summary: This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously [IV] once every 2 week [q2w]) or the placebo arm, in combination with radiation therapy (total dose 60 Gray [Gy], administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared [mg/m^2] oral administration [po] daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks [q3w]) or placebo monotherapy continued. The time on study treatment was until disease progression.

ReferenceCitation: Hagiwara A, Schlossman J, Shabani S, Raymond C, Tatekawa H, Abrey LE, Garcia J, Chinot O, Saran F, Nishikawa R, Henriksson R, Mason WP, Wick W, Cloughesy TF, Ellingson BM. Incidence, molecular characteristics, and imaging features of "clinically-defined pseudoprogression" in newly diagnosed glioblastoma treated with chemoradiation. J Neurooncol. 2022 Sep;159(3):509-518. doi: 10.1007/s11060-022-04088-3. Epub 2022 Jul 17.

ReferenceCitation: Jiguet-Jiglaire C, Boissonneau S, Denicolai E, Hein V, Lasseur R, Garcia J, Romain S, Appay R, Graillon T, Mason W, Carpentier AF, Brandes AA, Ouafik L', Wick W, Baaziz A, Gigan JP, Arguello RJ, Figarella-Branger D, Chinot O, Tabouret E. Plasmatic MMP9 released from tumor-infiltrating neutrophils is predictive for bevacizumab efficacy in glioblastoma patients: an AVAglio ancillary study. Acta Neuropathol Commun. 2022 Jan 3;10(1):1. doi: 10.1186/s40478-021-01305-4.

ReferenceCitation: Chinot OL, Nishikawa R, Mason W, Henriksson R, Saran F, Cloughesy T, Garcia J, Revil C, Abrey L, Wick W. Upfront bevacizumab may extend survival for glioblastoma patients who do not receive second-line therapy: an exploratory analysis of AVAglio. Neuro Oncol. 2016 Sep;18(9):1313-8. doi: 10.1093/neuonc/now046. Epub 2016 Mar 22.

ReferenceCitation: Saran F, Chinot OL, Henriksson R, Mason W, Wick W, Cloughesy T, Dhar S, Pozzi E, Garcia J, Nishikawa R. Bevacizumab, temozolomide, and radiotherapy for newly diagnosed glioblastoma: comprehensive safety results during and after first-line therapy. Neuro Oncol. 2016 Jul;18(7):991-1001. doi: 10.1093/neuonc/nov300. Epub 2016 Jan 24.

ReferenceCitation: Taphoorn MJ, Henriksson R, Bottomley A, Cloughesy T, Wick W, Mason WP, Saran F, Nishikawa R, Hilton M, Theodore-Oklota C, Ravelo A, Chinot OL. Health-Related Quality of Life in a Randomized Phase III Study of Bevacizumab, Temozolomide, and Radiotherapy in Newly Diagnosed Glioblastoma. J Clin Oncol. 2015 Jul 1;33(19):2166-75. doi: 10.1200/JCO.2014.60.3217. Epub 2015 May 26.

ReferenceCitation: Chinot OL, Wick W, Mason W, Henriksson R, Saran F, Nishikawa R, Carpentier AF, Hoang-Xuan K, Kavan P, Cernea D, Brandes AA, Hilton M, Abrey L, Cloughesy T. Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):709-22. doi: 10.1056/NEJMoa1308345.

repositories_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Chinot OL, Macdonald DR, Abrey LE, Zahlmann G, Kerloeguen Y, Cloughesy TF. Response assessment criteria for glioblastoma: practical adaptation and implementation in clinical trials of antiangiogenic therapy. Curr Neurol Neurosci Rep. 2013 May;13(5):347. doi: 10.1007/s11910-013-0347-2.

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Institution of Higher Professional Learning Military; Neurooncology

location_facility: Hiroshima University Hospital; Neurosurgery

location_facility: Uni Klinikum München - Großhardern; Med. Klinik U. Poliklinik III - Abt. Onkologie u. Hämatologie

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Hadassah Hebrew University Hospital; Leslie and Michael Gaffin Center for Neuro-Oncology

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Institut Oncologic Ion Chiricuta; Departament Radioterapie

location_facility: Norrlands Universitetssjukhus; Cancer Centrum

location_facility: Centre Val Aurelle Paul Lamarque; Medecine B3

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

location_facility: Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi

location_facility: BC Cancer Agency, Vancouver Clinic; Dept. of Medical Oncology

location_facility: The Royal Marsden NHS Foundation Trust; Oncology

location_facility: Universitatsklinikum Heidelberg; Abteilung Neuroonkologie

location_facility: Yonsei University Severance Hospital; Medical Oncology

location_facility: Calvary North Adelaide; North Adeliade Oncology Centre

location_facility: Universitatsklinikum Hamburg-Eppendorf; Klinik und Poliklinik fur Neurochirurgie

location_facility: Institut Oncologic Prof. Dr. Alexandru Trestioreanu; Departament Radioterapie

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: Catharina Ziekenhuis; Dept of Internal Medicin

location_facility: Utrecht University Medical Centre; Dept of Medical Oncology and UPC

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica

location_facility: Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.

location_facility: Queen Elizabeth Medical Centre; Neurosurgery

location_facility: Princess AleXandra Hospital; Department of Medical Oncology

location_facility: University of Alabama At Birmingham; Neuro-Oncology

location_facility: The Clatterbridge Cancer Ctr For Oncolgy

location_facility: Russian Research Oncology Center n.a. N.N. Blokhin of the RAMS; Department of Neurosurgery

location_facility: Chaim Sheba MC; Pediatric Hematology Oncology

location_facility: Scientific Research Neurosurgery Institute; Dept. of Neurooncology

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Hospital de Sao Joao; Servico de Oncologia

location_facility: Justus-Liebig-Universität Giessen; Neurochirurgische Klinik

location_facility: University Hospital of Larissa; Oncology

location_facility: McGill University; Montreal Neurological Institute; Oncology

location_facility: Az. Osp. S. Maria; Dept. Di Oncologia Medica

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Pusan National University Hospital; Neuro Sugery

location_facility: Hôpital Central; Departement de Neuro-Oncologie

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Royal Melbourne Hospital; Hematology and Medical Oncology

location_facility: Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage

location_facility: Kyungpook National University Hosital; Neuro Sugery

location_facility: Saskatoon Cancer Centre; Uni of Saskatoon Campus

location_facility: Ospedale di Treviso, Universita di Padova; Neurosurgery Dept

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Neurochirurgie

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház; Neurosurgery

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

location_facility: North Shore Private Hospital; Northern Specialist Centre

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: Royal North Shore Hospital; Department of Medical Oncology

location_facility: National Cancer Center Hospital; Neurosurgery

location_facility: Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin

location_facility: Princess Margaret Hospital; Pencer Brain Tumour Centre, 18-727

location_facility: Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica

location_facility: Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale

location_facility: Chonnam National University Hwasun Hospital

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Waikato Hospital; Regional Cancer Center

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Ottawa Hospital Regional Cancer Centre; Neuro-Oncology

location_facility: Saitama Medical University International Medical Center; Clinical and Medical Oncology

location_facility: National Cancer Centre; Neurosurgery Dept

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr

location_facility: Northern Centre for Cancer Care;Oncology

location_facility: Cancer Centre of Southeastern Ontario; Kingston General Hospital

location_facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

location_facility: Klinikum der Johannes Gutenberg Uni Mainz; Studienz. Neurologie, Klinik und Poliklinik Neurologie

location_facility: Samsung Medical Center; Neurosurgery Department

location_facility: Kyorin University Hospital; Neurosurgery

location_facility: Prince of Wales Hospital; Department of Medical Oncology

location_facility: Sarah Cannon Cancer Center and Research Institute

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: VU MEDISCH CENTRUM; Dept. of Medical Oncology

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Institut Bergonie; Gastro Enterologie Oncologie

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Pécsi Tudományegyetem Áok; Onkoterapias Intezet

location_facility: Kumamoto University Hospital; Neurosurgery

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Hong Kong Sanatorium & Hospital; Comprehensive Oncology Centre

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Bevacizumab, Temozolomide and Radiotherapy, Followed by Bevacizumab and Temozolomide Versus Placebo, Temozolomide and Radiotherapy Followed by Placebo and Temozolomide in Patients With Newly Diagnosed Glioblastoma

location_country:
Germany
Poland
New Zealand
Australia
Japan
Canada
France
Portugal
Hungary
Hong Kong
Denmark
Switzerland
United States
Romania
Belgium
Italy
United Kingdom
Sweden
Netherlands
Korea, Republic of
Spain
Greece
Russian Federation
Israel


study_start_date_type: Actual

acronym: SEARCH

intervention_type: Drug

lead_sponsor: Bayer

summary: This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.

status: Completed

title: A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Chile
Canada
France
Colombia
Hong Kong
United States
Belgium
China
Peru
Italy
United Kingdom
Singapore
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


title: Apixaban for Prevention of Acute Ischemic Events - 2 A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects With a Recent Acute Coronary Syndrome

summary: The purpose of this study is to determine if apixaban is superior to placebo for preventing cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a recent acute coronary syndrome

status: Terminated

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Sharma A, Hagstrom E, Wojdyla DM, Neely ML, Harrington RA, Wallentin L, Alexander JH, Goodman SG, Lopes RD; Apixaban for Prevention of Acute Ischemic Safety Events APPRAISE-2 Steering Committee and Investigators. Clinical consequences of bleeding among individuals with a recent acute coronary syndrome: Insights from the APPRAISE-2 trial. Am Heart J. 2019 Sep;215:106-113. doi: 10.1016/j.ahj.2019.05.004. Epub 2019 May 11.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Inohara T, Pieper K, Wojdyla DM, Patel MR, Jones WS, Tricoci P, Mahaffey KW, James SK, Alexander JH, Lopes RD, Wallentin L, Ohman EM, Roe MT, Vemulapalli S. Incidence, timing, and type of first and recurrent ischemic events in patients with and without peripheral artery disease after an acute coronary syndrome. Am Heart J. 2018 Jul;201:25-32. doi: 10.1016/j.ahj.2018.03.013. Epub 2018 Mar 28.

ReferenceCitation: Sherwood MW, Lopes RD, Sun JL, Liaw D, Harrington RA, Wallentin L, Laskowitz DT, James SK, Goodman SG, Darius H, Lewis BS, Gibson CM, Pieper KS, Alexander JH. Apixaban following acute coronary syndromes in patients with prior stroke: Insights from the APPRAISE-2 trial. Am Heart J. 2018 Mar;197:1-8. doi: 10.1016/j.ahj.2017.09.020. Epub 2017 Oct 24.

ReferenceCitation: Guimaraes PO, Lopes RD, Stevens SR, Zimerman A, Wruck L, James SK, Haque G, Giraldez RRCV, Alexander JH, Alexander KP. Reporting Clinical End Points and Safety Events in an Acute Coronary Syndrome Trial: Results With Integrated Collection. J Am Heart Assoc. 2017 Apr 24;6(4):e005490. doi: 10.1161/JAHA.117.005490.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

unpaywall_oa_status: gold

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Hess CN, James S, Lopes RD, Wojdyla DM, Neely ML, Liaw D, Hagstrom E, Bhatt DL, Husted S, Goodman SG, Lewis BS, Verheugt FWA, De Caterina R, Ogawa H, Wallentin L, Alexander JH. Apixaban Plus Mono Versus Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights From the APPRAISE-2 Trial. J Am Coll Cardiol. 2015 Aug 18;66(7):777-787. doi: 10.1016/j.jacc.2015.06.027.

ReferenceCitation: Khan R, Lopes RD, Neely ML, Stevens SR, Harrington RA, Diaz R, Cools F, Jansky P, Montalescot G, Atar D, Lopez-Sendon J, Flather M, Liaw D, Wallentin L, Alexander JH, Goodman SG; Apixaban for Prevention of Acute Ischemic Safety Events (APPRAISE)-2 Steering Committee and Investigators. Characterising and predicting bleeding in high-risk patients with an acute coronary syndrome. Heart. 2015 Sep;101(18):1475-84. doi: 10.1136/heartjnl-2014-307346. Epub 2015 Jun 24.

publisher_dissemination: British Medical Journal

ReferenceCitation: Mahaffey KW, Hager R, Wojdyla D, White HD, Armstrong PW, Alexander JH, Tricoci P, Lopes RD, Ohman EM, Roe MT, Harrington RA, Wallentin L. Meta-analysis of intracranial hemorrhage in acute coronary syndromes: incidence, predictors, and clinical outcomes. J Am Heart Assoc. 2015 Jun 18;4(6):e001512. doi: 10.1161/JAHA.114.001512.

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

ReferenceCitation: Alexander JH, Lopes RD, James S, Kilaru R, He Y, Mohan P, Bhatt DL, Goodman S, Verheugt FW, Flather M, Huber K, Liaw D, Husted SE, Lopez-Sendon J, De Caterina R, Jansky P, Darius H, Vinereanu D, Cornel JH, Cools F, Atar D, Leiva-Pons JL, Keltai M, Ogawa H, Pais P, Parkhomenko A, Ruzyllo W, Diaz R, White H, Ruda M, Geraldes M, Lawrence J, Harrington RA, Wallentin L; APPRAISE-2 Investigators. Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med. 2011 Aug 25;365(8):699-708. doi: 10.1056/NEJMoa1105819. Epub 2011 Jul 24.

lead_sponsor: Bristol-Myers Squibb

collaborators:
Pfizer
Duke Clinical Research Institute

sponsor_collaborators:
Bristol-Myers Squibb
Pfizer
Duke Clinical Research Institute

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Chile
Canada
France
Czech Republic
Colombia
Slovakia
Hungary
Denmark
Switzerland
United States
Ukraine
India
Romania
Belgium
China
Peru
Puerto Rico
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation
Israel

location_facility: Cincinnati Veterans Affairs Medical Center

location_facility: University Of Mississippi Medical Center

location_facility: Bermisa Family Practice & Research Center

location_facility: Richard M. Kastelic M.D. & Associates, P.C.

location_facility: East Carolina Heart Institute At East Carolina University

location_facility: Methodist Debakey Heart & Vascular Center

location_facility: University Of Oklahoma Health Sciences Center

location_facility: Alegent Health Clinic Heart & Vascular Specialists

location_facility: Alta Pharmaceutical Research Center, Inc.

location_facility: Cardiology Assoicates, Pc/Black Hills Clinical Research Ctr

location_facility: Washington University School Of Medicine

location_facility: Central Cardiovascular Institute Of San Antonio

location_facility: Amarillo Heart Clinical Research Institute Inc.

location_facility: Dr Kiran C Patel Research Institute At Pepin Heart Hospital

location_facility: Sendara Cardiovasular Research Institute

location_facility: Centex Research, Pineloch Medical Clinic

location_facility: The Heart And Vascular Institute Of Florida

location_facility: Cardiovascular Specialist Of South Florida

location_facility: Indian River Cardiovascular Associates, Inc

location_facility: Consultants In Cardiovascular Diseases, Inc.

location_facility: Cardiology Associates Of Southeastern Ohio

location_facility: Thoracic And Cardiovascular Healthcare Foundation

location_facility: Miami Cardiology Clinical Research, L.L.C.

location_facility: Texas Health Research & Education Institute

location_facility: Cardiovascular Research Institute Of Dallas

location_facility: Melbourne Internal Medicine Associates (Mima)

location_facility: Great Lakes Heart & Vascular Institute, Pc

location_facility: Wheaton Franciscan Healthcare St. Joseph

location_facility: Virgina Commonwealth Universitymedical Center

location_facility: Cardiology Partners Clinical Research Institute

location_facility: Jacksonville Center For Clinical Research

location_facility: Cardiovascular Physicians Of North Atlanta

location_facility: Louisiana State University Health Sciences Center-Shreveport

location_facility: Atlanta Institute For Medical Research, Inc

location_facility: The University Of North Carolina At Chapel Hill

status_simplified: Unknown


acronym: EMILIA

lead_sponsor: Hoffmann-La Roche

summary: This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.

ReferenceCitation: Dieras V, Miles D, Verma S, Pegram M, Welslau M, Baselga J, Krop IE, Blackwell K, Hoersch S, Xu J, Green M, Gianni L. Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):732-742. doi: 10.1016/S1470-2045(17)30312-1. Epub 2017 May 16. Erratum In: Lancet Oncol. 2017 Aug;18(8):e433. Lancet Oncol. 2018 Dec;19(12):e667.

oa_host_type: repository

version: acceptedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

ReferenceCitation: Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, Pegram M, Oh DY, Dieras V, Guardino E, Fang L, Lu MW, Olsen S, Blackwell K; EMILIA Study Group. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012 Nov 8;367(19):1783-91. doi: 10.1056/NEJMoa1209124. Epub 2012 Oct 1. Erratum In: N Engl J Med. 2013 Jun 20;368(25):2442.

ReferenceCitation: Scott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer. 2012 Mar 22;12(4):278-87. doi: 10.1038/nrc3236.

title: A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and Safety of Trastuzumab MCC-DM1 vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy

type: Other Identifier

location_country:
Finland
Germany
Poland
New Zealand
Brazil
Bosnia and Herzegovina
Canada
France
Slovenia
Colombia
Portugal
Hong Kong
Denmark
Switzerland
United States
India
Philippines
Italy
United Kingdom
Singapore
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Sweden


acronym: Not applicable

lead_sponsor: H. Lundbeck A/S

summary: The study will evaluate the long-term maintenance of efficacy of Lu AA21004 in patients with Generalized Anxiety Disorder (GAD) who responded to acute treatment with Lu AA21004.

ReferenceType: result

ReferenceCitation: Baldwin DS, Loft H, Florea I. Lu AA21004, a multimodal psychotropic agent, in the prevention of relapse in adult patients with generalized anxiety disorder. Int Clin Psychopharmacol. 2012 Jul;27(4):197-207. doi: 10.1097/YIC.0b013e3283530ad7.

ReferenceCitation: Christensen MC, Loft H, Florea I, McIntyre RS. Efficacy of vortioxetine in working patients with generalized anxiety disorder. CNS Spectr. 2019 Apr;24(2):249-257. doi: 10.1017/S1092852917000761. Epub 2017 Oct 30. Erratum In: CNS Spectr. 2019 Apr;24(2):275.

oa_host_type: publisher

evidence: open (via page says Open Access)

license: unspecified-oa

license_normalized: unspecified-oa

unpaywall_oa_status: hybrid

publisher_dissemination: Cambridge University Press

title: A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Lu AA21004 in Patients With Generalized Anxiety Disorder

location_country:
Finland
Colombia
Hungary
Argentina
Costa Rica
South Africa
Chile
Peru
Estonia
Russian Federation
France


summary: The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated

ReferenceCitation: Gore L, Kearns PR, de Martino ML, Lee, De Souza CA, Bertrand Y, Hijiya N, Stork LC, Chung NG, Cardos RC, Saikia T, Fagioli F, Seo JJ, Landman-Parker J, Lancaster D, Place AE, Rabin KR, Sacchi M, Swanink R, Zwaan CM. Dasatinib in Pediatric Patients With Chronic Myeloid Leukemia in Chronic Phase: Results From a Phase II Trial. J Clin Oncol. 2018 May 1;36(13):1330-1338. doi: 10.1200/JCO.2017.75.9597. Epub 2018 Mar 2.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_facility: Hospital Civil De Guadalajara - Nuevo Dr. Juan I. Menchaca

location_facility: Hospital Nacional Profesor Alejandro Posadas

location_facility: Children's Healthcare of Atlanta - Egleston Hospital

location_facility: Jonathan Jaques Children'S Cancer Center

location_facility: Children's Healthcare Of Atlanta - Egleston

status: Active, not recruiting

title: A Phase II Study of Dasatinib Therapy in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia or With Ph+ Leukemias Resistant or Intolerant to Imatinib

design_allocation: Non-Randomized

study_completion_date_type: Anticipated

location_country:
Germany
Italy
India
United Kingdom
Argentina
Romania
Australia
Brazil
Netherlands
Mexico
Singapore
United States
Korea, Republic of
Spain
South Africa
Canada
Russian Federation
France

status_simplified: Ongoing


title: A Randomised, Double-Blind, Single Dose, One-Day Early Administration, Multicentre Study Comparing the Efficacy and Safety of Acyclovir Lauriad® 50 mg Muco-adhesive Buccal Tablet to Matching Placebo, in the Treatment of Herpes Labialis in Immunocompetent Patients.

acronym: LIP

summary: To demonstrate the efficacy of a single dose of acyclovir Lauriad® 50mg muco-adhesive buccal tablet versus a single dose of matching placebo on the primary vesicular lesion of cold sore.

lead_sponsor: Valerio Therapeutics

location_country:
Germany
Poland
United Kingdom
Australia
United States
Czech Republic
France

location_facility: Specjalistyczne Gabinety Lekarskie Dermed

location_facility: Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska Medikard

location_facility: Central military hospital Dept. of Dermatology

location_facility: Naukowo-Badawczy i Naukowo-Dydaktyczny Ośrodek Dermatologii Estetycznej, Dermatochirurgii i Fotodermatologii

location_facility: General Teaching Hospital, Dep. Of Dermatology

location_facility: Hopital Fournier, Service de dermatologie

location_facility: NZOZ Praktyka Lekarska Iga Gilas - Mirkiewicz

location_facility: Hôpital L'Archet 2, Service de Dermatologie

location_facility: University Hospital Bulovka 3rd Clinic of Inf. Diseases

location_facility: University Hospital Bulovka Dept. of Dermatology

location_facility: Charité Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Klinik und Poliklinik für Dermatologie des Universitätsklinikums Bonn

location_facility: Clinvest, a Division of Banyan Group, Inc.,

location_facility: Hôpital Saint Louis Paris, Service de Dermatologie 1

location_facility: Hôpital St Jacques Service de Dermatologie

location_facility: Katedra i Klinika Dermatologii Collegium Medicum

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej GCP Dobra Praktyka Lekarska

location_facility: Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną

location_facility: Service de Stomatologie et chirurgie Maxilo-Faciale.Hôpital de la pitié Salpétrière


lead_sponsor: Gilead Sciences

summary: The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.

ReferenceCitation: Assael BM, Pressler T, Bilton D, Fayon M, Fischer R, Chiron R, LaRosa M, Knoop C, McElvaney N, Lewis SA, Bresnik M, Montgomery AB, Oermann CM; AZLI Active Comparator Study Group. Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial. J Cyst Fibros. 2013 Mar;12(2):130-40. doi: 10.1016/j.jcf.2012.07.006. Epub 2012 Sep 15.

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

sponsor_collaborators:
Gilead Sciences
Chiltern International Inc.
ClinPhone, Inc.
Covance

title: An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam for Inhalation Solution (AZLI) Versus Tobramycin Inhalation Solution (TIS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects With Cystic Fibrosis Followed by an Open-Label, Single Arm Extension (European Union [EU] Only)

location_country:
Germany
Ireland
Italy
Portugal
United Kingdom
Denmark
Netherlands
Austria
Belgium
Switzerland
United States
Spain
France


title: An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials

acronym: FUSE

summary: In studies of Exubera in persons with diabetes, lung cancer occurred in a few more people who were taking Exubera than in people who were taking other diabetes medicines. All subjects diagnosed with lung cancer had a history of smoking and the number of lung cancer cases observed fell within the expected range based on population-based data. There is currently not enough information to determine if any of the observed lung cancer cases were related to Exubera use, therefore, the study is being conducted to further investigate whether Exubera use makes the appearance of lung cancer more likely.

study_type: Observational

ReferenceCitation: Gatto NM, Koralek DO, Bracken MB, Duggan WT, Lem J, Klioze S, Koch GG, Wise RA, Cohen RB, Jackson NC. Lung Cancer-Related Mortality With Inhaled Insulin or a Comparator: Follow-Up Study of patients previously enrolled in Exubera Controlled Clinical Trials (FUSE) Final Results. Diabetes Care. 2019 Sep;42(9):1708-1715. doi: 10.2337/dc18-2529. Epub 2019 Jul 22.

publisher_dissemination: American Diabetes Association

lead_sponsor: Pfizer

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Croatia
Canada
France
Portugal
Slovakia
Denmark
United States
Belgium
Estonia
Italy
Norway
United Kingdom
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Sweden


title: A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Impact of Diamyd on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus (EU)

summary: The purpose of this study is to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes.

ReferenceCitation: Tavira B, Cheramy M, Axelsson S, Akerman L, Ludvigsson J, Casas R. Effect of simultaneous vaccination with H1N1 and GAD-alum on GAD65-induced immune response. Diabetologia. 2017 Jul;60(7):1276-1283. doi: 10.1007/s00125-017-4263-x. Epub 2017 Mar 29.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

repositories_concat: DiVA.org;PubMed Central

publisher_dissemination: Springer-Nature

ReferenceCitation: Ludvigsson J, Cheramy M, Axelsson S, Pihl M, Akerman L, Casas R; Clinical GAD-Study Group in Sweden. GAD-treatment of children and adolescents with recent-onset type 1 diabetes preserves residual insulin secretion after 30 months. Diabetes Metab Res Rev. 2014 Jul;30(5):405-14. doi: 10.1002/dmrr.2503.

publisher_dissemination: Wiley

ReferenceCitation: Ludvigsson J, Krisky D, Casas R, Battelino T, Castano L, Greening J, Kordonouri O, Otonkoski T, Pozzilli P, Robert JJ, Veeze HJ, Palmer J, Samuelsson U, Elding Larsson H, Aman J, Kardell G, Neiderud Helsingborg J, Lundstrom G, Albinsson E, Carlsson A, Nordvall M, Fors H, Arvidsson CG, Edvardson S, Hanas R, Larsson K, Rathsman B, Forsgren H, Desaix H, Forsander G, Nilsson NO, Akesson CG, Keskinen P, Veijola R, Talvitie T, Raile K, Kapellen T, Burger W, Neu A, Engelsberger I, Heidtmann B, Bechtold S, Leslie D, Chiarelli F, Cicognani A, Chiumello G, Cerutti F, Zuccotti GV, Gomez Gila A, Rica I, Barrio R, Clemente M, Lopez Garcia MJ, Rodriguez M, Gonzalez I, Lopez JP, Oyarzabal M, Reeser HM, Nuboer R, Stouthart P, Bratina N, Bratanic N, de Kerdanet M, Weill J, Ser N, Barat P, Bertrand AM, Carel JC, Reynaud R, Coutant R, Baron S. GAD65 antigen therapy in recently diagnosed type 1 diabetes mellitus. N Engl J Med. 2012 Feb 2;366(5):433-42. doi: 10.1056/NEJMoa1107096.

lead_sponsor: Diamyd Therapeutics AB

location_country:
Finland
Italy
Germany
Slovenia
United Kingdom
Sweden
Netherlands
Spain
France

location_facility: Hôpital Pellegrin Enfants, Service d'endocrinologie pédiatrique

location_facility: Azienda Ospedaliero, Universitaria di Parma, Pediatria

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Reparto di Pediatria, Ospedale S. Raffaele

location_facility: University Medical Centre Ljubljana, Department of Pediatric Endocrinology

location_facility: Hospital Materno-Infantil Vírgen del Rocío

location_facility: Barn- och ungdomskliniken, Länssjukhuset Ryhov

location_facility: Helsingin yliopistollinen keskussairaala, Lasten ja nuorten sairaala

location_facility: Hospital Materno-Infantil Clínico de Valencia

location_facility: Barn- och ungdomskliniken, Vrinnevi sjukhus

location_facility: Maternal & Child Health Sciences, University of Dundee

location_facility: CHU Montpellier Hôpital Arnaud de Villeneuve, Service de Pédiatrie 1

location_facility: Hopital Robert Debré, Service d'Endocrinologie

location_facility: Tampereen yliopistollinen sairaala, Lasten klinikka

location_facility: Haga Ziekenhuis, Lokatie Juliana Kinderziekenhuis

location_facility: Drottning Silvias Barnsjukhus, Barn- och ungdomssjukvården

location_facility: Charité Campus Virchow Childrens Hospital

location_facility: Unità Operativa di Pediatria, Policlinico

location_facility: Hôpital des Enfants, Gastroentero-nutrition-diabétologie pédiatrique

location_facility: Hôpital Necker, Clinique Robert Debré, Diabète de l'Enfant et de l'Adolescent,

location_facility: Barn- och ungdomskliniken, NU-sjukvården/NÄL

location_facility: Barn- och ungdomskliniken, Uddevalla Sjukhus

location_facility: Campus Bio-Medico, Dipartimento di Diabetologia e Endocrinologia

location_facility: Diabetologia - Dipartimento Clinica Pediatrica, Ospedale Luigi Sacco

location_facility: Hospital Materno-Infantil Vírgen del Camino

location_facility: Universitätsklinik fȕr Kinder- und Jugendmedizin, Tȕbingen

location_facility: Oulun yliopistollinen sairaala, Lasten ja nuorten klinikka

location_facility: Klinik und Poliklinik fȕr Kinder und Jugendliche der Universität Leipzig

location_facility: Barn- och ungdomskliniken, Centrallasarettet

location_facility: Seinäjoen keskussairaala, Lastentautien poliklinikka

location_facility: CHU Timone Enfants, Service de pédiatrie multidisciplinaire

location_facility: Barn- och ungdomskliniken, Universitetssjukhuset

location_facility: Clinica Pediatrica, Università di Genova

location_facility: Kuopion yliopistollinen sairaala, Lasten klinikka

location_facility: Turun yliopistollinen keskussairaala, Lastentautien Klinikka

location_facility: Diabetologia - Dipartimento Scienze Pediatriche, Ospedale Infantile, Regina Margherita

location_facility: Barn- och ungdomskliniken, Centralsjukhuset

location_facility: Barn- och ungdomscentrum, Universitetssjukhuset MAS

location_facility: Centre for Diabetes and Metabolic Medicine (DMM), Barts and The London School of Medicine and Dentistry

location_facility: Struttura Complessa di Diabetologia, Ospedale S. Michele

location_facility: Meander Medisch Centrum, Lokatie Elisabeth

location_facility: Barn och ungdomsmedicinska kliniken, Centralsjukhuset


summary:
The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir (RAL) added to a background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional antiretroviral (ARV) agents) in HIV-1 infected, ARV treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of ARV agents.

Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen (Elvitegravir group), or raltegravir plus background regimen (Raltegravir group). Due to known drug interactions, participants in the Elvitegravir group receiving RTV-boosted atazanavir (ATV) or RTV-boosted lopinavir (LPV) as part of their background regimen will receive elvitegravir at a lower dose (85 mg).

ReferenceCitation: Molina JM, Lamarca A, Andrade-Villanueva J, Clotet B, Clumeck N, Liu YP, Zhong L, Margot N, Cheng AK, Chuck SL; Study 145 Team. Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 receiving a ritonavir-boosted protease inhibitor: randomised, double-blind, phase 3, non-inferiority study. Lancet Infect Dis. 2012 Jan;12(1):27-35. doi: 10.1016/S1473-3099(11)70249-3. Epub 2011 Oct 18.

location_facility: Southwest Infectious Disease Clinical Research

location_facility: University of Manitoba - Health Sciences Centre

location_facility: Instituto de Investigacion Cientifica del Sur

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Tarrant County Infectious Disease Associates

location_facility: Brody School of Medicine at East Carolina University

location_facility: Canadian Immunodeficiency Research Collaborative (CIRC) Inc.

location_facility: AIDS Healthcare Foundation-Research Center

location_facility: Hopital Purpan - Service of Infectious Diseases

location_facility: The George Washington University Medical Center

location_facility: Ambulanzzentrum am Universitatsklinikum Hamburg Eppendorf

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

location_facility: Imperial College Healthcare NHS Trust, St. Mary's Campus

location_facility: Infectious Disease Specialists of Atlanta (IDSA)

location_facility: North Texas Infectious Disease Consultants

location_facility: Hopital Saint Antoine - Infectious Desease Department

location_facility: Universita La Sapienza Policlinico Umberto I

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: The Emory Clinic, Inc., Division of Infectious Diseases

location_facility: Treasure Coast Infectious Disease Consultants

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital General Universitario Gregorio Maranon

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

location_facility: Immunodeficiency Service, McGill University Health Centre (MUHC)

location_facility: University of Puerto Rico, School of Medicine, Proyecto ACTU

location_facility: University of North Carolina/ School of Medicine Division of Infectious Diseases/ AIDS Clinical Trials Unit

location_facility: Thomas Jefferson University Jefferson Alumni Hall

location_facility: University of Southern California, AIDS Clinical Trials Unit

location_facility: Hospital General Universitario de Alicante

location_facility: Hopital Pitie Salpetriere - Infectious Deseases Department

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Washington University School of Medicine

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Community Research Initiative of New England

location_facility: Henry Ford Hospital Div of Infectious Disease

location_facility: University Health Network, Toronto General Hospital

location_facility: Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.

location_facility: Complexo Hospitalario Xeral-Cies (Chuvi) Vigo

location_facility: University Hospital of Montpellier - Gui de Chauliac

location_facility: Hospital General Universitario del Elche

location_facility: University of Medicine and Dentistry of New Jersey; University Hospital Infectious Disease Practice

location_facility: Royal Free and University College Medical School

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Hopital de Bicentre - Service de medecine Interne et Immunologie

location_facility: Hawaii AIDS Clinical Research Program HACRP

location_facility: University of Texas Health Science Center at Houston

location_facility: University of Kentucky Healthcare/Bluegrass Care Clinic

location_facility: University of Maryland, Institute of Human Virology

title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults

location_country:
Germany
Italy
Portugal
United Kingdom
Australia
Netherlands
Mexico
Belgium
Switzerland
United States
Spain
Canada
Puerto Rico
France


title: A Multinational, Randomized, Double-blind Placebo Controlled Study of AVE8062 (25 mg/m2) Administered Every 3 Weeks in Patients With Advanced-stage Soft Tissue Sarcoma, Treated With Cisplatin (75 mg) After Failure of Anthracycline and Ifosfamide Chemotherapies.

summary:
The primary objective of the study is to compare the progression-free survival (PFS) in the 2 treatment arms

The secondary objectives of the study are :

To compare the overall survival in the 2 treatment arms
To compare the objective response rate in the 2 treatment arms
To assess the safety profile of AVE8062 (in combination with the background cisplatin therapy)
To assess the pharmacokinetics of AVE8062 and its main metabolite, RPR258063, using a population approach, in all patients enrolled in selected centers.

ReferenceCitation: Blay JY, Papai Z, Tolcher AW, Italiano A, Cupissol D, Lopez-Pousa A, Chawla SP, Bompas E, Babovic N, Penel N, Isambert N, Staddon AP, Saada-Bouzid E, Santoro A, Franke FA, Cohen P, Le-Guennec S, Demetri GD. Ombrabulin plus cisplatin versus placebo plus cisplatin in patients with advanced soft-tissue sarcomas after failure of anthracycline and ifosfamide chemotherapy: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015 May;16(5):531-40. doi: 10.1016/S1470-2045(15)70102-6. Epub 2015 Apr 8.

lead_sponsor: Sanofi

location_country:
Italy
India
Hungary
United Kingdom
Brazil
Belgium
United States
Spain
Serbia
France

location_facility:
Investigational Site Number 076006
Investigational Site Number 348001
Investigational Site Number 250007
Investigational Site Number 826001
Investigational Site Number 250002
Investigational Site Number 076007
Investigational Site Number 356003
Investigational Site Number 250004
Investigational Site Number 250008
Investigational Site Number 840004
Investigational Site Number 840002
Investigational Site Number 250010
Investigational Site Number 056004
Investigational Site Number 840001
Investigational Site Number 076004
Investigational Site Number 250006
Investigational Site Number 724004
Investigational Site Number 380003
Investigational Site Number 076008
Investigational Site Number 076009
Investigational Site Number 840007
Investigational Site Number 250001
Investigational Site Number 348002
Investigational Site Number 356004
Investigational Site Number 380001
Investigational Site Number 250005
Investigational Site Number 380004
Investigational Site Number 840003
Investigational Site Number 076002
Investigational Site Number 826002
Investigational Site Number 826003
Investigational Site Number 356005
Investigational Site Number 724001
Investigational Site Number 250009
Investigational Site Number 056005
Investigational Site Number 250012
Investigational Site Number 076005
Investigational Site Number 891002
Investigational Site Number 724003
Investigational Site Number 380002
Investigational Site Number 056001
Investigational Site Number 250003
Investigational Site Number 891001
Investigational Site Number 840005
Investigational Site Number 076003


title: A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib Plus Prednisone Versus Prednisone In Patients With Progressive Metastatic Castration-Resistant Prostate Cancer After Failure Of A Docetaxel-Based Chemotherapy Regimen

summary: This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.

ReferenceCitation: Michaelson MD, Oudard S, Ou YC, Sengelov L, Saad F, Houede N, Ostler P, Stenzl A, Daugaard G, Jones R, Laestadius F, Ullen A, Bahl A, Castellano D, Gschwend J, Maurina T, Chow Maneval E, Wang SL, Lechuga MJ, Paolini J, Chen I. Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer. J Clin Oncol. 2014 Jan 10;32(2):76-82. doi: 10.1200/JCO.2012.48.5268. Epub 2013 Dec 9.

location_country:
Finland
Germany
Poland
Australia
Brazil
Canada
France
Czech Republic
Portugal
Slovakia
Denmark
United States
Belgium
China
Peru
Italy
United Kingdom
Sweden
Korea, Republic of
Spain
Taiwan
Israel


title: 18-wk, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Comparison With Sitagliptin in Combination With Metformin in Adult Patients With T2D Who Have Inadequate Glycaemic Control on Metformin Alone

summary: Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Bristol-Myers Squibb

location_country:
Italy
Norway
Argentina
Denmark
Sweden
Mexico
Belgium
South Africa
France


acronym: Phase IIb/III NSCLC Iressa/Tarceva Failures

lead_sponsor: Boehringer Ingelheim

summary:
This randomized, double-blind, multi-center Phase IIb/III trial will be performed in patients with NSCLC who have received previous treatment with at least one but not more than two lines of cytotoxic chemotherapy (one line must have been a platinum-containing regimen) and either gefitinib or erlotinib for a period of at least 12 weeks and then progressed.

The primary objective of this randomized trial is to determine the efficacy of BIBW 2992 as a single agent (Arm A) as compared to a matching placebo (Arm B) in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment.

Patients enrolled into the trial will be treated and followed until death or lost to follow-up.

ReferenceCitation: Miller VA, Hirsh V, Cadranel J, Chen YM, Park K, Kim SW, Zhou C, Su WC, Wang M, Sun Y, Heo DS, Crino L, Tan EH, Chao TY, Shahidi M, Cong XJ, Lorence RM, Yang JC. Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial. Lancet Oncol. 2012 May;13(5):528-38. doi: 10.1016/S1470-2045(12)70087-6. Epub 2012 Mar 26. Erratum In: Lancet Oncol. 2012 May;13(5):e186.

location_facility: 1200.23.82004 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.028 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.82001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.31003 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86004 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.009 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3405 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.66002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.88601 National Taiwan University Hospital

location_facility: 1200.23.39001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.39008 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.1002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.32005 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.39007 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.82002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86009 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3304B Boehringer Ingelheim Investigational Site

location_facility: 1200.23.82005 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.88607 Tri-Service General Hospital

location_facility: 1200.23.49010 Zentralklinik Bad Berka GmbH

location_facility: 1200.23.86006 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.88606 National Cheng Kung University Hospital

location_facility: 1200.23.3302A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3304A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.013 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.029 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.039 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.024 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.85202 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.88604 Taichung Veterans General Hospital

location_facility: 1200.23.31001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.038 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3401 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.020 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.4401 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3306C Boehringer Ingelheim Investigational Site

location_facility: 1200.23.49006 HSK, Dr. Horst-Schmidt-Kliniken GmbH

location_facility: 1200.23.39003 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86008 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.65001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3305A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.32003 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.82003 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3301A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3406 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.88603 Chang Gung Memorial Hosp-Linkou

location_facility: 1200.23.86005 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.49004 Johannes Gutenberg-Universität Mainz

location_facility: 1200.23.3303A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3303C Boehringer Ingelheim Investigational Site

location_facility: 1200.23.046 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.39004 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3402 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3307A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.82006 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.050 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86003 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.32001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.027 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.32006 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.66001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.49002 Innere Klinik und Poliklinik (Tumorforschung)

location_facility: 1200.23.31002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.1009 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.49003 Asklepios Fachkliniken München-Gauting

location_facility: 1200.23.32004 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.4403 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3302B Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3306A Boehringer Ingelheim Investigational Site

location_facility: 1200.23.4406 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.88605 China Medical University Hospital

location_facility: 1200.23.1001 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3403 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.056 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.66003 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.026 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.39002 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.86007 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.4405 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.1004 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.3404 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.045 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.4404 Boehringer Ingelheim Investigational Site

location_facility: 1200.23.1005 Boehringer Ingelheim Investigational Site

title: Phase IIb/III Randomized, Double-blind Trial of BIBW 2992 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-Lung 1)

location_country:
Germany
Italy
United Kingdom
Hong Kong
Singapore
Netherlands
Belgium
United States
China
Korea, Republic of
Spain
Thailand
Taiwan
Canada
France


title: Safety and Efficacy of Insulin Detemir Combined With OAD Versus Insulin NPH Combined With OAD in Type 2 Mellitus

summary:
This trial is conducted in Europe.

The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.

ReferenceCitation: Hermansen K, Davies M, Derezinski T, Martinez Ravn G, Clauson P, Home P. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care. 2006 Jun;29(6):1269-74. doi: 10.2337/dc05-1365. Erratum In: Diabetes Care. 2007 Apr;30(4):1035.

ReferenceCitation: Davies MJ, Derezinski T, Pedersen CB, Clauson P. Reduced weight gain with insulin detemir compared to NPH insulin is not explained by a reduction in hypoglycemia. Diabetes Technol Ther. 2008 Aug;10(4):273-7. doi: 10.1089/dia.2008.0282.

ReferenceCitation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.

lead_sponsor: Novo Nordisk A/S

location_country: Macedonia, The Former Yugoslav Republic of


title: A Twenty-Eight Week, Open-Label, Safety Study of Flibanserin 50 Mgs to 100 Mgs Daily in Premenopausal European Women With HSDD

summary: Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens

lead_sponsor: Sprout Pharmaceuticals, Inc

location_country:
Finland
Germany
Italy
Hungary
United Kingdom
Sweden
Netherlands
Austria
Belgium
Spain
Czech Republic
France

location_facility: 511.118.35804 Boehringer Ingelheim Investigational Site

location_facility: 511.118.46001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.49006 Boehringer Ingelheim Investigational Site

location_facility: 511.118.39004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.43006 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3314A Boehringer Ingelheim Investigational Site

location_facility: 511.118.31001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3301A Boehringer Ingelheim Investigational Site

location_facility: 511.118.46003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44008 Boehringer Ingelheim Investigational Site

location_facility: 511.118.42002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.31005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.32003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.46004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3310A Boehringer Ingelheim Investigational Site

location_facility: 511.118.49004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.31007 Boehringer Ingelheim Investigational Site

location_facility: 511.118.49001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.36005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.39003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.31006 Boehringer Ingelheim Investigational Site

location_facility: 511.118.42004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.43004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.32002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.34004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44009 Boehringer Ingelheim Investigational Site

location_facility: 511.118.34003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3311A Boehringer Ingelheim Investigational Site

location_facility: 511.118.32004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.42001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3305A Boehringer Ingelheim Investigational Site

location_facility: 511.118.3303A Boehringer Ingelheim Investigational Site

location_facility: 511.118.49002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.36004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.46005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3306A Boehringer Ingelheim Investigational Site

location_facility: 511.118.44010 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44007 Boehringer Ingelheim Investigational Site

location_facility: 511.118.35802 Boehringer Ingelheim Investigational Site

location_facility: 511.118.49005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.35805 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.43005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.31004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.36003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.32005 Boehringer Ingelheim Investigational Site

location_facility: 511.118.39001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.46009 Boehringer Ingelheim Investigational Site

location_facility: 511.118.44004 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3308A Boehringer Ingelheim Investigational Site

location_facility: 511.118.44003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.46006 Boehringer Ingelheim Investigational Site

location_facility: 511.118.34002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.49008 Boehringer Ingelheim Investigational Site

location_facility: 511.118.43002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.31002 Boehringer Ingelheim Investigational Site

location_facility: 511.118.32006 Boehringer Ingelheim Investigational Site

location_facility: 511.118.42003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.34001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.36001 Boehringer Ingelheim Investigational Site

location_facility: 511.118.3312A Boehringer Ingelheim Investigational Site

location_facility: 511.118.35801 Boehringer Ingelheim Investigational Site

location_facility: 511.118.31003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.49003 Boehringer Ingelheim Investigational Site

location_facility: 511.118.35803 Boehringer Ingelheim Investigational Site


acronym: MTX-IR Study

summary: The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.

ReferenceCitation: Alten R, Bingham CO 3rd, Cohen SB, Curtis JR, Kelly S, Wong D, Genovese MC. Antibody response to pneumococcal and influenza vaccination in patients with rheumatoid arthritis receiving abatacept. BMC Musculoskelet Disord. 2016 May 26;17:231. doi: 10.1186/s12891-016-1082-z.

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repositories_concat: PubMed Central;refubium.fu-berlin.de

ReferenceCitation: Genovese MC, Tena CP, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, Nash P, Simon-Campos JA, Box J, Legerton CW 3rd, Nasonov E, Durez P, Delaet I, Teng J, Alten R. Subcutaneous abatacept for the treatment of rheumatoid arthritis: longterm data from the ACQUIRE trial. J Rheumatol. 2014 Apr;41(4):629-39. doi: 10.3899/jrheum.130112. Epub 2014 Mar 1.

publisher_dissemination: The Journal of Rheumatology

ReferenceCitation: Genovese MC, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, Nash P, Simon-Campos JA, Porawska W, Box J, Legerton C 3rd, Nasonov E, Durez P, Aranda R, Pappu R, Delaet I, Teng J, Alten R. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate. Arthritis Rheum. 2011 Oct;63(10):2854-64. doi: 10.1002/art.30463.

location_facility: Cincinnati Rheumatic Disease Study Group

location_facility: Arthritis Assoc And Osteo Ctr Of Col Sprgs

location_facility: Oklahoma Center For Arthritis Therapy And Research

location_facility: Arthritis Clinic Of Northern Virginia, P.C.

location_facility: The Arthritis Clinic & Carolina Bone & Joint

location_facility: Center For Arthritis & Rheumatic Diseases, Pc

location_facility: Boise Rheumatology/ Intermountain Research Center, Inc

location_facility: South Puget Sound Clinincal Research Center

location_facility: Asheville Rheumatology & Osteoporosis Research Asso P. A.

location_facility: Rheumatic Disease Clinical Research Center, Llc

location_facility: Arthritis And Rheumatic Disease Specialties

location_facility: Rheumatology Associates Of Central Florida

location_facility: Arthritis & Osteoporosis Treatment Center, Pa

location_facility: Albuquerque Rehabilitation & Rheumatology Pc

location_facility: Valerius Medical Group &Research Ctr. Of Greater Long Beach

location_facility: Allergy & Rheumatology Medical Clinic, Inc.

title: A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Turkey
Chile
Canada
France
Hungary
United States
India
Belgium
Peru
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Greece
South Africa
Taiwan
Russian Federation


title: An Open-label, Randomized Study to Evaluate the Effect of Tarceva, Compared With Alimta (Pemetrexed) or Taxotere (Docetaxel),on Survival in Patients With Advanced, Recurrent or Metastatic Non-small Cell Lung Cancer Who Have Experienced Disease Progression During Platinum-based Chemotherapy

summary: This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.

ReferenceCitation: Ciuleanu T, Stelmakh L, Cicenas S, Miliauskas S, Grigorescu AC, Hillenbach C, Johannsdottir HK, Klughammer B, Gonzalez EE. Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN): a randomised multicentre, open-label, phase 3 study. Lancet Oncol. 2012 Mar;13(3):300-8. doi: 10.1016/S1470-2045(11)70385-0. Epub 2012 Jan 24.

location_country:
Germany
Poland
New Zealand
Australia
Chile
Canada
France
Czech Republic
Lithuania
Slovenia
Slovakia
Hungary
Denmark
Ukraine
Romania
Belgium
China
Malaysia
Italy
United Kingdom
Venezuela
Austria
Korea, Republic of
Spain
Greece
South Africa
Russian Federation


acronym: POS Phase 3

lead_sponsor: UCB Pharma SA

summary: This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.

ReferenceCitation: Ryvlin P, Werhahn KJ, Blaszczyk B, Johnson ME, Lu S. Adjunctive brivaracetam in adults with uncontrolled focal epilepsy: results from a double-blind, randomized, placebo-controlled trial. Epilepsia. 2014 Jan;55(1):47-56. doi: 10.1111/epi.12432. Epub 2013 Oct 28.

ReferenceCitation: Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016 Jul;57(7):1139-51. doi: 10.1111/epi.13416. Epub 2016 Jun 6.

ReferenceCitation: Ben-Menachem E, Mameniskiene R, Quarato PP, Klein P, Gamage J, Schiemann J, Johnson ME, Whitesides J, McDonough B, Eckhardt K. Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies. Neurology. 2016 Jul 19;87(3):314-23. doi: 10.1212/WNL.0000000000002864. Epub 2016 Jun 22.

ReferenceCitation: Brodie MJ, Whitesides J, Schiemann J, D'Souza J, Johnson ME. Tolerability, safety, and efficacy of adjunctive brivaracetam for focal seizures in older patients: A pooled analysis from three phase III studies. Epilepsy Res. 2016 Nov;127:114-118. doi: 10.1016/j.eplepsyres.2016.08.018. Epub 2016 Aug 18.

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Mukuria C, Young T, Keetharuth A, Borghs S, Brazier J. Sensitivity and responsiveness of the EQ-5D-3L in patients with uncontrolled focal seizures: an analysis of Phase III trials of adjunctive brivaracetam. Qual Life Res. 2017 Mar;26(3):749-759. doi: 10.1007/s11136-016-1483-3. Epub 2016 Dec 21.

ReferenceCitation: Moseley BD, Sperling MR, Asadi-Pooya AA, Diaz A, Elmouft S, Schiemann J, Whitesides J. Efficacy, safety, and tolerability of adjunctive brivaracetam for secondarily generalized tonic-clonic seizures: Pooled results from three Phase III studies. Epilepsy Res. 2016 Nov;127:179-185. doi: 10.1016/j.eplepsyres.2016.09.003. Epub 2016 Sep 3.

ReferenceCitation: Brandt C, Borghs S, Elmoufti S, Mueller K, Townsend R, de la Loge C. Health-related quality of life in double-blind Phase III studies of brivaracetam as adjunctive therapy of focal seizures: A pooled, post-hoc analysis. Epilepsy Behav. 2017 Apr;69:80-85. doi: 10.1016/j.yebeh.2016.11.031. Epub 2017 Feb 23.

ReferenceCitation: Klein P, Johnson ME, Schiemann J, Whitesides J. Time to onset of sustained >/=50% responder status in patients with focal (partial-onset) seizures in three phase III studies of adjunctive brivaracetam treatment. Epilepsia. 2017 Feb;58(2):e21-e25. doi: 10.1111/epi.13631. Epub 2016 Dec 18.

ReferenceCitation: Asadi-Pooya AA, Sperling MR, Chung S, Klein P, Diaz A, Elmoufti S, Schiemann J, Whitesides J. Efficacy and tolerability of adjunctive brivaracetam in patients with prior antiepileptic drug exposure: A post-hoc study. Epilepsy Res. 2017 Mar;131:70-75. doi: 10.1016/j.eplepsyres.2017.02.007. Epub 2017 Feb 27. Erratum In: Epilepsy Res. 2017 Nov;137:165-166.

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

repository_institution: Thomas Jefferson University - Jefferson Digital Commons

ReferenceCitation: Benbadis S, Klein P, Schiemann J, Diaz A, Elmoufti S, Whitesides J. Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy Behav. 2018 Mar;80:129-134. doi: 10.1016/j.yebeh.2017.12.024. Epub 2018 Feb 3.

ReferenceCitation: Brodie MJ, Fakhoury T, McDonough B, Colson AO, Stockis A, Elmoufti S, Whitesides J. Brivaracetam-induced elevation of carbamazepine epoxide levels: A post-hoc analysis from the clinical development program. Epilepsy Res. 2018 Sep;145:55-62. doi: 10.1016/j.eplepsyres.2018.06.002. Epub 2018 Jun 4.

ReferenceCitation: Klein P, Laloyaux C, Elmoufti S, Gasalla T, Martin MS. Time course of 75%-100% efficacy response of adjunctive brivaracetam. Acta Neurol Scand. 2020 Aug;142(2):175-180. doi: 10.1111/ane.13287. Epub 2020 Jun 9.

ReferenceCitation: Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.

ReferenceCitation: Ryvlin P, Dimova S, Elmoufti S, Floricel F, Laloyaux C, Nondonfaz X, Biton V. Tolerability and efficacy of adjunctive brivaracetam in adults with focal seizures by concomitant antiseizure medication use: Pooled results from three phase 3 trials. Epilepsia. 2022 Aug;63(8):2024-2036. doi: 10.1111/epi.17304. Epub 2022 Jun 10.

ReferenceCitation: Bresnahan R, Panebianco M, Marson AG. Brivaracetam add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2022 Mar 14;3(3):CD011501. doi: 10.1002/14651858.CD011501.pub3.

ReferenceCitation: Lee SK, Heo K, Kim SE, Lee SA, Elmoufti S, Laloyaux C, Hur B. Effect of Number of Previous Antiseizure Medications on Efficacy and Tolerability of Adjunctive Brivaracetam for Uncontrolled Focal Seizures: Post Hoc Analysis. Adv Ther. 2021 Jul;38(7):4082-4099. doi: 10.1007/s12325-021-01816-5. Epub 2021 Jun 21.

ReferenceCitation: Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

title: A Multi-center, Double-blind, Parallel-group, Placebo Controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures.

location_country:
Finland
Germany
Italy
Poland
India
Hungary
United Kingdom
Netherlands
Switzerland
Belgium
Spain
France


title: A 31-Week, Efficacy, Safety and Tolerability Study of Eszopiclone 3 mg Co-administered With Venlafaxine in Subjects With Major Depressive Disorder (MDD) and Co-existing Insomnia

summary: To evaluate the antidepressant effect of adjunctive treatment with Eszopiclone in subjects receiving venlafaxine for the treatment of Major Depressive Disorder (MDD).

lead_sponsor: Sumitomo Pharma America, Inc.

location_country:
Poland
Hungary
United Kingdom
Romania
Austria
Croatia
Ukraine
Serbia
Russian Federation
France


title: A Multinational, Prospective, Randomized, Double-blind Study to Investigate the Efficacy and Safety of Sequential Intravenous/Oral Moxifloxacin in Comparison to Intravenous Levofloxacin Plus Intravenous Ceftriaxone Followed by Oral Levofloxacin, in the Treatment of Patients With Severe Community-acquired Pneumonia

summary: Sequential therapy with intravenous to oral moxifloxacin, was tested at 69 study centres in 17 countries to determine if this treatment regimen is safe and effective in treating hospitalized adult patients with community-acquired pneumonia. 748 patients were participated in the study over an 18 months period. Individual patient involvement in the study was approximately 4-6 weeks. Moxifloxacin was compared to a combination treatment regimen of high dose intravenous ceftriaxone plus high dose intravenous levofloxacin followed by high dose oral levofloxacin.

ReferenceCitation: Torres A, Garau J, Arvis P, Carlet J, Choudhri S, Kureishi A, Le Berre MA, Lode H, Winter J, Read RC; MOTIV (MOxifloxacin Treatment IV) Study Group. Moxifloxacin monotherapy is effective in hospitalized patients with community-acquired pneumonia: the MOTIV study--a randomized clinical trial. Clin Infect Dis. 2008 May 15;46(10):1499-509. doi: 10.1086/587519.

location_country:
Germany
Lithuania
Poland
Colombia
Portugal
Israel
Argentina
United Kingdom
Sweden
Netherlands
Mexico
Belgium
Spain
Greece
South Africa
Chile
Peru
France


title: A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination With Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia

acronym: LUCID

summary: This is a randomized (1:1), open-label, multicenter, active-controlled study in patients with previously treated CD23+ and CD20+ relapsed CLL. Patients will receive treatment with either lumiliximab in combination with FCR or FCR alone.

ReferenceType: background

ReferenceCitation: Byrd JC, Kipps TJ, Flinn IW, Castro J, Lin TS, Wierda W, Heerema N, Woodworth J, Hughes S, Tangri S, Harris S, Wynne D, Molina A, Leigh B, O'Brien S. Phase 1/2 study of lumiliximab combined with fludarabine, cyclophosphamide, and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia. Blood. 2010 Jan 21;115(3):489-95. doi: 10.1182/blood-2009-08-237727. Epub 2009 Oct 20.

ReferenceCitation: Pathan NI, Chu P, Hariharan K, Cheney C, Molina A, Byrd J. Mediation of apoptosis by and antitumor activity of lumiliximab in chronic lymphocytic leukemia cells and CD23+ lymphoma cell lines. Blood. 2008 Feb 1;111(3):1594-602. doi: 10.1182/blood-2007-03-082024. Epub 2007 Nov 21.

ReferenceCitation: Byrd JC, O'Brien S, Flinn IW, Kipps TJ, Weiss M, Rai K, Lin TS, Woodworth J, Wynne D, Reid J, Molina A, Leigh B, Harris S. Phase 1 study of lumiliximab with detailed pharmacokinetic and pharmacodynamic measurements in patients with relapsed or refractory chronic lymphocytic leukemia. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4448-55. doi: 10.1158/1078-0432.CCR-06-1463.

ReferenceCitation: Awan FT, Hillmen P, Hellmann A, Robak T, Hughes SG, Trone D, Shannon M, Flinn IW, Byrd JC; LUCID trial investigators. A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia. Br J Haematol. 2014 Nov;167(4):466-77. doi: 10.1111/bjh.13061. Epub 2014 Aug 8.

evidence: open (via free article)

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

lead_sponsor: Biogen

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Canada
France
Czech Republic
Lithuania
Portugal
Slovakia
United States
India
Romania
Belgium
Italy
United Kingdom
Austria
Spain
Greece
Russian Federation
Israel


acronym: S-TRAC

summary: To compare the disease free survival time and safety of sunitinib with placebo in adjuvant treatment patients at high risk of recurrent kidney cancer after surgery.

ReferenceCitation: Patel A, Ravaud A, Motzer RJ, Pantuck AJ, Staehler M, Escudier B, Martini JF, Lechuga M, Lin X, George DJ. Exploratory analysis of the platelet-to-lymphocyte ratio prognostic value in the adjuvant renal cell cancer setting. Future Oncol. 2021 Feb;17(4):403-409. doi: 10.2217/fon-2020-0652. Epub 2020 Oct 8.

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

repositories_institution: California Digital Library - eScholarship

publisher_dissemination: Future Science Ltd

ReferenceCitation: Ouzaid I, Kammerer-Jacquet SF, Khene Z, Ravaud A, Patard JJ, Bensalah K, Rioux-Leclercq N. Exploring Biological Predictive Factors of Progression After Surgery in High-Risk Renal Cell Carcinoma: Results From the French Cohort of the Randomized S-TRAC Trial Patients. Front Surg. 2020 Jun 5;7:26. doi: 10.3389/fsurg.2020.00026. eCollection 2020.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

publisher_dissemination: Frontiers

ReferenceCitation: Staehler M, Motzer RJ, George DJ, Pandha HS, Donskov F, Escudier B, Pantuck AJ, Patel A, DeAnnuntis L, Bhattacharyya H, Ramaswamy K, Zanotti G, Lin X, Lechuga M, Serfass L, Paty J, Ravaud A. Adjuvant sunitinib in patients with high-risk renal cell carcinoma: safety, therapy management, and patient-reported outcomes in the S-TRAC trial. Ann Oncol. 2018 Oct 1;29(10):2098-2104. doi: 10.1093/annonc/mdy329.

repository_institution: Elsevier - Scopus

repository_institution: University of California - eScholarship University of California

repositories:
PubMed Central
Pure (Denmark)
escholarship.org

ReferenceCitation: Rini BI, Escudier B, Martini JF, Magheli A, Svedman C, Lopatin M, Knezevic D, Goddard AD, Febbo PG, Li R, Lin X, Valota O, Staehler M, Motzer RJ, Ravaud A. Validation of the 16-Gene Recurrence Score in Patients with Locoregional, High-Risk Renal Cell Carcinoma from a Phase III Trial of Adjuvant Sunitinib. Clin Cancer Res. 2018 Sep 15;24(18):4407-4415. doi: 10.1158/1078-0432.CCR-18-0323. Epub 2018 May 17.

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: George DJ, Martini JF, Staehler M, Motzer RJ, Magheli A, Escudier B, Gerletti P, Li S, Casey M, Laguerre B, Pandha HS, Pantuck AJ, Patel A, Lechuga MJ, Ravaud A. Immune Biomarkers Predictive for Disease-Free Survival with Adjuvant Sunitinib in High-Risk Locoregional Renal Cell Carcinoma: From Randomized Phase III S-TRAC Study. Clin Cancer Res. 2018 Apr 1;24(7):1554-1561. doi: 10.1158/1078-0432.CCR-17-2822. Epub 2018 Jan 26.

repository_institution: University of Surrey - Surrey Open Research repository

ReferenceCitation: Motzer RJ, Ravaud A, Patard JJ, Pandha HS, George DJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Casey M, Serfass L, Pantuck AJ, Staehler M. Adjuvant Sunitinib for High-risk Renal Cell Carcinoma After Nephrectomy: Subgroup Analyses and Updated Overall Survival Results. Eur Urol. 2018 Jan;73(1):62-68. doi: 10.1016/j.eururo.2017.09.008. Epub 2017 Sep 28.

evidence: open (via crossref license, author manuscript)

ReferenceCitation: Ravaud A, Motzer RJ, Pandha HS, George DJ, Pantuck AJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Martini JF, Ramaswamy K, Casey M, Staehler M, Patard JJ; S-TRAC Investigators. Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy. N Engl J Med. 2016 Dec 8;375(23):2246-2254. doi: 10.1056/NEJMoa1611406. Epub 2016 Oct 9.

location_facility: Department of Urology, Shanghai Changhai Hospital

location_facility: Institut de Cancerologie de l'Ouest - Centre Rene Gauducheau

location_facility: Klinik und Poliklinik fuer Urologie, UKSH Campus Luebeck

location_facility: Hematology and Oncology Specialists, LLC

location_facility: P.O.SS. ANNUNZIATA 14° LIVELLO CORPO A, Clinica Oncologica

location_facility: Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2

location_facility: Universitaetsklinikum Ulm, Urologische Universitaetsklinik

location_facility: Medical Oncology, Patterson institute for Cancer Research

location_facility: Universitaetsklinikum Bonn, Klinik und Poliklinik fuer Urologie

location_facility: Department of Urology,Peking University First Hospital

location_facility: "Alexandra" general hospital of Athens, department of Clinical Therapeutics, Oncology Unit

location_facility: The University of North Carolina at Chapel Hill

location_facility: Onkologisches Institut, Inselspital Bern

location_facility: Instituto Nacional de Cancerologia - ESE

location_facility: Department of Internal Medicine, Seoul National University Bundang Hospital

location_facility: Norrlands universitetssjukhus, Urologiska kliniken

location_facility: Klinikum der Friedrich-Schiller-Universitaet Jena, Universitaetsklinik und Poliklinik fuer Urologie

location_facility: Chinese PLA General Hospital/Urology Department

location_facility: The first affiliated hospital of Soochow university/Department of Urology

location_facility: Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej Akademii Medycznej UM-Centralny Szpital Weteranow

location_facility: Klinika Onkologii, Wojskowy Instytut Medyczny

location_facility: Klinikum Nuernberg, 5. Medizinische Klinik, Haematologie / Onkologie

location_facility: Oddzial Chemioterapii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego

location_facility: Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine

location_facility: Klinika Urologii i Onkologii Urologicznej Akademicki Szpital Kliniczny

location_facility: Universitaetsklinikum Muenster Klinik und Poliklinik fuer Urologie

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 2 im. Wojskowej A

location_facility: Azienda Socio-Sanitaria Territoriale di Cremona, Ospedale di Cremona

location_facility: Fakultni nemocnice v Motole, Klinika zobrazovacich metod

location_facility: Institut Gustave Roussy / Service d'Immunotherapie

location_facility: Ronald Reagan UCLA Medical Center Department of Pharmaceutical Services

location_facility: Urology Department, Sun Yet-Sen University Cancer Center

location_facility: IRCCS AO Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro

location_facility: Ludwigs-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik

location_facility: Unita' Operativa di Oncologia Medica, Policlinico Sant'Orsola Malpighi

location_facility: Post Graduate Medical School, University of Surrey

location_facility: Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II

location_facility: The Second Hospital of Tianjin Medical University

location_facility: Urology Department, South-Western Hospital, 3rd Military Medical University.

location_facility: Fudan University Cancer Hospital, Department of Urology

location_facility: Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

location_facility: Fakultni nemocnice v Motole, Radioterapeuticko-onkologicke oddeleni

location_facility: Institut Claudius Regaud - Centre de Lutte Contre le Cancer

location_facility: St. Mary's Hospital, Imperial College, Health care NHS Trust

location_facility: Divisione di Oncologia, AORN Antonio Cardarelli

location_facility: Fakultni nemocnice v Motole, Ustav nuklearni mediciny

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

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Tianjin Oncology Hospital, urology department

location_facility: Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Eberhardt-Karls-Universität Tübingen, Klinik für Urologie

location_facility: Department of Urology, the Second Affiliated Hospital of Zhejiang University College of Medicine

location_facility: Complexo Hospitalario Universitario A Coruna. Hospital Teresa Herrera

location_facility: Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie

location_facility: Universitaetsklinikum Hamburg-Eppendorf, Klinik fuer Urologie

location_facility: Charite Universitaetsmedizin Berlin, Campus Charite Mitte

title: Sunitinib Treatment Of Renal Adjuvant Cancer (S-trac): A Randomized Double-blind Phase 3 Study Of Adjuvant Sunitinib Vs. Placebo In Subjects At High Risk Of Recurrent Rcc

location_country:
Germany
Ireland
Poland
Australia
Czechia
France
Colombia
Slovakia
Denmark
Switzerland
United States
China
Malaysia
Italy
United Kingdom
Sweden
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Israel


summary:
This trial is conducted in Europe.

The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

title: Efficacy and Safety of Inhaled Pre-prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes

location_country:
Finland
Ireland
Germany
United Kingdom
Netherlands
Austria
Switzerland
Spain
France


title: A Randomized, Open-label Study of the Effect of NeoRecormon on Reduction of Cardiovascular Risk in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy.

summary: This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.

ReferenceCitation: Locatelli F, Eckardt KU, Macdougall IC, Tsakiris D, Clyne N, Burger HU, Scherhag A, Drueke TB; Cardiovascular Risk Reduction in Early Anaemia Trial with Epoetin Beta investigators and coordinators. Value of N-terminal brain natriuretic peptide as a prognostic marker in patients with CKD: results from the CREATE study. Curr Med Res Opin. 2010 Nov;26(11):2543-52. doi: 10.1185/03007995.2010.516237. Epub 2010 Sep 17.

ReferenceCitation: Drueke TB, Locatelli F, Clyne N, Eckardt KU, Macdougall IC, Tsakiris D, Burger HU, Scherhag A; CREATE Investigators. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med. 2006 Nov 16;355(20):2071-84. doi: 10.1056/NEJMoa062276.

location_country:
Finland
Germany
Ireland
Poland
Thailand
Turkey
France
Czech Republic
Portugal
Hong Kong
Denmark
Belgium
Italy
Norway
United Kingdom
Austria
Mexico
Spain
Greece
Taiwan
Russian Federation
Sweden


title: A Phase 3, Randomized, Open-label, Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With NRTIs in Antiretroviral Naive HIV-1 Infected Subjects

summary: The purpose of this study was to compare the safety and tolerability of the to-be-marketed lopinavir/ritonavir (LPV/r) tablet formulation with the marketed soft gel capsule (SGC) formulation and to compare the safety, tolerability, and antiviral activity of once daily (QD) and twice daily (BID) dosing of the LPV/r tablet formulation in combination with select nucleoside reverse transcriptase inhibitors (NRTIs) in patients who have not previously received antiretroviral treatment.

lead_sponsor: Abbott

location_country:
Germany
Ireland
Poland
Australia
Canada
France
Czech Republic
Switzerland
United States
Belgium
Puerto Rico
Italy
United Kingdom
Singapore
Netherlands
Spain
Greece
Taiwan
Russian Federation

location_facility:
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title: Evaluate the Safety and Immunogenicity of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to a 0,1,6 Month Schedule in Healthy Female Subjects (10 - 14 Years)

summary: Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the safety and immunogenicity of GSK Biologicals HPV-16/18 vaccine over 12 months, in pre-teen and adolescent women of 10-14 years of age at study start. Approximately 2000 study subjects will receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.

ReferenceCitation: Boxus M, Lockman L, Fochesato M, Lorin C, Thomas F, Giannini SL. Antibody avidity measurements in recipients of Cervarix vaccine following a two-dose schedule or a three-dose schedule. Vaccine. 2014 May 30;32(26):3232-6. doi: 10.1016/j.vaccine.2014.04.005. Epub 2014 Apr 13.

ReferenceCitation: Schwarz TF, Huang LM, Medina DM, Valencia A, Lin TY, Behre U, Catteau G, Thomas F, Descamps D. Four-year follow-up of the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine when administered to adolescent girls aged 10-14 years. J Adolesc Health. 2012 Feb;50(2):187-94. doi: 10.1016/j.jadohealth.2011.11.004.

ReferenceCitation: Medina DM, Valencia A, de Velasquez A, Huang LM, Prymula R, Garcia-Sicilia J, Rombo L, David MP, Descamps D, Hardt K, Dubin G; HPV-013 Study Group. Safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine: a randomized, controlled trial in adolescent girls. J Adolesc Health. 2010 May;46(5):414-21. doi: 10.1016/j.jadohealth.2010.02.006.

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:
Germany
Colombia
Norway
Australia
Sweden
Korea, Republic of
Honduras
Spain
Panama
Taiwan
Czech Republic
France

intervention_type: Biological


title: Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30, Biphasic Insulin Aspart 50/50, and Biphasic Insulin Aspart 30/70 All in Combination With Metformin in Subjects With Type 2 Diabetes (the INTENSIMIX Trial).

summary: This trial is conducted in Europe. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different premixed insulin analogues given in combination with an oral anti-diabetic drug.

ReferenceCitation: Garber AJ, Ligthelm R, Christiansen JS, Liebl A. Premixed insulin treatment for type 2 diabetes: analogue or human? Diabetes Obes Metab. 2007 Sep;9(5):630-9. doi: 10.1111/j.1463-1326.2006.00654.x.

ReferenceCitation: Cucinotta D, Smirnova O, Christiansen JS, Kanc K, le Devehat C, Wojciechowska M, Lopez de la Torre M, Liebl A. Three different premixed combinations of biphasic insulin aspart - comparison of the efficacy and safety in a randomized controlled clinical trial in subjects with type 2 diabetes. Diabetes Obes Metab. 2009 Jul;11(7):700-8. doi: 10.1111/j.1463-1326.2009.01035.x. Epub 2009 May 19.

location_country:
France
Germany
Italy
Poland
Slovenia
Hungary
United Kingdom
Denmark
Romania
Netherlands
Austria
Belgium
Switzerland
Spain
Turkey
Bulgaria
Russian Federation
Czech Republic