ReferenceCitation: Mitha E, Krivan G, Jacobs F, Nagler A, Alrabaa S, Mykietiuk A, Kenwright A, Le Pogam S, Clinch B, Vareikiene L. Safety, Resistance, and Efficacy Results from a Phase IIIb Study of Conventional- and Double-Dose Oseltamivir Regimens for Treatment of Influenza in Immunocompromised Patients. Infect Dis Ther. 2019 Dec;8(4):613-626. doi: 10.1007/s40121-019-00271-8. Epub 2019 Oct 30.

family: Mitha

full_name: Essack Mitha

given: Essack

family: Krivan

full_name: Gergely Krivan

given: Gergely

full_name: Frederique Jacobs

given: Frederique

family: Nagler

full_name: Arnon Nagler

given: Arnon

family: Alrabaa

full_name: Sally Alrabaa

given: Sally

family: Mykietiuk

full_name: Analia Mykietiuk

given: Analia

family: Kenwright

full_name: Andrew Kenwright

given: Andrew

family: Le Pogam

full_name: Sophie Le Pogam

given: Sophie

family: Clinch

full_name: Barry Clinch

given: Barry

family: Vareikiene

full_name: Loreta Vareikiene

given: Loreta

journal_name: Infectious Diseases and Therapy

license: implied-oa

license_normalized: implied-oa

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

intervention_type: Other

location_country:
Guatemala
Romania
Belgium
Ukraine
France
Poland
Lithuania
Argentina
Canada
Colombia
South Africa
Chile
Switzerland
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Estonia
Latvia

location_facility: Uni of Pennsylvania; Infectious Diseases

location_facility: University of Colorado; Kidney Transplant Center Office of Dr. Laurence Chan

location_facility: The Institute of Hematology and Blood Transfusion Transplantation Unit; Hematology and Blood Transf

location_facility: Tartu University Hospital; Department of Infectious Diseases

location_facility: Sammons Cancer Center-Baylor University; Blood & Marrow Transplantation

location_facility: Institute of Nephrology AMS; Dept of Nephrology & dialysis

location_facility: Azienda Ospedaliera; Divisione Malattie Infettive E Tropicali

location_facility: Western New England Renal & Transplant Associates, P.C.

location_facility: Rush Uni Medical Center; Medicine/ Section of Infectious Diseases

location_facility: Wojewodzki Szp.Specjalistyczny im.K.Dluskiego w Bialymstoku

location_facility: All Children'S Hospital; Pediatric Blood & Marrow Transplant Program

location_facility: Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

location_facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza

location_facility: Chaim Sheba MC; Pediatric Hematology Oncology

location_facility: Northwestern Memorial Hospital; Divison of Infectious Diseases/ Dept of Medicine

location_facility: Institutul de Urologie Si Transplant Renal Fundeni

location_facility: Hospital de Especialidades del Centro Medico Puerta de Hierr

location_facility: University of Pennsylvania Health System

location_facility: POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Novant Health Pulmonary and Critical Care

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Cleveland Clinic Foundation; Infectious Disease

location_facility: SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie

location_facility: UNI-Klinikum Heidelberg Chirurgische Klinik

location_facility: Scott and White Division of Nephrology Dept of Medicine

location_facility: UT Southwestern Medical Center; Pediatrics Dept.

location_facility: Tartu Uni Hospital; Hematology - Oncology Clinic

location_facility: Hospital Clinico San Carlos; Servicio de Nefrologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Pediatria

location_facility: Debreceni Egyetem, Orvos- és Egészségtudományi Centrum;

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.

location_facility: Szpital Dzieciatka Jezus-Centrum Lecezenia Obrazen; Dpt of Transplantation Medicine & Nephrology

location_facility: Uniklinik RWTH Aachen; Med. Klinik II; Klinik für Nephrologie und klinische Immunologie

location_facility: Hospital Universitario La Paz; Hepatología y Trasplantes

location_facility: Vilnius University Hospital Santariskiu Clinic

location_facility: Nazih Zuhdi Transplant Inst. ; Integris Baptist Medical Center

location_facility: Klaipeda University Hospital; Public Institution

location_facility: Uni of Alabama At Birmingham; Division of Nephrology

location_facility: Centro de Investigacion Clínica GRAMEL S.C

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador; Infectologia

location_facility: ASST DI MONZA; Divisione Malattie Infettive

location_facility: Siauliai Republican Hospital Public Institution

location_facility: Tygerberg Hospital Pediatrics and Child Health

location_facility: Universitätsspital Zürich; Klinik für Nephrologie

location_facility: SPZOZ Uniwersytecki Szp Klin; nr1 im.N.Barlickiego UM

location_facility: North Estonia medical Centre; Hematology

location_facility: Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Ludwig-Maximilians-Universitaet; Medizinische Klinik und Poliklinik IV

location_facility: West Tallinn Central Hospital; Nephrology

location_facility: Hopital Saint Louis; Service de Nephrologie - Transplantation

location_facility: Uni of Cincinnati Medical Center; Nephrology & Hypertension

location_facility: Hospital Roosevelt Guatemala; Clinica de Infecciosas

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Dipartimento Malattie Infettive

location_facility: KASMED, s.r.o.; Alergologie a klinicka imunologie

location_facility: Specialized Hospital for children with oncohaematologica Diseases; Dept. Of Transplantations

location_facility: Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas

location_facility: Charite - Campus Virchow Klinikum; Abteilung fuer Chirurgie

location_facility: Fov.Onk.Egyesitett Szt. Istvan es Szt Laszlo Korh.-Rend.Int.

location_facility: University of Maryland School of Medicine

location_facility: Hospital General de Agudos Juan Antonio Fernandez; infectología

location_facility: UMHA - Sv. Georgi; Clinic of Nephrology & Haemodialysis

location_facility: M.D Anderson Cancer Center; Infectious Diseases, Infection Control, and Employee Health

location_facility: CALIFORNIA PACIFIC MEDICAL CENTER; Office of Dr. Venkat Peddi

location_facility: Rabin Medical Center-Golda Campus - Hasharon; Department of Transplantation

location_facility: Chaim Sheba Medical Center; Hematology BMT & CBB

location_facility: Wake Forest University Baptist Medical Center

location_facility: Medical College of Georgia; Medicine/ Nephrology

location_facility: Hadassah University Hospital - Ein Kerem; BMT & Cancer Immunotherapy Dept.

location_facility: University of Utah Health Science Center Gastroenterology

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Centro de Investigaciones Clinicas Viña del Mar

location_facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde; Infectología piso 7

location_facility: Medical University of South Carolina; Pediatric Cardiology

location_facility: Hospital Universitario la Paz; Servicio de Enfermedades Infecciosas - HIV unit

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: University of Szeged; Transplantation Department

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico; Clinica Pediatica De Macchi

location_facility: Our Lady of Lourdes Medical Center; Transplant Dept

location_facility: University of Alabama at Birmingham; Pediatric Nephrology

location_facility: Nottingham City Hospital; Transplant Unit

location_facility: Children'S Hospital of Pittsburgh; Infectious Disease

location_facility: Hospital Universitario 12 de Octubre; HIV Unit

location_facility: Latvia Transplantation Center P. Stradina Hospital; Transplantation

location_facility: INER- Instituto Nacional de Enfermedades Respiratorias"Ismae

location_facility: Mhat Alexandrovska Ead ; Clinic of Nephrology & Transplantation, Uni Hospital

location_facility: Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego

location_facility: Manchester Royal Infirmary; Renal Transplant Unit

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Centro de Investigaciones Clinicas S.A.S

location_facility: Republican Tuberculosis and Infectious Diseases University H

location_facility: Hospital Universitari de Bellvitge; Servicio de Nefrologia

location_facility: Hospital Luis Calvo Mackenna; Unidad de Investigacion

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Enfermedades Infecciosas

location_facility: Phylaxis Clinical Research S de RL de CV

location_facility: Hospital General de Agudos Dr. Ignacio Pirovano

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University of Texas Health Science Center Transplant center

location_facility: Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building

location_facility: Hopital Robert Debre; Pediatric Hematology Dept

location_facility: Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos

location_facility: Lugansk Regional Clinical Hospital; Chair of Therapy Faculty of Postgr.Ed

location_facility: Baylor University Medical Center Transplant Administration

location_facility: University of California Davis Health System

location_facility: Synexus Clinical Research Centres SA Stanza Bopape

location_facility: Wayne State University School of Medicine

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: Hospital Universitario de Monterrey; Infectologia

location_facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

location_facility: Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.

location_facility: UMHAT Sv. Georgi, EAD; Clinic of Infectious Diseases

location_facility: Hopital Europeen Georges Pompidou; Service de Nephrologie

location_facility: Uni of Michigan Medical Center; Internal Medicine/ Infectious Disease

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

location_facility: Zaporozhye State Medical University; Dept of Transplantology

location_facility: Mount Sinai Medical Center; Division of Liver Diseases

location_facility: Fakultni nemocnice v Motole; Klinika detske hematologie a onkologie UK 2.LF

location_facility: EMORY UNIVERSITY; Bone Marrow & Stem Cell Transplant Center

location_facility: Texas Tech University Health Sciences Center; Department of Urology

location_facility: Universitaetsklinikum Muenster; Paedriatrische Haematologie und Onkologie

location_facility: Kaunas Clinics Public Institution; Clinic of Nephrology

location_facility: Fundacion Cardiovascular de Colombia - Instituto del Corazón

location_facility: Henry Ford Health System; Gastroenterology

location_facility: University of Chicago; Infectious Disease

location_facility: Tartu Uni Clinics; Clinic of Surgery & Internal Medicine Dept of Nephrology

location_facility: Ukrainian Pediatric Specialized Hospital of Ministry of Health of Ukraine Dept of BMT

title: A Double-Blind, Randomized, Stratified Multi-Center Trial Evaluating Conventional and Double Dose Oseltamivir in the Treatment of Immunocompromised Patients With Influenza

summary: This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams [mg] to 75 mg twice daily orally [po], depending on age and weight) or double dose (60 mg-150 mg twice daily po depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.


title: A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response

summary: To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
Austria
Netherlands
Germany
France
Puerto Rico
United States
United Kingdom
Canada

location_facility: University of Miami Center for Liver Diseases

location_facility: Columbia Gastroenterology Associates, PA

location_facility: University of Colorado Health Sciences Center

location_facility: Virology Treatment Center, Maine Medical Center

location_facility: University of British Columbia Vancouver General Hospital

location_facility: University of Massachusetts Memorial Medical Center

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A 26-week Treatment, Randomized, Multicenter, Double-blind, Double-dummy, Parallel-group Study to Assess the Safety of Indacaterol (300 and 600 µg o.d.) in Patients With Moderate to Severe Persistent Asthma, Using Salmeterol (50 µg b.i.d.) as an Active Control

summary: This study was designed to assess the safety of indacaterol (300 µg and 600 µg (2 x 300 μg capsules) once daily [od]), compared with salmeterol (50 μg twice a day [b.i.d.]), over 26 weeks, in patients with moderate to severe persistent asthma.

design_allocation: Randomized

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Peru
Germany
France
Slovakia
Hungary
Argentina
Spain
Turkey
Canada
Czech Republic

location_facility:
Novartis Investigator site
Novartis Investigator Site
Novartis Investigator Site x 2 sites
Novartis Investigative Site


title: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study, to Evaluate the Safety, Tolerability and Efficacy of Daily Oral Administration of Laquinimod 0.6 mg in Subjects With RRMS

acronym: ALLEGRO

summary: Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).

study_start_date_type: Actual

ReferenceType: derived

ReferenceCitation: Kolb-Sobieraj C, Gupta S, Weinstock-Guttman B. Laquinimod therapy in multiple sclerosis: a comprehensive review. Neurol Ther. 2014 May 6;3(1):29-39. doi: 10.1007/s40120-014-0017-6. eCollection 2014 Jun. Review.

family: Kolb-Sobieraj

full_name: Channa Kolb-Sobieraj

given: Channa

sequence: first

family: Gupta

full_name: Sahil Gupta

given: Sahil

sequence: additional

family: Weinstock-Guttman

full_name: Bianca Weinstock-Guttman

given: Bianca

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Neurology and Therapy

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Laquinimod Therapy in Multiple Sclerosis: A Comprehensive Review

ReferenceCitation: Filippi M, Rocca MA, Pagani E, De Stefano N, Jeffery D, Kappos L, Montalban X, Boyko AN, Comi G; ALLEGRO Study Group. Placebo-controlled trial of oral laquinimod in multiple sclerosis: MRI evidence of an effect on brain tissue damage. J Neurol Neurosurg Psychiatry. 2014 Aug;85(8):851-8. doi: 10.1136/jnnp-2013-306132. Epub 2013 Sep 12.

family: Filippi

full_name: M. Filippi

given: M.

family: Rocca

full_name: M. A. Rocca

given: M. A.

family: Pagani

full_name: E. Pagani

given: E.

family: De Stefano

full_name: N. De Stefano

given: N.

family: Jeffery

full_name: D. Jeffery

given: D.

family: Kappos

full_name: L. Kappos

given: L.

family: Montalban

full_name: X. Montalban

given: X.

family: Boyko

full_name: A. N. Boyko

given: A. N.

family: Comi

full_name: G. Comi

given: G.

full_name: M. Rocca

family: Absinta

full_name: M. Absinta

family: Longoni

full_name: G. Longoni

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

ReferenceCitation: Comi G, Jeffery D, Kappos L, Montalban X, Boyko A, Rocca MA, Filippi M; ALLEGRO Study Group. Placebo-controlled trial of oral laquinimod for multiple sclerosis. N Engl J Med. 2012 Mar 15;366(11):1000-9. doi: 10.1056/NEJMoa1104318.

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

title: Placebo-Controlled Trial of Oral Laquinimod for Multiple Sclerosis

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Romania
Russian Federation
Ukraine
France
Poland
Lithuania
Canada
Turkey
Sweden
Netherlands
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Austria
Serbia
Czechia
Israel
Georgia
Spain
Estonia
Latvia

location_facility:
Teva Investigational Site 3142
Teva Investigational Site 3809
Teva Investigational Site 555
Teva Investigational Site 5116
Teva Investigational Site 1098
Teva Investigational Site 3135
Teva Investigational Site 5705
Teva Investigational Site 5117
Teva Investigational Site 1129
Teva Investigational Site 5901
Teva Investigational Site 1128
Teva Investigational Site 3248
Teva Investigational Site 1090
Teva Investigational Site 5115
Teva Investigational Site 8033
Teva Investigational Site 3046
Teva Investigational Site 3146
Teva Investigational Site 5022
Teva Investigational Site 5114
Teva Investigational Site 8030
Teva Investigational Site 3251
Teva Investigational Site 5025
Teva Investigational Site 1085
Teva Investigational Site 3047
Teva Investigational Site 5211
Teva Investigational Site 1075
Teva Investigational Site 1096
Teva Investigational Site 3132
Teva Investigational Site 1073
Teva Investigational Site 5212
Teva Investigational Site 5800
Teva Investigational Site 3138
Teva Investigational Site 3133
Teva Investigational Site 3144
Teva Investigational Site 1086
Teva Investigational Site 1081
Teva Investigational Site 5505
Teva Investigational Site 3524
Teva Investigational Site 5209
Teva Investigational Site 5026
Teva Investigational Site 1093
Teva Investigational Site 3300
Teva Investigational Site 5318
Teva Investigational Site 1078
Teva Investigational Site 5024
Teva Investigational Site 5021
Teva Investigational Site 3247
Teva Investigational Site 1097
Teva Investigational Site 5504
Teva Investigational Site 1088
Teva Investigational Site 3526
Teva Investigational Site 3240
Teva Investigational Site 3303
Teva Investigational Site 1087
Teva Investigational Site 5903
Teva Investigational Site 5027
Teva Investigational Site 3140
Teva Investigational Site 5320
Teva Investigational Site 1100
Teva Investigational Site 3137
Teva Investigational Site 5905
Teva Investigational Site 3238
Teva Investigational Site 5316
Teva Investigational Site 4204
Teva Investigational Site 1092
Teva Investigational Site 3042
Teva Investigational Site 3039
Teva Investigational Site 3241
Teva Investigational Site 5029
Teva Investigational Site 8201
Teva Investigational Site 1079
Teva Investigational Site 3044
Teva Investigational Site 1102
Teva Investigational Site 3527
Teva Investigational Site 5030
Teva Investigational Site 8101
Teva Investigational Site 5801
Teva Investigational Site 3134
Teva Investigational Site 3143
Teva Investigational Site 3525
Teva Investigational Site 5319
Teva Investigational Site 1134
Teva Investigational Site 3040
Teva Investigational Site 3301
Teva Investigational Site 3236
Teva Investigational Site 5417
Teva Investigational Site 3237
Teva Investigational Site 3250
Teva Investigational Site 8031
Teva Investigational Site 1094
Teva Investigational Site 3246
Teva Investigational Site 4205
Teva Investigational Site 1083
Teva Investigational Site 3424
Teva Investigational Site 1101
Teva Investigational Site 3810
Teva Investigational Site 5317
Teva Investigational Site 1131
Teva Investigational Site 5322
Teva Investigational Site 1076
Teva Investigational Site 5416
Teva Investigational Site 3529
Teva Investigational Site 3244
Teva Investigational Site 5315
Teva Investigational Site 5023
Teva Investigational Site 3243
Teva Investigational Site 5704
Teva Investigational Site 8034
Teva Investigational Site 3139
Teva Investigational Site 3249
Teva Investigational Site 5802
Teva Investigational Site 6100
Teva Investigational Site 1084
Teva Investigational Site 5900
Teva Investigational Site 5604
Teva Investigational Site 3242
Teva Investigational Site 3425
Teva Investigational Site 3422
Teva Investigational Site 1126
Teva Investigational Site 3038
Teva Investigational Site 3136
Teva Investigational Site 8100
Teva Investigational Site 3041
Teva Investigational Site 5804
Teva Investigational Site 8032
Teva Investigational Site 5028
Teva Investigational Site 5325
Teva Investigational Site 1130
Teva Investigational Site 3045
Teva Investigational Site 4206
Teva Investigational Site 6102
Teva Investigational Site 5210
Teva Investigational Site 3528
Teva Investigational Site 5904
Teva Investigational Site 5902
Teva Investigational Site 3811
Teva Investigational Site 5031
Teva Investigational Site 5803
Teva Investigational Site 3245
Teva Investigational Site 3302
Teva Investigational Site 3239
Teva Investigational Site 5208
Teva Investigational Site 1132
Teva Investigational Site 1082


title: Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma

summary: This is a Phase II, non-randomized, open-label, single-arm trial that will be conducted at up to 50 sites in North America, Europe and Australia. This study is designed to assess objective response (OR) [complete response (CR) or partial response (PR)] in subjects with cutaneous manifestations of CTCL with a requirement for maintenance of such objective response for at least 28 days in subjects with stage IIB, III, and IVA CTCL. Additionally, this study will evaluate the safety and tolerability of CTCL subjects Stages IB, IIA, IIB, III, or IVA treated with oral forodesine.

ReferenceCitation: Dummer R, Duvic M, Scarisbrick J, Olsen EA, Rozati S, Eggmann N, Goldinger SM, Hutchinson K, Geskin L, Illidge TM, Giuliano E, Elder J, Kim YH. Final results of a multicenter phase II study of the purine nucleoside phosphorylase (PNP) inhibitor forodesine in patients with advanced cutaneous T-cell lymphomas (CTCL) (Mycosis fungoides and Sézary syndrome). Ann Oncol. 2014 Sep;25(9):1807-1812. doi: 10.1093/annonc/mdu231. Epub 2014 Jun 19.

family: Dummer

full_name: R. Dummer

given: R.

family: Duvic

full_name: M. Duvic

family: Scarisbrick

full_name: J. Scarisbrick

given: J.

family: Olsen

full_name: E.A. Olsen

family: Rozati

full_name: S. Rozati

given: S.

family: Eggmann

full_name: N. Eggmann

family: Goldinger

full_name: S.M. Goldinger

family: Hutchinson

full_name: K. Hutchinson

given: K.

family: Geskin

full_name: L. Geskin

family: Illidge

full_name: T.M. Illidge

family: Giuliano

full_name: E. Giuliano

family: Elder

full_name: J. Elder

family: Kim

full_name: Y.H. Kim

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Final results of a multicenter phase II study of the purine nucleoside phosphorylase (PNP) inhibitor forodesine in patients with advanced cutaneous t-cell lymphomas (CTCL) (Mycosis fungoides and Sézary syndrome)

lead_sponsor: BioCryst Pharmaceuticals

location_country:
Italy
Austria
Switzerland
Germany
Finland
France
Australia
Spain
United States
United Kingdom

location_facility: University of Alabama at Birmingham, Comprehensive Cancer Ctr

location_facility: Wake Forest University Health Sceinces, Dept. of Dermatology

location_facility: Washington University School of Medicine

location_facility: M.D. Anderson Cancer Center - Dermatology

location_facility: University of Wisconsin-Madison, Dept of Dermatology

location_facility: Hospital at the University of Pennsylvania

location_facility: University Hospitals Case Medical Center, Dept. of Dermatology

location_facility: Hillman Cancer Ctr., University of Pittsburgh

location_facility: Klinik fur Dermatologie, Venerologie und Allergologie

location_facility: LSU Health Sciences Center, Feist-Weiller Cancer Center


title: A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease

summary: This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis.

ipd_sharing: No

lead_sponsor: ACADIA Pharmaceuticals Inc.

location_country:
India
France
Bulgaria
Russian Federation
United States
United Kingdom
Ukraine


title: A Double-blind, Randomized, Placebo-controlled Study to Investigate Chronic Intermittent-pulse-therapy of Moxifloxacin as a Prevention of Acute in Exacerbation Out-patients With Chronic Bronchitis.

summary: Moxifloxacin, is being tested at approximately 60 study centres in 15 countries to determine if this drug, when taken periodically in addition to the patients normal treatment, is effective at reducing the number of flare-ups of chronic bronchitis he has. Approximately 1132 subjects will participate, and it is expected that the study will run for 2 years in order to reach that goal. The patients individual involvement in the study will be 17 months. Moxifloxacin will be compared to a placebo drug (no active ingredients). The study medication (moxifloxacin or placebo) will be taken in addition to the patients normal medication for chronic bronchitis. In addition to the first clinic visit, called a screening visit, the patient will be required to come back to the clinic for ten more study visits, every 8 weeks. At the first visit the study co-ordinator will provide him with the dates for all the visits. Over a period of 48 weeks the patient will return to the clinic on 6 occasions where he will receive the study medication which he will take for five days, in addition to his normal treatment for chronic bronchitis. After this time the patient will enter a follow up period for 24 weeks, where he will come to the clinic for assessments and continue to take his normal medication but not receive the study drug. A complete medical history will be taken at the first visit, including the patients past and current smoking habit. A breath test will be performed to assess how well his lungs are functioning. In addition, he will also be asked to provide a sputum sample for a microbiological examination to identify any bacteria present in the sample. The patient must be able to provide a sputum sample at the screening visit. If the patient meets all the inclusion / exclusion criteria for the study, he will be allocated randomly to one of the following treatment groups at the second visit.- Treatment group 1: Receives moxifloxacin orally once daily for five days.- Treatment group 2: Receives a matching placebo once daily for five days.In between each visit (four weeks after your clinic visit), the study site co-ordinator will contact the patient to check on his well being. If the patient or the doctor decides to stop the patients participation in the trial for any reason, the patient will be required to return to the clinic for a physical examination, take a breath test, provide a sputum sample (if possible) and have a blood sample taken.

primary_purpose: Prevention

ReferenceCitation: Sethi S, Jones PW, Theron MS, Miravitlles M, Rubinstein E, Wedzicha JA, Wilson R; PULSE Study group. Pulsed moxifloxacin for the prevention of exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial. Respir Res. 2010 Jan 28;11:10. doi: 10.1186/1465-9921-11-10. Erratum in: Respir Res. 2010;11:88.

family: Sethi

full_name: Sanjay Sethi

given: Sanjay

family: Jones

full_name: Paul W Jones

given: Paul W

family: Theron

full_name: Marlize Schmitt Theron

given: Marlize Schmitt

family: Miravitlles

full_name: Marc Miravitlles

given: Marc

family: Rubinstein

full_name: Ethan Rubinstein

given: Ethan

family: Wedzicha

full_name: Jadwiga A Wedzicha

given: Jadwiga A

family: Wilson

full_name: Robert Wilson

given: Robert

currency_apc_doaj: GBP

journal_name: Respiratory Research

license: cc-by

license_normalized: cc-by

repository_institution: St George's University of London - St George's Online Research Archive

repository_institution: University of Manitoba - Mspace

lead_sponsor: Bayer

location_country:
Italy
Brazil
Chile
South Africa
Mexico
Germany
Andorra
France
Greece
Israel
Ireland
Argentina
Spain
United States
United Kingdom


status: Terminated

lead_sponsor: Novo Nordisk A/S

location_country: Austria India Mexico France Bulgaria Poland Israel Argentina Belgium Turkey Canada

acronym: iINHALE 7

type: EudraCT Number

source: euctr

title: Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes

summary: This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

status_simplified: Unknown


ReferenceType: result

ReferenceCitation: Strojek K, Bebakar WM, Khutsoane DT, Pesic M, Smahelová A, Thomsen HF, Kalra S. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Curr Med Res Opin. 2009 Dec;25(12):2887-94. doi: 10.1185/03007990903354674.

name: Department of Internal Diseases Diabetology and Nephrology, Silesian Medical University, Zabrze, Poland

family: Strojek

full_name: Krzysztof Strojek

given: Krzysztof

name: School of Medical Sciences, University Sains Malaysia, Kelantan, Malaysia

family: Bebakar

full_name: Wan M.W. Bebakar

given: Wan M.W.

family: Khutsoane

full_name: Duma T. Khutsoane

given: Duma T.

name: Clinical Centre Nis, Endocrinology, Diabetes and Metabolic Disorders Clinic, Nis, Serbia

family: Pesic

full_name: Milica Pesic

given: Milica

name: Department of Metabolic Care and Gerontology, University Hospital, Charles University, Hradec Kralove, Czech Republic

family: Šmahelová

full_name: Alena Šmahelová

given: Alena

family: Thomsen

full_name: Henrik F. Thomsen

given: Henrik F.

name: Bharti Research Institute of Diabetes & Endocrinology, Karnal, India

family: Kalra

full_name: Sanjay Kalra

journal_name: Current Medical Research and Opinion

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Kalra S, Plata-Que T, Kumar D, Mumtaz M, Søndergaard F, Kozlovski P, Bebakar WM. Initiation with once-daily BIAsp 30 results in superior outcome compared to insulin glargine in Asians with type 2 diabetes inadequately controlled by oral anti-diabetic drugs. Diabetes Res Clin Pract. 2010 Jun;88(3):282-8. doi: 10.1016/j.diabres.2010.03.004. Epub 2010 Apr 2.

family: Plata-Que

full_name: Teresa Plata-Que

given: Teresa

family: Kumar

full_name: Dileep Kumar

given: Dileep

family: Mumtaz

full_name: Malik Mumtaz

given: Malik

family: Søndergaard

full_name: Flemming Søndergaard

given: Flemming

family: Kozlovski

full_name: Plamen Kozlovski

given: Plamen

full_name: Wan Mohamad Wan Bebakar

given: Wan Mohamad Wan

journal_name: Diabetes Research and Clinical Practice

location_country:
Austria
South Africa
Sweden
Former Serbia and Montenegro
India
Mexico
Netherlands
Philippines
France
Malaysia
Poland
Romania
Argentina
Spain
Czech Republic

title: A Multi-national, Open-labelled, Randomised, Parallel Group, 4 Week run-in and 26 Weeks Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin naïve Subjects With Type 2 Diabetes

summary:
This trial is conducted in Africa, Asia, Europe, Oceania and South America.

This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.


title: European Epidemiologic COHORT Study: A Prospective Epidemiologic COHORT Study Of Ocular Safety In Patients Receiving Macugen Injections For Neovascular Age-Related Macular Degeneration (AMD) In Europe

summary: The study will provide additional safety data for specific safety events in persons receiving intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is interested in obtaining additional safety information when Macugen is used in real world settings by practitioners in Europe treating patients with neovascular (wet) age-related macular degeneration (AMD). The study will provide information about physician practice patterns and characteristics of patients treated with Macugen.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Pfizer

location_country:
Italy
Sweden
Cyprus
France
Poland
Greece
Slovakia
Ireland
Belgium
Spain
Denmark
Germany
Czech Republic


title: A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD), Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery (The ADVANCE - 2 Study)

summary: The purpose of this study is to learn whether apixaban prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare the efficacy of apixaban with that of enoxaparin (Lovenox®) in the prevention of these clots. The safety of apixaban will also be studied.

ReferenceCitation: Pineo GF, Gallus AS, Raskob GE, Chen D, Ramirez LM, Ramacciotti E, Lassen MR, Wang L. Apixaban after hip or knee arthroplasty versus enoxaparin: efficacy and safety in key clinical subgroups. J Thromb Haemost. 2013 Mar;11(3):444-51. doi: 10.1111/jth.12109.

family: PINEO

full_name: G. F. PINEO

given: G. F.

family: GALLUS

full_name: A. S. GALLUS

given: A. S.

family: RASKOB

full_name: G. E. RASKOB

given: G. E.

family: CHEN

full_name: D. CHEN

given: D.

family: RAMIREZ

full_name: L.-M. RAMIREZ

family: RAMACCIOTTI

full_name: E. RAMACCIOTTI

given: E.

family: LASSEN

full_name: M. R. LASSEN

given: M. R.

family: WANG

full_name: L. WANG

given: L.

journal_name: Journal of Thrombosis and Haemostasis

evidence: open (via free pdf)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P; ADVANCE-2 investigators. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet. 2010 Mar 6;375(9717):807-15. doi: 10.1016/S0140-6736(09)62125-5.

family: Lassen

full_name: Michael Rud Lassen

given: Michael Rud

family: Raskob

full_name: Gary E Raskob

given: Gary E

family: Gallus

full_name: Alexander Gallus

given: Alexander

family: Pineo

full_name: Graham Pineo

given: Graham

family: Chen

full_name: Dalei Chen

given: Dalei

family: Hornick

full_name: Philip Hornick

given: Philip

journal_name: The Lancet

lead_sponsor: Bristol-Myers Squibb

location_country:
Malaysia
Belgium
Russian Federation
Denmark
Czech Republic
Ukraine
India
France
Poland
Norway
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Philippines
Singapore
Hungary
China
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain


title: A Randomized, Double-blind Study of the Effect of Treatment Duration and Dose of PEGASYS on HBeAg Seroconversion and Safety in Patients With HBeAg Positive Chronic Hepatitis B.

summary: This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms subcutaneous (sc) weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24 weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

ReferenceCitation: Liaw YF, Jia JD, Chan HL, Han KH, Tanwandee T, Chuang WL, Tan DM, Chen XY, Gane E, Piratvisuth T, Chen L, Xie Q, Sung JJ, Wat C, Bernaards C, Cui Y, Marcellin P. Shorter durations and lower doses of peginterferon alfa-2a are associated with inferior hepatitis B e antigen seroconversion rates in hepatitis B virus genotypes B or C. Hepatology. 2011 Nov;54(5):1591-9. doi: 10.1002/hep.24555.

family: Liaw

full_name: Y.-F. Liaw

family: Jia

full_name: J.-D. Jia

family: Chan

full_name: H.L.Y. Chan

family: Han

full_name: K.H. Han

family: Tanwandee

full_name: T. Tanwandee

given: T.

family: Chuang

full_name: W.L. Chuang

family: Tan

full_name: D.M. Tan

full_name: X.Y. Chen

family: Gane

full_name: E. Gane

family: Piratvisuth

full_name: T. Piratvisuth

full_name: L. Chen

family: Xie

full_name: Q. Xie

given: Q.

family: Sung

full_name: J.J.Y. Sung

family: Wat

full_name: C. Wat

given: C.

family: Bernaards

full_name: C. Bernaards

family: Cui

full_name: Y. Cui

given: Y.

family: Marcellin

full_name: P. Marcellin

given: P.

journal_name: Hepatology

lead_sponsor: Hoffmann-La Roche

location_country:
Brazil
Hong Kong
Germany
France
Thailand
Singapore
Australia
Russian Federation
New Zealand
China
United States
Korea, Republic of
Taiwan


type: Other Identifier

title: A Phase II, Open-Label Trial Using Velcade for ReTreatment of Multiple Myeloma Subjects Following an Initial Response to Velcade

summary: The purpose of this study is to evaluate the safety and efficacy of bortezomib in participants with multiple myeloma who have previously responded to a bortezomib based therapy.

lead_sponsor: Janssen-Cilag International NV

location_country: Luxembourg Austria Spain France Greece Belgium Portugal Germany


ReferenceCitation: Simon J, Nachtigall L, Ulrich LG, Eugster-Hausmann M, Gut R. Endometrial safety of ultra-low-dose estradiol vaginal tablets. Obstet Gynecol. 2010 Oct;116(4):876-883. doi: 10.1097/AOG.0b013e3181f386bb.

family: Simon

full_name: James Simon

given: James

family: Nachtigall

full_name: Lila Nachtigall

given: Lila

family: Ulrich

full_name: Lian G. Ulrich

given: Lian G.

family: Eugster-Hausmann

full_name: Michaela Eugster-Hausmann

given: Michaela

family: Gut

full_name: Robert Gut

given: Robert

bso_classification: Biology (fond.)

journal_name: Obstetrics & Gynecology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Endometrial Safety of Ultra-Low-Dose Estradiol Vaginal Tablets

ReferenceCitation: Simon J, Nachtigall L, Gut R, Lang E, Archer DF, Utian W. Effective treatment of vaginal atrophy with an ultra-low-dose estradiol vaginal tablet. Obstet Gynecol. 2008 Nov;112(5):1053-60. doi: 10.1097/AOG.0b013e31818aa7c3. Erratum in: Obstet Gynecol. 2008 Dec;112(6):1392.

family: Lang

full_name: Eva Lang

given: Eva

family: Archer

full_name: David F. Archer

given: David F.

family: Utian

full_name: Wulf Utian

given: Wulf

title: Effective Treatment of Vaginal Atrophy With an Ultra–Low-Dose Estradiol Vaginal Tablet

location_country:
Sweden
Finland
France
Norway
Hungary
Denmark
Czech Republic

title: A 12 Month, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms

summary: This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.


title: A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination With Lapatinib (GW572016) Compared to Pazopanib Monotherapy and Lapatinib Monotherapy in Subjects With FIGO Stage IVB or Recurrent or Persistent Cervical Cancer With Zero or One Prior Chemotherapy Regimen

summary: This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone or pazopanib alone in subjects with metastatic cervical cancer

ReferenceCitation: Monk BJ, Mas Lopez L, Zarba JJ, Oaknin A, Tarpin C, Termrungruanglert W, Alber JA, Ding J, Stutts MW, Pandite LN. Phase II, open-label study of pazopanib or lapatinib monotherapy compared with pazopanib plus lapatinib combination therapy in patients with advanced and recurrent cervical cancer. J Clin Oncol. 2010 Aug 1;28(22):3562-9. doi: 10.1200/JCO.2009.26.9571. Epub 2010 Jul 6.

name: From the University of California Irvine Medical Center, Orange, CA; Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru; Centro Medico San Roque, Tucuman, Argentina; Vall d'Hebron University Hospital, Barcelona, Spain; Centre Regional de Lutte Contre le Cancer, Marseille, France; Chulalongkorn University, Bangkok, Thailand; and GlaxoSmithKline, Collegeville, PA.

family: Monk

full_name: Bradley J. Monk

given: Bradley J.

family: Mas Lopez

full_name: Luis Mas Lopez

given: Luis

family: Zarba

full_name: Juan J. Zarba

given: Juan J.

family: Oaknin

full_name: Ana Oaknin

given: Ana

family: Tarpin

full_name: Carole Tarpin

given: Carole

family: Termrungruanglert

full_name: Wichai Termrungruanglert

given: Wichai

family: Alber

full_name: Jacquelyn A. Alber

given: Jacquelyn A.

family: Ding

full_name: Jie Ding

given: Jie

family: Stutts

full_name: Melissa W. Stutts

given: Melissa W.

family: Pandite

full_name: Lini N. Pandite

given: Lini N.

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Phase II, Open-Label Study of Pazopanib or Lapatinib Monotherapy Compared With Pazopanib Plus Lapatinib Combination Therapy in Patients With Advanced and Recurrent Cervical Cancer

ReferenceCitation: Monk BJ, Pandite LN. Survival data from a phase II, open-label study of pazopanib or lapatinib monotherapy in patients with advanced and recurrent cervical cancer. J Clin Oncol. 2011 Dec 20;29(36):4845. doi: 10.1200/JCO.2011.38.8777. Epub 2011 Nov 14.

name: Creighton University School of Medicine at St Joseph's Hospital and Medical Center, Phoenix, AZ

name: GlaxoSmithKline, Research Triangle Park, NC

title: Survival Data From a Phase II, Open-Label Study of Pazopanib or Lapatinib Monotherapy in Patients With Advanced and Recurrent Cervical Cancer

ReferenceCitation: de Jonge MJ, Hamberg P, Verweij J, Savage S, Suttle AB, Hodge J, Arumugham T, Pandite LN, Hurwitz HI. Phase I and pharmacokinetic study of pazopanib and lapatinib combination therapy in patients with advanced solid tumors. Invest New Drugs. 2013 Jun;31(3):751-9. doi: 10.1007/s10637-012-9885-8. Epub 2012 Oct 6.

family: de Jonge

full_name: Maja J. A. de Jonge

given: Maja J. A.

family: Hamberg

full_name: Paul Hamberg

given: Paul

family: Verweij

full_name: Jaap Verweij

given: Jaap

family: Savage

full_name: Shawna Savage

given: Shawna

family: Suttle

full_name: A. Benjamin Suttle

given: A. Benjamin

family: Hodge

full_name: Jeffrey Hodge

given: Jeffrey

family: Arumugham

full_name: Thangam Arumugham

given: Thangam

family: Hurwitz

location_country:
Italy
United States
India
Mexico
Germany
France
Thailand
Ireland
Belgium
Argentina
Spain
Estonia
Canada


title: A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

summary: The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.

ReferenceCitation: Spaeth M, Russell IJ, Perrot S, Alvarez-Horine S, Guinta D, Wang YG, Bennett R. Durability of Response in a 38-Week Open-Label Study of Sodium Oxybate in Patients With Fibromyalgia [ACR/ARHP abstract 2356]. Arthritis Rheum. 2010;62(suppl 10):97.

ReferenceCitation: Spaeth M, Alegre C, Perrot S, Wang Y, Guinta DR, Alvarez-Horine S, Russell I; Sodium Oxybate Fibromyalgia Study Group. Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia. Arthritis Res Ther. 2013 Nov 11;15(6):R185. doi: 10.1186/ar4375.

family: Spaeth

full_name: Michael Spaeth

given: Michael

family: Alegre

full_name: Cayetano Alegre

given: Cayetano

family: Perrot

full_name: Serge Perrot

given: Serge

family: Wang

full_name: Youyu Wang

given: Youyu

family: Guinta

full_name: Diane R Guinta

given: Diane R

family: Alvarez-Horine

full_name: Sarah Alvarez-Horine

given: Sarah

family: Russell

full_name: Irwin Russell

given: Irwin

name: the Sodium Oxybate Fibromyalgia Study Group

journal_name: Arthritis Research & Therapy

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

repository_normalized: HAL

repositories:
HAL
PubMed Central

lead_sponsor: Jazz Pharmaceuticals

location_country:
Italy
United States
Netherlands
France
Spain
Germany
United Kingdom

location_facility: Professional Clinical Research, Inc. at Crystal Lake Health Center

location_facility: Hill Top Physicians Inc./Hightop Medical Research Center

location_facility: Central Kentucky Research Associates, Inc.

location_facility: Anderson & Collins Clinical Research, Inc.

location_facility: Azienda Ospedaliera universitaria Pisana-Ospedale Santa Chiara

location_facility: Praxis fur Innere Medizin und Rheumatologie

location_facility: Clinical Research Group of St. Petersburg, Inc

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Fibromyalgia Treatment Centers of America

location_facility: Hopital Hotel Dieu service de medicine interne

location_facility: Hopital Claude Huriez Service de medecine interne

location_facility: Professional Clinical Research at Crystal Lake Health Center

location_facility: Gemeinschaftspraxis fur anasthesie und spezielle Schmerztherapie

location_facility: Centre Catherine de Sienne unite d evaluation et de traitement de la douleur


title: A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery (The Advance-3 Study Apixaban Dosed Orally Versus Anticoagulation With Injectable Enoxaparin to Prevent Venous Thromboembolism)

summary: The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in preventing these clots. The safety of apixaban will also be studied

family: PINEO

full_name: G. F. PINEO

given: G. F.

family: GALLUS

full_name: A. S. GALLUS

given: A. S.

family: RASKOB

full_name: G. E. RASKOB

given: G. E.

family: CHEN

full_name: D. CHEN

given: D.

family: RAMIREZ

full_name: L.-M. RAMIREZ

family: RAMACCIOTTI

full_name: E. RAMACCIOTTI

given: E.

family: LASSEN

full_name: M. R. LASSEN

given: M. R.

family: WANG

full_name: L. WANG

given: L.

title: Apixaban after hip or knee arthroplasty versus enoxaparin: efficacy and safety in key clinical subgroups

ReferenceCitation: Lassen MR, Gallus A, Raskob GE, Pineo G, Chen D, Ramirez LM; ADVANCE-3 Investigators. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med. 2010 Dec 23;363(26):2487-98. doi: 10.1056/NEJMoa1006885.

family: Lassen

full_name: Michael Rud Lassen

given: Michael Rud

family: Gallus

full_name: Alexander Gallus

given: Alexander

family: Raskob

full_name: Gary E. Raskob

given: Gary E.

family: Pineo

full_name: Graham Pineo

given: Graham

family: Chen

full_name: Dalei Chen

given: Dalei

family: Ramirez

full_name: Luz Margarita Ramirez

given: Luz Margarita

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Apixaban versus Enoxaparin for Thromboprophylaxis after Hip Replacement

location_country:
Romania
Belgium
Australia
Russian Federation
Denmark
Ukraine
India
France
Poland
Norway
Argentina
Canada
Sweden
Hungary
China
United States
United Kingdom
Germany
Mexico
Israel
Spain

location_facility: Advanced Orthopedic And Sports Medicine Specilists


title: A Ten-week, Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled, Paralleled-Group, Flexible-Dose Study Evaluating the Efficacy, Safety and Tolerability of GSK372475 or Paroxetine Compared to Placebo in Adult Subjects Diagnosed With Major Depressive Disorder

summary: To evaluate the efficacy, safety and tolerability of GSK372475 compared with placebo in the treatment of outpatients subjects with major depressive disorder to exhibit decreased pleasure, interest and energy.

ReferenceType: background

ReferenceCitation: Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell J, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. Results of Two Double-Blind, Placebo- and Active-Controlled Studies of GSK372475, a Triple Monoamine Reuptake Inhibitor, in the Treatment of Major Depressive Disorder. [J Psychopharmacol EPublication ahead of print. DOI 10.1177/0269881111424931]. 2011;

ReferenceCitation: Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell JG, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. Efficacy, safety, and tolerability of a triple reuptake inhibitor GSK372475 in the treatment of patients with major depressive disorder: two randomized, placebo- and active-controlled clinical trials. J Psychopharmacol. 2012 May;26(5):653-62. doi: 10.1177/0269881111424931. Epub 2011 Nov 2.

name: Neurosciences Discovery Medicine, Research Triangle Park, NC, USA and Verona, Italy

family: Learned

full_name: Susan Learned

given: Susan

family: Graff

full_name: Ole Graff

given: Ole

name: Neurosciences Medicines Development Center, Research Triangle Park, NC, USA and Harlow, UK

family: Roychowdhury

full_name: Suraja Roychowdhury

given: Suraja

name: Discovery Biometrics, GlaxoSmithKline, Harlow, UK

family: Moate

full_name: Rachel Moate

given: Rachel

name: Department of Psychiatry, Duke University, Durham, NC, USA

family: Krishnan

full_name: K Ranga Krishnan

given: K Ranga

family: Archer

full_name: Graeme Archer

given: Graeme

family: Modell

full_name: Jack G Modell

given: Jack G

family: Alexander

full_name: Robert Alexander

given: Robert

family: Zamuner

full_name: Stefano Zamuner

given: Stefano

family: Lavergne

full_name: Agnes Lavergne

given: Agnes

family: Evoniuk

full_name: Gary Evoniuk

given: Gary

family: Ratti

full_name: Emiliangelo Ratti

given: Emiliangelo

journal_name: Journal of Psychopharmacology

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Chile
India
Costa Rica
Germany
Croatia
Bulgaria
France
Poland
Canada


title: A Long-term, Open-label Follow-up Study Of Tofacitinib (Cp-690,550) For Treatment Of Rheumatoid Arthritis

summary:
The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study only after participating in another "qualifying" study of CP-690,550

A sub-study will be conducted within the A3921024 study, this study will evaluate the immune response to pneumococcal and influenza vaccines in patients receiving CP-690,550

ReferenceCitation: Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3). pii: e001395. doi: 10.1136/rmdopen-2020-001395.

family: Cohen

full_name: Stanley B Cohen

given: Stanley B

family: Tanaka

full_name: Yoshiya Tanaka

given: Yoshiya

family: Mariette

full_name: Xavier Mariette

given: Xavier

family: Curtis

full_name: Jeffrey R Curtis

given: Jeffrey R

family: Lee

full_name: Eun Bong Lee

given: Eun Bong

family: Nash

full_name: Peter Nash

given: Peter

family: Winthrop

full_name: Kevin L Winthrop

given: Kevin L

family: Charles-Schoeman

full_name: Christina Charles-Schoeman

given: Christina

family: Wang

full_name: Lisy Wang

given: Lisy

full_name: Connie Chen

given: Connie

family: Kwok

full_name: Kenneth Kwok

given: Kenneth

family: Biswas

full_name: Pinaki Biswas

given: Pinaki

family: Shapiro

full_name: Andrea Shapiro

given: Andrea

family: Madsen

full_name: Ann Madsen

given: Ann

family: Wollenhaupt

full_name: Jürgen Wollenhaupt

given: Jürgen

journal_name: RMD Open

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

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

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: van der Heijde D, Landewé RBM, Wollenhaupt J, Strengholt S, Terry K, Kwok K, Wang L, Cohen S. Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies. Rheumatology (Oxford). 2021 Apr 6;60(4):1708-1716. doi: 10.1093/rheumatology/keaa476.

name: Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands

family: van der Heijde

full_name: Désirée van der Heijde

given: Désirée

name: Amsterdam Rheumatology & Immunology Center, Amsterdam University Medical Centers, Amsterdam, The Netherlands

name: Department of Rheumatology, Zuyderland Medical Center, Heerlen, The Netherlands

name: Rheumatologie im Struenseehaus, Hamburg, Germany

name: Pfizer Inc, Capelle aan den IJssel, The Netherlands

name: Department of Rheumatology, Metroplex Clinical Research Center, Dallas, TX, USA

name: Department of Rheumatology, University of Texas Southwestern Medical Center, Dallas, TX, USA

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: Kaine J, Tesser J, Takiya L, DeMasi R, Wang L, Snyder M, Soma K, Fan H, Bandi V, Wollenhaupt J. Re-establishment of efficacy of tofacitinib, an oral JAK inhibitor, after temporary discontinuation in patients with rheumatoid arthritis. Clin Rheumatol. 2020 Jul;39(7):2127-2137. doi: 10.1007/s10067-020-04956-1. Epub 2020 Feb 12.

ReferenceCitation: Wollenhaupt J, Lee EB, Curtis JR, Silverfield J, Terry K, Soma K, Mojcik C, DeMasi R, Strengholt S, Kwok K, Lazariciu I, Wang L, Cohen S. Safety and efficacy of tofacitinib for up to 9.5 years in the treatment of rheumatoid arthritis: final results of a global, open-label, long-term extension study. Arthritis Res Ther. 2019 Apr 5;21(1):89. doi: 10.1186/s13075-019-1866-2.

repository_institution: Seoul National University - Seoul National University Open Repository

repositories_institution: Seoul National University - Seoul National University Open Repository

ReferenceCitation: Li ZG, Liu Y, Xu HJ, Chen ZW, Bao CD, Gu JR, Zhao DB, An Y, Hwang LJ, Wang L, Kremer J, Wu QZ. Efficacy and Safety of Tofacitinib in Chinese Patients with Rheumatoid Arthritis. Chin Med J (Engl). 2018 Nov 20;131(22):2683-2692. doi: 10.4103/0366-6999.245157.

ReferenceCitation: Hall S, Nash P, Rischmueller M, Bossingham D, Bird P, Cook N, Witcombe D, Soma K, Kwok K, Thirunavukkarasu K. Tofacitinib, an Oral Janus Kinase Inhibitor: Pooled Efficacy and Safety Analyses in an Australian Rheumatoid Arthritis Population. Rheumatol Ther. 2018 Dec;5(2):383-401. doi: 10.1007/s40744-018-0118-2. Epub 2018 Jun 11.

ReferenceCitation: Fleischmann R, Wollenhaupt J, Cohen S, Wang L, Fan H, Bandi V, Andrews J, Takiya L, Bananis E, Weinblatt ME. Effect of Discontinuation or Initiation of Methotrexate or Glucocorticoids on Tofacitinib Efficacy in Patients with Rheumatoid Arthritis: A Post Hoc Analysis. Rheumatol Ther. 2018 Jun;5(1):203-214. doi: 10.1007/s40744-018-0093-7. Epub 2018 Feb 7.

ReferenceCitation: Mariette X, Chen C, Biswas P, Kwok K, Boy MG. Lymphoma in the Tofacitinib Rheumatoid Arthritis Clinical Development Program. Arthritis Care Res (Hoboken). 2018 May;70(5):685-694. doi: 10.1002/acr.23421. Epub 2018 Apr 2.

name: Université Paris-Sud, Assistance publique-Hôpitaux de Paris; Hôpitaux Universitaires Paris-Sud; INSERM U1184; Le Kremlin Bicêtre France

ReferenceCitation: Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Genovese MC, van Vollenhoven RF, Wilkinson B, Wang L, Zwillich SH, Gruben D, Biswas P, Riese R, Takiya L, Jones TV. Switching from adalimumab to tofacitinib in the treatment of patients with rheumatoid arthritis. Arthritis Res Ther. 2016 Jun 23;18:145. doi: 10.1186/s13075-016-1049-3.

ReferenceCitation: Winthrop KL, Silverfield J, Racewicz A, Neal J, Lee EB, Hrycaj P, Gomez-Reino J, Soma K, Mebus C, Wilkinson B, Hodge J, Fan H, Wang T, Bingham CO 3rd. The effect of tofacitinib on pneumococcal and influenza vaccine responses in rheumatoid arthritis. Ann Rheum Dis. 2016 Apr;75(4):687-95. doi: 10.1136/annrheumdis-2014-207191. Epub 2015 Mar 20.

ReferenceCitation: Boyle DL, Soma K, Hodge J, Kavanaugh A, Mandel D, Mease P, Shurmur R, Singhal AK, Wei N, Rosengren S, Kaplan I, Krishnaswami S, Luo Z, Bradley J, Firestein GS. The JAK inhibitor tofacitinib suppresses synovial JAK1-STAT signalling in rheumatoid arthritis. Ann Rheum Dis. 2015 Jun;74(6):1311-6. doi: 10.1136/annrheumdis-2014-206028. Epub 2014 Nov 14.

repository_institution: California Digital Library - eScholarship

repository_normalized: California Digital Library - eScholarship

repositories: California Digital Library - eScholarship

repositories_institution: California Digital Library - eScholarship

location_country:
Peru
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
India
Costa Rica
Croatia
France
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
Colombia
Chile
Sweden
Philippines
Bulgaria
Hungary
Ireland
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Brazil
Mexico
Dominican Republic
Czechia
New Zealand
Spain
Turkey

location_facility: Arizona Arthritis & Rheumatology Associates, P.C.

location_facility: Rheumatology Research Unit Sunshine Coast

location_facility: Centro Integral en Reumatologia, SA de CV

location_facility: Centrum Badan Klinicznych s.c. Wieslawa Porawska, Lukasz Porawski

location_facility: St. Petersburg State Institution of Healthcare Consultative-diagnostic Center #85

location_facility: Louisiana State University Health Sciences Center

location_facility: Southeastern Integrated Medical PL d/b/a Florida Medical Research Institute

location_facility: Centro de Reumatologia y Osteoporosis, Cartago

location_facility: ARTHROMED, s. r. o. Revmatologicka ambulance

location_facility: Hospital Universitario Doctor Jose Eleuterio Gonzalez

location_facility: "Consultative Diagnostic Rheumatology Center ""Healthy Joints"", LLC"

location_facility: Division of Allergy-Immunology-Rheumatology, Department of Medicine, Faculty of Medicine

location_facility: Reumatologicka ambulancia, Poliklinika Ruzinov

location_facility: Krishna Institute of Medical Sciences Ltd

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: The Canterbury Geriatric Medical Research Trust, c/- The Princess Margaret Hospital

location_facility: Daegu Catholic University Medical Center

location_facility: De La Salle University Health Sciences Campus Clinical Epidemiology Unit

location_facility: Asheville Rheumatology & Osteoporosis Research Associates, P.A.

location_facility: DKTs "Sveta Anna", Sofia / Diagnostic Consultative Center "Sveta Anna"

location_facility: CHI St. Vincent Medical Group Hot Springs

location_facility: Clinic of Cardiology and Rheumatology Military Medical Academy

location_facility: State Healthcare Institution Regional Clinical Hospital

location_facility: Reumatologicka ambulancia, MUDr. Zuzana Cizmarikova, s.r.o.

location_facility: Asheville Rheumatology & Osteoporosis Research Associates, PA

location_facility: Clinica de Enfermedades Cronicas y Procedimientos Especiales SC

location_facility: Clinical Hospital #122 named after L.G. Sokolov of the Federal Medical-Biological Agency

location_facility: OMI - Organización Médica de Investigación

location_facility: University of California San Diego Center for Innovative Therapy

location_facility: Gangnam Severance Hospital-Yonsei University Health System

location_facility: Dr. William G. Bensen Medicine Professional Corporation

location_facility: Schlosspark-Klinik Innere Medizin II, Rheumatologie

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: West Island Rheumatology Research Associates

location_facility: Municipal City Clinical Hospital #4, Policlinic Care

location_facility: Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.

location_facility: Studienambulanz Universitaetsklinikum Erlangen Medizinische Klinik 3

location_facility: University of Southern California (USC) Norris Comprehensive Cancer Center-

location_facility: Rheumatology and Immunology Dept., Renji Hospital Shanghai Jiao Tong University School of Medicine

location_facility: Queen Elizabeth Hospital, Department of Rheumatology

location_facility: Federal North-West Medical Research Centre

location_facility: Arthritis Associates and Osteoporosis Center of Colorado Springs

location_facility: Arthrocare, Arthritis Care & Research, PC

location_facility: Jehangir Clinical Development Centre Pvt. Ltd.

location_facility: Krankenhaus Friedrichstadt, I. Medizinische Klinik

location_facility: University of Southern California (USC) Norris Comprehensive Cancer Center

location_facility: State Educational Institution of Higher Professional Education Ural State Medical Academy of Federal

location_facility: Xiangya Hospital of Centre-south University

location_facility: Centro de Reumatologia y Ortopedia S.A.S.

location_facility: "Multifield Medical Center of Odesa National Medical University ""University Clinic #1"""

location_facility: Universitaetsklinikum Koeln Klinik I fuer Innere Medizin, Haus 16, 1. OG, Raum 1.008

location_facility: DKTs "Sveta Anna" Sofia, Konsultativen kabinet po Revmatologia

location_facility: Hospital Nacional IV Alberto Sabogal Sologuren

location_facility: General Hospital Euromedica "KYANOUS STAVROS"

location_facility: Seoul St. Mary's Hospital-The Catholic University of Korea

location_facility: Charite Campus Mitte, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie

location_facility: Chanre Rheumatology & Immunology Center & Research

location_facility: Asan Medical Center-University of Ulsan College of Medicine

location_facility: Universitair Ziekenhuis Gent - Reumatologie

location_facility: Wirral University Teaching Hospital NHS Foundation Trust-Arrowe Park Hospital

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Inland Rheumatology Clinical Trials, Inc.

location_facility: "ZDROWIE OSTEO-MEDIC" s.c. Lidia I Artur Racewicz, Agnieszka I Jerzy Supronik

location_facility: The Arthritis Program Research Group Inc.

location_facility: Centro de Investigaciones Reumatologicas y Osteologicas -CIRO

location_facility: Instituto Peruano del Hueso y la Articulacion SAC-Privado-Lima/Centro de Investigacion IPHAR

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Ronald Reagan UCLA Medical Center, Drug Information Center

location_facility: University of Perpetual Help Rizal Dalta Medical Center

location_facility: Jacksonville Center for Clinical Research

location_facility: Unidad de Enfermedades Reumaticas y Cronico Degenerativas SC

location_facility: Rheumatology Research Institute of Russian Academy of Medical Sciences

location_facility: Reliant Medical Group, Inc. at Worcester Medical Center

location_facility: Centro de Estudos em Terapias Inovadoras

location_facility: Rheumatology Unit, Department of Internal Medicine, Phramongkutklao Hospital

location_facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

location_facility: Reumatologicka ambulancia, Nestatne zdravotnicke zariadenie

location_facility: Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,

location_facility: AAGS, s.r.o. , nestatne zdravotnicke zariadenie

location_facility: Centro de Investigacion Clinica Especializada, SC

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: "Department of Infectious Diseases & Immunology

location_facility: University of North Texas Health Science Center at Fort Worth

location_facility: Bronson Internal Medicine and Rheumatology

location_facility: Universitaetsklinik Leipzig, Klinik fur Gastroenterologie und Rheumatologie, Sektion Rheumatologie

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)

location_facility: Multifield Medical Center of Odesa National Medical University "University Clinic #1"

location_facility: The Center for Rheumatology and Bone Research

location_facility: Klinikum der Universitaet Muenchen, Campus Innenstadt, Rheuma-Einheit

location_facility: Nestatna reumatologicka ambulancia, MUDr. Pavol Polak s.r.o.

location_facility: CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda

location_facility: Russian State Medical University Moscow Faculty City Clinical Hospital #4

location_facility: IMA Brasil -Instituto de Pesquisa Clinica e Medicina Avancada

location_facility: Centro de Investigacion Clinica de Morelia

location_facility: Professional Research Network of Kansas, LLC

location_facility: Wojewodzki Zespol Reumatologiczny im. dr Jadwigi Titz-Kosko

location_facility: Cincinnati Rheumatic Disease Study Group, Inc.

location_facility: Reumatologicka ambulancia, REUMEX, s.r.o.

location_facility: Clinical Research Center of Cape Cod, Inc.

location_facility: Orszagos Reumatologiai Es Fizioterapias Intezet

location_facility: Fakultni Nemocnice Brno, Interni hematoonkologicka klinika

location_facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie

location_facility: Regional State Budget Institution Of Healthcare

location_facility: St. Luke's Intermountain Research Center

location_facility: State Healthcare Institution Regional Clinical Hospital for War Veterans

location_facility: Arthritis and Rheumatic Disease Specialties

location_facility: A.O.U. Careggi - SOD Medicina Interna 1 e Reumatologia

location_facility: Delaware Arthritis and Osteoporosis Center

location_facility: Arthritis and Rheumatology Consultants, P.A.

location_facility: State Institution Republican Clinical Hospital of the Ministry of Health of Ukraine

location_facility: Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi

location_facility: NOVAPHARM s.r.o -Zeleznicna NaP, Reumatologicka ambulancia

location_facility: Arthritis and Rheumatology of Georgia P.C.

location_facility: Clinic of Rheumatology Multiprofile Hospital for Active treatment Sveti Ivan Rilski

location_facility: Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute

location_facility: Beijing Chaoyang Hospital, Capital University of Medical Science

location_facility: Unidad de Investigacion en Enfermedades Cronico Degenerativas

location_facility: MAV Korhaz es Rendelointezet, Reumatologiai szakrendeles

location_facility: State Establishment "Institute of Gerontology of NAMS of Ukraine n.a. D.F. Chebotareva"

location_facility: St. John's Medical College and Hospital.

location_facility: Crimean Republican Institution "Clinical Territorial Medical Association "University Clinic",

location_facility: Sozialmedizinisches Zentrum Sued - Kaiser Franz Josef Spital

location_facility: Revmatologichen kabinet, DKTs Sveti Pantaleimon OOD

location_facility: Hospital Central Dr Ignacio Morones Prieto Unidad Regional de Reumatologia y Osteoporosis

location_facility: State Healthcare Institution City Hospital # 40 of Administrative Health Resort District

location_facility: Municipal Establishment "City Hospital#7of Zaporizhzhia State Medical University

location_facility: Fakultni Thomayerova nemocnice s poliklinikou

location_facility: Skanes Universitetssjukhus i Malmo Reumamottagningen

location_facility: Chanre Rheumatology and Immunology Center and Research

location_facility: Municipal Establishment of Health Care "Kharkiv City Clinical Hospital #8", Dept. of Rheumatology

location_facility: Arthritis, Rheumatic & Back Disease Associates

location_facility: Hospital Civil. Hospital Regional Universitario Carlos Haya

location_facility: CRIMEAN Republican Institution, "Clinical Hospital n.a. M.O. Semashko"

location_facility: Oklahoma Medical Research Foundation (OMRF)

location_facility: CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda

location_facility: Centro de Diagnostico y Tratamiento Hospital San Borja Arriaran

location_facility: J.W.-Goethe-Universitaetsklinik, Medizinische Klinik II, Abteilung fuer Rheumatologie

location_facility: Cividino Medicine Professional Corporation

location_facility: Arthritis Care and Diagnostic Center, P.A.

location_facility: Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S CIREEM S.A.S

location_facility: Arthritis Research Center, Royal University Hospital

location_facility: Rheumatology Unit, Department of Internal Medicine, Rajavithi Hospital

location_facility: Vinnitsa Regional Clinical Hospital n.a. Pirogov

location_facility: Ltd.Medical Association "Novaya Bolnitsa"

location_facility: Center for Arthritis and Rheumatic Diseases

location_facility: OMI- Organizacion Medica de Investigacion

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Stanford Health Services - Medical Specialty Clinics

location_facility: University Hospital Split, Department for Internal Medicine, Division of Clinical Rheumatology

location_facility: Revmatologichno Otdelenie, MBAL - Plovdiv

location_facility: State Educational Institution of Higher Professional Education

location_facility: Arthritis Research and Care Foundation Centre for Rheumatic Diseases

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: The Third Affiliated Hospital of Sun Yat-Sen University

location_facility: Centro Medico Corpac/Investigaciones en Reumatologia

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Xijing Hospital, The Fourth Military Medical University

location_facility: West Broward Rheumatology Associates, Inc.

location_facility: Saint-Petersburg State Budgetary Healthcare Institution "Clinical Rheumathology Hospital #25"

location_facility: Angeles University Foundation Medical Center

location_facility: Peking University People's Hospital/Rheumatology and Immunology Department

location_facility: Clinica Santa Maria, Seccion Reumatologia

location_facility: Ecclesia, s.r.o Reumatologicka ambulancia

location_facility: ClinicMed Badurski i wspolnicy Spolka Jawna

location_facility: Rheuma-Medicus - Specjalistyczne Centrum Reumatologii i Osteoporozy

location_facility: Regional State Budgetary Healthcare Institution of Tomsk Regional Clinical Hospital

location_facility: Hospital Base Valdivia, Policlinico de Reumatologia

location_facility: The Second Affiliated Hospital of Guangzhou Medical University

location_facility: Investigacion y Biomedica de Chihuahua, SC

location_facility: Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.

location_facility: Rheumatology Associates of North Alabama, PC

location_facility: Arthritis and Osteoporosis Associates, LLP


ReferenceCitation: Marty FM, Ljungman P, Papanicolaou GA, Winston DJ, Chemaly RF, Strasfeld L, Young JA, Rodriguez T, Maertens J, Schmitt M, Einsele H, Ferrant A, Lipton JH, Villano SA, Chen H, Boeckh M; Maribavir 1263-300 Clinical Study Group. Maribavir prophylaxis for prevention of cytomegalovirus disease in recipients of allogeneic stem-cell transplants: a phase 3, double-blind, placebo-controlled, randomised trial. Lancet Infect Dis. 2011 Apr;11(4):284-92. doi: 10.1016/S1473-3099(11)70024-X. Epub 2011 Mar 21. Erratum in: Lancet Infect Dis. 2011 May;11(5):343.

family: Marty

full_name: Francisco M Marty

given: Francisco M

family: Ljungman

full_name: Per Ljungman

given: Per

family: Papanicolaou

full_name: Genovefa A Papanicolaou

given: Genovefa A

family: Winston

full_name: Drew J Winston

given: Drew J

family: Chemaly

full_name: Roy F Chemaly

given: Roy F

family: Strasfeld

full_name: Lynne Strasfeld

given: Lynne

family: Young

full_name: Jo-Anne H Young

given: Jo-Anne H

family: Rodriguez

full_name: Tulio Rodriguez

given: Tulio

family: Maertens

full_name: Johan Maertens

given: Johan

family: Schmitt

full_name: Michael Schmitt

given: Michael

family: Einsele

full_name: Hermann Einsele

given: Hermann

family: Ferrant

full_name: Augustin Ferrant

given: Augustin

family: Lipton

full_name: Jeffrey H Lipton

given: Jeffrey H

family: Villano

full_name: Stephen A Villano

given: Stephen A

family: Chen

full_name: Hongzi Chen

given: Hongzi

family: Boeckh

full_name: Michael Boeckh

journal_name: The Lancet Infectious Diseases

lead_sponsor: Shire

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

location_facility: University of Iowa Hospitals and Clinics

location_facility: Cliniques Universitaires St,Luc Dept Hematology

location_facility: New York Presbyterian Hospital,Weill Cornell Medical Center

location_facility: University of Pittsburgh Cancer Institute

location_facility: University Medical Center University of Louisville Hospital

location_facility: Ireland Cancer Center Case Western Reserve University

location_facility: CHU Sart -Tilman Department of Medicine, Hematology

location_facility: Washington University School of Medicine

location_facility: Universitaetsklinikum Koeln, Clinic I for internal Medicine

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University of Kentucky Chandler Medical Center

location_facility: University of Arkansas Myeloma Institute

title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus Disease in Recipients of Allogeneic Stem Cell Transplants.

summary: The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.


title: A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer

summary: The objective of this study is to assess the response of patupilone plus prednisone compared to docetaxel plus prednisone on prostate specific antigen (PSA) in patients with metastatic hormone refractory prostate cancer. Additionally, this study will assess the response on measureable disease and the effects on patient-reported outcomes.

ReferenceCitation: de Liaño AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

family: de Liaño

full_name: A G de Liaño

given: A G

family: Reig

full_name: O Reig

given: O

family: Mellado

full_name: B Mellado

given: B

family: Martin

full_name: C Martin

given: C

family: Rull

full_name: E U Rull

given: E U

family: Maroto

full_name: J P Maroto

given: J P

journal_name: British Journal of Cancer

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

location_country:
Italy
Germany
France
Singapore
Belgium
Australia
Spain
United States

location_facility: NorthWest Georgia Oncology Centers Marietta Center

location_facility: University Chicago Hospital StudyCoordinator:CEPO906A2229

location_facility: University of California San Diego Dept of Moores Cancer Center

location_facility: Oregon Health & Science University StudyCoordinator:CEPO906A2229

location_facility: University of Colorado Dept. of Univ. of Colorado

location_facility: Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Center

location_facility: MD Anderson Cancer Center - Orlando CEPO906A2229

location_facility: H. Lee Moffitt Cancer Center/University of South Florida Department of Genitourology


title: A Comparative Study of Chronic Hepatitis B Subjects Treated With Entecavir Plus Tenofovir Combination Therapy vs. Entecavir Monotherapy in Adults Who Are Treatment-Naive to Nucleosides and Nucleotides: The BE-LOW Study

summary: The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.

ReferenceCitation: Lok AS, Trinh H, Carosi G, Akarca US, Gadano A, Habersetzer F, Sievert W, Wong D, Lovegren M, Cohen D, Llamoso C. Efficacy of entecavir with or without tenofovir disoproxil fumarate for nucleos(t)ide-naïve patients with chronic hepatitis B. Gastroenterology. 2012 Sep;143(3):619-628.e1. doi: 10.1053/j.gastro.2012.05.037. Epub 2012 May 27.

family: Lok

full_name: Anna S. Lok

given: Anna S.

family: Trinh

full_name: Huy Trinh

given: Huy

family: Carosi

full_name: Giampiero Carosi

given: Giampiero

family: Akarca

full_name: Ulus S. Akarca

given: Ulus S.

family: Gadano

full_name: Adrian Gadano

given: Adrian

family: Habersetzer

full_name: François Habersetzer

given: François

family: Sievert

full_name: William Sievert

given: William

family: Wong

full_name: David Wong

given: David

family: Lovegren

full_name: Meghan Lovegren

given: Meghan

family: Cohen

full_name: David Cohen

family: Llamoso

full_name: Cyril Llamoso

given: Cyril

journal_name: Gastroenterology

title: Efficacy of Entecavir With or Without Tenofovir Disoproxil Fumarate for Nucleos(t)ide-Naïve Patients With Chronic Hepatitis B

location_country:
Italy
Brazil
United States
South Africa
India
Mexico
France
Poland
Argentina
Australia
Russian Federation
Turkey
Canada

location_facility: Maryland Digestive Disease Research, Llc


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

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

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

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Colombel

full_name: Jean–Frederic Colombel

given: Jean–Frederic

family: Sands

full_name: Bruce E. Sands

given: Bruce E.

family: Rutgeerts

full_name: Paul Rutgeerts

given: Paul

family: Targan

full_name: Stephan R. Targan

given: Stephan R.

family: Panaccione

full_name: Remo Panaccione

given: Remo

family: Bressler

full_name: Brian Bressler

given: Brian

family: Geboes

full_name: Karl Geboes

given: Karl

family: Schreiber

full_name: Stefan Schreiber

given: Stefan

family: Aranda

full_name: Richard Aranda

given: Richard

family: Gujrathi

full_name: Sheila Gujrathi

given: Sheila

family: Luo

full_name: Allison Luo

given: Allison

family: Peng

full_name: Yun Peng

given: Yun

family: Salter–Cid

full_name: Luisa Salter–Cid

given: Luisa

family: Hanauer

full_name: Stephen B. Hanauer

given: Stephen B.

title: Abatacept for Crohn's Disease and Ulcerative Colitis

location_country:
Italy
United States
Brazil
South Africa
India
Switzerland
Mexico
Netherlands
Germany
France
Poland
Belgium
Australia
Puerto Rico
Denmark
Canada
Czech Republic

location_facility: Gastrointestinal & Liver Diseases Consultants

location_facility: U Of Rochester Gastroenterology And Hepatology

location_facility: University Of North Carolina At Chapel Hill

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

location_facility: Charlotte Gastroenterology & Hepatology, Pllc

location_facility: Kansas City Gastroenterology And Hepatology