title: Prospective, Single Arm, Multi-centre, Observational Registry to Further Validate Safety and Efficacy of the Ultimaster Des System in Unselected Patients Representing Everyday Clinical Practice

acronym: e-Ultimaster

summary: The e-Ultimaster will further validate the safety and efficacy of Ultimaster DES system in unselected patients representing everyday clinical practice. Also the study will assess the impact of non-compliance with dual antiplatelet therapy, one month after stent implementation (frequently observed in every day clinical practice), on stent thrombosis.

status: Unknown status

lead_sponsor: Terumo Europe N.V.

location_country:
Armenia
Jordan
North Macedonia
Kazakhstan
Malaysia
Romania
Belgium
Oman
Iceland
Ukraine
India
Morocco
Spain
France
Japan
Lithuania
Poland
Kuwait
Slovakia
Thailand
Argentina
Uzbekistan
Indonesia
Colombia
South Africa
Chile
Sweden
United Arab Emirates
Saudi Arabia
Switzerland
Netherlands
Vietnam
Bulgaria
Hungary
Ireland
Portugal
United Kingdom
Austria
Brazil
Serbia
Lebanon
Mexico
Czechia
Bangladesh
Georgia
Israel
Tunisia
Egypt
Belarus
Estonia

location_facility: Hospital General Universitario de Burgos

location_facility: Clinica Hospital San Jose de Navojoa SA de CV

location_facility: S.P.M.C. of Pediatric Cardiology and Cardiac Surgery

location_facility: Polyclinique El Bassatine_Dr. Ridha Ennouri

location_facility: Hospital Clínico Lozano Blesa de Zaragoza

location_facility: G. Kuppuswamy Naidu Memorial Hospital (GKNM), Coimbatore

location_facility: Saitama Cardiovascular and Respiratory Center

location_facility: Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego

location_facility: Strazhesko Institute of Cardiology (National Scientific Centre)

location_facility: NAMS Amosov | X-Ray diagnostics and invasive cardiology department

location_facility: Markusovszky University Teaching Hospital

location_facility: HRH Princess Maha Chakri Sirindhorn Medical Center (Nakornayok)

location_facility: Landspitali National University hospital

location_facility: Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

location_facility: Hanusch Krankenhaus der Wiener Gebietskrankenkasse

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Polyclinique El bassatine_Dr. Mohamed Najeh Abid

location_facility: Dr. Wahidin Sudirohusodo General Hospital

location_facility: Saiseikai Yokohama City Eastern Hospital

location_facility: HRH Princess Maha Chakri Siridhorn Medical Center

location_facility: National Heart Foundation Hospital and Research Institute

location_facility: Cardiology Clinic, Clinical Centre of Serbia

location_facility: Hopital privé St Martin Pessac (DR Levy)

location_facility: National Scientific Medical Research Center JSC

location_facility: OLVZ Aalst, Onze Lieve Vrouw Ziekenhuis vzw-Campus Aalst

location_facility: Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego w Poznaniu

location_facility: Yerevan State medical University Hospital

location_facility: Krankenanstalt Rudolfstiftung der Stadt Wien

location_facility: NAMS Amosov | Emergency Endovascular Surgery department

location_facility: Institut Arnault Tzanck St Laurent du Var

location_facility: Institute of cardiovascular diseases Vojvodina

location_facility: Dr JCW Badenhorst - Netcare Unitas Hospital

location_facility: Hospital Universitario Lucus Augusti (HULA)

location_facility: City clinic University Multi-Profile Hospital for Acute Care,Sofia

location_facility: Specialized Cardiology Hospital for Active Treatment

location_facility: Hospital Marqués de Valdecilla, Santander

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Clinique Générale et Cardiovasculaire de Tunis_Dr. Saloua TRABELSI

location_facility: Max Super Speciality Hospital, Saket, Delhi

location_facility: Szatmar-Szabolcs-Bereg county hospital and university teaching hospital

location_facility: Government institution Regional centre of cardiac and vessel disease

location_facility: Clinique St Augustin Bordeaux-Centre d'exploration-chirurgie

location_facility: Universitario central de Asturias (Oviedo)

location_facility: Complexo Hospitalario Universitario A Coruña (CHUAC)

location_facility: Hosp Universitario de Gran Canaria Dr. Negrin

location_facility: Instituto Cardiologico Hospital Campo Grande (Valladolid)

location_facility: Medical University Clinic West Kazakhstan

location_facility: Polyclinique El Bassatine SFAX_Dr. Sami Fourati

location_facility: Hospital e Maternidade Dr. Christóvão da Gama

location_facility: City General Hospital 8th September Skopje

location_facility: Dr Hussien Heshmat - As Salam International Hospital

location_facility: Prince Abdullah Bin Abdulaziz Cardiac Center

location_facility: Nottingham University Hospitals - Queen's Medical Centre

location_facility: Clinique Général et Cardiovasculaire de Tunis_Dr. Saloua Trabelsi

location_facility: National Cardiovascular Center Harapan Kita

location_facility: H.J. Doshi Ghatkopar Hindusabha Hospital

location_facility: Clinique Hannibal Lac 2_Dr. Mohamed Drissa

location_facility: Clinical Center of Cardiac Surgery and Transplantation

location_facility: Groupe Hospitalier de la Rochelle Ré Aunis

location_facility: National Institute of Surgery and Transplantology NAMS

location_facility: Clinique Générale et Cardiovasculaire de Tunis_Dr. Sami Bouziri

location_facility: Le Confluent Nouvelles Cliniques Nantaises

location_facility: Stredodlovensky Ustav Srdcovych A Cievnych Chorob

location_facility: Polyclinique Bassatine Cite gardin Sfax_Dr. Zeineb Grati Guermazi

location_facility: National Institute of Cardiovascular Surgery NAMS

location_facility: Universitario Santa Lucia (Hospital Nostra Señora Rossell) (Cartagena)

status_simplified: Unknown


type: Other Identifier

title: AXITINIB IN ADVANCED / METASTATIC RENAL CELL CARCINOMA - A NON-INTERVENTIONAL STUDY OF REAL WORLD TREATMENT OUTCOMES IN PATIENTS RECEIVING 2ND LINE AXITINIB AFTER 1ST LINE SUNITINIB (ADONIS)

acronym: ADONIS

summary: This is an international, multi-centre, prospective (partly retrospective), observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated with sunitinib in first line and/or receiving axitinib in second line post sunitinib. The study is designed to enroll approximately 750 patients over the course of an enrollment period of approximately 36 months.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Other

enrollment_type: Actual

ipd_sharing: No

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:
Italy
Austria
Netherlands
France
Greece
Belgium
Spain
United Kingdom

location_facility: Cl Armoricaine Radiologie / Radiotherapie

location_facility: Istituto Nazionale Tumori, Oncologia Medica B

location_facility: Institut Sainte Catherine, Department Oncologie, Medecine Interene

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: C.H.G. Antoine Gayraud, Medecine Interne

location_facility: General Hospital of Chest Diseases of Athens "Sotiria"

location_facility: AKH - Universitaetsklinik fuer Innere Medizin I

location_facility: Krankenhaus der Barmherzigen Schwestern Linz Abteilung fuer Urologie

location_facility: AKH-Universitat Klinik fur Innere Medizin I

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre d'Oncologie et de Radiotherapie du pays Basque

location_facility: Centre Hospitalier Lyon Sud - Service d oncologie medicale

location_facility: Centre Hospitalier De Bourg En Bresse - Hopital Fleyriat

location_facility: Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta

location_facility: Hopital de Hautepierre-Service Oncologie at Hematologie

location_facility: Groupe Hospitalier Intercommunal le Raincy Montfermeil

location_facility: Divisione di Oncologia, AORN Antonio Cardarelli

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

location_facility: Universitasklinik für Urologie und Andrologie

location_facility: Centro Sanitario Hospital Universitario y Politecnico La Fe

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Hospital General Universitario de Alicante

location_facility: Centre Rene Gauducheau - Service Oncologie Medicale

location_facility: H. U. de Vigo- Hospital Álvaro Cunqueiro/Servicio de Oncologia Medica

location_facility: Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera

location_facility: Divisione di Oncologia Medica, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Hopital Jean BERNARD - Tours - 7eme etage

location_facility: Royal Marsden Hospital, Royal Marsden NHS Foundation Trust

location_facility: Centre Antoine Lacassagne, Service d'Oncologie

location_facility: Algemeen Ziekenhuis Sint-Lucas, Dienst Oncologie

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease

summary: The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD. Published studies which assessed the use of an 'open' triple therapy (use of Inhaled Corticosteroid [ICS]/ Long-acting Muscarinic Receptor Antagonists [LAMA])/ Long Acting Beta-Agonist [LABA] delivered via multiple inhalers) in moderate-severe COPD patients, reported improvements in lung function, Health Related Quality of Life (HRQoL), hospitalization rates and rescue medication use, compared to dual therapy (ICS/LABA) or LAMA alone. These studies have also shown similar safety profile with dual or monotherapy doses for periods of up to one year. Given the clinical experience with FF, UMEC and VI, and that the associated risks with these compounds are anticipated from their known pharmacology, the potential benefit of a new therapy option in patients with moderate to severe COPD supports the further development of the closed triple combination (delivered via one inhaler). In the current study subjects meeting all inclusion/exclusion criteria will complete 2-week run-in period; 52 week treatment period and a 1-week safety follow-up period. Eligible subjects will be randomized to one of the following double-blind treatment groups FF/UMEC/VI 100 micrograms (mcg)/62.5 mcg/25 mcg once daily (QD), FF/VI 100 mcg/25 mcg QD, or UMEC/VI 62.5 mcg/25 mcg QD

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Bafadhel M, Barnes N, Bourke SC, Compton C, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Hartley B, Jones CE, Lange P, Lettis S, Lipson DA, Lomas DA, Martin N, Martinez FJ, Wise R, Singh D. A single blood eosinophil count measurement is as good as two for prediction of ICS treatment response in the IMPACT trial. Eur Respir J. 2021 Sep 23;58(3). pii: 2004522. doi: 10.1183/13993003.04522-2020. Print 2021 Sep.

family: Bafadhel

full_name: Mona Bafadhel

given: Mona

sequence: first

family: Barnes

full_name: Neil Barnes

given: Neil

sequence: additional

family: Bourke

full_name: Stephen C. Bourke

given: Stephen C.

family: Compton

full_name: Chris Compton

given: Chris

family: Criner

full_name: Gerard J. Criner

given: Gerard J.

family: Dransfield

full_name: Mark T. Dransfield

given: Mark T.

family: Halpin

full_name: David M.G. Halpin

given: David M.G.

family: Han

full_name: MeiLan K. Han

given: MeiLan K.

family: Hartley

full_name: Benjamin Hartley

given: Benjamin

family: Jones

full_name: C. Elaine Jones

given: C. Elaine

family: Lange

full_name: Peter Lange

given: Peter

family: Lettis

full_name: Sally Lettis

given: Sally

family: Lipson

full_name: David A. Lipson

given: David A.

family: Lomas

full_name: David A. Lomas

family: Martin

full_name: Neil Martin

family: Martinez

full_name: Fernando J. Martinez

given: Fernando J.

family: Wise

full_name: Robert Wise

given: Robert

family: Singh

full_name: Dave Singh

given: Dave

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Respiratory Journal

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

ReferenceCitation: Singh D, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lange P, Lettis S, Lipson DA, Mannino D, Martin N, Martinez FJ, Miller BE, Wise R, Zhu CQ, Lomas D. InforMing the PAthway of COPD Treatment (IMPACT) trial: fibrinogen levels predict risk of moderate or severe exacerbations. Respir Res. 2021 Apr 28;22(1):130. doi: 10.1186/s12931-021-01706-y.

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

repository_institution: University College London - UCL Discovery

repositories:
PubMed Central
UCL Discovery
uknowledge.uky.edu

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Halpin DMG, Criner GJ, Dransfield MT, Han MK, Hartley B, Harvey C, Jones CE, Kato M, Lange P, Lettis S, Lomas DA, Martinez FJ, Martin N, Singh D, Wise R, Zheng J, Lipson DA. Triple Versus Dual Combination Therapy in Chronic Obstructive Pulmonary Disease in Asian Countries: Analysis of the IMPACT Trial. Pulm Ther. 2021 Jun;7(1):101-118. doi: 10.1007/s41030-020-00136-3. Epub 2020 Nov 17.

ReferenceCitation: Bourdin A, Criner G, Devouassoux G, Dransfield M, Halpin DMG, Han MK, Jones CE, Kalhan R, Lange P, Lettis S, Lipson DA, Lomas DA, Echave-Sustaeta María-Tomé JM, Martin N, Martinez FJ, Quasny H, Sail L, Siler TM, Singh D, Thomashow B, Watz H, Wise R, Hanania NA. InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients With COPD: Analysis of the Western Europe and North America Regions. Chronic Obstr Pulm Dis. 2021 Jan;8(1). doi: 10.15326/jcopdf.2020.0158.

journal_name: Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation

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

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

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

ReferenceCitation: Zheng J, Zhong N, Wang C, Wei LP, Zhou XD, Zhao L, Dong Yuan Y, He B, Wu B, Du X, Song J, Lipson DA. Single inhaler triple therapy (FF/UMEC/VI) versus FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the China cohort in the IMPACT trial. Curr Med Res Opin. 2021 Jan;37(1):145-155. doi: 10.1080/03007995.2020.1844646. Epub 2020 Dec 7.

name: State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China

name: Xinqiao Hospital, Third Military Medical University, Chongqing, China

name: Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, China

name: Xinan Hospital, Third Military Medical University, Chongqing, China

name: Shengjing Hospital of China Medical University, Shenyang, China

name: Respiratory Department, The Second Hospital of Hebei Medical University, Shijazhuang, China

name: Peking University Third Hospital, Beijing, China

name: Affiliated Hospital, Guangdong Medical University, Zhanjiang, China

name: Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

ReferenceCitation: Marín JM, Mateos L, Roldán J, Echave-Sustaeta JM, Pascual-Guardia S, Pardo MV, Velasco B, Jones CE, Kilbride S, Lipson DA. Efficacy of FF/UMEC/VI compared with FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the Spain cohort in IMPACT. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620963021. doi: 10.1177/1753466620963021.

name: Servicio de Neumología, IISAragón, Hospital Universitario Miguel Servet, Zaragoza, Spain

name: CIBER Enfermedades Respiratorias, Madrid, Spain

name: Servicio de Neumología, Hospital de Mérida, Badajoz, Spain

name: Servicio de Neumología, Giromed Institute, Gerona, Spain

name: Servicio de Neumología, Hospital Universitario Quirón Salud, Madrid, Spain

name: Servicio de Neumología, Hospital del Mar-IMIM, CIBERES, UPF, BRN, Barcelona, Spain

name: Departamento Médico, España, GSK, Madrid, Spain

name: GSK, Stockley Park West, Uxbridge, Middlesex, UK

journal_name: Therapeutic Advances in Respiratory Disease

ReferenceCitation: Hanania NA, Mannino DM, Criner GJ, Dransfield MT, Han MK, Jones CE, Kilbride S, Lomas DA, Martin N, Martinez FJ, Singh D, Wise RA, Halpin DMG, Lima R, Lipson DA. Effect of Age on the Efficacy and Safety of Once-Daily Single-Inhaler Triple-Therapy Fluticasone Furoate/Umeclidinium/Vilanterol in Patients With COPD: A Post Hoc Analysis of the Informing the Pathway of COPD Treatment Trial. Chest. 2021 Mar;159(3):985-995. doi: 10.1016/j.chest.2020.09.253. Epub 2020 Oct 5.

ReferenceCitation: Tabberer M, Jones CE, Kilbride S, Halpin DMG, Lomas DA, Pascoe S, Singh D, Wise RA, Criner GJ, Lange P, Dransfield MT, Han MK, Martinez FJ, Kaisermann MC, Lipson DA. Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD: The IMPACT Study. Adv Ther. 2020 Sep;37(9):3775-3790. doi: 10.1007/s12325-020-01409-8. Epub 2020 Jul 9.

ReferenceCitation: Han MK, Criner GJ, Dransfield MT, Halpin DMG, Jones CE, Kilbride S, Lange P, Lettis S, Lipson DA, Lomas DA, Martin N, Wise RA, Singh D, Martinez FJ. The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study. A Randomized, Double-Blind, Multicenter Clinical Trial. Am J Respir Crit Care Med. 2020 Nov 1;202(9):1237-1243. doi: 10.1164/rccm.201912-2478OC.

name: Division of Pulmonary and Critical Care, University of Michigan, Ann Arbor, Michigan

name: Pulmonary and Critical Care Medicine, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania

name: Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama

name: University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, United Kingdom

name: Development, Research and Development, and

name: Clinical Sciences, GlaxoSmithKline, Collegeville, Pennsylvania

name: Biostatistics, GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, United Kingdom

name: Medical Department, Pulmonary Section, Herlev–Gentofte Hospital, Herlev, Denmark

name: Pulmonary, Allergy and Critical Care Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

name: UCL Respiratory, University College London, London, United Kingdom

name: Global Medical Affairs, GlaxoSmithKline, Brentford, Middlesex, United Kingdom

name: Institute for Lung Health, University of Leicester, Leicester, United Kingdom

name: Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, United Kingdom; and

name: New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York

journal_name: American Journal of Respiratory and Critical Care Medicine

ReferenceCitation: Day NC, Kumar S, Criner G, Dransfield M, Halpin DMG, Han MK, Jones CE, Kaisermann MC, Kilbride S, Lange P, Lomas DA, Martin N, Martinez FJ, Singh D, Wise R, Lipson DA. Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial. Respir Res. 2020 Jun 5;21(1):139. doi: 10.1186/s12931-020-01398-w.

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

repositories:
PubMed Central
Pure (Denmark)
UCL Discovery

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

ReferenceCitation: Bogart MR, Hopson SD, Shih HC, Stanford RH, Coutinho AD. COPD exacerbation costs in the IMPACT study: a within-trial analysis. Am J Manag Care. 2020 May 1;26(5):e150-e154. doi: 10.37765/ajmc.2020.43157.

publisher: Managed Care and Healthcare Communications, LLC

publisher_dissemination: Managed Care and Healthcare Communications, LLC

publisher_group: Managed Care and Healthcare Communications, LLC

publisher_normalized: Managed Care and Healthcare Communications, LLC

title: COPD exacerbation costs in the IMPACT study: a within-trial analysis

ReferenceCitation: Halpin DMG, Dransfield MT, Han MK, Jones CE, Kilbride S, Lange P, Lipson DA, Lomas DA, Martinez FJ, Pascoe S, Singh D, Wise R, Criner GJ. The effect of exacerbation history on outcomes in the IMPACT trial. Eur Respir J. 2020 May 21;55(5). pii: 1901921. doi: 10.1183/13993003.01921-2019. Print 2020 May. Erratum in: Eur Respir J. 2020 Jun 18;55(6):.

title: The effect of exacerbation history on outcomes in the IMPACT trial

ReferenceCitation: Lipson DA, Crim C, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Lettis S, Manchester P, Martin N, Midwinter D, Morris A, Pascoe SJ, Singh D, Wise RA, Martinez FJ. Reduction in All-Cause Mortality with Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2020 Jun 15;201(12):1508-1516. doi: 10.1164/rccm.201911-2207OC.

name: Clinical Sciences, GlaxoSmithKline, Research Triangle Park, North Carolina

name: Pulmonary and Critical Care Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania

name: University of Michigan, Pulmonary and Critical Care, Ann Arbor, Michigan

name: Biostatistics, GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom

name: Section of Epidemiology, Department of Public Health, University of Copenhagen, Copenhagen, Denmark

name: Global Clinical Science and Delivery, GlaxoSmithKline, Collegeville, Pennsylvania

name: Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland; and

name: New York–Presbyterian Hospital/Weill Cornell Medical Center, New York, New York

ReferenceCitation: Ismaila AS, Risebrough N, Schroeder M, Shah D, Martin A, Goodall EC, Ndirangu K, Criner G, Dransfield M, Halpin DM, Han MK, Lomas DA. Cost-Effectiveness Of Once-Daily Single-Inhaler Triple Therapy In COPD: The IMPACT Trial. Int J Chron Obstruct Pulmon Dis. 2019 Nov 29;14:2681-2695. doi: 10.2147/COPD.S216072. eCollection 2019.

journal_name: International Journal of Chronic Obstructive Pulmonary Disease

repository_institution: Royal Devon and Exeter - Royal Devon and Exeter Research Repository

repositories:
PubMed Central
UCL Discovery
rde.dspace-express.com

repositories_institution: Royal Devon and Exeter - Royal Devon and Exeter Research Repository

ReferenceCitation: Mehta R, Farrell C, Hayes S, Birk R, Okour M, Lipson DA. Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2020 Jan;59(1):67-79. doi: 10.1007/s40262-019-00794-w.

ReferenceCitation: Pascoe S, Barnes N, Brusselle G, Compton C, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Hartley B, Lange P, Lettis S, Lipson DA, Lomas DA, Martinez FJ, Papi A, Roche N, van der Valk RJP, Wise R, Singh D. Blood eosinophils and treatment response with triple and dual combination therapy in chronic obstructive pulmonary disease: analysis of the IMPACT trial. Lancet Respir Med. 2019 Sep;7(9):745-756. doi: 10.1016/S2213-2600(19)30190-0. Epub 2019 Jul 4.

ReferenceCitation: Lipson DA, Barnhart F, Brealey N, Brooks J, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Martinez FJ, Singh D, Tabberer M, Wise RA, Pascoe SJ; IMPACT Investigators. Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD. N Engl J Med. 2018 May 3;378(18):1671-1680. doi: 10.1056/NEJMoa1713901. Epub 2018 Apr 18.

name: From GlaxoSmithKline, Collegeville (D.A. Lipson, J.B., S.J.P.), and the Perelman School of Medicine, University of Pennsylvania (D.A. Lipson), and Lewis Katz School of Medicine at Temple University (G.J.C.), Philadelphia — all in Pennsylvania; GlaxoSmithKline, Research Triangle Park, NC (F.B., C.E.J.); GlaxoSmithKline, Stockley Park West, Uxbridge (N.B., N.C.D., S.K., M.T.), the Department of Respiratory Medicine, Royal Devon and Exeter Hospital, Exeter (D.M.G.H.), UCL Respiratory, University College...

repository_institution: The University of Manchester - Research Explorer

repositories_institution: The University of Manchester - Research Explorer

title: Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD

ReferenceCitation: Pascoe SJ, Lipson DA, Locantore N, Barnacle H, Brealey N, Mohindra R, Dransfield MT, Pavord I, Barnes N. A phase III randomised controlled trial of single-dose triple therapy in COPD: the IMPACT protocol. Eur Respir J. 2016 Aug;48(2):320-30. doi: 10.1183/13993003.02165-2015. Epub 2016 Jul 13.

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_institution: University of Oxford - Oxford University Research Archive (ORA)

location_country:
Peru
Finland
Romania
Australia
Belgium
Russian Federation
Denmark
Ukraine
France
Japan
Poland
Thailand
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Philippines
Vietnam
Singapore
Puerto Rico
China
Germany
United States
United Kingdom
Austria
Brazil
Czechia
Israel
New Zealand
Spain
Turkey


type: EudraCT Number

type: Registry Identifier

title: Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as Add on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

acronym: SUSTAIN™ 4

summary: This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.

ReferenceType: background

ReferenceCitation: Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA(1C) ≥1.0% AND WEIGHT ≥5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13.

ReferenceType: result

ReferenceCitation: Aroda VR, Bain SC, Cariou B, Piletič M, Rose L, Axelsen M, Rowe E, DeVries JH. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial. Lancet Diabetes Endocrinol. 2017 May;5(5):355-366. doi: 10.1016/S2213-8587(17)30085-2. Epub 2017 Mar 23.

family: Aroda

full_name: Vanita R Aroda

given: Vanita R

family: Bain

full_name: Stephen C Bain

given: Stephen C

family: Cariou

full_name: Bertrand Cariou

given: Bertrand

family: Piletič

full_name: Milivoj Piletič

given: Milivoj

family: Rose

full_name: Ludger Rose

given: Ludger

family: Axelsen

full_name: Mads Axelsen

given: Mads

family: Rowe

full_name: Everton Rowe

given: Everton

family: DeVries

full_name: J Hans DeVries

given: J Hans

journal_name: The Lancet Diabetes & Endocrinology

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: Swansea University - Cronfa

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Kapitza C, Dahl K, Jacobsen JB, Axelsen MB, Flint A. Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. Diabetologia. 2017 Aug;60(8):1390-1399. doi: 10.1007/s00125-017-4289-0. Epub 2017 May 19.

family: Kapitza

full_name: Christoph Kapitza

given: Christoph

family: Dahl

full_name: Kirsten Dahl

given: Kirsten

family: Jacobsen

full_name: Jacob B. Jacobsen

given: Jacob B.

full_name: Mads B. Axelsen

given: Mads B.

family: Flint

full_name: Anne Flint

given: Anne

journal_name: Diabetologia

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

ReferenceCitation: Warren M, Chaykin L, Trachtenbarg D, Nayak G, Wijayasinghe N, Cariou B. Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2291-2297. doi: 10.1111/dom.13331. Epub 2018 Jun 7.

name: Physicians East; Greenville North Carolina

name: University of Illinois College of Medicine at Peoria; Peoria Illinois

name: L'Institut du Thorax, Department of Endocrinology; CHU de Nantes; Nantes France

ReferenceCitation: Ahrén B, Atkin SL, Charpentier G, Warren ML, Wilding JPH, Birch S, Holst AG, Leiter LA. Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2210-2219. doi: 10.1111/dom.13353. Epub 2018 Jun 12.

name: Department of Clinical Sciences, Lund University; Lund Sweden

name: Weill Cornell Medical College Qatar; Doha Qatar

name: Department of Diabetes and Endocrinology, Centre Hospitalier Régional Gilles de Corbeil; Évry France

name: Endocrinology and Metabolism, Physicians East; Greenville North Carolina

name: Institute of Ageing and Chronic Disease, University of Liverpool; Liverpool UK

name: Li Ka Shing Knowledge Institute; St. Michael's Hospital, University of Toronto; Toronto Canada

ReferenceCitation: DeVries JH, Desouza C, Bellary S, Unger J, Hansen OKH, Zacho J, Woo V. Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. Diabetes Obes Metab. 2018 Oct;20(10):2426-2434. doi: 10.1111/dom.13396. Epub 2018 Jul 9.

name: Department of Endocrinology; Academic Medical Centre; Amsterdam The Netherlands

name: Profil Institute for Metabolic Research; Neuss Germany

name: Division of Diabetes Endocrinology & Metabolism; University of Nebraska Medical Center; Omaha Nebraska

name: School of Life and Health Sciences; Aston University; Birmingham UK

name: Director, Metabolic Studies; Catalina Research Institute; Chino, California

name: Section of Endocrinology and Metabolism, Health Sciences Centre; University of Manitoba; Winnipeg Canada

repository_institution: Aston University - Aston Publications Explorer

ReferenceCitation: Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jódar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4. Review.

repository_institution: University of Leicester - Leicester Research Archive

title: Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1–7 trials

ReferenceCitation: Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.

repositories:
PubMed Central
cronfa.swan.ac.uk
localhost

repositories_institution:
Swansea University - Cronfa
University of Toronto - TSpace

ReferenceCitation: Capehorn M, Ghani Y, Hindsberger C, Johansen P, Jódar E. Once-Weekly Semaglutide Reduces HbA(1c) and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10. Diabetes Ther. 2020 May;11(5):1061-1075. doi: 10.1007/s13300-020-00796-z. Epub 2020 Mar 19.

title: Once-Weekly Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2–4 and 10

ReferenceCitation: Husain M, Bain SC, Jeppesen OK, Lingvay I, Sørrig R, Treppendahl MB, Vilsbøll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.

name: Ted Rogers Centre for Heart ResearchToronto General Hospital Research Institute Toronto Canada

name: Swansea University Medical School, Diabetes Research Unit Cymru Swansea UK

name: UT Southwestern Medical Center, Internal Medicine and Population and Data Sciences Dallas Texas

name: Steno Diabetes Center CopenhagenGentofte Hospital, University of Copenhagen Copenhagen Denmark

repositories_institution:
PubMed Central - Europe PMC
Swansea University - Cronfa

ReferenceCitation: DeSouza C, Cariou B, Garg S, Lausvig N, Navarria A, Fonseca V. Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials. J Clin Endocrinol Metab. 2020 Feb 1;105(2). pii: dgz072. doi: 10.1210/clinem/dgz072.

name: University of Nebraska Medical Center, Omaha, NE, US

name: L’Institut du Thorax, Department of Endocrinology, CHU Nantes, Nantes, France

name: Barbara Davis Center for Diabetes, University of Colorado Denver, Denver, CO, US

name: Tulane University Health Sciences Center, New Orleans, LA, US

journal_name: The Journal of Clinical Endocrinology & Metabolism

repository_institution: CERN European Organization for Nuclear Research - Zenodo

ReferenceCitation: Jendle J, Birkenfeld AL, Polonsky WH, Silver R, Uusinarkaus K, Hansen T, Håkan-Bloch J, Tadayon S, Davies MJ. Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials. Diabetes Obes Metab. 2019 Oct;21(10):2315-2326. doi: 10.1111/dom.13816. Epub 2019 Jul 12.

name: Diabetes Endocrinology and Metabolism Research Center, School of Medical Sciences, Örebro University Örebro Sweden

name: Department of Medicine IIICarl Gustav Carus University Hospital, Technische Universität Dresden Dresden Germany

name: Paul Langerhans Institute Dresden, Helmholtz Center Munich at Technische Universität Dresden Dresden Germany

name: Behavioral Diabetes Institute, University of California San Diego San Diego California

name: Southern New Hampshire Diabetes and Endocrinology Nashua New Hampshire

name: DaVita Medical GroupUniversity of Colorado School of Medicine Colorado Springs Colorado

name: Diabetes Research Centre, University of Leicester Leicester UK

title: Improved treatment satisfaction in patients with type 2 diabetes treated with once‐weekly semaglutide in the SUSTAIN trials

location_country:
United States
South Africa
India
United Kingdom
Mexico
Netherlands
North Macedonia
Croatia
France
Slovakia
Romania
Argentina
Puerto Rico
Germany
Slovenia


title: Sub-cutaneous Rituximab-miniCHOP Versus Sub-cutaneous Rituximab-miniCHOP + Lenalidomide (R2-miniCHOP) in Diffuse Large B Cell Lymphoma for Patients of 80 Years Old or More. A Multicentric Phase III Study of the LYSA Association

summary: The purpose of this study is to compare the efficacy of R2-miniCHOP (Sub-cutaneous Rituximab-miniCHOP + lenalidomide) and R-miniCHOP (Sub-cutaneous Rituximab-miniCHOP) in patients aged 80 years old or more with not previously treated cluster of differentiation antigen 20 positive (CD20+) diffuse large B-cell lymphoma as measured by the overall survival (OS).The SENIOR trial will evaluate the tolerance and efficacy of the combination of the R2-miniCHOP regimen and compare this experimental arm to the standard R-miniCHOP regimen.The statistical plan is based on the hypothesis of an increase by 15% of the 2y-OS in favor of the experimental arm, as compared to the reference arm (R-miniCHOP).

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Belgium France

location_facility: Université Catholique de Louvain Saint Luc

intervention_type: Drug


title: Phase 3B, Randomized Trail of Revlimid® (Lenalidomide) Versus Placebo Maintenance Therapy Following Melphalan Prednisone Velcade (Bortezomib) Induction Therapy In Newly Diagnosed Multiple Myeloma

acronym: ARUMM

summary:
The purpose of this study is to compare the safety and efficacy of Lenalidomide versus Placebo maintenance following melphalan, prednisone and velcade induction therapy in newly diagnosed multiple myeloma.

After the study is unblinded, subjects in treatment Arm A (Len 10 mg) will remain on study therapy at the Investigator's discretion and subjects in treatment Arm B (placebo), will be discontinued from study treatment. Subjects who discontinued from study treatment for any reason will enter the LTFU Phase.

ReferenceCitation: Ailawadhi S, Jacobus S, Sexton R, Stewart AK, Dispenzieri A, Hussein MA, Zonder JA, Crowley J, Hoering A, Barlogie B, Orlowski RZ, Rajkumar SV. Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials. Blood Cancer J. 2018 Jul 6;8(7):67. doi: 10.1038/s41408-018-0102-7.

ReferenceCitation: Dumontet C, Hulin C, Dimopoulos MA, Belch A, Dispenzieri A, Ludwig H, Rodon P, Van Droogenbroeck J, Qiu L, Cavo M, Van de Velde A, Lahuerta JJ, Allangba O, Lee JH, Boyle E, Perrot A, Moreau P, Manier S, Attal M, Roussel M, Mohty M, Mary JY, Civet A, Costa B, Tinel A, Gaston-Mathé Y, Facon T. A predictive model for risk of early grade ≥ 3 infection in patients with multiple myeloma not eligible for transplant: analysis of the FIRST trial. Leukemia. 2018 Jun;32(6):1404-1413. doi: 10.1038/s41375-018-0133-x. Epub 2018 Apr 26.

ReferenceCitation: Jain T, Sonbol MB, Firwana B, Kolla KR, Almader-Douglas D, Palmer J, Fonseca R. High-Dose Chemotherapy with Early Autologous Stem Cell Transplantation Compared to Standard Dose Chemotherapy or Delayed Transplantation in Patients with Newly Diagnosed Multiple Myeloma: A Systematic Review and Meta-Analysis. Biol Blood Marrow Transplant. 2019 Feb;25(2):239-247. doi: 10.1016/j.bbmt.2018.09.021. Epub 2018 Sep 20.

ReferenceCitation: Gambella M, Omedé P, Spada S, Muccio VE, Gilestro M, Saraci E, Grammatico S, Larocca A, Conticello C, Bernardini A, Gamberi B, Troia R, Liberati AM, Offidani M, Rocci A, Palumbo A, Cavo M, Sonneveld P, Boccadoro M, Oliva S. Minimal residual disease by flow cytometry and allelic-specific oligonucleotide real-time quantitative polymerase chain reaction in patients with myeloma receiving lenalidomide maintenance: A pooled analysis. Cancer. 2019 Mar 1;125(5):750-760. doi: 10.1002/cncr.31854. Epub 2018 Dec 18.

ReferenceCitation: Pegourie B, Karlin L, Benboubker L, Orsini-Piocelle F, Tiab M, Auger-Quittet S, Rodon P, Royer B, Leleu X, Bareau B, Cliquennois M, Fuzibet JG, Voog E, Belhadj-Merzoug K, Decaux O, Rey P, Slama B, Leyronnas C, Zarnitsky C, Boyle E, Bosson JL, Pernod G; IFM Group. Apixaban for the prevention of thromboembolism in immunomodulatory-treated myeloma patients: Myelaxat, a phase 2 pilot study. Am J Hematol. 2019 Jun;94(6):635-640. doi: 10.1002/ajh.25459. Epub 2019 Apr 1.

lead_sponsor: Celgene

location_country: Italy France Greece Belgium Spain

location_facility: Policlinico San Matteo Universita Di Pavia

location_facility: Centre Hospitalier Regional Metz-Thionville Hopital de Mercy

location_facility: Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce

location_facility: Institut Universitaire du Cancer IUCT - Oncopole

location_facility: Unità Operativa di Oncoematologia, Ospedale di Matera

location_facility: Dipartimento Medicina ed Oncologia Sperimentale - Divisione Universitaria di Ematologia Azienda Ospe

location_facility: U.O. di Ematologia e Trapianto di Midollo Osseo

location_facility: Theagenio Anticancer Hospital of Thessaloniki

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: Clinica Ematologica, A.O.U. San Martino di Genova

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Centre Hospitalier EpiCURA - Clinique Louis Caty de Baudour

location_facility: Centre Hospitalier de la Region d'Annecy

location_facility: Centre Hospitalier Sud Francilien - Site Gilles de Corbeil


title: Evaluation of an Immunomodulatory Maintenance Treatment in Patients With Metastatic Colorectal Cancer With Tumor Reduction During Induction Treatment

acronym: IMPALA

summary: The purpose of this this trial is to prove the efficacy and safety of MGN1703 as a maintenance therapy after first-line chemotherapeutic treatment of metastatic colorectal cancer.

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Mologen AG

location_country:
Italy
Austria
France
Belgium
Spain
Estonia
Germany
United Kingdom

location_facility: Ospedale Civile SS Annunziata, U.O.C. Oncologia Medica

location_facility: Universitätsklinikum Gießen und Marburg, Standort Gießen

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: St. Josef-Hospital im Katholischen Klinikum Bochum

location_facility: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Onkologie Dreiländereck - Onkologische Schwerpunktpraxis Lörrach

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: Medizinisches Versorgungszentrum Osthessen GmbH

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin

location_facility: York Teaching Hospitals NHS Fondation Trust, Research and Development department

location_facility: DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH

location_facility: Hospital Universitario Central de Asturias

location_facility: Clinique Saint Anne, Strasbourg Oncologie Liberale

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hospital Universitario Arnau de Vilanova

location_facility: Ospedale Infermi di Rimini, U.O. Oncologia

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

location_facility: Klinikum Mittelbaden Medizinische Klinik II

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hôpital Européen Georges Pompidou (HEGP)

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

location_facility: Medizinisches Versorgungszentrum Ärzteforum Seestrasse

location_facility: HELIOS Klinikum Wuppertal Medizinische Klinik I


ReferenceCitation: Heerspink HJL, Oshima M, Zhang H, Li J, Agarwal R, Capuano G, Charytan DM, Craig J, de Zeeuw D, Di Tanna GL, Levin A, Neal B, Perkovic V, Wheeler DC, Yavin Y, Jardine MJ. Canagliflozin and Kidney-Related Adverse Events in Type 2 Diabetes and CKD: Findings From the Randomized CREDENCE Trial. Am J Kidney Dis. 2021 May 23. pii: S0272-6386(21)00626-0. doi: 10.1053/j.ajkd.2021.05.005. [Epub ahead of print]

family: Heerspink

full_name: Hiddo J.L. Heerspink

given: Hiddo J.L.

family: Oshima

full_name: Megumi Oshima

given: Megumi

family: Zhang

full_name: Hong Zhang

given: Hong

family: Li

full_name: Jingwei Li

given: Jingwei

family: Agarwal

full_name: Rajiv Agarwal

given: Rajiv

family: Capuano

full_name: George Capuano

given: George

family: Charytan

full_name: David M. Charytan

given: David M.

family: Craig

full_name: Jagriti Craig

given: Jagriti

family: de Zeeuw

full_name: Dick de Zeeuw

given: Dick

family: Di Tanna

full_name: Gian Luca Di Tanna

given: Gian Luca

family: Levin

full_name: Adeera Levin

given: Adeera

family: Neal

full_name: Bruce Neal

given: Bruce

family: Perkovic

full_name: Vlado Perkovic

given: Vlado

family: Wheeler

full_name: David C. Wheeler

given: David C.

family: Yavin

full_name: Yshai Yavin

given: Yshai

family: Jardine

full_name: Meg J. Jardine

given: Meg J.

journal_name: American Journal of Kidney Diseases

ReferenceCitation: Zhou Z, Jardine MJ, Li Q, Neuen BL, Cannon CP, de Zeeuw D, Edwards R, Levin A, Mahaffey KW, Perkovic V, Neal B, Lindley RI; CREDENCE Trial Investigators*. Effect of SGLT2 Inhibitors on Stroke and Atrial Fibrillation in Diabetic Kidney Disease: Results From the CREDENCE Trial and Meta-Analysis. Stroke. 2021 May;52(5):1545-1556. doi: 10.1161/STROKEAHA.120.031623. Epub 2021 Apr 20.

name: The George Institute for Global Health, UNSW Sydney, Australia (Z.Z., M.J.J., Q.L., B.L.N., V.P., B.N.).

name: Department of Radiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China (Z.Z.).

family: Zhou

full_name: Zien Zhou

given: Zien

name: Concord Repatriation General Hospital, Sydney, Australia (M.J.J.).

full_name: Qiang Li

given: Qiang

family: Neuen

full_name: Brendon L. Neuen

given: Brendon L.

name: Cardiovascular Division, Brigham and Women’s Hospital and Baim Institute for Clinical Research, Boston, MA (C.P.C.).

family: Cannon

full_name: Christopher P. Cannon

given: Christopher P.

name: Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, the Netherlands (D.d.Z.).

name: Janssen Research & Development, LLC, Raritan, NJ (R.E.).

family: Edwards

name: Division of Nephrology, University of British Columbia, Vancouver, BC, Canada (A.L.).

name: Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, CA (K.W.M.).

name: Royal North Shore Hospital, Sydney, Australia (V.P.).

name: Charles Perkins Centre, University of Sydney, Australia (B.N.).

name: Imperial College London, London, United Kingdom (B.N.).

name: Westmead Applied Research Centre, University of Sydney, Sydney, Australia (R.I.L.).

name: The George Institute for Global Health, Sydney, Australia (R.I.L.).

repository_normalized: University of Melbourne - Minerva Access

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

repositories: University of Melbourne - Minerva Access

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Jardine M, Zhou Z, Lambers Heerspink HJ, Hockham C, Li Q, Agarwal R, Bakris GL, Cannon CP, Charytan DM, Greene T, Levin A, Li JW, Neuen BL, Neal B, Oh R, Oshima M, Pollock C, Wheeler DC, de Zeeuw D, Zhang H, Zinman B, Mahaffey KW, Perkovic V. Kidney, Cardiovascular, and Safety Outcomes of Canagliflozin according to Baseline Albuminuria: A CREDENCE Secondary Analysis. Clin J Am Soc Nephrol. 2021 Mar 8;16(3):384-395. doi: 10.2215/CJN.15260920. Epub 2021 Feb 22.

journal_name: Clinical Journal of the American Society of Nephrology

ReferenceCitation: Ye N, Jardine MJ, Oshima M, Hockham C, Heerspink HJL, Agarwal R, Bakris G, Schutte AE, Arnott C, Chang TI, Górriz JL, Cannon CP, Charytan DM, de Zeeuw D, Levin A, Mahaffey KW, Neal B, Pollock C, Wheeler DC, Luca Di Tanna G, Cheng H, Perkovic V, Neuen BL. Blood Pressure Effects of Canagliflozin and Clinical Outcomes in Type 2 Diabetes and Chronic Kidney Disease: Insights From the CREDENCE Trial. Circulation. 2021 May 4;143(18):1735-1749. doi: 10.1161/CIRCULATIONAHA.120.048740. Epub 2021 Feb 8.

name: The George Institute for Global Health (N.Y., M.J.J., M.O., C.H., A.E.S., C.A., B.N., D.C.W., G.L.D.T., V.P., B.L.N.), University of New South Wales, Sydney, Australia.

name: Renal Division, Beijing Anzhen Hospital, Capital Medical University, China (N.Y., H.C.).

name: Department of Nephrology and Laboratory Medicine, Kanazawa University, Ishikawa, Japan (M.O.).

name: Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, The Netherlands (H.J.L.H., D.d.Z.).

name: Indiana University School of Medicine and VA Medical Center, Indianapolis (R.A.).

name: Department of Medicine, University of Chicago Medicine, IL (G.B.).

name: School of Public Health and Community Medicine (A.E.S.), University of New South Wales, Sydney, Australia.

name: Department of Cardiology, Royal Prince Alfred Hospital, Sydney Medical School, Australia (C.A.).

name: Division of Nephrology (T.I.C.), Stanford University School of Medicine, CA.

name: Department of Medicine, Stanford Hypertension Center (T.I.C.), Stanford University School of Medicine, CA.

name: Department of Nephrology, Hospital Clínico Universitario, Valencia, Spain (J.L.G.).

name: Cardiovascular Division, Brigham and Women’s Hospital, Boston, MA (C.P.C.).

name: Baim Institute for Clinical Research, Boston, MA (C.P.C., D.M.C.).

name: Nephrology Division, New York University Langone Medical Center, New York University School of Medicine, New York, NY (D.M.C.).

name: Division of Nephrology, University of British Columbia, Vancouver, Canada (A.L.).

name: Stanford Center for Clinical Research (K.W.M.), Stanford University School of Medicine, CA.

name: The Charles Perkins Centre (B.N.), University of Sydney, Australia.

name: Kolling Institute of Medical Research, Sydney Medical School (C.P.), University of Sydney, Australia.

name: Royal North Shore Hospital, Sydney, Australia (C.P., V.P.).

name: Department of Renal Medicine, University College London Medical School, United Kingdom (D.C.W.).

name: Imperial College London, United Kingdom (B.N.).

ReferenceCitation: Sarraju A, Li J, Cannon CP, Chang TI, Agarwal R, Bakris G, Charytan DM, de Zeeuw D, Greene T, Heerspink HJL, Levin A, Neal B, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Perkovic V, Jardine M, Mahaffey KW. Effects of canagliflozin on cardiovascular, renal, and safety outcomes in participants with type 2 diabetes and chronic kidney disease according to history of heart failure: Results from the CREDENCE trial. Am Heart J. 2021 Mar;233:141-148. doi: 10.1016/j.ahj.2020.12.008. Epub 2020 Dec 22.

ReferenceCitation: Durkin M, Blais J. Linear Projection of Estimated Glomerular Filtration Rate Decline with Canagliflozin and Implications for Dialysis Utilization and Cost in Diabetic Nephropathy. Diabetes Ther. 2021 Feb;12(2):499-508. doi: 10.1007/s13300-020-00953-4. Epub 2020 Dec 18.

ReferenceCitation: Willis M, Nilsson A, Kellerborg K, Ball P, Roe R, Traina S, Beale R, Newell I. Cost-Effectiveness of Canagliflozin Added to Standard of Care for Treating Diabetic Kidney Disease (DKD) in Patients with Type 2 Diabetes Mellitus (T2DM) in England: Estimates Using the CREDEM-DKD Model. Diabetes Ther. 2021 Jan;12(1):313-328. doi: 10.1007/s13300-020-00968-x. Epub 2020 Dec 2.

ReferenceCitation: Willis M, Asseburg C, Slee A, Nilsson A, Neslusan C. Development and Internal Validation of a Discrete Event Simulation Model of Diabetic Kidney Disease Using CREDENCE Trial Data. Diabetes Ther. 2020 Nov;11(11):2657-2676. doi: 10.1007/s13300-020-00923-w. Epub 2020 Sep 15.

ReferenceCitation: Jardine MJ, Zhou Z, Mahaffey KW, Oshima M, Agarwal R, Bakris G, Bajaj HS, Bull S, Cannon CP, Charytan DM, de Zeeuw D, Di Tanna GL, Greene T, Heerspink HJL, Levin A, Neal B, Pollock C, Qiu R, Sun T, Wheeler DC, Zhang H, Zinman B, Rosenthal N, Perkovic V; CREDENCE Study Investigators. Renal, Cardiovascular, and Safety Outcomes of Canagliflozin by Baseline Kidney Function: A Secondary Analysis of the CREDENCE Randomized Trial. J Am Soc Nephrol. 2020 May;31(5):1128-1139. doi: 10.1681/ASN.2019111168.

name: on behalf of the CREDENCE Study Investigators

journal_name: Journal of the American Society of Nephrology

repositories:
PubMed Central
UCL Discovery
spiral.imperial.ac.uk

ReferenceCitation: Cannon CP, Perkovic V, Agarwal R, Baldassarre J, Bakris G, Charytan DM, de Zeeuw D, Edwards R, Greene T, Heerspink HJL, Jardine MJ, Levin A, Li JW, Neal B, Pollock C, Wheeler DC, Zhang H, Zinman B, Mahaffey KW. Evaluating the Effects of Canagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease According to Baseline HbA1c, Including Those With HbA1c <7%: Results From the CREDENCE Trial. Circulation. 2020 Feb 4;141(5):407-410. doi: 10.1161/CIRCULATIONAHA.119.044359. Epub 2019 Nov 11.

name: Cardiovascular Division, Brigham & Women’s Hospital and Baim Institute for Clinical Research, Boston, MA (C.P.C.).

name: The George Institute for Global Health, UNSW Sydney, Australia (V.P., H.J.L.H, M.J.J., J.-W.L., B.N.).

name: The Royal North Shore Hospital, Sydney, Australia (V.P.).

name: Janssen Research & Development, LLC, Raritan, NJ (J.B., R.E.).

name: Nephrology Division, NYU School of Medicine and NYU Langone Medical Center (D.M.C.).

name: Baim Institute for Clinical Research, Boston, MA (D.M.C.).

name: Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, The Netherlands (D.d.Z., H.J.L.H.).

name: Division of Biostatistics, Department of Population Health Sciences, University of Utah, Salt Lake City (T.G.).

name: The Charles Perkins Centre, University of Sydney, Australia (B.N.).

name: Kolling Institute of Medical Research, Sydney Medical School, University of Sydney, Royal North Shore Hospital, St Leonards, New South Wales, Australia (C.P.).

name: Department of Renal Medicine, UCL Medical School, London, United Kingdom (D.C.W.).

name: Renal Division of Peking University First Hospital, Beijing, China (H.Z.).

name: Lunenfeld-Tanenbaum Research Institute, Mt Sinai Hospital, University of Toronto, Ontario, Canada (B.Z.).

ReferenceCitation: Mahaffey KW, Jardine MJ, Bompoint S, Cannon CP, Neal B, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Capuano G, de Zeeuw D, Greene T, Levin A, Pollock C, Sun T, Wheeler DC, Yavin Y, Zhang H, Zinman B, Rosenthal N, Brenner BM, Perkovic V. Canagliflozin and Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus and Chronic Kidney Disease in Primary and Secondary Cardiovascular Prevention Groups. Circulation. 2019 Aug 27;140(9):739-750. doi: 10.1161/CIRCULATIONAHA.119.042007. Epub 2019 Jul 11.

name: George Institute for Global Health, University of New South Wales, Sydney, Australia (M.J.J., S.B., B.N., H.J.L.H., V.P.).

name: Cardiovascular Division, Brigham & Women’s Hospital, Boston, MA (C.P.C.).

name: Baim Institute for Clinical Research, Boston, MA (D.M.C., C.P.C., B.M.B.).

name: Nephrology Division, NYU School of Medicine and NYU Langone Medical Center, New York (D.M.C.).

name: Janssen Research & Development, LLC, Raritan, NJ (R.E., S.B., G.C., T.S., Y.Y., N.R.).

name: Kolling Institute of Medical Research, Sydney Medical School, University of Sydney, Royal North Shore Hospital, St. Leonards, NSW, Australia (C.P.).

name: Department of Renal Medicine, UCL Medical School, London, UK (D.C.W.).

name: Lunenfeld-Tanenbaum Research Institute, Mt. Sinai Hospital, University of Toronto, ON, Canada (B.Z.).

name: Renal Division and Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (B.M.B.).

name: On behalf of the CREDENCE Study Investigators

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

ReferenceCitation: Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW; CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14.

name: From the George Institute for Global Health, University of New South Wales Sydney (V.P., M.J.J., B.N., S. Bompoint), the Royal North Shore Hospital (V.P.), Concord Repatriation General Hospital (M.J.J.), and the Charles Perkins Centre, University of Sydney (B.N.), Sydney, and the Kolling Institute of Medical Research, Sydney Medical School, University of Sydney, Royal North Shore Hospital, St. Leonards, NSW (C.P.) — all in Australia; Imperial College London (B.N.) and the Department of Renal Medicine,...

repositories_institution: Aston University - Aston Publications Explorer

title: Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy

ReferenceCitation: Jardine MJ, Mahaffey KW, Neal B, Agarwal R, Bakris GL, Brenner BM, Bull S, Cannon CP, Charytan DM, de Zeeuw D, Edwards R, Greene T, Heerspink HJL, Levin A, Pollock C, Wheeler DC, Xie J, Zhang H, Zinman B, Desai M, Perkovic V; CREDENCE study investigators. The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Study Rationale, Design, and Baseline Characteristics. Am J Nephrol. 2017 Dec 13;46(6):462-472. doi: 10.1159/000484633. [Epub ahead of print]

name: on behalf of the CREDENCE study investigators

location_country:
Guatemala
Malaysia
Romania
Australia
Russian Federation
Taiwan
Ukraine
India
France
Japan
Lithuania
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
United Arab Emirates
Philippines
Bulgaria
Hungary
Puerto Rico
China
Germany
United States
United Kingdom
Brazil
Serbia
Mexico
Czechia
New Zealand
Spain

title: A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy

summary: The goal of this study is to assess whether canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).


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

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

family: Grand

full_name: Johannes Grand

given: Johannes

family: Miger

full_name: Kristina Miger

given: Kristina

family: Sajadieh

full_name: Ahmad Sajadieh

given: Ahmad

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

family: Køber

full_name: Lars Køber

given: Lars

name: Department of Cardiology Hillerød Hospital Hillerød Denmark

family: Torp‐Pedersen

full_name: Christian Torp‐Pedersen

given: Christian

name: Comprehensive Heart Failure Center University Hospital Würzburg Germany

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

family: Ertl

full_name: Georg Ertl

given: Georg

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

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

family: López‐Sendón

full_name: José López‐Sendón

given: José

family: Pietro Maggioni

full_name: Aldo Pietro Maggioni

given: Aldo

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

family: Teerlink

full_name: John R. Teerlink

given: John R.

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

family: Sato

full_name: Naoki Sato

given: Naoki

family: Gimpelewicz

full_name: Claudio Gimpelewicz

given: Claudio

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

family: Metra

full_name: Marco Metra

given: Marco

family: Holbro

full_name: Thomas Holbro

given: Thomas

family: Nielsen

full_name: Olav W. Nielsen

given: Olav W.

currency_apc_doaj: USD

journal_name: Journal of the American Heart Association

oa_host_type: publisher

evidence: oa journal (via doaj)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

status: Terminated

lead_sponsor: Novartis Pharmaceuticals

location_country:
Finland
Greece
Romania
Belgium
Russian Federation
Iceland
Croatia
France
Lithuania
Poland
Slovakia
Slovenia
Switzerland
Bulgaria
Hungary
Portugal
Germany
United Kingdom
Italy
Austria
Serbia
Czechia
Spain
Estonia
Latvia

acronym: RELAX-AHF-EU

source: euctr

title: A Multicenter, Prospective, Randomized, Open-label Study to Assess the Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients

summary: This was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF).


title: Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism

acronym: EinsteinChoice

summary:
This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy.

Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial

primary_purpose: Prevention

ReferenceCitation: Weitz JI, Bauersachs R, Beyer-Westendorf J, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Holberg G, Kakkar A, Lensing AW, Prins M, Haskell L, van Bellen B, Verhamme P, Wells PS, Prandoni P; EINSTEIN CHOICE Investigators. Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study. Thromb Haemost. 2015 Aug 31;114(3):645-50. doi: 10.1160/TH15-02-0131. Epub 2015 May 21.

ReferenceCitation: Weitz JI, Lensing AWA, Prins MH, Bauersachs R, Beyer-Westendorf J, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Decousus H, Freitas MCS, Holberg G, Kakkar AK, Haskell L, van Bellen B, Pap AF, Berkowitz SD, Verhamme P, Wells PS, Prandoni P; EINSTEIN CHOICE Investigators. Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism. N Engl J Med. 2017 Mar 30;376(13):1211-1222. doi: 10.1056/NEJMoa1700518. Epub 2017 Mar 18.

family: Weitz

full_name: Jeffrey I. Weitz

given: Jeffrey I.

family: Lensing

full_name: Anthonie W.A. Lensing

given: Anthonie W.A.

family: Prins

full_name: Martin H. Prins

given: Martin H.

family: Bauersachs

full_name: Rupert Bauersachs

given: Rupert

family: Beyer-Westendorf

full_name: Jan Beyer-Westendorf

given: Jan

family: Bounameaux

full_name: Henri Bounameaux

given: Henri

family: Brighton

full_name: Timothy A. Brighton

given: Timothy A.

family: Cohen

full_name: Alexander T. Cohen

given: Alexander T.

family: Davidson

full_name: Bruce L. Davidson

given: Bruce L.

family: Decousus

full_name: Hervé Decousus

given: Hervé

family: Freitas

full_name: Maria C.S. Freitas

given: Maria C.S.

family: Holberg

full_name: Gerlind Holberg

given: Gerlind

family: Kakkar

full_name: Ajay K. Kakkar

given: Ajay K.

family: Haskell

full_name: Lloyd Haskell

given: Lloyd

family: van Bellen

full_name: Bonno van Bellen

given: Bonno

family: Pap

full_name: Akos F. Pap

given: Akos F.

family: Berkowitz

full_name: Scott D. Berkowitz

given: Scott D.

family: Verhamme

full_name: Peter Verhamme

given: Peter

family: Wells

full_name: Philip S. Wells

given: Philip S.

family: Prandoni

full_name: Paolo Prandoni

given: Paolo

journal_name: New England Journal of Medicine

oa_colors: green other

evidence: open (via free article)

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

repository_institution: University of Geneva - Archive ouverte UNIGE

location_country:
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Poland
Thailand
Norway
Canada
Korea, Republic of
South Africa
Sweden
Switzerland
Netherlands
Philippines
Vietnam
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Turkey


title: A Long-term Follow-up of Adult Kidney and Liver Allograft Recipients Previously Enrolled Into a Tacrolimus (Advagraf) Trial. A Multicentre Non-interventional Post Authorization Study (PAS)

acronym: ADDRESS

summary: The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients. This study will also evaluate the overall long-term impact of Advagraf on kidney and liver allograft recipients.

time_perspective: Prospective

ipd_sharing_description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
Finland
Romania
Belgium
Russian Federation
France
Poland
Slovakia
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Hungary
Ireland
Portugal
Germany
United Kingdom
Italy
Austria
Czechia
Belarus
Spain
Estonia
Latvia

location_facility:
Site PT35102
Site ES34006
Site IT39009
Site CZ42006
Site ES34016
Site FR33007
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Site BE32007
Site DE49008
Site FR33024


ReferenceCitation: Dimier N, Delmar P, Ward C, Morariu-Zamfir R, Fingerle-Rowson G, Bahlo J, Fischer K, Eichhorst B, Goede V, van Dongen JJM, Ritgen M, Böttcher S, Langerak AW, Kneba M, Hallek M. A model for predicting effect of treatment on progression-free survival using MRD as a surrogate end point in CLL. Blood. 2018 Mar 1;131(9):955-962. doi: 10.1182/blood-2017-06-792333. Epub 2017 Dec 18.

name: Roche Products Ltd, Welwyn, United Kingdom;

family: Dimier

full_name: Natalie Dimier

given: Natalie

name: F. Hoffmann-La Roche Ltd, Basel, Switzerland;

family: Delmar

full_name: Paul Delmar

given: Paul

family: Ward

full_name: Carol Ward

given: Carol

family: Morariu-Zamfir

full_name: Rodica Morariu-Zamfir

given: Rodica

family: Fingerle-Rowson

full_name: Günter Fingerle-Rowson

given: Günter

name: Department I of Internal Medicine, Center of Integrated Oncology Cologne-Bonn, University Hospital Cologne, Cologne, Germany;

family: Bahlo

full_name: Jasmin Bahlo

given: Jasmin

family: Fischer

full_name: Kirsten Fischer

given: Kirsten

family: Eichhorst

full_name: Barbara Eichhorst

given: Barbara

family: Goede

full_name: Valentin Goede

given: Valentin

name: Department of Immunology, Laboratory for Medical Immunology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands;

name: Department of Immunohematology and Blood Transfusion, Leiden University Medical Center, Leiden, The Netherlands;

family: van Dongen

full_name: Jacques J. M. van Dongen

given: Jacques J. M.

name: Second Department of Medicine, University of Schleswig-Holstein, Kiel, Germany; and

family: Ritgen

full_name: Matthias Ritgen

given: Matthias

name: Department of Hematology, Oncology and Palliative Medicine, Center for Internal Medicine, University of Rostock, Rostock, Germany

family: Böttcher

full_name: Sebastian Böttcher

given: Sebastian

family: Langerak

full_name: Anton W. Langerak

given: Anton W.

family: Kneba

full_name: Michael Kneba

given: Michael

family: Hallek

full_name: Michael Hallek

journal_name: Blood

repository_institution: Erasmus University, Rotterdam - RePub

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

lead_sponsor: Hoffmann-La Roche

location_country:
Romania
Australia
Russian Federation
Denmark
Spain
Croatia
France
Thailand
Slovakia
Argentina
Canada
Hong Kong
Netherlands
Switzerland
Bulgaria
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Egypt
New Zealand
Estonia

title: An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities.

summary: This open-label, randomized, 3-arm study will evaluate the efficacy and safety of (obinutuzumab) RO5072759 in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.


ReferenceCitation: Lynch TJ, Bondarenko I, Luft A, Serwatowski P, Barlesi F, Chacko R, Sebastian M, Neal J, Lu H, Cuillerot JM, Reck M. Ipilimumab in combination with paclitaxel and carboplatin as first-line treatment in stage IIIB/IV non-small-cell lung cancer: results from a randomized, double-blind, multicenter phase II study. J Clin Oncol. 2012 Jun 10;30(17):2046-54. doi: 10.1200/JCO.2011.38.4032. Epub 2012 Apr 30. Erratum in: J Clin Oncol. 2012 Oct 10;30(29):3654.

ReferenceCitation: Reck M, Bondarenko I, Luft A, Serwatowski P, Barlesi F, Chacko R, Sebastian M, Lu H, Cuillerot JM, Lynch TJ. Ipilimumab in combination with paclitaxel and carboplatin as first-line therapy in extensive-disease-small-cell lung cancer: results from a randomized, double-blind, multicenter phase 2 trial. Ann Oncol. 2013 Jan;24(1):75-83. doi: 10.1093/annonc/mds213. Epub 2012 Aug 2.

ReferenceCitation: Margolin K, Ernstoff MS, Hamid O, Lawrence D, McDermott D, Puzanov I, Wolchok JD, Clark JI, Sznol M, Logan TF, Richards J, Michener T, Balogh A, Heller KN, Hodi FS. Ipilimumab in patients with melanoma and brain metastases: an open-label, phase 2 trial. Lancet Oncol. 2012 May;13(5):459-65. doi: 10.1016/S1470-2045(12)70090-6. Epub 2012 Mar 27.

status: Active, not recruiting

lead_sponsor: European Thoracic Oncology Platform

location_country:
Switzerland
Netherlands
France
Belgium
Australia
Spain
Germany
United Kingdom

acronym: STIMULI

location_facility: Royal Brisbane and Women's Hospital (QLD)

location_facility: University Hospital Gasthuisberg, KU Leuven

location_facility: Hospital Universitario Fundacion Jimenez Díaz

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Hospital Clínico Universitario De Valencia

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hospital Universitario Central De Asturias

title: A Randomised Open-label Phase II Trial of Consolidation With Nivolumab and Ipilimumab in Limited-stage SCLC After Chemo-radiotherapy

summary:
Despite the fact that the majority of the patients with limited disease SCLC will respond very well to the standard treatment, a great proportion will relapse within 12 - 24 months.

Several studies in patients with lung cancer suggested a possible favourable association between the increased presence of immunologically active cells in the tumour and survival. Nivolumab and ipilimumab are proteins, which help your immune system to attack and destroy cancer cells by your immune cells. Early clinical trials with nivolumab and ipilimumab have shown activity in a broad range of cancers, including SCLC.

The aim of the current study is to investigate the efficacy (how well the treatment works) and tolerability (how severe the side effects are) of the standard treatment (chemotherapy and radiotherapy) alone, compared with the standard treatment followed by nivolumab and ipilimumab in patients with limited SCLC.

status_simplified: Ongoing


title: A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With gBRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

acronym: OlympiA

summary: Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

ReferenceCitation: Tutt ANJ, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, Gelber RD, de Azambuja E, Fielding A, Balmaña J, Domchek SM, Gelmon KA, Hollingsworth SJ, Korde LA, Linderholm B, Bandos H, Senkus E, Suga JM, Shao Z, Pippas AW, Nowecki Z, Huzarski T, Ganz PA, Lucas PC, Baker N, Loibl S, McConnell R, Piccart M, Schmutzler R, Steger GG, Costantino JP, Arahmani A, Wolmark N, McFadden E, Karantza V, Lakhani SR, Yothers G, Campbell C, Geyer CE Jr; OlympiA Clinical Trial Steering Committee and Investigators. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. N Engl J Med. 2021 Jun 24;384(25):2394-2405. doi: 10.1056/NEJMoa2105215. Epub 2021 Jun 3.

name: From the Breast Cancer Now Toby Robins Research Centre, the Institute of Cancer Research (A.N.J.T.), and the Breast Cancer Now Unit, Guy’s Hospital Cancer Centre, King’s College London (A.N.J.T.), London, AstraZeneca, Cambridge (S.J.H., N.B.), and Frontier Science (Scotland), Kincraig (R.M.C., E.M.F., C.C.) — all in the United Kingdom; Dana–Farber Cancer Institute, Harvard Medical School (J.E.G., R.D.G.), Frontier Science Foundation (R.D.G.), and Harvard T.H. Chan School of Public Health (R.D.G.) — all...

family: Tutt

full_name: Andrew N.J. Tutt

given: Andrew N.J.

family: Garber

full_name: Judy E. Garber

given: Judy E.

family: Kaufman

full_name: Bella Kaufman

given: Bella

family: Viale

full_name: Giuseppe Viale

given: Giuseppe

family: Fumagalli

full_name: Debora Fumagalli

given: Debora

family: Rastogi

full_name: Priya Rastogi

given: Priya

family: Gelber

full_name: Richard D. Gelber

given: Richard D.

family: de Azambuja

full_name: Evandro de Azambuja

given: Evandro

family: Fielding

full_name: Anitra Fielding

given: Anitra

family: Balmaña

full_name: Judith Balmaña

given: Judith

family: Domchek

full_name: Susan M. Domchek

given: Susan M.

family: Gelmon

full_name: Karen A. Gelmon

given: Karen A.

family: Hollingsworth

full_name: Simon J. Hollingsworth

given: Simon J.

family: Korde

full_name: Larissa A. Korde

given: Larissa A.

family: Linderholm

full_name: Barbro Linderholm

given: Barbro

family: Bandos

full_name: Hanna Bandos

given: Hanna

family: Senkus

full_name: Elżbieta Senkus

given: Elżbieta

family: Suga

full_name: Jennifer M. Suga

given: Jennifer M.

family: Shao

full_name: Zhimin Shao

given: Zhimin

family: Pippas

full_name: Andrew W. Pippas

given: Andrew W.

family: Nowecki

full_name: Zbigniew Nowecki

given: Zbigniew

family: Huzarski

full_name: Tomasz Huzarski

given: Tomasz

family: Ganz

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.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Australia
Belgium
Taiwan
Iceland
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Hungary
Puerto Rico
Portugal
China
Germany
United States
United Kingdom
Italy
Austria
Israel
Spain


ReferenceCitation: Gandara D, Reck M, Moro-Sibilot D, Mazieres J, Gadgeel S, Morris S, Cardona A, Mendus D, Ballinger M, Rittmeyer A, Peters S. Fast progression in non-small cell lung cancer: results from the randomized phase III OAK study evaluating second-line atezolizumab versus docetaxel. J Immunother Cancer. 2021 Mar;9(3). pii: e001882. doi: 10.1136/jitc-2020-001882.

family: Gandara

full_name: David Gandara

given: David

family: Reck

full_name: Martin Reck

given: Martin

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Mazieres

full_name: Julien Mazieres

given: Julien

family: Gadgeel

full_name: Shirish Gadgeel

given: Shirish

family: Morris

full_name: Stefanie Morris

given: Stefanie

family: Cardona

full_name: Andres Cardona

given: Andres

family: Mendus

full_name: Diana Mendus

given: Diana

family: Ballinger

full_name: Marcus Ballinger

given: Marcus

family: Rittmeyer

full_name: Achim Rittmeyer

given: Achim

family: Peters

full_name: Solange Peters

given: Solange

journal_name: Journal for ImmunoTherapy of Cancer

oa_colors: green gold

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: California Digital Library - eScholarship

repository_normalized: California Digital Library - eScholarship

evidence: oa repository (via pmcid lookup)

repositories: California Digital Library - eScholarship

repositories_institution: California Digital Library - eScholarship

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Fast progression in non–small cell lung cancer: results from the randomized phase III OAK study evaluating second-line atezolizumab versus docetaxel

ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

name: Clinical Pharmacology Genentech Inc. South San Francisco CA USA

family: Shemesh

full_name: Colby S. Shemesh

given: Colby S.

family: Chan

full_name: Phyllis Chan

given: Phyllis

name: Clinical Science Genentech Inc. South San Francisco CA USA

family: Legrand

full_name: Fatema A. Legrand

given: Fatema A.

name: Biomarkers Genentech Inc. South San Francisco CA USA

family: Shames

full_name: David S. Shames

given: David S.

family: Das Thakur

full_name: Meghna Das Thakur

given: Meghna

name: Safety Science F. Hoffmann‐La Roche Ltd. Shanghai China

family: Shi

full_name: Jane Shi

given: Jane

name: Safety Science Roche Products Ltd. Welwyn Garden City United Kingdom

family: Bailey

full_name: Lorna Bailey

given: Lorna

name: Biometrics Genentech Inc. South San Francisco CA USA

name: Clinical Pharmacology Genentech‐Roche Marseille France

title: Pan‐cancer population pharmacokinetics and exposure‐safety and ‐efficacy analyses of atezolizumab in patients with high tumor mutational burden

ReferenceCitation: Chalabi M, Cardona A, Nagarkar DR, Dhawahir Scala A, Gandara DR, Rittmeyer A, Albert ML, Powles T, Kok M, Herrera FG; imCORE working group of early career investigators. Efficacy of chemotherapy and atezolizumab in patients with non-small-cell lung cancer receiving antibiotics and proton pump inhibitors: pooled post hoc analyses of the OAK and POPLAR trials. Ann Oncol. 2020 Apr;31(4):525-531. doi: 10.1016/j.annonc.2020.01.006. Epub 2020 Jan 16.

ReferenceCitation: Morrissey KM, Marchand M, Patel H, Zhang R, Wu B, Phyllis Chan H, Mecke A, Girish S, Jin JY, Winter HR, Bruno R. Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting. Cancer Chemother Pharmacol. 2019 Dec;84(6):1257-1267. doi: 10.1007/s00280-019-03954-8. Epub 2019 Sep 21.

ReferenceCitation: Gadgeel SM, Lukas RV, Goldschmidt J, Conkling P, Park K, Cortinovis D, de Marinis F, Rittmeyer A, Patel JD, von Pawel J, O'Hear C, Lai C, Hu S, Ballinger M, Sandler A, Gandhi M, Fehrenbacher L. Atezolizumab in patients with advanced non-small cell lung cancer and history of asymptomatic, treated brain metastases: Exploratory analyses of the phase III OAK study. Lung Cancer. 2019 Feb;128:105-112. doi: 10.1016/j.lungcan.2018.12.017. Epub 2018 Dec 19.

ReferenceCitation: Bordoni R, Ciardiello F, von Pawel J, Cortinovis D, Karagiannis T, Ballinger M, Sandler A, Yu W, He P, Matheny C, Felizzi F, Rittmeyer A. Patient-Reported Outcomes in OAK: A Phase III Study of Atezolizumab Versus Docetaxel in Advanced Non-Small-cell Lung Cancer. Clin Lung Cancer. 2018 Sep;19(5):441-449.e4. doi: 10.1016/j.cllc.2018.05.011. Epub 2018 May 31.

title: Patient-Reported Outcomes in OAK: A Phase III Study of Atezolizumab Versus Docetaxel in Advanced Non–Small-cell Lung Cancer

ReferenceCitation: Hida T, Kaji R, Satouchi M, Ikeda N, Horiike A, Nokihara H, Seto T, Kawakami T, Nakagawa S, Kubo T. Atezolizumab in Japanese Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer: A Subgroup Analysis of the Phase 3 OAK Study. Clin Lung Cancer. 2018 Jul;19(4):e405-e415. doi: 10.1016/j.cllc.2018.01.004. Epub 2018 Feb 1.

title: Atezolizumab in Japanese Patients With Previously Treated Advanced Non–Small-Cell Lung Cancer: A Subgroup Analysis of the Phase 3 OAK Study

ReferenceCitation: Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, Gadgeel SM, Hida T, Kowalski DM, Dols MC, Cortinovis DL, Leach J, Polikoff J, Barrios C, Kabbinavar F, Frontera OA, De Marinis F, Turna H, Lee JS, Ballinger M, Kowanetz M, He P, Chen DS, Sandler A, Gandara DR; OAK Study Group. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017 Jan 21;389(10066):255-265. doi: 10.1016/S0140-6736(16)32517-X. Epub 2016 Dec 13. Erratum in: Lancet. 2017 Apr 8;389(10077):e5.

location_country:
Guatemala
Finland
Greece
Russian Federation
Taiwan
Ukraine
France
Japan
Panama
Poland
Thailand
Norway
Argentina
Canada
Korea, Republic of
Chile
Sweden
Switzerland
Netherlands
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Austria
Brazil
Serbia
New Zealand
Spain
Turkey

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna

location_facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

location_facility: National Hospital Organization Kyushu Cancer Center, Thoracic Oncology

location_facility: Kaiser Permanente - San Francisco (2238 Geary)

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

location_facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie

location_facility: Yonsei University Severance Hospital; Medical Oncology

location_facility: Hematology-Oncology; Associates of the Quad Cities

location_facility: Texas Oncology, P.A. - Tyler; Tyler Cancer Center

location_facility: Izmir Suat Seren Chest Diseases and Surgery Research Hospital

location_facility: University Hospital of Patras Medical Oncology

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie

location_facility: The Cancer Institute Hospital of JFCR, Respiratory Medicine

location_facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie

location_facility: Lkh Vöcklabruck; I. Abt. Für Innere Medizin

location_facility: A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina

location_facility: National Cancer Center Hospital; Thoracic Medical Oncology

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: Azienda Ospedaliero-Uni Ria Di Udine; Dept. Di Oncologia - Padiglione Pennato

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Centre Jean Bernard; Radiotherapie Chimiotherapie

location_facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

location_facility: National Hospital Organization Shikoku Cancer Center; Internal Medicine

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Semmelweis Egyetem X; Pulmonologiai Klinika

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: Univ of Calif, Los Angeles; Hematology/Oncology

location_facility: North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Luzerner Kantonsspital; Medizinische Onkologie

location_facility: Miyagi Cancer Center; Respiratory Medicine

location_facility: Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology

location_facility: National Cancer Center; Medical Oncology

location_facility: New York Oncology Hematology PC - Latham

location_facility: Azienda Ospedaliera Univ Parma; Dept Oncologia Medica

location_facility: Seoul National Uni Hospital; Internal Medicine

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: National Cancer Center Hospital East; Thoracic Oncology

location_facility: Helsinki University Central Hospital; Dep. of Pulmonary Medicine

location_facility: National Taiwan Uni Hospital; Internal Medicine

location_facility: Roy & Patricia Disney Family Cancer Center

location_facility: POLICLINICO RODOLICO, U.O. di Oncologia Medica

location_facility: National Hospital Organization, Yamaguchi - Ube Medical Center; Oncology Medicine

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II

location_facility: Uzhgorod Nat. University Central Municip Hosp; Onc Center

location_facility: Samsung Medical Center; Gastroenterology

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: University of Pecs, I st Dept of Internal Medicine

location_facility: US Oncology Research at Minnesota Oncology

location_facility: Hospital Pulido Valente; Servico de Pneumologia

location_facility: Kindai University Hospital; Medical Oncology

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Seoul National University Bundang Hospital; Hematology Medical Oncology

location_facility: Institute for pulmonary diseases of Vojvodina

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Tokyo Medical University Hospital; Dept of Surgery

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Centre Hospitalier Lyon Sud; Pneumologie

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Catharina Ziekenhuis; Dept of Lung Diseases

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Karolinska Universitetssjukhuset, Solna; Lung Allergikliniken N10:02

location_facility: St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr

location_facility: Aurora Health Care; Patient Centered Research

location_facility: Okayama University Hospital; Respiratory and Allergy Medicine

location_facility: Willamette Valley Cancer Ctr - 520 Country Club

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

location_facility: Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin

location_facility: Waikato Hospital; Dept of Medical Oncology

location_facility: Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building

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

location_facility: Kaiser Permanente - Franklin; Kaiser Permanente - Lone Tree

location_facility: Aichi Cancer Center Hospital; Respiratory Medicine

location_facility: Centre Hospitalier Intercommunal; Service de Pneumologie

location_facility: Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Saitama Cancer Center; Thoracic Oncology

location_facility: Seoul St.Mary's Hospital; Medical Oncology

location_facility: Shizuoka Cancer Center; Thoracic Oncology

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

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Kobe City Medical Center General Hospital; Respiratory Medicine

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: St. Mary's Hospital Regional Cancer Center

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

location_facility: Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas

location_facility: Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique

location_facility: Seconda Universita' Degli Studi; Divsione Di Oncologia Medica

location_facility: Luckow Pavillion, Valley Hosp; Office of Clinical Trials

location_facility: Antonius Ziekenhuis; Dept of Lung Diseases

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

location_facility: Clinic for Pulmonology, Clinical Center of Serbia

location_facility: Kantonsspital Baden; Medizinische Klinik, Onkologie

location_facility: Cancer Treatment Centers of America-Tulsa

title: A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy

summary: This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.


title: EnteroCT With Enteroclysis Versus Enterography-MRI for the Diagnosis of Tumors of the Small Intestine: a Pilot Study

acronym: enteroMRI-TSI

summary:
Early diagnosis of tumors of the small intestine is a challenge for clinicians and for radiologists. The detection of tumors of the small intestine is a field in which the video capsule endoscopy has the lowest performance.

The entero-CT with enteroclysis is the imaging technique used primarily to explore patients with a strong suspicion of small intestine tumors. However the entero-CT with enteroclysis has disadvantages : it is irradiating, the nasojejunal tube implies a discomfort to the patient and it is a complicated examination in terms of logistics with necessity of specific equipment to insert the nasojejunal tube.

MRI has been proposed as an alternative imaging technique and satisfactory results have been reported with the MRI enteroclysis. However, this technique has several disadvantages related to nasojejunal tube insertion and the necessity of equipment compatible with the high magnetic fields. The enterography-MRI without enteroclysis, whose principle is to distend the small intestine by ingestion of large quantities of a liquid, has a major and undisputed role in the exploration of Crohn's disease of the small bowel. However, its capacity for distension of the small intestine for optimal tumor detection is questioned and its role in tumor detection is largely unknown.

primary_purpose: Diagnostic

lead_sponsor: CHU de Reims

intervention_type: Radiation

lead_sponsor_type: academique