acronym: ENGAGE

summary: The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Böckler D, Fitridge R, Wolf Y, Hayes P, Silveira PG, Numan F, Riambau V; ENGAGE Investigators. Rationale and design of the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE): interim analysis at 30 days of the first 180 patients enrolled. J Cardiovasc Surg (Torino). 2010 Aug;51(4):481-91.

ReferenceCitation: Stokmans RA, Teijink JA, Forbes TL, Böckler D, Peeters PJ, Riambau V, Hayes PD, van Sambeek MR. Early results from the ENGAGE registry: real-world performance of the Endurant Stent Graft for endovascular AAA repair in 1262 patients. Eur J Vasc Endovasc Surg. 2012 Oct;44(4):369-75. doi: 10.1016/j.ejvs.2012.07.005. Epub 2012 Jul 24.

family: Stokmans

full_name: R.A. Stokmans

family: Teijink

full_name: J.A.W. Teijink

family: Forbes

full_name: T.L. Forbes

family: Böckler

full_name: D. Böckler

given: D.

family: Peeters

full_name: P.J. Peeters

family: Riambau

full_name: V. Riambau

given: V.

family: Hayes

full_name: P.D. Hayes

family: van Sambeek

full_name: M.R.H.M. van Sambeek

journal_name: European Journal of Vascular and Endovascular Surgery

evidence: open (via crossref license)

title: Early Results from the ENGAGE Registry: Real-world Performance of the Endurant Stent Graft for Endovascular AAA Repair in 1262 Patients

ReferenceCitation: Stokmans RA, Teijink JA, Cuypers PW, Riambau V, van Sambeek MR. No differences in perioperative outcome between symptomatic and asymptomatic AAAs after EVAR: an analysis from the ENGAGE Registry. Eur J Vasc Endovasc Surg. 2012 Jun;43(6):667-73. doi: 10.1016/j.ejvs.2012.02.034. Epub 2012 Mar 21.

family: Cuypers

full_name: P.W.M. Cuypers

title: No Differences in Perioperative Outcome between Symptomatic and Asymptomatic AAAs after EVAR: An Analysis from the ENGAGE Registry

ReferenceCitation: Dubois L, Novick TV, Harris JR, Derose G, Forbes TL. Outcomes after endovascular abdominal aortic aneurysm repair are equivalent between genders despite anatomic differences in women. J Vasc Surg. 2013 Feb;57(2):382-389.e1. doi: 10.1016/j.jvs.2012.09.075. Epub 2012 Dec 21.

family: Dubois

full_name: Luc Dubois

given: Luc

family: Novick

full_name: Teresa V. Novick

given: Teresa V.

family: Harris

full_name: Jeremy R. Harris

given: Jeremy R.

family: DeRose

full_name: Guy DeRose

given: Guy

full_name: Thomas L. Forbes

given: Thomas L.

ReferenceCitation: Pol RA, Zeebregts CJ, van Sterkenburg SM, Reijnen MM; ENGAGE Investigators. Thirty-day outcome and quality of life after endovascular abdominal aortic aneurysm repair in octogenarians based on the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE). J Vasc Surg. 2012 Jul;56(1):27-35. doi: 10.1016/j.jvs.2011.12.080. Epub 2012 Mar 28.

ReferenceCitation: Tang T, Sadat U, Walsh S, Hayes PD; ENGAGE Investigators. Comparison of the endurant bifurcated endograft vs. aortouni-iliac stent-grafting in patients with abdominal aortic aneurysms: experience from the ENGAGE registry. J Endovasc Ther. 2013 Apr;20(2):172-81. doi: 10.1583/1545-1550-20.2.172.

publisher: International Society of Endovascular Specialists

title: Comparison of the Endurant Bifurcated Endograft vs. Aortouni-iliac Stent-Grafting in Patients With Abdominal Aortic Aneurysms: Experience From the ENGAGE Registry

ReferenceCitation: Pol RA, Zeebregts CJ, van Sterkenburg SM, Ferreira LM, Goktay Y, Reijnen MM; Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) Investigators. Outcome and quality of life after endovascular abdominal aortic aneurysm repair in octogenarians. J Vasc Surg. 2014 Aug;60(2):308-17. doi: 10.1016/j.jvs.2014.02.009. Epub 2014 Mar 20.

ReferenceCitation: Kiguchi MM, Forbes TL, Teijink JA, Pliagas GA, Ellozy SH, Böckler D, Makaroun MS. Clinical application and early outcomes of the aortouni-iliac configuration for endovascular aneurysm repair. J Vasc Surg. 2014 Dec;60(6):1452-9. doi: 10.1016/j.jvs.2014.08.063. Epub 2014 Oct 3. Erratum in: J Vasc Surg. 2015 Jan;61(1):285. Boeckler, Dittmar [Corrected to Böckler, Dittmar].

ReferenceCitation: Faure EM, Becquemin JP, Cochennec F; ENGAGE collaborators. Predictive factors for limb occlusions after endovascular aneurysm repair. J Vasc Surg. 2015 May;61(5):1138-45.e2. doi: 10.1016/j.jvs.2014.11.084. Epub 2015 Feb 2. Review.

ReferenceCitation: Dijkstra ML, Zeebregts CJ, Verhagen HJM, Teijink JAW, Power AH, Bockler D, Peeters P, Riambau V, Becquemin JP, Reijnen MMPJ; ENGAGE investigators. Incidence, natural course, and outcome of type II endoleaks in infrarenal endovascular aneurysm repair based on the ENGAGE registry data. J Vasc Surg. 2020 Mar;71(3):780-789. doi: 10.1016/j.jvs.2019.04.486. Epub 2019 Aug 20.

ReferenceCitation: Dijkstra ML, van Sterkenburg SM, Lardenoye JW, Zeebregts CJ, Reijnen MM; ENGAGE Investigators. One-Year Outcomes of Endovascular Aneurysm Repair in High-Risk Patients Using the Endurant Stent-Graft: Comparison of the ASA Classification and SVS/AAVS Medical Comorbidity Grading System for the Prediction of Mortality and Adverse Events. J Endovasc Ther. 2016 Aug;23(4):574-82. doi: 10.1177/1526602816648455. Epub 2016 May 10.

name: Department of Surgery, Rijnstate Hospital, Arnhem, the Netherlands

name: Department of Surgery, Division of Vascular Surgery, University Medical Center Groningen, University of Groningen, the Netherlands

ReferenceCitation: Broos PP, Stokmans RA, van Sterkenburg SM, Torsello G, Vermassen F, Cuypers PW, van Sambeek MR, Teijink JA. Performance of the Endurant stent graft in challenging anatomy. J Vasc Surg. 2015 Aug;62(2):312-8. doi: 10.1016/j.jvs.2015.03.024. Epub 2015 May 1.

ipd_sharing_description: Only multi center data will be available

location_country:
Greece
Australia
Belgium
Uruguay
France
Poland
Lithuania
Slovakia
Thailand
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Portugal
China
Germany
United Kingdom
Italy
Austria
Czechia
Israel
New Zealand
Spain
Turkey

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE

location_facility: Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

location_facility: The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital

location_facility: Yonsei University health System -Severence Hospital

location_facility: Life Healthcare - Life St Georges Hospital

location_facility: Life Healthcare - Life Kingsbury Hospital

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

location_facility: St George's University Hospitals - NHS Trust

location_facility: JMLS Medical Services PTY, trading as Perth Institute of Vascular Research

location_facility: CHU de Bordeaux - Centre Universitaire Pellegrin

location_facility: Hôpitaux Universitaires - Hôpital Henri Mondor

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Hospital Universitari Clínic de Barcelona

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

location_facility: IKEM - Institutu Klinicke a Experimentalni Mediciny

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: West China Hospital of Sichuan University

location_facility: Helse Bergen HF - Haukeland Universitetssjukehus

location_facility: Hospital Universitario Central de Asturias

location_facility: Complejo Hospitalario Universitario Granada Hospital Campus de la Salud

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Euromedica - Kyanous Stavros General Hospital

location_facility: Istanbul Universitesi - Istanbul Tip Fakultesi Hastanesi

location_facility: London Health Sciences Centre - Victoria Hospital


ReferenceCitation: Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Yang Y, Sievers EL, Kennedy DA, Shustov A. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012 Jun 20;30(18):2190-6. doi: 10.1200/JCO.2011.38.0402. Epub 2012 May 21.

name: Barbara Pro, Fox Chase Cancer Center, Philadelphia, PA; Ranjana Advani, Stanford University Medical Center, Palo Alto, CA; Nancy L. Bartlett, Washington University School of Medicine, St Louis, MO; Joseph D. Rosenblatt, University of Miami, Sylvester Comprehensive Cancer Center, Miami, FL; Tim Illidge, Christie Hospital National Health Service, Manchester, United Kingdom; Jeffrey Matous, Colorado Blood and Cancer Institute, Denver, CO; Radhakrishnan Ramchandren, Karmanos Cancer Institute, Detroit, MI;...

family: Pro

full_name: Barbara Pro

given: Barbara

sequence: first

family: Advani

full_name: Ranjana Advani

given: Ranjana

sequence: additional

family: Brice

full_name: Pauline Brice

given: Pauline

family: Bartlett

full_name: Nancy L. Bartlett

given: Nancy L.

family: Rosenblatt

full_name: Joseph D. Rosenblatt

given: Joseph D.

family: Illidge

full_name: Tim Illidge

given: Tim

family: Matous

full_name: Jeffrey Matous

given: Jeffrey

family: Ramchandren

full_name: Radhakrishnan Ramchandren

given: Radhakrishnan

family: Fanale

full_name: Michelle Fanale

given: Michelle

family: Connors

full_name: Joseph M. Connors

given: Joseph M.

family: Yang

full_name: Yin Yang

given: Yin

family: Sievers

full_name: Eric L. Sievers

given: Eric L.

family: Kennedy

full_name: Dana A. Kennedy

given: Dana A.

family: Shustov

full_name: Andrei Shustov

given: Andrei

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Brentuximab Vedotin (SGN-35) in Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma: Results of a Phase II Study

ReferenceType: derived

ReferenceCitation: Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Fenton K, Huebner D, Pinelli JM, Kennedy DA, Shustov A. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood. 2017 Dec 21;130(25):2709-2717. doi: 10.1182/blood-2017-05-780049. Epub 2017 Oct 3. Erratum in: Blood. 2018 Jul 26;132(4):458-459.

name: Robert H. Lurie Comprehensive Cancer Center, Chicago, IL;

name: Division of Oncology, Stanford University Medical Center, Palo Alto, CA;

name: Hemato-oncology Department, Hospital Saint-Louis, Paris, France;

name: Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO;

name: Division of Hematology-Oncology, Department of Medicine, Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL;

name: Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX;

name: British Columbia Cancer Agency Centre for Lymphoid Cancer, Vancouver, BC, Canada;

name: Millennium Pharmaceuticals, Inc, Cambridge, MA, a wholly owned subsidiary of Takeda Pharmaceuticals Limited; and

name: Division of Hematology, University of Washington School of Medicine, Seattle, WA

location_country:
United States
France
Belgium
Canada
United Kingdom

location_facility: University of Miami Sylvester Comprehensive Cancer Center

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: Baylor Sammons Cancer Center / Texas Oncology

location_facility: MD Anderson Cancer Center / University of Texas

title: A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)

summary: This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.


ReferenceCitation: Emslie GJ, Wells TG, Prakash A, Zhang Q, Pangallo BA, Bangs ME, March JS. Acute and longer-term safety results from a pooled analysis of duloxetine studies for the treatment of children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2015 May;25(4):293-305. doi: 10.1089/cap.2014.0076.

name: Department of Psychiatry, University of Texas Southwestern and Children's Medical Center, Dallas, Texas.

family: Emslie

full_name: Graham J. Emslie

given: Graham J.

name: Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Arkansas.

family: Wells

full_name: Thomas G. Wells

given: Thomas G.

name: Lilly Research Laboratories at Eli Lilly and Company, Indianapolis, Indiana.

family: Prakash

full_name: Apurva Prakash

given: Apurva

family: Zhang

full_name: Qi Zhang

given: Qi

family: Pangallo

full_name: Beth A. Pangallo

given: Beth A.

family: Bangs

full_name: Mark E. Bangs

given: Mark E.

name: Department of Psychiatry, Duke University, Durham, North Carolina.

family: March

full_name: John S. March

given: John S.

journal_name: Journal of Child and Adolescent Psychopharmacology

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

title: Acute and Longer-Term Safety Results from a Pooled Analysis of Duloxetine Studies for the Treatment of Children and Adolescents with Major Depressive Disorder

ReferenceCitation: Atkinson SD, Prakash A, Zhang Q, Pangallo BA, Bangs ME, Emslie GJ, March JS. A double-blind efficacy and safety study of duloxetine flexible dosing in children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2014 May;24(4):180-9. doi: 10.1089/cap.2013.0146. Epub 2014 May 9.

name: Finger Lakes Clinical Research, Rochester, New York.

family: Atkinson

full_name: Sarah D. Atkinson

given: Sarah D.

name: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana.

name: Child and Adolescent Psychiatry Division, University of Texas Southwestern and Children's Medical Center, Dallas, Texas.

name: Division of Neurosciences Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina.

title: A Double-Blind Efficacy and Safety Study of Duloxetine Flexible Dosing in Children and Adolescents with Major Depressive Disorder

ReferenceCitation: Bliznak L, Berg R, Häge A, Dittmann RW. High rate of non-eligibility: methodological factors impacting on recruitment for a multicentre, double-blind study of paediatric patients with major depressive disorder. Pharmacopsychiatry. 2013 Jan;46(1):23-8. doi: 10.1055/s-0032-1314806. Epub 2012 Jun 14.

name: Department of Child and Adolescent Psychiatry and Psychotherapy, Research Unit for Paediatric Psychopharmacology, Central Institute of Mental Health, Mannheim, Germany

family: Bliznak

full_name: L. Bliznak

given: L.

family: Berg

full_name: R. Berg

given: R.

family: Häge

full_name: A. Häge

given: A.

name: Eli Lilly Endowed Chair of Paediatric Psychopharmacology, Central Institute of Mental Health, Mannheim, Germany

family: Dittmann

full_name: R. Dittmann

journal_name: Pharmacopsychiatry

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

title: High Rate of Non-Eligibility: Methodological Factors Impacting on Recruitment for a Multicentre, Double-Blind Study of Paediatric Patients with Major Depressive Disorder

location_country:
United States
South Africa
France
Slovakia
Russian Federation
Germany
Ukraine

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

title: A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder

summary: The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)


ReferenceCitation: Younes A, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Ramchandren R, Bartlett NL, Cheson BD, de Vos S, Forero-Torres A, Moskowitz CH, Connors JM, Engert A, Larsen EK, Kennedy DA, Sievers EL, Chen R. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. J Clin Oncol. 2012 Jun 20;30(18):2183-9. doi: 10.1200/JCO.2011.38.0410. Epub 2012 Mar 26.

name: Anas Younes, The University of Texas MD Anderson Cancer Center, Houston, TX; Ajay K. Gopal, University of Washington/Fred Hutchinson Cancer Research Center, Seattle; Emily K. Larsen, Dana A. Kennedy, and Eric L. Sievers, Seattle Genetics, Bothell, WA; Scott E. Smith, Loyola University Medical Center, Maywood, IL; Stephen M. Ansell, Mayo Clinic, Rochester, MN; Joseph D. Rosenblatt, University of Miami, Miami, FL; Radhakrishnan Ramchandren, Karmanos Cancer Institute, Detroit, MI; Nancy L. Bartlett,...

family: Younes

full_name: Anas Younes

given: Anas

family: Gopal

full_name: Ajay K. Gopal

given: Ajay K.

family: Smith

full_name: Scott E. Smith

given: Scott E.

family: Ansell

full_name: Stephen M. Ansell

given: Stephen M.

family: Rosenblatt

full_name: Joseph D. Rosenblatt

given: Joseph D.

family: Savage

full_name: Kerry J. Savage

given: Kerry J.

family: Ramchandren

full_name: Radhakrishnan Ramchandren

given: Radhakrishnan

family: Bartlett

full_name: Nancy L. Bartlett

given: Nancy L.

family: Cheson

full_name: Bruce D. Cheson

given: Bruce D.

family: de Vos

full_name: Sven de Vos

given: Sven

family: Forero-Torres

full_name: Andres Forero-Torres

given: Andres

family: Moskowitz

full_name: Craig H. Moskowitz

given: Craig H.

family: Connors

full_name: Joseph M. Connors

family: Engert

full_name: Andreas Engert

given: Andreas

family: Larsen

full_name: Emily K. Larsen

given: Emily K.

family: Chen

full_name: Robert Chen

given: Robert

oa_host_type: repository

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: publishedVersion

evidence: oa repository (via pmcid lookup)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Results of a Pivotal Phase II Study of Brentuximab Vedotin for Patients With Relapsed or Refractory Hodgkin's Lymphoma

ReferenceCitation: Chen R, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Huebner D, Fong A, Younes A. Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2016 Sep 22;128(12):1562-6. doi: 10.1182/blood-2016-02-699850. Epub 2016 Jul 18.

name: City of Hope National Medical Center, Duarte, CA;

name: Division of Medical Oncology, Department of Medicine, University of Washington/Fred Hutchinson Cancer Research Center, Seattle, WA;

name: Division of Hematology and Medical Oncology, Department of Medicine, Loyola University Medical Center, Maywood, IL;

name: Division of Hematology and Oncology, Department of Medicine, University of Miami Sylvester Comprehensive Cancer Center, Miami, FL;

name: German Hodgkin Study Group, Department of Internal Medicine I, University Hospital of Cologne, Cologne, Germany;

name: Millenium Pharmaceuticals, Inc., Cambridge, MA; and

name: Memorial Sloan Kettering Cancer Center, New York, NY

ReferenceCitation: Gopal AK, Chen R, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Chi X, Sievers EL, Younes A. Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma. Blood. 2015 Feb 19;125(8):1236-43. doi: 10.1182/blood-2014-08-595801. Epub 2014 Dec 22.

name: British Columbia Cancer Agency Center for Lymphoid Cancer, Vancouver, BC, Canada;

name: Takeda Pharmaceuticals International Company, Cambridge, MA; and

location_country:
Italy
United States
France
Belgium
Canada

location_facility: Washington University School of Medicine

location_facility: Cliniques Universitaires UCL de Mont-Goddine

location_facility: Loyola University Medical Center Cardinal Bernardin Cancer Center

location_facility: Instituto di Ematologia ed Oncologia Medica

title: A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

summary: This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma.


ReferenceType: background

ReferenceCitation: Hirawat S, Welch EM, Elfring GL, Northcutt VJ, Paushkin S, Hwang S, Leonard EM, Almstead NG, Ju W, Peltz SW, Miller LL. Safety, tolerability, and pharmacokinetics of PTC124, a nonaminoglycoside nonsense mutation suppressor, following single- and multiple-dose administration to healthy male and female adult volunteers. J Clin Pharmacol. 2007 Apr;47(4):430-44.

ReferenceCitation: Welch EM, Barton ER, Zhuo J, Tomizawa Y, Friesen WJ, Trifillis P, Paushkin S, Patel M, Trotta CR, Hwang S, Wilde RG, Karp G, Takasugi J, Chen G, Jones S, Ren H, Moon YC, Corson D, Turpoff AA, Campbell JA, Conn MM, Khan A, Almstead NG, Hedrick J, Mollin A, Risher N, Weetall M, Yeh S, Branstrom AA, Colacino JM, Babiak J, Ju WD, Hirawat S, Northcutt VJ, Miller LL, Spatrick P, He F, Kawana M, Feng H, Jacobson A, Peltz SW, Sweeney HL. PTC124 targets genetic disorders caused by nonsense mutations. Nature. 2007 May 3;447(7140):87-91. Epub 2007 Apr 22.

intervention_type: Drug

status: Terminated

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: PTC Therapeutics

enrollment_type: Actual

primary_purpose: Treatment

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

location_facility: U.O. Complessa di Neuropsichiatria Infantile-Policlinico A. Gemelli-Universita Cattolica

location_facility: Department of Rehabilitation, The Children's Hospital

location_facility: University of Essen - Clinic for Children

location_facility: Robert Jones & Agnes Hunt Orthopaedic Hospital

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of Iowa Children's Hospital, Division of Child Neurology

location_facility: UCL Instititute of Child Health, Dubowitz

location_facility: Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: Groupe Hospitalier Pitie-Salpetriere, Institut de Myologie

ipd_sharing: No

study_completion_date_type: Actual

source: euctr

title: A Phase 2B Extension Study of PTC124 in Subjects With Nonsense-Mutation-Mediated Duchenne and Becker Muscular Dystrophy

summary: Duchenne/Becker muscular dystrophy (DMD/BMD) is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability during childhood and teenage years. A specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of DMD/BMD in approximately 10-15% of boys with the disease. Ataluren (PTC124) is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 2b extension trial that will evaluate the long-term safety of ataluren (PTC124) in boys with nonsense mutation DMD/BMD, as determined by adverse events and laboratory abnormalities. The study will also assess changes in walking, muscle function, and other important clinical and laboratory measures.

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the Pancreas

summary: Phase III Metastatic Pancreatic Cancer

status: Completed

design_allocation: Randomized

ReferenceCitation: Tabernero J, Chiorean EG, Infante JR, Hingorani SR, Ganju V, Weekes C, Scheithauer W, Ramanathan RK, Goldstein D, Penenberg DN, Romano A, Ferrara S, Von Hoff DD. Prognostic factors of survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Oncologist. 2015 Feb;20(2):143-50. doi: 10.1634/theoncologist.2014-0394. Epub 2015 Jan 12.

ReferenceCitation: Chiorean EG, Von Hoff DD, Tabernero J, El-Maraghi R, Ma WW, Reni M, Harris M, Whorf R, Liu H, Li JS, Manax V, Romano A, Lu B, Goldstein D. Second-line therapy after nab-paclitaxel plus gemcitabine or after gemcitabine for patients with metastatic pancreatic cancer. Br J Cancer. 2016 Jul 12;115(2):188-94. doi: 10.1038/bjc.2016.185. Epub 2016 Jun 28. Erratum in: Br J Cancer. 2016 Oct 25;115(9):e13.

ReferenceCitation: Tehfe M, Dowden S, Kennecke H, El-Maraghi R, Lesperance B, Couture F, Letourneau R, Liu H, Romano A. nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma: Canadian Subgroup Analysis of the Phase 3 MPACT Trial. Adv Ther. 2016 May;33(5):747-59. doi: 10.1007/s12325-016-0327-4. Epub 2016 Apr 16. Erratum in: Adv Ther. 2016 Nov 24;:.

ReferenceCitation: Scheithauer W, Ramanathan RK, Moore M, Macarulla T, Goldstein D, Hammel P, Kunzmann V, Liu H, McGovern D, Romano A, Von Hoff DD. Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial. J Gastrointest Oncol. 2016 Jun;7(3):469-78. doi: 10.21037/jgo.2016.01.03.

ReferenceCitation: Vogel A, Römmler-Zehrer J, Li JS, McGovern D, Romano A, Stahl M. Efficacy and safety profile of nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic cancer treated to disease progression: a subanalysis from a phase 3 trial (MPACT). BMC Cancer. 2016 Oct 21;16(1):817.

ReferenceCitation: Kunzmann V, Ramanathan RK, Goldstein D, Liu H, Ferrara S, Lu B, Renschler MF, Von Hoff DD. Tumor Reduction in Primary and Metastatic Pancreatic Cancer Lesions With nab-Paclitaxel and Gemcitabine: An Exploratory Analysis From a Phase 3 Study. Pancreas. 2017 Feb;46(2):203-208. doi: 10.1097/MPA.0000000000000742.

ReferenceCitation: Tabernero J, Kunzmann V, Scheithauer W, Reni M, Shiansong Li J, Ferrara S, Djazouli K. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: a subgroup analysis of the Western European cohort of the MPACT trial. Onco Targets Ther. 2017 Feb 2;10:591-596. doi: 10.2147/OTT.S124097. eCollection 2017.

ReferenceCitation: Ramanathan RK, Goldstein D, Korn RL, Arena F, Moore M, Siena S, Teixeira L, Tabernero J, Van Laethem JL, Liu H, McGovern D, Lu B, Von Hoff DD. Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas. Ann Oncol. 2016 Apr;27(4):648-53. doi: 10.1093/annonc/mdw020. Epub 2016 Jan 22.

family: Ramanathan

full_name: R.K. Ramanathan

family: Goldstein

full_name: D. Goldstein

given: D.

family: Korn

full_name: R.L. Korn

family: Arena

full_name: F. Arena

given: F.

family: Moore

full_name: M. Moore

given: M.

family: Siena

full_name: S. Siena

given: S.

family: Teixeira

full_name: L. Teixeira

given: L.

family: Tabernero

full_name: J. Tabernero

given: J.

family: Van Laethem

full_name: J.-L. Van Laethem

family: Liu

full_name: H. Liu

given: H.

family: McGovern

full_name: D. McGovern

family: Lu

full_name: B. Lu

given: B.

family: Von Hoff

full_name: D.D. Von Hoff

journal_name: Annals of Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

evidence: oa repository (semantic scholar lookup)

ReferenceCitation: Chiorean EG, Von Hoff DD, Reni M, Arena FP, Infante JR, Bathini VG, Wood TE, Mainwaring PN, Muldoon RT, Clingan PR, Kunzmann V, Ramanathan RK, Tabernero J, Goldstein D, McGovern D, Lu B, Ko A. CA19-9 decrease at 8 weeks as a predictor of overall survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Ann Oncol. 2016 Apr;27(4):654-60. doi: 10.1093/annonc/mdw006. Epub 2016 Jan 22.

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

repository_institution: American Medical Association - The Journal of the American Medical Association (JAMA) Network

repository_institution: Würzburg University - Online Publication Service of Würzburg University

ReferenceCitation: Goldstein D, Von Hoff DD, Moore M, Greeno E, Tortora G, Ramanathan RK, Macarulla T, Liu H, Pilot R, Ferrara S, Lu B. Development of peripheral neuropathy and its association with survival during treatment with nab-paclitaxel plus gemcitabine for patients with metastatic adenocarcinoma of the pancreas: A subset analysis from a randomised phase III trial (MPACT). Eur J Cancer. 2016 Jan;52:85-91. doi: 10.1016/j.ejca.2015.10.017. Epub 2015 Dec 1.

ReferenceCitation: Portal A, Pernot S, Tougeron D, Arbaud C, Bidault AT, de la Fouchardière C, Hammel P, Lecomte T, Dréanic J, Coriat R, Bachet JB, Dubreuil O, Marthey L, Dahan L, Tchoundjeu B, Locher C, Lepère C, Bonnetain F, Taieb J. Nab-paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma after Folfirinox failure: an AGEO prospective multicentre cohort. Br J Cancer. 2015 Sep 29;113(7):989-95. doi: 10.1038/bjc.2015.328. Epub 2015 Sep 15.

ReferenceCitation: Goldstein D, El-Maraghi RH, Hammel P, Heinemann V, Kunzmann V, Sastre J, Scheithauer W, Siena S, Tabernero J, Teixeira L, Tortora G, Van Laethem JL, Young R, Penenberg DN, Lu B, Romano A, Von Hoff DD. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial. J Natl Cancer Inst. 2015 Jan 31;107(2). pii: dju413. doi: 10.1093/jnci/dju413. Print 2015 Feb.

journal_name: JNCI Journal of the National Cancer Institute

title: nab-Paclitaxel Plus Gemcitabine for Metastatic Pancreatic Cancer: Long-Term Survival From a Phase III Trial

ReferenceCitation: Vogel A, Pelzer U, Salah-Eddin AB, Köster W. First-line nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer from routine clinical practice. In Vivo. 2014 Nov-Dec;28(6):1135-40.

ReferenceCitation: Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.

title: Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine

ReferenceCitation: Von Hoff DD, Cridebring D, Tian OY, Han H, Bhore R, Franco T, Ondovik MS, Louis CU. Analysis of the Role of Plasma 25-Hydroxyvitamin D Levels in Survival Outcomes in Patients from the Phase III MPACT Trial of Metastatic Pancreatic Cancer. Oncologist. 2021 Apr;26(4):e704-e709. doi: 10.1002/onco.13645. Epub 2021 Jan 11.

name: Molecular Medicine Division, Translational Genomics Research Institute  Phoenix Arizona USA

name: Bristol Myers Squibb Company  Princeton New Jersey USA

title: Analysis of the Role of Plasma 25‐Hydroxyvitamin D Levels in Survival Outcomes in Patients from the Phase III MPACT Trial of Metastatic Pancreatic Cancer

ReferenceCitation: McCleary-Wheeler AL, McWilliams R, Fernandez-Zapico ME. Aberrant signaling pathways in pancreatic cancer: a two compartment view. Mol Carcinog. 2012 Jan;51(1):25-39. doi: 10.1002/mc.20827.

title: Aberrant signaling pathways in pancreatic cancer: A two compartment view

location_country:
Italy
Austria
United States
Germany
France
Australia
Belgium
Russian Federation
Spain
Canada
Ukraine

location_facility: Central Clinical Hosp of the President of the Russian Federation

location_facility: Texas Oncology, PA/ Methodist Charlton Cancer Center

location_facility: Centre Hospitalier de L'Universite de Montreal St-Luc

location_facility: Northern Arizona Hematology and Oncology Associates-AOA

location_facility: Volyn Regional Oncology Center Department of Oncochemotherapy

location_facility: Haemotology & Oncology Australasia (HOCA)

location_facility: Lviv Regional Diagnostics and Treatment and Diagnostics Onc Ctr

location_facility: I.R.C.C.S. "Giovanni Paolo II" - Istituto Oncologico

location_facility: Arizona Cancer Center, University of Arizona

location_facility: UAB Comprenhensive Cancer Center at University of Alabama

location_facility: Kirovohrad Regional Oncology Center, Department of Chemotherapy

location_facility: National Institute of Cancer, Department of Tumors of Abdominal Cavity and Retroperitoneum

location_facility: Fairfax-Northern Virginia Hematology-Oncology, P.C.

location_facility: Adelaide Cancer Centre (T/A Ashford Cancer Ctr)

location_facility: Azienda Ospedaliero universitaria Pisana

location_facility: Praxis für Innere Medizin, Dr. Oettle Helmut

location_facility: O.F. Herbachevskyi Regional Clinical Hospital, Surgery Center

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Istituto Nazionale Tumori "Regina Elena"

location_facility: Zaporizhia Medical Academy of Postgraduate Education

location_facility: Clearview Cancer Institute Oncology Specialities, P.C.

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: University of Oklahoma Health Science Center

location_facility: The University of Texas Medical School at Houston

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Cancer Care & Hematology Specialists of Chicagoland

location_facility: Pyatigorsk Affiliate of Stavropol Regional Onc Ctr

location_facility: South Texas Oncology and Hematology, P.A

location_facility: St. Petersburg State Med Academy n.a.Mechnikov

location_facility: The Center for Cancer and Hematologic Disease

location_facility: TGEN Clinical Research Services at Scottsdale Healthcare

location_facility: Centre Regional de lutte contre le cancer Paul Papin

location_facility: Sidney Kimmel Comphrensive Cancer Center, John Hopkins University

location_facility: Russian Res Ctr of Radiology under the Fed Agency for Hi-Tech Med Care

location_facility: Cancer Center of Excellence/University of MA Medical School

location_facility: Ospedale Casa Sollievo della Sofferenza IRCCS

location_facility: Moscow City Clinical Hosp #57 Chemotherapy Dept

location_facility: Kyiv City Clinical Hospital #10, Center for Hepatic, Bile Duct and Pancreatic Surgery

location_facility: Desert Hematology Oncology Medical Group, Inc.

location_facility: Arcispedale Santa Maria Nuova, Unità Operativa di Oncologia Medica

location_facility: E. O. Ospedali Galliera, Struttura Complessa Oncologia Medica

location_facility: The Center for Cancer and Blood Disorders

location_facility: Cancer Care & Hemaotology Specialists of Chicagoland

location_facility: University of Minnesota, Masonic Cancer Center

location_facility: St. Mary Medical Center Hem-Onc Group, PC

location_facility: Russian Research Ctr of Surgery n.a. B.V. Petrovskiy under the Russian Academy of Med Sciences

location_facility: Russian Research Ctr for Radiology and Surgical Technologies

location_facility: Med Radiological Centre of the Russian Academy of Med Sciences

location_facility: Haematology Oncology Clinics of Australasia-Gold Coast

location_facility: Chattanooga Oncology Hematology Associates


title: Oral Direct Factor Xa Inhibitor BAY 59-7939 in the Prevention of VTE in Patients Undergoing Total Hip Replacement. ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial

acronym: ODiXaHip

summary: Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE (up to 60 % without prophylaxis). The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied below the skin (subcutaneously). Additionally, there is a chance of developing a heparin-induced thrombocytopenia (decrease in platelets). Therefore, there is still a need for new agents which are safer and more efficient and which are easier to apply.The purpose of this study is to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug Enoxaparin. Enoxaparin, a so-called low molecular heparin, is approved and widely used in the area of thromboprophylaxis and will be given once daily subcutaneously.Another important purpose of the study is to find the optimal dose of BAY 59-7939 for thromboprophylaxis after hip replacement surgery. Therefore, there are several dose steps planned.

primary_purpose: Prevention

lead_sponsor: Bayer

location_country:
Austria
Sweden
Netherlands
France
Poland
Israel
Norway
Belgium
Denmark
Germany
United Kingdom

status_simplified: Completed


title: An Open-Label, Multi-Centre, Randomised, Phase Ib Study to Investigate the Safety and Efficacy of RO5072759 Given in Combination With CHOP, FC or Bendamustine Chemotherapy in Patients With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma

acronym: GAUDI

summary: This open-label, randomized, phase Ib study will assess the safety and efficacy of obinutuzumab given in combination with FC (fludarabine and cyclophosphamide) or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) or bendamustine induction chemotherapy in participants with Cluster of Differentiation (CD) 20+ B-cell Follicular Lymphoma (FL). Participants with complete response or partial response after induction therapy may receive maintenance therapy every 3 months for 2 years or until disease progression, whichever comes first. All participants in the induction period of the study will have a safety follow-up visit 28 days after completing the last dose of obinutuzumab + chemotherapy, and will be followed for at least 2 years, unless they are being treated in maintenance or discontinue from the study prior to this time point. Participants who complete/discontinue maintenance therapy will also be followed for a period of 2 years after receiving the last dose of obinutuzumab or until progression/new antilymphoma treatment.

ReferenceCitation: Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.

family: Gibiansky

full_name: Ekaterina Gibiansky

given: Ekaterina

full_name: Leonid Gibiansky

given: Leonid

name: Pharma Research and Early DevelopmentRoche Innovation Center Basel Basel Switzerland

family: Buchheit

full_name: Vincent Buchheit

given: Vincent

family: Frey

full_name: Nicolas Frey

given: Nicolas

name: Clinical DevelopmentRoche Innovation Center Welwyn Welwyn Garden City UK

family: Brewster

full_name: Michael Brewster

given: Michael

name: Pharma Development Clinical OncologyF. Hoffmann‐La Roche Ltd Basel Switzerland

family: Fingerle‐Rowson

full_name: Günter Fingerle‐Rowson

given: Günter

family: Jamois

full_name: Candice Jamois

given: Candice

journal_name: British Journal of Clinical Pharmacology

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab‐refractory follicular lymphoma patients in the GADOLIN phase III study

ReferenceCitation: Grigg A, Dyer MJ, Díaz MG, Dreyling M, Rule S, Lei G, Knapp A, Wassner-Fritsch E, Marlton P. Safety and efficacy of obinutuzumab with CHOP or bendamustine in previously untreated follicular lymphoma. Haematologica. 2017 Apr;102(4):765-772. doi: 10.3324/haematol.2016.152272. Epub 2016 Dec 23.

family: Grigg

full_name: Andrew Grigg

given: Andrew

family: Dyer

full_name: Martin J.S. Dyer

given: Martin J.S.

family: Díaz

full_name: Marcos González Díaz

given: Marcos González

family: Dreyling

full_name: Martin Dreyling

given: Martin

family: Rule

full_name: Simon Rule

given: Simon

family: Lei

full_name: Guiyuan Lei

given: Guiyuan

family: Knapp

full_name: Andrea Knapp

given: Andrea

family: Wassner-Fritsch

full_name: Elisabeth Wassner-Fritsch

given: Elisabeth

family: Marlton

full_name: Paula Marlton

given: Paula

repository_institution: University of Leicester - Leicester Research Archive

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Cartron G, Hourcade-Potelleret F, Morschhauser F, Salles G, Wenger M, Truppel-Hartmann A, Carlile DJ. Rationale for optimal obinutuzumab/GA101 dosing regimen in B-cell non-Hodgkin lymphoma. Haematologica. 2016 Feb;101(2):226-34. doi: 10.3324/haematol.2015.133421. Epub 2015 Dec 11.

ReferenceCitation: Radford J, Davies A, Cartron G, Morschhauser F, Salles G, Marcus R, Wenger M, Lei G, Wassner-Fritsch E, Vitolo U. Obinutuzumab (GA101) plus CHOP or FC in relapsed/refractory follicular lymphoma: results of the GAUDI study (BO21000). Blood. 2013 Aug 15;122(7):1137-43. doi: 10.1182/blood-2013-01-481341. Epub 2013 Jul 10.

name: The University of Manchester and Christie National Health Service Foundation Trust, Manchester, United Kingdom;

name: Cancer Sciences Unit, University of Southampton Faculty of Medicine, Southampton, United Kingdom;

name: Centre Hospitalier Universitaire Montpellier, Montpellier, France;

name: Centre Hospitalier Régional Universitaire de Lille, Lille, France;

name: Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Lyon, France;

name: King’s College Hospital, London, United Kingdom;

name: F. Hoffmann-La Roche Ltd., Basel, Switzerland;

name: Roche Products Ltd., Welwyn Garden City, United Kingdom; and

name: Azienda Ospedaliera Città della Salute e della Scienza, Torino, Italy

repository_institution: The University of Manchester - Research Explorer

location_country:
Italy
France
Australia
Spain
Germany
United Kingdom


lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Austria
Brazil
Switzerland
Netherlands
France
Slovakia
Norway
Singapore
Argentina
Australia
Belgium
Spain
Germany
Czech Republic
Taiwan
Colombia

type: EudraCT Number

title: An Extension to a 12-month, Open-label, Randomised, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Cyclosporine in Combination With Everolimus, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients

summary: This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.


title: A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension

summary: This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed.

design_allocation: Non-Randomized

lead_sponsor: Pfizer

location_country:
Italy
Austria
Brazil
Mexico
Netherlands
Germany
France
Poland
Israel
Argentina
Australia
Belgium
Spain
United States
United Kingdom
Canada


type: Other Identifier

title: A Safety and Efficacy Study of Blood Pressure Control in Acute Heart Failure - A Pilot Study (PRONTO)

acronym: PRONTO

summary: The purpose of this study was to evaluate the efficacy and safety of intravenous (IV) clevidipine as compared with standard of care IV antihypertensive agents for blood pressure (BP) lowering in patients with acute heart failure and elevated BP.

lead_sponsor: The Medicines Company

location_country:
Germany
United States
France

location_facility: Louisiana State University Health Sciences Center - Emergency Medicine

location_facility: Stony Brook University and Medical Center

location_facility: Hopital AP-HP Lariboisiere Urgencies-SMUR

location_facility: Washington University School of Medicine


ReferenceCitation: Kerem E, Konstan MW, De Boeck K, Accurso FJ, Sermet-Gaudelus I, Wilschanski M, Elborn JS, Melotti P, Bronsveld I, Fajac I, Malfroot A, Rosenbluth DB, Walker PA, McColley SA, Knoop C, Quattrucci S, Rietschel E, Zeitlin PL, Barth J, Elfring GL, Welch EM, Branstrom A, Spiegel RJ, Peltz SW, Ajayi T, Rowe SM; Cystic Fibrosis Ataluren Study Group. Ataluren for the treatment of nonsense-mutation cystic fibrosis: a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Respir Med. 2014 Jul;2(7):539-47. doi: 10.1016/S2213-2600(14)70100-6. Epub 2014 May 15.

family: Kerem

full_name: Eitan Kerem

given: Eitan

family: Konstan

full_name: Michael W Konstan

given: Michael W

family: De Boeck

full_name: Kris De Boeck

given: Kris

family: Accurso

full_name: Frank J Accurso

given: Frank J

family: Sermet-Gaudelus

full_name: Isabelle Sermet-Gaudelus

given: Isabelle

family: Wilschanski

full_name: Michael Wilschanski

family: Elborn

full_name: J Stuart Elborn

given: J Stuart

family: Melotti

full_name: Paola Melotti

given: Paola

family: Bronsveld

full_name: Inez Bronsveld

given: Inez

family: Fajac

full_name: Isabelle Fajac

family: Malfroot

full_name: Anne Malfroot

given: Anne

family: Rosenbluth

full_name: Daniel B Rosenbluth

given: Daniel B

family: Walker

full_name: Patricia A Walker

given: Patricia A

family: McColley

full_name: Susanna A McColley

given: Susanna A

family: Knoop

full_name: Christiane Knoop

given: Christiane

family: Quattrucci

full_name: Serena Quattrucci

given: Serena

family: Rietschel

full_name: Ernst Rietschel

given: Ernst

family: Zeitlin

full_name: Pamela L Zeitlin

given: Pamela L

family: Barth

full_name: Jay Barth

given: Jay

family: Elfring

full_name: Gary L Elfring

given: Gary L

family: Welch

full_name: Ellen M Welch

given: Ellen M

family: Branstrom

full_name: Arthur Branstrom

given: Arthur

family: Spiegel

full_name: Robert J Spiegel

given: Robert J

family: Peltz

full_name: Stuart W Peltz

given: Stuart W

family: Ajayi

full_name: Temitayo Ajayi

given: Temitayo

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

location_facility: Hadassah University Hospital - Mount Scopus

location_facility: Karolinska University Hospital, Huddinge

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

title: A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis

summary: Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of mutation called a nonsense (premature stop codon) mutation is the cause of CF in approximately 10% of patients with the disease. Ataluren is an orally delivered investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 3 trial that will evaluate the clinical benefit of ataluren in adult and pediatric participants with CF due to a nonsense mutation. The main goals of the study are to understand whether ataluren can improve pulmonary function and whether the drug can safely be given for a long period of time. The study will also assess the effects of ataluren on CF pulmonary exacerbation frequency, cough frequency, health-related quality of life, antibiotic use for CF-related infections, CF-related disruptions to daily living, body weight, and CF pathophysiology.


title: Controlled, Randomized, Prospective, Double-Blind, Multicenter, Phase I/II, Dose-Escalation Study of the Safety, PK, and Clinical Activity of I5NP for Prophylaxis of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation

summary:
The purpose of this study is to determine whether a single administration of QPI-1002 (also known as I5NP) can prevent DGF in patients undergoing deceased donor kidney transplantation. In this Phase I /II study, patients who are undergoing renal transplantation with organs from DCD donors, ECD donors or SCD donors with ≥ 24 hours of cold ischemia time who meet study entry criteria will be studied to evaluate the safety and pharmacokinetic profile of I5NP (Part A) and clinical activity of I5NP administration (Part B). Data from this study will be used to identify doses of I5NP to be used in follow-on efficacy studies.

Part A will be a randomized, dose escalation study to determine the highest or maximum tolerated dose (MTD). Part A will enroll 40 patients at approximately 20 sites; patients will be randomized to receive either I5NP or placebo in a ratio of 8:2 in each cohort (cohorts 1-4).

Part B will utilize the dose identified in Part A to further evaluate, in a double-blind manner, the safety, and clinical activity of I5NP. In Part B, up to 326 patients will participate at approximately 60 sites; up to 163 patients will be randomized to receive I5NP and up to 163 patients randomized to receive placebo.

lead_sponsor: Quark Pharmaceuticals

location_country:
United States
France
Spain
Germany
Canada

location_facility: University of Colorado Health Science Center

location_facility: Transplant Research Institute (TRI; formerly NIT)

location_facility: QE II Capital District Health Authority, Halifax


ReferenceCitation: Jeppesen PB, Sanguinetti EL, Buchman A, Howard L, Scolapio JS, Ziegler TR, Gregory J, Tappenden KA, Holst J, Mortensen PB. Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients. Gut. 2005 Sep;54(9):1224-31.

ReferenceCitation: Jeppesen PB, Gabe SM, Seidner DL, Lee HM, Olivier C. Citrulline correlations in short bowel syndrome-intestinal failure by patient stratification: Analysis of 24 weeks of teduglutide treatment from a randomized controlled study. Clin Nutr. 2020 Aug;39(8):2479-2486. doi: 10.1016/j.clnu.2019.11.001. Epub 2019 Nov 9.

family: Jeppesen

full_name: Palle Bekker Jeppesen

given: Palle Bekker

family: Gabe

full_name: Simon M. Gabe

given: Simon M.

family: Seidner

full_name: Douglas L. Seidner

given: Douglas L.

family: Lee

full_name: Hak-Myung Lee

given: Hak-Myung

family: Olivier

full_name: Clément Olivier

given: Clément

journal_name: Clinical Nutrition

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Citrulline correlations in short bowel syndrome–intestinal failure by patient stratification: Analysis of 24 weeks of teduglutide treatment from a randomized controlled study

ReferenceCitation: Jeppesen PB, Gabe SM, Seidner DL, Lee HM, Olivier C. Factors Associated With Response to Teduglutide in Patients With Short-Bowel Syndrome and Intestinal Failure. Gastroenterology. 2018 Mar;154(4):874-885. doi: 10.1053/j.gastro.2017.11.023. Epub 2017 Nov 22.

full_name: Palle B. Jeppesen

given: Palle B.

journal_name: Gastroenterology

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

repository_normalized: Pure (Denmark)

ReferenceCitation: Fujioka K, Jeejeebhoy K, Pape UF, Li B, Youssef NN, Schneider SM. Patients With Short Bowel on Narcotics During 2 Randomized Trials Have Abdominal Complaints Independent of Teduglutide. JPEN J Parenter Enteral Nutr. 2017 Nov;41(8):1419-1422. doi: 10.1177/0148607116663481. Epub 2016 Aug 9.

name: Department of Diabetes and Endocrinology, Scripps Clinic, San Diego, California, USA

family: Fujioka

full_name: Ken Fujioka

given: Ken

name: Department of Medicine, St. Michael’s Hospital, Toronto, Ontario, Canada

family: Jeejeebhoy

full_name: Khursheed Jeejeebhoy

given: Khursheed

name: Department of Hepatology & Gastroenterology, Charité University Medicine, Berlin, Germany

family: Pape

full_name: Ulrich-Frank Pape

given: Ulrich-Frank

name: Department of Statistics, NPS Pharmaceuticals, Inc., Lexington, Massachusetts, USA

name: Amicus Therapeutics, Cranbury, New Jersey, USA, for BL and Digestive Healthcare Center, Hillsborough, New Jersey, USA, for NNY

family: Li

full_name: Benjamin Li

given: Benjamin

name: Clinical Research and Development, NPS Pharmaceuticals, Inc., Lexington, Massachusetts, USA

family: Youssef

full_name: Nader N. Youssef

given: Nader N.

name: Gastroenterology and Clinical Nutrition, University of Nice-Sophia Antipolis, Nice, France

journal_name: Journal of Parenteral and Enteral Nutrition

ReferenceCitation: Vipperla K, O'Keefe SJ. Study of teduglutide effectiveness in parenteral nutrition-dependent short-bowel syndrome subjects. Expert Rev Gastroenterol Hepatol. 2013 Nov;7(8):683-7. doi: 10.1586/17474124.2013.842894. Epub 2013 Oct 17. Review.

journal_name: Expert Review of Gastroenterology & Hepatology

ReferenceCitation: Jeppesen PB, Pertkiewicz M, Forbes A, Pironi L, Gabe SM, Joly F, Messing B, Loth S, Youssef NN, Heinze H, Berghöfer P. Quality of life in patients with short bowel syndrome treated with the new glucagon-like peptide-2 analogue teduglutide--analyses from a randomised, placebo-controlled study. Clin Nutr. 2013 Oct;32(5):713-21. doi: 10.1016/j.clnu.2013.03.016. Epub 2013 Mar 28.

title: Quality of life in patients with short bowel syndrome treated with the new glucagon-like peptide-2 analogue teduglutide – Analyses from a randomised, placebo-controlled study

ReferenceCitation: Berghöfer P, Fragkos KC, Baxter JP, Forbes A, Joly F, Heinze H, Loth S, Pertkiewicz M, Messing B, Jeppesen PB. Development and validation of the disease-specific Short Bowel Syndrome-Quality of Life (SBS-QoL™) scale. Clin Nutr. 2013 Oct;32(5):789-96. doi: 10.1016/j.clnu.2012.12.001. Epub 2012 Dec 12.

ReferenceCitation: Jeppesen PB, Pertkiewicz M, Messing B, Iyer K, Seidner DL, O'keefe SJ, Forbes A, Heinze H, Joelsson B. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology. 2012 Dec;143(6):1473-1481.e3. doi: 10.1053/j.gastro.2012.09.007. Epub 2012 Sep 11.

title: Teduglutide Reduces Need for Parenteral Support Among Patients With Short Bowel Syndrome With Intestinal Failure

location_country:
Italy
Netherlands
Germany
France
Poland
Spain
Denmark
United States
United Kingdom
Canada

location_facility: Universitair Medisch Centrum St. Radboud

location_facility: Samodzielny Publiczny Szpital Kliniczny im. prof W. Orlowskiego CMKP, Oddzial Kliniczny Zywienia i Chirurgii

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej

location_facility: Critical Care Research, Royal Alexandra Hospital

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego

location_facility: Green Area, Main Hospital Salford Royal Hospitals NHS Foundation Trust

location_facility: Policlinico Sant'Orsola - Malpighi centro insufficienza intestinale

location_facility: Azienda Universitaria Policlinico Federico II

location_facility: Rigshospitalet - Abdominalcentret, Hepatologisk Kilinik A

location_facility: University Health Network - Toronto General Hospital

location_facility: Med. Klinik m.S. Hepatologie und Gastroenterologie

location_facility: Azienda Ospedaliera Universitaria S. Giovanni Battista - Le Molinette

location_facility: Polyclinic Family and Specialty Medicine Facility

location_facility: Hôpital Croix Rousse Unité de Nutrition Clinique Intensive

title: A 24-Week Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

summary: Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.


title: An Open-label Study to Determine the Effect of R1507 Plus Tarceva (Erlotinib) on Progression-free Survival in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) With Progressive Disease After Clinical Benefit to Second or Third Line Tarceva Monotherapy.

summary: This single arm study in patients with advanced Stage IIIb/IV NSCLC who have progressive disease after deriving clinical benefit (defined as response or stable disease after 12 weeks) from second or third line Tarceva monotherapy will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva. Patients will receive R1507 (9mg/kg iv) weekly in combination with Tarceva (150mg oral daily) for up to a maximum of 24 months. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
United States
Canada
France
Poland


lead_sponsor: H. Lundbeck A/S

location_country:
Hong Kong
Philippines
France
Poland
Thailand
Spain
Indonesia
Czech Republic

title: A Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Exploring the Efficacy and Safety of 12 Weeks Treatment With Lu 31-130 in Patients With Schizophrenia

summary: The main purpose with the study is to explore the efficacy and safety of Lu 31-130 in patients suffering from schizophrenia compared to a standard antipsychotic drug.


title: A Multicenter, Randomized, Open-Label, Active-Controlled Pilot Study to Evaluate the Safety and Antiretroviral Activity of Unboosted Atazanavir BID Plus Raltegravir BID and Boosted Atazanavir QD in Combination With Tenofovir/Emtricitabine QD in Treatment Naive HIV-Infected Subjects

acronym: SPARTAN

summary: The purpose of this study is to determine if the combination of atazanavir and raltegravir taken together is safe and effective in the treatment of human immunodeficiency virus (HIV).

ReferenceCitation: Kozal MJ, Lupo S, DeJesus E, Molina JM, McDonald C, Raffi F, Benetucci J, Mancini M, Yang R, Wirtz V, Percival L, Zhang J, Zhu L, Arikan D, Farajallah A, Nguyen BY, Leavitt R, McGrath D, Lataillade M, The Spartan Study Team. A nucleoside- and ritonavir-sparing regimen containing atazanavir plus raltegravir in antiretroviral treatment-naïve HIV-infected patients: SPARTAN study results. HIV Clin Trials. 2012 May-Jun;13(3):119-30. doi: 10.1310/hct1303-119.

family: Kozal

full_name: Michael J. Kozal

given: Michael J.

family: Lupo

full_name: Sergio Lupo

given: Sergio

family: DeJesus

full_name: Edwin DeJesus

given: Edwin

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: McDonald

full_name: Cheryl McDonald

given: Cheryl

family: Raffi

full_name: Francois Raffi

given: Francois

family: Benetucci

full_name: Jorge Benetucci

given: Jorge

family: Mancini

full_name: Marco Mancini

given: Marco

family: Yang

full_name: Rong Yang

given: Rong

family: Wirtz

full_name: Victoria Wirtz

given: Victoria

family: Percival

full_name: Lisa Percival

given: Lisa

family: Zhang

full_name: Jenny Zhang

given: Jenny

family: Zhu

full_name: Li Zhu

given: Li

family: Arikan

full_name: Dilek Arikan

given: Dilek

family: Farajallah

full_name: Awny Farajallah

given: Awny

family: Nguyen

full_name: Bach-Yen Nguyen

given: Bach-Yen

family: Leavitt

full_name: Randi Leavitt

given: Randi

family: McGrath

full_name: Donnie McGrath

given: Donnie

family: Lataillade

full_name: Max Lataillade

given: Max

journal_name: HIV Clinical Trials

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: A Nucleoside- and Ritonavir-Sparing Regimen Containing Atazanavir Plus Raltegravir in Antiretroviral Treatment-Naïve HIV-Infected Patients: SPARTAN Study Results

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
Argentina
France

location_facility: Tarrant County Infectious Disease Associates


title: A Randomized, Double-Blind, Multi-Center Phase II Trial of Exemestane (AromasinÂ®) Plus Dasatinib Versus Exemestane Plus Placebo in Advanced Estrogen Receptor-Positive Breast Cancer After Disease Progression on a Non-Steroidal Aromatase Inhibitor (NSAI)

summary: The purpose of this study is to determine whether exemestane plus dasatinib will be well-tolerated and will increase progression-free survival (PFS) in the treatment of advanced estrogen-receptor positive (ER+) breast cancer after disease progression (PD) on a non-steroidal aromatase inhibitor (NSAI).

location_country:
Sweden
United Kingdom
France
Poland
Ireland
Spain
United States
Czech Republic

location_facility: Compassionate Cancer Care Medical Group, Inc

location_facility: Compassionate Cancer Care Medical Group Inc


title: A Prospective, Multicenter, Double-blind, Randomized, Comparative Study to Estimate the Safety, Tolerability and Efficacy of NXL104/Ceftazidime Plus Metronidazole vs. Meropenem in the Treatment of Complicated Intra-abdominal Infections in Hospitalized Adults

summary: The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated intra-abdominal infections as compared to a comparator group.

ReferenceCitation: Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11). pii: e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.

name: AstraZeneca, Waltham, Massachusetts, USA

family: Nichols

full_name: Wright W. Nichols

given: Wright W.

family: Stone

full_name: Gregory G. Stone

given: Gregory G.

name: AstraZeneca, Macclesfield, United Kingdom

family: Newell

full_name: Paul Newell

given: Paul

family: Broadhurst

full_name: Helen Broadhurst

given: Helen

family: Wardman

full_name: Angela Wardman

given: Angela

name: Wright Dose Ltd., Altrincham, United Kingdom

family: MacPherson

full_name: Merran MacPherson

given: Merran

family: Yates

full_name: Katrina Yates

given: Katrina

family: Riccobene

full_name: Todd Riccobene

given: Todd

family: Critchley

full_name: Ian A. Critchley

given: Ian A.

family: Das

full_name: Shampa Das

given: Shampa

journal_name: Antimicrobial Agents and Chemotherapy

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

location_country:
India
Lebanon
France
Bulgaria
Poland
Romania
Russian Federation
United States

location_facility: CCB Ministry of Interior Clinical of Surgery

location_facility: Cedars-Sinai Medical Center Dept of Surgery

location_facility: Hammound Hospital University Medical Center

location_facility: UMHAT Sveti Georgi 3rd Clinical of Surgery

location_facility: Multiprofile Hospital for Active Trt Emergency Med

location_facility: Amrita Institute of Medical Sciences, Cochin

location_facility: UMHAT Queen Joanna-ISUL, Clinical of Surgery


ReferenceCitation: Henigsberg N, Mahableshwarkar AR, Jacobsen P, Chen Y, Thase ME. A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with major depressive disorder. J Clin Psychiatry. 2012 Jul;73(7):953-9. doi: 10.4088/JCP.11m07470.

ReferenceCitation: McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jan;78(1):115-121. doi: 10.4088/JCP.16m10744.

family: McIntyre

full_name: Roger S. McIntyre

given: Roger S.

family: Florea

full_name: Ioana Florea

given: Ioana

family: Tonnoir

full_name: Brigitte Tonnoir

given: Brigitte

family: Loft

full_name: Henrik Loft

given: Henrik

family: Lam

full_name: Raymond W. Lam

given: Raymond W.

family: Christensen

full_name: Michael Cronquist Christensen

given: Michael Cronquist

bso_classification: Social sciences

journal_name: The Journal of Clinical Psychiatry

publisher: Physicians Postgraduate Press, Inc

publisher_dissemination: Physicians Postgraduate Press, Inc

publisher_group: Physicians Postgraduate Press, Inc

publisher_normalized: Physicians Postgraduate Press, Inc

lead_sponsor: Takeda

location_country:
South Africa
United Kingdom
Netherlands
France
Malaysia
Lithuania
Poland
Latvia
Australia
Russian Federation
Germany
Czech Republic
Korea, Republic of
Taiwan
Ukraine

type: Registry Identifier

title: A Randomized, Double-blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder

summary: The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients with Major Depressive Disorder.


lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Finland
Malaysia
Romania
Australia
Belgium
Russian Federation
Taiwan
India
Croatia
France
Poland
Slovakia
Thailand
Norway
Argentina
Korea, Republic of
South Africa
Chile
Philippines
Bulgaria
Hungary
Puerto Rico
United States
Austria
Serbia
Mexico
Spain
Estonia

acronym: ASPIRE

title: A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia

summary: To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.


title: A Multicenter, Double-blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy.

summary: The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.

location_country:
United States
France
Poland
Hungary
Germany

location_facility: SZPZOZ Szpital Zachodni im. Jana Pawla II

location_facility: Samodzielny Publiczny Szpital Kliniczny NR 1 im. Prof. Stanislawa Szysko SAM

location_facility: Zespół Opieki Zdrowotnej w Łęczycy, Poradnia Diabetologiczna Łeczyca

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Poradnia Diabetologiczna, Zespol Opieki Zdrowotnej w Leczycy

location_facility: Szspital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Ponza

location_facility: NZOZ Specjalistyczny Ośrodek Internistyczno - Diabetologiczny Białystok

location_facility: NZCZ Regionalna Poradnia Diabetologiczna


title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of Oral Cladribine in Subjects With a First Clinical Event at High Risk of Converting to MS

acronym: ORACLE MS

summary: A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome). Participants in either the cladribine or placebo group may also enter treatment periods with open-label interferon-beta or open-label cladribine depending upon the disease status. The primary objective of this study is to evaluate the effect of two dosage regimens of oral cladribine versus placebo on the time to conversion to multiple sclerosis (MS) (from randomization) according to the Poser criteria in participants with first clinical demyelinating event at high risk of converting to MS.

ReferenceCitation: Giovannoni G, Galazka A, Schick R, Leist T, Comi G, Montalban X, Damian D, Dangond F, Cook S. Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety. Drug Saf. 2020 Jul;43(7):635-643. doi: 10.1007/s40264-020-00948-x.

family: Giovannoni

full_name: Gavin Giovannoni

given: Gavin

family: Galazka

full_name: Andrew Galazka

given: Andrew

family: Schick

full_name: Regina Schick

given: Regina

family: Leist

full_name: Thomas Leist

given: Thomas

family: Comi

full_name: Giancarlo Comi

given: Giancarlo

family: Montalban

full_name: Xavier Montalban

given: Xavier

family: Damian

full_name: Doris Damian

given: Doris

family: Dangond

full_name: Fernando Dangond

given: Fernando

family: Cook

full_name: Stuart Cook

given: Stuart

journal_name: Drug Safety

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Freedman MS, Leist TP, Comi G, Cree BA, Coyle PK, Hartung HP, Vermersch P, Damian D, Dangond F. The efficacy of cladribine tablets in CIS patients retrospectively assigned the diagnosis of MS using modern criteria: Results from the ORACLE-MS study. Mult Scler J Exp Transl Clin. 2017 Oct 9;3(4):2055217317732802. doi: 10.1177/2055217317732802. eCollection 2017 Oct-Dec.

name: Department of Medicine (Neurology), University of Ottawa and the Ottawa Hospital Research Institute, Canada

family: Freedman

full_name: Mark S Freedman

given: Mark S

name: Division of Clinical Neuroimmunology, Thomas Jefferson University, USA

full_name: Thomas P Leist

given: Thomas P

name: Department of Neurology and Institute of Experimental Neurology, Università Vita-Salute San Raffaele, Ospedale San Raffaele, Italy

name: University of California San Francisco, USA

family: Cree

full_name: Bruce AC Cree

given: Bruce AC

name: Stony Brook University, Department of Neurology, USA

family: Coyle

full_name: Patricia K Coyle

given: Patricia K

name: Department of Neurology, Heinrich Heine University, Medical Faculty, Germany

family: Hartung

full_name: Hans-Peter Hartung

given: Hans-Peter

name: University of Lille, CHU Lille, LIRIC-INSERM U995, FHU Imminent, France

family: Vermersch

full_name: Patrick Vermersch

name: EMD Serono Inc, EMD Serono Inc, Billerica, USA

journal_name: Multiple Sclerosis Journal - Experimental, Translational and Clinical

repository_institution: California Digital Library - eScholarship

repository_normalized: California Digital Library - eScholarship

repositories: California Digital Library - eScholarship

repositories_institution: California Digital Library - eScholarship

ReferenceCitation: Leist TP, Comi G, Cree BA, Coyle PK, Freedman MS, Hartung HP, Vermersch P, Casset-Semanaz F, Scaramozza M; oral cladribine for early MS (ORACLE MS) Study Group. Effect of oral cladribine on time to conversion to clinically definite multiple sclerosis in patients with a first demyelinating event (ORACLE MS): a phase 3 randomised trial. Lancet Neurol. 2014 Mar;13(3):257-67. doi: 10.1016/S1474-4422(14)70005-5. Epub 2014 Feb 4.

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
North Macedonia
Finland
Romania
Belgium
Russian Federation
Taiwan
Ukraine
India
Croatia
France
Poland
Thailand
Norway
Argentina
Canada
Korea, Republic of
Turkey
Sweden
United Arab Emirates
Bulgaria
Singapore
Portugal
Germany
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Serbia
Lebanon
Czechia
Georgia
Spain
Estonia

location_facility: Institue for Clinical Radiology of the State Establishment "Research Centre for Radiation Medicine of the AMS of Ukraino" Depart of Radiation Psychoneurology

location_facility: S. Khechinashvili Tbilisi State Medical University

location_facility: State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1"

location_facility: Federal State Institution " Siberian Reginal Medical Center of Roszdarv"

location_facility: Non-State Healthcare Institution "Central Clinical Hospital #2 named after N.A. Semasko of Russian Railways"

location_facility: Vladimir Regional State Healthcare Institution "Regional Clinical Hospital"

location_facility: Regional State Healthcare Institution "State Smolensk Region Clinical Hospital"

location_facility: Vinnylsia Regional Psychoneurological Hosptial Named After O. I Yushchenko, Neurological Depart, Vinnytsia National Medical University Named After M. I. Pirogov, Chair of Neurology

location_facility: Hope Research Institute Medical Plaza LLC Desert Hills

location_facility: Hospital Universitario Nuestra Senora de la Candelaria

location_facility: Fakultní nemocnice s poliklinikou Ostrava

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: State institution Science Research Institute Clinical and Experimental Lymphology of Russian Academy of Medical Sciences

location_facility: Department of Neurology, 50 Ilwon-dong, Gangnam-gu

location_facility: MS Center of Brevard MIMA Centry Research Associates

location_facility: Turun Yliopistollinen Keskussairaala Rakennus 3 1

location_facility: Amrita Institute of Medical Sciences and Research

location_facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences

location_facility: Villa Sofia Hospital Azienda Ospedaliera Villa Sofia P.zza Salerno e Resuttana 1

location_facility: State Medical Institution "Republican Rehabilitation Clinic of Tatarstan Ministry of Health"

location_facility: Azienda Sanitaria Ospedaliera San Luigi Gonzaga

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika

location_facility: International Clinic and Hospital, Neurology

location_facility: CHU de Liege - Domaine Universitaire du Sart Tilman,

location_facility: University of Colorado at Denver Health Sciences

location_facility: Moscow State Healthcare Institution City Clinical Hospital #11

location_facility: State Educational Institution of Higher Professional Education "Saratov State Medical University of Roszdrav" based on Clincial Hosptial #3 of Saratov State Medical University

location_facility: State Educational Institution of Higher Professional Education "Military Medical Academy named after S. M. Korov of Dept of Defense of Russian Federation based on Clinic of Neurology of State Institution

location_facility: Institute of Human Brain of Russian Academy of Science Dept. of Multiple Sclerosis

location_facility: National Neuroscience Institute (TTSH Campus)

location_facility: "Dr. Carol Davilla" Military Clinical Hospital

location_facility: State Educational Institute of Higher Professional Education "I.M. Sechenov Moscow Medical Academy of Roszdrav" Russia based on A. Ya. Kozhevnikov Nervous Disease Clinic

location_facility: Wojewodzki Szpital Specjalistyczny Oddział Neurologii z Pododdziałem Udarowym

location_facility: State Educational Institution of Higher Professional Education "Siberian State Medical University of Roszdrav"

location_facility: Regionsykehuset I Trondheim, Nevrologisk avd.

location_facility: Municipal Treatment Prophylactic Institution "City Hospital #33"

location_facility: Municipal Healthcare Institution "Yaroslavi Clinical Hospital #8"

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: St. Petersburg State Healthcare Institution "Multifield City Hospital #2"

location_facility: Comprehensive MS Care Clinic at South Shore Multiple Sclerosis

location_facility: Multiple Sclerosis Center of Northeastern NY

location_facility: Chang Gung Medical Foundation- Linkou Branch No5

location_facility: Neurologian Klinikka Seinajoen Keskussairaala

location_facility: Azienda Ospedaliera S. Camillo Forlanini

location_facility: Municipal Healthcare Institution "City Clinical Hospital #3"

location_facility: State Healthcare Institution "Rostov Region Clinical Hospital"

location_facility: Neurology & Neurological Association of Tacoma

location_facility: Multiple Sclerosis Center Drive, Neurology Suite 701

location_facility: Closed joint-stock society Medical sanitary unit "Nephtaynik" based the hospital

location_facility: State Healthcare Institution "Kemerovo Regional Clinical Hospital"

location_facility: State Healthcare Institution "Kaluga Regional Hospital"

location_facility: Hospital for Prevention and Treatment of Cerebro-Vascular Diseases

location_facility: University of Medicine and Dentistry of New Jersey School of Neurology

location_facility: Helse Bergen HF Kvinneklinikken Haukeland Universitetssykehus Jonas

location_facility: State Educational Institute of Higher Professional Education "Rostov State Medical University of Roszdrav"

location_facility: Seoul National University Hospital, Department of Neurology

location_facility: Department of Neurology, Asan Medical Center, 388-1 Pungnap 2-dong, Songpa-gu

location_facility: Universitaetsklinikum und Medizinische Fakultaet Heidelberg

location_facility: State Educational Institution of Higher Professional Education "Samara State Medical University of Roszdrav" on State Healthcare Institution "Samara Regional Clinical Hospital named after M. I. Kalinin"

location_facility: Ospedale Binaghi Centro Sclerosi Multipla

location_facility: National Cancer Center, Department of Neurology,

location_facility: State Medical Institution " Jursk Regional Clinical Hospital"

location_facility: State Established "Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine", Depart of Neurinfections and Multiple Sclorosis

location_facility: Yonsei University Medical Center, Department of Neurology, Yonsei University Medical Center


title: A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-small Cell Lung Cancer

summary: The purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.

ReferenceCitation: Edelman MJ, Schneider CP, Tsai CM, Kim HT, Quoix E, Luft AV, Kaleta R, Mukhopadhyay P, Trifan OC, Whitaker L, Reck M. Randomized phase II study of ixabepilone or paclitaxel plus carboplatin in patients with non-small-cell lung cancer prospectively stratified by beta-3 tubulin status. J Clin Oncol. 2013 Jun 1;31(16):1990-6. doi: 10.1200/JCO.2012.45.3282. Epub 2013 Apr 15.

name: Martin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Claus-Peter Schneider, Zentralklinik Bad Berka, Bad Berka; Martin Reck, Hospital Grosshansdorf, Grosshansdorf, Germany; Chun-Ming Tsai, Taipei Veterans General Hospital, Taipei, Taiwan; Heung-Tae Kim, National Cancer Center, Goyang-Si, Korea; Elisabeth Quoix, Nouvel Hopital Civil, Strasbourg, France; Alexander V. Luft, Leningrad Regional Clinical Hospital, St Petersburg, Russia; and Remigiusz Kaleta, Pralay Mukhopadhyay,...

family: Edelman

full_name: Martin J. Edelman

given: Martin J.

family: Schneider

full_name: Claus-Peter Schneider

given: Claus-Peter

family: Tsai

full_name: Chun-Ming Tsai

given: Chun-Ming

family: Kim

full_name: Heung-Tae Kim

given: Heung-Tae

family: Quoix

full_name: Elisabeth Quoix

given: Elisabeth

family: Luft

full_name: Alexander V. Luft

given: Alexander V.

family: Kaleta

full_name: Remigiusz Kaleta

given: Remigiusz

family: Mukhopadhyay

full_name: Pralay Mukhopadhyay

given: Pralay

family: Trifan

full_name: Ovidiu C. Trifan

given: Ovidiu C.

family: Whitaker

full_name: Laura Whitaker

given: Laura

family: Reck

full_name: Martin Reck

given: Martin

publisher_group: American Society of Clinical Oncology (ASCO)

title: Randomized Phase II Study of Ixabepilone or Paclitaxel Plus Carboplatin in Patients With Non–Small-Cell Lung Cancer Prospectively Stratified by Beta-3 Tubulin Status

lead_sponsor: R-Pharm

location_country:
Italy
United States
France
Argentina
Australia
Russian Federation
Spain
Germany
Korea, Republic of
Taiwan

location_facility:
Uof Md,Greenebaum Cancer Ctr.
Local Institution
Scripps Cancer Center


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

location_country:
Italy
South Africa
India
Serbia
United Kingdom
Spain
Philippines
Germany
France
Czechia
Poland
Slovakia
Romania
Belgium
Russian Federation
Portugal
United States
Slovenia
Colombia
Ukraine

title: A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study Evaluating The Efficacy And Safety Of Latanoprost And Timolol In Pediatric Subjects With Glaucoma.

summary: To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.


title: A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate Efficacy and Safety of Prolonged Release (PR) OROS Methylphenidate (54 and 72 mg/Day) in Adults With Attention Deficit/Hyperactivity Disorder

summary: The purpose of this study is to evaluate the efficacy of 2 fixed dosages of Prolonged Release (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult patients with attention deficit/hyperactivity disorder (ADHD).

lead_sponsor: Janssen-Cilag International NV

location_country:
Sweden
Switzerland
Netherlands
Finland
France
Norway
Belgium
Spain
Denmark
Germany
United Kingdom


ReferenceCitation: Inbal A, Oldenburg J, Carcao M, Rosholm A, Tehranchi R, Nugent D. Recombinant factor XIII: a safe and novel treatment for congenital factor XIII deficiency. Blood. 2012 May 31;119(22):5111-7. doi: 10.1182/blood-2011-10-386045. Epub 2012 Mar 26.

name: Thrombosis and Hemostasis Unit, Rabin Medical Center, Petah Tikva and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel;

family: Inbal

full_name: Aida Inbal

given: Aida

name: Institute of Experimental Haematology and Transfusion Medicine, University Clinic, Bonn, Germany;

family: Oldenburg

full_name: Johannes Oldenburg

given: Johannes

name: Haematology/Oncology, Hospital for Sick Children, Toronto, ON;

family: Carcao

full_name: Manuel Carcao

given: Manuel

name: Biostatistics, Novo Nordisk A/S, Copenhagen, Denmark;

family: Rosholm

full_name: Anders Rosholm

given: Anders

name: Medical and Science, Haemostasis R&D Portfolio, Novo Nordisk A/S, Copenhagen, Denmark;

family: Tehranchi

full_name: Ramin Tehranchi

given: Ramin

name: Department of Hematology, Children's Hospital of Orange County/University of California, Irvine Medical School, Orange, CA

family: Nugent

full_name: Diane Nugent

given: Diane

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

ReferenceCitation: Brand-Staufer B, Carcao M, Kerlin BA, Will A, Williams M, Tornøe CW, Sandberg Lundblad M, Nugent D. Pharmacokinetic characterization of recombinant factor XIII (FXIII)-A2 across age groups in patients with FXIII A-subunit congenital deficiency. Haemophilia. 2015 May;21(3):380-5. doi: 10.1111/hae.12616. Epub 2015 Jan 21.

name: Division of Haematology; University Hospital Zurich; Zurich Switzerland

family: Brand-Staufer

full_name: B. Brand-Staufer

given: B.

name: Division of Haematology/Oncology and Child Health Evaluative Sciences; Department of Paediatrics; Research Institute; Hospital for Sick Children; Toronto ON Canada

full_name: M. Carcao

given: M.

name: Nationwide Children's Hospital; Columbus OH USA

family: Kerlin

full_name: B. A. Kerlin

given: B. A.

name: Royal Manchester Children's Hospital; Manchester UK

family: Will

full_name: A. Will

given: A.

name: Birmingham Children's Hospital; Birmingham UK

family: Williams

full_name: M. Williams

name: Clinical Pharmacology; Novo Nordisk A/S; Søborg Denmark

family: Tornøe

full_name: C. W. Tornøe

given: C. W.

family: Sandberg Lundblad

full_name: M. Sandberg Lundblad

name: Children's Hospital of Orange County; Children's Hospital and Center for Inherited Blood Disorders; Orange CA USA

full_name: D. Nugent

given: D.

journal_name: Haemophilia

lead_sponsor: Novo Nordisk A/S

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

title: A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Subjects With Congenital Factor XIII Deficiency

summary: The trial is conducted in Europe, North America and Asia. The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of bleeding episodes.


location_country:
United States
South Africa
Serbia
United Kingdom
Netherlands
Croatia
France
Lithuania
Malaysia
Poland
Australia
Russian Federation
Germany
Latvia
Korea, Republic of
Taiwan
Ukraine

title: A Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 in Subjects With Major Depressive Disorder

summary: The purpose of this study is to determine the long-term efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.


title: A Phase III Open-label Titration Trial to Evaluate the Effectiveness and Safety of Different Doses of a Dermal Application of Testosterone MD-Lotion® (Cutaneous Solution) in Hypogonadal Men

summary: Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product- Testosterone MD-Lotion (cutaneous solution), and this study will evaluate the efficacy via pharmacokinetics of various doses of this product. The study will also assess safety of the product.

ReferenceCitation: Wang C, Ilani N, Arver S, McLachlan RI, Soulis T, Watkinson A. Efficacy and safety of the 2% formulation of testosterone topical solution applied to the axillae in androgen-deficient men. Clin Endocrinol (Oxf). 2011 Dec;75(6):836-43. doi: 10.1111/j.1365-2265.2011.04152.x.

family: Wang

full_name: Christina Wang

given: Christina

family: Ilani

full_name: Niloufar Ilani

given: Niloufar

family: Arver

full_name: Stefan Arver

given: Stefan

family: McLachlan

full_name: Robert I. McLachlan

given: Robert I.

family: Soulis

full_name: Tina Soulis

given: Tina

family: Watkinson

full_name: Adam Watkinson

given: Adam

journal_name: Clinical Endocrinology

ReferenceCitation: Muram D, Ni X. Utility of a single serum testosterone measurement to determine response to topical testosterone replacement in hypogonadal men. Curr Med Res Opin. 2016;32(2):263-9. doi: 10.1185/03007995.2015.1117434. Epub 2015 Dec 15.

family: Muram

full_name: David Muram

given: David

family: Ni

full_name: Xiao Ni

given: Xiao

journal_name: Current Medical Research and Opinion

publisher: Informa Healthcare

lead_sponsor: Eli Lilly and Company

location_country:
United States
Sweden
France
Australia
Germany
United Kingdom

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


ReferenceCitation: Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fosså SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzén L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland ØS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. doi: 10.1056/NEJMoa1213755.

family: Parker

full_name: C. Parker

given: C.

family: Nilsson

full_name: S. Nilsson

given: S.

family: Heinrich

full_name: D. Heinrich

family: Helle

full_name: S.I. Helle

family: O'Sullivan

full_name: J.M. O'Sullivan

family: Fosså

full_name: S.D. Fosså

family: Chodacki

full_name: A. Chodacki

family: Wiechno

full_name: P. Wiechno

given: P.

family: Logue

full_name: J. Logue

given: J.

family: Seke

full_name: M. Seke

family: Widmark

full_name: A. Widmark

family: Johannessen

full_name: D.C. Johannessen

family: Hoskin

full_name: P. Hoskin

family: Bottomley

full_name: D. Bottomley

family: James

full_name: N.D. James

family: Solberg

full_name: A. Solberg

family: Syndikus

full_name: I. Syndikus

given: I.

family: Kliment

full_name: J. Kliment

family: Wedel

full_name: S. Wedel

family: Boehmer

full_name: S. Boehmer

family: Dall'Oglio

full_name: M. Dall'Oglio

family: Franzén

full_name: L. Franzén

given: L.

family: Coleman

full_name: R. Coleman

given: R.

family: Vogelzang

full_name: N.J. Vogelzang

family: O'Bryan-Tear

full_name: C.G. O'Bryan-Tear

family: Staudacher

full_name: K. Staudacher

given: K.

family: Garcia-Vargas

full_name: J. Garcia-Vargas

title: Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer

ReferenceCitation: Hoskin P, Sartor O, O'Sullivan JM, Johannessen DC, Helle SI, Logue J, Bottomley D, Nilsson S, Vogelzang NJ, Fang F, Wahba M, Aksnes AK, Parker C. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. Lancet Oncol. 2014 Nov;15(12):1397-406. doi: 10.1016/S1470-2045(14)70474-7. Epub 2014 Oct 17.

ReferenceCitation: Sartor O, Coleman R, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fosså SD, Chodacki A, Wiechno P, Logue J, Widmark A, Johannessen DC, Hoskin P, James ND, Solberg A, Syndikus I, Vogelzang NJ, O'Bryan-Tear CG, Shan M, Bruland ØS, Parker C. Effect of radium-223 dichloride on symptomatic skeletal events in patients with castration-resistant prostate cancer and bone metastases: results from a phase 3, double-blind, randomised trial. Lancet Oncol. 2014 Jun;15(7):738-46. doi: 10.1016/S1470-2045(14)70183-4. Epub 2014 May 13.

ReferenceCitation: Delacruz A, Arauz G, Curley T, Lindo A, Jensen T. Nursing management of patients with castration-resistant prostate cancer undergoing radium-223 dichloride treatment. Clin J Oncol Nurs. 2015 Apr;19(2):E31-5. doi: 10.1188/15.CJON.E31-E35.

title: Nursing Management of Patients With Castration-Resistant Prostate Cancer Undergoing Radium-223 Dichloride Treatment

ReferenceCitation: Humm JL, Sartor O, Parker C, Bruland OS, Macklis R. Radium-223 in the treatment of osteoblastic metastases: a critical clinical review. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):898-906. doi: 10.1016/j.ijrobp.2014.12.061. Review.

journal_name: International Journal of Radiation Oncology*Biology*Physics

title: Radium-223 in the Treatment of Osteoblastic Metastases: A Critical Clinical Review

ReferenceCitation: Nilsson S. Alpha-emitter radium-223 in the management of solid tumors: current status and future directions. Am Soc Clin Oncol Educ Book. 2014:e132-9. doi: 10.14694/EdBook_AM.2014.34.e132. Review.

name: From the Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden.

journal_name: American Society of Clinical Oncology Educational Book

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Alpha-Emitter Radium-223 in the Management of Solid Tumors: Current Status and Future Directions

ReferenceCitation: Den RB, Doyle LA, Knudsen KE. Practical guide to the use of radium 223 dichloride. Can J Urol. 2014 Apr;21(2 Supp 1):70-6. Review.

ReferenceCitation: Shirley M, McCormack PL. Radium-223 dichloride: a review of its use in patients with castration-resistant prostate cancer with symptomatic bone metastases. Drugs. 2014 Apr;74(5):579-86. doi: 10.1007/s40265-014-0198-4. Review.

title: Radium-223 Dichloride: A Review of Its Use in Patients with Castration-Resistant Prostate Cancer with Symptomatic Bone Metastases

ReferenceCitation: Wissing MD, van Leeuwen FW, van der Pluijm G, Gelderblom H. Radium-223 chloride: Extending life in prostate cancer patients by treating bone metastases. Clin Cancer Res. 2013 Nov 1;19(21):5822-7. doi: 10.1158/1078-0432.CCR-13-1896. Epub 2013 Sep 19. Review.

publisher: American Association for Cancer Research (AACR)

title: Radium-223 Chloride: Extending Life in Prostate Cancer Patients by Treating Bone Metastases

ReferenceCitation: Joung JY, Ha YS, Kim IY. Radium Ra 223 dichloride in castration-resistant prostate cancer. Drugs Today (Barc). 2013 Aug;49(8):483-90. doi: 10.1358/dot.2013.49.8.1968670.

ReferenceCitation: Parker C, Zhan L, Cislo P, Reuning-Scherer J, Vogelzang NJ, Nilsson S, Sartor O, O'Sullivan JM, Coleman RE. Effect of radium-223 dichloride (Ra-223) on hospitalisation: An analysis from the phase 3 randomised Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) trial. Eur J Cancer. 2017 Jan;71:1-6. doi: 10.1016/j.ejca.2016.10.020. Epub 2016 Dec 6.

repository_institution: Queen's University Belfast - Research Portal

location_country:
Italy
United States
Brazil
Sweden
Hong Kong
Netherlands
United Kingdom
Germany
France
Poland
Israel
Slovakia
Norway
Singapore
Belgium
Australia
Spain
Canada
Czech Republic

title: A Double-blind, Randomised, Multiple Dose, Phase III, Multicentre Study of Alpharadin in the Treatment of Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases

summary: ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases.


title: A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of Talampanel in Subjects With Amyotrophic Lateral Sclerosis (ALS)

acronym: ALS

summary: The purpose of this study is to assess the efficacy, tolerability and safety of oral administration of talampanel compared to a placebo in subjects with ALS.

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

location_country:
Italy
United States
Netherlands
Germany
France
Israel
Hungary
Belgium
Spain
Canada

location_facility: Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze

location_facility: Massachusetts General Hospital-Neurology Clinical Trials Unit

location_facility: University of Kansas Medical Center - Dept of Neurology

location_facility: Semmelweis University, Department of Neurology

location_facility: Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik

location_facility: CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center

location_facility: Hopital La Pitie Salpetriere - Federation de Neurologie

location_facility: C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques

location_facility: Columbia University - Neurology Institute

location_facility: Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik

location_facility: Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone

location_facility: C.H.U. La Timone - Service de Neurologie

location_facility: Academic Hospital University of Leuven - ALS dept

location_facility: London Health Sciences Centre Motor Neuro Diseases Clinic

intervention_type: Other