title: A Comparison of Telmisartan 80 mg + Hydrochlorothiazide 12.5 mg With Amlodipine 10 mg + Hydrochlorothiazide 12.5 mg in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension. A Prospective, Randomised, Open-label, Blinded End-point Evaluation. (ATHOS Study)

summary: The primary objective of this study was test non-inferiority of telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg in comparison to amlodipine 10 mg + HCTZ 12.5 mg in reducing ambulatory systolic blood pressure (SBP) in the last 6 hours of the 24-hour dosing interval (determined by ambulatory blood pressure monitoring: ABPM) in elderly patients with predominantly systolic hypertension.

location_country:
Italy
South Africa
Netherlands
Finland
France
Ireland
Belgium
Spain
Denmark
Germany

location_facility: Azienda Ospedaliera "Maggiore della Carità"

location_facility: Hämeenlinnan lääkäriasema Oy, Linnan klinikka

location_facility: Adelaide and Meath Hospitals (incorrporating NCH)


title: A Randomized, Double-Blind, Dose Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects With Type 2 Diabetes

summary: A Randomized, Double-Blind, Dose-Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects with Type 2 Diabetes

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Rubin CJ, Viraswami-Appanna K, Fiedorek FT. Efficacy and safety of muraglitazar: a double-blind, 24-week, dose-ranging study in patients with type 2 diabetes. Diab Vasc Dis Res. 2009 Jul;6(3):205-15. doi: 10.1177/1479164109336048.

family: Rubin

full_name: Cindy J. Rubin

given: Cindy J.

sequence: first

name: Pharmaceutical Research Institute, Bristol-Myers Squibb, Princeton, New Jersey, USA, Biostatistics and Statistical Reporting, Novartis Pharmaceutical Corporation, USA

family: Viraswami-Appanna

full_name: Kalyanee Viraswami-Appanna

given: Kalyanee

sequence: additional

family: Fiedorek

full_name: Fred T. Fiedorek

given: Fred T.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Diabetes and Vascular Disease Research

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Brazil
United States
South Africa
Sweden
United Kingdom
Mexico
Netherlands
France
Poland
Argentina
Australia
Puerto Rico
Spain
Canada
Czech Republic

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Extension of Protocol HMR1726D/2001, A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

summary: The primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects. The secondary objective is to assess the long-term efficacy.

enrollment_type: Actual

ReferenceCitation: Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.

family: Comi

full_name: Giancarlo Comi

given: Giancarlo

family: Freedman

full_name: Mark S. Freedman

given: Mark S.

family: Meca-Lallana

full_name: José E. Meca-Lallana

given: José E.

family: Vermersch

full_name: Patrick Vermersch

given: Patrick

family: Kim

full_name: Byoung Joon Kim

given: Byoung Joon

family: Parajeles

full_name: Alexander Parajeles

given: Alexander

family: Edwards

full_name: Keith R. Edwards

given: Keith R.

family: Gold

full_name: Ralf Gold

given: Ralf

family: Korideck

full_name: Houari Korideck

given: Houari

family: Chavin

full_name: Jeffrey Chavin

given: Jeffrey

family: Poole

full_name: Elizabeth M. Poole

given: Elizabeth M.

family: Coyle

full_name: Patricia K. Coyle

given: Patricia K.

currency_apc_doaj: GBP

journal_name: BMC Neurology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: University of Ottawa - uO Research

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Confavreux C, Li DK, Freedman MS, Truffinet P, Benzerdjeb H, Wang D, Bar-Or A, Traboulsee AL, Reiman LE, O'Connor PW; Teriflunomide Multiple Sclerosis Trial Group. Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years. Mult Scler. 2012 Sep;18(9):1278-89. Epub 2012 Feb 3.

lead_sponsor: Sanofi

location_country: Canada France

location_facility:
Investigational Site Number 27
Investigational Site Number 10
Investigational Site Number 24
Investigational Site Number 30
Investigational Site Number 12
Investigational Site Number 11
Investigational Site Number 15
Investigational Site Number 19
Investigational Site Number 17
Investigational Site Number 16
Investigational Site Number 18
Investigational Site Number 23
Investigational Site Number 21
Investigational Site Number 13
Investigational Site Number 28
Investigational Site Number 14


title: Early Versus Late Initiation of Treatment With Risperdal Consta in Subjects With Schizophrenia After an Acute Episode

summary: The primary objective of this randomized trial was to investigate whether early initiation of treatment with Risperdal Consta after an acute episode was not inferior to the routine approach (oral treatment for 12 weeks followed by treatment with Risperdal Consta). .

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Sweden
Switzerland
United Kingdom
Finland
France
Greece
Israel
Norway
Denmark
Slovenia


title: A Prospective Multi-Centre Randomised, Double-Blind, Active Comparator-Controlled, Parallel-Groups Study Comparing the Fully Human Monoclonal Anti-TNFα Antibody Adalimumab Given Every Second Week With Methotrexate Given Weekly and the Combination of Adalimumab and Methotrexate Administered Over 2 Years in Patients With Early Rheumatoid Arthritis (PREMIER).

acronym: PREMIER

summary: The purpose of the study is to assess the safety and efficacy of adalimumab in combination with methotrexate in patients with recent onset rheumatoid arthritis (RA), and to assess the long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10 years.

ReferenceCitation: Smolen J, Fleischmann R, Aletaha D, Li Y, Zhou Y, Sainsbury I, Galindo IL. Disease activity improvements with optimal discriminatory ability between treatment arms: applicability in early and established rheumatoid arthritis clinical trials. Arthritis Res Ther. 2019 Nov 10;21(1):231. doi: 10.1186/s13075-019-2005-9.

family: Smolen

full_name: Josef Smolen

given: Josef

family: Fleischmann

full_name: Roy Fleischmann

given: Roy

family: Aletaha

full_name: Daniel Aletaha

given: Daniel

family: Li

full_name: Yihan Li

given: Yihan

family: Zhou

full_name: Yijie Zhou

given: Yijie

family: Sainsbury

full_name: Iain Sainsbury

given: Iain

family: Galindo

full_name: Ivan Lagunes Galindo

given: Ivan Lagunes

journal_name: Arthritis Research & Therapy

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Smolen JS, van Vollenhoven RF, Florentinus S, Chen S, Suboticki JL, Kavanaugh A. Predictors of disease activity and structural progression after treatment with adalimumab plus methotrexate or continued methotrexate monotherapy in patients with early rheumatoid arthritis and suboptimal response to methotrexate. Ann Rheum Dis. 2018 Nov;77(11):1566-1572. doi: 10.1136/annrheumdis-2018-213502. Epub 2018 Aug 3.

full_name: Josef S Smolen

given: Josef S

family: van Vollenhoven

full_name: Ronald F van Vollenhoven

given: Ronald F

family: Florentinus

full_name: Stefan Florentinus

given: Stefan

family: Chen

full_name: Su Chen

given: Su

family: Suboticki

full_name: Jessica L Suboticki

given: Jessica L

family: Kavanaugh

full_name: Arthur Kavanaugh

given: Arthur

journal_name: Annals of the Rheumatic Diseases

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

ReferenceCitation: Keystone EC, Breedveld FC, Kupper H, Li Y, Florentinus S, Sainsbury I. Long-term use of adalimumab as monotherapy after attainment of low disease activity with adalimumab plus methotrexate in patients with rheumatoid arthritis. RMD Open. 2018 Jun 13;4(1):e000637. doi: 10.1136/rmdopen-2017-000637. eCollection 2018.

ReferenceCitation: Keystone EC, Breedveld FC, van der Heijde D, van Vollenhoven RF, Emery P, Smolen JS, Sainsbury I, Florentinus S, Kupper H, Chen K, Kavanaugh A. Achieving comprehensive disease control in patients with early and established rheumatoid arthritis treated with adalimumab plus methotrexate versus methotrexate alone. RMD Open. 2017 Sep 26;3(2):e000445. doi: 10.1136/rmdopen-2017-000445. eCollection 2017.

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

ReferenceCitation: Möller B, Everts-Graber J, Florentinus S, Li Y, Kupper H, Finckh A. Low Hemoglobin and Radiographic Damage Progression in Early Rheumatoid Arthritis: Secondary Analysis From a Phase III Trial. Arthritis Care Res (Hoboken). 2018 Jun;70(6):861-868. doi: 10.1002/acr.23427. Epub 2018 Apr 25.

name: University Hospital of Bern; Bern Switzerland

name: AbbVie Deutschland; Ludwigshafen Germany

name: University Hospital of Geneva; Geneva Switzerland

ReferenceCitation: Burmester GR, Landewé R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Landewé R, Smolen JS, Florentinus S, Chen S, Guérette B, van der Heijde D. Existing joint erosions increase the risk of joint space narrowing independently of clinical synovitis in patients with early rheumatoid arthritis. Arthritis Res Ther. 2015 May 21;17:133. doi: 10.1186/s13075-015-0626-1.

ReferenceCitation: Landewé R, Østergaard M, Keystone EC, Florentinus S, Liu S, van der Heijde D. Analysis of integrated radiographic data from two long-term, open-label extension studies of adalimumab for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2015 Feb;67(2):180-6. doi: 10.1002/acr.22426.

name: Academic Medical Center; Amsterdam The Netherlands

name: Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Glostrup Hospital, Glostrup, and University of Copenhagen; Copenhagen Denmark

name: University of Toronto, Toronto; Ontario Canada

name: Leiden University Medical Center; Leiden The Netherlands

title: Analysis of Integrated Radiographic Data From Two Long-Term, Open-Label Extension Studies of Adalimumab for the Treatment of Rheumatoid Arthritis

ReferenceCitation: Keystone EC, Haraoui B, Guérette B, Mozaffarian N, Liu S, Kavanaugh A. Clinical, functional, and radiographic implications of time to treatment response in patients with early rheumatoid arthritis: a posthoc analysis of the PREMIER study. J Rheumatol. 2014 Feb;41(2):235-43. doi: 10.3899/jrheum.121468. Epub 2013 Dec 1.

title: Clinical, Functional, and Radiographic Implications of Time to Treatment Response in Patients With Early Rheumatoid Arthritis: a Posthoc Analysis of the PREMIER Study

ReferenceCitation: Keystone EC, Breedveld FC, van der Heijde D, Landewé R, Florentinus S, Arulmani U, Liu S, Kupper H, Kavanaugh A. Longterm effect of delaying combination therapy with tumor necrosis factor inhibitor in patients with aggressive early rheumatoid arthritis: 10-year efficacy and safety of adalimumab from the randomized controlled PREMIER trial with open-label extension. J Rheumatol. 2014 Jan;41(1):5-14. doi: 10.3899/jrheum.130543. Epub 2013 Nov 15.

title: Longterm Effect of Delaying Combination Therapy with Tumor Necrosis Factor Inhibitor in Patients with Aggressive Early Rheumatoid Arthritis: 10-year Efficacy and Safety of Adalimumab from the Randomized Controlled PREMIER Trial with Open-label Extension

ReferenceCitation: Smolen JS, van der Heijde DM, Keystone EC, van Vollenhoven RF, Goldring MB, Guérette B, Cifaldi MA, Chen N, Liu S, Landewé RB. Association of joint space narrowing with impairment of physical function and work ability in patients with early rheumatoid arthritis: protection beyond disease control by adalimumab plus methotrexate. Ann Rheum Dis. 2013 Jul;72(7):1156-62. doi: 10.1136/annrheumdis-2012-201620. Epub 2012 Aug 22. Erratum in: Ann Rheum Dis. 2013 Aug;72(8):1432.

ReferenceCitation: Strand V, Rentz AM, Cifaldi MA, Chen N, Roy S, Revicki D. Health-related quality of life outcomes of adalimumab for patients with early rheumatoid arthritis: results from a randomized multicenter study. J Rheumatol. 2012 Jan;39(1):63-72. doi: 10.3899/jrheum.101161. Epub 2011 Nov 1.

title: Health-related Quality of Life Outcomes of Adalimumab for Patients with Early Rheumatoid Arthritis: Results from a Randomized Multicenter Study

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

location_facility:
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title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5mg and 10mg) of Tiotropium Inhalation Solution Delivered by the Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

summary: To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.

ReferenceCitation: Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

family: Singh

full_name: Dave Singh

given: Dave

family: Wedzicha

full_name: Jadwiga A. Wedzicha

given: Jadwiga A.

family: Siddiqui

full_name: Salman Siddiqui

given: Salman

family: de la Hoz

full_name: Alberto de la Hoz

given: Alberto

family: Xue

full_name: Wenqiong Xue

given: Wenqiong

family: Magnussen

full_name: Helgo Magnussen

given: Helgo

family: Miravitlles

full_name: Marc Miravitlles

given: Marc

family: Chalmers

full_name: James D. Chalmers

given: James D.

family: Calverley

full_name: Peter M. A. Calverley

given: Peter M. A.

journal_name: Respiratory Research

repository_institution: University of Dundee - Discovery Research Portal

ReferenceCitation: Hohlfeld JM, Furtwaengler A, Könen-Bergmann M, Wallenstein G, Walter B, Bateman ED. Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter-ECG data from four randomised clinical trials. Int J Clin Pract. 2015 Jan;69(1):72-80. doi: 10.1111/ijcp.12596. Epub 2014 Dec 11.

name: Fraunhofer Institute for Toxicology and Experimental Medicine Hannover Germany

family: Hohlfeld

full_name: J. M. Hohlfeld

given: J. M.

name: Boehringer Ingelheim Pharma GmbH & Co. K.G. Ingelheim Germany

family: Furtwaengler

full_name: A. Furtwaengler

given: A.

family: Könen‐Bergmann

full_name: M. Könen‐Bergmann

given: M.

family: Wallenstein

full_name: G. Wallenstein

given: G.

name: Independent Consultant Limburgerhof Germany

family: Walter

full_name: B. Walter

given: B.

name: Division of Pulmonology Department of Medicine University of Cape Town Cape Town South Africa

family: Bateman

full_name: E. D. Bateman

given: E. D.

journal_name: International Journal of Clinical Practice

title: Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter‐ECG data from four randomised clinical trials

ReferenceCitation: Hodder R, Pavia D, Lee A, Bateman E. Lack of paradoxical bronchoconstriction after administration of tiotropium via Respimat® Soft Mist™ Inhaler in COPD. Int J Chron Obstruct Pulmon Dis. 2011;6:245-51. doi: 10.2147/COPD.S16094. Epub 2011 Apr 26.

journal_name: International Journal of Chronic Obstructive Pulmonary Disease

location_country:
Italy
Austria
United States
South Africa
Netherlands
Finland
France
Greece
Ireland
Australia
Russian Federation
New Zealand
Spain
Canada
United Kingdom

location_facility: Baumgartner Hohe Otto Wagner Spital Wien

location_facility: Boehringer Ingelheim Investigational Site


title: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Glyburide Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone

summary: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Glyburide Therapy in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone.

ReferenceCitation: Rubin CJ, De Pril V, Fiedorek FT. Coadministration of muraglitazar plus glyburide: improvement of glycaemic and lipid profiles in patients with type 2 diabetes. Diab Vasc Dis Res. 2009 Apr;6(2):120-32. doi: 10.1177/1479164109336049.

name: Pharmaceutical Research Institute, Bristol-Myers Squibb, Princeton, New Jersey, USA,

family: Rubin

full_name: Cindy J. Rubin

given: Cindy J.

name: Bristol-Myers Squibb, Braine-l'Alleud, Belgium

family: De Pril

full_name: Veerle De Pril

given: Veerle

family: Fiedorek

full_name: Fred T. Fiedorek

given: Fred T.

title: Coadministration of muraglitazar plus glyburide: Improvement of glycaemic and lipid profiles in patients with type 2 diabetes

location_country:
Italy
Brazil
United States
Peru
Mexico
Netherlands
Germany
Spain
France
Argentina
Australia
Puerto Rico
Russian Federation
Canada
United Kingdom


title: A Multi-center, Three-staged With Interim Analyses, Parallel, Randomized, Double-blind, fenofibrate-and Placebo-controlled Proof of Concept and Dose-response Evaluation of the Safety, Tolerability, and Effects on Plasma High-density Lipoprotein Cholesterol (HDLc) and Triglycerides of Eight Weeks Treatment With GW501516 in Otherwise Healthy Patients With Low HDLc, Mildly to Moderately Elevated Triglycerides, and Normal Low-density Lipoprotein Cholesterol (LDLc)

summary: The purpose of this clinical research study is to compare up to 3 doses of an investigational drug GW501516 to placebo (an inactive pill that looks like GW501516) to see if it is safe, well tolerated and effective in improving (raising) low levels of "good cholesterol", high-density lipoprotein cholesterol (HDLc), as compared to placebo.

lead_sponsor: GlaxoSmithKline

location_country: Sweden Netherlands Finland France Lithuania Norway Belgium Portugal Estonia Denmark Germany


type: EudraCT Number

title: Recombinant Antihemophilic Factor Manufactured and Formulated Without Added Human or Animal Proteins (rAHF-PFM): Evaluation of Immunogenicity, Efficacy, and Safety in Previously Untreated Patients With Hemophilia A

summary: The purpose of this study is to evaluate whether Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) is effective and safe in the treatment of hemophilia A patients who have not been treated with factor VIII (FVIII) before.

study_start_date_type: Actual

ReferenceType: result

ReferenceCitation: Ewenstein B., Patrone L, Schroth P, Spotts G, Fritsch S, Pavlova B, Ehrlich H. Efficacy of antihemophilic factor (recombinant), plasma/albumin-free method (rAHF-PFM) in bleed prevention. J Thromb Haemost. 2007; 5(Suppl 2): P-S-179.

ReferenceCitation: Ewenstein B., Patrone L, Schroth P, Spotts G, Fritsch S, Pavlova B, Ehrlich H. Efficacy of antihemophilic factor (recombinant), plasma/albumin-free method (rAHF-PFM) in bleed treatment. J Thromb Haemost. 2007; 5(Suppl 2)v: P-S-180.

ReferenceCitation: Shapiro A, Gruppo R, Pabinger I, Collins PW, Hay CR, Schroth P, Casey K, Patrone L, Ehrlich H, Ewenstein BM. Integrated analysis of safety and efficacy of a plasma- and albumin-free recombinant factor VIII (rAHF-PFM) from six clinical studies in patients with hemophilia A. Expert Opin Biol Ther. 2009 Mar;9(3):273-83. doi: 10.1517/14712590902729392 .

family: Shapiro

full_name: Amy Shapiro

given: Amy

family: Gruppo

full_name: Ralph Gruppo

given: Ralph

family: Pabinger

full_name: Ingrid Pabinger

given: Ingrid

family: Collins

full_name: Peter W Collins

given: Peter W

family: Hay

full_name: Charles RM Hay

given: Charles RM

family: Schroth

full_name: Phillip Schroth

given: Phillip

family: Casey

full_name: Kathleen Casey

given: Kathleen

family: Patrone

full_name: Lisa Patrone

given: Lisa

family: Ehrlich

full_name: Hartmut Ehrlich

given: Hartmut

family: Ewenstein

full_name: Bruce M Ewenstein

given: Bruce M

journal_name: Expert Opinion on Biological Therapy

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Auerswald G, Thompson AA, Recht M, Brown D, Liesner R, Guzmán-Becerra N, Dyck-Jones J, Ewenstein B, Abbuehl B. Experience of Advate rAHF-PFM in previously untreated patients and minimally treated patients with haemophilia A. Thromb Haemost. 2012 Jun;107(6):1072-82. doi: 10.1160/TH11-09-0642. Epub 2012 Apr 4.

family: Auerswald

full_name: Guenter Auerswald

given: Guenter

family: Thompson

full_name: Alexis Thompson

given: Alexis

family: Recht

full_name: Michael Recht

given: Michael

family: Brown

full_name: Deborah Brown

given: Deborah

family: Liesner

full_name: Raina Liesner

given: Raina

family: Guzmán-Becerra

full_name: Norma Guzmán-Becerra

given: Norma

family: Dyck-Jones

full_name: Jacqueline Dyck-Jones

given: Jacqueline

full_name: Bruce Ewenstein

given: Bruce

family: Abbuehl

full_name: Brigitt Abbuehl

given: Brigitt

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Italy
Austria
Sweden
Germany
France
Puerto Rico
Spain
United States
United Kingdom
Canada


title: Corticosteroid Therapy of Septic Shock - Corticus. A Multi-National, Prospective, Double-Blind, Randomized, Placebo-Controlled Study

acronym: Corticus

summary: The purpose of the study is to determine whether steroids decrease 28-day mortality in patients with septic shock.

ReferenceType: background

ReferenceCitation: Annane D, Briegel J, Sprung CL. Corticosteroid insufficiency in acutely ill patients. N Engl J Med. 2003 May 22;348(21):2157-9.

ReferenceCitation: Sprung CL, Annane D, Keh D, Moreno R, Singer M, Freivogel K, Weiss YG, Benbenishty J, Kalenka A, Forst H, Laterre PF, Reinhart K, Cuthbertson BH, Payen D, Briegel J; CORTICUS Study Group. Hydrocortisone therapy for patients with septic shock. N Engl J Med. 2008 Jan 10;358(2):111-24. doi: 10.1056/NEJMoa071366.

family: Sprung

full_name: Charles L. Sprung

given: Charles L.

family: Annane

full_name: Djillali Annane

given: Djillali

family: Keh

full_name: Didier Keh

given: Didier

family: Moreno

full_name: Rui Moreno

given: Rui

family: Singer

full_name: Mervyn Singer

given: Mervyn

family: Freivogel

full_name: Klaus Freivogel

given: Klaus

family: Weiss

full_name: Yoram G. Weiss

given: Yoram G.

family: Benbenishty

full_name: Julie Benbenishty

given: Julie

family: Kalenka

full_name: Armin Kalenka

given: Armin

family: Forst

full_name: Helmuth Forst

given: Helmuth

family: Laterre

full_name: Pierre-Francois Laterre

given: Pierre-Francois

family: Reinhart

full_name: Konrad Reinhart

given: Konrad

family: Cuthbertson

full_name: Brian H. Cuthbertson

given: Brian H.

family: Payen

full_name: Didier Payen

family: Briegel

full_name: Josef Briegel

given: Josef

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Hydrocortisone Therapy for Patients with Septic Shock

ReferenceCitation: Polito A, Sonneville R, Guidoux C, Barrett L, Viltart O, Mattot V, Siami S, Lorin de la Grandmaison G, Chrétien F, Singer M, Gray F, Annane D, Brouland JP, Sharshar T. Changes in CRH and ACTH synthesis during experimental and human septic shock. PLoS One. 2011;6(11):e25905. doi: 10.1371/journal.pone.0025905. Epub 2011 Nov 3.

family: Polito

full_name: Andrea Polito

given: Andrea

family: Sonneville

full_name: Romain Sonneville

given: Romain

family: Guidoux

full_name: Céline Guidoux

given: Céline

family: Barrett

full_name: Lucinda Barrett

given: Lucinda

family: Viltart

full_name: Odile Viltart

given: Odile

family: Mattot

repository_institution: University College London - UCL Discovery

repositories:
PubMed Central
UCL Discovery
pdfs.semanticscholar.org

title: Changes in CRH and ACTH Synthesis during Experimental and Human Septic Shock

location_country:
Italy
Austria
Netherlands
France
Israel
Belgium
Portugal
Germany
United Kingdom

location_facility: Institute for Anaesthesia and Operative Intensive Care

location_facility: Krankenhaus der Barmherzigen Schwestern Ges. mbH

location_facility: Centro di Rianimazione Ospedale S.Eugenio

location_facility: Klinikum Mannheim, University of Heidelberg

location_facility: Universitaetsklinik fuer Innere Medizin II

location_facility: Bloomsbury Institute of Intensive Care Medicine


type: Other Identifier

summary:
The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that tracks the outcomes of patients with MPS I. The data collected by the MPS I Registry will provide information to better characterize the natural history and progression of MPS I as well as the clinical responses of patients receiving enzyme replacement therapy, such as Aldurazyme (Recombinant Human Alpha-L-Iduronidase), or other treatment modalities.

The objectives of the Registry are:

To evaluate the long-term effectiveness and safety of Aldurazyme® (laronidase)
To characterize and describe the MPS I population as a whole, including the variability, progression, and natural history of MPS I
To help the MPS I medical community with the development of recommendations for monitoring patients and reports on patient outcomes to optimize patient care

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

enrollment_type: Anticipated

ReferenceCitation: Viskochil D, Muenzer J, Guffon N, Garin C, Munoz-Rojas MV, Moy KA, Hutchinson DT. Carpal tunnel syndrome in mucopolysaccharidosis I: a registry-based cohort study. Dev Med Child Neurol. 2017 Dec;59(12):1269-1275. doi: 10.1111/dmcn.13545. Epub 2017 Sep 11.

ReferenceCitation: Arn P, Bruce IA, Wraith JE, Travers H, Fallet S. Airway-related symptoms and surgeries in patients with mucopolysaccharidosis I. Ann Otol Rhinol Laryngol. 2015 Mar;124(3):198-205. doi: 10.1177/0003489414550154. Epub 2014 Sep 11.

ReferenceCitation: Beck M, Arn P, Giugliani R, Muenzer J, Okuyama T, Taylor J, Fallet S. The natural history of MPS I: global perspectives from the MPS I Registry. Genet Med. 2014 Oct;16(10):759-65. doi: 10.1038/gim.2014.25. Epub 2014 Mar 27.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Malaysia
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
India
France
Japan
Poland
Slovakia
Kuwait
Thailand
Argentina
Indonesia
Canada
Korea, Republic of
Colombia
Chile
Sweden
United Arab Emirates
Saudi Arabia
Hong Kong
Netherlands
Philippines
Vietnam
Singapore
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Czechia
Egypt

location_facility:
Investigational Site Number 818001
Investigational Site Number 250005
Investigational Site Number 840053
Investigational Site Number 840016
Investigational Site Number 153020
Investigational Site Number 153228
Investigational Site Number 840100
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Investigational Site Number 152001
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Investigational Site Number 344001
Investigational Site Number 124021
Investigational Site Number 124001
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investigational site number TBC
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Investigational Site Number 154240
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Investigational Site Number 380001
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Investigational Site Number 356001
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status_simplified: Ongoing


title: Pregabalin Open-Label, Multicenter Add-On Trial Following a 4-Day Double-Blind Transition Period to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.

summary: To evaluate long-term safety and efficacy of pregabalin in patients with partial seizures.

design_allocation: Non-Randomized

lead_sponsor: Pfizer

location_country:
Italy
Austria
South Africa
Sweden
Switzerland
Netherlands
Finland
France
Australia
Belgium
Spain
Germany
United Kingdom


title: A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing a Reyataz-Based Substitution Approach in the Management of Lipodystrophy Syndrome. Research Into Atazanavir in Lipodystrophy (The REAL Study)

summary: The purpose of this clinical research study is to learn if human immunodeficiency virus (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral treatment (HAART) regimen have better changes in fat distribution after switching to atazanavir-ritonavir than those remaining on their current protease inhibitor boosted HAART regimen.

location_country:
Italy
United States
Mexico
France
Poland
Spain
Germany
United Kingdom
Canada


title: An Open-Label, Randomized, Phase 3 Trial Of Intravenous Temsirolimus (CCI-779) At Two Dose Levels Compared To Investigator's Choice Therapy In Relapsed, Refractory Subjects With Mantle Cell Lymphoma (MCL)

acronym: OPTIMAL

summary: This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).

ReferenceCitation: Hess G, Coiffier B, Crump M, Gisselbrecht C, Offner F, Romaguera J, Kang L, Moran PJ. Effect of prognostic classification on temsirolimus efficacy and safety in patients with relapsed or refractory mantle cell lymphoma: a retrospective analysis. Exp Hematol Oncol. 2015 Apr 11;4:11. doi: 10.1186/s40164-015-0006-1. eCollection 2015.

family: Hess

full_name: Georg Hess

given: Georg

family: Coiffier

full_name: Bertrand Coiffier

given: Bertrand

family: Crump

full_name: Michael Crump

given: Michael

family: Gisselbrecht

full_name: Christian Gisselbrecht

given: Christian

family: Offner

full_name: Fritz Offner

given: Fritz

family: Romaguera

full_name: Jorge Romaguera

given: Jorge

family: Kang

full_name: Lisa Kang

given: Lisa

family: Moran

full_name: Pádraig J Moran

given: Pádraig J

journal_name: Experimental Hematology & Oncology

repository_institution: University of Toronto - TSpace

repository_normalized: localhost

repositories:
PubMed Central
localhost

repositories_institution:
PubMed Central - Europe PMC
University of Toronto - TSpace

location_country:
Italy
Austria
Brazil
Chile
Sweden
Switzerland
Netherlands
Spain
Germany
France
Poland
Argentina
Australia
Belgium
China
United States
United Kingdom
Canada


title: A Randomized, Controlled, Open-label Trial to Compare the Efficacy, Safety and Tolerability of TMC114/RTV Versus LPV/RTV in Treatment-Experienced HIV-1 Infected Patients

summary: Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in lopinavir-naïve treatment-experienced HIV-1 infected patients.

ReferenceCitation: Madruga JV, Berger D, McMurchie M, Suter F, Banhegyi D, Ruxrungtham K, Norris D, Lefebvre E, de Béthune MP, Tomaka F, De Pauw M, Vangeneugden T, Spinosa-Guzman S; TITAN study group. Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial. Lancet. 2007 Jul 7;370(9581):49-58.

ReferenceCitation: Bánhegyi D, Katlama C, da Cunha CA, Schneider S, Rachlis A, Workman C, De Meyer S, Vandevoorde A, Van De Casteele T, Tomaka F. Week 96 efficacy, virology and safety of darunavir/r versus lopinavir/r in treatment-experienced patients in TITAN. Curr HIV Res. 2012 Mar;10(2):171-81.

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Guatemala
Malaysia
Greece
Australia
Belgium
Russian Federation
Denmark
France
Panama
Thailand
Argentina
Canada
South Africa
Chile
Switzerland
Netherlands
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Austria
Brazil
Mexico
Spain


title: A Phase II Study to Evaluate the Efficacy, Safety and Pharmacodynamics of Lapatinib in Patients With Relapsed or Refractory Inflammatory Breast Cancer

summary: This study was designed to determine how effective and safe a new investigational drug, lapatinib, is in treating patients with treatment refractory or relapsed inflammatory breast cancer. Tumor tissue collected pre-treatment and at Day 28 will be examined for biologic activity by IHC (immunohistochemistry). Treatment will consist of daily oral therapy with lapatinib. A patient may continue treatment as long as they are receiving benefit. Blood samples for hematology and chemistry panels, MUGA/ECHO (multigated acquisition/echocardiogram) exams and physical exams will be performed throughout the study to monitor safety.

ReferenceCitation: Kaufman B, Trudeau M, Awada A, Blackwell K, Bachelot T, Salazar V, DeSilvio M, Westlund R, Zaks T, Spector N, Johnston S. Lapatinib monotherapy in patients with HER2-overexpressing relapsed or refractory inflammatory breast cancer: final results and survival of the expanded HER2+ cohort in EGF103009, a phase II study. Lancet Oncol. 2009 Jun;10(6):581-8. doi: 10.1016/S1470-2045(09)70087-7. Epub 2009 Apr 24.

family: Kaufman

full_name: Bella Kaufman

given: Bella

family: Trudeau

full_name: Maureen Trudeau

given: Maureen

family: Awada

full_name: Ahmad Awada

given: Ahmad

family: Blackwell

full_name: Kimberly Blackwell

given: Kimberly

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Salazar

full_name: Vanessa Salazar

given: Vanessa

family: DeSilvio

full_name: Michelle DeSilvio

given: Michelle

family: Westlund

full_name: Ronald Westlund

given: Ronald

family: Zaks

full_name: Tal Zaks

given: Tal

family: Spector

full_name: Neil Spector

given: Neil

family: Johnston

full_name: Stephen Johnston

given: Stephen

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Kaufman B, Wu Y, Amonkar MM, Sherrill B, Bachelot T, Salazar V, Viens P, Johnston S. Impact of lapatinib monotherapy on QOL and pain symptoms in patients with HER2+ relapsed or refractory inflammatory breast cancer. Curr Med Res Opin. 2010 May;26(5):1065-73. doi: 10.1185/03007991003680323.

name: The Chaim Sheba Medical Center, Tel Hashomer, Israel

full_name: B. Kaufman

given: B.

name: RTI Health Solutions, Research Triangle Park, NC, USA

family: Wu

full_name: Y. Wu

given: Y.

family: Amonkar

full_name: M.M. Amonkar

family: Sherrill

full_name: B. Sherrill

full_name: T. Bachelot

given: T.

full_name: V. Salazar

given: V.

name: Institut Paoli Calmettes, Marseille, France

family: Viens

full_name: P. Viens

given: P.

full_name: S. Johnston

given: S.

journal_name: Current Medical Research and Opinion

location_country:
United States
France
Israel
Tunisia
Belgium
Spain
Canada
United Kingdom


title: A Randomized, Open-Label, Comparative Evaluation of Conversion From Calcineurin Inhibitor Treatment to Sirolimus Treatment Versus Continued Calcineurin Inhibitor Treatment in Liver Allograft Recipients Undergoing Maintenance Therapy

summary: The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.

status: Terminated

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Italy
United States
Switzerland
Netherlands
Spain
Germany
United Kingdom
France
Belgium
Portugal
Canada
Czech Republic

status_simplified: Unknown


title: A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma

summary: The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).

ReferenceCitation: Rini BI, Hutson TE, Figlin RA, Lechuga MJ, Valota O, Serfass L, Rosbrook B, Motzer RJ. Sunitinib in Patients With Metastatic Renal Cell Carcinoma: Clinical Outcome According to International Metastatic Renal Cell Carcinoma Database Consortium Risk Group. Clin Genitourin Cancer. 2018 Aug;16(4):298-304. doi: 10.1016/j.clgc.2018.04.005. Epub 2018 May 4.

family: Rini

full_name: Brian I. Rini

given: Brian I.

family: Hutson

full_name: Thomas E. Hutson

given: Thomas E.

family: Figlin

full_name: Robert A. Figlin

given: Robert A.

family: Lechuga

full_name: Maria Josè Lechuga

given: Maria Josè

family: Valota

full_name: Olga Valota

given: Olga

family: Serfass

full_name: Lucile Serfass

given: Lucile

family: Rosbrook

full_name: Brad Rosbrook

given: Brad

family: Motzer

full_name: Robert J. Motzer

given: Robert J.

journal_name: Clinical Genitourinary Cancer

oa_host_type: repository

version: acceptedVersion

ReferenceCitation: de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

family: de Velasco

full_name: Guillermo de Velasco

given: Guillermo

family: McKay

full_name: Rana R. McKay

given: Rana R.

family: Lin

full_name: Xun Lin

given: Xun

family: Moreira

full_name: Raphel B. Moreira

given: Raphel B.

family: Simantov

full_name: Ronit Simantov

given: Ronit

family: Choueiri

full_name: Toni K. Choueiri

given: Toni K.

title: Comprehensive Analysis of Survival Outcomes in Non–Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials

ReferenceCitation: Grünwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

family: Grünwald

full_name: Viktor Grünwald

given: Viktor

ReferenceCitation: Grünwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.

title: Depth of Remission is a Prognostic Factor for Survival in Patients with Metastatic Renal Cell Carcinoma

ReferenceCitation: Cella D, Michaelson MD, Bushmakin AG, Cappelleri JC, Charbonneau C, Kim ST, Li JZ, Motzer RJ. Health-related quality of life in patients with metastatic renal cell carcinoma treated with sunitinib vs interferon-alpha in a phase III trial: final results and geographical analysis. Br J Cancer. 2010 Feb 16;102(4):658-64. doi: 10.1038/sj.bjc.6605552. Epub 2010 Jan 26.

title: Health-related quality of life in patients with metastatic renal cell carcinoma treated with sunitinib vs interferon-α in a phase III trial: final results and geographical analysis

ReferenceCitation: Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115-24.

location_country:
Italy
Brazil
United States
Germany
France
Poland
Australia
Russian Federation
Spain
Canada
United Kingdom


title: A Randomized, Controlled, Open-label, Multi-center, Parallel-group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Intravenously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis.

summary: This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

ReferenceCitation: Canaud B, Mingardi G, Braun J, Aljama P, Kerr PG, Locatelli F, Villa G, Van Vlem B, McMahon AW, Kerloëguen C, Beyer U; STRIATA Study Investigators. Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Nephrol Dial Transplant. 2008 Nov;23(11):3654-61. doi: 10.1093/ndt/gfn320. Epub 2008 Jun 27.

family: Canaud

full_name: B. Canaud

given: B.

family: Mingardi

full_name: G. Mingardi

given: G.

family: Braun

full_name: J. Braun

given: J.

family: Aljama

full_name: P. Aljama

given: P.

family: Kerr

full_name: P. G. Kerr

given: P. G.

family: Locatelli

full_name: F. Locatelli

given: F.

family: Villa

full_name: G. Villa

family: Van Vlem

full_name: B. Van Vlem

family: McMahon

full_name: A. W. McMahon

given: A. W.

family: Kerloeguen

full_name: C. Kerloeguen

given: C.

family: Beyer

full_name: U. Beyer

given: U.

name: on behalf of the STRIATA Study Investigators

journal_name: Nephrology Dialysis Transplantation

evidence: open (via crossref license)

license_normalized: cc-by-nc

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Hoffmann-La Roche

location_country: Italy Austria Sweden Switzerland Germany Finland France Australia Belgium Spain Denmark Canada


title: Multiple-dose, Open-label, Randomized, Safety and Pharmacokinetic Study of Tipranavir in Combination With Low-dose Ritonavir in HIV-infected Pediatric Patients

summary:
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide information concerning the pharmacokinetic characteristics of tipranavir and ritonavir in this age group, and to determine the relative bioavailability of the TPV liquid formulation and TPV capsule formulation in adolescents switching from liquid to capsule.

The secondary objective of this study is the determination of the dose of topranavir and ritonavir (TPV/r) in children and adolescents between 2 and 18 years of age required for an adult equivalent systemic exposure of TPV/r 500 mg / 200 mg.

ReferenceCitation: Salazar JC, Cahn P, Della Negra M, De Aquino MZ, Robinson PA, Jelaska A, Mikl J. Efficacy and safety of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents: 5 years of experience. Pediatr Infect Dis J. 2014 Apr;33(4):396-400. doi: 10.1097/INF.0000000000000038.

family: Salazar

full_name: Juan C. Salazar

given: Juan C.

family: Cahn

full_name: Pedro Cahn

given: Pedro

family: Della Negra

full_name: Marinella Della Negra

given: Marinella

family: De Aquino

full_name: Maria Zilda De Aquino

given: Maria Zilda

family: Robinson

full_name: Patrick A. Robinson

given: Patrick A.

family: Jelaska

full_name: Ante Jelaska

given: Ante

family: Mikl

full_name: Jaromir Mikl

given: Jaromir

journal_name: Pediatric Infectious Disease Journal

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Efficacy and Safety of Tipranavir Coadministered with Ritonavir in HIV-1-Infected Children and Adolescents

ReferenceCitation: Salazar JC, Cahn P, Yogev R, Negra MD, Castelli-Gattinara G, Fortuny C, Flynn PM, Giaquinto C, Ruan PK, Smith ME, Mikl J, Jelaska A; PACTG 1051/BI Study Team. Efficacy, safety and tolerability of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents. AIDS. 2008 Sep 12;22(14):1789-98. doi: 10.1097/QAD.0b013e32830c481b.

full_name: Juan C Salazar

given: Juan C

family: Yogev

full_name: Ram Yogev

given: Ram

family: Negra

given: Marinella Della

family: Castelli-Gattinara

full_name: Guido Castelli-Gattinara

given: Guido

family: Fortuny

full_name: Claudia Fortuny

given: Claudia

family: Flynn

full_name: Patrica M Flynn

given: Patrica M

family: Giaquinto

full_name: Carlo Giaquinto

given: Carlo

family: Ruan

full_name: Ping K Ruan

given: Ping K

family: Smith

full_name: M Elizabeth Smith

given: M Elizabeth

journal_name: AIDS

location_country:
Italy
Brazil
United States
Mexico
Germany
France
Argentina
Puerto Rico
Spain
Canada

location_facility: 1182.14.00003 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.33002 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.34002 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.49001 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00010 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00009 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00001 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00008 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.33003 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00005 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.49004 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.52001 CLINDI (Clínica de Inmunodeficiencias)

location_facility: 1182.14.33001 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00004 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.34001 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.33005 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.49002 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.33006 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00007 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.11002 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00002 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00006 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.33004 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.39001 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.39003 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.11001 Boehringer Ingelheim Investigational Site


title: A Randomised, Blinded, Phase 2 Study of Letrozole Plus the Farnesyl Transferase Inhibitor ZARNESTRA TM (R115777) and Letrozole Plus Placebo in the Treatment of Advanced Breast Cancer After Antiestrogen Therapy.

summary: The purpose of this study is to determine if the addition of tipifarnib to standard letrozole therapy leads to a better response to treatment for your cancer in comparison to letrozole plus a placebo. Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make cancer cells grow.

ReferenceCitation: Johnston SR, Semiglazov VF, Manikhas GM, Spaeth D, Romieu G, Dodwell DJ, Wardley AM, Neven P, Bessems A, Park YC, De Porre PM, Perez Ruixo JJ, Howes AJ. A phase II, randomized, blinded study of the farnesyltransferase inhibitor tipifarnib combined with letrozole in the treatment of advanced breast cancer after antiestrogen therapy. Breast Cancer Res Treat. 2008 Jul;110(2):327-35. Epub 2007 Sep 13.

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

location_country:
Netherlands
France
Russian Federation
Belgium
United States
United Kingdom


type: U.S. NIH Grant/Contract

title: Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)

summary: The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).

primary_purpose: Prevention

ReferenceCitation: Whellan DJ, O'Connor CM, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Houston-Miller N, Fleg JL, Schulman KA, Piña IL; HF-ACTION Trial Investigators. Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. Am Heart J. 2007 Feb;153(2):201-11.

ReferenceCitation: Truby LK, Regan JA, Giamberardino SN, Ilkayeva O, Bain J, Newgard CB, O'Connor CM, Felker GM, Kraus WE, McGarrah RW, Shah SH. Circulating long chain acylcarnitines and outcomes in diabetic heart failure: an HF-ACTION clinical trial substudy. Cardiovasc Diabetol. 2021 Aug 3;20(1):161. doi: 10.1186/s12933-021-01353-z.

family: Truby

full_name: Lauren K. Truby

given: Lauren K.

family: Regan

full_name: Jessica A. Regan

given: Jessica A.

family: Giamberardino

full_name: Stephanie N. Giamberardino

given: Stephanie N.

family: Ilkayeva

full_name: Olga Ilkayeva

given: Olga

family: Bain

full_name: James Bain

given: James

family: Newgard

full_name: Christopher B. Newgard

given: Christopher B.

family: O’Connor

full_name: Christopher M. O’Connor

given: Christopher M.

family: Felker

full_name: G. Michael Felker

given: G. Michael

family: Kraus

full_name: William E. Kraus

given: William E.

family: McGarrah

full_name: Robert W. McGarrah

given: Robert W.

family: Shah

full_name: Svati H. Shah

given: Svati H.

journal_name: Cardiovascular Diabetology

title: Circulating long chain acylcarnitines and outcomes in diabetic heart failure: an HF-ACTION clinical trial substudy

ReferenceCitation: Feng KY, O'Connor CM, Clare R, Alhanti B, Piña IL, Kraus WE, Whellan DJ, Mentz RJ. Greater Pain Severity Is Associated with Worse Outcomes in Patients with Heart Failure. J Cardiovasc Transl Res. 2021 Oct;14(5):984-991. doi: 10.1007/s12265-021-10104-0. Epub 2021 Feb 9.

family: Feng

full_name: Kent Y. Feng

given: Kent Y.

family: Clare

full_name: Robert Clare

given: Robert

journal_name: Journal of Cardiovascular Translational Research

title: Greater Pain Severity Is Associated with Worse Outcomes in Patients with Heart Failure

ReferenceCitation: Regan JA, Kitzman DW, Leifer ES, Kraus WE, Fleg JL, Forman DE, Whellan DJ, Wojdyla D, Parikh K, O'Connor CM, Mentz RJ. Impact of Age on Comorbidities and Outcomes in Heart Failure With Reduced Ejection Fraction. JACC Heart Fail. 2019 Dec;7(12):1056-1065. doi: 10.1016/j.jchf.2019.09.004.

title: Impact of Age on Comorbidities and Outcomes in Heart Failure With Reduced Ejection Fraction

ReferenceCitation: Mediano MFF, Leifer ES, Cooper LS, Keteyian SJ, Kraus WE, Mentz RJ, Fleg JL. Influence of Baseline Physical Activity Level on Exercise Training Response and Clinical Outcomes in Heart Failure: The HF-ACTION Trial. JACC Heart Fail. 2018 Dec;6(12):1011-1019. doi: 10.1016/j.jchf.2018.09.012.

title: Influence of Baseline Physical Activity Level on Exercise Training Response and Clinical Outcomes in Heart Failure

ReferenceCitation: Luo N, O'Connor CM, Cooper LB, Sun JL, Coles A, Reed SD, Whellan DJ, Piña IL, Kraus WE, Mentz RJ. Relationship between changing patient-reported outcomes and subsequent clinical events in patients with chronic heart failure: insights from HF-ACTION. Eur J Heart Fail. 2019 Jan;21(1):63-70. doi: 10.1002/ejhf.1299. Epub 2018 Aug 31.

name: Division of Cardiology, Department of Medicine; Duke University Medical Center; Durham NC USA

name: Duke Clinical Research Institute; Durham NC USA

name: Inova Heart and Vascular Institute; Falls Church VA USA

name: Thomas Jefferson University; Philadelphia PA USA

name: Montefiore-Einstein Medical Center; New York NY USA

title: Relationship between changing patient-reported outcomes and subsequent clinical events in patients with chronic heart failure: insights from HF-ACTION

ReferenceCitation: Warraich HJ, O'Connor C, Wu A, Coles A, Kraus WE, Piña IL, Whellan DJ, Mentz RJ. Differences Between Patients Enrolled Early and Late During Clinical Trial Recruitment: Insights From the HF-ACTION Trial. Circ Cardiovasc Qual Outcomes. 2018 Jul;11(7):e004643. doi: 10.1161/CIRCOUTCOMES.117.004643.

name: Duke Clinical Research Institute, Durham, NC (H.J.W., A.W., A.C., R.J.M.).

name: Department of Medicine (Cardiology Division), Duke University Medical Center, Durham, NC (H.J.W., W.E.K., R.J.M.).

name: Inova Heart and Vascular Institute, Fairfax VA (C.O.).

name: Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (I.L.P.).

name: Thomas Jefferson University Hospital, Sidney Kimmel Medical College, Philadelphia, PA (D.J.W.).

journal_name: Circulation: Cardiovascular Quality and Outcomes

title: Differences Between Patients Enrolled Early and Late During Clinical Trial Recruitment

ReferenceCitation: Ambrosy AP, Bhatt AS, Stebbins AL, Wruck LM, Fudim M, Greene SJ, Kraus WE, O'Connor CM, Piña IL, Whellan DJ, Mentz RJ. Prevalent digoxin use and subsequent risk of death or hospitalization in ambulatory heart failure patients with a reduced ejection fraction-Findings from the Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) randomized controlled trial. Am Heart J. 2018 May;199:97-104. doi: 10.1016/j.ahj.2018.02.004. Epub 2018 Feb 11.

title: Prevalent digoxin use and subsequent risk of death or hospitalization in ambulatory heart failure patients with a reduced ejection fraction—Findings from the Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) randomized controlled trial

ReferenceCitation: Pokharel Y, Khariton Y, Tang Y, Nassif ME, Chan PS, Arnold SV, Jones PG, Spertus JA. Association of Serial Kansas City Cardiomyopathy Questionnaire Assessments With Death and Hospitalization in Patients With Heart Failure With Preserved and Reduced Ejection Fraction: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Cardiol. 2017 Dec 1;2(12):1315-1321. doi: 10.1001/jamacardio.2017.3983. Erratum in: JAMA Cardiol. 2018 Feb 1;3(2):181.

name: Saint Luke’s Mid America Heart Institute, Kansas City, Missouri

ReferenceCitation: Sharma A, Stevens SR, Lucas J, Fiuzat M, Adams KF, Whellan DJ, Donahue MP, Kitzman DW, Piña IL, Zannad F, Kraus WE, O'Connor CM, Felker GM. Utility of Growth Differentiation Factor-15, A Marker of Oxidative Stress and Inflammation, in Chronic Heart Failure: Insights From the HF-ACTION Study. JACC Heart Fail. 2017 Oct;5(10):724-734. doi: 10.1016/j.jchf.2017.07.013.

title: Utility of Growth Differentiation Factor-15, A Marker of Oxidative Stress and Inflammation, in Chronic Heart Failure

ReferenceCitation: Ambrosy AP, Cerbin LP, DeVore AD, Greene SJ, Kraus WE, O'Connor CM, Piña IL, Whellan DJ, Wojdyla D, Wu A, Mentz RJ. Aerobic exercise training and general health status in ambulatory heart failure patients with a reduced ejection fraction-Findings from the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)trial. Am Heart J. 2017 Apr;186:130-138. doi: 10.1016/j.ahj.2016.12.017. Epub 2017 Jan 19.

title: Aerobic exercise training and general health status in ambulatory heart failure patients with a reduced ejection fraction—Findings from the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)trial

ReferenceCitation: Luo N, Merrill P, Parikh KS, Whellan DJ, Piña IL, Fiuzat M, Kraus WE, Kitzman DW, Keteyian SJ, O'Connor CM, Mentz RJ. Exercise Training in Patients With Chronic Heart Failure and Atrial Fibrillation. J Am Coll Cardiol. 2017 Apr 4;69(13):1683-1691. doi: 10.1016/j.jacc.2017.01.032.

journal_name: Journal of the American College of Cardiology

title: Exercise Training in Patients With Chronic Heart Failure and Atrial Fibrillation

ReferenceCitation: Kelly JP, Dunning A, Schulte PJ, Fiuzat M, Leifer ES, Fleg JL, Cooper LS, Keteyian SJ, Kitzman DW, Pina IL, Kraus WE, Whellan DJ, O'Connor CM, Mentz RJ. Statins and Exercise Training Response in Heart Failure Patients: Insights From HF-ACTION. JACC Heart Fail. 2016 Aug;4(8):617-24. doi: 10.1016/j.jchf.2016.05.006. Epub 2016 Jul 6.

title: Statins and Exercise Training Response in Heart Failure Patients

ReferenceCitation: Keteyian SJ, Patel M, Kraus WE, Brawner CA, McConnell TR, Piña IL, Leifer ES, Fleg JL, Blackburn G, Fonarow GC, Chase PJ, Piner L, Vest M, O'Connor CM, Ehrman JK, Walsh MN, Ewald G, Bensimhon D, Russell SD; HF-ACTION Investigators. Variables Measured During Cardiopulmonary Exercise Testing as Predictors of Mortality in Chronic Systolic Heart Failure. J Am Coll Cardiol. 2016 Feb 23;67(7):780-9. doi: 10.1016/j.jacc.2015.11.050. Erratum in: J Am Coll Cardiol. 2016 Apr 26;67(16):1979-80.

title: Variables Measured During Cardiopulmonary Exercise Testing as Predictors of Mortality in Chronic Systolic Heart Failure

ReferenceCitation: Ahmad T, Kelly JP, McGarrah RW, Hellkamp AS, Fiuzat M, Testani JM, Wang TS, Verma A, Samsky MD, Donahue MP, Ilkayeva OR, Bowles DE, Patel CB, Milano CA, Rogers JG, Felker GM, O'Connor CM, Shah SH, Kraus WE. Prognostic Implications of Long-Chain Acylcarnitines in Heart Failure and Reversibility With Mechanical Circulatory Support. J Am Coll Cardiol. 2016 Jan 26;67(3):291-9. doi: 10.1016/j.jacc.2015.10.079.

title: Prognostic Implications of Long-Chain Acylcarnitines in Heart Failure and Reversibility With Mechanical Circulatory Support

ReferenceCitation: Cooper LB, Mentz RJ, Sun JL, Schulte PJ, Fleg JL, Cooper LS, Piña IL, Leifer ES, Kraus WE, Whellan DJ, Keteyian SJ, O'Connor CM. Psychosocial Factors, Exercise Adherence, and Outcomes in Heart Failure Patients: Insights From Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION). Circ Heart Fail. 2015 Nov;8(6):1044-51. doi: 10.1161/CIRCHEARTFAILURE.115.002327. Erratum in: Circ Heart Fail. 2016 Mar;9(3):e000014.

name: From the Duke Clinical Research Institute (L.B.C., R.J.M., J.-L.S., P.J.S., C.M.O’C.), and Department of Medicine (L.B.C., R.J.M., W.E.K., C.M.O’C.), Duke University School of Medicine, Durham, NC; Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD (J.L.F., L.S.C., E.S.L.); Division of Cardiology, Albert Einstein College of Medicine, Bronx, NY (I.L.P.); Division of Cardiology, Jefferson Medical College, Philadelphia, PA (D.J.W.); and Division of...

title: Psychosocial Factors, Exercise Adherence, and Outcomes in Heart Failure Patients

ReferenceCitation: Fiuzat M, Wojdyla D, Pina I, Adams K, Whellan D, O'Connor CM. Heart Rate or Beta-Blocker Dose? Association With Outcomes in Ambulatory Heart Failure Patients With Systolic Dysfunction: Results From the HF-ACTION Trial. JACC Heart Fail. 2016 Feb;4(2):109-115. doi: 10.1016/j.jchf.2015.09.002. Epub 2015 Oct 28.

title: Heart Rate or Beta-Blocker Dose? Association With Outcomes in Ambulatory Heart Failure Patients With Systolic Dysfunction

ReferenceCitation: Ahmad T, O'Brien EC, Schulte PJ, Stevens SR, Fiuzat M, Kitzman DW, Adams KF, Kraus WE, Piña IL, Donahue MP, Zannad F, Whellan DJ, O'Connor CM, Felker GM. Evaluation of the Incremental Prognostic Utility of Increasingly Complex Testing in Chronic Heart Failure. Circ Heart Fail. 2015 Jul;8(4):709-16. doi: 10.1161/CIRCHEARTFAILURE.114.001996. Epub 2015 Jun 1.

name: From the Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, CT (T.A.); Duke Clinical Research Institute, Durham, NC (E.C.O., P.J.S., S.R.S., M.F., C.M.O., G.M.F.); Division of Cardiology, Duke University Medical Center, Durham, NC (M.F., W.E.K., M.P.D., G.M.F.); Department of Cardiology, Wake Forest University, Winston-Salem, NC (D.W.K.); Department of Cardiology, University of North Carolina, Chapel Hill (K.F.A.); Montefiore Medical Center, Bronx, NY (I.L.P.); Department of...

title: Evaluation of the Incremental Prognostic Utility of Increasingly Complex Testing in Chronic Heart Failure

ReferenceCitation: Dardas T, Li Y, Reed SD, O'Connor CM, Whellan DJ, Ellis SJ, Schulman KA, Kraus WE, Forman DE, Levy WC. Incremental and independent value of cardiopulmonary exercise test measures and the Seattle Heart Failure Model for prediction of risk in patients with heart failure. J Heart Lung Transplant. 2015 Aug;34(8):1017-23. doi: 10.1016/j.healun.2015.03.017. Epub 2015 Mar 26.

journal_name: The Journal of Heart and Lung Transplantation

ReferenceCitation: Mentz RJ, Babyak MA, Bittner V, Fleg JL, Keteyian SJ, Swank AM, Piña IL, Kraus WE, Whellan DJ, O'Connor CM, Blumenthal JA; HF-ACTION Investigators. Prognostic significance of depression in blacks with heart failure: insights from Heart Failure: a Controlled Trial Investigating Outcomes of Exercise Training. Circ Heart Fail. 2015 May;8(3):497-503. doi: 10.1161/CIRCHEARTFAILURE.114.001995. Epub 2015 Apr 21.

name: From the Duke University Medical Center, Durham, NC (R.J.M., M.A.B., W.E.K., C.M.O’C., J.A.B.); University of Alabama at Birmingham (V.B.); National Heart, Lung, and Blood Institute, Bethesda, MD (J.L.F.); Henry Ford Hospital, Detroit, MI (S.J.K.); University of Louisville, KY (A.M.S.); Montefiore-Einstein Medical Center, New York, NY (I.L.P.); and Thomas Jefferson University, Philadelphia, PA (D.J.W.).

title: Prognostic Significance of Depression in Blacks With Heart Failure

ReferenceCitation: Ahmad T, Pencina MJ, Schulte PJ, O'Brien E, Whellan DJ, Piña IL, Kitzman DW, Lee KL, O'Connor CM, Felker GM. Clinical implications of chronic heart failure phenotypes defined by cluster analysis. J Am Coll Cardiol. 2014 Oct 28;64(17):1765-74. doi: 10.1016/j.jacc.2014.07.979. Epub 2014 Oct 21.

title: Clinical Implications of Chronic Heart Failure Phenotypes Defined by Cluster Analysis

ReferenceCitation: Jones LW, Douglas PS, Khouri MG, Mackey JR, Wojdyla D, Kraus WE, Whellan DJ, O'Connor CM. Safety and efficacy of aerobic training in patients with cancer who have heart failure: an analysis of the HF-ACTION randomized trial. J Clin Oncol. 2014 Aug 10;32(23):2496-502. doi: 10.1200/JCO.2013.53.5724. Epub 2014 Jul 7.

name: Lee W. Jones, Memorial Sloan Kettering Cancer Center, New York, NY; Pamela S. Douglas, Michel G. Khouri, Daniel Wojdyla, William E. Kraus, and Christopher M. O'Connor, Duke University Medical Center, Durham, NC; John R. Mackey, University of Alberta, Edmonton, Alberta, Canada; and David J. Whellan, Thomas Jefferson University, Philadelphia, PA.

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)

title: Safety and Efficacy of Aerobic Training in Patients With Cancer Who Have Heart Failure: An Analysis of the HF-ACTION Randomized Trial

ReferenceCitation: Felker GM, Fiuzat M, Thompson V, Shaw LK, Neely ML, Adams KF, Whellan DJ, Donahue MP, Ahmad T, Kitzman DW, Piña IL, Zannad F, Kraus WE, O'Connor CM. Soluble ST2 in ambulatory patients with heart failure: Association with functional capacity and long-term outcomes. Circ Heart Fail. 2013 Nov;6(6):1172-9. doi: 10.1161/CIRCHEARTFAILURE.113.000207. Epub 2013 Oct 8.

name: From the Division of Cardiology, Duke University Medical Center, Durham, NC (G.M.F., M.F., M.P.D., T.A., W.E.K., C.M.O); Division of Cardiology, Duke Clinical Research Institute, Durham, NC (V.T., L.K.S., M.L.N.); Division of Cardiology, University of North Carolina, Chapel Hill (K.F.A.); Division of Cardiology, Thomas Jefferson University, Philadelphia, PA (D.J.W.); Division of Cardiology, Wake Forrest University, Winston-Salem, NC (D.W.K.); Division of Cardiology, Montefiore Medical Center, Bronx,...

title: Soluble ST2 in Ambulatory Patients With Heart Failure

ReferenceCitation: Piccini JP, Hellkamp AS, Whellan DJ, Ellis SJ, Keteyian SJ, Kraus WE, Hernandez AF, Daubert JP, Piña lL, O'Connor CM; HF-ACTION Investigators. Exercise training and implantable cardioverter-defibrillator shocks in patients with heart failure: results from HF-ACTION (Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing). JACC Heart Fail. 2013 Apr;1(2):142-8.

ReferenceCitation: McCullough PA, Barnard D, Clare R, Ellis SJ, Fleg JL, Fonarow GC, Franklin BA, Kilpatrick RD, Kitzman DW, O'Connor CM, Piña IL, Thadani U, Thohan V, Whellan DJ; HF-ACTION Investigators. Anemia and associated clinical outcomes in patients with heart failure due to reduced left ventricular systolic function. Clin Cardiol. 2013 Oct;36(10):611-20. doi: 10.1002/clc.22181. Epub 2013 Aug 8.

title: Anemia and Associated Clinical Outcomes in Patients With Heart Failure Due to Reduced Left Ventricular Systolic Function

ReferenceCitation: Li Y, Neilson MP, Whellan DJ, Schulman KA, Levy WC, Reed SD. Associations between Seattle Heart Failure Model scores and health utilities: findings from HF-ACTION. J Card Fail. 2013 May;19(5):311-6. doi: 10.1016/j.cardfail.2013.03.008.

title: Associations Between Seattle Heart Failure Model Scores and Health Utilities: Findings From HF-ACTION

ReferenceCitation: Keteyian SJ, Leifer ES, Houston-Miller N, Kraus WE, Brawner CA, O'Connor CM, Whellan DJ, Cooper LS, Fleg JL, Kitzman DW, Cohen-Solal A, Blumenthal JA, Rendall DS, Piña IL; HF-ACTION Investigators. Relation between volume of exercise and clinical outcomes in patients with heart failure. J Am Coll Cardiol. 2012 Nov 6;60(19):1899-905. doi: 10.1016/j.jacc.2012.08.958. Epub 2012 Oct 10.

title: Relation Between Volume of Exercise and Clinical Outcomes in Patients With Heart Failure

ReferenceCitation: Reed SD, Li Y, Ellis SJ, Isitt JJ, Cheng S, Schulman KA, Whellan DJ. Associations between hemoglobin level, resource use, and medical costs in patients with heart failure: findings from HF-ACTION. J Card Fail. 2012 Oct;18(10):784-91. doi: 10.1016/j.cardfail.2012.08.359.

title: Associations Between Hemoglobin Level, Resource Use, and Medical Costs in Patients With Heart Failure: Findings From HF-ACTION

ReferenceCitation: Blumenthal JA, Babyak MA, O'Connor C, Keteyian S, Landzberg J, Howlett J, Kraus W, Gottlieb S, Blackburn G, Swank A, Whellan DJ. Effects of exercise training on depressive symptoms in patients with chronic heart failure: the HF-ACTION randomized trial. JAMA. 2012 Aug 1;308(5):465-74. doi: 10.1001/jama.2012.8720. Erratum in: JAMA. 2012 Nov 7;308(17):1742.

title: Effects of Exercise Training on Depressive Symptoms in Patients With Chronic Heart Failure

ReferenceCitation: Swank AM, Horton J, Fleg JL, Fonarow GC, Keteyian S, Goldberg L, Wolfel G, Handberg EM, Bensimhon D, Illiou MC, Vest M, Ewald G, Blackburn G, Leifer E, Cooper L, Kraus WE; HF-ACTION Investigators. Modest increase in peak VO2 is related to better clinical outcomes in chronic heart failure patients: results from heart failure and a controlled trial to investigate outcomes of exercise training. Circ Heart Fail. 2012 Sep 1;5(5):579-85. Epub 2012 Jul 6.

ReferenceCitation: Fiuzat M, Wojdyla D, Kitzman D, Fleg J, Keteyian SJ, Kraus WE, Piña IL, Whellan D, O'Connor CM. Relationship of beta-blocker dose with outcomes in ambulatory heart failure patients with systolic dysfunction: results from the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trial. J Am Coll Cardiol. 2012 Jul 17;60(3):208-15. doi: 10.1016/j.jacc.2012.03.023. Epub 2012 May 2.

title: Relationship of Beta-Blocker Dose With Outcomes in Ambulatory Heart Failure Patients With Systolic Dysfunction

ReferenceCitation: Whellan DJ, Nigam A, Arnold M, Starr AZ, Hill J, Fletcher G, Ellis SJ, Cooper L, Onwuanyi A, Chandler B, Keteyian SJ, Ewald G, Kao A, Gheorghiade M. Benefit of exercise therapy for systolic heart failure in relation to disease severity and etiology-findings from the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise Training study. Am Heart J. 2011 Dec;162(6):1003-10. doi: 10.1016/j.ahj.2011.09.017.

title: Benefit of exercise therapy for systolic heart failure in relation to disease severity and etiology—findings from the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise Training study

ReferenceCitation: O'Connor CM, Whellan DJ, Wojdyla D, Leifer E, Clare RM, Ellis SJ, Fine LJ, Fleg JL, Zannad F, Keteyian SJ, Kitzman DW, Kraus WE, Rendall D, Piña IL, Cooper LS, Fiuzat M, Lee KL. Factors related to morbidity and mortality in patients with chronic heart failure with systolic dysfunction: the HF-ACTION predictive risk score model. Circ Heart Fail. 2012 Jan;5(1):63-71. doi: 10.1161/CIRCHEARTFAILURE.111.963462. Epub 2011 Nov 23.

name: From the Duke Clinical Research Institute, Durham, NC (C.M.O., D.W., R.M.C., S.J.E., M.F., D.R., K.L.L.); Thomas Jefferson University, Philadelphia, PA (D.J.W.); National Heart, Lung, and Blood Institute, Bethesda, MD (E.L., L.J.F., J.L.F., L.S.C.); Nancy University, Nancy, France (F.Z.); Henry Ford Hospital, Detroit, MI (S.J.K.); Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, NC (D.W.K.); Departments of Psychiatry and Behavioral Science and Medicine, Duke...

title: Factors Related to Morbidity and Mortality in Patients With Chronic Heart Failure With Systolic Dysfunction

ReferenceCitation: Felker GM, Fiuzat M, Shaw LK, Clare R, Whellan DJ, Bettari L, Shirolkar SC, Donahue M, Kitzman DW, Zannad F, Piña IL, O'Connor CM. Galectin-3 in ambulatory patients with heart failure: results from the HF-ACTION study. Circ Heart Fail. 2012 Jan;5(1):72-8. doi: 10.1161/CIRCHEARTFAILURE.111.963637. Epub 2011 Oct 20.

name: From Duke University Medical Center, Durham, NC (G.M.F., M.F., L.K.S., R.C., S.C.S., M.D., C.M.O.); Thomas Jefferson University, Philadelphia, PA (D.J.W.); University of Brescia, Brescia, Italy (L.B.); Wake Forest University, Winston-Salem, NC (D.W.K.); Nancy University, Nancy, France (F.Z.); and Case Western Reserve University, Cleveland, OH (I.L.P.).

title: Galectin-3 in Ambulatory Patients With Heart Failure

ReferenceCitation: Atchley AE, Iskandrian AE, Bensimhon D, Ellis SJ, Kitzman DW, Shaw LK, Pagnanelli RA, Whellan DJ, Gardin JM, Kao A, Abdul-Nour K, Ewald G, Walsh MN, Kraus WE, O'Connor CM, Borges-Neto S; HF-ACTION Trial Nuclear Ancillary Study Investigators. Relationship of technetium-99m tetrofosmin-gated rest single-photon emission computed tomography myocardial perfusion imaging to death and hospitalization in heart failure patients: results from the nuclear ancillary study of the HF-ACTION trial. Am Heart J. 2011 Jun;161(6):1038-45. doi: 10.1016/j.ahj.2011.02.007. Epub 2011 Apr 6.

ReferenceCitation: Reed SD, Whellan DJ, Li Y, Friedman JY, Ellis SJ, Piña IL, Settles SJ, Davidson-Ray L, Johnson JL, Cooper LS, O'Connor CM, Schulman KA; HF-ACTION Investigators. Economic evaluation of the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) randomized controlled trial: an exercise training study of patients with chronic heart failure. Circ Cardiovasc Qual Outcomes. 2010 Jul;3(4):374-81. doi: 10.1161/CIRCOUTCOMES.109.907287. Epub 2010 Jun 15.

name: From the Duke Clinical Research Institute (S.D.R., D.J.W., Y.L., J.Y.F., S.J.E., S.J.S., L.D.-R., C.M.O., K.A.S.) and Department of Medicine (S.D.R., D.J.W., J.L.J., C.M.O., K.A.S.), Duke University School of Medicine, Durham, NC; the Department of Medicine, Jefferson Medical College, Thomas Jefferson University, Philadelphia, Pa (D.J.W.); the Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio (I.L.P.); and the Division of Cardiovascular Sciences, National...

title: Economic Evaluation of the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) Randomized Controlled Trial

ReferenceCitation: Keteyian SJ, Isaac D, Thadani U, Roy BA, Bensimhon DR, McKelvie R, Russell SD, Hellkamp AS, Kraus WE; HF-ACTION Investigators. Safety of symptom-limited cardiopulmonary exercise testing in patients with chronic heart failure due to severe left ventricular systolic dysfunction. Am Heart J. 2009 Oct;158(4 Suppl):S72-7. doi: 10.1016/j.ahj.2009.07.014.

title: Safety of symptom-limited cardiopulmonary exercise testing in patients with chronic heart failure due to severe left ventricular systolic dysfunction

ReferenceCitation: Flynn KE, Lin L, Ellis SJ, Russell SD, Spertus JA, Whellan DJ, Piña IL, Fine LJ, Schulman KA, Weinfurt KP; HF-ACTION Investigators. Outcomes, health policy, and managed care: relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure. Am Heart J. 2009 Oct;158(4 Suppl):S64-71. doi: 10.1016/j.ahj.2009.07.010.

title: Outcomes, health policy, and managed care: Relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure

ReferenceCitation: Atchley AE, Kitzman DW, Whellan DJ, Iskandrian AE, Ellis SJ, Pagnanelli RA, Kao A, Abdul-Nour K, O'Connor CM, Ewald G, Kraus WE, Borges-Neto S; HF-ACTION Investigators. Myocardial perfusion, function, and dyssynchrony in patients with heart failure: baseline results from the single-photon emission computed tomography imaging ancillary study of the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION) Trial. Am Heart J. 2009 Oct;158(4 Suppl):S53-63. doi: 10.1016/j.ahj.2009.07.009.

title: Myocardial perfusion, function, and dyssynchrony in patients with heart failure: Baseline results from the single-photon emission computed tomography imaging ancillary study of the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION) Trial

ReferenceCitation: Felker GM, Whellan D, Kraus WE, Clare R, Zannad F, Donahue M, Adams K, McKelvie R, Piña IL, O'Connor CM; HF-ACTION Investigators. N-terminal pro-brain natriuretic peptide and exercise capacity in chronic heart failure: data from the Heart Failure and a Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) study. Am Heart J. 2009 Oct;158(4 Suppl):S37-44. doi: 10.1016/j.ahj.2009.07.011.

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

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

title: N-terminal pro–brain natriuretic peptide and exercise capacity in chronic heart failure: Data from the Heart Failure and a Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) study

ReferenceCitation: Horwich TB, Leifer ES, Brawner CA, Fitz-Gerald MB, Fonarow GC; HF-ACTION Investigators. The relationship between body mass index and cardiopulmonary exercise testing in chronic systolic heart failure. Am Heart J. 2009 Oct;158(4 Suppl):S31-6. doi: 10.1016/j.ahj.2009.07.016.

title: The relationship between body mass index and cardiopulmonary exercise testing in chronic systolic heart failure

ReferenceCitation: Russell SD, Saval MA, Robbins JL, Ellestad MH, Gottlieb SS, Handberg EM, Zhou Y, Chandler B; HF-ACTION Investigators. New York Heart Association functional class predicts exercise parameters in the current era. Am Heart J. 2009 Oct;158(4 Suppl):S24-30. doi: 10.1016/j.ahj.2009.07.017.

title: New York Heart Association functional class predicts exercise parameters in the current era

ReferenceCitation: Piña IL, Kokkinos P, Kao A, Bittner V, Saval M, Clare B, Goldberg L, Johnson M, Swank A, Ventura H, Moe G, Fitz-Gerald M, Ellis SJ, Vest M, Cooper L, Whellan D; HF-ACTION Investigators. Baseline differences in the HF-ACTION trial by sex. Am Heart J. 2009 Oct;158(4 Suppl):S16-23. doi: 10.1016/j.ahj.2009.07.012.

title: Baseline differences in the HF-ACTION trial by sex

ReferenceCitation: Whellan DJ, Ellis SJ, Kraus WE, Hawthorne K, Piña IL, Keteyian SJ, Kitzman DW, Cooper L, Lee K, O'Connor CM. Method for establishing authorship in a multicenter clinical trial. Ann Intern Med. 2009 Sep 15;151(6):414-20.

ReferenceCitation: Flynn KE, Piña IL, Whellan DJ, Lin L, Blumenthal JA, Ellis SJ, Fine LJ, Howlett JG, Keteyian SJ, Kitzman DW, Kraus WE, Miller NH, Schulman KA, Spertus JA, O'Connor CM, Weinfurt KP; HF-ACTION Investigators. Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1451-9. doi: 10.1001/jama.2009.457. Erratum in: JAMA. 2009 Dec 2;302(21):2322.

title: Effects of Exercise Training on Health Status in Patients With Chronic Heart Failure

ReferenceCitation: O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Piña IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454.

title: Efficacy and Safety of Exercise Training in Patients With Chronic Heart Failure

location_facility: University of California at San Diego Medical Center

location_facility: University of California, Davis Medical Center

location_facility: Heart and Vascular Clinic of Northern Colorado

location_facility: Wake Forest University School of Medicine

location_facility: University of Manitoba Health Sciences Center

location_facility: University of Colorado Health Sciences Center

location_facility: Washington University School of Medicine

location_facility: Ahmanson-University of California Los Angeles

location_facility: University of Medicine & Dentistry of New Jersey

location_facility: Mid America Heart Institute-Saint Luke's Hospital

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: University of North Carolina School of Medicine

location_facility: University of Oklahoma Health Sciences Center


title: A Randomized, Open-Label Study of 800 Mg Lopinavir/200 Mg Ritonavir QD in Combination With Tenofovir and Emtricitabine Vs. 400 Mg Lopinavir /100 Mg Ritonavir BID in Combination With Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects

summary: The purpose of this study is to compare the safety, tolerability and antiviral activity between once-daily (QD) and twice-daily (BID) dosing of lopinavir/ritonavir and to further characterize the pharmacokinetics of once-daily dosing of lopinavir/ritonavir.

ReferenceCitation: Podsadecki TJ, Vrijens BC, Tousset EP, Rode RA, Hanna GJ. Decreased adherence to antiretroviral therapy observed prior to transient human immunodeficiency virus type 1 viremia. J Infect Dis. 2007 Dec 15;196(12):1773-8. doi: 10.1086/523704.

family: Podsadecki

full_name: Thomas J. Podsadecki

given: Thomas J.

family: Vrijens

full_name: Bernard C. Vrijens

given: Bernard C.

family: Tousset

full_name: Eric P. Tousset

given: Eric P.

family: Rode

full_name: Richard A. Rode

given: Richard A.

family: Hanna

full_name: George J. Hanna

given: George J.

journal_name: The Journal of Infectious Diseases

title: Decreased Adherence to Antiretroviral Therapy Observed prior to Transient Human Immunodeficiency Virus Type 1 Viremia

lead_sponsor: Abbott

location_country:
United States
France
Singapore
Australia
Spain
Germany
United Kingdom

location_facility: Infectious Disease Research Institute, Inc.

location_facility: Associates in Medical and Mental Health, P.C.

location_facility: Ground Zero Medical Centre / AIDS Research Initiative

location_facility: AIDS Research Consortium of Atlanta Inc.

location_facility: Orange County Center for Special Immunology

location_facility: Morris, Sklaver, Mestre & Denney, M.D., PA

location_facility: Treasure Coast Infectious Disease Consultants

location_facility: St. Stephen's Centre Chelsea & Westminster Hospital

location_facility: Klinik I fur Innere Medizin der Universitat zu Koln

location_facility: The Caldecot Centre King's Healthcare NHS Trust

location_facility: AIDS Healthcare Foundation Research Center


title: An Open Label, Phase II Study of Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART

summary: The purpose of this study is to study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first protease inhibitor based HAART.

location_country:
Italy
Brazil
United States
Germany
France
Poland
Argentina
Puerto Rico
Spain
Canada
United Kingdom

location_facility: C.H.U. Brabois - Tour Drouet, Rue du Morvan

location_facility: University of Colorado Health Sciences Center

location_facility: State University of New York at Stony Brook

location_facility: Toronto General Hospital Division of The University Health Network

location_facility: Montreal Chest Institute/Royal Victoria Hospital

location_facility: AIDS Research Consortium of Atlanta, Inc.

location_facility: Tower Infectious Diseases Medical Associates

location_facility: 20th Avenue Medical Center Kaiser Permanente

location_facility: AIDS Health Care Foundation - Research Center

location_facility: Institut fur Immunologie Pathologie und Molekularbiologie

location_facility: Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon


title: An Open Label, Phase II Study of Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra (Lopinavir/Ritonavir) as Their Second Protease Inhibitor.

summary: The purpose of this study is to study the safety and efficacy of Amprenavir/ritonavir or saquinavir/ritonavir in HIV infected patients that have failed Kaletra as their second protease inhibitor based HAART.

location_country:
Italy
Brazil
United States
France
Poland
Argentina
Puerto Rico
Spain
Canada
United Kingdom

location_facility: Service du C.I.S.I.H. - C.H.U. de Grenoble

location_facility: Infectious Disease Research Institute, Inc.

location_facility: III Infectious Diseases Division IRCCS "L. Spallanzani"

location_facility: Hospital do Servidor Publico Estadual de Sao Paulo


title: Temozolomide Versus Temozolomide + Whole Brain Radiation In Stage IV Melanoma Patients With Asymptomatic Brain Metastases

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy is more effective with or without radiation therapy in treating brain metastases.

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

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

location_country:
Italy
Austria
Switzerland
Netherlands
United Kingdom
France
Norway
Belgium
Portugal
Germany
Czech Republic

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa

location_facility: Federal Armed Forces Hospital of Ulm - Department of Dermatology

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Centre Hospital Regional Universitaire de Limoges

intervention_type: Radiation


title: Phase I and Pharmacokinetics Study to Determine the Safety of CHS 828 in Patients With a Solid Tumor on a Single Oral Dose Repeated Every 3 Weeks

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of CHS 828 in treating patients who have solid tumors.

status: Withdrawn

ReferenceCitation: Ravaud A, Cerny T, Terret C, Wanders J, Bui BN, Hess D, Droz JP, Fumoleau P, Twelves C. Phase I study and pharmacokinetic of CHS-828, a guanidino-containing compound, administered orally as a single dose every 3 weeks in solid tumours: an ECSG/EORTC study. Eur J Cancer. 2005 Mar;41(5):702-7.

location_country:
Austria
Switzerland
Netherlands
France
Norway
Belgium
Denmark
Germany
United Kingdom

location_facility: Herlev Hospital - University Hospital of Copenhagen

location_facility: Universitaetsklinik und Strahlenklinik - Essen


title: A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer

summary: This is a study consisting of four cohorts in this setting. In Cohort 1, the safety and efficacy of ipatasertib (ipat) in combination with atezolizumab (atezo) and paclitaxel (pac) or nab-paclitaxel will be evaluated for participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not previously received chemotherapy. In Cohort 2, ipatasertib and atezolizumab (with no chemotherapy), will be administered to participants with locally advanced or metastatic TNBC. In Cohort 3, the safety and efficacy of neoadjuvant ipatasertib, atezolizumab, doxorubicin and cyclophosphamide (AC) (Ipat + Atezo + AC) followed by Ipat + Atezo + Pac will be evaluated in participants with locally advanced Type 2-4 (T2-4) TNBC. In Cohort 4, the safety and efficacy of Ipat + Atezo + Pac will be evaluated in participants with PD-L1 (Programmed Death-Ligand-1) positive locally advanced or metastatic TNBC that is not amenable to resection and who have not previously received chemotherapy in the advanced setting.

status: Active, not recruiting

location_country:
France
Australia
Spain
United States
United Kingdom

location_facility: St Vincents Hospital; Cardiopulmonary transplant Ambulatory Care Dept

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

location_facility: Nottingham University Hospitals NHS Trust


title: Randomised, Double-blind, Placebo-controlled (Within Dose Groups) and Active Controlled (Eplerenone Group) Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Oral Doses of BI 690517 Over 28 Days in Female and Male Patients With Diabetic Nephropathy

summary:
The primary objective of this current trial is to investigate the safety and tolerability of 3 oral doses of BI 690517 over 28 days in female and male patients with diabetic nephropathy as add-on-therapy to Angiotensin Converting Enzyme inhibitor [ACEi] or Angiotensin-receptor blockers [ARB].

Secondary objective is to evaluate the change from baseline in Urine Albumin-to-Creatinine Ratio [UACR].

lead_sponsor: Boehringer Ingelheim

location_country:
Sweden
Spain
France
Greece
Slovakia
Russian Federation
Portugal
Denmark
Germany
United Kingdom

location_facility: Copenhagen University Hospital, Rigshospitalet

location_facility: City Clinical Hospital named after V.P. Demikhova Department of Health of Moscow

location_facility: Iatriko of Athens Group/ Iatriko of P. Faliro

location_facility: Profil Institut für Stoffwechselforschung GmbH

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Nonstate Private Healthcare Institution "Scientific Clinical Center of LLC Russian Railways"

location_facility: APDP - Associação Protectora dos Diabéticos de Portugal

location_facility: University General Hospital of Thessaloniki AHEPA

location_facility: Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António