title: A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naïve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo

summary: The purpose of this multi-center study in non-dialysis participants with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.

ReferenceCitation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Poland
United Kingdom
Argentina
Romania
Australia
Brazil
Mexico
United States
Korea, Republic of
Spain
Canada
Russian Federation
France


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

summary: This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.

location_facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

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

location_facility: INEP Medical s.r.o. Institut Neuropsychiatricke Pece

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Australian Alzheimer's Research Foundation

location_facility: Centro San Giovanni di Dio - Fatebenefratelli

location_facility: South London and Maudsley NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

location_facility: MAC Clinical Research - Barnsley Site #671

location_facility: Meridien Research - Lakeland Site Site #558

location_facility: Five Towns Neurology PC/Village Site #764

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Wasatch Clinical Research, LLC Site #771

location_facility: Premier Clinical Research Institute, Inc.

location_facility: Azienda Sanitaria Locale di Biella - Nuovo Ospedale degli Infermi

location_facility: Research Institute for the Care of Older People

location_facility: Dr. Kenessey Albert Kórház-Rendelőintézet

location_facility: Diagnostic-consultative center Mladost-М Varna OOD #711

location_facility: Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois

location_facility: Alzheimer's Research and Treatment Center

location_facility: CRU Hungary Egészségügyi és Szolgáltató Korlátolt Felelősségű Társaság

location_facility: Clinline Services s.r.0 Psychiatricka ambulance

location_facility: Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico

location_facility: Mental Health Centre Prof.Nikola Shipkovenski #713

location_facility: Petz Aladár Egyetemi Oktató Kórház Site# 594

location_facility: Wielospecjalistyczna Poradnia Lekarska Synapsis #741

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Clinical Research Associates of South Florida

location_facility: Complejo Asistencial de Zamora Hospital Virgen de la Concha

location_facility: Torrance Clinical Research Institute, Inc.

location_facility: Fundació Hospital de la Santa Creu i Sant Pau

location_facility: Fakultni Nemocnice u sv. Anny v Brne #722

location_facility: Neurology of Central Florida Rsch Ctr # 803

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Centre Hospitalier Universitaire Dijon Bourgogn

location_facility: University Multiprofile Hospital for Active Treatment Alexandrovska

location_facility: DCC "Sv. Vrach and Sv. Sv. Kuzma and Damian" OOD

location_facility: Neurologiczny Niepubliczny Zakład Opieki Zdrowotnej

location_facility: University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Adaptive Clinical Research, Inc. Site# 815

location_facility: Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord

location_facility: Valeomed Egeszsegugyi es Szolgaltato Kft

location_facility: Amonaria Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger-Molenda

location_facility: Alliance for Wellness, Inc dba Alliance for Research

location_facility: Centre Hospitalier Universitaire de Nantes - Hôpital Nord Laennec

location_facility: Centre Hospitalier Universitaire Toulouse - Casselardit Ancely

location_facility: Hospital Universitario y Politécnico de La Fe

location_facility: North West Boroughs Healthcare NHS Foundation Trust

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Twoja Przychodnia - Centrum Medyczne Nowa Sol #757

location_facility: Paradigm Clinical Research Centers, Inc.

location_facility: Avon and Wiltshire Mental Health Partnership NHS Trust

location_facility: Northamptonshire Healthcare NHS Foundation Trust

location_facility: Innovative Clinical Research, Inc Site #819

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Trinity Universal Research Associates Site #821

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Dr. Mathe es Tarsa Beteti Tarsasa Site #593

location_facility: Przychodnia Specjalistyczna Prosen Site#758

location_facility: Università degli studi G.D'Annunzio Chieti Pescara

location_facility: Negron Research Services / Humanity Clinical Research

location_facility: First Multiprofile Hospital for Active Treatment Sofia

location_facility: Beautiful Minds Clinical Research Center #808

location_facility: Nathan S. Kline Institute for Psychiatric Research

location_facility: Fejér Megyei Szent György Egyetemi Oktató Kórház

status: Active, not recruiting

title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

ipd_sharing_description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

design_allocation: Randomized

study_completion_date_type: Anticipated

location_country:
Italy
Poland
Hungary
United Kingdom
Australia
United States
Spain
South Africa
Czechia
Bulgaria
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Ongoing


lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.

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

location_facility: Hospital Nuestra Señora de la Misericordia

location_facility: Detweiler Family Medicine and Associates

location_facility: Dr. Anil K Gupta Medicine Professional Corporation

location_facility: Carolina Institute for Clinical Research

location_facility: FSBI 'Scientific and Research Institute of Flu' of the MoH of the RF

location_facility: NZOZ Centrum Badań Klinicznych,Piotr Napora,Lekarze Spółka Partnerska

location_facility: SBEI HPE 'Yaroslavl State Medical University' of the MoH of the RF

location_facility: Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA

location_facility: J. Lewis Research Inc./Jordan River Family Medicine

location_facility: Institute Of Epidimiology And Microbiology

location_facility: Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.

location_facility: Preferred Primary Care Physicians Research

location_facility: SMZ Süd - Kaiser Franz Josef Spital Wien

location_facility: Taipei Medical University Shuang-Ho Hospital

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Fuzhou General Hospital of Nanjing Military Command

location_facility: University Of Texas Medical Branch At Galveston

location_facility: Limited Liability company 'MSMC' Euromed

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C.

location_facility: Irmandade Da Santa Casa de Misericordia de Sao Paulo

location_facility: Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'

location_facility: Taipei Medical University-Wan Fang Hospital

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Powiatowe Centrum Medyczne w Wołowie Sp. z o.o.

location_facility: LLC Outpatient department of Private Security Guards and Detectives

location_facility: HIRG, LLC dba Health Innovation Research Group

location_facility: CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.

location_facility: J. Lewis research Inc./ Foothill Family Care

location_facility: Vilnius University Hospital Santaros Klinikos, Public Institution

location_facility: University of Texas Southwestern Medical Center

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Rajiv Gandhi Institute of Medical Sciences

location_facility: Odesa City Municipal Institution Polyclinic #20

location_facility: Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut

location_facility: The Catholic university of Korea, ST Vincent Hospital

location_facility: Centro de Estudos Clínicos do Interior Paulista - CECIP

location_facility: California Allergy & Asthma Medical Group Inc.

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

location_facility: Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelő Budai Családközpontú

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: Hospital Civil de Guadalajara Dr. Juan I. Menchaca

location_facility: Inese Petrova General Practitioner Practice

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: Inlita, JSC, Lazdynai KTC clinical trial site

location_facility: Suretech Hospital and Research Centre Limited

location_facility: Department for Heart Failure and Valvular Disease

location_facility: J. Lewis research Inc./ Foothill Family Clinic South

location_facility: Siauliai Republican Hospital, Public Institution

location_facility: Med San Unit OJSC Kharkiv S.OrdzhonikidzeTractor Plant Dept of Ther KMA PGE

location_facility: Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Bamrasnaradura Infectious Disease Institute

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

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

location_facility: Johns Hopkins University School of Medicine

location_facility: Hallym University Dongtan Sacred Heart Hospital

location_facility: Hospital Interzonal General de Agudos Dr. Jose Penna

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Nemocnica arm. generala L. Svobodu Svidnik, a.s.,

location_facility: San Diego Sports Medicine & Family Health Center

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

status: Terminated

title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection Who Are at Risk of Developing Complications

type: Other Identifier

study_completion_date_type: Actual

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Vietnam
Turkey
Chile
Czechia
Canada
France
Lithuania
Slovakia
Hungary
United States
Latvia
Ukraine
India
Belgium
China
Malaysia
Peru
Estonia
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

status_simplified: Unknown


title: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally-advanced Pancreatic Adenocarcinoma

summary:
Brief Summary:

The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic adenocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.

ReferenceCitation: Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.

ReferenceCitation: Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbaly V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.

ReferenceCitation: Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.

ReferenceCitation: Giladi M, Schneiderman RS, Voloshin T, Porat Y, Munster M, Blat R, Sherbo S, Bomzon Z, Urman N, Itzhaki A, Cahal S, Shteingauz A, Chaudhry A, Kirson ED, Weinberg U, Palti Y. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells. Sci Rep. 2015 Dec 11;5:18046. doi: 10.1038/srep18046.

ReferenceCitation: Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: Université de Lausanne - SERVAL

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

ReferenceCitation: Giladi M, Schneiderman RS, Porat Y, Munster M, Itzhaki A, Mordechovich D, Cahal S, Kirson ED, Weinberg U, Palti Y. Mitotic disruption and reduced clonogenicity of pancreatic cancer cells in vitro and in vivo by tumor treating fields. Pancreatology. 2014 Jan-Feb;14(1):54-63. doi: 10.1016/j.pan.2013.11.009. Epub 2013 Dec 4.

ReferenceCitation: Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718. Erratum In: JAMA. 2018 May 1;319(17):1824.

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

lead_sponsor: NovoCure Ltd.

location_country:
Germany
Poland
Australia
Brazil
Croatia
Czechia
Canada
France
Hungary
Hong Kong
Switzerland
United States
Belgium
China
Italy
Austria
Mexico
Korea, Republic of
Spain
Israel

location_facility: White Plains Hospital - Center for Cancer Care

location_facility: St. Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: West Virginia University Cancer Institute

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: Texas Oncology - Baylor - US Oncology Research

location_facility: Centre Hospitalier de I'Universitaire de de Montreal (CHUM)

location_facility: Associated Neurologists of Southern Connecticut, P.C.

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

location_facility: Groupo Clinicas Oncologicas Integradas (COI) - Barra da Tijuca

location_facility: Jan Mikulicz-Radecki University Teaching Hospital

location_facility: Renown Institute for Heart & Vascular Health

location_facility: Hopital haut-Léveque CHU Bordeaux - Service d'Hépato- Gastroentérologie et d'Oncologie digestive

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - US Oncology Research

location_facility: Arizona Oncology Associates, PC- HOPE - US Oncology Research

location_facility: A.O.U Città della Salute e della Scienza di Torino

location_facility: London Regional Cancer Program, London Health Sciences Centre

location_facility: Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)

location_facility: Boca Raton Regional Hospital, Lynn Cancer Institute

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Service d'Oncologie médicale du Pr. Andre, Hôpital Saint-Antoine

location_facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

location_facility: Maryland Oncology Hematology, P.A - US Oncology Research

location_facility: Centro de Estudios de Alta Especialidad de Sinaloa, ubicado

location_facility: University of Kansas Medical Cancer Center

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

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: University of Oklahoma Health Sciences Center

location_facility: Willamette Valley Cancer Institute and Research Center - US Oncology Research

location_facility: Phylasis Clinicas Research S. de R.L. de C.V.

location_facility: Central Maine Medical Center, Clinical Research Department

location_facility: Norton Cancer Institute, Norton Healthcare Pavilion

location_facility: Oncology Clinic Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu

location_facility: Centro de Investigación Médica Aguascalientes (CIMA),

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Centre Paul Strauss

location_facility: Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina

location_facility: Texas Oncology - El Paso Cancer Treatment Center Gateway - US Oncology Research

location_facility: IRPCc - Instituto Ribeirãopretano de Combate ao Câncer

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

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Instituto D'Or de Pesquisa e Ensino - Rio De Janeiro

location_facility: Hospital Regional Universitario de Málaga

location_facility: Texas Oncology - Bedford - US Oncology Reasearch

location_facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

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

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo

location_facility: A.O. SS Antonio e Biagio e Cesare Arrigo

location_facility: Centre Hospitalier de Bretagne Sud /Site du Scorff

location_facility: Rambam Health Care Campus, Oncology Institute

location_facility: Harbin Medical University Cancer Hospital

location_facility: Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center - US Oncology Research

location_facility: Centro Potosino de Investigación Médica SC,

location_facility: Universidad Autonoma de Nuevo Leon - Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Clinique Universutaire Saint Luc - Institut Roi Albert II

location_facility: Oncology and Radiotherapy Clinic, Oncology Center - Institute

location_facility: Clinique Sainte Anne - Groupe Hospitalier Saint-Vincent, Strasbourg Oncologie Libérale

location_facility: Phylasis Clinicas Research S.de R.L. de C.V. (PCR)-Toluca

location_facility: Sourasky Medical Center, Oncology Department

location_facility: Bonifatius Hospital Hematology and Oncology

location_facility: Texas Oncology - Tyler - US Oncology Research

location_facility: Medizinische Hochschule Hannover, Klinik fur Gastroenterologie, Hepatologie und Endokrinologie

location_facility: Centre Hospitalier Universitaire de Sherbrooke CIUSSS de l'Estrie - CHUS

location_facility: HM Hospitales - Centro Integral Oncologico Clara Campal - CIOCC

location_facility: Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael

location_facility: Florida Cancer Specialists & Research Institute - Colonial Office

location_facility: Cancer and Hematology Centers of Western Michigan, PC

location_facility: Adventist Health St. Helena - Martin-O'Neil Cancer Center (MOCC)

location_facility: Centro de Pesquisa Clínica e Ensino Florianópolis LTDA

location_facility: Illinois Cancer Specialist - US Oncology Research

location_facility: Univ. Klinik für Innere Medizin III der PMU

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Klinikum München Bogenhausen, Klinik für Gastroenterologie und Gastroenterologische Onkologie

location_facility: Oncology and Radiotherapy Clinic University Clinical Center Non-Invasive Medicine Center

location_facility: University of Maryland Comprehensive Cancer Center

intervention_type: Device


lead_sponsor: Hoffmann-La Roche

summary: This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC).

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie

location_facility: Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer

location_facility: Florida Cancer Specialists & Research Institute

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

location_facility: Klinikum Frankfurt Höchst GmbH; Klinik für Gynäkologie und Geburtshilfe

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

location_facility: Centre Georges-François Lecler; Ctr de Lutte Contre le Canc

location_facility: James Lind Centro de Investigación Del Cáncer

location_facility: the First Affiliated Hospital of Bengbu Medical College

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Instituto de Pesquisa Grupo NotreDame Intermedica

location_facility: First Hospital of China Medical University

location_facility: ?wi?tokrzyskie Centrum Onkologii; Dzia? Chemioterapii

location_facility: Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Institut Paoli-Calmettes; Oncologie Medicale 1

location_facility: Private Healthcare Institution Clinical Hospital RZhD Medicine

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Fujian Medical University Union Hospital

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases

location_facility: Western General Hospital; Edinburgh Cancer Center

location_facility: Oncocentro Serviços Medicos E Hospitalares Ltda

location_facility: Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Kazakh Scientific Research Institution Of Oncology and Radiology

location_facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin?

location_facility: Ege University Medical Faculty; Medical Oncology Department

location_facility: Bradford Hill Centro de Investigaciones Clinicas

location_facility: Centro de Oncologia de Santa Catarina LTDA

location_facility: Hacettepe University Medical Faculty; Department of Internal Medicine

location_facility: Tennessee Oncology; Sarah Cannon Research Institute

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: Cancer Hospital , Chinese Academy of Medical

location_facility: Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie

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

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Wits Clinical Research; Charlotte Maxeke Johannesburg Academic Hospital

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz;Sugarterapias Klinikai Onkologiai Intez

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA

location_facility: Centre Hospitalier Universitaire Hassan II

location_facility: The Affiliated Hospital of Medical College Qingdao University

location_facility: Clinique specialise Menara; Oncology Medical

location_facility: CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO

location_facility: Seoul National University Bundang Hospital

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Institut National D'oncologie Sidi Med Benabdellah

location_facility: Harbin Medical University Cancer Hospital

location_facility: Medical Oncology Centre of Rosebank; Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

location_facility: Marmara University Pendik Training and Research Hospital; Medikal Onkoloji

location_facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

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

location_facility: City Clinical Oncology Dispensary, SPb SBIH CCOD

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: National Cancer Centre; Medical Oncology

location_facility: The First Affiliated Hospital Of Jinzhou Medical University

location_facility: Fudan University Shanghai Cancer Center; Medical Oncology

location_facility: INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Ankara Oncology Hospital; Medical Oncology Department

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: The First Affiliated Hospital, Chongqing Medical University

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Instituto Nacional de Oncología y Radiología (INOR)

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe

location_facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Clinical Center of Montenegro; Clinic for Oncology and Radiotherapy

location_facility: Medipol University Medical Faculty; Oncology Department

location_facility: The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Clinical Centre Nis, Clinic for Oncology

location_facility: Magee-Woman's Hospital; UPMC Pinnacle Cancer Center

title: A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast Cancer

location_country:
Finland
Germany
Poland
Argentina
Brazil
Bosnia and Herzegovina
Turkey
Chile
Serbia
France
Portugal
Montenegro
Hungary
United States
Morocco
China
Cuba
Peru
Italy
United Kingdom
Singapore
Mexico
Korea, Republic of
Spain
Panama
South Africa
Russian Federation
Kazakhstan


lead_sponsor: Boehringer Ingelheim

summary: The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.

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ReferenceCitation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

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repositories_institution: University College London - UCL Discovery

repositories_institution: University of Illinois at Chicago - INDIGO

publisher_dissemination: American Diabetes Association

ReferenceCitation: Kahl S, Ofstad AP, Zinman B, Wanner C, Schuler E, Sattar N, Inzucchi SE, Roden M. Effects of empagliflozin on markers of liver steatosis and fibrosis and their relationship to cardiorenal outcomes. Diabetes Obes Metab. 2022 Jun;24(6):1061-1071. doi: 10.1111/dom.14670. Epub 2022 Mar 8.

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ReferenceCitation: Ruggenenti P, Kraus BJ, Inzucchi SE, Zinman B, Hantel S, Mattheus M, von Eynatten M, Remuzzi G, Koitka-Weber A, Wanner C. Nephrotic-range proteinuria in type 2 diabetes: Effects of empagliflozin on kidney disease progression and clinical outcomes. EClinicalMedicine. 2021 Dec 24;43:101240. doi: 10.1016/j.eclinm.2021.101240. eCollection 2022 Jan.

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ReferenceCitation: Reifsnider OS, Kansal AR, Wanner C, Pfarr E, Koitka-Weber A, Brand SB, Stargardter M, Wang C, Kuti E, Ustyugova A. Cost-Effectiveness of Empagliflozin in Patients With Diabetic Kidney Disease in the United States: Findings Based on the EMPA-REG OUTCOME Trial. Am J Kidney Dis. 2022 Jun;79(6):796-806. doi: 10.1053/j.ajkd.2021.09.014. Epub 2021 Nov 6.

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ReferenceCitation: Ferreira JP, Inzucchi SE, Mattheus M, Meinicke T, Steubl D, Wanner C, Zinman B. Empagliflozin and uric acid metabolism in diabetes: A post hoc analysis of the EMPA-REG OUTCOME trial. Diabetes Obes Metab. 2022 Jan;24(1):135-141. doi: 10.1111/dom.14559. Epub 2021 Oct 4.

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ReferenceCitation: Vaduganathan M, Inzucchi SE, Sattar N, Fitchett DH, Ofstad AP, Brueckmann M, George JT, Verma S, Mattheus M, Wanner C, Zinman B, Butler J. Effects of empagliflozin on insulin initiation or intensification in patients with type 2 diabetes and cardiovascular disease: Findings from the EMPA-REG OUTCOME trial. Diabetes Obes Metab. 2021 Dec;23(12):2775-2784. doi: 10.1111/dom.14535. Epub 2021 Oct 7.

ReferenceCitation: Sharma A, Ofstad AP, Ahmad T, Zinman B, Zwiener I, Fitchett D, Wanner C, George JT, Hantel S, Desai N, Mentz RJ. Patient Phenotypes and SGLT-2 Inhibition in Type 2 Diabetes: Insights From the EMPA-REG OUTCOME Trial. JACC Heart Fail. 2021 Aug;9(8):568-577. doi: 10.1016/j.jchf.2021.03.003.

ReferenceCitation: Cherney DZI, Dagogo-Jack S, McGuire DK, Cosentino F, Pratley R, Shih WJ, Frederich R, Maldonado M, Liu J, Wang S, Cannon CP; VERTIS CV Investigators. Kidney outcomes using a sustained >/=40% decline in eGFR: A meta-analysis of SGLT2 inhibitor trials. Clin Cardiol. 2021 Aug;44(8):1139-1143. doi: 10.1002/clc.23665. Epub 2021 Jun 15.

ReferenceCitation: Ferreira JP, Kraus BJ, Zwiener I, Lauer S, Zinman B, Fitchett DH, Koitka-Weber A, George JT, Ofstad AP, Wanner C, Zannad F. Cardio/Kidney Composite End Points: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial. J Am Heart Assoc. 2021 Apr 6;10(7):e020053. doi: 10.1161/JAHA.120.020053. Epub 2021 Mar 23.

ReferenceCitation: Ferreira JP, Verma S, Fitchett D, Ofstad AP, Lauer S, Zwiener I, George J, Wanner C, Zinman B, Inzucchi SE. Metabolic syndrome in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a post hoc analyses of the EMPA-REG OUTCOME trial. Cardiovasc Diabetol. 2020 Nov 26;19(1):200. doi: 10.1186/s12933-020-01174-6.

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PubMed Central
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ReferenceCitation: McGuire DK, Zinman B, Inzucchi SE, Wanner C, Fitchett D, Anker SD, Pocock S, Kaspers S, George JT, von Eynatten M, Johansen OE, Jamal W, Mattheus M, Elsasser U, Hantel S, Lund SS. Effects of empagliflozin on first and recurrent clinical events in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a secondary analysis of the EMPA-REG OUTCOME trial. Lancet Diabetes Endocrinol. 2020 Dec;8(12):949-959. doi: 10.1016/S2213-8587(20)30344-2.

ReferenceCitation: Ceriello A, Ofstad AP, Zwiener I, Kaspers S, George J, Nicolucci A. Empagliflozin reduced long-term HbA1c variability and cardiovascular death: insights from the EMPA-REG OUTCOME trial. Cardiovasc Diabetol. 2020 Oct 13;19(1):176. doi: 10.1186/s12933-020-01147-9.

ReferenceCitation: Neeland IJ, Eliasson B, Kasai T, Marx N, Zinman B, Inzucchi SE, Wanner C, Zwiener I, Wojeck BS, Yaggi HK, Johansen OE; EMPA-REG OUTCOME Investigators. The Impact of Empagliflozin on Obstructive Sleep Apnea and Cardiovascular and Renal Outcomes: An Exploratory Analysis of the EMPA-REG OUTCOME Trial. Diabetes Care. 2020 Dec;43(12):3007-3015. doi: 10.2337/dc20-1096. Epub 2020 Oct 1.

ReferenceCitation: Levin A, Perkovic V, Wheeler DC, Hantel S, George JT, von Eynatten M, Koitka-Weber A, Wanner C; EMPA-REG OUTCOME Investigators. Empagliflozin and Cardiovascular and Kidney Outcomes across KDIGO Risk Categories: Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled, Multinational Trial. Clin J Am Soc Nephrol. 2020 Oct 7;15(10):1433-1444. doi: 10.2215/CJN.14901219. Epub 2020 Sep 29.

ReferenceCitation: Waijer SW, Xie D, Inzucchi SE, Zinman B, Koitka-Weber A, Mattheus M, von Eynatten M, Inker LA, Wanner C, Heerspink HJL. Short-Term Changes in Albuminuria and Risk of Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial. J Am Heart Assoc. 2020 Sep 15;9(18):e016976. doi: 10.1161/JAHA.120.016976. Epub 2020 Sep 6.

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ReferenceCitation: Bohm M, Fitchett D, Ofstad AP, Brueckmann M, Kaspers S, George JT, Zwiener I, Zinman B, Wanner C, Marx N, Mancia G, Anker SD, Mahfoud F. Heart failure and renal outcomes according to baseline and achieved blood pressure in patients with type 2 diabetes: results from EMPA-REG OUTCOME. J Hypertens. 2020 Sep;38(9):1829-1840. doi: 10.1097/HJH.0000000000002492.

ReferenceCitation: Inzucchi SE, Khunti K, Fitchett DH, Wanner C, Mattheus M, George JT, Ofstad AP, Zinman B. Cardiovascular Benefit of Empagliflozin Across the Spectrum of Cardiovascular Risk Factor Control in the EMPA-REG OUTCOME Trial. J Clin Endocrinol Metab. 2020 Sep 1;105(9):3025-35. doi: 10.1210/clinem/dgaa321.

ReferenceCitation: Ferreira JP, Fitchett D, Ofstad AP, Kraus BJ, Wanner C, Zwiener I, Zinman B, Lauer S, George JT, Rossignol P, Zannad F. Empagliflozin for Patients With Presumed Resistant Hypertension: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial. Am J Hypertens. 2020 Dec 31;33(12):1092-1101. doi: 10.1093/ajh/hpaa073.

ReferenceCitation: Perkovic V, Koitka-Weber A, Cooper ME, Schernthaner G, Pfarr E, Woerle HJ, von Eynatten M, Wanner C. Choice of endpoint in kidney outcome trials: considerations from the EMPA-REG OUTCOME(R) trial. Nephrol Dial Transplant. 2020 Dec 4;35(12):2103-2111. doi: 10.1093/ndt/gfz179.

ReferenceCitation: Kansal A, Reifsnider OS, Proskorovsky I, Zheng Y, Pfarr E, George JT, Kandaswamy P, Ruffolo A. Cost-effectiveness analysis of empagliflozin treatment in people with Type 2 diabetes and established cardiovascular disease in the EMPA-REG OUTCOME trial. Diabet Med. 2019 Nov;36(11):1494-1502. doi: 10.1111/dme.14076. Epub 2019 Jul 23.

ReferenceCitation: Butler J, Zannad F, Fitchett D, Zinman B, Koitka-Weber A, von Eynatten M, Zwiener I, George J, Brueckmann M, Cheung AK, Wanner C. Empagliflozin Improves Kidney Outcomes in Patients With or Without Heart Failure. Circ Heart Fail. 2019 Jun;12(6):e005875. doi: 10.1161/CIRCHEARTFAILURE.118.005875. Epub 2019 Jun 5.

ReferenceCitation: Verma S, Wanner C, Zwiener I, Ofstad AP, George JT, Fitchett D, Zinman B; EMPA-REG OUTCOME Investigators. Influence of Microvascular Disease on Cardiovascular Events in Type 2 Diabetes. J Am Coll Cardiol. 2019 Jun 4;73(21):2780-2782. doi: 10.1016/j.jacc.2019.03.002. Epub 2019 Mar 15. No abstract available.

ReferenceCitation: Januzzi J, Ferreira JP, Bohm M, Kaul S, Wanner C, Brueckmann M, Petrie MC, Ofstad AP, Zeller C, George J, Fitchett D, Zannad F. Empagliflozin reduces the risk of a broad spectrum of heart failure outcomes regardless of heart failure status at baseline. Eur J Heart Fail. 2019 Mar;21(3):386-388. doi: 10.1002/ejhf.1419. Epub 2019 Feb 14. No abstract available.

ReferenceCitation: Fitchett D, Inzucchi SE, Cannon CP, McGuire DK, Scirica BM, Johansen OE, Sambevski S, Kaspers S, Pfarr E, George JT, Zinman B. Empagliflozin Reduced Mortality and Hospitalization for Heart Failure Across the Spectrum of Cardiovascular Risk in the EMPA-REG OUTCOME Trial. Circulation. 2019 Mar 12;139(11):1384-1395. doi: 10.1161/CIRCULATIONAHA.118.037778.

ReferenceCitation: Verma S, Mazer CD, Fitchett D, Inzucchi SE, Pfarr E, George JT, Zinman B. Empagliflozin reduces cardiovascular events, mortality and renal events in participants with type 2 diabetes after coronary artery bypass graft surgery: subanalysis of the EMPA-REG OUTCOME(R) randomised trial. Diabetologia. 2018 Aug;61(8):1712-1723. doi: 10.1007/s00125-018-4644-9. Epub 2018 May 19.

ReferenceCitation: Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Eligibility varies among the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials: implications for the general type 2 diabetes US population. Am J Manag Care. 2018 Apr;24(8 Suppl):S138-S145.

ReferenceCitation: Inzucchi SE, Zinman B, Fitchett D, Wanner C, Ferrannini E, Schumacher M, Schmoor C, Ohneberg K, Johansen OE, George JT, Hantel S, Bluhmki E, Lachin JM. How Does Empagliflozin Reduce Cardiovascular Mortality? Insights From a Mediation Analysis of the EMPA-REG OUTCOME Trial. Diabetes Care. 2018 Feb;41(2):356-363. doi: 10.2337/dc17-1096. Epub 2017 Dec 4.

ReferenceCitation: Wanner C, Lachin JM, Inzucchi SE, Fitchett D, Mattheus M, George J, Woerle HJ, Broedl UC, von Eynatten M, Zinman B; EMPA-REG OUTCOME Investigators. Empagliflozin and Clinical Outcomes in Patients With Type 2 Diabetes Mellitus, Established Cardiovascular Disease, and Chronic Kidney Disease. Circulation. 2018 Jan 9;137(2):119-129. doi: 10.1161/CIRCULATIONAHA.117.028268. Epub 2017 Sep 13.

ReferenceCitation: Cherney DZI, Zinman B, Inzucchi SE, Koitka-Weber A, Mattheus M, von Eynatten M, Wanner C. Effects of empagliflozin on the urinary albumin-to-creatinine ratio in patients with type 2 diabetes and established cardiovascular disease: an exploratory analysis from the EMPA-REG OUTCOME randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2017 Aug;5(8):610-621. doi: 10.1016/S2213-8587(17)30182-1. Epub 2017 Jun 27.

ReferenceCitation: Zinman B, Inzucchi SE, Lachin JM, Wanner C, Fitchett D, Kohler S, Mattheus M, Woerle HJ, Broedl UC, Johansen OE, Albers GW, Diener HC; EMPA-REG OUTCOME Investigators (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients). Empagliflozin and Cerebrovascular Events in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk. Stroke. 2017 May;48(5):1218-1225. doi: 10.1161/STROKEAHA.116.015756. Epub 2017 Apr 6.

repository_institution: Conselleria de Salut i Consum del Govern de les Illes Balears - Docusalut

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docusalut.com

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ReferenceCitation: Wanner C, Inzucchi SE, Lachin JM, Fitchett D, von Eynatten M, Mattheus M, Johansen OE, Woerle HJ, Broedl UC, Zinman B; EMPA-REG OUTCOME Investigators. Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):323-34. doi: 10.1056/NEJMoa1515920. Epub 2016 Jun 14.

ReferenceCitation: Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.

ReferenceCitation: Zinman B, Inzucchi SE, Lachin JM, Wanner C, Ferrari R, Fitchett D, Bluhmki E, Hantel S, Kempthorne-Rawson J, Newman J, Johansen OE, Woerle HJ, Broedl UC. Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME). Cardiovasc Diabetol. 2014 Jun 19;13:102. doi: 10.1186/1475-2840-13-102.

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localhost
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sponsor_collaborators:
Boehringer Ingelheim
Eli Lilly and Company

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title: A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk

location_country:
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Croatia
Canada
France
Czech Republic
Colombia
Portugal
Hungary
Hong Kong
Denmark
United States
Sri Lanka
Ukraine
Indonesia
India
Romania
Belgium
Malaysia
Peru
Estonia
Philippines
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Georgia
Russian Federation
Israel


acronym: CheckMate 9LA

lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease

ReferenceCitation: Paz-Ares L, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, Richardet E, Bennouna J, Felip E, Juan-Vidal O, Alexandru A, Sakai H, Lingua A, Salman P, Souquet PJ, De Marchi P, Martin C, Perol M, Scherpereel A, Lu S, John T, Carbone DP, Meadows-Shropshire S, Agrawal S, Oukessou A, Yan J, Reck M. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):198-211. doi: 10.1016/S1470-2045(20)30641-0. Epub 2021 Jan 18. Erratum In: Lancet Oncol. 2021 Mar;22(3):e92.

oa_host_type: closed

location_facility: University of Wisconsin Carbone Cancer Center

title: A Phase 3, Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Chile
Canada
France
United States
Romania
Belgium
China
Italy
United Kingdom
Mexico
Spain
Russian Federation


summary: The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure.

location_facility: Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica

location_facility: Adana Ac?badem Hospital Oncology Department

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Ege University Medical Faculty; Chest Diseases

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Centre Georges François Leclerc; Service Pharmacie, Bp 77980

location_facility: Chao Family Comprehensive Cancer Center; UC Irvine Medical Center

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Queen Mary Hospital; Dept. of Clinical Oncology

location_facility: Istanbul Uni Capa Medical Faculty; Inst. of Oncology

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: Queen Elizabeth Hospital Department of Clinical Oncology

status: Recruiting

title: A Multicenter, International, Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

design_allocation: Non-Randomized

location_country:
Italy
Poland
Hong Kong
United States
China
Korea, Republic of
Spain
Turkey
Russian Federation
France