title: REGISTRY - an Observational Study of the European Huntington's Disease Network (EHDN)

acronym: REGISTRY

summary:
This is a multi-centre, multi-national, prospective, observational study of Huntington's disease (HD) with a control group of volunteers to:

obtain natural history data on many HD mutation carriers and individuals who are part of an HD family
relate phenotypical characteristics (genetic modifiers / wet and dry biomarkers)
expedite identification and recruitment of participants for clinical trials
develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of premanifest and manifest HD which may also be potential outcome measures for use in future clinical trials and clinical care
plan for future research studies

study_type: Observational

time_perspective: Other

ReferenceCitation: Rickards H, De Souza J, van Walsem M, van Duijn E, Simpson SA, Squitieri F, Landwehrmeyer B; European Huntington's Disease Network. Factor analysis of behavioural symptoms in Huntington's disease. J Neurol Neurosurg Psychiatry. 2011 Apr;82(4):411-2. doi: 10.1136/jnnp.2009.181149. Epub 2010 Apr 14.

ReferenceCitation: Orth M, Handley OJ, Schwenke C, Dunnett SB, Craufurd D, Ho AK, Wild E, Tabrizi SJ, Landwehrmeyer GB; Investigators of the European Huntington's Disease Network. Observing Huntington's Disease: the European Huntington's Disease Network's REGISTRY. PLoS Curr. 2010 Sep 28;2:RRN1184. doi: 10.1371/currents.RRN1184.

ReferenceCitation: Orth M; European Huntington's Disease Network; Handley OJ, Schwenke C, Dunnett S, Wild EJ, Tabrizi SJ, Landwehrmeyer GB. Observing Huntington's disease: the European Huntington's Disease Network's REGISTRY. J Neurol Neurosurg Psychiatry. 2011 Dec;82(12):1409-12. doi: 10.1136/jnnp.2010.209668. Epub 2010 Nov 19. No abstract available.

ReferenceCitation: Busse M, Al-Madfai DH, Kenkre J, Landwehrmeyer GB, Bentivoglio A, Rosser A; European Huntington's Disease Network. Utilisation of Healthcare and Associated Services in Huntington's disease: a data mining study. PLoS Curr. 2011 Jan 21;3:RRN1206. doi: 10.1371/currents.RRN1206.

ReferenceCitation: Lopez-Sendon JL, Royuela A, Trigo P, Orth M, Lange H, Reilmann R, Keylock J, Rickards H, Piacentini S, Squitieri F, Landwehrmeyer B, Witjes-Ane MN, Jurgens CK, Roos RA, Abraira V, de Yebenes JG; European HD Network. What is the impact of education on Huntington's disease? Mov Disord. 2011 Jul;26(8):1489-95. doi: 10.1002/mds.23385. Epub 2011 Mar 22.

ReferenceCitation: Ho AK, Hocaoglu MB; European Huntington's Disease Network Quality of Life Working Group. Impact of Huntington's across the entire disease spectrum: the phases and stages of disease from the patient perspective. Clin Genet. 2011 Sep;80(3):235-9. doi: 10.1111/j.1399-0004.2011.01748.x. Epub 2011 Aug 4.

ReferenceCitation: Quarrell OW, Handley O, O'Donovan K, Dumoulin C, Ramos-Arroyo M, Biunno I, Bauer P, Kline M, Landwehrmeyer GB; European Huntington's Disease Network. Discrepancies in reporting the CAG repeat lengths for Huntington's disease. Eur J Hum Genet. 2012 Jan;20(1):20-6. doi: 10.1038/ejhg.2011.136. Epub 2011 Aug 3.

ReferenceCitation: Saft C, Epplen JT, Wieczorek S, Landwehrmeyer GB, Roos RA, de Yebenes JG, Dose M, Tabrizi SJ, Craufurd D; REGISTRY Investigators of the European Huntington's Disease Network; Arning L. NMDA receptor gene variations as modifiers in Huntington disease: a replication study. PLoS Curr. 2011 Oct 4;3:RRN1247. doi: 10.1371/currents.RRN1247.

ReferenceCitation: Rickards H, De Souza J, Crooks J, van Walsem MR, van Duijn E, Landwehrmeyer B, Squitieri F, Simpson SA; European Huntington's Disease Network. Discriminant analysis of Beck Depression Inventory and Hamilton Rating Scale for Depression in Huntington's disease. J Neuropsychiatry Clin Neurosci. 2011 Fall;23(4):399-402. doi: 10.1176/jnp.23.4.jnp399.

ReferenceCitation: Lee JM, Ramos EM, Lee JH, Gillis T, Mysore JS, Hayden MR, Warby SC, Morrison P, Nance M, Ross CA, Margolis RL, Squitieri F, Orobello S, Di Donato S, Gomez-Tortosa E, Ayuso C, Suchowersky O, Trent RJ, McCusker E, Novelletto A, Frontali M, Jones R, Ashizawa T, Frank S, Saint-Hilaire MH, Hersch SM, Rosas HD, Lucente D, Harrison MB, Zanko A, Abramson RK, Marder K, Sequeiros J, Paulsen JS; PREDICT-HD study of the Huntington Study Group (HSG); Landwehrmeyer GB; REGISTRY study of the European Huntington's Disease Network; Myers RH; HD-MAPS Study Group; MacDonald ME, Gusella JF; COHORT study of the HSG. CAG repeat expansion in Huntington disease determines age at onset in a fully dominant fashion. Neurology. 2012 Mar 6;78(10):690-5. doi: 10.1212/WNL.0b013e318249f683. Epub 2012 Feb 8.

ReferenceCitation: Henley SM, Ridgway GR, Scahill RI, Kloppel S, Tabrizi SJ, Fox NC, Kassubek J; EHDN Imaging Working Group. Pitfalls in the use of voxel-based morphometry as a biomarker: examples from huntington disease. AJNR Am J Neuroradiol. 2010 Apr;31(4):711-9. doi: 10.3174/ajnr.A1939. Epub 2009 Dec 24.

ReferenceCitation: Aziz NA, Jurgens CK, Landwehrmeyer GB; EHDN Registry Study Group; van Roon-Mom WM, van Ommen GJ, Stijnen T, Roos RA. Normal and mutant HTT interact to affect clinical severity and progression in Huntington disease. Neurology. 2009 Oct 20;73(16):1280-5. doi: 10.1212/WNL.0b013e3181bd1121. Epub 2009 Sep 23. Erratum In: Neurology. 2009 Nov 10;73(19):1608. Neurology. 2011 Jan 11;76(2):202. Ciarmielo, Andrea [corrected to Ciarmiello, Andrea].

ReferenceCitation: Youssov K, Audureau E, Vandendriessche H, Morgado G, Layese R, Goizet C, Verny C, Bourhis ML, Bachoud-Levi AC. The burden of Huntington's disease: A prospective longitudinal study of patient/caregiver pairs. Parkinsonism Relat Disord. 2022 Oct;103:77-84. doi: 10.1016/j.parkreldis.2022.08.023. Epub 2022 Aug 24.

ReferenceCitation: McAllister B, Gusella JF, Landwehrmeyer GB, Lee JM, MacDonald ME, Orth M, Rosser AE, Williams NM, Holmans P, Jones L, Massey TH; REGISTRY Investigators of the European Huntington's Disease Network. Timing and Impact of Psychiatric, Cognitive, and Motor Abnormalities in Huntington Disease. Neurology. 2021 May 11;96(19):e2395-e2406. doi: 10.1212/WNL.0000000000011893. Epub 2021 Mar 25.

repository_institution: Cardiff University - ORCA Online Research @Cardiff

repositories_institution: Cardiff University - ORCA Online Research @Cardiff

ReferenceCitation: Cubo E, Ramos-Arroyo MA, Martinez-Horta S, Martinez-Descalls A, Calvo S, Gil-Polo C; European HD Network. Clinical manifestations of intermediate allele carriers in Huntington disease. Neurology. 2016 Aug 9;87(6):571-8. doi: 10.1212/WNL.0000000000002944. Epub 2016 Jul 8.

lead_sponsor: European Huntington's Disease Network

location_country:
Finland
Germany
Italy
Poland
Portugal
Norway
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
Czechia
Russian Federation
France

location_facility: Leiden University Medical Centre (LUMC), Neurology K5-Q

location_facility: Chapel Allerton Hospital, Yorkshire Regional Genetics Service

location_facility: Technische Universität München, Abteilung Neurologie

location_facility: Karolinska University Hospital - Huddinge Division, Neurology

location_facility: Isar-Amper-Klinikum - Klinik Taufkirchen (Vils)

location_facility: Azienda Ospedaliera S. Andrea, UOC Neurologia e Centro Neurologico Terapie Sperimentali CENTERS

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust, Neurosciences Directorate, Royal Preston Hospital

location_facility: Centrum extrapyramidových onemocnění, Neurologická klinika, 1. LFUK

location_facility: Gloucestershire Royal Hospital, Neurology Dept.

location_facility: Hospital Fernando Fonseca, Neurology Dept.

location_facility: Università di Napoli Federico II, Dip. Scienze Neurologiche Edificio 17

location_facility: Helsinki University Hospital, Dept. of Neurology

location_facility: Hospital Universitario Virgen del Rocío, Servicio de Neurología

location_facility: Institute of Psychiatry and Neurology, First Dept. of Neurology

location_facility: CHUV - Centre Hospitalier Universitaire Vaudois, Département de Neurologie

location_facility: University of Manchester, Genetic Medicine, St. Mary's Hospital

location_facility: Clinique Neurologique Hôpital Roger Salengro CHRU, Neurologie et Pathologie du Mouvement

location_facility: Hôpital Henri Mondor, Service de Neurologie

location_facility: Fakultní nemocnice Olomouc, Neurologická klinika

location_facility: St George's Hospital Medical School, South West Thames Regional Genetics Unit

location_facility: Universtität Erlangen, Abteilung für Molekulare Neurologie

location_facility: The Family Federation of Finland Väestöliitto, Department of Medical Genetics

location_facility: Bucknall Hospital, Neuropsychiatry Service

location_facility: Università Cattolica del Sacro Cuore "A.Gemelli", Istituto di Neurologia / CNR, Istituto di Farmacologia Traslazionale

location_facility: The Walton Centre for Neurology and Neurosurgery

location_facility: Charité - Universitätsmedizin Berlin, Klinik und Poliklinik für Neurologie, Klinik für Psychiatrie und Psychotherapie

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik für Neurologie

location_facility: Cardiff University, Life Sciences Building

location_facility: Specialistic Hospital in Gdansk, Dept. of Neurology

location_facility: Poole Hospital Foundation Trust, Brain Injury Service

location_facility: Medical University of Warsaw, Dept. of Neurology

location_facility: Leicestershire Partnership NHS Trust, EMD South School, OSL house

location_facility: CHU Rouen Charles Nicolle, Service de Neurologie

location_facility: The Barberry Centre, Dept. of Psychiatry

location_facility: Churchill Hospital, Dept. of Clinical Genetics

location_facility: Hospital Vall d'Hebrón, Neurología, 3ª planta, consultas externas

location_facility: University Hospital Zurich, Dept. of Neurology

location_facility: Azienda Ospedaliera Universitarie Pisana, Dip. di Neuroscienze - UO Neurologia

location_facility: Universitätsklinikum Hamburg-Eppendorf, Neurologische Abteilung

location_facility: Derriford Hospital, Dept. of Clinical Neuropsychology

location_facility: Sahlgren University Hospital, Dept. of Clinical Genetics

location_facility: National Hospital for Neurology and Neurosurgery, Dept. for Neurology

location_facility: Hospital Universitario Mutua de Terrassa, Neurologia - Investigación

location_facility: Complejo Hospitalario Universitario de Albacete, Neurología

location_facility: University Hospital of Ulm, Dept. of Neurology

location_facility: Universitätsklinik für Psychiatrie, Neuropsychiatrische Ambulanz

location_facility: Turku University Hospital, Dept. of Neurology

location_facility: Skåne Universitetssjukhus, Neurologiska kliniken

location_facility: Universitair Ziekenhuis Gasthuisberg, Dienst Neurologie

location_facility: CHU d'Angers, Service de Neurologie Charcot

location_facility: The Finnish Parkinson Association, Suvituuli

location_facility: CHU La Timone, Service de Neurologie (9e étage)

location_facility: Hospital La Fe, Consultas Externas de Neurología

location_facility: Università di Bologna, Dip. di Scienze Neurologiche - Clinica Neurologica

location_facility: Fondazione IRCCS Istituto Neruologico Carlo Besta, SOSD Genetics of Neurodegenerative and Metabolic Diseases

location_facility: Hôpital Purpan, INSERM U825, Pôle Neurosciences

location_facility: Medical University of Silesia, Dept. of Neurology

location_facility: Rikshospitalet, Dept. of Medical Genetics

location_facility: Ninewells Hospital and Medical School, Human Genetics Unit

location_facility: Sheffield Children's Hospital, Dept. of Clinical Genetics

location_facility: Institute of Pathology and Genetics (IPG)

location_facility: University of Bari, Dept. of Neurological and Psychiatric Sciences

location_facility: Medisch Spectrum Twente, Dept. of Neurology

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta, I Neurologia

location_facility: Clinical Genetics Centre, Ground Floor, Ashgrove House

location_facility: University of Florence, Dip. di Scienze Neurologiche e Psichiatriche

location_facility: NKS Olaviken Alderpsykiatriske sykehus, Poliklinikk og Huntington Klinikk

location_facility: Hospital Virgen del Camino, Medical Genetics

location_facility: Hospital dos Capuchos, Centro Hospitalar Lisboa Central, Neurology Dept.

location_facility: Norrlands Universitet Sjukhus, Dept. of Neurology

location_facility: Ålands Hälso- och Sjukvård, Långvårdsenheten

location_facility: Royal Devon and Exeter Foundation Trust Hospital, Department of Neurology

location_facility: Azienda Ospedaliera Spedali Civili di Brescia, Clinica Neurologica

location_facility: Hôpital Pellegrin, Service de Génétique Médicale (ESF 3e étage)

location_facility: The Royal Hospital for Neuro-disability, Research and Development

location_facility: Neurologische Klinik mit Klinischer Neurophysiologie, Medizinische Hochschule Hannover

location_facility: University Hospital of Copenhagen - Rigshospitalet, Dept. of Neurology

location_facility: Hospital Donostia. Universidad del Pais Vasco, Neurociencias

location_facility: Reha-Zentrum Dinslaken im Gesundheitszentrum Lang, Tagesklinik

location_facility: CHU d'Amiens - Hôpital Nord, Service de Neurologie

location_facility: Universitätsklinikum Münster, Klinik und Poliklinik für Neurologie

location_facility: Universitätsklinikum Aachen, Neurologische Klinik

location_facility: Hospital Clinico Universario, Department of Neurology

location_facility: HU Clermont-Ferrand - Hôpital Gabriel Montpied, Service de Neurologie

location_facility: Poznan University of Medical Sciences, Dept. of Social Medicine

location_facility: Cambridge Centre for Brain Repair, Forvie Site

location_facility: Southampton General Hospital and University of Southampton, Neurology / Wellcome Trust Clinical Research Facility

location_facility: Hospital Geral de Santo António, Neurology Dept.

location_facility: Università di Genova, Dept. of Neurosciences

location_facility: Institute of Human Genetics, International Centre for Life

location_facility: Hospital de Santa Maria, Centro de Estudos Egas Moniz, Neurology Dept.

location_facility: Ulleval University Hospital, Medical Genetics

location_facility: Neurologische Klinik des Inselspitals, Praxis

location_facility: Hospital Virgen de la Arrixaca, Neurology

location_facility: Oulu University Hospital (OUH), Dept. of Neurology

location_facility: Hospital Clínic i Provincial, Neurología

location_facility: Scottish Huntington Association, Units 105/106

location_facility: Hôpital La Pitié Salpétrière, Génétique & Inserm U679

location_facility: Hospital Clínico de Madrid, Servicio de Neurología

location_facility: Centro Hospitalar de Trás-os-Montes e Alto Douro, Neurology Dept.

location_facility: Molecular Medicine Centre, Western General Hospital, Dept. of Clinical Genetics


title: Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort

summary: Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 20,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Landwehrmeyer GB, Fitzer-Attas CJ, Giuliano JD, Goncalves N, Anderson KE, Cardoso F, Ferreira JJ, Mestre TA, Stout JC, Sampaio C. Data Analytics from Enroll-HD, a Global Clinical Research Platform for Huntington's Disease. Mov Disord Clin Pract. 2016 Jun 22;4(2):212-224. doi: 10.1002/mdc3.12388. eCollection 2017 Mar-Apr.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Monash University - Monash University Research Portal

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central;monash.edu

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

lead_sponsor: CHDI Foundation, Inc.

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Chile
Canada
France
Colombia
Portugal
Denmark
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Spain

location_facility: IRCCS Istituto delle Scienze Neurologiche di Bologna

location_facility: University of California - San Francisco

location_facility: Booth Gardner Parkinson's Care Center (Evergreen Health)

location_facility: University of Alberta Hospital in Edmonton

location_facility: Lille-Amiens - Huntington Disease Constituent site

location_facility: Institute of Psychiatry and Neurology, Warsaw

location_facility: University of Illinois College of Medicine at Rockford

location_facility: CHU Angers, Centre de Référence Maladies Neurogénétiques

location_facility: Universidad de Antioquia, Grupo de Neurociencias

location_facility: Hospital de Santa Maria / Instituto de Medicina Molecular

location_facility: Sheffield Children's NHS Foundation Trust

location_facility: Northumberland, Tyne & Wear NHS Foundation Trust of St. Nicholas Hospital

location_facility: Copernicus Podmiotem Leczniczym sp. z o.o.

location_facility: Guy's and St. Thomas's NHS Foundation Trust

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta - Neurology

location_facility: Hôpital Henri Mondor, Centre d'Investigation Clinique

location_facility: University Hospital Carl Gustav Carus Dresden

location_facility: Fundacion Clinic per a La Recerca Biomèdica

location_facility: Instituto de Neurociencias Buenos Aires (INEBA)

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Avon and Wiltshire Mental Health Partnership

location_facility: University of South Florida, HDSA Center of Excellence at USF

location_facility: Rutgers, the State University of New Jersey

location_facility: North Staffordshire Combined Healthcare NHS Trust

location_facility: New Zealand Brain Research Institute at University of Otago

location_facility: Royal Devon and Exeter NHS Foundation Trust

location_facility: University of Tennessee Health Science Center

location_facility: Hôpitaux Universitaires de Strasbourg Hôpital de Hautepierre-Service de Neurologie

location_facility: Central Manchester University Hospitals NHS Foundation Trust

location_facility: University of Calgary, Movement Disorders Program

location_facility: Virginia Commonwealth University Parkinson's and Movement Disorders Center

location_facility: University of California - Irvine Medical Center

location_facility: University of Maryland School of Medicine

location_facility: Bordeaux - Huntington Disease competencies center

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta - Genetics

location_facility: Emory University, Wesley Woods Health Center

location_facility: Institut de Pathologie et de Génétique (IPG)

location_facility: Institut du Cerveau et de la Moelle Epinière

location_facility: University of Melbourne, Royal Melbourne Hospital

location_facility: University of Texas Health Science Center

location_facility: The Neurosciences Unit - North Metropolitan Hospital

location_facility: Hôpital Purpan, Centre d'Investigation Clinique

location_facility: Università degli Studi di Genova (DINOGMI)

location_facility: Cenexel Rocky Mountain Clinical Research, LLC

location_facility: Birmingham and Solihull Mental Health NHS Foundation Trust

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: A Dolutegravir Open Label Protocol for HIV Infected, Adult and Adolescent Patients With Integrase Resistance

acronym: DEAP

summary: ING114916 is an open-label, multi-center, expanded access (EAP) study

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

ipd_sharing: Undecided

lead_sponsor: ViiV Healthcare

sponsor_collaborators:
ViiV Healthcare
GlaxoSmithKline

location_country:
Germany
Italy
Poland
Brazil
Austria
Belgium
United States
Canada
France

intervention_type: Drug

status_simplified: Completed


title: A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg Versus at 10 mg /kg in Subjects With Previously Treated or Untreated Unresectable or Metastatic Melanoma

summary: The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg

design_allocation: Randomized

enrollment_type: Actual

ReferenceCitation: Ascierto PA, Del Vecchio M, Mackiewicz A, Robert C, Chiarion-Sileni V, Arance A, Lebbe C, Svane IM, McNeil C, Rutkowski P, Loquai C, Mortier L, Hamid O, Bastholt L, Dreno B, Schadendorf D, Garbe C, Nyakas M, Grob JJ, Thomas L, Liszkay G, Smylie M, Hoeller C, Ferraresi V, Grange F, Gutzmer R, Pikiel J, Hosein F, Simsek B, Maio M. Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma. J Immunother Cancer. 2020 Jun;8(1):e000391. doi: 10.1136/jitc-2019-000391. Erratum In: J Immunother Cancer. 2020 Jul;8(2):

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

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

repository_normalized: HAL

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central;sdu.dk;usiena-air.unisi.it

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

ReferenceCitation: Feng Y, Wang X, Suryawanshi S, Bello A, Roy A. Linking Tumor Growth Dynamics to Survival in Ipilimumab-Treated Patients With Advanced Melanoma Using Mixture Tumor Growth Dynamic Modeling. CPT Pharmacometrics Syst Pharmacol. 2019 Nov;8(11):825-834. doi: 10.1002/psp4.12454. Epub 2019 Aug 13.

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

ReferenceCitation: Ascierto PA, Del Vecchio M, Robert C, Mackiewicz A, Chiarion-Sileni V, Arance A, Lebbe C, Bastholt L, Hamid O, Rutkowski P, McNeil C, Garbe C, Loquai C, Dreno B, Thomas L, Grob JJ, Liszkay G, Nyakas M, Gutzmer R, Pikiel J, Grange F, Hoeller C, Ferraresi V, Smylie M, Schadendorf D, Mortier L, Svane IM, Hennicken D, Qureshi A, Maio M. Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2017 May;18(5):611-622. doi: 10.1016/S1470-2045(17)30231-0. Epub 2017 Mar 27.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Poland
Argentina
Australia
Czechia
Canada
France
Hungary
Denmark
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
South Africa
Israel

location_facility: St. Luke's Cancer Center - Anderson Campus

location_facility: The Angeles Clinic And Research Institute

intervention_type: Biological


title: A Multi-centre, Multinational, Open-labelled, Randomised, Parallel-Group Comparison of Insulin Detemir Plus Insulin Aspart With NPH Insulin Plus Human Soluble Insulin in Subjects With Type 1 Diabetes on a Basal-Bolus Regimen

summary: This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.

ReferenceType: result

ReferenceCitation: Hermansen K, Fontaine P, Kukolja KK, Peterkova V, Leth G, Gall MA. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes. Diabetologia. 2004 Apr;47(4):622-9. doi: 10.1007/s00125-004-1365-z.

lead_sponsor: Novo Nordisk A/S

location_country: Macedonia, The Former Yugoslav Republic of


title: An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects With Multiple Sclerosis

acronym: ENABLE

summary: The primary objective of the study is to assess the effect of long-term treatment with prolonged-release fampridine (BIIB041) 10 mg twice daily on the physical component scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) as reported by treatment responders. The secondary objectives of this study are to compare the change in the PCS of the SF-36 between treatment responders and non-responders, to evaluate change from baseline in additional quality of life measures among treatment responders as well as changes from baseline in treatment responders versus non-responders and to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily.

ReferenceType: background

ReferenceCitation: Macdonell R, Nagels G, Laplaud DA, Pozzilli C, de Jong B, Martins da Silva A, Nicholas R, Lechner-Scott J, Gaebler JA, Agarwal S, Wang P, Yeh M, Hovenden M, Soelberg Sorensen P. Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine. Mult Scler. 2016 Jun;22(7):944-54. doi: 10.1177/1352458515606809. Epub 2015 Oct 7.

lead_sponsor: Biogen

location_country:
Germany
Italy
Portugal
United Kingdom
Denmark
Australia
Netherlands
Belgium
France


type: Other Identifier

title: A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Onartuzumab (Metmab) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Standard Chemotherapy for Advanced/Metastatic Disease

summary: This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb) or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

ReferenceCitation: Koeppen H, Yu W, Zha J, Pandita A, Penuel E, Rangell L, Raja R, Mohan S, Patel R, Desai R, Fu L, Do A, Parab V, Xia X, Januario T, Louie SG, Filvaroff E, Shames DS, Wistuba I, Lipkind M, Huang J, Lazarov M, Ramakrishnan V, Amler L, Phan SC, Patel P, Peterson A, Yauch RL. Biomarker analyses from a placebo-controlled phase II study evaluating erlotinib+/-onartuzumab in advanced non-small cell lung cancer: MET expression levels are predictive of patient benefit. Clin Cancer Res. 2014 Sep 1;20(17):4488-98. doi: 10.1158/1078-0432.CCR-13-1836. Epub 2014 Mar 31.

evidence: open (via free pdf)

version: acceptedVersion

evidence: oa repository (via page says license)

version: submittedVersion

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Genentech, Inc.

sponsor_collaborators:
Genentech, Inc.
Hoffmann-La Roche

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Croatia
Chile
Canada
Serbia
France
Hungary
Hong Kong
United States
Ukraine
Belgium
Peru
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel


title: A Randomized, Multi-Center Cross-Over Study to Evaluate Patient Preference and Health Care Professional (HCP) Satisfaction With Subcutaneous (SC) Administration of Trastuzumab in HER2-Positive Early Breast Cancer (EBC)

acronym: PrefHER

summary: This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early breast cancer. Participants will be randomized to receive either SC Herceptin or IV Herceptin every 3 weeks for Cycles 1 to 4, followed by crossover to the other treatment administration for Cycles 5 to 8. For up to 10 additional cycles (for a total of 18 cycles), participants will receive IV or SC Herceptin every 3 weeks.

primary_purpose: Health Services Research

ReferenceCitation: Pivot X, Verma S, Fallowfield L, Muller V, Lichinitser M, Jenkins V, Sanchez Munoz A, Machackova Z, Osborne S, Gligorov J; PrefHer Study Group. Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: Final analysis of the randomised, two-cohort PrefHer study. Eur J Cancer. 2017 Nov;86:82-90. doi: 10.1016/j.ejca.2017.08.019. Epub 2017 Sep 28.

oa_host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Sussex - Sussex Research Online

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

repository_institution: University of Illinois at Chicago - INDIGO

unpaywall_oa_status: green

ReferenceCitation: Gligorov J, Curigliano G, Muller V, Knoop A, Jenkins V, Verma S, Osborne S, Lauer S, Machackova Z, Fallowfield L, Pivot X. Switching between intravenous and subcutaneous trastuzumab: Safety results from the PrefHer trial. Breast. 2017 Aug;34:89-95. doi: 10.1016/j.breast.2017.05.004. Epub 2017 May 23.

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

ReferenceCitation: De Cock E, Pivot X, Hauser N, Verma S, Kritikou P, Millar D, Knoop A. A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Med. 2016 Mar;5(3):389-97. doi: 10.1002/cam4.573. Epub 2016 Jan 25.

ReferenceCitation: Pivot X, Gligorov J, Muller V, Curigliano G, Knoop A, Verma S, Jenkins V, Scotto N, Osborne S, Fallowfield L; PrefHer Study Group. Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study. Ann Oncol. 2014 Oct;25(10):1979-1987. doi: 10.1093/annonc/mdu364. Epub 2014 Jul 28.

oa_colors: green hybrid

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: reroDoc Digital Library

unpaywall_oa_status: hybrid

ReferenceCitation: Pivot X, Gligorov J, Muller V, Barrett-Lee P, Verma S, Knoop A, Curigliano G, Semiglazov V, Lopez-Vivanco G, Jenkins V, Scotto N, Osborne S, Fallowfield L; PrefHer Study Group. Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study. Lancet Oncol. 2013 Sep;14(10):962-70. doi: 10.1016/S1470-2045(13)70383-8. Epub 2013 Aug 19.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Sweden
Switzerland
Spain
Turkey
Canada
Russian Federation
France


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)

summary: This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or could not tolerate at least one TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or certolizumab pegol).

ReferenceCitation: Adedokun OJ, Xu Z, Gasink C, Kowalski K, Sandborn WJ, Feagan B. Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease. Clin Ther. 2022 Oct;44(10):1336-1355. doi: 10.1016/j.clinthera.2022.08.010. Epub 2022 Sep 21.

oa_host_type: publisher

ReferenceCitation: Narula N, Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W. Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease. Am J Gastroenterol. 2022 Jul 1;117(7):1106-1117. doi: 10.14309/ajg.0000000000001795. Epub 2022 Apr 15.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Narula N, Aruljothy A, Wong ECL, Homenauth R, Alshahrani AA, Marshall JK, Reinisch W. The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies. United European Gastroenterol J. 2021 Jun;9(5):581-589. doi: 10.1002/ueg2.12094. Epub 2021 Jun 2.

ReferenceCitation: Sandborn WJ, Feagan BG, Danese S, O'Brien CD, Ott E, Marano C, Baker T, Zhou Y, Volger S, Tikhonov I, Gasink C, Sands BE, Ghosh S. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):994-1007. doi: 10.1093/ibd/izaa236. Erratum In: Inflamm Bowel Dis. 2021 Jun 15;27(7):1175.

publisher_dissemination: Oxford University Press

ReferenceCitation: Li K, Friedman JR, Chan D, Pollack P, Yang F, Jacobstein D, Brodmerkel C, Gasink C, Feagan BG, Sandborn WJ, Rutgeerts P, De Hertogh G. Effects of Ustekinumab on Histologic Disease Activity in Patients With Crohn's Disease. Gastroenterology. 2019 Oct;157(4):1019-1031.e7. doi: 10.1053/j.gastro.2019.06.037. Epub 2019 Jul 4.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven)

ReferenceCitation: Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum In: Drug Saf. 2019 Apr 22;:

evidence: open (via page says license)

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repository_institution: University of California - eScholarship University of California

repositories:
PubMed Central
Pure (Denmark)
escholarship.org

ReferenceCitation: Rutgeerts P, Gasink C, Chan D, Lang Y, Pollack P, Colombel JF, Wolf DC, Jacobstein D, Johanns J, Szapary P, Adedokun OJ, Feagan BG, Sandborn WJ. Efficacy of Ustekinumab for Inducing Endoscopic Healing in Patients With Crohn's Disease. Gastroenterology. 2018 Oct;155(4):1045-1058. doi: 10.1053/j.gastro.2018.06.035. Epub 2018 Aug 29.

ReferenceCitation: Adedokun OJ, Xu Z, Gasink C, Jacobstein D, Szapary P, Johanns J, Gao LL, Davis HM, Hanauer SB, Feagan BG, Ghosh S, Sandborn WJ. Pharmacokinetics and Exposure Response Relationships of Ustekinumab in Patients With Crohn's Disease. Gastroenterology. 2018 May;154(6):1660-1671. doi: 10.1053/j.gastro.2018.01.043. Epub 2018 Feb 1.

ReferenceCitation: Hibi T, Imai Y, Murata Y, Matsushima N, Zheng R, Gasink C. Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies. Intest Res. 2017 Oct;15(4):475-486. doi: 10.5217/ir.2017.15.4.475. Epub 2017 Oct 23.

publisher_dissemination: Korean Association for the Study of Intestinal Diseases

ReferenceCitation: Feagan BG, Sandborn WJ, Gasink C, Jacobstein D, Lang Y, Friedman JR, Blank MA, Johanns J, Gao LL, Miao Y, Adedokun OJ, Sands BE, Hanauer SB, Vermeire S, Targan S, Ghosh S, de Villiers WJ, Colombel JF, Tulassay Z, Seidler U, Salzberg BA, Desreumaux P, Lee SD, Loftus EV Jr, Dieleman LA, Katz S, Rutgeerts P; UNITI-IM-UNITI Study Group. Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2016 Nov 17;375(20):1946-1960. doi: 10.1056/NEJMoa1602773.

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

repository_institution: St George's University of London - St George's Online Research Archive

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Brazil
Japan
Canada
Serbia
France
Czech Republic
Hungary
Denmark
United States
Iceland
Belgium
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Israel


title: A Single Arm, Open-label, Phase II, Multicentre Study, to Assess the Safety of Vismodegib (GDC-0449) in Patient With Locally Advanced or Metastatic Basal Cell Carcinoma (BCC)

summary: This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity.

ReferenceCitation: Bossi P, Peris K, Calzavara-Pinton P, Queirolo P, Alfieri S, Palla M, Rossi MT, Spagnolo F, Tambone S, Astolfi C, Ascierto PA. Cohort analysis of safety and efficacy of vismodegib in Italian patients from the Phase II, multicenter STEVIE study. Future Oncol. 2020 Jun;16(16):1091-1100. doi: 10.2217/fon-2019-0664. Epub 2020 May 6.

publisher_dissemination: Future Science Ltd

ReferenceCitation: Basset-Seguin N, Hauschild A, Kunstfeld R, Grob J, Dreno B, Mortier L, Ascierto PA, Licitra L, Dutriaux C, Thomas L, Meyer N, Guillot B, Dummer R, Arenberger P, Fife K, Raimundo A, Dika E, Dimier N, Fittipaldo A, Xynos I, Hansson J. Vismodegib in patients with advanced basal cell carcinoma: Primary analysis of STEVIE, an international, open-label trial. Eur J Cancer. 2017 Nov;86:334-348. doi: 10.1016/j.ejca.2017.08.022. Epub 2017 Nov 5.

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Mines Nantes

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

ReferenceCitation: Basset-Seguin N, Hauschild A, Grob JJ, Kunstfeld R, Dreno B, Mortier L, Ascierto PA, Licitra L, Dutriaux C, Thomas L, Jouary T, Meyer N, Guillot B, Dummer R, Fife K, Ernst DS, Williams S, Fittipaldo A, Xynos I, Hansson J. Vismodegib in patients with advanced basal cell carcinoma (STEVIE): a pre-planned interim analysis of an international, open-label trial. Lancet Oncol. 2015 Jun;16(6):729-36. doi: 10.1016/S1470-2045(15)70198-1. Epub 2015 May 13.

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Bosnia and Herzegovina
Turkey
Croatia
Czechia
Canada
Serbia
France
Slovenia
Lithuania
Colombia
Portugal
Slovakia
Hungary
Denmark
Switzerland
Romania
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
Bulgaria
Russian Federation
Israel

location_facility: Klinikum d.Stadt Ludwigshafen Hautklinik

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Dermatologia

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna

location_facility: LKH Salzburg; Universitätsklinik für Dermatologie

location_facility: Università di Brescia; Dipartimento di Dermatologia

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Academ Ziekenhuis Groningen; Medical Oncology

location_facility: Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Dermatologie und Allergologie

location_facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin"

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Istituto Dermatologico San Gallicano IRCCS; Dermatologia Oncolgica

location_facility: A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Andreas Syggros Hospital; 1st University Dermatology Clinic; Oncology Department

location_facility: Centre de Recherche Dermatologique du Quebec Metropolitain (CRDQ)

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica

location_facility: Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie

location_facility: Policlinico Sant'Orsola Malpighi; U.O. Dermatologia

location_facility: District Oncology Dispensary; Department for Oncology and Dermatology

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie

location_facility: Maastricht University Medical Centre; Dermatologie

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: S.C. Life Search S.R.L; Medical Oncology Clinic

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Hospital General Universitario de Guadalajara; Servicio de Dermatologia

location_facility: CMAX A division of IDT Australia Limited

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

location_facility: Waitemata District Health; General Surgery

location_facility: Helsinki University Central Hospital; Skin & Allergy Hospital

location_facility: Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: Klinikum Dortmund gGmbH Klinikzentrum Mitte

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Fundacion Hospital de Alcorcon; Servicio de Dermatologia

location_facility: Elbekliniken Buxtehude; Klinik für Dermatologie

location_facility: Harzklinikum Dorothea Christiane Erxleben GmbH; Klinik für Dermatologie und Allergologie

location_facility: Universitätsklinikum Münster; Klinik für Hautkrankheiten; Allgemeine Dermatologie und Venerologie

location_facility: A.O.U. Senese Policlinico Santa Maria Alle Scotte

location_facility: IRCCS Istituto Clinico Humanitas; Farmacia

location_facility: Laiko General Hospital; 1St Pathological Clinic

location_facility: St Vincent'S Uni Hospital; Medical Oncology

location_facility: Universitätsklinikum Marburg Klinik f. Dermatologie

location_facility: Hospital Universitario Virgen de las Nieves; Servicio de Oncologia

location_facility: Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo

location_facility: Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Inst. de Oncologia Angel H. Roffo ; Servicio de Oncologia

location_facility: Istanbul Uni of Medicine Faculty; Oncology Dept

location_facility: Hôpital Larrey Université Paul Sabatier; Service Dermatologie

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: Centre Hospitalier Lyon Sud; Dermatologie

location_facility: Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Klinik f.Dermatologie

location_facility: I.R.S.T. Srl - Meldola - FC; Day Hospital Oncologico

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: LKH Graz; Abteilung für allgemeine Dermatologie

location_facility: Cork University Hospital; Dermatology Dept

location_facility: Ankara Numune Training and Research Hospital; Dermatology

location_facility: Inst. Nacional de Cancerologia; Clinica de Seno

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Moscow city oncology hospital #62 of Moscow Healthcare Department

location_facility: UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie

location_facility: Dokuz Eylul University Medicine Faculty; Dermatology

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

location_facility: Hospital Clinic i Provincial; Servicio de dermatología

location_facility: Hospital Universitario Miguel Servet; Servicio Dermatologia

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia

location_facility: Charité Campus Mitte; Hauttumorcentrum Charité (HTCC); Klinik für Dermatologie, Venerologie und Alle

location_facility: Freeman Hospital; Northern Centre For Cancer Care

location_facility: HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie

location_facility: Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie

location_facility: Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol

location_facility: Fondazione Ptv Policlinico Tor Vergata; Dermatologia

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279

location_facility: Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika

location_facility: Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF

location_facility: Clinica Universitaria de Navarra; Servicio de Dermatologia

location_facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Dermatologia

location_facility: Hopital Saint Andre CHU De Bordeaux; Dermatologie

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: Universitätsspital Zürich; Dermatologische Klinik

location_facility: Hospital Reina Sofia; Servicio de dermatología

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Dermatologia

location_facility: Azienda Ospedaliera Umberto I; Clinica Dermatologica

location_facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique

location_facility: Gazi Universitesi Tip Facultesi; Dept. of Dermatology

location_facility: Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

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

location_facility: Uni Schleswig-Holstein; Klinik für Dermatologie, Allergologie und Venerologie (Hautklinik)

location_facility: Fakultní nemocnice Ostrava; Kožní oddělení

location_facility: Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti

location_facility: Universitätsmedizin Greifswald; Klinik für MKG-Chirurgie und Plastische Operationen

location_facility: Skånes Onkologiska Klinik, Universitetssjukhuset

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Medizinische Universität Wien; Univ.Klinik für Dermatologie

location_facility: Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika

location_facility: Hospital Univ. Central de Asturias; Servicio de Dermatologia

location_facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Dermatologia

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Institute for Oncology and Radiology of Serbia; Medical Oncology

location_facility: Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni

location_facility: Hospital Universitario del Sureste; Servicio de Dermatologia

location_facility: Western Infirmary; Division of Cardiovascular and Medical Sciences

location_facility: University General Hospital of loannina; Dermatology and Venereal Diseases Clinic


acronym: PROSELICA

lead_sponsor: Sanofi

summary:
Primary Objective:

- To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20 mg/m² (Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in participants with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen.

Secondary Objectives:

To evaluate safety in the 2 treatment arms and to assess if Cabazitaxel 20 mg/m² was better tolerated than Cabazitaxel 25 mg/m².

To compare efficacy of Cabazitaxel at 20 mg/m² and 25 mg/m² for:

Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST), prostate-specific antigen (PSA) progression, pain progression or death due to any cause;
PSA Progression;
Pain progression;
Tumor response in participants with measurable disease (RECIST 1.1);
PSA response;
Pain response in participants with stable pain at baseline.
To compare Health-related Quality of Life (HRQoL).
To assess the pharmacokinetics and pharmacogenomics of Cabazitaxel.

ReferenceCitation: Meisel A, de Wit R, Oudard S, Sartor O, Stenner-Liewen F, Shun Z, Foster M, Ozatilgan A, Eisenberger M, de Bono JS. Neutropenia, neutrophilia, and neutrophil-lymphocyte ratio as prognostic markers in patients with metastatic castration-resistant prostate cancer. Ther Adv Med Oncol. 2022 Jun 1;14:17588359221100022. doi: 10.1177/17588359221100022. eCollection 2022.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: ETH Zurich - Repository for Publications and Research Data

publisher_dissemination: SAGE Publications

ReferenceCitation: Thiery-Vuillemin A, Fizazi K, Sartor O, Oudard S, Bury D, Thangavelu K, Ozatilgan A, Poole EM, Eisenberger M, de Bono J. An analysis of health-related quality of life in the phase III PROSELICA and FIRSTANA studies assessing cabazitaxel in patients with metastatic castration-resistant prostate cancer. ESMO Open. 2021 Apr;6(2):100089. doi: 10.1016/j.esmoop.2021.100089. Epub 2021 Mar 16.

ReferenceCitation: Mehra N, Dolling D, Sumanasuriya S, Christova R, Pope L, Carreira S, Seed G, Yuan W, Goodall J, Hall E, Flohr P, Boysen G, Bianchini D, Sartor O, Eisenberger MA, Fizazi K, Oudard S, Chadjaa M, Mace S, de Bono JS. Plasma Cell-free DNA Concentration and Outcomes from Taxane Therapy in Metastatic Castration-resistant Prostate Cancer from Two Phase III Trials (FIRSTANA and PROSELICA). Eur Urol. 2018 Sep;74(3):283-291. doi: 10.1016/j.eururo.2018.02.013. Epub 2018 Feb 28.

repository_institution: PubMed Central - Europe PMC

repository_institution: Radboud University - Radboud Repository

repositories_concat: PubMed Central;repository.ubn.ru.nl

repositories_institution:
PubMed Central - Europe PMC
Radboud University - Radboud Repository

ReferenceCitation: Eisenberger M, Hardy-Bessard AC, Kim CS, Geczi L, Ford D, Mourey L, Carles J, Parente P, Font A, Kacso G, Chadjaa M, Zhang W, Bernard J, de Bono J. Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m2) and the Currently Approved Dose (25 mg/m2) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer-PROSELICA. J Clin Oncol. 2017 Oct 1;35(28):3198-3206. doi: 10.1200/JCO.2016.72.1076. Epub 2017 Aug 15.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Winquist E, Rodrigues G. Open clinical uro-oncology trials in Canada. Can J Urol. 2012 Dec;19(6):6587-91. No abstract available.

location_facility:
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title: Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen

source: euctr

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Chile
Canada
France
Hungary
United States
Romania
Tunisia
Belgium
Peru
United Kingdom
Netherlands
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation


title: A Randomized, Double Blind Study of the Safety and Efficacy of GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily Both Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

summary: The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult subjects.

ReferenceCitation: Brinson C, Walmsley S, Arasteh K, et al. Dolutegravir treatment response and safety by key subgroups in treatment naive HIV-infected individuals. Published at: Conference on Retroviruses and Opportunistic Infections - 20th Annual; March 3-6, 2013; Atlanta, GA.

ReferenceCitation: Raffi F, Rachlis A, Stellbrink HJ, Hardy WD, Torti C, Orkin C, Bloch M, Podzamczer D, Pokrovsky V, Pulido F, Almond S, Margolis D, Brennan C, Min S; SPRING-2 Study Group. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013 Mar 2;381(9868):735-43. doi: 10.1016/S0140-6736(12)61853-4. Epub 2013 Jan 8.

ReferenceCitation: Raffi F, Jaeger H, Quiros-Roldan E, Albrecht H, Belonosova E, Gatell JM, Baril JG, Domingo P, Brennan C, Almond S, Min S; extended SPRING-2 Study Group. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2013 Nov;13(11):927-35. doi: 10.1016/S1473-3099(13)70257-3. Epub 2013 Sep 25.

collaborators: Shionogi GlaxoSmithKline

sponsor_collaborators:
ViiV Healthcare
Shionogi
GlaxoSmithKline

location_country:
Germany
Italy
United Kingdom
Australia
United States
Spain
Canada
Russian Federation
France


title: A Randomized, Double-blind Study of the Effect of Avastin Plus Gemcitabine and Erlotinib Compared With Placebo Plus Gemcitabine and Erlotinib on Overall Survival in Patients With Metastatic Pancreatic Cancer

summary: This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals.

location_country:
Finland
Germany
Poland
New Zealand
Australia
Canada
France
Czech Republic
Belgium
China
Peru
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Spain
South Africa
Taiwan
Israel


title: A MULTICENTER, GLOBAL, RANDOMIZED, DOUBLE-BLIND STUDY OF AXITINIB PLUS BEST SUPPORTIVE CARE VERSUS PLACEBO PLUS BEST SUPPORTIVE CARE IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA FOLLOWING FAILURE OF ONE PRIOR ANTIANGIOGENIC THERAPY

summary: The study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma.

ReferenceCitation: Kang YK, Yau T, Park JW, Lim HY, Lee TY, Obi S, Chan SL, Qin S, Kim RD, Casey M, Chen C, Bhattacharyya H, Williams JA, Valota O, Chakrabarti D, Kudo M. Randomized phase II study of axitinib versus placebo plus best supportive care in second-line treatment of advanced hepatocellular carcinoma. Ann Oncol. 2015 Dec;26(12):2457-63. doi: 10.1093/annonc/mdv388. Epub 2015 Sep 18.

ipd_sharing: Yes

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Germany
Italy
Slovakia
Hungary
Hong Kong
United Kingdom
Japan
Belgium
United States
China
Korea, Republic of
Taiwan
France

location_facility: Klinikum der Ludwig-Maximilians-Universitaet , Campus Grosshadern

location_facility: Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University

location_facility: Aichi Cancer Center Central Hospital, Diagnostic and Interventional Radiology

location_facility: University of California Irvine Medical Center

location_facility: Szegedi Tudományegyetem Onkoterápiás Klinika

location_facility: Clatterbridge Centre for Oncology NHS Foundation Trust

location_facility: Unita Operativa Oncologia Medica IRCCS Fondazione Salvatore Maugeri

location_facility: National Cancer Center/ Center for Liver Cancer

location_facility: Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Moffitt Cancer Center & Research Institute

location_facility: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori IRST

location_facility: Policlinico Universitario Agostino Gemelli

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

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria aile Scotte

location_facility: Hospital of the University of Pennsylvania

location_facility: Bichat-Beaujon Service Inter Hospitalier De Cancerologie

location_facility: Asan Medical Center, Division of Oncology, Department of Internal Medicine

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Istituto di Ematologia ed Oncologia Medica, Lorenzo ed Ariosto Seragnoli,

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: Semmelweis Egyetem I.sz. Belgyógyászati Klinika

location_facility: Royal Liverpool and Broadgreen University Hospital

location_facility: CHRU Montpellier-Hopital Saint Eloi - Departement Oncologie Medicale

location_facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica

location_facility: Alta Bates Summit Comprehensive Cancer Center

location_facility: Policlinico S.Orsola-Malpighi Dipartimento di Ematologia e Scienze Oncologiche "L. E A. Seragnoli"

location_facility: Florida Hospital Transplant Center, Liver Unit


lead_sponsor: Celgene

summary: The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.

ReferenceCitation: Czuczman MS, Trneny M, Davies A, Rule S, Linton KM, Wagner-Johnston N, Gascoyne RD, Slack GW, Brousset P, Eberhard DA, Hernandez-Ilizaliturri FJ, Salles G, Witzig TE, Zinzani PL, Wright GW, Staudt LM, Yang Y, Williams PM, Lih CJ, Russo J, Thakurta A, Hagner P, Fustier P, Song D, Lewis ID. A Phase 2/3 Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Lenalidomide Versus Investigator's Choice in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma. Clin Cancer Res. 2017 Aug 1;23(15):4127-4137. doi: 10.1158/1078-0432.CCR-16-2818. Epub 2017 Apr 5.

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

repositories_concat: 1831cq68x;PubMed Central

ReferenceCitation: Hernandez-Ilizaliturri FJ, Deeb G, Zinzani PL, Pileri SA, Malik F, Macon WR, Goy A, Witzig TE, Czuczman MS. Higher response to lenalidomide in relapsed/refractory diffuse large B-cell lymphoma in nongerminal center B-cell-like than in germinal center B-cell-like phenotype. Cancer. 2011 Nov 15;117(22):5058-66. doi: 10.1002/cncr.26135. Epub 2011 Apr 14.

location_facility: Universita Federico II di Napoli Nuovo Policlinico

location_facility: Washington University Siteman Cancer Center

location_facility: CHU de Grenoble-Hopital Albert Michallon

location_facility: Royal Devon and Exeter Hospital Haematology Department

location_facility: Providence St Joseph Medical Center/Cancer Center

location_facility: Clinica Ematologica, A.O.U. San Martino di Genova

location_facility: Istituto di Ematologica Istituto di Ematologica " L.e. A. Seragnoli' Azienda Ospedaliera Universitaria Policlinico

location_facility: Hosptial Clinico Universitario de Salamanca

location_facility: The Christie Foundation Trust, I'st Floor, Haemotology Oncology Outpatients, Lymphoma Team

location_facility: Azienda Ospedaliera di Perugai Ospedale S. Maria della Miseri

location_facility: Southhampton University Hospital NHS Trust

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: University of Michigan, Comprehensive Cancer Center

location_facility: Policlinico Tor Vergata (Universta Tor Vergata)

location_facility: Royal Mardsen Hospital - Fulham (Satellite Site)

title: A Phase 2/3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Lenalidomide (Revlimid ®) Versus Investigator's Choice in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

location_country:
Italy
United Kingdom
Australia
Sweden
Austria
United States
Spain
Czechia
France


acronym: PREVENT

lead_sponsor: Janssen Biotech, Inc.

summary: REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in an experiment to see if it may be useful in preventing relapse of Crohn's disease after surgical resection. This study will compare the effects (both good and bad) of REMICADE (infliximab) to those of placebo. Placebo looks like the drug being studied but has no active ingredients.

ReferenceCitation: Regueiro M, Feagan BG, Zou B, Johanns J, Blank MA, Chevrier M, Plevy S, Popp J, Cornillie FJ, Lukas M, Danese S, Gionchetti P, Hanauer SB, Reinisch W, Sandborn WJ, Sorrentino D, Rutgeerts P; PREVENT Study Group. Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease After Ileocolonic Resection. Gastroenterology. 2016 Jun;150(7):1568-1578. doi: 10.1053/j.gastro.2016.02.072. Epub 2016 Mar 3.

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

repository_institution: University of Liège - Open Repository and Bibliography

repositories_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

status: Terminated

title: Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at Increased Risk of Recurrence

primary_purpose: Prevention

location_country:
France
Germany
Poland
New Zealand
Hungary
Israel
United Kingdom
Australia
Netherlands
Austria
Belgium
United States
Canada
Czech Republic

status_simplified: Unknown


title: AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

acronym: AMBITION

summary: The purpose of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first clinical failure event.

ReferenceCitation: Kuwana M, Blair C, Takahashi T, Langley J, Coghlan JG. Initial combination therapy of ambrisentan and tadalafil in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) in the modified intention-to-treat population of the AMBITION study: post hoc analysis. Ann Rheum Dis. 2020 May;79(5):626-634. doi: 10.1136/annrheumdis-2019-216274. Epub 2020 Mar 11. Erratum In: Ann Rheum Dis. 2020 Sep;79(9):e118.

ReferenceCitation: White RJ, Vonk-Noordegraaf A, Rosenkranz S, Oudiz RJ, McLaughlin VV, Hoeper MM, Grunig E, Ghofrani HA, Chakinala MM, Barbera JA, Blair C, Langley J, Frost AE. Clinical outcomes stratified by baseline functional class after initial combination therapy for pulmonary arterial hypertension. Respir Res. 2019 Sep 12;20(1):208. doi: 10.1186/s12931-019-1180-1.

repository_institution: University of Michigan - Deep Blue

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

repository_institution: Imperial College London - Spiral

publisher_dissemination: Springer-Nature

ReferenceCitation: Coghlan JG, Galie N, Barbera JA, Frost AE, Ghofrani HA, Hoeper MM, Kuwana M, McLaughlin VV, Peacock AJ, Simonneau G, Vachiery JL, Blair C, Gillies H, Miller KL, Harris JHN, Langley J, Rubin LJ; AMBITION investigators. Initial combination therapy with ambrisentan and tadalafil in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH): subgroup analysis from the AMBITION trial. Ann Rheum Dis. 2017 Jul;76(7):1219-1227. doi: 10.1136/annrheumdis-2016-210236. Epub 2016 Dec 30.

license: public-domain

license_normalized: public-domain

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Galie N, Barbera JA, Frost AE, Ghofrani HA, Hoeper MM, McLaughlin VV, Peacock AJ, Simonneau G, Vachiery JL, Grunig E, Oudiz RJ, Vonk-Noordegraaf A, White RJ, Blair C, Gillies H, Miller KL, Harris JH, Langley J, Rubin LJ; AMBITION Investigators. Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension. N Engl J Med. 2015 Aug 27;373(9):834-44. doi: 10.1056/NEJMoa1413687.

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

ReferenceCitation: Peacock AJ, Zamboni W, Vizza CD. Ambrisentan for the treatment of adults with pulmonary arterial hypertension: a review. Curr Med Res Opin. 2015;31(9):1793-807. doi: 10.1185/03007995.2015.1074890. Epub 2015 Aug 27.

location_country:
Germany
Italy
United Kingdom
Australia
Japan
Netherlands
Austria
Belgium
Sweden
United States
Spain
Greece
Canada
France


lead_sponsor: Gilead Sciences

summary:
The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults.

Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening.

ReferenceCitation: Gallant JE, Koenig E, Andrade-Villanueva J, Chetchotisakd P, DeJesus E, Antunes F, Arasteh K, Moyle G, Rizzardini G, Fehr J, Liu Y, Zhong L, Callebaut C, Szwarcberg J, Rhee MS, Cheng AK. Cobicistat versus ritonavir as a pharmacoenhancer of atazanavir plus emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV type 1-infected patients: week 48 results. J Infect Dis. 2013 Jul;208(1):32-9. doi: 10.1093/infdis/jit122. Epub 2013 Mar 26.

repository_institution: University of Zurich - Zurich Open Repository and Archive

repository_institution: reroDoc Digital Library

ReferenceCitation: Gallant JE, Koenig E, Andrade-Villanueva JF, Chetchotisakd P, DeJesus E, Antunes F, Arasteh K, Rizzardini G, Fehr J, Liu HC, Abram ME, Cao H, Szwarcberg J. Brief Report: Cobicistat Compared With Ritonavir as a Pharmacoenhancer for Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate: Week 144 Results. J Acquir Immune Defic Syndr. 2015 Jul 1;69(3):338-40. doi: 10.1097/QAI.0000000000000598.

ReferenceCitation: Gallant J, Moyle G, Berenguer J, Shalit P, Cao H, Liu YP, Myers J, Rosenblatt L, Yang L, Szwarcberg J. Atazanavir Plus Cobicistat: Week 48 and Week 144 Subgroup Analyses of a Phase 3, Randomized, Double-Blind, Active-Controlled Trial. Curr HIV Res. 2017;15(3):216-224. doi: 10.2174/1570162X14666161021102728.

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

evidence: oa repository (semantic scholar lookup)

repositories:
PubMed Central
dnet
pdfs.semanticscholar.org

publisher_dissemination: Bentham Science Publishers Ltd.

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Department of Infectious Diseases, Saint-Louis hospital

location_facility: HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University

location_facility: Tarrant County Infectious Disease Associates

location_facility: Kaiser Permanente Medical Center, Clinical Trials Unit

location_facility: Canadian Immunodeficiency Research Collaborative (CIRC) Inc.

location_facility: University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department

location_facility: Hopital Sainte Marguerite Service d'Immuno-Hématologie Clinique -CISIH

location_facility: Division of Infectious Diseases, Thomas Jefferson University

location_facility: East Carolina University, The Brody School of Medicine

location_facility: Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine

location_facility: Instituto De Pesquisa Clinica Evandro Chagas

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Ramathibodi Hospital, Mahidol University

location_facility: Instituto de Investigacion Clentifica del Sur

location_facility: Centre François Magendie, Hôpital du Haut Lévêque

location_facility: Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Division of Infectious Diseases and Hospital Hygiene; University Hospital of Zurich

location_facility: Brasilmed Assistencia Medica E Pesquisas

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: Infectious Disease Research Institute Inc.

location_facility: University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit

location_facility: Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital

location_facility: Serviço de Doenças Infecciosas, Hospital de São João

location_facility: Istituto Nazionale Malattie Infettive Lazzaro Spallanzani

location_facility: Service des Maladies Infectieuses, CHU de Caen

location_facility: Broward Health/Comprehensive Care Center

location_facility: University of Cologne, Department of Internal Medicine

location_facility: University of California, Davis Medical Center

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Community Research Initiative of New England

location_facility: Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg

location_facility: Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive

location_facility: La Playa Medical Group and Clinical Research

location_facility: University Health Network, Toronto General Hospital

location_facility: Immunodeficiency Service, McGill University Health Centre (MUHC) - Montreal Chest Institute

location_facility: Johns Hopkins University School of Medicine

location_facility: Instituto Dominicano de Estudios Virologicos - IDEV

location_facility: Southwest Infectious Disease Clinical Research, Inc.

location_facility: George Washington University Medical Faculty Associates

location_facility: Universitätsklinik für Infektiologie, Universitätsspital Bern

location_facility: Infektio Research GmbH / Infektiologikum Frankfurt

location_facility: Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales

location_facility: Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic

location_facility: Hopital Saint Antoine, Service De Maladies Infectieuses

title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

location_country:
Germany
Australia
Brazil
Thailand
Canada
France
Portugal
Denmark
Switzerland
United States
Dominican Republic
Belgium
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain


summary: To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.

ReferenceCitation: DeJesus E, Rockstroh JK, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Yale K, Szwarcberg J, White K, Cheng AK, Kearney BP; GS-236-0103 Study Team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet. 2012 Jun 30;379(9835):2429-2438. doi: 10.1016/S0140-6736(12)60918-0.

ReferenceCitation: Rockstroh JK, DeJesus E, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Plummer A, Abram M, Cheng AK, Fordyce MW, Szwarcberg J; GS-236-0103 Study Team. A randomized, double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus coformulated emtricitabine and tenofovir DF for initial treatment of HIV-1 infection: analysis of week 96 results. J Acquir Immune Defic Syndr. 2013 Apr 15;62(5):483-6. doi: 10.1097/QAI.0b013e318286415c.

ReferenceCitation: Clumeck N, Molina JM, Henry K, Gathe J, Rockstroh JK, DeJesus E, Wei X, White K, Fordyce MW, Rhee MS, Szwarcberg J; GS-236-0103 Study Team. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus emtricitabine/tenofovir DF for initial treatment of HIV-1 infection: analysis of week 144 results. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):e121-4. doi: 10.1097/QAI.0000000000000089. No abstract available.

location_facility: National Centre in HIV Epidemiology and Clinical Research (NCHECR), University of New South Wales

location_facility: Yale University HIV Clinical Trials Program

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Department of Infectious Diseases, Saint-Louis hospital

location_facility: Tarrant County Infectious Disease Associates

location_facility: Kaiser Permanente Medical Center, Clinical Trials Unit

location_facility: Canadian Immunodeficiency Research Collaborative (CIRC) Inc.

location_facility: University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department

location_facility: Garden State Infectious Diseases Associates, PA

location_facility: Division of Infectious Diseases, Thomas Jefferson University

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Centre Hospitalier Universitaire de Nice

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

location_facility: Dr. Joseph C. Gathe MD (Therapeutic Concepts, PA)

location_facility: Ramathibodi Hospital, Mahidol University

location_facility: STAR Health Care Center (SUNY Downstate)

location_facility: Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde

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

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Treasure Coast Infectious Disease Consultants

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: Erasmus MC, Internal Medicine, Section of Infectious Diseases

location_facility: Infectious Disease Research Institute Inc.

location_facility: University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit

location_facility: Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital

location_facility: Serviço de Doenças Infecciosas, Hospital de São João

location_facility: St. Mary's Hospital, London (Imperial College, London)

location_facility: Service des Maladies Infectieuses, CHU de Caen

location_facility: Broward Health/Comprehensive Care Center

location_facility: University of Cologne, Department of Internal Medicine

location_facility: University of California, Davis Medical Center

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

location_facility: Baystate Infectious Diseases Clinical Research

location_facility: Department of Dermatology, Division of Immunology, Allergy & Inf. Diseases; Medical University Vienna

location_facility: Division of Infectious Diseases, St. Louis University Medical Center

location_facility: Nicholaos C. Bellos, MD, PA (Southwest Infectious Disease Clinical Research, Inc.)

location_facility: Chelsea and Westminster Hospital Foundation Trust

location_facility: CHU Gui de Chauliac, Maladies Infectieuses Dpt

location_facility: Melbourne Health - Royal Melbourne Hospital Campus (Sexual Health Clinic)

location_facility: Trinity Health and Wellness Center/AIDS Arms, Inc.

location_facility: Klinikum der Goethe-Universitaet, Medizinische Klinik II, Schwerpunkt HIV, Haus 68

title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

location_country:
Germany
Italy
Portugal
United Kingdom
Denmark
Australia
Sweden
Netherlands
Austria
Belgium
Mexico
United States
Switzerland
Thailand
Canada
Puerto Rico
France


title: SCOT Registry: Small Cell Lung Cancer Treatment and Outcome

acronym: SCOT

summary:
The registry is an international, multicenter, observational registry of newly diagnosed patients with SCLC.

Data will be entered into an electronic CRF (eCRF) via Internet access. Treatment plan remains the responsibility of the patient's physician and data collected in this registry will reflect a "real world" approach of the diagnosis and treatment of patients with SCLC.

Approximately 60 centres in 13 countries will take part in this registry. It is expected that about 500 patients will be recruited during a period of 6 to 9 months according to the feasibility.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Lithuania
Poland
Slovenia
Hungary
Netherlands
Austria
Korea, Republic of
Spain
Greece
Estonia
Czech Republic
France