type: Other Identifier

title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis

acronym: OCTAVE

summary: The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.

ReferenceCitation: Feagan BG, Khanna R, Sandborn WJ, Vermeire S, Reinisch W, Su C, Salese L, Fan H, Paulissen J, Woodworth DA, Niezychowski W, Sands BE. Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1442-1453. doi: 10.1111/apt.16626. Epub 2021 Oct 6.

name: Robarts Research Institute Western University London Ontario Canada

family: Feagan

full_name: Brian G. Feagan

given: Brian G.

name: Department of Medicine Division of Gastroenterology Western University London Ontario Canada

family: Khanna

full_name: Reena Khanna

given: Reena

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

family: Sandborn

full_name: William J. Sandborn

given: William J.

name: Department of Gastroenterology University Hospitals Leuven Leuven Belgium

family: Vermeire

full_name: Séverine Vermeire

given: Séverine

name: Department of Internal Medicine III Medical University of Vienna Vienna Austria

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Su

full_name: Chinyu Su

given: Chinyu

family: Salese

full_name: Leonardo Salese

given: Leonardo

family: Fan

full_name: Haiyun Fan

given: Haiyun

family: Paulissen

full_name: Jerome Paulissen

given: Jerome

family: Woodworth

full_name: Deborah A. Woodworth

given: Deborah A.

family: Niezychowski

full_name: Wojciech Niezychowski

given: Wojciech

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

family: Sands

full_name: Bruce E. Sands

given: Bruce E.

journal_name: Alimentary Pharmacology & Therapeutics

license_normalized: cc-by-nc-nd

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Farraye FA, Qazi T, Kotze PG, Moore GT, Mundayat R, Lawendy N, Sharma PP, Judd DT. The impact of body mass index on efficacy and safety in the tofacitinib OCTAVE ulcerative colitis clinical programme. Aliment Pharmacol Ther. 2021 Aug;54(4):429-440. doi: 10.1111/apt.16439. Epub 2021 Jun 24.

name: Inflammatory Bowel Disease Center Department of Gastroenterology and Hepatology Mayo Clinic Jacksonville FL USA

family: Farraye

full_name: Francis A. Farraye

given: Francis A.

name: Digestive Disease and Surgery Institute Cleveland Clinic Cleveland OH USA

family: Qazi

full_name: Taha Qazi

given: Taha

name: IBD Outpatient Clinics Colorectal Surgery Unit Cajuru University HospitalPontifical Catholic University of Paraná (PUCPR) Curitiba Brazil

family: Kotze

full_name: Paulo G. Kotze

given: Paulo G.

name: Department of Gastroenterology Monash Health Melbourne Vic. Australia

name: School of Clinical Sciences at Monash Health Monash University Melbourne Vic. Australia

family: Moore

full_name: Gregory T. Moore

given: Gregory T.

family: Mundayat

full_name: Rajiv Mundayat

given: Rajiv

family: Lawendy

full_name: Nervin Lawendy

given: Nervin

family: Sharma

ReferenceCitation: Rubin DT, Reinisch W, Greuter T, Kotze PG, Pinheiro M, Mundayat R, Maller E, Fellmann M, Lawendy N, Modesto I, Vavricka SR, Lichtenstein GR. Extraintestinal manifestations at baseline, and the effect of tofacitinib, in patients with moderate to severe ulcerative colitis. Therap Adv Gastroenterol. 2021 May 16;14:17562848211005708. doi: 10.1177/17562848211005708. eCollection 2021.

name: University of Chicago Medicine, Inflammatory Bowel Disease Center, 5841 S. Maryland Avenue, MC4076, Chicago, IL 60637, USA

name: Medical University of Vienna, Vienna, Austria

name: Department of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland

name: IBD Outpatient Clinics, Colorectal Surgery Unit, Catholic University of Paraná (PUCPR), Curitiba, Brazil

name: Pfizer Switzerland AG, Zürich, Switzerland

name: Zentrum für Gastroenterologie und Hepatologie AG, Zürich, Switzerland

name: Division of Gastroenterology, University of Pennsylvania School of Medicine, Philadelphia, PA, USA

journal_name: Therapeutic Advances in Gastroenterology

ReferenceCitation: Panés J, Vermeire S, Dubinsky MC, Loftus EV, Lawendy N, Wang W, Salese L, Su C, Modesto I, Guo X, Colombel JF. Efficacy and Safety of Tofacitinib Re-treatment for Ulcerative Colitis After Treatment Interruption: Results from the OCTAVE Clinical Trials. J Crohns Colitis. 2021 Nov 8;15(11):1852-1863. doi: 10.1093/ecco-jcc/jjab065.

name: Inflammatory Bowel Disease Unit, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain

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

name: Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY, USA

name: Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, MN, USA

name: Division of Gastroenterology, Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA

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

journal_name: Clinical Gastroenterology and Hepatology

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

name: Beijing Linking Truth Technology Co. Ltd  Shanghai China

name: Pfizer Inc  Collegeville Pennsylvania USA

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

journal_name: Clinical Pharmacology in Drug Development

ReferenceCitation: Curtis JR, Regueiro M, Yun H, Su C, DiBonaventura M, Lawendy N, Nduaka CI, Koram N, Cappelleri JC, Chan G, Modesto I, Lichtenstein GR. Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan® Administrative Claims Database With Tofacitinib Trial Data. Inflamm Bowel Dis. 2021 Aug 19;27(9):1394-1408. doi: 10.1093/ibd/izaa289.

name: Division of Clinical Immunology and Rheumatology, Department of Medicine, Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL, USA

name: Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, OH, USA

name: Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA, USA

ReferenceCitation: Colombel JF, Osterman MT, Thorpe AJ, Salese L, Nduaka CI, Zhang H, Lawendy N, Friedman GS, Quirk D, Su C, Reinisch W. Maintenance of Remission With Tofacitinib Therapy in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Oct 9. pii: S1542-3565(20)31389-6. doi: 10.1016/j.cgh.2020.10.004. [Epub ahead of print]

title: Maintenance of Remission With Tofacitinib Therapy in Patients With Ulcerative Colitis

ReferenceCitation: Sands BE, Colombel JF, Ha C, Farnier M, Armuzzi A, Quirk D, Friedman GS, Kwok K, Salese L, Su C, Taub PR. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. Inflamm Bowel Dis. 2021 May 17;27(6):797-808. doi: 10.1093/ibd/izaa227.

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

name: Inflammatory Bowel Disease Center, Cedars-Sinai Medical Center, Los Angeles, California, USA

name: PEC2, EA 7460, University of Bourgogne—Franche Comté and Department of Cardiology, CHU Dijon-Bourgogne, Dijon, France

name: IBD Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy

name: Inflammation & Immunology, Pfizer Inc, Collegeville, Pennsylvania, USA

name: Inflammation & Immunology, Pfizer Inc, New York, New York, USA

name: Division of Cardiovascular Medicine, University of California, San Diego, California, USA

title: Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib—Implications for Cardiovascular Risk and Patient Management

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

repository_institution: Newcastle Univesity - Newcastle University ePrints

repositories_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Lichtenstein GR, Rogler G, Ciorba MA, Su C, Chan G, Pedersen RD, Lawendy N, Quirk D, Nduaka CI, Thorpe AJ, Panés J. Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2021 May 17;27(6):816-825. doi: 10.1093/ibd/izaa199.

name: Division of Gastroenterology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA

name: Department of Gastroenterology and Hepatology, University of Zürich, Zürich, Switzerland

name: Division of Gastroenterology, Washington University in Saint Louis, Saint Louis, Missouri, USA

name: Pfizer Inc, Collegeville, Pennsylvania, USA

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

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

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

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

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

name: Medical University of Vienna; Vienna Austria

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

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

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

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

name: Oregon Health & Science University, Portland, Oregon

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

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

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

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

title: Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib

ReferenceCitation: Motoya S, Watanabe M, Kim HJ, Kim YH, Han DS, Yuasa H, Tabira J, Isogawa N, Arai S, Kawaguchi I, Hibi T. Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies. Intest Res. 2018 Apr;16(2):233-245. doi: 10.5217/ir.2018.16.2.233. Epub 2018 Apr 30. Erratum in: Intest Res. 2018 Jul;16(3):499-501.

name: IBD Center, Sapporo Kosei General Hospital, Sapporo, Japan.

name: Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan.

name: Division of Gastroenterology, Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea.

name: Division of Gastroenterology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

name: Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.

name: Inflammation & Immunology, Pfizer Japan Inc, Tokyo, Japan.

name: Center for Advanced IBD Research and Treatment, Kitasato University, Tokyo, Japan.

publisher: Korean Association for the Study of Intestinal Diseases

publisher_dissemination: Korean Association for the Study of Intestinal Diseases

publisher_group: Korean Association for the Study of Intestinal Diseases

publisher_normalized: Korean Association for the Study of Intestinal Diseases

ReferenceCitation: Panés J, Vermeire S, Lindsay JO, Sands BE, Su C, Friedman G, Zhang H, Yarlas A, Bayliss M, Maher S, Cappelleri JC, Bushmakin AG, Rubin DT. Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies. J Crohns Colitis. 2018 Jan 24;12(2):145-156. doi: 10.1093/ecco-jcc/jjx133. Erratum in: J Crohns Colitis. 2019 Jan 1;13(1):139-140.

name: Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK

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

name: The University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL, USA

ReferenceCitation: Sandborn WJ, Su C, Sands BE, D'Haens GR, Vermeire S, Schreiber S, Danese S, Feagan BG, Reinisch W, Niezychowski W, Friedman G, Lawendy N, Yu D, Woodworth D, Mukherjee A, Zhang H, Healey P, Panés J; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2017 May 4;376(18):1723-1736. doi: 10.1056/NEJMoa1606910.

name: From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I,...

title: Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis

location_country:
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
Ukraine
Croatia
France
Japan
Poland
Slovakia
Canada
Korea, Republic of
Colombia
South Africa
Netherlands
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Israel
New Zealand
Spain
Estonia
Latvia

location_facility: Baylor College of Medicine (Baylor Medical Center)

location_facility: Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem

location_facility: Federal state Institution "Sibirian regional Medical centre of Federal Medicobiologic Agency",

location_facility: Internal Medicine Center of Crimean Republic Institution"Clinical Territorial Medical Community"

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: Regional Municipal Institution Chernivtsi Regional Clinical Hospital,

location_facility: Hospital Universitari de Bellvitge, Servicio de Digestivo

location_facility: Oddzial Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika

location_facility: State Institution "Institute of Gastroenterology of the National Academy of Medical Sciences of

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: Municipal Institution "Odesa Regional Clinical Hospital"

location_facility: McGovern Medical School -The University of Texas Health Science Center at Houston

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"

location_facility: Carolina Research, Carolina Digestive Diseases

location_facility: Hopital Saint Louis - Service d'hepato-gastoenterologie

location_facility: X-Ray Unit, East Tallinn Central Hospital

location_facility: X- Ray Department of West Tallinn Central Hospital

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

location_facility: Limited Liability Company Medical Company "Hepatolog"

location_facility: National Hospital Organization Mito Medical Center

location_facility: UCSD Health System - Investigational Drug Pharmacy - Moores Cancer Center

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: London Health Sciences Centre - University Hospital

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

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Nemocnice Strakonice, a.s., Interni oddeleni

location_facility: VCU Health System Digestive Health Center

location_facility: ECG Unit of West Tallinn Central Hospital

location_facility: Federal state budget institution "State scientific centre of coloproctology"

location_facility: Cabinet Particular Policlinic Algomed Srl

location_facility: Shiga University of Medical Science Hospital

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Samara Diagnostic center, X-ray Department

location_facility: Peterfy Sandor Utcai Korhaz Rendelointezet es Baleseti Kozpont

location_facility: State budget institution of healthcare of Yaroslavl region Regional clinical hospital

location_facility: East Tallinn Central Hospital Internal Medical Clinic

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: The Private Practice of Simon Lichtiger, MD

location_facility: Bekes Megyei Pandy Kalman Korhaz III. Gasztroenterologiai Osztaly

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Professional Quality Research, Inc.- Austin Gastroenterology PA

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet Gasztroenterologiai Tanszek

location_facility: Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology

location_facility: Kyiv Municipal Clinical Hospital #18, Proctology Department

location_facility: Hospital de Clinicas de Porto Alegre - HCPA

location_facility: Addenbrooke's Hospital-Cambridge University Hospitals NHS Foundation Trust

location_facility: Klinika Chorob Wewnetrznych i Gastroenterologii z

location_facility: Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.

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location_facility: Department of Gastroenterology, Old Building

location_facility: East Ann Arbor Health and Geriatrics Center - UMHS

location_facility: Hopital Saint Antoine - Service de Gastroenterologie

location_facility: Saint Joseph Mercy Hospital - Inpatient Pharmacy

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Dr Rethy Pal Korhaz-Rendelointezet, III Belgyogyaszat

location_facility: Medical Science Research Building 1 - UMHS

location_facility: Chris Hani Baragwanath Academic Hospital

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: State Institution "National L.T. Malaya Therapy Institute of National Academy of

location_facility: NYU Langone Nassau Gastroenterology Associates

location_facility: Minicipal Institution City Hospital 7, Therapevtic Department,

location_facility: SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,

location_facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III

location_facility: Connecticut Clinical Research Foundation

location_facility: Spitalul Universitar de Urgenta Bucharest

location_facility: AOU Mater Domini - U.O. Fisiopatologia Digestiva

location_facility: UZ Leuven (University Hospital Leuven), Campus Gasthuisberg

location_facility: Cotton-O'Neal Clinical Research Center Digestive Health

location_facility: ECG room Clinic Linezers (ECG only) Riga East University Hospital

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital

location_facility: Houston Hospital for Specialized Surgery (Endoscopy only)

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Municipal Budget Institution of Healthcare of Novosibirsk " City Clinical Hospital No 12"

location_facility: Municipal Institution of Healthcare City Clinical Hospital 12,

location_facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine

location_facility: Citrus Surgery & Endoscopy Center (colonoscopy)

location_facility: Saint Joseph Mercy Hospital Outpatient Laboratory

location_facility: The North West London Hospitals NHS Trust

location_facility: Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych, Szpital Uniwersytecki nr 2 im

location_facility: X-Ray Department of West Tallinn Central Hospital

location_facility: Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department

location_facility: University Medical Center Groningen (UMCG)

location_facility: Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2,

location_facility: SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI "Uzhgorod Nat.

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

location_facility: Clinical Centre of Vojvodina, Emergency Internal Medicine Division

location_facility: Municipal Institution "City Hospital #7", Zaporizhzhia State Medical University

location_facility: University of Alberta - Zeidler Ledcor Centre

location_facility: Springhill Memorial Hospital (Endoscopy Only)

location_facility: Baylor College of Medicine - Baylor Medical Center (Drug Storage)

location_facility: ECG Unit, Innomedica OU and Qualitas AS (ECG Only)

location_facility: State Budget Educational Institution of Higher Professional Education

location_facility: North Florida Gastroenterology Research, LLC

location_facility: Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"

location_facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,

location_facility: Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology

location_facility: Clinical Research Institute of Michigan, LLC


title: Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer

acronym: LAPC

summary: The purpose of this study is to determine whether patients with locally advanced pancreatic cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Italy
Austria
United States
United Kingdom
Germany
France
Poland
Romania
Hungary
Australia
Belgium
Ireland
Russian Federation
Canada
Czech Republic

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis on Background of Cyclophosphamide or Rituximab Treatment

summary: The aim of this trial is to optimize the treatment to induce remission for patients with non-life-threatening anti-neutrophil cytoplasmic antibody vasculitis (AAV). The intent is to reduce the toxicity of induction therapy by reducing the overall exposure to or eliminating entirely the use of systemic corticosteroids during the induction period with an inhibitor of the complement C5a receptor plus cyclophosphamide or rituximab.

ReferenceType: derived

ReferenceCitation: Cravedi P, Leventhal J, Lakhani P, Ward SC, Donovan MJ, Heeger PS. Immune cell-derived C3a and C5a costimulate human T cell alloimmunity. Am J Transplant. 2013 Oct;13(10):2530-9. doi: 10.1111/ajt.12405. Epub 2013 Sep 6.

name: Renal Division, Department of Medicine; Icahn School of Medicine at Mount Sinai; New York NY

family: Cravedi

full_name: P. Cravedi

given: P.

sequence: first

family: Leventhal

full_name: J. Leventhal

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family: Lakhani

full_name: P. Lakhani

name: Department of Pathology; Ichan School of Medicine at Mount Sinai; New York NY

family: Ward

full_name: S. C. Ward

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family: Donovan

full_name: M. J. Donovan

given: M. J.

name: Recanati Miller Transplant Institute and Immunology Institute; Ichan School of Medicine at Mount Sinai; New York NY

family: Heeger

full_name: P. S. Heeger

given: P. S.

bso_classification: Medical research

datasource: user

genre: journal-article

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journal_name: American Journal of Transplantation

oa_colors: green hybrid

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host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

title: Immune Cell-Derived C3a and C5a Costimulate Human T Cell Alloimmunity

lead_sponsor: ChemoCentryx

location_country:
Austria
Sweden
Netherlands
France
Czechia
Poland
Hungary
Belgium
Germany
United Kingdom


ReferenceCitation: Rummel MJ, Janssens A, MacDonald D, Keating MM, Zaucha JM, Davis J, Lasher J, Babanrao Pisal C, Izquierdo M, Friedberg JW. A phase 3, randomized study of ofatumumab combined with bendamustine in rituximab-refractory iNHL (COMPLEMENT A + B study). Br J Haematol. 2021 Jun;193(6):1123-1133. doi: 10.1111/bjh.17420. Epub 2021 May 10.

name: Department for Haematology Clinic for Haematology and Medical Oncology Justus‐Liebig University‐Hospital Gießen Germany

family: Rummel

full_name: Mathias J. Rummel

given: Mathias J.

name: Department of Haematology Universitaire Ziekenhuizen Leuven Leuven Belgium

family: Janssens

full_name: Ann Janssens

given: Ann

name: Division of Haematology Dalhousie University Halifax NS Canada

family: MacDonald

full_name: David MacDonald

given: David

family: Keating

full_name: Mary‐Margaret Keating

given: Mary‐Margaret

name: Department of Haematology and Transplantology Medical University of Gdańsk Gdańsk Poland

family: Zaucha

full_name: Jan M. Zaucha

given: Jan M.

family: Davis

full_name: Jaclyn Davis

given: Jaclyn

family: Lasher

full_name: Janet Lasher

given: Janet

name: Novartis Healthcare Pvt. Ltd. Hyderabad India

family: Babanrao Pisal

full_name: Chaitali Babanrao Pisal

given: Chaitali

family: Izquierdo

full_name: Miguel Izquierdo

given: Miguel

name: Wilmot Cancer Institute University of Rochester Medical Centre Rochester NY USA

family: Friedberg

full_name: Jonathan W. Friedberg

given: Jonathan W.

journal_name: British Journal of Haematology

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

title: A phase 3, randomized study of ofatumumab combined with bendamustine in rituximab‐refractory iNHL (COMPLEMENT A + B study)

status: Terminated

study_start_date_type: Actual

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Austria
United States
Hong Kong
Germany
France
Japan
Greece
Poland
Slovakia
Argentina
Belgium
Puerto Rico
Russian Federation
Canada
United Kingdom
Ukraine

acronym: A+B

ipd_sharing: Yes

type: EudraCT Number

source: euctr

title: Randomized Open Label of Ofatumumab and Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment

summary: The purpose of this study was to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.

status_simplified: Unknown


intervention_type: Other

location_country:
Finland
Greece
Belgium
Australia
Russian Federation
Denmark
Ukraine
India
France
Poland
Norway
Argentina
Canada
Korea, Republic of
Sweden
Netherlands
Hungary
Puerto Rico
United States
Italy
Brazil
Czechia
Israel
Spain
Turkey

acronym: PROLONG

title: A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Maintenance Treatment Versus no Further Treatment in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL) Who Have Responded to Induction Therapy

summary: The purpose of this study was to determine if maintenance therapy with ofatumumab would prolong remission in patients with CLL who have responded to second or third line treatment. This study would also evaluate the safety of ofatumumab maintenance compared to observation (the current standard of care). This study was co-developed with the HOVON and NORDIC CLL group and would be conducted as a collaborative effort with GSK.


title: Attain Success Clinical Trial

summary: The purpose of the study is to assess lead implant success and complication rate using the Medtronic Attain Family of left-heart leads and delivery catheters.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
United States
India
Hong Kong
Pakistan
France
Malaysia
Poland
Thailand
Malta
Romania
Puerto Rico
Singapore
China
Germany
Canada
Taiwan

intervention_type: Device


title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Doses of Tramadol Hydrochloride Orally Disintegrating Tablets in Male Subjects With Premature Ejaculation

summary: The purpose of this clinical trial is to test an experimental drug therapy called Tramadol Hydrochloride (HCl) Orally Disintegrating Tablets (ODT) ("Tramadol HCl ODT" or the "study drug"). The subject and his partner are being asked to be in this clinical trial because they have a condition called premature ejaculation.

enrollment_type: Anticipated

ReferenceCitation: Bar-Or D, Salottolo KM, Orlando A, Winkler JV; Tramadol ODT Study Group. A randomized double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of two doses of the tramadol orally disintegrating tablet for the treatment of premature ejaculation within less than 2 minutes. Eur Urol. 2012 Apr;61(4):736-43. doi: 10.1016/j.eururo.2011.08.039. Epub 2011 Aug 30.

family: Bar-Or

full_name: David Bar-Or

family: Salottolo

full_name: Kristin M. Salottolo

given: Kristin M.

family: Orlando

full_name: Alessandro Orlando

given: Alessandro

family: Winkler

full_name: James V. Winkler

given: James V.

journal_name: European Urology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: A Randomized Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of the Tramadol Orally Disintegrating Tablet for the Treatment of Premature Ejaculation Within Less Than 2 Minutes

lead_sponsor: Bausch Health Americas, Inc.

location_country: Austria Sweden Netherlands France Belgium Spain Germany

location_facility: Medizinische Hochschule Hannover Zentrum for Seelische Gesundhelt

location_facility: Clinique St. Jean, Depart. of Urology, Blvd du Jardin Botanique, 32

location_facility: Hospital Universitario Fundacion Alcordon

location_facility: PUR/R Praxisklinik Urologie 3 Rhein Ruhr

location_facility: Hopital Raymond Poincar'e, 104 Bvld. Raymond Poincar'e

location_facility: Ziekenhuisnelwerk Antwerpen (ZNA), Campus Stuvenberg-St. Erasmus

location_facility: CHU de Nimes-Groupe Hospitalo-Universitaire, Pharmacie Secteur Essals Cliniques,

location_facility: Abetellung for Andrologie & Urologie PAN-Kilnik am Neumarkt

location_facility: Academic Medical Center, Depart. of Urology

location_facility: Institut fur Mannergesundheit Universitakslinikum Hamburg-Eppendorf

location_facility: Universitair Ziekenhuls Antwerpen (UZA), Wirjkstraat 10


ReferenceType: background

ReferenceCitation: Saiag P, Gutzmer R, Ascierto PA, Maio M, Grob JJ, Murawa P, Dreno B, Ross M, Weber J, Hauschild A, Rutkowski P, Testori A, Levchenko E, Enk A, Misery L, Vanden Abeele C, Vojtek I, Peeters O, Brichard VG, Therasse P. Prospective assessment of a gene signature potentially predictive of clinical benefit in metastatic melanoma patients following MAGE-A3 immunotherapeutic (PREDICT). Ann Oncol. 2016 Oct;27(10):1947-53. doi: 10.1093/annonc/mdw291. Epub 2016 Aug 8.

design_allocation: Non-Randomized

intervention_type: Biological

ipd_sharing_description: IPD is available via the Clinical Study Data Request site (click on the link provided below)

lead_sponsor: GlaxoSmithKline

location_country:
Italy
United States
France
Poland
Ireland
Russian Federation
Spain
Germany

acronym: PREDICT

title: GSK2132231A Antigen-Specific Cancer Immunotherapeutic as First-line Treatment of Patients With Unresectable Metastatic Melanoma

summary: The objective of this study is to evaluate the clinical activity of the GSK2132231A immunotherapeutic in patients with MAGE-A3 positive unresectable metastatic melanoma presenting with the predictive gene signature.


title: A Randomized, Double-blind, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)

acronym: BRISK TA

summary: The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
Hong Kong
Spain
France
Japan
Thailand
Argentina
Australia
China
Canada
Korea, Republic of
Taiwan

location_facility: The University Of Texas MD Anderson Cancer Center


intervention_type: Procedure

lead_sponsor: Pfizer

location_country:
Italy
Austria
Sweden
Netherlands
Finland
France
Greece
Romania
Hungary
Belgium
Spain
Denmark
Germany
United Kingdom

title: A Postauthorization Safety Surveillance Study Of Patients Switching To ReFacto AF From ReFacto Or Other Factor VIII Products In Usual Care Settings

summary: The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and other Factor VIII products.


type: U.S. NIH Grant/Contract

title: Strategic Timing of AntiRetroviral Treatment

acronym: START

summary:
Objectives:

To find out if the chance of developing a serious illness or of getting AIDS is less if patients start taking HIV medicines at a time when their cluster-of-differentiation-4 (CD4)+ cell count is still fairly high, instead of waiting until the CD4+ count is at the level where there is good evidence for starting medicines.
To learn more about how a strategy of starting HIV medicines early might affect other aspects of care, such as the chances of developing other illnesses or resistance to HIV medicines, the frequency of doctor visits, the cost of medical care, and general health and satisfaction.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Babiker AG, Emery S, Fätkenheuer G, Gordin FM, Grund B, Lundgren JD, Neaton JD, Pett SL, Phillips A, Touloumi G, Vjechaj MJ; INSIGHT START Study Group. Considerations in the rationale, design and methods of the Strategic Timing of AntiRetroviral Treatment (START) study. Clin Trials. 2013;10(1 Suppl):S5-S36. doi: 10.1177/1740774512440342. Epub 2012 Apr 30.

ReferenceType: result

ReferenceCitation: INSIGHT START Study Group, Lundgren JD, Babiker AG, Gordin F, Emery S, Grund B, Sharma S, Avihingsanon A, Cooper DA, Fätkenheuer G, Llibre JM, Molina JM, Munderi P, Schechter M, Wood R, Klingman KL, Collins S, Lane HC, Phillips AN, Neaton JD. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med. 2015 Aug 27;373(9):795-807. doi: 10.1056/NEJMoa1506816. Epub 2015 Jul 20.

journal_name: New England Journal of Medicine

oa_host_type: repository

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

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

license: cc-by-nc-nd

repository_institution: Universidad Católica de Colombia - Repositorio Institucional Universidad Católica de Colombia

version: submittedVersion

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

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

repositories_institution: Universidad Católica de Colombia - Repositorio Institucional Universidad Católica de Colombia

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection

ReferenceCitation: Ghazi L, Baker JV, Sharma S, Jain MK, Palfreeman A, Necsoi C, Murray DD, Neaton JD, Drawz PE. Role of Inflammatory Biomarkers in the Prevalence and Incidence of Hypertension Among HIV-Positive Participants in the START Trial. Am J Hypertens. 2020 Jan 1;33(1):43-52. doi: 10.1093/ajh/hpz132.

name: Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA

family: Ghazi

full_name: Lama Ghazi

given: Lama

name: Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA

family: Baker

full_name: Jason V Baker

given: Jason V

name: Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA

family: Sharma

full_name: Shweta Sharma

given: Shweta

name: Department of Medicine, University of Texas Southwestern, Dallas, Texas, USA

family: Jain

full_name: Mamta K Jain

given: Mamta K

name: Department of Infectious Diseases, University Hospitals of Leicester NHS Trust, Leicester, UK

family: Palfreeman

full_name: Adrian Palfreeman

given: Adrian

name: Service des Maladies Infectieuses, CHU St-Pierre, ULB, Bruxelles, Belgium

family: Necsoi

full_name: Coca Necsoi

given: Coca

name: The Kirby Institute for Infection and Immunity in Society, University of New South Wales, Sydney, Australia

family: Murray

full_name: Daniel D Murray

given: Daniel D

family: Neaton

full_name: James D Neaton

given: James D

name: Division of Renal Diseases and Hypertension, Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA

family: Drawz

full_name: Paul E Drawz

given: Paul E

journal_name: American Journal of Hypertension

publisher: Oxford University Press (OUP)

ReferenceCitation: Lampe FC, Rodger AJ, Burman W, Grulich A, Friedland G, Sadr WE, Neaton J, Corbelli GM, Emery S, Molina JM, Orkin C, Gatell J, Gerstoft J, Ruxrungtham K, Barbosa de Souza M, Phillips AN; INSIGHT START Study Group. Impact of early antiretroviral treatment on sexual behaviour: a randomised comparison. AIDS. 2019 Dec 1;33(15):2337-2350. doi: 10.1097/QAD.0000000000002359.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories_institution: University of Edinburgh - Edinburgh Research Explorer

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Impact of early antiretroviral treatment on sexual behaviour

ReferenceCitation: Wyman Engen N, Huppler Hullsiek K, Belloso WH, Finley E, Hudson F, Denning E, Carey C, Pearson M, Kagan J. A randomized evaluation of on-site monitoring nested in a multinational randomized trial. Clin Trials. 2020 Feb;17(1):3-14. doi: 10.1177/1740774519881616. Epub 2019 Oct 24.

name: Division of Biostatistics, University of Minnesota, Minneapolis, MN, USA

name: CICAL and Hospital Italiano de Buenos Aires, Buenos Aires, Argentina

name: Washington Veterans Affairs Medical Center, Washington, DC, USA

name: Medical Research Council Clinical Trials Unit, University College London, London, UK

name: The Kirby Institute, University of New South Wales, Sydney, NSW, Australia

name: Rigshospitalet, University of Copenhagen, Copenhagen, Denmark

name: National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA

title: A randomized evaluation of on-site monitoring nested in a multinational randomized trial

ReferenceCitation: Castillo-Mancilla JR, Phillips AN, Neaton JD, Neuhaus J, Sharma S, Baker JV, Collins S, Mannheimer S, Pett S, Touzeau-Römer V, Polizzotto MN, Lundgren JD, Gardner EM; INSIGHT START Study Group. Incomplete ART adherence is associated with higher inflammation in individuals who achieved virologic suppression in the START study. J Int AIDS Soc. 2019 Jun;22(6):e25297. doi: 10.1002/jia2.25297.

name: Medicine/Infectious Diseases University of Colorado‐AMC Aurora CO USA

name: Institute for Global Health University College London London United Kingdom

name: School of Public Health University of Minnesota Minneapolis MN USA

name: Hennepin Healthcare Research Institute Minneapolis MN USA

name: School of Medicine University of Minnesota Minneapolis MN USA

name: Harlem Hospital Center Columbia University Medical Center New York NY USA

name: Institute of Clinical Trials and Methodology University College London London United Kingdom

name: Kirby Institute University of New South Wales Sydney Australia

name: AKH Division of Immunology, Allergy and Infectious Diseases University of Vienna Medical School Vienna Austria

name: CHIP Department of Infectious Diseases Rigshospitalet Copenhagen Denmark

name: Denver Health Medical Center Denver CO USA

journal_name: Journal of the International AIDS Society

repository_institution: University of Copenhagen - Research at the University of Copenhagen

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

repository_institution: University College London - UCL Discovery

repositories:
PubMed Central
Pure (Denmark)
UCL Discovery

repositories_institution: University College London - UCL Discovery

repositories_institution: University of Copenhagen - Research at the University of Copenhagen

ReferenceCitation: Borges ÁH, Neuhaus J, Sharma S, Neaton JD, Henry K, Anagnostou O, Staub T, Emery S, Lundgren JD; INSIGHT SMART; START Study Groups. The Effect of Interrupted/Deferred Antiretroviral Therapy on Disease Risk: A SMART and START Combined Analysis. J Infect Dis. 2019 Jan 7;219(2):254-263. doi: 10.1093/infdis/jiy442.

name: Center of Excellence for Health, Infections and Immunity, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark

name: Division of Biostatistics, School of Public Health, University of Minnesota

name: Hennepin County Medical Center, Minneapolis, Minnesota

name: Centre Hospitalier de Luxembourg, Service des Maladies Infectieuses, Luxembourg

name: Faculty of Medicine, University of Queensland, Brisbane, Australia

repositories:
PubMed Central
Pure (Denmark)
espace.library.uq.edu.au

title: The Effect of Interrupted/Deferred Antiretroviral Therapy on Disease Risk: A SMART and START Combined Analysis

ReferenceCitation: Molina JM, Grund B, Gordin F, Williams I, Schechter M, Losso M, Law M, Ekong E, Mwelase N, Skoutelis A, Wiselka MJ, Vandekerckhove L, Benfield T, Munroe D, Lundgren JD, Neaton JD; INSIGHT START study group. Which HIV-infected adults with high CD4 T-cell counts benefit most from immediate initiation of antiretroviral therapy? A post-hoc subgroup analysis of the START trial. Lancet HIV. 2018 Apr;5(4):e172-e180. doi: 10.1016/S2352-3018(18)30003-1. Epub 2018 Jan 16.

ReferenceCitation: Ronit A, Sharma S, Baker JV, Mngqibisa R, Delory T, Caldeira L, Ndembi N, Lundgren JD, Phillips AN; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) Strategic Timing of Antiretroviral Treatment (START) Study Group. Serum Albumin as a Prognostic Marker for Serious Non-AIDS Endpoints in the Strategic Timing of Antiretroviral Treatment (START) Study. J Infect Dis. 2018 Jan 17;217(3):405-412. doi: 10.1093/infdis/jix350.

name: Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark

name: Infectious Diseases and Department of Medicine, Hennepin County Medical Center, Minneapolis, Minnesota

name: Enhancing Care Foundation, Durban University of Technology, South Africa

name: Department of Infectious Diseases, Hospital Saint Louis, Assistance Publique–Hôpitaux de Paris, France

name: Clínica Universitária de Doenças Infecciosas, Faculty of Medicine, Santa Maria University Hospital, University of Lisbon, Portugal

name: Institute of Human Virology Nigeria, Abuja

name: CHIP, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark

name: Research Department of Infection and Population Health, University College London Medical School, United Kingdom

ReferenceCitation: Baker JV, Sharma S, Achhra AC, Bernardino JI, Bogner JR, Duprez D, Emery S, Gazzard B, Gordin J, Grandits G, Phillips AN, Schwarze S, Soliman EZ, Spector SA, Tambussi G, Lundgren J; INSIGHT (International Network for Strategic Initiatives in Global HIV Trials) START (Strategic Timing of Antiretroviral Treatment) Study Group. Changes in Cardiovascular Disease Risk Factors With Immediate Versus Deferred Antiretroviral Therapy Initiation Among HIV-Positive Participants in the START (Strategic Timing of Antiretroviral Treatment) Trial. J Am Heart Assoc. 2017 May 22;6(5). pii: e004987. doi: 10.1161/JAHA.116.004987.

name: Department of Medicine, University of Minnesota, Minneapolis, MN

name: Division of Infectious Diseases, Hennepin County Medical Center, Minneapolis, MN

name: Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN

name: Kirby Institute, University of New South Wales, Sydney, Australia

name: Department of Medicine, Hospital La Paz, IdiPAZ, Madrid, Spain

name: Division of Infectious Diseases MedIV University Hospital of Munich, Germany

name: Chelsea and Westminster Hospital, London, United Kingdom

name: Division of Cardiology, David Geffen School of Medicine at University of California, Los Angeles, CA

name: HIV Epidemiology & Biostatistics Group, University College London, London, United Kingdom

name: European AIDS Treatment Group, Berlin, Germany

name: Epidemiological Cardiology Research Center, Wake Forest School of Medicine, Winston Salem, NC

name: Division of Pediatric Infectious Diseases, University of California San Diego and Rady Children's Hospital, San Diego, CA

name: San Raffaele Scientific Institute, Milano, Italy

name: CHIP, Department of Infectious Diseases, Rigshospitalet University of Copenhagen, Denmark

name: the INSIGHT (International Network for Strategic Initiatives in Global HIV Trials) START (Strategic Timing of Antiretroviral Treatment) Study Group

journal_name: Journal of the American Heart Association

repository_institution: Ludwid Maxmilian's Universitat Munchen - Open access LMU

repositories_institution: Ludwid Maxmilian's Universitat Munchen - Open access LMU

title: Changes in Cardiovascular Disease Risk Factors With Immediate Versus Deferred Antiretroviral Therapy Initiation Among HIV‐Positive Participants in the START (Strategic Timing of Antiretroviral Treatment) Trial

ReferenceCitation: Grady C, Touloumi G, Walker AS, Smolskis M, Sharma S, Babiker AG, Pantazis N, Tavel J, Florence E, Sanchez A, Hudson F, Papadopoulos A, Emanuel E, Clewett M, Munroe D, Denning E; INSIGHT START Informed Consent Substudy Group. A randomized trial comparing concise and standard consent forms in the START trial. PLoS One. 2017 Apr 26;12(4):e0172607. doi: 10.1371/journal.pone.0172607. eCollection 2017.

name: the INSIGHT START Informed Consent Substudy Group

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

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

title: A randomized trial comparing concise and standard consent forms in the START trial

ReferenceCitation: O'Connor J, Vjecha MJ, Phillips AN, Angus B, Cooper D, Grinsztejn B, Lopardo G, Das S, Wood R, Wilkin A, Klinker H, Kantipong P, Klingman KL, Jilich D, Herieka E, Denning E, Abubakar I, Gordin F, Lundgren JD; INSIGHT START study group. Effect of immediate initiation of antiretroviral therapy on risk of severe bacterial infections in HIV-positive people with CD4 cell counts of more than 500 cells per μL: secondary outcome results from a randomised controlled trial. Lancet HIV. 2017 Mar;4(3):e105-e112. doi: 10.1016/S2352-3018(16)30216-8. Epub 2017 Jan 5.

repositories:
PubMed Central
Pure (Denmark)
ora.ox.ac.uk

ReferenceCitation: Larson GS, Carey C, Grarup J, Hudson F, Sachi K, Vjecha MJ, Gordin F; INSIGHT Group. Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials. Clin Trials. 2016 Apr;13(2):127-36. doi: 10.1177/1740774515625974. Epub 2016 Feb 8.

name: Coordinating Centers for Biometric Research, Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA

name: Copenhagen HIV Programme, University of Copenhagen, Copenhagen, Denmark

name: Sponsored Projects Administration, University of Minnesota, Minneapolis, MN, USA

name: Veterans Affairs Medical Center, Washington, DC, USA

title: Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials

ReferenceCitation: Carr A, Grund B, Neuhaus J, Schwartz A, Bernardino JI, White D, Badel-Faesen S, Avihingsanon A, Ensrud K, Hoy J; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Prevalence of and risk factors for low bone mineral density in untreated HIV infection: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:137-46. doi: 10.1111/hiv.12242.

name: Centre for Applied Medical Research; St Vincent's Hospital; Sydney Australia

name: School of Statistics; University of Minnesota; Minneapolis MN USA

name: Division of Biostatistics; University of Minnesota; Minneapolis MN USA

name: Department of Epidemiology and Biostatistics; University of California San Francisco; San Francisco CA USA

name: Department of Internal Medicine; Hospital La Paz; IdiPAZ; Madrid Spain

name: Heart of England NHS Foundation Trust; Birmingham UK

name: Department of Medicine; Helen Joseph Hospital; University of Witwatersrand; Johannesburg South Africa

name: HIV Netherlands Australia Thailand (HIV-NAT) Research Collaboration; Thai Red Cross AIDS Research Centre; Bangkok Thailand

name: Division of Allergy and Immunology; Faculty of Medicine; Chulalongkorn University; Bangkok Thailand

name: Center for Chronic Disease Outcomes Research; University of Minnesota; Minneapolis MN USA

name: Monash University and The Alfred Hospital; Melbourne Australia

name: International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group

ReferenceCitation: Matthews GV, Neuhaus J, Bhagani S, Mehta SH, Vlahakis E, Doroana M, Naggie S, Arenas-Pinto A, Peters L, Rockstroh JK; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Baseline prevalence and predictors of liver fibrosis among HIV-positive individuals: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:129-36. doi: 10.1111/hiv.12241.

name: Kirby Institute; University of New South Wales; Sydney Australia

name: John Hopkins University; Baltimore MD USA

name: Taylor Square Private Clinic; Sydney Australia

name: Duke University School of Medicine; Durham NC USA

name: MRC Clinical Trials Unit at University College London; London UK

name: CHIP; Department of Infectious Diseases and Rheumatology; Rigshospitalet; Copenhagen Denmark

name: Department of Medicine; University of Bonn; Bonn Germany

ReferenceCitation: Kunisaki KM, Niewoehner DE, Collins G, Nixon DE, Tedaldi E, Akolo C, Kityo C, Klinker H, La Rosa A, Connett JE; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Pulmonary function in an international sample of HIV-positive, treatment-naïve adults with CD4 counts > 500 cells/μL: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:119-28. doi: 10.1111/hiv.12240.

name: Minneapolis VA Health Care System; Minneapolis MN USA

name: University of Minnesota; Minneapolis MN USA

name: Virginia Commonwealth University; Richmond VA USA

name: Temple University School of Medicine; Philadelphia PA USA

name: Institute for Human Virology Nigeria; Abuja Nigeria

name: Joint Clinical Research Center; Kampala Uganda

name: University of Wuerzburg Medical Center; Wuerzburg Germany

name: Asociación Civil IMPACTA Salud y Educación; Lima Peru

ReferenceCitation: Baker JV, Engen NW, Huppler Hullsiek K, Stephan C, Jain MK, Munderi P, Pett S, Duprez D; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Assessment of arterial elasticity among HIV-positive participants with high CD4 cell counts: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:109-18. doi: 10.1111/hiv.12239.

name: Hennepin County Medical Center; University of Minnesota; Minneapolis MN USA

name: Goethe University Hospital Frankfurt; Frankfurt Germany

name: UT Southwestern Medical Center; Parkland Health & Hospital System; Dallas TX USA

name: Uganda Virus Research Institute; Entebbe Uganda

ReferenceCitation: Wright EJ, Grund B, Cysique LA, Robertson KR, Brew BJ, Collins G, Shlay JC, Winston A, Read TR, Price RW; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Factors associated with neurocognitive test performance at baseline: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:97-108. doi: 10.1111/hiv.12238.

name: Department of Infectious Diseases; Alfred Hospital and Monash University; Melbourne Victoria Australia

name: Burnet Institute; Melbourne Victoria Australia

name: University of New South Wales; Sydney New South Wales Australia

name: Peter Duncan Neurosciences Unit St Vincent's Centre for Applied Medical Research, St Vincent's Hospital; Sydney New South Wales Australia

name: AIDS Neurological Center, Neurology; University of North Carolina; Chapel Hill NC USA

name: Department of Family Medicine; University of Colorado School of Medicine; Denver CO USA

name: Denver Public Health; Denver Health and Hospital Authority; Denver CO USA

name: Division of Medicine; Imperial College London; London UK

name: Victorian Infectious Diseases Service; Royal Melbourne Hospital; Melbourne Victoria Australia

name: Melbourne Sexual Health Centre; Alfred Health; Melbourne Victoria Australia

name: Department of Neurology; University of San Francisco California; San Francisco CA USA

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

repositories: California Digital Library - eScholarship

repositories_institution: University of California - eScholarship University of California

ReferenceCitation: Lifson AR, Grandits GA, Gardner EM, Wolff MJ, Pulik P, Williams I, Burman WJ; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Quality of life assessment among HIV-positive persons entering the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:88-96. doi: 10.1111/hiv.12237.

name: Hospital for Infectious Diseases; Warsaw Poland

ReferenceCitation: Baxter JD, Dunn D, White E, Sharma S, Geretti AM, Kozal MJ, Johnson MA, Jacoby S, Llibre JM, Lundgren J; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Global HIV-1 transmitted drug resistance in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:77-87. doi: 10.1111/hiv.12236.

name: Cooper University Hospital/Cooper Medical School of Rowan University; Camden NJ USA

name: Medical Research Council Clinical Trials Unit at University College London; London UK

name: Division of Biostatistics; School of Public Health; University of Minnesota; Minneapolis MN USA

name: Institute of Infection and Global Health; University of Liverpool; Liverpool UK

name: Yale University School of Medicine and Veterans Affairs Connecticut Healthcare System; New Haven CT USA

name: The Royal Free Hospital and University College London; London UK

name: The Kirby Institute; University of New South Wales; Sydney Australia

name: Univ Hospital Germans Trias i Pujol/‘Lluita contra la SIDA’ Foundation; Barcelona Spain

name: Copenhagen HIV Programme; Rigshospitalet; University of Copenhagen; Copenhagen Denmark

title: Global HIV-1 transmitted drug resistance in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial

ReferenceCitation: Rodger AJ, Lampe FC, Grulich AE, Fisher M, Friedland G, Phanuphak N, Bogner JR, Pereira LC, Rietmeijer C, Burman W, Phillips AN; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Transmission risk behaviour at enrolment in participants in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:64-76. doi: 10.1111/hiv.12235.

name: Research Department of Infection and Population Health; University College London; London UK

name: Brighton and Sussex Medical School; Brighton UK

name: Departments of Medicine and Epidemiology; Yale School of Medicine; New Haven CT USA

name: Thai Red Cross AIDS Research Centre; Bangkok Thailand

name: Department of Infectious Diseases; Med IV; University Hospital of Munich; Munich Germany

name: Emilio Ribas Institute of Infectious Diseases; São Paulo SP Brazil

name: Colorado School of Public Health; University of Colorado; Denver CO USA

name: University of Colorado Health Sciences Center; Denver CO USA

ReferenceCitation: Achhra AC, Mocroft A, Ross MJ, Ryom L, Lucas GM, Furrer H, Neuhaus J, Somboonwit C, Kelly M, Gatell JM, Wyatt CM; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Kidney disease in antiretroviral-naïve HIV-positive adults with high CD4 counts: prevalence and predictors of kidney disease at enrolment in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:55-63. doi: 10.1111/hiv.12234.

name: Department of Medicine; Division of Nephrology; Icahn School of Medicine at Mount Sinai; New York NY USA

name: Copenhagen HIV Programme; Rigshospitalet; University of Copenhagen, Department of Infectious Diseases, Section 2100, Finsencentret; Copenhagen Denmark

name: Department of Medicine; Division of Infectious Disease; Johns Hopkins Medicine; Baltimore MD USA

name: Department of Infectious Disease; Bern University Hospital and University of Bern; Bern Switzerland

name: Division of Biostatistics; University of Minnesota School of Public Health; Minneapolis MN USA

name: Department of Medicine; Division of Infectious Disease and International Medicine; University of South Florida; Tampa FL USA

name: Department of General Medicine; John Hunter Hospital; Newcastle Australia

name: Clinical Institute of Medicine and Dermatology; Infectious Diseases & AIDS Units; Hospital Clinic/IDIBAPS; University of Barcelona; Barcelona Spain

ReferenceCitation: Soliman EZ, Sharma S, Arastéh K, Wohl D, Achhra A, Tambussi G, O'Connor J, Stein JH, Duprez DA, Neaton JD, Phillips A; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Baseline cardiovascular risk in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:46-54. doi: 10.1111/hiv.12233.

name: Epidemiological Cardiology Research Center (EPICARE), Department of Epidemiology and Prevention, and Department of Internal Medicine−Cardiology; Wake Forest School of Medicine; Winston Salem NC USA

name: Division of Biostatistics, School of Public Health; University of Minnesota; Minneapolis MN USA

name: EPIMED/Vivantes Auguste-Viktoria-Klinikum; Berlin Germany

name: Department of Medicine; School of Medicine; University of North Carolina−Chapel Hill; Chapel Hill NC USA

name: Research Department of Infection & Population Health; University College London Medical School; London UK

name: Department of Medicine; University of Wisconsin School of Medicine and Public Health; Madison WI USA

name: Department of Medicine, Cardiovascular Division; University of Minnesota; Minneapolis MN USA

title: Baseline cardiovascular risk in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial

ReferenceCitation: Law MG, Achhra A, Deeks SG, Gazzard B, Migueles SA, Novak RM, Ristola M; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Clinical and demographic factors associated with low viral load in early untreated HIV infection in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:37-45. doi: 10.1111/hiv.12232.

name: School of Medicine; University of California at San Francisco; San Francisco CA USA

name: Chelsea and Westminster Hospital; London UK

name: HIV-Specific Immunity Section, Laboratory of Immunoregulation; National Institute of Allergy and Infectious Diseases; National Institutes of Health; Bethesda MD USA

name: University of Illinois at Chicago; Chicago IL USA

name: Helsinki University Central Hospital; Helsinki Finland

ReferenceCitation: Sharma S, Babiker AG, Emery S, Gordin FM, Lundgren JD, Neaton JN, Bakowska E, Schechter M, Wiselka MJ, Wolff MJ; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Demographic and HIV-specific characteristics of participants enrolled in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:30-6. doi: 10.1111/hiv.12231.

name: Medical Research Council (MRC) Clinical Trials Unit at University College London; London UK

name: Washington DC Veterans Affairs Medical Center and George Washington University; Washington DC USA

name: Department of Infectious Diseases; Copenhagen HIV Programme, Rigshospitalet, University of Copenhagen; Copenhagen Denmark

name: Wojewodzki Szpital Zakazny; Warsaw Poland

name: Projeto Praça Onze; Universidade Federal do Rio de Janeiro; Rio de Janeiro Brazil

name: University Hospitals of Leicester NHS Trust; Leicester Royal Infirmary; Leicester UK

name: University of Chile School of Medicine, Fundacion Arriaran; Santiago Chile

ReferenceCitation: Denning E, Sharma S, Smolskis M, Touloumi G, Walker S, Babiker A, Clewett M, Emanuel E, Florence E, Papadopoulos A, Sánchez A, Tavel J, Grady C; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:24-9. doi: 10.1111/hiv.12230.

name: Coordinating Centers for Biometric Research; Division of Biostatistics; School of Public Health; University of Minnesota; Minneapolis MN USA

name: National Institute of Allergy and Infectious Diseases (NIAID); Bethesda MD USA

name: Department of Hygiene; Epidemiology and Medical Statistics; Athens University Medical School; Athens Greece

name: Medical Research Council (MRC) Clinical Trials Unit; London UK

name: Therapeutic and Vaccine Research Program; The Kirby Institute; Faculty of Medicine; University of New South Wales; Coogee Australia

name: Department of Medical Ethics and Health Policy; Perelman School of Medicine at the University of Pennsylvania; Philadelphia PA USA

name: Institute of Tropical Medicine; Antwerp Belgium

name: 4th Department of Internal Medicine; Athens Medical School; Attikon University General Hospital; Athens Greece

name: Institute for Clinical Research, Inc.; at the Veterans Affairs Medical Center; Washington DC USA

name: Department of Bioethics; The Clinical Center; National Institutes of Health; Bethesda MD USA

ReferenceCitation: Grarup J, Rappoport C, Engen NW, Carey C, Hudson F, Denning E, Sharma S, Florence E, Vjecha MJ; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Challenges, successes and patterns of enrolment in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:14-23. doi: 10.1111/hiv.12229.

name: Copenhagen HIV Programme, Rigshospitalet University of Copenhagen  Copenhagen Denmark

name: University of California, San Francisco DOM/HIV/AIDS Division San Francisco General Hospital  San Francisco CA USA

name: Coordinating Centers for Biometric Research Division of Biostatistics School of Public Health University of Minnesota  Minneapolis MN USA

name: Kirby Institute University of New South Wales  Sydney Australia

name: Medical Research Council Clinical Trials Unit at UCL University College London  London UK

name: Institute of Tropical Medicine  Antwerp Belgium

name: Institute for Clinical Research, Inc. Veterans Affairs Medical Center  Washington DC USA

title: Challenges, successes and patterns of enrolment in the INSIGHT S trategic T iming of AntiRetroviral T reatment ( START ) trial

ReferenceCitation: Geffen N, Aagaard P, Corbelli GM, Meulbroek M, Peavy D, Rappoport C, Schwarze S, Collins S; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) Community Advisory Board. Community perspective on the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:10-3. doi: 10.1111/hiv.12228.

name: Centre for Social Science Research; University of Cape Town; Cape Town South Africa

name: Centre for Health & Infectious Disease Research; Department of Infectious Diseases and Rheumatology, Rigshospitalet; University of Copenhagen; Copenhagen Denmark

name: European AIDS Treatment Group; Rome Italy

name: Projecte dels NOMS-Hispanosida; Barcelona Spain

name: Newark EMA HIV Health Services Planning Council; Newark NJ USA

name: University of California; San Francisco CA USA

name: European AIDS Treatment Group; Berlin Germany

name: International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) Community Advisory Board

title: Community perspective on the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial

ReferenceCitation: INSIGHT Strategic Timing of AntiRetroviral Treatment (START) Study Group, Lundgren J, Babiker A, Gordin F, Emery S, Fätkenheuer G, Molina JM, Wood R, Neaton JD. Why START? Reflections that led to the conduct of this large long-term strategic HIV trial. HIV Med. 2015 Apr;16 Suppl 1:1-9. doi: 10.1111/hiv.12227.

name: The INSIGHT Strategic Timing of AntiRetroviral Treatment (START) Study Group

title: Why START? Reflections that led to the conduct of this large long-term strategic HIV trial

ReferenceCitation: Kunisaki KM, Quick H, Baker JV. HIV antiretroviral therapy reduces circulating surfactant protein-D levels. HIV Med. 2011 Oct;12(9):580-1. doi: 10.1111/j.1468-1293.2011.00920.x.

title: HIV antiretroviral therapy reduces circulating surfactant protein-D levels

location_country:
Luxembourg
Peru
Finland
Malaysia
Greece
Uganda
Australia
Belgium
Denmark
India
Morocco
France
Poland
Thailand
Norway
Nigeria
Argentina
South Africa
Chile
Sweden
Switzerland
Ireland
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mali
Mexico
Czechia
Israel
Spain
Estonia

location_facility: Otto-Wagner-Spital SMZ /Baumgartner Hoehe

location_facility: Belfast Health and Social Care Trust (RVH)

location_facility: Coventry and Warwickshire NHS partnership Trust

location_facility: Faculty Hospital Na Bulovce, Prague, Czech Rep.

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Puerto Rico-AIDS Clinical Trials Unit (PR-ACTU)

location_facility: Centro de Referencia e Treinamento DST/Aids

location_facility: Hippokration University General Hospital of Athens

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: University of Florida Health Services Center

location_facility: Center for Infectious Diseases at the UFES

location_facility: Hvidovre University Hospital, Department of Infectious Diseases

location_facility: Walter Reed National Military Medical Center

location_facility: Sheffield Teaching Hospital NHS Foundation Trust

location_facility: AIDS Research and Treatment Center of the Treasure Coast

location_facility: Universitatsklinikum Wurzburg, Medizinische Klinik und Poliklinik II, Schwerpunkt Infektiologie CRS

location_facility: Khon Kaen University, Srinagarind Hospital

location_facility: George Washington Medical Faculty Associates

location_facility: Durban International Clinical Research Site

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

location_facility: INCMNSZ (Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran)

location_facility: Florida Department of Health in Orange County/Sunshine Care Center

location_facility: Sexual Health and HIV Service - Clinic 2

location_facility: Desmond Tutu HIV Foundation Clinical Trials Unit

location_facility: Durban International Clinical Research Site (WWH)

location_facility: Rigshospitalet, Infektionsmedicinsk ambulatorium 8622

location_facility: Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS

location_facility: Hospital Escola Sao Francisco de Assis - UFRJ

location_facility: The Ohio State University Medical Center

location_facility: Asociacion Civil Impacta Salud y Educacion - Sede San Miguel

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Hospital La Princesa, Internal Medicine and Infectious Disease Service CRS

location_facility: Hospital Nacional Profesor Alejandro Posadas

location_facility: Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre)

location_facility: National Institutes of Health Clinical Center

location_facility: The Research + Education Group - Portland

location_facility: Hospital General de Agudos JM Ramos Mejia

location_facility: Helsinki University Central Hospital, Div. of Infectious Diseases CRS

location_facility: New Jersey Medical School Adult Clinical Research Center

location_facility: Institute of Human Virology-Nigeria (IHVN)

location_facility: University of Puerto Rico Pediatric Research Site

location_facility: Research Institute for Health Sciences (RIHES)

location_facility: The Research and Education Group at Portland VA Research Foundation

location_facility: Instituto de Infectologia Emilio Ribas - IIER

location_facility: Hospital Universitario Principe de Asturias

location_facility: Newland Immunology Center of Excellence (NICE)

location_facility: CAICI (Instituto Centralizado de Assistencia e Investigacion Clinica Integral)

location_facility: West Tallinn Central Hospital Infectious Diseases

location_facility: Community Research Initiative of New England

location_facility: University College London Medical School

location_facility: Hillsborough County Health Deptment/University of South Florida

location_facility: University of North Texas Health Science Center

location_facility: Asociacion Civil IMPACTA Salud y Educacion

location_facility: Infectious Diseases Associates NW FL, PA

location_facility: Hospital Interzonal General de Agudos Dr. Diego Paroissien

location_facility: Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hospitalier - H�pital Gustave Dron

location_facility: EPIMED-Gesellschaft fur epidemiologische und klinische Forschung in der MedizinmbH

location_facility: Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV

location_facility: SEI - Servi�os Especializados em Infectologia

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Klinik fur Dermatologie, Venerologie, Allergologie


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

family: Ghofrani

full_name: Hossein-Ardeschir Ghofrani

given: Hossein-Ardeschir

family: D'Armini

full_name: Andrea M. D'Armini

given: Andrea M.

family: Grimminger

full_name: Friedrich Grimminger

given: Friedrich

family: Hoeper

full_name: Marius M. Hoeper

given: Marius M.

family: Jansa

full_name: Pavel Jansa

given: Pavel

family: Kim

full_name: Nick H. Kim

given: Nick H.

family: Mayer

full_name: Eckhard Mayer

given: Eckhard

family: Simonneau

full_name: Gerald Simonneau

given: Gerald

family: Wilkins

full_name: Martin R. Wilkins

given: Martin R.

family: Fritsch

full_name: Arno Fritsch

given: Arno

family: Neuser

full_name: Dieter Neuser

given: Dieter

family: Weimann

full_name: Gerrit Weimann

given: Gerrit

family: Wang

full_name: Chen Wang

given: Chen

title: Riociguat for the Treatment of Chronic Thromboembolic Pulmonary Hypertension

ReferenceCitation: Archer SL. Riociguat for pulmonary hypertension--a glass half full. N Engl J Med. 2013 Jul 25;369(4):386-8. doi: 10.1056/NEJMe1306684.

family: Archer

full_name: Stephen L. Archer

given: Stephen L.

title: Riociguat for Pulmonary Hypertension — A Glass Half Full

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

full_name: Gérald Simonneau

given: Gérald

full_name: Andrea M D'Armini

given: Andrea M

full_name: Nick H Kim

given: Nick H

ReferenceCitation: Wang C, Jing ZC, Huang YG, Zhou DX, Liu ZH, Meier C, Nikkho S, Curram J, Zhang P, He JG. Riociguat for the treatment of pulmonary hypertension: Chinese subgroup analyses and comparison. Heart Asia. 2016 May 17;8(1):74-82. doi: 10.1136/heartasia-2015-010712. eCollection 2016.

ReferenceCitation: Ghofrani HA, Humbert M, Langleben D, Schermuly R, Stasch JP, Wilkins MR, Klinger JR. Riociguat: Mode of Action and Clinical Development in Pulmonary Hypertension. Chest. 2017 Feb;151(2):468-480. doi: 10.1016/j.chest.2016.05.024. Epub 2016 Jun 2. Review.

ReferenceCitation: Kim DY, Kim HJ, Han KH, Han SY, Heo J, Woo HY, Um SH, Kim YH, Kweon YO, Lim HY, Yoon JH, Lee WS, Lee BS, Lee HC, Ryoo BY, Yoon SK. Real-Life Experience of Sorafenib Treatment for Hepatocellular Carcinoma in Korea: From GIDEON Data. Cancer Res Treat. 2016 Oct;48(4):1243-1252. Epub 2016 Feb 24.

ReferenceCitation: Kudo M, Ikeda M, Takayama T, Numata K, Izumi N, Furuse J, Okusaka T, Kadoya M, Yamashita S, Ito Y, Kokudo N. Safety and efficacy of sorafenib in Japanese patients with hepatocellular carcinoma in clinical practice: a subgroup analysis of GIDEON. J Gastroenterol. 2016 Dec;51(12):1150-1160. Epub 2016 Apr 22.

ReferenceCitation: Kim NH, D'Armini AM, Grimminger F, Grünig E, Hoeper MM, Jansa P, Mayer E, Neurohr C, Simonneau G, Torbicki A, Wang C, Fritsch A, Davie N, Ghofrani HA. Haemodynamic effects of riociguat in inoperable/recurrent chronic thromboembolic pulmonary hypertension. Heart. 2017 Apr;103(8):599-606. doi: 10.1136/heartjnl-2016-309621. Epub 2016 Dec 23.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

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

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

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

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

location_facility:
Hopital Antoine Beclere
Vseobecna fakultni nemocnice

title: Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

summary: The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).


title: A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome

summary: The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

ReferenceCitation: Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.

family: Gibson

full_name: William J. Gibson

given: William J.

family: Nafee

full_name: Tarek Nafee

given: Tarek

family: Travis

full_name: Ryan Travis

given: Ryan

family: Yee

full_name: Megan Yee

given: Megan

family: Kerneis

full_name: Mathieu Kerneis

given: Mathieu

family: Ohman

full_name: Magnus Ohman

given: Magnus

full_name: C. Michael Gibson

given: C. Michael

journal_name: Journal of Thrombosis and Thrombolysis

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Gibson CM, Levitan B, Gibson WJ, Yee MK, Murphy SA, Yuan Z, Chakrabarti AK, Lee M, Braunwald E. Fatal or Irreversible Bleeding and Ischemic Events With Rivaroxaban in Acute Coronary Syndrome. J Am Coll Cardiol. 2018 Jul 10;72(2):129-136. doi: 10.1016/j.jacc.2018.04.055.

family: Levitan

full_name: Bennett Levitan

given: Bennett

full_name: Megan K. Yee

given: Megan K.

family: Murphy

full_name: Sabina A. Murphy

given: Sabina A.

family: Yuan

full_name: Zhong Yuan

given: Zhong

family: Chakrabarti

full_name: Anjan K. Chakrabarti

given: Anjan K.

family: Lee

full_name: Michael Lee

given: Michael

family: Braunwald

full_name: Eugene Braunwald

given: Eugene

journal_name: Journal of the American College of Cardiology

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Cavender MA, Gibson CM, Braunwald E, Wiviott SD, Murphy SA, Toda Kato E, Plotnikov AN, Amuchástegui M, Oude Ophuis T, van Hessen M, Mega JL. The effect of rivaroxaban on myocardial infarction in the ATLAS ACS 2 - TIMI 51 trial. Eur Heart J Acute Cardiovasc Care. 2015 Oct;4(5):468-74. doi: 10.1177/2048872614554109. Epub 2014 Oct 15.

name: TIMI Study Group, Heart & Vascular Center, Brigham and Women’s Hospital and Harvard Medical School, USA

family: Cavender

full_name: Matthew A Cavender

given: Matthew A

name: Janssen Research and Development, LLC, USA

name: Hospital Privado, Centro Médico de Córdoba, Argentina

name: Department of Cardiology, Canisius Wilhelmina Ziekenhuis, The Netherlands

name: Department of Cardiology, Groene Hart Hospital, The Netherlands

journal_name: European Heart Journal: Acute Cardiovascular Care

ReferenceCitation: Gibson CM, Chakrabarti AK, Mega J, Bode C, Bassand JP, Verheugt FW, Bhatt DL, Goto S, Cohen M, Mohanavelu S, Burton P, Stone G, Braunwald E; ATLAS-ACS 2 TIMI 51 Investigators. Reduction of stent thrombosis in patients with acute coronary syndromes treated with rivaroxaban in ATLAS-ACS 2 TIMI 51. J Am Coll Cardiol. 2013 Jul 23;62(4):286-90. doi: 10.1016/j.jacc.2013.03.041. Epub 2013 Apr 16.

title: Reduction of Stent Thrombosis in Patients With Acute Coronary Syndromes Treated With Rivaroxaban in ATLAS-ACS 2 TIMI 51

ReferenceCitation: Mega JL, Braunwald E, Murphy SA, Plotnikov AN, Burton P, Kiss RG, Parkhomenko A, Tendera M, Widimsky P, Gibson CM. Rivaroxaban in patients stabilized after a ST-segment elevation myocardial infarction: results from the ATLAS ACS-2-TIMI-51 trial (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis In Myocardial Infarction-51). J Am Coll Cardiol. 2013 May 7;61(18):1853-9. doi: 10.1016/j.jacc.2013.01.066. Epub 2013 Mar 7.

title: Rivaroxaban in Patients Stabilized After a ST-Segment Elevation Myocardial Infarction

ReferenceCitation: Mega JL, Braunwald E, Wiviott SD, Bassand JP, Bhatt DL, Bode C, Burton P, Cohen M, Cook-Bruns N, Fox KA, Goto S, Murphy SA, Plotnikov AN, Schneider D, Sun X, Verheugt FW, Gibson CM; ATLAS ACS 2-TIMI 51 Investigators. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med. 2012 Jan 5;366(1):9-19. doi: 10.1056/NEJMoa1112277. Epub 2011 Nov 13.

repository_institution: University of Luxembourg - Open Repository and Bibliography

title: Rivaroxaban in Patients with a Recent Acute Coronary Syndrome

ReferenceCitation: Gibson CM, Mega JL, Burton P, Goto S, Verheugt F, Bode C, Plotnikov A, Sun X, Cook-Bruns N, Braunwald E. Rationale and design of the Anti-Xa therapy to lower cardiovascular events in addition to standard therapy in subjects with acute coronary syndrome-thrombolysis in myocardial infarction 51 (ATLAS-ACS 2 TIMI 51) trial: a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome. Am Heart J. 2011 May;161(5):815-821.e6. doi: 10.1016/j.ahj.2011.01.026.

title: Rationale and design of the Anti-Xa Therapy to Lower cardiovascular events in Addition to standard therapy in Subjects with Acute Coronary Syndrome–Thrombolysis in Myocardial Infarction 51 (ATLAS-ACS 2 TIMI 51) trial: A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome

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

location_country:
Malaysia
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Czech Republic
Ukraine
India
Morocco
Spain
Croatia
France
Japan
Lithuania
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
Colombia
Chile
Sweden
Netherlands
Philippines
Bulgaria
Hungary
China
Portugal
Germany
United States
United Kingdom
Brazil
Serbia
Mexico
Israel
Tunisia
Egypt
New Zealand
Turkey
Latvia


ReferenceCitation: Albers GW, von Kummer R, Truelsen T, Jensen JK, Ravn GM, Grønning BA, Chabriat H, Chang KC, Davalos AE, Ford GA, Grotta J, Kaste M, Schwamm LH, Shuaib A; DIAS-3 Investigators. Safety and efficacy of desmoteplase given 3-9 h after ischaemic stroke in patients with occlusion or high-grade stenosis in major cerebral arteries (DIAS-3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Neurol. 2015 Jun;14(6):575-84. doi: 10.1016/S1474-4422(15)00047-2. Epub 2015 Apr 30.

family: Albers

full_name: Gregory W Albers

given: Gregory W

family: von Kummer

full_name: Rüdiger von Kummer

given: Rüdiger

family: Truelsen

full_name: Thomas Truelsen

given: Thomas

family: Jensen

full_name: Jens-Kristian S Jensen

given: Jens-Kristian S

family: Ravn

full_name: Gabriela M Ravn

given: Gabriela M

family: Grønning

full_name: Bjørn A Grønning

given: Bjørn A

family: Chabriat

full_name: Hugues Chabriat

given: Hugues

family: Chang

full_name: Ku-Chou Chang

given: Ku-Chou

family: Davalos

full_name: Antonio E Davalos

given: Antonio E

family: Ford

full_name: Gary A Ford

given: Gary A

family: Grotta

full_name: James Grotta

given: James

family: Kaste

full_name: Markku Kaste

given: Markku

family: Schwamm

full_name: Lee H Schwamm

given: Lee H

family: Shuaib

full_name: Ashfaq Shuaib

given: Ashfaq

journal_name: The Lancet Neurology

title: Safety and efficacy of desmoteplase given 3–9 h after ischaemic stroke in patients with occlusion or high-grade stenosis in major cerebral arteries (DIAS-3): a double-blind, randomised, placebo-controlled phase 3 trial

lead_sponsor: H. Lundbeck A/S

location_country:
Austria
India
Hong Kong
Netherlands
Philippines
Switzerland
Vietnam
France
Poland
Thailand
Singapore
Australia
Spain
Estonia
Germany
Korea, Republic of
Taiwan

title: A Randomised, Double-blind, Parallel-group Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Desmoteplase in Subjects With Acute Ischemic Stroke

summary: The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of stroke symptoms.


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia Following Second-Line Therapy (The Continuum Trial)

summary: The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective as a maintenance therapy at improving further the quality of the response you achieved with your last therapy and at prolonging the duration of your response. This study will compare the effects (good and bad) of lenalidomide with the dummy drug.

ReferenceCitation: Chanan-Khan AA, Zaritskey A, Egyed M, Vokurka S, Semochkin S, Schuh A, Kassis J, Simpson D, Zhang J, Purse B, Foà R. Lenalidomide maintenance therapy in previously treated chronic lymphocytic leukaemia (CONTINUUM): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Haematol. 2017 Nov;4(11):e534-e543. doi: 10.1016/S2352-3026(17)30168-0. Epub 2017 Sep 25.

family: Chanan-Khan

full_name: Asher A Chanan-Khan

given: Asher A

family: Zaritskey

full_name: Andrey Zaritskey

given: Andrey

family: Egyed

full_name: Miklos Egyed

given: Miklos

family: Vokurka

full_name: Samuel Vokurka

given: Samuel

family: Semochkin

full_name: Sergey Semochkin

given: Sergey

family: Schuh

full_name: Anna Schuh

given: Anna

family: Kassis

full_name: Jeannine Kassis

given: Jeannine

family: Simpson

full_name: David Simpson

given: David

family: Zhang

full_name: Jennie Zhang

given: Jennie

family: Purse

full_name: Brendan Purse

given: Brendan

family: Foà

full_name: Robin Foà

given: Robin

journal_name: The Lancet Haematology

lead_sponsor: Celgene

location_country:
Romania
Australia
Belgium
Russian Federation
Denmark
France
Poland
Canada
Colombia
South Africa
Sweden
Netherlands
Hungary
Ireland
Portugal
United States
Germany
United Kingdom
Italy
Austria
Mexico
Czechia
Israel
New Zealand
Spain

location_facility: Facharzte fur Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis

location_facility: The Cancer Center, Hackensack University Medical Center

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Biomedical Research Alliance of New York, LLC

location_facility: GUZ Volgograd Regional Clinical Oncology

location_facility: GUS Leningrad Regional Clinical Hospital

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Haematology and Oncology Clinics of Australasia

location_facility: St. Petersburg Pavlov State Medical Univ

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Szegedi TudomanyegyetemII Belgyogyaszati Klinika

location_facility: FGU Russian Scientific Research Institute of Haematology and Transfusiology of Federal Agency

location_facility: Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services

location_facility: Siouxland Hematology-Oncology Associates, LLP

location_facility: Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi

location_facility: Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza

location_facility: Hematology Oncology Assoc. of IL Orchard Research LLC

location_facility: IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: State Healthcare Institution Sverdlovsk regional clinical hospital 1

location_facility: Singleton Hospital, Southwest Wales Cancer Inst

location_facility: Azienda Policlinico Umberto I, Universita La Sapienzadi Roma

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: SUNY Upstate Medical University Medicine Oncology

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: Regional Health Authority B-Saint John Regional Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: State Budgetary Institution of the City of Moscow

location_facility: Federal State Institution Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: Innere Medizin Klinikum Frankfurt Oder GmBH

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Federal State Budgetary Establishment Medical Radiological Research Center Ministry of Health and so

location_facility: Florida Hospital Cancer Institute Waterman

location_facility: Drexel University, College of Medicine, Clinical Research Group

location_facility: Charite, Campus Benjamin Franklin, Medizinische Klinik III

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Universitaetsklinikum FreiburgInnere Med.1, Haematologie

location_facility: Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute

location_facility: Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar

location_facility: Istituto dei Tumori Giovanni Paolo II di Bari

location_facility: General Faculty Hosital1.Internal Clinic

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Praxis fuer Haematologie und Onkologie Koblenz

location_facility: Clinical Unit for Research Trials in Skin CURTIS Massachusetts General Hospital

location_facility: Specjalistyczny Szpital miejski im. Kopernika

location_facility: Kaiser Permanente Northwest Oncology Hematology

location_facility: Wilgers Oncology CentreWilgrers Hospital

location_facility: Hopital Petie- SalpetriereDepartment d'Hematologie

location_facility: CMRU-Hotel Dieu Service Hematologie Clinique et Therapie Cellulaire

location_facility: St. Bartholomew's and The Royal London Hospital

location_facility: Azienda Ospedaliero Universitaria OORR Foggia

location_facility: Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust

location_facility: Royal North Shore HospitalDepartment of HematologyLevel 4

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Instituto Portugues Oncologia do Porto Francisco Gentil EPE

location_facility: Abington Hematology Oncology Associates Inc

location_facility: Universitaetsklinikum EssenZentrum fuer Innere Medizin

location_facility: Northwestern University, Division of Hematology Oncology, Dept. of Medicine

location_facility: Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl

location_facility: Hospital General Universitario Morales Messeguer

location_facility: University Hospitals Cleveland Medical Center

location_facility: Clinical Trials Unit The St George Hospital

location_facility: Azienda Ospedaliera Vittorio Emanuele-Ferrarotto

location_facility: Azienda Ospedaliero Universitaria di Modena

location_facility: Medical University of Vienna Internalmedicine 1, Hematology

location_facility: Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center

location_facility: Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko


title: A Phase III, Randomized, Double-blind, Placebo-controlled Multi-center Study of ASA404 in Combination With Docetaxel in Second-line Treatment of Patients With Locally Advanced or Metastatic (Stage IIIb/IV) Non-small Cell Lung Cancer (NSCLC)

summary: The purpose of this study is to determine if adding ASA404 to docetaxel chemotherapy makes the cancer treatment more effective in patients with locally advanced or metastatic non-small cell lung cancer

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

location_facility: Harry & Jeannette Weinberg Cancer Institute

location_facility: Palo Alto Medical Foundation - Camino Div.

location_facility: California Pacific Medical Research Institute

location_facility: Cancer Care Specialists of Central Illinois

location_facility: North Valley Hematology/Oncology Medical Group

location_facility: Mamie McFadden Ward Cancer Ctr, Texas Oncology

location_facility: Cancer Care & Hematology Specialists of Chicagoland

location_facility: Hematology/Oncology Associates of Treasure Coast

location_facility: Texas Oncology Cancer Care Center & Research Center

location_facility: University of California Irvine Medical Center

location_facility: Central Hematology Oncology Medical Group

location_facility: Ventura County Hematology/Oncology Specialists