title: A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid in the Treatment of Bone Disease in Subjects With Newly Diagnosed Multiple Myeloma

summary: The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.

primary_purpose: Supportive Care

ReferenceCitation: Raje N, Roodman GD, Willenbacher W, Shimizu K, García-Sanz R, Terpos E, Kennedy L, Sabatelli L, Intorcia M, Hechmati G. A cost-effectiveness analysis of denosumab for the prevention of skeletal-related events in patients with multiple myeloma in the United States of America. J Med Econ. 2018 May;21(5):525-536. doi: 10.1080/13696998.2018.1445634. Epub 2018 Mar 5.

ReferenceCitation: Raje N, Terpos E, Willenbacher W, Shimizu K, García-Sanz R, Durie B, Legieć W, Krejčí M, Laribi K, Zhu L, Cheng P, Warner D, Roodman GD. Denosumab versus zoledronic acid in bone disease treatment of newly diagnosed multiple myeloma: an international, double-blind, double-dummy, randomised, controlled, phase 3 study. Lancet Oncol. 2018 Mar;19(3):370-381. doi: 10.1016/S1470-2045(18)30072-X. Epub 2018 Feb 9.

ReferenceCitation: Terpos E, Raje N, Croucher P, Garcia-Sanz R, Leleu X, Pasteiner W, Wang Y, Glennane A, Canon J, Pawlyn C. Denosumab compared with zoledronic acid on PFS in multiple myeloma: exploratory results of an international phase 3 study. Blood Adv. 2021 Feb 9;5(3):725-736. doi: 10.1182/bloodadvances.2020002378.

name: Department of Clinical Therapeutics, Alexandra General Hospital, National and Kapodistrian University of Athens School of Medicine, Athens, Greece;

family: Terpos

full_name: Evangelos Terpos

given: Evangelos

name: Center for Multiple Myeloma, Massachusetts General Hospital, Boston, MA;

family: Raje

full_name: Noopur Raje

given: Noopur

name: Garvan Institute of Medical Research, Sydney, NSW, Australia;

name: Faculty of Medicine, St Vincent’s Clinical School, UNSW Sydney, Sydney, NSW, Australia;

family: Croucher

full_name: Peter Croucher

given: Peter

name: Department of Hematology, Hospital Universitario de Salamanca, Salamanca, Spain;

family: Garcia-Sanz

full_name: Ramon Garcia-Sanz

given: Ramon

name: Department of Hematology, Hôpital La Mileterie, Poitiers, France;

family: Leleu

full_name: Xavier Leleu

given: Xavier

family: Pasteiner

full_name: Waltraud Pasteiner

given: Waltraud

family: Wang

full_name: Yang Wang

given: Yang

family: Glennane

full_name: Anthony Glennane

given: Anthony

family: Canon

full_name: Jude Canon

given: Jude

name: The Institute of Cancer Research and The Royal Marsden Hospital NHS Foundation Trust, London, United Kingdom

family: Pawlyn

full_name: Charlotte Pawlyn

given: Charlotte

journal_name: Blood Advances

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

ReferenceCitation: Huang SY, Yoon SS, Shimizu K, Chng WJ, Chang CS, Wong RS, Gao S, Wang Y, Gordon SW, Glennane A, Min CK. Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study-Asian Subgroup Analysis. Adv Ther. 2020 Jul;37(7):3404-3416. doi: 10.1007/s12325-020-01395-x. Epub 2020 Jun 10.

family: Huang

full_name: Shang-Yi Huang

given: Shang-Yi

family: Yoon

full_name: Sung-Soo Yoon

given: Sung-Soo

family: Shimizu

full_name: Kazuyuki Shimizu

given: Kazuyuki

family: Chng

full_name: Wee Joo Chng

given: Wee Joo

family: Chang

full_name: Cheng-Shyong Chang

given: Cheng-Shyong

family: Wong

full_name: Raymond Siu-Ming Wong

given: Raymond Siu-Ming

family: Gao

full_name: Seasea Gao

given: Seasea

title: Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study—Asian Subgroup Analysis

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

location_country:
Malaysia
Greece
Australia
Russian Federation
Taiwan
Ukraine
France
Japan
Lithuania
Poland
Slovakia
Canada
Korea, Republic of
Hong Kong
Switzerland
Bulgaria
Singapore
Hungary
Ireland
Portugal
United States
Germany
United Kingdom
Italy
Austria
Czechia
New Zealand
Spain
Turkey


title: Observational Study to Assess Clinical Management Patterns in Patients With Hospitalised Community-Acquired Pneumonia (CAP) or Complicated Skin and Skin Structure Infections (cSSSI)

acronym: REACH

summary: This study will collect real-life data from patients with community acquired pneumonia (CAP) OR complicated skin and skin structure infections (cSSSI) to assess the burden of the disease, review the treatment pathways, evaluate how health resources are used and identify any areas of unmet medical needs. The aim of the study is to compare how patients who are admitted to hospital with CAP or cSSSI are managed across Europe. This will be done by collecting data to understand the patient and disease characteristics, current practice of treatment, and outcomes for the patient. Overall 4000 patients will be recruited from 10 European countries.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Garau J, Blasi F, Medina J, McBride K, Ostermann H; REACH study group. Early response to antibiotic treatment in European patients hospitalized with complicated skin and soft tissue infections: analysis of the REACH study. BMC Infect Dis. 2015 Feb 19;15:78. doi: 10.1186/s12879-015-0822-2.

family: Garau

full_name: Javier Garau

given: Javier

sequence: first

family: Blasi

full_name: Francesco Blasi

given: Francesco

sequence: additional

family: Medina

full_name: Jesús Medina

given: Jesús

family: McBride

full_name: Kyle McBride

given: Kyle

family: Ostermann

full_name: Helmut Ostermann

given: Helmut

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMC Infectious Diseases

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Blasi F, Ostermann H, Racketa J, Medina J, McBride K, Garau J; REACH study group. Early versus later response to treatment in patients with community-acquired pneumonia: analysis of the REACH study. Respir Res. 2014 Jan 22;15:6. doi: 10.1186/1465-9921-15-6.

family: Racketa

full_name: Jill Racketa

given: Jill

journal_name: Respiratory Research

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

ReferenceCitation: Blasi F, Garau J, Medina J, Ávila M, McBride K, Ostermann H; REACH study group. Current management of patients hospitalized with community-acquired pneumonia across Europe: outcomes from REACH. Respir Res. 2013 Apr 15;14:44. doi: 10.1186/1465-9921-14-44.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

location_country:
Italy
Netherlands
Spain
France
Greece
Belgium
Portugal
Turkey
Germany
United Kingdom


ReferenceType: result

ReferenceCitation: Agnelli G, George DJ, Kakkar AK, Fisher W, Lassen MR, Mismetti P, Mouret P, Chaudhari U, Lawson F, Turpie AG; SAVE-ONCO Investigators. Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med. 2012 Feb 16;366(7):601-9. doi: 10.1056/NEJMoa1108898.

family: Agnelli

full_name: Giancarlo Agnelli

given: Giancarlo

family: George

full_name: Daniel J. George

given: Daniel J.

family: Kakkar

full_name: Ajay K. Kakkar

given: Ajay K.

family: Fisher

full_name: William Fisher

given: William

family: Lassen

full_name: Michael R. Lassen

given: Michael R.

family: Mismetti

full_name: Patrick Mismetti

given: Patrick

family: Mouret

full_name: Patrick Mouret

family: Chaudhari

full_name: Umesh Chaudhari

given: Umesh

family: Lawson

full_name: Francesca Lawson

given: Francesca

family: Turpie

full_name: Alexander G.G. Turpie

given: Alexander G.G.

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: Semuloparin for Thromboprophylaxis in Patients Receiving Chemotherapy for Cancer

ReferenceCitation: Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12:CD008500. doi: 10.1002/14651858.CD008500.pub5.

name: Institute of Social and Preventive Medicine (ISPM); University of Bern; Bern Switzerland

family: Rutjes

full_name: Anne WS Rutjes

given: Anne WS

name: Department of Medical, Oral and Biotechnological Sciences; University "G. D'Annunzio" of Chieti-Pescara; Chieti Italy

family: Porreca

full_name: Ettore Porreca

given: Ettore

name: Internal Medicine Unit; "University G. D'Annunzio" Foundation; Chieti Italy

family: Candeloro

full_name: Matteo Candeloro

given: Matteo

family: Valeriani

full_name: Emanuele Valeriani

given: Emanuele

name: Department of Medicine and Ageing Sciences; University "G. D'Annunzio" of Chieti-Pescara; Chieti Scalo Italy

name: Department of Vascular Medicine; Academic Medical Center; Amsterdam Netherlands

family: Di Nisio

full_name: Marcello Di Nisio

given: Marcello

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

design_allocation: Randomized

intervention_type: Drug

study_type: Interventional

lead_sponsor: Sanofi

primary_purpose: Prevention

location_country:
Peru
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
Ukraine
India
Spain
Croatia
France
Lithuania
Poland
Slovakia
Norway
Argentina
Indonesia
Canada
Slovenia
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Bulgaria
Hungary
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Israel
Belarus
Estonia
Latvia

acronym: SAVE-ONCO

location_facility:
Investigational Site Number 276030
Investigational Site Number 376003
Investigational Site Number 124007
Investigational Site Number 380013
Investigational Site Number 840063
Investigational Site Number 616009
Investigational Site Number 616002
Investigational Site Number 056008
Investigational Site Number 710002
Investigational Site Number 380019
Investigational Site Number 191007
Investigational Site Number 191003
Investigational Site Number 076003
Investigational Site Number 250017
Investigational Site Number 276034
Investigational Site Number 356020
Investigational Site Number 348007
Investigational Site Number 300004
Investigational Site Number 620008
Investigational Site Number 752005
Investigational Site Number 124012
Investigational Site Number 428002
Investigational Site Number 124003
Investigational Site Number 156019
Investigational Site Number 191006
Investigational Site Number 356003
Investigational Site Number 840007
Investigational Site Number 276013
Investigational Site Number 124013
Investigational Site Number 348009
Investigational Site Number 528005
Investigational Site Number 840009
Investigational Site Number 250024
Investigational Site Number 156030
Investigational Site Number 376006
Investigational Site Number 643007
Investigational Site Number 276010
Investigational Site Number 036009
Investigational Site Number 348012
Investigational Site Number 203007
Investigational Site Number 344001
Investigational Site Number 840001
Investigational Site Number 410003
Investigational Site Number 076002
Investigational Site Number 276024
Investigational Site Number 643009
Investigational Site Number 756006
Investigational Site Number 156029
Investigational Site Number 276037
Investigational Site Number 356014
Investigational Site Number 604008
Investigational Site Number 056005
Investigational Site Number 643020
Investigational Site Number 840037
Investigational Site Number 840050
Investigational Site Number 036006
Investigational Site Number 752003
Investigational Site Number 250019
Investigational Site Number 032007
Investigational Site Number 458004
Investigational Site Number 840070
Investigational Site Number 380010
Investigational Site Number 076024
Investigational Site Number 076020
Investigational Site Number 840051
Investigational Site Number 191005
Investigational Site Number 076012
Investigational Site Number 276011
Investigational Site Number 840024
Investigational Site Number 203003
Investigational Site Number 348004
Investigational Site Number 276020
Investigational Site Number 191001
Investigational Site Number 356001
Investigational Site Number 724013
Investigational Site Number 840073
Investigational Site Number 688004
Investigational Site Number 826001
Investigational Site Number 156012
Investigational Site Number 440002
Investigational Site Number 484012
Investigational Site Number 643021
Investigational Site Number 826013
Investigational Site Number 484007
Investigational Site Number 642008
Investigational Site Number 840004
Investigational Site Number 705002
Investigational Site Number 616005
Investigational Site Number 840003
Investigational Site Number 484002
Investigational Site Number 616003
Investigational Site Number 826009
Investigational Site Number 056004
Investigational Site Number 840029
Investigational Site Number 112003
Investigational Site Number 156026
Investigational Site Number 616015
Investigational Site Number 156013
Investigational Site Number 826011
Investigational Site Number 643003
Investigational Site Number 380014
Investigational Site Number 360001
Investigational Site Number 604007
Investigational Site Number 170008
Investigational Site Number 528001
Investigational Site Number 840075
Investigational Site Number 756004
Investigational Site Number 156024
Investigational Site Number 380016
Investigational Site Number 112001
Investigational Site Number 840016
Investigational Site Number 642004
Investigational Site Number 250020
Investigational Site Number 360004
Investigational Site Number 410006
Investigational Site Number 643022
Investigational Site Number 604004
Investigational Site Number 643019
Investigational Site Number 100003
Investigational Site Number 036008
Investigational Site Number 643010
Investigational Site Number 724011
Investigational Site Number 724001
Investigational Site Number 156022
Investigational Site Number 804002
Investigational Site Number 170006
Investigational Site Number 643024
Investigational Site Number 643017
Investigational Site Number 380005
Investigational Site Number 040002
Investigational Site Number 840033
Investigational Site Number 620003
Investigational Site Number 076011
Investigational Site Number 840074
Investigational Site Number 250010
Investigational Site Number 840060
Investigational Site Number 410008
Investigational Site Number 276022
Investigational Site Number 158004
Investigational Site Number 276003
Investigational Site Number 724002
Investigational Site Number 276021
Investigational Site Number 380008
Investigational Site Number 688007
Investigational Site Number 840042
Investigational Site Number 428003
Investigational Site Number 250002
Investigational Site Number 604010
Investigational Site Number 642006
Investigational Site Number 484010
Investigational Site Number 156011
Investigational Site Number 156031
Investigational Site Number 372002
Investigational Site Number 826005
Investigational Site Number 036007
Investigational Site Number 688005
Investigational Site Number 276035
Investigational Site Number 276032
Investigational Site Number 112004
Investigational Site Number 804004
Investigational Site Number 156008
Investigational Site Number 276038
Investigational Site Number 356025
Investigational Site Number 620002
Investigational Site Number 036004
Investigational Site Number 348010
Investigational Site Number 724005
Investigational Site Number 356012
Investigational Site Number 643023
Investigational Site Number 348005
Investigational Site Number 380012
Investigational Site Number 724012
Investigational Site Number 840035
Investigational Site Number 233001
Investigational Site Number 380001
Investigational Site Number 604012
Investigational Site Number 428001
Investigational Site Number 643001
Investigational Site Number 276019
Investigational Site Number 076017
Investigational Site Number 372003
Investigational Site Number 380007
Investigational Site Number 484008
Investigational Site Number 380017
Investigational Site Number 484006
Investigational Site Number 076015
Investigational Site Number 276008
Investigational Site Number 203004
Investigational Site Number 380006
Investigational Site Number 804006
Investigational Site Number 124006
Investigational Site Number 372004
Investigational Site Number 620004
Investigational Site Number 076009
Investigational Site Number 076014
Investigational Site Number 076023
Investigational Site Number 156003
Investigational Site Number 705003
Investigational Site Number 250006
Investigational Site Number 643008
Investigational Site Number 348001
Investigational Site Number 620007
Investigational Site Number 528003
Investigational Site Number 410002
Investigational Site Number 840066
Investigational Site Number 356018
Investigational Site Number 036005
Investigational Site Number 356019
Investigational Site Number 356013
Investigational Site Number 276005
Investigational Site Number 643005
Investigational Site Number 156028
Investigational Site Number 208001
Investigational Site Number 380015
Investigational Site Number 356017
Investigational Site Number 616013
Investigational Site Number 076027
Investigational Site Number 410004
Investigational Site Number 348006
Investigational Site Number 032006
Investigational Site Number 616008
Investigational Site Number 604009
Investigational Site Number 276006
Investigational Site Number 380020
Investigational Site Number 710003
Investigational Site Number 156004
Investigational Site Number 642010
Investigational Site Number 276017
Investigational Site Number 840047
Investigational Site Number 410007
Investigational Site Number 642002
Investigational Site Number 276031
Investigational Site Number 036002
Investigational Site Number 840028
Investigational Site Number 410009
Investigational Site Number 032004
Investigational Site Number 276016
Investigational Site Number 528006
Investigational Site Number 840014
Investigational Site Number 124009
Investigational Site Number 250001
Investigational Site Number 484003
Investigational Site Number 356008
Investigational Site Number 840020
Investigational Site Number 276009
Investigational Site Number 360002
Investigational Site Number 348011
Investigational Site Number 840059
Investigational Site Number 040003
Investigational Site Number 826014
Investigational Site Number 250003
Investigational Site Number 156009
Investigational Site Number 124001
Investigational Site Number 356004
Investigational Site Number 840052
Investigational Site Number 056009
Investigational Site Number 458005
Investigational Site Number 804011
Investigational Site Number 703003
Investigational Site Number 276012
Investigational Site Number 170004
Investigational Site Number 804008
Investigational Site Number 826004
Investigational Site Number 410005
Investigational Site Number 380011
Investigational Site Number 616014
Investigational Site Number 840046
Investigational Site Number 380004
Investigational Site Number 440001
Investigational Site Number 300002
Investigational Site Number 840064
Investigational Site Number 376007
Investigational Site Number 724006
Investigational Site Number 752002
Investigational Site Number 752001
Investigational Site Number 156027
Investigational Site Number 032005
Investigational Site Number 356016
Investigational Site Number 076001
Investigational Site Number 056012
Investigational Site Number 840022
Investigational Site Number 616018
Investigational Site Number 604006
Investigational Site Number 643015
Investigational Site Number 170010
Investigational Site Number 191008
Investigational Site Number 276029
Investigational Site Number 376001
Investigational Site Number 250014
Investigational Site Number 356005
Investigational Site Number 604011
Investigational Site Number 036001
Investigational Site Number 840026
Investigational Site Number 356006
Investigational Site Number 356024
Investigational Site Number 643016
Investigational Site Number 250012
Investigational Site Number 356015
Investigational Site Number 356023
Investigational Site Number 250025
Investigational Site Number 840006
Investigational Site Number 076016
Investigational Site Number 616001
Investigational Site Number 380009
Investigational Site Number 724004
Investigational Site Number 458001
Investigational Site Number 642001
Investigational Site Number 458003
Investigational Site Number 124010
Investigational Site Number 616004
Investigational Site Number 643018
Investigational Site Number 826007
Investigational Site Number 276023
Investigational Site Number 250005
Investigational Site Number 376004
Investigational Site Number 840031
Investigational Site Number 826015
Investigational Site Number 250021
Investigational Site Number 056011
Investigational Site Number 604002
Investigational Site Number 840038
Investigational Site Number 724010
Investigational Site Number 804005
Investigational Site Number 276015
Investigational Site Number 840011
Investigational Site Number 578001
Investigational Site Number 840008
Investigational Site Number 056002
Investigational Site Number 380003
Investigational Site Number 410001
Investigational Site Number 643006
Investigational Site Number 356002
Investigational Site Number 040004
Investigational Site Number 356011
Investigational Site Number 724007
Investigational Site Number 112002
Investigational Site Number 152002
Investigational Site Number 124008
Investigational Site Number 840005
Investigational Site Number 076018
Investigational Site Number 804009
Investigational Site Number 643012
Investigational Site Number 076008
Investigational Site Number 170002
Investigational Site Number 156020
Investigational Site Number 124002
Investigational Site Number 840018
Investigational Site Number 076004
Investigational Site Number 840010
Investigational Site Number 724003
Investigational Site Number 643011
Investigational Site Number 840072
Investigational Site Number 840034
Investigational Site Number 356009
Investigational Site Number 826002
Investigational Site Number 348003
Investigational Site Number 604003
Investigational Site Number 840019
Investigational Site Number 840048
Investigational Site Number 276002
Investigational Site Number 724008
Investigational Site Number 604005
Investigational Site Number 616010
Investigational Site Number 804010
Investigational Site Number 642003
Investigational Site Number 840021
Investigational Site Number 826016
Investigational Site Number 826010
Investigational Site Number 076010
Investigational Site Number 616019
Investigational Site Number 276004
Investigational Site Number 528004
Investigational Site Number 156021
Investigational Site Number 804001
Investigational Site Number 036003
Investigational Site Number 156025
Investigational Site Number 604001
Investigational Site Number 840032
Investigational Site Number 056006
Investigational Site Number 076006
Investigational Site Number 300003
Investigational Site Number 643004
Investigational Site Number 076022
Investigational Site Number 076026
Investigational Site Number 032003
Investigational Site Number 643014
Investigational Site Number 156014
Investigational Site Number 276007
Investigational Site Number 826017
Investigational Site Number 250004
Investigational Site Number 124011
Investigational Site Number 250027
Investigational Site Number 246001
Investigational Site Number 616021
Investigational Site Number 276025
Investigational Site Number 616006
Investigational Site Number 688002
Investigational Site Number 840067
Investigational Site Number 348008
Investigational Site Number 170007
Investigational Site Number 170005
Investigational Site Number 203008
Investigational Site Number 056010
Investigational Site Number 840025
Investigational Site Number 840069
Investigational Site Number 620009
Investigational Site Number 056003
Investigational Site Number 076007
Investigational Site Number 191004
Investigational Site Number 100001
Investigational Site Number 276014

type: EudraCT Number

title: A Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy

summary:
The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism [VTE] in cancer patients at high risk for VTE and who were undergoing chemotherapy.

The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.


title: Prospective, Randomized, Double-blind, Multicenter, Multinational Study Comparing Efficacy and Safety of Moxifloxacin 400 mg po od for 14 Days With Ofloxacin 400 mg po Bid Plus Metronidazole 500 mg po Bid for 14 Days in Patients With Uncomplicated Pelvic Inflammatory Disease (PID)

acronym: MAIDEN

summary: Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

primary_purpose: Treatment

lead_sponsor: Bayer

location_country:
Italy
South Africa
Sweden
Finland
France
Poland
Greece
Lithuania
Hungary
Russian Federation
Denmark
Germany
United Kingdom

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase III Randomized Study Evaluating the Efficacy and Safety of Continued and Re-induced Bevacizumab in Combination With Chemotherapy for Patients With Locally Recurrent or Metastatic Breast Cancer After First-line Chemotherapy and Bevacizumab Treatment

summary: This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.

ReferenceCitation: Vrdoljak E, Marschner N, Zielinski C, Gligorov J, Cortes J, Puglisi F, Aapro M, Fallowfield L, Fontana A, Inbar M, Kahan Z, Welt A, Lévy C, Brain E, Pivot X, Putzu C, González Martín A, de Ducla S, Easton V, von Minckwitz G. Final results of the TANIA randomised phase III trial of bevacizumab after progression on first-line bevacizumab therapy for HER2-negative locally recurrent/metastatic breast cancer. Ann Oncol. 2016 Nov;27(11):2046-2052. Epub 2016 Aug 8.

ReferenceCitation: von Minckwitz G, Puglisi F, Cortes J, Vrdoljak E, Marschner N, Zielinski C, Villanueva C, Romieu G, Lang I, Ciruelos E, De Laurentiis M, Veyret C, de Ducla S, Freudensprung U, Srock S, Gligorov J. Bevacizumab plus chemotherapy versus chemotherapy alone as second-line treatment for patients with HER2-negative locally recurrent or metastatic breast cancer after first-line treatment with bevacizumab plus chemotherapy (TANIA): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1269-78. doi: 10.1016/S1470-2045(14)70439-5. Epub 2014 Sep 28.

family: von Minckwitz

full_name: Gunter von Minckwitz

given: Gunter

family: Puglisi

full_name: Fabio Puglisi

given: Fabio

family: Cortes

full_name: Javier Cortes

given: Javier

family: Vrdoljak

full_name: Eduard Vrdoljak

given: Eduard

family: Marschner

full_name: Norbert Marschner

given: Norbert

family: Zielinski

full_name: Christoph Zielinski

given: Christoph

family: Villanueva

full_name: Cristian Villanueva

given: Cristian

family: Romieu

full_name: Gilles Romieu

given: Gilles

family: Lang

full_name: István Lang

given: István

family: Ciruelos

full_name: Eva Ciruelos

given: Eva

family: De Laurentiis

full_name: Michele De Laurentiis

given: Michele

family: Veyret

full_name: Corinne Veyret

given: Corinne

family: de Ducla

full_name: Sabine de Ducla

given: Sabine

family: Freudensprung

full_name: Ulrich Freudensprung

given: Ulrich

family: Srock

full_name: Stefanie Srock

given: Stefanie

family: Gligorov

full_name: Joseph Gligorov

given: Joseph

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Hoffmann-La Roche

location_country: Italy Austria Brazil Switzerland France Croatia Greece Israel Slovakia Hungary Argentina Spain Germany


ReferenceCitation: Kopple JD, Cheung AK, Christiansen JS, Djurhuus CB, El Nahas M, Feldt-Rasmussen B, Lange M, Mitch WE, Wanner C, Wiedemann J, Ikizler TA. OPPORTUNITY: a randomized clinical trial of growth hormone on outcome in hemodialysis patients. Clin J Am Soc Nephrol. 2008 Nov;3(6):1741-51. doi: 10.2215/CJN.02760608.

family: Kopple

full_name: Joel D. Kopple

given: Joel D.

family: Cheung

full_name: Alfred K. Cheung

given: Alfred K.

family: Christiansen

full_name: Jens Sandahl Christiansen

given: Jens Sandahl

family: Djurhuus

full_name: Christian Born Djurhuus

given: Christian Born

family: El Nahas

full_name: Meguid El Nahas

given: Meguid

family: Feldt-Rasmussen

full_name: Bo Feldt-Rasmussen

given: Bo

family: Lange

full_name: Martin Lange

given: Martin

family: Mitch

full_name: William E. Mitch

given: William E.

family: Wanner

full_name: Christoph Wanner

family: Wiedemann

full_name: Jonas Wiedemann

given: Jonas

family: Ikizler

full_name: T. Alp Ikizler

given: T. Alp

journal_name: Clinical Journal of the American Society of Nephrology

oa_colors: green other

evidence: open (via free pdf)

publisher: American Society of Nephrology (ASN)

publisher_dissemination: American Society of Nephrology

publisher_group: American Society of Nephrology

publisher_normalized: American Society of Nephrology

title: OPPORTUNITY™: A Randomized Clinical Trial of Growth Hormone on Outcome in Hemodialysis Patients

ReferenceCitation: Raff AC, Meyer TW, Hostetter TH. New insights into uremic toxicity. Curr Opin Nephrol Hypertens. 2008 Nov;17(6):560-5. doi: 10.1097/MNH.0b013e32830f45b6. Review.

family: Raff

full_name: Amanda C Raff

given: Amanda C

family: Meyer

full_name: Timothy W Meyer

given: Timothy W

family: Hostetter

full_name: Thomas H Hostetter

given: Thomas H

journal_name: Current Opinion in Nephrology and Hypertension

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: New insights into uremic toxicity

status: Terminated

lead_sponsor: Novo Nordisk A/S

location_country:
Russian Federation
Denmark
India
France
Poland
Argentina
Canada
South Africa
Sweden
Hungary
Puerto Rico
China
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Israel
Spain
Turkey

acronym: OPPORTUNITY

title: Efficacy and Safety of Somatropin in Adult Patients on Chronic Haemodialysis

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

The aim of the trial is to evaluate the effect of somatropin (human growth hormone) on survival (primary end-point; "time to death" and health related quality of life in adult patients on chronic haemodialysis.


title: A Randomized Trial Of Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy

acronym: INTORSECT

summary: This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.

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

family: de Velasco

full_name: Guillermo de Velasco

given: Guillermo

family: McKay

full_name: Rana R. McKay

given: Rana R.

family: Lin

full_name: Xun Lin

given: Xun

family: Moreira

full_name: Raphel B. Moreira

given: Raphel B.

family: Simantov

full_name: Ronit Simantov

given: Ronit

family: Choueiri

full_name: Toni K. Choueiri

given: Toni K.

journal_name: Clinical Genitourinary Cancer

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

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

family: Grünwald

full_name: Viktor Grünwald

given: Viktor

family: Kalanovic

full_name: Daniel Kalanovic

given: Daniel

journal_name: European Urology

ReferenceCitation: Hutson TE, Escudier B, Esteban E, Bjarnason GA, Lim HY, Pittman KB, Senico P, Niethammer A, Lu DR, Hariharan S, Motzer RJ. Randomized phase III trial of temsirolimus versus sorafenib as second-line therapy after sunitinib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2014 Mar 10;32(8):760-7. doi: 10.1200/JCO.2013.50.3961. Epub 2013 Dec 2.

name: Thomas E. Hutson, Charles A. Sammons Cancer Center, Baylor University Medical Center, Dallas, TX; Bernard Escudier, Institut Gustave Roussy, Villejuif, France; Emilio Esteban, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain; Georg A. Bjarnason, Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada; Ho Yeong Lim, Samsung Medical Center, Seoul, Korea; Kenneth B. Pittman, The Queen Elizabeth Hospital, Woodville South, Adelaide, Australia; Peggy Senico, Pfizer, Collegeville, PA;...

family: Hutson

full_name: Thomas E. Hutson

given: Thomas E.

family: Escudier

full_name: Bernard Escudier

given: Bernard

family: Esteban

full_name: Emilio Esteban

given: Emilio

family: Bjarnason

full_name: Georg A. Bjarnason

given: Georg A.

family: Lim

full_name: Ho Yeong Lim

given: Ho Yeong

family: Pittman

full_name: Kenneth B. Pittman

given: Kenneth B.

family: Senico

full_name: Peggy Senico

given: Peggy

family: Niethammer

full_name: Andreas Niethammer

given: Andreas

publisher: American Society of Clinical Oncology (ASCO)

title: Randomized Phase III Trial of Temsirolimus Versus Sorafenib As Second-Line Therapy After Sunitinib in Patients With Metastatic Renal Cell Carcinoma

location_country:
Italy
Austria
United States
Chile
Sweden
Switzerland
Netherlands
Spain
Germany
Finland
France
Singapore
Hungary
Argentina
Australia
China
Denmark
Canada
United Kingdom
Korea, Republic of


ReferenceCitation: Hughes TP, Hochhaus A, Kantarjian HM, Cervantes F, Guilhot F, Niederwieser D, le Coutre PD, Rosti G, Ossenkoppele G, Lobo C, Shibayama H, Fan X, Menssen HD, Kemp C, Larson RA, Saglio G. Safety and efficacy of switching to nilotinib 400 mg twice daily for patients with chronic myeloid leukemia in chronic phase with suboptimal response or failure on front-line imatinib or nilotinib 300 mg twice daily. Haematologica. 2014 Jul;99(7):1204-11. doi: 10.3324/haematol.2013.091272. Epub 2014 Feb 14.

family: Hughes

full_name: T. P. Hughes

given: T. P.

family: Hochhaus

full_name: A. Hochhaus

given: A.

family: Kantarjian

full_name: H. M. Kantarjian

given: H. M.

family: Cervantes

full_name: F. Cervantes

given: F.

family: Guilhot

full_name: F. Guilhot

family: Niederwieser

full_name: D. Niederwieser

given: D.

family: le Coutre

full_name: P. D. le Coutre

given: P. D.

family: Rosti

full_name: G. Rosti

given: G.

family: Ossenkoppele

full_name: G. Ossenkoppele

family: Lobo

full_name: C. Lobo

given: C.

family: Shibayama

full_name: H. Shibayama

given: H.

family: Fan

full_name: X. Fan

given: X.

family: Menssen

full_name: H. D. Menssen

given: H. D.

family: Kemp

full_name: C. Kemp

family: Larson

full_name: R. A. Larson

given: R. A.

family: Saglio

full_name: G. Saglio

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

repository_institution: University of Turin - Institutional Research Information System University of Turin

repositories_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

publisher: Ferrata Storti Foundation (Haematologica)

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

publisher_group: Ferrata Storti Foundation (Haematologica)

publisher_normalized: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Hughes TP, Saglio G, Kantarjian HM, Guilhot F, Niederwieser D, Rosti G, Nakaseko C, De Souza CA, Kalaycio ME, Meier S, Fan X, Menssen HD, Larson RA, Hochhaus A. Early molecular response predicts outcomes in patients with chronic myeloid leukemia in chronic phase treated with frontline nilotinib or imatinib. Blood. 2014 Feb 27;123(9):1353-60. doi: 10.1182/blood-2013-06-510396. Epub 2013 Dec 11.

name: South Australian Health and Medical Research Institute, University of Adelaide, Adelaide, SA, Australia;

name: Division of Haematology and Centre for Cancer Biology, South Australian Pathology, Adelaide, SA, Australia;

name: The University of Texas MD Anderson Cancer Center, Houston, TX;

name: Institut National de la Santé et de la Recherche Médicale Centre d'Investigation Clinique 0802, Centre Hospitalier Universitaire de Poitiers, Poitiers, France;

name: University of Leipzig, Leipzig, Saxony, Germany;

name: Chiba University Hospital, Chiba, Japan;

name: University of Campinas, Campinas, Brazil;

name: Abteilung Hämatologie/Onkologie, Universitätsklinikum Jena, Jena, Thuringia, Germany

ReferenceCitation: Hochhaus A, Saglio G, Larson RA, Kim DW, Etienne G, Rosti G, De Souza C, Kurokawa M, Kalaycio ME, Hoenekopp A, Fan X, Shou Y, Kantarjian HM, Hughes TP. Nilotinib is associated with a reduced incidence of BCR-ABL mutations vs imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase. Blood. 2013 May 2;121(18):3703-8. doi: 10.1182/blood-2012-04-423418. Epub 2013 Mar 15.

name: Abteilung Hämatologie/Onkologie, Universitätsklinikum Jena, Jena, Germany;

name: San Luigi Gonzaga Hospital, University of Turin, Orbassano, Italy;

name: University of Chicago Medical Center, Chicago, IL;

name: St. Mary’s Hospital, Catholic University of Korea, Seoul, Korea;

name: Institute L. e A. Seràgnoli, University of Bologna, Bologna, Italy;

name: UNICAMP, University of Campinas-SP, Campinas, Brazil;

name: University of Tokyo Hospital, Tokyo, Japan;

name: Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH;

name: MD Anderson Cancer Center, University of Texas, Houston, TX; and

name: Centre for Cancer Biology, SA Pathology, University of Adelaide, Adelaide, SA, Australia

ReferenceCitation: Branford S, Kim DW, Soverini S, Haque A, Shou Y, Woodman RC, Kantarjian HM, Martinelli G, Radich JP, Saglio G, Hochhaus A, Hughes TP, Müller MC. Initial molecular response at 3 months may predict both response and event-free survival at 24 months in imatinib-resistant or -intolerant patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase treated with nilotinib. J Clin Oncol. 2012 Dec 10;30(35):4323-9. doi: 10.1200/JCO.2011.40.5217. Epub 2012 Oct 29.

name: Susan Branford, Centre for Cancer Biology, SA Pathology, University of Adelaide; Timothy P. Hughes, Royal Adelaide Hospital, Adelaide, Australia; Dong-Wook Kim, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Korea; Simona Soverini and Giovanni Martinelli, University of Bologna, Bologna; Giuseppe Saglio, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy; Ariful Haque and Richard C. Woodman, Novartis, East Hanover, NJ; Yaping Shou, Novartis, Cambridge, MA; Hagop M...

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Initial Molecular Response at 3 Months May Predict Both Response and Event-Free Survival at 24 Months in Imatinib-Resistant or -Intolerant Patients With Philadelphia Chromosome–Positive Chronic Myeloid Leukemia in Chronic Phase Treated With Nilotinib

ReferenceCitation: Larson RA, Yin OQ, Hochhaus A, Saglio G, Clark RE, Nakamae H, Gallagher NJ, Demirhan E, Hughes TP, Kantarjian HM, le Coutre PD. Population pharmacokinetic and exposure-response analysis of nilotinib in patients with newly diagnosed Ph+ chronic myeloid leukemia in chronic phase. Eur J Clin Pharmacol. 2012 May;68(5):723-33. doi: 10.1007/s00228-011-1200-7. Epub 2011 Dec 30.

journal_name: European Journal of Clinical Pharmacology

ReferenceCitation: Kantarjian HM, Hochhaus A, Saglio G, De Souza C, Flinn IW, Stenke L, Goh YT, Rosti G, Nakamae H, Gallagher NJ, Hoenekopp A, Blakesley RE, Larson RA, Hughes TP. Nilotinib versus imatinib for the treatment of patients with newly diagnosed chronic phase, Philadelphia chromosome-positive, chronic myeloid leukaemia: 24-month minimum follow-up of the phase 3 randomised ENESTnd trial. Lancet Oncol. 2011 Sep;12(9):841-51. doi: 10.1016/S1470-2045(11)70201-7. Epub 2011 Aug 17. Erratum in: Lancet Oncol. 2011 Oct;12(11):989.

ReferenceCitation: Cortes JE, Hochhaus A, le Coutre PD, Rosti G, Pinilla-Ibarz J, Jabbour E, Gillis K, Woodman RC, Blakesley RE, Giles FJ, Kantarjian HM, Baccarani M. Minimal cross-intolerance with nilotinib in patients with chronic myeloid leukemia in chronic or accelerated phase who are intolerant to imatinib. Blood. 2011 May 26;117(21):5600-6. doi: 10.1182/blood-2010-11-318949. Epub 2011 Apr 5.

name: The University of Texas M. D. Anderson Cancer Center, Houston, TX;

name: Universitätsklinikum Jena, Jena, Germany;

name: Charité, Campus Virchow, Universitätsmedizin Berlin, Berlin, Germany;

name: University of Bologna, “L. e A. Seràgnoli,” Bologna, Italy;

name: H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL;

name: Novartis Pharmaceuticals Corporation, East Hanover, NJ; and

name: HRB Clinical Research Facility, National University of Ireland Galway & Trinity College, Dublin, Ireland

ReferenceCitation: Saglio G, Kim DW, Issaragrisil S, le Coutre P, Etienne G, Lobo C, Pasquini R, Clark RE, Hochhaus A, Hughes TP, Gallagher N, Hoenekopp A, Dong M, Haque A, Larson RA, Kantarjian HM; ENESTnd Investigators. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med. 2010 Jun 17;362(24):2251-9. doi: 10.1056/NEJMoa0912614. Epub 2010 Jun 5.

repository_institution: University of Pretoria - UpSpace Institutional Repository

title: Nilotinib versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia

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

location_country:
Finland
Malaysia
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Slovakia
Thailand
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Venezuela
Egypt
Spain
Turkey

location_facility: Kaiser Permanente - California Northern Vallejo Med Center/Med Offices

location_facility: University of Chicago Section of Hematology/Oncology

location_facility: Florida Cancer Specialists Dept. FloridaCancerSpecialists

location_facility: Cancer Centers of Florida PA Cancer Centers of FL

location_facility: University of Cincinnati / Barrett Cancer Center Dept.of Internal Med.

location_facility: Wake Forest University Health Sciences Dept. of Industry Research

location_facility: Florida Retina Institute Flordia Cancer Affilates

location_facility: Tennessee Oncology Dept. of Centennial Medical

location_facility: Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology

location_facility: Texas Cancer Center ( Medical City Dallas Hospital)

location_facility: Michigan State University / Breslin Cancer Center Breslin Cancer Center

location_facility: Indiana Blood and Marrow Institute Dept. of Indiana Blood&Marrow

location_facility: Hematology Oncology Consultants, Inc. Deptof Hem. Onc.Consunsultants

location_facility: Hackensack University Medical Center Department of Research

location_facility: Northwest Cancer Specialists Compass Oncology -BKM

location_facility: Memorial Sloan Kettering Cancer Center Clinical Trials Office

location_facility: Kansas City Cancer Center KCCC Business Office

location_facility: University of North Carolina UNC Lineberger Cancer Center

location_facility: Kaiser Permanente - California Southern Dept of Kaiser South 3

location_facility: Kaiser Permanente - California Northern Kaiser Med

location_facility: Rocky Mountain Cancer Centers RMCC - Colorado Springs

location_facility: Cancer Care Centers of South Texas HOAST CCC of So.TX- Medical Center

location_facility: University of Iowa Hospitals and Clinics Dept.of U of Iowa Hosp&Clinics

location_facility: Advanced Medical Specialties Research Dept.

location_facility: LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center

location_facility: Missouri Cancer Associates Dept. of Boone Hospital Center

location_facility: Cancer Centers of the Carolinas CC of C -Eastside

location_facility: University of California at Los Angeles Dept. of Hematology Clinic

title: A Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

summary:
In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

An extension protocol was included in this study design to allow patients who did not show sufficient response to their assigned treatments the opportunity to receive imatinib 400 mg BID (option available until protocol amendment 7) or nilotinib 400 mg BID, using an abbreviated safety and efficacy assessment schedule.


title: An Open-label, Randomized, Multi-center, Phase III Study to Compare the Safety and Efficacy of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma After Failure of Anti-angiogenic (VEGF-targeted and mTOR Inhibitor) Therapies

summary: This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients with metastatic renal cell cancer.

ReferenceCitation: Motzer RJ, Porta C, Vogelzang NJ, Sternberg CN, Szczylik C, Zolnierek J, Kollmannsberger C, Rha SY, Bjarnason GA, Melichar B, De Giorgi U, Grünwald V, Davis ID, Lee JL, Esteban E, Urbanowitz G, Cai C, Squires M, Marker M, Shi MM, Escudier B. Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Mar;15(3):286-96. doi: 10.1016/S1470-2045(14)70030-0. Epub 2014 Feb 17.

family: Motzer

full_name: Robert J Motzer

given: Robert J

family: Porta

full_name: Camillo Porta

given: Camillo

family: Vogelzang

full_name: Nicholas J Vogelzang

given: Nicholas J

family: Sternberg

full_name: Cora N Sternberg

given: Cora N

family: Szczylik

full_name: Cezary Szczylik

given: Cezary

family: Zolnierek

full_name: Jakub Zolnierek

given: Jakub

family: Kollmannsberger

full_name: Christian Kollmannsberger

given: Christian

family: Rha

full_name: Sun Young Rha

given: Sun Young

family: Bjarnason

full_name: Georg A Bjarnason

given: Georg A

family: Melichar

full_name: Bohuslav Melichar

given: Bohuslav

family: De Giorgi

full_name: Ugo De Giorgi

given: Ugo

family: Grünwald

full_name: Viktor Grünwald

given: Viktor

family: Davis

full_name: Ian D Davis

given: Ian D

family: Lee

full_name: Jae-Lyun Lee

given: Jae-Lyun

family: Esteban

full_name: Emilio Esteban

given: Emilio

family: Urbanowitz

full_name: Gladys Urbanowitz

given: Gladys

family: Cai

full_name: Can Cai

given: Can

family: Squires

full_name: Matthew Squires

given: Matthew

family: Marker

full_name: Mahtab Marker

given: Mahtab

family: Shi

full_name: Michael M Shi

given: Michael M

family: Escudier

full_name: Bernard Escudier

given: Bernard

location_country:
Greece
Australia
Belgium
Czech Republic
France
Japan
Poland
Slovakia
Thailand
Norway
Argentina
Canada
Korea, Republic of
Colombia
Sweden
Saudi Arabia
Switzerland
Netherlands
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
Spain

location_facility: Baylor Health Care System/Sammons Cancer Center Dept. of Sammons Cancer (4)

location_facility: Deke Slayton Cancer Center Deke Slayton Cancer Center (2)

location_facility: University of Minnesota Medical Center - Fairview Univ of MN

location_facility: Memorial Sloan Kettering Cancer Center Dept. of MSKCC

location_facility: Stanford University Medical Center Cancer Clinical Trials Office

location_facility: Moanalua Medical Center. Attn: Oncology Dept

location_facility: SUNY - Upstate Medical University Div. of Hematology-Oncology

location_facility: Willamette Valley Clinical Studies Williamette Valley Cancer

location_facility: Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)

location_facility: University of Maryland Medical Center UMMC

location_facility: Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)

location_facility: Comprehensive Cancer Centers of Nevada CCC of Nevada (1)

location_facility: St. Luke's Hospital and Health Network St Luke's

location_facility: Cedars Sinai Medical Center Cedars Sinai Medical Ctr. (SC)

location_facility: University of California at Los Angeles UCLA (4)

location_facility: University of Texas Southwestern Medical Center UTSW

location_facility: University of Virginia Health Systems Univ Virginia

location_facility: Florida Cancer Specialists DeptofFloridaCancerSpecialists

location_facility: Medical University of South Carolina -Hollings Cancer Center Med Univ SC

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: University of Kansas Cancer Center Univ of KS

location_facility: University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (5)

location_facility: CINJ at Cooper University Hospital Cooper

location_facility: New York Oncology Hematology, P.C. Dept. of New York Oncology. PC


ReferenceType: background

ReferenceCitation: Monk BJ, Poveda A, Vergote I, Raspagliesi F, Fujiwara K, Bae DS, Oaknin A, Ray-Coquard I, Provencher DM, Karlan BY, Lhommé C, Richardson G, Rincón DG, Coleman RL, Herzog TJ, Marth C, Brize A, Fabbro M, Redondo A, Bamias A, Tassoudji M, Navale L, Warner DJ, Oza AM. Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): a randomised, multicentre, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2014 Jul;15(8):799-808. doi: 10.1016/S1470-2045(14)70244-X. Epub 2014 Jun 17.

ReferenceCitation: Monk BJ, Poveda A, Vergote I, Raspagliesi F, Fujiwara K, Bae DS, Oaknin A, Ray-Coquard I, Provencher DM, Karlan BY, Lhommé C, Richardson G, Rincón DG, Coleman RL, Marth C, Brize A, Fabbro M, Redondo A, Bamias A, Ma H, Vogl FD, Bach BA, Oza AM. Final results of a phase 3 study of trebananib plus weekly paclitaxel in recurrent ovarian cancer (TRINOVA-1): Long-term survival, impact of ascites, and progression-free survival-2. Gynecol Oncol. 2016 Oct;143(1):27-34. doi: 10.1016/j.ygyno.2016.07.112. Epub 2016 Aug 18.

ReferenceCitation: Fujiwara K, Monk BJ, Lhommé C, Coleman RL, Brize A, Oaknin A, Ray-Coquard I, Fabbro M, Provencher D, Bamias A, Vergote I, DeCensi A, Zhang K, Vogl FD, Bach BA, Raspagliesi F. Health-related quality of life in women with recurrent ovarian cancer receiving paclitaxel plus trebananib or placebo (TRINOVA-1). Ann Oncol. 2016 Jun;27(6):1006-1013. doi: 10.1093/annonc/mdw147. Epub 2016 Mar 30.

family: Fujiwara

full_name: K. Fujiwara

given: K.

family: Monk

full_name: B.J. Monk

family: Lhommé

full_name: C. Lhommé

given: C.

family: Coleman

full_name: R.L. Coleman

family: Brize

full_name: A. Brize

given: A.

family: Oaknin

full_name: A. Oaknin

family: Ray-Coquard

full_name: I. Ray-Coquard

given: I.

family: Fabbro

full_name: M. Fabbro

given: M.

family: Provencher

full_name: D. Provencher

given: D.

family: Bamias

full_name: A. Bamias

family: Vergote

full_name: I. Vergote

family: DeCensi

full_name: A. DeCensi

family: Zhang

full_name: K. Zhang

family: Vogl

full_name: F.D. Vogl

family: Bach

full_name: B.A. Bach

family: Raspagliesi

full_name: F. Raspagliesi

given: F.

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: Amgen

location_country:
Peru
Malaysia
Greece
Romania
Belgium
Australia
Russian Federation
Czech Republic
India
Croatia
France
Japan
Poland
Canada
Slovenia
Korea, Republic of
South Africa
Chile
Sweden
Hong Kong
Switzerland
Bulgaria
Portugal
United States
United Kingdom
Italy
Brazil
Mexico
Israel
Spain
Estonia
Latvia

source: euctr

title: A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

summary:
The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.


title: Long Term Treatment With Exenatide Versus Glimepiride in Patients With Type 2 Diabetes Pretreated With Metformin (EUREXA: European Exenatide Study)

summary: This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.

ReferenceCitation: Simó R, Guerci B, Schernthaner G, Gallwitz B, Rosas-Guzmàn J, Dotta F, Festa A, Zhou M, Kiljański J. Long-term changes in cardiovascular risk markers during administration of exenatide twice daily or glimepiride: results from the European exenatide study. Cardiovasc Diabetol. 2015 Sep 4;14:116. doi: 10.1186/s12933-015-0279-z.

family: Simó

full_name: Rafael Simó

given: Rafael

family: Guerci

full_name: Bruno Guerci

given: Bruno

family: Schernthaner

full_name: Guntram Schernthaner

given: Guntram

family: Gallwitz

full_name: Baptist Gallwitz

given: Baptist

family: Rosas-Guzmàn

full_name: Juan Rosas-Guzmàn

given: Juan

family: Dotta

full_name: Francesco Dotta

given: Francesco

family: Festa

full_name: Andreas Festa

given: Andreas

family: Zhou

full_name: Ming Zhou

given: Ming

family: Kiljański

full_name: Jacek Kiljański

given: Jacek

journal_name: Cardiovascular Diabetology

ReferenceCitation: Schernthaner G, Rosas-Guzmán J, Dotta F, Guerci B, Simó R, Festa A, Kiljański J, Zhou M, Gallwitz B. Treatment escalation options for patients with type 2 diabetes after failure of exenatide twice daily or glimepiride added to metformin: results from the prospective European Exenatide (EUREXA) study. Diabetes Obes Metab. 2015 Jul;17(7):689-98. doi: 10.1111/dom.12471. Epub 2015 May 8.

full_name: G. Schernthaner

given: G.

name: Celaya Center for Specialist Medicine; Guanajuato Mexico

family: Rosas-Guzmán

full_name: J. Rosas-Guzmán

given: J.

name: Diabetes Unit; Policlinico Le Scotte, University of Siena; Siena Italy

full_name: F. Dotta

name: Hospital Brabois and CIC Inserm, University of Lorraine; Vandoeuvre-Lès-Nancy France

full_name: B. Guerci

given: B.

name: Vall d'Hebron Research Institute and CIBERDEM Carlos III Health Institute; Barcelona Spain

full_name: R. Simó

given: R.

full_name: A. Festa

full_name: J. Kiljański

name: Department of Medicine IV; Eberhard-Karls-University Tübingen; Tübingen Germany

ReferenceCitation: Gallwitz B, Guzman J, Dotta F, Guerci B, Simó R, Basson BR, Festa A, Kiljański J, Sapin H, Trautmann M, Schernthaner G. Exenatide twice daily versus glimepiride for prevention of glycaemic deterioration in patients with type 2 diabetes with metformin failure (EUREXA): an open-label, randomised controlled trial. Lancet. 2012 Jun 16;379(9833):2270-8. doi: 10.1016/S0140-6736(12)60479-6. Epub 2012 Jun 9.

location_country:
Italy
Austria
Switzerland
Mexico
United Kingdom
Finland
France
Poland
Israel
Hungary
Ireland
Spain
Germany
Czech Republic


title: Effect of Roflumilast in COPD Patients Treated With Salmeterol. A 24-week, Double-blind Study With 500 μg Roflumilast Once Daily Versus Placebo. The EOS Study

acronym: EOS

summary: The aim of the study is to compare the efficacy of roflumilast on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of salmeterol. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.

ReferenceCitation: Fabbri LM, Calverley PM, Izquierdo-Alonso JL, Bundschuh DS, Brose M, Martinez FJ, Rabe KF; M2-127 and M2-128 study groups. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):695-703. doi: 10.1016/S0140-6736(09)61252-6.

family: Fabbri

full_name: Leonardo M Fabbri

given: Leonardo M

family: Calverley

full_name: Peter MA Calverley

given: Peter MA

family: Izquierdo-Alonso

full_name: José Luis Izquierdo-Alonso

given: José Luis

family: Bundschuh

full_name: Daniela S Bundschuh

given: Daniela S

family: Brose

full_name: Manja Brose

given: Manja

family: Martinez

full_name: Fernando J Martinez

given: Fernando J

family: Rabe

full_name: Klaus F Rabe

given: Klaus F

journal_name: The Lancet

ReferenceCitation: Cazzola M, Picciolo S, Matera MG. Roflumilast in chronic obstructive pulmonary disease: evidence from large trials. Expert Opin Pharmacother. 2010 Feb;11(3):441-9. doi: 10.1517/14656560903555201. Review.

family: Cazzola

full_name: Mario Cazzola

given: Mario

family: Picciolo

full_name: Stefano Picciolo

given: Stefano

family: Matera

full_name: Maria G Matera

given: Maria G

journal_name: Expert Opinion on Pharmacotherapy

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: AstraZeneca

location_country:
Italy
Austria
South Africa
Netherlands
Germany
France
Belgium
Spain
Canada
United Kingdom

location_facility: Altana Pharma/Nycomed Investigational Sites


type: Other Identifier

title: A Six Month, Open-label Outpatient, Parallel Group Trial Assessing The Impact Of Inhaled Insulin (Exubera(Registered)) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On Two Oral Anti-diabetic Agents

summary: To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents

study_start_date_type: Actual

lead_sponsor: Pfizer

location_country: Sweden France Greece Spain Turkey Canada Portugal

location_facility: Centre de santé et de services sociaux de Chicoutimi, Centre de médecine genique communataire

location_facility: Hospital General Universitario Valle de Hebron

location_facility: Groupe Hospitalier Sud/Service d'Endocrinologie

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Hacettepe University Medical School Department of Endocrinology

location_facility: "Hygeia" Diagnostic and Therapeutic Center of Athens, Diabetes Clinic

location_facility: Associação Protectora dos Diabéticos de Portugal

location_facility: General Hospital of Athens "Laikon", 1st Propedeutic University Internal Medicine Clinic

location_facility: Dokuz Eylul University Medical School, Department of Endocrinology

location_facility: Hotel Dieu CHU, Clinique d´Endocrinologie, Maladie Metaboliques, Nutrition

location_facility: Complejo Hospitalario Carlos Haya Hospital Civil - Pabellon C

location_facility: Hospital General Universitario de Alicante

location_facility: Douglas Tweel M.D. Professional Corporation

location_facility: Istanbul University Istanbul Medical School, Department of Endocrinology

location_facility: Hôpital Jeanne d'Arc - Dommartin les Toul

location_facility: Serviço de Endocrinologia - Hospital de Egas Moniz

location_facility: Hospital Universitario Central de Asturias

location_facility: Peripheral General Hospital of Nikaia "Ag. Panteleimon", Internal Medicine Department

location_facility: Hopital LA Cavale Blanche, Service de Diabetologie

location_facility: University General Hospital of Thessaloniki "A.H.E.P.A." 1st Propedeutic University Internal Medicin

location_facility: CHU Cote de Nacre, Service d'Endocrinologie

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: "ATTIKON" University General Hospital, 2nd Propedeutic University Internal Medicine Clinic

location_facility: Hospital Clinico Universitario de Valencia

intervention_type: Other

status_simplified: Unknown


title: A Comparative Study on Clinical Efficacy and Safety of Levocetirizine 5 mg Oral Capsules Once Daily in the Morning vs. Desloratadine 5 mg Oral Capsules Once Daily in the Morning in Patients Suffering From Chronic Idiopathic Urticaria (CIU)

summary: A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus severity score over the first week of treatment

lead_sponsor: UCB Pharma

location_country:
Italy
South Africa
France
Malaysia
Romania
Belgium
Spain
Germany
United Kingdom


title: A Comparative, Randomized, Open-Label, Multicenter Study on the Efficacy and Safety of Switch Treatment With Aripiprazole in Schizophrenic Out-patients Who Are Experiencing Insufficient Efficacy With Risperidone and/or Safety and Tolerability Issues, While on Risperidone

summary: The purpose of this clinical research study is to evaluate the safety and tolerability of two switching strategies from risperidone to aripiprazole over a period of 12 weeks in out-patients who are treated in a general psychiatric practice setting and who are currently experiencing efficacy and/or safety/tolerability issues while on risperidone.

ReferenceCitation: Ryckmans V, Kahn JP, Modell S, Werner C, McQuade RD, Kerselaers W, Lissens J, Sanchez R. Switching to aripiprazole in outpatients with schizophrenia experiencing insufficient efficacy and/or safety/tolerability issues with risperidone: a randomized, multicentre, open-label study. Pharmacopsychiatry. 2009 May;42(3):114-21. doi: 10.1055/s-0028-1112134. Epub 2009 May 18.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Italy
Austria
United Kingdom
France
Greece
Hungary
Belgium
Spain
Germany
Czech Republic


title: The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Subjects With NYHA Class II Chronic Systolic Heart Failure

acronym: EMPHASIS-HF

summary:
In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. However, it is not known how patients with established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus standard heart failure medicines is being compared to placebo plus standard heart failure medicines in terms of an additional ability to prolong life and prevent re-hospitalizations for worsening heart failure in these patients.

The Data Safety Monitoring Committee (DSMC) observed during its conduct of the protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of eplerenone had met the pre-specified stopping rules in the protocol. As a result of the discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the consideration that it would be unethical not to offer this treatment to patients, the ESC recommended that all the patients in the trial should be transferred to open-label eplerenone. The Open Label Extension eplerenone arm will last for 12 months. Eplerenone is not currently approved for the indication studied in this patient population.

On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is considered to be the most appropriate way to ensure that all the subjects who participated in the double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone

design_allocation: Non-Randomized

ReferenceCitation: Ferreira JP, Lamiral Z, McMurray JJV, Swedberg K, van Veldhuisen DJ, Vincent J, Rossignol P, Pocock SJ, Pitt B, Zannad F. Impact of Insulin Treatment on the Effect of Eplerenone: Insights From the EMPHASIS-HF Trial. Circ Heart Fail. 2021 Jun;14(6):e008075. doi: 10.1161/CIRCHEARTFAILURE.120.008075. Epub 2021 Jun 15.

name: Université de Lorraine, Inserm, Centre d’Investigations Cliniques, - Plurithématique 14-33, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France (J.P.F., Z.L., P.R., F.Z.).

family: Ferreira

full_name: João Pedro Ferreira

given: João Pedro

family: Lamiral

full_name: Zohra Lamiral

given: Zohra

name: BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (J.J.V.M.).

family: McMurray

full_name: John J.V. McMurray

given: John J.V.

name: Department of Molecular and Clinical Medicine, University of Gothenburg, Sweden (K.S.).

family: Swedberg

full_name: Karl Swedberg

given: Karl

name: Department of Cardiology, University Medical Center Groningen, University of Groningen, the Netherlands (D.J.v.V.).

family: van Veldhuisen

full_name: Dirk J. van Veldhuisen

given: Dirk J.

family: Vincent

full_name: John Vincent

given: John

family: Rossignol

full_name: Patrick Rossignol

given: Patrick

name: Department of Biostatistics, London School of Hygiene and Tropical Medicine, London, United Kingdom (S.J.P.).

family: Pocock

full_name: Stuart J. Pocock

given: Stuart J.

name: Division of Cardiology, University of Michigan, Ann Arbor (B.P.).

family: Pitt

full_name: Bertram Pitt

given: Bertram

family: Zannad

full_name: Faiez Zannad

given: Faiez

journal_name: Circulation: Heart Failure

ReferenceCitation: Martens P, Ferreira JP, Vincent J, Abreu P, Busselen M, Mullens W, Tang WWH, Böhm M, Pitt B, Zannad F, Rossignol P. Serum sodium and eplerenone use in patients with a myocardial infarction and left ventricular dysfunction or heart failure: insights from the EPHESUS trial. Clin Res Cardiol. 2021 Apr 23. doi: 10.1007/s00392-021-01853-8. [Epub ahead of print]

family: Martens

full_name: Pieter Martens

given: Pieter

family: Abreu

full_name: Paula Abreu

given: Paula

family: Busselen

full_name: Martijn Busselen

given: Martijn

family: Mullens

full_name: Wilfried Mullens

given: Wilfried

family: Tang

full_name: Wilson W. H. Tang

given: Wilson W. H.

family: Böhm

full_name: Michael Böhm

given: Michael

ReferenceCitation: Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10:CD007004. doi: 10.1002/14651858.CD007004.pub4.

name: Department of Medicine; Royal North Shore Hospital; Sydney Australia

name: Sydney School of Public Health; The University of Sydney; Sydney Australia

name: Department of Emergency and Organ Transplantation; University of Bari; Bari Italy

name: Institute of Clinical Physiology; CNR - Italian National Council of Research; Reggio Calabria Italy

name: Baylor College of Medicine; Houston Texas USA

name: Department of Medicine; University of Otago Christchurch; Christchurch New Zealand

name: Cochrane Kidney and Transplant, Centre for Kidney Research; The Children's Hospital at Westmead; Westmead Australia

ReferenceCitation: Monzo L, Ferreira JP, Abreu P, Szumski A, Böhm M, McMurray JJV, Pitt B, Swedberg K, van Veldhuisen DJ, Girerd N, Vincent J, Zannad F, Rossignol P. Visit-to-visit blood pressure variation and outcomes in heart failure with reduced ejection fraction: findings from the Eplerenone in Patients with Systolic Heart Failure and Mild Symptoms trial. J Hypertens. 2020 Mar;38(3):420-425. doi: 10.1097/HJH.0000000000002275.

ReferenceCitation: Stienen S, Ferreira JP, Vincent J, Busselen M, Li B, McMurray JJV, Pitt B, Girerd N, Rossignol P, Zannad F. Estimated Long-Term Survival With Eplerenone. J Am Coll Cardiol. 2019 May 14;73(18):2357-2359. doi: 10.1016/j.jacc.2019.02.043.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Ferreira JP, Duarte K, McMurray JJV, Pitt B, van Veldhuisen DJ, Vincent J, Ahmad T, Tromp J, Rossignol P, Zannad F. Data-Driven Approach to Identify Subgroups of Heart Failure With Reduced Ejection Fraction Patients With Different Prognoses and Aldosterone Antagonist Response Patterns. Circ Heart Fail. 2018 Jul;11(7):e004926. doi: 10.1161/CIRCHEARTFAILURE.118.004926.

name: Université de Lorraine INSERM, Centre, d’Investigations Cliniques Plurithématique 1433, INSERM U1116, CHRU de Nancy, F-CRIN INI-CRCT, France (J.P.F., K.D., P.R., F.Z.).

name: Department of Physiology and Cardiothoracic Surgery, Cardiovascular Research and Development Unit, Faculty of Medicine, University of Porto, Portugal (J.P.F.).

name: BHF Cardiovascular Research Centre, University of Glasgow, Scotland, United Kingdom (J.J.V.M).

name: Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.).

name: Department of Cardiology, University of Groningen, University Medical Center Groningen, The Netherlands (D.J.v.V., J.T.).

name: Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT (T.A.).

ReferenceCitation: Rossignol P, Dobre D, McMurray JJ, Swedberg K, Krum H, van Veldhuisen DJ, Shi H, Messig M, Vincent J, Girerd N, Bakris G, Pitt B, Zannad F. Incidence, determinants, and prognostic significance of hyperkalemia and worsening renal function in patients with heart failure receiving the mineralocorticoid receptor antagonist eplerenone or placebo in addition to optimal medical therapy: results from the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF). Circ Heart Fail. 2014 Jan;7(1):51-8. doi: 10.1161/CIRCHEARTFAILURE.113.000792. Epub 2013 Dec 2.

name: From the Inserm, Centre d’Investigations Cliniques- 9501, and Inserm U1116, Nancy, France (P.R., D.D., N.G., F.Z.); CHU Nancy, Pôle de Cardiologie, Institut Lorrain du Cœur et des Vaisseaux, Vandoeuvre lès Nancy, France (P.R., D.D., N.G., F.Z.); Université de Lorraine, France (P.R., D.D., N.G., F.Z.); The British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M.); Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden (K.S.); Monash...

title: Incidence, Determinants, and Prognostic Significance of Hyperkalemia and Worsening Renal Function in Patients With Heart Failure Receiving the Mineralocorticoid Receptor Antagonist Eplerenone or Placebo in Addition to Optimal Medical Therapy

ReferenceCitation: Eschalier R, McMurray JJ, Swedberg K, van Veldhuisen DJ, Krum H, Pocock SJ, Shi H, Vincent J, Rossignol P, Zannad F, Pitt B; EMPHASIS-HF Investigators. Safety and efficacy of eplerenone in patients at high risk for hyperkalemia and/or worsening renal function: analyses of the EMPHASIS-HF study subgroups (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure). J Am Coll Cardiol. 2013 Oct 22;62(17):1585-93. doi: 10.1016/j.jacc.2013.04.086. Epub 2013 Jun 27.

title: Safety and Efficacy of Eplerenone in Patients at High Risk for Hyperkalemia and/or Worsening Renal Function

ReferenceCitation: Krum H, Shi H, Pitt B, McMurray J, Swedberg K, van Veldhuisen DJ, Vincent J, Pocock S, Zannad F; EMPHASIS-HF Study Group. Clinical benefit of eplerenone in patients with mild symptoms of systolic heart failure already receiving optimal best practice background drug therapy: analysis of the EMPHASIS-HF study. Circ Heart Fail. 2013 Jul;6(4):711-8. doi: 10.1161/CIRCHEARTFAILURE.112.000173. Epub 2013 Apr 26.

name: From the CCRE Therapeutics, Monash University, Melbourne, Australia (H.K.); Pfizer, New York, NY (H.S., J.V.); University of Michigan Medical School, Ann Arbor, MI (B.P.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.M.); Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden (K.S.); University of Groningen, University Medical Center Groningen, Groningen, The Netherlands (D.J.v.V....

title: Clinical Benefit of Eplerenone in Patients With Mild Symptoms of Systolic Heart Failure Already Receiving Optimal Best Practice Background Drug Therapy

ReferenceCitation: Rogers JK, McMurray JJ, Pocock SJ, Zannad F, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pitt B. Eplerenone in patients with systolic heart failure and mild symptoms: analysis of repeat hospitalizations. Circulation. 2012 Nov 6;126(19):2317-23. doi: 10.1161/CIRCULATIONAHA.112.110536. Epub 2012 Oct 5.

name: From the London School of Hygiene and Tropical Medicine, London, United Kingdom (J.K.R., S.J.P.); University of Glasgow, Glasgow, United Kingdom (J.J.V.M.); Nancy University, Nancy, France (F.Z.); Monash Centre of Cardiovascular Research & Education in Therapeutics, Melbourne, Australia (H.K.); University Medical Center Groningen, Groningen, Netherlands (D.J.V.); Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden (K.S.); Pfizer, New York, NY (H.S., J.V.); and University of...

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

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

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

title: Eplerenone in Patients With Systolic Heart Failure and Mild Symptoms

ReferenceCitation: Zannad F, McMurray JJ, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pocock SJ, Pitt B; EMPHASIS-HF Study Group. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011 Jan 6;364(1):11-21. doi: 10.1056/NEJMoa1009492. Epub 2010 Nov 14.

ReferenceCitation: Zannad F, McMurray JJ, Drexler H, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pitt B. Rationale and design of the Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure (EMPHASIS-HF). Eur J Heart Fail. 2010 Jun;12(6):617-22. doi: 10.1093/eurjhf/hfq049. Epub 2010 Apr 13.

name: Inserm, Centre d'Investigation Cliniques CIC 9501 and U961, CHU and Department of Cardiology; Nancy University; Nancy France

name: British Heart Foundation Cardiovascular Research Centre; University of Glasgow; Glasgow UK

name: Clinic of Cardiology and Angiology; Hannover Medical School; Hannover Germany

name: Department of Epidemiology and Preventive Medicine, Centre of Cardiovascular Research and Education in Therapeutics; Monash University; Melbourne Australia

name: Department of Cardiology, Thorax Centre; University Medical Centre; Groningen The Netherlands

name: Department of Emergency and Cardiovascular Medicine, Sahlgrenska Academy; University of Gothenburg; Göteborg Sweden

name: University of Michigan; Ann Arbor MI USA

repository_institution: The Pennsylvania State University - CiteSeer X

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

location_country:
Greece
Belgium
Australia
Russian Federation
Ukraine
India
France
Poland
Slovakia
Argentina
Canada
Korea, Republic of
South Africa
Sweden
United Arab Emirates
Hong Kong
Netherlands
Singapore
Hungary
Ireland
Portugal
United States
Germany
United Kingdom
Italy
Mexico
Czechia
Venezuela
Spain


title: A Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Herpes Simplex Candidate Vaccine (gD2-AS04) in Healthy HSV Seronegative and Seropositive Female Subjects Aged 10-17 Years.

summary:
Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study period (up to month 12).

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

ReferenceCitation: Tavares F, Cheuvart B, Heineman T, Arellano F, Dubin G. Meta-analysis of pregnancy outcomes in pooled randomized trials on a prophylactic adjuvanted glycoprotein D subunit herpes simplex virus vaccine. Vaccine. 2013 Mar 25;31(13):1759-64. doi: 10.1016/j.vaccine.2013.01.002. Epub 2013 Jan 10.

ReferenceCitation: HSV-040 Study Group, Abu-Elyazeed RR, Heineman T, Dubin G, Fourneau M, Leroux-Roels I, Leroux-Roels G, Richardus JH, Ostergaard L, Diez-Domingo J, Poder A, Van Damme P, Romanowski B, Blatter M, Silfverdal SA, Berglund J, Josefsson A, Cunningham AL, Flodmark CE, Tragiannidis A, Dobson S, Olafsson J, Puig-Barbera J, Mendez M, Barton S, Bernstein D, Mares J, Ratner P. Safety and immunogenicity of a glycoprotein D genital herpes vaccine in healthy girls 10-17 years of age: results from a randomised, controlled, double-blind trial. Vaccine. 2013 Dec 9;31(51):6136-43. doi: 10.1016/j.vaccine.2013.06.081. Epub 2013 Jul 9.

ReferenceCitation: Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
United States
Sweden
Netherlands
Spain
France
Greece
Lithuania
Norway
Hungary
Belgium
Australia
New Zealand
Romania
Estonia
Denmark
Canada
United Kingdom
Iceland

intervention_type: Biological


title: Multicenter Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in Extranodal Marginal Zone B-cell Lymphoma of Mucosa Associated Lymphoid Tissue (MALT Lymphoma)

summary:
Assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab in MALT lymphomas and determine whether the addition of Rituximab to Chlorambucil will improve the outcome of MALT lymphoma in comparison to treatment with Chlorambucil alone.

In April 2006, a third arm of treatment was added to compare the antitumor activity and safety of rituximab alone vs chlorambucil alone

ReferenceCitation: Zucca E, Conconi A, Laszlo D, López-Guillermo A, Bouabdallah R, Coiffier B, Sebban C, Jardin F, Vitolo U, Morschhauser F, Pileri SA, Copie-Bergman C, Campo E, Jack A, Floriani I, Johnson P, Martelli M, Cavalli F, Martinelli G, Thieblemont C. Addition of rituximab to chlorambucil produces superior event-free survival in the treatment of patients with extranodal marginal-zone B-cell lymphoma: 5-year analysis of the IELSG-19 Randomized Study. J Clin Oncol. 2013 Feb 10;31(5):565-72. doi: 10.1200/JCO.2011.40.6272. Epub 2013 Jan 7.

name: Emanuele Zucca and Franco Cavalli, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland; Annarita Conconi, Amedeo Avogadro University of Eastern Piedmont, Novara; Daniele Laszlo and Giovanni Martinelli, European Institute of Oncology; Irene Floriani, Mario Negri Pharmacological Research Institute, Milan; Umberto Vitolo, S. Giovanni Battista Hospital, Torino; Stefano A. Pileri, University of Bologna, Bologna; Maurizio Martelli, University “La Sapienza,” Rome, Italy; Armando López-Guillermo...

family: Zucca

full_name: Emanuele Zucca

given: Emanuele

family: Conconi

full_name: Annarita Conconi

given: Annarita

family: Laszlo

full_name: Daniele Laszlo

given: Daniele

family: López-Guillermo

full_name: Armando López-Guillermo

given: Armando

family: Bouabdallah

full_name: Reda Bouabdallah

given: Reda

family: Coiffier

full_name: Bertrand Coiffier

given: Bertrand

family: Sebban

full_name: Catherine Sebban

given: Catherine

family: Jardin

full_name: Fabrice Jardin

given: Fabrice

family: Vitolo

full_name: Umberto Vitolo

given: Umberto

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Pileri

full_name: Stefano A. Pileri

given: Stefano A.

family: Copie-Bergman

full_name: Christiane Copie-Bergman

given: Christiane

family: Campo

full_name: Elias Campo

given: Elias

family: Jack

full_name: Andrew Jack

given: Andrew

family: Floriani

full_name: Irene Floriani

given: Irene

family: Johnson

full_name: Peter Johnson

given: Peter

family: Martelli

full_name: Maurizio Martelli

given: Maurizio

family: Cavalli

full_name: Franco Cavalli

given: Franco

family: Martinelli

full_name: Giovanni Martinelli

given: Giovanni

family: Thieblemont

full_name: Catherine Thieblemont

journal_name: Journal of Clinical Oncology

title: Addition of Rituximab to Chlorambucil Produces Superior Event-Free Survival in the Treatment of Patients With Extranodal Marginal-Zone B-Cell Lymphoma: 5-Year Analysis of the IELSG-19 Randomized Study

lead_sponsor: International Extranodal Lymphoma Study Group (IELSG)

location_country:
Italy
Switzerland
France
Belgium
Spain
United Kingdom

location_facility: A.O.U. San Giovanni Battista-Molinette, S.C. Ematologia 2

location_facility: Worchestershire Acute Hospital NHS Trust

location_facility: A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia


title: A Randomised, Double-blind, Multicentre Dose-finding Phase IIb Study for up to 8 Weeks' Treatment With AZD0865 25, 50, 75 mg and Esomeprazole 40 mg, Given Orally Once Daily for the Healing of Erosive Esophagitis in Adult Subjects With GERD With Erosive Esophagitis According to the LA Classification in Adult Subjects.

summary:
The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and 75 mg).

The secondary objectives are to compare the efficacy between the three doses of AZD0865 and esomeprazole 40 mg and to evaluate the safety and tolerability of AZD0865.

ReferenceCitation: Kahrilas PJ, Persson T, Denison H, Wernersson B, Hughes N, Howden CW. Predictors of either rapid healing or refractory reflux oesophagitis during treatment with potent acid suppression. Aliment Pharmacol Ther. 2014 Sep;40(6):648-56. doi: 10.1111/apt.12877. Epub 2014 Jul 15.

name: Division of Gastroenterology and Hepatology; Feinberg School of Medicine; Northwestern University; Chicago IL USA

family: Kahrilas

full_name: P. J. Kahrilas

given: P. J.

family: Persson

full_name: T. Persson

given: T.

family: Denison

full_name: H. Denison

given: H.

family: Wernersson

full_name: B. Wernersson

given: B.

name: Research Evaluation Unit; Oxford PharmaGenesis Ltd; Oxford UK

family: Hughes

full_name: N. Hughes

given: N.

family: Howden

full_name: C. W. Howden

given: C. W.

journal_name: Alimentary Pharmacology & Therapeutics

ReferenceCitation: Kahrilas PJ, Jonsson A, Denison H, Wernersson B, Hughes N, Howden CW. Impact of regurgitation on health-related quality of life in gastro-oesophageal reflux disease before and after short-term potent acid suppression therapy. Gut. 2014 May;63(5):720-6. doi: 10.1136/gutjnl-2013-304883. Epub 2013 Jul 5.

full_name: Peter J Kahrilas

given: Peter J

family: Jonsson

full_name: Andreas Jonsson

given: Andreas

full_name: Hans Denison

given: Hans

full_name: Börje Wernersson

given: Börje

full_name: Nesta Hughes

given: Nesta

full_name: Colin W Howden

given: Colin W

journal_name: Gut

version: acceptedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_country:
Italy
Sweden
Germany
Finland
France
Norway
Denmark
United States
United Kingdom
Canada

location_facility:
Research Siteq
Research Site