lead_sponsor: United Therapeutics

location_country:
Italy
Austria
United States
Sweden
India
Mexico
Netherlands
Germany
Spain
France
Poland
Israel
Ireland
Australia
Belgium
Puerto Rico
China
Canada
United Kingdom
Portugal

acronym: FREEDOM-EXT

location_facility: University of Colorado Health Science Center

location_facility: Pulmonary Hypertension Unit Centre for Lung Health Mater Misericordiae University Hospital

location_facility: Asian Heart Institute & Research Centre Pvt. Ltd.

location_facility: University of Arizona Clinical and Translational Science (CATS) Research Center

location_facility: Servico de Cardiologia Hospital de Santa Marta

location_facility: University of Minnesota Medical Center, Fairview

location_facility: University of Iowa Hospitals and Clinics

location_facility: CHU Arnaud de Villeneuve - Service maladies respiratoires

location_facility: Dept. of Internal Medicine III University Heidelberg

location_facility: London Health Sciences Center Victoria Hospital

location_facility: Hospital of the University of Pennsylvania

location_facility: Centre d'Investigation Clinique Hôpital La Cavale Blanche - CHU Brest

location_facility: Life Care Institute of Medical Sciences & Research

location_facility: Radboud University Nijmegen Medical Center

location_facility: University of Florida College of Medicine Jacksonville

location_facility: Service de Pneumologie Centre de Competence pour l'HTAP- Pole des Voies Respiratoires Hôpital Larrey

location_facility: Beijing Shijitan Hospital, Cadres Respiratory Department

location_facility: Dipartimento di Scienze Cardiovascolari, Respiratorie e Morfologiche

location_facility: University of California San Francisco Medical Center

location_facility: Azienda Ospedaliera di Rilievo Nazionale Monaldi - Cotugno-CTO Cardiologia S.U.N.

location_facility: Shanghai Pulmonary Hospital, Respiratory Medicine Department

location_facility: Vancouver Coastal Health Authority Vancouver General Hospital

location_facility: Pulmonary Institute Chaim Sheba Medical Center

location_facility: Peking Union Medical College Hospital, Respiratory Medicine Department

location_facility: The Carl and Ethyl Linder Center for Research and Education at the Christ Church

location_facility: Washington University School of Medicine

location_facility: Universitaetsklinik für Innere Medizin Innsbruck

location_facility: Stanford University, Pulmonary and Critical Care Medicine

location_facility: Auxilio Mutuo Hospital CardioPulmonary Research Center

location_facility: Sri Ramachandra Medical College & Research Institute

location_facility: Universitätsklinkium Köln Klinik III für Innere Medizin

location_facility: Service Chirurgie Thoracique, Hôpital Haut Levêque

location_facility: Unidad de Investigacion Clinica en Medicina S.C.

location_facility: Pulmonary Institute Rabin Medical Center (Belinson Kampus)

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: Hadassah Hebrew University Medical Center

location_facility: Department of Cardiology Erasme University Hospital

location_facility: Universitätsklinikum Dresden Abtl. Pneumologie

location_facility: Heart/Lung Transplant Unit - St. Vincent's Hospital

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Zentrum für Lungenhochdruck Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: Policlinico S. Orsola Malpighi - Università degli studi di Bologna

location_facility: University of California, San Francisco-Fresno

ipd_sharing: No

title: An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension

summary: This study provided/continued to provide oral treprostinil (UT-15C SR; treprostinil diethanolamine) to eligible subjects who participated in Studies TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, and TDE-PH-308. The study assessed the long term safety of oral treprostinil and the effect of continued treatment with oral treprostinil on exercise capacity after 1 year of treatment.


ReferenceType: derived

ReferenceCitation: Fajgenbaum DC, Uldrick TS, Bagg A, Frank D, Wu D, Srkalovic G, Simpson D, Liu AY, Menke D, Chandrakasan S, Lechowicz MJ, Wong RS, Pierson S, Paessler M, Rossi JF, Ide M, Ruth J, Croglio M, Suarez A, Krymskaya V, Chadburn A, Colleoni G, Nasta S, Jayanthan R, Nabel CS, Casper C, Dispenzieri A, Fosså A, Kelleher D, Kurzrock R, Voorhees P, Dogan A, Yoshizaki K, van Rhee F, Oksenhendler E, Jaffe ES, Elenitoba-Johnson KS, Lim MS. International, evidence-based consensus diagnostic criteria for HHV-8-negative/idiopathic multicentric Castleman disease. Blood. 2017 Mar 23;129(12):1646-1657. doi: 10.1182/blood-2016-10-746933. Epub 2017 Jan 13.

name: Division of Translational Medicine and Human Genetics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA;

family: Fajgenbaum

full_name: David C. Fajgenbaum

given: David C.

sequence: first

name: National Cancer Institute, National Institutes of Health, Bethesda, MD;

family: Uldrick

full_name: Thomas S. Uldrick

given: Thomas S.

sequence: additional

name: Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA;

family: Bagg

full_name: Adam Bagg

given: Adam

family: Frank

full_name: Dale Frank

given: Dale

name: Department of Laboratory Medicine, University of Washington, Seattle, WA;

family: Wu

full_name: David Wu

given: David

name: Sparrow Cancer Center, Edward W. Sparrow Hospital Association, Lansing, MI;

family: Srkalovic

full_name: Gordan Srkalovic

given: Gordan

name: Division of Haematology, North Shore Hospital, Auckland, New Zealand;

family: Simpson

full_name: David Simpson

family: Liu

full_name: Amy Y. Liu

given: Amy Y.

name: Division of Hematology, Department of Medicine, and Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN;

family: Menke

full_name: David Menke

name: Department of Medicine, Emory University School of Medicine, Atlanta, GA;

family: Chandrakasan

full_name: Shanmuganathan Chandrakasan

given: Shanmuganathan

family: Lechowicz

full_name: Mary Jo Lechowicz

given: Mary Jo

name: Sir Y.K. Pao Centre for Cancer and Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong;

family: Wong

full_name: Raymond S. M. Wong

given: Raymond S. M.

family: Pierson

full_name: Sheila Pierson

given: Sheila

name: Department of Pathology, Children’s Hospital of Philadelphia, Philadelphia, PA;

family: Paessler

full_name: Michele Paessler

given: Michele

name: Department of Hematology, Hôpital Saint Éloi University Hospital, Montpellier, France;

family: Rossi

full_name: Jean-François Rossi

given: Jean-François

name: Department of Hematology, Takamatsu Red Cross Hospital, Takamatsu, Kagawa, Japan;

family: Ide

full_name: Makoto Ide

given: Makoto

name: Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA;

family: Ruth

full_name: Jason Ruth

given: Jason

name: School of Medicine, Stony Brook University, Stony Brook, NY;

family: Croglio

full_name: Michael Croglio

given: Michael

family: Suarez

full_name: Alexander Suarez

given: Alexander

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

family: Krymskaya

full_name: Vera Krymskaya

given: Vera

name: Department of Pathology, Weill Cornell Medical College, New York, NY;

family: Chadburn

full_name: Amy Chadburn

given: Amy

name: Departamento de Oncologia Clínica e Experimental, Universidade Federal de São Paulo, São Paulo, Brazil;

family: Colleoni

full_name: Gisele Colleoni

given: Gisele

name: Division of Hematology/Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA;

family: Nasta

full_name: Sunita Nasta

given: Sunita

name: Department of Pediatrics, Texas Children’s Hospital, Houston, TX;

family: Jayanthan

full_name: Raj Jayanthan

given: Raj

name: Department of Medicine, Brigham and Women’s Hospital, Boston, MA;

family: Nabel

full_name: Christopher S. Nabel

given: Christopher S.

name: Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA;

name: Division of Hematology/Oncology, Mayo Clinic, Rochester, MN;

name: Department of Oncology, Oslo University Hospital–Norwegian Radium Hospital, Oslo, Norway;

name: Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada;

name: Center for Personalized Therapy and Clinical Trials Office, UC San Diego Moores Cancer Center, La Jolla, CA;

name: Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute, Carolinas HealthCare System, Charlotte, NC;

name: Departments of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY;

name: Department of Organic Fine Chemicals, The Institute of Scientific and Industrial Research, Osaka University, Osaka, Japan;

name: Myeloma Institute, University of Arkansas for Medical Sciences, Little Rock, AR; and

name: Department of Clinical Immunology, Hôpital Saint-Louis, Paris, France

title: International, evidence-based consensus diagnostic criteria for HHV-8–negative/idiopathic multicentric Castleman disease

ReferenceCitation: van Rhee F, Wong RS, Munshi N, Rossi JF, Ke XY, Fosså A, Simpson D, Capra M, Liu T, Hsieh RK, Goh YT, Zhu J, Cho SG, Ren H, Cavet J, Bandekar R, Rothman M, Puchalski TA, Reddy M, van de Velde H, Vermeulen J, Casper C. Siltuximab for multicentric Castleman's disease: a randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2014 Aug;15(9):966-74. doi: 10.1016/S1470-2045(14)70319-5. Epub 2014 Jul 17. Erratum in: Lancet Oncol. 2014 Sep;15(10):417.

location_country:
Malaysia
Belgium
Australia
Russian Federation
Taiwan
India
France
Norway
Canada
Korea, Republic of
Hong Kong
Netherlands
Singapore
Hungary
China
United States
Germany
United Kingdom
Brazil
Israel
Egypt
Spain
New Zealand

title: A Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of CNTO 328 (Anti IL 6 Monoclonal Antibody) Plus Best Supportive Care Compared With Best Supportive Care in Subjects With Multicentric Castleman's Disease

summary: The purpose of this study is to demonstrate that CNTO 328 when administered in combination with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic response (complete response or partial response) among patients with Multicentric Castleman's Disease.


ReferenceCitation: André F, O'Regan R, Ozguroglu M, Toi M, Xu B, Jerusalem G, Masuda N, Wilks S, Arena F, Isaacs C, Yap YS, Papai Z, Lang I, Armstrong A, Lerzo G, White M, Shen K, Litton J, Chen D, Zhang Y, Ali S, Taran T, Gianni L. Everolimus for women with trastuzumab-resistant, HER2-positive, advanced breast cancer (BOLERO-3): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2014 May;15(6):580-91. doi: 10.1016/S1470-2045(14)70138-X. Epub 2014 Apr 14.

family: André

full_name: Fabrice André

given: Fabrice

family: O'Regan

full_name: Ruth O'Regan

given: Ruth

family: Ozguroglu

full_name: Mustafa Ozguroglu

given: Mustafa

family: Toi

full_name: Masakazu Toi

given: Masakazu

family: Xu

full_name: Binghe Xu

given: Binghe

family: Jerusalem

full_name: Guy Jerusalem

given: Guy

family: Masuda

full_name: Norikazu Masuda

given: Norikazu

family: Wilks

full_name: Sharon Wilks

given: Sharon

family: Arena

full_name: Francis Arena

given: Francis

family: Isaacs

full_name: Claudine Isaacs

given: Claudine

family: Yap

full_name: Yoon-Sim Yap

given: Yoon-Sim

family: Papai

full_name: Zsuzsanna Papai

given: Zsuzsanna

family: Lang

full_name: Istvan Lang

given: Istvan

family: Armstrong

full_name: Anne Armstrong

given: Anne

family: Lerzo

full_name: Guillermo Lerzo

given: Guillermo

family: White

full_name: Michelle White

given: Michelle

family: Shen

full_name: Kunwei Shen

given: Kunwei

family: Litton

full_name: Jennifer Litton

given: Jennifer

family: Chen

full_name: David Chen

given: David

family: Zhang

full_name: Yufen Zhang

given: Yufen

family: Ali

full_name: Shyanne Ali

given: Shyanne

family: Taran

full_name: Tetiana Taran

given: Tetiana

family: Gianni

full_name: Luca Gianni

given: Luca

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

location_country:
Greece
Belgium
Australia
Czech Republic
Thailand
France
Japan
Poland
Slovakia
Argentina
Singapore
Hungary
China
Germany
United Kingdom
United States
Italy
Mexico
Israel
Spain
Turkey

location_facility: University of Pittsburgh Cancer Institute DeptofMageeWomen'sHospital(2)

location_facility: Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)

location_facility: South Texas Oncology and Hematology, PA South Texas Oncology (2)

location_facility: MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2)

location_facility: Nevada Cancer Institute Dept. of Nevada Cancer (3)

location_facility: Swedish Cancer Institute Swedish Cancer Institute

location_facility: Overlook Hospital - Carol G Simon Cancer Center Carol G Simon

location_facility: University of Texas Southwestern Medical Center University of TX SW Med Ctr(2)

location_facility: Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

location_facility: Virginia Oncology Associates Dept. of VOA (2)

location_facility: University of Arizona / Cancer Center Deptof Uof A/Arizona Cancer(3)

location_facility: Memorial Hospital Memorial Cancer Institute

location_facility: North Shore University Health System NSU

location_facility: Texas Cancer Center ( Medical City Dallas Hospital) Dept. of Texas Cancer Ctr. (2)

location_facility: The Jones Clinic Dept .of The Jones Clinic (3)

location_facility: Comprehensive Cancer Center - Boca Raton Deerfield Beach

location_facility: Comprehensive Cancer Center - Boca Raton Dept.of BocaRatonCompCanCtr

location_facility: Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)

location_facility: Georgetown University/Lombardi Cancer Center Dept.of Lombardi CancerCtr (3)

location_facility: University of California San Diego - Moores Cancer Center La Jolla - UCSD Moores Cancer

location_facility: Duke University Medical Center Dept. of DUMC (2)

location_facility: Park Nicollet Institute Dept. of Park Nicollet

location_facility: University of Texas/MD Anderson Cancer Center SC-5

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2)

location_facility: Florida Cancer Specialists DeptofFloridaCancerSpecialists

location_facility: Virginia Cancer Specialists Fairfax No.VA (2)

location_facility: St. Louis University Cancer Center SLU Cancer Center

location_facility: Longview Cancer Center Longview Cancer Center (2)

location_facility: Texas Oncology Presbyterian Hospital (2)

location_facility: Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)

location_facility: University of Nebraska Medical Center Unv Nebraska Med Ctr (2)

location_facility: Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(6)

location_facility: Kansas City Cancer Center KCCC- South (2)

location_facility: University of Arizona / Cancer Center AZ Onc Assoc

title: A Randomized Phase III, Double-blind, Placebo-controlled Multicenter Trial of Daily Everolimus in Combination With Trastuzumab and Vinorelbine, in Pretreated Women With HER2/Neu Over-expressing Locally Advanced or Metastatic Breast Cancer.

summary: This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanced or metastatic breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane.


type: Other Identifier

title: A Randomized Phase 3 Study of Tasisulam-sodium Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle Versus Paclitaxel as Second-line Treatment in Patients With Metastatic Melanoma

summary: The primary purpose of this study was to see how tasisulam-sodium affected metastatic melanoma when compared against paclitaxel as measured by overall survival.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Austria
United States
Sweden
Netherlands
Germany
Finland
France
Poland
Israel
Norway
Australia
Belgium
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


type: EudraCT Number

title: Comparison of Transdermal Fentanyl PCA and IV Morphine PCA in the Management of Postoperative Pain Control

acronym: EuroTrans

summary: The purpose of this study is to evaluate the effectiveness and safety of a patient-controlled system to deliver fentanyl compared with a patient-controlled intravenous system to deliver morphine in the management of postoperative pain.

status: Completed

ReferenceType: result

ReferenceCitation: Grond S, Hall J, Spacek A, Hoppenbrouwers M, Richarz U, Bonnet F. Iontophoretic transdermal system using fentanyl compared with patient-controlled intravenous analgesia using morphine for postoperative pain management. Br J Anaesth. 2007 Jun;98(6):806-15. Erratum in: Br J Anaesth. 2008 Jan;100(1):146.

lead_sponsor: Janssen-Cilag International NV

location_country:
Austria
Sweden
Switzerland
France
Ireland
Belgium
Spain
Denmark
Germany
United Kingdom

status_simplified: Completed


ReferenceCitation: Andermann E, Rosenfeld W, Penovich P, Rogin J, Cendes F, Carreño M, Ramsay RE, Ben-Menachem E, Gama H, Rocha F, Soares-da-Silva P, Tosiello R, Blum D, Grinnell T. Comparative analysis of the safety and tolerability of eslicarbazepine acetate in older (≥60 years) and younger (18-59 years) adults. Epilepsy Res. 2021 Jan;169:106478. doi: 10.1016/j.eplepsyres.2020.106478. Epub 2020 Oct 10.

family: Andermann

full_name: Eva Andermann

given: Eva

family: Rosenfeld

full_name: William Rosenfeld

given: William

family: Penovich

full_name: Patricia Penovich

given: Patricia

family: Rogin

full_name: Joanne Rogin

given: Joanne

family: Cendes

full_name: Fernando Cendes

given: Fernando

family: Carreño

full_name: Mar Carreño

given: Mar

family: Ramsay

full_name: R. Eugene Ramsay

given: R. Eugene

family: Ben-Menachem

full_name: Elinor Ben-Menachem

given: Elinor

family: Gama

full_name: Helena Gama

given: Helena

family: Rocha

full_name: Francisco Rocha

given: Francisco

family: Soares-da-Silva

full_name: Patrício Soares-da-Silva

given: Patrício

family: Tosiello

full_name: Robert Tosiello

given: Robert

family: Blum

full_name: David Blum

family: Grinnell

full_name: Todd Grinnell

given: Todd

journal_name: Epilepsy Research

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Comparative analysis of the safety and tolerability of eslicarbazepine acetate in older (≥60 years) and younger (18–59 years) adults

ReferenceCitation: Cramer JA, Colman S, Anastassopoulos KP, Grinnell T, Mehta D, Williams GR. Associations between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life in patients with focal seizures treated with adjunctive eslicarbazepine acetate: Post hoc analyses of clinical trial results. Epilepsy Behav. 2020 Nov;112:107312. doi: 10.1016/j.yebeh.2020.107312. Epub 2020 Aug 12.

family: Cramer

full_name: Joyce A. Cramer

given: Joyce A.

family: Colman

full_name: Sam Colman

given: Sam

family: Anastassopoulos

full_name: Kathryn P. Anastassopoulos

given: Kathryn P.

family: Mehta

full_name: Darshan Mehta

given: Darshan

family: Williams

full_name: G. Rhys Williams

given: G. Rhys

location_country:
Italy
United States
Brazil
Germany
Cyprus
France
Poland
Greece
Belgium
Argentina
Canada

location_facility: Hospital Privado de la comunidad de Mar de Plata

location_facility: University of South Florida - Department of Neurology

location_facility: NZOZ "NEURO - KARD,"Ilkowski I Partnerzy Spólka, Partnerska Lekarzy

location_facility: Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna

location_facility: Wiell Cornell Medical Centre Epilepsy Centre

location_facility: Centro Neurológico de Tratamiento y Rehabilitación

location_facility: Hopital Femme-Mere-Enfant, Hospices Civils de Lyon

location_facility: Dean & St. Mary's Outpatient Center Neurological Institute and Spine Center

location_facility: University of Arizona Health Sciences Center

location_facility: Università Cattolica del Sacro Cuore Policlinico "A. Gemelli"

location_facility: Barrow Neurological Institute / St. Joseph's Hospital and Medical Center

location_facility: Università degli Studi di Napoli Policlinico Federico II

location_facility: Josephson Wallack Munshower Neurology P.C.

location_facility: Charite, Universitätsmedizin Berlin, CVK

location_facility: Azienda Ospedaliero, Universitaria "Ospedali Riuniti", Clinica della Malattie del Sistema Nervoso, Università di Foggia

location_facility: Sentara Medical Group, Neurology Specialists Sentara Heart Hospital

location_facility: Consultants in Epilepsy and Neurology, PPLC

location_facility: Regional Epilepsy Centre of Aurora Healthcare- St. Luke's Medical Centre

location_facility: Medical College of Wisconsin - Department of Neurology

location_facility: Comprehensive Epilepsy Center - Thomas Jefferson University

location_facility: UMDNJ-Robert Wood Johnson Medical School

location_facility: Neurological Associates of Washington/Clinical Trials of America, Inc

location_facility: University of Virginia - Comprehensive Epilepsy Program

location_facility: General Hospital of Thessaloniki "Papanikolaou"

location_facility: Hopital Gui de Chauliac, Chu de Montpellier

location_facility: Wojewódzki Szpital Specjalistyczny w Lublinie Oddzial Neurologii

location_facility: Klinik und Poliklinik für Neurologie der Universität Regensburg im Bezirksklinikum

location_facility: Phoenix Neurological Associates/Clinical Research Advantage

location_facility: MGH Epilepsy Service Massachusetts, General Hospital

location_facility: UTSWMC Department of Neurology, Division of Epilepsy Research

location_facility: Azienda Ospedaliero - Universitaria Maggiore della Carità

location_facility: Wojewódzki Szpital Specjalistyczny w Olsztynie, Oddzial Neurologii

location_facility: University of South Alabama Department of Neurology

location_facility: University of Calgary Clinical Neurosciences

location_facility: University of Miami - Miller School of Medicine Department of Neurology

location_facility: Childrens Hospital of Pittsburg of UPMC - Division of Child Neurology

location_facility: Centro de Neurologia y Neurorehabilitacion

location_facility: Azienda Universitatia Ospedaliera San Giovanni Battista

location_facility: Hospital Privado - Centro Médico de Córdoba S.A.

location_facility: Strong Epilepsy Center - University of Rochester Medical Center

location_facility: Santa Casa de Misericórdia de Belo Horizonte

location_facility: Montreal Neurological Institute and Hospital

location_facility: Pediatric Epilepsy & Neurology Specialists, PA

location_facility: The Comprehensive Epilepsy Care Centre for Chidren and Adults

location_facility: 21st Century Neurology - Division of Xenoscience, Inc.

location_facility: Temple University School of Medicine - Department of Neurology

location_facility: Palm Beach Clinical Research Network, LLC.

location_facility: Epilepsie-Zentrum Berlin Brandenburg am Evangelischen Krankenhaus Königin Elisabeth Herzberge

location_facility: CENTRE HOSPITALIER PELLEGRIN, CHU de BORDEAUX

location_facility: Irmandade da Santa Casa de Misericórdia de São Paulo

location_facility: Southern Ilinois University School of Medicine

location_facility: Klinik für Neurologie, Klinische Neurophysiologie und Stroke Unit

location_facility: University Washington Regional Epilepsy Center Harborview

location_facility: Wayne State University/Detroit Medical Center

location_facility: Kern County Neurological Medical Group, INC.

location_facility: Albany Medical College - Neurosciences Institute

location_facility: Scott and White Memorial Hospital Sherwood and Brindley Foundation

location_facility: University of Toledo - Health Science Campus

location_facility: University of Florida Department of Neurology

title: Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures in a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Trial

summary: The purpose of this study is to determine whether Eslicarbazepine acetate (BIA 2-093) is an effective adjunct therapy in the treatment of refractory partial seizures


ReferenceCitation: Worden F, Fassnacht M, Shi Y, Hadjieva T, Bonichon F, Gao M, Fugazzola L, Ando Y, Hasegawa Y, Park DJ, Shong YK, Smit JW, Chung J, Kappeler C, Meinhardt G, Schlumberger M, Brose MS. Safety and tolerability of sorafenib in patients with radioiodine-refractory thyroid cancer. Endocr Relat Cancer. 2015 Dec;22(6):877-87. doi: 10.1530/ERC-15-0252.

family: Worden

full_name: Francis Worden

given: Francis

family: Fassnacht

full_name: Martin Fassnacht

given: Martin

family: Shi

full_name: Yuankai Shi

given: Yuankai

family: Hadjieva

full_name: Tatiana Hadjieva

given: Tatiana

family: Bonichon

full_name: Françoise Bonichon

given: Françoise

family: Gao

full_name: Ming Gao

given: Ming

family: Fugazzola

full_name: Laura Fugazzola

given: Laura

family: Ando

full_name: Yuichi Ando

given: Yuichi

family: Hasegawa

full_name: Yasuhisa Hasegawa

given: Yasuhisa

family: Park

full_name: Do Joon Park

given: Do Joon

family: Shong

full_name: Young Kee Shong

given: Young Kee

family: Smit

full_name: Johannes W A Smit

given: Johannes W A

family: Chung

full_name: John Chung

given: John

family: Kappeler

full_name: Christian Kappeler

given: Christian

family: Meinhardt

full_name: Gerold Meinhardt

given: Gerold

family: Schlumberger

full_name: Martin Schlumberger

family: Brose

full_name: Marcia S Brose

given: Marcia S

journal_name: Endocrine-Related Cancer

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

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

version: submittedVersion

evidence: oa repository (semantic scholar lookup)

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

ReferenceCitation: Brose MS, Nutting CM, Jarzab B, Elisei R, Siena S, Bastholt L, de la Fouchardiere C, Pacini F, Paschke R, Shong YK, Sherman SI, Smit JW, Chung J, Kappeler C, Peña C, Molnár I, Schlumberger MJ; DECISION investigators. Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial. Lancet. 2014 Jul 26;384(9940):319-28. doi: 10.1016/S0140-6736(14)60421-9. Epub 2014 Apr 24.

ReferenceCitation: Brose MS, Nutting CM, Sherman SI, Shong YK, Smit JW, Reike G, Chung J, Kalmus J, Kappeler C, Schlumberger M. Rationale and design of decision: a double-blind, randomized, placebo-controlled phase III trial evaluating the efficacy and safety of sorafenib in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory, differentiated thyroid cancer. BMC Cancer. 2011 Aug 11;11:349. doi: 10.1186/1471-2407-11-349.

title: Rationale and design of DECISION: a double-blind, randomized, placebo-controlled phase III trial evaluating the efficacy and safety of sorafenib in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory, differentiated thyroid cancer

ReferenceCitation: Brose MS, Schlumbeger M, Jeffers M, Kappeler C, Meinhardt G, Peña CEA. Analysis of Biomarkers and Association With Clinical Outcomes in Patients With Differentiated Thyroid Cancer: Subanalysis of the Sorafenib Phase III DECISION Trial. Clin Cancer Res. 2019 Dec 15;25(24):7370-7380. doi: 10.1158/1078-0432.CCR-18-3439. Epub 2019 Sep 26.

publisher: American Association for Cancer Research (AACR)

ReferenceCitation: Capdevila J, Matos I, Mancuso FM, Iglesias C, Nuciforo P, Zafon C, Palmer HG, Ogbah Z, Muiños L, Hernando J, Villacampa G, Peña CE, Tabernero J, Brose MS, Schlumberger M, Vivancos A. Identification of Expression Profiles Defining Distinct Prognostic Subsets of Radioactive-Iodine Refractory Differentiated Thyroid Cancer from the DECISION Trial. Mol Cancer Ther. 2020 Jan;19(1):312-317. doi: 10.1158/1535-7163.MCT-19-0211. Epub 2019 Sep 20.

location_country:
Italy
Austria
Sweden
Saudi Arabia
Netherlands
Spain
Germany
France
Bulgaria
Japan
Poland
Belgium
Russian Federation
China
Denmark
United States
United Kingdom
Korea, Republic of

title: A Double-Blind Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

summary: Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine


ReferenceCitation: Cordonnier C, Ljungman P, Juergens C, Maertens J, Selleslag D, Sundaraiyer V, Giardina PC, Clarke K, Gruber WC, Scott DA, Schmoele-Thoma B; 3003 Study Group. Immunogenicity, safety, and tolerability of 13-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal polysaccharide vaccine in recipients of allogeneic hematopoietic stem cell transplant aged ≥2 years: an open-label study. Clin Infect Dis. 2015 Aug 1;61(3):313-23. doi: 10.1093/cid/civ287. Epub 2015 Apr 13.

family: Cordonnier

full_name: Catherine Cordonnier

given: Catherine

family: Ljungman

full_name: Per Ljungman

given: Per

family: Juergens

full_name: Christine Juergens

given: Christine

family: Maertens

full_name: Johan Maertens

given: Johan

family: Selleslag

full_name: Dominik Selleslag

given: Dominik

family: Sundaraiyer

full_name: Vani Sundaraiyer

given: Vani

family: Giardina

full_name: Peter C. Giardina

given: Peter C.

family: Clarke

full_name: Keri Clarke

given: Keri

family: Gruber

full_name: William C. Gruber

given: William C.

family: Scott

full_name: Daniel A. Scott

given: Daniel A.

family: Schmoele-Thoma

full_name: Beate Schmoele-Thoma

given: Beate

journal_name: Clinical Infectious Diseases

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central
pdfs.semanticscholar.org

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Immunogenicity, Safety, and Tolerability of 13-Valent Pneumococcal Conjugate Vaccine Followed by 23-Valent Pneumococcal Polysaccharide Vaccine in Recipients of Allogeneic Hematopoietic Stem Cell Transplant Aged ≥2 Years: An Open-Label Study

design_allocation: Non-Randomized

intervention_type: Biological

study_start_date_type: Actual

lead_sponsor: Pfizer

primary_purpose: Prevention

location_country:
United States
Sweden
Netherlands
Germany
France
Czechia
Poland
Belgium
Spain
Canada

location_facility: Universitetssjukhuset i Lund, Barnonkologen Avd 64

location_facility: New York-Presbyterian Morgan Stanley Children's Hospital

location_facility: Fakultni nemocnice Brno/Interni hematoonkologicka klinika

location_facility: Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej

location_facility: Universitaire Ziekenhuizen Leuven (UZ) Gasthuisberg

location_facility: Columbia University Medical Center-Presbyterian Hospital Building

location_facility: Hopital Robert Debre - Service Pharmacie

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Hospital Universitario Infantil Niño Jesús

location_facility: Klinik und Poliklinik fuer Paediatrische Haematologie und Onkologie

location_facility: Columbia University Medical Center Research Pharmacy

location_facility: UMC Utrecht, Wilhelmina Kinder Ziekenhuis

location_facility: Universitaetsklinikum Hamburg-Eppendorf, Onkologisches Zentrum

location_facility: Universitaetsklinikum Hamburg Eppendorf Clinical Trial Center North MediGate GmbH

location_facility: Columbia University/Taub Institute Irving Center for Clinical Research

location_facility: Steven and Alexandra Cohen Children's Medical Center of New York

source: euctr

title: A Phase 3, Open-label Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Followed By 23-valent Pneumococcal Polysaccharide Vaccine In Recipients Of Allogeneic Hematopoietic Stem Cell Transplant Aged 2 Years And Older

summary: People who have received an allogeneic hematopoetic stem cell transplant (HSCT) are more likely than other people to get ill from a germ called Streptococcus pneumoniae. Most people who have had a stem cell transplant are offered a vaccine called 23-valent pneumococcal polysaccharide vaccine (23vPS) to help protect against this germ. The purpose of this study is to evaluate the immune response in HSCT recipients who receive a 13 valent pneumococcal vaccine (13vPnC) followed by 23vPS.


lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Brazil
United States
Mexico
Germany
France
Thailand
Argentina
Australia
Russian Federation
Spain
Canada

location_facility: Cedars Sinai Medical Center The Pituitary Center (3)

location_facility: Dana Farber Cancer Institute Deptof DanaFarberCancerInst(5)

location_facility: Mount Sinai School of Medicine Study Coordinator

location_facility: Swedish Medical Center Dept.ofSwedishMedicalCtr.(2)

location_facility: Cedars Sinai Medical Center Cedars Sinai 4

title: An Open Label, Multicenter, Single Arm Study of Pasireotide LAR in Patients With Rare Tumors of Neuroendocrine Origin

summary: This study will assess the effectiveness and safety of pasireotide long-acting release in patients who have rare tumors of neuroendocrine origin.


title: A Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Endovascular Coiling.

summary:
The aim of this study is to demonstrate that clazosentan, administered as a continuous intravenous infusion at either 5 mg/h or 15 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH), reduces the incidence of cerebral vasospasm-related morbidity and all-cause mortality within 6 weeks post-aSAH treated by endovascular coiling.

The primary endpoint of the study is the occurrence of cerebral vasospasm-related morbidity, and mortality of all-causes within 6 weeks post-aSAH, defined by at least one of the following:

Death (all causes).
New cerebral infarct(s) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm.
Delayed ischemic neurological deficit (DIND) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm.
Administration of a valid rescue therapy in the presence of confirmed cerebral vasospasm on angiography (DSA or CTA).

An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet the primary endpoint and its individual morbidity components.

ReferenceCitation: Macdonald RL, Higashida RT, Keller E, Mayer SA, Molyneux A, Raabe A, Vajkoczy P, Wanke I, Bach D, Frey A, Nowbakht P, Roux S, Kassell N. Randomized trial of clazosentan in patients with aneurysmal subarachnoid hemorrhage undergoing endovascular coiling. Stroke. 2012 Jun;43(6):1463-9. doi: 10.1161/STROKEAHA.111.648980. Epub 2012 Mar 8. Erratum in: Stroke. 2012 Jul;43(7):e68.

name: From the St. Michael's Hospital University Toronto (R.L.M.), Toronto, ON, Canada; University of California (R.T.H.), San Francisco Medical Center, San Francisco, CA; University of Zürich (E.K.), Zürich, Switzerland; Columbia University (S.A.M.), New York, NY; University of Oxford (A.M.), Oxford, UK; University of Bern (A.R.), Bern, Switzerland; Charite Universitaetsmedizin Berlin (P.V.), Berlin, Germany; University Hospital of Essen (I.W.), Essen, Germany; Klinik Hirslanden (I.W.), Zürich,...

family: Macdonald

full_name: R. Loch Macdonald

given: R. Loch

family: Higashida

full_name: Randall T. Higashida

given: Randall T.

family: Keller

full_name: Emanuela Keller

given: Emanuela

family: Mayer

full_name: Stephan A. Mayer

given: Stephan A.

family: Molyneux

full_name: Andy Molyneux

given: Andy

family: Raabe

full_name: Andreas Raabe

given: Andreas

family: Vajkoczy

full_name: Peter Vajkoczy

given: Peter

family: Wanke

full_name: Isabel Wanke

given: Isabel

family: Bach

full_name: Doris Bach

given: Doris

family: Frey

full_name: Aline Frey

given: Aline

family: Nowbakht

full_name: Pegah Nowbakht

given: Pegah

family: Roux

full_name: Sébastien Roux

given: Sébastien

family: Kassell

full_name: Neal Kassell

given: Neal

journal_name: Stroke

evidence: open (via free pdf)

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Randomized Trial of Clazosentan in Patients With Aneurysmal Subarachnoid Hemorrhage Undergoing Endovascular Coiling

ReferenceCitation: Mayer SA, Aldrich EF, Bruder N, Hmissi A, Macdonald RL, Viarasilpa T, Marr A, Roux S, Higashida RT. Thick and Diffuse Subarachnoid Blood as a Treatment Effect Modifier of Clazosentan After Subarachnoid Hemorrhage. Stroke. 2019 Oct;50(10):2738-2744. doi: 10.1161/STROKEAHA.119.025682. Epub 2019 Aug 9.

name: From the Department of Neurology, Henry Ford Hospital, Detroit, MI (S.A.M., T.V.)

name: University of Maryland, Baltimore (E.F.A.)

family: Aldrich

full_name: E. Francois Aldrich

given: E. Francois

name: Hopital de la Timone-Aix-Marseille Université, France (N.B.)

family: Bruder

full_name: Nicolas Bruder

given: Nicolas

name: Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland (A.H., A.M., S.R.)

family: Hmissi

full_name: Abdel Hmissi

given: Abdel

name: Division of Neurosurgery, Department of Surgery, St. Michael’s Hospital, University of Toronto, ON, Canada (R.L.M.)

name: Division of Critical Care, Department of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand (T.V.)

family: Viarasilpa

full_name: Tanuwong Viarasilpa

name: University of California San Francisco Medical Center (R.T.H.).

location_country:
Finland
Australia
Belgium
Denmark
Taiwan
India
France
Poland
Norway
Argentina
Canada
Slovenia
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
Germany
United States
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain

location_facility: State University of New York at Stony Brook

location_facility: University of Szeged, Faculty of Medicine

location_facility: Hospital Clinico Pontificia Universidad Católica de Chile

location_facility: Azienda Osepedaliera San Giovanni - Addolorata

location_facility: Neurochirurggische Universitatsklinik des Heidelberg

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

location_facility: University of Texas Southwestern Zale Lipshy Hospital

location_facility: Virginia Commonwealth University Medical Centre

location_facility: Borsod-Abauj-Zemplen County Hospital and University Teaching Hospital

location_facility: AKH University of Vienna, Medical Univ. Of Neurosurgery

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczy w Warszawie

location_facility: University Fur Neurochirurgie, SALK, Christian Doppler Hospital

location_facility: Hospital de Clinicas da Universidade Federal do Parana

location_facility: Klinik und Poliklinik fur Neurochirurgie

location_facility: Universitatsklinik Frankfurt, Klinik und Poliklinik f. Neurochirurgie

location_facility: Thomas Jefferson University School of Medicine

location_facility: Instituto Nacional de Neurologia y Neurocirugia

location_facility: Landeskrankenhaus und Medizinische Universitat

location_facility: Neuroradiologie der Universitatsklinik Freiburg

location_facility: University of Pecs, Faculty of Medicine Neurosurgery Clinic

location_facility: Complejo Hospotalario Virgen de las Nieves-Hospital de Rehabilitacion y Traumatologia

location_facility: Haukeland University Hospital, Helse Bergen HF

location_facility: University Hospitals Case Medical Center

location_facility: University of Calgary - Foothills Medical Center

location_facility: St. Michael's Hospital, University of Toronto

location_facility: QEII Heath Sciences Center - Halifax Infirmary

location_facility: Klinik imd Poliklinik fur Neurochirurgie

location_facility: New York Presbyteruan Hospital - Weill Cornell Medical Centre

location_facility: Tampere University Central Hospital (TAYS)

location_facility: Oklahoma University Health Sciences Center

location_facility: Universitatsklinikum Augsburg Clinic for Diagnostic Radiology and Neuroradiology

location_facility: Thechnical University - Klinikum rechts der Isar

location_facility: Universitaet Erlangen-Nuerberg Klinik fur Neurologie

location_facility: Hopital neurologique et Neuro-Chirurgical Pierre Wertheimer

location_facility: Capital Health System Inc. d/b/a The Stroke and Cerebrovascular Center of New Jersey

location_facility: Post Graduate Institute of Medical Education and Research

location_facility: The Neuroscience Center, Copenhagen University Hospital


type: Registry Identifier

title: TK008: Randomized Phase III Trial of Haploidentical HCT With or Without an Add Back Strategy of HSV-Tk Donor Lymphocytes in Patients With High Risk Acute Leukemia

summary: The main objective of this randomized trial is to compare disease-free survival (DFS) in high risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of HSV-Tk donor lymphocytes or standard haploidentical HCT

ipd_sharing_description: No, only information requested by law will be released

lead_sponsor: AGC Biologics S.p.A.

location_country:
Italy
United States
Spain
France
Greece
Israel
Lithuania
Belgium
Portugal
Germany

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: IUCT Oncopole - Institut Universitaire du Cancer de Toulouse

location_facility: Azienda Ospedaliero-Universitaria Policlinico-Vittorio Emanuele

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Presidio Molinette

location_facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

location_facility: Policlinico G. B. Rossi, Azienda ospedaliera universitaria integrata di Verona

location_facility: Azienda Sanitaria Ospedaliera S.Croce e Carle

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena

intervention_type: Other


ReferenceCitation: Vaduganathan M, Cheema B, Cleveland E, Sankar K, Subacius H, Fonarow GC, Solomon SD, Lewis EF, Greene SJ, Maggioni AP, Böhm M, Zannad F, Butler J, Gheorghiade M. Plasma renin activity, response to aliskiren, and clinical outcomes in patients hospitalized for heart failure: the ASTRONAUT trial. Eur J Heart Fail. 2018 Apr;20(4):677-686. doi: 10.1002/ejhf.973. Epub 2017 Nov 16.

name: Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School; Boston MA USA

family: Vaduganathan

full_name: Muthiah Vaduganathan

given: Muthiah

family: Cheema

full_name: Baljash Cheema

given: Baljash

family: Cleveland

full_name: Erin Cleveland

given: Erin

family: Sankar

full_name: Kamya Sankar

given: Kamya

family: Subacius

full_name: Haris Subacius

given: Haris

name: Ahmanson-UCLA Cardiomyopathy Center; University of California Los Angeles; Los Angeles CA USA

family: Fonarow

full_name: Gregg C. Fonarow

given: Gregg C.

family: Solomon

full_name: Scott D. Solomon

given: Scott D.

family: Lewis

full_name: Eldrin F. Lewis

given: Eldrin F.

family: Greene

full_name: Stephen J. Greene

given: Stephen J.

family: Maggioni

full_name: Aldo P. Maggioni

given: Aldo P.

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

family: Böhm

full_name: Michael Böhm

given: Michael

name: INSERM, CHRU Nancy; Université de Lorraine, Centre d'Investigation Clinique CIC1433; Nancy France

family: Zannad

full_name: Faiez Zannad

given: Faiez

family: Butler

full_name: Javed Butler

given: Javed

name: Center for Cardiovascular Innovation; Northwestern University, Feinberg School of Medicine; Chicago IL USA

family: Gheorghiade

full_name: Mihai Gheorghiade

given: Mihai

journal_name: European Journal of Heart Failure

evidence: open (via free article)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Greene SJ, Butler J, Fonarow GC, Subacius HP, Ambrosy AP, Vaduganathan M, Triggiani M, Solomon SD, Lewis EF, Maggioni AP, Böhm M, Chioncel O, Nodari S, Senni M, Zannad F, Gheorghiade M; ASTRONAUT Investigators and Coordinators. Pre-discharge and early post-discharge troponin elevation among patients hospitalized for heart failure with reduced ejection fraction: findings from the ASTRONAUT trial. Eur J Heart Fail. 2018 Feb;20(2):281-291. doi: 10.1002/ejhf.1019. Epub 2017 Oct 17.

name: Duke Clinical Research Institute and Division of Cardiology; Duke University Medical Center; Durham NC USA

name: Division of Cardiology; Stony Brook University; Stony Brook NY USA

name: Center for Cardiovascular Innovation; Northwestern University Feinberg School of Medicine; Chicago IL USA

full_name: Haris P. Subacius

given: Haris P.

name: Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical Center; Boston MA USA

name: Cardiology Section, Department of Clinical and Surgical Specialties, Radiological Sciences and Public Health; University of Brescia; Brescia Italy

name: Italian Association of Hospital Cardiologists, ANMCO Research Center; Florence Italy

name: Klinik für Innere Medizin III; Universitätsklinikum des Saarlandes; Homburg/Saar Germany

name: Institute of Emergency for Cardiovascular Diseases Professor C. C. Iliescu; University of Medicine and Pharmacy Carol Davila; Bucharest Romania

name: Division of Cardiology 1; Papa Giovanni XXIII Hospital; Bergamo Italy

name: Inserm, Clinical Investigation Center CIC 1433; Université de Lorraine and CHRU Nancy; France

name: for the ASTRONAUT Investigators and Coordinators

ReferenceCitation: Lund LH, Trochu JN, Meyns B, Caliskan K, Shaw S, Schmitto JD, Schibilsky D, Damme L, Heatley J, Gustafsson F. Screening for heart transplantation and left ventricular assist system: results from the ScrEEning for advanced Heart Failure treatment (SEE-HF) study. Eur J Heart Fail. 2018 Jan;20(1):152-160. doi: 10.1002/ejhf.975. Epub 2017 Sep 27.

name: Department of Medicine; Karolinska Institutet; Stockholm Sweden

name: Department of Cardiology; Karolinska University Hospital; Stockholm Sweden

name: Institut du Thorax, Inserm UMR 1087-CIC1413; Centre Hospitalier Universaire de Nantes; Nantes France

name: Erasmus MC University Medical Center; Rotterdam The Netherlands

name: University Hospital of S. Manchester NHS Trust; Manchester UK

name: Department of Cardiac, Thoracic, Transplantation and Vascular Surgery; Hannover Medical School; Hannover Germany

name: German Heart Competance Center; University Clinical Center Tuebingen; Tuebingen Germany

name: Department of Cardiology; Copenhagen University Hospital Rigshospitalet; Copenhagen Denmark

ReferenceCitation: Gheorghiade M, Böhm M, Greene SJ, Fonarow GC, Lewis EF, Zannad F, Solomon SD, Baschiera F, Botha J, Hua TA, Gimpelewicz CR, Jaumont X, Lesogor A, Maggioni AP; ASTRONAUT Investigators and Coordinators. Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: the ASTRONAUT randomized trial. JAMA. 2013 Mar 20;309(11):1125-35. doi: 10.1001/jama.2013.1954. Erratum in: JAMA. 2013 Apr 10;309(14):1461.

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

title: Effect of Aliskiren on Postdischarge Mortality and Heart Failure Readmissions Among Patients Hospitalized for Heart Failure

ReferenceCitation: Gheorghiade M, Albaghdadi M, Zannad F, Fonarow GC, Böhm M, Gimpelewicz C, Botha J, Moores S, Lewis EF, Rattunde H, Maggioni A; ASTRONAUT investigators and study coordinators. Rationale and design of the multicentre, randomized, double-blind, placebo-controlled Aliskiren Trial on Acute Heart Failure Outcomes (ASTRONAUT). Eur J Heart Fail. 2011 Jan;13(1):100-6. doi: 10.1093/eurjhf/hfq209. Epub 2010 Nov 30.

name: Center for Cardiovascular Innovation; Northwestern University Feinberg School of Medicine; 645 N. Michigan Avenue, Suite 1006 Chicago IL 60611 USA

name: Clinical Investigation Center INSERM-CHU de Nancy Hôpital Jeanne d'Arc; Dommartin-les Toul Cedex France

name: Cardiovascular Division; Brigham and Women's Hospital; Boston MA USA

name: Associazione Nazionale Medici Cardiologi Ospedalieri Research Center; Florence Italy

name: on behalf of the ASTRONAUT investigators and study coordinators

location_country:
Finland
Romania
Belgium
Russian Federation
Czech Republic
Taiwan
India
France
Poland
Slovakia
Argentina
Canada
Colombia
Sweden
Philippines
Singapore
Hungary
United States
Germany
Italy
Brazil
Israel
Spain
Turkey

title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the 6 Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality When Initiated Early After Hospitalization for Acute Decompensated Heart Failure

summary: This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.


title: A Randomized, Double-blind, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug (RO5024048) in Combination With Pegasys® and Ribavirin® (SOC) Versus SOC in Treatment-Naïve Patients With HCV Genotype 1 or 4 Infection

summary: This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4. The first 3 groups will receive 1) RO5024048 500mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks; 2)RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks; 3) RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients in these 3 groups who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks. Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks, and group 5 will receive SOC for 48 weeks. Group 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks. The anticipated time on study treatment is 6-12 months.

ReferenceCitation: Tong X, Le Pogam S, Li L, Haines K, Piso K, Baronas V, Yan JM, So SS, Klumpp K, Nájera I. In vivo emergence of a novel mutant L159F/L320F in the NS5B polymerase confers low-level resistance to the HCV polymerase inhibitors mericitabine and sofosbuvir. J Infect Dis. 2014 Mar 1;209(5):668-75. doi: 10.1093/infdis/jit562. Epub 2013 Oct 23.

family: Tong

full_name: Xiao Tong

given: Xiao

family: Le Pogam

full_name: Sophie Le Pogam

given: Sophie

family: Li

full_name: Lewyn Li

given: Lewyn

family: Haines

full_name: Kristin Haines

given: Kristin

family: Piso

full_name: Katherine Piso

given: Katherine

family: Baronas

full_name: Victoria Baronas

given: Victoria

family: Yan

full_name: Jun-Mei Yan

given: Jun-Mei

family: So

full_name: Sung-Sau So

given: Sung-Sau

family: Klumpp

full_name: Klaus Klumpp

given: Klaus

family: Nájera

full_name: Isabel Nájera

given: Isabel

journal_name: The Journal of Infectious Diseases

title: In Vivo Emergence of a Novel Mutant L159F/L320F in the NS5B Polymerase Confers Low-Level Resistance to the HCV Polymerase Inhibitors Mericitabine and Sofosbuvir

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Austria
United States
Germany
France
Australia
Puerto Rico
Spain
Canada
United Kingdom


location_country:
United States
France
Singapore
Germany
United Kingdom
Korea, Republic of

location_facility: UT Southwestern University Hospital - St. Paul

location_facility: John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC)

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Memorial Sloan - Kettering Cancer Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Washington University School of Medicine

location_facility: University of Wisconsin Hospital and Clinics

location_facility: John Theurer Cancer Center, Hackensack University Medical Center

location_facility: Loyola University Medical Center, Foster G. McGraw Hospital and Satellites

location_facility: Departement d'Hematologie et d'Oncologie-

location_facility: Penn State Milton S Hershey Medical Center

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

location_facility: University of Texas, MD Anderson Cancer Center

title: An Open-label, Single-arm, Phase 2 Study Of Inotuzumab Ozogamicin Plus Rituximab In Subjects With Relapsed/Refractory Cd22-positive Diffuse Large B-cell Lymphoma, Eligible For Autologous Stem Cell Transplantation

summary: The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma.


lead_sponsor: Bayer

location_country:
Peru
Greece
Belgium
Russian Federation
Taiwan
India
Pakistan
France
Japan
Poland
Thailand
Argentina
Indonesia
Canada
Korea, Republic of
South Africa
Chile
Sweden
Hong Kong
Netherlands
Philippines
Bulgaria
Singapore
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
Spain
Turkey

acronym: MISSION

title: A Phase III, Multi-center, Placebo-Controlled Trial of Sorafenib (BAY43-9006) in Patients With Relapsed or Refractory Advanced Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC) After 2 or 3 Previous Treatment Regimens for Advanced Disease

summary: The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition to the non-cancer treatments patients would normally receive) is an effective treatment for lung cancer compared to best supportive care alone. The safety and tolerability of the two treatment groups will also be compared. The goal of the study is to test the ability of sorafenib to improve survival compared to best supportive care alone.


title: Study of GSK2132231A Antigen-Specific Cancer Immunotherapeutic in Association With Chemotherapy in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

summary: The purpose of this clinical trial is to find out how successfully, patients with progressive metastatic cutaneous melanoma, are able to develop an immune response to injections with the immunotherapeutic product GSK1572932A when given in combination with dacarbazine and evaluate the safety of this combination.

ReferenceCitation: Grob JJ, Mortier L, D'Hondt L, Grange F, Baurain JF, Dréno B, Lebbe C, Robert C, Dompmartin A, Neyns B, Gillet M, Louahed J, Jarnjak S, Lehmann FF. Safety and immunogenicity of MAGE-A3 cancer immunotherapeutic with dacarbazine in patients with MAGE-A3-positive metastatic cutaneous melanoma: an open phase I/II study with a first assessment of a predictive gene signature. ESMO Open. 2017 Nov 14;2(5):e000203. doi: 10.1136/esmoopen-2017-000203. eCollection 2017.

family: Grob

full_name: Jean-Jacques Grob

given: Jean-Jacques

family: Mortier

full_name: Laurent Mortier

given: Laurent

family: D’Hondt

full_name: Lionel D’Hondt

given: Lionel

family: Grange

full_name: Florent Grange

given: Florent

family: Baurain

full_name: JeanFrancois Baurain

given: JeanFrancois

family: Dréno

full_name: Brigitte Dréno

given: Brigitte

family: Lebbe

full_name: Céleste Lebbe

given: Céleste

family: Robert

full_name: Caroline Robert

given: Caroline

family: Dompmartin

full_name: Anne Dompmartin

given: Anne

family: Neyns

full_name: Bart Neyns

given: Bart

family: Gillet

full_name: Marc Gillet

given: Marc

family: Louahed

full_name: Jamila Louahed

given: Jamila

family: Jarnjak

full_name: Silvija Jarnjak

given: Silvija

family: Lehmann

full_name: Frédéric F. Lehmann

given: Frédéric F.

currency_apc_doaj: EUR

journal_name: ESMO Open

oa_colors: green gold

evidence: oa journal (via doaj)

lead_sponsor: GlaxoSmithKline

location_country: Belgium France


ReferenceCitation: Gottfried M, Bennouna J, Bondarenko I, Douillard JY, Heigener DF, Krzakowski M, Mellemgaard A, Novello S, Orlov S, Summers Y, von Pawel J, Stöhr J, Kaiser R, Reck M. Efficacy and Safety of Nintedanib Plus Docetaxel in Patients with Advanced Lung Adenocarcinoma: Complementary and Exploratory Analyses of the Phase III LUME-Lung 1 Study. Target Oncol. 2017 Aug;12(4):475-485. doi: 10.1007/s11523-017-0517-2.

family: Gottfried

full_name: Maya Gottfried

given: Maya

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Bondarenko

full_name: Igor Bondarenko

given: Igor

family: Douillard

full_name: Jean-Yves Douillard

given: Jean-Yves

family: Heigener

full_name: David F. Heigener

given: David F.

family: Krzakowski

full_name: Maciej Krzakowski

given: Maciej

family: Mellemgaard

full_name: Anders Mellemgaard

given: Anders

family: Novello

full_name: Silvia Novello

given: Silvia

family: Orlov

full_name: Sergei Orlov

given: Sergei

family: Summers

full_name: Yvonne Summers

given: Yvonne

family: von Pawel

full_name: Joachim von Pawel

given: Joachim

family: Stöhr

full_name: Julia Stöhr

given: Julia

family: Kaiser

full_name: Rolf Kaiser

given: Rolf

family: Reck

full_name: Martin Reck

given: Martin

journal_name: Targeted Oncology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Reck M, Kaiser R, Mellemgaard A, Douillard JY, Orlov S, Krzakowski M, von Pawel J, Gottfried M, Bondarenko I, Liao M, Gann CN, Barrueco J, Gaschler-Markefski B, Novello S; LUME-Lung 1 Study Group. Docetaxel plus nintedanib versus docetaxel plus placebo in patients with previously treated non-small-cell lung cancer (LUME-Lung 1): a phase 3, double-blind, randomised controlled trial. Lancet Oncol. 2014 Feb;15(2):143-55. doi: 10.1016/S1470-2045(13)70586-2. Epub 2014 Jan 9.

full_name: Sergey Orlov

given: Sergey

location_country:
Greece
Romania
Belgium
Russian Federation
Denmark
Ukraine
India
Spain
Croatia
France
Lithuania
Poland
Slovakia
Korea, Republic of
South Africa
Switzerland
Bulgaria
China
Portugal
Germany
United Kingdom
Italy
Austria
Czechia
Israel
Georgia
Belarus

acronym: BIBF 1120 plus docetaxel in 2nd line NSCLC

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: First Affiliated Hospital of Dalian Medical University

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Kryvorizskyi regional communal clinical oncology centre

location_facility: SBIH of Arkhangelsk reg. "Arkhangelsk Clin. Onc. Dispensary"

location_facility: Fundación Instituto Valenciano de Oncologia

location_facility: Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos

location_facility: Onco.Cent. - Instit. of Maria Sklodowskiej-Curie

location_facility: Sainte Anne Training hospital for the armies

location_facility: Azienda Sanitaria Ospedale S. Luigi Gonzaga

location_facility: University Hospital of Heraklion, University Pulmonology Cl

location_facility: GUZ "Regional Clinical Oncology Dispensary"

location_facility: GUZ Sverdlovsky Regional Oncology Dispensary

location_facility: Gemeinschaftspraxis Dr. Brudler / Dr. Heinrich, Augsburg

location_facility: Multiprofile Hospital for Active Treatment

location_facility: FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF

location_facility: Specialized Hospital for Active Treatment in Oncolcogy

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: City Cancer Centre, Cancer Hospital & Research

location_facility: St. Anna Hospital, 2nd Internal Department

location_facility: Clinical Hospital Centar Sestre Milosrdnice

location_facility: GUZ Leningradskaya Regional Clin. Hospital, St. Petersburg

location_facility: Royal Bournemouth and Christchurch Hospital

location_facility: Helios Dr. Horst Schmidt Kliniken Wiesbaden

location_facility: Krankenhaus Martha-Maria Halle-Dölau gGmbH

location_facility: The Third Affiliated Hospital of Harbin Medical University

location_facility: The Chaim Sheba Medical Center Tel Hashomer

location_facility: Institute of Tuberculosis & Pulmonology, III. Dept., Olsztyn

location_facility: SBIH of Stavropol territory "Pyatigorsk Oncol. Dispensary"

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: Allgemeines Krankenhaus Harburg, 21075 Hamburg

location_facility: Emergency Clinical County Hospital "Sf Spiridon", Iasi

location_facility: Univ.Multiprofile Hospital "Dr. Georgy Stranski" EAD, Pleven

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

location_facility: Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland

location_facility: FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF

location_facility: Institut onkologie a rehabilitace Na Plesi s.r.o.

location_facility: Chmelnytskyi Oblasnnyi Oncologichnyi Tsentr

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Athens Hospital of Chest Diseasea "SOTIRIA"

location_facility: Spitalul Clinic Judetean de Urgenta Brasov

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta"

location_facility: Chemotherapy & Immunotherapy Clinic 'Medulla', Tbilisi

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Ospedale S.Maria della Misericordia, AO di Perugia

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: The Second Affiliated Hospital of Dalian Medical University

location_facility: Bhagwan Mahaveer Cancer Hospital & Research Center, Jawahar

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

location_facility: B. P .Poddar Hospital & Medical Research Ltd.

location_facility: Papageorgiou Hospital, 1st Cardiological Cl., Thessaloniki

location_facility: Public Health Inst. Minsk City Clinical Oncology Dispensary

location_facility: RBIH "Kursk regional clinical oncology dispensary"

location_facility: Jawaharlal Nehru Cancer Hospital & Research Centre

location_facility: SPb SBIH "City Clinical Oncological Dispensary"

location_facility: Vitebsk Regional Clinical Oncology Dispensary

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie, Köln

location_facility: Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'

location_facility: Universitätsklinik links der Isar, München, Ziemssenstr. 1

location_facility: Kharkiv Medical Acadamy of Postgraduate education

location_facility: GUZ Irkutsk Regional Oncology Dispensary

location_facility: CHU de Rouen - Hôpital de Bois Guillaume

location_facility: Rajiv Gandhi Cancer Institute and Research Centre

location_facility: Katholisches Klinikum St. Hildegardiskrankenhaus, Mainz

location_facility: GUZ Regional Oncology Dispensary, Magnitogorsk

location_facility: Ternopil regional communal clinical oncology centre

location_facility: District Hospital Pribram, Oncology Centrum

location_facility: Emergency County Hospital "Sf.loan cel Nou"

location_facility: Universitätsklinikum Benjamin Franklin, Berlin

location_facility: Uzhgorod National University, Oncology Centre

location_facility: Vinnytsia Regional Clinical Oncological Dispensary

location_facility: St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"

title: Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral BIBF 1120 Plus Standard Docetaxel Therapy Compared to Placebo Plus Standard Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent Non Small Cell Lung Cancer After Failure of First Line Chemotherapy

summary: The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with standard therapy of docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In addition, blood will be collected for pharmacokinetic analysis.


ReferenceCitation: Middleton G, Gridelli C, De Marinis F, Pujol JL, Reck M, Ramlau R, Parente B, Pieters T, Visseren-Grul CM, San Antonio B, John WJ, Zimmermann AH, Chouaki N, Paz-Ares L. Evaluation of changes in renal function in PARAMOUNT: a phase III study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. Curr Med Res Opin. 2018 May;34(5):865-871. doi: 10.1080/03007995.2018.1439462. Epub 2018 Mar 27.

name: University of Birmingham, Birmingham, United Kingdom;

family: Middleton

full_name: Gary Middleton

given: Gary

family: Gridelli

full_name: Cesare Gridelli

given: Cesare

name: European Institute of Oncology, Milan, Italy;

family: De Marinis

full_name: Filippo De Marinis

given: Filippo

name: Centre Hospitalier Régional Universitaire de Montpellier, Montpellier, France;

family: Pujol

full_name: Jean-Louis Pujol

given: Jean-Louis

name: Department of Thoracic Oncology, LungenClinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany;

name: Poznan University of Medical Sciences, Poznan, Poland;

family: Ramlau

full_name: Rodryg Ramlau

given: Rodryg

family: Parente

full_name: Barbara Parente

given: Barbara

name: Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium;

family: Pieters

full_name: Thierry Pieters

given: Thierry

name: Eli Lilly and Company, Houten, Netherlands;

family: Visseren-Grul

full_name: Carla M. Visseren-Grul

given: Carla M.

family: San Antonio

full_name: Bélen San Antonio

given: Bélen

name: Eli Lilly and Company, Indianapolis, IN, USA;

family: John

full_name: William J. John

given: William J.

family: Zimmermann

full_name: Annamaria Hayden Zimmermann

given: Annamaria Hayden

family: Chouaki

full_name: Nadia Chouaki

given: Nadia

name: IBIS (University Hospital Virgen del Rocío, Seville University and CSIC), Seville & Doce de Octubre University Hospital, Madrid, Spain

family: Paz-Ares

full_name: Luis Paz-Ares

given: Luis

journal_name: Current Medical Research and Opinion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Pujol JL, Paz-Ares L, de Marinis F, Dediu M, Thomas M, Bidoli P, Corral J, San Antonio B, Chouaki N, John W, Zimmermann A, Visseren-Grul C, Gridelli C. Long-term and low-grade safety results of a phase III study (PARAMOUNT): maintenance pemetrexed plus best supportive care versus placebo plus best supportive care immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2014 Nov;15(6):418-25. doi: 10.1016/j.cllc.2014.06.007. Epub 2014 Jun 21.

family: de Marinis

full_name: Filippo de Marinis

family: Dediu

full_name: Mircea Dediu

given: Mircea

family: Thomas

full_name: Michael Thomas

given: Michael

family: Bidoli

full_name: Paolo Bidoli

given: Paolo

family: Corral

full_name: Jesus Corral

given: Jesus

full_name: Belen San Antonio

given: Belen

title: Long-Term and Low-Grade Safety Results of a Phase III Study (PARAMOUNT): Maintenance Pemetrexed Plus Best Supportive Care Versus Placebo Plus Best Supportive Care Immediately After Induction Treatment With Pemetrexed Plus Cisplatin for Advanced Nonsquamous Non–Small-Cell Lung Cancer

ReferenceCitation: Reck M, Paz-Ares LG, de Marinis F, Molinier O, Sahoo TP, Laack E, John W, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Descriptive subgroup analyses of final overall survival for the phase III study of maintenance pemetrexed versus placebo following induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2014 Feb;9(2):205-13. doi: 10.1097/JTO.0000000000000076.

title: PARAMOUNT: Descriptive Subgroup Analyses of Final Overall Survival for the Phase III Study of Maintenance Pemetrexed versus Placebo Following Induction Treatment with Pemetrexed Plus Cisplatin for Advanced Nonsquamous Non–Small-Cell Lung Cancer

ReferenceCitation: Paz-Ares LG, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Aug 10;31(23):2895-902. doi: 10.1200/JCO.2012.47.1102. Epub 2013 Jul 8.

name: Luis Paz-Ares and Jesús Corral, University Hospital Virgen del Rocío, Seville, Spain; Filippo de Marinis, San Camillo-Forlanini Hospital, Rome; Paolo Bidoli, S. Gerardo Hospital, Monza; Cesare Gridelli, San Giuseppe Moscati Hospital, Avellino, Italy; Mircea Dediu, Institute of Oncology Bucharest, Bucharest, Romania; Michael Thomas, University of Heidelberg, Heidelberg; Eckart Laack, University Medical Center Hamburg-Eppendorf, Hamburg; Martin Reck, Hospital Grosshansdorf, Grosshansdorf, Germany; Jean...

publisher: American Society of Clinical Oncology (ASCO)

title: PARAMOUNT: Final Overall Survival Results of the Phase III Study of Maintenance Pemetrexed Versus Placebo Immediately After Induction Treatment With Pemetrexed Plus Cisplatin for Advanced Nonsquamous Non–Small-Cell Lung Cancer

ReferenceCitation: Zeng X, Peng L, Li J, Chen G, Tan C, Wang S, Wan X, Ouyang L, Zhao Z. Cost-effectiveness of continuation maintenance pemetrexed after cisplatin and pemetrexed chemotherapy for advanced nonsquamous non-small-cell lung cancer: estimates from the perspective of the Chinese health care system. Clin Ther. 2013 Jan;35(1):54-65. doi: 10.1016/j.clinthera.2012.12.013.

title: Cost-Effectiveness of Continuation Maintenance Pemetrexed After Cisplatin and Pemetrexed Chemotherapy for Advanced Nonsquamous Non–Small-Cell Lung Cancer: Estimates From the Perspective of the Chinese Health Care System

ReferenceCitation: Gridelli C, de Marinis F, Pujol JL, Reck M, Ramlau R, Parente B, Pieters T, Middleton G, Corral J, Winfree K, Melemed S, Zimmermann A, John W, Beyrer J, Chouaki N, Visseren-Grul C, Paz-Ares LG. Safety, resource use, and quality of life in paramount: a phase III study of maintenance pemetrexed versus placebo after induction pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2012 Nov;7(11):1713-21. doi: 10.1097/JTO.0b013e318267cf84.

title: Safety, Resource Use, and Quality of Life in Paramount: A Phase III Study of Maintenance Pemetrexed Versus Placebo after Induction Pemetrexed Plus Cisplatin for Advanced Nonsquamous Non–Small-Cell Lung Cancer

ReferenceCitation: Paz-Ares L, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2012 Mar;13(3):247-55. doi: 10.1016/S1470-2045(12)70063-3. Epub 2012 Feb 16.

ReferenceCitation: Paz-Ares LG, Altug S, Vaury AT, Jaime JC, Russo F, Visseren-Grul C. Treatment rationale and study design for a phase III, double-blind, placebo-controlled study of maintenance pemetrexed plus best supportive care versus best supportive care immediately following induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small cell lung cancer. BMC Cancer. 2010 Mar 8;10:85. doi: 10.1186/1471-2407-10-85.

location_country:
Italy
India
Netherlands
Spain
Finland
France
Poland
Greece
Romania
Belgium
Australia
Portugal
Turkey
Germany
United Kingdom

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

title: A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment With Pemetrexed + Cisplatin for Advanced Non-squamous Non-Small Cell Lung Cancer.

summary: This study will compare progression-free survival in patients with advanced non-squamous non-small cell lung cancer. Patients who do not progress following 4 cycles of induction treatment with pemetrexed and cisplatin will be randomized 2:1 to receive either maintenance pemetrexed or placebo.


status: Recruiting

lead_sponsor: Genentech, Inc.

enrollment_type: Anticipated

location_country:
Peru
Guatemala
North Macedonia
Australia
Belgium
Russian Federation
Denmark
Taiwan
Croatia
France
Japan
Panama
Poland
Norway
Thailand
Canada
Slovenia
Korea, Republic of
Chile
Sweden
Hong Kong
Switzerland
Philippines
Bulgaria
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain

acronym: Extension study

location_facility: Christina Care Institutional Review Board

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia

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

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Hiroshima University Hospital; Breast Surgery

location_facility: Northwest Cancer Specialists - Portland (N Broadway)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Univ of Calif, San Francisco; Breast Cancer Center

location_facility: Private Health Organization Acibadem Sistina Hospital

location_facility: Hematology-Oncology; Associates of the Quad Cities

location_facility: Ottawa Regional Cancer Centre; Civic Hospital Division

location_facility: Hospital Severo Ochoa; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche

location_facility: Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

location_facility: The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: RCCS - Centro di Riferimento; Oncologia Medica B

location_facility: Saitama Medical University International Medical Center; Breast Oncology

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Dana Farber Cancer Institute; Breast Oncology

location_facility: BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)

location_facility: Hämatologisch-Onkologische Schwerpunktpraxis; Dres. Schlag & Schöttker

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Anne Arundel Medical Center; Anne Arundel Health System

location_facility: Severance Hospital, Yonsei University Health System

location_facility: FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: St. John's Mercy Medical Ctr; David C. Pratt Cancer Center

location_facility: National Cheng Kung Uni Hospital; Surgery

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Hospital de Jerez de la Frontera; Servicio de Oncologia

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: Humanitas Istituto Clinico Catanese S.p.A

location_facility: Florida Cancer Specialists; Department of Oncology

location_facility: Ospedale Misericordia E Dolce; Oncologia Medica

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Cebu Cancer Institute; Perpetual Succour Hospital

location_facility: Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika

location_facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

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

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Clinica de Oncologia de Porto Alegre - CliniOnco

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Western General Hospital; Clinical Oncology

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Klinik Favoriten; 1 Medizinische Abteilung

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Kyungpook National University Medical Center; Oncology

location_facility: Świętokrzyskie Centrum Onkologii; Dział Chemioterapii

location_facility: CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY

location_facility: Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Veterans Memorial Medical Ctr; Cancer Research Centre

location_facility: Can Care Assoc Med Group Inc; Beach Cities Offices

location_facility: Ospedale San Carlo; Day Hospital Oncologia Medica

location_facility: Harbin Medical University Cancer Hospital

location_facility: Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika

location_facility: Centro de Investigacion; Clinica Del Pacifico

location_facility: Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

location_facility: Midwestern Regional Medical Center; Office of Research

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Florida Cancer Specialists - Tampa (Dr. MLK Blvd)

location_facility: Centre Hospitalier de l'Université de Montréal (CHUM)

location_facility: Complex Oncology Center - Plovdiv First Internal Chemotherapy Department

location_facility: Oncology Assoc of Cedar Rapids; Iowa Cancer Care

location_facility: HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe

location_facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Carolina Oncology Specialists, PA - Hickory

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

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Uniklinik Köln, Klinik und Poliklinik und Geburtshilfe; Brustzentrum Köln

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Memorial Cancer Institute at Memorial West

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Uni of Washington Medical Center; Dept of Oncology

location_facility: Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

location_facility: Campus Universitario S.Venuta; Centro Oncologico T.Campanella

study_completion_date_type: Anticipated

title: An Open-Label, Multicenter Extension Study of Trastuzumab Emtansine Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd-Sponsored Trastuzumab Emtansine Study

summary: This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.

status_simplified: Ongoing


title: Case Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION

summary: The objective of this non-interventional study is to examine whether use of Phosphodiesterase Inhibitors (PDE5s), including use of sildenafil, vardenafil, or tadalafil, triggers the onset of acute NAION.

study_type: Observational

time_perspective: Retrospective

ReferenceCitation: Campbell UB, Walker AM, Gaffney M, Petronis KR, Creanga D, Quinn S, Klein BE, Laties AM, Lewis M, Sharlip ID, Kolitsopoulos F, Klee BJ, Mo J, Reynolds RF. Acute nonarteritic anterior ischemic optic neuropathy and exposure to phosphodiesterase type 5 inhibitors. J Sex Med. 2015 Jan;12(1):139-51. doi: 10.1111/jsm.12726. Epub 2014 Oct 31.

family: Campbell

full_name: Ulka B. Campbell

given: Ulka B.

family: Walker

full_name: Alexander M. Walker

given: Alexander M.

family: Gaffney

full_name: Michael Gaffney

family: Petronis

full_name: Kenneth R. Petronis

given: Kenneth R.

family: Creanga

full_name: Dana Creanga

given: Dana

family: Quinn

full_name: Sheila Quinn

given: Sheila

family: Klein

full_name: Barbara E.K. Klein

given: Barbara E.K.

family: Laties

full_name: Alan M. Laties

given: Alan M.

family: Lewis

full_name: Michael Lewis

family: Sharlip

full_name: Ira D. Sharlip

given: Ira D.

family: Kolitsopoulos

full_name: Francesca Kolitsopoulos

given: Francesca

family: Klee

full_name: Brian J. Klee

given: Brian J.

family: Mo

full_name: Jingping Mo

given: Jingping

family: Reynolds

full_name: Robert F. Reynolds

given: Robert F.

journal_name: The Journal of Sexual Medicine

title: Acute Nonarteritic Anterior Ischemic Optic Neuropathy and Exposure to Phosphodiesterase Type 5 Inhibitors

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Italy
United States
France
Spain
Germany
United Kingdom


title: A Randomized Double Blind Phase III Trial of Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy

acronym: PALETTE

summary: A randomized double blind phase III trial of Pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or following prior therapy

ReferenceType: background

ReferenceCitation: van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, Schöffski P, Aglietta M, Staddon AP, Beppu Y, Le Cesne A, Gelderblom H, Judson IR, Araki N, Ouali M, Marreaud S, Hodge R, Dewji MR, Coens C, Demetri GD, Fletcher CD, Dei Tos AP, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group; PALETTE study group. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012 May 19;379(9829):1879-86. doi: 10.1016/S0140-6736(12)60651-5. Epub 2012 May 16.

ReferenceCitation: Cesne AL, Bauer S, Demetri GD, Han G, Dezzani L, Ahmad Q, Blay JY, Judson I, Schöffski P, Aglietta M, Hohenberger P, Gelderblom H. Safety and efficacy of Pazopanib in advanced soft tissue sarcoma: PALETTE (EORTC 62072) subgroup analyses. BMC Cancer. 2019 Aug 13;19(1):794. doi: 10.1186/s12885-019-5988-3.

family: Cesne

full_name: Axel Le Cesne

given: Axel Le

family: Bauer

full_name: Sebastian Bauer

given: Sebastian

family: Demetri

full_name: George D. Demetri

given: George D.

family: Han

full_name: Guangyang Han

given: Guangyang

family: Dezzani

full_name: Luca Dezzani

given: Luca

family: Ahmad

full_name: Qasim Ahmad

given: Qasim

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Judson

full_name: Ian Judson

given: Ian

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

family: Aglietta

full_name: Massimo Aglietta

given: Massimo

family: Hohenberger

full_name: Peter Hohenberger

given: Peter

family: Gelderblom

full_name: Hans Gelderblom

given: Hans

currency_apc_doaj: GBP

journal_name: BMC Cancer

repository_institution: University of Turin - Institutional Research Information System University of Turin

repositories:
LIRIAS (KU Leuven)
PubMed Central
iris.unito.it

ReferenceCitation: Kawai A, Araki N, Hiraga H, Sugiura H, Matsumine A, Ozaki T, Ueda T, Ishii T, Esaki T, Machida M, Fukasawa N. A randomized, double-blind, placebo-controlled, Phase III study of pazopanib in patients with soft tissue sarcoma: results from the Japanese subgroup. Jpn J Clin Oncol. 2016 Mar;46(3):248-53. doi: 10.1093/jjco/hyv184. Epub 2016 Feb 10.

family: Kawai

ReferenceCitation: Kasper B, Sleijfer S, Litière S, Marreaud S, Verweij J, Hodge RA, Bauer S, Kerst JM, van der Graaf WTA. Long-term responders and survivors on pazopanib for advanced soft tissue sarcomas: subanalysis of two European Organisation for Research and Treatment of Cancer (EORTC) clinical trials 62043 and 62072. Ann Oncol. 2014 Mar;25(3):719-724. doi: 10.1093/annonc/mdt586. Epub 2014 Feb 6.

location_country:
Italy
Sweden
Netherlands
Germany
France
Japan
Belgium
Australia
Spain
Denmark
United States
United Kingdom
Korea, Republic of


ReferenceCitation: Koch MW, Mostert J, Repovic P, Bowen JD, Strijbis E, Uitdehaag B, Cutter G. Smoking, obesity, and disability worsening in PPMS: an analysis of the INFORMS original trial dataset. J Neurol. 2021 Aug 15. doi: 10.1007/s00415-021-10750-z. [Epub ahead of print]

family: Koch

full_name: Marcus W. Koch

given: Marcus W.

family: Mostert

full_name: Jop Mostert

given: Jop

family: Repovic

full_name: Pavle Repovic

given: Pavle

family: Bowen

full_name: James D. Bowen

given: James D.

family: Strijbis

full_name: Eva Strijbis

given: Eva

family: Uitdehaag

full_name: Bernard Uitdehaag

given: Bernard

family: Cutter

full_name: Gary Cutter

given: Gary

journal_name: Journal of Neurology

ReferenceCitation: Koch MW, Mostert J, Zhang Y, Wolinsky JS, Lublin FD, Strijbis E, Cutter G. Association of Age With Contrast-Enhancing Lesions Across the Multiple Sclerosis Disease Spectrum. Neurology. 2021 Sep 28;97(13):e1334-e1342. doi: 10.1212/WNL.0000000000012603. Epub 2021 Aug 10.

family: Zhang

full_name: Yinan Zhang

given: Yinan

family: Wolinsky

full_name: Jerry S. Wolinsky

given: Jerry S.

family: Lublin

full_name: Fred D. Lublin

given: Fred D.

journal_name: Neurology

ReferenceCitation: Miller DH, Lublin FD, Sormani MP, Kappos L, Yaldizli Ö, Freedman MS, Cree BAC, Weiner HL, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BMJ, MacManus DG, Yousry TA, Gandini Wheeler-Kingshott CAM, Li B, Putzki N, Merschhemke M, Häring DA, Wolinsky JS. Brain atrophy and disability worsening in primary progressive multiple sclerosis: insights from the INFORMS study. Ann Clin Transl Neurol. 2018 Jan 30;5(3):346-356. doi: 10.1002/acn3.534. eCollection 2018 Mar.

name: Queen Square MS Centre; UCL Institute of Neurology; London UK

family: Miller

full_name: David H. Miller

given: David H.

name: The Corinne Goldsmith Dickinson Center for Multiple Sclerosis; Icahn School of Medicine at Mount Sinai; New York New York

name: Biostatistics Unit; Department of Health Sciences (DISSAL); University of Genoa; Via Pastore 1 Genoa 16132 Italy

family: Sormani

full_name: Maria Pia Sormani

given: Maria Pia

name: Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering; University Hospital; University of Basel; Basel Switzerland

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

name: Department of Neurology; University Hospital Basel; Basel Switzerland

family: Yaldizli

full_name: Özgür Yaldizli

given: Özgür

name: The Ottawa Hospital Research Institute; University of Ottawa; Ottawa Ontario

family: Freedman

full_name: Mark S. Freedman

given: Mark S.

name: Multiple Sclerosis Center; University of California; San Francisco California

name: Brigham and Women's Hospital; Harvard Medical School; Boston Massachusetts

name: Center of Clinical Investigation; Salpêtrière Hospital APHP; University Paris 6; Paris France

name: Department of Neurology; Medical Faculty; Heinrich-Heine University; Düsseldorf Germany

name: Hospital Universitari Vall d'Hebron; Barcelona Spain

name: VU University Medical Center; Amsterdam The Netherlands

name: Novartis Pharmaceuticals Corporation; East Hanover New Jersey

name: McGovern Medical School; UTHealth; Houston Texas

journal_name: Annals of Clinical and Translational Neurology

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

repository_institution: University College London - UCL Discovery

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

ReferenceCitation: Lublin F, Miller DH, Freedman MS, Cree BAC, Wolinsky JS, Weiner H, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BMJ, Merschhemke M, Li B, Putzki N, Liu FC, Häring DA, Kappos L; INFORMS study investigators. Oral fingolimod in primary progressive multiple sclerosis (INFORMS): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2016 Mar 12;387(10023):1075-1084. doi: 10.1016/S0140-6736(15)01314-8. Epub 2016 Jan 28. Erratum in: Lancet. 2017 Jan 21;389(10066):254.

ReferenceCitation: Hartung HP, Aktas O. Bleak prospects for primary progressive multiple sclerosis therapy: downs and downs, but a glimmer of hope. Ann Neurol. 2009 Oct;66(4):429-32. doi: 10.1002/ana.21880.

title: Bleak prospects for primary progressive multiple sclerosis therapy: Downs and downs, but a glimmer of hope

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Italy
United States
Sweden
Switzerland
Netherlands
Germany
Finland
France
Czechia
Poland
Hungary
Belgium
Australia
Spain
Turkey
Denmark
Canada
United Kingdom

title: A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5mg Fingolimod Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis and An Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis

summary: The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS. This was an open-label, single-arm extension study to a double-blind, randomized multicenter, placebo-controlled, parallel-group core study. The core study completed and eligible patients enrolled into the extension study at the next scheduled or unscheduled core study visit. All patients, regardless of their treatment in the core study, received fingolimod 0.5 mg in the extension study. The extension study was terminated early after the results of the core study became available showing that the study did not meet its primary endpoint which was defined as confirmed disability progression in this population