title: Evaluation of Clinical Outcomes of Patients Undergoing a Redo-TAVI Procedure; a Multicenter Prospective Observational Registry

summary:
Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger & lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure.

The evidence on redo-TAVI (where a transcatheter heart valve [THV] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations.

Aim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year.

ReferenceCitation: VARC-3 WRITING COMMITTEE; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021 May 14;42(19):1825-1857. doi: 10.1093/eurheartj/ehaa799.

ReferenceCitation: Tarantini G, Delgado V, de Backer O, Sathananthan J, Treede H, Saia F, Blackman D, Parma R. Redo-Transcatheter Aortic Valve Implantation Using the SAPIEN 3/Ultra Transcatheter Heart Valves-Expert Consensus on Procedural Planning and Techniques. Am J Cardiol. 2023 Apr 1;192:228-244. doi: 10.1016/j.amjcard.2023.01.010. Epub 2023 Jan 27.

ReferenceCitation: Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

ReferenceCitation: Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.

ReferenceCitation: Toggweiler S, Wood DA, Rodes-Cabau J, Kapadia S, Willson AB, Ye J, Cheung A, Leipsic J, Binder RK, Gurvitch R, Freeman M, Thompson CR, Svensson LG, Dumont E, Tuzcu EM, Webb JG. Transcatheter valve-in-valve implantation for failed balloon-expandable transcatheter aortic valves. JACC Cardiovasc Interv. 2012 May;5(5):571-577. doi: 10.1016/j.jcin.2012.03.008.

ReferenceCitation: Kamioka N, Caughron H, Corrigan F, Block P, Babaliaros V. Supra-annular valve strategy for an early degenerated transcatheter balloon-expandable heart valve. Catheter Cardiovasc Interv. 2018 Dec 1;92(7):1458-1460. doi: 10.1002/ccd.27506. Epub 2018 Jan 23.

ReferenceCitation: Webb JG, Mack MJ, White JM, Dvir D, Blanke P, Herrmann HC, Leipsic J, Kodali SK, Makkar R, Miller DC, Pibarot P, Pichard A, Satler LF, Svensson L, Alu MC, Suri RM, Leon MB. Transcatheter Aortic Valve Implantation Within Degenerated Aortic Surgical Bioprostheses: PARTNER 2 Valve-in-Valve Registry. J Am Coll Cardiol. 2017 May 9;69(18):2253-2262. doi: 10.1016/j.jacc.2017.02.057.

ReferenceCitation: Deeb GM, Chetcuti SJ, Reardon MJ, Patel HJ, Grossman PM, Schreiber T, Forrest JK, Bajwa TK, O'Hair DP, Petrossian G, Robinson N, Katz S, Hartman A, Dauerman HL, Schmoker J, Khabbaz K, Watson DR, Yakubov SJ, Oh JK, Li S, Kleiman NS, Adams DH, Popma JJ. 1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses. JACC Cardiovasc Interv. 2017 May 22;10(10):1034-1044. doi: 10.1016/j.jcin.2017.03.018.

ReferenceCitation: Kopp-Schneider A, Wiesenfarth M, Witt R, Edelmann D, Witt O, Abel U. Monitoring futility and efficacy in phase II trials with Bayesian posterior distributions-A calibration approach. Biom J. 2019 May;61(3):488-502. doi: 10.1002/bimj.201700209. Epub 2018 Sep 2.

ipd_sharing_description: no individual participant data (IPD) will be shared

lead_sponsor: Institut für Pharmakologie und Präventive Medizin

location_country:
Germany
France
Italy
Poland
Portugal
United Kingdom
Netherlands
Austria
Switzerland
Spain
Canada
Israel

location_facility: Hôpitaux Universitaires de Marseille Timone

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Hospital de Santa Cruz, Carnaxide-Lisabon

location_facility: Trillium Health Partners Mississauga Hospital

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: LKH-University Hospital and Medical University of Graz

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Hospital Clínico Universitario de Santiago

location_facility: Heart and Diabetes Center North Rhine-Westphalia

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Institut Universitaire de Cardiologie et de Pneumologie

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Hospital University Germans Trias i Pujol

location_facility: Centre hospitalier universitaire vaudois et Université de Lausanne

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Centre hospitalier universitaire de Rennes

location_facility: Policlinici universitari | Sapienza Università di Roma

location_facility: Karte von Centro Hospitalar Vila Nova de Gaia / Espinho - Unit 1 Von außen ansehen Centro Hospitalar Vila Nova de Gaia / Espinho

location_facility: Azienda Ospedale-Università Padova (AOUP)

location_facility: IRCCS Azienda Ospedaliero Universitaria di Bologna

location_facility: Hospital Universitario Central de Asturias

location_facility: AOU Ospedali Riuniti Ancona, Umberto I, G. M. Lancisi, G. Salesi

location_facility: University Heart Center Freiburg Bad Krozingen

intervention_type: Procedure


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: UCB Pharma

summary: SP0966 is an exploratory study to investigate safety and efficacy of Lacosamide (LCM) in children with epilepsy syndromes associated with generalized seizures. LCM will be added to current antiepileptic treatment.

status: Completed

title: A MULTI-CENTER, OPEN-LABEL, EXPLORATORY STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS ≥1 MONTH TO <18 YEARS WITH EPILEPSY SYNDROMES ASSOCIATED WITH GENERALIZED SEIZURES.

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

study_completion_date_type: Actual

location_country:
Poland
Hungary
Mexico
United States
France

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

acronym: ELEVATE UC OLE

summary: The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

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

collaborators: Arena is a wholly owned subsidiary of Pfizer

sponsor_collaborators: Arena is a wholly owned subsidiary of Pfizer

location_country:
Germany
Poland
Argentina
Australia
Japan
Thailand
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Belarus
Lithuania
Portugal
Slovakia
Hungary
Denmark
United States
Latvia
Ukraine
India
Romania
Lebanon
Belgium
Moldova, Republic of
Estonia
Italy
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria
Georgia
Russian Federation
Israel

location_facility: Pulmonary examination: CHU de Nice - Hopital de I'Archet 2

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

location_facility: P. Stradins Clinical University Hospital, Gastroenterology, Hepatology and Nutrition Therapy Center

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Federal state Budgetary Ed. Inst. of Higher Education "North-Western Medical University n.a.

location_facility: Christus Santa Rosa Physicians Ambulatory Surgery Center San Marcos (Endoscopy)

location_facility: CCR-ICTS Center for Innovative Patient Care

location_facility: IMSP Spitalul Clinic Republican "Timofei Mosneaga"

location_facility: USF Health Morsani Center For Advanced Healthcare

location_facility: Fakultna nemocnica Nitra, Pneumologicka ambulancia

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Centralny Szpital Kliniczny UM w Lodzi (PFT)

location_facility: "University multiprofile hospital for active treatment and emergency medicine N.I. Pirogov"EAD

location_facility: Policlinico Universitario Agostino Gemelli IRCCS -CEMAD -UOC di Medicina lnterna e Gastroenterologia

location_facility: PFT Facility in Dong-A University Hospital

location_facility: Centrum Medycyny Oddechowej, Mroz Spolka Jawna (PFT, DLCO)

location_facility: Digestive Disease Specialists, Inc. Endoscopy Lab

location_facility: Instituto de Patologias Respitatorias (Pulmonary Function Test)

location_facility: Ophthalmology tests:Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ,Szemészeti Kli

location_facility: Clinical Diagnostical Center "Simedgroup"

location_facility: MEDICOME- Oswiecimskie Centrum Medyczne (OCT)

location_facility: Healthcare Institution "Grodno University Hospital"

location_facility: Acibadem City Clinic Tokuda Hospital EAD

location_facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center, LTD

location_facility: Dolnoslaskie Centrum Chorob Pluc We Wroclawiu

location_facility: University of South Florida "Administrative Office"

location_facility: IRCCS Ospedale San Raffaele, Unita di Gastroenterologia

location_facility: Tomography: CHU Grenoble Alpes - Hopital Michallon

location_facility: Tokyo Medical And Dental University Hospital

location_facility: Medical Eye Services LTD (Ophthalmoscopy with OCT)

location_facility: GASTRO-NELL s.r.o., MUDr. Vladimir Vaculin

location_facility: Diagnostic-Consultative Center I - Sliven, EOOD

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Spedali Civili di Brescia, U.O. Gastroenterologia

location_facility: Retina Consultants of Southwest Florida, PA "OCT"

location_facility: S.R.Kalla Memorial Gastro & General Hospital

location_facility: Centro de lnvestigacion Medico Biologica y Terapia Avanzada S.C.

location_facility: Christus Trinity Mother Frances Endosopy Center ( endoscopies only)

location_facility: MACULA CENTER Dana M. Deupree, M.D., F.A.C.S (OCT)

location_facility: Chulalongkorn University, King Chulalongkorn Memorial Hospital

location_facility: Endoscopy Facility in Kyungpook National University Chilgok Hospital

location_facility: Autonomous Noncommercial Medical Organizations " Stavropol Regional Clinical Diagnostic Centre ''

location_facility: UCI Health Eye Care Services (Ophthalmoscopy and OCTs)

location_facility: Health care Institution "Vitebsk Regional Clinical Hospital"

location_facility: Communal Noncommercial Enterprise City Clinical Hospital # 13 of Kharkiv City Council,

location_facility: Retina Associates of Cleveland, Inc. (OCT only)

location_facility: Our Lady of the Snow St. Mary's Hospital

location_facility: Herlev Hospital, Stomach, -Bowel and Liver disease, Clinic 1

location_facility: Acibadem City clinic University Hospital EOOD

location_facility: Newsome Eye Specialist (OCT Procedures Only)

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Pulmonary function tests: Vasutegeszsegugyi Nonprofit Kozhasznu Kft.

location_facility: Endoscopy Facility in Kyungpook National University Hospital

location_facility: PFT Facility in Kyungpook National University Chilgok Hospital

location_facility: Safety Harbor Surgery (Endoscopy Facility)

location_facility: Cross Timbers Surgery Center(Proctosigmoidoscopy)

location_facility: Irkutsk State Medical Academy of Postgraduate Education

location_facility: GASTRO I., s.r.o. Gastroenterologicka ambulancia

location_facility: ALLMEDICA spolka z o.o (OCT/ophthalmoscopy)

location_facility: Centra Medyczne 'MEDYCEUSZ" (OCT, PFT, DLCO, Ophthalmoscopy)

location_facility: State Budgetary Healthcare Instit. of Nizhniy Novgorod region

location_facility: Municipal Health Care "Kharkiv City Hospital Ambulance and Emergency Medical care named alter prof.

location_facility: Grant Medical Foundation Ruby Hall Clinic

location_facility: Institution "Gomel Regional Specialized Clinical Hospital"

location_facility: West Coast Endoscopy Center (Endoscopy Procedures)

location_facility: ISMP Spitalul Clinic Republican "Timofei Mosneaga", RTL SM

location_facility: Dothan Eyecare-Dr. Brent McKinley (OCT Location)

location_facility: University of Cincinnati Medical Center Department of Pharmacy Services

location_facility: Gastro Florida (Administrative & Regulatory Duties)

location_facility: Krankenhaus Waldfriede e. V. Studienambulanz lnnere Medizin

location_facility: Japan Community Health care Organization Osaka Hospital

location_facility: Barts Health NHS Trust - Whipps Cross University Hospital

location_facility: Pulmonary function tests, endoscopy: Deak Jeno Korhaz

location_facility: Diagnostic Consultation Center CONVEX EOOD

location_facility: Communal Noncommercial Enterprise Lviv Clinical Emergency Hospital, 1st Department of Therapy

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Ocni ordinace Olomouc (OCT/ophtalmoscopy)

location_facility: Gastroenterologie, MUDr. Michal Konecny, Ph.D., s.r.o.

location_facility: Endoscopy Center (For Endoscopy procedure)

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie Klinika Chorob Wewnetrznych i Gastroenterologii

location_facility: Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test)

location_facility: Pulmonary examination: CHU Grenoble Alpes - Hopital Michallon

location_facility: Research Associates of South Florida, LLC(IP address)

location_facility: Communal Nonprofit Enterprise M.I.Pyrogov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional

location_facility: Barnes-Jewish West County Hospital (Additional Endoscopy Location)

location_facility: Gastroenterologicka ordinace, MUDr. Pavla Skalova s.r.o., MUDr. Frantisek Sincl s.r.o.

location_facility: State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"

location_facility: Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca

location_facility: Accout Center, s.r.o., Gastroenterologicka ambulancia

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I .Belgyogyaszati Klinika

location_facility: Gastromed Kralisz, Romatowski, Stachurska sp.j.

location_facility: "Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia"

location_facility: Foreign Medical and Pharmaceutical Unitary Enterprise "Medical Center" Novoe Zrenie"

location_facility: OCT Facility in The Catholic University of Korea, St. Vincent's Hospital

location_facility: Pulmonary examination: Hopital Arnaud de Villeneuve

location_facility: Gastro Florida-(Regulatory & Administrative Duties)

location_facility: United Surgery Center Temecula [Endoscopy Only]

location_facility: Endoscopy: North Estonia Medical Centre Foundation

location_facility: Chevy Chase Endoscopy Center (Endoscopy Facility Only)

location_facility: Dr Fritz Potgieter, Midstream Medi Clinic

location_facility: OCT Facility in Kyungpook National University Hospital

location_facility: Kyiv City Clinical Hosptial #1, Department of Therappy #2

location_facility: Centro Oftalmologico Lischinsky (Optical Coherence Tomography, Ophtalmoscopy)

location_facility: Ophthalmology tests: Tolna Megyei Balassa Janos Korhaz

location_facility: SAIH "Kemerovo Regional Clinical Hospital"

location_facility: UCSD Clinical and Translational Research Institute (Research Clinic)

location_facility: Larkin Community Hospital (For endoscopy procedure)

location_facility: Atlanta Gastroenterology Associates (endoscopy only)

location_facility: Libertyville Imaging Center (Diagnostic Imaging)

location_facility: Centro Hospitalar e Universitario de Coimbra, E.P.E.

location_facility: Private Educational Institution of Higher Education "Medical University "Reaviz", Multifield Clinic

location_facility: U.O.C. Gastroenterologia ed Endoscopia Digestiva

location_facility: Endoscopy: CHU Grenoble Alpes- Hopital Michallon

location_facility: Health Care Institution "City Clinical Hospital #4 Grodno"

location_facility: Iwate Medical University Uchimaru Medical Center

location_facility: LLC "Multidisciplinary Medical Clinic "Anturium"

location_facility: Department of Internal Medicine III, Clinical Division of Gastroenterology and Hepatology

location_facility: Consultancy Polyclinic of Republican Panevezys Hospital

location_facility: Endoscopy Facility in The Catholic University of Korea, St. Vincent's Hospital

location_facility: Washington University School of Medicine

location_facility: Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO)

location_facility: USF Health South Tampa Center for Advanced Healthcare

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC

location_facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji

location_facility: UAB "Inlita", Santaros Clinical Trials Centre

location_facility: UCI Investigational Drug Services (IDSP - Pharmacy)

location_facility: Regional Clin Hospital, Dep ofGastroenterology, State Higher Educational Institution Ivano-Frankivsk

location_facility: Podkarpackie Centrum Chorob Pluc w Rzeszowie (DLCO)

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte Medizinische Klinik m. S. Hepatologie

location_facility: Shiga University of Medical Science Hospital

location_facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca

location_facility: Baylor College of Medicine- Baylor Medical Center

location_facility: UAB "Northway", Medical and Surgical Centre

location_facility: Amulance alergologie a klinicke imunologie - MUDr. Pavlina Kazinotova, s.r.o.

location_facility: Debreceni Egyetem, Belgyogyaszati Klinika, Gasztroenterologiai Osztaly

location_facility: OCT- Drushti Eye clinic and squint centre

location_facility: PFT Facility in Kyungpook National University Hospital

location_facility: OCULOSANUS, s.r.o., Oftalmologicka ambulancia

location_facility: Communal Institution Odesa Regional Clinical Hospital, Regional Center of Gastroenterology,

location_facility: Alkek Eye Center Jamail Specialty Care Center (OCT)

location_facility: Allmedica Badania Kliniczne Sp. z o.o. Sp. k.

location_facility: University of Cincinnati Medical Center (PFT and Endoscopy location)

location_facility: JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

location_facility: West Coast Endoscopy Center (Endoscopy Facility)

location_facility: Pulmonary and Sleep of Tampa Bay (PFT Only)

location_facility: Baylor College of Medicine-Baylor Medical Center (Chest X-ray location)

location_facility: Lynchburg Pulmonary Associates, Inc. (PFT only)

location_facility: Monza Oncology Hospital. Gastroenterology Department

location_facility: Communal Noncommercial Enterprise Prof. O.O.Shalimov City Clinical Hospital #2 of Kharkiv City

location_facility: Clinical Center " Dr Dragisa Misovic-Dedinje"

location_facility: Azienda Ospedaliero Universitaria Careggi, U.O. Gastroenterologia 2

location_facility: PULMOX spol. s r.o., Pneumologicko-ftizeologicka ambulancia

location_facility: Ophthalmology tests: Budapest Retina lntezet

location_facility: Clinical Medical Research sp. z o.o. (OCT. ophthalmoscopy)

location_facility: FSBEI of Higher Education "First Saint Petersburg State Medical University n.a. I.P. Pavlov"

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

location_facility: Endoscopy: CHU de Nice - Hopital de I'Archet 2

location_facility: A V Pediatrics,Allergy and Family Medicine

location_facility: North Shore Endoscopy Center (Endoscopy)

location_facility: Government Medical College & Super Speciality Hospital

location_facility: Saglik Bilimleri Universitesi Antalya Egitim ve Arastirma Hastanesi

location_facility: Cross Eye Center (Optical Coherence Tomography)

location_facility: Servicios Medicos y de lnvestigacion Clinica Inspirepharma S. de R.L. de C.V.

location_facility: UT Health East Texas Physicians (pulmonary functions only)

location_facility: LTD Academician Nikoloz Kipshidze Central University Clinic

location_facility: Karkonoskie Centrum Badan Klinicznych - Lexmedica Spolka z ograniczona odpowiedzialnoscia

location_facility: Centro de lnvestigation C.I .C.E. 9 de Julio

location_facility: Sunshine Coast University Private Hospital

location_facility: Digestive Health Specialists (IP Address)

location_facility: Centrum Dentystyczno-Lekarskie PROMEDICA Joanna Markiewicz

location_facility: Healthcare Institution: Vitebsk Regional Clinical Specialized Center

location_facility: Hospital Senhora da Oliveira Guimaraes, E.P.E

location_facility: Educational Establishment "Vitebsk State Medical University"

location_facility: JA- Kagoshima Koseiren Hospital (PET/DLCO)

location_facility: PFT Facility in Yonsei University Wonju Severance Christian Hospital

location_facility: Institution "Gomel Regional Clinical Hospital

location_facility: Gastroenterologicka ambulance, MUDr. Marcela Vyslouzilova

location_facility: Endoscopy Facility in Yonsei University Wonju Severance Christian Hospital

location_facility: Fakultna nemocnica Nitra, Oftalmologicka ambulancia

location_facility: Endoscopy Facility in Dong-A University Hospital

location_facility: State Budgetary Healthcare Institution of Novosibirsk region "City clinical hospital # 12"

location_facility: UCSD lnvestigational Drug Service Pharmacy (Pharmacy Only)

location_facility: Federal State Budgetary Ed. Inst. of Higher Education "North-Western Medical University n.a. I.I.

location_facility: Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City

location_facility: Israeli-Georgian Medical Research Clinic Helsicore, LTD

location_facility: National Hospital Organization Yokohama Medical Center

location_facility: Osrodek Okulistyczny Okolek (Oct, Ophtalmoscopy)

location_facility: Autonomous Noncommercial Medical Organizations "Stavropol Regional Clinical Diagnostic Centre''

location_facility: ENDOMED. s.r.o., Gastroenterologicka ambulancia

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

location_facility: UCI Irvine Medical Center - Pulmonology Services - PFTs

location_facility: Antelope Valley Eye Care(Ophthalmologist)

location_facility: Atlanta Gastroenterology Associates(IP only)

location_facility: National Hospital Organization Kyoto Medical Center

location_facility: Baylor College of Medicine-Baylor Medical Center ( IP Storage)

location_facility: Investigational Drug Services (Pharmacy)

location_facility: Gastroenterologicka ambulance, Nemocnice Boskovice

location_facility: KM Management, spol. s r.o .. Gastroenterologicke a hepatologicke centrum

location_facility: DLCO and Ophthalmology tests: Szent Borbala Korhaz

location_facility: Baylor St.Luke's Medical Center Endoscopy-Mc Nair Campus (Endoscopy Location)

location_facility: Pulmonary Critical Care of Atlanta (PFT)

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Communal Institution I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital, Department of

location_facility: Scientific and Research Institute of Invalid Rehabilitation (Educational and Scientific Treatment

location_facility: Brighton Surgical Center (endoscopy center - Nicholas Karyotakis - endoscopist)

location_facility: Pulmonary and Critical Care Medicine Associates (PFT only)

location_facility: Szpital Specjalistyczny Chorob Pluc "Odrodzenie" im. Klary Jelskiej (DLCO, PFT)

location_facility: EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: ALIAN. s.r.o .. Ambulancia vnutorneho lekarstva

location_facility: Endoskopicke pracoviste, Interni oddeleni

location_facility: SUBARU Health Insurance Society Ota Memorial Hospital

location_facility: PFT and Endoscopy- Midas Multispeciality Hospital Pvt. Ltd

location_facility: Ophthalmology tests: Magyar Honvedseg Egeszsegugyi Kozpont

location_facility: Emc Instytut Medyczny Sa Przychodnia Przy Ul.Lowieckiej (Pft)

location_facility: Centro Hospitalar Universitario de Sao Joao, E.P.E

location_facility: Texas Pulmonary and Critical Care Associates(Pulmonary Function Test)

location_facility: Aalborg University Hospital, department of medical gastroenterology,

location_facility: Salve Health Care Sp. z o.o (OCT, Endoscopy, Ophtalmoscopy)

location_facility: LoCicero Medical Group (PFT Procedure Only)

location_facility: Clinical Pathology Laboratory (Diagnostick center)

location_facility: ASST Rhodense - U.O.C. di Gastroenterologia ed Endoscopia Digestiva

location_facility: Medical Corporation Tokushukai Kishiwada Tokushukai Hospital

location_facility: Andrii Novak Transcarpathian Regional Clinical Hospital, Department of Gastroenterology

location_facility: MUDr. Michal Popovec, s.r.o., Oftalmologicka ambulancia

location_facility: Illinois Gastroenterology Group-Gurnee (Patients Seen; IP Delivered)

location_facility: Coral Sea Clinical Research Institute Pty.Ltd

location_facility: Renaissance Imaging Center(Chest X-Ray only)

location_facility: COR, s.r.o., Pneumologicko-ftizeologicka ambulancia

location_facility: Japan Community Health Care Organization Kyushu Hospital

location_facility: OCT Facility in Yonsei University Wonju Severance Christian Hospital

location_facility: OCT Facility in Kyungpook National University Chilgok Hospital

location_facility: Pulmonary examination: CHU Amiens-Picardie

location_facility: DEJA. s.r.o .. Oftalmologicka ambulancia

location_facility: Center for Digestive Health (Colonoscopy Location)

location_facility: St.Petersburg State Budgetary Healthcare Institution "City Hospital #40 of Kurortnyi region"

location_facility: I.R.C.C.S "Saverio De Bellis", Gastroenterologia II

location_facility: Communal Non-commercial Enterprise Regional Clinical Hospital of lvano-Frankivsk Regional Council,

location_facility: Medical Clinical Investigational Center of Med Center LLC Health Clinic, Unit of Gastroenterology,

location_facility: Health Care Institution "Vitebsk Regional Clinical Hospital"

location_facility: Privatni gastroenterologicka ambulance s.r.o., MUDr. Zdenek Vlk

location_facility: National Hospital Organization Fukuyama Medical Center

location_facility: United Surgery Center Murrieta [Endoscopy Only]

location_facility: Chevy Chase Pulmonary Associate (PFT Only)

location_facility: Ophthalmology tests:Bekes Megyei Kozponti Korhaz, Pady Kalman Tagkorhaz, Szemeszeti Osztaly

location_facility: Health care Institution "10th City Clinical Hospital"

location_facility: IRCCS Ospedale San Raffaele UO di Gastroenterologia e Endoscopia Digestiva

location_facility: Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii (PFT)

location_facility: Pulmonary Associates (Secondary PFT Location)

location_facility: Japan Community Health care Organization Saitama Medical Center

location_facility: Absolute Surgical Specialists - Craig Amshel, MD

location_facility: Advanced Endoscopy and Pain Center(Colonoscopy)

location_facility: Wojewodzki Szpital Specjalistyczny im.dr. WI. Bieganskiego (endoscopy)

location_facility: American University of Beirut Medical Center

location_facility: UCI Health H. H. Chao Comprehensive Digestive Disease Center

location_facility: Hospital General Universitario de Alicante

location_facility: SP ZOZ w Swidnicy, Regionalny Szpital Specjalistyczny, Poradnia Gruzlicy i Chorob Pluc (Spirometry)

location_facility: Social Welfare Organization Imperial Gift Foundation,Inc.Saiseikai Yokohamashi Nanbu Hospital

location_facility: PFT Facility in The Catholic University of Korea, St. Vincent's Hospital

location_facility: CHU Clermont Ferrand - Hopital Gabriel Montpied

location_facility: National Medical University, Dep of Surgery, Vinnytsia M.I.Pyrogov National Medical University,

location_facility: Tomography: CHU de Nice - Hopital de I'Archet 2

location_facility: State Healthcare Institution of Yaroslavl Region "Clinical Hospital No 2"

location_facility: Yeovil District Hospital NHS Foundation Trust

location_facility: Christus Santa Rosa Physicians Ambulatory Surgery Center New Braunfels (Endoscopy)

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Northwood Vision-Optical Coherence Tomography-(OCT)

location_facility: Northwood Vision- Optical Coherence Tomography (OCT)

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Spoldzielnia Pracy Lekarzy Medicus (OCT, ophtalmoscopy)

location_facility: PROMED Centrum Medyczne (OCT, ophthalmoscopy)

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica, II. Interna klinika SZU

location_facility: OCT Facility in Dong-A University Hospital

location_facility: Strzegomskie Centrum Medyczno - Diagnostyczne (Endoscopy)

location_facility: Vilnius University Hospital Santaros Klinikos

status_simplified: Ongoing


acronym: CARDINAL

lead_sponsor: Biogen

summary: This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180 patients.

ReferenceType: derived

ReferenceCitation: Chertow GM, Appel GB, Andreoli S, Bangalore S, Block GA, Chapman AB, Chin MP, Gibson KL, Goldsberry A, Iijima K, Inker LA, Knebelmann B, Mariani LH, Meyer CJ, Nozu K, O'Grady M, Silva AL, Stenvinkel P, Torra R, Warady BA, Pergola PE. Study Design and Baseline Characteristics of the CARDINAL Trial: A Phase 3 Study of Bardoxolone Methyl in Patients with Alport Syndrome. Am J Nephrol. 2021;52(3):180-189. doi: 10.1159/000513777. Epub 2021 Mar 31.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: 5x21tq901;PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: S. Karger AG

ReferenceCitation: Kashtan CE, Gross O. Clinical practice recommendations for the diagnosis and management of Alport syndrome in children, adolescents, and young adults-an update for 2020. Pediatr Nephrol. 2021 Mar;36(3):711-719. doi: 10.1007/s00467-020-04819-6. Epub 2020 Nov 6. Erratum In: Pediatr Nephrol. 2021 Jan 12;:

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

location_facility: The Warren Alpert Medical School of Brown University

location_facility: Hopital Necker-Universite Paris Descartes

location_facility: University of Pittsburgh School of Medicine - Division of Pediatric Nephrology

location_facility: University Children's Hospital Heidelberg

location_facility: University of Minnesota - Division of Pediatric Nephrology

location_facility: South Carolina Nephrology & Hypertension Center, Inc

location_facility: Washington University School of Medicine

location_facility: General Clinical Research Center - Parnassus

location_facility: Children's Hospital of Philadelphia (CHOP)

location_facility: Emory University School of Medicine and Children's Healthcare of Atlanta

location_facility: University of California San Francisco - Children's Renal Center

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Arizona Kidney Disease and Hypertension Research Services, PLLC

location_facility: Tokyo Metropolitan Children's Medical Center

location_facility: Puerto Rico Clinical & Translational Research Center

location_facility: Brookview Hills Research Associates, PLLC

location_facility: Children's Research Institute - The Children's Mercy Hospital

title: A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

design_allocation: Randomized

location_country:
Germany
United Kingdom
Australia
Japan
United States
Spain
Puerto Rico
France


acronym: APHINITY

lead_sponsor: Hoffmann-La Roche

summary: This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).

ReferenceCitation: Gelber RD, Wang XV, Cole BF, Cameron D, Cardoso F, Tjan-Heijnen V, Krop I, Loi S, Salgado R, Kiermaier A, Frank E, Fumagalli D, Caballero C, de Azambuja E, Procter M, Clark E, Restuccia E, Heeson S, Bines J, Loibl S, Piccart-Gebhart M; APHINITY Steering Committee and Investigators. Six-year absolute invasive disease-free survival benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A Subpopulation Treatment Effect Pattern Plot (STEPP) analysis of the APHINITY (BIG 4-11) trial. Eur J Cancer. 2022 May;166:219-228. doi: 10.1016/j.ejca.2022.01.031. Epub 2022 Mar 18.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories_institution: University of Edinburgh - Edinburgh Research Explorer

publisher_dissemination: Elsevier

ReferenceCitation: Bines J, Clark E, Barton C, Restuccia E, Procter M, Sonnenblick A, Fumagalli D, Parlier D, Arahmani A, Baselga J, Viale G, Reaby LL, Frank E, Gelber RD, Piccart M, Jackisch C, Petersen JA. Patient-reported function, health-related quality of life, and symptoms in APHINITY: pertuzumab plus trastuzumab and chemotherapy in HER2-positive early breast cancer. Br J Cancer. 2021 Jul;125(1):38-47. doi: 10.1038/s41416-021-01323-y. Epub 2021 Apr 7.

oa_colors: green other

evidence: open (via free pdf)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

ReferenceCitation: Piccart M, Procter M, Fumagalli D, de Azambuja E, Clark E, Ewer MS, Restuccia E, Jerusalem G, Dent S, Reaby L, Bonnefoi H, Krop I, Liu TW, Pienkowski T, Toi M, Wilcken N, Andersson M, Im YH, Tseng LM, Lueck HJ, Colleoni M, Monturus E, Sicoe M, Guillaume S, Bines J, Gelber RD, Viale G, Thomssen C; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up. J Clin Oncol. 2021 May 1;39(13):1448-1457. doi: 10.1200/JCO.20.01204. Epub 2021 Feb 4.

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

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Bines J, Procter M, Restuccia E, Viale G, Zardavas D, Suter T, Arahmani A, Van Dooren V, Baselga J, Clark E, Eng-Wong J, Gelber RD, Piccart M, Mobus V, de Azambuja E; APHINITY Steering Committee and Investigators. Incidence and Management of Diarrhea With Adjuvant Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. Clin Breast Cancer. 2020 Apr;20(2):174-181.e3. doi: 10.1016/j.clbc.2019.06.016. Epub 2019 Sep 5.

ReferenceCitation: Luo Y, Li W, Jiang Z, Zhang Q, Wang L, Mao Y, Tjan-Heijnen VCG, Im SA, McConnell R, Bejarano S, Fumagalli D, Bines J, Wang B, Garg A, Kirschbrown WP, Xu B. Pharmacokinetics of pertuzumab administered concurrently with trastuzumab in Chinese patients with HER2-positive early breast cancer. Anticancer Drugs. 2019 Sep;30(8):866-872. doi: 10.1097/CAD.0000000000000808.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Kirschbrown WP, Kagedal M, Wang B, Lindbom L, Knott A, Mack R, Monemi S, Nijem I, Girish S, Freeman C, Fumagalli D, McConnell R, Jerusalem G, Twelves C, Baselga J, von Minckwitz G, Bines J, Garg A. Pharmacokinetic and exploratory exposure-response analysis of pertuzumab in patients with operable HER2-positive early breast cancer in the APHINITY study. Cancer Chemother Pharmacol. 2019 Jun;83(6):1147-1158. doi: 10.1007/s00280-019-03826-1. Epub 2019 Apr 11.

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

ReferenceCitation: von Minckwitz G, Procter M, de Azambuja E, Zardavas D, Benyunes M, Viale G, Suter T, Arahmani A, Rouchet N, Clark E, Knott A, Lang I, Levy C, Yardley DA, Bines J, Gelber RD, Piccart M, Baselga J; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017 Jul 13;377(2):122-131. doi: 10.1056/NEJMoa1703643. Epub 2017 Jun 5. Erratum In: N Engl J Med. 2017 Aug 17;377(7):702. N Engl J Med. 2018 Oct 18;379(16):1585.

evidence: open (via free article)

version: acceptedVersion

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

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

sponsor_collaborators:
Hoffmann-La Roche
Genentech, Inc.
Breast International Group

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Washington Cancer Institute at MedStar Washington Hospital Center.

location_facility: Uni Hospital of North Staffordshire; Staffordshire Oncology Centre

location_facility: Opolskie Centrum Onkologii;Oddzial Onkologii Klinicznej

location_facility: Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde

location_facility: IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia

location_facility: Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe

location_facility: Heartland CCOP/Missouri Baptist Medical Center

location_facility: Natl Hosp Org Shikoku; Cancer Ctr, Surgery

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Tom Baker Cancer Centre; Dept of Medicine

location_facility: MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: National Cancer Center Hospital; Medical Oncology

location_facility: Kyoto University Hospital; Breast Surgery

location_facility: Quincy Medical Group; Canc Ctr at Blessing Hosp

location_facility: Chiba Cancer Center; Breast Surgical Oncology

location_facility: Newcastle Mater Misericordiae Hospital; Oncology

location_facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

location_facility: Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Klinikum Chemnitz gGmbH; Frauen- und Kinderklinik

location_facility: The 900th Hospital of PLA joint service support force

location_facility: Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

location_facility: The Clatterbridge Cancer Ctr For Oncolgy

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

location_facility: Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Hospital Juan Ramon Jimenez;Servicio de Oncologia

location_facility: S.I. Russian Oncological Research Center n.a. N.N. Blokhin

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

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

location_facility: Clinica Anglo Americana - Centro de Investigacion Oncologia CAA

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Geelong Hospital; Andrew Love Cancer Centre

location_facility: Ist. Uni Federico Ii; Divisione Di Oncologia Medica - Dpt. Di Medicina Interna

location_facility: Abramson Cancer Center; Univ of Pennsylvania

location_facility: Royal Berkshire Hospital; Berkshire Cancer Centre

location_facility: Sydvestjysk Sygehus Esbjerg; Onkologisk afdeling

location_facility: Peter Maccallum Cancer Institute; Medical Oncology

location_facility: Royal Devon & Exeter Hospital; Oncology Centre

location_facility: St. Bartholomew'S Hospital; Dept of Medical Oncology

location_facility: University Of Santo Tomas; Oncology; Benavides Cancer Institute

location_facility: Luzerner Kantonsspital; Medizinische Onkologie

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

location_facility: Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker

location_facility: Harbin Medical University Cancer Hospital

location_facility: Tri-Service General Hospital, Division of General Surgery

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Uni Hospital Linkoeping; Dept. of Oncology

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1

location_facility: Western General Hospital; Edinburgh Breast Unit

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Albert Einstein Healthcare Network ; Cancer Center

location_facility: Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit

location_facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

location_facility: Lismore Base Hospital; Cancer Care & Haematology Unit

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University

location_facility: Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe

location_facility: Gunma University Hospital; Department of Thoracic and Visceral Organ Surgery

location_facility: Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: Cancer Care Centers of South Texas-HOAST - San Antonio

location_facility: Nuovo Ospedale di Prato S. Stefano - Azienda USL Toscana Centro

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Lkh Vöcklabruck; I. Abt. Für Innere Medizin

location_facility: Beth Israel Deac Med Ctr; East Campus Rsch Pharmacy

location_facility: Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

location_facility: Universitätsklinikum Bonn; Zentrum für Geburtshilfe und Frauenheilkunde

location_facility: Eastern Ct Hema/Onco Assoc; Dept of Oncology

location_facility: National Hospital Organization Osaka National Hospital; Breast Surgery

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: University of Missouri-Columbia; Ellis Fischel Cancer Center

location_facility: Ospedale S. Croce Di Fano; Servizio Oncologia

location_facility: Florida Cancer Specialists; Saint Petersburg

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

location_facility: Centro Estatal De Cancerologia De Durango; Oncology

location_facility: Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche

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

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: Centro de Diagnóstico y Tratamiento Integral de Mama, Hospital San José Tec de Monterrey

location_facility: The Cancer Inst. Hosp. of JFCR; Breast Oncology Center

location_facility: DONAU ISAR Klinikum Deggendorf; Frauenklinik

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

location_facility: Cheltenham General Hospital; Gloucestershire Oncology Centre

location_facility: Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

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

location_facility: Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

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

location_facility: St Vincent'S Uni Hospital; Medical Oncology

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Dres. Arnd Nusch Naser Ali-Mohammad Kalhori und Werner Langer

location_facility: St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery

location_facility: Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

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

location_facility: Texas Oncology-El Paso Cancer Treatment Center Grandview

location_facility: Galway University Hospital; Clinical Trials Department

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

location_facility: Brustzentrum Rhein-Ruhr Servicegesellschaft mbH

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Ch Pitie Salpetriere; Cmrr Ile De France Salpetriere

location_facility: SANA Klinikum Hameln-Pyrmont; Frauenklinik / Brustzentrum

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

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

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

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Hämatologisch/Onkologische Praxis Prof. Dr. Decker, Studienzentrum

location_facility: Azienda Ospedaliera S. Maria - Terni; Oncologia

location_facility: MULTISCAN, s.r.o., Radiologicke centrum Pardubice

location_facility: Isis Centro Especializado de Luces; Oncology

location_facility: Atlantic Health Science Corporation; Saint John Regional Hospital Facility

location_facility: Cancer Center of Acadiana at Lafayette General

location_facility: Tokai University Hospital, Breast Surgery

location_facility: Centre Oscar Lambret; Cancerologie Gynecologique

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Taichung Veterans General Hospital; Dept of Surgery

location_facility: University Hospital coventry; Oncology Department

location_facility: NZOZ Mazowiecki Szpital Onkologiczny Uczelni Warszawskiej im. M. Sk?odowskiej-Curie

location_facility: Florida Cancer Specialists, Research Department

location_facility: Mount Sinai Beth Israel Comprehensive Cancer Center

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

location_facility: Wits Donald Gordon Clinical Trial Centre; Medical Oncology

location_facility: RoMed Klinikum Rosenheim; Klinik für Gynäkologie und Geburtshilfe

location_facility: Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre

location_facility: Osaka International Cancer Institute; Breast and Endocrine Surgery

location_facility: Niagara Health Systems - St. Catherines General Site; Niagara Health System-St. Catharines Site

location_facility: Northeastern Ontario; Regional Cancer Centre

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia

location_facility: Ivano-Frankivsk Regional Oncology Center

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I

location_facility: Bcca - Vancouver Island Cancer Centre; Oncology

location_facility: Az. Osp. Di Busto P.O. Di Saronno; U.O. Di Oncologia Medica

location_facility: Carolina Oncology Specialists, PA - Hickory

location_facility: Institut d'oncologie de l'Orangerie; Chimiotherapie

location_facility: Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Palmerston North Hospital; Regional Cancer Treatment Service

location_facility: Lopburi Cancer Hospital; Chemotherpy Unit; Chemotherapy

location_facility: National Hospital Organization Kyushu Cancer Center;Breast Oncology

location_facility: Centre Georges-François Lecler; Ctr de Lutte Contre le Canc

location_facility: HonorHealth Research Institute ? Bisgrove

location_facility: The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.

location_facility: Saitama Medical University International Medical Center; Breast Oncology

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

location_facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

location_facility: Klinikum Kreuzschwestern Wels; Iii. Interne Abt.

location_facility: Ospedale Mater Salutis; Dept of Oncology

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A

location_facility: Fujian Medical University Union Hospital

location_facility: Centre Francois Baclesse; Recherche Clinique

location_facility: Karolinska University Hospital; Department of General Oncology

location_facility: Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde

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

location_facility: Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum

location_facility: Queen Alexandra Hospital; Haematology and Oncology Centre

location_facility: Sir Charles Gairdner Hospital; Medical Oncology

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

location_facility: Chum Hopital Notre Dame; Centre D'Oncologie

location_facility: Northwest Cancer Specialists - Portland (NE Hoyt St)

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Policlinico di Monza; Istituto di Oncologia

location_facility: Marien-Hospital Witten; Frauenklinik Brustzentrum

location_facility: Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie

location_facility: Metro-Minnesota Community Oncology Research Consortium

location_facility: Petz Aladar Megyei Oktato Korhaz; Oncoradiologia

location_facility: UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe

location_facility: Arcispedale Santa Maria Nuova; Oncologia

location_facility: Mount Vernon Hospital; Centre For Cancer Treatment

location_facility: University of North Carolina-Chapel Hill

location_facility: HOP Prive Arras Les Bonnettes; Chimiotherapie

location_facility: The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Songklanagarind Hospital; Department of Surgery

location_facility: Veterans Memorial Medical Ctr; Cancer Research Centre

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

location_facility: Städtische Kliniken Frankfurt am Main Höchst

location_facility: Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich

location_facility: Hospital Angeles Metropolitano; Room 220

location_facility: Mater Misericordiae Hospital; Chemotherapy Cottage

location_facility: Westmead Hospital; Medical Oncology and Pallative Care

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Hospital General de México; Unidad de Oncologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Cancer Centers of the Carolina; Eastside Medical Center

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

location_facility: Cancer Centre of Southeastern Ontario; Kingston General Hospital

location_facility: UMHAT Tsaritsa Yoanna - ISUL; Clinic of Oncotherapy

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Lvov State Regional Oncology Medical & Diagnostic Center

location_facility: Tokyo Medical Uni. Hospital; Breast Oncology

location_facility: ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik

location_facility: Buddhachinaraj Phitsanulok Hospital; Chemotherapy Unit ; Department of Medicine

location_facility: Roper Bon Secours St. Francis Cancer Center

location_facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

location_facility: IRCCS Fondazione Maugeri; Oncologia Medica I

location_facility: Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology

location_facility: Kumamoto Shinto General Hospital; Breast Cancer Center

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

location_facility: Waikato Hospital; Dept of Medical Oncology

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

location_facility: Korea University Anam Hospital; Oncology Haemotology

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

location_facility: Hopital Hautepierre; Hematologie Oncologie

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

location_facility: Kumamoto City Hospital, Breast and Endocrine Surgery

location_facility: Hiroshima City Hiroshima Citizens Hospital; Breast Surgery

location_facility: Nordsjællands Hospital, Hillerød, Onkologisk Afdeling

location_facility: Uniklinik Köln, Klinik und Poliklinik und Geburtshilfe; Brustzentrum Köln

location_facility: Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Emergency University Bucharest Hospital; Oncology Department

location_facility: HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Vanderbilt Breast Center at One Hundred Oaks

location_facility: SHATOD Dr. Marko Antonov Markov-Varna, EOOD

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica

location_facility: Wesley Medical Centre; Clinic For Haematology and Oncology

location_facility: Centre Henri Becquerel; Oncologie Medicale

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Changhua Christian Hospital; Dept of Surgery

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Klinikum der Universität München; Frauenklinik - Onkologie II

location_facility: Medizinisches Versorgungszentrum am Klinikum Oldenburg GmbH

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Yonsei University Severance Hospital; Medical Oncology

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Kantonsspital St. Gallen; Onkologie/Hämatologie

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

location_facility: IRCCS Istituto Clinico Humanitas; Oncologia

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

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Beaumont Hospital; Cancer Clinical Trials Unit

location_facility: Polyclinique Francheville; MED CHIMIOTHERAPIE RADIOTHERAPIE

location_facility: Sourasky / Ichilov Hospital; Oncology Department

location_facility: Dana Farber Cancer Institute at Faulkner Hospital

location_facility: Clinique Armoricaine Radiologie; Hopital de Jour

location_facility: Hôpitaux Universit. de Genève Gynécologique - Oncologie; Gynécologie

location_facility: Sankt Elisabeth Krankenhaus; Gynaekology

location_facility: Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz

location_facility: Uni Hospital Split; Oncology & Radiotherapy

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

location_facility: Inst. Nacional de Cancerologia; Clinica de Seno

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

location_facility: Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

location_facility: Institut Gustave Roussy; Oncologie Medicale

location_facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

location_facility: Aichi Cancer Center Hospital, Breast Oncology

location_facility: Kyunghee University Hospital; Endocrinology

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: St James Uni Hospital; Icrf Cancer Medicine Research Unit

location_facility: Krankenhaus Der Stadt Wien-Hietzing; Abt. Für Gynäkologie U. Geburtshilfe

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

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Seoul National University Bundang Hospital

location_facility: Bialostockie Ctr Onkologii; Oddzial Chemioterapii Dziennej

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Peterborough City Hospital, Edith Cavell Campus; Oncology Department

location_facility: The Center for Cancer and Blood Disorders - Fort Worth

location_facility: St. Josefs-Hospital Wiesbaden GmbH; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Sjællands Universitetshospital, Næstved; Onkologisk Afdeling

location_facility: Tokyo Metropolitan; Komagome Hospital, Surgery

location_facility: National Cheng Kung Uni Hospital; Surgery

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Chiang Rai Prachanukraw Hospital; Department of Pediatrics, Faculty of Medicine

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: Campus Universitario S.Venuta; Centro Oncologico T.Campanella

location_facility: Norrlands Universitetssjukhus, Umeå, Cancercentrum; Dept of Oncology

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Shizuoka General Hospital; Breast Surgery

location_facility: Centro Regional de Enfermedades Oncológicas, S.A.

location_facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Providence St. Mary Regional Cancer Center

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Evangelisches Krankenhaus; Abt. Gynäkologie und Geburtshilfe

location_facility: Niigata Cancer Ctr Hospital; Breast Surgery

location_facility: Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)

location_facility: State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary

location_facility: Schwarzwald-Baar Klinikum Klinik für Frauenheilkunde und Geburtshilfe

location_facility: A. Ö. Krankenhaus Der Barmherzigen Brüder; Interne Abt.

location_facility: The 1st Affiliated Hospital of Nanchang Unversity

location_facility: Luisenkrankenhaus GmbH & Co. KG., Brustzentrum

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: South Carolina Oncology Associates - SCRI

location_facility: Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie

title: A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Japan
Thailand
Croatia
Chile
Czechia
Canada
France
Slovenia
Colombia
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
Romania
Belgium
China
El Salvador
Peru
Philippines
Italy
Guatemala
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Panama
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

collaborators:
Genentech, Inc.
Breast International Group


title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer's Disease With Option for up to an Additional Two Years of Treatment and an Open-Label Extension With Active Study Treatment

acronym: Scarlet Road

summary:
This multi-center, randomized, double-blind, placebo-controlled parallel-group study will evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo. Participants who consent to be part of the sub study will undergo positron emission tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is 104 weeks in Part 1, with an option for an additional up to 2 years of treatment in Part 2, followed by an open-label extension (Part 3) until July 2020.

The dosing for Parts 1 and 2 was stopped after a planned futility interim analysis showed a low probability of meeting the primary outcome measure with the doses studied. The study has converted to open-label to investigate higher gantenerumab doses.

ReferenceCitation: Klein G, Delmar P, Voyle N, Rehal S, Hofmann C, Abi-Saab D, Andjelkovic M, Ristic S, Wang G, Bateman R, Kerchner GA, Baudler M, Fontoura P, Doody R. Gantenerumab reduces amyloid-beta plaques in patients with prodromal to moderate Alzheimer's disease: a PET substudy interim analysis. Alzheimers Res Ther. 2019 Dec 12;11(1):101. doi: 10.1186/s13195-019-0559-z.

oa_colors: green gold

evidence: oa journal (via doaj)

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

version: submittedVersion

repositories_concat: PubMed Central;digitalcommons.wustl.edu

unpaywall_oa_status: gold

ReferenceCitation: Ostrowitzki S, Lasser RA, Dorflinger E, Scheltens P, Barkhof F, Nikolcheva T, Ashford E, Retout S, Hofmann C, Delmar P, Klein G, Andjelkovic M, Dubois B, Boada M, Blennow K, Santarelli L, Fontoura P; SCarlet RoAD Investigators. A phase III randomized trial of gantenerumab in prodromal Alzheimer's disease. Alzheimers Res Ther. 2017 Dec 8;9(1):95. doi: 10.1186/s13195-017-0318-y. Erratum In: Alzheimers Res Ther. 2018 Sep 27;10(1):99.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Delrieu J, Ousset PJ, Vellas B. Gantenerumab for the treatment of Alzheimer's disease. Expert Opin Biol Ther. 2012 Aug;12(8):1077-86. doi: 10.1517/14712598.2012.688022. Epub 2012 May 15.

RetractionSource: Expert Opin Biol Ther. 2021 Dec;21(12):1-2

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
France
Portugal
Denmark
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Russian Federation
Sweden

location_facility: Hospital das Clinicas - FMUSP; Psiquiatria

location_facility: Charing Cross Hospital; Dept of Neurosciences

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: Unidad de Investigacion en Enfermedades Cronico-Degenerativa; Reumatologia

location_facility: CHU De Caen; Service De Neurologie Dejerine

location_facility: Universitätsklinikum Rostock Zentrum für Nervenheilkunde

location_facility: Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik

location_facility: Royal Adelaide Hospital; Memory Trials Centre

location_facility: Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin

location_facility: Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care

location_facility: Australian Alzheimer's Research Foundation

location_facility: Victoria Centre; Kingshill Research Centre

location_facility: Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

location_facility: Hospital Clinic i Provincial; Servicio de Neurologia

location_facility: IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer

location_facility: Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie

location_facility: Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia

location_facility: Akdeniz University School of Medicine, Neurology Department

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Hopital Pierre Wertheimer; Laboratoire De Neuro Psychologie

location_facility: St. Anne´s University Hospital; Clinical Trials Department

location_facility: City Clinical Hospital # 2 n.a. V.I. Razumovsky

location_facility: Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center

location_facility: Prince of Wales Hospital, Academic Department for Old Age Psychiatry

location_facility: HUG; Département de santé mentale et de psychiatrie Unité de psychiatrie gériatrique

location_facility: Istanbul University Istanbul School of Medicine; Neurology

location_facility: Hop Guillaume Et Rene Laennec; Cmrr St Herblain

location_facility: Jeroen Bosch Ziekenhuis; Polikliniek Geriatrie

location_facility: Estimulacion Magnetica Trnscraneal de Mexico SC.

location_facility: Hospital Universitario Dr. Peset; Servicio de Neurologia

location_facility: University of Rochester Medical Center; Monroe Community Hospital

location_facility: Uni Di Firenze Dip. Scienze Neurol Psic Sod Neurologia 1

location_facility: Llandough Hospital; Llandough Hospital Memory Team 3rd Floor Academic Building

location_facility: Hospital das Clinicas - UFPR; Ciencias da Saude

location_facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona

location_facility: Hospital del Mar; Servicio de Neurologia

location_facility: Instituto De Neurología Cognitiva - INECO

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

location_facility: CHU de Rouen Hopital; Service de Neurologie

location_facility: Universita' Di Parma Istituto Neurologia

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

location_facility: Hopital Hautepierre; Centre dInvestigation Clinique

location_facility: Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research

location_facility: Skånes Universitetssjukhus Malmö, Minneskliniken

location_facility: Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center

location_facility: Universidade Federal de Sao Paulo - UNIFESPX; Neurologia

location_facility: PALLMED Sp. z o.o. prowadząca NZOZ DOM SUE RYDER

location_facility: IME - Instituto Médico Especializado; Ensayos Clínicos

location_facility: Ch Pitie Salpetriere; Cmrr Ile De France Salpetriere

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Moorgreen Hospital; Memory Assessment & Rsch Ctr

location_facility: ALPI-Inst. de Rehabilitacion Marcelo Fitte

location_facility: Univ Berlin; Klin fur Psychi & Psycho Charite

location_facility: Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: Irccs Multimedica Santa Maria; Unita' Di Neurologia

location_facility: Hospital de Santa Maria; Servico de Neurologia

location_facility: Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze

location_facility: Office of Dr Klaus Steinwachs Neurology & Psychiatry

location_facility: Hospital Universitario La Paz; Servicio de Neurologia

location_facility: Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

location_facility: Seoul National University Bundang Hospital; Neurology Department

location_facility: Sverdlovsk Regional Clinical Psychoneurological War Veteran Hospital

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: Hospital Mutua De Terrasa; Servicio de Neurologia

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Neurological and Psychiatric

location_facility: Clinical Neuroscience Research Associates, Inc.

location_facility: Hospital Universitario; Dr. Jose E. Gonzalez

location_facility: Azienda Ospedaliera Spedali Civili; Scienze Neurologiche

location_facility: Campus for Ageing & Vitality; Clincal Ageing Research Unit


lead_sponsor: Boehringer Ingelheim

summary:
The main objective of this study is to identify the dose of linagliptin in paediatric patients.

Other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of treatment.

Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD) and the PK/PD relationship of linagliptin in the paediatric population.

sponsor_collaborators:
Boehringer Ingelheim
Eli Lilly and Company

location_facility: 1218.56.70003 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.33006 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.01006 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.82003 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.48003 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.52001 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.70001 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.52003 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.70006 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.48001 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.01004 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.39005 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.11001 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.52004 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.50202 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.70004 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.50203 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.52002 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.33003 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.48002 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.52008 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.82002 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.82005 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.82001 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.48004 Boehringer Ingelheim Investigational Site

title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Dose-finding Study of Linagliptin (1 and 5 mg Administered Orally Once Daily) Over 12 Weeks in Children and Adolescents, From 10 to 17 Years of Age, With Type 2 Diabetes Mellitus

location_country:
Italy
Poland
Guatemala
Mexico
United States
Korea, Republic of
Canada
Russian Federation
France


title: Precision Event Monitoring for Patients With Heart Failure Using HeartLogic: PREEMPT-HF

acronym: PREEMPT-HF

summary:
The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator. There are no primary safety and/or efficacy endpoints for this study.

Heart failure is a complex clinical syndrome with high morbidity, mortality, and economic burden. Chronic Heart Failure is persistent, gradually progressive, and punctuated by episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet clinical need to slow the progression of Heart Failure and prevent hospitalizations. HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and defibrillators, combines novel sensor parameters such as heart sounds and respiration with other measurements like thoracic impedance, heart rate, and activity into a HeartLogic Index for the early detection of worsening Heart Failure. However, there is limited data on the association of HeartLogic with the risk of Hear Failure readmissions and tachyarrhythmias, or for phenotyping the broad spectrum of Heart Failure patients.

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.

ReferenceCitation: Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.

ReferenceCitation: Gheorghiade M, Pang PS. Acute heart failure syndromes. J Am Coll Cardiol. 2009 Feb 17;53(7):557-573. doi: 10.1016/j.jacc.2008.10.041.

ReferenceCitation: Boehmer JP, Hariharan R, Devecchi FG, Smith AL, Molon G, Capucci A, An Q, Averina V, Stolen CM, Thakur PH, Thompson JA, Wariar R, Zhang Y, Singh JP. A Multisensor Algorithm Predicts Heart Failure Events in Patients With Implanted Devices: Results From the MultiSENSE Study. JACC Heart Fail. 2017 Mar;5(3):216-225. doi: 10.1016/j.jchf.2016.12.011.

ReferenceCitation: Whellan DJ, Lindenfeld J. Easy to Predict, Difficult to Prevent. JACC Heart Fail. 2017 Mar;5(3):226-228. doi: 10.1016/j.jchf.2017.01.006. No abstract available.

ReferenceCitation: Desai AS. The three-phase terrain of heart failure readmissions. Circ Heart Fail. 2012 Jul 1;5(4):398-400. doi: 10.1161/CIRCHEARTFAILURE.112.968735. No abstract available.

ReferenceCitation: Dharmarajan K, Wang Y, Lin Z, Normand ST, Ross JS, Horwitz LI, Desai NR, Suter LG, Drye EE, Bernheim SM, Krumholz HM. Association of Changing Hospital Readmission Rates With Mortality Rates After Hospital Discharge. JAMA. 2017 Jul 18;318(3):270-278. doi: 10.1001/jama.2017.8444.

ReferenceCitation: Shah SJ, Katz DH, Selvaraj S, Burke MA, Yancy CW, Gheorghiade M, Bonow RO, Huang CC, Deo RC. Phenomapping for novel classification of heart failure with preserved ejection fraction. Circulation. 2015 Jan 20;131(3):269-79. doi: 10.1161/CIRCULATIONAHA.114.010637. Epub 2014 Nov 14.

ipd_sharing: Undecided

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Ireland
Italy
United Kingdom
Hong Kong
Denmark
Australia
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: Augusta Kranken Anstalt GmbH - Klinik für Kardiologie und Angiologie

location_facility: St. Francis Health System - St. Francis Hospital

location_facility: Providence Regional Medical Center Everett

location_facility: The University of Texas, Southwestern Medical Center

location_facility: Cardiology Associates of Northeast Arkansas

location_facility: South Manchester University Hospital Trust

location_facility: Christus Trinity Mother Frances Health System

location_facility: Strong Memorial Hospital of the University of Rochester

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: Baptist Health Medical Center (Little Rock)

location_facility: University of Iowa Hospitals and Clinics

intervention_type: Device


title: A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABBV-668 in Subjects With Moderate to Severe Ulcerative Colitis

summary:
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective ABBV-668 is in treating adult participants with UC. Adverse events and change in disease activity will be assessed.

ABBV-668 is an investigational drug being developed for the treatment of moderate to severe UC. Approximately 40 adult participants diagnosed with UC will be enrolled in approximately 23 sites globally.

Participants will receive oral capsules of ABBV-668 twice daily for 16-weeks and will undergo a 30 day follow-up period.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
United States
Poland
Belgium
France

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 249217

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 251876

location_facility: Southern Star Research Institute, LLC /ID# 249212

location_facility: H-T. Centrum Medyczne - Endoterapia /ID# 255666

location_facility: Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 252357

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 249278

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 249203

location_facility: Groupe Sante CHC - Clinique du MontLegia /ID# 248928

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 251875

location_facility: NYU Langone Long Island Clinical Research Associates /ID# 250075

location_facility: Columbia University Medical Center /ID# 250189

location_facility: Universitair Ziekenhuis Leuven /ID# 248598

location_facility: Options Health Research, LLC /ID# 249216

location_facility: Ctr for Advanced Gastroenterol /ID# 249226


acronym: NEURO – TTRANSFORM

lead_sponsor: Ionis Pharmaceuticals, Inc.

summary: To evaluate the efficacy and safety of eplontersen after administration for 65 weeks to patients with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN), as compared to the NEURO-TTR trial (NCT01737398). For more information, please visit http://www.neuro-ttransform.com/.

ReferenceCitation: Coelho T, Ando Y, Benson MD, Berk JL, Waddington-Cruz M, Dyck PJ, Gillmore JD, Khella SL, Litchy WJ, Obici L, Monteiro C, Tai LJ, Viney NJ, Buchele G, Brambatti M, Jung SW, St L O'Dea L, Tsimikas S, Schneider E, Geary RS, Monia BP, Gertz M. Design and Rationale of the Global Phase 3 NEURO-TTRansform Study of Antisense Oligonucleotide AKCEA-TTR-LRx (ION-682884-CS3) in Hereditary Transthyretin-Mediated Amyloid Polyneuropathy. Neurol Ther. 2021 Jun;10(1):375-389. doi: 10.1007/s40120-021-00235-6. Epub 2021 Feb 26.

repository_institution: California Digital Library - eScholarship

repository_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

location_facility: Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria

location_facility: University of North Carolina Hospitals - Neurology Clinic

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Indiana University School of Medicine - Indianapolis

location_facility: Centro Hospitalar Universitário do Porto - Hospital Geral de Santo Antonio

location_facility: İstanbul Üniversitesi - Istanbul Tıp Fakültesi

location_facility: Perron Institute for Neurological and Translational Science

location_facility: Johns Hopkins University Neurology Research Office

location_facility: The Cyprus Institute of Neurology and Genetics

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Azienda Ospedaliera Universitaria Policlinico Gaetano Martino

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: University General Hospital of Heraklion (PAGNI)

location_facility: Hospital Universitário Clementino Fraga Filho

location_facility: Associação de Assistência à Criança Deficiente - Unidade Lar Escola

title: A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

location_country:
Germany
Italy
Cyprus
Portugal
New Zealand
Argentina
Australia
Brazil
Sweden
United States
Spain
Greece
Turkey
Taiwan
Canada
France

ipd_sharing: No


summary: Study M15-722 is a Phase 2a study to investigate the efficacy and safety of Ravagalimab (ABBV-323) in participants with moderate to severe UC who failed prior therapy.

location_facility: Meridian Investigator Network /ID# 204646

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 208131

location_facility: NHS Greater Glasgow and Clyde /ID# 206574

location_facility: Yeungnam University Medical Center /ID# 210447

location_facility: Maastricht Universitair Medisch Centrum /ID# 204428

location_facility: Elisabeth Tweesteden Ziekenhuis /ID# 206272

location_facility: Orange County Institute of Gastroenterology and Endoscopy /ID# 207405

location_facility: Meridian Investigator Network /ID# 218568

location_facility: Penn Presbyterian Medical Center /ID# 206826

location_facility: Banner University Medical Cent /ID# 208392

location_facility: The University of Chicago DCAM /ID# 207086

location_facility: Kyungpook National University Hospital /ID# 209912

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221576

location_facility: Hospital Santa Creu i Sant Pau /ID# 213259

location_facility: Belfast Health and Social Care Trust /ID# 206744

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 208504

location_facility: Franciscus Gasthuis & Vlietland /ID# 206976

location_facility: Hospital General Universitario Gregorio Maranon /ID# 204504

location_facility: CHRU Nancy - Hôpitaux de Brabois /ID# 208133

location_facility: Universitaetsklinikum Frankfurt /ID# 207569

location_facility: Vanderbilt University Medical Center /ID# 204670

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 207571

location_facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 204689

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 221952

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 207570

location_facility: Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 204549

location_facility: Hospital Universitario La Paz /ID# 210065

title: A Multicenter, Single Arm, Open-label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

location_country:
Germany
Italy
Hungary
United Kingdom
Netherlands
United States
Korea, Republic of
Spain
Canada
France


title: A Phase 1 Open Label, Multi-Arm, Multicenter Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab for Participants With Advanced Solid Tumors

summary: This study consists of several parts: dose escalation, dose expansion, dose expansion in Chinese participants residing in China, and coformulation. Dose escalation is to evaluate the safety, tolerability, and preliminary efficacy of MK-4830 monotherapy administration (Arms A and B) and in combination with pembrolizumab (Arm C). Dose expansion is to evaluate the objective response rate (ORR) of MK-4830 in combination with pembrolizumab (Arms A-F); evaluate the safety and tolerability of MK-4830 administered in combination with pembrolizumab, carboplatin, and pemetrexed (Arm G) and of MK-4830 administered in combination with pembrolizumab and lenvatinib (Arm H); evaluate the safety, tolerability and ORR of MK-4830 in combination with pembrolizumab plus chemotherapy (Arms I-L); and evaluate the safety and tolerability of MK-4830 in combination with pembrolizumab in Chinese participants from China (Arm M). The coformulation part (Arm N) evaluates the safety and tolerability of MK-4830A (coformulation of MK-4830 800 mg + pembrolizumab 200 mg). There is no formal hypothesis testing in this study.

status: Active, not recruiting

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Siu LL, Wang D, Hilton J, Geva R, Rasco D, Perets R, Abraham AK, Wilson DC, Markensohn JF, Lunceford J, Suttner L, Siddiqi S, Altura RA, Maurice-Dror C. First-in-Class Anti-immunoglobulin-like Transcript 4 Myeloid-Specific Antibody MK-4830 Abrogates a PD-1 Resistance Mechanism in Patients with Advanced Solid Tumors. Clin Cancer Res. 2022 Jan 1;28(1):57-70. doi: 10.1158/1078-0432.CCR-21-2160. Epub 2021 Oct 1. Erratum In: Clin Cancer Res. 2022 Apr 14;28(8):1734. Clin Cancer Res. 2022 Sep 15;28(18):4158.

evidence: oa repository (via page says license)

repositories_concat: PubMed Central;aacr.figshare.com

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Poland
Israel
Australia
Japan
United States
China
Korea, Republic of
Spain
Greece
South Africa
Canada
France

location_facility: West China Hospital of Sichuan University ( Site 0804)

location_facility: The First Hospital of Jilin University ( Site 0803)

location_facility: Shanghai Chest Hospital-Oncology department ( Site 0801)

location_facility: Liverpool Hospital-Medical Oncology ( Site 0250)

location_facility: National Cancer Center Hospital East ( Site 0400)

location_facility: Uniwersyteckie Centrum Kliniczne ( Site 0151)

location_facility: Laura and Isaac Perlmutter Cancer Center ( Site 0008)

location_facility: University General Hospital of Heraklion ( Site 0110)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Cancercare Rondebosch Oncology ( Site 0210)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0042)

location_facility: Hôpital Européen Georges Pompidou ( Site 2003)

location_facility: University of California at San Francisco ( Site 0004)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0101)

location_facility: Euromedica General Clinic of Thessaloniki-Oncology Unit ( Site 0112)

location_facility: Centre Hospitalier Universitaire de Poitiers ( Site 2000)

location_facility: European Interbalkan Medical Center ( Site 0111)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005)

location_facility: Centro Integral Oncologico Clara Campal START Madrid ( Site 0102)

location_facility: Chaim Sheba Medical Center. ( Site 0044)

location_facility: Princess Alexandra Hospital ( Site 0253)

location_facility: Severance Hospital Yonsei University Health System ( Site 0300)

location_facility: South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001)

location_facility: Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 00

location_facility: Japanese Foundation for Cancer Research ( Site 0401)

location_facility: Princess Margaret Cancer Centre ( Site 0033)

location_facility: Seattle Cancer Care Alliance ( Site 0010)


title: A Phase 2, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of IPI-926 in Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma

summary: IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma.

lead_sponsor: Infinity Pharmaceuticals, Inc.

location_country:
Germany
Italy
Poland
Norway
United Kingdom
Australia
Sweden
Netherlands
Austria
United States
Canada
Russian Federation
France

location_facility: Moscow n.a. P.A Herzen Oncology Research Institute of Rosmedtechnologies

location_facility: (TGen) Translational Genomics Research Institute

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Pennsylvania Oncology Hematology Associates

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University of Miami - Sylvester Comprehensive Cancer Center

location_facility: Centre Léon Bérard, Service d'Oncologie Médicale

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


lead_sponsor: Shire

summary: The main aim of this study is to evaluate the long-term maintenance of efficacy of LDX after administered to children and adolescents aged 6-17 with ADHD for at least 6 months

ReferenceCitation: Banaschewski T, Johnson M, Lecendreux M, Zuddas A, Adeyi B, Hodgkins P, Squires LA, Coghill DR. Health-related quality of life and functional outcomes from a randomized-withdrawal study of long-term lisdexamfetamine dimesylate treatment in children and adolescents with attention-deficit/hyperactivity disorder. CNS Drugs. 2014 Dec;28(12):1191-203. doi: 10.1007/s40263-014-0193-z.

repositories_concat: PubMed Central;University of Melbourne - Minerva Access

publisher_dissemination: Springer

ReferenceCitation: Coghill DR, Banaschewski T, Lecendreux M, Johnson M, Zuddas A, Anderson CS, Civil R, Dauphin M, Higgins N, Lyne A, Gasior M, Squires LA. Maintenance of efficacy of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder: randomized-withdrawal study design. J Am Acad Child Adolesc Psychiatry. 2014 Jun;53(6):647-657.e1. doi: 10.1016/j.jaac.2014.01.017. Epub 2014 Mar 4.

repository_institution: University of Dundee - Discovery Research Portal

location_facility: Universitätsklinikum Gießen und Marburg GmbH, Universitätsklinikum Gießen und Marburg GmbH, Hans-Sachs-Straße 4,

location_facility: Universitair Ziekenhuis Gent, Kinder - en Jeugdpsychiatrie

location_facility: East Kent NHS and Social Care Partnership Trust

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Poradnia Psychiatryczna, ul. Marszalkowska 24,

location_facility: Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy

location_facility: Barn och Ungdomsmedicin klinik Mölnlycke

location_facility: Schwerpunktpraxis für Entwicklung und Lernen

location_facility: Klinikum der Johannes Gutenberg-Universität Mainz

location_facility: Zentralinstitut für Seelische Gesundheit Mannheim

location_facility: Azienda Ospedaliera Policlinico Consorziale

location_facility: ZNA Antwerpen, Commandant Weynsstraat 165

location_facility: Drottning Silvias Barnsjukhus, Otterhällegatan 12A

location_facility: Gyermek és Ifjúságpszichiátriai Szakrendelés és Gondozó

location_facility: Northampton Child and Adolescent Mental Health Services

location_facility: Wojewódzki Osrodek Lecznictwa Psychiatrycznego

location_facility: Astrid Lindgren Children's Hospital, Karolinska University Hospital

location_facility: Universität zu Köln, Klinik und Poliklinik für Psychiatrie und Psychotherapie des Kindes und Jugendalters

location_facility: Basildon Hospital - Child Development Centre,

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Praxis Dr med. Friedrich Kaiser und Dr. med. Ingrid Marinesse

location_facility: Azienda Ospedaliera della 2? Universita di Napoli

title: A Phase III, Double-blind, Placebo-controlled, Randomised Withdrawal, Multicentre, Extension, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention- Deficit/Hyperactivity Disorder (ADHD)

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Sweden
Belgium
United States
France