ReferenceCitation: Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchère D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7.

family: Asmane

full_name: Irène Asmane

given: Irène

family: Watkin

full_name: Emmanuel Watkin

given: Emmanuel

family: Alberti

full_name: Laurent Alberti

given: Laurent

family: Duc

full_name: Adeline Duc

given: Adeline

family: Marec-Berard

full_name: Perrine Marec-Berard

given: Perrine

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Cassier

full_name: Philippe Cassier

given: Philippe

family: Decouvelaere

full_name: Anne-Valérie Decouvelaere

given: Anne-Valérie

family: Ranchère

full_name: Dominique Ranchère

given: Dominique

family: Kurtz

full_name: Jean-Emmanuel Kurtz

given: Jean-Emmanuel

family: Bergerat

full_name: Jean-Pierre Bergerat

given: Jean-Pierre

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

title: Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: A predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas

ReferenceCitation: Pappo AS, Patel SR, Crowley J, Reinke DK, Kuenkele KP, Chawla SP, Toner GC, Maki RG, Meyers PA, Chugh R, Ganjoo KN, Schuetze SM, Juergens H, Leahy MG, Geoerger B, Benjamin RS, Helman LJ, Baker LH. R1507, a monoclonal antibody to the insulin-like growth factor 1 receptor, in patients with recurrent or refractory Ewing sarcoma family of tumors: results of a phase II Sarcoma Alliance for Research through Collaboration study. J Clin Oncol. 2011 Dec 1;29(34):4541-7. doi: 10.1200/JCO.2010.34.0000. Epub 2011 Oct 24.

name: Alberto S. Pappo, St Jude Children's Research Hospital, Memphis, TN; Shreyaskumar R. Patel and Robert S. Benjamin, MD Anderson Cancer Center, Houston, TX; John Crowley, Cancer Research and Biostatistics, Seattle, WA; Denise K. Reinke, Sarcoma Alliance for Research through Collaboration; Rashmi Chugh, Scott M. Schuetze, and Laurence H. Baker, University of Michigan, Ann Arbor, MI; Klaus-Peter Kuenkele, Roche, Penzberg; Heribert Juergens, University Children's Hospital, Muenster, Germany; Sant P. Chawla,...

family: Pappo

full_name: Alberto S. Pappo

given: Alberto S.

family: Patel

full_name: Shreyaskumar R. Patel

given: Shreyaskumar R.

family: Crowley

full_name: John Crowley

given: John

family: Reinke

full_name: Denise K. Reinke

given: Denise K.

family: Kuenkele

full_name: Klaus-Peter Kuenkele

given: Klaus-Peter

family: Chawla

full_name: Sant P. Chawla

given: Sant P.

family: Toner

full_name: Guy C. Toner

given: Guy C.

family: Maki

full_name: Robert G. Maki

given: Robert G.

family: Meyers

full_name: Paul A. Meyers

given: Paul A.

family: Chugh

full_name: Rashmi Chugh

given: Rashmi

family: Ganjoo

publisher_group: American Society of Clinical Oncology (ASCO)

title: R1507, a Monoclonal Antibody to the Insulin-Like Growth Factor 1 Receptor, in Patients With Recurrent or Refractory Ewing Sarcoma Family of Tumors: Results of a Phase II Sarcoma Alliance for Research Through Collaboration Study

location_country:
Italy
United States
Sweden
Netherlands
Germany
France
Norway
Australia
Spain
Canada
United Kingdom

location_facility: Washington Cancer Institute; Washington Hospital Center

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Massachusetts General Hospital; Dana Farber Partnes Cancer Center

location_facility: Texas Children's Cancer Center; Baylor College of Medicine

location_facility: Nebraska Methodist Hospital; Onc Hem West

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Oregon Health and Science University Cancer Institute

location_facility: Huntsman Cancer Institute; Orthopedic Center

location_facility: Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Albert Einstein College of Medical Pediatrics; Department of Pediatrics

location_facility: Institut Gustave Roussy; Service Pediatrique

location_facility: University of Texas M.D. Anderson Cancer Center

location_facility: UCLA School Of Medicine Mattel's Children's Hospital At UCLA; Division Of Hematology-Oncology

location_facility: Carolinas Hematology Oncology Associates; Investigational Drug Services - Pharmacy

location_facility: Uniklinik Mannheim; Sektion Chirurgische Onkologie & Thoraxchirurgie

location_facility: HELIOS Klinikum Bad Saarow; Klinik für Innere Medizin III

location_facility: Centre Oscar Lambret; Chir Cancerologie General

location_facility: Peter Maccallum Cancer Institute; Medical Oncology

title: A Phase II Trial of R1507, a Recombinant Human Monoclonal Antibody to the Insulin-Like Growth Factor-1 Receptor for the Treatment of Participants With Recurrent or Refractory Ewing's Sarcoma, Osteosarcoma, Synovial Sarcoma, Rhabdomyosarcoma and Other Sarcomas.

summary: The study was primarily designed to determine objective response, progression-free survival (PFS), and the safety and tolerability of R1507 in participants with recurrent or refractory Ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma and other sarcomas including alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma, and myxoid liposarcoma.


title: Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea

summary: The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Diamant M, Van Gaal L, Stranks S, Guerci B, MacConell L, Haber H, Scism-Bacon J, Trautmann M. Safety and efficacy of once-weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes over 84 weeks. Diabetes Care. 2012 Apr;35(4):683-9. doi: 10.2337/dc11-1233. Epub 2012 Feb 22.

family: Diamant

full_name: M. Diamant

given: M.

sequence: first

family: Van Gaal

full_name: L. Van Gaal

given: L.

sequence: additional

family: Stranks

full_name: S. Stranks

given: S.

family: Guerci

full_name: B. Guerci

given: B.

family: MacConell

full_name: L. MacConell

family: Haber

full_name: H. Haber

given: H.

family: Scism-Bacon

full_name: J. Scism-Bacon

given: J.

family: Trautmann

full_name: M. Trautmann

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Diabetes Care

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Safety and Efficacy of Once-Weekly Exenatide Compared With Insulin Glargine Titrated to Target in Patients With Type 2 Diabetes Over 84 Weeks

ReferenceType: derived

ReferenceCitation: Guja C, Frías JP, Suchower L, Hardy E, Marr G, Sjöström CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18. Erratum in: Diabetes Ther. 2020 Dec;11(12):3011-3013.

family: Guja

full_name: Cristian Guja

given: Cristian

family: Frías

full_name: Juan P. Frías

given: Juan P.

family: Suchower

full_name: Lisa Suchower

given: Lisa

family: Hardy

full_name: Elise Hardy

given: Elise

family: Marr

full_name: Galina Marr

given: Galina

family: Sjöström

full_name: C. David Sjöström

given: C. David

family: Jabbour

full_name: Serge A. Jabbour

given: Serge A.

ReferenceCitation: Diamant M, Van Gaal L, Guerci B, Stranks S, Han J, Malloy J, Boardman MK, Trautmann ME. Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial. Lancet Diabetes Endocrinol. 2014 Jun;2(6):464-73. doi: 10.1016/S2213-8587(14)70029-4. Epub 2014 Apr 4. Erratum in: Lancet Diabetes Endocrinol. 2014 Jun;2(6):e13.

ReferenceCitation: Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.

title: Efficacy, Safety, and Tolerability of Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus: An Integrated Analysis of the DURATION Trials

ReferenceCitation: Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48.

ReferenceCitation: Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.

ReferenceCitation: Diamant M, Van Gaal L, Stranks S, Northrup J, Cao D, Taylor K, Trautmann M. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet. 2010 Jun 26;375(9733):2234-43. doi: 10.1016/S0140-6736(10)60406-0.

location_country:
Mexico
Netherlands
Germany
Spain
France
Greece
Hungary
Belgium
Australia
Puerto Rico
Russian Federation
Denmark
United States
Czech Republic
Korea, Republic of
Taiwan


title: A Phase III, Double-blind, Placebo-controlled, Randomised Trial to Determine the Efficacy and Safety of a Dose Range of 50 to 100 mg/Day of Safinamide, as add-on Therapy, in Subjects With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, an Anticholinergic and/or Amantadine

acronym: SETTLE

summary:
Parkinson's Disease is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO-B, the major DA metabolising enzyme in man.

Safinamide is an inhibitor of MAO-B. This is a phase III trial to evaluate the efficacy and safety of safinamide (50 and 100 mg p.o. q.a.m.) compared to placebo as add-on therapy to a stable dose to levodopa in subjects with advance idiopathic Parkinson's Disease.

The principal efficacy measure is the increase in mean daily "on" time during the 18-hr diary recording period.

ReferenceCitation: Schapira AH, Fox SH, Hauser RA, Jankovic J, Jost WH, Kenney C, Kulisevsky J, Pahwa R, Poewe W, Anand R. Assessment of Safety and Efficacy of Safinamide as a Levodopa Adjunct in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial. JAMA Neurol. 2017 Feb 1;74(2):216-224. doi: 10.1001/jamaneurol.2016.4467.

name: Department of Clinical Neurosciences, University College London Institute of Neurology, London, United Kingdom

family: Schapira

full_name: Anthony H. V. Schapira

given: Anthony H. V.

name: Department of Medicine, Division of Neurology, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada

family: Fox

full_name: Susan H. Fox

given: Susan H.

name: Department of Neurology, University of South Florida College of Medicine, Tampa

family: Hauser

full_name: Robert A. Hauser

given: Robert A.

name: Department of Neurology, Baylor College of Medicine, Houston, Texas

family: Jankovic

full_name: Joseph Jankovic

given: Joseph

family: Jost

full_name: Wolfgang H. Jost

given: Wolfgang H.

name: Biotie Therapies Inc, San Francisco, California

family: Kenney

full_name: Christopher Kenney

given: Christopher

name: Servicio de Neurología, Sant Pau Hospital, Universidad Autonoma de Barcelona, Universitat Oberta de Catalunya, Barcelona, Spain

family: Kulisevsky

full_name: Jaime Kulisevsky

given: Jaime

name: Department of Neurology, University of Kansas Medical Center, Kansas City

family: Pahwa

full_name: Rajesh Pahwa

given: Rajesh

name: Department of Neurology, Medical University Innsbruck, Innsbruck, Austria

family: Poewe

full_name: Werner Poewe

given: Werner

family: Anand

full_name: Ravi Anand

given: Ravi

journal_name: JAMA Neurology

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

lead_sponsor: Newron Pharmaceuticals SPA

location_country:
Malaysia
Australia
Belgium
Taiwan
India
France
Thailand
Slovakia
Canada
Korea, Republic of
Switzerland
Netherlands
Hungary
United States
Germany
United Kingdom
Austria
Israel
New Zealand
Spain
Estonia

location_facility: University Of South Florida Medical Center

location_facility: Nestatne zdravotnicke zariadenie Neurologicka ambulancia

location_facility: Clinexpert Kereskedelmi es Szolgaltato Kft.

location_facility: Parkinson's and Neurodegenerative Disorders Clinic

location_facility: Van der Veer Institute for Parkinson's & Brain Research

location_facility: Severance Hospital, Yonsei University College of Medicine

location_facility: Charité Campus Virchow Universitaetsmedizin Berlin

location_facility: Northwestern University PD and Movement Disorders Center

location_facility: Institute for Neurodegenerative Disorders

location_facility: BAZ Country Hospital and Outpatient Clinic Dept. of Neurology Toxicology and Stroke

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: University Health Network -Toronto Western Hosp.

location_facility: Fakultna nemocnica Trnava Interna klinika

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Parkinson's Disease Treatment Center of SW Florida

location_facility: Fővárosi Önkormányzat Nyírő Gyula Kórhaz Neurologiai Osztály

location_facility: MU Dr.Beata Dupejová neurologicka ambulancia s.r.o

location_facility: Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.

location_facility: Parkinson's Disease and Movement Disorder Center

location_facility: M. S. Ramaiah Medical College and Hospital

location_facility: All India Institute of Medical Sciences (AIIMS)

location_facility: CHU Nantes Hôpital Laennec - CIC Neurologie

location_facility: Vseobecna nemocnica s poliklinikou Levoca

location_facility: Sopron Medical Egeszsegugyi Szolgaltato Kft.

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone, With Adjunctive Clarithromycin, in the Treatment of Adult Subjects With Community-Acquired Pneumonia

acronym: CAP

summary: The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia

ReferenceCitation: Cheng K, Pypstra R, Yan JL, Hammond J. Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h. J Antimicrob Chemother. 2019 Apr 1;74(4):1086-1091. doi: 10.1093/jac/dky519.

family: Cheng

full_name: Karen Cheng

given: Karen

family: Pypstra

full_name: Rienk Pypstra

given: Rienk

family: Yan

full_name: Jean Li Yan

given: Jean Li

family: Hammond

full_name: Jennifer Hammond

given: Jennifer

journal_name: Journal of Antimicrobial Chemotherapy

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Taboada M, Melnick D, Iaconis JP, Sun F, Zhong NS, File TM, Llorens L, Friedland HD, Wilson D. Ceftaroline fosamil versus ceftriaxone for the treatment of community-acquired pneumonia: individual patient data meta-analysis of randomized controlled trials. J Antimicrob Chemother. 2016 Apr;71(4):862-70. doi: 10.1093/jac/dkv415. Epub 2015 Dec 24. Review. Erratum in: J Antimicrob Chemother. 2016 Jun;71(6):1748-9.

family: Taboada

full_name: Maria Taboada

given: Maria

family: Melnick

full_name: David Melnick

given: David

family: Iaconis

full_name: Joseph P. Iaconis

given: Joseph P.

family: Sun

full_name: Fang Sun

given: Fang

family: Zhong

full_name: Nan Shan Zhong

given: Nan Shan

family: File

full_name: Thomas M. File

given: Thomas M.

family: Llorens

full_name: Lily Llorens

given: Lily

family: Friedland

full_name: H. David Friedland

given: H. David

family: Wilson

full_name: David Wilson

oa_host_type: publisher

evidence: open (via free pdf)

ReferenceCitation: Lodise TP, Anzueto AR, Weber DJ, Shorr AF, Yang M, Smith A, Zhao Q, Huang X, File TM. Assessment of time to clinical response, a proxy for discharge readiness, among hospitalized patients with community-acquired pneumonia who received either ceftaroline fosamil or ceftriaxone in two phase III FOCUS trials. Antimicrob Agents Chemother. 2015 Feb;59(2):1119-26. doi: 10.1128/AAC.03643-14. Epub 2014 Dec 8.

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

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

title: Assessment of Time to Clinical Response, a Proxy for Discharge Readiness, among Hospitalized Patients with Community-Acquired Pneumonia Who Received either Ceftaroline Fosamil or Ceftriaxone in Two Phase III FOCUS Trials

ReferenceCitation: Shorr AF, Kollef M, Eckburg PB, Llorens L, Friedland HD. Assessment of ceftaroline fosamil in the treatment of community-acquired bacterial pneumonia due to Streptococcus pneumoniae: insights from two randomized trials. Diagn Microbiol Infect Dis. 2013 Mar;75(3):298-303. doi: 10.1016/j.diagmicrobio.2012.12.002. Epub 2013 Jan 26.

journal_name: Diagnostic Microbiology and Infectious Disease

ReferenceCitation: File TM Jr, Low DE, Eckburg PB, Talbot GH, Friedland HD, Lee J, Llorens L, Critchley IA, Thye DA; FOCUS 1 investigators. FOCUS 1: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia. J Antimicrob Chemother. 2011 Apr;66 Suppl 3:iii19-32. doi: 10.1093/jac/dkr096.

ReferenceCitation: Rank DR, Friedland HD, Laudano JB. Integrated safety summary of FOCUS 1 and FOCUS 2 trials: Phase III randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with community-acquired pneumonia. J Antimicrob Chemother. 2011 Apr;66 Suppl 3:iii53-9. doi: 10.1093/jac/dkr099.

location_country:
Malaysia
Romania
Russian Federation
Ukraine
India
France
Poland
Lithuania
Slovakia
Thailand
Argentina
South Africa
Switzerland
Bulgaria
Hungary
Germany
United States
Austria
Brazil
Serbia
Georgia
Spain
Estonia

location_facility:
InvestigationalSite
Investigational site
Investigational Site
Slovakia
Inestigational Site
Investigational Site 2
Investigational Site 1


title: A Randomized, Multi-Dose, Open-Label, Phase II Study of BMS-663513 as a Second-Line Monotherapy in Subjects With Previously Treated Unresectable Stage III or IV Melanoma

summary: The main purpose of this study is to estimate the proportion of patients with a type of skin cancer called melanoma who are progression free, (that is, the cancer has not gotten substantially worse), when treated with Anti-CD137 (4-1BB) (BMS-663513) at 0.1 mg/kg, 1 mg/kg or 5 mg/kg every 3 weeks or 1 mg/kg every 6 weeks

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Germany
France
Denmark
United States
Canada

location_facility: Blumenthal Cancer Center, Carolinas Medical Center

location_facility: Harry & Jeanette Weinberg Cancer Inst At Franklin Square

location_facility: Indiana University Melvin And Bren Simon Cancer Center


type: Other Identifier

type: Registry Identifier

title: Effect of γ-Secretase Inhibition on the Progression of Alzheimer's Disease: LY450139 Versus Placebo

summary:
Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta-amyloid (β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (γ-secretase) lowers the production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in blood, spinal fluid, and brain in animals tested thus far. This study used several different tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some participants. The build-up of amyloid plaques was measured by a brain scan that takes a picture of amyloid plaques in the brain. Other tests measured the overall function of the brain and brain size in some participants. In this trial, participants who initially received placebo (inactive sugar pill) were, at a certain point in the study, switched over to active drug, semagacestat. In other words, all participants could eventually receive active drug. Participation could last approximately 2 years. Participants taking approved AD medications were permitted to participate in this study and continue taking these medications during the study. All participants who completed this study had the option to continue receiving semagacestat by participating in an open-label study.

Preliminary results from this study (H6L-MC-LFAN [LFAN]) and another similar study (H6L-MC-LFBC [LFBC; NCT00762411]) showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC, and open-label H6L-MC-LFBF (LFBF; NCT01035138) were amended to continue collecting safety data, including cognitive scores, for at least 7 months. The Clinical Trial Registry (CTR) will reflect results of analyses from the original LFAN protocol in addition to those from the amended LFAN protocol.

ReferenceCitation: Liu-Seifert H, Siemers E, Price K, Han B, Selzler KJ, Henley D, Sundell K, Aisen P, Cummings J, Raskin J, Mohs R; Alzheimer's Disease Neuroimaging Initiative. Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer's Disease. J Alzheimers Dis. 2015;47(1):205-14. doi: 10.3233/JAD-142508.

name: Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA

family: Liu-Seifert

full_name: Hong Liu-Seifert

given: Hong

family: Siemers

full_name: Eric Siemers

given: Eric

family: Price

full_name: Karen Price

family: Han

full_name: Baoguang Han

given: Baoguang

family: Selzler

full_name: Katherine J. Selzler

given: Katherine J.

name: Indiana University School of Medicine, Indianapolis, IN, USA

family: Henley

full_name: David Henley

family: Sundell

full_name: Karen Sundell

name: Department of Neurosciences, University of California San Diego, San Diego, CA, USA

family: Aisen

full_name: Paul Aisen

given: Paul

name: Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA

family: Cummings

full_name: Jeffrey Cummings

given: Jeffrey

family: Raskin

full_name: Joel Raskin

given: Joel

family: Mohs

full_name: Richard Mohs

given: Richard

name: the Alzheimer’s Disease Neuroimaging Initiative

journal_name: Journal of Alzheimer's Disease

oa_host_type: repository

repository_institution: Indiana University - IUScholarWorks

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_institution:
Indiana University - IUScholarWorks
PubMed Central - Europe PMC

publisher: IOS Press

publisher_dissemination: IOS Press

publisher_group: IOS Press

publisher_normalized: IOS Press

title: Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer’s Disease

ReferenceCitation: Henley DB, Dowsett SA, Chen YF, Liu-Seifert H, Grill JD, Doody RS, Aisen P, Raman R, Miller DS, Hake AM, Cummings J. Alzheimer's disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther. 2015 Jun 25;7(1):43. doi: 10.1186/s13195-015-0127-0. eCollection 2015.

full_name: David B Henley

given: David B

family: Dowsett

full_name: Sherie A Dowsett

given: Sherie A

family: Chen

full_name: Yun-Fei Chen

given: Yun-Fei

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

title: Alzheimer’s disease progression by geographical region in a clinical trial setting

ReferenceCitation: Doody RS, Raman R, Sperling RA, Seimers E, Sethuraman G, Mohs R, Farlow M, Iwatsubo T, Vellas B, Sun X, Ernstrom K, Thomas RG, Aisen PS; Alzheimer's Disease Cooperative Study. Peripheral and central effects of γ-secretase inhibition by semagacestat in Alzheimer's disease. Alzheimers Res Ther. 2015 Jun 10;7(1):36. doi: 10.1186/s13195-015-0121-6. eCollection 2015.

name: for the Alzheimer’s Disease Cooperative Study

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

title: Peripheral and central effects of γ-secretase inhibition by semagacestat in Alzheimer’s disease

ReferenceCitation: Doody RS, Raman R, Farlow M, Iwatsubo T, Vellas B, Joffe S, Kieburtz K, He F, Sun X, Thomas RG, Aisen PS; Alzheimer's Disease Cooperative Study Steering Committee, Siemers E, Sethuraman G, Mohs R; Semagacestat Study Group. A phase 3 trial of semagacestat for treatment of Alzheimer's disease. N Engl J Med. 2013 Jul 25;369(4):341-50. doi: 10.1056/NEJMoa1210951.

title: A Phase 3 Trial of Semagacestat for Treatment of Alzheimer's Disease

location_country:
Italy
United States
Chile
South Africa
India
Sweden
Germany
Finland
France
Japan
Poland
Israel
Belgium
Argentina
Australia
Spain
Denmark
Canada
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: Kollef MH, Chastre J, Clavel M, Restrepo MI, Michiels B, Kaniga K, Cirillo I, Kimko H, Redman R. A randomized trial of 7-day doripenem versus 10-day imipenem-cilastatin for ventilator-associated pneumonia. Crit Care. 2012 Nov 13;16(6):R218. doi: 10.1186/cc11862.

family: Kollef

full_name: Marin H Kollef

given: Marin H

family: Chastre

full_name: Jean Chastre

given: Jean

family: Clavel

full_name: Marc Clavel

given: Marc

family: Restrepo

full_name: Marcos I Restrepo

given: Marcos I

family: Michiels

full_name: Bart Michiels

given: Bart

family: Kaniga

full_name: Koné Kaniga

given: Koné

family: Cirillo

full_name: Iolanda Cirillo

given: Iolanda

family: Kimko

full_name: Holly Kimko

given: Holly

family: Redman

full_name: Rebecca Redman

given: Rebecca

currency_apc_doaj: GBP

journal_name: Critical Care

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: Washington University School of Medicine - Digital Commons@Becker

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

status: Terminated

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
Guatemala
Romania
Belgium
Australia
Russian Federation
Ukraine
India
France
Thailand
Argentina
Canada
Philippines
Hungary
Portugal
Germany
United States
Brazil
Mexico
Israel
Spain
Turkey

type: EudraCT Number

source: euctr

title: A Prospective, Randomized, Double-Blind, Double-Dummy, Multicenter Study to Assess the Safety and Efficacy of Doripenem Compared With Imipenem-Cilastatin in the Treatment of Subjects With Ventilator-Associated Pneumonia

summary: The purpose of this study is to show that doripenem is as effective as imipenem-cilastatin in the treatment of patients with ventilator-associated pneumonia.

status_simplified: Unknown


title: Phase II, Multicenter, Open-label, Clinical Trial of Trabectedin (Yondelis) in Metastatic Breast Cancer Patients With Triple Negative Profile (ER-, PR-, HER2-), HER2 Overexpressing Tumors and BRCA1 or BRCA2 Mutation Carriers

summary: The purpose of this study is to evaluate the effectiveness and safety of trabectedin in 3 subpopulations of participants with previously treated progressive metastatic ( spread of a cancer from one organ or part to another non-adjacent organ or part) breast cancer (abnormal tissue that grows and spreads in the body until it kills) participants.

design_allocation: Non-Randomized

ReferenceCitation: Delaloge S, Wolp-Diniz R, Byrski T, Blum JL, Gonçalves A, Campone M, Lardelli P, Kahatt C, Nieto A, Cullell-Young M, Lubinski J. Activity of trabectedin in germline BRCA1/2-mutated metastatic breast cancer: results of an international first-in-class phase II study. Ann Oncol. 2014 Jun;25(6):1152-8. doi: 10.1093/annonc/mdu134. Epub 2014 Apr 1.

family: Delaloge

full_name: S. Delaloge

given: S.

family: Wolp-Diniz

full_name: R. Wolp-Diniz

given: R.

family: Byrski

full_name: T. Byrski

given: T.

family: Blum

full_name: J.L. Blum

family: Gonçalves

full_name: A. Gonçalves

given: A.

family: Campone

full_name: M. Campone

given: M.

family: Lardelli

full_name: P. Lardelli

given: P.

family: Kahatt

full_name: C. Kahatt

given: C.

family: Nieto

full_name: A. Nieto

family: Cullell-Young

full_name: M. Cullell-Young

family: Lubinski

full_name: J. Lubinski

given: J.

journal_name: Annals of Oncology

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

location_country:
Israel
United States
France
Poland


lead_sponsor: Ipsen

location_country:
Italy
Netherlands
France
Czechia
Belgium
Spain
Germany
United Kingdom

location_facility: CH Régional Huy - Polyclinique A Rue Trois Ponts

location_facility: Unità Spinale, Azienda Ospedaliera Careggi

location_facility: General Urology Academisch Ziekenhuis Maastricht

location_facility: Hôpital Henri Gabrielle - Hôpitaux Civils de Lyon

location_facility: Erasmus MC, Universitair Medisch Centrum Rotterdam

title: A Phase II, International, Multi-centre, Prospective, Randomised, Parallel-group, Double-blind, Dose-ranging, Placebo-controlled, 12-week, Princeps Study to Assess the Efficacy and Safety of a One Injection Cycle With Either Botulinum Toxin Type-A (Dysport® 125, 250 or 500 Units) or Placebo Followed by an Optional 6-month Extension Phase in the Symptomatic Treatment of Micturition Urgency and Frequency in Continent Female Subjects Suffering From Idiopathic Overactive Bladder.

summary: The purpose of this study is to determine the optimal dose of botulinum toxin type A injected in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life of continent women suffering from idiopathic overactive bladder.


title: A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients With Metastatic Colorectal Cancer (MCRC) Treated With Irinotecan / 5-FU Combination (FOLFIRI) After Failure of an Oxaliplatin Based Regimen

acronym: VELOUR

summary:
The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease.

The secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV) aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.

ReferenceCitation: Lu L, Dercle L, Zhao B, Schwartz LH. Deep learning for the prediction of early on-treatment response in metastatic colorectal cancer from serial medical imaging. Nat Commun. 2021 Nov 17;12(1):6654. doi: 10.1038/s41467-021-26990-6.

family: Lu

full_name: Lin Lu

given: Lin

family: Dercle

full_name: Laurent Dercle

given: Laurent

family: Zhao

full_name: Binsheng Zhao

given: Binsheng

family: Schwartz

full_name: Lawrence H. Schwartz

given: Lawrence H.

bso_classification: Biology (fond.)

journal_name: Nature Communications

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Chau I, Fakih M, García-Alfonso P, Linke Z, Ruiz Casado A, Marques EP, Picard P, Celanovic M, Cartwright T. Safety and Effectiveness of Aflibercept + Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) for the Treatment of Patients with Metastatic Colorectal Cancer (mCRC) in Current Clinical Practice: OZONE Study. Cancers (Basel). 2020 Mar 11;12(3). pii: E657. doi: 10.3390/cancers12030657.

family: Chau

full_name: Ian Chau

given: Ian

family: Fakih

full_name: Marwan Fakih

given: Marwan

family: García-Alfonso

full_name: Pilar García-Alfonso

given: Pilar

family: Linke

full_name: Zdenĕk Linke

given: Zdenĕk

family: Ruiz Casado

full_name: Ana Ruiz Casado

given: Ana

family: Marques

full_name: Eduardo Polo Marques

given: Eduardo Polo

family: Picard

full_name: Pascaline Picard

given: Pascaline

family: Celanovic

full_name: Marina Celanovic

given: Marina

family: Cartwright

full_name: Thomas Cartwright

given: Thomas

currency_apc_doaj: CHF

journal_name: Cancers

ReferenceCitation: Ruff P, Van Cutsem E, Lakomy R, Prausova J, van Hazel GA, Moiseyenko VM, Soussan-Lazard K, Dochy E, Magherini E, Macarulla T, Papamichael D. Observed benefit and safety of aflibercept in elderly patients with metastatic colorectal cancer: An age-based analysis from the randomized placebo-controlled phase III VELOUR trial. J Geriatr Oncol. 2018 Jan;9(1):32-39. doi: 10.1016/j.jgo.2017.07.010. Epub 2017 Aug 12.

ReferenceCitation: Stanel SC, Sjöberg J, Salmonson T, Foggi P, Caleno M, Melchiorri D, Gravanis I, Tzogani K, Pignatti F. European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer. ESMO Open. 2017 May 2;2(2):e000190. doi: 10.1136/esmoopen-2017-000190. eCollection 2017. Review.

ReferenceCitation: Van Cutsem E, Joulain F, Hoff PM, Mitchell E, Ruff P, Lakomý R, Prausová J, Moiseyenko VM, van Hazel G, Cunningham D, Arnold D, Schmoll HJ, Ten Tije AJ, McKendrick J, Kröning H, Humblet Y, Grávalos C, Le-Guennec S, Andria M, Dochy E, Vishwanath RL, Macarulla T, Tabernero J. Aflibercept Plus FOLFIRI vs. Placebo Plus FOLFIRI in Second-Line Metastatic Colorectal Cancer: a Post Hoc Analysis of Survival from the Phase III VELOUR Study Subsequent to Exclusion of Patients who had Recurrence During or Within 6 Months of Completing Adjuvant Oxaliplatin-Based Therapy. Target Oncol. 2016 Jun;11(3):383-400. doi: 10.1007/s11523-015-0402-9.

ReferenceCitation: Tabernero J, Van Cutsem E, Lakomý R, Prausová J, Ruff P, van Hazel GA, Moiseyenko VM, Ferry DR, McKendrick JJ, Soussan-Lazard K, Chevalier S, Allegra CJ. Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial. Eur J Cancer. 2014 Jan;50(2):320-31. doi: 10.1016/j.ejca.2013.09.013. Epub 2013 Oct 16.

title: Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: Prespecified subgroup analyses from the VELOUR trial

ReferenceCitation: Van Cutsem E, Tabernero J, Lakomy R, Prenen H, Prausová J, Macarulla T, Ruff P, van Hazel GA, Moiseyenko V, Ferry D, McKendrick J, Polikoff J, Tellier A, Castan R, Allegra C. Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. J Clin Oncol. 2012 Oct 1;30(28):3499-506. Epub 2012 Sep 4.

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Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Ukraine
France
Poland
Norway
Argentina
Korea, Republic of
Turkey
South Africa
Chile
Sweden
Netherlands
Puerto Rico
Germany
United States
United Kingdom
Italy
Austria
Brazil
New Zealand
Spain
Estonia

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location_facility: Sanofi-Aventis Investigational Site Number 276004

location_facility: Sanofi-Aventis Investigational Site Number 410001

location_facility: Sanofi-Aventis Investigational Site Number 528005

location_facility: Sanofi-Aventis Investigational Site Number 380005

location_facility: Sanofi-Aventis Investigational Site Number 203002

location_facility: Sanofi-Aventis Investigational Site Number 036002


title: A Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical Clipping.

summary:
The aim of this study is to demonstrate that clazosentan, administered as a continuous intravenous infusion at 5 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH), reduces the incidence of cerebral vasospasm -related morbidity and all-cause mortality within 6 weeks post-aSAH treated by surgical clipping. The primary endpoint of the study is the occurrence of cerebral vasospasm-related morbidity, and mortality of all-causes within 6 weeks post-aSAH, defined by at least one of the following:

Death (all causes).
New cerebral infarct(s) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm.
Delayed ischemic neurological deficit (DIND) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm.
Neurological signs or symptoms (depending on state of consciousness), in the presence of confirmed cerebral vasospasm on angiography (DSA or CTA), leading to the administration of a valid rescue therapy.

An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet the primary endpoint and its individual morbidity components.

ReferenceCitation: Mayer SA, Aldrich EF, Bruder N, Hmissi A, Macdonald RL, Viarasilpa T, Marr A, Roux S, Higashida RT. Thick and Diffuse Subarachnoid Blood as a Treatment Effect Modifier of Clazosentan After Subarachnoid Hemorrhage. Stroke. 2019 Oct;50(10):2738-2744. doi: 10.1161/STROKEAHA.119.025682. Epub 2019 Aug 9.

name: From the Department of Neurology, Henry Ford Hospital, Detroit, MI (S.A.M., T.V.)

family: Mayer

full_name: Stephan A. Mayer

given: Stephan A.

name: University of Maryland, Baltimore (E.F.A.)

family: Aldrich

full_name: E. Francois Aldrich

given: E. Francois

name: Hopital de la Timone-Aix-Marseille Université, France (N.B.)

family: Bruder

full_name: Nicolas Bruder

given: Nicolas

name: Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland (A.H., A.M., S.R.)

family: Hmissi

full_name: Abdel Hmissi

given: Abdel

name: Division of Neurosurgery, Department of Surgery, St. Michael’s Hospital, University of Toronto, ON, Canada (R.L.M.)

family: Macdonald

full_name: R. Loch Macdonald

given: R. Loch

name: Division of Critical Care, Department of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand (T.V.)

family: Viarasilpa

full_name: Tanuwong Viarasilpa

given: Tanuwong

family: Marr

full_name: Angelina Marr

given: Angelina

family: Roux

full_name: Sebastien Roux

given: Sebastien

name: University of California San Francisco Medical Center (R.T.H.).

family: Higashida

full_name: Randall T. Higashida

given: Randall T.

journal_name: Stroke

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Macdonald RL, Higashida RT, Keller E, Mayer SA, Molyneux A, Raabe A, Vajkoczy P, Wanke I, Bach D, Frey A, Marr A, Roux S, Kassell N. Randomised trial of clazosentan, an endothelin receptor antagonist, in patients with aneurysmal subarachnoid hemorrhage undergoing surgical clipping (CONSCIOUS-2). Acta Neurochir Suppl. 2013;115:27-31. doi: 10.1007/978-3-7091-1192-5_7.

family: Keller

full_name: Emanuela Keller

given: Emanuela

family: Molyneux

full_name: Andy Molyneux

given: Andy

family: Raabe

full_name: Andreas Raabe

given: Andreas

family: Vajkoczy

full_name: Peter Vajkoczy

given: Peter

family: Wanke

full_name: Isabel Wanke

given: Isabel

family: Bach

full_name: Doris Bach

given: Doris

family: Frey

full_name: Aline Frey

given: Aline

journal_name: Cerebral Vasospasm: Neurovascular Events After Subarachnoid Hemorrhage

title: Randomised Trial of Clazosentan, an Endothelin Receptor Antagonist, in Patients with Aneurysmal Subarachnoid Hemorrhage Undergoing Surgical Clipping (CONSCIOUS-2)

ReferenceCitation: Macdonald RL, Higashida RT, Keller E, Mayer SA, Molyneux A, Raabe A, Vajkoczy P, Wanke I, Bach D, Frey A, Marr A, Roux S, Kassell N. Clazosentan, an endothelin receptor antagonist, in patients with aneurysmal subarachnoid haemorrhage undergoing surgical clipping: a randomised, double-blind, placebo-controlled phase 3 trial (CONSCIOUS-2). Lancet Neurol. 2011 Jul;10(7):618-25. doi: 10.1016/S1474-4422(11)70108-9. Epub 2011 Jun 2.

location_country:
Finland
Australia
Belgium
Russian Federation
Denmark
Ukraine
India
Croatia
France
Poland
Norway
Canada
Slovenia
Korea, Republic of
Sweden
Hong Kong
Switzerland
Singapore
China
United States
Germany
Italy
Austria
Serbia
Czechia
New Zealand
Spain
Turkey
Latvia

location_facility: Cliniques Universitaires Saint-Luc, Universite Catholique de

location_facility: Riga Eastern Clinical University Hospital

location_facility: Pole d'Anesthesie Reanimation, CHU D'Angers

location_facility: Scientific Research Institute of Neurosurgery by Burdenko

location_facility: Guangdong Province Chinese Medicine Hospital

location_facility: University of Virginia Health System-Department of Neurosurgery

location_facility: Neurochirurggische Universitatsklinik des Heidelberg

location_facility: University of Calgary Foothills Medical Center

location_facility: University Fur Neurochirurgie, SALK, Christian Doppler Hospital

location_facility: Thomas Jefferson University School of Medicine-Jefferson Hospital for Neuroscience

location_facility: Oddzial Kliniczny Kliniki Neurochirurgii i Neurotrumatologii Szpitala, Uniwersyteckiego w Krakowie

location_facility: Kathedra I Klinika Neurochirurghii I Neurotraumatologii Collegium Medicum im. L. Rydygiera w Bydgoszc

location_facility: University of Cincinnati-Department of Neurosurgery

location_facility: Thechnical University-Klinikum rechts der Isar

location_facility: Samodzielny Publiczny Szpital Kliniczny Slaskiej Akademii Medycznej w Katowicach

location_facility: Toronto Western Hospital, University of Toronto

location_facility: Katedra Klinika Neurochirurgii Akademii Medycznej w Gdansku

location_facility: Klinika Neurochirurgii AMB-Neurosurgery Clinic of Medical Academy

location_facility: A. P. Romodanov Institute of Neurosurgery

location_facility: Oregon Health & Science University-Oregon Stroke Center

location_facility: University Hospitals Case Medical Center-Department of Neurosurgery

location_facility: AKH University of Vienna, Medical University

location_facility: Virginia Commonwealth University-Department of Neurosurgery

location_facility: Landeskrankenhaus und Medizinische Universitat Graz

location_facility: Charite Universitatsmedizin Berlin-Neurochirurgische Klinik-CVK

location_facility: Universitätsklinik Bern Klinik für Neurochirurgie

location_facility: State University of New York at Stony Brook-Health Sciences Center

location_facility: Katedra IKlinika Neurochirurgii Akademii Medycznej w Warszawie Clinic

location_facility: Sozialmedizinisches Zentrum Ost (ZMZ-Ost) Donauspital Vienna

location_facility: Haukeland University Hospital Helse Bergen HF

location_facility: Universitatsklinik Frankfurt, Klinik und Poliklinik fur Neurochirurgie

location_facility: Ibn-i Sina Hastanesi Ankara & Ankara Universitesi Tip Fakultesi

location_facility: Hopital Neurologique et Neuro-Chirurgical Pierre Wertheimer

location_facility: Azienda Ospedaliero-Universitaria di Careggi

location_facility: Katedra I Klinika Neurochirurgii i Dzieciecej

location_facility: XuanWu Hospital Institute of Brain Vascular Disease

location_facility: Post Graduate Institute of Medical Education and Research

location_facility: Uppsala University Hospital-Uppsala Akademiska Sjukhus

location_facility: All India Insititute of Medicla Sciences (AIIMS)


ReferenceType: background

ReferenceCitation: Mathis MV, Muoio BM, Andreason P, Avila AM, Farchione T, Atrakchi A, Temple RJ. The US Food and Drug Administration's Perspective on the New Antipsychotic Pimavanserin. J Clin Psychiatry. 2017 Jun;78(6):e668-e673. doi: 10.4088/JCP.16r11119. Review.

ReferenceCitation: Ballard C, Isaacson S, Mills R, Williams H, Corbett A, Coate B, Pahwa R, Rascol O, Burn DJ. Impact of Current Antipsychotic Medications on Comparative Mortality and Adverse Events in People With Parkinson Disease Psychosis. J Am Med Dir Assoc. 2015 Oct 1;16(10):898.e1-7. doi: 10.1016/j.jamda.2015.06.021. Epub 2015 Aug 1.

family: Ballard

full_name: Clive Ballard

given: Clive

family: Isaacson

full_name: Stuart Isaacson

given: Stuart

family: Mills

full_name: Roger Mills

given: Roger

family: Williams

full_name: Hilde Williams

given: Hilde

family: Corbett

full_name: Anne Corbett

given: Anne

family: Coate

full_name: Bruce Coate

given: Bruce

family: Pahwa

full_name: Rajesh Pahwa

given: Rajesh

family: Rascol

full_name: Olivier Rascol

given: Olivier

family: Burn

full_name: David J. Burn

given: David J.

journal_name: Journal of the American Medical Directors Association

lead_sponsor: ACADIA Pharmaceuticals Inc.

location_country:
Italy
Austria
United States
Sweden
India
Serbia
France
Poland
Belgium
Russian Federation
Portugal
Canada
United Kingdom
Ukraine

ipd_sharing: No

title: A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease

summary: To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.


ReferenceCitation: Meneghini L, Mersebach H, Kumar S, Svendsen AL, Hermansen K. Comparison of 2 intensification regimens with rapid-acting insulin aspart in type 2 diabetes mellitus inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs: the step-wise randomized study. Endocr Pract. 2011 Sep-Oct;17(5):727-36. doi: 10.4158/EP10367.OR.

family: Meneghini

full_name: Luigi Meneghini

given: Luigi

family: Mersebach

full_name: Henriette Mersebach

given: Henriette

family: Kumar

full_name: Sudhesh Kumar

given: Sudhesh

family: Svendsen

full_name: Anne Louise Svendsen

given: Anne Louise

family: Hermansen

full_name: Kjeld Hermansen

given: Kjeld

journal_name: Endocrine Practice

title: Comparison of 2 Intensification Regimens with Rapid-Acting Insulin Aspart in Type 2 Diabetes Mellitus Inadequately Controlled by Once-Daily Insulin Detemir and Oral Antidiabetes Drugs: The Step-Wise Randomized Study

lead_sponsor: Novo Nordisk A/S

location_country:
South Africa
Sweden
Former Serbia and Montenegro
Netherlands
Finland
France
Norway
Russian Federation
Spain
Denmark
United States
United Kingdom

title: Comparison of the Efficacy and Safety of Step-wise Addition of Short Acting Insulin Analogue Insulin Aspart to Once Daily Insulin Detemir and Oral Anti-diabetic Treatment in Patients With Type 2 Diabetes

summary:
This trial is conducted in Europe, Africa and the United States of America (USA).

The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.


title: A Phase 2 Double-Blind Randomized Study of Oral Enzastaurin HCl Versus Placebo Concurrently With Pemetrexed (Alimta®) as Second-Line Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

summary: The purpose of this study is to determine if the combination of enzastaurin and pemetrexed can extend survival time without progression of disease for participants who have advanced or metastatic non-small cell lung cancer (NSCLC).

lead_sponsor: Eli Lilly and Company

location_country:
Italy
United States
France
Portugal
Germany
Korea, Republic of

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: Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury - Phase 1 PALIVE 1 (for Pediatric Acute Lung Injury Mechanical VEntilation Strategies)

summary: PALIVE 1 is an observational multicenter study on mechanical ventilation strategies used in children with an acute lung injury (ALI). The objective of the study is to describe mechanical ventilation strategies in children with an ALI. Our hypothesis is that daily clinical practice is heterogenous among pediatric intensivists as few pediatric data exists on optimal mechanical ventilation strategies in this group of patients. Furthermore, different strategies may affect patient outcome.

study_type: Observational

time_perspective: Prospective

lead_sponsor: St. Justine's Hospital

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

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Centre Hospitalier Universitaire de Quebec

location_facility: General University Hospital Gregorio Marañón

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hospital Universitario Central de Asturias

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Hospital Sant Joan de Déu-Hospital Clinic

lead_sponsor_type: academique


ReferenceCitation: Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12.

family: Sullivan

full_name: Sean D Sullivan

given: Sean D

family: Alfonso-Cristancho

full_name: Rafael Alfonso-Cristancho

given: Rafael

family: Conner

full_name: Chris Conner

given: Chris

family: Hammer

full_name: Mette Hammer

given: Mette

family: Blonde

full_name: Lawrence Blonde

given: Lawrence

journal_name: Cardiovascular Diabetology

ReferenceCitation: McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998. Review.

family: McGill

full_name: Janet B. McGill

given: Janet B.

journal_name: Postgraduate Medicine

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Insights from the Liraglutide Clinical Development Program—the Liraglutide Effect and Action in Diabetes (LEAD) Studies

ReferenceCitation: Buse JB, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett JH, Zychma M, Blonde L; LEAD-6 Study Group. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet. 2009 Jul 4;374(9683):39-47. doi: 10.1016/S0140-6736(09)60659-0. Epub 2009 Jun 8.

family: Buse

full_name: John B Buse

given: John B

family: Rosenstock

full_name: Julio Rosenstock

given: Julio

family: Sesti

full_name: Giorgio Sesti

given: Giorgio

family: Schmidt

full_name: Wolfgang E Schmidt

given: Wolfgang E

family: Montanya

full_name: Eduard Montanya

given: Eduard

family: Brett

full_name: Jason H Brett

given: Jason H

family: Zychma

full_name: Marcin Zychma

given: Marcin

ReferenceCitation: Buse JB, Sesti G, Schmidt WE, Montanya E, Chang CT, Xu Y, Blonde L, Rosenstock J; Liraglutide Effect Action in Diabetes-6 Study Group. Switching to once-daily liraglutide from twice-daily exenatide further improves glycemic control in patients with type 2 diabetes using oral agents. Diabetes Care. 2010 Jun;33(6):1300-3. doi: 10.2337/dc09-2260. Epub 2010 Mar 23.

name: for the Liraglutide Effect Action in Diabetes (LEAD)-6 Study Group

repositories_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

title: Switching to Once-Daily Liraglutide From Twice-Daily Exenatide Further Improves Glycemic Control in Patients With Type 2 Diabetes Using Oral Agents

ReferenceCitation: Schmidt WE, Christiansen JS, Hammer M, Zychma MJ, Buse JB. Patient-reported outcomes are superior in patients with Type 2 diabetes treated with liraglutide as compared with exenatide, when added to metformin, sulphonylurea or both: results from a randomized, open-label study. Diabet Med. 2011 Jun;28(6):715-23. doi: 10.1111/j.1464-5491.2011.03276.x.

ReferenceCitation: Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbæk N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.

journal_name: The Journal of Clinical Endocrinology & Metabolism

title: Liraglutide Treatment Is Associated with a Low Frequency and Magnitude of Antibody Formation with No Apparent Impact on Glycemic Response or Increased Frequency of Adverse Events: Results from the Liraglutide Effect and Action in Diabetes (LEAD) Trials

ReferenceCitation: Valentine WJ, Palmer AJ, Lammert M, Langer J, Brändle M. Evaluating the long-term cost-effectiveness of liraglutide versus exenatide BID in patients with type 2 diabetes who fail to improve with oral antidiabetic agents. Clin Ther. 2011 Nov;33(11):1698-712. doi: 10.1016/j.clinthera.2011.09.022. Epub 2011 Oct 21.

title: Evaluating the Long-Term Cost-Effectiveness of Liraglutide Versus Exenatide BID in Patients With Type 2 Diabetes Who Fail to Improve With Oral Antidiabetic Agents

ReferenceCitation: Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes ≥65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4.

journal_name: The American Journal of Geriatric Pharmacotherapy

title: Comparison of the Efficacy and Tolerability Profile of Liraglutide, a Once-Daily Human GLP-1 Analog, in Patients With Type 2 Diabetes ≥65 and <65 Years of Age: A Pooled Analysis from Phase III Studies

ReferenceCitation: Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13.

ReferenceCitation: Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.

ReferenceCitation: Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.

name: Division of Diabetes, Endocrinology and Metabolism, Department of Medicine; Vanderbilt University School of Medicine; Nashville; TN; USA

name: Division of Endocrinology Diabetes and Nutrition, St Luke's-Roosevelt Hospital, Columbia University; New York; NY; USA

name: Diabetes Care Center; University of North Carolina School of Medicine; Chapel Hill; NC; USA

name: Novo Nordisk Pharma Ltd; Crawley; West Sussex; UK

name: Department of Diabetes and Endocrinology, Royal Surrey County Hospital, University of Surrey; Guildford; Surrey; UK

name: Samuel Lunenfeld Research Institute; Mount Sinai Hospital, University of Toronto; Toronto; ON; Canada

ReferenceCitation: Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.

title: A meta-analysis of serious adverse events reported with exenatide and liraglutide: Acute pancreatitis and cancer

ReferenceCitation: King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.

title: Liraglutide Achieves A1C Targets More often than Sitagliptin or Exenatide when Added to Metformin in Patients with Type 2 Diabetes and a Baseline A1C <8.0%

ReferenceCitation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Review. Erratum in: Diabetes Care. 2015 Aug;38(8):1622.

title: Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical Trials

ReferenceCitation: Davidson JA, Ørsted DD, Campos C. Efficacy and safety of liraglutide, a once-daily human glucagon-like peptide-1 analogue, in Latino/Hispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials. Diabetes Obes Metab. 2016 Jul;18(7):725-8. doi: 10.1111/dom.12653. Epub 2016 Apr 28.

name: Touchstone Diabetes Center Dallas University of Texas Southwestern Medical Center  Dallas TX USA

name: UT Health Science Center  San Antonio TX USA

title: Efficacy and safety of liraglutide, a once‐daily human glucagon‐like peptide‐1 analogue, in L atino/ H ispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials

ReferenceCitation: Fonseca VA, Devries JH, Henry RR, Donsmark M, Thomsen HF, Plutzky J. Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: insights from a patient-level pooled analysis of six randomized clinical trials. J Diabetes Complications. 2014 May-Jun;28(3):399-405. doi: 10.1016/j.jdiacomp.2014.01.009. Epub 2014 Jan 21.

journal_name: Journal of Diabetes and its Complications

title: Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: Insights from a patient-level pooled analysis of six randomized clinical trials

location_country: Macedonia, The Former Yugoslav Republic of

title: Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes

summary: This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.


title: An International Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral Lacosamide (SPM 927) in Patients With Partial Seizures

summary: The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.

ReferenceCitation: Borghs S, de la Loge C, Brabant Y, Cramer J. Sensitivity testing of the Seizure Severity Questionnaire (SSQ). Epilepsy Behav. 2014 Feb;31:281-5. doi: 10.1016/j.yebeh.2013.10.010. Epub 2013 Nov 22.

family: Borghs

full_name: Simon Borghs

given: Simon

family: de la Loge

full_name: Christine de la Loge

given: Christine

family: Brabant

full_name: Yves Brabant

given: Yves

family: Cramer

full_name: Joyce Cramer

given: Joyce

journal_name: Epilepsy & Behavior

ReferenceCitation: Rosenow F, Kelemen A, Ben-Menachem E, McShea C, Isojarvi J, Doty P; SP774 study investigators. Long-term adjunctive lacosamide treatment in patients with partial-onset seizures. Acta Neurol Scand. 2016 Feb;133(2):136-144. doi: 10.1111/ane.12451. Epub 2015 Jul 2.

name: Epilepsy Center Frankfurt Rhine-Main; Center of Neurology and Neurosurgery; Goethe University; Frankfurt a. M Germany

family: Rosenow

full_name: F. Rosenow

given: F.

name: National Institute of Neurosciences; Budapest Hungary

family: Kelemen

full_name: A. Kelemen

given: A.

name: Institute of Clinical Neurosciences; Division of Neurology; Sahlgrenska Academy; University of Gothenburg; Gothenburg Sweden

family: Ben-Menachem

full_name: E. Ben-Menachem

given: E.

family: McShea

full_name: C. McShea

given: C.

family: Isojarvi

full_name: J. Isojarvi

given: J.

family: Doty

full_name: P. Doty

given: P.

journal_name: Acta Neurologica Scandinavica

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: UCB Pharma

location_country:
Sweden
Finland
Croatia
Czechia
France
Lithuania
Poland
Hungary
Australia
Russian Federation
Spain
Germany
United Kingdom


lead_sponsor: AbbVie (prior sponsor, Abbott)

location_country:
Italy
United States
Mexico
France
Puerto Rico
Germany
Canada

location_facility:
Site Reference ID/Investigator# 6763
Site Reference ID/Investigator# 7514
Site Reference ID/Investigator# 7699
Site Reference ID/Investigator# 5277
Site Reference ID/Investigator# 8497
Site Reference ID/Investigator# 8113
Site Reference ID/Investigator# 7064
Site Reference ID/Investigator# 6732
Site Reference ID/Investigator# 7696
Site Reference ID/Investigator# 5276
Site Reference ID/Investigator# 6047
Site Reference ID/Investigator# 5034
Site Reference ID/Investigator# 7187
Site Reference ID/Investigator# 5950
Site Reference ID/Investigator# 8286
Site Reference ID/Investigator# 6781
Site Reference ID/Investigator# 8481
Site Reference ID/Investigator# 7387
Site Reference ID/Investigator# 6044
Site Reference ID/Investigator# 7906
Site Reference ID/Investigator# 8121
Site Reference ID/Investigator# 7483
Site Reference ID/Investigator# 6053
Site Reference ID/Investigator# 5018
Site Reference ID/Investigator# 5899
Site Reference ID/Investigator# 6043
Site Reference ID/Investigator# 6054
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title: A Global, Multicenter, Randomized, Double-Blind Placebo Controlled Study Comparing the Safety and Efficacy of ABT-894, Duloxetine and Placebo in Subjects With Diabetic Neuropathic Pain

summary: This study will compare the efficacy and the safety of ABT-894 (1mg, 2mg or 4mg capsules) administered BID to placebo in the treatment of DNP. Another treatment arm will be Duloxetine 60mg administered once daily (QD). Approximately 275 subjects will be enrolled into the study at approximately 50 sites in both the United States and Europe. The study will be divided into the following periods: Screening/Washout (21 days) followed by a Baseline Visit, an 8-week Treatment Period and a 1-week Follow-up Visit.


title: A Randomized, Double-blind, Double-dummy, Multicenter Parallel Group Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil Versus Vardenafil PRN Versus Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving Erectile Function

summary: A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed' (immediately before intended sexual activity) compared to placebo, to evaluate its tolerability and if it can help in recovery of erections after a nerve sparing radical prostatectomy.

lead_sponsor: Bayer

location_country:
Italy
Austria
United States
South Africa
Sweden
Switzerland
Netherlands
Germany
Finland
France
Norway
Belgium
Spain
Canada
United Kingdom


ReferenceCitation: Adedokun OJ, Xu Z, Liao S, Strauss R, Reinisch W, Feagan BG, Sandborn WJ. Population Pharmacokinetics and Exposure-Response Modeling of Golimumab in Adults With Moderately to Severely Active Ulcerative Colitis. Clin Ther. 2020 Jan;42(1):157-174.e4. doi: 10.1016/j.clinthera.2019.11.010. Epub 2020 Jan 22.

family: Adedokun

full_name: Omoniyi J. Adedokun

given: Omoniyi J.

family: Xu

full_name: Zhenhua Xu

given: Zhenhua

family: Liao

full_name: Sam Liao

given: Sam

family: Strauss

full_name: Richard Strauss

given: Richard

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Feagan

full_name: Brian G. Feagan

given: Brian G.

family: Sandborn

full_name: William J. Sandborn

given: William J.

journal_name: Clinical Therapeutics

title: Population Pharmacokinetics and Exposure–Response Modeling of Golimumab in Adults With Moderately to Severely Active Ulcerative Colitis

ReferenceCitation: Li K, Strauss R, Marano C, Greenbaum LE, Friedman JR, Peyrin-Biroulet L, Brodmerkel C, De Hertogh G. A Simplified Definition of Histologic Improvement in Ulcerative Colitis and its Association With Disease Outcomes up to 30 Weeks from Initiation of Therapy: Post Hoc Analysis of Three Clinical Trials. J Crohns Colitis. 2019 Aug 14;13(8):1025-1035. doi: 10.1093/ecco-jcc/jjz022.

name: Janssen Research & Development, LLC, Immunology Therapeutic Area, Spring House, Pennsylvania, USA

family: Li

full_name: Katherine Li

given: Katherine

family: Marano

full_name: Colleen Marano

given: Colleen

name: Novartis Institutes for Biomedical Research, East Hanover, New Jersey, USA

family: Greenbaum

full_name: Linda E Greenbaum

given: Linda E

family: Friedman

full_name: Joshua R Friedman

given: Joshua R

name: INSERM Unité 954 and Department of Hepato-Gastroenterology, University Hospital of Nancy, Nancy, France

family: Peyrin-Biroulet

full_name: Laurent Peyrin-Biroulet

given: Laurent

family: Brodmerkel

full_name: Carrie Brodmerkel

given: Carrie

name: Department of Imaging & Pathology, Translational Cell & Tissue Research, University Hospitals Leuven, Leuven, Belgium

family: De Hertogh

full_name: Gert De Hertogh

given: Gert

journal_name: Journal of Crohn's and Colitis

ReferenceCitation: Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Colombel JF, Reinisch W, Gibson PR, Collins J, Järnerot G, Hibi T, Rutgeerts P; PURSUIT-SC Study Group. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan;146(1):85-95; quiz e14-5. doi: 10.1053/j.gastro.2013.05.048. Epub 2013 Jun 2.

family: Zhang

title: Subcutaneous Golimumab Induces Clinical Response and Remission in Patients With Moderate-to-Severe Ulcerative Colitis

location_country:
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Ukraine
India
France
Japan
Lithuania
Poland
Slovakia
Canada
South Africa
Sweden
Netherlands
Bulgaria
Hungary
Germany
United States
Austria
Serbia
Israel
New Zealand

title: A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with ulcerative colitis (UC).


location_country:
United States
Sweden
Netherlands
Germany
Finland
France
Hungary
Belgium
Spain
Canada
United Kingdom

title: Double-blind, Placebo-controlled, Randomized, Parallel-group Phase II Study in Subjects With Relapsing Forms of Multiple Sclerosis (MS) to Evaluate the Safety, Tolerability, and Effects of CDP323.

summary: The objective of the study is to evaluate the effect, safety and tolerability of CDP323 in patients with relapsing forms of multiple sclerosis


title: A Multi-Center, Randomised, Parallel Group, Double-Blind, Placebo Controlled Estimation Study To Assess The Efficacy And Safety Of Modified Release UK-369,003 In The Treatment Of Men With Storage Lower Urinary Tract Symptoms (LUTS) With And Without Erectile Dysfunction (ED).

summary: This is a 12 week study in which different doses of UK-369,003 will be administered to patients with a diagnosis of overactive bladder. Patients will complete a series of questionnaires before treatment, during treatment and after treatment, to assess whether UK-369,003 has improved their symptoms of overactive bladder and erectile function.

enrollment_type: Anticipated

lead_sponsor: Pfizer

location_country:
Italy
Chile
Switzerland
United Kingdom
Germany
Finland
France
Poland
Greece
Slovakia
Norway
Australia
Spain
Canada
Latvia
Colombia


title: A Double-blind, Placebo-controlled Titration Study to Investigate the Tolerability, Safety and Pharmacodynamic Profile of a GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

summary: This 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue (at a dose of 20mg, or a starting dose of 20mg escalating to either 30mg or 40mg), weekly. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

ReferenceCitation: Ratner R, Nauck M, Kapitza C, Asnaghi V, Boldrin M, Balena R. Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebo-controlled study. Diabet Med. 2010 May;27(5):556-62. doi: 10.1111/j.1464-5491.2010.02990.x. Erratum in: Diabet Med. 2010 Jun;27(6):732.

family: Ratner

full_name: R. Ratner

given: R.

family: Nauck

full_name: M. Nauck

given: M.

family: Kapitza

full_name: C. Kapitza

given: C.

family: Asnaghi

full_name: V. Asnaghi

given: V.

family: Boldrin

full_name: M. Boldrin

family: Balena

full_name: R. Balena

journal_name: Diabetic Medicine

title: Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebo-controlled study1,2

lead_sponsor: Hoffmann-La Roche

location_country:
United States
Peru
Mexico
France
Australia
Puerto Rico
Germany


title: A Double-Blind, Randomized, Phase 2 Trial of Capecitabine Plus Enzastaurin Versus Capecitabine Plus Placebo in Patients With Metastatic or Recurrent Breast Cancer Previously Treated With an Anthracycline and a Taxane

summary: The purpose of this study is to determine whether the combination of enzastaurin and capecitabine is more effective than the combination of placebo and capecitabine in treating participants with breast cancer who were previously treated with an anthracycline and a taxane.

ReferenceCitation: Clemons M, Joy AA, Abdulnabi R, Kotliar M, Lynch J, Jordaan JP, Iscoe N, Gelmon K. Phase II, double-blind, randomized trial of capecitabine plus enzastaurin versus capecitabine plus placebo in patients with metastatic or recurrent breast cancer after prior anthracycline and taxane therapy. Breast Cancer Res Treat. 2010 Nov;124(1):177-86. doi: 10.1007/s10549-010-1152-0. Epub 2010 Sep 3.

family: Clemons

full_name: Mark Clemons

given: Mark

family: Joy

full_name: Anil A. Joy

given: Anil A.

family: Abdulnabi

full_name: Radhi Abdulnabi

given: Radhi

family: Kotliar

full_name: Mauricio Kotliar

given: Mauricio

family: Lynch

full_name: Jodi Lynch

given: Jodi

family: Jordaan

full_name: Johan P. Jordaan

given: Johan P.

family: Iscoe

full_name: Neill Iscoe

given: Neill

family: Gelmon

full_name: Karen Gelmon

given: Karen

journal_name: Breast Cancer Research and Treatment

location_country:
South Africa
Mexico
France
Argentina
Australia


title: Study EGF107671 - a Phase II Study of Lapatinib Plus Topotecan or Lapatinib Plus Capecitabine in the Treatment of Recurrent Brain Metastases From ErbB2-Positive Breast Cancer Following Cranial Radiotherapy

summary: This study is for patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. The study will determine how safe and effective lapatinib is when given in combination with capecitabine to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed regularly during the course of the study.

ReferenceCitation: Lin NU, Eierman W, Greil R, Campone M, Kaufman B, Steplewski K, Lane SR, Zembryki D, Rubin SD, Winer EP. Randomized phase II study of lapatinib plus capecitabine or lapatinib plus topotecan for patients with HER2-positive breast cancer brain metastases. J Neurooncol. 2011 Dec;105(3):613-20. doi: 10.1007/s11060-011-0629-y. Epub 2011 Jun 26.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Austria
United States
Sweden
Germany
France
Greece
Israel
Belgium
Spain
Canada


title: Pertuzumab + Trastuzumab (PH) Versus PH Plus Metronomic Chemotherapy (PHM) in the Elderly HER2+ Metastatic Breast Cancer Population Who May Continue on T-DM1 Alone Following Disease Progression While on PH / PHM: an Open-label Multicentre Randomized Phase II Selection Trial of the EORTC Elderly Task Force and Breast Cancer Group

summary:
Chemotherapy and HER2 targeted agents can improve survival significantly in metastatic breast cancer. Chemotherapy however is associated with significant side-effects and can impact on Quality of Life and functionality in older patients.

The investigators aim to establish HER2 targeted regimens with minimal toxicity in order to delay or even avoid the use of classical chemotherapy because of competing risks of death in this frail/elderly patient group.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Wildiers H, Tryfonidis K, Dal Lago L, Vuylsteke P, Curigliano G, Waters S, Brouwers B, Altintas S, Touati N, Cardoso F, Brain E. Pertuzumab and trastuzumab with or without metronomic chemotherapy for older patients with HER2-positive metastatic breast cancer (EORTC 75111-10114): an open-label, randomised, phase 2 trial from the Elderly Task Force/Breast Cancer Group. Lancet Oncol. 2018 Mar;19(3):323-336. doi: 10.1016/S1470-2045(18)30083-4. Epub 2018 Feb 9.

family: Wildiers

full_name: Hans Wildiers

given: Hans

family: Tryfonidis

full_name: Konstantinos Tryfonidis

given: Konstantinos

family: Dal Lago

full_name: Lissandra Dal Lago

given: Lissandra

family: Vuylsteke

full_name: Peter Vuylsteke

given: Peter

family: Curigliano

full_name: Giuseppe Curigliano

given: Giuseppe

family: Waters

full_name: Simon Waters

given: Simon

family: Brouwers

full_name: Barbara Brouwers

given: Barbara

family: Altintas

full_name: Sevilay Altintas

given: Sevilay

family: Touati

full_name: Nathan Touati

given: Nathan

family: Cardoso

full_name: Fatima Cardoso

given: Fatima

family: Brain

full_name: Etienne Brain

given: Etienne

journal_name: The Lancet Oncology

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Italy
Sweden
Netherlands
Poland
France
Belgium
Portugal
United Kingdom

location_facility: VieCuri - Medisch Centrum voor Noord-Limburg - Locatie Venlo

location_facility: Uppsala University Hospital - Akademiska Sjukhuset

location_facility: University Hospital Southampton NHS Foundation Trust - Southampton General Hospital

location_facility: Peterborough and Stamford Hospitals NHS Foundation Trust - Peterborough City Hospita

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: Velindre NHS Trust - Velindre Cancer Centre

location_facility: Istituto Oncologico Veneto IRCCS - Ospedale Busonera

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

status_simplified: Ongoing


title: International GBS Outcome Study (IGOS): A Prospective INC Study on Clinical and Biological Predictors of Disease Course and Outcome in Guillain-Barré Syndrome (GBS).

acronym: IGOS

summary:
International GBS Outcome Study (IGOS) is a study conducted by the members of the Inflammatory Neuropathy Consortium (INC) and Peripheral Nerve Society (PNS) on disease course and outcome in Guillain-Barré syndrome (GBS).

The IGOS aims to identify clinical and biological determinants and predictors of disease course and outcome in individual patients with Guillain-Barré syndrome, as early as possible after onset of disease.

study_start_date_type: Actual

ReferenceCitation: Jacobs BC, van den Berg B, Verboon C, Chavada G, Cornblath DR, Gorson KC, Harbo T, Hartung HP, Hughes RAC, Kusunoki S, van Doorn PA, Willison HJ; IGOS Consortium. International Guillain-Barré Syndrome Outcome Study: protocol of a prospective observational cohort study on clinical and biological predictors of disease course and outcome in Guillain-Barré syndrome. J Peripher Nerv Syst. 2017 Jun;22(2):68-76. doi: 10.1111/jns.12209.

name: Department of Neurology, Erasmus MC; University Medical Center; Rotterdam The Netherlands

name: Department of Immunology, Erasmus MC; University Medical Center; Rotterdam The Netherlands

family: Jacobs

full_name: Bart C. Jacobs

given: Bart C.

family: van den Berg

full_name: Bianca van den Berg

given: Bianca

family: Verboon

full_name: Christine Verboon

given: Christine

name: Department of Neurology; University of Glasgow; Glasgow Scotland UK

family: Chavada

full_name: Govindsinh Chavada

given: Govindsinh

name: Department of Neurology; Johns Hopkins University; Baltimore MD USA

family: Cornblath

full_name: David R. Cornblath

given: David R.

name: Department of Neurology, St. Elizabeth's Medical Center; Tufts University School of Medicine; Boston MA USA

family: Gorson

full_name: Kenneth C. Gorson

given: Kenneth C.

name: Department of Neurology; Aarhus University Hospital; Aarhus Denmark

family: Harbo

full_name: Thomas Harbo

given: Thomas

name: Department of Neurology; University of Düsseldorf; Düsseldorf Germany

family: Hartung

full_name: Hans-Peter Hartung

given: Hans-Peter

name: Department of Neurology, Institute of Neurology; University College; London UK

family: Hughes

full_name: Richard A. C. Hughes

given: Richard A. C.

name: Department of Neurology; Kinki University School of Medicine; Osaka Japan

family: Kusunoki

full_name: Susumu Kusunoki

given: Susumu

family: van Doorn

full_name: Pieter A. van Doorn

given: Pieter A.

family: Willison

full_name: Hugh J. Willison

given: Hugh J.

journal_name: Journal of the Peripheral Nervous System

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

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

ipd_sharing: Undecided

lead_sponsor: Erasmus Medical Center

location_country:
Malaysia
Greece
Belgium
Australia
Denmark
Taiwan
France
Japan
Argentina
Canada
South Africa
Switzerland
Netherlands
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Bangladesh
Spain

location_facility: Wexner Medical Center at The Ohio State University

location_facility: The university of Texas Health Science Center

location_facility: University of Maryland School of Medicine

location_facility: National Hospital of Neurology and Neurosurgery

location_facility: Affiliated Hospital of Jining Medical University

location_facility: University of Vermont College of Medicine

location_facility: Concord Repatriation General Hospital Sydney

location_facility: Southern Illinois University School of Medicine

location_facility: The affiliated Hospital of Xuzhou Medical University