title: Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)

acronym: EchoCRT

summary: The EchoCRT trial evaluates the effects of Cardiac Resynchronization Therapy (CRT) on mortality and morbidity of subjects with heart failure due to left ventricular systolic dysfunction, already receiving optimized HF medication, with a narrow QRS width (< 130 ms) and echocardiographic evidence of ventricular dyssynchrony.

ReferenceCitation: Varma N, Sogaard P, Bax JJ, Abraham WT, Borer JS, Dickstein K, Singh JP, Gras D, Holzmeister J, Brugada J, Ruschitzka F. Interaction of Left Ventricular Size and Sex on Outcome of Cardiac Resynchronization Therapy Among Patients With a Narrow QRS Duration in the EchoCRT Trial. J Am Heart Assoc. 2018 May 27;7(11). pii: e009592. doi: 10.1161/JAHA.118.009592. Erratum in: J Am Heart Assoc. 2018 Jun 17;7(12):.

name: Cleveland Clinic, Heart and Vascular Institute, Cleveland, OH

family: Varma

full_name: Niraj Varma

given: Niraj

family: Sogaard

full_name: Peter Sogaard

given: Peter

name: Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands

family: Bax

full_name: Jeroen J. Bax

given: Jeroen J.

name: Division of Cardiovascular Medicine, Ohio State University Medical Center, Davis Heart and Lung Research Institute, Columbus, OH

family: Abraham

full_name: William T. Abraham

given: William T.

name: Division of Cardiovascular Medicine and Howard Gilman and Ron and Jean Schiavone Institutes, State University of New York Downstate College of Medicine, Brooklyn, NY

family: Borer

full_name: Jeffrey S. Borer

given: Jeffrey S.

name: University of Bergen Stavanger University Hospital, Stavanger, Norway

family: Dickstein

full_name: Kenneth Dickstein

given: Kenneth

name: Cardiac Arrhythmia Service, Massachusetts General Hospital, Harvard Medical School, Corrigan Minehan Heart Center, Boston, MA

family: Singh

full_name: Jagmeet P. Singh

given: Jagmeet P.

name: Nouvelles Cliniques Nantaises, Nantes, France

family: Gras

full_name: Daniel Gras

given: Daniel

name: Clinic for Cardiology, University Hospital Zurich, Zurich, Switzerland

family: Holzmeister

full_name: Johannes Holzmeister

given: Johannes

name: Cardiology Department, Thorax Institute, Hospital Clinic, University of Barcelona, Spain

family: Brugada

full_name: Josep Brugada

given: Josep

family: Ruschitzka

full_name: Frank Ruschitzka

given: Frank

currency_apc_doaj: USD

journal_name: Journal of the American Heart Association

oa_colors: green gold

evidence: oa journal (via doaj)

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

repository_institution: Aalborg Universitet - VBN Forskningsportal

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

version: submittedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Tayal B, Gorcsan J 3rd, Bax JJ, Risum N, Olsen NT, Singh JP, Abraham WT, Borer JS, Dickstein K, Gras D, Krum H, Brugada J, Robertson M, Ford I, Holzmeister J, Ruschitzka F, Sogaard P. Cardiac Resynchronization Therapy in Patients With Heart Failure and Narrow QRS Complexes. J Am Coll Cardiol. 2018 Mar 27;71(12):1325-1333. doi: 10.1016/j.jacc.2018.01.042.

journal_name: Journal of the American College of Cardiology

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Steffel J, Varma N, Robertson M, Singh JP, Bax JJ, Borer JS, Dickstein K, Ford I, Gorcsan J 3rd, Gras D, Krum H, Sogaard P, Holzmeister J, Brugada J, Abraham WT, Ruschitzka F. Effect of Gender on Outcomes After Cardiac Resynchronization Therapy in Patients With a Narrow QRS Complex: A Subgroup Analysis of the EchoCRT Trial. Circ Arrhythm Electrophysiol. 2016 Jun;9(6). pii: e003924. doi: 10.1161/CIRCEP.115.003924.

name: For the author affiliations, please see the Appendix.

journal_name: Circulation: Arrhythmia and Electrophysiology

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Ruschitzka F, Abraham WT, Singh JP, Bax JJ, Borer JS, Brugada J, Dickstein K, Ford I, Gorcsan J 3rd, Gras D, Krum H, Sogaard P, Holzmeister J; EchoCRT Study Group. Cardiac-resynchronization therapy in heart failure with a narrow QRS complex. N Engl J Med. 2013 Oct 10;369(15):1395-405. doi: 10.1056/NEJMoa1306687. Epub 2013 Sep 2.

repository_institution: St George's University of London - St George's Online Research Archive

title: Cardiac-Resynchronization Therapy in Heart Failure with a Narrow QRS Complex

location_country:
Italy
Austria
United States
Switzerland
Netherlands
Spain
Germany
France
Czechia
Poland
Israel
Australia
Belgium
Portugal
Denmark
Canada
United Kingdom

location_facility: IKEM - Institute for Clinical and Experimental Medicine

location_facility: Michigan Heart, P.C./ St. Joseph Mercy Hospital

location_facility: Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau

location_facility: Jefferson Heart Institute, Thomas Jefferson University Hospital

location_facility: University Hospitals of Coventry and Warwickshire

location_facility: Promedica Northwest Ohio Cardiology Consultants

location_facility: Thoracic & Cardiovascular Healthcare Foundation

location_facility: The Ohio State University Richard M. Ross Heart Hospital


ReferenceType: background

ReferenceCitation: Chawla S, Henshaw R, Seeger L, Choy E, Blay JY, Ferrari S, Kroep J, Grimer R, Reichardt P, Rutkowski P, Schuetze S, Skubitz K, Staddon A, Thomas D, Qian Y, Jacobs I. Safety and efficacy of denosumab for adults and skeletally mature adolescents with giant cell tumour of bone: interim analysis of an open-label, parallel-group, phase 2 study. Lancet Oncol. 2013 Aug;14(9):901-8. doi: 10.1016/S1470-2045(13)70277-8. Epub 2013 Jul 16.

ReferenceCitation: Martin-Broto J, Cleeland CS, Glare PA, Engellau J, Skubitz KM, Blum RH, Ganjoo KN, Staddon A, Dominkus M, Feng A, Qian Y, Braun A, Jacobs I, Chung K, Atchison C. Effects of denosumab on pain and analgesic use in giant cell tumor of bone: interim results from a phase II study. Acta Oncol. 2014 Sep;53(9):1173-9. doi: 10.3109/0284186X.2014.910313. Epub 2014 May 19.

ReferenceCitation: Rutkowski P, Ferrari S, Grimer RJ, Stalley PD, Dijkstra SP, Pienkowski A, Vaz G, Wunder JS, Seeger LL, Feng A, Roberts ZJ, Bach BA. Surgical downstaging in an open-label phase II trial of denosumab in patients with giant cell tumor of bone. Ann Surg Oncol. 2015 Sep;22(9):2860-8. doi: 10.1245/s10434-015-4634-9. Epub 2015 Jun 2.

ReferenceCitation: Engellau J, Seeger L, Grimer R, Henshaw R, Gelderblom H, Choy E, Chawla S, Reichardt P, O'Neal M, Feng A, Jacobs I, Roberts ZJ, Braun A, Bach BA. Assessment of denosumab treatment effects and imaging response in patients with giant cell tumor of bone. World J Surg Oncol. 2018 Sep 19;16(1):191. doi: 10.1186/s12957-018-1478-3.

ReferenceType: derived

ReferenceCitation: Palmerini E, Seeger LL, Gambarotti M, Righi A, Reichardt P, Bukata S, Blay JY, Dai T, Jandial D, Picci P. Malignancy in giant cell tumor of bone: analysis of an open-label phase 2 study of denosumab. BMC Cancer. 2021 Jan 22;21(1):89. doi: 10.1186/s12885-020-07739-8.

family: Palmerini

full_name: Emanuela Palmerini

given: Emanuela

sequence: first

family: Seeger

full_name: Leanne L. Seeger

given: Leanne L.

sequence: additional

family: Gambarotti

full_name: Marco Gambarotti

given: Marco

family: Righi

full_name: Alberto Righi

given: Alberto

family: Reichardt

full_name: Peter Reichardt

family: Bukata

full_name: Susan Bukata

given: Susan

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Dai

full_name: Tian Dai

given: Tian

family: Jandial

full_name: Danielle Jandial

given: Danielle

family: Picci

full_name: Piero Picci

given: Piero

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMC Cancer

oa_host_type: publisher;repository

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

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license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Bukata SV, Blay JY, Rutkowski P, Skubitz K, Henshaw R, Seeger L, Dai T, Jandial D, Chawla S. Denosumab Treatment for Giant Cell Tumor of the Spine Including the Sacrum. Spine (Phila Pa 1976). 2021 Mar 1;46(5):277-284. doi: 10.1097/BRS.0000000000003728.

full_name: Susan V. Bukata

given: Susan V.

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

family: Skubitz

full_name: Keith Skubitz

given: Keith

family: Henshaw

full_name: Robert Henshaw

given: Robert

full_name: Leanne Seeger

given: Leanne

ReferenceCitation: Chawla S, Blay JY, Rutkowski P, Le Cesne A, Reichardt P, Gelderblom H, Grimer RJ, Choy E, Skubitz K, Seeger L, Schuetze SM, Henshaw R, Dai T, Jandial D, Palmerini E. Denosumab in patients with giant-cell tumour of bone: a multicentre, open-label, phase 2 study. Lancet Oncol. 2019 Dec;20(12):1719-1729. doi: 10.1016/S1470-2045(19)30663-1. Epub 2019 Nov 6.

ReferenceCitation: Uday S, Gaston CL, Rogers L, Parry M, Joffe J, Pearson J, Sutton D, Grimer R, Högler W. Osteonecrosis of the Jaw and Rebound Hypercalcemia in Young People Treated With Denosumab for Giant Cell Tumor of Bone. J Clin Endocrinol Metab. 2018 Feb 1;103(2):596-603. doi: 10.1210/jc.2017-02025.

name: Department of Endocrinology and Diabetes, Birmingham Women’s and Children’s Hospital NHS Foundation Trust, Birmingham, West Midlands B4 6NH, United Kingdom

name: Institute of Metabolism and Systems Research, University of Birmingham, Birmingham B15 2TT, United Kingdom

name: Department of Orthopaedics, Philippine General Hospital, 1000 Manila, Philippines

name: Department of Medical Oncology, Calderdale and Huddersfield NHS Foundation Trust, Huddersfield HX3 0PW, United Kingdom

name: Department of Orthopaedic Oncology, The Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham B31 2AP, United Kingdom

name: Department of Maxillofacial Surgery, Calderdale and Huddersfield NHS Foundation Trust, Huddersfield HD3 3EA, United Kingdom

journal_name: The Journal of Clinical Endocrinology & Metabolism

repository_institution: University of Birmingham - University of Birmingham Research Portal

ReferenceCitation: van der Heijden L, van de Sande MA, Hogendoorn PC, Gelderblom H, Dijkstra PD. Neoadjuvant denosumab for extensive giant cell tumor in os ischium: a case report. Acta Orthop. 2015 Jun;86(3):393-5. doi: 10.3109/17453674.2014.1002345. Epub 2015 Feb 14.

name: 1Departments of Orthopedic Surgery,Leiden University Medical Center, Leiden, the Netherlands

name: 2Departments of Pathology,Leiden University Medical Center, Leiden, the Netherlands

name: 3Departments of Clinical Oncology,Leiden University Medical Center, Leiden, the Netherlands

title: Neoadjuvant denosumab for extensive giant cell tumor in os ischium —a case report

location_country:
Italy
Austria
United States
Sweden
Netherlands
Germany
France
Poland
Australia
Spain
Canada
United Kingdom

title: An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects With Giant Cell Tumor of Bone

summary: To determine how safe denosumab is in treating subjects with giant cell tumor of bone (GCTB)


design_allocation: Randomized

intervention_type: Drug

status: Terminated

study_type: Interventional

lead_sponsor: Boehringer Ingelheim

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Italy
Austria
South Africa
Sweden
Netherlands
Germany
Finland
France
Korea, Republic of
Lithuania
Slovakia
Hungary
Estonia
Denmark
United States
Latvia
Canada

acronym: 48-week comparison of Tiotropium/Salmeterol Inhalation Powder with the individual components

location_facility: 1184.15.01064 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01059 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.3350A Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01065 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01057 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.49052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.82053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.42154 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01072 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.3351A Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.42153 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37152 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01070 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.35851 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02055 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.43053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.45054 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.49053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01069 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37154 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37153 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02057 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02060 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.49057 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.45052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.49058 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.82051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.46051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.31051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37251 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.31052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01054 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01062 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.3352A Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01071 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.31054 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02059 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02058 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37252 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.36053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.43052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.49056 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.39051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.46053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.45053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.36052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01063 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02056 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.36055 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.35852 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.45051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.82052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01058 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.36054 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01055 Boehringer Ingelheim Investigational Site

type: EudraCT Number

source: euctr

title: 1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)

summary: The primary objectives of this study are to assess bronchodilator efficacy as determined by FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as determined bt the SGRQ and the effect on COPD exacerbations

lead_sponsor_type: industriel

status_simplified: Unknown


ReferenceCitation: Krause A, Zisowsky J, Dingemanse J. Modeling of pharmacokinetics, efficacy, and hemodynamic effects of macitentan in patients with pulmonary arterial hypertension. Pulm Pharmacol Ther. 2018 Apr;49:140-146. doi: 10.1016/j.pupt.2018.02.005. Epub 2018 Feb 28.

family: Krause

full_name: Andreas Krause

given: Andreas

family: Zisowsky

full_name: Jochen Zisowsky

given: Jochen

family: Dingemanse

full_name: Jasper Dingemanse

given: Jasper

journal_name: Pulmonary Pharmacology & Therapeutics

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

status: Completed

study_start_date_type: Actual

lead_sponsor: Actelion

location_country:
Peru
Finland
Malaysia
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
India
Croatia
France
Poland
Slovakia
Thailand
Argentina
Canada
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Bulgaria
Singapore
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Serbia
Mexico
Israel
Belarus

acronym: SERAPHIN OL

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: University of Pecs, Medical School/Heart Institute and 1st Department of Internal Medicine

location_facility: Srinagarind Hospital/Division of Rheumatology, Department of Medicine, Faculty of Medicine, Khon Kaen University

location_facility: University of Colorado CARDIAC AND VASCULAR CENTER

location_facility: University of Iowa, Pulmonary Hypertension Program

location_facility: Ramathibodi Hospital, Mahidol University, Cardiology Unit, Department of Medicine,

location_facility: Beijing Anzhen Hospital of the Capital University of Medical Sciences, Cardiology Department

location_facility: Federal State Institution "State Scientific Research Centre of Preventive Medicine" of Rosmedtechnology

location_facility: Unidad de Investigación Clinica en Medicina

location_facility: Hosp Bicetre - Dept Pulmo & Resp Intensive Care

location_facility: Louisiana State University Health Sciences Center

location_facility: Municipal Health Care Institution Kemerovo Cardiology Dispensary

location_facility: Zhongshan Hospital Fudan University, Cardiology Department

location_facility: National University Hospital/ The Heart Institute

location_facility: Rabin Medical Center - Belinson campus - Pulmonary Institute

location_facility: University of Szeged Albert Szent-Gyorgyi Medical & Pharmaceutical Center

location_facility: Netcare Milpark Hospital,Center for Chest Disease

location_facility: Federal State Institution "Russian Cardiology Scientific and Production Complex of Rosmedtechnology"

location_facility: Intermountain Med Ctr- Pulm Dept Heart and Lung Ctr

location_facility: Zemun Clinical Hospital (Klinicko-bolnicki centar Zemun) / Department of Cardiology

location_facility: University Children's Hospital (UNIVERZITETSKA DECJA KLINKIKA)

location_facility: University Hospital of Lund, Dept. of Cardiology

location_facility: Federal State Institution "Scientific Research Institute of Pulmonology of Roszdrav"

location_facility: Sentara Hospitals T/A Sentara Cardiovascular Research Intitute

location_facility: Dnipropetrovsk State Medical Academy / Regional Diagnostic Center, Department of electrophysiologic researches and anaesthesiologic aid

location_facility: Peking Union Medical College Hospital, Rheumatology Department

location_facility: Pulmonary/Critical Care Division/Tufts New England Medical Center

location_facility: The pulmonary institute Sheba Medical centre

location_facility: University of Texas Houston Health Center

location_facility: Ohio State University, Div. of Pul. & Critical Care

location_facility: Danylo Galytskyi Lviv State Medical University

location_facility: Universitätsklinikum Essen, Klinik für Kardiologie , Zentrum für Innere Medizin

location_facility: Tomsk Regional Clinical Hospital / Pulmonology Unit

location_facility: Medical University of Vienna/ Department of Internal Medicine II, Division of Cardiology

location_facility: Sverdlovsk Regional Clinical Hospital # 1/ Cardiology Department (2nd Therapy Department)

location_facility: Instituto Nacional de Cardiología (INC) Ignacio Chávez

location_facility: Baylor College of Medicine and the Methodist Hospital,

location_facility: Gottsegen György Országos Kardiológiai Intézet (Hungarian Institute of Cardiology)

location_facility: University of Texas Medical Center - St. Paul University

location_facility: Harper Univ. Hospital/ Wayne State University

location_facility: Universitätsklinikum Hamburg-Eppendorf / Onkologie, Hämatologie und Knochenmarktransplantation mit Sektion Pneumologie

location_facility: Slovak Medical University (Slovenská zdravotnícka univerzita) / Faculty of Medical Speciality Studies (Fakulta zdravotníckych špecializačných štúdií)

location_facility: Klinika Chorob Serca i Naczyn Instytut Kardiologii Collegium Medicum UJ

location_facility: Lady Davis Carmel Medical Center / Department of Cardiovascular Medicine, Pulmonary Division

location_facility: University of Maryland School of Medicine; Division of Cardiology

location_facility: III Katedra i Oddział Kliniczny Kardiologii Slaskiego Uniwersytetu Medycznego

location_facility: Medizinische Klinik und Poliklinik I Universitätsklinikum Carl Gustav Carus

location_facility: Sourasky Medical Center - Division of Pulmonary Medicine and Allergy

location_facility: IRCCS Policlinico San Matteo Policlinico / Dipartimento di Cardiologia

location_facility: Institutul de Pneumologie "Marius Nasta" / I. Clinica de Pneumoftiziologie

location_facility: Maharaj Nakorn Chiang Mai Hospital, Division of Rheumatology

location_facility: University of Florida - Division of Pulmonology

location_facility: Medizinische Klinik und Poliklinik I der Ludwig-Maximilians-Universität München / Klinikum Großhadern, Schwerpunkt Pneumologie

location_facility: Washington University School of Medicine

location_facility: VU Medisch Centrum, Dept. Pulmonology 4A 48

location_facility: P D Hinduja National Hospital and Medical Research Centre/ Pulmunory Medicine

location_facility: Municipal Health Care Institution "Clinical Hospital of Emergency Care named after N.V. Soloviov"

location_facility: Seth GS Medical College & King Edward VII Memorial (KEM) Hospital / Department Of Cardiology

location_facility: University of Cincinnati Ohio Heart Health Center

location_facility: Emory University Hospital - McKelvey Center for Lung Transplantation & Pulmonary Vascular Disease

location_facility: University of NJ - Robert Wood Johnson Medical School

location_facility: Unfallkrankenhaus Berlin, Klinik für Innere Medizin

location_facility: G B Pant Hospital & Maulana Azad Medical College

location_facility: National Institute of Cardiovascular Diseases (Slovenska zdravotnicka univerzita) / Faculty of Medical Specialty Studies (Fakulta zdravotnickych speci

location_facility: Prince of Wales Hospital/ Division of Rheumatology, Department of Medicine & Therapeutics

location_facility: Universitätsklinikums Gießen und Marburg GmbH / Medizinische Klinik und Poliklinik II, Innere Med. / Pneumologie

location_facility: National Taiwan University Hospital/ Thoracic Surgical Division, Surgical Department

location_facility: Universität Greifswald / Klinik für Innere Medizin B,

location_facility: Republican reserach - Pratical Centre of Cardiology

location_facility: Chris Hani Baragwanath Hospital, Department of Cardiology

location_facility: Columbia University Medical Center - Pediatric Cardiology

location_facility: Rambam Health Care Campus / Division of Medicine, Institute of Pulmonology

location_facility: Shanghai Pulmonary Hospital Department of Pulmonary Circulation

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: Pulmonary Institute, Kaplan Medical Center

location_facility: Hopital Arnaud de Villeneuve Service des Maladies Respiratoires

location_facility: Jiangsu Province Hospital - Pneumology Department

location_facility: Hospital Alberto Sabogal Sologuren - EsSALUD

location_facility: Odessa State Medical University, Military-medical Clinical Center of the South region

location_facility: Guangdong General Hospital, Cardiology Department

location_facility: State Institution "Scientific Research Institute of Cardiology" of Tomsk Scientific Center of RAMS, Siberian branch

location_facility: University Clinical Center of Serbia/ Institute for Lung Diseases and Tuberculosis

location_facility: State Educational Institution of High Professional Education "St Petersburg State Medical

location_facility: State Educational Institution "St Petersburg Medical Academy of Postgraduate Education" of Federal Agency of Public Health and Social Development

location_facility: Pontificia Universidad Catolica de Chile

location_facility: Medizinische Hochschule Hannover / Klinik für Pneumologie

location_facility: Universität zu Köln, Medizinische Klinik III, Abteilung Kardiologie

location_facility: Hospital Italiano - Garibaldi de Rosario

location_facility: State Health Care Institution of Moscow "City Clinical Hospital #1 named after N. I. Pirogov"

location_facility: Universitätskliniken des Saarlandes / Medizinische Klinik und Poliklinik, Innere Medizin V

location_facility: Hopital Haut-Leveque-Maison du Haut-Leveque

location_facility: Institut Jantung Negara (National Heart Institute)

location_facility: "Semmelweis Egyetem, Pulmonológiai Klinika"

location_facility: Institutul de boli cardiovasculare / Clinica de Cardiologie

location_facility: Universitatsklinikum Regensburg/Innere Medizin II

location_facility: Life Care Institute of Medical Science & Research, Ahmedabad

location_facility: Federal State Institution "Federal Center of Heart, Blood and Endocrinology named after V.A. Almazov" of Rosmedtechnology

study_completion_date_type: Actual

title: Long-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension

summary: The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.

status_simplified: Completed


title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension

acronym: SERAPHIN

summary: The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two different doses of macitentan (ACT-064992) (3 and 10 mg) vs placebo in patients with symptomatic PAH. The main study objective is to demonstrate that macitentan (ACT-064992) prolongs time to the first morbidity or mortality event, and to evaluate the benefit/risk profile of macitentan (ACT-064992) in the treatment of patients with symptomatic PAH.

ReferenceType: result

ReferenceCitation: Pulido T, Adzerikho I, Channick RN, Delcroix M, Galiè N, Ghofrani HA, Jansa P, Jing ZC, Le Brun FO, Mehta S, Mittelholzer CM, Perchenet L, Sastry BK, Sitbon O, Souza R, Torbicki A, Zeng X, Rubin LJ, Simonneau G; SERAPHIN Investigators. Macitentan and morbidity and mortality in pulmonary arterial hypertension. N Engl J Med. 2013 Aug 29;369(9):809-18. doi: 10.1056/NEJMoa1213917.

family: Pulido

full_name: Tomás Pulido

given: Tomás

family: Adzerikho

full_name: Igor Adzerikho

given: Igor

family: Channick

full_name: Richard N. Channick

given: Richard N.

family: Delcroix

full_name: Marion Delcroix

given: Marion

family: Galiè

full_name: Nazzareno Galiè

given: Nazzareno

family: Ghofrani

full_name: Hossein-Ardeschir Ghofrani

given: Hossein-Ardeschir

family: Jansa

full_name: Pavel Jansa

given: Pavel

family: Jing

full_name: Zhi-Cheng Jing

given: Zhi-Cheng

family: Le Brun

full_name: Franck-Olivier Le Brun

given: Franck-Olivier

family: Mehta

full_name: Sanjay Mehta

given: Sanjay

family: Mittelholzer

full_name: Camilla M. Mittelholzer

given: Camilla M.

family: Perchenet

full_name: Loïc Perchenet

given: Loïc

family: Sastry

full_name: B.K.S. Sastry

family: Sitbon

full_name: Olivier Sitbon

given: Olivier

family: Souza

full_name: Rogério Souza

given: Rogério

family: Torbicki

full_name: Adam Torbicki

given: Adam

family: Zeng

full_name: Xiaofeng Zeng

given: Xiaofeng

family: Rubin

full_name: Lewis J. Rubin

given: Lewis J.

family: Simonneau

full_name: Gérald Simonneau

given: Gérald

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Macitentan and Morbidity and Mortality in Pulmonary Arterial Hypertension

ReferenceCitation: Torbicki A, Bacchi M, Delcroix M, Farber HW, Ghofrani HA, Hennessy B, Jansa P, Mehta S, Perchenet L, Pulido T, Rosenberg D, Rubin LJ, Sastry BKS, Simonneau G, Sitbon O, Souza R, Wei LJ, Channick R, Benza R. Integrating Data From Randomized Controlled Trials and Observational Studies to Assess Survival in Rare Diseases. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005095. doi: 10.1161/CIRCOUTCOMES.118.005095.

name: Department of Pulmonary Circulation and Thromboembolic Diseases and Cardiology, Centre of Postgraduate Medical Education, European Health Centre, ECZ-Otwock, Poland (A.T.).

name: Biostatistics, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland (M.B., B.H.).

family: Bacchi

full_name: Marisa Bacchi

given: Marisa

name: Department of Pneumology, University Hospitals Leuven, Belgium (M.D.).

name: Pulmonary Center, Boston University School of Medicine, MA (H.W.F.).

name: University of Giessen and Marburg Lung Center, Germany, member of the German Center of Lung Research, and Department of Medicine, Imperial College London, United Kingdom (H.-A.G.).

name: Clinicial Department of Cardiology and Angiology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic (P.J.).

name: Canada Respirology Division, London Health Sciences Centre, ON (S.M.).

name: Global Medical Affairs, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland (L.P.).

name: Cardiopulmonary Department, Ignacio Chávez National Heart Institute, Mexico City, Mexico (T.P.).

name: Epidemiology & Observational Studies, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland (D.R.).

name: Division of Pulmonary and Critical Care Medicine, University of California, San Diego Medical School (L.J.R.).

name: Division of Cardiology, CARE Hospitals, Hyderabad, India (B.K.S.S.).

name: APHP Centre de Référence de l'Hypertension Pulmonaire, Service de Pneumologie et Soins Intensifs, Université Paris-Sud, Hôpital de Bicêtre, Le Kremlin-Bicêtre, France (G.S., O.S.).

name: INCOR Heart Institute, University of Sao Paulo, Brazil (R.S.).

name: Department of Biostatistics, Harvard University, Boston, MA (L.-J.W.).

name: University of California Los Angeles (R.C.).

name: Division of Cardiovascular Diseases, Allegheny General Hospital, Pittsburgh, PA (R.B.).

journal_name: Circulation: Cardiovascular Quality and Outcomes

title: Modeling of pharmacokinetics, efficacy, and hemodynamic effects of macitentan in patients with pulmonary arterial hypertension

ReferenceCitation: McLaughlin VV, Hoeper MM, Channick RN, Chin KM, Delcroix M, Gaine S, Ghofrani HA, Jansa P, Lang IM, Mehta S, Pulido T, Sastry BKS, Simonneau G, Sitbon O, Souza R, Torbicki A, Tapson VF, Perchenet L, Preiss R, Verweij P, Rubin LJ, Galiè N. Pulmonary Arterial Hypertension-Related Morbidity Is Prognostic for Mortality. J Am Coll Cardiol. 2018 Feb 20;71(7):752-763. doi: 10.1016/j.jacc.2017.12.010.

repositories_institution:
INFN Catania - INFM-OAR
KU Leuven - Lirias

ReferenceCitation: Jansa P, Pulido T. Macitentan in Pulmonary Arterial Hypertension: A Focus on Combination Therapy in the SERAPHIN Trial. Am J Cardiovasc Drugs. 2018 Feb;18(1):1-11. doi: 10.1007/s40256-017-0260-1. Review.

journal_name: American Journal of Cardiovascular Drugs

ReferenceCitation: Mehta S, Sastry BKS, Souza R, Torbicki A, Ghofrani HA, Channick RN, Delcroix M, Pulido T, Simonneau G, Wlodarczyk J, Rubin LJ, Jansa P, Hunsche E, Galiè N, Perchenet L, Sitbon O. Macitentan Improves Health-Related Quality of Life for Patients With Pulmonary Arterial Hypertension: Results From the Randomized Controlled SERAPHIN Trial. Chest. 2017 Jan;151(1):106-118. doi: 10.1016/j.chest.2016.08.1473. Epub 2016 Sep 23. Erratum in: Chest. 2018 May;153(5):1287.

ReferenceCitation: Simonneau G, Channick RN, Delcroix M, Galiè N, Ghofrani HA, Jansa P, Le Brun FO, Mehta S, Perchenet L, Pulido T, Sastry BK, Sitbon O, Souza R, Torbicki A, Rubin LJ. Incident and prevalent cohorts with pulmonary arterial hypertension: insight from SERAPHIN. Eur Respir J. 2015 Dec;46(6):1711-20. doi: 10.1183/13993003.00364-2015. Epub 2015 Oct 22.

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

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

ReferenceCitation: Channick RN, Delcroix M, Ghofrani HA, Hunsche E, Jansa P, Le Brun FO, Mehta S, Pulido T, Rubin LJ, Sastry BKS, Simonneau G, Sitbon O, Souza R, Torbicki A, Galiè N. Effect of macitentan on hospitalizations: results from the SERAPHIN trial. JACC Heart Fail. 2015 Jan;3(1):1-8. doi: 10.1016/j.jchf.2014.07.013. Epub 2014 Nov 11.

title: Effect of Macitentan on Hospitalizations

location_country:
Peru
Malaysia
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
India
Spain
Croatia
France
Poland
Slovakia
Thailand
Norway
Argentina
Canada
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Bulgaria
Singapore
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Serbia
Mexico
Israel
Belarus
Turkey

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: IInstituto de Enfermedades Respiratorias, Clinica San Gabriel

location_facility: Hospital Clínico I Provincial, Servicio de Neumología.

location_facility: Srinagarind Hospital/Division of Rheumatology, Department of Medicine, Faculty of Medicine, Khon Kaen University

location_facility: Servicio de Medicina Interna, Unidad de Hipertensión Pulmonar

location_facility: Ramathibodi Hospital, Mahidol University, Cardiology Unit, Department of Medicine,

location_facility: Beijing Anzhen Hospital of the Capital University of Medical Sciences, Cardiology Department

location_facility: Hospital Universitario Vall d'Hebron, Pneumology Unit, Planta Baja Hospital General

location_facility: 'Pontificia Universidad Catolica de Chile

location_facility: Universitätsklinikum Regensburg / Innere Medizin II

location_facility: National University Hospital/ The Heart Institute

location_facility: London Health Sciences Centre / Victoria Hospital

location_facility: Rabin Medical Center - Belinson campus - Pulmonary Institute

location_facility: Netcare Milpark Hospital,Center for Chest Disease

location_facility: Federal State Institution "Russian Cardiology Scientific and Production Complex of Rosmedtechnology"

location_facility: Danylo Halytskyi Lviv State Medical University

location_facility: Zhongshan Hospital Fudan University, Cardiology Dept

location_facility: Republican reserach - Pratical Centre of Cardilogy

location_facility: Hospital Juan Canalejo Servicio de Neumología

location_facility: Federal State Institution "Scientific Research Institute of Pulmonology of Roszdrav"

location_facility: Chinese PLA General Hospital (301 Hospital), Cardiology Department

location_facility: Dnipropetrovsk State Medical Academy / Regional Diagnostic Center, Department of electrophysiologic researches and anaesthesiologic aid

location_facility: Chiang Mai Hospital / Division of Rheumatology, Department of Medicine, Faculty of Medicine, Chiang Mai University

location_facility: Slovak Medical University (Slovenská zdravotnícka univerzita) / Faculty of Medical Speciality Studies (Fakulta zdravotníckych špecializačných štúdií), Department of Cardiology and Angiology

location_facility: Pulmonary/Critical Care Division/Tufts New England Medical Center

location_facility: University Children's Hospital (UNIVERZITETSKA DEČJA KLINIKA)

location_facility: Medical Center of Louisiana at New Orleans

location_facility: Peking Union Medcical College Hospital, Rheumatology Department

location_facility: Queen Mary Hospital / Division of Cardiology, Department of Medicine

location_facility: Zemun Clinical Hospital (Kliničko-bolnički centar "Zemun" ) / Department of Cardiology

location_facility: The pulmonary institute Sheba Medical centre

location_facility: Universitätsklinikums Gießen und Marburg GmbH / Medizinische Klinik und Poliklinik II, Innere Med.

location_facility: 'Hospital Italiano - Garibaldi de Rosario

location_facility: Klinikum der Johannes Gutenberg-Universität / II. Medizinische Klinik und Poliklinik

location_facility: Tomsk Regional Clinical Hospital / Pulmonology Unit

location_facility: Medical University of Vienna/ Department of Internal Medicine II, Division of Cardiology

location_facility: Sverdlovsk Regional Clinical Hospital # 1/ Cardiology Department (2nd Therapy Department)

location_facility: Hopital Haut-Leveque - Maison du Haut-Leveque

location_facility: Dept. of Pulmonary Medicine - Latter Day Saints Hospital

location_facility: Gottsegen György Országos Kardiológiai Intézet (Hungarian Institute of Cardiology)

location_facility: University of Texas Medical Center - St. Paul University

location_facility: Universitätsklinikum Hamburg-Eppendorf / Onkologie, Hämatologie und Knochenmarktransplantation mit Sektion Pneumologie

location_facility: Specialized Hospital for Active Treatment of Cardio-Vascular Diseases / Department of Pediatric Cardiology

location_facility: Klinika Chorob Serca i Naczyn Instytut Kardiologii Collegium Medicum UJ

location_facility: Lady Davis Carmel Medical Center / Department of Cardiovascular Medicine, Pulmonary Division

location_facility: University of Maryland School of Medicine

location_facility: National Institute of Cardiovascular Diseases (Národný ústav srdcových a cievnych chorôb, a.s. - NÚSCH) / Department of Heart Transplantation

location_facility: III Katedra i Oddział Kliniczny Kardiologii Slaskiego Uniwersytetu Medycznego

location_facility: Hôpital Arnaud de Villeneuve Service des Maladies Respiratoires

location_facility: Medizinische Klinik und Poliklinik I Universitätsklinikum Carl Gustav Carus

location_facility: Sourasky Medical Center - Division of Pulmonary Medicine and Allergy

location_facility: Institutul de Pneumologie "Marius Nasta" / I. Clinica de Pneumoftiziologie

location_facility: University of Colorado Health Sciences Center

location_facility: University of Szeged Albert Szent-Györgyi Medical and Pharmaceutical Center, Faculty of General Medicine, II. Internal Medicine Clinic, Cardiology Center

location_facility: University Hospital Gasthuisberg / Kliniekhoofd, Interne Geneeskunde - I.G. Pneumologie

location_facility: Sentara Hospital T/A Sentara Cardiovascular Research Institute

location_facility: Medizinische Klinik und Poliklinik I der Ludwig-Maximilians-Universität München / Klinikum Großhadern, Schwerpunkt Pneumologie

location_facility: University Hospital in Lund, Heart and Lung Division

location_facility: Washington University School of Medicine

location_facility: P D Hinduja National Hospital and Medical Research Centre/ Pulmunory Medicine

location_facility: Shanghai Pulmonary Hospital, Dept of Pulmonary Circulation

location_facility: Municipal Health Care Institution "Clinical Hospital of Emergency Care named after N.V. Soloviov"

location_facility: King Edward VII Memorial Hospital (KEM) Hospital

location_facility: University of Cincinnati Ohio Heart Health Center

location_facility: Emory University Hospital - McKelvey Center for Lung Transplantation & Pulmonary Vascular Disease

location_facility: University of NJ - Robert Wood Johnson Medical School

location_facility: Unfallkrankenhaus Berlin, Klinik für Innere Medizin

location_facility: G B Pant Hospital & Maulana Azad Medical College

location_facility: Prince of Wales Hospital/ Division of Rheumatology, Department of Medicine & Therapeutics

location_facility: Siriraj Hospital/ Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University

location_facility: Baylor College of Medicine and the Methodist Hospital

location_facility: University Clinical Center of Serbia / Institute for Lung Diseases and Tuberculosis

location_facility: National Taiwan University Hospital/ Thoracic Surgical Division, Surgical Department

location_facility: Universität Greifswald / Klinik für Innere Medizin B,

location_facility: Chris Hani Baragwanath Hospital, Department of Cardiology

location_facility: Columbia University Medical Center - Pediatric Cardiology

location_facility: 'Instituto Nacional de Cardiología (INC) Ignacio Chávez

location_facility: State Educational Institution of High Professional Education

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: Pulmonary Institute, Kaplan Medical Center

location_facility: Hospital Clínico Virgen de la Victoria / Pneumology Unit,

location_facility: Jiangsu Province Hospital - Pneumology Department

location_facility: Hospital Alberto Sabogal Sologuren - EsSALUD

location_facility: Municipal Health Care Institution "Kemerovo Cardiology Dispensary"

location_facility: Guangdong General Hospital, Cardiology Department

location_facility: State Institution "Scientific Research Institute of Cardiology" of Tomsk Scientific Center of RAMS, Siberian branch

location_facility: Unidad de Investigación Clinica en Medicina, SC

location_facility: Hospital 12 Octubre/ Cardiology department Planta 5a.

location_facility: Istanbul University Cardiology Institure

location_facility: Hôpital Antoine Béclère / Service de Pneumologie

location_facility: Hospital Montecelo, Servicio de Neumología

location_facility: Taichung Veterans General Hospital / Division of Allergy, Immunology and Rheumatology

location_facility: Klinika Chorób Wewnętrznych Klatki Piersiowej

location_facility: Semmelweis University, Pulmonolgy Clinic


ReferenceCitation: Laine L, Katz PO, Johnson DA, Ibegbu I, Goldstein MJ, Chou C, Rossiter G, Lu Y. Randomised clinical trial: a novel rabeprazole extended release 50 mg formulation vs. esomeprazole 40 mg in healing of moderate-to-severe erosive oesophagitis - the results of two double-blind studies. Aliment Pharmacol Ther. 2011 Jan;33(2):203-12. doi: 10.1111/j.1365-2036.2010.04516.x. Epub 2010 Nov 30.

family: Laine

full_name: L. Laine

given: L.

family: Katz

full_name: P. O. Katz

given: P. O.

family: Johnson

full_name: D. A. Johnson

given: D. A.

family: Ibegbu

full_name: I. Ibegbu

given: I.

family: Goldstein

full_name: M. J. Goldstein

given: M. J.

family: Chou

full_name: C. Chou

given: C.

family: Rossiter

full_name: G. Rossiter

given: G.

family: Lu

full_name: Y. Lu

given: Y.

journal_name: Alimentary Pharmacology & Therapeutics

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Eisai Inc.

location_country:
United States
Chile
India
Germany
Croatia
Bulgaria
France
Lithuania
Hungary
Argentina
Australia
Estonia
Canada
Latvia

acronym: Not applicable

title: A Randomized, Double-Blind, Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)

summary: The purpose of this study is to investigate the efficacy (ie, healing and symptom relief) and safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).


title: A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate

summary: This study will evaluate the efficacy and safety of two dosing regimens of a compound known as TRU-015 in combination with methotrexate (MTX) in patients with active rheumatoid arthritis.

lead_sponsor: Pfizer

location_country:
United States
Serbia
Mexico
Netherlands
Germany
France
Romania
Hungary
Belgium
Canada


title: An Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169

summary: To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with early and advanced Parkinson's disease

design_allocation: Non-Randomized

ReferenceCitation: Makumi CW, Asgharian A, Ellis J, Shaikh S, Jimenez T, VanMeter S. Long-term, open-label, safety study of once-daily ropinirole extended/prolonged release in early and advanced Parkinson's disease. Int J Neurosci. 2016;126(1):30-8. doi: 10.3109/00207454.2014.991924. Epub 2014 Dec 27.

family: Makumi

full_name: Clare W. Makumi

given: Clare W.

family: Asgharian

full_name: Afsaneh Asgharian

given: Afsaneh

family: Ellis

full_name: Jeffrey Ellis

given: Jeffrey

family: Shaikh

full_name: Soraya Shaikh

given: Soraya

family: Jimenez

full_name: Teri Jimenez

given: Teri

family: VanMeter

full_name: Susan VanMeter

given: Susan

journal_name: International Journal of Neuroscience

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
United Kingdom
France
Poland
Hungary
Belgium
Spain
United States
Czech Republic


title: Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)

acronym: BUILD OL

summary: This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF).

location_country:
Italy
United States
Switzerland
United Kingdom
Germany
France
Japan
Israel
Ireland
Belgium
Australia
Spain
Canada
Czech Republic
Korea, Republic of

location_facility: Azienda Sanitaria di Forli-Presidio Ospedaliero Stabilimento

location_facility: St. Vincent's Public Hospital, Lung Transplantation & Respiratory Medicine

location_facility: Klinik Donaustauf-Zentrum für Pneumologie

location_facility: Lungenfachklinik Immenhausen; Pneumologische Lehrklinik der Universität Göttingen

location_facility: SKlinikum der Universität München Medizinische Klinik und Poliklinik 1 - Grosshadern

location_facility: Inselspital Bern-Div of Pulmonary Medicine

location_facility: Kanagawa Cardiovascular Respiratory Center

location_facility: Fachkrankenhaus Coswig; Centre for Pumonology and Thoracic Surgery

location_facility: Sheba Medical Centre-Pulmonology Institute

location_facility: University Hospital Basel-Div of Pneumology

location_facility: Institut de Cardiologie et de Pneumologie de l'Universite Laval

location_facility: Hadassah medical Centrte: Ein Karem-Institue of Pulmonology

location_facility: The Health Care Corporation of St. John's-Eastern Health

location_facility: University of Texas-Southwestern Dallas-Div of Pulm & Critical Care Unit

location_facility: Justus-Liebig-Universitat Giessen-Zentrum für Innere Medizin

location_facility: National Jewish Medical & Research Center

location_facility: University of Pennsylvania Medical Center

location_facility: Toronto General Hospital-Rosedale Medical Center PFT Lab

location_facility: UCLA- Division of Pulmonary & Critcal Care

location_facility: Hospital Clinic Barcelona (Pneumology Service)

location_facility: Tel-Aviv Sourasky Medical Centre-Institute of Pulmonary & Allergy Diseases

location_facility: Pulmoary and Critical Care Medicine-Stanford University Medical Center

location_facility: Walter C. Mackenzie Health Sciences Centre-University of Alberta

location_facility: University Hospital Zurich-Clinic for Pneumology & Lung Transplant Program

location_facility: Prince Charles Hospital- Lung Transplant, Thoraic Dept.


title: An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement Therapy

summary:
Study TKT024EXT was a long-term, single-arm, open-label extension of Study TKT024, a one year Phase 2/Phase 3 registration study. The primary objective of this extension study was to collect long-term safety and clinical outcome data in Mucopolysaccharidosis II (MPS II), also known as Hunter Syndrome, from the Phase 2/Phase 3 Study TKT024. All patients enrolling into this study received weekly active treatment with idursulfase, the primary dosing regimen investigated in Study TKT024.

Hunter Syndrome is an X-linked recessive lysosomal storage disease caused by a deficiency of iduronate-2-sulfatase, an enzyme required to catabolize glycosaminoglycans (GAGS) in cells. As a result, GAGs accumulate in the lysosomes leading to cellular engorgement, organomegaly, tissue destruction, and organ system dysfunction. Hunter Syndrome is a rare disease with an estimated incidence of 1 in 162,000 live births.

ReferenceCitation: Muenzer J, Gucsavas-Calikoglu M, McCandless SE, Schuetz TJ, Kimura A. A phase I/II clinical trial of enzyme replacement therapy in mucopolysaccharidosis II (Hunter syndrome). Mol Genet Metab. 2007 Mar;90(3):329-37. Epub 2006 Dec 20.

ReferenceCitation: Muenzer J, Wraith JE, Beck M, Giugliani R, Harmatz P, Eng CM, Vellodi A, Martin R, Ramaswami U, Gucsavas-Calikoglu M, Vijayaraghavan S, Wendt S, Puga AC, Ulbrich B, Shinawi M, Cleary M, Piper D, Conway AM, Kimura A. A phase II/III clinical study of enzyme replacement therapy with idursulfase in mucopolysaccharidosis II (Hunter syndrome). Genet Med. 2006 Aug;8(8):465-73. Erratum in: Genet Med. 2006 Sep;8(9):599. Wendt, Suzanne [corrected to Wendt, Susanne]; Puga, Antonio [corrected to Puga, Ana Cristina]; Conway, Ann Marie [corrected to Conway, Anne Marie].

ReferenceCitation: Muenzer J, Beck M, Eng CM, Giugliani R, Harmatz P, Martin R, Ramaswami U, Vellodi A, Wraith JE, Cleary M, Gucsavas-Calikoglu M, Puga AC, Shinawi M, Ulbrich B, Vijayaraghavan S, Wendt S, Conway AM, Rossi A, Whiteman DA, Kimura A. Long-term, open-labeled extension study of idursulfase in the treatment of Hunter syndrome. Genet Med. 2011 Feb;13(2):95-101. doi: 10.1097/GIM.0b013e3181fea459. Erratum in: Genet Med. 2013 Oct;15(10):849.

family: Muenzer

full_name: Joseph Muenzer

given: Joseph

family: Beck

full_name: Michael Beck

given: Michael

family: Eng

full_name: Christine M Eng

given: Christine M

family: Giugliani

full_name: Roberto Giugliani

given: Roberto

family: Harmatz

full_name: Paul Harmatz

given: Paul

family: Martin

full_name: Rick Martin

given: Rick

family: Ramaswami

full_name: Uma Ramaswami

given: Uma

family: Vellodi

full_name: Ashok Vellodi

given: Ashok

family: Wraith

full_name: James E Wraith

given: James E

family: Cleary

full_name: Maureen Cleary

given: Maureen

family: Gucsavas-Calikoglu

full_name: Muge Gucsavas-Calikoglu

given: Muge

family: Puga

full_name: Ana Cristina Puga

given: Ana Cristina

family: Shinawi

full_name: Marwan Shinawi

given: Marwan

family: Ulbrich

full_name: Birgit Ulbrich

given: Birgit

family: Vijayaraghavan

full_name: Suresh Vijayaraghavan

given: Suresh

family: Wendt

full_name: Susanne Wendt

given: Susanne

family: Conway

full_name: Anne Marie Conway

given: Anne Marie

family: Rossi

full_name: Alexandra Rossi

given: Alexandra

family: Whiteman

full_name: David A H Whiteman

given: David A H

family: Kimura

full_name: Alan Kimura

given: Alan

journal_name: Genetics in Medicine

oa_host_type: publisher

evidence: open (via free pdf)

ReferenceCitation: Beusterien KM, Yeung JE, Pang F, Brazier J. Development of the multi-attribute Adolescent Health Utility Measure (AHUM). Health Qual Life Outcomes. 2012 Aug 28;10:102.

location_country:
Italy
Brazil
Sweden
Germany
France
Romania
Spain
United States
United Kingdom
Canada

location_facility: University of Montreal / Hopital Ste-Justine

location_facility: Universita degli Studi di Napoli Federico II

location_facility: Fundacao Universidade de Ciencias da Saude de Alagoas Governador Lamenha Filho / UNCISAL

location_facility: Instituto da Crianca / Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: University of North Carolina at Chapel Hill

location_facility: Universita Milano Bicocca / Ospedale S. Gerardo

location_facility: The Hospital for Sick Children Research Institute

location_facility: Hospital de Clinicas de Porto Alegre, Servico de Genetica Medica

location_facility: Pediatric Clinical Research Center, Children's Hospital Oakland

location_facility: University of Iowa Hospitals and Clinics

location_facility: Mid-Illinois Hematology and Oncology Associates

location_facility: Baylor College of Medicine Texas Children's Hospital

location_facility: Instituto de Puericultura e Pediatria Martagao Gesteira / Hospital Pediatrico

location_facility: Upstate Medical University, State University of New York (SUNY)

location_facility: Great Ormond Street Hospital for Sick Children

location_facility: Saint Louis University Cardinal Glennon Children's Hospital

location_facility: University Hospital Germans Trias i Pujol

location_facility: Hospital Universitario da Faculdade de Medicina da Universidade Federal de Mato Grosso do Sul

location_facility: UNIFESP Instituto de Oncologia Pediatrica


title: Comparison of Supplemental Oxygen and Nitric Oxide for Inhalation Plus Oxygen in the Evaluation of the Reactivity of the Pulmonary Vasculature During Acute Pulmonary Vasodilator Testing

summary: The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.

primary_purpose: Diagnostic

ReferenceCitation: Barst RJ, Agnoletti G, Fraisse A, Baldassarre J, Wessel DL; NO Diagnostic Study Group. Vasodilator testing with nitric oxide and/or oxygen in pediatric pulmonary hypertension. Pediatr Cardiol. 2010 Jul;31(5):598-606. doi: 10.1007/s00246-010-9645-5. Epub 2010 Apr 20.

family: Barst

full_name: Robyn J. Barst

given: Robyn J.

family: Agnoletti

full_name: Gabriella Agnoletti

given: Gabriella

family: Fraisse

full_name: Alain Fraisse

given: Alain

family: Baldassarre

full_name: James Baldassarre

given: James

family: Wessel

full_name: David L. Wessel

given: David L.

journal_name: Pediatric Cardiology

publisher_dissemination: Springer

publisher_group: Springer

title: Vasodilator Testing with Nitric Oxide and/or Oxygen in Pediatric Pulmonary Hypertension

ipd_sharing: No

lead_sponsor: Mallinckrodt

location_country:
Netherlands
France
Spain
United States
United Kingdom

location_facility: Lucile Salter Packard Children's Hospital at Stanford

location_facility: Instituto Pediátrico del Corazón - Hospital Materno Infatil Doce de Octubre

location_facility: Beatrix Children's Hospital / University Hospital Groningen

location_facility: Southampton University Hospitals Trust - Wessex Cardiothoracic Centre

location_facility: The Medical University of South Carolina

location_facility: Unidad de Cardiologia Infantil - Hospital Vall d'Hebrón


lead_sponsor: AbbVie (prior sponsor, Abbott)

location_country:
Italy
Austria
United States
Sweden
Switzerland
Germany
Finland
France
Greece
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility:
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title: A Phase 3, Multi-center, Open-label Continuation Study in Moderate to Severe Plaque Psoriasis in Subjects Who Completed a Preceding Psoriasis Study With ABT-874

summary: The purpose of this study is to evaluate long term safety, efficacy and tolerability of ABT-874 in adults with moderate to severe psoriasis.


title: Randomized, Double-blind, Placebo-controlled add-on Trial of the Safety and Efficacy of RO4917838 in Outpatients on Select Atypical Antipsychotics With Prominent Negative or Disorganized Thought Symptoms

summary: This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone, paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms. After a 4 week run in period on their current anti psychotic treatment, patients will be randomized to receive placebo 10mg, 30mg, or 60mg of RO4917838 once daily, p.o., as add-on therapy. The anticipated time o n study treatment is <3 months, and the target sample size is 100-500 individual s.

ReferenceCitation: Umbricht D, Alberati D, Martin-Facklam M, Borroni E, Youssef EA, Ostland M, Wallace TL, Knoflach F, Dorflinger E, Wettstein JG, Bausch A, Garibaldi G, Santarelli L. Effect of bitopertin, a glycine reuptake inhibitor, on negative symptoms of schizophrenia: a randomized, double-blind, proof-of-concept study. JAMA Psychiatry. 2014 Jun;71(6):637-46. doi: 10.1001/jamapsychiatry.2014.163.

family: Umbricht

full_name: Daniel Umbricht

given: Daniel

family: Alberati

full_name: Daniela Alberati

given: Daniela

family: Martin-Facklam

full_name: Meret Martin-Facklam

given: Meret

family: Borroni

full_name: Edilio Borroni

given: Edilio

family: Youssef

full_name: Eriene A. Youssef

given: Eriene A.

family: Ostland

full_name: Michael Ostland

given: Michael

name: SRI International, Menlo Park, California

family: Wallace

full_name: Tanya L. Wallace

given: Tanya L.

family: Knoflach

full_name: Frédéric Knoflach

given: Frédéric

family: Dorflinger

full_name: Ernest Dorflinger

given: Ernest

family: Wettstein

full_name: Joseph G. Wettstein

given: Joseph G.

name: F. Hoffmann-La Roche, Basel, Switzerland3now with Support Venture, Riehen, Switzerland

family: Bausch

full_name: Alexander Bausch

given: Alexander

family: Garibaldi

full_name: George Garibaldi

given: George

family: Santarelli

full_name: Luca Santarelli

given: Luca

journal_name: JAMA Psychiatry

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Effect of Bitopertin, a Glycine Reuptake Inhibitor, on Negative Symptoms of Schizophrenia

lead_sponsor: Hoffmann-La Roche

location_country:
Austria
Brazil
Mexico
Germany
France
Japan
Poland
Hungary
Russian Federation
United States


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study To Investigate The Safety And Efficacy Of CP-690,550 In Subjects With Moderate To Severe Crohn's Disease.

summary: This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one of the dose levels to be tested will be more effective than placebo (inactive drug).

ReferenceCitation: Sandborn WJ, Ghosh S, Panes J, Vranic I, Wang W, Niezychowski W; Study A3921043 Investigators. A phase 2 study of tofacitinib, an oral Janus kinase inhibitor, in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Sep;12(9):1485-93.e2. doi: 10.1016/j.cgh.2014.01.029. Epub 2014 Jan 27.

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Ghosh

full_name: Subrata Ghosh

given: Subrata

family: Panes

full_name: Julian Panes

given: Julian

family: Vranic

full_name: Ivana Vranic

given: Ivana

family: Wang

full_name: Wenjin Wang

given: Wenjin

family: Niezychowski

full_name: Wojciech Niezychowski

given: Wojciech

family: Vermeire

full_name: Severine A.R.A. Vermeire

given: Severine A.R.A.

family: Dewit

full_name: Olivier Dewit

given: Olivier

family: Peeters

full_name: Harald Peeters

given: Harald

family: Stehlik

full_name: Jiri Stehlik

given: Jiri

family: Vanasek

full_name: Tomas Vanasek

given: Tomas

family: Laharie

full_name: David Laharie

given: David

family: Colombel

full_name: Jean Frederic Colombel

given: Jean Frederic

family: Bigard

full_name: Marc-André Bigard

given: Marc-André

family: Varga

full_name: Marta Varga

given: Marta

family: Zeher

full_name: Margit Zeher

given: Margit

family: Novak

full_name: Janos Novak

given: Janos

family: Hunyady

full_name: Bela Hunyady

given: Bela

family: Salamon

full_name: Agnes Salamon

given: Agnes

family: Racz

full_name: Istvan Racz

given: Istvan

family: Gionchetti

full_name: Paolo Gionchetti

given: Paolo

family: Kohn

full_name: Anna Kohn

given: Anna

family: Prantera

full_name: Cosimo Prantera

given: Cosimo

family: Stokkers

journal_name: Clinical Gastroenterology and Hepatology

title: A Phase 2 Study of Tofacitinib, an Oral Janus Kinase Inhibitor, in Patients With Crohn’s Disease

ReferenceCitation: Ghoreschi K, Jesson MI, Li X, Lee JL, Ghosh S, Alsup JW, Warner JD, Tanaka M, Steward-Tharp SM, Gadina M, Thomas CJ, Minnerly JC, Storer CE, LaBranche TP, Radi ZA, Dowty ME, Head RD, Meyer DM, Kishore N, O'Shea JJ. Modulation of innate and adaptive immune responses by tofacitinib (CP-690,550). J Immunol. 2011 Apr 1;186(7):4234-43. doi: 10.4049/jimmunol.1003668. Epub 2011 Mar 7.

publisher: The American Association of Immunologists

title: Modulation of Innate and Adaptive Immune Responses by Tofacitinib (CP-690,550)

location_country:
Italy
South Africa
United Kingdom
Netherlands
France
Poland
Slovakia
Hungary
Belgium
Spain
United States
Czech Republic


title: A Multi-center, Long-term, Open-label Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia

summary: To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia

location_country:
United States
South Africa
Sweden
Netherlands
Germany
France
Czechia
Belgium
Canada
United Kingdom
Korea, Republic of


title: A Randomized, Parallel Group, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects With Rheumatoid Arthritis Having an Inadequate Response to Methotrexate

summary: The purpose of this study is to find out if 300 mg of BMS-582949 given once daily will be more effective than placebo after 12 weeks of treatment in subjects with rheumatoid arthritis who are also taking methotrexate

lead_sponsor: Bristol-Myers Squibb

location_country:
Mexico
France
Argentina
Spain
United States
Czech Republic
Korea, Republic of
Taiwan

location_facility:
Orrin M. Troum,M D
Tacoma Center For Arthritis Research Ps
G. Timothy Kelly, Md
Desert Medical Advances
The Arthritis Group
Health Research Of Oklahoma
Walter F Chase Md
Arthritis Clinic
Local Institution


title: Randomized Phase 2 Trial Of AG013736 Or Bevacizumab In Combination With Paclitaxel And Carboplatin As First Line Treatment For Patients With Advanced Non Small Cell Lung Cancer

summary: To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with advanced lung cancer who have not been previously treated.

ReferenceCitation: Twelves C, Chmielowska E, Havel L, Popat S, Swieboda-Sadlej A, Sawrycki P, Bycott P, Ingrosso A, Kim S, Williams JA, Chen C, Olszanski AJ, de Besi P, Schiller JH. Randomised phase II study of axitinib or bevacizumab combined with paclitaxel/carboplatin as first-line therapy for patients with advanced non-small-cell lung cancer. Ann Oncol. 2014 Jan;25(1):132-8. doi: 10.1093/annonc/mdt489.

family: Twelves

full_name: C. Twelves

given: C.

family: Chmielowska

full_name: E. Chmielowska

given: E.

family: Havel

full_name: L. Havel

given: L.

family: Popat

full_name: S. Popat

given: S.

family: Swieboda-Sadlej

full_name: A. Swieboda-Sadlej

given: A.

family: Sawrycki

full_name: P. Sawrycki

given: P.

family: Bycott

full_name: P. Bycott

family: Ingrosso

full_name: A. Ingrosso

family: Kim

full_name: S. Kim

family: Williams

full_name: J.A. Williams

family: Chen

full_name: C. Chen

family: Olszanski

full_name: A.J. Olszanski

family: de Besi

full_name: P. de Besi

family: Schiller

full_name: J.H. Schiller

journal_name: Annals of Oncology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

location_country:
United Kingdom
France
Poland
Spain
United States
Czech Republic


title: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Dose Ranging Study Evaluating the Efficacy and Safety of GW642444M Administered Once Daily Compared With Placebo for 28 Days in Adolescent and Adult Subjects With Persistent Asthma

summary: This study is designed to determine if the investigational drug is effective and safe in individuals with asthma

ReferenceCitation: Lötvall J, Bateman ED, Bleecker ER, Busse WW, Woodcock A, Follows R, Lim J, Stone S, Jacques L, Haumann B. 24-h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroids. Eur Respir J. 2012 Sep;40(3):570-9. doi: 10.1183/09031936.00121411. Epub 2012 Feb 23.

location_country:
United States
Chile
Peru
South Africa
Sweden
Netherlands
Philippines
Germany
France
Poland
Thailand
Belgium
Argentina
Russian Federation
Canada
Korea, Republic of


type: Other Identifier

title: An Open-Label Extension to the Double-Blind SP513 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease

summary: The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic Parkinson's disease

ReferenceCitation: Giladi N, Boroojerdi B, Surmann E. The safety and tolerability of rotigotine transdermal system over a 6-year period in patients with early-stage Parkinson's disease. J Neural Transm (Vienna). 2013 Sep;120(9):1321-9. doi: 10.1007/s00702-013-1001-5. Epub 2013 Mar 19.

family: Giladi

full_name: Nir Giladi

given: Nir

family: Boroojerdi

full_name: Babak Boroojerdi

given: Babak

family: Surmann

full_name: Erwin Surmann

given: Erwin

journal_name: Journal of Neural Transmission

title: The safety and tolerability of rotigotine transdermal system over a 6-year period in patients with early-stage Parkinson’s disease

lead_sponsor: UCB Pharma

location_country:
Italy
Austria
South Africa
Sweden
Switzerland
Netherlands
United Kingdom
Finland
Croatia
France
Poland
Israel
Norway
Hungary
Australia
Belgium
New Zealand
Spain
Germany
Czech Republic


ReferenceCitation: Shieh PB, Elfring G, Trifillis P, Santos C, Peltz SW, Parsons JA, Apkon S, Darras BT, Campbell C, McDonald CM; Members of the Ataluren Phase IIb Study Group †; Members of the Ataluren Phase IIb Study Clinical Evaluator Training Group ‡; Members of the ACT DMD Study Group ¶; Members of the ACT DMD Clinical Evaluator Training Group §. Meta-analyses of deflazacort versus prednisone/prednisolone in patients with nonsense mutation Duchenne muscular dystrophy. J Comp Eff Res. 2021 Oct 25. doi: 10.2217/cer-2021-0018. [Epub ahead of print]

name: University of California at Los Angeles, Los Angeles, CA, USA

family: Shieh

full_name: Perry B Shieh

given: Perry B

name: PTC Therapeutics, Inc., South Plainfield, NJ, USA

family: Elfring

full_name: Gary Elfring

given: Gary

family: Trifillis

full_name: Panayiota Trifillis

given: Panayiota

family: Santos

full_name: Claudio Santos

given: Claudio

family: Peltz

full_name: Stuart W Peltz

given: Stuart W

name: University of Colorado School of Medicine, Aurora, CO, USA

family: Parsons

full_name: Julie A Parsons

given: Julie A

family: Apkon

full_name: Susan Apkon

given: Susan

name: Boston Children’s Hospital, Boston, MA, USA

family: Darras

full_name: Basil T Darras

given: Basil T

name: Children’s Hospital – London Health Sciences Centre, University of Western Ontario, London, ON, Canada

family: Campbell

full_name: Craig Campbell

given: Craig

name: University of California Davis Health, Sacramento, CA, USA

family: McDonald

full_name: Craig M McDonald

given: Craig M

family: Barohn

full_name: Richard J Barohn

given: Richard J

family: Bertini

full_name: Enrico Bertini

given: Enrico

family: Bushby

full_name: Kate Bushby

given: Kate

family: Chabrol

full_name: Brigitte Chabrol

given: Brigitte

family: Ciafaloni

full_name: Emma Ciafaloni

given: Emma

family: Columer

full_name: Jaume Columer

given: Jaume

family: Comi

full_name: Giacomi Pietro Comi

given: Giacomi Pietro

family: Connolly

full_name: Anne Connolly

given: Anne

family: Finkel

full_name: Richard S Finkel

given: Richard S

family: Flanigan

full_name: Kevin M Flanigan

given: Kevin M

family: Goemans

full_name: Nathalie Goemans

given: Nathalie

family: Guglieri

full_name: Michela Guglieri

given: Michela

family: Iannaccone

full_name: Susan T Iannaccone

given: Susan T

family: Jones

full_name: Kristi J Jones

given: Kristi J

family: Kaufmann

full_name: Petra Kaufmann

given: Petra

full_name: Alexandra Prufer de Queiroz Campos Araujo

journal_name: Journal of Comparative Effectiveness Research

ReferenceCitation: Campbell C, Barohn RJ, Bertini E, Chabrol B, Comi GP, Darras BT, Finkel RS, Flanigan KM, Goemans N, Iannaccone ST, Jones KJ, Kirschner J, Mah JK, Mathews KD, McDonald CM, Mercuri E, Nevo Y, Péréon Y, Renfroe JB, Ryan MM, Sampson JB, Schara U, Sejersen T, Selby K, Tulinius M, Vílchez JJ, Voit T, Wei LJ, Wong BL, Elfring G, Souza M, McIntosh J, Trifillis P, Peltz SW, Muntoni F; PTC124-GD-007-DMD Study Group; ACT DMD Study Group; Clinical Evaluator Training Groups. Meta-analyses of ataluren randomized controlled trials in nonsense mutation Duchenne muscular dystrophy. J Comp Eff Res. 2020 Oct;9(14):973-984. doi: 10.2217/cer-2020-0095. Epub 2020 Aug 27.

name: Schulich School of Medicine & Dentistry, Western University, London, ON, N6A 5C1, Canada

name: University of Kansas Medical Center, Kansas City, KS 66160, USA

name: Bambino Gesù Children’s Research Hospital, Rome, 00146, Italy

name: Hôpital de la Timone, Unité de Médecine Infantile, Marseille, 13385, France

name: IRCCS Fondazione Ca'Granda Ospedale Maggiore Policlinico, Dino Ferrari Centre, Department of Pathophysiology & Transplantation, University of Milan, Milan, 20122, Italy

name: Boston Children’s Hospital, Harvard Medical School, Boston, MA 02115, USA

name: Children’s Hospital of Philadelphia, Philadelphia, PA 19104, USA

name: St. Jude Children’s Research Hospital, Memphis, TN 38105, USA

name: Nationwide Children’s Hospital, Columbus, OH 43205, USA

name: University Hospitals Leuven, KU Leuven, Leuven, 3000, Belgium

name: University of Texas Southwestern Medical Center, Dallas, TX 75390, USA

name: Kids Neuroscience, The Children’s Hospital at Westmead, Westmead, NSW, 2145, Australia

name: Department of Neuropediatrics & Muscle Disorders, Medical Center, University of Freiburg, Freiburg 79110, Germany

name: Department of Pediatrics, Division of Pediatric Neurology, Alberta Children’s Hospital, University of Calgary, Calgary, AB T3B 6A8, Canada

name: Departments of Pediatrics & Neurology, Division of Pediatric Neurology, University of Iowa Carver College of Medicine, Iowa City, IA 52242, USA

name: University of California Davis Health, Sacramento, CA 95817, USA

name: Department of Pediatric Neurology, Catholic University, Rome, 00168, Italy

name: Schneider Children’s Medical Center, Tel Aviv University, Tel Aviv, 6997801, Israel

name: Reference Centre for Neuromuscular Disorders AOC, Hôtel-Dieu, Nantes, 44000, France

name: Child Neurology Center of Northwest Florida, Gulf Breeze, FL 32561, USA

name: The Royal Children’s Hospital, Parkville, Victoria, 3052, Australia

name: Stanford University Medical Center, Department of Neurology & Neurological Sciences, Stanford, CA 94305, USA

name: Department of Pediatric Neurology, University Hospital Essen, University of Duisburg-Essen, Essen, 45122, Germany

name: Karolinska University Hospital, Karolinska Institutet, Stockholm, 171 76, Sweden

name: Division of Neurology, British Columbia Children’s Hospital, Vancouver, BC, V6H 3N1, Canada

name: Gothenburg University, Queen Silvia Children’s Hospital, Gothenburg, 416 85, Sweden

name: Hospital Universitario y Politécnico La Fe, CIBERER, Valencia, 46026, Spain

name: NIHR Great Ormond Street Hospital Biomedical Research Centre, University College London & UCL Great Ormond Street Institute of Child Health, Great Ormond Street Hospital Trust, London, WC1N 1EH, UK

name: Harvard TH Chan School of Public Health, Harvard University, Boston, MA 02115, USA

name: University of Massachusetts Medical School, UMass, Worcester, MA 01655, USA

name: PTC Therapeutics Inc., South Plainfield, NJ 07080, USA

name: on behalf of the PTC124-GD-007-DMD Study Group

repository_normalized: University of Melbourne - Minerva Access

repository_institution: University of Massachusetts Medical School - eScholarship@UMMS

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

repository_institution: University College London - UCL Discovery

repositories: University of Melbourne - Minerva Access

location_country:
Italy
United States
Sweden
Germany
France
Israel
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: Hadassah Medical Center, Hebrew University Hospital

location_facility: Imperial College London, Hammersmith Hospital

location_facility: Washington University School of Medicine

location_facility: U.O. Complessa di Neuropsichiatria Infantile

location_facility: Institute For Neuromuscular Research, The Children's Hospital at Westmead

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University Clinic for Children, University of Essen

location_facility: Robert Jones and Agnes Hunt Orthopaedic NHS Trust

location_facility: Children's Hospital of Boston/Harvard Medical School

location_facility: Service de Neuropediatrie, hôpital La Timone

location_facility: Univ of Newcastle, Institute of Human Genetics

title: A Phase 2B Efficacy and Safety Study of PTC124 in Subjects With Nonsense-Mutation-Mediated Duchenne and Becker Muscular Dystrophy

summary: DMD/BMD is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability during childhood and teenage years. A specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of DMD/BMD in approximately 13 percent (%) of boys with the disease. Ataluren is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 2b trial that will evaluate the clinical benefit of ataluren in boys with DMD/BMD due to a nonsense mutation. The main goals of the study are to understand whether ataluren can improve walking, activity, muscle function, and strength and whether the drug can safely be given for a long period of time.


title: A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible Doses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting Intramuscular Injection in Subjects With Schizophrenia

summary: The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate in patients with Schizophrenia.

ReferenceCitation: Alphs L, Bossie CA, Fu DJ, Ma YW, Kern Sliwa J. Onset and persistence of efficacy by symptom domain with long-acting injectable paliperidone palmitate in patients with schizophrenia. Expert Opin Pharmacother. 2014 May;15(7):1029-42. doi: 10.1517/14656566.2014.909409.

family: Alphs

full_name: Larry Alphs

given: Larry

family: Bossie

full_name: Cynthia A Bossie

given: Cynthia A

family: Fu

full_name: Dong-Jing Fu

given: Dong-Jing

family: Ma

full_name: Yi-Wen Ma

given: Yi-Wen

family: Kern Sliwa

full_name: Jennifer Kern Sliwa

given: Jennifer

journal_name: Expert Opinion on Pharmacotherapy

publisher: Informa Healthcare

ReferenceCitation: Fu DJ, Bossie CA, Sliwa JK, Ma YW, Alphs L. Paliperidone palmitate versus oral risperidone and risperidone long-acting injection in patients with recently diagnosed schizophrenia: a tolerability and efficacy comparison. Int Clin Psychopharmacol. 2014 Jan;29(1):45-55. doi: 10.1097/YIC.0000000000000006.

full_name: Cynthia A. Bossie

given: Cynthia A.

family: Sliwa

full_name: Jennifer K. Sliwa

given: Jennifer K.

bso_classification: Social sciences

ReferenceCitation: Fu DJ, Bossie CA, Kern Sliwa J, Ma YW, Alphs L. Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens. Clin Schizophr Relat Psychoses. 2014 Jul;8(2):101-9, 109A. doi: 10.3371/CSRP.FUBO.022213.

given: Jennifer Kern

journal_name: Clinical Schizophrenia & Related Psychoses

publisher: Longdom Group

publisher_dissemination: Longdom Group

publisher_group: Longdom Group

publisher_normalized: Longdom Group

title: Paliperidone Palmitate versus Risperidone Long-Acting Injection in Markedly-to-Severely Ill Schizophrenia Subjects

ReferenceCitation: Pandina G, Lane R, Gopal S, Gassmann-Mayer C, Hough D, Remmerie B, Simpson G. A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jan 15;35(1):218-26. doi: 10.1016/j.pnpbp.2010.11.008. Epub 2010 Nov 16.

journal_name: Progress in Neuro-Psychopharmacology and Biological Psychiatry

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
Austria
India
Germany
France
Bulgaria
Lithuania
Poland
Hungary
Russian Federation
Spain
Estonia
United States
Czech Republic
Ukraine


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Effects of a One-Year Course of Fluticasone Furoate Nasal Spray 110mcg QD on Growth in Pre-Pubescent, Pediatric Subjects With Perennial Allergic Rhinitis

summary: The primary objective of this study is to characterize, as accurately as possible, the estimation of the difference in pre-pubescent growth velocities between subjects treated continuously for one year with FFNS 110mcg QD, the highest dose approved for pediatric use in the US, and placebo nasal spray as determined by stadiometry.

ReferenceCitation: Lee LA, Sterling R, Máspero J, Clements D, Ellsworth A, Pedersen S. Growth velocity reduced with once-daily fluticasone furoate nasal spray in prepubescent children with perennial allergic rhinitis. J Allergy Clin Immunol Pract. 2014 Jul-Aug;2(4):421-7. doi: 10.1016/j.jaip.2014.04.008. Epub 2014 May 21.

family: Lee

full_name: Laurie A. Lee

given: Laurie A.

family: Sterling

full_name: Richard Sterling

given: Richard

family: Máspero

full_name: Jorge Máspero

given: Jorge

family: Clements

full_name: Diane Clements

given: Diane

family: Ellsworth

full_name: Anna Ellsworth

given: Anna

family: Pedersen

full_name: Soren Pedersen

given: Soren

journal_name: The Journal of Allergy and Clinical Immunology: In Practice

title: Growth Velocity Reduced with Once-Daily Fluticasone Furoate Nasal Spray in Prepubescent Children with Perennial Allergic Rhinitis

location_country:
Italy
United States
Chile
Peru
France
Argentina
Canada


lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
France
Germany
United Kingdom
Canada

location_facility: VA Maryland Health Care Dept.of GreenbaumCancerCent(3)

location_facility: Norwalk Hospital Dept of Norwalk Hospital (2)

location_facility: University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital

location_facility: University of Colorado Dept. of Univ. of Colorado

location_facility: Ohio State Comprehensive Cancer Center/James Cancer Hospital SC

title: A Phase Ib/IIa Trial of Panobinostat in Combination With Trastuzumab in Adult Female Patients With HER2 Positive Metastatic Breast Cancer Whose Disease Has Progressed During or Following Therapy With Trastuzumab

summary: The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat plus trastuzumab. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer


title: Randomized, Double Blind, Placebo Controlled, Phase 2 Study Evaluating the Efficacy & Safety of RP101 or Placebo in Combination With Gemcitabine Administered as First-Line Treatment to Subjects With Unresectable, Locally Advanced, or Metastatic Pancreatic Adenocarcinoma

summary: This will be a Phase II, multicenter, randomized, double blind, placebo controlled, study of six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic pancreatic cancer. The study will be conducted at approximately 55 sites in the North American, Europe, and South America. Approximately 153 subjects will be enrolled in a randomization (ratio 2:1).

primary_purpose: Health Services Research

enrollment_type: Anticipated

ReferenceCitation: Heinrich JC, Tuukkanen A, Schroeder M, Fahrig T, Fahrig R. RP101 (brivudine) binds to heat shock protein HSP27 (HSPB1) and enhances survival in animals and pancreatic cancer patients. J Cancer Res Clin Oncol. 2011 Sep;137(9):1349-61. doi: 10.1007/s00432-011-1005-1. Epub 2011 Jul 22.

family: Heinrich

full_name: Jörg-Christian Heinrich

given: Jörg-Christian

family: Tuukkanen

full_name: Anne Tuukkanen

given: Anne

family: Schroeder

full_name: Michael Schroeder

given: Michael

family: Fahrig

full_name: Torsten Fahrig

given: Torsten

full_name: Rudolf Fahrig

given: Rudolf

journal_name: Journal of Cancer Research and Clinical Oncology

lead_sponsor: SciClone Pharmaceuticals

location_country:
Brazil
Chile
Peru
Netherlands
Germany
France
Poland
Romania
Hungary
Argentina
Spain
United States
United Kingdom

location_facility: Universitätsklinikum Dresden, Med. Klinik I

location_facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum, Onkológiai Tanszék

location_facility: Fovárosi Önkormányzat Egyesített Szent István és Szent László Kórház-Rendelointézet

location_facility: Klinikum rechts der Isar, Technische Universität München

location_facility: University of Arizona Medical Center, Arizona Cancer Center

location_facility: Tower Research Foundation at Tower Oncology

location_facility: I Katedra Chirurgii Ogólnej i Klinika Chirurgii Gastroenterologicznej

location_facility: Hospital Zonal General de Agudos San Roque

location_facility: Hospital de Clínicas de Porto Alegre, Serviço de Oncologia

location_facility: Medical College of Wisconsin, Froedtert Multi-Disciplinary Cancer Center

location_facility: Centre Eugene Marquis, Service d'Oncologie Medicale

location_facility: Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro

location_facility: Hospital 12 de Octubre, Oncology Service, Hospital Materno Infantil

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Klinikum Region Hannover GmbH, Krankenhause Siloah

location_facility: Institutul Oncologic 'Prof. Dr. A. Trestioreanu'

location_facility: Hospital Universitario Arnau de Vilanova, Servicio de Oncologia

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Petz Aladár Megyei Oktató Kórház Orvostovábbképzo Egyetem Oktató-Továbbképzo Kórháza, Onkoradiológia

location_facility: University of California at San Francisco

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewódzki

location_facility: Wojewódzki Szpital Specjalistyczny im Kopernika w Lodzi

location_facility: Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust

location_facility: Integrated Community Oncology Network, LLC

location_facility: Fovárosi Önkormányzat Uzsoki utcai Kórháza


title: Study of Once-Daily Abacavir/Lamivudine Versus Tenofovir/Emtricitabine, Administered With Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects

acronym: ASSERT

summary:
Recently, the fixed-dose combinations (FDC) KIVEXA™ (abacavir/lamivudine) and TRUVADA (tenofovir disoproxil fumarate/emtricitabine) have facilitated the usage of once-daily regimens. However data from head-to-head randomized trials comparing these two FDCs as part of an initial regimen are not available at present. The long-term toxicity profiles of these regimens are of particular importance, as treatment of HIV is currently life-long and therefore, minimizing long-term toxicity and maximizing adherence and duration of regimen maintenance are critical therapy objectives.

The primary endpoint is estimated glomerular filtration rate (GFR), as measured by the modified diet in renal disease (MDRD) equation, a validated estimate of renal function.

ReferenceCitation: Post FA, Moyle GJ, Stellbrink HJ, Domingo P, Podzamczer D, Fisher M, Norden AG, Cavassini M, Rieger A, Khuong-Josses MA, Branco T, Pearce HC, Givens N, Vavro C, Lim ML. Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study. J Acquir Immune Defic Syndr. 2010 Sep;55(1):49-57. doi: 10.1097/QAI.0b013e3181dd911e.

location_country:
Italy
Austria
Switzerland
Netherlands
Spain
United Kingdom
France
Ireland
Belgium
Portugal
Denmark
Germany
Latvia


location_country:
Italy
United States
United Kingdom
France
Spain
Germany
Czech Republic

location_facility:
Site Reference ID/Investigator# 6617
Site Reference ID/Investigator# 5553
Site Reference ID/Investigator# 5557
Site Reference ID/Investigator# 7133
Site Reference ID/Investigator# 6238
Site Reference ID/Investigator# 6607
Site Reference ID/Investigator# 7229
Site Reference ID/Investigator# 6616
Site Reference ID/Investigator# 5552
Site Reference ID/Investigator# 7714
Site Reference ID/Investigator# 9363
Site Reference ID/Investigator# 6609
Site Reference ID/Investigator# 6234
Site Reference ID/Investigator# 6575
Site Reference ID/Investigator# 8179
Site Reference ID/Investigator# 6618
Site Reference ID/Investigator# 7911
Site Reference ID/Investigator# 6358
Site Reference ID/Investigator# 5555
Site Reference ID/Investigator# 5558
Site Reference ID/Investigator# 11202
Site Reference ID/Investigator# 6564
Site Reference ID/Investigator# 5549
Site Reference ID/Investigator# 6475
Site Reference ID/Investigator# 11201
Site Reference ID/Investigator# 6614
Site Reference ID/Investigator# 6356
Site Reference ID/Investigator# 5554
Site Reference ID/Investigator# 6615

title: A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-894 Versus Placebo in Subjects With Diabetic Neuropathic Pain

summary: The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose of an investigational product in subjects with diabetic neuropathy


title: A Phase III, Multicentre, Open Label, Flexible Dose, Long Term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

summary: This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks

lead_sponsor: Mitsubishi Tanabe Pharma Corporation

location_country: Macedonia, The Former Yugoslav Republic of


location_country:
United States
Mexico
France
Belgium
Turkey
Germany

title: Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (4 - 16 Years Old) With Epilepsy.

summary: Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 4 to 16 years.


title: A Phase IIB, Multi-Dose, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis

summary: The purpose of this study is to determine an optimal abatacept dosing regimen for the treatment of active arthritis due to psoriatic arthritis in patients who have had a prior inadequate response to disease-modifying antirheumatic drugs, including methotrexate and tumor necrosis factor alpha-blockade compounds.

ReferenceCitation: Mease P, Genovese MC, Gladstein G, Kivitz AJ, Ritchlin C, Tak PP, Wollenhaupt J, Bahary O, Becker JC, Kelly S, Sigal L, Teng J, Gladman D. Abatacept in the treatment of patients with psoriatic arthritis: results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial. Arthritis Rheum. 2011 Apr;63(4):939-48. doi: 10.1002/art.30176.

family: Mease

full_name: Philip Mease

given: Philip

family: Genovese

full_name: Mark C. Genovese

given: Mark C.

family: Gladstein

full_name: Geoffrey Gladstein

given: Geoffrey

family: Kivitz

full_name: Alan J. Kivitz

given: Alan J.

family: Ritchlin

full_name: Christopher Ritchlin

given: Christopher

family: Tak

full_name: Paul P. Tak

given: Paul P.

family: Wollenhaupt

full_name: Jürgen Wollenhaupt

given: Jürgen

family: Bahary

full_name: Orna Bahary

given: Orna

family: Becker

full_name: Jean-Claude Becker

given: Jean-Claude

family: Kelly

full_name: Sheila Kelly

given: Sheila

family: Sigal

full_name: Leonard Sigal

given: Leonard

family: Teng

full_name: Julie Teng

given: Julie

family: Gladman

full_name: Dafna Gladman

given: Dafna

journal_name: Arthritis & Rheumatism

title: Abatacept in the treatment of patients with psoriatic arthritis: Results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial

location_country:
Italy
United States
South Africa
Netherlands
Germany
France
Norway
Belgium
Argentina
Australia
Spain
Canada

location_facility: Rheumatology Associates Of North Alabama

location_facility: Arthritis Clinic & Carolina Bone & Joint, Pa