ReferenceCitation: DeVries JH, Bain SC, Rodbard HW, Seufert J, D'Alessio D, Thomsen AB, Zychma M, Rosenstock J; Liraglutide-Detemir Study Group. Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets. Diabetes Care. 2012 Jul;35(7):1446-54. doi: 10.2337/dc11-1928. Epub 2012 May 14.

family: DeVries

full_name: J. H. DeVries

given: J. H.

family: Bain

full_name: S. C. Bain

given: S. C.

family: Rodbard

full_name: H. W. Rodbard

given: H. W.

family: Seufert

full_name: J. Seufert

family: D'Alessio

full_name: D. D'Alessio

given: D.

family: Thomsen

full_name: A. B. Thomsen

given: A. B.

family: Zychma

full_name: M. Zychma

family: Rosenstock

full_name: J. Rosenstock

name: on behalf of the Liraglutide-Detemir Study Group

journal_name: Diabetes Care

oa_colors: green other

evidence: open (via page says license)

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Sequential Intensification of Metformin Treatment in Type 2 Diabetes With Liraglutide Followed by Randomized Addition of Basal Insulin Prompted by A1C Targets

ReferenceCitation: Rosenstock J, Rodbard HW, Bain SC, D'Alessio D, Seufert J, Thomsen AB, Svendsen CB, DeVries JH; Liraglutide-Detemir Study Group. One-year sustained glycemic control and weight reduction in type 2 diabetes after addition of liraglutide to metformin followed by insulin detemir according to HbA1c target. J Diabetes Complications. 2013 Sep-Oct;27(5):492-500. doi: 10.1016/j.jdiacomp.2013.04.008. Epub 2013 Jun 6.

full_name: Julio Rosenstock

given: Julio

full_name: Helena W. Rodbard

given: Helena W.

full_name: Stephen C. Bain

given: Stephen C.

family: D’Alessio

full_name: David D’Alessio

given: David

full_name: Jochen Seufert

given: Jochen

full_name: Anne B. Thomsen

given: Anne B.

family: Svendsen

full_name: Claus Bo Svendsen

given: Claus Bo

full_name: J. Hans DeVries

given: J. Hans

journal_name: Journal of Diabetes and its Complications

oa_host_type: publisher

ReferenceCitation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Review. Erratum in: Diabetes Care. 2015 Aug;38(8):1622.

title: Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical Trials

location_country:
Italy
United States
Netherlands
Germany
France
Belgium
Puerto Rico
Spain
Canada
United Kingdom

title: The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes. A 26 Week, Randomised, Open-label, Parallel-group, Multicentre, Multinational Trial With a 26 Week Extension

summary: This trial is conducted in Europe and North America. The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin in subjects with type 2 diabetes. Subjects will continue their own pre-trial metformin treatment during the trial.


type: Other Identifier

type: EudraCT Number

title: A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy

summary: The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Freedland SJ, De Giorgi U, Gleave M, Rosbrook B, Shen Q, Sugg J, Haas GP, Shore ND. A phase 3 randomised study of enzalutamide plus leuprolide and enzalutamide monotherapy in high-risk non-metastatic hormone-sensitive prostate cancer with rising PSA after local therapy: EMBARK study design. BMJ Open. 2021 Aug 12;11(8):e046588. doi: 10.1136/bmjopen-2020-046588.

family: Freedland

full_name: Stephen J Freedland

given: Stephen J

sequence: first

family: De Giorgi

full_name: Ugo De Giorgi

given: Ugo

sequence: additional

family: Gleave

full_name: Martin Gleave

given: Martin

family: Rosbrook

full_name: Brad Rosbrook

given: Brad

family: Shen

full_name: Qi Shen

given: Qi

family: Sugg

full_name: Jennifer Sugg

given: Jennifer

family: Haas

full_name: Gabriel P Haas

given: Gabriel P

family: Shore

full_name: Neal D Shore

given: Neal D

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ipd_sharing: Yes

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
United States
Brazil
Sweden
Netherlands
Finland
France
Poland
Slovakia
Australia
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Johns Hopkins Kimmel Cancer Center/ Sibley Infusion

location_facility: Maastricht University Medical Center, Department of Urology

location_facility: Urology Associates/ Urologic Medical Research

location_facility: Department of Radiology, University Hospital Salzburg, Austria

location_facility: Azienda Ospedaliera S, Camillo Forlanini, UOC per il governo clinico in Oncologia Medica,pad,Flajani

location_facility: Memorial Sloan Kettering Cancer Center Westchester

location_facility: Memorial Sloan Kettering Cancer Center Commack

location_facility: Memorial Sloan Kettering Cancer Center Nassau

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: Department of Urology,Paracelsus Medical University Salzburg

location_facility: Thomas Jefferson University Hospital, Bodine Buiding

location_facility: Clinique Pasteur - Lanroze Service Pharmacie

location_facility: Lakeland Regional Health Hollis Cancer Center

location_facility: Manitoba Prostate Centre CancerCare Manitoba

location_facility: The University of Kansas Cancer Center and Medical Pavilion

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: UO di Oncologia Medica, Ospedale Santa Maria delle Croci

location_facility: Memorial Sloan Kettering Cancer Center Basking Ridge

location_facility: ICO Girona; Hospital Universitari de Girona Dr. Josep Trueta. Servicio de Oncologia

location_facility: Pusan National University Yangsan Hospital

location_facility: Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization

location_facility: GU Research Network, LLC / Urology Cancer Center

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: Memorial Sloan Kettering Cancer Center Rockville Centre

location_facility: VU Medical Centrum, Department of Urology

location_facility: U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services

location_facility: Kujawsko-Pomorskie Centrum Urologicznw Sp z o.o

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Austria

location_facility: UO di Radiologia, Ospedale Civile degli Infermi

location_facility: Hospital General Universitario Gregorio Maranon. Servicio de Oncologia.

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Centro Oncologico MD Anderson International Espana

location_facility: Vanderbilt Unversity Medical Center, Dept. of Urologic Surgery

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

location_facility: Comprehensive Urology - Royal Oak (Stephenson) office

location_facility: S.C.D.U. Radiodiagnostica, A.O.U. San Luigi Gonzaga

location_facility: Servizio di Farmacia, Ospedale Santa Maria delle Croci

location_facility: GU Research Network/Wichita Urology Group

location_facility: UO di Oncologia,Ospedale Civile degli Infermi

location_facility: Sidney Kimmel Center for Prostate and Urologic Cancers

location_facility: Eastern Connecticut Hematology Oncology Associates

location_facility: Department of Internal Medicine I, Medical university Vienna

location_facility: Urological Associates of Southern Arizona, PC

location_facility: Servizio di Radiologia, Ospedale Santa Maria Delle Croci

location_facility: Associated Medical Professionals of New York, PLLC

location_facility: Chonnam National University Hwasun Hospital

location_facility: Severance Hospital. Yonsei University Health System

location_facility: Laboratorio Farmaci Antiblastici, IRCCS Istituto

location_facility: Monte Tabor Centro Italo Brasileiro de Promocao Sanitaria - Hospital Sao Rafael

location_facility: Farmacia Interna, Ospedale degli Infermi

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o. o.

location_facility: Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner

location_facility: The University of Kansas Cancer Center, Investigational Drug Services

location_facility: Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Urologiczny

location_facility: University of California Davis Medical Center

location_facility: Winship Cancer Institute, Emory University

location_facility: CHU de Quebec - L'Hotel-Dieu de Quebec - CRCEO

location_facility: U.O. Medicina Nucleare, Ospedale Santa Chiara

location_facility: Duke Investigational Chemotherapy Services

location_facility: Seoul National University Bundang Hospital

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

location_facility: Althaia, Xarxa Assistencial Universitària de Manresa

location_facility: Uo di Radiologia, Ospedale Civile Umberto I

location_facility: S.C.D.U. Oncologia Medica, A.O.U. San Luigi Gonzaga

location_facility: UO di Oncologia, Ospedale Civile Umberto I

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Vychodoslovensky onkologicky ustav, a.s.

location_facility: University of California, Davis, School of Medicine

location_facility: Vanderbilt Unversity Medical Center, The Urology Clinic

location_facility: Complejo Hospitalario Universitario de Orense

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: University Health Network - Princess Margaret Cancer Centre

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center

location_facility: Farmacia Ospedaliera, Padiglione specialita, A.O.U. San Luigi Gonzaga

location_facility: U.O. di Oncologia Medica, Ospedale Santa Chiara

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale/Oncologia Medica A

location_facility: TriState Urologic Services PSC Inc., dba The Urology Group

location_facility: CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: Fakultna nemocnica s poliklinikou F.D.Roosevelta

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: UO Radiologia,IRCCS Istituto Scientifico Romagnolo Per lO Studio e la Cura dei Tumori (IRST)

location_facility: Hospital Barmherzige Schwestern Linz, Department of Urology

location_facility: The Male/Female Health and Research Centre, Royal Court Medical Centre

location_facility: University of Alabama at Birmingham, IDS Pharmacy

location_facility: University of California, Irvine Medical Center

location_facility: Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona

location_facility: University Medical Centrum Groningen, Department Urologie

location_facility: Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP

location_facility: UO di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Farmacia, Azienda Socio Sanitaria Territoriale di Cremona

location_facility: CITO - Centro Integrado de Terapia Onco-Hematologica - Hospital da Cidade de Passo Fundo

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Identification and Description of Severe Asthma Patients in a Cross-sectional Study-the IDEAL Study

summary: This will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day. Investigational product will not be administered. Approximately 790 subjects with severe asthma will be screened to achieve a total of at least 750 evaluable study subjects. The study will not include a run-in or follow-up period. This study will provide a more reliable description of the severe asthma patient landscape with respect to the potential eligibility for treatment with mepolizumab, omalizumab, and reslizumab. This study aims to estimate the potential overlap of patients eligible for treatment with mepolizumab and those eligible for treatment with omalizumab and/or reslizumab. Additionally, the current study will also ascertain and describe reslizumab eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient population.

status: Completed

study_completion_date_type: Actual

ReferenceCitation: Müllerová H, Cockle SM, Gunsoy NB, Nelsen LM, Albers FC. Clinical characteristics and burden of illness among adolescent and adult patients with severe asthma by asthma control: the IDEAL study. J Asthma. 2021 Apr;58(4):459-470. doi: 10.1080/02770903.2019.1708095. Epub 2020 Jan 9.

name: Real World Evidence, GSK, Stockley Park, Uxbridge, Middlesex, UK

family: Müllerová

full_name: Hana Müllerová

given: Hana

name: Value Evidence and Outcomes, GSK House, Brentford, Middlesex, UK

family: Cockle

full_name: Sarah M. Cockle

given: Sarah M.

name: Value Evidence and Outcomes, GSK, Stockley Park, Uxbridge, Middlesex, UK

family: Gunsoy

full_name: Necdet B. Gunsoy

given: Necdet B.

family: Nelsen

full_name: Linda M. Nelsen

given: Linda M.

name: Respiratory Medical Franchise, GSK, Research Triangle Park, NC, USA

family: Albers

full_name: Frank C. Albers

given: Frank C.

journal_name: Journal of Asthma

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Nelsen LM, Cockle SM, Gunsoy NB, Jones P, Albers FC, Bradford ES, Mullerova H. Impact of exacerbations on St George's Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study. J Asthma. 2020 Sep;57(9):1006-1016. doi: 10.1080/02770903.2019.1630640. Epub 2019 Jun 28.

name: Patient Centered Outcomes, Value Evidence and Outcomes, GSK, Collegeville, PA, USA;

name: Value Evidence and Outcomes, GSK House, Brentford, UK;

name: Clinical Statistics, GSK, Stockley Park, UK;

name: Respiratory Medical, GSK House, Brentford, UK;

family: Jones

full_name: Paul Jones

given: Paul

name: Respiratory Medical Franchise, GSK SK, Research Triangle Park, NC, USA;

name: Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA;

family: Bradford

full_name: Eric S. Bradford

given: Eric S.

name: Real World Evidence and Epidemiology, GSK, Stockley Park, Uxbridge, UK

family: Mullerova

full_name: Hana Mullerova

evidence: open (via free pdf)

title: Impact of exacerbations on St George’s Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study

ReferenceCitation: Albers FC, Müllerová H, Gunsoy NB, Shin JY, Nelsen LM, Bradford ES, Cockle SM, Suruki RY. Biologic treatment eligibility for real-world patients with severe asthma: The IDEAL study. J Asthma. 2018 Feb;55(2):152-160. doi: 10.1080/02770903.2017.1322611. Epub 2017 Jun 16.

name: Clinical Statistics, GSK, Stockley Park, Uxbridge, Middlesex, UK

family: Shin

full_name: Ji-Yeon Shin

given: Ji-Yeon

name: Worldwide Epidemiology, GSK, Research Triangle Park, NC, USA

name: Department of Epidemiology, UCB Biosciences, Research Triangle Park, NC, USA

location_country:
United States
Germany
France
Australia
Canada
United Kingdom


ReferenceCitation: Connolly SJ, Wallentin L, Ezekowitz MD, Eikelboom J, Oldgren J, Reilly PA, Brueckmann M, Pogue J, Alings M, Amerena JV, Avezum A, Baumgartner I, Budaj AJ, Chen JH, Dans AL, Darius H, Di Pasquale G, Ferreira J, Flaker GC, Flather MD, Franzosi MG, Golitsyn SP, Halon DA, Heidbuchel H, Hohnloser SH, Huber K, Jansky P, Kamensky G, Keltai M, Kim SS, Lau CP, Le Heuzey JY, Lewis BS, Liu L, Nanas J, Omar R, Pais P, Pedersen KE, Piegas LS, Raev D, Smith PJ, Talajic M, Tan RS, Tanomsup S, Toivonen L, Vinereanu D, Xavier D, Zhu J, Wang SQ, Duffy CO, Themeles E, Yusuf S. The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study. Circulation. 2013 Jul 16;128(3):237-43. doi: 10.1161/CIRCULATIONAHA.112.001139. Epub 2013 Jun 14.

name: From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada (S.J.C., J.E., J.P., E.T., S.Y.); Uppsala Clinical Research Centre, and Department of Medical Sciences, Uppsala University, Uppsala, Sweden (L.W., J.O.); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT (P.A.R., S.Q.W., C.O.D.); Boehringer Ingelheim GmbH & Co. KG, Ingelheim, Germany (M.B.); Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany (M.B.);...

family: Connolly

full_name: Stuart J. Connolly

given: Stuart J.

family: Wallentin

full_name: Lars Wallentin

given: Lars

family: Ezekowitz

full_name: Michael D. Ezekowitz

given: Michael D.

family: Eikelboom

full_name: John Eikelboom

given: John

family: Oldgren

full_name: Jonas Oldgren

given: Jonas

family: Reilly

full_name: Paul A. Reilly

given: Paul A.

family: Brueckmann

full_name: Martina Brueckmann

given: Martina

family: Pogue

full_name: Janice Pogue

given: Janice

family: Alings

full_name: Marco Alings

given: Marco

family: Amerena

full_name: John V. Amerena

given: John V.

family: Avezum

full_name: Alvaro Avezum

given: Alvaro

family: Baumgartner

full_name: Iris Baumgartner

given: Iris

family: Budaj

full_name: Andrzej J. Budaj

given: Andrzej J.

family: Chen

full_name: Jyh-Hong Chen

given: Jyh-Hong

family: Dans

full_name: Antonio L. Dans

given: Antonio L.

family: Darius

full_name: Harald Darius

given: Harald

family: Di Pasquale

full_name: Giuseppe Di Pasquale

given: Giuseppe

family: Ferreira

full_name: Jorge Ferreira

given: Jorge

family: Flaker

full_name: Greg C. Flaker

given: Greg C.

family: Flather

full_name: Marcus D. Flather

given: Marcus D.

family: Franzosi

full_name: Maria Grazia Franzosi

given: Maria Grazia

family: Golitsyn

full_name: Sergey P. Golitsyn

given: Sergey P.

family: Halon

full_name: David A. Halon

given: David A.

family: Heidbuchel

full_name: Hein Heidbuchel

given: Hein

family: Hohnloser

full_name: Stefan H. Hohnloser

given: Stefan H.

publisher: Ovid Technologies (Wolters Kluwer Health)

location_country:
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
India
France
Poland
Thailand
Slovakia
Norway
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Philippines
Switzerland
Bulgaria
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel

location_facility: 1160.71.0951 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0056 Boehringer Ingelheim Investigational Site

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location_facility: 1160.71.1018 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0410 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1683 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1108 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0214 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1471 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0859 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0356 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0819 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0254 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0133 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0680 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1422 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0397 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0255 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0349 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0333 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0398 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0198 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0295 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0008 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0310 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0431 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0395 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0466 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0052 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0135 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0696 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0203 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0119 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0384 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0550 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1057 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0705 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1459 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0110 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1424 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1423 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1397 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0436 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0697 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0672 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0376 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0784 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1120 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1291 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0932 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1109 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0235 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0150 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0777 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0194 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1100 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0020 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1672 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1436 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0062 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0615 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0249 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0032 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0646 Boehringer Ingelheim Investigational Site

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location_facility: 1160.71.0452 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0394 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1745 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0274 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1062 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0311 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1361 Boehringer Ingelheim Investigational Site

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location_facility: 1160.71.1169 Boehringer Ingelheim Investigational Site

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location_facility: 1160.71.1581 Boehringer Ingelheim Investigational Site

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location_facility: 1160.71.0811 Boehringer Ingelheim Investigational Site

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location_facility: 1160.71.879H Boehringer Ingelheim Investigational Site

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location_facility: 1160.71.0433 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0453 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0563 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0612 Boehringer Ingelheim Investigational Site

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location_facility: 1160.71.1751 Boehringer Ingelheim Investigational Site

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location_facility: 1160.71.0543 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0701 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0213 Boehringer Ingelheim Investigational Site

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location_facility: 1160.71.0072 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0308 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0690 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0168 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0818 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0064 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0675 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1626 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1755 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0710 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0069 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1101 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0113 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0679 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1391 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0185 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0018 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1748 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0142 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.879C Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1012 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0904 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0839 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0364 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0501 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0285 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0945 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1343 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.1052 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0858 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0699 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0944 Boehringer Ingelheim Investigational Site

location_facility: 1160.71.0177 Boehringer Ingelheim Investigational Site

title: RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed the RE-LY Trial and a Cluster Randomised Trial to Assess the Effect of a Knowledge Translation Intervention on Patient Outcomes

summary:
The purposes of this study are:

To evaluate the long-term safety of dabigatran etexilate
To assess the effect of a knowledge translation intervention on patient outcomes


ReferenceType: background

ReferenceCitation: Golan T, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algül H, O'Reilly EM, McGuinness D, Cui KY, Schlienger K, Locker GY, Kindler HL. Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer. N Engl J Med. 2019 Jul 25;381(4):317-327. doi: 10.1056/NEJMoa1903387. Epub 2019 Jun 2.

ReferenceCitation: Li N, Zheng H, Huang Y, Zheng B, Cai H, Liu M. Cost-Effectiveness Analysis of Olaparib Maintenance Treatment for Germline BRCA-Mutated Metastatic Pancreatic Cancer. Front Pharmacol. 2021 Apr 20;12:632818. doi: 10.3389/fphar.2021.632818. eCollection 2021.

family: Li

full_name: Na Li

family: Zheng

full_name: Huanrui Zheng

given: Huanrui

family: Huang

full_name: Yanlei Huang

given: Yanlei

full_name: Bin Zheng

given: Bin

family: Cai

full_name: Hongfu Cai

given: Hongfu

family: Liu

full_name: Maobai Liu

given: Maobai

currency_apc_doaj: USD

journal_name: Frontiers in Pharmacology

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ReferenceCitation: Zhan M, Zheng H, Yang Y, He Z, Xu T, Li Q. Cost-Effectiveness Analysis of Maintenance Olaparib in Patients with Metastatic Pancreatic Cancer and a Germline BRCA1/2 Mutation Based on the POLO Trial. Cancer Manag Res. 2020 Dec 16;12:12919-12926. doi: 10.2147/CMAR.S283169. eCollection 2020.

family: Zhan

full_name: Mei Zhan

given: Mei

full_name: Hanrui Zheng

given: Hanrui

family: Yang

full_name: Yu Yang

given: Yu

family: He

full_name: Zhiyao He

given: Zhiyao

family: Xu

full_name: Ting Xu

given: Ting

full_name: Qiu Li

given: Qiu

journal_name: Cancer Management and Research

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Golan T, Kindler HL, Park JO, Reni M, Macarulla T, Hammel P, Van Cutsem E, Arnold D, Hochhauser D, McGuinness D, Locker GY, Goranova T, Schatz P, Liu YZ, Hall MJ. Geographic and Ethnic Heterogeneity of Germline BRCA1 or BRCA2 Mutation Prevalence Among Patients With Metastatic Pancreatic Cancer Screened for Entry Into the POLO Trial. J Clin Oncol. 2020 May 1;38(13):1442-1454. doi: 10.1200/JCO.19.01890. Epub 2020 Feb 19.

name: The Oncology Institute, Sheba Medical Center at Tel-Hashomer, Tel Aviv University, Tel Aviv, Israel

family: Golan

full_name: Talia Golan

given: Talia

family: Kindler

name: Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

name: IRCCS Ospedale San Raffaele Scientific Institute, Milan, Italy

name: Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona, Spain

name: Hôpital Beaujon (AP-HP), Clichy, and University Paris VII, Paris, France

name: University Hospitals Gasthuisberg, Leuven, and KU Leuven, Leuven, Belgium

name: Asklepios Tumorzentrum Hamburg AK Altona, Hamburg, Germany

name: University College London Cancer Institute, London, United Kingdom

name: Fox Chase Cancer Center, Philadelphia, PA

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Hammel P, Kindler HL, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algül H, O'Reilly EM, McGuinness D, Cui KY, Joo S, Yoo HK, Patel N, Golan T; POLO Investigators. Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib. Ann Oncol. 2019 Dec 1;30(12):1959-1968. doi: 10.1093/annonc/mdz406.

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

repository_institution: University College London - UCL Discovery

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

repositories:
LIRIAS (KU Leuven)
PubMed Central
UCL Discovery
recercat.cat

ReferenceCitation: Lowery MA, Kelsen DP, Capanu M, Smith SC, Lee JW, Stadler ZK, Moore MJ, Kindler HL, Golan T, Segal A, Maynard H, Hollywood E, Moynahan M, Salo-Mullen EE, Do RKG, Chen AP, Yu KH, Tang LH, O'Reilly EM. Phase II trial of veliparib in patients with previously treated BRCA-mutated pancreas ductal adenocarcinoma. Eur J Cancer. 2018 Jan;89:19-26. doi: 10.1016/j.ejca.2017.11.004. Epub 2017 Dec 8.

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

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

title: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy

summary: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy


title: A Phase III Clinical Trial of BBI608 Plus Weekly Paclitaxel vs. Placebo Plus Weekly Paclitaxel in Adult Patients With Advanced, Previously Treated Gastric and Gastro-Esophageal Junction Adenocarcinoma

acronym: BRIGHTER

summary: The purpose of this study is to find out whether it is better to receive a new drug, BBI608, in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as second line treatment for gastric and gastroesophageal junction cancer after prior first line platinum and fluoropyrimidine based chemotherapy.

lead_sponsor: Sumitomo Dainippon Pharma Oncology, Inc

location_country:
Romania
Belgium
Australia
Russian Federation
France
Japan
Lithuania
Poland
Canada
Korea, Republic of
Bulgaria
Hungary
China
Germany
United States
United Kingdom
Italy
Brazil
Czechia
Israel
Spain
Estonia

location_facility: Southern Medical University, Nanfang Hospital

location_facility: AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can

location_facility: Institut Català d'Oncologia-Hospital Germans Trias i Pujol

location_facility: Ballarat Oncology and Haematology Services

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: The 81 Hospital of the Chinese People's Liberation Army

location_facility: Tartu University Hospital Clinic of Hematology and Oncology

location_facility: Hospital of Lithuanian University of Health Sciences

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Instituto do Câncer do Ceará - Instituto do Câncer do Cear

location_facility: Multiprofile hospital for active treatment

location_facility: East Tallinn Central Hospital Oncology Center

location_facility: First Pavlov State Medical University of Saint-Petersburg

location_facility: McGill University Health Centre - Montreal General Hospital

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Centre Hospitalier De Mont De Marsan - Hopital Layné

location_facility: UMHAT ""Dr. Georgi Stranski"" Dept. Medical Oncology

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko

location_facility: Charite - Campus Benjamin Franklin (Cbf)

location_facility: Magodent sp. z o.o. Szpital Onkologiczny

location_facility: Egyesített Szent István és Szent László Kórház-Rendelőintéze

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: The University of Oklahoma Health Sciences Center (OUHSC)

location_facility: UPCO - Unidade de Pesquisa Clinica em Oncologia LTDA

location_facility: The First Bethune Hospital of Jilin University

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

location_facility: Azienda Ospedaliera Fatebenefratelli e Oftalmico

location_facility: State University of New York Upstate Medical University

location_facility: Uni. Multiprofile Hospital for Active treatment Sveta Marina

location_facility: Northern Indiana Cancer Research Consortium

location_facility: Indiana University Health University Hospital

location_facility: Hospital de Base de São José do Rio Preto

location_facility: Northwestern State Medical University n.a. Mechnikov

location_facility: New Hampshire Oncology Hematology - Concord

location_facility: The E. Wolfson Medical Center [Oncology]

location_facility: Vilniaus Universiteto ligonines Santariskiu Klinikos

location_facility: Sp. Jud. de Urg. "Dr. Constantin Opris" Baia Mare

location_facility: Hospital of Lithuanian University of Health sciences

location_facility: Military Medical Academy n.a. S.M. Kirov

location_facility: New Hampshire Oncology Hematology - Laconia

location_facility: Indiana University Health Goshen Center For Cancer Care

location_facility: Saint Michael's Hospital Li Ka Shing Knowledge Institute

location_facility: Radiotherapy Center CJ radioterapie si chimioterapie adulti

location_facility: IRCCS Ospedale Oncologico "Giovanni Paolo II"

location_facility: Unità di Biostatistica e Sperimentazioni Cliniche IRST

location_facility: The 307th Hospital of Chinese People's Liberation Army

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház- Rendelőinté

location_facility: Azienda Ospedaliera "Istituti Ospitalieri" di Cremona

location_facility: Szpital Specjalistyczny im. L. Rydygiera w Krakowie

location_facility: Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc

location_facility: Seoul National University Bundang Hospital

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Ospedale Molinette, AO Città della Salute e della Scienza di

location_facility: Sunshine Coast Hospital and Health Service

location_facility: Saku Central Hospital Advanced Care Center

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: SPb State Budget Institution Oncology Dispansery

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital

location_facility: GBUZ Saint Petersburg clinical scientific and practical cent

location_facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung

location_facility: General Hospital of Ningxia Medical University

location_facility: GBUZ of Stavropol Territory Pyatigorsk Oncology Dispensary

location_facility: Harbin Medical University Cancer Hospital

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Weill Medical College of Cornell University

location_facility: The First Hospital of China Medical University

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

location_facility: Xin Jiang Tumor Hospital, Xin Jiang Medical University

location_facility: NZOZ Centrum Medyczne HCP Lecznictwo Stacjonarne

location_facility: District Dispensery with Stationary - Sofia District

location_facility: Kobe City Medical Center General Hospital

location_facility: Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna

location_facility: Ospedale Guglielmo da Saliceto, AUSL Piacenza

location_facility: Swedish Cancer Institute/ Swedish Health Services

location_facility: Specialised Hospital for Active Treatment in Oncology

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: Fujian Medical University Union Hospital

location_facility: Wojewodzki Szpital Specjalistyczny im. M.Kopernika

location_facility: The Beatson West Of Scotland Cancer Centre

location_facility: Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital

location_facility: Russian Oncological Research Center n.a. N.N. Blokhin RAMS

intervention_type: Other

status_simplified: Completed


title: Prospective Observational Study of Febrile Neutropenia (FN) and Pegfilgrastim Primary Prophylaxis in Breast Cancer and Non-Hodgkin's Lymphoma Patients Receiving High (>20%) FN-risk Chemotherapy

summary: To estimate the incidence of febrile neutropenia in patients with breast cancer and non-Hodgkin's lymphoma receiving high (> 20%) FN-risk chemotherapy and pegfilgrastim primary prophylaxis.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Amgen

location_country: Austria France Czechia Bulgaria Greece Poland Romania Belgium Germany


title: Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT

acronym: CLEPSYDRA

summary: This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD).

primary_purpose: Diagnostic

lead_sponsor: LivaNova

location_country:
Italy
United States
Switzerland
Netherlands
France
Spain
Germany
United Kingdom
Canada

location_facility:
Dr. Defaye
Dr. Kolb
Pr. Weiss
Pr. Brachmann
Dr. Peinado
Dr. Brugada
Dr Fluck - Dr. Beeton
Pr. Bauer
Dr. Fleck - Dr. Goetze
Dr. Bru
Dr. Beiras
Pr. Sadoul
Drs. John Fisher, Jay Gross
Dr. Pisapia
Dr. Ritter
Dr. Butter
Pr. Davy
Drs. Lewis, Garg
Dr. Burban
Drs. Thibualt, Guerra
Dr Abbey
Dr. Morgan
Dr. Bonnemeier
Dr. Delay
Drs. Jagmeet Singh, Kevin, Hiest
Dr. Leyva
Pr. Kacet
Pr. Mabo
Dr. Vogt
Dr. Gold
Dr. NG
Dr. Wieckhorst
Dr. Dupuis
Dr. Murgatroyd
Dr. Klein - Dr. Oswald
Pr. Da Costa
Dr. Delnoy
Pr. Eckhardt
Dr. Champagne, Dr. Philippon
Dr Mantovan
Dr Auricchio
Pr. Anselme
Pr. Mewis - Pr. Fröhlig
Dr. Leonardo Calo
Dr. Schlegl
Dr. Martinez
Dr. Haines
Dr. Sperzel
Dr. Bowes
Dr. Jauvert

intervention_type: Device


ReferenceCitation: Rimassa L, Assenat E, Peck-Radosavljevic M, Pracht M, Zagonel V, Mathurin P, Rota Caremoli E, Porta C, Daniele B, Bolondi L, Mazzaferro V, Harris W, Damjanov N, Pastorelli D, Reig M, Knox J, Negri F, Trojan J, López López C, Personeni N, Decaens T, Dupuy M, Sieghart W, Abbadessa G, Schwartz B, Lamar M, Goldberg T, Shuster D, Santoro A, Bruix J. Tivantinib for second-line treatment of MET-high, advanced hepatocellular carcinoma (METIV-HCC): a final analysis of a phase 3, randomised, placebo-controlled study. Lancet Oncol. 2018 May;19(5):682-693. doi: 10.1016/S1470-2045(18)30146-3. Epub 2018 Apr 3.

family: Rimassa

full_name: Lorenza Rimassa

given: Lorenza

family: Assenat

full_name: Eric Assenat

given: Eric

family: Peck-Radosavljevic

full_name: Markus Peck-Radosavljevic

given: Markus

family: Pracht

full_name: Marc Pracht

given: Marc

family: Zagonel

full_name: Vittorina Zagonel

given: Vittorina

family: Mathurin

full_name: Philippe Mathurin

given: Philippe

family: Rota Caremoli

full_name: Elena Rota Caremoli

given: Elena

family: Porta

full_name: Camillo Porta

given: Camillo

family: Daniele

full_name: Bruno Daniele

given: Bruno

family: Bolondi

full_name: Luigi Bolondi

given: Luigi

family: Mazzaferro

full_name: Vincenzo Mazzaferro

given: Vincenzo

family: Harris

full_name: William Harris

given: William

family: Damjanov

full_name: Nevena Damjanov

given: Nevena

family: Pastorelli

full_name: Davide Pastorelli

given: Davide

family: Reig

full_name: María Reig

given: María

family: Knox

full_name: Jennifer Knox

given: Jennifer

family: Negri

full_name: Francesca Negri

given: Francesca

family: Trojan

full_name: Jörg Trojan

given: Jörg

family: López López

full_name: Carlos López López

given: Carlos

family: Personeni

full_name: Nicola Personeni

given: Nicola

family: Decaens

full_name: Thomas Decaens

given: Thomas

family: Dupuy

full_name: Marie Dupuy

given: Marie

family: Sieghart

full_name: Wolfgang Sieghart

given: Wolfgang

family: Abbadessa

full_name: Giovanni Abbadessa

given: Giovanni

family: Schwartz

full_name: Brian Schwartz

given: Brian

location_country:
Italy
Austria
Brazil
Sweden
Switzerland
Netherlands
Spain
Germany
France
Argentina
Australia
Belgium
New Zealand
United States
Canada
Portugal

title: A Phase 3, Randomized, Double-Blind Study of Tivantinib (ARQ 197) in Subjects With MET Diagnostic-High Inoperable Hepatocellular Carcinoma Treated With One Prior Systemic Therapy

summary: The purpose of this study is to determine if tivantinib (ARQ 197) is effective in treating patients with MET diagnostic-high hepatocellular carcinoma (liver cancer) who have already been treated once with another therapy.


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG102) With Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

summary: This is a phase 3, multicenter, randomized, double-blind, placebo controlled study of epirubicin, cisplatin & capecitabine (ECX) with rilotumumab or placebo for untreated advanced MET-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma

status: Terminated

ReferenceCitation: Catenacci DVT, Tebbutt NC, Davidenko I, Murad AM, Al-Batran SE, Ilson DH, Tjulandin S, Gotovkin E, Karaszewska B, Bondarenko I, Tejani MA, Udrea AA, Tehfe M, De Vita F, Turkington C, Tang R, Ang A, Zhang Y, Hoang T, Sidhu R, Cunningham D. Rilotumumab plus epirubicin, cisplatin, and capecitabine as first-line therapy in advanced MET-positive gastric or gastro-oesophageal junction cancer (RILOMET-1): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Nov;18(11):1467-1482. doi: 10.1016/S1470-2045(17)30566-1. Epub 2017 Sep 25.

family: Catenacci

full_name: Daniel V T Catenacci

given: Daniel V T

family: Tebbutt

full_name: Niall C Tebbutt

given: Niall C

family: Davidenko

full_name: Irina Davidenko

given: Irina

family: Murad

full_name: André M Murad

given: André M

family: Al-Batran

full_name: Salah-Eddin Al-Batran

given: Salah-Eddin

family: Ilson

full_name: David H Ilson

given: David H

family: Tjulandin

full_name: Sergei Tjulandin

given: Sergei

family: Gotovkin

full_name: Evengy Gotovkin

given: Evengy

family: Karaszewska

full_name: Boguslawa Karaszewska

given: Boguslawa

family: Bondarenko

full_name: Igor Bondarenko

given: Igor

family: Tejani

full_name: Mohamedtaki A Tejani

given: Mohamedtaki A

family: Udrea

full_name: Anghel A Udrea

given: Anghel A

family: Tehfe

full_name: Mustapha Tehfe

given: Mustapha

family: De Vita

full_name: Ferdinando De Vita

given: Ferdinando

family: Turkington

full_name: Cheryl Turkington

given: Cheryl

family: Tang

full_name: Rui Tang

given: Rui

family: Ang

full_name: Agnes Ang

given: Agnes

family: Zhang

full_name: Yilong Zhang

given: Yilong

family: Hoang

full_name: Tien Hoang

given: Tien

family: Sidhu

full_name: Roger Sidhu

given: Roger

family: Cunningham

full_name: David Cunningham

given: David

journal_name: The Lancet Oncology

oa_host_type: repository

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

ReferenceCitation: Doshi S, Gisleskog PO, Zhang Y, Zhu M, Oliner KS, Loh E, Perez Ruixo JJ. Rilotumumab exposure-response relationship in patients with advanced or metastatic gastric cancer. Clin Cancer Res. 2015 Jun 1;21(11):2453-61. doi: 10.1158/1078-0432.CCR-14-1661. Epub 2015 Feb 24.

publisher: American Association for Cancer Research (AACR)

title: Rilotumumab Exposure–Response Relationship in Patients with Advanced or Metastatic Gastric Cancer

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Ukraine
France
Poland
Slovakia
Canada
South Africa
Sweden
Switzerland
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Spain
Turkey


title: An International, Multi-Center Study Evaluating the Correlation of IL28B Genotypes With Patient Demographics and Disease Characteristics in Patients With Chronic Hepatitis C

summary: This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes with disease characteristics and demographics in treatment-naïve and treatment-experienced chronic hepatitis C patients, including patients with HIV co-infection. There will be a single study visit for testing.

design_allocation: Non-Randomized

lead_sponsor: Hoffmann-La Roche

location_country: Macedonia, The Former Yugoslav Republic of


title: Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D

acronym: RESPOND-CRT

summary:
The objective of this study is to assess the safety and effectiveness of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device (Model 9770) in combination with the SonRtip Lead, which includes a SonR sensor in the tip of the atrial pacing lead, and compatible SmartView programming software.

This study will evaluate the effectiveness of the automatic optimization algorithm in increasing the rate of patients responding to the therapy as compared to an echocardiographic optimization method.

This study will also evaluate the safety and effectiveness of the SonRtip atrial pacing lead.

status: Unknown status

ReferenceCitation: Brugada J, Delnoy PP, Brachmann J, Reynolds D, Padeletti L, Noelker G, Kantipudi C, Rubin Lopez JM, Dichtl W, Borri-Brunetto A, Verhees L, Ritter P, Singh JP; RESPOND CRT Investigators. Contractility sensor-guided optimization of cardiac resynchronization therapy: results from the RESPOND-CRT trial. Eur Heart J. 2017 Mar 7;38(10):730-738. doi: 10.1093/eurheartj/ehw526.

family: Brugada

full_name: Josep Brugada

given: Josep

family: Delnoy

full_name: Peter Paul Delnoy

given: Peter Paul

family: Brachmann

full_name: Johannes Brachmann

given: Johannes

family: Reynolds

full_name: Dwight Reynolds

given: Dwight

family: Padeletti

full_name: Luigi Padeletti

given: Luigi

family: Noelker

full_name: Georg Noelker

given: Georg

family: Kantipudi

full_name: Charan Kantipudi

given: Charan

family: Rubin Lopez

full_name: José Manuel Rubin Lopez

given: José Manuel

family: Dichtl

full_name: Wolfgang Dichtl

given: Wolfgang

family: Borri-Brunetto

full_name: Alberto Borri-Brunetto

given: Alberto

family: Verhees

full_name: Luc Verhees

given: Luc

family: Ritter

full_name: Philippe Ritter

given: Philippe

family: Singh

full_name: Jagmeet P. Singh

given: Jagmeet P.

journal_name: European Heart Journal

oa_colors: green hybrid

repository_institution: PubMed Central - Europe PMC

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

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Brugada J, Brachmann J, Delnoy PP, Padeletti L, Reynolds D, Ritter P, Borri-Brunetto A, Singh JP. Automatic optimization of cardiac resynchronization therapy using SonR-rationale and design of the clinical trial of the SonRtip lead and automatic AV-VV optimization algorithm in the paradym RF SonR CRT-D (RESPOND CRT) trial. Am Heart J. 2014 Apr;167(4):429-36. doi: 10.1016/j.ahj.2013.12.007. Epub 2013 Dec 19. Review.

title: Automatic Optimization of Cardiac Resynchronization Therapy Using SonR—Rationale and Design of the Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the Paradym RF SonR CRT-D (RESPOND CRT) Trial

location_country:
Italy
Austria
Switzerland
Netherlands
Spain
Germany
United Kingdom
France
Australia
Portugal
United States
Slovenia

location_facility: KH Hietzing,4. Medizinische Abteilung Mit Kardiologie

location_facility: Hospital Professor Doutor Fernando Fonseca

location_facility: Herz- und Diabeteszentrum Nordrhein-Westfalen

location_facility: Brookwood Medical Center CardioVascular Associates

location_facility: Kardiocentrum Frankfurt and der Klinik Rotes Kreuz

location_facility: Centro Hospitalar do Porto CHP Hospital de Santo Antonio

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)

location_facility: Ashford and St. Peter's Hospitals NHS Trust

location_facility: Lkh Innsbruck - Invasoren Kardiologie - Innere Medizin

location_facility: A.O. Città della Salute e della Scienza di Torino Cardiologia 1 - U

location_facility: CHU de Bordeaux, Groupe hospitalier Sud, Hôpital Haut-L'évêque

location_facility: Azienda Ospedaliera S. Anna e S. Sebastiano

location_facility: Universitätsklinik Münster Innere Medizin C

location_facility: Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO)

location_facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti di Trieste

location_facility: King's College Hospital NHS Foundation Trust

location_facility: A.O. Città della Salute e della Scienza di Torino Cardiologia 2 ospedaliera

location_facility: Hospital General Universitario de Alicante

location_facility: Castle Hill Hospital Hull and East Yorkshire Hospitals NHS T

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Providence Cardiology d/b/a South Caroline Heart Center

location_facility: Az. Osp. Univ. S. Maria della Misericordia

location_facility: Az. Osp-Univ. Ospedali Riuniti Umberto I-Lancisi-Salesi

location_facility: Centre Hospitalier Universitaire de La Timone

location_facility: The University of Chicago Medicine Hospital

location_facility: Hospital Universitario Marques de Valdecilla Sur


title: A Long-Term Follow-up Study of Subjects Who Participated in a Clinical Trial in Which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Was Administered for the Treatment of Chronic Hepatitis C

summary: The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) and achieved sustained virologic response.

enrollment_type: Anticipated

ReferenceCitation: Reddy KR, Pol S, Thuluvath PJ, Kumada H, Toyota J, Chayama K, Levin J, Lawitz EJ, Gadano A, Ghesquiere W, Gerken G, Brunetto MR, Peng CY, Silva M, Strasser SI, Heo J, McPhee F, Liu Z, Yang R, Linaberry M, Noviello S. Long-term follow-up of clinical trial patients treated for chronic HCV infection with daclatasvir-based regimens. Liver Int. 2018 May;38(5):821-833. doi: 10.1111/liv.13596. Epub 2017 Oct 12.

name: School of Medicine; University of Pennsylvania; Philadelphia PN USA

family: Reddy

full_name: K. Rajender Reddy

given: K. Rajender

family: Pol

full_name: Stanislas Pol

given: Stanislas

family: Thuluvath

full_name: Paul J. Thuluvath

given: Paul J.

family: Kumada

full_name: Hiromitsu Kumada

given: Hiromitsu

name: Sapporo-Kosei General Hospital; Sapporo Japan

family: Toyota

full_name: Joji Toyota

given: Joji

family: Chayama

full_name: Kazuaki Chayama

given: Kazuaki

family: Levin

full_name: James Levin

given: James

name: Texas Liver Institute; University of Texas Health Sciences Center; San Antonio TX USA

family: Lawitz

full_name: Eric J. Lawitz

given: Eric J.

name: Hospital Italiano de Buenos Aires; Buenos Aires Argentina

family: Gadano

full_name: Adrian Gadano

given: Adrian

name: Vancouver Island Health Authority; University of British Columbia; Victoria BC Canada

family: Ghesquiere

full_name: Wayne Ghesquiere

given: Wayne

name: University of Duisburg-Essen; Essen Germany

family: Gerken

full_name: Guido Gerken

given: Guido

name: Department of Clinical and Experimental Medicine; University of Pisa; Pisa Italy

family: Brunetto

full_name: Maurizia R. Brunetto

given: Maurizia R.

name: School of Medicine; China Medical University; Taichung Taiwan

family: Peng

full_name: Cheng-Yuan Peng

given: Cheng-Yuan

name: Hospital Universitario Austral; Buenos Aires Argentina

family: Silva

full_name: Marcelo Silva

given: Marcelo

name: Royal Prince Alfred Hospital; Sydney NSW Australia

family: Strasser

full_name: Simone I. Strasser

given: Simone I.

name: College of Medicine; Medical Research Institute; Pusan National University Hospital; Pusan National University; Busan Korea

family: Heo

full_name: Jeong Heo

given: Jeong

name: Bristol-Myers Squibb; Wallingford CT USA

family: McPhee

full_name: Fiona McPhee

given: Fiona

family: Liu

full_name: Zhaohui Liu

given: Zhaohui

family: Yang

full_name: Rong Yang

given: Rong

family: Linaberry

full_name: Misti Linaberry

given: Misti

family: Noviello

full_name: Stephanie Noviello

given: Stephanie

journal_name: Liver International

location_country:
Italy
Brazil
United States
Sweden
Mexico
Germany
France
Japan
Poland
Ireland
Argentina
Australia
Puerto Rico
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Alabama Liver & Digestive Specialists (Alds)

location_facility: Bon Secours St. Mary's Hospital of Richmond, Inc.

location_facility: Instituto Centralizado De Asistencia E Investigacion Clinica

location_facility: University Of Colorado Denver & Hospital

location_facility: University Of Pennsylvania School Of Medicine

location_facility: University Of North Carolina At Chapel Hill School Of Med


title: A Phase III Study to Demonstrate the Antiviral Activity and Safety of Dolutegravir in HIV-1 Infected Adult Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

summary: The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults with current or historical failure on an integrase inhibitor (INI) containing regimen. The study will assess DTG 50mg twice daily administered initially with the current failing ART regimen but then with an optimised background ART regimen (OBR) after Day 7. The first analyses will be conducted after the last subject enrolled has completed 24 weeks. Subjects may remain on study after Week 24.

ReferenceCitation: Eron JJ, Clotet B, Durant J, Katlama C, Kumar P, Lazzarin A, Poizot-Martin I, Richmond G, Soriano V, Ait-Khaled M, Fujiwara T, Huang J, Min S, Vavro C, Yeo J; VIKING Study Group. Safety and efficacy of dolutegravir in treatment-experienced subjects with raltegravir-resistant HIV type 1 infection: 24-week results of the VIKING Study. J Infect Dis. 2013 Mar 1;207(5):740-8. doi: 10.1093/infdis/jis750. Epub 2012 Dec 7.

ReferenceCitation: Castagna A, Maggiolo F, Penco G, Wright D, Mills A, Grossberg R, Molina JM, Chas J, Durant J, Moreno S, Doroana M, Ait-Khaled M, Huang J, Min S, Song I, Vavro C, Nichols G, Yeo JM; VIKING-3 Study Group. Dolutegravir in antiretroviral-experienced patients with raltegravir- and/or elvitegravir-resistant HIV-1: 24-week results of the phase III VIKING-3 study. J Infect Dis. 2014 Aug 1;210(3):354-62. doi: 10.1093/infdis/jiu051. Epub 2014 Jan 19.

family: Castagna

full_name: A. Castagna

given: A.

family: Maggiolo

full_name: F. Maggiolo

given: F.

family: Penco

full_name: G. Penco

given: G.

family: Wright

full_name: D. Wright

given: D.

family: Mills

full_name: A. Mills

family: Grossberg

full_name: R. Grossberg

given: R.

family: Molina

full_name: J.-M. Molina

family: Chas

full_name: J. Chas

given: J.

family: Durant

full_name: J. Durant

family: Moreno

full_name: S. Moreno

given: S.

family: Doroana

full_name: M. Doroana

given: M.

family: Ait-Khaled

full_name: M. Ait-Khaled

family: Huang

full_name: J. Huang

family: Min

full_name: S. Min

family: Song

full_name: I. Song

given: I.

family: Vavro

full_name: C. Vavro

given: C.

family: Nichols

full_name: G. Nichols

family: Yeo

full_name: J. M. Yeo

given: J. M.

family: Aberg

full_name: J. Aberg

family: Akil

full_name: B. Akil

given: B.

family: Arribas

full_name: J. R. Arribas

given: J. R.

family: Baril

full_name: J.- G. Baril

family: Blanco Arevalo

full_name: J. L. Blanco Arevalo

given: J. L.

family: Blanco Quintana

full_name: F. Blanco Quintana

repository_institution: The Pennsylvania State University - CiteSeer X

repositories:
CiteSeerX
PubMed Central
pdfs.semanticscholar.org

title: Dolutegravir in Antiretroviral-Experienced Patients With Raltegravir- and/or Elvitegravir-Resistant HIV-1: 24-Week Results of the Phase III VIKING-3 Study

location_country:
Italy
United States
Spain
France
Belgium
Portugal
Canada