title: A Phase III, Randomized, Double-blind, Placebo-controlled, Parallel Group Safety and Efficacy Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) During 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control on MDI Insulin Regimen Alone or With Metformin

summary: This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.

ReferenceCitation: Rosenstock J, Jelaska A, Frappin G, Salsali A, Kim G, Woerle HJ, Broedl UC; EMPA-REG MDI Trial Investigators. Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes. Diabetes Care. 2014 Jul;37(7):1815-23. doi: 10.2337/dc13-3055. Epub 2014 Jun 14.

family: Rosenstock

full_name: Julio Rosenstock

given: Julio

family: Jelaska

full_name: Ante Jelaska

given: Ante

family: Frappin

full_name: Guillaume Frappin

given: Guillaume

family: Salsali

full_name: Afshin Salsali

given: Afshin

family: Kim

full_name: Gabriel Kim

given: Gabriel

family: Woerle

full_name: Hans J. Woerle

given: Hans J.

family: Broedl

full_name: Uli C. Broedl

given: Uli C.

journal_name: Diabetes Care

oa_host_type: publisher

evidence: open (via page says license)

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Improved Glucose Control With Weight Loss, Lower Insulin Doses, and No Increased Hypoglycemia With Empagliflozin Added to Titrated Multiple Daily Injections of Insulin in Obese Inadequately Controlled Type 2 Diabetes

location_country:
Peru
Guatemala
Mexico
Germany
Finland
France
Bulgaria
Belgium
Russian Federation
Spain
United States
Czech Republic
Colombia
Ukraine

location_facility: 1245.49.10020 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10013 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34045 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.49101 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34047 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.75015 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.50203 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.59003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10015 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.50204 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.59004 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.32010 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10011 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10024 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51009 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10021 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52011 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33004 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10005 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.50202 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.49013 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.49002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10031 Boehringer Ingelheim Investigational Site

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location_facility: 1245.49.34044 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.72002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51010 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.59001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.32014 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34043 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.57006 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.49102 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10026 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10006 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42009 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10009 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10032 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.32007 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.49005 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.57004 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42012 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51008 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52005 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10007 Boehringer Ingelheim Investigational Site

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location_facility: 1245.49.32002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34038 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10019 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10014 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10022 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.32012 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.49104 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33011 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33010 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52009 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51006 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34039 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.72003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10004 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42010 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34041 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.70010 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52006 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42011 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.75014 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42013 Boehringer Ingelheim Investigational Site

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location_facility: 1245.49.70008 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.50205 Boehringer Ingelheim Investigational Site

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location_facility: 1245.49.33003 Boehringer Ingelheim Investigational Site

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location_facility: 1245.49.52012 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10025 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.57005 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.70006 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.75007 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10016 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33008 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.50201 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.75016 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52008 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33007 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.57002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10023 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10033 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.32013 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.72001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34016 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52004 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33009 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33012 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10030 Boehringer Ingelheim Investigational Site


title: A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease

summary: This is a randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A as compared to placebo over 12 weeks in adult subjects with moderately-to-severely active Crohn's disease. Efficacy will be assessed by proportion of subjects achieving response, defined as a decrease in Crohn's Disease Activity Index (CDAI) score of at least 100 points (clinical response). Clinical remission (CDAI score less than 150 points) will be evaluated as a key secondary endpoint. Safety will be assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram (ECG). Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form-36 version 2 (SF-36v2), EQ-5D and Work Productivity and Activity Impairment-CD (WPAI-CD) and receipt of disability.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: GlaxoSmithKline

location_country:
Australia
Belgium
Denmark
France
Japan
Poland
Slovakia
Norway
Canada
Korea, Republic of
South Africa
Sweden
Netherlands
Hungary
United States
Germany
United Kingdom
Italy
Austria
Czechia
Israel
New Zealand
Spain

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

type: Other Identifier

title: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance, Safety, and Tolerability of SAR110894D at the Doses of 0.5 mg, 2 mg, and 5 mg/Day for 24 Weeks in Patients With Mild to Moderate Alzheimer's Disease on Stable Donepezil Therapy

summary:
Primary Objective:

- To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's disease (AD) while on stable donepezil therapy

Secondary Objectives:

To explore the effect of SAR110894 on functional impairment, global clinical status and behavioral disturbances;
To assess the safety/tolerability of SAR110894;
To assess pharmacokinetic (PK) of SAR110894 and concentrations of donepezil;
To explore caregiver time consumption and distress changes.

ReferenceType: derived

ReferenceCitation: McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11:CD009178. doi: 10.1002/14651858.CD009178.pub4.

name: Oxford Health NHS Foundation Trust; Banbury UK

family: McCleery

full_name: Jenny McCleery

given: Jenny

sequence: additional

name: Department of Psychiatry; Oxford University; Oxford UK

family: Sharpley

full_name: Ann L Sharpley

given: Ann L

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Leger D, Elbaz M, Dubois A, Rio S, Mezghiche H, Carita P, Stemmelin J, Strauss M. Alzheimer's Disease Severity is Not Significantly Associated with Short Sleep: Survey by Actigraphy on 208 Mild and Moderate Alzheimer's Disease Patients. J Alzheimers Dis. 2017;55(1):321-331.

lead_sponsor: Sanofi

location_country:
Italy
United States
Spain
Germany
France
Poland
Australia
Portugal
Canada

location_facility:
Investigational Site Number 724008
Investigational Site Number 276007
Investigational Site Number 840041
Investigational Site Number 124013
Investigational Site Number 276001
Investigational Site Number 124015
Investigational Site Number 124014
Investigational Site Number 250004
Investigational Site Number 250005
Investigational Site Number 380001
Investigational Site Number 124008
Investigational Site Number 250002
Investigational Site Number 840005
Investigational Site Number 840014
Investigational Site Number 124011
Investigational Site Number 250009
Investigational Site Number 840009
Investigational Site Number 840037
Investigational Site Number 124009
Investigational Site Number 124004
Investigational Site Number 840021
Investigational Site Number 250001
Investigational Site Number 380004
Investigational Site Number 616002
Investigational Site Number 840004
Investigational Site Number 840031
Investigational Site Number 840030
Investigational Site Number 036006
Investigational Site Number 840015
Investigational Site Number 036001
Investigational Site Number 840026
Investigational Site Number 276009
Investigational Site Number 616005
Investigational Site Number 840003
Investigational Site Number 616003
Investigational Site Number 036008
Investigational Site Number 036009
Investigational Site Number 250006
Investigational Site Number 724001
Investigational Site Number 840038
Investigational Site Number 036003
Investigational Site Number 036007
Investigational Site Number 840040
Investigational Site Number 840011
Investigational Site Number 616006
Investigational Site Number 250003
Investigational Site Number 840001
Investigational Site Number 840008
Investigational Site Number 124001
Investigational Site Number 840006
Investigational Site Number 840032
Investigational Site Number 840039
Investigational Site Number 124002
Investigational Site Number 250008
Investigational Site Number 380005
Investigational Site Number 616001
Investigational Site Number 840002
Investigational Site Number 840018
Investigational Site Number 380003
Investigational Site Number 036005
Investigational Site Number 724003
Investigational Site Number 620002
Investigational Site Number 036004
Investigational Site Number 276011
Investigational Site Number 276012
Investigational Site Number 276008
Investigational Site Number 840034
Investigational Site Number 124003
Investigational Site Number 840025
Investigational Site Number 620001
Investigational Site Number 036002
Investigational Site Number 380006
Investigational Site Number 840013
Investigational Site Number 380002
Investigational Site Number 840024
Investigational Site Number 124006
Investigational Site Number 724007
Investigational Site Number 840012
Investigational Site Number 124010
Investigational Site Number 250007
Investigational Site Number 724002
Investigational Site Number 616004


title: A Phase 3 Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Regimen in Virologically Suppressed, HIV-1 Infected Patients

summary:
The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment option to patients who wish to simplify dosing by reducing pill burden or to improve the tolerability of their treatment.

Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which participants will switch treatment regimens at the start of the study, and the Stay on Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their baseline regimen during the first 24 weeks of the study (designed to provide an initial active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit.

After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF STR per protocol before switching to a commercially available source.

lead_sponsor: Gilead Sciences

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

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Infectious Disease Specialists of Atlanta (IDSA)

location_facility: Azienda Ospedaliera San Paolo, Mallattie Infettive e Tropicali

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Johns Hopkins University School of Medicine

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: University of Bonn, Dep. of Internal Medicine I, HIV-Outpatient Clinic

location_facility: National Institute for Infectious Diseases "L. Spallanzani" IRCCS

location_facility: Dept. of Dermatology, Div. of Immunology,

location_facility: University Medical Center Hamburg - Eppendorf

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: 2.Interne Lungenabteilung Otto Wagner Spital

location_facility: Infectiologie - 7ème Ouest - CHU HOTEL DIEU

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: Downtown Infectious Disease Clinic - Univ of BC

location_facility: Clinical Alliance for Research & Education-Infectious Diseases, LLC (CARE-ID)

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Department of Infectious Diseases, Saint-Louis hospital

location_facility: La Playa Medical Group and Clinical Research

location_facility: University of South Florida - HIV Clinical Research Unit

location_facility: Hôpital Saint Antoine, Servuce de Maladies Infectieuses

location_facility: AIDS Healthcare Foundation-Research Center

location_facility: Chelsea and Westminster Hospital Foundation Trust

location_facility: University of Cologne, Department of Internal Medicine

location_facility: Archet 1 CHU de Nice - 6ème Niveau - Infectiology

location_facility: Tarrant County Infectious Diseases Associates

location_facility: Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive

location_facility: St. Joseph's Comprehensive Research Institute


title: A Phase III Randomized, Open-label Study Comparing GSK1120212 to Chemotherapy in Subjects With Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma

summary: This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Subjects who have received up to one prior regimen of chemotherapy in the advanced or metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1 randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy arm). The primary endpoint for the statistical analysis will be a comparison of progression free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have progression on chemotherapy will be offered the option to receive GSK1120212.

ReferenceType: background

ReferenceCitation: Flaherty KT, Robert C, Hersey P, Nathan P, Garbe C, Milhem M, Demidov LV, Hassel JC, Rutkowski P, Mohr P, Dummer R, Trefzer U, Larkin JM, Utikal J, Dreno B, Nyakas M, Middleton MR, Becker JC, Casey M, Sherman LJ, Wu FS, Ouellet D, Martin AM, Patel K, Schadendorf D; METRIC Study Group. Improved survival with MEK inhibition in BRAF-mutated melanoma. N Engl J Med. 2012 Jul 12;367(2):107-14. doi: 10.1056/NEJMoa1203421. Epub 2012 Jun 4.

ReferenceCitation: Robert C, Flaherty K, Nathan P, Hersey P, Garbe C, Milhem M, Demidov L, Mohr P, Hassel JC, Rutkowski P, Dummer R, Utikal J, Kiecker F, Larkin J, D'Amelio A Jr, Mookerjee B, Schadendorf D. Five-year outcomes from a phase 3 METRIC study in patients with BRAF V600 E/K-mutant advanced or metastatic melanoma. Eur J Cancer. 2019 Mar;109:61-69. doi: 10.1016/j.ejca.2018.12.015. Epub 2019 Jan 25.

family: Robert

full_name: Caroline Robert

given: Caroline

sequence: first

family: Flaherty

full_name: Keith Flaherty

given: Keith

family: Nathan

full_name: Paul Nathan

given: Paul

family: Hersey

full_name: Peter Hersey

given: Peter

family: Garbe

full_name: Claus Garbe

given: Claus

family: Milhem

full_name: Mohammed Milhem

given: Mohammed

family: Demidov

full_name: Lev Demidov

given: Lev

family: Mohr

full_name: Peter Mohr

family: Hassel

full_name: Jessica C. Hassel

given: Jessica C.

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

family: Utikal

full_name: Jochen Utikal

given: Jochen

family: Kiecker

full_name: Felix Kiecker

given: Felix

family: Larkin

full_name: James Larkin

given: James

family: D'Amelio

full_name: Anthony D'Amelio

given: Anthony

suffix: Jr.

family: Mookerjee

full_name: Bijoyesh Mookerjee

given: Bijoyesh

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Five-year outcomes from a phase 3 METRIC study in patients with BRAF V600 E/K–mutant advanced or metastatic melanoma

ReferenceCitation: Latimer NR, Bell H, Abrams KR, Amonkar MM, Casey M. Adjusting for treatment switching in the METRIC study shows further improved overall survival with trametinib compared with chemotherapy. Cancer Med. 2016 May;5(5):806-15. doi: 10.1002/cam4.643. Epub 2016 Jan 27.

name: School of Health and Related Research University of Sheffield  Sheffield United Kingdom

family: Latimer

full_name: Nicholas R. Latimer

given: Nicholas R.

family: Bell

full_name: Helen Bell

given: Helen

name: Department of Health Sciences University of Leicester  Leicester United Kingdom

family: Abrams

full_name: Keith R. Abrams

given: Keith R.

name: Novartis Pharmaceuticals Corporation  East Hanover New Jersey

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

repository_institution: University of Leicester - Leicester Research Archive

ReferenceCitation: Santiago-Walker A, Gagnon R, Mazumdar J, Casey M, Long GV, Schadendorf D, Flaherty K, Kefford R, Hauschild A, Hwu P, Haney P, O'Hagan A, Carver J, Goodman V, Legos J, Martin AM. Correlation of BRAF Mutation Status in Circulating-Free DNA and Tumor and Association with Clinical Outcome across Four BRAFi and MEKi Clinical Trials. Clin Cancer Res. 2016 Feb 1;22(3):567-74. doi: 10.1158/1078-0432.CCR-15-0321. Epub 2015 Oct 7.

publisher: American Association for Cancer Research (AACR)

ReferenceCitation: Schadendorf D, Amonkar MM, Milhem M, Grotzinger K, Demidov LV, Rutkowski P, Garbe C, Dummer R, Hassel JC, Wolter P, Mohr P, Trefzer U, Lefeuvre-Plesse C, Rutten A, Steven N, Ullenhag G, Sherman L, Wu FS, Patel K, Casey M, Robert C. Functional and symptom impact of trametinib versus chemotherapy in BRAF V600E advanced or metastatic melanoma: quality-of-life analyses of the METRIC study. Ann Oncol. 2014 Mar;25(3):700-706. doi: 10.1093/annonc/mdt580. Epub 2014 Feb 6.

repositories_institution:
PubMed Central - Europe PMC
reroDoc Digital Library

location_country:
Italy
Austria
Sweden
Switzerland
Germany
France
Czechia
Greece
Poland
Norway
Argentina
Australia
Belgium
New Zealand
Russian Federation
United States
United Kingdom
Canada
Ukraine


title: A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

summary: The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.

ReferenceCitation: Sarrazin C, Dierynck I, Cloherty G, Ghys A, Janssen K, Luo D, Witek J, Buti M, Picchio G, De Meyer S. An OPTIMIZE study retrospective analysis for management of telaprevir-treated hepatitis C virus (HCV)-infected patients by use of the Abbott RealTime HCV RNA assay. J Clin Microbiol. 2015 Apr;53(4):1264-9. doi: 10.1128/JCM.03030-14. Epub 2015 Feb 4.

family: Sarrazin

full_name: Christoph Sarrazin

given: Christoph

family: Dierynck

full_name: Inge Dierynck

given: Inge

family: Cloherty

full_name: Gavin Cloherty

given: Gavin

family: Ghys

full_name: Anne Ghys

given: Anne

family: Janssen

full_name: Katrien Janssen

given: Katrien

family: Luo

full_name: Donghan Luo

given: Donghan

family: Witek

full_name: James Witek

family: Buti

full_name: Maria Buti

given: Maria

family: Picchio

full_name: Gaston Picchio

given: Gaston

family: De Meyer

full_name: Sandra De Meyer

given: Sandra

journal_name: Journal of Clinical Microbiology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

title: An OPTIMIZE Study Retrospective Analysis for Management of Telaprevir-Treated Hepatitis C Virus (HCV)-Infected Patients by Use of the Abbott RealTime HCV RNA Assay

ReferenceCitation: Buti M, Agarwal K, Horsmans Y, Sievert W, Janczewska E, Zeuzem S, Nyberg L, Brown RS Jr, Hézode C, Rizzetto M, Paraná R, De Meyer S, De Masi R, Luo D, Bertelsen K, Witek J. Telaprevir twice daily is noninferior to telaprevir every 8 hours for patients with chronic hepatitis C. Gastroenterology. 2014 Mar;146(3):744-753.e3. doi: 10.1053/j.gastro.2013.11.047. Epub 2013 Dec 4.

family: Agarwal

full_name: Kosh Agarwal

given: Kosh

family: Horsmans

full_name: Yves Horsmans

given: Yves

family: Sievert

full_name: William Sievert

given: William

family: Janczewska

full_name: Ewa Janczewska

given: Ewa

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

title: Telaprevir Twice Daily Is Noninferior to Telaprevir Every 8 Hours for Patients With Chronic Hepatitis C

location_country:
Austria
Brazil
Sweden
Mexico
Germany
France
Poland
Ireland
Australia
Belgium
Spain
United States
United Kingdom


title: A Placebo Controlled, Multicenter, Randomized Double Blind Trial to Evaluate the Safety and Effectiveness of IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction

summary: The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for the prevention of ventricular remodeling and congestive heart failure when administered to subjects who had successful percutaneous coronary intervention with stent placement after ST segment elevation MI (STEMI).

primary_purpose: Prevention

ReferenceCitation: Rao SV, Zeymer U, Douglas PS, Al-Khalidi H, White JA, Liu J, Levy H, Guetta V, Gibson CM, Tanguay JF, Vermeersch P, Roncalli J, Kasprzak JD, Henry TD, Frey N, Kracoff O, Traverse JH, Chew DP, Lopez-Sendon J, Heyrman R, Krucoff MW. Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction. J Am Coll Cardiol. 2016 Aug 16;68(7):715-23. doi: 10.1016/j.jacc.2016.05.053.

family: Rao

full_name: Sunil V. Rao

given: Sunil V.

family: Zeymer

full_name: Uwe Zeymer

given: Uwe

family: Douglas

full_name: Pamela S. Douglas

given: Pamela S.

family: Al-Khalidi

full_name: Hussein Al-Khalidi

given: Hussein

family: White

full_name: Jennifer A. White

given: Jennifer A.

family: Liu

full_name: Jingyu Liu

given: Jingyu

family: Levy

full_name: Howard Levy

given: Howard

family: Guetta

full_name: Victor Guetta

given: Victor

family: Gibson

full_name: C. Michael Gibson

given: C. Michael

family: Tanguay

full_name: Jean-Francois Tanguay

given: Jean-Francois

family: Vermeersch

full_name: Paul Vermeersch

given: Paul

family: Roncalli

full_name: Jérôme Roncalli

given: Jérôme

family: Kasprzak

full_name: Jaroslaw D. Kasprzak

given: Jaroslaw D.

family: Henry

full_name: Timothy D. Henry

given: Timothy D.

family: Frey

full_name: Norbert Frey

given: Norbert

family: Kracoff

full_name: Oscar Kracoff

given: Oscar

family: Traverse

full_name: Jay H. Traverse

given: Jay H.

family: Chew

full_name: Derek P. Chew

given: Derek P.

family: Lopez-Sendon

full_name: Jose Lopez-Sendon

given: Jose

family: Heyrman

full_name: Reinilde Heyrman

given: Reinilde

family: Krucoff

full_name: Mitchell W. Krucoff

given: Mitchell W.

journal_name: Journal of the American College of Cardiology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Frey N, Linke A, Süselbeck T, Müller-Ehmsen J, Vermeersch P, Schoors D, Rosenberg M, Bea F, Tuvia S, Leor J. Intracoronary delivery of injectable bioabsorbable scaffold (IK-5001) to treat left ventricular remodeling after ST-elevation myocardial infarction: a first-in-man study. Circ Cardiovasc Interv. 2014 Dec;7(6):806-12. doi: 10.1161/CIRCINTERVENTIONS.114.001478. Epub 2014 Oct 28.

name: From the Universitätsklinikum Schleswig-Holstein, Campus Kiel Klinik für Kardiologie und Angiologie, Kiel, Germany (N.F., M.R.); Department of Internal Medicine/Cardiology, University of Leipzig, Heart Center, Leipzig, Germany (A.L.); Medizinische Klinik Kardiologie, Angiologie, Pneumologie Internische Intensivmedizin Hämostasiologie, Mannheim, Germany (T.S.); Department of Internal Medicine III, Heart Center, University of Cologne, Cologne, Germany (J.M.-E.); AZ Middelheim Cardiology, Antwerpen,...

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Intracoronary Delivery of Injectable Bioabsorbable Scaffold (IK-5001) to Treat Left Ventricular Remodeling After ST-Elevation Myocardial Infarction

location_country:
United States
Germany
France
Poland
Israel
Belgium
Australia
Spain
Canada

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Hospital Clinico de Santiago de Compostela

location_facility: I Klinika Kardiologii i Elektrokardiologii lnterwencyjnej oraz Nadcisnienia Tetniczego CM UJ

location_facility: Oddzial Kardiologiczny Wojewodzki Specjalistyczny Szpital im. Bieganskiego w Lodzi

location_facility: Krankenhaus Barmherzige Brüder Abt.Kardiologie und Pneumologie

location_facility: Queen Elizabeth II Health Science Centre

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Klinik fur Kardiologie and Angiologie Universitatsklinikum

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Vivantes Netzwerk fur Gesundheit GmbH, Kinikum Neukolln

location_facility: Stadtische Kliniken Neuss - Lukaskrankenhaus

location_facility: Carl and Edyth Lindner Center for Research and Education @ Christ Hospital

location_facility: Centrum Interwencyjnego Leczenia Chorob Serca i Naczyn z Pododdzialem Kardiologii Interwencyjnej

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Centre Hospitalier Universitaire de Nice Hopital Pasteur

location_facility: Samodzileny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Hadassah University Medical Center Jerusalem-Cardiology

location_facility: Royal Perth Hospital - Dept. of Cardiology

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Universitatsklinikum Jena, Klinik fur Innere Medizin, Kardiologie

location_facility: Montefiore Medical Center Weiler Division

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM w Szczecinie


ReferenceType: result

ReferenceCitation: Cortes JE, Kim DW, Pinilla-Ibarz J, le Coutre PD, Paquette R, Chuah C, Nicolini FE, Apperley JF, Khoury HJ, Talpaz M, DeAngelo DJ, Abruzzese E, Rea D, Baccarani M, Müller MC, Gambacorti-Passerini C, Lustgarten S, Rivera VM, Haluska FG, Guilhot F, Deininger MW, Hochhaus A, Hughes TP, Shah NP, Kantarjian HM. Ponatinib efficacy and safety in Philadelphia chromosome-positive leukemia: final 5-year results of the phase 2 PACE trial. Blood. 2018 Jul 26;132(4):393-404. doi: 10.1182/blood-2016-09-739086. Epub 2018 Mar 22.

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

family: Cortes

full_name: Jorge E. Cortes

given: Jorge E.

name: Seoul St. Mary’s Hospital, Leukemia Research Institute, The Catholic University of Korea, Seoul, South Korea;

family: Kim

full_name: Dong-Wook Kim

given: Dong-Wook

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

family: Pinilla-Ibarz

full_name: Javier Pinilla-Ibarz

given: Javier

name: Charité, Universitätsmedizin Berlin, Berlin, Germany;

family: le Coutre

full_name: Philipp D. le Coutre

given: Philipp D.

name: Cedars-Sinai Medical Center, Los Angeles, CA;

family: Paquette

full_name: Ronald Paquette

given: Ronald

name: Singapore General Hospital, Duke–National University of Singapore (NUS) Medical School, Singapore;

family: Chuah

full_name: Charles Chuah

given: Charles

name: Centre Hospitalier Lyon-Sud, Pierre-Bénite, Lyon, France;

family: Nicolini

full_name: Franck E. Nicolini

given: Franck E.

name: Centre for Haematology, Imperial College, London, United Kingdom;

family: Apperley

full_name: Jane F. Apperley

given: Jane F.

name: Winship Cancer Institute of Emory University, Atlanta, GA;

family: Khoury

full_name: H. Jean Khoury

given: H. Jean

name: Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI;

family: Talpaz

full_name: Moshe Talpaz

given: Moshe

name: Dana-Farber Cancer Institute, Boston, MA;

family: DeAngelo

full_name: Daniel J. DeAngelo

given: Daniel J.

name: S. Eugenio Hospital, Tor Vergata University, Rome, Italy;

family: Abruzzese

full_name: Elisabetta Abruzzese

given: Elisabetta

name: Service d’Hématologie Adulte et Centre d’Investigation Clinique, Hôpital Saint Louis, Paris, France;

family: Rea

full_name: Delphine Rea

given: Delphine

name: Department of Experimental, Diagnostic, and Specialty Medicine, University of Bologna, Bologna, Italy;

family: Baccarani

full_name: Michele Baccarani

given: Michele

name: III. Medizinische Klinik, Universitätsmedizin Mannheim, Mannheim, Germany;

family: Müller

full_name: Martin C. Müller

given: Martin C.

name: University of Milano-Bicocca/San Gerardo Hospital, Monza, Italy;

family: Gambacorti-Passerini

full_name: Carlo Gambacorti-Passerini

given: Carlo

name: ARIAD Pharmaceuticals, Inc., Cambridge, MA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited;

family: Lustgarten

full_name: Stephanie Lustgarten

given: Stephanie

family: Rivera

full_name: Victor M. Rivera

given: Victor M.

family: Haluska

full_name: Frank G. Haluska

given: Frank G.

name: Centre d’Investigation Clinique (CIC) 1402, INSERM, Poitiers, France;

name: Centre Hospitalier Universitaire de Poitiers, Poitiers, France;

family: Guilhot

full_name: François Guilhot

given: François

name: Huntsman Cancer Institute, University of Utah, Salt Lake City, UT;

family: Deininger

full_name: Michael W. Deininger

given: Michael W.

name: Hematology/Oncology, Jena University Hospital, Jena, Germany;

family: Hochhaus

full_name: Andreas Hochhaus

given: Andreas

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

family: Hughes

full_name: Timothy P. Hughes

given: Timothy P.

name: Department of Medicine, Division of Hematology and Oncology, University of California San Francisco, San Francisco, CA

family: Shah

full_name: Neil P. Shah

given: Neil P.

family: Kantarjian

full_name: Hagop M. Kantarjian

given: Hagop M.

title: Ponatinib efficacy and safety in Philadelphia chromosome–positive leukemia: final 5-year results of the phase 2 PACE trial

ReferenceCitation: Cortes JE, Kim DW, Pinilla-Ibarz J, le Coutre P, Paquette R, Chuah C, Nicolini FE, Apperley JF, Khoury HJ, Talpaz M, DiPersio J, DeAngelo DJ, Abruzzese E, Rea D, Baccarani M, Müller MC, Gambacorti-Passerini C, Wong S, Lustgarten S, Rivera VM, Clackson T, Turner CD, Haluska FG, Guilhot F, Deininger MW, Hochhaus A, Hughes T, Goldman JM, Shah NP, Kantarjian H; PACE Investigators. A phase 2 trial of ponatinib in Philadelphia chromosome-positive leukemias. N Engl J Med. 2013 Nov 7;369(19):1783-96. doi: 10.1056/NEJMoa1306494. Epub 2013 Nov 1.

title: A Phase 2 Trial of Ponatinib in Philadelphia Chromosome–Positive Leukemias

ReferenceCitation: O'Hare T, Zabriskie MS, Eiring AM, Deininger MW. Pushing the limits of targeted therapy in chronic myeloid leukaemia. Nat Rev Cancer. 2012 Jul 24;12(8):513-26. doi: 10.1038/nrc3317. Review. Erratum in: Nat Rev Cancer. 2012 Dec;12(12):886.

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

location_country:
Italy
Sweden
Netherlands
France
Singapore
Belgium
Australia
Spain
Germany
United Kingdom
Korea, Republic of

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

title: A Pivotal Phase 2 Trial of Ponatinib (AP24534) in Patients With Refractory Chronic Myeloid Leukemia and Ph+ Acute Lymphoblastic Leukemia

summary: The purpose of this study is to determine the efficacy of ponatinib in patients with chronic myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or intolerant to either dasatinib or nilotinib, or have the (T)hreonine-315-(I)soleucine (T315I) mutation.


ReferenceCitation: Domachowske JB, Pankow-Culot H, Bautista M, Feng Y, Claeys C, Peeters M, Innis BL, Jain V. A randomized trial of candidate inactivated quadrivalent influenza vaccine versus trivalent influenza vaccines in children aged 3-17 years. J Infect Dis. 2013 Jun 15;207(12):1878-87. doi: 10.1093/infdis/jit091. Epub 2013 Mar 7.

family: Domachowske

full_name: Joseph B. Domachowske

given: Joseph B.

family: Pankow-Culot

full_name: Heidemarie Pankow-Culot

given: Heidemarie

family: Bautista

full_name: Milagros Bautista

given: Milagros

family: Feng

full_name: Yang Feng

given: Yang

family: Claeys

full_name: Carine Claeys

given: Carine

family: Peeters

full_name: Mathieu Peeters

given: Mathieu

family: Innis

full_name: Bruce L. Innis

given: Bruce L.

family: Jain

full_name: Varsha Jain

given: Varsha

journal_name: The Journal of Infectious Diseases

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: A Randomized Trial of Candidate Inactivated Quadrivalent Influenza Vaccine versus Trivalent Influenza Vaccines in Children Aged 3–17 Years

intervention_type: Biological

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.

location_country:
United States
Philippines
France
Czechia
Germany

acronym: FLU D-QIV-003

ipd_sharing: Yes

source: euctr

title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2321138A When Administered in Children

summary: This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals' investigational vaccine GSK2321138A in children aged 6 to 35 months.


title: A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR)

acronym: VALOR

summary: This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.

ReferenceCitation: Ravandi F, Ritchie EK, Sayar H, Lancet JE, Craig MD, Vey N, Strickland SA, Schiller GJ, Jabbour E, Erba HP, Pigneux A, Horst HA, Recher C, Klimek VM, Cortes J, Roboz GJ, Odenike O, Thomas X, Havelange V, Maertens J, Derigs HG, Heuser M, Damon L, Powell BL, Gaidano G, Carella AM, Wei A, Hogge D, Craig AR, Fox JA, Ward R, Smith JA, Acton G, Mehta C, Stuart RK, Kantarjian HM. Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukaemia (VALOR): a randomised, controlled, double-blind, multinational, phase 3 study. Lancet Oncol. 2015 Sep;16(9):1025-1036. doi: 10.1016/S1470-2045(15)00201-6. Epub 2015 Jul 30.

family: Ravandi

full_name: Farhad Ravandi

given: Farhad

family: Ritchie

full_name: Ellen K Ritchie

given: Ellen K

family: Sayar

full_name: Hamid Sayar

given: Hamid

family: Lancet

full_name: Jeffrey E Lancet

given: Jeffrey E

family: Craig

full_name: Michael D Craig

given: Michael D

family: Vey

full_name: Norbert Vey

given: Norbert

family: Strickland

full_name: Stephen A Strickland

given: Stephen A

family: Schiller

full_name: Gary J Schiller

given: Gary J

family: Jabbour

full_name: Elias Jabbour

given: Elias

family: Erba

full_name: Harry P Erba

given: Harry P

family: Pigneux

full_name: Arnaud Pigneux

given: Arnaud

family: Horst

full_name: Heinz-August Horst

given: Heinz-August

family: Recher

full_name: Christian Recher

given: Christian

family: Klimek

full_name: Virginia M Klimek

given: Virginia M

family: Cortes

full_name: Jorge Cortes

given: Jorge

family: Roboz

full_name: Gail J Roboz

given: Gail J

family: Odenike

full_name: Olatoyosi Odenike

given: Olatoyosi

family: Thomas

full_name: Xavier Thomas

given: Xavier

family: Havelange

full_name: Violaine Havelange

given: Violaine

family: Maertens

full_name: Johan Maertens

given: Johan

family: Derigs

full_name: Hans-Günter Derigs

given: Hans-Günter

family: Heuser

full_name: Michael Heuser

given: Michael

family: Damon

full_name: Lloyd Damon

given: Lloyd

ipd_sharing_description: De-identified data of individual participants experiencing Serious Adverse Events

location_country:
Italy
Austria
United States
Germany
France
Czechia
Poland
Hungary
Australia
Belgium
New Zealand
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Haematology Research, Auckland District Health Board, Auckland City Hospital

location_facility: Staedtisches Krankenhaus Kiel GmbH, Infektionsambulanz der 2. Medizinischen Klinik

location_facility: Service d'hematologie- Hopital Purpan- CHU de Toulouse

location_facility: Azienda Ospedaliero-Universitaria Maggiore Della Carita, Struttura Complessa Direzione Universitaria Ematologia

location_facility: University Hospital for Internal Medicine V, Innsbruck Medical University

location_facility: Department of Haematology, University Hospital of Wales

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen lll, Medizinische Klinik

location_facility: Hopital Avicenne- Departement Onco-hematologie

location_facility: Department of Clinical Haematology and BMT Service, Royal Melbourne Hospital

location_facility: Leicester Royal Infirmary, University Hospitals of Leicester, NHS Trust

location_facility: University of Iowa Hospitals and Clinics

location_facility: ZNA Stuivenberg, Lange Beeldekensstraat 267

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

location_facility: Rush University Medical Center, Division of Hematology/Oncology

location_facility: University Health Network, Princess Margaret Hospital

location_facility: Department of Haematology, Waikato Hospital

location_facility: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Hospital Universitari Politecnic la Fe Hematology Department

location_facility: Department of Haematology, Guy's Hospital

location_facility: George Washington University-Medical Faculty Associates

location_facility: HCA HealthONE - Rocky Mountain Blood and Marrow Transplant Program

location_facility: CHU Lille, Service des maladies du sang, Hopital Huriez

location_facility: Centro Oncologico MD Anderson International Espana

location_facility: Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital

location_facility: Division of Hematology, Vancouver General Hospital

location_facility: Centre Hospitalier Lyon Sud - Service d'Hematologie - Pavillon Marcel Berard - Bat. 1G - 1er etage, 165 Chemin du grand Revoyet

location_facility: AKH Wien / MedUniWien Universtatsklinik fur Innere Medizin 1

location_facility: Department of Haematology, Royal Liverpool University Hospital

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Klinikum St. Georg gGmbH; Klinik fur Internistische Onkologie/Hamatologie

location_facility: UZ Leuven, campus Gasthuisberg, Department of Haematology

location_facility: Regional Cancer Treatment Service, Palmerston North Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Fondazione IRCCS, Policlinico S. Matteo - Dipartimento di Ematologia

location_facility: SLK-Kliniken Heilbronn GmbH, Medizinische Klinik

location_facility: Haematology Department, Gosford Hospital

location_facility: North Shore Long Island Jewish Health System

location_facility: AORN "A. Cardarelli", U.O.S.C. Ematologia con TMO

location_facility: Ellis Fischel Cancer Center, University of Missouri Health Care

location_facility: Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust

location_facility: CHU Nantes Hotel Dieu, Service d'hematologie clinique

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: CHU Angers, Service des maladies du sang

location_facility: Fakultni nemocnice Brno, Interni hematoonkologicka klinika

location_facility: Central Manchester University Hospitals NHS Trust, Manchester Royal Infirmary

location_facility: Klinika Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego, Szpital Kliniczny Przemiemienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Dept. of Hematology, Asan Medical Center

location_facility: The University of Texas, M.D. Anderson Cancer Center, Department of Leukemia

location_facility: kaposi Mor Oktato Korhaz Belgyogyaszati Osztaly

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Landeskrankenhaus Salzburg, Universitaetsklinik fur innere Medizin lll, Universitaetsklinikum der PMU

location_facility: Universitatsklinikum Hamburg-Eppendorf; ll. Medizinische Klinik und Poliklinik; Onkologie, Hamatologie und Knochenmarktransplantation

location_facility: Szegedi Tudomanyegyetem, 11. Belgyogyaszati Klinika

location_facility: Universitatsklinik Graz, Universitatsklinik fur Innere Medizin, Abteilung fur Hamatologie

location_facility: Fakultni nemocnice Kralovske Vinohrady, Oddeleni klinicke hematologie

location_facility: New York Medical College, Division of Oncology/Hematology

location_facility: Klinikum Frankfurt am Main-Hochst, Department of Hematology and Oncology, Klinikum Frankfurt Academic Hospital of the University of Frankfurt

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University of Debrecen Medical and Health Sciences Center

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Ospedaliera Universitaria San Martino di Genova

location_facility: CHU de Bordeaux- Hopital Haut-Leveque, Centre Francois Magendle

location_facility: Fakultni nemocnice Hradec Kralove, 2. Interni klinika-oddeleni klinicke hematologie

location_facility: Medizinische Hochschule Hannover, Abteilung Hamatologie

location_facility: Queen's Centre for Oncology and Hematology, Castle Hill Hospital

location_facility: St. Francis Medical Group Oncology and Hematology Specialists

location_facility: Ospedale "A. Perrino", U.O. Compessa di Ematologia

location_facility: Andrew Love Cancer Center, Geelong Hospital, Barwon Health

location_facility: Azienda Ospedaliero-Universitaria Sant'Anna, Sezione di Ematologia, Dipartmento di Science Biomediche e Terapie Avanzate

location_facility: Department of Medicine Section of Hematology/Oncology, West Virginia University Hospitals, Mary Babb Randolph Cancer Center, West Virginia University


ReferenceCitation: Diéras V, Campone M, Yardley DA, Romieu G, Valero V, Isakoff SJ, Koeppen H, Wilson TR, Xiao Y, Shames DS, Mocci S, Chen M, Schmid P. Randomized, phase II, placebo-controlled trial of onartuzumab and/or bevacizumab in combination with weekly paclitaxel in patients with metastatic triple-negative breast cancer. Ann Oncol. 2015 Sep;26(9):1904-1910. doi: 10.1093/annonc/mdv263. Epub 2015 Jul 22.

family: Diéras

full_name: V. Diéras

given: V.

family: Campone

full_name: M. Campone

given: M.

family: Yardley

full_name: D.A. Yardley

family: Romieu

full_name: G. Romieu

given: G.

family: Valero

full_name: V. Valero

family: Isakoff

full_name: S.J. Isakoff

family: Koeppen

full_name: H. Koeppen

given: H.

family: Wilson

full_name: T.R. Wilson

family: Xiao

full_name: Y. Xiao

given: Y.

family: Shames

full_name: D.S. Shames

family: Mocci

full_name: S. Mocci

given: S.

family: Chen

full_name: M. Chen

family: Schmid

full_name: P. Schmid

given: P.

journal_name: Annals of Oncology

lead_sponsor: Genentech, Inc.

location_country:
United States
France
Belgium
Spain
Germany
United Kingdom

location_facility: Klinikum rechts der Isar der TU München; Frauenklinik

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Centre Francois Baclesse; Gastro-Enterologie

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

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

location_facility: Mount Vernon Hospital; Centre For Cancer Treatment

location_facility: Instituto Catalán de Oncología; Servicio de Farmacia

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Hospital Universitario Puerta del Mar; Servicio de Oncologia

location_facility: The Clatterbridge Cancer Ctr For Oncolgy

location_facility: Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia

location_facility: Sharp Healthcare; Oncology Research Program

location_facility: Can Care Assoc Med Group Inc; Beach Cities Offices

title: A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Patients With Metastatic, Triple-Negative Breast Cancer

summary: This is a randomized, Phase II, double-blind, multicenter, placebo-controlled trial designed to preliminarily estimate the efficacy and evaluate the safety and tolerability of onartuzumab (MetMAb) + bevacizumab + paclitaxel and onartuzumab + placebo + paclitaxel versus placebo + bevacizumab + paclitaxel in participants with metastatic or locally recurrent, triple-negative breast cancer who either have not received treatment (first-line) or have progressed after one conventional cytotoxic chemotherapy regimen (second-line).


title: A Double-blind, Randomized, Placebo-controlled Trial Evaluating The Safety And Efficacy Of Early Treatment With Eplerenone In Patients With Acute Myocardial Infarction

acronym: REMINDER

summary: Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction, in patients without heart failure, reduces cardiovascular mortality / morbidity.

ReferenceCitation: Montalescot G, Pitt B, Lopez de Sa E, Hamm CW, Flather M, Verheugt F, Shi H, Turgonyi E, Orri M, Vincent J, Zannad F; REMINDER Investigators; REMINDER Investigators. Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: the Randomized Double-Blind Reminder Study. Eur Heart J. 2014 Sep 7;35(34):2295-302. doi: 10.1093/eurheartj/ehu164. Epub 2014 Apr 29.

family: Montalescot

full_name: G. Montalescot

family: Pitt

full_name: B. Pitt

given: B.

family: Lopez de Sa

full_name: E. Lopez de Sa

given: E.

family: Hamm

full_name: C. W. Hamm

given: C. W.

family: Flather

full_name: M. Flather

family: Verheugt

full_name: F. Verheugt

given: F.

family: Shi

full_name: H. Shi

family: Turgonyi

full_name: E. Turgonyi

family: Orri

full_name: M. Orri

family: Vincent

full_name: J. Vincent

given: J.

family: Zannad

full_name: F. Zannad

family: Noll

full_name: G. Noll

family: Weir

full_name: R. Weir

given: R.

family: O'Neill

full_name: B. O'Neill

family: Bohm

full_name: M. Bohm

family: Hillis

full_name: W. S. Hillis

given: W. S.

family: Grieve

full_name: A. Grieve

given: A.

family: Rouleau

full_name: J.-L. Rouleau

family: Gerasimos

full_name: F. Gerasimos

family: Fitchett

full_name: D. Fitchett

given: D.

family: Lepage

full_name: S. Lepage

family: Madan

full_name: M. Madan

family: Sussex

full_name: B. Sussex

title: Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: The Randomized Double-Blind Reminder Study

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

location_country:
Netherlands
France
Czechia
Greece
Poland
Slovakia
Hungary
Spain
Germany
United Kingdom
Canada

location_facility: Vancouver General Hospital, Vancouver Coastal Health Authority

location_facility: Service Cardiologie, Centre Hospitalier de Cannes

location_facility: Walter C Mackenzie Health Sciences Centre (WCM)

location_facility: Nemocnice Na Homolce - kardiologicke oddeleni

location_facility: Universitaets-Herzzentrum Freiburg Bad Krozingen

location_facility: Sankt Johannes Hospital Medizinische Klinik I

location_facility: Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

location_facility: University Hospital of Leicester (UHL) NHS Trust

location_facility: HOSPITAL CLINICO SAN CARLOS- Universidad Complutense de Madrid

location_facility: Hospital General Universitario de Valencia

location_facility: Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny We Wroclawiu

location_facility: Blackpool Victoria Hospital NHS Trust , Cardiac Research ,Lancashire Cardiac Centre

location_facility: The Queens Medical Research Institute- University of Edinburgh

location_facility: Service Cardiologie Hopital Robert Boulin

location_facility: Josa Andras Oktato Korhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Kardiologia

location_facility: Hospital Del Sas de Jerez de La Frontera

location_facility: Georg-August-Universitaet Goettingen, Zentrum f. Innere Medizin / Kardiologie u. Pneumologie

location_facility: Chu Rangueil Service de Cardiologie, A - Bat H1

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: I. Interni klinika - kardiologie FN Olomouc

location_facility: Staedtisches Klinikum Muenchen GmbH Klinikum Neuperlach

location_facility: Petz Aladar Megyei Oktato Korhaz, Kardiologiai Osztaly

location_facility: General Hospital of Athens "Georgios Gennimatas"

location_facility: "Hospital Clinic i Provincial de Barcelona,Instituto Clinic del Torax

location_facility: University Hospitals Coventry and Warwickshire NHS Trust

location_facility: ECOGENE-21 / Centre de sante et de services sociaux de Chicoutimi

location_facility: Stredoslovensky ustav srdcovych a cievnych chorob, a.s.

location_facility: Vancouver General Hospital - Centennial Pavilion

location_facility: Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ w Oswiecimiu G.V.M CARINT Sp. zo.o.

location_facility: Katedra i Klinika Kardiologii i Chorob Wewnetrznych

location_facility: I.Interni klinika-kardiologie FN Olomouc

location_facility: Clinical Trials Unit, Morriston Hospital

location_facility: Narodny ustav srdcovych a cievnych chorob, a.s.

location_facility: Onze Lieve Vrouwe Gasthuis, Locatie Oosterpark

location_facility: Hôpital Henri Mondor - Pysiologie explorations fonctionnelles

location_facility: Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleurimont

location_facility: Centre de Sante et de Services Sociaux de Chicoutimi (CSSSC) (Complexe Hospitalier de la Sagamie)


ReferenceCitation: Prünte C, Fajnkuchen F, Mahmood S, Ricci F, Hatz K, Studnička J, Bezlyak V, Parikh S, Stubbings WJ, Wenzel A, Figueira J; RETAIN Study Group. Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study. Br J Ophthalmol. 2016 Jun;100(6):787-95. doi: 10.1136/bjophthalmol-2015-307249. Epub 2015 Oct 9.

family: Prünte

full_name: Christian Prünte

given: Christian

family: Fajnkuchen

full_name: Franck Fajnkuchen

given: Franck

family: Mahmood

full_name: Sajjad Mahmood

given: Sajjad

family: Ricci

full_name: Federico Ricci

given: Federico

family: Hatz

full_name: Katja Hatz

given: Katja

family: Studnička

full_name: Jan Studnička

given: Jan

family: Bezlyak

full_name: Vladimir Bezlyak

given: Vladimir

family: Parikh

full_name: Soumil Parikh

given: Soumil

family: Stubbings

full_name: William John Stubbings

given: William John

family: Wenzel

full_name: Andreas Wenzel

given: Andreas

family: Figueira

full_name: João Figueira

given: João

journal_name: British Journal of Ophthalmology

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Oxford - Oxford Academic Notes & Queries

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Switzerland
Netherlands
Spain
United Kingdom
France
Poland
Greece
Hungary
Belgium
Ireland
Portugal
Czech Republic

acronym: RETAIN

title: A 2 Year Randomized, Single-masked, Multicenter, Controlled Phase IIIb Trial Assessing the Efficacy and Safety of 0.5 mg Ranibizumab in Two "Treat and Extend" Treatment Algorithms vs. 0.5 mg Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus

summary: The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment regimen.


title: A Phase III Multicenter, International, Randomized, Double-blind, Placebo-controlled Study of Doxorubicin Plus Palifosfamide-tris vs. Doxorubicin Plus Placebo in Patients With Front-line Metastatic Soft Tissue Sarcoma.

acronym: PICASSO III

summary: This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS).

ReferenceCitation: Ryan CW, Merimsky O, Agulnik M, Blay JY, Schuetze SM, Van Tine BA, Jones RL, Elias AD, Choy E, Alcindor T, Keedy VL, Reed DR, Taub RN, Italiano A, Garcia Del Muro X, Judson IR, Buck JY, Lebel F, Lewis JJ, Maki RG, Schöffski P. PICASSO III: A Phase III, Placebo-Controlled Study of Doxorubicin With or Without Palifosfamide in Patients With Metastatic Soft Tissue Sarcoma. J Clin Oncol. 2016 Nov 10;34(32):3898-3905. doi: 10.1200/JCO.2016.67.6684. Epub 2016 Sep 30.

name: Christopher W. Ryan, Oregon Health & Science University, Portland, OR; Ofer Merimsky, Sackler School of Medicine, Tel-Aviv, Israel; Mark Agulnik, Northwestern University, Chicago, IL; Jean-Yves Blay, Centre Léon Bérard, Lyon; Antoine Italiano, Institut Bergonié, Bordeaux, France; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Robin L. Jones and Ian R. Judson, The Royal Marsden Hospital, London, United Kingdom; Anthony D. Elias...

family: Ryan

full_name: Christopher W. Ryan

given: Christopher W.

family: Merimsky

full_name: Ofer Merimsky

given: Ofer

family: Agulnik

full_name: Mark Agulnik

given: Mark

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Schuetze

full_name: Scott M. Schuetze

given: Scott M.

family: Van Tine

full_name: Brian A. Van Tine

given: Brian A.

family: Jones

full_name: Robin L. Jones

given: Robin L.

family: Elias

full_name: Anthony D. Elias

given: Anthony D.

family: Choy

full_name: Edwin Choy

given: Edwin

family: Alcindor

full_name: Thierry Alcindor

given: Thierry

family: Keedy

full_name: Vicki L. Keedy

given: Vicki L.

family: Reed

full_name: Damon R. Reed

given: Damon R.

family: Taub

full_name: Robert N. Taub

given: Robert N.

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Garcia del Muro

full_name: Xavier Garcia del Muro

given: Xavier

family: Judson

full_name: Ian R. Judson

given: Ian R.

family: Buck

full_name: Jill Y. Buck

given: Jill Y.

family: Lebel

full_name: Francois Lebel

given: Francois

family: Lewis

full_name: Jonathan J. Lewis

given: Jonathan J.

family: Maki

full_name: Robert G. Maki

given: Robert G.

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

lead_sponsor: Ziopharm

location_country:
Guatemala
Romania
Belgium
Australia
Russian Federation
India
France
Panama
Poland
Argentina
Canada
Colombia
Chile
Singapore
Germany
United States
United Kingdom
Italy
Brazil
Israel
Spain

location_facility: University of Washington/Seattle Cancer Care Alliance

location_facility: Institution name: Hospital de Câncer de Barretos - Fundação PIOXII

location_facility: University of Arkansas for Medical Sciences

location_facility: Washington University School of Medicine

location_facility: The Royal Marsden NHS Foundation Trust Sarcoma

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: The Ohio State University Medical Center

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


ReferenceCitation: Cherney D, Lund SS, Perkins BA, Groop PH, Cooper ME, Kaspers S, Pfarr E, Woerle HJ, von Eynatten M. The effect of sodium glucose cotransporter 2 inhibition with empagliflozin on microalbuminuria and macroalbuminuria in patients with type 2 diabetes. Diabetologia. 2016 Sep;59(9):1860-70. doi: 10.1007/s00125-016-4008-2. Epub 2016 Jun 17.

family: Cherney

full_name: David Cherney

given: David

family: Lund

full_name: Søren S. Lund

given: Søren S.

family: Perkins

full_name: Bruce A. Perkins

given: Bruce A.

family: Groop

full_name: Per-Henrik Groop

given: Per-Henrik

family: Cooper

full_name: Mark E. Cooper

given: Mark E.

family: Kaspers

full_name: Stefan Kaspers

given: Stefan

family: Pfarr

full_name: Egon Pfarr

given: Egon

family: Woerle

full_name: Hans J. Woerle

given: Hans J.

family: von Eynatten

full_name: Maximilian von Eynatten

given: Maximilian

journal_name: Diabetologia

repository_institution: University of Helsinki - Helda

repository_normalized: HELDA - Digital Repository of the University of Helsinki

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Barnett AH, Mithal A, Manassie J, Jones R, Rattunde H, Woerle HJ, Broedl UC; EMPA-REG RENAL trial investigators. Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014 May;2(5):369-84. doi: 10.1016/S2213-8587(13)70208-0. Epub 2014 Jan 24.

family: Barnett

full_name: Anthony H Barnett

given: Anthony H

family: Mithal

full_name: Ambrish Mithal

given: Ambrish

family: Manassie

full_name: Jenny Manassie

given: Jenny

full_name: Russell Jones

given: Russell

family: Rattunde

full_name: Henning Rattunde

given: Henning

full_name: Hans J Woerle

given: Hans J

family: Broedl

full_name: Uli C Broedl

given: Uli C

journal_name: The Lancet Diabetes & Endocrinology

lead_sponsor: Boehringer Ingelheim

location_country:
South Africa
India
Hong Kong
Netherlands
Philippines
Spain
France
Malaysia
Poland
Slovakia
Russian Federation
Portugal
United States
United Kingdom
Canada

location_facility: 1245.36.74012 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34021 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91212 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10014 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44024 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10023 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.74011 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10007 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20023 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10011 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60008 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.35004 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60009 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.48002 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10002 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10018 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.48004 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91211 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.31009 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44018 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.35002 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.70004 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.85204 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33001 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34013 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60010 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.31004 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.31003 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60011 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.74007 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10012 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91203 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.63009 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.63007 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91210 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.48006 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33043 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10017 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91204 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.74013 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60005 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60004 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44026 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10015 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.76022 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.70006 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.63010 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20086 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.48003 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44012 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10019 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33036 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10013 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91205 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33042 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.70009 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34014 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44023 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33038 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20056 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20053 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91213 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44007 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.35001 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20055 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.63008 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.85205 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91209 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91208 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.74009 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33041 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.70011 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44001 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10006 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.70008 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44016 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.74008 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91214 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10004 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20051 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.76020 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.48007 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44010 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.85202 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91207 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.31017 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.85201 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.48005 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34016 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.48001 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44013 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91201 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60001 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.31015 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33040 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.31002 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20052 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.63006 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10005 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.70002 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20054 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10003 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.85206 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34020 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10008 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.35003 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10009 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.76021 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34012 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44036 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60003 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91215 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91202 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33044 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.31012 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60006 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34017 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20048 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10021 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34015 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91216 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33037 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34019 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60007 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44025 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34009 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.63005 Boehringer Ingelheim Investigational Site

title: A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control

summary: This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities.


title: Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus.

acronym: PROFILE 1014

summary: This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.

ReferenceCitation: Camidge DR, Kim EE, Usari T, Polli A, Lewis I, Wilner KD. Renal Effects of Crizotinib in Patients With ALK-Positive Advanced NSCLC. J Thorac Oncol. 2019 Jun;14(6):1077-1085. doi: 10.1016/j.jtho.2019.02.015. Epub 2019 Feb 26.

family: Camidge

full_name: D. Ross Camidge

given: D. Ross

family: Kim

full_name: Elizabeth E. Kim

given: Elizabeth E.

family: Usari

full_name: Tiziana Usari

given: Tiziana

family: Polli

full_name: Anna Polli

given: Anna

family: Lewis

full_name: Iona Lewis

given: Iona

family: Wilner

full_name: Keith D. Wilner

given: Keith D.

journal_name: Journal of Thoracic Oncology

ReferenceCitation: Wilner KD, Usari T, Polli A, Kim EE. Comparison of cardiovascular effects of crizotinib and chemotherapy in ALK-positive advanced non-small-cell lung cancer. Future Oncol. 2019 Apr;15(10):1097-1103. doi: 10.2217/fon-2018-0869. Epub 2019 Jan 17.

name: Pfizer Oncology, La Jolla, CA 92121, USA

full_name: Keith D Wilner

given: Keith D

full_name: Elizabeth E Kim

given: Elizabeth E

journal_name: Future Oncology

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ReferenceCitation: Solomon BJ, Kim DW, Wu YL, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Tang Y, Wilner KD, Blackhall F, Mok TS. Final Overall Survival Analysis From a Study Comparing First-Line Crizotinib Versus Chemotherapy in ALK-Mutation-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Aug 1;36(22):2251-2258. doi: 10.1200/JCO.2017.77.4794. Epub 2018 May 16.

name: Benjamin J. Solomon, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Dong-Wan Kim, Seoul National University Hospital, Seoul, Republic of Korea; Yi-Long Wu, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou; Tony S. Mok, The Chinese University of Hong Kong, Hong Kong, Special Administrative Region, People’s Republic of China; Kazuhiko Nakagawa, Kindai University Faculty of Medicine, Osaka, Japan; Tarek Mekhail, Florida Hospital, Orlando, FL; Enriqueta Felip,...

family: Solomon

full_name: Benjamin J. Solomon

given: Benjamin J.

full_name: Dong-Wan Kim

given: Dong-Wan

family: Wu

full_name: Yi-Long Wu

given: Yi-Long

family: Nakagawa

full_name: Kazuhiko Nakagawa

given: Kazuhiko

family: Mekhail

full_name: Tarek Mekhail

given: Tarek

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

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: Final Overall Survival Analysis From a Study Comparing First-Line Crizotinib Versus Chemotherapy in ALK-Mutation-Positive Non–Small-Cell Lung Cancer

ReferenceCitation: Yoneda KY, Scranton JR, Cadogan MA, Tassell V, Nadanaciva S, Wilner KD, Stollenwerk NS. Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced Non-Small Cell Lung Cancer: Independent Review of Four PROFILE Trials. Clin Lung Cancer. 2017 Sep;18(5):472-479. doi: 10.1016/j.cllc.2017.03.004. Epub 2017 Mar 14.

title: Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced Non–Small Cell Lung Cancer: Independent Review of Four PROFILE Trials

ReferenceCitation: Solomon BJ, Cappuzzo F, Felip E, Blackhall FH, Costa DB, Kim DW, Nakagawa K, Wu YL, Mekhail T, Paolini J, Tursi J, Usari T, Wilner KD, Selaru P, Mok TS. Intracranial Efficacy of Crizotinib Versus Chemotherapy in Patients With Advanced ALK-Positive Non-Small-Cell Lung Cancer: Results From PROFILE 1014. J Clin Oncol. 2016 Aug 20;34(24):2858-65. doi: 10.1200/JCO.2015.63.5888. Epub 2016 Mar 28.

name: Benjamin J. Solomon, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Federico Cappuzzo, Istituto Toscano Tumori, Livorno; Jolanda Paolini, Jennifer Tursi, and Tiziana Usari, Pfizer Oncology, Milan, Italy; Enriqueta Felip, Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona, Spain; Fiona H. Blackhall, The Christie Hospital and Institute of Cancer Sciences, Manchester University, Manchester, United Kingdom; Daniel B. Costa, Beth Israel Deaconess Center,...

title: Intracranial Efficacy of Crizotinib Versus Chemotherapy in Patients With Advanced ALK-Positive Non–Small-Cell Lung Cancer: Results From PROFILE 1014

ReferenceCitation: Solomon BJ, Mok T, Kim DW, Wu YL, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Iyer S, Reisman A, Wilner KD, Tursi J, Blackhall F; PROFILE 1014 Investigators. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014 Dec 4;371(23):2167-77. doi: 10.1056/NEJMoa1408440. Erratum in: N Engl J Med. 2015 Oct 15;373(16):1582.

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

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

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

title: First-Line Crizotinib versus Chemotherapy in ALK-Positive Lung Cancer

ReferenceCitation: Ou SH. Crizotinib: a drug that crystallizes a unique molecular subset of non-small-cell lung cancer. Expert Rev Anticancer Ther. 2012 Feb;12(2):151-62. doi: 10.1586/era.11.186. Review.

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Peru
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Taiwan
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India
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Singapore
Ireland
China
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United States
United Kingdom
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Austria
Brazil
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location_facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

location_facility: Helsingin yliopistollinen keskussairaala, Meilahden kolmiosairaala,Keuhkosairauksien poliklinikka

location_facility: Mount Vernon Hospital, Mount Vernon Cancer Centre

location_facility: Washington University Center for Advanced Medicine Infusion Center Pharmacy

location_facility: Chang Gung Medical Foundation, LinKou Branch

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: Kyiv City Clinical Oncologic Center/Department of Chemotherapy

location_facility: Shanghai Chest Hospital/Department of Pulmonary Medicine

location_facility: National Hospital Organization Yamaguchi-Ube Medical Center

location_facility: Charite - Universitaetsmedizin Berlin, Campus Mitte

location_facility: City Multiple-Discipline Clinical Hospital #4,

location_facility: Azienda Ospedaliera San Camillo Forlanini-Padiglione Flaiani

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Universitair Ziekenhuis Brussel / Medische Oncologie

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Institut universitaire de cardiologie et de pneumologie de Quebec (IUCPQ)

location_facility: Taichung Veterans General Hospital, Comprehensive Cancer Center

location_facility: Institut Jules Bordet, Centre des Tumeurs de l'ULB

location_facility: First Saint-Petersburg State Medical University n.a. I.P. Pavlov

location_facility: Unità Operativa di Oncologia Medica Azienda USL Città di Bologna

location_facility: Samara Regional Clinical Oncology Dispensary

location_facility: Oslo universitetssykehus HF - Radiumhospitalet

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location_facility: Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP

location_facility: UT Southwestern University Hospital - William P. Clements, Jr.

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

location_facility: Lviv State Oncologic Regional Treatment and Diagnostic Center

location_facility: APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques

location_facility: Hospital Clinico Universidad de Chile, Seccion de Oncologia

location_facility: Ospedale Civile Azienda USL Toscana Nord Ovest

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location_facility: Centre Hospitalier Universitaire de Liege

location_facility: City Multiple-Discipline Clinical Hospital #4

location_facility: Department of Pulmonary Diseases AZ Delta

location_facility: Tata Memorial Centre, Tata Memorial Hospital,

location_facility: Russian Scientific Center of Radiology and Surgical Technologies

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location_facility: National Hospital Organization Shikoku Cancer Center

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location_facility: Farmacia Istituto Europeo di Oncologia IRCCS, U.O. Farmacia

location_facility: Loma Linda University Cancer Center (LLUCC)-Schuman Pavilion

location_facility: Clinica Anglo Americana/Centro de Investigacion Oncologia CAA

location_facility: Struttura Operativa Complessa Oncologia Medica A Centro di Riferimento Oncologico

location_facility: Hospital Universitario Insular de Gran Canaria

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location_facility: The Gujarat Cancer & Research Institute (M.P Shah Cancer Hospital),

location_facility: Ospedale Niguarda Ca'Granda, Divisione Oncologia Medica Falck

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location_facility: Kyushu University Hospital Respiratory Medicine

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location_facility: SC Oncologia Medica, Ospedale Santa Maria della Misericordia

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location_facility: Russian Oncological Research Center N.N. Blokhin

location_facility: Hematology-Oncology Associates of Northern New Jersey

location_facility: Research Pharmacy, Georgetown University Medical Center

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location_facility: First Saint-Petersburg State Medical University n.a. I.P.

location_facility: Samsung Medical Center, Sungkyunkwan Univ. School of Medicine

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: R.S. McLaughlin Durham Regional Cancer Centre

location_facility: NHS Greater Glasgow and Clyde Health Board, Beatson West of Scotland Cancer Centre,