title: Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease (COPD)

summary: The primary objective of this study is to compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20 mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20 mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of 12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed. In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of therapy will be characterized in a subgroup of patients.

ReferenceCitation: Zuwallack R, De Salvo MC, Kaelin T, Bateman ED, Park CS, Abrahams R, Fakih F, Sachs P, Pudi K, Zhao Y, Wood CC; Combivent Respimat Inhaler Study Group. Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler versus MDI. Respir Med. 2010 Aug;104(8):1179-88. doi: 10.1016/j.rmed.2010.01.017. Epub 2010 Feb 20.

family: ZuWallack

full_name: R. ZuWallack

given: R.

family: De Salvo

full_name: M.C. De Salvo

family: Kaelin

full_name: T. Kaelin

given: T.

family: Bateman

full_name: E.D. Bateman

family: Park

full_name: C.S. Park

family: Abrahams

full_name: R. Abrahams

family: Fakih

full_name: F. Fakih

given: F.

family: Sachs

full_name: P. Sachs

given: P.

family: Pudi

full_name: K. Pudi

given: K.

family: Zhao

full_name: Y. Zhao

given: Y.

family: Wood

full_name: C.C. Wood

journal_name: Respiratory Medicine

title: Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat® inhaler versus MDI

lead_sponsor: Boehringer Ingelheim

location_country:
South Africa
France
Poland
Greece
Argentina
Russian Federation
New Zealand
Turkey
United States
United Kingdom
Korea, Republic of
Taiwan
Ukraine

location_facility: 1012.56.01039 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30007 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.48002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01070 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01090 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01059 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.07007 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01093 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.44008 The Staploe Medical Centre

location_facility: 1012.56.01031 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01087 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.82006 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01028 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01034 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.88605 Taichung Veterans General Hospital

location_facility: 1012.56.54007 CLINICA PRIVADA de MONTE GRANDE

location_facility: 1012.56.01035 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.64003 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.38001 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.82007 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.38005 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54013 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54001 Centro Médico de la Dra. De Salvo

location_facility: 1012.56.48009 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01024 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01006 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.48005 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30001 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30011 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01045 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01058 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01014 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30014 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01030 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01042 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01016 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54012 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.82009 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01037 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.07010 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.27006 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01019 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01044 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01029 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01033 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.07005 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.27003 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01071 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01018 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30010 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01047 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01009 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.27008 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01026 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01079 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.90002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01064 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54015 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.27004 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.44007 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54005 Instituto de Diagnóstico Cardiovascular La Plata

location_facility: 1012.56.90006 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01051 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01049 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01004 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01055 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.82010 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01080 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.38002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01010 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01084 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01021 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.88603 National Taiwan University Hospital

location_facility: 1012.56.3305A Centre hospitalier Germon & Gauthier

location_facility: 1012.56.64001 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.44010 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.07008 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.07009 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01007 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54006 CENTRO PRIVADO de MEDICINA RESPIRATORIA

location_facility: 1012.56.01008 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.88601 Chang Gung Memorial Hosp-Linkou

location_facility: 1012.56.01068 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01013 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30013 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01015 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54009 Instituto de Investigaciones Clínicas

location_facility: 1012.56.01025 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01078 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01063 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01067 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01003 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.48004 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01040 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01089 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01072 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01069 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01088 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01054 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01023 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.48011 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.44006 Colchester General Hospital

location_facility: 1012.56.48006 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01012 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01020 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54011 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01038 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01085 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01001 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01027 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.27005 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01076 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01043 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01050 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.90001 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.90005 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01032 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.64004 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.88604 Chang Gong Memorial Hospital

location_facility: 1012.56.01077 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01017 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.44009 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.82001 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01036 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01060 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.44003 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.82008 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.27001 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01005 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01057 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.48003 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.07001 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.64005 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01066 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.64006 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01081 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.38004 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01053 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01011 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01082 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.3304A Centre Médical Erdre Saint Augustin

location_facility: 1012.56.01065 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.07002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.44002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01048 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01062 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.48007 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01056 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.07003 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.27002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01022 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01052 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01074 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.90003 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30003 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.27009 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.38006 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01083 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54014 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.30009 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.01075 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.54008 HOSPITAL ITALIANO de ROSARIO

location_facility: 1012.56.82005 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.48001 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.82002 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.48010 Boehringer Ingelheim Investigational Site

location_facility: 1012.56.88602 Taipei Veterans General Hospital

location_facility: 1012.56.01073 Boehringer Ingelheim Investigational Site


title: A 2-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety Of CP-945,598 In The Treatment Of Obese Subjects

summary: The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Pfizer

location_country:
Chile
Sweden
Mexico
Germany
France
Argentina
Australia
Spain
United States
United Kingdom
Korea, Republic of

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: Randomized, Multicenter, Double-blinded, Phase IV Study Evaluating the Efficacy (as Measured by Sustained Virological Response) and Safety of 360 μg Induction Dosing of Pegasys® in Combination With Higher Copegus® Doses in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Baseline Body Weight Greater Than or Equal to 85 kg

summary: This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po daily. Following 48 weeks treatment, there will be a 24-week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

status: Completed

ReferenceType: derived

ReferenceCitation: Reddy KR, Shiffman ML, Rodriguez-Torres M, Cheinquer H, Abdurakhmanov D, Bakulin I, Morozov V, Silva GF, Geyvandova N, Stanciu C, Rabbia M, McKenna M, Thommes JA, Harrison SA; PROGRESS Study Investigators. Induction pegylated interferon alfa-2a and high dose ribavirin do not increase SVR in heavy patients with HCV genotype 1 and high viral loads. Gastroenterology. 2010 Dec;139(6):1972-83. doi: 10.1053/j.gastro.2010.08.051. Epub 2010 Sep 30.

family: Reddy

full_name: K. Rajender Reddy

given: K. Rajender

sequence: first

family: Shiffman

full_name: Mitchell L. Shiffman

given: Mitchell L.

sequence: additional

family: Rodriguez–Torres

full_name: Maribel Rodriguez–Torres

given: Maribel

family: Cheinquer

full_name: Hugo Cheinquer

given: Hugo

family: Abdurakhmanov

full_name: Djamal Abdurakhmanov

given: Djamal

family: Bakulin

full_name: Igor Bakulin

given: Igor

family: Morozov

full_name: Viacheslav Morozov

given: Viacheslav

family: Silva

full_name: Giovanni Faria Silva

given: Giovanni Faria

family: Geyvandova

full_name: Natalia Geyvandova

given: Natalia

family: Stanciu

full_name: Carol Stanciu

given: Carol

family: Rabbia

full_name: Michael Rabbia

given: Michael

family: McKenna

full_name: Michael McKenna

family: Thommes

full_name: James A. Thommes

given: James A.

family: Harrison

full_name: Stephen A. Harrison

given: Stephen A.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Gastroenterology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Induction Pegylated Interferon Alfa-2a and High Dose Ribavirin Do Not Increase SVR in Heavy Patients With HCV Genotype 1 and High Viral Loads

lead_sponsor: Hoffmann-La Roche

location_country:
Brazil
United States
Sweden
Netherlands
Germany
France
Poland
Romania
Hungary
Belgium
Puerto Rico
Russian Federation
Denmark
Canada
United Kingdom

status_simplified: Completed


type: EudraCT Number

type: Other Identifier

title: Multicenter Study to Investigate the Bleeding Profile and the Insertion Easiness in Women Inserted With a Second Consecutive MIRENA for Contraception or Menorrhagia

summary: The purpose of this study is to assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use.

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Heikinheimo O, Inki P, Kunz M, Parmhed S, Anttila AM, Olsson SE, Hurskainen R, Gemzell-Danielsson K. Double-blind, randomized, placebo-controlled study on the effect of misoprostol on ease of consecutive insertion of the levonorgestrel-releasing intrauterine system. Contraception. 2010 Jun;81(6):481-6. doi: 10.1016/j.contraception.2010.01.020. Epub 2010 Mar 1.

family: Heikinheimo

full_name: Oskari Heikinheimo

given: Oskari

family: Inki

full_name: Pirjo Inki

given: Pirjo

family: Kunz

full_name: Michael Kunz

family: Parmhed

full_name: Sule Parmhed

given: Sule

family: Anttila

full_name: Anna-Maija Anttila

given: Anna-Maija

family: Olsson

full_name: Sven-Eric Olsson

given: Sven-Eric

family: Hurskainen

full_name: Ritva Hurskainen

given: Ritva

family: Gemzell-Danielsson

full_name: Kristina Gemzell-Danielsson

given: Kristina

journal_name: Contraception

ReferenceCitation: Gemzell-Danielsson K, Inki P, Boubli L, O'Flynn M, Kunz M, Heikinheimo O. Bleeding pattern and safety of consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS)--a multicentre prospective study. Hum Reprod. 2010 Feb;25(2):354-9. doi: 10.1093/humrep/dep426. Epub 2009 Dec 1.

full_name: K. Gemzell-Danielsson

full_name: P. Inki

family: Boubli

full_name: L. Boubli

given: L.

family: O'Flynn

full_name: M. O'Flynn

given: M.

full_name: M. Kunz

full_name: O. Heikinheimo

given: O.

journal_name: Human Reproduction

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Heikinheimo O, Inki P, Kunz M, Gemzell-Danielsson K. Predictors of bleeding and user satisfaction during consecutive use of the levonorgestrel-releasing intrauterine system. Hum Reprod. 2010 Jun;25(6):1423-7. doi: 10.1093/humrep/deq079. Epub 2010 Apr 8.

ReferenceCitation: Heikinheimo O, Inki P, Schmelter T, Gemzell-Danielsson K. Bleeding pattern and user satisfaction in second consecutive levonorgestrel-releasing intrauterine system users: results of a prospective 5-year study. Hum Reprod. 2014 Jun;29(6):1182-8. doi: 10.1093/humrep/deu063. Epub 2014 Mar 28.


title: Effects of Bosentan on Morbidity and Mortality in Patients With Idiopathic Pulmonary Fibrosis - a Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Group Sequential, Phase III Study.

acronym: BUILD 3

summary: BUILD 3 is a prospective, multicenter, randomized, double-blind, parallel group, placebo-controlled, event-driven, group sequential, phase III superiority study. The primary objective is to demonstrate that bosentan delays disease worsening or death in patients with Idiopathic Pulmonary Fibrosis.

ReferenceCitation: King TE Jr, Brown KK, Raghu G, du Bois RM, Lynch DA, Martinez F, Valeyre D, Leconte I, Morganti A, Roux S, Behr J. BUILD-3: a randomized, controlled trial of bosentan in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011 Jul 1;184(1):92-9. doi: 10.1164/rccm.201011-1874OC. Epub 2011 Apr 7.

family: King

full_name: Talmadge E. King

given: Talmadge E.

suffix: Jr.

family: Brown

full_name: Kevin K. Brown

given: Kevin K.

family: Raghu

full_name: Ganesh Raghu

given: Ganesh

family: du Bois

full_name: Roland M. du Bois

given: Roland M.

family: Lynch

full_name: David A. Lynch

given: David A.

family: Martinez

full_name: Fernando Martinez

given: Fernando

family: Valeyre

full_name: Dominique Valeyre

given: Dominique

family: Leconte

full_name: Isabelle Leconte

given: Isabelle

family: Morganti

full_name: Adele Morganti

given: Adele

family: Roux

full_name: Sébastien Roux

given: Sébastien

family: Behr

full_name: Juergen Behr

given: Juergen

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

title: BUILD-3: A Randomized, Controlled Trial of Bosentan in Idiopathic Pulmonary Fibrosis

lead_sponsor: Actelion

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

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

location_facility: Inselspital Bern-Div of Pulmonary Medicine

location_facility: Medizinische Universitätsklinik, Abteilung Pneumologie

location_facility: University of Virginia - Div. of Pulmonary & Critical Care

location_facility: University Hospital Basel-Div of Pneumology

location_facility: Institut za Plucne bolest l TBC Klinickog Centra Srbije

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

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

location_facility: University of Chicago - Section of Pulmonary, Dept of Medicine, Respiratory Clinical Research

location_facility: Toronto General Hospital-Rosedale Medical Center PFT Lab

location_facility: Hopital Notre Dame - Centre Hospitalier de L'Universit de Montreal

location_facility: Ospedale San Giuseppe Milanocuore, Unita Operativa di Pneumologia

location_facility: Royal Perth Hospital; Advanced Lung Disease Unit

location_facility: SoonChunHyang University Bucheon Hospital

location_facility: Medical University of Innsbruck-Div. of Clinical & Internal Medicine

location_facility: University Hospital for Lung Disease "Jordanovac"

location_facility: St. Luke's Medical Group, Cardio-Pulmonary Research

location_facility: Rambam Medical Centre-Div. for Pulmonary Disease

location_facility: National Jewish Medical & Research Center

location_facility: Highland Hospital - Pulmonary Department

location_facility: Royal Adelaide Hospital-Respiratory Clinical Trials Unit

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

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

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

location_facility: Klinik Löwenstein GmbH-Medizinische Klinik 1 Pneumologie-Kardiologie

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

location_facility: UCLA-Division of Pulmonary & Critical Care

location_facility: University Hospital Olomouc - Dept of Respiratory Disease-IP Pavlova

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

location_facility: University of Pennsylvania Medical Center

location_facility: Medical University of Vienna and AKH-Div of Pulmonology

location_facility: Yale University School of Medicine-Dept of Internal Med-Pulmonary & Critical Care

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

location_facility: Hospital Clinic Barcelona (Pneumology Service)

location_facility: Azienda Sanitaria di Forli-Presidio Ospedaliero Stabilimento

location_facility: Klinik Donaustauf-Zentrum für Pneumologie

location_facility: Kanagawa Cardiovascular Respiratory Center

location_facility: Hadassah Medical Organization: Ein Karem-Institute of Pulmonology

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

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

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

location_facility: Thomayer Faculty Hospital Prague-Dept of Respiratory Disease

location_facility: University degli Studi Siena, Policlinico le Scotte

location_facility: Institut za Plucne bolesti Vojvodine, Sremska Kamenica

location_facility: Fachkrankenhaus Coswig; Centre for Pulmonology and Thoracic Surgery

location_facility: Azienda Ospedaliera di Padova - Immunologia Clinica

location_facility: Pulmonary Istitute-Rabin Medical Centre: Beilinson Campus

location_facility: Medizinische Universität Graz-Klinische Abteilung für Pulmonologie


title: A Six Month, Open-Label Outpatient, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control Compared To Insulin Glargine (Lantus®) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents

summary: To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.

location_country: Sweden Switzerland Netherlands Finland France Poland Norway Belgium Spain Germany


type: U.S. NIH Grant/Contract

title: A Randomized Trial of Unruptured Brain Arteriovenous Malformations

acronym: ARUBA

summary: The purpose of this study is to determine if medical management is better than invasive therapy for improving the long-term outcome of patients with unruptured brain arteriovenous malformations.

ReferenceType: background

ReferenceCitation: Stapf C, Mohr JP, Choi JH, Hartmann A, Mast H. Invasive treatment of unruptured brain arteriovenous malformations is experimental therapy. Curr Opin Neurol. 2006 Feb;19(1):63-8. Review.

ReferenceCitation: Mohr JP, Overbey JR, Hartmann A, Kummer RV, Al-Shahi Salman R, Kim H, van der Worp HB, Parides MK, Stefani MA, Houdart E, Libman R, Pile-Spellman J, Harkness K, Cordonnier C, Moquete E, Biondi A, Klijn CJM, Stapf C, Moskowitz AJ; ARUBA co-investigators. Medical management with interventional therapy versus medical management alone for unruptured brain arteriovenous malformations (ARUBA): final follow-up of a multicentre, non-blinded, randomised controlled trial. Lancet Neurol. 2020 Jul;19(7):573-581. doi: 10.1016/S1474-4422(20)30181-2.

family: Mohr

full_name: Jay P Mohr

given: Jay P

family: Overbey

full_name: Jessica R Overbey

given: Jessica R

family: Hartmann

full_name: Andreas Hartmann

given: Andreas

family: Kummer

full_name: Rüdiger von Kummer

given: Rüdiger von

family: Al-Shahi Salman

full_name: Rustam Al-Shahi Salman

given: Rustam

family: Kim

full_name: Helen Kim

given: Helen

family: van der Worp

full_name: H Bart van der Worp

given: H Bart

family: Parides

full_name: Michael K Parides

given: Michael K

family: Stefani

full_name: Marco A Stefani

given: Marco A

family: Houdart

full_name: Emmanuel Houdart

given: Emmanuel

family: Libman

full_name: Richard Libman

given: Richard

family: Pile-Spellman

full_name: John Pile-Spellman

given: John

family: Harkness

full_name: Kirsty Harkness

given: Kirsty

family: Cordonnier

full_name: Charlotte Cordonnier

given: Charlotte

family: Moquete

full_name: Ellen Moquete

given: Ellen

family: Biondi

full_name: Alessandra Biondi

given: Alessandra

family: Klijn

full_name: Catharina J M Klijn

given: Catharina J M

family: Stapf

full_name: Christian Stapf

given: Christian

family: Moskowitz

full_name: Alan J Moskowitz

given: Alan J

journal_name: The Lancet Neurology

oa_host_type: repository

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

host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Edinburgh - Edinburgh Research Explorer

version: submittedVersion

ReferenceCitation: Mohr JP, Overbey JR, von Kummer R, Stefani MA, Libman R, Stapf C, Parides MK, Pile-Spellman J, Moquete E, Moy CS, Vicaut E, Moskowitz AJ, Harkness K, Cordonnier C, Biondi A, Houdart E, Berkefeld J, Klijn CJM, Barreau X, Kim H, Hartmann A; International ARUBA Investigators. Functional impairments for outcomes in a randomized trial of unruptured brain AVMs. Neurology. 2017 Oct 3;89(14):1499-1506. doi: 10.1212/WNL.0000000000004532. Epub 2017 Sep 6.

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Mohr JP, Parides MK, Stapf C, Moquete E, Moy CS, Overbey JR, Al-Shahi Salman R, Vicaut E, Young WL, Houdart E, Cordonnier C, Stefani MA, Hartmann A, von Kummer R, Biondi A, Berkefeld J, Klijn CJ, Harkness K, Libman R, Barreau X, Moskowitz AJ; international ARUBA investigators. Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial. Lancet. 2014 Feb 15;383(9917):614-21. doi: 10.1016/S0140-6736(13)62302-8. Epub 2013 Nov 20.

ReferenceCitation: Stapf C. The rationale behind "A Randomized Trial of Unruptured Brain AVMs" (ARUBA). Acta Neurochir Suppl. 2010;107:83-5. doi: 10.1007/978-3-211-99373-6_13.

title: The Rationale Behind “A Randomized Trial of Unruptured Brain AVMs” (ARUBA)

ReferenceCitation: Stapf C, Mohr JP. Unruptured brain arteriovenous malformations should be treated conservatively: yes. Stroke. 2007 Dec;38(12):3308-9. Epub 2007 Oct 25.

location_country:
Italy
Austria
United States
Brazil
Switzerland
Netherlands
Germany
Finland
France
Australia
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Universitätsklinik für Neurologie, Anichstrasse 35, 6020 Innsbruck

location_facility: Hospital Universitari de Bellvitge, Sección de Neuroradiologia, c/ Feixa Llarga s/n, L'Hospitalet de Llobregat

location_facility: Berufsgenossenschaftliche Kliniken Bergmannstrost, Klinik für Neurochirurgie, Merseburger Str. 165

location_facility: Uniklinikum Frankfurt, Institut für Neuroradiologie, Schleusenweg 2-16

location_facility: Michigan Head and Spine Institute, Providence Hospital and Medical Center, 16001 West Nine Mile Road

location_facility: Uniklinikum Dresden, Neuroradiologie, Fetscherstr. 74

location_facility: Walton Centre for Neurology, Lower Lane Fazakerley

location_facility: CHUM Notre Dame Hospital, Department of Radiology, 1560 Sherbrooke Street

location_facility: Universitätsklinik Heidelberg, Department of Neurosurgery, Im Neuenheimer Feld 400

location_facility: Department of Neurology, Royal Hallamshire Hospital, Glossop Road

location_facility: Rudolfstiftung, Neurochirurgie, Juchgasse 25, A-1030

location_facility: Helsinki University Central Hospital, Dept. of Neurosurgery, Topeliuksenkatu 5, Helsinki, P.O. Box 266

location_facility: Department of Neurosurgery, Universitair Medisch Centrum Groningen Hanzeplein 1

location_facility: Utrecht University Hospital, Heidelberglaan 100, 3584 CX

location_facility: Brackenridge Hospital, Brain and Spine Center, 601 East 15th Street

location_facility: Loyola University Stritch School of Medicine, Department of Neurology, 2160 S 1st Ave, Bldg 105/2700

location_facility: Mount Sinai Hospital, One Gustave L. Levy Place, Department of Neurosurgery- Box 1136

location_facility: Frenchay Hospital, Neuroradiology Department

location_facility: Centre Hospitalier Régional et Universitaire de Lille, Clinique de Neurochirurgie, Hopital Roger Salengro, CHRU

location_facility: John P. Murtha Neuroscience & Pain Institute,1450 Scapl Ave, Suite 120,

location_facility: Inselspital, Neurologische Klinik, 3010 Bern

location_facility: Universitätsklinikum Essen, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie, Hufelandstraße 55

location_facility: New York Presbyterian Hospital, Columbia Campus, Neurological Institute, 710 W. 168th St

location_facility: Hamilton General Hospital .237 Barton Street East

location_facility: University of Iowa Hospitals, Department of Neurology, 200 Hawkins Drive ,

location_facility: University of California at San Francisco, 1001 Potrero Avenue- Rm 3C-38

location_facility: SUNY Downstate Medical Center, 451 Clarkson Avenue, Box 1189

location_facility: Thomas Jefferson Hospital for Neuroscience

location_facility: Hôpital Sainte Anne, Service de Neurochirurgie, Centre Hospitalier Sainte Anne, 1, Rue Cabanis

location_facility: CHU Henri Mondor, Service de Neuroradiologie

location_facility: Bellaria Hospital, Department of Neurosurgery

location_facility: Department of Neuroradiology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52

location_facility: Western General Hospital, Bramwell Dott Building, Department of Clinical Neurosciences, Crewe Road

location_facility: Klinikum Großhadern, LMU München, Neurologische Klinik und Poliklinik, Marchionistr. 15

location_facility: University of Virginia School of Medicine, Department of Neurosurgery, P.O. Box 800212

location_facility: University of California at Los Angeles, UCLA School of Medicine, 710 Westwood Plaza

location_facility: University of Texas Medical School in Houston

location_facility: Hôpital de la Cavale-Blanche, Service de Neurologie, Bd. Tanguy Pringent

location_facility: Kaiser Permanente Los Angeles Medical Center,4867 Sunset Blvd

location_facility: Servizio di Neuroradiologia, Ospedale San Raffaele, Via Olgettina 60

location_facility: European Coordinating Center: Dept. of Neurology, Hôpital Lariboisière, 2 Rue Ambroise Paré, 75475 Paris cedex 10,

location_facility: Department of Neurosurgery, Newcastle General Hospital, Westgate Road

location_facility: Barrow Neurological Institute, 350 West Thomas Road

location_facility: Charité Campus Benjamin Franklin (CCBF), Neurologische Klinik, Hindenburgdamm 30

location_facility: Neuroscience Department, Royal Preston Hospital, Sharoe Green Lane, Fulwood

location_facility: Consultant Neurologist, Department of Neurology, Leeds General Infirmary, Great George Street

location_facility: Hôpital Lariboisière, Service de Neuroradiologie, 2, Rue Ambroise Paré

location_facility: Austin Health, University of Melbourne 300 Waterdale Rd,Heidelberg Heights

location_facility: Institute of Neurology, Box 6, The National Hospital, Queen Square

location_facility: Uniklinik Freiburg, Neuroradiology-Neurocenter, Breisacher Str. 64


title: A Prospective, Randomized, Active Controlled, Parallel Group, Multi-center Trial to Assess the Efficacy and Safety of Mycophenolate Mofetil (MMF) in Inducing Response and Maintaining Remission in Subjects With Lupus Nephritis.

summary: This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term efficacy of MMF compared to azathioprine in maintaining remission and renal function. Patients were randomized to receive either MMF (1.5 g twice daily [bid]) or cyclophosphamide (0.5-1.0 g/m^2 in monthly pulses) in the induction phase. Those patients meeting criteria for response were re-randomized for entry into the maintenance phase, to receive either MMF (1 g bid) or azathioprine (2 mg/kg/day).

ReferenceCitation: Sundel R, Solomons N, Lisk L; Aspreva Lupus Management Study (ALMS) Group. Efficacy of mycophenolate mofetil in adolescent patients with lupus nephritis: evidence from a two-phase, prospective randomized trial. Lupus. 2012 Nov;21(13):1433-43. doi: 10.1177/0961203312458466. Epub 2012 Aug 24.

name: Boston Children’s Hospital, and Department of Pediatrics, Harvard Medical School, USA

family: Sundel

full_name: R Sundel

given: R

name: Clinical Department, Vifor Pharma (formerly Aspreva Pharmaceuticals), Canada

family: Solomons

full_name: N Solomons

given: N

family: Lisk

full_name: L Lisk

given: L

journal_name: Lupus

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Dooley MA, Jayne D, Ginzler EM, Isenberg D, Olsen NJ, Wofsy D, Eitner F, Appel GB, Contreras G, Lisk L, Solomons N; ALMS Group. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. N Engl J Med. 2011 Nov 17;365(20):1886-95. doi: 10.1056/NEJMoa1014460.

family: Dooley

full_name: Mary Anne Dooley

given: Mary Anne

family: Jayne

full_name: David Jayne

given: David

family: Ginzler

full_name: Ellen M. Ginzler

given: Ellen M.

family: Isenberg

full_name: David Isenberg

family: Olsen

full_name: Nancy J. Olsen

given: Nancy J.

family: Wofsy

full_name: David Wofsy

family: Eitner

full_name: Frank Eitner

given: Frank

family: Appel

full_name: Gerald B. Appel

given: Gerald B.

family: Contreras

full_name: Gabriel Contreras

given: Gabriel

full_name: Laura Lisk

given: Laura

full_name: Neil Solomons

given: Neil

journal_name: New England Journal of Medicine

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

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Mycophenolate versus Azathioprine as Maintenance Therapy for Lupus Nephritis

ReferenceCitation: Dall'Era M, Stone D, Levesque V, Cisternas M, Wofsy D. Identification of biomarkers that predict response to treatment of lupus nephritis with mycophenolate mofetil or pulse cyclophosphamide. Arthritis Care Res (Hoboken). 2011 Mar;63(3):351-7. doi: 10.1002/acr.20397. Epub 2010 Nov 15.

family: Dall'Era

full_name: Maria Dall'Era

given: Maria

family: Stone

full_name: David Stone

family: Levesque

full_name: Victoria Levesque

given: Victoria

ReferenceCitation: Ginzler EM, Wofsy D, Isenberg D, Gordon C, Lisk L, Dooley MA; ALMS Group. Nonrenal disease activity following mycophenolate mofetil or intravenous cyclophosphamide as induction treatment for lupus nephritis: findings in a multicenter, prospective, randomized, open-label, parallel-group clinical trial. Arthritis Rheum. 2010 Jan;62(1):211-21. doi: 10.1002/art.25052. Erratum in: Arthritis Rheum. 2010 Oct;62(10):3005.

title: Nonrenal disease activity following mycophenolate mofetil or intravenous cyclophosphamide as induction treatment for lupus nephritis: Findings in a multicenter, prospective, randomized, open-label, parallel-group clinical trial

ReferenceCitation: Isenberg D, Appel GB, Contreras G, Dooley MA, Ginzler EM, Jayne D, Sánchez-Guerrero J, Wofsy D, Yu X, Solomons N. Influence of race/ethnicity on response to lupus nephritis treatment: the ALMS study. Rheumatology (Oxford). 2010 Jan;49(1):128-40. doi: 10.1093/rheumatology/kep346. Epub 2009 Nov 20.

location_country:
Italy
Brazil
United Kingdom
Mexico
Spain
Germany
France
Greece
Hungary
Belgium
Argentina
Australia
China
United States
Czech Republic
Canada
Portugal


title: A Phase II, Multicenter, Randomized, Open-label, Active Controlled Study to Evaluate the Safety and Efficacy of Micafungin Salvage Mono-therapy Versus Active Control Intravenous Salvage Mono-therapy in Patients With Invasive Aspergillosis

summary: To evaluate the efficacy and safety of micafungin in patients with proven invasive aspergillosis and who are refractory or intolerant to previous systemic antifungal therapy. To compare the efficacy and safety of the micafungin therapy with the active control arm

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
Brazil
Croatia
France
Poland
Hungary
Belgium
Argentina
Spain
Germany
Czech Republic
Colombia


title: A Phase III, International, Randomised, Double Blind, Parallel-Group Study to Assess the Efficacy of Zactima™ Versus Tarceva® in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Failure of at Least One Prior Chemotherapy

summary: To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung Cancer and if so, how it compares with another type of anti cancer therapy chemotherapy, Erlotinib

ReferenceCitation: Natale RB, Thongprasert S, Greco FA, Thomas M, Tsai CM, Sunpaweravong P, Ferry D, Mulatero C, Whorf R, Thompson J, Barlesi F, Langmuir P, Gogov S, Rowbottom JA, Goss GD. Phase III trial of vandetanib compared with erlotinib in patients with previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2011 Mar 10;29(8):1059-66. doi: 10.1200/JCO.2010.28.5981. Epub 2011 Jan 31.

name: From the Cedars-Sinai Outpatient Cancer Center, Los Angeles, CA; Sarah Cannon Research Institute, Nashville, TN; Florida Cancer Specialists, Bradenton, FL; AstraZeneca, Wilmington, DE; Maharaj Nakorn Chiangmai Hospital, Chiang Mai University, Chiang Mai; Prince of Songkla University, Songkhla, Thailand; University of Heidelberg, Heidelberg, Germany; Taipei Veterans General Hospital, Taipei, Taiwan; New Cross Hospital, Wolverhampton; St James' Institute of Oncology, Leeds; Birmingham Heartlands Hospital,...

family: Natale

full_name: Ronald B. Natale

given: Ronald B.

family: Thongprasert

full_name: Sumitra Thongprasert

given: Sumitra

family: Greco

full_name: F. Anthony Greco

given: F. Anthony

family: Thomas

full_name: Michael Thomas

given: Michael

family: Tsai

full_name: Chun-Ming Tsai

given: Chun-Ming

family: Sunpaweravong

full_name: Patrapim Sunpaweravong

given: Patrapim

family: Ferry

full_name: David Ferry

family: Mulatero

full_name: Clive Mulatero

given: Clive

family: Whorf

full_name: Robert Whorf

given: Robert

family: Thompson

full_name: Joyce Thompson

given: Joyce

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Langmuir

full_name: Peter Langmuir

given: Peter

family: Gogov

full_name: Sven Gogov

given: Sven

family: Rowbottom

full_name: Jacqui A. Rowbottom

given: Jacqui A.

family: Goss

full_name: Glenwood D. Goss

given: Glenwood D.

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Phase III Trial of Vandetanib Compared With Erlotinib in Patients With Previously Treated Advanced Non–Small-Cell Lung Cancer

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

location_country:
Australia
Denmark
Taiwan
India
France
Thailand
Norway
Argentina
Indonesia
Canada
Korea, Republic of
Hong Kong
Netherlands
Philippines
China
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Spain


title: An Open Label, Stratified, Single-arm Phase II Study of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumor (NET) After Failure of Cytotoxic Chemotherapy

summary: The purpose of this study was to assess the efficacy and safety of everolimus in the treatment of advanced pancreatic neuroendocrine tumor (NET) not responsive to cytotoxic chemotherapy. All patients were treated with everolimus until either tumor progression was documented using a standard criteria that measures tumor size called Response Evaluation Criteria in Solid tumors (RECIST), or until unacceptable toxicity occurred, or until the patient or investigator requested discontinuation of treatment.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Sweden
Netherlands
Germany
France
Belgium
Argentina
Australia
Spain
Canada

location_facility: Cedars-Sinai Outpatient Cancer Center/Samuel Oschin Comprehensive Cancer Inst.

location_facility: Arthur G. James Cancer Hospital/Ohio State University

location_facility: H. Lee Moffit Cancer Center & Research Institute

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of Wisconsin Hospital & Clinics


title: A Three Cohort Phase II Trial of BMS-275183 Given Orally on a Twice Weekly Schedule in Pretreated Locally Advanced or Metastatic NSCLC Patients

summary:
BMS-275183 given orally twice weekly to patients pretreated for locally advanced or metastatic NSCLC will show anti-tumor activity in any of the 3 separate cohorts of the patients enrolled:

Cohort I: Patients previously treated with one taxane containing regimen.
Cohort II: Patients previously treated with a platinum based but non-taxane containing regimen.
Cohort III: Patients previously treated with both a chemotherapy regimen and one EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitor) compound.

Patients in cohorts I and II should have not been treated with a prior EGFR-TKI compound. Prior treatment with a VEGFR (vascular endothelial growth factor receptor) inhibitor compound is allowed for all the patients provided that the VEGFR inhibitor is not also an EGFR inhibitor.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
Netherlands
France
Belgium
Spain
Canada
United Kingdom


title: A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase

acronym: TRANSFORMS

summary: This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.

ReferenceCitation: Cohen JA, Khatri B, Barkhof F, Comi G, Hartung HP, Montalban X, Pelletier J, Stites T, Ritter S, von Rosenstiel P, Tomic D, Kappos L; TRANSFORMS (TRial Assessing injectable interferoN vS. FTY720 Oral in RRMS) Study Group. Long-term (up to 4.5 years) treatment with fingolimod in multiple sclerosis: results from the extension of the randomised TRANSFORMS study. J Neurol Neurosurg Psychiatry. 2016 May;87(5):468-75. doi: 10.1136/jnnp-2015-310597. Epub 2015 Jun 25.

family: Cohen

full_name: Jeffrey A Cohen

given: Jeffrey A

family: Khatri

full_name: Bhupendra Khatri

given: Bhupendra

family: Barkhof

full_name: Frederik Barkhof

given: Frederik

family: Comi

full_name: Giancarlo Comi

given: Giancarlo

family: Hartung

full_name: Hans-Peter Hartung

given: Hans-Peter

family: Montalban

full_name: Xavier Montalban

given: Xavier

family: Pelletier

full_name: Jean Pelletier

given: Jean

family: Stites

full_name: Tracy Stites

given: Tracy

family: Ritter

full_name: Shannon Ritter

given: Shannon

family: von Rosenstiel

full_name: Philipp von Rosenstiel

given: Philipp

family: Tomic

full_name: Davorka Tomic

given: Davorka

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Khatri BO, Pelletier J, Kappos L, Hartung HP, Comi G, Barkhof F, von Rosenstiel P, Meng X, Grinspan A, Hashmonay R, Cohen JA; TRANSFORMS Study Group. Effect of prior treatment status and reasons for discontinuation on the efficacy and safety of fingolimod vs. interferon β-1a intramuscular: Subgroup analyses of the Trial Assessing Injectable Interferon vs. Fingolimod Oral in Relapsing-Remitting Multiple Sclerosis (TRANSFORMS). Mult Scler Relat Disord. 2014 May;3(3):355-63. doi: 10.1016/j.msard.2013.11.006. Epub 2013 Dec 12.

full_name: B.O. Khatri

full_name: J. Pelletier

given: J.

full_name: L. Kappos

given: L.

full_name: H.-P. Hartung

journal_name: Multiple Sclerosis and Related Disorders

title: Effect of prior treatment status and reasons for discontinuation on the efficacy and safety of fingolimod vs. interferon β-1a intramuscular: Subgroup analyses of the Trial Assessing Injectable Interferon vs. Fingolimod Oral in Relapsing–Remitting Multiple Sclerosis (TRANSFORMS)

ReferenceCitation: Chinea Martinez AR, Correale J, Coyle PK, Meng X, Tenenbaum N. Efficacy and safety of fingolimod in Hispanic patients with multiple sclerosis: pooled clinical trial analyses. Adv Ther. 2014 Oct;31(10):1072-81. doi: 10.1007/s12325-014-0154-4. Epub 2014 Sep 23.

title: Efficacy and Safety of Fingolimod in Hispanic Patients with Multiple Sclerosis: Pooled Clinical Trial Analyses

ReferenceCitation: Zarbin MA, Jampol LM, Jager RD, Reder AT, Francis G, Collins W, Tang D, Zhang X. Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. Ophthalmology. 2013 Jul;120(7):1432-9. doi: 10.1016/j.ophtha.2012.12.040. Epub 2013 Mar 24.

title: Ophthalmic Evaluations in Clinical Studies of Fingolimod (FTY720) in Multiple Sclerosis

ReferenceCitation: Khatri B, Barkhof F, Comi G, Hartung HP, Kappos L, Montalban X, Pelletier J, Stites T, Wu S, Holdbrook F, Zhang-Auberson L, Francis G, Cohen JA; TRANSFORMS Study Group. Comparison of fingolimod with interferon beta-1a in relapsing-remitting multiple sclerosis: a randomised extension of the TRANSFORMS study. Lancet Neurol. 2011 Jun;10(6):520-9. doi: 10.1016/S1474-4422(11)70099-0. Epub 2011 May 13.

ReferenceCitation: Twiss J, Doward LC, McKenna SP, Eckert B. Interpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS). Health Qual Life Outcomes. 2010 Oct 11;8:117. doi: 10.1186/1477-7525-8-117.

ReferenceCitation: Cohen JA, Barkhof F, Comi G, Hartung HP, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, Tiel-Wilck K, de Vera A, Jin J, Stites T, Wu S, Aradhye S, Kappos L; TRANSFORMS Study Group. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010 Feb 4;362(5):402-15. doi: 10.1056/NEJMoa0907839. Epub 2010 Jan 20.

title: Oral Fingolimod or Intramuscular Interferon for Relapsing Multiple Sclerosis

location_country:
Italy
Austria
Brazil
Switzerland
Spain
Germany
France
Korea, Republic of
Greece
Hungary
Argentina
Australia
Belgium
Egypt
United States
United Kingdom
Canada
Portugal

location_facility: Ahepa University General Hospital of Thessaloniki, 1 Stilp. Kyriakidi Str.

location_facility: Regionaal Ziekenhuis Sint-Trudo - Campus Sint-Jozef

location_facility: Unitat de Neuroimmunologia Clinica, Hospital Vall d'Hebron

location_facility: Mid America Neuroscience Institute, 8550 Marshall Drive, Suite 100

location_facility: Ciutat Sanitaria I, Universitaria De Bellvitge, c/o Feixa Llarga, Hospitalet de Llobregat

location_facility: Box Hill Hopsital, Level 3, 16 Arnold Street

location_facility: Integra Clinical Research, 4242 Medical Drive, Suite 6100

location_facility: The Walton Centre for Neurology and Neurosurgery

location_facility: Raleigh Neurology Associates, 1540 Sunday Drive

location_facility: University of Pittsburgh, Department of Neurology

location_facility: Ospedali Riuniti Umberto I - GM Lancisi - G.Salesi

location_facility: The Ottawa General Hospital, 501 Smyth Rd.

location_facility: Absher Neurology, 274-A Commonwealth Drive

location_facility: Nepean Medical Centre, 1 Centrepointe Drive, Suite 407

location_facility: University of Florida Health Science Center

location_facility: Osp. Clinicizzato Colle dell'Ara - Università G. D'Annunzio

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: Metropolitan Hospital, Ethnarchou Makariou 6 & Eleftheriou Venizelou 1

location_facility: Centre Hospitalier Universitaire de Sherbrooke, 3001 12th Avenue North

location_facility: Associated Neurologists, PC, 69 Sand Pit Road, Suite 300

location_facility: Hopital La Timone Cpcet, Rue Jean Moulin

location_facility: Mountain Empire Neurological Associates, PC, 3183 West State Street, Suite 1201

location_facility: Universitätsspital Basel, Neurochirugishen Poliklinik

location_facility: Montreal Neurological Institute, 3801 University Street

location_facility: Istituto di Scienze Neurologiche Università di Catania

location_facility: Landesklinikum St. Poelten, Probst-Ruehrer-Str. 4

location_facility: Landes-Nervenklinik Christian Doppler Klinik

location_facility: Private Clinic, 7 Batal Ahmed Abdelaziz St Abdeen

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Az. Osp. Universitaria Policlinico Tor Vergata

location_facility: University Physician Group, #1 Barnes-Jewish Hospital Plaza, Suite 16304

location_facility: Azienda Ospedaliera Careggi - Università degli Studi

location_facility: Liverpool Hospital, Neurology Department, Health Services Building, 4th Floor, Goulburn and Campbell Street

location_facility: Yonsei Univ. Med. Center,Severance Hospital, 134 Shinchon-dong, Suedaemoon-ku

location_facility: Fraser Health MS Clinic, Burnaby Hospital, 3935 Kincaid Street

location_facility: Azienda Ospedaliera di Padova - Università degli Studi

location_facility: Debreceni Egyetem Orvos es Egszstd. Centr.

location_facility: Universitätsklinik f. Neurologie Innsbruck

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: Al Azhar University, 11 Talaat Harb St, Fourth Floor, Apt 18

location_facility: University of Miami, Department of Neurology

location_facility: University of South Florida, Department of Neurology

location_facility: Azienda Ospedaliera Sant'Andrea - Università La Sapienza

location_facility: Az. Osp. Ospedale S. Martino - Università degli Studi

location_facility: Pecsi Tudomanyegyetem Neurologiai Klinika

location_facility: Nationaal Multiple Sclerose Centrum v.z.w

location_facility: General University Hospital of Patra-RIO

location_facility: Neurology & Neuroscience Associates, Inc

location_facility: General Hospital of Athens G. Gennimatas, 154 Mesogeion Ave.

location_facility: National Cancer Center, 809 Madu 1-dong, Ilsan-gu

location_facility: The Neurology Center, 3907 Waring Road, Suite 3

location_facility: Policlinico - Università degli Studi Federico II

location_facility: Hopital Central, 29 Avenue du Marechal de Lattre de Tassigny

location_facility: Centre Hospitalier de Poissy, 10 rue du Champ Gaillard

location_facility: West Virginia University Health Associates

location_facility: Axiom Clinical Research of Florida, 2919 Swann Avenue, Suite 401

location_facility: Hoppital Pasteur, Archet II, 30 avenue de la Voie

location_facility: Neurology Associates, PA, 301 N. Maitland Avenue, Suite A1

location_facility: North Central Neurology Associates, PC, 1809 Kress Street

location_facility: Az. Osp. Ospedale Consorziale e Policlinico

location_facility: Yale University Multiple Sclerosis Center

location_facility: Errikos Dinan General Hospital, 107 Mesogion Ave.

location_facility: Osp. Magg. Pol. Mangiagalli e Regina Elena - Fond. IRCCS

location_facility: Center for Neurological Disorders - Aurora St. Luke's Med Center

location_facility: Associated Neurologists of Southern CT, PC, 75 Kings Highway Cutoff

location_facility: St. Michael's Hospital, Chief, Division of Neurology, 30 Bond Street,Suite 3007 - Shuter Wing


title: A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment With Ropinirole Immediate Release Tablets (REQUIP IR) or Ropinirole Prolonged Release Tablets (SK&F-101468) in Advanced Stage Parkinson's Disease Subjects Who Are Not Adequately Controlled on L-dopa.

summary: This study was designed to compare the effectiveness and tolerability of a new prolonged release formulation of ropinirole with the currently marketed immediate release formulation which is prescribed in many countries. The new prolonged release formulation allows the drug to be taken once a day rather than three times a day. This study will also evaluate the side effects of the new prolonged release formulation of ropinirole

study_start_date_type: Actual

lead_sponsor: GlaxoSmithKline

location_country:
Italy
South Africa
France
Czechia
Bulgaria
Poland
Romania
Hungary
Russian Federation
Spain
Germany
United Kingdom
Canada
Ukraine


title: A Randomized, Open-label Study Comparing the Effects of Olanzapine Pamoate Depot With Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia

summary: To compare the health outcome of patients with schizophrenia, who are at risk for relapse, when treated with a long acting injection form of olanzapine versus treatment with oral olanzapine.

ReferenceCitation: Atkins S, Detke HC, McDonnell DP, Case MG, Wang S. A pooled analysis of injection site-related adverse events in patients with schizophrenia treated with olanzapine long-acting injection. BMC Psychiatry. 2014 Jan 14;14:7. doi: 10.1186/1471-244X-14-7.

family: Atkins

full_name: Susan Atkins

given: Susan

family: Detke

full_name: Holland C Detke

given: Holland C

family: McDonnell

full_name: David P McDonnell

given: David P

family: Case

full_name: Michael G Case

given: Michael G

family: Wang

full_name: Shufang Wang

given: Shufang

currency_apc_doaj: GBP

journal_name: BMC Psychiatry

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Peuskens J, Porsdal V, Pecenak J, Handest P, D'yachkova Y, Brousil R, Deberdt W. Schizophrenia symptoms and functioning in patients receiving long-term treatment with olanzapine long-acting injection formulation: a pooled analysis. BMC Psychiatry. 2012 Aug 31;12:130. doi: 10.1186/1471-244X-12-130.

family: Peuskens

full_name: Joseph Peuskens

given: Joseph

family: Porsdal

full_name: Vibeke Porsdal

given: Vibeke

family: Pecenak

full_name: Jan Pecenak

given: Jan

family: Handest

full_name: Peter Handest

given: Peter

family: D'yachkova

full_name: Yulia D'yachkova

given: Yulia

family: Brousil

full_name: Radim Brousil

given: Radim

family: Deberdt

full_name: Walter Deberdt

given: Walter

ReferenceCitation: McDonnell DP, Detke HC, Bergstrom RF, Kothare P, Johnson J, Stickelmeyer M, Sanchez-Felix MV, Sorsaburu S, Mitchell MI. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II: investigations of mechanism. BMC Psychiatry. 2010 Jun 10;10:45. doi: 10.1186/1471-244X-10-45.

ReferenceCitation: Detke HC, McDonnell DP, Brunner E, Zhao F, Sorsaburu S, Stefaniak VJ, Corya SA. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, I: analysis of cases. BMC Psychiatry. 2010 Jun 10;10:43. doi: 10.1186/1471-244X-10-43.

location_country:
Brazil
United States
Spain
France
Greece
Slovakia
Romania
Argentina
Puerto Rico
Portugal
Canada
Taiwan

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


publications_result: Clofarabine + Ara-c improves response rates and event-free survival, not overall survival, in older patients with relapsed/refractory AML compared to Ara-c alone: Updated CLASSIC I study results. H.M. Kantarjian, M. Wetzler, D. Rizzieri, G. J. Schiller, M. H. Jagasia, R. K. Stuart, S. Ganguly, D. Avigan, M. Craig, R. Collins, M. B. Maris, T. Kovacsovics, S. Goldberg, K. Seiter, P. Hari, J. Greiner, N. Vey, C. Recher, F. Ravandi, E.S. Wang, S. Eckert, D. Huebner and S. Faderl. Haematologica - 16th Congress of EHA Abstracts. 2011; 96(S2): 196.

ReferenceCitation: Faderl S, Wetzler M, Rizzieri D, Schiller G, Jagasia M, Stuart R, Ganguly S, Avigan D, Craig M, Collins R, Maris M, Kovacsovics T, Goldberg S, Seiter K, Hari P, Greiner J, Vey N, Recher C, Ravandi F, Wang ES, Vasconcelles M, Huebner D, Kantarjian HM. Clofarabine plus cytarabine compared with cytarabine alone in older patients with relapsed or refractory acute myelogenous leukemia: results from the CLASSIC I Trial. J Clin Oncol. 2012 Jul 10;30(20):2492-9. doi: 10.1200/JCO.2011.37.9743. Epub 2012 May 14.

name: Stefan Faderl, Farhad Ravandi, and Hagop M. Kantarjian, The University of Texas MD Anderson Cancer Center, Houston; Robert Collins, UT Southwestern Medical Center at Dallas, Dallas, TX; Meir Wetzler and Eunice S. Wang, Roswell Park Cancer Institute, Buffalo; Karen Seiter, New York Medical College, Valhalla, NY; David Rizzieri, Duke University Medical Center, Durham, NC; Gary Schiller, University of California, Los Angeles, CA; Madan Jagasia, Vanderbilt University Medical Center, Nashville, TN; Robert...

family: Faderl

full_name: Stefan Faderl

given: Stefan

family: Wetzler

full_name: Meir Wetzler

given: Meir

family: Rizzieri

full_name: David Rizzieri

given: David

family: Schiller

full_name: Gary Schiller

given: Gary

family: Jagasia

full_name: Madan Jagasia

given: Madan

family: Stuart

full_name: Robert Stuart

given: Robert

family: Ganguly

full_name: Siddhartha Ganguly

given: Siddhartha

family: Avigan

full_name: David Avigan

family: Craig

full_name: Michael Craig

given: Michael

family: Collins

full_name: Robert Collins

family: Maris

full_name: Michael Maris

family: Kovacsovics

full_name: Tibor Kovacsovics

given: Tibor

family: Goldberg

full_name: Stuart Goldberg

given: Stuart

family: Seiter

full_name: Karen Seiter

given: Karen

family: Hari

full_name: Parameswaran Hari

given: Parameswaran

family: Greiner

full_name: Jochen Greiner

given: Jochen

family: Vey

full_name: Norbert Vey

given: Norbert

family: Recher

full_name: Christian Recher

given: Christian

family: Ravandi

full_name: Farhad Ravandi

given: Farhad

full_name: Eunice S. Wang

given: Eunice S.

family: Vasconcelles

full_name: Michael Vasconcelles

family: Huebner

full_name: Dirk Huebner

given: Dirk

family: Kantarjian

full_name: Hagop M. Kantarjian

given: Hagop M.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Clofarabine Plus Cytarabine Compared With Cytarabine Alone in Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia: Results From the CLASSIC I Trial

ReferenceCitation: Ganguly S, Kantarjian HM, Wetzler M, Rizzieri D, Schiller G, Jagasia M, et al. Subsequent hematopoietic stem cell transplantation (HSCT) associated with longer survival in patients with relapsed/refractory (R/R) acute myelogenous leukemia (AML) after Clo+Ara-C or Ara-C alone: a landmark analysis from the CLASSIC I trial. Biol Blood Marrow Transplant 2012;18(2Suppl):S211-S212.

ReferenceCitation: Ganguly S, Kantarjian HM, Wetzler M, Rizzieri D, Schiller G, Jagasia M, et al. Subsequent HSCT in the CLASSIC I Study Associated with Longer Survival in Patients With Relapsed/Refractory AML After Clo+Ara-C Or Ara-C Alone: A Landmark Analysis. Haematologica - 17th Congress of EHA Abstracts. 2012; 97(s1):32

location_country:
Italy
United States
France
Germany
Canada

location_facility: University of Colorado Health Science Center

location_facility: The Cancer Center at Hackensack University Medical Center

location_facility: Wake Forest University School of Medicine

location_facility: University of Texas Health Sciences Center

location_facility: Louisiana State University Health Science Center

location_facility: Azienda Ospedaliera "Antonio Cardarelli"

location_facility: University of Kentucky, Markey Cancer Center

location_facility: Medizinische Hochschule Hannover, Zentrum fur Innere Medizin, Abt. Haematologie / Onkologie

location_facility: University of Arkansas for Medical Sciences, Arkansas Cancer Research Center

location_facility: University of Utah - Huntsman Cancer Institute

location_facility: West Virginia University Hospitals, Mary Babb Randolph Cancer Center

location_facility: Medizinische Klinik der Technischen, Universität München

location_facility: UT Southwestern Medical Center, Simmons Comprehensive Cancer Center

location_facility: University of Oklahoma Health Sciences Center

location_facility: University of Southern California, Kenneth Norris Cancer Center

title: A Phase III Randomized, Double-blind, Controlled Study Comparing Clofarabine and Cytarabine Versus Cytarabine Alone in Adult Patients 55 Years and Older With Acute Myelogenous Leukemia (AML) Who Have Relapsed or Are Refractory After Receiving up to Two Prior Induction Regimens

summary:
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute or refractory lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.

There is no recommended standard treatment for relapsed or refractory acute myelogenous leukemia in older patients. Cytarabine is the most commonly used drug to treat these patients. This study will determine if there is benefit by combining clofarabine with cytarabine. Patients will be randomized to receive up to 3 cycles of treatment with either placebo in combination with cytarabine or clofarabine in combination with cytarabine. Randomization was stratified by remission status following the first induction regimen (no remission [i.e., CR1 = refractory] or remission <6 months vs CR1 = remission ≥6 months). CR1 is defined as remission after first pre-study induction regimen. The safety and tolerability of clofarabine in combination with cytarabine and cytarabine alone will be monitored throughout the study.


title: An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects

summary: GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safety and tolerability of FPV containing regimens for those subjects who received FPV in previous GlaxoSmithKline studies.

lead_sponsor: ViiV Healthcare

location_country:
Italy
Brazil
Chile
Spain
France
Portugal
United States
United Kingdom


title: Phase III Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Chemotherapy With Fludarabine and Cyclophosphamide (FC) Alone in Patients With Previously Untreated Chronic Lymphocytic Leukaemia

summary: This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared to fludarabine and cyclophosphamide in treating patients with B-cell chronic lymphocytic leukemia.

ReferenceCitation: Bloehdorn J, Krzykalla J, Holzmann K, Gerhardinger A, Jebaraj BMC, Bahlo J, Humphrey K, Tausch E, Robrecht S, Mertens D, Schneider C, Fischer K, Hallek M, Döhner H, Benner A, Stilgenbauer S. Integrative prognostic models predict long-term survival after immunochemotherapy in chronic lymphocytic leukemia patients. Haematologica. 2021 Mar 18. doi: 10.3324/haematol.2020.251561. [Epub ahead of print]

family: Bloehdorn

full_name: Johannes Bloehdorn

given: Johannes

family: Krzykalla

full_name: Julia Krzykalla

given: Julia

family: Holzmann

full_name: Karlheinz Holzmann

given: Karlheinz

family: Gerhardinger

full_name: Andreas Gerhardinger

given: Andreas

family: Jebaraj

full_name: Billy Michael Chelliah Jebaraj

given: Billy Michael Chelliah

family: Bahlo

full_name: Jasmin Bahlo

given: Jasmin

family: Humphrey

full_name: Kathryn Humphrey

given: Kathryn

family: Tausch

full_name: Eugen Tausch

given: Eugen

family: Robrecht

full_name: Sandra Robrecht

given: Sandra

family: Mertens

full_name: Daniel Mertens

given: Daniel

family: Schneider

full_name: Christof Schneider

given: Christof

family: Fischer

full_name: Kirsten Fischer

given: Kirsten

family: Hallek

full_name: Michael Hallek

family: Döhner

full_name: Hartmut Döhner

given: Hartmut

family: Benner

full_name: Axel Benner

given: Axel

family: Stilgenbauer

full_name: Stephan Stilgenbauer

given: Stephan

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

publisher: Ferrata Storti Foundation (Haematologica)

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

publisher_group: Ferrata Storti Foundation (Haematologica)

publisher_normalized: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Jaramillo S, Agathangelidis A, Schneider C, Bahlo J, Robrecht S, Tausch E, Bloehdorn J, Hoechstetter M, Fischer K, Eichhorst B, Goede V, Hallek M, Döhner H, Rosenquist R, Ghia P, Stamatopoulos K, Stilgenbauer S. Prognostic impact of prevalent chronic lymphocytic leukemia stereotyped subsets: analysis within prospective clinical trials of the German CLL Study Group (GCLLSG). Haematologica. 2020 Nov 1;105(11):2598-2607. doi: 10.3324/haematol.2019.231027.

family: Sonia Jaramillo

full_name: Sonia Jaramillo

family: Andreas Agathangelidis

full_name: Andreas Agathangelidis

family: Christof Schneider

family: Jasmin Bahlo

family: Sandra Robrecht

family: Eugen Tausch

ReferenceCitation: Kreuzberger N, Damen JA, Trivella M, Estcourt LJ, Aldin A, Umlauff L, Vazquez-Montes MD, Wolff R, Moons KG, Monsef I, Foroutan F, Kreuzer KA, Skoetz N. Prognostic models for newly-diagnosed chronic lymphocytic leukaemia in adults: a systematic review and meta-analysis. Cochrane Database Syst Rev. 2020 Jul 31;7:CD012022. doi: 10.1002/14651858.CD012022.pub2.

name: Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

name: Cochrane Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University; Utrecht Netherlands

name: Centre for Statistics in Medicine; University of Oxford; Oxford UK

name: Haematology/Transfusion Medicine; NHS Blood and Transplant; Oxford UK

name: Nuffield Department of Primary Care Health Sciences; University of Oxford; Oxford UK

name: Kleijnen Systematic Reviews Ltd; York UK

name: Julius Center for Health Sciences and Primary Care; University Medical Center Utrecht, Utrecht University; Utrecht Netherlands

name: Department of Health Research Methods, Evidence, and Impact; McMaster University; Hamilton Canada

name: Center of Integrated Oncology Cologne-Bonn, Department I of Internal Medicine; University of Cologne, Faculty of Medicine and University Hospital Cologne; Cologne Germany

name: Cochrane Cancer, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

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

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

ReferenceCitation: Dimier N, Delmar P, Ward C, Morariu-Zamfir R, Fingerle-Rowson G, Bahlo J, Fischer K, Eichhorst B, Goede V, van Dongen JJM, Ritgen M, Böttcher S, Langerak AW, Kneba M, Hallek M. A model for predicting effect of treatment on progression-free survival using MRD as a surrogate end point in CLL. Blood. 2018 Mar 1;131(9):955-962. doi: 10.1182/blood-2017-06-792333. Epub 2017 Dec 18.

name: Roche Products Ltd, Welwyn, United Kingdom;

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

name: Department I of Internal Medicine, Center of Integrated Oncology Cologne-Bonn, University Hospital Cologne, Cologne, Germany;

name: Department of Immunology, Laboratory for Medical Immunology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands;

name: Department of Immunohematology and Blood Transfusion, Leiden University Medical Center, Leiden, The Netherlands;

name: Second Department of Medicine, University of Schleswig-Holstein, Kiel, Germany; and

name: Department of Hematology, Oncology and Palliative Medicine, Center for Internal Medicine, University of Rostock, Rostock, Germany

ReferenceCitation: Fischer K, Bahlo J, Fink AM, Goede V, Herling CD, Cramer P, Langerbeins P, von Tresckow J, Engelke A, Maurer C, Kovacs G, Herling M, Tausch E, Kreuzer KA, Eichhorst B, Böttcher S, Seymour JF, Ghia P, Marlton P, Kneba M, Wendtner CM, Döhner H, Stilgenbauer S, Hallek M. Long-term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: updated results of the CLL8 trial. Blood. 2016 Jan 14;127(2):208-15. doi: 10.1182/blood-2015-06-651125. Epub 2015 Oct 20.

name: Department I for Internal Medicine and Center of Integrated Oncology, University of Cologne, Cologne, Germany;

name: Department of Internal Medicine III, University of Ulm, Ulm, Germany;

name: Department of Internal Medicine II, University Hospital of Schleswig-Holstein, Kiel, Germany;

name: Peter MacCallum Cancer Centre and University of Melbourne, Melbourne, Australia;

name: Division of Experimental Oncology and Department of Onco-Hematology, Università Vita-Salute San Raffaele and Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Scientifico San Raffaele, Milano, Italy;

name: Princess Alexandra Hospital, Brisbane, Australia;

name: University of Queensland, Brisbane, Australia;

name: Department of Hematology, Oncology, Immunology, Palliative Care, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany; and

name: Cluster of Excellence Cellular Stress Responses in Aging Associated Diseases, University of Cologne, Cologne, Germany

ReferenceCitation: Weisser M, Yeh RF, Duchateau-Nguyen G, Palermo G, Nguyen TQ, Shi X, Stinson SY, Yu N, Dufour A, Robak T, Salogub GN, Dmoszynska A, Solal-Celigny P, Warzocha K, Loscertales J, Catalano J, Larratt L, Rossiev VA, Bence-Bruckler I, Geisler CH, Montillo M, Fischer K, Fink AM, Hallek M, Bloehdorn J, Busch R, Benner A, Döhner H, Valente N, Wenger MK, Stilgenbauer S, Dornan D. PTK2 expression and immunochemotherapy outcome in chronic lymphocytic leukemia. Blood. 2014 Jul 17;124(3):420-5. doi: 10.1182/blood-2013-12-538975. Epub 2014 Jun 10.

name: Roche Pharma Research and Early Development, Penzberg, Germany;

name: Biostatistics, Genentech Inc., South San Francisco, CA;

name: F. Hoffman–La Roche Ltd., Basel, Switzerland;

name: Molecular Diagnostics and Cancer Cell Biology, Genentech Inc., South San Francisco, CA;

name: Laboratory for Leukemia Diagnostics, Ludwig Maximilians University, Munich, Germany;

name: Department of Haematology, Medical University, Lodz, Poland;

name: Hematology Department, Saint Petersburg Pavlov State Medical University, Saint Petersburg, Russia;

name: Haematooncology and Bone Marrow Transplantation Department, Medical University, Lublin, Poland;

name: Department of Hematology, Institut de Cancérologie de l'Ouest, Nantes, France;

name: Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland;

name: Department of Hematology, Hospital Universitario de La Princesa, IIS-IP, Madrid, Spain;

name: Dorevitch Pathology Laboratory, Frankston Hospital, Frankston, Australia;

name: Division of Clinical Hematology, Walter C. Mackenzie Health Sciences Centre, Edmonton, AB, Canada;

name: Haematology Department, Samara Region Clinical Hospital, Samara, Russia;

name: Department of Medicine, University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, ON, Canada;

name: Department of Hematology, Rigshospitalet, Copenhagen, Denmark;

name: Department of Haematology & Oncology, Division of Haematology, Ospedale Niguarda Ca' Granda, Milan, Italy;

name: Department I of Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany;

name: Institute for Medical Statistics and Epidemiology, Technical University of Munich, Munich, Germany;

name: Division of Biostatistics, German Cancer Research Center, Heidelberg, Germany;

name: BioOncology, Genentech Inc., South San Francisco, CA; and

name: Pharmaceuticals Division, F. Hoffmann–La Roche Ltd., Basel, Switzerland

title: PTK2 expression and immunochemotherapy outcome in chronic lymphocytic leukemia

ReferenceCitation: Pflug N, Bahlo J, Shanafelt TD, Eichhorst BF, Bergmann MA, Elter T, Bauer K, Malchau G, Rabe KG, Stilgenbauer S, Döhner H, Jäger U, Eckart MJ, Hopfinger G, Busch R, Fink AM, Wendtner CM, Fischer K, Kay NE, Hallek M. Development of a comprehensive prognostic index for patients with chronic lymphocytic leukemia. Blood. 2014 Jul 3;124(1):49-62. doi: 10.1182/blood-2014-02-556399. Epub 2014 May 5.

name: Department I of Internal Medicine and Center of Integrated Oncology Cologne Bonn, University of Cologne, Cologne, Germany;

name: Department of Internal Medicine, Division of Hematology, Mayo Clinic, Rochester, MN;

name: Department I of Internal Medicine, Hospital München-Schwabing, Munich, Germany;

name: Cochrane Hematological Malignancies Group, University of Cologne, Cologne, Germany;

name: Institute of Clinical Chemistry, University Hospital of Cologne, Cologne, Germany;

name: Department of Health Sciences Research, Mayo Clinic, Rochester, MN;

name: Department of Internal Medicine III, Ulm University, Ulm, Germany;

name: Department of Internal Medicine I, Division of Hematology and Haemostaseology and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria;

name: Hämatologische und Onkologische Schwerpunktpraxis, Erlangen, Germany;

name: Department III of Internal Medicine, University Hospital of Salzburg, Salzburg, Austria; and

name: Institute for Medical Statistics and Epidemiology, Technical University Munich, Munich, Germany

ReferenceCitation: Stilgenbauer S, Schnaiter A, Paschka P, Zenz T, Rossi M, Döhner K, Bühler A, Böttcher S, Ritgen M, Kneba M, Winkler D, Tausch E, Hoth P, Edelmann J, Mertens D, Bullinger L, Bergmann M, Kless S, Mack S, Jäger U, Patten N, Wu L, Wenger MK, Fingerle-Rowson G, Lichter P, Cazzola M, Wendtner CM, Fink AM, Fischer K, Busch R, Hallek M, Döhner H. Gene mutations and treatment outcome in chronic lymphocytic leukemia: results from the CLL8 trial. Blood. 2014 May 22;123(21):3247-54. doi: 10.1182/blood-2014-01-546150. Epub 2014 Mar 20.

name: Department of Translational Oncology, National Center for Tumor Diseases and German Cancer Research Center, and Department of Medicine V, University of Heidelberg, Heidelberg, Germany;

name: Department of Hematology Oncology, Fondazione Istituto Di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, University of Pavia, Italy;

name: Second Department of Medicine, University Hospital of Schleswig-Holstein, Campus Kiel, Kiel, Germany;

name: Cooperation Unit “Mechanisms of Leukemogenesis,” German Cancer Research Center, Heidelberg, Germany;

name: Department of Hematology, Medical University of Vienna, Vienna, Austria;

name: Roche Molecular Systems, Pleasanton, CA;

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

name: Department of Internal Medicine I, University Hospital Cologne, Cologne, Germany;

name: Division of Molecular Genetics, German Cancer Research Center, Heidelberg, Germany;

name: Department I of Internal Medicine, Klinikum Schwabing, Munich, Germany; and

ReferenceCitation: Eichhorst BF, Fischer K, Fink AM, Elter T, Wendtner CM, Goede V, Bergmann M, Stilgenbauer S, Hopfinger G, Ritgen M, Bahlo J, Busch R, Hallek M; German CLL Study Group (GCLLSG). Limited clinical relevance of imaging techniques in the follow-up of patients with advanced chronic lymphocytic leukemia: results of a meta-analysis. Blood. 2011 Feb 10;117(6):1817-21. doi: 10.1182/blood-2010-04-282228. Epub 2010 Dec 7.

name: Department I of Internal Medicine, Centre of Integrated Oncology Köln Bonn, University of Cologne, Cologne, Germany;

name: Cluster of Excellence on Cellular Stress Responses in Aging-associated Diseases (CECAD Cologne), Cologne, Germany;

name: Department III for Internal Medicine, University of Ulm, Ulm, Germany;

name: IIIrd Medical Department, Paracelsus Medical University Salzburg, Salzburg, Austria;

name: Department II for Internal Medicine, University Schleswig-Holstein, Campus Kiel, Germany; and

name: Institute of Medical Statistics and Epidemiology, Technical University, Munich, Germany

ReferenceCitation: Hallek M, Fischer K, Fingerle-Rowson G, Fink AM, Busch R, Mayer J, Hensel M, Hopfinger G, Hess G, von Grünhagen U, Bergmann M, Catalano J, Zinzani PL, Caligaris-Cappio F, Seymour JF, Berrebi A, Jäger U, Cazin B, Trneny M, Westermann A, Wendtner CM, Eichhorst BF, Staib P, Bühler A, Winkler D, Zenz T, Böttcher S, Ritgen M, Mendila M, Kneba M, Döhner H, Stilgenbauer S; International Group of Investigators; German Chronic Lymphocytic Leukaemia Study Group. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010 Oct 2;376(9747):1164-74. doi: 10.1016/S0140-6736(10)61381-5.

location_country:
Italy
Austria
France
Israel
Australia
Belgium
New Zealand
Spain
Denmark
Germany
Czech Republic

location_facility: Medizinische Universitaetsklinik I at the University of Cologne

location_facility: Privatklinik Dr. R. Schindlbeck GmbH & Co. KG

location_facility: Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie

location_facility: Schwerpunktpraxis Hamatologie/Onkologie - Wesel

location_facility: Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

location_facility: St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

location_facility: Praxis fuer Haematologie und Interne Onkologie

location_facility: Internistische Gemeinschaftspraxis - Forchheim

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: University Hospital Schleswig-Holstein - Kiel Campus

location_facility: Krankenanstalt Mutterhaus der Borromaerinnen

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Onkologische Schwerpunktpraxis at Facharzt fuer Innere Medizin

location_facility: Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

location_facility: Krankenhaus Barmherzige Brueder Regensburg

location_facility: Praxis Fuer Internistische Haematologie / Onkologie

location_facility: Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg

location_facility: Klinik fuer Onkologie - Katharinenhospital Stuttgart

location_facility: Hamatologisch - Onkologische Praxis Wurzburg

location_facility: Fondazione Centro San Raffaele Del Monte Tabor

location_facility: Copenhagen County Herlev University Hospital

location_facility: Internistische Gemeinschaftspraxis - Berlin

location_facility: Riverview Cancer Care Medical Associates, PC

location_facility: Westmead Institute for Cancer Research at Westmead Hospital

location_facility: University Medical Center Hamburg - Eppendorf

location_facility: Internistische Gemeinschaftspraxis - Offenbach

location_facility: Marienhospital at Ruhr University Bochum

location_facility: Internistische Gemeinschaftspraxis - Oldenburg

location_facility: Onkologische Schwerpunktpraxis Dr. Schmidt

location_facility: Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

location_facility: Praxis Fur Hamatologie und Onkologie Ahaus

location_facility: Praxis Fuer Haematologie Internistische Onkologie

location_facility: Staedtisches Klinikum Magdeburg - Altstadt

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH

location_facility: Haematologisch - Onkologische Gemeinschaftspraxis

location_facility: Clinic for Bone Marrow Transplantation and Hematology and Oncology

location_facility: Staedtisches Krankenhaus Muenchen - Harlaching

location_facility: Internistische Onkologische Praxis - Kronach

location_facility: Internistische Gemeinschaftspraxis - Kassel

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

location_facility: Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

location_facility: Staedtische Kliniken Frankfurt am Main - Hoechst

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen

location_facility: St. Marien-Hospital Hamm - Klinik Knappenstrasse

location_facility: Internistische Gemeinschaftspraxis - Magdeburg

location_facility: Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg

location_facility: University Hospital in Pilsen - Lochotin

location_facility: Onkologische Gemeinschaftspraxis - Dresden

location_facility: Onkologische Gemeinschaftspraxis - Trier

location_facility: Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik

location_facility: Klinikum der Universitaet Muenchen - Grosshadern Campus

location_facility: Krankenhaus Siloah - Medizinische Klinik II

location_facility: Hamatologie/Onkologie Praxisgemeinschaft - Muenchen

location_facility: Internistische Gemeinschaftspraxis - Stuttgart

location_facility: Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

location_facility: First Medical Clinic of Charles University Hospital


title: A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension 0.25mg/kg and 0.125 mg/kg Administered Once Daily in Comparison to Naproxen Oral Suspension 5mg/kg Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis.

summary: A one year double-blind trial to investigate the efficacy and safety of meloxicam oral suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis.

location_country:
Italy
Austria
France
Belgium
Russian Federation
Germany
United Kingdom

location_facility: Univ.-Klinik für Kinder- und Jugendheilkunde Wien

location_facility: Scientific Research Institute of Pediatric Hematology

location_facility: Gottfried Preyersches Kinderspital d. Stadt Wien

location_facility: Boehringer Ingelheim Investigational Site

location_facility: Medical Faculty of Russian People Friendship University


title: An Open-label, Non-Comparative Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Faslodex (Fulvestrant) in Girls With Progressive Precocious Puberty Associated With McCune-Albright Syndrome

acronym: FMAS

summary: The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty (early puberty) in girls with McCune-Albright syndrome (MAS).

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Sims EK, Garnett S, Guzman F, Paris F, Sultan C, Eugster EA; Fulvestrant McCune-Albright study group. Fulvestrant treatment of precocious puberty in girls with McCune-Albright syndrome. Int J Pediatr Endocrinol. 2012 Sep 22;2012(1):26. doi: 10.1186/1687-9856-2012-26.

family: Sims

full_name: Emily K Sims

given: Emily K

family: Garnett

full_name: Sally Garnett

given: Sally

family: Guzman

full_name: Franco Guzman

given: Franco

family: Paris

full_name: Françoise Paris

given: Françoise

family: Sultan

full_name: Charles Sultan

given: Charles

family: Eugster

full_name: Erica A Eugster

given: Erica A

journal_name: International Journal of Pediatric Endocrinology

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

lead_sponsor: AstraZeneca

location_country:
Italy
United States
France
Russian Federation
Spain
Germany
United Kingdom

status_simplified: Ongoing


title: Double-blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-experienced Subjects

summary: A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple antiretroviral experienced patients and the dose that achieves the best efficacy and safety as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and laboratory profile measures would be selected for further clinical study.

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

location_facility: Wake Forest University Baptist Medical Center

location_facility: Rush-Presbytarian-St Luke's Medical Center

location_facility: Hospital Clínico y Provincial de Barcelona - HIV

location_facility: Fondazione Centro S. Raffaele del Monte Tabor

location_facility: Community Research Initiative of New England

location_facility: Montreal Chest Institute - McGill University Health Centre

location_facility: 4th Floor Research Office (St Stephens Centre)


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain

summary: Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.

ReferenceCitation: Irving G, Pénzes J, Ramjattan B, Cousins M, Rauck R, Spierings EL, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, Mortensen ER. A randomized, placebo-controlled phase 3 trial (Study SB-767905/013) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain. J Pain. 2011 Feb;12(2):175-84. doi: 10.1016/j.jpain.2010.06.013.

family: Irving

full_name: Gordon Irving

given: Gordon

family: Pénzes

full_name: Janos Pénzes

given: Janos

family: Ramjattan

full_name: Brian Ramjattan

given: Brian

family: Cousins

full_name: Michael Cousins

given: Michael

family: Rauck

full_name: Richard Rauck

given: Richard

family: Spierings

full_name: Egilius L.H. Spierings

given: Egilius L.H.

family: Kleoudis

full_name: Christi S. Kleoudis

given: Christi S.

family: Snidow

full_name: Jerry W. Snidow

given: Jerry W.

family: Pierce

full_name: Amy Pierce

given: Amy

family: Wurzelmann

full_name: John Wurzelmann

given: John

family: Mortensen

full_name: Eric R. Mortensen

given: Eric R.

journal_name: The Journal of Pain

title: A Randomized, Placebo-Controlled Phase 3 Trial (Study SB-767905/013) of Alvimopan for Opioid-Induced Bowel Dysfunction in Patients With Non-Cancer Pain

lead_sponsor: Cubist Pharmaceuticals LLC

location_country:
United States
South Africa
Sweden
Switzerland
Netherlands
France
Norway
Hungary
Australia
New Zealand
Spain
Canada


title: Phase III Randomized, Controlled, Open-label Trial to Investigate the Antiviral Activity, Tolerability and Safety of TMC114/r in Treatment- Naive HIV-1 Infected Patients.

summary: The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r versus Kaletra (a combination pill of lopinavir and ritonavir, ("lpv/rtv") in HIV-1 infected patients who have never been treated with anti-retroviral medications (referred to as "treatment-naïve" patients).

ReferenceCitation: Mills AM, Nelson M, Jayaweera D, Ruxrungtham K, Cassetti I, Girard PM, Workman C, Dierynck I, Sekar V, Abeele CV, Lavreys L. Once-daily darunavir/ritonavir vs. lopinavir/ritonavir in treatment-naive, HIV-1-infected patients: 96-week analysis. AIDS. 2009 Aug 24;23(13):1679-88. doi: 10.1097/QAD.0b013e32832d7350.

family: Mills

full_name: Anthony M Mills

given: Anthony M

family: Nelson

full_name: Mark Nelson

given: Mark

family: Jayaweera

full_name: Dushyantha Jayaweera

given: Dushyantha

family: Ruxrungtham

full_name: Kiat Ruxrungtham

given: Kiat

family: Cassetti

full_name: Isabel Cassetti

given: Isabel

family: Girard

full_name: Pierre-Marie Girard

given: Pierre-Marie

family: Workman

full_name: Cassy Workman

given: Cassy

family: Dierynck

full_name: Inge Dierynck

given: Inge

family: Sekar

full_name: Vanitha Sekar

given: Vanitha

family: Abeele

full_name: Carline Vanden Abeele

given: Carline Vanden

family: Lavreys

full_name: Ludo Lavreys

given: Ludo

journal_name: AIDS

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Orkin C, DeJesus E, Khanlou H, Stoehr A, Supparatpinyo K, Lathouwers E, Lefebvre E, Opsomer M, Van de Casteele T, Tomaka F. Final 192-week efficacy and safety of once-daily darunavir/ritonavir compared with lopinavir/ritonavir in HIV-1-infected treatment-naïve patients in the ARTEMIS trial. HIV Med. 2013 Jan;14(1):49-59. doi: 10.1111/j.1468-1293.2012.01060.x. Epub 2012 Oct 23.

name: Barts and The London NHS Trust; London; UK

family: Orkin

full_name: C Orkin

given: C

name: Orlando Immunology Center; Orlando; FL; USA

family: DeJesus

full_name: E DeJesus

given: E

name: AIDS Healthcare Foundation; Los Angeles; CA; USA

family: Khanlou

full_name: H Khanlou

given: H

name: Institute for Interdisciplinary Medicine; Hamburg; Germany

family: Stoehr

full_name: A Stoehr

given: A

name: Chiang Mai University; Chiang Mai; Thailand

family: Supparatpinyo

full_name: K Supparatpinyo

given: K

family: Lathouwers

full_name: E Lathouwers

family: Lefebvre

full_name: E Lefebvre

family: Opsomer

full_name: M Opsomer

given: M

family: Van de Casteele

full_name: T Van de Casteele

given: T

family: Tomaka

full_name: F Tomaka

given: F

location_country:
Guatemala
Malaysia
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
Costa Rica
France
Panama
Thailand
Argentina
Canada
South Africa
Chile
Switzerland
Singapore
Puerto Rico
Germany
United States
United Kingdom
Austria
Mexico
Spain


title: A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO)

summary: The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

lead_sponsor: Warner Chilcott

location_country:
Brazil
Lebanon
Finland
France
Poland
Norway
Hungary
Belgium
Argentina
Australia
Spain
Estonia
United States
Canada