title: An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670)in β-thalassemia Patients With Transfusional Iron Overload

summary:
A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to receive chelation therapy with deferasirox for an additional 4 years.

The objective of this study is to assess the efficacy and long-term safety of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older.

ReferenceCitation: Cappellini MD, Bejaoui M, Agaoglu L, Canatan D, Capra M, Cohen A, Drelichman G, Economou M, Fattoum S, Kattamis A, Kilinc Y, Perrotta S, Piga A, Porter JB, Griffel L, Dong V, Clark J, Aydinok Y. Iron chelation with deferasirox in adult and pediatric patients with thalassemia major: efficacy and safety during 5 years' follow-up. Blood. 2011 Jul 28;118(4):884-93. doi: 10.1182/blood-2010-11-316646. Epub 2011 May 31. Erratum in: Blood. 2011 Nov 3;118(18):5060.

name: Universitá di Milano, Ca Granda Foundation Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy;

family: Cappellini

full_name: M. Domenica Cappellini

given: M. Domenica

name: Centre National de Greffe de Moelle Osseuse, Bab Saadoun, Tunis, Tunisia;

family: Bejaoui

full_name: Mohamed Bejaoui

given: Mohamed

name: Istanbul University Medical Faculty, Istanbul, Turkey;

family: Agaoglu

full_name: Leyla Agaoglu

given: Leyla

name: Suleyman Demirel University Medical Faculty, Isparta, Turkey;

family: Canatan

full_name: Duran Canatan

given: Duran

name: Ospedale Civico, G Di Cristina e Benfratelli, Palermo, Italy;

family: Capra

full_name: Marcello Capra

given: Marcello

name: Children's Hospital of Philadelphia, Philadelphia, PA;

family: Cohen

full_name: Alan Cohen

given: Alan

name: Hospital de Ninos Ricardo Gutierrez, Buenos Aires, Argentina;

family: Drelichman

full_name: Guillermo Drelichman

given: Guillermo

name: Hippokration General Hospital of Thessaloniki, Thessaloniki, Greece;

family: Economou

full_name: Marina Economou

given: Marina

family: Fattoum

full_name: Slaheddine Fattoum

given: Slaheddine

name: First Department of Pediatrics, University of Athens, Athens, Greece;

family: Kattamis

full_name: Antonis Kattamis

given: Antonis

name: Cukurova University Medical Faculty, Adana, Turkey;

family: Kilinc

full_name: Yurdanur Kilinc

given: Yurdanur

name: I Policlinico II Universitá di Napoli, Naples, Italy;

family: Perrotta

full_name: Silverio Perrotta

given: Silverio

family: Piga

full_name: Antonio Piga

given: Antonio

name: University College London, London, United Kingdom;

family: Porter

full_name: John B. Porter

given: John B.

name: Novartis Pharmaceuticals, East Hanover, NJ;

family: Griffel

full_name: Louis Griffel

given: Louis

family: Dong

full_name: Victor Dong

given: Victor

name: Novartis Pharma AG, Basel, Switzerland; and

family: Clark

full_name: Joan Clark

given: Joan

name: Ege University Medical Faculty, Izmir, Turkey

family: Aydinok

full_name: Yesim Aydinok

given: Yesim

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

location_country:
Italy
United States
Brazil
Germany
France
Greece
Tunisia
Belgium
Argentina
Turkey
Canada
United Kingdom

location_facility: Children's Hospital Boston, Dept of Hematology

location_facility: Children's Hospital and Research Center at Oakland


type: EudraCT Number

title: A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery. RE-NOVATE (Extended Thromboembolism Prevention After Hip Surgery)

summary: The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Feuring M, Kreuzer J, Huo M, Friedman RJ. Oral dabigatran etexilate versus enoxaparin for venous thromboembolism prevention after total hip arthroplasty: pooled analysis of two phase 3 randomized trials. Thromb J. 2015 Nov 17;13:36. doi: 10.1186/s12959-015-0067-8. eCollection 2015.

family: Eriksson

full_name: Bengt I. Eriksson

given: Bengt I.

sequence: first

family: Dahl

full_name: Ola E. Dahl

given: Ola E.

sequence: additional

family: Rosencher

full_name: Nadia Rosencher

given: Nadia

family: Clemens

full_name: Andreas Clemens

given: Andreas

family: Hantel

full_name: Stefan Hantel

given: Stefan

family: Feuring

full_name: Martin Feuring

given: Martin

family: Kreuzer

full_name: Jörg Kreuzer

given: Jörg

family: Huo

full_name: Michael Huo

given: Michael

family: Friedman

full_name: Richard J. Friedman

given: Richard J.

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Thrombosis Journal

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Kurth AA. Efficacy of delayed thromboprophylaxis with dabigatran: pooled analysis. Thromb Res. 2012 Dec;130(6):871-6. doi: 10.1016/j.thromres.2012.08.315. Epub 2012 Sep 17.

family: Kurth

full_name: Andreas A. Kurth

given: Andreas A.

title: Efficacy of delayed thromboprophylaxis with dabigatran: Pooled analysis

ReferenceCitation: Rosencher N, Noack H, Feuring M, Clemens A, Friedman RJ, Eriksson BI. Type of anaesthesia and the safety and efficacy of thromboprophylaxis with enoxaparin or dabigatran etexilate in major orthopaedic surgery: pooled analysis of three randomized controlled trials. Thromb J. 2012 Jun 18;10(1):9. doi: 10.1186/1477-9560-10-9.

ReferenceCitation: Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, Büller HR; RE-NOVATE Study Group. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007 Sep 15;370(9591):949-56. Erratum in: Lancet. 2007 Dec 15;370(9604):2004.

location_country:
Italy
Austria
South Africa
Sweden
Netherlands
Finland
France
Poland
Norway
Hungary
Australia
Belgium
Spain
Denmark
Germany
Czech Republic

location_facility: 1160.48.02703 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03602 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03402 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04806 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04573 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04606 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04807 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04605 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03107 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42005 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04601 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.35801 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.02701 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03406 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42002 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03410 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04570 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03604 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04302 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04707 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04817 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04702 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04607 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04603 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04574 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04912 Orthopädische Klinik Markgröningen gGmbH

location_facility: 1160.48.04604 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03411 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42007 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03904 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42006 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03308 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42001 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04304 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03404 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03302 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04915 Orthopädische Klinik Lindenlohe

location_facility: 1160.48.35802 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03104 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04610 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03606 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03101 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04701 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04703 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04820 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03102 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04303 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04571 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03408 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42009 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03409 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.35805 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42010 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03607 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04907 Johannes Gutenberg-Universität Mainz

location_facility: 1160.48.04706 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04803 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.35804 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04802 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04808 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04814 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03407 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04801 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04602 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04810 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42003 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03103 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04804 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03605 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03903 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03202 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04575 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03401 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04609 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42004 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03403 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04301 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04608 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03303 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03601 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04812 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03603 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03901 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.06111 Haemophillia & Thrombosis Service

location_facility: 1160.48.02704 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.35803 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42008 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03105 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03304 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03902 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.02702 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03405 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04704 Boehringer Ingelheim Investigational Site


title: A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.

summary: The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.

study_completion_date_type: Actual

design_allocation: Non-Randomized

primary_purpose: Treatment

ReferenceCitation: Lebbé C, Weber JS, Maio M, Neyns B, Harmankaya K, Hamid O, O'Day SJ, Konto C, Cykowski L, McHenry MB, Wolchok JD. Survival follow-up and ipilimumab retreatment of patients with advanced melanoma who received ipilimumab in prior phase II studies. Ann Oncol. 2014 Nov;25(11):2277-2284. doi: 10.1093/annonc/mdu441. Epub 2014 Sep 10.

family: Lebbé

full_name: C. Lebbé

given: C.

family: Weber

full_name: J.S. Weber

family: Maio

full_name: M. Maio

given: M.

family: Neyns

full_name: B. Neyns

given: B.

family: Harmankaya

full_name: K. Harmankaya

given: K.

family: Hamid

full_name: O. Hamid

given: O.

family: O'Day

full_name: S.J. O'Day

family: Konto

full_name: C. Konto

family: Cykowski

full_name: L. Cykowski

given: L.

family: McHenry

full_name: M.B. McHenry

family: Wolchok

full_name: J.D. Wolchok

journal_name: Annals of Oncology

oa_colors: green hybrid

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
Brazil
South Africa
Germany
France
Poland
Israel
Norway
Argentina
Belgium
Russian Federation
Spain
Denmark
United States
Czech Republic
Canada
Ukraine

location_facility: Center For Oncology Research & Treatment, P.A.

location_facility: Joe Arrington Cancer Research And Treatment Center

location_facility: The Christ Hospital Cancer Center Research

location_facility: Washington University School Of Medicine

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: The Prolongation of the EPAAC™ Trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children). A Multi-country, Double Blind, Placebo (PLC) Controlled, Follow-up Trial With 3 Parallel Groups (LCTZ-LCTZ, LCTZ-PLC and PLC-PLC) : Evaluation of the Long Term Efficacy and Safety of Levocetirizine (LCTZ) (5 mg/ml Oral Drops -0.125 mg/kg b.w. b.i.d.) Administered for an Additional 18 Months Period in Preventing the Onset of Asthma in Children Coming From the EPAAC Trial.

summary:
Prolongation of the EPAAC™ trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children).

36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in young atopic children.

status: Terminated

lead_sponsor: UCB Pharma

location_country:
Italy
South Africa
United Kingdom
France
Poland
Belgium
Australia
Spain
Germany
Czech Republic

intervention_type: Other

status_simplified: Unknown


title: Clinical Protocol For a Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Celecoxib (SC-58635) In The Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

acronym: PRESAP

summary: This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.

ReferenceCitation: Arber N, Lieberman D, Wang TC, Zhang R, Sands GH, Bertagnolli MM, Hawk ET, Eagle C, Coindreau J, Zauber A, Lanas A, Levin B. The APC and PreSAP trials: a post hoc noninferiority analysis using a comprehensive new measure for gastrointestinal tract injury in 2 randomized, double-blind studies comparing celecoxib and placebo. Clin Ther. 2012 Mar;34(3):569-79. doi: 10.1016/j.clinthera.2012.02.001. Epub 2012 Mar 2.

family: Arber

full_name: Nadir Arber

given: Nadir

family: Lieberman

full_name: David Lieberman

given: David

family: Wang

full_name: Timothy C. Wang

given: Timothy C.

family: Zhang

full_name: Richard Zhang

given: Richard

family: Sands

full_name: George H. Sands

given: George H.

family: Bertagnolli

full_name: Monica M. Bertagnolli

given: Monica M.

family: Hawk

full_name: Ernest T. Hawk

given: Ernest T.

family: Eagle

full_name: Craig Eagle

given: Craig

family: Coindreau

full_name: Javier Coindreau

given: Javier

family: Zauber

full_name: Ann Zauber

given: Ann

family: Lanas

full_name: Angel Lanas

given: Angel

family: Levin

full_name: Bernard Levin

given: Bernard

journal_name: Clinical Therapeutics

title: The APC and PreSAP Trials: A Post Hoc Noninferiority Analysis Using a Comprehensive New Measure for Gastrointestinal Tract Injury in 2 Randomized, Double-Blind Studies Comparing Celecoxib and Placebo

ReferenceCitation: Arber N, Spicak J, Rácz I, Zavoral M, Breazna A, Gerletti P, Lechuga MJ, Collins N, Rosenstein RB, Eagle CJ, Levin B. Five-year analysis of the prevention of colorectal sporadic adenomatous polyps trial. Am J Gastroenterol. 2011 Jun;106(6):1135-46. doi: 10.1038/ajg.2011.116. Epub 2011 Apr 19.

family: Spicak

full_name: Julius Spicak

given: Julius

family: Rácz

full_name: István Rácz

given: István

family: Zavoral

full_name: Miroslav Zavoral

given: Miroslav

family: Breazna

full_name: Aurora Breazna

given: Aurora

family: Gerletti

full_name: Paola Gerletti

given: Paola

family: Lechuga

full_name: Maria J Lechuga

given: Maria J

family: Collins

full_name: Neal Collins

given: Neal

family: Rosenstein

full_name: Rebecca B Rosenstein

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Five-Year Analysis of the Prevention of Colorectal Sporadic Adenomatous Polyps Trial

ReferenceCitation: Solomon SD, Wittes J, Finn PV, Fowler R, Viner J, Bertagnolli MM, Arber N, Levin B, Meinert CL, Martin B, Pater JL, Goss PE, Lance P, Obara S, Chew EY, Kim J, Arndt G, Hawk E; Cross Trial Safety Assessment Group. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation. 2008 Apr 22;117(16):2104-13. doi: 10.1161/CIRCULATIONAHA.108.764530. Epub 2008 Mar 31.

name: From the Cardiovascular Division (S.D.S., P.V.F.) and Department of Surgery (M.B.), Brigham and Women’s Hospital, Boston, Mass; Statistics Collaborative, Inc (J.W., R.F., G.A.), Washington, DC; National Cancer Institute (J.V., E.H.), Bethesda, Md; Division of Cancer Prevention and Population Sciences (B.L.), UT MD Anderson Cancer Center, Houston, Tex; Division of Epidemiology and Clinical Research (E.C.), National Eye Institute, Bethesda, Md; Johns Hopkins Medical Institutes (C.M., B.M.), Baltimore,...

title: Cardiovascular Risk of Celecoxib in 6 Randomized Placebo-Controlled Trials

ReferenceCitation: Arber N, Eagle CJ, Spicak J, Rácz I, Dite P, Hajer J, Zavoral M, Lechuga MJ, Gerletti P, Tang J, Rosenstein RB, Macdonald K, Bhadra P, Fowler R, Wittes J, Zauber AG, Solomon SD, Levin B; PreSAP Trial Investigators. Celecoxib for the prevention of colorectal adenomatous polyps. N Engl J Med. 2006 Aug 31;355(9):885-95.

ReferenceCitation: Solomon SD, Pfeffer MA, McMurray JJ, Fowler R, Finn P, Levin B, Eagle C, Hawk E, Lechuga M, Zauber AG, Bertagnolli MM, Arber N, Wittes J; APC and PreSAP Trial Investigators. Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas. Circulation. 2006 Sep 5;114(10):1028-35.

location_country:
Peru
Finland
Belgium
Australia
Russian Federation
Denmark
Czech Republic
Taiwan
Uruguay
France
Poland
Slovakia
Norway
Canada
South Africa
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
Ireland
China
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Israel
Spain


title: Double-Blind Parallel-Group Randomized Study Of Efficacy And Safety Of "Continuous Use" Of Celecoxib Vs. The "Usual Use" Of Celecoxib In The Treatment Of Subjects With Chronic Osteoarthritis Of The Hip Or Knee Who Require an Anti-inflammatory Medication for Control Of Their Pain

summary: To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.

ReferenceCitation: Strand V, Simon LS, Dougados M, Sands GH, Bhadra P, Breazna A, Immitt J. Treatment of osteoarthritis with continuous versus intermittent celecoxib. J Rheumatol. 2011 Dec;38(12):2625-34. doi: 10.3899/jrheum.110636. Epub 2011 Nov 1.

family: STRAND

full_name: VIBEKE STRAND

given: VIBEKE

family: SIMON

full_name: LEE S. SIMON

given: LEE S.

family: DOUGADOS

full_name: MAXIME DOUGADOS

given: MAXIME

family: SANDS

full_name: GEORGE H. SANDS

given: GEORGE H.

family: BHADRA

full_name: PRITHA BHADRA

given: PRITHA

family: BREAZNA

full_name: AURORA BREAZNA

given: AURORA

family: IMMITT

full_name: JEFF IMMITT

given: JEFF

journal_name: The Journal of Rheumatology

publisher: The Journal of Rheumatology

publisher_dissemination: The Journal of Rheumatology

publisher_group: The Journal of Rheumatology

publisher_normalized: The Journal of Rheumatology

title: Treatment of Osteoarthritis with Continuous Versus Intermittent Celecoxib

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Brazil
United States
Chile
France
Belgium
Canada
United Kingdom
Colombia


title: A Double-Blind, Placebo-Controlled, Multicenter Phase IIb Extension Study to Evaluate the Safety and Efficacy of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

summary:
Study SB-767905/008 was a multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in participants with cancer pain.

Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. The purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed Study SB-767905/008 and elected to participate in this extension study.

lead_sponsor: Cubist Pharmaceuticals LLC

location_country:
Peru
Hong Kong
Spain
Pakistan
Finland
France
Poland
Russian Federation
New Zealand
Portugal
United States
United Kingdom
Canada


title: Open Label, Dose Escalation, Followed by Open Label,Single Arm Clinical Trial of HuMax-CD4 in Patients With Mycosis Fungoides Type CTCL (Stage IB-IVB) or Sezary Syndrome Who Are Refractory or Intolerant to Targretin® (Bexarotene) and One Other Standard Therapy

summary: The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.

lead_sponsor: Emergent Product Development Seattle LLC

location_country:
Italy
United States
France
Spain
Germany

location_facility: Instituto Dermopatico dell'Immacolata IRCCS via Monti di Creta

location_facility: Instituto di Ematologia e Oncologia Medica "L. & A. Seragnoli"

location_facility: Consultation Dermatologie Niveau moins 1 Hopital Archet 2

location_facility: Hopital Saint-Louis Service de Dermatologie

location_facility: University of Milan-Fondazione IRCCS di Natura Pubblica Ospedale Maggiore Policlinico Mangiagalli e Regina Elena di Milano via Francesco Sforza

location_facility: University of kiel, Klinik Fur Dermotologie, Christian-Albrechts-Universitat Zu

location_facility: University of Essen - Universitatsklinikum Essen z. Hd. Frau Desire Zieling

location_facility: Skin Cancer Center Charite Mitte Dermatologie Fran Ramona Kursawa

location_facility: University of Turin SCDU Dermosifilopatia 2 A.S.O. Molinette S.Giovanni Battista

location_facility: University of Pennsylvania Health System

location_facility: Day Hospital Oncologico-Presidio Ospedaliero Firenze Centro Ospedale Santa Maria Nuova Azienda Sanitaria di Firenze, University of Florence

location_facility: Centre Hospitalier Lyon Sud Bat. 1F 1er etage service Hematologie

location_facility: University of Wurzburg - Universitatsklinikum Wurzburg dermato-onkologische studien

location_facility: Maternidad Planta Baja, Hospital 12 de Octubre


title: A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate

summary: This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.

ReferenceCitation: Jansen DTSL, Emery P, Smolen JS, Westhovens R, Le Bars M, Connolly SE, Ye J, Toes REM, Huizinga TWJ. Conversion to seronegative status after abatacept treatment in patients with early and poor prognostic rheumatoid arthritis is associated with better radiographic outcomes and sustained remission: post hoc analysis of the AGREE study. RMD Open. 2018 Mar 30;4(1):e000564. doi: 10.1136/rmdopen-2017-000564. eCollection 2018.

family: Jansen

full_name: Diahann T S L Jansen

given: Diahann T S L

family: Emery

full_name: Paul Emery

given: Paul

family: Smolen

full_name: Josef S Smolen

given: Josef S

family: Westhovens

full_name: Rene Westhovens

given: Rene

family: Le Bars

full_name: Manuela Le Bars

given: Manuela

family: Connolly

full_name: Sean E Connolly

given: Sean E

family: Ye

full_name: June Ye

given: June

family: Toes

full_name: René E M Toes

given: René E M

family: Huizinga

full_name: Tom W J Huizinga

given: Tom W J

journal_name: RMD Open

license: cc-by-nc

license_normalized: cc-by-nc

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

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Smolen JS, Wollenhaupt J, Gomez-Reino JJ, Grassi W, Gaillez C, Poncet C, Le Bars M, Westhovens R. Attainment and characteristics of clinical remission according to the new ACR-EULAR criteria in abatacept-treated patients with early rheumatoid arthritis: new analyses from the Abatacept study to Gauge Remission and joint damage progression in methotrexate (MTX)-naive patients with Early Erosive rheumatoid arthritis (AGREE). Arthritis Res Ther. 2015 Jun 11;17:157. doi: 10.1186/s13075-015-0671-9.

full_name: Josef S. Smolen

given: Josef S.

family: Wollenhaupt

full_name: Jürgen Wollenhaupt

given: Jürgen

family: Gomez-Reino

full_name: Juan J. Gomez-Reino

given: Juan J.

family: Grassi

full_name: Walter Grassi

given: Walter

family: Gaillez

full_name: Corine Gaillez

given: Corine

family: Poncet

full_name: Coralie Poncet

given: Coralie

ReferenceCitation: Bathon J, Robles M, Ximenes AC, Nayiager S, Wollenhaupt J, Durez P, Gomez-Reino J, Grassi W, Haraoui B, Shergy W, Park SH, Genant H, Peterfy C, Becker JC, Covucci A, Moniz Reed D, Helfrick R, Westhovens R. Sustained disease remission and inhibition of radiographic progression in methotrexate-naive patients with rheumatoid arthritis and poor prognostic factors treated with abatacept: 2-year outcomes. Ann Rheum Dis. 2011 Nov;70(11):1949-56. doi: 10.1136/ard.2010.145268. Epub 2011 Aug 6.

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

location_facility: Arthritis Assoc And Osteo Ctr Of Col Sprgs

location_facility: Rheumatology Associates Of North Alabama

location_facility: Arthritis Clinic Of Northern Virginia, P.C.


title: A Phase III, 18 Month, Multicenter, Randomized, Double-Blind, Active-Controlled Clinical Trial to Compare Rosiglitazone Versus Glipizide on the Progression of Atherosclerosis in Subjects With Type 2 Diabetes Mellitus and Cardiovascular Disease (APPROACH)

summary: The purpose of this study is to test the safety and effectiveness of rosiglitazone against a sulfonylurea in reducing or slowing the development of atherosclerosis in the blood vessels of the heart.

ReferenceType: background

ReferenceCitation: García-García HM, Garg S, Brugaletta S, Morocutti G, Ratner RE, Kolatkar NS, Kravitz BG, Miller DM, Huang C, Nesto RW, Serruys PW; APPROACH study group. Evaluation of in-stent restenosis in the APPROACH trial (Assessment on the Prevention of Progression by Rosiglitazone On Atherosclerosis in diabetes patients with Cardiovascular History). Int J Cardiovasc Imaging. 2012 Mar;28(3):455-65. doi: 10.1007/s10554-011-9836-z. Epub 2011 Feb 27.

ReferenceCitation: Gerstein HC, Ratner RE, Cannon CP, Serruys PW, García-García HM, van Es GA, Kolatkar NS, Kravitz BG, Miller DM, Huang C, Fitzgerald PJ, Nesto RW; APPROACH Study Group. Effect of rosiglitazone on progression of coronary atherosclerosis in patients with type 2 diabetes mellitus and coronary artery disease: the assessment on the prevention of progression by rosiglitazone on atherosclerosis in diabetes patients with cardiovascular history trial. Circulation. 2010 Mar 16;121(10):1176-87. doi: 10.1161/CIRCULATIONAHA.109.881003. Epub 2010 Mar 1.

ReferenceCitation: Nesto RW. Effect of rosiglitazone versus glipizide on progression of coronary atherosclerosis in patients with type 2 diabetes and coronary artery disease. American Heart Association Scientific Sessions. November 12, 2008, New Orleans, LA. (http://directnews.americanheart.org/extras/pdfs/approach_slides.pdf)

ReferenceCitation: Ratner RE, Cannon CP, Gerstein HC, Nesto RW, Serruys PW, Van Es GA, Kolatkar NS, Kravitz BG, Zalewski A, Fitzgerald PJ; APPROACH Study Group. Assessment on the Prevention of Progression by Rosiglitazone on Atherosclerosis in diabetes patients with Cardiovascular History (APPROACH): study design and baseline characteristics. Am Heart J. 2008 Dec;156(6):1074-9. doi: 10.1016/j.ahj.2008.07.025. Epub 2008 Oct 11.

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Brazil
United States
Sweden
India
Hong Kong
Mexico
Netherlands
Germany
France
Poland
Greece
Thailand
Latvia
Argentina
Russian Federation
Spain
Canada
Czech Republic
Korea, Republic of


type: Other Identifier

title: A Phase IIb Randomized, Partially Blinded, Dose-Finding Trial of TMC278 in Antiretroviral-Naive HIV-1 Infected Subjects

summary: The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.

ReferenceCitation: Pozniak AL, Morales-Ramirez J, Katabira E, Steyn D, Lupo SH, Santoscoy M, Grinsztejn B, Ruxrungtham K, Rimsky LT, Vanveggel S, Boven K; TMC278-C204 Study Group. Efficacy and safety of TMC278 in antiretroviral-naive HIV-1 patients: week 96 results of a phase IIb randomized trial. AIDS. 2010 Jan 2;24(1):55-65. doi: 10.1097/QAD.0b013e32833032ed.

family: Pozniak

full_name: Anton L Pozniak

given: Anton L

family: Morales-Ramirez

full_name: Javier Morales-Ramirez

given: Javier

family: Katabira

full_name: Elly Katabira

given: Elly

family: Steyn

full_name: Dewald Steyn

given: Dewald

family: Lupo

full_name: Sergio H Lupo

given: Sergio H

family: Santoscoy

full_name: Mario Santoscoy

given: Mario

family: Grinsztejn

full_name: Beatriz Grinsztejn

given: Beatriz

family: Ruxrungtham

full_name: Kiat Ruxrungtham

given: Kiat

family: Rimsky

full_name: Laurence T Rimsky

given: Laurence T

family: Vanveggel

full_name: Simon Vanveggel

given: Simon

family: Boven

full_name: Katia Boven

given: Katia

journal_name: AIDS

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Austria
Brazil
South Africa
Mexico
Germany
France
Thailand
Uganda
Argentina
Puerto Rico
Russian Federation
China
United States
United Kingdom


title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis

summary: This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

ReferenceCitation: Drobinski PJ, Bay-Jensen AC, Karsdal MA, Sardar S, Siebuhr AS. Connective tissue remodelling is differently modulated by tocilizumab versus methotrexate monotherapy in patients with early rheumatoid arthritis: the AMBITION study. Arthritis Res Ther. 2021 Jan 7;23(1):13. doi: 10.1186/s13075-020-02378-7.

family: Drobinski

full_name: Patryk J. Drobinski

given: Patryk J.

family: Bay-Jensen

full_name: Anne C. Bay-Jensen

given: Anne C.

family: Karsdal

full_name: Morten A. Karsdal

given: Morten A.

family: Sardar

full_name: Samra Sardar

given: Samra

family: Siebuhr

full_name: Anne S. Siebuhr

given: Anne S.

journal_name: Arthritis Research & Therapy

evidence: oa repository (via page says license)

repository_normalized: Research Square

version: submittedVersion

repository_institution: Research Square - Research Square

repositories:
PubMed Central
Research Square

ReferenceCitation: Jones G, Wallace T, McIntosh MJ, Brockwell L, Gómez-Reino JJ, Sebba A. Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study. J Rheumatol. 2017 Feb;44(2):142-146. doi: 10.3899/jrheum.160287. Epub 2016 Dec 1.

family: Jones

full_name: Graeme Jones

given: Graeme

family: Wallace

full_name: Thomas Wallace

given: Thomas

family: McIntosh

full_name: Matthew J. McIntosh

given: Matthew J.

family: Brockwell

full_name: Laura Brockwell

given: Laura

family: Gómez-Reino

full_name: Juan J. Gómez-Reino

family: Sebba

full_name: Anthony Sebba

given: Anthony

oa_host_type: publisher

evidence: open (via free pdf)

ReferenceCitation: Wang J, Bansal AT, Martin M, Germer S, Benayed R, Essioux L, Lee JS, Begovich A, Hemmings A, Kenwright A, Taylor KE, Upmanyu R, Cutler P, Harari O, Marchini J, Criswell LA, Platt A. Genome-wide association analysis implicates the involvement of eight loci with response to tocilizumab for the treatment of rheumatoid arthritis. Pharmacogenomics J. 2013 Jun;13(3):235-41. doi: 10.1038/tpj.2012.8. Epub 2012 Apr 10.

ReferenceCitation: Jones G, Sebba A, Gu J, Lowenstein MB, Calvo A, Gomez-Reino JJ, Siri DA, Tomsic M, Alecock E, Woodworth T, Genovese MC. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis. 2010 Jan;69(1):88-96. doi: 10.1136/ard.2008.105197.

location_country:
Italy
United States
Peru
South Africa
Serbia
Mexico
Spain
France
Lithuania
Israel
Norway
Argentina
Australia
China
Denmark
Canada
Slovenia
Portugal


title: A PhaseIIb, 96 Week, Randomised, Partially Double-blinded, Multicentre, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK and Antiviral Effect of GW873140 in Combination With COMBIVIR (Lamivudine and Zidovudine) Upon Selected Immunological and Virological Markers of HIV-1 Infection in Antiretroviral Therapy Naive Adults

summary: This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Combivir in HIV infected, untreated subjects.

lead_sponsor: ViiV Healthcare

location_country:
Italy
United States
Spain
Germany
France
Belgium
Portugal
Canada
United Kingdom


title: A Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy

acronym: STRIDE-PD

summary: The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.

ReferenceCitation: Stocchi F, Rascol O, Kieburtz K, Poewe W, Jankovic J, Tolosa E, Barone P, Lang AE, Olanow CW. Initiating levodopa/carbidopa therapy with and without entacapone in early Parkinson disease: the STRIDE-PD study. Ann Neurol. 2010 Jul;68(1):18-27. doi: 10.1002/ana.22060. Erratum in: Ann Neurol. 2010 Sep;68(3):412-3.

family: Stocchi

full_name: Fabrizio Stocchi

given: Fabrizio

family: Rascol

full_name: Olivier Rascol

given: Olivier

family: Kieburtz

full_name: Karl Kieburtz

given: Karl

family: Poewe

full_name: Werner Poewe

given: Werner

family: Jankovic

full_name: Joseph Jankovic

given: Joseph

family: Tolosa

full_name: Eduardo Tolosa

given: Eduardo

family: Barone

full_name: Paulo Barone

given: Paulo

family: Lang

full_name: Anthony E. Lang

given: Anthony E.

family: Olanow

full_name: C. Warren Olanow

given: C. Warren

journal_name: Annals of Neurology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Initiating levodopa/carbidopa therapy with and without entacapone in early Parkinson disease: The STRIDE-PD study

lead_sponsor: Novartis Pharmaceuticals

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

location_facility: Duke University Medical Center Movement Disorders Center

location_facility: Parkinson's Disease and Movement Disorder Center of Albany Medical

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Wisconsin Institute for Neurologic and Sleep Disorders

location_facility: Parkinson's Disease and Movement Disorders Center of Long Island

location_facility: Baylor College of Medicine, Parkinson's Disease Center

location_facility: Columbia University, Neurological Institute

location_facility: Keck School of Medicine, Division of Movement Disorders


title: The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Patients With Moderate Hypertension

summary: The purpose of this clinical research is to learn if moderate hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.

enrollment_type: Anticipated

location_country:
United States
France
Russian Federation
Germany
Canada


title: A Multicenter Study to Evaluate the Effect of Rituximab (IDEC-102) on Primary Humoral Response, Recall Response, and Maintenance of Acquired Immunity to Specific Antigens

summary: The purpose of this study is to provide treatment for patients who have relapsed Non-Hodgkin's lymphoma (NHL) or refractory NHL, and to test the immunity of study subjects after receiving four treatments with rituximab.

lead_sponsor: Biogen

location_country:
Austria
Sweden
United Kingdom
Germany
France
Lithuania
Romania
Russian Federation
Turkey
United States
Czech Republic

location_facility: University of Texas Health Science Center at San Antonio


title: A Phase 3 Multicenter, Open Label, Randomized Study of XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors Not Amenable to Conventional Surgery

summary: The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.

lead_sponsor: Helsinn Healthcare SA

location_country:
Italy
United States
Germany
France
Poland
Hungary
Belgium
Russian Federation
Spain
Canada
United Kingdom

location_facility: Centre Hospitalier Universite de Montreal

location_facility: Klinikum Grosshadern der Ludwig Maximilians Universitaet

location_facility: Josephine Ford Cancer Center at Henry Ford Health System

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: Winship Cancer Institute, Emory University Hospital

location_facility: University of Alabama at Birmingham Comprehensive Cancer Center

location_facility: University of Wisconsin Comprehensive Cancer Center

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: University of California, Irvine Medical Center

location_facility: Medical Consultants, PC c/o Ball Cancer Center

location_facility: British Columbia Cancer Agency - Vancouver Centre

location_facility: Hospital Clinic i Provincial (Oncology Department)

location_facility: Cancer Research Center named after N.N. Blokhin, RAMS


title: A Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-Controlled Study of Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)

summary: During a heart bypass procedure, a substance called "complement" is activated by the body. This "complement activation" causes an inflammatory response that can lead to side affects such as chest pain, heart attacks, stroke, heart failure, or death. The purpose of this study is to find out if the study drug (pexelizumab), that blocks "complement activation," can reduce such side effects and be given safely to patients requiring the bypass procedure with the use of the heart-lung machine.

study_start_date_type: Actual

ReferenceCitation: Smith PK, Shernan SK, Chen JC, Carrier M, Verrier ED, Adams PX, Todaro TG, Muhlbaier LH, Levy JH; PRIMO-CABG II Investigators. Effects of C5 complement inhibitor pexelizumab on outcome in high-risk coronary artery bypass grafting: combined results from the PRIMO-CABG I and II trials. J Thorac Cardiovasc Surg. 2011 Jul;142(1):89-98. doi: 10.1016/j.jtcvs.2010.08.035. Epub 2010 Sep 28.

family: Smith

full_name: Peter K. Smith

given: Peter K.

family: Shernan

full_name: Stanton K. Shernan

given: Stanton K.

family: Chen

full_name: John C. Chen

given: John C.

family: Carrier

full_name: Michel Carrier

given: Michel

family: Verrier

full_name: Edward D. Verrier

given: Edward D.

family: Adams

full_name: Peter X. Adams

given: Peter X.

family: Todaro

full_name: Thomas G. Todaro

given: Thomas G.

family: Muhlbaier

full_name: Lawrence H. Muhlbaier

given: Lawrence H.

family: Levy

full_name: Jerrold H. Levy

given: Jerrold H.

journal_name: The Journal of Thoracic and Cardiovascular Surgery

title: Effects of C5 complement inhibitor pexelizumab on outcome in high-risk coronary artery bypass grafting: Combined results from the PRIMO-CABG I and II trials

lead_sponsor: Alexion Pharmaceuticals

location_country:
Germany
United States
France
Netherlands

location_facility: Veterans Administration Greater Los Angeles Healthcare Sysytem

location_facility: Veterans Administration (VA) Boston Healthcare System

location_facility: Kaiser Permanente Moanalua Medical Center

location_facility: University of Southern California University Hospital

location_facility: Cooper Health System/University Medical Center

location_facility: West Shore Cardiology Research Department

location_facility: Atlanta Veteran's Administration (VA) Medical Center

location_facility: Los Angeles County-University of Southern California Medical Center

location_facility: Zentrum fuer Herzchirurgie der Frederick-Alexander-Universitaet

location_facility: Cooper Hospital University Medical Center

location_facility: Southern Arizona Veterans Affairs Health Care System

location_facility: University of Colorado Health Sciences Center

location_facility: Michael E. DeBakey Veterans Affairs Medical Center

location_facility: University of Alabama at Birmingham Hospital

location_facility: St. Luke's Episcopal Hospital - Texas Heart

location_facility: University of California Irvine Medical Center

location_facility: Shands Hospital at the University of Florida

location_facility: Health First Holmes Regional Medical Center

location_facility: Clarian Health Partners, Inc. Methodist Hospital

location_facility: University of North Carolina at Chapel Hill Hospitals

location_facility: Veterans Administration Palo Alto Healthcare System


title: Linezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus

acronym: ZEPHYR

summary: To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin.

ReferenceCitation: Equils O, da Costa C, Wible M, Lipsky BA. The effect of diabetes mellitus on outcomes of patients with nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus: data from a prospective double-blind clinical trial comparing treatment with linezolid versus vancomycin. BMC Infect Dis. 2016 Sep 6;16:476. doi: 10.1186/s12879-016-1779-5.

family: Equils

full_name: Ozlem Equils

given: Ozlem

family: da Costa

full_name: Christopher da Costa

given: Christopher

family: Wible

full_name: Michele Wible

given: Michele

family: Lipsky

full_name: Benjamin A. Lipsky

given: Benjamin A.

journal_name: BMC Infectious Diseases

ReferenceCitation: Shorr AF, Puzniak LA, Biswas P, Niederman MS. Predictors of Clinical Success in the Treatment of Patients with Methicillin-Resistant Staphylococcus aureus (MRSA) Nosocomial Pneumonia (NP). PLoS One. 2015 Jul 21;10(7):e0131932. doi: 10.1371/journal.pone.0131932. eCollection 2015.

family: Shorr

full_name: Andrew F. Shorr

given: Andrew F.

family: Puzniak

full_name: Laura A. Puzniak

given: Laura A.

family: Biswas

full_name: Pinaki Biswas

given: Pinaki

family: Niederman

full_name: Michael S. Niederman

given: Michael S.

currency_apc_doaj: USD

journal_name: PLOS ONE

evidence: oa repository (semantic scholar lookup)

publisher: Public Library of Science (PLoS)

ReferenceCitation: Quartin AA, Scerpella EG, Puttagunta S, Kett DH. A comparison of microbiology and demographics among patients with healthcare-associated, hospital-acquired, and ventilator-associated pneumonia: a retrospective analysis of 1184 patients from a large, international study. BMC Infect Dis. 2013 Nov 27;13:561. doi: 10.1186/1471-2334-13-561.

ReferenceCitation: Puzniak LA, Morrow LE, Huang DB, Barreto JN. Impact of weight on treatment efficacy and safety in complicated skin and skin structure infections and nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus. Clin Ther. 2013 Oct;35(10):1557-70. doi: 10.1016/j.clinthera.2013.08.001. Epub 2013 Sep 3.

title: Impact of Weight on Treatment Efficacy and Safety in Complicated Skin and Skin Structure Infections and Nosocomial Pneumonia Caused by Methicillin-Resistant Staphylococcus aureus

location_country:
Malaysia
Greece
Belgium
Russian Federation
Taiwan
France
Poland
Argentina
Korea, Republic of
Colombia
South Africa
Chile
Hong Kong
Puerto Rico
Portugal
Germany
United States
United Kingdom
Brazil
Mexico
Spain
Turkey


title: A Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

summary: The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).

ReferenceCitation: Dudrick SJ, Latifi R, Fosnocht DE. Management of the short-bowel syndrome. Surg Clin North Am. 1991 Jun;71(3):625-43. Review.

ReferenceCitation: Rombeau JL, Rolandelli RH. Enteral and parenteral nutrition in patients with enteric fistulas and short bowel syndrome. Surg Clin North Am. 1987 Jun;67(3):551-71.

ReferenceCitation: Shanbhogue LK, Molenaar JC. Short bowel syndrome: metabolic and surgical management. Br J Surg. 1994 Apr;81(4):486-99. Review.

ReferenceCitation: Vanderhoof JA, Langnas AN. Short-bowel syndrome in children and adults. Gastroenterology. 1997 Nov;113(5):1767-78. Review.

ReferenceType: result

ReferenceCitation: Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B, O'Keefe SJ. Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut. 2011 Jul;60(7):902-14. doi: 10.1136/gut.2010.218271. Epub 2011 Feb 11.

family: Jeppesen

full_name: P. B. Jeppesen

given: P. B.

family: Gilroy

full_name: R. Gilroy

given: R.

family: Pertkiewicz

full_name: M. Pertkiewicz

given: M.

family: Allard

full_name: J. P. Allard

given: J. P.

family: Messing

full_name: B. Messing

given: B.

family: O'Keefe

full_name: S. J. O'Keefe

given: S. J.

journal_name: Gut

evidence: open (via page says license)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Fujioka K, Jeejeebhoy K, Pape UF, Li B, Youssef NN, Schneider SM. Patients With Short Bowel on Narcotics During 2 Randomized Trials Have Abdominal Complaints Independent of Teduglutide. JPEN J Parenter Enteral Nutr. 2017 Nov;41(8):1419-1422. doi: 10.1177/0148607116663481. Epub 2016 Aug 9.

name: Department of Diabetes and Endocrinology, Scripps Clinic, San Diego, California, USA

family: Fujioka

full_name: Ken Fujioka

given: Ken

name: Department of Medicine, St. Michael’s Hospital, Toronto, Ontario, Canada

family: Jeejeebhoy

full_name: Khursheed Jeejeebhoy

given: Khursheed

name: Department of Hepatology & Gastroenterology, Charité University Medicine, Berlin, Germany

family: Pape

full_name: Ulrich-Frank Pape

given: Ulrich-Frank

name: Department of Statistics, NPS Pharmaceuticals, Inc., Lexington, Massachusetts, USA

name: Amicus Therapeutics, Cranbury, New Jersey, USA, for BL and Digestive Healthcare Center, Hillsborough, New Jersey, USA, for NNY

family: Li

full_name: Benjamin Li

given: Benjamin

name: Clinical Research and Development, NPS Pharmaceuticals, Inc., Lexington, Massachusetts, USA

family: Youssef

full_name: Nader N. Youssef

given: Nader N.

name: Gastroenterology and Clinical Nutrition, University of Nice-Sophia Antipolis, Nice, France

family: Schneider

full_name: Stéphane M. Schneider

given: Stéphane M.

journal_name: Journal of Parenteral and Enteral Nutrition

location_country:
United States
Netherlands
Germany
France
Poland
Belgium
Denmark
Canada
United Kingdom

location_facility: University of Pennsylvania - Penn Nursing

location_facility: Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP

location_facility: Rigshospitalet, University of Copenhagen

location_facility: Northwestern Center for Clinical Research


title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis

summary: Clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for which no established efficacious treatment is available. The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO Class III and IV, to a new category of patients suffering from ILD associated with SSc.

ReferenceCitation: Liu C, Chen J, Gao Y, Deng B, Liu K. Endothelin receptor antagonists for pulmonary arterial hypertension. Cochrane Database Syst Rev. 2021 Mar 26;3:CD004434. doi: 10.1002/14651858.CD004434.pub6.

name: Division of Cardiology; The First Hospital of Hebei Medical University; Shijiazhuang China

family: Liu

full_name: Chao Liu

given: Chao

name: Department of Haematology and Rheumatology; The First Affiliated Hospital of Fujian Medical University; Fuzhou China

family: Chen

full_name: Junmin Chen

given: Junmin

family: Gao

full_name: Yanqiu Gao

given: Yanqiu

family: Deng

full_name: Bao Deng

given: Bao

full_name: Kunshen Liu

given: Kunshen

journal_name: Cochrane Database of Systematic Reviews

ReferenceCitation: Seibold JR, Denton CP, Furst DE, Guillevin L, Rubin LJ, Wells A, Matucci Cerinic M, Riemekasten G, Emery P, Chadha-Boreham H, Charef P, Roux S, Black CM. Randomized, prospective, placebo-controlled trial of bosentan in interstitial lung disease secondary to systemic sclerosis. Arthritis Rheum. 2010 Jul;62(7):2101-8. doi: 10.1002/art.27466. Erratum in: Arthritis Rheum. 2010 Oct;62(10):3005.

family: Seibold

full_name: J.R. Seibold

family: Denton

full_name: C.P. Denton

family: Furst

full_name: D.E. Furst

family: Guillevin

full_name: L. Guillevin

given: L.

family: Rubin

full_name: L.J. Rubin

family: Wells

full_name: A. Wells

given: A.

family: Matucci-Cerinic

full_name: M. Matucci-Cerinic

family: Riemekasten

full_name: G. Riemekasten

given: G.

family: Emery

full_name: P. Emery

given: P.

family: Chadha-Boreham

full_name: H. Chadha-Boreham

given: H.

family: Charef

full_name: P. Charef

family: Roux

full_name: S. Roux

given: S.

family: Korn

full_name: J. Korn

given: J.

family: Black

full_name: C.M. Black

journal_name: Arthritis & Rheumatism

lead_sponsor: Actelion

location_country:
Italy
United States
Sweden
Switzerland
Netherlands
France
Israel
Germany
United Kingdom

location_facility: University of Illinois College of Medicine

location_facility: University of Texas Houston Medical School


title: An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Fluorouracil/Leucovorin as Adjuvant Therapy for Patients Who Have Undergone Surgery for Colon Carcinoma, AJCC/UICC Stage III (Dukes Stage C)

summary: This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.

ReferenceCitation: Schmoll HJ, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Hoersch S, Rittweger K, Haller DG. Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer: Final Results of the NO16968 Randomized Controlled Phase III Trial. J Clin Oncol. 2015 Nov 10;33(32):3733-40. doi: 10.1200/JCO.2015.60.9107. Epub 2015 Aug 31.

name: Hans-Joachim Schmoll, Martin Luther University, Halle, Germany; Josep Tabernero, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain; Jean Maroun, Ottawa Regional Cancer Center, Ottawa, Ontario, Canada; Filippo de Braud, Istituto Europeo di Oncologia, Milan, Italy; Timothy Price, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia; Eric Van Cutsem, University Hospital Gasthuisberg, Leuven, Belgium; Mark Hill, Kent Oncology Centre, Maidstone, Kent, United...

family: Schmoll

full_name: Hans-Joachim Schmoll

given: Hans-Joachim

family: Tabernero

full_name: Josep Tabernero

given: Josep

family: Maroun

full_name: Jean Maroun

given: Jean

family: de Braud

full_name: Filippo de Braud

given: Filippo

family: Price

full_name: Timothy Price

given: Timothy

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

family: Hill

full_name: Mark Hill

given: Mark

family: Hoersch

full_name: Silke Hoersch

given: Silke

family: Rittweger

full_name: Karen Rittweger

given: Karen

family: Haller

full_name: Daniel G. Haller

given: Daniel G.

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Greece
Belgium
Australia
Russian Federation
Taiwan
France
Panama
Poland
Thailand
Canada
Korea, Republic of
South Africa
Hong Kong
Switzerland
Singapore
Hungary
Ireland
China
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Israel
New Zealand
Spain

location_facility: Uni of Pittsburgh Cancer Inst. ; Oncology

location_facility: Hospital Christus Muguerza Del Parque; Centro de Rehabilitacion

location_facility: Theageneio Anticancer Hospital; Gastroenterology

location_facility: North Wales Cancer Treatment Centre, Glan Clwyd Hospital

location_facility: Derriford Hospital; Plymouth Oncology Centre

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Klinika Nowotworow Jelita Grubego

location_facility: Ospedale Cervesi di Cattolica; ONCOLOGIA

location_facility: A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica

location_facility: Hanyang Uni Hospital; Dept. of Internal Medicine , Section of Hemato-Oncology

location_facility: Instituto Nacional De Ciencias Medicas Y Nutricion; Nefrology

location_facility: N.N.Burdenko Main Military Clinical Hospital; Chemotherapy

location_facility: Petrov Research Inst. of Oncology; Dept of Bio-Therapy & Transplantation of Bone Marrow

location_facility: Orszagos Onkologial Intezet; Onkologiai Osztaly X

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Sourasky / Ichilov Hospital; Oncology Department

location_facility: Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center

location_facility: West Valley Hematology Oncology The Thomas and Dorothy Leavey Cancer Center

location_facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc.

location_facility: University Hospital of Patras Medical Oncology

location_facility: Hospital Severo Ochoa; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Royal Prince Alfred Hospital; Medical Oncology

location_facility: Theagenio Anticancer Hospital; 3Rd Oncology Clinic

location_facility: Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical

location_facility: Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology

location_facility: Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

location_facility: Innovative clinical research institute/American institute of research

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: The Royal Sussex County Hospital; the Sussex Cancer Centre

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Royal Marsden Nhs Trust; Consultant Cancer Physician

location_facility: Addenbrooke'S Hospital; Univ.Dept.& Mrc Unit of Clin.Oncology & Radiotherapeutics

location_facility: Mount Vernon Hospital; Centre For Cancer Treatment

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Clinica de Especialidades # 30 Dr. Humberto Torres Sangines; Oncology

location_facility: Dunedin Hospital; Oncology - Haematology Clinical Practice Group

location_facility: Hammersmith Hospital; Mrc Clinical Science Centre

location_facility: Salisbury District General Hospital; Medical Oncology Dept

location_facility: Hospital das Clinicas - FMUSP; Gastroenterologia

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Bumrungrad Hospital Foundation; Horizon Centre

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: St. Vincent'S Hospital; Comprehensive Care Center

location_facility: Internal Medicine Associates of Yakima Inc.

location_facility: Chuq - Hopital Hotel Dieu de Quebec; Oncology

location_facility: Northern Centre for Cancer Care;Oncology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

location_facility: UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center

location_facility: Central Hematology Oncology Medical Group Inc.

location_facility: St. Petersburg City Clinical Oncological Dispensary; Colorectal (Department 4)

location_facility: Isthmian Medical Research Center, S.A.; Oncology

location_facility: Morristown Medical Center;Hematology-Oncology Assoc

location_facility: National Cancer Centre; Medical Oncology

location_facility: University of Colorado Health Science Center; Biomedical Research Bldg. Room 511

location_facility: Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Charing Cross Hospital; Medical Oncology.

location_facility: Lubuski Osrodek Onkologii, Szpital Wojewodzki; Oddzial Onkologii

location_facility: St John of God Hospital; Medical Oncology

location_facility: Universitaetsklinikum Halle; Klinik u.Poliklinik fuer Innere Medizin IV

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Hospital de Baleia; Serviço de Oncologia Clínica

location_facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

location_facility: Wojewodzki Szpital Specjalistyczny Im. M. Kopernika; Oddzial Chorob Rozrostowych

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Little Company of Mary Hospital; Mary Potter Oncology Centre

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Bcca - Vancouver Island Cancer Centre; Oncology

location_facility: New Mexico Oncology Hematology Consultants

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology

location_facility: Per. Gen. Hospital Ippokrateion; Oncology Dept.

location_facility: Palmerston North Hospital; Regional Cancer Treatment Service

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Ospedale Civile; Unita Operativa Di Oncologia Medica

location_facility: Dr. H. Bliss Murphy Cancer Centre; Oncology

location_facility: Kaiser Permanente San Diego; Hepatology Research

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Mercy Uni Hospital; Deparment of Medical Oncology

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Ospedale Degli Infermi; Divisione Di Oncologia

location_facility: Hospital Jose Joaquim Fernandes; Unidade de Oncologia Medica

location_facility: Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Hematology-Oncology Centers of the Northern Rockies

location_facility: The 1st Affiliated Hospital of Nanchang Unversity

location_facility: Derbyshire Royal Infirmary; Dept of Oncology

location_facility: Hopital Claude Huriez; Medecine Interne Oncologie

location_facility: West Suffolk Hospital Nhs Trust; Gi Corridor

location_facility: Wellington Hospital; Regional Oncology Unit

location_facility: Southampton General Hospital; Somers Cancer Research Building

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

location_facility: Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Carolina Oncology Specialists, PA - Hickory

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Oncology-Hematology of Lehigh Valley, Pc

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Southern Medical Day Care; Clinical Trials Unit

location_facility: Hopital Du Sacre Coeur de Montreal; Pneumologie

location_facility: The Second Affiliated Hospital of Zhejiang University College

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Aberdeen Royal Infirmary; Medical Oncology Dept

location_facility: Overlook Oncology Center; Summit Medical Group

location_facility: Presbyterian Healthcare; Cancer Research Dept

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Hospital Universitario de la Princesa; Servicio de Oncologia

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Cruk Clinical Trials Unit; Level 0 Beatson West Of Scotland Cancer Ctr

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

location_facility: Tom Baker Cancer Centre; Dept of Medicine

location_facility: Srinagarind Hospital; Medical Oncology Unit

location_facility: Pramongkutklao Hospital; Medicine - Medical Oncology Unit

location_facility: Queen Elizabeth Hospital; Medical Oncology

location_facility: Georgetown Uni Medical Center; Lombardi Cancer Center

location_facility: Royal Surrey County Hospital; St. Lukes Cancer Centre

location_facility: Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X

location_facility: Hopelands Cancer Centre ST. ANNES HOSPITAL; DEPT. OF ONCOLOGY


title: A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs. Exemestane (AROMASIN™) in Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer With Disease Progression After Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy

acronym: EFECT

summary: The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.

lead_sponsor: AstraZeneca

location_country:
United States
Brazil
South Africa
Sweden
Germany
France
Israel
Hungary
Belgium
Argentina
Russian Federation
Spain
Denmark
Canada
United Kingdom


title: Revised Protocol 07 to Protocol CA225006 - A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Carcinoma

summary: The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Austria
Sweden
Hong Kong
Netherlands
Switzerland
Germany
United Kingdom
Finland
France
Slovakia
Norway
Australia
Belgium
Portugal
United States
Czech Republic


title: The Van Gogh-PE Trial, a Multicenter, International, Randomized, Open-Label, Assessor-Blind, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous SR34006 With the Combination of (LMW)Heparin and Vitamin K Antagonist (VKA) in the Treatment of Acute Symptomatic Pulmonary Embolism

summary:
Patients who have a pulmonary embolism (blood clot in the lung) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood-thinning) drug, SR34006, with the standard way of treating a pulmonary embolism. The standard treatment includes injections or infusions of an anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth.

Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors.

ReferenceCitation: Prins MH, Guillemin I, Gilet H, Gabriel S, Essers B, Raskob G, Kahn SR. Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q). Health Qual Life Outcomes. 2009 Apr 7;7:30. doi: 10.1186/1477-7525-7-30.

family: Prins

full_name: MH Prins

given: MH

family: Guillemin

full_name: I Guillemin

given: I

family: Gilet

full_name: H Gilet

given: H

family: Gabriel

full_name: S Gabriel

given: S

family: Essers

full_name: B Essers

given: B

family: Raskob

full_name: G Raskob

given: G

family: Kahn

full_name: SR Kahn

given: SR

journal_name: Health and Quality of Life Outcomes

publisher_dissemination: Springer

publisher_group: Springer

title: Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q©)

ReferenceCitation: van Gogh Investigators, Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med. 2007 Sep 13;357(11):1094-104.

lead_sponsor: Sanofi

location_country:
Italy
Austria
Brazil
Sweden
Switzerland
Netherlands
United Kingdom
Germany
Finland
France
Poland
Norway
Argentina
Australia
Belgium
Spain
Denmark
United States
Czech Republic
Canada

location_facility: University of California, San Diego Medical Center

location_facility: Loyola University Medical Center and Outpatient Clinic

location_facility: The University of Texas Health Center at Tyler

location_facility: Hamilton Health Sciences - General Hospital

location_facility: University Health Network, Toronto General Hospital

location_facility: Lovelace Health Systems, Clinical Thrombosis Center

location_facility: Scott & White Memorial Hospital & Clinic

location_facility: Pulmonary Associates of Fredericksburg, Inc.


title: A Double Blind- Randomized, Placebo-controlled Study of Two Doses of Capravirine (AG1549) in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Infected Patients Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen

summary: This is a 48 week study that is intended for HIV Infected persons whose first treatment regimen was with a nonnucleoside reverse transcriptase inhibitor (NNRTI) and who are now failing that regimen. They must be currently on their failing regimen to be eligible.

lead_sponsor: Pfizer

location_country:
Italy
United States
South Africa
France
Spain
Germany


title: Randomized Phase III Trial Comparing Targretin Capsules/Cisplatin/Vinorelbine Versus Cisplatin/Vinorelbine in Chemotherapy-Naive Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

summary: This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

lead_sponsor: Eisai Inc.

location_country:
United States
United Kingdom
France
Poland
Greece
Israel
Hungary
Australia
Russian Federation
Canada
Czech Republic

location_facility: Koranyi National Institute for Pulmonology

location_facility: Semmelweis University Department of Pulmonology

location_facility: Louisiana State University Health Science Center

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

location_facility: Research Institute of Oncology n.a. Petrov

location_facility: Research Institute of Oncology n.a. Hertzen

location_facility: 6th Pneumonology Department, Sotiria Hospital for Diseases of the Chest

location_facility: 1st Pulmonary Clinic of G. Papanikolaou Hospital

location_facility: 7th Pneumonology Clinic, Sotiria Hospital for Diseases of the Chest

location_facility: Centre Hospitalier Intercommunal de la Haute-Saone

location_facility: Klinika pneumologie a hrudni chirurgie 3.LF

location_facility: University Oncology & Hematology Associates

location_facility: Wielkopolskie Centrum Chorob Pluc I Gruzlicy

location_facility: Russian Oncology Research Center n.a. Blokhin

location_facility: Desert Hematology-Oncology Medical Group, Inc.

location_facility: Capitol Comprehensive Cancer Care Clinic

location_facility: University General Hospital of Heraklion

location_facility: 2nd Pulmonary Clinic of G. Papanikolaou Hospital

location_facility: Fovarosi Onkormanyzat Uzsoki utcai, Korhaza

location_facility: St. Petersburg Pavlov State Medical University


summary: The purpose of this study is to determine if patients who take YM598 in addition to mitoxantrone and prednisone (standard therapy) experience improvement in the pain associated with prostate cancer metastases in the bone.

lead_sponsor: Astellas Pharma Inc

location_country:
Netherlands
Germany
France
Poland
Ireland
Belgium
Australia
Spain
United States
United Kingdom

location_facility: Department of Medical Oncology, Concord Hospital Medical Centre

location_facility: University of Illinois, Department of Urology

location_facility: Division of Oncology Ward, Royal Brisbane Hospital

location_facility: Imperial College School of Medicine, Dept Cancer Medicine

location_facility: Krankenhause am Urban, Urologie Dieffenfachstr

location_facility: Cliniques Universitaires St-Luc, Service d'Urologie

location_facility: Hospital General Vall d'Hebron, Servicio de Oncología

location_facility: Clinical Research Centre, St George's Hospital, Urology Division

location_facility: Department of Urology, St Bartholomew's Hospital

location_facility: Pavillon V, Service d'Urologie et de transplatation, Hôpital Edouard Herriot

location_facility: Washington University School of Medicine

location_facility: University of Chicago, Section of Hematology/Oncology

location_facility: Queen Elizabeth Hospital, Clinical Hematology & Oncology

location_facility: Department of Medical Oncology, Newcastle Mater Hospital

location_facility: Department of Medical Oncology, The Canberra Hospital

location_facility: Kilinika Chemioterapii, Centrum Onkologii Instytut im M sklodowskiej Curie

location_facility: Szpital Wojewodzki im Sw Lukasza SP ZOZ Tarnow

location_facility: Instituto Valenciano de Oncologia, Servicio de Oncologia

location_facility: Hospital Universitario de Getafe, Servicio de Urologia, Crta

location_facility: Department of Urological Research, Derriford Hospital

location_facility: Hospital Universitario Príncipe de Asturias, Servicio de Urología

location_facility: Department of Clinical Oncology, Royal North Shore Hospital

location_facility: Service d'Urologie, Hôpital Henri Mondor

location_facility: Samodzielny Publiczny Zaklad Opieki zdrowotnej, Wojewodzki Osrodek Onkologii

location_facility: Centre Hospitalier Notre Dame et Reine Fabiola, Service d'oncologie

location_facility: Department of Urology, East Surrey Hospital

location_facility: Universitair Medisch Centrum Utrecht, Dienst Medische Oncologie

location_facility: Hospital Clinic i Provincial, Servicio de Oncologia


title: A Phase II, Randomized, Partially-Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of 12 Weeks of Treatment with Clevudine (10 mg, 30 mg or 50 mg QD) in Patients Infected with Hepatitis B Virus.

summary: The purpose of the study is to evaluate the safety and effectiveness of 12 weeks of treatment with clevudine, at one of three doses, in patients chronically infected with hepatitis B virus.

status: Unknown status

lead_sponsor: Triangle Pharmaceuticals

location_country:
France
Singapore
China
United States
Canada

location_facility: Hospital Beaujon, Service Hepatologie Centre Pierre Abrami

location_facility: Prince of Wales Hospital, Department of Medicine and Therapeutics

location_facility: Hospital de Brabois Chu de Nancy, Service d'Hepato-gastroenterologie

location_facility: Thomas Jefferson University Hospital, Jefferson Medical College

location_facility: Hospital Dieu, Service Hepatogastroenterologie-endoscopie

location_facility: The University of Hong Kong, Clinical Trials Centre, Faculty of Medicine, Queen Mary Hospital

location_facility: Hospital St Louis, Service de Medecine Interne

location_facility: National University Hospital, Division of Gastroenterology, Department of Medicine

location_facility: University of British Columbia, Downtown Infectious Disease Clinic


title: An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer.

summary: This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. The other treatment will use a combination of two FDA approved chemotherapy drugs.

location_country:
Finland
Belgium
Russian Federation
Czech Republic
Taiwan
Costa Rica
France
Panama
Lithuania
Poland
Slovakia
Norway
Canada
Korea, Republic of
South Africa
Chile
Netherlands
Jamaica
Bulgaria
Singapore
Hungary
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Honduras
Mexico
New Zealand
Spain
Estonia


title: CLOCC Trial (Chemotherapy + Local Ablation Versus Chemotherapy) Randomized Phase II Study Of Local Treatment Of Liver Metastases By Radiofrequency Combined With Chemotherapy Versus Chemotherapy Alone In Patients With Unresectable Colorectal Liver Metastases

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread by blocking blood flow. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. It is not yet known if chemotherapy is more effective with or without radiofrequency ablation in treating liver metastases.

PURPOSE: This randomized phase II trial is studying combination chemotherapy, bevacizumab, and radiofrequency ablation to see how well they work compared to combination chemotherapy and bevacizumab alone in treating unresectable liver metastases in patients with colorectal cancer.

ReferenceCitation: Ruers T, van Coevorden F, Pierie J, et al.: Radiofrequency ablation (RFA) combined with chemotherapy for unresectable colorectal liver metastases (CRC LM): interim results of a randomised phase II study of the EORTC-NCRI CCSG-ALM Intergroup 40004 (CLOCC). [Abstract] J Clin Oncol 26 (Suppl 15): A-9535, 2008.

ReferenceCitation: Ruers T, Punt C, Van Coevorden F, Pierie JPEN, Borel-Rinkes I, Ledermann JA, Poston G, Bechstein W, Lentz MA, Mauer M, Van Cutsem E, Lutz MP, Nordlinger B; EORTC Gastro-Intestinal Tract Cancer Group; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO) and the National Cancer Research Institute Colorectal Clinical Study Group (NCRI CCSG). Radiofrequency ablation combined with systemic treatment versus systemic treatment alone in patients with non-resectable colorectal liver metastases: a randomized EORTC Intergroup phase II study (EORTC 40004). Ann Oncol. 2012 Oct;23(10):2619-2626. doi: 10.1093/annonc/mds053. Epub 2012 Mar 19.

family: Ruers

full_name: T. Ruers

given: T.

family: Punt

full_name: C. Punt

given: C.

family: Van Coevorden

full_name: F. Van Coevorden

given: F.

family: Pierie

full_name: J.P.E.N. Pierie

family: Borel-Rinkes

full_name: I. Borel-Rinkes

given: I.

family: Ledermann

full_name: J.A. Ledermann

family: Poston

full_name: G. Poston

given: G.

family: Bechstein

full_name: W. Bechstein

given: W.

family: Lentz

full_name: M.A. Lentz

family: Mauer

full_name: M. Mauer

given: M.

full_name: E. Van Cutsem

given: E.

family: Lutz

full_name: M.P. Lutz

family: Nordlinger

full_name: B. Nordlinger

given: B.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Italy
Austria
Sweden
Netherlands
France
Hungary
Belgium
Egypt
Germany
United Kingdom

location_facility: Staedtische Kliniken Frankfurt am Main - Hoechst

location_facility: Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

location_facility: Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Azienda Ospedaliera S. Camillo-Forlanini

location_facility: Sahlgrenska University Hospital at Gothenburg University

location_facility: Karolinska University Hospital - Huddinge

location_facility: Cancer Research UK and University College London Cancer Trials Centre

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Velindre Cancer Center at Velindre Hospital

location_facility: Centre Hospitalier Universitaire Ambroise Pare - Boulogne

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

intervention_type: Procedure


title: A Multi-center, Double-Blind, Randomized, Parallel-Group Trial to Compare the Efficacy and Safety of Three Doses of Meloxicam (7.5, 15, and 22.5 mg) and Placebo in Patients With Rheumatoid Arthritis

summary: A 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective and safe three different doses of meloxicam are compared with placebo in Rheumatoid Arthritis. Patient will take one dose of study medication daily.

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Brazil
Germany
France
Korea, Republic of
Hungary
Belgium
Argentina
Australia
Russian Federation
United States
Canada
Taiwan
Ukraine

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: National Institute for Rheumatology and Physiotherapy

location_facility: Università degli Studi di Napoli "Federico II"

location_facility: Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia

location_facility: Boehringer Ingelheim Investigational Site

location_facility: Rheumatologie und Physikalische Therapie


title: A Multi-Center, Randomized Phase III Study of Adjuvant Oncophage® Versus Observation in Subjects With High Risk of Recurrence After Surgical Treatment for Renal Cell Carcinoma

summary: Determine whether patients receiving adjuvant HSPPC-96 treatment after surgically resected, locally advanced renal cell carcinoma have improved recurrence-free survival as compared to subjects with no adjuvant treatment.

ReferenceCitation: Wood C, Srivastava P, Bukowski R, Lacombe L, Gorelov AI, Gorelov S, Mulders P, Zielinski H, Hoos A, Teofilovici F, Isakov L, Flanigan R, Figlin R, Gupta R, Escudier B; C-100-12 RCC Study Group. An adjuvant autologous therapeutic vaccine (HSPPC-96; vitespen) versus observation alone for patients at high risk of recurrence after nephrectomy for renal cell carcinoma: a multicentre, open-label, randomised phase III trial. Lancet. 2008 Jul 12;372(9633):145-154. doi: 10.1016/S0140-6736(08)60697-2. Epub 2008 Jul 3.

family: Wood

full_name: Christopher Wood

given: Christopher

family: Srivastava

full_name: Pramod Srivastava

given: Pramod

family: Bukowski

full_name: Ronald Bukowski

given: Ronald

family: Lacombe

full_name: Louis Lacombe

given: Louis

family: Gorelov

full_name: Andrei I Gorelov

given: Andrei I

full_name: Sergei Gorelov

given: Sergei

family: Mulders

full_name: Peter Mulders

given: Peter

family: Zielinski

full_name: Henryk Zielinski

given: Henryk

family: Hoos

full_name: Axel Hoos

given: Axel

family: Teofilovici

full_name: Florentina Teofilovici

given: Florentina

family: Isakov

full_name: Leah Isakov

given: Leah

family: Flanigan

full_name: Robert Flanigan

given: Robert

family: Figlin

full_name: Robert Figlin

family: Gupta

full_name: Renu Gupta

given: Renu

family: Escudier

full_name: Bernard Escudier

given: Bernard

journal_name: The Lancet

lead_sponsor: Agenus Inc.

location_country:
Austria
United States
Sweden
France
Poland
Israel
Norway
Belgium
Spain
Canada
United Kingdom


title: A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the brain with or without RSR13 in treating patients who have brain metastases.

ReferenceCitation: Suh JH, Stea B, Nabid A, Kresl JJ, Fortin A, Mercier JP, Senzer N, Chang EL, Boyd AP, Cagnoni PJ, Shaw E. Phase III study of efaproxiral as an adjunct to whole-brain radiation therapy for brain metastases. J Clin Oncol. 2006 Jan 1;24(1):106-14. Epub 2005 Nov 28.

ReferenceCitation: Nabid A, Kresl J, Stea B, et al.: Standard whole brain radiation (WBRT) with supplemental oxygen (O2) with or without RSR13 (efaproxiral) in patients with brain metastases originating from NSCLC: results of a subgroup analysis. [Abstract] J Clin Oncol 22 (Suppl 14): A-7115, 645s, 2004.

ReferenceCitation: Shaw E, Stea B, Pinter T, et al.: Pharmacokinetics (PK) of RSR13 (efaproxiral) predict survival in patients with brain metastases randomized to receive whole brain radiation therapy (WBRT) with or without RSR13 (REACH RT-009). [Abstract] J Clin Oncol 22 (Suppl 14): A-1561, 122s, 2004.

ReferenceCitation: Stea B, Suh J, Shaw E, et al.: Efaproxiral (EFAPROXYN) as an adjunct to whole brain radiation therapy for the treatment of brain metastases originating from breast cancer: updated survival results of the randomized REACH (RT-009) study. [Abstract] Breast Cancer Res Treat 88 (1): A-4064, 2004.

ReferenceCitation: Suh J, Stea BD, Nabid A, et al.: Prognostic factors for survival in patients with brain metastases enrolled on a worldwide phase 3 randomized trial of 538 patients (study RSR13 RT-009). [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-60, S165, 2004.

ReferenceCitation: Suh J, Stea B, Nabid A, et al.: Standard whole brain radiation therapy (WBRT) with supplemental oxygen (O2), with or without RSR13 (efaproxiral) in patients with brain metastases: results of the randomized REACH (RT-009) study. [Abstract] J Clin Oncol 22 (Suppl 14): A-1534, 115s, 2004.

lead_sponsor: Spectrum Pharmaceuticals, Inc

location_country:
Italy
United States
Germany
France
Hungary
Belgium
Australia
Canada
United Kingdom

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Cooper Hospital/University Medical Center

location_facility: State University of New York - Upstate Medical University

location_facility: British Columbia Cancer Agency - Fraser Valley Cancer Centre

location_facility: Newfoundland Cancer Treatment and Research Foundation

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: University of Texas - MD Anderson Cancer Center

location_facility: Comprehensive Cancer Center at Wake Forest University

location_facility: Veterans Affairs Medical Center - Milwaukee (Zablocki)

location_facility: Royal Prince Alfred Hospital Medical Center

location_facility: Centre Hospitalier Universitaire de Quebec

location_facility: Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group

location_facility: Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

location_facility: Decatur Memorial Hospital Cancer Care Institute

location_facility: Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

location_facility: Comprehensive Cancer Care Specialists of Boca Raton

location_facility: St. Joseph's Hospital and Medical Center

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

intervention_type: Radiation


title: A Randomized, Double-Blind, Phase III Study of ABT-378/Ritonavir Plus Stavudine and Lamivudine vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects

summary:
The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with another PI, nelfinavir (NFV).

Earlier studies suggest ABT-378/RTV will be just as good as and perhaps better than NFV at fighting HIV infection.

ReferenceCitation: Murphy RL, Brun S, Hicks C, Eron JJ, Gulick R, King M, White AC Jr, Benson C, Thompson M, Kessler HA, Hammer S, Bertz R, Hsu A, Japour A, Sun E. ABT-378/ritonavir plus stavudine and lamivudine for the treatment of antiretroviral-naive adults with HIV-1 infection: 48-week results. AIDS. 2001 Jan 5;15(1):F1-9.

lead_sponsor: Abbott

location_country:
Austria
United States
Brazil
South Africa
Switzerland
Germany
France
Poland
Australia
Puerto Rico
Spain
Denmark
Canada
United Kingdom

location_facility: Holmes Hosp / Univ of Cincinnati Med Ctr

location_facility: East Orange Veterans Administration Med Ctr

location_facility: Univ of Michigan Hospitals and Health Ctrs

location_facility: Cornell Clinical Trials Unit - Chelsea Clinic

location_facility: Division of Inf Diseases/ Indiana Univ Hosp

location_facility: Groupe Hospitalier Bichat-Claude Bernard

location_facility: Community Research Initiative of New England

location_facility: SUNY at Stony Brook / Div of Infectious Disease

location_facility: Duke Univ Med Ctr / Infectious Disease Clinic

location_facility: San Francisco Veterans Administration Med Ctr

location_facility: Hosp Do Servidor Publico Estadual De Sao Paulo

location_facility: Klinikum Der Johann Wolfgang Goethe Universitat

location_facility: Orange County Ctr for Special Immunology


title: A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects

summary: The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).

location_facility: SUNY / Health Sciences Ctr at Stony Brook

location_facility: Saint Michael's Med Ctr / Dept of Infectious Diseases

location_facility: Univ of Utah Med School / Clinical Trials Ctr