ReferenceCitation: Llibre JM, Hung CC, Brinson C, et al. Efficacy, safety, and tolerability of dolutegravir plus rilpivirine for the maintenance of virologic suppression in HIV-1-infected adults: the phase III, randomized, open-label, active-controlled, noninferiority SWORD-1 and SWORD-2 studies. Lancet [epublished ahead of print] 6 January 2018.

ReferenceCitation: Aboud M, Orkin C, Podzamczer D, Bogner JR, Baker D, Khuong-Josses MA, Parks D, Angelis K, Kahl LP, Blair EA, Adkison K, Underwood M, Matthews JE, Wynne B, Vandermeulen K, Gartland M, Smith K. Efficacy and safety of dolutegravir-rilpivirine for maintenance of virological suppression in adults with HIV-1: 100-week data from the randomised, open-label, phase 3 SWORD-1 and SWORD-2 studies. Lancet HIV. 2019 Sep;6(9):e576-e587. doi: 10.1016/S2352-3018(19)30149-3. Epub 2019 Jul 12.

family: Aboud

full_name: Michael Aboud

given: Michael

family: Orkin

full_name: Chloe Orkin

given: Chloe

family: Podzamczer

full_name: Daniel Podzamczer

given: Daniel

family: Bogner

full_name: Johannes R Bogner

given: Johannes R

family: Baker

full_name: David Baker

given: David

family: Khuong-Josses

full_name: Marie-Aude Khuong-Josses

given: Marie-Aude

family: Parks

full_name: David Parks

family: Angelis

full_name: Konstantinos Angelis

given: Konstantinos

family: Kahl

full_name: Lesley P Kahl

given: Lesley P

family: Blair

full_name: Elizabeth A Blair

given: Elizabeth A

family: Adkison

full_name: Kimberly Adkison

given: Kimberly

family: Underwood

full_name: Mark Underwood

given: Mark

family: Matthews

full_name: Jessica E Matthews

given: Jessica E

family: Wynne

full_name: Brian Wynne

given: Brian

family: Vandermeulen

full_name: Kati Vandermeulen

given: Kati

family: Gartland

full_name: Martin Gartland

given: Martin

family: Smith

full_name: Kimberly Smith

journal_name: The Lancet HIV

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Efficacy and safety of dolutegravir–rilpivirine for maintenance of virological suppression in adults with HIV-1: 100-week data from the randomised, open-label, phase 3 SWORD-1 and SWORD-2 studies

ReferenceCitation: Llibre JM, Hung CC, Brinson C, Castelli F, Girard PM, Kahl LP, Blair EA, Angelis K, Wynne B, Vandermeulen K, Underwood M, Smith K, Gartland M, Aboud M. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018 Mar 3;391(10123):839-849. doi: 10.1016/S0140-6736(17)33095-7. Epub 2018 Jan 6. Erratum in: Lancet. 2018 Feb 1;:.

family: Llibre

full_name: Josep M Llibre

given: Josep M

family: Hung

full_name: Chien-Ching Hung

given: Chien-Ching

family: Brinson

full_name: Cynthia Brinson

given: Cynthia

family: Castelli

full_name: Francesco Castelli

given: Francesco

family: Girard

full_name: Pierre-Marie Girard

given: Pierre-Marie

ReferenceCitation: McComsey GA, Lupo S, Parks D, Poggio MC, De Wet J, Kahl LP, Angelis K, Wynne B, Vandermeulen K, Gartland M, Cupo M, Aboud M; 202094 Sub-Study Investigators. Switch from tenofovir disoproxil fumarate combination to dolutegravir with rilpivirine improves parameters of bone health. AIDS. 2018 Feb 20;32(4):477-485. doi: 10.1097/QAD.0000000000001725.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Italy
United States
Germany
France
Argentina
Australia
Russian Federation
Spain
Canada
United Kingdom
Taiwan

title: A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Rilpivirine From Current INI-, NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-infected Adults Who Are Virologically Suppressed

summary: The aim of this study is to determine if virologically suppressed, human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include 2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will participate in the Early Switch Phase where they will either switch from their CAR to DTG + RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible participants will proceed to the Late Switch Phase where all participants in both DTG + RPV and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148, subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study is planned to be conducted in approximately 476 participants.


ReferenceType: derived

ReferenceCitation: Perl AE, Martinelli G, Cortes JE, Neubauer A, Berman E, Paolini S, Montesinos P, Baer MR, Larson RA, Ustun C, Fabbiano F, Erba HP, Di Stasi A, Stuart R, Olin R, Kasner M, Ciceri F, Chou WC, Podoltsev N, Recher C, Yokoyama H, Hosono N, Yoon SS, Lee JH, Pardee T, Fathi AT, Liu C, Hasabou N, Liu X, Bahceci E, Levis MJ. Gilteritinib or Chemotherapy for Relapsed or Refractory FLT3-Mutated AML. N Engl J Med. 2019 Oct 31;381(18):1728-1740. doi: 10.1056/NEJMoa1902688.

name: From the Abramson Cancer Center, University of Pennsylvania (A.E.P.), and Thomas Jefferson University (M.K.) — both in Philadelphia; Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS), Meldola (G.M.), L. and A. Seràgnoli Institute of Hematology, Bologna University Medical School, Bologna (S.P.), Ospedali Riuniti Villa Sofia-Cervello, Palermo (F.F.), and IRCCS San Raffaele Scientific Institute, Milan (F.C.) — all in Italy;...

family: Perl

full_name: Alexander E. Perl

given: Alexander E.

sequence: first

family: Martinelli

full_name: Giovanni Martinelli

given: Giovanni

sequence: additional

family: Cortes

full_name: Jorge E. Cortes

given: Jorge E.

family: Neubauer

full_name: Andreas Neubauer

given: Andreas

family: Berman

full_name: Ellin Berman

given: Ellin

family: Paolini

full_name: Stefania Paolini

given: Stefania

family: Montesinos

full_name: Pau Montesinos

given: Pau

family: Baer

full_name: Maria R. Baer

given: Maria R.

family: Larson

full_name: Richard A. Larson

given: Richard A.

family: Ustun

full_name: Celalettin Ustun

given: Celalettin

family: Fabbiano

full_name: Francesco Fabbiano

family: Erba

full_name: Harry P. Erba

given: Harry P.

family: Di Stasi

full_name: Antonio Di Stasi

given: Antonio

family: Stuart

full_name: Robert Stuart

given: Robert

family: Olin

full_name: Rebecca Olin

given: Rebecca

family: Kasner

full_name: Margaret Kasner

given: Margaret

family: Ciceri

full_name: Fabio Ciceri

given: Fabio

family: Chou

full_name: Wen-Chien Chou

given: Wen-Chien

family: Podoltsev

full_name: Nikolai Podoltsev

given: Nikolai

family: Recher

full_name: Christian Recher

given: Christian

family: Yokoyama

full_name: Hisayuki Yokoyama

given: Hisayuki

family: Hosono

full_name: Naoko Hosono

given: Naoko

family: Yoon

full_name: Sung-Soo Yoon

given: Sung-Soo

family: Lee

full_name: Je-Hwan Lee

given: Je-Hwan

family: Pardee

full_name: Timothy Pardee

given: Timothy

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

repository_institution: Thomas Jefferson University - Jefferson Digital Commons

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Italy
United States
Germany
France
Japan
Poland
Israel
Belgium
Spain
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility:
Site JP81021
Site US10084
Site ES34016
Site US10023
Site BE32002
Site IT39010
Site US10072
Site FR33014
Site IT39007
Site JP81014
Site ES34005
Site US10027
Site IL97203
Site JP81026
Site KR82002
Site TW88602
Site IL97208
Site JP81025
Site IL97209
Site JP81024
Site TW88603
Site IT39005
Site JP81005
Site US10067
Site US10073
Site JP81010
Site TW88608
Site CA15004
Site US10035
Site TR90001
Site JP81018
Site JP81016
Site FR33008
Site TR90004
Site JP81012
Site FR33010
Site KR82001
Site KR82011
Site JP81002
Site KR82009
Site ES34009
Site ES34011
Site US10078
Site US10046
Site US10085
Site DE49002
Site IT39001
Site TW88606
Site DE49011
Site KR82007
Site US10013
Site DE49003
Site IT39011
Site ES34012
Site GB44014
Site US10074
Site US10045
Site IT39002
Site PL48005
Site JP81011
Site US10048
Site KR82003
Site FR33009
Site JP81008
Site US10001
Site FR33002
Site JP81006
Site DE49010
Site JP81020
Site TW88609
Site GB44013
Site TW88605
Site US10012
Site US10022
Site JP81013
Site US10044
Site IL97206
Site IL97201
Site ES34014
Site US10063
Site JP81004
Site KR82005
Site US10057
Site KR82010
Site US10076
Site ES34017
Site US10075
Site IL97210
Site US10011
Site US10081
Site CA15003
Site CA15015
Site TW88601
Site US10037
Site JP81017
Site GB44015
Site JP81023
Site US10010
Site US10080
Site TW88604
Site KR82004
Site PL48004
Site US10008
Site US10034
Site US10014
Site IT39004
Site US10006
Site CA15001
Site TW88610
Site TW88611
Site FR33013
Site JP81009
Site KR82008
Site ES34010
Site GB44003
Site PL48002
Site JP81027
Site JP81007
Site US10087
Site DE49009
Site US10077
Site US10041
Site US10058
Site US10024
Site US10005
Site JP81022

title: A Phase 3 Open-Label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation

summary:
The purpose of this study is to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who are refractory to or have relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy, and to determine the efficacy of ASP2215 therapy as assessed by the rate of complete remission and complete remission with partial hematological recovery (CR/CRh) in these participants.

This study will also determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.


type: EudraCT Number

title: A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy, Safety and Tolerability Trial of Once Daily, Oral Doses of Empagliflozin as Adjunctive to inSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)

summary: Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week follow-up period.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceCitation: Rosenstock J, Marquard J, Laffel LM, Neubacher D, Kaspers S, Cherney DZ, Zinman B, Skyler JS, George J, Soleymanlou N, Perkins BA. Empagliflozin as Adjunctive to Insulin Therapy in Type 1 Diabetes: The EASE Trials. Diabetes Care. 2018 Dec;41(12):2560-2569. doi: 10.2337/dc18-1749. Epub 2018 Oct 4.

family: Rosenstock

full_name: Julio Rosenstock

given: Julio

family: Marquard

full_name: Jan Marquard

given: Jan

family: Laffel

full_name: Lori M. Laffel

given: Lori M.

family: Neubacher

full_name: Dietmar Neubacher

given: Dietmar

family: Kaspers

full_name: Stefan Kaspers

given: Stefan

family: Cherney

full_name: David Z. Cherney

given: David Z.

family: Zinman

full_name: Bernard Zinman

given: Bernard

family: Skyler

full_name: Jay S. Skyler

given: Jay S.

family: George

full_name: Jyothis George

given: Jyothis

family: Soleymanlou

full_name: Nima Soleymanlou

given: Nima

family: Perkins

full_name: Bruce A. Perkins

given: Bruce A.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Diabetes Care

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

lead_sponsor: Boehringer Ingelheim

location_country:
Austria
United States
Sweden
Netherlands
Germany
Finland
France
Czechia
Poland
Norway
Australia
Belgium
Spain
Denmark
Canada
United Kingdom
Taiwan

location_facility: Wellcome Trust Clinical Research Facility

location_facility: Helse Møre og Romsdal HF, Ålesund sjukehus

location_facility: Diabetes and Obesity Clinical Trials Center

location_facility: NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny

location_facility: The Center for Diabetes and Endocrine Care

location_facility: Med Univ Bialystok Clin Dep Endocrinol, Diabetol & Int Dis

location_facility: Marcinkowski Poznan Univ of Med Sci, Clin Dept Diab, Poznan

location_facility: Albany Medical Center / Albany Medical College

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: MultiCare Institute for Research and Innovation

location_facility: University Physicians Group Research Division

location_facility: NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom

location_facility: LMC Endocrinology Centres (Calgary) Ltd.

location_facility: Albert Schweitzer Ziekenhuis, Zwijndrecht

location_facility: General Univ.hosp.in Prague (VFN), Diabetes ambulance

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Royal Brisbane & Women's Hospital-Endocrinology

location_facility: Diabetes/Lipid Management and Research Center

location_facility: Diabetes and Endocrinology Consultants, PC

location_facility: The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital

location_facility: Diabetology and Internal Practice Dr. Vladimir Lelek

location_facility: Allgemeinmedizinische und Diabetologische Schwerpunktpraxis

location_facility: Desert Endocrinology Clinical Research Center

location_facility: Southern New Hampshire Diabetes and Endocrinology

location_facility: Oslo Universitetssykehus HF, Aker Sykehus

location_facility: Rocky Mountain Diabetes and Osteoporosis Center

location_facility: VIVIT Instit.am LKH Feldkirch,Abt.f.Innere Med.u.Kardiologie

location_facility: ikfe - Institut für klinische Forschung und Entwicklung Berlin GmbH

location_facility: HOP les Portes du Sud, Diabéto, Vénissieux

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Multicenter, Prospective, Open-label, Non-controlled Clinical Trial to Assess the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Patients With Myasthenia Gravis Exacerbations

summary: This was a multicenter, prospective, open-label, non-controlled study to assess the efficacy and safety of an IV dose of 2 g/kg of IGIV-C in subjects with MG exacerbations.

lead_sponsor: Grifols Therapeutics LLC

location_country:
South Africa
France
Czechia
Poland
Romania
Hungary
Belgium
Argentina
Russian Federation
Estonia
Canada
Latvia

location_facility: State Budgetary Institution of Healthcare "Samara Regional Clinical Hospital. V.D.Seredavin

location_facility: Spitalul Clinic Judetean de Urgenta Targu-Mures

location_facility: Fakultni nemocnice Brno, Neurologicka klinika

location_facility: University of Szeged, Faculty of Medicine

location_facility: University Health Network (UHN) - Toronto General Hospital

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház

location_facility: Fakultni nemocnice Ostrava, Neurologická klinika

location_facility: State Budgetary Institution of Healthcare of Nizhniy Novgorod region. Nizhniy Novgorod Regional Clinical Hospital named after N.A.Semashko

location_facility: Saint-Petersburg State Budgetary Institution of Healthcare. City Multi-field Hospital # 2

intervention_type: Biological


type: Other Identifier

title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloarthritis

summary: The purpose of this study is to assess the efficacy and safety of ustekinumab in adult participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).

status: Terminated

ReferenceCitation: Deodhar A, Gensler LS, Sieper J, Clark M, Calderon C, Wang Y, Zhou Y, Leu JH, Campbell K, Sweet K, Harrison DD, Hsia EC, van der Heijde D. Three Multicenter, Randomized, Double-Blind, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis. Arthritis Rheumatol. 2019 Feb;71(2):258-270. doi: 10.1002/art.40728. Epub 2018 Dec 29.

name: Oregon Health & Science University Portland

family: Deodhar

full_name: Atul Deodhar

given: Atul

family: Gensler

full_name: Lianne S. Gensler

given: Lianne S.

name: Charite Universitatsmedizin Berlin Berlin Germany

family: Sieper

full_name: Joachim Sieper

given: Joachim

name: Janssen Research & Development, LLC Spring House Pennsylvania

family: Clark

full_name: Michael Clark

given: Michael

family: Calderon

full_name: Cesar Calderon

given: Cesar

family: Wang

full_name: Yuhua Wang

given: Yuhua

family: Zhou

full_name: Yiying Zhou

given: Yiying

family: Leu

full_name: Jocelyn H. Leu

given: Jocelyn H.

family: Campbell

full_name: Kim Campbell

given: Kim

family: Sweet

full_name: Kristen Sweet

given: Kristen

family: Harrison

full_name: Diane D. Harrison

given: Diane D.

name: Hospital of the University of Pennsylvania Philadelphia

family: Hsia

full_name: Elizabeth C. Hsia

given: Elizabeth C.

name: Leiden University Medical Center Leiden The Netherlands

family: Heijde

full_name: Désirée Heijde

given: Désirée

family: Ariel

full_name: Frederico Ariel

given: Frederico

family: Asnal

full_name: Cecilia Adma Asnal

given: Cecilia Adma

family: Berman

full_name: Alberto Berman

given: Alberto

family: Citera

full_name: Gustavo Citera

given: Gustavo

family: Rodriguez

full_name: Graciela Rodriguez

given: Graciela

family: Savio

full_name: Veronica Gabriela Savio

given: Veronica Gabriela

family: Bird

full_name: Paul Bird

given: Paul

family: Griffiths

full_name: Hedley Griffiths

given: Hedley

family: Nicholls

full_name: David Nicholls

given: David

family: Rischmueller

full_name: Maureen Rischmueller

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

title: Three Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis

location_country:
Mexico
France
Czechia
Poland
Hungary
Belgium
Argentina
Australia
Russian Federation
Germany
United Kingdom
Korea, Republic of
Taiwan
Ukraine


title: An Open-label, Single-arm Phase II Study in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) to Evaluate Efficacy and Safety of Treatment With Single Agent Copanlisib and the Impact of Biomarkers Thereupon.

summary: To assess the potential efficacy (in terms of objective response) of single agent copanlisib in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the relationship between efficacy and a potentially predictive biomarker

ReferenceCitation: Lenz G, Hawkes E, Verhoef G, Haioun C, Thye Lim S, Seog Heo D, Ardeshna K, Chong G, Haaber J, Shi W, Gorbatchevsky I, Lippert S, Hiemeyer F, Piraino P, Beckmann G, Peña C, Buvaylo V, Childs BH, Salles G. Single-agent activity of phosphatidylinositol 3-kinase inhibition with copanlisib in patients with molecularly defined relapsed or refractory diffuse large B-cell lymphoma. Leukemia. 2020 Aug;34(8):2184-2197. doi: 10.1038/s41375-020-0743-y. Epub 2020 Feb 14.

family: Lenz

full_name: Georg Lenz

given: Georg

family: Hawkes

full_name: Eliza Hawkes

given: Eliza

family: Verhoef

full_name: Gregor Verhoef

given: Gregor

family: Haioun

full_name: Corinne Haioun

given: Corinne

family: Thye Lim

full_name: Soon Thye Lim

given: Soon

family: Seog Heo

full_name: Dae Seog Heo

given: Dae

family: Ardeshna

full_name: Kirit Ardeshna

given: Kirit

family: Chong

full_name: Geoffrey Chong

given: Geoffrey

family: Haaber

full_name: Jacob Haaber

given: Jacob

family: Shi

full_name: Wei Shi

given: Wei

family: Gorbatchevsky

full_name: Igor Gorbatchevsky

given: Igor

family: Lippert

full_name: Susanne Lippert

given: Susanne

family: Hiemeyer

full_name: Florian Hiemeyer

given: Florian

family: Piraino

full_name: Paolo Piraino

given: Paolo

family: Beckmann

full_name: Georg Beckmann

family: Peña

full_name: Carol Peña

given: Carol

family: Buvaylo

full_name: Viktoriya Buvaylo

given: Viktoriya

family: Childs

full_name: Barrett H. Childs

given: Barrett H.

family: Salles

full_name: Gilles Salles

given: Gilles

journal_name: Leukemia

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

location_country:
Italy
Germany
France
Singapore
Belgium
Australia
Denmark
Canada
United Kingdom
Korea, Republic of


ReferenceCitation: Weber JS, Ascierto PA, Middleton MR, Hennicken D, Zoffoli R, Pieters A, Amadi A, Kupas K, Kotapati S, Moshyk A, Schadendorf D. Indirect treatment comparison of nivolumab versus placebo as adjuvant treatment for resected melanoma. Eur J Cancer. 2021 Nov;158:225-233. doi: 10.1016/j.ejca.2021.08.028. Epub 2021 Oct 15.

family: Weber

full_name: Jeffrey S. Weber

given: Jeffrey S.

family: Ascierto

full_name: Paolo A. Ascierto

given: Paolo A.

family: Middleton

full_name: Mark R. Middleton

given: Mark R.

family: Hennicken

full_name: Delphine Hennicken

given: Delphine

family: Zoffoli

full_name: Roberto Zoffoli

given: Roberto

family: Pieters

full_name: Anne Pieters

given: Anne

family: Amadi

full_name: Adenike Amadi

given: Adenike

family: Kupas

full_name: Katrin Kupas

given: Katrin

family: Kotapati

full_name: Srividya Kotapati

given: Srividya

family: Moshyk

full_name: Andriy Moshyk

given: Andriy

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

journal_name: European Journal of Cancer

ReferenceCitation: Mandala M, Larkin J, Ascierto PA, Del Vecchio M, Gogas H, Cowey CL, Arance A, Dalle S, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez I, Butler MO, Di Giacomo AM, Lutzky J, De La Cruz-Merino L, Atkinson V, Arenberger P, Hill A, Fecher L, Millward M, Khushalani NI, de Pril V, Lobo M, Weber J. Adjuvant nivolumab for stage III/IV melanoma: evaluation of safety outcomes and association with recurrence-free survival. J Immunother Cancer. 2021 Aug;9(8). pii: e003188. doi: 10.1136/jitc-2021-003188.

family: Mandala

full_name: Mario Mandala

given: Mario

family: Larkin

full_name: James Larkin

given: James

full_name: Paolo Antonio Ascierto

given: Paolo Antonio

family: Del Vecchio

full_name: Michele Del Vecchio

given: Michele

family: Gogas

full_name: Helen Gogas

given: Helen

family: Cowey

full_name: C Lance Cowey

given: C Lance

family: Arance

full_name: Ana Arance

given: Ana

family: Dalle

full_name: Stéphane Dalle

given: Stéphane

family: Schenker

full_name: Michael Schenker

given: Michael

family: Grob

full_name: Jean-Jacques Grob

given: Jean-Jacques

ReferenceCitation: Ascierto PA, Del Vecchio M, Mandalá M, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Grob JJ, Chiarion-Sileni V, Márquez-Rodas I, Butler MO, Maio M, Middleton MR, de la Cruz-Merino L, Arenberger P, Atkinson V, Hill A, Fecher LA, Millward M, Khushalani NI, Queirolo P, Lobo M, de Pril V, Loffredo J, Larkin J, Weber J. Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Oncol. 2020 Nov;21(11):1465-1477. doi: 10.1016/S1470-2045(20)30494-0. Epub 2020 Sep 19. Erratum in: Lancet Oncol. 2021 Oct;22(10):e428.

title: Adjuvant nivolumab versus ipilimumab in resected stage IIIB–C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial

ReferenceCitation: Weber J, Mandala M, Del Vecchio M, Gogas HJ, Arance AM, Cowey CL, Dalle S, Schenker M, Chiarion-Sileni V, Marquez-Rodas I, Grob JJ, Butler MO, Middleton MR, Maio M, Atkinson V, Queirolo P, Gonzalez R, Kudchadkar RR, Smylie M, Meyer N, Mortier L, Atkins MB, Long GV, Bhatia S, Lebbé C, Rutkowski P, Yokota K, Yamazaki N, Kim TM, de Pril V, Sabater J, Qureshi A, Larkin J, Ascierto PA; CheckMate 238 Collaborators. Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma. N Engl J Med. 2017 Nov 9;377(19):1824-1835. doi: 10.1056/NEJMoa1709030. Epub 2017 Sep 10.

repository_institution: The University of Queensland - Queensland's institutional digital repository

location_country:
Finland
Greece
Romania
Australia
Belgium
Taiwan
France
Japan
Poland
Norway
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Switzerland
Netherlands
Hungary
Ireland
United States
United Kingdom
Italy
Austria
Czechia
Spain

location_facility: Instituto Nazionale Tumori Fondazione G. Pascale

location_facility: The Cancer Center At Hackensack University Medical Center

location_facility: University Of Arkansas For Medical Sciences

location_facility: Azienda Ospedaleira Universitaria Senese S. Maria Alle Scott

location_facility: St. Luke's Cancer Center - Anderson Campus

location_facility: Medical University of South Carolina Hollings Cancer Center

location_facility: Istituto Nazionale Per La Ricerca Sul Cancro - Oncologia Med

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E Cura Tumori

location_facility: Providence Cancer Center Oncology And Hematology Care

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University Of Washington Cancer Care Alliance

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Washington University School Of Medicine

location_facility: Carolinas Healthcare System / Carolinas Medical Center

location_facility: California Pacific Medical Center Research Institute

title: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 238)

summary: The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.


title: A Multicenter, Randomized, Double-Blind, Placebo Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Experienced Patients With Active Psoriatic Arthritis

summary: The main purpose of this study is to evaluate how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.

ReferenceCitation: Combe B, Tsai TF, Huffstutter JE, Sprabery AT, Lin CY, Park SY, Kronbergs A, Hufford MM, Nash P. Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies. Arthritis Res Ther. 2021 Jan 27;23(1):41. doi: 10.1186/s13075-020-02388-5.

family: Combe

full_name: Bernard Combe

given: Bernard

family: Tsai

full_name: Tsen-Fang Tsai

given: Tsen-Fang

family: Huffstutter

full_name: J. Eugene Huffstutter

given: J. Eugene

family: Sprabery

full_name: Aubrey Trevelin Sprabery

given: Aubrey Trevelin

family: Lin

full_name: Chen-Yen Lin

given: Chen-Yen

family: Park

full_name: So Young Park

given: So Young

family: Kronbergs

full_name: Andris Kronbergs

given: Andris

family: Hufford

full_name: Matthew M. Hufford

given: Matthew M.

family: Nash

full_name: Peter Nash

given: Peter

currency_apc_doaj: GBP

journal_name: Arthritis Research & Therapy

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

repositories:
PubMed Central
Research Square
research-repository.griffith.edu.au

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Orbai AM, Gratacós J, Turkiewicz A, Hall S, Dokoupilova E, Combe B, Nash P, Gallo G, Bertram CC, Gellett AM, Sprabery AT, Birt J, Macpherson L, Geneus VJ, Constantin A. Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2). Rheumatol Ther. 2021 Mar;8(1):199-217. doi: 10.1007/s40744-020-00261-0. Epub 2020 Dec 5.

family: Orbai

full_name: Ana-Maria Orbai

given: Ana-Maria

family: Gratacós

full_name: Jordi Gratacós

given: Jordi

family: Turkiewicz

full_name: Anthony Turkiewicz

given: Anthony

family: Hall

full_name: Stephen Hall

given: Stephen

family: Dokoupilova

full_name: Eva Dokoupilova

given: Eva

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories:
HAL
PubMed Central
research-repository.griffith.edu.au

ReferenceCitation: Schweikert B, Malmberg C, Núñez M, Dilla T, Sapin C, Hartz S. Cost-effectiveness analysis of ixekizumab versus secukinumab in patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis in Spain. BMJ Open. 2020 Aug 13;10(8):e032552. doi: 10.1136/bmjopen-2019-032552.

ReferenceCitation: Combe B, Rahman P, Kameda H, Cañete JD, Gallo G, Agada N, Xu W, Genovese MC. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis. Arthritis Res Ther. 2020 Jan 21;22(1):14. doi: 10.1186/s13075-020-2099-0.

ReferenceCitation: Tillett W, Lin CY, Zbrozek A, Sprabery AT, Birt J. A Threshold of Meaning for Work Disability Improvement in Psoriatic Arthritis Measured by the Work Productivity and Activity Impairment Questionnaire. Rheumatol Ther. 2019 Sep;6(3):379-391. doi: 10.1007/s40744-019-0155-5. Epub 2019 Jun 1.

ReferenceCitation: Coates LC, Orbai AM, Morita A, Benichou O, Kerr L, Adams DH, Shuler CL, Birt J, Helliwell PS. Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients' health-related quality of life and productivity. BMC Rheumatol. 2018 Aug 13;2:24. doi: 10.1186/s41927-018-0030-y. eCollection 2018.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

title: Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients’ health-related quality of life and productivity

ReferenceCitation: Gladman DD, Orbai AM, Klitz U, Wei JC, Gallo G, Birt J, Rathmann S, Shrom D, Marzo-Ortega H. Ixekizumab and complete resolution of enthesitis and dactylitis: integrated analysis of two phase 3 randomized trials in psoriatic arthritis. Arthritis Res Ther. 2019 Jan 29;21(1):38. doi: 10.1186/s13075-019-1831-0.

ReferenceCitation: Genovese MC, Combe B, Kremer JM, Tsai TF, Behrens F, Adams DH, Lee C, Kerr L, Nash P. Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2. Rheumatology (Oxford). 2018 Nov 1;57(11):2001-2011. doi: 10.1093/rheumatology/key182.

name: Division of Immunology and Rheumatology, Stanford University, Palo Alto, CA, USA

name: Departement de Rhumatologie, CHU Montpellier, Montpellier University, Montpellier, France

name: Albany Medical College and The Center for Rheumatology, Albany, NY, USA

name: National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan, Republic of China

name: Department of Rheumatology and Fraunhofer Institute IME, Translational Medicine and Pharmacology, Goethe University, Frankfurt am Main, Germany

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

name: Department of Medicine, University of Queensland, Rheumatology Research Unit Sunshine Coast, Queensland, Australia

ReferenceCitation: Nash P, Kirkham B, Okada M, Rahman P, Combe B, Burmester GR, Adams DH, Kerr L, Lee C, Shuler CL, Genovese M; SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017 Jun 10;389(10086):2317-2327. doi: 10.1016/S0140-6736(17)31429-0. Epub 2017 May 24.

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.

location_country:
Italy
United States
France
Czechia
Poland
Australia
Spain
Germany
United Kingdom
Taiwan

location_facility: Arthritis, Rheumatic & Back Disease Associates

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: Universität Leipzig - Universitätsklinikum

location_facility: Pennsylvania Regional Center for Arthritis & Osteoarthritis

location_facility: Azienda Ospedaliera - Universitaria Pisana

location_facility: Allergy Asthma Immunology of Rochester, AAIR Research Ctr

location_facility: Arthritis and Osteoporosis Consultants of the Carolinas

location_facility: Rheumatology Associates of South Florida

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Washington University School of Medicine

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: Basildon and Thurrock University Hospital

location_facility: Arthritis & Osteoporosis Treatment Center, PA

location_facility: Albuquerque Rehabilitation & Rheumatology, PC

location_facility: CHU de Montpellier-Hopital Arnaud de Villeneuve

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Hospital Regional Universitario de Málaga

location_facility: Clinical Research Center of Reading, LLC

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Krankenhaus Dresden-Friedrichstadt Städtisches Klinikum

location_facility: PV-MEDICAL s.r.o. Revmatologicka ambulance


ReferenceCitation: Weaver TE, Pepin JL, Schwab R, Shapiro C, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Bron M, Chandler P, Lee L, Malhotra A. Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021 Oct 1;17(10):1995-2007. doi: 10.5664/jcsm.9384.

name: College of Nursing, University of Illinois Chicago, Chicago, IL

family: Weaver

full_name: Terri E. Weaver

given: Terri E.

name: Grenoble Alpes University and INSERM, Grenoble, France

family: Pepin

full_name: Jean-Louis Pepin

given: Jean-Louis

name: University of Pennsylvania, Philadelphia, PA

family: Schwab

full_name: Richard Schwab

given: Richard

name: University of Toronto, Toronto, ON, Canada

family: Shapiro

full_name: Colin Shapiro

given: Colin

name: Sahlgrenska University Hospital, Gothenburg University, Gothenburg, Sweden

family: Hedner

full_name: Jan Hedner

given: Jan

name: Cleveland Sleep Research Center, Cleveland, OH

family: Ahmed

full_name: Mansoor Ahmed

given: Mansoor

name: Cleveland Clinic Lerner College of Medicine, Cleveland, OH

family: Foldvary-Schaefer

full_name: Nancy Foldvary-Schaefer

given: Nancy

name: University of Pittsburgh/Veterans Administration Pittsburgh Health System, Pittsburgh, PA

family: Strollo

full_name: Patrick J. Strollo

given: Patrick J.

suffix: Jr

family: Mayer

full_name: Geert Mayer

given: Geert

name: San Francisco Veterans Administration Health Care System, San Francisco, CA

family: Sarmiento

full_name: Kathleen Sarmiento

given: Kathleen

family: Baladi

full_name: Michelle Baladi

given: Michelle

family: Bron

full_name: Morgan Bron

given: Morgan

family: Chandler

full_name: Patricia Chandler

given: Patricia

family: Lee

full_name: Lawrence Lee

given: Lawrence

name: Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego, La Jolla, CA

family: Malhotra

full_name: Atul Malhotra

given: Atul

journal_name: Journal of Clinical Sleep Medicine

publisher: American Academy of Sleep Medicine (AASM)

ReferenceCitation: Schweitzer PK, Strohl KP, Mayer G, Rosenberg R, Chandler P, Baladi M, Lee L, Malhotra A. Effects of solriamfetol in a long-term trial of participants with obstructive sleep apnea who are adherent or nonadherent to airway therapy. J Clin Sleep Med. 2021 Apr 1;17(4):659-668. doi: 10.5664/jcsm.8992.

name: Sleep Medicine and Research Center, St. Luke’s Hospital, Chesterfield, Missouri

family: Schweitzer

full_name: Paula K. Schweitzer

given: Paula K.

name: Case Western Reserve University, Cleveland, Ohio

family: Strohl

full_name: Kingman P. Strohl

given: Kingman P.

name: NeuroTrials Research, Inc., Atlanta, Georgia

name: Atlanta School of Sleep Medicine, Atlanta, Georgia

family: Rosenberg

full_name: Russell Rosenberg

given: Russell

name: Jazz Pharmaceuticals, Palo Alto, California

name: Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego Medical Center, La Jolla, California

ReferenceCitation: Malhotra A, Shapiro C, Pepin JL, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Chandler P, Lee L, Schwab R. Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea. Sleep. 2020 Feb 13;43(2). pii: zsz220. doi: 10.1093/sleep/zsz220.

name: HP2 Laboratory, INSERM U1042, University Grenoble Alpes, France

name: EFCR Laboratory, Pole Thorax et Vaisseaux, Grenoble Alpes University Hospital, France

name: Sahlgrenska University Hospital, Gothenburg University, Sweden

name: Cleveland Clinic Lerner College of Medicine, OH

name: University of Pittsburgh/Veterans Administration Pittsburgh Health System, PA

name: San Francisco Veterans Administration Healthcare System, CA

repositories: California Digital Library - eScholarship

repositories_institution: University of California - eScholarship University of California

location_country:
United States
Netherlands
Finland
France
Germany
Canada

location_facility: Hickory Research Center, ARSM Research, LLC

location_facility: Center for Sleep and Circadian Neurobiology

location_facility: Sleep Medicine & Research center, St. Lukes Hospital

location_facility: University of Turku , Sleep Research Centre

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Henry Ford Hospital Sleep Disorders & Research Center

location_facility: Clinical Research Group of St. Petersburg

location_facility: The Research Center of Southern California

location_facility: So Cal Institute For Respiratory Diseases, Inc.

location_facility: Southwest Cleveland Sleep Research Center

location_facility: Sleep Med of South Carolina Clinical Research Solutions

location_facility: Mercy St. Anne & Mercy St. Charles Sleep Disorders Center

location_facility: Stanford University Center for Narcolepsy

location_facility: Critical care Pulmonary & Sleep Associates, LLC

location_facility: Ohio Sleep Medicine & Neuroscience Institute

location_facility: University of Illinois at Chicago Nursing School

title: A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea

summary: This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.


design_allocation: Non-Randomized

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Brazil
Hong Kong
Netherlands
Germany
France
Singapore
Belgium
Australia
Russian Federation
Spain
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: USC Kenneth Norris Comprehensive Cancer Center SC-3

location_facility: NKI-AVL, Department of Thoracic-Oncology

location_facility: The Ohio State University Comprehensive Cancer Center Ohio State University

ipd_sharing: Yes

source: euctr

title: A Phase II, Multi-center, Open-label, Five-arm Study to Evaluate the Efficacy and Safety of Oral Ceritinib Treatment for Patients With ALK-positive Non-small Cell Lung Cancer (NSCLC) Metastatic to the Brain and/or to Leptomeninges

summary: This was a phase II, multi-center, open-label, five-arm study in which the efficacy and safety of oral ceritinib treatment was assessed in patients with NSCLC metastatic to the brain and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA approved Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring algorithm (including positivity criteria). If documentation of ALK rearrangement as described above was not locally available, a test to confirm ALK rearrangement was performed by a Novartis designated central laboratory. Patients waited for the central laboratory result of the ALK rearrangement status before initiating treatment with ceritinib.


ReferenceCitation: Tolaney SM, Sahebjam S, Le Rhun E, Bachelot T, Kabos P, Awada A, Yardley D, Chan A, Conte P, Diéras V, Lin NU, Bear M, Chapman SC, Yang Z, Chen Y, Anders CK. A Phase II Study of Abemaciclib in Patients with Brain Metastases Secondary to Hormone Receptor-Positive Breast Cancer. Clin Cancer Res. 2020 Oct 15;26(20):5310-5319. doi: 10.1158/1078-0432.CCR-20-1764. Epub 2020 Jul 21. Erratum in: Clin Cancer Res. 2021 Mar 1;27(5):1582.

family: Tolaney

full_name: Sara M. Tolaney

given: Sara M.

family: Sahebjam

full_name: Solmaz Sahebjam

given: Solmaz

family: Le Rhun

full_name: Emilie Le Rhun

given: Emilie

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Kabos

full_name: Peter Kabos

given: Peter

family: Awada

full_name: Ahmad Awada

given: Ahmad

family: Yardley

full_name: Denise Yardley

given: Denise

family: Chan

full_name: Arlene Chan

given: Arlene

family: Conte

full_name: Pierfranco Conte

given: Pierfranco

family: Diéras

full_name: Véronique Diéras

given: Véronique

family: Lin

full_name: Nancy U. Lin

given: Nancy U.

family: Bear

full_name: Melissa Bear

given: Melissa

family: Chapman

full_name: Sonya C. Chapman

given: Sonya C.

family: Yang

full_name: Zhengyu Yang

given: Zhengyu

family: Chen

full_name: Yanyun Chen

given: Yanyun

family: Anders

full_name: Carey K. Anders

given: Carey K.

journal_name: Clinical Cancer Research

publisher: American Association for Cancer Research (AACR)

title: A Phase II Study of Abemaciclib in Patients with Brain Metastases Secondary to Hormone Receptor–Positive Breast Cancer

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Austria
United States
France
Israel
Australia
Belgium
Spain
Canada

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

location_facility: University of North Carolina at Chapel Hill

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Kaiser Permanente Center for Health Research

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

title: A Phase 2 Study of Abemaciclib in Patients With Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer, Non-small Cell Lung Cancer, or Melanoma

summary: The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as abemaciclib in participants with hormone receptor positive breast cancer, non-small cell lung cancer (NSCLC), or melanoma that has spread to the brain.


status: Recruiting

lead_sponsor: Amgen

enrollment_type: Anticipated

location_country:
Italy
Austria
United States
Switzerland
Netherlands
France
Israel
Australia
Spain
Denmark
Canada
United Kingdom

study_completion_date_type: Anticipated

title: Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

summary:
The purpose of Phase 1b of this study is to:

Asses the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL).
Determine the maximum tolerated dose (MTD) and to recommend a phase 2 dose of carfilzomib in combination with induction chemotherapy.

The purpose of Phase 2 of this study is to compare the rate of complete response (CR) of carfilzomib in combination with vincristine, dexamethasone, PEG asparaginase, daunorubicin (VXLD) at the end of induction therapy to an appropriate external control.

status_simplified: Ongoing


title: A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With Abatacept in Subjects With Active Ulcerative Colitis (UC) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy

summary: The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active ulcerative colitis in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied

ReferenceCitation: Sandborn WJ, Colombel JF, Sands BE, Rutgeerts P, Targan SR, Panaccione R, Bressler B, Geboes K, Schreiber S, Aranda R, Gujrathi S, Luo A, Peng Y, Salter-Cid L, Hanauer SB. Abatacept for Crohn's disease and ulcerative colitis. Gastroenterology. 2012 Jul;143(1):62-69.e4. doi: 10.1053/j.gastro.2012.04.010. Epub 2012 Apr 12.

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Colombel

full_name: Jean–Frederic Colombel

given: Jean–Frederic

family: Sands

full_name: Bruce E. Sands

given: Bruce E.

family: Rutgeerts

full_name: Paul Rutgeerts

given: Paul

family: Targan

full_name: Stephan R. Targan

given: Stephan R.

family: Panaccione

full_name: Remo Panaccione

given: Remo

family: Bressler

full_name: Brian Bressler

given: Brian

family: Geboes

full_name: Karl Geboes

given: Karl

family: Schreiber

full_name: Stefan Schreiber

given: Stefan

family: Aranda

full_name: Richard Aranda

given: Richard

family: Gujrathi

full_name: Sheila Gujrathi

given: Sheila

family: Luo

full_name: Allison Luo

given: Allison

family: Peng

full_name: Yun Peng

given: Yun

family: Salter–Cid

full_name: Luisa Salter–Cid

given: Luisa

family: Hanauer

full_name: Stephen B. Hanauer

given: Stephen B.

journal_name: Gastroenterology

title: Abatacept for Crohn's Disease and Ulcerative Colitis

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
Brazil
South Africa
India
Switzerland
Mexico
Netherlands
Germany
United Kingdom
France
Poland
Ireland
Belgium
Australia
Puerto Rico
Canada
Czech Republic
Korea, Republic of

location_facility: Gastrointestinal & Liver Diseases Consultants

location_facility: Oklahoma Foundation For Digestive Research

location_facility: Hospital Of The University Of Pennsylvania

location_facility: Center For Digestive & Liver Diseases, Inc.

location_facility: Litchfield County Gastroenterology Assoc.

location_facility: Gastroenterology Center Of The Midsouth, P.C.

location_facility: University Of Kentucky Chandler Medical Center

location_facility: Charlotte Gastroenterology & Hepatology, Pllc

location_facility: Kansas City Gastroenterology And Hepatology


title: Duloxetine Versus Placebo in the Long-Term Treatment of Patients With Late-Life Major Depression

summary: The purpose of this study is to compare the efficacy and safety of duloxetine 60 mg once daily to placebo on depression in elderly patients (greater than or equal to 65 years of age). Patients who do not respond in the first 13 weeks will be eligible for rescue using pre-defined criteria. Patients randomized to duloxetine 60 mg/day meeting the rescue criteria will be increased to 120 mg/day. Patients randomized to the placebo arm meeting the rescue criteria will be assigned to duloxetine 60 mg/day.

ReferenceCitation: Harada E, Kato M, Fujikoshi S, Wohlreich MM, Berggren L, Tokuoka H. Changes in energy during treatment of depression: an analysis of duloxetine in double-blind placebo-controlled trials. Int J Clin Pract. 2015 Oct;69(10):1139-48. doi: 10.1111/ijcp.12658. Epub 2015 May 16.

name: Medical Science Eli Lilly Japan K.K. Hyogo Japan

family: Harada

full_name: E. Harada

given: E.

name: Department of Neuropsychiatry Kansai Medical University Osaka Japan

family: Kato

full_name: M. Kato

given: M.

name: Statistical Science Eli Lilly Japan K.K. Hyogo Japan

family: Fujikoshi

full_name: S. Fujikoshi

given: S.

name: Neuroscience Eli Lilly and Company Indianapolis IN USA

family: Wohlreich

full_name: M. M. Wohlreich

given: M. M.

name: Global Statistical Sciences Eli Lilly and Company Bad Homburg Germany

family: Berggren

full_name: L. Berggren

given: L.

family: Tokuoka

full_name: H. Tokuoka

given: H.

journal_name: International Journal of Clinical Practice

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: PubMed Central - Europe PMC

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Changes in energy during treatment of depression: an analysis of duloxetine in double‐blind placebo‐controlled trials

ReferenceCitation: Nelson JC, Oakes TM, Liu P, Ahl J, Bangs ME, Raskin J, Perahia DG, Robinson MJ. Assessment of falls in older patients treated with duloxetine: a secondary analysis of a 24-week randomized, placebo-controlled trial. Prim Care Companion CNS Disord. 2013;15(1). pii: PCC.12m01419. doi: 10.4088/PCC.12m01419. Epub 2012 Jan 3.

family: Nelson

full_name: J. Craig Nelson

given: J. Craig

family: Oakes

full_name: Tina M. M. Oakes

given: Tina M. M.

family: Liu

full_name: Peng Liu

given: Peng

family: Ahl

full_name: Jonna Ahl

given: Jonna

family: Bangs

full_name: Mark E. Bangs

given: Mark E.

family: Raskin

full_name: Joel Raskin

given: Joel

family: Perahia

full_name: David G. Perahia

given: David G.

family: Robinson

full_name: Michael J. Robinson

given: Michael J.

journal_name: The Primary Care Companion For CNS Disorders

oa_host_type: repository

title: Assessment of Falls in Older Patients Treated With Duloxetine

ReferenceCitation: Oakes TM, Katona C, Liu P, Robinson M, Raskin J, Greist JH. Safety and tolerability of duloxetine in elderly patients with major depressive disorder: a pooled analysis of two placebo-controlled studies. Int Clin Psychopharmacol. 2013 Jan;28(1):1-11. doi: 10.1097/YIC.0b013e32835b09cd.

publisher: Ovid Technologies (Wolters Kluwer Health)


ReferenceCitation: Platt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer. 2015 Mar 23;15:171. doi: 10.1186/s12885-015-1146-8.

family: Platt

full_name: Adam Platt

given: Adam

family: Morten

full_name: John Morten

given: John

family: Ji

full_name: Qunsheng Ji

given: Qunsheng

family: Elvin

full_name: Paul Elvin

given: Paul

family: Womack

full_name: Chris Womack

given: Chris

family: Su

full_name: Xinying Su

given: Xinying

family: Donald

full_name: Emma Donald

given: Emma

family: Gray

full_name: Neil Gray

given: Neil

family: Read

full_name: Jessica Read

given: Jessica

family: Bigley

full_name: Graham Bigley

given: Graham

family: Blockley

full_name: Laura Blockley

given: Laura

family: Cresswell

full_name: Carl Cresswell

given: Carl

family: Dale

full_name: Angela Dale

given: Angela

family: Davies

full_name: Amanda Davies

given: Amanda

family: Zhang

full_name: Tianwei Zhang

given: Tianwei

family: Fan

full_name: Shuqiong Fan

given: Shuqiong

family: Fu

full_name: Haihua Fu

given: Haihua

family: Gladwin

full_name: Amanda Gladwin

family: Harrod

full_name: Grace Harrod

given: Grace

family: Stevens

full_name: James Stevens

given: James

family: Williams

full_name: Victoria Williams

given: Victoria

family: Ye

full_name: Qingqing Ye

given: Qingqing

family: Zheng

full_name: Li Zheng

given: Li

family: de Boer

full_name: Richard de Boer

given: Richard

family: Herbst

full_name: Roy S Herbst

given: Roy S

location_country:
Peru
Australia
Belgium
Taiwan
France
Thailand
Argentina
Canada
Korea, Republic of
Hong Kong
Netherlands
Philippines
Singapore
China
Germany
United States
United Kingdom
Italy
Austria
Mexico
Israel
Spain

title: A Phase III Study to Assess the Efficacy of ZD6474 (ZACTIMA™) Plus Best Supportive Care Versus Best Supportive Care in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer After Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI)

summary: This study is being carried out to assess if adding ZD6474 to best supportive care (BSC) is more effective than best supportive care alone, for the treatment of patients with non-small cell lung cancer, whose disease has recurred after previous chemotherapy and an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI). ZD6474 is a new anti-cancer drug in development that works in a different way to standard chemotherapy drugs. It targets the growth of new blood vessels to a tumour and thereby might slow the rate at which the tumour may grow. Early studies indicate that ZD6474 has a positive effect on the time that a tumour may take to progress to a further stage. Approximately 930 patients will take part in this study. It will be conducted in hospitals and clinics in North and South America, Europe and Asia.


lead_sponsor: Pfizer

location_country:
Italy
France
Poland
Belgium
Australia
Spain
Denmark
United Kingdom

title: Phase 2 Single-Arm, Open Label Study Of Irinotecan In Combination With Temozolomide In Children With Recurrent Or Refractory Medulloblastoma And In Children With Newly Diagnosed High-Grade Glioma.

summary: This study will assess the rate of objective confirmed tumor response of irinotecan in combination with temozolomide in children with recurrent or refractory medulloblastoma and in children with newly diagnosed high-grade glioma.


title: SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions

acronym: SPIRIT V

summary: The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions.

ReferenceCitation: Généreux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5). pii: e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.

name: From the Columbia University Medical Center, New York, NY (P.G., G.W.S.); Cardiovascular Research Foundation, New York, NY (P.G., G.W.S.); Hôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, Quebec, Canada (P.G.); Abbott Vascular, Santa Clara, CA (D.R.R., J.W., J.J.-M., K.S., C.A.S.); Istituto di Cardiologia, University of Bologna, Italy (T.P.); Escola Paulista de Medicina, Universidade Federal de São Paulo and Hospital Israelita Albert Einstein, São Paolo, Brazil (A.C.); Isala...

family: Généreux

full_name: Philippe Généreux

given: Philippe

family: Rutledge

full_name: David R. Rutledge

given: David R.

family: Palmerini

full_name: Tullio Palmerini

given: Tullio

family: Caixeta

full_name: Adriano Caixeta

given: Adriano

family: Kedhi

full_name: Elvin Kedhi

given: Elvin

family: Hermiller

full_name: James B. Hermiller

given: James B.

family: Wang

full_name: Jin Wang

given: Jin

family: Krucoff

full_name: Mitchell W. Krucoff

given: Mitchell W.

family: Jones-McMeans

full_name: Jennifer Jones-McMeans

given: Jennifer

family: Sudhir

full_name: Krishnankutty Sudhir

given: Krishnankutty

family: Simonton

full_name: Charles A. Simonton

given: Charles A.

family: Serruys

full_name: Patrick W. Serruys

given: Patrick W.

family: Stone

full_name: Gregg W. Stone

given: Gregg W.

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Ringel RE, Gauvreau K, Moses H, Jenkins KJ. Coarctation of the Aorta Stent Trial (COAST): study design and rationale. Am Heart J. 2012 Jul;164(1):7-13. doi: 10.1016/j.ahj.2012.04.008. Epub 2012 Jun 20.

family: Ringel

full_name: Richard E. Ringel

given: Richard E.

family: Gauvreau

full_name: Kimberlee Gauvreau

given: Kimberlee

family: Moses

full_name: Heidi Moses

given: Heidi

family: Jenkins

full_name: Kathy J. Jenkins

given: Kathy J.

journal_name: American Heart Journal

title: Coarctation of the Aorta Stent Trial (COAST): Study design and rationale

ReferenceCitation: Grube E, Chevalier B, Guagliumi G, Smits PC, Stuteville M, Dorange C, Papeleu P, Kaul U, Džavík V. The SPIRIT V diabetic study: a randomized clinical evaluation of the XIENCE V everolimus-eluting stent vs the TAXUS Liberté paclitaxel-eluting stent in diabetic patients with de novo coronary artery lesions. Am Heart J. 2012 May;163(5):867-875.e1. doi: 10.1016/j.ahj.2012.02.006. Epub 2012 Apr 11.

family: Grube

title: The SPIRIT V Diabetic Study: A randomized clinical evaluation of the XIENCE V everolimus-eluting stent vs the TAXUS Liberté paclitaxel-eluting stent in diabetic patients with de novo coronary artery lesions

location_country:
Malaysia
Greece
Belgium
Czech Republic
India
France
Thailand
Canada
South Africa
Sweden
Switzerland
Netherlands
Singapore
Ireland
China
Portugal
Germany
United Kingdom
Italy
Austria
Israel
New Zealand
Spain

location_facility: Emodinamica Cardiologia Azienda ULSS 12 Veneziana, Ospedale Civile Umberto 1

location_facility: Hadassah-Hebrew University Medical Center

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: All India Institute of Medical Science - AIIMS

location_facility: University health Network - Toronto Gen Hospital

location_facility: Institute of Cardiovascular Disease M.M.M.


title: Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis The Einstein-DVT Dose-finding Study. A Phase II Evaluation.

summary: The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the safety and effectiveness of this new drug with the standard way of treatment of deep vein thrombosis (heparin infusion plus one of the vitamin K antagonists), taking into account new events of thrombosis and pulmonary embolism and bleeding risk.

ReferenceCitation: Buller HR, Lensing AW, Prins MH, Agnelli G, Cohen A, Gallus AS, Misselwitz F, Raskob G, Schellong S, Segers A; Einstein-DVT Dose-Ranging Study investigators. A dose-ranging study evaluating once-daily oral administration of the factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein-DVT Dose-Ranging Study. Blood. 2008 Sep 15;112(6):2242-7. doi: 10.1182/blood-2008-05-160143. Epub 2008 Jul 11.

name: Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands;

family: Buller

full_name: Harry R. Buller

given: Harry R.

family: Lensing

full_name: Anthonie W. A. Lensing

given: Anthonie W. A.

name: Department of Epidemiology, Care and Public Health Research Institute, University of Maastricht and Department of Clinical Epidemiology and Medical Technology Assessment, Academic Hospital Maastricht, Maastricht, The Netherlands;

family: Prins

full_name: Martin H. Prins

given: Martin H.

name: Institute of Internal and Vascular Medicine, University of Perugia, Perugia, Italy;

family: Agnelli

full_name: Giancarlo Agnelli

given: Giancarlo

name: Kings College School of Medicine & Dentistry, London, United Kingdom;

family: Cohen

full_name: Alexander Cohen

given: Alexander

name: Department of Hematology, Flinders Medical Center, Bedford Park, Australia;

family: Gallus

full_name: Alexander S. Gallus

given: Alexander S.

family: Misselwitz

full_name: Frank Misselwitz

given: Frank

name: College of Public Health, University of Oklahoma, Oklahoma City;

family: Raskob

full_name: Gary Raskob

given: Gary

name: Universitaetsklinikum Carl Gustav Carus, Dresden, Germany; and

family: Schellong

full_name: Sebastian Schellong

given: Sebastian

name: International Clinical Trial Organization and Management, Amsterdam, The Netherlands

family: Segers

full_name: Annelise Segers

given: Annelise

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

title: A dose-ranging study evaluating once-daily oral administration of the factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein–DVT Dose-Ranging Study

lead_sponsor: Bayer

location_country:
Italy
Brazil
United States
South Africa
Sweden
Netherlands
France
Poland
Israel
Australia
Denmark
Canada
Czech Republic


title: Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months Administration of SB-683699 in Subjects With Relapsing-Remitting Multiple Sclerosis

summary: SB-683699 is an oral medication that is thought to reduce the number of active white blood cells entering the brain; these white blood cells are part of the disease process for MS. This study will look at whether different doses of SB-683699 are effective and safe in patients with relapsing remitting MS.

ReferenceCitation: Miller DH, Weber T, Grove R, Wardell C, Horrigan J, Graff O, Atkinson G, Dua P, Yousry T, Macmanus D, Montalban X. Firategrast for relapsing remitting multiple sclerosis: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2012 Feb;11(2):131-9. doi: 10.1016/S1474-4422(11)70299-X. Epub 2012 Jan 5.

family: Miller

full_name: David H Miller

given: David H

family: Weber

full_name: Thomas Weber

given: Thomas

family: Grove

full_name: Richard Grove

given: Richard

family: Wardell

full_name: Claire Wardell

given: Claire

family: Horrigan

full_name: Joseph Horrigan

given: Joseph

family: Graff

full_name: Ole Graff

given: Ole

family: Atkinson

full_name: Gillian Atkinson

given: Gillian

family: Dua

full_name: Pinky Dua

given: Pinky

family: Yousry

full_name: Tarek Yousry

given: Tarek

family: MacManus

full_name: David MacManus

given: David

family: Montalban

full_name: Xavier Montalban

given: Xavier

journal_name: The Lancet Neurology

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Austria
Netherlands
Germany
Finland
France
Poland
Norway
Australia
Russian Federation
New Zealand
Spain
Canada
United Kingdom

intervention_type: Other


title: Phase III Randomized, Multi Center Study Of Sunitinib Malate (SU 011248) Or Capecitabine In Subjects With Advanced Breast Cancer Who Failed Both A Taxane And An Anthracycline Chemotherapy Regimen Or Failed With A Taxane And For Whom Further Anthracycline Therapy Is Not Indicated

summary: To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated

location_country:
Peru
Australia
Taiwan
India
France
Japan
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Hong Kong
Philippines
Bulgaria
Singapore
Germany
United Kingdom
Italy
Brazil
Mexico
Spain
Turkey

status_simplified: Unknown


title: A Phase II Open Label, Randomized, 3 Arm Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab as First Line Therapy for Locally Recurrent or Metastatic Breast Cancer

summary: The purpose of this clinical research study is to learn if ixabepilone plus bevacizumab is effective in shrinking or stopping the growth of cancer when given as first-line chemotherapy in participants with metastatic breast cancer. The study will also assess the safety of this combination treatment.

lead_sponsor: R-Pharm

location_country:
Italy
France
Spain
United States
United Kingdom

location_facility: Weill Medical College Of Cornell University

location_facility: East Valley Hematology And Oncology Medical Group

location_facility: University Of Iowa Hospitals And Clinics


title: A Multi-Center, Phase 2, Open-Label Study of (RS)-10-Propargyl-10-Deazaaminopterin (Pralatrexate) With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

acronym: PROPEL

summary:
Primary

• Determine the efficacy of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)

Secondary

Determine the safety of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory PTCL
Determine the pharmacokinetic (PK) profile of pralatrexate when administered with vitamin B12 and folic acid supplementation

lead_sponsor: Acrotech Biopharma LLC

location_country:
Italy
United States
France
Belgium
Canada
United Kingdom

location_facility: The Cancer Center at Hackensack University Medical Center

location_facility: Ospedale Sant'Orsola - Policlinico Sant'Orsola

location_facility: Washington University School of Medicine

location_facility: University of Iowa Hospitals and Clinics


title: A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who Are Asymptomatic or Minimally Symptomatic

summary: The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.

location_country:
Italy
United States
Chile
Netherlands
France
Australia
Spain
Germany
United Kingdom

location_facility: University of Pittsburgh Cancer Institute Cancer Services

location_facility: George Washington University Medical Center

location_facility: Urologische Gemeinschaftspraxis Dres Stammel U. Garcia

location_facility: Istituto Nazionale Tumori Fondazione Pascale


ReferenceCitation: Sehn LH, Hertzberg M, Opat SS, Herrera AF, Assouline S, Flowers CR, Kim TM, McMillan AK, Özcan M, Safar V, Salles GA, Ku G, Hirata J, Chang YM, Musick L, Matasar MJ. Polatuzumab vedotin plus bendamustine and rituximab in relapsed/refractory DLBCL: survival update and new extension cohort. Blood Adv. 2021 Nov 8. pii: bloodadvances.2021005794. doi: 10.1182/bloodadvances.2021005794. [Epub ahead of print]

family: Sehn

full_name: Laurie H. Sehn

given: Laurie H.

name: Prince of Wales Hospital, Randwick, Australia

family: Hertzberg

full_name: Mark Hertzberg

given: Mark

family: Opat

full_name: Stephen S. Opat

given: Stephen S.

name: City of Hope National Medical Center, Duarte, California, United States

family: Herrera

full_name: Alex F. Herrera

given: Alex F.

name: Jewish General Hospital, McGill University, Montreal, Canada

family: Assouline

full_name: Sarit Assouline

given: Sarit

name: University of Texas MD Anderson Cancer Center, Houston, Texas, United States

family: Flowers

full_name: Christopher R. Flowers

given: Christopher R.

name: Seoul National University Hospital, Seoul, Korea, Republic of

family: Kim

full_name: Tae Min Kim

given: Tae Min

name: Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom

family: McMillan

full_name: Andrew K McMillan

given: Andrew K

name: Ankara University School of Medicine, Ankara, Turkey

family: Özcan

full_name: Muhit Özcan

given: Muhit

name: Hospices Civils de Lyon, Pierre-Bénite, France

family: Safar

full_name: Violaine Safar

given: Violaine

family: Salles

full_name: Gilles Andre Salles

given: Gilles Andre

name: Genentech, Inc., South San Francisco, California, United States

family: Ku

full_name: Grace Ku

given: Grace

family: Hirata

full_name: Jamie Hirata

given: Jamie

name: F. Hoffmann-La Roche Ltd, Mississauga, Canada

family: Chang

full_name: Yi Meng Chang

given: Yi Meng

family: Musick

full_name: Lisa Musick

given: Lisa

name: Memorial Sloan-Kettering Cancer Center, New York, New York, United States

family: Matasar

full_name: Matthew J. Matasar

given: Matthew J.

journal_name: Blood Advances

evidence: open (via free article)

ReferenceCitation: Betts KA, Thuresson PO, Felizzi F, Du EX, Dieye I, Li J, Schulz M, Masaquel AS. US cost-effectiveness of polatuzumab vedotin, bendamustine and rituximab in diffuse large B-cell lymphoma. J Comp Eff Res. 2020 Oct;9(14):1003-1015. doi: 10.2217/cer-2020-0057. Epub 2020 Oct 8. Erratum in: J Comp Eff Res. 2021 Mar;10(4):337.

name: Analysis Group, Inc., Los Angeles, CA 90071, USA

family: Betts

full_name: Keith A Betts

given: Keith A

name: F. Hoffmann-La Roche Ltd, Basel, Switzerland

family: Thuresson

full_name: Per-Olof Thuresson

given: Per-Olof

family: Felizzi

full_name: Federico Felizzi

given: Federico

family: Du

full_name: Ella X Du

given: Ella X

name: Analysis Group, Inc., Boston, MA 02199, USA

family: Dieye

full_name: Ibou Dieye

given: Ibou

name: Genentech, Inc., South San Francisco, CA 94080, USA

journal_name: Journal of Comparative Effectiveness Research

title: US cost–effectiveness of polatuzumab vedotin, bendamustine and rituximab in diffuse large B-cell lymphoma

ReferenceCitation: Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8.

ReferenceCitation: Lu T, Gibiansky L, Li X, Li C, Shi R, Agarwal P, Hirata J, Miles D, Chanu P, Girish S, Jin JY, Lu D. Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2020 Dec;61(12):2905-2914. doi: 10.1080/10428194.2020.1795154. Epub 2020 Jul 24.

name: Genentech, Inc, South San Francisco, CA, USA

name: Genentech, Inc./F. Hoffmann-La Roche Ltd, Lyon, France

ReferenceCitation: Sehn LH, Herrera AF, Flowers CR, Kamdar MK, McMillan A, Hertzberg M, Assouline S, Kim TM, Kim WS, Ozcan M, Hirata J, Penuel E, Paulson JN, Cheng J, Ku G, Matasar MJ. Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2020 Jan 10;38(2):155-165. doi: 10.1200/JCO.19.00172. Epub 2019 Nov 6.

name: BC Cancer Centre for Lymphoid Cancer and The University of British Columbia, Vancouver, British Columbia, Canada

name: Winship Cancer Institute of Emory University, Atlanta, GA

name: Nottingham University Hospitals, Nottingham, United Kingdom

name: Prince of Wales Hospital and University of NSW, Sydney, NSW, Australia

name: Jewish General Hospital, Montreal, Quebec, Canada

name: Seoul National University Hospital, Seoul, South Korea

name: Samsung Medical Center, Seoul, South Korea

name: F. Hoffman-La Roche, Mississauga, Ontario, Canada

name: Memorial Sloan Kettering Cancer Center, New York, NY

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

location_country:
Italy
United States
Netherlands
Germany
France
Czechia
Hungary
Australia
Spain
Turkey
Canada
United Kingdom
Korea, Republic of

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Semmelweis University, First Dept of Medicine

location_facility: Hospital Clinic i Provincial de Barcelona; Hematology

location_facility: Klinik der Uni Regensburg; Hämatologie/Onkologie, Studienzentrale

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Southampton General Hospital; Somers Cancer Research Building

location_facility: Karadeniz Technical Uni School of Medicine; Hematology

location_facility: Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Hämatologie, Onkologie und Pallia.

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: National Institute of Oncology, A Dept of Internal Medicine

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Abt. für Hämatologie und Onkologie

location_facility: Fakultní nemocnice Ostrava Klinika hematoonkologie

location_facility: Ondokuzmayis University Medical Faculty Heamatology Department

location_facility: HELIOS Klinikum Erfurt - Innere Medizin - 4. Medizinische Klinik, Hämatologie

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

location_facility: Regional Cancer Care Associates LLC - Morristown

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: CHU Saint Eloi; Service d'Hématologie Clinique

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: University of Debrecen Medical and Health Science Center, Institute of Internal medicine Building B

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: I Interni klinika; Vseobecna fakultni nemocnice

location_facility: Joliet Oncology-Hematology; Associates, Ltd.

location_facility: Monash Medical Centre; Haematology Research

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica

location_facility: KING'S COLLEGE HOSPITAL; Commercial R&D Amendments, King's Health Partner's Clinical Trials Office

title: A Phase IB/II Study Evaluating The Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin in Combination With Rituximab (R) or Obinutuzumab (G) Plus Bendamustine (B) in Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

summary: This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with standard doses of bendamustine (B) and rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a Phase Ib safety run-in stage and a Phase II stage. The anticipated time on treatment is 18 weeks for participants with DLBCL and 24 weeks for participants with FL.


title: Study DB2116961, A Multicentre, Randomised, Blinded, Parallel Group Study to Compare UMEC/VI (Umeclidinium/Vilanterol) in a Fixed Dose Combination With Indacaterol Plus Tiotropium in Symptomatic Subjects With Moderate to Very Severe COPD

summary: This is a Phase IIIb multicentre, randomised, blinded, triple dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI inhalation powder (62.5/25 microgram [mcg] Once daily [QD]) when administered via ELLIPTA® Dry Powder Inhaler (DPI) compared to indacaterol plus tiotropium (150 mcg/18 mcg respectively QD) administered via individual inhalers over a treatment period of 12 weeks in participants with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to demonstrate that UMEC/VI (delivered via ELLIPTA DPI), when used in symptomatic moderate to very severe COPD participants, is non-inferior to the combination of indacaterol (delivered via BREEZHALER® inhaler) plus tiotropium (delivered via HANDIHALER® inhaler) on measures of trough forced expiratory volume in one second (FEV1) after 12 weeks of treatment. Participants who met the eligibility criteria at screening (Visit 1) will complete a 5 to 7 day run in period prior to randomisation at Visit 2. Clinic visits will follow at day 2, week 2, week 4, week 8 and week 12 of treatment, plus week 12 + 1 day (Visits 3 to 8). The total duration of study participation will be approximately 14 weeks. ELLIPTA is a registered trademark of the GSK group of companies. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG. BREEZHALER is a registered trademark of Novartis AG.

ReferenceCitation: Kalberg C, O'Dell D, Galkin D, Newlands A, Fahy WA. Dual Bronchodilator Therapy with Umeclidinium/Vilanterol Versus Tiotropium plus Indacaterol in Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Drugs R D. 2016 Jun;16(2):217-27. doi: 10.1007/s40268-016-0131-2.

family: Kalberg

full_name: Chris Kalberg

given: Chris

family: O’Dell

full_name: Dianne O’Dell

given: Dianne

family: Galkin

full_name: Dmitry Galkin

given: Dmitry

family: Newlands

full_name: Amy Newlands

given: Amy

family: Fahy

full_name: William A. Fahy

given: William A.

journal_name: Drugs in R&D

license: cc-by-nc

license_normalized: cc-by-nc

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

location_country:
Italy
Chile
Peru
France
Poland
Slovakia
Romania
Hungary
Argentina
Russian Federation
Estonia
Germany


title: A Phase 2, Randomized, Double-Blind Study Exploring the Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine Plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects Currently Being Treated With Adefovir Dipivoxil for Chronic Hepatitis B and Having Persistent Viral Replication

summary:
This study explores the efficacy, safety and tolerability of tenofovir DF (TDF) 300 mg once daily monotherapy versus the combination of emtricitabine 200 mg plus tenofovir DF 300 mg (FTC/TDF) once daily in subjects currently being treated with adefovir dipivoxil (Hepsera) for chronic hepatitis B who have persistent viral replication (detectable hepatitis B virus deoxyribonucleic acid [HBV DNA]).

Subjects with confirmed (within 4 weeks) plasma HBV DNA ≥ 400 copies/mL during double blind treatment at Week 24 or any time thereafter have the option of receiving 12 weeks of open-label FTC/TDF which may be continued through the end of the 168-week treatment period if there is a virologic response (HBV DNA < 400 copies/mL). Alternatively, subjects with confirmed HBV DNA < 400 copies/mL at or any time after Week 24 of double-blind treatment may continue blinded therapy up to Week 168 at the discretion of the investigator. If, in the investigator's opinion, it is felt that continued blinded treatment beyond 24 weeks in subjects with confirmed HBV DNA ≥ 400 copies/mL is not beneficial, the subject may discontinue the study and begin commercially available HBV therapy rather than initiate open-label FTC/TDF.

ReferenceType: result

ReferenceCitation: van Bömmel F, Zöllner B, Sarrazin C, Spengler U, Hüppe D, Möller B, Feucht HH, Wiedenmann B, Berg T. Tenofovir for patients with lamivudine-resistant hepatitis B virus (HBV) infection and high HBV DNA level during adefovir therapy. Hepatology. 2006 Aug;44(2):318-25.

ReferenceCitation: Marcellin P, Heathcote EJ, Buti M, Gane E, de Man RA, Krastev Z, Germanidis G, Lee SS, Flisiak R, Kaita K, Manns M, Kotzev I, Tchernev K, Buggisch P, Weilert F, Kurdas OO, Shiffman ML, Trinh H, Washington MK, Sorbel J, Anderson J, Snow-Lampart A, Mondou E, Quinn J, Rousseau F. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med. 2008 Dec 4;359(23):2442-55. doi: 10.1056/NEJMoa0802878.

family: Marcellin

full_name: Patrick Marcellin

given: Patrick

family: Heathcote

full_name: E. Jenny Heathcote

given: E. Jenny

family: Buti

full_name: Maria Buti

given: Maria

family: Gane

full_name: Ed Gane

given: Ed

family: de Man

full_name: Robert A. de Man

given: Robert A.

family: Krastev

full_name: Zahary Krastev

given: Zahary

family: Germanidis

full_name: George Germanidis

given: George

family: Lee

full_name: Sam S. Lee

given: Sam S.

family: Flisiak

full_name: Robert Flisiak

given: Robert

family: Kaita

full_name: Kelly Kaita

given: Kelly

family: Manns

full_name: Michael Manns

given: Michael

family: Kotzev

full_name: Iskren Kotzev

given: Iskren

family: Tchernev

full_name: Konstantin Tchernev

given: Konstantin

family: Buggisch

full_name: Peter Buggisch

given: Peter

family: Weilert

full_name: Frank Weilert

given: Frank

family: Kurdas

full_name: Oya Ovung Kurdas

given: Oya Ovung

family: Shiffman

full_name: Mitchell L. Shiffman

given: Mitchell L.

family: Trinh

full_name: Huy Trinh

given: Huy

family: Washington

full_name: Mary Kay Washington

given: Mary Kay

family: Sorbel

full_name: Jeff Sorbel

given: Jeff

family: Anderson

full_name: Jane Anderson

given: Jane

family: Snow-Lampart

full_name: Andrea Snow-Lampart

given: Andrea

family: Mondou

full_name: Elsa Mondou

given: Elsa

title: Tenofovir Disoproxil Fumarate versus Adefovir Dipivoxil for Chronic Hepatitis B

ReferenceCitation: Reijnders JG, Janssen HL. Potency of tenofovir in chronic hepatitis B: mono or combination therapy? J Hepatol. 2008 Mar;48(3):383-6. doi: 10.1016/j.jhep.2007.12.006. Epub 2007 Dec 31.

title: Potency of tenofovir in chronic hepatitis B: Mono or combination therapy?

ReferenceCitation: Tan J, Degertekin B, Wong SN, Husain M, Oberhelman K, Lok AS. Tenofovir monotherapy is effective in hepatitis B patients with antiviral treatment failure to adefovir in the absence of adefovir-resistant mutations. J Hepatol. 2008 Mar;48(3):391-8. doi: 10.1016/j.jhep.2007.09.020. Epub 2008 Jan 3.

ReferenceCitation: van Bömmel F, de Man RA, Wedemeyer H, Deterding K, Petersen J, Buggisch P, Erhardt A, Hüppe D, Stein K, Trojan J, Sarrazin C, Böcher WO, Spengler U, Wasmuth HE, Reinders JG, Möller B, Rhode P, Feucht HH, Wiedenmann B, Berg T. Long-term efficacy of tenofovir monotherapy for hepatitis B virus-monoinfected patients after failure of nucleoside/nucleotide analogues. Hepatology. 2010 Jan;51(1):73-80. doi: 10.1002/hep.23246.

ReferenceCitation: Berg T, Marcellin P, Zoulim F, Moller B, Trinh H, Chan S, Suarez E, Lavocat F, Snow-Lampart A, Frederick D, Sorbel J, Borroto-Esoda K, Oldach D, Rousseau F. Tenofovir is effective alone or with emtricitabine in adefovir-treated patients with chronic-hepatitis B virus infection. Gastroenterology. 2010 Oct;139(4):1207-17. doi: 10.1053/j.gastro.2010.06.053. Epub 2010 Jun 20.

title: Tenofovir Is Effective Alone or With Emtricitabine in Adefovir-Treated Patients With Chronic-Hepatitis B Virus Infection


title: A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)

summary: A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel plus or minus sorafenib in chemonaive patients with stage III-IV non-small cell lung cancer.

ReferenceCitation: Scagliotti G, Novello S, von Pawel J, Reck M, Pereira JR, Thomas M, Abrão Miziara JE, Balint B, De Marinis F, Keller A, Arén O, Csollak M, Albert I, Barrios CH, Grossi F, Krzakowski M, Cupit L, Cihon F, Dimatteo S, Hanna N. Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer. J Clin Oncol. 2010 Apr 10;28(11):1835-42. doi: 10.1200/JCO.2009.26.1321. Epub 2010 Mar 8.

name: From the University of Turin, Torino; San Camillo-Forlanini Hospitals, Rome; Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy; Asklepios-Fachkliniken Munchen-Gauting, Gauting; Hospital Grosshansdorf, Grosshansdorf; University of Münster, Münster, Germany; Instituto Arnaldo Vieira de Carvalho; Hospital de Cancer de Barretos, São Paulo; Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil; Csongrad County Council's Hospital for Chest Diseases, Deszk;...

family: Scagliotti

full_name: Giorgio Scagliotti

given: Giorgio

family: Novello

full_name: Silvia Novello

given: Silvia

family: von Pawel

full_name: Joachim von Pawel

given: Joachim

family: Reck

full_name: Martin Reck

given: Martin

family: Pereira

full_name: José Rodrigues Pereira

given: José Rodrigues

family: Thomas

full_name: Michael Thomas

family: Abrão Miziara

full_name: José Elias Abrão Miziara

given: José Elias

family: Balint

full_name: Beatrix Balint

given: Beatrix

family: De Marinis

full_name: Filippo De Marinis

given: Filippo

family: Keller

full_name: Alan Keller

given: Alan

family: Arén

full_name: Osvaldo Arén

given: Osvaldo

family: Csollak

full_name: Maria Csollak

given: Maria

family: Albert

full_name: Istvan Albert

given: Istvan

family: Barrios

full_name: Carlos Henrique Barrios

given: Carlos Henrique

family: Grossi

full_name: Francesco Grossi

given: Francesco

family: Krzakowski

full_name: Maciej Krzakowski

given: Maciej

family: Cupit

full_name: Lisa Cupit

given: Lisa

family: Cihon

full_name: Frank Cihon

family: DiMatteo

full_name: Sandra DiMatteo

given: Sandra

family: Hanna

full_name: Nasser Hanna

given: Nasser

journal_name: Journal of Clinical Oncology

title: Phase III Study of Carboplatin and Paclitaxel Alone or With Sorafenib in Advanced Non–Small-Cell Lung Cancer

location_country:
Belgium
Australia
Russian Federation
Taiwan
France
Poland
Argentina
Canada
Korea, Republic of
Chile
Sweden
Hong Kong
Netherlands
Hungary
Puerto Rico
Germany
United States
United Kingdom
Italy
Brazil
Spain


title: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes

summary: This is a 12-week randomized, double-blind, multi-center, active-controlled (open-label pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 2-week enrollment period, 4 week placebo single blind run in period followed by a 12-week double blind treatment period and a 3-week follow-up period

ReferenceCitation: Goldstein BJ, Rosenstock J, Anzalone D, Tou C, Ohman KP. Effect of tesaglitazar, a dual PPAR alpha/gamma agonist, on glucose and lipid abnormalities in patients with type 2 diabetes: a 12-week dose-ranging trial. Curr Med Res Opin. 2006 Dec;22(12):2575-90.

lead_sponsor: AstraZeneca

location_country:
United States
Canada
France
Mexico

intervention_type: Behavioral


title: A Pilot, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Preliminary Clinical Activity and Immunogenicity of Multiple Doses of LEA29Y and CTLA4Ig Administered Intravenously to Subjects With Rheumatoid Arthritis

summary: This randomized, double-blind, placebo controlled, parallel and multiple dose study provided safety, preliminary efficacy, and immunogenicity information about the use of BMS-188667 and BMS-224818 in subjects with RA

location_country:
United States
Switzerland
Netherlands
Germany
France
Ireland
Belgium
Canada
United Kingdom

location_facility:
Local Instiution
Local Institution


title: A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

summary: The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.

ReferenceCitation: Sandborn WJ, Colombel JF, Frankel M, Hommes D, Lowder JN, Mayer L, Plevy S, Stokkers P, Travis S, Van Assche G, Baumgart DC, Targan SR. Anti-CD3 antibody visilizumab is not effective in patients with intravenous corticosteroid-refractory ulcerative colitis. Gut. 2010 Nov;59(11):1485-92. doi: 10.1136/gut.2009.205443.

family: Sandborn

full_name: W. J. Sandborn

given: W. J.

family: Colombel

full_name: J. F. Colombel

given: J. F.

family: Frankel

full_name: M. Frankel

given: M.

family: Hommes

full_name: D. Hommes

given: D.

family: Lowder

full_name: J. N. Lowder

given: J. N.

family: Mayer

full_name: L. Mayer

given: L.

family: Plevy

full_name: S. Plevy

given: S.

family: Stokkers

full_name: P. Stokkers

given: P.

family: Travis

full_name: S. Travis

family: Van Assche

full_name: G. Van Assche

given: G.

family: Baumgart

full_name: D. C. Baumgart

given: D. C.

family: Targan

full_name: S. R. Targan

given: S. R.

journal_name: Gut

repository_institution: Wiardi Beckman Foundation - Wiardi Beckman Foundation

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Facet Biotech

location_country:
Austria
United States
Netherlands
Germany
France
Israel
Slovakia
Norway
Hungary
Australia
Belgium
Canada
Czech Republic
Ukraine


title: A Prospective Randomised Open- Label Blinded-Endpoint (PROBE) Trial Comparing Telmisartan (MICARDIS®) (40-80-80mg QD) and Ramipril (2.5-5--10mg QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring. PRISMA = Prospective Randomised Investigation of the Safety and Efficacy of Micardis® vs Ramipril Using ABPM

acronym: PRISMA

summary: The primary objective of this study is to demonstrate that telmisartan 80 mg (MICARDIS®) is at least as effective and possibly superior to ramipril 5mg and 10mg in lowering mean ambulatory diastolic blood pressure (DBP) and systolic blood pressure (SBP) during the last 6 hours of the 24-hour dosing interval in mild-to-moderate hypertensive patients at the end of an 8 and 14-week treatment period, respectively.

location_country:
Austria
South Africa
Switzerland
Netherlands
France
Spain
Germany
United Kingdom

location_facility: Boehringer Ingelheim Investigational Site

location_facility: Rehabilitationszentrum für Herz- und Kreislauferkrankungen


title: Randomized Phase 3 Trial of Decitabine Versus Patient's Choice With Physician's Advice of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia

summary: The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.

ReferenceCitation: Mayer J, Arthur C, Delaunay J, Mazur G, Thomas XG, Wierzbowska A, Ravandi F, Berrak E, Jones M, Li Y, Kantarjian HM. Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor- or intermediate-risk cytogenetics. BMC Cancer. 2014 Feb 6;14:69. doi: 10.1186/1471-2407-14-69.

full_name: Jiří Mayer

given: Jiří

family: Arthur

full_name: Christopher Arthur

given: Christopher

family: Delaunay

full_name: Jacques Delaunay

given: Jacques

family: Mazur

full_name: Grzegorz Mazur

given: Grzegorz

family: Thomas

full_name: Xavier G Thomas

given: Xavier G

family: Wierzbowska

full_name: Agnieszka Wierzbowska

given: Agnieszka

family: Ravandi

full_name: Farhad Ravandi

given: Farhad

family: Berrak

full_name: Erhan Berrak

given: Erhan

family: Jones

full_name: Mark Jones

given: Mark

family: Li

full_name: Yuhan Li

given: Yuhan

family: Kantarjian

full_name: Hagop M Kantarjian

given: Hagop M

journal_name: BMC Cancer

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: Eisai Inc.

location_country:
United States
Serbia
Mexico
Croatia
Czechia
France
Poland
Romania
Hungary
Australia
Russian Federation
Spain
Canada
United Kingdom
Taiwan