ReferenceCitation: van der Heijde D, Sieper J, Maksymowych WP, Lambert RG, Chen S, Hojnik M, Anderson JK, Pangan AL. Clinical and MRI remission in patients with nonradiographic axial spondyloarthritis who received long-term open-label adalimumab treatment: 3-year results of the ABILITY-1 trial. Arthritis Res Ther. 2018 Mar 27;20(1):61. doi: 10.1186/s13075-018-1556-5.

family: van der Heijde

full_name: Désirée van der Heijde

given: Désirée

family: Sieper

full_name: Joachim Sieper

given: Joachim

family: Maksymowych

full_name: Walter P. Maksymowych

given: Walter P.

family: Lambert

full_name: Robert G. Lambert

given: Robert G.

family: Chen

full_name: Su Chen

given: Su

family: Hojnik

full_name: Maja Hojnik

given: Maja

family: Anderson

full_name: Jaclyn K. Anderson

given: Jaclyn K.

family: Pangan

full_name: Aileen L. Pangan

given: Aileen L.

journal_name: Arthritis Research & Therapy

ReferenceCitation: van der Heijde D, Sieper J, Maksymowych WP, Brown MA, Lambert RG, Rathmann SS, Pangan AL. Spinal inflammation in the absence of sacroiliac joint inflammation on magnetic resonance imaging in patients with active nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2014 Mar;66(3):667-73. doi: 10.1002/art.38283.

name: Leiden University Medical CenterLeidenThe Netherlands

family: Heijde

full_name: Désirée Heijde

name: University of AlbertaEdmonton, AlbertaCanada

name: University of QueenslandBrisbane, QueenslandAustralia

family: Brown

full_name: Matthew A. Brown

given: Matthew A.

full_name: Robert G. W. Lambert

given: Robert G. W.

family: Rathmann

full_name: Suchitrita S. Rathmann

given: Suchitrita S.

repository_institution: Queensland University of Technology - QUT ePrints

title: Spinal Inflammation in the Absence of Sacroiliac Joint Inflammation on Magnetic Resonance Imaging in Patients With Active Nonradiographic Axial Spondyloarthritis

ReferenceCitation: Sieper J, van der Heijde D, Dougados M, Mease PJ, Maksymowych WP, Brown MA, Arora V, Pangan AL. Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1). Ann Rheum Dis. 2013 Jun;72(6):815-22. doi: 10.1136/annrheumdis-2012-201766. Epub 2012 Jul 7.

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

location_country:
United States
United Kingdom
Netherlands
Germany
France
Belgium
Australia
Spain
Canada
Czech Republic

location_facility:
Site Reference ID/Investigator# 21283
Site Reference ID/Investigator# 21249
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Site Reference ID/Investigator# 21241
Site Reference ID/Investigator# 21224
Site Reference ID/Investigator# 21228
Site Reference ID/Investigator# 26883
Site Reference ID/Investigator# 21247

title: A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Axial Spondyloarthritis

summary: This study will evaluate how well adalimumab works in the short and long term in patients with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or psoriatic arthritis.


title: A Randomized, Sham-Injection Controlled, Double-Masked, Multicenter Trial of Ocriplasmin Intravitreal Injection for Treatment of Focal Vitreomacular Adhesion in Subjects With Exudative Age-Related Macular Degeneration (AMD)

summary: This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where this adhesion may be causally associated with worse prognosis).

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: ThromboGenics

location_country:
Italy
United States
France
Belgium
Germany
United Kingdom

location_facility: Klinik für Augenheilkunde, Universitätsklinikum Gießen, Standort Marburg

location_facility: Centre Ophtalmologique d'Imagerie et de Laser

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Universität Lübeck Universitätsklinikum Schleswig-Holstein

location_facility: University of Milan Department of Clinical Science "Luigi Sacco"

location_facility: Largo Agostino Gemelli (University Hospital) Institute of Ophthalmology

location_facility: Augenklinik der Ludwig Maximilians Universität München

location_facility: Wolverhampton Eye Infirmary New Cross Hospital

location_facility: Allegheny Ophthalmic & Orbital Associates, PC

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceType: derived

ReferenceCitation: Benza RL, Ghofrani HA, Grünig E, Hoeper MM, Jansa P, Jing ZC, Kim NH, Langleben D, Simonneau G, Wang C, Busse D, Meier C, Ghio S. Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. J Heart Lung Transplant. 2021 Oct;40(10):1172-1180. doi: 10.1016/j.healun.2021.06.020. Epub 2021 Jul 10.

family: Benza

full_name: Raymond L. Benza

given: Raymond L.

sequence: first

family: Ghofrani

full_name: Hossein-Ardeschir Ghofrani

given: Hossein-Ardeschir

sequence: additional

family: Grünig

full_name: Ekkehard Grünig

given: Ekkehard

family: Hoeper

full_name: Marius M. Hoeper

given: Marius M.

family: Jansa

full_name: Pavel Jansa

given: Pavel

family: Jing

full_name: Zhi-Cheng Jing

given: Zhi-Cheng

family: Kim

full_name: Nick H. Kim

given: Nick H.

family: Langleben

full_name: David Langleben

given: David

family: Simonneau

full_name: Gérald Simonneau

given: Gérald

family: Wang

full_name: Chen Wang

given: Chen

family: Busse

full_name: Dennis Busse

given: Dennis

family: Meier

full_name: Christian Meier

given: Christian

family: Ghio

full_name: Stefano Ghio

given: Stefano

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Journal of Heart and Lung Transplantation

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Saleh S, Becker C, Frey R, Mück W. Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulm Circ. 2016 Mar;6(Suppl 1):S86-96. doi: 10.1086/685404.

name: Clinical Pharmacology, Pharma Research Center, Bayer Pharma, Wuppertal, Germany

family: Saleh

full_name: Soundos Saleh

given: Soundos

family: Becker

full_name: Corina Becker

given: Corina

family: Frey

full_name: Reiner Frey

given: Reiner

family: Mück

full_name: Wolfgang Mück

given: Wolfgang

currency_apc_doaj: USD

journal_name: Pulmonary Circulation

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

license_normalized: no license

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

title: Population Pharmacokinetics and the Pharmacokinetic/Pharmacodynamic Relationship of Riociguat in Patients with Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension

ReferenceCitation: Simonneau G, D'Armini AM, Ghofrani HA, Grimminger F, Jansa P, Kim NH, Mayer E, Pulido T, Wang C, Colorado P, Fritsch A, Meier C, Nikkho S, Hoeper MM. Predictors of long-term outcomes in patients treated with riociguat for chronic thromboembolic pulmonary hypertension: data from the CHEST-2 open-label, randomised, long-term extension trial. Lancet Respir Med. 2016 May;4(5):372-80. doi: 10.1016/S2213-2600(16)30022-4. Epub 2016 Apr 8.

ReferenceCitation: Ghofrani HA, D'Armini AM, Grimminger F, Hoeper MM, Jansa P, Kim NH, Mayer E, Simonneau G, Wilkins MR, Fritsch A, Neuser D, Weimann G, Wang C; CHEST-1 Study Group. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med. 2013 Jul 25;369(4):319-29. doi: 10.1056/NEJMoa1209657.

title: Riociguat for the Treatment of Chronic Thromboembolic Pulmonary Hypertension

location_country:
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Switzerland
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

title: Long-term Extension, Multicentre, Multi-international Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg, 1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

summary: Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.


study_start_date_type: Actual

lead_sponsor: Amgen

location_country:
Greece
Romania
Australia
Russian Federation
Denmark
India
France
Poland
Lithuania
Slovakia
Norway
Canada
Hong Kong
Bulgaria
Hungary
United States
Germany
United Kingdom
Italy
Mexico
New Zealand
Estonia
Latvia

acronym: STARTT

type: EudraCT Number

source: euctr

title: A Multi-center, Randomized, Double Blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults With a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation With an Intramedullary Nail

summary: The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).


ReferenceCitation: Voss MH, Chen D, Reising A, Marker M, Shi J, Xu J, Ostrovnaya I, Seshan VE, Redzematovic A, Chen YB, Patel P, Han X, Hsieh JJ, Hakimi AA, Motzer RJ. PTEN Expression, Not Mutation Status in TSC1, TSC2, or mTOR, Correlates with the Outcome on Everolimus in Patients with Renal Cell Carcinoma Treated on the Randomized RECORD-3 Trial. Clin Cancer Res. 2019 Jan 15;25(2):506-514. doi: 10.1158/1078-0432.CCR-18-1833. Epub 2018 Oct 16.

family: Voss

full_name: Martin H Voss

given: Martin H

family: Chen

full_name: David Chen

family: Reising

full_name: Albert Reising

given: Albert

family: Marker

full_name: Mahtab Marker

given: Mahtab

family: Shi

full_name: Jiayuan Shi

given: Jiayuan

family: Xu

full_name: Jianing Xu

given: Jianing

family: Ostrovnaya

full_name: Irina Ostrovnaya

given: Irina

family: Seshan

full_name: Venkatraman Seshan

given: Venkatraman

family: Redzematovic

full_name: Almedina Redzematovic

given: Almedina

full_name: Ying-Bei Chen

given: Ying-Bei

family: Patel

full_name: Parul Patel

given: Parul

family: Han

full_name: Xia Han

given: Xia

family: Hsieh

full_name: James J Hsieh

given: James J

family: Hakimi

full_name: A. Ari Hakimi

given: A. Ari

family: Motzer

full_name: Robert J. Motzer

given: Robert J.

journal_name: Clinical Cancer Research

publisher: American Association for Cancer Research (AACR)

title: PTEN Expression, Not Mutation Status for TSC1, TSC2 or mTOR, Correlates With Outcome on Everolimus in Patients With Renal Cell Carcinoma Treated on RECORD-3

ReferenceCitation: Knox JJ, Barrios CH, Kim TM, Cosgriff T, Srimuninnimit V, Pittman K, Sabbatini R, Rha SY, Flaig TW, Page RD, Beck JT, Cheung F, Yadav S, Patel P, Geoffrois L, Niolat J, Berkowitz N, Marker M, Chen D, Motzer RJ. Final overall survival analysis for the phase II RECORD-3 study of first-line everolimus followed by sunitinib versus first-line sunitinib followed by everolimus in metastatic RCC. Ann Oncol. 2017 Jun 1;28(6):1339-1345. doi: 10.1093/annonc/mdx075. Erratum in: Ann Oncol. 2018 Nov 1;29(11):2269.

family: Knox

full_name: J.J. Knox

family: Barrios

full_name: C.H. Barrios

full_name: T.M. Kim

family: Cosgriff

full_name: T. Cosgriff

given: T.

family: Srimuninnimit

full_name: V. Srimuninnimit

given: V.

family: Pittman

full_name: K. Pittman

given: K.

family: Sabbatini

full_name: R. Sabbatini

given: R.

family: Rha

full_name: S.Y. Rha

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

repository_institution: Yonsei University Medical Library - YUHSpace

ReferenceCitation: Motzer RJ, Barrios CH, Kim TM, Falcon S, Cosgriff T, Harker WG, Srimuninnimit V, Pittman K, Sabbatini R, Rha SY, Flaig TW, Page R, Bavbek S, Beck JT, Patel P, Cheung FY, Yadav S, Schiff EM, Wang X, Niolat J, Sellami D, Anak O, Knox JJ. Phase II randomized trial comparing sequential first-line everolimus and second-line sunitinib versus first-line sunitinib and second-line everolimus in patients with metastatic renal cell carcinoma. J Clin Oncol. 2014 Sep 1;32(25):2765-72. doi: 10.1200/JCO.2013.54.6911. Epub 2014 Jul 21.

name: Robert J. Motzer, Memorial Sloan-Kettering Cancer Center, New York, NY; Carlos H. Barrios, PUCRS School of Medicine, Porto Alegre, Brazil; Tae Min Kim, Seoul National University Hospital; and Sun Young Rha, Severance Hospital, Yonsei Cancer Center, Seoul, Korea; Silvia Falcon, Hospital Nacional Edgardo Rebagliati Martins, Lima, Peru; Thomas Cosgriff, Hematology and Oncology Specialists, Metairie, LA; Graydon Harker, Utah Cancer Specialists, Salt Lake City, UT; Vichien Srimuninnimit, Siriraj Hospital,...

publisher: American Society of Clinical Oncology (ASCO)

title: Phase II Randomized Trial Comparing Sequential First-Line Everolimus and Second-Line Sunitinib Versus First-Line Sunitinib and Second-Line Everolimus in Patients With Metastatic Renal Cell Carcinoma

location_country:
Italy
Brazil
United States
Peru
Hong Kong
Mexico
Netherlands
Germany
France
Thailand
Argentina
Australia
Spain
Turkey
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)

location_facility: Billings Clinic Dept of Billings Clinic(2)

location_facility: University of Oklahoma Health Sciences Center Dept of OHSC

location_facility: The West Clinic Dept. of the West Clinic

location_facility: Memorial Sloan Kettering Cancer Center Dept. of MSKCC

location_facility: St. Luke's Hospital and Health Network St Luke's Hospital (2)

location_facility: SUNY - Upstate Medical University Div. of Hematology-Oncology

location_facility: University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.

location_facility: Weinberg Cancer Institute at Franklin Square Hospital

location_facility: University of North Carolina Dept. of LinbergerCancerCtr(3)

location_facility: Hackensack University Medical Center DeptofHackensackUniv.MedCtr.

location_facility: Georgia Health Sciences University Dept. of MCG

location_facility: Crescent City Research Consortium, LLC SC

location_facility: MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando

location_facility: University of California at Los Angeles Dept. of UCLA (3)

location_facility: Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)

location_facility: University of Colorado Dept. of Anschutz Cancer (2)

location_facility: University Cancer & Blood Center, LLC Dept of NE GCC (2)

location_facility: Highlands Oncology Group HighlandsOncGrp-Bentonville(2)

location_facility: VA Maryland Health Care Dept.of GreenbaumCancerCent(7)

location_facility: Loyola University Medical Center /Cardinal Bernardin Cancer Cardinal Bernardin Cancer (3)

location_facility: Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Ctr (2

location_facility: East Texas Medical Center Cancer Institute

location_facility: University of Alabama at Birmingham/ Kirklin Clinic Comprehensive CancerCenter (1)

location_facility: University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (5)

location_facility: NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Dept.ofNorthwesternMemHospital

title: An Open-label, Multicenter Phase II Study to Compare the Efficacy and Safety of RAD001 as First-line Followed by Second-line Sunitinib Versus Sunitinib as First-line Followed by Second-line RAD001 in the Treatment of Patients With Metastatic Renal Cell Carcinoma.

summary: This study assessed the efficacy and safety of first-line RAD001 followed by second-line sunitinib versus the opposite sequence: first-line sunitinib followed by second-line RAD001 for the treatment of patients with MRCC.


ReferenceCitation: Hu MI, Glezerman I, Leboulleux S, Insogna K, Gucalp R, Misiorowski W, Yu B, Ying W, Jain RK. Denosumab for patients with persistent or relapsed hypercalcemia of malignancy despite recent bisphosphonate treatment. J Natl Cancer Inst. 2013 Sep 18;105(18):1417-20. doi: 10.1093/jnci/djt225. Epub 2013 Aug 29.

family: Hu

full_name: M. I. Hu

given: M. I.

family: Glezerman

full_name: I. Glezerman

given: I.

family: Leboulleux

full_name: S. Leboulleux

given: S.

family: Insogna

full_name: K. Insogna

family: Gucalp

full_name: R. Gucalp

family: Misiorowski

full_name: W. Misiorowski

given: W.

family: Yu

full_name: B. Yu

given: B.

family: Ying

full_name: W. Ying

family: Jain

full_name: R. K. Jain

given: R. K.

journal_name: JNCI Journal of the National Cancer Institute

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Denosumab for Patients With Persistent or Relapsed Hypercalcemia of Malignancy Despite Recent Bisphosphonate Treatment

location_country:
Italy
France
Poland
United States
Canada

title: A Single-arm, Multicenter, Proof-of-concept Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium Despite Recent Treatment With IV Bisphosphonates

summary: The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering corrected serum calcium </= 11.5 mg/dL (2.9 millimoles /L) by day 10.


ReferenceCitation: Ruperto N, Brunner HI, Quartier P, Constantin T, Wulffraat NM, Horneff G, Kasapcopur O, Schneider R, Anton J, Barash J, Berner R, Corona F, Cuttica R, Fouillet-Desjonqueres M, Fischbach M, Foster HE, Foell D, Radominski SC, Ramanan AV, Trauzeddel R, Unsal E, Levy J, Vritzali E, Martini A, Lovell DJ; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials. Ann Rheum Dis. 2018 Dec;77(12):1710-1719. doi: 10.1136/annrheumdis-2018-213150. Epub 2018 Sep 29.

family: Ruperto

full_name: Nicolino Ruperto

given: Nicolino

family: Brunner

full_name: Hermine I Brunner

given: Hermine I

family: Quartier

full_name: Pierre Quartier

given: Pierre

family: Constantin

full_name: Tamàs Constantin

given: Tamàs

family: Wulffraat

full_name: Nico M Wulffraat

given: Nico M

family: Horneff

full_name: Gerd Horneff

given: Gerd

family: Kasapcopur

full_name: Ozgur Kasapcopur

given: Ozgur

family: Schneider

full_name: Rayfel Schneider

given: Rayfel

family: Anton

full_name: Jordi Anton

given: Jordi

family: Barash

full_name: Judith Barash

given: Judith

family: Berner

full_name: Reinhard Berner

given: Reinhard

family: Corona

full_name: Fabrizia Corona

given: Fabrizia

family: Cuttica

full_name: Ruben Cuttica

given: Ruben

family: Fouillet-desjonqueres

full_name: Marine Fouillet-desjonqueres

given: Marine

family: Fischbach

full_name: Michel Fischbach

given: Michel

family: Foster

full_name: Helen E Foster

given: Helen E

family: Foell

full_name: Dirk Foell

given: Dirk

family: Radominski

full_name: Sebastião C Radominski

given: Sebastião C

family: Ramanan

full_name: Athimalaipet V Ramanan

given: Athimalaipet V

family: Trauzeddel

full_name: Ralf Trauzeddel

given: Ralf

family: Unsal

full_name: Erbil Unsal

given: Erbil

family: Levy

full_name: Jérémy Levy

given: Jérémy

family: Vritzali

full_name: Eleni Vritzali

given: Eleni

family: Martini

full_name: Alberto Martini

given: Alberto

family: Lovell

full_name: Daniel J Lovell

given: Daniel J

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

repository_institution: University of Bristol - Bristol Research

repository_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Grom AA, Ilowite NT, Pascual V, Brunner HI, Martini A, Lovell D, Ruperto N; Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group, Leon K, Lheritier K, Abrams K. Rate and Clinical Presentation of Macrophage Activation Syndrome in Patients With Systemic Juvenile Idiopathic Arthritis Treated With Canakinumab. Arthritis Rheumatol. 2016 Jan;68(1):218-28. doi: 10.1002/art.39407.

name: Cincinnati Children's Hospital Medical Center; Cincinnati Ohio

name: Children's Hospital at Montefiore; Bronx New York

name: Baylor Institute for Immunology Research; Dallas Texas

name: Università di Genova and Istituto Giannina Gaslini; Genoa Italy

name: Novartis Pharmaceuticals Corporation; East Hanover New Jersey

name: for the Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group

location_country:
Peru
Greece
Belgium
Russian Federation
France
Poland
Argentina
Canada
Sweden
Switzerland
Netherlands
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
Spain
Turkey

title: An Open-label Extension Study of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations Who Participated in Studies ACZ885G2301 and ACZ885G2305; and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever

summary: This open-label extension study will permit patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab treatment-naïve patients with active SJIA with and without fever to be retreated with 4 mg/kg s.c. every 4 weeks and assessed for continued efficacy and safety until discontinuation or when study CACZ885G2402 is in place at their study center or around March 2013, whichever occurs first. Patients who are steroid-free will be able to taper their canakinumab dose to 2 mg/kg s.c. every 4 weeks.


title: A Randomized, Double-blind, Placebo Controlled, Withdrawal Study of Flare Prevention of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations

acronym: β-SPECIFIC 2

summary: This two-part study assessed the sustained efficacy of canakinumab in the double-blind Part II and the ability to taper steroids in the open label Part I.

family: Ruperto

full_name: Nicolino Ruperto

given: Nicolino

family: Brunner

full_name: Hermine I Brunner

given: Hermine I

family: Quartier

full_name: Pierre Quartier

given: Pierre

family: Constantin

full_name: Tamàs Constantin

given: Tamàs

family: Wulffraat

full_name: Nico M Wulffraat

given: Nico M

family: Horneff

full_name: Gerd Horneff

given: Gerd

family: Kasapcopur

full_name: Ozgur Kasapcopur

given: Ozgur

family: Schneider

full_name: Rayfel Schneider

given: Rayfel

family: Anton

full_name: Jordi Anton

given: Jordi

repositories_institution: Newcastle Univesity - Newcastle University ePrints

repositories_institution: University of Bristol - Bristol Research

title: Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials

ReferenceCitation: Brachat AH, Grom AA, Wulffraat N, Brunner HI, Quartier P, Brik R, McCann L, Ozdogan H, Rutkowska-Sak L, Schneider R, Gerloni V, Harel L, Terreri M, Houghton K, Joos R, Kingsbury D, Lopez-Benitez JM, Bek S, Schumacher M, Valentin MA, Gram H, Abrams K, Martini A, Lovell DJ, Nirmala NR, Ruperto N; Pediatric Rheumatology International Trials Organization (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Early changes in gene expression and inflammatory proteins in systemic juvenile idiopathic arthritis patients on canakinumab therapy. Arthritis Res Ther. 2017 Jan 23;19(1):13. doi: 10.1186/s13075-016-1212-x.

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

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

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

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

title: Rate and Clinical Presentation of Macrophage Activation Syndrome in Patients With Systemic Juvenile Idiopathic Arthritis Treated With Canakinumab

ReferenceCitation: Ruperto N, Brunner HI, Quartier P, Constantin T, Wulffraat N, Horneff G, Brik R, McCann L, Kasapcopur O, Rutkowska-Sak L, Schneider R, Berkun Y, Calvo I, Erguven M, Goffin L, Hofer M, Kallinich T, Oliveira SK, Uziel Y, Viola S, Nistala K, Wouters C, Cimaz R, Ferrandiz MA, Flato B, Gamir ML, Kone-Paut I, Grom A, Magnusson B, Ozen S, Sztajnbok F, Lheritier K, Abrams K, Kim D, Martini A, Lovell DJ; PRINTO; PRCSG. Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis. N Engl J Med. 2012 Dec 20;367(25):2396-406. doi: 10.1056/NEJMoa1205099.

title: Two Randomized Trials of Canakinumab in Systemic Juvenile Idiopathic Arthritis

location_country:
Italy
United States
Brazil
Peru
South Africa
Sweden
Switzerland
Netherlands
Germany
France
Poland
Israel
Norway
Hungary
Belgium
Argentina
Spain
Turkey
Canada

location_facility: Arkansas Children's Hospital Research Inst

location_facility: New England Medical Center - Department of Allergy


intervention_type: Dietary Supplement

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Mexico
Germany
Croatia
Czechia
France
Greece
Norway
Spain
Denmark
United States
Canada

acronym: MOVE

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.

ipd_sharing: Yes

type: Other Identifier

title: Comparison of the Effects of Teriparatide With Those of Risedronate on Lumbar Spine BMD (Bone Mineral Density) in Men and Postmenopausal Women With Low Bone Mass and a Recent Pertrochanteric Hip Fracture

summary: This study will evaluate whether teriparatide is superior to the active comparator in the change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal women with low bone mass and a recent pertrochanteric hip fracture.


family: Barash

full_name: Judith Barash

given: Judith

family: Berner

full_name: Reinhard Berner

given: Reinhard

family: Corona

full_name: Fabrizia Corona

given: Fabrizia

family: Cuttica

full_name: Ruben Cuttica

given: Ruben

family: Fouillet-desjonqueres

full_name: Marine Fouillet-desjonqueres

given: Marine

family: Fischbach

full_name: Michel Fischbach

given: Michel

family: Foster

full_name: Helen E Foster

given: Helen E

family: Foell

full_name: Dirk Foell

given: Dirk

family: Radominski

full_name: Sebastião C Radominski

given: Sebastião C

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

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

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

title: Early changes in gene expression and inflammatory proteins in systemic juvenile idiopathic arthritis patients on canakinumab therapy

location_country:
Peru
Greece
Belgium
Denmark
France
Poland
Norway
Argentina
Canada
South Africa
Sweden
Switzerland
Netherlands
Hungary
United States
Germany
United Kingdom
Italy
Brazil
Israel
Spain
Turkey

location_facility: Tufts New England Medical Center-Dept. of Allergy

title: A Randomized, Double-blind, Placebo Controlled, Single-dose Study to Assess the Initial Efficacy of Canakinumab (ACZ885) With Respect to the Adapted ACR Pediatric 30 Criteria in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations

summary: This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30 criteria at Day 15.


title: A Dose-ranging, Randomized, Double-blind , Placebo-controlled Study of the Effect of RO5313534, Used as add-on Therapy to Donepezil, on Cognitive Function in Patients With Mild to Moderate Symptoms of Alzheimer's Disease

summary: This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534 1mg, 5mg or 15mg po daily) with background therapy of donepezil (5mg or 10mg).The anticipated time on study treatment is 6 months, and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
Mexico
Germany
France
Poland
Slovakia
Romania
Argentina
Australia
Spain
Canada
United Kingdom


ReferenceCitation: McMeekin S, Dizon D, Barter J, Scambia G, Manzyuk L, Lisyanskaya A, Oaknin A, Ringuette S, Mukhopadhyay P, Rosenberg J, Vergote I. Phase III randomized trial of second-line ixabepilone versus paclitaxel or doxorubicin in women with advanced endometrial cancer. Gynecol Oncol. 2015 Jul;138(1):18-23. doi: 10.1016/j.ygyno.2015.04.026. Epub 2015 Apr 26.

family: McMeekin

full_name: Scott McMeekin

given: Scott

family: Dizon

full_name: Don Dizon

given: Don

family: Barter

full_name: James Barter

given: James

family: Scambia

full_name: Giovanni Scambia

given: Giovanni

family: Manzyuk

full_name: Lyudmila Manzyuk

given: Lyudmila

family: Lisyanskaya

full_name: Alla Lisyanskaya

given: Alla

family: Oaknin

full_name: Ana Oaknin

given: Ana

family: Ringuette

full_name: Sarah Ringuette

given: Sarah

family: Mukhopadhyay

full_name: Pralay Mukhopadhyay

given: Pralay

family: Rosenberg

full_name: Julie Rosenberg

given: Julie

family: Vergote

full_name: Ignace Vergote

given: Ignace

journal_name: Gynecologic Oncology

status: Terminated

lead_sponsor: R-Pharm

location_country:
Italy
Brazil
Peru
Sweden
United Kingdom
Mexico
Spain
France
Greece
Norway
Hungary
Belgium
Argentina
Australia
Russian Federation
Denmark
United States
Czech Republic
Canada

location_facility: Magee-Womens Hospital Of Upmc Laboratory

location_facility: St. Vincent Hospital And Health Care Center, Inc.

location_facility: Hematology And Oncology Specialists, Llc

location_facility: Tennessee Gynecologic Oncology Group, Llc

location_facility: Peggy And Charles Stephenson Oklahoma Cancer Center

location_facility: Pennsylvania Oncology Hematology Associates

title: A Phase III, Open Label, Randomized, 2 Arm Study of Ixabepilone Administered Every 21 Days Versus Paclitaxel or Doxorubicin Administered Every 21 Days in Women With Advanced Endometrial Cancer Who Have Previously Been Treated With Chemotherapy

summary: The primary purpose of this study is to investigate whether administration of ixabepilone results in superior outcome as assessed by overall survival compared with that achieved with standard chemotherapy (paclitaxel or doxorubicin) in women with advanced endometrial cancer that has progressed following first-line chemotherapy.

status_simplified: Unknown


title: Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis

summary: To look at the ability of LY2127399 to reduce magnetic resonance imaging (MRI) lesions at 12, 16, 20, and 24 weeks compared to placebo.

location_country:
United States
Serbia
France
Czechia
Bulgaria
Israel
Poland
Romania
Hungary
Russian Federation
Slovakia
Germany
Ukraine


title: A 104 Week, Randomized, Double Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy of Aliskiren on the Progression of Atherosclerosis in Patients With Coronary Artery Disease When Added to Optimal Background Therapy

acronym: AQUARIUS

summary: The study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the pre-hypertensive range.

ReferenceCitation: Puri R, Nissen SE, Menon V, Shao M, Hsu A, Bakris GL, Kastelein JJ, Williams B, Armbrecht J, Brunel P, Kataoka Y, Nicholls SJ. Effects of aliskiren in diabetic and non-diabetic patients with coronary artery disease: Insights from AQUARIUS. Atherosclerosis. 2015 Dec;243(2):553-9. doi: 10.1016/j.atherosclerosis.2015.10.019. Epub 2015 Oct 20.

family: Puri

full_name: Rishi Puri

given: Rishi

family: Nissen

full_name: Steven E. Nissen

given: Steven E.

family: Menon

full_name: Venu Menon

given: Venu

family: Shao

full_name: Mingyuan Shao

given: Mingyuan

family: Hsu

full_name: Amy Hsu

given: Amy

family: Bakris

full_name: George L. Bakris

given: George L.

family: Kastelein

full_name: John J.P. Kastelein

given: John J.P.

family: Williams

full_name: Bryan Williams

given: Bryan

family: Armbrecht

full_name: Juergen Armbrecht

given: Juergen

family: Brunel

full_name: Patrick Brunel

given: Patrick

family: Kataoka

full_name: Yu Kataoka

given: Yu

family: Nicholls

full_name: Stephen J. Nicholls

given: Stephen J.

journal_name: Atherosclerosis

ReferenceCitation: Nicholls SJ, Bakris GL, Kastelein JJ, Menon V, Williams B, Armbrecht J, Brunel P, Nicolaides M, Hsu A, Hu B, Fang H, Puri R, Uno K, Kataoka Y, Bash D, Nissen SE. Effect of aliskiren on progression of coronary disease in patients with prehypertension: the AQUARIUS randomized clinical trial. JAMA. 2013 Sep 18;310(11):1135-44. doi: 10.1001/jama.2013.277169.

full_name: John J. P. Kastelein

given: John J. P.

family: Nicolaides

full_name: Maria Nicolaides

given: Maria

title: Effect of Aliskiren on Progression of Coronary Disease in Patients With Prehypertension

location_country:
Italy
United States
Germany
France
Poland
Hungary
Belgium
Argentina
Australia
Spain
Canada


lead_sponsor: Eisai Inc.

location_country:
Italy
South Africa
Sweden
India
Serbia
Switzerland
France
Poland
Greece
Slovakia
Montenegro
Hungary
Australia
Russian Federation
Spain
Denmark
Germany
United Kingdom
Korea, Republic of
Taiwan

title: A Randomized, Double-Blind Extension Study To Assess The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures

summary: The purpose of this study is to assess the long-term safety and tolerability and to explore the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly diagnosed partial seizures.


ReferenceType: result

ReferenceCitation: Caplin ME, Pavel M, Ćwikła JB, Phan AT, Raderer M, Sedláčková E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Gomez-Panzani E, Ruszniewski P; CLARINET Investigators. Anti-tumour effects of lanreotide for pancreatic and intestinal neuroendocrine tumours: the CLARINET open-label extension study. Endocr Relat Cancer. 2016 Mar;23(3):191-9. doi: 10.1530/ERC-15-0490. Epub 2016 Jan 7.

family: Caplin

full_name: Martyn E Caplin

given: Martyn E

family: Pavel

full_name: Marianne Pavel

given: Marianne

family: Ćwikła

full_name: Jarosław B Ćwikła

given: Jarosław B

family: Phan

full_name: Alexandria T Phan

given: Alexandria T

family: Raderer

full_name: Markus Raderer

given: Markus

family: Sedláčková

full_name: Eva Sedláčková

given: Eva

family: Cadiot

full_name: Guillaume Cadiot

given: Guillaume

family: Wolin

full_name: Edward M Wolin

given: Edward M

family: Capdevila

full_name: Jaume Capdevila

given: Jaume

family: Wall

full_name: Lucy Wall

given: Lucy

family: Rindi

full_name: Guido Rindi

given: Guido

family: Langley

full_name: Alison Langley

given: Alison

family: Martinez

full_name: Séverine Martinez

given: Séverine

family: Gomez-Panzani

full_name: Edda Gomez-Panzani

given: Edda

family: Ruszniewski

full_name: Philippe Ruszniewski

given: Philippe

journal_name: Endocrine-Related Cancer

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

publisher: Bioscientifica

publisher_dissemination: Bioscientifica

publisher_group: Bioscientifica

publisher_normalized: Bioscientifica

ReferenceCitation: Caplin ME, Pavel M, Phan AT, Ćwikła JB, Sedláčková E, Thanh XT, Wolin EM, Ruszniewski P; CLARINET Investigators. Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study. Endocrine. 2021 Feb;71(2):502-513. doi: 10.1007/s12020-020-02475-2. Epub 2020 Oct 14.

full_name: Martyn E. Caplin

given: Martyn E.

repository_institution: University College London - UCL Discovery

location_country:
Italy
France
Czechia
Poland
Slovakia
Belgium
Spain
United States
United Kingdom

location_facility: Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny

title: Open Label Extension Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour

summary: The primary purpose of this extension study was to assess the long term safety of patients with nonfunctioning enteropancreatic neuroendocrine tumour (NET), who were treated with open label lanreotide Autogel (120 mg every 28 days) and who participated in a previous study, 2-55-52030-726 (NCT00353496).


title: A Pivotal Phase II, Multicenter, Single-arm, Two-cohort Trial Evaluating the Efficacy and Safety of GDC-0449 in Patients With Advanced Basal Cell Carcinoma

summary: This was a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma. All patients received vismodegib until evidence of progression, intolerable toxicities most probably attributable to vismodegib, or withdrawal from the study.

ReferenceCitation: Sekulic A, Migden MR, Basset-Seguin N, Garbe C, Gesierich A, Lao CD, Miller C, Mortier L, Murrell DF, Hamid O, Quevedo JF, Hou J, McKenna E, Dimier N, Williams S, Schadendorf D, Hauschild A; ERIVANCE BCC Investigators. Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study. BMC Cancer. 2017 May 16;17(1):332. doi: 10.1186/s12885-017-3286-5. Erratum in: BMC Cancer. 2019 Apr 18;19(1):366.

family: Sekulic

full_name: Aleksandar Sekulic

given: Aleksandar

family: Migden

full_name: Michael R. Migden

given: Michael R.

family: Basset-Seguin

full_name: Nicole Basset-Seguin

given: Nicole

family: Garbe

full_name: Claus Garbe

given: Claus

family: Gesierich

full_name: Anja Gesierich

given: Anja

family: Lao

full_name: Christopher D. Lao

given: Christopher D.

family: Miller

full_name: Chris Miller

given: Chris

family: Mortier

full_name: Laurent Mortier

given: Laurent

family: Murrell

full_name: Dedee F. Murrell

given: Dedee F.

family: Hamid

full_name: Omid Hamid

given: Omid

family: Quevedo

full_name: Jorge F. Quevedo

given: Jorge F.

family: Hou

full_name: Jeannie Hou

given: Jeannie

family: McKenna

full_name: Edward McKenna

given: Edward

family: Dimier

full_name: Natalie Dimier

given: Natalie

family: Williams

full_name: Sarah Williams

given: Sarah

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Hauschild

full_name: Axel Hauschild

given: Axel

currency_apc_doaj: GBP

journal_name: BMC Cancer

oa_colors: green gold

evidence: oa journal (via doaj)

ReferenceCitation: Chang AL, Arron ST, Migden MR, Solomon JA, Yoo S, Day BM, McKenna EF, Sekulic A. Safety and efficacy of vismodegib in patients with basal cell carcinoma nevus syndrome: pooled analysis of two trials. Orphanet J Rare Dis. 2016 Sep 1;11(1):120. doi: 10.1186/s13023-016-0506-z.

repository_institution: University of California - eScholarship University of California

ReferenceCitation: Sekulic A, Migden MR, Oro AE, Dirix L, Lewis KD, Hainsworth JD, Solomon JA, Yoo S, Arron ST, Friedlander PA, Marmur E, Rudin CM, Chang AL, Low JA, Mackey HM, Yauch RL, Graham RA, Reddy JC, Hauschild A. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med. 2012 Jun 7;366(23):2171-9. doi: 10.1056/NEJMoa1113713.

title: Efficacy and Safety of Vismodegib in Advanced Basal-Cell Carcinoma

location_country:
Germany
France
Belgium
Australia
United States
United Kingdom


title: Phase IIB, Multicenter, Randomized, Open-Label Trial Of CPX-351 (Cytarabine : Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adult Patients ≤ 65 Years Old With AML In First Relapse Following An Initial CR > 1 Month Duration

summary:
The study investigates if CPX-351 will be a) more effective than the standard intensive salvage AML treatment and b) more tolerable than the standard intensive salvage treatment regimens.

The study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.

lead_sponsor: Jazz Pharmaceuticals

location_country:
United States
Canada
France
Poland

location_facility: University of Louisville Brown Cancer Center

location_facility: Blumenthal Cancer Center/Mecklenburg Medical Group

location_facility: Maine General Medical Center Harold Alfond Center for Cancer Care

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika

location_facility: Service des Maladies du Sang CHU de Lille, Hopital Claude Huriez

location_facility: Service d'Hématologie CHU Toulouse-Hôpital Purpan

location_facility: The Cancer Center, Hackensack University Medical Center

location_facility: Oncology and Hematology at Lehigh Valley

location_facility: Northwestern University Robert H. Lurie Comprehensive Cancer Center

location_facility: Vancouver General Hospital/ British Columbia Cancer Agency

location_facility: Service d'Hématologie et Médecine Interne CHU de Nancy-Hôpital de Brabois

location_facility: North Shore LIJ Center for Advanced Medicine Monter Cancer Center

location_facility: Texas Tech University Health Sciences Center

location_facility: University of Chicago Medical Center Section of Hematology/Oncology

location_facility: Service des Maladies du Sang Hopital Haut-Leveque

location_facility: Cancer Therapy and Research Center at The University of TX Health Science Center


title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma

summary: This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI

lead_sponsor: NantCell, Inc.

location_country:
Italy
India
Hong Kong
France
Poland
Singapore
Hungary
Russian Federation
Spain
United States

intervention_type: Other


title: Safety, Antiviral Activity, and Pharmacokinetics of Multiple Rising Oral Doses of BI 201335 NA in Treatment-naïve Patients With Chronic Hepatitis C Infection for 14 Days Monotherapy Followed by Combination With Pegylated Interferon and Ribavirin for an Additional 14 Days (Double-blind, Placebo Controlled), and in Treatment-experienced Patients With Chronic Hepatitis C Infection for 28 Days as Combination Therapy With Pegylated Interferon and Ribavirin (Open-label)

summary:
This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced patients.

A secondary objective is to investigate antiviral activity, potential drug-drug interactions and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for treatment-naïve patients.

ReferenceCitation: Berger KL, Lagacé L, Triki I, Cartier M, Marquis M, Lawetz C, Bethell R, Scherer J, Kukolj G. Viral resistance in hepatitis C virus genotype 1-infected patients receiving the NS3 protease inhibitor Faldaprevir (BI 201335) in a phase 1b multiple-rising-dose study. Antimicrob Agents Chemother. 2013 Oct;57(10):4928-36. doi: 10.1128/AAC.00822-13. Epub 2013 Jul 22.

family: Berger

full_name: Kristi L. Berger

given: Kristi L.

family: Lagacé

full_name: Lisette Lagacé

given: Lisette

family: Triki

full_name: Ibtissem Triki

given: Ibtissem

family: Cartier

full_name: Mireille Cartier

given: Mireille

family: Marquis

full_name: Martin Marquis

given: Martin

family: Lawetz

full_name: Carol Lawetz

given: Carol

family: Bethell

full_name: Richard Bethell

given: Richard

family: Scherer

full_name: Joseph Scherer

given: Joseph

family: Kukolj

full_name: George Kukolj

given: George

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: Viral Resistance in Hepatitis C Virus Genotype 1-Infected Patients Receiving the NS3 Protease Inhibitor Faldaprevir (BI 201335) in a Phase 1b Multiple-Rising-Dose Study

ReferenceCitation: Manns MP, Bourlière M, Benhamou Y, Pol S, Bonacini M, Trepo C, Wright D, Berg T, Calleja JL, White PW, Stern JO, Steinmann G, Yong CL, Kukolj G, Scherer J, Boecher WO. Potency, safety, and pharmacokinetics of the NS3/4A protease inhibitor BI201335 in patients with chronic HCV genotype-1 infection. J Hepatol. 2011 Jun;54(6):1114-22. doi: 10.1016/j.jhep.2010.08.040. Epub 2010 Nov 11.

family: Manns

full_name: Michael P. Manns

given: Michael P.

family: Bourlière

full_name: Marc Bourlière

given: Marc

family: Benhamou

full_name: Yves Benhamou

given: Yves

family: Pol

full_name: Stanislas Pol

given: Stanislas

family: Bonacini

full_name: Maurizio Bonacini

given: Maurizio

family: Trepo

full_name: Christian Trepo

given: Christian

family: Wright

full_name: David Wright

given: David

family: Berg

location_facility: 1220.2.3304A Boehringer Ingelheim Investigational Site

location_facility: 1220.2.12 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.14 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.49005 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.3302A Boehringer Ingelheim Investigational Site

location_facility: 1220.2.3303A Boehringer Ingelheim Investigational Site

location_facility: 1220.2.49003 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.15 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.34001 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.3301A Boehringer Ingelheim Investigational Site

location_facility: 1220.2.17 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.49006 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.49004 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.10 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.49002 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.11 Boehringer Ingelheim Investigational Site


title: A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis.

summary: The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2021 Mar 6. pii: S1542-3565(21)00222-6. doi: 10.1016/j.cgh.2021.02.043. [Epub ahead of print]

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Peyrin-Biroulet

full_name: Laurent Peyrin-Biroulet

given: Laurent

family: Sharara

full_name: Ala I. Sharara

given: Ala I.

family: Su

full_name: Chinyu Su

given: Chinyu

family: Modesto

full_name: Irene Modesto

given: Irene

family: Mundayat

full_name: Rajiv Mundayat

given: Rajiv

family: Gunay

full_name: L. Mert Gunay

given: L. Mert

family: Salese

full_name: Leonardo Salese

given: Leonardo

family: Sands

full_name: Bruce E. Sands

given: Bruce E.

journal_name: Clinical Gastroenterology and Hepatology

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Vong C, Martin SW, Deng C, Xie R, Ito K, Su C, Sandborn WJ, Mukherjee A. Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis. Clin Pharmacol Drug Dev. 2021 Mar;10(3):229-240. doi: 10.1002/cpdd.899. Epub 2021 Jan 29.

family: Vong

full_name: Camille Vong

given: Camille

family: Martin

full_name: Steven W. Martin

given: Steven W.

name: Beijing Linking Truth Technology Co. Ltd  Shanghai China

family: Deng

full_name: Chenhui Deng

given: Chenhui

family: Xie

full_name: Rujia Xie

given: Rujia

family: Ito

full_name: Kaori Ito

given: Kaori

name: Pfizer Inc  Collegeville Pennsylvania USA

name: Division of Gastroenterology University of California, San Diego  La Jolla California USA

family: Mukherjee

full_name: Arnab Mukherjee

given: Arnab

journal_name: Clinical Pharmacology in Drug Development

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Quirk D, Wang W, Nduaka CI, Mukherjee A, Su C, Sands BE. Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Oct 27. pii: S1542-3565(20)31496-8. doi: 10.1016/j.cgh.2020.10.038. [Epub ahead of print]

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum in: Dig Dis Sci. 2020 Oct 10;:.

ReferenceCitation: Sandborn WJ, Panés J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.

name: Division of Gastroenterology; University of California, San Diego; La Jolla California

name: Hospital Clínic de Barcelona; IDIBAPS, CIBERehd; Barcelona Spain

name: Dr. Henry D. Janowitz Division of Gastroenterology; Icahn School of Medicine at Mount Sinai; New York New York

name: Medical University of Vienna; Vienna Austria

name: Division of Gastroenterology; IBD Center; Humanitas University; Rozzano Milan Italy

ReferenceCitation: Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.

ReferenceCitation: Sandborn WJ, Panés J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.

ReferenceCitation: Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.

name: Oregon Health & Science University, Portland, Oregon

name: Cedars-Sinai Medical Center, Los Angeles, California

name: Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium

name: Center for Gastrointestinal Biology and Disease, University of North Carolina, Chapel Hill, North Carolina

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

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

ReferenceCitation: Sandborn WJ, Panés J, Zhang H, Yu D, Niezychowski W, Su C. Correlation Between Concentrations of Fecal Calprotectin and Outcomes of Patients With Ulcerative Colitis in a Phase 2 Trial. Gastroenterology. 2016 Jan;150(1):96-102. doi: 10.1053/j.gastro.2015.09.001. Epub 2015 Sep 12.

ReferenceCitation: Panés J, Su C, Bushmakin AG, Cappelleri JC, Mamolo C, Healey P. Randomized trial of tofacitinib in active ulcerative colitis: analysis of efficacy based on patient-reported outcomes. BMC Gastroenterol. 2015 Feb 5;15:14. doi: 10.1186/s12876-015-0239-9.

ReferenceCitation: Sandborn WJ, Ghosh S, Panes J, Vranic I, Su C, Rousell S, Niezychowski W; Study A3921063 Investigators. Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis. N Engl J Med. 2012 Aug 16;367(7):616-24. doi: 10.1056/NEJMoa1112168.

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

title: Tofacitinib, an Oral Janus Kinase Inhibitor, in Active Ulcerative Colitis

location_country:
Italy
Brazil
Chile
South Africa
Sweden
United Kingdom
Mexico
Netherlands
France
Poland
Israel
Slovakia
Hungary
Belgium
Spain
Denmark
Czech Republic


title: A Single-Blind, Multicenter, Placebo-Controlled, Sequential Design Study Evaluating the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram

summary: The purpose of this study is to assess the potential effects of trabectedin on the QT/QTc interval duration measured by electrocardiograms (ECGs) in participants with advanced solid tumor malignancies when administered at a therapeutic dose.

ReferenceCitation: Thertulien R, Manikhas GM, Dirix LY, Vermorken JB, Park K, Jain MM, Jiao JJ, Natarajan J, Parekh T, Zannikos P, Staddon AP. Effect of trabectedin on the QT interval in patients with advanced solid tumor malignancies. Cancer Chemother Pharmacol. 2012 Feb;69(2):341-50. doi: 10.1007/s00280-011-1697-6. Epub 2011 Jul 8.

family: Thertulien

full_name: R. Thertulien

given: R.

family: Manikhas

full_name: G. M. Manikhas

given: G. M.

family: Dirix

full_name: L. Y. Dirix

given: L. Y.

family: Vermorken

full_name: J. B. Vermorken

given: J. B.

family: Park

full_name: K. Park

given: K.

family: Jain

full_name: M. M. Jain

given: M. M.

family: Jiao

full_name: J. J. Jiao

given: J. J.

family: Natarajan

full_name: J. Natarajan

given: J.

family: Parekh

full_name: T. Parekh

given: T.

family: Zannikos

full_name: P. Zannikos

given: P.

family: Staddon

full_name: A. P. Staddon

given: A. P.

journal_name: Cancer Chemotherapy and Pharmacology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

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

location_country:
India
France
Belgium
Russian Federation
Spain
United States
Korea, Republic of


design_allocation: Non-Randomized

location_country:
Italy
France
Poland
Australia
United States
United Kingdom

title: Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology

summary: The purpose of this study is to determine the safety and efficacy of oral lenvatinib in participants with medullary thyroid cancer (MTC) or radioiodine (131 I)-refractory/resistant differentiated thyroid cancer (DTC), unresectable differentiated thyroid cancers, stratified by Histology.


ReferenceCitation: Martin M, Bonneterre J, Geyer CE Jr, Ito Y, Ro J, Lang I, Kim SB, Germa C, Vermette J, Wang K, Wang K, Awada A. A phase two randomised trial of neratinib monotherapy versus lapatinib plus capecitabine combination therapy in patients with HER2+ advanced breast cancer. Eur J Cancer. 2013 Dec;49(18):3763-72. doi: 10.1016/j.ejca.2013.07.142. Epub 2013 Aug 15.

full_name: Miguel Martin

given: Miguel

family: Bonneterre

full_name: Jacques Bonneterre

given: Jacques

family: Geyer

full_name: Charles E. Geyer

given: Charles E.

suffix: Jr.

full_name: Yoshinori Ito

given: Yoshinori

family: Ro

full_name: Jungsil Ro

given: Jungsil

family: Lang

full_name: Istvan Lang

given: Istvan

family: Kim

full_name: Sung-Bae Kim

given: Sung-Bae

family: Germa

full_name: Caroline Germa

given: Caroline

family: Vermette

full_name: Jennifer Vermette

given: Jennifer

family: Wang

full_name: Kenneth Wang

given: Kenneth

full_name: Kongming Wang

given: Kongming

family: Awada

full_name: Ahmad Awada

given: Ahmad

journal_name: European Journal of Cancer

lead_sponsor: Puma Biotechnology, Inc.

location_country:
Jordan
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
Croatia
France
Japan
Poland
Thailand
Canada
Slovenia
Korea, Republic of
South Africa
Hong Kong
Switzerland
Bulgaria
Singapore
Hungary
Puerto Rico
Germany
United States
United Kingdom
Italy
Austria
Serbia
Mexico
Czechia
Spain

acronym: Not available

location_facility: Szegedi Tudomanyegyetem Onkoterapias Klinika

location_facility: Hospital Provincial (Reina Sofia) Servicio de Oncologia

location_facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research Department of Medical Oncology

location_facility: Ryazan State Medical University I.P.Pavlov of Federal Agency in Healthcare and Social Development

location_facility: Nationales Centrum fuer Tumorerkrankungen Sektion Gynaekologische Onkologie

location_facility: Medical Oncology Royal Adelaide Hospital

location_facility: GVI Oncology Trial Unit Room 110 Panorama Medical Centre

location_facility: Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

location_facility: Aptium Oncology/Comprehensive Cancer Center at Desert Regional Medical Center

location_facility: Hospital Central de Asturias Servicio de Oncologia, Planta Baja Oeste, Edificio Principal

location_facility: University of Tennessee Cancer Institute

location_facility: Hospital Universitario Miguel Servet Servicio de Oncologia

location_facility: Corporacio Sanitaria Parc Tauli Servicio de Oncologia

location_facility: Hakuaikai Medical Corporation Sagara Hospital

location_facility: Fovarosi Onkormanyzat Szent Janos Korhaza es Eszak-budai Egyesitett Korhazai, Onkologia

location_facility: Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"

location_facility: Johns Hopkins Singapore International Medical Centre

location_facility: Tokyo Metropolitan Cancer&Infectious disease Ctr Komagome Hp

location_facility: Cancer Care Network of South Texas-HOAST

location_facility: Centro Hospitalario de Jaen Servicio de Oncologia

location_facility: Allegheny General Hospital Allegheny Cancer Center

location_facility: UNIMED Medical Institute, Comprehensive Centre for Breast Diseases

location_facility: Department of Clinical Oncology, Tuen Mun Hospital

location_facility: Palm Beach Institute of Hematology & Oncology

location_facility: Hospital Germans Trias i Pujol Servicio de Oncologia

location_facility: Thompson Cancer Survival Center Thompson Oncology Group

location_facility: SIH Oncology Dispensary # 2 Of Department of Public Health

location_facility: Hospital Gregorio Marañon Servicio de Oncologia

location_facility: Division of Medical Oncology, Department of Medicine

location_facility: Cancer Care Specialists Of Central Illinois

location_facility: Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie w Bialymstoku Specjalistyczny Szpital Onkologiczn

location_facility: Institut Gustave ROUSSY Service de Pathologie mammaire

location_facility: Josa Andras Oktatokorhaz / Onkoradiologiai Osztaly

location_facility: Centro Oncologico M.D. Anderson Internacional

location_facility: CHU de Poitiers Service d'oncologie medicale

location_facility: Instituto Valenciano de Oncologia Servicio de Oncologia

location_facility: Interdistrict Dispensary for Oncology Diseases -Internal Unit- Department Oncotherapy and Palliative Care

location_facility: Capitol Comprehensive Cancer Care Clinic

location_facility: The Royal Marsden NHS Foundation Trust & Institute of Cancer Research

location_facility: Oca Hospital / Monterrey International Research Center

location_facility: Centre Hospitalier Affilie Universitaire de Quebec Hopital du St-Sacrement

location_facility: University of Oklahoma Health Sciences Center Dept. of Hematology Oncology

location_facility: Uniwersyteckie Centrum Kliniczne w Gdansku Klinika Onkologii i Radioterapii

location_facility: Kantonsspital Winterthur Medizinische Onkologie

location_facility: Complejo Hospitalario U. de A Coruña Hospital Teresa Herrera Servicio de Oncologia

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Fakultni nemocnice Olomouc Klinika onkologie

location_facility: St. Petersburg State Medical University I.P.Pavlov of Roszdrav

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: MetroHealth Medical Center, Cancer Care Center

location_facility: Russian Oncology Research Centre of RAMS

location_facility: SIH Leningrad Regional Oncology Dispensary

location_facility: Theagenio Anticancer Hospital of Thessaloniki

location_facility: Institut Jules Bordet Unite du Chimiotherapie

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin I Klinische Abteilung für Onkologie

location_facility: Centre Oscar Lambret Departement de senologie

location_facility: Klinicko Bolnicki Centar (KBC) Bezanijska Kosa (Medical Centre ''Bezanijska Kosa'' (MCBK))

location_facility: Yonsei University Health System - Severance Hospital

location_facility: Universitaetsklinikum Hamburg-Eppendorf Klinik und Poliklinik fuer Gynaekologie

location_facility: Szpital Uniwersytecki w Krakowie Oddzial KIiniczny Kliniki Onkologii

location_facility: East Texas Medical Center Cancer Institute, Tyler Hematology Oncology

location_facility: District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD, Dept. of Chemotherapy

location_facility: Hospital San Pedro de Alcantara Servicio de Oncologia

location_facility: The Center for Cancer and Blood Disorders

location_facility: Hospital General Universitario de Alicante Servicio de Oncologia

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Hospital Clinico Universitario de Valencia Servicio de Hematologia y Oncologia

location_facility: Abteilung fuer Onkologie Departement für Innere

location_facility: Owsley Brown Frazier Cancer Center (OBFCC)

location_facility: Istituto Regina Elena, Struttura Complessa Oncologia Medica A

location_facility: Weill Cornell Medical College New York-Presbyterian Hospital Weill, Cornell Breast Center

location_facility: Hospital Mutua de Terrassa Servicio de Oncologia

location_facility: Hospital Universitario Dr. Josep Trueta Servicio de Oncologia

location_facility: Ospedale Misericordia e Dolce c/o UO Oncologia Medica

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Scientific Research Institute of Oncology N.N. Petrov

location_facility: Institute for Oncology Department for Medical Oncology

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Bashkortostan Republic

location_facility: Centrum Onkologii Ziemi Lubelskiej im. SW. Jana z Dukli

title: A Phase 2 Randomized Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine For The Treatment Of ErbB-2 Positive Locally Advanced Or Metastatic Breast Cancer

summary: This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.


title: Effect of LY450139 a y-Secretase Inhibitor, on the Progression of Alzheimer's Disease as Compared With Placebo

summary:
Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta amyloid (β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (γ-secretase) lowers the production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in blood, spinal fluid and brain in animals tested thus far. This study used several different tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some patients. The buildup of amyloid plaques was measured by a brain scan that takes a picture of amyloid plaques in the brain. Other tests measured the overall function of the brain and brain size in some patients. In this trial, patients who initially received placebo (inactive sugar pill) were, at a certain point in the study, switched over to active drug, semagacestat. In other words, all patients could eventually receive active drug. Each patient's participation could last approximately 2 years. Patients taking approved AD medications were permitted to participate in this study and continue taking these medications during the study. All patients who completed this study had the option to continue receiving semagacestat by participating in an open label study.

Preliminary results from this study (LFBC) (and another similar study LFAN [NCT00594568]) showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. LFBC, LFAN and open label LFBF (NCT01035138) have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol.

ReferenceCitation: Liu-Seifert H, Siemers E, Price K, Han B, Selzler KJ, Henley D, Sundell K, Aisen P, Cummings J, Raskin J, Mohs R; Alzheimer's Disease Neuroimaging Initiative. Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer's Disease. J Alzheimers Dis. 2015;47(1):205-14. doi: 10.3233/JAD-142508.

name: Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA

family: Liu-Seifert

full_name: Hong Liu-Seifert

given: Hong

family: Siemers

full_name: Eric Siemers

given: Eric

family: Price

full_name: Karen Price

given: Karen

family: Han

full_name: Baoguang Han

given: Baoguang

family: Selzler

full_name: Katherine J. Selzler

given: Katherine J.

name: Indiana University School of Medicine, Indianapolis, IN, USA

family: Henley

full_name: David Henley

given: David

family: Sundell

full_name: Karen Sundell

name: Department of Neurosciences, University of California San Diego, San Diego, CA, USA

family: Aisen

full_name: Paul Aisen

given: Paul

name: Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA

family: Cummings

full_name: Jeffrey Cummings

given: Jeffrey

family: Raskin

full_name: Joel Raskin

given: Joel

family: Mohs

full_name: Richard Mohs

given: Richard

name: the Alzheimer’s Disease Neuroimaging Initiative

journal_name: Journal of Alzheimer's Disease

oa_host_type: repository

repository_institution: Indiana University - IUScholarWorks

repositories_institution:
Indiana University - IUScholarWorks
PubMed Central - Europe PMC

publisher: IOS Press

publisher_dissemination: IOS Press

publisher_group: IOS Press

publisher_normalized: IOS Press

title: Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer’s Disease

ReferenceCitation: Henley DB, Dowsett SA, Chen YF, Liu-Seifert H, Grill JD, Doody RS, Aisen P, Raman R, Miller DS, Hake AM, Cummings J. Alzheimer's disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther. 2015 Jun 25;7(1):43. doi: 10.1186/s13195-015-0127-0. eCollection 2015.

full_name: David B Henley

given: David B

family: Dowsett

full_name: Sherie A Dowsett

given: Sherie A

family: Chen

full_name: Yun-Fei Chen

given: Yun-Fei

repository_normalized: California Digital Library - eScholarship

repositories_institution: University of California - eScholarship University of California

title: Alzheimer’s disease progression by geographical region in a clinical trial setting

location_country:
Italy
Brazil
Serbia
Mexico
Germany
France
Bulgaria
Japan
Korea, Republic of
Romania
Hungary
Russian Federation
China
Turkey
United States
Canada
Taiwan
Ukraine

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: An Open-label, Randomized, Multicenter, Active-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of Albinterferon Alfa 2b Administered Every 4 Weeks Plus Ribavirin in Interferon Alfa-naïve Patients With Genotype 2/3 Chronic Hepatitis C

summary: This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis

enrollment_type: Anticipated

ReferenceCitation: Pianko S, Zeuzem S, Chuang WL, Foster GR, Sarin SK, Flisiak R, Lee CM, Andreone P, Piratvisuth T, Shah S, Sood A, George J, Gould M, Komolmit P, Thongsawat S, Tanwandee T, Rasenack J, Li Y, Pang M, Yin Y, Feutren G, Jacobson IM; B2202 Study Team. Randomized trial of albinterferon alfa-2b every 4 weeks for chronic hepatitis C virus genotype 2/3. J Viral Hepat. 2012 Sep;19(9):623-34. doi: 10.1111/j.1365-2893.2012.01586.x. Epub 2012 Mar 21.

family: Pianko

full_name: S. Pianko

given: S.

family: Zeuzem

full_name: S. Zeuzem

family: Chuang

full_name: W.-L. Chuang

family: Foster

full_name: G. R. Foster

given: G. R.

family: Sarin

full_name: S. K. Sarin

given: S. K.

family: Flisiak

full_name: R. Flisiak

given: R.

family: Lee

full_name: C.-M. Lee

family: Andreone

full_name: P. Andreone

given: P.

family: Piratvisuth

full_name: T. Piratvisuth

given: T.

family: Shah

full_name: S. Shah

family: Sood

full_name: A. Sood

given: A.

family: George

full_name: J. George

given: J.

family: Gould

full_name: M. Gould

given: M.

family: Komolmit

full_name: P. Komolmit

family: Thongsawat

full_name: S. Thongsawat

family: Tanwandee

full_name: T. Tanwandee

family: Rasenack

full_name: J. Rasenack

family: Li

full_name: Y. Li

given: Y.

family: Pang

full_name: M. Pang

family: Yin

full_name: Y. Yin

family: Feutren

full_name: G. Feutren

given: G.

family: Jacobson

full_name: I. M. Jacobson

given: I. M.

journal_name: Journal of Viral Hepatitis

location_country:
Italy
India
France
Poland
Greece
Thailand
Australia
Spain
Germany
United Kingdom
Canada
Taiwan

location_facility:
Novartis Investigative site
Novartis Investigative Site


title: A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin

summary: The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.

ReferenceCitation: Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.

family: Perl

full_name: Shira Perl

given: Shira

family: Cook

full_name: William Cook

given: William

family: Wei

full_name: Cheryl Wei

given: Cheryl

family: Iqbal

full_name: Nayyar Iqbal

given: Nayyar

family: Hirshberg

full_name: Boaz Hirshberg

given: Boaz

journal_name: Diabetes Therapy

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Cook W, Minervini G, Bryzinski B, Hirshberg B. Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgrad Med. 2014 Oct;126(6):19-32. doi: 10.3810/pgm.2014.10.2818.

family: Minervini

full_name: Gianmaria Minervini

given: Gianmaria

family: Bryzinski

full_name: Brian Bryzinski

given: Brian

journal_name: Postgraduate Medicine

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Saxagliptin Efficacy and Safety in Patients with Type 2 Diabetes Mellitus Stratified by Cardiovascular Disease History and Cardiovascular Risk Factors: Analysis of 3 Clinical Trials

ReferenceCitation: Barnett AH, Charbonnel B, Li J, Donovan M, Fleming D, Iqbal N. Saxagliptin add-on therapy to insulin with or without metformin for type 2 diabetes mellitus: 52-week safety and efficacy. Clin Drug Investig. 2013 Oct;33(10):707-17. doi: 10.1007/s40261-013-0107-8.

family: Barnett

full_name: Anthony H. Barnett

given: Anthony H.

family: Charbonnel

full_name: Bernard Charbonnel

given: Bernard

full_name: Jia Li

given: Jia

family: Donovan

full_name: Mark Donovan

given: Mark

family: Fleming

full_name: Douglas Fleming

title: Saxagliptin Add-on Therapy to Insulin With or Without Metformin for Type 2 Diabetes Mellitus: 52-Week Safety and Efficacy

ReferenceCitation: Barnett AH, Charbonnel B, Donovan M, Fleming D, Chen R. Effect of saxagliptin as add-on therapy in patients with poorly controlled type 2 diabetes on insulin alone or insulin combined with metformin. Curr Med Res Opin. 2012 Apr;28(4):513-23. doi: 10.1185/03007995.2012.665046. Epub 2012 Mar 1.

location_country:
South Africa
India
Mexico
France
Poland
Hungary
Russian Federation
United States
United Kingdom
Canada

location_facility: Panhandle Family Care Assoc. & Coastal Palms Res. Grp Inc.


title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone

summary: This 3 arm study will assess the efficacy of taspoglutide on glycemic control (as assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable metformin plus pioglitazone treatment. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

location_country:
Brazil
Guatemala
Costa Rica
Mexico
Germany
France
Puerto Rico
United States
Canada


lead_sponsor: Translational Research in Oncology

location_country:
United States
France
Israel
Ireland
Spain
Germany
United Kingdom
Canada

location_facility: Hematology and Oncology Specialists, LLC

location_facility: Wake Forest University Baptist Medical Center

location_facility: North Valley Hematology/Oncology Medical Group

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Hospital Universitario Virgen Macarena de Sevilla

location_facility: Central Hematology Oncology Medical Group Inc.

location_facility: Central Coast Medical Oncology Corporation

location_facility: Winship Cancer Institute Emory University School of Medicine

title: A Randomized, Double-blind, Placebo Controlled, Multi-center, Phase II Study of Adding AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) to First Line Chemotherapy in Patients With Optimally Debulked ( < 1 cm ) Epithelial Ovarian Cancer

summary: This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.


title: Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions

summary: Our hypothesis is that the addition of ShearWave Elastography (SWE) to a conventional breast ultrasound examination provides useful information for the radiologist when imaging lesions in the breast, as compared to conventional grayscale ultrasound alone.

study_type: Observational

time_perspective: Cross-Sectional

ReferenceCitation: Cosgrove DO, Berg WA, Doré CJ, Skyba DM, Henry JP, Gay J, Cohen-Bacrie C; BE1 Study Group. Shear wave elastography for breast masses is highly reproducible. Eur Radiol. 2012 May;22(5):1023-32. doi: 10.1007/s00330-011-2340-y. Epub 2011 Dec 31.

family: Cosgrove

full_name: David O. Cosgrove

given: David O.

family: Berg

full_name: Wendie A. Berg

given: Wendie A.

family: Doré

full_name: Caroline J Doré

given: Caroline J

family: Skyba

full_name: Danny M. Skyba

given: Danny M.

family: Henry

full_name: Jean-Pierre Henry

given: Jean-Pierre

family: Gay

full_name: Joel Gay

given: Joel

family: Cohen-Bacrie

full_name: Claude Cohen-Bacrie

given: Claude

journal_name: European Radiology

ReferenceCitation: Berg WA, Cosgrove DO, Doré CJ, Schäfer FK, Svensson WE, Hooley RJ, Ohlinger R, Mendelson EB, Balu-Maestro C, Locatelli M, Tourasse C, Cavanaugh BC, Juhan V, Stavros AT, Tardivon A, Gay J, Henry JP, Cohen-Bacrie C; BE1 Investigators. Shear-wave elastography improves the specificity of breast US: the BE1 multinational study of 939 masses. Radiology. 2012 Feb;262(2):435-49. doi: 10.1148/radiol.11110640.

family: Schäfer

full_name: Fritz K. W. Schäfer

given: Fritz K. W.

family: Svensson

full_name: William E. Svensson

given: William E.

family: Hooley

full_name: Regina J. Hooley

given: Regina J.

family: Ohlinger

full_name: Ralf Ohlinger

given: Ralf

family: Mendelson

full_name: Ellen B. Mendelson

given: Ellen B.

family: Balu-Maestro

full_name: Catherine Balu-Maestro

given: Catherine

publisher: Radiological Society of North America (RSNA)

title: Shear-wave Elastography Improves the Specificity of Breast US: The BE1 Multinational Study of 939 Masses

location_country:
Italy
United States
France
Germany
United Kingdom

location_facility: Northwestern Memorial Hospital, Dept. of Radiology

location_facility: University of Southern California - LAC+USC Medical Center, OPD Rm 3P61

location_facility: Thomas Jefferson Medical Center, Department of Radiology

location_facility: Yale Medical Center, Department of Diagnostic Radiology


title: A Phase 4, Multicenter, Open-Label, Assessor-Blinded Switch Study of the Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) or Adalimumab (HUMIRA).

summary: The purpose of this study is to assess the effectiveness of treatment in patients with active rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment with etanercept or adalimumab in addition to methotrexate.

ReferenceCitation: Fleischmann R, Goldman JA, Leirisalo-Repo M, Zanetakis E, El-Kadi H, Kellner H, Bolce R, DeHoratius R, Wang J, Decktor D. Infliximab efficacy in rheumatoid arthritis after an inadequate response to etanercept or adalimumab: results of a target-driven active switch study. Curr Med Res Opin. 2014 Nov;30(11):2139-49. doi: 10.1185/03007995.2014.942416. Epub 2014 Jul 30.

name:
Metroplex Center for Clinical Research
Dallas, TXUSA

family: Fleischmann

full_name: Roy Fleischmann

given: Roy

name:
Rheumatology, Atlanta Center for Clinical Research
Atlanta, GAUSA

family: Goldman

full_name: John A. Goldman

given: John A.

name:
Department of Medicine, Helsinki University Central Hospital and University of Helsinki
HelsinkiFinland

family: Leirisalo-Repo

full_name: Marjatta Leirisalo-Repo

given: Marjatta

name:
Rheumatology, Oklahoma Center for Arthritis Therapy and Research Inc.
Tulsa, OKUSA

family: Zanetakis

full_name: Ellen Zanetakis

given: Ellen

name: Rheumatology, Arthritis & Osteoporosis Associates PA Freehold, NJUSA

family: El-Kadi

full_name: Hisham El-Kadi

given: Hisham

name:
Center for Joint Diseases
MunichGermany

family: Kellner

full_name: Herbert Kellner

given: Herbert

name:
Medical Affairs, Janssen Biotech Inc
Horsham, PAUSA

name:
Currently of Crescendo Bioscience
San Francisco, CAUSA

family: Bolce

full_name: Rebecca Bolce

given: Rebecca

name:
Medical Affairs, Janssen Scientific Affairs, LLC
Horsham, PAUSA

name:
Department of Medicine, Jefferson Medical College, Thomas Jefferson University
Philadelphia, PAUSA

family: DeHoratius

full_name: Raphael DeHoratius

given: Raphael

name: Janssen Research & Development Belle Mead, NJUSA

family: Wang

full_name: Jim Wang

given: Jim

name:
Currently of Regeneron Pharmaceuticals, Inc.
TarrytownNY, USA

family: Decktor

full_name: Dennis Decktor

given: Dennis

journal_name: Current Medical Research and Opinion

publisher: Informa Healthcare

lead_sponsor: Centocor Ortho Biotech Services, L.L.C.

location_country:
Austria
Netherlands
Germany
Finland
France
Israel
Spain
United States
United Kingdom
Canada

intervention_type: Biological


ReferenceCitation: Reynes J, Trinh R, Pulido F, Soto-Malave R, Gathe J, Qaqish R, Tian M, Fredrick L, Podsadecki T, Norton M, Nilius A. Lopinavir/ritonavir combined with raltegravir or tenofovir/emtricitabine in antiretroviral-naive subjects: 96-week results of the PROGRESS study. AIDS Res Hum Retroviruses. 2013 Feb;29(2):256-65. doi: 10.1089/AID.2011.0275. Epub 2012 Aug 3.

name: Department of Infectious and Tropical Diseases, Montpellier University Hospital, Montpellier, France.

family: Reynes

full_name: Jacques Reynes

given: Jacques

family: Trinh

full_name: Roger Trinh

given: Roger

name: Unidad VIH, Hospital Universitario 12 de Octubre, Universidad Complutense de Madrid, Madrid, Spain.

family: Pulido

full_name: Federico Pulido

given: Federico

name: University of Puerto Rico, School of Medicine, Infectious Diseases Section, San Juan, Puerto Rico and Innovative Care PSC, Bayamon, Puerto Rico.

family: Soto-Malave

full_name: Ruth Soto-Malave

given: Ruth

family: Gathe

full_name: Joseph Gathe

given: Joseph

family: Qaqish

full_name: Roula Qaqish

given: Roula

family: Tian

full_name: Min Tian

given: Min

family: Fredrick

full_name: Linda Fredrick

given: Linda

family: Podsadecki

full_name: Thomas Podsadecki

given: Thomas

family: Norton

full_name: Michael Norton

given: Michael

family: Nilius

full_name: Angela Nilius

given: Angela

journal_name: AIDS Research and Human Retroviruses

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

title: Lopinavir/Ritonavir Combined with Raltegravir or Tenofovir/Emtricitabine in Antiretroviral-Naive Subjects: 96-Week Results of the PROGRESS Study

ReferenceCitation: Reynes J, Lawal A, Pulido F, Soto-Malave R, Gathe J, Tian M, Fredrick LM, Podsadecki TJ, Nilius AM. Examination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/ emtricitabine in antiretroviral-naïve subjects: the progress study, 48-week results. HIV Clin Trials. 2011 Sep-Oct;12(5):255-67. doi: 10.1310/hct1205-255.

family: Lawal

full_name: Adebayo Lawal

given: Adebayo

full_name: Linda M. Fredrick

given: Linda M.

full_name: Thomas J. Podsadecki

given: Thomas J.

full_name: Angela M. Nilius

given: Angela M.

journal_name: HIV Clinical Trials

title: Examination of Noninferiority, Safety, and Tolerability of Lopinavir/ritonavir and Raltegravir Compared with Lopinavir/ritonavir and Tenofovir/ Emtricitabine in Antiretroviral-Naïve Subjects: The PROGRESS Study, 48-Week Results

location_country:
Italy
France
Poland
Puerto Rico
Spain
United States
Canada

location_facility:
Site Reference ID/Investigator# 8050
Site Reference ID/Investigator# 7693
Site Reference ID/Investigator# 7690
Site Reference ID/Investigator# 7689
Site Reference ID/Investigator# 8431
Site Reference ID/Investigator# 7959
Site Reference ID/Investigator# 7697
Site Reference ID/Investigator# 8395
Site Reference ID/Investigator# 8429
Site Reference ID/Investigator# 7695
Site Reference ID/Investigator# 7821
Site Reference ID/Investigator# 8396
Site Reference ID/Investigator# 7700
Site Reference ID/Investigator# 8052
Site Reference ID/Investigator# 11461
Site Reference ID/Investigator# 8051
Site Reference ID/Investigator# 7692
Site Reference ID/Investigator# 7831
Site Reference ID/Investigator# 8393
Site Reference ID/Investigator# 8402
Site Reference ID/Investigator# 8063
Site Reference ID/Investigator# 7691
Site Reference ID/Investigator# 7698
Site Reference ID/Investigator# 8099
Site Reference ID/Investigator# 8433
Site Reference ID/Investigator# 7713
Site Reference ID/Investigator# 8432
Site Reference ID/Investigator# 7789
Site Reference ID/Investigator# 8403
Site Reference ID/Investigator# 8221
Site Reference ID/Investigator# 11102
Site Reference ID/Investigator# 8394
Site Reference ID/Investigator# 8425
Site Reference ID/Investigator# 8426
Site Reference ID/Investigator# 8424
Site Reference ID/Investigator# 7963
Site Reference ID/Investigator# 7960

title: A Randomized, Open-label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily in Antiretroviral Naive, HIV-1 Infected Subjects

summary: The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with a human immunodeficiency virus type 1 ( HIV-1) integrase inhibitor in antiretroviral naive HIV-1 infected subjects.


title: A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Schizophrenia

acronym: ASPIRE

summary:
The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia

The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending relapse for up to 38 weeks.

ReferenceCitation: Kane JM, Sanchez R, Baker RA, Eramo A, Peters-Strickland T, Perry PP, Johnson BR, Tsai LF, Carson WH, McQuade RD, Fleischhacker WW. Patient-Centered Outcomes with Aripiprazole Once-Monthly for Maintenance Treatment in Patients with Schizophrenia: Results From Two Multicenter, Randomized, Double-Blind Studies. Clin Schizophr Relat Psychoses. 2015 Summer;9(2):79-87. doi: 10.3371/CSRP.KASA.022015. Epub 2015 Feb 24.

family: Kane

full_name: John M. Kane

given: John M.

family: Sanchez

full_name: Raymond Sanchez

given: Raymond

family: Baker

full_name: Ross A. Baker

given: Ross A.

family: Eramo

full_name: Anna Eramo

given: Anna

family: Peters-Strickland

full_name: Timothy Peters-Strickland

given: Timothy

family: Perry

full_name: Pamela P. Perry

given: Pamela P.

family: Johnson

full_name: Brian R. Johnson

given: Brian R.

family: Tsai

full_name: Lan-Feng Tsai

given: Lan-Feng

family: Carson

full_name: William H. Carson

given: William H.

family: McQuade

full_name: Robert D. McQuade

given: Robert D.

family: Fleischhacker

full_name: W. Wolfgang Fleischhacker

given: W. Wolfgang

bso_classification: Social sciences

journal_name: Clinical Schizophrenia & Related Psychoses

publisher: Longdom Group

publisher_dissemination: Longdom Group

publisher_group: Longdom Group

publisher_normalized: Longdom Group

ReferenceCitation: Fleischhacker WW, Sanchez R, Perry PP, Jin N, Peters-Strickland T, Johnson BR, Baker RA, Eramo A, McQuade RD, Carson WH, Walling D, Kane JM. Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study. Br J Psychiatry. 2014 Aug;205(2):135-44. doi: 10.1192/bjp.bp.113.134213. Epub 2014 Jun 12.

family: Jin

full_name: Na Jin

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Italy
Austria
Chile
South Africa
Croatia
Bulgaria
France
Poland
Thailand
Hungary
Belgium
Puerto Rico
Estonia
United States
Korea, Republic of


ReferenceCitation: Awada A, Dirix L, Manso Sanchez L, Xu B, Luu T, Diéras V, Hershman DL, Agrapart V, Ananthakrishnan R, Staroslawska E. Safety and efficacy of neratinib (HKI-272) plus vinorelbine in the treatment of patients with ErbB2-positive metastatic breast cancer pretreated with anti-HER2 therapy. Ann Oncol. 2013 Jan;24(1):109-16. doi: 10.1093/annonc/mds284. Epub 2012 Sep 11.

family: Awada

full_name: A. Awada

given: A.

family: Dirix

full_name: L. Dirix

given: L.

family: Manso Sanchez

full_name: L. Manso Sanchez

family: Xu

full_name: B. Xu

given: B.

family: Luu

full_name: T. Luu

given: T.

family: Diéras

full_name: V. Diéras

given: V.

family: Hershman

full_name: D.L. Hershman

family: Agrapart

full_name: V. Agrapart

family: Ananthakrishnan

full_name: R. Ananthakrishnan

given: R.

family: Staroslawska

full_name: E. Staroslawska

given: E.

journal_name: Annals of Oncology

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

location_country:
Sweden
Hong Kong
Netherlands
Spain
France
Poland
Belgium
China
United States
United Kingdom
Taiwan

location_facility: The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army

location_facility: Institut Curie, Département d'Oncologie Médicale

location_facility: St.-Augustinus Hospital Oncology Department

location_facility: Wojskowy Instytut Medyczny, Klinika Onkologii

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center

location_facility: Martini Ziekenhuis / Afdeling Interne Geneeskunde

location_facility: Cancer Hospital, Chinese Academy of Medical Sciences

location_facility: Centrum Onkologii Ziemii Lubelskiej, Oddział Chemioterapii

location_facility: Hematology Oncology Associates of Rockland

location_facility: Hospital 12 de Octubre, Servicio de Oncologia Medica

location_facility: Guy's and St. Thomas' NHS Foundation Trust, Guy's Hospital

location_facility: Hospital Arnau de Vilanova, Servicio de Oncologia Medica

location_facility: Chinese People's Liberation Army General Hospital

location_facility: Onkologiska Kliniken Universitetssjukhuset i Lund

title: A Phase 1/2 Study Of HKI-272 In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer

summary:
The purpose of this study is to identify the highest tolerable dose of neratinib (HKI-272) in combination with vinorelbine and to assess the safety of the combination of the two drugs as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors.

The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of HKI-272 and vinorelbine in patients with advanced solid tumors. In the second part of the study, approximately 60 additional subjects with metastatic ErbB-2-positive breast cancer, with no prior exposure to lapatinib, are planned to be added to better define the tolerability and preliminary activity of HKI-272 in combination with vinorelbine. Up to 20 additional subjects with ErbB-2-positive breast cancer with prior lapatinib exposure are also planned to be enrolled in part 2 for exploratory analyses.


ReferenceCitation: Arnold S, Badalamenti V, Diaz A, Gasalla T, McShea C, Whitesides J, Fakhoury T. Conversion to brivaracetam monotherapy for the treatment of patients with focal seizures: Two double-blind, randomized, multicenter, historical control, Phase III studies. Epilepsy Res. 2018 Mar;141:73-82. doi: 10.1016/j.eplepsyres.2018.02.005. Epub 2018 Feb 12.

family: Arnold

full_name: Stephan Arnold

given: Stephan

family: Badalamenti

full_name: Vincent Badalamenti

given: Vincent

family: Diaz

full_name: Anyzeila Diaz

given: Anyzeila

family: Gasalla

full_name: Teresa Gasalla

given: Teresa

family: McShea

full_name: Cindy McShea

given: Cindy

family: Whitesides

full_name: John Whitesides

given: John

family: Fakhoury

full_name: Toufic Fakhoury

given: Toufic

journal_name: Epilepsy Research

lead_sponsor: UCB Pharma

location_country:
Italy
United States
France
Hungary
Spain
Germany

title: An International, Double-blind, Randomized, Multi-center, Parallel Group, Historical-control Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures With or Without Secondary Generalization.

summary: Antiepileptic Drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of BRV in the conversion of partial onset seizure patients from combination treatment to monotherapy.