ReferenceCitation: Landewé R, Braun J, Deodhar A, Dougados M, Maksymowych WP, Mease PJ, Reveille JD, Rudwaleit M, van der Heijde D, Stach C, Hoepken B, Fichtner A, Coteur G, de Longueville M, Sieper J. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study. Ann Rheum Dis. 2014 Jan;73(1):39-47. doi: 10.1136/annrheumdis-2013-204231. Epub 2013 Sep 6.

family: Landewé

full_name: R Landewé

given: R

family: Braun

full_name: J Braun

given: J

family: Deodhar

full_name: A Deodhar

given: A

family: Dougados

full_name: M Dougados

given: M

family: Maksymowych

full_name: W P Maksymowych

given: W P

family: Mease

full_name: P J Mease

given: P J

family: Reveille

full_name: J D Reveille

given: J D

family: Rudwaleit

full_name: M Rudwaleit

family: van der Heijde

full_name: D van der Heijde

given: D

family: Stach

full_name: C Stach

given: C

family: Hoepken

full_name: B Hoepken

given: B

family: Fichtner

full_name: A Fichtner

family: Coteur

full_name: G Coteur

given: G

family: de Longueville

full_name: M de Longueville

family: Sieper

full_name: J Sieper

journal_name: Annals of the Rheumatic Diseases

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Landewé R, Nurminen T, Davies O, Baeten D. A single determination of C-reactive protein does not suffice to declare a patient with a diagnosis of axial spondyloarthritis 'CRP-negative'. Arthritis Res Ther. 2018 Sep 14;20(1):209. doi: 10.1186/s13075-018-1707-8.

full_name: Robert Landewé

given: Robert

family: Nurminen

full_name: Tommi Nurminen

given: Tommi

family: Davies

full_name: Owen Davies

title: A single determination of C-reactive protein does not suffice to declare a patient with a diagnosis of axial spondyloarthritis ‘CRP-negative’

ReferenceCitation: van der Heijde D, Dougados M, Landewé R, Sieper J, Maksymowych WP, Rudwaleit M, Van den Bosch F, Braun J, Mease PJ, Kivitz AJ, Walsh J, Davies O, Bauer L, Hoepken B, Peterson L, Deodhar A. Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpA. Rheumatology (Oxford). 2017 Sep 1;56(9):1498-1509. doi: 10.1093/rheumatology/kex174.

name: Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands

name: Department of Rheumatology, Cochin Hospital, Paris, France

name: Clinical Immunology and Rheumatology, Academic Medical Center, Amsterdam

name: Department of Rheumatology, Zuyderland Medical Center, Heerlen, The Netherlands

name: Rheumatology Department, Charité – University Medicine, Berlin, Germany

name: Department of Medicine, University of Alberta, Edmonton, Alberta, Canada

name: Department of Internal Medicine and Rheumatology, Klinikum Bielefeld, Bielefeld, Germany

name: Department of Internal Medicine, Ghent University Hospital, Ghent, Belgium

name: Rheumazentrum Ruhrgebiet, Herne, Germany

name: Swedish Medical Center, University of Washington, Seattle, WA

name: Altoona Center for Clinical Research, Duncansville, PA

name: Division of Rheumatology, University of Utah School of Medicine, Salt Lake City, UT, USA

name: Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, USA

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

repositories_institution: Ghent University - Ghent University Academic Bibliography

ReferenceCitation: van der Heijde D, Deodhar A, Fleischmann R, Mease PJ, Rudwaleit M, Nurminen T, Davies O. Early Disease Activity or Clinical Response as Predictors of Long-Term Outcomes With Certolizumab Pegol in Axial Spondyloarthritis or Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1030-1039. doi: 10.1002/acr.23092. Epub 2017 Jun 2.

name: Leiden University Medical Center; Leiden The Netherlands

name: Oregon Health and Science University; Portland

name: University of Texas SW Medical Center; Dallas

name: Swedish Medical Center and University of Washington; Seattle

name: Klinikum Bielefeld and Charité Berlin, Berlin, Germany, and Ghent University; Ghent Belgium

repositories_institution:
Leiden University - Leiden Repository
PubMed Central - Europe PMC

ReferenceCitation: Rudwaleit M, Rosenbaum JT, Landewé R, Marzo-Ortega H, Sieper J, van der Heijde D, Davies O, Bartz H, Hoepken B, Nurminen T, Deodhar A. Observed Incidence of Uveitis Following Certolizumab Pegol Treatment in Patients With Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 2016 Jun;68(6):838-44. doi: 10.1002/acr.22848.

name: Devers Eye Institute, Legacy Health System, Portland, Oregon, and Oregon Health & Science University; Portland

name: Academic Medical Center, Amsterdam and Atrium Medical Center; Heerlen the Netherlands

name: Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; Leeds UK

name: University Hospital Charité; Berlin Germany

name: Leiden University Medical Centre; Leiden the Netherlands

ReferenceCitation: Sieper J, Kivitz A, van Tubergen A, Deodhar A, Coteur G, Woltering F, Landewé R. Impact of Certolizumab Pegol on Patient-Reported Outcomes in Patients With Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 2015 Oct;67(10):1475-80. doi: 10.1002/acr.22594.

name: University Hospital CharitéBerlin Germany

name: Altoona Center for Clinical ResearchDuncansville Pennsylvania

name: Maastricht University Medical CenterMaastricht The Netherlands

name: Oregon Health and Science University Portland

name: Amsterdam and Atrium Medical CenterHeerlen The Netherlands

title: Impact of Certolizumab Pegol on Patient‐Reported Outcomes in Patients With Axial Spondyloarthritis

location_country:
Italy
United States
Brazil
Mexico
Netherlands
Germany
France
Czechia
Poland
Hungary
Belgium
Argentina
Spain
Canada
United Kingdom

title: Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

summary: The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA).


design_allocation: Randomized

intervention_type: Drug

status: Completed

study_type: Interventional

lead_sponsor: Janssen-Cilag International NV

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Jordan
Greece
Romania
Belgium
Russian Federation
Czech Republic
Taiwan
Ukraine
Croatia
France
Lithuania
Poland
Slovakia
Korea, Republic of
Turkey
South Africa
Bulgaria
Hungary
Germany
United Kingdom
Austria
Israel
Egypt
Spain
Estonia

acronym: PROSIPAL

study_completion_date_type: Actual

type: Other Identifier

type: EudraCT Number

source: euctr

title: A 24-month, Prospective, Randomized, Active-Controlled, Open-Label, Rater-Blinded, Multicenter, International Study of the Prevention of Relapse Comparing Long-Acting Injectable Paliperidone Palmitate to Treatment as Usual With Oral Antipsychotic Monotherapy in Adults With Schizophrenia

summary: The purpose of this study is to assess the efficacy (how well the drug works; primarily through the time to relapse) of long-acting injectable paliperidone palmitate compared to treatment as usual with orally administered antipsychotics in monotherapy over 24 months in the treatment of recently diagnosed (1-5 years since diagnosis) schizophrenia.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Ustekinumab, a Fully Human Anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNFalpha Agent(s)

summary: The purpose of this study is to evaluate the efficacy (improvement of signs and symptoms) and safety of ustekinumab in patients with psoriatic arthritis.

ReferenceType: derived

ReferenceCitation: Helliwell PS, Gladman DD, Chakravarty SD, Kafka S, Karyekar CS, You Y, Campbell K, Sweet K, Kavanaugh A, Gensler LS. Effects of ustekinumab on spondylitis-associated endpoints in TNFi-naïve active psoriatic arthritis patients with physician-reported spondylitis: pooled results from two phase 3, randomised, controlled trials. RMD Open. 2020 Feb;6(1). pii: e001149. doi: 10.1136/rmdopen-2019-001149.

family: Helliwell

full_name: Philip S Helliwell

given: Philip S

sequence: first

family: Gladman

full_name: Dafna D Gladman

given: Dafna D

sequence: additional

family: Chakravarty

full_name: Soumya D Chakravarty

given: Soumya D

family: Kafka

full_name: Shelly Kafka

given: Shelly

family: Karyekar

full_name: Chetan S Karyekar

given: Chetan S

family: You

full_name: Yin You

given: Yin

family: Campbell

full_name: Kim Campbell

given: Kim

family: Sweet

full_name: Kristen Sweet

given: Kristen

family: Kavanaugh

full_name: Arthur Kavanaugh

given: Arthur

family: Gensler

full_name: Lianne S Gensler

given: Lianne S

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: RMD Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

ReferenceCitation: Siebert S, Sweet K, Dasgupta B, Campbell K, McInnes IB, Loza MJ. Responsiveness of Serum C-Reactive Protein, Interleukin-17A, and Interleukin-17F Levels to Ustekinumab in Psoriatic Arthritis: Lessons From Two Phase III, Multicenter, Double-Blind, Placebo-Controlled Trials. Arthritis Rheumatol. 2019 Oct;71(10):1660-1669. doi: 10.1002/art.40921. Epub 2019 Sep 3.

family: Siebert

full_name: Stefan Siebert

given: Stefan

name: Janssen Research and Development LLC Spring House Pennsylvania

family: Dasgupta

full_name: Bidisha Dasgupta

given: Bidisha

family: McInnes

full_name: Iain B. McInnes

given: Iain B.

family: Loza

repository_institution: The University of Glasgow - Enlighten: Publications

title: Responsiveness of Serum C‐Reactive Protein, Interleukin‐17A, and Interleukin‐17F Levels to Ustekinumab in Psoriatic Arthritis: Lessons From Two Phase III, Multicenter, Double‐Blind, Placebo‐Controlled Trials

ReferenceCitation: Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum in: Drug Saf. 2019 Apr 22;:.

repository_institution: University of Birmingham - University of Birmingham Research Portal

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

repository_institution: California Digital Library - eScholarship

title: Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs

ReferenceCitation: Rahman P, Puig L, Gottlieb AB, Kavanaugh A, McInnes IB, Ritchlin C, Li S, Wang Y, Song M, Mendelsohn A, Han C; PSUMMIT 1 and 2 Study Groups. Ustekinumab Treatment and Improvement of Physical Function and Health-Related Quality of Life in Patients With Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1812-1822. doi: 10.1002/acr.23000. Epub 2016 Oct 21.

name: Memorial University; Newfoundland Canada

name: Hospital de la Santa Creu i Sant Pau, Universitat Autònoa de Barcelona; Barcelona Spain

name: Tufts University School of Medicine; Boston Massachusetts

name: University of Rochester; Rochester New York

name: Janssen Research & Development, LLC; Spring House Pennsylvania

name: Janssen Global Services, LLC; Malvern Pennsylvania

name: on behalf of the PSUMMIT 1 and 2 Study Groups

ReferenceCitation: Kavanaugh A, Puig L, Gottlieb AB, Ritchlin C, You Y, Li S, Song M, Randazzo B, Rahman P, McInnes IB. Efficacy and safety of ustekinumab in psoriatic arthritis patients with peripheral arthritis and physician-reported spondylitis: post-hoc analyses from two phase III, multicentre, double-blind, placebo-controlled studies (PSUMMIT-1/PSUMMIT-2). Ann Rheum Dis. 2016 Nov;75(11):1984-1988. doi: 10.1136/annrheumdis-2015-209068. Epub 2016 Apr 20.

location_country:
Austria
Sweden
Germany
France
Poland
Hungary
Russian Federation
United States
United Kingdom
Canada


ReferenceType: result

ReferenceCitation: Ghio S, Bonderman D, Felix SB, Ghofrani HA, Michelakis ED, Mitrovic V, Oudiz RJ, Frey R, Roessig L, Semigran MJ. Left ventricular systolic dysfunction associated with pulmonary hypertension riociguat trial (LEPHT): rationale and design. Eur J Heart Fail. 2012 Aug;14(8):946-53. doi: 10.1093/eurjhf/hfs071. Epub 2012 Jun 20.

name: Department of Cardiology, Fondazione IRCCS Policlinico San Matteo; University Hospital; Pavia Italy

family: Ghio

full_name: Stefano Ghio

given: Stefano

name: Department of Internal Medicine II; Medical University of Vienna; Austria

family: Bonderman

full_name: Diana Bonderman

given: Diana

name: Department of Cardiology and Internal Medicine B; University Medicine, Ernst-Moritz-Arndt-University of Greifswald; Germany

family: Felix

full_name: Stephan B. Felix

given: Stephan B.

name: University Hospital Giessen and Marburg GmbH, Justus-Liebig University Giessen; Germany

family: Ghofrani

full_name: Hossein A. Ghofrani

given: Hossein A.

name: Department of Medicine; University of Alberta; Edmonton Canada

family: Michelakis

full_name: Evangelos D. Michelakis

given: Evangelos D.

name: Kerckhoff-Klinik Forschungsgesellschaft mbH; Bad Nauheim Germany

family: Mitrovic

full_name: Veselin Mitrovic

given: Veselin

name: Harbor-UCLA Medical Center; Torrance CA USA

family: Oudiz

full_name: Ronald J. Oudiz

given: Ronald J.

name: Clinical Pharmacology; Bayer Pharma AG Berlin; Germany

family: Frey

full_name: Reiner Frey

given: Reiner

name: Global Clinical Development; Bayer Pharma AG Berlin; Germany

family: Roessig

full_name: Lothar Roessig

given: Lothar

name: Cardiology Division, Department of Medicine; Massachusetts General Hospital and Harvard Medical School; Boston MA USA

family: Semigran

full_name: Marc J. Semigran

given: Marc J.

journal_name: European Journal of Heart Failure

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Bonderman D, Ghio S, Felix SB, Ghofrani HA, Michelakis E, Mitrovic V, Oudiz RJ, Boateng F, Scalise AV, Roessig L, Semigran MJ; Left Ventricular Systolic Dysfunction Associated With Pulmonary Hypertension Riociguat Trial (LEPHT) Study Group. Riociguat for patients with pulmonary hypertension caused by systolic left ventricular dysfunction: a phase IIb double-blind, randomized, placebo-controlled, dose-ranging hemodynamic study. Circulation. 2013 Jul 30;128(5):502-11. doi: 10.1161/CIRCULATIONAHA.113.001458. Epub 2013 Jun 17.

name: From the Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria (D.B.); Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, University Hospital, Pavia, Italy (S.G.); Department of Cardiology and Internal Medicine B, University Medicine Greifswald, and DZHK (German Centre for Cardiovascular Research), Greifswald, Germany (S.B.F.); University of Giessen and Marburg Lung Center, and German Center of Lung Research, Giessen, Germany (H.-A.G.); Department of...

full_name: Hossein-Ardeschir Ghofrani

given: Hossein-Ardeschir

full_name: Evangelos Michelakis

given: Evangelos

family: Boateng

full_name: Francis Boateng

given: Francis

family: Scalise

full_name: Andrea-Viviana Scalise

given: Andrea-Viviana

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Riociguat for Patients With Pulmonary Hypertension Caused by Systolic Left Ventricular Dysfunction

ipd_sharing_description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Italy
Austria
United States
Switzerland
Netherlands
Spain
Germany
France
Czechia
Japan
Poland
Singapore
Australia
Belgium
China
Denmark
Canada
United Kingdom

title: Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-center Study to Evaluate the Hemodynamic Effects of Riociguat (BAY 63-2521) as Well as Safety and Kinetics in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

summary: The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction


title: Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer

summary: The purpose of this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo

ReferenceCitation: de Liaño AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

family: de Liaño

full_name: A G de Liaño

given: A G

family: Reig

full_name: O Reig

given: O

family: Mellado

full_name: B Mellado

given: B

family: Martin

full_name: C Martin

given: C

family: Rull

full_name: E U Rull

given: E U

family: Maroto

full_name: J P Maroto

given: J P

journal_name: British Journal of Cancer

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Dayyani F, Gallick GE, Logothetis CJ, Corn PG. Novel therapies for metastatic castrate-resistant prostate cancer. J Natl Cancer Inst. 2011 Nov 16;103(22):1665-75. doi: 10.1093/jnci/djr362. Epub 2011 Sep 13. Review.

family: Dayyani

full_name: F. Dayyani

given: F.

family: Gallick

full_name: G. E. Gallick

given: G. E.

family: Logothetis

full_name: C. J. Logothetis

given: C. J.

family: Corn

full_name: P. G. Corn

given: P. G.

journal_name: JNCI Journal of the National Cancer Institute

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

title: Novel Therapies for Metastatic Castrate-Resistant Prostate Cancer

location_country:
Greece
Romania
Australia
Denmark
Czech Republic
France
Poland
Norway
Argentina
Canada
Colombia
Chile
Sweden
Netherlands
Hungary
Puerto Rico
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Spain
Turkey

location_facility: North Shore Hematology/Oncology Associates, P.C.

location_facility: Scott & White Memorial Hospital And Clinic

location_facility: Hematology Oncology Associates Of The Treasure Coast

location_facility: St. Luke'S Hospital & Health Network Laboratory

location_facility: Lynn Cancer Institute Center For Hematology-Oncology

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: Cancer Care Specialists Of Central Illinois

location_facility: Southern California Permanente Medical Group

location_facility: Providence Regional Medical Center Everett

location_facility: Kansas City Veterans Affairs Medical Center


ReferenceCitation: Maltais F, Kirsten AM, Hamilton A, De Sousa D, Voß F, Decramer M. Evaluation of the effects of olodaterol on exercise endurance in patients with chronic obstructive pulmonary disease: results from two 6-week crossover studies. Respir Res. 2016 Jul 6;17(1):77. doi: 10.1186/s12931-016-0389-5.

family: Maltais

full_name: François Maltais

given: François

family: Kirsten

full_name: Anne-Marie Kirsten

given: Anne-Marie

family: Hamilton

full_name: Alan Hamilton

given: Alan

family: De Sousa

full_name: Dorothy De Sousa

given: Dorothy

family: Voß

full_name: Florian Voß

given: Florian

family: Decramer

full_name: Marc Decramer

given: Marc

journal_name: Respiratory Research

license: cc-by

license_normalized: cc-by

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

lead_sponsor: Boehringer Ingelheim

location_country: Austria Germany France Australia Canada

location_facility: 1222.37.1073 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.6172 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.33006 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4972 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4971 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.1074 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.33003 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.33004 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4371 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4970 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.33005 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.6173 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.6171 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.33001 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4973 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.6174 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4372 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.1072 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.33002 Boehringer Ingelheim Investigational Site

title: Randomised, Double-blind, Placebo-controlled, 3-way Cross-over Study to Determine the Effect of Treatment of Orally Inhaled BI 1744 CL (5 µg [2 Actuations of 2.5 µg] and 10 µg [2 Actuations of 5 µg]) Delivered by the Respimat® Inhaler on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease

summary: To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease


type: Registry Identifier

title: A Phase 2a/2b Study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotypes 1 and 4 Chronic Hepatitis C Infection

summary: The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).

ReferenceCitation: Bronowicki JP, Ratziu V, Gadano A, Thuluvath PJ, Bessone F, Martorell CT, Pol S, Terg R, Younes Z, He B, Eley T, Cohen D, Yu F, Hernandez D, McPhee F, Mendez P, Hughes E. Randomized trial of asunaprevir plus peginterferon alfa and ribavirin for previously untreated genotype 1 or 4 chronic hepatitis C. J Hepatol. 2014 Dec;61(6):1220-7. doi: 10.1016/j.jhep.2014.07.011. Epub 2014 Jul 16.

family: Bronowicki

full_name: Jean-Pierre Bronowicki

given: Jean-Pierre

family: Ratziu

full_name: Vlad Ratziu

given: Vlad

family: Gadano

full_name: Adrian Gadano

given: Adrian

family: Thuluvath

full_name: Paul J. Thuluvath

given: Paul J.

family: Bessone

full_name: Fernando Bessone

given: Fernando

family: Martorell

full_name: Claudia T. Martorell

given: Claudia T.

family: Pol

full_name: Stanislas Pol

given: Stanislas

family: Terg

full_name: Ruben Terg

given: Ruben

family: Younes

full_name: Ziad Younes

given: Ziad

family: He

full_name: Bing He

given: Bing

family: Eley

full_name: Timothy Eley

given: Timothy

family: Cohen

full_name: David Cohen

given: David

family: Yu

full_name: Fei Yu

given: Fei

family: Hernandez

full_name: Dennis Hernandez

given: Dennis

family: McPhee

full_name: Fiona McPhee

given: Fiona

family: Mendez

full_name: Patricia Mendez

given: Patricia

family: Hughes

full_name: Eric Hughes

given: Eric

journal_name: Journal of Hepatology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
France
Ireland
Argentina
Spain
Germany
United Kingdom

location_facility: Hospital Of The University Of Pennsylvania

location_facility: Alabama Liver & Digestive Specialists (Alds)

location_facility: University Of North Carolina, Chapel Hill


ReferenceCitation: Santini V, Almeida A, Giagounidis A, Gröpper S, Jonasova A, Vey N, Mufti GJ, Buckstein R, Mittelman M, Platzbecker U, Shpilberg O, Ram R, Del Cañizo C, Gattermann N, Ozawa K, Risueño A, MacBeth KJ, Zhong J, Séguy F, Hoenekopp A, Beach CL, Fenaux P. Randomized Phase III Study of Lenalidomide Versus Placebo in RBC Transfusion-Dependent Patients With Lower-Risk Non-del(5q) Myelodysplastic Syndromes and Ineligible for or Refractory to Erythropoiesis-Stimulating Agents. J Clin Oncol. 2016 Sep 1;34(25):2988-96. doi: 10.1200/JCO.2015.66.0118. Epub 2016 Jun 27.

name: Valeria Santini, University of Florence, Florence, Italy; Antonio Almeida, Instituto Português de Oncologia de Lisboa Francisco Gentil, Lisbon, Portugal; Aristoteles Giagounidis and Stefanie Gröpper, Marien Hospital Düsseldorf; Norbert Gattermann, Heinrich-Heine-Universität, Düsseldorf; Uwe Platzbecker, Technical University Dresden, Dresden, Germany; Anna Jonasova, Charles University General Hospital, Prague, Czech Republic; Norbert Vey, Centre Régional de Lutte Contre le Cancer, Marseille; Pierre Fenaux...

family: Santini

full_name: Valeria Santini

given: Valeria

family: Almeida

full_name: Antonio Almeida

given: Antonio

family: Giagounidis

full_name: Aristoteles Giagounidis

given: Aristoteles

family: Gröpper

full_name: Stefanie Gröpper

given: Stefanie

family: Jonasova

full_name: Anna Jonasova

given: Anna

family: Vey

full_name: Norbert Vey

given: Norbert

family: Mufti

full_name: Ghulam J. Mufti

given: Ghulam J.

family: Buckstein

full_name: Rena Buckstein

given: Rena

family: Mittelman

full_name: Moshe Mittelman

given: Moshe

family: Platzbecker

full_name: Uwe Platzbecker

given: Uwe

family: Shpilberg

full_name: Ofer Shpilberg

given: Ofer

family: Ram

full_name: Ron Ram

given: Ron

family: del Cañizo

full_name: Consuelo del Cañizo

given: Consuelo

family: Gattermann

full_name: Norbert Gattermann

family: Ozawa

full_name: Keiya Ozawa

given: Keiya

family: Risueño

full_name: Alberto Risueño

given: Alberto

family: MacBeth

full_name: Kyle J. MacBeth

given: Kyle J.

family: Zhong

full_name: Jianhua Zhong

given: Jianhua

family: Séguy

full_name: Francis Séguy

given: Francis

family: Hoenekopp

full_name: Albert Hoenekopp

given: Albert

family: Beach

full_name: C.L. Beach

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Santini V, Almeida A, Giagounidis A, Skikne B, Beach CL, Weaver J, Tu N, Fenaux P. Achievement of red blood cell transfusion independence in red blood cell transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes correlates with serum erythropoietin levels. Leuk Lymphoma. 2020 Jun;61(6):1475-1483. doi: 10.1080/10428194.2020.1719088. Epub 2020 Feb 17.

name: MDS Unit, Hematology, AOU Careggi, University of Florence, Florence, Italy;

name: Marien Hospital Düsseldorf, Düsseldorf, Germany;

name: Formerly Celgene Corporation, Summit, NJ, USA;

repository_institution: University of Florence - Florence Research

ReferenceCitation: Almeida A, Fenaux P, Garcia-Manero G, Goldberg SL, Gröpper S, Jonasova A, Vey N, Castaneda C, Zhong J, Beach CL, Santini V. Safety profile of lenalidomide in patients with lower-risk myelodysplastic syndromes without del(5q): results of a phase 3 trial. Leuk Lymphoma. 2018 Sep;59(9):2135-2143. doi: 10.1080/10428194.2017.1421758. Epub 2018 Jan 11.

name: Departamento de Hematologia, Instituto Português de Oncologia de Lisboa Francisco Gentil, Lisbon, Portugal;

name: Service d’Hématologie Séniors, Hôpital Saint-Louis, Université Paris 7, Paris, France;

name: MD Anderson Cancer Center, Houston, TX, USA;

name: John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA;

name: First Faculty of Medicine, Charles University General Hospital, Prague, Czech Republic;

name: Institut Paoli-Calmettes, Centre Régional de Lutte Contre le Cancer, Marseilles, France;

name: Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy

location_country:
Italy
Austria
United States
Spain
Germany
France
Czechia
Japan
Israel
Poland
Australia
Belgium
Portugal
Turkey
Canada
United Kingdom

location_facility: Katedra i Klinika Hematologii i Transplantacji Szpiku - SLASKIEGO UNIWERSYTETU MEDYCZNEGO

location_facility: Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center

location_facility: Center Hospitalier Universitaire Ambroise Pare

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Azienda Ospedaliero-Universitaria di Cagliari

location_facility: Policlinico Agostino Gemelli - Istituto di Ematologia

location_facility: McGill University, Dept. Oncology Clinical Research Program

location_facility: Princess Margaret Hospital and University of Toronto

location_facility: Azienda Policlinico Umberto I, Universita La Sapienzadi Roma

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Az. Osp. SS.Antonio e Biagio - SC Ematologia

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Universitatsklinik fur Innere Medizin Salzburg

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: P.O. Ospedale Roberto Binaghi (UNI CA/ASL 8)

location_facility: Groupe hospitalier Cochin Saint-Vincent de Paul

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture

location_facility: CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang

location_facility: BAG Freiberg-Richter, Jacobash, Illmer, Wolf

location_facility: Royal Adelaide Hospital Institute of Medical and Veterinary Science

location_facility: Barts Cancer Institute, Queen Mary University of London, Charterhouse Square

location_facility: Krankenhaus der Elisabethinen Linz, I Interne Abteilung

location_facility: Instytut Hematologii i Transfuzjologii, Klinika Hematologii

location_facility: Instituto Portugues de Oncologia de Lisboa

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: Klinikum Mannheim der Universitat Heidelberg

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Compare The Efficacy And Safety of Lenalidomide (Revlimid®) Versus Placebo In Subjects With Transufsion-Dependent Anemia Due to IPSS Low Or Imtermidate-1 Risk Myelodysplastic Syndromes Without Deletion 5Q(31) And Unresponsive Or Refractory To Erthropoiesis-Stimulating Agents

summary: The purpose of this study is to investigate whether lenalidomide would reduce the number of red blood cell transfusions (RBC) needed in anemic (RBC transfusion-dependent) participants with low or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study also investigated the safety of lenalidomide use in these participants. Two-thirds of the participants received oral lenalidomide and one-third of the participants received oral placebo.


title: A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect on Unassisted Erectile Function of the Early Use of Tadalafil 5 mg Once a Day and Tadalafil 20 mg On Demand Treatment for 9 Months in Subjects Undergoing Bilateral Nerve-Sparing Radical Prostatectomy

acronym: REACTT

summary: The study will include patients with localized prostate cancer who experience erectile dysfunction following bilateral nerve-sparing radical prostatectomy. Patients will be randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on demand (prior to anticipated sexual activity), and placebo. Patients will stay on therapy for 9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for recovery of unassisted erectile function (without medication). An open-label extension for three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day. Further objectives are to evaluate the treatment satisfaction of the respective therapies.

ReferenceCitation: Montorsi F, Oelke M, Henneges C, Brock G, Salonia A, d'Anzeo G, Rossi A, Mulhall JP, Büttner H. Exploratory Decision-Tree Modeling of Data from the Randomized REACTT Trial of Tadalafil Versus Placebo to Predict Recovery of Erectile Function After Bilateral Nerve-Sparing Radical Prostatectomy. Eur Urol. 2016 Sep;70(3):529-37. doi: 10.1016/j.eururo.2016.02.036. Epub 2016 Mar 3.

family: Montorsi

full_name: Francesco Montorsi

given: Francesco

family: Oelke

full_name: Matthias Oelke

given: Matthias

family: Henneges

full_name: Carsten Henneges

given: Carsten

family: Brock

full_name: Gerald Brock

given: Gerald

family: Salonia

full_name: Andrea Salonia

given: Andrea

family: d’Anzeo

full_name: Gianluca d’Anzeo

given: Gianluca

family: Rossi

full_name: Andrea Rossi

family: Mulhall

full_name: John P. Mulhall

given: John P.

family: Büttner

full_name: Hartwig Büttner

given: Hartwig

journal_name: European Urology

oa_host_type: repository

version: acceptedVersion

ReferenceCitation: Patel HR, Ilo D, Shah N, Cuzin B, Chadwick D, Andrianne R, Henneges C, Barry J, Hell-Momeni K, Branicka J, Büttner H. Effects of tadalafil treatment after bilateral nerve-sparing radical prostatectomy: quality of life, psychosocial outcomes, and treatment satisfaction results from a randomized, placebo-controlled phase IV study. BMC Urol. 2015 Apr 12;15:31. doi: 10.1186/s12894-015-0022-9.

family: Patel

full_name: Hitendra R Patel

given: Hitendra R

family: Ilo

full_name: Dapo Ilo

given: Dapo

family: Shah

full_name: Nimish Shah

given: Nimish

family: Cuzin

full_name: Béatrice Cuzin

given: Béatrice

family: Chadwick

full_name: David Chadwick

given: David

family: Andrianne

full_name: Robert Andrianne

given: Robert

family: Barry

full_name: Jane Barry

given: Jane

family: Hell-Momeni

ReferenceCitation: Montorsi F, Brock G, Stolzenburg JU, Mulhall J, Moncada I, Patel HR, Chevallier D, Krajka K, Henneges C, Dickson R, Büttner H. Effects of tadalafil treatment on erectile function recovery following bilateral nerve-sparing radical prostatectomy: a randomised placebo-controlled study (REACTT). Eur Urol. 2014 Mar;65(3):587-96. doi: 10.1016/j.eururo.2013.09.051. Epub 2013 Oct 13.

title: Effects of Tadalafil Treatment on Erectile Function Recovery Following Bilateral Nerve-sparing Radical Prostatectomy: A Randomised Placebo-controlled Study (REACTT)

location_country:
Italy
Switzerland
Netherlands
France
Poland
Belgium
Spain
Germany
United Kingdom
Canada

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


title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study of the Safety and Response Rate of 3 Subcutaneously Administered Doses of 5 X 10^7 PFU RO5217790 in Patients With High Grade Cervical Intraepithelial Neoplasia Grade 2 or 3 Associated With High Risk HPV Infection

summary: This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety and the efficacy of RO5217790 on histologic resolution in participants with high grade CIN associated with HR-HPV infection. Participants will be randomized to receive 3 subcutaneous injections of either placebo or RO5217790 on Days 1, 8, and 15. Study assessments will be made at Baseline, at Month 3 and 6, and every 6 months thereafter for an overall of 2.5 years.

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
France
Puerto Rico
Belgium
Spain
United States


study_start_date_type: Actual

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Europe B.V.

location_country:
Italy
Austria
Netherlands
France
Czechia
Poland
Slovakia
Belgium
Belarus
Germany
United Kingdom

acronym: Neptune II

ipd_sharing: Yes

title: An Open-label, Long Term, Multi-center Study to Assess the Safety and Efficacy of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component

summary: Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.


title: Efficacy and Safety Comparison of Epiduo Gel Associated With Lymecycline 300 mg Capsules Versus Epiduo Vehicle Gel Associated With Lymecycline 300 mg Capsules in the Treatment of Moderate to Severe Acne Vulgaris

acronym: TEAM

summary:
Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face.

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris.

The safety of the two treatment regimens will also be evaluated.

lead_sponsor: Galderma R&D

location_country: Italy Brazil Sweden Mexico France Poland Belgium Australia Germany


ReferenceCitation: Holz FG, Roider J, Ogura Y, Korobelnik JF, Simader C, Groetzbach G, Vitti R, Berliner AJ, Hiemeyer F, Beckmann K, Zeitz O, Sandbrink R. VEGF Trap-Eye for macular oedema secondary to central retinal vein occlusion: 6-month results of the phase III GALILEO study. Br J Ophthalmol. 2013 Mar;97(3):278-84. doi: 10.1136/bjophthalmol-2012-301504. Epub 2013 Jan 7. Erratum in: Br J Ophthalmol. 2015 Dec;99(12):1746.

family: Holz

full_name: Frank G Holz

given: Frank G

family: Roider

full_name: Johann Roider

given: Johann

family: Ogura

full_name: Yuichiro Ogura

given: Yuichiro

family: Korobelnik

full_name: Jean-François Korobelnik

given: Jean-François

family: Simader

full_name: Christian Simader

given: Christian

family: Groetzbach

full_name: Georg Groetzbach

given: Georg

family: Vitti

full_name: Robert Vitti

family: Berliner

full_name: Alyson J Berliner

given: Alyson J

family: Hiemeyer

full_name: Florian Hiemeyer

given: Florian

family: Beckmann

full_name: Karola Beckmann

given: Karola

family: Zeitz

full_name: Oliver Zeitz

given: Oliver

family: Sandbrink

full_name: Rupert Sandbrink

given: Rupert

journal_name: British Journal of Ophthalmology

ReferenceCitation: Korobelnik JF, Holz FG, Roider J, Ogura Y, Simader C, Schmidt-Erfurth U, Lorenz K, Honda M, Vitti R, Berliner AJ, Hiemeyer F, Stemper B, Zeitz O, Sandbrink R; GALILEO Study Group. Intravitreal Aflibercept Injection for Macular Edema Resulting from Central Retinal Vein Occlusion: One-Year Results of the Phase 3 GALILEO Study. Ophthalmology. 2014 Jan;121(1):202-208. doi: 10.1016/j.ophtha.2013.08.012. Epub 2013 Sep 29.

full_name: Frank G. Holz

given: Frank G.

family: Schmidt-Erfurth

full_name: Ursula Schmidt-Erfurth

given: Ursula

family: Lorenz

full_name: Katrin Lorenz

given: Katrin

family: Honda

full_name: Miki Honda

given: Miki

full_name: Alyson J. Berliner

given: Alyson J.

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

location_country:
Italy
Austria
France
Japan
Singapore
Hungary
Australia
Germany
Latvia
Korea, Republic of

title: A Randomized, Double-masked, Sham-controlled Phase 3 Study of the Efficacy, Safety and Tolerability of Repeated Intravitreal Administration of VEGF Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)

summary: To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion


title: Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial

acronym: POINT

summary:
A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor ischemic strokes (with an NIH Stroke Scale [NIHSS] score less than or equal to 3).

TIAs are common [25], and are often harbingers of disabling strokes. Approximately 250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8 years [32], there are approximately 2.4 million TIA survivors. In a national survey, one in fifteen of those over 65 years old reported a history of TIA [33], which is equivalent to a prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed transient neurological events, the true incidence of TIA may be twice as high as the rates of diagnosis [33]. Based on our review of the National Inpatient Sample for 1997-2003, there were an average of 200,000 hospital admissions for TIA each year, with annual charges climbing quickly in the period to $2.6 billion in 2003.

Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or ischemic vascular death at 90 days.

status: Terminated

ReferenceType: background

ReferenceCitation: Ovbiagele B. Antiplatelet therapy in management of transient ischemic attack: overview and evidence-based rationale. J Emerg Med. 2008 May;34(4):389-96. doi: 10.1016/j.jemermed.2007.08.056. Epub 2008 Jan 18. Review.

ReferenceCitation: Giles MF, Rothwell PM. Risk of stroke early after transient ischaemic attack: a systematic review and meta-analysis. Lancet Neurol. 2007 Dec;6(12):1063-72. Epub 2007 Nov 13. Review.

ReferenceCitation: Kernan WN, Schindler JL. Rapid intervention for TIA: a new standard emerges. Lancet Neurol. 2007 Nov;6(11):940-1.

ReferenceCitation: Rothwell PM. Transient ischaemic attacks: time to wake up. Heart. 2007 Aug;93(8):893-4.

ReferenceCitation: Streifler JY. Early stroke risk after a transient ischemic attack: can it be minimized? Stroke. 2008 Jun;39(6):1655-6. doi: 10.1161/STROKEAHA.107.510248. Epub 2008 Mar 27.

ReferenceCitation: Dean N, Shuaib A. Transient ischaemic attacks: unstable, treatable, neglected. Lancet. 2007 Oct 20;370(9596):1398-400.

ReferenceCitation: Kennedy J, Hill MD, Ryckborst KJ, Eliasziw M, Demchuk AM, Buchan AM; FASTER Investigators. Fast assessment of stroke and transient ischaemic attack to prevent early recurrence (FASTER): a randomised controlled pilot trial. Lancet Neurol. 2007 Nov;6(11):961-9. Epub 2007 Oct 10.

ReferenceCitation: Geisler T, Zürn C, Paterok M, Göhring-Frischholz K, Bigalke B, Stellos K, Seizer P, Kraemer BF, Dippon J, May AE, Herdeg C, Gawaz M. Statins do not adversely affect post-interventional residual platelet aggregation and outcomes in patients undergoing coronary stenting treated by dual antiplatelet therapy. Eur Heart J. 2008 Jul;29(13):1635-43. doi: 10.1093/eurheartj/ehn212. Epub 2008 May 24.

ReferenceCitation: Lotfi A, Schweiger MJ, Giugliano GR, Murphy SA, Cannon CP; TIMI 22 Investigators. High-dose atorvastatin does not negatively influence clinical outcomes among clopidogrel treated acute coronary syndrome patients--a Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) analysis. Am Heart J. 2008 May;155(5):954-8. doi: 10.1016/j.ahj.2007.12.009. Epub 2008 Feb 19.

ReferenceCitation: Mitsios JV, Papathanasiou AI, Rodis FI, Elisaf M, Goudevenos JA, Tselepis AD. Atorvastatin does not affect the antiplatelet potency of clopidogrel when it is administered concomitantly for 5 weeks in patients with acute coronary syndromes. Circulation. 2004 Mar 23;109(11):1335-8. Epub 2004 Mar 15.

ReferenceCitation: Riondino S, Petrini N, Donato L, Torromeo C, Tanzilli G, Pulcinelli FM, Barillà F. Effects of rosuvastatin on platelet inhibition by clopidogrel in cardiovascular patients. J Thromb Thrombolysis. 2009 Aug;28(2):151-5. doi: 10.1007/s11239-008-0254-6. Epub 2008 Jul 18.

ReferenceCitation: Saw J, Brennan DM, Steinhubl SR, Bhatt DL, Mak KH, Fox K, Topol EJ; CHARISMA Investigators. Lack of evidence of a clopidogrel-statin interaction in the CHARISMA trial. J Am Coll Cardiol. 2007 Jul 24;50(4):291-5. Epub 2007 Jul 10.

ReferenceCitation: Saw J, Steinhubl SR, Berger PB, Kereiakes DJ, Serebruany VL, Brennan D, Topol EJ; Clopidogrel for the Reduction of Events During Observation Investigators. Lack of adverse clopidogrel-atorvastatin clinical interaction from secondary analysis of a randomized, placebo-controlled clopidogrel trial. Circulation. 2003 Aug 26;108(8):921-4. Epub 2003 Aug 18.

ReferenceCitation: Trenk D, Hochholzer W, Frundi D, Stratz C, Valina CM, Bestehorn HP, Büttner HJ, Neumann FJ. Impact of cytochrome P450 3A4-metabolized statins on the antiplatelet effect of a 600-mg loading dose clopidogrel and on clinical outcome in patients undergoing elective coronary stent placement. Thromb Haemost. 2008 Jan;99(1):174-81. doi: 10.1160/TH07-08-0503.

ReferenceCitation: Johnston SC, Gress DR, Browner WS, Sidney S. Short-term prognosis after emergency department diagnosis of TIA. JAMA. 2000 Dec 13;284(22):2901-6.

ReferenceCitation: Coutts SB, Eliasziw M, Hill MD, Scott JN, Subramaniam S, Buchan AM, Demchuk AM; VISION study group. An improved scoring system for identifying patients at high early risk of stroke and functional impairment after an acute transient ischemic attack or minor stroke. Int J Stroke. 2008 Feb;3(1):3-10. doi: 10.1111/j.1747-4949.2008.00182.x.

ReferenceCitation: Coutts SB, Simon JE, Eliasziw M, Sohn CH, Hill MD, Barber PA, Palumbo V, Kennedy J, Roy J, Gagnon A, Scott JN, Buchan AM, Demchuk AM. Triaging transient ischemic attack and minor stroke patients using acute magnetic resonance imaging. Ann Neurol. 2005 Jun;57(6):848-54.

ReferenceCitation: Algra A, van Gijn J, Halkes PH, Kappelle LJ, Koudstaal PJ; ESPRIT Study Group. Interpretation of ESPRIT in the FASTER trial. Lancet Neurol. 2008 Mar;7(3):198-9; author reply 199. doi: 10.1016/S1474-4422(08)70030-9.

ReferenceCitation: Lavallée PC, Meseguer E, Abboud H, Cabrejo L, Olivot JM, Simon O, Mazighi M, Nifle C, Niclot P, Lapergue B, Klein IF, Brochet E, Steg PG, Lesèche G, Labreuche J, Touboul PJ, Amarenco P. A transient ischaemic attack clinic with round-the-clock access (SOS-TIA): feasibility and effects. Lancet Neurol. 2007 Nov;6(11):953-60.

ReferenceCitation: Luengo-Fernandez R, Gray AM, Rothwell PM. Effect of urgent treatment for transient ischaemic attack and minor stroke on disability and hospital costs (EXPRESS study): a prospective population-based sequential comparison. Lancet Neurol. 2009 Mar;8(3):235-43. doi: 10.1016/S1474-4422(09)70019-5. Epub 2009 Feb 4.

ReferenceCitation: Yusuf S, Diener HC, Sacco RL, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlöf B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, VanderMaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Telmisartan to prevent recurrent stroke and cardiovascular events. N Engl J Med. 2008 Sep 18;359(12):1225-37. doi: 10.1056/NEJMoa0804593. Epub 2008 Aug 27.

family: Yusuf

full_name: Salim Yusuf

given: Salim

family: Diener

full_name: Hans-Christoph Diener

given: Hans-Christoph

family: Sacco

full_name: Ralph L. Sacco

given: Ralph L.

family: Cotton

full_name: Daniel Cotton

given: Daniel

family: Ôunpuu

full_name: Stephanie Ôunpuu

given: Stephanie

family: Lawton

full_name: William A. Lawton

given: William A.

family: Palesch

full_name: Yuko Palesch

given: Yuko

family: Martin

full_name: Reneé H. Martin

given: Reneé H.

family: Albers

full_name: Gregory W. Albers

given: Gregory W.

family: Bath

full_name: Philip Bath

given: Philip

family: Bornstein

full_name: Natan Bornstein

given: Natan

family: Chan

full_name: Bernard P.L. Chan

given: Bernard P.L.

family: Chen

full_name: Sien-Tsong Chen

given: Sien-Tsong

family: Cunha

full_name: Luis Cunha

given: Luis

family: Dahlöf

full_name: Björn Dahlöf

given: Björn

family: De Keyser

full_name: Jacques De Keyser

given: Jacques

family: Donnan

full_name: Geoffrey A. Donnan

given: Geoffrey A.

family: Estol

full_name: Conrado Estol

given: Conrado

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Limoges

repository_institution: University of Nottingham - Repository@Nottingham

repository_institution: Seoul National University - Seoul National University Open Repository

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Limoges

repositories_institution: Seoul National University - Seoul National University Open Repository

repositories_institution: University of Nottingham - Repository@Nottingham

title: Telmisartan to Prevent Recurrent Stroke and Cardiovascular Events

ReferenceCitation: Sacco RL, Diener HC, Yusuf S, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlöf B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, Vandermaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke. N Engl J Med. 2008 Sep 18;359(12):1238-51. doi: 10.1056/NEJMoa0805002. Epub 2008 Aug 27.

title: Aspirin and Extended-Release Dipyridamole versus Clopidogrel for Recurrent Stroke

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ReferenceCitation: Wang Y, Johnston SC; CHANCE Investigators. Rationale and design of a randomized, double-blind trial comparing the effects of a 3-month clopidogrel-aspirin regimen versus aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event. Am Heart J. 2010 Sep;160(3):380-386.e1. doi: 10.1016/j.ahj.2010.05.017.

ReferenceCitation: Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.

ReferenceCitation: Meschia JF, Walton RL, Farrugia LP, Ross OA, Elm JJ, Farrant M, Meurer WJ, Lindblad AS, Barsan W, Ching M, Gentile N, Ross M, Nahab F, Easton JD, Kim AS, Zurita KG, Cucchiara B, Johnston SC. Efficacy of Clopidogrel for Prevention of Stroke Based on CYP2C19 Allele Status in the POINT Trial. Stroke. 2020 Jul;51(7):2058-2065. doi: 10.1161/STROKEAHA.119.028713. Epub 2020 Jun 17.

name: Departments of Neurology (J.F.M.), Mayo Clinic, Jacksonville, FL.

name: Neuroscience (R.L.W., L.P.F., O.A.R.), Mayo Clinic, Jacksonville, FL.

name: Clinical Genomics (O.A.R.), Mayo Clinic, Jacksonville, FL.

name: Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E.).

name: Department of Neurology, University of California, San Francisco (M.F., J.D.E., A.S.K., K.G.Z.).

name: Departments of Emergency Medicine (W.J.M., W.B.), University of Michigan, Ann Arbor.

name: Neurology (W.J.M., W.B.), University of Michigan, Ann Arbor.

name: The Emmes Corporation, Rockville, MD (A.S.L.).

name: Department of Neurology, University of Buffalo Jacobs School of Medicine and Biomedical Sciences, NY (M.C.).

name: Department of Emergency Medicine, Temple University, Philadelphia, PA (N.G.).

name: Department of Emergency Medicine and Neurology, Emory University, Atlanta, GA (M.R., F.N.).

name: Department of Neurology, University of Pennsylvania, Philadelphia (B.C.).

name: Dean’s Office, Dell Medical School, Dell Medical Center, Austin, TX (S.C.J.).

title: Efficacy of Clopidogrel for Prevention of Stroke Based on CYP2C19 Allele Status in the POINT Trial

ReferenceCitation: Kamel H, Zhang C, Kleindorfer DO, Levitan EB, Howard VJ, Howard G, Soliman EZ, Johnston SC. Association of Black Race With Early Recurrence After Minor Ischemic Stroke or Transient Ischemic Attack: Secondary Analysis of the POINT Randomized Clinical Trial. JAMA Neurol. 2020 May 1;77(5):601-605. doi: 10.1001/jamaneurol.2020.0010.

name: Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute and Department of Neurology, Weill Cornell Medicine, New York, New York

name: Department of Neurology, University of Cincinnati, Ohio

name: Department of Epidemiology, University of Alabama at Birmingham, Birmingham

name: Department of Biostatistics, University of Alabama at Birmingham, Birmingham

name: Epidemiological Cardiology Research Center, Division of Cardiology, Wake Forest School of Medicine, Winston-Salem, North Carolina

name: Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, North Carolina

name: Department of Internal Medicine–Cardiology, Wake Forest School of Medicine, Winston-Salem, North Carolina

name: Dell Medical School, Dean’s Office, University of Texas at Austin, Austin

title: Association of Black Race With Early Recurrence After Minor Ischemic Stroke or Transient Ischemic Attack

ReferenceCitation: Cucchiara B, Elm J, Easton JD, Coutts SB, Willey JZ, Biros MH, Ross MA, Johnston SC. Disability After Minor Stroke and Transient Ischemic Attack in the POINT Trial. Stroke. 2020 Mar;51(3):792-799. doi: 10.1161/STROKEAHA.119.027465. Epub 2020 Feb 12.

name: From the Department of Neurology, University of Pennsylvania, Philadelphia (B.C.)

name: Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.E.)

name: Department of Neurology, University of California, San Francisco (J.D.E.)

name: Department of Clinical Neurosciences, Radiology and Community Health Sciences, University of Calgary, Hotchkiss Brain Institute, AB, Canada (S.B.C.)

name: Department of Neurology, Columbia University, New York, NY (J.Z.W.)

name: Emergency Medicine, University of Minnesota, Minneapolis (M.H.B.)

name: Department of Neurology, Emory University, Atlanta, GA (M.A.R.)

name: Emergency Medicine Dean’s Office, Dell Medical School, University of Texas-Austin (S.C.J.).

title: Disability After Minor Stroke and Transient Ischemic Attack in the POINT Trial

ReferenceCitation: Farrant M, Easton JD, Adelman EE, Cucchiara BL, Barsan WG, Tillman HJ, Elm JJ, Kim AS, Lindblad AS, Palesch YY, Zhao W, Pauls K, Walsh KB, Martí-Fàbregas J, Bernstein RA, Johnston SC. Assessment of the End Point Adjudication Process on the Results of the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial: A Secondary Analysis. JAMA Netw Open. 2019 Sep 4;2(9):e1910769. doi: 10.1001/jamanetworkopen.2019.10769.

name: Department of Neurology, University of Wisconsin School of Medicine and Public Health, Madison

name: University of Pennsylvania, Philadelphia

name: Department of Emergency Medicine, University of Michigan, Ann Arbor

name: Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston

name: The Emmes Corporation, Rockville, Maryland

name: Department of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio

name: Department of Neurology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

name: Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois

name: Dean’s Office, Dell Medical School, The University of Texas at Austin

ReferenceCitation: Johnston SC, Elm JJ, Easton JD, Farrant M, Barsan WG, Kim AS, Lindblad AS, Palesch YY, Zurita KG, Albers GW, Cucchiara BL, Kleindorfer DO, Lutsep HL, Pearson C, Sethi P, Vora N; POINT and Neurological Emergencies Treatment Trials Network Investigators. Time Course for Benefit and Risk of Clopidogrel and Aspirin After Acute Transient Ischemic Attack and Minor Ischemic Stroke. Circulation. 2019 Aug 20;140(8):658-664. doi: 10.1161/CIRCULATIONAHA.119.040713. Epub 2019 Jun 26.

name: Dean’s Office, Dell Medical School, University of Texas, Austin (S.C.J.).

name: Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E., Y.Y.P.).

name: Department of Neurology, University of California, San Francisco (J.D.E., M.F., A.S.K., K.G.Z.).

name: Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B.).

name: Department of Neurology and Neurological Sciences, Stanford Stroke Center, Stanford University, Palo Alto, CA (G.W.A., N.V.).

name: Department of Neurology, University of Pennsylvania, Philadelphia (B.L.C.).

name: Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, OH (D.O.K.).

name: Department of Neurology, Oregon Health and Science University, Portland (H.L.L.).

name: Department of Emergency Medicine, Wayne State University School of Medicine, Detroit, MI (C.P.).

name: Cone Health Comprehensive Stroke Center/Guilford Neurologic Associates, Greensboro, NC (P.S.).

name: For the POINT and Neurological Emergencies Treatment Trials Network Investigators

title: Time Course for Benefit and Risk of Clopidogrel and Aspirin After Acute Transient Ischemic Attack and Minor Ischemic Stroke

ReferenceCitation: Tillman H, Johnston SC, Farrant M, Barsan W, Elm JJ, Kim AS, Lindblad AS, Palesch YY, Easton JD. Risk for Major Hemorrhages in Patients Receiving Clopidogrel and Aspirin Compared With Aspirin Alone After Transient Ischemic Attack or Minor Ischemic Stroke: A Secondary Analysis of the POINT Randomized Clinical Trial. JAMA Neurol. 2019 Jul 1;76(7):774-782. doi: 10.1001/jamaneurol.2019.0932.

name: Dean’s Office, Dell Medical School, University of Texas at Austin, Austin

name: Department of Neurology, University of California, San Francisco, San Francisco

ReferenceCitation: Johnston SC, Easton JD, Farrant M, Barsan W, Conwit RA, Elm JJ, Kim AS, Lindblad AS, Palesch YY; Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators. Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA. N Engl J Med. 2018 Jul 19;379(3):215-225. doi: 10.1056/NEJMoa1800410. Epub 2018 May 16.

name: From the Dean’s Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology, University of California, San Francisco, San Francisco (J.D.E., M.F., A.S.K.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.B.); the Division of Clinical Research, National Institute of Neurological Disorders and Stroke, Bethesda (R.A.C.), and Emmes, Rockville (A.S.L.) — both in Maryland; and the Data Coordination Unit, Department of Public Health...

repository_institution: West Virginia University - The Research Repository @ WVU

repositories_institution: West Virginia University - The Research Repository @ WVU

title: Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA

ReferenceCitation: Zhao W, Pauls K. Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system. Clin Trials. 2016 Apr;13(2):223-33. doi: 10.1177/1740774515611889. Epub 2015 Oct 13.

name: Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA

title: Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system

ReferenceCitation: Johnston SC, Easton JD, Farrant M, Barsan W, Battenhouse H, Conwit R, Dillon C, Elm J, Lindblad A, Morgenstern L, Poisson SN, Palesch Y. Platelet-oriented inhibition in new TIA and minor ischemic stroke (POINT) trial: rationale and design. Int J Stroke. 2013 Aug;8(6):479-83. doi: 10.1111/ijs.12129.

name: Department of Neurology, University of California, San Francisco, CA, USA

name: Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA

name: Emergency Medicine, University of Michigan Health System, Ann Arbor, MI, USA

name: Data Coordination Unit, Department of Public Health Services, Medical University of South Carolina, Charleston, SC, USA

name: Office of Clinical Research, National Institute of Neurological Disorders, Bethesda, MD, USA

name: The EMMES Corporation, Rockville, MD, USA

name: Department of Neurology, University of Colorado School of Medicine, Denver, CO, USA

repositories_institution:
PubMed Central - Europe PMC
University of Michigan - Deep Blue

title: Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial: Rationale and design

location_country:
United States
Mexico
Germany
Finland
France
Australia
New Zealand
Spain
Canada
United Kingdom

location_facility: University Hospital Schleswig-Holstein Kiel Campus

location_facility: UCSD Medical Center - Hillcrest Hospital

location_facility: Lincoln Medical and Mental Health Center

location_facility: University of Minnesota Medical Center Hospital

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hospital of the University of Pennsylvania

location_facility: Mexican Association for Clinical Research

location_facility: Southern Illinois University Memorial Medical Center

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: University of Calgary - Foothills Campus

location_facility: Medical University of South Carolina University Hospital

location_facility: Henrico Doctors' Hospital - Parham Campus

location_facility: Valley Baptist Medical Center - Harlingen

location_facility: Adolphe de Rothschild Ophthalmologic Foundation

location_facility: University of Texas Health Science Center San Antonio

location_facility: Central Hospital Dr. Ignacio Morones Prieto

location_facility: Henrico Doctors' Hospital - Forest Campus

location_facility: Great Falls Clinic Hospital, Great Falls

location_facility: Pennsylvania State Hershey Medical Center

location_facility: Texas Health Presbyterian Hospital - Dallas

location_facility: Oregon Health and Science University Hospital

location_facility: New York Presbyterian / Columbia University Medical Center

location_facility: Banner University Medical Center - Tucson Campus


ReferenceCitation: Malattia C, Ruperto N, Pederzoli S, Palmisani E, Pistorio A, Wouters C, Dolezalova P, Flato B, Garay S, Giancane G, Wells C, Douglass W, Brunner HI, De Benedetti F, Ravelli A; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Tocilizumab may slow radiographic progression in patients with systemic or polyarticular-course juvenile idiopathic arthritis: post hoc radiographic analysis from two randomized controlled trials. Arthritis Res Ther. 2020 Sep 10;22(1):211. doi: 10.1186/s13075-020-02303-y.

family: Malattia

full_name: Clara Malattia

given: Clara

name: for the Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG)

family: Ruperto

full_name: Nicolino Ruperto

given: Nicolino

family: Pederzoli

full_name: Silvia Pederzoli

given: Silvia

family: Palmisani

full_name: Elena Palmisani

given: Elena

family: Pistorio

full_name: Angela Pistorio

given: Angela

family: Wouters

full_name: Carine Wouters

given: Carine

family: Dolezalova

full_name: Pavla Dolezalova

given: Pavla

family: Flato

full_name: Berit Flato

given: Berit

family: Garay

full_name: Stella Garay

given: Stella

family: Giancane

full_name: Gabriella Giancane

given: Gabriella

family: Wells

full_name: Chris Wells

given: Chris

family: Douglass

full_name: Wendy Douglass

given: Wendy

family: Brunner

full_name: Hermine I. Brunner

given: Hermine I.

family: De Benedetti

full_name: Fabrizio De Benedetti

given: Fabrizio

family: Ravelli

full_name: Angelo Ravelli

given: Angelo

journal_name: Arthritis Research & Therapy

repository_institution: University of Oslo - Duo Research Archive

repositories:
LIRIAS (KU Leuven)
PubMed Central
www.duo.uio.no

ReferenceCitation: Pardeo M, Wang J, Ruperto N, Alexeeva E, Chasnyk V, Schneider R, Horneff G, Huppertz HI, Minden K, Onel K, Zemel L, Martin A, Koné-Paut I, Siamopoulou-Mavridou A, Silva CA, Porter-Brown B, Bharucha KN, Brunner HI, De Benedetti F; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Neutropenia During Tocilizumab Treatment Is Not Associated with Infection Risk in Systemic or Polyarticular-course Juvenile Idiopathic Arthritis. J Rheumatol. 2019 Sep;46(9):1117-1126. doi: 10.3899/jrheum.180795. Epub 2019 Mar 1.

family: Pardeo

full_name: Manuela Pardeo

given: Manuela

ReferenceCitation: Brunner HI, Ruperto N, Zuber Z, Keane C, Harari O, Kenwright A, Lu P, Cuttica R, Keltsev V, Xavier RM, Calvo I, Nikishina I, Rubio-Pérez N, Alexeeva E, Chasnyk V, Horneff G, Opoka-Winiarska V, Quartier P, Silva CA, Silverman E, Spindler A, Baildam E, Gámir ML, Martin A, Rietschel C, Siri D, Smolewska E, Lovell D, Martini A, De Benedetti F; Paediatric Rheumatology International Trials Organisation PRINTO; Pediatric Rheumatology Collaborative Study Group (PRCSG). Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis: results from a phase 3, randomised, double-blind withdrawal trial. Ann Rheum Dis. 2015 Jun;74(6):1110-7. doi: 10.1136/annrheumdis-2014-205351. Epub 2014 May 16.

repository_institution: University of Padua - Padua Research Archive

repository_institution: University of Padova - Padua Research Archive

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

location_country:
Italy
Brazil
Peru
Mexico
Spain
Germany
France
Poland
Belgium
Argentina
Australia
Russian Federation
United States
United Kingdom
Canada

location_facility: Princess Margaret Children'S Hospital; Department of Immunology

location_facility: Wojewodzki Szpital Dzieciecy Im. J. Brudzinskiego

location_facility: Saint-Petersburg State; Pediatrics Medical Academy

location_facility: Children's National Medical Center; Pediatric Rheumatology

location_facility: Hospital Universitario Reina Sofia; Servicio de Reumatologia

location_facility: Royal Liverpool Childrens Hospital; Rheumatology

location_facility: Hospital Ramon y Cajal ; Servicio de Reumatologia

location_facility: Samara Regional Clinical Cardiology Dispensary

location_facility: Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica

location_facility: Hôpital Lapeyronie; Immuno-Rhumatologie Pr Jorgensen

location_facility: Hopitaux De Brabois; Medecine Infantile II

location_facility: Nuovo Ospedale Pediatrico Meyer; Reumatologia - Clinica Pediatrica 1°

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria

location_facility: FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences

location_facility: Hospital Universitario Virgen Macarena; Servicio de Reumatologia

location_facility: Hackensack University Medical Center; Pediatric Rheumatology

location_facility: SI Sceintific children health center RAMS

location_facility: Royal Children'S Hospital; Paediatric Rheumatology

location_facility: Instituto de Puericultura E Pediatria Martagão Gesteira

location_facility: Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina

location_facility: Centro Medico Privado de Reumatologia; Reumathology

location_facility: Univ. Di Padova - Dip. Di Pediatria - Unita' Reumatol. Pediatrica

location_facility: Clinica San Felipe; Consultorio de Reumatología

location_facility: Clinica San Borja; Servicio De Reumatologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Reumatología

location_facility: Hospital Universitario Pedro Ernesto; Nucleo de Estudos da Saude do Adolescente

location_facility: Wojewodzki Specjalistyczny Szpital Dzieciecy Sw Ludwika; Oddzial Dzieci Starszych

location_facility: Dzieciecy Szpital Kliniczny IM. Prof. A. Gebali; Oddzial Pediatrii Chorob Pluc I Reumatologii

location_facility: Asklepios Klinik; Zentrum fuer Allgemeine Paediatrie und Neonatologie

location_facility: University of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research Unit

location_facility: Centrum Pediatrii im Jana Pawla II; Oddzial Reumatologiczny

location_facility: Hospital das Clinicas - FMUSP; Instituto da Crianca - Reumatologia

location_facility: British Columbia Children's Hospital; Rheumatology

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher

location_facility: Klinik Bremen-Mitte; Prof. Hess-Kinderklinik

location_facility: The University of Chicago;Department of Pediatrics

location_facility: I. M. Sechenov Moscow State Medical University; The Ministry of Health and Social Development of RF

location_facility: ASST CENTRO SPECIALISTICO ORTOPEDICO TRAUMATO-LOGICO GAETANO PINI/CTO; Reumatol. Pediatrica

location_facility: Uniwersytecki Szpital Kliniczny Nr 4 im. M. Konopnickiej; Oddz. Kardiolog. i Reumatolog. dla Dzieci

location_facility: Hôpital Pellegrin; Urgences Pédiatriques

location_facility: Cincinnati Children'S Hospital Medical Center; Division of Rheumatology

location_facility: Clementine Hospital; Kinder- und Jugendrheumatologie

location_facility: Great Ormond Street Hospital for Sick Children; Institute of Child Health

location_facility: Southern District Medical Center of Roszdrav

location_facility: Connecticut Children's Medical Center; 5E Clinical Trials Unit

location_facility: Westmead Hospital; Paediatric Rheumatology

title: A 24 Week Randomized, Double-blind, Placebo-controlled Withdrawal Trial With a 16 Week Open-label lead-in Phase, and 64 Week Open-label Follow-up, to Evaluate the Effect on Clinical Response and the Safety of Tocilizumab in Patients With Active Polyarticular-course Juvenile Idiopathic Arthritis

summary: This 3-part study evaluated the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or were intolerant of methotrexate. In Part I of the study, all patients received intravenous (iv) infusions of tocilizumab (8 mg/kg for patients ≥ 30kg, 8 mg/kg or 10 mg/kg for patients < 30kg) every 4 weeks for 16 weeks. In Part II of the study, patients with an adequate response in Part I were randomized to receive either tocilizumab at the same dose as in Part I or placebo every 4 weeks for up to 24 weeks. In Part III of the study, patients received tocilizumab at the same dose as in Part I every 4 weeks for up to another 64 weeks. Standard of care therapy with or without non-steroidal anti-inflammatory drugs (NSAID), corticosteroids, or methotrexate was continued throughout the study.


lead_sponsor: Teva Pharmaceutical Industries, Ltd.

location_country:
Romania
Russian Federation
Ukraine
France
Poland
Lithuania
Canada
Turkey
Sweden
Netherlands
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Austria
Serbia
Czechia
Israel
Georgia
Spain
Estonia

location_facility:
Teva Investigational Site 3142
Teva Investigational Site 3809
Teva Investigational Site 555
Teva Investigational Site 5116
Teva Investigational Site 1098
Teva Investigational Site 3135
Teva Investigational Site 5705
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title: A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MS

summary: The purpose of this study is to make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.

status_simplified: Unknown


ReferenceCitation: Dieterich D, Asselah T, Guyader D, Berg T, Schuchmann M, Mauss S, Ratziu V, Ferenci P, Larrey D, Maieron A, Stern JO, Ozan M, Datsenko Y, Böcher WO, Steinmann G. SILEN-C3, a phase 2 randomized trial with faldaprevir plus pegylated interferon α-2a and ribavirin in treatment-naive hepatitis C virus genotype 1-infected patients. Antimicrob Agents Chemother. 2014 Jun;58(6):3429-36. doi: 10.1128/AAC.02497-13. Epub 2014 Apr 7.

name: Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, New York, USA

family: Dieterich

full_name: Douglas Dieterich

given: Douglas

name: Service d'Hépatologie, AP-HP Hôpital Beaujon, INSERM UMR 1149, CRI, Université Paris Diderot, Clichy, France

family: Asselah

full_name: Tarik Asselah

given: Tarik

name: Department of Liver Diseases, University of Rennes 1, Rennes, France

family: Guyader

full_name: Dominique Guyader

given: Dominique

name: Sektion Hepatologie, Department für Innere Medizin, Neurologie und Dermatologie, Klinik für Gastroenterologie und Rheumatologie, Universitätsklinik Leipzig AöR, Leipzig, Germany

family: Berg

full_name: Thomas Berg

given: Thomas

name: Klinik für Innere Medizin, Klinikum Konzstanz, Constance, Germany

family: Schuchmann

full_name: Marcus Schuchmann

given: Marcus

name: Center for HIV and Hepatogastroenterology, Düsseldorf, Germany

family: Mauss

full_name: Stefan Mauss

given: Stefan

name: Service d'Hépato-Gastroentérologie, Hôpital Pitié-Salpêtrière, Paris, France

family: Ratziu

full_name: Vlad Ratziu

given: Vlad

name: Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria

family: Ferenci

full_name: Peter Ferenci

given: Peter

name: Liver Unit-IRB-INSERM1040, Hôpital Saint Eloi, Montpellier, France

family: Larrey

full_name: Dominique Larrey

name: Department of Gastroenterology and Hepatology, Elisabethinen Hospital Linz, Linz, Austria

family: Maieron

full_name: Andreas Maieron

given: Andreas

name: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA

family: Stern

full_name: Jerry O. Stern

given: Jerry O.

family: Ozan

full_name: Melek Ozan

given: Melek

name: Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany

family: Datsenko

full_name: Yakov Datsenko

given: Yakov

name: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany

family: Böcher

full_name: Wulf Otto Böcher

given: Wulf Otto

family: Steinmann

full_name: Gerhard Steinmann

given: Gerhard

journal_name: Antimicrobial Agents and Chemotherapy

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

title: SILEN-C3, a Phase 2 Randomized Trial with Faldaprevir plus Pegylated Interferon α-2a and Ribavirin in Treatment-Naive Hepatitis C Virus Genotype 1-Infected Patients

location_country:
Austria
Germany
France
Romania
United States
Canada

location_facility: 1220.40.3304A Boehringer Ingelheim Investigational Site

location_facility: 1220.40.3306A Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4301 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4002 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.3305A Boehringer Ingelheim Investigational Site

location_facility: 1220.40.1005 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.002 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.3302A Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4906 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4904 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.005 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.007 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.1001 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4902 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.1003 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.004 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.1002 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.3301A Boehringer Ingelheim Investigational Site

location_facility: 1220.40.3303A Boehringer Ingelheim Investigational Site

location_facility: 1220.40.003 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4303 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.1004 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4001 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4909 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4908 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4905 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4003 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.006 Boehringer Ingelheim Investigational Site

title: Antiviral Effect and Safety of Once Daily BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naive Patients for 12 or 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Randomised, Open Label, Phase II)

summary: To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

summary: The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full etc.)

ReferenceCitation: Vlachopoulos C, Oelke M, Maggi M, Mulhall JP, Rosenberg MT, Brock GB, Esler A, Büttner H. Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials. Int J Clin Pract. 2015 Dec;69(12):1496-507. doi: 10.1111/ijcp.12722. Epub 2015 Aug 24.

name: 1st Department of Cardiology; Athens Medical School; Athens Greece

family: Vlachopoulos

full_name: C. Vlachopoulos

given: C.

name: Department of Urology; Hannover Medical School; Hannover Germany

family: Oelke

full_name: M. Oelke

given: M.

family: Maggi

full_name: M. Maggi

name: Memorial Sloan-Kettering Cancer Center; New York NY USA

family: Mulhall

full_name: J. P. Mulhall

given: J. P.

family: Rosenberg

full_name: M. T. Rosenberg

given: M. T.

name: University of Western Ontario; London ON Canada

family: Brock

full_name: G. B. Brock

given: G. B.

name: Inventiv Health Clinical; Indianapolis IN USA

family: Esler

full_name: A. Esler

given: A.

name: Eli Lilly Biomedicines BU - Men's Health Therapeutic Area Europe, c/o Lilly Deutschland; GmbH; Bad Homburg Germany

family: Büttner

full_name: H. Büttner

given: H.

journal_name: International Journal of Clinical Practice

ReferenceCitation: Giuliano F, Oelke M, Jungwirth A, Hatzimouratidis K, Watts S, Cox D, Viktrup L. Tadalafil once daily improves ejaculatory function, erectile function, and sexual satisfaction in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia and erectile dysfunction: results from a randomized, placebo- and tamsulosin-controlled, 12-week double-blind study. J Sex Med. 2013 Mar;10(3):857-65. doi: 10.1111/jsm.12039. Epub 2013 Jan 24.

family: Giuliano

full_name: François Giuliano

given: François

full_name: Matthias Oelke

given: Matthias

family: Jungwirth

full_name: Andreas Jungwirth

family: Hatzimouratidis

full_name: Konstantinos Hatzimouratidis

given: Konstantinos

family: Watts

full_name: Steven Watts

given: Steven

family: Cox

full_name: David Cox

given: David

family: Viktrup

full_name: Lars Viktrup

given: Lars

journal_name: The Journal of Sexual Medicine

title: Tadalafil Once Daily Improves Ejaculatory Function, Erectile Function, and Sexual Satisfaction in Men with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia and Erectile Dysfunction: Results from a Randomized, Placebo‐ and Tamsulosin-Controlled, 12-Week Double-Blind Study

ReferenceCitation: Oelke M, Giuliano F, Mirone V, Xu L, Cox D, Viktrup L. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial. Eur Urol. 2012 May;61(5):917-25. doi: 10.1016/j.eururo.2012.01.013. Epub 2012 Jan 20.

family: Mirone

full_name: Vincenzo Mirone

given: Vincenzo

family: Xu

title: Monotherapy with Tadalafil or Tamsulosin Similarly Improved Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in an International, Randomised, Parallel, Placebo-Controlled Clinical Trial

location_country: Italy Austria Mexico Netherlands France Poland Greece Australia Belgium Germany

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