWorks
PubMed Central - Europe PMC

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Hermansson L, Yilmaz A, Price RW, Nilsson S, McCallister S, Makadzange T, Das M, Zetterberg H, Blennow K, Gisslen M. Plasma concentration of neurofilament light chain protein decreases after switching from tenofovir disoproxil fumarate to tenofovir alafenamide fumarate. PLoS One. 2019 Dec 11;14(12):e0226276. doi: 10.1371/journal.pone.0226276. eCollection 2019.

repository_institution: Chalmers University of Technology - Chalmers Research

repository_institution: University College London - UCL Discovery

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

repositories: California Digital Library - eScholarship

repositories_institution: Chalmers University of Technology - Chalmers Research

repositories_institution: University College London - UCL Discovery

repositories_institution: University of California - eScholarship University of California

ReferenceCitation: Stellbrink H-J, Post FA, Podzamczer D, Arribas J, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. 17th European AIDS Conference of the European AIDS Clinical Society (EACS) 2019; poster presentation: abstract #PE9-50.

ReferenceCitation: Pepperrell T, Hughes S, Gotham D, Pozniak A, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate - is there a true difference in safety? 17th European AIDS Conference of the European AIDS Clinical Society (EACS) 2019; poster presentation: abstract #PE3-8.

ReferenceCitation: Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide vs. tenofovir DF in women: pooled analysis of 7 clinical trials. 9th Edition International Workshop on HIV and Women - Virology Education 2019; poster presentation: abstract #21.

ReferenceCitation: Dejesus E, Federico Andrade Villanueva J, Ramon Arribas Lopez J, Brinson C, et al. Tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in hispanic/latinx and black participants: efficacy, bone and renal safety results from a pooled analysis of 7 clinical trials. IDWeek Meeting of the Infectious Diseases Society of America (IDSA) 2019; poster presentation: abstract #318.

ReferenceCitation: Walmsley S, Andany N, Brar I, Brinson C, et al. Tenofovir alafenamide VS tenofovir DF in women: pooled analysis of 7 clinical trials. 28th Annual Canadian Conference on HIV/AIDS Research - Canadian Association for HIV Research (CAHR) 2019; poster presentation: abstract #CSP9.04.

ReferenceCitation: Kim YS, Oka S, Chetchotisakd P, Clarke A, Supparatpinyo K, Avihingsanon A, Ratanasuwan W, Kiertiburanakul S, Ruxrungtham K, Yang S, Guo S, Liu Y, Das M, Tran D, McColl D, Corales R, Nguyen C, Piontkowsky D. Efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in Asian participants with human immunodeficiency virus 1 infection: A sub-analysis of phase 3 clinical trials. HIV Res Clin Pract. 2019 Jul 8:1-9. doi: 10.1080/15284336.2019.1589232. [Epub ahead of print]

name: Chungnam National University, Daejeon, South Korea;

name: National Center for Global Health and Medicine Hospital, Tokyo, Japan;

name: Khon Kaen University, Khon Kaen, Thailand;

name: Brighton and Sussex University Hospitals NHS Trust, Brighton, UK;

name: Chiang Mai University, Chiang Mai, Thailand;

name: Thai Red Cross AIDS Research Centre, Bangkok, Thailand;

name: Siriraj Hospital, Mahidol University, Bangkok, Thailand;

name: Ramathibodi Hospital, Mahidol University, Bangkok, Thailand;

name: Thai Red Cross AIDS Research Centre (HIV-NAT), Bangkok, Thailand;

name: Gilead Sciences, Foster City, California, USA

ReferenceCitation: Hermansson L, Price RW, Yilmaz A, Nilsson S, et al. Effect on plasma NFL, a marker or neuronal injury, after switching from TDF to TAF. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2019; oral presentation: abstract #127.

ReferenceCitation: Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide VS tenofovir DF in women: pooled analysis of 7 clinical trials. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2019; poster presentation: abstract #519.

ReferenceCitation: Orkin C, Castelli F, Yazdanpanah Y, Rockstroh J, et al. Cardiovascular disease risk assessments and fasting lipid changes in virologically suppressed patients randomized to switch to tenofovir alafenamide versus continuing tenofovir disoproxil fumarate. 22nd International AIDS Conference - International AIDS Society 2018; poster presentation: abstract #TUPEB104.

ReferenceCitation: Brown TT, Yin MT, Gupta SK, Short WR, et al. Combined effects of bisphosphonates & TDF->TAF switch in HIV+ adults with low BMD. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2018; poster presentation: abstract #724.

ReferenceCitation: DeJesus E, Haas B, Segal-Maurer S, Ramgopal MN, Mills A, Margot N, Liu YP, Makadzange T, McCallister S. Superior Efficacy and Improved Renal and Bone Safety After Switching from a Tenofovir Disoproxil Fumarate- to a Tenofovir Alafenamide-Based Regimen Through 96 Weeks of Treatment. AIDS Res Hum Retroviruses. 2018 Apr;34(4):337-342. doi: 10.1089/AID.2017.0203. Epub 2018 Mar 20.

name: Orlando Immunology Center, Orlando, Florida.

name: Department für Gastroenterologie mit Infektiologie, LKH Graz South-West, Graz, Austria.

name: Department of Infectious Diseases, NewYork-Presbyterian Queens, Flushing, New York.

name: Midway Immunology Center, Ft. Pierce, Florida.

name: Southern California Men's Medical Group, Los Angeles, California.

name: Gilead Sciences, Inc., Foster City, California.

ReferenceCitation: Goldstein D, Ward D, Brinson C, Crofoot G, et al. Week 96 efficacy and safety of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in older, HIV-Infected virologically-suppressed adults. Annual Meeting of the American Geriatrics Society (AGS) 2017; poster presentation: abstract #A90.

ReferenceCitation: Ward D, Thompson M, Goldstein D, Brinson C, et al. Week 96 efficacy and safety of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in older, HIV-infected treatment-naïve adults. Annual Meeting of the American Geriatrics Society (AGS) 2017; poster presentation: abstract #A91.

ReferenceCitation: Choe S, Podzamvzer D, Tashima K, McNicholl I, and McCallister S. Utilizing phase 3 clinical trial data to assess adverse event (AE) frequency of a potentially interacting medication (PIM) amlodipine with elvitegravir/cobicistat (EVG/COBI). Midyear Clinical Meeting of the American Society of Health-System Pharmacists (ASHP) 2017; poster presentation: abstract #7-068.

ReferenceCitation: Yin M, Gupta S, Nguyen-Cleary T, Mora M, and Das M. Switching from TDF to TAF in HIV-infected adults with low BMD: A pooled analysis. Congress on HIV and Hepatitis in the Americas - ViiV Healthcare UK Limited 2017; poster presentation: abstract #P021.

ReferenceCitation: Podzamczer D, Tashima K, Daar E, McGowan J, et al. Utilizing phase 3 clinical trial data to assess adverse event (AE) frequency of a potentially interacting medication (PIM) amlodipine with elvitegravir/cobicistat (EVG/COBI). International Congress of Drug Therapy in HIV Infection - International AIDS Society 2016; poster presentation: abstract #P314.

ReferenceCitation: Dejesus E, Haas B, Segal-Maurer S, Ramgopal M, et al. Superior efficacy and improved renal and bone safety after switching from a tenofovir disoproxil fumarate (TDF) regimen to a tenofovir alafenamide (TAF) based regimen through 96 weeks (W96) of treatment. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; poster presentation: abstract # LB-087.

ReferenceCitation: Viciana P, Rijnders B, Shalit P, Liu Y et al. Cambio desde TDF a TAF en pacientes en alto riesgo de erc. 18th Congress of the Andalusian Society of Infectious Diseases (SAID) 2016; poster presentation: abstract #P-070.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

location_country:
Italy
Austria
Brazil
Sweden
Switzerland
Mexico
Netherlands
Germany
Spain
Dominican Republic
France
Thailand
Australia
Belgium
Puerto Rico
Portugal
Denmark
United States
United Kingdom
Canada

location_facility: University of Hawaii - Hawaii Center for AIDS

location_facility: Beth Israel Medical Center- Division of Infectious Diseases

location_facility: Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg

location_facility: University Health Network, Toronto General Hospital

location_facility: University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit

location_facility: Baystate Infectious Diseases Clinical Research

location_facility: Center for HIV and Hepatogastroenterology

location_facility: SMZ Baumgartner Hoehe - Otto-Wagner-Spital

location_facility: Comprensorio Amedeo Di Savoia Birago Di Vische

location_facility: Servico De Doencas Infecciosas - Hospital De Sao Joao

location_facility: Onze Lieve Vrouwe Gasthuis, Afdeling Infectieziekten

location_facility: Michael Keith Wensley, MD, Inc., A Medical Corporation

location_facility: Yale University HIV Clinical Trials Program

location_facility: São Paulo Secretaria da Saúde - Centro de Referência e Treinamento em DST/AIDS

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: George Washington University Medical Faculty Associates

location_facility: Instituto Dominicano de Estudios Virologicos - IDEV

location_facility: HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University

location_facility: Instituto De Pesquisa Clinica Evandro Chagas - Fundação Oswaldo Cruz

location_facility: Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine

location_facility: McGill University Health Centre (MUHC) - Montral Chest Institute

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Ramathibodi Hospital, Mahidol University

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: Southwest Infectious Disease Clinical Research, Inc.

location_facility: Tarrant County Infectious Disease Associates

location_facility: University of NC AIDS Clinical Trials Unit

location_facility: La Playa Medical Group and Clinical Research

location_facility: Community Research Initiative of New England

location_facility: Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS

location_facility: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

location_facility: Universitätsklinik für Infektiologie, Universitätsspital Bern

location_facility: Broward Health/Comprehensive Care Center

location_facility: University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department

location_facility: São Paulo Secretaria da Saúde - Instituto De Infectologia Emilio Ribas

location_facility: University of California, Davis Medical Center

location_facility: Siriraj HospitalDepartment of Preventive and Social Medicine, Faculty of Medicine

location_facility: Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)

location_facility: Infektio Research GmbH / Infektiologikum Frankfurt

location_facility: University of Cologne, Department of Internal Medicine

location_facility: Chelsea and Westminster Hospital Foundation Trust

location_facility: Infectious Disease Research Institute Inc.

location_facility: North Shore University Hospital, Divison of Infectious Diseases

location_facility: Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Kaiser Permanente Medical Center, Clinical Trials Unit

location_facility: St. Joseph's Comprehensive Research Institute


title: A Randomized, Double-blind, Double-dummy, Multi-center Study to Assess Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Emergency Presentation at the Hospital Because of Worsening Chronic Heart Failure With Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone Versus Eplerenone

acronym: ARTS-HF

summary: To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.

ReferenceCitation: Filippatos G, Anker SD, Böhm M, Gheorghiade M, Køber L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Kim SY, Nowack C, Palombo G, Kolkhof P, Kimmeskamp-Kirschbaum N, Pieper A, Pitt B. A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease. Eur Heart J. 2016 Jul 14;37(27):2105-14. doi: 10.1093/eurheartj/ehw132. Epub 2016 Apr 29.

family: Filippatos

full_name: Gerasimos Filippatos

given: Gerasimos

family: Anker

full_name: Stefan D. Anker

given: Stefan D.

family: Böhm

full_name: Michael Böhm

given: Michael

family: Gheorghiade

full_name: Mihai Gheorghiade

given: Mihai

family: Køber

full_name: Lars Køber

given: Lars

family: Krum

full_name: Henry Krum

given: Henry

family: Maggioni

full_name: Aldo P. Maggioni

given: Aldo P.

family: Ponikowski

full_name: Piotr Ponikowski

given: Piotr

family: Voors

full_name: Adriaan A. Voors

given: Adriaan A.

family: Zannad

full_name: Faiez Zannad

given: Faiez

family: Kim

full_name: So-Young Kim

given: So-Young

family: Nowack

full_name: Christina Nowack

given: Christina

family: Palombo

full_name: Giovanni Palombo

given: Giovanni

family: Kolkhof

full_name: Peter Kolkhof

given: Peter

family: Kimmeskamp-Kirschbaum

full_name: Nina Kimmeskamp-Kirschbaum

given: Nina

family: Pieper

full_name: Alexander Pieper

given: Alexander

family: Pitt

full_name: Bertram Pitt

given: Bertram

journal_name: European Heart Journal

evidence: open (via page says license)

repository_institution: University of Copenhagen - Research at the University of Copenhagen

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

ReferenceCitation: Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10:CD007004. doi: 10.1002/14651858.CD007004.pub4.

name: Department of Medicine; Royal North Shore Hospital; Sydney Australia

name: Sydney School of Public Health; The University of Sydney; Sydney Australia

name: Department of Emergency and Organ Transplantation; University of Bari; Bari Italy

name: Institute of Clinical Physiology; CNR - Italian National Council of Research; Reggio Calabria Italy

name: Baylor College of Medicine; Houston Texas USA

name: Department of Medicine; University of Otago Christchurch; Christchurch New Zealand

name: Cochrane Kidney and Transplant, Centre for Kidney Research; The Children's Hospital at Westmead; Westmead Australia

ReferenceCitation: Pitt B, Anker SD, Böhm M, Gheorghiade M, Køber L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Nowack C, Kim SY, Pieper A, Kimmeskamp-Kirschbaum N, Filippatos G. Rationale and design of MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF): a randomized study of finerenone vs. eplerenone in patients who have worsening chronic heart failure with diabetes and/or chronic kidney disease. Eur J Heart Fail. 2015 Feb;17(2):224-32. doi: 10.1002/ejhf.218.

name: University of Michigan Medical School; 1500 E Medical Center Drive, 3910 Tauman Ctr Ann Arbor MI 48109 0366 USA

name: Department of Innovative Clinical Trials; University Medical Centre Göttingen; Göttingen Germany

name: Universitätskliniken des Saarlandes; Klinik für Innere Medizin III Homburg Germany

name: Feinberg School of Medicine; Northwestern University; Chicago IL USA

name: Heart Centre, Rigshospitalet; University of Copenhagen; Denmark

name: Centre of Cardiovascular Research and Education in Therapeutics; Monash University; Melbourne Australia

name: Research Centre of the Italian Association of Hospital Cardiologists; Florence Italy

name: Medical University; Clinical Military Hospital; Wrocław Poland

name: University Medical Centre Groningen; Groningen Netherlands

name: CHU Department of Cardiology; Université de Lorraine; Nancy France

name: Global Clinical Development; Bayer HealthCare AG; Leverkusen Germany

name: M.A.R.C.O. GmbH & Co. KG; Düsseldorf Germany

name: Global Research & Development Statistics; Bayer HealthCare AG; Leverkusen Germany

name: Department of Cardiology; Attikon University Hospital; Athens Greece

location_country:
Finland
Greece
Australia
Denmark
Taiwan
France
Poland
Lithuania
Norway
Canada
Korea, Republic of
South Africa
Sweden
Netherlands
Bulgaria
Hungary
Portugal
United States
Germany
Italy
Austria
Czechia
Israel
Spain
Turkey